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1.
Article in English | MEDLINE | ID: mdl-38692480

ABSTRACT

OBJECTIVE: Women are less likely to receive guideline-recommended cardiovascular care, but evaluation of sex-based disparities in cardiac surgical procedures is limited. Receipt of concomitant atrial fibrillation (AF) procedures during nonmitral cardiac surgery was compared by sex for patients with preoperative AF. METHODS: Patients with preoperative AF undergoing coronary artery bypass grafting and/or aortic valve replacement at any of the 33 hospitals in Michigan from 2014 to 2022 were included. Patients with prior cardiac surgery, transcatheter AF procedure, or emergency/salvage status were excluded. Hierarchical logistic regression identified predictors of concomitant AF procedures, account for hospital and surgeon as random effects. RESULTS: Of 5460 patients with preoperative AF undergoing nonmitral cardiac surgery, 24% (n = 1291) were women with a mean age of 71 years. Women were more likely to have paroxysmal (vs persistent) AF than men (80% vs 72%; P < .001) and had a higher mean predicted risk of mortality (5% vs 3%; P < .001). The unadjusted rate of concomitant AF procedure was 59% for women and 67% for men (P < .001). After risk adjustment, women had 26% lower adjusted odds of concomitant AF procedure than men (adjusted odds ratio, 0.74; 95% CI, 0.64-0.86; P < .001). Female sex was the risk factor associated with the lowest odds of concomitant AF procedure. CONCLUSIONS: Women are less likely to receive guideline recommended concomitant AF procedure during nonmitral surgery. Identification of barriers to concomitant AF procedure in women may improve treatment of AF.

2.
Circ Cardiovasc Qual Outcomes ; : e010459, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38770653

ABSTRACT

BACKGROUND: Home health care (HHC) has been increasingly used to improve care transitions and avoid poor outcomes, but there is limited data on its use and efficacy following coronary artery bypass grafting. The purpose of this study was to describe HHC use and its association with outcomes among Medicare beneficiaries undergoing coronary artery bypass grafting. METHODS: Retrospective analysis of 100% of Medicare fee-for-service files identified 77 331 beneficiaries undergoing coronary artery bypass grafting and discharged to home between July 2016 and December 2018. The primary exposure of HHC use was defined as the presence of paid HHC claims within 30 days of discharge. Hierarchical logistic regression identified predictors of HHC use and the percentage of variation in HHC use attributed to the hospital. Propensity-matched logistic regression compared mortality, readmissions, emergency department visits, and cardiac rehabilitation enrollment at 30 and 90 days after discharge between HHC users and nonusers. RESULTS: A total of 26 751 (34.6%) of beneficiaries used HHC within 30 days of discharge, which was more common among beneficiaries who were older (72.9 versus 72.5 years), male (79.4% versus 77.4%), White (90.2% versus 89.2%), and not Medicare-Medicaid dual eligible (6.7% versus 8.8%). The median hospital-level rate of HHC use was 31.0% (interquartile range, 13.7%-54.5%) and ranged from 0% to 94.2%. Nearly 30% of the interhospital variation in HHC use was attributed to the discharging hospital (intraclass correlation coefficient, 0.296 [95% CI, 0.275-0.318]). Compared with non-HHC users, those using HHC were less likely to have a readmission or emergency department visit, were more likely to enroll in cardiac rehabilitation, and had modestly higher mortality within 30 or 90 days of discharge. CONCLUSIONS: A third of Medicare beneficiaries undergoing coronary artery bypass grafting used HHC within 30 days of discharge, with wide interhospital variation in use and mixed associations with clinical outcomes and health care utilization.

