How TAVI Registries Report Clinical Outcomes-A Systematic Review of Endpoints Based on VARC-2 Definitions

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2017 Sep 15

PMID 28910289

Citations 10

Authors

Shixuan Zhang

Peter L Kolominsky-Rabas

Affiliations

Soon will be listed here.

Abstract

Introduction: Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical risk. Since its first human implantation by Cribier et al., TAVI has been shown to increase survival rate and quality of life for high surgical risks patients. The objective of this study is to provide an overview of TAVI registries and the reporting clinical outcomes based on the VARC-2 definitions. In addition, the comparability and adherence of VARC-2 reporting within the identified TAVI registries was reviewed.

Materials And Methods: A systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients' characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry's publications.

Results: This review identified 466 studies that were potentially relevant, and 20 TAVI registries reported VARC-2 definitions involved in our present review. Of all 20 registries, an overall sample size of 12,583 patients was involved. The 30-day all-cause mortality ranged from 0 to 12.7%. From 20 registries, 14 registries reported the cardiovascular mortality at 30 days. 9 registries reported myocardial infarction (MI) rate based on VARC-2 definitions, and 7 registries reported peri-procedural MI rate (<72h). In our review, most of registries presented MI rates ranging from 0.5% to 2%. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation.

Conclusion: Since the introduction of VARC definitions from 2011, VARC and VARC-2 definitions are still not systematically used by all TAVI studies. These endpoint definitions warrant a concise and systemic analysis of outcome measures. Reporting TAVI-outcome uniformly makes study result comparison feasible. This definitely will increase patient safety, additionally to provide sufficient evidence to support decision makers like regulatory bodies, HTA agencies, payers.

Citing Articles

Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart).

Aktaa S, Batra G, James S, Blackman D, Ludman P, Mamas M Eur Heart J Qual Care Clin Outcomes. 2022; 9(5):529-536.

PMID: 36195332 PMC: 10405164. DOI: 10.1093/ehjqcco/qcac063.

Outcome of transcatheter aortic valve replacement in patients over 85 years of age versus patients aged 85 and younger.

van den Brink F, Wijtsma I, Amrane H, Vossenberg T, Haenen J, Porta F Neth Heart J. 2022; 30(10):473-478.

PMID: 35608812 PMC: 9474752. DOI: 10.1007/s12471-022-01693-9.

OS-LALM-OGM Algorithm-Based Computed Tomography Image for Characteristics and Comorbidities of Patients before Transcatheter Aortic Valve Implantation.

Sun W, He J, Tan X, Wang Y, Chen F, Xu D J Healthc Eng. 2021; 2021:3631208.

PMID: 34804448 PMC: 8601807. DOI: 10.1155/2021/3631208.

Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study.

Nardi G, De Backer O, Saia F, Sondergaard L, Ristalli F, Meucci F EuroIntervention. 2021; 17(17):e1397-e1406.

PMID: 34734559 PMC: 9896402. DOI: 10.4244/EIJ-D-21-00581.

Characteristics and Quality of National Cardiac Registries: A Systematic Review.

Dawson L, Biswas S, Lefkovits J, Stub D, Burchill L, Evans S Circ Cardiovasc Qual Outcomes. 2021; 14(9):e007963.

PMID: 34517724 PMC: 8452241. DOI: 10.1161/CIRCOUTCOMES.121.007963.

References

Walther T, Kempfert J . Transapical vs. transfemoral aortic valve implantation: Which approach for which patient, from a surgeon's standpoint. Ann Cardiothorac Surg. 2013; 1(2):216-9. PMC: 3741736. DOI: 10.3978/j.issn.2225-319X.2012.07.10. View

Walther T, Kasimir M, Doss M, Schuler G, Simon P, Schachinger V . One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation. Eur J Cardiothorac Surg. 2010; 39(4):532-7. DOI: 10.1016/j.ejcts.2010.06.002. View

Inohara T, Hayashida K, Watanabe Y, Yamamoto M, Takagi K, Yashima F . Streamlining the learning process for TAVI: Insight from a comparative analysis of the OCEAN-TAVI and the massy registries. Catheter Cardiovasc Interv. 2015; 87(5):963-70. DOI: 10.1002/ccd.26266. View

Siemieniuk R, Agoritsas T, Manja V, Devji T, Chang Y, Bala M . Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis. BMJ. 2016; 354:i5130. PMC: 5040923. DOI: 10.1136/bmj.i5130. View

