Objectives
To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia.
Background
The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug‐eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long‐term inflammation. BVSs are biodegradable scaffolds that provide short‐term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12‐month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS.
Methods
This single‐center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly‐L‐lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD‐TVF) at 12 months.
Results
Thirty‐one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80–100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD‐TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford–Becker classification.
Conclusions
At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD‐TVF.
When used in a moving ambulance, the POC device provided results of cardiac troponin I assays that were highly correlated to the results when the device was used in the ED. The feasibility, practicality, and clinical utility of prehospital use of POC devices must still be assessed. Key words: point-of-care systems; prehospital emergency care; troponin; reliability of results; ambulances; myocardial infarction; chest pain.
Objectives To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. Methods This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. Results 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80–100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. Conclusions At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.
Background
Patent foramen ovale (PFO) has been linked to cryptogenic stroke, and closure has been reported to improve clinical outcomes. However, there are no clear guidelines to direct device sizing. This study sought to use patient characteristics and echocardiographic findings to create a prediction score for device sizing.
Methods
This was a retrospective review of patients undergoing percutaneous PFO closure at our institution between July 2010 and December 2014. Demographic and clinical characteristics were recorded, and all pre- and intraprocedural echocardiography results were evaluated.
Results
Thirty-six patients underwent percutaneous PFO closure during the study period. All procedures were performed using an Amplatzer Septal Occluder “Cribriform” (ASOC) device in one of three disc diameters: 25, 30, or 35 mm. Closure was indicated for cryptogenic stroke/transient ischemic attack in 75% of cases. Every case (100%) was successful with durable shunt correction at the 6-month follow-up without complications of erosion or device embolization. The presence of atrial septal aneurysm (ASA) (p = 0.027) and PFO tunnel length >10 mm (p = 0.038) were independently associated with increased device size. A scoring system of 1 point for male sex, 1 point for ASA, and 1 point for PFO tunnel >10 mm long was associated with the size of closure device implanted (p = 0.006).
Conclusions
A simple scoring system may be used to select an optimally sized device for percutaneous PFO closure using the ASOC device.
Background: The transradial approach (TRA) for catheter interventions decreases vascular complications and bleeding versus transfemoral approach. Reducing time to hemostasis and preventing radial artery occlusion (RAO) following TRA are important and incompletely realized aspirations.Objectives: This first-in-human study sought to evaluate the efficacy of a novel, topically applied compound (hydrophobically modified polysaccharide-chitosan, hm-P) plus minimal required pneumatic compression, to achieve rapid radial arterial hemostasis in post-TRA procedures compared with de facto standards.Materials and Methods: About 50 adult patients undergoing 6 French diagnostic TRA procedures were prospectively enrolled. At procedure completion, a topical hm-P impregnated patch was placed over the dermotomy and TR Band (TRB) compression was applied to the access site. This patch was used as part of a novel rapid deflation protocol with a primary outcome of time to hemostasis. Photographic and vascular ultrasound evaluation of the radial artery was performed to evaluate the procedural site.Results: Time to hemostasis was 40.5 min (IQR: 38-50 min) with the majority of patients (n = 39, 78%) not requiring reinflation. Patients with bleeding requiring TRB reinflation were more likely to have low body weight and liver dysfunction, with absence of hypertension and LV dysfunction. The rate of RAO was 0% with predischarge radial artery patency documented in all patients using vascular ultrasound. One superficial hematoma was noted. No late bleeding events or cutaneous reactions were reported in the study follow-up.Conclusions: Topical application of hm-P in conjunction with pneumatic compression was safe and resulted in rapid and predictable hemostasis at the arterial puncture site.
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