3.
Article in English | MEDLINE | ID: mdl-38762215

ABSTRACT

BACKGROUND: The quality-adjusted life year (QALY) measures disease burden and treatment, combining overall survival and health-related quality of life (HRQOL). We estimated QALYs in three groups of older patients (60-80 years) with heart failure (HF) who underwent heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS] or HT without pre-transplant MCS [HT Non-MCS]) or long-term MCS (destination therapy). We also identified factors associated with gains in QALYs through 24 months follow-up. METHODS: Of 393 eligible patients enrolled (10/1/15-12/31/18) at 13 U.S. sites, 161 underwent HT (n=68 HT MCS, n=93 HT Non-MCS) and 144 underwent long-term MCS. Survival and HRQOL data were collected through 24 months. QALY health utilities were based on patient self-report of EQ-5D-3L dimensions. Mean-restricted QALYs were compared among groups using generalized linear models. RESULTS: For the entire cohort, mean age in years closest to surgery was 67 (standard deviation, SD: 4.7), 78% were male, and 83% were White. By 18 months post-surgery, sustained significant differences in adjusted average+SD QALYs emerged across groups, with the HT Non-MCS group having the highest average QALYs (24-month window: HT Non-MCS=22.58+1.1, HT MCS=19.53+1.33, Long-term MCS=19.49+1.3, p=0.003). At 24 months post-operatively, a lower gain in QALYs was associated with HT MCS, long-term MCS, a lower pre-operative LVEF, NYHA class III or IV before surgery, and an ischemic or other etiology of HF. CONCLUSIONS: Determination of QALYs may provide important information for policy makers and clinicians to consider regarding benefits of HT and long-term MCS as treatment options for older patients with HF.

4.
Article in English | MEDLINE | ID: mdl-38649110

ABSTRACT

OBJECTIVE: Despite guideline recommendation, cardiac rehabilitation (CR) after cardiac surgery remains underused, and the extent of interhospital variability is not well understood. This study evaluated determinants of interhospital variability in CR use and outcomes. METHODS: This retrospective cohort study included 166,809 Medicare beneficiaries undergoing cardiac surgery who were discharged alive between July 1, 2016, and December 31, 2018. CR participation was identified in outpatient facility claims within a year of discharge. Hospital-level CR rates were tabulated, and multilevel models evaluated the extent to which patient, organizational, and regional factors accounted for interhospital variability. Adjusted 1-year mortality and readmission rates were also calculated for each hospital quartile of CR use. RESULTS: Overall, 90,171 (54.1%) participated in at least 1 CR session within a year of discharge. Interhospital CR rates ranged from 0.0% to 96.8%. Hospital factors that predicted CR use included nonteaching status and lower-hospital volume. Before adjustment for patient, organizational, and regional factors, 19.3% of interhospital variability was attributable to the admitting hospital. After accounting for covariates, 12.3% of variation was attributable to the admitting hospital. Patient (0.5%), structural (2.8%), and regional (3.7%) factors accounted for the remaining explained variation. Hospitals in the lowest quartile of CR use had greater adjusted 1-year mortality rates (Q1 = 6.7%, Q4 = 5.2%, P < .001) and readmission rates (Q1 = 37.6%, Q4 = 33.9%, P < .001). CONCLUSIONS: Identifying best practices among high CR use facilities and barriers to access in low CR use hospitals may reduce interhospital variability in CR use and advance national improvement efforts.

5.
Article in English | MEDLINE | ID: mdl-38522574

ABSTRACT

BACKGROUND: Cardiac rehabilitation (CR) is a guideline-recommended risk-reduction program offered to cardiac surgical patients. Despite CR's association with better outcomes, attendance remains poor. The relationship between discharge location and CR use is poorly understood. METHODS: This study was a nationwide, retrospective cohort analysis of Medicare fee-for-service claims for beneficiaries undergoing coronary artery bypass grafting and/or surgical aortic valve repair between July 1, 2016, and December 31, 2018. The primary outcome was attendance of any CR session. Discharge location was categorized as home discharge or discharge to extended care facility (ECF) (including skilled nursing facility, inpatient rehabilitation, and long-term acute care). Multivariable logistic regression models evaluated the association between discharge location, CR attendance, and 1-year mortality. RESULTS: Of the 167,966 patients who met inclusion criteria, 34.1% discharged to an ECF. Overall CR usage rate was 53.9%. Unadjusted and adjusted CR use was lower among patients discharged ECFs versus those discharged home (42.1% vs 60.0%; adjusted odds ratio, 0.66; P < .001). Patients discharged to long-term acute care were less likely to use CR than those discharged to skilled nursing facility or inpatient rehabilitation (reference category: home; adjusted odds ratio for long-term acute care, 0.36, adjusted odds ratio for skilled nursing facility, 0.69, and adjusted odds ratio for inpatient rehabilitation, 0.71; P < .001). CR attendance was associated with a greater reduction in adjusted 1-year mortality in patients discharged to ECFs (9.7% reduction) versus those discharged home (4.3% reduction). CONCLUSIONS: In this national analysis of Medicare beneficiaries, discharge to ECF was associated with lower CR use, despite a greater association with improved 1-year mortality. Interventions aimed at increasing CR enrollment at ECFs may improve CR use and advance surgical quality.

