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Percutaneous treatment of heavily calcified coronary lesions remains a challenge for interventional cardiologists with increased risk of incomplete lesion preparation, suboptimal stent deployment, procedural complications, and a higher rate of acute and late stent failure. Adequate lesion preparation through calcium modification is crucial in optimising procedural outcomes. Several calcium modification devices and techniques exist, with rotational atherectomy the predominant treatment for severely calcified lesions. Novel technologies such as intravascular lithotripsy are now available and show promise as a less technical and highly effective approach for calcium modification. Emerging evidence also emphasises the value of detailed characterisation of calcification severity and distribution especially with intracoronary imaging for appropriate device selection and individualised treatment strategy. This review aims to provide an overview of the non-invasive and invasive evaluation of coronary calcification, discuss calcium modification techniques and propose an algorithm for the management of calcified coronary lesions.

Background Given that percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) is indicated primarily for symptom relief, identifying patients most likely to benefit is critically important for patient selection and shared decision‐making. Therefore, we identified factors associated with residual angina frequency after CTO PCI and developed a model to predict postprocedure anginal burden. Methods and Results Among patients in the OPEN‐CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated the association between patient characteristics and residual angina frequency at 6 months, as assessed by the Seattle Angina Questionnaire Angina Frequency Scale. We then constructed a prediction model for angina status after CTO PCI using ordinal regression. Among 901 patients undergoing CTO PCI, 28% had no angina, 31% had monthly angina, 30% had weekly angina, and 12% had daily angina at baseline. Six months later, 53% of patients had a ≥20‐point increase in Seattle Angina Questionnaire Angina Frequency Scale score. The final model to predict residual angina after CTO PCI included baseline angina frequency, baseline nitroglycerin use frequency, dyspnea symptoms, depressive symptoms, number of antianginal medications, PCI indication, and presence of multiple CTO lesions and had a C index of 0.78. Baseline angina frequency and nitroglycerin use frequency explained 71% of the predictive power of the model, and the relationship between model components and angina improvement at 6 months varied by baseline angina status. Conclusions A 7‐component OPEN‐AP (OPEN‐CTO Angina Prediction) score can predict angina improvement and residual angina after CTO PCI using variables commonly available before intervention. These findings have implications for appropriate patient selection and counseling for CTO PCI.

BACKGROUND Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality. METHODS Among 1,000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were reviewed by the angiographic core-lab. Eighty-nine patients (8.9%) with angiographic perforation were compared to 911 patients without perforation. We sought to describe the clinical and angiographic predictors of angiographic perforation during CTO PCI and develop a risk prediction model. RESULTS Among eight clinically important candidate variables, independent risk factors for perforation included prior CABG (OR 2.0 [95% CI, 1.2-3.3], p

OBJECTIVES We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI). BACKGROUND Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown. METHODS Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion). RESULTS Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p

BACKGROUND The effect of body mass index (BMI) on the procedural outcomes and health status (HS) change after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is largely unknown. METHODS Thousand consecutive patients enrolled in a 12-center prospective CTO PCI study (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures [OPEN-CTO]) were categorized into three groups by baseline BMI (obese ≥30, overweight 25-30, and normal 18.5-25), after excluding seven patients with BMI

Although contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is performed with high success rates, 10% to 13% of patients presenting with CTOs have chronic kidney disease (CKD), and the comparative safety, efficacy, and health status benefit of CTO PCI in these patients, has not been well defined. We examined the association of baseline renal function with periprocedural major adverse cardiovascular and cerebral events and health status outcomes in 957 consecutive patients (mean age 65.3 ± 10.3 years, 19.4% women, 90.3% white, 23.6 CKD [estimated glomerular filtration rate {eGFR}60]) in the OPEN-CTO (Outcomes, Patients Health Status, and Efficiency in Chronic Total Occlusions Registry) study. Hierarchical multivariable regression models were used to examine the independent association of baseline eGFR with technical success, periprocedural complications and change in health status, using Seattle Angina Questionnaire (SAQ) over 1 year. Crude rates of acute kidney injury were higher (13.5% vs 4.4%, p0.001) and technical success lower (81.8% vs 88.4%, p = 0.01) in patients with CKD. There were no significant differences in other periprocedural complications. After adjustment for confounding factors, there was no significant association of baseline eGFR with technical success or periprocedural major adverse cardiovascular and cerebral events (death, myocardial infarction, emergent bypass surgery, stroke, perforation), whereas patients with lower eGFR had higher rates of acute kidney injury. The difference in SAQ summary score, between patients on the 10th and 90th percentile for baseline eGFR distribution was not clinically significant (1 month: -0.91; 1 year: -3.06 points). In conclusion, CTO PCI success, complication rates, and the health status improvement after CTO PCI are similar in patients across a range of baseline eGFRs.

