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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 25 of 71 Research Studies DisplayedMovahedi F, Kanwar MK, Antaki JF
Timelines of adverse event journeys of LVAD patients.
The objective of this study was to investigate the timelines of adverse events (AEs) in the INTERMACS database to obtain insights into the "AE journeys" of left ventricular assist device (LVAD) patients. The characteristics of the timelines were investigated via six descriptive research questions. The analysis revealed time-related characteristics and patterns of the AE journey after LVAD, including the most common time of occurrences, duration, and time intervals between AEs. The authors concluded that the INTERMACS Event dataset is a valuable resource for research about the timeline of AE journeys of LVAD patients and noted that future studies should consider the time-related characteristics of the dataset to choose an appropriate scope of time and time granularity.
AHRQ-funded; HS027784.
Citation: Movahedi F, Kanwar MK, Antaki JF .
Timelines of adverse event journeys of LVAD patients.
Artif Organs 2023 Oct; 47(10):1604-12. doi: 10.1111/aor.14596..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Adverse Events, Medical Devices
Zhou S, Yang G, Hou H
Infections following left ventricular assist device implantation and 1-year health-related quality of life.
This study examined number and types of infection following left ventricular assist device (LVAD) implantation and its adverse effects on patient-reported health-related quality of life (HRQOL). Participants were patients from the Society of Thoracic Surgeons' Interagency Registry for Mechanically Assisted Circulatory Support who had received a primary LVAD. The results showed that each additional infection within the first post-implantation year was associated with an incremental negative effect on patient survival free of impaired HRQOL.
AHRQ-funded; HS026003.
Citation: Zhou S, Yang G, Hou H .
Infections following left ventricular assist device implantation and 1-year health-related quality of life.
J Heart Lung Transplant 2023 Sep; 42(9):1307-15. doi: 10.1016/j.healun.2023.05.006..
Keywords: Heart Disease and Health, Medical Devices, Cardiovascular Conditions, Quality of Care
Hamer MK, DeCamp M, Bradley CJ
Adoption and value of the Medicare annual wellness visit: a mixed-methods study.
Medicare's Annual Wellness Visit (AWV) was introduced in 2011 to encourage the utilization of preventive services, but many clinicians and patients still do not participate in the visit. We qualitatively and quantitatively assessed motivations and clinical and financial value of AWVs from a primary care perspective using interviews and Medicare claims from 2012 to 2019. Primary care providers with the highest acuity patients had AWV utilization rates 11.2 percentage points lower than providers with the lowest acuity patients; utilization rates were 3.8 percentage points lower in rural counties. Adoption was motivated by patient needs and financial incentives. AWVs closed gaps in preventive care, strengthened patient-provider relationships, facilitated advance care planning, and provided an opportunity to improve quality metrics. Overall, the AWV has the potential to increase the use of high-value preventive services although not all clinics have an economic incentive to adopt the visit, which may explain some of the variability in utilization rates.
AHRQ-funded; HS026613.
Citation: Hamer MK, DeCamp M, Bradley CJ .
Adoption and value of the Medicare annual wellness visit: a mixed-methods study.
Med Care Res Rev 2023 Aug; 80(4):433-43. doi: 10.1177/10775587231166037..
Keywords: Medical Devices, Prevention
Zhou S, Yang G, Zhang M
Mortality following durable left ventricular assist device implantation by timing and type of first infection.
Researchers examined the relationship between timing and type of first infection regarding mortality following left ventricular assist device implantation. The study cohort included nearly 13,000 Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support patients at 166 centers. The results showed that patients with any post-implantation infection had an increased risk of death; ventricular assist device-related infections and infections occurring in the intermediate interval (91-180 days after implantation) were associated with the largest increase in risk. The researchers recommended that infection prevention strategies should target non-ventricular assist device infections in the first 90 days, then shift to surveillance/prevention of driveline infections after 90 days.
AHRQ-funded; HS026003.
Citation: Zhou S, Yang G, Zhang M .
Mortality following durable left ventricular assist device implantation by timing and type of first infection.
J Thorac Cardiovasc Surg 2023 Aug; 166(2):570-79.e4. doi: 10.1016/j.jtcvs.2021.10.056..
Keywords: Mortality, Cardiovascular Conditions, Medical Devices, Heart Disease and Health
Montembeau SC, Merchant FM, Speight C
Patients' perspectives regarding generator exchanges of implantable cardioverter defibrillators.
