Abstract
With a rapidly aging society, the number of patients with cardiovascular disease—in particular aortic stenosis—is progressively increasing. Although conventional aortic valve replacement remains the only treatment known to improve prognosis and symptoms in symptomatic patients with aortic stenosis, about one-third are still withhold from the life-saving therapy. Based on the compelling evidence of the randomized Placement of Aortic transcatheter valves (PARTNER) A and B cohort, TAVI is now considered standard of care for extreme risk and inoperable patients and is an alternative to surgery for high-risk patients with symptomatic aortic stenosis. However, these patients were super-selected, which does not reflect a clinical real-world situation. TAVI registries represent a real-world scenario, and therefore provide the evidence for the treatment of high-risk patients (regarding comorbidities and anatomical factors) in daily clinical life. The review will focus on the recently published Edwards SAPIEN, Medtronic CoreValve and mixed (national) registries with the focus on short- and midterm outcome. These registries suggest that the growing experience of the operators with regard to patient selection, prevention, recognition and treatment of procedural complications together with the developments in valve design will improve the short-term results of TAVI. However, randomized trials in intermediate risk patients and data on long-term valve durability are a prerequisite before indications can be expanded to younger and lower risk patient population.
Similar content being viewed by others
References
Woitek FJ, linke A (2012) Aortic valve stenosis: matching the approach to the patient. Dtsch Med Wochenschr 137:648–651. doi:10.1055/s-0031-1298990
Ross J, Braunwald E (1968) Aortic stenosis. Circulation 38:61–67
Iung B, Cachier A, Baron G et al (2005) Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 26:2714–2720. doi:10.1093/eurheartj/ehi471
Bach DS, Siao D, Girard SE et al (2009) Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes 2:533–539. doi:10.1161/CIRCOUTCOMES.109.848259
Cribier A, Eltchaninoff H, Bash A et al (2002) Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106:3006–3008
Bosmans JM, Kefer J, De Bruyne B et al (2011) Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: results of the Belgian national registry. Interact Cardiovasc Thorac Surg 12:762–767. doi:10.1510/icvts.2010.253773
Buellesfeld L, Gerckens U, Schuler G et al (2011) 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol 57:1650–1657. doi:10.1016/j.jacc.2010.11.044
Cribier A, Eltchaninoff H, Tron C et al (2006) Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol 47:1214–1223. doi:10.1016/j.jacc.2006.01.049
D’Onofrio A, Rubino P, Fusari M et al (2011) Clinical and hemodynamic outcomes of “all-comers” undergoing transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). J Thorac Cardiovasc Surg 142:768–775. doi:10.1016/j.jtcvs.2011.06.026
Eltchaninoff H, Prat A, Gilard M et al (2011) Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J 32:191–197. doi:10.1093/eurheartj/ehq261
Grube E, Laborde JC, Gerckens U et al (2006) Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation 114:1616–1624. doi:10.1161/CIRCULATIONAHA.106.639450
Grube E, Schuler G, Buellesfeld L et al (2007) Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol 50:69–76. doi:10.1016/j.jacc.2007.04.047
Himbert D, Descoutures F, Al-Attar N et al (2009) Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis. J Am Coll Cardiol 54:303–311. doi:10.1016/j.jacc.2009.04.032
Lefevre T, Kappetein AP, Wolner E et al (2011) One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J 32:148–157. doi:10.1093/eurheartj/ehq427
Petronio AS, De Carlo M, Bedogni F et al (2010) Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circ Cardiovasc Interv 3:359–366. doi:10.1161/CIRCINTERVENTIONS.109.930453
Piazza N, Grube E, Gerckens U et al (2008) Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. EuroIntervention 4:242–249
Rodés-Cabau J, Webb JG, Cheung A et al (2010) Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol 55:1080–1090. doi:10.1016/j.jacc.2009.12.014
Tamburino C, Capodanno D, Ramondo A et al (2011) Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 123:299–308. doi:10.1161/CIRCULATIONAHA.110.946533
