Single-center experience of extended brain-death donor heart preservation with the organ care system.

BACKGROUND: The Organ Care System (OCS) (Transmedics, Andover, MA) reduces cold ischemic time of donor hearts by producing a normothermic beating state during ex vivo perfusion, enabling extended ex situ intervals, which potentially increases donor pool. We aimed to compare outcomes in utilization of OCS and conventional cold storage technique. METHODS: Consecutive heart transplants following brain death at our institution between May 2022 and July 2023 were analyzed. Recipients were divided into those receiving hearts preserved with OCS [N = 15] and those with conventional cold storage (Control, N = 27), with OCS utilization when anticipated ischemic time was more than 4 h. Pre-transplant characteristics and transplant outcomes were compared. RESULTS: OCS utilization allowed a significant increase in distance traveled for heart retrieval (OCS, 624 ± 269 vs. Control, 153 ± 128 miles, p < 0.001), with longer mean total preservation times (6.2 ± 1.1 vs 2.6 ± 0.6 h, p < 0.001). All but one patient displayed a general decrease or plateau in lactate throughout perfusion time by OCS. Both groups experienced similar rates of severe primary graft dysfunction (OCS, 6.7% [N = 1] vs. Control, 11.1% [N = 3], p = 0.63), with 100% in-hospital survival in the OCS group compared to 96.3% in the Control group (p = 0.34). Kaplan-Meier survival analysis showed that estimated one-year survival were comparable (OCS, 93.3 ± 6.4% vs. Control, 88.9 ± 6.0%, p = 0.61). CONCLUSION: With a mean preservation time of around 6 h and distance covered of over 600 miles, our results using OCS indicate a potential to safely increase the quantity and viability of accessible organs, thus broadening the donor pool without negatively affecting outcomes.

The Impact of Ipsilateral Implantable Cardioverter Defibrillator in Axillary Intra-Aortic Balloon Pump Support as Bridge to Heart Transplantation.

BACKGROUND: The axillary artery (AX) access for intra-aortic balloon pump (IABP) as a bridge to heart transplant (HT) allows mobility while awaiting a suitable donor. As end-stage heart failure patients often have an implantable cardioverter defibrillator (ICD) on the left side, the left AX approach may be avoided due to the perception of difficult access and proximity of two devices. We aimed to evaluate the outcomes of patients bridged to HT with a left-sided AX IABP with or without ipsilateral ICDs. METHODS: We retrospectively reviewed HT candidates at our institution supported by left-sided axillary IABP from November 2019 to February 2024, dividing them into two groups based on the presence (Group ICD, n = 48) or absence (Group No-ICD, N = 19) of an ipsilateral left-sided ICD. The exposure time was defined as the time from skin incision to the beginning of anastomoses of a Dacron graft. RESULTS: Technical success was achieved in 100% of the cohort, with median exposure times for AX access similar between groups (ICD, 12 [7.8, 18.2] vs. No ICD, 11 [7, 19] min; p = 0.75). The rate of procedural adverse events, such as significant access site bleeding and ipsilateral limb ischemia, did not significantly differ between both groups. Device malfunction rates were comparable (ICD, 29.2% vs. No ICD, 15.8%; p = 0.35). Posttransplant, in-hospital mortality, severe primary graft dysfunction, and stroke rates were comparable in both groups. CONCLUSION: The presence of an ipsilateral left-sided ICD does not adversely impact the procedural efficacy, complication rates, or posttransplant outcomes of left-sided AX IABP insertion in HT candidates.

Outpatient Continuous Intravenous Inotropy in the Modern Era.

The use of continuous inotropy in patients with advanced heart failure (HF) has been historically controversial due to the prevailing notion that it will increase mortality. In practice, clinicians have continued to revisit this idea as there remains a lack of treatment options for patients in stage D HF. Clinical trials in the past have generally not shown favorable effects of long-term chronic infusions of positive IV inotropic agents on symptoms and exercise tolerance. However, these older studies which indicated poor outcomes with palliative inotropes may not apply to current practice. Modern trials and case series have shown that milrinone and dobutamine may be safely used in patients who are bridging to device therapy or transplant or for palliation. Broad adoption of mortality-reducing modern guideline-directed medical therapy and implantable cardioverter defibrillators may have contributed to the positive results that contemporary trials have seen with inotrope use. For the stage D HF patient, modern use of outpatient inotropy (OI) can alleviate symptom burden and prolong time spent at home. Additionally, more recent studies and case series suggest that OI can be a reasonable alternative to left ventricular assist device placement for both bridging to transplant or as destination therapy. In the appropriate patient, and according to the patient's informed decision and preference, this may be a viable alternative therapeutic option. Contemporary data suggest that OI should be considered in patients who are being evaluated for advanced therapies.

Coronavirus Disease 2019 (COVID-19) in Heart Transplant Recipients and Anti-SARS-CoV-2 Monoclonal Antibodies: Experience, Lessons Learnt, and Future Challenges.

Solid organ transplant recipients (SOTRs), including heart transplant (HT) recipients, infected with Coronavirus disease 2019 (COVID-19) are at higher risk of hospitalization, mechanical ventilation, or death when compared with general population. Advances in diagnosis and treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have reduced COVID-19-related mortality rates from ~30% in the early pandemic to <3% in 2022 among HT recipients. We performed a retrospective chart review including adult HT recipients at Westchester Medical Center from January 1, 2020 to December 10, 2022, who received anti-SARS-CoV-2 monoclonal antibodies (mAbs) for treatment of mild-to-moderate COVID-19, and those who received tixagevimab/cilgavimab for preexposure prophylaxis. Additionally, a comprehensive review of the literature involving SOTRs who received mAbs for COVID-19 was conducted. In this largest single-center study in this population, 42 adult HT recipients received casirivimab/imdevimab (36%), sotrovimab (31%), or bebtelovimab (29%) for treatment of mild-to-moderate COVID-19. Among these recipients, no infusion-associated adverse effects, progression of disease, COVID-19-associated hospitalizations, or death were noted. Preexposure prophylaxis with tixagevimab/cilgavimab was given to 63 HT recipients in a dedicated infusion center (40%), inpatient setting (33%), or at time of annual heart biopsy (27%). No immediate adverse events were noted. There were 11 breakthrough infections, all mild. Overall, the data suggests that HT recipients receiving mAbs have reduced rates of hospitalization, need for intensive care unit care, or death. Use of anti-SARS-CoV-2 mAbs in SOTRs is resource intensive and requires a programmatic team approach for optimal administration and to minimize any risk of disparities in their use.

High-Risk Pulmonary Hypertension Does Not Worsen Outcomes in Heart Transplantation.

Pulmonary hypertension (PH) is a relative contraindication to heart transplantation (HT). Multiple studies showed increased mortality in patients with PH. Advances in care may have led to improved outcomes in the modern era. We analyzed patients who underwent HT at our institution between 2014 and 2018. We divided patients into 2 groups based on the presence of high-risk PH defined as either pulmonary vascular resistance >3 Wood units or transpulmonary gradient >15 mm Hg. The primary outcome was survival. Secondary outcomes were post-HT morbidity and changes in hemodynamics. Subsequently, we analyzed national trends of single organ HT recipients with a high-risk PH between 1994 and 2018 from the United Network for Organ Sharing registry. Of 98 patients who underwent HT at our center, 32% had PH. In patients without and with PH, the survival was 100% at 30 days, 87%, and 81% at 3 years (p = 0.96). In both groups, pulmonary vascular resistance and trans-pulmonary gradient decreased after HT. Nationwide data revealed 30-day survival without and with PH at 97% and 98% (p = 0.47) and 3-year survival at 86% and 87% (p = 0.84), respectively, in 2018. The proportion of recipients with PH decreased from 25% in 1994 to 19% in 2018. Recipients of HT with and without high-risk PH had similar early and late mortality in a single-center and nationwide analysis. PH improved immediately after transplant. The United Network for Organ Sharing registry analysis demonstrates continued improvement in survival in patients with PH in the modern era, whereas the relative percentage of recipients with PH decreased over time.

Impella devices: a comprehensive review of their development, use, and impact on cardiogenic shock and high-risk percutaneous coronary intervention.

INTRODUCTION: Impella devices have emerged as a critical tool for temporary mechanical circulatory support (TMCS) in the management of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (PCI). The purpose of this review is to examine the history of the different Impella devices, their hemodynamic profiles, and how the data supports their use. AREAS COVERED: This review covers the development and specifications of the Impella 2.5, Impella CP, Impella 5.0/Left Direct (LD), Impella RP, and Impella 5.5 devices. This review also covers the clinical trials that illuminate the Impella devices' use in their appropriate clinical contexts. These studies examine the effectiveness of Impella devices and have begun to yield promising results, demonstrating improved survival rates when compared to the historically high mortality rates associated with CS. It is important to weigh the benefits of Impella devices in light of their contraindications. A literature search was conducted by searching the PubMed database for reviews, meta-analyses, and clinical trials pertinent to Impella devices. EXPERT OPINION: Impella devices are a crucial tool for management of patients undergoing high-risk PCI and those with CS. There is evidence that early Impella implantation is beneficial in the treatment of patients presenting with CS. Further randomized controlled trials are needed to better elucidate the benefits of Impella devices in various clinical settings.

Evolution of concomitant use of veno-arterial extracorporeal membrane oxygenation support with Impella in cardiogenic shock: From percutaneous femoral Impella to axillary Impella 5.5.

BACKGROUND: Little is known about safety and efficacy of the use of Impella 5.5 compared to previous iterations in the setting of Impella with Veno-Arterial Extracorporeal Membrane Oxygenation Support as ECPELLA. METHODS: Consecutive patients who were treated by ECPELLA with surgically implanted axillary Impella 5.5 (N = 13) were compared with patients supported by ECPELLA with percutaneous femoral Impella CP or 2.5 (Control, N = 13). RESULTS: The total ECPELLA flow was higher in ECPELLA 5.5 group (6.9 vs. 5.4 L/min, p = 0.019). Actual hospital survival was higher than predicted and comparable in both groups (ECPELLA 5.5, 61.5% vs. Control, 53.8%, p = 0.691). Both total device complications (ECPELLA 5.5, 7.7% vs. Control, 46.1%, p = 0.021) and Impella-specific complications (ECPELLA 5.5, 0% vs. Control, 30.8%, p = 0.012) were significantly lower in the ECPELLA 5.5 group. CONCLUSIONS: Utilization of Impella 5.5 in the setting of ECPELLA provides greater hemodynamic support with a lower risk of complications compared to Impella CP or 2.5.

Emerging Modalities for Temporary Mechanical Circulatory Support in Cardiogenic Shock.

Cardiogenic shock (CS) is a life-threatening medical condition that requires prompt recognition and treatment. The use of standardized CS criteria, such as the Society for Cardiovascular Angiography and Interventions criteria, can categorize patients and guide therapeutic strategies. Temporary mechanical circulatory support (MCS) devices have become valuable tools in the treatment of CS, as they can provide cardiovascular support as a bridge to recovery, cardiac surgery, or advanced therapies such as cardiac transplant or durable ventricular assist devices. The use of MCS should be tailored to each individual patient, focused on a stepwise escalation of circulatory support to support both end-organ perfusion and myocardial recovery. As newer MCS devices reduce myocardial oxygen demand without increasing ischemia, the possibility of recovery is optimized. In this review, we discuss the different modalities of MCS focusing on the mechanism of support and the advantages and disadvantages of each device.

An Update on the Diagnosis and Management of Acute Right Heart Failure.

Right ventricular (RV) dysfunction and resultant acute right heart failure (ARHF) is a rapidly growing field of interest, driven by increasing appreciation of its contribution to heart failure morbidity and mortality. Understanding of ARHF pathophysiology has advanced dramatically over recent years and can be broadly described as RV dysfunction related to acute changes in RV afterload, contractility, preload, or left ventricular dysfunction. There are several diagnostic clinical signs and symptoms as well as imaging and hemodynamic assessments that can provide insight into the degree of RV dysfunction. Medical management is tailored to the different causative pathologies, and in cases of severe or end-stage dysfunction, mechanical circulatory support can be utilized. In this review, we describe the pathophysiology of ARHF, how its diagnosis is established by clinical signs and symptoms and imaging findings, and provide an overview of treatment options, both medical and mechanical.

Ex Vivo Heart Perfusion for Cardiac Transplantation Allowing for Prolonged Perfusion Time and Extension of Distance Traveled for Procurement of Donor Hearts: An Initial Experience in the United States.

Scarcity of donor hearts continues to be a challenge for heart transplantation (HT). The recently Food and Drug Administration-approved Organ Care System (OCS; Heart, TransMedics) for ex vivo organ perfusion enables extension of ex situ intervals and thus may expand the donor pool. Because postapproval real-world outcomes of OCS in HT are lacking, we report our initial experience. Methods: We retrospectively reviewed consecutive patients who received HT at our institution in the post-Food and Drug Administration approval period from May 1 to October 15, 2022. Patients were divided into 2 groups: OCS versus conventional technique. Baseline characteristics and outcomes were compared. Results: A total of 21 patients received HT during this period, 8 using OCS and 13 conventional techniques. All hearts were from donation after brain death donors. The indication for OCS was an expected ischemic time of >4 h. Baseline characteristics in the 2 groups were comparable. The mean distance traveled for heart recovery was significantly higher in the OCS group (OCS, 845 ± 337, versus conventional, 186 ± 188 mi; P < 0.001), as was the mean total preservation time (6.5 ± 0.7 versus 2.5 ± 0.7 h; P < 0.001). The mean OCS time was 5.1 ± 0.7 h. In-hospital survival in the OCS group was 100% compared with 92.3% in the conventional group (P = 0.32). Primary graft dysfunction was similar in both groups (OCS 12.5% versus conventional 15.4%; P = 0.85). No patient in the OCS group required venoarterial extracorporeal membrane oxygenation support after transplant compared with 1 in the conventional group (0% versus 7.7%; P = 0.32). The mean intensive care unit length of stay after transplant was comparable. Conclusions: OCS allowed utilization of donors from extended distances that otherwise would not be considered because ischemic time would be prohibitive by conventional technique.

Simple technique of distal leg perfusion during heart transplant in patients with preoperative veno-arterial extracorporeal membrane oxygenation support.

Direct heart transplant from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support is challenging. Continuation of postoperative VA-ECMO support may be required in the setting of primary graft dysfunction or severe vasoplegia. We describe a simple technique to perfuse the ipsilateral leg of an arterial ECMO cannula during heart transplant while the ECMO circuit is turned off but maintaining the arterial cannula and distal perfusion catheter in place. This technique minimizes the number of intraoperative procedures with a minimal risk of leg ischemia, and provides a smooth transition to postoperative VA-ECMO support if necessary.

COVID-19, Heart Failure Hospitalizations, and Outcomes: A Nationwide Analysis.

Heart Failure (HF) patients are at a higher risk of adverse events associated with Coronavirus disease 2019 (COVID-19). Large population-based reports of the impact of COVID-19 on patients hospitalized with HF are limited. The National Inpatient Sample database was queried for HF admissions during 2020 in the United States (US), with and without a diagnosis of COVID-19 based on ICD-10-CM U07. Propensity score matching was used to match patients across age, race, sex, and comorbidities. Multivariate logistic regression analysis was used to identify predictors of mortality. A weighted total of 1,110,085 hospitalizations for HF were identified of which 7,905 patients (0.71%) had a concomitant diagnosis of COVID-19. After propensity matching, HF patients with COVID-19 had higher rate of in-hospital mortality (8.2% vs 3.7%; odds ratio [OR]: 2.33 [95% confidence interval [CI]: 1.69, 3.21]; P< 0.001), cardiac arrest (2.9% vs 1.1%, OR 2.21 [95% CI: 1.24,3.93]; P<0.001), and pulmonary embolism (1.0% vs 0.4%; OR 2.68 [95% CI: 1.05, 6.90]; P = 0.0329). During hospitalizations for HF, COVID-19 was also found to be an independent predictor of mortality. Further, increasing age, arrythmias, and chronic kidney disease were independent predictors of mortality in HF patients with COVID-19. COVID-19 is associated with increased in-hospital mortality, longer hospital stays, higher cost of hospitalization and increased risk of adverse outcomes in patients admitted with HF.

Cannulation-related adverse events of peripheral veno-arterial extracorporeal membrane oxygenation support in heart transplantation: Axillary versus femoral artery cannulation.

BACKGROUND: In heart transplantation (HT), peripheral veno-arterial extracorporeal membranous oxygenation (VA-ECMO) is utilized preoperatively as a direct bridge to HT or postoperatively for primary graft dysfunction (PGD). Little is known about wound complications of an arterial VA-ECMO cannulation site which can be fatal. METHODS: From 2009 to 2021, outcomes of 80 HT recipients who were supported with peripheral VA-ECMO either preoperatively or postoperatively were compared based on the site of arterial cannulation: axillary (AX: N = 49) versus femoral artery (FA: N = 31). RESULTS: Patients in the AX group were older (AX: 59 years vs. 52 years, p = .006), and less likely to have extracorporeal cardiopulmonary resuscitation (0% vs. 12.9%, p = .040). Survival to discharge (AX, 81.6% vs. FA. 90.3%, p = .460), incidence of stroke (10.2% vs. 6.5%, p = .863), VA-ECMO cannulation-related bleeding (6.1% vs. 12.9%, p = .522), and arm or limb ischemia (0% vs. 3.2%, p = .816) were comparable. ECMO cannulation-related wound complications were lower in the AX group (AX, 4.1% vs. FA, 45.2%, p < .001) including the wound infections (2.0% vs. 32.3%, p < .001). In FA group, all organisms were gram-negative species. In univariate logistic regression analysis, AX cannulation was associated with less ECMO cannulation-related wound complications (Odds ratio, .23, p < .001). There was no difference between cutdown and percutaneous FA insertion regarding cannulation-related complications. CONCLUSIONS: Given the lower rate of wound complications and comparable hospital outcomes with femoral cannulation, axillary VA-ECMO may be an excellent option in HT candidates or recipients when possible.