This study explored how patients make implantable cardioverter defibrillator (ICD) generator exchange decisions. Fifty patients from Emory Healthcare with primary prevention ICDs implanted from 2013 to 2021 completed in-depth interviews exploring perspectives regarding generator exchanges. Patients were presented standard-gamble type hypothetical scenarios where their ICD battery was depleted but their 5-year risk of sudden cardiac death at that time varied (10%, 5%, and 1%). Among these patients, 18 had a prior generator exchange, 16 had received ICD therapy, and 17 had improved left ventricular ejection fraction. As sudden cardiac death risk decreased from 10% to 5% to 1%, the number of participants willing to undergo a generator exchange decreased from 48 to 42 to 33. Doctor recommendations were also likely to substantially impact patients’ decision making. Therapeutic inertia and common misconceptions about ICD therapy represented substantive barriers to effective shared decision-making.
AHRQ-funded; HS028558.
Citation: Montembeau SC, Merchant FM, Speight C .
Patients' perspectives regarding generator exchanges of implantable cardioverter defibrillators.
Circ Cardiovasc Qual Outcomes 2023 Aug; 16(8):509-18. doi: 10.1161/circoutcomes.122.009827..
Keywords: Medical Devices, Heart Disease and Health, Cardiovascular Conditions
MacEwan SR, Gaughan AA, Beal EW
Concerns and frustrations about the public reporting of device-related healthcare-associated infections: perspectives of hospital leaders and staff.
The purpose of this study was to explore the specific concerns of hospital leaders and staff regarding the identification and public reporting of healthcare-associated infections (HAIs). Between 2017 and 2019 the researchers conducted interviews with 471 participants including hospitals leaders and hospital staff across 18 United States hospitals. The study found that interviewees discussed concerns about public reporting of HAI data, including a lack of trust in the data and unintended consequences of its public reporting, as well as particular frustrations with the identification and accountability for publicly-reported HAIs.
AHRQ-funded; HS024958.
Citation: MacEwan SR, Gaughan AA, Beal EW .
Concerns and frustrations about the public reporting of device-related healthcare-associated infections: perspectives of hospital leaders and staff.
Am J Infect Control 2023 Jun; 51(6):633-37. doi: 10.1016/j.ajic.2022.08.003..
Keywords: Medical Devices, Healthcare-Associated Infections (HAIs), Hospitals, Provider: Health Personnel
Everhart AO
Time to publication of cost-effectiveness analyses for medical devices.
This study examined the availability of cost-effectiveness analyses for medical devices, in terms of both the number of studies and when studies are published. The longer the time between FDA approval/clearance and publication of cost-effectiveness analyses of medical devices, the longer that decision makers will not have the evidence they and their patients need when making initial decisions related to newly available medical devices. An analysis was conducted using the Tufts University Cost-Effectiveness Analysis Registry to identify studies of medical devices that were linked to FDA databases. The years between FDA approval/clearance and publication of cost-effectiveness analyses were calculated. The authors identified a total of 218 cost-effectiveness analyses of medical devices in the United States published between 2002 and 2020. Of those studies, 39.4% were linked to FDA databases. Studies examining devices approved via premarket approval were published a mean of 6.0 years after the device received FDA approval, whereas studies examining devices that were cleared via the 510(k) process were published a mean of 6.5 years after the device received FDA clearance.
AHRQ-funded; HS027522.
Citation: Everhart AO .
Time to publication of cost-effectiveness analyses for medical devices.
Am J Manag Care 2023 May; 29(5):265-68. doi: 10.37765/ajmc.2023.89359..
Keywords: Medical Devices, Healthcare Costs
Weiner M, Adeoye P, Boeh MJ
Continuous glucose monitoring and other wearable devices to assess hypoglycemia among older adult outpatients with diabetes mellitus.
The purpose of this study was to assess whether vulnerable older adults could use wearable devices, and explore Hypoglycemia frequency over a two week period. The researchers recruited 10 participants with diabetes mellitus to pilot test a continuous glucometer, physical activity monitor, electronic medication bottles, and smartphones which that provided prompts about medications, behaviors, and symptoms. A sample of 70 then wore glucometers and activity monitors and used the smartphone and bottles for a duration of 2 weeks and provided feedback. The study found that patients were interested in assistance with the interpretation of graphs, had challenges with keeping the glucometers attached. Nearly 23% of respondents indicated that they never check their blood sugars. In two weeks of monitoring, 73% had HG and 42% had serious, clinically significant HG.
