Large field-of-view intravascular ultrasound for actual valve-in-valve transcatheter heart valve expansion. A Pilot study. 

Large field-of-view intravascular ultrasound for actual valve-in-valve transcatheter heart valve expansion. A Pilot study. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Large field-of-view intravascular ultrasound for actual valve-in-valve transcatheter heart valve expansion. A Pilot study. Łukasz Kalińczuk, Gary S Mintz, Wiktor Skotarczak, Karol A Sadowski, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3873842/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background . Actual expansion of a transcatheter heart valve (THV) might differ from nominal particularly during non-aortic valve-in-valve (VIV) for degenerated bioprosthetic surgical heart valve (SHV). Aims. To compare THV expansion measured using large-field-of-view intravascular ultrasound (IVUS) versus multi-slice computer tomography (MSCT) and assess the correlation between THV dimensions and transvalvular gradients. Methods. Fourteen patients were successfully treated with mitral/tricuspid VIV SAPIEN 3 implantation sized using the true SHV inner diameter; all 14 had baseline MSCT and transvalvular gradients measured at baseline, post-procedure, and at discharge. Peri-procedural IVUS (in 6 patients using with a Philips 10MHz Vision PV035) was compared with post-procedural MSCT (in 9 patients) with offline measurements performed at 1-mm steps along the THV height, and analyzed 190 MSCT and paired 124 IVUS cross-sections. Results. There was very good agreement between IVUS THV dimensions and corresponding MSCT measurements (intraclass correlation coefficient ≥0.986 and p<0.001). IVUS measured THV expansion (percent of the nominal cross-sectional area) was smaller within the inflow and middle of the THV overlapping the ring (85.9±11.3%, 83.8±11.8%) than within the outflow (98.8±12.7%). The residual mean transvalvular gradient increased from peri-procedural to pre-discharge (3.5±2.0 vs 6.3±1.7mmHg, p<0.001). The only independent predictor of pre-discharge maximal transvalvular gradient was the smallest minimal inner THV frame diameter (r 2 =0.67), predicted by true SHV internal diameter (Beta = 0.066, 95%CI = 0.015 – 0.117, r 2 =0.49, p=0.037). Conclusions. Peri-procedural use of a large field-of-view IVUS offers accurate insight into actual THV expansion when deployed valve-in-valve. Minimal inner THV stent frame dimensions correlate with increased post-procedural transvalvular gradients. transcatheter valve implantation valve-in-valve procedure TMVR TTVR Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction In 60–80% of patients treated successfully with valve-in-valve (VIV) transcatheter heart valve (THV) replacement for a failed bioprosthetic surgical heart valve (SHV) in a mitral or tricuspid position, abnormally increased residual transvalvular gradients are measured in transthoracic echocardiography (TTE) before discharge, despite being within normal limits in a routine peri-procedural transoesophageal echo (TEE). Importantly, abnormally increased residual transvalvular gradients are associated with worse subsequent outcome. 1–5 A few in vitro studies reported a substantial impact of actual THV frame geometry (eccentricity/non-round shape and under-expansion) on the altered trans-valvular flow characteristics. 6–10 Large field-of-view intravascular ultrasound (IVUS) offers a unique tomographic perspective for a direct peri-procedural measure of THV stent frame and leaflet geometry. 11–15 We compared the peri-procedural IVUS assessment of SAPIEN 3 THV expansion deployed during VIV transcatheter mitral (TMVR) or tricuspid valve replacement (TTVR) versus the post-procedural multislice computed tomography (MSCT) and assessed the correlation between THV dimensions in MSCT and pre-discharge transvalvular gradients. Methods Population Analyzed were all consecutive patients treated between 4/2015 and 7/2022 with successful VIV TTVR or VIV TMVR with SAPIEN 3 THV (Edwards Lifesciences Corp., Irvine, California, USA) due to symptomatic bioprosthetic SHV structural deterioration. Out of 16 consecutive patients, 2 (12.5%) had a final residual transvalvular gradient > 3mmHg for TTVR and > 5mmHg for the TMVR VIV procedure. As a result, these procedures were deemed unsuccessful, and the patients were subsequently excluded from the study. All VIV TMVR/TTVR utilized Edwards SAPIEN 3 THVs sized upon the failed bioprosthetic SHV stent true inner diameter (ID) with a rule that selected THV nominal diameter was ≥ 2mm bigger than the corresponding stent true ID. 16 Exceptionally, single operators at their individual discretion overfilled delivery balloon volume. Since 7/2021, 6 patients had novel peri-procedural imaging using a Vision PV035 10MHz IVUS. This system offers a 60mm imaging field and tracking over a standard 0.035” guidewire (Philips North America Corporation, Andover, MA, USA) as a part of a research protocol (1748/2.4/VI/18), and all attempted were successful. Overall 9 patients had pre-discharge ECG-gated cardiac MSCT using 384-slice SOMATOM Definition Flash Dual Source (Siemens Healthcare GmbH). In every patient with peri-procedural IVUS, MSCT was done as a part of the scientific protocol, and in the remaining subjects, it was performed for clinical reasons (Fig. 1 ). All patients were Heart Team qualified; and the study complied with the Declaration of Helsinki, with all patients signing informed consent. The study was approved by the local ethics committee. Baseline demographic and clinical characteristics and procedural details were prospectively gathered and available from the hospital database. In-hospital outcomes were prospectively collected in accordance with the standardized end-point definitions by the Mitral Valve Academic Research Consortium. 17 Imaging Patients underwent pre-procedural 2D TTE (GE Vivid E95, General Electric , Boston, Massachusetts, USA) and 2D TEE (GE Vivid E95) as required with an evaluation of: ( 1 ) peak and mean transvalvular bioprosthetic gradients, ( 2 ) peri- and transvalvular regurgitation, ( 3 ) left ventricular (LV) ejection fraction and ( 4 ) tricuspid annular plane systolic excursion (TAPSE). All had pre-procedural contrast-enhanced ECG-gated cardiac MSCT to assess: ( 1 ) risk for iatrogenic LV outflow tract obstruction and ( 2 ) baseline SVH anatomy. The procedures were guided with 2D TEE (GE Vivid E95) with measurement of: ( 1 ) residual peak and mean transvalvular gradient, ( 2 ) peri- and transvalvular regurgitation, and ( 3 ) gradient across the LV outflow tract. IVUS was performed at baseline (pre-procedural) and after successful THV deployment, with manual pullback parallel to the long axis of the SHV (baseline) or the THV (post-procedural). All MSCT images were recorded and available for offline analysis using syngo.via (Siemens Healthcare GmbH). Before discharge all patients underwent 2D TTE evaluations (GE Vivid E95A) with measured peak and mean transvalvular gradients and assessment of peri- and transvalvular regurgitation. Volumetric IVUS and MSCT qualitative analysis Using the double-oblique multiplanar reconstructions with the vertical oblique plane parallel with the failed bioprosthetic SHV long axis and the transverse plane oriented at the visualized perimeter of the bioprosthetic SHV ring, pre-procedural MSCT measurements included: ( 1 ) minimal and maximal lumen IDs and cross-sectional areas and ( 2 ) inner stent (ring) minimal and maximal diameters and cross-sectional areas. Similarly, IVUS recordings were analyzed at the site of the SHV ring with the least image distortion (Fig. 2 ). The post-procedure MSCT was assessed by using a vertical oblique plane parallel to the THV long axis with a transverse plane oriented at the non-distorted THV stent frame perimeter. At 1mm steps along the entire THV height, measurements included inner and outer THV stent frame minimal and maximal diameters and cross-sectional areas. As a result, there were 18, 20, and 22 independent cross-sections for SAPIEN 3 THV 23mm, 26mm, and 29mm, respectively (Supplementary Fig. 1). We identified the IVUS loop with the best image quality after successful VIV deployment (not distorted) for THV stent frame visualization. Then we counted the total number of the following THV cross-sections recorded consistently within the known THV height; and within this number, we identified 18, 20, or 22 evenly spaced and non-distorted images that were measured the same way as MSCT images (Supplementary Fig. 2). Applying Simpson’s Rule and using the measured outer stent frame dimensions (diameters and cross-sectional areas) from MSCT and IVUS studies, we calculated: ( 1 ) average THV outer stent frame volume (cm 3 ) and ( 2 ) minimal and maximal diameters (mm). These calculations were made per the entire THV height and independently per its inflow, mid (coaptation region), and outflow. The valve inflow height was equal to the outer skirt height (6.0mm, 7.0mm, and 8.1mm for 23mm, 26mm, and 29mm valves, respectively), and the valve mid height was considered as the difference between the corresponding outer and inner skirt heights (inner skirt heights: 9.3mm, 10.2mm, and 11.6mm for 23mm, 26mm, and 29mm valves, respectively). The THV outflow height was the overall stent frame height minus the inner skirt height. 18 The average/minimal percentage (%) expansion of the THV stent frame in relation to nominal THV dimensions was calculated as the actually measured average/minimal outer sent frame volume/cross-sectional area divided by the corresponding nominal outer stent frame average volume/cross-sectional area x 100%. The nominal SAPIEN 3 THV outer stent frame cross-sectional area was derived from published studies that measured it with microCT after the valve expansion on air using the transfemoral Edwards Commander delivery system (Edwards Lifesciences) filled with a nominal volume of fluid. 19,20 The average % expansion was calculated for the entire THV height and separately for its inflow, mid, and outflow. Additionally calculated was % oversizing of the THV stent frame in relation to SHV (nominal THV outer stent frame area/SHV inner ring true area x 100% ̶ 100%). 