Background Successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can markedly reduce angina symptom burden, but many patients often remain on multiple antianginal medications (AAMs) after the procedure. It is unclear when, or if, AAMs can be de-escalated to prevent adverse effects or limit polypharmacy. We examined the association of de-escalation of AAMs after CTO PCI with long-term health status. Methods In a 12-center registry of consecutive CTO PCI patients, health status was assessed at 6 months after successful CTO PCI with the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Among patients with technical CTO PCI success, we examined the association of AAM de-escalation with 6-month health status using multivariable models adjusting for revascularization completeness and predicted risk of post-PCI angina (using a validated risk model). We also examined predictors and variability of AAMs de-escalation. Results Of 669 patients with technical success of CTO PCI, AAMs were de-escalated in 276 (35.9%) patients at 1 month. Patients with AAM de-escalation reported similar angina and dyspnea rates at 6 months compared with those whose AAMs were reduced (any angina: 22.5% vs 20%, P = .43; any dyspnea: 51.8% vs 50.1%, P = .40). In a multivariable model adjusting for complete revascularization and predicted risk of post-PCI angina, de-escalation of AAMs at 1 month was not associated with an increased risk of angina, dyspnea, or worse health status at 6 months. Conclusions Among patients with successful CTO PCI, de-escalation of AAMs occurred in about one-third of patients at 1 month and was not associated with worse long-term health status.

Objectives This study sought to examine depression prevalence among chronic total occlusion (CTO) patients and compared symptom improvement among depressed and nondepressed patients after percutaneous coronary intervention (PCI). Background Depression in cardiovascular patients is common, but its prevalence among CTO patients and its association with PCI response is understudied. Methods Among 811 patients from the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated change in health status between baseline and 1-year post-PCI, as measured by the Seattle Angina Questionnaire (SAQ) and the Rose Dyspnea Score. Depression was defined using the Personal Health Questionnaire-8. The independent association between health status and depression following PCI was assessed using multivariable regression. Results Among the 811 patients, 190 (23%) screened positive for major depression, of whom 6.3% were on antidepressant therapy at intervention. Depressed patients experienced more baseline angina, but by 1-year post-PCI they experienced greater improvements than nondepressed patients (change in SAQ Summary: 31.4 ± 22.4 vs. 24.2 ± 20.0; p Conclusions Depression is common among CTO PCI patients, but few were treated with antidepressants at baseline. Depressed patients had more severe baseline angina and significant improvement in health status after PCI. (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion [OPEN-CTO]; NCT02026466)

Aims Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has been shown to reduce angina and improve quality of life, but the frequency of new or residual angina after CTO PCI and its relationship with titration of anti-anginal medications (AAMs) has not been described. Methods and results Among consecutive CTO PCI patients treated at 12 US centres in the OPEN CTO registry, angina was assessed 6 months after the index PCI using the Seattle Angina Questionnaire (SAQ) Angina Frequency scale (a score Conclusions One in five patients reported angina 6 months after CTO PCI. Although patients with new or residual angina were more likely to have escalation of AAMs in follow-up compared with those without residual symptoms, only one in four patients with residual angina had escalation of AAMs. Although it is unclear whether this finding reflects maximal tolerated therapy at baseline or therapeutic inertia, these findings suggest an important potential opportunity to further improve symptom control in patients with complex stable ischaemic heart disease.

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.

BACKGROUND Patients with coronary chronic total occlusions (CTO) often have multivessel coronary artery disease. We utilized the OPEN CTO study to evaluate patients who underwent single-vessel versus multivessel percutaneous coronary intervention (PCI) during CTO PCI. METHODS Patients were considered to have undergone single-vessel CTO PCI if they underwent target-vessel only CTO PCI. Patients who underwent multivessel PCI during their index CTO PCI procedure were considered to have undergone multivessel PCI. The additional lesions treated in the multivessel group could be either a separate CTO lesion in a separate epicardial vessel or PCI attempt of any non-CTO stenosis during the same index procedure. Multivariate regression models were used to evaluate predictors of technical success, in-hospital major adverse cardiac and cerebrovascular events (MACCE), and health status measures. RESULTS Eighty hundred twenty-one patients underwent single-vessel CTO PCI and 179 (17.9%) underwent multivessel PCI during their CTO PCI procedure. Baseline comorbidities, index CTO lesion complexity, and successful crossing strategies used were similar between the two groups. Total procedural time (142.6 versus 115.9 minutes, P < 0.01) and contrast administered (293.8 versus 255.0 ml, P < 0.01) were increased in the multivessel CTO PCI group. Single-vessel versus multivessel PCI during these cases did not affect the likelihood of achieving technical success [odds ratio (OR) 1.05, 95% confidence interval (CI) 0.63-1.75] nor the risk for MACCE (OR 1.23, 95% CI 0.72-2.11). Quality of life (QOL) metrics were similar between the two groups at baseline and 30-day follow-up. CONCLUSION There were no significant differences in technical success, in-hospital MACCE rates, or QOL metrics at 30-day follow-up for patients who underwent single-vessel versus multivessel PCI during CTO PCI.

Background No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI). Methods In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed. Results Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI. Conclusion CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.

