Produção Nacional
Revisado por pares
Outcomes in Valve-in-Valve Transcatheter Aortic Valve Implantation
2022; Elsevier BV; Volume: 172; Linguagem: Inglês
10.1016/j.amjcard.2022.02.028
ISSN1879-1913
AutoresAstrid C. van Nieuwkerk, Raquel B. Santos, Eduard Fernández‐Nofrerías, Didier Tchétché, Fábio Sândoli de Brito, Marco Barbanti, Ran Kornowski, Azeem Latib, Augusto D’Onofrio, Flavio Ribichini, Vicente Mainar, Nicolas Dumonteil, Jan Baan, Alexandre Abizaid, Samantha Sartori, Paola D’Errigo, Giuseppe Tarantini, Mattia Lunardi, Katia Orvin, Matteo Pagnesi, Garikoitz Lasa Larraya, Angie Ghattas, George Dangas, Roxana Mehran, Ronak Delewi,
Tópico(s)Cardiac Imaging and Diagnostics
ResumoThe use of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasing, but studies evaluating clinical outcomes in these patients are scarce. Also, there are limited data to guide the choice of valve type in ViV-TAVI. Therefore, this CENTER-study evaluated clinical outcomes in patients with ViV-TAVI compared to patients with native valve TAVI (NV-TAVI). In addition, we compared outcomes in patients with ViV-TAVI treated with self-expandable versus balloon-expandable valves. A total of 256 patients with ViV-TAVI and 11333 patients with NV-TAVI were matched 1:2 using propensity score matching, resulting in 256 patients with ViV-TAVI and 512 patients with NV-TAVI. Mean age was 81±7 years, 58% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 6.3% (4.0% to 12.8%). Mortality rates were comparable between ViV-TAVI and NV-TAVI patients at 30 days (4.1% vs 5.9%, p = 0.30) and 1 year (14.2% vs 17.3%, p = 0.34). Stroke rates were also similar at 30 days (2.8% vs 1.8%, p = 0.38) and 1 year (4.9% vs 4.3%, p = 0.74). Permanent pacemakers were less frequently implanted in patients with ViV-TAVI (8.8% vs 15.0%, relative risk 0.59, 95% confidence interval [CI] 0.37 to 0.92, p = 0.02). Patients with ViV-TAVI were treated with self-expandable valves (n = 162) and balloon-expandable valves (n = 94). Thirty-day major bleeding was less frequent in patients with self-expandable valves (3% vs 13%, odds ratio 5.12, 95% CI 1.42 to 18.52, p = 0.01). Thirty-day mortality was numerically lower in patients with self-expandable valves (3% vs 7%, odds ratio 3.35, 95% CI 0.77 to 14.51, p = 0.11). In conclusion, ViV-TAVI seems a safe and effective treatment for failing bioprosthetic valves with low mortality and stroke rates comparable to NV-TAVI for both valve types. The use of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasing, but studies evaluating clinical outcomes in these patients are scarce. Also, there are limited data to guide the choice of valve type in ViV-TAVI. Therefore, this CENTER-study evaluated clinical outcomes in patients with ViV-TAVI compared to patients with native valve TAVI (NV-TAVI). In addition, we compared outcomes in patients with ViV-TAVI treated with self-expandable versus balloon-expandable valves. A total of 256 patients with ViV-TAVI and 11333 patients with NV-TAVI were matched 1:2 using propensity score matching, resulting in 256 patients with ViV-TAVI and 512 patients with NV-TAVI. Mean age was 81±7 years, 58% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 6.3% (4.0% to 12.8%). Mortality rates were comparable between ViV-TAVI and NV-TAVI patients at 30 days (4.1% vs 5.9%, p = 0.30) and 1 year (14.2% vs 17.3%, p = 0.34). Stroke rates were also similar at 30 days (2.8% vs 1.8%, p = 0.38) and 1 year (4.9% vs 4.3%, p = 0.74). Permanent pacemakers were less frequently implanted in patients with ViV-TAVI (8.8% vs 15.0%, relative risk 0.59, 95% confidence interval [CI] 0.37 to 0.92, p = 0.02). Patients with ViV-TAVI were treated