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Supplementary Valve Implantation During TAVR
Quick Takes
- This cohort study reports that 2V-TAVR incidence has decreased over time but was associated with a higher burden of complications, morbidity, and mortality compared with matched patients undergoing 1V-TAVR.
- Some patient characteristics (mainly bicuspid or regurgitant aortic valve) and procedural factors (TAVR access and type, although not repositionability) independently increased the risk of needing 2V-TAVR.
- Given that 2V-TAVR was associated with a worse outcome in this study, its role remains unclear, especially in patients at low surgical risk.
Study Questions:
What are the incidence, causes, and outcomes of transcatheter aortic valve replacement (TAVR) when a supplementary valve is needed urgently during the procedure?
Methods:
The investigators conducted a retrospective cohort study using data from an international registry of 21,298 TAVR procedures performed from January 1, 2014–February 28, 2019. Among the 21,298 patients undergoing TAVR, 223 patients (1.0%) undergoing supplementary valve during the procedure (2-valve TAVR [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 1,065 (213:852) patients. The main outcome measure was 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% confidence interval [CI], 1.17-4.15; p = 0.02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; p < 0.001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; p = 0.02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; p < 0.001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; p < 0.001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; p = 0.004) 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 versus 1V-TAVR cohorts, the rate of device success was 147 (70.4%) versus 783 (92.2%) (p < 0.001), the rate of coronary obstruction was 5 (2.3%) versus 3 (0.4%) (p = 0.10), stroke rate was 9 (4.6%) versus 13 (1.6%) (p = 0.09), major bleeding rates were 25 (11.8%) versus 46 (5.5%) (p = 0.03), and annular rupture rate was 7 (3.3%) versus 3 (0.4%) (p = 0.03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; p = 0.04) at 30 days, 1.45 (95% CI, 0.84-2.51; p = 0.18) at 1 year, and 1.20 (95% CI, 0.77-1.88; p = 0.42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR.
Conclusions:
The authors concluded that compared with 1V-TAVR, 2V-TAVR is associated with a high burden of complications and mortality at 30 days, but not at 1 year.
Perspective:
This cohort study reports that 2V-TAVR incidence has decreased over time, from 3% in 2014 to 1% in 2018, but was associated with a higher burden of complications, morbidity, and mortality compared with matched patients undergoing 1V-TAVR. Malposition of the primary valve with residual paravalvular aortic regurgitation was the indication for most supplementary valve implants. Some patient characteristics (mainly bicuspid or regurgitant aortic valve) and procedural factors (TAVR access and type, although not repositionability) independently increased the risk of needing 2V-TAVR. It should be noted that because 2V-TAVR was associated with a worse outcome in this study, its role remains unclear, especially in patients at low surgical risk.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Insufficiency, Atrial Fibrillation, Cardiac Surgical Procedures, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Outcome Assessment, Health Care, Risk, Stroke, Transcatheter Aortic Valve Replacement
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