16 THV eccentricity was calculated as max/min outer stent frame diameters. Statistical analysis Categorical data are presented as numbers and frequencies and compared with the Pearson chi-square statistics. The one-sample Kolmogorov-Smirnov test was used to verify the distribution (normal vs nonuniform) of continuous parameters. Normally distributed variables were presented as means ± standard deviation and compared using the Paired-Samples T-test with computed Pearson correlation coefficients. Continuous variables with non-normal distributions presented are as medians with an interquartile range. Multivariate linear regression was used to search for independent correlates of ( 1 ) minimal THV inner stent frame area (measured using MSCT), ( 2 ) maximal transvalvular gradient measured pre-discharge, and ( 3 ) the smallest minimal inner THV stent frame diameter measured using post-procedural MSCT, with computed parameter estimate and corresponding 95% confidence interval (Beta and 95%CI). Inter- and intra-observer variability in IVUS measurements were assessed with intraclass correlation coefficients. The reproducibility of the corresponding IVUS versus MSCT measurements was analyzed using the Bland-Altman plot analysis and calculated intraclass correlation coefficients. The limits of agreement were defined as mean ± 1.96 SD of absolute difference. P < 0.05 was considered significant. Statistical analysis was performed using the PASW Statistics 18 (IBM Corporation, Armonk, New York, USA). Results Demographics and baseline clinical data . In the overall studied cohort (n = 14) of consecutive patients treated with mitral/tricuspid VIV SAPIEN 3 THV implantation average age was 62.0 ± 18.5 years, most were female (71.4%), and most (92.9%) were categorized as surgical high-risk; the degenerated bioprosthesis was mitral in 42.9% and tricuspid in 57.1% (Table 1 ). In 50% of patients, the dominant bioprosthesis failure mode was mixed stenosis and regurgitation with nominal bioprosthesis size being ≥ 29mm in 78.6%. Bioprostheses type distribution is shown in Table 1 . Table 1 Baseline clinical, echocardiographic and MSCT characteristics. All patients (n = 14) Demographics and clinics Age, years 62.0 ± 18.5 Female, n (%) 10 (71.4) Body mass index, kg/m 2 27.1 ± 5.9 EuroSCORE II, % 10.6 ± 5.6 EuroSCORE II > 4% 13 (92.9) Permanent pacemaker, n (%) 4 (28.6) Atrial fibrillation, n (%) 10 (71.4) Previous myocardial infarction, n (%) 2 (14.3) Previous percutaneous coronary intervention, n (%) 1 (7.1) Previous coronary bypass surgery, n (%) 0 (0) Previous stroke/TIA, n (%) 1 (7.1) Diabetes mellitus, n (%) 6 (42.8) Hypertension, n (%) 5 (35.7) Dyslipidemia, n (%) 5 (35.7) Chronic renal disease, n (%) 9 (64.3) Chronic obstructive lung disease, n (%) 0 (0) Dysfunctional bioprosthesis Dysfunctional bioprosthesis in mitral position 6 (42.9) Dysfunctional bioprosthesis in tricuspid position 8 (57.1) Standard 3rd generation Carpentier-Edwards stented bovine valve 2 (14.3) Carpentier-Edwards PERIMOUNT Plus stented bovine valve 1 (7.1) Carpentier-Edwards PERIMOUNT Magna Ease stented bovine valve 1 (7.1) Medtronic Mosaic bioprosthesis 3 (21.4) Medtronic Hancock II porcine bioprosthesis 4 (28.6) St Jude Medical Biocor valve 2 (14.3%) Abbott Epic heart valve 1 (7.1) Nominal outer bioprosthesis diameter 27 mm 3 (21.4) Nominal outer bioprosthesis diameter 29 mm 4 (28.6) Nominal outer bioprosthesis diameter 31 mm 7 (50.0) Mean nominal outer bioprosthesis diameter, mm 27.4 ± 2.1 Mean bioprosthesis stent true ID, mm 25.4 ± 2.1 Duration since surgical insertion, y 10.5 (9.0-19.5) Baseline echocardiography Transvalvular bioprosthetic gradient (peak), mmHg 20.5 ± 7.5 Transvalvular bioprosthetic gradient (mean), mmHg 10.1 ± 9.2 Bioprosthetic dominant stenosis 3 (21.4) Bioprosthetic dominant regurgitation 4 (28.6) Bioprosthetic mixed stenosis and regurgitation 7 (50.0) LV ejection fraction, % 55.1 ± 10.8 TAPSE, mm 12.9 ± 3.7 Baseline MSCT findings Minimal bioprosthetic SHV stent ID, mm 26.3 ± 1.4 Maximal bioprosthetic SHV stent ID, mm 27.5 ± 1.8 Minimal lumen ID at the site of the bioprosthetic ring, mm 22.4 ± 3.4 Maximal lumen ID at the site of the bioprosthetic ring, mm 23.6 ± 3.1 Procedural data . There was significant correlation between SHV stent true ID and nominal THV diameter (r = 0.865 and p < 0.001) with a nominal THV diameter that was oversized compared to the corresponding stent true ID (27.7 ± 1.9 vs 25.4 ± 2.1 mm, p 2mm bigger than the corresponding SHV stent true ID and > 20% inner ring area oversizing in 6 patients (42.9%). SAPIEN 3 THV was deployed with nominal delivery balloon volume except three patients (21.4%) in whom operators at their own discretion overfilled it by 10%, mostly without preceding valvuloplasty (92.9%) and without post-dilation. Minor PVL and minor residual trans-valvular regurgitation were observed in 6 (42.9%) and 5 (35.7%) patients, respectively, with 3 (21.4%) having both. The in-hospital course of all patients was uneventful except for 1 extensive bleeding associated with vascular access requiring surgical intervention. In all patients, pre-discharge transvalvular gradients were bigger than peri-procedural measures with their maximal values of 14.9 ± 3.7mmHg and 7.5 ± 2.4mmHg, respectively (Table 2 ). Table 2 Procedural data. All patients (n = 14) General anesthesia with intubation 13 (92.9) Conscious sedation and local anesthesia 1 (7.1) Transseptal access in TMVR 6 (100) Cerebral protection device (Sentinel) 1 (7.1) SAPIEN 3 THV 23 mm 1 (7.1) SAPIEN 3 THV 26 mm 4 (28.6) SAPIEN 3 THV 29 mm 9 (64.3) Nominal delivery balloon volume 8 (57.1) Overfilling delivery balloon volume * 3 (21.4%) Preceding valvuloplasty 1 (7.1) True inner SHV ring area oversizing, % 19.7 ± 10.2 Residual peak transvalvular gradient, mmHg 6.7 ± 1.7 Residual mean transvalvular gradient, mmHg 3.5 ± 2.0 Minor paravalvular leak (trace/mild) 6 (42.9) Residual transvalvular minor (trace/mild) regurgitation 5 (35.7) Minor paravalvular and minor transvalvular leak/regurgitation 3 (21.4) Contrast agent volume, ml 50 (22.5–90.0) Fluoroscopy time, min 20.7 (17.2–44.1) Radiation, mGy 767.0 (401.5-2081.5) * using an extra fluid ≥ 10% of the nominal inflation volume Baseline MSCT and IVUS results. Minimal and maximal bioprosthetic SHV stent (ring) ID measured using baseline MSCT (n = 14) were similar to the nominal (p = 0.114 and p = 0.864; respectively); whereas minimal and maximal lumen ID measured at the site of the bioprosthetic SHV ring were smaller than the corresponding stent true ID (p = 0.005 and p = 0.056; respectively). The nominal THV diameter was larger than the corresponding minimal and maximal lumen ID (p < 0.001 for both), but was similar to the measured in baseline MSCT nominal and maximal bioprosthetic SHV stent ID (p = 0.239 and p = 0.774; respectively)(Table 1 ). Baseline IVUS measurements (n = 6) corresponded well with the respective MSCT dimensions (Table 3 ). Table 3 Comparison of the corresponding results of IVUS and MSCT measurements, obtained at baseline at the site of failed SVH ring and after the VIV procedure at 1-mm step along the entire SAPIEN 3 THV height with assessed outer stent frame dimensions (the Paired-Samples T Test with computed Pearson correlation coefficients). IVUS MSCT correlation p-value Baseline Planar measurements at the site of failed SHV ring (n = 6) Min lumen diameter, mm 21.1 ± 3.4 21.1 ± 3.4 0.995 < 0.001 Max lumen diameter, mm 22.2 ± 3.1 22.1 ± 3.1 0.985 < 0.001 Lumen area, cm 2 3.78 ± 0.92 3.83 ± 0.96 0.997 < 0.001 Stent minimal ID, mm 25.9 ± 1.3 26.1 ± 1.0 0.978 0.004 Stent maximal ID, mm 27.1 ± 1.8 27.0 ± 2.1 0.962 0.009 Stent inner area, cm 2 5.37 ± 0.57 5.39 ± 0.53 0.998 < 0.001 Post VIV THV replacement (immediately in IVUS and subsequently in MSCT) Entire SAPIEN 3 THV height (n = 6) Minimal diameter, cm 2.55 ± 0.24 2.58 ± 0.24 0.992 < 0.001 Maximal diameter, cm 2.79 ± 0.27 2.73 ± 0.29 0.992 < 0.001 Outer frame stent volume, cm 3 5.61 ± 1.06 5.57 ± 1.08 0.999 < 0.001 Expansion, % 91.9 ± 11.6 91.2 ± 11.4 0.998 < 0.001 THV eccentricity 1.09 ± 0.03 1.06 ± 0.03 0.676 0.141 SAPIEN 3 THV inflow (n = 6) Minimal diameter, cm 2.45 ± 0.23 2.50 ± 0.23 0.992 < 0.001 Maximal diameter, cm 2.72 ± 0.28 2.64 ± 0.32 0.976 0.001 Outer frame stent volume, cm 3 5.25 ± 1.01 5.20 ± 1.02 0.998 < 0.001 Expansion, % 86.2 ± 11.9 85.2 ± 11.5 0.997 < 0.001 THV eccentricity 1.11 ± 0.03 1.05 ± 0.05 0.626 0.184 SAPIEN 3 THV mid segment (n = 6) Minimal diameter, cm 2.48 ± 0.27 2.46 ± 0.27 0.965 0.002 Maximal diameter, cm 2.67 ± 0.26 2.61 ± 0.28 0.964 0.002 Outer frame stent volume, cm 3 5.11 ± 1.03 5.10 ± 1.07 0.995 < 0.001 Expansion, % 83.8 ± 12.4 83.5 ± 12.7 0.995 < 0.001 THV eccentricity 1.08 ± 0.05 1.06 ± 0.01 0.020 0.969 SAPIEN 3 THV outflow (n = 6) Minimal diameter, cm 2.65 ± 0.25 2.68 ± 0.25 0.991 < 0.001 Maximal diameter, cm 2.90 ± 0.27 2.84 ± 0.28 0.990 < 0.001 Outer frame stent volume, cm 3 6.04 ± 1.12 6.01 ± 1.13 0.998 < 0.001 Expansion, % 98.8 ± 12.8 98.3 ± 12.4 0.991 < 0.001 THV eccentricity 1.09 ± 0.04 1.06 ± 0.03 0.736 0.096 Post-procedural MSCT, peri-procedural IVUS, and pre-discharge TTE results . Overall, 190 THV cross-sections were analyzed in MSCT and 124 in IVUS. There was a good correlation between all the volumetric THV outer frame dimensions measured by IVUS versus MSCT (Table 3 , Fig. 3 ). The actual outer-frame expansion was smaller within the lengths of inflow and mid-THV height (overlapping the ring) than in the outflow, being substantially smaller than nominal (83.3 ± 12.1% and 81.8 ± 11.8% and 95.7 ± 12.1% in MSCT versus 85.9 ± 11.3% and 83.8 ± 11.8% and 98.8 ± 12.7% in IVUS; respectively, Fig. 4 ). There were high inter- and intra-observer agreement in IVUS measurements (Supplementary Table 1). Comparing 248 corresponding pairs of inner and outer-stent frame THV cross-sectional measurements (minimal and maximal diameters and cross-sectional areas) made using IVUS and MSCT, there was a good agreement (intraclass correlation coefficient from 0.990 to 0.999, Fig. 5 , Supplementary Table 2). The minimal percentage of THV expansion measured using MSCT and IVUS were 80.1 ± 10.0% and 79.0 ± 11.1%, respectively, with corresponding minimal inner SAPIEN 3 THV frame area of 3.47 ± 0.78cm 2 and 3.22 ± 0.62cm 2 . The degree of the % THV oversizing in relation to SHV correlated inversely with a minimal % THV expansion in relation to nominal size measured in both IVUS and MSCT (r=-0.876, p = 0.002 and r=-0.86, p = 0.026; respectively); but minimal inner THV stent frame area was independently predicted only by stent true ID (Beta = 0.313, 95%CI = 0.183–0.442, r 2 = 0.823, p = 0.001). The only independent predictor of the maximal transvalvular gradient measured pre-discharge was the smallest minimal inner THV frame diameter (r 2 = 0.67, Table 4 ), which was predicted by the true bioprosthetic SHV stent ID (Beta = 0.066, 95%CI = 0.015–0.117, r 2 = 0.49, p = 0.037). Table 4 Correlates of maximal transvalvular gradient measured pre-discharge. Univariate Multivariable Beta 95%CI p-value Beta 95%CI p-value True stent ID (n = 14) -1.062 -1.928 ̶ -0.195 0.020 - - - Nominal SAPIEN 3 THV diameter (n = 14) -0.873 -1.932 ̶ 0.186 0.098 - - - Minimal lumen diameter measured in baseline MSCT at the site of bioprosthetic SVH ring (n = 14) -0.126 -0.735 ̶ 0.486 0.694 - - - % SAPIEN 3 THV outer stent frame area oversizing (n = 14) 0.153 -0.052 ̶ 0.359 0.130 - - - Minimal % expansion of SAPIEN 3 THV outer frame in MSCT (n = 9) -2.693 -24.776 ̶ 19.390 0.818 - - - Minimal inner SAPIEN 3 THV stent frame area (n = 9) -2.766 -5.179 ̶ -0.353 0.030 - - - The smallest minimal inner SAPIEN 3 THV stent frame diameter measured in post-procedural MSCT (n = 9) -11.495 -18.783 ̶ -4.207 0.007 − 11.495 -18.783 ̶ -4.207 0.007 Discussion Optimal THV leaflet function requires the stent frame to be fully expanded (100% nominal) and circular. 7,21,22 Peri-procedural angiographic guidance of THV stent frame expansion, including rotational 3D angiography, 15 has limitations due to visual resolution and projection angles (the short axis of the valve is often unattainable with fluoroscopy). TEE visual resolution is also limited; it is used less and less ("minimalist THV deployment") and is hampered by acoustic shadows and poor imaging windows. Peri-procedural Doppler measurements, including those with TEE, are often biased, with subsequent values frequently higher. 