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Multicenter Study
. 2014 Jan 1;83(1):115-22.
doi: 10.1002/ccd.25046. Epub 2013 Oct 7.

Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry

Tony Das  1 , Jihad Mustapha, Jeffrey Indes, Robert Vorhies, Robert Beasley, Nilesh Doshi, George L Adams
Affiliations
Free PMC article
Multicenter Study

Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry

Tony Das et al. Catheter Cardiovasc Interv. .
Free PMC article

Abstract

Objectives: The purpose of CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA.

Background: Methods of treating calcified arteries (historically a strong predictor of treatment failure) have improved significantly over the past decade and now include minimally invasive endovascular treatments, such as OA with unique versatility in modifying calcific lesions above and below-the-knee.

Methods: Patients (3135) undergoing OA by more than 350 physicians at over 200 US institutions were enrolled on an "all-comers" basis, resulting in registries that provided site-reported patient demographics, ABI, Rutherford classification, co-morbidities, lesion characteristics, plaque morphology, device usage parameters, and procedural outcomes.

Results: Treatment with OA reduced pre-procedural stenosis from an average of 88-35%. Final residual stenosis after adjunctive treatments, typically low-pressure percutaneous transluminal angioplasty (PTA), averaged 10%. Plaque removal was most effective for severely calcified lesions and least effective for soft plaque. Shorter spin times and smaller crown sizes significantly lowered procedural complications which included slow flow (4.4%), embolism (2.2%), and spasm (6.3%), emphasizing the importance of treatment regimens that focus on plaque modification over maximizing luminal gain.

Conclusion: The OA technique optimization, which resulted in a change of device usage across the CONFIRM registry series, corresponded to a lower incidence of adverse events irrespective of calcium burden or co-morbidities.

Keywords: clinical study; endovascular intervention; limb ischemia; peripheral arterial disease; plaque morphology; vascular calcification.

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Figures

Fig. 1
Fig. 1
Diamondback 360° Orbital Atherectomy System. [Color figure can be viewed in the online issue, which is available at http://wileyonlinelibrary.com.]
Fig. 2
Fig. 2
Predator 360° Orbital Atherectomy System. [Color figure can be viewed in the online issue, which is available at http://wileyonlinelibrary.com.]
Fig. 3
Fig. 3
Stealth 360° Orbital Atherectomy System. [Color figure can be viewed in the online issue, which is available at http://wileyonlinelibrary.com.]
Fig. 4
Fig. 4
Mean run time (in seconds) of OAS in CONFIRM I, II, and III.
Fig. 5
Fig. 5
Crown sizes used (1.25, 1.75, and 2.25 mm) in CONFIRM I, II, and III.
Fig. 6
Fig. 6
Percentage of procedural complications, including slow flow, vessel closure, and spasm across CONFIRM series.
Fig. 7
Fig. 7
Percentage of plaque removed with OAS in CONFIRM I, II, and III.
See this image and copyright information in PMC

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