Mortality and Major Adverse Events Improve With Increased Institutional Experience for Fenestrated and Branched Endovascular Aortic Repair

2021 ◽  
pp. 152660282110648
Author(s):  
Robert-James Doonan ◽  
Saad Bin-Ayeed ◽  
Philippe Charbonneau ◽  
Kiattisak Hongku ◽  
Kent Mackenzie ◽  
...  

Objective: Our objective was to evaluate temporal trends in outcomes at our institution in the context a more heterogenous application of fenestrated/branched endovascular aneurysm repair (F/BEVAR). Methods: Patient and aneurysm characteristics, procedure details, and postoperative outcomes were collected for consecutive patients undergoing F/BEVAR between 2002 and February 2019 at our institution. Outcomes were compared between tertile 1 (T1, 2002–2010, n=47), T2 (2011–2014, n=47), and T3 (2015-February 2019, n=47). Results: We included 141 patients (74.8 ± 8.1 years, 83% male) with a mean follow-up of 28.0 ± 31.6 months. Proportion of patients with hypertension (63.8% T1, 85.1% T3, p=0.009), diabetes (6.4% T1, 29.7% T3, p=0.005), chronic obstructive pulmonary disease (COPD; 27.6% T1, 42.5% T3, p=0.07), and history of stroke (4.2% T1, 17% T3, p=0.07) increased over time. Aneurysm diameter (65.3±11.4mm) and extent (56.0% juxtarenal/pararenal, 22.0% type IV, 22.0% type I-III) did not differ between groups. Custom made devices were implanted in 96.5% of cases with 3.4 ± 0.7 vessels reimplanted/case. There was a trend toward increased history of aortic surgery (p=0.008) and less custom made devices (p=0.007) in T3. Total procedure time (383.5±119.2 minutes T1, 316.2±88.4 T3, p=0.02), contrast volume (222.8±109.1 mL T1, 139.2±62.7ml T3, p<0.0001), and estimated blood loss (601.3±458.1 mL T1, 413.3±317.7 mL T3, p=0.02) decreased over time. Overall 30-day mortality was 6.3%, 10.6%-T1, 6.3%-T2, and 2.1%-T3 (p=0.09). We noted significant improvement in survival over time; 1- and 3-year survival was 79% and 56%, 89% and 83%, and 90% and 90%, for T1, T2, and T3, respectively (p=0.007). In all, 467 of 480 target vessels were revascularized (97.3% success). Reintervention rate (30-day: 13.5%, follow-up: 34.7%) and reintervention free survival was not significantly different between groups. Any major adverse event (MAE) occurred in 36.9% of patients overall with a significant decrease from early (51.1%), mid (34.9%), to late in our experience (25.5%, p=0.03). In multivariate analyses, increasing institutional experience (T3), procedure time, age, and sex were independent predictors of major adverse events. Conclusion: We have shown improvement in F/BEVAR outcomes including mortality, MAEs, and procedural metrics with increasing institutional experience. We postulate that a combination of advancements in technique, surgical team and postoperative care experience, graft design and stent technologies, and patient selection contributed to improvement in outcomes.

Author(s):  
Georgina E. Sellyn ◽  
Alan R. Tang ◽  
Shilin Zhao ◽  
Madeleine Sherburn ◽  
Rachel Pellegrino ◽  
...  

OBJECTIVEThe authors’ previously published work validated the Chiari Health Index for Pediatrics (CHIP), a new instrument for measuring health-related quality of life (HRQOL) for pediatric Chiari malformation type I (CM-I) patients. In this study, the authors further evaluated the CHIP to assess HRQOL changes over time and correlate changes in HRQOL to changes in symptomatology and radiological factors in CM-I patients who undergo surgical intervention. Strong HRQOL evaluation instruments are currently lacking for pediatric CM-I patients, creating the need for a standardized HRQOL instrument for this patient population. This study serves as the first analysis of the CHIP instrument’s effectiveness in measuring short-term HRQOL changes in pediatric CM-I patients and can be a useful tool in future CM-I HRQOL studies.METHODSThe authors evaluated prospectively collected CHIP scores and clinical factors of surgical intervention in patients younger than 18 years. To be included, patients completed a baseline CHIP captured during the preoperative visit, and at least 1 follow-up CHIP administered postoperatively. CHIP has 2 domains (physical and psychosocial) comprising 4 components, the 3 physical components of pain frequency, pain severity, and nonpain symptoms, and a single psychosocial component. Each CHIP category is scored on a scale, with 0 indicating absent and 1 indicating present, with higher scores indicating better HRQOL. Wilcoxon paired tests, Spearman correlations, and linear regression models were used to evaluate and correlate HRQOL, symptomatology, and radiographic factors.RESULTSSixty-three patients made up the analysis cohort (92% Caucasian, 52% female, mean age 11.8 years, average follow-up time 15.4 months). Dural augmentation was performed in 92% of patients. Of the 63 patients, 48 reported preoperative symptoms and 42 had a preoperative syrinx. From baseline, overall CHIP scores significantly improved over time (from 0.71 to 0.78, p < 0.001). Significant improvement in CHIP scores was seen in patients presenting at baseline with neck/back pain (p = 0.015) and headaches (p < 0.001) and in patients with extremity numbness trending at p = 0.064. Patients with syringomyelia were found to have improvement in CHIP scores over time (0.75 to 0.82, p < 0.001), as well as significant improvement in all 4 components. Additionally, improved CHIP scores were found to be significantly associated with age in patients with cervical (p = 0.009) or thoracic (p = 0.011) syrinxes.CONCLUSIONSThe study data show that the CHIP is an effective instrument for measuring HRQOL over time. Additionally, the CHIP was found to be significantly correlated to changes in symptomatology, a finding indicating that this instrument is a clinically valuable tool for the management of CM-I.