Pharmacotherapies in Heart Failure With Preserved Ejection Fraction: A Systematic Review and Network Meta-Analysis.

Various pharmacotherapies exist for heart failure with preserved ejection fraction (HFpEF), but with unclear comparative efficacy. We searched EMBASE, Medline, and Cochrane Library from inception through August 2021 for all randomized clinical trials in HFpEF (EF >40%) that evaluated beta-blockers, mineralocorticoid receptor antagonist (MRA), angiotensin-converting enzyme inhibitors (ACE), angiotensin receptor blockers (ARB), angiotensin receptor-neprilysin inhibitor (ARNI), and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Outcomes assessed were cardiovascular mortality, all-cause mortality, and HF hospitalization. A frequentist network meta-analysis was performed with a random-effects model. We included 22 randomized clinical trials (30,673 participants; mean age = 71.7 ± 4.2 years; females = 49.3 ± 7.7%; median follow-up = 24.4 ± 11.1 months). Compared with placebo, there was no statistically significant difference in cardiovascular mortality [beta-blockers; odds ratio (OR) 0.79 (0.46-1.34), MRA; OR 0.90 (0.70-1.14), ACE OR 0.95 (0.59-1.53), ARB; OR 1.02 (0.87-1.19), ARNI; OR 0.97 (0.74-1.26) and SGLT2i; OR 1.00 (0.84-1.18)] or all-cause mortality [beta blockers; OR 0.75 (0.54-1.04), MRA; OR 0.90 (0.75-1.08) ACE; OR 1.05 (0.71-1.54), ARB; OR 1.03 (0.91-1.15), ARNI; OR 0.99 (0.82-1.20) and SGLT2i; OR 1.00 (0.89-1.13)]. The certainty in these estimates was low or very low. There was a significantly reduction in HF hospitalization with the use of SGLT2i [OR 0.71 (0.62-0.82), moderate certainty], ARNI [OR 0.77 (0.63-0.94), low certainty], and MRA [OR 0.81 (0.66-0.98), moderate certainty]; with corresponding P scores of 0.84, 0.68, and 0.58, respectively. In HFpEF, the use of beta-blockers, MRA, ACE/ARB/ARNI, or SGLT2i was not associated with improved cardiovascular or all-cause mortality. SGLT2i, ARNI, and MRA reduced the risk of HF hospitalizations.

Ecpella 5.5: An Evolution in the Management of Mechanical Circulatory Support.

There are several endovascular options for temporary mechanical circulatory support in patients with refractory cardiogenic shock. These devices are often utilized in tandem to provide maximal support, including the combination of venoarterial extracorporeal membrane oxygenation with the Impella device, termed ECPELLA. An underappreciated characteristic of mechanical circulatory support is whether they provide cardiac "replacement" and/or cardiac "assistance." Within this framework, we propose an evolution in the approach to ECPELLA utilizing the Impella 5.5, with a focus on the Impella 5.5 as the primary support device.

High flow from Impella 5.5 with partial veno-arterial extracorporeal membrane oxygenation support: Case series.

Optimal flow balance between Impella 5.5 and veno-arterial extracorporeal membrane oxygenation (ECMO) support in the setting of EC-PELLA (ECMO+Impella) is unknown. Outcomes of high Impella 5.5 flow in the setting of EC-PELLA support were reviewed (N = 7). EC-PELLA was successfully explanted in 6 patients (bridge-to-transplant, N = 1; bridge-to-recovery, N = 5). The median duration of EC-PELLA support in explanted patients was 6 days. Survival at discharge was 71.4% (5 patients). In terms of device-related events, either VA-ECMO or Impella-related complications were not experienced. The median performance level of Impella 5.5 was P5 at the time of starting EC-PELLA support and then increased with time up to the median of P8 with increment of the Impella flow, and index (L/min/m2 ). The percentage of Impella flow per total EC- PELLA flow reached 50% after 48 h of support. The vasoactive-inotropic score and serum lactate level improved after institution of EC-PELLA support as well as the pulmonary artery pressures and central venous pressure. In conclusion, a high pump flow from Impella 5.5 with partial VA-ECMO support in the setting of EC-PELLA provided great support with favorable survival and device-related complications rate.