MAE Rate Research Articles

Free-Cell Area Impact on Stroke Prevention in Asymptomatic Patients Undergoing Carotid Artery Stenting: The "Carotid Artery sTenting And CeLl-area Impact on Stroke and Major Adverse events" (CATACLISMA) Multicenter Registry.

The study investigated the association between cell-stent area and cerebrovascular events incidence in asymptomatic patients undergoing carotid artery stenting (CAS). This is an observational, retrospective, multicenter, cohort study. Between 2012 and 2022, all patients undergoing primary CAS for severe asymptomatic carotid artery stenosis were evaluated. Three groups were defined on the basis of the cell area (open cell, OC; closed cell, CC; double layer, DL). Periprocedural primary outcomes were 30-day stroke, mortality, myocardial infarction (MI), and major adverse event (MAE, stroke/mortality composite outcome) rates. Follow-up primary outcomes included overall survival, stroke-free survival (SFS), freedom from ipsilateral stroke (FFiS), and freedom from stroke-related mortality (FF-SRM). Data were analyzed at short-term (1 year) and mid-term (2.5 years) period. A total of 1096 CAS were considered (787 men, 71.8%, median age = 74 years). Technical success was achieved in 99.5% procedures. Periprocedural 30-day stroke rate was 1.5% (OC: 1.1%, CC: 2.3%, DL: 1%, p=0.27), mortality was 0.7% (OC: 1.1%, CC: 0.3%, DL: 0.5%, p=0.35), and no MI was recorded. The MAE rate was 2.1% (OC: 2%, CC: 2.6%, DL: 1.5%, p=0.66). Median follow-up was 46 months. At 1 and 2.5 years, estimated overall survival was 96.1% and 91% (p=0.41), SFS was 99.1% and 98.2% (p=0.007, CC stroke rates 2.9% and 4.2% at timepoints), FFiS was 99.4% and 99% (p=0.014, CC FFiS rates 1.7% and 2.6% at timepoints) and FF-SRM was 99.5% and 99% (p=0.28). During follow-up, no stroke events occurred in DL group. CC design showed higher rates of any (4.2%) and ipsilateral stroke (2.6%) within 2.5 years. In asymptomatic patients undergoing CAS, the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. The DL stents may offer the best available performances in terms of mid-term stroke prevention. The study analyzed the contemporary results of carotid artery stenting (CAS) focusing on the impact of cell-stent area on peri- and post-operative cerebrovascular events in a multicenter real-world experience. In asymptomatic patients undergoing CAS the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. DL stents may offer the best available performances in terms of mid-term stroke prevention.

Enterprise supply chain network optimization algorithm based on blockchain-distributed technology under the background of digital economy

Demand forecasting is essential for streamlining supply chain operations in the digital economy and exceeding customer expectations. On the other hand, traditional forecasting techniques cannot frequently present real-time data and respond to dynamic changes in the supply chain network, leading to less-than-ideal decision-making and higher costs. This research aims to create a technique for optimizing the supply chain network based on blockchain-distributed technology (SCN-BT) to overcome these drawbacks and fully utilize the potential of the digital economy. The suggested framework uses the hybridized LSTM network and Grey Wolf Optimization (GWO) algorithm to examine demand forecasting in the supply chain network for inventory planning. The SCN-BT framework develops a safe and productive, enabling precise and flexible demand by combining blockchain with optimization techniques. A thorough case study utilized information collected from an enterprise supply chain that operates in the digital economy to show the efficiency of the suggested framework. Compared to conventional approaches, the results show considerable gains in demand forecasting precision, responsiveness of the supply chain, and cost-effectiveness. In the context of the digital economy, demand sensing and prediction enable firms to react to changes swiftly, shorten turnaround times, optimize inventory levels, and improve overall supply chain performance. The results highlight how blockchain technology has the potential to enhance collaboration, trust, and transparency inside intricate supply chain networks working in the digital economy. The experimental results show the proposed to achieve prediction rate of demand prediction rate of 128.93, demand forecasting accuracy ratio of 92.18%, optimum efficiency of 94.25%, RMSE rate of 1841.25, MAE rate of 260.74, and sMAPE rate of 0.1002 compared to other methods.

