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The use of bioprosthetic valves for treating patients with severe valve disease has increased over the last 2 decades, and, as a consequence, a growing number of patients with failing surgical bioprosthesis is expected in the near future. In this setting, valve-in-valve (ViV) transcatheter aortic/mitral valve replacement (TAVR and TMVR) has emerged as an alternative to redo surgery. Despite the increasing experience in ViV procedures, the development of these techniques faces several specific challenges, mainly related to the unique anatomical and physiological characteristics presented in ViV-TAVR/TMVR. Subsequently, various approaches have been proposed to overcome ViV-related complications and pitfalls. A growing body of evidence is currently available concerning early- and long-term clinical outcomes of patients undergoing ViV-TAVR/TMVR. These data should be comprehensively evaluated by the Heart Team in the decision-making process involving patients with failing surgical bioprostheses. In this review, we aimed to delineate the technical challenges and risks associated with ViV-TAVR and ViV-TMVR, provide an updated overview of the main clinical results, and summarize the future perspectives of this evolving field.

Background Transcatheter edge-to-edge mitral valve repair may lead to a reduction in mitral valve area (MVA) and elevated mean transmitral gradient (TMG). The objectives of this study were to assess the value of baseline MVA by different imaging methods and to explore the associations between MVA indexed to body surface area or left ventricular forward stroke volume and postprocedural TMG. Methods Preprocedural echocardiographic images from 76 consecutive patients were retrospectively reviewed. MVA planimetry from two-dimensional (2D) transthoracic echocardiography (MVATTE), 2D transesophageal echocardiography in the transgastric view (MVA2D TEE), and three-dimensional (3D) transesophageal echocardiography (MVA3D) were measured. Postprocedural TMGs were assessed at 1 to 3 months and all-cause mortality at 1 year. Results Postprocedural mean TMG > 5 mm Hg was associated with a 3.42-fold (95% confidence interval [CI], 1.08–10.87; P = .04) increased risk for 1-year all-cause mortality. Patients with postprocedural TMG > 5 mm Hg (25% [19 of 76]) had significantly smaller preprocedural MVA3D (3.9 ± 0.8 vs 5.2 ± 1.3 cm2, P 5 mm Hg were, respectively, 3.9 cm2 (area under the curve [AUC] = 0.80; 95% CI, 0.66–0.94; sensitivity 62%, specificity 87%) and 4.6 cm2 (AUC = 0.68; 95% CI, 0.54–0.82; sensitivity 53%, specificity 80%). MVA3D indexed to body surface area and to stroke volume showed overall the best associations with postprocedural mean TMG > 5 mm Hg, with optimal thresholds, respectively, of 2.5 cm2/m2 (AUC = 0.88; 95% CI, 0.77–0.98; sensitivity 92%, specificity 74%) and 95 cm2/L (AUC = 0.87; 95% CI, 0.77–0.97; sensitivity 85%, specificity 82%). Conclusions Elevated TMG following transcatheter edge-to-edge mitral valve repair was associated with increased mortality. The present results indicate that MVA3D, MVA3D indexed to body surface area, and MVA3D indexed to stroke volume may be considered potential predictors of postprocedural TMG > 5 mm Hg and could help optimize patient selection, while the use of 2D methods for valve area were poorly associated with TMG.

Background: Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk after coronary artery bypass grafting surgery. Methods: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), a multicenter, placebo-controlled, double-blind trial, statin-treated patients with controlled low-density lipoprotein cholesterol and mild to moderate hypertriglyceridemia were randomized to 4 g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy end point (composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy end point (composite of cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The current analysis reports on the subgroup of patients from the trial with a history of coronary artery bypass grafting. Results: Of the 8179 patients randomized in REDUCE-IT, a total of 1837 (22.5%) had a history of coronary artery bypass grafting, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary end point (hazard ratio [HR], 0.76 [95% CI, 0.63–0.92]; P =0.004), in the key secondary end point (HR, 0.69 [95% CI, 0.56–0.87]; P =0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64 [95% CI, 0.50–0.81]; P =0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%–10.2%) in first events, with a number needed to treat of 16 (95% CI, 10–44) during a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs 3.1%; P =0.03) and a nonsignificant increase in bleeding, occurrences of adverse events were comparable between groups. Conclusions: In REDUCE-IT patients with a history of coronary artery bypass grafting, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

BACKGROUND The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. METHODS We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. RESULTS A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P���=���0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P���=���0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). CONCLUSIONS In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).

BACKGROUND OR PURPOSE We report our single-center experience with percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and primary hemostasis disorders (HD). METHODS Consecutive patients with primary HD who underwent a percutaneous LAAC were included. Baseline characteristics, procedural data, and clinical outcomes were prospectively collected and compared with the overall LAAC cohort without HD. RESULTS Since 2013, among 229 LAAC, 17 patients (7%) had a primary HD: thrombocytopenia (n = 5), myelodysplastic syndrome (n = 6), von Willebrand syndrome (n = 4), type A hemophilia (n = 1), and dysfibrinogenemia (n = 1). The HD population's age ranged from 61 to 87 years, and the median CHA2DS2VASc was 5. Periprocedural plasmatic management was required in 47% of patients. The immediate LAAC implantation success rate was 100%. Patients received a direct oral anticoagulant (DOA) (n = 9), dual antiplatelet (n = 6), aspirin (n = 1), or no therapy (n = 1) during the first six postoperative weeks, followed with single antiplatelet (n = 16) or no therapy (n = 1) during lifelong. After 20 months, the technical success rate and procedural success rate were 100% and 94%. Zero device-/procedure-related complication and only one life-threatening bleeding occurred. Compared to patients without HD (n = 212), a baseline history of bleeding was less frequent (53% vs 91%, p

OBJECTIVES The objective of this in vitro study was to compare Doppler versus catheter transvalvular pressure gradients (TPG) in third generations balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves (THV). BACKGROUND TPG is a key parameter to assess and follow valve hemodynamic function following transcatheter aortic valve implantation (TAVI). It remains uncertain and debated whether, and to which extent, TPGs differ according to the type of THV, that is, BE versus SE and to the method used for TPG measurement, that is, Doppler echocardiography versus cardiac catheterization. METHODS The CoreValve EVOLUT PRO 26 mm and the SAPIEN 3 23 mm THVs were tested in a left heart simulator using a 21 mm aortic annulus under following conditions: heart rate: 70 bpm, mean aortic pressure: 100 mmHg, stroke volume: 30, 70 and 100 ml. Mean TPGs were measured by continuous-wave Doppler and by micro-tip pressure catheters positioned in the left ventricle and at 50 mm downstream to the tip of the THV leaflets. RESULTS Doppler TPGs (9.5 ± 3.9 mmHg) were on average 40.5 ± 13.9% higher (p

