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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

Commentary: The future is now-heart donation after circulatory death [Editorial]

Kon, Zachary N; Smith, Deane E; Carillo, Julius A; Moazami, Nader
PMID: 32448684
ISSN: 1097-685x
CID: 4451462

Extracorporeal Membrane Oxygenation Support in Severe COVID-19

Kon, Zachary N; Smith, Deane E; Chang, Stephanie H; Goldenberg, Ronald M; Angel, Luis F; Carillo, Julius A; Geraci, Travis C; Cerfolio, Robert J; Montgomery, Robert A; Moazami, Nader; Galloway, Aubrey C
BACKGROUND:Coronavirus disease 2019 (Covid-19) remains a worldwide pandemic with a high mortality rate among patients requiring mechanical ventilation. The limited data that exists regarding the utility of extracorporeal membrane oxygenation (ECMO) in these critically ill patients shows poor overall outcomes. This paper describes our institutional practice regarding the application and management of ECMO support for patients with Covid-19 and reports promising early outcomes. METHODS:>60 mmHg with no life-limiting comorbidities. Patients were cannulated at bedside and were managed with protective lung ventilation, early tracheostomy, bronchoscopies and proning as clinically indicated. RESULTS:Of 321 patients intubated for Covid-19, 77 (24%) patients were evaluated for ECMO support with 27 (8.4%) patients placed on ECMO. All patients were placed on veno-venous ECMO. Current survival is 96.3%, with only one mortality to date in over 350 days of total ECMO support. Thirteen patients (48.1%) remain on ECMO support, while 13 patients (48.1%) have been successfully decannulated. Seven patients (25.9%) have been discharged from the hospital. Six patients (22.2%) remain in the hospital of which four are on room-air. No healthcare workers that participated in ECMO cannulation developed symptoms of or tested positive for Covid-19. CONCLUSIONS:The early outcomes presented here suggest that the judicious use of ECMO support in severe Covid-19 may be clinically beneficial.
PMID: 32687823
ISSN: 1552-6259
CID: 4531922

A Simple Prioritization Change to Lung Transplant Allocation May Result in Improved Outcomes

Chang, Stephanie H; Angel, Luis; Smith, Deane E; Carillo, Julius; Rudym, Darya; Lesko, Melissa; Sureau, Kimberly; Montgomery, Robert A; Moazami, Nader; Kon, Zachary N
BACKGROUND:The Lung Allocation Score (LAS) significantly improved outcomes and waitlist mortality in lung transplantation. However, mortality remains high for the sickest waitlist candidates despite additional changes to allocation distance. Regulatory considerations of overhauling the current lung allocation system has met significant resistance, and would require years to implement. This study evaluates if a modest change to the current system by prioritization of only high-LAS lung transplant candidates would result in lowered waitlist mortality. METHODS:The Thoracic Simulated Allocation Model was used to evaluate all lung transplant candidates and donor lungs recovered between July 1, 2009 and June 30, 2011. Current lung allocation rules (initial offer within 250 nautical-mile radius for ABO-identical then compatible offers) were run. Allocation was then changed for only patients with an LAS≥50 (high-LAS) to be prioritized within a 500 nautical-mile radius with no stratification between ABO-identical and compatible offers. Ten iterations of each model were run. Primary endpoints were waitlist mortality and post-transplant 1-year survival. RESULTS:6,538 waitlist candidates and transplant recipients were evaluated per iteration, for a total of 130,760 simulated patients. Compared with current allocation, the adjusted model had a 23.3% decrease in waitlist mortality. Post-transplant 1-year survival was minimally affected. CONCLUSIONS:Without overhauling the entire system, simple prioritization changes to the allocation system for high-LAS candidates may lead to decreased waitlist mortality and increased organ utilization. Importantly, these changes do not appear to lead to clinically significant changes in post-transplant 1-year survival.
PMID: 32687830
ISSN: 1552-6259
CID: 4531942

Comparison of device-specific adverse event profiles between Impella platforms

Chen, Stacey; Paone, Darien; Spellman, Lilly; Ranganath, Neel K; Carillo, Julius A; Gidea, Claudia G; Reyentovich, Alex; Thompson, Craig A; Razzouk, Louai; Kon, Zachary N; Moazami, Nader; Smith, Deane E
BACKGROUND:The Impella (Abiomed) ventricular support system is a family of temporary mechanical circulatory support (MCS) devices used to treat patients with cardiogenic shock, acute cardiogenic decompensation, and for high-risk percutaneous or surgical revascularization. These devices include the percutaneously implanted 2.5/cardiac power (CP) and the surgically implanted 5.0/left direct (LD). Despite the beneficial effects and increased usage of these devices, data to assess adverse outcomes and guide clinician decision-making between the Impella CP and 5.0/LD are limited. METHODS:This is a retrospective analysis of 91 consecutive patients who required at least 24 h of Impella support, from January 1, 2015 to December 31, 2019. Groups were stratified based on either initial Impella CP or 5.0/LD placement. Clinical outcomes and in-hospital complications were compared. RESULTS:Impella CP was implanted in 66 patients (mean age: 61 ± 15 years, male 71.2%) and Impella 5.0/LD was implanted in 25 patients (mean age: 62 ± 9 years, male 84.0%). There was greater stability of device position (p = .033), less incidence of hemolysis (p < .001), and less frequent need for additional MCS (p = .001) in patients implanted with the Impella 5.0/LD compared with Impella CP in this study cohort. Patients with Impella 5.0/LD were more likely to survive from Impella and survive to discharge. CONCLUSIONS:This study suggests that for patients who require temporary MCS for more than 24 h, the Impella 5.0/LD may have a more favorable device-specific adverse profile compared with the Impella CP.
PMID: 32939839
ISSN: 1540-8191
CID: 4593232

