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

Document Type

Article

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.

Medical Subject Headings

Adolescent; Adult; Aged; Aged, 80 and over; Cardiac Catheterization (adverse effects, instrumentation, mortality, trends); Databases, Factual; Device Approval; Female; Heart Valve Prosthesis (trends); Heart Valve Prosthesis Implantation (adverse effects, instrumentation, mortality, trends); Hospital Mortality (trends); Hospitals, High-Volume (trends); Hospitals, Low-Volume (trends); Humans; Male; Middle Aged; Mitral Valve (diagnostic imaging, physiopathology, surgery); Patient Readmission (trends); Postoperative Complications (diagnosis, epidemiology, mortality, therapy); Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States (epidemiology); United States Food and Drug Administration; Young Adult

Publication Date

5-1-2018

Publication Title

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

E-ISSN

1522-726X

Volume

91

Issue

6

First Page

1171

Last Page

1181

PubMed ID

29152829

Digital Object Identifier (DOI)

10.1002/ccd.27366

Link to Full Text

Share

COinS