International Observational Analysis of Evolution and Outcomes of Chronic Stable Angina: The Multinational CLARIFY Study.

BACKGROUND: Although angina is common in patients with stable coronary artery disease, limited data are available on its prevalence, natural evolution, and outcomes in the era of effective cardiovascular drugs and widespread use of coronary revascularization. METHODS: Using data from 32 691 patients with stable coronary artery disease from the prospective observational CLARIFY registry (Prospective Observational Longitudinal Registry of Patients with Stable Coronary Artery Disease), anginal status was mapped each year in patients without new coronary revascularization or new myocardial infarction. The use of medical interventions in the year preceding angina resolution was explored. The effect of 1-year changes in angina status on 5-year outcomes was analyzed using multivariable analysis. RESULTS: Among 7212 (22.1%) patients who reported angina at baseline, angina disappeared (without coronary revascularization) in 39.6% at 1 year, with further annual decreases. In patients without angina at baseline, 2.0% to 4.8% developed angina each year. During 5-year follow-up, angina was controlled in 7773 patients, in whom resolution of angina was obtained with increased use of antianginal treatment in 11.1%, with coronary revascularization in 4.5%, and without any changes in medication or revascularization in 84.4%. Compared to patients without angina at baseline and 1 year, persistence of angina and occurrence of angina at 1 year with conservative management were each independently associated with higher rates of cardiovascular death or myocardial infarction (adjusted hazard ratio, 1.32 [95% CI, 1.12-1.55] for persistence of angina; adjusted hazard ratio, 1.37 [95% CI, 1.11-1.70] for occurrence of angina) at 5 years. Patients whose angina had resolved at 1 year with conservative management were not at higher risk of cardiovascular death or myocardial infarction than those who never experienced angina (adjusted hazard ratio, 0.97 [95% CI, 0.82-1.15]). CONCLUSIONS: Angina affects almost one-quarter of patients with stable coronary artery disease but resolves without events or coronary revascularization in most patients. Resolution of angina within 1 year with conservative management predicted outcomes similar to lack of angina, whereas persistence or occurrence was associated with worse outcomes. Because most patients with angina are likely to experience resolution of symptoms, and because there is no demonstrated outcome benefit to routine revascularization, this study emphasizes the value of conservative management of stable coronary artery disease. Registration: URL: https://www.isrctn.com; Unique identifier: ISRCTN43070564.

Percutaneous Coronary Intervention Pre-TAVR: Current State of the Evidence.

PURPOSE OF REVIEW: This review intends to give an up-to-date overview of the current state of evidence in the treatment of coronary artery disease (CAD) in patients undergoing transcatheter aortic valve replacement (TAVR), focusing on percutaneous coronary interventions (PCI) pre-TAVR. RECENT FINDINGS: The recently published ACTIVATION trial is the 1st randomized trial comparing coronary revascularization (PCI) versus medical treatment in patients with significant CAD undergoing TAVR. With the caveat of several major limitations of the trial, the results of this study raised the question about the appropriateness of the common practice to routinely revascularize coronary stenosis before TAVR. Aortic valve stenosis is the most common valvular heart disease among the elderly and it often co-occurs with CAD. TAVR is increasingly considered an alternative to surgical aortic valve replacement not only in the elderly population but also in younger and lower-risk patients. The impact of co-existing CAD on clinical outcomes as well as the optimal timing of PCI in TAVR candidates is still unclear and the subject of ongoing randomized trials. Meanwhile, it is common practice in many centers to routinely perform invasive coronary angiography and PCI for significant coronary disease as part of the TAVR workup. While computed tomography angiography has emerged as a possible alternative to the invasive coronary angiography in patients with low pre-test probability for CAD, the value of functional invasive assessment of coronary lesions in the pre-TAVR setting has still to be clarified. Also, there is an increasing interest in the clinical relevance and optimal management of the potentially challenging coronary access post-TAVR, requiring further research.

Coronary stent CD31-mimetic coating favours endothelialization and reduces local inflammation and neointimal development in vivo.

