Angiographic Features and Clinical Outcomes of Balloon Uncrossable Lesions during Chronic Total Occlusion Percutaneous Coronary Intervention.

Background: Balloon uncrossable lesions are defined as lesions that cannot be crossed with a balloon after successful guidewire crossing. Methods: We analyzed the association between balloon uncrossable lesions and procedural outcomes of 8671 chronic total occlusions (CTOs) percutaneous coronary interventions (PCIs) performed between 2012 and 2022 at 41 centers. Results: The prevalence of balloon uncrossable lesions was 9.2%. The mean patient age was 64.2 ± 10 years and 80% were men. Patients with balloon uncrossable lesions were older (67.3 ± 9 vs. 63.9 ± 10, p < 0.001) and more likely to have prior coronary artery bypass graft surgery (40% vs. 25%, p < 0.001) and diabetes mellitus (50% vs. 42%, p < 0.001) compared with patients who had balloon crossable lesions. In-stent restenosis (23% vs. 16%. p < 0.001), moderate/severe calcification (68% vs. 40%, p < 0.001), and moderate/severe proximal vessel tortuosity (36% vs. 25%, p < 0.001) were more common in balloon uncrossable lesions. Procedure time (132 (90, 197) vs. 109 (71, 160) min, p < 0.001) was longer and the air kerma radiation dose (2.55 (1.41, 4.23) vs. 1.97 (1.10, 3.40) min, p < 0.001) was higher in balloon uncrossable lesions, while these lesions displayed lower technical (91% vs. 99%, p < 0.001) and procedural (88% vs. 96%, p < 0.001) success rates and higher major adverse cardiac event (MACE) rates (3.14% vs. 1.49%, p < 0.001). Several techniques were required for balloon uncrossable lesions. Conclusion: In a contemporary, multicenter registry, 9.2% of the successfully crossed CTOs were initially balloon uncrossable. Balloon uncrossable lesions exhibited lower technical and procedural success rates and a higher risk of complications compared with balloon crossable lesions.

External validation of the PROGRESS-CTO complication risk scores: Individual patient data pooled analysis of 3 registries.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with a considerable risk of complications, and risk stratification is of utmost importance. AIMS: To assess the clinical usefulness of the recently developed PROGRESS-CTO (NCT02061436) complication risk scores in an independent cohort. METHODS: Individual patient data pooled analysis of 3 registries was performed. RESULTS: Of the 4569 patients who underwent CTO PCI, 102 (2.2%) had major adverse cardiovascular events (MACE). Patients with MACE were older (69 ± 11 vs. 65 ± 10, p < 0.001), more likely to have a history of prior coronary artery bypass graft surgery, and unfavorable angiographic characteristics J-CTO score (2.4 ± 1.2 vs. 2.1 ± 1.3, p = 0.007), including blunt stump (59% vs. 49%, p = 0.047). Technical success was lower in patients with MACE (59% vs. 86%, p < 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO complication risk models were as follows: MACE 0.72 (95% confidence interval [CI], 0.67-0.76), mortality 0.73 (95% CI, 0.61-0.85), and pericardiocentesis 0.69 (95% CI, 0.62-0.77) in the validation dataset. The observed complication rates increased with higher PROGRESS-CTO complication scores. The PROGRESS-CTO MACE score showed good calibration in this external cohort, with MACE rates similar to the original study: 0.7% (score 0-1), 1.5% (score 2), 2.2% (score 3), 3.8% (score 4), 4.9% (score 5), 5.8% (score 6-7). CONCLUSION: Given the good discriminative performance, calibration, and ease of calculation, the PROGRESS-CTO complication scores could help assess the risk of complications in patients undergoing CTO PCI.

A Systematic Review and Meta-Analysis of Clinical Outcomes of Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention.

