Evolution of REperfusion Strategies and impact on mortality in Old and Very OLD STEMI patients. The RESOVOLD-e-MUST study.

BACKGROUND: The use of myocardial reperfusion-mainly via angioplasty-has increased in our region to over 95%. We wondered whether old and very old patients have benefited from this development. METHODS: Setting: Greater Paris Area (Ile-de-France). DATA: Regional registry, prospective, including since 2003, data from 39 mobile intensive care units performing prehospital treatment of patients with ST segment elevation myocardial infarction (STEMI) (<24 h). PARAMETERS: Demographic, decision to perform reperfusion and outcome (in-hospital mortality). PRIMARY ENDPOINT: Reperfusion decision rate by decade over age 70. SECONDARY ENDPOINT: Outcome. RESULTS: We analysed the prehospital management of 27,294 patients. There were 21,311 (78%) men and 5,919 (22%) women with a median age of 61 (52-73 years). Among these patients, 8,138 (30%) were > 70 years, 3,784 (14%) > 80 years and 672 (2%) > 90 years.The reperfusion decision rate was 94%. It decreased significantly with age: 93, 90 and 76% in patients in their seventh, eighth and ninth decade, respectively. The reperfusion decision rate increased significantly over time. It increased in all age groups, especially the higher ones. Mortality was 6%. It increased significantly with age: 8, 16 and 25% in patients in their seventh, eighth and ninth decade, respectively. It significantly decreased over time in all age groups. The odds ratio of the impact of reperfusion decision on mortality reached 0.42 (0.26-0.68) in patients over 90 years. CONCLUSION: the increase in the reperfusion decision rate was the greatest in the oldest patients. It reduced mortality even in patients over 90 years of age.

Improving access to transcatheter aortic valve implantation across Europe by restructuring cardiovascular services: An expert council consensus statement.

Transcatheter aortic valve implantation (TAVI) is recommended for a growing range of patients with severe aortic stenosis in the European Society of Cardiology and European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2021 Guidelines update. However, guideline implementation programs are needed to ensure the application of clinical recommendations which will favorably influence disease outcomes. An Expert Council was convened to identify whether cardiology services across Europe are set up to address the growing needs of patients with severe aortic stenosis for increased access to TAVI by identifying the key challenges faced in growing TAVI programs and mapping associated solutions. Wide variation exists across Europe in terms of TAVI availability and capacity to deliver the increased demand for TAVI in different countries. The recommendations of this Expert Council focus on the short-to-medium-term aspects where the most immediate, actionable impact can be achieved. The focus on improving procedural efficiency and optimizing the patient pathway via clinical practice and patient management demonstrates how to mitigate the current major issues of shortfall in catheterization laboratory, workforce, and bed capacity. Procedural efficiencies may be achieved through steps including streamlined patient assessment, the benchmarking of standards for minimalist procedures, standardized approaches around patient monitoring and conduction issues, and the implementation of nurse specialists and dedicated TAVI coordinators to manage organization, logistics, and early mobilization. Increased collaboration with wider stakeholders within institutions will support successful TAVI uptake and improve patient and economic outcomes. Further, increased education, collaboration, and partnership between cardiology centers will facilitate sharing of expertise and best clinical practice.

Safety and efficacy of 48 mm Xience Xpedition everolimus-eluting stent for the treatment of long coronary lesions.

INTRODUCTION: Long drug-eluting stents may limit the issue of overlapping multiple stents when treating long coronary lesions. AIM: The aim of the study was to assess the safety and efficacy of the 48 mm Xience Xpedition everolimus-eluting stent (48mm-EES) for the treatment of long coronary lesions, in an all-comer population. METHODS: Patients receiving at least one 48mm-EES were prospectively included from March 2014 to December 2018. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 1 year. The main secondary endpoint was the patient-oriented composite endpoint (POCE) defined as a composite of death, stroke, myocardial infarction, and reintervention. RESULTS: A total of 268 patients with 276 long coronary lesions, including 94 chronic total occlusions (CTO), were successfully treated using at least one 48mm-EES. The total stent length per lesion was 66 ± 22 mm. A single 48mm-EES was suitable to successfully treat the target lesion in 48% of cases (60% for non-CTO lesions). One-year follow-up rate was 96.3%. TLF occurred in 13 patients (5.3%), mainly driven by TLR (4.1%). Two cardiac death occurred (0.7%). POCE occurred in 30 patients (11.6%) mainly driven by repeat revascularization (9.7%). Definite stent thrombosis was observed in two patients (0.7%). No difference was observed in one-year outcomes between single 48mm-EES and multiple stents implantation as well as between CTO and non-CTO lesions. CONCLUSION: The 48mm-EES is safe and effective to treat long coronary lesions, including CTOs, and provides attractive cost-effectiveness by limiting multiple stenting.

