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Background: Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce., Aims: We aimed to report procedural safety and long-term clinical events (CE) in a contemporary cohort of PAVR patients treated with new-generation devices (NGD)., Methods: Patients with grade III/IV PAVR enrolled in the FRANCE-TAVI Registry were selected. The primary safety endpoint was technical success (TS) according to Valve Academic Research Consortium 3 criteria. The co-primary endpoint was defined as a composite of mortality, heart failure hospitalisation and valve reintervention at last follow-up., Results: From 2015 to 2021, 227 individuals (64.3% males, median age 81.0 [interquartile range {IQR} 73.5-85.0] years, with EuroSCORE II 6.0% [IQR 4.0-10.9]) from 41 centres underwent TAVI with NGD, using either self-expanding (55.1%) or balloon-expandable valves (44.9%; p=0.50). TS was 85.5%, with a non-significant trend towards increased TS in high-volume activity centres. A second valve implantation (SVI) was needed in 8.8% of patients, independent of valve type (p=0.82). Device size was ≥29 mm in 73.0% of patients, post-procedure grade ≥III residual aortic regurgitation was rare (1.2%), and the permanent pacemaker implantation (PPI) rate was 36.0%. At 30 days, the incidences of mortality and reintervention were 8.4% and 3.5%, respectively. The co-primary endpoint reached 41.6% (IQR 34.4-49.6) at 1 year, increased up to 61.8% (IQR 52.4-71.2) at 4 years, and was independently predicted by TS, with a hazard ratio of 0.45 (95% confidence interval: 0.27-0.76); p=0.003., Conclusions: TAVI with NGD in PAVR patients is efficient and reasonably safe. Preventing the need for an SVI embodies the major technical challenge. Larger implanted valves may have limited this complication, outweighing the increased risk of PPI. Despite successful TAVI, PAVR patients experience frequent CE at long-term follow-up.

Background and Aims: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries., Methods: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety., Results: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%)., Conclusions: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited., Aims: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry., Methods: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria., Results: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm 2 , and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies., Conclusions: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Background: Limited data are available regarding the optimal management and prognosis of patients with cancer who develop an acute myocardial infarction., Aim: The objective of this study was to analyse the characteristics and outcomes of patients according to cancer and myocardial infarction occurrence., Methods: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients seen in French hospitals in 2013, excluding those with a history of myocardial infarction. The population was divided into two groups according to their history of cancer. We studied the following outcomes: all-cause and cardiovascular mortality; acute myocardial infarction; and ischaemic stroke. Data were collected after a 5-year follow-up., Results: Between 2013 and 2019, 3,381,472 patients were seen in French hospitals; among them, 3,323,757 had no history of myocardial infarction. Patients with a history of cancer (n=497,593) had higher incidences of all-cause mortality (17.82%/year vs 3.79%/year), cardiovascular mortality (1.61%/year vs 1.17%/year), myocardial infarction (0.82%/year vs 0.61%/year) and ischaemic stroke (0.91%/year vs 0.62%/year) compared with patients without cancer (n=2,826,164). After performing an adjusted competing-risk analysis, the cumulative incidence of acute myocardial infarction, cardiovascular death and ischaemic stroke incidence was found to be lower in patients with a history of cancer, whereas death of non-cardiac origin was more prevalent in patients with a history of cancer., Conclusions: In this observational study, we have shown that patients with cancer have a higher incidence of all-cause mortality, cardiovascular mortality and myocardial infarction. However, multivariable analysis showed a lower cumulative incidence of these events., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Background: Management of mitral regurgitation recurrence after failed surgical valve repair with ring implantation is controversial., Aim: To describe the French experience regarding midterm safety and efficacy of transcatheter edge-to-edge mitral valve repair (TEER) in patients with failed surgical valve repair with ring implantation., Methods: The "Clip-in-Ring" registry is a multicentre registry conducted in 11 