Kaplan-Meier Survival Estimates Research Articles

Left Anterior Descending Coronary Artery Radiation Dose Association with All-Cause Mortality in NRG Oncology Trial RTOG 0617

Left Anterior Descending Coronary Artery Radiation Dose Association with All-Cause Mortality in NRG Oncology Trial RTOG 0617

Cancer should not contravene the revascularization of chronic limb-threatening ischaemia.

This study aimed to examine the frequency of cancer among patients with chronic limb-threatening ischaemia (CLTI) due to peripheral artery disease (PAD) and to determine how active cancer affected outcomes after open or endovascular revascularization. In addition, we aimed to investigate all-cause mortality and cause of death in the PAD population. Observational single-centre cohort study based on a retrospective analysis of prospectively entered registry data. All consecutive patients treated for CLTI due to PAD at a single university centre between the 1st of January 2011 and the 31st of December 2015 were included. Data from the Danish Vascular Registry (Karbase) regarding demographics, surgical procedure, and complications were linked with data from the Danish Cancer Registry and Cause of Death Registry. The primary endpoint was major amputation-free survival. Secondary endpoints were postoperative complications within 30 days, cancer-free survival, all-cause mortality and cause of death in the cohort. Major amputation-free survival, cancer-free survival and mortality were described with Kaplan-Meier (KM) survival estimates. We included 920 patients, of which 116 (13%) were in the active cancer group at the time of revascularization. There was no difference in amputation-free survival between those with cancer (86.8% 1-year KM estimate) and those without cancer (85.2% 1-year KM estimate) (p = 0.50). Likewise, we found no difference in 30-day postoperative complication rate. The risk of developing cancer in the included CLTI cohort was similar to the age-matched background population (6.1% vs 6.4%) (p = 0.69). All-cause mortality was higher in CLTI patients with cancer, mainly due to cancer, compared with CLTI patients without cancer who mainly died from cardiovascular disease. Three-year KM survival estimates were 48.3% (95% CI 40.0%-58.3%) and 64.4% (95% CI 61.2%-67.8%) (p = 0.014) for cancer and non-cancer patients, respectively. Although cancer in patients with CLTI is related to higher medium- to long-term mortality, active cancer per se should not contravene revascularization, as postoperative complications and risk of amputation are not overrepresented.

Postoperative Radiotherapy for Completely Resected Thymoma: What Can We Learn in the Precision Radiation Era?

<h3>Purpose/Objective(s)</h3> The optimal role of radiotherapy (PORT) after complete thymectomy for thymoma remains controversial. We investigate the role of postoperative radiotherapy in the complete resection of Masaoka-Koga stage Ⅱ/Ⅲ thymoma with precision radiotherapy techniques. <h3>Materials/Methods</h3> From January 2000 to December 2017, patients with Masaoka-Koga stage Ⅱ/Ⅲ thymoma who underwent complete resection or complete surgical resection and underwent radiotherapy with precision techniques were included and analyzed. Clinical, pathological, therapeutic and follow-up information was collected. Kaplan-Meier estimates of overall survival (OS), disease-specific survival (DSS) and disease-free survival (DFS), and univariate and multivariate Cox proportional hazards regression analyses were performed. <h3>Results</h3> A total of 244 patients met the selection criteria, 142 (58.1%) of whom were received PORT. Of these, 172 (70.5%) patients with stage Ⅱ thymoma, 72 patients (29.5%) with stage Ⅲ. The median follow-up was 76 months. The 5-year and 10-year OS in the surgical and PORT groups were 93.8% vs 95.4% and 83.6% vs 86.9%, respectively (p=0.34), while the DSS was 93.8% vs 99.0% and 86.3% vs 93.9%, respectively (p=0.038), and the DFS was 85.0% vs 76.9% and 75.9% vs 65.5%, respectively (p=0.65). In stage Ⅲ patients,5-year and 10-year OS was 83.0% vs 95.8%, 54.4% vs 84.4% (HR 0.31, p=0.038) and DSS was 83.0% vs 97.6%, 54.4% vs 91.8% (HR 0.14, p=0.002) for surgery alone vs the PORT group. On multivariate analysis, stage Ⅲ was associated with poorer OS (HR 2.36, <i>p</i>=0.045) and DSS (HR 3.61, <i>p</i>=0.020), and PORT were associated with better DSS (HR=0.26, <i>p</i>=0.012). <h3>Conclusion</h3> Masaoka-Koga stage Ⅱ/Ⅲ thymoma complete resection after radiotherapy with precision radiotherapy techniques resulted in improved DSS but not significant improvement in OS and DFS; Subgroup analysis showed a more pronounced benefit of PORT in stage Ⅲ patients, with benefits in DSS and OS, suggesting that postoperative radiotherapy can be beneficial in more advanced thymoma.

Simultaneous Integrated Boost Technique for Pediatric High-Grade Gliomas: A Single-Institution Experience

<h3>Purpose/Objective(s)</h3> The prognosis for pediatric patients with high grade glioma (HGG) remains dismal despite aggressive multidisciplinary treatment, and there is marked variability regarding the optimal radiation approach. We report outcomes from a retrospective review of pediatric patients with HGG treated using a simultaneous integrated boost (SIB) technique at a single institution. <h3>Materials/Methods</h3> The medical records of patients ages 0–22y with biopsy-proven non-DIPG localized HGG treated with radiotherapy (RT) from January 2006 to May 2021 were retrospectively reviewed on an IRB approved protocol. Endpoints were Kaplan-Meier estimates of overall survival (OS) and progression free survival (PFS), and patterns of failure. <h3>Results</h3> There were 32 patients in the cohort; 24 patients had glioblastoma without further molecular characterization, 2 had H3 K27M mutant diffuse midline gliomas, 2 had G34R mutant glioma, 2 had glioblastoma with IDH1 mutation, 1 had high-grade astrocytoma, and 1 had high-grade glial neoplasm. Median age at diagnosis was 14.9 (1.9–21.5) years. Prior to RT, 6 patients obtained both spinal MRIs and lumbar punctures, 5 obtained spinal MRIs, and 1 had a lumbar puncture; none had evidence of distant metastases. All patients were treated with intensity modulated radiotherapy (IMRT) using SIB with two dose levels. The most common (n=25) dose to the high dose volume was 60 Gy (range, 40–60 Gy); the most common (n=24) dose to the low dose volume was 50 Gy (range, 30–55 Gy). Treatment was most commonly (n=26) delivered in 30 fractions (range, 15-33). One patient did not complete planned RT due to tumor hemorrhage. Median follow up for all patients was 17 (0–164.4) months. For patients who completed planned RT, median PFS was 20.1 (1–140) months from RT start. Median OS was 25.9 months with one- and two-year survival rates of 80% and 56%, respectively. Of 19 patients with known recurrence, 8 recurred locally, 7 recurred in the distant brain, and 4 developed leptomeningeal dissemination. Three patients were alive at 10 years after initial diagnosis; none of these patients were known to have tumors with IDH mutations. <h3>Conclusion</h3> This study explores outcomes in a cohort of pediatric HGG patients treated with SIB technique, with encouraging initial results. Future efforts will be necessary to identify additional molecular and treatment factors that impact outcome.

Treatment outcomes in recurrent versus de novo metastatic pancreatic adenocarcinoma: a real world study

BackgroundA majority of patients undergoing curative intent surgery for pancreatic ductal adenocarcinoma (PDAC) will unfortunately develop recurrent disease. Treatment outcomes for patients with metastatic disease remain suboptimal. In this study, we evaluated clinical outcomes of patients with recurrent PDAC who received systemic therapy and compared outcomes to patients with de novo metastatic PDAC undergoing systemic therapy.MethodsPatients diagnosed with metastatic PDAC between 2014 and 2019 were included using a real-world database. Patients were characterized as either de novo or recurrent based on the date of metastatic diagnosis and history of surgical resection. Overall survival (OS) was summarized within groups via Kaplan–Meier survival estimates and compared using Cox proportional hazards models.ResultsWe included 5170 patients with metastatic PDAC, of which 1101 (21.3%) were classified as having recurrent disease. Median OS for the recurrent group was significantly greater at 10.8 m (95% CI 9.9–11.7) than in the de novo group at 7.3 m (95% CI 7.0–7.7, p < 0.001). We did not observe a significant difference in OS based on when patients recurred after surgery: 10.0 m (95% CI 8.7–11) within six months of surgery versus 11.6 m (95% CI 10–12, p = 0.256) greater than six months from surgery.ConclusionsThese data support the inclusion of patients with recurrent PDAC in clinical trials for advanced disease, including those who develop recurrent disease within six months of surgery. Due to observed differences in survival, randomization should be stratified by disease presentation (recurrent vs de novo).

