Association between J-CTO score and long-term target lesion revascularization rate after successful chronic total coronary occlusion angioplasty (from the J-CTO Registry).

OBJECTIVES: The aim of this study was to evaluate the impact of the J-CTO score on long-term target lesion revascularization (TLR) after successful native chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). BACKGROUND: We previously reported that the J-CTO score could be used to stratify the lesion complexity and procedural success rate in CTO lesions. METHODS: We evaluated the prognostic significance of a high J-CTO score for long-term TLR rate in the J-CTO Registry. RESULTS: In the 425 lesions of 408 patients who underwent successful CTO-PCI during a median follow-up of 63.0 (interquartile range: 21.2-72.9) months in the J-CTO Registry, the cumulative incidence of TLR of lesions with a J-CTO score ≥ 2 (n = 216) was significantly higher than in those with a J-CTO score ≤ 1 (n = 209) (27.0 versus 19.4% at 5 years, respectively, P = 0.04). Among 323 lesions of 309 patients with a complete 5-year follow-up, the rate of TLR was 28% (n = 91). A J-CTO score ≥ 2 was independently associated with a higher risk of TLR (odds ratio, 1.73; 95% confidence interval, 1.01-2.99, P = 0.048) even after adjustment for clinically relevant baseline factors. CONCLUSIONS: Patients with high J-CTO score lesions had a higher 5-year risk of TLR.

Clinical Experience of a Novel Optical Coherence Tomography-Guided Coronary Chronic Total Occlusion Re-Entry Device.

We demonstrated a first-in-human case of successful antegrade dissection and re-entry using an image-guided re-entry catheter that enables real-time high-resolution visualization with graphical augmentation, and precision steering and advancement of a guidewire. The total time from over-the-wire deployment in the proximity of the distal cap to successful re-entry was <20 minutes. (Level of Difficulty: Advanced.).

Impact of J-CTO score on procedural outcome and target lesion revascularisation after percutaneous coronary intervention for chronic total occlusion: a substudy of the J-CTO Registry (Multicentre CTO Registry in Japan).

AIMS: We investigated the impact of the J-CTO score, a pre-procedural risk score for successful guidewire crossing within 30 minutes through chronic total occlusion (CTO) lesions, on procedural and midterm clinical outcomes in terms of target lesion revascularisation (TLR) after CTO recanalisation. METHODS AND RESULTS: The primary endpoint of this substudy was midterm TLR. The net midterm success rate was calculated by multiplying the lesion success rate by the TLR-free survival rate. The initial lesion success rates according to the J-CTO score categories of 0, 1, 2, and ≥3 were 97.0%, 92.1%, 86.5%, and 73.6%, respectively (p<0.001). The TLR rates at one year according to the J-CTO score categories of 0, 1, 2, and ≥3 were 5.3%, 11.1%, 16.7%, and 13.4%, respectively (p=0.082). The net midterm success rates according to the J-CTO score categories of 0, 1, 2, and ≥3 were 91.9%, 81.9%, 72.1%, and 63.7%, respectively (p<0.001). CONCLUSIONS: Patients with CTO lesions with lower J-CTO scores are expected to achieve a high procedural success rate and an increased TLR-free survival rate. Patients with high J-CTO scores still remain an issue.

Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial.

OBJECTIVE: To present results of a registry of a novel vascular access device. BACKGROUND: Arterial access has been largely unchanged for 60 years. The Arstasis device creates a novel shallow-angle arterial access designed to facilitate hemostasis without use of a vascular closure device (VCD) or implantation of a foreign body for closure. This is the first publication to report the outcomes of Arstasis access. METHODS: Patients (n = 346) underwent routine diagnostic cardiac catheterization (Dx) at 8 sites in the United States. Patients were assessed for device success, time to hemostasis (TTH), early sit up, time to ambulation (TTA), time-to-discharge-eligibility (TTDe) as well as safety; 249 patients had Dx only, 97 crossed over to PCI. RESULTS: Device deployment was successful in 97%; the other 3% converted to routine access. Mean TTH and TTA for Dx were 4.0 ± 2.5 minutes and 1.5 ± 1.2 hours, respectively; for PCI it was 6.9 ± 5.1 minutes and 3.2 ± 3.3 hours. A subset of 245 patients (72.9%) sat up within 30 minutes after hemostasis; early sit-up was successful in all but 1 (99.6%). TTDe for Dx was 2.7 ± 1.6 hours. There were no major access-site related complications; minor complications were primarily subclinical hematomas in 1.2%. CONCLUSIONS: Arstasis access is associated with short TTH and TTA, early sit up after sheath pull, and accelerated TTDe, achieved without use of VCDs or implantation of a foreign body, with high success and minimal complication rates.

Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool.