AIMS: The rapid endothelialization of bare metal stents (BMS) is counterbalanced by inflammation-induced neointimal growth. Drug-eluting stents (DES) prevent leukocyte activation but impair endothelialization, delaying effective device integration into arterial walls. Previously, we have shown that engaging the vascular CD31 co-receptor is crucial for endothelial and leukocyte homeostasis and arterial healing. Furthermore, we have shown that a soluble synthetic peptide (known as P8RI) acts like a CD31 agonist. The aim of this study was to evaluate the effect of CD31-mimetic metal stent coating on the in vitro adherence of endothelial cells (ECs) and blood elements and the in vivo strut coverage and neointimal growth. METHODS AND RESULTS: We produced Cobalt Chromium discs and stents coated with a CD31-mimetic peptide through two procedures, plasma amination or dip-coating, both yielding comparable results. We found that CD31-mimetic discs significantly reduced the extent of primary human coronary artery EC and blood platelet/leukocyte activation in vitro. In vivo, CD31-mimetic stent properties were compared with those of DES and BMS by coronarography and microscopy at 7 and 28 days post-implantation in pig coronary arteries (n = 9 stents/group/timepoint). Seven days post-implantation, only CD31-mimetic struts were fully endothelialized with no activated platelets/leukocytes. At day 28, neointima development over CD31-mimetic stents was significantly reduced compared to BMS, appearing as a normal arterial media with the absence of thrombosis contrary to DES. CONCLUSION: CD31-mimetic coating favours vascular homeostasis and arterial wall healing, preventing in-stent stenosis and thrombosis. Hence, such coatings seem to improve the metal stent biocompatibility.

CD31 Mimetic Coating Enhances Flow Diverting Stent Integration into the Arterial Wall Promoting Aneurysm Healing.

BACKGROUND AND PURPOSE: Beyond aneurysmal occlusion, metallic flow diverters (FDs) can induce an adverse endovascular reaction due to the foreignness of metal devices, hampering FD endothelialization across the aneurysm neck, and arterial healing of intracranial aneurysms. Here, we evaluated the potential benefits of an FD coating mimicking CD31, a coreceptor critically involved in endothelial function and endovascular homeostasis, on the endothelialization of FDs implanted in vivo. METHODS: Nitinol FD (Silk Vista Baby) and flat disks were dip-coated with a CD31-mimetic peptide via an intermediate layer of polydopamine. Disks were used to assess the reaction of endothelial cells and blood elements in vitro. An aneurysm rabbit model was used to compare in vivo effects on the arterial wall of CD31-mimetic-coated (CD31-mimetic, n=6), polydopamine-coated (polydopamine, n=6), and uncoated FDs (bare, n=5) at 4 weeks post-FD implantation. In addition, long-term safety was assessed at 12 weeks. RESULTS: In vitro, CD31-mimetic coated disks displayed reduced adhesion of blood elements while favoring endothelial cell attachment and confluence, compared to bare and polydopamine disks. Strikingly, in vivo, the neoarterial wall formed over the CD31-mimetic-FD struts at the aneurysm neck was characteristic of an arterial tunica media, with continuous differentiated endothelium covering a significantly thicker layer of collagen and smooth muscle cells as compared to the controls. The rates of angiographic complete occlusion and covered branch arterial patency were similar in all 3 groups. CONCLUSIONS: CD31-mimetic coating favors the colonization of metallic endovascular devices with endothelial cells displaying a physiological phenotype while preventing the adhesion of platelets and leukocytes. These biological properties lead to a rapid and improved endothelialization of the neoarterial wall at the aneurysm neck. CD31-mimetic coating could therefore represent a valuable strategy for FD biocompatibility improvement and aneurysm healing.

Sex differences and outcomes in surgical infective endocarditis.

BACKGROUND: Cardiac surgery for infective endocarditis (IE) is associated with significant hospital mortality, and female sex may be associated with worse outcomes. However, the impact of sex on the presenting characteristics, management, and outcomes of patients operated on for acute infective endocarditis (IE) has not been adequately studied. OBJECTIVES: The goal of our study was to analyse differences in management and outcome of IE between women and men who undergo surgery. METHODS: Clinical data of 717 patients undergoing cardiac surgery for IE between December 2005 and December 2019 were prospectively collected. Sex-related postoperative outcomes including in-hospital mortality were recorded. Univariable and multivariable analyses were performed to identify potential sex-related determinant of in-hospital mortality. RESULTS: In all, 532 male patients (74.2%) and 185 female patients (25.8%) underwent surgery for IE. At baseline, women had more frequent mitral regurgitation with 63 patients (34.1%) than men with 135 patients (25.4%) (P = 0.002). Female sex was associated with higher in-hospital mortality (23.2% versus 17.3%, P = 0.049). However, multivariable analysis revealed age (P < 0.01), antibiotics < 7 days before surgery (P = 0.01) and staphylococcal IE (P < 0.01) but not female sex (P = 0.99) as independent determinants of hospital mortality. CONCLUSIONS: In this study of patients operated-on for IE, female sex was associated with more severe manifestations of IE and significantly higher in-hospital mortality. However, after multivariable analysis, initial presentation, but not sex, seemed to determine clinical outcomes.

