Deactivation of LVAD support for myocardial recovery-surgical perspectives.

Left ventricular assist devices (LVADs) are excellent therapies for advanced heart failure patients either bridged to transplant or for lifetime use. LVADs also allow for reverse remodeling of the failing heart that is often associated with functional improvement. Indeed, growing enthusiasm exists to better understand this population of patients, whereby the LVAD is used as an adjunct to mediate myocardial recovery. When patients achieve benchmarks suggesting that they no longer need LVAD support, questions related to the discontinuation of LVAD therapy become front and center. The purpose of this review is to provide a surgical perspective on the practical and technical issues surrounding LVAD deactivation.

Venoarterial Extracorporeal Life Support Use in Acute Pulmonary Embolism Shows Favorable Outcomes.

BACKGROUND: Differences in outcomes by indication for venoarterial extracorporeal life support (VA-ECLS) are poorly described. We hypothesized that patients on VA-ECLS for acute pulmonary embolism (PE) have fewer complications and better survival than patients on VA-ECLS for other indications. METHODS: All patients ≥18 years on VA-ECLS from the Extracorporeal Life Support Organization global registry (2010-2019) were evaluated (n = 29,842). After excluding patients aged >79 years (n = 729) and those with incomplete indication data (n = 2530), patients were stratified by VA-ECLS indication for PE vs all other indications. The association between being discharged alive and each type of complication with VA-ECLS indication was assessed. RESULTS: Of 26,583 patients included in the analysis, 978 (3.7%) were on VA-ECLS for a primary diagnosis of acute PE. Acute PE patients were younger (53.1 vs 56.7 years, P < .001) and were more likely to be women (52.1% vs 32.3%, P < .001). Patients who underwent VA-ECLS for acute PE were 78% more likely to be discharged alive vs patients supported with VA-ECLS for other reasons (P < .001). Acute PE patients had fewer cardiovascular and renal complications (26.6% vs 38.0% and 31.1% vs 39.4%, respectively; adjusted P < .001). Acute PE patients had higher odds of having clots and mechanical complications (8.7% vs 7.9% and 16.7% vs 14.6%, respectively; adjusted P < .001). CONCLUSIONS: Patients undergoing VA-ECLS for acute PE have higher odds of survival to hospital discharge compared with those supported for other indications. Additionally, VA-ECLS in this population is associated with fewer cardiovascular and renal complications but higher mechanical complications.

Trends in the Use of Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Heart Transplant Patients in Virginia.

OBJECTIVES: To explore trends in intraoperative procoagulant factor concentrate use in patients undergoing heart transplantation (HTx) in Virginia. Secondarily, to evaluate their association with postoperative thrombosis. DESIGN: Patients who underwent HTx were identified using a statewide database. Trends in off-label recombinant activated factor VII (rFVIIa) use and on-label and off-label prothrombin complex concentrate (PCC) use were tested using the Mantel-Haenszel test. Multivariate logistic regression was used to test for an association between procoagulant factor concentrate administration and thrombosis. SETTING: Virginia hospitals performing HTx. PARTICIPANTS: Adults undergoing HTx between 2012 and 2022. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 899 patients who required HTx, 100 (11.1%) received off-label rFVIIa, 69 (7.7%) received on-label PCC, and 80 (8.9%) received off-label PCC. There was a downward trend in the use of rFVIIa over the 10-year period (p = 0.04). There was no trend in on-label PCC use (p = 0.12); however, there was an increase in off-label PCC use (p < 0.001). Patients who received rFVIIa were transfused more and had longer cardiopulmonary bypass time (p < 0.001). Receipt of rFVIIa was associated with increased thrombotic risk (odds ratio [OR] 1.92; 95% CI 1.12-3.29; p = 0.02), whereas on-label and off-label PCC use had no association with thrombosis (OR 0.98, 95% CI 0.49-1.96, p = 0.96 for on-label use; and OR 0.61, 95% CI 0.29-1.30, p = 0.20 for off-label use). CONCLUSIONS: Use of rFVIIa in HTx decreased over the past decade, whereas off-label PCC use increased. Receipt of rFVIIa was associated with thrombosis; however, patients who received rFVIIa were more severely ill, and risk adjustment may have been incomplete.

