Purpose: To evaluate the roles of small artery disease (SAD) and medial arterial calcification (MAC) in patients with chronic limb-threatening ischemia (CLTI) and to identify any correlation between these factors and peripheral artery disease (PAD) or outcomes after treatment. Materials and Methods: A retrospective review was conducted of 259 limbs with tissue loss among 223 CLTI patients (mean age 72.2±11.4 years; 194 men) having an angiographic foot vessel study, foot radiography, and at least 6 months of follow-up after intervention. SAD and MAC were quantified using a 3-level score (0=absent, 1=moderate, 2=severe) based on angiography for SAD and foot radiographs for MAC. The MAC score was validated and compared with the SAD score, evaluating their associations with PAD distribution and clinical outcomes. Results: Based on the MAC score, the 259 limbs were classified as 55 group 0 (21.2%), 89 group 1 (34.4%), and 115 group 2 (44.4%). The SAD score stratified the 259 limbs as 67 group 0 (25.9%), 76 group 1 (29.3%), and 116 group 2 (44.8%). Interobserver reproducibility of the MAC score was high (correlation coefficient 0.96). Sensitivity and specificity of the MAC score in detecting SAD was 100% and 98.1%, respectively, in SAD groups 0 and 2 vs 99.1% and 92.7%, respectively, for SAD group 1. PAD was more proximal in MAC and SAD groups 0 and more distal in groups 1 and 2. Both MAC and SAD scores were able to predict clinical endpoints. Multivariable analysis demonstrated that the MAC score represents an independent risk factor for adverse limb events. Conclusion: SAD and MAC must be considered expressions of the same obstructing disease, able to adversely impact the fate of CLTI patients. SAD and MAC scores are powerful prognostic indicators of major adverse limb events in CLTI patients.
Objective: To evaluate the GORE ® Cardioform ASD Occluder (GCO) (WL Gore & Associates, Flagstaff, AZ) device for "complex" atrial septal defects (ASD) closure.Background: Transcatheter ASD closure is still challenging in "complex" clinical/ anatomic settings. This study evaluated the results of GCO in closure of "complex" ASD in a tertiary referral center.Methods: Between January 2020 and March 2021, 72 patients with significant ASD were submitted to transcatheter closure with GCO at our Institution. Based on clinical/anatomic characteristics, they were classified as "complex" (n = 36, Group I) or "simple" (n = 36, Group II). We considered as "complex", defects with rim deficiency (< 5 mm) other than antero-superior, relatively large (diameter/patient weight > 1.2 or diameter/patient BSA > 20 mm/m 2 ) or within a multifenestrated septum. Procedure results and early outcome were compared between the groups.Results: Absolute and relative ASD size (20 ± 4 vs. 15 ± 3 mm, p < 0.0001; 0.9 ± 0.3 vs. 0.4 ± 0.2 mm/kg, p < 0.0001; 23 ± 7 vs. 12 ± 5 mm/m 2 , p < 0.0001), QP/QS (2.0 ± 0.8 vs. 1.4 ± 0.3, p < 0.001), procedure and fluoroscopy times (73 ± 36 vs. 43 ± 21 min, p < 0.0001; 16 ± 9 vs. 9 ± 4 min, p < 0.0001, procedure feasibility (94.4 vs. 100%, p < 0.0001) and overall complication rate (13.9 vs. 0%, p < 0.0001) were significantly different between the groups. Successful closure of "surgical" ASDs was achieved in 92% of cases. Complete closure at last follow-up evaluation did not significantly differ between the groups (97.1 vs. 100%, p = NS), as was wireframe fractures rate (49.1% in the overall population), without clinical, EKG and echocardiographic consequences.Conclusions: Percutaneous treatment with GCO device is effective and safe in high percentage of "complex" ASDs.
Aim To report on the feasibility, efficacy and long-term outcome of transcatheter closure of fenestrated Atrial Septal Aneurysm (ASA).Methods Between April 2000 and May 2020, 568 patients with fenestrated ASA underwent transcatheter closure at two large-volume Pediatric Cardiology and GUCH Units (Naples and Massa, Italy). Procedural indications were cardiac volume overload in 223 patients (39%) or prophylaxis of paradoxical embolization in 345 patients (61%). Patients' median age and weight were 42 years (range 19-52) and 66 kg (range 54-79), respectively. One-hundred and thirty-nine patients (25%) were younger than 18 years.Results Single fenestration was found in 311 patients (55%) (Group 1), whereas 257 patients (45%) had multifenestrated ASA (Group 2). The procedure was successful in all but seven patients (1.2%). In Group 1, closure was achieved with a single device. In Group 2, one device was used in 168 patients (67%), two devices in 74 patients (28%), three devices in 12 patients (5%), and four devices in 1 patient (0.3%). The early complication rate was 3%, without any difference according to anatomy or patient's age. At discharge, complete shunt closure was higher in Group 1 (92% vs. 72%, P < 0.0001), without any difference between groups at the last follow-up evaluation (100% vs. 99%, P U 0.12). Procedural safety was persistent during the long-term follow-up (mean 7.2 W 5.4, range 0-19 years): freedom from adverse events was 97% at 10-15 years. Seventeen patients (3%) were submitted to reintervention, mostly as prophylaxis of paradoxical embolization. ConclusionTranscatheter closure of perforated ASA is technically feasible in a high percentage of cases, with excellent long-term outcomes.
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