Balloon aortic valvuloplasty to improve candidacy of patients evaluated for transcatheter aortic valve replacement.

OBJECTIVES: Evaluate the role of balloon aortic valvuloplasty (BAV) in improving candidacy of patients for transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients who are not candidates for TAVR may undergo BAV to improve functional and clinical status. METHODS: 117 inoperable or high-risk patients with critical aortic stenosis underwent BAV as a bridge-to-decision for TAVR. Frailty measures including gait speed, serum albumin, hand grip, activities of daily living (ADL); and NYHA functional class before and after BAV were compared. RESULTS: Mean age was 81.6 ± 8.5 years and the mean Society of Thoracic Surgeons predicted risk of mortality was 9.57 ± 5.51, with 19/117 (16.2%) patients non-ambulatory. There was no significant change in mean GS post-BAV, but all non-ambulatory patients completed GS testing at follow-up. Albumin and hand grip did not change after BAV, but there was a significant improvement in mean ADL score (4.85 ± 1.41 baseline to 5.20 ± 1.17, P = 0.021). The number of patients with Class IV congestive heart failure (CHF) was significantly lower post BAV (71/117 [60.7%] baseline versus 18/117 [15.4%], P = 0.008). 78/117 (66.7%) of patients were referred to definitive valve therapy after BAV. CONCLUSIONS: When evaluating frailty measures post BAV, we saw no significant improvement in mean GS, however, we observed a significant improvement in non-ambulatory patients and ADL scores. We also describe improved Class IV CHF symptoms. With this improved health status, the majority of patients underwent subsequent valve therapy, demonstrating that BAV may improve candidacy of patients for TAVR.

The outcomes of transcatheter aortic valve replacement in a cohort of patients with end-stage renal disease.

OBJECTIVES: To examine whether transcatheter aortic valve replacement (TAVR) is a safe and effective treatment option for aortic stenosis in patients with end-stage renal disease (ESRD). BACKGROUND: Patients with ESRD undergoing surgical aortic valve replacement have an operative mortality approaching 20% and a 10-year survival of approximately 12%. We investigated whether TAVR is a more reasonable option. METHODS: This is a multicenter, retrospective study of all patients with ESRD who underwent TAVR in 8 institutions between 12/2011 and 02/2013. Demographic characteristics, mortality, major, and minor complications were evaluated. Outcomes were stratified by operative approach. RESULTS: Forty-three patients with a mean age 76.2 ± 11.0 years and a mean STS predicted risk of mortality of 15.53 ± 8.70% underwent TAVR. Mean duration of dialysis was 45.2 ± 52.3 months (median 29.5 months). Transfemoral (TF) TAVR was performed in 31/43 (72.1%), transapical in 11/43 (25.6%), and transaortic in 1/43 (2.3%). Operative mortality was 14.0% (6/43) with TF mortality 6.5% (2/31) and 33.3% (4/12) in non-TF patients. Six-month mortality was 11/43 (25.6%: 16.1% TF, 50.0% non-TF). Complications included stroke in 2.3% (1/43) and life-threatening or major bleeding in 14.0% (6/43). Discharge to another healthcare facility was 27.0% (10/37). Readmission within 30 days of procedure for any cause was 18.9% (7/37). CONCLUSIONS: Patients with ESRD who undergo TAVR are at high risk for mortality and complications. TAVR outcomes are comparable to but not substantially better than those with SAVR. Transfemoral TAVR seems to be at least as safe and effective as the current standard SAVR in patients undergoing aortic valve replacement. © 2016 Wiley Periodicals, Inc.

Use of novel antiplatelet agents in acute coronary syndromes.

