Device-related Death Research Articles

Asymptomatic Patients With Brugada ECG Pattern: Long-Term Prognosis From a Large Prospective Study.

Brugada syndrome poses significant challenges in terms of risk stratification and management, particularly for asymptomatic patients who comprise the majority of individuals exhibiting Brugada ECG pattern (BrECG). The aim of this study was to evaluate the long-term prognosis of a large cohort of asymptomatic patients with BrECG. Asymptomatic patients with BrECG (1149) were consecutively collected from 2 Italian centers and followed-up at least annually for 2 to 22 years. For the 539 asymptomatic patients (men, 433 [80%]; mean age, 46±13 years) with spontaneous type 1 documented on baseline ECG (87%) or 12-lead 24-hour Holter monitoring (13%), an electrophysiologic study (EPS) was proposed; for the 610 patients with drug-induced-only type 1 (men, 420 [69%]; mean age, 44±14 years), multiple ECGs and 12-lead Holter were advised in order to detect the occurrence of a spontaneous type-1 BrECG. Arrhythmic events were defined as sudden death or documented ventricular fibrillation or tachycardia. Median follow-up was 6 (4-9) years. Seventeen (1.5%) arrhythmic events occurred in the overall asymptomatic population (corresponding to an event-rate of 0.2% per year), including 16 of 539 (0.4% per year) in patients with spontaneous type-1 BrECG and 1 of 610 in those with drug-induced type-1 BrECG (0.03% per year; P<0.001). EPS was performed in 339 (63%) patients with spontaneous type-1 BrECG. Patients with spontaneous type-1 BrECG and positive EPS had significantly higher event rates than patients with negative EPS (7 of 103 [0.7% per year] versus 4 of 236 [0.2% per year]; P=0.025). Among 200 patients who declined EPS, 5 events (0.4% per year) occurred. There was 1 device-related death. The entire population of asymptomatic patients with BrECG exhibits a relatively low event rate per year, which is important in view of the long life expectancy of these young patients. The presence of spontaneous type-1 BrECG associated with positive EPS identifies a subgroup at higher risk. Asymptomatic patients with drug-induced-only BrECG have a minimal arrhythmic risk, but ongoing follow-up with 12-lead Holter monitoring is recommended to detect the appearance of spontaneous type-1 BrECG pattern.

Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism.

Evidence supporting interventional pulmonary embolism (PE) treatment is needed. We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement. Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001). Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.

Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes.

This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE). Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus. The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6months. Follow-up imaging was planned for 45days and 6 and 12months. A total of 15 patients (age 71.3 ± 10.8 years, 33% men, CHA2DS2-VASc 4.1 ± 1.7, HAS-BLED 3.4 ± 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak≤5mm) in all patients; device-related thrombus was detected in 1 patient at 6months. Over 1-year follow-up, there were no ischemic strokes and 1minor bleed. Nonprocedure-/device-related death occurred in 2 patients. This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasiblewith encouraging 1-year clinical outcomes. (The Conformal Prague Study; NCT04193826).

Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database.

PurposeTo characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.Patients and MethodsWe conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST).ResultsFrom a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST.ConclusionMalfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

