Innovations in Cardiovascular Surgery: Safety and Outcomes of Transcatheter Aortic Valve Implantation

Innovations in Cardiovascular Surgery: Safety and Outcomes of Transcatheter Aortic Valve Implantation | 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 Innovations in Cardiovascular Surgery: Safety and Outcomes of Transcatheter Aortic Valve Implantation Silpa Choday, Aubin Sandio, Austin Saugstad, Ali Morado This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4736484/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 Transcatheter aortic valve implantation (TAVI) has emerged as a transformative innovation in cardiovascular surgery, offering a minimally invasive alternative to conventional open-heart surgery for patients with severe aortic stenosis. It is initially introduced as a treatment option for high-risk surgical candidates, TAVI has progressively expanded its indications to encompass intermediate and even low-risk patients, supported by robust clinical trials demonstrating comparable or superior outcomes to surgical aortic valve replacement. The procedural safety of TAVI has significantly improved with advancements in device technology, procedural techniques, and operator experience, leading to lower rates of procedural complications such as stroke, vascular injury, and paravalvular leak. Furthermore, the long-term effectiveness of TAVI is underscored by favorable outcomes in terms of symptom relief, functional improvement, and overall survival. This review discussed the current evidence on the safety and outcomes of TAVI, emphasizing its role in reshaping cardiovascular surgery paradigms and expanding treatment options for patients deemed high-risk or unsuitable for traditional surgery. As ongoing research continues to refine patient selection criteria, optimize procedural techniques, and enhance postoperative management, TAVI stands poised to further enhance cardiovascular care and outcomes in the foreseeable future. Aortic stenosis Transcatheter aortic valve replacement Transcatheter aortic valve implantation safety efficacy Introduction Aortic Stenosis is the most common cause of valvular heart disease and can be fatal if left untreated. According to the American College of Cardiology, this is a class I recommendation, one-third of the patients over the age of 75 are not being referred for surgery due to concern about surgical risk associated with the patient’s age, and other co-morbidities [ 1 ]. Transcatheter aortic valve implantation (TAVI), arose as a complementary option to surgical aortic valve replacement (SAVR) [ 2 ]. The standard treatment outcomes were established in a [Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score >_8–15%] and d US Core Valve high-risk trials that TAVR is comparable to SAVR [ 3 – 5 ]. Transcatheter aortic valve implantation (TAVI) is a less invasive alternative and is the treatment of choice for high-operative risk patients compared to SAVR [ 6 ]. Developments in technology, refinements in procedures, and increased experience have resulted in improved treatment outcomes, resulting in an increased interest in using TAVI in patients [ 2 ]. In this review, we will summarize the most recent evidence on safety, the efficacy of the treatment outcomes, and emerging concepts in the field of TAVR. Discussion Aortic stenosis (AS) has a predictable prevalence of 12–13%, and most of the most severe AS at age ≥ 75 is in the Western world, making it one of the most common structural heart diseases in the elderly [ 7 ]. Traditionally, severe AS was treated by SAVR or medical management [ 8 ]. TAVR has transformed the management of patients with severe aortic stenosis. Originally it was restricted to inoperable or high-risk patients, the indication of TAVR has expanded to low-risk and intermediate patients, and a series of clinical trials were conducted comparing TAVR with SAVR. TAVR is approved for all patients irrespective of age and all risk profiles [ 9 ]. It has shown good outcomes in short-term, 1-year, and 2-years with low-risk profiles and at the age of 70s [ 9 ]. Frailty in older adults Frailty is one of the risk factors for death and can cause disability after TAVR and SAVR. FRATILYT AVR is designed to investigate the frailty in the older population who is undergoing SAVR and TAVR [ 10 ]. It predicts mortality and disability after an AV procedure. It measures cognitive impairment, Lower extremity weakness, anemia, and hypoalbuminemia. Among the other frailty scales EFT outperformed, was quick and easy to predict the value, and has high reliability. In addition to frailty markers, other factors associated with poorer outcomes are atrial fibrillation, and pulmonary and renal disease when the patient is dialysis dependent [ 11 ]. Patients who are obese are likely to survive but have functional limitations after TAVR. It is beneficial to have cardiac rehabilitation in obese patients who are frail to improve their disability and functional decline [ 14 ]. Comparison of TAVR Vs SAVR The long-term outcomes regarding the clinical and durability of transcatheter heart valves are better and more reassuring for TAVR. Based on one study patients who underwent TAVR in the USA had a 1-year mortality of 23%, stroke of 4%, but a combination of stroke and death of 26% [ 11 ]. After 5 years of follow-up in intermediate-risk patients with aortic stenosis, and chronic kidney disease, AKI is more common with SAVR than TAVR, but the other outcomes as death, stroke, progression to dialysis and readmission are similar in both groups [ 12 ]. At lower surgical risk patients after 6 years of follow-up, the all-cause mortality has only a slight difference, but TAVR (42.5%) is better than SAVR (37.7%), but the structural heart deterioration (SVD) is less for TAVR compared to SAVR, Nonstructural valve deterioration was similar in both groups [ 13 ]. Another study showed that there is no significant difference in TAVR and SAVR after 8 years of follow-up, the all-cause mortality, myocardial infarction and stroke, and composite outcomes, but the risk of structural valve deterioration is significantly lower with TAVR compared to SAVR [ 15 ]. In one study, that compared TAVI (n = 458) and Surgery (n = 455), it showed that TAVI is superior to surgery among patients aged > 70 years [ 1 ]. TAVR is now recommended for longer life expectancy patients with TAVR [ 16 ]. TAVR in