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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
Results
1 to 13 of 13 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
Chrisinger BW, Grossestreuer AV, Laguna MC
Characteristics of automated external defibrillator coverage in Philadelphia, PA, based on land use and estimated risk.
The authors investigated how well the likelihood of out-of-hospital cardiac arrest was met by the supply of automated external defibrillators (AED) in a dense urban environment. This article offers one method by which local officials can use spatial data to prioritize attention for AED placement and coverage.
AHRQ-funded; HS018362.
Citation: Chrisinger BW, Grossestreuer AV, Laguna MC .
Characteristics of automated external defibrillator coverage in Philadelphia, PA, based on land use and estimated risk.
Resuscitation 2016 Dec;109:9-15. doi: 10.1016/j.resuscitation.2016.09.021.
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Keywords: Medical Devices, Health Insurance, Urban Health, Cardiovascular Conditions
Krishnamurthy Y, Cooper LB, Parikh KS
Pulmonary hypertension in the era of mechanical circulatory support.
The researchers summarized the literature available to highlight the definition, pathogenesis, and prognosis of pulmonary hypertension (PH) due to left heart disease (LHD). Additionally, they discussed the use of mechanical circulatory support (MCS) in this population. Then, they provided recommendations regarding the management and reassessment of PH due to LHD in the specific context of MCS.
AHRQ-funded; HS021092.
Citation: Krishnamurthy Y, Cooper LB, Parikh KS .
Pulmonary hypertension in the era of mechanical circulatory support.
ASAIO J 2016 Sep-Oct;62(5):505-12. doi: 10.1097/mat.0000000000000408.
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Keywords: Comparative Effectiveness, Heart Disease and Health, Medical Devices, Respiratory Conditions
Khazanie P, Hammill BG, Patel CB
Use of heart failure medical therapies among patients with left ventricular assist devices: insights from INTERMACS.
The authors examined the use of heart failure medications before and after left ventricular assist devices (LVAD) implant in adult patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). They found that overall use of neurohormonal antagonists was low after LVAD implant, whereas use of loop diuretics and amiodarone remained high, and concluded that heart failure medication use is highly variable, but appears to generally increase after LVAD implantation.
AHRQ-funded; HS021092.
Citation: Khazanie P, Hammill BG, Patel CB .
Use of heart failure medical therapies among patients with left ventricular assist devices: insights from INTERMACS.
J Card Fail 2016 Sep;22(9):672-9. doi: 10.1016/j.cardfail.2016.02.004.
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Keywords: Comparative Effectiveness, Heart Disease and Health, Medical Devices, Medication, Patient-Centered Outcomes Research
Kostick KM, Minard CG, Wilhelms LA
Development and validation of a patient-centered knowledge scale for left ventricular assist device placement.
The authors presented a comprehensive and valid methodology for developing a clinically informed and patient-centered measure of knowledge about left ventricular assist device (LVAD) therapy to facilitate discussion and measure candidate understanding of treatment options. They concluded that the LVAD knowledge scale may be useful in clinical settings to identify gaps in knowledge among patient candidates considering LVAD treatment; to better tailor education and discussion with patients and their caregivers; and to enhance informed decision-making before treatment decisions are made.
AHRQ-funded; HS024849.
Citation: Kostick KM, Minard CG, Wilhelms LA .
Development and validation of a patient-centered knowledge scale for left ventricular assist device placement.
J Heart Lung Transplant 2016 Jun;35(6):768-76. doi: 10.1016/j.healun.2016.01.015.
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Keywords: Decision Making, Heart Disease and Health, Medical Devices, Patient and Family Engagement, Patient-Centered Outcomes Research
Zhu Y, Chen CY, Matsuyama Y
Comparative validity of methods to select appropriate cutoff weight for probabilistic linkage without unique personal identifiers.
The researchers aimed to assess the validity of probabilistic linkage in the absence of unique personal identifiers (UPI) and the methods of cutoff weight selection. They found that probabilistic linkage without UPI generated valid linkages when an optimal cutoff was chosen and concluded that histogram inspection, the duplicate method, and the odds formula method can be used in conjunction when a gold standard is not available.
AHRQ-funded; 29020050016I.
Citation: Zhu Y, Chen CY, Matsuyama Y .
Comparative validity of methods to select appropriate cutoff weight for probabilistic linkage without unique personal identifiers.
Pharmacoepidemiol Drug Saf 2016 Apr;25(4):444-52. doi: 10.1002/pds.3832.
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Keywords: Data, Medical Devices, Registries
Zeitler EP, Hellkamp AS, Schulte PJ
Comparative effectiveness of implantable cardioverter defibrillators for primary prevention in women.
The researchers examined clinical practice data to compare survival rates among women with heart failure with or without a primary prevention implantable cardioverter defibrillator (ICD). Theyn found that among patients with heart failure with reduced left ventricular ejection fraction, a primary prevention ICD was associated with a significant survival advantage among women and among men.
AHRQ-funded; HS021092.
Citation: Zeitler EP, Hellkamp AS, Schulte PJ .
Comparative effectiveness of implantable cardioverter defibrillators for primary prevention in women.
Circ Heart Fail 2016 Jan;9(1):e002630. doi: 10.1161/circheartfailure.115.002630.
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Keywords: Medical Devices, Comparative Effectiveness, Prevention, Heart Disease and Health, Mortality
Green AR, Leff B, Wang Y
Geriatric conditions in patients undergoing defibrillator implantation for prevention of sudden cardiac death: prevalence and impact on mortality.
The researchers sought to determine the prevalence of frailty and dementia among older adults receiving primary prevention implantable cardioverter-defibrillators (ICDs) and to determine the impact of multimorbidity on mortality within 1 year of ICD implantation. They concluded that more than 10 percent of Medicare beneficiaries with heart failure receiving primary prevention ICDs have frailty or dementia. These patients had significantly higher 1-year mortality than those with other common chronic conditions.
AHRQ-funded; HS019814; 290201200007I.
Citation: Green AR, Leff B, Wang Y .
Geriatric conditions in patients undergoing defibrillator implantation for prevention of sudden cardiac death: prevalence and impact on mortality.
Circ Cardiovasc Qual Outcomes 2016 Jan;9(1):23-30. doi: 10.1161/circoutcomes.115.002053.
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Keywords: Elderly, Medical Devices, Mortality, Prevention, Dementia