Abstract 16623: Interim Acute and 30-day Results of the Flash Registry

Introduction: FLASH, a prospective multi-center all-comers registry, is designed to evaluate real-world outcomes in pulmonary embolism (PE) patients treated with the FlowTriever System (Inari Medical, Irvine, CA). The FlowTriever System is designed to extract large PE thrombus without a need for thrombolytic drugs. Methods: FLASH will enroll up to 500 patients who will be evaluated through 6 months. The primary endpoint is a major adverse events composite of device-related death and major bleeding at 48 hours, and periprocedural device or procedure-related AEs. Secondary endpoints include changes in acute hemodynamics, utility measures, and longer-term clinical outcomes. Acute data in 203 patients and 30-day data in 170 patients has been analyzed. Results and Conclusion: This analyzed cohort included 10% high-risk and 90% intermediate-risk PE patients. The mean RV/LV ratio was 1.54±0.47, sPESI was 1.54±1.06, concomitant DVT was present in 72% and elevated biomarkers in 97% of patients. The primary endpoint occurred in 2 patients (1%) both were major bleeds (non-ICH). There were no periprocedural device related injuries or clinical deteriorations. No deaths (0% mortality) were reported at 48 hours. Significant on-table improvement in hemodynamics were seen, including an average reduction in mean PA pressure of 20% (6.1 mmHg, p&lt;0.0001) and a reduction in heart rate from a pre-procedure high of 111.9±16.9 bpm to 90.5±16.6 bpm (p&lt;0.0001). Patients with low cardiac index (&lt;2l/min/m 2 ) experienced an 18% on table improvement (0.3 l/min/m 2 , p&lt;0.0001). At 30-day follow-up, one patient had died, unrelated to the procedure (0.6% mortality) and 10 patients were readmitted (1 related, 9 unrelated to the procedure). Dyspnea significantly improved from a pre-procedure Modified Medical Research Council Dyspnea Scale average grade of 2.6±1.4 to 0.76±1.1 at 30 days, and 0.54±1 at 6 months (p&lt;0.0001). In conclusion, early results demonstrate excellent safety with immediate improvements in hemodynamics and low 30-day mortality. Data analysis is ongoing and additional results will be presented at the conference.

A single healthcare experience with Impella RP.

To understand the predictors of survival and indications for Impella RP in a single healthcare experience. The Impella RP can be used to temporarily support patients with right ventricular (RV) dysfunction after left ventricular assist device (LVAD) placement or myocardial infarction (MI). However, recent postmarket approval data have raised concerns of higher than expected mortality with this device. A retrospective chart review and analysis of all patients that underwent Impella RP placement in the Emory Healthcare system between January 2016 and December 2018 were performed. Patients were classified according to the indication. A total of 39 patients underwent Impella RP placement. Six patients were post-LVAD, 9 were implanted for massive pulmonary embolism with persistent shock, 8 for postcardiac surgery RV failure (non-LVAD), 11 for RV failure post-MI, and 5 for new or worsening nonischemic cardiomyopathy. The worst survival was noted in MI-related cardiogenic shock group and in patients who presented with cardiac arrest (3/12). All observed deaths were due to persistent refractory shock. There was no device related death. Survival improved during the last year of experience compared to the first 2 years. This study supports the selective use of the Impella RP, with a higher than national reported survival rate (49% vs. 28.6%). Indication appears to be an important factor determining survival.

Infections Associated with Resterilized Pacemakers and Defibrillators

BackgroundAccess to pacemakers and defibrillators is problematic in places with limited resources. Resterilization and reuse of implantable cardiac devices obtained post mortem from patients in wealthier nations have been undertaken, but uncertainty around the risk of infection is a concern.MethodsA multinational program was initiated in 1983 to provide tested and resterilized pacemakers and defibrillators to underserved nations; a prospective registry was established in 2003. Patients who received reused devices in this program were matched in a 1:3 ratio with control patients who received new devices implanted in Canada. The primary outcome was infection or device-related death, with mortality from other causes modeled as a competing risk.ResultsResterilized devices were implanted in 1051 patients (mean [±SD] age, 63.2±18.5 years; 43.6% women) in Mexico (36.0%), the Dominican Republic (28.1%), Guatemala (26.6%), and Honduras (9.3%). Overall, 85% received pacemakers and 15% received defibrillators, with one (55.5%), two (38.8%), or three (5.7%) leads. Baseline characteristics did not differ between these patients and the 3153 matched control patients. At 2 years of follow-up, infections had occurred in 21 patients (2.0%) with reused devices and in 38 (1.2%) with new devices (hazard ratio, 1.66; 95% confidence interval, 0.97 to 2.83; P=0.06); there were no device-related deaths. The most common implicated pathogens were Staphylococcus aureus and S. epidermidis.ConclusionsAmong patients in underserved countries who received a resterilized and reused pacemaker or defibrillator, the incidence of infection or device-related death at 2 years was 2.0%, an incidence that did not differ significantly from that seen among matched control patients with new devices in Canada.