women Men and women have a similar prevalence of valvular disease [ 17 ]. Women undergo SAVR for AS less frequently than men and have worse outcomes with SAVR than men [ 18 ] SAVR in women has been correlated with worse in-hospital mortality and higher cost compared with men [ 18 ]. Numerous studies had reported mortality benefits for women with TAVR. A study by Siontis et al.22, for 2-year mortality - TAVR showed a 13% relative risk reduction compared to SAVR. This was observed to be more beneficial for females undergoing a transfemoral approach [ 19 ]. In another Panoulas et al1 study of gender‐specific survival combining 4 randomized controlled trials of TAVR vs SAVR with a total of 3758 patients (female: 1706, male 2052), women had significantly lower mortality than male 1 and 2 years with a reduction of 31% at 1 year and 26% at 2 years. The difference in treatment was statistically significant with p < 0.05 [ 17 ]. TAVR over age 90 TAVR can be performed in nonagenarians with high procedural success rates and acceptable in-hospital, 30‐day, and 1‐year mortality rates. Most studies for patients above age 90 show a procedural success rate greater than 95% and an absolute stroke rate of less than 4%, with no effect modification by age. In a study by Sun et al, there is a similar rate of major bleeding in patients above and below 90 years, with a relative risk of 1.17 (95% CI 1.04–1.32) [ 20 ]. In contrast, if the nonfemoral access techniques were used the rate of vascular complication was increased for patients above 90 years. From the FRAILTY‐AVR study, nonfemoral access had higher 30‐day mortality in frail patients (odds ratio 3.91, 95% CI 1.48–10.31) [ 21 ]. Most studies show higher risk in nonfemoral access though the comparison of femoral and nonfemoral access routes is clearly not randomized but favors femoral access TAVR in older patients [ 22 ]. On average, patients above 90 years can tolerate the TAVR procedure quite well, with low in-hospital mortality and low adverse effects. This subgroup of patients is under‐represented or at the very least highly selected in randomized trials, Age alone is inadequate to stratify patients, there must be deeper evaluations for frailty such as that offered by a comprehensive geriatric assessment. Finally, the process of mutual decision‐making is predominant to make sure that the course of action is patient‐centered and considers the anticipated risks and benefits with the nonagenarian's preferences and principles [ 22 ]. Delirium After TAVR The development of TAVR has made an increased number of the elderly patient population with high comorbidities and frailty eligible for treatment compared to the pre-TAVR [ 23 ]. Post-procedure is a frequent complication with disturbance in consciousness, cognition, and attention. The rate of delirium varies from 2–4% [ 24 ]. The incidence of delirium yearly in the general population is anticipated at 1–2%, this number increases with age and can be up to 14% in elderly patients (age > 85) [ 25 ]. In hospital admissions, delirium is noted in 14–24% [ 25 ]. The pooled incidences of delirium after cardiac surgery is noted to be 8–20% [ 26 ][ 27 ]. For TAVR the pooled incidence of delirium is 8–23% [ 28 , 29 ]. As TAVR is rapidly advancing there is improving awareness of delirium for preventive and therapeutic options [ 30 ]. Delirium has been related to impaired recovery, increased length of hospital stays, high cost for index hospitalization, increased risk of readmissions within 6 months, and mortality [ 31 ]. Treatment for delirium is established mainly on nonpharmacological strategies identifying and eliminating the trigger factors such as pain and infection, and optimization of environmental factors. TAVR-associated delirium can be avoided by addressing the predisposing and precipitating factors. In different hospital settings, interventions that reduced the incidence of delirium resulted in improved clinical outcomes and reduced costs [ 32 ]. Procedural improvements With the continuous development of TAVR, many advancements have been implemented in various procedures to improve outcomes and decrease the procedure burden. The primary goals of the procedure are to perform under local anesthesia and percutaneously [ 33 ]. Preventing general anesthesia during the procedure can have improved outcomes and reduced length of in-hospital stay [ 34 ]. This approach, however, excludes the standard use of transesophageal echocardiography (TEE). Monitoring of post-procedural aortic regurgitation with advanced TEE or non-imaging methods is needed [ 35 ]. The promotion of early mobilization can be achieved by using balloon-expandable sheaths and totally percutaneous TF-TAVR with advanced vascular closure devices [ 33 ]. Cost-effectiveness Apart from clinical outcomes, the price of the procedure is an important factor when choosing a treatment modality, notably in low healthcare-budget countries [ 33 ]. SAVR is associated with high predicted risk, and high costs when stratified by surgical risk category [ 36 ]. The benefits of TAVR come at a cost-effectively adequate cost in the higher-risk groups, but this may not apply to low-risk patients [ 37 ]. Ultimately, the anticipated variations in the cost of TAVR prostheses can be an important influencer of cost-efficacy when comparing TAVR and SAVR [ 38 ]. Conclusion TAVR is a growing procedure with constant advancements in methods, selection of patients, and utilization of resources and devices. The outcomes have mostly been reliable and progressed since the launch of this procedure. However, there is room to decrease complications and enhance outcomes, which drives innovation in this area. In a very short time, there is a lot of tremendous evidence accumulated for TAVR as the patient population that benefits from this procedure continues to increase with time. As there is an upward trend in the preference for TAVR, there is also a trend toward improving the technology and techniques. Declarations Acknowledgements: None Institutional Review Board Approval: Not needed as the data has been collected from public databases. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Availability of data and material: Data has been collected from PubMed, Crossref and Google Scholar Conflict of interests: The authors declare that they have no competing interests. Financial Disclosures/Funding: Not applicable. Informed Consent: Not applicable Authors' contributions: Silpa Choday as the first author analyzed and interpreted the data, wrote most of the sections, and was a major contributor to writing the manuscript. Aubin as a second author analyzed the sections and was a contributor to the few parts of the manuscript. Austin as a third author collected relevant articles and contributed to a few sections of the article. Ali as a senior author reviewed the article and made necessary changes to the manuscript. All authors read and approved the final manuscript. References Arora S, Misenheimer JA, Ramaraj R. Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status. Tex Heart Inst J. 2017 Feb 1;44(1):29-38. doi: 10.14503/THIJ-16-5852. Erratum in: Tex Heart Inst J. 2018 Apr 7;45(2):122. PMID: 28265210; PMCID: PMC5317356. Siontis GCM, Overtchouk P, Cahill TJ, Modine T, Prendergast B, Praz F, Pilgrim T, Petrinic T, Nikolakopoulou A, Salanti G, Søndergaard L, Verma S, Jüni P, Windecker S. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis. Eur Heart J. 2019 Oct 7;40(38):3143-3153. doi: 10.1093/eurheartj/ehz275. PMID: 31329852. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686–1695 Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson MJ, Svensson LG; PARTNER 1 trial Investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015;385:2477–2484. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–1798 UK TAVI Trial Investigators; Toff WD, Hildick-Smith D, Kovac J, Mullen MJ, Wendler O, Mansouri A, Rombach I, Abrams KR, Conroy SP, Flather MD, Gray AM, MacCarthy P, Monaghan MJ, Prendergast B, Ray S, Young CP, Crossman DC, Cleland JGF, de Belder MA, Ludman PF, Jones S, Densem CG, Tsui S, Kuduvalli M, Mills JD, Banning AP, Sayeed R, Hasan R, Fraser DGW, Trivedi U, Davies SW, Duncan A, Curzen N, Ohri SK, Malkin CJ, Kaul P, Muir DF, Owens WA, Uren NG, Pessotto R, Kennon S, Awad WI, Khogali SS, Matuszewski M, Edwards RJ, Ramesh BC, Dalby M, Raja SG, Mariscalco G, Lloyd C, Cox ID, Redwood SR, Gunning MG, Ridley PD. Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1875-1887. doi: 10.1001/jama.2022.5776. PMID: 35579641; PMCID: PMC9115619. Kumar V, Sandhu GS, Harper CM, Ting HH, Rihal CS. Transcatheter Aortic Valve Replacement Programs: Clinical Outcomes and Developments. J Am Heart Assoc. 2020 Apr 21;9(8):e015921. doi: 10.1161/JAHA.120.015921. Epub 2020 Apr 17. PMID: 32301367; PMCID: PMC7428521. Block PC, Palacios IF. Clinical and hemodynamic follow‐up after percutaneous aortic valvuloplasty in the elderly. Am J Cardiol. 1988;62:760–763. [PubMed] [Google Scholar] Yerasi C, Rogers T, Forrestal BJ, Case BC, Khan JM, Ben-Dor I, Satler LF, Garcia-Garcia HM, Cohen JE, Kitahara H, Shults C, Waksman R. Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-Risk Patients With Severe Aortic Stenosis. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1169-1180. doi: 10.1016/j.jcin.2021.03.058. PMID: 34112453. Afilalo J, Lauck S, Kim DH, Lefèvre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Généreux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7. PMID: 28693934. Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O'Brien SM, Vemulapalli S, Edwards FH, Carroll J, Shahian D, Grover F, Tuzcu EM, Peterson ED, Brindis RG, Mack MJ; STS/ACC TVT Registry. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015 Mar 10;313(10):1019-28. doi: 10.1001/jama.2015.1474. PMID: 25756438. Garcia S, Cubeddu RJ, Hahn RT, Ternacle J, Kapadia SR, Kodali SK, Thourani VH, Jaber WA, Asher CR, Elmariah S, Makkar R, Webb JG, Herrmann HC, Lu M, Devireddy CM, Malaisrie SC, Smith CR, Mack MJ, Sorajja P, Cavalcante JL, Goessl M, Shroff GR, Leon MB, Pibarot P. 5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease. JACC Cardiovasc Interv. 2021 Sep 27;14(18):1995-2005. doi: 10.1016/j.jcin.2021.07.004. PMID: 34556273. Søndergaard L, Ihlemann N, Capodanno D, Jørgensen TH, Nissen H, Kjeldsen BJ, Chang Y, Steinbrüchel DA, Olsen PS, Petronio AS, Thyregod HGH. Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk. J Am Coll Cardiol. 2019 Feb 12;73(5):546-553. doi: 10.1016/j.jacc.2018.10.083. PMID: 30732707. Sannino A, Schiattarella GG, Toscano E, Gargiulo G, Giugliano G, Galderisi M, Losi MA, Stabile E, Cirillo P, Imbriaco M, Grayburn PA, Trimarco B, Esposito G. Meta-Analysis of Effect of Body Mass Index on Outcomes After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2017 Jan 15;119(2):308-316. doi: 10.1016/j.amjcard.2016.09.031. Epub 2016 Oct 7. PMID: 27839771. Jørgensen TH, Thyregod HGH, Ihlemann N, Nissen H, Petursson P, Kjeldsen BJ, Steinbrüchel DA, Olsen PS, Søndergaard L. Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur Heart J. 2021 Aug 7;42(30):2912-2919. doi: 10.1093/eurheartj/ehab375. Sondergaard L. Transcatheter aortic valve implantation in patients with longer life expectancy: what measures are needed? Eur Heart J 2019;40:1331–1333. [PubMed] [Google Scholar]. Panoulas VF, Francis DP, Ruparelia N, et al. Female‐specific survival advantage from transcatheter aortic valve implantation over surgical aortic valve replacement: meta‐analysis of the gender subgroups of randomised controlled trials including 3758 patients. Int J Cardiol. 2018;250:66–72. [PubMed] [Google Scholar] Chaker Z, Badhwar V, Alqahtani F, et al. Sex differences in the utilization and outcomes of surgical aortic valve replacement for severe aortic stenosis. J Am Heart Assoc. 2017;6:pii:e006370. [PMC free article] [PubMed] [Google Scholar] Siontis GC, Praz F, Pilgrim T, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta‐analysis of randomized trials. Eur Heart J. 2016;37:3503–3512. [PubMed] [Google Scholar]. Sun Y, Liu X, Chen Z, et al. Meta‐analysis of predictors of early severe bleeding in patients who underwent transcatheter aortic valve implantation. Am J Cardiol. 2017;120(4):655‐661. [PubMed] [Google Scholar] Drudi LM, Ades M, Asgar A, et al. Interaction between frailty and access site in older adults undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2018;11(21):2185‐2192. [PubMed] [Google Scholar] Galatas C, Afilalo J. Transcatheter aortic valve replacement over age 90: Risks vs benefits. Clin Cardiol. 