Acute coronary syndromes (ACS) encompass a broad spectrum of clinical presentations based on underlying pathology that results in myocardial ischemia and/or infarction. Despite advancements in invasive management and secondary preventive therapies, recurrent atherothrombotic coronary events remain a prevalent cause of death and recurrent cardiac events after ACS and, in those who survive, the root of long-standing cardiac comorbidities. Antiplatelet drug therapy has proven beneficial in the reduction of these events, and novel antiplatelet agents have resulted in significant improvement in clinical outcomes over the last decade. However, the balance of optimal platelet inhibition with minimal bleeding complications remains a clinical challenge. This review focuses on more recent advances in antiplatelet therapies used in the treatment of ACS.

Aortic root rupture after TAVR in two renal transplant patients on chronic immunosuppressant therapy.

Patients on chronic immunosuppressant therapy after renal transplantation have a high rate of in-hospital mortality and approximately 20% mortality rate per year after conventional valve surgery. While transcatheter aortic valve replacement (TAVR) is an appealing option to consider for such patients, there are not significant outcome data for the procedure in this patient population. We report two cases of aortic root rupture after TAVR in renal transplant patients on chronic immunosuppressant therapy.

Outcomes of small coronary artery stenting with bare-metal stents versus drug-eluting stents: results from the NHLBI Dynamic Registry.

OBJECTIVES: Examine 1-year outcomes of patients with small coronary arteries in the National Heart, Lung, and Blood Institute Dynamic Registry (NHLBI) undergoing drug-eluting stent (DES) vs. bare-metal stent (BMS) placement. BACKGROUND: While randomized trials of DES vs. BMS demonstrate reduced target vessel revascularization, it is unclear whether similar outcomes are seen in unselected patients after percutaneous coronary intervention (PCI) for small coronary arteries. METHODS: Utilizing patients from the NHLBI Registry Waves 1-3 for BMS (1997-2002) and Waves 4-5 for DES (2004 and 2006), demographic, angiographic, in-hospital, and 1-year outcome data of patients with small coronary arteries treated with BMS (n = 686) vs. DES (n = 669) were evaluated. Small coronary artery was defined as 2.50-3.00 mm in diameter. RESULTS: Compared to BMS-treated patients, the mean lesion length of treated lesions was longer in the DES treated group (16.7 vs. 13.1 mm, P < 0.001) and the mean reference vessel size of attempted lesions was smaller (2.6 vs. 2.7 mm, P < 0.001). Adjusted analyses of 1-year outcomes revealed that DES patients were at lower risk to undergo coronary artery bypass graft surgery (Hazard Ratio [HR] 0.40, 95% confidence interval [CI] 0.17-0.95, P = 0.04), repeat PCI (HR 0.53, 95% CI 0.35-0.82, P = 0.004), and experience the combined major adverse cardiovascular event rate (HR 0.59, 95% CI 0.42-0.83, P = 0.002). There was no difference in the risk of death and myocardial infarction (MI) (HR 0.78, 95% CI 0.46-1.35, P = 0.38). CONCLUSIONS: In this real-world registry, patients with small coronary arteries treated with DES had significantly lower rates of repeat revascularization and major adverse cardiovascular events at 1 year compared to patients treated with BMS, with no increase in the risk of death and MI. These data confirm the efficacy and safety of DES over BMS in the treatment of small coronary arteries in routine clinical practice.

Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR.

OBJECTIVES: To compare iliofemoral arterial complications with transfemoral transcatheter aortic valve replacement (TF-TAVR) utilizing surgical cutdown versus percutaneous access with closure devices in a randomized trial. BACKGROUND: Major vascular complications following TAVR are a significant risk of the procedure. There are no randomized data comparing whether access method in TF-TAVR influences the risk of such complications. METHODS: From June to December 2011, 30 consecutive patients undergoing TF-TAVR were randomized to either surgical cutdown (C) or percutaneous (P) access. Subjects underwent preoperative CT scans, pre- and post-operative bilateral femoral arterial ultrasound and angiography. The primary endpoint was the composite of major and minor vascular complications at 30 days, as defined by the Valve Academic Research Consortium-2. Multivariate predictors of vascular complications were identified. RESULTS: Of the 30 subjects enrolled, 27 were treated with the randomized method of access as randomized. Iliofemoral complications were observed in eight patients (26.7%; C = 4, P = 4), all of which were dissections and/or stenoses that required percutaneous and/or surgical intervention. There were two (13.3%) major and two (13.3%) minor complications in each group. Two covariates that were significantly associated with vascular complications included female sex and baseline femoral arterial velocity on ultrasound. CONCLUSIONS: While surgical cutdown in TF-TAVR is the recommended access for new centers initiating a TAVR program, this small randomized pilot study suggests the lesser invasive percutaneous method in an experienced center is equivalent in safety to the surgical method. Doppler ultrasound may be useful in predicting complications prior to the procedure.