OBJECTIVES: This study sought to establish a model for grading lesion difficulty in interventional chronic total occlusion (CTO) treatment. BACKGROUND: Owing to uncertainty of success of the procedure and difficulties in selecting suitable cases for treatment, performance of interventional CTO remains infrequent. METHODS: Data from 494 native CTO lesions were analyzed. To eliminate operator bias, the objective parameter of successful guidewire crossing within 30 min was set as an end point, instead of actual procedural success. All observations were randomly assigned to a derivation set and a validation set at a 2:1 ratio. The J-CTO (Multicenter CTO Registry of Japan) score was determined by assigning 1 point for each independent predictor of this end point and summing all points accrued. This value was then used to develop a model stratifying all lesions into 4 difficulty groups: easy (J-CTO score of 0), intermediate (score of 1), difficult (score of 2), and very difficult (score of ≥ 3). RESULTS: The set end point was achieved in 48.2% of lesions. Independent predictors included calcification, bending, blunt stump, occlusion length >20 mm, and previously failed lesion. Easy, intermediate, difficult, and very difficult groups, stratified by J-CTO score, demonstrated stepwise, proportioned, and highly reproducible differences in probability of successful guidewire crossing within 30 min (87.7%, 67.1%, 42.4%, and 10.0% in the derivation set and 92.3%, 58.3%, 34.8%, and 22.2% in the validation set, respectively). Areas under receiver-operator characteristic curves were comparable (derivation: 0.82 vs. validation: 0.76). CONCLUSIONS: This model predicted the probability of successful guidewire crossing within 30 min very well and can be applied for difficulty grading.

In-hospital outcomes of contemporary percutaneous coronary intervention in patients with chronic total occlusion insights from the J-CTO Registry (Multicenter CTO Registry in Japan).

OBJECTIVES: Our aim was to investigate in-hospital outcomes of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) using contemporary techniques. BACKGROUND: Despite its increasing popularity and technical complexity, clinical outcomes of PCI for CTO using contemporary techniques have not been adequately evaluated. METHODS: The J-CTO registry (multicenter CTO registry in Japan) is a large scale, multicenter registry enrolling consecutive patients undergoing PCI for CTO from 12 Japanese centers. In-hospital clinical outcomes were evaluated in 498 patients with 528 CTO lesions. RESULTS: Multiple wiring strategies were frequently attempted (parallel wiring 31% and retrograde approach 25%) with relatively long guidewire manipulation time (median 30 min). Utilizing these complex strategies, high procedural success rates (88.6% in the first attempt cases and 68.5% in the retry cases) were accomplished. In-hospital adverse event rates were strikingly low (cardiac death 0.2%, Q-wave myocardial infarction 0.2%, and stroke 0%). Potential disadvantages of these procedures, including a large amount of contrast volume (median 293 ml) and long fluoroscopic time (median 45 min), were not associated with serious clinical sequelae (contrast induced nephropathy 1.2% and radiation dermatitis 0%). Although coronary perforations were documented frequently by angiography (antegrade 7.2% and retrograde 13.6%), clinically significant perforation resulting in cardiac tamponade was rare (0.4%). CONCLUSIONS: Most CTO lesions can be safely and successfully treated with PCI utilizing contemporary advanced techniques. Invasiveness and potential risks of these strategies, which have been the greatest concerns of CTO treatment, may be acceptable in the majority of cases considering the actual incidences of related adverse events and the procedural success rates.

Mechanism of luminal gain with plaque excision in atherosclerotic coronary and peripheral arteries: assessment by histology and intravascular ultrasound.

OBJECTIVES: Using intravascular ultrasound (IVUS) and histology, the purpose of this study was to evaluate the occurrence of arterial wall overstretch and Dotter effect following revascularization with a plaque excision (PE) catheter compared with balloon angioplasty. BACKGROUND: Previous studies have demonstrated the safety and feasibility of plaque excision for the treatment of de novo coronary and peripheral atherosclerotic disease. However, whether mechanical vessel dilatation related to catheter insertion contributes to gains in the final luminal diameter is uncertain. METHODS: Treatment with PE was assessed in both a porcine model (6 lesions treated with balloon angioplasty or PE) using histology and in humans with IVUS. In the latter part of the study, IVUS study was performed before and immediately following PE in 21 patients with either coronary artery disease (N = 13) or femoral artery disease (N = 8). Ultrasound measures in the femoral artery group were then compared with a control group of atherosclerotic lesions treated with conventional angioplasty that was matched according to lesion location and vessel diameter. RESULTS: Among individuals with coronary and peripheral arterial lesions treated with PE, the relative increases in luminal area secondary to reductions in plaque volume were 89% and 83%, respectively, with minimal increase in vessel diameter. In contrast, balloon angioplasty was associated with significantly greater vessel expansion and less plaque volume reduction. Vessel dissection also tended to occur less frequently and to a lesser extent with PE. CONCLUSIONS: Improvement in luminal dimensions using PE is principally due to a reduction in plaque volume rather than mechanical vessel expansion. The potential to increase luminal area while minimizing arterial dissection and barotrauma merits further clinical study with this method of revascularization.

Early experience with a novel plaque excision system for the treatment of complex coronary lesions.

The use of directional coronary atherectomy (DCA) in current practice has been limited. The SilverHawk System is a newly developed plaque excision device that aims to overcome the drawbacks of prior DCA platforms. The device was evaluated in a porcine coronary model and in a series of patients. Procedural variables along with outcomes were reviewed. Quantitative angiography (QCA) was performed and excised tissue fragments were weighed and examined histologically. In porcine cases, pretreatment MLD increased from 0.51 +/- 0.26 to 2.36 +/- 0.59 mm postdebulking and 19.9 +/- 7.6 mg of tissue was retrieved. In human cases, pretreatment MLD increased from 0.8 +/- 0.4 to 2.2 +/- 0.5 mm postdebulking and 15.2 +/- 7.8 mg of tissue was retrieved without complications. These data show that the SilverHawk System may offer significant utility in treating a wide variety of complex coronary lesions.