Procedural trends, outcomes, and readmission rates pre-and post-FDA approval for MitraClip from the National Readmission Database (2013–14)

Sidakpal S. Panaich*, Shilpkumar Arora, Apurva Badheka, Varun Kumar, Elad Maor, Claire Raphael, Abhishek Deshmukh, Guy Reeder, Mackram Eleid, Charanjit S. Rihal

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1171-1181
Number of pages11
JournalCatheterization and Cardiovascular Interventions
Volume91
Issue number6
DOIs
StatePublished - 1 May 2018
Externally publishedYes

Funding

FundersFunder number
Agency for Healthcare Research and Quality

    Keywords

    • hospital volume
    • in hospital mortality
    • mitra clip
    • readmission

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