Nine-month results of the BIOHELIX-I clinical trial study: Evaluation of the PRO-Kinetic Energy cobalt chromium bare-metal stent system.

OBJECTIVES: To evaluate the safety and efficacy of the PRO-Kinetic Energy (PKE) Cobalt Chromium Coronary Stent System (BIOTRONIK AG, Switzerland). BACKGROUND: Percutaneous coronary intervention is a mainstay treatment for symptomatic coronary artery disease (CAD). While drug-eluting stents constitute a majority of implants, bare-metal stents (BMS) remain important for a subset of patients. Newer generation BMS offer advantages due to stent design improvements. METHODS: The BIOHELIX-I study was a prospective, multicenter, non-randomized, single arm clinical trial designed to evaluate the safety and efficacy of the PKE bare metal stent. Thirty-three study centers (US, Columbia, Europe) enrolled 329 patients for treatment of one target lesion (≤31 mm). Eligible patients received a PKE stent(s), at least one month of dual antiplatelet therapy and were followed for 36-months. The primary endpoint was the 9-month rate of target vessel failure (TVF) compared with a prespecified performance goal of 18.7% derived from prior BMS trials. RESULTS: The mean patient age was 69 years, 28.6% with diabetes. The mean lesion length was 13.7 ± 6.0 mm. The 9-month TVF rate was 9.06% and met the primary endpoint (P < 0.001). The TVF component rates were 0.95% cardiac death, 1.58% myocardial infarction, and 7.26% ischemia-driven target vessel revascularization (TVR). The ischemia-driven target lesion revascularization rate at 9-months was 6.62%. CONCLUSIONS: The 9-month TVF rate of the PKE stent was comparable to other BMS and is a viable option for treating CAD. The low observed rate of ischemia-driven TVR supports the safety and efficacy of the novel BMS design.

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.

Temporal trends of fluoroscopy time and contrast utilization in coronary chronic total occlusion revascularization: insights from a multicenter United States registry.

BACKGROUND: The impact of operator experience on fluoroscopy time and contrast utilization during percutaneous coronary intervention (PCI) of coronary chronic total occlusions (CTOs) has received limited study. METHODS: We evaluated temporal trends in fluoroscopy time and contrast utilization among 1,363 consecutive CTO PCIs performed at three US institutions between January 2006 and November 2011. RESULTS: Mean age was 65 ± 11 years, 85% of patients were men, 40% had diabetes, 37% had prior coronary artery bypass graft surgery, and 42% had prior PCI. The CTO target vessel was the right coronary artery (55%), circumflex (23%), left anterior descending artery (21%), and left main or bypass graft (1%). The retrograde approach was used in 34% of all procedures. The technical and procedural success rates were 85.5 and 84.2%, respectively. The mean procedural time, fluoroscopy time, and contrast utilization were 113 ± 61 min, 42 ± 29 min, and 294 ± 158 mL, respectively. Years since initiation of CTO PCI were independently associated with higher technical success rate (odds ratio [OR] = 1.52, 95% confidence interval [CI] = 1.52-1.70, P < 0.001), lower fluoroscopy time (OR = 0.84, 95% CI = 0.75-0.95, P = 0.005), and contrast utilization (OR = 0.84, 95% CI = 0.62-0.79, P < 0.001) during the study period. CONCLUSIONS: Among selected US-based institutions performing CTO PCI, we observed a significant reduction in total fluoroscopy time and contrast utilization paralleled with an improved technical success rate over time.

Frequency and outcomes of aortocoronary dissection during percutaneous coronary intervention of chronic total occlusions: a case series and systematic review of the literature.

BACKGROUND: Aortocoronary dissection can complicate percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). METHODS: We retrospectively examined the frequency and outcomes of aortocoronary dissection among 336 consecutive CTO PCIs performed at our institution between 2005 and 2012 and performed a systematic review of the published literature. RESULTS: Aortocoronary dissection occurred in six patients (1.8%, 95% confidence intervals 0.7%, 3.8%). All aortocoronary dissections occurred in the right coronary artery (CTO target vessel in five patients and donor vessel in one patient). The baseline clinical characteristics of patients with and without aortocoronary dissection were similar. Compared to patients without, those with aortocoronary dissection were more likely to undergo crossing attempts using the retrograde approach (25% vs. 67%, P = 0.036) and experience a major complication (2.4% vs. 33.3%, P = 0.008). Technical and procedural success rates were similar in both groups. Of the six patients with aortocoronary dissection one underwent emergency coronary bypass graft surgery (CABG), four were treated with ostial stenting, and one was treated conservatively without subsequent adverse clinical outcomes. Systematic literature review provided 107 published cases of aortocoronary dissection during PCI, that occurred mainly in the right coronary artery (74.8%) and were treated with stenting (49.5%), emergency CABG (29%), or conservatively (21.5%). CONCLUSIONS: Aortocoronary dissection is an infrequent complication of CTO PCI and although it can be treated with stents in most patients, it may infrequently require emergency CABG.

