Radiation-associated lens changes in the cardiac catheterization laboratory: Results from the IC-CATARACT (CATaracts Attributed to RAdiation in the CaTh lab) study.

OBJECTIVE: To examine the relationship between occupational exposure to ionizing radiation and the prevalence of lens changes in interventional cardiologists (ICs) and catheterization laboratory ("cath-lab") staff. BACKGROUND: Exposure to ionizing radiation is associated with the development of lens opacities. ICs and cath-lab staff can receive high doses of ionizing radiation without protection, and may thus be at risk for lens opacity formation. METHODS: We conducted a cross-sectional study at an interventional cardiology conference. Study participants completed a questionnaire pertaining to occupational exposure to radiation and potential confounders for the development of cataracts, followed by slit-lamp examination and grading of lens findings. RESULTS: A total of 117 attendees participated in the study, including 99 (85%; 49 ± 11 years-old; 82% male) with occupational exposure to ionizing radiation and 18 (15%; 39 ± 12 years-old; 61% male) unexposed controls. The prevalence of overall cortical and posterior subcapsular lens changes (including subclinical findings) was higher in exposed participants compared with controls (47 vs. 17%, P = 0.015). Occupational exposure and age over 60 were independent predictors of lens changes (odds ratio [95% CI]: 6.07 [1.38-43.45] and 7.72 [1.60-43.34], respectively). The prevalence of frank opacities was low and similar between the two groups (14 vs. 6%, P = 0.461). Most lens findings consisted of subclinical changes in the periphery of the lens without impact on visual acuity. CONCLUSIONS: Compared with unexposed controls, ICs and cath-lab staff had a higher prevalence of lens changes that may be attributable to ionizing radiation exposure. While most of these changes were subclinical, they are important due to the potential to progress to clinical symptoms, highlighting the importance of minimizing staff radiation exposure.

Saphenous vein graft near-infrared spectroscopy imaging insights from the lipid core plaque association with clinical events near-infrared spectroscopy (ORACLE-NIRS) registry.

OBJECTIVES: We sought to examine near-infrared spectroscopy (NIRS) imaging findings of aortocoronary saphenous vein grafts (SVGs). BACKGROUND: SVGs are prone to develop atherosclerosis similar to native coronary arteries. They have received little study using NIRS. METHODS: We examined the clinical characteristics and imaging findings from 43 patients who underwent NIRS imaging of 45 SVGs at our institution between 2009 and 2016. RESULTS: The mean patient age was 67 ± 7 years and 98% were men, with high prevalence of diabetes mellitus (56%), hypertension (95%), and dyslipidemia (95%). Mean SVG age was 7 ± 7 years, mean SVG lipid core burden index (LCBI) was 53 ± 60 and mean maxLCBI4 mm was 194 ± 234. Twelve SVGs (27%) had lipid core plaques (2 yellow blocks on the block chemogram), with a higher prevalence in SVGs older than 5 years (46% vs. 5%, P = 0.002). Older SVG age was associated with higher LCBI (r = 0.480, P < 0.001) and higher maxLCBI4 mm (r = 0.567, P < 0.001). On univariate analysis, greater annual total cholesterol exposure was associated with higher SVG LCBI (r = 0.30, P = 0.042) and annual LDL-cholesterol and triglyceride exposure were associated with higher SVG maxLCBI4 mm (LDL-C: r = 0.41, P = 0.020; triglycerides: r = 0.36, P = 0.043). On multivariate analysis, the only independent predictor of SVG LCBI and maxLCBI4mm was SVG age. SVG percutaneous coronary intervention was performed in 63% of the patients. An embolic protection device was used in 96% of SVG PCIs. Periprocedural myocardial infarction occurred in one patient. CONCLUSIONS: Older SVG age and greater lipid exposure are associated with higher SVG lipid burden. © 2016 Wiley Periodicals, Inc.

Procedural outcomes with use of the flash ostial system in aorto-coronary ostial lesions.

