A sex stratified outcome analysis from the OPEN-CTO registry.

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.

Hospital-Level Variability in Use of Intracoronary Imaging for Percutaneous Coronary Intervention in the United States.

Background: Intracoronary (IC) imaging for percutaneous coronary intervention (PCI) is associated with better patient outcomes and carries a class IIA guideline recommendation, but it remains rarely used. We sought to characterize hospital-level variability in IC imaging for PCI in the United States and to identify factors that may explain this variability. Methods: Patients who underwent PCI, with or without IC imaging, in the Nationwide Readmissions Database (2016-2020) were included. A regression model with a random effect for site was used to generate the median odds ratio (MOR) of IC imaging use for a patient at one site vs another, sequentially adjusting for procedural, patient, and hospital factors to examine the extent to which different factors account for this variability. Results: The analytic cohort included 1,328,517 PCI procedures (patient mean age 65.8 years, 32.4% female, IC imaging used in 9.2%) at 1068 hospitals. The median hospital use of IC imaging increased from 2.7% (IQR, 0.6-7.7) in 2016 to 6.3% (IQR, 1.7-17.8) in 2020. In 2020, the MOR for IC imaging during PCI was 4.6 (IQR, 4.3-5.0), indicating a >4-fold difference in the odds of a patient undergoing IC imaging with PCI at one random hospital vs another. Adjusting for procedure, patient, and hospital factors did not meaningfully alter the MOR. Conclusion: The average US hospital uses IC imaging for <1 in 15 PCI procedures, with marked variability across hospitals. Strategies to increase and standardize the use of IC imaging are needed to improve the quality of PCI in the United States.

Association of Successful Percutaneous Revascularization of Chronic Total Occlusions With Quality of Life: A Systematic Review and Meta-Analysis.

Importance: Chronic total occlusion percutaneous coronary intervention (CTO-PCI) is not usually offered because of skepticism about long-term clinical benefits. Objective: To assess the association of successful CTO-PCI with quality of life by analyzing the relevant domains of the Seattle Angina Questionnaire (SAQ). Data Sources: PubMed, EMBASE, Web of Science, Google Scholar, and Cochrane databases were searched to identify randomized trials and observational studies specifically addressing quality of life domains of SAQ from January 2010 to June 2022. Study Selection: Studies included reporting SAQ metrics such as angina frequency, physical limitation, and quality of life, before and after CTO-PCI. Data Extraction and Synthesis: The present study was performed according to the Cochrane Collaboration and Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements, in which fixed-effect or random-effect models with generic inverse-variance weighting depending on statistical homogeneity were applied. Data were extracted by 3 independent reviewers. Outcomes and Measures: The primary outcome was angina frequency; physical limitation and quality of life were assessed as secondary outcomes. Results: Seven prospective randomized or observational studies (2500 patients) were included, with a mean (SD) participant age of 61.2 (2.1) years. CTO-PCI was associated with significantly improved quality-of-life metrics during a mean (SD) follow-up of 14.8 (16.3) months. In patients with successful procedures, angina episodes became less frequent (mean [SD] difference for SAQ angina frequency of 12.9 [3.1] survey points [95% CI, 7.1-19.8 survey points]; standardized mean difference was 0.54 [95% CI, 0.21-0.92]; P = .002; I2 = 86.4%) and they experienced less physical activity limitation (mean [SD] difference for SAQ physical limitation of 9.7 [6.2] survey points [95% CI, 3.5-16.2 survey points]; standardized mean difference was 0.42 [95% CI, 0.24-0.55]; P < .001; I2 = 20.9%), and greater quality-of-life domain (mean [SD] difference for SAQ quality of life of 14.9 [3.5] survey points [95% CI, 7.7-22.5 survey points]; standardized mean difference was 0.41 [95% CI, 0.25-0.61]; P < .001; I2 = 58.8%) compared with patients with optimal medical therapy or failed procedure. Furthermore, follow-up duration (point estimate, 0.03; 95% CI, 0.01-0.04; P = .01) was associated with a significant decrease in angina frequency in meta-regression analysis. Conclusions and Relevance: In this systematic review and meta-analysis examining quality of life following CTO-PCI, successful procedures were associated with improved quality-of-life parameters compared with patients on optimal medical therapy or after failed CTO-PCI. These findings suggest support for using PCI to treat CTOs in symptomatic patients unresponsive to medical treatment.

Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention in Patients With Renal Dysfunction.

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%, p <0.001) 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.

Management of Percutaneous Coronary Intervention Complications: Algorithms From the 2018 and 2019 Seattle Percutaneous Coronary Intervention Complications Conference.

Complications of percutaneous coronary intervention (PCI) may have significant impact on patient survival and healthcare costs. PCI procedural complexity and patient risk are increasing, and operators must be prepared to recognize and treat complications, such as perforations, dissections, hemodynamic collapse, no-reflow, and entrapped equipment. Unfortunately, few resources exist to train operators in PCI complication management. Uncertainty regarding complication management could contribute to the undertreatment of patients with high-complexity coronary disease. We, therefore, coordinated the Learning From Complications: How to Be a Better Interventionalist courses to disseminate the collective experience of high-volume PCI operators with extensive experience in chronic total occlusion and high-risk PCI. From these conferences in 2018 and 2019, we developed algorithms that emphasize early recognition, effective treatment, and team-based care of PCI complications. We think that an algorithmic approach will result in a logical and systematic response to life-threatening complications. This construct may be useful for operators who plan to perform complex PCI procedures.

Examining the Operator Learning Curve for Percutaneous Coronary Intervention of Chronic Total Occlusions.

BACKGROUND: Advances in chronic total occlusion percutaneous coronary intervention (CTO PCI) techniques have led to increased procedural success rates among operators. While utilization of CTO PCI has disseminated widely, the learning curve for new operators has not been well-defined. METHODS: Between July 2009 and December 2015, 93 875 CTO PCI cases were extracted from the CathPCI Registry. We delineated a cohort of new CTO operators performing <10 CTO PCI cases per given year. In-hospital outcomes for subsequent CTO PCIs were stratified by the number of prior cases accrued by each operator. Multivariable regression models were used to estimate differences in outcomes with increasing experience. The primary outcome was major adverse cardiovascular events defined as the composite of death, myocardial infarction, stroke, tamponade, or urgent coronary artery bypass grafting. RESULTS: Among 70 916 cases performed by 7251 new operators, procedure success rate was 61.4% and major adverse cardiovascular event rate was 4.2%. Meanwhile, the rate of major bleeding was 4.0%, myocardial infarction 2.0%, mortality 0.6%, tamponade 0.3%, and renal failure 0.2%. Adjusted regression models demonstrated piecewise linear improvements in guidewire crossing, stent placement, and procedure success with accrued volume, albeit with increased contrast use, fluoroscopy time, and bleeding. Major adverse cardiovascular event rates were stable beyond the 12th case (odds ratio per 5 case increase 1.00; 95% CI, 0.98-1.03, P=0.7980). CONCLUSIONS: Among a large number of new CTO PCI operators in the United States, there exists an experiential learning curve for procedural success. However, there were higher rates of bleeding despite case experience, while major adverse cardiovascular events remained relatively unchanged after initiation.