23 With this background, the current study is the first to use IVUS to assess actual SAPIEN 3 THV stent frame expansion immediately following successful TMVR or TTVR VIV. The major findings of the current study are as follows. ( 1 ) Expansion was significantly smaller than nominal, especially where it overlaps with the bioprosthetic SHV ring. ( 2 ) IVUS findings were comparable to the current gold standard MSCT assessment. ( 3 ) Minimal inner SAPIEN 3 THV stent frame dimensions correlated directly with increased transvalvular gradients recorded pre-discharge. For example, other authors using MSCT studies of early dysfunctional THVs (less than one year since deployment) found stent frame under-expansion in the THV inflow and midportion that was corrected with subsequent dilatations using a non-compliant tubular balloon with a diameter equal to the nominal THV size. 24 This could have been prevented with intraprocedural IVUS guidance. In a previous pig model, the authors inserted 26mm SAPIEN 3 THVs into stented bioprosthetic SHVs with varying inner diameters following the VIV Mitral app’s recommendation of a nominal THV diameter 2mm larger than the SHV inner diameter. 25,26 Despite our study having a smaller THV oversizing percentage than the pig model, the actual inflow and outflow expansion percentages were larger. This underscores the importance of peri-procedural insights into the actual results over the pre-procedural planning. In an in vitro analysis of mitral hemodynamic performance after VIV deployment of first-generation SAPIEN THV into brand-new surgical bioprostheses, the authors found that VIV deployment was associated with increased transvalvular gradients, particularly in bioprostheses with small stent true ID and higher % oversizing, aligning with the VIVID Registry findings. 27,28 In the current analysis, only the bioprosthesis stent true ID remained an independent correlate of minimal inner SAPIEN 3 THV stent frame dimension. Although maximal transvalvular gradients measured pre-discharge in the current study were bigger for smaller bioprostheses, it was the measured minimal inner SAPIEN 3 THV stent frame diameter that independently explained 67% of its variability. The current results suggest that in the lifelong management of transcatheter heart valve replacements, including aortic procedures with a significant readmissions rate, accurate peri-procedural insights using IVUS hold great potential for guiding the process, both at the initial and redo levels). This complements detailed pre-procedural planning using baseline MSCT and bench tests results. 29–32 Potential for improved procedural outcomes may justify the cost of incorporating IVUS equipment. Its integration into THV procedures may add to the overall procedural time, and it would be essential to weigh the benefits of real-time guidance and precise measurements against delays. Study Limitations. This is a proof-of-concept study of a small number of patients. Two patients were excluded due to high residual gradients measured during the procedure, but we couldn’t evaluate the expansion of their stent frames because we didn’t do IVUS or MSCT. We expect that a future multi-center investigator-initiated research will provide a more thorough analysis of our findings. The accuracy of our results might be influenced by the non-coaxial IVUS transducer location. Significant errors can occur when the transducer is angled more than 25 degrees off-center, but this can be corrected with gentle wire adjustments (e.g. right ventricle loop or pulmonary artery wire position during TTVR VIV) and use of steerable sheaths. 33 Technological advancements should automate IVUS pullback and reduce variability caused by the transducer location. The Edwards Commander Delivery system comes with a compliant balloon. If this balloon is inflated at the rigid ring with a substantially smaller inner dimension, it may unevenly distribute the inflation fluid toward areas with less resistance, affecting the actual stent frame expansion. Overfilling the balloon can enhance this issue. We didn’t adjust nominal SAPIEN 3 THV dimensions to account for this overfilling. 19 Importantly, none of the valves was cracked/remodeled, but IVUS seems to be a helpful for guiding these, even for non-aortic valves. 34 Conclusions Peri-procedural use of a large field-of-view IVUS offers accurate and online measurements of actual expansion of SAPIEN 3 THVs deployed for valve-in-valve enabling clinicians to make real-time, data-driven decisions to enhance outcomes. Measured minimal inner THV stent frame dimensions correspond with increased post-procedural transvalvular gradients and post-dilatation of the stent frame might be justified in such cases. Abbreviations ID = inner diameter IVUS = intravascular ultrasound LV = left ventricular MSCT = multi-slice computer tomography PVL = paravalvular leak SHV = surgical heart valve TEE = transoesophageal echocardiography THV = transcatheter heart valve TMVR = transcatheter mitral valve replacement TTE = transthoracic echocardiography TTVR = transcatheter tricuspid valve replacement VIV = valve-in-valve Declarations Author Contribution All authors reviewed the manuscriptŁukasz Kalińczuk and Marcin Demkow performed the procedureWiktor Skotarczak, Karol A Sadowski, Patrycjusz Stokołosa, Sara Kochańska - wrote the main manuscript textMaciej Dąbrowski, Olgierd Woźniak - prepared figuresAgata Kubik, Ilona Kowalik - patient qualificationAdam Witkowski, Ilona Michałowska - prepared tablesGary S Mintz, Lars Sondergaard - senio author Author disclosures: Authors did not report conflicts of interest related to the presented study. 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An in vitro evaluation of the impact of eccentric deployment on transcatheter aortic valve hemodynamics. Ann Biomed Eng. 2014;42:1195-1206. Sirois E, Mao W, Li K, Calderan J, Sun W. Simulated Transcatheter Aortic Valve Flow: Implications of Elliptical Deployment and Under-Expansion at the Aortic Annulus. Artif Organs. 2018;42:E141-E152. Kuetting M, Sedaghat A, Utzenrath M, Sinning JM, Schmitz C, Roggenkamp J, Werner N, Schmitz-Rode T, Steinseifer U. In vitro assessment of the influence of aortic annulus ovality on the hydrodynamic performance of self-expanding transcatheter heart valve prostheses. J Biomech. 2014;47:957-965. Hatoum H, Yousefi A, Lilly S, Maureira P, Crestanello J, Dasi LP. An in vitro evaluation of turbulence after transcatheter aortic valve implantation. J Thorac Cardiovasc Surg. 2018;156:1837-1848. Komoriyama H, Kamiya K, Nagai T, Oyama-Manabe N, Tsuneta S, Kobayashi Y, Kato Y, Sarashina M, Omote K, Konishi T, Sato T, Tsujinaga S, Iwano H, Shingu Y, Wakasa S, Anzai T. Blood flow dynamics with four-dimensional flow cardiovascular magnetic resonance in patients with aortic stenosis before and after transcatheter aortic valve replacement. J Cardiovasc Magn Reson. 2021;23:81. Skotarczak W, Kalińczuk Ł, Mintz GS, Demkow M. Large field-of-view intravascular ultrasound for peri-procedural tomographic insights into valve-in-valve frame expansion. Eur Heart J Case Rep. 2022;6:ytac284. Kalińczuk Ł, Hoffman P, Mintz GS, Demkow M. Valve geometry assessment during transcatheter tricuspid valve replacement offered by large field-of-view intravascular ultrasound. Eur Heart J Case Rep. 2022;6:ytac166. Kalińczuk Ł, Mintz GS, Zieliński K, Dąbrowski M, Witkowski A. Intravascular Ultrasound for Valve-in-Valve Guidance During Repeat Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2022;15:e61-e62. Kalińczuk Ł, Mintz GS, Chmielak Z, Rudziński PN, Witkowski A. Intraprocedural assessment of valve geometry during transcatheter mitral valve replacement by large field-of-view intravascular ultrasound: a case report. Eur Heart J Case Rep. 2021;5:ytab508. Kalińczuk Ł, Chmielak Z, Zieliński K, Khan J, Dąbrowski M, Świerczewski M, Michałowska I, Demkow M, Witkowski A, Mintz GS. Intravascular ultrasound online guidance during transcatheter valve replacement for native aortic stenosis or failed bioprosthesis. Kardiol Pol. 2020;78:762-765. Bapat V. Valve-in-valve apps: why and how they were developed and how to use them. EuroIntervention. 2014;10 Suppl U:U44-51. Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS, Abraham WT, Adams DH, Anker S, Argenziano M, Baumgartner H, Bax JJ, Blackstone EH, Bolling SF, Bonow RO, Borer JS, Brennan J, Cutlip DE, Dion RA, Feldman TE, Filippatos G, Généreux P, Grayburn PA, Head SJ, Kappetein AP, Krucoff MW, Kuck KH, Lancellotti P, Leon MB, Lindenfeld J, Mack MJ, McCarthy PM, Mehran R, Piazza N, Enriquez-Sarano M, Schofer J, Schwartz A, Siegel RJ, Stone GW, Vahanian AS, Vranckx P. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015;36:1878-1891. Yudi MB, Sharma SK, Tang GHL, Kini A. Coronary Angiography and Percutaneous Coronary Intervention After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2018;71:1360-1378. Sathananthan J, Sellers S, Barlow A, Fraser R, Stanová V, Cheung A, Ye J, Alenezi A, Murdoch DJ, Hensey M, Dvir D, Blanke P, Rieu R, Wood D, Pibarot P, Leipsic J, Webb J. Overexpansion of the SAPIEN 3 Transcatheter Heart Valve: An Ex Vivo Bench Study. JACC Cardiovasc Interv. 2018;11:1696-1705. Ihdayhid AR, Leipsic J, Hahn RT, Pibarot P, Thourani V, Makkar R, Kodali S, Russo M, Kapadia S, Chen Y, Mack M, Webb J, Bax J, Leon MB, Blanke P. Impact of Annular Oversizing on Paravalvular Regurgitation and Valve Hemodynamics: New Insights From PARTNER 3. JACC Cardiovasc Interv. 2021;14:2158-2169. Fukui M, Bapat VN, Garcia S, Dworak MW, Hashimoto G, Sato H, Gössl M, Enriquez-Sarano M, Lesser JR, Cavalcante JL, Sorajja P. Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes. Circulation. 2022;146:480-493. PMA P140031: FDA Summary of Safety and Effectiveness Data of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System. Accessed December 14, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031b.pdf Whisenant B, Kapadia SR, Eleid MF, Kodali SK, McCabe JM, Krishnaswamy A, Morse M, Smalling RW, Reisman M, Mack M, O'Neill WW, Bapat VN, Leon MB, Rihal CS, Makkar RR, Guerrero M. One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve. JAMA Cardiol. 2020;5:1245-1252. Akodad M, Blanke P, Chuang MA, Duchscherer J, Sellers SL, Chatfield AG, Gulsin GG, Lauck S, Leipsic JA, Meier D, Moss RR, Cheung A, Sathananthan J, Wood DA, Ye J, Webb JG. Late Balloon Valvuloplasty for Transcatheter Heart Valve Dysfunction. J Am Coll Cardiol. 2022;79:1340-1351. Wang DD, O'Neill BP, Caranasos TG, Chitwood WR, Stack RS, O'Neill WW. Comparative differences of mitral valve-in-valve implantation: A new mitral bioprosthesis versus current mosaic and epic valves. Catheter Cardiovasc Interv. 