Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group.

Since the publication of the 2015 EAPCI consensus on rotational atherectomy, the number of percutaneous coronary interventions (PCI) performed in patients with severely calcified coronary artery disease has grown substantially. This has been prompted on one side by the clinical demand for the continuous increase in life expectancy, the sustained expansion of the primary PCI networks worldwide, and the routine performance of revascularization procedures in elderly patients; on the other side, the availability of new and dedicated technologies such as orbital atherectomy and intravascular lithotripsy, as well as the optimization of the rotational atherectomy system, has increased operators' confidence in attempting more challenging PCI. This current EAPCI clinical consensus statement prepared in collaboration with the EURO4C-PCR group describes the comprehensive management of patients with heavily calcified coronary stenoses, starting with how to use non-invasive and invasive imaging to assess calcium burden and inform procedural planning. Objective and practical guidance is provided on the selection of the optimal interventional tool and technique based on the specific calcium morphology and anatomic location. Finally, the specific clinical implications of treating these patients are considered, including the prevention and management of complications and the importance of adequate training and education.

Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry.

OBJECTIVES: The aim of this study was to determine the 3-year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation. BACKGROUND: Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1-year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long-term follow-up of patients treated with BVS are scarce. METHODS: All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3-year scaffold thrombosis and target vessel revascularization (TVR). RESULTS: Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3-year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS. CONCLUSIONS: Although 3-year mortality was low in this ACS population, device-related events were significant beyond 1 year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long-term follow-up.

Management of left main disease: an update.

A severe narrowing of the left main coronary artery (LMCA), usually due to atherosclerosis, jeopardizes a large area of myocardium and increases the risk of major adverse cardiac events. Management strategies for LMCA disease include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). In general, PCI offers more rapid recovery and a lower early adverse event rate, whereas CABG offers a more durable procedure. The largest of six LMCA trials comparing PCI with CABG recently reported that in patients with site-reported low or intermediate anatomical complexity PCI was non-inferior to CABG with respect to the composite of death, stroke, or myocardial infarction at 3 years. This result was obtained on a background of contemporary PCI standards, including safer and more effective stents, intravascular imaging and physiology assessment. This review updates on the current management of LMCA disease, with an emphasis on clinical data and procedural knowledge supporting the use of PCI in a growing proportion of patients.

Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Live-case demonstrations: putting patients first.

Live-case demonstrations have become essential teaching tools. Debate about their added educational value and risk-benefit considerations vis-à-vis patient safety demand that major interventional cardiology meetings offering live-case demonstrations carefully define and monitor the objectives and quality of the cases included at their meetings. To this end, Europa Organisation, the content-providing group that supports EuroPCR and other PCR conferences internationally, has convened the PCR VITAL-Live Workshop, bringing together senior interventional cardiologists and experienced live-case operators with the aim of defining and reviewing the key components and goals of valuable live-case demonstrations. The Vital-Live participants unanimously agreed that live cases provide an educational experience with an immediacy and intensity that is unmatched by taped cases, through audience engagement with unfiltered reality and participation in real-time decision-making. Best practices regarding case selection, preparation, objectives, delivery, and discussion of the demonstrations were designed to ensure that the lessons learned would be clear and implementable by audience members, leading to improved patient care and safety in their own practices. Today's on-line accessibility of live-cases underscores the need for operators, hospitals, panels, and meeting chairs to insure that the content, quality, and intent anticipate any public scrutiny. This requires putting patient outcomes first, both at the level of the live demonstration itself and its broader educational worth.

Bioresorbable scaffolds for treatment of coronary bifurcation lesions: Critical appraisal and future perspectives.

Bioresorbable vascular scaffolds have been recently introduced as a novel paradigm for coronary artery disease treatment allowing temporary vessel support and drug delivery without indefinite coronary caging, potentially reducing the long-term limitation of metallic stents. The scientific community has rapidly embraced this concept and bioresorbable devices have been introduced in clinical practice. However, despite the fact that bifurcation lesions represent a large and challenging subset in the field of interventional cardiology, this subgroup of lesions have been avoided in the initial experience with bioresorbable scaffolds and clear recommendations on methodological approaches are lacking. In the present report, we describe the various techniques for bifurcation treatment with bioresorbable scaffolds and the theoretical advantages and disadvantages of this technology in different scenarios, with a glimpse to challenging subsets and possible complications. Therefore, we aim to provide experience based insights and practical guidance for bioresorbable scaffold implantation in bifurcation lesions. © 2016 Wiley Periodicals, Inc.

