Percutaneous Lower-extremity Arterial Interventions with Primary Balloon Angioplasty Versus SilverHawk Atherectomy and Adjunctive Balloon Angioplasty: Randomized Trial

Shammas, Nicolas W.; Coiner, Denise; Shammas, Gail A.; Dippel, Eric J.; Christensen, Lori; Jerin, Michael

doi:10.1016/j.jvir.2011.05.013

Cited by 102 publications

(87 citation statements)

References 14 publications

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“…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…”

Section: Mechanical Factorsmentioning

confidence: 99%

“…Also, directional atherectomy did not reduce TLR rates significantly in treating de novo FP segments compared with PTA, but had a significant impact on reducing bailout stent rates. 6 Randomized data comparing the excimer laser versus PTA in the FP segments are still lacking. Observational data indicate a continued high rate of restenosis with the excimer laser with low patency rate.…”

Section: Biological Factorsmentioning

confidence: 99%

“…16,17 The main benefit of altering compliance appears to be in less dissection and bailout stenting. In the Calcium 360 trial 7 and the PTA versus atherectomy plus adjunctive PTA study, 6 TLR was not statistically reduced despite less dissection and stenting although TLR rate trended less in the debulking arm. The reduced need for stenting has distinct advantages.…”

mentioning

confidence: 95%

“…9 In a randomized trial of directional atherectomy with adjunctive PTA versus PTA alone in FP segments, less dissection and bailout stenting were noted in the atherectomy arm. 6 In both arms, lesions were de novo and had the same degree of calcification and severity. Vessel diameters in both arms were also the same.…”

mentioning

confidence: 99%

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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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Section: Mechanical Factorsmentioning

confidence: 99%

Section: Biological Factorsmentioning

confidence: 99%

mentioning

confidence: 95%

mentioning

confidence: 99%

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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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“…Based on a systematic literature review of clinical measures 17 , 12 publications including registries and clinical trials were used to estimate the TLR rates associated with each endovascular procedure studied [19][20][21][22][23][24][25][26][27][28][29]. More detailed information about TLR probabilities indicated in each study is shown in Table 3.…”

Section: Resultsmentioning

confidence: 99%

An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease

Micari

Vadalà

Corbo

et al. 2015

ICFJ

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Background: Drug-coated balloons (DCBs) are an alternative for patients with peripheral arterial disease. Costs and re-intervention rates are potentially reduced compared to other technologies. We assessed the economic impact of these endovascular therapies.Methods: An Italian National Healthcare Service-perspective budget impact model with a 5-year horizon was developed to compare relative costs of 4 index procedures (plain old balloon angioplasty (POBA), DCBs, and bare-metal and drug-eluting stents (BMSs, DESs)) based on 1-year repeat-procedure rates (target-lesion revascularization (TLR)). A published systematic review of TLR rates in patients with femoral-popliteal disease undergoing these treatments was used to measure effectiveness. Costs associated with each treatment were derived from diagnosis-related group tariffs. A decision analytic model was developed to estimate 1-year costs for index procedures and possible revascularizations. Results: Pooled TLR rates show clear patient benefits for DCBs (6.9%) compared with POBA (21.6%) and BMSs (14.2%) and non-inferiority vs. DESs (7.3%). One-year payments for index and repeat interventions (by TLR rate) showed that DCBs were the least costly strategy, saving ~€1,000/patient vs. POBA. The potential savings were €8.7M, assuming 5% annual increase in DCB adoption over 5 years. Conclusions: Despite initial higher investment, DCB represent a cost-saving alternative to other technologies.

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Atherectomy for peripheral arterial disease

Ambler

Radwan

Hayes

et al. 2014

Cochrane Database of Systematic Reviews

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Percutaneous Lower-extremity Arterial Interventions with Primary Balloon Angioplasty Versus SilverHawk Atherectomy and Adjunctive Balloon Angioplasty: Randomized Trial

Cited by 102 publications

References 14 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

An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease

Atherectomy for peripheral arterial disease

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