Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study.

BACKGROUND: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. AIMS: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. METHODS: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. RESULTS: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001). CONCLUSIONS: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

The Utility of the SYNTAX Score II and SYNTAX Score 2020 for Identifying Patients with Three-Vessel Disease Eligible for Percutaneous Coronary Intervention in the Multivessel TALENT Trial: A Prospective Pilot Experience.

Background: Personalized prognosis plays a vital role in deciding between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD). The aim of this study is to compare the modality of revascularization chosen by the local heart team to that recommended by using individualized predictions of medium, and long-term all-cause mortality amongst patients with 3VD screened in the Multivessel TALENT trial. Methods: The SYNTAX score II (SS-II) and SS-2020 were evaluated in 200 consecutive patients by a core laboratory and compared to the decision of the "on site" heart team. Results: According to the SS-II, CABG was the recommended treatment in 51 patients (25.5%) however 34 (66.6%) of them received PCI. According to SS-2020 the predicted absolute risk differences (ARD) between PCI and CABG were significantly higher in patients receiving CABG compared to those treated by PCI for major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, stroke or myocardial infarction at 5-years (8.8 ± 4.6% vs 6.0 ± 4.0%, p < 0.001) and all-cause mortality at 5- (5.2 ± 3.5% vs 3.7 ± 3.0%, p = 0.008) and 10-years (9.3 ± 4.8% vs 6.2 ± 4.2%, p < 0.001). Based on the novel threshold of equipoise (individual absolute risk differences [ARD] < 4.5%), 133 patients were eligible for PCI however 23 of them underwent CABG; conversely, amongst the 67 patients where CABG was recommendation (individual ARD > 4.5%), only 19 received it. Conclusions: Despite the robustness of the risk models proposed for screening, several deviations from the recommended mode of revascularization were observed by the core laboratory among the first 200 patients with 3VD screened in the Multivessel TALENT trial. Clinical Trial Registration: ClinicalTrials.gov reference: NCT04390672.

Assessment of chronical total occlusions management in France: The ENCOCHE Registry, a prospective, multicentric study.

BACKGROUND: Coronary chronic total occlusions (CTO) are frequent, and coronary angioplasty has been increasingly used in recent years for lesion revascularisation. However, to date, no dedicated multicentric prospective study is available in France. AIM: To describe the characteristics of CTO patients and to assess current treatment strategies in French catheterisation laboratory practice. METHODS: Patients presenting with CTOs were included from 16/09/2021 to 13/12/2021 over two consecutive prospective phases. In phase I (one month), data were collected to include all patients presenting CTO at diagnostic angiography. In phase II (two months), data were collected focusing on patients who underwent CTO-PCI. RESULTS: A total of 1303 patients (1460 CTOs) were included in 68 French centres. The mean age was 67.7±10.7 years and 84.3% of the patients were men. The prevalence of prior PCI (44.6%), and diabetes mellitus (35.6%) was high. In phase I, multivessel coronary artery disease was detected in two-thirds of cases, and most of them (88.5%) had a single CTO. The mean J-CTO score was 1.9±1.2, with a proportion of difficult and very difficult CTO (J CTO score ≥2) of 61.1%. The selected treatment was medical therapy in 57% of cases, coronary angioplasty in 30% and bypass surgery in 13%. In phase II, 528 patients were included with a mean J-CTO score of 1.8±1.2. Successful guidewire crossing through CTO lesion was obtained with an antegrade access in 89% of patients. Procedural success rate of CTO-PCI was 80%, with a rate of major in-hospital complications of 1% (death: 0.4%, MI: 0.2%, stroke: 0.2%, emergency CABG: 0.2%). CONCLUSION: This prospective study provides a snapshot of CTOs prevalence and CTO treatment strategies in France in 2021.

OPTImized coronary interventions eXplaIn the bEst cliNical outcomEs (OPTI-XIENCE) study. Rationale and study design.

