Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison

TY - JOUR

T1 - Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison

AU - Giannini, C.

AU - De Carlo, M.

AU - Tamburino, C.

AU - Ettori, F.

AU - Latib, A.M.

AU - Bedogni, F.

AU - Bruschi, G.

AU - Presbitero, P.

AU - Poli, A.

AU - Fabbiocchi, F.

AU - Violini, R.

AU - Trani, C.

AU - Giudice, P.

AU - Barbanti, M.

AU - Adamo, M.

AU - Colombo, P.

AU - Benincasa, S.

AU - Agnifili, M.

AU - Petronio, A.S.

N1 - Cited By :1 Export Date: 2 March 2018 CODEN: IJCDD Correspondence Address: Giannini, C.; Vascular and Cardio-Thoracic Department, Azienda Ospedaliero Universitaria Pisana, Via Paradisa 2, Italy; email: crigiannini@hotmail.it Tradenames: Medtronic CoreValve, Medtronic, United States Manufacturers: Abbott Vascular; Medtronic, United States References: Barbanti, M., Petronio, A.S., Ettori, F., 5-year outcomes after transcatheter aortic valve implantation with CoreValve prosthesis (2015) JACC Cardiovasc. Interv., 8, pp. 1084-1091; Mack, M.J., Leon, M.B., Smith, C.R., 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 (2015) Lancet, 385, pp. 2477-2484; Smith, C.R., Leon, M.B., Mack, M.J., Transcatheter versus surgical aortic-valve replacement in high-risk patients (2011) N. Engl. J. 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Cardiol., 63, pp. 1100-1109; Kodali, S., Pibarot, P., Douglas, P.S., Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients and impact on outcomes (2015) Eur. Heart J., 36, pp. 449-456; Leon, M.B., Smith, C.R., Mack, M., Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery (2010) N. Engl. J. Med., 363, pp. 1597-1607; Grube, E., Laborde, J.C., Gerckens, U., Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study (2006) Circulation, 114, pp. 1616-1624; Barbanti, M., Binder, R.K., Freeman, M., Impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement (2013) EuroIntervention, 9, pp. 929-935; Schaefer, A., Treede, H., Schoen, G., Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves (2016) Eur. J. Cardiothorac. Surg., 50, pp. 368-373; Ruparelia, N., Latib, A., Kawamoto, H., A comparison between first-generation and second-generation transcatheter aortic valve implantation (TAVI) devices: a propensity-matched single-center experience (2016) J. Invasive Cardiol., 28, pp. 210-216; Nijhoff, F., Abawi, M., Agostoni, P., Ramjankhan, F.Z., Doevendans, P.A., Stella, P.R., Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison (2015) Circ. Cardiovasc. Interv., 8; Binder, R.K., Stortecky, S., Heg, D., 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 (2015) Circ. Cardiovasc. Interv., 8; Ando, T., Briasoulis, A., Holmes, A.A., Taub, C.C., Takagi, H., Afonso, L., Sapien 3 versus Sapien XT prosthetic valves in transcatheter aortic valve implantation: a meta-analysis (2016) Int. J. Cardiol., 220, pp. 472-478; Piazza, N., Martucci, G., Lachapelle, K., First-in-human experience with the Medtronic CoreValve Evolut R (2014) EuroIntervention, 9, pp. 1260-1263; Manoharan, G., Walton, A.S., Brecker, S.J., Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system (2015) JACC Cardiovasc. Interv., 8, pp. 1359-1367; Ganesh, M., Outcomes at 1 year with a repositionable self-expanding transcatheter aortic valve (2015) Transcatheter Cardiovascular Therapeutics (TCT), , (San Francisco) October 12; Petronio, A.S., De Carlo, M., Bedogni, F., 2-year results of CoreValve implantation through the subclavian access: a propensity-matched comparison with the femoral access (2012) J. Am. Coll. Cardiol., 60, pp. 502-507; Tamburino, C., Capodanno, D., Ramondo, A., Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis (2011) Circulation, 123, pp. 299-308; Petronio, A.S., Giannini, C., De Carlo, M., Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry (2016) EuroIntervention, 12, pp. 381-388; Kappetein, A.P., Head, S.J., Généreux, P., Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (2012) J. Am. Coll. Cardiol., 60, pp. 1438-1454; Petronio, A.S., Sinning, J.M., Van Mieghem, N., Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the Medtronic CoreValve system: the CoreValve prospective, international, post-market ADVANCE-II study (2015) JACC Cardiovasc. Interv., 8, pp. 837-846; Sellers, R.D., Levy, M.J., Amplatz, K., Lillehei, C.W., Left retrograde cardioangiography in acquired cardiac disease: technic, indications and interpretations in 700 cases (1964) Am. J. Cardiol., 14, pp. 437-447; Holmes, D.R., Nishimura, R.A., Grover, F.L., Annual outcomes with transcatheter valve therapy: from the STS/ACC TVT registry (2015) J. Am. Coll. Cardiol., 66, pp. 2813-2823; Schulz, E., Jabs, A., Gori, T., Transcatheter aortic valve implantation with the new-generation Evolut R™ Comparison with CoreValve® in a single center cohort (2016) IJC Heart & Vasculature; Noble, S., Stortecky, S., Heg, D., Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis (2017) EuroIntervention; Gomes, B., Geis, N.A., Chorianopoulos, E., Improvements of procedural results with a new-generation self-expanding transfemoral aortic valve prosthesis in comparison to the old-generation device (2017) J. Interv. Cardiol., 30, pp. 72-78; Landes, U., Bental, T., Barsheshet, A., Comparative matched outcome of Evolut-R vs CoreValve transcatheter aortic valve implantation (2017) J. Invasive Cardiol., 29, pp. 69-74; Herrmann, H.C., Thourani, V.H., Kodali, S.K., One-year clinical outcomes with Sapien 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis (2016) Circulation, 134, pp. 130-140; Généreux, P., Cohen, D.J., Mack, M., Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (2014) J. Am. Coll. Cardiol., 64, pp. 2605-2615; Kodali, S.K., Williams, M.R., Smith, C.R., Two-year outcomes after transcatheter or surgical aortic-valve replacement (2012) N. Engl. J. Med., 366, pp. 1686-1695; Gooley, R.P., Talman, A.H., Cameron, J.D., Lockwood, S.M., Meredith, I.T., Comparison of self-expanding and mechanically expanded transcatheter aortic valve prostheses (2015) JACC Cardiovasc. Interv., 8, pp. 962-971; Nombela-Franco, L., Rodes-Cabau, J., Delarochelliere, R., Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic valve implantation with a balloon-expandable valve (2012) JACC Cardiovasc. Interv., 5, pp. 499-512; Pagnesi, M., Jabbour, R.J., Latib, A., Usefulness of predilation before transcatheter aortic valve implantation (2016) Am. J. Cardiol., 118, pp. 107-112; Siontis, G.C., Jüni, P., Pilgrim, T., Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis (2014) J. Am. Coll. Cardiol., 64, pp. 129-140; Abdel-Wahab, M., Mehilli, J., Frerker, C., Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial (2014) JAMA, 311, pp. 1503-1514; Meredith Am, I.T., Walters, D.L., Dumonteil, N., Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study (2014) J. Am. Coll. Cardiol., 64, pp. 1339-1348; Wöhrle, J., Gonska, B., Rodewald, C., Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve (2015) Int. J. Cardiol., 195, pp. 171-175

