ABSTRACT
OBJECTIVE: Conflicting evidence exists on the effects of hyperbaric oxygen therapy (HBOT) in the treatment of chronic ischemic leg ulcers. The aim of this trial was to investigate whether additional HBOT would benefit patients with diabetes and ischemic leg ulcers. RESEARCH DESIGN AND METHODS: Patients with diabetes with an ischemic wound (n = 120) were randomized to standard care (SC) without or with HBOT (SC+HBOT). Primary outcomes were limb salvage and wound healing after 12 months, as well as time to wound healing. Other end points were amputation-free survival (AFS) and mortality. RESULTS: Both groups contained 60 patients. Limb salvage was achieved in 47 patients in the SC group vs. 53 patients in the SC+HBOT group (risk difference [RD] 10% [95% CI -4 to 23]). After 12 months, 28 index wounds were healed in the SC group vs. 30 in the SC+HBOT group (RD 3% [95% CI -14 to 21]). AFS was achieved in 41 patients in the SC group and 49 patients in the SC+HBOT group (RD 13% [95% CI -2 to 28]). In the SC+HBOT group, 21 patients (35%) were unable to complete the HBOT protocol as planned. Those who did had significantly fewer major amputations and higher AFS (RD for AFS 26% [95% CI 10-38]). CONCLUSIONS: Additional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia.
Subject(s)
Diabetes Mellitus, Type 2/therapy , Hyperbaric Oxygenation , Ischemia/therapy , Limb Salvage , Ulcer/therapy , Wound Healing , Aged , Aged, 80 and over , Amputation, Surgical , Body Mass Index , Female , Follow-Up Studies , Humans , Male , Middle Aged , Sample Size , Treatment OutcomeABSTRACT
A 51-year-old man had a paresis of the right side of the lower lip after carotic endarterectomy. The diagnosis was 'pressure neuropathy of the right ramus marginalis mandibulae' caused by the operation. This neuropathy is self limiting.
Subject(s)
Endarterectomy, Carotid/adverse effects , Facial Muscles/innervation , Facial Paralysis/diagnosis , Facial Paralysis/etiology , Lip/innervation , Facial Expression , Humans , Male , Mandible , Middle Aged , SmilingABSTRACT
OBJECTIVES: The purpose of this study was to assess the value of preoperative cardiac testing in intermediate-risk patients receiving beta-blocker therapy with tight heart rate (HR) control scheduled for major vascular surgery. BACKGROUND: Treatment guidelines of the American College of Cardiology/American Heart Association recommend cardiac testing in these patients to identify subjects at increased risk. This policy delays surgery, even though test results might be redundant and beta-blockers with tight HR control provide sufficient myocardial protection. Furthermore, the benefit of revascularization in high-risk patients is ill-defined. METHODS: All 1,476 screened patients were stratified into low-risk (0 risk factors), intermediate-risk (1 to 2 risk factors), and high-risk (> or =3 risk factors). All patients received beta-blockers. The 770 intermediate-risk patients were randomly assigned to cardiac stress-testing (n = 386) or no testing. Test results influenced management. In patients with ischemia, physicians aimed to control HR below the ischemic threshold. Those with extensive stress-induced ischemia were considered for revascularization. The primary end point was cardiac death or myocardial infarction at 30-days after surgery. RESULTS: Testing showed no ischemia in 287 patients (74%); limited ischemia in 65 patients (17%), and extensive ischemia in 34 patients (8.8%). Of 34 patients with extensive ischemia, revascularization before surgery was feasible in 12 patients (35%). Patients assigned to no testing had similar incidence of the primary end point as those assigned to testing (1.8% vs. 2.3%; odds ratio [OR] 0.78; 95% confidence interval [CI] 0.28 to 2.1; p = 0.62). The strategy of no testing brought surgery almost 3 weeks forward. Regardless of allocated strategy, patients with a HR <65 beats/min had lower risk than the remaining patients (1.3% vs. 5.2%; OR 0.24; 95% CI 0.09 to 0.66; p = 0.003). CONCLUSIONS: Cardiac testing can safely be omitted in intermediate-risk patients, provided that beta-blockers aiming at tight HR control are prescribed.