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry.

OBJECTIVES: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS). BACKGROUND: CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP. METHODS: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST). RESULTS: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. CONCLUSIONS: The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Acute ischemic stroke treated with mechanical thrombectomy and fungal endocarditis: A case report and systematic review of the literature.

Fungal endocarditis is a rare clinical form of infective endocarditis. The main etiology of FE is Candida albicans but also Candida parapsilosis and the overall mortality is high. We report a case of an acute ischemic stroke treated by mechanical thrombectomy, with the histopathological analysis of the retrieved clot followed by the confirmation of fungal endocarditis. An extensive review of the literature has been proposed and three key points concerning the fungal endocarditis predisposing factors, the relation between thrombolysis and hemorrhagic risk and, finally, the importance of clot analysis have been discussed.

Implementation of the transradial approach as an alternative vascular access for transcatheter aortic valve replacement guidance: Experience from a high-volume center.

OBJECTIVE: This study sought to assess the potential benefits of the transradial approach (TRA) as an alternative vascular access to the classical contralateral femoral approach for transcatheter aortic valve replacement (TAVR). BACKGROUND: Vascular and bleeding complications in TAVR have gradually decreased owing to operator experience and downsizing of the delivery system. However, about 1/4 of vascular access site complications are related to the transfemoral (TF) secondary access. METHODS: We compared the outcomes at 30 days according to VARC-2 after TAVR of a prospective cohort of 217 consecutive patients undergoing right or left TRA as the second vascular access (TRA-TF TAVR) and a retrospective cohort of 194 consecutive patients undergoing TF approach as a second vascular access (TF-TF TAVR). RESULTS: Baseline clinical characteristics and risk scores were well matched in both groups. Procedural success rate was 99.7%. Fluoro time was significantly lower in the TF-TF TAVR group (16.9 ± 7.2 vs. 19.1 ± 7.8 min, P = 0.003); however, there was no significant difference in x-ray exposure, procedure time or amount of contrast used. In the TRA-TF TAVR group, there were no complications related to the TRA access and there were less vascular and bleeding complications (18.0% vs. 9.7%, P = 0.014; 17.0% vs. 9.2%, P = 0.026, respectively), although blood transfusion requirement or hospitalization duration stay were similar in both groups. CONCLUSIONS: TRA approach as alternative secondary vascular access in TAVR is safe and feasible and is associated with a significant decrease in vascular and bleeding complications. Further, large-scale studies are warranted to confirm the potential benefit of this approach.

Identifying Patients at Risk for Prehospital Sudden Cardiac Arrest at the Early Phase of Myocardial Infarction: The e-MUST Study (Evaluation en Médecine d'Urgence des Stratégies Thérapeutiques des infarctus du myocarde).

