Management of Nellix migration and type Ia endoleak from proximal endovascular aneurysm sealing relining to late open conversion.

BACKGROUND: Despite promising early results, midterm failures of the Nellix endovascular aneurysm sealing (EVAS) system (Endologix Inc, Irvine, Calif) have been reported at higher than expected rates. The management of proximal endoleaks and migration differs from those after conventional endovascular aortic aneurysm repair (EVAR) owing to the peculiar design of the Nellix device. In the present study, we report a monocentric experience in the management of EVAS complications using various techniques. We also performed a comprehensive review of the relevant literature on both open surgical and endovascular management of proximal failure of EVAS from the MEDLINE database. METHODS: We retrospectively analyzed the reinterventions for type Ia endoleak and migration after elective infrarenal EVAS at our institution. We collected preoperative, intraoperative, and follow-up data. Open and endovascular techniques are described. Overall survival, aortic-related mortality, and the technical success rate (rate of exclusion of endoleaks) with endovascular techniques were the primary outcomes. RESULTS: We performed 101 infrarenal elective EVAS procedures from 2013 to 2018. Of the 101 patients, 20 (19.8%) had required reintervention for proximal sealing failure. The indications were type Ia (Is2, Is3) endoleak, migration >5 mm, sac expansion >5 mm, and secondary rupture. Of the 20 patients, 6 (30%) were treated with endovascular techniques-2 with a chimney Nellix-in-Nellix application and 4 with proximal relining with a covered stent. The remaining 14 patients (70%) were treated with late open conversion (OC). The average time from EVAS to reintervention was 36.1 months (range, 3-65 months). Six patients (30%) had undergone OC in an emergent setting because of secondary rupture. The technical success rate for the patients treated with endovascular reinterventions was 100%. The 30-day mortality was 20% (4 of 20), all emergent cases (four of six emergent repairs; 67%). The overall survival for the 20 patients was 75% (n = 15) at a mean follow-up of 15.1 months (range, 2-47 months). One patient had died after 7 months of non-aortic-related causes. CONCLUSIONS: The high reintervention rate of the Nellix graft mandates careful evaluation for its further use with the revised instructions for use, and it should not be used off-label. OC remains the strategy of choice when managing Nellix proximal sealing failures in fit patients. Chimney Nellix-in-Nellix application and transcatheter embolization are feasible alternative techniques. Proximal relining also appears to be an effective alternative to more complex interventions, although it requires further studies for validation.

Midterm single-center results after endovascular aneurysm sealing reveal a high rate of stent graft migration, secondary aneurysm ruptures, and device-related reinterventions.

OBJECTIVE: To report procedural results and mid-term follow-up outcomes of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic disease. METHODS: In this retrospective observational study, all patients treated with EVAS between March 2013 and January 2018 for abdominal aortic aneurysm (AAA) or abdominal penetrating aortic ulcer were included. The datasets included demographics, aneurysm morphology, and procedural and clinical surveillance outcomes. Furthermore, patients treated within the original instructions for use (IFU-group) were compared with patients treated outside the IFU (non-IFU-group) with regard to survival, reintervention-free survival, freedom from type I endoleak, and freedom from stent graft migration. RESULTS: Seventy patients were included (67 male; median age, 72.5 years). Sixty-five patients were treated for AAA and 5 patients for abdominal penetrating aortic ulcer. Sixty-nine cases were treated electively (98.6%). Technical success was achieved in 68 cases (97.1%). The median clinical follow-up was 50.5 months (interquartile range, 29.3-62.7 months) with a median computed tomography angiographic follow-up of 38.5 months (interquartile range, 17.1-60.2 months). There were five deaths during the study period (7.1%), four of which were aneurysm related (5.7%). Five secondary AAA ruptures were detected (7.1%). Overall, 25 of 70 patients (35.7%) underwent 35 reinterventions, mostly owing to thrombotic complications (18.6%), stent graft migration (17.1%), and type I endoleak (12.9%). Fifteen patients were treated outside of the IFU (non-IFU-group) (21.4%). The estimated reintervention-free survival for the entire cohort at 30 days and 1, 3, and 5 years was 94.3%, 88.5%, 72%, and 56.9%, respectively. Freedom from stent graft migration at 1, 3, and 5 years was 98.6%, 82.0%, and 47.3%, respectively. The estimated freedom from type I endoleak at 30 days and 1, 3, and 5 years in the IFU-group was 100%, 100%, 94.9% and, 91.1% and significantly different when compared with the non-IFU-group with 79.5%, 72.2%, 72.2%, and 72.2% (P = .012). CONCLUSIONS: Although the technical and initial results were satisfying, the mid-term results were disappointing. The enforcement of a close follow-up protocol for all patients treated with EVAS, especially vigilant for stent graft migration to prevent secondary type I endoleak and rupture, is strongly recommended.