Ethical and Logistical Concerns for Establishing NRP-cDCD Heart Transplantation in the United States

Parent, Brendan; Moazami, Nader; Wall, Stephen; Carillo, Julius; Kon, Zachary; Smith, Deane; Walsh, B Corbett; Caplan, Arthur
Controlled heart donation after circulatory determination of death (cDCD) is well-established internationally with good outcomes and could be adopted in the United States to increase heart supply if ethical and logistical challenges are comprehensively addressed. The most effective and resource-efficient method for mitigating warm ischemia after circulatory arrest is normothermic regional perfusion (NRP) in situ. This strategy requires restarting circulation after declaration of death according to circulatory criteria, which appears to challenge the legal circulatory death definition requiring irreversible cessation. Permanent cessation for life-saving efforts must be achieved to assuage this concern and ligating principal vessels maintains no blood flow to the brain, which ensures natural progression to cessation of brain function. This practice - standard in some countries - raises unique concerns about prioritizing life-saving efforts, informed authorization from decision-makers, and the clinician's role in the patient's death. To preserve public trust, medical integrity, and respect for the donor, the donation conversation must not take place until after an un-coerced decision to withdraw life-sustaining treatment made in accordance with the patient's treatment goals. The decision maker(s) must understand cDCD procedure well enough to provide genuine authorization and the preservation/procurement teams must be kept separate from the clinical care team.
PMID: 31913567
ISSN: 1600-6143
CID: 4257412

The Stent Is Not to Blame: Lessons Learned With a Simplified US Version of the Frozen Elephant Trunk

Preventza, Ourania; Coselli, Joseph S; Mayor, Jessica; Simpson, Katherine; Carillo, Julius; Price, Matt D; Cornwell, Lorraine D; Omer, Shuab; de la Cruz, Kim I; Bakaeen, Faisal G; Jobe, Arin
BACKGROUND:We analyzed trends, assessed outcomes and lessons learned, and investigated whether using a simplified US version of the frozen elephant trunk (FET) technique to treat complex arch pathology poses additional risk. METHODS:From 2010 to 2015, we performed 129 consecutive ET procedures (traditional ET [t-ET], n = 92 [71.3%]; FET, n = 37 [28.7%]) for chronic dissecting (n = 62 [48.1%]) and atherosclerotic aneurysms (n = 67 [51.9%]). A stepwise logistic regression model using preoperative and intraoperative variables was created to analyze the outcomes. RESULTS:Thirty-day mortality was 12.4% (t-ET, n = 9 [9.8%]; FET, n = 7 [18.9%]; p = 0.24). The rate of persistent (at the time of discharge) stroke was 5.4% (t-ET, n = 5 [5.4%]; FET, n = 2 [5.4%]; p =1.00). The rate of persistent spinal cord deficit was 3.9% (t-ET, n = 3 [3.3%]; FET, n = 2 [5.4%]; p = 0.62). In the multivariable analyses, the addition of FET was not an independent predictor of mortality, permanent stroke, or spinal cord deficit. CONCLUSIONS:With the advent of endovascular technology, there is a clinical shift toward increased use of FET to eliminate or facilitate the second surgical stage in treating patients with extensive aortic pathology. The addition of FET to the surgical armamentarium does not seem to pose additional risk (although larger studies are needed), but judicious use is advised nonetheless. A single-piece endoprosthesis for FET instead of a customized one should be considered.
PMID: 28648532
ISSN: 1552-6259
CID: 3818432

Impact of concomitant mitral valve repair for severe mitral regurgitation at the time of continuous-flow left ventricular assist device insertion

Sandoval, Elena; Singh, Steve K; Carillo, Julius A; Baldwin, Andrew C W; Ono, Masahiro; Anand, Jatin; Frazier, O H; Mallidi, Hari R
OBJECTIVES:Mitral regurgitation (MR) is common in patients with end-stage heart failure. We assessed the effect of performing concomitant mitral valve repair during continuous-flow left ventricular assist device (CF-LVAD) implantation in patients with severe preoperative MR. METHODS:We performed a single-centre, retrospective review of all patients who underwent CF-LVAD implantation between December 1999 and December 2013 (n = 469). Patients with severe preoperative MR (n = 78) were identified and then stratified according to whether they underwent concomitant valve repair. Univariate and survival analyses were performed, and multivariable regression was used to determine predictors of survival. RESULTS:Of the 78 patients with severe MR, 21 underwent valve repair at the time of CF-LVAD implantation (repair group) and 57 did not (non-repair group). A comparison of the 2 groups showed significant differences between groups: INTERMACS I 16.985 vs 9.52%, (P = 0.039), cardiopulmonary bypass time 82.09 vs 109.4 min (P = 0.0042) and the use of HeartMate II 63.16 vs 100% (P = 0.001). Survival analysis suggested trends towards improved survival and a lower incidence of heart failure-related readmissions in the repair group. Multivariable regression analysis showed no significant independent predictors of survival (mitral valve repair: odds ratio 0.4, 95% confidence interval 0.8-1.5; P = 0.2). CONCLUSIONS:Despite the lack of statistical significance, trends towards improved survival and a lower incidence of heart failure events suggest that mitral valve repair may be beneficial in patients undergoing CF-LVAD implantation. Given the known relationship between severe MR and mortality, further study is encouraged to confirm the value of mitral valve repair in these patients.
PMID: 28962504
ISSN: 1569-9285
CID: 3818442

Prometheus' predicament: How to address contemporary left ventricular assist devices in patients with liver dysfunction [Comment]

Sandoval, Elena; Carillo, Julius A; Singh, Steve K
PMID: 26478237
ISSN: 1097-685x
CID: 3818422