Optimal or standard control of systolic and diastolic blood pressure across risk factor categories in patients with chronic coronary syndromes.

AIMS: Guidelines have lowered blood pressure (BP) targets to <130/80 mmHg. We examined the benefit of intensive control for each BP component, vs. the burden of other modifiable risk factors, in patients with chronic coronary syndromes (CCS). METHODS AND RESULTS: The CLARIFY registry (ISRCTN43070564) enrolled 32 703 patients with CCS, from 2009 to 2010, with a 5-year follow-up. Patients with either BP component below European guideline safety boundaries (120/70 mmHg) were excluded, leaving 19 167 patients (mean age: 63.8 ± 10.1 years, 78% men) in the present analysis. A multivariable-adjusted Cox proportional hazards model showed a gradual increase in cardiovascular risk (cardiovascular death, myocardial infarction, or stroke) when the number of uncontrolled risk factors (active smoking, no physical activity, low-density lipoprotein cholesterol ≥100 mg/dL, and diabetes with glycated haemoglobin ≥7%) increased [adjusted hazard ratio (HR): 1.34; 95% confidence interval (CI): 1.17-1.52, 1.65 (1.40-1.94), and 2.47 (1.90-3.21) for 1, 2, and 3 or 4 uncontrolled risk factors, respectively, vs. 0], without significant interaction with BP. Although uncontrolled systolic (≥140 mmHg) and diastolic (≥90 mmHg) BP were both associated with higher risk than standard BP, standard BP was associated with higher risk than optimal control for only the diastolic component (adjusted HR: 1.08; 95% CI: 0.94-1.25 for systolic BP 130-139 vs. 120-129 mmHg and 1.43; 95% CI: 1.27-1.62 for diastolic BP 80-89 vs. 70-79 mmHg). CONCLUSIONS: Our results suggest that the optimal BP target in CCS may be ≤139/79 mmHg and that optimizing the burden of other risk factors should be prioritized over the further reduction of systolic BP.

We aimed to compare the benefit associated with strict vs. standard control of blood pressure with the potential benefit of controlling other modifiable risk factors in patients with chronic coronary syndromes (CCS).Our analysis conducted in nearly 20 000 patients from the CLARIFY registry (a prospective international cohort of patients with CCS) showed that the benefit associated with strict blood pressure (BP) control (BP < 130/80 mmHg) was marginal and only driven by the diastolic component of blood pressure, whereas having one or more uncontrolled other risk factors was associated with a gradually increasing risk, for all underlying BP levels.Patients with CCS should be treated to achieve BP <140/80 mmHg. However, our results suggest that optimizing the burden of other risk factors (lipid-lowering therapy, exercise, smoking cessation, diabetes control) may need to be prioritized before considering further reduction of systolic BP.

Antithrombotic Management After Left Atrial Appendage Closure: Current Evidence and Future Perspectives.

Left atrial appendage closure is an alternative to chronic oral anticoagulation to prevent embolic events related to nonvalvular atrial fibrillation. After device implantation, antithrombotic treatment is prescribed to prevent device-related thrombosis, a dreadful complication associated with an increased risk of ischemic events. However, the optimal antithrombotic treatment after left atrial appendage closure, effective on both device-related thrombus prevention and bleeding risk mitigation, remains to be determined. In more than 10 years experience with left atrial appendage closure, a wide range of antithrombotic treatments have been used, mostly in observational studies. In this review, we analyzed the body of evidence for each antithrombotic regimen after left atrial appendage closure to provide tools to guide the physician choice and describe future perspectives in the field.

Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valve or Dedicated Devices: Current Evidence and Future Prospects.

