Health Status Outcomes 7 Years After Transcatheter or Surgical Aortic Valve Replacement in Low-Surgical Risk Patients With Aortic Stenosis: @JACCJournals

🥸 1️⃣ Patients with severe aortic stenosis and low surgical risk often live for many years after valve replacement. More than 80% survive at least 7 years, so health status long after transcatheter or surgical aortic valve replacement remains important when the two are compared.

🥸 2️⃣ The PARTNER 3 trial enrolled 1,000 patients at 71 centers in the United States, Canada, Japan, and New Zealand. Patients were assigned 1:1 to transfemoral transcatheter replacement with the SAPIEN 3 balloon expandable valve or to surgery. This analysis covers 7 years.

🥸 3️⃣ Patients completed the Kansas City Cardiomyopathy Questionnaire and the Short Form 36 at baseline, 1 month, 6 months, and yearly through 7 years. The primary outcome was the overall summary score (0 to 100). Gains of 5, 10, and 20 points are small, moderate, and large.

🥸 4️⃣ The analysis included 943 patients (494 transcatheter, 449 surgical). In Table 1, mean age was 73.5 years, 69.2% were men, and the mean baseline overall summary score was 70.9 points. At 7 years, 81.7% and 80.2% of survivors had questionnaire data (Supplemental Table 1).

🥸 5️⃣ From baseline to 7 years, the overall summary score rose by 12.9 points after transcatheter replacement (95% confidence interval 10.6 to 15.3) and 14.0 points after surgery (11.4 to 16.5). The transcatheter gain had peaked at 20.4 points at 6 months (Supplemental Table 3).

🥸 6️⃣ Figure 1 and Table 2 compare the groups over time. At 1 month, the mean overall summary score was 89.8 points after transcatheter replacement and 73.6 points after surgery, a difference of 16.2 points (95% confidence interval 14.3 to 18.1; P less than 0.001).

🥸 7️⃣ At 1 month, 92.5% of transcatheter patients and 62.4% of surgical patients had a meaningful improvement, defined as a score of 75 or higher or a gain of 10 points (Central Illustration). In Table 3, 62.6% and 33.9% were alive with a gain of at least 10 points at 30 days.

🥸 8️⃣ In Table 2, every questionnaire domain favored transcatheter replacement at 1 month: 24.0 points for social limitations, 17.7 for quality of life, 13.9 for physical limitations, and 10.5 for symptoms. Short Form 36 physical and mental scores differed by 7.6 and 4.0 points.

🥸 9️⃣ The mean score after surgery rose from 73.6 at 1 month to 88.9 at 6 months (Table 2). The overall summary score favored transcatheter replacement by 2.7 points at 6 months (95% confidence interval 1.1 to 4.4), 1.9 at 1 year (0.3 to 3.5), and 1.9 at 2 years (0.2 to 3.7).

🥸 🔟 At 2 years, 63.7% of transcatheter patients and 54.9% of surgical patients were alive with a gain of at least 10 points (Table 3; P=0.011). Cumulative response curves show a 9% absolute difference at 2 years that was no longer apparent at 7 years (Supplemental Figure 1).

🥸 1️⃣1️⃣ In years 3 through 7, the overall summary score did not differ significantly between groups (Figure 1). At 7 years, it was 82.8 points after transcatheter replacement and 84.3 points after surgery (difference minus 1.6; 95% confidence interval minus 4.1 to 1.0; P=0.22).

🥸 1️⃣2️⃣ At 2 years, social limitations (2.7 points) and quality of life (2.4 points) still favored transcatheter replacement. No domain differed significantly in years 3 through 7 (Table 2). Short Form 36 mental scores favored surgery by 1.2 and 1.3 points in years 4 and 5.

🥸 1️⃣3️⃣ At 7 years, 65.7% of transcatheter patients and 67.2% of surgical patients were alive with a score of at least 60 and no decline of 10 points or more from baseline (Table 3; P=0.695). With a threshold of 75 points, the rates were 58.4% and 61.7% (P=0.404).

🥸 1️⃣4️⃣ After recovery, scores declined by about 1 point per year. After transcatheter replacement, the gain in physical limitations score fell from 14.0 points at 6 months to 2.6 points at 7 years, and the gain in Short Form 36 physical score fell from 5.9 to 0.8 points.

🥸 1️⃣5️⃣ The time weighted average overall summary score while alive, which integrates each patient’s assessments through 7 years, was 88.2 points after transcatheter replacement and 85.5 points after surgery (mean difference 2.7 points; 95% confidence interval 1.0 to 4.4).

🥸 1️⃣6️⃣ With multiple imputation, the difference at 7 years was minus 2.5 points, toward surgery (95% confidence interval minus 5.2 to 0.2; P=0.067; Supplemental Table 4). Missing scores would need to differ by 23 points between groups to favor surgery (Supplemental Figure 2). 😱 Very cool figure!

🥸 1️⃣7️⃣ In exploratory analyses (Table 4), only ejection fraction showed a significant interaction (P=0.027). Among 89 patients with values of 55% or lower, the score at 7 years was 8.1 points higher with transcatheter replacement (95% confidence interval minus 1.1 to 17.2).

🥸 1️⃣9️⃣ Subgroup findings need caution. Only 31 transcatheter and 15 surgical patients with ejection fraction of 55% or lower were analyzed at 7 years. The trial did not include patients younger than 65 years or with bicuspid valves, and results apply only to the SAPIEN 3 valve.

🥸 2️⃣0️⃣ In low risk patients with severe aortic stenosis, both treatments improved health status through 7 years. Transcatheter replacement gave faster recovery and a small advantage through 2 years. Scores were similar in years 3 through 7, and assessments continue to 10 years.