2022;99:934-942. Pirelli L, Hong E, Steffen R, Vahl TP, Kodali SK, Bapat V. Mitral valve-in-valve and valve-in-ring: tips, tricks, and outcomes. Ann Cardiothorac Surg. 2021;10:96-112. Evin M, Guivier-Curien C, Rieu R, Rodés-Cabau J, Pibarot P. Mitral valve-in-valve hemodynamic performance: An in vitro study. J Thorac Cardiovasc Surg. 2016;151:1051-9.e6. Simonato M, Whisenant B, Ribeiro HB, Webb JG, Kornowski R, Guerrero M, Wijeysundera H, Søndergaard L, De Backer O, Villablanca P, Rihal C, Eleid M, Kempfert J, Unbehaun A, Erlebach M, Casselman F, Adam M, Montorfano M, Ancona M, Saia F, Ubben T, Meincke F, Napodano M, Codner P, Schofer J, Pelletier M, Cheung A, Shuvy M, Palma JH, Gaia DF, Duncan A, Hildick-Smith D, Veulemans V, Sinning JM, Arbel Y, Testa L, de Weger A, Eltchaninoff H, Hemery T, Landes U, Tchetche D, Dumonteil N, Rodés-Cabau J, Kim WK, Spargias K, Kourkoveli P, Ben-Yehuda O, Teles RC, Barbanti M, Fiorina C, Thukkani A, Mackensen GB, Jones N, Presbitero P, Petronio AS, Allali A, Champagnac D, Bleiziffer S, Rudolph T, Iadanza A, Salizzoni S, Agrifoglio M, Nombela-Franco L, Bonaros N, Kass M, Bruschi G, Amabile N, Chhatriwalla A, Messina A, Hirji SA, Andreas M, Welsh R, Schoels W, Hellig F, Windecker S, Stortecky S, Maisano F, Stone GW, Dvir D. Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry. Circulation. 2021;143:104-116. Sathananthan J, Fraser R, Landes U, Rich C, Sellers SL, Leipsic J, Blanke P, Lutter G, Frank D, Puehler T, Wood DA, Søndergaard L, Webb JG. Repeat transcatheter aortic valve implantation and implications for transcatheter heart valve performance: insights from bench testing. EuroIntervention. 2021;17:856-864. Perdoncin E, Bruce CG, Babaliaros VC, Yildirim DK, Depta JP, McCabe JM, Gleason PT, Xie J, Grubb KJ, Paone G, Kohli K, Kamioka N, Khan JM, Rogers T, Lederman RJ, Greenbaum AB. Balloon-Augmented Leaflet Modification With Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction and Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction: Benchtop Validation and First In-Man Experience. Circ Cardiovasc Interv. 2021;14:e011028.36. Sathananthan J, Sellers S, Barlow A, Fraser R, Stanová V, Cheung A, Ye J, Alenezi A, Murdoch DJ, Hensey M, Dvir D, Blanke P, Rieu R, Wood D, Pibarot P, Leipsic J, Webb J. Overexpansion of the SAPIEN 3 Transcatheter Heart Valve: An Ex Vivo Bench Study. JACC Cardiovasc Interv. 2018;11:1696-1705. Majmundar M, Doshi R, Kumar A, Johnston D, Brockett J, Kanaa'N A, Lahorra JA, Svensson LG, Krishnaswamy A, Reed GW, Puri R, Kapadia SR, Kalra A. Valve-in-valve transcatheter aortic valve implantation versus repeat surgical aortic valve replacement in patients with a failed aortic bioprosthesis. EuroIntervention. 2022;17:1227-1237. Geselschap JH, Heilbron MJ, Hussain FM, Daskalakis TM, Wilson EP, Kopchok GE, White RA. The effect of angulation on intravascular ultrasound imaging observed in vascular phantoms. J Endovasc Surg. 1998;5:126-133. Krishnaswamy A, Kaur S, Isogai T, Zhou L, Shekhar S, Yun J, Unai S, Burns D, Kapadia S. Minimalist Mitral Valve-in-Valve Replacement Using Conscious Sedation and Intracardiac Echocardiography Is Feasible and Safe. JACC Cardiovasc Interv. 2022;15:1288-1290. Additional Declarations No competing interests reported. Supplementary Files SupplementaryFigure1.docx SupplementaryFigure2.docx SupplementaryTable1.docx SupplementaryTable2.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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Relevant and corresponding measurements are shown in IVUS and MSCT.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/b8fc42d9df4effcba849252a.png"},{"id":49975817,"identity":"f5992f2f-261d-4ed8-ad2a-e8fe0d401503","added_by":"auto","created_at":"2024-01-22 14:48:27","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":308622,"visible":true,"origin":"","legend":"\u003cp\u003eAn\u003cstrong\u003e \u003c/strong\u003eexample of the corresponding\u003cstrong\u003e \u003c/strong\u003eIVUS and MSCT SAPIEN 3 THV inner and outer frame measurements (IVUS transducer location is marked with asterisk).\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/f1544205175e1aac7c33c1b4.png"},{"id":49975818,"identity":"edeece06-1ebc-4ce2-bc3f-baf6cd6b2b33","added_by":"auto","created_at":"2024-01-22 14:48:27","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":81169,"visible":true,"origin":"","legend":"\u003cp\u003e% Expansion of SAPIEN 3 THVs measured in IVUS and MSCT.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/3395a6c464e941ae2ed934b6.png"},{"id":49977782,"identity":"b5989c38-5d0e-45d1-bb9a-1f8b4eb3c300","added_by":"auto","created_at":"2024-01-22 14:56:27","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":174637,"visible":true,"origin":"","legend":"\u003cp\u003ePlots of differences between corresponding inner and outer-frame IVUS and MSCT measurements vs the mean of the two measurements (IVUS and MSCT), with marked the limits of agreement from -1.96 x SD +1.96 x SD (doted lines).\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/1be4e3e9cbb4bb8ae0d3ab64.png"},{"id":51322350,"identity":"63bf167d-2bb6-44c1-98de-c3554a9c9f6e","added_by":"auto","created_at":"2024-02-19 14:52:40","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1505015,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/9b0b9944-7799-49b1-8c41-c7b42fc3b7ef.pdf"},{"id":49977781,"identity":"6df989dc-6fd8-4ea1-a16f-798f5ec013ab","added_by":"auto","created_at":"2024-01-22 14:56:27","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":203581,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFigure1.docx","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/09021e5fc01ee72e88dea2ab.docx"},{"id":49975819,"identity":"e46a3efe-5a49-4df8-adb3-8a2c26008dbe","added_by":"auto","created_at":"2024-01-22 14:48:27","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":401361,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFigure2.docx","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/d8f930f10fc8aac34c249eca.docx"},{"id":49975821,"identity":"678ed686-e782-42b4-b4c0-9eed550efee6","added_by":"auto","created_at":"2024-01-22 14:48:27","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":31861,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryTable1.docx","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/4a88d9a749ad753e0cd996e9.docx"},{"id":49975822,"identity":"4c37e200-f01c-4f4e-8c94-28d0eff3e81e","added_by":"auto","created_at":"2024-01-22 14:48:27","extension":"docx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":30456,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryTable2.docx","url":"https://assets-eu.researchsquare.com/files/rs-3873842/v1/13bd282b6c913ff7abaf26c8.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Large field-of-view intravascular ultrasound for actual valve-in-valve transcatheter heart valve expansion. A Pilot study. ","fulltext":[{"header":"Introduction","content":"\u003cp\u003eIn 60\u0026ndash;80% of patients treated successfully with valve-in-valve (VIV) transcatheter heart valve (THV) replacement for a failed bioprosthetic surgical heart valve (SHV) in a mitral or tricuspid position, abnormally increased residual transvalvular gradients are measured in transthoracic echocardiography (TTE) before discharge, despite being within normal limits in a routine peri-procedural transoesophageal echo (TEE). Importantly, abnormally increased residual transvalvular gradients are associated with worse subsequent outcome.\u003csup\u003e1\u0026ndash;5\u003c/sup\u003e A few \u003cem\u003ein vitro\u003c/em\u003e studies reported a substantial impact of actual THV frame geometry (eccentricity/non-round shape and under-expansion) on the altered trans-valvular flow characteristics.\u003csup\u003e6\u0026ndash;10\u003c/sup\u003e Large field-of-view intravascular ultrasound (IVUS) offers a unique tomographic perspective for a direct peri-procedural measure of THV stent frame and leaflet geometry.\u003csup\u003e11\u0026ndash;15\u003c/sup\u003e We compared the peri-procedural IVUS assessment of SAPIEN 3 THV expansion deployed during VIV transcatheter mitral (TMVR) or tricuspid valve replacement (TTVR) versus the post-procedural multislice computed tomography (MSCT) and assessed the correlation between THV dimensions in MSCT and pre-discharge transvalvular gradients.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePopulation\u003c/h2\u003e \u003cp\u003eAnalyzed were all consecutive patients treated between 4/2015 and 7/2022 with successful VIV TTVR or VIV TMVR with SAPIEN 3 THV (Edwards Lifesciences Corp., Irvine, California, USA) due to symptomatic bioprosthetic SHV structural deterioration. Out of 16 consecutive patients, 2 (12.5%) had a final residual transvalvular gradient\u0026thinsp;\u0026gt;\u0026thinsp;3mmHg for TTVR and \u0026gt;\u0026thinsp;5mmHg for the TMVR VIV procedure. As a result, these procedures were deemed unsuccessful, and the patients were subsequently excluded from the study. All VIV TMVR/TTVR utilized Edwards SAPIEN 3 THVs sized upon the failed bioprosthetic SHV stent true inner diameter (ID) with a rule that selected THV nominal diameter was \u0026ge;\u0026thinsp;2mm bigger than the corresponding stent true ID.\u003csup\u003e16\u003c/sup\u003e Exceptionally, single operators at their individual discretion overfilled delivery balloon volume. Since 7/2021, 6 patients had novel peri-procedural imaging using a Vision PV035 10MHz IVUS. This system offers a 60mm imaging field and tracking over a standard 0.035\u0026rdquo; guidewire (Philips North America Corporation, Andover, MA, USA) as a part of a research protocol (1748/2.4/VI/18), and all attempted were successful. Overall 9 patients had pre-discharge ECG-gated cardiac MSCT using 384-slice SOMATOM Definition Flash Dual Source (Siemens Healthcare GmbH). In every patient with peri-procedural IVUS, MSCT was done as a part of the scientific protocol, and in the remaining subjects, it was performed for clinical reasons (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). All patients were Heart Team qualified; and the study complied with the Declaration of Helsinki, with all patients signing informed consent. The study was approved by the local ethics committee.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eBaseline demographic and clinical characteristics and procedural details were prospectively gathered and available from the hospital database. In-hospital outcomes were prospectively collected in accordance with the standardized end-point definitions by the Mitral Valve Academic Research Consortium.