Three year results of endovascular therapy with a new generation nitinol stent for femoro-popliteal artery lesions - a single-center outcome analysis of a subcohort of MISAGO 2 study

VASA ◽  
2013 ◽  
Vol 42 (5) ◽  
pp. 340-349 ◽  
Author(s):  
Ivan Kralj ◽  
Irene Boos ◽  
Uwe Müller-Bühl

Background: Advances in stent technology have widened the field of indications for stent treatment of femoro-popliteal artery lesions, however the use of stents in bending arterial segments is restricted because some first- and second-generation nitinol stent designs did not respond well to the mechanical forces of femoro-popliteal segments in motion which pose a substantial risk of stent fracture inducing in-stent-stenosis. New generation nitinol stents are supposed to overcome these limitations but long-term results are rare. Patients and methods: In forty-five patients (mean age 68 y, range 50 - 85) with peripheral arterial disease (TASC II A-C, Rutherford category 2 - 5) forty-six lesions of the superficial femoral artery (37) or popliteal artery (9) were treated [25 high-grade stenoses, mean length 53 mm (range 30 - 145 mm); 21 chronic total occlusions, mean length 74 mm (range 30 - 180 mm)]. 74 % of lesions were located in the mobile bending arterial segments in the distal femoral or the popliteal segment. Clinical reevaluation performed at discharge, at 6, 12, 24, and 36 months included at least the measurement of ankle-brachial index (ABI) and duplex sonography. Results: Procedural success rate was 100 %. At 6, 12, 24, and 36 months, cumulative primary patency rate was 93.5 %, 84.8 %, 80.5 %, and 74.3 % (SE<10); freedom from target lesion revascularization rate was 95.7 %, 89.2 %, 84.9 %, and 79.3 % (SE<10); Rutherford category and ABI improved in all patients and clinical success was maintained in more than 85 % of patients. Conclusions: Sustained technical and clinical success and good clinical long-term results were achieved with Misago™ nitinol stent implantation in femoro-popliteal lesions with moderate risk for in-stent-stenosis, and in the distal femoral and popliteal mobile segment.

2009 ◽  
Vol 73 (11) ◽  
pp. 2143-2147 ◽  
Author(s):  
Osamu Iida ◽  
Shinsuke Nanto ◽  
Masaaki Uematsu ◽  
Kuniyasu Ikeoka ◽  
Shin Okamoto ◽  
...  

VASA ◽  
2012 ◽  
Vol 41 (6) ◽  
pp. 458-462 ◽  
Author(s):  
Vogel ◽  
Strothmeyer ◽  
Cebola ◽  
A. Katus ◽  
Blessing

We demonstrate feasibility of implantation of a self-expanding interwoven nitinol stent in a claudicant, where recanalization attempt of a heavily calcified, occluded superficial femoral artery (TASC D lesion) was complicated by a previously implanted, fractured standard stent. Wire passage through the occlusion and beyond the fractured stent could only be achieved through the subintimal space. A dedicated reentry device was used to allow distal wire entry into the true lumen at the level of the popliteal artery. Despite crushing of the fractured stent with a series of increasingly sized standard balloons, a significant recoil remainded in the area of the crushed stent. To secure patency of the femoro-popliteal artery we therefore decided to implant the novel self-expanding interwoven nitinol stent (Supera Veritas (TM), IDEV), whose unique feature is an exceptional high radial strength. Patient presented asymptomatic without any impairment of his walking capacity at three month follow up and duplex ultrasound confirmed patency of the stent. Subintimal recanalizations can be complicated by previously implanted stents, in particular in the presence of stent fracture, where intraluminal wire passage often can not be achieved. Considering the high radial strength and fracture resistance, interwoven nitinol stents represent a good treatment option in those challenging cases and they can be used to crush standard nitinol and ballonexpandable stents.