6.
J Cardiothorac Surg ; 19(1): 83, 2024 Feb 10.
Article in English | MEDLINE | ID: mdl-38336724

ABSTRACT

BACKGROUND: Adult patients surviving with congenital heart disease (ACHD) is growing. We examine the factors associated with heart transplant outcomes in this challenging population with complex anatomy requiring redo-surgeries. METHODS: We reviewed the United Network for Organ Sharing-Standard Transplant Analysis and Research database and analyzed 35,952 heart transplants from January 1st, 2000, to September 30th, 2018. We compared transplant characteristics for ischemic cardiomyopathy (ICM) (n = 14,236), nonischemic cardiomyopathy (NICM) (n = 20,676), and ACHD (n = 1040). Mean follow-up was 6.20 ± 4.84 years. Kaplan-Meier survival curves and Cox-proportional hazards analysis were used to analyze survival data. RESULTS: Multivariable analysis confirmed that ACHD was associated greater in-hospital death compared to ICM (HR = 0.54, P < 0.001) and NICM (HR = 0.46, P < 0.001). Notable factors associated with increased mortality were history of cerebrovascular disease (HR = 1.11, P = 0.026), prior history of malignancy (HR = 1.12, P = 0.006), pre-transplant biventricular support (HR = 1.12, P = 0.069), postoperative stroke (HR = 1.47, P < 0.001) and postoperative dialysis (HR = 1.71, P < 0.001). ACHD transplants had a longer donor heart ischemic time (P < 0.001) and trend towards more deaths from primary graft dysfunction (P = 0.07). In-hospital deaths were more likely with ACHD and use of mechanical support such as use of right ventricular assist device (HR = 2.20, P = 0.049), biventricular support (HR = 1.62, P < 0.001) and extracorporeal membrane oxygenation (HR = 2.36, P < 0.001). Conditional survival after censoring hospital deaths was significantly higher in ACHD (P < 0.001). CONCLUSION: Heart transplant in ACHD is associated with a higher post-operative mortality given anatomical complexity but a better long-term conditional survival. Normothermic donor heart perfusion may improve outcomes in the ACHD population by reducing the impact of longer ischemic times.


Subject(s)
Cardiomyopathies , Heart Defects, Congenital , Heart Transplantation , Adult , Humans , Hospital Mortality , Tissue Donors , Heart Defects, Congenital/surgery , Heart Defects, Congenital/complications , Cardiomyopathies/complications , Retrospective Studies
7.
JTCVS Open ; 17: 121-144, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38420528