Low molecular weight dextran provides similar optical coherence tomography coronary imaging compared to radiographic contrast media.

BACKGROUND: Optical coherence tomography (OCT) coronary imaging requires displacement of red blood cells from the vessel lumen. This is usually accomplished using radiographic contrast. Low molecular weight dextran has low cost and is safe in low volumes. In the present study, we compared dextran with contrast for coronary OCT imaging. METHODS: Fifty-one vessels in 26 patients were sequentially imaged using manual injection of radiographic contrast (iodixanol) and dextran. OCT images were analyzed at 1 mm intervals to determine the image clarity (defined as a visible lumen border > 270°) and to measure the lumen area and lumen diameter. To correct for the refractive index of dextran, the dextran area measurements were multiplied by 1.117 and the dextran length measurements were multiplied by 1.057. RESULTS: A total of 3,418 cross-sections (1,709 with contrast and 1,709 with dextran) were analyzed. There were no complications related to OCT imaging or to contrast or dextran administration. Clear image segments were observed in 97.0% vs. 96.7% of the cross-sections obtained with contrast and dextran, respectively (P = 0.45). The mean lumen areas were also similar: 6.69 ± 1.95 mm(2) with iodixanol vs. 7.06 ± 2.06 mm(2) with dextran (correlation coefficient 0.984). CONCLUSIONS: The image quality and measurements during OCT image acquisition are similar for dextran and contrast. Dextran could be used instead of contrast for OCT imaging, especially in patients in whom contrast load minimization is desired.

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.

Impact of contrast agent viscosity on coronary balloon deflation times: bench testing results.

OBJECTIVES: To assess the impact of viscosity on angioplasty balloon deflation times. BACKGROUND: Lower contrast viscosity could result in more rapid coronary balloon deflation times. METHODS: We performed a bench comparison of coronary balloon deflation times using 2 contrast agents with different viscosity (ioxaglate and iodixanol), 3 contrast dilutions, and 2 inflation syringe filling volumes. Ten identical pairs of coronary angioplasty balloons were used to conduct each comparison after balloon inflation to 12 atmospheres. Simultaneous deflations were performed under cineangiography. The time to full contrast extraction and the area of contrast remaining after 5 seconds of deflation (quantified by opaque pixel count) were compared between groups. RESULTS: The mean time to full contrast extraction during balloon deflation was 8.3 ± 2.5 seconds for ioxaglate (lower viscosity) versus 10.1 ± 2.9 seconds for iodixanol (higher viscosity) (17.4% decrease, P = 0.005), with a 35.6% (P = 0.004) reduction in contrast area at 5 seconds. Compared to 1:1 ioxaglate-saline mixture, 1:2 and 1:3 ioxaglate/saline mixes resulted in 26.7% (P < 0.001) and 39.0% (P < 0.001) reduction in mean balloon deflation time, respectively, but at the expense of decreased balloon opacity. Filling the inflation syringe with 5 versus 15 ml of contrast/saline solution was associated with 7.5% decrease in balloon deflation time (P = 0.005), but no difference in contrast area at 5 seconds (P = 0.749). CONCLUSIONS: Use of a lower viscosity contrast agent and higher contrast dilution significantly reduced coronary balloon deflation times, whereas use of lower syringe filling volume had a modest effect. Rapid coronary balloon deflation could improve the safety of interventional procedures.

Long-term outcomes of successful chronic total occlusion percutaneous coronary interventions using the antegrade and retrograde approach.