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

Five-year survival in patients with ST-segment-elevation myocardial infarction according to modalities of reperfusion therapy: the French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Cohort.

BACKGROUND: Although primary percutaneous coronary intervention (pPCI) is the preferred reperfusion method for ST-segment-elevation myocardial infarction, it remains difficult to implement in many areas, and fibrinolytic therapy is still widely used. METHODS AND RESULTS: We assessed 5-year mortality in patients with ST-segment-elevation myocardial infarction from the French Registry of Acute ST-Elevation or Non-ST Elevation Myocardial Infarction (FAST-MI) 2005 according to use and type of reperfusion therapy. Of 1492 patients with ST-segment-elevation myocardial infarction with a first call ≤12 hours from onset, 447 (30%) received fibrinolysis (66% prehospital; 97% with subsequent angiography, 84% with subsequent PCI), 583 (39%) had pPCI, and 462 (31%) received no reperfusion. Crude 5-year survival was 88% for the fibrinolytic-based strategy, 83% for pPCI, and 59% for no reperfusion. Adjusted hazard ratios for 5-year death were 0.73 (95% confidence interval, 0.50-1.06) for fibrinolysis versus pPCI, 0.57 (95% confidence interval, 0.36-0.88) for prehospital fibrinolysis versus pPCI, and 0.63 (95% confidence interval, 0.34-0.91) for fibrinolysis versus pPCI beyond 90 minutes of call in patients having called ≤180 minutes from onset. In propensity score-matched populations, however, survival rates were not significantly different for fibrinolysis and pPCI, both in the whole population (88% lysis, 85% pPCI) and in the population seen early (87% fibrinolysis, 85% pPCI beyond 90 minutes from call). CONCLUSIONS: In a real-world setting, on a nationwide scale, a pharmaco-invasive strategy constitutes a valid alternative to pPCI, with 5-year survival at least equivalent to that of the reference reperfusion method. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifier: NCT00673036.

Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 Registry.

BACKGROUND: Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. METHODS AND RESULTS: TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1-Q3=178-490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P=0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery (P=0.04), larger aortic annulus (P=0.0004), and smaller prosthesis diameter (P=0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery(P=0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P=0.0001) and SE-TAVR (hazard ratio=2.11; P=0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR

Registry of transcatheter aortic-valve implantation in high-risk patients.

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

Impact of pre- and post-procedural anemia on the incidence of acute kidney injury and 1-year mortality in patients undergoing transcatheter aortic valve implantation (from the French Aortic National CoreValve and Edwards 2 [FRANCE 2] Registry).

OBJECTIVES: The relationship between anemia, renal insufficiency, and the outcomes of TAVI patients has not been thoroughly studied. We aimed to evaluate the influence of pre- and post-procedural anemia on the incidence of renal insufficiency, especially AKI, and on the outcomes of TAVI. METHODS: Data from the French national TAVI registry were collected in 3,472 patients who underwent TAVI between January 2010 and December 2012. Of these 2,137 were in the no/mild anemia group, 748 were in the moderate anemia group, and 587 were in the severe anemia group before TAVI. Furthermore, we divided the 3,472 patients into three groups according to post-procedural anemia, measured as post-procedural hemoglobin (Hb) drop: <2 g/dl (n=1,633, group 1), 2 to <4 g/dl (n=1,458, group 2), and >4 g/dl (n = 381, group 3). Procedure and outcome variables were compared. RESULTS: Increased severity of anemia before TAVI was associated with significantly different rates of 1-year mortality (15%, 19%, and 24%, P<0.01), with similar differences in the incidence of AKI (5%, 8%, and 10%, P<0.01). Increased severity of Hb drop was associated with significantly different rates of 1-year mortality (16%, 18%, and 23%, P<0.01), and with similar differences in the incidence of AKI (6%, 7%, and 10%, P=0.04). Both pre- and post-procedural anemia were predictors of the incidence of AKI (OR 1.82, P<0.01; OR 1.82, P<0.01, respectively) and 1-year mortality (HR 1.44, P<0.01; HR 1.50, P<0.01, respectively). CONCLUSIONS: Both pre- and post-procedural anemia were significantly associated AKI and 1-year mortality.

Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011: current status in 37 ESC countries.

AIMS: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. METHODS AND RESULTS: A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. CONCLUSION: Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.

Randomized study to assess the effect of thrombus aspiration on flow area in patients with ST-elevation myocardial infarction: an optical frequency domain imaging study--TROFI trial.