OBJECTIVES: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can improve patient symptoms, but it remains controversial whether it impacts subsequent clinical outcomes. METHODS: In this systematic review and meta-analysis, we queried PubMed, ScienceDirect, Cochrane Library, Web of Science, and Embase databases (last search: September 15, 2021). We investigated the impact of CTO-PCI on clinical events including all-cause mortality, cardiovascular death, myocardial infarction (MI), major adverse cardiovascular event (MACE), stroke, subsequent coronary artery bypass surgery, target-vessel revascularization, and heart failure hospitalizations. Pooled analysis was performed using a random-effects model. RESULTS: A total of 58 publications with 54,540 patients were included in this analysis, of which 33 were observational studies of successful vs failed CTO-PCI, 19 were observational studies of CTO-PCI vs no CTO-PCI, and 6 were randomized controlled trials (RCTs). In observational studies, but not RCTs, CTO-PCI was associated with better clinical outcomes. Odds ratios (ORs) and 95% confidence intervals (CIs) for all-cause mortality, MACE, and MI were 0.52 (95% CI, 0.42-0.64), 0.46 (95% CI, 0.37-0.58), 0.66 (95% CI, 0.50-0.86), respectively for successful vs failed CTO-PCI studies; 0.38 (95% CI, 0.31-0.45), 0.57 (95% CI, 0.42-0.78), 0.65 (95% CI, 0.42-0.99), respectively, for observational studies of CTO-PCI vs no CTO-PCI; 0.72 (95% CI, 0.39-1.32), 0.69 (95% CI, 0.38-1.25), and 1.04 (95% CI, 0.46-2.37), respectively for RCTs. CONCLUSIONS: CTO-PCI is associated with better subsequent clinical outcomes in observational studies but not in RCTs. Appropriately powered RCTs are needed to conclusively determine the impact of CTO-PCI on clinical outcomes.

Preprocedural coronary computed tomography angiography in chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: Preprocedural coronary computed tomography angiography (CCTA) can be useful in procedural planning for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical, angiographic and procedural characteristics and outcomes of cases with vs. without preprocedural CCTA in PROGRESS-CTO (NCT02061436). Multivariable logistic regression was used to adjust for confounding factors. RESULTS: Of 7034 CTO PCI cases, preprocedural CCTA was used in 375 (5.3%) with increasing frequency over time. Patients with preprocedural CCTA had a higher prevalence of prior coronary artery bypass graft surgery (39% vs. 27%, p < 0.001) and angiographically unfavorable characteristics including higher prevalence of proximal cap ambiguity (52% vs. 33%, p < 0.001) and moderate/severe calcification (59% vs. 41%, p < 0.001) compared with those without CCTA. CCTA helped resolve proximal cap ambiguity in 27%, identified significant calcium not seen on diagnostic angiography in 18%, changed estimated CTO length by >5 mm in 10%, and was performed as part of initial coronary artery disease work up in 19%. CCTA cases had higher J-CTO (2.6 ± 1.2 vs. 2.3 ± 1.3, p < 0.001) and PROGRESS-CTO (1.3 ± 1.0 vs. 1.2 ± 1.0 p = 0.027) scores. After adjusting for potential confounders, cases with preprocedural CCTA had similar technical success (odds ratio [OR]: 1.18, 95% confidence interval [CI], 0.83-1.67) and incidence of major adverse cardiovascular events (OR: 1.47, 95% CI, 0.72-3.00). CONCLUSION: Preprocedural CCTA was used in ~5% of CTO PCI cases. While CCTA may help with procedural planning, especially in complex cases, technical success and MACE were similar with or without CCTA.

Predicting Periprocedural Complications in Chronic Total Occlusion Percutaneous Coronary Intervention: The PROGRESS-CTO Complication Scores.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with increased risk of periprocedural complications. Estimating the risk of complications facilitates risk-benefit assessment and procedural planning. OBJECTIVES: This study sought to develop risk scores for in-hospital major adverse cardiovascular events (MACE), mortality, pericardiocentesis, and acute myocardial infarction (MI) in patients undergoing CTO PCI. METHODS: The study analyzed the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; NCT02061436) and created risk scores for MACE, mortality, pericardiocentesis, and acute MI. Logistic regression prediction modeling was used to identify independently associated variables, and models were internally validated with bootstrapping. RESULTS: The incidence of periprocedural complications among 10,480 CTO PCIs was as follows: MACE 215 (2.05%), mortality 47 (0.45%), pericardiocentesis 83 (1.08%), and acute MI 66 (0.63%). The final model for MACE included ≥65 years of age (1 point), moderate-severe calcification (1 point), blunt stump (1 point), antegrade dissection and re-entry (ADR) (1 point), female (2 points), and retrograde (2 points); the final model for mortality included ≥65 years of age (1 point), left ventricular ejection fraction ≤45% (1 point), moderate-severe calcification (1 point), ADR (1 point), and retrograde (1 point); the final model for pericardiocentesis included ≥65 years of age (1 point), female (1 point), moderate-severe calcification (1 point), ADR (1 point), and retrograde (2 points); the final model for acute MI included prior coronary artery bypass graft surgery (1 point), atrial fibrillation (1 point), and blunt stump (1 point). The C-statistics of the models were 0.74, 0.80, 0.78, 0.72 for MACE, mortality, pericardiocentesis, and acute MI, respectively. CONCLUSIONS: The PROGRESS-CTO complication risk scores can facilitate estimation of the periprocedural complication risk in patients undergoing CTO PCI.

