Treatment Of Femoropopliteal Artery Disease Research Articles

Cryoplasty for the Treatment of Femoropopliteal Arterial Disease: Extended Follow-up Results

To report the findings from a multicenter study of patients treated with cryoplasty who were then followed for an average of > 2 years post-treatment. Extended clinical follow-up was obtained for 70 patients (45 men; mean age 70.5 +/- 8.8 years) who originally received cryoplasty therapy to treat symptoms of intermittent claudication as part of a multicenter investigational device exemption (IDE) study. For all subjects, cryoplasty was used to treat stenoses or occlusions < or = 10 cm in the femoropopliteal arteries. The original IDE study protocol enrolled 102 patients with a primary endpoint of target lesion patency at 9 months post-treatment. This collection of additional longer term follow-up data was initiated 2.5 years after the onset of study enrollment. Extended clinical follow-up ranged from 11 to 41 months (mean 31). The clinical patency rate (freedom from target lesion revascularization) calculated by the Kaplan-Meier method was 83.2% after the original follow-up period of 300 days. After > 3 years (1253 days), the clinical patency rate was well maintained at 75.0%. Long-term data indicate that cryoplasty is a durable therapy, with relatively low long-term restenosis rates compared to other endovascular treatment approaches.

Cryoplasty for the Treatment of Femoropopliteal Arterial Disease: Results of a Prospective, Multicenter Registry

Despite suboptimal results, angioplasty of femoropopliteal arterial lesions has been a mainstay of endovascular therapy for many years. The recent introduction of cryoplasty marks a potential advance in the ability to effectively treat peripheral arterial atherosclerotic stenoses. This article presents the results of a prospective, multicenter trial that evaluated the efficacy of cryoplasty for femoropopliteal disease. One hundred two patients with claudication and lesions of the superficial femoral and popliteal arteries of no greater than 10 cm were studied. All patients were treated with a primary strategy of stand-alone cryoplasty with use of the PolarCath cryoplasty system. The primary endpoints of the study were acute technical success and clinical patency at 9 months. Technical success was defined as the ability to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. Clinical patency was defined as freedom from target lesion revascularization within 9 months. Primary patency was defined by a duplex US systolic velocity ratio no greater than 2.0. A total of 102 patients were enrolled at 16 centers. Of those treated, 31% had diabetes and 31% were active cigarette smokers. The majority of the lesions were confined to the superficial femoral artery (84.3%) and 14.7% presented with total occlusions. The mean vessel diameter treated was 5.5 mm +/- 0.5, the mean stenosis diameter was 87% +/- 10%, and the mean lesion length was 4.7 cm +/- 2.6. The technical success rate was 85.3% with a mean residual stenosis after cryoplasty of 11.2% +/- 11.2% (P < .05 vs baseline). Clinical patency in this group was 82.2%, as only 16 patients required target lesion revascularization during the 9-month surveillance period. Primary patency determined by duplex US was 70.1%. Cryoplasty demonstrated a high degree of acute angiographic success and a low frequency of target lesion revascularization. The patency rate observed compares favorably to that previously documented with conventional angioplasty.

Cryoplasty for the Treatment of Femoropopliteal Arterial Disease: Will Freezing Solve the Problem of Cold Feet?