Thomas M, Schymik G, Walther T et al (2011) One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 124:425–433. doi:10.1161/CIRCULATIONAHA.110.001545
Thomas M, Schymik G, Walther T et al (2010) 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 122:62–69. doi:10.1161/CIRCULATIONAHA.109.907402
Webb JG, Chandavimol M, Thompson CR et al (2006) Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation 113:842–850. doi:10.1161/CIRCULATIONAHA.105.582882
Svensson LG, Dewey T, Kapadia S et al (2008) United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex. Ann Thorac Surg 86:46–54. doi:10.1016/j.athoracsur.2008.04.049 discussion 54–5
Walther T, Kasimir M-T, Doss M et al (2011) One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation. Eur J Cardiothorac Surg 39:532–537. doi:10.1016/j.ejcts.2010.06.002
Beller CJ, Schmack B, Seppelt P et al (2013) The groin first approach for transcatheter aortic valve implantation: are we pushing the limits for transapical implantation? Clin Res Cardiol 102:111–117. doi:10.1007/s00392-012-0502-9
Blumenstein J, Van Linden A, Kim WK et al (2013) Early SAPIEN transcatheter heart valve dysfunction due to tissue ingrowth in an octogenarian. Clin Res Cardiol 102:237–240. doi:10.1007/s00392-012-0518-1
Blumenstein J, Van Linden A, Kempfert J et al (2012) Retrograde, transsubclavian implantation of a SAPIEN XT™ aortic valve prosthesis with the Edwards NovaFlex+™ system. Clin Res Cardiol 101:773–775. doi:10.1007/s00392-012-0460-2
Leon MB, Smith CR, Mack M et al (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:1597–1607. doi:10.1056/NEJMoa1008232
Smith CR, Leon MB, Mack MJ et al (2011) Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364:2187–2198. doi:10.1056/NEJMoa1103510
Chorianopoulos E, Krumsdorf U, Pleger ST et al (2012) Incidence of late occurring bradyarrhythmias after TAVI with the self-expanding CoreValve® aortic bioprosthesis. Clin Res Cardiol 101:349–355. doi:10.1007/s00392-011-0398-9
Chorianopoulos E, Krumsdorf U, Geis N et al (2014) Preserved prognostic value of preinterventional troponin T levels despite successful TAVI in patients with severe aortic stenosis. Clin Res Cardiol 103:65–72. doi:10.1007/s00392-013-0624-8
Conradi L, Seiffert M, Franzen O et al (2011) First experience with transcatheter aortic valve implantation and concomitant percutaneous coronary intervention. Clin Res Cardiol 100:311–316. doi:10.1007/s00392-010-0243-6
Dimitriadis Z, Wiemer M, Scholtz W et al (2013) Sleep-disordered breathing in patients undergoing transfemoral aortic valve implantation for severe aortic stenosis. Clin Res Cardiol 102:895–903. doi:10.1007/s00392-013-0603-0
Gotzmann M, Mügge A (2011) Fatal prosthetic valve endocarditis of the CoreValve ReValving System. Clin Res Cardiol 100:715–717. doi:10.1007/s00392-011-0315-2
Greif M, Lange P, Mair H et al (2012) Transcatheter Edwards Sapien XT valve in valve implantation in degenerated aortic bioprostheses via transfemoral access. Clin Res Cardiol 101:993–1001. doi:10.1007/s00392-012-0488-3
Koene BM, Soliman Hamad MA, Bouma W et al (2013) Can postoperative mean transprosthetic pressure gradient predict survival after aortic valve replacement? Clin Res Cardiol. doi:10.1007/s00392-013-0629-3
Motloch LJ, Rottlaender D, Reda S et al (2012) Local versus general anesthesia for transfemoral aortic valve implantation. Clin Res Cardiol 101:45–53. doi:10.1007/s00392-011-0362-8
Muensterer A, Mazzitelli D, Ruge H et al (2013) Safety and efficacy of the subclavian access route for TAVI in cases of missing transfemoral access. Clin Res Cardiol 102:627–636. doi:10.1007/s00392-013-0575-0
Vavuranakis M, Vrachatis DA, Boudoulas H et al (2012) Effect of transcatheter aortic valve implantation on the ascending aorta’s elasticity. Clin Res Cardiol 101:895–899. doi:10.1007/s00392-012-0473-x
Zahn R, Schiele R, Zeymer U et al (2013) Occlusion of the left main stem: a rare, but life-threatening complication of transcatheter aortic valve implantation with the Medtronic CoreValve™ prosthesis. Clin Res Cardiol 102:323–326. doi:10.1007/s00392-013-0538-5
Zuern CS, Eick C, Rizas K et al (2012) Prognostic value of mild-to-moderate pulmonary hypertension in patients with severe aortic valve stenosis undergoing aortic valve replacement. Clin Res Cardiol 101:81–88. doi:10.1007/s00392-011-0367-3
