Faculty Bibliography

BACKGROUND: Peripartum cardiomyopathy (PPCM) is the onset of acute heart failure without demonstrable cause during the last month of pregnancy or within five months after delivery. The purpose of this study was to create a prospective registry of PPCM patients with the assistance of the internet and identify clinical factors predictive of ejection fraction (EF) recovery. METHODS: Patients with PPCM were identified by novel web-based methods. Subjects were categorized as recovered (EF>50) or nonrecovered (EF<50) and compared on the basis of demographic and clinical variables. RESULTS: Fifty-five subjects met criteria for inclusion. There was a statistically significant association between diagnosis during third trimester and persistent systolic dysfunction (25% vs. 4.7%, p=0.03). Gestational hypertension and breastfeeding were significantly associated with EF recovery (48.8% vs. 16.7%, p=0.046, and 39.5% vs. 8.3%, p=0.04, respectively). EF normalization occurred in all patients with EF(1)>/=35%. CONCLUSIONS: Presence of gHTN, EF>/=35% at diagnosis, breastfeeding, and postpartum diagnosis were all significantly associated with recovery of systolic function. Internet recruitment may be a valuable tool for studying PPCM

The Diamondback 360(R) Orbital PAD System (DB360) is a novel orbital atherectomy system for the treatment of calcified lower extremity lesions associated with peripheral arterial disease (PAD). This percutaneous, endovascular system incorporates the use of centrifugal force and differential sanding to modify plaque morphologies. The mechanism of differential sanding discriminates between compliant arterial tissue and diseased fibro-calcific or calcific plaque. An eccentrically mounted diamond-coated crown orbits at high speeds and removes a thin layer of calcific plaque with each pass of the crown. The crown creates a more concentric, smooth vessel lumen with increased diameter, increased lesion compliance and improved blood flow while protecting the vessel media. As a result, the risk for post-procedure thrombus formation and potential for restenosis may be reduced. The risk of intra-procedural events (slow flow, hemolysis, spasm and pain) may be reduced due to the design of this orbital sanding system along with proper technique. Extensive benchtop, in vivo, and clinical testing has confirmed these results and is presented within this paper. In addition, guidelines for selecting the most appropriate crown size and type (solid versus classic) and step-by-step procedural technique and pharmacology information are presented. The DB360 System provides a safe, efficacious, and cost-effective endovascular method for PAD treatment. Careful understanding of procedural methods, use of pharmacological drugs, and understanding of device operation contributes to improved treatment success

Purpose: To evaluate the incidence of clinically evident hemolysis associated with orbital atherectomy used to treat severe peripheral artery disease. Methods: The observational CLEAR study enrolled 31 subjects (16 men; mean age 71+/-10 years, range 44-92) with claudication (58.1%) or critical limb ischemia (38.7%) who underwent orbital atherectomy with the Diamondback 360 system at 4 US centers. The 42 lesions in 31 limbs were located in the superficial femoral (n = 19, 45.2%), popliteal (n = 8, 19.0%), and tibial arteries (n = 15, 35.8%). The majority of lesions (34, 81.0%) were de novo; moderate or severe calcification was identified in 90.5% of cases. Lesion and procedural parameters were analyzed at a core laboratory. Blood samples were collected during and post procedure and analyzed for markers of hemolysis. The primary endpoint was the occurrence of clinically significant hemolysis. The secondary endpoints included the occurrence of any clinical symptoms/signs potentially related to hemolysis. Statistical analysis was performed to identify predictors for hemolysis. Results: Laboratory evidence of hemolysis was seen in 11 (35.5%) subjects. No one met the clinical event criteria, and so the primary endpoint of the study was not reached. The secondary endpoints were hypertensive crisis (1, 3.2%) and transient hemoglobinuria (3, 9.7%). Lower glomerular filtration rates, calcified plaque, long atherectomy runs, and solid crown selection were independent predictors of hemolysis. Conclusion: There was no clinically significant hemolysis after orbital atherectomy. The results of this study will enable users to predict conditions that predispose to high levels of red cell hemolysis following orbital atherectomy and to take appropriate measures to limit its occurrence

PURPOSE: Revascularization of lower extremity chronic total occlusions (CTOs) is technically challenging. The Crosser(R) recanalization catheter was designed to facilitate distal vessel intraluminal entry that is both rapid and safe. We present our experience with the Crosser device as primary therapy for peripheral CTOs. METHODS: Subjects undergoing evaluation for arterial insufficiency at our institution between 2008-2010 who were noted to have a CTO in the lower extremity by duplex ultrasonography and who subsequently underwent Crosser recanalization were enrolled. Clinical characteristics, ankle-brachial indices, Rutherford-Becker symptom category, and angiographic CTO parameters were collected. Primary technical success was intraluminal delivery of the guidewire into the distal vessel solely by the Crosser device. Secondary technical success was assisted delivery using the Outback LTD(R) re-entry device. Safety endpoints were the occurrence of dissections, thromboembolism, and perforations related to the Crosser device. Statistical analysis was performed to find independent predictors for failure to achieve Crosser recanalization. RESULTS: Fifty-six subjects with 73 CTOs were enrolled. The mean Crosser use time was 17.6 +/- 12.7 minutes. The overall primary and secondary technical success rates for Crosser recanalization were 76.7% and 87.7%, respectively. Technical success was highest for CTOs located in the aorto-iliac (90.0%) and tibial (95.2%) arterial segments. There were no perforations related to the Crosser device. For successful cases, the mean ABI improved significantly from pre- to post-intervention (0.57 +/- 0.13 to 0.89 +/- 0.15, p < 0.001). The only predictors for failure were lesion length longer than 100 mm (p = 0.04) and calcification within 10 mm of the exit cap (p = 0.02). CONCLUSION: The Crosser device is safe and shows excellent efficacy in facilitating guidewire distal lumen entry, especially for aorto-iliac and tibial occlusions. The technical success rate for the femoral and popliteal occlusions is comparable to those reported with other recanalization techniques