BACKGROUND: In-hospital mortality of ST-segment-elevation myocardial infarction (STEMI) has decreased drastically. In contrast, prehospital mortality from sudden cardiac arrest (SCA) remains high and difficult to reduce. Identification of the patients with STEMI at higher risk for prehospital SCA could facilitate rapid triage and intervention in the field. METHODS: Using a prospective, population-based study evaluating all patients with STEMI managed by emergency medical services in the greater Paris area (11.7 million inhabitants) between 2006 and 2010, we identified characteristics associated with an increased risk of prehospital SCA and used these variables to build an SCA prediction score, which we validated internally and externally. RESULTS: In the overall STEMI population (n=8112; median age, 60 years; 78% male), SCA occurred in 452 patients (5.6%). In multivariate analysis, younger age, absence of obesity, absence of diabetes mellitus, shortness of breath, and a short delay between pain onset and call to emergency medical services were the main predictors of SCA. A score built from these variables predicted SCA, with the risk increasing 2-fold in patients with a score between 10 and 19, 4-fold in those with a score between 20 and 29, and >18-fold in patients with a score ≥30 compared with those with scores <10. The SCA rate was 28.9% in patients with a score ≥30 compared with 1.6% in patients with a score ≤9 (P for trend <0.001). The area under the curve values were 0.7033 in the internal validation sample and 0.6031 in the external validation sample. Sensitivity and specificity varied between 96.9% and 10.5% for scores ≥10 and between 18.0% and 97.6% for scores ≥30, with scores between 20 and 29 achieving the best sensitivity and specificity (65.4% and 62.6%, respectively). CONCLUSIONS: At the early phase of STEMI, the risk of prehospital SCA can be determined through a simple score of 5 routinely assessed predictors. This score might help optimize the dispatching and management of patients with STEMI by emergency medical services.

Incidence and predictors of coronary obstruction following transcatheter aortic valve implantation in the real world.

OBJECTIVES: Coronary obstruction (CO) is a rare but serious complication of transcatheter aortic valve implantation (TAVI). There are very limited data regarding CO following TAVI. The aim of this study was to evaluate the incidence and outcomes of CO after TAVI and identify the predictors including the valve type. METHODS: Between October 2006 and March 2015, 1,203 TAVI cases were performed in our institution. Of them, 814 cases whose coronary height was measured using computed tomography for screening were analyzed in this study. RESULTS: The Edwards SAPIEN/SAPIEN XT (S/XT) was used in 427 (52.4%) cases, the CoreValve in 265 (32.6%), and the S3 in 122 (15.0%). CO occurred in 8 (1.0%) cases, 1.6% with S/XT, 0.4% with CoreValve, and 0% with S3. All instances of CO occurred at the left coronary artery. The 30-day mortality was significantly higher in cases of CO (37.5% vs. 5.8%, P = 0.010). The frequency of CO tended to be lower in recipients of the CoreValve (0.4%) and S3 (0%) compared with the S/XT (1.6%) (P = 0.188 for CoreValve vs. S/XT, P = 0.022 for S3 vs. S/XT). CONCLUSIONS: CO has poor outcomes and identification of patients at risk of CO to take preventive measures is crucial. The preliminary data showing that the occurrence of CO is low in patients receiving the S3 despite increased prosthesis height need further confirmation. © 2017 Wiley Periodicals, Inc.

Registry on acute cardiovascular events during endurance running races: the prospective RACE Paris registry.

AIM: Long distance running races are associated with a low risk of life-threatening events much often attributed to hypertrophic cardiomyopathy. However, retrospective analyses of aetiology lack consistency. METHODS AND RESULTS: Incidence and aetiology of life-threatening/fatal events were assessed in long distance races in the prospective Registre des Accidents Cardiaques lors des courses d'Endurance (RACE Paris Registry) from October 2006 to September 2012. Characteristics of life-threatening/fatal events were analysed by interviewing survivors and reviewing medical records including post-mortem data of each case. Seventeen life-threatening events were identified of 511 880 runners of which two were fatal. The vast majority were cardiovascular events (13/17) occurring in experienced male runners [mean (±SD) age 43 ± 10 years], with infrequent cardiovascular risk factors, atypical warning symptoms prior to the race or negative treadmill test when performed. Acute myocardial ischaemia was the predominant aetiology (8 of 13) and led to immediate myocardial revascularization. All cases with initial shockable rhythm survived. There was no difference in event rate according to marathons vs. half-marathons and events were clustered at the end of the race. A meta-analysis of all available studies including the RACE Paris registry (n = 6) demonstrated a low prevalence of life-threatening events (0.75/100 000) and that presentation with non-shockable rhythm [OR = 29.9; 95% CI (4.0-222.5), P = 0.001] or non-ischaemic aetiology [OR = 6.4; 95% CI (1.4-28.8), P = 0.015] were associated with case-fatality. CONCLUSION: Life-threatening/fatal events during long distance races are rare, most often unpredictable and mainly due to acute myocardial ischaemia. Presentation with non-shockable rhythm and non-ischaemic aetiology are the major determinant of case fatality.