AIMS: Primary percutaneous coronary intervention (PPCI) with thrombectomy (TB) seems to reduce the thrombus burden, resulting in a larger flow area as measured with optical frequency domain imaging (OFDI). METHODS AND RESULTS: In a multi-centre study, 141 patients with ST elevation myocardial infarction <12 h from onset were randomized to either PPCI with TB using an Eliminate catheter (TB: n = 71) or without TB (non-TB: n = 70), having operators blinded for the OFDI results. The primary endpoint was minimum flow area (MinFA) post-procedure assessed by OFDI, defined as: [stent area + incomplete stent apposition (ISA) area] - (intraluminal defect + tissue prolapse area). Sample size was based on the expected difference of 0.72 mm(2) in MinFA. Baseline demographics, pre-procedural quantitative coronary angiography (QCA), and procedural characteristics were well matched between the two groups. On OFDI, the stent area (TB: 7.62 ± 2.23 mm(2), non-TB: 7.05 ± 2.12 mm(2), P = 0.14) and MinFA (TB: 7.08 ± 2.14 mm(2) vs. non-TB: 6.51 ± 1.99 mm(2), Δ0.57 mm(2), P = 0.12) were not different. In addition, the amount of protrusion, intraluminal defect, and ISA area were similar in the both groups. CONCLUSION: PPCI with TB was associated with a similar flow area as well as stent area to PPCI without TB.

Prevalence, distribution, predictors, and outcomes of patients with calcified nodules in native coronary arteries: a 3-vessel intravascular ultrasound analysis from Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT).

BACKGROUND: Pathological studies suggest that calcified coronary nodules are a rare cause of thrombotic events. The frequency, distribution, predictors, and outcomes of calcified nodules have never been described. METHODS AND RESULTS: After successful stenting in 697 patients (167 female; median age, 58.1 years) with acute coronary syndromes, 3-vessel gray-scale and virtual histology intravascular ultrasound was performed in the proximal-mid segments of all 3 coronary arteries as part of a prospective, multicenter study. On the basis of recent histological validation, an independent core laboratory identified calcified nodules as distinct calcification with an irregular, protruding, and convex luminal surface. Patients were followed up for 3 years (median). Overall, 314 calcified nodules were detected in 250 of 1573 analyzable arteries (185 of 623 patients). Thus, the prevalence of calcified nodules was 17% per artery and 30% per patient. Two or more calcified nodules were detected in 48 coronary arteries (3%) in 76 patients (12%). The calcified nodules were located <40 mm from the ostium of the coronary artery in 85% of left anterior descending arteries and 86% of left circumflex arteries, whereas calcified nodules within the right coronary arteries were evenly and more distally distributed. Patients with calcified nodules were significantly older and had more plaque volume, more thick-cap fibroatheroma, but fewer nonculprit lesion major adverse events on follow-up. CONCLUSIONS: Calcified nodules in untreated nonculprit coronary segments in patients with acute coronary syndromes were more prevalent than previously recognized. Although their distribution mirrored the origin of most thrombotic events, calcified nodules caused fewer major adverse events during 3 years of follow-up.

Trends in outcome after transfemoral transcatheter aortic valve implantation.

BACKGROUND: Transfemoral transcatheter aortic valve implantation (TF-TAVI) is a viable and safe treatment strategy for patients with symptomatic severe aortic stenosis and high operative risk and has been introduced as such in the recently updated European guidelines on the management of valvular heart disease.Our aim was to assess trends in outcome after TF-TAVI. METHODS: Propensity score-matched analysis of a multicenter registry of consecutive patients undergoing TF-TAVI subdivided into 3 tertiles based on enrollment date was performed. Three tertiles of 214 propensity score-matched patients were compared. RESULTS: With mounting experience and moving from the initial to the last cohort, procedural contrast volume and radiation time decreased. Over time, there were less major vascular complications (15% vs 7.9%, P = .023), life-threatening bleedings (17.8% vs 7.9%, P = .003), and major bleedings (22.4% vs 12.1%, P = .007). Major vascular complications and life-threatening bleedings caused by closure device failure decreased significantly (9.2% vs 3.1% [P = .01] and 5.7% vs 1 % [P = .01], respectively). The combined safety end point dropped from 31.3% in tertile (T) (T1) to 17.8% in T3 (P < .001). By multivariable analysis, the last cohort as compared with the initial cohort was associated with significant reductions in 30-day mortality (odds ratio [OR] 0.35, 95% CI 0.12-0.96), stage 3 AKI (OR 0.12, 95% CI 0.29-0.93), and the combined safety end point (OR 0.52, 95% CI 0.29-0.93). One-year survival improved significantly (T1 79% vs T3 86%, P = .016). CONCLUSIONS: Over time, TAVI is performed with significant reductions in major vascular complications, life-threatening bleedings, and the combined clinical safety end point and improved 1-year survival.

