5-year Freedom Research Articles

Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.

Outcomes of non-flow-limiting spiral dissection after drug-coated balloon angioplasty for de novo femoropopliteal lesions.

Whether drug-coated balloon (DCB) angioplasty would be effective in spiral dissection (SD) lesions with no flow impairment has been thoroughly investigated. The present study sought to assess the clinical outcomes of non-flow-limiting SD after DCB angioplasty for de novo femoropopliteal lesions in patients with symptomatic lower extremity artery disease. This single-center retrospective study enrolled 497 patients with non-flow-limiting SD (n = 92) or non-SD (n = 405) without bailout stenting. The primary endpoint was 1-year primary patency, with the secondary endpoints including freedom from target lesion revascularization (TLR), major adverse limb event (MALE), all-cause death, and 30-day restenosis. The 1-year primary patency and freedom from TLR were significantly lower in the SD group than in the non-SD group (69.8% vs. 83.3%, p = 0.004; 78.7% vs. 93.0%, p = 0.007, respectively). The SD group had a higher incidence of MALE and 30-day restenosis than the non-SD group (24.6% vs. 11.9%, p = 0.001; 4.3% vs. 0.5%, p = 0.002, respectively). All-cause death was comparable. One-year restenosis after SD was associated with chronic limb-threatening ischemia (CLTI) (hazard ratio, 3.36 [95% confidence interval, 1.21-9.36]; p = 0.020), TASC Ⅱ D (hazard ratio, 3.97 [95% confidence interval, 1.02-15.52]; p = 0.047), and residual stenosis ≥50% (hazard ratio, 4.92 [95% confidence interval, 1.01-23.94]; p = 0.048). The incidence of restenosis after SD increased with the number of these risk factors. Despite normal antegrade flow, the 1-year primary patency rate after DCB angioplasty for de novo femoropopliteal lesions was significantly lower in lesions with SD than those without SD. CLTI, TASC II D, and residual stenosis ≥50% were risk factors associated with 1-year restenosis after DCB angioplasty for non-flow-limiting SD lesions.

Midterm outcomes of arteriovenous fistula aneurysm repair with simultaneous inflow revision or outflow tract revascularization

ObjectiveThe aim of this study was to investigate the 2-year outcomes of extensive revisions aimed at simultaneously addressing arteriovenous fistula (AVF) aneurysms, outflow stenosis, and/or high flow volumes. MethodsThis was a retrospective cohort study in a tertiary referral center. The study population comprised hemodialysis patients with aneurysmal AVFs requiring revision. Subjects were eligible if they were ≥18 years of age and had aneurysm repair associated with inflow revision or treatment of outflow lesions. Patients were followed-up for a minimum of 2 years, and the primary outcome measure was cumulative patency. ResultsOur cohort comprised 93 patients with a mean age of 56 ± 12 years. The most frequent access type was brachiocephalic fistula (61%), and the median access age at the time of revision was 66 months (interquartile range, 46-93 months). The median access flow volume was 2300 ml/min (interquartile range, 1281-2900), and 31 subjects (33%) presented aneurysms associated with both high flow and venous obstruction. Aneurysm repair consisted of aneurysmorraphy in the overwhelming majority (95%). Inflow revision was performed in a total of 49 cases (53%), and outflow tract obstruction was treated in 71 patients (72%), with 27 patients (29%) receiving a simultaneous 3-component revision. At 2 years, the primary, primary assisted, and cumulative patencies were 60% ± 1%, 91% ± 3%, and 94% ± 3%, respectively. The most frequent indication for first-time reinterventions was outflow tract stenosis (24%). Aneurysm recurrence was observed in 13 subjects (14%) during the entire follow-up and was responsible for reinterventions in seven of them (8%), with a 2-year freedom from aneurysm-related reintervention rate of 95% ± 3%. ConclusionsExtensive AVF revision with simultaneous aneurysm repair, inflow revision, and outflow tract revascularization is feasible, safe, and associated with favorable 2-year patency rates.

Ross procedure or mechanical aortic valve, which is the best lifetime option for an 18-year-old? A decision analysis

