One-year Results Research Articles

Graft failure and revision rate after ACL repair with dynamic intraligamentary stabilization. One-year results of a prospective case series of 155 patients

PurposeThe aim of this study was to assess graft failure, revision rate, and functional outcomes after treatment of acute ACL rupture with dynamic intraligamentary stabilization (DIS) Ligamys device one year post surgery. Additionally, differences in functional outcome between patients with and without anteroposterior laxity were assessed. It was hypothesized that the failure rate of DIS was non-inferior to that of previously reported ACL reconstruction (10%).MethodsIn this prospectively designed multicenter study, including patients with an acute ACL rupture, DIS was performed within 21 days after rupture. Primary outcome was failure of the graft at 1 year post surgery, defined as 1) re-rupture of the graft, 2) revision of DIS, or 3) a > 3 mm side-to-side difference in anterior tibial translation compared to the non-operated knee (∆ATT), measured by the KT1000 device. Additional analysis was performed using a 5 mm threshold. The subjective International Knee Documentation Committee Score (IKDC) and Numerical Rating Scales (NRS) for pain and confidence were used to evaluate functional outcome.ResultsA total of 155 patients were included with a mean age at surgery of 27.8 years (SD 9.4). The mean interval from rupture to DIS was 16.4 days (SD 5.2). At a median follow-up of 13 months (IQR 12–18) the failure rate of the graft was 30.2% (95%CI:22.0–39.4); 11 patients (7%) required secondary reconstructive surgery and of the 105 patients who attended ATT measurement, 24 patients (23%) had an ∆ATT > 3 mm. Secondary analysis, based on a 5 mm threshold, revealed a failure rate of 22.4% (95%CI: 15.2; 31.1). A total of 39 patients (25%) reported at least one complication, comprising mainly arthrofibrosis, traumatic re-rupture and pain. In these patients, removal of the monoblock was performed in 21 cases (13.5%). At follow-up no significant differences in functional outcomes between patients with ∆ATT > 3 mm and stable ATT were observed.ConclusionThis prospective multicenter study found a high failure rate at one year follow-up of 30% (7% revision surgery and 23% > 3 mm side-to-side difference in anterior tibial translation) in patients treated by primary repair of the ACL with DIS, and did therefore not demonstrate non-inferiority to ACL reconstruction. For patients who did not require secondary reconstructive surgery, this study found good functional outcomes, also in case of persistent anteroposterior knee laxity (∆ATT > 3 mm).Level of evidenceLevel IV.

The outcome of Transversus Abdominis Release for complex ventral hernia: A one-year of follow-up experience

Introduction: Transversus Abdominis Release is a noble technique for the repair of complex ventral hernia, where the posterior component separation allows a huge pre-peritoneal space advantageous for the placement of large-sized mesh. It has less wound morbidity as compared to anterior component separation due to the preservation of skin perforators. The main objective of this study was to evaluate one-year follow-up results in terms of recurrence, wound morbidity, and various techniques for managing complications of Transversus Abdominis Release. Methods: This is a descriptive crosssectional study that was conducted at the department of surgery, College of Medical Sciences Teaching Hospital. Among 41 patients with complex ventral hernia, 34 patients met the inclusion criteria. Demographic data, intra-operative events like bleeding, operative duration, intraoperative complications, post-operative events like duration of hospital stay, wound morbidity, and follow-up data were analyzed. Results: Posterior rectus sheath closure at midline was possible in 30 (88.2%) patients. In patients, where posterior rectus sheath closure was not possible, the peritoneum of hernia sac was tailored to patch the defect or in some omentum was placed below the raw surface of mesh. The average operative duration and blood losses were 130±12 minutes and 301±133 ml respectively. The semilunar line injury occurred in one case that was diagnosed and repaired at the same time and the TAR plane was re-established. Wound morbidity occurred in three cases that were managed by dressing with commercially available collagen and mupirocin granule. No recurrence was observed in one-year follow-up. Conclusions: Transversus Abdominis Release has a better result with no recurrence in short term follow up and fewer complications which are easily manageable.

Double-center observational study of minimally invasive sacroiliac joint fusion for sacroiliac joint dysfunction: one-year results

BackgroundFor a substantial part of patients with chronic low back pain, the origin is located in the sacroiliac joint (SIJ). Minimally invasive sacroiliac joint fusion (MISJF) is increasingly being implemented as a treatment option in SIJ dysfunction. Despite remaining controversy, evidence continues to increase. This study evaluates the clinical results and safety of MISJF in a double-center consecutive case series in patients with SIJ dysfunction over a one-year observation period.MethodsSIJ complaints were diagnosed after history taking, physical examination and least a 50% reduction of SIJ pain 30–60 min following image-guided injection. Primary outcome measures were patient reported outcome measurements (PROMs), consisting of Visual Analogue Scale (VAS) pain score and EuroQol 5-dimensions 3-levels (EQ-5D-3L). Patients’ perspectives on the effects of surgery were collected through questionnaires. Secondary outcome measures were implant positioning and (serious) adverse events ((S)AE’s).ResultsA total of 29 patients were included. In 44.8% of patients, SIJ dysfunction was of postpartum origin. The mean VAS-pain score improved from 7.83 (± 1.71) to 4.97 (± 2.63) postoperatively (p < 0.001). EQ-5D-3L score improved from 0.266 (± 0.129) to 0.499 (± 0.260) postoperatively (p < 0.001). Opioid consumption decreased from 44.8 to 24.1% postoperatively (p = 0.026). In 13.7% of patients, an (S)AE occurred.ConclusionMISJF appears to be an effective and safe procedure in this cohort. Statistically significant and clinically relevant improvements in pain and quality of life were observed one-year postoperatively. Future studies should focus on the long-term outcomes to further evaluate the safety and effectiveness of MISJF.

One-year results from the Assessing MICRO-vascular resistances via IMR to predict outcome in ST-elevation myocardial infarction patients with multivessel disease undergoing primary PCI (AMICRO) trial.

In ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary angioplasty (PPCI) the index of microcirculatory resistance (IMR) correlates to the extent of myocardial damage and left ventricular (LV) function recovery. Data on the IMR time-course and impact on clinical outcome in STEMI patients with multi-vessel disease (MVD) are scarce. We designed a prospective, multicenter clinical trial to assess the infarct-related artery (IRA)-IMR in STEMI patients with MVD undergoing PPCI and to explore its potential in relationship with outcome and LV remodeling. The study enrolled 242 STEMI patients with MVD. Both fractional flow reserve (FFR) and IMR of the IRA were assessed after successful PPCI. Then, FFR/IMR measurements were repeated in the IRA at a staged angiography, and FFR-guided angioplasty was performed in non-IRA lesions. The primary endpoint was the composite of cardiovascular death, re-infarction, re-hospitalization for heart failure, resuscitation or appropriate ICD shock at 1-year follow-up. A significant improvement of IRA-IMR values (from 47.9 to 34.2, p < 0.0001) was observed early after PPCI. Staged FFR-guided angioplasty was performed in 102 non-IRA lesions. We failed to find a correlation between IRA-IMR, clinical events and LV remodeling. Notwithstanding, in patients with anterior STEMI an inverse correlation between initial IMR values and LV function at follow-up was observed. After successful PPCI, a significant proportion of patients with STEMI and MVD had coronary microvascular dysfunction as assessed by IMR that recovered early after reperfusion. Higher IMR values predicted lack of improvement of LV function only in anterior STEMI. https://clinicaltrials.gov/, identifier [NCT02325973].

LVIS EVO stent-through-balloon after hydrocoil embolization of intracranial aneurysms: One-year results.

To evaluate the durability and safety of complete intracranial aneurysm occlusion at one year using the low-profile braided intracranial LVIS EVO stent. This is a retrospective, monocentric, observational study of unruptured wide-necked intracranial aneurysms treated with the LVIS EVO stent-through-balloon technique after balloon-assisted hydrocoil embolization. Imaging and clinical data were assessed by two blinded independent neuroradiologists and neurologists, respectively. Primary endpoint was complete angiographic occlusion on day 0 and at 12 months. Secondary endpoints included clinical safety using the modified Rankin scale (mRS), ischemic and hemorrhagic adverse events, parent vessel stenosis > 50% or occlusion and retreatment rate. 103 aneurysms in 103 patients were included (53 years-old, 77% women). Mean aneurysm size and neck were 7 and 4 mm, respectively. Complete occlusion was 97% initially and 90% at 12 months, with pending follow up in 17.5% patients. Five patients (5%) with partially stented necks were retreated with a second stent in a T-configuration. Two stents failed to open initially and were immediately retrieved. Asymptomatic parent vessel occlusion and severe in-stent stenosis occurred in 1% and 3%, respectively. The 12-month procedure-related permanent neurological deficit and mortality rates (mRS 3-6) were 2% and 1%, respectively. There was one fatal bleeding but no large ischemic complications. Delivering the LVIS EVO stent through a dual lumen balloon after balloon-assisted hydrocoil embolization yields a high and stable rate of complete aneurysm occlusion at one year with a reasonable immediate and delayed complication rate.

Dysphagia and QoL 3 Years After Treatment of Oropharyngeal Cancer With TORS or Radiotherapy.

To investigate dysphagia and quality of life (QoL) outcomes 3 years after treatment of oropharyngeal cancer with either primary trans oral robotic surgery (TORS) or radiotherapy (RT). A prospective cohort study conducted at the Copenhagen University Hospital. Endpoints were objective swallowing function, examined using fiberoptic endoscopic evaluation of swallowing (FEES) and video fluoroscopy (VF). QoL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30), Head & Neck Module (EORTC QLQ-HN35), and MD Anderson Dysphagia Inventory (MDADI). A comparison was made between 1-, and 3-year results. Forty-four patients were included prior to treatment, 31 treated with TORS and 13 with RT. One-year results for this cohort have previously been published (https://doi.org/10.1080/00016489.2020.1836395). Significant improvement on FEES in retention at the piriform sinus was noted in both groups. Patients treated with TORS had improved safety scores as well as dynamic imaging grade of swallowing toxicity (DIGEST) and efficiency scores, whereas patients treated with RT only had improvements in the latter two. Improvement in QoL scores was only noted for patients treated with TORS in composite MDADI scores. We found significant improvements in objective swallowing function from one to 3 years after treatment, particularly in patients treated with TORS. However, these improvements were not reflected as clinically meaningful improvements in QoL. 3, cohort follow-up study Laryngoscope, 133:1893-1898, 2023.

One-year results from the promise trial, a multi-center prospective study of process optimization with cross-sectoral care for patients receiving hip or knee endoprostheses

Objectives: Knee and hip joint replacements are common procedures in which optimized care processes are applied in many centers. The results for the acute/subacute treatment have consistently been evaluated very positively. However, there is a lack of results results after a longer period.

Retraction of: "Multidisciplinary program based on early management of psychological factors reduces disability of patients with subacute low back pain: one-year results of a randomized controlled study".

Retraction of: “Multidisciplinary program based on early management of psychological factors reduces disability of patients with subacute low back pain: one-year results of a randomized controlled study”

One-year results of minimally invasive fusion surgery of the sacroiliac joint as an alternative treatment after failed endoscopic thermal coagulation.

While pain in the severe sacroiliac joint (SIJ) is a common cause of lower back pain, SIJ disease is often overlooked as a diagnosis. This study examines the extent of sufficient long-term pain relief and functional improvement in patients with SIJ syndrome that are treated with thermocoagulation. Some patients treated with thermocoagulation noted initial improvement, but the functionality and pain relief had limited duration and efficacy. Patients with insufficient improvement were recommended to undergo fusion surgery as an option for better and longer lasting results. Patients with a long history of back or pelvic problems were selected for the study. Endoscopic thermal coagulation of the SIJ was carried out. The follow-up examinations took place after 1, 3, 6, 12 months. In patients with insufficient pain relief and functionality after thermocoagulation, a fusion surgery was performed. The results of the fusion surgery were documented over a 12-month follow-up period. To carry out the statistical evaluation visual analog scale (VAS), Oswestry-Disability-Index (ODI) and the consumption of opioids were recorded. Forty-eight patients were included. The mean VAS values 12 months after thermocoagulation were 68.9. The ODI after 12 months was very near or somewhat higher than their baseline prior to the thermocoagulation. Thus, a fusion surgery was recommended. Thirty-three patients agreed to the fusion operation. The VAS values 12 months after fusion surgery decreased to 53.1. Analogous to the VAS values, the Oswestry index (ODI) showed a significant improvement after the fusion operation. The success of surgical intervention in 88% of the SIJ syndrome patients with inadequate results 12 months after thermocoagulation proves the superiority of SIJ fusion surgery. This study showed long-lasting pain relief by an average of 65% and a median improvement in functional impairments of 60%. In view of these results, fusion surgery should be considered for patients without sufficient success of thermocoagulation.

Ductus Arteriosus Stenting in Neonates with Pulmonary Valve Atresia: Outcomes and Considerations

Background: Patent ductus arteriosus (PDA) stenting was invented particularly for congenital heart diseases with ductal-dependent pulmonary blood flow, and newer techniques are constantly being introduced. Objectives: In this study, we investigate the one-year results of this procedure and describe some of our periprocedural considerations. Methods: The neonates with pulmonary atresia and ventricular septal defect (VSD) who underwent PDA stenting in our center from February 2016 to December 2019 were included in this retrospective study. Spo2 and McGoon ratios were recorded before and a year after stenting and compared to each other. Results: In 26 neonates, PDA stenting was performed; 20 procedures (77%) were successful, and six procedures (23%) were unsuccessful. Two of these unsuccessful cases died during the procedure, and two of them died as a result of neonatal sepsis following the procedure. A total of 18 PDAs (70%) were accessed via the axillary artery, 6 (23%) via the femoral artery, and 2 (7%) via the antegrade inferior vena cava route. The comparison between the results before and one year after stenting revealed the increase of O2 saturation from 53.78 ± 7.35 to 84.33 ± 6.5 (P-value = 0.032) and McGoon ratio from 1.16 ± 0.25 to 1.65 ± 0.34 (P-value = 0.041). Additionally, we discussed some technical considerations of PDA stenting, including the access point, management of pulmonary artery bifurcation stenosis, stent diameter, stenting of long and tortuous PDAs, thrombosis, and anticoagulation. Conclusions: Ductal stenting increases SpO2 and McGoon ratio and could be a less-invasive option for securing pulmonary blood circulation. However, further studies are required to advance PDA stenting techniques for specific anatomical features.

One-year results from the vaccination campaign against COVID-19 infection in 47 million individuals with severe mental disorders and other chronic diseases.

Severe mental disorders have been associated with increased COVID-19 mortality. The aim of this study was to evaluate the results of the vaccination campaign against COVID-19 after 1 year using exhaustive population-based data. In this nationwide population-based study, we used data from the French national medico-administrative database (SNDS) and the COVID Vaccine teleservice from January 4, 2021 (date of activation of the teleservice) to January 30th, 2022. As of January 30th, 2022, the rate of first injection in France was 80.2% (54 million people) and the rate of booster vaccination was 78.3% (52.7 million people). Except for opioid use disorder, all individuals with chronic illnesses or risk factors for poor COVID-19 outcome (e.g., smoking and obesity) had higher rates of vaccination than the general population (from 83.4 to 94.5% vs. 78.3%). However, the four diseases ranking last for both initial and booster vaccinations were mental disorders: alcohol use disorders (86 and 84.3%), neurodevelopmental psychiatric disorders (85.3 and 83.7%), schizophrenia-spectrum disorder (85 and 83.4%) and opioid use disorders (72.9 and 69.4%). Except for opioid disorders, all patients with mental disorders had higher rates of vaccination compared to the general population. However, these rates were lower than other chronic diseases at risk of severe COVID-19 outcomes. Vaccination campaigns must redouble their efforts to improve vaccination penetration in patients with mental disorders.

Myectomy with and without Mitral Subvalvular Repair in Patients with Hypertrophic Obstructive Cardiomyopathy with Grade 3 to 4+ Mitral Regurgitation without Intrinsic Mitral Valve Disease: A Retrospective Observational Study.

Hypertrophic obstructive cardiomyopathy (HOCM) with severe mitral regurgitation (MR) remains controversial for the choice of the concomitant mitral valve (MV) management versus septal myectomy alone. The impacts of different surgical strategies (concomitant mitral subvalvular procedures versus myectomy alone) on one-year results of surgical treatment of HOCM with grade 3 to 4+ MR without intrinsic MV disease were evaluated in this single-center, retrospective observational study. A total of 146 eligible patients were retrospectively screened into a combined group (n = 40) and an alone group (n = 106), depending on whether they underwent transaortic mitral subvalvular procedures. Perioperative outcomes were collected, and results at 1-year following surgery were compared. Surgical mortality did not differ (0 for combined group vs. 0.9% for alone group, p = 0.538). Six patients (5.0% vs. 3.8%, p = 0.666) developed postoperative complete atrioventricular node block with permanent pacemaker implantation. No death or reoperation was recorded during a median follow-up of 18 months. At 1-year following surgery, (1) the provoked MR severity decreased from baseline in both groups with a significant difference between groups [1.0 (0-1.0) vs. 1.0 (1.0-1.3), p 0.001]; (2) systolic anterior motion (SAM) was observed in 10 patients (0 vs. 10 in the alone group, p = 0.043); (3) the provoked gradient was also significantly lower than baseline value for each group, with a significant difference between the two groups (8.8 4.3 mmHg vs. 12.1 6.7 mmHg, p = 0.006); and (4) New York Heart Association class decreased from baseline value for each group (p 0.001). In HOCM patients with grade 3 to 4+ MR without intrinsic MV disease, mitral subvalvular management during septal myectomy may be associated with a low incidence of SAM, improved MR, and a lower outflow tract gradient in comparison with septal myectomy alone.

Influence of microsurgical decompression on segmental stability of the lumbar spine – One-year results in a prospective, consecutive case series using upright, kinetic-positional MRI

BackgroundStandard procedure in patients with lumbar spinal canal stenosis is decompression to relieve the neural structures. Clinical results generally show superiority compared to nonoperative therapy after an observation period of several years. However, there is still a question of postsurgical segmental stability and correlation to clinical findings. Therefore, the aim of this prospective study was to evaluate the clinical outcome in patients who underwent microsurgical decompression in lumbar spine and particularly to analyze intervertebral movement by use of upright, kinetic-positional magnetic resonance imaging (MRI) over a period of 12 months and then to correlate the clinical and imaging data with each other.MethodsComplete clinical data of 24 consecutive participants with microsurgical decompression of the lumbar spine were obtained by questionnaires including visual analogue scale (VAS) for back and leg, Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), Short-Form-36 (SF-36), walking distance and use of analgesics with assessment preoperatively and after 6 weeks and 12 months. At the same points of time all patients underwent upright, kinetic-positional MRI to measure intersegmental motion of the operated levels with determination of intervertebral angles and translation and to correlate the clinical and imaging data with each other.ResultsVAS for leg, ODI, RMDQ and physical component scale of SF-36 improved statistically significantly without statistically significant differences regarding intersegmental motion and horizontal displacement 6 weeks and 12 months after operation. Regression analysis did not find any linear dependencies between the clinical scores and imaging parameters.ConclusionsIn awareness of some limitations of the study, our results demonstrate no increase of intersegmental movement or even instability after microsurgical decompression of the lumbar spine over a follow-up period of 12 months, which is equivalent to preservation of intervertebral stability. Furthermore, the magnitude of intervertebral range of motion showed no correlation to the clinical score parameters at all three examination points of time.

One-Year Results of Occlutech’s Atrial Flow Regulator for Left Atrial Shunting in Symptomatic Heart Failure: The Prelieve Study

One-Year Results of Occlutech’s Atrial Flow Regulator for Left Atrial Shunting in Symptomatic Heart Failure: The Prelieve Study

Radiographic outcomes of lateral sinus floor elevation with and without bone window repositioning: one-year results of a randomized controlled trial

The objective of this study was to perform a comparative evaluation of the radiographic outcomes of lateral sinus floor elevation with and without bone window repositioning (BLSFE and LSFE, respectively) when applied concomitantly with implant placement. A randomized controlled clinical trial was conducted between February 1, 2016 and May 1, 2017 including 26 individuals with at least one missing tooth. Participants were randomized 1:1 to undergo BLSFE (10 participants, 16 implants) or LSFE (13 participants, 19 implants). Bovine-derived xenograft was used in both groups and the implants were inserted concomitantly. In the BLSFE group, the antrostomy was covered with a repositioned bone window and then with a concentrated growth factors (CGF) membrane. In the LSFE group, the antrostomy was covered with a CGF membrane. Panoramic radiographs were taken before surgery (T0), immediately postoperative (T1), and at 12 months postoperative (6 months after loading) (T2). Marginal bone loss (MBL), apical bone gain, augmented alveolar bone height, and intra-sinus bone augmentation were evaluated on panoramic radiographs at T2. A linear regression analysis with generalized estimating equation models was performed. The implant survival rate was 100% at 1 year after implant surgery. The residual alveolar bone height at T0 was comparable in the BLSFE and LSFE groups (3.58 ± 1.49 mm vs 4.12 ± 1.61, P = 0.32), as was the alveolar bone height at T1 (13.61 ± 1.82 mm vs 12.38 ± 1.82 mm, P = 0.06). At T2, significantly higher alveolar bone height, intra-sinus bone augmentation, and apical bone gain, and lower distal MBL were observed in the BLSFE group when compared to the LSFE group, with adjusting for covariates (β = 2.44, 95% CI 1.42–3.46, P < 0.0001; β = 2.38, 95% CI 1.35–3.41, P < 0.0001; β = 2.33, 95% CI 1.23–3.42, P < 0.0001; and β = −0.43, 95% CI −0.83 to −0.02, P = 0.038, respectively). No significant difference was observed for mesial MBL or apical bone resorption at T2. Lateral sinus floor elevation with bone window repositioning may result in higher bone augmentation after 1 year than the traditional approach. Further research is needed to elucidate the effect of lateral sinus floor elevation with bone window repositioning.

Comparison of accelerated corneal cross-linking for progressive keratoconus in pediatric and adult age groups: One-year results

To compare one-year results of accelerated cross-linking (ACXL) treatment for progressive keratoconus in pediatric and adult age groups. The records of patients who had undergone the ACXL procedure (9mV/cm2, 10min) for progressive keratoconus were evaluated retrospectively. The patients were divided into 2 groups, with the pediatric group aged 17years or less and the adult group aged 18years or more, for the statistical analysis. Pre- and 12-month post- ACXL best-corrected visual acuity (BCVA), maximum keratometry (Kmax), sim K1, sim K2, corneal thickness at the thinnest point (thCT), and corneal astigmatism (CA) values of the patient groups were recorded. Thirty-two right eyes of 32 patients were included in the pediatric group, and 32 right eyes of 32 patients were included in the adult group. A significant improvement in BCVA and a significant decrease in thCT values were present in both groups 12months after the surgery compared to the preoperative period. The decrease in Kmax, sim K1 and sim K2 values compared to the preoperative period was significant in the adult group. When the two groups were compared after 12months, only the simK1 value was significantly lower in the adult group, and there was no significant difference between the other measurements. There is a slight tendency toward more flattening in the adult group 12months after ACXL treatment, but this is not statistically significant.

Cerebral Ischemic Events Ipsilateral to Carotid Artery Stenosis. The Carotid Asymptomatic Stenosis (CARAS) Observational Study: First Year Preliminary Results

To report the characteristics of the prospective observational cohort study "Carotid Asymptomatic Stenosis (CARAS)", including patients with asymptomatic carotid stenosis under medical treatment and their first year of follow-up, in order to estimate the risk of cerebral ischemic events. This is a prospective observational cohort study of CARAS>60% (Nascet criteria) patients, identified in a single duplex-ultrasonography (DUS) vascular laboratory (trail registration N: NCT04825080). Patient's enrollment started in January 2019 and ended in March 2020 with the follow-up conclusion scheduled in December 2025. The aimed sample size was calculated at 300 patients for a 5-year follow-up. The primary outcome were the incidence of ipsilateral neurologic ischemic events (stokes and transient ischemic attacks [TIA]), plaque progression rate, and survival. The follow-up was scheduled at six-month intervals for clinical visit and annually for DUS examination. a total of 307 patients completed the first follow-up year. The mean age was 81±4 years, 55% were male. Contralateral stenosis >60% was present in 90 (29%) patients. Antiplatelet therapy and statins adherence was 80% and 88%, respectively. During the first year, 3 ispilateral strokes (1%) and 4 TIAs (1.3%) occurred, for a total of 2.3% ipsilateral ischemic events. During the first year, 43 (14%) plaques had a stenosis progression, which was correlated with the occurrence of neurological events (9.3% vs. 1.1%, P=.001, OR: 8.9; 95%CI: 1.9-41); 6 deaths (2%) occurred in the same period. the preliminary one-year results of this prospective study suggest that the overall rate of any ipsilateral ischemic event, and specifically ipsilateral strokes, correlates with plaque progression.

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial

ObjectiveTo report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial. MethodsThe study is a prospective, multicenter, investigational device exemption clinical trial at 31 US sites with core laboratory assessment of imaging and independent event adjudication. The primary safety (incidence of major adverse events at 30 days) and effectiveness end points (successful aneurysm treatment at 1 year) were assessed in a cohort of patients with abdominal aortic aneurysms (AAAs). ResultsWe enrolled 80 patients between December 19, 2017, and February, 27, 2019. The mean maximum aortic diameter was 57.7 ± 7.95 mm (range, 42.5-82.7 mm) with an average patient age of 73.5 ± 8.14 years (range, 56-96 years). Overall technical success was 100% (80/80). The mean hospital length stay was 1.2 ± 0.6 days (range, 1-4 days). No primary safety end point events were observed, including no death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, procedural blood loss of more than 1000 mL, or thromboembolic events including limb occlusion or distal emboli. There were no type I or III endoleaks detected on the 1-, 6-, or 12-month follow-up computed tomography scans. There were no stent fractures, device migrations (≥10 mm), AAA ruptures, or conversions to open surgical repair observed. Two patients had AAA sac growth of more than 5 mm at 1 year owing to type II endoleaks. There were no aneurysm-related deaths within the 12-month follow-up, and freedom from aneurysm-related mortality was 100% through 1 year. ConclusionsThe safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system has been demonstrated with 98.5% freedom from primary effectiveness end point events at 1 year and 100% freedom from primary safety end point events assessed through 30 days.

Outcome oriented clinical research and quality measurement in fracture care

Abstract Objective The paradigm shift according to the principles of Value-Based Healthcare is receiving growing attention. In Orthopedic Trauma care, there are no defined standards to provide an incentive system to recompensate for quality instead of quantity. The definitions of quality from the patient's view have to be validated and included in the reimbursement cycle. In our Department, we now have fully standardized and structured documentation and outcome measurement workflow from the clinical point of view. Methods We set up a Fracture Registry with a REDCap® Database to document every patient with surgical treatment. Included are all surgically treated fractures of the extremities, excluding the hand. Furthermore pelvic, acetabular, and periprosthetic fractures, joint dislocations, and tendon ruptures. With interfaces to our Clinical Documentation Systems, the administrative effort became very efficient. The interfaces provide a possibility to identify every patient with inclusion criteria and implement reminder feedback for Surgeons. We collect PROMs with the heartbeat-Software, and document CROMs with REDCap®. We merged these data using the software ‘R’. The documentation of each patient is completed with a database for Adverse Events. Results Data-entry rates were less than 50% in 2018 and have reached 99.1% for 2020 and 99.5% for 2021 for surgically treated fracture patients. Until the submission of this abstract, 2382 surgical procedures have been performed at our Department on 2073 hospitalized patients. 972 patients were included in the Fracture Registry (47%). In a feasibility study, we have merged clinical data with the PROMs of patients treated for distal radius (DR) and proximal humerus (PH) fractures. The baseline values for DR of the quality-of-life questionnaire EQ5D was 0.83 (n=144), after 3months 0.9 (n=58) and 0.97 one year after treatment (n=6). Although not more than a trend, we realized the same pattern for PH-patients with an EQ5D-Baseline of 0.75 (n=63), three months values of 0.75 (n=58), and one-year results of 0.87 (n=6). Conclusion Collecting structured data allows combining routine clinical data with PROMs and CROMs. This information is of inestimable value to define the quality of care for Orthopedic Trauma Surgery. Our combination of Databases to collect diagnosis, subjective and objective outcome measures has been proven feasible and showed high data quality.

Radiation Oncology AcaDemic Mentorship Program (ROADMAP) for Junior Faculty: One-Year Results of a Prospective Single Institution Initiative

Although mentorship has been associated with promotion, job satisfaction, and retention, data are limited on the mentorship experience of clinical- versus research-track physicians as well as feasibility and relative priority of formal program components. Within a single-institution, multi-site, academic network, we implemented a Radiation Oncology AcaDemic Mentorship Program (ROADMAP) for junior faculty. Validated surveys assessing mentee satisfaction were distributed at baseline and 1 year. The statistical analysis included Wilcoxon rank sum and signed tests. Mentees assessed the likelihood to recommend each program component (10-point Likert-type scale), and means with standard error (SE) are reported. Among 42 eligible junior faculty, 36 (86%) opted into the program. The median time since residency was 2.5 years (interquartile range, 1.75-5.25) on the clinical track (n = 12) and 3 years (interquartile range, 2.75-5.00) on the research track (n = 24). At baseline, research-track physicians reported higher satisfaction with mentoring than physicians on the clinical track (2.92 vs 2.16; P = .02). Among 32 physicians completing 1 year, overall satisfaction with mentoring increased compared with baseline (2.72 vs 3.87; P < .001), which persisted on subset analysis for both clinical- (2.16 vs 4.03; P < .001) and research-track physicians (2.99 vs 3.77; P = .005). At 1 year, 28 mentees (88%) opted to continue the program. Program components were rated 8.25 (SE, 0.37) for mentor-mentee pairings, 7.22 (SE, 0.39) for goal setting, 6.84 (SE, 0.47) for administrative support, 6.69 (SE, 0.44) for peer mentoring, and 6.53 (SE, 0.45) for steering committee oversight. Ratings of peer mentoring were not associated with track (P = .59) or years in practice (P = .29). Clinical-track physicians may be less satisfied with mentorship than research-track faculty. However, all junior faculty, regardless of track, appeared to benefit from formalizing dyadic mentor-mentee relationships, goal setting, and peer mentoring. Further work is needed to determine the role of mentorship in addressing physician burnout.