INTRODUCTION: Clinical events may occur after percutaneous coronary intervention (PCI), particularly in complex lesions and complex patients. The optimization of PCI result, using pressure guidewire and intracoronary imaging techniques, may reduce the risk of these events. The hypothesis of the present study is that the clinical outcome of patients with indication of PCI and coronary stent implantation that are at high risk of events can be improved with an unrestricted use of intracoronary tools that allow PCI optimization. METHODS AND ANALYSIS: Observational prospective multicenter international study, with a follow-up of 12 months, including 1064 patients treated with a cobalt­chromium everolimus-eluting stent. Inclusion criteria include any of the following: Lesion length > 28 mm; Reference vessel diameter < 2.5 mm or > 4.25 mm; Chronic total occlusion; Bifurcation with side branch ≥2.0 mm;Ostial lesion; Left main lesion; In-stent restenosis; >2 lesions stented in the same vessel; Treatment of >2 vessels; Acute myocardial infarction; Renal insufficiency; Left ventricular ejection fraction <30 %; Staged procedure. The control group will be comprised by a similar number of matched patients included in the "extended risk" cohort of the XIENCE V USA study. The primary endpoint will be the 1-year rate of target lesion failure (TLF) (composite of ischemia-driven TLR, myocardial infarction (MI) related to the target vessel, or cardiac death related to the target vessel). Secondary endpoints will include overall mortality, cardiovascular mortality, acute myocardial infarction, TVR, TLR, target vessel failure, and definitive or probable stent thrombosis at 1 year. IMPLICATIONS: The ongoing OPTI-XIENCE study will contribute to the growing evidence supporting the use of intra-coronary imaging techniques for stent optimization in patients with complex coronary lesions.

Frequency of periprocedural myocardial injury and infarction stratified by cardiac troponin I and cardiac troponin T.

BACKGROUND: There are different definitions of periprocedural myocardial infarction (PPMI) both in terms of thresholds for cardiac biomarkers and the ancillary criteria for myocardial ischemia. Cardiac Troponin I (cTnI) and cardiac Troponin T (cTnT) are used interchangeably to diagnose PPMI. OBJECTIVES: This study evaluated the frequency of periprocedural myocardial injury and infarction as defined by the Society of Cardiovascular Angiography & Interventions (SCAI), the Academic Research Consortium-2 (ARC-2), and the 4th Universal definition of MI (4UDMI) stratified using cTnT versus cTnI, among patients with chronic coronary syndrome (CCS) and unstable angina. RESULTS: Among 830 patients, PPMI rates according to the SCAI, ARC2 and 4UDMI criteria were 4.34 %, 2.05 %, and 4.94 % respectively, with higher rates seen for all definitions when using cTnI versus cTnT (SCAI: 9.84 % vs. 1.91 %, p < 0.001; ARC 2: 3.15 % vs. 1.56 %, p = 0.136; and 4UDMI 5.91 % vs. 4.51 %, p = 0.391). Minor and major periprocedural myocardial injury was respectively observed in 58.31 % and 27.10 % of patients, with rates of both significantly higher when using cTnI versus cTnT (Minor: 69.29 % vs. 53.47 %, p < 0.001, Major: 49.21 % vs. 17.36 %, p < 0.001). CONCLUSIONS: Among patients with CCS and unstable angina, PPMIs defined by SCAI occurred more frequently when using cTnI as opposed to cTnT, whereas the type of troponin had no impact on the incidence of PPMIs according to the ARC-2 and 4UDMI.

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.

Minimizing the risk of contrast-induced nephropathy and hemodynamic collapse during chronic total occlusion percutaneous coronary intervention with a percutaneous left ventricular assist device.

