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.

Clinical and structural outcomes of neocommissural alignment in transaxillary and transcarotid transcatheter aortic valve implantation with a self-expandable transcatheter heart valve.

Objectives: This study analyzes neocommissural alignment and the clinical and hemodynamic outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve. Methods: We performed a retrospective, single-center analysis of early outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve. Primary outcomes were neocommisural alignment, in-hospital mortality, and valve hemodynamic performance. Commissural alignment between native and transcatheter heart valves was assessed by transesophageal echocardiogram before and after the procedure. Results: Between October 2021 and November 2022, 40 consecutive patients were treated with the Acurate neo2 through a transaxillary or transcarotid approach. Access was achieved via the left subclavian artery in 30 cases and the left common carotid artery in 10 cases, with a mean vessel diameter of 6.7 mm. Implants most commonly used were size M (37.5%), L (35%), and S (27.5%). On the basis of transesophageal echocardiogram analysis, there was no significant difference in mean commissural orientation between native (mean, 65.1°; SD, 41.3°) and neocommissures (mean, 64°; SD, 44.1°) (P = .661). Mean commissural orientation did not significantly differ between native and neocommissures (P = .661). Optimal alignment or mild commissural misalignment was achieved in 99.5% of cases. There were no cases of severe commissural misalignment. Postprocedural mean values for peak and mean gradients were 12.7 mm Hg and 5.2 mm Hg, respectively. There were 2 cases of moderate paravalvular leak and 4 cases of mild paravalvular leak. Conclusions: This patient-specific technique for transaxillary and transcarotid insertion of the Acurate neo2 delivery system prevents implantations with more than mild commissural misalignment and with a high device success rate.

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire.

BACKGROUND: The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we evaluated health status outcomes, based on the TASQ, in patients with severe AS undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). METHODS: The TASQ registry was a prospective observational registry. Patients with severe AS from nine centres in Europe and one in Canada underwent either SAVR or transfemoral TAVR. Patients completed the TASQ, Kansas City Cardiomyopathy Questionnaire and Short Form-12 V.2 prior to the intervention, predischarge, and at 30-day and 3-month follow-ups. Primary end point was the TASQ score. RESULTS: In both the TAVR (n=137) and SAVR (n=137) cohorts, significant increases were observed in all three scores. The overall TASQ score improved as did all but one of the individual domains at 3 months after the intervention (p<0.001). TASQ health expectations were the only domain which worsened (p<0.001). Across TASQ subscores, significant changes were evident from the time of discharge in the TAVR and 30-day follow-up in the SAVR cohort. In a categorical analysis of the TASQ, 39.7% of the TAVR group and 35.0% of the SAVR group had a substantially improved health status at 3 months compared with baseline. CONCLUSIONS: The TASQ captured changes in QoL among patients with severe AS who were treated with TAVR or SAVR. QoL improved substantially after either intervention, as indicated by changes in the TASQ overall score at 3 months. TRIAL REGISTRATION NUMBER: NCT03186339.

Mid-term assessment of structural valve deterioration of perceval S sutureless prosthesis using the last European consensus definition.

OBJECTIVES: Durability of sutureless aortic bioprosthetic valves remains a major issue. The aim of this study was to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) of the Perceval bioprosthesis using the new proposed standardized definitions. METHODS: All patients who underwent aortic valve replacement with sutureless Perceval S prostheses up to September 2016 were included. Clinical and echocardiographic follow-up was performed. New standardized definitions were used to assess the durability of sutureless bioprosthetic valves. From 2013 to 2016, 214 patients were included. RESULTS: The mean age and EuroSCORE II were 79 years and 2.74. Thirty-day mortality was 0.47%. The survival rate was 96.8%, 88.1% and 85.7% at 1, 3 and 4 years, respectively. The median echocardiographic follow-up was 3.28 years. The mean pressure gradient was 11.3 mmHg. No cases showed evidence of severe SVD, 17 patients had moderate SVD with a mean pressure gradient of 24 mmHg and 8 patients had definite late BVF. The incidence of moderate SVD and BVF at 4 years was 8.8% and 2.9%, respectively. CONCLUSIONS: Mid-term follow-up to 6.3 years after aortic valve replacement with the Perceval bioprosthesis documents favourable haemodynamic and clinical outcomes and low rates of SVD and BVF.

Non-contrast transoesophageal echo-guided transapical transcatheter aortic valve replacement: 10-year experience of a renoprotective strategy.

OBJECTIVES: This study aims to evaluate the efficacy, safety and long-term outcomes of a renoprotective non-contrast, transoesophageal echocardiography-guided transapical (TA) transcatheter aortic valve replacement (TAVR) strategy with a balloon-expandable prosthesis, as well as to determine its impact on renal function. METHODS: Between 2009 and 2019, 200 consecutive patients underwent a non-contrast, transoesophageal echocardiography-guided TA TAVR with a balloon-expandable prosthesis. RESULTS: The device success rate was 95.5%. Transoesophageal echocardiography-guided deployment demonstrated a low rate of procedure-related complications: 9.5% of acute kidney injury, 8% postoperative bleeding, 6% low-cardiac output, 4.5% postprocedural aortic regurgitation ≥+2, 4% implantation of permanent pacemaker and 2% stroke. There were no significant differences between preoperative and on discharge estimated glomerular filtration rate (53.9 ± 22.2 vs 54.3 ± 22.9 ml/min/1.73 m2, P = 0.60). Logistic regression analysis confirmed postoperative bleeding as an independent predictor for acute kidney injury (odds ratio (OR) 11.148, 95% confidence interval 3.537-35.140, P < 0.001). In-hospital mortality was 7.5%. The mean follow-up was 48.5 ± 39.9 months. Renal function and patient's chronic kidney disease stage did not significantly vary during follow-up. Long-term cumulative survival at 1, 5 and 10 years was 84.2 ± 0.027%, 42.9 ± 0.038% and 32.5 ± 0.044%, respectively. Renal function affected on neither in-hospital mortality nor long-term survival. CONCLUSIONS: Non-contrast, transoesophageal echocardiography-guided TA TAVR is a safe and reproducible technique with a low incidence of periprocedural complications that avoids the use of contrast and mitigates the incidence of acute kidney injury.

Postoperative Plasma Mitochondrial DNA and Cytokine Profiles of Elderly Patients Undergoing Minimally Invasive Aortic Valve Replacement.

INTRODUCTION: Mitochondrial DNA (mtDNA) is gaining increasing interest as a marker of cellular damage and could also act as an inflammatory mediator in cardiopulmonary bypass induced postoperative inflammatory response. Although minimally invasive heart valve surgery reportedly reduces inflammation, the mtDNA and cytokine profile in this context remains unclear. MATERIALS AND METHODS: Here, we report a prospective series of 40 elderly patients with aortic stenosis who underwent bioprosthetic aortic valve replacement (AVR) through upper ministernotomy with either a sutureless (n = 20) or a conventional (n = 20) valve. Primary end points included serial plasma levels of mtDNA (T1: at baseline; T2: 4 hours after surgery; and T3: 24s hour after surgery), cytokines (interleukin-6 [IL-6], tumor necrosis factor-α [TNF-α]), and myocardial necrosis biomarkers (MNBs), whereas secondary end points included clinical and echocardiographic data. RESULTS: Significant increases in the postoperative plasma levels (T2) of mtDNA, cytokines, and MNBs were observed in all patients. The postoperative plasma levels of mtDNA, TNF-α, and MNBs showed no significant differences between the treatment groups, although there was a trend toward lower levels in the sutureless group. The decreases in aortic cross-clamp and cardiopulmonary bypass times seen in the sutureless group were associated with significant lower postoperative levels (T2 and T3) of IL-6. CONCLUSION: AVR through upper ministernotomy was associated with a significant increase in postoperative plasma levels of mtDNA and cytokines. There was no difference in the mtDNA levels between the sutureless and conventional valve groups, suggesting a similar level of inflammation in both groups. However, the shorter operation time observed in the sutureless valve group was associated with significantly lower postoperative levels of IL-6, indicating potential clinical benefits.

