Improving Shared Decision Making in Vascular Surgery: A Stepped Wedge Cluster Randomised Trial.

OBJECTIVE: Different treatment options are available and feasible for various vascular surgical disorders. Hence, vascular surgery seems an area par excellence for shared decision making (SDM), in which clinicians incorporate the patient's preferences into the final treatment decision. However, current SDM levels in vascular surgical outpatient clinics are below expectations. To improve this, different decision support tools (DSTs) have been developed: online patient decision aids, consultation cards, and decision cards. METHODS: This stepped wedge cluster randomised trial was conducted in 13 Dutch hospitals. Besides the developed DSTs, training on how to apply SDM during the clinician patient encounter was used in this study. Data were obtained via questionnaires and audio recordings. The primary outcome was the OPTION-5 score, an objective tool to assess the level of SDM, expressed as a percentage of exemplary performance. Main secondary outcomes were patients' disease specific knowledge, consultation duration, and treatment choice. Factors influencing OPTION-5 scores were studied using linear regression analysis. RESULTS: Included in the study were 342 patients with an abdominal aortic aneurysm (AAA; n = 87), intermittent claudication (IC; n = 143), or varicose veins (VV; n = 112). Audiotapes of 395 consultations were analysed. Overall the mean OPTION-5 score significantly improved from 28.7% to 37.8% (mean difference 9.1%, 95% CI 6.5% - 11.8%) after implementation of the DSTs. Also, patient knowledge increased significantly (median increase: 13%, effect size: 0.13, p = .025). The number of patients choosing non-surgical treatment choices increased, with 21.4% to 28.8% for patients with AAA and doubled (16.0% to 32.0%) among patients with IC. For surgeons, the SDM training and for patients the decision aid significantly and independently increased OPTION-5 scores (p < .001 and p = .047, respectively). CONCLUSION: Introducing DSTs improves the level of shared decision making in vascular surgery, improves patient knowledge, and shifts their preference towards more non-surgical treatments. The SDM training for clinicians and the decision aid for patients appeared the most effective means of improving SDM. TRIAL REGISTRATION: NTR6487.

Surgical Treatment of Diabetic Foot Ulcers Complicated by Osteomyelitis with Gentamicin-Loaded Calcium Sulphate-Hydroxyapatite Biocomposite.

Diabetic foot ulcers, complicated by osteomyelitis, can be treated by surgical resection, dead space filling with gentamicin-loaded calcium sulphate-hydroxyapatite (CaS-HA) biocomposite, and closure of soft tissues and skin. To assess the feasibility of this treatment regimen, we conducted a multicenter retrospective cohort study of patients after failed conventional treatments. From 13 hospitals we included 64 patients with forefoot (n = 41 (64%)), midfoot (n = 14 (22%)), or hindfoot (n = 9 (14%)) ulcers complicated by osteomyelitis. Median follow-up was 43 (interquartile range, 20-61) weeks. We observed wound healing in 54 patients (84%) and treatment success (wound healing without ulcer recurrence) in 42 patients (66%). Treatment failures (no wound healing or ulcer recurrence) led to minor amputations in four patients (6%) and major amputations in seven patients (11%). Factors associated with treatment failures in univariable Cox regression analysis were gentamicin-resistant osteomyelitis (hazard ratio (HR), 3.847; 95%-confidence interval (CI), 1.065-13.899), hindfoot ulcers (HR, 3.624; 95%-CI, 1.187-11.060) and surgical procedures with gentamicin-loaded CaS-HA biocomposite that involved minor amputations (HR, 3.965; 95%-CI, 1.608-9.777). In this study of patients with diabetic foot ulcers, complicated by osteomyelitis, surgical treatment with gentamicin-loaded CaS-HA biocomposite was feasible and successful in 66% of patients. A prospective trial of this treatment regimen, based on a uniform treatment protocol, is required.

Midterm outcome of balloon-expandable polytetrafluoroethylene-covered stents in the treatment of iliac artery chronic occlusive disease.

PURPOSE: To evaluate the 4-year results of polytetrafluoroethylene (PTFE)-covered stents in the treatment of iliac artery occlusive disease. METHODS: Between January 2003 and September 2010, PTFE-covered stents were implanted in 115 iliac arteries of 87 patients (73 men; mean age 60 ± 11 years) in a single center. The lesions were classified as TASC II A (n=40), B (n=41), C (n=7), and D (n=27). There were 69 primary endograft placements, while 46 procedures were performed after previous bare metal stent placement (reintervention group). Follow-up consisted of clinical investigation, ankle-brachial index (ABI) measurement, and duplex ultrasound scanning. In this retrospective analysis, outcomes were reported on a per-limb basis. RESULTS: The median Rutherford classification decreased from category 3 at baseline to 0 after the procedure (p<0.001) and the ABI increased from 0.66 ± 0.24 to 0.89 ± 0.21 (p<0.001). The primary limb patency was significantly higher in the primary treatment group (p=0.03): 88.7% at 1 year, 86.4% at 2 years, and 71.5% at 4 years compared to the reintervention group (77.9%, 72.1%, and 53.0%, respectively). Univariate analysis revealed prior stent placement as the only factor associated with loss of primary patency. The freedom from target lesion revascularization (TLR) in the primary treatment group was 95.2% at 1 year, 89.6% at 2 years, and 74.4% at 4 years, which did not differ significantly from rates in the reintervention group (88.0%, 82.3%, and 63.8%, respectively). CONCLUSION: The use of PTFE-covered stents for occlusive disease in the iliac arteries is related to satisfactory limb patency rates and high freedom from TLR. Previous stent placement was related to a lower primary patency rate. Additional studies are indicated to establish subgroups that may specifically benefit from covered stents.