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INTRODUCTION: Insufficient supply of cardiac grafts represents a severe obstacle in heart transplantation. Donation after Circulatory Death (DCD), in addition to conventional donation after brain death, is one promising option to overcome the organ shortage. However, DCD organs undergo an inevitable more extended period of warm unprotected ischemia between circulatory arrest and graft procurement. Mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs) have shown remarkable protective effects against ischemia-reperfusion injury. Thus, we aimed to enhance grafts preservation from DCD donors, through treatment with MSC-EVs. METHODS: Female pigs were euthanized by barbiturate overdose and after 20â¯min of a flat EKG, the chest was opened, the heart harvested and subsequently connected to an extracorporeal perfusion machine. MSC-EVs, isolated by ion exchange chromatography, were added to the perfusion solution (1×1011 particles) and the heart was perfused for 2â¯h. Then, heart tissue biopsies were taken to assess histological changes, mitochondrial morphology, antioxidant enzyme activity and inflammation mediators' expression. Biochemical parameters of myocardial viability were assessed in the perfusate. RESULTS: The treatment with MSC-EVs significantly prevented mitochondria swelling, mitochondrial cristae loss and oxidative stress in cardiac tissue. The protective effect of MSC-EVs was confirmed by the delayed increase of the cardiac-specific enzymes CK and TnC in the perfusate and the reduction of caspase-3+ cells in tissue sections. CONCLUSION: MSC-EVs improve graft quality by preserving the mitochondrial ultrastructure protecting the myocardium against oxidative stress, reducing apoptosis of cardiac cells and preventing the increase of pro-inflammatory cytokines.
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BACKGROUND: Static cold storage (SCS) remains the gold standard for preserving donor hearts before transplantation but is associated with ischaemia, anaerobic metabolism, and organ injuries, leading to patient morbidity and mortality. We aimed to evaluate whether continuous, hypothermic oxygenated machine perfusion (HOPE) of the donor heart is safe and superior compared with SCS. METHODS: We performed a multinational, multicentre, randomised, controlled, open-label clinical trial with a superiority design at 15 transplant centres across eight European countries. Adult candidates for heart transplantation were eligible and randomly assigned in a 1:1 ratio. Donor inclusion criteria were age 18-70 years with no previous sternotomy and donation after brain death. In the treatment group, the preservation protocol involved the use of a portable machine perfusion system ensuring HOPE of the resting donor heart. The donor hearts in the control group underwent ischaemic SCS according to standard practices. The primary outcome was time to first event of a composite of either cardiac-related death, moderate or severe primary graft dysfunction (PGD) of the left ventricle, PGD of the right ventricle, acute cellular rejection at least grade 2R, or graft failure (with use of mechanical circulatory support or re-transplantation) within 30 days after transplantation. We included all patients who were randomly assigned, fulfilled inclusion and exclusion criteria, and received a transplant in the primary analysis and all patients who were randomly assigned and received a transplant in the safety analyses. This trial was registered with ClicalTrials.gov (NCT03991923) and is ongoing. FINDINGS: A total of 229 patients were enrolled between Nov 25, 2020, and May 19, 2023. The primary analysis population included 204 patients who received a transplant. There were no patients who received a transplant lost to follow-up. All 100 donor hearts preserved with HOPE were transplantable after perfusion. The primary endpoint was registered in 19 (19%) of 101 patients in the HOPE group and 31 (30%) of 103 patients in the SCS group, corresponding to a risk reduction of 44% (hazard ratio 0·56; 95% CI 0·32-0·99; log-rank test p=0·059). PGD was the primary outcome event in 11 (11%) patients in the HOPE group and 29 (28%) in the SCS group (risk ratio 0·39; 95% CI 0·20-0·73). In the HOPE group, 63 (65%) patients had a reported serious adverse event (158 events) versus 87 (70%; 222 events) in the SCS group. Major adverse cardiac transplant events were reported in 18 (18%) and 33 (32%) patients in the HOPE and SCS group (risk ratio 0·56; 95% CI 0·34-0·92). INTERPRETATION: Although there was not a significant difference in the primary endpoint, the 44% risk reduction associated with HOPE was suggested to be a clinically meaningful benefit. Post-transplant complications, measured as major adverse cardiac transplant events, were reduced. Analysis of secondary outcomes suggested that HOPE was beneficial in reducing primary graft dysfunction. HOPE in donor heart preservation addresses the existing challenges associated with graft preservation and the increasing complexity of donors and heart transplantation recipients. Future investigation will help to further elucidate the benefit of HOPE. FUNDING: XVIVO Perfusion.
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Trasplante de Corazón , Preservación de Órganos , Perfusión , Humanos , Persona de Mediana Edad , Masculino , Femenino , Preservación de Órganos/métodos , Adulto , Perfusión/métodos , Anciano , Disfunción Primaria del Injerto/prevención & control , Adulto Joven , Donantes de Tejidos , Adolescente , Resultado del Tratamiento , Rechazo de Injerto/prevención & controlRESUMEN
Due to the discrepancy between patients awaiting a heart transplant and the availability of donor hearts, strategies to expand the donor pool and improve the transplant's success are crucial. This review aims to summarize current knowledge on the ex vivo heart preservation (EVHP) experience as an alternative to standard cold static storage (CSS). EVHP techniques can improve the preservation of the donor's heart before transplantation and allow for pre-transplant organ evaluation.
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Trasplante de Corazón , Preservación de Órganos , Perfusión , Humanos , Trasplante de Corazón/métodos , Preservación de Órganos/métodos , Perfusión/métodos , Donantes de TejidosRESUMEN
Even if the Fontan operation is the surgical treatment of choice in patients with univentricular physiology, it remains a palliative strategy. Consequently, when Fontan patients reach adulthood, the majority of them develop late clinical sequelae of a failing cavo-pulmonary circuit (eg, liver failure, protein-losing enteropathy, and arrhythmias). Although heart transplantation represents the gold standard to treat this condition, Fontan patients usually accede to this therapy late, when risk of mortality is significantly increased, and a shortage of donor hearts limits transplantation in this special population. Mechanical circulatory support is an emerging field, but it is still in the experimental stage. Current mechanical circulatory devices have been used in Fontan circulation but are associated with the need for high-risk redo surgery. Percutaneous pumps are an emerging field that is still under investigation, with multiple prototypes developed. This review aims to analyze the hemodynamic profile of the developed intravascular pumps and their application in the preclinical scenario in the Fontan circulation.
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AIMS: Transvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes. METHODS AND RESULTS: In 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035). CONCLUSION: Significant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.
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Desfibriladores Implantables , Remoción de Dispositivos , Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/etiología , Masculino , Femenino , Remoción de Dispositivos/efectos adversos , Anciano , Persona de Mediana Edad , Desfibriladores Implantables/efectos adversos , Anciano de 80 o más Años , Índice de Severidad de la Enfermedad , Factores de Riesgo , Resultado del Tratamiento , Marcapaso Artificial/efectos adversos , Estudios Retrospectivos , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Válvula Tricúspide/fisiopatología , Factores de TiempoRESUMEN
BACKGROUND: Cardiac allograft vasculopathy (CAV) assessment post-heart transplantation (HT) typically relies on invasive coronary angiography (ICA). However, cardiac computed tomography angiography (CCTA) is emerging as a promising alternative due to its potential benefits in economic, safety, and logistical aspects. This study aimed to evaluate the impact of a CCTA program on these aspects in CAV surveillance post-HT. METHODS: A retrospective single-center study was conducted between March 2021 and February 2023, involving HT patients who underwent either CCTA or ICA. RESULTS: Among 260 patients undergoing CAV surveillance, 115 (44.2%) patients underwent CCTA, and 145 (55.8%) patients underwent ICA. The CCTA group showed incurred lower overall costs (p â< â0.0001) and shorter hospitalization times (p â< â0.0001) compared to the ICA group. In terms of safety, CCTA surveillance required significantly lower contrast volumes (p â< â0.0001) and lower effective doses (p â= â0.03). CONCLUSION: CCTA emerges as a safe and cost-effective non-invasive alternative for CAV surveillance post-HT, outperforming ICA in terms of safety, logistical aspects, and economic burden.
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INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.
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Análisis Costo-Beneficio , Oxigenación por Membrana Extracorpórea , Corazón Auxiliar , Choque Cardiogénico , Humanos , Choque Cardiogénico/terapia , Choque Cardiogénico/economía , Oxigenación por Membrana Extracorpórea/economía , Oxigenación por Membrana Extracorpórea/métodos , Corazón Auxiliar/economía , Estudios Prospectivos , Estudios Retrospectivos , Italia , Calidad de Vida , Estudios Multicéntricos como Asunto , Presupuestos , Estudios Observacionales como AsuntoRESUMEN
Current guidelines for the care of heart transplantation recipients recommend routine endomyocardial biopsy and invasive coronary angiography as the cornerstones in the surveillance for acute rejection (AR) and coronary allograft vasculopathy (CAV). Non-invasive tools, including coronary computed tomography angiography and cardiac magnetic resonance, have been introduced into guidelines without roles of their own as gold standards. These techniques also carry the risk of contrast-related kidney injury. There is a need to explore non-invasive approaches providing valuable information while minimizing risks and allowing their application independently of patient comorbidities. Echocardiographic examination can be performed at bedside, serially repeated, and does not carry the burden of contrast-related kidney injury and procedure-related risk. It provides comprehensive assessment of cardiac morphology and function. Advanced echocardiography techniques, including Doppler tissue imaging and strain imaging, may be sensitive tools for the detection of minor myocardial dysfunction, thus providing insight into early detection of AR and CAV. Stress echocardiography may offer a valuable tool in the detection of CAV, while the assessment of coronary flow reserve can unravel coronary microvascular impairment and add prognostic value to conventional stress echocardiography. The review highlights the role of Doppler echocardiography in heart transplantation follow-up, weighting advantages and limitations of the different techniques.
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Background and Objectives: Determinants of long-term outcomes after surgery for native mitral valve endocarditis have not been thoroughly investigated. The aim of this study was to assess anatomical, disease, and surgical risk factors for long-term mortality and need of reintervention, in patients undergoing mitral valve surgery for active endocarditis. Materials and Methods: Patients who underwent surgery for active native mitral valve endocarditis at three academic centres, between 2000 and 2022, were analysed. The primary outcome was long-term survival. The secondary outcome was the freedom from mitral reoperation. Survival curves were constructed with Kaplan-Meier methodology. Multivariable Cox regression was used to identify demographic, anatomical, disease, and surgical factors associated with late mortality and reoperation. Results: 335 consecutive patients with active mitral endocarditis were analysed. Two hundred and one patients (70.5%) had infection confined to the valve cusp whereas 89 (25.6%) had invasive disease extended to the annulus and surrounding tissues. Preoperative neurological events occurred at the diagnosis in 52 cases. Streptococci were the most common causative organisms followed by Staphylococcus aureus, Coagulase-negative Staphylococcus, and Enterococcus. Valve repair was performed in 108 patients (32.2%). Survival at 5 and 10 years was 70.1% and 59.2%, respectively. Staphylococcus emerged as an independent predictor of late mortality, along with age, chronic obstructive pulmonary disease, and previous cardiac surgery. Survival was considerably reduced in patients with S. aureus compared with those without (log rank p < 0.001). The type of surgery (repair vs. replacement) did not emerge as a risk factor for late mortality and reoperation. Seventeen patients underwent mitral reoperation during the follow-up. The 5- and 10-year freedom from reoperation was 94.7% and 91.8%, respectively. Conclusions: Active mitral valve endocarditis remains a life-threatening disease with impaired survival. While lesion characteristics influenced surgical decision-making and intraoperative management, their impact on long-term survival and freedom from reintervention appears to be moderated by other factors such as infecting pathogens and patient comorbidities.
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Válvula Mitral , Humanos , Femenino , Masculino , Persona de Mediana Edad , Válvula Mitral/cirugía , Anciano , Reoperación/estadística & datos numéricos , Factores de Riesgo , Resultado del Tratamiento , Estudios Retrospectivos , Endocarditis/cirugía , Endocarditis/mortalidad , Adulto , Modelos de Riesgos Proporcionales , Estimación de Kaplan-MeierRESUMEN
BACKGROUND: Withdrawal of life-sustaining therapy (WLST) performed in the circulatory determination of death (DCD) donors leads to cardiac arrest, challenging the utilization of the myocardium for transplantation. The rapid initiation of normothermic regional perfusion or extracorporeal membrane oxygenation after death helps to optimize organs before implantation. However, additional strategies to mitigate the effects of stress response during WLST, hypoxic/ischemic injury, and reperfusion injury are required to allow myocardium recovery. METHODS: To this aim, our team routinely used a preconditioning protocol for each DCD donation before and during the WLST and after normothermic regional perfusion/extracorporeal membrane oxygenation. The protocol includes pharmacological treatments combined to reduce oxidative stress (melatonin, N -acetylcysteine, and ascorbic acid), improve microcirculation (statins), and mitigate organ's ischemic injury (steroids) and organ ischemia/reperfusion injury (remifentanil and sevoflurane when the heart is available for transplantation). RESULTS: This report presents the first case of recovery of cardiac function, with the only support of normothermic regional reperfusion, following 20 min of a no-touch period and 41 min of functional warm ischemic time in a DCD donor after the preconditioning protocol. CONCLUSIONS: Our protocol seems to be effective in abolishing the stress response during WLST and, on the other hand, particularly organ protective (and heart protective), giving a chance to donate organs less impaired from ischemia/reperfusion injury.
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Oxigenación por Membrana Extracorpórea , Recuperación de la Función , Humanos , Masculino , Donantes de Tejidos , Trasplante de Corazón , Factores de Tiempo , Perfusión/métodos , Resultado del Tratamiento , Estrés Oxidativo , Muerte , Persona de Mediana Edad , Adulto , Isquemia Tibia/efectos adversosRESUMEN
The production of biomedical devices able to appropriately interact with the biological environment is still a great challenge. Synthetic materials are often employed, but they fail to replicate the biological and functional properties of native tissues, leading to a variety of adverse effects. Several commercial products are based on chemically treated xenogeneic tissues: their principal drawback is due to weak mechanical stability and low durability. Recently, decellularization has been proposed to bypass the drawbacks of both synthetic and biological materials. Acellular materials can integrate with host tissues avoiding/mitigating any foreign body response, but they often lack sufficient patency and impermeability. The present paper investigates an innovative approach to the realization of hybrid materials that combine decellularized bovine pericardium with polycarbonate urethanes. These hybrid materials benefit from the superior biocompatibility of the biological tissue and the mechanical properties of the synthetic polymers. They were assessed from physicochemical, structural, mechanical, and biological points of view; their ability to promote cell growth was also investigated. The decellularized pericardium and the polymer appeared to well adhere to each other, and the two sides were distinguishable. The maximum elongation of hybrid materials was mainly affected by the pericardium, which allows for lower elongation than the polymer; this latter, in turn, influenced the maximum strength achieved. The results confirmed the promising features of hybrid materials for the production of vascular grafts able to be repopulated by circulating cells, thus, improving blood compatibility.
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Background: Heart failure (HF)-related mortality has been exacerbated by the COVID-19 pandemic; however, it is unclear how healthcare reassessment has contributed to the excess mortality versus SARS-CoV-2 infection itself. We aimed to assess how the pandemic affected the therapeutic management and prognosis of HF patients. Methods: We retrospectively reviewed the healthcare utilization databases of the Lombardy region (Italy) to identify all newly-diagnosed HF patients from January 2018 to December 2021. Outcomes were the utilization of HF therapies (Sacubitril/Valsartan; cardiac resynchronization therapy [CRT] and/or implantable cardioverter-defibrillator [ICD]; mechanical circulatory support [MCS]; heart transplantation [HTX]) and mortality. Cox regression models were fitted to estimate the hazard ratios (HR) and 95% confidence intervals (CI) for outcomes associated with the pandemic. Results: 36,130 and 17,263 patients were identified in the pre-pandemic and pandemic eras, respectively. The pandemic reduced Sacubitril/Valsartan utilization (HR = 0.77, 95% CI: 0.65-0.91) and CRT/ICD implantation (HR = 0.85, 95% CI: 0.78-0.92), but not MCS (HR = 1.11, 95% CI: 0.86-1.43) and HTX (HR = 0.88, 95% CI: 0.70-1.09). An increased mortality risk was observed during the pandemic (HR = 1.19, 95% CI: 1.15-1.23), which was attributable to SARS-CoV-2 infection (HR for non-COVID-19-related mortality = 1.01, 95% CI: 0.97-1.04). Conclusions: The COVID-19 pandemic was associated with a reduction in medical and interventional therapies for HF and an increase in mortality for HF patients.