2020 Feb;43(2):156-162. doi: 10.1002/clc.23310. Epub 2019 Dec 16. PMID: 31840834; PMCID: PMC7021650. A.P. Durko, R.L. Osnabrugge, N.M. Van Mieghem, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections Eur Heart J, 39 (2018), pp. 2635-2642 A. Soundhar, R. Udesh, A. Mehta, et al. Delirium following transcatheter aortic valve replacement: National Inpatient Sample analysis J Cardiothorac Vasc Anesth, 31 (2017), pp. 1977-1984 S.K. Inouye, R.G. Westendorp, J.S. Saczynski Delirium in elderly people Lancet, 383 (2014), pp. 911-922 J.L. Rudolph, E.R. Marcantonio Review articles: postoperative delirium: acute change with long-term implications Anesth Analg, 112 (2011), pp. 1202-1211 E. Crocker, T. Beggs, A. Hassan, et al. Long-term effects of postoperative delirium in patients undergoing cardiac operation: a systematic review Ann Thorac Surg, 102 (2016), pp. 1391-1399 E. Tilley, P.J. Psaltis, T. Loetscher, et al. Meta-analysis of prevalence and risk factors for delirium after transcatheter aortic valve implantation 29.M. Abawi, M. Pagnesi, P. Agostoni, et al. Postoperative delirium in individuals undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis J Am Geriatr Soc, 66 (2018), pp. 2417-2424 K. Ibrahim, C.P. McCarthy, K.J. McCarthy, et al. Delirium in the cardiac intensive care unit J Am Heart Assoc, 7 (2018), Article e008568 B.J. Potter, C. Thompson, P. Green, S. Clancy Incremental cost and length of stay associated with postprocedure delirium in transcatheter and surgical aortic valve replacement patients in the United States Catheter Cardiovasc Interv, 93 (2019), pp. 1132-1136 F.C. Bakker, A. Persoon, S.J.H. Bredie, et al. The CareWell in Hospital program to improve the quality of care for frail elderly inpatients: results of a before-after study with focus on surgical patients Am J Surg, 208 (2014), pp. 735-746. Durko AP, Osnabrugge RL, Kappetein AP. Long-term outlook for transcatheter aortic valve replacement. Trends Cardiovasc Med. 2018 Apr;28(3):174-183. doi: 10.1016/j.tcm.2017.08.004. Epub 2017 Aug 10. PMID: 28838702. G.M. Fröhlich, A.J. Lansky, J. Webb, M. Roffi, S. Toggweiler, M. Reinthaler, et al. Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)––systematic review and meta-analysis BMC Med, 12 (2014), p. 41 E. Van Belle, A. Rauch, F. Vincent, E. Robin, M. Kibler, J. Labreuche, et al. Von Willebrand factor multimers during transcatheter aortic-valve replacement N Engl J Med, 375 (2016), pp. 335-344. R.L.J. Osnabrugge, A.M. Speir, S.J. Head, C.E. Fonner, E. Fonner Jr, G. Ailawadi, et al. Costs for surgical aortic valve replacement according to preoperative risk categories Ann Thorac Surg, 96 (2013), pp. 500-506 M.R. Reynolds, S.J. Baron, D.J. Cohen Economic implications of transcatheter aortic valve replacement in patients at intermediate surgical risk Circulation, 134 (2016), p. 1416, 10.1161/CIRCULATIONAHA.116.021962 G. Ailawadi, D.J. LaPar, A.M. Speir, R.K. Ghanta, L.T. Yarboro, I.K. Crosby, et al. Contemporary costs associated with transcatheter aortic valve replacement: a propensity-matched cost analysis Ann Thorac Surg, 101 (2016), pp. 154-161 Additional Declarations The authors declare no competing interests. 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4736484","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":326596370,"identity":"04d47626-cc5d-4a35-a8cc-8992aaa16086","order_by":0,"name":"Silpa Choday","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3UlEQVRIiWNgGAWjYFACHoYDD4AkP3sDkGNgQaSWBAYGGcmeAyAtEsRpYQBqsTG4kQDiEaHF4PzZgwcSd9jxGNx8fnXDjwIJBv727gT8Wm7kJRxIPJPMI3k7p+xmD9BhEmfObiCghcfgQGIbMw/f7Zw0IFsC6J1cAlrOnwFpqedhuHkm7eYforQcyAFpOcwjcIP92G2ibJG8AdJy5jiPZE8O220ZAwkegn7hO3/G+MPHHdX2/OzHn91888dGjr+9F78WMGBsAJE8BmCSsHKEFvYHxKkeBaNgFIyCEQcAuxVNfIIov00AAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-6171-7609","institution":"","correspondingAuthor":true,"prefix":"","firstName":"Silpa","middleName":"","lastName":"Choday","suffix":""},{"id":326596380,"identity":"dddb56be-ddee-4c79-9f16-1ceac0705a55","order_by":1,"name":"Aubin Sandio","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Aubin","middleName":"","lastName":"Sandio","suffix":""},{"id":326596371,"identity":"0d3f667f-3d20-4496-b57c-f33f0bfc359f","order_by":2,"name":"Austin Saugstad","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Austin","middleName":"","lastName":"Saugstad","suffix":""},{"id":326596372,"identity":"d6845476-0083-439a-956f-e68578974747","order_by":3,"name":"Ali Morado","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Ali","middleName":"","lastName":"Morado","suffix":""}],"badges":[],"createdAt":"2024-07-13 21:41:07","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-4736484/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4736484/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":60387945,"identity":"c76c349e-ca40-4487-8c3d-9a9bb03c1874","added_by":"auto","created_at":"2024-07-16 08:29:09","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":248621,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4736484/v1/15321124-482f-4552-9bf1-365cb23b3410.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eInnovations in Cardiovascular Surgery: Safety and Outcomes of Transcatheter Aortic Valve Implantation\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAortic Stenosis is the most common cause of valvular heart disease and can be fatal if left untreated. According to the American College of Cardiology, this is a class I recommendation, one-third of the patients over the age of 75 are not being referred for surgery due to concern about surgical risk associated with the patient\u0026rsquo;s age, and other co-morbidities [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Transcatheter aortic valve implantation (TAVI), arose as a complementary option to surgical aortic valve replacement (SAVR) [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The standard treatment outcomes were established in a [Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score \u0026gt;_8\u0026ndash;15%] and d US Core Valve high-risk trials that TAVR is comparable to SAVR [\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Transcatheter aortic valve implantation (TAVI) is a less invasive alternative and is the treatment of choice for high-operative risk patients compared to SAVR [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Developments in technology, refinements in procedures, and increased experience have resulted in improved treatment outcomes, resulting in an increased interest in using TAVI in patients [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In this review, we will summarize the most recent evidence on safety, the efficacy of the treatment outcomes, and emerging concepts in the field of TAVR.