The challenge of advanced therapies in the contemporary era: first in Europe ECPELLA long-distance transfer-a case report.

Background: The use of mechanical circulatory support (MCS) has markedly increased over the last decade, so have the inter-hospital transfers, with the aim of being able to offer advanced heart failure (AHF) therapies and centralizing patients to tertiary centres. Case summary: In this article, we present the first in Europe long-distance air transfer of a patient supported by veno-arterial extracorporeal membrane oxygenator and Impella (ECPELLA), as a bridge to successful heart transplant. In our case report, a foreign young patient with AHF due to familiar cardiomyopathy required multiple MCS devices to achieve cardiovascular stability. After appropriate planning and multidisciplinary discussion, the patient was transferred on MCS to his country of origin via a fixed-wing airplane, in order to be assessed for heart transplantation. During take-off, the Impella flows temporarily dropped and a suction alarm was displayed; however, this rectified without intervention, and the rest of the flight was uneventful. One month after transfer, the patient underwent successful heart transplantation and remained clinically stable during the 12-month follow-up. Discussion: Our experience links together the current challenges in the evolving AHF strategies and the increased need for inter-facility cooperation. Both these clinical and logistic challenges appear to lead to possible improved outcomes, after appropriate assessment, training, and accurate planning. Our experience provides useful information on feasibility of long-distance transport of patients supported by ECPELLA in Europe.

Cardiac transplant rejection assessment with 18F-FDG PET-CT: initial single-centre experience for diagnosis and management.

BACKGROUND: Rejection is a major cause of mortality and morbidity in heart transplant (HTx) recipients. Current methods for diagnosing rejection have limitations. Imaging methods to map the entire left ventricle and reliably identify potential sites of rejection is lacking. Animal studies suggest FDG PET-CT (FDG PET) could have potential application in human HTx recipients. METHODS: Between December 2020 and February 2022, all HTx recipients at Harefield Hospital, London, with definite or suspected rejection underwent FDG PET in addition to routine work-up. RESULTS: Thirty HTx recipients (12 with definite and 18 with suspected rejection) underwent FDG PET scans. Overall, 12 of the 30 patients had FDG PET with increased myocardial avidity, of whom 2 died (17%). Eighteen patients of the 30 patients had FDG PET with no myocardial avidity and all are alive (100%, p = 0.15). All patients with definite rejection, scanned within 2 weeks of starting anti-rejection treatment, showed increased myocardial avidity. In 5 cases, FDG PET showed myocardial avidity beyond 6 weeks despite pulsed steroid treatment, suggesting unresolved myocardial rejection. CONCLUSION: Preliminary findings suggest FDG PET may have a role in diagnosing cardiac transplant rejection. Future blinded studies are needed to help further validate this.

Association of Renin-Angiotensin-Aldosterone System Inhibitors With Clinical Outcomes, Hemodynamics, and Myocardial Remodeling Among Patients With Advanced Heart Failure on Left Ventricular Assist Device Support.

BACKGROUND: We evaluated the potential benefits of renin-angiotensin-aldosterone system inhibitors (RAASi) in patients with left ventricular assist device support. METHODS AND RESULTS: A total of 165 consecutive patients undergoing left ventricular assist device implant and alive at 6-month on support were studied. RAASi status after 6-month visit along with clinical reasons for nonprescription/uptitration were retrospectively assessed. The primary outcome was a composite of heart failure hospitalization or cardiovascular death between 6 and 24 months after left ventricular assist device implant. Remodeling and hemodynamic outcomes were explored by studying the association of RAASi new prescription/uptitration versus unmodified therapy at 6-month visit with the change in echocardiographic parameters and hemodynamics between 6 and 18 months. After the 6-month visit, 76% of patients were on RAASi. Patients' characteristics among those receiving and not receiving RAASi were mostly similar. Of 85 (52%) patients without RAASi new prescription/uptitration at 6-month visit, 62% had no apparent clinical reason. RAASi were independently associated with the primary outcome (adjusted hazard ratio, 0.31 [95% CI, 0.16-0.69]). The baseline rates of optimal echocardiographic profile (neutral interventricular septum, mitral regurgitation less than mild, and aortic valve opening) and hemodynamic profile (cardiac index ≥2.2 L/min per m2, wedge pressure <18 mm Hg, and right atrial pressure <12 mm Hg) were similar between groups. At 18 months, patients receiving RAASi new prescription/uptitration at 6 months had higher rates of optimal hemodynamic profile (57.5% versus 37.0%; P=0.032) and trends for higher rates of optimal echocardiographic profile (39.6% versus 22.9%; P=0.055) compared with patients with 6-month unmodified therapy. Optimal 18-month hemodynamic and echocardiographic profiles were associated with the primary outcome (log-rank=0.022 and log-rank=0.035, respectively). CONCLUSIONS: RAASi are associated with improved outcomes and improved hemodynamics among mechanically unloaded patients.