Repeat Transurethral Resection of Muscle-invasive Bladder Cancer Prior to Radical Cystectomy is Prognostic but Not Therapeutic.

We sought to evaluate the impact of repeat transurethral resection of bladder tumor prior to radical cystectomy on oncologic outcomes in a contemporary cohort at a tertiary care center. An Institutional Review Board approved review of 657 patients diagnosed with muscle-invasive bladder cancer who underwent radical cystectomy at our institution for clinical stage T2 urothelial carcinoma between 2005 and 2017 was performed. Patients with and without repeat transurethral resection of bladder tumor were matched 1-to-1 by propensity score. Matching was done by age, gender, receipt of neoadjuvant chemotherapy, preoperative hydronephrosis, variant histology, lymphovascular invasion, or carcinoma in situ on index transurethral resection of bladder tumor. A total of 548 patients with muscle-invasive bladder cancer were included after matching (2 groups of 274 patients). Kaplan-Meier estimates of recurrence-free and overall survival demonstrated no significant difference based upon performance of repeat transurethral resection of bladder tumor (P = 1.0 and P = .3, respectively). When outcomes were stratified by pathology of repeat transurethral resection of bladder tumor specimens, those with pT0 had superior recurrence-free and overall survival compared to those with residual muscle invasive disease (P < .001 and P = .001, respectively). Notably, more than 60% of patients who were pT0 on repeat transurethral resection of bladder tumor had residual disease at the time of radical cystectomy. Repeat transurethral resection of bladder tumor prior to radical cystectomy, irrespective of receipt of neoadjuvant chemotherapy, was not associated with improved survival outcomes in this propensity score matched muscle-invasive bladder cancer cohort. The absence of residual tumor on pathological evaluation of repeat transurethral resection of bladder tumor specimen was prognostic and was associated with improved survival outcomes. However, a large percentage of patients with pT0 disease on repeat transurethral resection of bladder tumor had residual disease on radical cystectomy pathology.

Clinical outcomes of single crown and 3-unit bi-layered zirconia-based fixed dental prostheses: An upto 6- year retrospective clinical study: Clinical outcomes of zirconia FDPs

ObjectivesThe aim of this retrospective clinical study was to evaluate the survival and the occurrence of technical and biological complications in bi-layered zirconia-based (Zi) single crown and 3-unit fixed dental prostheses (FDPs). Also, the study aimed to analyze the effects of tooth vitality (vital versus non-vital), abutment location (anterior versus posterior), and luting cement (self-adhesive resin versus resin-reinforced glass ionomer) on clinical outcomes. MethodsA total of 147 prostheses (in 94 patients) placed by undergraduate dental students in a university dental center during the period 2015–2021 were examined clinically using modified United States Public Health Service (USPHS) and California Dental Association (CDA) criteria. The mean duration of follow-up was 37 months (range, 6 - 63 months) for the single crowns (n = 77) and 25 months (range, 6 - 68 months) for the 3-unit FDPs (n = 70). Data were descriptively analyzed to determine the types and rates of complications based on USPHS and CDA criteria. The Kaplan-Meier survival estimation method was used to determine the cumulative survival and success rates of the prostheses (α=0.05). Differences in clinical outcomes (survival or failure) according to tooth vitality, luting cement, and location were statistically analyzed using cross-tabulations and Х2 test (α=0.05). ResultsThe Kaplan-Meier cumulative survival rate was estimated as 96% for the Zi 3-unit FDPs after 5.5 years, and 90% for the Zi single crowns after 4.8 years. The 5-year estimated success rate was 68% for both 3-unit FDPs and single crowns. Seven (9.1%) 77Zi single crowns and 70 2 (2.9%) Zi 3-unit FDPs were recorded as failures with occlusal roughness being the most commonly-observed complication (crowns: 4 [5.6%]; 3-unit FDPs: 8 [11.4%]). In terms of clinical outcomes, statistically significant differences were found between all included vital and non-vital teeth (p = .006), and cement types (p = .028). Taking single crowns alone, significant differences in clinical outcomes according to tooth vitality were noted (p = .036), but not for PFDPs. The location of the prostheses did not produce any significant differences in the clinical outcomes, for both prostheses types independently or combined (p > .05). ConclusionsThe estimated cumulative survival rates in this study for single crowns and 3-unit Zi FDPs concurred with the ranges reported in systematic reviews. Zi-based prostheses on vital teeth produced better clinical outcomes than those placed on non-vital teeth, and type of luting cement influenced the final clinical outcome. Clinical significanceZi crowns and 3-unit PFDPs fabricated using the specific CAD-CAM system used in the controlled environment of this study showed good clinical performance with minimal veneer porcelain chipping. Root canal treated teeth seem to be at higher risk for failure of Zi prostheses compared with vital teeth.

Patient survival after surgical resection of pelvic bone sarcomas: A nationwide cohort study

Background: Pelvic bone sarcomas are extremely rare malignant tumours. Patients require a multidisciplinary approach to plan the treatment and complex surgical resections and limb-sparing reconstructions associated with complications, revisions, and functional limitations. The presented nationwide study in the Republic of Slovenia aims to analyse the oncological survival and functional outcomes of patients after primary resection of pelvic bone sarcomas.&#x0D; Methods: The retrospective observational cohort included 21 consecutive patients who underwent limb-sparing pelvic resection at a specialized orthopaedic oncology centre in the Republic of Slovenia between 2004-2022. Patient survival, complication rates, and functional outcomes were analysed according to to the primary diagnosis.&#x0D; Results: Wide margins with R0 resection were achieved in 16 (76%) cases. After a median follow-up of 5.7 (0.6-18.1) years, 7 (33%) patients died of oncological disease, 3 (14%) patients were alive with oncological disease, and 11 (53%) patients were alive with no evidence of disease. The estimated Kaplan-Meier survival probability at 2 years, 5 years, and 10 years after pelvic resection was 85%, 73%, and 45%, respectively. The major complication rate was 29%. The mean Musculoskeletal Tumour Society Score was 17.5 (range 2-29).&#x0D; Conclusions: Patient survival after resection of pelvic bone sarcomas in Slovenia between 2004-2022 is comparable to previously published reports of European and North American countries. Wide resection of tumours with reconstruction provides a relatively good survival rate, although complications are common and functional outcomes are often poor.

Mortality patterns among patients with restrictive cardiomyopathy referred for CMR in a tertiary care center in Latin-America

Abstract Background Restrictive Cardiomyopathies (R-CMP) represent a wide array of conditions characterized by diastolic heart failure with important impairment in left ventricle filling pressures. These entities require different treatments, rendering etiological diagnosis a key component during the evaluation of these patients. Purpose Report the mortality of a select group of patients with R-CMP referred to CMR in a tertiary care center in Latin-America. Methods We analyzed all patients with CMR performed in our institution, including hospitalized and ambulatory patients, between 2016 and 2021. We extracted data of patients diagnosed by CMR with amyloidosis, hypertrophic cardiomyopathy (HCM), and endomyocardial fibrosis (EMF). All-cause mortality was extracted from national census data and analyzed using Kaplan-Meier survival estimates and log-rank test. Results Between June 1st, 2016, and December 31st, 2021, 5000 CMRs were performed at our institution. Among these, 317 (6.3%) patients were diagnosed with R-CMP by CMR as follows: 52 patients (16.4%) had amyloidosis, 250 patients had HCM (78.9%) and 15 patients (4.7%) had EMF. Of these, 40.7% were female (n=129), the median age was 63 yar-old (IQR 51–71) and 64.7% (n=205) were out-patients. At a mean follow-up of 33.3 months, there was a statistically significant difference in mortality between patients with amyloidosis (49,0%) and those with HCM and EMF (7,1% and 13,3%, respectively; P&amp;lt;0.001), as described in Figure 1. Conclusions R-CMP represent a meaningful percentage of patients referred for CMR in our institution with different survival rates. Amyloidosis patients had a significantly higher mortality rate compared to HCM and EMF, at a relatively short follow-up. Increased access to CMR in our region for optimal diagnosis and early treatment may optimize prognosis in these types of patients. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Self funding

Sex-based outcomes after surgery for acute type A aortic dissection.

While prior data have suggested worse outcomes in women after acute type A aortic dissection (ATAAD) repair when compared to men, results have been inconsistent across studies over time. This study sought to evaluate the impact of sex on short- and long-term outcomes after ATAAD repair. This was a retrospective study utilizing an institutional database of ATAAD repairs from 2007 to 2021. Patients were stratified according to sex. Kaplan-Meier survival estimation and multivariable Cox regression were performed. Supplementary analysis using propensity score matching was also performed. Of the 601 patients who underwent ATAAD repair, 361 were males (60.1%) and 240 (39.9%) were females. Females were significantly older, more likely to have hypertension, and more likely to have chronic lung disease. Females were also significantly more likely than males to undergo hemiarch replacement, while males were significantly more likely than females to undergo total arch replacement and frozen elephant trunk. Operative mortality was 9.4% among males and 13.8% among females, though this was not a statistically significant difference (p = .098). Postoperative complications were comparable between groups. Kaplan-Meier survival estimates were similar for men and women, and, on multivariable Cox regression, sex was not significantly associated with long-term survival (hazard ratio: 1.00, 95% confidence interval: 0.73, 1.37, p = .986). Outcomes remained comparable after supplementary propensity score matched analysis. ATAAD repair can be performed with comparable short-term and long-term outcomes in both men and women.

1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study.

Tricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative. The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences). Patients with≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events. The 37 patients enrolled had a mean age of 78 years; 76% were female; and they had≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved≤ moderate TR (P< 0.0001), and 73.1% had≥2 grade reductions. Echocardiography showedsignificant reductions in the tricuspid annulus diameter (P< 0.0001), mean vena contracta (P< 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P< 0.0001), right ventricular end-diastolic diameter (P< 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P< 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P< 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively. One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes.

S1620 Association of Insurance Status with Survival and Disease Stage at Presentation of Gastric Cancer: A National Cancer Database Analysis

Introduction: In the US, 9.6% of the population (31 million people) do not have health insurance. Uninsured patients with cancer are more likely to present with advanced disease, not receive equal treatment, and display worse survival than those with insurance. Gastric cancer is one of the leading causes of death worldwide, and curative treatment depends on the disease stage at the time of diagnosis. The purpose of this study is to determine the association of insurance status with disease stage at presentation and survival among patients diagnosed with gastric cancer using the National Cancer Database (NCDB). Methods: The analysis cohort included gastric cancer patients in the NCDB diagnosed from 2010 to 2015. Patients were excluded if no information was available regarding insurance status or cancer staging at the time of diagnosis. Multivariable logistic regression models were used to determine the association between insurance status and gastric cancer stage at diagnosis/presentation. Cox regression models were used to determine the association between insurance status and all-cause mortality. Results: Following exclusions, 178,641 patients had gastric cancer during the study period. 171,199 patients (95.8%) had insurance in comparison to 7,442 patients (4.2%) who were uninsured. Univariate analysis between the groups demonstrated a statistically significant higher proportion of poor differentiation (53.2%), advanced disease (46.2%), and metastasis (41.9%) at diagnosis in the uninsured group (Table). After adjusting for demographic and socioeconomic variables, being insured was the main predictor for not having metastatic disease at diagnosis (OR = 0.60 [95% CI, 0.57-0.63]). Median time to all-cause mortality was estimated at 45 months for uninsured patients vs 60 months for insured patients (Figure). Conclusion: There is an association between insurance status and disease stage at time of diagnosis for patients with gastric cancer. Patients without insurance present with advanced disease and have a lower survival rate compared to insured patients. Lack of insurance compromises a person’s health because they are less likely to receive preventive care, are less able to afford prescription drugs, are more likely to be hospitalized for avoidable health problems, are more likely to be diagnosed in the late stages of disease, and once diagnosed tend to receive less therapeutic care.Figure 1.: a. Predictors of non-metastatic vs metastatic disease b. Kaplan-Meier Survival Estimates. Table 1. - Tumor Characteristics Insured (n= 171,199) Uninsured (n= 7,442) P-value Tumor size, mean (standard deviation), cm 4.42 +/- 4.6 5.50 +/- 4.7 < 0.001 Differentiation grade, No. (%) < 0.001 Well differentiated 12,244 (7.15) 384 (5.16) Moderately differentiated 36,394 (21.26) 1,230 (16.53) Poorly differentiated 78,541 (45.88) 3,960 (53.21) Undifferentiated, anaplastic 3,076 (1.80) 114 (1.53) Cell type not determined 40,944 (23.92) 1,754 (23.57) Tumor Stage at diagnosis, No. (%) < 0.001 Stage 0 3,081 (1.80) 40 (0.54) Stage I 35,769 (20.89) 852 (11.45) Stage II 21,970 (12.83) 723 (9.72) Stage III 27,921 (16.31) 1,159 (15.57) Stage IV 51,726 (30.21) 3,436 (46.17) Not applicable 5,066 (2.96) 205 (2.75) Unknown 25,666 (14.99) 1,027 (13.80) Metastatic disease, No. (%) < 0.001 No 115,122 (70.82) 3,815 (55.10) Yes 42,370 (26.07) 2,906 (41.97) Not Applicable 5,058 (3.11) 203 (2.93)

Assessment of the Efficacy of an Alternative Regimen of Lomustine in Recurrent GBM – A Single Centre Experience

Abstract AIMS Lomustine (CCNU) based regimens are frequently used for recurrent glioblastoma multiforme (GBM). The usual CCNU regimen is 100-130mg/m2, day 1 x 6-weekly cycle for up to 6 cycles. Efficacy is limited, with median progression-free survival (PFS) approximating 1.0-3.0 months with higher haematological toxicities, particularly thrombocytopenia around 13-25%. The Clatterbridge Cancer Centre, UK, has adopted the regimen of 40mg once a day over 4 days x 4-weekly for up to 6 cycles. This study aims to identify the efficacy and toxicity profile of this regimen in recurrent GBM. METHOD A retrospective analysis on 113 recurrent GBM patients, treated with single-agent CCNU as a second-line, between June 2016 and January 2020. Kaplan-Meier survival estimates identified PFS, PFS at 6 months (PFS6) and Overall Survival (OS) using SPSS v.27. Overall Responses were based on imaging or clinical assessment in patients with at least 2 CCNU cycles. SACT assessments and blood test records, using CTCAE v5.0 grading, identified clinical adverse events. RESULTS We observed an 18.8% overall response rate with 2.4% partial response and 16.5% stable disease. There was a CCNU-specific 8-month median OS, 4-month median PFS, and 20.4%% PFS6. This regimen was well-tolerated. The most common toxicity was grade 1 fatigue (38.9%). The Grade 3 or 4 haematological toxicity was low with 12% thrombocytopenia and 2.7% neutropenia rates in patients. CONCLUSION This study suggests a reasonable alternative to the usual regimen, offering improved tolerance, lower toxicity rates, and equivalent efficacy. We propose prospective studies comparing differing CCNU regimens to mitigate retrospective studies’ limitations.

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform

BackgroundComplex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience. MethodsAll patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up. ResultsFrom 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft’s main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively. ConclusionsInner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

Real-world overall survival of patients receiving cetuximab in later lines of treatment for metastatic colorectal cancer.

Aim: To examine characteristics of and treatment duration and real-world overall survival (rwOS) in patients receiving cetuximab as second-line (2L) or third-line (3L) treatment for metastatic colorectal cancer. Materials & methods: This was a retrospective study of 1096 and 684 patients in 2L and 3L cohorts, respectively. Results: The most common cetuximab-based regimens were cetuximab+ folinic acid, fluorouracil and irinotecan (2L: 44%; 3L: 32%) and cetuximab+irinotecan (2L: 28%; 3L: 35%). Kaplan-Meier survival estimates and stepwise Cox regression model analysis demonstrated mediantreatment duration and rwOS of 3.7 and 14.4 months, respectively, in patients receiving treatment in the 2L cohort. In the 3L cohort, treatment duration was 3.3 months and rwOS was 12.0 months. Conclusion: This large real-world study provides evidence of rwOS in patients with metastatic colorectal cancer receiving cetuximab-based regimens as 2L or 3L treatment.

Prognostic variables and 4-year survival outcomes in CD20 Positive AIDS-Related Lymphoma in the Anti-retroviral treatment era: A Retrospective Review from a Single Centre in KwaZulu-Natal, South Africa.

To describe 4-year survival outcomes and assess the value of established and additional relevant variables to predict complete response (CR), four-year progression-free survival (PFS) and overall survival (OS) of CD20 positive AIDS-Related Lymphoma (ARL) treated with standard combination chemotherapy. We performed a retrospective review of patients diagnosed with CD20 positive ARL between 2006 and 2016. All patients over 12 years of age who received at least one cycle of combination chemotherapy with curative intent were included in the analysis. Variables assessed included the International Prognostic Index (IPI), age-adjusted-IPI, age, gender, B symptoms, extent of disease, functional performance status, CD4 cell count, viral load, concurrent ART with chemotherapy, rituximab inclusion, and number of chemotherapy cycles used. Kaplan-Meier survival curves for OS and PFS at 4 years were compared for IPI and aaIPI using the log-rank test. A Cox proportional hazards model was used to investigate the effects of prognostic variables for patients achieving OS and PFS at 4 years and logistic regression for patients achieving CR. A total of 102 patients were included in the analysis. At year four of follow-up, the OS was 50% (n = 51) and PFS was 43% (n = 44). Attaining a CR and male gender were significantly associated with improved 4-year OS (p<0.001 and p = 0.028 respectively) and PFS (p<0.001 and 0.048 respectively). A viral load of < 50 copies/ml was associated with a higher complete response rate (aOR 6.10 [95% CI 1.15, 24.04], p = 0.01). Six or more cycles of chemotherapy was superior to fewer cycles for both PFS (aHR 0.17 [95% CI 0.10, 0.29]) and OS (aHR 0.12 [95% CI 0.07, 0.22]) with p-value < 0.001 for both PFS and OS. The Kaplan-Meier survival estimates demonstrated the prognostic utility of the IPI and aaIP for OS (p = 0.002 and 0.030 respectively) and the IPI for PFS (p = 0.002). This study is a first from a high prevalence HIV area in KwaZulu-Natal, South Africa, and confirms the utility of the internationally accepted prognostic scoring systems in predicting survival in CD20 positive ARL in the local population.

Primary inlay reverse shoulder arthroplasty has a higher rate of revision than onlay reverse shoulder arthroplasty: Analysis from the Australian Orthopaedic Association National Joint Replacement Registry.

Two classes of primary reverse total shoulder arthroplasty (rTSA), inlay (in-rTSA), and onlay (on-rTSA) were compared to determine differences in rates of revision. Between 1 January 2012 and 31 December 2020, all primary in-rTSA or on-rTSA procedures were compared from a large national arthroplasty registry by cumulative percentage revision (CPR). Kaplan-Meier estimates of survivorship and hazard ratios from Cox proportional hazard models adjusted for age, gender, glenosphere size, and humeral fixation determined any associations to the risk of revision. Of the 14,807 in-rTSA and 6590 on-rTSA procedures, the CPR at seven years was 4.9%. There was an increased risk of revision for in-rTSA vs on-rTSA (p = 0.039) when adjusted for age, gender, glenosphere size, and humeral fixation. Glenosphere size <38 mm adjusted for age and gender (p = 0.016) increased the revision risk. Revision for instability/dislocation occurred more often for in-rTSA vs on-rTSA (p < 0.001) in the first three months. Males had a higher rate of revision than females for in-rTSA (3months+, p = 0.001) and for on-rTSA (p < 0.001). Care should be taken when considering in-rTSA particularly in males, and if preoperative planning suggests a small (<38 mm) glenosphere. Level III, therapeutic study. Original article.

Is artificial urinary sphincter surgery safe and effective in elderly males aged 70 years and above?

To evaluate the clinical outcomes and patient satisfaction rate between men aged under and over 70 years who underwent artificial urinary sphincter (AUS) surgery. A prospective review of all men who received AUS between January 2008 and January 2018 was undertaken with a minimum 24-month review. All patient demographics and surgical outcomes including data on the Incontinence Impact Questionnaire, Patient Global Impression of Improvement (PGI-I) and National Surgical Quality Improvement Program Frailty Index (NSQIP-FI) scores, as well as patient satisfaction rates, were recorded. Of the 245 AUS implanted, 60 patients were aged ≥70 years with 45 virgin cases and 15 revision AUS. Reduction in mean pad use and weight over 24 hours were significant at 0.21 (0-1) pads and 8 (0-30) g in both groups with no significant difference (P=0.76). Kaplan-Meier estimates of AUS survival showed no significant difference between men aged ≥ and <70 years at 1 year (98% versus 96%; P=0.44). The multivariate logistic regression model showed that radiation (adjusted odds ratio [OR] 3.8, 95% CI 1.4-6.8; P < 0.01) was a significant predictor of AUS revision, while age ≥ 70 years (adjusted OR 1.0, 95% CI 0.8-8.8; P=0.14) and frailty (NSQIP-FI ≥ 0.27 adjusted OR 0.9, 95% CI 0.2-7.6; P=0.82) were not. There were no significant differences in PGI-I scores (P=0.43) and overall satisfaction rate (83% versus 84%; P=0.44) between the two groups. Men aged ≥70 years reported similar clinical efficacy as men aged <70 years in terms of device survival and satisfaction rates following AUS surgery.

Efficacy and Safety Results of Different Ablation Technologies for Persistent Atrial Fibrillation Treatment.

Pulmonary vein isolation is the primary goal in treating patients with paroxysmal atrial fibrillation using catheter ablation. This study's purpose is a comparative assessment of the efficacy and safety of two strategies for catheter treatment in patients with persistent atrial fibrillation. The study included 127 patients with persistent atrial fibrillation during the last six months before inclusion in the study. The average follow-up period was 24 months. The primary efficacy endpoint (death, cerebrovascular event, or serious complications associated with treatment) occurred in 15 patients in the cryoballoon ablation group and 14 patients in the radiofrequency ablation group. The Kaplan-Meier survival estimates were 30% and 28%, and the risk ratio 0.96 and 95% of the confidence interval. The treatment in patients with persistent atria fibrillation, using catheter ablation with contact force control catheter treatment with the pulmonary vein isolation, was more efficient.

Shoulder arthroplasty in patients with a history of epilepsy is safe and effective

BackgroundThe safety of shoulder arthroplasty for patients with a history of convulsive seizures is unknown. Concerns include the possibility of a postoperative seizure resulting in dislocation, cuff disruption, or implant failure. We sought to compare outcomes and complications following shoulder arthroplasty in patients with and without a history of convulsive seizures. MethodsOur institutional Total Joint Registry Database was queried to identify all patients with a history of convulsive seizures who had undergone a primary shoulder arthroplasty between 2000 and 2018. The query identified 56 shoulders (49 patients) with an average age of 61.8 years. 51.8% of patients were female. This cohort was matched 2:1 to a group of patients with similar surgical and demographic characteristics who did not have a seizure history. Kaplan–Meier estimates and univariate Cox regression models were utilized to compare implant survival and reoperation rates. Patient-reported outcomes, including the American Shoulder and Elbow Surgeons score were also extracted. ResultsAt most recent follow-up, cumulative reoperation rates were equivalent between the groups (P = .9) with 3 reoperations out of 56 shoulders (5.4%) in the seizure group, and 7 reoperations out of 112 shoulders (6.3%) in the nonseizure group. Rates of implant revision were also similar. Five-year Kaplan–Meier survival estimates free of reoperation were 97.8% (95% confidence interval, 91.1-100.0) in the seizure group and 93.1% (95% confidence interval, 87.4-98.9) in the nonseizure group. Postoperatively, 23 of 56 patients in the seizure group had at least 1 known seizure after their index arthroplasty, at an average of 4.4 years after surgery. None of the patients with postoperative seizures sustained a dislocation. Altogether only 3 episodes of prosthetic dislocation were observed, all in the nonseizure group. The only complication attributable to a seizure was an early postoperative seizure resulting in subscapularis failure, although this patient never underwent reoperation. Patient-reported outcomes and range of motion were similar between groups, with average American Shoulder and Elbow Surgeons scores of 77.2 and 74.9 in the seizure and nonseizure groups, respectively (P = .6). DiscussionReoperation rates and implant survival following shoulder arthroplasty were similar when comparing patients with and without a history of convulsive seizures. Postarthroplasty seizures occurred in a notable number of patients but did not result in any major complications. While it remains prudent to ensure that patients’ seizures are well controlled prior to arthroplasty, our data suggest that individuals with a convulsive seizure disorder can undergo shoulder arthroplasty safely.