AHRQ-funded; HS024384.
Citation: Weiner M, Adeoye P, Boeh MJ .
Continuous glucose monitoring and other wearable devices to assess hypoglycemia among older adult outpatients with diabetes mellitus.
Appl Clin Inform 2023 Jan; 14(1):37-44. doi: 10.1055/a-1975-4136..
Keywords: Elderly, Diabetes, Chronic Conditions, Ambulatory Care and Surgery, Patient Self-Management, Medical Devices
Funk RJ, Pagani FD, Hou H
Care fragmentation predicts 90-day durable ventricular assist device outcomes.
The purpose of this cohort study was to investigate the relationship between care fragmentation and in-hospital as well as 90-day post-operative outcomes for patients receiving durable ventricular assist device (VAD) implants. The research utilized Medicare claims connected to the Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) for patients who underwent VAD implantation from July 2009 to April 2017. Medicare information was employed to assess the fragmentation of the multidisciplinary care delivery network at the treating hospital, based on the providers' patient-sharing history within the preceding year. The STS Intermacs database was utilized for risk adjustment and outcome determination. Hospitals were categorized into terciles according to the level of network fragmentation, measured by the average number of connections separating providers in the network. Multivariable regression analysis was conducted to examine the association between network fragmentation and the risk of death or infection within 90 days. The study included 5159 patients who received VAD implants, and found 11.2% mortality and 27.6% infection incidence within 90 days following implantation. After adjusting for confounders, a one-unit increase in network fragmentation correlated with a 0.179 rise in in-hospital infection probability and a 0.183 increase in the likelihood of 90-day infection. Comparable findings were observed in models assessing the number of in-hospital and 90-day infections. While network fragmentation was a predictor of 90-day mortality probability, this association was not significant after adjustment.
AHRQ-funded; HS026003
Citation: Funk RJ, Pagani FD, Hou H .
Care fragmentation predicts 90-day durable ventricular assist device outcomes.
Am J Manag Care 2022 Dec;28(12):e444-e51. doi: 10.37765/ajmc.2022.89280.
Keywords: Medical Devices, Heart Disease and Health, Cardiovascular Conditions
A Wehbe, RM Wu, T
AHRQ Author: Tibrewala
Hyponatremia is a powerful predictor of poor prognosis in left ventricular assist device patients.
Researchers sought to investigate the prognostic value of serum sodium in left ventricular assist device (LVAD) patients and whether hyponatremia reflects worsening heart failure or an alternative mechanism. Heart failure patients who had undergone LVAD implantation 2008-2019 were identified; the researchers assessed for differences in hyponatremia before and after implantation. The findings suggested that hyponatremia in LVAD patients was associated with a significantly higher risk of all-cause mortality and recurrent heart failure hospitalizations. The researchers concluded that hyponatremia may be a marker of ongoing neurohormonal activation more sensitive than other lab values, echocardiography parameters, and hemodynamic measurements.
AHRQ-funded; HS026385.
Citation: A Wehbe, RM Wu, T .
Hyponatremia is a powerful predictor of poor prognosis in left ventricular assist device patients.
ASAIO J 2022 Dec;68(12):1475-82. doi: 10.1097/mat.0000000000001691.
Keywords: Medical Devices, Heart Disease and Health, Cardiovascular Conditions
Marcaccio CL, O'Donnell TFX, Dansey KD
Disparities in reporting and representation by sex, race, and ethnicity in endovascular aortic device trials.
The purpose of this study was to examine the demographics of patients enrolled in critical U.S. endovascular aortic device trials to explore the representation of vulnerable populations, including women and racial and ethnic minorities. The primary outcomes included the percentage of trials reporting participant sex, race, and ethnicity and the percentage of participants across sex, racial, and ethnic groups. The study found that the Food and Drug Administration (FDA) provided 29 approvals from 29 trials of 24 devices with a total of 4046 patients: 52% (15) were EVAR devices, 41% (12) were TEVAR devices, and 3.4% (1) was a FEVAR device, with 1 dissection stent (3.4%). Fifty-two percent of the trials reported the three most common racial groups (White, Black, Asian), and 48% reported Hispanic ethnicity. The TEVAR trials were the most likely to report all three racial groups and Hispanic ethnicity (92% and 75%, respectively), while the EVAR trials had the lowest reporting rates (13% and 20%, respectively). The median female enrollment was 21%, with the EVAR trials having the lowest female enrollment compared with 41% in the TEVAR trials, 21% in the FEVAR trial, and 34% in the dissection stent trial. The study concluded that in critical aortic device trials that led to FDA approval, female patients were underrepresented, especially for EVAR, and racial and ethnic minority groups were under-represented and underreported.