centres in France, approved by local institutional review boards, of consecutive TEER following surgical valve repair with ring implantation. Outcomes were Mitral Valve Academic Research Consortium (MVARC) technical success, modified 30-day device and procedural success (where 10mmHg is considered as a cut-off for significant mitral stenosis) and MVARC complications., Results: Twenty-three patients were studied: mean age, 69±10years; male sex, 74%; EuroSCORE II, 16±17; left ventricular ejection fraction, 53±12%; mitral regurgitation grade 3+/4+, 17%/78%; New York Heart Association class III/IV, 47%/22%; median surgery to TEER delay, 23 (6-94) months. Technical success was 100%. At discharge, residual mitral regurgitation grade was≤2+ in 87% and median transmitral gradient was 4 (3-5) mmHg. Thirty-day modified MVARC device and procedural success was 82%: four patients (17%) had residual mitral regurgitation grade>2+, including two patients who needed complementary surgery. No patient had a 30-day transmitral gradient>7mmHg. No patient died or had a stroke or any life-threatening complications. One patient presented a vascular access complication requiring transfusion. No other MVARC-2 adverse event was reported., Conclusions: TEER in patients with failed mitral ring is feasible and safe. Further studies should delineate its exact role in the therapeutic armamentarium for this medical issue., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Early mortality post-ST-segment elevation myocardial infarction (STEMI) in France remains high. The multicentre France Percutaneous Coronary Intervention Registry includes every patient undergoing coronary angiography in France. We analyzed the prevalence and impact of unmodifiable and modifiable risk factors on 30-day survival in patients experiencing STEMI. Patients admitted for STEMI between 01/2014 and 12/2016 were included in the analysis. Patients with nonobstructive coronary artery disease, with cardiogenic shock or cardiac arrest without STEMI, were excluded. Prehospital, clinical and procedural data were collected prospectively by the cardiologist in the cath lab using medical reporting software. Information on outcomes, including mortality, was obtained by a dedicated research technician by phone calls or from medical records. Marginal Cox proportional hazards regression was used to test the predictive value for survival at 30 days in a multivariable analysis. Included were 2590 patients (74% men) aged 63 ± 14 years. During the first month, 174 patients (6.7%) died. After adjustment, unmodifiable variables significantly associated with reduced 30-day survival were: age > 80 years (prevalence 15%; hazard ratio [HR] 2.7; 95% confidence interval [CI] 1.5-4.7), chronic kidney disease (2%; HR 5.3; 95% CI 2.6-11.1), diabetes mellitus (14%; HR 1.6; 95% CI 1.0-2.5), anterior or circumferential electrical localization (39%; HR 2.0; 95% CI 1.4-2.9), and Killip class 2, 3, or 4 (7%; HR 3.4; 95% CI 1.9-5.9; 2%; HR 10.1; 95% CI 5.3-19.4; 4%; HR 18; 95% CI 10.8-29.8, respectively). Among modifiable variables, total ischemic time > 3 hours (68%; HR 1.8; 95% CI 1.1-3.0), lack of appropriate premedication (18%; HR 2.2; 95% CI 1.5-3.3), and post-PCI TIMI < 3 (6%; HR 4.9; 95% CI 3.2-7.6) were significantly associated with reduced 30-day survival. Most predictors of 30-day survival post-STEMI are unmodifiable, but outcomes might be improved by optimizing modifiable factors, most importantly ischemic time and appropriate premedication., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: We sought to compare, in a national French registry (FrancePCI), the clinical impact of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with angio-guided PCI at 1 year., Background: FFR has become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide PCI compared to angiography (angio)., Methods: We extracted from the FrancePCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE)., Results: Fourteen thousand three hundred eighty-four patients with 1-year clinical follow-up were included. Among them, 13,125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11.3%) versus 100 (7.9%) (p < 0.0001), respectively, with hazard ratio (HR) of 1.440, 95% confidence interval (CI) [1.211-1.713] (p = 0.0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3.9%) versus 17 (1.4%) (p < 0.0001), respectively, with HR of 2.845, 95% CI [2.099-3.856] (p < 0.0001). After adjustment for potential confounding factors, HRs were 1.287, 95% CI [1.028-1.613] (p = 0.028) for MACE and 2.527, 95% CI [1.452-4.399] (p = 0.001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints., Conclusions: FFR-guided PCI improves outcome at 1 year compared to angio-guided PCI with a reduction of 64% of death., (© 2022 Wiley Periodicals LLC.)