Review of the allocation criteria for heart transplant in Spain in 2023. SEC-Heart Failure Association/ONT/SECCE consensus document.

Heart transplant (HT) remains the best therapeutic option for patients with advanced heart failure (HF). The allocation criteria aim to guarantee equitable access to HT and prioritize patients with a worse clinical status. To review the HT allocation criteria, the Heart Failure Association of the Spanish Society of Cardiology (HFA-SEC), the Spanish Society of Cardiovascular and Endovascular Surgery (SECCE) and the National Transplant Organization (ONT), organized a consensus conference involving adult and pediatric cardiologists, adult and pediatric cardiac surgeons, transplant coordinators from all over Spain, and physicians and nurses from the ONT. The aims of the consensus conference were as follows: a) to analyze the organization and management of patients with advanced HF and cardiogenic shock in Spain; b) to critically review heart allocation and priority criteria in other transplant organizations; c) to analyze the outcomes of patients listed and transplanted before and after the modification of the heart allocation criteria in 2017; and d) to propose new heart allocation criteria in Spain after an analysis of the available evidence and multidisciplinary discussion. In this article, by the HFA-SEC, SECCE and the ONT we present the results of the analysis performed in the consensus conference and the rationale for the new heart allocation criteria in Spain.

Bleeding and thrombotic complications and their impact on mortality in patients supported with left ventricular assist device for cardiogenic shock.

INTRODUCTION: Thrombosis and bleeding are major complications in patients supported with left ventricular assist devices (LVADs). We aimed to assess the incidence of bleeding and thrombosis in patients supported with a HeartWare left ventricular assist device (HVAD), their predictive factors and their impact on mortality. METHODS: A single centre retrospective observational study of patients supported with HVAD over 5 years from January 2015 to October 2020. RESULTS: A total 139 patients (median age 52.5, 72.1% male) were included for analysis. The probability of 1-year survival was 73.1%. Advanced age (>60 years) and EuroSCORE II score (>20%) were independently associated with reduced survival. Major bleeding and thrombosis occurred in 46.8% and 35.3% respectively. Secondary mechanical circulatory support (MCS) increased likelihood of experiencing major bleeding (HR: 2.76, 95%1.65-4.62, p < 0.0001) whilst patients receiving aspirin were protected from bleeding and thrombosis (HR: 0.34 95% CI 0.19-0.58, p < 0.001). Pre-operative anaemia (HR: 3.02, 95% CI: 1.6-5.7, p = 0.014) and use of a secondary MCS device (HR: 2.78, 95% CI: 1.2-6.3, p = 0.001) were associated with an increased risk of thrombosis. Patients with any major bleeding (with or without thrombosis) had a 7.68-fold (95% CI 3.5-16.8) increased risk of death compared to those without. In contrast, 'thrombosis only' patients had 4.23-fold (95% CI 1.8-10.2) increased risk of death compared to those without thrombosis. The risk of mortality was increased in patients with any thrombosis and the risk of death was highest in patients with major bleeding and thrombosis (HR: 16.49 [95% CI 7.7-35.3]). CONCLUSIONS: Major bleeding and thrombosis significantly increase the 1-year mortality. Optimal perioperative haemostasis and anticoagulation remains crucial in patients supported with HVAD.

Oral milrinone for management of refractory right ventricular failure in patients with left ventricular assist devices.