Surgical technique modifies the postoperative atrioventricular block rate in sutureless prostheses.

BACKGROUND: The main objective was to analyse the impact of the modification of the Perceval S implantation technique on the prevalence of postoperative atrioventricular block, which requires a permanent pacemaker, in our aortic valve replacement series. In addition, we attempted to identify those risk factors that are related to the appearance of this complication. METHODS: Five hundred and seventy-two valve replacements were carried out with PERCEVAL S in our centre up to July 2018. Use of modified technique (n=302). Minimally invasive approach (n=340). Associated coronary surgery (n=95). Patients with pacemakers prior to surgery (n=27) and associated mitral or tricuspid valve surgery (n=26) were excluded. We analysed variables of interest that could influence the increase in postoperative atrioventricular block. Technique performed, disorders of intraventricular conduction and pre/intraoperative characteristics. The influence of the modified technique was analysed. RESULTS: Five hundred and nineteen aortic valve replacements with PERCEVAL S. Age (years) (median 77, interquartile range 8). Height (cm) (159, 13.5). Euroscore II (%) (2.25, 2.27). Postoperative atrioventricular block standard technique (n=23, 10.14%). Modified technique (n=14, 4.30%) (P=0.009). Multivariate regression analysis. Final model AUC =0.740, maximum model AUC =0.774 (P>0.05). Includes: Technique used (P=0.024), height (P=0.043) and disorders of interventricular conduction, right bundle branch block (P=0.005), trifascicular block (P=0.008). CONCLUSIONS: In our experience, the modified technique significantly decreases the incidence of postoperative atrioventricular block that requires a permanent pacemaker in the aortic valve replacement with PERCEVAL S. The prior electrocardiographic presence of right bundle branch block, trifascicular block and the height of the patient are associated with an increased risk of blocking.

Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry.

Background: Patients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency. Methods: The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS. Discussion: Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients. Trial registration number: NCT03186339.

Valve-Sparing Tetralogy of Fallot Repair With Intraoperative Dilation of the Pulmonary Valve. Mid-Term Results.

Deleterious long-term effects of chronic pulmonary regurgitation after repair of tetralogy of Fallot have become evident during the last decades. Subsequently, some groups have developed strategies to spare the pulmonary valve function at the time of repair with good early results. However, mid-term outcomes are scarce in the literature and in some cases controversial. The aim of our study is to report our results mid-term with valve-sparing repair of tetralogy of Fallot. We retrospectively reviewed patients undergoing tetralogy of Fallot repair and having preservation of the pulmonary valve with intraoperative dilation at our institution. From June 2009 through June 2017, 42 patients underwent valve-sparing tetralogy of Fallot repair. Median age and weight at surgery were 5.2 months and 7.2 kg. Median preoperative pulmonary valve diameters and Z scores by echocardiography were 6.4 mm (range 4.5-11 mm) and -2.3 (range -1.3 to -4.5). No patient died in our series. For a median follow-up of 45 months, the pulmonary valve has grown by Z score (P < 0.0001) as well as the pulmonary trunk (P= 0.00216). Significant pulmonary regurgitation has developed in 9 patients (21.4%). No patient has required reintervention/reoperation for recurrent right ventricular outflow tract obstruction. Patients with tetralogy of Fallot who had valve-sparing repair with intraoperative dilation of the pulmonary valve show good early and mid-term results with respect to right ventricular outflow tract obstruction. The pulmonary valve annulus and the pulmonary trunk grow through follow-up. Progressive development of significant pulmonary regurgitation is seen in more than 20% of patients. Long-term data with this approach and comparison with a population of patients undergoing a transannular patch repair are required to establish the real utility of this approach.

Mitochondrial DNA haplogroups influence the risk of aortic stenosis.

AIM: The underlying pathophysiologic mechanisms of aortic stenosis are not clear. Mitochondrial dysfunction plays a role in many pathological conditions including cardiac diseases. We aimed to analyze the mitochondrial DNA haplogroups in a group of patients undergoing valve replacement surgery due to severe aortic stenosis. METHODS: Mitochondrial DNA haplogroups were assessed in 176 patients with severe aortic stenosis and 308 control subjects. Cardiovascular risk factors and demographics were similar in both groups. RESULTS: Patients carrying haplogroup Uk had a lower risk of developing aortic stenosis, especially compared to patients carrying haplogroup H (odds ratio = 0.507; 95% confidence interval: 0.270-0.952, p = 0.035). CONCLUSIONS: Mitochondrial DNA haplogroups could be involved in the development of severe aortic stenosis. Specifically, haplogroup H could be a risk factor and Uk a protective factor for severe aortic stenosis in a population from Spain.

Circulating Galectin-3 Following Heart Transplant: Long-term Dynamics and Prognostic Value.

INTRODUCTION AND OBJECTIVES: Circulating galectin-3 (Gal-3) is elevated and significantly correlates with all-cause and cardiovascular mortality in patients with heart failure. However, the relationship between serum Gal-3 and heart transplant (HT) outcomes is unclear. The aim of this study was to describe the longitudinal trend and prognostic value of Gal-3 levels after HT. METHODS: Banked serum samples were available from 122 HT recipients, collected before transplant and at 1, 3, 6, and 12 months posttransplant. Gal-3 levels in these serum samples were measured by enzyme immune assay. Multivariable Cox regression was performed to determine the prognostic value of 12-month posttransplant Gal-3 serum levels. The primary endpoint was the composite variable all-cause death or graft failure over long-term posttransplant follow-up. RESULTS: Circulating Gal-3 concentration steadily decreased during the first year after HT (median values: pretransplant, 19.1 ng/mL; 1-year posttransplant, 14.6 ng/mL; P<.001). Circulating Gal-3 levels 1-year posttransplant were associated with an increased risk of all-cause death or graft failure (adjusted HR per 1 ng/mL, 1.04; 95%CI, 1.01-1.08; P=.008). The predictive accuracy of this biomarker was moderate: area under the ROC curve, 0.72 (95%CI, 0.60-0.82; P<.001). CONCLUSIONS: Circulating Gal-3 steadily decreased during the first year after HT. However, 1-year posttransplant Gal-3 serum levels that remained elevated were associated with increased long-term risk of death and graft failure.

Efficacy and safety of transcatheter valve-in-valve replacement for Mitroflow bioprosthetic valve dysfunction.

OBJECTIVES: Bioprostheses with pericardial leaflets mounted externally on the stent pose a high risk for valve-in-valve (ViV) procedures. This study analyzed the efficacy and safety of ViV procedures for treating structural valve deterioration (SVD) in Mitroflow bioprostheses. METHODS: Between January 2012 and August 2017, 11 patients (mean age 80.3 ± 5.6 years) were treated for SVD of Mitroflow bioprostheses with transcatheter ViV procedures (six transapical [TA] and five transfemoral [TF]) using balloon expandable bioprostheses. RESULTS: All patients but one were in NYHA class III-IV. Mean STS PROM, euroSCORE I, and euroSCORE II were 8 ± 6.5%, 27.8 ± 11.5%, and 12 ± 5.9%, respectively. Two patients had a "porcelain aorta." The size of implanted valves were 23 mm in 10 cases and 26 mm in one case. One patient suffered a coronary occlusion during a TF approach. The mean volume of contrast used in TF implants was 163 ± 69.8 mL. No contrast media were used in TA procedures. There was one in-hospital death (10%). At 1 year of follow-up, peak and mean aortic gradients were 25.5 ± 5.8 mmHg and 15.5 ± 5.7 mmHg, respectively. One patient had mild paravalvular regurgitation. Cumulative survival was 90.9% at 1 year, 70.7% at 2 years, and 53% at 3 years. CONCLUSIONS: ViV procedures with balloon-expandable aortic valves provide good hemodynamic and clinical mid-term results for treating patients with a degenerated Mitroflow aortic bioprosthesis. Special care must be taken in small aortic roots, when the stented valve is in the supra-annular position to avoid coronary ostial obstruction.

