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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 Life support was withdrawn in the operating room (OR).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

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.
PMCID:8907014
PMID: 35282865
ISSN: 1552-6259
CID: 5183722

COVID-19-Associated Large- and Medium-Sized-Vessel Pathology: A Case Series

Chen, Stacey; Malas, Jad; Latson, Larry A; Narula, Navneet; Rapkiewicz, Amy V; Williams, David M; Pass, Harvey I; Galloway, Aubrey C; Smith, Deane E
BACKGROUND: Coronavirus disease-19 (COVID-19) remains a public health crisis. The epidemiology of COVID-19-associated large- and medium-sized-vessel pathology is not well characterized. The aim of this study is to identify patients with possible COVID-19-associated large- and medium-sized-vessel pathology based on computed tomography (CT) imaging to provide insight into this rare, but potentially devastating, cardiovascular manifestation. METHODS: This is a single-center retrospective review of patients with CT chest, abdomen, and/or pelvis concerning for large- and medium-vessel pathology and confirmed COVID-19 infection from March 1, 2020 to October 31, 2020. RESULTS: During the study period, 6,553 CT reports were reviewed and pertinent imaging was identified in 139 patients. Of these, 8 patients (median age: 59 years, range 51-82) were COVID-19 positive. All patients had preexisting cardiovascular risk factors and three (37.5%) had an autoimmune disease. Four patients were never hospitalized for COVID-19. Among these, two presented to the hospital at a median of 39 days (range: 27-50) after their initial COVID-19 test with chest and back pain where imaging revealed extensive aortic pathology. One patient required surgical management for aortic pathology. All other patients were treated with expectant management and outpatient follow-up. CONCLUSION/CONCLUSIONS: The clinical and radiological presentations of COVID-19-associated large- and medium-vessel pathology are heterogeneous and can be a late finding after COVID-19 recovery. Close clinical follow-up and surveillance imaging for large- and medium-sized-vessel pathology may be warranted in COVID-19 patients.
PMCID:9626037
PMID: 36318931
ISSN: 2325-4637
CID: 5358562

Logistics for expanding heart transplantation from donation after circulatory death using normothermic regional perfusion [Editorial]

Moazami, Nader; Smith, Deane; Galloway, Aubrey
PMCID:8987364
PMID: 35403040
ISSN: 2666-2507
CID: 5191102

Prior Infrarenal Aortic Surgery is Not Associated with Increased Risk of Spinal Cord Ischemia Following Thoracic Endovascular Aortic Repair and Complex Endovascular Aortic Repair