BACKGROUND: Plaque-debulking technologies have been proposed as alternative treatment options for peripheral arterial disease. Orbital atherectomy (OA), using the DiamondBack360 device, has emerged as one promising modality. METHODS: We evaluated the safety and efficacy of OA in the first 200 lesions treated at our institution. Patient demographics, clinical characteristics, and lesion and procedural variables were collected and analyzed. The primary safety endpoint was the 30-day major adverse events (MAE), including death, myocardial infarction, stroke, unplanned amputation, or target lesion revascularization. Other safety endpoints included access-site complications, occurrence of dissections, perforations, distal embolization, spasm, and hemolysis. The efficacy endpoints were procedural success, need for adjunctive therapy, and improvement in ankle-brachial index. Multivariate analysis was performed to find independent predictors of the safety endpoints. RESULTS: One hundred seventeen (58.5%) lesions were femoral, 31 (15.5%) were popliteal, and 52 (26.0%) were tibial. The procedural success (residual stenosis </=30%) was comparable between the femoral and tibial lesions (86.3% vs. 92.5%, P = 0.18), but significantly lower for the popliteal lesions when compared with femoral and tibial (64.7% vs. 86.3%, P = 0.058, and 64.7% vs. 92.5%, P = 0.007 respectively). MAE at 30-days occurred in 3 (2.2%) procedures, and major access-site complications also occurred in 3 (2.2%). There were 31 (15.5%) dissections; independent predictors were diabetes mellitus (OR: 7.3, P = 0.008), crown-to-RVD ratio <0.6 (OR: 11.6, P = 0.005), and atherectomy time >360 sec (OR: 11.8, P = 0.001). There were 2 (1.0%) distal embolizations, 6 (3.0%) arterial spasms, and no perforations. Laboratory evidence of hemolysis was noted in 33.8% of cases. CONCLUSION: Orbital atherectomy allows for a significant procedural success, limited need for stenting, and favorable safety profile

BACKGROUND: Subclavian artery angioplasty has been traditionally performed via the transfemoral approach. Transradial access is becoming increasingly used for coronary as well as for certain peripheral vascular beds. We describe our experience with transradial access for subclavian artery stenting. METHODS: We performed a retrospective review of subclavian artery interventions from 2007 to 2009 at our institution. Demographics, clinical data, lesion and procedural characteristics were collected. Safety and efficacy endpoints were recorded, and follow-up was performed at 1 year post intervention. Descriptive statistics were used to analyze the data. RESULTS: Fourteen cases of subclavian artery stenting, including 5 total occlusions, were performed using transradial access. The procedural success was 93%, and there were no complications recorded. All patients remained symptom-free at 1-year follow up. CONCLUSIONS: Subclavian artery stenting can be safely performed via transradial access with success rates comparable to the transfemoral approach

BACKGROUND: This study compares transradial approach (TRA) aortoiliac angioplasty/stenting to the transfemoral approach (TFA). METHODS: We reviewed our peripheral database for aortoiliac interventions performed between 2007 and 2009. Demographics, clinical characteristics, procedural, and lesion details were collected. The efficacy endpoints included procedural success, ankle-brachial index (ABI) improvement, and time to discharge. The safety endpoints were as follows: occurrence of intra-/periprocedural complications, 30-day MACE, and access-site complications (minor/major). The subjects were divided into two groups, TRA and TFA, and compared using appropriate statistics. RESULTS: Twenty-seven patients had 33 lesions treated via TRA, and 41 patients had 47 lesions treated via TFA access. Baseline demographic differences between the TRA and TFA groups were similar, including mean Rutherford category (2.9 vs. 2.6, P = 0.31) and preintervention ABI (0.64 vs. 0.67, P = 0.80). There was a significantly higher percentage of total occlusions in the TRA group (27.3 vs. 8.5%, P = 0.03). Dye use (238 vs. 213 mL, P = 0.35) and fluoroscopy time (30 vs. 27 min, P = 0.60) were similar. Procedural success rate was similar (87.9 vs. 97.8%, P = 0.15), as well as the improvement in mean ABI (TRA: 0.64-0.77 and TFA: 0.67-0.85, P = 0.77). The time to discharge was significantly shorter for the TRA group (14.4 vs. 20.9 hr, P = 0.003). There were no 30-day MACE or major access-site complications, but minor access-site complications were lower in the TRA group (0.0 vs. 7.3%, P = 0.28), although nonsignificant. CONCLUSIONS: The TRA to aortoiliac interventions is as safe and effective as the TFA with the advantage of a lower rate of access-site complications and shorter hospitalization time

Percutaneous interventions of the coronary and peripheral vessels have historically been performed using a femoral artery approach. There has been increasing recognition of post-procedural bleeding complications and its impact on short- and long-term mortality. Because of its now recognized safety, the transradial approach has recently emerged as a preferred method compared to the transfemoral approach. The limitations associated with the distance from the puncture site to the lesion location are being addressed as new tools are developed for the endovascular treatment of peripheral arterial disease. In this review, we discuss the many facets of the transradial approach to lower extremity endovascular interventions, highlighting its safety and efficacy. Approaches to special populations including individuals with prior surgical bypass, Leriche's syndrome, and those committed to chronic anticoagulation are also reviewed

Introduction: Endovascular therapy using the Diamondback 360 orbital atherectomy system (