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Donation after circulatory death heart transplantation using normothermic regional perfusion:The NYU Protocol

James, Les; LaSala, V. Reed; Hill, Fredrick; Ngai, Jennie Y.; Reyentovich, Alex; Hussain, Syed T.; Gidea, Claudia; Piper, Greta L.; Galloway, Aubrey C.; Smith, Deane E.; Moazami, Nader
Objective: This study aimed to evaluate the impact of cardiopulmonary bypass for thoraco-abdominal normothermic regional perfusion on the metabolic milieu of donation after cardiac death organ donors before transplantation. Methods: Local donation after cardiac death donor offers are assessed for suitability and willingness to participate. Withdrawal of life-sustaining therapy is performed in the operating room. After declaration of circulatory death and a 5-minute observation period, the cardiac team performs a median sternotomy, ligation of the aortic arch vessels, and initiation of thoraco-abdominal normothermic regional perfusion via central cardiopulmonary bypass at 37 °C. Three sodium chloride zero balance ultrafiltration bags containing 50 mEq sodium bicarbonate and 0.5 g calcium carbonate are infused. Arterial blood gas measurements are obtained every 15 minutes after every zero balance ultrafiltration bag is infused, and blood is transfused as needed to maintain hemoglobin greater than 8 mg/dL. Cardiopulmonary bypass is weaned with concurrent hemodynamic and transesophageal echocardiogram evaluation of the donor heart. The remainder of the procurement, including the abdominal organs, proceeds in a similar controlled fashion as is performed for a standard donation after brain death donor. Results: Between January 2020 and May 2022, 18 donation after cardiac death transplants using the thoraco-abdominal normothermic regional perfusion protocol were performed at our institution. The median donor age was 42.5 years (range, 20-51 years), and 88.9% (16/18) were male. The mean total donor cardiopulmonary bypass time was 88.8 ± 51.8 minutes. At the beginning of cardiopulmonary bypass, the average donor lactate was 9.4 ± 1.5 mmol/L compared with an average final lactate of 5.3 ± 2.7 mmol/L (P<.0001). The average beginning potassium was 6.5 ± 1.8 mmol/L compared with an average end potassium of 4.2 ± 0.4 mmol/L (P<.0001). The average beginning hemoglobin was 6.8 ± 0.7 g/dL, and the average end hemoglobin was 8.2 ± 1.3 g/dL (P<.001). On average, donation after cardiac death donors received transfusions of 2.3 ± 1.5 units of packed red blood cells. Of the 18 donors who underwent normothermic regional perfusion, all hearts were deemed suitable for recovery and successfully transplanted, a yield of 100%. Other organs successfully recovered and transplanted include kidneys (80.6% yield), livers (66.7% yield), and bilateral lungs (27.8% yield). Conclusions: The use of cardiopulmonary bypass for thoraco-abdominal normothermic regional perfusion is a burgeoning option for improving the quality of organs from donation after cardiac death donors. Meticulous intraoperative management of donation after cardiac death donors with a specific focus on improving their metabolic milieu may lead to improved graft function in transplant recipients.
ISSN: 2666-2507
CID: 5408422

Long-term follow-up of acute and chronic rejection in heart transplant recipients from hepatitis C viremic (NAT+) donors

Stachel, Maxine W; Alimi, Marjan; Narula, Navneet; Flattery, Erin E; Xia, Yuhe; Ramachandran, Abhinay; Saraon, Tajinderpal; Smith, Deane; Reyentovich, Alex; Goldberg, Randal; Kadosh, Bernard S; Razzouk, Louai; Katz, Stuart; Moazami, Nader; Gidea, Claudia G
The long-term safety of heart transplants from hepatitis C viremic (NAT+) donors remains uncertain. We conducted a prospective study of all patients who underwent heart transplantation at our center from January 2018 through August 2020. Routine testing was performed to assess for donor-derived cell-free DNA, acute cellular rejection (ACR), antibody-mediated rejection (AMR), and cardiac allograft vasculopathy (CAV). Allograft dysfunction and mortality were also monitored. Seventy-five NAT- recipients and 32 NAT+ recipients were enrolled in the study. All NAT+ recipients developed viremia detected by PCR, were treated with glecaprevir/pibrentasvir at the time of viremia detection, and cleared the virus by 59 days post-transplant. Patients who underwent NAT testing starting on post-operative day 7 (NAT+ Group 1) had significantly higher viral loads and were viremic for a longer period compared with patients tested on post-operative day 1 (NAT+ Group 2). Through 3.5 years of follow-up, there were no statistically significant differences in timing, severity, or frequency of ACR in NAT+ recipients compared with the NAT- cohort, nor were there differences in noninvasive measures of graft injury, incidence or severity of CAV, graft dysfunction, or mortality. There were five episodes of AMR, all in the NAT- group. There were no statistically significant differences between Group 1 and Group 2 NAT+ cohorts. Overall, these findings underscore the safety of heart transplantation from NAT+ donors.
PMID: 36053676
ISSN: 1600-6143
CID: 5332222