Transcatheter mitral valve replacement (TMVR) is a novel and evolving field dedicated to addressing the therapeutic challenges posed by patients at high surgical risk with mitral valve disease. TMVR can be categorized into two distinct fields based on the type of device and its specific indications: TMVR with transcatheter aortic valves (TAV) and TMVR with dedicated devices. Similar to aortic stenosis, TMVR with TAV requires a rigid support structure to secure the valve in place. As a result, it is indicated for patients with failing bioprothesis or surgical rings or mitral valve disease associated with severe mitral annular calcification (MAC), which furnishes the necessary foundation for valve anchoring. While TMVR with TAV has shown promising outcomes in valve-in-valve procedures, its effectiveness remains more contentious in valve-in-ring or valve-in-MAC procedures. Conversely, TMVR with dedicated devices seeks to address native mitral regurgitation, whether accompanied by MAC or not, providing an alternative to Transcatheter Edge-to-Edge Repair (TEER) when TEER is not feasible or expected to yield unsatisfactory results. This emerging field is gradually surmounting technical challenges, including anchoring a valve in a non-calcified annulus and transitioning from the transapical route to the transeptal approach. Numerous devices are presently undergoing clinical trials. This review aims to furnish an overview of the supporting evidence for TMVR using TAV in each specific indication (valve-in-valve, valve-in-ring, valve-in-MAC). Subsequently, we will discuss the anticipated benefits of TMVR with dedicated devices over TEER, summarize the characteristics and clinical results of TMVR systems currently under investigation, and outline future prospects in this field.

Antithrombotic therapy and cardiovascular outcomes after transcatheter aortic valve implantation in patients without indications for chronic oral anticoagulation: a systematic review and network meta-analysis of randomized controlled trials.

AIMS: As the antithrombotic regimen that may best prevent ischaemic complications along with the lowest bleeding risk offset following transcatheter aortic valve implantation (TAVI) remains unclear, we aimed to compare the safety and efficacy of antithrombotic regimens in patients without having an indication for chronic oral anticoagulation. METHODS AND RESULTS: We conducted a PROSPERO-registered (CRD42021247924) systematic review and network meta-analysis of randomized controlled trials evaluating post-TAVI antithrombotic regimens up to April 2022. We estimated the relative risk (RR) and 95% confidence intervals (95% CIs) using a random-effects model in a frequentist pairwise and network metanalytic approach. We included seven studies comprising 4006 patients with a mean weighted follow-up of 12.9 months. Risk of all-cause death was significantly reduced with dual antiplatelet therapy (DAPT) compared with low-dose rivaroxaban + 3-month single antiplatelet therapy (SAPT) (RR 0.60, 95% CI 0.41-0.88), while no significant reduction was observed with SAPT vs. DAPT (RR 1.02, 95% CI 0.67-1.58) and SAPT and DAPT compared with apixaban or edoxaban (RR 0.60, 95% CI 0.32-1.14 and RR 0.59, 95% CI 0.34-1.02, respectively). SAPT was associated with a significant reduction of life-threatening, disabling, or major bleeding compared with DAPT (RR 0.45, 95% CI 0.29-0.70), apixaban or edoxaban alone (RR 0.45, 95% CI 0.25-0.79), and low-dose rivaroxaban + 3-month SAPT (RR 0.30, 95% CI 0.16-0.57). There were no differences between the various regimens with respect to myocardial infarction, stroke, or systemic embolism. CONCLUSION: Following TAVI in patients without an indication for chronic oral anticoagulant, SAPT more than halved the risk of bleeding compared with DAPT and direct oral anticoagulant-based regimens without significant ischaemic offset.

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.

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.

Percutaneous Transcatheter Edge-to-Edge Mitral Valve Repair With MitraClip System in the Era of G4.

The use of transcatheter edge-to-edge mitral valve repair (TEER) in symptomatic patients with severe mitral regurgitation (MR) has dramatically increased over the last few years. Current guidelines consider TEER as a reasonable option in symptomatic patients with primary or chronic secondary severe MR with high or prohibitive surgical risk and favorable anatomy. However, several anatomical and morphological mitral features have restricted the use of this mini-invasive technique in its early experience. The latest fourth generation (G4) of the MitraClip system has been recently introduced and includes the possibility of independent leaflet grasping and 4 different sizes. This technical update offers the possibility of selecting and combining multiple devices for complex mitral valve anatomies and challenging procedures, which helps expand the applications of TEER. The present review describes the potential advantages and the help of the MitraClip G4 devices to overcome various anatomic and morphologic issues in challenging cases with complex primary and secondary MR procedures.