Comparison of Transradial vs Transfemoral Access for Aortoiliac and Femoropopliteal Interventions: A Single-Center Experience.

PURPOSE: To compare the procedure and safety outcomes of the transradial approach (TRA) with the femoral approach (FA) for treating aortoiliac and femoropopliteal stenoses and occlusions. METHODS: A single-center retrospective study was conducted involving 188 patients (mean age 66.4±10.8 years; 116 men) with lower limb claudication or critical limb ischemia who underwent aortoiliac (131, 62.4%) or femoropopliteal (79, 37.6%) interventions on 210 lesions over a 3-year period. Operator discretion determined TRA suitability; exclusions included Raynaud's disease, upper limb occlusive disease, previous TRA difficulties, or planned hemodialysis. Lesion characteristics, clinical endpoints, and access site complications were compared. RESULTS: FA was used primarily in 123 patients and the TRA (12 left and 53 right radial arteries) in 65 procedures. Eleven (16.9%) TRAs failed vs 9 (7.3%) FAs (p=0.42). Crossover to FA was due to occlusive lesions requiring alternative equipment in 9 cases and to tortuosity of the aortic arch vessels in 2 patients. The 134 FA interventions (balloon angioplasty, stents) were retrograde (112, 83.6%) or antegrade (22, 16.4%). There were significantly more TASC C/D lesions in the FA group (p=0.02). Sheath sizes (5-F to 8-F) did not differ between groups, and no significant differences were found between FA vs TRA in terms of procedure time (50.0±28.9 vs 46.8±25.1 minutes, p=0.50) or length of stay (2.2±0.6 vs 2.1±0.3 days, p=0.24). While there were no strokes, access site complications occurred in 6.0% of the FA patients vs 3.7% of the TRA patients (p=0.12). CONCLUSION: The transradial approach for aortoiliac and femoropopliteal interventions is safe and efficacious compared with the transfemoral approach for a range of lesion subtypes. Nevertheless, there remains a need for improvements in peripheral device and catheter technology to decrease transradial failure rates.

Feasibility and safety of transradial coronary interventions using a 6.5-F sheathless guiding catheter in patients with small radial arteries.

OBJECTIVES: This study investigated the feasibility and the safety of using a 6.5-French sheathless guide catheter in patients with small radial arteries. BACKGROUND: The small size of radial arteries is a limitation of transradial coronary intervention. A new sheathless guiding catheter with a diameter almost 2-Fr smaller than conventional sheaths and a full-length hydrophilic coating has been introduced. METHODS: A total of 148 patients from three French hospitals were consecutively enrolled from March 2009 to February 2012. They underwent transradial approach (TRA) for percutaneous coronary interventions (PCI) using the 6.5-F ASAHI sheathless Eaucath guiding catheter system. RESULTS: Among the 148 patients enrolled, 95 were females (64%), and 183 lesions were treated. Procedural success rate was 100%. Thirteen patients (9%) underwent same-procedure multivessel interventions for the right and left coronary artery. Among the group of 46 patients undergoing bifurcation PCI, 35 (76%) bifurcated lesions were treated with a kissing balloon technique, one patient had a saphenous vein bypass graft lesion requiring filter wire placement prior to intervention, nine (6.1%) patients required rotational atherectomy, thrombus-aspiration catheters were used in 19 (12.8%) patients, fractional flow reserve (FFR)-guided PCI in 10 (6.7%) patients, alcohol septal ablation in three (2%) patients. Ten (6.7%) cases of chronic total occlusion were successfully treated in nine (6.1%) patients using the hydrophilic catheter. No radial artery site complications was noted. CONCLUSION: The use of sheathless guiding catheters is a safe, effective method for PCI via TRA in small radial arteries without catheter-related complications.

Long-term outcome in early survivors of cardiogenic shock at the acute stage of myocardial infarction: a landmark analysis from the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Registry.