OBJECTIVE: To compare long-term clinical outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the retrograde and antegrade approach. BACKGROUND: There is limited long-term clinical outcomes data on the retrograde approach to CTO PCI. METHODS: We performed a retrospective analysis of the long-term clinical outcomes of 193 consecutive patients who underwent successful CTO PCI at our institution between March 2008 and December 2011. RESULTS: Mean age was 63.6 ± 8.3 years. The target vessel was right coronary artery in 52.6%, left anterior descending artery in 24.5% and circumflex in 21.4% of cases. The retrograde approach was used in 41 patients (21.2%). The mean stent length was longer in the retrograde group (83 ± 32 vs. 64 ± 32 mm, P = 0.001). Two major procedural complications occurred, both in the retrograde group (P = 0.012). During a median follow-up of 2.0 years compared to the antegrade CTO PCI group, patients who underwent retrograde CTO PCI were more likely to undergo target lesion revascularization (TLR) (45.6% vs. 25.7%, P = 0.006). No significant difference was observed in the incidence of all-cause mortality, myocardial infarction, non-target vessel revascularization, or coronary artery bypass graft surgery between the 2 groups. On multivariate analysis, stent length was the only independent predictor of TLR during follow-up. CONCLUSIONS: Retrograde CTO PCI was associated with higher incidence of TLR, but similar incidence of death and myocardial infarction compared to antegrade CTO PCI. These findings likely reflect the higher complexity of CTO lesions treated with the retrograde approach.

Application of the "hybrid approach" to chronic total occlusion interventions: a detailed procedural analysis.

OBJECTIVE: To assess the outcomes of the "hybrid" approach to chronic total occlusion (CTO) percutaneous coronary interventions (PCIs). BACKGROUND: The "hybrid approach" to CTO PCI advocates appropriate and early change of crossing strategy to maximize success, safety, and efficiency. METHODS: We prospectively recorded and analyzed detailed step-by-step procedural data in 73 consecutive CTO PCI cases performed by a single operator between July 2011 and August 2012. RESULTS: Technical success was achieved in 66 of 73 cases (90.4%). Mean patient age was 65 ± 7 years, and 30% had prior coronary artery bypass surgery. Dual injection was used in 78%. The primary approach was retrograde in 9 cases (12.5%) and antegrade in 64 cases (87.5%), of whom 25 cases (39.1%) underwent retrograde attempt after failed antegrade approach. The initial crossing approach was successful in 40 cases (54.8%), but 32 cases (44%) required 3.6 ± 1.4 approach changes (range 2-7). Antegrade wire escalation, antegrade dissection/reentry, and retrograde crossing were utilized in 97.2%, 46.6%, and 46.6% of cases, respectively. Among successful cases, the final CTO crossing technique was antegrade wire escalation in 50.0%, antegrade dissection/reentry in 24.2%, and retrograde in 25.8%. The mean procedure time, fluoroscopy time, and air kerma radiation exposure until CTO crossing or stopping the procedure were 66 ± 55 minutes, 25 ± 23 minutes, and 2.3 ± 1.9 Gray, respectively. Three patients (4.1%) had a major complication. CONCLUSION: In the "hybrid approach" to CTO PCI, changes in crossing strategy were needed in approximately half the cases, resulting in high success and low complication rates.

Embolic protection device utilization during stenting of native coronary artery lesions with large lipid core plaques as detected by near-infrared spectroscopy.

BACKGROUND: Stenting of large lipid core plaques (LCPs), as assessed by near-infrared spectroscopy (NIRS), has been associated with periprocedural myocardial infarction (MI), possibly due to distal embolization. METHODS: An embolic protection device (EPD) was inserted before stenting in nine native coronary arteries with large LCP, as assessed by NIRS. Embolized material was assessed by histopathology. RESULTS: Mean age was 64 ± 7 years and all patients were men. The target lesion was located in the right (67%) or left anterior descending (33%) coronary artery. A filter was utilized in eight patients (89%) and proximal embolic protection in one (11%). In one patient two filters were required because the originally placed filter became obstructed with debris after initial stent placement. The mean percent angiographic stenosis prestenting and poststenting was 87% ± 9% and 2% ± 4%, respectively and final TIMI 3 flow was achieved in all patients. Embolized material was retrieved in eight of nine patients (89%) and consisted mainly of platelet and fibrin thrombi. The mean target segment lipid core burden index decreased from 395 ± 114 before stenting to 152 ± 106 after stenting (P < 0.001) and the lesion angular extent decreased from 312° ± 70° to 240° ± 90° (P = 0.07). Postprocedural MI occurred in two of nine patients (22%), in one of whom two filters were required. CONCLUSION: Use of EPDs frequently resulted in embolized material retrieval after stenting of native coronary artery lesions with large LCPs. These findings support further study of EPDs as a means to prevent poststenting MI.