AIMS: We present a single-centre retrospective experience using oral milrinone in patients with a left ventricular assist device (LVAD) and concurrent refractory right ventricular failure. METHODS AND RESULTS: All patients implanted with LVAD between January 2013 and July 2021 from a high-volume advanced heart failure service were reviewed. Eight patients were initiated on oral milrinone during this period. Oral milrinone was started 1.5 [inter-quartile range (IQR) 1-2.3] years after LVAD implantation and continued for 1.2 (IQR 0.5-2.8) years. Therapeutic milrinone levels were achieved (232.2 ± 153.4 ng/mL) with 62.4 ± 18% of time within the therapeutic range. Two patients had adverse events (non-sustained ventricular tachycardia and ventricular fibrillation effectively treated by internal cardioverter defibrillator) but did not require milrinone discontinuation. Four deaths occurred, one after transplant and three from disease progression determined to be unrelated to oral milrinone use. Three patients continue oral milrinone therapy in the community. There was no significant difference found after the initiation of oral milrinone on any of the physiological measures; however, there were trends in reduction of New York Heart Association class from 3.4 ± 0.5 to 3.0 ± 0.8 (P = 0.08), reduction of right atrial/wedge pressure from 0.9 ± 0.3 to 0.5 ± 0.2 (P = 0.08), and improvement of right ventricular stroke work index from 3.8 ± 2 to 5.8 ± 2.7 (P = 0.16). CONCLUSIONS: Oral milrinone appears safe for long-term use in the outpatient setting when combined with therapeutic monitoring in this complex medical cohort with limited management options. Further study is needed to ascertain whether this treatment is effective in reducing heart failure symptoms and admissions.

Heart failure in adults with congenital heart disease.

Heart failure (HF) represents the leading cause of morbidity and mortality in adult patients with congenital heart disease. The nature of underlying congenital heart disease has bearing on timing and severity of HF and impacts on short- and long-term outcomes. HF can be subclinical, underscoring the need for close follow-up at tertiary centres with timely management of target hemodynamic lesions. Drug therapies have an effect in systemic left ventricle failure and are employed in acute HF for symptomatic relief. Data on elective drug therapy for the failing systemic right ventricle and/or Fontan circulation is currently lacking. Drugs such as angiotensin receptor blockers with neprilysin inhibitors or sodium-glucose co-transporter-2 inhibitors may show benefit. Cardiac resynchronization therapy, in appropriately selected patients, is considered a treatment option. Mechanical circulatory support and transplantation remain the last resource in highly selected patients. As the congenital heart disease population continues to grow and age, both outpatient and inpatient service for HF will continue to play a major role in the care of adult patients with congenital heart disease.

A detailed explantation assessment protocol for patients with left ventricular assist devices with myocardial recovery.

OBJECTIVES: Left ventricular assist device (LVAD) implantation for end-stage heart failure patients has been on the rise, providing a reliable long-term option. For some LVAD patients, longer term LV unloading leads to recovery; hence, the need for evaluating potential myocardial recovery and weaning eligibility has emerged. METHODS: All patients who underwent contemporary LVAD explantation at our institution between 2009 and 2020 were included in the study. Patients in New York Heart Association I, left ventricular ejection fraction >40%, a cardiac index >2.4 l/min and a peak oxygen intake >50% predicted underwent a 4-phase weaning assessment. A minimally invasive approach using a titanium plug was the surgery of choice in the most recent explants. Kaplan-Meier curves were used to estimate the survival at 1 and 5 years. RESULTS: Twenty-six patients (17 HeartMate II, 9 HeartWare) underwent LVAD explantation after a median 317 days of support [IQ (212-518)], range 131-1437. Mean age at explant was 35.8 ± 12.7 years and 85% were males. Idiopathic dilated cardiomyopathy was the underlying diagnosis in 70% of cases. Thirteen (48%) patients were on short-term mechanical circulatory support and 60% required intensive care unit admission prior to the LVAD implantation. At 1 year, Kaplan-Meier estimated survival was 88%, whereas at 6 years, it was 77%. The average left ventricular ejection fraction at 1 year post-explant was 44.25% ± 8.44. CONCLUSIONS: The use of a standardized weaning protocol (echocardiographic and invasive) and a minimally invasive LVAD explant technique minimizes periprocedural complications and leads to good long-term device-free survival rates.

Heart transplantation at a single tertiary adult congenital heart disease centre: Too little, too late?

