Efficacy and Safety of Emergent Balloon Aortic Valvuloplasty as a Rescue Therapy for Cardiogenic Shock Due to Severe Aortic Stenosis in Non-TAVI Centers

Efficacy and Safety of Emergent Balloon Aortic Valvuloplasty as a Rescue Therapy for Cardiogenic Shock Due to Severe Aortic Stenosis in Non-TAVI Centers | 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 Efficacy and Safety of Emergent Balloon Aortic Valvuloplasty as a Rescue Therapy for Cardiogenic Shock Due to Severe Aortic Stenosis in Non-TAVI Centers Mayuka Masuda, Wataru Fujimoto, Masamichi Iwasaki, Kenzo Uzu, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5993165/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 25 Nov, 2025 Read the published version in BMC Cardiovascular Disorders → Version 1 posted 21 You are reading this latest preprint version Abstract Background The prognosis of aortic stenosis (AS) with cardiogenic shock remains poor, and optimal initial treatment remains unclear. Emergent balloon aortic valvuloplasty (BAV) is a treatment option for salvage and recent studies have reported that early release of valve obstruction by emergent BAV could improve prognosis. This study aimed to assess the efficacy and safety of emergent BAV for severe AS with cardiogenic shock. Methods A total of 41 patients with severe AS in cardiogenic shock were enrolled and divided into the emergent (underwent BAV within 12h of admission, n = 10) and non-emergent (underwent BAV more than 12h after admission, n = 15) groups, after excluding 16 patients who did not undergo BAV. The primary endpoints were the 30-day mortality rate and procedural complications. The secondary endpoints were days to withdrawal from the mechanical circulatory support (MCS), days to initial rehabilitation, and clinical frailty scale (CFS) score at discharge. Results The 30-day mortality rate was not significantly different between the emergent and non-emergent groups (10% vs. 20%, p = 0.63). One patient experienced stroke after procedure in the non-emergent group. The days to withdrawal from MCS and to start rehabilitation were earlier in emergent group (2.9 ± 1.2 days vs. 7.8 ± 4.6 days; p < 0.01, 4.2 ± 1.9 days vs. 10.8 ± 6.5 days; p < 0.01). The CFS score at discharge in the emergent group was maintained compared to before admission (from 3.8 ± 1.0 to 3.9 ± 1.1; p = 0.35), whereas worsened in the non-emergent group (from 3.8 ± 0.9 to 4.6 ± 1.2; p = 0.03). Conclusions Emergent BAV for cardiogenic shock is feasible, and earlier BAV would provide immediate recovery and prevent deterioration of frailty. aortic stenosis balloon aortic valvuloplasty cardiogenic shock retrospective study Figures Figure 1 Figure 2 Figure 3 INTRODUCTION The incidence of acute decompensated heart failure (ADHF) due to severe aortic stenosis (AS) has been increasing in the aging population [ 1 , 2 ]. In particular, the prognosis of patients with AS who present with cardiogenic shock remains poor [ 3 , 4 ], and the optimal initial treatment remains unclear. Surgical aortic valve replacement (SAVR), the conventional definitive therapy for AS, is associated with a worse prognosis in patients with ADHF or cardiogenic shock than in hemodynamically stable patients [ 3 , 4 ]. Although transcatheter aortic valve implantation (TAVI) has been introduced as another therapeutic option for patients at high surgical risk, previous reports have revealed that the rates of procedural complications and 30-day mortality increased fivefold in emergent TAVI for patients with cardiogenic shock compared to that in elective cases [ 5 ]. In addition, not all facilities in Japan can perform TAVI, even those specializing in cardiovascular disease. Emergent balloon aortic valvuloplasty (BAV) is a treatment option for salvaging patients with cardiogenic shock due to severe AS [ 6 ]. In comparison to TAVI, BAV is less scrutinized and more cost-effective. As a temporary procedure, it is suitable for hemodynamically unstable patients in emergency situations. Recent studies have reported that immediate release of aortic valve obstruction by emergent BAV could improve prognosis, whereas delayed BAV is considered to be directly related to dire outcomes [ 7 , 8 ]. This study aimed to assess the efficacy and safety of emergent BAV as a rescue therapy for cardiogenic shock due to severe AS. METHODS Study design and patient population This multicenter retrospective study conducted in six non-TAVI centers (Hyogo Prefectural Awaji Medical Center, Konan Medical Center, National Hospital Organization Kobe Medical Center, Osaka Saiseikai Nakatsu Hospital, Yodogawa Christian Hospital, and Ako City Hospital) included patients hospitalized for cardiogenic shock due to severe AS between January 2015 and July 2022. Cardiogenic shock was defined as the combination of 1) administration of catecholamines, including dobutamine and milrinone, insertion of intra-aortic balloon pump (IABP), or low cardiac index (less than 2.2 L/min/m 2 ) and 2) systemic hypoperfusion identified by the combination of several parameters including altered mental status (Glasgow Coma Scale score < 15), cold/clammy skin and extremities, oliguria with urine output of less than 30 mL/h, serum lactate level higher than 2.0 mmol/L (18 mg/dL), or systolic blood pressure less than 90 mmHg. The following shock statuses related to causes other than severe AS were excluded from this study: acute coronary syndrome, tamponade, stress cardiomyopathy, pulmonary embolism, myocarditis, severe aortic regurgitation, severe mitral regurgitation/stenosis, or concomitant sepsis or severe bleeding. Furthermore, despite of presenting with cardiogenic shock due to severe aortic stenosis patients who did not wish invasive treatment due to their advanced age, frailty, or comorbidities, were excluded. Participants were divided into two groups. The emergent group included patients who underwent BAV within 12 h of admission, and the non-emergent group included patients who underwent BAV more than 12 h after admission. Clinical information, including baseline patient characteristics, procedural details, and clinical outcomes, was carefully reviewed using the electronic medical records from each hospital. This study was approved by the ethics committees of all six facilities, performed according to the guidelines of the Declaration of Helsinki, and registered in the UMIN Clinical Trial Registry (UMIN 000054925) on July 10th, 2024. BAV procedures All BAV procedures were performed under local anesthesia following the Japanese standards using a retrograde or antegrade approach at the discretion of each operator [ 9 , 10 ]. In the retrograde arterial approach, balloon catheters were delivered through a 7–10-Fr sheath via the radial, brachial, or femoral artery. The antegrade transseptal approach was performed using a 12–14-Fr sheath via the femoral vein. In every case, we attempted to use a right heart catheter before and after BAV to evaluate the hemodynamic changes both pre- and post-BAV. During the procedure, intracardiac or transthoracic echocardiography was performed to assess whether the aortic valve was properly dilated or if the aortic regurgitation had worsened (Supplemental Table 1). Study endpoints The primary endpoints were the 30-day mortality rates and procedural complications, which were described according to the Valve Academic Research Consortium-3 (VARC-3) criteria [ 11 ]. The secondary endpoints were days to withdrawal from the mechanical support device, days to initial rehabilitation, and clinical frailty scale (CFS) score on discharge. These endpoints were calculated from the date of admission. The start of rehabilitation was defined as the time when the patient started sitting in the wheelchair. Statistical analysis All data are presented as mean ± standard deviation for continuous variables and as frequencies (percentages) for discrete variables. Continuous variables were analyzed using Student’s t-test and the Mann–Whitney U test according to a normal or non-normal distribution, respectively. The chi-square or Fisher’s exact test was performed to compare the proportions of categorical variables. Statistical significance was set at p < 0.05. Analyses were performed using the commercially available SPSS software (version 29; SPSS Inc., Chicago, IL, USA). Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research. RESULTS Baseline patient characteristics Among 8230 patients who were hospitalized for heart failure between January 2015 and July 2022, a total of 41 patients with cardiogenic shock due to severe AS were enrolled and divided into the emergent (n = 10, 20.0% male, mean age 85.7 ± 6.7 years) and non-emergent (n = 15, 46.7% male, mean age 89.3 ± 5.6 years) groups (Fig. 1 ). Sixteen patients (No-BAV patients) who did not undergo BAV during their hospitalization were excluded from the study (Supplemental table 2 ). The baseline characteristics showed no remarkable differences in comorbidities or the CFS score. The Society of Thoracic Surgeons (STS) score and IABP use were significantly higher in the emergent group. Additionally, in the emergent group, BAV was performed as soon as the diagnosis of cardiogenic shock due to severe AS was made; the time from admission to BAV was 3.5 ± 2.1 h. In the non-emergent group, BAV was performed 5 days (median) after admission (Table 1 ). Procedural data Procedural data pre- and post-BAV revealed a significant reduction in the mean transaortic gradient (from 67.2 ± 26.1 mmHg to 37.4 ± 16.6 mmHg; p = 0.02, in the emergent group, and from 63.1 ± 25.6 mmHg to 32.0 ± 16.1 mmHg; p < 0.01 in the non-emergent group) and an increase in the aortic valve area (from 0.4 ± 0.2 cm 2 to 0.7 ± 0.2 cm 2 ; p = 0.01, and from 0.5 ± 0.2 cm 2 to 0.8 ± 0.3 cm 2 ; p = 0.02, respectively) (Table 2 ). Table 2 Hemodynamic parameter of pre- and post- BAV Pre BAV Post BAV p value Emergent group Mean pressure gradient (mmHg) 67.2 ± 26.1 37.4 ± 16.6 0.02 AVA (cm 2 ) 0.4 ± 0.2 0.7 ± 0.2 0.02 CI (L/min/m 2 ) 2.6 ± 0.7 3.0 ± 0.5 0.25 PCWP (mmHg) 23.7 ± 16.1 18.0 ± 7.2 0.37 Non-emergent group Mean pressure gradient (mmHg) 63.1 ± 25.6 32.0 ± 16.1 < 0.01 AVA (cm 2 ) 0.5 ± 0.2 0.8 ± 0.3 0.02 CI (L/min/m 2 ) 2.5 ± 0.7 2.7 ± 0.6 0.44 PCWP (mmHg) 17.0 ± 9.9 13.6 ± 6.8 0.35 Quantitative data are shown as means ± standard deviations. AVA: aortic valve area; CI: cardiac index; PCWP: pulmonary capillary wedge pressure. Thirty-day mortality and procedural complications The 30-day mortality rate was not significantly different between the two groups (emergent group, n = 1 [10%]; non-emergent group, n = 3 [20%]; p = 0.63). One patient in the emergent group died of alveolar hemorrhage, and three patients in the non-emergent group died of heart failure (n = 2) and cardiogenic shock (n = 1). No vascular or access-related complications were observed. One patient experienced stroke on the day after the procedure in the non-emergent group. The percentage of patients who were either ambulatory upon discharge or walking on their own was 50% (n = 5) in the emergent group and 33.3% (n = 5) in the non-emergent group (p = 0.41) (Table 3 ). Table 3 Clinical outcomes Variables Emergent (n = 10) Non-emergent (n = 15) p value 30-day mortality, n (%) 1 (10) 3 (20.0) 0.63 -Cardiac death, n (%) 0 (0) 2 (13.3) -Non cardiac death, n (%) 1 (10) 1 (6.7) Procedural complication, n (%) 1 (10) 1 (6.7) 0.76 -Neurologic events, n (%) 0 (0) 1 (6.7) -Myocardial infarction, n (%) 0 (0) 0 (0) -Acute kidney injury, n (%) 0 (0) 0 (0) -New dialysis, among patients not currently on dialysis, n (%) 0 (0) 0 (0) -Bleeding and transfusions, n (%) 1 (10) 0 (0) -Vascular and access-related complications, n (%) 0 (0) 0 (0) -New conduction disturbance and arrhythmias, n (%) 0 (0) 0 (0) -Post-procedural AR grade ≥ 3, n (%) 0 (0) 0 (0) Qualitative data are presented with frequencies. Days to withdrawal from mechanical support and to initial rehabilitation The days to withdrawal from mechanical support, including IABP, ventilator, and non-invasive positive pressure ventilation were 2.9 ± 1.2 days in the emergent group and 7.8 ± 4.6 days in the non-emergent group (p < 0.01). Moreover, the days to start rehabilitation in the two groups were 4.2 ± 1.9 days and 10.8 ± 6.5 days, respectively (p < 0.01) (Fig. 2 ). Comparison of the CFS score before admission and at discharge Comparing values before admission to values at discharge, the CFS score was maintained in the emergent group (from 3.8 ± 1.0 to 3.9 ± 1.1; p = 0.35) but significantly worsened in the non-emergent group (from 3.8 ± 0.9 to 4.6 ± 1.2; p = 0.03) (Fig. 3 ). DISCUSSION The current study revealed that (1) the 30-day mortality rate for patients with severe AS with cardiogenic shock undergoing BAV was 10% in the emergent group and 20% in the non-emergent group; (2) no intraprocedural complications were observed in this study population; (3) the emergent group required less than half the days of weaning from the ventilator and high-care units than those required by the non-emergent group; and (4) frailty did not progress in the emergent group. Current role of BAV BAV was introduced as a therapeutic option by Cribier et al. in 1986 [ 12 ]. The initial reduction in the pressure gradient during the procedure was favorable; however, it did not improve the mid-term prognosis because of the high early restenosis rate. Therefore, the use of BAV decreased dramatically with the advent of TAVI in 2002. Nonetheless, BAV has recently been highlighted as a rescue therapy for hemodynamically unstable patients, even in the TAVI era [ 13 ]. Current national registries in Europe and the United States have disclosed an increase in BAV cases [ 13 , 14 ], of which BAV for salvage accounts for approximately 10% of cases [ 13 , 15 ]. This phenomenon could be explained by the fact that the number of cases of cardiogenic shock due to severe AS for which direct AVR is not possible has increased, and emergent BAV is performed in the real world as a salvage therapy. Outcomes of emergent BAV in patients with cardiogenic shock In 2018, Debry et al. assessed the outcomes of BAV as a rescue therapy in patients with cardiogenic shock due to severe AS and revealed that the 30-day mortality rate was 47% [ 8 ]. Eugene et al. also reported that the rate of early death was 30% for cardiogenic shock or refractory pulmonary edema [ 16 ]. These previous reports have again depicted the poor prognosis of patients with cardiogenic shock due to severe AS; however, they also suggest that early intervention toward aortic valve obstruction will improve prognosis. Early direct intervention (within 48 h) for aortic valve obstruction can help prevent the need for high doses of catecholamines, which would decrease the risk of multi-organ failure [ 8 ]. In this study, although not statistically significant, the 30-day mortality rate in the emergent group (10%) was half of that in the non-emergent group (20%). There is no evidence to determine how quickly treatment should be administered to be effective, but it was revealed that the sooner pulmonary edema is relieved, the better the prognosis [ 17 ]. This may explain why the emergent group, treated approximately 3.5 ± 2.1 h after admission, had better outcomes than those of patients in the non-emergent group and previously reported cases of AS with cardiogenic shock. Therefore, reducing the duration of cardiogenic shock until the release of valve obstruction is the key to salvaging patients in the acute phase. We also revealed that immediate BAV can promote withdrawal from mechanical support, facilitate rehabilitation, and prevent the deterioration of the CFS score. Being bedridden for a long duration has been known to lead to a reduction in muscle strength by 1% per day, even for a healthy adult [ 18 ]; therefore, it is important to shorten the duration in which older patients are bedridden as much as possible due to their already reduced muscle strength [ 19 ]. Moreover, the CFS score at discharge affects the prognosis of patients with heart failure [ 20 ]. When it comes to bridging TAVI, the preprocedural CFS score is reported to be an independent prognostic factor after undergoing TAVI [ 21 ]; thus, maintaining the CFS score in older patients during hospitalization is an inevitable issue for clinicians. Therefore, our findings that emergent BAV may contribute to preventing worsening frailty and promoting a smooth bridge to subsequent definitive therapy support the potential advantages of BAV for critically ill older patients. Comparison of safety between emergent and non-emergent BAV Emergent procedures for hemodynamically unstable patients are high-pressure situations for operators and are generally thought to increase the risk of intraprocedural complications; however, our study showed no significant difference in periprocedural complication rates. Previous reports have also shown lower intraprocedural complication rates in emergent BAV than in emergent TAVI [ 22 ]. While the treatment targets severe cases with poor prognosis, performing BAV in an emergency setting was not considered to be directly related to adverse events. Additionally, all institutions included in this study were primary hospitals in their respective regions but did not have approval to perform TAVI. As for BAV, a volume-outcome relationship was not observed in the nationwide registry data in Japan [ 10 ]. BAV may be advantageous in emergency situations as an easy-to-use procedure. Emergent TAVI TAVI is another therapeutic option for severe AS with cardiogenic shock. Since its introduction in 2002, TAVI use has been increasing rapidly worldwide as a counterpart to SAVR in patients at high surgical risk. Recently, the