Transplantation Outcomes with Donor Hearts after Circulatory Death.

BACKGROUND: Data showing the efficacy and safety of the transplantation of hearts obtained from donors after circulatory death as compared with hearts obtained from donors after brain death are limited. METHODS: We conducted a randomized, noninferiority trial in which adult candidates for heart transplantation were assigned in a 3:1 ratio to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group). The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation. RESULTS: A total of 180 patients underwent transplantation; 90 (assigned to the circulatory-death group) received a heart donated after circulatory death and 90 (regardless of group assignment) received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor). The risk-adjusted 6-month survival in the as-treated population was 94% (95% confidence interval [CI], 88 to 99) among recipients of a heart from a circulatory-death donor, as compared with 90% (95% CI, 84 to 97) among recipients of a heart from a brain-death donor (least-squares mean difference, -3 percentage points; 90% CI, -10 to 3; P<0.001 for noninferiority [margin, 20 percentage points]). There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation. CONCLUSIONS: In this trial, risk-adjusted survival at 6 months after transplantation with a donor heart that had been reanimated and assessed with the use of extracorporeal nonischemic perfusion after circulatory death was not inferior to that after standard-care transplantation with a donor heart that had been preserved with the use of cold storage after brain death. (Funded by TransMedics; ClinicalTrials.gov number, NCT03831048.).

Neighborhood Socioeconomic Status and Readmission in Acute Type A Aortic Dissection Repair.

INTRODUCTION: We examined the association of socioeconomic status as defined by median household income quartile (MHIQ) with mortality and readmission patterns following open repair of acute type A aortic dissection (ATAAD) in a nationally representative registry. METHODS: Adults who underwent open repair of ATAAD were selected using the US Nationwide Readmissions Database and stratified by MHIQ. Patients were selected based on diagnostic and procedural codes. The primary endpoint was 30-d readmission. RESULTS: Between 2016 and 2019, 10,288 individuals (65% male) underwent open repair for ATAAD. Individuals in the lowest income quartile were younger (median: 60 versus 64, P < 0.05) but had greater Elixhauser comorbidity burden (5.9 versus 5.7, P < 0.05). Across all groups, in-hospital mortality was approximately 15% (P = 0.35). On multivariable analysis adjusting for baseline comorbidity burden, low socioeconomic status was associated with increased readmission at 90 d, but not at 30 d. Concomitant renal disease (odds ratio [OR], 1.68; P < 0.001), pulmonary disease (OR, 1.26; P < 0.001), liver failure (OR 1.2, P = 0.04), and heart failure (OR, 1.17; P < 0.001) were all associated with readmission at 90 d. The primary indication for readmission was most commonly cardiac (33%), infectious (16.5%), and respiratory (9%). CONCLUSIONS: In patients who undergo surgery for ATAAD, lower MHIQ was associated with higher odds of readmission following open repair. While early readmission for individuals living in the lowest income communities is likely attributable to greater baseline comorbidity burden, we observed that 90-d readmission rates are associated with lower MHIQ regardless of comorbidity burden. Further investigation is required to determine which patient-level and system-level interventions are needed to reduce readmissions in the immediate postoperative period for resource poor areas.

Association of Novel Ventricular Assist Device Self-report Measures With Overall Health-Related Quality of Life.

BACKGROUND: Few study authors examined factors influencing health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) implantation. OBJECTIVE: The purpose of this study was to determine whether 5 novel self-report measures and other variables were significantly associated with overall HRQOL at 3 months after LVAD surgery. METHODS: Patients were recruited between October 26, 2016, and February 29, 2020, from 12 US sites. Data were collected before LVAD implantation and at 3 months post LVAD implantation. Overall HRQOL measures included the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score (OSS) and EuroQol 5-dimension- 3L visual analog scale. Potential factors associated with overall HRQOL included 5 novel self-report measures (Satisfaction with Treatment, Being Bothered by VAD Self-care and Limitations, VAD Team Communication, Self-efficacy regarding VAD Self-care, and Stigma), and demographic and clinical characteristics. Statistics included regression analyses. RESULTS: Of enrollees, 242 completed self-report measures at baseline, and 142 completed measures 3 months postoperatively. Patients were 55 ± 13 years old, with 21% female, 24% non-White, 39% high school or lower educated, and 47% destination therapy. Using the KCCQ-12 OSS, higher Satisfaction with Treatment was associated with a higher KCCQ-12 OSS; Being Bothered by VAD Self-care and Limitations, high school or lower education, chest incision pain, cardiac dysrhythmias within 3 postoperative months, and peripheral edema were associated with a worse KCCQ-12 OSS (R2 = 0.524). Factors associated with a worse 3-month EuroQol 5-dimension-3L visual analog scale were female sex, adverse events within 3 months post implantation (cardiac dysrhythmias, bleeding, and venous thrombosis), and chest incision pain (R2 = 0.229). No factors were associated with a higher EuroQol 5-dimension-3L visual analog scale score at 3 months. CONCLUSIONS: Two novel measures, demographics, postimplantation adverse events, and symptoms were associated with post-LVAD KCCQ-12 OSS early after surgery.