Objectives The aim of this study was to evaluate clinical characteristics, mechanisms of failure, and outcomes of transcatheter aortic valve replacement (TAVR) explantation. Background Surgical explantation following TAVR may be required for structural valve degeneration, paravalvular leak, infection, or other reasons. However, in-depth data on indications and outcomes are lacking. Methods Data from a multicenter, international registry (EXPLANT-TAVR) of patients who underwent TAVR explantation were reviewed retrospectively. Explantations performed during the same admission as initial TAVR were excluded. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 6.7 months (interquartile range [IQR]: 1.0-18.8 months) after TAVR explantation and was 97.7% complete at 30 days and 86.1% complete at 1 year. Results From November 2009 to September 2020, 269 patients across 42 centers with a mean age of 72.7 ± 10.4 years underwent TAVR explantation. About one quarter (25.9%) were deemed low surgical risk at index TAVR, and median Society of Thoracic Surgeons risk at TAVR explantation was 5.6% (IQR: 3.2%-9.6%). The median time to explantation was 11.5 months (IQR: 4.0-32.4 months). Balloon-expandable and self-expanding or mechanically expandable valves accounted for 50.9% and 49.1%, respectively. Indications for explantation included endocarditis (43.1%), structural valve degeneration (20.1%), paravalvular leak (18.2%), and prosthesis-patient mismatch (10.8%). Redo TAVR was not feasible because of unfavorable anatomy in 26.8% of patients. Urgent or emergency cases were performed in 53.1% of patients, aortic root replacement in 13.4%, and 54.6% had concomitant cardiac procedures. Overall survival at last follow-up was 76.1%. In-hospital, 30-day, and 1-year mortality rates were 11.9%, 13.1%, and 28.5%, respectively, and stroke rates were 5.9%, 8.6%, and 18.7%, respectively. Conclusions The EXPLANT-TAVR registry reveals that surgical risks associated with TAVR explantation are not negligible and should be taken into consideration in the lifetime management of aortic stenosis.

Background: As a result of the COVID-19 pandemic first wave, reductions in ST-elevation myocardial infarction (STEMI) invasive care, ranging from 23% to 76%, have been reported from various countries. Whether this change had any impact on coronary angiography (CA) volume or on mechanical support device use for STEMI and post-STEMI mechanical complications in Canada is unknown. Methods: We administered a Canada-wide survey to all cardiac catheterization laboratory directors, seeking the volume of CA use for STEMI performed during the period from March 1 2020 to May 31, 2020 (pandemic period), and during 2 control periods (March 1, 2019 to May 31, 2019 and March 1, 2018 to May 31, 2018). The number of left ventricular support devices used, as well as the number of ventricular septal defects and papillary muscle rupture cases diagnosed, was also recorded. We also assessed whether the number of COVID-19 cases recorded in each province was associated with STEMI-related CA volume. Results: A total of 41 of 42 Canadian catheterization laboratories (98%) provided data. There was a modest but statistically significant 16% reduction (incidence rate ratio [IRR] 0.84; 95% confidence interval 0.80-0.87) in CA for STEMI during the first wave of the pandemic, compared to control periods. IRR was not associated with provincial COVID-19 caseload. We observed a 26% reduction (IRR 0.74; 95% confidence interval 0.61-0.89) in the use of intra-aortic balloon pump use for STEMI. Use of an Impella pump and mechanical complications from STEMI were exceedingly rare. Conclusions: We observed a modest 16% decrease in use of CA for STEMI during the pandemic first wave in Canada, lower than the level reported in other countries. Provincial COVID-19 caseload did not influence this reduction. Résumé: Introduction: Après la première vague de la pandémie de COVID-19, de nombreux pays ont déclaré une réduction de 23 % à 76 % des soins invasifs de l'infarctus du myocarde avec élévation du segment ST (STEMI). On ignore si ce changement a entraîné des répercussions sur le volume d'angiographies coronariennes (AC) ou sur l'utilisation des dispositifs d'assistance mécanique lors de STEMI et des complications mécaniques post-STEMI au Canada. Méthodes: Nous avons réalisé un sondage pancanadien auprès de tous les directeurs de laboratoire de cathétérisme cardiaque pour obtenir le volume d'utilisation des AC lors des STEMI réalisées durant la période du 1er mars 2020 au 31 mai 2020 (période de pandémie) et durant 2 périodes témoins (1er mars 2019 au 31 mai 2019 et 1er mars 2018 au 31 mai 2018). Le nombre de dispositifs d'assistance ventriculaire gauche utilisés et le nombre de cas de communications interventriculaires et de ruptures du muscle papillaire diagnostiqués ont également été enregistrés. Nous avons aussi évalué si le nombre de cas de COVID-19 enregistrés dans chaque province était associé au volume d'AC liées aux STEMI. Résultats: Au total, 41 des 42 laboratoires canadiens de cathétérisme (98 %) ont fourni des données. Lors de la comparaison de la première vague de la pandémie aux périodes témoins, nous avons noté une réduction modeste, mais significative, sur le plan statistique de 16 % (ratio du taux d'incidence [RTI] 0,84; intervalle de confiance à 95 % 0,80-0,87) des AC lors de STEMI. Le RTI n’était pas associé au nombre provincial de cas de COVID-19. Nous avons observé une réduction de 26 % (RTI 0,74; intervalle de confiance à 95 % 0,61-0,89) de l'utilisation de pompes à ballonnet intra-aortique lors de STEMI. L'utilisation d'une pompe Impella et les complications mécaniques après les STEMI étaient extrêmement rares. Conclusions: Nous avons observé une diminution modeste de 16 % de l'utilisation des AC lors de STEMI durant la première vague de la pandémie au Canada, soit une diminution plus faible que ce que les autres pays ont signalé. Le nombre provincial de cas de COVID-19 n'a pas influencé cette réduction.

Horizontal aorta (HA) is an anatomical feature that can pose significant technical challenges for the successful positioning of the bioprosthetic valve during transcatheter aortic valve replacement (TAVR). Physiological range of aortic angle (AA) is unknown; hence there is no cutoff AA for classifying HA. Moreover, patient characteristics predicting HA are under-investigated.This was a retrospective analysis of prospective collected data from 16 heart valve centers in Europe. The study utilized a common dataset with a priori agreed-upon definitions and variables. Eligible patients underwent TAVR between 2014 and 2020 and had multidetector computed tomographic imaging data available for determining the AA. The analysis described the distribution of AA and potential predictors of HA. Inter-center variability was also explored.For 4022 patients analyzed, the mean AA ± standard deviation was 49.4° ± 9.4° (median 49°, inter-quartile range [IQR] 12°, range 18-90°). There was no significant difference in mean AA between men and women (49.4° ± 9.1° vs. 49.6° ± 9.3°, respectively; p = 0.53); therefore, 49.4° was accepted as the cutoff value for HA in subsequent analyses. Covariates significantly associated with HA included age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p0.001), body mass index (OR: 1.06, 95% CI: 1.05-1.08, p0.01), previous cardiac surgery (OR: 0.58, 95% CI: 0.45-0.75, p0.001), and porcelain aorta (OR: 0.66, 95% CI: 0.52-0.85, p = 0.001). Some inter-center variability was observed.We defined 49.4° as the mean AA, and also associated predictors of HA in a large case series of patients with severe aortic stenosis candidates for TAVR.