Chen, Stacey; Rokosh, Rae S; Smith, Deane E; Maldonado, Thomas S; Cayne, Neal S; Jacobowitz, Glenn R; Rockman, Caron B; Patel, Virendra I; Veith, Frank J; Galloway, Aubrey C; Garg, Karan
OBJECTIVES/OBJECTIVE:Patients with prior infrarenal aortic intervention represent an increasing demographic of patients undergoing thoracic endovascular aortic repair (TEVAR) and/or complex EVAR. Studies have suggested that prior abdominal aortic surgery is a risk factor for spinal cord ischemia (SCI). However, these results are largely based on single-center experiences with limited multi-institutional and national data assessing clinical outcomes in these patients. The objective of this study was to evaluate the effect of prior infrarenal aortic surgery on SCI. METHODS:The Society for Vascular Surgery Vascular Quality Initiative database was retrospectively reviewed to identify all patients ≥18 years old undergoing TEVAR/complex EVAR from January 2012 to June 2020. Patients with previous thoracic or suprarenal aortic repairs were excluded. Baseline and procedural characteristics and postoperative outcomes were compared by group: TEVAR/complex EVAR with or without previous infrarenal aortic repair. The primary outcome was postoperative SCI. Secondary outcomes included postoperative hospital length of stay (LOS), bowel ischemia, renal ischemia, and 30-day mortality. Multivariate regression was used to determine independent predictors of postoperative SCI. Additional analysis was performed for patients undergoing isolated TEVAR. RESULTS:A total of 9506 patients met the inclusion criteria: 8691 (91.4%) had no history of infrarenal aortic repair and 815 (8.6%) had previous infrarenal aortic repair. Patients with previous infrarenal repair were older with an increased prevalence of chronic kidney disease (p=0.001) and cardiovascular risk factors including hypertension, chronic obstructive pulmonary disease, and smoking history (p<0.001). These patients presented with larger maximal aortic diameters (6.06±1.47 cm versus 5.15±1.76 cm; p<0.001) and required more stent grafts (p<0.001) with increased intraoperative blood transfusion requirements (p<0.001), and longer procedure times (p<0.001). Univariate analysis demonstrated no difference in postoperative SCI, postoperative hospital LOS, bowel ischemia, or renal ischemia between the two groups. Thirty-day mortality was significantly higher in patients with prior infrarenal repair (p=0.001). On multivariate regression, prior infrarenal aortic repair was not a predictor of postoperative SCI, while aortic dissection (odds ratio [OR] 1.65; 95% confidence interval [CI] 1.26-2.16, p<0.001), number of stent grafts deployed (OR 1.45; 95% CI 1.30-1.62, p<0.001), and units of packed red blood cells transfused intraoperatively (OR 1.33; 95% CI 1.03-1.73, p=0.032) were independent predictors of SCI. CONCLUSIONS:Although TEVAR/complex EVAR patients with prior infrarenal aortic repair constituted a sicker cohort with higher 30-day mortality, the rate of SCI was comparable to patients without prior repair. Previous infrarenal repair was not associated with risk of SCI.
PMID: 34742886
ISSN: 1097-6809
CID: 5050112

Primary Graft Dysfunction After Heart Transplantation: Incidence and Current Risk Factors [Meeting Abstract]

Chen, S.; Ostberg, N. P.; Carillo, J. A.; Gidea, C.; Reyentovich, A.; Galloway, A. C.; Moazami, N.; Smith, D. E.
ISI:000780119701158
ISSN: 1053-2498
CID: 5243552

Semirigid posterior annuloplasty band: Reshaping the mitral orifice while preserving its physiology [Editorial]

James, Les; Grossi, Eugene A; Loulmet, Didier F; Galloway, Aubrey C
PMID: 34977703
ISSN: 2666-2507
CID: 5106842

Hemoadsorption for management of patients on veno-venous ECMO support for severe COVID-19 acute respiratory distress syndrome

Geraci, Travis C; Kon, Zachary N; Moazami, Nader; Chang, Stephanie H; Carillo, Julius; Chen, Stacey; Fargnoli, Anthony; Alimi, Marjan; Pass, Harvey; Galloway, Aubrey; Smith, Deane E
BACKGROUND AND AIM/OBJECTIVE:Patients with severe coronavirus disease 2019 (COVID-19) develop a profound cytokine-mediated pro-inflammatory response. This study reports outcomes in 10 patients with COVID-19 supported on veno-venous extracorporeal membrane oxygenation (VV-ECMO) who were selected for the emergency use of a hemoadsorption column integrated in the ECMO circuit. MATERIALS AND METHODS/METHODS:Pre and posttreatment, clinical data, and inflammatory markers were assessed to determine the safety and feasibility of using this system and to evaluate the clinical effect. RESULTS:During hemoadsorption, median levels of interleukin (IL)-2R, IL-6, and IL-10 decreased by 54%, 86%, and 64%, respectively. Reductions in other markers were observed for lactate dehydrogenase (-49%), ferritin (-46%), d-dimer (-7%), C-reactive protein (-55%), procalcitonin (-76%), and lactate (-44%). Vasoactive-inotrope scores decreased significantly over the treatment interval (-80%). The median hospital length of stay was 53 days (36-85) and at 90-days post cannulation, survival was 90% which was similar to a group of patients without the use of hemoadsorption. CONCLUSIONS:Addition of hemoadsorption to VV-ECMO in patients with severe COVID-19 is feasible and reduces measured cytokine levels. However, in this small series, the precise impact on the overall clinical course and survival benefit still remains unknown.
PMID: 34219277
ISSN: 1540-8191
CID: 4932852

