Consensus Statement: Technical Standards for Thoracoabdominal Normothermic Regional Perfusion.

BACKGROUND: Thoracoabdominal normothermic regional perfusion (TA-NRP) has emerged as a powerful technique for optimizing organ procurement from donation after circulatory death donors. Despite its rapid adoption, standardized guidelines for TA-NRP implementation are lacking, prompting the need for consensus recommendations to ensure safe and effective utilization of this technique. METHODS: A working group composed of members from The American Society of Transplant Surgeons, The International Society of Heart and Lung Transplantation, The Society of Thoracic Surgeons, and The American Association for Thoracic Surgery was convened to develop technical guidelines for TA-NRP. The group systematically reviewed existing literature, consensus statements, and expert opinions to identify key areas requiring standardization, including predonation evaluation, intraoperative management, postdonation procedures, and future research directions. RESULTS: The working group formulated recommendations encompassing donor evaluation and selection criteria, premortem testing and therapeutic interventions, communication protocols, and procedural guidelines for TA-NRP implementation. These recommendations aim to facilitate coordination among transplant teams, minimize variability in practice, and promote transparency and accountability throughout the TA-NRP process. CONCLUSIONS: The consensus guidelines presented herein serve as a comprehensive framework for the successful and ethical implementation of TA-NRP programs in organ procurement from donation after circulatory death donors. By providing standardized recommendations and addressing areas of uncertainty, these guidelines aim to enhance the quality, safety, and efficiency of TA-NRP procedures, ultimately contributing to improved outcomes for transplant recipients.

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.

A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.

BACKGROUND: In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS: We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS: This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS: Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

Prospective Assessment of Frailty Using the Fried Criteria in Patients Undergoing Left Ventricular Assist Device Therapy.

Frail patients are more prone to adverse events after cardiac surgery, particularly after implantation of left ventricular assist devices. Thus, frailty assessment may help identify patients unlikely to benefit from left ventricular assist device therapy. The purpose was to establish a suitable measure of frailty in adults with end-stage heart failure. In a prospective cohort of 75 patients (age 58 ± 12 years) with end-stage heart failure, we assessed the association between frailty (5-component Fried criteria) and the composite primary outcome of inpatient mortality or prolonged length of stay, as well as extubation status, time on ventilator, discharge status, and long-term mortality. Fried frailty criteria were met in 44 (59%) patients, but there was no association with the primary outcome (p = 0.10). However, an abridged set of 3 criteria (exhaustion, inactivity, and grip strength) was predictive of the primary outcome (odds ratio 2.9, 95% confidence interval 1.1 to 7.4), and of time to extubation and time to discharge. In patients with advanced heart failure, the 5-component Fried criteria may not be optimally sensitive to clinical differences. In conclusion, an abridged set of 3 frailty criteria was predictive of the primary outcome and several secondary outcomes, and may therefore be a clinically useful tool in this population.

Left Ventricular Assist Device Inflow Angle and Pump Positional Change Over Time Adverse Impact on Left Ventricular Assist Device Function.

BACKGROUND: This study investigates the impact of left ventricular assist device (LVAD) inflow cannula angulation, pump positional change over time, and the incidence of thrombotic pump dysfunction in a large cohort of HeartMate II (HM2) patients. METHODS: Patients (n = 326) who received primary HM2 LVAD between January 2008 and December 2013 at a single institution were retrospectively reviewed. Patients who underwent pump exchange (PE) for pump dysfunction, patients who had pump dysfunction (PD) but did not require pump exchange, and patients with normal LVAD pump dysfunction (NL) were compared. Pump positional change and angle of the inflow cannula with respect to the angle between inflow cannula and the LVAD body (IL angle) were measured from routine chest radiograph at postoperation, before discharge, and follow-up. Pump positional change was assessed based on pump positional differences between discharge and follow-up. Patients were also grouped by IL acute angulation (less than 65 degrees) and pump positional change. RESULTS: There were 21, 15, and 290 patients in the PE group, PD group, and NL group, respectively. There were significant differences in IL angle between PE and NL at all timepoints: postoperation (PD 63.6 ± 12.5, NL 70.6 ± 12.3; p = 0.018), before discharge (PD 64.4 ± 12.8, NL 69.5 ± 10.5; p = 0.039), and follow-up (PD 62.6 ± 14.2, NL 67.9 ± 11.2; p = 0.002). However, the IL angle was insignificant between PE and PD groups and between PD and NL groups. Sixty-seven percent of the PE group had pump positional change as opposed to 36% of the NL group (p = 0.019). Eighty-four of 101 patients with pump positional change and 75 of 91 patients with acute angulation at postoperation did not have pump dysfunction. CONCLUSIONS: Pump positional change may contribute to LVAD dysfunction or failure, but it does not entirely account for observed pump dysfunction or failure.

Outcomes in Patients Bridged With Univentricular and Biventricular Devices in the Modern Era of Heart Transplantation.