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.

Subclavian artery intervention with vertebral embolic protection.

Knowing the location of the vertebral and the internal mammary artery ostia is crucial during proximal subclavian artery percutaneous intervention to prevent inadvertent injury to either artery. We report a case of severe proximal left subclavian artery stenosis in a patient with a three-vessel disease referred to coronary artery bypass graft surgery. Retrograde angiography via left radial access allowed visualization of the left internal mammary artery and the left vertebral artery ostia and placement of a Filterwire in the left vertebral artery. The proximal left subclavian artery was successfully stented without complications. Debris was retrieved in the Filterwire.

Optical coherence tomography findings after chronic total occlusion interventions: Insights from the "AngiographiC evaluation of the everolimus-eluting stent in chronic Total occlusions" (ACE-CTO) study (NCT01012869).

BACKGROUND: There is limited information on optical coherence tomography (OCT) findings after percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). OCT allows high resolution imaging that can enhance understanding of the vascular response after stenting of chronically occluded vessels. METHODS: The Angiographic Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions (ACE-CTO) study collected angiographic and clinical outcomes from 100 patients undergoing CTO PCI with the everolimus-eluting stent (EES). OCT was performed 8-months post stenting in 62 patients. Every third frame was analyzed throughout the course of the stented arterial segment. Lumen contours were semi-automatically traced and stent struts were manually delineated, with automatic measurement of the strut to lumen distance. Struts on the luminal side of the lumen contour were classified as malapposed if the distance to the lumen contour exceeded 0.108mm. RESULTS: A total of 44,450 struts in 6047 frames were analyzed, of which 4113 9.3%, 95% confidence intervals [CI] 9.0% to 9.5%) were malapposed and 1230 (2.8%, 95% CI 2.6% to 2.9%) were uncovered. Fifty-five of 62 patients (88.7%, 95% CI 78.5% to 98.4%) had at least one malapposed stent strut and 50 patients (80.7%, 95% CI 69.2% to 88.6%) had at least one uncovered stent strut. Mean strut-intimal thickness of the apposed and malapposed struts was 0.126±0.140mm and -0.491±0.440mm, respectively. CONCLUSION: High rates of stent strut malapposition and incomplete stent strut coverage were observed after CTO PCI using EES, highlighting unique challenges associated with stent implantation in CTOs.

The AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusion (ACE-CTO) Study.

BACKGROUND: There are limited data on outcomes after implantation of second-generation drug-eluting stents in coronary chronic total occlusions (CTOs). We aimed to evaluate the frequency of angiographic restenosis and clinical outcomes after implantation of the everolimus-eluting stent (EES) in coronary CTOs. METHODS: One hundred patients undergoing successful CTO percutaneous coronary intervention using EES at our institution between 2009 and 2012 were enrolled. The primary study endpoint was binary in-segment restenosis at 8-month follow-up quantitative coronary angiography. Secondary endpoints included death, myocardial infarction, target-lesion and target-vessel revascularization, and symptom improvement. RESULTS: Mean age was 64 ± 7 years and 99% of the patients were men. The successful crossing technique was antegrade wiring in 51 patients, antegrade dissection/reentry in 24 patients, and retrograde in 25 patients. Binary angiographic restenosis occurred in 46% of the patients (95% confidence interval [CI], 35%-57%). The pattern of restenosis was focal, proliferative, and total occlusion in 19 lesions (46%), 14 lesions (34%), and 8 lesions (20%), respectively. At 12 months, the incidences of death, myocardial infarction, target-lesion revascularization, and target-vessel revascularization were 2%, 2%, 37%, and 39%, respectively. At 12 months, symptoms were improved, unchanged, or worse compared with baseline in 89 patients, 8 patients, and 1 patient, respectively (2 patients died before the 12-month follow-up). On multivariable analysis, smaller stent diameter was associated with higher risk for binary angiographic restenosis. CONCLUSION: High rates of angiographic restenosis and repeat revascularization were observed among patients receiving EES in coronary CTOs, but most had significant symptom improvement.

Prevalence and treatment of "balloon-uncrossable" coronary chronic total occlusions.

