Kaplan-Meier Estimates Of Freedom Research Articles

SS03. Results of Fenestrated and Branched Endovascular Aortic Aneurysm Repair After Failed Infrarenal Endovascular Aortic Aneurysm Repair

Failure of infrarenal endovascular aortic aneurysm repair (EVAR) owing to loss of proximal seal is increasingly common. Open surgical conversion is challenging and associated with significant morbidity/mortality. The aim of this study was to evaluate the use of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of patients with prior EVAR failure. Consecutive patients enrolled in six, prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/BEVAR between 2012 and 2018, were included in this study. The cohort was stratified according to whether the F/BEVAR procedure was performed after EVAR failure. Demographics, operative details, perioperative complications, and length of stay were compared between groups. Patient survival, type I or type III endoleak, target artery patency, and reintervention rates were calculated using Kaplan-Meier method and compared between groups. A total of 893 patients underwent F/BEVAR; 161 (18%) were treated after failed EVAR and 732 (82%) were treated without prior EVAR. Patients with failed EVAR were more often men (84% vs 66%; P < .01) with larger aneurysms (6.9 cm vs 6.4 cm; P < .01). There were no differences in aneurysm extent (P = .20) between the groups: 19% juxtarenal, 9.2% suprarenal, and 72% thoracoabdominal. The average number of targeted arteries per patient was 3.6 in both groups. The procedural technical success (99% vs 97%; P = .15) did not differ between groups, but radiation dose (4753 mGy vs 2924 mGy; P = .02), dose area product (154,572 mGy cm2 vs 82,842 mGy cm2; P < .01), and operative time (5.2 hours vs 4.6 hours; P < .01), were significantly higher in the failed EVAR group. Median intensive care length of stay (2.9 days) and total length of stay (6.3 days) did not differ between groups. The 30-day mortality rate (failed EVAR, 2.5%; no EVAR, 1.1%; P = .25) and 30-day major adverse event rate (Fig 1) did not differ between groups. Kaplan-Meier estimates of freedom from death (88.3% vs 92.5%; P = .10; Fig 2), type I or type III endoleak (91.9% vs 92.5%; P = .65), target artery occlusion (97.3% vs 97.0%; P = .91), and reintervention at 1 year (84.7% vs 88.7%; P = .10) did not differ between the failed EVAR and no EVAR group, respectively. In this multicenter study, F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes as compared with patients without prior EVAR. However, differences in procedural metrics indicate higher level of technical challenge when performing F/BEVAR in patients with prior failed EVAR.Fig 2Kaplan-Meier estimates of freedom from death. EVAR, Endovascular aortic aneurysm repair.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Results of a Prospective Dose Escalation Study of Linear Accelerator–Based Virtual Brachytherapy (BOOSTER) for Prostate Cancer; Virtual HDR Brachytherapy for Prostate Cancer

PurposeTo demonstrate feasibility and toxicity of linear accelerator–based stereotactic radiation therapy boost (SBRT) for prostate cancer, mimicking a high-dose-rate brachytherapy boost. Methods and MaterialsA phase 1 sequential dose escalation study of SBRT compared 20 Gy, 22 Gy, and 24 Gy to the prostate and 25 Gy, 27.5 Gy, and 30 Gy to the gross tumor volume in 2 fractions, combined with 46 Gy in 23 fractions of external beam radiation. Feasibility of dose escalation (volume receiving 125% and 150% of the dose) while meeting organ-at-risk dose constraints, grade 2 acute and late gastrointestinal and genitourinary toxicity, and freedom from biochemical failure were secondary endpoints. ResultsThirty-six men with intermediate- and high-risk prostate cancer were enrolled with a median follow-up of 24 months. Sixty-four percent of patients had high-risk features. Nine men were enrolled to dose level 1, 6 to level 2, and 6 to level 3. Another 15 patients were treated at dose level 3 on the continuation study. Dose level 3 achieved superior 125% (23.75 Gy) and 150% (28.5 Gy) dose compared to dose levels 1 and 2, with minimal differences in organ-at-risk doses. Kaplan-Meier estimate of freedom from biochemical failure at 3 years was 93.3%. There were no late grade 2 or 3 gastrointestinal events. The late grade 2 genitourinary toxicity at 2 years was 19.3%. Prostate-specific membrane antigen positron emission tomography was performed at 2 years with no local recurrences. ConclusionsWe have shown that a linear accelerator–based SBRT boost for prostate cancer is feasible and can achieve doses comparable to high-dose-rate boost up to the 150% isodose volumes. Rectal, bladder, and urethral doses remained low, and long-term toxicity was the same as or better than previous reports from high-dose-rate or low-dose-rate boost protocols.