Outcomes of heparinized adult veno-arterial extracorporeal membrane oxygenation patients managed with low and high activated partial thromboplastin time targets: A systematic review and meta-analysis.

INTRODUCTION: There are no randomized controlled trials comparing low and high activated partial thromboplastin time (aPTT) targets in heparinized adult veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) patients. Our systematic review and meta-analysis summarized complication rates in adult VA ECMO patients treated with low and high aPTT targets. METHODS: Studies published from January 2000 to May 2022 were identified using Pubmed, Embase, Cochrane Library, and LILACS (Latin American and Caribbean Health Sciences Literature). Studies were included if aPTT was primarily used to guide heparin anticoagulation. For the low aPTT group, we included studies where aPTT goal was ≤60 seconds and for the high aPTT group, we included studies where aPTT goal was ≥60 seconds. Proportional meta-analysis with a random effects model was used to calculate pooled complication rates for patients in the two aPTT groups. RESULTS: Twelve studies met inclusion criteria (5 in the low aPTT group and 7 in the high aPTT group). The pooled bleeding complication incidence for low aPTT studies was 53.6% (95% CI = 37.4%-69.4%, I2 = 60.8%) and for high aPTT studies was 43.8% (95% CI = 21.7%-67.1%, I2 = 91.8%). No studies in the low aPTT group reported overall thrombosis incidence, while three studies in the high aPTT group reported overall thrombosis incidence. The pooled thrombosis incidence for high aPTT studies was 16.1% (95% CI = 9.0%-24.5%, I2 = 13.1%). CONCLUSIONS: Adult ECMO patients managed with low and high aPTT goals appeared to have similar bleeding and other complication rates further highlighting the need for a randomized controlled trial.

Extracorporeal Life Support Organization Center of Excellence recognition is associated with improved failure to rescue after cardiac arrest.

OBJECTIVE: The influence of Extracorporeal Life Support Organization (ELSO) center of excellence (CoE) recognition on failure to rescue after cardiac surgery is unknown. We hypothesized that ELSO CoE would be associated with improved failure to rescue. METHODS: Patients undergoing a Society of Thoracic Surgeons index operation in a regional collaborative (2011-2021) were included. Patients were stratified by whether or not their operation was performed at an ELSO CoE. Hierarchical logistic regression analyzed the association between ELSO CoE recognition and failure to rescue. RESULTS: A total of 43,641 patients were included across 17 centers. In total, 807 developed cardiac arrest with 444 (55%) experiencing failure to rescue after cardiac arrest. Three centers received ELSO CoE recognition, and accounted for 4238 patients (9.71%). Before adjustment, operative mortality was equivalent between ELSO CoE and non-ELSO CoE centers (2.08% vs 2.36%; P = .25), as was the rate of any complication (34.5% vs 33.8%; P = .35) and cardiac arrest (1.49% vs 1.89%; P = .07). After adjustment, patients undergoing surgery at an ELSO CoE facility were observed to have 44% decreased odds of failure to rescue after cardiac arrest, relative to patients at non-ELSO CoE facility (odds ratio, 0.56; 95% CI, 0.316-0.993; P = .047). CONCLUSIONS: ELSO CoE status is associated with improved failure to rescue following cardiac arrest for patients undergoing cardiac surgery. These findings highlight the important role that comprehensive quality programs serve in improving perioperative outcomes in cardiac surgery.

Renal recovery in cardiac surgery patients requiring postoperative renal-replacement therapy.