ABSTRACT

Objective: Professional standards recommend stopping cardiotomy suction at the termination of cardiopulmonary bypass before protamine administration based on perceived safety concerns. This study evaluated a multidisciplinary collaborative quality-improvement intervention promoting this agreed-upon cardiotomy suction practice during coronary artery bypass grafting (CABG). Methods: A statewide intervention (eg, unblinded surgeon and perfusionist feedback, evidence-based lectures, evaluating barriers to change) involved 32 centers participating in the PERForm (ie, Perfusion Measures and Outcomes) Registry to standardize cardiotomy suction practices at cardiopulmonary bypass termination during CABG. Four non-Michigan registry participating centers were not exposed to collaborative learning. Cardiotomy suction practice was defined as the absence of or stopping cardiotomy suction before protamine administration. The practice changes attributed to the intervention, including Michigan and non-Michigan comparisons, were evaluated with the change of time effect modeled using splines. Multivariable regression was used to evaluate the intervention's associated impact (eg, mortality, reoperation, transfusion). Results: Among 10,394 patients undergoing CABG at Michigan centers, 80.7% achieved agreed-upon cardiotomy suction practices. The Michigan centers had nonsignificant changes in agreed-upon cardiotomy suction practices during the preintervention period (P = .24), with significant increased monthly change in practice thereafter, absent adjusted morbidity and mortality increases. The Michigan centers achieved a significantly greater adjusted monthly improvement in agreed-upon practices relative to non-Michigan centers within 7 months after the intervention (adjusted odds ratio for change of trends: 2.53, P < .001). Conclusions: This initiative demonstrates the effectiveness of multidisciplinary collaborative quality improvement in advancing agreed-upon cardiotomy suction practices without negatively impacting clinical outcomes.

9.
JACC Heart Fail ; 12(3): 438-447, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38276933

ABSTRACT

BACKGROUND: Extended criteria donor (ECD) hearts available with donation after brain death (DBD) are underutilized for transplantation due to limitations of cold storage. OBJECTIVES: This study evaluated use of an extracorporeal perfusion system on donor heart utilization and post-transplant outcomes in ECD DBD hearts. METHODS: In this prospective, single-arm, multicenter study, adult heart transplant recipients received ECD hearts using an extracorporeal perfusion system if hearts met study criteria. The primary outcome was a composite of 30-day survival and absence of severe primary graft dysfunction (PGD). Secondary outcomes were donor heart utilization rate, 30-day survival, and incidence of severe PGD. The safety outcome was the mean number of heart graft-related serious adverse events within 30 days. Additional outcomes included survival through 2 years benchmarked to concurrent nonrandomized control subjects. RESULTS: A total of 173 ECD DBD hearts were perfused; 150 (87%) were successfully transplanted; 23 (13%) did not meet study transplantation criteria. At 30 days, 92% of patients had survived and had no severe PGD. The 30-day survival was 97%, and the incidence of severe PGD was 6.7%. The mean number of heart graft-related serious adverse events within 30 days was 0.17 (95% CI: 0.11-0.23). Patient survival was 93%, 89%, and 86% at 6, 12, and 24 months, respectively, and was comparable with concurrent nonrandomized control subjects. CONCLUSIONS: Use of an extracorporeal perfusion system resulted in successfully transplanting 87% of donor hearts with excellent patient survival to 2 years post-transplant and low rates of severe PGD. The ability to safely use ECD DBD hearts could substantially increase the number of heart transplants and expand access to patients in need. (International EXPAND Heart Pivotal Trial [EXPANDHeart]; NCT02323321; Heart EXPAND Continued Access Protocol; NCT03835754).


Subject(s)
Heart Failure , Heart Transplantation , Adult , Humans , Graft Survival , Heart Failure/surgery , Heart Transplantation/methods , Organ Preservation/methods , Prospective Studies , Retrospective Studies , Tissue Donors
10.
J Am Heart Assoc ; 13(2): e029833, 2024 Jan 16.
Article in English | MEDLINE | ID: mdl-38193303

