Excimer Laser Recanalization of Femoropopliteal Lesions and 1-Year Patency: Results of the CELLO Registry

Davé, Rajesh; Patlola, Raghotham; Kollmeyer, Kenneth R.; Bunch, Frank; Weinstock, Barry S.; Dippel, Eric J.; Jaff, Michael R.; Popma, Jeffrey J.; Weissman, Neil J.

doi:10.1583/09-2781.1

Cited by 79 publications

(42 citation statements)

References 13 publications

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“…Observational data, however, noted a variable rate of stenting in the FP segment after excimer laser ranging from 23 to 50%, but these studies were not designed specifically to evaluate bailout stenting following laser treatment. [10][11][12] Altering vessel compliance may also be achieved by plaque modification without debulking of the lesion. For instance, cutting balloon (CB) atherotomes improve vessel compliance by scoring through a lesion, and therefore allowing better dilation of the vessel at lower balloon pressure.…”

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confidence: 99%

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

Shammas¹

2013

Int J Angiol

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ReviewPeripheral arterial disease is highly prevalent in the general population affecting 12 to 14% of people and leading to claudication or threatened limb ischemia. 1 Endovascular lower extremity arterial interventions have increased exponentially over the past decade. 2 The femoropopliteal (FP) segment represents 40% of vessels treated and its treatment continues to be a challenge to the endovascular specialist. Despite a high rate of acute procedural success, target lesion revascularization (TLR) and target vessel revascularization remain elevated. 3,4 We have previously proposed a triad of optimal peripheral vascular revascularization strategy (►Fig. 1) 5 with an emphasis on three key principles: (1) Mechanical, improve vessel compliance to allow dilatation of a stenotic segment at low balloon inflation pressure and reduce dissection and recoil. Low balloon inflation pressure would theoretically preserve vessel integrity by minimizing barotrauma and bailout stenting. (2) Biological, inhibit smooth muscle cell (SMC) proliferation to improve patency rates and reduce repeat revascularization. (3) Procedural, preserve the outflow vessels by minimizing distal embolization (DE) and reduce procedural time and radiation exposure to both operator and patient.In this overview, we examine these principles to determine whether current data support their validity. We recognize the lack of uniform performance criteria and reporting standards in clinical trials in peripheral arterial disease. This unfortunately makes comparisons across studies difficult. Mechanical FactorsThe concept of improving vessel compliance as a prerequisite to a more definitive treatment of the FP artery has gained more attention over the past few years. Measurement of vessel compliance in vivo is difficult to obtain. One surrogate endpoint is the minimum balloon pressure (MBP) needed to fully stretch the artery to a lumen diameter equal to a normal reference segment with the use of a noncompliant balloon sized 1:1 to the reference vessel. The balloon is typically inflated to two atmospheres then the inflation pressure is increased by increment of one atmosphere at a time until full balloon expansion is achieved. 6,7 According to Laplace's law, tension (T) in the vessel wall is equal to (pressure (P) gradient across the arterial wall * radius (R) of artery)/wall thickening (M), or (T¼ [P * R]/M). In order for MBP change to reflect on compliance, the segments under comparison need to have similar radius and lesion Keywords AbstractTreatment of the femoropopliteal (FP) artery remains a challenge to the endovascular specialist. Long-term patency is low with a high rate of target lesion revascularization. The true patency rate varies considerably between studies partly because there is a lack of uniform performance criteria and reporting standards in peripheral arterial interventions. Literature review supports three principles that emerge as important components of an optimal strategy in treating the FP artery: (1) improving vessel compliance and sub...

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confidence: 99%

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

Shammas¹

2013

Int J Angiol

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“…Although the CELLO study has used the Turbo-Booster laser guide catheter to increase lumen diameter and maximize plaque removal, the PP rate was 59% at 6 months and 54% at 1 year. TLR was required in 23.1% of CELLO participants at 1 year [16]. However, the mean lesion length in this study was relatively short (5.6 ± 4.7 cm).…”

Section: Discussionmentioning

confidence: 89%

Comparison of Immediate and 2-Year Outcomes between Excimer Laser-Assisted Angioplasty with Spot Stent and Primary Stenting in Intermediate to Long Femoropopliteal Disease

Chou

Chang

et al. 2013

The Scientific World Journal

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Background. To compare the clinical outcomes between excimer laser-assisted angioplasty (ELA) with spot stent (group A) and primary stenting (group B) in intermediate to long femoropopliteal disease. Methods. Outcomes of 105 patients totaling 119 legs treated with two different strategies were analyzed retrospectively in a prospectively maintained database. Results. Baseline characteristics were similar in both groups. Better angiographic results and lesser increase of serum C-reactive protein levels (0.60 ± 0.72 versus 2.98 ± 0.97 mg/dL, P < 0.001) after the intervention were obtained in Group B. Group A had inferior 1-year outcomes due to higher rate of binary restenosis (67% versus 32%, P = 0.001) and lower rate of primary patency (40% versus 58%, P = 0.039). Rates of amputation-free survival, target vessel revascularization, assisted primary patency, and stent fracture at 24 months were similar in both groups (80% versus 82%, P = 0.979, 65% versus 45%, P = 0.11, 78% versus 80%, P = 0.75 and 6.3% versus 6.8%, P = 0.71, resp.). Conclusion. Greater vascular inflammation after ELA with spot stent resulted in earlier restenosis and inferior 1-year clinical outcomes than primary stenting. This benefit was lost in the primary stenting group at 2 years due to late catch-up restenosis. Active surveillance with prompt intervention was required to maintain the vessel patency.

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“…Clinical trials of excimer laser have shown feasibility in treatment of both peripheral and coronary artery disease [15][16][17][18] .…”

Section: Discussionmentioning

confidence: 99%

<b>Effects of Excimer Laser on Vascular Prosthetic Materials: A Preliminary Study for the Laser Treatment of Prosthetic Graft Failur</b><b>e </b>

Tsuchida

Papaioannou²,

Grundfest

et al. 2013

JJSLSM

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Excimer Laser Recanalization of Femoropopliteal Lesions and 1-Year Patency: Results of the CELLO Registry

Abstract: The data validate the safety and efficacy of the investigational device, with a high clinical success rate and 12-month data indicating freedom from reintervention in the majority of patients treated.

Cited by 79 publications

References 13 publications

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

Comparison of Immediate and 2-Year Outcomes between Excimer Laser-Assisted Angioplasty with Spot Stent and Primary Stenting in Intermediate to Long Femoropopliteal Disease

<b>Effects of Excimer Laser on Vascular Prosthetic Materials: A Preliminary Study for the Laser Treatment of Prosthetic Graft Failur</b><b>e </b>

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