Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Changes in outcomes over time in intermediate-risk patients treated for severe aortic stenosis.

BACKGROUND: The advent of transcatheter aortic valve replacement (TAVR) has changed the practice of treating patients with severe aortic stenosis (AS). Heart-Teams have improved their decision-making process to refer patients to the best and safest treatment. The evidence allowed centers to increase funding and TAVR volume and extend indications to different risk categories of patients. This study evaluates the outcomes of intermediate-risk patients treated for severe AS in an academic center. METHODS: Between 2012 and 2019, 812 patients with AS underwent TAVR or surgical aortic valve replacement (SAVR). A propensity score-matching analytic strategy was used to balance groups and adjust for time periods. Outcomes were recorded according to the Society of Thoracic Surgeons Guidelines; the primary outcome being 30-day mortality and the secondary outcomes being perioperative course and complications. RESULTS: No difference in mortality was seen but complications differed: more postoperative transient ischemic attacks, permanent pacemaker implantations, and perivalvular leaks in the transcatheter group, while more acute kidney injuries, atrial fibrillation, delirium, postoperative infections and bleeding, tamponade and need for reoperation in the surgical group as well as a longer hospital length-of-stay. However, over the years, morbidities/mortality decreased for all patients treated for AS. CONCLUSIONS: Data showed an improvement in morbidities/mortality for intermediate-risk patients treated with SAVR or TAVR. Increased funding allowed for a higher TAVR volume by increasing access to this technology. Also, the difference in complications could impact healthcare costs. By incorporating important metrics such as length-of-stay, readmission rates, and complications into decision-making, the Heart-Team can improve clinical outcomes, healthcare economics, and resource utilization.

The effect of storage solutions, gene therapy, and antiproliferative agents on endothelial function and saphenous vein graft patency.

Vein graft failure remains a major concern after coronary artery bypass graft operations, and is initiated by loss of endothelial cell integrity. Preservation of saphenous vein grafts in the optimal solution after meticulous harvesting can limit the endothelial damage. Despite both experimental and clinical results in favor of buffered solutions, normal saline is still the most widely used solution. This review examines the literature to identify the most optimal storage solutions currently available for vein graft preservation.

Clinical considerations and challenges in TAV-in-TAV procedures.

Transcatheter aortic valve replacement (TAVR) has emerged as a viable treatment for aortic valve disease, including low-risk patients. However, as TAVR usage increases, concerns about long-term durability and the potential for addition interventions have arisen. Transcatheter aortic valve (TAV)-in-TAV procedures have shown promise in selected patients in numerous registries, offering a less morbid alternative to TAVR explantation. In this review, the authors aimed to comprehensively review the experience surrounding TAV-in-TAV, summarize available data, discuss pre-procedural planning, highlight associated challenges, emphasize the importance of coronary obstruction assessment and provide insights into the future of this technique.

The Ross Procedure in Children and Infants: A Systematic Review With Pooled Analyses.

Background: The Ross procedure is a surgical option for congenital aortic stenosis that involves replacing the diseased aortic valve with a pulmonary autograft. Little is known about outcomes in children, particularly those younger than 1 year. Methods: A systematic review with pooled analyses was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Inferred individual patient data were extracted from life tables. The primary end points were early (≤30 days) and late (>30 days) mortality rates following the Ross procedure in children. Secondary end points were freedom from reintervention for the right ventricular outflow tract and pulmonary autograft. These end points were assessed in the overall population of children. Sensitivity analyses were performed in subgroups younger than 1 year of age (infants) and in noninfant children. Results: A total of 25 studies on 2737 patients met inclusion criteria. The pooled early survival rate was 96.0% (95% confidence interval [CI]: 95.1%-96.8%) overall and 86.8% (95% CI: 82.1%-90.3%) among infants. Pooled overall 10-year survival, freedom from pulmonary autograft reintervention, and freedom from right ventricular outflow tract reintervention rates were 91.1%, 90.2%, and 79.7%, respectively. Corresponding pooled rates in infants were 79.3%, 87.1%, and 51.2%. Mortality was significantly higher among infants compared with noninfant children (hazard ratio: 3.38, 95% CI: 2.44-4.68; P < 0.001). In metaregression analyses, younger age was strongly associated with poorer survival and higher reintervention rates. Conclusions: Modest survival and autograft reoperation rates were observed following the Ross procedure in children. Surgery in infancy was strongly associated with poorer survival and higher reintervention rates.