ABSTRACT

BACKGROUND: Over 20% of patients are discharged to a skilled nursing facility (SNF) after coronary artery bypass graft surgery, but little is known about specific drivers for postdischarge SNF use. The purpose of this study was to evaluate hospital variation in SNF use and its association with postoperative outcomes after coronary artery bypass graft. METHODS AND RESULTS: A retrospective study design utilizing Medicare Provider Analysis and Review files was used to evaluate SNF use among 70 509 beneficiaries undergoing coronary artery bypass graft, with or without valve procedures, between 2016 and 2018. A total of 17 328 (24.6%) were discharged to a SNF, ranging from 0% to 88% across 871 hospitals. Multilevel logistic regression models identified significant patient-level predictors of discharge to SNF including increasing age, comorbidities, female sex, Black race, dual eligibility, and postoperative complications. After adjusting for patient and hospital factors, 15.6% of the variation in hospital SNF use was attributed to the discharging hospital. Compared with the lower quartile of hospital SNF use, hospitals in the top quartile of SNF use had lower risk-adjusted 1-year mortality (12.5% versus 8.6%, P<0.001) and readmission (59.9% versus 49.8%, P<0.001) rates for patients discharged to a SNF. CONCLUSIONS: There is high variability in SNF use among hospitals that is only partially explained by patient characteristics. Hospitals with higher SNF utilization had lower risk-adjusted 1-year mortality and readmission rates for patients discharged to a SNF. More work is needed to better understand underlying provider and hospital-level factors contributing to SNF use variability.


Subject(s)
Patient Discharge , Patient Readmission , Humans , Female , Aged , United States/epidemiology , Retrospective Studies , Medicare , Skilled Nursing Facilities , Aftercare , Hospitals , Coronary Artery Bypass/adverse effects
12.
J Heart Lung Transplant ; 43(4): 604-614, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38065237

ABSTRACT

BACKGROUND: Gastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management. METHODS: The study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS Intermacs registry from January 2017 to December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes and created a risk score to predict the likelihood of post-LVAD GIB based solely on preimplantation factors. RESULTS: Of 6,425 patients who received an HM3 LVAD, 1,010 (15.7%) patients experienced GIB. Thirteen preimplantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3 years postimplant, GIB occurred in 11%, 26%, and 43% of low-, medium- and high-risk patients, respectively. Experiencing 1 post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least 1 recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death. CONCLUSIONS: The Michigan Bleeding Risk Model is a simple tool, which facilitates the prediction of post-LVAD GIB in HM3 recipients using 13 preimplant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients.


Subject(s)
Heart Failure , Heart-Assist Devices , Adult , Humans , Heart Failure/surgery , Michigan/epidemiology , Heart-Assist Devices/adverse effects , Quality of Life , Retrospective Studies , Gastrointestinal Hemorrhage/epidemiology , Gastrointestinal Hemorrhage/etiology
13.
Ann Thorac Surg ; 117(1): 33-44, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37944655

ABSTRACT

The 14th Annual Report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) describes outcomes of 27,493 patients with a continuous-flow left ventricular assist device (LVAD) from the past decade (2013-2022). In 2022, 2517 primary LVADs were implanted, of which 2512 (99.8%) were fully magnetically levitated (Mag-Lev) devices. This shift to nearly exclusive use of a Mag-Lev device led us to examine its outcomes compared with contemporary (2018-2022) and historical (2013-2017) non-Mag-Lev cohorts. Patients supported by a Mag-Lev device (n = 10,920) had a higher 1- and 5-year survival of 86% (vs 79% and 81%, P < .0001) and 64% (vs 44% and 44%, P < .0001), respectively, than those receiving non-Mag-Lev devices during the contemporary and historical eras. Over 5 years, freedom from gastrointestinal bleeding (72% vs 60%, P < .0001), stroke (87% vs 67%, P < .0001), and device malfunction/pump thrombus (83% vs 54%, P < .0001), but not device-related infection (61% vs 64%, P = .93), was higher with Mag-Lev devices compared with non-Mag-Lev support during the contemporary era. In this large primacy cohort of real-world patients with advanced heart failure, this report underscores marked improvements in short- and intermediate-term survival and reduction of adverse events with a contemporary Mag-Lev LVAD.


