Postprocedural Clinical Outcomes Research Articles

Comparison of PROVISIONal 1-stent strategy with Drug-Eluting Balloon versus Planned 2-stent strategy in patients with Non-LM Coronary True-Bifurcation Lesions (PROVISION-DEB).

Percutaneous coronary intervention (PCI) for bifurcation lesions presents several difficulties and often results in suboptimal procedural, post-procedural clinical outcomes. While the provisional 1-stent strategy is generally favored for its simplicity and favorable outcomes, a few studies suggest no significant difference between 1-stent and 2-stent techniques for true bifurcation lesions. Drug-eluting balloons (DEBs) have demonstrated potential in small vessel disease, including bifurcation side branches. However, no studies have compared the 2-stent strategy with the provisional 1-stent plus DEB strategy in non-LM true bifurcation lesions. Our study aims to address this gap by comparing these strategies, with a focus on real-world practice and detailed endpoint analysis. The PROVISION-DEB study is an open-label, randomized, multi-center clinical trial designed to investigate noninferiority and compare a 1-stent strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation lesions. A total of 750 patients with de novo non-LM coronary bifurcation lesions undergoing coronary interventions will be randomized 1:1 to either a provisional 1-stent plus DEB strategy or a 2-stent strategy with stratified Diabetes. The primary endpoint is a target lesion failure, composite outcome of cardiac death, target vessel myocardial infarction, or target lesion revascularization at the anticipated 3 years follow-up (6, 12, and 36 months). In conclusion, PROVISION-DEB study is a randomized, multi-center, non-inferior clinical trial and will compare a 1-setnt strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation.

Single beta-blocker or combined amiodarone therapy in ICD and CRT-D patients - Insights from the German DEVICE-registry

Abstract Background Because of its antiarrhythmic potency and due to the lack of alternatives, amiodarone is often used for antiarrhythmic therapy in patients with ICD or CRT-D systems. To date, robust data on the safety and clinical benefit of amiodarone therapy in these patients are missing. Objective This study was designed to assess the periprocedural and post-procedural outcome of combined therapy with beta-blockers plus amiodarone compared to treatment with single beta-blockers in this "real life" cohort of ICD recipients of the German DEVICE registry. Methods 4,499 patients who underwent ICD implantation, revision, or upgrade in 49 centers participating in the German DEVICE Registry were enrolled 03/2007-02/2014. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, were analyzed. Results 12.7 % (572 patients) received amiodarone in addition to beta-blocker therapy. These patients were slightly older and more frequently male than the 3,927 patients with sole betablocker therapy. The two cohorts of patients had no relevant differences in terms of underlying cardiomyopathy. Stroke, and chronic kidney disease were more often present in the patient group receiving amiodarone. Early implantation-associated complications were similar between the groups. One-year overall mortality was, however, significantly higher in the beta-blocker plus amiodarone cohort (adjusted HR 2.09; p<0.001). This was particularly pronounced in the subgroups of patients with sinus rhythm or severely reduced left ventricular function. Interestingly, amongst the surviving patients, amiodarone was not associated with a significantly reduced risk of ICD discharges, syncopal events. Further, the occurrence of VT storm or incessant VTs and the number of patients scheduled for intracardiac ablation did not differ among both groups while the rate of rehospitalization was lower in the cohort with sole beta-blockers. Conclusions Taken together, these retrospective "real-word" data suggest an increased all-cause mortality under amiodarone therapy, particularly in the subgroups of patients with sinus rhythm or severely reduced left ventricular function. In surviving patients, rates of arrhythmic events were comparable.Abstract Figure

CT-guided radiofrequency ablation of painful intra-articular osteoid osteoma in children: Is there a concern for cartilage damage?

To evaluate the safety and efficacy of computed tomography-guided percutaneous radiofrequency ablation (PRFA) in the management of uncommon and technically challenging intra-articular osteoid osteoma in children. From December 2018 to September 2022, 16 children with intra-articular osteoid osteoma, including ten boys and six girls, were treated at two tertiary centers with percutaneous CT-guided RF ablation using a straight monopolar electrode. The procedures were carried out under general anesthesia. Post-procedural clinical outcomes and adverse events were assessed through clinical follow-up. Technical success was achieved in all of the participating patients. Clinical success with relief of symptomatology throughout the period of follow-up was achieved in 100% of the patients. No persistence or recurrence of pain occurred during the follow-up period. No immediate or delayed adverse effects were observed. PRFA is shown to be technically feasible. Clinical improvement can be achieved with a high rate of success in the treatment of children with difficult-to-treat intra-articular osteoid osteomas.

Assessing the Learning Curve for DMEK Using Post-Procedural Clinical Outcomes-Comparison of Four Different Surgeons during Two Different Periods.

Evaluating the learning curve of individual surgeons for Descemet Membrane Endothelial Keratoplasty (DMEK) and Triple-DMEK and assessing outcome with experience. The first 41 and the last 41 surgeries of each of the four surgeons were retrospectively included. Surgery duration and graft preparation time were recorded. Corrected distance visual acuity (CDVA, logMAR) and central corneal thickness (CCT, µm) were collected preoperatively after 6 and 12 months, as well as postoperative complications, e.g., re-bubbling or repeat penetrating keratoplasty. Surgical duration for Triple-DMEK and DMEK decreased significantly by 21 min and 14 min between the two periods (p < 0.001; p < 0.001). Graft preparation time decreased significantly from 13.3 ± 5.2 min (95%CI 12.8-14.3) in period 1 to 10.7 ± 4.8 min (95%CI 10.2-11.4) in period 2 (p = 0.002). The postoperative changes in CDVA and CCT over both periods were not significant (p = 0.900; p = 0.263). The re-bubbling rate decreased significantly from 51.2% in period 1 to 26.2% in period 2 (p < 0.001). The repeat penetrating keratoplasty (PKP) was 7.3% in period 1 and 3.7% in period 2 (p = 0.146). Re-DMEK was necessary in 6.1% in period 1 and 4.9% in period 2 (p = 0.535). Several parameters showed significant differences between the surgeons in both periods (surgical duration: period 1: p < 0.001, period 2 p < 0.001; graft preparation: period 1: p < 0.001, period 2 p < 0.001). Significant decrease in surgery duration, graft preparation time, and the re-bubbling rate can be attributed to gained individual experience.

Does the Absence of Contrast Passage Into the Duodenum During Intraoperative Cholangiogram Truly Predict Choledocholithiasis?

Background and AimsThe absence of contrast passage to the duodenum is frequently encountered during an intraoperative cholangiogram (IOC), and patients with this finding are suspected of having choledocholithiasis. This study was conducted to determine the positive predictive value (PPV) of the absence of contrast passage during IOC and identify predictors, if any, that increase the pretest probability of choledocholithiasis in these patients. MethodsAll laparoscopic cholecystectomies with IOCs between September 1, 2019, and September 1, 2021, at a tertiary medical center were reviewed to identify those with abnormal cholangiograms due to only the lack of contrast passage to the duodenum. Patient demographic information, pre- and postoperative laboratory results, and radiographic studies were recorded. Postprocedural clinical outcomes including endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) findings were tabulated to determine the presence of choledocholithiasis. Patient factors and outcomes were compared between a cohort that was found to have choledocholithiasis vs those who were not. Finally, multiple logistic regression was performed to identify predictors of choledocholithiasis. ResultsOf 320 IOCs, 31(9.7% of all abnormal IOCs) showed the lack of contrast passage in the duodenum as the only abnormality. The PPV of an IOC with the lack of contrast in the duodenum was 29%. Preoperative bilirubin levels, postoperative aspartate aminotransferase levels, and postoperative alanine transaminase levels were significant predictors of choledocholithiasis in this group of patients. ConclusionsThe lack of contrast passage to the duodenum as the sole finding of an abnormal IOC has poor PPV for choledocholithiasis. Thus, it is reasonable to consider using less invasive modalities such as EUS and/or magnetic resonance cholangiopancreatography before ERCP in these patients.

Clinical outcomes in patients undergoing complex, high-risk percutaneous coronary intervention and haemodynamic support with intra-aortic balloon versus Impella pump: Real-life single-centre preliminary results.

Patients and mechanical circulatory support assortment, as well as periprocedural and post-procedural clinical outcomes in complex high-risk percutaneous coronary interventions (PCIs) underpinned by percutaneous left ventricular assist devices (pLVAD) are the subject of debate. The study aimed to identify differences between patients qualified for complex high-risk PCIs with an intra-aortic balloon pump (IABP) or Impella pump support and to compare peri- and post-procedural clinical outcomes. The presented analysis is a single-center study, which comprised consecutive patients undergoing complex high-risk PCIs performed with the pLVAD, either IABP or Impella. Patients included in the current analysis were recruited between January 2018 and December 2021. There were 28 (56%) patients in the Impella group and 22 (44%) in the IABP group. The primary endpoints included overall mortality and major adverse cardiovascular events (MACE) such as all-cause mortality, myocardial infarction, revascularization, and cerebrovascular events. Patients from the IABP group were significantly older, had higher left ventricular ejection fraction (LVEF), and less frequent history of PCI, while the in-hospital risk of death assessed by EuroSCORE II remained similar in the Impella and IABP groups (median interquartile range [IQR] 2.8 [2-3.8] vs. 2.5 [1.8-5.2]; P = 0.73). Patients undergoing complex high-risk PCIs with pLVAD support presented similar results during the follow-up, assessed by log-rank estimates in terms of MACE (P = 0.41) and mortality rate (P = 0.65). The use of pLVAD devices in patients undergoing complex high-risk PCIs, with reduced left ventricular ejection fraction, is a promising treatment option for patients disqualified from surgery by cardiac surgeons.

Clinical outcomes of image-guided percutaneous drainage of pericardial effusion in cancer patients: A single-center retrospective analysis.

Catheter removal, survival, and recurrence rates after percutaneous pericardial effusion drainage in cancer patients are not fully understood. We evaluated the clinical outcomes of image-guided percutaneous pericardial effusion drainage in cancer patients. From January 2014 to September 2017, 113 percutaneous drainages for symptomatic pericardial effusion were performed in 100 cancer patients (median 60 years; range, 7-84 years) using ultrasound or angio-computed tomography. An 8-Fr drainage catheter was placed using the Seldinger technique via the subxiphoid (n=73), apical (n=23), or left parasternal (n=17) routes. Success rates, complications, and postprocedural clinical outcomes of drainages were retrospectively assessed. The technical and clinical success rates were 100% and 99%, respectively, without major complications. The median duration of catheterization and evacuated pericardial effusion volume were 6 days (range, 1-72 days) and 970ml (range, 140-7635ml), respectively. Catheters were removed after the first drainage in 86 cases (86%). Symptomatic pericardial effusion recurred in nine patients after catheter removal, in whom redrainages were performed 13 times with a median duration to redrainage time of 48 days (range, 13-529 days). During the follow-up period (median 106 days [range, 1-1396 days]), 61 patients died. The median survival was 140 days (95% confidence interval [CI], 95-276 days), and the median catheter-free survival was 111 days (95% CI, 60-152 days). Image-guided percutaneous pericardial effusion drainage for cancer patients is safe and helps alleviate symptoms. Additionally, catheter removal is possible in most patients, allowing a catheter-free period for patients.

A single-center experience of anterior accessory saphenous vein endothermal ablation demonstrates safety and efficacy

ObjectiveEndothermal ablation is well-established for the treatment of the great and small saphenous veins. Data are lacking for treatment of the anterior accessory saphenous vein (AASV). The purpose of this study was to evaluate the safety and efficacy of AASV treatment using endothermal ablation. MethodsThis retrospective review included 314 limbs at a single academic institution from 2016 to 2018 using the institutional Vascular Quality Initiative database. All limbs had documented AASV reflux. Baseline characteristics were evaluated including age; sex; ethnicity; clinical, etiology, anatomy, pathophysiology classification; Venous Clinical Severity Score (VCSS); and vein diameter. Outcomes relating to procedure safety and efficacy included treatment modality and length, successful ablation on postoperative imaging, postprocedural clinical outcomes, incidence of endothermal heat-induced thrombosis (EHIT), and any postprocedural complication. ResultsA total of 314 consecutive limbs were identified from 2016 to 2018. The preprocedure VCSS scores were available for 312 limbs and averaged 6.13 ± 3.33. A history of varicose veins were reported in all limbs with 49.4% (n = 155) having previously undergone a procedure. The most common presenting symptom was mild edema in 52.5% (n = 165). Vein diameter and assessment of reflux were obtained by venous duplex ultrasound (DUS) examination. The largest AASV diameter was available for 304 limbs, averaging 7.93 ± 2.69 mm. Treatment modalities included radiofrequency ablation (RFA) in 59.2% (n = 186), endovenous laser ablation (EVLA) in 37.9% (n = 119), and isolated microphlebectomy in 2.9% (n = 9). In all, 38.5% (n = 121) of limbs underwent concomitant microphlebectomy at the time of EVLA. The total treatment length was obtained in 297 limbs, averaging 23.0 cm ± 12.0. Postoperatively, 94.6% of limbs (n = 297) were prescribed compression stockings. Postoperative DUS examination was performed in 312 limbs, revealing successful ablation in 96.5% (n = 303) with 2 limbs (0.6%) developing an EHIT, both treated with therapeutic enoxaparin for 1 week. Repeat DUS examination revealed thrombus resolution in one limb; the other patient was lost to follow-up. VCSS scores after the procedure were available for 145 limbs and averaged 4.45 ± 2.31. This was a statistically significant decrease from preprocedure VCSS scores (P < .01). Average duration of follow-up was 2.2 years, with two limbs lost to follow-up. Of the nine limbs (3.5%) whose initial procedure failed, five (56%) were treated using RFA and four (44%) were treated using EVLA. There were no other postoperative complications. ConclusionsOur experience over a 3-year period for treating the AASV shows it to be safe and effective in a broad range of disease severity with an improvement in VCSS and a low incidence of EHIT. Additionally, RFA and EVLA exhibit similar treatment efficacy. Long-term follow-up data are needed.

Short term outcomes of rotational atherectomy versus orbital atherectomy in patients undergoing complex percutaneous coronary intervention: a systematic review and meta-analysis

Objective Coronary artery calcification (CAC) is one of the paramount hurdles for percutaneous coronary intervention (PCI) since it impedes stent delivery and complete expansion. This study intended to evaluate the short-term clinical and procedural outcomes comparing rotational atherectomy (RA) and orbital atherectomy (OA) in patients with heavily calcified coronary lesions undergoing PCI. Design: This systematic review and meta-analysis included all head-to-head published comparisons of coronary RA versus OA. Procedural endpoints and post-procedural clinical outcomes (30 days/in-hospital), were compared. RevMan 5.3 software was used for data analysis. Results: Seven retrospective observational investigations with a total of 4623 patients, including 3203 patients in the RA group and 1420 patients in the OA group, were incorporated. Compared with OA, the RA group was associated with a higher incidence of myocardial infarction at short-term follow-up (OR: 1.56, 95% CI: 1.07–2.29, p = .02, I 2 = 0%). No difference was noted among other short-term post-procedural clinical outcomes including all-cause mortality, target vessel revascularization, or major adverse cardiac events. Among procedural complications, RA was associated with reduced coronary artery dissection and arterial perforation. Increased fluoroscopy time was observed in the RA cohort as compared with OA (MD: 4.78, 95% CI: 2.25–7.30, p = .0002, I 2 = 80%). Conclusion: RA was associated with fewer vascular complications, but at a cost of higher incidence of myocardial infarction and higher fluoroscopy time compared with OA, at short term follow-up. OA is a safe and effective alternative for the management of CAC.

Abstract 15774: Site Variation and Early Outcomes for Coronary Revascularization in Patients Undergoing TAVR in Northern New England

Introduction: It is unclear whether or not percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) yields an incremental benefit to patients with concomitant coronary artery disease (CAD). Hypothesis: We hypothesized that unprotected left main (LM) or proximal left anterior descending artery (pLAD) PCI conducted prior to TAVR is not associated with improved post-procedural clinical outcomes in a Northern New England patient population. Methods: We performed a retrospective study of 2,729 patients undergoing TAVR at 6 medical centers in Northern New England from 2012-2018. From this cohort, we identified patients with unprotected LM &gt;50% and/or pLAD &gt;70% CAD (n=160). We analyzed site variability and compared early outcomes of patients who underwent PCI ≤60 days before TAVR to those who did not. Results: Across 6 hospitals, there was significant variation in the use of PCI before TAVR (range 50%-76%, p for trend=0.361); this variation did not correlate with site TAVR volumes. In this 160 patient cohort, 36.2% had isolated LM&gt;50% and 76% had pLAD&gt;70% disease. The comparator groups were well-matched with respect to age, sex, and medical complexity. There were no significant differences between PCI and non-PCI groups with respect to early mortality, MI, or stroke after TAVR (Table). Conclusion: There is significant variation in revascularization practices before TAVR. The routine performance of unprotected LM or pLAD PCI before TAVR does not affect early post-valve outcomes in patients of Northern New England.

Transjugular intrahepatic portosystemic shunt and splenectomy are more effective than endoscopic therapy for recurrent variceal bleeding in patients with idiopathic noncirrhotic portal hypertension.

BACKGROUNDTransjugular intrahepatic portosystemic shunt (TIPS), splenectomy plus esophagogastric devascularization (SED) and endoscopic therapy + non-selective β-blockers (ET + NSBB) are widely applied in secondary prevention of recurrent gastroesophageal variceal bleeding in patients with liver cirrhosis. These different treatments, however, have not been compared in patients with idiopathic non-cirrhotic portal hypertension (INCPH).AIMTo compare the outcomes of TIPS, SED and ET + NSBB in the control of variceal rebleeding in patients with INCPH.METHODSThis retrospective study recruited patients from six centers across China. Demographic characteristics, baseline profiles and follow-up clinical outcomes were collected. Post-procedural clinical outcomes, including incidence of rebleeding, hepatic encephalopathy (HE), portal vein thrombosis (PVT) and mortality rates, were compared in the different groups.RESULTSIn total, 81 patients were recruited, with 28 receiving TIPS, 26 SED, and 27 ET + NSBB. No significant differences in demographic and baseline characteristics were found among these three groups before the procedures. After treatment, blood ammonia was significantly higher in the TIPS group; hemoglobin level and platelet count were significantly higher in the SED group (P < 0.01). Rebleeding rate was significantly higher in the ET + NSBB group (P < 0.01). Mortality was 3.6%, 3.8% and 14.8% in the TIPS, SED and ET + NSBB groups, respectively, with no significant differences (P = 0.082). Logistic regression analysis showed that mortality was significantly correlated with rebleeding, HE, portal thrombosis and superior mesenteric vein thrombosis (P < 0.05).CONCLUSIONIn patients with INCPH, TIPS and SED were more effective in controlling rebleeding than ET + NSBB, but survival rates were not significantly different among the three groups. Mortality was significantly correlated with rebleeding, HE and PVT.

Randomized trial of intracoronary adenosine as adjunctive therapy for prevention of the no-reflow phenomenon.

No-reflow phenomenon as a serious complication following percutaneous coronary intervention, deteriorates clinical outcomes. Intracoronary (IC) Adenosine, seems to be a way to deal with it. One hundred four consecutive patients with ST-segment elevation myocardial infarction were randomized into two groups. Each group consisted of 52 patients who managed with two bolus doses of IC Adenosine (Adenosine group) or two bolus doses of IC normal saline (placebo group) administered before and after stenting. Thrombolysis in myocardial infarction (TIMI) grade flow, ST-segment resolution (STR) and post-procedural clinical outcomes were used as endpoints. IC adenosine led to lower rates of no-reflow based on TIMI grade flow scaling (15.4% vs. 44.3%; P-value: 0.02). STR classified as complete, partial and no resolution was similar between two groups (P-value: 0.748). Also, post-interventional clinical outcomes, including arrhythmia, left ventricular ejection fraction, hospitalization time, and 30 days mortality were similar between Adenosine and placebo groups.

Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry.

AimsDiabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation.Methods and resultsWithin the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post‐procedural clinical outcome, including a composite clinical endpoint of all‐cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow‐up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non‐DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non‐DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non‐DM patients. Unadjusted and adjusted analyses revealed similar all‐over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan–Meier survival analysis showed higher all‐cause mortality after 1 year (9.0% vs 6.3%; log‐rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non‐DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89‐1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68–2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9–5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42–1.28)].ConclusionsThe overall risk of periprocedural complications and short‐term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT‐D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT‐D implantation.

Resection of the gastric submucosal tumor (G-SMT) originating from the muscularis propria layer: comparison of efficacy, patients\u2019 tolerability, and clinical outcomes between endoscopic full-thickness resection and surgical resection

Background and aimsEndoscopic full-thickness resection (EFTR) has been increasingly applied in the treatment of gastric submucosal tumors (G-SMTs) with explorative intention. This study aimed to compare the efficacy, tolerability, and clinical outcomes of EFTR and surgical intervention for the management of muscularis propria (MP)-derived G-SMTs.MethodsBetween September 2011 and May 2019, the clinical records of patients with MP-derived G-SMTs undergoing EFTR at our endoscopic unit were collected. A cohort of people with primary MP-derived G-SMTs treated by surgery was matched in a 1:1 ratio to EFTR group with regard to patients’ baseline characteristics, clinicopathologic features of the tumor and the procedure date. The perioperative outcomes and follow-up data were analyzed.ResultsIn total, 62 and 62 patients were enrolled into the surgery and EFTR group, respectively, with median follow-up of 786 days. The size of G-SMTs (with ulceration) ranged from 10 to 90 mm. For patients with tumor smaller than 30 mm, surgery and EFTR group presented comparable procedural success rate (both were 100%), en bloc resection rate (100% vs. 94.7%), tumor capsule rupture rate (0% vs. 5.3%), and pathological R0 resection rate (both were 100%). EFTR had a statistically significant advantage over surgery for estimated blood loss (3.12 ± 5.20 vs. 46.97 ± 60.73 ml, p ≤ 0.001), discrepancy between the pre- and postprocedural hemoglobin level (5.18 ± 5.43 vs. 9.84 ± 8.25 g/L, p = 0.005), bowel function restoration [1 (0–5) vs. 3 (1–5) days, p ≤ 0.001], and hospital cost (28,617.09 ± 6720.78 vs. 33,963.10 ± 13,454.52 Yuan, p = 0.033). The patients with tumor larger than 30 mm showed roughly the same outcomes after comparison analysis of the two groups. However, the clinical data revealed lower en bloc resection rate (75.0% vs. 100%, p = 0.022) and higher tumor capsule rupture rate (25.0% vs. 0%, p = 0.022) for EFTR when compared to surgery. The procedure time, duration of postprocedural fasting and antibiotics usage, and hospital stay of the two groups were equivalent. The occurrence rate of adverse events within postoperative day 7 were 74.2% and 72.6% after EFTR and surgery, respectively (p = 1.000). No complications occurred during the follow-up.ConclusionFor treatment of MP-derived G-SMTs (with or without ulceration), our study showed the feasibility and safety of EFTR, which also provided better results in terms of procedural blood loss, the postoperative bowel function restoration and cost-effectiveness when compared to surgery, whereas the surgery was superior in en bloc resection rate for G-SMTs larger than 30 mm. The postprocedural clinical outcomes seemed to be equivalent in these two resection methods.

Percutaneous Treatment of Carotid Artery Stenoses with Stents: A Single Center Experience

Objectives &#x0D; The effectiveness of carotid artery stenting (CAS) for primary and secondary prevention of ischemic stroke has been demonstrated in many studies. In this study, we aimed to present the characteristics and post-procedural clinical outcomes of the patients admitted to our clinic with severe carotid artery disease and revascularized by carotid artery stenting (CAS) with distal embolic protection system.&#x0D; &#x0D; Methods&#x0D; This study was a single- center retrospective study. Between Jan 2015 and May 2017 patients undergoing CAS procedure were included in the study. Symptomatic cases with more than 50% stenosis and asymptomatic patients with more than 70% stenosis were included in the study.&#x0D; Results&#x0D; Twenty-five patients were included in the study. 68% of patients were male with a mean age of 69.3 ± 15.7 years. 92% of patients were symptomatic. In all patients, distal embolic protection devices and self-expandable carotid stents were used. All procedures were performed successfully. No mortality or myocardial infarction was observed in any of the patients in whom CAS was applied successfully. Five complications were seen related to the procedure. One patient had air embolism, one patient had transient ischemic attack, one patient had stroke, one patient had symptomatic nodal rhythm and the last patient had hyper-perfusion syndrome.&#x0D; Conclusion&#x0D; CAS is being successfully applied with acceptable complication rates in experienced centers.

Delirium After Transcatheter Aortic Valve Implantation Under General Anesthesia: Incidence, Predictors, and Relation to Long-Term Survival.

BACKGROUND/OBJECTIVESProspectively collected data on postoperative delirium (POD) after transcatheter aortic valve implantation (TAVI) are scarce. The aim of this study was to report the incidence and risk factors of delirium after TAVI under general anesthesia and to assess the association of POD with clinical outcome and short‐ and long‐term survival.DESIGNProspective cohort study.SETTINGAcademic medical center.PARTICIPANTSA total of 703 subsequent patients undergoing TAVI under general anesthesia between 2008 and 2017.MEASUREMENTSDelirium was assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM‐IV), criteria. Outcomes were postprocedural clinical outcome and short‐ and long‐term survival (30 days and 5 years, respectively).RESULTSPOD was observed in 16.5% (116/703), was the strongest independent predictor of long‐term mortality (hazard ratio = 1.91; 95% confidence interval [CI] = 1.36‐2.70), and was associated with impaired 30‐day and 5‐year survival (92.2% vs 96.8% [P = .025] and 40.0% vs 50.0% [P = .007], respectively). Stroke and new onset of atrial fibrillation were more often observed in delirious patients (6.9% vs 1.9% and 12.1% vs 5.1%, respectively). Strongest independent predictors of POD were prior delirium (odds ratio [OR] = 2.56; 95% CI = 1.52‐4.31) and aortic valve area less than 0.75 cm2 (OR = 2.39; 95% CI = 1.53‐3.74).CONCLUSIONOne in six patients experienced POD after TAVI under general anesthesia. POD was the strongest predictor of long‐term mortality and was associated with impaired short‐ and long‐term survival. Prior delirium and a more calcified aortic valve were the strongest independent predictors of POD. J Am Geriatr Soc 67:2325–2330, 2019

Aortic Angulation Does Not Impact Outcomes in Self-Expandable or Balloon-Expandable Transcatheter Aortic Valve Replacement

Objectives: The role of aortic angulation in attenuating procedural success in balloon-expandable (BE) and self-expandable (SE) transcatheter aortic valve replacement (TAVR) has been controversial. Methods: We retrospectively assessed patients undergoing SE and BE TAVR who had an aortic angle measured on multidetector computed tomography at a single tertiary referral center. The primary outcome was device success, measured per the Valve Academic Research Consortium-2 criteria. Clinical outcomes at 30 days (including mortality) were also assessed. Results: A total of 251 patients were identified; 182 patients received a BE valve and 69 patients an SE valve. The median aortic angle was 46.8° (range 24.4–70°) in the BE group and 43.3° (range 20–71°) in the SE group. In multivariate logistic regression analysis, aortic angulation did not affect device success. Mortality at 30 days and 12 months and postprocedural clinical outcomes were similarly not associated with aortic angulation. Conclusion: In this cohort of patients undergoing BE and SE TAVR over a wide range of aortic angles, we found no associations between angle and device success or any other clinical metrics. Increased aortic angulation does not adversely affect outcomes in BE or SE TAVR.

Vena Cava Filter Retrieval with Aorto-Iliac Arterial Strut Penetration.

To evaluate the safety and technical success of inferior vena cava (IVC) filter retrieval in the setting of aorto-iliac arterial strut penetration. IVC filter registries from six large United States IVC filter retrieval practices were retrospectively reviewed to identify patients who underwent IVC filter retrieval in the setting of filter strut penetration into the adjacent aorta or iliac artery. Patient demographics, implant duration, indication for placement, IVC filter type, retrieval technique and technical success, adverse events, and post procedural clinical outcomes were identified. Arterial penetration was determined based on pre-procedure CT imaging in all cases. The IVC filter retrieval technique used was at the discretion of the operating physician. Seventeen patients from six US centers who underwent retrieval of an IVC filter with at least one strut penetrating either the aorta or iliac artery were identified. Retrieval technical success rate was 100% (17/17), without any major adverse events. Post-retrieval follow-up ranging from 10 days to 2 years (mean 4.6 months) was available in 12/17 (71%) patients; no delayed adverse events were encountered. Findings from this series suggest that chronically indwelling IVC filters with aorto-iliac arterial strut penetration may be safely retrieved.

Stent-Assisted Coiling of Wide-Neck Intracranial Aneurysms Using Low-Profile LEO Baby Stents: Initial and Midterm Results.

Low-profile self-expandable stents were recently introduced for the treatment of wide-neck intracranial aneurysms. This study investigated the initial and midterm clinical and angiographic results of LEO Baby stent-assisted coiling in the treatment of wide-neck intracranial aneurysms. A retrospective review was performed to identify patients who were treated with LEO Baby stent-assisted coiling. Eighty patients with 80 wide-neck intracranial aneurysms were included in the study. Eleven patients (13.8%) presented with subarachnoid hemorrhage. All patients were treated with LEO Baby stent-assisted coiling. Technical success and immediate postprocedural clinical and angiographic outcomes were evaluated. Seventy-three patients attended angiographic and clinical follow-up for a mean duration of 7.2 ± 3.8 months. Periprocedural and delayed complications were reviewed. Preprocedural and follow-up clinical statuses were assessed by using the modified Rankin Scale. The technical success rate of the procedure was 97.5%. The immediate postprocedural angiography revealed a complete occlusion of the aneurysm in 75% of the 80 patients. The last follow-up angiograms showed complete occlusion in 85.7% of the 77 patients with an angiographic follow-up. Of the 77 patients with a follow-up angiography, 6.5% showed an increase in the filling status of the aneurysm and 5.2% required retreatment. The overall procedure-related complication rate, including asymptomatic complications, was 11.3%. The permanent morbidity rate was 3.8%. There was no mortality in this study. This case series demonstrates the relative safety, efficacy, and midterm durability of the LEO Baby stent-assisted coiling procedure for the treatment of wide-neck intracranial aneurysms.

Early and late clinical outcomes of endovascular, surgical, and hybrid revascularization strategies of combined carotid and coronary artery diseases: the FRIENDS study group (Finalized Research In ENDovascular Strategies)

The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. The aim of the study is to observe post-procedural and 1-year clinical outcomes of patients with COD and CAD after an endovascular, surgical, or a combined (hybrid) revascularization approach, selected by consensus of a multidisciplinary team. Between January 2006 and December 2012, 1043 consecutive patients with COD and concomitant CAD were treated. According to treatment strategies, patients were divided into three groups: surgical: 391 patients (37.1%), endovascular: 502 (48.1%), and hybrid (combined surgical and percutaneous revascularization): 129 (12.4%). The remaining 21 patients were managed medically only and not analysed. The primary end point of the study was a composite of death, myocardial infarction (MI), and stroke at 1-year follow-up; secondary end points included a composite of death, MI, and stroke in-hospital, and major bleeding complications. In hospital, mortality was higher in the surgical group (2.3 vs. 0.2 and 0%, P < 0.001), more strokes occurred in the endovascular group (2.0 vs. 0.5 and 0.8%, P = 0.03), and major bleedings were more frequent among hybrid patients (13.9 vs. 3.8 and 5.5%, P = 0.001). The incidence rate of the primary end point (hierarchical at 1 year) occurred in 6.0% of the study population (5.8, 6.5, and 4.6%, respectively; P = ns for all groups). Surgical and endovascular treatments yield remarkable clinical results both at acute and 1-year follow-up. The best-suited revascularization strategy should be discussed in a multidisciplinary context, and chosen according to the clinical characteristics of each single case and local expertise.