Clinical Outcomes of Left Main Coronary Artery PCI With Rotational Atherectomy.

Data regarding rotational atherectomy percutaneous coronary intervention (RA PCI) angioplasty in the left main (LM) coronary artery are scarce, and mostly outdated. We aimed to describe clinical outcomes of RA PCI in LM. Patients requiring RA in 8 European countries and 19 centers were prospectively and consecutively included in the European registry of Cardiac Care of Calcified and Complex patients registry. In-hospital data collection and 1-year follow-up were performed for each patient. Between October 2016 and July 2018, 966 patients with complete data were included. Among them, 241 presented with an LM lesion, and 171 required an LM lesion preparation by RA. The latter, allocated to the LM-RA group, were compared with the 725 patients in the non-LM-RA group. Clinical success of the RA procedure was comparable in both groups, but in-hospital major adverse cardiac events were higher in the RA-LM group (7.6% vs 3.2%, adjusted p = 0.04), mainly driven by a higher in-hospital mortality rate (5.3 vs 0.3%, adjusted p = 0.005). At 1-year follow-up, mortality and major adverse cardiac event rates were comparable in both groups (12.9% vs 8.0%, adjusted p value: 0.821, and 15.8% vs 10.9%, adjusted p value: 0.329, respectively), but the rate of target vessel revascularization remained higher in the RA-LM group (5.3% vs 3.2%, adjusted p = 0.021). In conclusion, RA PCI is an efficient option for calcified LM lesions, providing acceptable outcomes regarding this population with high risk at 1 year, and yields comparable outcomes with RA PCI performed on non-LM lesions.

Retrograde Chronic Total Occlusion Percutaneous Coronary Interventions: Predictors of Procedural Success From the ERCTO Registry.

OBJECTIVES: The aim of this study was to identify independent predictors of procedural success after retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Retrograde CTO PCI is an established technique, but predictors of success remain poorly understood. METHODS: A multivariable logistic regression model was used to analyze potentially important demographic, clinical, anatomical, and technical aspects of retrograde CTO PCI cases uploaded to the multicenter European CTO (ERCTO) Club Registry. RESULTS: In calendar years 2018 and 2019, 2,364 retrograde CTO PCI cases constituted the primary analysis cohort. A primary retrograde strategy was used in 1,953 cases (82.6%), and an initial antegrade approach was converted to retrograde in 411 cases (17.4%). Procedural success was achieved in 1,820 cases (77.0%) and was more likely to occur after a primary retrograde attempt versus conversion from an initial antegrade approach (80.9% vs 58.4%; P < 0.0001). After multivariable analysis, an absence of lesion calcification (OR: 1.86; 95% CI: 1.37-2.51; P < 0.0001), a higher degree of distal vessel opacification (OR: 2.47; 95% CI: 1.72-3.55; P < 0.0001), little or no proximal target vessel tortuosity (OR: 1.84; 95% CI: 1.28-2.64; P = 0.001), Werner collateral connection CC1 (OR: 4.87; 95% CI: 2.90-8.19; P < 0.0001) or CC2 (OR: 5.33; 95% CI: 3.02-9.42; P < 0.0001), and the top tertile of operator volume (>120 cases over 2 years) (OR: 1.88; 95% CI: 1.26-2.79; P = 0.002) were associated with the greatest chance of achieving angiographic success. CONCLUSIONS: Less calcification with good distal vessel opacification, little or absent proximal vessel tortuosity, and visible collateral connections, along with high-volume operator status, were all independently predictive of angiographically successful retrograde CTO PCI.

Dual lumen microcatheters for recanalisation of chronic total occlusions: a EuroCTO Club expert panel report.

Dual lumen microcatheters (DLMC) have become indispensable tools in the setting of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). Other than allowing preservation and treatment of bifurcated coronary branches within or in the proximity of the CTO body, they enable the use of modified parallel wiring, antegrade dissection and re-entry, collateral selection and retrograde negotiation of the distal CTO cap. This EuroCTO consensus document describes current DLMC and suggests a practical guide to anatomies and techniques in which these devices are applicable.