Contexte: L'intervention de Ross est une option chirurgicale visant à corriger une sténose aortique congénitale. Elle consiste à remplacer une valve aortique pathologique en utilisant la propre valve pulmonaire du patient (autogreffe pulmonaire). Les résultats de cette intervention ont été peu étudiés chez les enfants, en particulier chez les enfants de moins d'un an. Méthodologie: Une revue systématique avec analyses des données groupées a été menée en respectant les critères PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Les données dérivées de patients individuels ont été tirées de tables de survie. Les principaux critères d'évaluation étaient les taux de mortalité précoce (≤ 30 jours) et tardive (> 30 jours) à la suite de l'intervention de Ross réalisée chez des enfants. Les critères d'évaluation secondaires étaient l'absence de nouvelle intervention pour la chambre de chasse du ventricule droit et pour l'autogreffe pulmonaire. Ces paramètres ont été évalués pour l'ensemble de la population pédiatrique. Des analyses de sensibilité ont été réalisées dans des sous-groupes de patients âgés de moins d'un an (nourrissons) et d'enfants plus âgés. Résultats: Au total, 25 études portant sur 2 737 patients répondaient aux critères d'inclusion. Les taux de survie précoce étaient de 96,0 % (intervalle de confiance [IC] à 95 %; 95,1 à 96,8 %) dans l'ensemble des patients et de 86,8 % (IC à 95 %; 82,1 à 90,3 %) chez les nourrissons. Le taux de survie globale à 10 ans, d'absence de nouvelle intervention pour l'autogreffe pulmonaire et d'absence de nouvelle intervention pour la chambre de chasse du ventricule droit étaient respectivement de 91,1 %, de 90,2 % et de 79,7 % (données groupées). Les taux correspondant pour le sous-groupe composé de nourrissons étaient de 79,3 %, de 87,1 % et de 51,2 % (données groupées). La mortalité était significativement plus élevée chez les nourrissons comparativement aux enfants plus âgés (rapport des risques instantanés : 3,38, IC à 95 % : 2,44 à 4,68; p < 0,001). Dans les analyses de métarégression, le jeune âge était fortement corrélé à un taux de survie plus bas et à des taux plus élevés de nouvelles interventions. Conclusions: Des taux modestes de survie et de réopération d'autogreffe ont été observés après la procédure de Ross chez les enfants. La chirgurgie pendant la petite enfance était fortement associée à une survie plus faible et à des taux de réintervention plus élevés.

Clinical relevance of transcranial Doppler in a cardiac surgery setting: embolic load predicts difficult separation from cardiopulmonary bypass.

BACKGROUND: During cardiac surgery, transcranial Doppler (TCD) represents a non-invasive modality that allows measurement of red blood cell flow velocities in the cerebral arteries. TCD can also be used to detect and monitor embolic material in the cerebral circulation. Detection of microemboli is reported as a high intensity transient signal (HITS). The importance of cerebral microemboli during cardiac surgery has been linked to the increased incidence of postoperative renal failure, right ventricular dysfunction, and hemodynamic instability. The objective of this study is to determine whether the embolic load is associated with hemodynamic instability during cardiopulmonary bypass (CPB) separation and postoperative complications. METHODS: A retrospective single-centre cohort study of 354 patients undergoing cardiac surgery between December 2015 and March 2020 was conducted. Patients were divided in tertiles, where 117 patients had a low quantity of embolic material (LEM), 119 patients have a medium quantity of microemboli (MEM) and 118 patients who have a high quantity of embolic material (HEM). The primary endpoint was a difficult CPB separation. Multivariate logistic regression was used to determine the potential association between a difficult CPB separation and the number of embolic materials. RESULTS: Patients who had a difficult CPB separation had more HITS compared to patients who had a successful CPB separation (p < 0.001). In the multivariate analysis, patients with MEM decreased their odds of having a difficult CPB weaning compared to patients in the HEM group (OR = 0.253, CI 0.111-0.593; p = 0.001). In the postoperative period patients in the HEM group have a higher Time of Persistent Organ Dysfunction (TPOD), a longer stay in the ICU, a longer duration under vasopressor drugs and a higher mortality rate compared to those in the MEM and LEM groups. CONCLUSION: The result of this study suggests that a high quantity of cerebral embolic material increases the odds of having a difficult CPB separation. Also, it seems to be associated to more complex surgery, a longer CPB time, a higher TPOD and a longer stay in the ICU. Six out of eight patients who died in this cohort were in the HEM group.

