Transcatheter Mitral Valve Therapy in the United States: A Report from the STS/ACC TVT Registry.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

Transcatheter Mitral Valve Therapy in the United States: A Report From the STS-ACC TVT Registry.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

Frailty Phenotype and Deficit Accumulation Frailty Index in Predicting Recovery After Transcatheter and Surgical Aortic Valve Replacement.

BACKGROUND: Frailty phenotype and deficit-accumulation frailty index (FI) are widely used measures of frailty. Their performance in predicting recovery after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) has not been compared. METHODS: Patients undergoing SAVR (n = 91) or TAVR (n = 137) at an academic medical center were prospectively assessed for frailty phenotype and FI. Outcomes were death or poor recovery, defined as a decline in ability to perform 22 daily activities and New York Heart Association class 3 or 4 at 6 months after surgery. The predictive ability of frailty phenotype versus FI and their additive value to a traditional surgical risk model were evaluated using C-statistics, net reclassification improvement (NRI), and integrated discrimination improvement. RESULTS: TAVR patients had higher prevalence of phenotypic frailty (85% vs 38%, p < .001) and greater mean FI (0.37 vs 0.24, p < .001) than SAVR patients. In the overall cohort, FI had a higher C-statistic than frailty phenotype (0.74 vs 0.63, p = .01) for predicting death or poor recovery. Adding FI to the traditional model improved prediction (NRI, 26.4%, p = .02; integrated discrimination improvement, 7.7%, p < .001), while adding phenotypic frailty did not (NRI, 4.0%, p = .70; integrated discrimination improvement, 1.6%, p = .08). The additive value of FI was evident in TAVR patients (NRI, 42.8%, p < .01) but not in SAVR patients (NRI, 25.0%, p = .29). Phenotypic frailty did not add significantly in either TAVR (NRI, 6.8%, p = .26) or SAVR patients (NRI, 25.0%, p = .29). CONCLUSIONS: Deficit-accumulation FI provides better prediction of death or poor recovery than frailty phenotype in older patients undergoing SAVR and TAVR.