Five-year results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement-the ARISE Study and ARISE Registry Data.

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement for young patients. METHODS: A prospective, EU-funded, single-arm, multicentre study in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: A total of 144 patients (99 male) were prospectively enrolled in the ARISE Trial between October 2015 and October 2018 with a median age of 30.4 years [interquartile range (IQR) 15.9-55.1]; 45% had undergone previous cardiac operations, with 19% having 2 or more previous procedures. The mean implanted DAH diameter was 22.6 mm (standard deviation 2.4). The median operation duration was 312 min (IQR 234-417), the median cardiopulmonary bypass time was 154 min (IQR 118-212) and the median cross-clamp time 121 min (IQR 93-150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, 1 due to a LCA thrombus on day 3 and 1 due ventricular arrhythmia 5 h postoperation. There were 3 late deaths, 1 death due to endocarditis 4 months postoperatively and 2 unrelated deaths after 5 and 7 years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9 years [IQR 5.1-6.4, mean 5.5 years. (standard deviation 1.3) max. 7.6 years], the primary efficacy end-points peak gradient with median 11.0 mmHg (IQR 7.8-17.6) and regurgitation of median 0.5 (IQR 0-0.5) of grade 0-3 were excellent. At 5 years, freedom from death/reoperation/endocarditis/bleeding/thromboembolism were 97.9%/93.5%/96.4%/99.2%/99.3%, respectively. CONCLUSIONS: The 5-year results of the prospective multicentre ARISE trial continue to show DAH to be safe for aortic valve replacement with excellent haemodynamics.

Repair of mitral prolapse: comparison of thoracoscopic minimally invasive and conventional approaches.

OBJECTIVES: Surgical repair remains the best treatment for severe primary mitral regurgitation (MR). Minimally invasive mitral valve surgery is being increasingly performed, but there is a lack of solid evidence comparing thoracoscopic with conventional surgery. Our objective was to compare outcomes of both approaches for repair of leaflet prolapse. METHODS: All consecutive patients undergoing surgery for severe MR due to mitral prolapse from 2012 to 2020 were evaluated according to the approach used. Freedom from mortality, reoperation and recurrent severe MR were evaluated by Kaplan-Meier method. Differences in baseline characteristics were adjusted with propensity score-matched analysis (1:1, nearest neighbour). RESULTS: Three hundred patients met inclusion criteria and were divided into thoracoscopic (N = 188) and conventional (sternotomy; N = 112) groups. Unmatched patients in the thoracoscopic group were younger and had lower body mass index, New York Heart Association class and EuroSCORE II preoperatively. After matching, thoracoscopic group presented significantly shorter mechanical ventilation (9 vs 15 h), shorter intensive care unit stay (41 vs 65 h) and higher postoperative haemoglobin levels (11 vs 10.2 mg/dl) despite longer bypass and cross-clamp times (+30 and +17 min). There were no differences in mortality or MR grade at discharge between groups nor differences in survival, repair failures and reinterventions during follow-up. CONCLUSIONS: Minimally invasive mitral repair can be performed in the majority of patients with mitral prolapse, without compromising outcomes, repair rate or durability, while providing shorter mechanical ventilation and intensive care unit stay and less blood loss.

Functional mitral regurgitation.

Dr. O.P. Yadava, Editor-in-Chief, IJTC, and Dr. J.L. Pomar, Former President, EACTS, discuss issues related to secondary mitral regurgitation (MR). Though it is considered a ventricular disease, mitral valve leaflets are not entirely normal. Alignment of subvalvular apparatus plays a more dominant role than annular dilatation. Early repair is preferred.

Registry of Valvular and Vascular Allograft Transplants in the Autonomous Community of Catalonia, Spain (ReVAC): Design of the Registry.

BACKGROUND: In recent years, there have been significant changes in the perception of valvular and vascular allograft transplants. Despite the constant evolution of the field of transplant and the involvement of multiple surgical specialties, there is not an official registry for administrative and clinical control. This study aims to design a registry of vascular and valvular allograft transplantation in Catalonia, Spain (ReVAC). MATERIALS AND METHODS: Three consecutive focal groups were designed. Focal groups established administrative, technical, and clinical requirements of ReVAC. ReVAC included patients with a transplanted cryopreserved vascular segment or cardiac valves that were distributed by Catalan tissue banks to public and private hospitals in Catalonia. Ten hospitals were involved in this study. Data were collected on 380 patients between January 1995 and November 2015. RESULTS: The project resulted in the completion of a growing platform available online. ReVAC was divided into the following 3 levels: patient-related, surgery-related, and transplant-related data. Online access is available through the website of applications of the "Generalitat de Catalunya." CONCLUSION: ReVAC has been useful for administrative and clinical control of transplants in Catalonia. Currently, data related to outcomes of arterial allografts are available, reinforcing the current guideline-supported indications, as well as opening a window for further analysis and guideline creation.

Cryopreserved Allografts for Treatment of Chronic Limb-Threatening Ischemia in Patients Without Autologous Saphenous Veins.

BACKGROUND: Revascularization is the best alternative to reduce symptoms and to improve the limb salvage rate in patients with chronic limb-threatening ischemia (CLI). Alternative grafts as synthetic prostheses and allografts must be considered for patients without a suitable autologous graft. Our aim was to evaluate outcomes of cryopreserved allografts used as a vascular conduit for bypass surgery in the infrainguinal territory. METHODS: A retrospective analysis (January 1995 to January 2014) of the Registry of vascular and valvular allografts transplant in the autonomous community of Catalonia, Spain was performed for identifying patients with CLI who required infrainguinal bypass with cryopreserved arterial allografts. Statistical analysis was performed using SPSS, ver. 20, for Mac (Chicago). RESULTS: A total of 149 patients with CLI (mean age of 70.1 years) were analyzed. One hundred two patients (68.5%) had a grade IV lesion (Fontaine classification). In the overall follow-up, 24.8% of patients required a reintervention. Overall graft occlusion, infection, and dilation rate were 52.3%, 6%, and 5.4% respectively. Overall 30-day mortality was 0.7%. Five-year primary patency rate and limb salvage rate were 38.6% and 50.2%, respectively. Survival rate at 5 years was 54.2%. Major adverse limb event (MALE)-free rate was 21.5% at 5 years. Revascularization to a distal target vessel was an independent positive predictive risk factor for a lower limb salvage rate and lower primary patency rate. Dyslipidemia was related to a lower limb salvage rate and represents a risk factor involved in MALEs. CONCLUSIONS: Although arterial allografts seem to represent a suboptimal alternative, some selected patients could beneficiate from them. Five-year results are disappointing, and more studies are required to know other predictive factors for better selection of patients.

The value of surgeon-specific outcome data: results of a questionnaire.

OBJECTIVES: The publication of surgeon-specific data has been controversial. To assess the profession's opinion, a forum was organized at the 2015 EACTS meeting followed by a questionnaire of the value of surgeon-specific outcome and its impact. METHODS: A series of presentations were made including assessments of quality and safety in one major European country, the relationship between volume and outcome, the role of guidelines, the effect of publication of results on training, and discussion for and against publication of surgeon-specific data. A questionnaire was given to all attendees at the forum on the value of surgeon-specific data and their impact on the specialty. RESULTS: The questionnaire was completed by 118 attendees. Of the total, 69% felt that mortality is a surrogate for quality and that it should be reported at the hospital and unit level as opposed to the individual surgeon level, but 81% wished there were different criteria for quality outcome. Of the total, 91% felt that the individual surgeons' data should be collected but not published in public portals, and that publication produces risk-averse behaviour; 65% felt that it hinders innovation; 86% felt that EuroSCORE II is not reliable in identifying high-risk patients and the same number felt that it has affected entry into the specialty. CONCLUSIONS: The information that is collectable will be published, but we can control the way in which it is published and presented.

[Surgery in the Cardiovascular Surgical Intensive Care Unit]. / Reintervenciones en una Unidad de Cuidados Intensivos de Cirugía Cardiovascular.

BACKGROUND: To analyze the indications, actions and results of the operations performed in the Cardiovascular Surgery Intensive Care Unit. METHODS: Retrospective analysis of consecutive non-selected adult patients operated in the ICU. All operations were included. Descriptive statistics were used. RESULTS: Between 2008 and 2013, 3379 consecutive adult patients were operated upon. A total of 124 operations were performed in the ICU in 109 patients, 70 male (64.2%) and 39 female (35.8%) with a mean age of 61.6 years (12-80). This represented 3.2% of all operations. During the study period, 185 patients (5.5%) were reoperated for postoperative bleeding/tamponade in the operating room. The index interventions were for valvular heart disease (34.9%), aortic disease (22.9%), ischemic heart disease (15.6%), combined valvular/ischemic (12%), valvular/aorta (11%) and miscellaneous (3.6%). The indications for reoperation were persistent bleeding 54 (43.5%), pericardial tamponade 41 (33%), low cardiac output 13 (10.5%), cardiac arrest/arrhythmia 8 (6.5%), respiratory insufficiency 6 (4.8%) and acute ischemic limb 2 (1.7%). Operations performed were: mediastinal exploration 73 (58.9%), implant/removal of ECMO 17 (13.7%), sternal closure 16 (12.9%), open resuscitation 9 (7.3%), subxyphoid drainage 7 (5.6%) and femoral embolectomy 2 (1.6%). Overall mortality was 33%. There was one case of mediastinitis (0,9%), with no difference from patients operated in the regular operating room. CONCLUSIONS: Operations in the ICU represent a safe, life-saving alternative in specific subgroups of patients. The risk of wound infection is not increased, unstable patients are not transferred and there is time savings.

Valvular Heart Disease Epidemics.

BACKGROUND AIM OF THE STUDY: The real burden of valvular heart disease (VHD) is scarcely known, as several factors may potentially lead to its increased prevalence. The study aim was to assess the prevalence of VHD and its treatment in the authors' environment to plan the healthcare requisites for optimal management of the condition. METHODS: A retrospective analysis was conducted of data acquired from patients who had been assessed at different consultation levels for cardiovascular disorders during a six-month period between January and June 2014 in public health referral area of 500,00 inhabitants. Patients included were those admitted to hospital cardiology, cardiac surgery and geriatric care units (n = 1,083), as well as ambulatory patients attending cardiology-specific outpatient clinics at the authors' hospital or at two ascribed primary care centers (n = 852). Data were registered regarding the epidemiology, etiology, echocardiography and treatment of patients in whom VHD was detected. RESULTS: Among a total of 1,935 adult patients, moderate or severe valve disease was identified in 453 cases (23.4%) who were evaluated for cardiovascular disease. The prevalence of VHD increased with age. Multivalvular moderate-severe dysfunction was present in two valves in 33% and in three valves in 5.7% of patients. Significant mitral valve disease was present in 39% and aortic valve disease in 48% of patients. The etiology of the valvular lesions was degenerative in 60%, functional in 15.5%, rheumatic in almost 10%, congenital in 6%, due to endocarditis in only 3%. Patients with VHD represented up to 24.2% of the in-hospital admissions. An interventional treatment was required in 55% of the patients (mostly surgical valve procedures). CONCLUSION: The present study results showed that VHD is a frequent occurrence and is increasingly prevalent with age, constituting up to one-fourth of all in-hospital admissions for cardiovascular disease. VHD is a growing public health problem that should be addressed with appropriate resources to improve research into its nature, diagnosis and treatment.

Cardiac valve replacement in patients with antiphospholipid syndrome.

OBJECTIVE: To analyze the results of cardiac valve replacement in a multicenter cohort of patients with antiphospholipid syndrome (APS) and to identify prognostic factors of poor outcome. METHODS: We performed a retrospective analysis of clinical manifestations (cardiac involvement and APS characteristics), operative and early postoperative courses, and long-term followup. All of the patients fulfilled the Sapporo criteria for APS. Logistic regression analyses were performed to identify those variables associated with adverse outcomes. RESULTS: Between 1981 and 2008, 33 valvular replacements were carried out in 32 patients with APS. The mean ± SD age at the time of surgery was 43.09 ± 14.08 years. Thirty patients were women. Primary APS was present in 21 patients. The median followup time after surgery was 33.5 months (range 0-192 months). The mitral valve was the most frequently replaced (22 of 33). Mechanical valve replacement was performed in 23 patients (71.9%). The mortality rate was 12.5% (1 cardiogenic shock, 1 septic shock, 1 following renal transplantation, and 1 hemorrhagic stroke). Fourteen patients experienced 20 complications (8 major bleeding, 5 thrombotic events, 2 valvular deteriorations, 2 third-degree atrioventricular block, 1 endocarditis, 1 cardiac tamponade, and 1 cardiac failure). Fifty percent of the patients had an uneventful outcome. CONCLUSION: Morbidity and mortality were high in APS patients undergoing valve replacement surgery. Most complications were related to thrombosis and bleeding. Anticoagulation must be carefully monitored to prevent hemorrhagic and thrombotic complications.

Current state of the surgical treatment of atrial fibrillation.

Surgery of atrial fibrillation (AF) was first described in 1991 by James Cox in what was named the Cox-Maze procedure, and over the years it has been considered the gold-standard treatment, with best results in maintaining sinus rhythm in the long term. Nevertheless, the complexity and aggressivity of the first techniques of cut-and-sew limited the application of this procedure, and few centers were dedicated to AF surgery. In the past years, however, new devices able to ablate atrial tissue with cryotherapy, radiofrequency, or ultrasounds have facilitated this operation. In the mid-term, other energy devices with laser or microwave have been abandoned due to a lack of consistency in getting transmural lesions in a consistent and reproducible manner. Additionally, better knowledge of the physiopathology of AF, with the importance of triggering zones around the pulmonary veins, has started new minimally invasive techniques to approach paroxysmal and persistent AF patients through thoracoscopy.

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European association of cardio-thoracic surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

AIMS: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

[Validation of the EuroSCORE probabilistic model in patients undergoing coronary bypass grafting]. / Validación del modelo probabilístico EuroSCORE en pacientes intervenidos de injerto coronario.

INTRODUCTION AND OBJECTIVES: EuroSCORE utilizes a probabilistic model for predicting the risk of in-hospital mortality in patients undergoing cardiac surgery. It is a useful instrument for evaluating quality of care. The model has two variants: the logistic EuroSCORE and the additive EuroSCORE. The aim of this study was to validate the EuroSCORE model in patients undergoing surgery at Hospital Clínic in Barcelona, Spain, and to compare the results obtained with the two variants. METHODS: The study included all patients who received a coronary artery bypass graft (CABG) at Hospital Clínic in Barcelona in two consecutive years. The model's validity was assessed on the basis of its calibration (using the Hosmer-Lemeshow test) and its discrimination (using the receiver operating characteristic [ROC] curve). The two models were compared by carrying out a descriptive analysis of mortality for the whole group and for different risk groups, and by determining the models' discriminative power. RESULTS: A total of 498 patients underwent CABG surgery and were included in the study. The Hosmer-Lemeshow test showed that the model's calibration was satisfactory (P=.32) and the area under the ROC curve was 0.83. The observed in-hospital mortality rate was 5.8%. The predicted rate was 4.2% with the logistic EuroSCORE and 3.9% with the additive EuroSCORE. Large differences were observed in high-risk patients. In these patients, the mortality predicted by the logistic variant was closer to the actual mortality. CONCLUSIONS: EuroSCORE's validity was found to be satisfactory and the model can be used to evaluate quality of care. In high-risk patients, mortality estimated using the logistic model was closer to the actual mortality.

