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We engineered a textile-reinforced hydrogel vascular graft. The textile provides robustness while the hydrogel promotes endothelial cell attachment and growth. The composite enhanced macrophage activation, which increased endothelial cell migration.

BackgroundRepolarization alternans, defined as period-2 oscillation in the repolarization phase of the action potentials, is one of the cornerstones of cardiac electrophysiology as it provides a mechanistic link between cellular dynamics and ventricular fibrillation (VF). Theoretically, higher-order periodicities (e.g., period-4, period-8,…) are expected but have very limited experimental evidence.MethodsWe studied explanted human hearts, obtained from the recipients of heart transplantation at the time of surgery, using optical mapping technique with transmembrane voltage-sensitive fluorescent dyes. The hearts were stimulated at an increasing rate until VF was induced. The signals recorded from the right ventricle endocardial surface just before the induction of VF and in the presence of 1:1 conduction were processed using the Principal Component Analysis and a combinatorial algorithm to detect and quantify higher-order dynamics.ResultsA prominent and statistically significant 1:4 peak (corresponding to period-4 dynamics) was seen in three of the six studied hearts. Local analysis revealed the spatiotemporal distribution of higher-order periods. Period-4 was localized to temporally stable islands. Higher-order oscillations (period-5, 6, and 8) were transient and primarily occurred in arcs parallel to the activation isochrones.DiscussionWe present evidence of higher-order periodicities and the co-existence of such regions with stable non-chaotic areas in ex-vivo human hearts before VF induction. This result is consistent with the period-doubling route to chaos as a possible mechanism of VF initiation, which complements the concordant to discordant alternans mechanism. The presence of higher-order regions may act as niduses of instability that can degenerate into chaotic fibrillation.

Long-term continuous-flow left ventricular assist device (CFLVAD) therapy is limited by complications. Compared with stroke and renal dysfunction, post-CFLVAD bowel ischemia is poorly characterized. Adult patients who underwent first-time durable CFLVAD implantation at our institution between 2008 and 2018 were identified and screened for bowel ischemia using Current Procedural Terminology codes for abdominal surgical exploration and International Classification of Disease codes for intestinal vascular insufficiency. Patients who developed biopsy-proven bowel ischemia (cases) were matched to controls (1:1, nearest neighbor, caliper = 0.29) based on preoperative characteristics. Incidences of postoperative right heart failure and renal replacement therapy were compared using McNemar's test. One year survival was estimated using the Kaplan-Meier method. Overall, 711 patients underwent CFLVAD implantation. Nineteen (2.7%) developed bowel ischemia (cases) median 17 days postimplantation (IQR 8-71). The majority of cases were male (78.9%), Black (63.2%), received HeartMate II (57.9%), treated as destination therapy (78.9%), and had a history of hypertension (89.5%), chronic kidney disease (84.2%), hyperlipidemia (84.2%), smoking (78.9%), and atrial fibrillation (57.9%). Post-LVAD, case patients were more likely to develop moderate-severe right heart failure (89.5% vs. 68.4%, p = 0.005), require renal replacement therapy (21.1% vs. 0%, p < 0.001), and less likely to survive to discharge (52.6% vs. 89.5%, p = 0.02) compared with controls. Case subjects demonstrated worse 1 year survival. While less common than stroke and renal dysfunction, post-CFLVAD bowel ischemia is associated with high 1 year mortality. Multi-institutional registries should consider reporting abdominal complications such as bowel ischemia as an adverse event to further investigate these trends and identify predictors of this complication to reduce patient mortality.

Objective The benefits of minimally invasive adult cardiac surgery are well established. Nevertheless, minimally invasive congenital cardiac procedures, even for adult patients, are uncommon. In 2018, we started repairing anomalous aortic origin of a coronary artery (AAOCA) through a 5 cm anterior minithoracotomy when possible to improve cosmesis and avoid sternal precautions. We hypothesized this approach was safe and reliable. Methods A 5 cm incision was made in the right second intercostal space. The incision was carried down to the pericardium while preserving the internal mammary artery. With the pericardium in view, the second and third ribs were disarticulated. Central cardiopulmonary bypass was established, and the repair was carried out based on the patient’s anatomy. The technique was modified to a left anterior minithoracotomy for 1 patient who required pulmonary artery translocation. At any point, if the dissection or repair was not progressing appropriately, the minimally invasive exposure was converted to a partial or traditional median sternotomy. Results Between June 2018 and June 2019, 11 patients underwent minimally invasive anomalous coronary repair. Four patients (3 with body mass index >30) were converted to traditional sternotomy due to poor visualization. Postoperatively, 1 patient required coronary artery bypass after 335 days, due to extensive collaterals and stable angina. Otherwise, at a median follow-up of 437 days (IQR 340 to 480), patients had resumed baseline activity without recurrent symptoms. Conclusions Minimally invasive AAOCA repair may be appealing, although surgeons should be cautious given the high conversion rate.

