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.

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.

Association of coronary lipid core plaque with intrastent thrombus formation: a near-infrared spectroscopy and optical coherence tomography study.

BACKGROUND: Optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) allow assessment of the anatomy (OCT) and composition (NIRS) of coronary lesions. We sought to examine the association between pre-stenting lipid core plaque (LCP), as assessed by NIRS and post-stenting thrombus formation, as assessed by OCT. METHODS: We reviewed the angiograms of nine patients who underwent coronary stenting in association with NIRS and OCT imaging. A large LCP by NIRS was defined as at least three 2-mm yellow blocks on the NIRS block chemogram with >200° angular extent. Intracoronary thrombus was defined as a mass of medium reflectivity protruding into the vessel lumen, discontinuous from the surface of the vessel wall. RESULTS: Mean age was 67 ± 7 years, and all patients were men, presenting with stable angina (56%), unstable angina (11%), or acute myocardial infarction (33%). The mean vessel lipid core burden index (LCBI) was 120 ± 45, and the mean highest 6-mm LCBI was 386 ± 190. Three patients had a large LCP and two of them (66%) developed intrastent thrombus after stent implantation compared to none of six patients without large LCPs (0%, P = 0.02). The thrombus resolved after intracoronary glycoprotein IIb/IIIa administration and balloon postdilation. Postprocedural myocardial infarction occurred in 33% versus 17% of patients with and without large LCP, respectively (P = 0.57). CONCLUSION: Stenting of large LCPs may be associated with intrastent thrombus formation, suggesting that more intensive anticoagulant and/or antiplatelet therapy may be beneficial in such lesions. © 2012 Wiley Periodicals, Inc.

Role of embolic protection devices in ostial saphenous vein graft lesions.

BACKGROUND: Although embolic protection devices (EPDs) have been shown to be beneficial in saphenous vein graft (SVG) lesions, their role in the subgroup of ostial SVG lesions has received limited study. METHODS: The coronary angiograms and procedural outcomes of 109 patients undergoing stenting of 113 ostial SVG lesions were retrospectively reviewed to determine the frequency of EPD use and the periprocedural outcomes. RESULTS: Ninety-eight (87%) of the 113 lesions were suitable for EPD use, that was used in 70 lesions (71%). A Filterwire (Boston Scientific) or a SPIDER (ev3) filter were used in 54 (77%) and 16 (23%) of lesions, respectively. Difficulty retrieving the filter post stenting was encountered in eight lesions (11%) and led to stent thrombosis causing cardiac arrest in one patient (1%). Angiographic success was achieved in 111 (98%) of 113 lesions. CONCLUSIONS: EPDs can be utilized in the majority of ostial SVG lesions, but in 11% of cases filter retrieval can be challenging and may rarely (in approximately 1%) lead to a significant complication.

Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study.

BACKGROUND: The Radiation Reduction During Cardiac Catheterization Using Real-Time Monitoring study sought to examine the effect of a radiation detection device that provides real-time operator dose reporting through auditory feedback (Bleeper Sv; Vertec Scientific Ltd; Berkshire, UK) on patient dose and operator exposure during cardiac catheterization. METHODS AND RESULTS: Between January 2012 and May 2014, 505 patients undergoing coronary angiography, percutaneous coronary intervention, or both were randomized to use (n=253) or no use (n=252) of the Bleeper Sv radiation monitor. Operator radiation exposure was measured in both groups using a second, silent radiation exposure monitoring device. Mean patient age was 65±8 years, most patients (99%) were men, and 30% had prior coronary artery bypass graft surgery. Baseline clinical characteristics were similar in the 2 study groups. Radial access was used in 18% and chronic total occlusion percutaneous coronary intervention constituted 7% of the total procedures. Median procedure time was 17 (12-27) minutes for diagnostic angiography, 42 (28-70) minutes for percutaneous coronary intervention, and 27 (14-51) minutes in the overall study population, with similar distribution between the study groups. First (9 [4-17] versus 14 [7-25] µSv; P<0.001) and second (5 [2-10] versus 7 [4-14] µSv; P<0.001) operator radiation exposure was significantly lower in the Bleeper Sv group. Use of the device did not result in a significant reduction in patient radiation dose. The effect of the Bleeper Sv device on operator radiation exposure was consistent among various study subgroups. CONCLUSIONS: Use of a real-time radiation monitoring device that provides auditory feedback can significantly reduce operator radiation exposure during cardiac catheterization. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01510353.

Prevalence and outcomes of intermediate saphenous vein graft lesions: findings from the stenting of saphenous vein grafts randomized-controlled trial.

