Nobuhiro Handa1,2, Hiraku Kumamaru3, Kei Torikai4, Shun Kohsaka5, Morimasa Takayama6, Junjiro Kobayashi7, Hisao Ogawa8, Haruki Shirato1, Kensuke Ishii1, Kazuhisa Koike2, Yoshimasa Yokoyama1, Hiroaki Miyata3, Noboru Motomura9, Yoshiki Sawa4. 1. Office of Medical Devices, Pharmaceuticals and Medical Devices Agency. 2. Office of Safety, Pharmaceuticals and Medical Devices Agency. 3. Department of Healthcare Quality Assessment, Graduate School of Medicine, Faculty of Medicine, The University of Tokyo. 4. Department of Cardiovascular Surgery, Osaka University Hospital. 5. Department of Cardiology, School of Medicine, Keio University. 6. Department of Cardiology, Sakakibara Memorial Hospital. 7. Department of Cardiovascular Surgery, National Cerebral and Cardiovascular Center. 8. Department of Cardiology, National Cerebral and Cardiovascular Center. 9. Department of Cardiovascular Surgery, School of Medicine, Toho University Sakura Hospital.
Abstract
BACKGROUND: The introduction of transcatheter aortic valve implantation (TAVI) into Japan was strictly controlled to optimize patient outcomes. The goal of this study was to assess if increasing experience during the introduction of this procedure was associated with outcomes.Methods and Results: The initial 1,752 patients registered in the Japanese national TAVI registry were included in the study. The association between operator procedure number and incidence of the early safety endpoint at 30 days (ESE30) as defined in the Valve Academic Research Consortium-2 consensus document was evaluated. Patients were divided into 4 groups by quartiles of procedure count (Groups I-IV in order of increasing number of procedures). Median patient age was 85 years, and 30.5% were male. The 30-day mortality rate was 1.4% (n=24), and 78 patients (7.9%) experienced 95 ESE30. Among the variables included in the model, ESE30 was associated with non-transfemoral approach (P=0.004), renal dysfunction (Cr >2.0 mg/dL) (P=0.01) and NYHA class III/IV (P=0.04). ESE30 incidence was not significantly different between Groups I-III and Group IV. Spline plots demonstrated that experience of 15-20 cases in total was needed to achieve a consistent low risk of ESE30. CONCLUSIONS: Increasing experience was associated with better outcomes, but to a lesser degree than in previous reports. Our findings suggested that the risks associated with the learning curve process were appropriately mitigated.
BACKGROUND: The introduction of transcatheter aortic valve implantation (TAVI) into Japan was strictly controlled to optimize patient outcomes. The goal of this study was to assess if increasing experience during the introduction of this procedure was associated with outcomes.Methods and Results: The initial 1,752 patients registered in the Japanese national TAVI registry were included in the study. The association between operator procedure number and incidence of the early safety endpoint at 30 days (ESE30) as defined in the Valve Academic Research Consortium-2 consensus document was evaluated. Patients were divided into 4 groups by quartiles of procedure count (Groups I-IV in order of increasing number of procedures). Median patient age was 85 years, and 30.5% were male. The 30-day mortality rate was 1.4% (n=24), and 78 patients (7.9%) experienced 95 ESE30. Among the variables included in the model, ESE30 was associated with non-transfemoral approach (P=0.004), renal dysfunction (Cr >2.0 mg/dL) (P=0.01) and NYHA class III/IV (P=0.04). ESE30 incidence was not significantly different between Groups I-III and Group IV. Spline plots demonstrated that experience of 15-20 cases in total was needed to achieve a consistent low risk of ESE30. CONCLUSIONS: Increasing experience was associated with better outcomes, but to a lesser degree than in previous reports. Our findings suggested that the risks associated with the learning curve process were appropriately mitigated.
Entities:
Keywords:
Learning curve assessment; National registry; Transcatheter aortic valve replacement