Implementation of a direct-to-operating room aortic emergency transfer program: Expedited management of type A aortic dissection.

INTRODUCTION: Type A Aortic Dissection (TAAD) is a surgical emergency with a time-dependent rate of mortality. We hypothesized that a direct-to-operating room (DOR) transfer program for patients with TAAD would reduce time to intervention. METHODS: A DOR program was started at an urban tertiary care hospital in February 2020. We performed a retrospective study of adult patients undergoing treatment for TAAD before (n = 42) and after (n = 84) implementation of DOR. Expected mortality was calculated using the International Registry of Acute Aortic Dissection risk prediction model. RESULTS: Median time from acceptance of transfer from emergency physician to operating room arrival was 1.37 h (82 min) faster in DOR compared to pre-DOR (1.93 h vs 3.30 h, p < 0.001). Median time from arrival to operating room was 1.14 h (72 min) faster after DOR compared to pre-DOR (0.17 h vs 1.31 h, p < 0.001). In-hospital mortality was 16.2% in pre-DOR, with an observed-to-expected (O/E) ratio of 1.03 (p = 0.24) and 12.0% in the DOR group, with an O/E ratio of 0.59 (p < 0.001). CONCLUSION: Creation of a DOR program resulted in decreased time to intervention. This was associated with a decrease in observed-to-expected operative mortality. The transfer of patients with acute type A aortic dissection to centers with direct-to-OR programs may result in decreased time from diagnosis to surgery.

Limb ischemia and bleeding in patients requiring venoarterial extracorporeal membrane oxygenation.

OBJECTIVE: Acute limb ischemia (ALI) and cannulation site bleeding are frequent complications of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) and are associated with worse outcomes. The goals of this study were to assess our rates of ECMO-related ALI and bleeding and to evaluate the efficacy of strategies to prevent them, such as distal perfusion cannula (DPC) and ultrasound-guided cannulation. METHODS: This is a single-center retrospective cohort study of adult patients placed on peripheral VA-ECMO at a tertiary medical center between 2014 and 2018. ALI was defined as new ischemia of the extremity ipsilateral to arterial cannulation. Significant cannulation site bleeding was defined as excessive bleeding requiring intervention (eg, transfusion or reoperation). Univariate analyses were used to identify factors associated with ALI, bleeding, and in-hospital mortality. RESULTS: During the study period, 105 patients were placed on peripheral VA-ECMO (61.3% female; mean age, 54.9 ± 14.8 years). Nearly half (46.6%) had ECMO implantation in an extracorporeal cardiopulmonary resuscitation setting and 37 (44.0%) had a DPC. Average duration of support was 5.6 ± 5.0 days. Overall in-hospital mortality and death on ECMO support were 65.1% and 50%, respectively. ALI occurred in 21 (20%) and cannulation-related bleeding occurred in 24 (22.9%) patients who were treated with a total of 27 procedures, including thromboembolectomy (22.2%), vascular repair (18.5%), and fasciotomy (25.9%). On univariate analysis, cannulation in the operating room (odds ratio [OR], 0.25; 95% confidence interval [CI], 0.08-0.77; P = .02) was associated with decreased risk of ALI, whereas cannulation in the operating room (OR, 2.65; 95% CI, 1.09-6.45; P = .03) and cutdown approach (OR, 4.96; 95% CI, 2.32-10.61; P < .0001) were associated with increased risk of bleeding. Ultrasound-guided placement was associated with decreased risk of bleeding (OR, 0.81; 95% CI, 0.04-0.84; P = .03). DPC was not associated with either ALI (P = .47) or bleeding (P = .06). ALI (OR, 2.68; 95% CI 1.03-6.98; P = .04), age (OR, 1.94; 95% CI, 1.03-3.69; P = .04), and worse baseline heart failure (OR, 2.01; 95% CI, 1.02-3.97; P = .04) were associated with greater risk of in-hospital mortality. Ultrasound-guided cannulation (OR, 0.41; 95% CI, 0.20-0.87; P = .02) was associated with decreased risk of in-hospital mortality. CONCLUSIONS: ALI and significant bleeding are common occurrences after peripheral VA-ECMO cannulation. Whereas DPC placement did not significantly decrease risk of ALI, ultrasound-guided cannulation decreased the risk of bleeding. Cannulation in the operating room is associated with decreased risk of ALI at the expense of increased risk of bleeding. ALI, older age (≥65 years), and worse heart failure increased risk of in-hospital mortality.

