Cryoplasty as Endovascular Treatment in the Femoropopliteal Region: Hemodynamic Results and Follow-up at One Year

Gonzalo, Begoña; Solanich, T.; Bellmunt, Sergi; Herranz, Carolina; González, Elena; Arnedo, Gemma; Muñoz, Gloria; Florit, Salvador; Hospedales, Jaime; Lloret, María Dolores; Vallespín, Joaquín; Giménez, Antonio

doi:10.1016/j.avsg.2009.08.021

Cited by 8 publications

(2 citation statements)

References 23 publications

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“…Cryoplasty seems not beneficial in the femoropopliteal area. 104,105 Cutting balloons have a short design thereby limiting their use in long lesions of the SFA. Use of the excimer laser has been shown to be effective in CLI, 106,107 however there is no evidence of superiority compared to conventional angioplasty or subintimal angioplasty in CLI.…”

Section: Drug-eluting Balloon Cryoplasty Cutting Balloon Excimer Lmentioning

confidence: 99%

Chapter IV: Treatment of Critical Limb Ischaemia

Setacci

Donato

Teraa

et al. 2011

European Journal of Vascular and Endovascular Surgery

132

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Recommendations stated in the TASC II guidelines for the treatment of peripheral arterial disease (PAD) regard a heterogeneous group of patients ranging from claudicants to critical limb ischaemia (CLI) patients. However, specific considerations apply to CLI patients. An important problem regarding the majority of currently available literature that reports on revascularisation strategies for PAD is that it does not focus on CLI patients specifically and studies them as a minor part of the complete cohort. Besides the lack of data on CLI patients, studies use a variety of endpoints, and even similar endpoints are often differentially defined. These considerations result in the fact that most recommendations in this guideline are not of the highest recommendation grade. In the present chapter the treatment of CLI is not based on the TASC II classification of atherosclerotic lesions, since definitions of atherosclerotic lesions are changing along the fast development of endovascular techniques, and inter-individual differences in interpretation of the TASC classification are problematic. Therefore we propose a classification merely based on vascular area of the atherosclerotic disease and the lesion length, which is less complex and eases the interpretation. Lesions and their treatment are discussed from the aorta downwards to the infrapopliteal region. For a subset of lesions, surgical revascularisation is still the gold standard, such as in extensive aorto-iliac lesions, lesions of the common femoral artery and long lesions of the superficial femoral artery (>15 cm), especially when an applicable venous conduit is present, because of higher patency and limb salvage rates, even though the risk of complications is sometimes higher than for endovascular strategies. It is however more and more accepted that an endovascular first strategy is adapted in most iliac, superficial femoral, and in some infrapopliteal lesions. The newer endovascular techniques, i.e. drug-eluting stents and balloons, show promising results especially in infrapopliteal lesions. However, most of these results should still be confirmed in large RCTs focusing on CLI patients. At some point when there is no possibility of an endovascular nor a surgical procedure, some alternative non-reconstructive options have been proposed such as lumbar sympathectomy and spinal cord stimulation. But their effectiveness is limited especially when assessing the results on objective criteria. The additional value of cell-based therapies has still to be proven from large RCTs and should therefore still be confined to a research setting. Altogether this chapter summarises the best available evidence for the treatment of CLI, which is, from multiple perspectives, completely different from claudication. The latter also stresses the importance of well-designed RCTs focusing on CLI patients reporting standardised endpoints, both clinical as well as procedural.

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Section: Drug-eluting Balloon Cryoplasty Cutting Balloon Excimer Lmentioning

confidence: 99%

Chapter IV: Treatment of Critical Limb Ischaemia

Setacci

Donato

Teraa

et al. 2011

European Journal of Vascular and Endovascular Surgery

132

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“…While these initial reports appeared to show promise for cryoplasty, there has been some evidence to show that cryoplasty is not efficacious in the treatment of infrainguinal arterial occlusive disease. A series from Gonzalo et al 14 demonstrated 55% primary patency and freedom from re-stenosis at one year after cryoplasty in the femoropopliteal distribution.…”

Section: Discussionmentioning

confidence: 99%

Cryoplasty offers no advantage over standard balloon angioplasty for the treatment of in-stent stenosis

et al. 2013

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In-stent restenosis is the primary failure mode of endovascular treatment of occlusive disease in the femeropopliteal segment. Cryoplasty has been proposed to reduce intimal hyperplasia through induction of apoptosis. We sought to evaluate the efficacy of cryoplasty for treatment of in-stent restenosis compared to conventional balloon angioplasty (CBA). After IRB approval, a retrospective record review was performed of reinterventions for in-stent restenosis by a single vascular surgery group at a university hospital. Reinterventions involving cryoplasty and CBA were evaluated at 1, 3, 6 and 12 months after intervention with duplex imaging to identify significant recurrent stenosis utilizing established velocity criteria. Data collected included basic demographic information and comorbidities as well as time to restenosis. Statistical analysis was performed using Kaplan–Meier survival curves with the log rank test, Wilcoxon rank test, and Cox proportional hazards models. From December 2004 to November 2007, 76 reinterventions were performed using CBA (n = 39) or cryoplasty (n = 37) for in-stent restenosis without placement of additional stents. Periprocedural technical success (>30% residual stenosis) was 100% for both groups, with no complications. The two cohorts were statistically similar in mean age, gender, comorbidities, tobacco use and use of statins, aspirin and Plavix. However, the mean lesion length was significantly longer in the cryoplasty cohort (CBA: 140.9 mm, Cyro: 191.7 mm; P = 0.032). The mean time to recurrent stenosis or need for additional secondary intervention was significantly shorter for the cyroplasty cohort than for the CBA, 4.09 and 10.79 months, respectively (P = .0001). Recurrent stenosis-free survival was significantly lower in the cyroplasty cohort at 3 months (CBA: 96.9%, Cyro: 88.9%) and 6 months (CBA: 84.0%, Cyro: 43.8%; P = .0089). Cyroplasty as a modality for treatment of in-stent stenosis in the femoropopliteal segment offers no benefit over CBA.

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