Ewert P, Horlick E, Berger F (2011) First implantation of the CE-marked transcatheter Sapien pulmonic valve in Europe. Clin Res Cardiol 100:85–87. doi:10.1007/s00392-010-0214-y
Haas NA, Moysich A, Neudorf U et al (2013) Percutaneous implantation of the Edwards SAPIEN™ pulmonic valve: initial results in the first 22 patients. Clin Res Cardiol 102:119–128. doi:10.1007/s00392-012-0503-8
Kempfert J, Möllmann H, Walther T (2012) Symetis ACURATE TA valve. EuroIntervention 8(Suppl Q):Q102–Q109. doi:10.4244/EIJV8SQA19
Treede H, Rastan A, Ferrari M et al (2012) JenaValve. EuroIntervention 8(Suppl Q):Q88–Q93. doi:10.4244/EIJV8SQA16
Falk V, Walther T, Schwammenthal E et al (2011) Transapical aortic valve implantation with a self-expanding anatomically oriented valve. Eur Heart J 32:878–887. doi:10.1093/eurheartj/ehq445
Manoharan G, Spence MS, Rodés-Cabau J, Webb JG (2012) St Jude Medical Portico valve. EuroIntervention 8(Suppl Q):Q97–Q101. doi:10.4244/EIJV8SQA18
Bijuklic K, Tübler T, Low RI et al (2012) Direct Flow Medical valve. EuroIntervention 8(Suppl Q):Q75–Q80. doi:10.4244/EIJV8SQA13
Kodali SK, O’Neill WW, Moses JW et al (2011) Early and late (one year) outcomes following transcatheter aortic valve implantation in patients with severe aortic stenosis (from the United States REVIVAL trial). Am J Cardiol 107:1058–1064. doi:10.1016/j.amjcard.2010.11.034
Leon MB, Piazza N, Nikolsky E et al (2011) Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol 57(3):253–269
Kappetein AP, Head SJ, Généreux P et al (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. JAC 60:1438–1454. doi:10.1016/j.jacc.2012.09.001
Wendler O, Walther T, Schroefel H et al (2011) The SOURCE Registry: what is the learning curve in trans-apical aortic valve implantation? Eur J Cardio-Thoracic Surg 39:853–859. doi:10.1016/j.ejcts.2010.11.018 discussion 859–860
Wendler O Transapical versus transfemoral TAVI: real-world data (SOURCE XT registry)-2012-Lectures-PCRonline. In: pcronline.com. http://www.pcronline.com/Lectures/2012/Transapical-versus-transfemoral-TAVI-real-world-data-SOURCE-XT-registry. Accessed 15 Jan 2014
Ussia GP, Barbanti M, Petronio AS et al (2012) Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J 33:969–976. doi:10.1093/eurheartj/ehr491
Linke A, Gerckens U, Wenaweser P, et. al. (2012) Treatment of High Risk Aortic Stenosis Patients with transcatheter Medtronic CoreValve Implantation: results from the International Multi-center ADVANCE Study. J Am Coll Cardiol 59(1s1): E3–E8 doi: 10.1016/S0735-1097(12)6009-6
Zahn R, Gerckens U, Grube E et al (2011) Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J 32:198–204. doi:10.1093/eurheartj/ehq339
Moat NE, Ludman P, de Belder MA et al (2011) Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the UK TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. J Am Coll Cardiol 58:2130–2138. doi:10.1016/j.jacc.2011.08.050
Gilard M, Eltchaninoff H, Iung B et al (2012) Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 366:1705–1715. doi:10.1056/NEJMoa1114705
Beckmann A, Hamm C, Figulla HR et al (2012) The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis. Thorac Cardiovasc Surg 60:319–325. doi:10.1055/s-0032-1323155
Hamm CW, Möllmann H, Holzhey D et al (2013) The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J. doi:10.1093/eurheartj/eht381
Di Mario C, Eltchaninoff H, Moat N et al (2013) The 2011–12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients. EuroIntervention 8:1362–1371. doi:10.4244/EIJV8I12A209
Zahn R, Gerckens U, Linke A et al (2013) Predictors of one-year mortality after transcatheter aortic valve implantation for severe symptomatic aortic stenosis. Am J Cardiol 112:272–279. doi:10.1016/j.amjcard.2013.03.024
Ledwoch J, Franke J, Gerckens U et al (2013) Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry. Catheter Cardiovasc Interv 82:E569–E577. doi:10.1002/ccd.24915
Zahn R, Schiele R, Gerckens U et al (2013) Transcatheter aortic valve implantation in patients with “porcelain” aorta (from a Multicenter Real World Registry). Am J Cardiol 111:602–608. doi:10.1016/j.amjcard.2012.11.004
Buellesfeld L, Gerckens U, Erbel R et al (2012) Age-stratified baseline and outcome characteristics of patients undergoing transcatheter aortic valve implantation: results from the German multicenter registry. J Invasive Cardiol 24:531–536