Significant mitral regurgitation (MR) frequently coexists in patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). These patients have worse clinical outcomes than those with non-significant MR, especially if MR persists after treatment of the aortic stenosis. The optimal treatment approach for this challenging high-risk population is not well defined.This review aims to present the current literature on concomitant significant MR in the TAVR population, and to provide a comprehensive algorithmic approach for clinical decision-making in this challenging cohort of patients.Concomitant mitral and aortic valve disease is a complex clinical entity. An exhaustive and comprehensive assessment of patient's clinical characteristics and mitral valve anatomy and function is required in order to assess the surgical risk, predict the MR response after AVR and evaluate the feasibility of percutaneous MV treatment if necessary. Further developments in transcatheter techniques will expand the indications for double valve treatment in operable and inoperable patients with concomitant significant MR and aortic stenosis.

Tricuspid valve disease, and particularly the management of severe tricuspid regurgitation (TR), has gained momentum in recent years. Although it is well known that this frequent condition is associated with poor clinical outcomes, these patients have been classically managed medically, leading to end-stage right ventricular heart failure. Moreover, late referral to surgery has contributed to a high rate of periprocedural complications and in-hospital surgical mortality. Thus, the development of a less invasive catheter-based therapy would be of high clinical relevance in this context. Several transcatheter tricuspid valve intervention (TTVI) devices have been developed in recent years. The particular characteristics of the tricuspid valve (large noncalcific annulus, presence of chief surrounding structures such as the conduction system or the right coronary artery) make multimodality imaging (eg, transesophageal echocardiography, computed tomography) key in the preprocedural assessment of TTVI. According to their mechanism of action and therapeutic target, TTVI includes transcatheter repair either with coaptation or annuloplasty systems, caval valve devices, and transcatheter tricuspid valve replacement. The initial TTVI experience showed that most procedures were well tolerated, with high procedural success and low in-hospital and early mortality. Also, most TTVI recipients improved their functional status and recent data suggest improved outcomes compared with medical management. However, the rate of significant residual TR after transcatheter tricuspid valve repair remains high and very scarce data exist on longer term (beyond 6-12 months) outcomes. The present review provides an overview regarding the framework of chronic TR and TTVI therapeutic options, and describes the updated current evidence in this challenging field.

The lymphatic system is an integral part of the circulatory system and plays an important role in the volume homeostasis of the human body. The complex anatomy and physiology paired with a lack of simple diagnostic tools to study the lymphatic system have led to an underappreciation of the contribution of the lymphatic system to acute and chronic heart failure (HF). Herein, we discuss the physiological role of the lymphatic system in volume management and the evidence demonstrating the dysregulation of the lymphatic system in HF. Further, we discuss the opportunity to target the lymphatic system in the management of HF and different potential approaches to accessing the lymphatic system.

BACKGROUND Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown. AIMS The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function. METHODS We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE

Background Gastrointestinal bleeding (GIB) is associated with a high recurrence rate and a prior GIB episode is common in real-world left atrial appendage closure (LAAC) recipients. The present study sought to evaluate the clinical characteristics and outcomes of patients with prior GIB undergoing LAAC, and to determine the factors associated with and clinical impact of GIB recurrence. Methods Multicenter study including 277 consecutive patients who underwent percutaneous LAAC and had prior GIB. All-cause death, all bleeding, GIB recurrence, and clinical ischemic stroke were recorded. Results After a median follow-up of 17 (interquartile range: 6-37) months post-LAAC, the rates of death, bleeding, GIB recurrence, and ischemic stroke were 14.0 per 100 person-year (PY), 29.3 per 100 PY, 17.7 per 100 PY, and 1.1 per 100 PY, respectively. GIB recurrence occurred within 3 months post-LAAC in 55.8% of patients. A previous lower GIB (vs. upper or unclassified) (HR: 1.76; 95% CI: 1.09-2.82; p = .020) and eGFR < 45 mL/min (HR: 1.70; 95% CI:1.04-2.67; p = .033) determined an increased risk of GIB recurrence. By multivariable analysis, eGFR < 45 mL/min (HR: 2.72; 95% CI: 1.70-4.34; p < .001), GIB recurrence following LAAC (HR: 2.15; 95% CI: 1.33-3.46; p = .002), diabetes mellitus (HR: 1.77; 95% CI: 1.10-2.84; p = .018), and age (HR: 1.06; 95% CI: 1.03-1.10; p < .001) were associated with an increased mortality. Conclusions Patients with prior GIB undergoing LAAC exhibited a relatively low rate of GIB recurrence, and prior lower GIB and moderate-to-severe chronic kidney disease determined an increased risk. GIB recurrence was associated with an increased mortality.

Mitral regurgitation (MR) is the most prevalent valvular heart disease and, when left untreated, it confers a poorer prognosis. Catheter-based repair therapies face some limitations like their applicability on challenging anatomies and the potential recurrence of significant MR over time. Transcatheter mitral valve replacement (TMVR) has emerged as a less invasive approach potentially overcoming some of the current limitations associated with transcatheter mitral valve repair. Several devices are under clinical investigation, and a growing number of systems allow for a fully percutaneous transfemoral approach. In this review, the authors aimed to delineate the main challenges faced by the TMVR field, to highlight the key aspects for procedural planning, and to describe the clinical results of the TMVR systems under clinical investigation. Finally, they also discuss what the future perspectives are for this emerging field.