Ventricular septal myectomy (SM) and alcohol septal ablation (ASA), 2 septal reduction therapies (SRTs), are recommended in symptomatic obstructive hypertrophic cardiomyopathy (HCM) despite maximum tolerated medical therapy. Contradictory results between the outcomes of these 2 types of therapies persist to this day. The objective of this study was to compare in-hospital and mid-term outcomes of SM versus ASA, at a nationwide level in France. We collected information on patients who underwent SRT for HCM using the French nationwide Programme de Médicalisation des Systèmes d'Information database between 2010 and 2019. A total of 1,574 patients were identified in the database, including 340 patients in the SM arm and 1,234 patients in the ASA arm. No difference during the median follow-up of 1.3 years between the 2 groups was noted in terms of mortality (adjusted incidence rate ratio 0.687, 95% confidence interval 0.361 to 1.309, p = 0.25). However, there was a significantly lower risk of all-cause stroke (adjusted incidence rate ratio 0.180, 95% confidence interval 0.058 to 0.554, p = 0.003) in the ASA group. In conclusion, in our "real-life" data from France, mortality after SRT in patients with HCM was similar after ASA or SM. Moreover, ASA was more widely used than SM despite European Society of Cardiology guidelines recommendations., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials., Objectives: The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention., Methods: From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year., Results: Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41-11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12-2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71-3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14-4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24-3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04-15.06; p < 0.001)., Conclusions: Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population., Clinical Trial Registration: Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov ., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.)

Mitral regurgitation (MR) is the most common valvular lesion in transcatheter aortic valve implantation (TAVI) recipients. This study aims to assess the long-term prognostic impact of baseline MR in TAVI patients., Methods: Adult patients who underwent TAVI were identified in the French National Hospital Discharge Database. All-cause and cardiovascular mortality, stroke, and rehospitalization with heart failure (HF) were compared in TAVI patients with and without baseline MR and tricuspid regurgitation (TR), respectively; the associations of MR and TR with the outcomes were assessed by Cox regression., Results: Baseline MR was identified in 8240 TAVI patients. Patients with baseline MR have higher yearly incidence of all-cause mortality (HR: 1.192, 95% confidence interval CI: 1.125-1.263), cardiovascular mortality (HR: 1.313, 95%CI: 1.210-1.425), and rehospitalization for heart failure (HF) (HR: 1.411, 95%CI: 1.340-1.486) compared to those without, except for stroke rate (HR: 0.988, 95%CI: 0.868-1.124). Neither baseline MR nor TR was an independent risk predictor for all-cause mortality or cardiovascular mortality in TAVI patients. Baseline MR was independently associated with rehospitalization for HF in TAVI patients., Conclusions: Baseline MR and TR were associated with increased all-cause and cardiovascular mortality post-TAVI, however, neither of them was independent predictor for all-cause or cardiovascular mortality.