Ex vivo lung perfusion (EVLP) allows for a reassessment of lung grafts initially deemed unsuitable for transplantation, increasing the available donor pool; however, this requires a pre- and post-EVLP period of cold ischemic time (CIT). Paucity of data exists on how the sequence of cold normothermic-cold preservations affect outcomes.A total of 110 patients were retrospectively analyzed. Duration of 3 preservation phases was measured: cold pre-EVLP, EVLP, and cold post-EVLP. The donor and recipient clinical data were collected. Primary graft dysfunction (PGD) and survival were monitored. Risk of mortality or PGD was calculated using Cox proportional hazards and logistic regression models to adjust for baseline characteristics.Using the highest quartile, patients were stratified into extended vs non-extended pre-EVLP (264 vs ≥264 minutes) and post-EVLP (287 vs ≥287 minutes) CIT. The rates of 1-year mortality (8.4% vs 29.6%, p = 0.013), PGD 2-3 (20.5% vs 52%, p = 0.002), and PGD 3 (8.4% vs 29.6%, p = 0.005) at 72 hours were increased in the extended post-EVLP CIT group. After adjusting for baseline risk factors, the extended group remained an independent predictor of PGD ≥2 (odd ratio: 6.18, 95% CI: 1.88-20.3, p = 0.003) and PGD 3 (odd ratio: 20.4, 95% CI: 2.56-161.9, p = 0.004) at 72 hours and 1-year mortality (hazard ratio: 17.9, 95% CI: 3.36-95.3, p = 0.001). Cold pre-EVLP was not a significant predictor of primary outcomes.Extended cold post-EVLP preservation is associated with a risk for PGD and 1-year mortality. Pre-EVLP CIT does not increase mortality or high-grade PGD. These findings from a multicenter trial should caution on the implementation of extended cold preservation after EVLP.

Background Sensitized candidates with unacceptable antigens are a group that demands special attention in organ transplantation. Calculated panel reactive antigen (cPRA) is not used to modify allocation priorities in lung transplantation. The impact of cPRA on waiting list time and mortality is unknown. Methods We performed a retrospective review of candidates for lung transplantation listed from May 2005 to 2018. Data from the Organ Procurement and Transplantation Network/United Network for Organ Sharing STAR (Standard Analysis and Research) dataset was paired with additional unacceptable human leukocyte antigen (UA-HLA) data, which were used to calculate the listing cPRA. Candidates were stratified based on the lack of UA-HLAs or cPRA level for candidates with unacceptable antigens reported. Unadjusted competing risks and adjusted subdistribution hazard models were fit. Results A total of 29,085 candidates met inclusion criteria for analysis. Of these, 23,562 (81%) with no UA-HLAs, 3472 (11.9%) with a cPRA less than 50, and 2051 with a cPRA greater than or equal to 50 (7.1%). On adjusted analysis, a cPRA greater than or equal to 50 was independently associated with increased waitlist mortality at 1 year (hazard ratio, 1.71; 95% confidence interval, 1.55-1.88; P Conclusions Further evaluation of organ allocation with consideration of a candidate's cPRA may be warranted in order to optimize equity in access to transplants.

Background We recently mitigated a clonal outbreak of hospital-acquired Mycobacterium abscessus complex (MABC), which included a large cluster of adult patients who developed invasive infection after exposure to heater-cooler units during cardiac surgery. Recent studies have detailed Mycobacterium chimaera infections acquired during cardiac surgery; however, little is known about the epidemiology and clinical courses of cardiac surgery patients with invasive MABC infection. Methods We retrospectively collected clinical data on all patients who underwent cardiac surgery at our hospital and subsequently had positive cultures for MABC from 2013 through 2016. Patients with ventricular assist devices or heart transplants were excluded. We analyzed patient characteristics, antimicrobial therapy, surgical interventions, and clinical outcomes. Results Ten cardiac surgery patients developed invasive, extrapulmonary infection from M. abscessus subspecies abscessus in an outbreak setting. Median time from presumed inoculation in the operating room to first positive culture was 53 days (interquartile range [IQR], 38–139 days). Disseminated infection was common, and the most frequent culture-positive sites were mediastinum (n = 7) and blood (n = 7). Patients received a median of 24 weeks (IQR, 5–33 weeks) of combination antimicrobial therapy that included multiple intravenous agents. Six patients required antibiotic changes due to adverse events attributed to amikacin, linezolid, or tigecycline. Eight patients underwent surgical management, and 6 patients required multiple sternal debridements. Eight patients died within 2 years of diagnosis, including 4 deaths directly attributable to MABC infection. Conclusions Despite aggressive medical and surgical management, invasive MABC infection after cardiac surgery caused substantial morbidity and mortality. New treatment strategies are needed, and compliance with infection prevention guidelines remains critical.

Left ventricular assist devices are (LVAD) used for circulatory support in patients with end-stage heart failure. Hemolysis/pump dysfunction is a well-known complication of this therapy with various etiologic causes. A small proportion of these complications are caused by outflow graft obstructions; this complication has received little attention in the scientific literature. Herein, we provide a comprehensive overview of the role of the LVAD outflow graft obstruction and its treatment options.

Stroke remains a significant complication of left ventricular assist device (LVAD) therapy. We performed a single-center retrospective study evaluating patients undergoing first-time HeartWare HVAD (Medtronic Inc) or HeartMate 3 (Abbott Inc) implantation from September 2009-February 2018.Exclusion criteria were age18 and preoperative ECMO. The primary endpoint was stroke-free survival. Stroke was defined as new neurological deficits persisting24 hours with corresponding radiographic evidence. Risk factors evaluated included demographics, medical comorbidities, heart failure etiology, LVAD indication, INTERMACS profile, and device type. Univariate predictors (P .15) and variables clinically suspected to raise stroke risk were entered in a multivariate hazard regression model, specified using backward selection of covariates and accounting for competing risks of transplant/LVAD exchange.A total of 163 HVAD and 84 HM3 patients were analyzed. Median follow up (until death, censoring for transplant/LVAD removal, or end of follow up) was 1.2 years in HVAD patients and 1.4 years in HM3 patients. Stroke occurred in 24 HVAD patients (15 ischemic, 9 hemorrhagic) and 6 HM3 patients (4 ischemic, 2 hemorrhagic). One-year stroke-free survival was 76.8% for HVAD and 84.3% for HM3. Thirty-day mortality following stroke was 41.7% for HVAD and 66.7% for HM3; 54.2% of HVAD strokes were disabling compared to 83.3% of HM3 strokes. Age, LVAD indication, and device type were associated (P .15) with stroke on univariate analysis. On multivariate analysis, the HVAD was associated with significantly higher stroke risk (hazard ratio, 2.57; 95% confidence interval, 1.02-6.44; P = .045).Different LVAD models appear to be associated with significantly different stroke risks.