Touch-up and recurrence rates after voltage mapping for verification of pulmonary vein isolation following cryoablation of paroxysmal atrial fibrillation

The procedural endpoint following cryoballoon ablation (CA) for paroxysmal atrial fibrillation (PAF) is pulmonary vein isolation (PVI), which is typically confirmed by entrance/exit block using a circular mapping catheter. The present study added an assessment of ablation gaps with high-density voltage mapping after standard confirmation of PVI. Relationships between the need for touch-up ablation, patient characteristics, and atrial arrhythmia recurrence were explored. PAF patients received CA through standard of care treatment, with PVI assessed by bidirectional block confirmation, followed by voltage mapping. Radiofrequency ablation was performed as needed for voltage breakthrough and or additional rhythms. Freedom from atrial arrhythmia recurrence through 12-month follow-up was analyzed retrospectively with statistical survival models. A total of 77 PAF patients (age 66.1 ± 11.6, CHADS2 1.8 ± 1.0) were followed for 1.2 ± 0.3years after CA. During the index procedure, pulmonary vein (PV) touch-up was required in 59 patients (76.6%) and ablation of additional atrial fibrillation targets beyond PV was required in 26 patients (33.8%). Kaplan-Meier estimates of freedom from atrial arrhythmia recurrence at 1year were 62 ± 6%. Rates were lower for patients requiring touch-up ablation (58 ± 6% vs. 78 ± 10%) or with CHADS2 scores > 2 (33 ± 12% vs. 69 ± 6%). Cox regression models showed that the need for touch-up ablation increased recurrence (p = .045, HR = 2.6) after adjusting for hypertension and heart failure. The high rate of PV touch-up suggests that initial CA lesions may be less durable than previously assumed, while the higher recurrence rate in patients requiring touch-up may indicate that additional factors make these patients more difficult to treat.

Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm

ObjectiveEndovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA. MethodsIn this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months. ResultsIn this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months. ConclusionsIn this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.

One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.

Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001). Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

Midterm Single-Center Results of Endovascular Aneurysm Repair With Additional EndoAnchors

Purpose: To review midterm clinical outcomes of EndoAnchor placement during or after endovascular aneurysm repair (EVAR) or chimney EVAR (ch-EVAR). Materials and Methods: A retrospective analysis was conducted of 51 consecutive patients [median age 75 years; 38 men] who underwent EVAR/ch-EVAR with EndoAnchor placement between June 2010 and December 2016 to prevent seal failures (31, 61%) or to treat type Ia endoleak and/or migration (20, 39%). Median aortic neck diameter was 27.7 mm and median neck length was 9.0 mm. Thirty-three (65%) had a conical neck; 48 (94%) had at least 1 hostile neck characteristic. Thirty-two (63%) patients had severe comorbidities (ASA score ⩾III). Eight patients had a single ch-EVAR procedure. Baseline patient characteristics, anatomic variables, procedure details, early and late complications, reinterventions, and aneurysm-related and all-cause mortality rates were recorded. Follow-up imaging was performed with computed tomography angiography (CTA) or duplex ultrasonography. Results: Median procedure time was 100 minutes; a median of 6 EndoAnchors were implanted. There were 10 (10%) residual type Ia endoleaks at the end of the procedure; 9 had resolved by the first postoperative CTA. One residual and 2 new type Ia endoleaks were identified at the first postoperative imaging. Median follow-up for the entire cohort was 24.0 months, during which 3 new type Ia endoleaks were identified. Five of the 6 type Ia endoleaks were treated, 1 resolved spontaneously. There was 1 endograft limb occlusion without clinical consequences, 1 chimney graft occlusion without possibilities for a reintervention, 1 rupture after type IV endoleak (a Nellix device was successfully deployed within the main device), and 1 complete graft explantation for infection. There was no new-onset hemodialysis. Kaplan-Meier estimates of freedom from type Ia endoleak, proximal neck–related reinterventions, and aneurysm-related mortality at 2 years were 87.3%, 92.2%, and 94.0%, respectively. Conclusion: EndoAnchors are helpful in the endovascular treatment of unfavorable proximal aortic necks, with fair midterm results.

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry (ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

Single-Procedure Outcomes and Quality-of-Life Improvement 12MonthsPost-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial.

The CRYO4PERSISTENT AF (Cryoballoon Ablation for Early Persistent Atrial Fibrillation) trial aims to report long-term outcomes after a single pulmonary vein isolation (PVI)-only ablation procedure using the second-generation cryoballoon in persistent atrial fibrillation (PerAF) patients. Pulmonary vein isolation is recognized as the cornerstone of atrial fibrillation (AF) ablation, including ablation of PerAF. The CRYO4PERSISTENT AF trial (NCT02213731) is a prospective, multicenter, single-arm trial designed to assess single-procedure outcomes of PVI using the cryoballoon. The primary endpoint was freedom from AF, atrial flutter, or atrial tachycardia≥30 s after a 90-day blanking period. After enrollment, but before ablation, patients without 100% AF burden (18-h Holter monitoring or 3 consecutive electrocardiograms in a time frame≥14 days) were excluded. Patients were followed at 3, 6, and 12 months, with 48-h Holter monitoring at 6 and 12 months. Quality of life and symptoms were evaluated at baseline and 12 months. Arrhythmia recurrence and adverse events were adjudicated by an independent committee. A total of 101 patients (62 ± 11 years of age, 74% men, left ventricular ejection fraction 56 ± 8%, left atrial diameter 43 ± 5 mm) meeting criteria, undergoing cryoballoon-based PVI, with follow-up data, were included. Kaplan-Meier estimate of freedom from AF, atrial flutter, or atrial tachycardia recurrence was 60.7% at 12 months. Compared with baseline, there were significantly fewer patients with arrhythmia-related symptoms at 12 months (16% vs. 92%; p<0.0001). The symptom reduction was supported by significant improvement in 36-Item Short Form Health Survey composite scores and European Heart Rhythm Association score at 12 months. The only device related event was transient phrenic nerve injury in 2 (2%) patients, with resolution pre-discharge. Cryoballoon ablation for treatment of PerAF demonstrated 61% single-procedure success at 12 months post-ablation in addition to significant reduction in arrhythmia-related symptoms and improved quality of life. (Cryoballoon Ablation for Early Persistent Atrial Fibrillation [Cryo4 Persistent AF]; NCT02213731).

PC128. Serum Resistin Is Associated With Impaired Endothelial Function and Poor Outcomes in Patients With Peripheral Artery Disease

Resistin is a hormone secreted by adipocytes that has been associated with metabolic syndrome and cardiovascular disease. However, less is known on the role of resistin in patients with peripheral artery disease (PAD). The present study seeks to understand the relationship of serum resistin with endothelial function and cardiovascular outcomes in patients with PAD. We hypothesize that increased serum resistin is associated with worse endothelial function and an increased rate of major adverse cardiac events (MACE). One-hundred six patients who presented to clinic with complaints of claudication and an ankle-brachial index of <0.9 or history of revascularization for symptomatic PAD were recruited between 2011 and 2016. Patients were excluded if they had acute illness, renal or hepatic disease, or were taking immunosuppressants. Resistin was assayed using commercially available ELISA kits. Endothelial function was measured via brachial artery flow-mediated vasodilation (FMD) at baseline. Incident MACE were identified by subsequent chart review and defined as a composite end point of myocardial infarction, coronary revascularization, stroke, or death from a cardiac cause. Cox proportional hazards models were used to calculate hazard ratios for MACE. At baseline, despite similar Rutherford scores, medical comorbidities, and medication use, FMD was significantly lower with increasing resistin quartile (I, 9.1 ± 3.3%; II, 7.1 ± 3.5%; III, 5.8 ± 4.0%; IV, 5.6 ± 3.5%; P = .002; Fig 1). A univariate linear regression demonstrated that increasing resistin quartiles predicted lower FMD (II, −1.99 [95% confidence interval (CI), −3.96 to -0.02; P = .05]; III, −3.34 [95% CI, −5.29 to −1.39; P = .001]; IV, −3.52 [95% CI, −5.48 to -1.55; P = .001]). In multivariate linear regression, resistin quartiles III and IV predicted lower FMD relative to the first quartile after adjusting for age, race, body mass index, diabetes mellitus, hypertension, estimated glomerular filtration rate, C-reactive protein, and beta-blocker and angiotensin converting enzyme inhibitor use (III, −2.26 [95% CI, −4.51 to −0.01; P = .05]; IV, -2.53 [95% CI, −4.87 to -0.20; P = .03]). During a median follow-up period of 36 months (interquartile range, 29-45), 21 patients experienced the primary end point. In a Cox proportional hazards model adjusted for smoking status, coronary artery disease, and age, resistin was independently associated with an increased rate of MACE (HR, 1.10; 95% CI, 1.00-1.20; P = .04; Fig 2). Resistin is associated with impaired endothelial function and an increased rate of MACE in patients with PAD. Further research is needed to determine the potential mechanism by which resistin may increase MACE, and prospective studies should determine whether decreasing resistin has therapeutic benefit in patients with PAD.Fig 2: Kaplan-Meier estimate of freedom from major adverse cardiac event (MACE) in the lowest and highest resistin quartiles.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up.

To report the 3-year results of the MAJESTIC first-in-human study of the Eluvia Drug-Eluting Vascular Stent System for treating femoropopliteal artery lesions. The prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal popliteal artery. Mean lesion length was 70.8±28.1mm, and 46% of lesions were occluded. Efficacy measures at 2years included primary patency, defined as duplex ultrasound peak systolic velocity ratio of ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Safety monitoring through 3years included adverse events and TLR. Primary patency was estimated as 83.5% (Kaplan-Meier analysis) at 24months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36months, the Kaplan-Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred. MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent. Level 2b, cohort study.

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial

ObjectivesAtherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. BackgroundSo far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. MethodsIn this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. ResultsSix hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. ConclusionsThe treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174)

Abstract 13416: The Days of the Holter Monitor Are Numbered: Extended Continuous Rhythm Monitoring Detects More Clinically Significant Arrhythmias in Adults With Congenital Heart Disease

Introduction: Arrhythmias are a leading cause of death in adults with congenital heart disease (ACHD). Arrhythmia detection is essential to management and risk assessment in ACHD. While 24 to 48-hour Holter monitors are often used to assess arrhythmia burden, extended continuous rhythm monitors (ECRM) can record 2 weeks of data. We hypothesized that more clinically significant arrhythmias would be detected on ECRM beyond the first 48 hrs of monitoring. Methods: We reviewed ambulatory Zio® (iRhythm, San Francisco, CA) monitors performed in ACHD patients from June 2013 - May 2016. Atrial fibrillation/flutter (AF), ventricular tachycardia (VT), supraventricular tachycardia (SVT), sinus pause &gt;3 sec, and 3 rd or 2 nd degree type II atrioventricular block (AVB) were considered significant. Number and type of arrhythmias detected within the first 48 hrs were compared to those identified beyond 48 hrs. Results: A total of 387 monitors were performed in 306 patients (34 ± 12.5 yrs, 40% male). The most common diagnoses were Tetralogy of Fallot, transposition of the great arteries, and single ventricle after Fontan. Average wear time was 9.4 ± 4.2 d. Overall, 51% of ECRM showed a significant arrhythmia, fewer than half of which were noted during the first 48 hrs (25% overall). VT was detected by ECRM in 17%, only 30% of which were within 48 hrs. SVT was detected by ECRM in 40%, 48% of which were within 48 hrs. Kaplan-Meier estimates of freedom from arrhythmia are shown in the table and figure. Conclusion: ECRM was more likely to detect a significant arrhythmia beyond the standard 48-hour monitoring period in ACHD patients, suggesting that ECRM may be more useful than Holter monitoring in this population.

Endovascular Aneurysm Sealing

Purpose: To report the early and 12-month results of a global registry of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic aneurysms (AAAs). Methods: The EVAS FORWARD Global Registry was a postmarket, multicenter, open-label, single-arm registry that enrolled 277 patients (mean age 75 years; 228 men) treated with the Nellix EVAS system for nonruptured AAAs at 18 sites over a 1-year period. The cohort had challenging aortic anatomy, with 17% having a proximal aortic neck length <10 mm, 8% a neck angulation >60°, and 20% an iliac diameter >25 mm. Baseline and follow-up computed tomography images were assessed by an independent core laboratory, and major adverse events were reviewed by an independent safety committee. Results: Three patients died within 30 days of the procedure (none device-related). There were 13 endoleaks recorded in this time frame: 8 type Ia, 1 type Ib, and 5 type II. Root cause analysis demonstrated that the majority of type Ia endoleaks were due to technical error (low device placement and underfilling of the endobags). Between 30 days and 1 year, there were 4 new type Ia endoleaks; all were treated. There was also 1 type III endoleak between a Nellix device and a distal extension limb. At 1 year, the persistent endoleak rate was 0.7% (1 type Ia and 1 type II). The Kaplan-Meier estimates of freedom from types I and II endoleak at 12-month follow-up were 96% and 98%, respectively. The estimate of freedom from open conversion (n=7) was 98% at 12 months and the rate of freedom from any reintervention was 92%. The need for secondary intervention was associated with aortic morphology; for patients meeting the requirements of the instructions for use (IFU), the freedom from reintervention at 12 months was 98% compared with 86% when the implant was outside the IFU (p=0.009). At 1 year, the estimates of freedom from aortic-related and all-cause mortality were 98% and 95%, respectively. Conclusion: The EVAS FORWARD Global Registry documents the 12-month outcome of EVAS in an unselected group of patients with challenging aortic morphology. The results at present appear acceptable with regard to perioperative outcomes and complications. The type II endoleak rate is low. The place of EVAS in the armamentarium of techniques to treat AAAs will be defined by durability data in the longer term.

Abstract 14943: Significance of Improvement of Advanced Heart Block in Response to Corticosteroid Therapy in Patients With Cardiac Sarcoidosis

Introduction: Advanced heart block (AHB) is one of the major manifestations in patients with cardiac sarcoidosis (CS) and is regarded as a prognostic factor of poor prognosis. Although it has been reported that AHB is improved in response to corticosteroid therapy in some cases, the significance of the improvement remains to be examined. Methods and Result: We examined 68 consecutive patients with CS who admitted to Tohoku University Hospital from October 1998 to September 2014 (57±11 years-old, M/F 18/50, mean follow-up 5.5-year). CS was diagnosed based on the original guidelines for diagnosis of CS from the Japanese Ministry of Health and Welfare. Corticosteroid therapy was performed in all CS patients. Among the 68 patients, 29 (43%) had AHB at admission (AHB group). The AHB group tended to have higher BNP level as compared with those without AHB (no-AHB group) (358±92 vs 200±35 pg/ml, P=0.086), whereas there was no difference in left ventricular ejection fraction between the two groups (50.0±18.9 vs 51.0±14.6%, P=0.801). Kaplan-Meier estimate of freedom from heart failure hospitalization, but not that from all-cause death or VT/VF, showed that the AHB group had more events than the no-AHB group (log-rank P=0.032) (Figure A). Importantly, among the 20 AHB patients after excluding 9 patients with CRT therapy at admission, AHB was improved in 6 in response to corticosteroid therapy but was sustained in the remaining 14, where event-free survival was significantly better in the former than in the latter (log-rank P=0.014) (Figure B). Although BNP levels were comparable between the two groups at admission (242±52 vs. 213±74 pg/ml, P=0.761), there was a significantly greater improvement in the BNP levels in patients with improvement of AHB (125±26 vs 22±7 pg/ml, P=0.022). Conclusions: These results indicate that improvement of AHB in response to corticosteroid therapy may be an important prognostic factor of better prognosis associated with improved cardiac function.

The Significance of Advanced Heart Block in Patients with Cardiac Sarcoidosis

Background: Advanced heart block (AHB) is one of major phenotypes in patients with cardiac sarcoidosis (CS), but their prognosis remains to be elucidated.Methods: We examined 68 consecutive patients with CS in Tohoku university hospital from October 1998 until September 2014 (56611 years-old, M/F 18/50, mean follow-up 5.5-year). CS was diagnosed according to the original guidelines for diagnosis of CS from the Japanese Ministry of Health and Welfare. All of the patients received corticosteroid therapy. Results: Twenty nine out of 68 (43%) patients had AHB at admission (AHB group). The AHB group had a tendency of higher BNP level as compared with no-AHB (358692.4 vs 200635.1pg/ml, p50.086), while there was no difference in left ventricular ejection fraction between groups (50.0618.9 vs 51.0614.6%, p50.801). Kaplan-Meier estimates of freedom from heart failure hospitalization after the introduction of corticosteroid therapy showed that AHB group had more events than no-AHB group did (P50.032). Furthermore, in 20 AHB patients excluding patients with CRT therapy before corticosteroid therapy, 14 AHB patients with non-reversible conduction disturbance had more events compared with 6 patients with reversible one (P50.013). Conclusions: The appearance of AHB could be a sign of poor prognosis in CS patients.

Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study)

Purpose: To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). Methods: In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. Results: Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. Conclusion: Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.

Discharge Glomerular Filtration Rate (GFR) as a Predictor of Outcomes Post Left Ventricular Assist Device Placement

Methods: We identified HM II implants from 9/2009 to 10/2013 at our single center. Patients who required RVAD or ECMO post-operatively or had LVAD exchange were excluded. We created two cohorts: patients with a power spike (defined as pump power O10 watts) during the first 21 post-operative days (n 5 49) vs. patients without a power spike (n 5 150). Over 70,000 pump powers were recorded (median time between measurements of 60 6 83 minutes). Suspected pump thrombosis was defined as direct observation of obstructive thrombus in the pump or conduit following pump exchange or severe hemolysis (defined as lactate dehydrogenase level O1,000 mg/dL in the absence of a kinked inflow or outflow cannula). Results: Over a mean follow-up of 13.2 6 10.8 months, suspected pump thrombosis occurred in 32 of 196 patients. Kaplan-Meier estimates of freedom from pump thrombosis (Figure 1) were significantly higher in patients who did not have power spikes compared with patients who had power spikes (Wilcoxon, P 5 0.026). In Cox proportional hazard models adjusting for age, BMI, INTERMACS profile the HR for hemolysis was 1.91 (95% CI 0.90 4.04, p50.09). The median time between power spike and suspected pump thrombosis was 41 6 231 days, with nine of the eleven events occurring within 103 days of the power spike. Of the 32 patients with suspected pump thrombosis, 20 underwent pump exchange. Fourteen of the 20 had confirmed pump thrombosis. One patient had pannus on his outflow graft, and 5 patients had pumps removed with no thrombus seen in the OR. Conclusion: We conclude that there appears to be an association between HM II LVAD patients with unexplained early power spikes during the first 21 days of HM II support and subsequent suspected pump thrombosis. However, after adjusting for known factors associated with pump thrombosis, this association loses statistical significance. Thus, this association may represent an early event in the natural history of pump thrombosis, an inherent difference in the pump itself, or a marker of patient risk due to intrinsic patient factors.

The Freedom Solo pericardial stentless valve: Single-center experience, outcomes, and long-term durability

ObjectivesTo report our institutional experience and long-term results with the Freedom Solo bovine pericardial stentless bioprosthesis (Sorin Group, Saluggia, Italy). MethodsBetween January 2005 and November 2009, 149 patients (mean age, 73.6 ± 8.7 years; 68 [45.6%] female) underwent isolated (n = 75) or combined (n = 74) aortic valve replacement (AVR) using the Solo in our institution. Follow-up was 100% complete with an average follow-up time of 5.9 ± 2.6 years (maximum, 9.6 years) and a total of 885.3 patient years. ResultsOperative (30-day) mortality was 2.7% (1.3% for isolated AVR [n = 1] and 4.0% for combined procedures [n = 3]). All causes of death were not valve-related. Preoperative peak (mean) gradients of 74.2 ± 23.0 mm Hg (48.6 ± 16.3 mm Hg) decreased to 15.6 ± 5.4 mm Hg (8.8 ± 3.0 mm Hg) after AVR, and remained low for up to 9 years. The postoperative effective orifice area was 1.6 ± 0.57 cm2, 1.90 ± 0.45 cm2, 2.12 ± 0.48 cm2, and 2.20 ± 0.66 cm2 for the valve sizes 21, 23, 25, and 27, respectively, with absence of severe prosthesis-patient mismatch and 0.7% (n = 1) experienced moderate prosthesis-patient mismatch. During follow-up, 26 patients experienced structural valve deterioration (SVD) and 14 patients underwent explantation. Kaplan-Meier estimates for freedom from death, explantation, and SVD at 9 years averaged 0.57 (range, 0.47-0.66), 0.82 (range, 0.69-0.90), and 0.70 (range, 0.57-0.79), respectively. ConclusionsThe Freedom Solo stentless aortic valve is safe to implant and shows excellent early and midterm hemodynamic performance. However, SVD was observed in a substantial number of patients after only 5-6 years and the need for explantation increased markedly, suggesting low durability.

Helical-centreline (BioMimics 3D) stent offers long term patency protection in patients with femoropopliteal disease

Arterial stents are subject to obstruction and failure by intimal hyperplasia (IH). Arterial curvature is physiologically commonly non-planar, or helical, encouraging us to develop a nitinol, self-expanding, bare-metal, helical-centreline stent. On implantation in the common carotid arteries of healthy pigs, this deformed the vessels helically, generating swirling and mixing of intraluminal flow and (compared with findings with a straight-centreline stent) suppressed the development of IH1. Encouraged by these findings, a prospective, randomised, controlled trial was conducted, involving 76 patients, randomised 2:1, undergoing femoropopliteal artery intervention (patients were implanted with the BioMimics 3D (n=50) helical-centreline stent and control subjects were treated with a straight-centreline stent, primarily the Bard LifeStent (24/26 cases). At two years, two key findings were the Kaplan Meier (KM) survival estimate of freedom from loss of primary patency of 72% for BioMimics 3D subjects, versus 55% for the control group (p=0.0497 by log-rank test). Secondly, there was no decrease in the KM estimate of freedom from clinically driven target lesion re-vascularisation (CDTLR) in the BioMimics 3D arm between 12 and 24 months, compared to a decrease of 16% (92% at 12 months and 76% at 24 months) in the control arm. Enhanced wall shear and possibly improved blood-wall mass transport, including of oxygen, may explain the longer-term patency protective effect seen with the BioMimics 3D stent. (1J R Soc Interface, 2013, Vol:10, 1742-5689)

Risk of Pneumonitis After Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer in Patients With Prior Anatomic Resection

Purpose/Objective(s): Stereotactic body radiation therapy (SBRT) has emerged as a standard treatment option for early stage, medically inoperable non-small cell lung cancer (NSCLC). Dosimetric factors including lung volume receiving 20 Gy (V20) >10%and mean lung dose (MLD) >4 Gy are established risk factors for radiation pneumonitis (RP) following SBRT, but limited data evaluate the relative risk of RP in patients undergoing SBRT following prior anatomic lung resection (ALR). This study assessed the incidence of RP and all grade 2+ pulmonary toxicity in patients treated with SBRT for NSCLC following ALR and compare toxicity rates to patients without prior ALR. Materials/Methods: The medical records of 83 consecutive patients with T1-T3 NSCLC treated with 87 courses of SBRT for 93 lung tumors (16 central, 77 peripheral) between January 2007 and September 2013 were reviewed. Sixteen patients with a history of prior ALR were identified, including lobectomy (n Z 12), bilobectomy (nZ 1), and pneumonectomy (n Z 3), with 67 patients without history of prior ALD. The most commonly used fractionation regimen was 50Gy in 5 fractions. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Rates of grade 2+ RP and any grade 2+ pulmonary toxicity were compared between patients with and without prior ALR. Crude rates of RP and all grade 2+ pulmonary toxicity were compared using Fisher’s exact test. Actuarial estimates of freedom from RP (FFRP), in-lobe control (ILC), and overall survival (OS) were calculated with the Kaplan-Meier method and compared between cohorts via the log rank method. Results: At a median follow up of 11.9 months (range 1.2 to 81 months), 3 patients developed grade 2+ RP at a median of 4.0 months (range: 1.0-14.8 months). The crude rates of RP were 6.3% and 2.9% for patients with and without prior ALD, respectively (p>0.05). The 2 year Kaplan-Meier estimates of freedom from RP were 86% and 97% (p>0.05). Crude rates of all grade 2+ pulmonary toxicity were 11.8% and 2.9%, respectively, with associated 2 year estimates of 97% and 81%, respectively (p>0.05). The 2 cohorts were well matched by mean lung dose (4.67 Gy vs 4.15 Gy), lung V20 (5.16% vs 4.35%), mean PTV (30.63 cc vs 36.16 cc), and median prescribed dose (50 Gy vs 54) (p>0.05 for all). Conclusions: Observed rates of pulmonary toxicity were low among patients treated by SBRT after ALR. These data provide reassurances that SBRT can be performed safely for patients with prior ALR when conventional lung DVH constraints are utilized. Author Disclosure: J.T. Hayes: None. A.M. Chen: None. M.E. Daly: None.