\u003csup\u003e17\u003c/sup\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eImaging\u003c/h2\u003e \u003cp\u003ePatients underwent pre-procedural 2D TTE (GE Vivid E95, \u003cem\u003eGeneral Electric\u003c/em\u003e, Boston, Massachusetts, USA) and 2D TEE (GE Vivid E95) as required with an evaluation of: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) peak and mean transvalvular bioprosthetic gradients, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) peri- and transvalvular regurgitation, (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) left ventricular (LV) ejection fraction and (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) tricuspid annular plane systolic excursion (TAPSE). All had pre-procedural contrast-enhanced ECG-gated cardiac MSCT to assess: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) risk for iatrogenic LV outflow tract obstruction and (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) baseline SVH anatomy. The procedures were guided with 2D TEE (GE Vivid E95) with measurement of: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) residual peak and mean transvalvular gradient, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) peri- and transvalvular regurgitation, and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) gradient across the LV outflow tract. IVUS was performed at baseline (pre-procedural) and after successful THV deployment, with manual pullback parallel to the long axis of the SHV (baseline) or the THV (post-procedural). All MSCT images were recorded and available for \u003cem\u003eoffline\u003c/em\u003e analysis using syngo.via (Siemens Healthcare GmbH). Before discharge all patients underwent 2D TTE evaluations (GE Vivid E95A) with measured peak and mean transvalvular gradients and assessment of peri- and transvalvular regurgitation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eVolumetric IVUS and MSCT qualitative analysis\u003c/h2\u003e \u003cp\u003eUsing the double-oblique multiplanar reconstructions with the vertical oblique plane parallel with the failed bioprosthetic SHV long axis and the transverse plane oriented at the visualized perimeter of the bioprosthetic SHV ring, pre-procedural MSCT measurements included: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) minimal and maximal lumen IDs and cross-sectional areas and (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) inner stent (ring) minimal and maximal diameters and cross-sectional areas. Similarly, IVUS recordings were analyzed at the site of the SHV ring with the least image distortion (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe post-procedure MSCT was assessed by using a vertical oblique plane parallel to the THV long axis with a transverse plane oriented at the non-distorted THV stent frame perimeter. At 1mm steps along the entire THV height, measurements included inner and outer THV stent frame minimal and maximal diameters and cross-sectional areas. As a result, there were 18, 20, and 22 independent cross-sections for SAPIEN 3 THV 23mm, 26mm, and 29mm, respectively (Supplementary Fig.\u0026nbsp;1). We identified the IVUS loop with the best image quality after successful VIV deployment (not distorted) for THV stent frame visualization. Then we counted the total number of the following THV cross-sections recorded consistently within the known THV height; and within this number, we identified 18, 20, or 22 evenly spaced and non-distorted images that were measured the same way as MSCT images (Supplementary Fig.\u0026nbsp;2).\u003c/p\u003e \u003cp\u003eApplying Simpson\u0026rsquo;s Rule and using the measured outer stent frame dimensions (diameters and cross-sectional areas) from MSCT and IVUS studies, we calculated: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) average THV outer stent frame volume (cm\u003csup\u003e3\u003c/sup\u003e) and (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) minimal and maximal diameters (mm). These calculations were made per the entire THV height and independently per its inflow, mid (coaptation region), and outflow. The valve inflow height was equal to the outer skirt height (6.0mm, 7.0mm, and 8.1mm for 23mm, 26mm, and 29mm valves, respectively), and the valve mid height was considered as the difference between the corresponding outer and inner skirt heights (inner skirt heights: 9.3mm, 10.2mm, and 11.6mm for 23mm, 26mm, and 29mm valves, respectively). The THV outflow height was the overall stent frame height minus the inner skirt height.\u003csup\u003e18\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe average/minimal percentage (%) expansion of the THV stent frame in relation to nominal THV dimensions was calculated as the actually measured average/minimal outer sent frame volume/cross-sectional area divided by the corresponding nominal outer stent frame average volume/cross-sectional area x 100%. The nominal SAPIEN 3 THV outer stent frame cross-sectional area was derived from published studies that measured it with microCT after the valve expansion on air using the transfemoral Edwards Commander delivery system (Edwards Lifesciences) filled with a nominal volume of fluid.\u003csup\u003e19,20\u003c/sup\u003e The average % expansion was calculated for the entire THV height and separately for its inflow, mid, and outflow. Additionally calculated was % oversizing of the THV stent frame in relation to SHV (nominal THV outer stent frame area/SHV inner ring true area x 100% ̶ 100%).\u003csup\u003e16\u003c/sup\u003e THV eccentricity was calculated as max/min outer stent frame diameters.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eCategorical data are presented as numbers and frequencies and compared with the Pearson chi-square statistics. The one-sample Kolmogorov-Smirnov test was used to verify the distribution (normal vs nonuniform) of continuous parameters. Normally distributed variables were presented as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation and compared using the Paired-Samples T-test with computed Pearson correlation coefficients. Continuous variables with non-normal distributions presented are as medians with an interquartile range. Multivariate linear regression was used to search for independent correlates of (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) minimal THV inner stent frame area (measured using MSCT), (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) maximal transvalvular gradient measured pre-discharge, and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) the smallest minimal inner THV stent frame diameter measured using post-procedural MSCT, with computed parameter estimate and corresponding 95% confidence interval (Beta and 95%CI). Inter- and intra-observer variability in IVUS measurements were assessed with intraclass correlation coefficients. The reproducibility of the corresponding IVUS versus MSCT measurements was analyzed using the Bland-Altman plot analysis and calculated intraclass correlation coefficients. The limits of agreement were defined as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;1.96 SD of absolute difference. P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered significant. Statistical analysis was performed using the PASW Statistics 18 (IBM Corporation, Armonk, New York, USA).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e \u003cb\u003eDemographics and baseline clinical data\u003c/b\u003e. In the overall studied cohort (n\u0026thinsp;=\u0026thinsp;14) of consecutive patients treated with mitral/tricuspid VIV SAPIEN 3 THV implantation average age was 62.0\u0026thinsp;\u0026plusmn;\u0026thinsp;18.5 years, most were female (71.4%), and most (92.9%) were categorized as surgical high-risk; the degenerated bioprosthesis was mitral in 42.9% and tricuspid in 57.1% (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). In 50% of patients, the dominant bioprosthesis failure mode was mixed stenosis and regurgitation with nominal bioprosthesis size being \u0026ge;\u0026thinsp;29mm in 78.6%. Bioprostheses type distribution is shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline clinical, echocardiographic and MSCT characteristics.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll patients (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eDemographics and clinics\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e62.0\u0026thinsp;\u0026plusmn;\u0026thinsp;18.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (71.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBody mass index, kg/m\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27.1\u0026thinsp;\u0026plusmn;\u0026thinsp;5.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEuroSCORE II, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEuroSCORE II\u0026thinsp;\u0026gt;\u0026thinsp;4%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (92.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePermanent pacemaker, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (28.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAtrial fibrillation, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (71.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious myocardial infarction, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (14.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious percutaneous coronary intervention, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious coronary bypass surgery, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious stroke/TIA, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes mellitus, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (42.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (35.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDyslipidemia, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (35.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChronic renal disease, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (64.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChronic obstructive lung disease, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDysfunctional bioprosthesis\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDysfunctional bioprosthesis in mitral position\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (42.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDysfunctional bioprosthesis in tricuspid position\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (57.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStandard 3rd generation Carpentier-Edwards stented bovine valve\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (14.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCarpentier-Edwards PERIMOUNT Plus stented bovine valve\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCarpentier-Edwards PERIMOUNT Magna Ease stented bovine valve\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedtronic Mosaic bioprosthesis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (21.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedtronic Hancock II porcine bioprosthesis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (28.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSt Jude Medical Biocor valve\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (14.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAbbott Epic heart valve\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNominal outer bioprosthesis diameter 27 mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (21.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNominal outer bioprosthesis diameter 29 mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (28.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNominal outer bioprosthesis diameter 31 mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (50.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean nominal outer bioprosthesis diameter, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27.4\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean bioprosthesis stent true ID, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25.4\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration since surgical insertion, y\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.5 (9.0-19.