Prediction, pattern recognition and modelling of complications post-endovascular infra renal aneurysm repair by artificial intelligence.

OBJECTIVES: The study evaluates the plausibility and applicability of prediction, pattern recognition and modelling of complications post-endovascular aneurysm repair (EVAR) by artificial intelligence for more accurate surveillance in practice. METHODS: A single-centre prospective data collection on (n = 250) EVAR cases with n = 26 preoperative attributes (factors) on endpoint of endoleak (types I-VI), occlusion, migration and mortality over a 13-year period was conducted. In addition to the traditional statistical analysis, data was subjected to machine learning algorithm through artificial neural network. The predictive accuracy (specificity and -1 sensitivity) on each endpoint is presented with percentage and receiver operative curve. The pattern recognition and model classification were conducted using discriminate analysis, decision tree, logistic regression, naive Bayes and support vector machines, and the best fit model was deployed for pattern recognition and modelling. RESULTS: The accuracy of the training, validation and predictive ability of artificial neural network in detection of endoleak type I was 95, 96 and 94%, type II (94, 83, 90 and 82%) and type III was 96, 94 and 96%, respectively. Endpoints are associated with increase in weights through predictive modeling that were not detected through statistical analytics. The overall accuracy of the model was >86%. CONCLUSION: The study highlights the applicability, accuracy and reliability of artificial intelligence in the detection of adverse outcomes post-EVAR for an accurate surveillance stratification.

Long-term failure after endovascular aneurysm sealing in a real-life, single-center experience with the Nellix endograft.

BACKGROUND: Endovascular aneurysm sealing (EVAS) is an innovative alternative to conventional endovascular aneurysm repair (EVAR). EVAS relies on sac anchoring without proximal fixation to achieve sealing and should have allowed for the treatment of a broader range of anatomic features compared with standard EVAR. Despite the encouraging early reports, the mid- and long-term follow-up data have shown increased rates of failure. To address the issue, the manufacturer introduced revised instructions for use (IFU) in 2016. The present study reports the outcomes of this system after a median follow-up of 45 months. METHODS: Data for all patients electively treated with EVAS at our institution were retrospectively collected. The patients were retrospectively reclassified according to the 2016 revised IFU of the device. All patients in the present series had undergone EVAS for the treatment of infrarenal abdominal aortic aneurysms (AAAs). The primary end point was therapeutic failure: graft migration >5 mm, sac expansion >5 mm, type IA endoleak (Is2 and Is3 using the Van den Ham classification), type Ib endoleak, and secondary rupture. The overall mortality, aortic-related mortality, and reintervention rates were also analyzed. RESULTS: A total of 101 patients had undergone elective treatment by EVAS from 2013 to 2018 for infrarenal AAAs. The median follow-up was 3.75 years. Therapeutic failure was observed in 31 of the 101 patients (30.7%), with no significant difference between the in-IFU and off-IFU 2016 subgroups. Failure occurred at a median interval of 34 months from the index procedure. Of the 101 patients, 6.9% had presented with secondary rupture. Freedom from aneurysm-related mortality was 96.9% at 1 and 2 years and 89.9% at 5 years. Freedom from reintervention decreased over time: 94.7% at 1 year, 77% at 4 years, and 52.1% at 6 years. Of the 101 patients, 14 (13.9%) had undergone emergent or elective graft explantation. CONCLUSIONS: EVAS performed worse than conventional endografts for several critical end points, regardless of any preoperative anatomic parameters. The incidence of therapeutic failures tended to increase over time, especially 4 years after the index procedure.