Antegrade dissection and re-entry versus parallel wiring in chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: The comparative efficacy and safety of parallel wiring versus antegrade dissection and re-entry (ADR) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is controversial. METHODS: We compared the clinical and angiographic characteristics and outcomes of parallel wiring versus ADR after failed antegrade wiring in a large, multicenter CTO PCI registry. RESULTS: A total of 1725 CTO PCI procedures with failed antegrade wiring with a single wire were approached with parallel wiring (692) or ADR (1033) at the discretion of the operator. ADR patients were older (65 ± 10 vs. 62 ± 10, years, p < 0.001) and had higher prevalence of comorbidities, such as diabetes mellitus (43% vs. 32%, p < 0.001), prior coronary artery bypass graft surgery (31% vs. 19%, p < 0.001), and lower left ventricular ejection fraction (50 ± 14 vs. 53 ± 11%, p < 0.001). The ADR group had higher J-CTO (2.8 ± 1.1 vs. 2.1 ± 1.3, p < 0.001) and PROGRESS-CTO (1.6 ± 1.1 vs. 1.2 ± 1.0, p < 0.001) scores. Equipment use including guidewires, balloons, and microcatheters was higher, and the procedures lasted longer in the ADR group. Technical success (78% vs. 75%, p = 0.046) and major adverse cardiovascular events (composite of all-cause mortality, stroke, acute myocardial infarction, emergency surgery or re-PCI, and pericardiocentesis) (3.7% vs. 1.9%, p = 0.029) were higher in the ADR group, with similar procedural success (75% vs. 73%, p = 0.166). CONCLUSION: In lesions that could not be crossed with antegrade wiring, ADR was associated with higher technical but not procedural success, and also higher MACE compared with parallel wiring.

Radial access for chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

Use of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has been increasing. We examined the clinical characteristics and procedural outcomes of patients who underwent CTO PCI with radial versus femoral access in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). Of 10,954 patients who underwent CTO PCI at 55 centers in 7 countries between 2012 and 2022, 2578 (24%) had a radial only approach. Patients who underwent radial only access were younger (63 ± 10 vs. 65 ± 10, years, p &lt; 0.001), more likely to be men (84% vs. 81%, p = 0.001), and had significantly lower prevalence of comorbidities compared with the femoral access group including diabetes mellitus (39% vs. 45%, p &lt; 0.001) and coronary artery bypass graft surgery (57% vs. 64%, p &lt; 0.001). In addition, radial only cases had lower angiographic complexity with lower J-CTO and PROGRESS-CTO scores. After adjusting for potential confounders, radial only access was associated with lower risk of access site complications (odds ratio [OR]: 0.45, 95% confidence interval [CI]: 0.22-0.91), similar technical success (OR: 0.87, 95% CI: 0.74-1.04) and major adverse cardiovascular events (MACE) (OR: 0.65, 95% CI: 0.40-1.07), compared with the femoral access group. Radial only access was used in 24% of CTO PCIs and was associated with lower access site complications, and similar technical success and MACE as compared with the femoral access group.

Predictors of success in primary retrograde strategy in chronic total occlusion percutaneous coronary intervention: insights from the PROGRESS-chronic total occlusion registry.