Background: Biological data suggest that short-term anticoagulation would be more effective than dual antiplate -let therapy (DAPT) to reduce the thrombotic risk following left atrial appendage closure (LAAC). This study sought to assess the safety and efficacy of direct oral anticoagulation (DOAC) versus DAPT immediately post-LAAC. Methods: Multicenter study including 592 consecutive patients with relative contraindication to chronic anticoagulation who underwent LAAC and received either DAPT or DOAC for 1-3 months. Each patient receiving DOAC was matched with 2 patients on DAPT based on propensity-score (propensity-matched population of 285 patients). Outcomes recorded were death, stroke, non-procedural related severe bleeding, serious adverse event (SAE: composite of death, stroke, bleeding) and early (within 3 months post-LAAC) device-related thrombosis (DRT). Results: Early outcomes (within 3-month post-LAAC) did not significantly differ between groups, but a numeri-cally higher rate of early death (3.7% vs. 1.1%), non-procedural related severe bleeding (7.4% vs. 3.2%), and SAE (11.1% vs. 5.3%) were observed in patients receiving DAPT. After a median follow-up of 22 (8-38) months, similar outcomes were observed in DAPT and DOAC groups regarding death (HR: 1.18; 95% CI: 0.58-2.37; p = 0.652), stroke (HR: 1.01; 95% CI: 0.22-5.45; p = 0.908), non-procedural related severe bleeding (HR: 1.68; 95% CI: 0.69-4.12; p = 0.257), and SAE (HR: 1.28; 95% CI: 0.73-2.24; p = 0.383). DRT was identified in 4 patients (2.6%) receiving DAPT versus 0 patient receiving DOAC (p = 0.162). Conclusions: Short-term DOAC following LAAC in patients with contraindications to chronic anticoagulation was safe and tended to associate with a lower rate of SAE and DRT compared to DAPT. (c) 2021 Elsevier B.V. All rights reserved.

Background Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). Objectives The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. Methods Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. Results A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). Conclusions In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

Background: Patients with low left ventricular ejection fraction (LVEF), low-flow, low-gradient (i.e. classical low flow [CLF]) aortic stenosis (AS) have a dismal short-term outcome without aortic ...

We herein present clinical images illustrating a transcatheter aortic valve implantation within an extremely calcified aortic valve, which posed considerable difficulty in crossing the aortic annulus. To gain maximum support, we used 2 buddy wires to allow a balloon predilation and then a successful crossing of the transcatheter heart valve. This technique provides additional support for those performing this procedure and may be included in the armamentarium of transcatheter aortic valve specialists.

Resumen Introduccion y objetivos Evaluar la hemodinamica valvular a largo plazo de las valvulas percutaneas (VCP), y determinar la incidencia, las caracteristicas y los factores asociados con la degeneracion estructural valvular (DEV). Metodos Se incluyo a 212 pacientes a los que se realizo un implante percutaneo de valvula aortica. Todos los pacientes tenian un seguimiento potencial minimo de 5 anos y al menos 1 examen de ecocardiografia transtoracica (ETT) al menos 1 ano tras el procedimiento. Todos los pacientes tuvieron una ETT a 1-5 anos y 36, una segunda ETT a los 6-10 anos. La DEV se definio como subclinica y clinicamente relevante. A 15 pacientes se les realizo una ecocardiografia transesofagica en el momento del diagnostico de DEV y 85 tuvieron una evaluacion por tomografia computarizada tras 1 (0,5-2) ano. Resultados Se observo un aumento del gradiente valvular y una disminucion gradual del area valvular (p Conclusiones Los resultados de este estudio demuestran un deterioro progresivo (en un periodo de hasta 10 anos) de la hemodinamica de las VCP aorticas, con una tasa de DEV de cerca del 30% (clinicamente relevante en

We assessed the long-term hemodynamic performance of transcatheter heart valve (THV) by paired transthoracic echocardiography (TTE), and the incidence, characteristics and factors associated with THV structural valve degeneration (SVD).A total of 212 patients who underwent transcatheter aortic valve replacement and had a potential follow-up5 years with at least 1 TTE ≥ 1-year postprocedure were included. All patients had a TTE at 1 to 5 years and 36 had another one at 6 to 10 years. SVD was defined as subclinical (increase10mmHg in mean transvalvular gradient+decrease0.3cmTransvalvular mean gradient increased and valve area decreased over time (P.01). At 8 years of follow-up, SVD occurred in 30.2% of patients (clinically relevant: 9.3%). Transesophageal echocardiography revealed thickened and reduced-mobility leaflets in 80% and 73% of SVD cases, respectively. No baseline or procedural factors were associated with SVD. THV underexpansion (3.5%) or eccentricity (8.2%) had no impact on valve hemodynamics/SVD at follow-up.A gradual THV hemodynamic deterioration occurred throughout a 10-year period, leading to SVD in ∼30% of patients (clinically relevant in10%). Leaflet morphology/mobility were frequently impaired in SVD cases, but THV geometry did not influence valve hemodynamics or SVD.

Background Transcarotid transcatheter aortic valve replacement (TAVR) recipients may be exposed to a higher ipsilateral subclinical cerebral ischemic burden compared with the contralateral hemisphere. We sought (1) to compare the cerebral ischemic burden of the 2 hemispheres after transcarotid TAVR, as evaluated by diffusion weighted-magnetic resonance imaging (DW-MRI), and (2) to identify the factors associated with ipsilateral ischemic burden. Methods This prospective study included 52 patients undergoing transcarotid TAVR, followed by a DW-MRI examination. All DW-MRIs were analyzed offline by a radiologist blinded to the clinical data. Results TAVR was performed through the left (n = 50) or right (n = 2) carotid artery. Procedural success was achieved in all patients, carotid dissection requiring patch closure occurred in 1 patient, and there were no periprocedural stroke events. At least 1 cerebral ischemic lesion was identified in the ipsilateral and contralateral hemisphere in 84.6% and 63.5% of patients, respectively (P = .005), and the number of ischemic lesions per patient was higher in the ipsilateral vs the contralateral hemisphere (2 [interquartile range, 1-5] vs 1 [interquartile range, 0-3], P = .005). The lesion volume (per lesion) and the average lesion volume (per patient) did not differ between the 2 hemispheres. A larger sheath/catheter size (≥18F vs ≤16F) was associated with a higher ipsilateral ischemic burden (P = .026). Conclusions Carotid artery access for TAVR was associated with a higher number of cerebral ischemic lesions in the ipsilateral (vs contralateral) cerebral hemisphere. The use of a larger sheath/delivery system (≥18F) was associated with an increased ipsilateral ischemic burden.

Transcatheter aortic valve replacement (TAVR) has changed the treatment of patients with severe aortic stenosis. However, the occurrence of conduction disturbances has not decreased significantly over time and remains the main drawback of the procedure. In addition, new-onset atrial fibrillation is the most frequent tachyarrhythmia during the hospitalization period and is associated with worse clinical outcomes. However, little is known regarding the incidence and clinical impact of arrhythmic events beyond the periprocedural TAVR period. Ambulatory electrocardiogram (AECG) monitoring has recently emerged as a tool to unravel the complex issue of arrhythmic disorders (bradyarrhythmias and tachyarrhythmias) before and after TAVR. To date, the preliminary results from the initial experience using AECG monitoring systems showed the safety, usefulness, and potential clinical implications of this diagnostic tool in TAVR recipients. This review provides an overview of the current status, clinical implications, and future perspectives of AECG monitoring in the TAVR setting.

