Search

Aims Cardiac amyloidosis (CA) has a poor prognosis which is aggravated by diagnostic delay. Amyloidosis extracardiac and cardiac events (AECE and ACE) may help improve CA diagnosis and typing. The aim of this study was to compare AECE and ACE between different CA types and assess their relationship with survival. Methods and results This retrospective cohort study conducted in France from June 2008 to May 2019, at the Henry Mondor Hospital. This cohort included 983 patients with CA. Mean age at inclusion was 73.1 ± 11.4 years, 726 (75.1%) were male and the mean body mass index was 24.5 ± 4.1 kg/m2. Among them, 321 had immunoglobulin light chain (AL) amyloidosis, 434 had wild‐type transthyretin (ATTRwt), and 212 had hereditary transthyretin (ATTRv). The first AECE and/or ACE occurred at a mean age of 63 ± 11 years for AL and ATTRv, and 70 ± 12 years for ATTRwt (P

Objectives Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). Background The choice of optimal drug for anticoagulation after TAVR remains debated. Methods Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). Results A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P Conclusions In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.

Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate over time and therefore may necessitate a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve study, which evaluated transcatheter aortic valve implantation using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective Valve-in-Valve study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation, or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve transcatheter aortic valve implantation cases. Two-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality rate was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs 7.6%, p = 0.025). Discharge mean gradients ≥20 mm Hg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3 to 22.1]. In patients with failing surgical aortic bioprostheses, valve-in-valve treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of20 mmHg can be achieved.

Background The approach for veno-arterial extracorporeal membrane oxygenation implantation (VA-ECMO) in patients with cardiogenic shock can be either surgical or percutaneous. Complete angio-guided percutaneous implantation and explantation could decrease vascular complications. We sought to describe the initial results of complete percutaneous angio-guided ECMO implantation and explantation using preclosing. Methods All consecutive patients who underwent peripheral femoro-femoral VA-ECMO percutaneous implantation for refractory cardiogenic shock or cardiac arrest were enrolled in a prospective registry (03/2018–12/2020). Percutaneous preclosing using two closing devices (Perclose ProGlide, Abbott) inserted before cannulation was used in both femoral artery and vein. Explantation was performed using a crossover technique under angiographic guidance. The occurrence of vascular complication was recorded. Results Among the 56 patients who underwent percutaneous VA-ECMO implantation for cardiogenic shock or refractory cardiac arrest, 41 underwent preclosing. Femoral vessel cannulation was successful in all patients and total cannulation time was 20 (10–40) min. Weaning from ECMO was possible in 22/41 patients (54%) and 12 (29%) patients were alive at day 30. Significant vascular complications occurred in 2/41 patients. Percutaneous decannulation was performed in 20 patients with 19/20 technical success rate. All femoral arteries and veins were properly closed using the pre-closing devices without bleeding on the angiographic control except for one patient in whom surgical closure of the artery was required. No patient required transfusion for access related significant bleeding and no other vascular complication occurred. Furthermore, no groin infection was observed after full percutaneous implantation and removal of ECMO. Conclusion Emergent complete percutaneous angio-guided VA-ECMO implantation and explantation using pre-closing technique can be an attractive strategy in patients referred for refractory cardiogenic shock.

Background We aimed to report clinical characteristics and outcomes of patients with and without SARS-CoV-2 infection referred for acute coronary syndrome (ACS) during the peak of the pandemic in France. Methods We included all consecutive patients referred for ST-elevation myocardial infarction (STEMI) or NSTEMI during the first 3 weeks of April 2020 in 5 university hospitals (Paris, south and north of France), all performing primary percutaneous coronary intervention (PCI). Results The study included 237 patients (67±14, 69% of male), 116 (49%) with STEMI and 121 (51%) with NSTEMI. The prevalence of SARS-CoV-2 associated ACS was 11% (n=26) and 11 patients had severe hypoxemia on presentation (mechanical ventilation or nasal oxygen >6L/min). Patients were comparable regarding medical history and risk factors, except a higher prevalence of diabetes mellitus in SARS-CoV-2 patients (53.8% vs 25.6%, p=0.003). In SARS-CoV-2 patients, cardiac arrest on admission was more frequent (26.9% vs. 6.6%, p, In this registry we included patients presenting with ACS during the first pic of the SARS-CoV-2 epidemic in France. ACS in SARS-CoV-2 patients presented with high percentage of cardiac arrest on admission, high incidence of no-reflow and high in-hospital mortality. Further studies are needed in order to elucidate the mechanisms and the optimal management of coronary thrombosis in SARS-CoV- 2 patients.

Short RP interval atrioventricular re-entrant tachycardias do not typically present as an incessant form. We present 2 cases of incessant atrioventricular re-entrant tachycardias leading to tachycardia-induced cardiomyopathy with severe heart failure presentation in middle-aged adults. Both underwent accessory pathway ablation and recovered normal left ventricle function before hospital discharge. (Level of Difficulty: Intermediate.), Graphical abstract

Patients with high-gradient (HG) severe aortic stenosis (AS) and left ventricular (LV) dysfunction are at high risk of death. The optimal timing for aortic valve replacement (AVR) is not defined by guidelines. The objective was to define the optimal timing to perform isolated AVR in patients with HG-AS and severe LV dysfunction.We retrospectively included 233 consecutive patients admitted for severe HG-AS (aortic valve area1cmPatients with HG-AS and severe LV dysfunction had a higher risk profile than those with LVEF35%. AVR was performed in 93% (218/233) of patients, 41% by surgery (SAVR) and 53% by transcatheter (TAVR). TAVR was the preferred method to treat HG-AS patients with LVEF ≤35%. All-cause mortality while waiting for AVR was higher in patients with severe LV dysfunction (22% vs. 2.0%,AVR should be performed promptly after Heart Team decision in patients with HG severe AS and LVEF ≤35% because of a very high and premature risk of death while waiting for intervention.