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBaseline echocardiography\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransvalvular bioprosthetic gradient (peak), mmHg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20.5\u0026thinsp;\u0026plusmn;\u0026thinsp;7.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransvalvular bioprosthetic gradient (mean), mmHg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.1\u0026thinsp;\u0026plusmn;\u0026thinsp;9.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBioprosthetic dominant stenosis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (21.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBioprosthetic dominant regurgitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (28.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBioprosthetic mixed stenosis and regurgitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (50.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLV ejection fraction, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e55.1\u0026thinsp;\u0026plusmn;\u0026thinsp;10.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTAPSE, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12.9\u0026thinsp;\u0026plusmn;\u0026thinsp;3.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBaseline MSCT findings\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinimal bioprosthetic SHV stent ID, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26.3\u0026thinsp;\u0026plusmn;\u0026thinsp;1.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaximal bioprosthetic SHV stent ID, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27.5\u0026thinsp;\u0026plusmn;\u0026thinsp;1.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinimal lumen ID at the site of the bioprosthetic ring, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22.4\u0026thinsp;\u0026plusmn;\u0026thinsp;3.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaximal lumen ID at the site of the bioprosthetic ring, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23.6\u0026thinsp;\u0026plusmn;\u0026thinsp;3.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eProcedural data\u003c/b\u003e. There was significant correlation between SHV stent true ID and nominal THV diameter (r\u0026thinsp;=\u0026thinsp;0.865 and p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) with a nominal THV diameter that was oversized compared to the corresponding stent true ID (27.7\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9 vs 25.4\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1 mm, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). SAPIEN 3 THVs were mostly (64.3%) 29mm nominal size, with a nominal diameter that was \u0026gt;\u0026thinsp;2mm bigger than the corresponding SHV stent true ID and \u0026gt;\u0026thinsp;20% inner ring area oversizing in 6 patients (42.9%). SAPIEN 3 THV was deployed with nominal delivery balloon volume except three patients (21.4%) in whom operators at their own discretion overfilled it by 10%, mostly without preceding valvuloplasty (92.9%) and without post-dilation. Minor PVL and minor residual trans-valvular regurgitation were observed in 6 (42.9%) and 5 (35.7%) patients, respectively, with 3 (21.4%) having both. The in-hospital course of all patients was uneventful except for 1 extensive bleeding associated with vascular access requiring surgical intervention. In all patients, pre-discharge transvalvular gradients were bigger than peri-procedural measures with their maximal values of 14.9\u0026thinsp;\u0026plusmn;\u0026thinsp;3.7mmHg and 7.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.4mmHg, respectively (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eProcedural data.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll patients (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeneral anesthesia with intubation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (92.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConscious sedation and local anesthesia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransseptal access in TMVR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (100)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCerebral protection device (Sentinel)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSAPIEN 3 THV 23 mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSAPIEN 3 THV 26 mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (28.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSAPIEN 3 THV 29 mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (64.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNominal delivery balloon volume\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (57.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOverfilling delivery balloon volume\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (21.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePreceding valvuloplasty\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (7.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTrue inner SHV ring area oversizing, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19.7\u0026thinsp;\u0026plusmn;\u0026thinsp;10.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResidual peak transvalvular gradient, mmHg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6.7\u0026thinsp;\u0026plusmn;\u0026thinsp;1.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResidual mean transvalvular gradient, mmHg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinor paravalvular leak (trace/mild)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (42.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResidual transvalvular minor (trace/mild) regurgitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (35.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinor paravalvular and minor transvalvular leak/regurgitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (21.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eContrast agent volume, ml\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50 (22.5\u0026ndash;90.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFluoroscopy time, min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20.7 (17.2\u0026ndash;44.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRadiation, mGy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e767.0 (401.5-2081.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003e\u003csup\u003e*\u003c/sup\u003eusing an extra fluid\u0026thinsp;\u0026ge;\u0026thinsp;10% of the nominal inflation volume\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eBaseline MSCT and IVUS results.\u003c/b\u003e Minimal and maximal bioprosthetic SHV stent (ring) ID measured using baseline MSCT (n\u0026thinsp;=\u0026thinsp;14) were similar to the nominal (p\u0026thinsp;=\u0026thinsp;0.114 and p\u0026thinsp;=\u0026thinsp;0.864; respectively); whereas minimal and maximal lumen ID measured at the site of the bioprosthetic SHV ring were smaller than the corresponding stent true ID (p\u0026thinsp;=\u0026thinsp;0.005 and p\u0026thinsp;=\u0026thinsp;0.056; respectively). The nominal THV diameter was larger than the corresponding minimal and maximal lumen ID (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 for both), but was similar to the measured in baseline MSCT nominal and maximal bioprosthetic SHV stent ID (p\u0026thinsp;=\u0026thinsp;0.239 and p\u0026thinsp;=\u0026thinsp;0.774; respectively)(Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Baseline IVUS measurements (n\u0026thinsp;=\u0026thinsp;6) corresponded well with the respective MSCT dimensions (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of the corresponding results of IVUS and MSCT measurements, obtained at baseline at the site of failed SVH ring and after the VIV procedure at 1-mm step along the entire SAPIEN 3 THV height with assessed outer stent frame dimensions (the Paired-Samples T Test with computed Pearson correlation coefficients).\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIVUS\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMSCT\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ecorrelation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"5\" rowspan=\"6\"\u003e \u003cp\u003e\u003cb\u003ePlanar measurements at the site of failed SHV ring (n\u0026thinsp;=\u0026thinsp;6)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin lumen diameter, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.995\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMax lumen diameter, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22.2\u0026thinsp;\u0026plusmn;\u0026thinsp;3.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.985\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLumen area, cm\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.78\u0026thinsp;\u0026plusmn;\u0026thinsp;0.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.83\u0026thinsp;\u0026plusmn;\u0026thinsp;0.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.997\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStent minimal ID, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26.1\u0026thinsp;\u0026plusmn;\u0026thinsp;1.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.978\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.004\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStent maximal ID, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27.1\u0026thinsp;\u0026plusmn;\u0026thinsp;1.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e27.0\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.962\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.009\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStent inner area, cm\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.37\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5.39\u0026thinsp;\u0026plusmn;\u0026thinsp;0.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.998\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePost VIV THV replacement (immediately in IVUS and subsequently in MSCT)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e\u003cb\u003eEntire SAPIEN 3 THV height (n\u0026thinsp;=\u0026thinsp;6)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMinimal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.58\u0026thinsp;\u0026plusmn;\u0026thinsp;0.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.992\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMaximal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.79\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.73\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.992\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOuter frame stent volume, cm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.61\u0026thinsp;\u0026plusmn;\u0026thinsp;1.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5.57\u0026thinsp;\u0026plusmn;\u0026thinsp;1.08\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExpansion, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e91.9\u0026thinsp;\u0026plusmn;\u0026thinsp;11.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e91.2\u0026thinsp;\u0026plusmn;\u0026thinsp;11.