1996 ◽  
Vol 3 (4) ◽  
pp. 369-379 ◽  
Author(s):  
Michel Henry ◽  
Max Amor ◽  
Rafael Beyar ◽  
Isabelle Henry ◽  
Jean-Marc Porte ◽  
...  

Purpose: To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries. Methods: Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% ± 9.9% (range 75% to 100%), and mean lesion length was 45 ± 23 mm (range 20 to 120 mm). Results: Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%). Conclusions: This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.


2006 ◽  
Vol 32 (6) ◽  
pp. 634-638 ◽  
Author(s):  
R.H.J. Kropman ◽  
M. Bemelman ◽  
J.A. Vos ◽  
J.C. van den Berg ◽  
H.D.W.M. van de Pavoordt ◽  
...  

Author(s):  
Dominik Kaczmarek ◽  
Jacob Nattermann ◽  
Christian Strassburg ◽  
Tobias Weismüller

Abstracts Introduction Pancreatic fluid collection (PFC) is a common complication of acute pancreatitis. Endoscopic ultrasound (EUS)-guided drainage, which is often followed by direct endoscopic necrosectomy (DEN), has become the primary approach to treat PFC, including pancreatic pseudocysts (PP) and walled-off necrosis (WON). We aimed to determine retrospectively the short- and long-term results of patients treated in our endoscopy unit and to identify parameters that are associated with treatment efficacy and outcome. Methods The data of 41 consecutive patients with post-pancreatitic PFC, who underwent endoscopic transmural intervention between 2014 and 2016, were analyzed retrospectively. After an initial EUS-guided puncture, one or more plastic stents were placed and DEN was performed if necrotic tissue remained. Results The mean diameter of the PFC was 74.0 ± 4.8 mm. Of the PFCs, 29.3% were classified as PP and 70.7% as WON. Altogether, 196 transmural endoscopic procedures were performed, including 73 endoscopic necrosectomies in a subgroup of 21 patients (20 WON, 1 PP). Initial technical success was achieved in 97.6% of patients and the short-term clinical success rate was 90.2%. The long-term clinical success rate was 82.9%, since four patients died from septic shock and/or multiple organ failure and three patients developed recurrent PFC some months after the initial discharge from endoscopic treatment. Procedural complications were registered in 9 patients during 10 of 196 endoscopic procedures (5.1%): bleeding (6), cardiorespiratory insufficiency (2), perforation with pneumoperitoneum (1), aspiration with respiratory insufficiency (1), and non-perforating superficial damage of the gastric wall (1). Neither the size of the PFC nor the initial value of C-reactive protein (CRP) or other biochemical markers were correlated with efficacy or outcome of treatment. Only the cumulative number of days with CRP > 50 mg/L significantly correlated with the number of follow-up endoscopic sessions and DEN. Fungal colonization of PFC correlated significantly (p < 0.05) with the risk of mortality (44% vs. 0%), need for intensive care treatment (66.7% vs. 25%), and sepsis (55.6% vs. 12.5%). Conclusions We confirm that EUS-guided drainage followed by DEN in patients with solid necrotic material is an effective and relatively safe therapeutic approach. Prolonged elevation of CRP and fungal colonisation of the PFC are associated with a worse course of the disease.


VASA ◽  
2001 ◽  
Vol 30 (3) ◽  
pp. 212-218
Author(s):  
Robert A. Bucek ◽  
G. Schnürer ◽  
M. Haumer ◽  
M. Reiter ◽  
A. Ahmadi ◽  
...  