BACKGROUND: The Flash Ostial system (Ostial Corporation, Sunnyvale, CA) was designed to optimize implantation of aorto-ostial coronary stents by flaring the proximal stent struts against the aortic wall. METHODS: We retrospectively reviewed the medical record, angiograms, and intravascular ultrasound images of 22 aorto-ostial percutaneous coronary interventions performed at our institution between March and September 2015. The Flash Ostial system was used in 13 cases (59%). RESULTS: Mean age was 67 ± 8 years and all patients were men. The target vessel was the right coronary artery (59%), left main (27%), or a saphenous vein graft (14%); 59% of the lesions had moderate/severe calcification. The mean number of predilation balloons was 1.8 ± 1.6, mean Flash ostial balloon diameter was 3.3 ± 0.5 mm and mean inflation pressure was 13.1 ± 4.0 atmospheres. Intravascular ultrasonography (available for 19 patients) revealed mean ostial minimum lumen cross-sectional area (MLA) of 9.2 ± 3.0 mm2 and reference MLA of 8.5 ± 2.7 mm2 . The percent difference between ostial and reference MLA was higher in cases in which the Flash Ostial system was used versus those where it was not (9.6 ± 5.5% vs. 4.0 ± 2.8%, P = 0.03). All stent struts were well apposed. Technical success was 100%. One patient developed a left groin pseudoaneurysm treated with thrombin injection and one patient had a periprocedural myocardial infarction. Median contrast, fluoroscopy time, and procedure time were 235 mL, 33 min, and 118 min, respectively. CONCLUSIONS: The Flash Ostial system can be successfully used in aorto-ostial stenting, resulting in large ostial vessel MLA. © 2016 Wiley Periodicals, Inc.

Impact of crossing technique on the incidence of periprocedural myocardial infarction during chronic total occlusion percutaneous coronary intervention.

OBJECTIVES: We sought to evaluate the impact of crossing strategy on the incidence of periprocedural myocardial infarction (PMI) during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The optimal technique for crossing coronary CTOs remains controversial. METHODS: We retrospectively examined the incidence of PMI among 184 consecutive patients who underwent CTO PCI at our institution between 2012 and 2015. Creatine kinase-myocardial band fraction (CK-MB) and troponin were measured before and after PCI in all patients. PMI was defined as CK-MB increase ≥3× upper limit of normal (ULN). RESULTS: Mean age was 65 ± 8 years, 98% of patients were men, 57% had diabetes mellitus, 36% were current smokers, 38% had prior heart failure, 31% had prior coronary artery bypass graft surgery (CABG), and 55% had prior PCI. The retrograde approach was used in 38% of cases. As compared with antegrade wire escalation and antegrade dissection/re-entry, use of the retrograde approach was associated with higher J-CTO (Multicenter CTO Registry of Japan) scores (P < 0.0001), higher frequency of moderate or severe calcification (P = 0.0061), longer CTO length (P < 0.0001), more frequent proximal cap ambiguity (P < 0.0001), and lower technical (P = 0.0007) and procedural (P = 0.0014) success. The frequency of PMI for the antegrade-only and retrograde cases was 10% and 33%, respectively (P = 0.0001). On multivariate analysis, use of the retrograde approach and moderate/severe calcification were independently associated with higher incidence of PMI. CONCLUSIONS: As compared with antegrade-only crossing techniques, the retrograde approach is used in patients with more complex anatomy but may carry higher risk for PMI. © 2016 Wiley Periodicals, Inc.

Optimizing Radiation Safety in the Cardiac Catheterization Laboratory: A Practical Approach.

Reducing radiation exposure during cardiovascular catheterization is of paramount importance for both patient and staff safety. Over the years, advances in equipment and application of radiation safety protocols have significantly reduced patient dose and operator exposure. This review examines the current status of radiation protection in the cardiac and vascular catheterization laboratory and summarizes best practices for minimizing radiation exposure.

Determinants of operator and patient radiation exposure during cardiac catheterization: Insights from the RadiCure (RADIation reduction during cardiac catheterization using real-timE monitoring) trial.