Summary Background Donor lung use for transplantation is the lowest among solid organ tranplants because of several complex and multifactorial reasons; one area that could have a substantial role is the limited capabilities of cold ischaemic storage. The aim of the EXPAND trial was to evaluate the efficacy of normothermic portable Organ Care System (OCS) Lung perfusion and ventilation on donor lung use from extended-criteria donors and donors after circulatory death, which are rarely used. Methods In this single-arm, pivotal trial done in eight institutions across the USA, Germany, and Belgium, lungs from extended-criteria donors were included if fulfilling one or more of the following criteria: a ratio of partial pressure of arterial oxygen (PaO2) to fractional concentration of oxygen inspired air (FiO2) in the donor lung of 300 mm Hg or less; expected ischaemic time longer than 6 h; donor age 55 years or older; or lungs from donors after circulatory death that were recruited and assessed using OCS Lung. Lungs were transplanted if they showed stability of OCS Lung variables, PaO2:FiO2 was more than 300 mm Hg, and they were accepted by the transplanting surgeon. Patients were adult bilateral lung transplant recipients. The primary efficacy endpoint was a composite of patient survival at day 30 post-transplant and absence of The International Society for Heart & Lung Tranplantation primary-graft dysfunction grade 3 (PGD3) within 72 h post-transplantation, with a prespecified objective performance goal of 65%. The primary analysis population was all transplanted recipients. This trial is registered with ClinicalTrials.gov, number NCT01963780, and is now complete. Findings Between Jan 23, 2014, and Oct 23, 2016, 93 lung pairs were perfused, ventilated, and assessed on the OCS Lung. 12 lungs did not meet OCS transplantation criteria so 81 lungs were suitable for transplantation. Two lungs were excluded for logistical reasons, hence 79 (87%) of eligible lungs were transplanted. The primary endpoint was achieved in 43 (54%) of 79 patients and did not meet the objective performance goal. 35 (44%) of 79 patients had PGD3 within the initial 72 h. 78 (99%) of 79 patients had survived at 30 days post-transplant. The mean number of lung graft-related serious adverse events (respiratory failure and major pulmonary-related infection) was 0·3 events per patient (SD 0·5). Interpretation Despite missing the objective primary endpoint, the portable OCS Lung resulted in 87% donor lung use for transplantation with excellent clinical outcomes. Many lungs declined by other transplant centres were successfully transplanted using this new technology, which implies its use has the potential to increase the number of lung transplants performed worldwide. Whether similar outcomes could be obtained if these lungs were preserved on ice is unknown and remains an area for future research. Funding TransMedics Inc.

Patients with a left ventricular assist device with right ventricular failure are prioritized on the heart transplant waitlist; however, their post-transplant survival is less well characterized. We aimed to determine whether pretransplant right ventricular failure affects postoperative survival in patients with a left ventricular assist device as a bridge to transplant.We performed a retrospective review of the 2005-2018 Organ Procurement and Transplantation Network/United Network for Organ Sharing registry for candidates aged 18 years or more waitlisted for first-time isolated heart transplantation after left ventricular assist device implantation. Candidates were stratified on the basis of having right ventricular failure, defined as the need for right ventricular assist device or intravenous inotropes. Baseline demographic and clinical characteristics were compared among the 3 groups, and post-transplant survival was assessed.Our cohort included 5605 candidates who met inclusion criteria, including 450 patients with right ventricular failure, 344 patients with a left ventricular assist device and intravenous inotropes as a bridge to transplant, 106 patients with a left ventricular assist device and right ventricular assist device, and 5155 patients with a left ventricular assist device as a bridge to transplant without the need for right side support. Compared with patients without right ventricular failure, patients with a left ventricular assist device as a bridge to transplant with right ventricular failure were younger (median age 51 years, 55 vs 56 years,Patients with biventricular failure are prioritized on the waiting list, because their critical pretransplant condition has limited impact on their post-transplant survival (short-term effect only); thus, surgeons should be confident to perform transplantation in these severely ill patients. Because liver dysfunction (a surrogate marker of right ventricular failure) was found to affect long-term survival in patients with a left ventricular assist device, surgeons should be encouraged to perform transplantation in these severely ill patients after a recipient's optimization by inotropes or a right ventricular assist device because even when the bilirubin level is elevated in these patients (treated with right ventricular assist device/inotropes), their long-term survival is not affected. Future studies should assess recipients' optimization before organ acceptance to improve long-term survival.

BACKGROUND: Caregiver support is considered necessary after heart transplant (HT) and left ventricular assist device (LVAD) for patients with end-stage heart failure (HF). Few studies have demonstrated how caregivers differ by gender and race, and whether that impacts therapy eligibility. METHODS: We examined caregiver relationships among 674 patients (32% women, 55% Black) evaluated at Emory University from 2011 to 2017. Therapy readiness was assessed using the Stanford Integrated Assessment for Transplant (SIPAT). Evaluation outcome according to caregiver relationship was compared using χ(2) analysis. Multivariable logistic regression determined the association between caregiver and eligibility according to gender and race. RESULTS: Women and Black patients were less likely to have spouses as their support person (P