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Endovascular aortic arch repair (Ar-TEVAR) with single-branch, off-the-shelf Nexus aortic arch system has shown promising early and 3-year outcomes. There is lack of data regarding long-term results of this specific device, particularly regarding patency of supra-aortic bypasses and stability of the connection between the 2 modules. This case report describes 6-year clinical and imaging follow-up of a 74-year-old patient who underwent Ar-TEVAR with Nexus. Over 6 years, the patient experienced minor complications unrelated to the device. The patency of supra-aortic bypasses and integrity of the device's connection were confirmed. Computed tomography angiography constantly showed exclusion of the aneurysm and reduction of the aneurysmal sac. In conclusion, although extended research and broader data are needed, this case provides encouraging evidence of long-term results of Ar-TEVAR with Nexus.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Anciano , Prótesis Vascular , Angiografía por Tomografía Computarizada , Implantación de Prótesis Vascular/métodos , Stents , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Estudios de Seguimiento , Resultado del Tratamiento , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Estudios RetrospectivosRESUMEN
A 45 year old male obese patient with a previous history of repaired congenital heart disease developed worsening heart failure making heart transplantation listing mandatory. Unfortunately, due to his anthropometric measures, the search for a suitable brain-dead donor was unsuccessful. For this reason, he accepted to be enrolled in the controlled donation after circulatory death (cDCD) program. According to the Italian Law regulating death declaration after cardiac arrest (no-touch period of 20 minutes-one of the longest in the world), we faced a 34 minute cardiac asystole, after which the heart was recovered through a thoraco-abdominal normothermic regional perfusion excluding the epiaortic vessels. The heart was then preserved by means of cold static storage. Heart transplantation was performed successfully without any signs of primary graft failure. Postoperative endomyocardial biopsies were negative for acute cellular and antibody-mediated rejection. Furthermore, echocardiographic and cardiac magnetic resonance evaluation of the heart did not show any functional abnormalities. The patient was discharged on post-operative day (POD) #39 in good clinical conditions.
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Trasplante de Corazón , Isquemia Tibia , Humanos , Masculino , Trasplante de Corazón/efectos adversos , Trasplante de Corazón/métodos , Persona de Mediana Edad , Isquemia Tibia/efectos adversos , Isquemia Tibia/métodos , Italia , Donantes de Tejidos , Obtención de Tejidos y Órganos/métodos , Preservación de Órganos/métodosRESUMEN
Patients with aortic arch pathologies after surgery for type-A acute aortic dissection represent a challenging population since open surgery is associated with a non-negligible rate of mortality and complications. Microinvasive endovascular aortic arch repair Arch-Thoracic EndoVascular Aortic Repair (Ar-TEVAR) has shown promising results in high-risk patients. Ar-TEVAR is usually performed under general anaesthesia. We report the case of an 83-year-old man with a history of ascending aorta replacement for type-A acute aortic dissection who was referred for an anastomotic pseudoaneurysm. Ar-TEVAR using an off-the-shelf single-branch aortic arch stent graft was chosen. In order to further minimize procedural invasiveness, monitored anaesthesia care (local anaesthesia with sedation and analgesia) was performed since it provides less stress on the cardiovascular and respiratory systems and overall leads to a faster recovery especially in elderly patients.
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Anestesia , Aneurisma de la Aorta Torácica , Disección Aórtica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Aorta Torácica/cirugía , Prótesis Vascular , Reparación Endovascular de Aneurismas , Aneurisma de la Aorta Torácica/cirugía , Stents , Resultado del Tratamiento , Disección Aórtica/cirugía , Estudios RetrospectivosRESUMEN
Vein grafts are the most used conduits in coronary artery bypass grafting (CABG), even though many studies have suggested their lower patency compared to arterial alternatives. We have reviewed the techniques and technologies that have been investigated over the years with the aim of improving the quality of these conduits. We found that preoperative and postoperative optimal medical therapy and no-touch harvesting techniques have the strongest evidence for optimizing vein graft patency. On the other hand, the use of venous external support, endoscopic harvesting, vein preservation solution and anastomosis, and graft configuration need further investigation. We have also analyzed strategies to treat vein graft failure: when feasible, re-doing the CABG and native vessel primary coronary intervention (PCI) are the best options, followed by percutaneous procedures targeting the failed grafts.