BACKGROUND: Biventricular support before orthotopic heart transplantation (OHT) has been shown to adversely affect short- and long-term outcomes, but the comparative effect of support type is largely unknown. This study determined the comparative effect of univentricular and biventricular support on survival in bridged patients after OHT. METHODS: The United Network of Organ Sharing database was queried for adult patients bridged to OHT with a univentricular (left ventricular assist device [LVAD]), biventricular (biventricular assist device [BiVAD]), or total artificial heart ([TAH]) device between 2004 and 2012. Unconditional and conditional survivals were compared with the Kaplan-Meier method. Cox proportional hazards regression models were constructed to determine the risk-adjusted influence of support type on death. RESULTS: Of the 4,177 patients identified, 3,457 (20.4%), 575 (3.4%), and 145 (0.9%) were bridged with an LVAD, BiVAD, and TAH, respectively. Unadjusted 30-day, 1-year, and 5-year estimated survival was greater in LVAD patients than in the BiVAD and TAH cohorts. After risk-adjustment, BiVAD and TAH were associated with an increased risk of death at all time points. Unadjusted and adjusted 5-year survival, conditional on 1-year survival, was worse, however, in only TAH patients. CONCLUSIONS: Patients with biventricular failure bridged to OHT with a TAH or BiVAD experience worse short- and long-term survival comparison with those with an LVAD. This difference is most likely due to an increase in early death and depends on the type of BiVAD device implanted.

Right ventricular assist device with membrane oxygenator support for right ventricular failure following implantable left ventricular assist device placement.

OBJECTIVES: Cardiogenic shock from refractory right ventricular (RV) failure during left ventricular assist device placement is associated with high morbidity and mortality. The addition of extracorporeal membrane oxygenation to RV mechanical assistance may help RV recovery and lead to improved outcomes. METHODS: We retrospectively reviewed all implanted continuous-flow left ventricular assist devices from April 2009 to June 2013. RV mechanical support was utilized for RV failure defined as haemodynamic instability despite vasopressors, pulmonary vascular dilators and inotropic therapy. RV assist devices were utilized with and without in-line membrane oxygenation. RESULTS: During the study period, 267 continuous-flow left ventricular assist devices were implanted. RV mechanical support was utilized in 27 (10%) patients; 12 (46%) had the addition of in-line extracorporeal membrane oxygenation. The mean age of patients with a right ventricular assist device with membrane oxygenation was lower than that in patients with a right ventricular assist device alone (45.6 ± 15.9 vs 64.6 ± 6.5, P = 0.001). Support was weaned in 66% (10 of 15) of patients with right ventricular assist device (RVAD) alone vs 83% (10 of 12) of those with RVAD with membrane oxygenation (P = 0.42). The RVAD was removed after 10.4 ± 9.4 vs 5 ± 2.99 days for patients with a RVAD with membrane oxygenation (P = 0.1). Patients with RVAD with membrane oxygenation had a 30-day mortality rate of 8 vs 47% for those with RVAD alone (P = 0.04). The survival rate after discharge was 86, 63 and 54% at 3, 6 and 12 months for both groups combined. CONCLUSIONS: Patients with a RVAD with membrane oxygenation support for acute RV failure after continuous-flow left ventricular assist device implantation had a lower 30-day mortality than those with a RVAD alone. Patients who survive to discharge have a reasonable 1-year survival. Combining membrane oxygenation with RVAD support appears to offer a short-term survival benefit in patients with RV failure after continuous-flow left ventricular assist device implantation.

Racial and Ethnic Differences in Lung Cancer Surgical Stage: An STS Database Study.

BACKGROUND: Racial and ethnic differences in lung cancer care have been previously documented. These differences may be related to access to care, cultural differences, or fewer patients presenting with operable lung cancer. The relationship between race and pathologic stage of patients who undergo lung cancer resection has not been defined. This study estimates racial disparities in lung cancer stage among patients who undergo surgical resection. METHODS: The Society of Thoracic Surgeons (STS) database was queried for patients who underwent resection of non-small cell lung cancer and had complete pathologic staging and racial identification. Univariate and multivariate analyses were performed. Study end point was the pathologic stage and we evaluated its association with the racial and ethnic origins of the patients. RESULTS: Of 19,173 eligible patients with non-small cell lung cancer of known pathological stage who underwent surgery between 2002 and 2008, the majority were Caucasian (17,148, 89.4%), 1,502 (7.8%) were African-American, 273 (1.4%) were Asian, and 250 (1.3%) were Hispanic. In univariate analysis, significantly more Caucasian and African-American patients underwent resection of stage I/II lung cancer (13,929, 81.2% and 1,217, 81%, respectively) as compared with the Asian (207, 75.2%) and Hispanic (188, 75.8%) patients (p = 0.007). Stage at operation did not differ between Caucasians and African-Americans. Multivariate analysis confirmed these findings (p = 0.03) after adjustment for age, gender, tobacco use, diabetes, and year of surgery. CONCLUSION: Within the STS database, patients identified as Asian or Hispanic had a significantly higher pathologic stage at the time of resection than Caucasian or African-American patients. The causes of these differences in the treatment of potentially curable lung cancer are unknown and require further investigation.