Outcomes Following Transcatheter Mitral Valve Replacement Using Dedicated Devices in Patients With Mitral Annular Calcification.

BACKGROUND: Patients with mitral regurgitation (MR) and morphologic presence of relevant mitral annular calcification (MAC) represent a challenging phenotypic subset with limited treatment options. OBJECTIVES: The aim of this study was to assess the feasibility of transcatheter mitral valve replacement (TMVR) using dedicated devices for the treatment of MAC patients. METHODS: Consecutive patients with symptomatic MR receiving TMVR and with available computed tomography data from the CHOICE-MI (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) multicenter registry were stratified by the presence of none or mild mitral annular calcification (MACnone/mild) vs moderate or severe mitral annular calcification (MACmod/sev). RESULTS: Among 279 eligible patients (median age = 76.0 years [Q1-Q3: 71.0-81.0 years], EuroSCORE II = 6.2% [Q1-Q3: 3.9%-12.1%]), 222 (79.6%) presented with MACnone/mild and 57 (20.4%) with MACmod/sev. Patients with MACmod/sev had a higher prevalence of extracardiac arteriopathy (P = 0.011) and primary MR (P < 0.001). Although the technical success rate and the extent of MR elimination did not differ, TMVR treatment in MACmod/sev patients was associated with higher rates of postprocedural bleeding complications (P = 0.02) and renal failure (P < 0.001). Functional improvement at the 1- and 2-year follow-up did not differ between groups. At the 2-year follow-up, there were no differences between patients with MACmod/sev and MACnone/mild regarding all-cause mortality (38.5% vs 37.7%; P = 0.76), cardiovascular mortality (21.3% vs 24.9%; P = 0.97), and all-cause mortality or heart failure hospitalization (52.4% vs 46.7%; P = 0.28) CONCLUSIONS: TMVR in patients with MACmod/sev is associated with higher rates of postprocedural complications but similar rates of survival, MR resolution, and functional improvement compared to MACnone/mild. Further studies are necessary to define the role of dedicated TMVR devices in this population. (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry [CHOICE-MI]; NCT04688190).

TAVI-PREP: A Deep Learning-Based Tool for Automated Measurements Extraction in TAVI Planning.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to open-heart surgery for treating severe aortic stenosis. Despite its benefits, the risk of procedural complications necessitates careful preoperative planning. METHODS: This study proposes a fully automated deep learning-based method, TAVI-PREP, for pre-TAVI planning, focusing on measurements extracted from computed tomography (CT) scans. The algorithm was trained on the public MM-WHS dataset and a small subset of private data. It uses MeshDeformNet for 3D surface mesh generation and a 3D Residual U-Net for landmark detection. TAVI-PREP is designed to extract 22 different measurements from the aortic valvular complex. A total of 200 CT-scans were analyzed, and automatic measurements were compared to the ones made manually by an expert cardiologist. A second cardiologist analyzed 115 scans to evaluate inter-operator variability. RESULTS: High Pearson correlation coefficients between the expert and the algorithm were obtained for most parameters (0.90-0.97), except for left and right coronary height (0.8 and 0.72, respectively). Similarly, the mean absolute relative error was within 5% for most measurements, except for left and right coronary height (11.6% and 16.5%, respectively). A greater consensus was observed among experts than when compared to the automatic approach, with TAVI-PREP showing no discernable bias towards either the lower or higher ends of the measurement spectrum. CONCLUSIONS: TAVI-PREP provides reliable and time-efficient measurements of the aortic valvular complex that could aid clinicians in the preprocedural planning of TAVI procedures.

