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 - Funding Information: reported serving as a consultant for Edwards Lifesciences and Medtronic during the conduct of the study. Dr Kim reported receiving personal fees from Abbott Laboratories, Boston Scientific, Edwards Lifesciences, Medtronic, and Meril outside the submitted work. Dr Hildick-Smith reported serving as an adviser or proctor to Edwards, Boston, and Medtronic. Dr Okuno reported receiving personal fees from Abbott Labories outside the submitted work. Dr Pilgrim reported receiving grants from Boston Scientific, Biotronik, and Edwards Lifesciences and personal fees from Boston Scientific, Biotronik, and HighLifeSAS outside the submitted work and serving as a proctor for Boston Scientific and Medtronic. Dr Rodés-Cabau reported receiving grants from Edwards Lifesciences and Medtronic outside the submitted work. Dr Sinning reported receiving personal fees from Medtronic, Boston Scientific, and Edwards Lifesciences during the conduct of the study. Dr Maurovich-Horvat reported being a shareholder in Neumann Medical Ltd outside the submitted work. Dr Merkely reported receiving speaker fees from Biotronik and Abbott Laboratories and grants from Medtronic and Boston Scientific outside the submitted work. Dr Guerrero reported receiving grants from Edwards Lifesciences during the conduct of the study and grants from Abbott Structural Heart outside the submitted work. Dr Redwood reported receiving speaker and proctor fees from Edwards Lifesciences during the conduct of the study. Dr Van Mieghem reported receiving grants from Abbott Laboratories, Boston Scientific, Medtronic, Funding Information: Edwards Lifesciences, PulseCath BV, and Daiichi Sankyo during the conduct of the study. Dr Bunc reported proctoring for TAVI, Edwards Lifesciences, Abbott Laboratories, Medtronic, and Meril. Dr Leon reported receiving grants from Edwards Lifescience to Columbia University as part of the clinical research contract and grants from Medtronic to Columbia University during the conduct of the study, nonfinancial support from the Edwards Advisory Board, and nonpaid and nonfinancial support from Medtronic Advisory board outside the submitted work. Dr Webb reported serving as a consultant to Edwards Lifesciences. No other disclosures were reported. Publisher Copyright: © 2021 American Medical Association. All rights reserved.

PY - 2021

Y1 - 2021

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.

U2 - 10.1001/jamacardio.2021.1145

DO - 10.1001/jamacardio.2021.1145

M3 - Journal article

C2 - 34009236

AN - SCOPUS:85106871209

VL - 6

SP - 936

EP - 944

JO - JAMA Cardiology

JF - JAMA Cardiology

SN - 2380-6583

IS - 8

ER -