BACKGROUND: An upfront (primary) retrograde strategy is often used in complex chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical, angiographic characteristics, and procedural outcomes of CTO PCIs that were approached with a primary retrograde strategy in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). RESULTS: Of 10,286 CTO PCIs performed between 2012 and 2022, a primary retrograde strategy was used in 1329 (13%) with an initial technical success of 66%, and a final success of 83%. Patients who underwent successful versus unsuccessful primary retrograde cases had similar characteristics: age (65 ± 10 vs. 65 ± 9, years, p = 0.203), men (83% vs. 87%, p = 0.066), prior PCI (71% vs. 71%, p = 0.809), and prior coronary artery bypass graft surgery (52% vs. 53%, p = 0.682). The PROGRESS-CTO score (1.3 ± 0.9 vs. 1.6 ± 0.9, p < 0.001), air kerma radiation (3.9 ± 2.8 vs. 3.4 ± 2.6, gray, p = 0.013), and contrast use (294 ± 148 ml vs. 248 ± 128, ml, p < 0.001) were higher in the unsuccessful group, whereas the presence of interventional collaterals (95% vs. 72%, p < 0.001) and Werner collateral connection grade 2 (43% vs. 31%, p < 0.001) were higher in the successful group. On multivariable logistic regression analysis, the only variable associated with a successful primary retrograde strategy was the presence of interventional collaterals: odds ratio: 6.52 (95% confidence intervals; 3.5-12.1, p < 0.001). CONCLUSION: Presence of interventional collaterals is independently associated with higher success rates with a primary retrograde strategy in CTO PCI.

Prevalence and outcomes of balloon undilatable chronic total occlusions: Insights from the PROGRESS-CTO.

BACKGROUND: The prevalence, treatment, and outcomes of balloon undilatable lesions encountered in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study. METHODS: We examined the clinical characteristics and procedural outcomes of balloon undilatable lesions in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). RESULTS: Of 6535 CTO PCIs performed between 2012 and 2022, 558 (8.5%) lesions were balloon undilatable. In this subset, patients were older (mean age 67 ± 10 vs. 64 ± 10, p < 0.001) and had higher prevalence of comorbidities: diabetes mellitus (54% vs. 40%, p < 0.001), prior PCI (71% vs. 59%, p < 0.001), prior myocardial infarction (52% vs. 45%, p = 0.003), and prior coronary artery bypass graft surgery (44% vs. 25%, p < 0.001). The CTO lesion length was estimated to be 34 ± 23 mm, mean J-CTO score was 2.9 ± 1.1 and mean PROGRESS-CTO score was 1.4 ± 1.0. A cutting balloon was used in 27%, a scoring balloon in 15%, laser in 14%, rotational atherectomy in 28%, orbital atherectomy in 10%, intravascular lithotripsy in 1% and other modalities/approaches in 5%. Balloon undilatable lesions had lower technical success (90.9% vs. 93.8%, p = 0.007) and higher incidence of major adverse cardiovascular events (MACE) (composite of in-hospital death, acute myocardial infarction, stroke, re-PCI, emergency CABG, and pericardiocentesis) (5.0% versus 1.3%, p < 0.001). CONCLUSION: Approximately 1 in 12 CTO (8.5%) lesions are balloon undilatable. Treatment of balloon undilatable lesions is associated with lower technical success and higher in-hospital MACE.

Outcomes of chronic total occlusion percutaneous coronary intervention in patients with reduced left ventricular ejection fraction.

BACKGROUND: The relationship between left ventricular ejection fraction (LVEF) and the success and safety of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We examined the clinical characteristics and outcomes of CTO PCI in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO) after stratifying patients by LVEF (≤35%, 36%-49%, and ≥50%). RESULTS: A total of 7827 CTO PCI procedures with LVEF data were included. Mean age was 64 ± 10 years, 81% were men, 43% had diabetes mellitus, 61% had prior PCI, 45% had prior myocardial infarction, and 29% had prior coronary artery bypass graft surgery. Technical success was similar in the three LVEF strata: 85%, 86%, and 87%, p = 0.391 for LVEF ≤35%, 36%-49%, and ≥50%, respectively. In-hospital mortality was higher in lower LVEF patients (1.1%, 0.4%, and 0.3%, respectively, p = 0.001). In-hospital major adverse cardiovascular events (MACE) were numerically higher in lower EF patients (2.7%, 2.1%, and 1.9%, p = 0.271). At a median follow-up of 2 months (interquartile range: 19-350 days), patients with lower LVEF continued to have higher mortality (4.9%, 3.2%, and 1.4%, p < 0.001) while the MACE rates were similar (9.3%, 9.6%, and 7.4%, p = 0.172). CONCLUSION: CTO PCI can be performed with high technical success in patients with reduced LVEF but is associated with higher in-hospital and post-discharge mortality.