Position Statement on Vascular Access Safety for Percutaneous Devices in AMI Complicated by Cardiogenic Shock

Damluji, Abdulla A; Tehrani, Behnam; Sinha, Shashank S; Samsky, Marc D; Henry, Timothy D; Thiele, Holger; West, Nick E J; Senatore, Fortunato F; Truesdell, Alexander G; Dangas, George D; Smilowitz, Nathaniel R; Amin, Amit P; deVore, Adam D; Moazami, Nader; Cigarroa, Joaquin E; Rao, Sunil V; Krucoff, Mitchell W; Morrow, David A; Gilchrist, Ian C
In the United States, the frequency of using percutaneous mechanical circulatory support devices for acute myocardial infarction complicated by cardiogenic shock is increasing. These devices require large-bore vascular access to provide left, right, or biventricular cardiac support, frequently under urgent/emergent circumstances. Significant technical and logistical variability exists in device insertion, care, and removal in the cardiac catheterization laboratory and in the cardiac intensive care unit. This variability in practice may contribute to adverse outcomes observed in centers that receive patients with cardiogenic shock, who are at higher risk for circulatory insufficiency, venous stasis, bleeding, and arterial hypoperfusion. In this position statement, we aim to: 1) describe the public health impact of bleeding and vascular complications in cardiogenic shock; 2) highlight knowledge gaps for vascular safety and provide a roadmap for a regulatory perspective necessary for advancing the field; 3) propose a minimum core set of process elements, or "vascular safety bundle"; and 4) develop a possible study design for a pragmatic trial platform to evaluate which structured approach to vascular access drives most benefit and prevents vascular and bleeding complications in practice.
PMID: 36265932
ISSN: 1876-7605
CID: 5352542

Efficacy of Proning in Acute Respiratory Distress Syndrome on Extracorporeal Membrane Oxygenation

Chang, Stephanie H; Smith, Deane E; Carillo, Julius A; Sommer, Philip M; Geraci, Travis C; Williams, David; Paone, Darien; Goldernberg, Ronald; Chan, Justin; Kon, Zachary N; Galloway, Aubrey C; Moazami, Nader
Objectives/UNASSIGNED:Proning patients with acute respiratory distress syndrome (ARDS) has been associated with increased survival, though little data exists evaluating the safety and feasibility of proning ARDS patients on extracorporeal membrane oxygenation (ECMO). Methods/UNASSIGNED:, 2020 was performed. All proning events were evaluated for complications, as well as change in compliance, sweep, oxygenation and flow. The primary outcome of this study was the rate major morbidity associated with proning while on ECMO. Results/UNASSIGNED:of 86 pre to 103 post (p<0.0001). Mean ECMO flow was unchanged. Conclusions/UNASSIGNED:Proning in patients with ARDS on ECMO is safe with an associated improvement in lung mechanics. With careful planning and coordination, these data support the practice of appropriately proning patients with severe ARDS, even if they are on ECMO.
PMID: 36168330
ISSN: 2666-2507
CID: 5334262

Tocilizumab Accelerates Recovery in Patients With Severe COVID-19 Pneumonia on Venovenous Extracorporeal Membrane Oxygenation

Lewis, Tyler C; Arnouk, Serena; Toy, Bridget; Geraci, Travis C; Carillo, Julius A; Chang, Stephanie H; Moazami, Nader; Kon, Zachary N; Smith, Deane E
PMID: 35483095
ISSN: 1538-943x
CID: 5217622

Early experience with donation after circulatory death heart transplantation using normothermic regional perfusion in the United States