OBJECTIVES Long-term left ventricular assist device (LVAD) support can cause accelerated progression of aortic insufficiency (AI). The MOMENTUM trial has led to increased use of the HeartMate 3 (HM3) LVAD, due to greater hemocompatibility. However, the differential effect on the rate of progression of AI during HM3 support versus HeartMate 2 (HM2) has not been extensively studied. This analysis compares the rates of progression to moderate or severe AI (MSAI) comparing a cohort of patients supported with the HM2 versus HM3. METHODS A retrospective review was performed on all consecutive patients implanted with HM2 or HM3 between May 2005 and June 2020. Follow-up time was limited to the first 6 years after LVAD implantation. Demographics and 4005 echocardiograms were assessed for 536 HM2 and 300 HM3 patients. The primary end point was progression to MSAI. Univariable and multivariable Cox proportional hazard regression and landmark analyses were performed. RESULTS Progression to MSAI was greater in the HM2 (17%) versus HM3 (9.9%) cohort. On the univariable analysis, the hazard ratio for HM3 was 0.581 (95% confidence interval 0.370–0.909, P = 0.02) whereas on multivariable analysis hazard ratio was 0.624 (95% confidence interval 0.386–1.008, P = 0.0537). Preoperative AI, female sex and body surface area CONCLUSIONS Current practice strategies achieved low rates of progression to MSAI. Preoperative AI, female sex and body surface area

Lung transplant candidates with significant severe pulmonary artery dilation and concomitant pulmonary valve disease present a unique technical challenge. Right Ventricular Outflow Tract (RVOT) replacement at the time of double lung transplant is a feasible and safe option in this population. Reconstruction can be carried out using either the RVOT from the lung donor or a valve homograft conduit.

Clinically, both percutaneous and surgical approaches to deliver viral vectors to the heart either have resulted in therapeutically inadequate levels of transgene expression or have raised safety concerns associated with extra-cardiac delivery. Recent developments in the field of normothermic ex vivo cardiac perfusion storage have now created opportunities to overcome these limitations and safety concerns of cardiac gene therapy. This study examined the feasibility of ex vivo perfusion as an approach to deliver a viral vector to a donor heart during storage and the resulting bio distribution and expression levels of the transgene in the recipient post-transplant. The influence of components (proprietary solution, donor blood, and ex vivo circuitry tubing and oxygenators) of the Organ Care System (OC) (TransMedics, Inc., Andover MA) on viral vector transduction was examined using a cell-based luciferase assay. Our ex vivo perfusion strategy, optimized for efficient Adenoviral vector transduction, was utilized to deliver 5 × 1013 total viral particles of an Adenoviral firefly luciferase vector with a cytomegalovirus (CMV) promotor to porcine donor hearts prior to heterotopic implantation. We have evaluated the overall levels of expression, protein activity, as well as the bio distribution of the firefly luciferase protein in a series of three heart transplants at a five-day post-transplant endpoint. The perfusion solution and the ex vivo circuitry did not influence viral vector transduction, but the serum or plasma fractions of the donor blood significantly inhibited viral vector transduction. Thus, subsequent gene delivery experiments to the explanted porcine heart utilized an autologous blood recovery approach to remove undesired plasma or serum components of the donor blood prior to its placement into the circuit. Enzymatic assessment of luciferase activity in tissues (native heart, allograft, liver etc.) obtained post-transplant day five revealed wide-spread and robust luciferase activity in all regions of the allograft (right and left atria, right and left ventricles, coronary arteries) compared to the native recipient heart. Importantly, luciferase activity in recipient heart, liver, lung, spleen, or psoas muscle was within background levels. Similar to luciferase activity, the luciferase protein expression in the allograft appeared uniform and robust across all areas of the myocardium as well as in the coronary arteries. Importantly, despite high copy number of vector genomic DNA in transplanted heart tissue, there was no evidence of vector DNA in either the recipient’s native heart or liver. Overall we demonstrate a simple protocol to achieve substantial, global gene delivery and expression isolated to the cardiac allograft. This introduces a novel method of viral vector delivery that opens the opportunity for biological modification of the allograft prior to implantation that may improve post-transplant outcomes.

The syndrome of frailty for patients undergoing heart or lung transplantation has been a recent focus for perioperative clinicians because of its association with postoperative complications and poor outcomes. Patients with end-stage cardiac or pulmonary failure may be under consideration for heart or lung transplantation along with bridging therapies such as ventricular assist device implantation or venovenous extracorporeal membrane oxygenation, respectively. Early identification of frail patients in an attempt to modify the risk of postoperative morbidity and mortality has become an important area of study over the last decade. Many quantification tools and risk prediction models for frailty have been developed but have not been evaluated extensively or standardized in the cardiothoracic transplant candidate population. Heightened awareness of frailty, coupled with a better understanding of distinct cellular mechanisms and biomarkers apart from end-stage organ disease, may play an important role in potentially reversing frailty related to organ failure. Furthermore, the clinical management of these critically ill patients may be enhanced by waitlist and postoperative physical rehabilitation and nutritional optimization.

BACKGROUND: Donors with characteristics that may increase the likelihood of disease transmission with transplantation are noted as increased risk via Public Health Service criteria. This study aimed to establish the implications of declining an increased-risk donor (IRD) organ offer in lung transplantation. METHODS: Adult candidates waitlisted for isolated lung transplantation in the United States using the Organ Procurement and Transplantation Network/United Network of Organ Sharing registry from 2007 to 2017 were identified. Individual match run files identified candidate recipients who matched to an IRD offer. Competing-risks analysis ascertained the likelihood of survival to transplantation. A stratified Cox model and restricted mean survival times estimated the survival benefit associated with the acceptance of an IRD organ. RESULTS: A total of 6,963 candidates met inclusion criteria, and 1,473 (21.2%) accepted an IRD offer. Candidates who accepted an IRD offer were older, more likely to be male, and had a higher lung allocation score at the time of listing (all p < 0.05). At 1 year after an IRD offer decline, 70.5% of candidates underwent a lung transplant, 13.8% died or decompensated, and 14.9% were still awaiting transplant. Compared with those who declined, candidates who accepted the IRD offer had significantly improved cumulative mortality at 1 year (14.1% vs 23.9%, p < 0.001) and 5 years (48.4% vs 53.8%, p < 0.001). CONCLUSIONS: IRD organ declination is associated with a decreased rate of lung transplantation and worse survival. Overall post-transplant survival rates for those who survive to transplantation are equivalent.

