BACKGROUND: There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip® . Whether a complex new technology can be disseminated safely and quickly is controversial. METHODS: The study cohort was derived from the National Readmission Data (NRD) 2013-14. MitraClip® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The primary outcome was a composite of in-hospital mortality + procedural complications. Secondary outcome included 30-day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes. RESULTS: Our analysis included 2003 MitraClip® procedures. Overall in-hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post-FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in-hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in-hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30-day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in-hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures. CONCLUSION: A significant increase in MitraClip® procedural volumes occurred post-FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.
BACKGROUND: There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip® . Whether a complex new technology can be disseminated safely and quickly is controversial. METHODS: The study cohort was derived from the National Readmission Data (NRD) 2013-14. MitraClip® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The primary outcome was a composite of in-hospital mortality + procedural complications. Secondary outcome included 30-day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes. RESULTS: Our analysis included 2003 MitraClip® procedures. Overall in-hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post-FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in-hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in-hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30-day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in-hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures. CONCLUSION: A significant increase in MitraClip® procedural volumes occurred post-FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.
Authors: Elizabeth M Perpetua; Kimberly A Guibone; Patricia A Keegan; Roseanne Palmer; Martina K Speight; Kornelija Jagnic; Joan Michaels; Rosemarie A Nguyen; Emily S Pickett; Dianna Ramsey; Susan J Schnell; Shing-Chiu Wong; Mark Reisman Journal: Struct Heart Date: 2022-03-21
Authors: Mohammed Osman; Muhammad Zia Khan; Peter D Farjo; Muhammad U Khan; Safi U Khan; Mina M Benjamin; Muhammad Bilal Munir; Sudarshan Balla Journal: Catheter Cardiovasc Interv Date: 2020-05-06 Impact factor: 2.692