Transcatheter versus surgical aortic valve replacement in aortic stenosis patients requiring mechanical circulation support: a nationwide Japanese study

Abstract Introduction Transcatheter aortic valve replacement (TAVR) has demonstrated comparable clinical outcomes to surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS). However, previous trials excluded patients who had required mechanical circulatory support (MCS) for cardiogenic shock. Thus, the clinical feature of aortic valve replacement requiring MCS and the efficacy of TAVR compared to SAVR has not been fully exhibited in AS patients. Purpose This study investigated the demography and clinical outcomes comparing TAVR and SAVR for AS demanding MCS. Methods The current study was an observational retrospective study using Japanese nationwide data from the Japanese Registry Of All cardiac and vascular Diseases-Diagnostic Procedure Combination (JROAD-DPC). Between April 1, 2012, and March 31, 2022, AS patients undergoing TAVR or SAVR who required MCS were evaluated. The primary outcome was 30-day mortality. In addition, we assessed ischemic stroke, hemorrhagic stroke during hospitalization. Result During the period, 80,752 patients (TAVR=36,546 and SAVR=44,206) were identified. The frequency of MCS (intra-aortic balloon pumping and/or extracorporeal membrane oxygenation) was 3.0% (1,097 patients) of the TAVR group and 4.8% (2,133 patients) of the SAVR group. In the TAVR group, 78% of patients were implanted balloon-expandable valve and 7.1% of patients were transapical apical approach. TAVR was performed in older (median age: 85 years vs. 76 years, p<0.001), lower body mass index (BMI) (median BMI: 21.5 kg/m2 vs. 22.7 kg/m2, p<0.001), and more female patients (42% vs. 27%, p<0.001) than SAVR. The 30-day mortality was lower in TAVR than SAVR (12% in TAVR and 19% in SAVR, p<0.001) (Figure). After adjusting age, gender, TAVR was significantly associated with decreased 30-day mortality compared to SAVR (adjusted HR 0.52 (0.41–0.67), p<0.001). In contrast, the incidence of ischemic stroke and hemorrhagic stroke were comparable in 2 groups (ischemic stroke; 4.2% in TAVR vs. 4.1% in SAVR, p=0.93 and hemorrhagic stroke; 0.3% vs. 0.3%, respectively). Conclusion According to nationwide real-world clinical data on aortic valve replacement for AS, the frequency of patients requiring MCS due to cardiogenic shock was 3.0% in the TAVR group and 4.8% in the SAVR group. Our findings demonstrated short-term outcomes following TAVR for patients requiring MCS for cardiogenic shock was better than those following SAVR.