OBJECTIVE: Renal failure after cardiac surgery is associated with increased morbidity and mortality. There is a lack of data examining the rate of renal recovery after patients have started dialysis following cardiac surgery. We aimed to determine the frequency of and time to renal recovery of patients requiring dialysis after cardiac surgery. METHODS: All patients who developed new-onset renal failure requiring dialysis following cardiac surgery at our institution from 2011 to 2022 were included. Renal recovery, time to renal recovery, and mortality at 1 year were merged with patients' Society of Thoracic Surgeons Adult Cardiac Surgery Database files. Kaplan-Meier analysis was used to predict time to renal recovery; we censored patients who died or were lost to follow up. Cox regression was used for risk-adjustment. RESULTS: A total of 312 patients were included in the final analysis. Mortality during index hospital admission was 33% (n = 105), and mortality at 1 year was 45% (n = 141). Of those surviving at 1 year, 69% (n = 118) remained renally recovered. Median renal recovery time was 56 (37-74) days. Accounting for mortality as a competing risk, 51% of patients were predicted to achieve renal recovery. Increasing age (hazard ratio, 0.98; 0.514-0.94, P < .026) and increasing total packed red blood cells (hazard ratio, 0.0958; 0.937-0.987, P < .001) received were found to be significant negative predictors of renal recovery in the Fine-Gray model for subhazard distribution. CONCLUSIONS: More than two-thirds of patients with renal failure who survived the perioperative period had renal recovery within 1 year after surgery. Recovery was driven primarily by postoperative complications rather than comorbidities and intraoperative factors, suggesting renal failure in the postoperative cardiac surgery patient surviving to discharge is unlikely to be permanent.

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.

BACKGROUND: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. OBJECTIVES: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. METHODS: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. RESULTS: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. CONCLUSIONS: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.

Preemptive alcohol septal ablation prior to transcatheter mitral valve replacement.

BACKGROUND: Alcohol septal ablation (ASA) has been shown to increase the neo-left ventricular outflow tract (LVOT) area before transcatheter mitral valve replacement (TMVR) but there is little literature on its success and use with dedicated devices. AIMS: To describe our experience with preemptive ASA to increase the predicted neo-LVOT area and its utility with both dedicated TMVR devices and balloon-expandable valves. METHODS: All patients who underwent ASA for TMVR candidacy in our center between May 2018 and October 2022 and had computed tomography (CT) scans done before and after ASA were included. Each CT was assessed for the minimum predicted neo-LVOT area at end-systole, using a virtual valve of the desired TMVR device for each patient. The primary outcome was an increase in the predicted neo-LVOT area after ASA that was deemed sufficient for safe implantation of the desired TMVR device. The secondary outcome was the absence of acute LVOT obstruction after TMVR. RESULTS: A total of 12 patients underwent ASA and all but 1 (n = 11, 91.6%) achieved the primary outcome of having sufficient predicted neo-LVOT area to proceed with TMVR. The mean increase in neo-LVOT area after ASA was 126 ± 64 mm2 (median 119.5, interquartile range: 65.0-163.5 mm2 ). Two patients (16.7%) required a permanent pacemaker after ASA. Nine patients went on and underwent TMVR with their respective devices and none had LVOT obstruction after the procedure. Among the remaining three patients, one had insufficient neo-LVOT clearance after ASA, one had unrelated mortality before TMVR, and one had advanced heart failure before TMVR. CONCLUSION: In appropriately selected patients and at centers experienced with ASA, preemptive ASA can achieve sufficient neo-LVOT clearance for TMVR with a variety of devices in approximately 90% of patients.

Unplanned postoperative catheterization during admission for coronary artery bypass grafting is neither cheap nor benign, but may rescue patients.

