Primary Cryoplasty Therapy Provides Durable Support for Limb Salvage in Critical Limb Ischemia Patients With Infrapopliteal Lesions:<b>12-month Follow-up Results From the BTK Chill Trial</b>

Das, Tony; McNamara, Thomas O.; Gray, Bruce H; Sedillo, Gino J.; Turley, Brian R.; Kollmeyer, Kenneth; Rogoff, Michael; Aruny, John E.

doi:10.1583/08-2652.1

Cited by 32 publications

(27 citation statements)

References 49 publications

(86 reference statements)

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“…In contrast, 12-month follow-up results from the BTK Chill Trial, which evaluated cryoplasty in the infrapopliteal arteries of CLI patients, reported high rates of acute technical success and major amputation-free interval (97.3% and 78.5%, respectively) followed by a low percentage of clinically driven repeat procedures (21% at 12 months) [41]. Almost 70% of the patients had diabetes.…”

Section: Discussionmentioning

confidence: 93%

Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial

Spiliopoulos

Katsanos

Karnabatidis

et al. 2010

Cardiovasc Intervent Radiol

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The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as \30% residual stenosis without any adjunctive stenting. Primary end points included technical success, primary patency, binary in-lesion restenosis ([50%), and freedom from target lesion recanalization. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA (p = 0.29). According to 3-year Kaplan-Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. 92.1% in groups CRYO and COBA, respectively, p = 0.60). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio [HR] 1.3; 95% CI 0.6-2.6, p = 0.45). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2; 95% CI 1.1-4.3, p = 0.02). Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5; 95% CI 1.2-5.3, p = 0.01). Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.

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Section: Discussionmentioning

confidence: 93%

Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial

Spiliopoulos

Katsanos

Karnabatidis

et al. 2010

Cardiovasc Intervent Radiol

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“…5 In the case above, excellent angiographic and hemodynamic results were achieved in a diffusely diseased ATA with laser atherectomy lesion debulking followed by cryoplasty.…”

Section: Case 2: Cryoplasty For Infrapopliteal Stenosis/occlusionmentioning

confidence: 84%

“…A secondary revascularization procedure within 365 days was performed in 21.0% (17/81) of treated limbs. 5 The Cryoplasty Device: Specification and Basic Technique…”

Section: Cryoplasty In the Peripheral Vasculaturementioning

confidence: 99%

The Role for Cryoplasty in the Treatment of Infrainguinal Artery Disease:Case Studies

Laird

Dawson

2009

Journal of Endovascular Therapy

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Cryoplasty has been shown to be safe and effective for the treatment of atherosclerotic lesions in the peripheral vasculature and offers the promise of improving on the results of percutaneous transluminal angioplasty (PTA) by limiting dissection, vessel recoil, and restenosis. The PolarCath Peripheral Dilatation System utilizes nitrous oxide rather than the standard mixture of saline and contrast medium to inflate and cool the balloon to the desired temperature of approximately -10 degrees C. Cryoplasty can be used in combination with other therapies, can be repeated, and offers the advantage of not leaving any foreign objects in the body. In a multicenter registry of claudicants with de novo or restenotic femoropopliteal lesions and in a multicenter trial of CLI patients with infrapopliteal lesions (86.9% mean diameter stenosis, 33.9% occlusions), favorable results with primary cryoplasty included minimal need for bailout stenting, avoidance of repeat revascularization, and high amputation-free survival. We review cases in which cryoplasty was used for diffuse superficial femoral and popliteal artery disease, for infrapopliteal stenosis and occlusion, for in-stent restenosis, and as part of a hybrid strategy for treating multilevel occlusive disease. As these clinical cases demonstrate, cryoplasty therapy can be employed effectively as a primary strategy, or in conjunction with debulking, for the treatment of lesions of varying severity in different segments of the infrainguinal vasculature. Further studies will be required to better define the role of this therapy relative to the other modalities that are currently available for the treatment of femoropopliteal and infrapopliteal disease.

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“…28 Follow-up of this initial group was extended and revealed durable results, with freedom from target lesion revascularization of 75% at 1,253 days. 29 The BTK Chill trial studied primary cryoplasty of BTK occlusive disease in CLI patients and yielded similar results. 28 (2) Cutting Balloon Angioplasty Resistant and bifurca- …”

Section: Alternative Angioplasty Technologiesmentioning

confidence: 93%

Advances in Endovascular Treatment of Critical Limb Ischemia

Yan

Moran

Hynes

et al. 2011

Circ J

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Critical limb ischemia (CLI) represents the most severe clinical manifestation of peripheral arterial disease. In the absence of timely revascularization, CLI carries high risk of mortality and amputation. Over the past decade, endovascular revascularization has rapidly become the preferred primary treatment strategy for CLI, especially for the treatment of below-the-knee disease. Advances in percutaneous devices and techniques have expanded the spectrum of patients with CLI who are deemed candidates for revascularization. This review will focus on advances in endovascular options for the treatment of CLI, in particular for below-the-knee disease. (Circ J 2011; 75: 756 - 765)

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Primary Cryoplasty Therapy Provides Durable Support for Limb Salvage in Critical Limb Ischemia Patients With Infrapopliteal Lesions:12-month Follow-up Results From the BTK Chill Trial

Cited by 32 publications

References 49 publications

Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial

Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial

The Role for Cryoplasty in the Treatment of Infrainguinal Artery Disease:Case Studies

Advances in Endovascular Treatment of Critical Limb Ischemia

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