Genereux P, Head S, Van Mieghem N, Kodali S, Kirtane A, Xu K . Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol. 2012; 59(25):2317-26. DOI: 10.1016/j.jacc.2012.02.022. View

Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H . Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010; 122(1):62-9. DOI: 10.1161/CIRCULATIONAHA.109.907402. View

De Backer O, Gotberg M, Ihlberg L, Packer E, Savontaus M, Nielsen N . Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry. Int J Cardiol. 2016; 219:92-7. DOI: 10.1016/j.ijcard.2016.05.072. View

Mylotte D, Osnabrugge R, Windecker S, Lefevre T, de Jaegere P, Jeger R . Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013; 62(3):210-219. DOI: 10.1016/j.jacc.2013.03.074. View

Smith C, Leon M, Mack M, Miller D, Moses J, Svensson L . Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23):2187-98. DOI: 10.1056/NEJMoa1103510. View

10.

Petronio A, Giannini C, De Carlo M, Bedogni F, Colombo A, Tamburino C . Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry. EuroIntervention. 2015; 12(3):381-8. DOI: 10.4244/EIJY15M03_05. View

11.

Binder R, Stortecky S, Heg D, Tueller D, Jeger R, Toggweiler S . Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves. Circ Cardiovasc Interv. 2015; 8(10). DOI: 10.1161/CIRCINTERVENTIONS.115.002653. View

12.

Salizzoni S, DOnofrio A, Agrifoglio M, Colombo A, Chieffo A, Cioni M . Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER). Eur J Cardiothorac Surg. 2016; 50(6):1139-1148. DOI: 10.1093/ejcts/ezw218. View

13.

Chieffo A, Van Mieghem N, Tchetche D, Dumonteil N, Giustino G, van der Boon R . Impact of Mixed Aortic Valve Stenosis on VARC-2 Outcomes and Postprocedural Aortic Regurgitation in Patients Undergoing Transcatheter Aortic Valve Implantation: Results From the International Multicentric Study PRAGMATIC (Pooled.... Catheter Cardiovasc Interv. 2015; 86(5):875-85. DOI: 10.1002/ccd.25975. View

14.

Czarny M, Resar J . Diagnosis and management of valvular aortic stenosis. Clin Med Insights Cardiol. 2014; 8(Suppl 1):15-24. PMC: 4213201. DOI: 10.4137/CMC.S15716. View

15.

Abdel-Wahab M, Zahn R, Gerckens U, Linke A, Sievert H, Schafer U . Predictors of 1-year mortality in patients with aortic regurgitation after transcatheter aortic valve implantation: an analysis from the multicentre German TAVI registry. Heart. 2014; 100(16):1250-6. DOI: 10.1136/heartjnl-2013-305385. View

16.

Walters D, Sinhal A, Baron D, Pasupati S, Thambar S, Yong G . Initial experience with the balloon expandable Edwards-SAPIEN Transcatheter Heart Valve in Australia and New Zealand: the SOURCE ANZ registry: outcomes at 30 days and one year. Int J Cardiol. 2013; 170(3):406-12. DOI: 10.1016/j.ijcard.2013.11.027. View

17.

Lefevre T, Colombo A, Tchetche D, Latib A, Klugmann S, Fajadet J . Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic.... JACC Cardiovasc Interv. 2016; 9(1):68-75. DOI: 10.1016/j.jcin.2015.09.027. View

18.

Van Mieghem N, Dumonteil N, Chieffo A, Roux Y, van der Boon R, Giustino G . Current decision making and short-term outcome in patients with degenerative aortic stenosis: the Pooled-RotterdAm-Milano-Toulouse In Collaboration Aortic Stenosis survey. EuroIntervention. 2016; 11(11):e1305-13. DOI: 10.4244/EIJV11I10A253. View

19.

Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F . Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002; 106(24):3006-8. DOI: 10.1161/01.cir.0000047200.36165.b8. View

20.

B Ribeiro H, Nombela-Franco L, Munoz-Garcia A, Lemos P, Amat-Santos I, Serra V . Predictors and impact of myocardial injury after transcatheter aortic valve replacement: a multicenter registry. J Am Coll Cardiol. 2015; 66(19):2075-2088. DOI: 10.1016/j.jacc.2015.08.881. View