OBJECTIVE: Literature describing outcomes of myocardial ischemia after coronary artery bypass grafting is sparse. We hypothesized these patients had more complications and incurred higher costs of care. METHODS: Using adult cardiac surgery data and cardiac catheterization (CathPCI) data from the Virginia Cardiac Services Quality Initiative, we identified patients who underwent unplanned cardiac catheterization after coronary artery bypass grafting from 2018 to 2021. Adult cardiac surgery data were matched to CathPCI data examining earliest in-hospital catheterization. Patients not requiring catheterization served as the control group. RESULTS: We identified 10,597 patients who underwent isolated coronary artery bypass grafting, of whom 41 of 10,597 underwent unplanned cardiac catheterization. A total of 21 of 41 patients (51%) received percutaneous coronary intervention, most commonly for non-ST-elevation myocardial infarction (n = 7, 33%) and ST-elevation myocardial infarction (n = 6, 29%). Postoperative cardiac arrest occurred in 14 patients (40%). In patients who underwent percutaneous coronary intervention, 14 (67%) had a single lesion, 4 (19%) had 2 lesions, and 3 (14%) had 3 lesions. The left anterior descending artery (38%) was the most frequently intervened upon vessel. Patients who underwent catheterization were more likely to require balloon pump support (26% vs 11%), to have prolonged ventilation (57% vs 20%), to have renal failure (17% vs 7.1%), and to undergo reintubation (37% vs 3.8%, all P < .04). There was no statistical difference in operative mortality (4.9% vs 2.3%, P = .2) or failure to rescue (4.9% vs 1.6%, P = .14). Total costs were higher in patients who underwent unplanned catheterization ($81,293 vs $37,011, P < .001). CONCLUSIONS: Unplanned catheterization after coronary artery bypass grafting is infrequent but associated with more complications and a higher cost of care. Therefore, determination of an association with operative mortality in patients with suspected ischemia after coronary artery bypass grafting requires additional study.

Effect of Cardiopulmonary Bypass on SARS-CoV-2 Vaccination Antibody Levels.

Background Adults undergoing heart surgery are particularly vulnerable to respiratory complications, including COVID-19. Immunization can significantly reduce this risk; however, the effect of cardiopulmonary bypass (CPB) on immunization status is unknown. We sought to evaluate the effect of CPB on COVID-19 vaccination antibody concentration after cardiac surgery. Methods and Results This prospective observational clinical trial evaluated adult participants undergoing cardiac surgery requiring CPB at a single institution. All participants received a full primary COVID-19 vaccination series before CPB. SARS-CoV-2 spike protein-specific antibody concentrations were measured before CPB (pre-CPB measurement), 24 hours following CPB (postoperative day 1 measurement), and approximately 1 month following their procedure. Relationships between demographic or surgical variables and change in antibody concentration were assessed via linear regression. A total of 77 participants were enrolled in the study and underwent surgery. Among all participants, mean antibody concentration was significantly decreased on postoperative day 1, relative to pre-CPB levels (-2091 AU/mL, P<0.001). Antibody concentration increased between postoperative day 1and 1 month post CPB measurement (2465 AU/mL, P=0.015). Importantly, no significant difference was observed between pre-CPB and 1 month post CPB concentrations (P=0.983). Two participants (2.63%) developed symptomatic COVID-19 pneumonia postoperatively; 1 case of postoperative COVID-19 pneumonia resulted in mortality (1.3%). Conclusions COVID-19 vaccine antibody concentrations were significantly reduced in the short-term following CPB but returned to pre-CPB levels within 1 month. One case of postoperative COVID 19 pneumonia-specific mortality was observed. These findings suggest the need for heightened precautions in the perioperative period for cardiac surgery patients.

Temporal Cluster Analysis of Deep Sternal Wound Infection in a Regional Quality Collaborative.

INTRODUCTION: Deep sternal wound infection (DSWI) is a rare complication associated with high mortality. Seasonal variability in surgical site infections has been demonstrated, however, these patterns have not been applied to DSWI. The purpose of this study was to assess temporal clustering of DSWIs. METHODS: All cardiac surgery patients who underwent sternotomy were queried from a regional Society of Thoracic Surgeons database from 17 centers from 2001 to 2019. All patients with the diagnosis of DSWI were then identified. Cluster analysis was performed at varying time intervals (monthly, quarterly, and yearly) at the hospital and regional level. DSWI rates were calculated by year and month, and compared using mixed-effects negative binomial regression. RESULTS: A total of 134,959 patients underwent a sternotomy for cardiac surgery, of whom 469 (0.35%) developed a DSWI. Rates of DSWI per hospital across all years ranged from 0.12% to 0.69%. Collaborative-level rates of DSWIs were the greatest in September (0.44%) and the lowest in January (0.30%). Temporal clustering was not seen across seasonal quarters (high rate in preceeding quarter was not associated with a high rate in the next quarter) (P = 0.39). There were yearly differences across all institutions in the DSWI rates. A downward trend in DSWI rates was seen from 2001 to 2019 (P < 0.001). A difference among hospitals in the cohort was observed (P < 0.001). CONCLUSIONS: DSWI are a rare event within our region. Unlike other surgical site infection, there does not appear to be a seasonal pattern associated with DSWI.

Center case volume is associated with Society of Thoracic Surgeons-defined failure to rescue in cardiac surgery.

OBJECTIVE: Our understanding of the impact of a center's case volume on failure to rescue (FTR) after cardiac surgery is incomplete. We hypothesized that increasing center case volume would be associated with lower FTR. METHODS: Patients undergoing a Society of Thoracic Surgeons index operation in a regional collaborative (2011-2021) were included. After we excluded patients with missing Society of Thoracic Surgeons Predicted Risk of Mortality scores, patients were stratified by mean annual center case volume. The lowest quartile of case volume was compared with all other patients. Logistic regression analyzed the association between center case volume and FTR, adjusting for patient demographics, race, insurance, comorbidities, procedure type, and year. RESULTS: A total of 43,641 patients were included across 17 centers during the study period. Of these, 5315 (12.2%) developed an FTR complication, and 735 (13.8% of those who developed an FTR complication) experienced FTR. Median annual case volume was 226, with 25th and 75th percentile cutoffs of 136 and 284 cases, respectively. Increasing center-level case volume was associated with significantly greater center-level major complication rates but lower mortality and FTR rates (all P values < .01). Observed-to-expected FTR was significantly associated with case volume (P = .040). Increasing case volume was independently associated with decreasing FTR rate in the final multivariable model (odds ratio, 0.87 per quartile; confidence interval, 0.799-0.946, P = .001). CONCLUSIONS: Increasing center case volume is significantly associated with improved FTR rates. Assessment of low-volume centers' FTR performance represents an opportunity for quality improvement.

Influence of heart transplant allocation changes on hospital resource utilization.

Objectives: The 2018 change in the heart transplant allocation system resulted in greater use of temporary mechanical circulatory support. We hypothesized that the allocation change has increased hospital resource utilization, including length of stay and cost. Methods: All heart transplant patients within a regional Society of Thoracic Surgeons database were included (2012-2020). Patients were stratified before and after the transplant allocation changes into early (January 2012-September 2018) and late eras (November 2018-June 2020). Costs were adjusted for inflation and presented in 2020 dollars. Results: Of 535 heart transplants, there were 410 early and 125 late era patients. Baseline characteristics were similar, except for greater lung and valvular disease in the late era. Fewer patients in the late era were bridged with durable left ventricular assist devices (69% vs 31%; P < .0001), biventricular devices (5% vs 1%; P = .047), and more with temporary mechanical circulatory support (4% vs 46%; P < .0001). There was no difference in early mortality (6% vs 4%; P = .33) or major morbidity (57% vs 61%; P = .40). Length of stay was longer preoperatively (1 vs 9 days; P < .0001), but not different postoperatively. There was no difference in median total hospital cost ($132,465 vs $128,996; P = .15), although there was high variability. On multivariable regression, preoperative extracorporeal membrane oxygenation utilization was the main driver of resource utilization. Conclusions: The new heart transplant allocation system has resulted in different bridging techniques, with greater reliance on temporary mechanical circulatory support. Although this is associated with an increase in preoperative length of stay, it did not translate into increased hospital cost.

Off-Hours Intensive Care Unit Transfer Is Associated With Increased Mortality and Failure to Rescue.

BACKGROUND: Cardiac postoperative intensive care unit (ICU) beds are a limited resource, and when a patient no longer requires this level of care they are quickly transferred out. We hypothesized that complications and ICU readmission increased when transfer occurred during off-hours compared with regular work hours. METHODS: From 2010 to 2021, patients who underwent a Society of Thoracic Surgeons index operation at a single center were assigned a group based on their ICU transfer time, defined as when they physically arrived on the acute care floor. Patients were stratified into off-hours vs regular hours by their transfer time. Off-hours was defined as 9 pm to 5 am. Risk-adjusted multivariable logistic regression analyzed the association of ICU readmission, postoperative complications, operative mortality, and failure to rescue by group. RESULTS: The cohort included 5951 patients (off-hours n = 292 [4.9%], regular-hours n = 5659 [95.1%]). Patients in the off-hours group had significantly greater odds of risk-adjusted ICU readmission (odds ratio 1.99, 95% CI 1.25-3.04, P < .002) and mortality (odds ratio 3.88, 95% CI 2.27-6.33, P < .001). In the major complications subgroup (Off-hours n = 55, Regular-hours n = 603), Off-hours transfer was associated with increased mortality (failure to rescue) (odds ratio 3.05, 95% CI 1.58-5.69, P = .001). CONCLUSIONS: Off-hours ICU to floor transfer was associated with increased postoperative complications, ICU readmission, and mortality, suggesting that the timing of ICU transfer may impact outcomes. This elucidates targets for quality and process improvement for our center and others facing the same resource constraints.

Pulmonary Hypertension and Operative Risk in Mitral Valve and Coronary Surgery.

INTRODUCTION: Pulmonary hypertension (PHT) is a known risk factor for coronary artery bypass grafting (CABG), though less well understood for valve operations. We hypothesized PHT is associated with lower risk during mitral valve operations compared to CABG. METHODS: Patients undergoing isolated mitral valve or CABG operations (2011-2019) in a regional Society of Thoracic Surgeons (STS) database were stratified by pulmonary artery systolic pressure (PASP). The association of PASP by procedure type was assessed by hierarchical regression modeling, adjusting for STS predicted risk scores. RESULTS: Of the 2542 mitral and 11,059 CABG patients, the mitral population had higher mean STS risk of mortality (3.6% versus 2.4%, P < 0.0001) and median PASP (42 mmHg versus 32 mmHg, P < 0.0001). PASP was independently associated with operative mortality and major morbidity in both mitral and CABG patients. However, for mitral patients a 10-mmHg increase in PASP was associated with lower odds of morbidity (odds ratio: 1.06 versus 1.13), mortality (odds ratio: 1.11 versus 1.18) and intensive care unit time (4.3 versus 7.6 h) compared with CABG patients (interaction terms P < 0.0001). Among mitral patients, median PASP was higher in stenotic versus regurgitant disease (57 mmHg versus 40 mmHg, P < 0.0001). However, there was no differential association of PASP on morbidity or mortality (interaction terms P > 0.05). CONCLUSIONS: Although mitral surgery patients tend to have higher preoperative pulmonary artery pressures, PHT was associated with a lower risk for mitral outcomes compared with CABG. Further research on the management and optimization of patients with PHT perioperatively is needed to improve care for these patients.

Long term employment following heart transplantation in the United States.

BACKGROUND: Employment is an important metric of post-transplant functional status and the quality of life yet remains poorly described after heart transplant. We sought to characterize the prevalence of employment following heart transplantation and identify patients at risk for post-transplant unemployment. METHODS: Adults undergoing single-organ heart transplantation (2007-2016) were evaluated using the UNOS database. Univariable analysis was performed after stratifying by employment status at 1-year post-transplant. Fine-Gray competing risk regression was used for risk adjustment. Cox regression evaluated employment status at 1 year with mortality. RESULTS: Of 10,132 heart transplant recipients who survived to 1 year and had follow-up, 22.0% were employed 1-year post-transplant. Employment rate of survivors increased to 32.9% by year 2. Employed individuals were more likely white (70.8% vs 60.4%, p < 0.01), male (79.6% vs 70.7% p < 0.01), held a job at listing/transplant (37.6% vs 7.6%, p < 0.01), and had private insurance (79.1% vs 49.5%, p < 0.01). Several characteristics were independently associated with employment including age, employment status at time of listing or transplant, race and ethnicity, gender, insurance status, education, and postoperative complications. Of 1,657 (14.0%) patients employed pretransplant, 58% were working at 1-year. Employment at 1year was independently associated with mortality with employed individuals having a 26% decreased risk of mortality. CONCLUSION: Over 20% of heart transplant patients were employed at 1 year and over 30% at 2 years, while 58% of those working pretransplant had returned to work by 1-year. While the major predictor of post-transplant employment is preoperative employment status, our study highlights the impact of social determinants of health.

Cardiac Surgery Outcomes During the COVID-19 Pandemic Worsened Across All Socioeconomic Statuses.

BACKGROUND: Increasing socioeconomic distress has been associated with worse cardiac surgery outcomes. The extent to which the pandemic affected cardiac surgical access and outcomes remains unknown. We sought to examine the relationship between the COVID-19 pandemic and outcomes after cardiac surgery by socioeconomic status. METHODS: All patients undergoing a Society of Thoracic Surgeons (STS) index operation in a regional collaborative, the Virginia Cardiac Services Quality Initiative (2011-2022), were analyzed. Patients were stratified by timing of surgery before vs during the COVID-19 pandemic (March 13, 2020). Hierarchic logistic regression assessed the relationship between the pandemic and operative mortality, major morbidity, and cost, adjusting for the Distressed Communities Index (DCI), STS predicted risk of mortality, intraoperative characteristics, and hospital random effect. RESULTS: A total of 37,769 patients across 17 centers were included. Of these, 7269 patients (19.7%) underwent surgery during the pandemic. On average, patients during the pandemic were less socioeconomically distressed (DCI 37.4 vs DCI 41.9; P < .001) and had a lower STS predicted risk of mortality (2.16% vs 2.53%, P < .001). After risk adjustment, the pandemic was significantly associated with increased mortality (odds ratio 1.398; 95% CI, 1.179-1.657; P < .001), cost (+$4823, P < .001), and STS failure to rescue (odds ratio 1.37; 95% CI, 1.10-1.70; P = .005). The negative impact of the pandemic on mortality and cost was similar regardless of DCI. CONCLUSIONS: Across all socioeconomic statuses, the pandemic is associated with higher cost and greater risk-adjusted mortality, perhaps related to a resource-constrained health care system. More patients during the pandemic were from less distressed communities, raising concern for access to care in distressed communities.

COMPETENCE Trial: The EVAHEART 2 continuous flow left ventricular assist device.

BACKGROUND: Continuous flow left ventricular assist devices have improved outcomes in patients with end-stage heart failure that require mechanical circulatory support. Current devices have an adverse event profile that has hindered widespread application. The EVAHEART®2 left ventricular assist device (EVA2) has design features such as large blood gaps, lower pump speeds and an inflow cannula that does not protrude into the left ventricle that may mitigate the adverse events currently seen with other continuous flow devices. METHODS: A prospective, multi-center randomized non-inferiority study, COMPETENCE Trial, is underway to assess non-inferiority of the EVA2 to the HeartMate 3 LVAS when used for the treatment of refractory advanced heart failure. The primary end-point is a composite of the individual primary outcomes: Survival to cardiac transplant or device explant for recovery; Free from disabling stroke; Free from severe Right Heart Failure after implantation of original device. Randomization is in a 2:1 (EVA2:HM3) ratio. RESULTS: The first patient was enrolled into the COMPETENCE Trial in December of 2020, and 25 subjects (16 EVA2 and 9 HM3) are currently enrolled. Enrollment of a safety cohort is projected to be completed by third quarter of 2022 at which time an interim analysis will be performed. Short-term cohort (92 EVA2 subjects) and long-term cohort is expected to be completed by the end of 2023 and 2024, respectively. CONCLUSIONS: The design features of the EVA2 such as a novel inflow cannula and large blood gaps may improve clinical outcomes but require further study. The ongoing COMPETENCE trial is designed to determine if the EVA2 is non-inferior to the HM3.

Changes in Controllable Coronary Artery Bypass Grafting Practice for White and Black Americans.

BACKGROUND: Racial disparities in outcomes after cardiac surgery are well reported. We sought to determine whether variation by race exists in controllable practices during coronary artery bypass graft surgery (CABG). We hypothesized that racial disparities exist in CABG quality metrics, but have improved over time. METHODS: All patients undergoing isolated CABG (2000 to 2019) in a multiple state database were stratified into three eras by race. Analysis included propensity matched White Americans and Black Americans. Primary outcomes included left internal mammary artery use, multiple arterial grafting, revascularization completeness, and guideline-directed medication prescription. RESULTS: Of 72 248 patients undergoing CABG, Black American patients (n = 10 270, 15%) had higher rates of diabetes mellitus, hypertension, prior stroke, and myocardial infarction. After matching, 19 806 patients (n = 9903 per group) were well balanced. Left internal mammary artery use was significantly different early (era 1, Black Americans 84.7% vs White Americans 86.6%; P = .03), but equalized over time. Importantly, multiarterial grafting differed between Black Americans and White Americans over the entire study (9.1% vs 11.5%, P < .001) and within each era. Black Americans had more incomplete revascularization during the study period (14% vs 12.8%, P = .02) driven by a large disparity in era 1 (9.5% vs 7.2%, P < .001). Despite similar rates of preoperative use, Black Americans were more often discharged on a regimen of ß-blockers (91.8% vs 89.6%, P < .001). CONCLUSIONS: Coronary artery bypass graft surgery metrics of left internal mammary artery use and optimal medical therapy have improved over time and are similar despite patient race. Black Americans undergo less frequent multiarterial grafting and greater discharge ß-blocker prescription. Identifying changes in controllable CABG quality practices across races supports a continued focus on standardizing such efforts.

Socioeconomic Distress Associated With Increased Use of Percutaneous Coronary Intervention Over Coronary Artery Bypass Grafting.

BACKGROUND: The influence of socioeconomic determinants of health on choice of percutaneous coronary intervention (PCI) vs coronary artery bypass grafting (CABG) for coronary artery disease is unknown. We hypothesized that higher Distressed Communities Index (DCI) scores, a comprehensive socioeconomic ranking by zip code, would be associated with more frequent PCI. METHODS: All patients undergoing isolated CABG or PCI in a regional American College of Cardiology CathPCI registry and The Society of Thoracic Surgeons database (2018-2021) were assigned DCI scores (0 = no distress, 100 = severe distress) based on education level, poverty, unemployment, housing vacancies, median income, and business growth. Patients who presented with ST-segment elevation myocardial infarction or emergent procedures were excluded. The most distressed quintile (DCI ≥80) was compared with all other patients. Multivariable logistic regression analyzed the association between DCI and procedure type. RESULTS: A total of 23 223 patients underwent either PCI (n = 16 079) or CABG (n = 7144) for coronary artery disease across 28 centers during the study period. Before adjustment, high socioeconomic distress occurred more frequently among CABG patients (DCI ≥80, 12.4% vs 8.42%; P < .001). After multivariable adjustment, high socioeconomic distress was associated with greater odds of receiving PCI, relative to CABG (odds ratio 1.26; 95% CI, 1.07-1.49; P = .007). High socioeconomic distress was significantly associated with postprocedural mortality (odds ratio 1.52; 95% CI, 1.02-2.26; P = .039). CONCLUSIONS: High socioeconomic distress is associated with greater risk-adjusted odds of receiving PCI, relative to CABG, as well as higher postprocedural mortality. Targeted resource allocation in high DCI areas may help eliminate barriers to CABG.