Adverse events in patients with high platelet reactivity following successful chronic total occlusion PCI: The Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents (ADAPT-DES) study.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) typically requires a greater number of stents and longer stent length than non-CTO PCI, placing these patients at greater risk for adverse ischemic events. We sought to determine whether the association between high platelet reactivity (HPR) and the risk of ischemic events is stronger after CTO than non-CTO PCI. METHODS: Patients undergoing successful PCI in the multicenter ADAPT-DES study were stratified according to whether they underwent PCI of a CTO. HPR was defined as VerifyNow platelet reaction units >208. The study primary endpoint was the 2-year risk target vessel failure ([TVF] defined as cardiac death, myocardial infarction, or target lesion revascularization). RESULTS: CTO PCI was performed in 400 of 8448 patients. HPR was present in 34.5% of CTO PCI patients and 43.1% of non-CTO PCI patients (P = .0007). Patients undergoing CTO PCI with versus without HPR had significantly higher 2-year rates of TVF (15.0% versus 8.3%, P = .04) without significant differences in bleeding. HPR was an independent predictor of 2-year TVF (adjusted HR 1.16, 95% CI 1.02-1.34, P = .03) whereas CTO PCI was not (adjusted HR 0.89, 95% CI 0.65-1.22, P = .48). There was a significant interaction between CTO versus non-CTO PCI and PRU as a continuous variable for 2-year TVF (Pinteraction = 0.02). CONCLUSIONS: In ADAPT-DES, HPR was associated with an increased 2-year risk of TVF after PCI, an association that was at least as strong after CTO PCI compared with non-CTO PCI.

In-Hospital Costs and Costs of Complications of Chronic Total Occlusion Angioplasty: Insights From the OPEN-CTO Registry.

OBJECTIVES: The aim of this study was to describe the costs of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and the association of complications during CTO PCI with costs and length of stay (LOS). BACKGROUND: CTO PCI generally requires more procedural resources and carries higher risk for complications than PCI of non-CTO vessels. The costs of CTO PCI using the hybrid approach have not been described, and no studies have examined the impact of complications on in-hospital costs and LOS in this population. METHODS: Costs were calculated for 964 patients in the 12-center OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry using prospectively collected resource utilization and billing data. Multivariate models were developed to estimate the incremental costs and LOS associated with complications. Attributable costs and LOS were calculated by multiplying the independent cost of each event by its frequency in the population. RESULTS: Mean costs for the index hospitalization were $17,048 ± 9,904; 14.5% of patients experienced at least 1 complication. Patients with complications had higher mean hospital costs (by $8,603) and LOS (by 1.5 days) than patients without complications. Seven complications were independently associated with increased costs and 6 with LOS; clinically significant perforation and myocardial infarction had the greatest attributable cost per patient. Overall, complications accounted for $911 per patient in hospital costs (5.3% of the total costs) and 0.2 days of additional LOS. CONCLUSIONS: Complications have a significant impact on both LOS and in-hospital costs for patients undergoing CTO PCI. Methods to identify high-risk patients and develop strategies to prevent complications may reduce CTO PCI costs.

Intravascular Ultrasound Assessment of In-Stent Restenosis in Saphenous Vein Grafts.

Outcomes after percutaneous coronary interventions (PCI) in saphenous vein grafts (SVG) are inferior compared with native coronary arteries, but the mechanisms of SVG in-stent restenosis (ISR) have not been well-described. Thus, we aimed to evaluate the patterns of SVG ISR using intravascular ultrasound (IVUS) in 54 SVG ISR lesions. Stent underexpansion was defined as minimum stent area (MSA) <5 mm2. The time from stent implantation to presentation with ISR (9 BMS, 18 first-generation DES, and 27 second-generation DES) was 3.7 ± 3.0 years. IVUS-defined ISR patterns were categorized as mechanical (33%) or biological (67%). Mechanical patterns comprised 10 cases of stent underexpansion (MSA = 4.2 ± 0.9 mm2), 6 stent fractures or deformations, and 2 uncovered aorto-anastomotic lesions. Biological patterns comprised 19 cases of neoatherosclerosis, 13 excessive neointimal hyperplasia (NIH, 65 ± 11%), and 4 thrombi. Compared with biological patterns of ISR, mechanical patterns were more frequently located at the SVG anastomosis (72% vs 39%, p = 0.04) and at the SVG hinge motion site (55% vs 21%, p = 0.02). Although patients with mechanical patterns of ISR presented earlier than those with biological patterns (2.3 vs 4.4 years, p = 0.009), 61% of them were diagnosed >1 year after stent implantation. In conclusion, SVG ISR is dominated by biological patterns including neoatherosclerosis. Mechanical patterns of SVG ISR are associated with earlier presentation and location at graft anastomosis or hinge motion site.

Virtual Functional Assessment of Coronary Stenoses Using Intravascular Ultrasound Imaging: A Proof-of-Concept Pilot Study.