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.998\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTHV eccentricity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.09\u0026thinsp;\u0026plusmn;\u0026thinsp;0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.676\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.141\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e\u003cb\u003eSAPIEN 3 THV inflow (n\u0026thinsp;=\u0026thinsp;6)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMinimal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.45\u0026thinsp;\u0026plusmn;\u0026thinsp;0.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.50\u0026thinsp;\u0026plusmn;\u0026thinsp;0.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.992\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMaximal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.72\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.64\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.976\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOuter frame stent volume, cm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.25\u0026thinsp;\u0026plusmn;\u0026thinsp;1.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5.20\u0026thinsp;\u0026plusmn;\u0026thinsp;1.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.998\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExpansion, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e86.2\u0026thinsp;\u0026plusmn;\u0026thinsp;11.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e85.2\u0026thinsp;\u0026plusmn;\u0026thinsp;11.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.997\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTHV eccentricity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.11\u0026thinsp;\u0026plusmn;\u0026thinsp;0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.05\u0026thinsp;\u0026plusmn;\u0026thinsp;0.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.626\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.184\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e\u003cb\u003eSAPIEN 3 THV mid segment (n\u0026thinsp;=\u0026thinsp;6)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMinimal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.48\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.46\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.965\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.002\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMaximal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.67\u0026thinsp;\u0026plusmn;\u0026thinsp;0.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.61\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.964\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.002\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOuter frame stent volume, cm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.11\u0026thinsp;\u0026plusmn;\u0026thinsp;1.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5.10\u0026thinsp;\u0026plusmn;\u0026thinsp;1.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.995\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExpansion, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e83.8\u0026thinsp;\u0026plusmn;\u0026thinsp;12.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e83.5\u0026thinsp;\u0026plusmn;\u0026thinsp;12.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.995\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTHV eccentricity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.08\u0026thinsp;\u0026plusmn;\u0026thinsp;0.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.020\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.969\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e\u003cb\u003eSAPIEN 3 THV outflow (n\u0026thinsp;=\u0026thinsp;6)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMinimal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.68\u0026thinsp;\u0026plusmn;\u0026thinsp;0.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.991\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMaximal diameter, cm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.90\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.84\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.990\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOuter frame stent volume, cm\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.04\u0026thinsp;\u0026plusmn;\u0026thinsp;1.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6.01\u0026thinsp;\u0026plusmn;\u0026thinsp;1.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.998\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExpansion, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e98.8\u0026thinsp;\u0026plusmn;\u0026thinsp;12.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e98.3\u0026thinsp;\u0026plusmn;\u0026thinsp;12.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.991\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTHV eccentricity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.09\u0026thinsp;\u0026plusmn;\u0026thinsp;0.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.736\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.096\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003ePost-procedural MSCT, peri-procedural IVUS, and pre-discharge TTE results\u003c/b\u003e. Overall, 190 THV cross-sections were analyzed in MSCT and 124 in IVUS. There was a good correlation between all the volumetric THV outer frame dimensions measured by IVUS versus MSCT (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The actual outer-frame expansion was smaller within the lengths of inflow and mid-THV height (overlapping the ring) than in the outflow, being substantially smaller than nominal (83.3\u0026thinsp;\u0026plusmn;\u0026thinsp;12.1% and 81.8\u0026thinsp;\u0026plusmn;\u0026thinsp;11.8% and 95.7\u0026thinsp;\u0026plusmn;\u0026thinsp;12.1% in MSCT versus 85.9\u0026thinsp;\u0026plusmn;\u0026thinsp;11.3% and 83.8\u0026thinsp;\u0026plusmn;\u0026thinsp;11.8% and 98.8\u0026thinsp;\u0026plusmn;\u0026thinsp;12.7% in IVUS; respectively, Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). There were high inter- and intra-observer agreement in IVUS measurements (Supplementary Table\u0026nbsp;1). Comparing 248 corresponding pairs of inner and outer-stent frame THV cross-sectional measurements (minimal and maximal diameters and cross-sectional areas) made using IVUS and MSCT, there was a good agreement (intraclass correlation coefficient from 0.990 to 0.999, Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e, Supplementary Table\u0026nbsp;2).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe minimal percentage of THV expansion measured using MSCT and IVUS were 80.1\u0026thinsp;\u0026plusmn;\u0026thinsp;10.0% and 79.0\u0026thinsp;\u0026plusmn;\u0026thinsp;11.1%, respectively, with corresponding minimal inner SAPIEN 3 THV frame area of 3.47\u0026thinsp;\u0026plusmn;\u0026thinsp;0.78cm\u003csup\u003e2\u003c/sup\u003e and 3.22\u0026thinsp;\u0026plusmn;\u0026thinsp;0.62cm\u003csup\u003e2\u003c/sup\u003e. The degree of the % THV oversizing in relation to SHV correlated inversely with a minimal % THV expansion in relation to nominal size measured in both IVUS and MSCT (r=-0.876, p\u0026thinsp;=\u0026thinsp;0.002 and r=-0.86, p\u0026thinsp;=\u0026thinsp;0.026; respectively); but minimal inner THV stent frame area was independently predicted only by stent true ID (Beta\u0026thinsp;=\u0026thinsp;0.313, 95%CI\u0026thinsp;=\u0026thinsp;0.183\u0026ndash;0.442, r\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;0.823, p\u0026thinsp;=\u0026thinsp;0.001). The only independent predictor of the maximal transvalvular gradient measured pre-discharge was the smallest minimal inner THV frame diameter (r\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;0.67, Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e), which was predicted by the true bioprosthetic SHV stent ID (Beta\u0026thinsp;=\u0026thinsp;0.066, 95%CI\u0026thinsp;=\u0026thinsp;0.015\u0026ndash;0.117, r\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;0.49, p\u0026thinsp;=\u0026thinsp;0.037).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCorrelates of maximal transvalvular gradient measured pre-discharge.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026minus;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eUnivariate\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e \u003cp\u003eMultivariable\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBeta\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95%CI\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBeta\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e95%CI\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTrue stent ID (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e-1.062\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e-1.928 ̶ -0.195\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.020\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNominal SAPIEN 3 THV diameter (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-0.873\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-1.932 ̶ 0.186\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.098\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinimal lumen diameter measured in baseline MSCT at the site of bioprosthetic SVH ring (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-0.126\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-0.735 ̶ 0.486\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.694\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e% SAPIEN 3 THV outer stent frame area oversizing (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.153\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-0.052 ̶ 0.359\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.130\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinimal % expansion of SAPIEN 3 THV outer frame in MSCT (n\u0026thinsp;=\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-2.693\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-24.776 ̶ 19.390\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.818\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinimal inner SAPIEN 3 THV stent frame area (n\u0026thinsp;=\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e-2.766\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e-5.179 ̶ -0.353\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.030\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e-\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe smallest minimal inner SAPIEN 3 THV stent frame diameter measured in post-procedural MSCT (n\u0026thinsp;=\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e-11.495\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e-18.783 ̶ -4.207\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.007\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e\u0026minus;\u0026thinsp;11.495\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e-18.783 ̶ -4.207\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.007\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOptimal THV leaflet function requires the stent frame to be fully expanded (100% nominal) and circular.