Aims: A greater number of patients with bicuspid aortic valves (BAV) may be identified and treated as indications for transcatheter aortic valve implantation (TAVI) are expected to expand to younger patients. We evaluated the contemporary frequency and management of symptomatic patients with stenotic BAV in a multicenter European registry., Methods: Between November 2017 and February 2018, all consecutive patients admitted for symptomatic aortic stenosis across six high-volume European hospitals were prospectively enrolled in the BiTri registry., Results: Of the 832 patients, 17% (n = 138) had a BAV. The most frequent BAV phenotypes were type 1 (left--right coronary cusps fusion 64%) and type 1 (right-noncoronary cusps fusion 17%). Type 0 and type 2 accounted for 12 and 2%, respectively. When compared with tricuspid patients (n = 694), BAV patients were younger, with lower surgical risk. The transthoracic echocardiography (TTE) identified BAV in 64% of patients. Multisliced computed tomography (MSCT) additionally completed the diagnosis in 20% of patients. Surgical inspection finally identified the remaining undiagnosed 16% of BAV. A combination of TTE and MSCT was the most common diagnosis method for BAV. Surgical aortic valve replacement (SAVR) was the predominant therapeutic option for BAV (70%) whilst TAVI was performed in 26%., Conclusion: BAV is frequently observed in symptomatic patients with aortic stenosis. These patients are younger, have a lower risk profile and are predominantly treated with SAVR as compared with tricuspid patients. However, TAVI is performed in almost one-third of BAV patients in contemporary European practice. TTE combined with MSCT identified 84% of BAV., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Although many risk models have been tested in patients implanted by veno-arterial extracorporeal membrane oxygenation (VA-ECMO), few scores assessed patients' prognosis in the setting of ST-segment elevation myocardial infarction (STEMI) with refractory cardiogenic shock. We aimed at assessing the performance of risk scores, notably the prEdictioN of Cardiogenic shock OUtcome foR AMI patients salvaGed by VA-ECMO (ENCOURAGE) score, for predicting mortality in this particular population. This retrospective observational study included patients admitted to Tours University Hospital for STEMI with cardiogenic shock and requiring hemodynamic support by VA-ECMO. Among the fifty-one patients, the 30-day and 6-month survival rates were 63% and 56% respectively. Thirty days after VA-ECMO therapy, probabilities of mortality were 12, 17, 33, 66, 80% according to the ENCOURAGE score classes 0-12, 13-18, 19-22, 23-27, and ≥28, respectively. The ENCOURAGE score (AUC of the Receiving Operating Characteristic curve = 0.83) was significantly better compared to other risk scores. The hazard ratio for survival at 30 days for each point of the ENCOURAGE score was 1.10 (CI 95% (1.06, 1.15); p < 0.001). Decision curve analysis indicated that the ENCOURAGE score had the best clinical usefulness of the tested risk scores and the Hosmer-Lemeshow test suggested an accurate calibration. Our data suggest that the ENCOURAGE score is valid and the most relevant score to predict 30-day mortality after VA-ECMO therapy in STEMI patients with refractory cardiogenic shock. It may help decision-making teams to better select STEMI patients with shock for VA-ECMO therapy.

Background: ST-elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) are associated with a worse prognosis. However, few comparisons are available according to coronary status in the era of modern reperfusion and optimized secondary prevention., Hypothesis: We hypothesized that the difference in prognosis according to number of vessel disease in STEMI patients has reduced., Methods: All consecutive STEMI patients undergoing primary percutaneous coronary intervention (PCI) within 24 h of symptoms onset between January 1, 2014 and June 30, 2016 enrolled in the CRAC (Club Régional des Angioplasticiens de la région Centre) France PCI registry were analyzed. Baseline characteristics, management, and outcomes at 1-year were analyzed according to coronary status (one-, two-, and three-VD)., Results: A total of 1886 patients (mean age 62.2 ± 14.0 year; 74% of male) were included. Patients with MVD (two or three-VD) represented 