Iatrogenic embolization following cardiac intervention: postmortem analysis of 110 cases.

INTRODUCTION: Iatrogenic embolization following cardiac investigative procedures may result from hydrophilic polymer emboli (HPE) from catheter valve and vessel wall calcifications, and air embolism from open heart surgery. This retrospective clinical pathologic analysis was undertaken to ascertain the frequency and extent of these potentially fatal complications. METHODS: This retrospective clinical pathologic autopsy analysis with premortem diagnostic imaging correlation identified 110 individuals who had undergone endovascular procedures between 2010 and 2016 within 90 days of death and followed by hospital autopsy. Clinical outcomes, radiologic studies, and autopsy materials were reviewed. RESULTS: Iatrogenic emboli were assessed as causing death in 9/110 autopsy cases (8.2%) and 9/34 (26.5%) cases with proven iatrogenic emboli. Iatrogenic emboli caused strokes in 10/110 (9.1%) autopsy cases including calcified emboli (CE, n=6), HPE (n=2), cardiac valvular tissue (n=1), and air embolism (n=1). Seven cases of calcified emboli complicating endovascular procedures were identified: four of the CE were thought to be the cause of death due to fatal strokes (n=2) and fatal myocardial (n=1) and colonic infarction (n=1). The CE likely originated from calcified aortic valves and atherosclerotic aortic plaques. Histologic evidence of HPE was found in 23% (25/110) of cases; 54% (26/48) showed evidence of infarction in postprocedural imaging, with radiologic evidence of infarction in 32% (8/25) of cases with HPE histology. Endovascular aortic repair was associated with the greatest density/distribution of HPE. HPE material showed degradation with time and was often associated with an inflammatory response. HPE directly contributed to death in three cases. One fatal air embolism followed open heart surgery, and one cardiac tissue embolus resulted in a major stroke. CONCLUSIONS: We advocate for greater awareness of these underrecognized and occasionally fatal complications of endovascular procedures. Targeted postprocedural imaging has a role in the identification of iatrogenic embolic infarcts.

Infrarenal endovascular aneurysm repair with large device (34- to 36-mm) diameters is associated with higher risk of proximal fixation failure.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has become the standard of care for infrarenal aneurysms. Endografts are commercially available in proximal diameters up to 36 mm, allowing proximal seal in necks up to 32 mm. We sought to further investigate clinical outcomes after standard EVAR in patients requiring large main body devices. METHODS: We performed a retrospective review of a prospectively maintained database for all patients undergoing elective EVAR for infrarenal abdominal aortic aneurysms at a single institution from 2000 to 2016. Only endografts with the option of a 34- to 36-mm proximal diameter were included. Requisite patient demographics, anatomic and device-related variables, and relevant clinical outcomes and imaging were reviewed. The primary outcome in this study was proximal fixation failure, which was a composite of type IA endoleak and stent graft migration >10 mm after EVAR. Outcomes were stratified by device diameter for the large-diameter device cohort (34-36 mm) and the normal-diameter device cohort (<34 mm). RESULTS: There were 500 patients treated with EVAR who met the inclusion criteria. A total of 108 (21.6%) patients received large-diameter devices. There was no difference between the large-diameter cohort and the normal-diameter cohort in terms of 30-day (0.9% vs 0.95%; P = .960) or 1-year mortality (9.0% vs 6.2%; P = .920). Proximal fixation failure occurred in 24 of 392 (6.1%) patients in the normal-diameter cohort and 26 of 108 (24%) patients in the large-diameter cohort (P < .001). There were 13 (3.3%) type IA endoleaks in the normal-diameter cohort and 16 (14.8%) in the large-diameter cohort (P < .001). Stent graft migration (>10 mm) occurred in 15 (3.8%) in the normal-diameter cohort and 16 (14.8%) in the large-diameter cohort (P < .001). After multivariate analysis, only the use of Talent (Medtronic, Minneapolis, Minn) endografts (odds ratio [OR], 4.50; 95% confidence interval [CI], 1.18-17.21) and neck diameter ≥29 mm (OR, 2.50; 95% CI, 1.12-5.08) remained significant independent risk factors for development of proximal fixation failure (OR, 3.99; 95% CI, 1.75-9.11). CONCLUSIONS: Standard EVAR in patients with large infrarenal necks ≥29 mm requiring a 34- to 36-mm-diameter endograft is independently associated with an increased rate of proximal fixation failure. This group of patients should be considered for more proximal seal strategies with fenestrated or branched devices vs open repair. Also, this group likely needs more stringent radiographic follow-up.

Device Embolization in Structural Heart Interventions: Incidence, Outcomes, and Retrieval Techniques.

Device embolization is a rare complication of transcatheter structural heart interventions. Although the majority of device embolizations can be treated in a semielective manner, some are life threatening and require prompt intervention. Awareness of this potential complication, and knowledge of retrieval tools and techniques are essential to the structural interventionalist. This paper offers a succinct review of the incidence, and outcomes of device embolization during common structural heart interventions. It also provides an overview of the essential component of the "percutaneous retrieval toolbox" and suggests a systematic algorithmic approach for the management of device embolization.

A Practical Approach to the Management of Complications During Percutaneous Coronary Intervention.

Percutaneous coronary intervention relieves symptoms in patients with chronic ischemic heart disease resistant to optimal medical therapy and alters the natural history of acute coronary syndromes. However, adverse procedural outcomes may occur during the intervention. Knowledge of possible complications and their timely management are essential for the practicing cardiologist and can be life-saving for the patient. In this review, the authors summarize potential complications of percutaneous coronary intervention focusing on their practical management.

Prediction of advanced endovascular stent graft rotation and its associated morbidity and mortality.

OBJECTIVE: Advanced endovascular aneurysm repair (EVAR) with fenestrated and branched stent grafts is increasingly being used to repair complex aortic aneurysms; however, these devices can rotate unpredictably during deployment, leading to device misalignment. The objectives of this study were to quantify the short-term clinical outcomes in patients with intraoperative stent graft rotation and to identify quantitative anatomic markers of the arterial geometry that can predict stent graft rotation preoperatively. METHODS: A prospective study evaluating all patients undergoing advanced EVAR was conducted at two university-affiliated hospitals between November 2015 and December 2016. Stent graft rotation (defined as ≥10 degrees) was measured on intraoperative fluoroscopic video of the deployment sequence. Standard preoperative computed tomography angiography imaging was used to calculate the geometric properties of the arterial anatomy. Any in-hospital and 30-day complications were prospectively documented, and a composite outcome of any end-organ ischemia or death was used as the primary end point. RESULTS: Thirty-nine patients undergoing advanced EVAR were enrolled in the study with a mean age of 75 years (interquartile range [IQR], 71-80 years) and a mean aneurysm diameter of 64 mm (IQR, 59-65 mm). The incidence of stent graft rotation was 37% (n = 14), with a mean rotation of 25 degrees (IQR, 21-28 degrees). A nominal logistic regression model identified iliac artery torsion, volume of iliac artery calcification, and stent graft length as the primary predictive factors. The total net torsion and the total volume of calcific plaque were higher in patients with stent graft rotation, 8.9 ± 0.8 mm-1 vs 4.1 ± 0.5 mm-1 (P < .0001) and 1054 ± 144 mm3 vs 525 ± 83 mm3 (P < .01), respectively. The length of the implanted stent grafts was also higher in patients with intraoperative rotation, 172 ± 9 mm vs 156 ± 8 mm (P < .01). The composite outcome of any end-organ ischemia or death was also substantially higher in patients with stent graft rotation (36% vs 0%; P = .004). In addition, patients with stent graft rotation had significantly higher combined rates of type Ib and type III endoleaks (43% vs 8%; P = .03). CONCLUSIONS: Patients with intraoperative stent graft rotation have a significantly higher rate of severe postoperative complications, and this is strongly associated with higher levels of iliac artery torsion, calcification, and stent graft length. These findings suggest that preoperative quantitative analysis of iliac artery torsion and calcification may improve risk stratification of patients before advanced EVAR.

Endovascular and open surgical treatment of complications after endovascular aortic aneurysm repair: A single-center experience.

While endovascular aortic aneurysm repair (EVAR) has proven to be a safer alternative to open surgical repair for infrarenal abdominal aortic aneurysms (AAA) repair, the development of stent-graft complications mandates follow-up computed tomography imaging to minimize AAA-related mortality. In this single-institution report, adverse EVAR events identified in 150 consecutive patients are detailed. Early morbidity was low (<3%), with only 1 patient death on post-procedure day 2. After discharge (mean follow-up of 24 months), 2 patients died from cancer and one AAA-related mortality occurred after open conversion for stent-graft migration. Although computed tomography imaging detected no EVAR endoleak at 30 days, 19 patients developed an endoleak, including three Type I and four Type III leaks. Our institutional series review confirmed that EVAR of infrarenal AAA is a safe and valid alternative to open surgical repair, but sac embolization at the primary procedure in patients judged to be at high risk for Type II endoleak should be considered.

Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis.

INTRODUCTION: Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA) can develop conductor cable externalization and/or electrical failure. Optimal management of these leads remains unknown. METHODS AND RESULTS: A Markov model compared 4 lead management strategies: (1) routine device interrogation for electrical failure, (2) systematic yearly fluoroscopic screening and routine device interrogation, (3) implantation of new ICD lead with capping of the in situ lead, and (4) implantation of new ICD lead with extraction of the in situ lead. The base case was a 64-year-old primary prevention ICD patient. Modeling demonstrated average life expectancies as follows: capping with new lead implanted at 134.5 months, extraction with new lead implanted at 134.0 months, fluoroscopy with routine interrogation at 133.9 months, and routine interrogation at 133.5 months. One-way sensitivity analyses identified capping as the preferred strategy with only one parameter having a threshold value: when risk of nonarrhythmic death associated with lead abandonment is greater than 0.05% per year, lead extraction is preferred over capping. A second-order Monte Carlo simulation (n = 10,000), as a probabilistic sensitivity analysis, found that lead revision was favored with 100% certainty (extraction 76% and capping 24%). CONCLUSIONS: Overall there were minimal differences in survival with monitoring versus active lead management approaches. There is no evidence to support fluoroscopic screening for externalization of Riata or Riata ST leads.

Reintervention after thoracic endovascular aortic repair of complicated aortic dissection.

OBJECTIVE: This study assessed predictive factors for reintervention after thoracic endovascular aortic repair (TEVAR) for complicated aortic dissection (C-AD). METHODS: An institutional review of consecutive TEVAR for C-AD was performed. RESULTS: Between 2000 and 2011, 41 patients underwent TEVAR for a C-AD involving the descending thoracic aorta. Primary indications included aneurysm >55 mm in 24, rapid aneurysmal enlargement or impending rupture in 6, saccular aneurysm >20 mm in 1, malperfusion in 1, intractable chest pain in 3, and rupture in 6. Technical success was achieved in 100%. The 30-day mortality rate was 5% (n = 2). Fourteen secondary procedures were performed in 13 patients (32%) for indications of device migration in 2, proximal type I endoleak in 5, distal type I endoleak in 2, type II endoleak in 1, aneurysmal evolution of the descending thoracic aorta in 2, aneurysmal expansion of the dissected abdominal aorta in 1, and retrograde dissection in 1. Multivariate analysis demonstrated that oversizing ≥20% (odds ratio [OR], 16; P = .011), bare-spring stent in the proximal landing zone of the stent graft (OR, 12; P = .032), and anticoagulant therapy (OR, 78; P = .03) were significant factors for reintervention. On univariate analysis, large aneurysm was a risk factor for reintervention (P = .002), whereas complete false lumen thrombosis at the stent graft level was protective (P < .05). CONCLUSIONS: This study confirms the feasibility of TEVAR for C-AD, although the rate of reintervention is high. Excessive oversizing, a bare-spring stent graft in the proximal landing zone, large aortic dilatation, and anticoagulant therapy were factors associated with reintervention. Complete false lumen thrombosis at the stent graft level was protective.

SEMS vs cSEMS in duodenal and small bowel obstruction: high risk of migration in the covered stent group.

AIM: To compare clinical success and complications of uncovered self-expanding metal stents (SEMS) vs covered SEMS (cSEMS) in obstruction of the small bowel. METHODS: Technical success, complications and outcome of endoscopic SEMS or cSEMS placement in tumor related obstruction of the duodenum or jejunum were retrospectively assessed. The primary end points were rates of stent migration and overgrowth. Secondary end points were the effect of concomitant biliary drainage on migration rate and overall survival. The data was analyzed according to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. RESULTS: Thirty-two SEMS were implanted in 20 patients. In all patients, endoscopic stent implantation was successful. Stent migration was observed in 9 of 16 cSEMS (56%) in comparison to 0/16 SEMS (0%) implantations (P = 0.002). Stent overgrowth did not significantly differ between the two stent types (SEMS: 3/16, 19%; cSEMS: 2/16, 13%). One cSEMS dislodged and had to be recovered from the jejunum by way of laparotomy. Time until migration between SEMS and cSEMS in patients with and without concomitant biliary stents did not significantly differ (HR = 1.530, 95%CI 0.731-6.306; P = 0.556). The mean follow-up was 57 ± 71 d (range: 1-275 d). CONCLUSION: SEMS and cSEMS placement is safe in small bowel tumor obstruction. However, cSEMS is accompanied with a high rate of migration in comparison to uncovered SEMS.

Peri-procedural morbidity and mortality associated with stent-assisted coiling for intracranial aneurysms.

Despite experience and technological improvements, stent-assisted coiling for intracranial aneurysms still has inherent risks. We evaluated peri-procedural morbidity and mortality associated with stent-assisted coiling for intracranial aneurysms. Patients with cerebral aneurysms that were broad-based (>4 mm) or had unfavorable dome/neck ratios (<1.5) were enrolled in this study between February and November 2011 at our center. Aneurysms were treated with the self-expanding neurovascular stents with adjunctive coil embolization. Seventy-two consecutive patients (27 men and 45 women; 22-78 years of age; mean age, 52.8 years) underwent 13 procedures for 13 ruptured aneurysms and 64 procedures for 73 unruptured aneurysms. Nine [11.7%, 95%CI(4.5%-18.9%)] procedure-related complications occurred: one and eight with initial embolization of ruptured and unruptured aneurysms, respectively. Complications included six acute in-stent thromboses, one spontaneous stent migration, one post-procedural aneurysm rupture, and one perforator occlusion. Three complications had no neurologic consequences. Two caused transient neurologic morbidity, two persistent neurologic morbidity, and two death. Procedure-related neurologic morbidity and mortality rates, respectively, were as follows: overall, 5.2% (95%CI, 0.2%-10.2%) and 2.6% (95%CI, 0%-6.2%); ruptured aneurysms, 7.7% (95%CI, 0%-36%) and 0%(95%CI, 0%-25%); unruptured aneurysms, 4.7% (95%CI, 0%-9.9%) and 3.1% (95%CI, 0%-7.3%). Combined procedure-related morbidity and mortality rates for ruptured and unruptured aneurysms were 7.7% (95%CI, 1.7%-13.7%) and 7.8% (95%CI, 1.8%-13.8%), respectively. Stent-assisted coiling is an attractive option for intracranial aneurysms. However, stent-assisted coiling for unruptured aneurysms is controversial for its comparable risk to natural history.

Endovascular repair of ruptured infrarenal abdominal aortic aneurysm is associated with lower 30-day mortality and better 5-year survival rates than open surgical repair.

OBJECTIVE: Endovascular aneurysm repair (EVAR) decreases 30-day mortality for patients with ruptured abdominal aortic aneurysms (r-AAAs) compared with open surgical repair (OSR). However, which patients benefit or whether there is any long-term survival advantage is uncertain. METHODS: From 2002 to 2011, 283 patients with r-AAA underwent EVAR (n = 120 [42.4%]) or OSR (n = 163 [57.6%]) at Albany Medical Center. All data were collected prospectively. Patients were analyzed on an intention-to-treat basis, and outcomes were evaluated by a logistic regression multivariable model. Kaplan-Meier analysis was used to compare long-term survival. RESULTS: The EVAR patients had a significantly lower 30-day mortality than did the OSR patients (29/120 [24.2%] vs 72/163 [44.2%]; P < .005) and better cumulative 5-year survival (37% vs 26%; P < .005). Men benefited more from EVAR (mortality: 20.9% for EVAR vs 44.3% for OSR; P < .001) than did women (mortality: 32.4% vs 43.9%; P = .39). Age ≥80 years was a significant predictor of death for EVAR (odds ratio [OR], 1.07; P = .003) but not for OSR (OR, 1.04; P = .056). Preexisting hypertension was a significant predictor of survival for both EVAR (OR, 0.17; P < .001) and OSR (OR, 0.48; P = .021). Almost one fourth of EVAR patients (21/91 [23.1%]) required secondary interventions. Survival advantage was maintained for EVAR patients to 5 years. CONCLUSIONS: For r-AAA, EVAR reduces the 30-day mortality and improves long-term survival up to 5 years. However, whereas open survivors require few graft-related interventions, up to 23% of EVAR patients will require reintervention for endoleaks or graft migration. Close follow-up of all EVAR survivors is mandatory.

Lead complications, device infections, and clinical outcomes in the first year after implantation of cardiac resynchronization therapy-defibrillator and cardiac resynchronization therapy-pacemaker.

AIMS: The decision to implant a cardiac resynchronization therapy (CRT) system with (defibrillator, CRT-D) or without (pacemaker, CRT-P) cardioverter defibrillator should weigh its benefits and risks. This study examined the (i) incidence of loss of capture and infectious complications and (ii) 1-year clinical outcomes of 402 CRT-D and CRT-P recipients enrolled in the MASCOT study. METHODS AND RESULTS: The indications for CRT-D or CRT-P were posed by the implanting physicians. All (i) losses of atrial and right and left ventricular capture, (ii) system-related infections, and (iii) clinical outcomes, including hospitalizations for worsening heart failure (HF) and deaths from all causes, were recorded up to 1 year of follow-up. Cardiac resynchronization therapy-defibrillator was implanted in 228 (57%) and CRT-P in 174 (43%) patients. The incidence of loss of capture was greater in CRT-D with 21 patients (9.2%) than in CRT-P with 6 patient (3.5%) recipients (P = 0.01), while the infection rates were 1.3% (3 patients) and 1.2% (2 patients), respectively (ns). In the CRT-D group, 42 of 228 patients (18.4%) died or were hospitalized for HF, compared with 38 of 174 patients (21.8%) in the CRT-P group (ns). In the CRT-D group, 23 patients (10.1%) were hospitalized for worsening HF and 20 (8.8%) patients died, vs. 22 (12.6%) and 19 (10.9%) patients, respectively, in the CRT-P group (ns for both comparisons). CONCLUSIONS: Cardiac resynchronization therapy-defibrillator was implanted in 57% of candidates for CRT. Within 1 year after device implant, the incidence of loss of capture at any lead was nearly three-fold greater among CRT-D than among CRT-P recipients. System-related infections were infrequent and clinical outcomes were similar in both groups.

The influence of smoking on endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The main purpose of this study was to evaluate the influence of smoking on perioperative outcomes of endovascular aneurysm repair (EVAR), aneurysm sac behavior, abdominal aortic aneurysm (AAA) neck growth after EVAR, and its effect on stent graft migration during follow-up. METHODS: Baseline characteristics and follow-up data were collected prospectively by patient record forms. Follow-up visits were scheduled at 1, 3, 6, 12, 18, and 24 months, and annually thereafter and included a clinical examination and imaging studies. Patients were stratified in three groups according to their smoking status as nonsmokers, former smokers, and smokers. RESULTS: This study analyzed the data for 4176 nonsmokers, 2406 former smokers, and 2056 smokers who were enrolled prospectively in the European Collaborators on Stent-Graft Techniques for Aortic Aneurysm Repair (EUROSTAR) database. Compared with nonsmokers, smokers required more percutaneous transluminal angioplasty and stent placements during EVAR (P < .001), and stent graft migration occurred more often (hazard ratio, 1.45; 95% confidence interval, 1.03-2.05; P = .033). Nonsmokers had more late type II endoleaks than former smokers and smokers (58.5%, 55.9%, and 35.5%, respectively; P < .001). Smoking had no effect on aneurysm sac behavior or AAA neck growth after EVAR. CONCLUSIONS: Smokers need more percutaneous transluminal angioplasty procedures and stents during EVAR. They have fewer late type II endoleaks during follow-up; however, smokers should be closely monitored because they have an increased risk of stent graft migration.

Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications.

PURPOSE: To report the occurrence of fracture of the Recovery filter and incidence of potentially life-threatening complications associated with fractured fragment migration. MATERIALS AND METHODS: A retrospective study of images obtained after placement of Recovery inferior vena cava (IVC) filters from 2003 to 2006 was conducted at a single tertiary-care center. Images were reevaluated for fracture and migration; complications related to filter fracture were investigated. Kaplan-Meier survival analysis was performed to investigate the relationship between time in situ and fracture. RESULTS: A total of 363 Recovery filters were placed; 97 were retrieved, leaving 266 filters in situ (135 patients subsequently died of other causes). The following images were evaluated: 130 chest computed tomography (CT) scans, 153 abdominal CT scans, 254 chest radiographs, 148 radiographs of the abdomen/pelvis, and 106 cavagrams. Mean imaging follow-up interval was 18.4 months (maximum, 81.3 mo). No en bloc migration occurred outside the IVC. Twenty-six limb fractures (all short limbs) were identified in 20 patients; the earliest occurred at 4.1 months. Eight fragment migrations occurred into pulmonary arteries, seven into iliac/femoral veins, one into the right ventricle, and one into the renal vein. Seven fragments were intracaval near the filter, one was extracaval, and one could not be located. Kaplan-Meier survival estimates predicted a fracture rate of 40% at 5.5 years. Of the 20 patients with filter fractures, three died of unrelated causes and 17 remain asymptomatic. CONCLUSIONS: Recovery filter fractures occurred at the short limb only, with a suggested 5.5-year fracture risk of 40%. No life-threatening events occurred in patients with filter fracture.

Midterm outcomes of the Zenith Renu AAA Ancillary Graft.

OBJECTIVE: The Zenith Renu abdominal aortic aneurysm (AAA) Ancillary Graft (Cook Medical Inc, Bloomington, Ind) provides active proximal fixation for treatment of pre-existing endografts with failed or failing proximal fixation or seal. The purpose of this study was to evaluate the midterm outcomes of treatment with this device. METHODS: From September 2005 to November 2006, a prospective, nonrandomized, multicenter, postmarket registry was utilized to collect physician experiences from 151 cases (89 converters and 62 main body extensions) at 95 institutions. Preoperative indications and procedural and postimplantation outcomes were collected and analyzed. Technical success and clinical success were determined as defined by the Society of Vascular Surgery reporting standards. RESULTS: Patients were predominantly male (87%) with a mean age of 77 years. The interval between the original endograft implantation to Renu treatment was 43.4 ± 18.7 months. The indications for treatment were endoleak (n = 111), migration (n = 136), or both (n = 94). Technical success was 98.0% with two cases of intraoperative conversion and one case of persistent type IA endoleak. The median follow-up for the cohort was 45.0 months (range, 0-56 months; interquartile range, 25.0 months). Overall, 32 cases had treatment failures that included at least one of the following: death (n = 5), type I/III endoleak (n = 18), graft infection (n = 1), thrombosis (n = 1), aneurysm enlargement >5 mm (n = 9), rupture (n = 4), conversion (n = 9, with 7 after 30 days), and migration (n = 1). Overall, the clinical success for the entire cohort during the follow-up period was 78.8% (119/151). CONCLUSIONS: The postmarket registry data confirm that the Zenith Renu AAA Ancillary Graft can be used to treat endovascular repairs that failed due to proximal attachment failures. The salvage treatment with the Renu device had high technical success rate and resulted in clinical success in a majority of patients (78.8%). While failed endovascular repairs can be salvaged, a clinical failure in one of five patients still emphasizes the importance of patient and device selection during initial endovascular aneurysm repair to ensure durable success.