Does lung procurement and exposure to Perfadex impact heart transplantation outcomes.

INTRODUCTION: Some studies have shown increased incidence of Primary Graft Dysfunction (PGD) after heart and lung procurement for heart transplant recipients. There have been limited investigations of the impact of lung procurement on heart procurement and the potential effects of the exposure to the type of lung preservation solution, the volume of the lung preservation solution and adequacy of decompression of the heart during heart and lung procurement and the impact on heart transplant outcomes. METHODS: Adult heart transplant recipients in the UNOS database recorded from January 1, 2000 to June 30, 2022 formed the study cohort. Any heart that was procured with a lung team that utilized Perfadex preservation solution (XVIVO, Gothenburg, Sweden) was classified as exposed to Perfadex and otherwise classified as not exposed to Perfadex. Lung procurements performed with a preservation solution other than Perfadex or unknown were excluded (n = 2486). Simple comparisons were made with t-tests or chi-squared tests. Logistic regression models were used to predict 30 day and 1 year survival. Accelerated failure time models were employed to analyze time to death and time to rejection. RESULTS: The cohort consisted of 34 192 heart transplants, of which 21 928 donors were not exposed to Perfadex (64.1%). There were statistically, but not clinically, significant differences in donor characteristics for these groups including in donor age (33.34 ± 11.01 not exposed vs. 30.70 ± 10.69 exposed; p < .001), diabetic donor (4% not exposed vs. 3% exposed; p = .004), and ischemic time (3.28 ± 1.09 h not exposed vs. 3.24 ± 1.05 h exposed; p = .002). In adjusted models, for all included donors, Perfadex exposure was associated with increased short term mortality, but no long term difference (1 year mortality OR 1.10, p = .014). CONCLUSION: Perfadex exposure was associated with increased short-term mortality for heart transplant recipients. Mechanistic investigation is warranted.

Veno-venous ECLS rescue for a heart transplant recipient with COVID-19, a case report.

The potential for increased rates of morbidity of SARS-CoV-2 within immunocompromised populations has been of concern since the pandemic's onset. Transplant providers and patients can face particularly challenging situations, in the current settings as data continues to emerge for the prevention and treatment of the immunocompromised subpopulation. This case report details a patient 9-months post orthotopic heart transplant that developed SARS-CoV-2 infection despite two prior doses of the Pfizer-BioNtech COVID-19 vaccine, and had successful rescue from refractory hypoxemia with veno-venous extracorporeal membrane oxygenation (VV ECLS).

Heart failure related cardiogenic shock: An ISHLT consensus conference content summary.

In recent years, there have been significant advancements in the understanding, risk-stratification, and treatment of cardiogenic shock (CS). Despite improved pharmacologic and device-based therapies for CS, short-term mortality remains as high as 50%. Most recent efforts in research have focused on CS related to acute myocardial infarction, even though heart failure related CS (HF-CS) accounts for >50% of CS cases. There is a paucity of high-quality evidence to support standardized clinical practices in approach to HF-CS. In addition, there is an unmet need to identify disease-specific diagnostic and risk-stratification strategies upon admission, which might ultimately guide the choice of therapies, and thereby improve outcomes and optimize resource allocation. The heterogeneity in defining CS, patient phenotypes, treatment goals and therapies has resulted in difficulty comparing published reports and standardized treatment algorithms. An International Society for Heart and Lung Transplantation (ISHLT) consensus conference was organized to better define, diagnose, and manage HF-CS. There were 54 participants (advanced heart failure and interventional cardiologists, cardiothoracic surgeons, critical care cardiologists, intensivists, pharmacists, and allied health professionals), with vast clinical and published experience in CS, representing 42 centers worldwide. State-of-the-art HF-CS presentations occurred with subsequent breakout sessions planned in an attempt to reach consensus on various issues, including but not limited to models of CS care delivery, patient presentations in HF-CS, and strategies in HF-CS management. This consensus report summarizes the contemporary literature review on HF-CS presented in the first half of the conference (part 1), while the accompanying document (part 2) covers the breakout sessions where the previously agreed upon clinical issues were discussed with an aim to get to a consensus.

Consensus statements from the International Society for Heart and Lung Transplantation consensus conference: Heart failure-related cardiogenic shock.

The last decade has brought tremendous interest in the problem of cardiogenic shock. However, the mortality rate of this syndrome approaches 50%, and other than prompt myocardial revascularization, there have been no treatments proven to improve the survival of these patients. The bulk of studies have been in patients with acute myocardial infarction, and there is little evidence to guide the clinician in those patients with heart failure cardiogenic shock (HF-CS). An International Society for Heart and Lung Transplant consensus conference was organized to better define, diagnose, and manage HF-CS. There were 54 participants (advanced heart failure and interventional cardiologists, cardiothoracic surgeons, critical care cardiologists, intensivists, pharmacists, and allied health professionals) with vast clinical and published experience in CS, representing 42 centers worldwide. This consensus report summarizes the results of a premeeting survey answered by participants and the breakout sessions where predefined clinical issues were discussed to achieve consensus in the absence of robust data. Key issues discussed include systems for CS management, including the "hub-and-spoke" model vs a tier-based network, minimum levels of data to communicate when considering transfer, disciplines that should be involved in a "shock team," goals for mechanical circulatory support device selection, and optimal flow on such devices. Overall, the document provides expert consensus on some important issues facing practitioners managing HF-CS. It is hoped that this will clarify areas where consensus has been reached and stimulate future research and registries to provide insight regarding other crucial knowledge gaps.

Serial Assessment of Shock Severity in Cardiac Intensive Care Unit Patients.

BACKGROUND: One-time assessment of the Society for Cardiovascular Angiography and Interventions (SCAI) shock classification robustly predicts mortality in the cardiac intensive care unit (CICU). We sought to determine whether serial SCAI shock classification could improve risk stratification. METHODS AND RESULTS: Unique admissions to a single academic level 1 CICU from 2015 to 2018 were included in this retrospective cohort study. Electronic health record data were used to assign the SCAI shock stage during 4-hour blocks of the first 24 hours of CICU admission. Shock was defined as hypoperfusion (SCAI shock stage C, D, or E). In-hospital death was evaluated using logistic regression. Among 2918 unique CICU patients, 1537 (52.7%) met criteria for shock during ≥1 block, and 266 (9.1%) died in the hospital. The SCAI shock stage on admission was: A, 37.6%; B, 31.5%; C, 25.9%; D, 1.8%; and E, 3.3%. Patients who met SCAI criteria for shock on admission (first 4 hours) and those with worsening SCAI shock stage after admission were at higher risk for in-hospital death. Each higher admission (adjusted odds ratio, 1.36 [95% CI, 1.18-1.56]; area under the receiver operating characteristic curve, 0.70), maximum (adjusted odds ratio, 1.59 [95% CI, 1.37-1.85]; area under the receiver operating characteristic curve, 0.73) and mean (adjusted odds ratio, 2.42 [95% CI, 1.99-2.95]; area under the receiver operating characteristic curve, 0.78) SCAI shock stage was incrementally associated with a higher in-hospital mortality rate. Discrimination was highest for the mean SCAI shock stage (P<0.05). Each additional 4-hour block meeting SCAI criteria for shock predicted a higher mortality rate (adjusted odds ratio, 1.15 [95% CI, 1.07-1.24]). CONCLUSIONS: Dynamic assessment of shock using serial SCAI shock classification assignment can improve mortality risk stratification in CICU patients by quantifying the magnitude and duration of shock.

Safety and Performance of the Aortix Device in Acute Decompensated Heart Failure and Cardiorenal Syndrome.

