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.

Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study.

BACKGROUND: New-onset left bundle branch block (LBBB) is one of the most frequent complications after transcatheter aortic valve implantation (TAVI) and is associated with delayed high degree atrioventricular (AV) block. OBJECTIVES: The objectives of this study were to determine the incidence of AV block in such a population and to assess the performance and safety of a risk stratification algorithm on the basis of electrophysiology study (EPS) followed by implantation of a pacemaker or implantable loop recorder (ILR). METHODS: This was a prospective open-label study with 12-month follow-up. From June 8, 2015, to November 8, 2018, 183 TAVI recipients (mean age 82.3 ± 5.9 years) were included at 10 centers. New-onset LBBB after TAVI persisting for >24 hours was assessed by electrophysiology study during initial hospitalization. High-risk patients (His-ventricle interval ≥70 ms) were implanted with a dual-chamber pacemaker recording AV conduction disturbance episodes. Patients at lower risk were implanted with an ILR with automatic remote monitoring. RESULTS: A high-grade AV conduction disorder was identified in 56 patients (30.6%) at 12 months. Four subjects were symptomatic, all in the ILR group. No complications were associated with the stratification procedure. Patients with His-ventricle interval ≥70 ms displayed more high-grade AV conduction disorders (53.2% [25 of 47] vs 22.8% [31 of 136]; P < .001). In a multivariate analysis, His-ventricle interval ≥70 ms was independently associated with the occurrence of a high-grade conduction disorder (subdistribution hazard ratio 2.4; 95% confidence interval 1.2-4.8; P = .010). CONCLUSION: New-onset LBBB after TAVI was associated with high rates of high-grade AV conduction disturbances. The stratification algorithm provided safe and valuable aid to management decisions and reliable guidance on pacemaker implantation.

Post-stEnting assessment of Re-endothelialization with optical Frequency domain imaging aftEr Chronic Total Occlusion procedure: The PERFE-CTO Study Design and Rationale.

BACKGROUND: The treatment of chronic total occlusion of coronary arteries by percutaneous coronary intervention (CTO PCI) is one of the most representative technical advances in ischemic cardiomyopathy of last decade. However, how the complex histopathological remodeling and the new techniques affect healing processes after stent implantation remains unknown. OBJECTIVE: The objective of the PERFE-CTO study is to analyze stent coverage, malapposition and other mechanical abnormalities 3 months after CTO recanalization using intravascular imaging. METHODS: In a French prospective interventional multicenter study, stent strut coverage, acquired malapposition and neointimal hyperplasia (NIH) proliferation will be systematically assessed with 3 months angiogram control and intracoronary optical frequency domain imaging (OFDI) after successful CTO PCI of >20 mm in length. The impact of routine systematical intracoronary imaging after these complex procedures will also be evaluated by measuring the rate of significant mechanical abnormalities (strut malapposition, edge dissection, thrombus) that was undetected by fluoroscopy alone and by complementary PCI when needed. Secondarily, these data will be compared according to clinical characteristics, antiplatelet therapy use or desobstruction technique (antegrade vs. retrograde, true lumen vs. subintima). Each patient will undergo a one-year clinical follow-up. A total of 150 analyzed CTO lesions is expected. CONCLUSION: The PERFE-CTO study will provide essential understanding of the early history after CTO recanalization and the identification of inadequate evolution (stent thrombosis, restenosis or late delayed stent endothelization and cardiovascular outcomes) using intravascular imaging to improve long-term CTO results.

Automated peroperative assessment of stents apposition from OCT pullbacks.

This study's aim was to control the stents apposition by automatically analyzing endovascular optical coherence tomography (OCT) sequences. Lumen is detected using threshold, morphological and gradient operators to run a Dijkstra algorithm. Wrong detection tagged by the user and caused by bifurcation, struts'presence, thrombotic lesions or dissections can be corrected using a morphing algorithm. Struts are also segmented by computing symmetrical and morphological operators. Euclidian distance between detected struts and wall artery initializes a stent's complete distance map and missing data are interpolated with thin-plate spline functions. Rejection of detected outliers, regularization of parameters by generalized cross-validation and using the one-side cyclic property of the map also optimize accuracy. Several indices computed from the map provide quantitative values of malapposition. Algorithm was run on four in-vivo OCT sequences including different incomplete stent apposition's cases. Comparison with manual expert measurements validates the segmentation׳s accuracy and shows an almost perfect concordance of automated results.

Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial.

BACKGROUND: An aging population and better management of various heart diseases explain the exponential growth in incidence and prevalence of chronic heart failure, with poor prognosis and heavy health costs. Medical management is codified in international guidelines. The management of heart failure in over-80 year-old patients follows these guidelines, but no clinical trials have been able to confirm benefit. Moreover, registries show down-prescription of heart failure treatments in the elderly and over-80s. METHODS/DESIGN: We present the design of the HF-80 ("Is there benefit in optimising heart failure treatment in over-80 year-old patients?") study, which is a prospective randomised open-label clinical trial with blinded end-points, designed to evaluate the effect of optimising management by adhering to guidelines in over-80 year-old heart failure patients. Patients over 80 years of age admitted with acute heart failure will be included. The primary endpoint is to assess quality of life at 6 months on the Minnesota questionnaire. The secondary endpoints are to assess the effect of optimised management on quality of life, mortality, readmission for acute heart failure, cardiac fibrosis and economic data at 12 months. 80 patients will be included, divided into 2 groups: group A, with usual heart failure management by general practitioners; and group B, with optimised management based on international guidelines. DISCUSSION: It is necessary to assess the benefit of guidelines in over-80 year-old heart failure patients because of the fragility of this population and the elevated risk of iatrogenic complications. TRIAL REGISTRATION: Clinical trials.gov number: NCT01437371.

Primary angioplasty is cost-minimizing compared with pre-hospital thrombolysis for patients within 60 min of a percutaneous coronary intervention center: the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) cost-efficacy sub-study.

OBJECTIVES: This ancillary study of the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) trial sought to assess the cost-efficacy ratio of primary coronary angioplasty (PCA) and pre-hospital thrombolysis (PHT) in patients suffering from an acute myocardial infarction (AMI) (<6 h) close to (<60 min journey) a percutaneous coronary intervention (PCI) center. BACKGROUND: In the CAPTIM study, at 30 days follow-up PCA was as equally effective as PHT with rescue angioplasty if needed. The cost efficacy of these two strategies has not yet been compared. METHODS: Data were prospectively collected for 299 patients in three centers. The efficacy analysis was extended at one-year follow-up for those patients. Direct fixed and variable actual costs were assessed with a piggyback data collection. RESULTS: The one-year primary end point event-rate (death, non-fatal myocardial infarction, and stroke) was not different after PCA or PHT (14% vs. 16. 4%, p = NS). Costs were lower in the PCA group either during the in-hospital period (8,287 vs. 9,170 $, p = 0.0001) and after one-year follow-up, in relation to a higher rate of subsequent revascularizations in the PHT group (49% vs. 23%, p < 0. 01), leading to a longer hospital stay (10 vs. 9.1 days, p = 0. 03). CONCLUSIONS: After AMI in patients less than 1 h from a PCI center, PCA is as effective and less costly than a combined strategy of PHT followed by rescue angioplasty.