Intra-aortic balloon pump (IABP) is often used to support patients in decompensated heart failure. Placement of the IABP via the axillary artery facilitates long-term support with the device and may allow for the conversion of an acute heart failure (HF) patient into a chronic HF patient using a modified weaning protocol; allowing for medical symptom management and removal of mechanical support. We will discuss strategies for supporting these complicated patients.

Utilization of extracorporeal membrane oxygenation (ECMO) has increased dramatically over the last decade. Despite this trend, many medical centers have limited, if any, access to this technology or the resources necessary to manage these complex patients. In an effort to improve the current infrastructure of regional ECMO care, ECMO centers of excellence have an obligation to partner with facilities within their communities and regions to increase access to this potentially life-saving technology. While the need for this infrastructure is widely acknowledged in the ECMO community, few reports describe the actual mechanisms by which a successful interfacility transport program can operate. As such, the purpose of this document is to describe the elements of and methods for providing safe and efficient mobile ECMO services from the perspective of an experienced, high-volume tertiary ECMO center of excellence in the Southeastern United States.

Background: Ex vivo lung perfusion (EVLP) allows re-evaluation of lungs initially deemed not viable for transplantation. However, the mid- and long-term outcomes after transplanting EVLP-screened lungs in a multicenter setting are still unknown. Methods: This was a multicenter, prospective, nonrandomized clinical trial. Donor lungs initially deemed not suitable (n=208) were re-evaluated on EVLP. Lungs that met quality criteria after EVLP were transplanted (n=110). Transplants performed at the same institutions using standard-criteria lungs were enrolled as controls (n=116). Primary outcomes included grade 3 primary graft dysfunction (PGD) 72 hours post-transplant and 1- and 3-year survival. Secondary outcomes included PGD 24 and 48 hours post-transplant, pulmonary function, bronchiolitis obliterans syndrome (BOS) and quality of life. Findings: Half of the lungs placed on EVLP were transplanted (102/208, 49%). The incidence of severe PGD 72 hours post-transplant was not significant different from controls (13·6% vs 6·9%, p=0.09). Moreover, survival was not significantly different 1- and 3-years post-transplant (EVLP, 86%; control, 93%; p=0·09 and EVLP, 68%; control, 77%; p=0·14, respectively). There were also no differences in pulmonary function or the incidence of BOS up to 3 years post-transplant, and no difference in quality-of-life measures 1- and 3-years post-transplant. Interpretation: In this multicenter study, recipients of lungs that were re-evaluated on EVLP and deemed suitable for transplant had similar outcomes as a recipients of a standard lung transplant. EVLP offers the opportunity to screen donated lungs initially considered high risk and can safely increase the availability of transplantable lungs without compromising outcomes. Clinical Trial Registration Details: Registered on ClinicalTrials.gov (NCT 01365429). Funding Information: XVIVO Perfusion, Inc. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: The study was approved by each transplant center’s Institutional Review Board and the FDA. Participants provided written informed consent to participate in this study.

Donation after circulatory death (DCD) heart transplantation is currently being performed in the United States as part of a clinical trial. As with all donor procurements, effective coordination between all involved teams is vital for successful organ recovery and maximal utilization of donor organs. The current discussion relays a viewpoint on combined DCD liver and heart donor procurement. Key issues highlighted include the vital importance of donor warm ischemia time (DWIT) on outcome for both recipients as well as issues pertaining to DWIT that may arise when performing combined DCD liver and heart donor procurement.

There are conflicting data regarding whether concomitant mitral valve surgery (MVS) at left ventricular assist device (LVAD) implantation is beneficial. This study aimed to assess the hemodynamic effects of concomitant MVS. Of all 73 enrolled patients, 44 patients had undergone concomitant MVS and 29 patients had not. Before LVAD implantation, MVS group had higher pulmonary capillary wedge pressure (p = 0.04). After LVAD implantation, MVS group had higher mean pulmonary artery pressure and cardiac output (CO). During the hemodynamic ramp study, MVS group had steeper CO slopes (0.18 [0.13 0.28] vs. 0.15 [0.08, 0.20] L/min/step; p = 0.04) at incremental LVAD speed and achieved a higher CO at the optimized set speed (5.5 [4.7, 6.9] vs. 4.9 [4.0, 5.7] L/min; p = 0.03). One-year freedom from death or heart failure readmission was statistically comparable between the two groups (61% vs. 80%, p = 0.20). Thus far, after LVAD implantation and concomitant MVS, patients had increased pulmonary hypertension, despite having higher CO and a better response of CO at incremental LVAD speed. The implication of hemodynamic features after concomitant MVS on clinical outcomes warrants further investigation.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a mechanical system that provides rapid and short-term support for patients with cardiac failure. In many patients, pulmonary function is also impaired, resulting in poorly-oxygenated cardiac outflow competing against well-oxygenated VA-ECMO outflow, a condition known as North-South syndrome. North-South syndrome is a primary concern because of its potential to cause cerebral hypoxia, which has a critical influence on neurological complications often seen in this patient population. In order to reduce ischemic neurological complications, it is important to understand how clinical decisions regarding VA-ECMO parameters influence blood oxygenation. Here, we studied the impacts of flow rate and cannulation site on oxygenation using a one-dimensional (1D) model to simulate blood flow. Our model was initially tested by comparing blood flow results to those observed from experimental work in VA-ECMO patients. The 1D model was combined with a two-phase flow model to simulate oxygenation. Additionally, the influence of various other clinician-tunable parameters on oxygenation in the common carotid arteries (CCAs) were tested, including, blood viscosity, cannula position within the insertion artery, heart rate, and systemic vascular resistance (SVR), as well as geometrical changes such as arterial radius and length. Our results indicated that blood oxygenation to the brain strongly depended on the cannula insertion site and the VA-ECMO flow rate with a weaker but potentially significant dependence on arterial radius. During femoral cannulation, VA-ECMO flow rates greater than ~ 4:9 L=min were needed to perfuse the CCAs. However, axillary and central cannulation began to perfuse the CCAs at significantly lower flow (~ 1 L=min). These results may help explain the incidence of cerebral hypoxia in this patient population and the common need to change cannulation strategies during treatment to address this clinical problem. While this work describes patient-averaged results, determining these relationships between VA-ECMO parameters and cerebral hypoxia is an important step towards future work to develop patient-specific models that clinicians can use to improve outcomes.