BACKGROUND: In the RadiCure study 505 catheterization procedures were 1:1 randomized to use or no use of real-time radiation monitoring. Use of the Bleeper Sv monitor resulted in a significant reduction in operator radiation exposure. METHODS: We examined the association between several baseline and procedural parameters with operator and patient radiation exposure using univariable and multivariable analysis in the 505 patients that were enrolled in RadiCure. All baseline demographic and procedure characteristics recorded were included in the univariable analysis. RESULTS: Median fluoroscopy time was 6.2 (2.5-12.5) minutes, median patient air kerma dose was 0.908 (0.602-1.636) Gray and median first operator exposure was 10 (5-22) µSv. For analysis purposes, the 505 procedures were dichotomized based on the median operator exposure (10 µSv) and median patient radiation dose (0.908 Gray). On multivariable analysis, factors associated with high (above median or >10 µSv) first operator radiation exposure included radial access (odds ratio [OR] 5.44, 95% Confidence Interval [CI] 2.88-10.76), chronic total occlusion (CTO) intervention (OR 12.78, 95% CI 4.42-43.60), real-time radiation monitoring (OR 0.42, 95% CI 0.26-0.66), and use of a radioabsorbent drape (OR 0.53, 95% CI 0.28-0.96). High patient radiation dose (above median or >0.908 Gray) was associated with body mass index>30 kg/m2 (OR 3.22, 95% CI 1.99-5.29), prior MI (OR 2.26, 95% CI 1.29-4.04), prior cerebrovascular disease (OR 0.34, 95% CI 0.15-0.75), hypertension (OR 2.40, 95% CI 1.05-5.82), prior coronary artery bypass graft surgery (OR 2.46, 95% CI 1.40-4.39) and CTO intervention (OR 12.93, 95% CI 3.28-87.31), but was not associated with real-time radiation monitoring and use of a radioabsorbent drape. CONCLUSIONS: Several clinical and procedural factors are associated with higher patient and operator radiation exposure. Real-time radiation monitoring and use of disposable radiation shields were associated with lower operator, but not patient, radiation dose. © 2015 Wiley Periodicals, Inc.

Long-term outcomes with first- vs. second-generation drug-eluting stents in saphenous vein graft lesions.

BACKGROUND: As compared with bare metal stents, first-generation drug-eluting stents (DES) improved post-procedural outcomes in aortocoronary saphenous vein graft (SVG) lesions, but there is limited information on outcomes after use of second-generation DES in SVGs. METHODS: We compared the outcomes of patients who received first- (n = 81) with those who received second-generation (n = 166) DES in SVG lesions at our institution between 2006 and 2013. Major adverse cardiac events (MACE) were defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization. RESULTS: Mean age was 66.0 ± 8.1 years and 97.6% of the patients were men. Mean SVG age was 11.1 ± 0.4 years. First-generation DES were sirolimus-eluting (n = 17) and paclitaxel-eluting (n = 64) stents. Second-generation DES were everolimus-eluting (n = 115) and zotarolimus-eluting (n = 51) stents. Median follow-up was 41 months. At 2-years post-procedure, patients with first- and second-generation DES had similar rates of death (20.91% vs. 20.27%, P = 0.916), target lesion revascularization (16.39% vs. 20.00%, P = 0.572), target vessel revascularization (20.97% vs. 23.16%, P = 0.747), myocardial infarction (26.15% vs. 23.00%, P = 0.644), and MACE (43.5% vs. 40.87%, P = 0.707), respectively. CONCLUSIONS: Outcomes with first- and second-generation DES in SVGs are similar. Novel stent designs are needed to further improve the clinical outcomes in this challenging patient and lesion subgroup. © 2015 Wiley Periodicals, Inc.

Prevalence and management of coronary chronic total occlusions in a tertiary Veterans Affairs hospital.

OBJECTIVES: We sought to determine the contemporary prevalence and management of coronary chronic total occlusions (CTO) in a veteran population. BACKGROUND: The prevalence and management of CTOs in various populations has received limited study. METHODS: We collected clinical and angiographic data in consecutive patients that underwent coronary angiography at our institution between January 2011 and December 2012. Coronary artery disease (CAD) was defined as ≥50% diameter stenosis in ≥1 coronary artery. CTO was defined as total coronary artery occlusion of ≥3 month duration. RESULTS: Among 1,699 patients who underwent angiography during the study period, 20% did not have CAD, 20% had CAD and prior coronary artery bypass graft surgery (CABG), and 60% had CAD but no prior CABG. The prevalence of CTO among CAD patients with and without prior CABG was 89 and 31%, respectively. Compared to patients without CTO, CTO patients had more co-morbidities, more extensive CAD and were more frequently referred for CABG. Percutaneous coronary intervention (PCI) to any vessel was performed with similar frequency in patients with and without CTO (50% vs. 53%). CTO PCI was performed in 30% of patients without and 15% of patients with prior CABG with high technical (82 and 75%, respectively) and procedural success rates (80 and 73%, respectively). CONCLUSIONS: In a contemporary veteran population, coronary CTOs are highly prevalent and are associated with more extensive co-morbidities and higher likelihood for CABG referral. PCI was equally likely to be performed in patients with and without CTO.

Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial.

BACKGROUND: We sought to evaluate the contemporary use of embolic protection devices (EPDs) in saphenous vein graft (SVG) interventions. METHODS: We examined EPD use in the stenting of saphenous vein grafts (SOS) trial, in which 80 patients with 112 lesions in 88 SVGs were randomized to a bare metal stent (39 patients, 43 grafts, and 55 lesions) or paclitaxel-eluting stent (41 patients, 45 grafts, and 57 lesions). RESULTS: An EPD was used in 60 of 112 lesions (54%). A Filterwire (Boston Scientific) was used in 70% of EPD-treated lesions, Spider (ev3, Plymouth, Minnesota) in 12%, Proxis (St. Jude, Minneapolis, Minnesota) in 12%, and Guardwire (Medtronic, Santa Rosa, California) in 7%. Of the remaining 52 lesions, an EPD was not utilized in 13 lesions (25%) because the lesion was near the distal anastomosis, in 14 lesions (27%) because of an ostial location, in one lesion (2%) because of small SVG size, in two in-stent restenosis lesions (4%) because of low distal embolization risk, and in 22 lesions (42%) because of operator's preference even though use of an EPD was feasible. Procedural success was achieved in 77 patients (96%); in one patient a Filterwire was entrapped requiring emergency coronary bypass graft surgery and two patients had acute stent thrombosis. CONCLUSION: In spite of their proven efficacy, EPDs were utilized in approximately half of SVG interventions in the SOS trial. Availability of a proximal protection device could allow protection of approximately 25% of unprotected lesions, yet operator discretion appears to be the major determinant of EPD use.

A Randomized Controlled Trial of Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis.

OBJECTIVES: To test whether administration of prasugrel after coronary artery bypass grafting (CABG) reduces saphenous vein graft (SVG) thrombosis. Use of aspirin after CABG improves graft patency, but administration of other antiplatelet agents has yielded equivocal results. METHODS: We performed a double-blind trial randomizing patients to prasugrel or placebo after CABG at four United States centers. Almost all patients were receiving aspirin. Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS) were performed at 12 months. The primary efficacy endpoint was prevalence of OCT-detected SVG thrombus. The primary safety endpoint was incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding. RESULTS: The study was stopped early due to slow enrollment after randomizing 84 patients. Mean age was 64 ± 6 years; 98% of the patients were men. Follow-up angiography was performed in 59 patients. IVUS was performed in 52 patients, OCT in 53 patients, and NIRS in 33 patients. Thrombus was identified by OCT in 56% vs 50% of patients in the prasugrel vs placebo groups, respectively (P=.78). Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19). The 1-year incidence of major adverse cardiovascular events was 14.3% vs 2.4% in the prasugrel and placebo groups, respectively (P=.20), without significant differences in GUSTO severe bleeding (P=.32). CONCLUSION: Early SVG failure occurred in approximately one-third of patients. Prasugrel did not decrease prevalence of SVG thrombus 12 months after CABG.

Prior coronary artery bypass graft surgery patients undergoing diagnostic coronary angiography have multiple uncontrolled coronary artery disease risk factors and high risk for cardiovascular events.

Limited contemporary data exist on the cardiovascular risk of patients with prior coronary artery bypass grafting surgery (CABG) requiring diagnostic coronary angiography. We examined the prevalence and control of coronary artery disease risk factors and the outcomes of 367 prior CABG patients who underwent diagnostic coronary angiography between October 1, 2004 and May 31, 2007 at the Dallas Veterans Affairs Medical Center. Mean age was 65 +/- 9 years, 97% were men, and the mean time from CABG to diagnostic angiography was 8.2 +/- 6.1 years. Hypertension, low-density lipoprotein cholesterol, diabetes mellitus, smoking, and obesity were suboptimally controlled in 70%, 59%, 47%, 33%, and 50%, respectively. Intake of statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers was 88% and 81%, respectively. After a mean follow-up of 1.4 +/- 0.8 years, the incidence of death and major cardiovascular events was 10% and 32%, respectively. In spite of significant improvement compared to previous studies and good compliance with indicated medications, contemporary prior CABG patients undergoing coronary angiography still have multiple and poorly controlled coronary artery disease risk factors and high risk for cardiovascular events. Novel pharmacologic and behavioral treatment strategies are needed.

