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Topics
- Adverse Events (5)
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- Children/Adolescents (1)
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- Comparative Effectiveness (7)
- Data (2)
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- Dementia (1)
- Elderly (1)
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- Heart Disease and Health (12)
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- (-) Medical Devices (24)
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- Patient Safety (3)
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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 24 of 24 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
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
Steinberg BA, Al-Khatib SM, Edwards R
Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.
The researchers aimed to determine if the benefit of implantable cardioverter-defibrillators (ICDs) is modulated by medical comorbidity. They concluded that patients with extensive comorbid medical illnesses may experience less benefit from primary prevention ICDs than those with less comorbidity, and that implantation should be carefully considered in sick patients. They recommended further study of ICDs in medically complex patients.
AHRQ-funded; HS018505.
Citation: Steinberg BA, Al-Khatib SM, Edwards R .
Outcomes of implantable cardioverter-defibrillator use in patients with comorbidities: results from a combined analysis of 4 randomized clinical trials.
JACC Heart Fail 2014 Dec;2(6):623-9. doi: 10.1016/j.jchf.2014.06.007.
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Keywords: Adverse Events, Heart Disease and Health, Medical Devices, Patient-Centered Outcomes Research
Bilchick KC, Stukenborg GJ
Comparative effectiveness of cardiac resynchronization therapy in combination with implantable defibrillator in patients with heart failure and wide QRS duration.
The researchers examined the long-term outcomes among Medicare patients with cardiac resynchronization therapy defibrillators (CRT-D) compared with those receiving standard implantable cardioverter defibrillators. They found that the greatest benefit of CRT-D was in patients with guideline-based class I recommendations for CRT-D. For these patients, there was a 17 percent reduction in risk of death.
AHRQ-funded; HS017693
Citation: Bilchick KC, Stukenborg GJ .
Comparative effectiveness of cardiac resynchronization therapy in combination with implantable defibrillator in patients with heart failure and wide QRS duration.
Am J Cardiol. 2014 Nov 15;114(10):1537-42. doi: 10.1016/j.amjcard.2014.08.017..
Keywords: Comparative Effectiveness, Medicare, Outcomes, Cardiovascular Conditions, Medical Devices
Berliner E
AHRQ Author: Berliner E
Adopting medical technology.
This editorial described a study by Gold and colleagues within this issue concerning the treatment accelerated partial breast irradiation (APBI), which was incorporated into clinical practice with few data on its benefits and risks. Berliner recommends a coordinated approach to evidence generation.
AHRQ-authored.
Citation: Berliner E .
Adopting medical technology.
Med Decis Making 2014 Nov;34(8):948-50. doi: 10.1177/0272989x14546378.
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Keywords: Evidence-Based Practice, Medical Devices
Khazanie P, Hammill BG, Qualls LG
Clinical effectiveness of cardiac resynchronization therapy versus medical therapy alone among patients with heart failure: analysis of the ICD Registry and ADHERE.
The researchers examined associations between cardiac resynchronization therapy with defibrillator (CRT-D) and mortality and readmission among patients with heart failure who received CRT-D in clinical practice, compared with those who received medical therapy alone. They found that CRT-D was associated with lower risks of mortality and readmission than medical therapy alone.
AHRQ-funded; HS021092
Citation: Khazanie P, Hammill BG, Qualls LG .
Clinical effectiveness of cardiac resynchronization therapy versus medical therapy alone among patients with heart failure: analysis of the ICD Registry and ADHERE.
Circ Heart Fail. 2014 Nov;7(6):926-34. doi: 10.1161/circheartfailure.113.000838..
Keywords: Comparative Effectiveness, Heart Disease and Health, Medical Devices, Hospital Readmissions, Outcomes
Yeh JS, Austad KE, Franklin JM
Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.
The study’s goal was to determine which medical school characteristics and which conflict of interest policy dimensions were most predictive of students’ reported behaviors. It found that students at schools with the highest ranked interaction policies based on the American Medical Student Association (AMSA) score were 63 percent less likely to accept gifts as students at the lowest ranked schools.
AHRQ-funded; HS018465.
Citation: Yeh JS, Austad KE, Franklin JM .
Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.
PLoS Med 2014 Oct;11(10):e1001743. doi: 10.1371/journal.pmed.1001743..
Keywords: Medical Devices, Medication, Policy, Practice Patterns
Borne RT, Peterson PN, Greenlee R
Temporal trends in patient characteristics and outcomes among Medicare beneficiaries undergoing primary prevention implantable cardioverter-defibrillator placement in the United States, 2006-2010.
Results from the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry. This study characterizing trends in clinical profiles and outcomes among Medicare patients undergoing primary implantable cardioverter-defibrillator implantation found only modest changes in clinical characteristics between 2006 and 2010. However, 6-month mortality and rehospitalization improved significantly over time, suggesting that there were meaningful improvements.
AHRQ-funded; HS019814
Citation: Borne RT, Peterson PN, Greenlee R .
Temporal trends in patient characteristics and outcomes among Medicare beneficiaries undergoing primary prevention implantable cardioverter-defibrillator placement in the United States, 2006-2010.
Circulation. 2014 Sep 2;130(10):845-53. doi: 10.1161/CIRCULATIONAHA.114.008653..
Keywords: Medical Devices, Outcomes, Medicare, Registries, Quality of Care
Setoguchi SR, Warner Stevenson L, Stewart GC
Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure.