Impact of the antiplatelet strategy following patent foramen ovale percutaneous closure.

AIMS: Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge. METHODS AND RESULTS: The ambispective AIR-FORCE cohort included consecutive patients from seven centres in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centres were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. A total of 1532 patients (42.2% female, median age: 49 [40-57] years) were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases. After a median follow-up of 2.4 [1.1-4.4] years, a total of 58 events were observed. In the weighted analysis, the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83). CONCLUSION: The antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.

Incidence, predictors, and prognostic significance of impaired functional status early after transcatheter aortic valve replacement.

INTRODUCTION AND OBJECTIVES: There are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR. METHODS: This multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis. RESULTS: The mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up. CONCLUSIONS: Up to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed.

Optimal Degree of Balloon-Expandable Transcatheter Valve Oversizing in Patients With Borderline Aortic Annulus Measurements: Insights From a Multicenter Real-World Experience.

BACKGROUND: The potential benefit of using larger or smaller transcatheter heart valves (THV) in patients with borderline aortic annulus measurement (BAM) remains uncertain. The objective of this study was to evaluate the clinical outcomes associated with the selection of larger or smaller THV in the context of BAM. METHODS: This was a multicenter observational study including patients who underwent transcatheter aortic valve replacement with the SAPIEN 3 or SAPIEN 3 Ultra-valve systems (Edwards Lifesciences, Irvine, CA) from April 2014 to June 2021. BAM was defined according to the manufacturer sizing chart and included the following annulus areas: 314 to 346, 400 to 430, 500 to 546 mm2. A 1:1 propensity score matching was used to compare outcomes of patients with larger or smaller THV. RESULTS: From a total of 2467 patients, BAM was identified in 852 patients (34.5%). A larger and smaller THV was selected in 338 (39.7%) and 514 patients (60.3%) patients, respectively. The choice of a larger THV was associated (before and after propensity matching) with a higher risk of new-onset left bundle branch block (HR, 2.25 [95% CI, 1.39-3.65; P=0.001) and permanent pacemaker implantation (HR, 1.86 [95% CI, 1.11-3.09]; P=0.016) without any impact on gradients or the risk of moderate or severe paravalvular regurgitation at discharge (HR, 0.78 [95% CI, 0.41-1.45]; P=0.427). The risk of periprocedural complications such as aortic rupture and tamponade was low (<1%) and similar between groups. CONCLUSIONS: In patient with BAM, selecting a larger SAPIEN 3/Ultra THV increased the risk of conduction disturbances without any benefit on valve hemodynamics and clinical outcomes.

Cardiac Death After Transcatheter Aortic Valve Replacement With Contemporary Devices.

BACKGROUND: The burden of cardiac death after transcatheter aortic valve replacement (TAVR), particularly from advanced heart failure (HF) and sudden cardiac death (SCD), remains largely unknown. OBJECTIVES: This study sought to evaluate the incidence and predictors of SCD and HF-related death in TAVR recipients treated with newer-generation devices. METHODS: This study included a total of 5,421 consecutive patients who underwent TAVR with newer-generation devices using balloon (75.7%) or self-expandable (24.3%) valves. RESULTS: After a median follow-up of 2 (IQR: 1-3) years, 976 (18.0%) patients had died, 50.8% from cardiovascular causes. Advanced HF and SCD accounted for 11.6% and 7.5% of deaths, respectively. Independent predictors of HF-related death were atrial fibrillation (HR: 2.17; 95% CI: 1.47-3.22; P < 0.001), prior pacemaker (HR: 1.79; 95% CI: 1.10-2.92; P = 0.01), reduced left ventricular ejection fraction (HR: 1.08 per 5% decrease; 95% CI: 1.01-1.14; P = 0.02), transthoracic approach (HR: 2.50; 95% CI: 1.37-4.55; P = 0.003), and new-onset persistent left bundle branch block (HR: 1.85; 95% CI: 1.14-3.02; P = 0.01). Two baseline characteristics (diabetes, HR: 1.81; 95% CI: 1.13-2.89; P = 0.01; and chronic kidney disease, HR: 1.72; 95% CI: 1.02-2.90; P = 0.04) and 3 procedural findings (valve in valve, HR: 2.17; 95% CI: 1.01-4.64; P = 0.04; transarterial nontransfemoral approach, HR: 2.23; 95% CI: 1.23-4.48; P = 0.01; and periprocedural ventricular arrhythmia, HR: 7.19; 95% CI: 2.61-19.76; P < 0.001) were associated with an increased risk of SCD after TAVR. CONCLUSIONS: Advanced HF and SCD accounted for a fifth of deaths after TAVR in contemporary practice. Potentially treatable factors leading to increased risk of HF deaths and SCD were identified, such as arrhythmia/dyssynchrony factors for HF and valve-in-valve TAVR or periprocedural ventricular arrhythmias for SCD.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Evolving Indications of Transcatheter Aortic Valve Replacement-Where Are We Now, and Where Are We Going.