BACKGROUND: Cardiorenal syndrome (CRS) complicates 33% of acute decompensated heart failure (ADHF) admissions, and patients with persistent congestion at discharge have high 30-day event rates. OBJECTIVES: The purpose of this study was to evaluate a novel catheter-deployed intra-aortic entrainment pump (IAEP) in patients with ADHF with CRS and persistent congestion. METHODS: A multicenter (n = 14), nonrandomized, single-arm, safety and feasibility study of IAEP therapy was conducted. Within patient changes (post-pre IAEP therapy) in fluid loss, hemodynamics, patient-reported dyspnea, and serum biomarkers were assessed using Wilcoxon signed-rank testing. RESULTS: Of 21 enrolled patients, 18 received Aortix therapy. Mean ± SD patient age was 60.3 ± 7.9 years. The median left ventricular ejection fraction was 22.5% (25th-75th percentile: 10.0%-53.5%); 27.8% had a left ventricular ejection fraction ≥50%. Pre-therapy, patients received 8.7 ± 4.1 days of loop diuretic agents and 44% were on inotropes. Pump therapy averaged 4.6 ± 1.6 days, yielding net fluid losses of 10.7 ± 6.5 L (P < 0.001) and significant (P < 0.01) reductions in central venous pressure (change from baseline: -8.5 mm Hg [25th-75th percentile: -3.5 to -10.0 mm Hg]), pulmonary capillary wedge pressure (-11.0 mm Hg [25th-75th percentile: -5.0 to -14.0 mm Hg]), and serum creatinine (-0.2 mg/dL [25th-75th percentile: -0.1 to -0.5 mg/dL]) with improved estimated glomerular filtration rate (+5.0 mL/min/1.73 m2 [25th-75th percentile: 2.0-9.0 mL/min/1.73 m2]) and patient-reported dyspnea score (+16 [25th-75th percentile: 3-37]). Dyspnea scores, natriuretic peptides, and renal function improvements persisted through 30 days. CONCLUSIONS: This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion using IAEP therapy. These initial promising results provide the basis for future randomized clinical trials of this novel pump. (An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome [The Aortix CRS Pilot Study]; NCT04145635).

Left Ventricular Unloading With Impella Versus IABP in Patients With VA-ECMO: A Systematic Review and Meta-Analysis.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) use for circulatory support in cardiogenic shock results in increased left ventricular (LV) afterload. The use of concomitant Impella or intra-aortic balloon pump (IABP) have been proposed as adjunct devices for LV unloading. The authors sought to compare head-to-head efficacy and safety outcomes between the 2 LV unloading strategies. We conducted a search of Medline, EMBASE, and Cochrane databases to identify studies comparing the use of Impella to IABP in patients on VA-ECMO. The primary outcome of interest was in-hospital mortality. The secondary outcomes included transition to durable LV assist devices/cardiac transplantation, stroke, limb ischemia, need for continuous renal replacement therapy, major bleeding, and hemolysis. Pooled risk ratios (RRs) with 95% confidence interval and heterogeneity statistic I2 were calculated using a random-effects model. A total of 7 observational studies with 698 patients were included. Patients on VA-ECMO unloaded with Impella vs IABP had similar risk of short-term all-cause mortality, defined as either 30-day or in-hospital mortality- 60.8% vs 64.9% (RR 0.93 [0.71 to 1.21], I2 = 71%). No significant difference was observed in transition to durable LV assist devices/cardiac transplantation, continuous renal replacement therapy initiation, stroke, or limb ischemia between the 2 strategies. However, the use of VA-ECMO with Impella was associated with increased risk of major bleeding (57.2% vs 39.7%) (RR 1.66 [1.12 to 2.44], I2 = 82%) and hemolysis (31% vs 7%) (RR 4.61 [1.24 to 17.17], I2 = 66%) compared with VA-ECMO, along with IABP. In conclusion, in patients requiring VA-ECMO for circulatory support, the concomitant use of Impella or IABP had comparable short-term mortality. However, Impella use was associated with increased risk of major bleeding and hemolysis.

Conversion to tacrolimus alone compared to full immunosuppression following cardiac transplantation (TACTFUL).

BACKGROUND: Cardiac transplantation requires lifelong immunosuppressant medications to prevent rejection. However, some patients may not tolerate multiple immunosuppressants due to adverse effects. At our institution, patients may be converted to monotherapy with tacrolimus if unable to tolerate a combination regimen. This study evaluated the outcomes among patients converted to tacrolimus monotherapy compared with those maintained on combination immunosuppression. METHODS: This single-center, retrospective cohort study included patients who received heart transplants at Sentara Norfolk General Hospital between January 2015 and July 2021. Patients were classified as receiving tacrolimus monotherapy (Mono) or combination immunosuppression (Combo). The primary outcome was all-cause mortality with key secondary outcomes including incidence of 2R/3R rejection, necessity for renal replacement therapy, and infection. RESULTS: 112 patients were included (Mono = 25, Combo = 87). Median age at transplant was 53.8 years (Mono) and 52.1 years (Combo). The most common reasons for conversion to monotherapy were leukopenia, infection, and gastrointestinal (GI) distress. There was no difference in mortality (0 in Mono, 11 in Combo; p = .09) or percentage of patients with 2R/3R rejection (24% in Mono, 32.2% in Combo; p = .43). No Mono group patients experienced rejection after converting from combination therapy. 24% of Mono group patients resumed at least one additional immunosuppressive medication during the study period. Median time to monotherapy was 9.0 months, with a total median duration on monotherapy of 16.0 months. A median of 3.3 years of follow-up was observed for patients in Mono and 3.4 years in Combo (p = .29). CONCLUSION: Selected patients who do not tolerate combination immunosuppression can be safely transitioned to tacrolimus monotherapy as a means of controlling adverse events without an increased risk of mortality or rejection.

Do outcomes for heart transplantation differ based on donor and recipient race?

PURPOSE: There are limited data examining the impact of both donor and recipient race on outcomes following orthotopic heart transplant (OHT). The purpose of this study was to evaluate the relationship between donor and recipient race and OHT outcomes. METHODS: The United Network for Organ Sharing (UNOS) database was retrospectively reviewed from January 2000 to March 2018 for donor hearts. A comparison was conducted based on donor and recipient race (White, Black, Hispanic, Other/Unknown). Races for which there were limited numbers were excluded from the analysis (Asian, n = 1292; American Indian, n = 132; Pacific Islander, n = 132, Multiple ethnicities, n = 225). The primary endpoint was survival at 30 days, 1 year survival, and post-transplant rejection. Logistic and Cox models were used to quantify survival endpoints. RESULTS: A total of 41 841 OHT were included. Of the recipients, 29 894 (71%) were White, 8475 (20%) were Black, and 3472 (8%) were Hispanic. Of the donors 27 783 (66%) were White, 6277 (15%) were Black, 6576 (16%) were Hispanic, and 1205 (3%) were Unknown/Other race. In a comparison of recipient demographics, White recipients were older (54.09 ± 12.21 years) compared to Black (49.44 ± 12.83 years) and Hispanic (49.97 ± 13.27 years) recipients. All other differences between groups were not clinically significant. Black recipients were more likely to receive a heart with an "urgent" status (probability .80) compared to White (.73) and Hispanic (.75) recipients (p < .001). Hispanic recipients were more likely to receive a transplant when listed as "non-urgent" (Probability .47) compared to White (.37) and Black (.30) recipients (p < .001). In terms of outcomes, compared to White recipients, Hispanic patients experienced a decreased 30-day survival (OR 1.27; p = .011) and 1-year survival (OR 1.17; p = .016). In comparing Donor/Recipient combinations compared to a White Donor/White Recipient combination, overall survival was decreased in White donor/African American recipient (HR 1.36; p < .001), African American donor/African American recipient (HR 1.41; p < .001) and Hispanic donor/African American recipient (HR 1.30; p < .001) combinations (Table 1). CONCLUSIONS: African American and Hispanic recipients have decreased survival compared to White recipients after heart transplant. The African American donor does not decrease survival. Racial differences still exist in donor and recipient characteristics and recipient outcomes after OHT. Increasing the donor pool for all races and ethnicities would potentially benefit all recipients. Continued study is warranted in order to minimize these differences among recipients and identify factors that could be contributing to decreased survival, in order to optimize outcomes for African American and Hispanic recipients post-transplant and eliminate disparities.

The changing face of cardiogenic shock: definitions, epidemiology, and severity assessment.