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAortic stenosis (AS) has a predictable prevalence of 12\u0026ndash;13%, and most of the most severe AS at age\u0026thinsp;\u0026ge;\u0026thinsp;75 is in the Western world, making it one of the most common structural heart diseases in the elderly [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Traditionally, severe AS was treated by SAVR or medical management [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. TAVR has transformed the management of patients with severe aortic stenosis. Originally it was restricted to inoperable or high-risk patients, the indication of TAVR has expanded to low-risk and intermediate patients, and a series of clinical trials were conducted comparing TAVR with SAVR. TAVR is approved for all patients irrespective of age and all risk profiles [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. It has shown good outcomes in short-term, 1-year, and 2-years with low-risk profiles and at the age of 70s [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eFrailty in older adults\u003c/h3\u003e\n\u003cp\u003eFrailty is one of the risk factors for death and can cause disability after TAVR and SAVR. FRATILYT AVR is designed to investigate the frailty in the older population who is undergoing SAVR and TAVR [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. It predicts mortality and disability after an AV procedure. It measures cognitive impairment, Lower extremity weakness, anemia, and hypoalbuminemia. Among the other frailty scales EFT outperformed, was quick and easy to predict the value, and has high reliability. In addition to frailty markers, other factors associated with poorer outcomes are atrial fibrillation, and pulmonary and renal disease when the patient is dialysis dependent [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Patients who are obese are likely to survive but have functional limitations after TAVR. It is beneficial to have cardiac rehabilitation in obese patients who are frail to improve their disability and functional decline [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eComparison of TAVR Vs SAVR\u003c/h3\u003e\n\u003cp\u003eThe long-term outcomes regarding the clinical and durability of transcatheter heart valves are better and more reassuring for TAVR. Based on one study patients who underwent TAVR in the USA had a 1-year mortality of 23%, stroke of 4%, but a combination of stroke and death of 26% [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. After 5 years of follow-up in intermediate-risk patients with aortic stenosis, and chronic kidney disease, AKI is more common with SAVR than TAVR, but the other outcomes as death, stroke, progression to dialysis and readmission are similar in both groups [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. At lower surgical risk patients after 6 years of follow-up, the all-cause mortality has only a slight difference, but TAVR (42.5%) is better than SAVR (37.7%), but the structural heart deterioration (SVD) is less for TAVR compared to SAVR, Nonstructural valve deterioration was similar in both groups [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Another study showed that there is no significant difference in TAVR and SAVR after 8 years of follow-up, the all-cause mortality, myocardial infarction and stroke, and composite outcomes, but the risk of structural valve deterioration is significantly lower with TAVR compared to SAVR [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. In one study, that compared TAVI (n\u0026thinsp;=\u0026thinsp;458) and Surgery (n\u0026thinsp;=\u0026thinsp;455), it showed that TAVI is superior to surgery among patients aged\u0026thinsp;\u0026gt;\u0026thinsp;70 years [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. TAVR is now recommended for longer life expectancy patients with TAVR [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eTAVR in women\u003c/h3\u003e\n\u003cp\u003eMen and women have a similar prevalence of valvular disease [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Women undergo SAVR for AS less frequently than men and have worse outcomes with SAVR than men [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] SAVR in women has been correlated with worse in-hospital mortality and higher cost compared with men [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Numerous studies had reported mortality benefits for women with TAVR. A study by Siontis et al.22, for 2-year mortality - TAVR showed a 13% relative risk reduction compared to SAVR. This was observed to be more beneficial for females undergoing a transfemoral approach [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. In another Panoulas et al1 study of gender‐specific survival combining 4 randomized controlled trials of TAVR vs SAVR with a total of 3758 patients (female: 1706, male 2052), women had significantly lower mortality than male 1 and 2 years with a reduction of 31% at 1 year and 26% at 2 years. The difference in treatment was statistically significant with p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eTAVR over age 90\u003c/h2\u003e \u003cp\u003eTAVR can be performed in nonagenarians with high procedural success rates and acceptable in-hospital, 30‐day, and 1‐year mortality rates. Most studies for patients above age 90 show a procedural success rate greater than 95% and an absolute stroke rate of less than 4%, with no effect modification by age. In a study by Sun et al, there is a similar rate of major bleeding in patients above and below 90 years, with a relative risk of 1.17 (95% CI 1.04\u0026ndash;1.32) [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. In contrast, if the nonfemoral access techniques were used the rate of vascular complication was increased for patients above 90 years. From the FRAILTY‐AVR study, nonfemoral access had higher 30‐day mortality in frail patients (odds ratio 3.91, 95% CI 1.48\u0026ndash;10.31) [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Most studies show higher risk in nonfemoral access though the comparison of femoral and nonfemoral access routes is clearly not randomized but favors femoral access TAVR in older patients [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eOn