Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Severe mitral regurgitation post-MitraClip (n=418). Intervention: Medicare administrative claims for event ascertainment vs. Physician-triggered event adjudication. Primary outcome: 1-year cumulative incidence of mortality.

Angela Lowenstern; Steven Lippmann; James M. Brennan; Tracy Y. Wang; Lesley H. Curtis; Ted Feldman; Donald D. Glower; Bradley G. Hammill; Sreekanth Vemulapalli

doi:10.1161/circinterventions.118.007451

May 1, 2019Circulation Cardiovascular InterventionsOpen Access

Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair

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Key result

Medicare claims reliably capture 1-year mortality and HF hospitalizations but overestimate bleeding and renal events.

n=418

Why the study?

Little was known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for adverse event ascertainment in structural heart disease studies.

Does administrative claims data accurately identify adverse clinical outcomes compared to clinician-triggered event adjudication in patients undergoing transcatheter mitral valve repair?

Key Points

To assess the comparative performance of Medicare administrative claims versus physician-adjudicated registry data for detecting adverse clinical events after transcatheter mitral valve repair.
Linked Medicare claims to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation between 2007 and 2013 in the EVEREST II High-Risk Registry or REALISM Continued-Access Registry.
Evaluated 1-year concordance between claims-based definitions and physician adjudication for mortality, heart failure hospitalization, renal failure, ventilation >48 hours, bleeding/transfusion, and mitral valve reintervention using event occurrence, cumulative incidence, and event synchrony.
Positive predictive value (PPV) of claims versus adjudication was highest for mortality (PPV=97%) and heart failure hospitalization (PPV=69%), but lower for bleeding (PPV=40%) and renal failure (PPV=19%).
One-year claims-based cumulative incidence was consistent with physician adjudication for mortality (21.8% vs. 21.1%) and primary-diagnosis heart failure hospitalization (17.1% vs. 15.9%), but claims substantially exceeded adjudication for bleeding (22.2% to 40.2% vs. 11.8%) and ventilation (5.6% vs. 2.9%).
Claims identified mitral valve reinterventions with perfect sensitivity and specificity relative to adjudication, and more than 75% of events captured in both datasets matched the exact calendar date.

Study Design

Type

Observational (n=418)

Multicenter

Yes

Structured PICO

Does administrative claims data accurately identify adverse clinical outcomes compared to clinician-triggered event adjudication in patients undergoing transcatheter mitral valve repair?

P

Population

418 older adults (aged ≥65 years) with severe mitral regurgitation who underwent transcatheter mitral valve repair, followed for 1 year to evaluate the concordance of adverse event ascertainment between Medicare claims and physician adjudication.

E

Exposure

Ascertainment of adverse events using administrative Medicare claims data

C

Comparator

Clinician-triggered event adjudication

O

Outcome

Concordance of claims-based outcomes with adjudicated events (mortality, heart failure hospitalization, renal failure, ventilation, and bleeding/transfusion) within 1 year

Main Result

Absolute Event Rate: 21.8% vs 21.1%

Administrative claims data showed high concordance with physician adjudication for mortality and heart failure hospitalization, but lower concordance for bleeding and renal failure.

Limitations

Medicare data linkage was only available for fee-for-service patients aged >65 years, excluding younger patients and those on managed care plans.
The small sample size and Medicare reporting rules prevented the analysis of events numbering 10 or fewer (e.g., 30-day non-fatal events).
The physician adjudication definitions predated the standardized MVARC criteria for structural heart disease.
The study utilized older ICD-9 billing codes, and results may vary with current ICD-10 coding practices.

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Implication

Claims data may overestimate bleeding and renal failure post-mitral repair; leaves open their accuracy for these outcomes while supporting validation for mortality and HF hospitalization.

Abstract

BACKGROUND: Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies. METHODS AND RESULTS: Medicare claims were linked to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation from 2007 to 2013 as part of the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) High-Risk Registry or the REALISM (Real World Expanded Multicenter Study of the MitraClip System) Continued-Access Registry. Each registry adjudicated mortality, heart failure hospitalization, renal failure, ventilation, and bleeding/transfusion within 1 year. Concordance of claims-based outcomes with events was assessed in 3 ways: 1-year occurrence, cumulative incidence, and synchrony of first events. For event occurrence, positive predictive value (PPV) of claims versus adjudication was the highest for mortality (PPV=97%) and heart failure hospitalization (PPV=69%) but lower for bleeding (PPV=40%) and renal failure (PPV=19%). Whereas claims-based cumulative incidence for mortality, heart failure hospitalization, and renal failure were consistent with clinician-triggered adjudication, incidence curves for bleeding events and ventilation diverged, with claims identifying a greater number of events. When events were detected by both methods, however, over 75% of event dates matched exactly. Mitral valve reinterventions were identified through claims with perfect sensitivity and specificity relative to physician adjudication. CONCLUSIONS: Ascertainment of mortality, heart failure hospitalization, and renal failure was highly concordant between physician adjudication and administrative claims. Further work is necessary to determine the role of administrative claims in event ascertainment in both prospective and retrospective studies of structural heart disease.

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Cite This Study

Lowenstern et al. (2019) conducted an observational in Severe mitral regurgitation post-MitraClip (n=418). Medicare administrative claims for event ascertainment vs. Physician-triggered event adjudication was evaluated on 1-year cumulative incidence of mortality. Medicare administrative claims demonstrated high concordance with physician adjudication for ascertaining 1-year mortality (21.8% vs. 21.1%) and heart failure hospitalizations (PPV 69%), but significantly overestimated the incidence of bleeding and renal failure events.

synapsesocial.com/papers/6a22227b3081c2f8f8e2471f https://doi.org/10.1161/circinterventions.118.007451

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Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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