Smith, Deane E; Kon, Zachary N; Carillo, Julius A; Chen, Stacey; Gidea, Claudia G; Piper, Greta L; Reyentovich, Alex; Montgomery, Robert A; Galloway, Aubrey C; Moazami, Nader
OBJECTIVE:This pilot study sought to evaluate the feasibility of our donation after circulatory death (DCD) heart transplantation protocol using cardiopulmonary bypass (CPB) for normothermic regional reperfusion (NRP). METHODS:Suitable local DCD candidates were transferred to our institution. Life support was withdrawn in the operating room (OR). On declaration of circulatory death, sternotomy was performed, and the aortic arch vessels were ligated. CPB was initiated with left ventricular venting. The heart was reperfused, with correction of any metabolic abnormalities. CPB was weaned, and cardiac function was assessed at 30-minute intervals. If accepted, the heart was procured with cold preservation and transplanted into recipients in a nearby OR. RESULTS:Between January 2020 and January 2021, a total of 8 DCD heart transplants were performed: 6 isolated hearts, 1 heart-lung, and 1 combined heart and kidney. All donor hearts were successfully resuscitated and weaned from CPB without inotropic support. Average lactate and potassium levels decreased from 9.39 ± 1.47 mmol/L to 7.20 ± 0.13 mmol/L and 7.49 ± 1.32 mmol/L to 4.36 ± 0.67 mmol/L, respectively. Post-transplantation, the heart-lung transplant recipient required venoarterial extracorporeal membrane oxygenation for primary lung graft dysfunction but was decannulated on postoperative day 3 and recovered uneventfully. All other recipients required minimal inotropic support without mechanical circulatory support. Survival was 100% with a median follow-up of 304 days (interquartile range, 105-371 days). CONCLUSIONS:DCD heart transplantation outcomes have been excellent. Our DCD protocol is adoptable for more widespread use and will increase donor heart availability in the United States.
PMID: 34728084
ISSN: 1097-685x
CID: 5038042

COUNTERPOINT: Does Normothermic Regional Perfusion Violate the Ethical Principles Underlying Organ Procurement? No [Editorial]

James, Les; Parent, Brendan; Moazami, Nader; Smith, Deane E
PMID: 35940652
ISSN: 1931-3543
CID: 5286662

Rebuttal From Dr James et al [Editorial]

James, Les; Parent, Brendan; Moazami, Nader; Smith, Deane E
PMID: 35940654
ISSN: 1931-3543
CID: 5286672

One-Year Outcomes With Venovenous Extracorporeal Membrane Oxygenation Support for Severe COVID-19

Smith, Deane E; Chang, Stephanie H; Geraci, Travis C; James, Les; Kon, Zachary N; Carillo, Julius A; Alimi, Marjan; Williams, David; Scheinerman, Joshua A; Cerfolio, Robert J; Grossi, Eugene A; Moazami, Nader; Galloway, Aubrey C
BACKGROUND:Severe coronavirus disease 2019 (COVID-19) can cause acute respiratory failure requiring mechanical ventilation. Venovenous (VV) extracorporeal membrane oxygenation (ECMO) has been used in patients in whom conventional mechanical ventilatory support has failed. To date, published data have focused on survival from ECMO and survival to discharge. In addition to survival to discharge, this study reports 1-year follow-up data for patients who were successfully discharged from the hospital. METHODS:A single-institution, retrospective review of all patients with severe COVID-19 who were cannulated for VV-ECMO between March 10, 2020 and May 1, 2020 was performed. A multidisciplinary ECMO team evaluated, selected, and managed patients with ECMO support. The primary outcome of this study was survival to discharge. Available 1-year follow-up data are also reported. RESULTS:A total of 30 patients were supported with VV-ECMO, and 27 patients (90%) survived to discharge. All patients were discharged home or to acute rehabilitation on room air, except for 1 patient (3.7%), who required supplemental oxygen therapy. At a median follow-up of 10.8 months (interquartile range [IQR], 8.9-14.4 months) since ECMO cannulation, survival was 86.7%, including 1 patient who underwent lung transplantation. Of the patients discharged from the hospital, 44.4% (12/27) had pulmonary function testing, with a median percent predicted forced expiratory volume of 100% (IQR, 91%-110%). For survivors, a 6-minute walk test was performed in 59.3% (16/27), with a median value of 350 m (IQR, 286-379 m). CONCLUSIONS:A well-defined patient selection and management strategy of VV-ECMO support in patients with severe COVID-19 resulted in exceptional survival to discharge that was sustained at 1-year after ECMO cannulation.
PMID: 35282865
ISSN: 1552-6259
CID: 5183722

Commentary: Normothermic regional perfusion: Ethical issues in thoracic organ donation: An important discussion, but stop the press! [Editorial]

Smith, Deane; Moazami, Nader
PMID: 35317916
ISSN: 1097-685x
CID: 5206662