Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

BACKGROUND: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P=0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P=1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P=0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P=0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P=0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P=0.80). CONCLUSIONS: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445.

Is Transcatheter Aortic Valve Replacement Futile in Patients Over Ninety Years of Age?

Background: Clinical outcomes and quality of life (QoL) indices are not well described after transcatheter aortic valve replacement (TAVR) in patients aged ≥ 90 years. Methods: We conducted a retrospective cohort study of TAVR among nonagenarian patients between 2008 and 2020. The survival of TAVR patients among nonagenarians was compared to the provincial estimated survival for an age- and sex-matched general population. QoL was assessed up to 1 year postintervention, using standardized questionnaires. Results: During the study period, n = 268 patients aged ≥ 90 years were evaluated for severe aortic stenosis. TAVR was performed in n = 171 (48% female; median [IQR] Rockwood Clinical Frailty Scale score: 4 [3-4]); n = 84 underwent medical therapy; and n = 13 underwent surgical aortic valve replacement. Survival was significantly better following TAVR, compared to that after MT (adjusted hazard ratio [95% CI]: 1.99 [1.37-2.88], P < 0.001). TAVR patients demonstrated a survival advantage compared with the general population, with an estimated relative mortality of 0.86 (0.75-0.87). TAVR patients showed sustained improvements in functional status and QoL up to 1 year compared to baseline (all P < 0.05): the 6-minute walk test results improved from 192 to 252 m; the Kansas City Cardiomyopathy Questionnaire score improved from 64 to 81; the Duke Activity Status Index score improved from 13 to 16; and the health state scale result of the Euro Quality of life - 5 Dimensions improved from 63% to 74%. Conclusions: Nonagenarians undergoing TAVR experience a slightly better survival rate, compared to that of an age- and sex-matched general population, and they have significant improvements in functional status and several QoL indices following the procedure.

Introduction: Les résultats cliniques et les indices de la qualité de vie (QdV) après le remplacement valvulaire aortique par cathéter (RVAC) chez les patients ≥ 90 ans ne sont pas bien décrits. Méthodes: Nous avons réalisé une étude de cohorte rétrospective sur le RVAC chez les patients nonagénaires entre 2008 et 2020. Nous avons comparé la survie des patients nonagénaires qui avaient subi un RVAC à la survie provinciale estimée d'une population générale appariée selon l'âge et le sexe. Nous avons évalué la QdV jusqu'à 1 an après l'intervention au moyen de questionnaires standardisés. Résultats: Durant la période étudiée, nous avons inclus des patients (n =268) âgés de ≥ 90 ans et évalués pour une sténose aortique sévère. Le RVAC a été réalisé chez 171 patients (48 % de sexe féminin ; score médian [écart interquartile] à l'échelle de fragilité clinique de Rockwood [Rockwood Clinical Frailty Scale] : 4 [3-4]) ; 84 ont reçu un traitement médical (TM) ; 13 ont subi un remplacement valvulaire aortique chirurgical. La survie était significativement meilleure à la suite du RVAC, comparativement à celle des patients TM (rapport de risque ajusté [IC à 95 %] : 1,99 [1,37-2,88], P < 0,001). Par rapport à la population générale, les patients ayant subi un RVAC ont démontré un avantage sur le plan de la survie, soit une mortalité relative estimée de 0,86 (0,75-0,87). Les patients ayant subi un RVAC ont montré des améliorations continues de l'état fonctionnel et de la QdV jusqu'à 1 an par rapport au début (toutes les valeurs P < 0,05) : les résultats à l'épreuve de marche de 6 minutes sont passés de 192 à 252 m ; les scores au questionnaire Kansas City Cardiomyopathy Questionnaire (KCCQ) sont passés de 64 à 81 ; les scores au questionnaire Duke Activity Status Index (DASI) sont passés de 13 à 16 ; les résultats à l'échelle de l'état de santé de l'EQ-5D (de l'EuroQol Group) sont passés de 63 % à 74 %. Conclusions: Les nonagénaires qui subissent un RVAC ont un taux de survie légèrement meilleur à celui d'une population générale appariée selon l'âge et le sexe, et montrent des améliorations significatives de leur état fonctionnel et de plusieurs indices de la QdV à la suite de l'intervention.

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease.