Ankle-brachial index to monitor limb perfusion in patients with femoral venoarterial extracorporeal membrane oxygenation.

BACKGROUND: Limb ischemia is a major complication of femoral venoarterial extracorporeal membrane oxygenation (VA-ECMO). Use of ankle-brachial index (ABI) to monitor limb perfusion in VA-ECMO has not been described. We report our experience monitoring femoral VA-ECMO patients with serial ABI and the relationships between ABI and near infrared spectroscopy (NIRS). METHODS: This is a retrospective single-center review of consecutive adult patients placed on femoral VA-ECMO between January 2019 and October 2019. Data were collected on patients with paired ABI and NIRS values. Relationships between NIRS and ABI of the cannulated (E-NIRS and E-ABI) and non-cannulated legs (N-NIRS and N-ABI) along with the difference between legs (d-NIRS and d-ABI) were determined using Pearson correlation. RESULTS: Overall, 22 patients (mean age 56.5 ± 14.0 years, 72.7% male) were assessed with 295 E-ABI and E-NIRS measurements, and 273 N-ABI and N-NIRS measurements. Mean duration of ECMO support was 129.8 ± 78.3 h. ECMO-mortality was 13.6% and in-hospital mortality was 45.5%. N-ABI and N-NIRS were significantly higher than their ECMO counterparts (ABI mean difference 0.16, 95% confidence interval [CI]: 0.13-0.19, p < .0001; NIRS mean difference 2.51, 95% CI: 1.48-3.54, p < .0001). There was no correlation between E-ABI versus E-NIRS (r = .032, p = .59), N-ABI versus N-NIRS (r = .097, p = .11), or d-NIRS versus d-ABI (r = .11, p = .069). CONCLUSION: ABI is a quantitative metric that may be used to monitor limb perfusion and supplement clinical exams to identify limb ischemia in femorally cannulated VA-ECMO patients. More studies are needed to characterize the significance of ABI in femoral VA-ECMO and its value in identifying limb ischemia in this patient population.

Outcomes of 3-day discharge after elective cardiac surgery.

BACKGROUND: Shorter length of stay (LOS) is a welcome consequence of optimized perioperative care. However, accelerated hospital discharge may have unintended consequences. Before implementing an institutional enhanced recovery after surgery protocol, we evaluated the safety of shorter LOS and compared outcomes of patients with shorter LOS (LOS ≤ 3 days) to those with longer LOS (LOS > 3 days). METHODS: We identified all patients undergoing elective cardiac surgery with cardiopulmonary bypass between July 2004 and June 2017. Transcatheter approaches, ventricular assist devices, transplants, and traumas were excluded. Patients were divided into two cohorts, one with shorter hospitalizations (LOS ≤ 3 days) and one with longer hospitalizations (LOS > 3 days). Propensity score matching (PSM) was performed and differences between the two groups were compared. RESULTS: A total of 5,987 patients (63.0 ± 13.8 years old, 34% female) were identified and 131 (2.2%) patients were LOS ≤ 3 days; median STS Risk score was 1.2 (0.6-2.4). PSM resulted in a total of 478 patients (357 LOS > 3 and 121 LOS ≤ 3 days); median STS Risk score was 0.4 (0.3-0.9). LOS ≤ 3 days had lower rates of postoperative atrial fibrillation (2% vs. 19%; p < .001) and major in-hospital complications (0% vs. 9%; p = .001); however, 30-day readmissions (8% LOS ≤ 3 vs. 6% LOS > 3 days; p = .66) and mortality rates (0% vs. 0%) were comparable between the two groups. CONCLUSION: LOS ≤ 3 days was associated with less postoperative atrial fibrillation and fewer major in-hospital complications. LOS ≤ 3 days was not associated with rehospitalization or mortality. Shorter LOS after elective cardiac surgery appears to be a safe practice with favorable outcomes, especially in low operative risk patients.