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Procedimientos Quirúrgicos Cardíacos , Intervención Coronaria Percutánea , Puente de Arteria Coronaria , Corazón , TecnologíaRESUMEN
OBJECTIVES: In the last decades, 4 different scores for the prediction of mortality following surgery for type A acute aortic dissection (TAAD) were proposed. We aimed to validate these scores in a large external multicentre cohort. METHODS: We retrospectively analysed patients who underwent surgery for TAAD between 2000 and 2020. Patients were enrolled from 10 centres from 2 European countries. Outcomes were the early (30-day and/or in-hospital) and 1-year mortality. Discrimination, calibration and observed/expected (O/E) ratio were evaluated. RESULTS: A total of 1895 patients (31.7% females, mean age 63.72 ± 12.8 years) were included in the study. Thirty-day mortality and in-hospital mortality were 21.7% (n = 412) and 22.5% (n = 427) respectively. The German Registry of Acute Aortic Dissection Type A (GERAADA) score shows to have the best discrimination [area under the curve (AUC) 0.671 and 0.672] in predicting as well the early and the 1-year mortality, followed by the International Registry of Acute Aortic Dissection (IRAD) model 1 (AUC 0.658 and 0.672), the Centofanti (AUC 0.645 and 0.66) and the UK aortic score (AUC 0.549 and 0.563). According to Hosmer-Lemeshow and Brier tests, the IRAD model I and GERAADA, respectively, were well calibrated for the early mortality, while the GERAADA and Centofanti for the 1-year mortality. The O/E analysis showed a marked underestimation for patients labelled as low-risk for UK aortic score and IRAD model I for both outcomes. CONCLUSIONS: The GERAADA score showed the best performance in comparison with other scores. However, none of them achieved together a fair discrimination and a good calibration for predicting either the early or the 1-year mortality.
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Disección Aórtica , Azidas , Desoxiglucosa/análogos & derivados , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Estudios Retrospectivos , Disección Aórtica/cirugía , Mortalidad Hospitalaria , Europa (Continente) , Sistema de Registros , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure (HF). Subcutaneous implantable cardioverter defibrillator (S-ICD) might be a viable alternative to conventional ICDs with a lower risk of short- and long-term of device-related complications and infections.The aim of this multicenter study was to evaluate the outcomes and management of S-ICD recipients who underwent LVAD implantation. METHODS: The study population included patients with a preexisting S-ICD who underwent LVAD implantation for advanced HF despite optimal medical therapy. RESULTS: The study population included 30 patients (25 male; median age 45 [38-52] years).The HeartMate III was the most common LVAD type. Median follow-up in the setting of concomitant use of S-ICDs and LVADs was 7 months (1-20).There were no reports of inability to interrogate S-ICD systems in this population. Electromagnetic interference (EMI) occurred in 21 (70%) patients. The primary sensing vector was the one most significantly involved in determining EMI. Twenty-seven patients (90%) remained eligible for S-ICD implantation with at least one optimal sensing vector. The remaining 3 patients (10%) were ineligible for S-ICD after attempts of reprogramming of sensing vectors. Six patients (20%) experienced inappropriate shocks (IS) due to EMI. Six patients (20%) experienced appropriate shocks. No S-ICD extraction because of need for antitachycardia pacing, ineffective therapy or infection was reported. CONCLUSIONS: Concomitant use of LVAD and S-ICD is feasible in most patients. However, the potential risk of EMI oversensing, IS and undersensing in the post-operative period following LVAD implantation should be considered. Careful screening for EMI should be performed in all sensing vectors after LVAD implantation.
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Desfibriladores Implantables , Insuficiencia Cardíaca , Corazón Auxiliar , Marcapaso Artificial , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Desfibriladores Implantables/efectos adversos , Cardioversión Eléctrica/efectos adversos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/complicaciones , Corazón Auxiliar/efectos adversos , Marcapaso Artificial/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: The Medtronic SelectSecure Model 3830 lumenless lead (Medtronic, Inc., Minneapolis, MN) is commonly used for conduction system pacing (CSP). However, with this increased use, the potential need for transvenous lead extraction (TLE) also will increase. While extraction of endocardial 3830 leads is rather well described especially in pediatric and adult congenital heart disease population, there is very limited data on extraction of CSP leads. In the present study, we reported our preliminary experience on TLE of CSP leads and provided technical considerations. METHODS: The study population comprised 6 consecutive patients (67% male; mean age 70 ± 22 years) with CSP leads (3830 leads), including left bundle branch pacing (LBBP) lead (n = 3) and His pacing lead (n = 3) undergoing TLE. Overall target leads were 17. The mean implant duration time of CSP leads was 97 ± 90 months [range 8-193). RESULTS: Manual traction was successful in 2 cases and mechanical extraction tools were required in the remaining cases. Sixteen leads (94%) were completely extracted, whereas incomplete removal was observed in one lead (6%) among 1 patient. Of note, in the only lead incompletely removed, we observed retention of < 1-cm remnant of lead material consisting of the screw of 3830 LBBP lead into the interventricular septum. No failure of lead extraction was reported and no major complications occurred. CONCLUSIONS: Our findings demonstrated that at an experienced center the success of TLE of chronically implanted CSP leads is high in the absence of major complications also when mechanical extraction tools are needed.