PY - 2017

Y1 - 2017

N2 - Background Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. Methods Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n = 1846) or Evolut R (n = 302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. Results Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p = 0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. Conclusion In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1 year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning. © 2017 Elsevier B.V.

AB - Background Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. Methods Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n = 1846) or Evolut R (n = 302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. Results Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p = 0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. Conclusion In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1 year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning. © 2017 Elsevier B.V.

KW - Self-expandable transcatheter aortic valve

KW - Transcatheter aortic valve implantation

KW - acute kidney failure

KW - aged

KW - aortic stenosis

KW - aortic valve prosthesis

KW - Article

KW - artificial heart pacemaker

KW - bleeding

KW - blood transfusion

KW - cerebrovascular accident

KW - clinical outcome

KW - controlled clinical trial

KW - controlled study

KW - female

KW - hospitalization

KW - human

KW - incidence

KW - major clinical study

KW - major vascular access complication

KW - male

KW - overall survival

KW - paravalvular leak

KW - percutaneous aortic valve

KW - priority journal

KW - prognosis

KW - prospective study

KW - surgical risk

KW - survival rate

KW - transcatheter aortic valve implantation

KW - vascular closure device

KW - vascular disease

KW - very elderly

U2 - 10.1016/j.ijcard.2017.05.095

DO - 10.1016/j.ijcard.2017.05.095

M3 - Article

VL - 243

SP - 126

EP - 131

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -