Faculty Bibliography

A number of atherectomy devices were developed in the last few years. Among them, the DiamondBack 360 degrees Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc) was specifically designed to work in severely calcified plaque. This article reviews the history, mechanism of action, evolution, clinical data, and future applications of this particular atherectomy device.

Transradial access for coronary interventions has grown substantially in the last few years. Currently, there is an increased interest in applying this approach to peripheral vascular interventions. This report reviews the current status of transradial peripheral interventions, and offers advice in terms of feasibility, equipment use, and technical challenges. (c) 2012 Wiley Periodicals, Inc.

Vascular and bleeding complications are a known risk of cardiac catheterization. In this article, we report a neck hematoma after left-sided transradial cardiac catheterization, which is a known but rarely reported complication of this procedure.

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

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

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