Outcomes of retrograde chronic total occlusion percutaneous coronary intervention: A report from the OPEN-CTO registry.

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 < .001) and technical success lower (82.4 vs. 94.2%; p < .001) in retrograde compared with antegrade-only procedures. All-cause death was higher in the retrograde group in-hospital (2 vs. 0%; p = .003), but not at 1-year (4.9 vs. 3.3%; p = .29). Compared with antegrade-only procedures, in-hospital MACCE rates (composite of all-cause death, stroke, MI, emergency cardiac surgery, and clinically significant perforation) were higher in the retrograde group (10.8 vs. 3.3%; p < .001) and at 1-year (19.5 vs. 13.9%; p = .03). In sensitivity analyses landmarked at discharge, there was no difference in MACCE rates at 1 year following retrograde versus antegrade-only CTO PCI. Improvements in Seattle Angina Questionnaire Quality of Life scores at 1-year were similar between the retrograde and antegrade-only groups (29.9 vs 30.4; p = .58). CONCLUSIONS: In the OPEN-CTO registry, retrograde CTO procedures were associated with higher rates of in-hospital MACCE compared with antegrade-only; however, post-discharge outcomes, including quality of life improvements, were similar between technical modalities.

In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients With Prior Coronary Artery Bypass Graft Surgery.

BACKGROUND: We examined the procedural outcomes of chronic total occlusions (CTO) percutaneous coronary interventions in patients with prior coronary artery bypass graft surgery (CABG). METHODS AND RESULTS: We compared the clinical, angiographic characteristics and outcomes of 3486 CTO interventions performed in patients with (n=1101) and without (n=2317) prior CABG at 21 centers. Prior CABG patients (32% of total cohort) were older (67±9 versus 63±10 years; P<0.001) and had more comorbidities and lower left ventricular ejection fraction (50% [40-58] versus 55% [45-60]; P<0.001). The CTO target vessel in prior CABG patients was the right coronary artery (56%), circumflex (26%), and left anterior descending artery (17%). The mean J-CTO (2.9±1.2 versus 2.2±1.3; P<0.001) and PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; 1.5±1.1 versus 1.2±1.0; P<0.001) score was higher in prior CABG patients. Retrograde (53% versus 30%, P<0.001) and antegrade dissection reentry (35% versus 28%; P<0.001) techniques were used more frequently in prior CABG patients. Prior CABG patients had lower technical (84% versus 89%; P<0.001) and procedural (82% versus 87%, P<0.001) success, but similar incidence of in-hospital major complications (3.1% versus 2.5%; P=0.287). In-hospital mortality (1% versus 0.4%; P=0.016) and coronary perforation (7.1% versus 3.1%; P<0.001) occurred more frequently in prior CABG patients, however, CABG patients had a lower incidence of pericardial tamponade (0.1% versus 1.0%; P=0.002) and pericardiocentesis (0% versus 1.3%; P<0.001). CONCLUSIONS: In a large multicenter CTO percutaneous coronary interventions registry, prior CABG patients had lower success rate but similar overall risk for complications, although mortality was higher and the incidence of tamponade was lower. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02061436.

Usefulness of Atherectomy in Chronic Total Occlusion Interventions (from the PROGRESS-CTO Registry).

There is limited data on the use of atherectomy during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We compared the clinical and procedural characteristics and outcomes of CTO PCIs performed with or without atherectomy in a contemporary multicenter CTO PCI registry. Between 2012 and 2018, 3,607 CTO PCIs were performed at 21 participating centers. Atherectomy was used in 117 (3.2%) cases: rotational atherectomy in 105 cases, orbital atherectomy in 8, and both in 4 cases. Patients in whom atherectomy was used, were older (68 ± 8 vs 64 ± 10 years, p <0.0001) and had higher Japan-chronic total occlusion score (3.0 ± 1.2 vs 2.4 ± 1.3, p <0.0001). CTO PCI cases in which atherectomy was used had similar technical (91% vs 87%, p = 0.240) and procedural (90% vs 85%, p = 0.159) success and in-hospital major adverse cardiac event (4% vs 3%, p = 0.382) rates. However, atherectomy cases were associated with higher rates of donor vessel injury (4% vs 1%, p = 0.031), tamponade requiring pericardiocentesis (2.6% vs 0.4%, p = 0.012) and more often required use of a left ventricular assist device (9% vs 5%, p = 0.031). Atherectomy cases were associated with longer procedural duration (196 [141, 247] vs 119 [76, 180] minutes, p <0.0001), and higher patient air kerma radiation dose (3.6 [2.5, 5.6] vs 2.8 [1.6, 4.7] Gray, p = 0.001). In conclusion, atherectomy is currently performed in approximately 3% of CTO PCI cases and is associated with similar technical and procedural success and overall major adverse cardiac event rates, but higher risk for donor vessel injury and tamponade.