53.7%. They were older with higher cardiovascular risk factor profile. At 1 year, the rate of major adverse cardiovascular events (MACE, defined as all-cause death, stroke or re-MI) was 10%, 12%, and 12% in one-, two, and three-VD respectively (p = .28). In multivariable adjusted Cox proportional hazard regression model, two- and three-VD were not associated with higher rate of MACE compared to patients with single VD (HR, 1.09; 95%CI 0.76-1.56 for two-VD; HR, 0.74; 95%CI 0.48-1.14 for three-VD)., Conclusions: MVD still represents an important proportion of STEMI patients but their prognoses were not associated with worse clinical outcomes at 1-year compared with one-VD patients in a modern reperfusion area and secondary medication prevention., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Background: Valve-in-valve transcatheter aortic valve implantation (TAVI) has emerged as a treatment for aortic bioprosthesis failure in case of prohibitive risk for redo surgery. However, clinical evaluation of valve-in-valve TAVI remains limited by the number of patients analysed., Aim: To evaluate outcomes of valve-in-valve TAVI compared with native aortic valve TAVI at a nationwide level in France., Methods: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated with TAVI for aortic stenosis or with isolated valve-in-valve TAVI for aortic bioprosthesis failure between 2010 and 2019. Propensity score matching was used for the analysis of outcomes., Results: A total of 44,218 patients were found in the database. After matching on baseline characteristics, 2749 patients were analysed in each arm. At 30 days, no significant differences were observed regarding the occurrence of major clinical events (composite of cardiovascular mortality, all-cause stroke, myocardial infarction, major or life-threatening bleeding and conversion to open heart surgery) (odds ratio [OR] 0.83, 95% confidence interval [CI] 0.68-1.01; P=0.32). During follow-up (mean 516 days), the combined endpoint of cardiovascular death, all-cause stroke or rehospitalization for heart failure was not different between the valve-in-valve TAVI and native TAVI groups (RR 1.03, 95% CI 0.94-1.13; P=1.00)., Conclusion: We observed that valve-in-valve TAVI was associated with good short- and long-term outcomes. No significant differences were observed compared with native valve TAVI regarding clinical follow-up., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Aims: The aim of this study was to analyse delays in emergency medical system transfer of ST-segment elevation myocardial infarction (STEMI) patients to percutaneous coronary intervention (PCI) centres according to transport modality in a rural French region., Methods and Results: Data from the prospective multicentre CRAC / France PCI registry were analysed for 1911 STEMI patients: 410 transferred by helicopter and 1501 by ground transport. The primary endpoint was the percentage of transfers with first medical contact to primary percutaneous coronary intervention within the 90 minutes recommended in guidelines. The secondary endpoint was time of first medical contact to primary percutaneous coronary intervention. With helicopter transport, time of first medical contact to primary percutaneous coronary intervention in under 90 minutes was less frequently achieved than with ground transport (9.8% vs. 37.2%; odds ratio 5.49; 95% confidence interval 3.90; 7.73; P <0.0001). Differences were greatest for transfers under 50 km (13.7% vs. 44.7%; P <0.0001) and for primary transfers (22.4% vs. 49.6%; P <0.0001). The median time from first medical contact to primary percutaneous coronary intervention and from symptom onset to primary percutaneous coronary intervention (total ischaemic time) were significantly higher in the helicopter transport group than in the ground transport group (respectively, 137 vs. 103 minutes; P <0.0001 and 261 vs. 195 minutes; P <0.0001). There was no significant difference in inhospital mortality between the helicopter and ground transport groups (6.9% vs. 6.6%; P =0.88)., Conclusions: Helicopter transport of STEMI patients was five times less effective than ground transport in maintaining the 90-minute first medical contact to primary percutaneous coronary intervention time recommended in guidelines, particularly for transfer distances less than 50 km.