No previous reports have described the comprehensive care pathways involved in chronic total occlusion percutaneous coronary intervention (CTO PCI).In a study of 1,000 consecutive patients undergoing CTO PCI using hybrid approach, a systematic algorithm of selecting CTO PCI strategies, the procedural characteristics, complication rates, and patient reported health status outcomes through 12 months were assessed.Technical success of the index CTO PCI was 86%, with 89% of patients having at least one successful CTO PCI within 12 months. A total of 13.8% underwent CTO PCI of another vessel or reattempt of index CTO PCI within 1 year. At 1 year, the unadjusted major adverse cardiac and cerebral event (MACCE) rate was lower in patients with successful index CTO PCI compared to patients with unsuccessful index CTO PCI (9.4% vs. 14.6%, p = .04). The adjusted hazard ratios of myocardial infarction and death at 12 months were numerically lower in patients with successful index CTO PCI, compared to patients with unsuccessful index CTO PCI. Patients with successful index CTO PCI reported significantly greater improvement in health status throughout 12-months compared to patients with unsuccessful index CTO PCI.CTO-PCI in the real-world often require treatment of second CTO, non-CTO PCI or repeat procedures to treat initially unsuccessful lesions. Successful CTO PCI is associated with numerically lower MACCE at 1 year and persistent symptomatic improvement compared to unsuccessful CTO PCI. Understanding the relationship between the care pathways following CTO PCI and health status benefit requires further study.

Background: The American College of Cardiology/American Heart Association Appropriate Use Criteria were designed to aid clinical decision-making, yet their association with health status outcomes after chronic total occlusion percutaneous coronary intervention (PCI) is unknown. Methods: We analyzed 769 patients with baseline and 1-year health status data after chronic total occlusion PCI. Procedures were categorized as appropriate, may be appropriate, or rarely appropriate. Mean changes in patient-reported health status, assessed by the Seattle Angina Questionnaire (SAQ), were compared across appropriate use criteria categories from baseline to 1 year. Change in SAQ summary score was stratified as little to no benefit (≤10 points), intermediate (10–19 points), large (20–29 points), and very large (≥30 points). Results: The appropriate use criteria indication was appropriate in 573 patients (74.5%), may be appropriate in 191 (24.8%), and rarely appropriate in 5 (0.7%). Patients in the appropriate group reported greater improvement in SAQ summary scores (27.3±21.3 points) at 1 year compared with the may be appropriate (22.5±20.9; P =0.01). A similar pattern was noted for SAQ angina frequency (mean change 24.0±27.2 versus 18.7±25.6; P =0.02). The appropriate group had the highest proportion of very large improvements in SAQ summary scores (44.5% versus 33.3%; P =0.01). Conclusions: Among patients undergoing chronic total occlusion PCI, the rate of rarely appropriate PCI was low. The rate of appropriate PCI was high and was associated with the greatest health status improvement at 1 year. A substantial proportion of patients in the may be appropriate group experienced meaningful health status benefits as well.

Objectives This study sought to describe the association between chronic total occlusion (CTO) revascularization (CTO percutaneous coronary intervention [PCI]) and health status in patients with and without cardiomyopathy. Background Prior PCI trials for cardiomyopathy have excluded CTO patients. Whether patients with reduced left ventricular ejection fraction (LVEF) receive similar health status benefit from CTO-PCI compared with patients with normal LVEF is unclear. Methods We assessed health status change, using the Seattle Angina Questionnaire (SAQ) Summary, SAQ Angina Frequency, and Rose Dyspnea Scale scores, among patients undergoing successful CTO PCI in the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion) Registry. Participants were classified by LVEF (normal, ≥50%; mild-moderate, 30% to 49%; and severe, Results Of 762 patients, 506 (66.4%), 193 (25.3%), and 63 (8.3%) had normal, mild-moderate, and severely reduced LVEF. SAQ Summary score improvements were observed in each group (27.1 ± 20.4, 26.7 ± 21.2, and 20.3 ± 18.1, respectively). Compared with patients with LVEF ≥50%, those with LVEF Conclusions Although health status improvement was less in patients with severely reduced LVEF compared with those with normal LVEF, each group experienced large health status improvements after CTO-PCI.

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.

Objectives Few studies have evaluated the relationship of diabetes with technical success and periprocedural complications, and no studies have compared patient-reported health status after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in patients with and without diabetes. Background CTOs are more common in patients with diabetes, yet CTO PCI is less often attempted in patients with diabetes than in patients without. The association between diabetes and health status after CTO PCI is unknown. Methods In the 12-center OPEN-CTO PCI registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Registry), patients with and without diabetes were assessed for technical success, periprocedural complications, and health status over 1 year following CTO PCI using the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Hierarchical modified Poisson regression was used to examine the independent association between diabetes and technical success, and hierarchical multivariable linear regression was used to assess the association between diabetes and follow-up health status. Results Diabetes was common (41.2%) and associated with a lower crude rate of technical success (83.5% vs. 88.1%; p = 0.04). After adjustment, there was no significant difference between diabetic and nondiabetic patients (relative risk: 0.96, 95% confidence interval: 0.91 to 1.01). There were no significant differences in complication rates between patients with and without diabetes. Angina burden, quality of life, and overall health status scores were similar between diabetic and nondiabetic patients over 1 year. Conclusions Although technical success was lower in patients with diabetes, this reflected lower success among patients with prior bypass surgery, without any significant difference in success rate after adjusting for prior bypass and disease complexity. CTO PCI complication rates are similar in diabetic and nondiabetic patients, and symptom improvement following CTO PCI is robust and of a similar magnitude regardless of diabetes status.