Procedural Outcomes of Percutaneous Coronary Interventions for Chronic Total Occlusions Via the Radial Approach: Insights From an International Chronic Total Occlusion Registry.

OBJECTIVES: This study examined the frequency and outcomes of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Radial access improves the safety of PCI, but its role in CTO PCI remains controversial. METHODS: We compared the clinical, angiographic, and procedural characteristics of 3,790 CTO interventions performed between 2012 and 2018 via radial-only access (RA) (n = 747) radial-femoral access (RFA) (n = 844) and femoral-only access (n = 2,199) access at 23 centers in the United States, Europe, and Russia. RESULTS: Patients' mean age was 65 ± 10 years, and 85% were men. Transradial access (RA and RFA) was used in 42% of CTO interventions and significantly increased over time from 11% in 2012 to 67% in 2018 (p < 0.001). RA patients were younger (age 62 ± 10 years vs. 64 ± 10 years and 65 ± 10 years; p < 0.001), less likely to have undergone prior coronary artery bypass graft surgery (18% vs. 39% and 35%; p < 0.001), and less likely to have undergone prior PCI (60% vs. 63% and 66%; p = 0.005) compared with those who underwent RFA and femoral-only access PCI. RA CTO PCI lesions had lower J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 1.4 vs. 2.6 ± 1.3 and 2.5 ± 1.3; p < 0.001) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) complication (2.3 ± 1.9 vs. 3.2 ± 2.0 and 3.2 ± 1.9; p < 0.001) scores. The mean sheath size was significantly smaller in the RA group (6.6 ± 0.7 vs. 7.0 ± 0.6 and 7.3 ± 0.8; p < 0.0001), although it increased with lesion complexity. Antegrade dissection re-entry (20% vs. 33% and 32%; p < 0.001) was less commonly used with RA, whereas use of retrograde techniques was highest with RFA (47%). The overall rates of technical success (89% vs. 88% vs. 86%; p = 0.061), procedural success (86% vs. 85% vs. 85%; p = 0.528), and in-hospital major complication (2.47% vs. 3.40% vs. 2.18%; p = 0.830) were similar in all 3 groups, whereas major bleeding was lower in the RA group (0.55% vs. 1.94% and 0.88%; p = 0.013). CONCLUSIONS: Transradial access is increasingly being used for CTO PCI and is associated with similar technical and procedural success and lower major bleeding rates compared with femoral-only access interventions. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Prevalence and Outcomes of Percutaneous Coronary Interventions for Ostial Chronic Total Occlusions: Insights From a Multicenter Chronic Total Occlusion Registry.

BACKGROUND: Ostial chronic total occlusions (CTOs) can be challenging to recanalize. METHODS: We sought to examine the prevalence, angiographic presentation, and procedural outcomes of ostial (side-branch ostial and aorto-ostial) CTOs among 1000 CTO percutaneous coronary interventions (PCIs) performed in 971 patients between 2015 and 2017 at 14 centres in the US, Europe, and Russia. RESULTS: Ostial CTOs represented 16.9% of all CTO PCIs: 9.6% were aorto-ostial, and 7.3% were side-branch ostial occlusions. Compared with nonostial CTOs, ostial CTOs were longer (44 ± 33 vs 29 ± 19 mm, P < 0.001) and more likely to have proximal-cap ambiguity (55% vs 33%, P < 0.001), moderate/severe calcification (67% vs 45%, P < 0.001), a diffusely diseased distal vessel (41% vs 26%, P < 0.001), interventional collaterals (64% vs 53%, P = 0.012), and previous coronary artery bypass graft surgery (CABG) (51% vs 27%, P < 0.001). The retrograde approach was used more often in ostial CTOs (54% vs 29%, P < 0.001) and was more often the final successful crossing strategy (30% vs 18%, P = 0.003). Technical (81% vs 84%, P = 0.280), and procedural (77% vs 83%, P = 0.112) success rates and the incidence of in-hospital major complication were similar (4.8% vs 2.2%, P = 0.108), yet in-hospital mortality (3.0% vs 0.5%, P = 0.010) and stroke (1.2% vs 0.0%, P = 0.030) were higher in the ostial CTO PCI group. In multivariable analysis, ostial CTO location was not independently associated with higher risk for in-hospital major complications (adjusted odds ratio 1.27, 95% confidence intervals 0.37 to 4.51, P = 0.694). CONCLUSIONS: Ostial CTOs can be recanalized with similar rates of success as nonostial CTOs but are more complex, more likely to require retrograde crossing and may be associated with numerically higher risk for major in-hospital complications.

