Literature DB >> 21725120

Tissue removal by ultrasound evaluation (the TRUE study): the Jetstream G2 system post-market peripheral vascular IVUS study.

Tejwant Singh1, Deepak Koul, Susanna Szpunar, James Torey, Jigishu Dhabuwala, Lisa Saigh, Luis A Pires, Thomas Davis.   

Abstract

BACKGROUND: Balloon angioplasty and stenting of infra-inguinal lesions is limited by poor long-term patency rates. Atherectomy decreases plaque burden and provides an alternative means of revascularizing patients with peripheral arterial disease. The Jetstream G2™ (Pathway Medical Technologies, Inc., Kirkland, Washington) is a newer rotational aspiration atherectomy device, uniquely combining rotablation with aspiration capability. We evaluated the debulking properties of this device by analyzing changes in the plaque volume and composition and vessel size using intravascular ultrasound (IVUS) and virtual histology (VH). Freedom from target lesion revascularization (TLR) at 6 and 12 months was also evaluated. METHODS AND
RESULTS: Eighteen patients with peripheral arterial disease requiring intervention (severe claudication despite optimal medical treatment or critical limb ischemia) were treated with rotational atherectomy. The mean age was 69.6 ± 11 years, 66.7% were male, and 44.4% had diabetes. The mean total plaque volume decreased by 56.6 mm³ (479.8 ± 172.5 mm³ to 423.2 ± 156.6 mm³; p < 0.0001), which resulted in a mean luminal volume increase of 64.3 mm³ (148.4 ± 84.1 mm³ to 212.7 ± 72.1 mm³; p < 0.0001). This was achieved without significant Dotter effect with either technique, as evidenced by the virtually unchanged vessel volume before and after treatment (628.3 ± 158.5 mm³ and 635.9 ± 169.0 mm³, respectively; p = 0.22). There was a significant reduction in fibrotic and fibro-fatty plaque volume, with no appreciable effect on necrotic core and dense calcium. There were no reported procedure-related complications and the 6- and 12-month TLR rate was 11% (2/18).
CONCLUSION: Atherectomy with the Jetstream G2 system results in substantial plaque volume reduction by removing fibrotic and fibro-fatty plaque. This resulted in substantial luminal volume expansion without concomitant vessel expansion. There were no major procedure-related complications, along with a relatively low 6- and 12-month rate of TLR. Future studies involving a larger number of patients are warranted to examine the potential clinical benefits of this promising technology.

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Mesh:

Year:  2011        PMID: 21725120

Source DB:  PubMed          Journal:  J Invasive Cardiol        ISSN: 1042-3931            Impact factor:   2.022


  6 in total

Review 1.  JETSTREAM Atherectomy: A Review of Technique, Tips, and Tricks in Treating the Femoropopliteal Lesions.

Authors:  Nicolas W Shammas
Journal:  Int J Angiol       Date:  2015-06

2.  Endovascular Devices and Revascularization Techniques for Limb-Threatening Ischemia in Individuals With Diabetes.

Authors:  Jayer Chung
Journal:  J Diabetes Sci Technol       Date:  2017-03-28

Review 3.  Atherectomy devices: technology update.

Authors:  Nuri I Akkus; Abdulrahman Abdulbaki; Enrique Jimenez; Neeraj Tandon
Journal:  Med Devices (Auckl)       Date:  2014-12-17

4.  Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.

Authors:  Thomas Davis; Venkatesh Ramaiah; Khusrow Niazi; Hans Martin Gissler; Tami Crabtree
Journal:  Vascular       Date:  2017-09-27       Impact factor: 1.285

Review 5.  The role of atherectomy in the treatment of lower extremity peripheral artery disease.

Authors:  Anna Franzone; Marco Ferrone; Giuseppe Carotenuto; Andreina Carbone; Laura Scudiero; Federica Serino; Fernando Scudiero; Raffaele Izzo; Raffaele Piccolo; Savio Saviano; Bruno Amato; Cinzia Perrino; Bruno Trimarco; Giovanni Esposito
Journal:  BMC Surg       Date:  2012-11-15       Impact factor: 2.102

6.  Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study).

Authors:  Anvar Babaev; Susanna Zavlunova; Michael J Attubato; Brad J Martinsen; Gary S Mintz; Akiko Maehara
Journal:  Vasc Endovascular Surg       Date:  2015-10-20       Impact factor: 1.089

  6 in total

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