Objectives We sought to determine the impact of subintimal plaque modification (SPM) on early health status following unsuccessful chronic total occlusion (CTO) PCI. Background Intentionally dilating the subintimal space during unsuccessful CTO PCI to facilitate flow through dissection planes and improve success of repeat PCI attempts is a technique used by some hybrid operators, and may improve health status by restoring distal vessel flow despite unsuccessful CTO PCI. Methods We studied 138 patients who underwent unsuccessful CTO PCI in a 12-center CTO PCI registry. Safety was assessed by comparing in-hospital outcomes of patients undergoing unsuccessful CTO PCI with and without SPM. The association between SPM and health status was quantified using the Seattle Angina Questionnaire Summary Score (SAQ SS), and the association between SPM and SAQ SS was determined using multivariable regression. Results SPM was performed in 59 patients (42.8%). Complication rates were similar comparing those with and without SPM. At 1-month, patients treated with SPM had larger increases in SAQ SS compared to patients who were not (28.3 ± 21.7 vs. 16.8 ±20.2, P = 0.012), and SPM was associated with an adjusted mean 10.5 point (95% CI 1.4-19.7, P = 0.02) greater SAQ SS improvement through 30 days. Conclusion SPM was performed in almost half of unsuccessful CTO PCIs and was not associated with increased procedural complications. SPM was independently associated with better patient-reported health status at 30 days. Further studies are needed to assess the necessity of subsequent PCI in patients with significant health status improvements after SPM.

Objectives This study sought to accurately describe the success rate, risks, and patient-reported benefits of contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background In light of the evolving techniques to successfully revascularize CTO lesions, there remains a compelling need to more accurately quantify the success rates, risks, and benefits of these complex procedures. Methods Using a uniquely comprehensive, core-lab adjudicated, single-arm, multicenter registry of 1,000 consecutive patients undergoing CTO PCI by the hybrid approach, we evaluated the technical success rates, complication rates, and raw and adjusted health status benefits at 1 month among successfully as compared to unsuccessfully treated patients. Results Technical success was high (86%). In-hospital and 1-month mortality was 0.9% and 1.3%, respectively, and perforations requiring treatment occurred in 48 patients (4.8%). Among those who survived and completed the 1-month interview (n = 947), mean ± SEM Seattle Angina Questionnaire quality of life scores improved from 49.4 ± 0.9 to 75.0 ± 0.7 (p Conclusions Clarifying the success rates, risks, and benefits of CTO PCI will help to more accurately contextualize the informed consent process for these procedures so that patients with appropriate indications for CTO PCI can more effectively share in the decision to pursue this or other therapeutic options.

Objectives This study evaluated the usability and contrast volume savings of the novel DyeVert™ System. Background During coronary diagnostic and interventional procedures, a substantial portion of injected contrast does not contribute to vessel imaging due to reflux into the ascending aorta. Contrast volume is the primary physician modifiable risk factor for prevention of contrast-induced acute kidney injury CI-AKI which is a frequent complication in patients undergoing coronary angiographic procedures and is related to increases in morbidity, mortality, and healthcare costs. Methods In this pilot trial, 44 patients undergoing coronary diagnostic and/or percutaneous coronary intervention (PCI) procedures were enrolled in two centers. All procedures were conducted using a manual manifold injection setup and the DyeVert System, which facilitates the diversion of excess contrast volume prior to injection into the patient. Direct measurements of both the amount of contrast that was attempted to be injected and the actual volume injected into the patient were taken. Results The difference between the two amounts indicated the volume saved. Procedure types included 34 diagnostic studies and 10 PCI. The mean percent volume saved by the DyeVert System was 47%, with a corresponding P value of

Forty years since Andreas Gruentzig performed the first percutaneous coronary intervention (PCI), the rationale for revascularisation in stable coronary artery disease (CAD) continues to evolve. The cardiology community has shifted from revascularisation of all anatomically obstructive lesions towards deferring and medically managing stenoses with preserved flow as measured by fractional flow reserve (FFR). Clinical trials have established the role of FFR in contemporary therapeutic decision making, with FFR-guided revascularisation associated with a reduction in the incidence of myocardial infarction, improved angina relief compared with optimal medical therapy (OMT) and reduced healthcare costs.1 2 ​Decision making in modern medicine is often driven by binary cut-offs, a strategy that has both strengths and limitations. On one hand, a binary cut-off can facilitate decision making and ease of interpretation, and therefore encourages the use of intracoronary physiology in clinical practice. In contrast, the use of a rigid cut-off does not account for the biological and measurement variability of FFR, thereby introducing a degree of inaccuracy around the diagnostic threshold. Initially an FFR value of 99% positive predictive value for inducible myocardial ischaemia across multiple non-invasive modalities.3 4 Given the observation that in a small proportion of lesions an FFR between 0.75 and 0.80 was associated with flow-limiting stenosis, the FFR threshold to guide revascularisation in the FAME trials was increased to 0.80 to improve its sensitivity in detecting ischaemia at the cost of specificity.2 Accordingly, an FFR grey zone for values between 0.75 and 0.80 was recommended in which decision making should be based on clinical judgement and the presence of additional information.1 Yet using binary cut-off values in interpreting FFR goes beyond diagnostic accuracy and has implications for its prognostic value. Previous …