Radiation Exposure for Percutaneous Interventions of Chronic Total Coronary Occlusions in a Multicenter Registry: The Influence of Operator Variability and Technical Set-up.

AIMS: Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose. METHODS AND RESULTS: We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 ± 1.44 to 2.46 ± 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy•cm² (IQR, 70-241 Gy•cm²) to 102 Gy•cm² (IQR, 58-184 Gy•cm²). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences. CONCLUSIONS: Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.

Prognostic Impact of Percutaneous Coronary Intervention of Chronic Total Occlusion in Acute and Periprocedural Myocardial Infarction.

Coronary chronic total occlusion (CTO) has gained increasing clinical attention as the most advanced form of coronary artery disease. Prior studies already indicated a clear association of CTO with adverse clinical outcomes, especially in patients with acute myocardial infarction (AMI) and concomitant CTO of the non-infarct-related coronary artery (non-IRA). Nevertheless, the prognostic impact of percutaneous coronary intervention (PCI) of CTO in the acute setting during AMI is still controversial. Due to the complexity of the CTO lesion, CTO-PCI leads to an increased risk of complications compared to non-occlusive coronary lesions. Therefore, this review outlines the prognostic impact of CTO-PCI in patients with AMI. In addition, the prognostic impact of periprocedural myocardial infarction caused by CTO-PCI will be discussed.

Effect of Sex on Outcomes of Coronary Rotational Atherectomy Percutaneous Coronary Intervention (From the European Multicenter Euro4C Registry).

Data regarding the potential influence of gender on outcomes of rotational atherectomy (RA) percutaneous coronary intervention (PCI) are scarce and conflicting. Using the Euro4C registry, an international prospective multicentric registry of RA PCI, we evaluated the influence of gender on clinical outcomes of RA PCI. Between October 2016 and July 2018, 966 patients were included. In them, 267 (27.6%) were females. Female patients were older than males (77.7 years old ± 9.8 vs 73.3 ± 9.5 years old respectively, p < 0.001) had a poorer renal function (43,1% of females had a GFR < 60 ml/min:1.73m² vs 30.4% of males, p < 0.001) and were more frequently admitted for an acute coronary syndrome (32.2% vs 22.3% p = 0.002). During RA procedure, women were less likely to be treated by radial approach (65.0% vs 74.4%, p = 0.004). In-hospital major adverse cardiac event rate-defined as cardiovascular death, myocardial infarction, stroke/transient ischemic attack, target lesion revascularization, and coronary artery bypass grafting surgery-was higher in the female group (7.1% vs 3.7%, p = 0.043). However, coronary perforation, dissection, slow/low flow and tamponade did not significantly differ in gender, neither did cardiovascular medications at discharge. At 1 year follow-up, rate of major adverse cardiac event was 18.4% in the female group vs 11.2% in the male group (adjusted Hazard Ratio 1.82 [1.24 to 2.67], p = 0.002). No significant bleeding differences were observed in gender, neither in hospital, nor during follow-up. In conclusion women had worse clinical outcomes following RA PCI during hospitalization and at 1 year follow-up than did men.

Clinical outcomes of PCI with rotational atherectomy: the European multicentre Euro4C registry.

AIMS: Despite the use of rotational atherectomy (RA) in interventional cardiology for over three decades, data regarding factors affecting the clinical outcomes of the RA procedure remain scarce. The aim of the present study was to describe the contemporary use and outcomes of RA in Europe. METHODS AND RESULTS: We conducted, for the first time, a prospective international registry in 8 European countries and 19 centres and included patients treated by percutaneous coronary intervention with RA. Between October 2016 and July 2018, 966 patients with complete data were recruited. Mean age was 74.5 years, 72.4% were male and 43.4% had diabetes. Initial presentation was an acute coronary syndrome (ACS) for 25.1% of the patients. Clinical success was observed in 91.9% of the procedures. The rate of in-hospital major adverse cardiac events (MACE) - defined as cardiovascular death, myocardial infarction, target lesion revascularisation, stroke and coronary artery bypass grafting - was 4.7%. At one year, the rate of MACE was 13.2%. Factors independently associated with the occurrence of MACE at one year were female gender, renal failure, ACS at admission, depressed left ventricular ejection fraction (LVEF) and presence of a significant left main coronary artery (LMCA) lesion. CONCLUSIONS: Despite the high level of complexity of the studied population, RA turned out to be an effective procedure with a low rate of in-hospital complications and demonstrated good immediate and midterm results.

