Background and aim: COVID-19 patients with severe heart or respiratory failure are potential candidates for extracorporeal membrane oxygenation (ECMO). Indications and management of these patients are unclear. Our aim is to describe the results of a prospective registry of COVID-19 patients treated with ECMO. Methods: An anonymous prospective registry of COVID-19 patients treated with veno-arterial (V-A) or veno-venous (V-V) ECMO was created on march 2020. Clinical, analytical and respiratory preimplantation variables, implantation data and post-implantation course data were recorded. The primary endpoint was all cause in-hospital mortality. Secondary events were functional recovery and the combined endpoint of mortality and functional recovery in patients followed at least 3 months after discharge. Results: Three hundred and sixty-six patients from 25 hospitals were analyzed, 347 V-V ECMO and 18 V-A ECMO patients (mean age 52.7 and 49.5 years respectively). Patients with V-V ECMO were more obese, had less frequently organ damage other than respiratory failure and needed less inotropic support; Thirty three percent of V-A ECMO and 34.9% of V-A ECMO were discharged (P = NS). Hospital mortality was non-significantly different, 56.2% versus 50.9% respectively, mainly during ECMO therapy and mostly due to multiorgan failure. Other 51 patients (14%) remained admitted. Mean follow-up was 196 +/- 101.7 days (95%CI: 170.8-221.6). After logistic regression, body weight (OR 0.967, 95%CI: 0.95-0.99, P = 0.004) and ECMO implantation in the own centre (OR 0.48, 95%CI: 0.27-0.88, P = 0.018) were protective for hospital mortality. Age (OR 1.063, 95%CI: 1.005-1.12, P = 0.032), arterial hypertension (3.593, 95%CI: 1.06-12.19, P = 0.04) and global (2.44, 95%CI: 0.27-0.88, P = 0.019), digestive (OR 4,23, 95%CI: 1.27-14.07, P = 0.019) and neurological (OR 4.66, 95%CI: 1.39-15.62, P = 0.013) complications during ECMO therapy were independent predictors of primary endpoint occurrence. Only the post-discharge day at follow-up was independent predictor of both secondary endpoints occurrence. Conclusions: Hospital survival of severely ill COVID-19 patients treated with ECMO is near 50%. Age, arterial hypertension and ECMO complications are predictors of hospital mortality, and body weight and implantation in the own centre are protective. Functional recovery is only predicted by the follow-up time after discharge. A more homogeneous management of these patients is warranted for clinical results and future research optimization. (C) 2022 Sociedad Espanola de Cirugia Cardiovascular y Endovascular. Published by Elsevier Espana, S.L.U.

Background: Current guidelines recommend emergency surgical correction in patients with post infarction ventricular septal rupture (PIVSR), but patients with multiorgan failure are commonly managed conservatively because of high surgical risk. We assessed characteristics and outcomes of operated PIVSR patients with or without the use of short-term ventricular assist devices (ST-VADs). We also assessed the impact of a ST-VAD on the performance of surgery Methods: We retrospectively analysed all consecutive patients with PIVSR between January 2004 and May 2017. Baseline clinical characteristics, use of ST-VAD and performance of surgery during admission were assessed. The main outcome measured was in-hospital mortality. Results: A total of 28 patients were included. Mean age was 69.2 years. Most patients (20/28, 71.4%) underwent surgical repair. ST-VADs were used in 11/28 patients (39.3%). This percentage progressively increased across the study period, from 22.2% (2/9) in 2004-2011 to 58.3% (7/12) in 2015-2017 (p=0.091). Patients undergoing ST-VAD use had poorer INTERMACS status, higher values of creatinine, lactate and alanine aminotransferase and lower left ventricular ejection fraction as compared with operated patients without support. In-hospital mortality did not differ according to the use of ST-VADs in operated patients (27.3% without ST-VAD vs. 22.2% with ST-VAD, p=0.604). All five patients undergoing early preoperative venoarterial extracorporeal membrane oxygenator support and delayed surgery survived at hospital discharge. Conclusions: ST-VAD use increased in patients with PIVSR. Despite a higher risk profile in operated patients undergoing ST-VAD use, mortality was not significantly different in these patients. Early preoperative venoarterial extracorporeal membrane oxygenation should be considered for very high risk PIVSR patients.