The right anterior mini-incision has emerged as an effective minimally invasive approach for adult aortic root and valve operations. However, adoption of minimally invasive techniques has been limited in congenital heart surgery. We report a case of anomalous aortic origin of the right coronary artery repair performed through this approach. Following successful right coronary artery unroofing, the patient had an uncomplicated postoperative hospitalization.

Intra-aortic balloon pump (IABP) counterpulsation has been the most widely used circulatory assist device for nearly five decades. As a result of diastolic inflation and systolic deflation, coronary blood flow is increased and afterload decreased translating into augmentation of oxygen supply and lowering of oxygen demand. In routine clinical practice, IABP is mainly used in high-risk patients with acute myocardial infarction, especially when complicated by cardiogenic shock. Further, prophylactic IABP is frequently used in patients at high risk for hemodynamic instability undergoing elective percutaneous coronary intervention or coronary artery bypass grafting. However, IABP use may be associated with serious complications, including major bleeding, thromboembolism, stroke, and vascular complications. The potential benefits of IABP must be weighed against these serious complications. This chapter describes mechanism of action, indications and contraindications for use of the IABP, insertion and timing of the device, and troubleshooting measures for common malfunctions.

ECMO therapy has evolved greatly in the last 40 years. With significant innovations to improve pump function and oxygenator and circuit biocompatibility, ECMO is now a viable option for adult patients with heart failure. ECMO has been used for support due to cardiogenic shock, post-cardiotomy shock, septic shock, cardiopulmonary resuscitation, and the need for a bridge to heart transplant or durable ventricular support. Regardless of the indication, survival after ECMO for cardiac failure is dependent on 1) timely initiation of support, 2) prevention of end-organ failure, 3) the absence of neurological injury, 4) avoidance of left ventricular distention, and 5) the ability to wean support in a timely fashion.

Purpose An increasing number of patients with end-stage heart failure are supported with left ventricular assist device (LVAD) implantation and must be maintained on a consistent anticoagulation regimen. Pre-emptive extraction of carious teeth in these patients is necessary to prevent seeding of the implanted device and endocarditis. Thus, the objective of this study was to evaluate bleeding complications after minor oral surgery, specifically teeth extractions, in this unique patient population requiring long-term anticoagulation. Materials and Methods This study was a retrospective single-center review. Adult patients supported on an implanted continuous-flow LVAD from January 1, 2007 to December 31, 2016 were included. Baseline characteristics were collected by retrospective chart review and the institutional LVAD registry. All extractions were performed in the operating room under local anesthesia with moderate sedation or general anesthesia with nasal intubation, and LVAD settings were monitored by a trained perfusionist. Preoperative and postoperative hematology laboratory values, such as hemoglobin and international normalized ratio (INR), were collected by chart review. Continuous variables were presented as mean ± standard deviation and compared using the Student t test. Categorical variables were presented as proportion and percentage and compared using the χ2 test or Fisher exact test as appropriate. Statistical significance was established at a P value less than .05. Results After screening 798 patients, 32 (4%) were found to have undergone dental extractions after LVAD implantation. The sample was composed of 32 patients with a mean age of 60.13 years and 81.25% were men. The average time from LVAD implantation to extraction was 445.19 ± 1,108.53 days. Average preoperative INR was 1.76 ± 0.47. Preoperative fresh frozen plasma was not administered to any patients. Twenty-eight patients (87.5%) were on Coumadin (warfarin) preoperatively. In 11 of these 28 patients (39.3%), Coumadin was held preoperatively. The average postoperative change in hemoglobin level was −0.79 ± 1.45. Only 1 patient (3%) required postoperative blood transfusion for a hemoglobin level of 7.6 that responded appropriately. There were no reoperations for bleeding. Conclusions Minor oral surgical procedures can be performed safely for patients being supported on LVAD therapy. With primary closure of the gingiva at the site of extraction, dental extractions can be performed without the full reversal of anticoagulation.

Objectives This study sought to determine the durability of tricuspid valve repair (TVr) performed concurrently with left ventricular assist device (LVAD) implantation and its association with the development of late right heart failure (RHF). Background Surgical management of tricuspid regurgitation (TR) at the time of LVAD implantation is performed in an attempt to reduce the occurrence of postoperative RHF. Limited data exist regarding the durability of TVr in patients with LVAD as well as its impact on development of late RHF. Methods A retrospective review was conducted of consecutive adult patients who underwent durable LVAD implantation and concurrent TVr at the authors’ institution between 2009 and 2017. Late RHF was defined as readmission for HF requiring inotropic or diuretic therapy. TVr failure was defined as moderate or severe TR at any follow-up echocardiographic examination after LVAD implantation. Results A total of 156 patients underwent LVAD and concurrent TVr during the study. Of the total, 59 patients (37.8%) had a failed TVr. The mean duration of echocardiographic follow-up was 23 ± 22 months. Of the 146 patients who were discharged after the index hospitalization, 53 patients (36.3%) developed late RHF. Multivariate Cox proportional hazard analysis demonstrated that TVr failure was an independent predictor of late RHF development (hazard ratio: 2.62; 95% confidence interval: 1.38 to 4.96; p = 0.003). Conclusions Failure of TVr in this cohort occurred at a significant rate. Failure of TVr is an independent risk factor for development of late RHF. Future studies should investigate strategies to reduce recurrence of significant TR.

