Initial experience with the 5 × 300-mm Proteus embolic capture angioplasty balloon in the treatment of peripheral vascular disease. 2012

Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany. thomas.zeller@herzzentrum.de

OBJECTIVE To describe the use of the 5 × 300-mm Proteus embolic capture angioplasty (ECA) balloon catheter to reduce embolic burden in complex TASC II (TransAtlantic Inter-Society Consensus) C and D femoropopliteal interventions. METHODS A non-randomized safety and feasibility study was conducted at 2 centers enrolling 15 subjects (9 women; mean age 72.5 ± 9.5 years, range 53-85) suffering from Rutherford-Becker category 2 to 4 occlusive disease. Of the 20 lesions in 15 limbs, 16 were TASC II D and 4 were TASC II C. Average baseline stenosis was 95%± 12%; 16 lesions were totally occluded. Half of the lesions were de novo, 5 were restenotic, and 5 were in-stent stenoses. Average lesion length was 284 ± 50 mm. In addition to using the ECA device, 18 of the target lesions were treated with stents and 4 with rotational thrombectomy devices. Distal angiography was performed before and after use of the ECA device to locate any periprocedural embolic events. RESULTS Procedural success was achieved in 100% lesions. The ECA balloon was used for predilation in 11 lesions and for postdilation in 9. No distal embolization or flow-limiting vessel dissections were observed despite the complex nature of the cases. Three non-device-related complications were reported (pseudoaneurysm, myocardial infarction, acute renal failure) and resolved without sequelae within 30 days. Analysis of the particles recovered from 5 ECA balloons demonstrated a mean 257 ± 185 particles, with a mean major axial dimension of 0.54 ± 0.04 mm (range 0.11-7.54). There were a mean 7.67 ± 6.03 particles >2 mm in diameter, and all samples contained 1 to 3 particles >4 mm in diameter. CONCLUSIONS In this small series, the 5 × 300-mm ECA embolic capture balloon catheter was an effective tool for avoiding embolic events in long peripheral lesions, with a good safety profile. The device might be considered as part of routine clinical practice for complex TASC II C/D femoropopliteal lesions.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011474 Prosthesis Design The plan and delineation of prostheses in general or a specific prosthesis. Design, Prosthesis,Designs, Prosthesis,Prosthesis Designs
D012008 Recurrence The return of a sign, symptom, or disease after a remission. Recrudescence,Relapse,Recrudescences,Recurrences,Relapses
D004617 Embolism Blocking of a blood vessel by an embolus which can be a blood clot or other undissolved material in the blood stream. Embolus,Embolisms
D005240 Feasibility Studies Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project. Feasibility Study,Studies, Feasibility,Study, Feasibility
D005260 Female Females
D005858 Germany A country in central Europe, bordering the Baltic Sea and the North Sea, between the Netherlands and Poland, south of Denmark. The capital is Berlin.
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly

Related Publications

Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
April 2013, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
December 2012, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
June 1990, Postgraduate medicine,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
January 1982, The Journal of cardiovascular surgery,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
October 2012, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
October 2012, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
July 2008, Radiology,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
September 1989, Archives of surgery (Chicago, Ill. : 1960),
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
May 1987, The Australian and New Zealand journal of surgery,
Thomas Zeller, and Andrej Schmidt, and Aljoscha Rastan, and Elias Noory, and Sebastian Sixt, and Dierk Scheinert
September 1996, Iowa medicine : journal of the Iowa Medical Society,
Copied contents to your clipboard!