Objective(s)Identifying the optimal solution for young adults requiring aortic valve replacement (AVR) is challenging, given the variety of options and their lifetime complication risks, impacts on quality of life, and costs. Decision analytic techniques make comparisons incorporating these measures. We evaluated lifetime valve-related outcomes of mechanical aortic valve replacement (mAVR) versus the Ross procedure (Ross) using decision tree microsimulations modeling. MethodsTransition probabilities, utilities, and costs derived from published reports were entered into a Markov model decision tree to explore progression between health states for hypothetical 18-year-old patients. In total, 20,000 Monte Carlo microsimulations were performed to model mortality, quality-adjusted-life-years (QALYs), and health care costs. The incremental cost-effectiveness ratio (ICER) was calculated. Sensitivity analyses was performed to identify transition probabilities at which the preferred strategy switched from baseline. ResultsFrom modeling, average 20-year mortality was 16.3% and 23.2% for Ross and mAVR, respectively. Average 20-year freedom from stroke and major bleeding was 98.6% and 94.6% for Ross, and 90.0% and 82.2% for mAVR, respectively. Average individual lifetime (60 postoperative years) utility (28.3 vs 23.5 QALYs) and cost ($54,233 vs $507,240) favored Ross over mAVR. The average ICER demonstrated that each QALY would cost $95,345 more for mAVR. Sensitivity analysis revealed late annual probabilities of autograft/left ventricular outflow tract disease and homograft/right ventricular outflow tract disease after Ross, and late death after mAVR, to be important ICER determinants. ConclusionsOur modeling suggests that Ross is preferred to mAVR, with superior freedom from valve-related morbidity and mortality, and improved cost-utility for young adults requiring aortic valve surgery.

BIOM-55. TARGETED GENE EXPRESSION PROFILING PREDICTS MENINGIOMA OUTCOMES AND RADIOTHERAPY RESPONSES

Abstract INTRODUCTION Improvements in meningioma risk stratification are needed and current indications for postoperative radiotherapy are controversial. Here we report multicenter clinical and analytical validation of a gene expression biomarker using clinical and genomic data from 1856 meningiomas from 12 institutions across 3 continents. METHODS A previously-developed 34-gene expression biomarker was applied to 3 validation cohorts: (1) a multicenter retrospective clinical validation cohort (N = 6 centers, N = 866 meningiomas, median follow-up 5.2 years), (2) a prospective investigator-blinded clinical validation cohort from RTOG 0539 (N = 103 meningiomas, median follow-up 8.4 years), and (3) an analytical validation cohort for test/re-test and FFPE/frozen analyses, and comparison across platforms for gene expression quantification (N = 8 centers, N = 1219 meningiomas). Biomarker performance was compared to 9 other meningioma classification systems. Favorable versus unfavorable cases were defined as (1) gene expression low risk with any resection, or gene expression intermediate risk with GTR (favorable), versus (2) gene expression intermediate risk with STR, or gene expression high risk with any resection (unfavorable). RESULTS The biomarker improved on WHO 2021 grade (5-year local freedom from recurrence [LFFR] delta-AUC 0.11, 95% CI 0.07-0.17, p< 0.001) and all other classification systems for LFFR and OS on multivariate analysis, achieving a negative predictive value for recurrence at 5-years of 91.9%. The biomarker predicted LFFR after postoperative radiotherapy, with a hazard ratio of 0.33 for unfavorable primary WHO grade 2 meningiomas (95% CI 0.14-0.76, P = 0.009), and 0.54 for unfavorable propensity-matched meningiomas across all WHO grades (95% CI 0.37-0.78, p = 0.0001). The biomarker reclassified 39.8% of meningiomas from RTOG 0539, including downstaging 30.5% of patients who received postoperative radiotherapy, and was independently prognostic for overall survival on multivariate analysis. CONCLUSIONS A 34-gene expression biomarker improves prognostication of meningioma outcomes and predicts postoperative radiotherapy responses.

Posttreatment Surveillance Imaging After Radiation for Head and Neck Cancer

The role of surveillance imaging after treatment for head and neck cancer is controversial and evidence to support decision-making is limited. To determine the use of surveillance imaging in asymptomatic patients with head and neck cancer in remission after completion of chemoradiation. This was a retrospective, comparative effectiveness research review of adult patients who had achieved a complete metabolic response to initial treatment for head and neck cancer as defined by having an unequivocally negative positron emission tomography (PET) scan using the PET response criteria in solid tumors (PERCIST) scale within the first 6 months of completing therapy. The medical records of 501 consecutive patients who completed definitive radiation therapy (with or without chemotherapy) for newly diagnosed squamous cell carcinoma of the head and neck between January 2014 and June 2022 were reviewed. Surveillance imaging was defined as the acquisition of a PET with computed tomography (CT), magnetic resonance imaging (MRI), or CT of the head and neck region in the absence of any clinically suspicious symptoms and/or examination findings. For remaining patients, subsequent surveillance after the achievement of a complete metabolic response to initial therapy was performed on an observational basis in the setting of routine follow-up using history-taking and physical examination, including endoscopy. This expectant approach led to imaging only in the presence of clinically suspicious symptoms and/or physical examination findings. Local-regional control, overall survival, and progression-free survival based on assignment to either the surveillance imaging or expectant management cohort. This study included 340 patients (mean [SD] age, 59 [10] years; 201 males [59%]; 88 Latino patients [26%]; 145 White patients [43%]) who achieved a complete metabolic response during this period. There was no difference in 3-year local-regional control, overall survival, progression-free survival, or freedom from distant metastasis between patients treated with surveillance imaging vs those treated expectantly. In this comparative effectiveness research, imaging-based surveillance failed to improve outcomes compared with expectant management for patients who were seemingly in remission after completion of primary radiation therapy for head and neck cancer.

Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis

Abstract Background Hemodialysis (HD) patients, who are at high risk for atherosclerosis including peripheral artery disease, are associated with poor clinical outcomes after endovascular therapy. Although recent clinical trials have reported favorable outcomes after drug-coated balloon (DCB) treatment for femoropopliteal lesions, its usefulness and risk factors in HD patients have not been well elucidated. Purpose This study aimed to investigate clinical outcomes and the associated risk factors after DCB treatment in HD patients with femoropopliteal lesions. Methods This study included 140 HD patients with their 185 femoropopliteal lesions that underwent DCB treatment between September 2018 and January 2022. Non-HD patients and cases of acute limb ischemia were excluded. The endpoints were 1-year freedom from restenosis and clinically driven target lesion revascularization (CD-TLR). The risk factors were also evaluated. Result Duration of maintenance hemodialysis in all patients was 8.6 years. Mean lesion length was 11.0±6.9 cm, and rates of chronic total occlusion and severe calcification were 17.3% and 45.4%, respectively. Types of DCB were IN.PACT Admiral (22.9%), Lutonix (50.8%) and Ranger (24.3%). Bail-out stenting was performed in 1.1% of all lesions. The Kaplan-Meier estimate of freedom from restenosis and CD-TLR were 63.8% and 71.3% at 12 months, respectively. The freedom rates from CD-TLR after high-dose and low-dose DCB therapy were 79.4% and 66.4%, respectively (p=0.095). Risk factors independently associated with 1-year CD-TLR were diabetes [hazard ratio (HR) 2.30, 95% confidence interval (CI) 1.03-5.15, p=0.043], chronic limb-threatening ischemia (HR 1.93, 95%CI 1.05-3.53, p=0.035) and sever calcification (HR 2.42, 95%CI 1.39-4.21, p=0.0019). When patients were divided into groups according to number of these three risk factors, the rates of freedom from CD-TLR at 12 months were 100%, 94.8%, 76.7% and 30.3% among groups with no risk factor, any 1 risk factor, any 2 risk factors and all risk factors, respectively (p<0.0001). Conclusion The 1-year clinical outcomes after DCB treatment in HD patients with femoropopliteal lesions were unsatisfactory. Independent risk factors for 1-year CD-TLR were diabetes, chronic limb-threatening ischemia and severe calcification.

Abstract 13699: Comparing Patency Benefits of Pulmonary Stent Implantation and Balloon Angioplasty in Pulmonary Vein Stenosis: A Systematic Review and Meta-Analysis

Introduction: Pulmonary vein stenosis (PVS) may arise from various conditions and result in significant morbidity and mortality. Transcatheter approaches, including pulmonary stent implantation (PSI) and pulmonary balloon angioplasty (PBA) are associated with restenosis risks. We conducted a meta-analysis comparing PSI and PBA to understand restenosis risk and complications rate. Methods: We conducted a comprehensive search of PubMed, Google Scholar, Scopus, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases from inception until May 2023. A total of 1233 studies were screened, and 11 studies were included in our analysis. Our primary outcomes of interest were the risk of restenosis requiring reintervention, 5-year freedom from restenosis, and the risk of procedure-related complications. We calculated odds ratios (ORs) with corresponding 95% confidence intervals (CIs) using a random-effects model and performed a meta-regression analysis. Results: We included a total of eleven observational studies in our meta-analysis, comprising 780 patients with PVS, 335 of whom underwent PBA and 445 underwent PSI. Our analysis showed that PSI was associated with a lower risk of restenosis requiring reintervention compared to PBA (OR 0.34, 95% CI 0.13, 0.87, P= 0.02). PSI was also associated with a significantly higher 5-year freedom from restenosis (OR 4.42, 95% CI 1.11, 17.62, P= 0.04) than PBA. There was no significant difference in the risk of procedure-related complications between PSI and PBA. Our meta-regression analysis revealed that age of patient and stent size did not significantly affect the risk of restenosis requiring intervention. Conclusions: PSI offers superior patency benefits compared to PBA for PVS. PSI was associated with a lower risk of restenosis requiring reintervention and a higher 5-year freedom from restenosis. Bases on these findings, PSI is the preferred strategy for the treatment of pulmonary vein stenosis.

