TY - JOUR
T1 - Incidence, Causes, and Outcomes Associated with Urgent Implantation of a Supplementary Valve during Transcatheter Aortic Valve Replacement
AU - Landes, Uri
AU - Witberg, Guy
AU - Sathananthan, Janarthanan
AU - Kim, Won Keun
AU - Codner, Pablo
AU - Buzzatti, Nicola
AU - Montorfano, Matteo
AU - Godfrey, Rebecca
AU - Hildick-Smith, David
AU - Fraccaro, Chiara
AU - Tarantini, Giuseppe
AU - De Backer, Ole
AU - Sondergaard, Lars
AU - Okuno, Taishi
AU - Pilgrim, Thomas
AU - Rodés-Cabau, Josep
AU - Jaffe, Ronen
AU - Eitan, Amnon
AU - Sinning, Jan Malte
AU - Ielasi, Alfonso
AU - Eltchaninoff, Helene
AU - Maurovich-Horvat, Pál
AU - Merkely, Bela
AU - Guerrero, Mayra
AU - El Sabbagh, Abdallah
AU - Ruile, Philipp
AU - Barbanti, Marco
AU - Redwood, Simon R.
AU - Van Mieghem, Nicolas M.
AU - Van Wiechen, Maarten P.H.
AU - Finkelstein, Ariel
AU - Bunc, Matjaz
AU - Leon, Martin B.
AU - Kornowski, Ran
AU - Webb, John G.
N1 - Publisher Copyright:
© 2021 American Medical Association. All rights reserved.
PY - 2021/8
Y1 - 2021/8
N2 - Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. Objective: To examine the incidence, causes, and outcomes of 2V-TAVR. Design, Setting, and Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. Exposures: Urgent implantation of a supplementary valve during TAVR. Main Outcomes and Measures: Mortality at 30 days and 1 year. Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P =.02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P <.001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P =.02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P <.001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P <.001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P =.004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P <.001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P =.10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P =.09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P =.03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P =.03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P =.04) at 30 days, 1.45 (95% CI, 0.84-2.51; P =.18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P =.42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR. Conclusions and Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.
AB - Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. Objective: To examine the incidence, causes, and outcomes of 2V-TAVR. Design, Setting, and Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. Exposures: Urgent implantation of a supplementary valve during TAVR. Main Outcomes and Measures: Mortality at 30 days and 1 year. Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P =.02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P <.001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P =.02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P <.001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P <.001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P =.004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P <.001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P =.10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P =.09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P =.03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P =.03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P =.04) at 30 days, 1.45 (95% CI, 0.84-2.51; P =.18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P =.42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR. Conclusions and Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.
UR - http://www.scopus.com/inward/record.url?scp=85106871209&partnerID=8YFLogxK
U2 - 10.1001/jamacardio.2021.1145
DO - 10.1001/jamacardio.2021.1145
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C2 - 34009236
AN - SCOPUS:85106871209
SN - 2380-6583
VL - 6
SP - 936
EP - 944
JO - JAMA Cardiology
JF - JAMA Cardiology
IS - 8
ER -