AIMS Hereditary (ATTRv) and wild-type (ATTRwt) transthyretin amyloidosis are severe and fatal systemic diseases, characterised by amyloid fibrillar accumulation principally in the heart or peripheral nerves (or both). Since 2012, tafamidis has been used in France to treat patients with ATTRv with neuropathy (alone or combined with cardiomyopathy). Recently, the Phase III ATTR-ACT trial showed that tafamidis decreased the relative risk of mortality in ATTR amyloidosis with cardiomyopathy. The aims of this study were to assess the clinical characteristics of ATTR amyloidosis in a real-life population in comparison to the population included in the ATTR-ACT trial and to assess the impact of tafamidis treatment on major cardiovascular outcome (MCO)-free survival time without cardiac decompensation, heart transplant, or death. METHODS AND RESULTS From June 2008 to November 2018, 648 patients with ATTR amyloidosis (423 ATTRwt and 225 ATTRv) consecutively referred to the French Referral Center for cardiac amyloidosis were included. A total of 467 (72%) patients matched the inclusion criteria of the ATTR-ACT trial. For the 631 patients with cardiomyopathy, tafamidis treatment was associated with a longer median MCO-free survival time (n = 98): 1565 (1010-2400) days vs. 771 (686-895) days without treatment (log-rank P

In patients admitted for acute myocardial infarction, the communication and transition from specialists to primary care physicians is often delayed, and the information imparted to subsequent healthcare providers (HCPs) may be sub-optimal. A French group of cardiologists, lipidologists and diabetologists decided to establish a consensus to optimize the discharge letter after hospitalization for acute myocardial infarction. The aim is to improve both the timeframe and the quality of the content transmitted to subsequent HCPs, including information regarding baseline assessment, procedures during hospitalization, residual risk, discharge treatments, therapeutic targets and follow-up recommendations in compliance with European Society of Cardiology guidelines. A consensus was obtained regarding a template discharge letter, to be released within two days after patient’s discharge, and containing the description of the patient’s history, risk factors, acute management, risk assessment, discharge treatments and follow-up pathway. Specifically for post acute MI patients, tailored details are necessary regarding the antithrombotic regimen, lipid-lowering and anti-diabetic treatments, including therapeutic targets. Lastly, the follow-up pathway needs to be precisely mentioned in the discharge letter. Additional information such as technical descriptions, imaging, and quality indicators may be provided separately. A template for a standardized discharge letter based on 8 major headings could be useful for implementation in routine practice and help to improve the quality and timing of information transmission between HCPs after acute MI.

A patient with severe, symptomatic functional mitral regurgitation was initially considered not suitable for MitraClip (Abbott Vascular, Abbott Park, Illinois) implantation because of non-coapting mitral leaflets. Repeated levosimendan infusions in combination with intensive diuresis induced sufficient valve coaptation, thus allowing MitraClip implantation to be performed. (Level of Difficulty: Intermediate.), Graphical abstract, A patient with severe, symptomatic functional mitral regurgitation was initially considered not suitable for MitraClip (Abbott Vascular, Abbott Park…

@DrHulot_PARCC Anti-platelet therapy adjustment guided by CYP2C19 genotyping can be done in

Backgrounds: Data on optimal antiplatelet therapy in patients undergoing stenting of the proximal left anterior descending artery (LAD) are limited. Methods: This is a post-hoc analysis of the GLOBAL LEADERS trial, a prospective, multi-center, randomized controlled trial, comparing the experimental strategy (1-month dual anti-platelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) with the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in relation to stenting of the proximal LAD. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. Results: Among 15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not. In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62–1.20; Pinteraction = 0.951). However, the risk of any MI (2.63% vs. 3.88%; HR:0.68; 95% CI:0.47–0.97; Pinteraction = 0.015) and any revascularization (7.84% vs. 9.94%; HR:0.78; 95% CI:0.63–0.97; Pinteraction = 0.058) was significantly lower in the experimental strategy group, while demonstrating a similar risk of BARC type 3 or 5 bleeding between the two antiplatelet strategies (1.93% vs. 1.99%; HR:0.98; 95% CI:0.62–1.54; Pinteraction = 0.981). Conclusions: The present study showed patients having stenting to the proximal LAD could potentially benefit from the experimental strategy with lower ischaemic events without a trade-off in major bleeding at two years.

Tricuspid regurgitation is serious disease for which surgical correction is underperformed because of a prohibitive risk. It is responsible for a 50% mortality at 3 years which is decreased by surgical treatment. However, only a negligible proportion of patients undergoes surgery. In this context, there is currently an unmet need for percutaneous treatment technique. Several technologies are undergoing preclinical or early clinical development. These techniques aim to mimic the different surgical strategies used for the treatment of tricuspid regurgitation. Thus, some target the leaflets, the tricuspid annulus or offer a complete tricuspid valve replacement. Before planning a transcatheter tricuspid intervention, a comprehensive evaluation is mandatory, addressing the patient clinical status and comorbidities, the tricuspid regurgitation ad its consequences on right heart and, the anatomy of the tricuspid annulus and the right heart to determine if the patient is eligible for the chosen technique. This article will review the indications, contraindications and exams to perform before transcatheter tricuspid intervention and will then detail the different strategies available or undergoing development.

Highlights •CA may be present in ≤15% of patients with AS. •Clinical and imaging “red flags” for CA should be systematically searched in patients with AS. •Transcatheter rather than surgical AVR may be preferred in patients with CA. •Recently developed pharmacological treatment for transthyretin CA should be instituted as soon as diagnosis is confirmed.

Background: We assesse the evolution and prognostic value of N-terminal pro-brain natriuretic peptide (NT-proBNP) and high-sensitivity troponin T (cTnT-HS) in transthyretin amyloid cardiomyopathy (ATTR-CA) before and after tafamidis treatment. Methods and Results: 454 ATTR-CA patients without tafamidis (Cohort A) and 248 ATTR-CA with tafamidis (Cohort B) were enrolled. Event-free survival (EFS) events were death, heart transplant, or acute heart failure. In Cohort A, 27% of patients maintained NT-proBNP &lt, 3000 ng/L and 14% cTnT-HS &lt, 50 ng/L at 12 months relative to baseline levels. In Cohort B, the proportions were 49% and 29%, respectively. In Cohort A, among the 333 patients without an increased NT-proBNP &gt, 50% relative to baseline EFS was extended compared to the 121 patients with an increased NT-proBNP &gt, 50% (HR: 0.75 [0.57, 0.98], p = 0.032). In Cohort A, baseline NT-proBNP &gt, 3000 ng/L and cTnT-HS &gt, 50 ng/L and a relative increase of NT-proBNP &gt, 50% during follow-up were independent prognostic factors of EFS. The slopes of logs NT-proBNP and cTnT-HS increased with time before and stabilized after tafamidis. Conclusion: ATTR-CA patients with increasing NT-proBNP had an increased risk of EFS. Tafamidis stabilize NT-proBNP and cTnT-HS increasing, even if initial NT-proBNP levels were &gt, 3000 ng/L. Thus suggesting that all patients, irrespective of baseline NT-proBNP levels, may benefit from tafamidis.