average, patients above 90 years can tolerate the TAVR procedure quite well, with low in-hospital mortality and low adverse effects. This subgroup of patients is under‐represented or at the very least highly selected in randomized trials, Age alone is inadequate to stratify patients, there must be deeper evaluations for frailty such as that offered by a comprehensive geriatric assessment. Finally, the process of mutual decision‐making is predominant to make sure that the course of action is patient‐centered and considers the anticipated risks and benefits with the nonagenarian's preferences and principles [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eDelirium After TAVR\u003c/h3\u003e\n\u003cp\u003eThe development of TAVR has made an increased number of the elderly patient population with high comorbidities and frailty eligible for treatment compared to the pre-TAVR [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Post-procedure is a frequent complication with disturbance in consciousness, cognition, and attention. The rate of delirium varies from 2\u0026ndash;4% [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. The incidence of delirium yearly in the general population is anticipated at 1\u0026ndash;2%, this number increases with age and can be up to 14% in elderly patients (age\u0026thinsp;\u0026gt;\u0026thinsp;85) [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. In hospital admissions, delirium is noted in 14\u0026ndash;24% [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. The pooled incidences of delirium after cardiac surgery is noted to be 8\u0026ndash;20% [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e][\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. For TAVR the pooled incidence of delirium is 8\u0026ndash;23% [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAs TAVR is rapidly advancing there is improving awareness of delirium for preventive and therapeutic options [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Delirium has been related to impaired recovery, increased length of hospital stays, high cost for index hospitalization, increased risk of readmissions within 6 months, and mortality [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. Treatment for delirium is established mainly on nonpharmacological strategies identifying and eliminating the trigger factors such as pain and infection, and optimization of environmental factors. TAVR-associated delirium can be avoided by addressing the predisposing and precipitating factors. In different hospital settings, interventions that reduced the incidence of delirium resulted in improved clinical outcomes and reduced costs [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e].\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eProcedural improvements\u003c/h2\u003e \u003cp\u003eWith the continuous development of TAVR, many advancements have been implemented in various procedures to improve outcomes and decrease the procedure burden. The primary goals of the procedure are to perform under local anesthesia and percutaneously [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Preventing general anesthesia during the procedure can have improved outcomes and reduced length of in-hospital stay [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. This approach, however, excludes the standard use of transesophageal echocardiography (TEE). Monitoring of post-procedural aortic regurgitation with advanced TEE or non-imaging methods is needed [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. The promotion of early mobilization can be achieved by using balloon-expandable sheaths and totally percutaneous TF-TAVR with advanced vascular closure devices [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eCost-effectiveness\u003c/h2\u003e \u003cp\u003eApart from clinical outcomes, the price of the procedure is an important factor when choosing a treatment modality, notably in low healthcare-budget countries [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. SAVR is associated with high predicted risk, and high costs when stratified by surgical risk category [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. The benefits of TAVR come at a cost-effectively adequate cost in the higher-risk groups, but this may not apply to low-risk patients [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. Ultimately, the anticipated variations in the cost of TAVR prostheses can be an important influencer of cost-efficacy when comparing TAVR and SAVR [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eTAVR is a growing procedure with constant advancements in methods, selection of patients, and utilization of resources and devices. The outcomes have mostly been reliable and progressed since the launch of this procedure. However, there is room to decrease complications and enhance outcomes, which drives innovation in this area. In a very short time, there is a lot of tremendous evidence accumulated for TAVR as the patient population that benefits from this procedure continues to increase with time. As there is an upward trend in the preference for TAVR, there is also a trend toward improving the technology and techniques.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eAcknowledgements: None\u003c/p\u003e\n\u003cp\u003eInstitutional Review Board Approval: Not needed as the data has been collected from public databases.\u003c/p\u003e\n\u003cp\u003eEthics approval and consent to participate: Not applicable.\u003c/p\u003e\n\u003cp\u003eConsent for publication: Not applicable.\u003c/p\u003e\n\u003cp\u003eAvailability of data and material: Data has been collected from PubMed, Crossref and Google Scholar\u003c/p\u003e\n\u003cp\u003eConflict of interests: The authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003eFinancial Disclosures/Funding: Not applicable.\u003c/p\u003e\n\u003cp\u003eInformed Consent: Not applicable\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Authors' contributions: Silpa Choday as the first author analyzed and interpreted the data, wrote most of the sections, and was a major contributor to writing the manuscript. Aubin as a second author analyzed the sections and was a contributor to the few parts of the manuscript. Austin as a third author collected relevant articles and contributed to a few sections of the article. Ali as a senior author reviewed the article and made necessary changes to the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eArora S, Misenheimer JA, Ramaraj R. Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status. Tex Heart Inst J. 2017 Feb 1;44(1):29-38. doi: 10.14503/THIJ-16-5852. Erratum in: Tex Heart Inst J. 2018 Apr 7;45(2):122. PMID: 28265210; PMCID: PMC5317356.\u003c/li\u003e\n \u003cli\u003eSiontis GCM, Overtchouk P, Cahill TJ, Modine T, Prendergast B, Praz F, Pilgrim T, Petrinic T, Nikolakopoulou A, Salanti G, S\u0026oslash;ndergaard L, Verma S, J\u0026uuml;ni P, Windecker S. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis. Eur Heart J. 2019 Oct 7;40(38):3143-3153. doi: 10.1093/eurheartj/ehz275. PMID: 31329852.\u003c/li\u003e\n \u003cli\u003eKodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686\u0026ndash;1695\u003c/li\u003e\n \u003cli\u003eMack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson MJ, Svensson LG; PARTNER 1 trial Investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015;385:2477\u0026ndash;2484.\u003c/li\u003e\n \u003cli\u003eAdams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790\u0026ndash;1798\u003c/li\u003e\n \u003cli\u003eUK TAVI Trial Investigators; Toff WD, Hildick-Smith D, Kovac J, Mullen MJ, Wendler O, Mansouri A, Rombach I, Abrams KR, Conroy SP, Flather MD, Gray AM, MacCarthy P, Monaghan MJ, Prendergast B, Ray S, Young CP, Crossman DC, Cleland JGF, de Belder MA, Ludman PF, Jones S, Densem CG, Tsui S, Kuduvalli M, Mills JD, Banning AP, Sayeed R, Hasan R, Fraser DGW, Trivedi U, Davies SW, Duncan A, Curzen N, Ohri SK, Malkin CJ, Kaul P, Muir DF, Owens WA, Uren NG, Pessotto R, Kennon S, Awad WI, Khogali SS, Matuszewski M, Edwards RJ, Ramesh BC, Dalby M, Raja SG, Mariscalco G, Lloyd C, Cox ID, Redwood SR, Gunning MG, Ridley PD. Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1875-1887. doi: 10.1001/jama.2022.5776. PMID: 35579641; PMCID: PMC9115619.\u003c/li\u003e\n \u003cli\u003eKumar V, Sandhu GS, Harper CM, Ting HH, Rihal CS. Transcatheter Aortic Valve Replacement Programs: Clinical Outcomes and Developments. J Am Heart Assoc. 2020 Apr 21;9(8):e015921. doi: 10.1161/JAHA.120.015921. Epub 2020 Apr 17. PMID: 32301367; PMCID: PMC7428521.\u003c/li\u003e\n \u003cli\u003eBlock PC, Palacios IF. Clinical and hemodynamic follow‐up after percutaneous aortic valvuloplasty in the elderly. Am J Cardiol. 1988;62:760\u0026ndash;763. [PubMed] [Google Scholar]\u003c/li\u003e\n \u003cli\u003eYerasi C, Rogers T, Forrestal BJ, Case BC, Khan JM, Ben-Dor I, Satler LF, Garcia-Garcia HM, Cohen JE, Kitahara H, Shults C, Waksman R. Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-Risk Patients With Severe Aortic Stenosis. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1169-1180. doi: 10.1016/j.jcin.2021.03.058. PMID: 34112453.\u003c/li\u003e\n \u003cli\u003eAfilalo J, Lauck S, Kim DH, Lef\u0026egrave;vre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, G\u0026eacute;n\u0026eacute;reux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7. PMID: 28693934.\u003c/li\u003e\n \u003cli\u003eHolmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O\u0026apos;Brien SM, Vemulapalli S, Edwards FH, Carroll J, Shahian D, Grover F, Tuzcu EM, Peterson ED, Brindis RG, Mack MJ; STS/ACC TVT Registry. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015 Mar 10;313(10):1019-28. doi: 10.1001/jama.2015.1474. PMID: 25756438.\u003c/li\u003e\n \u003cli\u003eGarcia S, Cubeddu RJ, Hahn RT, Ternacle J, Kapadia SR, Kodali SK, Thourani VH, Jaber WA, Asher CR, Elmariah S, Makkar R, Webb JG, Herrmann HC, Lu M, Devireddy CM, Malaisrie SC, Smith CR, Mack MJ, Sorajja P, Cavalcante JL, Goessl M, Shroff GR, Leon MB, Pibarot P. 5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease. JACC Cardiovasc Interv. 2021 Sep 27;14(18):1995-2005. doi: 10.1016/j.jcin.2021.07.004. PMID: 34556273.\u003c/li\u003e\n \u003cli\u003eS\u0026oslash;ndergaard L, Ihlemann N, Capodanno D, J\u0026oslash;rgensen TH, Nissen H, Kjeldsen BJ, Chang Y, Steinbr\u0026uuml;chel DA, Olsen PS, Petronio AS, Thyregod HGH. Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk. J Am Coll Cardiol. 2019 Feb 12;73(5):546-553. doi: 10.1016/j.jacc.2018.10.083. PMID: 30732707.\u003c/li\u003e\n \u003cli\u003eSannino A, Schiattarella GG, Toscano E, Gargiulo G, Giugliano G, Galderisi M, Losi MA, Stabile E, Cirillo P, Imbriaco M, Grayburn PA, Trimarco B, Esposito G. Meta-Analysis of Effect of Body Mass Index on Outcomes After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2017 Jan 15;119(2):308-316. doi: 10.1016/j.amjcard.2016.09.031. Epub 2016 Oct 7. PMID: 27839771.\u003c/li\u003e\n \u003cli\u003eJ\u0026oslash;rgensen TH, Thyregod HGH, Ihlemann N, Nissen H, Petursson P, Kjeldsen BJ, Steinbr\u0026uuml;chel DA, Olsen PS, S\u0026oslash;ndergaard L. Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur Heart J. 2021 Aug 7;42(30):2912-2919. doi: 10.1093/eurheartj/ehab375.\u003c/li\u003e\n \u003cli\u003eSondergaard L. Transcatheter aortic valve implantation in patients with longer life expectancy: what measures are needed? Eur Heart J 2019;40:1331\u0026ndash;1333. [PubMed] [Google Scholar].\u003c/li\u003e\n \u003cli\u003ePanoulas VF, Francis DP, Ruparelia N, et al. Female‐specific survival advantage from transcatheter aortic valve implantation over surgical aortic valve replacement: meta‐analysis of the gender subgroups of randomised controlled trials including 3758 patients. Int J Cardiol. 2018;250:66\u0026ndash;72. [PubMed] [Google Scholar]\u003c/li\u003e\n \u003cli\u003eChaker Z, Badhwar V, Alqahtani F, et al. Sex differences in the utilization and outcomes of surgical aortic valve replacement for severe aortic stenosis. J Am Heart Assoc. 2017;6:pii:e006370. [PMC free article] [PubMed] [Google Scholar]\u003c/li\u003e\n \u003cli\u003eSiontis GC, Praz F, Pilgrim T, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta‐analysis of randomized trials. Eur Heart J. 2016;37:3503\u0026ndash;3512. [PubMed] [Google Scholar].\u003c/li\u003e\n \u003cli\u003eSun Y, Liu X, Chen Z, et al. Meta‐analysis of predictors of early severe bleeding in patients who underwent transcatheter aortic valve implantation. Am J Cardiol. 2017;120(4):655‐661. [PubMed] [Google Scholar]\u003c/li\u003e\n \u003cli\u003eDrudi LM, Ades M, Asgar A, et al. Interaction between frailty and access site in older adults undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2018;11(21):2185‐2192. [PubMed] [Google Scholar]\u003c/li\u003e\n \u003cli\u003eGalatas C, Afilalo J. Transcatheter aortic valve replacement over age 90: Risks vs benefits. Clin Cardiol. 