AHRQ-funded; HS027285.
Citation: Marcaccio CL, O'Donnell TFX, Dansey KD .
Disparities in reporting and representation by sex, race, and ethnicity in endovascular aortic device trials.
J Vasc Surg 2022 Nov;76(5):1244-52.e2. doi: 10.1016/j.jvs.2022.05.003..
Keywords: Disparities, Racial and Ethnic Minorities, Heart Disease and Health, Cardiovascular Conditions, Medical Devices, Sex Factors
Likosky DS, Yang G, Zhang M
Interhospital variability in health care-associated infections and payments after durable ventricular assist device implant among Medicare beneficiaries.
The purpose of this study was to examine differences in durable ventricular assist device implantation infection rates and associated costs across hospitals. The researchers utilized clinical data for 8,688 patients who received primary durable ventricular assist devices from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) hospitals (n = 120) and merged that data with post-implantation 90-day Medicare claims. The primary outcome included infections within 90 days of implantation and Medicare payments. The study found that 27.8% of patients developed 3982 identified infections. The median adjusted incidence of infections (per 100 patient-months) across hospitals was 14.3 and differed according to hospital. Total Medicare payments from implantation to 90 days were 9.0% more in high versus low infection tercile hospitals. The researchers concluded that health-care-associated infection rates post durable ventricular assist device implantation varied according to hospital and were associated with increased 90-day Medicare expenditures.
AHRQ-funded; HS026003.
Citation: Likosky DS, Yang G, Zhang M .
Interhospital variability in health care-associated infections and payments after durable ventricular assist device implant among Medicare beneficiaries.
J Thorac Cardiovasc Surg 2022 Nov;164(5):1561-68. doi: 10.1016/j.jtcvs.2021.04.074..
Keywords: Healthcare-Associated Infections (HAIs), Medical Devices, Medicare, Heart Disease and Health, Cardiovascular Conditions, Hospitals, Payment, Healthcare Costs
Yang G, Zhang M, Zhou S
Incompleteness of health-related quality of life assessments before left ventricular assist device implant: a novel quality metric.
Investigators hypothesized that pre-implant health-related quality of life (HRQOL) incompleteness in The Society of Thoracic Surgeons' Intermacs registry for patients undergoing left ventricular assist device (LVAD) implantation predicts 90-day outcomes. They found that HRQOL incompleteness at high-rate hospitals was more often due to administrative reasons and less likely due to patient reasons. Increases in the adjusted pre-implant incompleteness rates were significantly associated with higher risk of infection-related mortality, infection, and renal dysfunction. They concluded that hospital adjusted pre-implant HRQOL incompleteness was predictive of 90-day post-implant outcomes and may serve as a novel quality metric.
AHRQ-funded; HS026003.
Citation: Yang G, Zhang M, Zhou S .
Incompleteness of health-related quality of life assessments before left ventricular assist device implant: a novel quality metric.
J Heart Lung Transplant 2022 Oct;41(10):1520-28. doi: 10.1016/j.healun.2022.07.001..
Keywords: Quality of Life, Medical Devices, Heart Disease and Health, Cardiovascular Conditions
Kim KD, Funk RJ, Hou H
Association between care fragmentation and total spending after durable left ventricular device implant: a mediation analysis of health care-associated infections within a national Medicare-Society of Thoracic Surgeons INTERMACS linked dataset.
The purpose of this study was to examine the relationship between care fragmentation and total spending for durable left ventricular assisted device (LVAD) implant, and whether this relationship is mediated by infections. The researchers developed a measure of care fragmentation based on the number of shared medical professionals providing care to 4,987 Medicare beneficiaries undergoing LVAD implantation. The study found that the indirect effect of care fragmentation, through infections, was positive and statistically significant. The researchers concluded that higher care fragmentation associated with durable LVAD implantation is related with a greater incidence of infections and higher Medicare beneficiary payments.
AHRQ-funded; HS026003.
Citation: Kim KD, Funk RJ, Hou H .
Association between care fragmentation and total spending after durable left ventricular device implant: a mediation analysis of health care-associated infections within a national Medicare-Society of Thoracic Surgeons INTERMACS linked dataset.