OBJECTIVES: The INSPIRIS aortic valve combines the RESILIA proprietary tissue preservation process and an expandable stent frame to benefit future transcatheter valve-in-valve procedures. As the INSPIRIS valve became commercially available in 2017, mid-term outcome reports are scarce. We aimed to evaluate mid-term safety and echocardiographic performance of the INSPIRIS valve in comparison to its predecessor, the Carpentier Edwards Perimount Magna Ease (ME). METHODS: This study was a retrospective single-centre study. Clinical results included early postoperative outcomes, mid-term mortality and readmission for cardiovascular cause or stroke. Echocardiographic follow-up (FU) was performed at discharge and 1-3, 6, 12 and 24 months. Clinical end point analyses were accomplished with a propensity score matching analysis and FU echocardiographic data comparisons using pairwise analyses and linear mixed-effect models. RESULTS: We included 953 patients who received an INSPIRIS (n = 488) or ME (n = 463) bioprosthesis between January 2018 and July 2021. In the matched population (n = 217 per group), no significant difference in short-term outcomes was observed, survival was similar at 30 months (INSPIRIS: 94% vs ME: 91%, P = 0.89), but freedom from readmission was higher in the INSPIRIS group (94% vs 86%, P = 0.014). INSPIRIS valves had a lower gradient at discharge (∼10 vs 14 mmHg, P < 0.001), 1-3 months (∼10 vs 12 mmHg, P < 0.001) and 24 months (∼11 vs 17 mmHg, P < 0.001) in paired analyses and significantly lower evolution of mean transvalvular gradients compared to ME. CONCLUSIONS: This study represents the largest comparative evaluation of the INSPIRIS to the ME valves, which demonstrated safe clinical outcomes and favourable haemodynamic performance at 2 years. Long-term FU is underway.

Fractional Flow Reserve to Assess Coronary Artery Disease in Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation: Long-Term Outcomes.

Background: The long-term outcomes of patients undergoing functional assessment of coronary lesions with fractional flow reserve (FFR) while awaiting transcatheter aortic valve implantation (TAVI) are unknown. Data on the safety of intracoronary adenosine use in this setting are scarce. The objectives of this study were to describe (1) the long-term outcomes based on the coronary artery disease (CAD) assessment strategy used and (2) the safety of intracoronary adenosine in patients with severe aortic stenosis (AS). Methods: 1023 patients with severe AS awaiting TAVI were included. Patients were classified according to their CAD assessment strategy: angiography guided or FFR guided. Patients were further subdivided according to the decision to proceed with percutaneous coronary intervention (PCI): angiography-guided PCI (375/1023), angiography-guided no-PCI (549/1023), FFR-guided PCI (50/1023), and FFR-guided no-PCI (49/1023). Patients were followed up for the occurrence of major adverse cardiac and cerebrovascular events (MACCEs). Results: At a mean follow-up of 33.7 months, we observed no significant differences in terms of major adverse cardiovascular and cerebrovascular events (MACCE) in the angiography-guided group (42.4%) compared with the FFR-guided group (37.4%) (p = 0.333). When comparing outcomes of the FFR-guided no-PCI group (32.7%) with the angiography-guided PCI group (46.4%), no significant difference was noted (p = 0.999). Following intracoronary adenosine, a single adverse event occurred. Conclusions: In this population, intracoronary adenosine is safe and well tolerated. We found no significant benefit to an FFR-guided strategy compared with an angiography-guided strategy with respect to MACCEs. Although clinically compelling, avoiding the procedural risks of PCI by deferring the intervention in functionally insignificant lesions failed to show a statistically significant benefit.

Long-term echocardiographic data, mechanisms of failure, and reintervention outcomes of the Epic valve in mitral position-a large observational cohort.