Impact on contrast, fluoroscopy, and catheter utilization from knowing the coronary artery bypass graft anatomy before diagnostic coronary angiography.

To what extent the unavailability of coronary artery bypass graft (CABG) anatomy complicates the performance of diagnostic coronary angiography has not been studied. The medical and catheterization records and coronary angiograms of 367 consecutive CABG surgery patients who underwent 394 diagnostic coronary angiographic studies from October 1, 2004, to May 31, 2007, were retrospectively reviewed. The patients' mean age was 65+/-9 years, and 97% were men. The mean interval from CABG surgery to angiography was 8.3+/-6.1 years. Patent left internal mammary artery grafts were found in 75%, and the mean number of patent grafts was 2.1+/-1.0. Compared with angiograms with known CABG anatomy, angiograms with unknown CABG anatomy (26%) required significantly higher amounts of contrast (189+/-7 vs 158+/-4 ml), longer fluoroscopy times (14.0+/-0.7 vs 10.6+/-0.4 minutes), and more diagnostic catheters (3.0+/-0.1 vs 2.5+/-0.05) (p<0.001 for all comparisons). The unavailability of CABG anatomy remained associated with increased contrast, fluoroscopy, and catheter use after multivariate adjustment. Proximal anastomotic bypass markers were associated with lower contrast use but were seen in only 9% of patients. In conclusion, the unavailability of CABG anatomy significantly and independently increases the use of contrast, fluoroscopy, and catheters during diagnostic coronary angiography. Every effort should be made to obtain CABG anatomy before diagnostic angiography is performed.

Perioperative risk of patients undergoing noncardiac surgery after coronary artery bypass surgery.

BACKGROUND: Most data suggesting that noncardiac surgery early after coronary artery bypass surgery carries low risk are derived from post hoc analyses of randomized controlled trials, with only limited data derived from contemporary, nonselected, and nontrial patients. METHODS: We retrospectively reviewed the medical records of patients who underwent coronary artery bypass surgery at our institution between January 1999 and October 2006 to determine whether they subsequently had major noncardiac surgery and what the outcomes of the noncardiac surgery were. RESULTS: During the study period, 1065 patients underwent coronary artery bypass surgery, and 272 (26%) subsequently underwent 467 major noncardiac surgeries. The mean interval from coronary artery bypass to noncardiac surgery was 1.9 +/- 1.9 years (range, 0-7.8 years). A major complication occurred in 3 surgeries (0.6% [95% confidence interval, 0.1%-1.9%]). Two patients died (both from respiratory arrest during the postoperative period: 1 patient had a tongue cancer excision, and the other patient had polycythemia vera), and the third patient had a perioperative arrhythmia. CONCLUSIONS: Noncardiac surgery is often required early after coronary artery bypass surgery and carries very low risk for cardiac complications, suggesting that preoperative cardiac evaluation may not be required in most such patients.

Recurrent late drug-eluting stent thrombosis upon discontinuation of antiplatelet therapy.

Stent thrombosis is a rare but serious complication of percutaneous coronary intervention. Stent thrombosis usually occurs early after stent implantation but can occasionally occur late, especially when drug-eluting stents are used. We report a case of recurrent late paclitaxel-eluting stent thrombosis (8 and 21 months after initial stent implantation) upon discontinuation of dual antiplatelet therapy.

Reproducibility of intravascular ultrasound virtual histology analysis.