Background: Prior research has shown that providers may infrequently adjust antianginal medications (AAMs) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Patient characteristics associated with AAM titration and the variation in postprocedure AAM management after CTO PCI across hospitals have not been reported. We sought to determine the frequency and potential correlates of AAM escalation and de-escalation after CTO PCI. Methods and Results: Using the 12-center OPEN CTO registry (Outcomes, Patient Health Status, and Efficiency iN Chronic Total Occlusion Hybrid Procedures), we assessed AAM use at baseline and 6 months after CTO PCI. Escalation was defined as any addition of a new class of AAM or dose increase, whereas de-escalation was defined as a reduction in the number of AAMs or dose reduction. Angina was assessed 6 months after the index CTO PCI attempt using the Seattle Angina Questionnaire Angina Frequency domain. Potential correlates of AAM escalation (vs no change) or de-escalation (vs no change) were evaluated using multivariable modified Poisson regression models. Adjusted variation across sites was evaluated using median rate ratios. AAMs were escalated in 158 (17.5%), de-escalated in 351 (39.0%), and were unchanged at 6-month follow-up in 392 (43.5%). Patient characteristics associated with escalation included lung disease, ongoing angina, and periprocedural major adverse cardiac and cerebral events (periprocedural myocardial infarction, stroke, death, emergent cardiac surgery, or clinically significant perforation), whereas de-escalation was more frequent among patients taking more AAMs, those treated with complete revascularization, and after treatment of non-CTO lesions at the time of the index procedure. There was minimal variation in either escalation (median rate ratio, 1.11; P =0.36) or de-escalation (median rate ratio, 1.10; P =0.20) compared to no change of AAMs across sites. Conclusions: Escalation or de-escalation of AAMs was less common than continuation following CTO PCI, with little variation across sites. Further research is needed to identify patients who may benefit from AAM titration after CTO PCI and develop strategies to adjust these medications in follow-up. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02026466.

Background: Health status and quality of life improvement after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) among patients with refractory angina has not been reported. We sought to determine the degree of quality of life improvement after CTO PCI in patients with refractory angina. Methods and Results: Among 1000 consecutive patients who underwent CTO PCI in a 12-center registry, refractory angina was defined as any angina (baseline Seattle Angina Questionnaire [SAQ] Angina Frequency score of ≤90) despite treatment with ≥3 antianginal medications. Health status at baseline and 1-year follow-up was quantified using the SAQ. Refractory angina was present at baseline in 148 patients (14.8%). Technical success was achieved in 120 (81.1%) at the initial attempt and major adverse cardiac and cerebral events occurred in 10 (6.8%). There were no procedural deaths. Refractory angina patients were highly symptomatic at baseline with mean SAQ Angina Frequency of 51.1±23.8, SAQ quality of life of 35.3±21.2, and SAQ Summary Score of 47.2±17.9, improving by 32.0±27.8, 35.7±23.9, and 32.1±20.1 at 1 year. Through 1-year follow-up, patients with successful CTO PCI had significantly larger degree of improvement of SAQ Angina Frequency and SAQ Summary Score (35.0±26.8 versus 18.8±28.9, P P Conclusions: Refractory angina was present in 1 of 7 patients in the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry. Patients with refractory angina experienced large, clinically significant health status improvements that persisted through 12 months, and patients with successful CTO PCI had larger health status improvement than those without.

Objectives This study sought to describe the angiographic characteristics, strategy associated with perforation, and the management of perforation during chronic total occlusion percutaneous coronary intervention (CTO PCI). Background The incidence of perforation is higher during CTO PCI compared with non-CTO PCI and is reportedly highest among retrograde procedures. Methods Among 1,000 consecutive patients who underwent CTO PCI in a 12-center registry, 89 (8.9%) had core lab–adjudicated angiographic perforations. Clinical perforation was defined as any perforation requiring treatment. Major adverse cardiac events (MAEs) were defined as in-hospital death, cardiac tamponade, and pericardial effusion. Results Among the 89 perforations, 43 (48.3%) were clinically significant, and 46 (51.7%) were simply observed. MAE occurred in 25 (28.0%), and in-hospital death occurred in 9 (10.1%). Compared with nonclinical perforations, clinical perforations were larger in size, more often at a collateral location, had a high-risk shape, and less likely to cause staining or fast filling. Compared with perforations not associated with MAE, perforations associated with MAE were larger in size, more proximal or at collateral location, and had a high-risk shape. When the core lab attributed the perforation to the approach used when the perforation occurred, 61% of retrograde perforations by other classifications were actually antegrade. Conclusions Larger size, proximal or collateral location, and high-risk shapes of a coronary perforation were associated with MAE. Six of 10 perforations occurred with antegrade approaches among patients who had both strategies attempted. These finding will help emerging CTO operators understand high-risk features of the perforation that require treatment and inform future comparisons of retrograde and antegrade complications.