Aims: Multimodal imaging has allowed cardiac amyloidosis (CA) to be increasingly recognised as a treatable cause of heart failure with preserved ejection fraction, but its prognosis remains poor due to late diagnosis. To assess the left ventricular diastolic function (LVDF) patterns in a large contemporary CA cohort according to the current recommendations and to identify their determinants. Methods and Results: We conducted a monocentric, observational study on a cohort of CA patients from a tertiary CA referral centre. Diastolic function was analysed using standard echocardiography and clinical, laboratory and survival parameters were collected. Four hundred and sixty-four patients with one of the three main type of CA were included: 41% had grade III diastolic dysfunction (restrictive mitral pattern), 25% had grade II diastolic dysfunction, and 25% had grade I diastolic dysfunction, 9% were unclassified. No difference was found between the main CA types. After multivariate analyses, grades II and III were independently associated with dyspnoea, elevated NT-proBNP, cardiac infiltration and systolic dysfunction (global longitudinal strain). Grade I patients had a better prognosis. Conclusions: All LVDF patterns can be observed in CA. One quarter of CA patients have grade I LVDF, reflecting the emergence of earlier stage-related phenotypes with a better prognosis.

Background Cardiac light chain amyloidosis (AL-CA) patients often die within three months of starting chemotherapy. Chemotherapy for non-immunoglobulin M gammopathy with AL-CA frequently includes bortezomib (Bor), cyclophosphamide (Cy), and dexamethasone (D). We previously reported that NT-ProBNP levels can double within 24h of dexamethasone administration, suggesting a deleterious impact on cardiac function. In this study, we evaluate the role of dexamethasone in early cardiovascular mortality during treatment. Methods and findings We retrospectively assessed 100 de novo cardiac AL patients (62% male, mean age 68 years) treated at our institute between 2009 and 2018 following three chemotherapy regimens: CyBorDComb (all initiated on day 1; 34 patients), DCyBorSeq (D, day 1; Cy, day 8; Bor, day 15; 17 patients), and CyBorDSeq (Cy, day 1; Bor, day 8; D, day 15; 49 patients). The primary endpoint was cardiovascular mortality and cardiac transplantation at days 22 and 455. At day 22, mortality was 20.6% with CyBorDComb, 23.5% with DCyBorSeq, and 0% with CyBorDSeq (p = 0.003). At day 455, mortality was not significantly different between regimens (p = 0.195). Acute toxicity of dexamethasone was evaluated on myocardial function using a rat model of isolated perfused heart. Administration of dexamethasone induced a decrease in left ventricular myocardium contractility and relaxation (p Conclusion Delaying dexamethasone during the first chemotherapy cycle reduces the number of early deaths without extending survival. It is clear that dexamethasone is beneficial in the long-term treatment of patients with AL-CA. However, the initial introduction of dexamethasone during treatment is critical, but may be associated with early cardiac deaths in severe CA. Thus, it is important to consider the dosage and timing of dexamethasone introduction on a patient-severity basis. The impact of dexamethasone in the treatment of AL-CA needs further investigation.

Mean Gradient (MG) elevation can be detected immediately after transcatheter aortic valve implantation (TAVI) or secondarily during follow-up. Comparisons and interactions between these two parameters and their impact on outcomes have not previously been investigated. This study aimed to identify incidence, influence on prognosis, and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (6 to 12 months after TAVI, DMGI) in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The registry includes all consecutive symptomatic patients with severe aortic stenosis who have undergone TAVI. Three groups were analyzed: (1) PPMG &lt, 20 mmHg without DMGI &gt, 10 mmHg (control), (2) PPMG &lt, 20 mmHg with DMGI &gt, 10 mmHg (Group 1), and (3) PPMG ≥ 20 mmHg (Group 2). From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. Controls comprised 2078 patients. In Group 1(n = 131 patients), DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-years mortality than in controls (32.6% vs. 40.1%, p = 0.27). In Group 2 (n = 144 patients), PPMG was at least 20 mmHg in 6.1% and was associated with higher 4-year mortality (48.7% versus 40.1%, p = 0.005). A total of two-thirds of the patients with PPMG ≥ 20 mmHg had MG &lt, 20 mmHg at 1 year, with mortality similar to the controls (39.2% vs. 40.1%, p = 0.73). Patients with PPMG &gt, 20 mmHg 1 year post-TAVI had higher 4-years mortality than the general population of the registry, unlike patients with MG normalization.

International audience; Atrial fibrillation is the most common cause of arrhythmia which is responsible for over 15% of ischemic strokes, most of these being secondary to migration of a left atrial appendage (LAA) thrombus. In patient with contraindication to anticoagulant therapy, percutaneous closure system placement may be indicated. Cardiac computed tomography (CT) angiography plays a central role in the initial assessment as well as in the follow-up. The purpose of the pre-implantation cardiac CT angiography is to evaluate the anatomy of the LAA in order to select the most suitable prosthesis and check for any contraindication to device implantation. Image analysis is divided into four steps that include analysis of the approach; search for a thrombus in the LAA; investigation of the anatomy of the LAA (morphology of the LAA, dimensions of the LAA and choice of device) and cardiac and thoracic assessments. Follow-up involves CT examination to check for correct placement of the device and to detect any complications. On the basis of the results of currently available published research, a panel of experts has issued recommendations regarding cardiac CT angiography prior to percutaneous LAA closure device placement, which were further endorsed by the Société française d'imagerie cardiaque et vasculaire diagnostique et interventionnelle (SFICV).

International audience; Objectives The French left atrial appendage (LAA) closure registry (FLAAC) aimed to assess the safety and efficacy of LAA closure in daily practice. Background LAA closure has emerged as an alternative for preventing thromboembolic events (TE) in patients with non-valvular atrial fibrillation (NVAF). Clinical data in this field remains limited and few investigator-initiated, real-world registries have been reported. Methods This nationwide, prospective study was performed in 36 French centers. The primary endpoint was the TE rate after successful LAA closure. Results The FLAAC registry included 816 patients with a mean age of 75.5 +/- 0.3 years, mean follow-up of 16.0 +/- 0.3 months, high TE (CHA(2)DS(2)-VASc score: 4.6 +/- 0.1) and bleeding risks (HAS-BLED score: 3.2 +/- 0.05) and common contraindications to long-term anticoagulation (95.7%). Procedure or device-related serious adverse events occurred in 49 (6.0%) patients. The annual rate of ischemic stroke/systemic embolism was 3.3% (2.4-4.6). This suggests a relative 57% reduction compared to the risk of stroke in historical NVAF populations without antithrombotic therapy. By multivariate analysis, history of TE was the only factor associated with stroke/systemic embolism during follow-up (HR, 3.3 [1.58-6.89], p = .001). The annual mortality rate was 10.2% (8.4-12.3). Most of the deaths were due to comorbidities or underlying cardiovascular diseases and unrelated to the device or to TE. Conclusions Our study suggests that LAA closure can be an option in patients with NVAF. Long-term follow-up mortality was high, mostly due to comorbidities and underlying cardiovascular diseases, highlighting the importance of multidisciplinary management after LAA closure. Registration NCT02252861.

Background Percutaneous left atrial appendage (LAA) closure is an alternative to oral anticoagulation (OAC) for atrial fibrillation (AF) patients with high thromboembolism risk, particularly with contraindications to OAC. The LAA itself could possess proarrhythmogenic properties. As patients undergoing LAA closure could be candidates for cardioversion or ablation, we aimed to evaluate AF disease progression following LAA closure and the outcome of patients undergoing a rhythm control strategy after the procedure. Methods The prospective multicenter French Nationwide Observational LAA Closure Registry (FLAAC) comprises 33 French interventional cardiology departments. Patients were included if they fulfilled the following criteria: history of non-valvular AF, successful LAA closure and long-term ECG follow-up. Results A total of 331 patients with successful LAA closure were enrolled in the study. Patients mean age was 75.4 ± 0.5 years. The study population was characterized by a high thromboembolic risk (CHA2DS2-VASc score: 4.5 ± 0.1) and frequent comorbidities. The median follow-up was 11.9 months. One hundred and nineteen (36.0%) patients were in sinus rhythm (SR) at baseline. Among SR patients, documented AF was observed in 16 (13.4%) patients whereas 15 (7.1%) patients in AF at baseline restored SR, at the end of follow up. Finally, only 13 patients (4%) underwent procedures to restore SR without complications during the follow-up. Conclusions The vast majority of patients undergoing LAA closure have the same AF status at baseline and one year after the index procedure. During the follow-up, a very small proportion (4%) of our population underwent procedures to restore SR without complications whatever the post-procedural antithrombotic strategy was.

Objectives The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation. Background Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery. Methods VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve. Results Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later. Conclusions Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298)

Aims Same-day discharge (SDD) after percutaneous coronary intervention (PCI) was safe and cost-effective in randomized and observational studies but faces limited acceptance due to concerns about early adverse events. Our aim was to evaluate early outcomes after SDD PCI in a high-volume urban PCI center over 10 years. Methods and results From 2007 to 2016, 1,635 unselected patients had PCI at our ambulatory cardiac care unit, mainly for stable ischemic heart disease (SIHD). Among them, 1,073 (65.6%), most of whom underwent ad hoc PCI, were discharged on the same day and 562 (34.4%) were admitted, for adverse events during PCI (n = 60) or within the next 4-6 hr (n = 52) or chiefly due to physician preference (n = 450). In the SDD group, radial access was used in 98.5% of patients; 36% and 15% of patients had two- and three-vessel disease, respectively; and two-vessel PCI was performed in 11% of patients. No MACCEs (death, myocardial infarction, stroke, urgent repeat PCI/CABG, and major vascular complications) occurred within 24 hr post-discharge. Two patients were readmitted on the next day for chest pain but did not require repeat PCI. Conclusion SDD after successful PCI without complications within the next 4-6 hr is safe and feasible in most patients with SIHD. Among 1,035 SDD patients treated over 10 years, only two required readmission, and none experienced major cardiac adverse events such as death or stent thrombosis. SDD is safe for the patient and cost-effective for the healthcare system and should be implemented more widely.

Background: \ud Spontaneous coronary artery dissection (SCAD) is an increasingly recognized cause of acute coronary syndromes (ACS) afflicting predominantly younger to middle-aged women. Observational studies have reported a high prevalence of extracoronary vascular anomalies, especially fibromuscular dysplasia (FMD) and a low prevalence of coincidental cases of atherosclerosis. PHACTR1/EDN1 is a genetic risk locus for several vascular diseases, including FMD and coronary artery disease, with the putative causal noncoding variant at the rs9349379 locus acting as a potential enhancer for the endothelin-1 (EDN1) gene.\ud \ud Objectives: \ud This study sought to test the association between the rs9349379 genotype and SCAD.\ud \ud Methods: \ud Results from case control studies from France, United Kingdom, United States, and Australia were analyzed to test the association with SCAD risk, including age at first event, pregnancy-associated SCAD (P-SCAD), and recurrent SCAD.\ud \ud Results: \ud The previously reported risk allele for FMD (rs9349379-A) was associated with a higher risk of SCAD in all studies. In a meta-analysis of 1,055 SCAD patients and 7,190 controls, the odds ratio (OR) was 1.67 (95% confidence interval [CI]: 1.50 to 1.86) per copy of rs9349379-A. In a subset of 491 SCAD patients, the OR estimate was found to be higher for the association with SCAD in patients without FMD (OR: 1.89; 95% CI: 1.53 to 2.33) than in SCAD cases with FMD (OR: 1.60; 95% CI: 1.28 to 1.99). There was no effect of genotype on age at first event, P-SCAD, or recurrence.\ud \ud Conclusions: \ud The first genetic risk factor for SCAD was identified in the largest study conducted to date for this condition. This genetic link may contribute to the clinical overlap between SCAD and FMD.

International audience; Background and purpose The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial. Methods This was a planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists. Results Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up. Conclusions In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura.

Funding Acknowledgements Type of funding sources: None. Background. The approach for veno-arterial extracorporeal membrane oxygenation implantation (VA-ECMO) in patients with cardiogenic shock can be either surgical or percutaneous. Angio-guided percutaneous implantation and explantation could decrease vascular complications. Purpose We sought to describe the feasibility and safety of complete percutaneous angio-guided ECMO implantation and explantation using preclosing. Methods. All consecutive patients who underwent peripheral femoro-femoral VA-ECMO percutaneous implantation for refractory cardiogenic shock or cardiac arrest were enrolled in a prospective registry (03/2018-09/2020). Percutaneous preclosing using two closing devices (Perclose ProGlide, Abbott) inserted before cannulation was used in both femoral artery and vein. Explantation was performed using a crossover technique under fluoroscopic guidance. The occurrence of vascular complication was recorded. Results. Forty-nine patients underwent percutaneous VA-ECMO implantation for cardiogenic shock (n = 36) or refractory cardiac arrest (n = 13). Femoral vessel cannulations were successful in all patients and total cannulation time was 21± 8 min. Weaning from ECMO was possible in 23 patients (47%) and 11 (22%) patients were alive at 30-day. Significant vascular complications occurred in 3 patients (6%); all were related to distal perfusion line. One patient experienced major bleeding, and 2 experienced lower limb ischemia requiring vascular intervention (one failure of distal perfusion sheath implantation and one self-uprooting of the reperfusion cannula). Percutaneous decannulation was performed in 17 patients with 16/17 technical success rate. All femoral arteries and veins were properly closed using the pre-closing devices without bleeding on the angiographic control except for one patient in whom surgical closure of the artery was required. Among these patients, none required transfusion for access related significant bleeding and no other vascular complication occurred. Furthermore, no groin infection was observed after full percutaneous implantation and removal of ECMO. Conclusion. Emergent complete percutaneous angio-guided VA-ECMO implantation and explantation using pre-closing technique is an effective and safe strategy in patients referred for refractory cardiogenic shock or cardiac arrest.

Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The "Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.

Background:No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure.Methods:In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days.Results:Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80–1.16];P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%;P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%,P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups.Conclusions:Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation.Registration:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03399851.

Resume L’emergence du virus SARS-CoV-2 responsable de la maladie a COVID-19 a fait apparaitre une nouvelle maladie dont les contours restent encore imparfaitement connus. Alors que les premieres donnees suggeraient une infection purement respiratoire, les publications les plus recentes mettent en evidence un grand pleomorphisme de la maladie, responsable d’atteintes polyviscerales, au premier rang desquelles l’atteinte cardiaque. Cette atteinte cardiaque peut prendre la forme de myocardite aigue. L’objectif de cette revue est de discuter le rationnel physiopathologique justifiant l’existence de myocardites a SARS-CoV-2 et d’analyser les donnees de la litterature concernant le diagnostic et le traitement de cette entite particuliere.

Introduction The Genous stent is a bare metal stent (BMS) together with a technique of capturing endothelial progenitor cells. The successor of the Genous endothelial progenitor cell capturing (EPC) stent, the COMBO stent, combines this technique with the drug eluting polymer. The current studies showed promising results of the COMBO stent, however the additional value of EPC technique in overcoming neointimal hyperplasia has yet to be proven. Purpose This study sought to evaluate the efficacy and safety of the Genous EPC stent compared to BMS in a patient population with low risk for restenosis. Methods TRIAS-LR was an investigator-initiated, prospective, multicentre, single blind trial randomizing patients with low risk of restenosis 1:1 to Genous ECS or BMS. Patients were recruited between 2007 and 2014 at 31 sites across Europe. The study enrolment was terminated at 70% of the planned inclusion due to slow enrolment and change of guidelines. Patients or lesions were considered low risk if all of the following criteria were met: 1) reference vessel diameter >2.8mm, 2) lesion length Results In total, 838 patients were enrolled of whom 422 patients with 476 lesions were randomly assigned to Genous EPC stent and 416 patients with 480 lesions to BMS. The mean age was 64 years, 74% were males and in 76% patients were treated in elective setting. At 1 year TLF had occurred in 3.6% (n=15) of the Genous arm and in 6.1% (n=25) of the BMS arm (p=0.094; risk difference of −2.5%). However, this difference disappeared, at 5-years of follow-up; TLF rate was 12.6% (n=51) in the Genous arm versus 14.3% (n=58) in the BMS arm (p=0.385; risk difference of −1.7%). The secondary objective of the composite death or MI at 5 years occurred in 11.6% (n=47) in the Genous arm and 9.9% (n=40) in the BMS arm (p=0.479; risk difference of 1.7%). At 5 years definite stent thrombosis (ST) occurred in 0.5% (n=2) of the Genous arm, no definite ST had occurred in the BMS arm (p=0.162). Conclusion TRIAS-LR trial showed no differences between Genous EPC and BMS throughout 5-year follow-up in patients considered as low risk of restenosis. Kaplan-Meier plot of composite endpoints Funding Acknowledgement Type of funding source: Private company. Main funding source(s): OrbusNeich Medical BV

Background Mean gradient (MG) elevation can be detected immediately post-procedure or secondarily during follow-up. Comparison between these two parameters and impact on outcomes has not previously been investigated. Objectives The study aimed to identify incidence, influence on prognosis and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (DMGI), in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. Methods The registry includes all consecutive symptomatic patients with severe aortic stenosis. Three groups were analyzed: 1) PPMG 10 mmHg (control); 2) PPMG 10 mmHg (group 1); 3) PPMG ≥20 mmHg (group 2). Results From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. The control group comprised 2078 patients; the group 1, 131 patients; and the group 2, 144 patients. DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-year mortality than in control group (32.6% vs. 40.1%, p=0.27, respectively). PPMG was at least 20 mmHg in 6.1%, and was associated with higher 4-year mortality than in control group (48.7% versus 40.1%, p=0.005, respectively) (Figure 1). Two-thirds of patients with initial PPMG ≥20 mmHg had finally a MG Conclusions Patients with PPMG >20 mmHg 1 year post-TAVI had higher 4-year mortality than the general population of the registry, unlike patients with MG normalization at 1 year. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): French National Society of Cardiology

Background: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. Objectives: The objective of this article was to perform an economic evaluation of the SENIOR trial. Methods: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. Results: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from (sic)13 752 to (sic)20 511/MACCE avoided and from (sic)42 835 to (sic)68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of (sic)50000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. Conclusion: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.

Aims The prevalence of autonomic neuropathy (AN) is high in patients with hereditary transthyretin amyloidosis but remains unknown in transthyretin wild‐type cardiac amyloidosis (ATTRwt‐CA). This study aimed to determine the prevalence of AN in patients with ATTRwt‐CA using Sudoscan®, a non‐invasive method used to provide evidence of AN in clinical practice and based on measurement of electrochemical skin conductance at the hands and feet (fESC). Methods and results A series of 62 non‐diabetic patients with ATTRwt‐CA was prospectively included over 2 years and compared with healthy elderly subjects, matched by age, gender, and body mass index. The presence of AN was defined as electrochemical skin conductance at the hands

Background It is unclear whether HIV infection affects the long‐term prognosis after an acute coronary syndrome (ACS). The objective of the current study was to compare rates of major adverse cardiac and cerebrovascular events after a first ACS between people living with HIV (PLHIV) and HIV‐uninfected (HIV−) patients, and to identify determinants of cardiovascular prognosis. Methods and Results Consecutive PLHIV and matched HIV− patients with a first episode of ACS were enrolled in 23 coronary intensive care units in France. Patients were matched for age, sex, and ACS type. The primary end point was major adverse cardiac and cerebrovascular events (cardiac death, recurrent ACS, recurrent coronary revascularization, and stroke) at 36‐month follow‐up. A total of 103 PLHIV and 195 HIV− patients (mean age, 49 years [SD, 9 years]; 94.0% men) were included. After a mean of 36.6 months (SD, 6.1 months) of follow‐up, the risk of major adverse cardiac and cerebrovascular events was not statistically significant between PLHIV and HIV− patients (17.8% and 15.1%, P =0.22; multivariable hazard ratio [HR], 1.60; 95% CI, 0.67–3.82 [ P =0.29]). Recurrence of ACS was more frequent among PLHIV (multivariable HR, 6.31; 95% CI, 1.32–30.21 [ P =0.02]). Stratified multivariable Cox models showed that HIV infection was the only independent predictor for ACS recurrence. PLHIV were less likely to stop smoking (47% versus 75%; P =0.01) and had smaller total cholesterol decreases (–22.3 versus –35.0 mg/dL; P =0.04). Conclusions Although the overall risk of major adverse cardiac and cerebrovascular events was not statistically significant between PLHIV and HIV− individuals, PLHIV had a higher rate of recurrent ACS. Registration URL: https://www.clini​caltr​ials.gov ; Unique identifier: NCT00139958.

OBJECTIVES: Report the results at 2 years of the patients included in the SENIOR trial. BACKGROUND: Patients above 75 years of age represent a fast-growing population in the cathlab. In the SENIOR trial, patients treated by percutaneous coronary intervention (PCI) with drug eluting stent (DES) and a short duration of P2Y12 inhibitor (1 and 6 months for stable and unstable coronary syndromes, respectively) compared with bare metal stents (BMS) was associated with a 29% reduction in the rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR) at 1 year. The results at 2 years are reported here. METHODS AND RESULTS: We randomly assigned 1,200 patients (596[50%] to the DES group and 604[50%] to the BMS group). At 2 years, the composite endpoint of all-cause mortality, MI, stroke and ID-TLR had occurred in 116 (20%) patients in the DES group and 131 (22%) patients in the BMS group (RR 0.90 [95%CI 0.72-1.13], p = .37). IDTLR occurred in 14 (2%) patients in the DES group and 41 (7%) patients in the BMS group (RR 0.35 [95%CI 0.16-0.60], p = .0002). Major bleedings (BARC 3-5) occurred in 27(5%) patients in both groups (RR 1.00, [95%CI 0.58-1.75], p = .99). Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52 [95%CI 0.01-1.95], p = .27). CONCLUSION: Among elderly PCI patients, a strategy combining a DES together with a short duration of DAPT is associated with a reduction in revascularization up to 2 years compared with BMS with very few late events and without any increased in bleeding complications or stent thrombosis. https://doi.org/10.1002/ccd.29159 ispartof: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS vol:97 issue:5 pages:E607-E613 ispartof: location:United States status: published

Graphical abstract, We report the case of acute hemolysis after percutaneous transmitral valve implantation in a failed mitral valve repair. Transthoracic echocardiography revealed a high velocity mild mitral regurgitation that could be responsible for the hemolysis. The implantation of a second 26-mm SAPIEN 3 valve (Edwards Lifesciences, Irvine, California) allowed complete regression of the hemolysis. (Level of Difficulty: Intermediate.), We report the case of acute hemolysis after percutaneous transmitral valve implantation in a failed mitral valve repair. Transthoracic…

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) initiation for patients with cardiogenic shock or cardiac arrest is an attractive strategy since it provides a quick restoration of organ perfusion. One major limitation of VA-ECMO is left ventricle (LV) distension which is associated with poor prognosis. To prevent or treat LV distension, LV decompression may be required. Current strategies for LV decompression have some contraindications, carry a high risk of complications and, for some of them concerns remain regarding their effectiveness. We here describe our experience in two adult patients treated with VA-ECMO in whom indirect LV unloading using pulmonary artery venting was performed for the prevention and the treatment of LV distension, respectively. The placement of the venting cannula in the pulmonary trunk was quick, easy and safe and was associated with the resolution of LV distension. These results suggest that pulmonary artery venting may be an attractive strategy for indirect LV decompression during VA-ECMO.

International audience; This cross-sectional study evaluates the association of major adverse cardiac events (MACE) integrated with fractional flow reserve as the management strategy for diabetes with outcomes in patients with ambiguous lesions who undergo angiography.Key PointsQuestionWhat are the usefulness, rate of major adverse cardiovascular events (MACE), and clinical outcomes of routinely integrating fractional flow reserve in the management strategy for patients with diabetes who undergo coronary angiography? FindingsIn this cross-sectional study of 1983 patients, overall reclassification by fractional flow rate was high and similar in patients with diabetes (41.2%) and patients without diabetes (37.5%); however, reclassification from medical treatment to revascularization was more frequent among patients with diabetes. The rate of 1-year MACE was similar in reclassified (9.7%) and nonreclassified (12.0%) patients with diabetes, and the rate of MACE of patients deferred based on fractional flow reserve was similar among those with and without diabetes. MeaningThe findings suggest that management strategies guided by fractional flow reserve, including revascularization deferral, may be useful for patients with diabetes.ImportanceApproximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned. ObjectiveTo evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography. Design, Setting, and ParticipantsThis cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018. Main Outcomes and MeasuresDeath from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year. ResultsAmong 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P=.13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P=.001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P=.37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P=.04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P=.87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status. Conclusions and RelevanceRoutine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.

Background: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. Results: In propensity–matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46–1.91]; P P P =0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06–1.29]; P =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. Conclusion: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. Clinical Trial Registration: https://www.clinicaltrials.gov . Unique identifier: NCT01777828.

Background Multimodality imaging is essential for infective endocarditis (IE) diagnosis. The aim of this work was to evaluate the agreement between transesophageal echocardiography (TEE) and cardiac computed tomography (CT) findings in patients with surgically confirmed IE. Methods Sixty-eight patients (mean age 63 ± 2 years) with a definite diagnosis of left-side IE according to the modified European Society of Cardiology Duke criteria, on both native and prosthetic valves, underwent TEE and cardiac CT before surgery. The presence of valvular (vegetations, erosion) and paravalvular (abscess, pseudoaneurysm) IE-related lesions were compared between both modalities. Perioperative inspection was used as reference. Results TEE performed better than CT in detecting valvular IE-related lesions (TEE area under the curve [AUCTEE] = 0.881 vs AUCCT = 0.720, P = .02) and was similar to CT with respect to paravalvular IE-related lesions (AUCTEE = 0.830 vs AUCCT = 0.816, P = .835). The ability of TEE to detect vegetation was significantly better than that of CT (AUCTEE = 0.863 vs AUCCT = 0.693, P = .02). The maximum size of vegetations was moderately correlated between modalities (Spearman's rho = 0.575, P Conclusions In patients with a definite diagnosis of left-side IE according to the modified European Society of Cardiology Duke criteria, TEE performed better than CT for the detection of valvular IE-related lesions and similar to CT for the detection of paravalvular IE-related lesions.

Objectives This study aimed to assess the impact of pacemaker mode programming on clinical outcomes in patients with high-degree atrioventricular conduction disturbance (AVCD) after transcatheter aortic valve implantation (TAVI). Background Although high-degree AVCD after TAVI can receive pacemaker, recovery of the AVCD is often observed. Specific pacemaker algorithms (AAI-DDD mode switch) are available which favor spontaneous atrioventricular conduction. Methods Of 1,621 consecutive multi-center TAVI patients, 269 (16.4%) received pacemaker. We retrospectively included 91 patients with persistent high-degree AVCD at hospital discharge. Pacemaker dependency was defined as absence, inadequate intrinsic ventricular rhythm, or ventricular pacing time > 95% on pacemaker interrogation during follow-up. Comparison of heart failure hospitalization and death between conventional DDD (cDDD) and other modes was examined (AAI-DDD and VVI). Results During a mean follow-up duration of 13 months, the pacemaker dependency rate was 52.8%. Patients with cDDD mode (N = 36: 40.0%) had significantly more pacemaker dependency. Multivariate analysis showed that cDDD mode was independently associated with pacemaker dependency (odds ratio = 3.63, P = 0.03). Moreover, cDDD patients had a significant higher incidence of heart failure hospitalization (Hospitalization: cDDD vs. others = 45.4% vs. 18.2%, P = 0.03) and had a higher incidence of mortality (Death: cDDD vs. the others = 27.0% vs. 4.4%, P = 0.06). Conclusions Up to half of patients implanted for high-degree AVCD after TAVI had conduction recovery. Patients with cDDD programming at hospital discharge had more pacemaker dependency and a worse cardiac prognosis. Thus, pacemaker mode should be systematically set to promote spontaneous atrioventricular conduction in patients with pacemaker implantation after TAVI.

Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme

BACKGROUND: Coronary artery disease (CAD) is common in patients undergoing transcatheter aortic valve replacement (TAVR). However, the impact of CAD distribution before TAVR on short‐ and long‐term prognosis remains unclear. HYPOTHESIS: We hypothesized that the long‐term clinical impact differs according to CAD distribution in patients undergoing TAVR using the FRench Aortic National CoreValve and Edwards (FRANCE‐2) registry. METHODS: FRANCE‐2 is a national French registry including all consecutive TAVR performed between 2010 and 2012 in 34 centers. Three‐year mortality was assessed in relation to CAD status. CAD was defined as at least 1 coronary stenosis >50%. RESULTS: A total of 4201 patients were enrolled in the registry. For the present analysis, we excluded patients with a history of coronary artery bypass. CAD was reported in 1252 patients (30%). Half of the patients presented with coronary multivessel disease. CAD extent was associated with an increase in cardiovascular risk profile and in logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (from 19.3% ± 12.8% to 21.9% ± 13.5%, P < 0.001). Mortality at 30 days and 3 years was 9% and 44%, respectively, in the overall population. In multivariate analyses, neither the presence nor the extent of CAD was associated with mortality at 3 years (presence of CAD, hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.78‐1.07). A significant lesion of the left anterior descending (LAD) was associated with higher 3‐year mortality (HR: 1.42; 95% CI: 1.10‐1.87). CONCLUSIONS: CAD is not associated with decreased short‐ and long‐term survival in patients undergoing TAVR. The potential deleterious effect of LAD disease on long‐term survival and the need for revascularization before or at the time of TAVR should be validated in a randomized control trial.

Introduction Hereditary (ATTRv) and senile (ATTRwt) transthyretin amyloidosis are severe and fatal systemic diseases, characterised by amyloid fibrillar accumulation principally in the heart or peripheral nerves (or both). Since 2012, tafamidis is used in France to treat patients with ATTRv with neuropathy (alone or with cardiomyopathy). Recently, the Phase III ATTRACT trial showed that tafamidis decreased the relative risk of mortality in ATTR amyloidosis with cardiomyopathy. Purpose The aims of this study were to assess the clinical characteristics of ATTR amyloidosis in a real-life population in comparison to the population included in the ATTRACT trial and to assess the impact of tafamidis on major cardiovascular outcome-free (MCO-free) survival time without cardiac decompensation, heart transplant, or death. Methods From June 2008 to November 2018, 648 patients with ATTR amyloidosis (423 ATTRwt and 225 ATTRv) consecutively referred to the French Referral Center for cardiac amyloidosis were included. 467 (72%) patients matched the inclusion criteria of the ATTRACT study. Results For the 631 patients with cardiomyopathy, median MCO-free survival time increased with tafamidis treatment (N = 98): 1565 (1010–2400) days vs. 771 (686–895) days without treatment (log-rank P Conclusion In a large cohort of ATTRwt and ATTRv patients, representative of the inclusion criteria of the ATTRACT trial, the present results confirm the positive impact of tafamidis treatment on preventing the occurrence of cardiovascular outcome in a real-life population.

Background Senile transthyretin amyloidosis (ATTRwt) occurs in elderly patients and leads to severe heart failure (HF). The mechanism of the disease involved cardiac and extra cardiac amyloid fibril infiltrations. Consequence of extracardiac infiltration on frailty has been poorly studied. Purpose Ours aims were to describe the frailty phenotype in ATTRwt cardiac amyloidosis (CA) patients, estimate its prevalence, and investigate associations between frailty parameters, and cardiac involvement severity and course of amyloid disease. Methods We prospectively assessed frailty, using multidimensional geriatric tools, in ATTRwt CA patients followed in the French Referral Center for CA, between April 2018 and June 2019. Results 36 patients (35 males, median age 82 years) with ATTRwt CA were included. One third of patients were in NYHA class III–IV, 39% had a left ventricular ejection fraction Table 1 ). CA severity was significantly associated (P ≤ 0.05) with numerous frailty parameters independently from age. Furthermore, poor motricity and balance impairment were also significantly associated with a longer course of amyloid disease ( Fig. 1 ). Conclusion Frailty was highly prevalent in ATTRwt CA patients. Some frailty parameters were significantly associated with a longer course of amyloid disease and CA severity independently from age. Taking in account frailty in ATTRwt assessment and management should improve their quality of life.

ATTRwt-CA occurs in elderly patients and leads to severe heart failure. The disease mechanism involves cardiac and extracardiac infiltration by amyloid fibrils. The objectives of this study are to describe the frailty phenotype in patients with ATTRwt-CA and to assess the associations between frailty parameters, the severity of cardiac involvement, and the course of amyloid disease. We used multidimensional geriatric tools to prospectively assess frailty in patients with ATTRwt-CA consulting (in 2018–2019) in the French National Reference Center for Cardiac Amyloidosis. We included 36 patients (35 males, median age: 82 years (76–86). A third of the patients were categorized as NYHA class III or IV, and 39% had an LVEF below 45%. The median serum NTproBNP was 3188 (1341–8883) pg/mL. The median duration of amyloidosis was 146 months (73–216). The frequency of frailty was 50% and 33% according to the physical frailty phenotype and the Short Emergency Geriatric Assessment questionnaire, respectively. Frailty affected a large number of domains, namely autonomy (69%), balance (58%), muscle weakness (74%), malnutrition (39%), dysexecutive syndrome (72%), and depression (49%). The severity of CA was significantly associated with many frailty parameters independently of age. Balance disorders and poor mobility were also significantly associated with a longer course of amyloid disease. Frailty is frequent in patients with ATTRwt-CA. Some frailty parameters were significantly associated with a longer course of amyloid disease and CA severity. Taking into account frailty in the assessment and management of ATTRwt should improve patients’ quality of life.

Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)

Objectives To evaluate the feasibility of coronary procedures after transcatheter aortic valve implantation (TAVI) with the CoreValve™ device. Background Due to its design, CoreValve™ prosthesis may interfere with coronary procedures. Data on this issue are sparse. Methods Between 2007 and 2015, 550 patients underwent CoreValve™ TAVI in our hospital. Among them, 16 underwent coronary angiogram after TAVI and were included in our retrospective study. For each patient, we compared the characteristics of coronary angiograms performed before and after TAVI. Results Coronary angiogram was deemed successful in 9 patients. The mean number of different catheters used in attempts to cannulate the coronary arteries was 3.6 ± 1.4 and the rate of selective intubation was low. Fluoroscopy time (13.2 ± 5.8 vs. 7.2 ± 4.6 min, P = 0.003), dose area product (5,347 ± 4,919 vs. 3,433 ± 3,420 cGy/m2, P = 0.004), and contrast volume (157.7 ± 69.6 vs. 108.3 ± 42.6 mL, P = 0.006) were more important in coronary angiograms performed after CoreValve™ implantation. Percutaneous coronary intervention was successfully performed in 6 out of 7 patients who required it. Conclusion Coronary procedures after CoreValve™ TAVI are feasible, but challenging. This problem is currently rare but will be more common as the indications of TAVI are expanded to younger patients with longer life expectancies. Recommendations for post-TAVI coronary procedures are needed, particularly for centers unfamiliar with the management of post-TAVI patients.