Subject(s)
Heart Failure , Heart-Assist Devices , Thrombosis , Humans , Heart Failure/surgery , Heart Failure/etiology , Heart-Assist Devices/adverse effects , Societies, Medical , Thrombosis/etiology , Registries , Treatment Outcome
14.
Ann Surg ; 279(5): 891-899, 2024 May 01.
Article in English | MEDLINE | ID: mdl-37753657

ABSTRACT

OBJECTIVE: To associate surgeon-anesthesiologist team familiarity (TF) with cardiac surgery outcomes. BACKGROUND: TF, a measure of repeated team member collaborations, has been associated with improved operative efficiency; however, examination of its relationship to clinical outcomes has been limited. METHODS: This retrospective cohort study included Medicare beneficiaries undergoing coronary artery bypass grafting (CABG), surgical aortic valve replacement (SAVR), or both (CABG+SAVR) between January 1, 2017, and September 30, 2018. TF was defined as the number of shared procedures between the cardiac surgeon and anesthesiologist within 6 months of each operation. Primary outcomes were 30- and 90-day mortality, composite morbidity, and 30-day mortality or composite morbidity, assessed before and after risk adjustment using multivariable logistic regression. RESULTS: The cohort included 113,020 patients (84,397 CABG; 15,939 SAVR; 12,684 CABG+SAVR). Surgeon-anesthesiologist dyads in the highest [31631 patients, TF median (interquartile range)=8 (6, 11)] and lowest [44,307 patients, TF=0 (0, 1)] TF terciles were termed familiar and unfamiliar, respectively. The rates of observed outcomes were lower among familiar versus unfamiliar teams: 30-day mortality (2.8% vs 3.1%, P =0.001), 90-day mortality (4.2% vs 4.5%, P =0.023), composite morbidity (57.4% vs 60.6%, P <0.001), and 30-day mortality or composite morbidity (57.9% vs 61.1%, P <0.001). Familiar teams had lower overall risk-adjusted odds of 30-day mortality or composite morbidity [adjusted odds ratio (aOR) 0.894 (0.868, 0.922), P <0.001], and for SAVR significantly lower 30-day mortality [aOR 0.724 (0.547, 0.959), P =0.024], 90-day mortality [aOR 0.779 (0.620, 0.978), P =0.031], and 30-day mortality or composite morbidity [aOR 0.856 (0.791, 0.927), P <0.001]. CONCLUSIONS: Given its relationship with improved 30-day cardiac surgical outcomes, increasing TF should be considered among strategies to advance patient outcomes.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Aged , United States , Transcatheter Aortic Valve Replacement/methods , Retrospective Studies , Medicare , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Risk Factors , Treatment Outcome
16.
Ann Thorac Surg ; 117(2): 449-455, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37640148

ABSTRACT

BACKGROUND: Evaluating the research productivity of cardiothoracic surgery residents during their training and early career is crucial for tracking their academic development. To this end, the training pathway of residents and the characteristics of their program in relation to their productivity were evaluated. METHODS: Alumni lists from integrated 6-year thoracic surgery (I-6) and traditional thoracic surgery residency programs were collected. A Python script was used to search PubMed for publications and the iCite database for citations from each trainee. Publications during a 20-year time span were stratified by the year of publication in relation to the trainee's graduation from thoracic surgery residency. Trainees were analyzed by training program type, institutional availability of a cardiothoracic surgery T32 training grant, and protected academic development time. RESULTS: A total of 741 cardiothoracic surgery graduates (I-6, 70; traditional, 671) spanning 1971 to 2021 from 57 programs published >23,000 manuscripts. I-6 trainees published significantly more manuscripts during medical school and residency compared with traditional trainees. Trainees at institutions with cardiothoracic surgery T32 training grants published significantly more manuscripts than those at non-T32 institutions (13 vs 9; P = .0048). I-6 trainees published more manuscripts at programs with dedicated academic development time compared with trainees at programs without protected time (22 vs 9; P = .004). CONCLUSIONS: I-6 trainees publish significantly more manuscripts during medical school and residency compared with their traditional colleagues. Trainees at institutions with T32 training grants and dedicated academic development time publish a higher number of manuscripts than trainees without those opportunities.