Objective: Vascular complications (VCs) occurring in transcatheter aortic valve implantation (TAVI) procedures have frequently been reported in the past. Considering significant technical improvements in delivery systems and vascular closure devices, the goal of this study was to determine the incidence, impact, and prognostic factors of VCs in a recent real-world cohort., Methods: We report a bicentric prospective analysis of 479 consecutive patients who underwent TAVI between January 2017 and December 2017. VCs were defined according to criteria set out by the Valve Academic Research Consortium (VARC)-2., Results: The incidence of VCs was 26.1% (n = 125 patients), of which 2.9% were major (n = 14) and 23.2% were minor (n = 111). VCs were related to the primary puncture point in 69% of cases compared with 31% at the secondary puncture site. Treatments implemented were medical in 76% of cases and surgical in 24% of cases. The risk factors for VCs were as follows: iliac morphology score, sheath to iliofemoral artery ratio (SIFAR), and moderate-severe iliofemoral calcifications or tortuosity. In the case of major VCs, only sheath to iliofemoral artery ratio was a risk factor. Major VCs significantly increased intrahospital mortality (30.7% vs 1.1% for minor VCs and 1.3% for no VCs; log-rank, P < .0001) and 1-year mortality (40.6% vs 5.6% for minor VCs and 5.6% for no VCs; log-rank, P < .0001)., Conclusions: Using strictly VARC-2 end point definitions, more than one-quarter of TAVI procedures were associated with VCs, primarily minor ones. Secondary puncture points were responsible for one-third of VCs and should therefore also be actively monitored. Major VCs have a significant impact on short-term and midterm survival., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y 12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting., Methods: Assessment of Loading with the P2Y 12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier)., Conclusion: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with early and later generation prostheses remains debated. Methods and Results Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. A total of 49 201 patients with aortic stenosis treated with TAVR using the balloon-expandable (BE) Edwards SAPIEN valve (early Sapien XT and latest Sapien 3) or the self-expanding (SE) Medtronic CoreValve (early CoreValve and latest Evolut R) were found in the database. Mean (SD) follow-up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1-2.0] years). PPI after the procedure was reported in 13 289 patients, among whom 11 010 (22.4%) had implantation during the first 30 days. In multivariable analysis, using early BE TAVR as reference, adjusted odds ratio (95% CI) for PPI during the first 30 days was 0.88 (0.81-0.95) for latest BE TAVR, 1.40 (1.27-1.55) for early SE TAVR, and 1.17 (1.07-1.27) for latest SE TAVR. Compared with early BE TAVR, the adjusted hazard ratio for PPI during the whole follow-up was 1.01 (0.95-1.08) for latest BE TAVR, 1.30 (1.21-1.40) for early SE TAVR, and 1.25 (1.18-1.34) for latest SE TAVR. Conclusions In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow-up.

Aims: The aim of this study was to describe the midterm outcomes in nonagenarians undergoing transcatheter aortic valve implantation (TAVI)., Methods and Results: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients with aortic stenosis (AS), and specifically those treated with TAVI between 2010 and 2018. Cox regression was used for the analysis of predictors of events. We compared patients according to their age. Within the studied period, 71,095 patients older than 90 years with AS were identified. After matching on baseline characteristics, TAVI was associated with lower rates of a combined outcome of all-cause death, rehospitalisation for heart failure and stroke (relative risk [RR] 0.58, p<0.001) in comparison with matched nonagenarians with AS treated medically. During follow-up (median 161 days, interquartile range 13-625), the combined outcome occurred more frequently in nonagenarians (RR 1.22, p<0.01) who had a TAVI than in younger patients undergoing this procedure. All-cause death was reported in 17.6% versus 14.5% of nonagenarians, rehospitalisation for heart failure in 21.3% versus 18.2%, and stroke in 3.7% versus 2.9% (p<0.01 for all parameters). We identified the Charlson comorbidity index, heart failure, atrial fibrillation, stroke, vascular disease, cognitive impairment and denutrition as independent predictors of adverse outcomes in nonagenarians undergoing TAVI., Conclusions: Among nonagenarians with AS, patients treated with TAVI had a lower risk of cardiovascular events than matched patients treated medically. The patients undergoing a TAVI at this age were often highly selected; the procedure was associated with acceptable long-term outcomes.

Background: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices., Methods: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France., Results: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10-599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P =0.005), cardiovascular death (relative risk, 0.82; corrected P =0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P <0.0001). BE TAVR was also associated with lower rates of pacemaker implantation after the procedure (relative risk, 0.72; corrected P <0.0001)., Conclusions: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.

Aims: The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial., Methods and Results: At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm 2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30)., Conclusions: In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone., (© 2019 The Authors. European Journal of Heart Failure © 2019 European Society of Cardiology.)