Candidates for percutaneous coronary revascularization are becoming progressively older and more complex. A combination of factors related to the patient, lesion, and/or hemodynamic conditions may increase the risk of adverse events. Therefore, when a high-risk procedure is identified, it is crucial to provide the patient with adequate support in order to safely perform percutaneous coronary intervention (PCI). We report the case of a 77-year-old man with moderate left ventricular dysfunction and stage IV chronic kidney disease who underwent successful recanalization of a chronically occluded left anterior descending artery. The procedure was performed with a micro-axial percutaneous left ventricular assist device (Impella 2.5) in order to provide stable hemodynamics, and with minimal contrast medium administration (14 ml) to minimize the risk of acute kidney injury. Despite the use of aggressive techniques (including rotational atherectomy), the patients remained stable throughout the procedure and did not experience contrast-induced nephropathy or periprocedural myocardial infarction, and was discharged two days later. Moreover, we provide recommendations to assist interventional cardiologist safely perform complex and high-risk PCI, with particular attention to renal function preservation.

Femoral pseudoaneurysms and current cardiac catheterization: evaluation of risk factors and treatment.

OBJECTIVES: We sought to determine the incidence of femoral pseudoaneurysm (FPA) following cardiac catheterization, identify the risk factors for FPA and factors influencing therapeutic strategy. METHODS: 11,992 consecutive patients who underwent cardiac catheterization via femoral artery were studied over a period of four years in one University Hospital. Our prospective case control group analysis registered patients who developed FPA after the procedure. Patient-related factors, procedure related factors and peri-procedure treatment were compared between the two groups. RESULTS: 76 FPA were diagnosed over the study period accounting for a global incidence of 0.6% procedures. By univariate analysis, interventional procedure (p<0.01), rhythmologic procedure (p=0.03), sheath>or=6F (p=0.04) and left groin puncture (p<0.001) were FPA risk factors. By multivariate analysis, interventional procedure (adjusted odds ratio [OR]=1.99; 95% confidence interval [CI]1.14-3.44 p=0.01) and left groin puncture (OR=4.65; 95% CI, 1.78-12.1 p=0.001) are independent predictive factors of FPA. FPA thrombosis was obtained by ultrasound guided compression (UGC) in 71% of the cases. By univariate analysis, PFA diameter larger than 4 cm (p<0.001), the use of anticoagulation (p<0.01) or GPIIbIIIa inhibitors (p=0.001) and UGC under anticoagulation (p=0.01) are predictive factors of need for FPA surgical repair. By multivariate analysis, FPA diameter>4 cm and use of GPIIbIIIa inhibitors are independent predictive factors of FPA's surgical treatment. Superficial femoral puncture was predictive of successful UGC both by uni and multivariate analysis. CONCLUSIONS: Our study shows that FPA occurrence is mainly due to by procedure-related factors. FPA size, level of puncture and the use of GPIIbIIIa inhibitors are independent predictive factors of need for surgical therapy.

Effects of ventricular resynchronization in previously paced patients developing refractory heart failure.

Biventricular resynchronization has been shown to be beneficial on morbidity and mortality in patients with symptomatic (NYHA class III or IV) systolic heart failure (left ventricular ejection fraction or LVEF is less or equal to 35%) under optimal medical treatment with electrical asynchrony (QRS > or = 120 ms) and in sinus rhythm. The purpose of this study was to evaluate the efficacy and safety of upgrading to biventricular resynchronization in paced patients presenting with symptomatic systolic heart failure. Over a period of eight years, 24 paced patients with symptomatic (class III or IV) systolic heart failure (LVEF < or =35%) with electrical asynchrony (QRS > or =160 ms) received an additional left ventricular pacing lead and a biventricular pulse generator. We compared the functional symptoms, QRS duration, LVEF, left ventricle telediastolic diameter and any aggravation or onset of ventricular arrhythmia before and after biventricular resynchronization. Biventricular resynchronization led to an improvement in dyspnea in 80% of cases (one or more class decrease on NHYA scale), a significant shortening in QRS duration (-40 ms, p < 0.05), a significant improvement in left ventricular dilation (-4 mm, p < 0.05) and a significant improvement in the ejection fraction (+4%, p < 0.05). This study showed that in paced patients presenting with cardiac failure and systolic dysfunction refractory to medical treatment, upgrading from a conventional pacing system to a biventricular pacemaker leads to a significant improvement in functional symptoms.