Journal article
Procedural trends, outcomes, and readmission rates pre-and post-FDA approval for MitraClip from the National Readmission Database (2013-14)
Catheterization and cardiovascular interventions, Vol.91(6), pp.1171-1181
05/01/2018
DOI: 10.1002/ccd.27366
PMID: 29152829
Abstract
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.
Details
- Title: Subtitle
- Procedural trends, outcomes, and readmission rates pre-and post-FDA approval for MitraClip from the National Readmission Database (2013-14)
- Creators
- Sidakpal S Panaich - Department of Cardiovascular Diseases; Mayo Clinic; Rochester MinnesotaShilpkumar Arora - Department of Cardiology, Mount Sinai St Luke's Roosevelt Hospital Center; New YorkApurva Badheka - Department of Cardiology, The Everett Clinic; Everett WashingtonVarun Kumar - Department of Cardiology, Mount Sinai St Luke's Roosevelt Hospital Center; New YorkElad Maor - Department of Cardiovascular Diseases; Mayo Clinic; Rochester MinnesotaClaire Raphael - Department of Cardiovascular Diseases; Mayo Clinic; Rochester MinnesotaAbhishek Deshmukh - Department of Cardiovascular Diseases; Mayo Clinic; Rochester MinnesotaGuy Reeder - Department of Cardiovascular Diseases; Mayo Clinic; Rochester MinnesotaMackram Eleid - Department of Cardiovascular Diseases; Mayo Clinic; Rochester MinnesotaCharanjit S Rihal - Department of Cardiovascular Diseases; Mayo Clinic; Rochester Minnesota
- Resource Type
- Journal article
- Publication Details
- Catheterization and cardiovascular interventions, Vol.91(6), pp.1171-1181
- DOI
- 10.1002/ccd.27366
- PMID
- 29152829
- ISSN
- 1522-1946
- eISSN
- 1522-726X
- Language
- English
- Date published
- 05/01/2018
- Academic Unit
- Cardiovascular Medicine; Internal Medicine
- Record Identifier
- 9984094533302771
Metrics
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