BACKGROUND: We sought to examine the prevalence and progression rate of intermediate saphenous vein graft (SVG) lesions in the Stenting Of Saphenous vein grafts (SOS) trial. METHODS: The baseline and follow-up angiograms of 80 patients participating in the SOS trial were analyzed to determine the prevalence of intermediate (30-60% angiographic diameter stenosis) SVG lesions and their progression rate. RESULTS: At least one intermediate SVG lesion was present in 31 of 143 (22%) SVGs in 27 of 80 (34%) patients. Most intermediate lesions were present in the SOS stented SVGs (20 grafts in 19 patients). During a median follow-up of 35 months, angiographic follow-up was available for 28 grafts in 25 patients. Progression (defined as percent diameter stenosis ≥ 70% but <100% at follow-up angiography) was seen in 11 of 28 SVGs (39%) in 11 of 25 patients (44%). Progression rate at 12, 24 and 36 months was 28% and 47% and 84%, respectively. Seven of 11 patients (64%) with intermediate SVG lesion progression presented with an acute coronary syndrome and 8 (73%) underwent PCI. Four of the 28 grafts with intermediate lesions at baseline were 100% occluded at follow-up; all of those SVGs had received a stent in another location in the SVG as part of the SOS trial. CONCLUSIONS: Intermediate SVG lesions are common in patients undergoing SVG stenting, have high rates of progression and frequently present with an acute coronary syndrome. Further study of pharmacologic and mechanical treatments to prevent progression of these lesions is needed.

Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions.

OBJECTIVES: The Stenting of Saphenous Grafts-Xience V (SOS-Xience V) trial prospectively examined the frequency of angiographic in-stent restenosis in saphenous vein graft (SVG) lesions 12 months after implantation of a Xience V everolimus-eluting stent (EES; Abbott Vascular). Optical coherence tomography (OCT) during follow-up angiography was added to the protocol after OCT was approved for clinical use in the United States. METHODS: Forty patients with 40 SVG lesions were enrolled in the study, of whom 27 underwent 12-month coronary angiography and 12 (only 1 of whom had in-stent restenosis) also had follow-up OCT evaluation. OCT strut-level analysis was performed to determine the percentage of strut coverage, malapposition, strut protrusion, neointimal thickness, and the existence of thrombus. RESULTS: Mean patient age was 67 ± 7 years, and 95% were men. A total of 2584 struts were evaluated by OCT. The percentages for uncovered, malapposed, and protruding struts were 4%, 9%, and 15%, respectively. The mean strut neointimal thickness was 0.094 ± 0.094 mm. Of the 12 stents analyzed, 4 (33%) showed full neointimal coverage, 2 (17%) had all the struts embedded, 7 (58%) had at least 1 malapposed strut, and 10 (83%) had at least 1 protruding strut. The mean difference between the stent area and the lumen area was 0.36 ± 1.6 mm². No thrombus was detected in the stented areas. CONCLUSIONS: Use of EES in SVGs is associated with high rates of stent strut coverage and high malapposition rates at 12 months post implantation.

Incidence and Treatment of Arterial Access Dissections Occurring during Cardiac Catheterization.

BACKGROUND: Arterial access dissections may complicate cardiac catheterization and can often be treated percutaneously. The goal of this study was to examine the incidence, consequences, and the treatment of arterial access dissections at a tertiary referral hospital with an active training program. METHODS: Patients experiencing arterial access dissection during coronary angiography or intervention at our institution between October 1, 2004, and January 31, 2007, were identified and their records were retrospectively reviewed. RESULTS: Thirteen of the 3,062 consecutive patients (0.42%) had arterial access dissection during the study period. The location of the dissection was in the common femoral artery (CFA) (n = 6), the external iliac artery (EIA) (n = 6), or in an aortobifemoral graft (n = 1). Three of the six patients with CFA dissection were diagnosed during coronary angiography, and because of significant comorbidities were treated with self-expanding stents. After a mean follow-up of 7 months, they experienced no stent fracture or other complication. Six patients had EIA dissections. In one such patient, the dissection was not flow limiting and was treated conservatively. The remaining five patients underwent successful implantation of self-expanding stents, and during a mean follow-up of 9.6 months, no patient had any symptoms or events related to lower extremity ischemia. Finally, one patient had an aortobifemoral graft dissection. Due to the patient's critical condition, secondary to sepsis, his family elected to withdraw care, and he subsequently expired. CONCLUSIONS: Arterial access dissections occur infrequently during cardiac catheterization. Routine femoral artery angiography may help identify vascular access complications, often allowing simultaneous endovascular treatment, with excellent short-term outcomes.