The Discord Outcome Analysis (DOA) as a Reporting Standard at Three Months and Five Years in Randomised Varicose Vein Treatment Trials.

OBJECTIVES: Treatment success for chronic superficial venous insufficiency could be defined as an improvement in three domains: (i) disease specific quality of life, (ii) clinical severity, (iii) reflux. The aim was to report these at five years using a Venn diagram to profile the outcomes: a discord outcome analysis (DOA). METHODS: Patients (n = 50 patients/legs in each treated group) were randomised to endovenous laser ablation (EVLA) with concurrent phlebectomies vs. ultrasound guided foam sclerotherapy (UGFS). Outcomes were assessed using three domains: (i) Aberdeen varicose vein questionnaire (AVVQ), (ii) venous clinical severity score (VCSS), (iii) venous filling index (VFI) of air plethysmography. Change scores were calculated by subtracting the final score after treatment from the baseline score before treatment to quantify the improvement. This was followed by a DOA profile for each patient where a discord was defined as the percentage of patients with a numerical deterioration in one or two domains. RESULTS: The median [interquartile range] follow up was 68 [64-72] months. Follow up in all three domains was EVLA: 45/50, UGFS: 42/50. On ultrasound examination, GSV occlusion at some point above the knee was 93% for EVLA and 64% for UGFS (p = .001). There was no significant difference in improvement between the two treatment groups in the VCSS and the VFI. However, the EVLA group had a statistically significant AVVQ improvement (p = .004). Using a DOA, only 76% EVLA versus 60% UGFS had success in all three domains. Using improvement thresholds, this reduced to 54% and 39%, respectively. The commonest discord pattern was an improvement in the VCSS and VFI but deterioration in the AVVQ. CONCLUSIONS: A DOA demonstrated that the definition of success is reduced if deterioration in one or two domains is taken into account. A DOA should be considered as a reporting standard for comparative analyses.

Minimum five-year follow-up of posterior-only pedicle screw constructs for thoracic and thoracolumbar kyphosis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To review/report 5-year follow-up data on patients diagnosed with thoracic and thoracolumbar kyphosis (TK/TLK) treated with posterior-only spinal fusion. TK/TLK was initially treated with combined anterior/posterior spinal fusion, evolving into widespread treatment with posterior-only spinal fusion. METHODS: Forty-three patients who underwent a posterior-only spinal fusion for a primary diagnosis of TK/TLK from 1999 to 2009 with > 5-year follow-up were identified. Preoperative/postoperative/final follow-up measurements were recorded from full-length standing radiographs. Prospectively collected outcome scores were reviewed for the same time points, and charts were examined for complications. RESULTS: Patient age averaged 33 years (range 13-77), and follow-up averaged 5.6 years (range 5-12.2). Diagnoses included Scheuermann's disease (N = 15, 35%), idiopathic (N = 10, 23%), pseudarthrosis (N = 6, 14%), iatrogenic (N = 4, 9%), degenerative (N = 3, 7%), post-traumatic (N = 3, 7%), and congenital kyphosis (N = 2, 5%). Average correction of 44.3° (46%; 92.8° preoperatively vs 48.5° postoperatively) was achieved through posterior-only surgery. Loss of correction averaged only 1° in the instrumented segments at final follow-up. Eleven patients had a complication; proximal junctional kyphosis was the most common (N = 3, 7%). One patient lost intraoperative monitoring and one had temporary neurological deterioration postoperatively, but there was no permanent deficit. No pseudarthroses occurred. ODI scores improved 17.2 points on average (p = 0.01). SRS scores improved in all domains (average 0.79, p < 0.001). CONCLUSION: Pedicle screw constructs permit effective posterior-only correction of TK/TLK that is maintained at the 5-year follow-up time point. Patients report improvement, via outcome questionnaires, at the same follow-up time points. These slides can be retrieved under Electronic Supplementary Material.

Assessment of Arterial Stiffness by Cardio-Ankle Vascular Index for Prediction of Five-Year Cardiovascular Events After Coronary Artery Bypass Surgery.

The study aim was to investigate the possibility of cardiovascular complications development predicting during a five-year follow-up of patients after coronary artery bypass grafting (CABG) using the cardio-ankle vascular index (CAVI) assessment. Methods: Three hundred and fifty-six patients after elective CABG were enrolled in the study. Prior to surgery, arterial stiffness was assessed in all patients using CAVI. The follow-up was performed five years after the surgery, information was obtained on 238 patients, who were divided into two groups: patients with pathological (≥9.0, n = 88), and normal (<9.0, n = 150) CAVI. Results: Pathological CAVI (≥9.0) was detected in 33% patients before CABG, in stepwise analyses only age and left atrium dimensions statistically significantly predicted CAVI. In patients with pathological CAVI the combined endpoint (major adverse cardiovascular events and hospitalization) and cardiovascular death developed more often in a five-year follow-up after CABG compared with normal CAVI (48.86% versus 34.9%, p = 0.034 and 4.55% versus 0.67%, p = 0.049, respectively). Pathological CAVI (p = 0.021) and the number of coronary bypass grafts (p = 0.023) were independent factors associated with the combined endpoint. Conclusions: Patients with pathological CAVI before CABG surgery are more likely to develop cardiovascular complications and cardiovascular death within a subsequent five-year follow-up. Evaluation of CAVI after CABG in dynamics deserves further study, it is important for monitoring the effects of secondary prevention and the possibility of influencing the prognosis.

Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system.

OBJECTIVE: This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm. BACKGROUND: The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects. METHODS: In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD. RESULTS: The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2-65) years and a median body weight of 26.7 (10-109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients). CONCLUSION: The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.

Single-visit, 4-site intradermal (ID) rabies vaccination induces robust immune responses 5 years after 1-week, 4-site ID primary post-exposure prophylaxis in the Philippines.

BACKGROUND: In a randomized controlled study (NCT01622062) a 1-week, 4-site intradermal (ID, 4-4-4-0-0) post-exposure prophylaxis (PEP) rabies vaccination regimen with purified Vero cell rabies vaccine (PVRV, Verorab®, Sanofi Pasteur), either without (Group 1) or with (Group 2) purified equine rabies immunoglobulin (ERIG), patients in the Philippines achieved seroconversion rates at Day 14 that were non-inferior to that of the updated Thai Red Cross (TRC) 28-day, 2-site (2-2-2-0-2) ID regimen with ERIG (Group 3). Presented here are the annual immunogenicity data up to five years after the last primary dose, and the immunogenicity and safety data following simulated PEP with single-visit, 4-site ID regimen. METHODS: Rabies virus neutralizing antibodies (RVNA) were determined by rapid fluorescent focus inhibition test (RFFIT). Participants (n = 397) received simulated PEP vaccination ID at Year 5 and RVNAs were assessed at Day 11 post-vaccination. RESULTS: Seroconversion rates (RVNA titres ≥ 0.5 IU/mL) during annual follow-up remained >95% in Group 1 and were relatively stable at 80-90% in Group 2, but decreased from 80% to 64% in Group 3. RVNA geometric mean titres (GMTs) in Group 1 were consistently higher than in the other two groups, and those in Group 3 were generally lower than in the other two groups. There was a clear anamnestic response to vaccination in all groups, with all participants achieving RVNA titres ≥ 0.5 IU/mL at Day 11 post-simulated PEP booster vaccination. There were no safety concerns raised during annual follow-up and with simulated post-exposure vaccination with PVRV. CONCLUSION: The shortened, 1-week, 4-site ID regimen with PVRV achieved persistently higher RVNA titres than the updated 2-site TRC regimen, and more participants remained seroprotected up to five years after the last dose of primary immunization. Simulated post-exposure with 4-site ID rapidly induced an anamnestic response indicative of robust protection.

Clinical and radiography results of mini-plate fixation compared to suture suspensory fixation in cervical laminoplasty: A five-year follow-up study.

OBJECTIVES: Lamina closure is the most common reason for failure of unilateral open-door laminoplasty. Mini-plate fixation was designed to solve such problem. We assessed the clinical outcomes and radiography results of mini-plate fixation by comparing it with suture suspension fixation. PATIENTS AND METHODS: This prospective study enrolled 57 patients with multi-segment cervical spondylotic myelopathy between January 2008 and March 2010. Thirty-four patients underwent laminoplasty with mini-plate fixation (mini-plate group) whereas 23 patients underwent laminoplasty with suture suspension fixation (suture group). The neurological function was measured with the Japanese Orthopedic Association (JOA) score. Cervical range of motion (ROM), C2-7 angle, and the spinal canal expansive parameters (anteroposterior diameter, Pavlov's ratio, cross-sectional area, and open angles) were evaluated. RESULTS: The mean follow-up time was 64 (60-82) months. There were no significant differences in preoperative JOA scores (p=0.191), postoperative JOA scores (p=0.700), preoperative cervical ROM (p=0.315) and preoperative C2-7 angle (p=0.074) between the two groups. Both groups had significant postoperative JOA improvement (p<0.05). The mini-plate group had larger cervical ROM (p=0.041) and C2-7 angle (p=0.040) than the suture group at the final follow-up. Both groups showed significant improvement in the spinal canal expansive parameters immediately after the surgery. In the suture group, the parameters, such as anteroposterior diameter, Pavlov's ratio, cross-sectional area, and open angles, decreased along with time, mainly within the first 6 months following the operation. In the mini-plate group, these parameters remained unchanged. The spinal canal expansive parameters between the 2 groups were not significantly different immediately following the operation, but were significantly different at the final follow-up (p<0.05). Three patients in the suture group displayed neurological deterioration due to lamina reclosure. CONCLUSIONS: Laminoplasty by mini-plate fixation preserved more cervical ROM and better cervical alignment, maintained cervical spine canal expansive stability and effectively avoided lamina reclosure for a long-term follow-up.