BACKGROUND: The frequency and outcomes of "balloon-uncrossable" coronary chronic total occlusions (CTOs) have received limited study. METHODS: We retrospectively examined 373 consecutive CTO percutaneous coronary interventions (PCIs) performed at our institution between 2005 and 2013 to determine the frequency and treatment of balloon-uncrossable CTOs. RESULTS: Mean age was 63.7 ± 8.3 years and 98.9% of the patients were men. Twenty-four patients (6.4%, 95% confidence intervals 4.2% to 9.4%) were found to have a balloon-uncrossable CTO. Compared to the other CTO PCI patients, those with balloon-uncrossable CTOs had similar clinical and angiographic characteristics. Successful crossing of the balloon-uncrossable CTO was achieved in 22 of 24 patients (91.7%) using a variety of techniques, such as successive balloon inflations (43.5%), microcatheter advancement (21.7%), laser (8.7%), techniques that increase guide catheter support (13.0%), and subintimal lesion crossing (13.0%). Patients with balloon-uncrossable CTOs had longer procedure time (184.5 ± 77.9 vs 134.0 ± 69.0 min, P<.01), fluoroscopy time (55.2 ± 24.9 vs 37.9 ± 20.8 min, P<.01), and received high contrast volume (404.4 ± 137.9 vs 351.7 ± 138.5 mL, P=.08), but had similar incidence of major complications (8.3% vs 3.2%, P=.25) as compared with patients who did not have balloon-uncrossable CTOs. CONCLUSION: Balloon-uncrossable CTOs are encountered in 6.4% of contemporary CTO PCIs and can be successfully treated in most patients using a variety of techniques.

Periprocedural myocardial injury in chronic total occlusion percutaneous interventions: a systematic cardiac biomarker evaluation study.

OBJECTIVES: This study sought to evaluate the incidence, correlates, and clinical implications of periprocedural myocardial injury (PMI) during percutaneous coronary intervention (PCI) of chronic total occlusions (CTO). BACKGROUND: The risk of PMI during CTO PCI may be underestimated because systematic cardiac biomarker measurement was not performed in published studies. METHODS: We retrospectively examined PMI among 325 consecutive CTO PCI performed at our institution between 2005 and 2012. Creatine kinase-myocardial band fraction and troponin were measured before PCI and 8 to 12 h and 18 to 24 h after PCI in all patients. PMI was defined as creatine kinase-myocardial band increase ≥ 3 x the upper limit of normal. Major adverse cardiac events during mid-term follow-up were evaluated. RESULTS: Mean age was 64 ± 8 years. The retrograde approach was used in 26.8% of all procedures. The technical and procedural success was 77.8% and 76.6%, respectively. PMI occurred in 28 patients (8.6%, 95% confidence intervals: 5.8% to 12.2%), with symptomatic ischemia in 7 of those patients. The incidence of PMI was higher in patients treated with the retrograde than the antegrade approach (13.8% vs. 6.7%, p = 0.04). During a median follow-up of 2.3 years, compared with patients without PMI, those with PMI had a higher incidence of major adverse cardiac events (hazard ratio [HR]: 2.25, p = 0.006). Patients with only asymptomatic PMI also had a higher incidence of major adverse cardiac events on follow-up (HR: 2.26, p = 0.013). CONCLUSIONS: Systematic measurement of cardiac biomarkers post-CTO PCI demonstrates that PMI occurs in 8.6% of patients, is more common with the retrograde approach, and is associated with worse subsequent clinical outcomes during mid-term follow-up.

Clinical, angiographic, and procedural predictors of periprocedural complications during chronic total occlusion percutaneous coronary intervention.

OBJECTIVES: To identify clinical, angiographic, and procedural factors associated with increased risk of periprocedural complications during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Successful CTO PCI can provide significant clinical benefit; however, procedural risks have received limited study. We sought to identify factors associated with increased CTO PCI periprocedural risk that could be utilized to guide patient and lesion selection. METHODS: The clinical, angiographic, and procedural records of 336 consecutive CTO PCI procedures performed at a single center from May 2005 through 2012 were reviewed, and data on periprocedural complications were recorded. Logistic regression was performed to identify independent predictors of periprocedural complications during CTO PCI. RESULTS: The incidence of major and minor complications was 3.9% and 10.4%, respectively. Minor bleeding and vascular events were the most common complications (4.8%), followed by perforation (2.4%), contrast-induced nephropathy (1.8%), and transient hypotension (0.6%). Major complications were uncommon: death (0.3%); emergency coronary artery bypass grafting (0.6%); stroke (0.3%); tamponade (0.3%); clinical myocardial infarction (0.9%); donor vessel injury (0.6%); and major bleeding or vascular events (0.9%). Patients who experienced any complication had higher preprocedure troponin levels and were more likely to undergo treatment using the retrograde approach. In multivariable analysis, use of the retrograde approach was independently associated with increased risk of periprocedural complications (odds ratio, 2.057; 95% confidence interval, 1.045-4.051; P=.04). CONCLUSIONS: Major complications of CTO PCI are infrequent, but are more common with use of the retrograde approach.