Background Management of aortic stenosis (AS) relies on symptoms. Exercise testing is recommended for asymptomatic patients with significant AS but is often experienced as forbidding and/or technically unrealistic for patients who are often frail, deconditioned, and intimidated by the exercise test. We compared the physiological burden assessed with gas exchange assessments to gauge and respiratory exchange ratio (RER) of a 6-minute walk test (6MWT) to a cardiopulmonary exercise stress test (CPET) in patients with severe AS. peak oxygen utilization Methods Adults with equivocal symptoms and severe AS (1-aortic valve area [AVA] ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2, 2-peak aortic jet velocity ≥ 4.0 m/sec, 3-mean transvalvular pressure gradient ≥ 40 mm Hg by rest or dobutamine stress echocardiography, or 4-aortic valve calcification ≥ 1200 in women or ≥ 2000 AU in men) were studied. All participants completed both a 6MWT and symptom-limited progressive bicycle exercise testing. Breath-by-breath gas analysis and 12-lead electrocardiography were completed during 6MWT and CPET. Results: Eleven patients were studied. Patients walked on average 330 ± 75 m during the 6MWT and achieved a maximal workload of 48 ± 14 watts during the CPET. During the 6MWT, peak maximal oxygen uptake ( V ˙ O2peak) was 12.8 ± 2.5 vs 10.8 ± 4.2 mL/kg/min during the CPET. Respiratory exchange ratio exceeded 1.1 in both the 6MWT and CPET indicating similarly high exertion. Compared with the CPET, a larger proportion of the 6MWT was performed at a high intensity level (78% ± 28% vs 33% ± 24% at > 85% VO2peak; P = 0.004). Conclusions The 6MWT with breath-by-breath gas analysis was well tolerated and able to achieve a physiological intense RER and V ˙ O2peak that are similar to symptom-limited CPET in patients with severe AS.

Recent randomized trials including low-risk patients showed positive results for transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR), but patients with non-tricuspid aortic valve (NTAV), severe coronary artery disease (SevCAD), and those requiring concomitant mitral/tricuspid valve (CMTV) or concomitant ascending aorta replacement (CAAR) interventions were excluded.This study sought to evaluate the presence and impact of the main clinical variables not evaluated in TAVR versus SAVR trials (NTAV, SevCAD, and CMTV or CAAR intervention) in a large series of consecutive low-risk patients with severe aortic stenosis (SAS) undergoing SAVR.Single-center study including consecutive patients with SAS and low surgical risk (Society of Thoracic Surgeons score of 4%) undergoing SAVR. Baseline, procedural characteristics, and 30-day outcomes were prospectively collected.Of 6,772 patients with SAS who underwent SAVR between 2000 and 2019, 5,310 (78.4%) exhibited a low surgical risk (mean Society of Thoracic Surgeons score: 1.94 ± 0.87%). Of these, 2,165 patients (40.8%) had at least 1 of the following: NTAV (n = 1,468, 27.6%), SevCAD (n = 307, 5.8%), CMTV (n = 306, 5.8%), and CAAR (n = 560, 10.5%). The 30-day mortality and stroke rates for the overall low-risk SAS cohort were 1.9% and 2.4%, respectively. The mortality rate was similar in the SevCAD (2.6%) and CAAR (2.1%) groups versus the rest of the cohort (odds ratio [OR]: 1.79; 95% confidence interval [CI]: 0.85 to 3.75, and OR: 1.64; 95% CI: 0.88 to 3.05, respectively), lower in the NTAV group (0.9%; OR: 0.42; 95% CI: 0.22 to 0.81), and higher in the CMTV group (5.9%; OR: 2.61; 95% CI: 1.51 to 4.5).In a real-world setting, close to one-half of the low-risk patients with SAS undergoing SAVR exhibited at least 1 major criterion not evaluated in TAVR versus SAVR randomized trials. Clinical outcomes were better than or similar to those predicted by surgical scores in all groups but those patients requiring CMTV intervention. These results may help determine the impact of implementing the results of TAVR-SAVR trials in real practice and may inform future trials in specific groups.

The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk.Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality.Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected.At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events.Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy.

Background: Transcatheter aortic valve replacement (TAVR) has been shown to be a good alternative to surgery for treating severe symptomatic aortic stenosis (AS) across the whole range of surgical risk patients. Whereas most periprocedural TAVR complications have significantly decreased over time, conduction disturbances remain high. Approaches to decrease this shortcoming are under continuous investigation. Methods: We conducted a comprehensive systematic review focusing on modifiable factors impacting post-TAVR conduction disturbances, such as balloon aortic valvuloplasty (BAV), type of new-generation transcatheter valve and implantation depth (ID). Search strategies were based on the best available evidence from each study. Primary endpoints were post-TAVR need of permanent pacemaker implantation (PPI) and new onset left bundle branch block (NOLBBB). Results: Data from 35 studies with a total of 29,982 patients were analyzed. BAV did not negatively impact PPI rates after TAVR. In propensity-matched and randomized trials, the Evolut R valve was associated with slightly higher rates of PPI compared to the Sapien 3 valve (25% vs . 19.2% in propensity-matched studies; 22.9% vs . 19% in a randomized trial). The Acurate Neo valve was associated with the lowest PPI rate in observational studies (10.4%), but a PPI rate similar to Sapien 3 was reported in a randomized trial (10% vs . 9%). The Portico valve system was associated with a higher PPI risk (PPI rate of 21.9% and 27.7% in propensity-matched and randomized studies, respectively). ID and its relation with the membranous septum (MS) length predicted post-TAVR conduction disturbances, particularly with Evolut R and Sapien 3 valves. Conclusions: Pre-TAVR BAV did not increase the risk of conduction disturbances post-TAVR. Among the new-generation transcatheter valve systems, Sapien 3 and Acurate Neo valves were associated with the lowest PPI rates followed by the Evolut and Portico valves. A deeper valve implantation and a shorter MS length determined an increased risk of conduction disturbances post-TAVR.