OBJECTIVES: Long-term echocardiographic reports on mitral valve (MV) porcine xenograft bioprosthesis (Epic) are lacking, and postreintervention outcomes of failed Epic are unknown. We aimed to assess the mechanisms and independent predictors of Epic failures and to compare short- and mid-term outcomes according to reintervention type. METHODS: We included consecutive patients (n = 1397; mean age: 72 ± 8 years; 46% female; mean follow-up: 4.8 years) who received the Epic during mitral valve replacement (MVR) at our institution. Clinical, echocardiographic, reintervention, and outcomes data were retrieved from our prospective institution's database or government statistics. RESULTS: Gradients and effective orifice area of the Epic were stable over 5-years follow-up. A total of 70 (5%) patients had a MV reintervention at median follow-up of 3.0 (0.7-5.4) years due to prosthesis failure, by redo-MVR (n = 38; 54%), valve-in-valve (n = 19; 27%), paravalvular leak (PVL) closure (n = 12; 17%), or thrombectomy (n = 1). Mechanisms of failure were 27 (1.9%) structural valve deterioration (SVD; all leaflet tear); 16 (1.1%) non-SVD (15 PVL, 1 pannus); 24 (1.7%) endocarditis; and 4 (0.3%) thrombosis. Freedom from all-cause and SVD-related MV reintervention at 10 years are 88% and 92%, respectively. Independent predictors of reintervention were age, baseline atrial fibrillation, initial MV etiology, and moderate or greater PVL at discharge (all P ≤ .05). Comparison of redo-MVR and valve-in-valve revealed no significant difference in early outcomes or mid-term mortality (all P ≥ .16). CONCLUSIONS: The Epic Mitral valve has stable hemodynamics through 5 years and is associated with low incidence of SVD and reintervention, mostly due to endocarditis and leaflet tear without calcification. Reintervention type had no influence on early outcomes and mid-term mortality.

Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria.

BACKGROUND: The Valve Academic Research Consortium (VARC)-3 definition for myocardial injury after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. OBJECTIVES: This study sought to determine the incidence, predictors, and clinical impact of periprocedural myocardial injury (PPMI) following TAVR as defined by recent VARC-3 criteria. METHODS: We included 1,394 consecutive patients who underwent TAVR with a new-generation transcatheter heart valve. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs ≥15 times according to the VARC-2 definition). Baseline, procedural, and follow-up data were prospectively collected. RESULTS: PPMI was diagnosed in 193 (14.0%) patients. Female sex and peripheral artery disease were independent predictors of PPMI (P < 0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.69, 95% CI: 1.50-4.82; P = 0.001) and 1-year (for all-cause mortality, HR: 1.54; 95% CI: 1.04-2.27; P = 0.032; for cardiovascular mortality, HR: 3.04; 95% CI: 1.68-5.50; P < 0.001) follow-up. PPMI according to VARC-2 criteria had no impact on mortality. CONCLUSIONS: About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria, and baseline factors like female sex and peripheral artery disease determined an increased risk. PPMI had a negative impact on early and late survival. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.

Syncope in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: No data exist on the clinical and prognostic significance of syncope in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. METHODS: A total of 1705 consecutive patients with severe aortic stenosis undergoing TAVR in a tertiary university centre between 2007 and 2021 were included and classified according to the presence of syncope before the TAVR procedure. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database. RESULTS: A total of 115 patients (7%) presented with syncope before the TAVR procedure. Of these, 15 patients (13%) showed arrhythmic episodes as the probable cause of the syncope, and all of them had pacemakers implanted at a median of 13 (6 to 53) days before the TAVR procedure. Patients with syncope were older (82 ± 8 years vs 80 ± 8 years, P = 0.001) and had a higher rate of pacemaker implantation before the TAVR procedure (27% vs 14%, P < 0.001), with no differences between groups regarding the severity of aortic stenosis (transvalvular gradient, valve area). There were no differences between groups in 30-day (adjusted hazard ratio [HR], 1.28; 95% confidence interval [CI], 0.46-3.60) and 1-year (adjusted HR, 0.71; 95% CI, 0.0.35-1.45) mortality following TAVR. CONCLUSIONS: Syncope was not associated with a more advanced valvular disease and had no significant prognostic impact on patients undergoing TAVR. However, arrhythmias and conduction-system disturbances were more common in patients with previous syncope and might play a relevant role in the pathogenesis of syncope in patients with aortic stenosis.

Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial.