Comparison of drug-eluting and bare metal stents in large coronary arteries: findings from the NHLBI dynamic registry.

OBJECTIVES: This study sought to evaluate the safety and effectiveness of drug-eluting stents (DES) compared to bare-metal stents (BMS) for patients with large coronary vessels. BACKGROUND: Randomized trials have demonstrated that DES reduce the risk of target vessel revascularization (TVR) compared to BMS. This benefit is less pronounced as artery diameter increases. Whether DES are superior to BMS for larger coronary arteries in the setting of routine clinical practice is unknown. METHODS: We analyzed data from 869 patients undergoing de novo lesion PCI with reference vessel diameter greater than or equal to 3.5 mm in the NHLBI Dynamic Registry according to whether they were treated with DES or BMS. Patients were followed for 3 years for the occurrence of cardiovascular events. RESULTS: At 3-year follow-up, rates of TVR at 3 years were similar and low in both groups (4.4% vs. 3.7%, P = 0.62). After adjustment for differences in baseline characteristics, the adjusted hazard ratio for 3-year MI for DES was 1.85 (95% CI 0.93-3.7, P = 0.08), for TVR at 3 years 1.14 (95% CI 0.52-2.49, P = 0.75) and for mortality 0.89 (95%CI 0.49-1.62, P = 0.71). CONCLUSIONS: In our study of the unrestricted use of DES for patients with lesions in larger diameter coronary arteries, first generation DES did not reduce 3-year risk of TVR. Our findings do not support the preferred use of DES over BMS for patients with lesions located in arteries >3.5 mm. It is unknown whether secondary generation DES can offer better outcome compared to BMS in large coronary vessels. Further study on this issue is warranted.

Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI).

Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment.

Association of chronic lung disease with treatments and outcomes patients with acute myocardial infarction.

BACKGROUND: Although chronic lung disease (CLD) is common among patients with myocardial infarction (MI), little is known about the influence of CLD on patient management and outcomes following MI. METHODS: Using the National Cardiovascular Data Registry's ACTION Registry-GWTG, demographics, clinical characteristics, treatments, processes of care, and in-hospital adverse events after acute MI were compared between patients with (n = 22,624) and without (n = 136,266) CLD. Multivariable adjustment was performed to determine the independent association of CLD with treatments and adverse events. RESULTS: CLD (17.0% of non-ST-elevation MI [NSTEMI] and 10.1% of ST-elevation MI [STEMI] patients) was associated with older age, female sex, and a greater burden of comorbidities. Among NSTEMI patients, those with CLD were less likely to undergo cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft compared to those without; in contrast, no differences were seen in invasive therapies for STEMI patients with or without CLD. Multivariable-adjusted risk of major bleeding was significantly increased in CLD patients with NSTEMI (13.0% vs 8.1%, OR(adj) = 1.27, 95% CI = 1.20-1.34, P < .001) and STEMI (16.0% vs 10.5%, OR(adj) = 1.19, 95% CI = 1.10-1.29, P < .001). In NSTEMI, CLD was associated with a higher risk of inhospital mortality (OR(adj) = 1.21, 95% CI = 1.11-1.33); in STEMI no association between CLD and mortality was seen (OR(adj) = 1.05, 95% CI = 0.95-1.17). CONCLUSIONS: CLD is common among patients with MI and is independently associated with an increased risk for major bleeding. In NSTEMI, CLD is also associated with receiving less revascularization and with increased in-hospital mortality. Special attention should be given to this high-risk subgroup for the prevention and management of complications after MI.