Changes in heart transplantation (HT) donor and recipient demographics may influence the incidence of primary graft dysfunction (PGD). We conducted a retrospective study to evaluate PGD incidence, trends, and associated risk factors by analyzing consecutive adult patients who underwent HT between January 2009 and December 2014 at our institution. Patients were categorized as having PGD using the International Society for Heart & Lung Transplantation (ISHLT)–defined criteria. Variables, including clinical and demographic characteristics of donors and recipients, were selected to assess their independent association with PGD. A time-trend analysis was performed over the study period. Three-hundred seventeen patients met inclusion criteria. Left ventricular PGD, right ventricular PGD, or both, were observed in 99 patients (31%). Risk factors independently associated with PGD included ischemic time, recipient African American race, and recipient amiodarone treatment. Over the study period, there was no change in the PGD incidence; however, there was an increase in the recipient pretransplantation use of amiodarone. The rate of 30-day mortality was significantly elevated in those with PGD versus those without PGD (6.06% vs 0.92%, P = .01). Despite recent advancements, incidence of PGD remains high. Understanding associated risk factors may allow for implementation of targeted therapeutic interventions.

Femoral arterial cannulation in adult venoarterial (VA) extracorporeal membrane oxygenation (ECMO) predisposes patients to ipsilateral limb ischemia. Placement of a distal perfusion catheter (DPC) is one of few techniques available to prevent or manage this complication. Although frequently used, the indications for and timing of DPC placement are poorly characterized, and no guidelines are available to guide its use. The purpose of this study was to compare the incidences of vascular complications and limb ischemia between patients who did and did not receive a DPC at the time of primary ECMO cannulation. Between June 2009 and April 2015, 132 adults underwent VA ECMO cannulation at our institution. Of the 80 femoral cannulations comprising this retrospective single-center study cohort, 14 (17.5%) received a DPC at the time of primary cannulation. Demographics, indications for ECMO, and cardiovascular history and risk factors were not significantly different between comparison groups. Median arterial cannula size was 17 French in both groups. Vascular complications occurred in 2 of the 14 patients with initial DPC (14.3%) compared with 21 of 66 without initial DPC (31.8%; p = 0.188). Limb ischemia occurred in 2 of 14 patients in the DPC group (14.3%) and 15 of 66 in the non-DPC group (22.7%; p = 0.483). In-hospital mortality was comparable between groups. DPC placement at the time of primary cannulation may lower the incidence of limb ischemia. The benefit of DPC placement once evidence of limb ischemia is apparent remains unclear.

Background Outcome of mitral valve replacement in extreme scenarios of small mitral annulus with the use of the Regent mechanical aortic valve is not well documented. Methods Records were examined in 31 consecutive patients who underwent mitral valve replacement with the use of the aortic Regent valve because of a small mitral annulus. Results Mean age was 60 ± 14 years. Mitral stenosis or mitral annulus calcification was present in 30 of 31 patients (97%). Concurrent procedures were performed in 17 of 31 patients (55%). Median valve size was 23 mm. Mean mitral gradient coming out of the operating room was 4.2 ± 1.5 mm Hg and at follow-up echocardiogram performed at a median of 32 months after the procedure was 5.8 ± 2.4 mm Hg. Conclusions A Regent aortic mechanical valve can be a viable option with a larger orifice area than the regular mechanical mitral valve in a problematic situation of a small mitral valve annulus. Moreover, the pressure gradients over the valve are acceptable intraoperatively and over time.

Extracorporeal membrane oxygenation (ECMO) is employed to rescue patients with early graft dysfunction after lung transplantation (LTx). Rates of post-LTx ECMO and subsequent outcomes have been limited to single-center reports.UNOS registry was queried for LTx recipients from March 2015 to March 2016; 2,001 recipients were identified and stratified by need for post-LTx ECMO. Logistic regression was used to determine variables associated with post-LTx ECMO. Cox proportional hazards modeling identified factors associated with survival. Kaplan-Meier analysis with log-rank testing was employed for survival analysis.Of 2,001 recipients identified, 107 required post-LTx ECMO (5.1%). Recipients requiring ECMO were younger (56 vs 60 years, p = 0.007) and had higher body mass index (27.2 vs 25.8, p = 0.012). Recipients requiring post-LTx ECMO were more likely to have required mechanical ventilation before transplant (9.3% vs 4.9%, p = 0.049) and were more likely to have required pre-transplant ECMO (15% vs 3.7%, p0.001). On multivariable analysis, pre-transplant ECMO and increasing ischemic time were associated with post-LTx ECMO. Six-month survival for recipients requiring ECMO was 62.2%. On multivariable analysis, need for post-transplant dialysis was associated with mortality. Six-month survival for recipients requiring ECMO with and without dialysis was 25.8% and 86.7% (p0.001).In a nationally representative database, ischemic time and pre-transplant ECMO and/or ventilator requirement were associated with need for post-LTx ECMO. Need for post-transplant dialysis was associated with mortality in patients requiring post-LTx ECMO. These data may permit improved prediction of graft dysfunction. Strategies to minimize renal toxicity in the perioperative phase may lead to improved early survival post-LTx.

The use of venovenous extracorporeal membrane oxygenation is increasing worldwide. These patients often require noncardiac surgery. In the perioperative period, preoperative assessment, patient transport, choice of anesthetic type, drug dosing, patient monitoring, and intraoperative and postoperative management of common patient problems will be impacted. Furthermore, common monitoring techniques will have unique limitations. Importantly, patients on venovenous extracorporeal membrane oxygenation remain subject to hypoxemia, hypercarbia, and acidemia in the perioperative setting despite extracorporeal support. Treatments of these conditions often require both manipulation of extracorporeal membrane oxygenation settings and physiologic interventions. Perioperative management of anticoagulation, as well as thresholds to transfuse blood products, remain highly controversial and must take into account the specific procedure, extracorporeal membrane oxygenation circuit function, and patient comorbidities. We will review the physiologic management of the patient requiring surgery while on venovenous extracorporeal membrane oxygenation.