The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication.After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication.The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry.Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline.The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.

Platelet reactivity plays a role in the inflammatory process that favours graft vasculopathy and both Clopidogrel and Everolimus reduce platelet reactivity and graft vasculopathy in animal models. Our objective is to evaluate if, in heart transplant (HT) patients treated with clopidogrel, the use of Everolimus is associated with less platelet reactivity compared with treatment with Tacrolimus. We included 39 heart transplant patients treated with clopidogrel 75 mg, once daily. We compared platelet reactivity, using the vasodilator-stimulated phosphoprotein-P2Y12 Reactivity index (PRI), between 2 groups according to immunosuppressive treatment: 1) 20 patients with Everolimus and mycophenolate mofetil, 2) 19 patients with Tacrolimus and mycophenolate mofetil. We also compared them with 10 control patients treated with Clopidogrel but no immunosuppression. Data are expressed as least squares mean +/- standard error of mean (LSM±SEM) and analysis is performed using the general linear model. HT patients had a median of 67 years old and were a median of 8.8 years after HT. 74% males, 27% previous ischemic heart disease, 15% diabetics and 18% with graft vasculopathy. The median left ventricular ejection fraction was 62%. Median trough levels of the Everolimus group were 4.1 ng/mL and median trough levels of the tacrolimus group were 5.8 ng/mL. The PRI in the Everolimus group was 45.5±4.3%, in the Tacrolimus group of 40.4±4.8% and in the control group of 35.6±5.8%. There were no significant differences (see figure 1). PRI in patients with HT treated with Clopidogrel was not significantly different between patients treated with Everolimus and Tacrolimus. Patients with HT had a tendency to higher PRI compared to controls. The role of treatment with Clopidogrel in HT patients to prevent graft vasculopathy is still unclear.

Mammalian target of rapamycin (mTOR) inhibitors have well demonstrated immunosuppressive effects and their use in heart transplantation has been promoted in protocols of minimization or withdrawal of calcineurin inhibitors (CNI) in the context of renal insufficiency, cardiac allograft vasculopathy (CAV) and post-transplant malignancies1. However the use of m-TOR inhibitors is not free of adverse effects and discontinuation of m-TOR inhibitors ranges from 13 to 18% in randomized clinical trials2-4. A recent large, multicenter, observational study showed a discontinuation rate of 16% in the first year and 4% per year thereafter5. We aimed to assess long-term safety and tolerability of an m-TOR inhibitor-based regime in heart transplant recipients.

INTRODUCTION:The use of proliferation signal inhibitors (PSIs) for calcineurin-inhibitor (CNI) minimization or conversion protocols has been promoted for heart transplantation (HT) in the contexts of renal insufficiency, cardiac allograft vasculopathy (CAV), or malignancy. We evaluated our experience with conversion of patients from a CNI-based to a PSI-based immunosuppressive regimen. We focused on improvement in renal function. METHODS:This prospective follow-up included 96 HT patients converted to a PSI-based regimen from 2001 to 2010. We evaluated changes in creatinine clearance (CrCl) prior to at 1 year and at the end of follow-up after conversion. RESULTS:Ninety-six patients including 86% men showed a mean age of 62 ± 8 years. They were converted to a PSI-based regimen at 6.3 ± 4 years post-HT due to the following causes: CNI toxicity (45%), CAV (16%), cancer (16%), CNI toxicity + CAV (17%), or CNI toxicity + cancer (6%). CNI withdrawal was achieved in 77 cases (80%) and minimization in 19 (20%). Everolimus was used in 54 (56%) and sirolimus in 42 (44%) cases. Median follow-up time was 3.8 years. PSI discontinuation due to side effects was common (38%). There were 43 deaths mainly due to cancer and CAV. CrCl improved albeit not significantly in the withdrawal group from a median of 51 mL/min preconversion to 59 mL/min at the last follow-up (P = .12). In the minimization group, median CrCl worsened from a median of 61 mL/min preconversion to 51 mL/min at the last follow-up (P = .001). In the 58 cases (61%) of CNI nephrotoxicity, median CrCl improved from a median of 41 mL/min preconversion to 49 mL/min at the last follow-up (P = .04). CONCLUSION:Despite high rates of discontinuation of PSIs during long-term follow-up, the conversion regimen seemed to be useful to diminish CNI-related renal insufficiency especially with CNI withdrawal.