indications for TAVI have been expanding towards critically ill patients, and the question about the potential use of emergent TAVI in the management of patients with cardiogenic shock currently remains open. Frerker et al. reported a 30-day mortality rate of 33.3% in emergent TAVI for cardiogenic shock, which was significantly higher than that in electively treated patients (7.7%; p < 0.0001). Moreover, there were no significant differences in the rates of major or minor vascular complications; however, patients with cardiogenic shock developed acute kidney injury significantly more often (29.8% vs. 5.0%, p < 0.001) [ 23 ]. In 2020, The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy registry revealed that emergent TAVI for cardiogenic shock was associated with higher 30-day mortality (19.1% vs. 4.9%, p < 0.001) and complication rates compared to those in a high-risk cohort that did not present with cardiogenic shock [ 5 ]. Thus, to date, emergent TAVI has been reported to have significantly poorer outcomes compared to those for elective cases. However, previous reports have concluded that emergency TAVI appears to be a viable option for patients with cardiogenic shock, considering the originally poor prognosis of patients with AS presenting with cardiogenic shock. Emergent BAV and TAVI Very few studies have directly compared emergent BAV and TAVI in patients with cardiogenic shock. In 2018, Bongiovannni et al. assessed the early outcomes of emergent TAVI versus emergent BAV followed by elective TAVI in a multicenter cohort. Immediate procedural mortality rate was 8.7% in the emergent TAVI group compared with 20.3% in the emergent BAV group (p = 0.19), and rates of cardiovascular mortality after 30 days were comparable in the emergent TAVI and BAV groups (23.8% vs. 33.0%, p = 0.40). Significant major vascular complications have been observed after emergent TAVI (p = 0.01) and stroke (p = 0.01) [ 24 ]. The latest study evaluating the impact of emergent BAV or TAVI on outcomes in patients with cardiogenic shock revealed that BAV was associated with a short-term mortality benefit, including statistically similar in-hospital mortality rates to those for TAVR and surgical AVR [ 21 ]. These studies uniformly noted that emergent BAV and TAVI are feasible and associated with acceptable outcomes in the acute phase for patients with cardiogenic shock; however, it was also noted that BAV would yield temporal stabilization of patients with cardiogenic shock, and the mortality rate would increase if patients were not offered definitive therapy. Emergent TAVI has several limitations. First, the device size may make its use challenging. In emergency situations, the aortic annulus can only be appropriately measured using echocardiography and not multidetector computed tomography (MDCT), which is the current standard for elective situations. The most common post-procedural complication is paravalvular leakage (PVL), and even mild PVL is associated with increased late mortality [ 25 ]. Compared to MDCT, two-dimensional transesophageal echocardiography is associated with a significantly lower incidence of more than moderate PVL after TAVI [ 25 ]. Therefore, performing TAVI without this information may increase the procedural risks. Second, TAVI or emergent TAVI is not available at all hospital sites, and patients with cardiogenic shock cannot be transferred to qualified centers in hemodynamically unstable situations. BAV is simple, less scrutinized, and does not necessarily require MDCT information before the procedure. Therefore, emergent BAV is superior to TAVI, and emergent BAV may also be a therapeutic option in facilities offering TAVI. The benefit of emergent BAV lies in its temporary therapeutic effect. First, emergent BAV may be an especially useful strategy if the cause of cardiogenic shock is uncertain or for patients with mixed shock due to bleeding, sepsis, or active infection. Definitive therapies should be offered if patients respond favorably and if severe AS has been proven to be the cause of cardiogenic shock. Second, BAV may allow for a better selection of patients who would benefit from definitive therapies after clinical and hemodynamic stabilization. In the acute phase, it may be challenging to ascertain whether patients with shock are optimal candidates for definitive therapies, including TAVI or SAVR, in terms of frailty, comorbidities, and life expectancy. Limitations The results of our study should be interpreted in the context of some limitations. First, the candidates in our study were limited to patients with cardiogenic shock; therefore, the sample size was small, despite it being a multicenter retrospective study. Second, there was a lack of uniformity in the BAV technique, including the selection of the balloon type and size. Third, considering the methodological limitations of the retrospective design, the effects of potential selection bias and unmeasured covariates cannot be excluded. Sixteen patients did not undergo BAV, primarily due to the wishes of the patients and their families. However, various factors remain unclear, such as the timing of the decision or admission, the conditions of each hospital, and the perspectives of the medical staff. Finally, cardiogenic shock was diagnosed retrospectively using electronic medical records, which may have led to the underreporting of cases in which the diagnosis was not accurately recorded. CONCLUSION Emergent BAV for cardiogenic shock is a feasible and effective rescue therapy, and earlier BAV is suggested to bring about immediate recovery, prevent frailty, and provide a smooth bridge to subsequent treatment in cardiogenic shock patients due to severe AS. Declarations Ethics approval: This study was approved by the ethics committees of all six facilities and performed according to the guidelines of the Declaration of Helsinki. Patient consent for publication: Not applicable. Data availability statement: Data are available upon reasonable request. Competing interests: None declared. Funding: This research received no specific grants from any funding agency in the public, commercial, or not-for-profit sectors. Author contributions: M.M., W.F., M.I. contributed to the conception and design or analysis and interpretation of data. K.U., T.S., A.K., R.N., and N.H. collected data. M.T., K.K., S.Y., J.I., T.T., and M.O. contributed to drafting of the manuscript and revising it critically for important intellectual content. H.O. contributed to final approval of the submitted manuscript. Acknowledgments: None. References Ruben L J Osnabrugge, Darren Mylotte, Stuart J Head, Nicolas M Van Mieghem, Vuyisile T Nkomo, Corinne M LeReun, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol 2013;62:1002–12. 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Comparison of postoperative outcomes following multidetector computed tomography based vs transesophageal echocardiography based annulus sizing for transcatheter aortic valve replacement: a systematic review and meta-analysis. Echocardiography 2020;37:1617–26. Table 1 Table 1 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.docx Supplementtable1.docx Supplementtable2.docx Cite Share Download PDF Status: Published Journal Publication published 25 Nov, 2025 Read the published version in BMC Cardiovascular Disorders → Version 1 posted Editorial decision: Revision requested 24 Mar, 2025 Reviewers agreed at journal 23 Mar, 2025 Reviewers agreed at journal 21 Mar, 2025 Reviewers agreed at journal 21 Mar, 2025 Reviews received at journal 21 Mar, 2025 Reviewers agreed at journal 21 Mar, 2025 Reviews received at journal 20 Mar, 2025 Reviews received at journal 18 Mar, 2025 Reviewers agreed at journal 12 Mar, 2025 Reviews received at journal 10 Mar, 2025 Reviewers agreed at journal 09 Mar, 2025 Reviews received at journal 09 Mar, 2025 Reviewers agreed at journal 09 Mar, 2025 Reviewers agreed at journal 06 Mar, 2025 Reviews received at journal 06 Mar, 2025 Reviewers agreed at journal 04 Mar, 2025 Reviewers invited by journal 26 Feb, 2025 Editor invited by journal 14 Feb, 2025 Editor assigned by journal 11 Feb, 2025 Submission checks completed at journal 11 Feb, 2025 First submitted to journal 09 Feb, 2025 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. 