Background: Long term results of systemic lysis therapy with ultrahigh-dose urokinase (UHUK) in reopening aorto-iliac occlusive disease have not yet been evaluated. This prospective trial investigates the long-term primary patency rate, the rate of complications and assesses the role of different expected influence parameters on the primary patency rate. Patients and methods: 72 patients with aorto-iliac occlusive disease received daily intravenous infusions of UHUK either until reperfusion or – after at least 3 cycles – no progress in recanalization could be stated on two consecutive days by duplex scanning. Results: Systemic lysis therapy was morphological at least partially successful in 44 patients (61.1%). Concomitant percutaneous transluminal angioplasty was performed in 41 patients (56.9%), surgery in 7 patients (9.7%) and both in further 5 patients (6.9%). In patients without surgery hemodynamical success could be achieved in 39 patients (54.2%) and even more important clinical success in 51 patients (70.8%). Compared to baseline results patients improved significantly in ankle/brachial pressure index and in Fontaine stages (p < 0,001), the same results could be seen after a mean follow-up period of 62 months. Thrombolysis was complicated in 4 patients (5.6%) by macroembolizations but no major bleedings or deaths occurred. Primary patency was 76%, 64%, and 43% after 1, 5 and 10 years. Male sex and distal localization were significantly correlated with lower primary clinical patency. Conclusion: Systemic lysis therapy is an alternative to surgical intervention in acute and subacute aorto-iliac occlusive disease, because it offers acceptable long-term results with a low rate of complications.


2016 ◽  
Vol 103 (5-6) ◽  
pp. 315-322
Author(s):  
Kimihiro Igari ◽  
Toshifumi Kudo ◽  
Takahiro Toyofuku ◽  
Takehisa Iwai ◽  
Yoshinori Inoue

The aim of this study was to evaluate the long-term outcomes of the surgical repair of popliteal artery aneurysms (PAAs), and to analyze the factors associated with graft patency. Between January 1980 and December 2013, 45 limbs were subjected to open surgical repair at Tokyo Medical and Dental Hospital. We retrospectively examined the patients' clinical characteristics, clinical symptoms, and aneurysm-related anatomy. Surgical procedures were performed through a posterior or medial approach using autologous vein or prosthetic graft. Surgical outcomes were evaluated by postoperative mortality, postoperative morbidity, graft patency, and limb salvage. During the study period, 45 limbs (35 patients; mean age, 60 years) underwent open surgical repair. A total of 25 limbs were treated through a posterior approach using 23 autologous vein grafts (AVGs) and 2 expanded polytetrafluoroethylene (ePTFE) grafts. The other 20 limbs were treated through a medial approach using 13 AVGs and 7 ePTFE grafts. During the mean follow-up period of 65 months, the primary patency rates at 1, 3, and 5 years were 88.0%, 75.7%, and 75.7%, respectively, and the limb salvage rates at 1, 3, and 5 years were 97.1%, 91.4%, and 91.4%, respectively. In the univariate analysis, the ligation and bypass grafting affected the primary patency rate significantly, and the ePTFE graft was associated with a poor primary patency in the multivariate analysis (hazard ratio, 17.8). The use of resection or endoaneurysmorrhaphy for PAAs and graft interposition with an AVG might be more effective for the open repair of PAAs.


Angiology ◽  
2008 ◽  
Vol 60 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Johannes Ruef

For treatment of complex superficial femoral artery lesions, suitable stent devices are required. The present study details the first long-term results with the long EverFlex nitinol stent. Forty-one EverFlex stents were implanted in 32 patients with either superficial femoral artery occlusions (n = 20) or stenoses (n = 12); mean lesion length was 13.3 cm (range = 8.0–39.0). Patients presented with clinical stage Fontaine IIb (n = 27), III (n = 4), or IV (n = 1). Stent lengths were 10 cm (n = 18), 12 cm (n = 6), or 15 cm (n = 17). Follow-up after 2 months indicated primary and secondary patency rates of 96.9% (n = 31) and 100% (n = 32); ABI improved from 0.57 to 0.91 ( P < .001). After 1 year, revascularization was performed in 6 patients (18.8%). Primary and secondary patency rates were 81.3% (n = 26) and 93.8% (n = 30). In this first long-term evaluation, the long EverFlex nitinol stent achieves excellent clinical results after implantation into complex superficial femoral artery lesions.


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