Importance: Selenium contributes to antioxidative, anti-inflammatory, and immunomodulatory pathways, which may improve outcomes in patients at high risk of organ dysfunctions after cardiac surgery. Objective: To assess the ability of high-dose intravenous sodium selenite treatment to reduce postoperative organ dysfunction and mortality in cardiac surgery patients. Design, Setting, and Participants: This multicenter, randomized, double-blind, placebo-controlled trial took place at 23 sites in Germany and Canada from January 2015 to January 2021. Adult cardiac surgery patients with a European System for Cardiac Operative Risk Evaluation II score-predicted mortality of 5% or more or planned combined surgical procedures were randomized. Interventions: Patients were randomly assigned (1:1) by a web-based system to receive either perioperative intravenous high-dose selenium supplementation of 2000 µg/L of sodium selenite prior to cardiopulmonary bypass, 2000 µg/L immediately postoperatively, and 1000 µg/L each day in intensive care for a maximum of 10 days or placebo. Main Outcomes and Measures: The primary end point was a composite of the numbers of days alive and free from organ dysfunction during the first 30 days following cardiac surgery. Results: A total of 1416 adult cardiac surgery patients were analyzed (mean [SD] age, 68.2 [10.4] years; 1043 [74.8%] male). The median (IQR) predicted 30-day mortality by European System for Cardiac Operative Risk Evaluation II score was 8.7% (5.6%-14.9%), and most patients had combined coronary revascularization and valvular procedures. Selenium did not increase the number of persistent organ dysfunction-free and alive days over the first 30 postoperative days (median [IQR], 29 [28-30] vs 29 [28-30]; P = .45). The 30-day mortality rates were 4.2% in the selenium and 5.0% in the placebo group (odds ratio, 0.82; 95% CI, 0.50-1.36; P = .44). Safety outcomes did not differ between the groups. Conclusions and Relevance: In high-risk cardiac surgery patients, perioperative administration of high-dose intravenous sodium selenite did not reduce morbidity or mortality. The present data do not support the routine perioperative use of selenium for patients undergoing cardiac surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT02002247.

Should Bilateral Internal Thoracic Arteries be Used in Patients with Chronic Kidney Disease?

Preoperative renal dysfunction is a major determinant of operative and long-term mortality following cardiac surgery. The objective of this study was to assess early and long-term results of CABG in patients with preoperative chronic kidney disease (CKD) using a bilateral internal thoracic artery (BITA) strategy, compared to those without CKD. We retrospectively analyzed data for 2,111 consecutive patients who underwent CABG with BITA between 2000 and 2019. One-to-many propensity score matching was performed to produce a cohort of 132 patients with CKD (defined as an estimated glomerular filtration rate <60 mL/min/1.73 m2), matched to 358 patients with normal renal function (non-CKD). The primary end-point of interest was late freedom from all-cause mortality. Late hospital readmissions were also assessed. Mean eGFR and serum creatinine were: 49.8 versus 84.3 mL/min/m2 and 146.1 versus 83.6 µmol/L (CKD vs non-CKD, P< 0.001). In-hospital outcomes were similar among matched patients, including mortality (CKD 0.8% vs non-CKD 0%, P= 0.31). At a median follow-up of 6.9 years, there was no significant difference in survival between both groups (hazard ratio (HR) 1.37, 95% confidence interval (CI) 0.87-2.16, P= 0.17). Hospital readmission for cardiovascular causes (including repeat coronary revascularization) was comparable between the 2 groups. However, the risk of hospital readmission for renal causes was higher in patients with CKD (6.7%) compared to non-CKD (1.2%). In a propensity score-matched cohort of patients undergoing BITA-CABG, CKD was not associated with increased early or late mortality, nor was there a greater risk of hospital readmission for cardiovascular events.

Preoperative physical frailty assessment among octogenarians undergoing cardiac surgery: Upgrading the "eyeball" test.