\u003csup\u003e7,21,22\u003c/sup\u003e Peri-procedural angiographic guidance of THV stent frame expansion, including rotational 3D angiography,\u003csup\u003e15\u003c/sup\u003e has limitations due to visual resolution and projection angles (the short axis of the valve is often unattainable with fluoroscopy). TEE visual resolution is also limited; it is used less and less (\"minimalist THV deployment\") and is hampered by acoustic shadows and poor imaging windows. Peri-procedural Doppler measurements, including those with TEE, are often biased, with subsequent values frequently higher.\u003csup\u003e23\u003c/sup\u003e With this background, the current study is the first to use IVUS to assess actual SAPIEN 3 THV stent frame expansion immediately following successful TMVR or TTVR VIV. The major findings of the current study are as follows. (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) Expansion was significantly smaller than nominal, especially where it overlaps with the bioprosthetic SHV ring. (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) IVUS findings were comparable to the current gold standard MSCT assessment. (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) Minimal inner SAPIEN 3 THV stent frame dimensions correlated directly with increased transvalvular gradients recorded pre-discharge. For example, other authors using MSCT studies of early dysfunctional THVs (less than one year since deployment) found stent frame under-expansion in the THV inflow and midportion that was corrected with subsequent dilatations using a non-compliant tubular balloon with a diameter equal to the nominal THV size.\u003csup\u003e24\u003c/sup\u003e This could have been prevented with intraprocedural IVUS guidance.\u003c/p\u003e \u003cp\u003eIn a previous pig model, the authors inserted 26mm SAPIEN 3 THVs into stented bioprosthetic SHVs with varying inner diameters following the VIV Mitral app\u0026rsquo;s recommendation of a nominal THV diameter 2mm larger than the SHV inner diameter.\u003csup\u003e25,26\u003c/sup\u003e Despite our study having a smaller THV oversizing percentage than the pig model, the actual inflow and outflow expansion percentages were larger. This underscores the importance of peri-procedural insights into the actual results over the pre-procedural planning. In an in vitro analysis of mitral hemodynamic performance after VIV deployment of first-generation SAPIEN THV into brand-new surgical bioprostheses, the authors found that VIV deployment was associated with increased transvalvular gradients, particularly in bioprostheses with small stent true ID and higher % oversizing, aligning with the VIVID Registry findings.\u003csup\u003e27,28\u003c/sup\u003e In the current analysis, only the bioprosthesis stent true ID remained an independent correlate of minimal inner SAPIEN 3 THV stent frame dimension. Although maximal transvalvular gradients measured pre-discharge in the current study were bigger for smaller bioprostheses, it was the measured minimal inner SAPIEN 3 THV stent frame diameter that independently explained 67% of its variability.\u003c/p\u003e \u003cp\u003eThe current results suggest that in the lifelong management of transcatheter heart valve replacements, including aortic procedures with a significant readmissions rate, accurate peri-procedural insights using IVUS hold great potential for guiding the process, both at the initial and redo levels). This complements detailed pre-procedural planning using baseline MSCT and bench tests results.\u003csup\u003e29\u0026ndash;32\u003c/sup\u003e Potential for improved procedural outcomes may justify the cost of incorporating IVUS equipment. Its integration into THV procedures may add to the overall procedural time, and it would be essential to weigh the benefits of real-time guidance and precise measurements against delays.\u003c/p\u003e \u003cp\u003e \u003cb\u003eStudy Limitations.\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThis is a proof-of-concept study of a small number of patients. Two patients were excluded due to high residual gradients measured during the procedure, but we couldn\u0026rsquo;t evaluate the expansion of their stent frames because we didn\u0026rsquo;t do IVUS or MSCT. We expect that a future multi-center investigator-initiated research will provide a more thorough analysis of our findings. The accuracy of our results might be influenced by the non-coaxial IVUS transducer location. Significant errors can occur when the transducer is angled more than 25 degrees off-center, but this can be corrected with gentle wire adjustments (e.g. right ventricle loop or pulmonary artery wire position during TTVR VIV) and use of steerable sheaths.\u003csup\u003e33\u003c/sup\u003e Technological advancements should automate IVUS pullback and reduce variability caused by the transducer location. The Edwards Commander Delivery system comes with a compliant balloon. If this balloon is inflated at the rigid ring with a substantially smaller inner dimension, it may unevenly distribute the inflation fluid toward areas with less resistance, affecting the actual stent frame expansion. Overfilling the balloon can enhance this issue. We didn\u0026rsquo;t adjust nominal SAPIEN 3 THV dimensions to account for this overfilling.\u003csup\u003e19\u003c/sup\u003e Importantly, none of the valves was cracked/remodeled, but IVUS seems to be a helpful for guiding these, even for non-aortic valves.\u003csup\u003e34\u003c/sup\u003e\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003ePeri-procedural use of a large field-of-view IVUS offers accurate and \u003cem\u003eonline\u003c/em\u003e measurements of actual expansion of SAPIEN 3 THVs deployed for valve-in-valve enabling clinicians to make real-time, data-driven decisions to enhance outcomes. Measured minimal inner THV stent frame dimensions correspond with increased post-procedural transvalvular gradients and post-dilatation of the stent frame might be justified in such cases.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eID = inner diameter\u003c/p\u003e\n\u003cp\u003eIVUS = intravascular ultrasound\u003c/p\u003e\n\u003cp\u003eLV = left ventricular \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMSCT = multi-slice computer tomography\u003c/p\u003e\n\u003cp\u003ePVL = paravalvular leak\u003c/p\u003e\n\u003cp\u003eSHV = surgical heart valve\u003c/p\u003e\n\u003cp\u003eTEE = transoesophageal echocardiography\u003c/p\u003e\n\u003cp\u003eTHV = transcatheter heart valve\u003c/p\u003e\n\u003cp\u003eTMVR = transcatheter mitral valve replacement\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTTE = transthoracic echocardiography\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTTVR = transcatheter tricuspid valve replacement\u003c/p\u003e\n\u003cp\u003eVIV = valve-in-valve\u003cstrong\u003e\u003cbr\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAll authors reviewed the manuscriptŁukasz Kalińczuk and Marcin Demkow performed the procedureWiktor Skotarczak, Karol A Sadowski, Patrycjusz Stokołosa, Sara Kochańska - wrote the main manuscript textMaciej Dąbrowski, Olgierd Woźniak - prepared figuresAgata Kubik, Ilona Kowalik - patient qualificationAdam Witkowski, Ilona Michałowska - prepared tablesGary S Mintz, Lars Sondergaard - senio author\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor disclosures:\u003c/strong\u003e Authors did not report conflicts of interest related to the presented study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eWhisenant B, Kapadia SR, Eleid MF, Kodali SK, McCabe JM, Krishnaswamy A, Morse M, Smalling RW, Reisman M, Mack M, O\u0026apos;Neill WW, Bapat VN, Leon MB, Rihal CS, Makkar RR, Guerrero M. 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Valve-in-valve transcatheter aortic valve implantation versus repeat surgical aortic valve replacement in patients with a failed aortic bioprosthesis. EuroIntervention. 2022;17:1227-1237.\u003c/li\u003e\n \u003cli\u003eGeselschap JH, Heilbron MJ, Hussain FM, Daskalakis TM, Wilson EP, Kopchok GE, White RA. The effect of angulation on intravascular ultrasound imaging observed in vascular phantoms. J Endovasc Surg. 1998;5:126-133.\u003c/li\u003e\n \u003cli\u003eKrishnaswamy A, Kaur S, Isogai T, Zhou L, Shekhar S, Yun J, Unai S, Burns D, Kapadia S. Minimalist Mitral Valve-in-Valve Replacement Using Conscious Sedation and Intracardiac Echocardiography Is Feasible and Safe. JACC Cardiovasc Interv. 2022;15:1288-1290.\u003cstrong\u003e\u003c/strong\u003e\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"transcatheter valve implantation, valve-in-valve procedure, TMVR, TTVR","lastPublishedDoi":"10.21203/rs.3.rs-3873842/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3873842/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e. Actual expansion of a transcatheter heart valve (THV) might differ from nominal particularly during non-aortic valve-in-valve (VIV) for degenerated bioprosthetic surgical heart valve (SHV).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAims. \u003c/strong\u003eTo compare THV expansion measured using large-field-of-view intravascular ultrasound (IVUS) versus multi-slice computer tomography (MSCT) and assess the correlation between THV dimensions and transvalvular gradients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods. \u003c/strong\u003eFourteen patients were successfully treated with mitral/tricuspid VIV SAPIEN 3 implantation sized using the true SHV inner diameter; all 14 had baseline MSCT and transvalvular gradients measured at baseline, post-procedure, and at discharge. Peri-procedural IVUS (in 6 patients using with a Philips 10MHz Vision PV035) was compared with post-procedural MSCT (in 9 patients) with offline measurements performed at 1-mm steps along the THV height, and analyzed 190 MSCT and paired 124 IVUS cross-sections.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults. \u003c/strong\u003eThere was very good agreement between IVUS THV dimensions and corresponding MSCT measurements (intraclass correlation coefficient ≥0.986 and p\u0026lt;0.001). IVUS measured THV expansion (percent of the nominal cross-sectional area) was smaller within the inflow and middle of the THV overlapping the ring (85.9±11.3%, 83.8±11.8%) than within the outflow (98.8±12.7%). The residual mean transvalvular gradient increased from peri-procedural to pre-discharge (3.5±2.0 vs 6.3±1.7mmHg, p\u0026lt;0.001). The only independent predictor of pre-discharge maximal transvalvular gradient was the smallest minimal inner THV frame diameter (r\u003csup\u003e2\u003c/sup\u003e=0.67), predicted by true SHV internal diameter (Beta = 0.066, 95%CI = 0.015 – 0.117, r\u003csup\u003e2\u003c/sup\u003e=0.49, p=0.037).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions. \u003c/strong\u003ePeri-procedural use of a large field-of-view IVUS offers accurate insight into actual THV expansion when deployed valve-in-valve. Minimal inner THV stent frame dimensions correlate with increased post-procedural transvalvular gradients.\u003c/p\u003e","manuscriptTitle":"Large field-of-view intravascular ultrasound for actual valve-in-valve transcatheter heart valve expansion. A Pilot study. 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