espanolEl tratamiento antitrombotico tras el implante percutaneo de valvula aortica (TAVI) ha evolucionado empiricamente, y en la actualidad en las guias clinicas se recomienda el tratamiento antiagregante plaquetario doble (TAPD, acido acetilsalicilico mas clopidogrel). El ensayo piloto ARTE mostro un mayor riesgo de episodios hemorragicos graves o potencialmente mortales y ninguna disminucion de las complicaciones tromboembolicas con el uso de TAPD frente a acido acetilsalicilico solo en los pacientes receptores de TAVI. El ensayo POPular TAVI recientemente publicado (NCT02247128) ha confirmado los efectos negativos del TAPD (en comparacion con el acido acetilsalicilico solo) tras TAVI, que se asocio con un aumento significativo de todos los eventos hemorragicos (objetivo principal) y ninguna disminucion de los eventos isquemicos (accidente cerebrovascular, infarto de miocardio) ni de las muertes. Ademas, el TAPD no tuvo ningun efecto sobre la aparicion de trombosis valvular clinicamente aparente. Si bien los estudios en curso y futuros determinaran el posible papel de la anticoagulacion (frente a la antiagregacion plaquetaria) como tratamiento antitrombotico tras TAVI, la evidencia actual apoya firmemente el uso del tratamiento antiagregante plaquetario unico (acido acetilsalicilico) en este contexto. Por lo tanto, en la practica clinica habitual del TAVI se debe adoptar con urgencia un enfoque minimalista con acido acetilsalicilico solo, e implementarlo en las guias de practica clinica. EnglishAntithrombotic therapy following transcatheter aortic valve implantation (TAVI) has evolved empirically with dual antiplatelet therapy (DAPT, aspirin plus clopidogrel) currently recommended in the clinical guidelines. The pilot ARTE trial showed a higher risk of major/life-threatening bleeding events and no reduction of thromboembolic complications with the use of DAPT vs aspirin alone in TAVI recipients. The recently published POPular TAVI trial (NCT02247128) confirmed an increased risk of DAPT (vs. aspirin alone) following TAVI, which was associated with a significant increase in all bleeding events (primary endpoint) and no reduction of ischemic events (stroke, myocardial infarction) or death. Also, DAPT had no effects on the occurrence of clinically apparent valve thrombosis. While ongoing and future studies will have to determine the potential role of anticoagulation (vs antiplatelet) therapy as the antithrombotic treatment of TAVI, the evidence currently available strongly supports the use of single antiplatelet therapy (aspirin) in this setting. Thus, a minimalist approach with aspirin alone should urgently be adopted in the TAVI routine clinical practice and, therefore, implemented in the guidelines.

Aims The objective was to compare the incidence and impact on outcomes of measured (PPMM) vs. predicted (PPMP) prosthesis–patient mismatch following transcatheter aortic valve replacement (TAVR). Methods and results All consecutives patients who underwent TAVR between 2007 and 2018 were included. Effective orifice area (EOA) was measured by Doppler-echocardiography using the continuity equation and predicted according to the normal reference for each model and size of valve. PPM was defined using EOA indexed (EOAi) to body surface area as moderate if ≤0.85 cm2/m2 and severe if ≤ 0.65 cm2/m2 (respectively, ≤ 0.70 and ≤ 0.55 cm2/m2 if body mass index ≥ 30 kg/m2). The outcome endpoints were high residual gradient (≥20 mmHg) and the composite of cardiovascular mortality and hospital readmission for heart failure at 1 year. Overall, 1088 patients underwent a TAVR (55% male, age 79.1 ± 8.4 years, and STS score 6.6 ± 4.7%); balloon-expandable device was used in 83%. Incidence of moderate (10% vs. 27%) and severe (1% vs. 17%) PPM was markedly lower when defined by predicted vs. measured EOAi (P Conclusion The utilization of the predicted EOAi reclassifies the majority of patients with PPM to no PPM following TAVR. Compared with measured PPM, predicted PPM had stronger association with haemodynamic outcomes, while both methods were not associated with clinical outcomes.

AimsThis study sought to determine the timing and evolution over time of advanced conduction disturbances (CDs) in patients with baseline right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR).Methods and resultsOne hundred and ten consecutive patients with pre-existing RBBB were included (out of 1341, 8.2%). All arrhythmias during the hospitalization period were recorded. Follow-up was performed at 30 days, 1 year, and yearly thereafter. Conduction recovery and ventricular pacing percentage (VPP) was evaluated at 30 days in those patients with permanent pacemaker implantation (PPMI). Sixty-one (55.5%) patients suffered advanced CDs [97% complete or high-degree atrioventricular block (CHB/HAVB)], and the vast majority (98%) occurred within the first 3 days post-procedure (intraprocedural: 85%). Fifty-two (47.3%) patients had PPMI (vs. 11.0% in non-RBBB patients, P ConclusionIn patients with pre-existing RBBB, the vast majority of advanced CDs occurred within the 3 days following TAVR, and most did not recover at 1-month, particularly those with intra-procedural persistent CHB/HAVB. These results should help to determine the hospitalization length and timing of PPMI in RBBB patients undergoing TAVR.

In the COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial, angiography-guided percutaneous coronary intervention (PCI) of nonculprit lesions with the aim of complete revascularization reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (MI) and multivessel coronary artery disease.The purpose of this study was to determine the effect of nonculprit-lesion stenosis severity measured by quantitative coronary angiography (QCA) on the benefit of complete revascularization.Among 4,041 patients randomized in the COMPLETE trial, nonculprit lesion stenosis severity was measured using QCA in the angiographic core laboratory in 3,851 patients with 5,355 nonculprit lesions. In pre-specified analyses, the treatment effect in patients with QCA stenosis ≥60% versus 60% on the first coprimary outcome of CV death or new MI and the second co-primary outcome of CV death, new MI, or ischemia-driven revascularization was determined.The first coprimary outcome was reduced with complete revascularization in the 2,479 patients with QCA stenosis ≥60% (2.5%/year vs. 4.2%/year; hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.47 to 0.79), but not in the 1,372 patients with QCA stenosis 60% (3.0%/year vs. 2.9%/year; HR: 1.04; 95% CI: 0.72 to 1.50; interaction p = 0.02). The second coprimary outcome was reduced in patients with QCA stenosis ≥60% (2.9%/year vs. 6.9%/year; HR: 0.43; 95% CI: 0.34 to 0.54) to a greater extent than patients with QCA stenosis 60% (3.3%/year vs. 5.2%/year; HR: 0.65; 95% CI: 0.47 to 0.89; interaction p = 0.04).Among patients with ST-segment elevation MI and multivessel coronary artery disease, complete revascularization reduced major CV outcomes to a greater extent in patients with stenosis severity of ≥60% compared with 60%, as determined by quantitative coronary angiography.

Objectives This study sought to determine, using continuous electrocardiographic monitoring (CEM) pre–transcatheter aortic valve replacement (TAVR), the incidence and type of unknown pre-existing arrhythmic events (AEs) in TAVR candidates, and to evaluate the occurrence and impact of therapeutic changes secondary to the detection of AEs pre-TAVR. Background Scarce data exist on the arrhythmic burden of TAVR candidates (pre-procedure). Methods This was a prospective study including 106 patients with severe aortic stenosis and no prior permanent pacemaker screened for TAVR. A prolonged (1 week) CEM was implanted within the 3 months pre-TAVR. Following heart team evaluation, 90 patients underwent elective TAVR. Results New AEs were detected by CEM in 51 (48.1%) patients, leading to a treatment change in 14 of 51 (27.5%) patients. Atrial fibrillation or tachycardia was detected in 8 of 79 (10.1%) patients without known atrial fibrillation or tachycardia, and nonsustained ventricular arrhythmias were detected in 31 (29.2%) patients. Significant bradyarrhythmias were observed in 22 (20.8%) patients, leading to treatment change and permanent pacemaker in 8 of 22 (36.4%) and 4 of 22 (18.2%) patients, respectively. The detection of bradyarrhythmias increased up to 30% and 47% among those patients with pre-existing first-degree atrioventricular block and right bundle branch block, respectively. Chronic renal failure, higher valve calcification, and left ventricular dysfunction determined (or tended to determine) an increased risk of AEs pre-TAVR (p = 0.028, 0.052, and 0.069, respectively). New onset AEs post-TAVR occurred in 22.1% of patients, and CEM pre-TAVR allowed early arrhythmia diagnosis in one-third of them. Conclusions Prolonged CEM in TAVR candidates allowed identification of previously unknown AEs in nearly one-half of the patients, leading to prompt therapeutic measures (pre-TAVR) in about one-fourth of them. Pre-existing conduction disturbances (particularly right bundle branch block) and chronic renal failure were associated with a higher burden of AEs.