OBJECTIVE: Intravascular ultrasound with virtual histology analysis (IVUS-VH) is a novel technology which allows for the identification of discrete atherosclerotic plaque components using radiofrequency backscatter data. Whether the composition of these plaques can be monitored accurately in a longitudinal fashion remains unclear. We sought to evaluate the reproducibility of plaque composition measurements as determined by IVUS-VH in a clinical setting. METHODS: Sixteen consecutive patients who underwent percutaneous coronary intervention were included in this study. Prior to and then again following intervention, IVUS images with VH processing were obtained with motorized pullback. Up to 4 frames were selected for analysis for each patient, with a total of 24 IVUS frames used. An IVUS frame was chosen with visible angiographic and ultrasound landmarks. The matching frame on the second pullback was identified using these landmarks. For each frame, vessel and lumen area as well as plaque composition by VH were determined. RESULTS: There was a high level of agreement between the two pullback measurements for lumen area, vessel area, and plaque burden (the Spearman rank-order correlation coefficients were 0.96, 0.96, and 0.95, respectively). Similarly, for plaque components by VH, the coefficients ranged from .90 to .97 and 0.84 to 0.92 for segmental volumetric analysis. The Bland-Altman plots indicated proportional error for the differences of the four measurements between the two pullback trials and were associated with high coefficients of reproducibility. CONCLUSIONS: Discrete measurements of plaque compositional area and volume in the clinical setting appear to have reproducibility comparable to that of traditional IVUS measurements.

Contemporary Use of Laser During Percutaneous Coronary Interventions: Insights from the Laser Veterans Affairs (LAVA) Multicenter Registry.

BACKGROUND: The contemporary use and outcomes of excimer laser coronary atherectomy (ELCA) in percutaneous coronary intervention (PCI) are not well described. METHODS: We examined the baseline clinical and angiographic characteristics and procedural outcomes of 130 target lesions in 121 consecutive PCIs (n = 116 patients) in which ELCA was performed at three United States Department of Veterans Affairs (VA) medical centers between 2008 and 2016. RESULTS: Mean age was 68.5 ± 9 years and 97% of the patients were men. Patients had high prevalence of diabetes mellitus (63%), prior coronary artery bypass graft surgery (41%), and prior myocardial infarction (60%). The most common target vessel was the left anterior descending (32%), followed by the right coronary artery (30%), circumflex artery (20%), and saphenous vein graft (12%). The target lesions were highly complex, with moderate/severe calcification in 62% and in-stent restenosis in 37%. The most common indication for ELCA was balloon-uncrossable lesions (43.8%), followed by balloon-undilatable lesions (40.8%) and thrombotic lesions (12.3%). Use of ELCA was associated with high technical success rate (90.0%) and procedural success rate (88.8%), and low major adverse cardiac event (MACE) rate (3.45%). Mean procedure time was 120 min (interquartile range [IQR], 81-191 min), air kerma radiation dose was 2.76 Gy (IQR, 1.32-5.01 Gy), and contrast volume was 273 mL (IQR, 201-362 mL). CONCLUSION: In a contemporary multicenter United States registry, ELCA was commonly used in highly complex lesions and was associated with high technical and procedural success rates and low incidence of MACE.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.

A Meta-Analysis of Contemporary Lesion Modification Strategies During Percutaneous Coronary Intervention in 244,795 Patients From 22 Studies.

OBJECTIVES: Outcomes with use of lesion-modification strategies in the drug-eluting stent era have received limited study. METHODS: We conducted a meta-analysis of 22 studies published between 2004-2016 reporting outcomes after use of rotational atherectomy, cutting-balloon, and scoring-balloon angioplasty. RESULTS: In observational trials, acute luminal gain was higher after lesion modification as compared with control (standardized mean difference, 0.23 mm; 95% confidence interval [CI], 0.01-0.44; P=.04), with no difference in acute gain in randomized studies. Compared with control, lesion modification was associated with lower restenosis in randomized trials (odds ratio [OR], 0.64; 95% CI, 0.45-0.90; P=.01). Ninety-day incidence of major adverse cardiovascular event (MACE) was higher after lesion modification in observational studies (OR, 1.39; 95% CI, 1.05-1.83; P=.02), but similar in randomized trials. Ninety-day incidence of target-lesion or target-vessel revascularization (TLR-TVR) and myocardial infarction (MI) was similar. Ninety-day incidence of death was higher after lesion modification in observational studies (OR, 1.42; 95% CI, 1.04-1.95; P=.03), but similar in randomized trials. At 1 year, the MACE rate was similar for lesion modification compared with control in observational studies, but lower after lesion modification in randomized trials (OR, 0.65; 95% CI, 0.48-0.88; P<.01). TLR-TVR was higher with lesion modification in observational studies, but lower in randomized trials (OR, 0.64; 95% CI, 0.46-0.88; P<.01). CONCLUSIONS: While observational studies suggest a higher early MACE rate and more restenosis, randomized trials show similar short-term and improved long-term outcomes with pre-stenting lesion modification compared with control.