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Center","correspondingAuthor":false,"prefix":"","firstName":"Koji","middleName":"","lastName":"Kuroda","suffix":""},{"id":414279201,"identity":"d98d09c4-1aa8-46dd-8620-143891b70158","order_by":10,"name":"Soichiro Yamashita","email":"","orcid":"","institution":"Hyogo Prefectural Awaji Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Soichiro","middleName":"","lastName":"Yamashita","suffix":""},{"id":414279204,"identity":"9350af1c-03bd-453d-b2ee-c662a0cdb9ac","order_by":11,"name":"Junichi Imanishi","email":"","orcid":"","institution":"Hyogo Prefectural Awaji Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Junichi","middleName":"","lastName":"Imanishi","suffix":""},{"id":414279205,"identity":"2a3eee22-0594-4624-9631-ce03c1c1d1d2","order_by":12,"name":"Takafumi Todoroki","email":"","orcid":"","institution":"Hyogo Prefectural Awaji Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Takafumi","middleName":"","lastName":"Todoroki","suffix":""},{"id":414279208,"identity":"de2f7418-cf31-434a-b604-bc394b69b944","order_by":13,"name":"Masanori Okuda","email":"","orcid":"","institution":"Hyogo Prefectural Awaji Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Masanori","middleName":"","lastName":"Okuda","suffix":""},{"id":414279211,"identity":"0fe83dac-ac7f-405d-96b0-824780b78866","order_by":14,"name":"Hiromasa Otake","email":"","orcid":"","institution":"Kobe University Graduate School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Hiromasa","middleName":"","lastName":"Otake","suffix":""}],"badges":[],"createdAt":"2025-02-09 15:08:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5993165/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5993165/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12872-025-05310-6","type":"published","date":"2025-11-25T15:57:57+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":76280608,"identity":"93a3d3cf-5ffe-43fb-bf22-6da09b9ca372","added_by":"auto","created_at":"2025-02-14 10:32:46","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":43459,"visible":true,"origin":"","legend":"\u003cp\u003ePatient selection flowchart\u003c/p\u003e","description":"","filename":"Figure11.png","url":"https://assets-eu.researchsquare.com/files/rs-5993165/v1/9f916504726d913cead02b83.png"},{"id":76280623,"identity":"37f297c9-3b8b-4d10-83d4-f3e9122ce8c3","added_by":"auto","created_at":"2025-02-14 10:32:48","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":33611,"visible":true,"origin":"","legend":"\u003cp\u003eComparison of days to withdrawal from mechanical support or to initial rehabilitation between the groups\u003c/p\u003e","description":"","filename":"Figure21.png","url":"https://assets-eu.researchsquare.com/files/rs-5993165/v1/a25e660b6aaf3a04be071d20.png"},{"id":76280618,"identity":"51befa9f-4b7a-4e5c-aded-c51aff9baee1","added_by":"auto","created_at":"2025-02-14 10:32:46","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":21616,"visible":true,"origin":"","legend":"\u003cp\u003eComparison of the clinical frailty scale score before admission and at discharge\u003c/p\u003e","description":"","filename":"Figure31.png","url":"https://assets-eu.researchsquare.com/files/rs-5993165/v1/bfd42129f7606ed0fdd14b53.png"},{"id":97179358,"identity":"02928922-2cb0-4700-9680-5a16ecdd967a","added_by":"auto","created_at":"2025-12-01 16:14:58","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":972886,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5993165/v1/ab2f3160-f004-47db-8dc7-d96973c9096b.pdf"},{"id":76280609,"identity":"a157b7c9-f98c-4b3d-8d28-925dd30bf6e3","added_by":"auto","created_at":"2025-02-14 10:32:46","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":18207,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5993165/v1/295565e8984782afcbfa5951.docx"},{"id":76280612,"identity":"2304ef82-4941-459c-9e12-d8e7102dde1c","added_by":"auto","created_at":"2025-02-14 10:32:46","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":24529,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementtable1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5993165/v1/32bece6fead033722abc97d8.docx"},{"id":76280611,"identity":"730dfdde-c140-4557-872b-8b6d1feb2c63","added_by":"auto","created_at":"2025-02-14 10:32:46","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":18911,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementtable2.docx","url":"https://assets-eu.researchsquare.com/files/rs-5993165/v1/4ecdebd0a34a924030fbb816.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy and Safety of Emergent Balloon Aortic Valvuloplasty as a Rescue Therapy for Cardiogenic Shock Due to Severe Aortic Stenosis in Non-TAVI Centers","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eThe incidence of acute decompensated heart failure (ADHF) due to severe aortic stenosis (AS) has been increasing in the aging population [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In particular, the prognosis of patients with AS who present with cardiogenic shock remains poor [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], and the optimal initial treatment remains unclear.\u003c/p\u003e \u003cp\u003eSurgical aortic valve replacement (SAVR), the conventional definitive therapy for AS, is associated with a worse prognosis in patients with ADHF or cardiogenic shock than in hemodynamically stable patients [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Although transcatheter aortic valve implantation (TAVI) has been introduced as another therapeutic option for patients at high surgical risk, previous reports have revealed that the rates of procedural complications and 30-day mortality increased fivefold in emergent TAVI for patients with cardiogenic shock compared to that in elective cases [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. In addition, not all facilities in Japan can perform TAVI, even those specializing in cardiovascular disease.\u003c/p\u003e \u003cp\u003eEmergent balloon aortic valvuloplasty (BAV) is a treatment option for salvaging patients with cardiogenic shock due to severe AS [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. In comparison to TAVI, BAV is less scrutinized and more cost-effective. As a temporary procedure, it is suitable for hemodynamically unstable patients in emergency situations. Recent studies have reported that immediate release of aortic valve obstruction by emergent BAV could improve prognosis, whereas delayed BAV is considered to be directly related to dire outcomes [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis study aimed to assess the efficacy and safety of emergent BAV as a rescue therapy for cardiogenic shock due to severe AS.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and patient population\u003c/h2\u003e \u003cp\u003eThis multicenter retrospective study conducted in six non-TAVI centers (Hyogo Prefectural Awaji Medical Center, Konan Medical Center, National Hospital Organization Kobe Medical Center, Osaka Saiseikai Nakatsu Hospital, Yodogawa Christian Hospital, and Ako City Hospital) included patients hospitalized for cardiogenic shock due to severe AS between January 2015 and July 2022. Cardiogenic shock was defined as the combination of 1) administration of catecholamines, including dobutamine and milrinone, insertion of intra-aortic balloon pump (IABP), or low cardiac index (less than 2.2 L/min/m\u003csup\u003e2\u003c/sup\u003e) and 2) systemic hypoperfusion identified by the combination of several parameters including altered mental status (Glasgow Coma Scale score\u0026thinsp;\u0026lt;\u0026thinsp;15), cold/clammy skin and extremities, oliguria with urine output of less than 30 mL/h, serum lactate level higher than 2.0 mmol/L (18 mg/dL), or systolic blood pressure less than 90 mmHg. The following shock statuses related to causes other than severe AS were excluded from this study: acute coronary syndrome, tamponade, stress cardiomyopathy, pulmonary embolism, myocarditis, severe aortic regurgitation, severe mitral regurgitation/stenosis, or concomitant sepsis or severe bleeding. Furthermore, despite of presenting with cardiogenic shock due to severe aortic stenosis patients who did not wish invasive treatment due to their advanced age, frailty, or comorbidities, were excluded.\u003c/p\u003e \u003cp\u003eParticipants were divided into two groups. The emergent group included patients who underwent BAV within 12 h of admission, and the non-emergent group included patients who underwent BAV more than 12 h after admission.\u003c/p\u003e \u003cp\u003eClinical information, including baseline patient characteristics, procedural details, and clinical outcomes, was carefully reviewed using the electronic medical records from each hospital.\u003c/p\u003e \u003cp\u003e This study was approved by the ethics committees of all six facilities, performed according to the guidelines of the Declaration of Helsinki, and registered in the UMIN Clinical Trial Registry (UMIN 000054925) on July 10th, 2024.