Prospective evaluation of drug eluting self-apposing stent for the treatment of unprotected left main coronary artery disease: 1-year results of the TRUNC study.

OBJECTIVES: To assess long-term safety and efficacy of the Xposition S self-apposing stent in the treatment of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: Percutaneous intervention with stents has emerged as a valid alternative to surgical revascularization to treat ULMCA disease. Conventional balloon-expandable stents face technical challenges, particularly in large left main diameter requiring extensive optimization and side branch access in distal bifurcation. Xposition S allows for optimal apposition, bridging diameter differences, and allows expansion to vessel diameters up to 6.0 mm. METHODS: Between June 2016 and July 2017, 205 patients were enrolled in this international, prospective, multicenter registry. Patients with SYNTAX score ≥ 33 or recent STEMI were excluded. IVUS during procedure was performed in a prespecified subgroup of 50 patients. The primary clinical endpoint was 12 months Target lesion failure (TLF) and the primary efficacy endpoint was angiographic success. RESULTS: Distal left main bifurcation was involved in 92.7%, treated with provisional approach in most cases (79.4%). TLF rate at 12 months was 8.3%, which was defined as a composite of cardiac death (2.0%), target-vessel MI (2.9%), and TLR (5.4%). Most revascularizations occurred at SB ostium. IVUS analysis demonstrated optimal stent apposition with only one reported malapposition and promising poststenting minimal stent area measures. CONCLUSIONS: The TRUNC study confirms that Xposition S self-apposing stent is a valid and feasible option for the treatment of ULMCA disease. Such results were reached without the systematic need of stent optimisation techniques, focusing mainly on lesion treatment.

Temporal Trends in Chronic Total Occlusion Interventions in Europe.

BACKGROUND: The study focuses on the evolution of practice, procedural outcomes, and in-hospital complications of chronic total occlusion percutaneous coronary intervention in Europe. METHODS AND RESULTS: Data from 17 626 procedures enrolled in European Registry of Chronic Total Occlusion between January 2008 and June 2015 were assessed. The mean patient age was 63.9±10.9 years; 85% were men. Procedural success increased from 79.7% to 89.3% through the study period. Patients enrolled during the years had increasing comorbidities and lesion complexity (J-CTO score [Multicenter CTO Registry of Japan] increased from 1.76±1.03 in 2008 to 2.17±0.91 in 2015; P for trend, <0.001). Retrograde approach utilization steadily increased from 10.1% in 2008 to 29.9% in 2015 ( P for trend, <0.001). Antegrade dissection reentry adoption was low, not exceeding 5.5%. In-hospital mortality decreased during the study period from 0.4% to 0.1% ( P for trend, <0.001), whereas in-hospital complication rates remained essentially unchanged, in the range 4.4% to 5.2% ( P for trend, 0.390). CONCLUSIONS: Chronic total occlusion percutaneous coronary intervention has shown a steady increase in procedural success rate over time, with unchanged complication rates, despite the increasing complexity of the lesions attempted. The J-CTO score predictive value for procedural success was low for the entire registry and had no predictive ability for the retrograde approach.

Clinical performance of a dedicated self-apposing stent for the treatment of left main stem disease. Results of the left Main AngioplasTy wIth a Self-apposing StEnt - the MATISSE study.

BACKGROUND: In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease. METHODS AND RESULTS: MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348±52days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late. CONCLUSIONS: A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up.

Telescopic Corsair in 5F Guidion for Retrograde Recanalization of Complex Chronic Total Occlusions (CTOs).