In-hospital Outcomes of Attempting More Than One Chronic Total Coronary Occlusion Through Percutaneous Intervention During the Same Procedure.

The frequency and outcomes of patients who underwent chronic total occlusion (CTO) percutaneous coronary intervention (PCI) of more than one CTO during the same procedure have received limited study. We compared the clinical and angiographic characteristics and procedural outcomes of patients who underwent treatment of single versus >1 CTOs during the same procedure in 20 centers from the United States, Europe, and Russia. A total of 2,955 patients were included: mean age was 65 ± 10 years and 85% were men with high prevalence of previous myocardial infarction (46%), and previous coronary artery bypass graft surgery (33%). More than one CTO lesions were attempted during the same procedure in 58 patients (2.0%) and 70% of them were located in different major epicardial arteries. Compared with patients who underwent PCI of a single CTO, those who underwent PCI of >1 CTOs during the same procedure had similar J-CTO (2.4 ± 1.3 vs 2.5 ± 1.3, p = 0.579) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (1.5 ± 1.2 vs 1.3 ± 1.0 p = 0.147) scores. The multi-CTO PCI group had similar technical success (86% vs 87%, p = 0.633), but higher risk of in-hospital major complications (10.3% vs 2.7%, p = 0.005), and consequently numerically lower procedural success (79% vs 85%, p = 0.197). The multi-CTO PCI group had higher in-hospital mortality (5.2% vs 0.5%, p = 0.005) and stroke (5.2%vs 0.2%, p <0.001), longer procedure duration (162 [117 to 242] vs 122 [80 to 186] minutes, p <0.001) and higher radiation dose (3.6 [2.1 to 6.4] vs 2.9 [1.7 to 4.7] Gray, p = 0.033). In conclusion, staged revascularization may be the preferred approach in patients with >1 CTO lesions requiring revascularization, as treatment during a single procedure was associated with higher risk for periprocedural complications.

The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry.

OBJECTIVES: The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents. BACKGROUND: CTO PCI has been evolving with constant improvement of equipment and techniques. METHODS: Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia. RESULTS: The mean age was 65 ± 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 ± 1.3 and 1.3 ± 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively. CONCLUSIONS: CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Association of Transcatheter Aortic Valve Replacement With 30-Day Renal Function and 1-Year Outcomes Among Patients Presenting With Compromised Baseline Renal Function: Experience From the PARTNER 1 Trial and Registry.