The safety and tolerability of mammalian target of rapamycin (m-TOR) inhibitors to reduce calcineurin inhibitors (CNI) induced toxicity and graft vasculopathy in cardiac transplant (CT) recipients over more than 2 years is currently unknown. We assessed the long-term safety and tolerability of an m-TOR inhibitor based regime in CT recipients.

El uso más frecuente de la asistencia circulatoria mecánica (ACM) es como puente al trasplante cardíaco, aunque va en aumento la intención de recuperación. Estudiamos nuestra experiencia y progreso en este último campo. Material y métodos: Desde 1992 hemos hecho 54 ACM (78% con Abiomed BVS), de las que 11 se destetaron con fracción de expulsión (FE) entre 35-55%, en 8 hombres y 3 mujeres, con 48 años de media. En nueve la ACM fue de duración corta (6,5 días) por shock cardiogénico, poscardiotomía (4 coronarios; 2 valvulares postinfarto agudo de miocardio [IAM] en 2 y un fallo primario postrasplante). En dos más, se retiró en una miocarditis post partum a los 42 días, con Abiomeds BVS y 5000, y en una miocardiopatía tóxica a los 135 días con una bomba implantable Incor. Resultados: Tres (27%) fallecieron en el hospital por infecciones y fallo multiorgánico. A largo plazo, uno lo hizo al año por paro cardiorrespiratorio, y otro a los quince por IAM. Los destetados a largo plazo también siguen bien, 0,7 y 2,6 años después. Conclusiones: La recuperación de la función ventricular con ACM es posible no sólo en fallos agudos, sino también a largo plazo en IAM, miocarditis y miocardiopatías dilatadas. Debemos ser prudentes antes de decidir un trasplante.

BACKGROUND:Toxic cardiomyopathies are rare and the most frequent cause are anthracycline compounds. Early acute toxicity can be reversible, but at present the only effective therapy for late end-stage anthracycline cardiomyopathy seems to be a heart transplantation. Currently, this transplantation is contraindicated in cases of cancer, at least during the first 4 or 5 years. Recently, implantable axial pumps have shown good results and are used with increasing frequency as destination therapy.METHODS:We present a case of end-stage heart failure due to a toxic cardiomyopathy after a bilateral breast cancer treated with resection and chemotherapy (doxorubicin and trastuzumab). Ejection fraction was 23% with dobutamine. A left ventricular axial pump (Incor) was implanted.RESULTS:The immediate postoperative course was uneventful. The left ventricular function improved and on the fourth month the ejection fraction was 55%. On postoperative day 135, the pump was explanted. After 1.5 years, the patient is doing well, with an ejection fraction of 57%.CONCLUSION:This is the first application of an implantable axial pump in Spain. Although toxic cardiomyopathies are rare, in cases of late end-stage left ventricular failure and when the heart transplantation is contraindicated, the implantation of an axial pump can be the solution. The results in previous cases are unknown, although it is possible, as in our case.

Objective. Heart transplantation (HT) due to valvular cardiornyopathy is rare, namely, about 3% of cases in the Registry of the International Society for Heart and Lung Transplantation (ISHLT). Usually, these patients present some risk factors such as previous valvular operations and pulmonary hypertension. Since there are few studies in the literature, we retrospectively analyzed our early and long-term results.Materials and Methods. We studied our experience in 22 HT cases for valvular cardiomyopathy (9.3% of our total experience), namely, 12 men and 10 women, of overall mean age of 52.6 +/- 1.0 years. Five patients had mitral; 8, aortic; and 1, tricuspid valve disease; 7 had double valve disease and 1, triple valve disease. Nineteen patients (87%) had been operated previously between 1 and 4 times. The mean ejection fraction was 23% +/- 7.3% and the mean New York Heart Association (NYHA) functional class was 3.7. Fifty-three percent of the patients had pulmonary hypertension. Two patients were operated as an emergency "O." We used the standard HT technique.Results. Four patients (18%) were reoperated due to hemorrhage. The hospital mortality was 2 cases (9%). Another patients (9%) died on follow-up due to cardiac allograft vasculopathy. All surviving patients have been followed to the end of 2006. The mean follow-up has been 72 +/- 53 months. They are functional class I or II.Conclusions. HT for this indication was more frequent in our experience than in the Registry of the ISHLT. The immediate and long-term results were good, with an 82% mean survival at 6 years. HT can be a good treatment for patients with valvular cardiornyopathy and bad ventricular function and/or multiple valvular reoperations.