with self-expandable valves (n = 162) and balloon-expandable valves (n = 94). Thirty-day major bleeding was less frequent in patients with self-expandable valves (3% vs 13%, odds ratio 5.12, 95% CI 1.42 to 18.52, p = 0.01). Thirty-day mortality was numerically lower in patients with self-expandable valves (3% vs 7%, odds ratio 3.35, 95% CI 0.77 to 14.51, p = 0.11). In conclusion, ViV-TAVI seems a safe and effective treatment for failing bioprosthetic valves with low mortality and stroke rates comparable to NV-TAVI for both valve types. Symptomatic severe aortic valve stenosis is increasingly treated with bioprosthetic valves.1Isaacs AJ Shuhaiber J Salemi A Isom OW Sedrakyan A. National trends in utilization and in-hospital outcomes of mechanical versus bioprosthetic aortic valve replacements.J Thorac Cardiovasc Surg. 2015; 149 (e3): 1262-1269Abstract Full Text Full Text PDF PubMed Scopus (171) Google Scholar However, these valves have limited durability. A growing number of patients present with failing bioprosthetic valves.2Rodriguez-Gabella T Voisine P Puri R Pibarot P Rodés-Cabau J. Aortic bioprosthetic valve durability: incidence, mechanisms, predictors, and management of surgical and transcatheter valve degeneration.J Am Coll Cardiol. 2017; 70: 1013-1028Crossref PubMed Scopus (173) Google Scholar They can be treated with either redo surgical aortic valve replacement (SAVR) or valve-in-valve transcatheter aortic valve implantation (ViV-TAVI). ViV-TAVI seems to have better short-term outcomes,3Deharo P Bisson A Herbert J Lacour T Etienne CS Porto A Theron A Collart F Bourguignon T Cuisset T Fauchier L. Transcatheter valve-in-valve aortic valve replacement as an alternative to surgical re-replacement.J Am Coll Cardiol. 2020; 76: 489-499Crossref PubMed Scopus (65) Google Scholar, 4Hirji SA Percy ED Zogg CK Malarczyk A Harloff MT Yazdchi F Kaneko T. Comparison of in-hospital outcomes and readmissions for valve-in-valve transcatheter aortic valve replacement vs. reoperative surgical aortic valve replacement: a contemporary assessment of real-world outcomes.Eur Heart J. 2020; 41: 2747-2755Crossref PubMed Scopus (64) Google Scholar, 5Malik AH Yandrapalli S Zaid S Shetty SS Aronow WS Ahmad H Tang GHL. Valve-in-valve transcatheter implantation versus redo surgical aortic valve replacement.Am J Cardiol. 2020; 125: 1378-1384Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar but longer-term outcomes are limited and conflicting.3Deharo P Bisson A Herbert J Lacour T Etienne CS Porto A Theron A Collart F Bourguignon T Cuisset T Fauchier L. Transcatheter valve-in-valve aortic valve replacement as an alternative to surgical re-replacement.J Am Coll Cardiol. 2020; 76: 489-499Crossref PubMed Scopus (65) Google Scholar,6Tam DY Dharma C Rocha RV Ouzounian M Wijeysundera HC Austin PC Chikwe J Gaudino M Fremes SE. Transcatheter ViV versus redo surgical AVR for the management of failed biological prosthesis: early and late outcomes in a propensity-matched cohort.JACC Cardiovasc Interv. 2020; 13: 765-774Crossref PubMed Scopus (58) Google Scholar,7Majmundar M Doshi R Kumar A Johnston D Brockett J Kanaa'N A Lahorra JA Svensson LG Krishnaswamy A Reed GW Puri R Kapadia SR Kalra A Valve-in-valve transcatheter aortic valve implantation versus repeat surgical aortic valve replacement in patients with a failed aortic bioprosthesis.EuroIntervention. 