Characterization of device-related malfunction, injury, and death associated with using elastomeric pumps for pain management in the us food and drug administration MAUDE database

Characterization of device-related malfunction, injury, and death associated with using elastomeric pumps for pain management in the us food and drug administration MAUDE database

A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study

ObjectivesThe aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). BackgroundCatheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis. MethodsPatients with symptomatic, computed tomography–documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory–assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy. ResultsFrom April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up. ConclusionsPercutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care.

Worldwide pacemaker and defibrillator reuse: Systematic review and meta-analysis of contemporary trials.

Patients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices. We sought to examine data available from studies regarding contemporary risks of reused devices in comparison with new devices. We searched online indexing sites to identify recent studies. Peer-reviewed manuscripts reporting infection, malfunction, premature battery depletion, and device-related death with reused devices were included. The primary study outcome was the composite risk of infection, malfunction, premature battery depletion, and death. Secondary outcomes were the individual risks. Nine observational studies (published 2009-2017) were identified totaling 2,302 devices (2,017 pacemakers, 285 defibrillators). Five controlled trials were included in meta-analysis (2,114 devices; 1,258 new vs 856 reused). All device reuse protocols employed interrogation to confirm longevity and functionality, disinfectant therapy, and, usually, additional biocidal agents, packaging, and ethylene oxide gas sterilization. Demographic characteristics, indications for pacing, and median follow-up were similar. There were no device-related deaths reported and no statistically significant difference in risk between new versus reused devices for the primary outcome (2.23%vs 3.86% respectively, P=0.807, odds ratio=0.76). There were no significant differences seen in the secondary outcomes for the individual risks of infection, malfunction, and premature battery depletion. Device reuse utilizing modern protocols did not significantly increase risk of infection, malfunction, premature battery depletion, or device-related death in observational studies. These data provide rationale for proceeding with a prospective multicenter noninferiority randomized control trial.

Percutaneous Left Atrial Appendage Closure With LACBES® Occluder - A Preclinical Feasibility Study.

Left atrial appendage closure (LAAC) has been developed as an alternative treatment used for the prevention of strokes in high-risk patients with atrial fibrillation. Here, a novel LAAC prosthesis (LACBES®device) is developed, and its translational potential is investigated by performing a pre-clinical study to evaluate its safety and effectiveness.Methods and Results:LACBES®occluders were implanted in 7 healthy canines percutaneously. Closure effect was evaluated by left atrial angiography. The canines were sacrificed post-procedure on days 45, 80 and 110; gross anatomy was examined subsequently. Endothelialization of device surface was evaluated by HE staining, immunofluorescence staining against CD31 and scanning electron microscope. LACBES®occluders were implanted in all canines successfully; a small residual shunt was observed in 1 canine immediately post procedure. One canine died of groin hematoma within 36 h, which was related to the procedure, but there was no device-related death. A layer of white transparent tissue that failed to cover the nut was formed on the surface of the sealing disc on day 80, but the newborn tissue completely covered the sealing disc on day 110. Immunofluorescence staining against CD31 and scanning electron microscope confirmed complete intima formation and neovascularization within 4 months. The current research suggested the LACBES®device is feasible for LAAC, with a high success rate, few device-related complications and complete neointima formation in canines.

Dynamic Abandon/Extract Decisions for Failed Cardiac Leads

When a cardiac lead fails, physicians implant a new lead and may opt to extract the failed lead and/or any previously abandoned leads. Because the risk of extraction increases in lead age, physicians may extract leads to reduce the future risk of mandatory extraction, due to either infection or limited space in the vein. We develop discrete-time semi-Markov decision process models for various types of cardiac devices to determine patient-specific, lifetime-maximizing extraction policies as a function of patient age and the age of every implanted lead. We use clinical data to calibrate these models and present insightful numerical results, including comparisons to policies commonly used in practice. Our numerical experiments suggest that extracting failed leads only when forced to because of space limitations is usually a good rule of thumb, but that following the optimal policy, as opposed to the commonly used heuristic policies, can extend an average patient’s expected lifetime by up to 1.2 years and decrease the likelihood of device-related death by up to 94% in some cases. The online appendix is available at https://doi.org/10.1287/mnsc.2016.2621 . This paper was accepted by Noah Gans, stochastic models and simulation.

Reuse of pacemakers, defibrillators and cardiac resynchronisation devices

ObjectiveAccess to pacemakers remains poor among many patients in low/middle-income countries. Reuse of explanted pacemakers is a possible solution, but is still not widespread because of concerns regarding outcomes, especially...

Management of Brugada Syndrome 2016: Should All High Risk Patients Receive an ICD? All High-Risk Patients Should Receive an Implantable Cardiac Defibrillator.

Management of Brugada Syndrome 2016: Should All High Risk Patients Receive an ICD? All High-Risk Patients Should Receive an Implantable Cardiac Defibrillator.

Two-year outcome of the Endurant stent graft for endovascular abdominal aortic repair in Japanese patients: incidence of endoleak and aneurysm sac shrinkage.

We aimed to review 50 consecutive Japanese abdominal aortic aneurysm (AAA) and common iliac aneurysm (CIAA) patients to evaluate the 2-year outcomes, particularly endoleak and aneurysm sac shrinkage, of the Endurant stent graft. Between June 2012 and January 2014, 50 consecutive Japanese AAA and CIAA patients underwent EVAR with the Endurant stent graft. Clinical outcomes of overall survival, aneurysm-related survival, and secondary intervention-free survival were analyzed; endoleaks and aneurysm sac changes were also evaluated. The 2-year Kaplan-Meier estimates for overall survival, aneurysm-related survival, and secondary intervention-free survival were 85.4%, 97.7% with one device-related death, and 84.9%, respectively. Type I, II, and III endoleaks at any one point (all comers) after EVAR were detected in 2 (4%), 6 (12%), and 3 (6%) patients, respectively, whereas type IV endoleak was detected in 19 (38%) patients. The percentage of patients with significant sac shrinkage was only 19% (7/37) of the patients at 2 years. Multivariate analysis detected hypertension as a significant factor affecting aneurysm sac shrinkage (OR: 0.09, 95% CI: 0.001-0.99, P=0.049). The Endurant stent graft has demonstrated consistently successful clinical performance in Japanese patients for 2 years. However, the incidence of type IV endoleak was high, while the percentage of significant sac shrinkage was low. Careful and longer follow-up is required to determine the durability of the Endurant stent graft in Japanese patients.

First Clinical Experience with New Left Atrial Appendage Closure Device: WATCHMAN FLX® System

Background: Percutaneous left atrial appendage closure (LAAC) with WATCHMAN (WM) has been recognized as a new interventional routine, but the development of device is continuing. The WATCHMAN FLX® system (WMF) is a new equipment for LAAC which was used in patients since December 2015 until now; however, there is still lack of WMF clinical experience. We therefore evaluate selection of patient, safety, feasibility, and the early results of LAAC with WMF in a single hospital. Results: LAAC was performed using WMF in 16 nonvalvular atrial fibrillation (NVAF) patients mostly with long-term oral anticoagulant contraindication. Mean age at LAAC was 75 ± 5 years, and 70.6% were male. Hypertension, diabetes, and stroke before operation were present in 87.5%, 25%, and 18.8%, respectively. Mean CHADS2, CHA2DS-VASc, and HASBLED scores were 3.0 ± 1.1, 4.0 ± 1.5, and 3.0 ± 1.2, respectively. The success rate of device implantation was 100%, and there were no severe major procedural complications. Transesophageal echocardiography (TEE) was performed in the first 6 weeks and 6 months after LAAC; 100% of patients finished 6 weeks follow-up. No device-related death was recorded. No ischemic stroke/transient ischemic attack was observed. However, three cases experienced device dislocation. WMF devices were out of left appendage, two at descending aorta and one at ascending aorta. Fortunately, all the lost devices were found and successfully captured with Caesar Grasping Forceps System via arteria femoralis (18F sheath). Twelve patients have already accepted 6 months TEE, with one patient detected thrombosis on the WMF surface. Conclusions: LAAC with WM is a safe and effective therapy to prevent stroke in NVAF patients. The WMF is upgrading novel and updated version of the WATCHMAN device, but not the final device. It still needs accumulating clinical experience with WMF, product, and device dislocation should be also be closely monitored.

0355: Complications after transcatheter ASD closure with the amplatzer septal occluder

The aim of this study is to report complications of transcatheter ASD closure using the Amplatzer Septal Occluder (ASO) (St Jude Medical). From December 1999 to October 2013 (April 2014), 760 patients underwent ASD closure with the ASO. Closure was mostly performed under general anaesthesia and transoesophageal echocardiography control. Choice of the device diameter was established after balloon sizing and measurement of the stretched diameter. Mean age of the patients was 31.9±22 years (0.5 month - 84 years). The stretched diameter was 22.5±6.6 mm (5-40mm) and device dimension 22±6.7mm (4-40mm). Duration of the procedure was 41±15 minutes (10-120 minutes) and fluoroscopic time 7.63±6.65 minutes (1-92 minutes). Dose of radiation was 18.7±22 Gy.cm 2 (median 12 Gy.cm 2 ). Implantation succeeded in 96.3% of pts and failure was mainly related to deficient rim. No device related death was noticed. Embolization occurred in 4 pts (0.5%): 1 in the aorta, 1 in the left ventricle, and 2 in the pulmonary artery. All but one underwent surgical extraction and ASD closure. The patient with aortic embolization had percutaneous device extraction and underwent subsequently successful implantation with a larger device. No patient required blood transfusion for any groin hematoma. One patient without aortic rim had hemopericardium one month after implantation; this was corrected by drainage with no recurrence and ASD full occlusion was noticed on colour Doppler control. No late complication was observed. The rate of full occlusion on Doppler control is more than 90%, and the remainings have trivial shunt. Transcatheter ASD occlusion with the Amplatzer Septal Occluder is a safe and effective procedure. The rate of immediate complication is very low and need for immediate surgery following the implantation is rare (<1%). No device related late complications were reported up to 15 years after implantation. The risk of aortic perforation in absence of anterior rim (observed in about 20% of pts) is trivial and not a real limitation in clinical practice.

Early results of the Endurant endograft system in patients with friendly and hostile infrarenal abdominal aortic aneurysm anatomy

To evaluate and compare the outcome after endovascular abdominal aortic aneurysm repair (EVAR) with the newly released Endurant endograft system in patients with different aortoiliac anatomic characteristics. We conducted a prospective observational study assigning patients with infrarenal abdominal aortic aneurysm (AAA) treated with the Endurant endoprosthesis from February 2009 to March 2010. Two groups were studied, according to the presence of a friendly (group I [GI] = 43) or hostile (group II [GII] = 34) infrarenal aortoiliac anatomy. Hostile profile was defined as any (or combination) of the following measurements: 5 mm ≤ proximal neck length (Lpr) ≤ 12 mm, 60° < proximal neck angle (A°pr) ≤ 90° and 60° < any iliac axis angle (A°iliac) ≤ 90°. Primary end points included technical and clinical success, freedom from early or late secondary interventions, any type of endoleak, and aneurysm-related death. All outcome measures were calculated using the Kaplan-Meier method and the log rank test was applied for comparisons between the groups. The mean comorbid severity scoring was higher in GII (P = .018). The mean follow-up period in GI and GII was 12.9 ± 3.9 months (± SD, range: 6.4-19.8) and 12.4 ± 4 months (range: 4.2-19.6), respectively. Two unplanned conversions to aortouniiliac configurations were required in GI. The technical success rate in GI and GII was 95.4% and 100%, respectively. The requirement for intentional occlusion of the internal iliac artery, the requirement for cross-limb technique, the necessity of troubleshooting techniques, the procedure and radiation times, the frequency of postimplantation syndrome, and mean hospital stay were significantly higher in GII (P = .028, P = .013, P = .005, P = .037, P < .001, P = .032, P = .021, respectively). Two patients of GI died in the early postoperative period (one aneurysm but not device-related death), whereas no deaths in GII were recorded, yielding an overall 30-day mortality rate of 2.3%. No type I/III endoleaks were recorded up to the end of the study. Freedom from any type of endoleak, early or late secondary interventions, and aneurysm-related death at 12 months were found in 93.2%, 87.1%, and 93.3% of GI patients; respective values for GII were 86% (P = .21), 93.4% (P = .066), and 93.4%. The clinical success rate was 82.1% and 100% at 12 months for GI and GII, respectively. Early (12 months) results suggest similar clinical performance of the Endurant stent graft system in endovascular treatment of AAAs with friendly and hostile anatomies, however, demonstrating more intra- and perioperative adversities for the last group. Larger prospective studies or even randomized trials comparing different new generation graft models are required to evaluate the comparable long-term results and possible expansion of EVAR indications for this specific endograft in adverse anatomies.

Final Results of the Prospective European Trial of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair

Objectives The Endurant Stent Graft System (Medtronic Vascular, Santa Rosa, CA) is specifically designed to treat patients with abdominal aortic aneurysm, including those with difficult anatomies. This is the 1-year report of a prospective, non-randomised, open-label trial at 10 European centres. Methods Between November 2007 and August 2008, 80 patients were enrolled for elective endovascular aneurysm repair (EVAR) with the Endurant; 71 with moderate (≤60°) and nine with high (60–75°) infrarenal aortic neck angulation. Safety and stent-graft performance were assessed throughout a 1-year follow-up period. Results The device was successfully delivered and deployed in all cases. All-cause mortality was 5% (4/80), with one possibly device-related death. Serious adverse events were comparable between the high and moderate angulation groups. There were no device migrations, stent fractures, aortic ruptures or conversions to open repair. Maximal aneurysm diameter decreased >5 mm in 42.7% of cases. A total of 28 endoleaks were observed (26 type II, two undetermined). Three secondary endovascular procedures were performed for outflow vessel stenosis, graft limb occlusion and iliac extension, resulting in a secondary patency rate of 100%. No re-interventions were required in the high angulation group. Conclusions The Endurant Stent Graft was successfully delivered and deployed in all cases and performed safely and effectively in all patients, including those with unfavourable proximal neck anatomy.

Final Results of the Protected Superficial Femoral Artery Trial Using the Filter Wire EZ System

Conclusion: A distal protection device during femoral popliteal interventions reduces distal migration of debris. Summary: The study evaluated the safety and efficacy of a single distal protection device (Filter Wire EZ Embolic Protection System, Boston Scientific, Mountain View, Calif) for capturing debris during superficial femoral artery (SFA) percutaneous interventions. An additional aim was to define the incidence of distal embolization during SFA interventions. This was a prospective, single-center registry. The study included 30 patients suitable for percutaneous transluminal angioplasty (PTA). Primary end points were occurrence of distal embolization, decreased runoff, improvement in ankle-brachial index (ABI), and number of filters containing emboli. Secondary end points included procedural or device-related death and/or clinical target lesion revascularization, device delivery, deployment success, and incidence of embolic recovery. Procedural success was defined as <30% residual stenosis, with no worsening of distal runoff as determined by angiography. The study enrolled 29 patients with 30 treated limbs, suitable for PTA, between February 2007 and March 2008. Claudication was the indication for intervention in 26 patients and critical limb ischemia in 3. One patient underwent treatment in both legs. The average degree of stenosis was 86% ± 7%, and stenosis length ranged from 8 to 88 mm. No procedural or device-related complications occurred. Average degree of residual stenosis was 10 % ± 10%. ABI improved from 0.56 ± 0.16 to 0.92 ± 0.19 (P < .05). At 1 month, there was no ultrasound-detected waist stenoses or dissections. Microscopic debris was found in 27 of the 30 filters used. Particle size was 1200 ± 640 μm (range, 90-2000 μm). Histologic analysis indicated debris consisted of platelets, erythrocytes, inflammatory cells, extracellular matrix, and cholesterol. There was no correlation between lesion morphology and type of debris. Comment: This is a small, single-center, nonrandomized commercially sponsored study with the first author having a consulting arrangement with the study sponsor. The study is obviously good marketing material for the manufacture of the FilterWire EZ System. However, assuming the author's observations are accurate, the study should bring some measure of concern to all who perform catheter-based SFA interventions, because these interventions seem to be nearly uniformly associated with distal embolization. Long-term clinical implications of these distal emboli remain to be defined, but as someone once said, they may not be bad, but they can't be good! The true clinical utility of embolic protection devices in all vascular beds remains an intriguing, and certainly a potentially profitable, avenue of research.