Mechanical Circulatory Support Devices for Acute Right Ventricular Failure.

Right ventricular (RV) failure remains a major cause of global morbidity and mortality for patients with advanced heart failure, pulmonary hypertension, or acute myocardial infarction and after major cardiac surgery. Over the past 2 decades, percutaneously delivered acute mechanical circulatory support pumps specifically designed to support RV failure have been introduced into clinical practice. RV acute mechanical circulatory support now represents an important step in the management of RV failure and provides an opportunity to rapidly stabilize patients with cardiogenic shock involving the RV. As experience with RV devices grows, their role as mechanical therapies for RV failure will depend less on the technical ability to place the device and more on improved algorithms for identifying RV failure, patient monitoring, and weaning protocols for both isolated RV failure and biventricular failure. In this review, we discuss the pathophysiology of acute RV failure and both the mechanism of action and clinical data exploring the utility of existing RV acute mechanical circulatory support devices.

Pulmonary Artery Pulsatility Index Is Associated With Right Ventricular Failure After Left Ventricular Assist Device Surgery.

BACKGROUND: Right ventricular failure (RVF) is a major cause of morbidity and mortality after CF-LVAD implantation. We explored the association of pulmonary artery compliance (PAC), pulmonary artery elastance (PAE), and pulmonary artery pulsatility index (PAPi) in addition to established parameters as preoperative determinants of postoperative RVF after CF-LVAD surgery. METHODS AND RESULTS: We retrospectively reviewed 132 consecutive CF-LVAD implantations at Tufts Medical Center from 2008 to 2013. Clinical, hemodynamic, and echocardiographic data were studied. RVF was defined as the unplanned need for a right ventricular assist device or inotrope dependence for ≥14 days. Univariate analysis was performed. RVF occurred in 32 of 132 patients (24%). PAC and PAE were not changed, whereas the PAPi was lower among patients with versus without postoperative RVF (1.32 ± 0.46 vs 2.77 ± 1.16; P < .001). RA pressure, RA to pulmonary capillary wedge pressure ratio (RA:PCWP), and RV stroke work index (RVSWI) were also associated with RVF. Using receiver operating characteristic curve-derived cut-points, PAPi < 1.85 provided 94% sensitivity and 81% specificity (C-statistic = 0.942) for identifying RVF and exceeded the predictive value of RA:PCWP, RVSWI, or RA pressure alone. CONCLUSIONS: PAPi is a simple hemodynamic variable that may help to identify patients at high risk of developing RVF after LVAD implantation.

Preoperative Determinants of Quality of Life and Functional Capacity Response to Left Ventricular Assist Device Therapy.

BACKGROUND: Left ventricular assist devices (LVADs) improve survival, quality of life (QOL), and functional capacity (FC) among patients with end-stage heart failure. Few data are available regarding characteristics associated with QOL and FC response. METHODS AND RESULTS: Patients enrolled in the Heartmate II clinical trials that were alive with ongoing LVAD support at 6 months were included. QOL response criteria included scoring above the lowest quartile on either the Minnesota Living With Heart Failure Questionnaire or the Kansas City Cardiomyopathy Questionnaire. FC responder criteria included improvement in 6-minute walk distance (6MWD) >70 meters from baseline, a 6MWD >220 meters at 6 months, or New York Heart Association functional class I or II. Independent variables associated with QOL nonresponse included history of diabetes (odds ratio [OR] 1.82, 95% confidence interval [CI] 1.20-2.78), lower mean pulmonary arterial pressure (OR 0.97, 95% CI 0.95-0.99), or a Heartmate II right ventricular risk score >2 (OR 1.77, 95% CI 1.00-3.12). Variables associated with FC nonresponse included history of COPD (OR 1.92, 95% CI 1.22-3.03) or diabetes (OR 1.52, 95% CI 1.01-2.27). Compared with responders, QOL and FC nonresponders had reduced long-term survival. CONCLUSIONS: Preoperative comorbidities, including diabetes, COPD, and right heart failure, may limit the QOL and FC response to LVAD therapy and should be considered during the shared decision-making process.

Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.

BACKGROUND: Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail. METHODS AND RESULTS: Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P=0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2-3.3; P=0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8-4.8, P<0.0001]) as independent predictors while concurrent tricuspid valve procedures (TVP) were not predictors. Furthermore, patients with significant preimplant tricuspid regurgitation who did not receive a TVP experienced an increased rate of late RHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P=0.024). CONCLUSIONS: Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972.