In patients with severe mitral regurgitation (MR), transcatheter mitral valve replacement (TMVR) has recently emerged as an alternative to surgery. However, compared with transcatheter aortic valve replacement, TMVR faces several technical challenges and a high screening failure rate, mainly due to a more complex mitral annulus geometry and the potential interaction with the sub-valvular apparatus and the left ventricular outflow tract (LVOT). The AltaValve system is a device intended for TMVR with unique design features that may overcome most anatomical limitations for this therapy.A summary of the current evidence regarding TMVR is presented, followed by a review of the main technical challenges. The main features, differential characteristics, and potential advantages of the AltaValve system are discussed. Finally, we describe the first-in-human procedures with AltaValve and the main details of the upcoming feasibility trial.A high number of high-risk surgical patients with MR remain undertreated. TMVR is continuously evolving, and AltaValve constitutes another step forward in this field. Its unique design avoiding annular and LVOT engagement represents a clear potential benefit, along with its recently incorporated trans-septal approach system. However, more evidence is warranted regarding its feasibility in different clinical settings and mid-term performance.

Background There has been an exponential increase in the demand for transcatheter aortic valve replacement (TAVR). Our goal was to examine trends in TAVR capacity and wait-times across Canada. Methods All TAVR cases were identified from April 1, 2014, to March 31, 2017. Wait-time was defined as the duration in days from the initial referral to the TAVR procedure. TAVR capacity was defined as the number of TAVR procedures per million population/province/fiscal year. We performed multivariable multilevel Cox proportional hazards modelling of the time to TAVR as the dependant variable and the effect of provinces as random effects. We quantified the variation in wait-times among provinces using the median hazard ratio. Results We identified a total of 4906 TAVR procedures across 9 provinces. Despite a year over year increase in overall capacity, there was a greater than 3-fold difference in capacity between provinces. Crude median wait-times increased over time in all provinces, with marked variation from 71.5 days in Newfoundland to 190.5 and 203 days in Manitoba and Alberta, respectively. This suggests increasing demand outpaced the growth in capacity. We found a median hazard ratio of 1.62, indicating that in half of the possible pairwise comparisons, the time to TAVR for identical patients was at least 62% longer between different provinces. Conclusion We found substantial geographic inequity in TAVR access. This calls for policy makers, clinicians, and administrators across Canada to address this inequity through revaluation of provincial funding mechanisms, as well as implementation of efficient care pathways.

Background Despite the widespread use of transesophageal echocardiography (TEE) to guide structural cardiac interventions, studies evaluating safety in this context are lacking. Objectives This study sought to determine the incidence, types of complications, and factors associated with esophageal or gastric lesions following TEE manipulation during structural cardiac interventions. Methods This was a prospective study including 50 patients undergoing structural cardiac interventions in which TEE played a central role in guiding the procedure (mitral and tricuspid valve repair, left atrial appendage closure, and paravalvular leak closure). An esophagogastroduodenoscopy (EGD) was performed before and immediately after the procedure to look for new injuries that might have arisen during the course of the intervention. Patients were divided in 2 cohorts according to the type of injury: complex lesions (intramural hematoma, mucosal laceration) and minor lesions (petechiae, ecchymosis). The factors associated with an increased risk of complications were assessed. Results Post-procedural EGD showed a new injury in 86% (n = 43 of 50) of patients, with complex lesions accounting for 40% (n = 20 of 50) of cases. Patients with complex lesions presented more frequently with an abnormal baseline EGD (70% vs. 37%; p = 0.04) and had a higher incidence of post-procedural dysphagia or odynophagia (40% vs. 10%; p = 0.02). Independent factors associated with an increased risk of complex lesions were a longer procedural time under TEE manipulation (for each 10-min increment in imaging time, odds ratio: 1.27; 95% confidence interval: 1.01 to 1.59) and poor or suboptimal image quality (odds ratio: 4.93; 95% confidence interval: 1.10 to 22.02). Conclusions Most patients undergoing structural cardiac interventions showed some form of injury associated with TEE, with longer procedural time and poor or suboptimal image quality determining an increased risk. Imaging experts performing this technique should be aware of the nature of potential complications, to take the necessary precautions to prevent their occurrence and facilitate early diagnosis and treatment.

Aortic valve calcification severity has been associated with higher rates of aortic regurgitation (AR) following TAVR, but scarce data exist on its impact with the use of newer generation transcatheter heart valves.This was a multicenter study including 626 patients with severe aortic stenosis who underwent TAVR with the SAPIEN 3 valve. Patients were divided in 2 groups according to the median index calcium score (iCS) for each sex: high CS (HCS, iCS ≥ median), and low iCS (LCS, iCS median). Another analysis was performed in those patients with extreme iCS (ECS, iCS75th percentile for each sex). Clinical and echocardiographic data were collected prospectively in a dedicated database.The mean CS was 3758 ± 1417 AU and 1616 ± 691 AU in the HCS and LCS groups, respectively (p 0.001). There were no differences between groups in 30-day mortality (HCS:2.6%, LCS:1.0%, p = 0.13) and stroke (HCS:2.6%,LCS:2.6%, p = 1.0) rates, but all cases (n = 5) of annulus rupture occurred in the HCS group (1.6% vs. 0%, p = 0.061). The incidence of moderate-severe AR post-TAVR was low in both groups (HCS:1.6%,LCS:1.6%, p = 1.0), and valve gradient and area were similar between groups. The results remained similar in the ECS group (mean CS:4607 ± 1424 AU), but a mildly increased mean transvalvular gradient post-TAVR was observed in ECS patients (12.1 ± 5.6 vs 11.0 ± 4.3 mmHg; p = 0.015).Aortic valve calcification severity failed to impact mortality/stroke rates following TAVR with the SAPIEN 3 valve. Low rates of significant AR were observed irrespective of CS, and a mild increase in transvalvular gradient was observed in ECS patients.

