Abstract
Background
Long-term patency rates for percutaneous peripheral arterial interventions are suboptimal. Optical coherence tomography (OCT) guided atherectomy may yield superior patency by optimizing plaque removal while preserving the tunica media and adventitia.
Methods
The VISION study is a multicenter prospective study of patients with peripheral arterial disease undergoing OCT guided atherectomy with the Pantheris™ device. In 11 patients enrolled in a single center, we report procedural and clinical outcomes, at 30 days and 6 months.
Results
The mean age was 63 ± 11 years and 73% (n = 8) were men. The target lesion was in the superficial femoral artery in 82% (n = 9) of the patients. Mean stenosis severity was 87% ± 10% and mean lesion length was 39 ± 31 mm. Procedural success was observed in all patients with no device related complications. Mean post-atherectomy stenosis was 18% ± 15%. Almost all excised tissue consisted of intimal plaque (94%). At 30 days, significant improvements in Rutherford class, VascuQoL scores and ABI were observed, 0.9 ± 0.8 vs. 3.1 ± 0.7 (p = 0.01), 4.9 ± 1.9 vs. 3.6 ± 1.5 (p = 0.03) and 1.04 ± 0.19 vs. 0.80 ± 0.19 (p < 0.01) respectively. At 6 months, there were significant improvements in Rutherford class (1.0 ± 1.0 vs. 3.1 ± 0.7, p = 0.01) and ABI (0.93 ± 0.19 versus 0.80 ± 0.19, p = 0.02) but not in VascuQoL scores (3.7 ± 1.4 versus 3.6 ± 1.5, p = 0.48). Target lesion revascularization occurred in 18% (n = 2) of the patients.
Conclusion
OCT guided atherectomy resulted in high procedural success, no device related complications and encouraging results up to 6 months. Histological analysis suggested little injury to the media and adventitia. Larger studies are needed to confirm the efficacy of this approach.
Highlights
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OCT- guided atherectomy may yield superior patency by optimizing plaque removal and preserving the tunica media and adventitia.
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OCT guided atherectomy resulted in high procedural success, no device related complications and encouraging clinical results up to 6 months.
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Histological analysis of the initial single-center experience of the VISION study suggested little injury to the media and adventitia
1
Introduction
Peripheral arterial disease (PAD) affects >200 million people worldwide and is associated with significant morbidity and mortality . Despite significant advances in surgical and percutaneous techniques, long-term patency rates remain suboptimal . Directional atherectomy is widely used to improve procedural success rates and outcomes. Although a variety of atherectomy devices are currently available, randomized controlled trials to compare their safety and effectiveness are lacking . With most available devices, atherectomy is performed based on conventional angiography, risking injury to healthy segments of the vessel wall, the tunica media and adventitia. This unwarranted injury is associated with higher rates of restenosis .
Optical coherence tomography (OCT), a high resolution intravascular imaging tool widely used in coronary arteries, has recently been applied in peripheral interventions . The Pantheris™ System (Avinger, Redwood City, CA, USA) uses OCT to guide the atheretocmy procedure and may result in higher vessel patency by targeting sectors with larger plaque burden and preserving the tunica media.
The Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature (VISION) trial is a non-randomized, multicenter study designed to assess the efficacy and safety of the Pantheris™ device. In this paper, we report immediate, 30 days and 6 months results of 11 patients from a single center undergoing atherectomy with the Pantheris™ device as part of the VISION study.
2
Methods
The VISION trial is a non-randomized, prospective, multicenter clinical study designed to evaluate the safety and efficacy of the Patheris™ System (Avinger, Redwood City, CA, USA) in the treatment of obstructive PAD. The Pantheris™ System is an atherectomy device which uses OCT imaging as an adjunct to fluoroscopy to guide the percutaneous excision of atherosclerotic plaque ( Fig. 1 ). This report focuses on the initial experience of a single participating center.
The study was approved by the institutional review board of our institution and informed consent was obtained from all participating patients. Arkansas Heart Hospital and Arkansas Heart Hospital Clinic were approved by the Western Institutional Review Board (WIRB approval No. 20,131,260) and this study was performed in compliance with the Declaration of Helsinki. The VISON trial is registered at clinicaltrials.gov ( NCT01937351 ).
2.1
Study population
Adult patients with symptomatic peripheral arterial disease (Rutherford Classes 2 through 5) referred for percutaneous intervention were eligible if they met the following criteria: 1) de novo lesion distal to the profunda femoral artery bifurcation with stenosis >70%, 2) reference lumen of the target lesion between 2.5 mm and 7.0 mm, 3) target lesion length ≤ 15 cm and 4) at least one tibial run-off vessel. Exclusion criteria included moderate to severe calcification of the target lesion, acute ischemia or thrombosis of the superficial femoral or popliteal arteries, in-stent restenosis within the target lesion, significant (>70%) stenosis proximal to the target lesion not successfully treated during the index procedure, endovascular or surgical revascularization procedure in the target limb within 30 days, intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within 2 months, creatinine level > 2.0 mg/dL and any clinical or angiographic complication attributed to another device prior to insertion of the study device.
2.2
Intervention
Angiography was performed according to current practice standards. Once eligibility was confirmed based on lesion characteristics, an 8 French occluder sheath was placed in the contralateral femoral artery. After crossing the target lesion, a filter based embolic protection device was placed distal to the diseased segment. The occluder balloon in the sheath was then inflated and dextrose was injected to allow OCT based visualization of the lesion. The Pantheris™ device was then advanced over a 0.014″ guide wire and OCT guided atherectomy was performed until the operator was satisfied with the result. Angiography was then repeated and post-atherectomy residual stenosis was assessed. Subsequent balloon angioplasty and stenting were performed at the discretion of the operator. A final angiogram was performed and post procedure residual stenosis was assessed.
2.3
Clinical follow up and outcome assessment
Patients underwent measurement of the ankle–brachial index (ABI) as well as symptom assessment according to the Rutherford Classification and the Vascular Quality of Life (VascuQoL) questionnaire at baseline, 30 days and 6 months .
The primary safety endpoint was defined as freedom from major adverse events through 6 months. The composite of major adverse events included: cardiovascular related death, unplanned major index limb amputation, clinically driven target lesion revascularization (TLR), myocardial infarction and device related events defined as clinically significant perforation, dissection, embolization or target site pseudoaneurysm. For this report, events were adjudicated by two board certified cardiologists. The primary efficacy endpoint was technical success which was defined as residual post atherectomy stenosis diameter < 50%. For this report, angiographic results were adjudicated by two board certified interventional cardiologists.
All tissue recovered from the Pantheris atherectomy was fixed in formalin and sent for core lab adjudicated histologic analysis. Total tissue specimen weight was recorded. Additionally, surface area of the following components were calculated for percent contribution calculations: intimal resection (resection of atherosclerotic plaque without medial and adventitial components); medial resection (presence of media with or without intimal tissue, but no adventitial component); adventitial resection (full thickness resection with intimal, medial, and adventitial elements present); total tissue area (intimal resection + medial resection + adventitial resection); and % area of adventitial tissue and EEL (adventitia tissue and EEL area/total tissue area).
2.4
Statistical analysis
Categorical variables are reported as numbers and percentages. Continuous variables are reported as mean ± standard deviation. Serial Rutherford class, VascuQoL scores and ABI were compared using the Wilcoxon matched-pairs signed-rank test. Separate p-values are reported for 30 days versus baseline and 6 months versus baseline. Analysis was performed with Stata 13.1 (StataCorp LP, College Station, TX, USA).
2
Methods
The VISION trial is a non-randomized, prospective, multicenter clinical study designed to evaluate the safety and efficacy of the Patheris™ System (Avinger, Redwood City, CA, USA) in the treatment of obstructive PAD. The Pantheris™ System is an atherectomy device which uses OCT imaging as an adjunct to fluoroscopy to guide the percutaneous excision of atherosclerotic plaque ( Fig. 1 ). This report focuses on the initial experience of a single participating center.
The study was approved by the institutional review board of our institution and informed consent was obtained from all participating patients. Arkansas Heart Hospital and Arkansas Heart Hospital Clinic were approved by the Western Institutional Review Board (WIRB approval No. 20,131,260) and this study was performed in compliance with the Declaration of Helsinki. The VISON trial is registered at clinicaltrials.gov ( NCT01937351 ).
2.1
Study population
Adult patients with symptomatic peripheral arterial disease (Rutherford Classes 2 through 5) referred for percutaneous intervention were eligible if they met the following criteria: 1) de novo lesion distal to the profunda femoral artery bifurcation with stenosis >70%, 2) reference lumen of the target lesion between 2.5 mm and 7.0 mm, 3) target lesion length ≤ 15 cm and 4) at least one tibial run-off vessel. Exclusion criteria included moderate to severe calcification of the target lesion, acute ischemia or thrombosis of the superficial femoral or popliteal arteries, in-stent restenosis within the target lesion, significant (>70%) stenosis proximal to the target lesion not successfully treated during the index procedure, endovascular or surgical revascularization procedure in the target limb within 30 days, intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within 2 months, creatinine level > 2.0 mg/dL and any clinical or angiographic complication attributed to another device prior to insertion of the study device.
2.2
Intervention
Angiography was performed according to current practice standards. Once eligibility was confirmed based on lesion characteristics, an 8 French occluder sheath was placed in the contralateral femoral artery. After crossing the target lesion, a filter based embolic protection device was placed distal to the diseased segment. The occluder balloon in the sheath was then inflated and dextrose was injected to allow OCT based visualization of the lesion. The Pantheris™ device was then advanced over a 0.014″ guide wire and OCT guided atherectomy was performed until the operator was satisfied with the result. Angiography was then repeated and post-atherectomy residual stenosis was assessed. Subsequent balloon angioplasty and stenting were performed at the discretion of the operator. A final angiogram was performed and post procedure residual stenosis was assessed.
2.3
Clinical follow up and outcome assessment
Patients underwent measurement of the ankle–brachial index (ABI) as well as symptom assessment according to the Rutherford Classification and the Vascular Quality of Life (VascuQoL) questionnaire at baseline, 30 days and 6 months .
The primary safety endpoint was defined as freedom from major adverse events through 6 months. The composite of major adverse events included: cardiovascular related death, unplanned major index limb amputation, clinically driven target lesion revascularization (TLR), myocardial infarction and device related events defined as clinically significant perforation, dissection, embolization or target site pseudoaneurysm. For this report, events were adjudicated by two board certified cardiologists. The primary efficacy endpoint was technical success which was defined as residual post atherectomy stenosis diameter < 50%. For this report, angiographic results were adjudicated by two board certified interventional cardiologists.
All tissue recovered from the Pantheris atherectomy was fixed in formalin and sent for core lab adjudicated histologic analysis. Total tissue specimen weight was recorded. Additionally, surface area of the following components were calculated for percent contribution calculations: intimal resection (resection of atherosclerotic plaque without medial and adventitial components); medial resection (presence of media with or without intimal tissue, but no adventitial component); adventitial resection (full thickness resection with intimal, medial, and adventitial elements present); total tissue area (intimal resection + medial resection + adventitial resection); and % area of adventitial tissue and EEL (adventitia tissue and EEL area/total tissue area).
2.4
Statistical analysis
Categorical variables are reported as numbers and percentages. Continuous variables are reported as mean ± standard deviation. Serial Rutherford class, VascuQoL scores and ABI were compared using the Wilcoxon matched-pairs signed-rank test. Separate p-values are reported for 30 days versus baseline and 6 months versus baseline. Analysis was performed with Stata 13.1 (StataCorp LP, College Station, TX, USA).
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