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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 9 of 9 Research Studies DisplayedMentias A, Briasoulis A, Vaughan Sarrazin MS
Trends, perioperative adverse events, and survival of patients with left ventricular assist devices undergoing noncardiac surgery.
This longitudinal cohort study examined outcomes of noncardiac surgery (NCS) in patients with left ventricular assist devices (LVADs). This study examined patients enrolled in Medicare who had undergone durable LVAD implantation from January 2012 to November 2017 with follow-up through December 2017. Primary outcome after NCS was major adverse cardiovascular events (MACEs), defined as in-hospital or 30-day all-cause mortality, ischemic stroke, or intracerebral hemorrhage. Of the 8118 patients with LVAD, 1326 underwent NCS with 75.4% emergent or urgent, and 24.6% elective. Both elective and urgent or emergent NCS was associated with higher mortality early and late compared with patients with LVAD who did not undergo NCS.
AHRQ-funded; HS023104.
Citation: Mentias A, Briasoulis A, Vaughan Sarrazin MS .
Trends, perioperative adverse events, and survival of patients with left ventricular assist devices undergoing noncardiac surgery.
JAMA Netw Open 2020 Nov 2;3(11):e2025118. doi: 10.1001/jamanetworkopen.2020.25118..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Surgery, Medical Devices, Chronic Conditions, Outcomes, Adverse Events
Dhruva SS, Ross JS, Mortazavi BJ
Association of use of an intravascular microaxial left ventricular assist device vs intra-aortic balloon pump with in-hospital mortality and major bleeding among patients with acute myocardial infarction complicated by cardiogenic shock.
This study examines outcomes among patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock. Two interventions are compared: intravascular microaxial left ventricular assist devices (LVADs) versus intra-aortic balloon pumps (IABPs). The American College of Cardiology’s National Cardiovascular Data Registry was used to identify patients with AMI complicated by cardiogenic shock from hospitals participating in the CathPCI and Chest Pain-MI registries and identified 28,304 patients. Over the study period (2015 to 2017), LVAD was used in 6.2% of patients and IABP in 29.9%. LVAD was shown to have higher rates of in-hospital death and major bleeding complications compared to IABP.
AHRQ-funded; HS022882; HS025402; HS025517; HS026379.
Citation: Dhruva SS, Ross JS, Mortazavi BJ .
Association of use of an intravascular microaxial left ventricular assist device vs intra-aortic balloon pump with in-hospital mortality and major bleeding among patients with acute myocardial infarction complicated by cardiogenic shock.
JAMA 2020 Feb 25;323(8):734-45. doi: 10.1001/jama.2020.0254..
Keywords: Medical Devices, Heart Disease and Health, Cardiovascular Conditions, Mortality, Adverse Events, Registries, Patient Safety, Patient-Centered Outcomes Research, Evidence-Based Practice
Chandanabhumma PP, Fetters MD, Pagani FD
Understanding and addressing variation in health care-associated infections after durable ventricular assist device therapy: protocol for a mixed methods study.
This paper discusses an ongoing AHRQ-funded study to understand and address variation in health care-associated infections (HAIs) after durable ventricular assist device (VAD) implantation surgery. This procedure is used only on patients with advanced heart failure who have a poor 1-year estimated survival rate. This is a sequential mixed methods study which is conducting a systematic review of HAI prevention studies, and an in-depth quantitative analyses using administration claims, in-depth clinical data, and organizational surveys of VAD centers. The last aim is to develop and disseminate a best practices toolkit for HAI prevention. Data analysis is currently underway.
AHRQ-funded; HS026003.
Citation: Chandanabhumma PP, Fetters MD, Pagani FD .
Understanding and addressing variation in health care-associated infections after durable ventricular assist device therapy: protocol for a mixed methods study.
JMIR Res Protoc 2020 Jan 7;9(1):e14701. doi: 10.2196/14701..
Keywords: Healthcare-Associated Infections (HAIs), Surgery, Medical Devices, Prevention, Heart Disease and Health, Cardiovascular Conditions, Adverse Events
Song J, Tark A, Larson EL
The relationship between pocket hematoma and risk of wound infection among patients with a cardiovascular implantable electronic device: an integrative review.
Pocket hematoma is a common adverse event following the insertion of cardiovascular implantable electronic devices (CIEDs), but the risk of wound infections associated with a pocket hematoma is unclear. The objective of this integrative review was to examine the relationship between pocket hematoma and risk of wound infection in a CIED population.
AHRQ-funded; HS024915.
Citation: Song J, Tark A, Larson EL .
The relationship between pocket hematoma and risk of wound infection among patients with a cardiovascular implantable electronic device: an integrative review.
Heart Lung 2020 Jan-Feb;49(1):92-98. doi: 10.1016/j.hrtlng.2019.09.009..