Objectives Our study reports the first-in-human experience of a novel approach for left atrial access via the coronary sinus—the percutaneous atriotomy—which is used for left atrial decomp...

Background Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. Objectives The authors sought to examine outcomes following redo-TAVR. Methods The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. Results Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. Conclusions Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

Objectives This study sought to determine the incidence, clinical impact, and changes over time of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). Background Few data exist on the clinical impact and changes in severity over time of MR in patients with LFLG-AS undergoing TAVR. Methods A total of 308 TAVR candidates with LFLG-AS were included. Patients were categorized according to MR severity at baseline, and presence of MR improvement at 12-month follow-up. Clinical outcomes were assessed at 1 and 12 months (+ echocardiography), and yearly thereafter. Results Baseline mild and moderate-to-severe MR were present in 118 (38.3%) and 115 (37.3%) patients, respectively. MR was of functional and mixed etiology in 77.2% and 22.7% of patients, respectively. A total of 131 patients (42.5%) died after a median follow-up of 2 (1 to 3) years. Baseline moderate-or-greater MR had no impact on mortality (hazard ratio [HR]: 1.34; 95% confidence interval [CI]: 0.72 to 2.48) or heart failure hospitalization (HR: 1.02; 95% CI: 0.49 to 2.10). At 1-year follow-up, MR improved in 44.3% of patients and remained unchanged/worsened in 55.7%. The lack of MR improvement was associated with a higher risk of all-cause and cardiac mortality (HR: 2.02; 95% CI: 1.29 to 3.17; HR: 3.03; 95% CI: 1.27 to 7.23, respectively), rehospitalization for cardiac causes (HR: 1.50; 95% CI: 1.04 to 2.15), and an increased overall-mortality/heart failure rehospitalization (HR: 1.94; 95% CI: 1.25 to 3.02). A higher baseline left ventricular end-diastolic diameter and a higher increase in left ventricular ejection fraction were found to be independent predictors of MR improvement at 1-year follow-up (odds ratio: 0.69; 95% CI: 0.51 to 0.94; and odds ratio: 0.81; 95% CI: 0.67 to 0.96, respectively). Conclusions Most TAVR candidates with LFLG-AS had some degree of MR, of functional origin in most cases. MR improved in about one-half of patients, with larger left ventricular size and a higher increase in left ventricular ejection fraction post-TAVR determining MR improvement over time. The lack of MR improvement at 1 year was associated with poorer outcomes.

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively. The patients had a clinical visit and 12-lead ECG at 1-year follow-up. LBBB recovery was observed in 50 patients (33%), and 14 patients (9%) had advanced conduction disturbances requiring PPI during the follow-up period. No clinical or ECG variables were associated with LBBB recovery, including prosthesis type (self- or balloon-expandable valve, p = 0.563), QRS width at baseline/discharge or absolute/relative ΔQRS (p >0.10 for all). The presence of atrial fibrillation at baseline (0.026), a longer PR interval at discharge (0.009), and a longer absolute and relative ΔPR (p = 0.002 and p = 0.004, respectively) were associated with an increased risk of PPI at 1-year follow-up. In conclusion, NOP-LBBB post-TAVI resolved in one-third of patients at 1-year follow-up, but no clinical or ECG variables were associated with LBBB recovery. Conversely, a nonsinus rhythm at baseline and a longer ΔPR were associated with an increased risk of PPI within the year after TAVI.

Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged60 years.Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged60 years (mean, 66±5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44±10 years).Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269).In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF.

Resumen Introduccion y objetivos Estudios aleatorizados han mostrado la eficacia del cierre percutaneo del foramen oval permeable (FOP) en pacientes de edad ≤ 60 anos con ictus criptogenico. El objetivo de este estudio es determinar la seguridad y la eficacia a largo plazo del cierre percutaneo del FOP en pacientes mayores de 60 anos con ictus criptogenico. Metodos De 475 pacientes consecutivos con ictus criptogenico que se sometieron al cierre del FOP, 90 eran mayores de 60 anos (media, 66 ± 5 anos) y se los comparo con los 385 del grupo de edad ≤ 60 anos (media, 44 ± 10 anos). Resultados Los pacientes mayores de 60 anos tuvieron mayor prevalencia de factores de riesgo cardiovascular (FRCV) (hipertension, dislipemia y diabetes; p Conclusiones El cierre percutaneo del FOP en pacientes mayores de 60 anos con ictus criptogenico resulto seguro y se asocio con una baja incidencia de eventos isquemicos a largo plazo. Sin embargo, en los pacientes mayores de 60 anos se observo una tendencia a mayor incidencia de ictus/AIT probablemente relacionada con mayor prevalencia de FRCV.

Objectives The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. Background Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. Methods The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. Results Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). Conclusions TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

Initially, transcatheter aortic valve replacement (TAVR) was only used in patients with severe symptomatic aortic stenosis and prohibitive risk for surgical aortic valve replacement. Subsequently, TAVR was extended to patients with high and intermediate surgical risk. Recently, the results of randomized trials in low-surgical-risk patients showed superiority or noninferiority of TAVR versus surgical aortic valve replacement in this population. Procedural outcomes have been improved. Long-term durability of transcatheter heart valves remains to be confirmed. This article presents the evolution and current status of TAVR, with respect to the different types of devices and procedures as well as its outcomes.

International audience; Background - Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). Methods - Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. Results - SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038). Conclusions - SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.

ObjectiveLeft atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus.MethodsThis multicentre observational registry included 126 consecutive patients referred for LAAC with LAA thrombus on preprocedural imaging. Treatment strategies included intensification of antithrombotic therapy (IAT) or direct LAAC. The primary and secondary endpoints were a composite of bleeding, stroke and death at 18 months, and procedural success, respectively.ResultsIAT was the preferred strategy in 57.9% of patients, with total thrombus resolution observed in 60.3% and 75.3% after initial and subsequent IAT, respectively. Bleeding complications and stroke during IAT occurred in 9.6% and 2.9%, respectively, compared with 3.8% bleeding and no embolic events in the direct LAAC group before the procedure. Procedural success was 90.5% (96.2% vs 86.3% in direct LAAC and IAT group, respectively, p=0.072), without cases of in-hospital thromboembolic complications. The primary endpoint occurred in 29.3% and device-related thrombosis was found in 12.8%, without significant difference according to treatment strategy. Bleeding complications at 18 months occurred in 22.5% vs 10.5% in the IAT and direct LAAC group, respectively (p=0.102).ConclusionIn the presence of LAA thrombus, IAT was the initial management strategy in half of our cohort, with initial thrombus resolution in 60% of these, but with a relatively high bleeding rate (~10%). Direct LAAC was feasible, with high procedural success and absence of periprocedural embolic complications. However, a high rate of device-related thrombosis was detected during follow-up.