Novel balloon technologies to minimize dissection of peripheral angioplasty

Spiliοpoulos, Stavros; Karamitros, Andreas; Reppas, Lazaros; Brountzos, Elias

doi:10.1080/17434440.2019.1626715

Cited by 13 publications

(2 citation statements)

References 26 publications

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“…17 It has been shown that post-PTA dissections are known to contribute to suboptimal results. 9,10 The Tack Endovascular System technology was intended to help optimize and potentially improve the long-term outcomes of PTA. Tacks exert a low radial force and combined with an open-cell design and smaller longitudinal length, they are designed to overcome many of the limitations of bare metal and drug-eluting stents.…”

Section: Discussionmentioning

confidence: 99%

“…Although dissections are thought to contribute to acute luminal gain following balloon angioplasty, 8 their occurrence has also been shown to predict procedural complications and restenosis, with more severe dissections associated with worse outcomes. [9][10][11] Treatment of post-PTA dissections in the infrapopliteal arteries typically involves prolonged secondary balloon inflations and/ or placement of a coronary stent, the latter of which remains off-label in the United States and is subject to fracture. [12][13][14] The Tack Endovascular System was purpose-built for focal repair of post-PTA dissections with the goal of optimizing outcomes following PTA.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries

Adams

Lichtenberg

Wissgott³

et al. 2022

J Endovasc Ther

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Purpose: To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI). Materials and Methods: The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months. Results: Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1–16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months. Conclusion: The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions. Clinical Trial Registration: ClinicalTrials.gov identifier NCT02942966.

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Section: Discussionmentioning

confidence: 99%