Extracorporeal membrane oxygenation and microaxial left ventricular assist device in cardiogenic shock: Choosing the right mechanical circulatory support to improve outcomes.

Objective: To evaluate the outcomes of patients supported with Impella (CP/5.0) or venoarterial extracorporeal membrane oxygenation (VA-ECMO) for cardiogenic shock according to shock phenotype. The primary end point was 30-day survival. Methods: A retrospective study of patients supported with Impella (CP/5.0) or VA-ECMO between 2010 and 2020 was performed. Patients were grouped according to 1 of 2 shock phenotypes: isolated left ventricular (LV) dysfunction versus biventricular dysfunction or multiple organ failure (MOF). The local practice favors Impella for isolated LV dysfunction and VA-ECMO for biventricular dysfunction or MOF. Results: Among the 75 patients included, 17 (23%) had isolated LV dysfunction. Patients with biventricular dysfunction or MOF had a greater median lactate level compared with those with isolated LV dysfunction (7.9 [2.9-11.8] vs 3.8 [1.1-5.8] mmol/L, respectively). Among patients with isolated LV dysfunction, 30-day survival was 46% for the Impella group (n = 13) and 75% for VA-ECMO (n = 4). Among patients with biventricular dysfunction or MOF, 30-day survival was 9% for the Impella group (n = 11) and 28% for VA-ECMO (n = 47). Patients supported with Impella 5.0 had better 30-day survival compared with those supported with Impella CP, for both shock phenotypes (83% vs 14% and 14% vs 0%, respectively). Conclusions: In this small cohort, patients supported with Impella for isolated LV dysfunction and VA-ECMO for biventricular dysfunction or MOF had acceptable survival at 30 days. Patients with biventricular dysfunction or MOF who were supported by Impella had the lowest survival rates. Patients with isolated LV dysfunction who were supported with VA-ECMO had good 30-day survival.

Impact of Valve Academic Research Consortium 3 (VARC-3) minor access site vascular complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to investigate the impact of Valve Academic Research Consortium 3 minor access site vascular complications (VCs) in patients who underwent percutaneous transfemoral (TF) transcatheter aortic valve implantation (TAVI). METHODS: This single-centre retrospective study included consecutive patients who underwent percutaneous TF-TAVI from 2009 to 2021. A propensity score-matched analysis was performed to compare early and long-term clinical results between patients with VC and without VC (nVC). RESULTS: A total of 2161 patients were included, of whom 284 (13.1%) experienced access site VC. Propensity score analysis allowed to match 270 patients from the VC group with 727 patients from the nVC group. In the matched cohorts, the VC group showed longer operative times (63.5 vs 50.0 min, P < 0.001), higher operative and in-hospital mortality (2.6% vs 0.7%, P = 0.022; and 6.3% vs 3.2%, P = 0.040, respectively), longer hospital length of stay (8 vs 7 days, P = 0.001) and higher rates of blood transfusion (20.4% vs 4.3%, P < 0.001) and infectious complications (8.9% vs 3.8%, P = 0.003). Overall survival during follow-up was significantly lower in the VC group (hazard ratio 1.37, 95% CI 1.03-1.82, P = 0.031) with 5-year survival rates being 58.0% (95% CI 49.5-68.0%) and 70.7% (95% CI 66.2-75.5%) for the VC and nVC groups, respectively. CONCLUSIONS: This retrospective study observed that minor access site VCs during percutaneous TF-TAVI can be serious events affecting early and long-term outcomes.