INTRODUCTION: There are little data about patients with cardiogenic shock (CS) who survive the early phase of acute myocardial infarction (AMI). The aim of this study was to assess long-term (5-year) mortality among early survivors of AMI, according to the presence of CS at the acute stage. METHODS: We analyzed 5-year follow-up data from the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2005 registry, a nationwide French survey including consecutive patients admitted for ST or non-ST-elevation AMI at the end of 2005 in 223 institutions. RESULTS: Of 3670 patients enrolled, shock occurred in 224 (6.1%), and 3411 survived beyond 30 days or hospital discharge, including 99 (2.9%) with shock. Early survivors with CS had a more severe clinical profile, more frequent concomitant in-hospital complications, and were less often managed invasively than those without CS. CONCLUSIONS: In patients surviving the early phase of AMI, CS at the initial stage carries an increased risk of death up to one year after the acute event. Beyond one year, however, mortality is similar to that of patients without shock. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT00673036, Registered May 5, 2008.

3D Stent Reconstruction Using CMCT: A Novel Method to Assess Stent Expansion.

Stent underexpansion in calcified coronary stenosis is an important predictor of major short- and long-term adverse cardiovascular events. In this case, we describe a novel method for assessing stent expansion using 3-dimensional stent reconstruction with C-arm motion compensated computed tomography.

Clinical effects of permanent pacemaker implantation after transcatheter aortic valve implantation: Insights from the nationwide FRANCE-TAVI registry.

BACKGROUND: The influence of permanent pacemaker implantation upon outcomes after transcatheter aortic valve implantation (TAVI) remains controversial. AIMS: To evaluate the impact of permanent pacemaker implantation after TAVI on short- and long-term mortality, and on the risk of hospitalization for heart failure. METHODS: Data from the large FRANCE-TAVI registry, linked to the French national health single-payer claims database, were analysed to compare 30-day and long-term mortality rates and hospitalization for heart failure rates among patients with versus without permanent pacemaker implantation after TAVI. Multivariable regressions were performed to adjust for confounders. RESULTS: A total of 36,549 patients (mean age 82.6years; 51.6% female) who underwent TAVI from 2013 to 2019 were included in the present analysis. Among them, 6999 (19.1%) received permanent pacemaker implantation during the index hospitalization, whereas 232 (0.6%) underwent permanent pacemaker implantation between hospital discharge and 30days after TAVI, at a median of 11 (interquartile range: 7-18) days. In-hospital permanent pacemaker implantation was not associated with an increased risk of death between discharge and 30days (adjusted odds ratio: 0.91, 95% confidence interval: 0.64-1.29). At 5years, the incidence of all-cause death was higher among patients with versus without permanent pacemaker implantation within 30days of the procedure (adjusted hazard ratio: 1.13, 95% confidence interval: 1.07-1.19). Permanent pacemaker implantation within 30days of TAVI was also associated with a higher 5-year rate of hospitalization for heart failure (adjusted subhazard ratio: 1.17, 95% confidence interval: 1.11-1.23). CONCLUSIONS: Permanent pacemaker implantation after TAVI is associated with an increased risk of long-term hospitalization for heart failure and all-cause mortality. Further research to mitigate the risk of postprocedural permanent pacemaker implantation is needed as TAVI indications expand to lower-risk patients.

Provisional side branch-stenting for coronary bifurcation lesions: evidence of improving procedural and clinical outcomes with contemporary techniques.

OBJECTIVES: To determine whether recent technical modifications have improved clinical outcomes for patients undergoing contemporary bifurcation lesion percutaneous coronary intervention (PCI). BACKGROUND: Provisional side branch (SB)-stenting has become the preferred strategy for bifurcation PCI. Newer generation drug-eluting stents (DESs), the proximal optimization technique (POT), and the use of noncompliant (NC) balloons for final kissing inflation (FKI) have the potential to optimize outcomes. METHOD: We compared baseline characteristics, procedural and clinical outcomes in 300 consecutive patient pairs treated in 2005 and 2009. The primary outcome measure was the cumulative incidence of major adverse cardiac events (MACE) at 2-years. RESULTS: Compared to 2005, patients undergoing PCI in 2009 were at higher risk: prior myocardial infarction (18% vs. 8%, P = 0.0004), left ventricular function (EF 54 ± 13% vs. 61 ± 12%, P < 0.0001). Cypher (53 vs. 3%, P < 0.001) and Taxus (47 vs. 11%, P < 0.0001) stents were used more frequently in 2005, and Xience V in 2009 (0 vs. 47%, P < 0.0001). In 2009, the POT was performed in 36% and NC balloons used for FKI in 81%. SB stenting was required less frequently in 2009 (9% vs. 22%, P < 0.001). Two-year MACE was significantly lower in 2009 than 2005 (5.7 vs. 11.3%, P = 0.02), a difference driven by fewer cardiac deaths (2.0 vs. 5.0%, P = 0.05). MACE was independently associated with left main bifurcation treatment [hazard ratio (HR) 1.85:95%, CI 1.04-3.29; P = 0.036], side-branch stenting (HR 2.31:95% CI 1.27-4.20; P = 0.006), and PCI in 2005 (HR 1.86:95% CI 1.03-3.37; P = 0.004). CONCLUSIONS: Together, contemporary techniques and newer generation DES appear to improve outcomes and are both recommended for widespread uptake in patients undergoing provisional SB stenting for coronary bifurcation lesions.

