1Deutsches Herzzentrum der Charité (CBF) Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland; 2Deutsches Herzzentrum der Charité (CCM) Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland; 3Deutsches Herzzentrum der Charité (CVK) Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland
Background: The domain of transcatheter edge-to-edge repair (TEER) for mitral regurgitation has been rapidly progressing. The MitraClip® system underwent stepwise improvements between 2016 and 2019 (second to fourth generation). However, real-world data on peri-procedural outcomes are still limited. We sought to analyze outcomes on procedural healthcare resource utilization and safety of TEER with the MitraClip® system in adult patient in the United States between 2016 and 2019.
Methods: Data were retrieved from the Healthcare Quality and Utilization Project National Inpatient Sample, which is an all-payer database of inpatient stays in the US that is made available by the Agency for Healthcare Research and Quality. Primary outcomes (healthcare resource utilization) were defined as hospital length of stay (LOS), adverse discharge disposition to a short-term hospital or skilled nursing facility and hospital costs. Secondary outcomes (safety) were in-hospital mortality and post-procedural complications. Negative binomial and logistic regression models were used to analyze outcomes by adjusting for 13 confounders.
Results: 5,212 adult patients underwent mitral TEER. The population was characterized by an average age of 77.7 years (±10.1) with 3,645 patients (69.9%) being above the age of 75 years, average Charlson Comorbidity Index of 3 [IQR 1-4], average number of cardiovascular risk factors of 3 [2-4], average CHA2DS2-VASc score of 4 [3-5] and average simplified HAS-BLED score of 2 [2-3]. Procedures were predominantly performed in large hospitals with 3,959 cases (76.0%), as well as in regional “hubs” at both US coastal regions. Between 2016 and 2019, hospital LOS decreased by 17% [95% Confidence Interval (CI) 0.78-0.88], adverse discharge rates by 41% [95% CI 0.45-0.78] and hospital costs by 8% [95% CI 0.88-0.95] (see Figure). Mitral TEER procedure showed save outcomes: vascular complications, ischemic strokes, cardiac arrests and cardiac tamponades with <1% each; 85 (1.6%) deaths, 171 (3.3%) post-procedural bleedings and 236 (4.5%) cardiogenic shocks. The composite outcome across all safety endpoints was decreased by 27% [95% CI 0.59-0.91] during the study period (see Figure). There was a linear increase in all adverse outcomes with increasing patient comorbidity level (P for trend <0.001).
Conclusion: Mitral TEER has become a safer and more efficient procedure with improving technologies, operator skills and centralized care despite a frail patient population. Careful considerations should be taken when performing the procedure in patients with multiple comorbidities.