Background and Objective: Chronic total occlusion (CTO) guidewire have been recently reported as an alternative to radiofrequency for perforating atretic pulmonary valve. Since procedure failures or perforation of the right ventricle still occurred with CTO, we tried to enhance the stability, steering, and pushability of the wire using a microcatheter in order to improve the safety and efficacy of the procedure., Methods: We performed pulmonary valve perforation with CTO guidewire and microcatheter in five consecutive newborns with pulmonary atresia with intact ventricular septum (PA-IVS) under fluoroscopic and echocardiographic control., Results: The valve was easily perforated at the first attempt for all patients. After perforation, the microcatheter positioned in the main pulmonary artery allowed the exchange of the CTO guidewire for a more flexible wire, avoiding lesion and facilitating manipulation in the distal pulmonary branch arteries. The pulmonary valve was then dilated with balloons of increasing size as usually performed. We did not experience any procedural or early complications. Blalock-Taussig shunt was performed in 2 children because of a persistent cyanosis, 4 and 10 days after perforation., Conclusions: The combined use of a CTO guide and a microcatheter appears to be a safe and reliable technique for perforating the pulmonary valve of newborns with PA-IVS. Further procedures with this approach are needed to confirm this first experience., (© 2019 Wiley Periodicals, Inc.)

Background: It is critical to minimize the time between the first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction., Aims: To identify factors associated with a delay of>120min between first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction., Methods: Data were analysed from a regional French registry of patients undergoing coronary angioplasty for ST-segment elevation myocardial infarction<24h after symptom onset. Patients (n=2081) were grouped according to transfer times from first medical contact to primary percutaneous coronary intervention:>120min; or≤120min. Independent predictors of delay were identified by univariate and multivariable analyses., Results: The median transfer time from first medical contact to primary percutaneous coronary intervention was 112min; 892 patients (42.9%) had a transfer time>120min. A delay of>120min was significantly associated with:≥75km distance from interventional cardiology centre at symptom onset (odds ratio 7.9); more than one medical practitioner involved before interventional cardiology centre (odds ratio 4.5); first admission to a hospital without an interventional cardiology centre (odds ratio 2.9); absence of emergency call (odds ratio 1.6); ≥90min between symptom onset and first medical contact (odds ratio 1.3); Killip class at admission>1 (odds ratio 1.8); lateral ischaemia (odds ratio 1.8); diabetes mellitus (odds ratio 1.6); and hypertension (odds ratio 1.3)., Conclusions: In ST-segment elevation myocardial infarction, a transfer time from first medical contact to primary percutaneous coronary intervention of>120min was associated with geographic, systemic and comorbid factors, several of which appear reasonably actionable., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Background: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown., Methods: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm 2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months., Results: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56)., Conclusions: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).

Purpose: To compare the clinical, angiographic, therapeutic and prognostic characteristics of nonagenarians presenting with non-ST elevation acute coronary syndrome with those of patients under 90 years of age., Methods: We used the CRAC register database including 6 catheterization laboratories in the Center Val-de-Loire region. Only patients with positive-troponin non-ST elevation ACS included in the registry from 2014 to 2017 were selected for epidemiological and procedural data. Regarding antiplatelet therapy, hospital and one-year follow-up data, only patients in the 2014-2015 period were analyzed., Results: From January 1st, 2014 to December 31st, 2017, 5.964 patients with a positive-troponin non-ST ACS, including 133 nonagenarians (2.2%) were included in the CRAC registry. Arterial hypertension and the history of coronary angioplasty were more common among nonagenarians. They present more multivessel and left main disease. The use of the bare metal stent was predominant in 2014-2015 and then became marginal in 2016-2017. Clopidogrel was the most widely used anti platelet and more than one in two nonagenarians remain on dual therapy after 12 months. One-year stroke and hospital and one-year mortality were higher in this age group., Conclusions: Nonagenarians with a positive-troponin non-ST elevation ACS have more severe coronary artery disease and a poorer prognosis than those younger than 90 years of age., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)