Abstract 14252: Redefining the Blanking Period After Cryoballoon Ablation for Atrial Fibrillation: From Korean Cryoballoon Ablation Registry

Background: Early recurrence (ER) of atrial arrhythmia in blanking period (<3 months) after radiofrequency ablation for atrial fibrillation (AF) has been considered as benign episode. Recently, there were controversies of long-term outcome of ER in radiofrequency ablation. the evidences of long-term impact of ER in cryoballoon ablation was still lacking. Hypothesis: There would be a significant impact of ER in patients with cryoballoon ablation on late recurrence of atrial tachyarrhythmia. Thus, this study sought to evaluate long-term outcome according to presence and timing (<1 month, 1-2 months, 2-3 months) of ER after cryoballoon ablation. Methods: Using the data from a multicenter registry of cryoballoon ablation for AF in Korea between May 01, 2018, and June 30, 2022, we identified 2,654 eligible patients. The primary outcome was late recurrence of atrial tachyarrhythmia including atrial fibrillation, atrial flutter, or atrial tachycardia longer than 30 seconds, excluding a blanking period of 3 months. A multivariable Cox proportional hazard model was performed to evaluate the impact of ER for late recurrence of AF. Results: Among 2,654 patients, 763 (28.7%) patients experienced ER of atrial arrhythmia after cryoballoon ablation. During mean follow-up periods (21.2 ± 10.3 months) after 3-month blanking period, 874 (32.9%) patients developed late recurrence of atrial arrhythmia. The 1-year freedom from late recurrence were 85.5% in patients without ER, 44.1% in those with ER <1 month, 32.4% in those with ER of 2-3 month, and 39.0% in those of ER with 2-3 month, respectively ( p = 0.0001). In multivariable Cox proportional hazard model, ER was significantly associated with late recurrence (hazard ratio: 3.98; 95% confidence intervals: 3.47-4.57) ( p = 0.001). Conclusion: Anytime ER after cryoballoon ablation is a significant predictor of late recurrence of atrial arrhythmia.

Surgical strategies and outcomes for myocardial bridges coexisting with other cardiac conditions

BackgroundMyocardial bridges are congenital coronary artery anomalies. There are still many controversies surrounding surgical treatment strategies for myocardial bridges combined with other heart disorders. The purpose of this study was to evaluate the surgical treatment strategies and outcomes in patients with these conditions.MethodsBetween March 2004 and October 2021, our institution witnessed 77 patients diagnosed with myocardial bridging who underwent surgical intervention. According to the myocardial bridge and combined heart disorder, four groups were identified: 1. isolated LAD supra-arterial myotomy group, 2. LAD CABG and(or not) myotomy group, 3. LAD supra-arterial myotomy and grafting of other branches group, and 4. LAD supra-arterial myotomy and other cardiac surgery group. The perioperative outcomes, symptoms, life quality, mortality, and major adverse cardiac events (MACEs) were analyzed.ResultsThere were no deaths during hospitalization and no rethoractomy for postoperative bleeding or major adverse cardiac events (MACEs). The follow-up period ranged from 2 months to 199.2 months (55.61 ± 10.21) months, the 10-year cumulative survival rates for the four groups of patients were 95.0%, 100%, 100% and 74.1%, and the 10-year freedom rates from the MACEs were 83.9%, 92.0%, 87.5% and 76.2%, respectively.ConclusionsSupra-arterial myotomy is preferred in patients with isolated myocardial bridge, and acceptable results can be achieved by choosing supra-arterial myotomy in combination with CABG or other cardiac surgery simultaneously for patients with myocardial bridges and other heart disorders.

Ultrasound Surveillance is Feasible After Endovascular Aneurysm Repair

IntroductionSurveillance after endovascular aneurysm repair (EVAR) is traditionally done with computed tomography angiography (CTA) scans that exposes patient to radiation, nephrotoxic contrast media, and potentially increased risk for cancer. Ultrasound (US) is less labor intensive and expensive and might thus provide a good alternative for CTA surveillance. The aim of this study was to evaluate in real-life patient cohorts whether US is able to detect post-EVAR aneurysm-related complications similarly to CTA. MethodsThis retrospective study compared the outcome of consecutive patients who underwent EVAR for intact abdominal aortic aneurysm (AAA) and were surveilled solely by CTA (CTA-only cohort, n= 168) in 2000-2010 or by combined CTA and US (CTA/US cohort, n= 300) in 2011-2016, as a standard surveillance protocol in department of vascular surgery, Helsinki University Hospital. The CTA-only patients were imaged at 1, 3, and 12 months and annually thereafter. The CTA/US patients were imaged with CTA at 3 and 12 months, US at 6 months and annually thereafter. If there were suspicion of >5 mm aneurysm growth, CTA scan was performed. The patients were reviewed for imaging data, reinterventions, aneurysm ruptures, and death until December 2018. The two groups were compared for secondary rupture, aneurysm- and cancer-related death, reintervention related to AAA, and maximum aneurysm diameter increase >5 mm. The mean follow-up in the CTA-only cohort was 67 months and in CTA/US cohort 43 months. ResultsThe two cohorts were alike for basic characteristics and for the mean aneurysm diameter. The total number of CT scans for detecting aneurysm was 84.1/100 patient years in the CTA-only cohort compared to 74.5/100 patient years for US/CTA-cohort. 40 % of patients under combined CTA/US surveillance received one or more additional CTA scans. The two cohorts did not differ for 1-, 5- and 8-year freedom from aneurysm related death, secondary sac rupture, nor the incidence of rupture preventing interventions. ConclusionBased on the follow up data of this real-life cohort of 468 patients, combined surveillance with US and additional CTA either per protocol or due to suspicion of aneurysm-related complications had comparable outcome with sole CTA-surveillance. Thus, US can be considered a reasonable alternative for the CTA. However, our study showed also that the need of additional CTAs due to suspicion of endoleak or aneurysm non-related reasons is substantial.

