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AHRQ Research Studies Date
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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 12 of 12 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
Blumenthal-Barby JS, Kostick KM, Delgado ED
Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: implications for informed consent and shared decision-making.
The authors investigated the decision-making process and informational and decisional needs of patients and their caregivers regarding left ventricular assist device (LVAD) placement. They found that participants easily and clearly identified their values: life extension; family; and mobility. Participants reported the need to meet other patients and caregivers before device placement and to have an involved caregiver to synthesize information. They further found that some participants demonstrated a lack of clarity regarding transplant probability.
AHRQ-funded; HS024849.
Citation: Blumenthal-Barby JS, Kostick KM, Delgado ED .
Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: implications for informed consent and shared decision-making.
J Heart Lung Transplant 2015 Sep;34(9):1182-9. doi: 10.1016/j.healun.2015.03.026.
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Keywords: Caregiving, Shared Decision Making, Heart Disease and Health, Medical Devices, Patient and Family Engagement
Chen CY, Stevenson LW, Stewart GC
Real world effectiveness of primary implantable cardioverter defibrillators implanted during hospital admissions for exacerbation of heart failure or other acute co-morbidities: cohort study of older patients with heart failure.
The researchers examined the effectiveness of primary implantable cardioverter defibrillators (ICDs) in elderly patients receiving the device during a hospital admission for exacerbation of heart failure or other acute co-morbidities. They concluded that the benefits of primary ICD therapy seen in pivotal trials were not apparent in patients aged 66 or over who received ICDs during a hospital admission for exacerbation of heart failure or other acute co-morbidities.
AHRQ-funded; 290-2005-0016-I -TO3; HS017731.
Citation: Chen CY, Stevenson LW, Stewart GC .
Real world effectiveness of primary implantable cardioverter defibrillators implanted during hospital admissions for exacerbation of heart failure or other acute co-morbidities: cohort study of older patients with heart failure.
BMJ 2015 Jul 14;351:h3529. doi: 10.1136/bmj.h3529..
Keywords: Comparative Effectiveness, Elderly, Medical Devices, Heart Disease and Health, Outcomes
Pokorney SD, Miller AL, Chen AY
Implantable cardioverter-defibrillator use among Medicare patients with low ejection fraction after acute myocardial infarction.
This study examined Implantable Cardioverter-Defibrillator (ICD) implantation rates and associated mortality among older MI patients with low ejection fraction (EF). It found that fewer than 1 in 10 eligible patients with low EF received an ICD within 1 year after MI, although ICD implantation was associated with lower risk-adjusted mortality at 2 years.
AHRQ-funded; HS021092.
Citation: Pokorney SD, Miller AL, Chen AY .
Implantable cardioverter-defibrillator use among Medicare patients with low ejection fraction after acute myocardial infarction.
JAMA 2015 Jun 23-30;313(24):2433-40. doi: 10.1001/jama.2015.6409..
Keywords: Medical Devices, Heart Disease and Health, Medicare
Masoudi FA, Go AS, Magid DJ
Age and sex differences in long-term outcomes following implantable cardioverter-defibrillator placement in contemporary clinical practice: findings from the Cardiovascular Research Network.
The objectives of this study were to characterize the risks of adverse outcomes in women and older patients. following implantable cardioverter-defibrillator placement with a focus on death, hospitalization, and complications. It concluded that the burden of adverse outcomes is substantial and varies according to patient age and sex. These differences in outcome generally do not vary according to baseline heart failure characteristics.
AHRQ-funded; 290050033; HS019814.
Citation: Masoudi FA, Go AS, Magid DJ .
Age and sex differences in long-term outcomes following implantable cardioverter-defibrillator placement in contemporary clinical practice: findings from the Cardiovascular Research Network.
J Am Heart Assoc 2015 Jun 2;4(6):e002005. doi: 10.1161/jaha.115.002005..
Keywords: Medical Devices, Cardiovascular Conditions, Patient-Centered Outcomes Research, Elderly, Outcomes
Heidenreich PA, Tsai V, Bao H
Does age influence cardiac resynchronization therapy use and outcome?
This study sought to describe the use of cardiac resynchronization therapy with defibrillator (CRT-D) and its association with survival for older patients. It found that receipt of CRT-D was associated with better survival at 1 year (82.1 percent vs. 77.1 percent, respectively) and 4 years (54.0 percent vs. 46.2 percent , respectively) than in those receiving only an implantable cardiac defibrillator.
AHRQ-funded; HS019814.
Citation: Heidenreich PA, Tsai V, Bao H .
Does age influence cardiac resynchronization therapy use and outcome?
JACC Heart Fail 2015 Jun;3(6):497-504. doi: 10.1016/j.jchf.2015.01.012..
Keywords: Medical Devices, Cardiovascular Conditions, Heart Disease and Health, Elderly, Patient-Centered Outcomes Research
Walker J, Tucker LY, Goodney P
Adherence to endovascular aortic aneurysm repair device instructions for use guidelines has no impact on outcomes.
The authors reported on their long-term endovascular aortic aneurysm repair (EVAR) experience in a large multicenter registry with regard to adherence to instructions for use (IFU) guidelines. They found that overall mortality and aneurysm-related mortality were unaffected by IFU adherence, and that rates of endoleak and reintervention after initial EVAR were similar, suggesting that lack of IFU-based anatomic suitability was not a driver of outcomes.
AHRQ-funded; HS021581.
Citation: Walker J, Tucker LY, Goodney P .
Adherence to endovascular aortic aneurysm repair device instructions for use guidelines has no impact on outcomes.
J Vasc Surg 2015 May;61(5):1151-9. doi: 10.1016/j.jvs.2014.12.053.
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Keywords: Adverse Events, Guidelines, Medical Devices, Outcomes