2022; 17: 1227-1237Crossref Scopus (10) Google Scholar Both self-expandable (SE) and balloon-expandable (BE) valves are used in ViV-TAVI procedures. These valves have a fundamentally different mechanism and risk-benefit profile,8Vlastra W Chandrasekhar J Muñoz-Garcia AJ Tchétché D De Brito FS Barbanti M Kornowski R Latib A D'Onofrio A Ribichini F Baan J Tijssen JGP Trillo-Nouche R Dumonteil N Abizaid A Sartori S D'Errigo P Tarantini G Lunardi M Orvin K Pagnesi M Del Valle R Modine T Dangas G Mehran R Piek JJ Delewi R Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration.Eur Heart J. 2019; 40: 456-465Crossref PubMed Scopus (68) Google Scholar, 9Van Belle E Vincent F Labreuche J Auffret V Debry N Lefèvre T Eltchaninoff H Manigold T Gilard M Verhoye JP Himbert D Koning R Collet JP Leprince P Teiger E Duhamel A Cosenza A Schurtz G Porouchani S Lattuca B Robin E Coisne A Modine T Richardson M Joly P Rioufol G Ghostine S Bar O Amabile N Champagnac D Ohlmann P Meneveau N Lhermusier T Leroux L Leclercq F Gandet T Pinaud F Cuisset T Motreff P Souteyrand G Iung B Folliguet T Commeau P Cayla G Bayet G Darremont O Spaulding C Le Breton H Delhaye C Balloon-expandable versus self-expanding transcatheter aortic valve replacement: a propensity-matched comparison from the FRANCE-TAVI registry.Circulation. 2020; 141: 243-259Crossref PubMed Scopus (74) Google Scholar, 10Abdel-Wahab M Landt M Neumann FJ Massberg S Frerker C Kurz T Kaur J Toelg R Sachse S Jochheim D Schäfer U El-Mawardy M Robinson DR Richardt G Investigators CHOICE 5-year outcomes after TAVR with balloon-expandable versus self-expanding valves: results from the CHOICE randomized clinical trial.JACC Cardiovasc Interv. 2020; 13: 1071-1082Crossref PubMed Scopus (74) Google Scholar but there is little evidence-based guidance on the choice of valve type in patients with ViV-TAVI. This study aimed to assess clinical outcomes in (1) patients with ViV-TAVI compared with patients with native valve TAVI (NV-TAVI) as a benchmark for clinical context; (2) patients with ViV-TAVI receiving SE versus BE valves.MethodsThe CENTER-collaboration is an international patient-level study including patients with severe aortic valve stenosis who underwent transfemoral TAVI with BE devices (Edwards Lifesciences Inc., Irvine, California) or SE devices (Medtronic Inc., Minneapolis, Minnesota). The study is registered at clinicaltrials.gov (NCT03588247). The dataset consists of 10 original studies: 4 single-center prospective registries, 3 national registries, 2 multicenter prospective registries, and 1 randomized clinical trial, selected through a systematic search.11Bernardi FLM Ribeiro HB Carvalho LA Sarmento-Leite R Mangione JA Lemos PA Abizaid A Grube E Rodés-Cabau J De Brito FS Direct transcatheter heart valve implantation versus implantation with balloon predilatation: insights from the Brazilian Transcatheter Aortic Valve Replacement Registry.Circ Cardiovasc Interv. 2016; 9: 1-9Crossref Scopus (36) Google Scholar, 12Tchetche D Farah B Misuraca L Pierri A Vahdat O Lereun C Dumonteil N Modine T Laskar M Eltchaninoff H Himbert D Iung B Teiger E Chevreul K Lievre M Lefevre T Donzeau-Gouge P Gilard M Fajadet J. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy.JACC Cardiovasc Interv. 2014; 7: 1138-1145Crossref PubMed Scopus (53) Google Scholar, 13Pagnesi M Jabbour RJ Latib A Kawamoto H Tanaka A Regazzoli D Mangieri A Montalto C Ancona MB Giannini F Chieffo A Montorfano M Monaco F Castiglioni A Alfieri O Colombo A. Usefulness of predilation before transcatheter aortic valve implantation.Am J Cardiol. 2016; 118: 107-112Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar, 14Lunardi M Pesarini G Zivelonghi C Piccoli A Geremia G Ariotti S Rossi A Gambaro A Gottin L Faggian G Vassanelli C Ribichini F. Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency.Open Heart. 2016; 3e000420Crossref Google Scholar, 15Tamburino C Barbanti M D'Errigo P Ranucci M Onorati F Covello RD Santini F Rosato S Santoro G Fusco D Grossi C Seccareccia F Research Group OBSERVANT 1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement: results from the Italian OBSERVANT study.J Am Coll Cardiol. 2015; 66: 804-812Crossref PubMed Scopus (145) Google Scholar, 16Codner P Levi A Gargiulo G Praz F Hayashida K Watanabe Y Mylotte D Debry N Barbanti M Lefèvre T Modine T Bosmans J Windecker S Barbash I Sinning JM Nickenig G Barsheshet A Kornowski R. Impact of renal dysfunction on results of transcatheter aortic valve replacement outcomes in a large multicenter cohort.Am J Cardiol. 2016; 118: 1888-1896Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar, 17D'Onofrio A Facchin M Besola L Manzan E Tessari C Bizzotto E Bianco R Tarantini G Napodano M Fraccaro C Buja P Covolo E Yzeiraj E Pittarello D Isabella G Iliceto S Gerosa G. Intermediate clinical and hemodynamic outcomes after transcatheter aortic valve implantation.Ann Thorac Surg. 2016; 101 (Dissicussion 888): 881-888Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar, 18Sabaté M Cánovas S García E Hernández Antolín R Maroto L Hernández JM Alonso Briales JH Muñoz García AJ Gutiérrez-Ibañes E Rodríguez-Roda J In-hospital and mid-term predictors of mortality after transcatheter aortic valve implantation: data from the TAVI national registry 2010–2011.Rev Esp Cardiol (Engl Ed). 2013; 66: 949-958Crossref PubMed Scopus (71) Google Scholar, 19Dangas GD Lefèvre T Kupatt C Tchetche D Schäfer U Dumonteil N Webb JG Colombo A Windecker S Ten Berg JM Hildick-Smith D Mehran R Boekstegers P Linke A Tron C Van Belle E Asgar AW Fach A Jeger R Sardella G Hink HU Husser O Grube E Deliargyris EN Lechthaler I Bernstein D Wijngaard P Anthopoulos P Hengstenberg C BRAVO-3 Investigators. Bivalirudin versus heparin anticoagulation in transcatheter aortic valve replacement: the randomized BRAVO-3 trial.J Am Coll Cardiol. 2015; 66: 2860-2868Crossref PubMed Scopus (93) Google Scholar, 20Chieffo A Petronio AS Mehilli J Chandrasekhar J Sartori S Lefèvre T Presbitero P Capranzano P Tchetche D Iadanza A Sardella G Van Mieghem NM Meliga E Dumonteil N Fraccaro C Trabattoni D Mikhail GW Sharma S Ferrer MC Naber C Kievit P Faggioni M Snyder C Morice MC Mehran R WIN-TAVI InvestigatorsAcute and 30-day outcomes in women after TAVR: results from the WIN-TAVI (Women's international transcatheter aortic valve implantation) real-world registry.JACC Cardiovasc Interv. 2016; 9: 1589-1600Crossref PubMed Scopus (66) Google Scholar Patients were treated in the United States, Brazil, Israel, Spain, Italy, and France. Treatment indication and valve type were evaluated by the heart team of each center. All collaborators provided a database with baseline patient characteristics, echocardiographic data, procedural information, and long-term follow-up data according to the second Valve Academic Research Consortium (VARC-2) criteria.21Kappetein AP Head SJ Généreux P Piazza N Van Mieghem NM Blackstone EH Brott TG Cohen DJ Cutlip DE Van Es GA Hahn RT Kirtane AJ Krucoff MW Kodali S Mack MJ Mehran R Rodés-Cabau J Vranckx P Webb JG Windecker S Serruys PW Leon MB Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.EuroIntervention. 2012; 8: 782-795Crossref PubMed Scopus (165) Google Scholar A detailed description of study design, eligibility criteria, systematic search methodology, and data collection was previously published.8Vlastra W Chandrasekhar J Muñoz-Garcia AJ Tchétché D De Brito FS Barbanti M Kornowski R Latib A D'Onofrio A Ribichini F Baan J Tijssen JGP Trillo-Nouche R Dumonteil N Abizaid A Sartori S D'Errigo P Tarantini G Lunardi M Orvin K Pagnesi M Del Valle R Modine T Dangas G Mehran R Piek JJ Delewi R Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration.Eur Heart J. 2019; 40: 456-465Crossref PubMed Scopus (68) Google Scholar The study was conducted in accordance with the Declaration of Helsinki. All patients provided written informed consent. Ethical approval was given by the ethics committee of each center. Supplementary Table S1 lists the number of included patients with ViV-TAVI per original study.The main clinical end points of this study were all cause mortality and stroke at 30 days and 1 year after ViV-TAVI compared with patients with NV-TAVI. Secondary end points were periprocedural, in-hospital, and 30-day clinical outcomes as defined by VARC-2.21Kappetein AP Head SJ Généreux P Piazza N Van Mieghem NM Blackstone EH Brott TG Cohen DJ Cutlip DE Van Es GA Hahn RT Kirtane AJ Krucoff MW Kodali S Mack MJ Mehran R Rodés-Cabau J Vranckx P Webb JG Windecker S Serruys PW Leon MB Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.EuroIntervention. 2012; 8: 782-795Crossref PubMed Scopus (165) Google Scholar Periprocedural outcomes included conversion to surgery and device success. Device success was defined by VARC-221 as "the absence of procedural mortality and correct positioning of a single prosthetic heart valve into the proper anatomical location and intended performance of the prosthetic heart valve (no prosthesis patient mismatch and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, and no moderate or severe prosthetic valve regurgitation)". In-hospital and 30-day outcomes included major bleeding, myocardial infarction, new-onset atrial fibrillation, and implantation of a permanent pacemaker.Missing data in baseline medical history were estimated using multiple imputation methods. The imputation procedure and multivariate regression models were performed under the assumption that missing data were missing at random. Baseline continuous variables were tested for normal distribution and reported as mean with standard deviation or median with interquartile range (IQR, 25th to 75th percentile). Baseline differences between patients with ViV-TAVI and NV-TAVI were evaluated using the independent t test or Mann-Whitney U test. Baseline categorical variables were presented as frequencies and percentages, and differences between groups were tested using chi-square test. Renal function was measured as estimated glomerular filtration rate (eGFR). Renal failure was defined as eGFR <30 ml/min/1.73 m2. Propensity score matching methodology was applied to reduce treatment selection bias and potential confounding. We calculated the propensity score with logistic regression. Predictors for either treatment (ViV-TAVI or NV-TAVI) or clinical outcomes (30-day mortality and stroke) were included in the logistic regression model. Accordingly, the propensity score included 18 variables: age, gender, body mass index, history of myocardial infarction, history of coronary artery bypass graft, history of percutaneous coronary intervention, history of cerebrovascular events, hypertension, dyslipidemia, atrial fibrillation, history of peripheral vascular disease, diabetes mellitus, renal failure, mean aortic valve gradient, Logistic EuroSCORE, year of procedure, valve generation, and valve type. Each ViV-TAVI patient was matched to 2 patients with NV-TAVI based on the nearest propensity score using the nearest neighbor method, ratio 1:2. and no replacement. Differences in clinical outcomes between ViV-TAVI and NV-TAVI were tested with chi-square test in the unmatched and the propensity-matched cohort. The corresponding asymptotic 2-sided 95% confidence interval (CI) of the relative risk (RR) was reported.In the ViV-TAVI patient group, we compared outcomes between SE and BE valve recipients. We assessed baseline characteristics in patients with ViV-TAVI treated with SE versus BE valves as described earlier. To adjust for potential confounding and selection bias, we corrected outcomes in SE versus BE valves using a multivariate logistic regression model. Baseline characteristics of patients with ViV-TAVI were tested in a univariate logistic regression model as predictors for valve design (SE or BE) or 30-day mortality. If p <0.10 in the univariate model, the variable was added to the multivariate model. Accordingly, the multivariate logistic regression model included age, body mass index, history of peripheral vascular disease, renal failure, hypertension, history of percutaneous coronary intervention, history of myocardial infarction, year of ViV-TAVI procedure, and Logistic EuroSCORE. Both adjusted and unadjusted odds ratios (OR) and 95% CI were reported for clinical outcomes.21Kappetein AP Head SJ Généreux P Piazza N Van Mieghem NM Blackstone EH Brott TG Cohen DJ Cutlip DE Van Es GA Hahn RT Kirtane AJ Krucoff MW Kodali S Mack MJ Mehran R Rodés-Cabau J Vranckx P Webb JG Windecker S Serruys PW Leon MB Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.EuroIntervention. 2012; 8: 782-795Crossref PubMed Scopus (165) Google Scholar All statistical tests were 2-tailed, and a value of p <0.05 was considered statistically significant. Calculations were generated by SPSS Statistics for Windows, Version 26.0, (SPSS Inc,Chicago, Illinois).ResultsA total of 11,589 patients underwent transfemoral TAVI. Mean age was 81±7 years, 6,707 (58%) were women and median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 6.3% (IQR 4.0% to 12.8%). A total of 256 patients (2.2%) underwent ViV-TAVI, and 11,333 (97.8%) underwent NV-TAVI. Previously implanted bioprosthetic valves were mainly done by SAVR (n = 254), whereas 2 patients underwent TAVI. Patients receiving ViV-TAVI were younger and more often men compared with NV-TAVI patients. Supplementary Table S2 lists an overview of baseline characteristics.Patients treated with ViV-TAVI and NV-TAVI showed comparable unadjusted 30-day mortality and stroke rates. Also, 1-year mortality and stroke rates were similar. Device success was achieved in 90.5% of patients with ViV-TAVI versus 95.4% in NV-TAVI. In the ViV-TAVI group, device failure was associated with higher STS-PROM score (OR 1.1, 95% CI 1.0 to 1.1, p = 0.02), renal failure (OR 4.8, 95% CI 1.7 to 13.3, p = 0.003) and the use of earlier generation valves (OR 6.2, 95% CI 2.0 to 19.0, p = 0.002). Predictors for 30-day mortality were also higher STS-PROM (OR 1.1, 95% CI 1.0 to 1.5, p = 0.01) and renal failure (OR 10.2, 95% CI 2.7 to 38.3, p<0.001). Rates of in-hospital mortality, stroke, myocardial infarction, permanent pacemaker implantation, new-onset atrial fibrillation, and 30-day major bleeding did not differ significantly, as listed in Table 1.Table 1Clinical outcomes in the unmatched patient population who underwent valve-in-valve versus native valve transcatheter aortic valve implantationViV-TAVI (n=256)NV-TAVI (n=11333)RR (95%CI)P ValuePeriprocedural outcomes Conversion to surgery1 (0.4%)65 (0.6%)0.62 (0.09-4.48)0.64 Device success*According to the second valve academic research consortium definitions. # Subjects with preexisting atrial fibrillation were excluded from the analysis of new-onset atrial fibrillation.201 (90.5%)9121 (95.4%)0.95 (0.91-0.99)0.001In hospital outcomes Mortality11 (4.3%)493 (4.4%)0.98 (0.55-1.76)0.94 Stroke6 (2.3%)225 (2.0%)1.16 (0.52-2.59)0.72 Myocardial infarction2 (0.8%)76 (0.7%)1.13 (0.28-4.58)0.86 Permanent pacemaker22 (8.8%)1393 (13.5%)0.65 (0.44-0.97)0.03 New onset atrial fibrillation#3 (6.3%)253 (7.2%)0.87 (0.29-2.63)0.8130 day outcomes Mortality10 (3.8%)577 (5.7%)0.72 (0.39-1.33)0.29 Stroke7 (2.8%)259 (2.5%)1.13 (0.54-2.36)0.75 Major Bleeding13 (6.2%)611 (6.9%)0.90 (0.53-1.53)0.69One year outcomes Mortality29 (14.2%)1208 (16.4%)0.87 (0.62-1.22)0.41 Stroke10 (4.9%)375 (5.0%)0.98 (0.53-1.80)0.94CI = confidence interval; NV = native valve; RR = relative risk; TAVI = transcatheter aortic valve implantation; ViV = valve-in-valve. According to the second valve academic research consortium definitions. # Subjects with preexisting atrial fibrillation were excluded from the analysis of new-onset atrial fibrillation. Open table in a new tab Patients with ViV-TAVI and NV-TAVI were matched using propensity score methodology (ratio 1:2). Baseline characteristics of the matched population (ViV-TAVI n = 256 and NV-TAVI n = 512) are listed in Table 2. In the propensity-matched population, mortality and stroke rates were similar at 30 days and 1 year. Permanent pacemakers were less frequently implanted in patients with ViV-TAVI. In the ViV-TAVI group, there were numerically lower rates of device success and higher rates of myocardial infarction, but the threshold for statistical significance was not met. Myocardial infarction in patients with ViV-TAVI was because of coronary obstruction. One of these patients died during the procedure, whereas the other was discharged after 7 days and survived more than 2 years. Rates of major bleeding, conversion to open-heart surgery, and new-onset atrial fibrillation were comparable between patients with ViV-TAVI and NV-TAVI. Table 3 lists an overview of clinical outcomes in the matched population. Figure 1 presents time to mortality curves for the unmatched population and Figure 2 for the propensity-matched population.Table 2Baseline characteristics of the propensity-matched populationViV-TAVI (n=256)NV-TAVI (n=512)P ValuePatient characteristics Age (years)82 (78–85)82 (78–85)0.33 Women129 (50%)263 (51%)0.80 BMI (kg/m2)27 (24-29)27 (24-29)0.89 Prior myocardial infarction28 (11%)58 (11%)0.87 Prior PCI46 (18%)99 (19%)0.65 Prior CABG72 (28%)138 (27%)0.73 Diabetes mellitus68 (27%)148 (29%)0.50 Hypertension200 (78%)409 (80%)0.57 Dyslipidemia148 (58%)296 (58%)1.00 Peripheral vascular disease29 (11%)51 (10%)0.56 Coronary artery disease109 (43%)239 (47%)0.28 Atrial fibrillation72 (28%)136 (27%)0.65 Previous stroke or TIA33 (13%)58 (11%)0.53 eGFR <30 mL/min/1.73 m227 (11%)57 (11%)0.81 Logistic EuroSCORE (%)25.0 (15.4-36.5)20.9 (12.8-39.1)0.15 STS-PROM (%)6.3 (4.0-10.4)6.3 (3.9-14.2)0.47 Aortic mean gradient (mmHg)42.4 ±21.642.4±14.80.98 Aortic Valve Area (cm2)0.79±0.370.66±0.230.001Procedural characteristics Balloon-expandable valve (%)94 (37%)185 (46%)0.87 Year of procedure2014 (2013-2016)2015 (2012-2016)0.33 Third generation valves131 (51%)268 (52%)0.76The propensity matching score included the following: age, gender, body mass index, history of myocardial infarction, history of CABG, history of PCI, history of stroke or TIA, hypertension, dyslipidemia, atrial fibrillation, history of peripheral vascular disease, diabetes mellitus, renal failure, logistic EuroSCORE, year of procedure, valve generation, valve type, and mean aortic valve gradient.BMI = body mass index; CABG = coronary artery bypass graft; eGFR = estimated glomerular filtration rate; EuroSCORE = European System for Cardiac Operative Risk Evaluation; PCI = percutaneous coronary intervention; STS-PROM = Society of Thoracic Surgeons Predicted Risk of mortality; TIA = transient ischemic attack. Open table in a new tab Table 3Clinical outcomes of the propensity-matched populationViV-TAVI (n=256)NV-TAVI (n=512)RR (95% CI)P ValuePeriprocedural outcomes Conversion to surgery1 (0.4%)1 (0.2%)1.94 (0.12–30.90)0.63 Device success*According to the second valve academic research consortium definitions. # Subjects with preexisting atrial fibrillation were excluded from the analysis of new-onset atrial fibrillation. CI = confidence interval; NV = native valve; RR = relative risk; TAVI = transcatheter aortic valve implantation; ViV = valve-in-valve.201 (90.5%)413 (94.5%)0.96 (0.91-1.01)0.06In-hospital outcomes Mortality11 (4.3%)23 (4.6%)0.95 (0.47-1.92)0.88 Stroke6 (2.3%)8 (1.6%)1.48 (0.52-4.21)0.46 Myocardial infarction2 (0.8%)0 (0.0%)-0.05 Permanent pacemaker22 (8.8%)79 (15.0%)0.59 (0.37-0.92)0.02 New onset atrial fibrillation#3 (6.3%)13 (10.2%)0.62 (0.18-2.07)0.4230 day outcomes Mortality10 (4.1%)26 (5.9%)0.69 (0.34-1.40)0.30 Stroke7 (2.8%)8 (1.8%)1.57 (0.58-4.27)0.38 Major Bleeding13 (6.2%)13 (3.4%)1.83 (0.87-3.89)0.11One year outcomes Mortality29 (14.2%)60 (17.3%)0.82 (0.55-1.23)0.34 Stroke10 (4.9%)15 (4.3%)1.14 (0.53-2.50)0.74 According to the second valve academic research consortium definitions. # Subjects with preexisting atrial fibrillation were excluded from the analysis of new-onset atrial fibrillation.CI = confidence interval; NV = native valve; RR = relative risk; TAVI = transcatheter aortic valve implantation; ViV = valve-in-valve. Open table in a new tab Figure 2Mortality in patients who underwent valve-in-valve and native valve transcatheter aortic valve implantation in the propensity-matched population. One-year follow-up data were available in 68% of patients with NV-TAVI and 80% of patients with ViV-TAVI.View Large Image Figure ViewerDownload Hi-res image Download (PPT)In patients with ViV-TAVI , 162 (63%) were treated with SE valves and 94 (37%) with BE valves. Most baseline characteristics were comparable, as listed in Supplementary Table S3. However, a history of myocardial infarction and percutaneous coronary intervention was more frequently reported in patients with SE valves. Third-generation valves were used in 91 (56%) of SE valves and 40 (43%) of BE valves. An overview of clinical outcomes in patients with SE and BE ViV-TAVI is listed in Table 4. These outcomes were corrected for differences in baseline characteristics using multivariate logistic regression. Patients with SE valves had fewer instances of 30-day mortality than patients with BE valves. However, 1-year mortality rates and time-to-mortality curves (Figure 3) did not differ between patients receiving SE or BE valves. Major bleeding less frequently occurred in patients with SE valves. Patients with SE and BE ViV-TAVI showed comparable rates of device success, in-hospital mortality, stroke, myocardial infarction, and permanent pacemaker implantation.Table 4Outcomes of patients with valve-in-valve TAVI treated with self-expandable versus balloon-expandable valvesSelf-Expandable ViV-TAVI (n=162)Balloon-Expandable ViV-TAVI (n=94)Unadjusted OR (95% CI)p ValueAdjusted OR (95% CI)P ValuePeriprocedural outcomes Conversion to surgery1 (1%)0-0.99-0.99 Device success*According to the second valve academic research consortium definitions. CI = confidence interval; NV = native valve; OR = odds ratio; TAVI = transcatheter aortic valve implantation; ViV = valve-in-valve.123 (90%)78 (92%)1.27 (0.49-3.28)0.621.28 (0.43-3.750.66In hospital outcomes Mortality5 (3%)6 (7%)2.19 (0.65-7.39)0.212.55 (0.67-9.73)0.17 Stroke3 (2%)3 (3%)1.75 (0.35-8.84)0.502.39 (0.37-15.58)0.36 Myocardial infarction1 (1%)1 (1%)1.82 (0.11-29.40)0.67-0.99 Permanent pacemaker15 (9%)7 (8%)0.83 (
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