Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

INTRODUCTION: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. AREAS COVERED: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. EXPERT OPINION: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Comparison of Triple-Rule-Out Prospectively ECG-triggered Systolic and Diastolic Acquisition Protocol in Patients With Acute Chest Pain.

PURPOSE: The purpose of this study was to compare image quality and coronary interpretability of triple-rule-out systolic and diastolic protocols in patients with acute chest pain. MATERIALS AND METHODS: From March 2016 to October 2017 the authors prospectively enrolled patients with undifferentiated acute chest pain, who were at low to intermediate cardiovascular risk. Those with heart rate >75 bpm underwent a systolic prospectively triggered acquisition (systolic triggering [ST]), and in those with ≤75 bpm, end-diastolic triggering (DT) was instead performed. Examinations were evaluated for coronary artery disease, aortic dissection, and pulmonary embolism. Image quality was assessed using a Likert scale. Coronary arteries interpretability was evaluated both on a per-vessel and a per segment basis. The occurrence of major adverse cardiovascular events was investigated. RESULTS: The final study population was 189 patients. Fifty-two patients (27.5%) underwent systolic acquisition and 137 (72.5%) underwent diastolic acquisition. No significant differences in overall image quality were observed between DT and ST groups (median score 5 [interquartile ranges 4 to 5] vs. 4 [interquartile ranges 4 to 5], P =0.074). Although both DT and ST protocols showed low percentages of noninterpretable coronary arteries on a per-vessel (1.5% and 6.7%, respectively) and per-segment analysis (1% and 4.7%, respectively), these percentages resulted significantly higher for ST groups ( P <0.001). Obstructive coronary stenosis was observed in 18 patients. Only one case of pulmonary embolism was diagnosed and no cases of aortic dissection were found in our population. No death or major adverse cardiovascular events were observed during follow-up among the 2 groups. CONCLUSIONS: Results showed that triple-rule-out computed tomography angiography is a reliable technique in patients with acute chest pain and that an ST acquisition protocol could be considered an alternative acquisition protocol in patients with higher heart rate, reaching a good image quality.

Superior Rectal Artery Embolization for Symptomatic Grades 2 and 3 Hemorrhoidal Disease: 6-Month Follow-up among 43 Patients.

PURPOSE: To assess the technical and clinical success rates of superior rectal artery embolization in the treatment of symptomatic Grades 2 and 3 hemorrhoidal disease. MATERIALS AND METHODS: Since March 2019, 43 patients (24 men and 19 women; mean age, 52 years [18-77 years]) with symptomatic hemorrhoidal disease have been treated and completed the 6-month follow-up with anamnestic questionnaire and disease scores, including French bleeding, Goligher prolapse, visual analog scale for pain, and quality of life. Clinical success was assessed at 7 days, 1 month, and 6 months of follow-up by updating the clinical scores. Statistical analysis was performed using SPSS 25.0. RESULTS: In all, 25 patients had Grade 2 prolapse and 18 patients had Grade 3 prolapse, with 96% and 77%, respectively, having bleeding as a symptom. All patients were discharged within 24 hours. The reduction in the French bleeding score (global and single entity) in Grade 3 prolapse was statistically significant (P = .001). Improvement in the quality of life was significant in both groups (P < .05). No serious complications were registered. CONCLUSIONS: Hemorrhoidal embolization was a safe and effective technique in the treatment of symptomatic hemorrhoidal disease with minimal hospitalization, pain, and disruption of daily activities. It can be offered to patients unwilling to undergo a surgical procedure but can also be indicated in the emergency setting for patients on anticoagulant therapy or those unfit for surgery.

Early and midterm outcomes of endovascular aneurysm repair with an ultra-low-profile endograft from the Triveneto Incraft Registry.

OBJECTIVE: We evaluated the early and midterm outcomes of the Incraft (Cordis Corp, Bridgewater, NJ) ultra-low-profile endograft by analyzing data from the Triveneto Incraft Registry (TIR). METHODS: TIR is an independent multicenter cohort registry of 10 vascular surgery units in the Triveneto area (Northeast Italy). A prospective analysis of patients electively treated with Incraft from September 2014 to June 2019 was performed. The main outcomes were technical success, major 30-day complications, 30-day aneurysm-related death, freedom from reintervention, and mortality rate during follow-up and were analyzed using Kaplan-Meier curves. Univariable Cox regression was used to evaluate the associations between anatomic complexity factors and reintervention. RESULTS: During the study period, 209 patients were included in the registry. Their mean age was 76.9 ± 7.7 years and the Society for Vascular Surgery comorbidity score was 0.97 ± 0.52. Most patients (n = 181; 86.6%) had presented with at least one complex anatomic factor: aortic neck angle α <135° in 31 patients (14.8%), conic neck in 17 patients (8.2%), iliac tortuosity index τ >1.5 in 102 (48.8%), iliac artery calcification >50% in 106 (50.7%), and external iliac artery <6 mm in 45 (21.5%). The concurrent presence of two or more complex iliac anatomic factors was present in 67 patients (32.1%). The technical success rate was 99.5%, and the early major complication rate was 1.5% (one limb occlusion, one iliac branch stenosis, one type III endoleak [EL]). No 30-day mortality was recorded. The mean follow-up period was 18.5 ± 13.2 months. The overall mortality was 9.5% (n = 18), none related to the aneurysm. The freedom from reintervention rate was 92.1%. Of these patients, six (3.2%) had been treated for type II EL embolization, one (0.5%) for type IA EL, four (2.1%) for iliac branch occlusion, and one (0.5%) for flow-limiting external iliac artery dissection. None of the single anatomic factors analyzed were predictive of reintervention. However, the association of two or more complex iliac anatomic factors was predictive of related reintervention (hazard ratio, 7.25; P = .014). The crude reintervention rate in this complex subgroup of patients was low (4 of 67; 6%). CONCLUSIONS: Data from the TIR have demonstrated excellent early and midterm outcomes of endovascular aneurysm repair using the Incraft stent graft in patients with complex anatomy. The concurrent presence of two or more complex iliac anatomic factors still represent an issue for endovascular aneurysm repair success. However, the technical characteristics of this device resulted in low intervention rates, even for patients with these challenging issues.