The association between body mass index (BMI) and health status (HS) outcomes after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) are unknown. 1000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN-CTO) were categorized into 3 groups by baseline BMI

Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality. Among 1000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were

This study sought to examine depression prevalence among chronic total occlusion (CTO) patients and compared symptom improvement among depressed and nondepressed patients after percutaneous coronary intervention (PCI).Depression in cardiovascular patients is common, but its prevalence among CTO patients and its association with PCI response is understudied.Among 811 patients from the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated change in health status between baseline and 1-year post-PCI, as measured by the Seattle Angina Questionnaire (SAQ) and the Rose Dyspnea Score. Depression was defined using the Personal Health Questionnaire-8. The independent association between health status and depression following PCI was assessed using multivariable regression.Among the 811 patients, 190 (23%) screened positive for major depression, of whom 6.3% were on antidepressant therapy at intervention. Depressed patients experienced more baseline angina, but by 1-year post-PCI they experienced greater improvements than nondepressed patients (change in SAQ Summary: 31.4 ± 22.4 vs. 24.2 ± 20.0; p 0.001). After adjustment, baseline depressed patients had more improvement in health status (adjusted difference in SAQ Summary improvement, depressed vs. nondepressed: 5.48 ± 1.81; p = 0.003).Depression is common among CTO PCI patients, but few were treated with antidepressants at baseline. Depressed patients had more severe baseline angina and significant improvement in health status after PCI. (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion [OPEN-CTO]; NCT02026466).

Introduction Women have been under-represented in trials. Due to the dearth of information about CTO-PCI in women and discordance of previous results, sex differences in outcomes in the OPEN-CTO Trial were investigated. Methods OPEN-CTO is an investigator-initiated, multicenter, prospective observational registry of consecutive CTO patients undergoing PCI at 12 U.S. centers. The one-year outcomes of this trial stratified by sex were examined. Optimal propensity matching was performed to compare outcomes between sexes. Multivariate conditional logistic regression modeling for predictors of procedural success was performed. Results Women represented 19.6% of the cohort (196/1,000 patients). Women were more likely to report dyspnea as their predominant symptom. Women reported statistically worse physical limitation and poorer quality of life as compared to men. J-CTO scores were similar in males and females. Technical, procedural success and MACE rates were similar in both sexes. Contrast and radiation doses were however significantly lower in women. The SAQ- summary score, RDS, EQ-5D VAS, PHQ-8 scores were all improved to the same degree at 1 year in women as compared to men. Predictors of procedural success revealed that younger age, lower J-CTO score and absence of prior CABG were predictors of procedural success. Sex did not predict procedural success or 1-year MACE in this regression model. Conclusion This real-world registry revealed that women derive the same benefit from CTO-PCI as men without additional complications and with favorable health status outcomes at 1 year. Consideration of revascularization by PCI in symptomatic women should be considered as part of the treatment when appropriate.

Aims Contemporary coronary chronic total occlusion (CTO) PCI has been associated with increased success rates. However, the rate of periprocedural complications for hybrid CTO PCI remains incompletely defined. We leveraged the OPEN CTO study in order to describe the prevalence, predictors, and health status outcomes of complications during contemporary CTO PCI. Methods and results Baseline demographics, procedural characteristics and rates of in-hospital complications were prospectively collected for 1,000 consecutive procedures at 12 expert US centres from 02/2014 to 07/2015. Multivariable logistic regression was used to evaluate the association of pre-specified anatomic and physiologic variables with complications. Patient-reported health status measures over the year following CTO PCI were also compared between those with and those without periprocedural complications. The overall complication rate was 9.7% (n=97/1,000). The most common adverse events were perforation (8.8%), periprocedural myocardial infarction (2.6%), arrhythmia requiring treatment (1.2%), cardiogenic shock (1.1%), and in-hospital death (0.9%). Independent predictors of complications during CTO PCI were: use of the retrograde approach (OR 1.98, 95% CI: 1.32-2.99), age (OR 1.30, 95% CI: 1.07-1.58 per 10-year increment), and J-CTO score (OR 1.20, 95% CI: 1.03-1.41 per one point increment). Mean health status scores over 12 months were worse for patients who experienced complications compared to those who did not, even after adjusting for baseline health status. Conclusions Complication rates for CTO PCI are more frequent than those reported for non-CTO PCI and were independently associated with retrograde approach, increasing age, and increasing lesion complexity. In addition, these periprocedural complications were also associated with worse long-term health status outcomes.

The objective of the study was to report clinical outcomes of patients unsuitable for surgical coronary revascularization (CABG) treated with percutaneous revascularization (PCI) or medical therapy alone (MT). The decision to revascularize patients referred for CABG but who are unsuitable should be made at Heart Team meetings. The clinical outcomes in this important patient subset are not known, and while cases are considered individually, these decisions are not guided by robust data. Clinical data were analyzed for patients referred to the Heart Team for consideration of CABG over a 4-year period in a UK tertiary referral center. Outcome data for those managed with urgent PCI or MT were considered over a further 3-year period. 133 patients were treated with PCI and 117 with MT. MACE at 30 days were no different between groups (MT 10.3% versus PCI 12.2%); however, at 1 year MACE were higher in the MT group (MT 39.3% versus PCI 26.7%, P

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).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.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.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.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.

Background: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) effectively reduces angina symptoms and improves quality of life, but the frequency of new or residual angina (RA) in follow-up after CTO PCI and its relationship with titration of anti-anginal medications (AAM) has not been described. Methods: In consecutive CTO PCI patients treated at 12 centers in the OPEN CTO registry, angina symptoms were assessed 6 months after the index PCI using the Seattle Angina Questionnaire (SAQ) Angina Frequency scale (a score Results: Of 901 patients undergoing CTO PCI, 197 (21.9%) reported angina at 6-months. Of patients with RA, 54 (27.4%) had de-escalation, 118 (59.9%) had no change, and 25 (12.7%) had escalation of their AAM by 6 month follow-up. Although patients with residual angina were more likely to have escalation of AAMs, only 12.7% of patients with residual angina had escalation of their AAM regimens in follow-up. Results were similar when stratifying patients by the ultimate success of the CTO PCI, completeness of physiologic revascularization, and presence or absence of angina at baseline (Figure). Conclusions: One in 5 patients reported angina 6-months after CTO PCI. Although patients with new or residual angina were more likely to have escalation of AAMs in follow-up compared to those without residual symptoms, only one in 7 patients with residual angina had escalation of AAMs. These results were similar in key subgroups. Although it is unclear whether this finding reflects maximal tolerated therapy at baseline or therapeutic inertia, these findings suggest an important potential opportunity to further improve symptom control in complex stable ischemic heart disease.

Background The hybrid approach to chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has significantly increased procedural success rates, yet some cases still fail. We sought to evaluate the causes of failure in a contemporary CTO PCI registry. Methods We examined 380 consecutive patients who underwent CTO-PCI at 4 high volume CTO PCI centers in the United States using the “hybrid” approach. Clinical, angiographic, complication, and efficiency outcomes were compared between successful and failed cases. Failed cases were individually reviewed by an independent reviewer to determine the cause of failure. Results Procedural success was 91.3%. Compared with patients in whom CTO PCI was successful, those in whom CTO PCI failed had similar baseline clinical characteristics, but were more likely to have longer occlusion length, more tortuosity, more proximal cap ambiguity and blunt stump, and higher mean J-CTO scores (2.8 ± 1.1 vs. 3.5 ± 1.0, P

Background— Dyspnea is a common angina equivalent that adversely affects quality of life, but its prevalence in patients with chronic total occlusions (CTOs) and predictors of its improvement after CTO percutaneous coronary intervention (PCI) are unknown. We examined the prevalence of dyspnea and predictors of its improvement among patients selected for CTO PCI. Methods and Results— In the OPEN CTO registry (Outcomes, Patient health status, and Efficiency iN Chronic Total Occlusion) of 12 US experienced centers, 987 patients undergoing CTO PCI (procedure success 82%) were assessed for dyspnea with the Rose Dyspnea Scale at baseline and 1 month after CTO PCI. Rose Dyspnea Scale scores range from 0 to 4 with higher scores indicating more dyspnea with common activities. A total of 800 (81%) reported some dyspnea at baseline with a mean (±SD) Rose Dyspnea Scale of 2.8±1.2. Dyspnea improvement was defined as a ≥1 point decrease in Rose Dyspnea Scale from baseline to 1 month. Predictors of dyspnea improvement were examined with a modified Poisson regression model. Patients with dyspnea were more likely to be female, obese, smokers, and to have more comorbidities and angina. Among patients with baseline dyspnea, 70% reported less dyspnea at 1 month after CTO PCI. Successful CTO PCI was associated with more frequent dyspnea improvement than failure, even after adjustment for other clinical variables. Anemia, depression, and lung disease were associated with less dyspnea improvement after PCI. Conclusions— Dyspnea is a common symptom among patients undergoing CTO PCI and improves significantly with successful PCI. Patients with other potentially noncardiac causes of dyspnea reported less dyspnea improvement after CTO PCI.

Few studies have evaluated the relationship of diabetes with technical success and periprocedural complications, and no studies have compared patient-reported health status after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in patients with and without diabetes.CTOs are more common in patients with diabetes, yet CTO PCI is less often attempted in patients with diabetes than in patients without. The association between diabetes and health status after CTO PCI is unknown.In the 12-center OPEN-CTO PCI registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Registry), patients with and without diabetes were assessed for technical success, periprocedural complications, and health status over 1 year following CTO PCI using the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Hierarchical modified Poisson regression was used to examine the independent association between diabetes and technical success, and hierarchical multivariable linear regression was used to assess the association between diabetes and follow-up health status.Diabetes was common (41.2%) and associated with a lower crude rate of technical success (83.5% vs. 88.1%; p = 0.04). After adjustment, there was no significant difference between diabetic and nondiabetic patients (relative risk: 0.96, 95% confidence interval: 0.91 to 1.01). There were no significant differences in complication rates between patients with and without diabetes. Angina burden, quality of life, and overall health status scores were similar between diabetic and nondiabetic patients over 1 year.Although technical success was lower in patients with diabetes, this reflected lower success among patients with prior bypass surgery, without any significant difference in success rate after adjusting for prior bypass and disease complexity. CTO PCI complication rates are similar in diabetic and nondiabetic patients, and symptom improvement following CTO PCI is robust and of a similar magnitude regardless of diabetes status.