We present a case series of seven patients with suspected cold agglutinin antibodies, discovered after initiation of bypass. Laboratory analysis of blood samples intraoperatively determined the cause of the aggregation to be rouleaux formation in three of the patients and cold agglutinins in the other four.

Purpose As the role of extracorporeal life support (ECLS) continues to evolve in the adult and pediatric populations, smaller studies and case reports have described successful use of ECLS in specific groups of pediatric trauma patients. To further define the role of ECLS in pediatric trauma, we examined indications and outcomes for use of ECLS in injured children using a large national database. Methods All trauma patients ≤18years old were identified from the 2007 to 2011 National Trauma Data Bank. We collected patient demographics, mechanism of injury, injury severity, use of ECLS, and survival to discharge. Children undergoing ECLS were compared to those who did not undergo ECLS, using a 3:1 propensity matched analysis to compare outcomes between ECLS and non-ECLS patients with similar injury patterns. Results Of 589,895 pediatric trauma patients identified, 36 patients underwent ECLS. Within the ECLS cohort, 21/36 (58%) survived, and 10/36 (28%) were discharged directly home. Most ECLS patients were between 15 and 18years 20/36 (56%). Mechanisms of injury (MOI) resulting in ECLS use included: motor vehicle collision (MVC) 16/36 (44%), gunshot wound (GSW) 6/36 (17%), burns 6/36 (17%), and drowning/suffocation (D/S) 5/36 (14%). Among the ECLS cohort, survival varied by MOI from 75% in D/S to 56% in MVC and 33% in GSW and was 55% in patients with significant head injuries. Using propensity analysis for matched injury patterns, survival for ECLS and non-ECLS patients was similar (58% vs. 65%, p =0.61). Conclusions In the largest study to date of ECLS support in pediatric trauma patients, we found encouraging survival rates to discharge, comparable to patients not undergoing ECLS with similar injuries. These results support further use and focused research of ECLS in pediatric trauma, including drowning, burn, and MVC victims and those with significant head injuries. Level of evidence Level III; treatment study.

Background The Impella (ABIOMED, Danvers, MA) is a temporary left ventricular support device, intended for short-term cardiac support for percutaneous procedures and cardiac shock. The Impella device is available in several sizes capable of producing different flows. It is FDA approved for up to 6 days of support. The device can provide significantly higher blood flow than an intra-aortic balloon pump and can be implanted percutaneously. We sought to describe potential complications and outcomes associated with extended Impella use for cardiogenic shock. Methods We retrospectively evaluated patients who underwent implantation of either the Impella CP (Impella 3.5) or Impella 5.0 from September 1, 2017 to September 1, 2019 at our institution. Hemolysis was defined as plasma free hemoglobin level > 50 mg/dL, a lactate dehydrogenase (LDH) level > 500 units/L, and bilirubin increase > 1 mg/dL. Results 58 patients underwent percutaneous insertion of an Impella device, with the indication of cardiogenic shock in 32 patients (55%). In these 32 patients, only one had an Impella 2.5 device, 21 had an Impella CP (66%), and 10 (31%) had an Impella 5.0. The average age at time of implantation was 55 ± 17 years, and 25 patients were male (78%). Ejection fraction was 17 ± 11.7%. The average duration of Impella support was 5.5 days (1, 16 days). Complications included hematoma at the time of insertion (3 patients), leg ischemia (2 patients), improper positioning (7 patients), acute renal failure (28 patients), and hemolysis (20 patients). Hemolysis developed in 12 patients (57%) with the Impella CP and in 8 patients (80%) with the Impella 5.0, with an average LDH of 1452 units/L. 8 patients were transitioned to veno-arterial (VA) extracorporeal membrane oxygenation (ECMO), with the Impella utilized for left ventricular venting. 9 patients (28%) eventually underwent durable left ventricular assist device (LVAD) implantation on average 7 ± 6.1 days after Impella, and two patients underwent heart transplantation, both 9 days following Impella insertion. 23 patients (72%) did not survive past the initial hospitalization. Conclusion The Impella is a percutaneous temporary left ventricular support device used to provide additional cardiac output in patients with cardiogenic shock. Serious complications can occur with extended support, including hemolysis, acute renal failure, and high mortality. Of our 28 patients who received an Impella, 11 were able to be successfully bridged to either LVAD or heart transplantation with the Impella.

Purpose EVLP allows for reassessment of lung grafts initially deemed unsuitable for transplantation, increasing the available donor pool. Standard cold preservation is followed by normothermic EVLP, then lungs undergo a second cold preservation prior to implantation. Paucity of data exist on how the sequence of cold-normothermic-cold preservations affect outcomes. We investigated the effects of preservation times in transplanted EVLP lungs. Methods Data from the NOVEL trial (110pts) was retrospectively analyzed. Duration of the 3 preservation phases was measured: cold pre EVLP; EVLP; cold post EVLP. Donor and recipient clinical data were collected. Primary graft dysfunction (PGD) and survival were monitored. Risk of mortality or PGD were calculated using Cox-proportional hazards and logistic regression models to adjust for baseline characteristics. Results Using the highest quartile, pts were stratified in extended (>287 min, n=27) and non-extended ( Conclusion Extended cold post EVLP preservation (5 hrs or more) associated with risk for PGD and 1-year mortality. These findings from a multicenter trial should caution on the implementation of extended cold preservation post EVLP.