IN patients with symptomatic femoropopliteal arterial disease, percutaneous transluminal angioplasty (PTA) has been established as the first-line treatment for the majority of atherosclerotic lesions. A significant drawback of the procedure is the high rate of recurrent stenosis, which usually develops during the first 12 months after treatment (1). Initial failure of PTA caused by elastic recoil or hemodynamically relevant dissection can be managed by the implantation of stents, but clinical and experimental studies have shown that angioplasty triggers multiple cellular and molecular mechanisms that lead to a cascade of events that eventually results in increased vascular smooth muscle cell proliferation, synthesis of extracellular matrix, and consecutive formation of neointimal hyperplasia with luminal narrowing. Although stents may dramatically improve the appearance immediately after angioplasty, they have yet failed to show superior long-term efficacy, as intimal hyperplasia is even more pronounced after stent implantation than after PTA alone (2,3). In this respect, the search for new techniques and devices dedicated to endovascular management of peripheral artery disease is a contemporary issue and has to be continued. Each year, a vast number of experimental and clinical studies are performed to test refinements of current balloon/stent systems or to explore new and more innovative techniques for transluminal treatment of femoropopliteal obstructions. However, most of the new devices and strategies fail to show significant improvements in long-term outcome when finally introduced into clinical practice. Recanalization techniques like atherectomy (rotational and directional), excimer laser–assisted angioplasty, or subintimal angioplasty mainly address the appearance of the vessel immediately after angioplasty. Transluminal removal of the atherosclerotic plaque and/or creation of a subintimal channel results in a wider lumen (or neolumen) with a relatively smooth surface, while the profound vessel wall trauma of balloon angioplasty is avoided (4–7). However, the efficacy of these techniques in terms of reduction of neointimal hyperplasia has not been determined for treatment of femoropopliteal arterial disease. The same is true for cutting balloon angioplasty, which represents a modification of conventional balloon dilation. The cutting blades of the balloon make controlled longitudinal incisions into the plaque and reduce the force needed to dilate the vessel. This is thought to result in lower rates of dissection and to trigger a more benign course of arterial healing as a result of the limited stretch injury. Although cutting balloon angioplasty has been positively evaluated in the coronary circulation, there are few reports about its use for peripheral vessels (8). During the past two decades, nearly all available stent designs— mostly variations of balloon-expandable devices and thermal or self-expanding cobalt or nickel titanium alloy (ie, nitinol) systems—have been used at the femoropopliteal level for salvage of PTA or even off-label primary treatment. However, in randomized studies, stents have generally failed to prove a significant benefit when evaluated versus PTA alone (9). The fact that the stent design can have significant impact on neointimal thickness independently of the extent of stretch injury has been demonstrated by Garasic et al (10), thereby finding that the optimal structure for these devices might be a key requirement for restenosis prevention. Recent investigations have highlighted the various forces that affect a stent when implanted into the femoropopliteal artery. In this territory, a combination of stresses like longitudinal extension, torsion, flexion at the popliteal level, and muscle compression in the adductor channel are encountered that may significantly influence long-term success (11). Newer generations of nitinol self-expanding coil and mesh stents, which seem to provide the necessary flexibility in multiple dimensions, appear to have a positive impact on femoropopliteal patency, but this notion has not been confirmed in a randomized setting (12–14). Fabric-covered From the Department of Radiology, University Clinics Schleswig-Holstein, Campus Kiel, Arnold-Heller Str. 9, 24105 Kiel, Germany. Address correspondence to T.J.; E-mail: jahnke@medscape.com

Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis.

To perform a meta-analysis of long-term results of balloon dilation and stent implantation in the treatment of femoropopliteal arterial disease. The English-language literature was searched for studies published between 1993 and 2000. Inclusion criteria for articles were presentation of long-term primary patency rates, standard errors (explicitly reported or derivable), and baseline characteristics of the study population. Two reviewers independently extracted data, and discrepancies were resolved by consensus. Primary patency rates were combined by using a technique that allows adjustment for differences across study populations. Analyses were adjusted for lesion type and clinical indication. Nineteen studies met the inclusion criteria, representing 923 balloon dilations and 473 stent implantations. Combined 3-year patency rates after balloon dilation were 61% (standard error, 2.2%) for stenoses and claudication, 48% (standard error, 3.3%) for occlusions and claudication, 43% (standard error, 4.1%) for stenoses and critical ischemia, and 30% (standard error, 3.7%) for occlusions and critical ischemia. The 3-year patency rates after stent implantation were 63%-66% (standard error, 4.1%) and were independent of clinical indication and lesion type. Funnel plots demonstrated an asymmetric distribution of the data points associated with stent studies. Balloon dilation and stent implantation for claudication and stenosis yield similar long-term patency rates. For more severe femoropopliteal disease, the results of stent implantation seem more favorable. Publication bias could not be ruled out.

Recent trends in flexible automated manufacturing

Purpose: The purpose of this study was to evaluate the efficacy of angioplasty in the treatment of femoropopliteal arterial disease. Methods: From 1980 to 1991, 126 angioplasty procedures were performed in 131 limbs of 106 patients with 175 femoropopliteal lesions (26 common femoral, 118 superficial femoral, and 31 popliteal). Critical ischemia was present in 55 limbs (42%), and claudication was present in 76 (58%). Angioplasty was performed for a single lesion in 87 limbs (66%) and for multiple lesions in 44 (34%). In 13 limbs (10%) the most severe lesion was an occlusion; in 118 (90%) all lesions were stenoses. Distal runoff was good (2 or 3 vessels patent) in 72 limbs (55%) and poor (0 or 1 vessel patent) in 59 (45%). Results: Death within 30 days occurred in 0.8%, nonfatal systemic morbidity in 7.1%, and local morbidity in 1.6% of procedures. Multivariate analysis revealed that indication and age were predictive of increased morbidity and mortality rates. Immediate success was achieved in 95% of limbs treated. Mean follow-up time was 2.0 years. The overall 5-year cumulative primary patency rate was 45% (± 5%). In a proportional hazards model indication and lesion type were predictive (p < 0.01) of long-term failure, with relative risks of 2.0 (1.2 to 3.3) and 2.7 (1.3 to 5.6), respectively. The 5-year primary patency rate after angioplasty for stenoses and claudication was 55% (± 7%), for stenoses and critical ischemia it was 29% (± 11%), and for occlusions it was 36% (± 14%). Conclusion: These results suggest that femoropopliteal angioplasty is a low-risk procedure with acceptable long-term results in patients with claudication and stenoses. (J VASC SURG 1993;17:183-94.)