Preoperative three-dimensional echocardiography to assess risk of right ventricular failure after left ventricular assist device surgery.

BACKGROUND: Right ventricular failure (RVF) is associated with significant morbidity after left ventricular assist device (LVAD) surgery. Hemodynamic, clinical, and 2-dimensional echocardiographic variables poorly discriminate patients at risk of RVF. We examined the utility of 3-dimensional echocardiography (3DE) right ventricular (RV) volumetric assessment to identify patients at risk for RVF. METHODS AND RESULTS: RVF was defined as the need for inotropic infusion for >14 days after LVAD surgery or the need for biventricular assist device support. Preoperative RV volumes and ejection fraction (EF) were measured, blinded to clinical data, from transthoracic 3DE full volume data sets in 26 patients. Baseline variables and 3DE RV indices were compared between patients with and without RVF. Twenty-four patients received continuous-flow LVADs, and 2 required biventricular support devices. Ten patients required prolonged inotropes after LVAD placement. Baseline characteristics associated with RVF included higher right atrial pressure, higher right atrial pressure to pulmonary capillary wedge pressure ratio, and lower cardiac index and RV stroke work index (RVSWI). Echocardiographic indices associated with RVF included 3DE indexed RV end-diastolic and end-systolic volumes (RVEDVI and RVESVI) and RV ejection fraction (RVEF). The relationship between 3DE quantification of RV volumes and the development of RVF was independent from RVSWI: RVEDVI: odds ratio (OR) 1.16, 95% confidence interval (CI) 1.00-1.33 (P = .04); RVESVI: OR 1.14, 95% CI 1.01-1.28 (P = .03). CONCLUSIONS: Quantitative 3DE is a promising method for pre-LVAD RV assessment. RV volumes assessed by 3DE are predictive of RVF in LVAD recipients independently from hemodynamic correlates of RV function.

Percutaneous bi-atrial extracorporeal membrane oxygenation for acute circulatory support in advanced heart failure.

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) may improve survival after cardiac arrest by providing cardiopulmonary support. However, VA-ECMO increases left ventricular (LV) afterload, which can promote progressive LV distension and often requires a secondary approach to reduce LV pressure and volume in patients with left heart failure. We report a case of biventricular unloading via biatrial cannulation in the presence of LV thrombus using a TandemHeart percutaneous trans-septal cannula for VA-ECMO in an adult patient with refractory ventricular fibrillation.

Pulmonary artery mass with PIK3CA mutation after orthotopic heart transplantation.

BACKGROUND: Patients can develop de novo malignancies following orthotopic heart transplantation. However, vascular tumors are not commonly described in this population. CASE PRESENTATION: We present a 69-year-old female with a history of orthotopic heart transplantation for chemotherapy-induced cardiomyopathy who developed an incidental pulmonary artery mass six years after her transplantation. Given concerns for malignancy, the patient underwent an operative excisional biopsy through a left anterior mini-thoracotomy with femoral artery and vein cannulation for cardiopulmonary bypass. The mass was determined to be a non-malignant vascular overgrowth with PIK3CA mutation. CONCLUSION: We present the case of an unusual pulmonary artery mass with PIK3CA mutation found in a post heart transplant patient. We were able to spare her the morbidity of a redo-sternotomy by excising the mass via a minimally invasive left anterior thoracotomy approach.

Anticoagulation Bridging in Patients With Left Ventricular Assist Device: A Regional Analysis of HeartMate 3 Recipients.

Advances in left ventricular assist device technologies have led to an improvement in pump hemocompatibility and outcomes. Because of concerns of thromboembolic complications in prior generations of left ventricular assist devices, bridging with parenteral anticoagulants was routinely. Management strategies of subtherapeutic INRs and their effects on the current generation of devices deserve review. We performed analysis of the MOMENTUM 3 trial including 6 centers in the mid-America region. Patients with subtherapeutic INRs (INR < 2) occurring after the index admission underwent chart review to determine the management strategies taken by clinicians. Strategies were divided into two groups, bridging or nonbridging. Of the 225 patients included in the analysis, 130 (58%) patients had a total of 235 subtherapeutic international normalized ratio (INR) events. Most (n = 179, 76.2%) of these INRs were not bridged (n = 100 warfarin dose adjustment, n = 79 no change in warfarin dose). Among those INRs (n = 56, 23.8%) treated with bridging, approximately half (n = 30, 53.6%) were treated with subcutaneous agents and other half (n = 26, 46.4%) were treated with intravenous agents. There was no difference in individual outcomes or composite endpoints of death, rehospitalization, CVA, or bleeding events between the groups.

Impact of Heart Transplant Allocation Change on Waitlist Mortality and Posttransplant Mortality in Patients With Left Ventricular Assist Devices.

BACKGROUND: In October 2018, the US heart transplant (HT) allocation system was revised giving patients with left ventricular assist device (LVAD) intermediate priority status. Few studies have examined the impact of this policy change on outcomes among patients with LVAD. We sought to determine how the allocation change impacted waitlist and posttransplant mortality in patients with LVAD. METHODS: We retrospectively assessed the United Network for Organ Sharing registry for patients with LVAD who were listed for or underwent HT between October 2016 and October 2021. We evaluated waitlist mortality using competing risks analysis and a multivariable Fine-Gray model, and posttransplant mortality using Kaplan-Meier survival analysis and a multivariate proportional hazards model. RESULTS: We analyzed data from 3835 patients with LVAD listed for HT and 3486 patients with LVAD who underwent HT during the study period. Listing for HT preallocation change was significantly associated with an increased risk of waitlist mortality (Gray P=0.0058) compared with postallocation change. After adjustment for covariates, mortality differences by listing era were attenuated, but LVAD brand was significantly associated with waitlist mortality (HM3 versus HMII; hazard ratio, 0.38 [95% CI, 0.21-0.69]; P=0.002; HVAD versus HMII; hazard ratio, 0.79 [95% CI, 0.48-1.30]; P=0.36; overall P=0.004). In contrast, HT postallocation change was associated with increased posttransplant mortality (log-rank P=0.0172) compared with preallocation change. In a multivariable analysis, the association with posttransplant mortality between transplant eras was attenuated, but ischemic time (hazard ratio, 1.16 [95% CI, 1.07-1.26]; P<0.001) and status at time of HT (Status 1-3 versus 4; hazard ratio, 1.29 [95% CI, 1.04-1.61]; P=0.02) were significantly associated with posttransplant mortality. CONCLUSIONS: Among patients with LVAD, lower waitlist mortality postallocation change was likely driven by improved LVAD technology. Higher posttransplant mortality following the allocation change was largely attributable to longer ischemic times and patient acuity.

Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT).

OBJECTIVES: The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy. METHODS: We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, -15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol. RESULTS: The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, -1.2%; Farrington Manning lower 1-sided 95% CI, -9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts. CONCLUSIONS: Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.

Age-Stratified Surgical Aortic Valve Replacement for Aortic Stenosis.

BACKGROUND: The management of aortic stenosis has evolved to stratification by age as reflected in recent societal guidelines. We evaluated age-stratified surgical aortic valve replacement (SAVR) trends and outcomes in patients with bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) from The Society of Thoracic Surgeons Adult Cardiac Surgery Database. METHODS: This cohort included adults (≥18 years) undergoing SAVR for severe aortic stenosis between July 2011 and December 2022. Comparisons were stratified by age (<65 years, 65-79 years, ≥80 years) and BAV or TAV status. Primary end points included operative mortality, composite morbidity and mortality, and permanent stroke. Observed to expected ratios by The Society of Thoracic Surgeons predicted risk of mortality were calculated. RESULTS: In total, 200,849 SAVR patients (55,326 BAV [27.5%], 145,526 TAV [72.5%]) from 1238 participating hospitals met study criteria. Annual SAVR volumes decreased by 45% (19,560 to 10,851) during the study period. The decrease was greatest (96%) for patients ≥80 years of age (4914 to 207). The relative prevalence of BAV was greater in younger patients (<65 years, 69,068 [49.5% BAV]; 65-79 years, 104,382 [19.1% BAV]; ≥80 years, 27,399 [4.5% BAV]). The observed mortality in <80-year-old BAV patients (<65 years, 1.08; 65-79 years, 1.21; ≥80 years, 3.68) was better than the expected mortality rate (<65 years, 1.22; 65-79 years, 1.54; ≥80 years, 3.14). CONCLUSIONS: SAVR volume in the transcatheter era has decreased substantially, particularly for patients ≥80 years old and for those with TAV. Younger patients with BAV have better than expected outcomes, which should be carefully considered during shared decision-making in the treatment of aortic stenosis. SAVR should remain the preferred therapy in this population.