2021 ◽  
pp. 112067212110053
Author(s):  
Moustafa Salamah ◽  
Ashraf Mahrous Eid ◽  
Hani Albialy ◽  
Sherif Sharaf EL Deen

Purpose: To compare the efficacy of two different suture types in levator plication for correction of congenital ptosis. Subjects and methods: Prospective comparative interventional randomized study involving 42 eyes of 42 patients aged more than 6 years with congenital ptosis and good levator action. The exclusion criteria were as follows: bilateral ptosis, history of previous surgery, fair or poor levator action, and associated other ocular diseases. Patients were randomized into group A, in which double-armed 5/0 polyester Ethibond were used, and group B, in which double-armed 5/0 Coated Vicryl® (polyglactin 910) suture material we used. Outcomes including eyelid height and stability of eyelid height over time were compared with follow-up data. The MRD was 4.05 ± 0.36 mm and 3.95 ± 0.34 after 1 week for both groups A and B, respectively. At the end of study follow up period (24 weeks), the MRD was 3.60 ± 0.42 mm in group A, and 2.52 ± 0.85 mm in group B. Conclusion: No difference in eyelid height between two groups in early postoperative period, but the postoperative eyelid height was more stable over time in the 5/0 polyester Ethibond group (group A) than in the 5/0 Coated Vicryl® (polyglactin 910) group (group B).


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Filippo Migliorini ◽  
Nicola Maffulli ◽  
Filippo Spiezia ◽  
Giuseppe Maria Peretti ◽  
Markus Tingart ◽  
...  

Abstract Background Biochemical markers of bone turnover (BTMs), such as the bone alkaline phosphatase (bALP), procollagen type I N propeptide (PINP), serum cross-linked C-telopeptides of type I collagen (bCTx), and urinary cross-linked N-telopeptides of type I collagen (NTx), are used to manage therapy monitoring in osteoporotic patients. This systematic review analyzed the potential of these BMTs in predicting the clinical outcomes in terms of BMD, t-score, rate of fractures, and adverse events during the therapy setting in postmenopausal osteoporosis. Methods All randomized clinical trials (RCTs) reporting data on biomarkers for postmenopausal osteoporosis were accessed. Only articles reporting quantitative data on the level of biomarkers at baseline and on the outcomes of interest at the last follow-up were eligible. Results A total of 36,706 patients were retrieved. Greater values of bALP were associated with a greater rate of vertebral (P = 0.001) and non-vertebral fractures (P = 0.0001). Greater values of NTx at baseline were associated with a greater rate of adverse events at the last follow-up (P = 0.02). Greater values of CTx at baseline were associated with a greater rate of adverse events leading to discontinuation (P = 0.04), gastrointestinal adverse events (P = 0.0001), musculoskeletal adverse events (P = 0.04), and mortality (P = 0.04). Greater values of PINP at baseline were associated with greater rates of gastrointestinal adverse events (P = 0.02) at the last follow-up. Conclusion The present analysis supports the adoption of BMTs during pharmacological therapy setting of patients suffering from osteoporosis. Level of evidence I, systematic review of RCTs


2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Jesse Manunga ◽  
Larissa I. Stanberry ◽  
Peter Alden ◽  
Jason Alexander ◽  
Nedaa Skeik ◽  
...  

Abstract Background Endovascular rescue of failed infrarenal repair (EVAR) has emerged as an attractive option to stent graft explantation. The procedure, however, is underutilized due to limited devices accessibility and the challenges associated with their implantation in this patient population. The purpose of this study was to report our outcomes and discuss our approach to rescuing previously failed infrarenal endovascular aneurysm repairs (EVAR) with fenestrated/branched endografts (f/b-EVAR). Methods A retrospective analysis of prospectively collected data of consecutive patients with failed EVAR rescued with f/b-EVAR at our institution from November 2013 to March 2019 was conducted. The study primary end point was technical success; defined as the implantation of the device with no type I a/b or type III endoleak or conversion to open repair. Secondary endpoints included major adverse events (MAEs), graft patency and reintervention rates. Results During this time, 202 patients with complex aortic aneurysms were treated with f/b-EVAR. Of these, 19 patients (Male: 17, mean age 79 ± 7 years) underwent repair for failed EVAR. The median time from failed repair to f/b-EVAR was 48 (30, 60) months. Treatment failure was attributed to stent graft migration in 9 (47.4%) patients, disease progression in 5 (26.3%), short initial neck in 3 (15.8%) and unable to be determined in 2 (10.5%). Three patients were treated urgently with surgeon modified stent graft. Technical success was achieved in 18 patients (95%), including two who had undergone emergent repair for rupture. Seventy-two targeted vessels (97.3%) were successfully incorporated. Sixteen (84.2%) patients required a thoracoabdominal repair to achieve a durable seal. Major adverse events (MAEs) occurred in 3 patients (15.7%) including paralysis and death in one (5.3%), compartment syndrome and temporary dialysis in another and laparotomy with snorkeling of one renal and bypass of the other in the third patient. Median (IQR) hospital length of stay was 3 (2, 4) days. Late reintervention, primary target vessel patency and primary assisted patency rates were 5.3%, 98.6% and 100%, respectively. Conclusion Implantation of f/b-EVAR in patients with failed previous EVAR is a challenging undertaking that can be performed safely with a high technical success and low reintervention rates.


Vascular ◽  
2021 ◽  
pp. 170853812110627
Author(s):  
Gino Gemayel GG ◽  
Michel Montessuit MM ◽  
Anouche Gemayel GA

Objectives We represent two cases of late proximal type I endoleak following EVAR with aneurysm expansion that were treated with a custom-made graft with inner branches. Methods Two patients of 87 and 82 years old were operated by EVAR 6 and 8 years ago for abdominal aortic aneurysm. Both had proximal type I endoleak with aneurysm sac expansion. Open surgery had a high risk, and a proximal aortic extension with a simple aortic cuff was not possible neither because previous EVAR grafts were already at the level of the renal arteries. A custom-made endograft with inner branches was planned as a fenestrated graft was not technically possible. Results We successfully treated both patients using a custom-made graft with four inner branches from Jotec (Cryolife, Kennesaw, GA). Three months’ follow-up CT scan did not show any endoleaks. All target vessels were patent with good conformability of the bridging stents. Conclusion The treatment of proximal type I endoleak using inner branches’ endografts is feasible. This novel technology might broaden the indications for complex aortic repair in a group of patients where fenestrated endografts are not possible.


2010 ◽  
Vol 76 (6) ◽  
pp. 599-605 ◽  
Author(s):  
Joshua D. Adams ◽  
Margaret C. Tracci ◽  
Sahir Sabri ◽  
Kenneth J. Cherry ◽  
John F. Angle ◽  
...  

Endoleaks are a frequent complication of thoracic endovascular aortic repair (TEVAR) and will likely increase in incidence with application of the technique to more complicated aortic anatomy and a wider range of thoracic aortic pathologies. Management generally consists of aggressive repair of Type I endoleaks; however, the natural history of Type I endoleaks after TEVAR remains largely unknown. The purpose of this study was to examine the incidence and characteristics of Type I endoleaks and to evaluate clinical outcomes of patients with Type I endoleaks after TEVAR. A single-center retrospective review was performed on all patients who underwent TEVAR over a 4-year period. Type I endoleaks were detected in 21 per cent (27 of 129) of patients on post-deployment aortography or CT angiography. During a mean follow-up of 750.63 ± 483 days, 59 per cent (16 of 27) closed spontaneously; 30 per cent (eight of 27) required secondary endovascular intervention; and 11 per cent (three of 27) have persisted with no increase in maximum aortic diameter. No patients have died or required open surgical conversion as a result of their Type I endoleak. Although accurate predictors of spontaneous resolution of Type I endoleaks have yet to be definitively characterized, our initial results suggest that it may be safe to observe small Type I endoleaks given that a large percentage resolve spontaneously and no endoleak-related deaths have occurred.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Rakesh Gopinathannair ◽  
Scott M Koerber ◽  
Krishna Akella ◽  
Dhanunjaya Lakkireddy

Background: The Amulet IDE trial is an ongoing, randomized, worldwide trial, enrolled but following patients with non-valvular atrial fibrillation (AF) at high risk of stroke. The study is comparing the safety and effectiveness of the Amplatzer™ Amulet™ left atrial appendage (LAA) Occluder to the Watchman device. At US sites, the implanting physicians only had experience with the Watchman device; therefore, up to three roll-in subjects with Amplatzer Amulet device implantation were permitted prior to randomization. The purpose of this analysis is to describe the peri-procedural outcomes for the roll-in cohort. Methods: Roll-in subjects met the same eligibility criteria and have the same data collection requirements as randomized subjects. Adverse events were adjudicated by an independent clinical events committee and LAA occlusion was assessed by an independent core laboratory based on the 45-day TEE. Major adverse events included all cause death, ischemic stroke, systemic embolism or device-/procedure-related events requiring open cardiac surgery or major endovascular intervention within 7 days post implant or hospital discharge, whichever is later. Results: From August 2016 to November 2018, 201 patients with non-valvular AF at high risk of stroke and bleeding were enrolled at 82 sites as roll-in subjects. Mean age was 74.2 ± 7.5 years and 62% of subjects were male. The Amplatzer Amulet device was successfully deployed in 99% of subjects. Major adverse events within 7 days or hospital discharge occurred in 2.5% of patients and included death (n=3), ischemic stroke (n=1) and vascular access site bleeding (n=1). The majority (79%) of patients were discharged on antiplatelet therapy only or no anti-thrombotic medication. TEE follow-up at the 45-day visit revealed adequate (≤ 5 mm jet) occlusion of the appendage in 98.9% (178/180) of patients. Device-related thrombus (DRT) was identified by the core laboratory in 6 patients (3%); no patient experienced a thrombo-embolic event. Conclusions: In the roll-in cohort, with implanting physicians having no prior experience using the Amplatzer™ Amulet™ device, there was a low rate of procedural complications and high rates of both implant success and adequate LAA sealing at follow up.


PEDIATRICS ◽  
1992 ◽  
Vol 89 (6) ◽  
pp. 1194-1198 ◽  
Author(s):  
Siegfried M. Pueschel ◽  
Francis H. Scola ◽  
John C. Pezzullo

This study was designed to investigate the natural history of atlantoaxial instability in individuals with Down syndrome and to determine whether significant changes in C1-C2 relationship are taking place over time. Although more than 400 patients with Down syndrome who are presently followed at the Child Development Center had cervical spine radiographic examinations in the past, only 141 patients who had serial radiological examinations and whose radiographs were available for reevaluation participated in this study. The results of our investigations revealed that there were only minor changes (1 to 1.5 mm) of atlanto-dens interval measurements over time in 130 (92%) patients with Down syndrome. Eleven patients (8%) had changes of atlanto-dens interval measurements between 2 and 4 mm over time; however, none of these patients had any clinical symptoms. The analyses of data obtained from several subgroups (males and females, various age groups, and patients with and without atlantoaxial instability) did not show any significant changes of atlanto-dens interval measurements of successively obtained radiographs. Our recommendations for and rationale of routine screening for atlantoaxial instability and follow-up examinations are discussed in detail.


Author(s):  
Mary C. Zanarini

At baseline, borderline patients reported higher rates of adult rape and physical assault by a partner than Axis II comparison subjects. Four risk factors were found to significantly predict whether borderline patients had an adult history of being a victim of physical and/or sexual violence before their index admission: female gender, a substance use disorder that began before the age of 18, childhood sexual abuse, and emotional withdrawal by a caretaker (a form of neglect). At six-year and 10-year follow-up, borderline patients reported higher rates of being verbally, emotionally, physically, and sexually abused or assaulted than did Axis II comparison subjects. However, each of these forms of abuse declined significantly over time. The clinical implications of these prevalence and predictive findings are discussed.


2002 ◽  
Vol 181 (2) ◽  
pp. 135-137 ◽  
Author(s):  
R. G. McCreadie ◽  
R. Padmavati ◽  
R. Thara ◽  
T. N. Srinivasan

BackgroundSpontaneous dyskinesia and parkinsonism have been reported in never-medicated patients with schizophrenia but there has been no previous study of the natural history of these conditions.AimsTo determine the prevalence of spontaneous dyskinesia and parkinsonism in a group of never-medicated, chronically ill patients with schizophrenia on two occasions separated by an 18-month interval.MethodDyskinesia was assessed by the Abnormal Involuntary Movements Scale using Schooler and Kane criteria for its presence; parkinsonism by the Simpson and Angus scale; and mental state by the Positive and Negative Syndrome Scale for schizophrenia.ResultsThirty-seven patients were examined on two occasions. Nine (24%) had dyskinesia on both occasions, 12 (33%) on one occasion and 16 (43%) on neither occasion. Twenty-one (57%) had dyskinesia on at least one occasion. Thirteen patients (35%) had parkinsonism on at least one occasion.ConclusionsSpontaneous dyskinesia and parkinsonism fluctuate over time. The former was found on at least one occasion in the majority of patients. It is an integral part ofthe schizophrenic disease process.


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