AIMS: We aimed to investigate the performance of virtual functional assessment of coronary stenoses using intravascular ultrasound (IVUS)-based three-dimensional (3D) coronary artery reconstruction against the invasively measured fractional flow reserve (FFR). METHODS AND RESULTS: Twenty-two (22) patients with either typical symptoms of stable angina or a positive stress test, who underwent IVUS and FFR, were included in this study. Five (5) patients presented FFR values lower than the 0.80 threshold, indicating ischaemia. IVUS-based 3D reconstruction and blood flow simulation were performed and the virtual functional assessment index (vFAI) was calculated. A strong correlation between IVUS-based vFAI and FFR was observed (Spearman correlation coefficient [rs]=0.88, p<0.0001). There was a small overestimation of the FFR by the IVUS-based vFAI (mean difference=0.0196±0.037; p=0.023 for difference from zero). All cases with haemodynamically significant stenoses (FFR≤0.8) were correctly categorised by the IVUS-based vFAI (vFAI≤0.8). CONCLUSION: The proposed approach allows the complete and comprehensive assessment of coronary stenoses providing anatomic and physiologic information, pre- and post-intervention, using only an IVUS catheter without the use of a pressure wire.

Association of Stress Test Risk Classification With Health Status After Chronic Total Occlusion Angioplasty (from the Outcomes, Patient Health Status and Efficiency in Chronic Total Occlusion Hybrid Procedures [OPEN-CTO] Study).

Stress testing is endorsed by the American College of Cardiology/American Heart Association Appropriate Use Criteria to identify appropriate candidates for Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI). However, the relation between stress test risk classification and health status after CTO PCI is not known. We studied 449 patients in the 12-center OPEN CTO registry who underwent stress testing before successful CTO PCI, comparing outcomes of patients with low-risk (LR) versus intermediate to high-risk (IHR) findings. Health status was assessed using the Seattle Angina Questionnaire Angina Frequency (SAQ AF), Quality of Life (SAQ QoL), and Summary Scores (SAQ SS). Stress tests were LR in 40 (8.9%) and IHR in 409 (91.1%) patients. There were greater improvements on the SAQ AF (LR vs IHR 14.2 ± 2.7 vs 23.3 ± 1.3 points, p <0.001) and SAQ SS (LR vs IHR 20.8 ± 2.3 vs 25.4 ± 1.1 points, p = 0.03) in patients with IHR findings, but there was no difference between groups on the SAQ QoL domain (LR vs IHR 24.8 ± 3.4 vs 27.3 ± 1.6 points, p = 0.42). We observed large health status improvements after CTO PCI in both the LR and IHR groups, with the greatest reduction in angina among those with IHR stress tests. Although patients with higher risk studies may experience greater reduction in angina symptoms, on average, patients with LR stress tests also experienced large improvements in symptoms after CTO PCI, suggesting patients with refractory symptoms should be considered appropriate candidates for CTO PCI regardless of stress test findings.

The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design.

BACKGROUND: Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure. METHODS: To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs. RESULTS: Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar. CONCLUSION: OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.

Prevalence, indications and management of balloon uncrossable chronic total occlusions: Insights from a contemporary multicenter US registry.

BACKGROUND: Balloon uncrossable lesions can be challenging to treat, requiring specialized techniques and equipment. METHODS: We examined the prevalence, clinical and angiographic characteristics, management and procedural outcomes of balloon uncrossable lesions in a multicenter chronic total occlusion (CTO) percutaneous coronary intervention (PCI) registry. RESULTS: Between 2012 and 2016, 718 CTO PCIs (in which the occlusion was successfully crossed with a guidewire) were performed in 701 patients at 11 US centers. Mean age was 65.6 ± 10 years and 84% of the patients were men. Balloon uncrossable lesions represented 9% of all CTOs. Balloon uncrossable CTOs had more moderate/severe calcification (82% vs. 52%, P < 0.0001), moderate/severe tortuosity (61% vs. 35% P < 0.0001) and higher J-CTO score (2.95 ± 1.32 vs. 2.43 ± 1.23, P = 0.005) as compared with the remaining lesions. Technical and procedural success was significantly lower for balloon uncrossable lesions (90.5% vs. 98.3%, P < 0.0001 and 88.9% vs. 96.6% P = 0.004), respectively, but the incidence of major adverse events was similar (1.6% vs. 2.2%, P = 0.751). Balloon uncrossable lesions required longer procedure (208 [interquartile range: 135, 258] vs. 135 [94, 194] min, P < 0.0001) and fluoroscopy (77 [52, 100] vs. 45 min [27, 75], P < 0.0001) time. Techniques used to treat balloon uncrossable lesions included balloon-assisted microdissection (23%), excimer laser atherectomy (18%), and rotational atherectomy (16%). Excimer laser atherectomy and balloon-assisted microdissection were associated with the highest technical and procedural success rates. CONCLUSIONS: Balloon uncrossable CTOs are common, are associated with high rates of technical failure, and require specialized techniques for successful treatment. © 2016 Wiley Periodicals, Inc.