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

AIMS: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

AIMS: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Effects of cyclosporine, tacrolimus and sirolimus on vascular changes related to immune response.

BACKGROUND: Despite the use of newer immunosuppressors such as sirolimus (SRL) and tacrolimus (TRL) in heart transplantation, the rate of humoral rejection has remained unchanged. The aim of this study was to analyze the immunologic and histologic effects of cyclosporine (CsA), SRL, and TRL in a porcine model of arterial transplantation. METHODS: Each transplant recipient animal (n = 49) received an autograft and an allograft and was then allocated to one of four treatment groups and a 7- or 30-day follow-up period, as follows: a WOT group (without immunosuppressor treatment), 7 days (n = 6) and 30 days (n = 5); a CsA group, 7 days (n = 5) and 30 days (n = 6); an SRL group, 7 days (n = 7) and 30 days (n = 8); and a TRL group, 7 days (n = 6) and 30 days (n = 6). The presence of donor-specific antibodies (DSA) was tested at the end of the follow-up period. Morphometric parameters and inflammatory infiltration were analyzed in the explanted grafts. RESULTS: At 30-day follow-up, SRL was the only treatment capable of suppressing DSA formation (0 of 7 vs 4 of 5 in the WOT group; p < 0.05). SRL completely prevented aneurismal dilation and reduced the number of macrophages in the allografts. TRL treatment achieved a greater reduction of T lymphocytes. CsA did not prevent the reduction in total vascular area at 7 days that was achieved with the SRL and TRL groups. Animals treated with CsA had the largest number of T lymphocytes and macrophages in both follow-up periods. CONCLUSIONS: SRL prevented DSA formation and reduced the number of macrophages as compared with TRL and CsA.

Device migration in hybrid technique for apical muscular ventricular septal defects closure.

Muscular ventricular septal defects still require complex surgical procedures for their repair. We have used a hybrid approach for closure of these ventricular septal defects in patients needing open-heart surgery. It consists of the deployment of a ventricular septal occluder, as used in transcatheter procedures inside the defect under direct vision after cardiopulmonary bypass establishment. Through this paper, we report a case to illustrate a new and simple technique to avoid one of the most dramatic complications after this procedure: the migration of the closure device.

Elective cardiac surgery using Celsior or St. Thomas No. 2 solution: a prospective, single-center, randomized pilot study.

OBJECTIVE: Celsior is a crystalloid solution specifically designed for solid-organ transplantation. Due to its advanced combination of solutes, we wanted to evaluate its safety, efficacy, and possible benefits when used as blood cardioplegia in elective cardiac surgery in a single-center, randomized, controlled clinical trial, comparing its performance with a well-established cardioplegic solution. METHODS: Patients programmed for aortic valve replacement were randomized to receive either St. Thomas No. 2 or Celsior as blood cardioplegia with the same administration protocol. Intraoperative and postoperative variables concerning myocardial protection were registered and compared. RESULTS: A total of 60 patients were enrolled and randomized (Celsior, 30; St. Thomas, 30). There were no significant differences in baseline and preoperative variables. Volume of cardioplegic solution, number of administrations needed and the amount of potassium added were similar in both groups. Patients in the Celsior group showed a higher incidence of spontaneous sinus rhythm after myocardial ischemia (77% vs 40%, p=0.004) and fewer patients required defibrillation (17% vs 43%, p=0.024) for ventricular reperfusion arrhythmias. Postoperatively, there were no significant differences in troponin I release, inotropic and vasopressor drug support, ICU stay, and postoperative evolution. There were no deaths in the study. CONCLUSIONS: Celsior solution used as blood cardioplegia is effective and seems to be safe in elective aortic valve replacement when compared in this pilot study with a standard cardioplegic solution used worldwide. Fast return to sinus rhythm and lower incidence of reperfusion arrhythmias in the Celsior group may reflect a better myocardial protection during cardioplegic arrest. More investigation is needed to elucidate its performance in elective surgery.