Superficial femoral artery TASC D Registry: twelve-month effectiveness analysis of the Pulsar-18 SE nitinol stent in patients with critical limb ischemia.

Abstract

AIM:

Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI).

METHODS:

Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR<2.5) and respectively no target lesion revascularization performed within 12 months. The average lesion length of the treated femoro-popliteal segment was 315 mm. Performing spot stenting average stent length in all patients was 245 mm (minimal 215 mm, maximal 315 mm).

RESULTS:

Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%.

CONCLUSION:

Endovascular intervention of long SFA occlusions using subintimal or intraluminal recanalization technique with implantation of the Pulsar-18 SE nitinol stent in CLI patients is safe and clinically effective with a primary patency rate after 12 months of 77% and a freedom from target lesion revascularization rate of 86%.

• Authors: M Lichtenberg, W Stahlhoff, D Boese
• Journal: The Journal of cardiovascular surgery (J Cardiovasc Surg (Torino)) Vol. 54 Issue 4 Pg. 433-9 (Aug 2013) ISSN: 1827-191X [Electronic] Italy
• PMID: 24013531 (Publication Type: Journal Article)

Chemical References

• Alloys
• nitinol

Topics

• Aged
• Alloys
• Amputation, Surgical
• Angioplasty, Balloon (adverse effects, instrumentation)
• Chronic Disease
• Constriction, Pathologic
• Critical Illness
• Exercise Test
• Exercise Tolerance
• Female
• Femoral Artery (diagnostic imaging, physiopathology)
• Germany
• Humans
• Ischemia (diagnosis, physiopathology, therapy)
• Kaplan-Meier Estimate
• Limb Salvage
• Lower Extremity (blood supply)
• Male
• Peripheral Arterial Disease (diagnosis, physiopathology, therapy)
• Predictive Value of Tests
• Prosthesis Design
• Recovery of Function
• Registries
• Stents
• Time Factors
• Treatment Outcome
• Ultrasonography, Doppler, Duplex
• Vascular Patency
• Wound Healing