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Research Studies is a monthly compilation of research articles funded by AHRQ or authored by AHRQ researchers and recently published in journals or newsletters.
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1 to 6 of 6 Research Studies DisplayedDhruva SS, Ross JS, Schulz WL
Fulfilling the promise of unique device identifiers.
This article discusses unique device identifiers (UDIs). Unique device identifiers must be applied to implanted devices, such as pacemakers and artificial hips, and most invasive devices, such as robotic surgical instruments. The authors indicate that the UDI has had limited effect because it is available in neither electronic health records (EHRs) nor administrative claims data. As such, medical devices cannot be easily identified, tracked, or associated with patients, preventing population-level analyses of their safety and effectiveness.
AHRQ-funded; HS022882; HS025164.
Citation: Dhruva SS, Ross JS, Schulz WL .
Fulfilling the promise of unique device identifiers.
Ann Intern Med 2018 Aug 7;169(3):183-85. doi: 10.7326/m18-0526..
Keywords: Medical Devices
Bates J, Parzynski CS, Dhruva SS
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: a case study of implantable cardioverter defibrillators.
The purpose of this study was to estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. The investigators concluded that small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates.
AHRQ-funded; HS022882.
Citation: Bates J, Parzynski CS, Dhruva SS .
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: a case study of implantable cardioverter defibrillators.
Pharmacoepidemiol Drug Saf 2018 Aug;27(8):848-56. doi: 10.1002/pds.4565..
Keywords: Cardiovascular Conditions, Heart Disease and Health, Medical Devices, Patient Safety, Registries, Surgery
Patel S, Poorjary P, Pawar S
National landscape of unplanned 30-day readmissions in patients with left ventricular assist device implantation.
This study tracked unplanned 30-day readmissions in patients who had undergone left ventricular assist device (LVAD) implantation during 2013. Data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database was used. Out of 2,235 patients who had an LVAD implantation, 29.7% had at least 1 unplanned readmission within 30 days. The top reasons for readmission were implant complications (14.9%), congestive heart failure (11.7%), and gastrointestinal bleeding (8.4%). Predictors of readmission included a prolonged length stay during the primary admission, Medicare insurance, and discharge to a short-term facility.
AHRQ-funded; HS023000.
Citation: Patel S, Poorjary P, Pawar S .
National landscape of unplanned 30-day readmissions in patients with left ventricular assist device implantation.
Am J Cardiol 2018 Jul 15;122(2):261-67. doi: 10.1016/j.amjcard.2018.03.363..
Keywords: Healthcare Cost and Utilization Project (HCUP), Heart Disease and Health, Cardiovascular Conditions, Surgery, Medical Devices, Adverse Events
Desai NR, Bourdillon PM, Parzynski CS
Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and
The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria. To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals).
AHRQ-funded; HS023000.
Citation: Desai NR, Bourdillon PM, Parzynski CS .
Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and
JAMA 2018 Jul 3;320(1):63-71. doi: 10.1001/jama.2018.8151..
Keywords: Cardiovascular Conditions, Medical Devices, Medical Devices, Medicare, Policy
Sharma A, Al-Khatib SM, Ezekowitz JA
Implantable cardioverter-defibrillators in heart failure patients with reduced ejection fraction and diabetes.
This study evaluates the effectiveness of a strategy that uses an implantable cardioverter-defibrillator (ICD) plus medical therapy versus medical therapy alone among patients with heart failure (HF) and diabetes. Researchers conducted a patient-level combined-analysis using a combined dataset that included four primary prevention ICD trials of patients with HF or severely reduced ejection fractions. The results indicate that primary prevention ICD in combination with medical therapy versus medical therapy alone was not significantly associated with a reduced risk of all-cause death. The authors conclude that further studies are needed to evaluate the effectiveness of ICDs among patients with diabetes.
AHRQ-funded; HS018505.
Citation: Sharma A, Al-Khatib SM, Ezekowitz JA .
Implantable cardioverter-defibrillators in heart failure patients with reduced ejection fraction and diabetes.
Eur J Heart Fail 2018 Jun;20(6):1031-38. doi: 10.1002/ejhf.1192..
Keywords: Cardiovascular Conditions, Comparative Effectiveness, Diabetes, Heart Disease and Health, Medical Devices, Prevention
Bachmann JM, Duncan MS, Shah AS
Association of cardiac rehabilitation with decreased hospitalizations and mortality after ventricular assist device implantation.
This study examined whether outcomes of cardiac patients who had received ventricular assist device (VAD) implementation had decreased hospitalization and mortality with cardiac rehabilitation (CR). Medicare beneficiaries enrolled for disability or aged 65 years and older in 2014 were included. The investigators identified VAD recipients by diagnosis codes. It was found that each 5-year increase in age was associated with attending an additional 1.6 CR sessions and there was a 23% lower 1-year hospitalization risk and a 47% lower 1-year mortality risk.
AHRQ-funded; HS022990.
Citation: Bachmann JM, Duncan MS, Shah AS .
Association of cardiac rehabilitation with decreased hospitalizations and mortality after ventricular assist device implantation.
JACC Heart Fail 2018 Feb;6(2):130-39. doi: 10.1016/j.jchf.2017.11.002..
Keywords: Cardiovascular Conditions, Rehabilitation, Heart Disease and Health, Medical Devices, Surgery, Patient-Centered Outcomes Research, Outcomes, Mortality, Evidence-Based Practice, Hospitalization