OBJECTIVES: There are many well-described, but as yet unproven, physical ability tools to assess frailty. The objective of this study was to evaluate the effectiveness of 4 preoperative physical tests in predicting mortality, morbidity, and functional outcomes among octogenarians undergoing cardiac surgery. METHODS: Between 2016 and 2019, 200 patients aged 80 years or more undergoing elective cardiac surgery were prospectively recruited. Four physical tests were performed preoperatively: 5-m walk time, timed up-and-go, 5 time sit-to-stand, and handgrip strength tests. The primary end point was a composite of in-hospital mortality, neurologic, and pulmonary complications. Multivariate analysis was performed. RESULTS: In-hospital mortality was 1.5%. Slow performance on the 5-m walk test (time ≥6.4 seconds) was the only independent predictor of the composite end point among the tests evaluated (odds ratio, 2.70; 95% confidence interval, 1.34-5.45; P = .006). At follow-up, patients with a slow 5-m walk test had a significantly lower midterm survival compared with patients with a normal test result (1-year survival 91.5% vs 98.7%, log-rank P = .03). Mean Physical and Mental Component Scores of the 12-item short form survey were 47.2 ± 8.3 and 53.6 ± 5.9, respectively, which are comparable to those of a general population aged more than 75 years. CONCLUSIONS: The 5-m walk time test is an independent predictor of a composite of in-hospital mortality and major morbidity, as well as midterm survival. This test could be used as a simple adjunctive preoperative tool for octogenarians undergoing cardiac surgery.

Prosthetic choice in mitral valve replacement for severe chronic ischemic mitral regurgitation: Long-term follow-up.

BACKGROUND: Prosthetic choice for mitral valve replacement is generally driven by patient age and patient and surgeon preference, and current guidelines do not discriminate between different etiologies of mitral valve disease. Our objective was to assess and compare short- and long-term outcomes after mitral valve replacement among patients with biological or mechanical prostheses in the setting of severe ischemic mitral regurgitation. METHODS: Between 2000 and 2016, 424 patients underwent mitral valve replacement for severe ischemic mitral regurgitation at our institution, using biological prosthesis in 188 (44%) and mechanical prosthesis in 236 (56%). A 1:1 propensity score match (n = 126 per group) and inverse probability of treatment weighting were used to compare groups. Short-term outcomes included in-hospital mortality and other cardiovascular adverse events. Long-term outcomes included survival and hospital readmission for cardiovascular causes, stroke, and major bleeding. RESULTS: In-hospital mortality and early postoperative adverse events were similar between groups in the propensity score match and inverse probability of treatment weighting cohorts. Overall long-term survival was similar at 5 and 9 years, but mechanical prosthesis recipients were more frequently readmitted to hospital for cardiovascular causes, including stroke and non-neurological bleeding in propensity score matching and inverse probability of treatment weighting analyses (all P values < .004). Type of prosthesis did not independently influence all-cause mortality (hazard ratio, 1.01; 95% confidence interval, 0.71-1.43; P = .959), but placement of a mechanical prosthesis was associated with increased risk of readmission for cardiovascular events (hazard ratio, 1.65; 95% confidence interval, 1.17-2.32; P = .004) among matched patients. CONCLUSIONS: The type of prosthesis has no influence on long-term survival among patients with severe ischemic mitral regurgitation undergoing mitral valve replacement. There may be an increased risk of neurologic events and serious bleeding associated with mechanical prostheses.

Clinical impact of the heart team on the outcomes of surgical aortic valve replacement among octogenarians.

OBJECTIVES: The effectiveness of a multidisciplinary heart team in the management of patients with severe symptomatic aortic stenosis is unknown. This study evaluated the impact of a heart team on the outcomes of surgical aortic valve replacement in octogenarians. METHODS: Between May 2007 and January 2016, 528 patients aged 80 years or more were referred to our institutional heart team for a transcatheter aortic valve replacement. Among these, 101 were redirected to surgical aortic valve replacement (heart team group). These patients were compared with a surgical aortic valve replacement cohort (n = 506) without prior heart team screening (non-heart team group), taken from the same time period. Propensity score matching with bootstrap analysis was performed; 76 heart team patients were matched to 76 non-heart team patients. Early and late outcomes including survival and readmission for cardiovascular causes were compared. RESULTS: Matched subgroups were largely comparable; congestive heart failure and echocardiographic pulmonary hypertension were more prevalent in the heart team group. In-hospital mortality was significantly lower in the matched heart team group (0% vs 6.0%, bootstrap mean difference 6.0%, 95% confidence interval, 2.2-9.8). The risk of stroke, low cardiac output state, reexploration for bleeding, pneumonia, and prolonged ventilation was also significantly lower in the heart team group. There was no significant between-group difference regarding late survival (hazard ratio, 0.86, 95% confidence interval, 0.55-1.33, P = .49) or readmission for cardiovascular reasons (hazard ratio, 0.70, 95% confidence interval, 0.41-1.20, P = .19). CONCLUSIONS: Preoperative multidisciplinary assessment of octogenarians by a heart team was associated with lower in-hospital mortality and adverse events after surgical aortic valve replacement.