Indications for transcatheter aortic valve replacement (TAVR) have steadily increased over the last decade since the first trials including inoperable or very high risk patients. Thus, TAVR is now the most common treatment of aortic valve stenosis in elderly patients (vs. surgical aortic valve replacement -SAVR-). In this review, we summarize the current indications of TAVR and explore future directions in which TAVR indications can expand.

Carotid ultrasound following transcarotid transcatheter aortic valve replacement.

BACKGROUND: Transcarotid (TC) is a common alternative access for transcatheter aortic valve replacement (TAVR) when the transfemoral route is not suitable. However, scarce data exist on systematic ultrasound (US) follow-up of these patients. This study aims to evaluate the safety of TC-TAVR using pre-and post-procedure carotid artery US assessment. METHODS: We performed an observational prospective study including 50 consecutive patients who underwent TC-TAVR that had a follow-up at our institution between September 2016 and July 2020. RESULTS: All patients had a carotid US examination at a median time of 13 months (IQR: 5-17) following the procedure. Thirty-six (71%) patients also had a US examination prior to the procedure. Mean pre-procedural access route common carotid artery (AR-CCA) peak systolic velocity (PSV) was 62.9 cm/s (SD:16.8) vs. 69.0 cm/s (SD: 53.4) in the contralateral CCA (CL-CCA), p = 0.562). There was a significant increase in post-procedural PSV values in the AR-CCA (30.3 cm/s (SD: 36.3), p < 0.001) but not in the CL-CCA (5.8 cm/s (SD: 51.7), p = 0.503). Two new carotid stenoses (4%) were diagnosed after the procedure. No baseline or procedural variables were associated with a higher increase in carotid flow velocities at follow-up. There were no cerebrovascular events related to these findings after a median follow-up of 29 months (IQR:13-33). CONCLUSIONS: TC-TAVR was associated with a mild but significant increase in carotid flow velocities, with new significant (>50%) carotid stenosis diagnosed in 4% of patients. These findings were not associated with clinical events after a median follow-up of 2 years. Further studies are warranted.

Transcatheter Patent Foramen Ovale Closure in Stroke Patients with Thrombophilia: Current Status and Future Perspectives.

Transcatheter patent foramen ovale (PFO) closure is a safe and effective treatment for secondary prevention after a PFO-associated stroke as demonstrated in multiple large randomized clinical trials. However, these trials excluded a significant proportion of patients who could have benefited from percutaneous PFO closure due to coexisting potential confounders such as additional thromboembolic risk factors, namely thrombophilia. Since scarce and conflicting data existed on such patients, current clinical management guidelines on patients with PFO mainly recommended against PFO closure in patients with thrombophilia and failed to provide any recommendation on the type and duration of antithrombotic treatment after transcatheter PFO closure. In the past 2 years, there has been new evidence supporting transcatheter PFO closure as a clinically meaningful alternative (vs. medical treatment) in this high-risk group of patients, along with additional data supporting the important role of systematic screening for thrombophilia in PFO-associated cerebrovascular events. This review article provides an updated overview of the incidence, clinical characteristics and outcomes of PFO closure in patients with thrombophilia, also commenting on the most appropriate medical treatment after PFO closure and future perspectives in the field.