Project description:AimsData on long-term treatment effects are scarce, despite the intent to use new therapies for many years and the need of patients, physicians and payers to have a better understanding of the lifetime benefits of treatments. The restricted mean or median survival time (RMST) calculated using age instead of time, hypothetically enables estimation of long-term gain in event-free or overall survival from the short-term (within-trial) effects of an intervention, compared with its control. Tha aim of the study is to use trials with long-term follow-up available through extension studies to compare the long-term projections estimated using RMST from within-trial follow-up data with the actual long-term outcomes in the extension studies.Methods and resultsWe estimated the median long-term survival time using age instead of follow-up time and compared these model-based projections with the actual long-term estimates in the (i) SCD-HeFT trial vs. SCD-HeFT long-term outcomes; (ii) SOLVD trial vs. SOLVD 12 year follow-up; (iii) STICH trial vs. STICHES; and (iv) ACCORD study vs. ACCORDION. In the long-term follow-up of SCD-HeFT, gain in survival with ICD vs. placebo over a median of 11.0 years was +1.4 years of life. The RMST model-derived survival projection from the within-trial data (median follow-up of 3.4 years) gave an estimated survival gain of +1.2 years. In STICHES, over a median follow-up of 9.8 years, coronary artery bypass grafting (CABG) vs. medical care led to a survival extension of +1.4 years in favour of CABG. RMST projections using within-trial data from STICH (median follow-up of 4.9 years), gave an extended survival of +2.4 years in favour of CABG in younger patients. In the long-term follow-up of SOLVD, enalapril vs. placebo led to a survival gain of +0.8 years over a median follow-up of 12.1 years. The RMST projections from the within-trial data (median follow-up of 2.8 years) gave a survival extension of +0.3 years in favour of enalapril. In the long-term follow-up ACCORDION study, with a median follow-up of 8.8 years, intensive vs. a standard anti-hyperglycaemic treatment did not influence long-term survival, which was concordant with the RMST projections from the short-term ACCORD study with median follow-up of 4.9 years.ConclusionsAge-based survival projections using within-trial data generally provided concordant results with the actual survival measured in long-term follow-up extension studies. Our findings suggest that age-based lifetime projections may be used as means to assess the long-term treatment effects.
Project description:PurposeAlthough bone marrow stimulation (BMS) as a treatment for osteochondral lesions of the talus (OCLT) shows high rates of sport resumption at short-term follow-up, it is unclear whether the sports activity is still possible at longer follow-up. The purpose of this study was, therefore, to evaluate sports activity after arthroscopic BMS at long-term follow-up.MethodsSixty patients included in a previously published randomized-controlled trial were analyzed in the present study. All patients had undergone arthroscopic debridement and BMS for OCLT. Return to sports, level, and type were assessed in the first year post-operative and at final follow-up. Secondary outcome measures were assessed by standardized questionnaires with use of numeric rating scales for pain and satisfaction and the Foot and Ankle Outcome Score (FAOS).ResultsThe mean follow-up was 6.4 years (SD ± 1.1 years). The mean level of activity measured with the AAS was 6.2 pre-injury and 3.4 post-injury. It increased to 5.2 at 1 year after surgery and was 5.8 at final follow-up. At final follow-up, 54 patients (90%) participated in 16 different sports. Thirty-three patients (53%) indicated they returned to play sport at their pre-injury level. Twenty patients (33%) were not able to obtain their pre-injury level of sport because of ankle problems and eight other patients (13%) because of other reasons. Mean NRS for pain during rest was 2.7 pre-operative, 1.1 at 1 year, and 1.0 at final follow-up. Mean NRS during activity changed from 7.9 to 3.7 to 4.4, respectively. The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up.ConclusionAt long-term follow-up (mean 6.4 years) after BMS for OCLT, 90% of patients still participate in sports activities, of whom 53% at pre-injury level. The AAS of the patients participating in sports remains similar pre-injury and post-operatively at final follow-up. A decrease over time in clinical outcomes was, however, seen when the follow-up scores at 1 year post-operatively were compared with the final follow-up.Level of evidenceLevel II.
Project description:PURPOSE:To investigate the clinical outcomes after osteochondral allograft transplantation for large Hill-Sachs lesions. METHODS:Patients who underwent osteochondral allograft transplantation for large Hill-Sachs lesions were identified. Clinical assessment consisted of active range of motion (ROM), American Shoulder and Elbow Surgeons score (ASES), Constant-Murley score, Rowe score, and patient satisfaction rate. Radiographic assessment was performed with CT scan. RESULTS:Nineteen patients met the inclusion criteria. The mean age was 21.7 years. The mean preoperative size of the Hill-Sachs lesion was 35.70 ± 3.02%. The mean follow-up was 27.8 months. All grafts achieved union at an average of 3.47 months after surgery. At the final follow-up, graft resorption was observed in 43.1% of patients. The average size of residual humeral head articular arc loss was 12.31 ± 2.79%. Significant improvements (P < .001) were observed for the active ROM, ASES score, Constant-Murley score, and Rowe score. The overall satisfaction rate was 94.7%. No significant difference was found between the resorption group and the nonresorption group in postoperative clinical outcomes. CONCLUSION:Osteochondral allograft transplantation is a useful treatment option for patients with large Hill-Sachs lesions. Although the incidence of graft resorption may be relatively high, the clinical outcomes at a minimum 2-year follow-up are favorable. LEVEL OF EVIDENCE:Level IV, case series.
Project description:BackgroundPeriprosthetic joint infection (PJI) is a significant and challenging complication following total knee arthroplasty (TKA). This study aimed to evaluate the efficacy and safety of treating chronic knee PJI with and without antibiotic-loaded calcium sulfate during two-stage revision surgery.MethodsThis retrospective study analyzed 94 patients with TKA infections who underwent two-stage revision between May 2017 and January 2022 at the First Affiliated Hospital of Zhengzhou University. Key outcomes assessed included infection recurrence rates, postoperative range of motion (ROM), Knee Society Score (KSS), Hospital for Special Surgery (HSS) scores, hematological parameters, and complication rates during the follow-up period.ResultsThe demographic characteristics of the two groups showed no significant differences. The infection control rate was significantly higher in the calcium sulfate group (95.7%) compared to the matched control group (80.9%) (P < 0.05). Both groups demonstrated statistically significant improvements in ROM, HSS, and KSS scores compared to preoperative values (P < 0.05). However, intergroup differences in these outcomes were not statistically significant (P > 0.05). Additionally, there was no significant difference in postoperative complication rates between the two groups.ConclusionThe use of antibiotic-loaded calcium sulfate in two-stage revision surgery for chronic knee PJI ensures sustained local antibiotic release at high concentrations, leading to rapid reduction in inflammatory markers, effective infection control, and a low complication rate. This approach is a safe and effective treatment for chronic knee PJI.
Project description:Cardiac magnetic resonance (CMR) can detect inflammatory myocardial alterations in patients suspected of having acute myocarditis. There is limited information regarding the degree of normalization of CMR parameters during the course of the disease and the time window during which quantitative CMR should be most reasonably implemented for diagnostic work-up. Twenty-four patients with suspected acute myocarditis and 45 control subjects underwent CMR. Initial CMR was performed 2.6±1.9 days after admission. Myocarditis patients underwent CMR follow-up after 2.4±0.6, 5.5±1.3, and 16.2±9.9 weeks. The CMR protocol included assessment of standard Lake Louise criteria, T1 relaxation times, extracellular volume fraction, and T2 relaxation times. Group differences between myocarditis patients and control subjects were highest in the acute stage of the disease (P<0.001 for all parameters). There was a significant and consistent decrease in all inflammatory CMR parameters over the course of the disease (P<0.01 for all parameters). Myocardial T1 and T2 relaxation times-indicative of myocardial edema-were the only single parameters showing significant differences between myocarditis patients and control subjects on 5.5±1.3-week follow-up (T1: 986.5±44.4 ms versus 965.1±28.1 ms, P=0.022; T2: 55.5±3.2 ms versus 52.6±2.6 ms; P=0.001). In patients with acute myocarditis, CMR markers of myocardial inflammation demonstrated a rapid and continuous decrease over several follow-up examinations. CMR diagnosis of myocarditis should therefore be attempted at an early stage of the disease. Myocardial T1 and T2 relaxation times were the only parameters of active inflammation/edema that could discriminate between myocarditis patients and control subjects even at a convalescent stage of the disease.
Project description:BackgroundShort-term follow-up of COVID-19 patients reveals pulmonary dysfunction, myocardial damage and severe psychological distress. Little is known of the burden of these sequelae, and there are no clear recommendations for follow-up of COVID-19 patients.In this multi-disciplinary evaluation, cardiopulmonary function and psychological impairment after hospitalization for COVID-19 are mapped.MethodsWe evaluated patients at our outpatient clinic 6 weeks after discharge. Cardiopulmonary function was measured by echocardiography, 24-hours ECG monitoring and pulmonary function testing. Psychological adjustment was measured using questionnaires and semi-structured clinical interviews. A comparison was made between patients admitted to the general ward and Intensive care unit (ICU), and between patients with a high versus low functional status.FindingsEighty-one patients were included of whom 34 (41%) had been admitted to the ICU. New York Heart Association class II-III was present in 62% of the patients. Left ventricular function was normal in 78% of patients. ICU patients had a lower diffusion capacity (mean difference 12,5% P = 0.01), lower forced expiratory volume in one second and forced vital capacity (mean difference 14.9%; P<0.001; 15.4%; P<0.001; respectively). Risk of depression, anxiety and PTSD were 17%, 5% and 10% respectively and similar for both ICU and non-ICU patients.InterpretationOverall, most patients suffered from functional limitations. Dyspnea on exertion was most frequently reported, possibly related to decreased DLCOc. This could be caused by pulmonary fibrosis, which should be investigated in long-term follow-up. In addition, mechanical ventilation, deconditioning, or pulmonary embolism may play an important role.
Project description:BackgroundOsteochondral lesions of the talus (OLT) is a common and clinically challenging condition with no consensus on the optimal treatment. The prospective case series aim to evaluate the feasibility and clinical outcomes of free autologous costal cartilage transplantation (ACCT) for OLT.MethodsFrom April 2018 to October 2022, three patients who were diagnosed with OLT underwent free ACCT. Demographic characteristics, including age, gender, lesion size and location were collected at baseline. Functional and imaging outcomes were evaluated at 1 year, 2 years, and 5 years postoperatively. The primary outcomes were American Orthopedic Foot and Ankle Society (AOFAS) score and Foot and Ankle Ability Measure (FAAM) score. Secondary outcomes included Numeric Rating Scale (NRS), Tegner Activity Scale, and evaluations of images. A paired t-test was used for preoperative and postoperative comparison of the paired-design dataset.ResultsThree patients (37.33 ± 16.50 years old) were included in the study with 2-5 years follow-up. AOFAS score improved from 60 ± 11 at baseline to 96 ± 6.93 at 2 years (p < 0.01) and 94 ± 8.49 at 5 years. FAAM/ADL improved from 60.97 ± 6.58 at baseline to 98 ± 1.83 at 2 years (p < 0.01) and 97 ± 0.85 at 5 years. FAAM/Sports improved from 56.4 ± 11.95 at baseline to 88.23 ± 11.34 at 2 years (p < 0.01) and 89 ± 4.67 at 5 years. Other functional scores in patient reported outcomes also showed significant improvements. Postoperative CT and MRI showed complete defect filling and robust tissue integration after ACCT. Arthroscopic evaluations further confirmed solid integration of costal cartilage into the underlying subchondral bone with a smooth surface over the repair site.ConclusionFree ACCT is a feasible method for improving ankle function and quality of life for at least 2 years in patients with OLT. Promising long-term outcomes may be possible because of the good integration between the recipient talus and the implanted ACCT.
Project description:IntroductionData on the evolution of gastric precancerous lesions (GPL), especially in countries of a Low gastric cancer incidence area are limited. Our objective was to study a long-term evolution of GPL in France.MethodsAll the patients diagnosed with GPL (atrophic gastritis, intestinal metaplasia [IM], and dysplasia) between 2000 and 2015 and fulfilling criteria for evolution assessment (at least 2 endoscopies, minimal follow-up of 6 months, and at least 2 biopsies obtained from the antrum and corpus) were included. Clinical and endoscopic data were analyzed, and histological samples were reviewed by an expert pathologist with evaluation of the Operative Link on Gastric Intestinal Metaplasia Assessment stage and type of IM.ResultsFrom the 507 patients with GPL, 79 fulfilled the strict criteria. During a mean follow-up of 66 months, during which the patients had a mean number of 4 endoscopies (min-max: 2-21) with 9 biopsies/endoscopy, a stability was observed in 70% of patients. Progression occurred in 14% of patients, within a mean delay of 62.1 months (min-max: 17-99). Progression of the lesions was significantly higher in patients with incomplete type of IM (relative risk of progression for incomplete IM: 11.5; 95% confidence interval 2.5-53.1). Regression of IM occurred in 16% of the patients, after a mean delay of 90 months.DiscussionThis study shows that the patients with antrum-limited IM, especially of incomplete type, are at the highest risk of developing gastric cancer. In most patients, however, the lesions remain stable, which highlights the need for additional markers to better target the patients at risk of progression.
Project description:ObjectiveWe describe the feasibility and short-term outcome of our surgical technique to repair the lymph vessel disruption directly after axillary lymph node dissection during breast cancer surgery. This procedure is called immediate lymphatic reconstruction to prevent breast cancer treatment-related lymphedema (BCRL), which frequently occurs after axillary lymph node dissection. The surgical technique consisted of lymphaticovenous anastomosis (LVA) or lymphaticolymphatic anastomosis. We named the procedure lymphatic bypass supermicrosurgery (LBS).MethodsThis study used a retrospective cohort design of patients with breast cancer between May 2020 and February 2023. LBS was performed by making an intima-to-intima coaptation between afferent lymph vessels and the recipient's veins (LVA) or efferent lymph vessels lymphaticolymphatic anastomosis.ResultsA total of 82 patients underwent lymphatic bypass. The mean age of patients was 50 ± 12 years, and most had stage III breast cancer (n = 59 [72%]). LVA was the most common type of lymphatic bypass (94.6%). The median number of LVA was 1 (range, 1-4) and 1 (range, 1-3) for lymphaticolymphatic anastomosis. The median follow-up time was 12.5 months (range, 1-33 months). The 50 patients who had postoperative indocyanine green lymphography described arm dermal backflow stage 0 in 20 (40%), stage 1 in 19 (38%), stage 2 in 2 (4%), and stage 3 in 9 (18%) cases. The proportion of BCRL was 11 (22%), and subclinical lymphedema was 19 (38%) in this period. Most cases were in stable subclinical lymphedema (10, 58.8%). The 1-year and 2-year BCRL rates were 14% (95% confidence interval, 4%-23.9%) and 22% (95% confidence interval, 10.1%-33.9%), respectively.ConclusionsAlong with the emerging immediate lymphatic reconstruction, LBS is a feasible supermicrosurgery technique that may have a potential role in BCRL prevention. A randomized controlled study would confirm the effectiveness of the technique.