Percutaneous Coronary Intervention of Coronary Chronic Total Occlusions Improves Peak Oxygen Uptake During Cardiopulmonary Exercise Testing.

OBJECTIVES: Although coronary chronic total occlusions (CTOs) are treated with percutaneous coronary intervention (PCI) to improve symptoms, studies demonstrating symptom improvement have been mostly limited to questionnaire responses. The current study assessed for changes in peak oxygen uptake during cardiopulmonary exercise testing after CTO-PCI. METHODS: Patients with heart failure or angina symptoms referred for CTO-PCI were prospectively enrolled. The primary outcome of the study was improvement in peak oxygen uptake during cardiopulmonary exercise (CPX) testing 5 months after CTO-PCI. Secondary outcomes included improvement in physical capacity, angina, and self perception of health as assessed by questionnaires, and in plasma brain natriuretic peptide (BNP) levels. RESULTS: CTO-PCI was attempted in 32 men (mean age, 62 ± 6 years; CTO vessel: 47% right coronary, 44% left anterior descending). CTO-PCI was unsuccessful in 1 patient, and 3 patients had restenosis of their CTO vessel at follow-up. In the 28 patients with patent CTO vessel at follow-up, significant improvements were noted in self-reported physical capacity, angina, and several aspects of health perception. In the 25 patients who underwent baseline and follow-up CPX testing, peak oxygen uptake significantly improved from 17.7 ± 4.3 mL/kg/min to 19.1 ± 4.0 mL/kg/min (P=.02). Plasma BNP levels significantly decreased from 143 ± 138 pg/mL to 102 ± 123 pg/mL (P=.01). CONCLUSIONS: CTO-PCI in symptomatic patients was associated with improvements in cardiovascular exercise capacity, as assessed by peak oxygen uptake. These results suggest that in symptomatic patients with CTOs, PCI appears clinically beneficial.

Effect of PCSK9 Inhibitors on Clinical Outcomes in Patients With Hypercholesterolemia: A Meta-Analysis of 35 Randomized Controlled Trials.

BACKGROUND: We sought to examine the efficacy and safety of 2 PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors: alirocumab and evolocumab. METHODS AND RESULTS: We performed a systematic review and meta-analysis of randomized controlled trials comparing treatment with and without PCSK9 inhibitors; 35 randomized controlled trials comprising 45 539 patients (mean follow-up: 85.5 weeks) were included. Mean age was 61.0±2.8 years, and mean baseline low-density lipoprotein cholesterol was 106±22 mg/dL. Compared with no PCSK9 inhibitor therapy, treatment with a PCSK9 inhibitor was associated with a lower rate of myocardial infarction (2.3% versus 3.6%; odds ratio [OR]: 0.72 [95% confidence interval (CI), 0.64-0.81]; P<0.001), stroke (1.0% versus 1.4%; OR: 0.80 [95% CI, 0.67-0.96]; P=0.02), and coronary revascularization (4.2% versus 5.8%; OR: 0.78 [95% CI, 0.71-0.86]; P<0.001). Overall, no significant change was observed in all-cause mortality (OR: 0.71 [95% CI, 0.47-1.09]; P=0.12) or cardiovascular mortality (OR: 1.01 [95% CI, 0.85-1.19]; P=0.95). A significant association was observed between higher baseline low-density lipoprotein cholesterol and benefit in all-cause mortality (P=0.038). No significant change was observed in neurocognitive adverse events (OR: 1.12 [95% CI, 0.88-1.42]; P=0.37), myalgia (OR: 0.95 [95% CI, 0.75-1.20]; P=0.65), new onset or worsening of preexisting diabetes mellitus (OR: 1.05 [95% CI, 0.95-1.17]; P=0.32), and increase in levels of creatine kinase (OR: 0.84 [95% CI, 0.70-1.01]; P=0.06) or alanine or aspartate aminotransferase (OR: 0.96 [95% CI, 0.82-1.12]; P=0.61). CONCLUSIONS: Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes. Although no overall benefit was noted in all-cause or cardiovascular mortality, such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol.