Ten-year outcome of intraoperative treatment of atrial fibrillation using radiofrequency ablation.

BACKGROUND: Intraoperative radiofrequency ablation (RFA) has been advocated to treat atrial fibrillation (AF). This report examines the long-term effects of intraoperative RFA in the prevention of recurrence of AF when used as an adjunctive treatment in patients undergoing cardiac procedures for primary indications unrelated to their arrhythmia. METHODS: The study reviewed the records of patients from a tertiary medical center which had 2 cardiac surgeons performing an intraoperative adjunctive RFA procedure. A total of 20 patients undergoing RFA between April 11, 2003 and May 10, 2005 were included and followed for up to 10 years. The primary effectiveness outcome of the study was the recurrence of AF during the follow-up period. Data were collected from office or hospital medical records. RESULTS: A total of 20 patients were included (mean age 69.4 years, males 40%). Eight patients were followed for 10 years and 2 patients for 9 years; 7 patients died during the 10-year follow-up period and 3 patients were lost to follow-up. As their primary procedures, the patients underwent valve surgery (65%), bypass surgery (15%), or both (20%). Intraoperative RFA failed to restore sinus rhythm in 2 patients. In the remaining 18 patients, AF recurred in 10 patients within 2 months of surgery, in 1 patient at 5 months, in 1 patient at 7 months, and in 6 patients after 1 year. CONCLUSION: AF had recurred in 100% of patients by the end of the long-term follow-up period. The adjunctive intraoperative RFA and postoperative interventions employed in this early study failed to maintain sinus rhythm.

Safety and Effectiveness of Closure Devices Applied to a Stented Common Femoral Artery: A Retrospective Analysis.

Bailout stenting of the common femoral artery (CFA) may become necessary with failed balloon angioplasty or atherectomy or in case of bleeding requiring a covered stent over the arteriotomy site. Reaccessing the CFA through a previously placed stent may occur during angiography. The safety and effectiveness of applying a closure device, or manual compression to achieve hemostasis through an accessed stented CFA are unknown. All patients in our practice that underwent CFA stenting were identified using billing records for 3 years (January 1, 2010-February 28, 2013). Patients were included if there has been documentation of access through the stented CFA segment on angiography. In-hospital and up to 2 weeks postdischarge major adverse events were recorded from medical records. A total of 48 patients were included in the study. The mean age was 65.9 ± 10.9 years, males 60.4%. Perclose (Abbott Vascular, Santa Clara, CA) was used in 85.7%, AngioSeal (St. Jude Medical, St. Paul, MN) in 8.3%, Mynx (Access Closure, Santa Clara, CA) in 2%, and manual compression in 4% of the patients. Major adverse events consisted of in-hospital mortality in two patients: one probably related to index access-site thrombosis complicated by subsequent acute renal failure following reintervention; the other mortality was related to major bleeding possibly related to the index access site. The remaining patients had no adverse events and there were no reported problems at 2 weeks follow-up. Accessing and applying closure device in stented CFA can be accomplished successfully in approximately 96% of the patients with low major adverse events.

JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study.

PURPOSE: To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment. METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9 ± 11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). Lesion length was 17.4 ± 13.1 cm. The primary effectiveness outcome was acute success (≤ 30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory. RESULTS: Treated length was 19.5 ± 12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6 ± 3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months. CONCLUSION: JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results.

The learning curve in treating coronary chronic total occlusion early in the experience of an operator at a tertiary medical center: The role of the hybrid approach.

BACKGROUND: Treatment of chronic total occlusion (CTO) is complex and has a low adoption rate by interventional cardiologists. The introduction of the hybrid approach has provided a systematic step-by-step approach to treat complex CTO lesions with a high success rate. We describe the overall experience with the use of the hybrid approach of a non-CTO operator and analyze differences in the procedural and long term outcomes before and after the initial 30 cases performed. METHODS: A total of 67 unselected, consecutive patients (68 lesions) underwent PCI of a CTO between January 2012 and June 2013 by a non-CTO operator. Patients were followed up for 1year using office and hospital medical records and death certificates. Cases were divided into the first consecutive 30 patients and compared to the subsequent 37 patients. The primary endpoint was acute procedural success defined as residual narrowing of ≤30% with no major adverse events. Secondary endpoints included the independent outcomes of death, major bleeding, perforations with cardiac tamponade, acute stent thrombosis (ST), target lesion revascularization (TLR) and target vessel revascularization (TVR). Descriptive analysis was performed on all variables. Univariate analysis was used to compare both groups. RESULTS: Baseline characteristics were as follows: mean age 63.9±10.6years, males 80.6%, diabetes 41.8%, de novo lesions 100%, ejection fraction 49.9±13.8%, CTO length 76.9±45.7mm, number of drug eluting stents per CTO 2.8±1.6 (median 3), contrast use 397±161.3ml, fluoroscopy time 51±32min and procedure time 134.3±74.7min. Lesions were crossed using an antegrade approach in 70.6% and a combined retrograde/antegrade approach in 29.4%. Crossing was intraluminal in 83.8% and subintimal in 16.2%. Acute procedural success was 95.5%. MAE included pericardial effusion with tamponade in 4.5%. On follow-up, TLR occurred in 6.6% of patients and TVR in 13.1%. There were no definite ST, one (1.6%) probable ST and one (1.6%) possible ST. Cardiac death occurred in 4.8% and non-cardiac death 1.6%. When comparing early experience (first 30 cases) with subsequent one, there were no differences in CTO length (60±47.6mm vs 83.2±43.7mm, p=0.206) or coronary distribution of the CTO. The number of drug eluting stents used per CTO (2.6±1.7 vs 3.0±1.5, p=0.289), contrast use (401±141.2ml vs 393.7±177.8ml, p=0.856), fluoroscopy time (48.9±25.6min vs 52.9±36.5min, p=0.617), or procedure time (116.8±48.6min vs 148.5±88.7min, p=0.068) were statistically similar between the 2 groups. Less crossing catheters were used (1.1±1 vs 0.6±0.7, p=0.024) and more lesions were crossed via antegrade approach after the initial experience (antegrade crossing: 53.3% vs 84.2% respectively, p=0.008). There was numerically more procedural success after the initial experience (90 vs 100%, p=0.085). MAE, TLR and TVR were similar on 1year follow-up. CONCLUSION: A high success rate was seen using the hybrid approach to treat CTO by a non-CTO operator. Although less crossing catheters were used and more lesions were treated via the antegrade approach after the initial experience, procedural and long term outcomes were otherwise similar between the early versus the late experience.

Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: randomized, double-blind crossover pilot study.

BACKGROUND: Patients with ischemic cardiomyopathy (ICM) may continue to experience persistent chest pain and/or dyspnea despite pharmacologic therapy and revascularization. We hypothesized that ranolazine would reduce anginal symptoms or dyspnea in optimally treated ICM patients. METHODS: In this randomized, double-blind, crossover-design pilot study, 28 patients with ICM (ejection fraction less or equal 40%) were included after providing informed consent. A total of 24 patients completed both placebo and ranolazine treatments and were analyzed. All patients were on treatment with a beta blocker, an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker), and at least one additional antianginal drug. After randomization, patients received up to 1,000 mg ranolazine orally twice a day, as tolerated, versus placebo. The primary end point was change in angina as assessed by the Seattle Angina Questionnaire (SAQ), or in dyspnea as assessed by the Rose Dyspnea Scale (RDS). Change in the RDS and SAQ score from baseline was compared, for ranolazine and placebo, using the Wilcoxon signed rank test or paired t-test. RESULTS: Patients had the following demographic and clinical variables: mean age of 71.5 years; male (82.1%); prior coronary bypass surgery (67.9%); prior coronary percutaneous intervention (85.7%); prior myocardial infarction (82.1%); diabetes (67.9%); and mean ejection fraction of 33.1%. No statistical difference was seen between baseline RDS score and that after placebo or ranolazine (n=20) (P≥0.05). There was however, an improvement in anginal frequency (8/10 patients) (P=0.058), quality of life (8/10 patients) (P=0.048), and mean score of all components of the SAQ questionnaire (n=10) (P=0.047) with ranolazine compared with placebo. CONCLUSION: In optimally treated ICM patients with continued chest pain or dyspnea, ranolazine possibly had a positive impact on quality of life, a reduction in anginal frequency, and an overall improvement in the mean SAQ component score compared with baseline. Ranolazine did not change the dyspnea score compared with baseline.

Sex differences in long-term outcomes of coronary patients treated with drug-eluting stents at a tertiary medical center.

BACKGROUND: Limited data exist on contemporary sex-related differences in long-term outcomes of coronary patients receiving drug-eluting stents. In this study we evaluate differences for males (M) and females (F) in 2-year target lesion failure (TLF) in an unselected consecutive series of patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) at a tertiary medical center. METHODS: Data on 348 consecutive patients (M 221, F 127) stented with EES and PES were retrospectively analyzed. The primary end point of the study was to compare sex-related outcomes in TLF, defined as the combined end point of cardiac death, nonfatal myocardial infarction, and target lesion revascularization (TLR). Secondary end points included TLR, target vessel failure, target vessel revascularization, acute stent thrombosis as defined by the Academic Research Consortium, and cardiac death. The cineangiograms of the first consecutive 162 patients (M 105, F 57) were independently reviewed by a cardiologist blinded to clinical outcome, and SYNTAX scoring was performed. Follow-up was achieved using medical records and/or phone calls and was censored at 2 years. Descriptive analysis was performed on all variables. Univariate analysis compared the M and F cohorts. Multivariate analysis using Cox regression was performed to determine independent predictors of TLF with time, including sex as an independent variable in the model. RESULTS: M had more prior percutaneous coronary interventions and restenotic lesions and a higher prevalence of smoking. They also had longer length of disease and received more stents than F. F were older and had a higher prevalence of prior stroke. Angiographic complexity was not statistically different between the two groups, as judged by SYNTAX scoring (M 20.8±13.8, F 19.7±13.9, P=0.650). At 2-year follow-up, TLF was 27.4% and 24.8% (P=0.614) with no statistical difference between TLR (23.3% versus [vs] 21.6%), cardiac death (2.8% vs 3.2%), and definite and probable stent thrombosis (2.3% vs 0.0%) in M and F, respectively. Cox regression analysis using backward elimination showed that the number of stents per patient was the only independent predictor of TLF with time (hazard ratio 1.201, 95% confidence interval 1.126-1.280, P=0.001). CONCLUSION: In this cohort of patients receiving EES and PES, M and F did not have statistically different outcomes at 2-year follow-up, consistent with recent reports in the current era of percutaneous coronary interventions.

Differences in patient selection and outcomes between SilverHawk atherectomy and laser ablation in the treatment of femoropopliteal in-stent restenosis: a retrospective analysis from a single center.

PURPOSE: To analyze differences in the application and outcomes of SilverHawk atherectomy (SH) and excimer laser ablation (ELA) in the treatment of femoropopliteal in-stent restenosis (ISR) in an unselected cohort of patients treated at a single center. METHODS: Between January 2005 and June 2010, 81 consecutive patients (46 men; mean age 69.1 years, range 43-86) underwent directional atherectomy (41 SH, 40 ELA) for femoropopliteal ISR lesions. Data were reviewed retrospectively on procedural outcomes, major adverse events, and 1-year target lesion revascularization (TLR) obtained from medical records and supplemented with telephone calls. The primary endpoint was symptom-driven TLR at 1 year; secondary endpoints were death and amputation. RESULTS: ELA was utilized more frequently than SH in longer lesions (210.4±104 vs. 126.2±79.3 mm, respectively; p=0.001), subacute presentation (55% vs. 14.6%, p=0.001), TASC D lesions (47.5% vs. 12.2%), and in patients with more angiographic thrombus (42.5% vs. 4.9%, p=0.001). Final angiographic success (<30% residual narrowing post final treatment) was similar between ELA and SH (92.5% vs. 100%, respectively, p=0.12). Bailout stenting was significantly higher with ELA vs. SH (50.0% vs. 24.4%, p=0.022). At 1 year, TLR had occurred in 48.7% of the ELA patients vs. 31.7% of the SH cases (p=0.171). Regression analysis confirmed that SH was a predictor of TLR at 1 year (hazard ratio 2.679, 95% CI 1.015 to 7.073, p=0.047). CONCLUSION: Both SH and ELA continue to have a high TLR rate in treating ISR of the femoral and popliteal arteries. A higher rate of delayed failure is seen with SH and an earlier, steeper loss of TLR-free survival is seen with ELA.

Age differences in long term outcomes of coronary patients treated with drug eluting stents at a tertiary medical center.

We evaluate differences in outcomes in younger (<65 years) and older (≥65 years) patients for target lesion failure (TLF) at 2-year follow-up in an unselected consecutive series of patients treated with the everolimus- (EES) and paclitaxel-eluting (PES) stents at a tertiary medical center. 348 consecutive patients (younger 150; older 198) stented with the EES and PES were retrospectively analyzed. The primary endpoint was TLF (composite endpoint of cardiac death, non fatal myocardial infarction due to index vessel and target lesion revascularization (TLR)). At 2 years follow up, younger versus older patients had the following outcomes respectively: TLF 27.7% versus 25.5% (P = 0.71), TLR 24.8% versus 21.4% (P = 0.52), cardiac death 3.4% versus 2.5% (P = 0.75) and definite and probable stent thrombosis (2.0% versus 1.0%). Multivariate analysis showed that renal failure (odds ratio: 2.55, P = 0.045), number of stents per patient (odds ratio: 1.60, P = 0.001) and younger age (odds ratio: 0.97; P = 0.010), but not gender, diabetes or type of DES stent (EES versus PES) predicted TLF. We conclude that older age was not a predictor of TLF at 2-year follow-up after adjusting for renal insufficiency, number of stents used per patient, gender, diabetes and type of DES used.

Outcomes of Patients Treated with the Everolimus- versus the Paclitaxel-Eluting Stents in a Consecutive Cohort of Patients at a Tertiary Medical Center.

In this study, we compare the outcomes of the paclitaxel-eluting stent (PES) versus the everolimus-eluting stent (EES) treated patients at a tertiary medical center and up to 2 years follow-up. Unselected consecutive patients were retrospectively recruited following stenting with PES (159 patients) or EES (189 patients). The primary endpoint of the study was target lesion failure (TLF), defined as the combined endpoint of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR). Secondary endpoints included target vessel revascularization (TVR), TLR, target vessel failure (TVF), acute stent thrombosis (ST), total death, cardiac death, and nonfatal MI. Patients treated with the PES stent had less congestive heart failure and restenotic lesions, but a higher prevalence of longer lesions, nonleft main bifurcations, required more stents per patient (4.3 ± 2.8 vs. 2.9 ± 2.1). TLF occurred in 32.3% PES versus 21.5% EES (p = 0.027). The secondary unadjusted endpoints for PES versus EES, respectively, were TVF 38.6 versus 30.7% (p = 0.140), TVR 35.7 versus 26.5% (p = 0.079), definite and probable ST 1.2 versus 0.0%, nonfatal MI 4.5 versus 4.2%, and mortality 9.6 versus 4.0%. Logistic regression analysis showed that the numbers of stents per patient (p = 0.001), age (p = 0.01), and renal failure (p = 0.045) were independent predictors of TLF. Using univariate analysis, EES had lower TLF than PES in a cohort of unselected patients undergoing percutaneous coronary intervention at 2 years follow-up. Multivariate analysis showed that the numbers of stents per patient, age, and renal failure, but not stent type, were predictors of TLF.

Treatment of subacute and chronic thrombotic occlusions of lower extremity peripheral arteries with the excimer laser: a feasibility study.

BACKGROUND: Thrombus is highly prevalent in patients with recent symptoms (< 6 months) of claudication or limb ischemia due to an occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the excimer laser (Spectranetics, Colorado Springs, CO) has been tested for its safety and ability to ablate thrombus in patients with recent arterial occlusions. METHODS: Angiographic operator assessment and volumetric core lab quantitation of the thrombus were performed at baseline and after excimer laser but prior to definitive treatment of the vessel to evaluate thrombus resolution. Consecutive patients were prospectively enrolled at a single site. Procedural success was defined as achieving a residual stenosis of <30% after final treatment with no intraprocedural complications requiring additional treatment. RESULTS: 20 consecutive patients were enrolled in this study (8 males, mean age 69.5±11.1 years). Based on patients symptom onset, 12 patients were subacute (> 24 h, < 30 days), and 8 chronic (between 1 to 6 months). 15/20 (75%) had restenotic occlusions. Due to the long, occlusive nature of these lesions, only 8 patients had complete intravascular ultrasound images at each time point which allowed volumetric analysis by the core lab. There was no statistical difference in plaque/thrombus volume between baseline (pretreatment) and excimer laser (P=.68). There was however a significant reduction in residual angiographic stenosis post laser alone (100% vs. 66.75%±23.9%, P=.001). Procedural success was 100%. There were no deaths or amputations. Bail out stenting was performed in 10/20 (50%) patients. Embolic filters were used in 15/20 (75%) of patients. Macrodebris>2 mm were seen in 85.7% of filters. There was no in-hospital or 30-day reocclusion of the treated vessel but one patient had a vascular access complication (small AV fistula) conservatively managed. No other serious adverse events were noted. CONCLUSION: Using the excimer laser appears safe in this small feasibility study of subacute and chronic thrombotic occlusions. Angiographically, there was a significant reduction in percent stenosis with the laser alone. The limited IVUS data did not show a reduction in plaque/thrombus volume but the number of interpretable ultrasounds was small. Further data are needed to address the effectiveness of the laser in treating these thrombotic occlusions and its advantages over balloon angioplasty.

Percutaneous lower extremity arterial interventions using primary balloon angioplasty versus cryoplasty: a randomized pilot trial.

BACKGROUND: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus cryoplasty (CRYO) in the treatment of de novo femoropopliteal disease has not been well defined in randomized trials. METHODS: In this prospective, 2-center randomized trial of PTA vs CRYO of femoropopliteal arteries, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bail out stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major adverse events including death and amputations were recorded. A two sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross tabular analysis was conducted with nonparametric tests (Chi Square and Fisher's Exact) used to test for significant differences. RESULTS: A total of 40 patients were included in the study. Of these 20 patients (24 vessels) were included in the PTA arm and 20 patients (26 vessels) in the CRYO arm. CRYO was performed at a predefined automated pressure of 8 atm. PTA was performed at a mean pressure of 9.57±1.34 atm (P=.001 compared to CRYO). TLR (10.5% vs. 15%, P=NS) and TVR (10% vs 25%, P=NS) were statistically similar between the PTA arm compared to the CRYO arm respectively. Bail out stenting was performed in 10/24 (41.7%) of vessels in the PTA arm and 10/26 (38.5%) of patients in the CRYO arm (P=NS). CONCLUSION: In this pilot randomized study of de novo femoropopliteal lesions, CRYO and PTA had the same TLR and TVR at 6 months in treating femoropopliteal de novo lesions. Also, bail out stenting was statistically similar between the 2 groups. Larger studies are needed to confirm these results.

Safety and 1-year revascularization outcome of SilverHawk atherectomy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center.

BACKGROUND: Treatment of in-stent restenosis of the femoropopliteal arteries with balloon angioplasty carries a high rate of recurrence and requires frequent repeat stenting. In the "Instructions for Use," SilverHawk atherectomy (SA) is contraindicated for in-stent restenosis at a peripheral site. SA, however, has a theoretical advantage of reducing the volume of restenotic tissue and potentially delaying the need for frequent repeat revascularization and additional stenting. We present a retrospective analysis from our center on the safety and outcomes of SA in the treatment of in-stent restenosis of the femoropopliteal arteries. METHODS: Demographic, clinical, angiographic, and procedural data were collected on all patients who underwent SA for in-stent restenosis from February 2005 to April 2010 at a single medical center. Major adverse events and 1-year target lesion revascularization (TLR) and target vessel revascularization (TVR) were obtained by review of medical records and phone calls. Descriptive analysis was performed on all variables. Kaplan-Meier survival curves for TVR were plotted. RESULTS: A total of 41 consecutive patients (mean age 70.9±9.2 years, 56% males) were included and followed for a mean of 331.63 days. The following variables were noted: mean ankle brachial index (ABI) of treated leg 0.66±0.2; chronic renal failure (creatinine >2.0 at baseline) 14.6%; diabetes 61%; history of smoking 85.4%; number of vessel runoffs of treated limb 1.9±0.9; hypertension 90.2%; lesion length 126.2±79.3mm; lesion severity 90.7±8.2%; vessel diameter 5.8±0.7 mm. All patients received bivalirudin during the procedure and were on aspirin. Ninety-five percent of patients were placed on clopidogrel. Adjunctive balloon angioplasty was performed in 97.6% at a mean pressure of 11.9±3.3atm. Embolic filter protection (EFP) was used in 56.1% of patients. Bailout stenting was 24.4%. Acute procedural success (<30% angiographic residual narrowing) occurred in 100% of patients. Compared to baseline, ABI at 1 month significantly improved to 0.91±0.19 (P<0.05) but was not statistically different at 1 year (0.61±0.28). Debris was noted in 81.9% of filters used; 36.4% were macrodebris. The following adverse events were reported: distal embolization (DE) requiring treatment 7.3%; stent thrombosis 4.9%; planned minor amputation in the nonindex limb 2.4%. No device-related complications occurred. There was no death or amputation. TLR and TVR occurred in 31.7% and 34.1%, respectively. CONCLUSION: SA has favorable acute results in treating in-stent restenosis of the femoropopliteal arteries. At 1 year, TLR and TVR remain high but compare favorably to published data. DE also occurs significantly with SA and EFP appears to be effective in capturing the debris.

Outcomes of patients treated with the everolimus-eluting stent versus the zotarolimus eluting stent in a consecutive cohort of patients at a tertiary medical center.

BACKGROUND: In this study we compared the outcomes of the everolimus-eluting stent (EES) versus the zotarolimus-eluting stent (ZES) in patients treated at a tertiary medical center, with up to one year of follow-up. METHODS: Unselected consecutive patients were retrospectively recruited following stenting with the ZES (n = 197) or EES (n = 190). The first 100 consecutive patients in each cohort underwent syntax scoring. The primary endpoint of the study was target vessel failure, defined as the combined endpoint of cardiac death, non-fatal myocardial infarction, or target vessel revascularization. Secondary endpoints included target lesion revascularization, target lesion failure, acute stent thrombosis, total death, cardiac death, and non-fatal myocardial infarction. RESULTS: The two groups were similar, including for Syntax scores (19.6 ± 12.8 versus 20.6 ± 13.6), number of stents per patient (2.9 ± 1.9 versus 2.9 ± 2.1), and cardiovascular risk factors. By one year, the primary outcome occurred in 20.8% EES versus 26.7% ZES (P = 0.19) patients. The secondary endpoints were as follows: target lesion revascularization (8.9% versus 20.6%, P = 0.003), target vessel revascularization (18.9% versus 25.6%, P = 0.142), definite and probable stent thrombosis (0% versus 2.5%), non-fatal myocardial infarction (2.7% versus 3.6%), and mortality (3.2% versus 5.1%) for the EES versus the ZES, respectively. CONCLUSION: EES had similar target vessel failure to ZES, but superior target lesion revascularization and target lesion failure at one year of follow-up in an unselected cohort of patients.

What is an appropriate reference standard in the quantitation of plaque surface area by intravascular coronary ultrasound?

We reevaluate the predictive accuracy of intravascular ultrasound (IVUS)-derived per cent plaque area stenosis (PAS) in significant coronary lesions (CLs) with or without proximal and distal reference vessel area adjustment. IVUS is valuable in defining moderate CL severity (30 to 70%) in left main (LM) or non-left main (NLM) coronaries using minimum luminal area (MLA) of ≤5.9 and ≤4 mm(2), respectively. Despite a strong correlation with severe CLs, PAS (≥ 70% for NLM and ≥67% for LM) remains underutilized because of confusion about an appropriate reference standard. We studied 120 patients with symptomatic moderate CLs (74 NLM, 46 LM) who underwent IVUS. In-lesion and adjusted PAS were derived by subtracting MLA from in-lesion and proximal or distal reference's external elastic membrane (EEM) area, respectively, divided by corresponding EEM area multiplied by 100. In-lesion PAS was correlated with MLA cutoffs of ≤5.9 and ≤7.5 mm(2) for LM and ≤4 mm(2) for NLM. Adjusted PAS strongly correlated with in-lesion PAS irrespective of reference segment (proximal reference, r = 0.879, p < 0.001; distal reference, r = 0.833, p < 0.001; mean proximal and distal reference, r = 0.896, p < 0.001). Considering MLA of ≤4 mm(2) (for NLM) and ≤5.9 mm(2) (for LM), in-lesion PAS of ≥70 and ≥67%, respectively, explained the majority of severe CLs but the sensitive LM MLA cutoff of ≤7.5 mm(2) showed higher predictive accuracy. Based on results, both in-lesion PAS and adjusted PAS can be used interchangeably and correlate strongly with MLA.

Dethrombosis of lower extremity thrombus by local delivery of thrombolysis using ClearWay transcatheter balloon irrigation: a feasibility study.

BACKGROUND: Thrombus is highly prevalent in patients with recent symptoms (<6 months) of claudication or limb ischemia with occluded culprit lower extremity arterial vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the Vascular ClearWay Irrigating PTFE Balloon Catheter (Atrium, Husdson, NH, USA) has been tested for its safety and ability to dissolve thrombus in patients with recent arterial occlusions. METHODS: Twenty consecutive patients with lower extremity occlusion were prospectively enrolled to test the feasibility of the ClearWay balloon irrigation system. Cohorts of five patients were tested with increasing doses of tPA (five control patients with saline, five patients with 0.25 mg/cm, five patients with 0.4 mg/cm and five patients with 0.6 mg/cm of lesion length). Volumetric intravascular ultrasound core laboratory assessment of the thrombus was performed at baseline and after ClearWay thrombolysis (but prior to definitive treatment of the vessel with other debulking or stenting) to evaluate the effectiveness of ClearWay to remove thrombus. RESULTS: Twenty consecutive patients were enrolled in this study (11 men; mean age, 68.54 ± 8.15 years), and 14 had volumetric intravascular ultrasound available both before and after Clearway. Based on patients' symptom onset, 1 patient was acute (< 24 h), 4 subacute (> 24 h, < 30 days) and 15 chronic (between 1 and 6 months). There were no safety events as predefined by the protocol including no major bleeding, death, distal embolization distal to the filter, acute renal failure or vascular complications. Acute procedural success was seen in 100% of cases. There were no statistical difference in plaque-thrombus volume between baseline (pretreatment) and control ClearWay treatment (saline infusion; P = .911, n = 4). Also, there was no statistical difference in plaque-thrombus volume between pretreatment baseline and ClearWay tPA treatment (P = .628, n = 14). Following Angiojet rheolytic thrombectomy (n = 8 patients) post-ClearWay lytic treatment, there was a statistical reduction of plaque-thrombus volume versus ClearWay lytic treatment alone (P = .030) or pretreatment baseline (P = .029). There were no deaths or amputations. Macrodebris > 2 mm were present in 50% of patients captured by embolic filter protection. In-hospital reocclusion of the treated vessel occurred in one patient (5%) and 30-day reocclusion occurred in two patients (10%) on follow-up. CONCLUSION: Using the ClearWay to deliver lytic therapy appears safe in this small feasibility study. Although lytic treatment with the ClearWay balloon alone did not demonstrate reduction in plaque-thrombus volume in this small population, the use of Angiojet rheolytic thrombectomy following ClearWay did reduce plaque volume. Further data are needed to address definitive effects of ClearWay balloon alone and utility to facilitate Angiojet thromboreduction.

Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial.

PURPOSE: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches. MATERIALS AND METHODS: In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR). RESULTS: Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001). CONCLUSIONS: TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA.

Predictors of provisional stenting in patients undergoing lower extremity arterial interventions.

Predictors of provisional stenting in patients undergoing lower extremity arterial interventions remain unclear. We performed an ad hoc analysis on the predictors of provisional stenting during infrainguinal arterial percutaneous interventions using data from the Percutaneous Lower Extremity Arterial Interventions Using Primary Balloon Angioplasty versus Silverhawk Atherectomy (SA) and Adjunctive Balloon Angioplasty trial. In the above trial, SA of infrainguinal de novo arterial lesions was shown to reduce significantly provisional stenting compared with primary percutaneous transluminal angioplasty (PTA). In this ad hoc analysis, patients were divided into two groups based on whether provisional stenting has occurred. Univariate analysis was conducted between the stent versus the no-stent group. Logistic regression (LR) analysis was performed to model for the predictors of provisional stenting. Variables included were diabetes, presence of moderate calcification (versus none to little), age, gender, hypercholesterolemia, Transatlantic Intersociety Consensus (TASC) D lesion (vs. TASC A to C), and treatment method (primary PTA vs. SA with adjunctive PTA). By LR analysis, predictors of stenting were as follows: moderate calcification (odds ratio [OR] 6.56, 95% confidence interval [CI] 1.21 to 35.56, p = 0.029), primary PTA (vs. SA) (OR 0.19, 95% CI 0.04 to 0.93, p = 0.04), and TASC D lesions (vs. A to C) (OR 0.10, 95% CI 0.01 to 0.87, p = 0.037). Provisional stenting in infrainguinal interventions is predicted by the use of primary PTA, presence of moderate calcification, and TASC D lesions after controlling for gender, age, hypercholesterolemia, and diabetes.

In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.

PURPOSE: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). METHODS: Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated. RESULTS: Procedural success (<30% residual narrowing) was achieved in 359 (97.3%) patients receiving bivalirudin. Adverse events included stroke (1, 0.3%), acute renal failure (1, 0.3%), major bleeding (3, 0.8%), distal embolization (11, 3.0%), vascular access complications (2, 0.5%), and minor amputation (2, 0.5%). CONCLUSION: Bivalirudin had an excellent safety profile in a real-life cohort of patients undergoing PPI, including high-risk patients with critical limb ischemia and TASC D lesions. In-hospital major bleeding and other adverse events were infrequent. A randomized trial of bivalirudin versus UFH is needed to verify these results and establish bivalirudin as a standard anticoagulant in PPI.

The impact of severe distal left main disease on target lesion revascularization in patients with trifurcating coronary artery disease receiving the paclitaxel drug-eluting stent.

BACKGROUND: The presence of severe left main (LM) disease has been shown to adversely influence the outcome of patients undergoing percutaneous treatment of bifurcating LM disease. LM trifurcating coronary artery disease (LMTCAD) is even more complex and challenging to treat. The present article reports on the immediate and midterm outcomes of patients with severe LM disease treated with the paclitaxel drug-eluting stent for LMTCAD. METHODS: Consecutive patients (n=52) who underwent LM trifurcating stenting with the paclitaxel drug-eluting stent at the Genesis Medical Center (Iowa, USA) over a two-year period were divided into two groups: type A (with severe [50% or greater] LM involvement including trifurcating branches) and type B (with no LM involvement but involving the trifurcating branches). Demographic, clinical, procedural and midterm clinical outcomes were reviewed. Angiograms were analyzed by an operator who was blinded to patient histories. The primary end point of the study was target lesion revascularization (TLR) on follow-up. Descriptive and univariate analyses were performed, and survival curves were plotted to compare the two groups. RESULTS: Demographic and clinical variables were identical in both groups. Type A lesions required significantly more stents to treat than type B lesions (4.13±1.78 versus 2.33±1.22; P=0.001). The techniques to treat both lesions were considerably different, with more V stenting in type B and more Y stenting in type A. The TLR rate was 64.3% in type A versus 18.2% in type B (P=0.005). On follow-up, one patient with type B disease had sudden death, possibly related to stent thrombosis. CONCLUSION: Severe LM disease has a significant adverse impact on TLR in patients with LMTCAD. Given the high TLR rate, bypass surgery needs to be considered as first-line therapy in patients with type A trifurcating coronary artery disease.