This study assessed the potential contribution of unmeasured general health status to patient selection in assessments of implantable cardioverter-defibrillator (ICD) therapy. In a group of heart failure patients, those who received ICD therapy were younger and had lower ejection fraction and more cardiac admissions to hospital but fewer non-cardiac admissions. The lower risks of measured outcomes likely reflect unmeasured differences in comorbidity and frailty.
AHRQ-funded; 29020050016I; HS017731
Citation: Setoguchi SR, Warner Stevenson L, Stewart GC .
Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure.
BMJ. 2014 May 8;348:g2866. doi: 10.1136/bmj.g2866..
Keywords: Medical Devices, Outcomes, Registries, Heart Disease and Health, Medicare
Hwang TJ, Kesselheim AS, Bourgeois FT
Postmarketing trials and pediatric device approvals.
The authors sought to describe the current state of trial evidence underpinning the approval of pediatric devices. They found that most high-risk pediatric devices are approved on the basis of trials in patients 18 years of age or older, with few pediatric patients exposed to the devices before market availability. Also, few postmarketing studies require additional study in pediatric patients.
AHRQ-funded; HS018465.
Citation: Hwang TJ, Kesselheim AS, Bourgeois FT .
Postmarketing trials and pediatric device approvals.
Pediatrics 2014 May;133(5):e1197-202. doi: 10.1542/peds.2013-3348.
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Keywords: Children/Adolescents, Medical Devices, Patient Safety, Children/Adolescents
Setoguchi S, Zhu Y, Jalbert JJ
Validity of deterministic record linkage using multiple indirect personal identifiers: linking a large registry to claims data.
The researchers compared the validity of several deterministic record linkage methods with multiple indirect identifiers by using data from the Centers for Medicare and Medicaid Services (CMS) implantable cardioverter-defibrillator (ICD) registry and administrative Medicare inpatient claims data. Linkage rules using 2 or 3 indirect, patient-level identifiers and hospital ID produced linkages with sensitivity of 95% and specificity of 98% compared with a gold standard linkage rule.
AHRQ-funded; 29020050016I; HS017731.
Citation: Setoguchi S, Zhu Y, Jalbert JJ .
Validity of deterministic record linkage using multiple indirect personal identifiers: linking a large registry to claims data.
Circ Cardiovasc Qual Outcomes 2014 May;7(3):475-80. doi: 10.1161/circoutcomes.113.000294..
Keywords: Medical Devices, Medicare, Registries, Data, Inpatient Care
Al-Khatib SM, Han JY, Edwards R
Do patients with a left ventricular ejection fraction between 30% and 35% benefit from a primary prevention implantable cardioverter defibrillator?
The researchers used data from randomized clinical trials involving patients with systolic heart failure who had received implantable cardioverter-defibrillators and compared outcomes for those whose left ventricular ejection fractions (LVEFs) was between 30 percent and 35 percent with those whose LVEF was less than 30 percent. The sample size was too small to permit any important conclusions.
AHRQ-funded; HS018505
Citation: Al-Khatib SM, Han JY, Edwards R .
Do patients with a left ventricular ejection fraction between 30% and 35% benefit from a primary prevention implantable cardioverter defibrillator?
Int J Cardiol. 2014 Mar 1;172(1):253-4. doi: 10.1016/j.ijcard.2013.12.278..
Keywords: Comparative Effectiveness, Outcomes, Medical Devices, Heart Disease and Health, Chronic Conditions
Kesselheim AS, Xu S
Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
In order to better understand medical device innovation, the researchers conducted interviews with the innovators whose work contributed to the development of coronary artery stents. They found that individual physician-inventors saw the need for coronary artery stents in their clinical practice and then developed prototypes with the support of academic medical centers, followed by early validation studies.
AHRQ-funded; HS018465
Citation: Kesselheim AS, Xu S .
Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
PLoS One. 2014 Feb 12;9(2):e88664. doi: 10.1371/journal.pone.0088664..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Medical Devices
Earley A, Persson R, Garlitski AC
Effectiveness of implantable cardioverter defibrillators for primary prevention of sudden cardiac death in subgroups a systematic review.
The purpose of this review was to examine ICD effectiveness for primary prevention of SCD across subgroups by sex, age, QRS interval, time since myocardial infarction, blood urea nitrogen level, and diabetes. It concluded that there was weak evidence showing differences for all-cause mortality in subgroups of sex, age, and QRS interval. Also, evidence was indeterminate for all-cause mortality in the other subgroups and for SCD.
AHRQ-funded; 290200710055I.
Citation: Earley A, Persson R, Garlitski AC .
Effectiveness of implantable cardioverter defibrillators for primary prevention of sudden cardiac death in subgroups a systematic review.
Ann Intern Med 2014 Jan 21;160(2):111-21. doi: 10.7326/m13-1787..
Keywords: Medical Devices, Comparative Effectiveness, Prevention, Mortality
Rome BN, Kramer DB, Kesselheim AS
Approval of high-risk medical devices in the US: implications for clinical cardiology.
The authors review the premarket approval (PMA) process to approve high-risk cardiovascular devices, as well as the five different types of PMA supplements used to approve alterations to device design. They summarize the types of data required to approve new high-risk cardiovascular devices and discuss implications of the PMA process for clinicians and patients.
AHRQ-funded; HS018465
Citation: Rome BN, Kramer DB, Kesselheim AS .
Approval of high-risk medical devices in the US: implications for clinical cardiology.
Curr Cardiol Rep. 2014;16(6):489. doi: 10.1007/s11886-014-0489-0..
Keywords: Medical Devices, Cardiovascular Conditions, Patient Safety