Cardiac Resynchronization Therapy in Older Patients: Age Is Just a Number, and Yet …

Kramer, Daniel B.; Steinhaus, Daniel A.

doi:10.1016/j.cardfail.2016.10.006

Cited by 3 publications

(3 citation statements)

References 20 publications

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“…These include echocardiographic parameters, QRS morphology and duration, renal function, and more nuanced clinical details, such as frailty. 20 Our logistic model, adjusting for known confounders, showed that 1-year mortality favored CRT-D recipients, but with evidence of residual confounding that is likely endemic to traditional comparative effectiveness assessments of CRT and ICDs. By contrast, we used the large variation among facilities in their use of CRT-P (versus CRT-D) devices, after controlling for patient characteristics, to construct an IV approach to estimate less-biased outcome comparisons among much larger numbers of patients than have been enrolled in clinical trials.…”

Section: Discussionmentioning

confidence: 81%

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Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator

Kramer

Normand

Volya

et al. 2018

Circ: Cardiovascular Quality and Outcomes

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BACKGROUND: Little is Known about real-world facility-level preferences for cardiac resynchronization therapy devices with (CRT-D) and without (CRT-D) defibrillator backup. We quantify this variation at the facility level and exploit this variation to compare outcomes of patients receiving these 2 devices. METHODS AND RESULTS: Claims data from fee-for-service Medicare beneficiaries were used to identify new CRT-P and CRT-D implants, 2006 to 2012. We modeled factors associated with receipt of each device, and compared mortality, hospitalizations, and reoperations for patients receiving each using both logistic regression and instrumental variable analysis to account for confounding. Among 71 459 device recipients (CRT-P, 11 925; CRT-D, 59 534; 31% women), CRT-P recipients were older, more likely to be women, and had more comorbidities. Variation in device selection among facilities was substantial: After adjustment for patient characteristics, the odds of receiving a CRT-P (versus CRT-D) device were 7.6× higher for a patient treated at a facility in the highest CRT-P use quartile versus a facility in the lowest CRT-P use quartile. Logistic modeling suggested a survival advantage for CRT-D devices but with falsification end points indicating residual confounding. By contrast, in the instrumental variable analysis using facility variability as the proposed instrument, clinical characteristics and falsification end points were well balanced, and 1-year mortality in patients who received CRT-P versus CRT-D implants did not differ, while CRT-P patients had a lower probability of hospitalizations and reoperations in the year following implant. CONCLUSIONS: CRT-P versus CRT-D selection varies substantially among facilities, adjusted for clinical factors. After instrumental variable adjustment for clinical covariates and facility preference, survival was no different between the devices. Therefore, CRT-P may be preferred for Medicare beneficiaries considering new CRT implantation.

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Section: Discussionmentioning

confidence: 81%

“…From these findings, the authors concluded that CRT-D may have little practical value compared with CRT-P given the low incidence of arrhythmic death in older patients. 20…”

Section: Discussionmentioning

confidence: 99%

Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator

Kramer

Normand

Volya

et al. 2018

Circ: Cardiovascular Quality and Outcomes

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“…26 But this permissive approach may not serve either patients' or CMS' interests well, as it is not at all clear that cardiac resynchronization therapy (particularly when paired with defibrillator back-up) actually improves outcomes meaningfully for older patients. 27 If CMS, working with manufactur-ers early in the investigative process, had made it clear that high-quality evidence specific to older patients would be necessary for coverage of cardiac resynchronization therapy, clinical trials might have been redesigned accordingly. Ideally, parallel review would encourage exactly these study refinements rather than a calculated assumption that a new device or labeling will not be met with sufficient skepticism to merit a restrictive NCD.…”

Section: Approval and Coverage Of Medical Devices In The Usmentioning

confidence: 99%

Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway

Holtzman¹,

Kramer²

2018

J. Law. Med. Ethics

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Mandates for Shared Decisions: Means to which Ends?

Kramer¹

2021

J. Law. Med. Ethics

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Cardiac Resynchronization Therapy in Older Patients: Age Is Just a Number, and Yet …

Cited by 3 publications

References 20 publications

Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator

Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator

Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway

Mandates for Shared Decisions: Means to which Ends?

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