Evolution of conservative treatment of acute traumatic aortic injuries: lights and shadows.

OBJECTIVES: The objective of this study is to compare early and long-term results in terms of survival and aortic complications for traumatic aortic injuries depending on the initial management strategy. METHODS: From January 1980 to January 2017, 101 patients with aortic injuries were divided into 3 groups according to management strategy at admission: 60 patients, conservative management; 26 patients, open surgery and 15 patients, endovascular repair. The groups were similar in terms of gender and trauma severity scores. RESULTS: All but 1 aortic-related complications and aortic-related mortality occurred in the conservative group (11.6% conservative vs 2.4% in both surgical and endovascular groups, P = 0.091). Total follow-up was 1109.27 patient-years. Survival in the conservative, surgical and endovascular group was 71.7%, 80.8% and 79.4% at 1 year, 68.2%, 80.8% and 79.4% at 5 years and 63.9%, 72.7% and 79.4% at 10 years, respectively (log-rank = 0.218). The rate of aortic-related complications was 58.3% in the conservative cohort. Cox regression identified the following risk factors for aortic-related complications: aortic injuries grade >I [odds ratio (OR), 3.05; P = 0.021], Trauma Injury Severity Score >50% (OR 1.21; P = 0.042) and the decade of treatment (OR 0.49; P = 0.011). CONCLUSIONS: Minimal aortic injuries seem to be an amenable target for medical management, but patients remain at risk of developing aortic-related complications. Close, long-term imaging surveillance is mandatory to detect such complications at an early stage.

Perceval Less Invasive Aortic Replacement Register: multicentric Spanish experience with the Perceval S bioprosthesis in moderate-high-risk aortic surgery.

OBJECTIVES: The development of new percutaneous and surgical techniques has reduced the risk associated with aortic valve replacement procedures. We present the results of a Spanish register after initiating a programme for sutureless prostheses in moderate-high-risk patients. METHODS: This prospective multicentre study was carried out from November 2013 to November 2016. Data were obtained from 448 patients in whom a Perceval S prosthesis was implanted. RESULTS: The mean age was 79.24 (standard deviation [SD] 4.1) years, and 61.2% were women. The estimated EuroSCORE I log risk was 11.15% (SD 7.6), with an observed mortality of 4.4% (20 patients). Isolated aortic valve replacement was performed on 69.26% of patients, with 64% involving ministernotomy. The incidence of neurological events was 2%, with 2 permanent cerebrovascular accidents, and 41 (9.2%) patients were implanted with a permanent endocavitary pacemaker. At discharge, 12 (2.6%) patients presented minimal periprosthetic leakage, and 4 (0.89%) patients had moderate leakage. There were 3 reinterventions during follow-up (2 endocarditis and 1 dysfunction due to periprosthetic leak progression). The mean gradient at discharge, 6 months and 1 year was 12.94 (SD 5.3) mmHg, 12.19 (SD 4.7) mmHg and 11.77 (SD 4.7) mmHg, respectively; 59.4% of the patients were octogenarians, with a survival rate of 98% at both 6 months and 1 year at discharge. There was neither valve migration nor early structural degeneration. The mean follow-up was 12 ± 3 months. The 6-month and 1-year mortality was 1.4% and 2.1%, respectively. CONCLUSIONS: This is a prospective multicentric study on the largest cohort of patients with sutureless valves conducted in Spain to date. It is a reproducible procedure that has enabled surgery on patients with a moderate-high risk with low morbidity and mortality, providing good haemodynamic results.