Importance: The frequency of baseline renal impairment among high-risk and inoperable patients with severe aortic stenosis undergoing a transcatheter aortic valve replacement (TAVR) and the effect of TAVR on subsequent renal function are, to our knowledge, unknown. Objective: To determine the effect of TAVR among patients with baseline renal impairment. Design, Setting, and Participants: This substudy of patients with baseline renal impairment (estimated glomerular filtration rate [eGFR] ≤ 60 mL/min) and paired baseline and 30-day measures of renal function undergoing TAVR in the PARTNER 1 trial and continued access registries was conducted in 25 centers in the United States and Canada. Main Outcomes and Measures: Patients were categorized with improved eGFR (30-day follow-up eGFR≥10% higher than baseline pre-TAVR), worsened eGFR (≥10% lower), or no change in renal function (neither). Baseline characteristics, 30-day to 1-year all-cause mortality, and repeat hospitalization were compared. Multivariable models were constructed to identify predictors of 1-year mortality and of improvement/worsening in eGFR. Results: Of the 821 participants, 401 (48.8%) were women and the mean (SD) age for participants with improved, unchanged, or worsening eGFR was 84.90 (6.91) years, 84.37 (7.13) years, and 85.39 (6.40) years, respectively. The eGFR was 60 mL/min or lower among 821 patients (72%), of whom 345 (42%) improved, 196 (24%) worsened, and 280 (34%) had no change at 30 days. There were no differences in baseline age, body mass index, diabetes, chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, hypertension, pulmonary hypertension, renal or liver disease, New York Heart Association III/IV symptoms, transaortic gradient, left ventricular ejection fraction, or procedural characteristics. The group with improved eGFR had more women, nonsmokers, and a lower cardiac index. Those with worsening eGFR had a higher median Society of Thoracic Surgeons score and left ventricle mass. From 30 days to 1 year, those with improved eGFR had no difference in mortality or repeat hospitalization. Those with worsening eGFR had increased mortality (25.5% vs 19.1%, P = .07) but no significant increases in repeat hospitalization or dialysis. Predictors of improved eGFR were being female (odds ratio [OR], 1.38; 95% CI, 1.03-1.85; P = .03) and nonsmoking status (OR, 1.49; 95% CI, 1.11-1.01; P = .01); predictors of worsening eGFR were baseline left ventricle mass (OR, 1.00; 95% CI, 1.00-1.01; P = .01), smoking (OR, 1.51; 95% CI, 1.06-2.14; P = .02), and age (OR, 1.03; 95% CI, 1.00-1.05; P = .05); and predictors of 1-year mortality were baseline left ventricular ejection fraction (OR, 0.98; 95% CI, 0.97-0.99; P = .003), baseline eGFR (OR, 0.98; 95% CI, 0.96-0.99; P < .001), and worsening eGFR vs no change in eGFR (OR, 1.51; 95% CI, 1.02-2.24; P = .04). Conclusions and Relevance: Baseline renal impairment was frequent among patients who underwent TAVR. While improved eGFR did not improve 1-year outcomes, worsening eGFR was associated with increased mortality. Trial Registration: clinicaltrials.gov Identifier: NCT00530894.

Impact of Preoperative Chronic Kidney Disease in 2,531 High-Risk and Inoperable Patients Undergoing Transcatheter Aortic Valve Replacement in the PARTNER Trial.

BACKGROUND: Although preoperative renal dysfunction (RD) is associated with increased mortality and morbidity after surgical aortic valve replacement, its impact on clinical outcomes after transcatheter aortic valve replacement (TAVR) is less defined. METHODS: TAVR patients in the PARTNER (Placement of Aortic Transcatheter Valves) trial with a calculable glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease equation were included. Patients were divided into three groups: GFR >60 mL/min (none/mild RD), GFR 31 to 60 mL/min (moderate RD), and GFR ≤30 mL/min (severe RD). Operative characteristics and clinical outcomes were analyzed. Cox regression models were used to determine multivariable predictors of 1-year all-cause mortality. RESULTS: A total of 2,531 inoperable or high surgical risk patients from the PARTNER trial and continued access registries had a calculable GFR level: 767 (30%) had normal renal function or mild RD, 1,473 (58%) had moderate RD, and 291 (12%) presented with severe RD. The mean Society of Thoracic Surgeons Predicted Risk of Mortality for the cohort was 11.5%, and it was highest in those with severe RD (13.8%). Patients with severe RD were more often women with a higher prevalence of diabetes. Patients with severe RD had the highest incidence of 30-day and 1-year all-cause mortality and rehospitalization. The 30-day rate of death from any cause was 10.7% in the severe RD group versus 6.0% in the moderate and mild RD groups (p = 0.01). The 1-year rate of death from any cause was 34.4% in the severe RD group versus 21.5% in the moderate RD and 20.8% in the none/mild RD groups (adjusted hazard ratio [HR] 2.24, p < 0.0001 for severe versus none/mild; adjusted HR 1.14, p = 0.24 for severe versus moderate). Other significant predictors of 1-year all-cause mortality included lower body mass index, frailty, the transapical approach, a lower ejection fraction, oxygen-dependent chronic obstructive pulmonary disease, liver disease, and male sex. CONCLUSIONS: Preoperative severe RD is a significant predictor for 1-year mortality in TAVR patients. Careful risk stratification by the heart team is required in patients with severe preprocedural RD.