This study sought to accurately describe the success rate, risks, and patient-reported benefits of contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI).In light of the evolving techniques to successfully revascularize CTO lesions, there remains a compelling need to more accurately quantify the success rates, risks, and benefits of these complex procedures.Using a uniquely comprehensive, core-lab adjudicated, single-arm, multicenter registry of 1,000 consecutive patients undergoing CTO PCI by the hybrid approach, we evaluated the technical success rates, complication rates, and raw and adjusted health status benefits at 1 month among successfully as compared to unsuccessfully treated patients.Technical success was high (86%). In-hospital and 1-month mortality was 0.9% and 1.3%, respectively, and perforations requiring treatment occurred in 48 patients (4.8%). Among those who survived and completed the 1-month interview (n = 947), mean ± SEM Seattle Angina Questionnaire quality of life scores improved from 49.4 ± 0.9 to 75.0 ± 0.7 (p 0.01), mean Rose Dyspnea Scale scores improved (decreased) from 2.0 ± 0.1 to 1.1 ± 0.1 (p 0.01), and physician health questionnaire (for depression) scores improved (decreased) from 6.2 ± 0.2 to 3.5 ± 0.1 (p 0.01) at 1 month. After adjusting for baseline differences the mean group difference in Seattle Angina Questionnaire quality of life between successful and unsuccessful CTO PCI was 10.8 (95% confidence interval: 6.3 to 15.3; p 0.001).Clarifying the success rates, risks, and benefits of CTO PCI will help to more accurately contextualize the informed consent process for these procedures so that patients with appropriate indications for CTO PCI can more effectively share in the decision to pursue this or other therapeutic options.

Technical advances and the development of the Hybrid algorithm have been associated with higher success rates in chronic total occlusion percutaneous coronary intervention (CTO-PCI). Nevertheless, there are still intraprocedural obstacles that result in failure or prolonged procedure time. The Excimer coronary laser (EL) has been repurposed in CTO-PCI to overcome such obstacles. This case series illustrates the use of the EL in four technically complex scenarios including the balloon resistant lesion, the impenetrable proximal cap, device resistance in stent restenosis, and difficulty with device tracking in the subintima. © 2014 Wiley Periodicals, Inc.

Chronic total occlusion percutaneous intervention (CTO-PCI) technique has evolved coincident with improvements in success rate and safety of the procedure. Despite this, many patients are not offered this treatment even after medical therapy fails to alleviate their symptoms. The frequently stated reasons for this include the absence of randomized trial data, excessive costs and the time burden of the procedures. In this article our aim is to dispel the myths surrounding the benefits, costs and time burden of CTO-PCI and suggest that these excuses for not attempting CTO-PCI should be avoided so that patients receive the treatment they need, not simply the treatment their provider or institution prefers.

Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality. The retrograde approach has been reported to have higher complication rates than the antegrade approach. However, these

Chronic total occlusion percutaneous intervention is becoming a more common technique with higher success rates. These success rates can be at least partially attributed to the use of classical and contemporary imaging modalities. Preprocedural preparation including patient selection and detailed coronary imaging with the use of computerized tomography are helpful to ensure the highest chance of success. Procedural utilization of intravascular ultrasound and optical coherence tomography are additional tools to help facilitate success during difficult cases. Minimally invasive imaging modalities help determine improvement of left ventricular function or the presence of continued ischemia in the postprocedural period. Newer techniques including high-definition computerized tomography scanners can accurately show details of stent morphology and the presence of in-stent restenosis without the need of a further procedure. Invasive imaging including the use of intravascular ultrasound and optical coherence tomo...

This study evaluated the usability and contrast volume savings of the novel DyeVert™ System.During coronary diagnostic and interventional procedures, a substantial portion of injected contrast does not contribute to vessel imaging due to reflux into the ascending aorta. Contrast volume is the primary physician modifiable risk factor for prevention of contrast-induced acute kidney injury CI-AKI which is a frequent complication in patients undergoing coronary angiographic procedures and is related to increases in morbidity, mortality, and healthcare costs.In this pilot trial, 44 patients undergoing coronary diagnostic and/or percutaneous coronary intervention (PCI) procedures were enrolled in two centers. All procedures were conducted using a manual manifold injection setup and the DyeVert System, which facilitates the diversion of excess contrast volume prior to injection into the patient. Direct measurements of both the amount of contrast that was attempted to be injected and the actual volume injected into the patient were taken.The difference between the two amounts indicated the volume saved. Procedure types included 34 diagnostic studies and 10 PCI. The mean percent volume saved by the DyeVert System was 47%, with a corresponding P value of0.0001 achieving the pre-specified level of greater than 15% of contrast media being saved. Mean volume savings were similar for both diagnostic (47 ± 9%) and PCI (50 ± 9%) procedures. Image quality was good in 43/44 (98%) patients.The DyeVert System substantially decreases contrast delivered to patients during diagnostic or interventional coronary procedures while maintaining adequate image quality. © 2017 Wiley Periodicals, Inc.

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.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.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.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.

Clinical and angiographic features in CTO PCI predict procedural difficulty, success, and outcomes. The Japanese CTO (JCTO) score, though widely used, has not consistently predicted success in CTO PCI (validation area under the curve (AUC) 0.76). The PROGRESS CTO score was derived and tested in the