Sinning J-M, Horack M, Grube E et al (2012) The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry. Am Heart J 164(102–10):e1. doi:10.1016/j.ahj.2012.04.016
Lauten A, Zahn R, Horack M et al (2012) Transcatheter aortic valve implantation in patients with low-flow, low-gradient aortic stenosis. JACC Cardiovasc Interv 5:552–559. doi:10.1016/j.jcin.2012.04.001
Fiorina C, Barbanti M, De Carlo M et al (2013) One year clinical outcomes in patients with severe aortic stenosis and left ventricular systolic dysfunction undergoing transcatheteter aortic valve implantation: results from the Italian CoreValve Registry. Int J Cardiol 168:4877–4879. doi:10.1016/j.ijcard.2013.07.049
D’Ascenzo F, Gonella A, Moretti C et al (2013) Gender differences in patients undergoing TAVI: a multicentre study. EuroIntervention 9:367–372. doi:10.4244/EIJV9I3A59
Ussia GP, Barbanti M, Colombo A et al (2013) Impact of coronary artery disease in elderly patients undergoing transcatheter aortic valve implantation: insight from the Italian CoreValve Registry. Int J Cardiol 167:943–950. doi:10.1016/j.ijcard.2012.03.089
Tamburino C, Barbanti M, Capodanno D et al (2012) Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis. Am J Cardiol 109:1487–1493. doi:10.1016/j.amjcard.2012.01.364
Khawaja MZ, Rajani R, Cook A et al (2011) Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative). Circulation 123:951–960. doi:10.1161/CIRCULATIONAHA.109.927152
Roy DA, Schaefer U, Guetta V et al (2013) Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol 61:1577–1584. doi:10.1016/j.jacc.2013.01.018
Petronio AS, De Carlo M, Bedogni F et al (2012) 2-year results of CoreValve implantation through the subclavian access: a propensity-matched comparison with the femoral access. J Am Coll Cardiol 60:502–507. doi:10.1016/j.jacc.2012.04.014
van Mieghem NM, Chieffo A, Dumonteil N et al (2013) Trends in outcome after transfemoral transcatheter aortic valve implantation. Am Heart J 165:183–192. doi:10.1016/j.ahj.2012.11.002
Lange R, Bleiziffer S, Mazzitelli D et al (2012) Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients: a glimpse into the future. J Am Coll Cardiol 59:280–287. doi:10.1016/j.jacc.2011.10.868
Abdel-Wahab M, Zahn R, Horack M et al (2012) Transcatheter aortic valve implantation in patients with and without concomitant coronary artery disease: comparison of characteristics and early outcome in the German multicenter TAVI registry. Clin Res Cardiol 101:973–981. doi:10.1007/s00392-012-0486-5
Abdel-Wahab M, Mostafa AE, Richardt G (2012) A case of rotational atherectomy after implantation of the Medtronic CoreValve bioprosthesis. Clin Res Cardiol 101:595–597. doi:10.1007/s00392-012-0443-3
Akin I, Kische S, Schneider H et al (2012) Surface and intracardiac ECG for discriminating conduction disorders after CoreValve implantation. Clin Res Cardiol 101:357–364. doi:10.1007/s00392-011-0400-6
Abdel-Wahab M, Zahn R, Horack M et al (2011) Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart 97:899–906. doi:10.1136/hrt.2010.217158
Tofield A (2013) The Lotus valve for transcatheter aortic valve implantation. Eur Heart J 34:2335
Carroll JD, Edwards FH, Marinac-Dabic D et al (2013) The STS-ACC transcatheter valve therapy national registry. JACC 62:1026–1034. doi:10.1016/j.jacc.2013.03.060
Chieffo A, Buchanan GL, van Mieghem NM et al (2013) Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol 61:830–836. doi:10.1016/j.jacc.2012.11.050
Acknowledgments
Dr. Linke is a consultant to Medtronic and St. Jude Medical. He received speaker honoraria from Edwards, Medtronic and St. Jude Medical and is a proctor for Medtronic, Edwards and St. Jude Medical. Prof. Schuler and Dr. Haussig report no conflict of interest.
Author information
Authors and Affiliations
Corresponding author
Additional information
This article is part of a series of 3 articles on TAVI that will be published in subsequent issues.
Rights and permissions
About this article
Cite this article
Haussig, S., Schuler, G. & Linke, A. Worldwide TAVI registries: what have we learned?. Clin Res Cardiol 103, 603–612 (2014). https://doi.org/10.1007/s00392-014-0698-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00392-014-0698-y