Effect of percutaneous coronary intervention on quality of life: a consensus statement from the Society for Cardiovascular Angiography and Interventions.

Percutaneous coronary intervention (PCI) decreases ischemic complications of acute coronary syndromes. The benefits of PCI in stable ischemic heart disease (SIHD) depend on its effect on quality of life (QoL), including angina, physical activity, and emotional well-being. PCI decreases angina and the need for anti-anginal medications, and increases exercise capacity and QoL, compared with baseline status and compared with medical therapy without PCI. These benefits are greater when QOL is markedly impaired by severe angina before the procedure. When considering treatment options for symptomatic SIHD, physicians should consider and provide objective data regarding QoL effects for each treatment strategy. QoL outcomes should be considered in clinical trials, appropriate use criteria, practice guidelines, and reimbursement policies for PCI.

Transfemoral use of the GuideLiner catheter in complex coronary and bypass graft interventions.

The GuideLiner catheter (Vascular Solutions, Minneapolis, MN) is a novel, rapid exchange catheter that allows deep vessel intubation. We describe 21 patients in whom the GuideLiner catheter [7 French (F) in 76% and 6F in 24%] was used to facilitate equipment delivery (n = 14) or vessel engagement (n = 7). Pressure dampening after GuideLiner catheter insertion was observed in 12 patients (57%). The procedure was successfully completed in 19 patients (90%) and one patient developed acute vessel closure, likely due to dissection. The GuideLiner catheter can facilitate complex coronary interventions but should be used with caution to minimize the risk for vessel injury.

A comparison of bare-metal and drug-eluting stents for off-label indications.

BACKGROUND: Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown. METHODS: We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm. RESULTS: Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents. CONCLUSIONS: Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.

Temporal changes in the outcomes of patients with diabetes mellitus undergoing percutaneous coronary intervention in the National Heart, Lung, and Blood Institute dynamic registry.

BACKGROUND: Patients with diabetes mellitus (DM) are at higher risk for adverse outcomes following percutaneous coronary intervention (PCI). METHODS: To determine whether outcomes have improved over time, we analyzed data from 2,838 consecutive patients with medically treated DM, including 1,066 patients (37.6%) treated with insulin, in the National Heart, Lung, and Blood Institute Dynamic Registry undergoing PCI registered in waves 1 (1997-1998), 2 (1999), 3 (2001-2002), 4 (2004), and 5 (2006). We compared baseline demographics and 1-year outcomes in the overall cohort and in analyses stratified by recruitment wave and insulin use. RESULTS: Crude mortality rates by chronological wave were 9.5%, 12.5%, 8.9%, 11.6%, and 6.6% (P value(trend) = .33) among those treated with insulin and, respectively, 9.7%, 6.5%, 4.1%, 5.4%, and 4.7% (P value(trend) = .006) among patients treated with oral agents,. The adjusted hazard ratios of death, myocardial infarction (MI), and overall major adverse cardiovascular events (death, MI, revascularization) in insulin-treated patients with DM in waves 2 to 5 as compared with wave 1 were either higher or the same. In contrast, the similar adjusted hazard ratios for oral agent-treated patients with DM were either similar or lower. CONCLUSIONS: Significant improvements over time in adverse events by 1 year were detected in patients with DM treated with oral agents. In insulin-treated diabetic patients, despite lower rates of repeat revascularization over time, death and MI following PCI have not significantly improved. These findings underscore the need for continued efforts at optimizing outcomes among patients with DM undergoing PCI, especially those requiring insulin treatment.

Relative spatial distributions of coronary artery bypass graft insertion and acute thrombosis: a model for protection from acute myocardial infarction.