Circ Cardiovasc Qual Outcomes 2022 Sep;15(9):e008592. doi: 10.1161/circoutcomes.121.008592..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Healthcare Costs, Healthcare-Associated Infections (HAIs), Medicare, Medical Devices, Healthcare Delivery
Mao J, Sedrakyan A, Sun T
Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.
This study’s objective was to develop an annotation model to develop natural language processing (NLP) to device adverse event reports and to implement the model to evaluate the most frequently experienced events among women reporting a sterilization device removal. Adverse event reports from the Manufacturer and User Facility Device Experience database from January 2005 to June 2018 were included. The authors used an iterative process to develop an annotation model that extracts six categories of desired information and applied the annotation model to train an NLP algorithm. A total of 16,535 reports of device removal were analyzed with the most frequently reported patient and device events being abdominal/pelvic/genital pain (79.6%) and device dislocation/migration (19.2%), respectively. A total of 7,932 patients reported an additional sterilization procedure of a hysterectomy or salpingectomy. One-fifth of the cases that had device removal timing specified reported a removal 7 years after original insertion.
AHRQ-funded; HS026291.
Citation: Mao J, Sedrakyan A, Sun T .
Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.
Pharmacoepidemiol Drug Saf 2022 Apr;31(4):442-51. doi: 10.1002/pds.5402..
Keywords: Adverse Events, Surgery, Medical Devices, Patient Safety
Grennan M, Kim GH, McConnell KJ
Hospital management practices and medical device costs.
The authors sought to determine whether the variation in prices paid for cardiac medical devices was associated with management practices in cardiac units. Unit prices on management practice scores and other hospital characteristics were regressed for the 11 top-spending cardiac device categories. The authors found that better management practices were associated with lower device prices. They noted that this modest magnitude was similar to other events expected to lower input prices, such as transparency in the form of benchmarking information and hospital mergers.
AHRQ-funded; HS018466.
Citation: Grennan M, Kim GH, McConnell KJ .
Hospital management practices and medical device costs.
Health Serv Res 2022 Apr;57(2):227-36. doi: 10.1111/1475-6773.13898..
Keywords: Medical Devices, Hospitals, Healthcare Costs
Pienta MJ, Shore S, Watt TMF
Patient factors associated with left ventricular assist device infections: a scoping review.
This article is a scoping review that systematically summarized all existing studies examining patient-related factors associated with infections after left ventricular assist device (LVAD) implantation. Studies published between January 2006 and February 2019 were used, with 31 studies meeting inclusion criteria. All included studies were observational, and 17 focused on driveline infections. Other factors most commonly studied included body composition (n = 8), diabetes and other comorbidities (n = 8), and psychosocial/socio-economic factors (n = 6). Studies were frequently single-center, and patient race and sex did not correlate with infection risk. There was also no consistent association noted between obesity, diabetes, or psychosocial/socio-economic factors and LVAD recipient infections. Two studies did report a significant association between malnutrition and hypoalbuminemia and post implant infections.
AHRQ-funded; HS026003.
Citation: Pienta MJ, Shore S, Watt TMF .
Patient factors associated with left ventricular assist device infections: a scoping review.
J Heart Lung Transplant 2022 Apr; 41(4):425-33. doi: 10.1016/j.healun.2022.01.011..
Keywords: Medical Devices, Healthcare-Associated Infections (HAIs), Heart Disease and Health, Cardiovascular Conditions
Valbuena VSM, Barbaro RP, Claar D
Racial bias in pulse oximetry measurement among patients about to undergo extracorporeal membrane oxygenation in 2019-2020: a retrospective cohort study.
This study examined whether pulse oximeters detect arterial hypoxemia less effectively in Black, Hispanic, and/or Asian patients than in White patients in respiratory failure who are about to undergo extracorporeal membrane oxygenation (ECMO). Data on adult patients with respiratory failure readings 6 hours before ECMO from 324 centers from January 2019 to July 2020 who were in the Extracorporeal Life Support Organization registry was used. The author’s primary analysis was of rates of occult hypoxemia-low arterial oxygen saturation (Sao(2) ≤ 88%) on arterial blood gas measurement despite a pulse oximetry reading in the range of 92% to 96%. The rate of pre-ECMO occult hypoxemia was 10.2% for 186 White patients with peripheral oxygen saturation; 21.5% for 51 Black patients; 8.6% for 70 Hispanic patients; and 9.2% for 75 Asian patients. The risk of occult hypoxemia was comparable for Hispanic and Asian patients to White patients, but the prevalence of occult hypoxemia was higher in Black patients than for White patients about to undergo ECMO for respiratory failure.