Subject(s)
Biomedical Research , Internship and Residency , Thoracic Surgery , Thoracic Surgical Procedures , Humans , Education, Medical, Graduate , Thoracic Surgery/education
17.
JAMA ; 330(22): 2171-2181, 2023 12 12.
Article in English | MEDLINE | ID: mdl-37950897

ABSTRACT

IMPORTANCE: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety. OBJECTIVE: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. DESIGN, SETTING, and PARTICIPANTS: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. MAIN OUTCOMES AND MEASURES: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events. RESULTS: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics. CONCLUSIONS AND RELEVANCE: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156.


Subject(s)
Heart Failure , Heart-Assist Devices , Stroke , Thromboembolism , Male , Humans , Female , Aspirin/adverse effects , Heart-Assist Devices/adverse effects , Fibrinolytic Agents/adverse effects , Double-Blind Method , Heart Failure/physiopathology , Stroke/etiology , Stroke/prevention & control , Stroke/drug therapy , Platelet Aggregation Inhibitors/adverse effects , Hemorrhage/etiology , Thromboembolism/etiology , Thromboembolism/prevention & control
18.
Anesthesiol Clin ; 41(4): 803-818, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37838385

ABSTRACT

Nontechnical skills, defined as the set of cognitive and social skills used by individuals and teams to reduce error and improve performance in complex systems, have become increasingly recognized as a key contributor to patient safety. Efforts to characterize, quantify, and teach nontechnical skills in the context of perioperative care continue to evolve. This review article summarizes the essential behaviors for safety, described in taxonomies for nontechnical skills assessments developed for intraoperative clinical team members (eg, surgeons, anesthesiologists, scrub practitioners, perfusionists). Furthermore, the authors describe emerging methods to advance understanding of the impact of nontechnical skills on perioperative outcomes.


Subject(s)
Clinical Competence , Surgeons , Humans , Patient Care Team
20.
Circ Cardiovasc Qual Outcomes ; 16(11): e010148, 2023 11.
Article in English | MEDLINE | ID: mdl-37855157

ABSTRACT

BACKGROUND: Although disparities in cardiac rehabilitation (CR) participation are well documented, the role of community-level distress is poorly understood. This study evaluated the relationship between community-level distress and CR participation, access to CR facilities, and clinical outcomes. METHODS: A retrospective cohort study was conducted on a 100% sample of Medicare beneficiaries undergoing inpatient coronary revascularization between July 2016 and December 2018. Community-level distress was defined using the Distressed Community Index quintile at the beneficiary zip code level, with the first and fifth quintiles representing prosperous and distressed communities, respectively. Outpatient claims were used to identify any CR use within 1 year of discharge. Beneficiary and CR facility zip codes were used to describe access to CR facilities. Adjusted logistic regression models evaluated the association between Distressed Community Index quintiles, CR use, and clinical outcomes, including one-year mortality, all-cause hospitalization, and acute myocardial infarction hospitalization. RESULTS: A total of 414 730 beneficiaries were identified, with 96 929 (23.4%) located in the first and 67 900 (16.4%) in the fifth quintiles, respectively. Any CR use was lower for beneficiaries in distressed compared with prosperous communities (26.0% versus 46.1%, P<0.001), which was significant after multivariable adjustment (odds ratio, 0.41 [95% CI, 0.40-0.42]). A total of 98 458 (23.7%) beneficiaries had a CR facility within their zip code, which increased from 16.3% in prosperous communities to 26.6% in distressed communities. Any CR use was associated with absolute reductions in mortality (-6.8% [95% CI, -7.0% to -6.7%]), all-cause hospitalization (-5.9% [95% CI, -6.3% to -5.6%]), and acute myocardial infarction hospitalization (-1.3% [95% CI, -1.5% to -1.1%]), which were similar across each Distressed Community Index quintiles. CONCLUSIONS: Although community-level distress was associated with lower CR participation, the clinical benefits were universally received. Addressing barriers to CR in distressed communities should be considered a significant priority to improve survival after coronary revascularization and reduce disparities.


Subject(s)
Cardiac Rehabilitation , Myocardial Infarction , Aged , Humans , United States/epidemiology , Retrospective Studies , Architectural Accessibility , Inpatients , Medicare
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