Incidence and clinical impact of tachyarrhythmic events following transcatheter aortic valve replacement: A review.

Transcatheter aortic valve replacement (TAVR) is well established for treating severe symptomatic aortic stenosis. Whereas broad information on the epidemiology, clinical implications, and management of bradyarrhythmias after TAVR is available, data about tachyarrhythmic events remain scarce. Despite the progressively lower risk profile of TAVR patients and the improvement in device characteristics and operator skills, approximately 10% of patients develop new-onset atrial fibrillation (NOAF) after TAVR. The proportion of patients in whom NOAF actually corresponds to previously undiagnosed silent atrial fibrillation (AF) has not been properly determined. The transapical approach, the need for pre- or post- balloon dilation, and the presence of periprocedural complications have been associated with a higher risk of NOAF. Older age, left atrial volume, or worse functional class are patient-derived risk factors shared with preprocedural AF. NOAF after TAVR has been associated with poorer survival and a higher incidence of cerebrovascular events. However, patient management differs markedly among different centers, especially with regard to anticoagulation in patients with short-duration AF episodes detected in the periprocedural setting and in cases of silent NOAF detected during continuous electrocardiographic (ECG) monitoring. Evidence about ventricular arrhythmias is even more scarce than for AF. Some case reports of sudden cardiac death after TAVR in patients with a pacemaker have identified ventricular tachycardia or ventricular fibrillation in device interrogation. TAVR has been shown to reduce the arrhythmic burden, but a significant proportion of patients (16%) present with complex premature ventricular complex arrhythmias within the year after TAVR. Whether these events are related to poorer outcomes is unknown. Continuous ECG monitoring after TAVR may help describe the frequency, risk factors, and prognostic implications of tachyarrhythmias in this population.

From the Evolut Pro to the Evolut FX self-expanding transcatheter aortic valve replacement systems: current status and future perspectives.

INTRODUCTION: Since the initial experience with the CoreValve (Medtronic, Minneapolis, Minnesota), there have been continuous iterations of this valve system in order to improve procedural success and reduce periprocedural complications. The Evolut Pro, Pro+, and FX are the latest generations of this transcatheter heart valve (THV). AREAS COVERED: This review paper aims to analyze the main characteristics and clinical evidence about the Evolut Pro THV and summarize the main iterations of the newer generation Evolut FX valve system. EXPERT OPINION: The Evolut Pro system has been associated with good clinical outcomes and excellent valve hemodynamic performance including reduced rates of paravalvular leaks. Technical enhancements to improve valve positioning, orientation, and vascular access have been implemented in the newer generation Evolut FX system.

Impact of residual transvalvular gradient on clinical outcomes following valve-in-valve transcatheter aortic valve replacement.

BACKGROUND: High (≥20 mmHg) postprocedural mean transvalvular gradients are relatively common among valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) recipients, but its clinical impact remains controversial. METHODS: Observational study including 190 consecutive ViV-TAVR recipients. Patients were classified according to the presence of high (≥20 mmHg) or low (<20 mmHg) residual mean transvalvular gradient on post-procedural echocardiography. Functional status (NYHA class, DASI), exercise capacity (6MWT), and quality of life (KCCQ) were evaluated at baseline and at 1-year follow-up. RESULTS: 73 (38.4%) and 117 (61.6%) patients exhibited high (HG) and low (LG) postprocedural gradients, respectively. Baseline characteristics were well balanced between groups except for a lower rate of large (>23 mm) surgical valves, atrial fibrillation, and aortic regurgitation as mechanism of valve failure in the HG group (p < 0.05 for all). After a median follow-up of 3 (1-5) years, there were no differences between HG and LG groups in HF hospitalization (HRadj: 1.38, 95%CI 0.44-4.22, p = 0.57), cardiac death (HRadj: 0.50; 95%CI 0.11-2.41, p = 0.39), all-cause mortality (HRajd: 0.71; 95%CI 0.35-1.46, p = 0.36), or the composite endpoint of heart failure/all-cause mortality (HRadj:1.00; 95%CI 0.52-1.94, p = 0.98). At 1-year follow-up, functional status (ΔDASI score, HG: 9.9 ± 10.9, LG: 9.9 ± 12.5, padj = 0.41), exercise capacity (Δ6MWT, HG: 111 ± 67 m, LG: 103 ± 124 m, padj = 0.14), and quality of life parameters (ΔKCCQ, HG: 27 ± 18, LG: 17 ± 21, padj = 0.12) improved similarly in both groups. CONCLUSIONS: HG as evaluated by echocardiography following ViV-TAVR were not associated with a negative effect on clinical outcomes including major adverse events, functional status, exercise capacity and quality of life parameters.