PURPOSE OF REVIEW: Cardiogenic shock (CS) has been recognized for >50 years, most commonly in the setting of myocardial infarction. This review covers recent advances in the definitions, epidemiology and severity assessment of cardiogenic shock. RECENT FINDINGS: In this review, the authors discuss the evolving definitions of cardiogenic shock, detailing the early approaches as well as more contemporary ideas. The epidemiology of CS is reviewed and then granular detail on the assessment of shock severity is provided including the role of lactate measurement and invasive hemodynamic assessment. The development of the Society for Cardiac Angiography and Intervention (SCAI) consensus statement on Classification of Cardiogenic Shock is reviewed by the principal authors. The revised SCAI Shock document is reviewed as well and the future directions for assessment of shock along with clinical applications are reviewed. SUMMARY: Cardiogenic shock mortality has not changed in a significant way in many years. Recent advances such as more granular assessment of shock severity have the potential to improve outcomes by allowing research to separate the patient groups which may respond differently to various therapies.

Clinical outcomes of ventricular assist device support by HIV infection status: An STS-INTERMACS analysis.

BACKGROUND: Cardiovascular disease remains the leading cause of mortality in human immunodeficiency virus-infected (HIV-positive) patients. Ventricular assist device therapy is rarely offered to these patients and data on outcomes are sparse. We investigated outcomes following ventricular assist device implants for HIV-positive as compared to non-HIV-infected (HIV-negative) patients. METHODS: We analyzed 22,065 patients from the Interagency Registry for Mechanically Assisted Circulatory Support registry for outcomes by HIV status. A propensity-matched analysis adjusting for 21 preimplant risk factors was also conducted. RESULTS: Compared with 21,980 HIV-negative device recipients, the 85 HIV-positive recipients were younger (median age 58 years vs 59 years, p = 0.02), had lower body mass index (26 kg/m2 vs 29 kg/m2, p = 0.001), and had higher rates of prior stroke (8% vs 4%, p = 0.02). In the matched HIV-positive and HIV-negative cohorts, there was significantly higher mortality in HIV-positive patients in earlier implant years, however, this association was not seen in later implant years (2018-2020). In both unmatched and matched cohorts, no significant differences in postimplantation stroke, major bleeding, or major infection were noted. CONCLUSIONS: With recent advancements in mechanical circulatory support and HIV treatment, ventricular assist device therapy is a viable therapeutic option for HIV-positive patients with end-stage heart failure.

Positive donor blood cultures are not associated with worse heart transplant survival.

BACKGROUND: Recent evidence has demonstrated that transplantation of hearts with blood culture positive donors (BCPDs) to pediatric recipients is safe and effective. Few studies have analyzed the effect of BCPD on adult heart transplant recipients. METHODS: The United Network for Organ Sharing (UNOS) database was retrospectively reviewed from September, 1987 to March, 2021. Exclusion criteria included pediatric donors/recipients, donor ejection fraction <10% or >85%, inactive listed recipients, donors missing blood cultures, and recipients missing follow-up time. Outcomes were compared with fully adjusted logistic models. To account for discrepancies in BCPD and non-BCPD covariates, an inverse proportionally weighted model with regression adjustment (IPWRA) was used. RESULTS: A total of 60 592 donors were non-BCPD, while 4009 were BCPD. 7% of hearts not transplanted were BCPD, while 6% of hearts transplanted were BCPD (p = .001). These rates have been nearly constant since 2005. There were no differences in short term survival between the two groups in the adjusted or IPWRA models (p = .103 and .277, respectively). Additionally, the BCPD group had longer ischemic time (3.24 vs. 3.06 h, p < .001), older donor age (32.73 vs. 31.65 years, p < .001), and older recipient age (52.76 vs. 52.09 years, p = .001). The IPWRA revealed an average additional 3.4 years of overall survival and 2.25 years of graft function for BCPD versus non-BCPD recipients, although these results failed to reach statistical significance (p = .387 and .527, respectively). CONCLUSIONS: Given the need for more donor hearts, donors with positive blood cultures should be considered. Great care in evaluating such patients is advised to eliminate donors with untreated infections, while carefully selected donors can be considered and used.