Randomized controlled trial on the impact of music therapy during cardiac catheterization on reactive hyperemia index and patient satisfaction: the Functional Change in Endothelium After Cardiac Catheterization, With and Without Music Therapy (FEAT) study.

OBJECTIVES: To determine the impact of music intervention on endothelial function, hemodynamics, and patient anxiety before, during, and after cardiac catheterization. BACKGROUND: The effect of music therapy during cardiac catheterization on endothelial function and patient satisfaction has received limited study. METHODS: Seventy patients undergoing elective cardiac catheterization were randomized to music therapy (n=36) or no music therapy (n=34). Peripheral arterial tonometry was performed before and after catheterization. A 6 item (24-point scale) questionnaire evaluating patient anxiety and discomfort levels was also administered after the procedure. RESULTS: Both study groups had similar baseline characteristics, fluoroscopy time, and contrast administration. Reactive hyperemia index (RHI) change was 0.14 ± 0.72 in the music group and 0.30 ± 0.58 in the control group (P=.35). Systolic and diastolic blood pressure (BP) changes did not significantly differ between the two groups (systolic BP change -3.3 ± 17.3 mm Hg vs -2.3 ± 19.4 mm Hg; P=.83 and diastolic BP change -1.9 ± 12.2 mm Hg vs. 2.0 ± 13.4 mm Hg; P=.23). Heart rate changes were also comparable between the two groups (-1 ± 6 beats/ min vs -1 ± 7 beats/min; P=.22). Patient satisfaction questionnaire measurements were found to be similar in patients with and without music therapy (8 [7-11] vs 9 [8-12]; P=.36). CONCLUSIONS: In this study, music intervention did not elicit a vasodilator response, did not lower blood pressure or heart rate, and did not relieve anxiety or stress discomfort in patients who underwent coronary angiography.

Angiographic success and procedural complications in patients undergoing retrograde percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 3,482 patients from 26 studies.

BACKGROUND: The efficacy and safety profile of retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We sought to perform a weighted meta-analysis of the success and complication rates of retrograde CTO PCI. METHODS: We conducted a meta-analysis of 26 studies published between 2006 and April 2013 reporting in-hospital outcomes of retrograde CTO PCI. Data on procedural success, frequency of death, emergent coronary artery bypass graft surgery (CABG), stroke, myocardial infarction (MI), perforation, tamponade, stent thrombosis, major vascular or bleeding events, contrast nephropathy, and radiation skin injury were collected. RESULTS: A total of 26 studies with 3482 patients and 3493 target CTO lesions were included. Primary retrograde CTO PCI was attempted in 52.4%. Pooled estimates of outcomes were as follows: procedural success 83.3% [95% confidence interval (CI): 79.0% to 87.7%]; death 0.7% (95% CI: 0.5% to 1.2%); urgent CABG 0.7% (95% CI: 0.4% to 1.2%); tamponade 1.4% (95% CI: 1.0% to 2.2%); collateral perforation 6.9% (95% CI: 4.6% to 10.4%); coronary perforation 4.3% (95% CI: 1.2% to 15.4%); donor vessel dissection 2% (95% CI: 0.9% to 4.5%); stroke 0.5% (95% CI: 0.2% to 1.0%); MI 3.1% (95% CI: 0.2% to 5.0%); Q wave MI 0.6% (95% CI: 0.4% to 1.1%); vascular access complications 2% (95% CI: 0.9% to 4.5%); contrast nephropathy 1.8% (95% CI: 0.8% to 3.7%); and wire fracture and equipment entrapment 1.2% (95% CI: 0.6% to 2.5%). CONCLUSIONS: Retrograde CTO PCI is associated with high procedural success rate and acceptable risk for procedural complications.