Intravascular Ultrasound Validation of Contemporary Angiographic Scores Evaluating the Severity of Calcification in Peripheral Arteries.

PURPOSE: To validate 3 angiographic scoring systems for peripheral artery calcification using intravascular ultrasound (IVUS) as the gold standard. METHODS: The study employed preprocedure angiography and IVUS data from 47 patients (median age 72 years; 34 men) in the 55-patient JetStream G3 Calcium Study ( ClinicalTrials.gov identifier NCT01273623) to validate the 3 angiographic scoring systems [Peripheral Academic Research Consortium (PARC), Peripheral Arterial Calcium Scoring System (PACSS), and the DEFINITIVE Ca++ trial]. Preprocedure angiograms were analyzed using conventional quantitative vessel analysis software in 2 orthogonal views. Calcium length was evaluated by markers placed beside the artery during the procedure; calcium deposit(s) were assessed as being on one or both sides of the vessel wall. The 3 calcium scoring systems used these 2 basic angiographic elements to evaluate calcium severity. Based on these criteria, calcium severity varied from none to focal, mild, moderate, or severe in PARC; grade 0 to 4 in PACSS; and none, moderate, or severe in the DEFINITIVE Ca++ system. Calcium location on IVUS was classified as superficial, deep, or mixed. Lesion length was the segment between the most normal looking proximal and distal reference sites. Superficial, deep, and calcium length were based on motorized IVUS pullback. RESULTS: IVUS detected calcium in 44/47 (93.6%) lesions, and angiography detected calcium in 26/47 (55.3%) lesions (p<0.001). The sensitivity, specificity, positive predictive value, and negative predictive value of angiography relative to IVUS were 59%, 100%, 100%, and 14%, respectively. With increasing severity of angiographic calcium, there was a stepwise increase in the prevalence of IVUS superficial calcium and the maximum arc and length of superficial calcium. Using PARC criteria, with increasing severity of calcification, IVUS maximum calcium arc increased from 120° for none to 305° for severe (p<0.001); the length of calcium increased from 7 to 68 mm (p<0.001). Though a similar trend was seen in IVUS superficial calcium, it was not observed in IVUS deep calcium. Similar observations were seen when using the PACSS and DEFINITIVE Ca++ scoring systems. CONCLUSION: IVUS confirmed that the PARC, PACSS, and DEFINITIVE Ca++ calcium scoring systems can be used to classify the degree of calcium in peripheral artery disease, especially superficial calcium.

Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries.

AIMS: Endovascular treatment of calcified femoral-popliteal disease is challenging. We sought to evaluate the mechanism of lumen gain when using the JETSTREAM Atherectomy System to treat calcified peripheral artery lesions. METHODS AND RESULTS: The JETSTREAM Calcium Study was a prospective, single-arm, multicentre study to evaluate the JETSTREAM Atherectomy System for severely calcified femoral-popliteal artery lesions, i.e., patients with claudication and lesions with superficial calcium >90° and >5 mm in length as determined by intravascular ultrasound (IVUS). The 2.1 mm catheter was used in this study without distal protection. Fifty-five patients underwent angiographic screening: 26 (45%) met IVUS inclusion criteria. Angiographic calcium was moderate in eight cases and severe in 14, with no available data for four cases. Visual diameter stenosis was 86±9% pre-treatment, 37±13% post atherectomy, and 10±6% post adjunctive treatment (adjunctive PTA+stenting in eight and adjunct PTA alone in 16). IVUS showed lumen area increased from 6.6±3.7 mm2 to 10.0±3.6 mm2 (p=0.001): calcium reduction was responsible for 86±23% of the lumen increase. Although the superficial calcium arc did not change (151±70° to 146±71°, p=0.83), the arc of reverberation increased (23±20° to 65±40°, p=0.006), indicating device-related modification of calcium. Adjunctive balloon angioplasty was performed in 62% of the lesions, and stent implantation in 31%. In 11 cases with adjunctive balloon dilation, the MLA increased from 7.1 (6.4, 7.8) mm2 post atherectomy to 11.9 (10.3, 13.5) mm2 post balloon (p<0.001) without flow-limiting dissection. No major adverse events occurred up to 30 days post procedure in either the study group or the patients who were excluded from the analysis. CONCLUSIONS: The JETSTREAM Atherectomy System increased lumen dimensions in moderately or severely calcified femoral-popliteal lesions by removing superficial calcium without major complications.