Keywords: Medical Devices, Cardiovascular Conditions, Surgery, Adverse Events, Healthcare-Associated Infections (HAIs), Injuries and Wounds, Risk
Sobotka SA, Lynch E, Quinn MT
Unmet respite needs of children with medical technology dependence.
Children with medical technology dependency (MTD) require a medical device to compensate for a vital body function and substantial nursing care. As such, they require constant high-level supervision. Respite care provides caregivers with a temporary break, and is associated with reduced stress; however, there are often barriers. The study utilizes mixed methodology with the National Survey of Children with Special Health Care Needs (NS-CSHCN) and semistructured interviews with state-wide care coordinators to understand the gap for respite care services.
AHRQ-funded; HS023007.
Citation: Sobotka SA, Lynch E, Quinn MT .
Unmet respite needs of children with medical technology dependence.
Clin Pediatr 2019 Oct;58(11-12):1175-86. doi: 10.1177/0009922819870251..
Keywords: Children/Adolescents, Medical Devices, Disabilities, Caregiving, Home Healthcare, Care Coordination
Zhang AD, Schwartz JL, Ross JS
Association between Food and Drug Administration Advisory Committee recommendations and agency actions, 2008-2015.
In this paper, the authors examined the association between Food and Drug Administration Advisory Committee Recommendations and agency actions for a time period of 2008-2015. The investigators concluded that the FDA disagrees with the recommendations of its advisory committees a minority of the time, and in these cases it tends to be less likely to approve new products or supplemental indications and take safety actions.
AHRQ-funded; HS022882.
Citation: Zhang AD, Schwartz JL, Ross JS .
Association between Food and Drug Administration Advisory Committee recommendations and agency actions, 2008-2015.
Milbank Q 2019 Sep;97(3):796-819. doi: 10.1111/1468-0009.12403..
Keywords: Medical Devices, Policy, Patient Safety
Wang E, Kang H, Gong Y
Generating a health information technology event database from FDA MAUDE reports.
This study examined using a health information technology (HIT) event database to identify patient safety events (PSEs) or medical errors. The study used the FDA Manufacturer and User Facility Device Experience (MAUDE) database to extract HIT events. Classic and CNN models were utilized on a test set. The model was capable of identifying HIT event with about a 90% accuracy.
AHRQ-funded; HS022895.
Citation: Wang E, Kang H, Gong Y .
Generating a health information technology event database from FDA MAUDE reports.
Stud Health Technol Inform 2019 Aug 21;264:883-87. doi: 10.3233/shti190350..
Keywords: Health Information Technology (HIT), Medical Devices, Adverse Events, Data, Medical Errors, Patient Safety
Reeder HT, Shen C, Buxton AE
Joint shock/death risk prediction model for patients considering implantable cardioverter-defibrillators.
This study’s goal was to develop a joint shock/death risk prediction tool for patients who received implantable cardioverter-defibrillators (ICDs). Secondary analysis of patients was conducted as part of the SCD-HeFT trial (Sudden Cardiac Death in Heart Failure Trial). An illness-death regression model was applied for both ICD shocks and deaths. Among 803 ICD recipients, 430 (53.5%) did not receive an ICD shock or die, 206 (25.7%) received at least 1 shock but did not die, 113 (14.1%) died before receiving a shock, and 54 (6.7%) received at least 1 shock but still died. This predictive performance can be used as a tool for individualized counseling for patients contemplating an ICD.
AHRQ-funded; HS024520.
Citation: Reeder HT, Shen C, Buxton AE .
Joint shock/death risk prediction model for patients considering implantable cardioverter-defibrillators.
Circ Cardiovasc Qual Outcomes 2019 Aug;12(8):e005675. doi: 10.1161/circoutcomes.119.005675..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Medical Devices, Risk, Shared Decision Making, Mortality
Hajduk AM, Gurwitz JH, Tabada G
Influence of multimorbidity on burden and appropriateness of implantable cardioverter-defibrillator therapies.
Researchers sought to determine whether burden of multiple chronic conditions (MCCs) influences the risk of receiving inappropriate vs appropriate device therapies. They studied adults with left ventricular systolic dysfunction receiving an implantable cardioverter-defibrillator (ICD) for primary prevention. In these patients, they found that MCC burden was independently associated with an increased risk of inappropriate but not appropriate device therapies. They recommended considering comorbidity burden when engaging patients in shared decision making about ICD implantation.
AHRQ-funded; 290050033.
Citation: Hajduk AM, Gurwitz JH, Tabada G .
Influence of multimorbidity on burden and appropriateness of implantable cardioverter-defibrillator therapies.
J Am Geriatr Soc 2019 Jul;67(7):1370-78. doi: 10.1111/jgs.15839..
Keywords: Cardiovascular Conditions, Heart Disease and Health, Chronic Conditions, Medical Devices, Prevention, Elderly, Risk, Patient-Centered Outcomes Research