BACKGROUND: Heart failure (HF) is the leading cause of death in adults with congenital heart disease (ACHD). Heart transplantation can be an effective therapy for them, albeit unfavourable anatomy, end-organ damage, pulmonary vascular disease, HLA sensitization and lack of robust selection criteria currently limit its application. METHODS: Consecutive CHD patients considered for heart or combined heart and lung transplantation at our tertiary ACHD centre between 2000 and 2018 constitute our study population. Baseline characteristics and outcome, including transplantation and death, were obtained for all patients from designated databases, medical records and the UK Office for National Statistics. RESULTS: From a total of more than 9000 active ACHD patients under follow-up, 166 (median age 40.4 years) fulfilled inclusion criteria, with a broad spectrum of underlying diagnosis: univentricular heart 22.3%, systemic right ventricle 22.3%, systemic-to-pulmonary shunts and Eisenmenger syndrome 16.3%, left sided valvular lesions 14.5%, tetralogy of Fallot 12.7%, CHD associated with cardiomyopathy 4.8% and other 7.2%. There was a high overall mortality with 39.2% of patients dying over a median follow-up of 2.7 years. A minority of patients (22.9%) were eventually listed and only 13.3% from the 166 patients were actually transplanted. Survival at 1 year after transplantation was 81.8% and remained high long-term (65.5% at 15 years). We describe herewith in detail characteristics and outcome of our cohort and present the transplantation pathway followed. CONCLUSION: Of the small number of patients with ACHD considered for heart transplantation at a large tertiary centre, there was high overall mortality, with only a fraction of patients being actually transplanted. Patients who received transplantation, however, had a good outcome. Better patient selection and timing are clearly warranted so that more ACHD patients are considered and potentially benefit from this effective form of therapy.

Cardiac tumors invading the right ventricle; Aggressive Surgical Management with backup mechanical circulatory support if necessary.

BACKGROUND: Primary cardiac tumors are exceedingly rare. Amongst the malignant types, sarcomas are the most frequently encountered. Treatment includes attempted aggressive surgical resection as the only curative option. We report our experience. METHODS: During the last five years, six patients presented at our institution with complex cardiac tumors with different underlying diagnoses and were at different stages of their disease. RESULTS: 6 patients with median age of 30-years-old underwent surgery in our centre. 3 patients had undergone debulking prior to surgery at our institution. In all patients, the tumor involved the right ventricle. One patient had biventricular involvement, the septum was involved in 4 patients, 2 patients had extracardiac growth, one invading both great vessels, one involving the pericardium and the hilar structures on the right side. Complete resection was achieved in 4 cases, 3 with successful resection-reconstruction, one with cardiectomy and implantation of a total artificial heart. 5 patients are currently alive, 4 free of recurrence. CONCLUSIONS: Complete radical surgery is the only curative treatment for patients suffering from cardiac tumors. The availability of mechanical circulatory support allows for a more radical surgical approach even including total cardiectomy, possibly resulting in a significant increase in R0 resections.

Clinical Indications of IMPELLA Short-Term Mechanical Circulatory Support in a Tertiary Centre.

INTRODUCTION: The Impella family of devices are short-term mechanical circulatory support (MCS) pumps that hold promise in treating patients with acute cardiogenic shock, acting as bridge to recovery, transplant or durable left ventricular assist device. We assessed the clinical utility, indications and outcomes of the Impella family of devices in a tertiary centre. METHODS: In the current study we present our initial 2-year experience with different Impella types. We explored the indications for device implantation, initial hemodynamic and biochemical response and mid-term survival. RESULTS: A total of 57 patients underwent Impella implantation; 36 Impella CP, 14 Impella 5.0 and 7 Impella RP. Mean age was 54.2 ±â€¯15.2 whereas 78.9% were males. The main indications for left sided MCS included cardiogenic shock secondary to ACS, decompensated dilated or ischemic end stage cardiomyopathy and myocarditis. Mean LVEF pre-Impella implantation was 23 ±â€¯13.7%. PCI was performed in 24 (54.5%) patients. Main indication for Impella RP was RV failure following LVAD implantation. The median duration of support was 5 days (IQR 1 to 10.5 days). 24 h following Impella implantation, there was significant improvement in all hemodynamic parameters as well as renal and liver function. Patients presenting with INTERMACS I had a 30-day survival of 40% whereas patients with INTEMACS 2 or above had a 30-day survival of 82.4%. CONCLUSIONS: The Impella short-term mechanical assist device provides immediate improvement in hemodynamic parameters and end organ function recovery. Patient outcomes are heavily influenced by the stage of shock and the timely insertion of MCS.

Surgical explant of a right ventricular assist device with sternum-sparing technique.

The use of long-term mechanical assist devices for isolated right ventricular failure is rare. Herein, we describe our protocol for successful recovery of the right ventricle and subsequent explantation of a right ventricular assist device using a sternum-sparing technique and insertion of a titanium plug to occlude the coring defect of the inflow cannula.