BACKGROUND Retrograde advancement of microcatheters through septal/epicardial connectors can be challenging. Although several tricks might help to do so (e.g., balloon trap of retro wire in second guiding, balloon trap of retro wire in native coronary artery, and use of antegrade extension to approximate the antegrade conduit to the retrograde gear), these tricks cannot always be applied, especially in patients with poor access. Also, puncturing, knuckling, and crossing of the distal CTO cap (or the aorta as described in 1 of the cases) sometimes needs a lot of backup of the microcatheter. CASE REPORT We describe 3 cases in which we used a novel telescopic technique with 5F Guidion (IMDS®) supported retrograde Corsair (Asahi®) advancement in complex CTO lesions. CONCLUSIONS The telescopic Corsair in 5F Guidion may offer the support needed to end successfully in these situations.

The first clinical experience with a novel "locking" microcatheter in chronic coronary total occlusions.

AIMS: A novel "locking" microcatheter has been developed to address residual failure modes in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The aim of this study was to report the first clinical experience of this device. METHODS AND RESULTS: The microcatheter was assessed prospectively in 92 unselected CTO cases across six European sites. Overall technical success was 85.9% (79/92) and 97.5% for patients with a J-CTO score of <3 (39/40). Within-CTO tortuosity was the only lesion characteristic to predict reduced technical success (OR 0.10 [0.01-0.97], p=0.047). Calcification (OR 0.45 [0.04-5.31], p=0.53), lesion length >20 mm (OR 0.58 [0.05-6.81], p=0.66) and a blunt proximal cap (OR 0.47 [0.08-2.90], p=0.42) were not associated with technical failure in this case series. Locking facilitated guidewire crossing (after initial failure) of the proximal cap in 23 cases, distal cap in 11 cases and CTO body in 10 cases, and delivery of the microcatheter through to the distal vessel in 22 cases. The overall procedural complication rate was 1.1% (1/92) with no major events. CONCLUSIONS: Guidewire locking with this novel microcatheter assists penetration and crossing of fibrocalcific anatomy with a high degree of safety. Using this device in CTO PCI may lead to improved primary wiring and overall procedural success rates.

Retrograde Recanalization of Chronic Total Occlusions in Europe: Procedural, In-Hospital, and Long-Term Outcomes From the Multicenter ERCTO Registry.

BACKGROUND: A retrograde approach improves the success rate of percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs). OBJECTIVES: The authors describe the European experience with and outcomes of retrograde PCI revascularization for coronary CTOs. METHODS: Follow-up data were collected from 1,395 patients with 1,582 CTO lesions enrolled between January 2008 and December 2012 for retrograde CTO PCI at 44 European centers. Major adverse cardiac and cerebrovascular events were defined as the composite of cardiac death, myocardial infarction, stroke, and further revascularization. RESULTS: The mean patient age was 62.0 ± 10.4 years; 88.5% were men. Procedural and clinical success rates were 75.3% and 71.2%, respectively. The mean clinical follow-up duration was 24.7 ± 15.0 months. Compared with patients with failed retrograde PCI, successfully revascularized patients showed lower rates of cardiac death (0.6% vs. 4.3%, respectively; p < 0.001), myocardial infarction (2.3% vs. 5.4%, respectively; p = 0.001), further revascularization (8.6% vs. 23.6%, respectively; p < 0.001), and major adverse cardiac and cerebrovascular events (8.7% vs. 23.9%, respectively; p < 0.001). Female sex (hazard ratio [HR]: 2.06; 95% confidence interval [CI]: 1.33 to 3.18; p = 0.001), prior PCI (HR: 1.73; 95% CI: 1.16 to 2.60; p = 0.011), low left ventricular ejection fraction (HR: 2.43; 95% CI: 1.22 to 4.83; p = 0.011), J-CTO (Multicenter CTO Registry in Japan) score ≥3 (HR: 2.08; 95% CI: 1.32 to 3.27; p = 0.002), and procedural failure (HR: 2.48; 95% CI: 1.72 to 3.57; p < 0.001) were independent predictors of major adverse cardiac and cerebrovascular events at long-term follow-up. CONCLUSIONS: The number of retrograde procedures in Europe has increased, with high percents of success, low rates of major complications, and good long-term outcomes.

European expert consensus on rotational atherectomy.

The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.