Comparison of Orbital Atherectomy Plus Balloon Angioplasty vs. Balloon Angioplasty Alone in Patients With Critical Limb Ischemia: Results of the CALCIUM 360 Randomized Pilot Trial

Shammas, Nicolas W.; Lam, Russell C.; Mustapha, Jihad; Ellichman, Jonathan; Aggarwala, Gaurav; Rivera, Ernesto; Niazi, Khusrow; Balar, Nilesh

doi:10.1583/jevt-12-3815mr.1

Cited by 152 publications

(142 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%

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%

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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“…Technical success and patency rates are reported to be lower in case of very calcified arteries [1,[5][6][7].…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, it increases the occurrence of flow limiting dissections after PTA [8] and acute vessel recoil, with consequent increased use of stents. Also, in this condition calcium persists in playing an unfavourable role by increasing the risk of stent subexpansion, malposition, and fractures as shown in the coronary environment [5][6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

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Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Fanelli

Cannavale

Gazzetti

et al. 2014

Cardiovasc Intervent Radiol

300

223

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Purpose This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. Methods Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis [ 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0°to 360°) and to its length (length \ or [ 3 cm) evaluated with digitalsubtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium.Results Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium ([270°vs. \90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. Conclusions Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360°calcium presence.

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“…This percutaneous, minimally invasive endovascular device system is composed of a single-use, low-profile catheter with a diamond-coated crown that orbits at high speeds while removing a thin layer of calcific plaque with each pass of the crown [8]. Randomized clinical trial (RCT) evidence indicated that CLI patients receiving BA plus atherectomy involving OAS had a lower rate of complications [9][10][11][12], and medial damage [8], and reduced need for bailout stenting [12], thus preserving future treatment options.…”

Section: Figure 1 Economic Model Scaffoldmentioning

confidence: 99%

Hospital cost impact of orbital atherectomy with angioplasty for critical limb ischemia treatment: a modeling approach

et al. 2018

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Aim:The incremental cost of peripheral orbital atherectomy system (OAS) plus balloon angioplasty (BA) versus BA-only for critical limb ischemia was estimated. Materials & methods: A deterministic simulation model used clinical and healthcare utilization data from the CALCIUM 360• trial and current cost data. Incremental cost of OAS + BA versus BA-only included differential utilization during the procedure and adverse-event costs at 3, 6 and 12-months. Results: For every 100 procedures, incremental annual costs to the hospital were US$350,930 lower with OAS + BA compared with BA-only. Despite higher upfront costs, savings were realized due to reduced need for revascularization, amputation and end-of-life care over 6-12-month postoperative period. Conclusion: Atherectomy with OAS prior to BA was associated with cost savings to the hospital. Critical limb ischemia (CLI) is the most serious manifestation of peripheral artery disease (PAD). Considered as the 'end stage' of PAD, it involves a chronic lack of blood supply leading to persistent ischemic rest pain in the feet or toes, nonhealing wounds and ulcers, and gangrene [1]. CLI often results in amputation of the affected limb(s) with roughly 25% of CLI patients receiving at least one lower extremity amputation [2]. The economic burden of CLI-diagnosed Medicare patients exceeds US$3.1 billion annually, with most of this cost reflecting the high incidence of hospitalizations related to limb loss and the need for major amputation [3].Treating CLI patients has remained quite challenging, since the associated calcification requires a unique mechanism of action to treat the lesion without damaging the vessel [4]. Balloon angioplasty (BA) continues to be the first-line of revascularization strategy in patients where procedural success via less invasive, nonsurgical approach is favored despite consistently poor intermediate and long-term patency outcomes [5,6]. The latter has been attributed to the presence of calcified plaque in femoropopliteal lesions, with arterial wall calcium associated with higher rates of procedural complications, and flow-limiting dissections that frequently require stent deployment in order to maintain vessel patency [4][5][6]. Furthermore, restenosis rates as high as 40-60% within 1 year of postprocedure and poor correlation between primary patency and limb preservation have been reported. But the American College of Cardiology/American Heart Association guidelines currently recommend against primary stenting of femoropopliteal lesions with atherectomy and stent devices indicated for 'bailout' purposes following suboptimal BA results [5]. Stenting in calcified segments after a prior failed BA often results in stent under expansion and malapposition [6,7]. These are recognized predictors of long-term stent patency and indicate an increased risk of

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Comparison of Orbital Atherectomy Plus Balloon Angioplasty vs. Balloon Angioplasty Alone in Patients With Critical Limb Ischemia: Results of the CALCIUM 360 Randomized Pilot Trial

Cited by 152 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

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

Hospital cost impact of orbital atherectomy with angioplasty for critical limb ischemia treatment: a modeling approach

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