Viabahn endoprosthesis for femoropopliteal aneurysm repair: safety, success rates, and long-term patency

BackgroundThe Viabahn endoprosthesis has become a vital option for endovascular therapy, yet there is limited long-term data on its effectiveness for peripheral aneurysm repair. This study aimed to evaluate the safety, technical and clinical success, and long-term patency of the Viabahn endoprosthesis for treating femoropopliteal aneurysms.MethodsThis retrospective tertiary single-center study analyzed patients who underwent a Viabahn endoprosthesis procedure for femoropopliteal aneurysm repair from 2010 to 2020. Intraoperative complications, technical and clinical success rates, and major adverse events (MAE, including acute thrombotic occlusion, major amputation, myocardial infarction, and device- or procedure-related death) at 30 days were assessed. Incidence of clinically-driven target lesion revascularisation (cdTLR) was noted. Patency rates were evaluated by Kaplan–Meier analysis.ResultsAmong 19 patients (mean age, 72 ± 12 years; 18 male, 1 female) who underwent aneurysm repair using the Viabahn endoprosthesis, there were no intraoperative adverse events, with 100% technical and clinical success rates. At the 30-day mark, all patients (19/19, 100%) were free of MAE. The median follow-up duration was 1,009 days [IQR, 462–1,466]. Popliteal stent graft occlusion occurred in 2/19 patients (10.5%) after 27 and 45 months, respectively. Consequently, the primary patency rates were 100%, 90%, 74% at 12, 24, and 36–72 months, respectively. Endovascular cdTLR was successful in both cases, resulting in sustained secondary patency at 100%.ConclusionThe use of Viabahn endoprostheses for femoropopliteal aneurysm repair demonstrated technical and clinical success rates of 100%, a 0% 30-day MAE rate, and excellent long-term patency.

DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease

ObjectivePercutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. MethodsThe DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. ResultsWe enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. ConclusionsThe DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

Transradial carotid artery stenting using double layer micromesh stent and novel post-dilation balloon with integrated embolic protection

ObjectivesThe highest rate of embolization during carotid artery stenting occurs during post-dilation. We evaluated the ability of the Paladin system (Contego Medical, Raleigh, NC), a novel PTA balloon with an integrated 40-ɥm pore filter, to collect microemboli that may pass into the cerebral circulation when used during post-dilation. Methods25 symptomatic patients underwent transradial CAS using the Paladin system in conjunction with the Roadsaver (Terumo Corporation, Tokyo, Japan) micromesh stent. No additional embolic protection was used. The Paladin filters were collected following the procedure and preserved in formalin for histological analysis. The contents were evaluated for particle count and size. Subjects were followed for 30 days and evaluated for major cardiac adverse events (death, stroke and MI). Secondary endpoints included procedure success, device success, access site complications according to EASY score classification, major vascular or ischemic complications at follow up and in-stent restenosis rate evaluated with duplex ultrasound. ResultsMean age of patients was 68,5 years. Type 2 aortic arch was present in 77 % of patients and type 1 and type 3 in 12 % and 11 % of patients respectively. Procedural and device success was obtained in all cases without complications. The 30-day MAE rate was 0 %. Twenty-three filters underwent histological analysis. Microscopic debris was present in 100 % of filters, and 75 % of particles were less than 100ɥm in size. The mean number of particles per filter was 3352 ± 1567 (IQR 4300–2343), and the mean number of particles between 40-100ɥm per filter was 2499 ± 1240 (IQR 3227–1575). ConclusionCAS through radial approach can be safely and effectively performed using the IEP technology Paladin device and double-layer micromesh Roadsaver stent. This strategy can simplify the procedure and decrease peri-procedural complications and procedural time.

Stock market prediction-COVID-19 scenario with lexicon-based approach

Stock market forecasting remains a difficult problem in the economics industry due to its incredible stochastic nature. The creation of such an expert system aids investors in making investment decisions about a certain company. Due to the complexity of the stock market, using a single data source is insufficient to accurately reflect all of the variables that influence stock fluctuations. However, predicting stock market movement is a challenging undertaking that requires extensive data analysis, particularly from a big data perspective. In order to address these problems and produce a feasible solution, appropriate statistical models and artificially intelligent algorithms are needed. This paper aims to propose a novel stock market prediction by the following four stages; they are, preprocessing, feature extraction, improved feature level fusion and prediction. The input data is first put through a preparation step in which stock, news, and Twitter data (related to the COVID-19 epidemic) are processed. Under the big data perspective, the input data is taken into account. These pre-processed data are then put through the feature extraction, The improved aspect-based lexicon generation, PMI, and n-gram-based features in this case are derived from the news and Twitter data, while technical indicator-based features are derived from the stock data. The improved feature-level fusion phase is then applied to the extracted features. The ensemble classifiers, which include DBN, CNN, and DRN, were proposed during the prediction phase. Additionally, a SI-MRFO model is suggested to enhance the efficiency of the prediction model by adjusting the best classifier weights. Finally, SI-MRFO model’s effectiveness compared to the existing models with regard to MAE, MAPE, MSE and MSLE. The SI-MRFO accomplished the minimal MAE rate for the 90th learning percentage is approximately 0.015 while other models acquire maximum ratings.

Totally percutaneous endovascular repair for ruptured abdominal aortic aneurysms.

The PEVAR Trial demonstrated that compared to open femoral exposure, elective percutaneous endovascular AAA repair (ePEVAR) is associated with decreased perioperative morbidity and access site complications. We hypothesized that PEVAR for ruptured AAA (rPEVAR) may also improve perioperative morbidity compared to open femoral exposure (rEVAR). There are currently no reports that evaluate the utility and outcomes of rPEVAR. From 2015 to 2021, all patients who underwent an endovascular repair of a ruptured AAA at a single institution were included in the study and grouped into rPEVAR and rEVAR. Demographics, procedural details (successful preclose technique, conversion to femoral cutdown), postoperative variables (blood transfusion, ICU and hospital length of stay) and short-term outcomes (30-day major adverse events (30-day MAE) and 30-day femoral access-site complications (30-day FAAC)) were collected and compared with 50 historical ePEVAR patients from the PEVAR Trial. Statistical significance was determined using χ 2 or Fisher's exact test for categorical variables, and Mann-Whitney U-test for continuous variables. 35 patients were identified (21 rPEVAR; 14 rEVAR), 86% were male with a mean age of 72 ± 9 years. All patients underwent emergent endovascular aortic repair with 100% technical success. Seventeen patients (49%) presented with evidence of hemorrhagic shock and 22 patients (63%) had blood transfusion. 30-day MAE occurred in 12 patients (34%) (7 rPEVAR; 5 rEVAR). There was no difference in demographic, perioperative outcomes and 30-day MAE rate between rPEVAR and rEVAR patients. Compared to ePEVAR patient (from PEVAR trial), rPEVAR patients had higher rate of 30-day MAE (34% vs. 6%; p < 0.006) but no difference in 30-day FAAC (19% vs. 12%; p = 0.54). The success rate of the preclose technique was higher in ePEVAR compared to rPEVAR (96% vs. 76%; p = 0.02), but the rate of conversion to femoral cutdown was similar between the two groups (10% vs. 4%; p = 0.57). Emergent rPEVAR appears to have similar outcomes when compared to rEVAR. Although patients undergoing rPEVAR have higher 30-day major adverse events rate compared to ePEVAR, the method of percutaneous femoral cannulation does not appear to increase the overall procedural or 30-day femoral artery access-site complications.

Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience

Background: Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. Patient Populations/Methods: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. Results: Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A–C lesions. Mean follow-up was 18.4 months (1–76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A–C vs 59% and 59% for D lesions, p=0.001). Conclusion: Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A–C lesions but inferior/unsatisfactory for TASC D lesions.

Submucosal tunneling endoscopic resection treatment of multiple gastrointestinal submucosal tumors.

Gastrointestinal submucosal tumors (SMTs) can be removed by submucosal tunneling endoscopic resection (STER). However, limited studies have evaluated STER for the removal of multiple upper gastrointestinal SMTs. The aim of this study was to evaluate the feasibility and outcomes of STER in the treatment of multiple upper gastrointestinal SMTs. From January 2011 to April 2020, the cases of patients with multiple upper gastrointestinal SMTs undergoing STER were retrospectively analyzed. Variables of clinicopathological characteristics, major adverse events (mAEs), and follow up were collected and analyzed. Submucosal tunneling endoscopic resection was performed in 54 patients (48 male and 6 female patients) with 120 SMTs. Forty-four patients had two tumors, eight patients had three tumors, and two patients had four tumors. The median size of each patient was 1.8cm (range 0.7 to 3.5cm). Forty-five patients had tumors removed by one tunnel, and nine patients by two tunnels. The median procedure time was 50min (range 14 to 120min), and the mAE rate was 16.7% (9/54). No significant differences were found between patients with two tumors and those with >2 tumors in terms of tunnel length, hospital stay, procedure time, and mAEs (all P>0.05). In addition, patients with two tunnels had procedure time, hospital stay, and mAE rates comparable with those with one tunnel (all P>0.05). No local recurrence or distant metastasis occurred during a median follow up of 64months. Submucosal tunneling endoscopic resection is a safe and effective technique for the resection of multiple upper gastrointestinal SMTs.

Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.

We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p=.054) and KCCQ (17 points; p < .001). Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation

BackgroundTricuspid regurgitation (TR) is a prevalent disease with limited treatment options. ObjectivesThis is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. MethodsPatients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. ResultsOf the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). ConclusionsIn this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313)

Six-month and one-year outcomes with the PASCAL transcatheter valve repair system for patients with mitral regurgitation from the multicentre, prospective CLASP study

Abstract Background Transcatheter mitral valve repair has emerged as a viable option for treating mitral regurgitation (MR). We report results from the multicentre, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system. Methods 109 patients with clinically significant MR deemed candidates for transcatheter repair by the local heart team were treated in the CLASP study. The study evaluated safety, performance, clinical and echocardiographic outcomes and included an independent clinical events committee and echocardiographic core lab. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications. Results Mean age was 76 years, 54% male, 57% NYHA Class III/IV, 100% MR grade ≥3+ with 62% functional, 31% degenerative, 7% mixed etiology. Successful implantation was achieved in 95% of patients. At 30 days, the MAE rate was 8.3% including one cardiovascular mortality due to cardiogenic shock as a result of severe bleeding at the contralateral arterial access site for hemodynamic monitoring further complicated by disseminated intravascular coagulation, one stroke, and one conversion to mitral valve replacement surgery. In paired analysis, 88% of patients were in NYHA Class I/II (p&amp;lt;0.001), MR grade was ≤1+ in 79% of patients and ≤2+ in 96% of patients. Significant improvements in 6MWD (+27 m, p&amp;lt;0.001) and KCCQ (+16 points, p&amp;lt;0.001) were observed. The six-month data will be available for presentation. In addition, we report one-year follow up of the first 62 patients (ITT): 93% one-year survival rate (Kaplan-Meier estimate), no stroke, no late reintervention, one late MI. In paired analysis, MR grade was ≤1+ in 82% of patients and ≤2+ in 100% of patients. 88% of patients were in NYHA Class I/II (p&amp;lt;0.001), 6MWD improved by 21 m (p=0.124) and KCCQ improved by 13 points (p&amp;lt;0.001). Conclusions This study demonstrates the PASCAL transcatheter valve repair system is safe and resulted in robust MR reduction with 100% of patients achieving MR ≤2+, and ∼ 80% MR ≤1+, sustained at one year. Results show high survival and low complication rates, and sustained improvements in functional status, exercise capacity, and quality of life at one year in patients with clinically significant, symptomatic MR. The CLASP IID/IIF pivotal trial is underway. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Edwards Lifesciences (Irvine, CA)

Six-month and One-year Outcomes for Repair in Patients with Functional Mitral Regurgitation from the CLASP Study

Background Transcatheter mitral valve repair has emerged as a viable option for treating functional mitral regurgitation (FMR). We report results for the FMR cohort from the multicenter, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA). Methods Eligible patients had clinically significant and symptomatic MR ≥3+ and were deemed candidates for transcatheter repair by the local heart team. The study outcomes were evaluated by an independent clinical events committee and echocardiographic core lab. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications. Results Of the 109 patients enrolled (intent to treat/ITT and roll-in), 73 (67%) had FMR as determined by the core lab. Mean age was 73 years, 55% male, 60% NYHA Class III/IV with 100% MR grade ≥3+. Successful implantation was achieved in 96% of patients. At 30 days, the MAE rate was 11.0% including one cardiovascular mortality, one stroke, and one conversion to mitral valve replacement surgery. At 30 days, 88% of patients were in NYHA Class I/II (p Conclusions This study demonstrates that the PASCAL repair system is safe and results in remarkable MR reduction in patients with FMR. 100% of patients achieved MR ≤2+, and ∼ 80% achieved MR ≤1+, sustained at one year. Results show a high survival rate, low complications, and sustained improvements in functional status, exercise capacity, and quality of life at one year.

Endovascular Repair of Ruptured Abdominal Aortic Aneurysm Is Superior to Open Repair: Propensity-Matched Analysis in the Vascular Quality Initiative

The three randomized trials comparing endovascular aneurysm repair (rEVAR) with open surgical repair (rOSR) of ruptured abdominal aortic aneurysm (rAAA) were poorly designed and heavily criticized. The short- and long-term survival advantages of rEVAR remain unclear. We sought to compare the two treatment modalities using a propensity-matched analysis in a real-world setting. All rOSR and rEVAR procedures in the Vascular Quality Initiative were analyzed (2003-2018). Raw and propensity-matched rEVAR and rOSR cohorts were compared. Primary outcomes included postoperative major adverse events (MAEs; cardiovascular, pulmonary, renal, bowel/limb ischemia, reoperation) and 30-day and 1-year mortality. Univariate, multivariate, and Kaplan-Meier analyses were performed. There were 4929 rAAA repairs performed, 2749 rEVAR and 2180 rOSR. Compared with rEVAR, rOSR had higher myocardial ischemia events (15% vs 10%; P < .001), MAEs (67% vs 37%; P < .001), and 30-day death (34% vs 21%; P < .001; Table I). On adjusted analysis, rOSR was predictive of 30-day mortality (odds ratio, 1.9; 95% confidence interval, 1.6-2.2). After 1:1 matching, the study cohort consisted of 724 pairs of rOSR and rEVAR patients. The rOSR patients had twice the length of stay (median, 10 days [interquartile range, 5-19 days] vs 5 days [interquartile range, 3-10 days]; P < .001). Univariate analysis demonstrated persistent increased 30-day mortality after rOSR (32% vs 18%; P < .001) and higher rates of myocardial infarction (rOSR 14% vs rEVAR 8%; P = .002), respiratory complications (38% vs 20%; P < .001), and acute kidney injury (42% vs 26%; P < .001). Overall MAE rate was higher after rOSR (68% vs 35%; P < .001). Multivariable regression analysis of the propensity-matched pairs demonstrated that rOSR was associated with double the 30-day mortality compared with rEVAR (odds ratio, 2.1; 95% confidence interval, 1.7-2.8; Table II). All-cause 1-year survival was 73% and 59% after rEVAR and rOSR in the propensity-matched cohort, respectively (P < .001). This is the largest study of rAAA demonstrating clear short- and long-term survival benefit of rEVAR over rOSR that persisted after matching on all major demographic, comorbid, and anatomic variables. Furthermore, patients undergoing rOSR had twice the length of stay with increased rates of complications compared with rEVAR. These data suggest a more aggressive endovascular approach for rAAA in patients with suitable anatomy.Table IDemographics of matched and nonmatched patients undergoing endovascular aneurysm repair (rEVAR) or open surgical repair (rOSR) of ruptured abdominal aortic aneurysm (rAAA)NonmatchedMatchedrEVAR (n = 2749)rOSR (n = 2180)P valuerEVARa (n = 724)rOSRa (n = 724)P valueDemographics Age, years73 (66-81)72 (66-79)<.00172 (66-80)72 (66-79).79 Sex, female586 (21)475 (22).68127 (19)162 (22).10 White race2392 (87)1984 (91)<.001653 (90)660 (91).53Comorbidities Smoking history2083 (77)1761 (84)<.001590 (82)579 (80).46 CHF337 (13)196 (9)<.00159 (8)67 (9).46 COPD780 (29)705 (33).002217 (30)224 (31).69 ESRD45 (2)16 (1).011 (0.1)1 (0.1)1Anatomic Prior AAA repair73 (3)217 (10)<.00117 (2)19 (3).74 Maximum AAA diameter, mm71 (60-85)77 (64-90)<.00175 (63-89)75 (63-89)1 Iliac aneurysmal disease615 (24)476 (23).23179 (26)159 (22).12AAA, Abdominal aortic aneurysm; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; ESRD, end-stage renal disease.Categorical variables are presented as number (%). Continuous variables are presented as median (interquartile range).aMatched on type of operative repair, age, race, smoking history, congestive heart failure, chronic obstructive pulmonary disease, end-stage renal disease, prior AAA repair, maximal aortic sac diameter, preoperative medications. Open table in a new tab Table IIPredictors of 30-day mortality after ruptured abdominal aortic aneurysm (rAAA) repair in both unmatched (model 1) and matched (model 2) cohortsOR (95% CI)P valueModel 1: Unmatched cohorta Open operative repair1.86 (1.56-2.23)<.001 Age ≥60 years2.06 (1.33-3.20).001 Female sex1.53 (1.24-1.90)<.001 Obese1.32 (1.09-1.58).004 Congestive heart failure1.38 (1.04-1.83).03 Maximal AAA diameter ≥71 mm1.38 (1.06-1.81).02Model 2: Propensity-matched cohortb Open operative repair2.14 (1.66-2.77)<.001 Age ≥60 years2.59 (1.34-5.00).01 Female sex1.46 (1.07-1.98).02 Obese1.48 (1.14-1.93).004 Hypertension0.55 (0.41-0.74)<.001AAA, Abdominal aortic aneurysm; CI, confidence interval; OR, odds ratio.aAdjusts for type of repair, age, sex, race, obesity, smoking history, coronary artery disease, congestive heart failure, maximal aortic diameter, iliac aneurysmal disease.bAdjusts for type of repair, age, sex, obesity, smoking history, hypertension, preoperative medications, congestive heart failure, maximal aortic diameter, iliac aneurysmal disease. Open table in a new tab

Monoallelic expression in melanoma

BackgroundMonoallelic expression (MAE) is a frequent genomic phenomenon in normal tissues, however its role in cancer is yet to be fully understood. MAE is defined as the expression of a gene that is restricted to one allele in the presence of a diploid heterozygous genome. Constitutive MAE occurs for imprinted genes, odorant receptors and random X inactivation. Several studies in normal tissues have showed MAE in approximately 5–20% of the cases. However, little information exists on the MAE rate in cancer. In this study we assessed the presence and rate of MAE in melanoma. The genetic basis of melanoma has been studied in depth over the past decades, leading to the identification of mutations/genetic alterations responsible for melanoma development.MethodsTo examine the role of MAE in melanoma we used 15 melanoma cell lines and compared their RNA-seq data with genotyping data obtained by the parental TIL (tumor infiltrating lymphocytes). Genotyping was performed using the Illumina HumanOmni1 beadchip. The RNA-seq library preparation and sequencing was performed using the Illumina TruSeq Stranded Total RNA Human Kit and subsequently sequenced using a HiSeq 2500 according to manufacturer’s guidelines. By comparing genotyping data with RNA-seq data, we identified SNPs in which DNA genotypes were heterozygous and corresponding RNA genotypes were homozygous. All homozygous DNA genotypes were removed prior to the analysis. To confirm the validity to detect MAE, we examined heterozygous DNA genotypes from X chromosome of female samples as well as for imprinted and olfactory receptor genes and confirmed MAE.ResultsMAE was detected in all 15 cell lines although to a different rate. When looking at the B-allele frequencies we found a preferential pattern of complete monoallelic expression rather then differential monoallelic expression across the 15 melanoma cell lines. As some samples showed high differences in the homozygous and heterozygous call rate, we looked at the single chromosomes and showed that MAE may be explained by underlying large copy number imbalances in some instances. Interestingly these regions included genes known to play a role in melanoma initiation and progression. Nevertheless, some chromosome regions showed MAE without CN imbalances suggesting that additional mechanisms (including epigenetic silencing) may explain MAE in melanoma.ConclusionThe biological implications of MAE are yet to be realized. Nevertheless, our findings suggest that MAE is a common phenomenon in melanoma cell lines. Further analyses are currently being undertaken to evaluate whether MAE is gene/pathway specific and to understand whether MAE can be employed by cancers to achieve a more aggressive phenotype.

Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study (ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

Improved outcomes and value in staged hybrid extent II thoracoabdominal aortic aneurysm repair

ObjectiveComplex Crawford extent II thoracoabdominal aortic aneurysms (TAAAs) can be treated in a hybrid manner with proximal thoracic endovascular aneurysm repair, followed by staged distal open thoracoabdominal repair. This study evaluated the outcomes and health care-associated value of this new method compared with traditional open repair over 10 years. MethodsA prospectively collected database was used to identify all patients with an extent II TAAA undergoing repair at a single institution between 2005 and 2015. Patient characteristics, postoperative outcomes, and incidence of major adverse events (MAEs; renal failure, spinal cord ischemia, death) were compared. After adjusting for time since surgery, value was analyzed looking at quality (1/MAE) divided by cost (total health system cost). This was multiplied by a constant to set the value of open TAAA repair to 100. ResultsA total of 113 consecutive patients underwent extent II TAAA repairs, of whom 25 (22.1%) had a staged hybrid approach with a median of 129 days between procedures. No baseline differences in demographic or comorbidity variables existed between groups (P > .05). The hybrid group had shorter operative time (255 vs 306 minutes; P = .01), shorter postoperative length of stay (10.1 vs 13.3 days; P = .02), and reduced blood loss (1300 vs 2600 mL; P = .01) at the time of open operation. Despite higher rates of acute kidney injury in the hybrid group (76.0% vs 51.1%; P = .03), there was no difference in renal failure (8.0% vs 4.5%; P = .84). The incidence of MAEs was lower in the staged hybrid group (20.0% vs 48.9%; P = .01), without a difference in hospital mortality (4.0% vs 3.4%; P = .89). Median total cost was higher in the hybrid group ($112,920 vs $72,037; P = .003). Value was improved in the hybrid group by 56% using mean cost and 178% by median cost. ConclusionsThe 20% MAE rate associated with staged hybrid repair of extent II TAAA was significantly decreased compared with open repair, with a relative reduction of >50%. Despite higher total hospital costs, staged hybrid repair had 56% to 178% higher health care-related value compared with standard open repair. In an era of increasing focus on costs and quality, staged hybrid repair of extensive TAAAs is associated with fewer complications than open TAAA repair, resulting in a good value investment from a resource utilization perspective.

Anatomical and technical predictors of perioperative clinical outcomes after carotid artery stenting

BackgroundA few other studies have reported the effects of anatomical and technical factors on clinical outcomes of carotid artery stenting (CAS). This study analyzed the effect of these factors on perioperative stroke/myocardial infarction/death after CAS. MethodsThis was a retrospective analysis of prospectively collected data of 409 of 456 patients who underwent CAS during the study period. A logistic regression analysis was used to determine the effects of anatomical and technical factors on perioperative stroke, death, and myocardial infarction (major adverse events [MAEs]). ResultsThe MAE rate for the entire series was 4.7% (19 of 409), and the stroke rate was 2.2% (9 of 409). The stroke rate for asymptomatic patients was 0.46% (1 of 218; P = .01). The MAE rates for patients with transient ischemic attack (TIA) were 7% (11 of 158) vs 3.2% (8 of 251) for other indications (P = .077). The stroke rates for heavily calcified lesions were 6.3% (3 of 48) vs 1.2% (4 of 332) for mildly calcified/noncalcified lesions (P = .046). Differences in stroke and MAE rates regarding other anatomical features were not significant. The stroke rate for patients with percutaneous transluminal angioplasty (PTA) before embolic protection device (EPD) insertion was 9.1% (2 of 22) vs 1.8% (7 of 387) for patients without (P = .07) and 2.6% (9 of 341) for patients with poststenting PTA vs 0% (0 of 68) for patients without. The MAE rate for patients with poststenting PTA was 5.6% (19 of 341) vs 0% (0 of 68) for patients without (P = .0536). The MAE rate for patients with the ACCUNET (Abbott, Abbott Park, Ill) EPD was 1.9% (3 of 158) vs 6.7% (16 of 240) for others (P = .029). The differences between stroke and MAE rates for other technical features were not significant. A regression analysis showed that the odds ratio for stroke was 0.1 (P = .031) for asymptomatic indications, 13.7 (P = .014) for TIA indications, 6.1 (P = .0303) for PTA performed before EPD insertion, 1.7 for PTA performed before stenting, and 5.4 (P = .0315) for heavily calcified lesions. The MAE odds ratio was 0.46 (P = .0858) for asymptomatic indications, 2.1 for PTAs performed before EPD insertion, 2.2 for poststent PTAs, and 2.2 (P = .1888) for heavily calcified lesions. A multivariate analysis showed that patients with TIA had an odds ratio of stroke of 11.05 (P = .029). Patients with PTAs performed before EPD insertion had an OR of 6.15 (P = .062). Patients with heavily calcified lesions had an odds ratio of stroke of 4.25 (P = .0871). The MAE odds ratio for ACCUNET vs others was 0.27 (P = .0389). ConclusionsCalcific lesions and PTA before EPD insertion or after stenting were associated with higher stroke or MAE rates, or both. The ACCUNET EPD was associated with lower MAE rates. There was no correlation between other anatomical/technical variables and CAS outcome.

Major perioperative adverse events of peroral endoscopic myotomy: a systematic 5-year analysis.

Background and study aims: Peroral endoscopic myotomy (POEM) is now a widely used treatment for esophageal achalasia, supported by several large cohort studies. Although major perioperative adverse events (mAE) are rare, in-depth investigations of related risks and preventive measures are lacking. The aim of this study was to systematically assess mAEs during POEM by analyzing their incidence, risks, prevention, and management. Patients and methods: This retrospective single-center analysis included all patients (n = 1680) undergoing POEM between August 2010 and July 2015 at Zhongshan Hospital. Major adverse events were defined as: vital-sign instability, intensive care unit (ICU) stay, hospital readmission, conversion to open surgery, invasive postoperative procedure, blood transfusion, or prolonged (> 5 days) hospitalization for functional impairment. Results: A total of 55 patients (3.3 %, 95 % confidence interval [CI] 2.5 % - 4.2 %) experienced mAEs: delayed mucosal barrier failure (n = 13, 0.8 %; 95 %CI 0.4 % - 1.3 %), delayed bleeding (n = 3, 0.2 %; 95 %CI 0.04 % - 0.5 %), hydrothorax (n = 8, 0.5 %; 95 %CI 0.2 % - 0.9 %), pneumothorax (n = 25, 1.5 %; 95 %CI 1.0 % - 2.2 %), and miscellaneous (n = 6, 0.4 %; 95 %CI 0.1 % - 0.8 %). Four patients (0.2 %) required ICU admission. No surgical conversion occurred, and 30-day mortality was zero. In stepwise multivariate regression, institution experience of < 1 year (odds ratio [OR] 3.85, 95 %CI 1.49 - 9.95), air insufflation (OR 3.41, 95 %CI 1.37 - 8.50), and mucosal edema (OR 2.01, 95 %CI 1.14 - 3.53) were identified as related risk factors. After introducing CO2 insufflation, the mAE rate declined to 1.9 % (95 %CI 1.2 % - 2.7 %) and seemed to plateau after 3.5 years at ~ 1 %. Conclusion: In general, POEM appears to be a safe procedure. Major adverse events were rare and could usually be prevented or anticipated, and were all managed effectively.

Carotid artery stenting and patient outcomes: the CABANA surveillance study.

ObjectivesThe purpose of the prospective, multicenter, nonrandomized CABANA study was to evaluate periprocedural clinical outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System by a diverse group of clinicians.BackgroundThere is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels.MethodsThe study enrolled symptomatic (≥50% carotid artery stenosis) and asymptomatic (≥80% carotid stenosis) patients at high risk for carotid endarterectomy. Study centers were grouped into three tiers based on previous CAS experience while individual operators were grouped by their CAS training. The primary endpoint was the 30-day composite of major adverse events [MAEs; including stroke, death, and myocardial infarction (MI)]. Individual event rates were evaluated across the overall study, and by center experience and physician training tier.ResultsOf 1,097 enrolled patients, 1,025 were evaluable for 30-day MAE rate. The stroke rate (3.3%) was a major contributing factor in the overall MAE rate (4.6%). Mortality was 1.3% and the MI rate was 0.5%. There was no statistically significant association between MAE rates among the center experience tiers (P = 0.61) nor among the operator training categories (P = 0.26).ConclusionsCAS with the Carotid WALLSTENT and FilterWire EZ yielded a low 30-day MAE rate that did not differ significantly across operator experience and training levels. Clinicaltrials.gov identifier: NCT00741091. © 2014 Wiley Periodicals, Inc.