The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore - 12 Months Results of the PRISTINE Registry.

PURPOSE: The aim of PRISTINE was to evaluate the 6 and 12 months safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon for treatment of complex lower limb occlusive lesions (TASC II C & D) in patients with chronic limb threatening ischemia (CLTI) from Singapore. METHODS: PRISTINE was a prospective, non-randomized, single arm, observational, multi-investigator, single-center clinical study. Complication-free survival at 30 days was the safety clinical endpoint. Immediate technical success (ability to cross and dilate the lesion and achieve residual angiographic stenosis < 30%), 6-month primary vessel patency, limb salvage, clinically driven target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. RESULTS: Seventy five patients were included. There were 50 (68.0%) males; mean age, 69.0 ± 10.7 years. CLTI severity was based on the Rutherford Scale (R5 = 51; R6 = 17). Significant co-morbidities included diabetes mellitus (n = 68; 91.0%) and end-stage renal failure (n = 28; 37.0%). 112 atherosclerotic lesions were treated (TASC II D = 58 (52%); 76 (67%) de novo). There was 100% technical success. Mean lesion length treated was 22.4 ± 13.9 cm. Primary vessel patencies at 6 and 12 months were 64/86 (74%) and 43/74 (58%) and freedom from clinically driven TLR were 72/86 (84%) and 55/74 (74%) respectively. AFS was 61/73 (84.0%; five deaths and seven major lower extremity amputation) at 6-months. Mean Rutherford score improved from 5.1 ± 0.55 at baseline to 1.1 ± 2.05 (p < 0.05) at one year and there was a wound healing rate of 38/48 (79%) at the same timepoint. CONCLUSIONS: The Selution SLR™ drug eluting balloon is safe and efficacious in treating highly complex infra-inguinal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of diabetes and end-stage renal failure. It is associated with highly satisfactory acute technical and clinical success, 12-month target lesion patency and AFS. LEVEL OF EVIDENCE: Level 2b, Individual Cohort Study.

Retrograde embolisation of varicocele in the paediatric age group: a review of 10 years' practice.

OBJECTIVE: To review the 10 years' practice of retrograde embolisation of varicoceles in the paediatric age group. PATIENTS AND METHODS: 40 boys (age range, 6-16 years), with varicocele diagnosed both clinically and sonographically, were referred to the radiology department for embolisation. Data of these patients were collected and analysed retrospectively. Patients' age, side, treatment, complications, and outcome were noted. The follow-up ranges from 2 months to 6 years (mean, 1.1 years). RESULTS: In 24 patients (60%), embolisation was successful at the first attempt and 11 procedures (27.5%) were technical failures; 4 patients (10%) after venography were considered non-embolisable. One patient (2.5%) is yet to be seen in the clinic. Recurrence occurred in 4 patients (10%) of whom 3 had successful repeat embolisation. One patient with a recurrent varicocele did not wish further treatment. Out of the 11 failures, 5 underwent repeat embolisation with success in 3 patients and failure in two. Four patients had successful surgical ligation and 2 patients were treated conservatively. All who were non-embolisable were treated successfully by surgery. Our overall success rate was 65% (n = 26). CONCLUSIONS: These results suggest that embolisation is valuable as a first line of treatment for paediatric varicoceles provided a skilled interventional radiologist is available. This procedure is less invasive, avoids general anaesthetic, involves minimal postoperative pain, and allows an earlier return to normal activities. However, 35% of patients did eventually require conventional surgery for primary failure of embolisation or late recurrence.