Macroscopic and microscopic features of surgically explanted transcatheter aortic valve prostheses.

OBJECTIVES: With the extended indications of transcatheter aortic valve (TAV) replacement (TAVR) to lower-risk patients, there is an increasing number of patients requiring surgical explantation of failed TAV. We sought to describe macroscopic and microscopic features of surgically explanted percutaneous aortic valve prostheses. METHODS: Preoperative and surgical characteristic of patients undergoing surgical explantation of TAV were retrospectively analyzed from 2007 to 2020. Surgical and pathologic features of these valves, and outcomes of the surgical valve replacement were described. RESULTS: Out of 1764 patients who underwent a TAVR procedure, 21 were operated for TAV failure. Isolated or combined indications for surgery included: significant paravalvular leak (n = 15), delayed prosthesis migration (n = 5), significant increase of trans-TAV gradients (n = 6), and endocarditis (n = 3). Mean time elapsed between TAVR and explantations was 674.9 ± 803.9 days. Macroscopic lesions found on explanted percutaneous valves were severe adhesions to the aorta (n = 10), calcifications (n = 7), leaflet thrombosis (n = 4), and vegetations (n = 3). Except for patients with endocarditis, one or more pathological lesions were found in 15 patients. Pathology analyses on these valves showed fibro-calcific degenerations (n = 12), pannus formation (n = 9), and chronic inflammation (n = 3). One patient (4.8%) died after surgical explantation, and 13 (61.9%) had concomitant procedures. The survival rate at 1 year was 94.4%. CONCLUSIONS: Microscopic findings of fibro-calcific leaflet degeneration, and pannus formation in addition to macroscopic calcification and thrombosis present early, (within a mean of 2 years) after TAVR. Further investigation with a higher number of patients and echocardiographic follow-up is warranted.

New-onset persistent left bundle branch block following sutureless aortic valve replacement.

OBJECTIVE: To evaluate the incidence, predictive factors and prognostic value of new-onset persistent left bundle branch block (NOP-LBBB) in patients undergoing sutureless surgical aortic valve replacement (SU-SAVR). METHODS: A total of 329 consecutive patients without baseline conduction disturbances or previous permanent pacemaker implantation (PPI) who underwent SU-SAVR with the Perceval valve (LivaNova Group, Saluggia, Italy) in two centres from 2013 to 2019 were included. Patients were on continuous ECG monitoring during hospitalisation and 12-lead ECG was performed after the procedure and at hospital discharge. NOP-LBBB was defined as a new postprocedural LBBB that persisted at hospital discharge. Baseline, procedural and follow-up clinical and echocardiography data were collected in a dedicated database. RESULTS: New-onset LBBB was observed in 115 (34.9%) patients, and in 76 (23.1%) persisted at hospital discharge. There were no differences in baseline and procedural characteristics between patients with (n=76) and without (n=253) NOP-LBBB. After a median follow-up of 3.3 years (2.3-4.4 years), patients with NOP-LBBB had a higher incidence of PPI (14.5% vs 6.3%, p=0.016), but exhibited similar rates of all-cause mortality (19.4% vs 19.2%, p=0.428), cardiac mortality (8.1% vs 9.4%, p=0.805) and heart failure readmission (21.0% vs 23.2%, p=0.648), compared with the no/transient LBBB group. NOP-LBBB was associated with a decrease in left ventricular ejection fraction (LVEF) at 1-year follow-up (delta: -5.7 vs +0.2, p<0.001). CONCLUSIONS: NOP-LBBB occurred in approximately a quarter of patients without prior conduction disturbances who underwent SU-SAVR and was associated with a threefold increased risk of PPI along with a negative impact on LVEF at follow-up.