iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study.

PURPOSE: To evaluate safety and effectiveness of the iCAST Covered Stent for treatment of iliac artery atherosclerotic lesions. MATERIALS AND METHODS: The iCARUS trial (ClinicalTrials.gov Identifier: NCT00593385) was a single-arm, prospective, multicenter study that enrolled 152 per protocol subjects at 25 sites in the United States and Germany. Subjects with multiple lesions and/or stents were eligible. The primary endpoint was the composite rate of death within 30 days, target lesion revascularization (TLR) within 9 months, or restenosis at 9 months after procedure. Secondary endpoints included major adverse vascular events (MAVEs), primary patency, freedom from TLR, and clinical success. RESULTS: Device and acute procedural success were achieved in 98.7% and 92.7% of cases, respectively. MAVE rate was 4.6% at 30 days. The 9-month primary composite endpoint rate was 8.1% (10/123), which was below the performance goal of 16.57%. Nine-month primary patency, defined as continuous flow without revascularization, bypass, or target limb amputation, was 96.4%. Freedom from TLR at 9 months and 3 years was 97.2% and 86.6%, respectively. Early clinical success was seen in 88.7% of subjects at 30 days with sustained clinical benefit in 72.4% of subjects at 3 years. CONCLUSIONS: The iCARUS study demonstrated that the iCAST Covered Stent was safe and effective for treatment of atherosclerotic iliac artery lesions with sustained clinical benefit out to 3 years.

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.

Carotid artery stenting and patient outcomes: the CABANA surveillance study.

OBJECTIVES: The purpose of the prospective, multicenter, nonrandomized CABANA study was to evaluate periprocedural clinical outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System by a diverse group of clinicians. BACKGROUND: There is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels. METHODS: The study enrolled symptomatic (≥50% carotid artery stenosis) and asymptomatic (≥80% carotid stenosis) patients at high risk for carotid endarterectomy. Study centers were grouped into three tiers based on previous CAS experience while individual operators were grouped by their CAS training. The primary endpoint was the 30-day composite of major adverse events [MAEs; including stroke, death, and myocardial infarction (MI)]. Individual event rates were evaluated across the overall study, and by center experience and physician training tier. RESULTS: Of 1,097 enrolled patients, 1,025 were evaluable for 30-day MAE rate. The stroke rate (3.3%) was a major contributing factor in the overall MAE rate (4.6%). Mortality was 1.3% and the MI rate was 0.5%. There was no statistically significant association between MAE rates among the center experience tiers (P = 0.61) nor among the operator training categories (P = 0.26). CONCLUSIONS: CAS with the Carotid WALLSTENT and FilterWire EZ yielded a low 30-day MAE rate that did not differ significantly across operator experience and training levels. Clinicaltrials.gov identifier: NCT00741091.

Percutaneous Coil Embolization of Coronary Artery Fistula Complicated by Refractory Ventricular Fibrillation and Cardiogenic Shock.

We present a case of a 56-year-old patient with a symptomatic right coronary artery to pulmonary artery fistula who underwent coil embolization. Post-procedure, the patient developed ventricular fibrillation that was refractory to antiarrhythmic medications and numerous attempts at defibrillation. (Level of Difficulty: Intermediate.).

Update on cardiogenic shock: The evolving landscape of a multidisciplinary and collaborative approach.

ABSTRACT: The American Heart Association scientific statement on cardiogenic shock and the National Cardiogenic Shock Initiative have provided the impetus to advance knowledge and development of national guidelines for cardiogenic shock. We evaluate the current state of knowledge surrounding cardiogenic shock and limitations to the development of national guidelines.

Case Series of Percutaneous Mechanical Aspiration of Mitral Valve Endocarditis.

Infective endocarditis of the mitral valve that is refractory to medical therapy requires surgical debridement. However, patients who are high risk for surgery have limited options. We report 3 cases of refractory infective endocarditis involving the mitral valve that were treated with percutaneous mechanical aspiration with an embolic protection system. (Level of Difficulty: Intermediate.).

The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel.

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

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.

Usefulness of optical coherent reflectometry with guided radiofrequency energy to treat chronic total occlusions in peripheral arteries (the GRIP trial).

Optical coherent reflectometry, a forward-looking, fiberoptic-guided device was used in 72 patients to direct radiofrequency energy across the central intraluminal portion of 75 chronic total occlusions in peripheral arteries (iliac, femoral, and popliteal) that failed attempts with conventional guidewires. The system was successful in crossing 76% of the chronic total occlusions with no clinical perforations or distal embolizations, and complications consisted of a single dissection greater than or equal to grade C.

Initial clinical experience using an ostial stent positioning system (Ostial Pro) for the accurate placement of stents in the treatment of coronary aorto-ostial lesions.

OBJECTIVE: To evaluate the safety and efficacy of a new nitinol stent positioning system to assist in the placement of aorto-ostial coronary stents. BACKGROUND: The stenting of aorto-ostial lesions is technically challenging. METHODS: We report the first clinical series using the Ostial Pro to assist in the precise placement of stents in coronary aorto-ostial lesions. These results were compared to matched cases performed without the ostial positioning system. RESULTS: The Ostial Pro is a simple nitinol device with self-expanding legs that are advanced just distal to the tip of the guiding catheter. The nitinol legs prevent the entry of the guiding catheter into the target vessel and align the tip of the guiding catheter. Using the Ostial Pro positioning device, angiographic and clinical success was achieved in 30/30 (100%) cases. Excellent stent positioning was confirmed by angiography (n = 30) and intravascular ultrasound (n = 28). The final true ostial dimension was larger than the stented segment minimum luminal diameter in 30/30 cases. In a matched consecutive cohort of 30 consecutive coronary aorto-ostial stent cases placed without the Ostial Pro, we observed an ostial stent malpositioning in 18/30 (60%) of cases (p < 0.0001 vs. cases performed with Ostial Pro). CONCLUSIONS: 1) The Ostial Pro is a new FDA-cleared nitinol device that is simple to use and effective in allowing the precise placement of stent(s) at the aorto-ostial location; 2) this approach appears to provide an efficient means to assure accurate stent placement and minimal residual stenosis in these difficult-to-treat lesions.