AHRQ-funded; HS028038.
Citation: Valbuena VSM, Barbaro RP, Claar D .
Racial bias in pulse oximetry measurement among patients about to undergo extracorporeal membrane oxygenation in 2019-2020: a retrospective cohort study.
Chest 2022 Apr;161(4):971-78. doi: 10.1016/j.chest.2021.09.025..
Keywords: Racial and Ethnic Minorities, Medical Devices, Respiratory Conditions
Rao BR, Merchant FM, Abernethy ER
The impact of government-mandated shared decision-making for implantable defibrillators: a natural experiment.
This study examined the impact of the 2018 Centers for Medicare and Medicaid Services (CMS) mandate that patients considering implantation of an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death undergo shared decision-making (SDM) using a decision-aid. The authors surveyed patients who underwent implantation of a primary prevention ICD within the Emory Healthcare system between 2017-2019 (pre and post SDM mandate). Survey domains included decisional conflict, knowledge about the ICD, values-choice concordance, and engagement in decision-making. Of 101 patients who completed the survey, 45 had an ICD placed before the mandate and 56 placed after. No major differences were found between any of the survey domains. Patients with ICDs after the mandate were more likely to subjectively feel more informed about the benefits of the procedure but were less likely to be able to correctly identify the frequency of complications.
AHRQ-funded; HS028558.
Citation: Rao BR, Merchant FM, Abernethy ER .
The impact of government-mandated shared decision-making for implantable defibrillators: a natural experiment.
Pacing Clin Electrophysiol 2022 Feb; 45(2):274-80. doi: 10.1111/pace.14414..
Keywords: Shared Decision Making, Medical Devices, Policy, Cardiovascular Conditions
Shore S, Pienta MJ, Watt TMF
Non-patient factors associated with infections in LVAD recipients: a scoping review.
Infections are the most common complication in recipients of durable left ventricular assist devices (LVAD) and are associated with increased morbidity, mortality, and expenditures. The existing literature examining factors associated with infection in LVAD recipients is limited and principally comprises single-center studies. This scoping review synthesized all available evidence related to identifying modifiable, non-patient factors associated with infections among LVAD recipients.
AHRQ-funded; HS026003.
Citation: Shore S, Pienta MJ, Watt TMF .
Non-patient factors associated with infections in LVAD recipients: a scoping review.
J Heart Lung Transplant 2022 Jan;41(1):1-16. doi: 10.1016/j.healun.2021.10.006..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Surgery, Medical Devices
Rao BR, Merchant FM, Howard DH
Shared decision-making for implantable cardioverter-defibrillators: policy goals, metrics, and challenges.
Researchers discussed shared decision-making for implantable cardioverter-defibrillators (ICDs), including the results from a case study implementing the shared decision-making mandate for ICDs, which involved providing patients with decision aids prior to or following the doctor consultation.
AHRQ-funded; HS028558.
Citation: Rao BR, Merchant FM, Howard DH .
Shared decision-making for implantable cardioverter-defibrillators: policy goals, metrics, and challenges.
J Law Med Ethics 2021 Win;49(4):622-29. doi: 10.1017/jme.2021.85..
Keywords: Shared Decision Making, Medical Devices, Policy, Cardiovascular Conditions
Brescia AA, Watt TMF, Pagani FD
Assessment of mortality among durable left ventricular assist device recipients ineligible for clinical trials.
This study compared the mortality of heart patients undergoing durable left ventricular assist device (LVAD) implantation who were enrolled in a clinical trial called Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) to general population LVAD recipients from 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Among 14,679 recipients, a total of 6429 recipients (43.8%) would have been ineligible for enrollment in the MOMENTUM 3 study. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (25.3% versus 16.2% for 1-year mortality, 42.8% versus 36.4% for 3-year mortality). The authors concluded that a better representation of the patient population would reflect real-world experience better than the trial eligibility criteria that was used.
AHRQ-funded; HS026003.
Citation: Brescia AA, Watt TMF, Pagani FD .
Assessment of mortality among durable left ventricular assist device recipients ineligible for clinical trials.
JAMA Netw Open 2021 Jan 4;4(1):e2032865. doi: 10.1001/jamanetworkopen.2020.32865..
Keywords: Heart Disease and Health, Cardiovascular Conditions, Mortality, Medical Devices
Mentias 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