Development of a high-volume, multiple-operator program for percutaneous chronic total coronary occlusion revascularization: procedural, clinical, and cost-utilization outcomes.

BACKGROUND: Development of a specialized chronic total coronary occlusion (CTO) revascularization program attentive to procedural guidelines, quality oversight, and cost/resource utilization has not been described. METHODS: A single-center CTO interventional program was initiated with requirements including: extensive didactic training, on-site proctorship, routine determination of case appropriateness, adherence to procedural safety guidelines, and a 2-operator/case approach. Clinical and angiographic characteristics, procedural outcomes, in-hospital clinical events, and cost/resource utilization were examined. RESULTS: Among 145 patients, 160 consecutive CTO revascularization procedures were attempted between October 2009 and December 2010. Selected procedural and technical characteristics included: bilateral femoral access, 90.0%; planned retrograde guidewire placement, 37.5%; re-entry catheter, 10.0%; reattempt, 10.6%; fluoroscopic time, 67.4 ± 45.5 min; contrast volume, 403 ± 215 mL. Average stent number and total stent length per CTO vessel were 2.6 ± 1.1 and 64.7 ± 30.7 mm, respectively. Overall CTO success rate was 85.6% (137/160). In-hospital adverse outcomes included: death 0.6%; emergency bypass surgery, 0.6%; tamponade, 0.6%; myocardial infarction, 1.9%; transient nephropathy, 1.2%. Compared with patients undergoing non-CTO PCI, procedural and total cost per patient were significantly higher among the CTO cohort despite overall similar contribution margins ($5,173 ± 12,052 versus $5,730 ± 8,958, P = 0.58). CONCLUSIONS: Following initiation of a dedicated program with implementation of quality and performance guidelines, complex CTO revascularization may be safely performed with outcomes comparable with reports from established centers. Despite higher resource utilization, CTO revascularization is associated with a positive contribution margin. Requirement of educational and performance standards, mentorship from experts, consensus review for appropriateness and provision of catheterization laboratory policies may represent a model for program development.

Percutaneous Chronic Total Occlusion Revascularization: Program Development, Resource Utilization, and Economic Outcomes.

Against the background of current data supporting indications for chronic total occlusion (CTO) revascularization and strategies that promote incrementally higher procedural success rates, this article introduces a multidisciplinary approach to CTO program development, establishes guidelines for the performance of safe and efficient CTO percutaneous coronary intervention, and reviews considerations related to resource utilization and economic outcomes with complex percutaneous coronary revascularization.

Prospective validation of standardized, 3-dimensional, quantitative coronary computed tomographic plaque measurements using radiofrequency backscatter intravascular ultrasound as reference standard in intermediate coronary arterial lesions: results from the ATLANTA (assessment of tissue characteristics, lesion morphology, and hemodynamics by angiography with fractional flow reserve, intravascular ultrasound and virtual histology, and noninvasive computed tomography in atherosclerotic plaques) I study.

OBJECTIVES: This study sought to determine the accuracy of 3-dimensional, quantitative measurements of coronary plaque by computed tomography angiography (CTA) against intravascular ultrasound with radiofrequency backscatter analysis (IVUS/VH). BACKGROUND: Quantitative, 3-dimensional coronary CTA plaque measurements have not been validated against IVUS/VH. METHODS: Sixty patients in a prospective study underwent coronary X-ray angiography, IVUS/VH, and coronary CTA. Plaque geometry and composition was quantified after spatial coregistration on segmental and slice-by-slice bases. Correlation, mean difference, and limits of agreement were determined. RESULTS: There was significant correlation for all pre-specified parameters by segmental and slice-by-slice analyses (r = 0.41 to 0.84; all p < 0.001). On a segmental basis, CTA underestimated minimal lumen diameter by 21% and overestimated diameter stenosis by 39%. Minimal lumen area was overestimated on CTA by 27% but area stenosis was only underestimated by 5%. Mean difference in noncalcified plaque volume and percent and calcified plaque volume and percent were 38%, -22%, 104%, and 64%. On a slice-by-slice basis, lumen, vessel, noncalcified-, and calcified-plaque areas were overestimated on CTA by 22%, 19%, 44%, and 88%. There was significant correlation for percentage of atheroma volume (0.52 vs. 0.54; r = 0.51; p < 0.001). Compositional analysis suggested that high-density noncalcified plaque on CTA best correlated with fibrous tissue and low-density noncalcified plaque correlated with necrotic core plus fibrofatty tissue by IVUS/VH. CONCLUSIONS: This is the first validation that standardized, 3-dimensional, quantitative measurements of coronary plaque correlate with IVUS/VH. Mean differences are small, whereas limits of agreement are wide. Low-density noncalcified plaque correlates with necrotic core plus fibrofatty tissue on IVUS/VH.