BACKGROUND: Randomized trials have demonstrated coronary artery bypass surgery (CABG) to be superior to percutaneous coronary intervention with respect to long-term mortality and morbidity from myocardial infarction within specific high-risk cohorts. The purpose of this study was to analyze the spatial distribution of coronary artery bypass graft anastomoses relative to acute thromboses in native coronary arteries. We hypothesized that insertion sites of bypass grafts are located distal to sites of acute thrombosis and consequently decrease cardiac morbidity and mortality associated with plaque rupture. METHODS: We analyzed 168 patients with prior CABG and 208 patients with ST-segment elevation myocardial infarctions (STEMI) presenting to the Brigham and Women's Hospital who underwent coronary angiography. We constructed a spatial map of the coronary arterial bypass graft insertion sites and compared these locations to sites of acute thrombosis leading to STEMI. RESULTS: Graft insertion sites were consistently located distal to acute thrombosis sites (left anterior descending artery median graft insertion versus median thrombosis site = 72 versus 34 mm, right coronary artery 91 versus 42 mm, left circumflex artery 44 versus 37 mm). Greater than 97% of thrombosis sites were located proximal to 75% of graft insertion sites. CONCLUSIONS: Coronary arterial bypass grafts provide the coverage of anatomic zones at risk for STEMI. The superior performance of CABG in high risk patients may be attributed to targeting of proximal coronary locations where thrombosis risk is clustered.

Comparison of Frequency of Vascular Complications With Ultrasound-Guided Versus Fluroscopic Roadmap-Guided Femoral Arterial Access in Patients Who Underwent Transcatheter Aortic Valve Implantation.

To compare outcomes of ultrasound guidance (USG) versus fluoroscopy roadmap guidance (FG) angiography for femoral artery access in patients who underwent transfemoral (TF) transcatheter aortic valve implantation (TAVI) to determine whether routine USG use was associated with fewer vascular complications. Vascular complications are the most frequent procedural adverse events associated with TAVI. USG may provide a decreased rate of access site complications during vascular access compared with FG. Patients who underwent TF TAVI between July 2012 and July 2017 were reviewed and outcomes were compared. Vascular complications were categorized by Valve Academic Research Consortium-2 criteria and analyzed by a multivariable logistic regression adjusting for potential confounding risk factors including age, gender, body mass index, peripheral vascular disease, Society of Thoracic Surgeons score and sheath to femoral artery ratio. Of the 612 TAVI patients treated, 380 (63.1%) were performed using USG for access. Routine use of USG began in March 2015 and increased over time. Vascular complications occurred in 63 (10.3%) patients and decreased from 20% to 3.9% during the study period. There were fewer vascular complications with USG versus FG (7.9% vs 14.2%, p = 0.014). After adjusting for potential confounding risk factors that included newer valve systems, smaller sheath sizes and lower risk patients, there was still a 49% reduction in vascular complications with USG (odds ratio 0.51, 95% confidence interval 0.29 to 0.88, p = 0.02). In conclusion, USG for TF TAVI was associated with reduced vascular access site complications compared with FG access even after accounting for potential confounding risk factors and should be considered for routine use for TF TAVI.

Transcatheter Aortic Valve Replacement After Prior Mitral Valve Surgery: Results From the Transcatheter Valve Therapy Registry.