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eBAV procedures\u003c/h3\u003e\n\u003cp\u003eAll BAV procedures were performed under local anesthesia following the Japanese standards using a retrograde or antegrade approach at the discretion of each operator [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. In the retrograde arterial approach, balloon catheters were delivered through a 7\u0026ndash;10-Fr sheath via the radial, brachial, or femoral artery. The antegrade transseptal approach was performed using a 12\u0026ndash;14-Fr sheath via the femoral vein. In every case, we attempted to use a right heart catheter before and after BAV to evaluate the hemodynamic changes both pre- and post-BAV. During the procedure, intracardiac or transthoracic echocardiography was performed to assess whether the aortic valve was properly dilated or if the aortic regurgitation had worsened (Supplemental Table\u0026nbsp;1).\u003c/p\u003e\n\u003ch3\u003eStudy endpoints\u003c/h3\u003e\n\u003cp\u003eThe primary endpoints were the 30-day mortality rates and procedural complications, which were described according to the Valve Academic Research Consortium-3 (VARC-3) criteria [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. The secondary endpoints were days to withdrawal from the mechanical support device, days to initial rehabilitation, and clinical frailty scale (CFS) score on discharge. These endpoints were calculated from the date of admission. The start of rehabilitation was defined as the time when the patient started sitting in the wheelchair.\u003c/p\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAll data are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation for continuous variables and as frequencies (percentages) for discrete variables. Continuous variables were analyzed using Student\u0026rsquo;s t-test and the Mann\u0026ndash;Whitney U test according to a normal or non-normal distribution, respectively. The chi-square or Fisher\u0026rsquo;s exact test was performed to compare the proportions of categorical variables. Statistical significance was set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Analyses were performed using the commercially available SPSS software (version 29; SPSS Inc., Chicago, IL, USA).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePatient and public involvement\u003c/h3\u003e\n\u003cp\u003ePatients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003eBaseline patient characteristics\u003c/h2\u003e\n \u003cp\u003eAmong 8230 patients who were hospitalized for heart failure between January 2015 and July 2022, a total of 41 patients with cardiogenic shock due to severe AS were enrolled and divided into the emergent (n\u0026thinsp;=\u0026thinsp;10, 20.0% male, mean age 85.7\u0026thinsp;\u0026plusmn;\u0026thinsp;6.7 years) and non-emergent (n\u0026thinsp;=\u0026thinsp;15, 46.7% male, mean age 89.3\u0026thinsp;\u0026plusmn;\u0026thinsp;5.6 years) groups (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). Sixteen patients (No-BAV patients) who did not undergo BAV during their hospitalization were excluded from the study (Supplemental table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). The baseline characteristics showed no remarkable differences in comorbidities or the CFS score. The Society of Thoracic Surgeons (STS) score and IABP use were significantly higher in the emergent group. Additionally, in the emergent group, BAV was performed as soon as the diagnosis of cardiogenic shock due to severe AS was made; the time from admission to BAV was 3.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1 h. In the non-emergent group, BAV was performed 5 days (median) after admission (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eProcedural data\u003c/h3\u003e\n\u003cp\u003eProcedural data pre- and post-BAV revealed a significant reduction in the mean transaortic gradient (from 67.2\u0026thinsp;\u0026plusmn;\u0026thinsp;26.1 mmHg to 37.4\u0026thinsp;\u0026plusmn;\u0026thinsp;16.6 mmHg; p\u0026thinsp;=\u0026thinsp;0.02, in the emergent group, and from 63.1\u0026thinsp;\u0026plusmn;\u0026thinsp;25.6 mmHg to 32.0\u0026thinsp;\u0026plusmn;\u0026thinsp;16.1 mmHg; p\u0026thinsp;\u0026lt;\u0026thinsp;0.01 in the non-emergent group) and an increase in the aortic valve area (from 0.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.2 cm\u003csup\u003e2\u003c/sup\u003e to 0.7\u0026thinsp;\u0026plusmn;\u0026thinsp;0.2 cm\u003csup\u003e2\u003c/sup\u003e; p\u0026thinsp;=\u0026thinsp;0.01, and from 0.5\u0026thinsp;\u0026plusmn;\u0026thinsp;0.2 cm\u003csup\u003e2\u003c/sup\u003e to 0.8\u0026thinsp;\u0026plusmn;\u0026thinsp;0.3 cm\u003csup\u003e2\u003c/sup\u003e; p\u0026thinsp;=\u0026thinsp;0.02, respectively) (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n\u003cdiv\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eHemodynamic parameter of pre- and post- BAV\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ePre BAV\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ePost BAV\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmergent group\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean pressure gradient (mmHg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e67.2\u0026thinsp;\u0026plusmn;\u0026thinsp;26.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e37.4\u0026thinsp;\u0026plusmn;\u0026thinsp;16.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAVA (cm\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.7\u0026thinsp;\u0026plusmn;\u0026thinsp;0.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCI (L/min/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.6\u0026thinsp;\u0026plusmn;\u0026thinsp;0.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e3.0\u0026thinsp;\u0026plusmn;\u0026thinsp;0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.25\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePCWP (mmHg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e23.7\u0026thinsp;\u0026plusmn;\u0026thinsp;16.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e18.0\u0026thinsp;\u0026plusmn;\u0026thinsp;7.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.37\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eNon-emergent group\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean pressure gradient (mmHg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e63.1\u0026thinsp;\u0026plusmn;\u0026thinsp;25.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e32.0\u0026thinsp;\u0026plusmn;\u0026thinsp;16.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAVA (cm\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.5\u0026thinsp;\u0026plusmn;\u0026thinsp;0.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.8\u0026thinsp;\u0026plusmn;\u0026thinsp;0.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCI (L/min/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.5\u0026thinsp;\u0026plusmn;\u0026thinsp;0.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.7\u0026thinsp;\u0026plusmn;\u0026thinsp;0.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.44\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePCWP (mmHg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e17.0\u0026thinsp;\u0026plusmn;\u0026thinsp;9.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e13.6\u0026thinsp;\u0026plusmn;\u0026thinsp;6.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.35\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003eQuantitative data are shown as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviations.\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003eAVA: aortic valve area; CI: cardiac index; PCWP: pulmonary capillary wedge pressure.\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eThirty-day mortality and procedural complications\u003c/h2\u003e\n \u003cp\u003eThe 30-day mortality rate was not significantly different between the two groups (emergent group, n\u0026thinsp;=\u0026thinsp;1 [10%]; non-emergent group, n\u0026thinsp;=\u0026thinsp;3 [20%]; p\u0026thinsp;=\u0026thinsp;0.63). One patient in the emergent group died of alveolar hemorrhage, and three patients in the non-emergent group died of heart failure (n\u0026thinsp;=\u0026thinsp;2) and cardiogenic shock (n\u0026thinsp;=\u0026thinsp;1). No vascular or access-related complications were observed. One patient experienced stroke on the day after the procedure in the non-emergent group. The percentage of patients who were either ambulatory upon discharge or walking on their own was 50% (n\u0026thinsp;=\u0026thinsp;5) in the emergent group and 33.3% (n\u0026thinsp;=\u0026thinsp;5) in the non-emergent group (p\u0026thinsp;=\u0026thinsp;0.41) (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eClinical outcomes\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eVariables\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eEmergent\u003c/p\u003e\n \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;10)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNon-emergent\u003c/p\u003e\n \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;15)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e30-day mortality, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (10)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (20.0)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.63\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Cardiac death, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2 (13.