Pencil Beam Scanning Proton Therapy for Adolescents and Young Adults with Head and Neck Sarcomas

PurposeTo assess clinical outcomes of adolescents and young adults (AYAs) with head and neck sarcomas (HNSs) treated with pencil beam scanning proton therapy (PBSPT) and to report quality of life (QoL). Materials and MethodsTwenty-eight AYAs (aged 15 to 39 years) with HNS treated between January 2001 and July 2022 at our institution were included. The median age was 21.6 years. Rhabdomyosarcoma (39.3%), Ewing sarcoma (17.9%), chondrosarcoma (14.3%), and osteosarcoma (14.3%) were the most frequent diagnoses. Three (10.7%) patients were metastatic before PBSPT and 13 (46.4%) patients had a tumor with intracranial extension. The median total radiation dose was 63 GyRBE (range, 45 to 74 GyRBE). Thirteen (46.4%) patients received concomitant chemotherapy. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (US National Institutes of Health, Bethesda, Maryland). Survival was estimated using the Kaplan-Meier method. QoL was assessed using a PEDQOL (Pediatric Quality of Life Questionnaire) questionnaire. Self-reported outcomes were assessed using institutional questionnaires. ResultsWith a median follow-up of 57 months (range, 3.7 to 243 months), 5 patients (17.8%) had local failure (LF) only, 2 (7.1%) experienced distant failure (DF) only, and 2 (7.1%) had LF and DF. The estimated 5-year local control (LC) and distant control (DC) rates were 71.8% and 80.5%, respectively. The median times to LF and DF were 13.4 and 22.2 months, respectively. Four (14.3%) patients died, all but one from their HNS. Estimated 5-year overall survival was 90.7%. Six (21.4%) patients developed nonocular grade ≥3 toxicity, which consisted of otitis media (n = 2), hearing impairment (n = 2), osteoradionecrosis (n = 1), and sinusitis (n = 1). Four (14.3%) patients developed cataracts that required surgery. The 5-year freedom from nonocular grade 3 toxicity was 91.1%. No grade 4 or higher toxicity was observed. Adolescents rated their quality of life before treatment worse than their parents did. ConclusionExcellent outcomes with acceptable late-toxicity rates were observed for AYAs with HNS after PBSPT.

Minimally Invasive Mitral Valve Surgery With Concomitant Cox Maze Procedure Is as Effective as a Median Sternotomy With Decreased Morbidity.

A right minithoracotomy (RMT) is a minimally invasive surgical approach that has been increasingly performed for the concomitant Cox maze IV procedure (CMP) and mitral valve surgery (MVS). Little is known regarding whether long-term rhythm and survival outcomes are affected by the RMT as compared with the traditional median sternotomy (MS) approach. Between April 2004 and April 2021, 377 patients underwent the concomitant CMP and MVS, of whom 38% had RMT. Propensity score matching yielded 116 pairs. Freedom from atrial tachyarrhythmias (ATA) was assessed with prolonged monitoring annually for 8 years. Survival, rhythm, and perioperative outcomes were compared. The unmatched RMT cohort had a greater freedom from ATA recurrence at 1 year (99% vs 90%, P = 0.001) and 3 years (94% vs 86%, P = 0.045). The matched RMT cohort had longer cardiopulmonary bypass (median: 215 [199 to 253] vs 170 [136 to 198] min, P < 0.001) and aortic cross-clamp (110 [98 to 124] vs 86 [71 to 102] min, P < 0.001) times but shorter intensive care time (48 [24 to 95] vs 71 [26 to 144] h, P = 0.001) and length of stay (8 [6 to 11] vs 10 [7 to 14] h, P < 0.001). More pacemakers (18% vs 4%, P < 0.001) and postoperative transfusions (57% vs 41%, P = 0.014) occurred in the MS cohort. The 30-day mortality (P = 0.651) and 8-year survival (P = 0.072) was not significantly different between the cohorts. Early 1-year and 3-year freedom from ATA recurrence was better in the RMT cohort compared with the MS cohort. Despite longer operative times, the RMT cohort had shorter lengths of stay, fewer postoperative transfusions, and fewer pacemakers placed.

Cardiac risk after elective endovascular repair for infrarenal abdominal aortic aneurysm: Results from the Italian Collaborators for EVAR multicenter registry

ObjectiveMajor adverse cardiac events (MACEs) were common complications after endovascular aortic repair (EVAR) causing significant postoperative morbidity and mortality. The aim of the study was to evaluate the cardiac risk after elective EVAR for uncomplicated noninfected infrarenal abdominal aortic aneurysm in a large multicenter cohort. MethodsThis is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study conducted by four academic tertiary referral hospitals from January 2018 to March 2021. Baseline, perioperative, and postoperative information of elective EVARs was evaluated. The primary outcome was the incidence of MACEs after EVAR, which was defined as acute coronary syndrome, non-ST-elevation myocardial infarction, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, and revascularization as well as cardiovascular death. Secondary outcomes were 1-year overall survival (all-cause mortality) and freedom from aorta-related mortality. Comparative analysis was conducted between MACE and overall population, and univariate and multivariate logistic regression analyses were used to analyze factors associated with the risk of the MACE occurrence and early 1-year mortality. ResultsThe study has enrolled 497 patients (35 females, 7%) with a mean age of 75.3 ± 7.8 years. The MACE rate was 6.4% (32/497, events/patients), and the majority of the events were recorded in the postoperative period (24/32, 75%; overall 24/497, 4.8%). One-year survival from all-cause mortality was 94% (95% confidence interval [CI]: 91-96), and the MACE population showed a significantly lower survival estimation rate (Overall - MACEs, 95.8% [95% CI: 93-97] - 67.9% [95% CI: 47-82], log-rank 41.950, P = .0001). Freedom from aorta-related mortality was 99.3% (95% CI: 98-100). The perioperative need for red blood cell transfusions was strongly related to the MACE occurrence (odds ratio: 2.67, 95% CI: 1.52-4.68, P = .001) and 1-year mortality (hazard ratio: 2.14, 95% CI: 1.48-3.09, P = .0001). ConclusionsMACEs represent a common complication in the postoperative and early period after elective EVAR. Blood loss requiring red blood cell transfusions is associated with increased postoperative MACEs and early mortality, suggesting that all the efforts should be carried out to reduce the bleeding during and after elective interventions.

Outcome of dose-escalated intensity-modulated radiotherapy for limited disease small cell lung cancer.

An optimal once-daily radiotherapy (RT) regimen is under investigation for definitive concurrent chemoradiotherapy (CCRT) in limited disease small cell lung cancer (LD-SCLC). We compared the efficacy and safety of dose escalation with intensity-modulated radiotherapy (IMRT). Between January 2016 and March 2021, patients treated with definitive CCRT for LD-SCLC with IMRT were retrospectively reviewed. Patients who received a total dose <50 Gy or those with a history of thoracic RT or surgery were excluded. The patients were divided into two groups (standard and dose-escalated) based on the total biologically effective dose (BED, α/β = 10) of 70 Gy. The chemotherapeutic regimen comprised four cycles of etoposide and cisplatin. One hundred and twenty-two patients were analyzed and the median follow-up was 27.8 months (range, 4.4 to 76.9 months). The median age of the patients was 63 years (range, 35 to 78 years) and the majority had a history of smoking (86.0%). The 1- and 3-year overall survival rates of the escalated dose group were significantly higher than those of the standard group (93.5% and 50.5% vs. 76.7% and 33.3%, respectively; p = 0.008), as were the 1- and 3-year freedom from in-field failure rates (91.4% and 66.5% vs. 73.8% and 46.9%, respectively; p = 0.018). The incidence of grade 2 or higher acute and late pneumonitis was not significantly different between the two groups (p = 0.062, 0.185). Dose-escalated once-daily CCRT with IMRT led to improved locoregional control and survival, with no increase in toxicity.

A Multi-Institutional Analysis of MRI-Based Brachytherapy for Medically Inoperable Endometrial Cancer

Patients with medically inoperable endometrial cancer (MIEC) are curable with brachytherapy (BT)-based treatment yet have competing comorbidities making definitive treatment challenging. MRI demonstrates superior soft tissue anatomy and target volume delineation but with limited data in MIEC patients. We aim to report disease and toxicity outcomes with MRI-based BT and identify dose-volume relationships for toxicities in the treatment of MIEC patients treated with MRI-based BT. We conducted a retrospective multi-institutional analysis of MIEC patients undergoing definitive MRI-based BT (+/- EBRT). MRI-based BT was delivered with the applicator in situ or coregistered to a planning CT. We identified patient, tumor, and dosimetric factors associated with disease and toxicity outcomes. Kaplan-Meier method was used for survival estimates. Log rank test and Cox proportional hazards were used for univariate and multivariate analyses, respectively. T-test was used for dose-volume toxicity analysis. A total of 120 patients were included with a median follow up of 28.0 months. Median age was 68.5 years. ECOG PS was 0-1 in 70%. Clinical stage I was 83.3% and II-IV, 16.7%. Most patients (91.7%) were node negative. Endometrioid and high risk histologies comprised 83.3%, and 16.7%, respectively. EBRT + BT was delivered in 97 patients (80.8%) and BT alone in 23 patients (19.2%). Chemotherapy or hormonal therapy was delivered during treatment in 10 (8.3%) and 11 (9.2%) patients, respectively. Estimated 3-year freedom from local, nodal, and distant recurrence were 88.0%, 96.0%, and 89.1% respectively. Estimated 3-year PFS and OS were 60.9% and 62.9%, respectively. On UVA, older age, PS ≥2, high risk histology, higher grade, and larger GTV at BT were significant (p<0.1). On MVA, older age, higher grade, and larger GTV at BT (p<0.05) predicted for inferior PFS. Fifteen late grade ≥3 toxicities were experienced in 14 (11.6%) patients, 13 of whom received EBRT and BT and 1 who received BT alone. Grade ≥3 toxicities were rectal (2, 1.7%), sigmoid (8, 6.7%), bowel (1, 0.8%), bladder (3, 2.5%), and osseous (1, 0.8%). EBRT was delivered in 7 of 8 sigmoid toxicities. Median sigmoid doses (EQD2a/b = 3Gy) for patients with and without late grade ≥3 sigmoid toxicity were 69.6 Gy and 64.3 Gy, respectively (p = 0.009). MRI-based BT for MIEC patients results in high rates of local control and favorable rates of late grade ≥3 morbidity. Older age, higher grade, and larger GTV at BT predicted for poorer PFS. Sigmoid colon was the predominant organ at risk for grade ≥3 toxicity with a dose -volume relationship observed. Attention to the location of the sigmoid throughout the treatment course may add insight into its predilection for risk. Future work will include additional institutions and dose-volume relationships of target volumes and normal tissues for further disease control and toxicity analysis.

Safety and efficacy of delaying lung transplant surgery to a morning start

ObjectiveWe aimed to evaluate the safety and efficacy of delaying lung transplantation until morning for donors with cross-clamp times occurring after 1:30 am. MethodsAll consented adult lung transplant recipients between March 2018 and May 2022 with donor cross-clamp times between 1:30 am and 5 am were enrolled prospectively in this study. Skin incision for enrolled recipients was delayed until 6:30 am (Night group). The control group was identified using a 1:2 logistic propensity score method and included recipients of donors with cross-clamp times occurring at any other time of day (Day group). Short- and medium-term outcomes were examined between groups. The primary endpoint was early mortality (30-day and in-hospital). ResultsThirty-four patients were enrolled in the Night group, along with 68 well-matched patients in the Day group. As expected, donors in the Night group had longer cold ischemia times compared to the Day group (344 minutes vs 285 minutes; P < .01). Thirty-day mortality (3% vs 3%; P = .99), grade 3 primary graft dysfunction at 72 hours (8% vs 4%; P = .40), postoperative complications (26% vs 38%; P = .28), and hospital length of stay (15 days vs 14 days; P = .91) were similar in the 2 groups. No significant differences were noted between groups in 3-year survival (70% vs 77%; P = .30) or freedom from chronic lung allograft dysfunction (91% vs 95%; P = .75) at 3 years post-transplantation. The median follow-up was 752.5 days (interquartile range, 487-1048 days). ConclusionsLung transplant recipients with donor cross-clamp times scheduled after 1:30 am may safely have their operations delayed until 6:30 am with acceptable outcomes. Adoption of such a policy in clinically appropriate settings may lead to an alternative workflow and improved team well-being.

Superior mesenteric artery-related outcomes in fenestrated/branched endografting for complex aortic aneurysms.

Early/follow-up durability of superior mesenteric artery (SMA) stent-grafts is crucial after fenestrated/branched endografting (FB-EVAR) in complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). The study aimed to report early/midterm outcomes of SMA incorporated during FB-EVAR procedures. FB-EVAR procedures performed between 2016 and 2021 in a single institution were reviewed. Anatomical SMA characteristics were analyzed. The SMA configuration was classified into three types according to the angle between the SMA main trunk and the aorta: (A) perpendicular, (B) downward, and (C) upward. SMA-related technical success (SMA-TS: cannulation and stenting, patency at completion angiography without endoleak, stenosis/kinking, dissection, bleeding, and 24-h mortality) and SMA-adverse events (SMA-AEs: one among bowel ischemia, stenosis, occlusion, endoleak, reinterventions, or SMA-related mortality) were assessed. Two hundred FB-EVAR procedures with SMA as the target artery were performed. The indication for FB-EVAR was CAAAs and TAAAs in 99 (49%) and 101 (51%) cases, respectively. The SMA configuration was A, B, and C in 132 (66%), 63 (31%), and 5 (3%) cases, respectively. SMA was incorporated with fenestrations and branches in 131 (66%) and 69 (34%) cases, respectively. Directional branch (P < .001), aortic diameter ≥35 mm at the SMA level (P < .001), and ≥2 SMA bridging stent-grafts (P = .001) were more frequent in TAAAs. Relining of the SMA stent-graft with a bare metal stent was necessary in 41 (21%) cases to correct an acute angle between the stent-graft and native artery (39), stent-graft stenosis (1), or SMA dissection (1). Relining was associated with type A or C SMA configuration (OR: 17; 95% CI: 1.8-157.3; P = .01). SMA-TS was achieved in all cases. Overall, 15 (7.5%) patients had SMA-AEs [early: 9 (60%), follow-up: 6 (40%)] due to stenosis (2), endoleak (8), and bowel ischemia (5). Aortic diameter ≥35 mm at the SMA level was an independent risk factor for SMA-AEs (OR: 4; 95% CI: 1.4-13.8; P = .01). Fourteen (7%) patients died during hospitalization with 10 (5%) events within the 30-postoperative day. Emergency cases (OR: 33; 95% CI: 5.7-191.3; P = .001), peripheral arterial occlusive disease (OR: 14; 95% CI: 2.3-88.8; P = .004), and bowel ischemia (OR: 41; 95% CI: 1.9-87.9; P = .01) were risk factors for 30-day/in-hospital mortality. The mean follow-up was 32 ± 24 months; estimated 3-year survival was 81%, with no case of late SMA-related mortality or occlusion. The estimated 3-year freedom from overall and SMA-related reinterventions was 74% and 95%, respectively. SMA orientation determines the necessity of stent-graft relining. Aortic diameter ≥35 mm at the SMA level is a predictor of SMA-AEs. Nevertheless, SMA-related outcomes of FB-EVAR are satisfactory, with excellent technical success and promising clinical outcomes during the follow-up.

Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis

ObjectiveAs bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. MethodsThis was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. ResultsBetween January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm2 (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed. ConclusionsWe report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses.

Right ventricular papillary muscle approximation to the septum as an adjunct technique during tricuspid valve repair in congenital heart surgery

ObjectiveTricuspid regurgitation is often caused by leaflet splaying from displaced papillary muscles or ventricular dilatation. Traditional annuloplasty may not address this mechanism. The present study describes a single institution's experience using right ventricular papillary muscle approximation for tricuspid valve repair. MethodsRight ventricular papillary muscle approximation consists of suturing the anterior papillary muscle to a point of the septum (septum or septal papillary muscle) that optimizes leaflet coaptation. We describe our technique and analyze clinical data of patients undergoing tricuspid valve repair with right ventricular papillary muscle approximation during congenital heart surgery between 2012 and 2021. ResultsRight ventricular papillary muscle approximation was performed as an adjunct procedure in 207 of 825 tricuspid valve repairs (25.1%). Discharge tricuspid regurgitation grade was mild tricuspid regurgitation or less in 153 patients (73.9%), and 140 patients (67.6%) had mild tricuspid regurgitation or less at a median latest follow-up of 3.2 years (interquartile range, 0.7-6.8). Thirty patients (14.5%) underwent 11 early tricuspid valve reinterventions (3 due to right ventricular papillary muscle approximation dehiscence) and 21 late tricuspid valve reinterventions. Estimated 5-year freedom from tricuspid valve reintervention was 84% (95% CI, 77.0-89.2). Systemic right ventricle physiology (odds ratio, 2.88, P = .048) and multiple mechanisms of tricuspid regurgitation (odds ratio, 7.35, P = .038) were significant predictors of tricuspid valve reintervention on multivariable analysis. ConclusionsTricuspid valve repair with right ventricular papillary muscle approximation demonstrates acceptable short-term durability, but similar to other tricuspid valve repair strategies is less durable in patients with systemic right ventricle pressure and multiple mechanisms of tricuspid regurgitation. Right ventricular papillary muscle approximation is a safe and effective adjunct technique that should be considered in patients with tricuspid regurgitation caused by leaflet splaying from displaced papillary muscles or right ventricle dilatation.