BACKGROUND: Due to perceived technical challenges, patients with previous surgical mitral valve repair or replacement (SMVR) have been excluded from most transcatheter aortic valve replacement (TAVR) trials. Our objective was to compare the 30-day and 1-year outcomes of TAVR for patients with and without prior SMVR. METHODS: In a retrospective review of The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we compared 1097 patients with prior SMVR to 46,327 patients without prior SMVR who underwent TAVR between November 2011 and September 2015 at 394 US centers. Preoperative characteristics, procedural details, and clinical outcomes were analyzed. RESULTS: Patients with previous SMVR were younger, more often female, and had higher STS predicted risk of mortality (8.6% vs 6.8%, P < .001). However, there was no difference in 30-day mortality (4.6% vs 5.5%, P = .293), myocardial infarction, stroke, reintervention, new dialysis, or readmission. Moderate/severe paravalvular leak at discharge was also similar (5.8% vs 4.9%, P = .343). At 1 year, morbidity was similar with slightly higher mortality among patients with prior SMVR (20% vs 17.5%, P = .087) that was significant after adjustment (hazard ratio 1.18, P = .043). The type of prior SMVR (repair, bioprosthetic replacement, or mechanical replacement) had no impact on 30-day or 1-year survival. CONCLUSIONS: Patients with prior SMVR undergoing TAVR had similar 30-day outcomes, slightly higher 1-year mortality, and no increase in early paravalvular leak compared with patients who did not have previous SMVR. Prior SMVR should not preclude TAVR for appropriately selected patients.

Impact of concomitant treatment of non-chronic total occlusion lesions at the time of chronic total occlusion intervention.

BACKGROUND: During chronic total occlusion (CTO) percutaneous coronary intervention (PCI), sometimes non-CTO lesions are also treated. METHODS: We compared the clinical and procedural characteristics and outcomes of CTO PCIs with and without concomitant treatment of a non-CTO lesion in a contemporary multicenter CTO registry. RESULTS: Of the 3598 CTO PCIs performed at 21 centers between 2012 and 2018, 814 (23%) also included PCI of at least one non-CTO lesion. Patients in whom non-CTO lesions were treated were older (65 ±â€¯10 vs. 64 ±â€¯10 years, p = 0.03), more likely to present with an acute coronary syndrome (32% vs. 23%, p < 0.01), and less likely to undergo PCI of a right coronary artery (RCA) CTO (46% vs. 58%, p < 0.01). The most common non-CTO lesion location was the left anterior descending artery (31%), followed by the circumflex (29%) and the RCA (25%).Combined non-CTO and CTO-PCI procedures had similar technical (88% vs. 87%, p = 0.33) and procedural (85% vs. 85%, p = 0.74) success and major in-hospital complication rates (3.4% vs. 2.7%, p = 0.23), but had longer procedure duration (131 [88, 201] vs. 117 [75, 179] minutes, p < 0.01), higher patient air kerma radiation dose (3.0 [1.9, 4.8] vs. 2.8 [1.5, 4.6] Gray, p < 0.01) and larger contrast volume (300 [220, 380] vs. 250 [180, 350] ml, p < 0.01). CONCLUSIONS: Combined CTO PCI with PCI of non-CTO lesions is associated with similar success and major in-hospital complication rates compared with cases in which only CTOs were treated, but requires longer procedure duration and higher radiation dose and contrast volume.

The Impact of Peripheral Artery Disease in Chronic Total Occlusion Percutaneous Coronary Intervention (Insights From PROGRESS-CTO Registry).

The impact of peripheral artery disease (PAD) in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We reviewed 3999 CTO PCIs performed in 3914 patients between 2012 and 2018 at 25 centers, 14% of whom had a history of PAD. We compared the clinical and angiographic characteristics and procedural outcomes of patients with versus without history of PAD. Patients with PAD were older (67 ± 9 vs 64 ± 10 years, P < .001) and had a higher prevalence of cardiovascular risk factors. They also had more complex lesions as illustrated by higher Japanese CTO score (2.7 ± 1.2 vs 2.4 ± 1.3, P < .001). In patients with PAD, the final crossing technique was less often antegrade wire escalation (40% vs 51%, P < .001) and more often the retrograde approach (23 vs 20%, P < .001) and antegrade dissection/reentry (20% vs 16%, P < .001). Technical success was similar between the 2 study groups (84% vs 87%, P = .127), but procedural success was lower for patients with PAD (81% vs 85%, P = .015). The incidence of in-hospital major adverse cardiac events was higher among patients with PAD (3% vs 2%, P = .046). In conclusion, patients with PAD undergoing CTO PCI have more comorbidities, more complex lesions, and lower procedural success.

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).