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Non cardiac death, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (6.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eProcedural complication, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (10)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (6.7)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.76\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Neurologic events, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (6.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Myocardial infarction, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Acute kidney injury, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-New dialysis, among patients not currently on dialysis, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Bleeding and transfusions, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Vascular and access-related complications, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-New conduction disturbance and arrhythmias, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-Post-procedural AR grade\u0026thinsp;\u0026ge;\u0026thinsp;3, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003eQualitative data are presented with frequencies.\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eDays to withdrawal from mechanical support and to initial rehabilitation\u003c/h2\u003e\n \u003cp\u003eThe days to withdrawal from mechanical support, including IABP, ventilator, and non-invasive positive pressure ventilation were 2.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.2 days in the emergent group and 7.8\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6 days in the non-emergent group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01). Moreover, the days to start rehabilitation in the two groups were 4.2\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9 days and 10.8\u0026thinsp;\u0026plusmn;\u0026thinsp;6.5 days, respectively (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003eComparison of the CFS score before admission and at discharge\u003c/h2\u003e\n \u003cp\u003eComparing values before admission to values at discharge, the CFS score was maintained in the emergent group (from 3.8\u0026thinsp;\u0026plusmn;\u0026thinsp;1.0 to 3.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.1; p\u0026thinsp;=\u0026thinsp;0.35) but significantly worsened in the non-emergent group (from 3.8\u0026thinsp;\u0026plusmn;\u0026thinsp;0.9 to 4.6\u0026thinsp;\u0026plusmn;\u0026thinsp;1.2; p\u0026thinsp;=\u0026thinsp;0.03) (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe current study revealed that (1) the 30-day mortality rate for patients with severe AS with cardiogenic shock undergoing BAV was 10% in the emergent group and 20% in the non-emergent group; (2) no intraprocedural complications were observed in this study population; (3) the emergent group required less than half the days of weaning from the ventilator and high-care units than those required by the non-emergent group; and (4) frailty did not progress in the emergent group.\u003c/p\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eCurrent role of BAV\u003c/h2\u003e \u003cp\u003eBAV was introduced as a therapeutic option by Cribier et al. in 1986 [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. The initial reduction in the pressure gradient during the procedure was favorable; however, it did not improve the mid-term prognosis because of the high early restenosis rate. Therefore, the use of BAV decreased dramatically with the advent of TAVI in 2002. Nonetheless, BAV has recently been highlighted as a rescue therapy for hemodynamically unstable patients, even in the TAVI era [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Current national registries in Europe and the United States have disclosed an increase in BAV cases [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e], of which BAV for salvage accounts for approximately 10% of cases [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. This phenomenon could be explained by the fact that the number of cases of cardiogenic shock due to severe AS for which direct AVR is not possible has increased, and emergent BAV is performed in the real world as a salvage therapy.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eOutcomes of emergent BAV in patients with cardiogenic shock\u003c/h2\u003e \u003cp\u003eIn 2018, Debry et al. assessed the outcomes of BAV as a rescue therapy in patients with cardiogenic shock due to severe AS and revealed that the 30-day mortality rate was 47% [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Eugene et al. also reported that the rate of early death was 30% for cardiogenic shock or refractory pulmonary edema [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. These previous reports have again depicted the poor prognosis of patients with cardiogenic shock due to severe AS; however, they also suggest that early intervention toward aortic valve obstruction will improve prognosis. Early direct intervention (within 48 h) for aortic valve obstruction can help prevent the need for high doses of catecholamines, which would decrease the risk of multi-organ failure [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. In this study, although not statistically significant, the 30-day mortality rate in the emergent group (10%) was half of that in the non-emergent group (20%). There is no evidence to determine how quickly treatment should be administered to be effective, but it was revealed that the sooner pulmonary edema is relieved, the better the prognosis [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. This may explain why the emergent group, treated approximately 3.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.1 h after admission, had better outcomes than those of patients in the non-emergent group and previously reported cases of AS with cardiogenic shock. Therefore, reducing the duration of cardiogenic shock until the release of valve obstruction is the key to salvaging patients in the acute phase.\u003c/p\u003e \u003cp\u003eWe also revealed that immediate BAV can promote withdrawal from mechanical support, facilitate rehabilitation, and prevent the deterioration of the CFS score. Being bedridden for a long duration has been known to lead to a reduction in muscle strength by 1% per day, even for a healthy adult [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]; therefore, it is important to shorten the duration in which older patients are bedridden as much as possible due to their already reduced muscle strength [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Moreover, the CFS score at discharge affects the prognosis of patients with heart failure [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. When it comes to bridging TAVI, the preprocedural CFS score is reported to be an independent prognostic factor after undergoing TAVI [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]; thus, maintaining the CFS score in older patients during hospitalization is an inevitable issue for clinicians. Therefore, our findings that emergent BAV may contribute to preventing worsening frailty and promoting a smooth bridge to subsequent definitive therapy support the potential advantages of BAV for critically ill older patients.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eComparison of safety between emergent and non-emergent BAV\u003c/h2\u003e \u003cp\u003eEmergent procedures for hemodynamically unstable patients are high-pressure situations for operators and are generally thought to increase the risk of intraprocedural complications; however, our study showed no significant difference in periprocedural complication rates. Previous reports have also shown lower intraprocedural complication rates in emergent BAV than in emergent TAVI [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. While the treatment targets severe cases with poor prognosis, performing BAV in an emergency setting was not considered to be directly related to adverse events. Additionally, all institutions included in this study were primary hospitals in their respective regions but did not have approval to perform TAVI. As for BAV, a volume-outcome relationship was not observed in the nationwide registry data in Japan [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. BAV may be advantageous in emergency situations as an easy-to-use procedure.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eEmergent TAVI\u003c/h2\u003e \u003cp\u003eTAVI is another therapeutic option for severe AS with cardiogenic shock. Since its introduction in 2002, TAVI use has been increasing rapidly worldwide as a counterpart to SAVR in patients at high surgical risk. Recently, the indications for TAVI have been expanding towards critically ill patients, and the question about the potential use of emergent TAVI in the management of patients with cardiogenic shock currently remains open. Frerker et al. reported a 30-day mortality rate of 33.3% in emergent TAVI for cardiogenic shock, which was significantly higher than that in electively treated patients (7.7%; p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). Moreover, there were no significant differences in the rates of major or minor vascular complications; however, patients with cardiogenic shock developed acute kidney injury significantly more often (29.8% vs. 5.0%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. In 2020, The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy registry revealed that emergent TAVI for cardiogenic shock was associated with higher 30-day mortality (19.1% vs. 4.9%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) and complication rates compared to those in a high-risk cohort that did not present with cardiogenic shock [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThus, to date, emergent TAVI has been reported to have significantly poorer outcomes compared to those for elective cases. However, previous reports have concluded that emergency TAVI appears to be a viable option for patients with cardiogenic shock, considering the originally poor prognosis of patients with AS presenting with cardiogenic shock.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eEmergent BAV and TAVI\u003c/h2\u003e \u003cp\u003eVery few studies have directly compared emergent BAV and TAVI in patients with cardiogenic shock. In 2018, Bongiovannni et al. assessed the early outcomes of emergent TAVI versus emergent BAV followed by elective TAVI in a multicenter cohort. Immediate procedural mortality rate was 8.7% in the emergent TAVI group compared with 20.3% in the emergent BAV group (p\u0026thinsp;=\u0026thinsp;0.19), and rates of cardiovascular mortality after 30 days were comparable in the emergent TAVI and BAV groups (23.8% vs. 33.0%, p\u0026thinsp;=\u0026thinsp;0.40). Significant major vascular complications have been observed after emergent TAVI (p\u0026thinsp;=\u0026thinsp;0.01) and stroke (p\u0026thinsp;=\u0026thinsp;0.01) [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. The latest study evaluating the impact of emergent BAV or TAVI on outcomes in patients with cardiogenic shock revealed that BAV was associated with a short-term mortality benefit, including statistically similar in-hospital mortality rates to those for TAVR and surgical AVR [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThese studies uniformly noted that emergent BAV and TAVI are feasible and associated with acceptable outcomes in the acute phase for patients with cardiogenic shock; however, it was also noted that BAV would yield temporal stabilization of patients with cardiogenic shock, and the mortality rate would increase if patients were not offered definitive therapy.\u003c/p\u003e \u003cp\u003eEmergent TAVI has several limitations. First, the device size may make its use challenging. In emergency situations, the aortic annulus can only be appropriately measured using echocardiography and not multidetector computed tomography (MDCT), which is the current standard for elective situations. The most common post-procedural complication is paravalvular leakage (PVL), and even mild PVL is associated with increased late mortality [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Compared to MDCT, two-dimensional transesophageal echocardiography is associated with a significantly lower incidence of more than moderate PVL after TAVI [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Therefore, performing TAVI without this information may increase the procedural risks. Second, TAVI or emergent TAVI is not available at all hospital sites, and patients with cardiogenic shock cannot be transferred to qualified centers in hemodynamically unstable situations. BAV is simple, less scrutinized, and does not necessarily require MDCT information before the procedure. Therefore, emergent BAV is superior to TAVI, and emergent BAV may also be a therapeutic option in facilities offering TAVI.\u003c/p\u003e \u003cp\u003eThe benefit of emergent BAV lies in its temporary therapeutic effect. First, emergent BAV may be an especially useful strategy if the cause of cardiogenic shock is uncertain or for patients with mixed shock due to bleeding, sepsis, or active infection. Definitive therapies should be offered if patients respond favorably and if severe AS has been proven to be the cause of cardiogenic shock. Second, BAV may allow for a better selection of patients who would benefit from definitive therapies after clinical and hemodynamic stabilization. In the acute phase, it may be challenging to ascertain whether patients with shock are optimal candidates for definitive therapies, including TAVI or SAVR, in terms of frailty, comorbidities, and life expectancy.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eThe results of our study should be interpreted in the context of some limitations. First, the candidates in our study were limited to patients with cardiogenic shock; therefore, the sample size was small, despite it being a multicenter retrospective study. Second, there was a lack of uniformity in the BAV technique, including the selection of the balloon type and size. Third, considering the methodological limitations of the retrospective design, the effects of potential selection bias and unmeasured covariates cannot be excluded. Sixteen patients did not undergo BAV, primarily due to the wishes of the patients and their families. However, various factors remain unclear, such as the timing of the decision or admission, the conditions of each hospital, and the perspectives of the medical staff. Finally, cardiogenic shock was diagnosed retrospectively using electronic medical records, which may have led to the underreporting of cases in which the diagnosis was not accurately recorded.\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eEmergent BAV for cardiogenic shock is a feasible and effective rescue therapy, and earlier BAV is suggested to bring about immediate recovery, prevent frailty, and provide a smooth bridge to subsequent treatment in cardiogenic shock patients due to severe AS.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval:\u0026nbsp;\u003c/strong\u003eThis study was approved by the ethics committees of all six facilities and performed according to the guidelines of the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient consent for publication:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement:\u0026nbsp;\u003c/strong\u003eData are available upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e None declared.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eThis research received no specific grants from any funding agency in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions:\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eM.M., W.F., M.I. contributed to the conception and design or analysis and interpretation of data. K.U., T.S., A.K., R.N., and N.H. collected data. M.T., K.K., S.Y., J.I., T.T., and M.O. contributed to drafting of the manuscript and revising it critically for important intellectual content. H.O. contributed to final approval of the submitted manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u0026nbsp;\u003c/strong\u003eNone.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eRuben L J Osnabrugge, Darren Mylotte, Stuart J Head, Nicolas M Van Mieghem, Vuyisile T Nkomo, Corinne M LeReun, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol 2013;62:1002\u0026ndash;12.\u003c/li\u003e\n\u003cli\u003eVuyisile T Nkomo, Julius M Gardin, Thomas N Skelton, John S Gottdiener, Christopher G Scott, Maurice Enriquez-Sarano Nkomo VT, et al. Burden of valvular heart diseases: a population-based study. Lancet 2006;368:1005\u0026ndash;11. \u003c/li\u003e\n\u003cli\u003eKush P Patel, Anwar Chahal, Michael J Mullen, Krishnaraj Rathod, Andreas Baumbach, Guy Lloyd, et al. Acute decompensated aortic stenosis: state of the art review. Curr Probl Cardiol 2023;48:101422.\u003c/li\u003e\n\u003cli\u003eKazuya Nagao, Tomohiko Taniguchi, Takeshi Morimoto, Hiroki Shiomi, Kenji Ando, Norio Kanamori, et al. Acute heart failure in patients with severe aortic stenosis - insights from the CURRENT AS registry. Circ J 2018;82:874\u0026ndash;85.\u003c/li\u003e\n\u003cli\u003eLuke Masha, Sreekanth Vemulapalli, Pratik Manandhar, Prakash Balan, Pinak Shah, Andrzej S Kosinski, et al. Demographics, procedural characteristics, and clinical outcomes when cardiogenic shock precedes TAVR in the United States. JACC Cardiovasc Interv 2020;13:1314\u0026ndash;25. \u003c/li\u003e\n\u003cli\u003eAntonios Kilias, Maria-Ioanna Stefanou, Martin Steeg, Claudia Plachtzik, Joerg Kirchner, Thomas Walkowiak, et al. Rescue aortic valvuloplasty for severe aortic stenosis is simple and effective in severely hemodynamically compromised patients presenting to centers without on-site heart surgery or TAVI facilities. Heart Vessels 2023;38:957\u0026ndash;63.\u003c/li\u003e\n\u003cli\u003eA B Buchwald, T Meyer, K Scholz, B Schorn, C Unterberg. Efficacy of balloon valvuloplasty in patients with critical aortic stenosis and cardiogenic shock--the role of shock duration. Clin Cardiol 2001;24:214\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eNicolas Debry, Patrick Kone, Flavien Vincent, Gilles Lemesle, C\u0026eacute;dric Delhaye, Guillaume Schurtz, et al. Urgent balloon aortic valvuloplasty in patients with cardiogenic shock related to severe aortic stenosis: time matters. EuroIntervention 2018;14:e519\u0026ndash;25.\u003c/li\u003e\n\u003cli\u003eYoshihito Sakata, Zubair Syed, Michael H Salinger, Ted Feldman. Percutaneous balloon aortic valvuloplasty: antegrade transseptal vs. conventional retrograde transarterial approach. Catheter Cardiovasc Interv 2005;64:314\u0026ndash;21.\u003c/li\u003e\n\u003cli\u003eMasamichi Iwasaki, Akihide Konishi, Mitsuyoshi Takahara, Shun Kohsaka, Masanori Okuda, Takatoshi Hayashi, et al. Volume-outcome relationship in balloon aortic valvuloplasty: results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD). BMJ Open 2023;13:e073597. \u003c/li\u003e\n\u003cli\u003ePhilippe G\u0026eacute;n\u0026eacute;reux, Nicolo Piazza, Maria C Alu, Tamim Nazif, Rebecca T Hahn, Philippe Pibarot, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J 2021;42:1825\u0026ndash;57.\u003c/li\u003e\n\u003cli\u003eA Cribier, T Savin, N Saoudi, P Rocha, J Berland, B Letac. Percutaneous transluminal valvuloplasty of acquired aortic stenosis in elderly patients: an alternative to valve replacement? Lancet 1986;1:63\u0026ndash;7.\u003c/li\u003e\n\u003cli\u003eMuhammed Z Khawaja, Manav Sohal, Haseeb Valli, Rafal Dworakowski, Stephen J Pettit, David Roy, et al. Standalone balloon aortic valvuloplasty: indications and outcomes from the UK in the transcatheter valve era. Catheter Cardiovasc Interv 2013;81:366\u0026ndash;73.\u003c/li\u003e\n\u003cli\u003eApurva O Badheka, Nileshkumar J Patel, Vikas Singh, Neeraj Shah, Ankit Chothani, Kathan Mehta, et al. Percutaneous aortic balloon valvotomy in the United States: a 13-year perspective. Am J Med 2014;127:744\u0026ndash;753.e3.\u003c/li\u003e\n\u003cli\u003eTomoyo Hamana, Masamichi Iwasaki, Toshiro Shinke, Tatsuya Kokawa, Yuta Fukuishi, Ryota Masaki, et al. Prognostic impact of the clinical frailty scale after balloon aortic valvuloplasty. Circ Rep 2020;2:322\u0026ndash;9.\u003c/li\u003e\n\u003cli\u003eMarc Eug\u0026egrave;ne, Marina Urena, J\u0026eacute;r\u0026eacute;mie Abtan, Jos\u0026eacute;-Luis Carrasco, Walid Ghodbane, Patrick Nataf, et al. Effectiveness of rescue percutaneous balloon aortic valvuloplasty in patients with severe aortic stenosis and acute heart failure. Am J Cardiol 2018;121:746\u0026ndash;50.\u003c/li\u003e\n\u003cli\u003eGuyton AC, Lindsey AW. Effect of elevated left atrial pressure and decreased plasma protein concentration on the development of pulmonary edema. Circ Res 1959;7:649\u0026ndash;57.\u003c/li\u003e\n\u003cli\u003eWenkang Wang, Chuanjie Xu, Xinglong Ma, Xiaoming Zhang, Peng Xie. Intensive care unit-acquired weakness: a review of recent progress with a look toward the future. Front Med (Lausanne) 2020;7:559789.\u003c/li\u003e\n\u003cli\u003eTome Ikezoe, Natsuko Mori, Masatoshi Nakamura, Noriaki Ichihashi. Effects of age and inactivity due to prolonged bed rest on atrophy of trunk muscles. Eur J Appl Physiol 2012;112:43\u0026ndash;8.\u003c/li\u003e\n\u003cli\u003eNiraliben B K Chokshi, Bratati Karmakar, Shahab K Pathan, Vikram Joshi, Dhwani M Gohel, David S Coulshed, et al. A systematic review of frailty scores used in heart failure patients. Heart Lung Circ 2023;32:441\u0026ndash;53.\u003c/li\u003e\n\u003cli\u003eNorihisa Miyawaki, Kenichi Ishizu, Shinichi Shirai, Katsunori Miyahara, Ko Yamamoto, Tomohiro Suenaga, et al. Impact of the clinical frailty scale on long-term outcomes after transcatheter aortic valve implantation. Am Heart J 2024;275:141\u0026ndash;50.\u003c/li\u003e\n\u003cli\u003eRaunak M Nair, Sanchit Chawla, Bahaa Abdelghaffar, Feras Alkhalaieh, Agam Bansal, Rishi Puri, et al. Comparison of contemporary treatment strategies in patients with cardiogenic shock due to severe aortic stenosis. J Am Heart Assoc 2024;13:e033601.\u003c/li\u003e\n\u003cli\u003eChristian Frerker, Jury Schewel, Michael Schl\u0026uuml;ter, Dimitry Schewel, Hassan Ramadan, Tobias Schmidt, et al. Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis. EuroIntervention 2016;11:1530\u0026ndash;6.\u003c/li\u003e\n\u003cli\u003eDario Bongiovanni, Constantin K\u0026uuml;hl, Sabine Bleiziffer, Lynne Stecher, Felix Poch, Martin Greif, et al. Emergency treatment of decompensated aortic stenosis. Heart 2018;104:23\u0026ndash;9.\u003c/li\u003e\n\u003cli\u003eSusheel K Kodali, Mathew R Williams, Craig R Smith, Lars G Svensson, John G Webb, Raj R Makkar, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686\u0026ndash;95.\u003c/li\u003e\n\u003cli\u003eTang G, Lv Q, He X. Comparison of postoperative outcomes following multidetector computed tomography based vs transesophageal echocardiography based annulus sizing for transcatheter aortic valve replacement: a systematic review and meta-analysis. Echocardiography 2020;37:1617\u0026ndash;26.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table 1","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"aortic stenosis, balloon aortic valvuloplasty, cardiogenic shock, retrospective study","lastPublishedDoi":"10.21203/rs.3.rs-5993165/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5993165/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThe prognosis of aortic stenosis (AS) with cardiogenic shock remains poor, and optimal initial treatment remains unclear. Emergent balloon aortic valvuloplasty (BAV) is a treatment option for salvage and recent studies have reported that early release of valve obstruction by emergent BAV could improve prognosis. This study aimed to assess the efficacy and safety of emergent BAV for severe AS with cardiogenic shock.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA total of 41 patients with severe AS in cardiogenic shock were enrolled and divided into the emergent (underwent BAV within 12h of admission, n\u0026thinsp;=\u0026thinsp;10) and non-emergent (underwent BAV more than 12h after admission, n\u0026thinsp;=\u0026thinsp;15) groups, after excluding 16 patients who did not undergo BAV. The primary endpoints were the 30-day mortality rate and procedural complications. The secondary endpoints were days to withdrawal from the mechanical circulatory support (MCS), days to initial rehabilitation, and clinical frailty scale (CFS) score at discharge.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe 30-day mortality rate was not significantly different between the emergent and non-emergent groups (10% vs. 20%, p\u0026thinsp;=\u0026thinsp;0.63). One patient experienced stroke after procedure in the non-emergent group. The days to withdrawal from MCS and to start rehabilitation were earlier in emergent group (2.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.2 days vs. 7.8\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6 days; p\u0026thinsp;\u0026lt;\u0026thinsp;0.01, 4.2\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9 days vs. 10.8\u0026thinsp;\u0026plusmn;\u0026thinsp;6.5 days; p\u0026thinsp;\u0026lt;\u0026thinsp;0.01). The CFS score at discharge in the emergent group was maintained compared to before admission (from 3.8\u0026thinsp;\u0026plusmn;\u0026thinsp;1.0 to 3.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.1; p\u0026thinsp;=\u0026thinsp;0.35), whereas worsened in the non-emergent group (from 3.8\u0026thinsp;\u0026plusmn;\u0026thinsp;0.9 to 4.6\u0026thinsp;\u0026plusmn;\u0026thinsp;1.2; p\u0026thinsp;=\u0026thinsp;0.03).\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eEmergent BAV for cardiogenic shock is feasible, and earlier BAV would provide immediate recovery and prevent deterioration of frailty.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of Emergent Balloon Aortic Valvuloplasty as a Rescue Therapy for Cardiogenic Shock Due to Severe Aortic Stenosis in Non-TAVI Centers","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-02-14 10:32:40","doi":"10.21203/rs.3.rs-5993165/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision 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