Introduction. The mortality of cardiogenic shock (CS) after an acute myocardial infarction (AMI) still remains high. Thrombolysis, PTCA or CABG, when possible, can improve the results, but when all the treatments fail death is almost certain.Objective. We investigate the use of the mechanical circulatory assistance (MCA) and heart transplantation (HT) to improve the adverse results in this irreversible situation.Methods. Among 11 patients with irreversible CS after an AMI we used a MCA (Abiomed BVS-5000). After improvement and hemodynamic stabilization, we performed heart transplantation in 7 patients of mean age 52 years (35-60) including two women. The MCA was univentricular in 7 patients and biventricular in 4. Mean duration of the MCA was 5 days (1-12).Results. Three patients died during the MCA: two due to cerebrovascular accidents and one multiorgan failure. Weaning was possible in one patient. Among Seven transplanted patients one died due to sepsis. Seven (64%) patients are long-term survivors.Conclusion. When all the treatments have failed for CS after an AMI, MCA may be used as a bridge to heart transplantation in a select group of patients where the procedure is not contraindicated. The long-term results of 64% survivors in our experience is satisfactory.

AIMTo analyze the results of surgical treatment of left ventricular free wall rupture after acute myocardial infarct in a case series.METHODFrom 1984 to 2001, 25 patients (10 women and 15 men) were surgically treated in our Center for left ventricular free wall rupture after acute myocardial infarction. Their mean age was 62 years (range, 42-80). Cardiac symptoms (chest pain and/or dyspnea) prior to admission were recorded in 4 patients. One patient had acute myocardial infarction of the anterolateral wall, 6 patients of the lateral wall, 13 patients of the anterior wall, 4 patients of the inferior wall, and one patient had a right ventricle infarction. Thrombolytic therapy was administered in 10 patients, according to the criteria of the American Heart Association and Spanish Society of Cardiology criteria. In all patients, the final diagnosis was established echocardiographically before the surgery.RESULTSAll patients underwent surgical intervention on an emergency basis. Extracorporeal circulation was used in the first 9 cases, whereas the next 16 patients had off-pump surgery. Two patients had heart arrest during off-pump surgery, which required extracorporeal circulation support. One patient was found false positive for rupture only at surgery. In the first 4 cases, we performed a direct suture after excising necrotic tissue, in the next 15 cases we sutured a patch over the infarction zone, and in the last 5 patients we used Teflon patch fixed with fibrin glue and polypropylene and stitched to the epicardium with a continuous suture. Out of 24 patients, 8 died: one in the surgical room from uncontrollable bleeding and another 7 between 30 and 90 days after the surgery in the intensive care unit. All of them underwent surgery with extracorporeal circulation. There were no deaths among the patients undergoing off-pump surgery. Three out of 4 patients in whom direct suture and necrotic tissue excision was performed died in the hospital. Five out of 19 patients in whom patch correction with direct suture was done died in the hospital.CONCLUSIONThe left ventricle free wall rupture, as a complication of acute myocardial infarction, can be diagnosed early and treated on time. Rapid diagnosis and emergency surgery are crucial for successful treatment of patients with impending heart rupture. Off-pump surgery and patch with glue technique seem to yield best results.

We present the case of a patient with vegetations on a pacing lead from a pacemaker implanted 13 years previously. A new surgical technique for removal of infected leads was developed to avoid the increased risk of septic pulmonary embolism. The electrode with vegetations was removed without cardiopulmonary bypass using the direct surgical approach described.