Learning curve for transcatheter aortic valve replacement for native aortic regurgitation: Safety and technical performance study

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a fundamentally new procedure for the treatment of native aortic regurgitation (AR). The number of cases needed to gain proficiency with the procedure is unknown. HYPOTHESIS: This study aimed to evaluate the learning curve for TAVR for native AR. METHODS: This study retrospectively reviewed a prospective database from 134 consecutive native AR patients who underwent the J-valve TAVR system, which performed by a single team interventional cardiologist. The cumulative sum (CUSUM) method was used to analyze the learning curve. Patients were divided into two groups in chronological order, defined by the surgeon's early (group 1: the first 52 cases) and skilled (group 2: the next 82 cases) experience. Demographic data, intraoperative characteristics, and short-term surgical outcomes were compared between the two groups. RESULTS: CUSUM plots revealed decreasing procedure time and fluoroscopy time after patients 52 and 43, respectively. The patient date consistently demonstrated that high-risk scores and major perioperative parameters were comparable between the two groups. The use of contrast dye (group 1, 94.22 ± 30.07 mL; group 2, 70.43 ± 15.02 mL, P<.05), total procedure time (group 1, 84.96 ± 17.76 minutes; group 2, 59.95 ± 12.83 minutes, P<.05), and fluoroscopy time (group 1, 11.52 ± 3.81 minutes; group 2, 6.47 ± 1.53 minutes, P<.05) were significantly reduced in group 2. The overall device success rate in group 1 was 96.2% vs 96.3% in group 2 and remained high (P = 1.0). The overall 30-day mortality was 3.8% in group 2 (group 1, 0 to group 2, 3.8%; P = .16). The complications rate, such as pulmonary hypertension, chronic kidney disease, and coronary artery disease were higher in group 2. CONCLUSIONS: For a surgeon without previous TAVR experience, 52 cases of performance is the minimal requirement to gain the proficiency of TAVR for native AR. The skilled surgeons have been observed with reduced procedural time, fluoroscopy times, radiation exposure dose, and contrast volume usage. However, the overall prognosis was not significantly different between the two groups.