Impact of CytoSorb Hemoadsorption on Sedation Requirements in Patients With Severe COVID-19 on Venovenous Extracorporeal Membrane Oxygenation

Lewis, Tyler C; Merchan, Cristian; Toy, Bridget; Goldenberg, Ronald M; Geraci, Travis C; Chang, Stephanie H; Galloway, Aubrey C; Smith, Deane E; Moazami, Nader
Hemoadsorption with CytoSorb has been used as an adjunct in the treatment of severe coronavirus disease 2019 (COVID-19)-related respiratory failure. It remains unknown if CytoSorb hemoadsorption will alter sedative and analgesic dosing in critically ill patients on venovenous extracorporeal membrane oxygenation (VV-ECMO). We conducted a retrospective review of patients with severe COVID-19 requiring VV-ECMO for respiratory support. Patients who were enrolled in a clinical study of CytoSorb were compared with patients on VV-ECMO alone. Data were collected for the 72-hour CytoSorb therapy and an additional 72 hours post-CytoSorb, or a corresponding control time period. Sedative and analgesic doses were totaled for each day and converted to midazolam or fentanyl equivalents, respectively. The primary endpoint, change in sedative and analgesic requirements over time, were compared using a two-way mixed analysis of variance. Of the 30 patients cannulated for VV-ECMO for COVID-19, 4 were excluded, leaving 8 patients in the CytoSorb arm and 18 in the Control. There was no effect of CytoSorb therapy on midazolam equivalents over the 72-hour therapy (p = 0.71) or the 72 hours post-CytoSorb (p = 0.11). In contrast, there was a significant effect of CytoSorb therapy on fentanyl equivalents over the first 72 hours (p = 0.01), but this was not consistent over the 72-hours post-CytoSorb (p = 0.23). CytoSorb therapy led to significant increases in analgesic requirements without impacting sedative requirements. Further research is needed to define the relevance of CytoSorb hemoadsorption on critical care pharmacotherapy.
PMID: 34339400
ISSN: 1538-943x
CID: 4988552

Impact of Early Initiation of Direct-Acting Antiviral Therapy in Thoracic Organ Transplantation from Hepatitis C Virus Positive Donors

Smith, Deane E; Chen, Stacey; Fargnoli, Anthony; Lewis, Tyler; Galloway, Aubrey C; Kon, Zachary N; Moazami, Nader
Thoracic organs from Hepatitis C virus (HCV) positive donors are not commonly used for transplantation. The development of direct-acting antivirals (DAA) for HCV treatment has led to renewed interest in using HCV-positive organs. We evaluated HCV transmission rates, viremia clearance, and short-term outcomes in HCV-negative patients who received HCV-positive thoracic organs at our institution. From January 1, 2018 to May 31, 2019, 38 patients underwent HCV-positive thoracic organ transplantation (16 lungs and 22 hearts). Heart recipients were started on glecaprevir/pibrentasvir, a pangenotypic DAA, when they developed HCV viremia. Lung recipients were empirically started on glecaprevir/pibrentasvir within the first three post-transplant days. The primary outcome was cure of HCV defined as sustained virologic response at 12 weeks (SVR12). All heart recipients developed HCV viremia with median initial viral load of 64,565 IU/mL (interquartile range: 1660 to 473,151). The median time from DAA initiation to viremia clearance was 19 days (confidence interval: 15-27 days). 11 out of 16 (68.8%) lung recipients developed HCV viremia with median initial viral load of 26 IU/mL (interquartile range: 15 to 143). The median time from DAA initiation to viremia clearance was 10 days (confidence interval: 6-17 days). 5 out of 16 (31.3%) lung recipients never became viremic. All patients demonstrated SVR12. Thoracic organ transplantation from HCV viremic donors is safe with excellent short-term survival. Early initiation of HCV treatment results in rapid viremia clearance and SVR12. Long-term outcomes and optimal timing of DAA initiation remains to be determined.
PMID: 32621962
ISSN: 1532-9488
CID: 4518072