[Registry CARDIO-ARSIF - Database on coronary angiography and percutaneous coronary invasive performed in Île-de-France]. / Registre CARDIO-ARSIF - Base de données sur les coronarographies et angioplasties coronaires réalisées en Île-de-France.

The CARDIO-ARSIF registry has been continuously collecting comprehensive data on coronary angiography and percutaneous coronary interventions (PCI) performed in the 36 catheterization laboratories across the Île-de-France region since 2000. Over the period from 2003 to 2022, this registry has recorded information from more than 330,000 patients, encompassing more than one million procedures. Among these procedures, 58% consisted of coronary angiography, 13% were percutaneous coronary interventions (PCI), and the remaining 28% were PCI performed on an ad-hoc basis. This extensive dataset serves as a valuable resource for both qualitative and quantitative assessments of practices and the relevance of procedures in the field of coronary invasive cardiology. The results of these analyses undergo annual validation by a dedicated scientific committee and are shared with the teams of investigators. The exploitation of this data has led to scientific publications, with one notable finding being a consistent reduction in the radiation doses received by patients, regardless of the type of procedure.

Computed Tomography/Fluoroscopy Fusion and 3D Transesophageal Echocardiography-Guided Percutaneous Paravalvular Leak Closure.

Percutaneous paravalvular leak closure seems a safe alternative to surgery in frail patients. However, it is a challenging procedure that should be tailored to each patient with optimal imaging guidance. Transesophageal echocardiography during the procedure and computed tomography scan/fluoroscopy fusion provide guidance for critical steps, such as PVL localization and crossing. (Level of Difficulty: Advanced.).

A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary interventions (PCI) may require cardiac pacing during device delivery, generally requiring the insertion of a temporary pacing lead via an additional venous access site. The purpose-built Electroducer Sleeve device provides direct wire pacing without the need for a temporary venous pacemaker. AIMS: This study assessed the safety of temporary cardiac pacing using the novel sleeve device during PCI. METHODS: This was a multicentre, non-randomised, prospective, first-in-human, single-arm, pilot study. The primary endpoint was analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of effectiveness and qualitative outcomes. RESULTS: Sixty patients (mean age: 77.9±9.6 years) from 4 centres in France were included: 39 (65%) underwent TAVI, and 21 (35%) underwent PCI. Procedures were performed using the sleeve with access through the radial (32 patients; 53.3%) or femoral arteries (26; 43.3%), or the femoral vein (2; 3.3%). Primary endpoint analysis revealed that 2 patients (3.3%) developed EArly Discharge After Transradial Stenting of CoronarY Arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%). Analyses of other secondary endpoints showed that 2 patients (6.3%) presented asymptomatic radial artery occlusion. No allergies were reported. CONCLUSIONS: This first-in-human trial using the Electroducer Sleeve indicated that this novel, purpose-built, temporary pacing device was safe and effective. Larger prospective studies are required to confirm these findings.

Prevalence, Management and Outcomes of Percutaneous Coronary Intervention for Coronary In-Stent Restenosis: Insights From the France PCI Registry.

BACKGROUND: Despite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical management of ISR is lacking. METHODS: The aim was to describe the epidemiology and management of patients with ≥1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry. RESULTS: Between January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64-3.06]; p < 0.001). CONCLUSIONS: In a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI.