Predictors of clinical success after transcatheter para-valvular leak closure: an international prospective multicentre registry

International audienceAbstract Background Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and haemolysis, for which the standard treatment is open-heart surgery with the attendant risks to the patient. Transcatheter closure has emerged as an alternative. Patient selection criteria for the best option are needed. We aimed to identify predictors of clinical success after transcatheter PVL closure. Purpose We aimed to identify predictors of clinical success after transcatheter PVL closure. Methods Consecutive patients referred to 24 European centres for transcatheter PVL closure in 2017–2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. Results We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. The prosthesis was mechanical in 53.3% and biological in 45.3% of procedures. All patients were symptomatic with heart failure, haemolytic anaemia, and the association of both conditions in 48.9%, 7.8% and 43.3%. One, two and three PVL were addressed during the same procedure in 69.6%, 26.6% and 3.8% respectively. Mitral and aortic PVL were severe in 35.3% and 13.8% (p<0.001). PVL was punctiform or extended to 1/8 or 1/4 of valve circumference in 18.6%, 52.4% and 28.1% of cases. A total of 331 devices were implanted. More than one device (up to 5) was implanted in 34.2% of procedures. Vascular plug 3, muscular ventricular septal defect occluder, vascular plug 2 and paravalvular leak device were the most frequently used devices, implanted in 45.0%, 16.0%, 14.2% and 13.6%, respectively. Successful device(s) implantation(s) within the leak and leak reduction ≤ grade 2 occurred in 85.0% and 91.4% of patients with mitral and aortic procedures, respectively (p=0.164), with major intra-procedural adverse event rates of 3.3% and 1.2%, respectively (p=0.371). The clinical success rates were 77.8% and 88.9% following mitral and aortic procedures, respectively (p=0.01). By multivariate logistic regression analysis, technical failure, mechanical valve and haemolytic anaemia were independently associated with absence of clinical success (odds ratios [95% CIs]: 7.7 [2.0–25.0], p=0.002; 3.6 [1.1–11.1], p=0.036 and 3.7 [1.2–11.9], p=0.025; respectively). Conclusion Transcatheter PVL closure is efficient and safe in symptomatic patients but is more challenging and associated with an increased risk of clinical failure when performed in patients with hemolysis and/or on a mechanical valve

Supplementary Material for: Clopidogrel Use as Single Antiplatelet Therapy in Outpatients with Stable Coronary Artery Disease: Prevalence, Correlates and Association with Prognosis (from the CORONOR Study)

<b><i>Background:</i></b> Clopidogrel use as single antiplatelet therapy (SAPT) has never been evaluated in stable coronary artery disease (CAD) outpatients either as compared to placebo or aspirin. <b><i>Methods:</i></b> We therefore studied 2,823 outpatients included in a prospective registry. The patients were divided into 2 groups according to their antiplatelet therapy regimen: patients treated with clopidogrel were compared with those treated with aspirin alone. <b><i>Results:</i></b> The mean time since CAD diagnosis was 7.9 years. Altogether, 776 (27.5%) patients received clopidogrel as SAPT. Factors independently associated with clopidogrel use were prior aortic or peripheral intervention, drug-eluting stent implantation, stroke, carotid endarterectomy and time since CAD diagnosis. Clopidogrel tended to be used in higher-risk patients: composite of cardiovascular death, myocardial infarction or stroke at 5.8 versus 4.2% (p = 0.056). However, after propensity score matching, similar event rates were observed between the groups: 5.9% when treated with clopidogrel versus 4.4% with aspirin (p = 0.207). The rate of bleeding was also similar between the groups. <b><i>Conclusions:</i></b> Our study shows that a significant proportion of stable CAD patients are treated with clopidogrel as SAPT in modern practice. Several correlates of such an attitude were identified. Our results suggest that this strategy is not beneficial as compared to aspirin alone in terms of ischaemic or bleeding events

Relationship Between Arterial Access and Outcomes in ST-Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM) Study.

BACKGROUND: The effectiveness of radial access (RA) in ST-elevation myocardial infarction (STEMI) has been predominantly established in primary percutaneous coronary intervention (pPCI) with limited exploration of this issue in the early postfibrinolytic patient. The purpose of this study was to compare the effectiveness and safety of RA versus femoral (FA) access in STEMI undergoing either a pharmacoinvasive (PI) strategy or pPCI. METHODS AND RESULTS: Within STrategic Reperfusion Early After Myocardial Infarction (STREAM), we evaluated the relationship between arterial access site and primary outcome (30-day composite of death, shock, congestive heart failure, or reinfarction) and major bleeding according to the treatment strategy received. A total of 1820 STEMI patients were included: 895 PI (49.2%; rescue PCI [n=379; 42.3%], scheduled PCI [n=516; 57.7%]) and 925 pPCI (50.8%). Irrespective of treatment strategy, there was comparable utilization of either access site (FA: PI 53.4% and pPCI 57.6%). FA STEMI patients were younger, had lower presenting systolic blood pressure, lesser Thrombolysis In Myocardial Infarction risk, and more ∑ST-elevation at baseline. The primary composite endpoint occurred in 8.9% RA versus 15.7% FA patients (P<0.001). On multivariable analysis, this benefit on the primary composite outcome favoring RA persisted (adjusted odds ratio [OR], 0.59; 95% CI, 0.44-0.78; P<0.001) and was evident in both pPCI (adjusted OR, 0.63; 95% CI, 0.43-0.92) and PI cohorts (adjusted OR, 0.57 95% CI, 0.37-0.86; P interaction=0.730). There was no difference in nonintracranial major bleeding with either access group (RA vs FA, 5.2% vs 6.0%; P=0.489). CONCLUSIONS: Regardless of the application of a PI or pPCI strategy, RA was associated with improved clinical outcomes, supporting current STEMI evidence in favor of RA in PCI. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00623623

Chronic coronary syndromes without standard modifiable cardiovascular risk factors and outcomes: the CLARIFY registry

Background and Aims: It has been reported that patients without standard modifiable cardiovascular (CV) risk factors (SMuRFs—diabetes, dyslipidaemia, hypertension, and smoking) presenting with first myocardial infarction (MI), especially women, have a higher in-hospital mortality than patients with risk factors, and possibly a lower long-term risk provided they survive the post-infarct period. This study aims to explore the long-term outcomes of SMuRF-less patients with stable coronary artery disease (CAD). Methods: CLARIFY is an observational cohort of 32 703 outpatients with stable CAD enrolled between 2009 and 2010 in 45 countries. The baseline characteristics and clinical outcomes of patients with and without SMuRFs were compared. The primary outcome was a composite of 5-year CV death or non-fatal MI. Secondary outcomes were 5-year all-cause mortality and major adverse cardiovascular events (MACE—CV death, non-fatal MI, or non-fatal stroke). Results: Among 22 132 patients with complete risk factor and outcome information, 977 (4.4%) were SMuRF-less. Age, sex, and time since CAD diagnosis were similar across groups. SMuRF-less patients had a lower 5-year rate of CV death or non-fatal MI (5.43% [95% CI 4.08–7.19] vs. 7.68% [95% CI 7.30–8.08], P = 0.012), all-cause mortality, and MACE. Similar results were found after adjustments. Clinical event rates increased steadily with the number of SMuRFs. The benefit of SMuRF-less status was particularly pronounced in women. Conclusions: SMuRF-less patients with stable CAD have a substantial but significantly lower 5-year rate of CV death or non-fatal MI than patients with risk factors. The risk of CV outcomes increases steadily with the number of risk factors