Contemporary endovascular treatment for disease of the superficial femoral and popliteal arteries: an integrated device-based strategy.

Endovascular therapy for disease of the superficial femoral artery (SFA) and the popliteal artery remains controversial. Percutaneous treatment of this arterial segment presents a particular technical challenge, as the extent of disease varies from short, focal, and stenotic to long, diffuse, and occluded lesions. Over the last 2 decades, multiple therapies have been evaluated, including simple balloon angioplasty, directional atherectomy, stenting (both balloon-expandable and self-expanding), and more recently, intra-arterial radiation, laser, and cryotherapy. Regardless of which modality is used, however, endovascular therapy as a revascularization strategy has the potential to improve symptoms and quality of life and, in selected patients, to avoid limb amputation. While percutaneous endovascular treatment has been historically associated with high procedural success and favorable short and intermediate-term patency rates, long-term clinical results have proven disappointing. Conventional balloon angioplasty is limited by elastic recoil, dissection, and restenosis. Balloon-expandable stents (particularly in the distal SFA) are associated with late stent deformation and mechanical compression, with resultant late clinical failure. Newer self-expanding stents have shown improved initial results but have been limited by late mechanical fatigue and associated restenosis. With the development of several newer endovascular techniques in recent years, the possibilities for treating this condition have increased dramatically. Currently, no long-term comparative data exist regarding the role of these alternative technologies. This article summarizes and compares important data about new endovascular options for intervention therapy in SFA and popliteal disease. In addition, based on this analysis, we propose a contemporary treatment strategy, integrating older and newer technologies into a real-world algorithm.

Durable clinical benefit following Sr90 Beta irradiation therapy for in-stent restenosis in high-volume community practice.

Although randomized clinical trials have demonstrated efficacy of coronary irradiation versus placebo for the treatment of in-stent restenosis (ISR), durable long-term benefit in community practice is less well defined. From January 1, 2001, through June 30, 2002, consecutive percutaneous coronary intervention (n = 3,869) were analyzed at our center with a total of 330 patients undergoing coronary irradiation for ISR (53, Ir192; 12, P32; 265 Novoste Sr90). Novoste Sr90 was successfully performed in 265 of 270 (98%) of patients attempted by 10 operators. The mean patient age was 63 years (range 35 90) with 55% male (145/265) and 45% female (120/265). ISR anatomic subsets included multi-lesion (45/265; 17%), multi-vessel (27/265; 10.0%) and saphenous vein graft (16/265; 6.0%) interventions. At a mean follow-up of 10.5 2.8 (SD) months, fifty-three (20%) of the Novoste Sr90 treated patients had returned for symptoms requiring repeat angiography. Of these, 23 patients had repeat percutaneous coronary intervention (PCI) including 2 target site revascularizations (TSR), twelve non-TSR (distinct from the radiated segment of the target vessel), and 9 non-target vessel revascularizations (TVR). Coronary artery bypass surgery was performed in 11 total patients, 4 due to TSR, and 7 due to non-TVR. Clinical TSR was 2.3% (6/265) and TVR was 6.8% (18/265). In conclusion, the Novoste SR90 Beta-Cath System for the treatment of ISR is associated with a high procedural success rate and low TSR and TVR. Revascularization in follow-up is predominantly due to progressive disease outside the radiated segment and aggressive secondary prevention, especially prolonged anti-platelet therapy, appear critical to long-term procedural success.