Impact of preoperative chronic kidney disease on short- and long-term outcomes after transcatheter aortic valve implantation: a Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC-Plus) initiative substudy.

BACKGROUND: Only limited and conflicting data on the impact of preoperative chronic kidney disease (CKD) on outcomes after transcatheter aortic valve implantation (TAVI) are available. METHODS: We retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers (942 patients). Valve Academic Research Consortium end point definitions were used. The outcomes were compared among patients with normal estimated glomerular filtration rate (≥90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe (<30 mL/min) CKD and those on chronic hemodialysis (HD). The primary end point was 1-year survival. RESULTS: A total of 109 patients had a normal estimated glomerular filtration rate (11.6%); 329 (34.9%) had mild, 399 (42.5%) moderate, 72 (7.5%) severe CKD, and 33 (3.5%) were on HD. Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE. Major stroke, life-threatening bleeding, all-cause 30-day mortality (HD 15.2%, severe CKD 8.3%, moderate CKD 8.3%, mild CKD 6.7%, normal 1.8%, P = .007) and 1-year survival (HD 54.8%, severe CKD 67.2%, moderate CKD 80.0%, mild CKD 85.2%, normal eGFR 91.4%, HD vs severe CKD P = .23, severe CKD vs moderate CKD P = .002, moderate CKD vs mild CKD P = .04, moderate CKD vs normal eGFR P = .03, by log-rank test) differed significantly across groups. Through multivariable analysis, HD and severe CKD were independently associated with an increased risk of 1-year mortality (hazard ratios 5.07 [95% CI 1.79-14.35, P = .002] and 4.03 [95% CI 1.52-10.69, P = .005], respectively). CONCLUSIONS: Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes. Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI.

Current management of left main coronary artery disease.

Coronary artery bypass surgery is considered as the gold standard treatment of unprotected left main coronary artery (ULMCA) disease. Over the last 20 years, improvement in stent technology and operators experience explained the increased number of reports on the results of percutaneous coronary interventions (PCIs) for the treatment of left main (LM) coronary artery lesion. The recent data comparing efficacy and safety of PCIs using drug-eluting stent and coronary artery bypass surgery showed comparable results in terms of safety and a lower need for repeat revascularization for coronary artery bypass surgery. Patient selection for both techniques is fundamental and directly impacts the clinical outcome. Further randomized trials must be conducted to precise the indications of both techniques of revascularization in the treatment of LM disease.

Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study.

BACKGROUND: R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI. AIMS: We aimed to evaluate the safety and efficacy of the R-One system for PCI. METHODS: The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured. RESULTS: Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table. CONCLUSIONS: This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. (ClinicalTrials.gov: NCT04163393).

Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes.

Background: Intravascular lithotripsy (IVL) for calcified lesion preparation prior to drug-eluting stent placement has high procedural success and safety, especially in women, whereas other atheroablative approaches are associated with increased procedural complications. We sought to investigate long-term sex-based outcomes of IVL-facilitated stenting. Methods: We performed a patient-level pooled analysis of the single-arm Disrupt CAD III and IV studies. Patient baseline, procedural characteristics, and outcomes were examined according to sex at 30 days and 1 year. The primary end point was major adverse cardiac events (a composite of cardiac death, all myocardial infarction, or target vessel revascularization). Target lesion failure was defined as cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Results: A total of 448 patients, 106 (24%) women, were included. Women were older and less likely to be smokers. Women had smaller reference vessel diameters (2.8 mm vs 3.1 mm), shorter lesion length (23.6 mm vs 27.1 mm), and shorter total calcified length (44.4 mm vs 49.3 mm) compared with men. Post-IVL angiographic outcomes and complications were similar between women and men. At 1 year, major adverse cardiac event rates (12.3% vs 13.2%, P = .52) were not different between women and men. There were no differences between women and men (10.4% vs 11.2%; P = .43) in target lesion failure at 1 year. Conclusions: Use of IVL in the treatment of severely calcified lesions is associated with low rates of adverse clinical events and with similar safety and effectiveness in women and men at 1 year.