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Original Investigation |

Transcatheter Aortic Valve Implantation in Failed Bioprosthetic Surgical Valves

Danny Dvir, MD1; John G. Webb, MD1; Sabine Bleiziffer, MD2; Miralem Pasic, MD, PhD3; Ron Waksman, MD4; Susheel Kodali, MD5; Marco Barbanti, MD1; Azeem Latib, MD6; Ulrich Schaefer, MD7; Josep Rodés-Cabau, MD8; Hendrik Treede, MD9; Nicolo Piazza, MD, PhD10; David Hildick-Smith, MD11; Dominique Himbert, MD12; Thomas Walther, MD13; Christian Hengstenberg, MD14; Henrik Nissen, MD, PhD15; Raffi Bekeredjian, MD16; Patrizia Presbitero, MD17; Enrico Ferrari, MD18; Amit Segev, MD19; Arend de Weger, MD20; Stephan Windecker, MD21; Neil E. Moat, FRCS22; Massimo Napodano, MD23; Manuel Wilbring, MD24; Alfredo G. Cerillo, MD25; Stephen Brecker, MD26; Didier Tchetche, MD27; Thierry Lefèvre, MD28; Federico De Marco, MD29; Claudia Fiorina, MD30; Anna Sonia Petronio, MD31; Rui C. Teles, MD32; Luca Testa, MD33; Jean-Claude Laborde, MD26; Martin B. Leon, MD5; Ran Kornowski, MD34; for the Valve-in-Valve International Data Registry Investigators
[+] Author Affiliations
1St Paul’s Hospital, Vancouver, British Columbia, Canada
2German Heart Center, Munich, Germany
3Deutsches Herzzentrum Berlin, Berlin, Germany
4Washington Hospital Center, Washington, DC
5Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
6San Raffaele Scientific Institute, Milan, Italy
7Asklepios Clinics St Georg, Hamburg, Germany
8Quebec Heart and Lung Institute, Quebec City, Quebec, Canada
9University Heart Center Hamburg, Hamburg, Germany
10Department of Interventional Cardiology at McGill University Health Centre, Montreal, Quebec, Canada
11Sussex Cardiac Centre, Brighton, England
12Hospital Bichat, Paris, France
13Kerckhoff Heart Center, Bad Nauheim, Germany
14Universitaetsklinikum Regensburg, Regensburg, Germany
15Odense University Hospital, Odense, Denmark
16University of Heidelberg, Heidelberg, Germany
17Hemodynamic and Invasive Cardiology Unit, IRCCS Istituto Clinico Humanitas, Milan, Italy.
18University Hospital of Lausanne, Lausanne, Switzerland
19Sheba Medical Center, Ramat Gan, Israel
20Leids Universitair Medisch Centrum, Leiden, the Netherlands
21Bern University Hospital, Bern, Switzerland
22Royal Brompton Hospital, London, England
23Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Padua, Italy
24University Heart Center Dresden, Dresden, Germany
25G. Pasquinucci Hospital, Massa, Italy
26St George’s Hospital, London, England
27Clinique Pasteur, Toulouse, France
28Hopital Jacques Cartier, Massy, France
29Ospedale Niguarda Ca’Granda, Milan, Italy
30Azienda Ospedaliere Spedali Civili di Brescia, Brescia, Italy
31Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy
32Hospital de Santa Cruz, Lisbon, Portugal
33Clinical Institute S. Ambrogio, Milan, Italy
34Rabin Medical Center and Tel Aviv University, Tel Aviv, Israel
JAMA. 2014;312(2):162-170. doi:10.1001/jama.2014.7246.
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Importance  Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed.

Objective  To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves.

Design, Setting, and Participants  Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves.

Main Outcomes and Measures  Survival, stroke, and New York Heart Association functional class.

Results  Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008).

Conclusions and Relevance  In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.

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Figure 1.
Time-to-Event Curves in Patients Undergoing Valve-in-Valve Procedures

aSurgical valve sizes were as follows: small, label size ≤21 mm; intermediate, >21 mm and <25 mm; and large, ≥25 mm. In 11 patients (2.4%), label size was unknown.

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Figure 2.
Results of Multivariable Analyses for Correlates for 1-Year Mortality After Valve-in-Valve Implantation

aThe Society of Thoracic Surgeons (STS) score is a prediction of operative mortality after conventional surgical valve replacement (http://riskcalc.sts.org/de.aspx).

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