2020 Feb;43(2):156-162. doi: 10.1002/clc.23310. Epub 2019 Dec 16. PMID: 31840834; PMCID: PMC7021650.\u003c/li\u003e\n \u003cli\u003eA.P. Durko, R.L. Osnabrugge, N.M. Van Mieghem, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections Eur Heart J, 39 (2018), pp. 2635-2642\u003c/li\u003e\n \u003cli\u003eA. Soundhar, R. Udesh, A. Mehta, et al. Delirium following transcatheter aortic valve replacement: National Inpatient Sample analysis J Cardiothorac Vasc Anesth, 31 (2017), pp. 1977-1984\u003c/li\u003e\n \u003cli\u003eS.K. Inouye, R.G. Westendorp, J.S. Saczynski Delirium in elderly people Lancet, 383 (2014), pp. 911-922\u003c/li\u003e\n \u003cli\u003eJ.L. Rudolph, E.R. Marcantonio Review articles: postoperative delirium: acute change with long-term implications Anesth Analg, 112 (2011), pp. 1202-1211\u003c/li\u003e\n \u003cli\u003eE. Crocker, T. Beggs, A. Hassan, et al. Long-term effects of postoperative delirium in patients undergoing cardiac operation: a systematic review Ann Thorac Surg, 102 (2016), pp. 1391-1399\u003c/li\u003e\n \u003cli\u003eE. Tilley, P.J. Psaltis, T. Loetscher, et al. Meta-analysis of prevalence and risk factors for delirium after transcatheter aortic valve implantation 29.M. Abawi, M. Pagnesi, P. Agostoni, et al.\u003c/li\u003e\n \u003cli\u003ePostoperative delirium in individuals undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis J Am Geriatr Soc, 66 (2018), pp. 2417-2424\u003c/li\u003e\n \u003cli\u003eK. Ibrahim, C.P. McCarthy, K.J. McCarthy, et al. Delirium in the cardiac intensive care unit J Am Heart Assoc, 7 (2018), Article e008568\u003c/li\u003e\n \u003cli\u003eB.J. Potter, C. Thompson, P. Green, S. Clancy Incremental cost and length of stay associated with postprocedure delirium in transcatheter and surgical aortic valve replacement patients in the United States Catheter Cardiovasc Interv, 93 (2019), pp. 1132-1136\u003c/li\u003e\n \u003cli\u003eF.C. Bakker, A. Persoon, S.J.H. Bredie, et al. The CareWell in Hospital program to improve the quality of care for frail elderly inpatients: results of a before-after study with focus on surgical patients Am J Surg, 208 (2014), pp. 735-746.\u003c/li\u003e\n \u003cli\u003eDurko AP, Osnabrugge RL, Kappetein AP. Long-term outlook for transcatheter aortic valve replacement. Trends Cardiovasc Med. 2018 Apr;28(3):174-183. doi: 10.1016/j.tcm.2017.08.004. Epub 2017 Aug 10. PMID: 28838702.\u003c/li\u003e\n \u003cli\u003eG.M. Fr\u0026ouml;hlich, A.J. Lansky, J. Webb, M. Roffi, S. Toggweiler, M. Reinthaler, et al. Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)\u0026ndash;\u0026ndash;systematic review and meta-analysis BMC Med, 12 (2014), p. 41\u003c/li\u003e\n \u003cli\u003eE. Van Belle, A. Rauch, F. Vincent, E. Robin, M. Kibler, J. Labreuche, et al. Von Willebrand factor multimers during transcatheter aortic-valve replacement N Engl J Med, 375 (2016), pp. 335-344.\u003c/li\u003e\n \u003cli\u003eR.L.J. Osnabrugge, A.M. Speir, S.J. Head, C.E. Fonner, E. Fonner Jr, G. Ailawadi, et al. Costs for surgical aortic valve replacement according to preoperative risk categories Ann Thorac Surg, 96 (2013), pp. 500-506\u003c/li\u003e\n \u003cli\u003eM.R. Reynolds, S.J. Baron, D.J. Cohen Economic implications of transcatheter aortic valve replacement in patients at intermediate surgical risk Circulation, 134 (2016), p. 1416, 10.1161/CIRCULATIONAHA.116.021962\u003c/li\u003e\n \u003cli\u003eG. Ailawadi, D.J. LaPar, A.M. Speir, R.K. Ghanta, L.T. Yarboro, I.K. Crosby, et al. Contemporary costs associated with transcatheter aortic valve replacement: a propensity-matched cost analysis Ann Thorac Surg, 101 (2016), pp. 154-161\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"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":"Aortic stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, safety, efficacy","lastPublishedDoi":"10.21203/rs.3.rs-4736484/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4736484/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eTranscatheter aortic valve implantation (TAVI) has emerged as a transformative innovation in cardiovascular surgery, offering a minimally invasive alternative to conventional open-heart surgery for patients with severe aortic stenosis. It is initially introduced as a treatment option for high-risk surgical candidates, TAVI has progressively expanded its indications to encompass intermediate and even low-risk patients, supported by robust clinical trials demonstrating comparable or superior outcomes to surgical aortic valve replacement. The procedural safety of TAVI has significantly improved with advancements in device technology, procedural techniques, and operator experience, leading to lower rates of procedural complications such as stroke, vascular injury, and paravalvular leak. Furthermore, the long-term effectiveness of TAVI is underscored by favorable outcomes in terms of symptom relief, functional improvement, and overall survival. This review discussed the current evidence on the safety and outcomes of TAVI, emphasizing its role in reshaping cardiovascular surgery paradigms and expanding treatment options for patients deemed high-risk or unsuitable for traditional surgery. As ongoing research continues to refine patient selection criteria, optimize procedural techniques, and enhance postoperative management, TAVI stands poised to further enhance cardiovascular care and outcomes in the foreseeable future.\u003c/p\u003e","manuscriptTitle":"Innovations in Cardiovascular Surgery: Safety and Outcomes of Transcatheter Aortic Valve Implantation","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-16 08:29:02","doi":"10.21203/rs.3.rs-4736484/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","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}}],"origin":"","ownerIdentity":"1dc9c9e1-0745-493f-984c-d64e4a6ad9d0","owner":[],"postedDate":"July 16th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-07-16T08:29:03+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-16 08:29:02","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4736484","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4736484","identity":"rs-4736484","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}