Procedure-related Serious Adverse Events Research Articles

Real-World Patent Foramen Ovale (PFO) Closure in Japan - 30-Day Clinical Outcomes From the AmplatzerTM PFO Occluder Japan Post-Marketing Surveillance Study.

The AmplatzerTM PFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-marketing Surveillance (PFO Japan PMS) study was initiated in December 2019. This analysis presents 30-day clinical outcomes for PFO Japan PMS study patients.Methods and Results: PFO Japan PMS is a prospective single-arm non-randomized multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the AmplatzerTM PFO Occluder. Technical success was defined as successful delivery and release of the occluder; procedural success was defined as technical success with no serious adverse events (SAEs) within 1 day of the procedure. The primary safety endpoint includes predefined device- and/or procedure-related SAEs through 30 days after the procedure. From December 2019 to July 2021, 500 patients were enrolled across 53 Japanese sites. The mean (±SD) patient age was 52.7±15.4 years, and 29.8% of patients were aged >60 years. Technical and procedural success rates were both high (99.8% and 98.8%, respectively). Further, there was only one primary safety endpoint event (0.2%): an episode of asymptomatic paroxysmal atrial fibrillation that occurred 26 days after the procedure. In this real-world Japanese study with almost one-third of patients aged >60 years, PFO closure with the AmplatzerTM PFO Occluder was performed successfully and safely, with a low incidence of procedure-related atrial arrhythmias.

Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study.

Introduction: The safety and effectiveness of the GORE VIABAHN Endoprosthesis for treatment of symptomatic patients with peripheral artery disease (PAD) and complex femoropopliteal (FP) lesions was assessed in a real-world Japanese practice setting. Methods: A prospective, multicenter, postmarket surveillance study was conducted from 2016 to 2017 at 64 sites in Japan. Symptomatic patients with PAD and FP lesions ⩾ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment. Outcome measures evaluated at 5 years were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results: A total of 321 patients were enrolled and were a mean age of 73.9 ± 8.7 years; 77.3% were men and 26.5% had chronic limb-threatening ischemia (CLTI). The mean lesion length was 23.6 ± 6.6 cm and the frequency with TASC II C/D lesions and chronic total occlusions was 86.6% and 70.4%, respectively. The Kaplan-Meier estimated PP, PAP, SP, and fTLR at 5 years was 62.4%, 74.1%, 82.3%, and 75.9%, respectively. The mean ankle-brachial index was 0.92 ± 0.15 and the mean improvement in Rutherford class was 2.3 ± 1.4, which was maintained through 5 years. The rate of cumulative device- or procedure-related SAEs through 5 years was 19.9% with only 9.3% of those occurring after the first year. No stent fractures were observed through 5 years by x-ray evaluation. Conclusion: The 5-year safety and efficacy outcomes of the endoprosthesis were clinically acceptable for treating complex FP lesions in a real-world cohort of Japanese patients with PAD. (ClinicalTrials.gov Identifier: NCT04706273).

Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes.

To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized USFood and Drug Administration (FDA) 522 cohort study. Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups. Three hundred fifty-fivewomen underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty(76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95%CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine(81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months. Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.

Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry

BackgroundCryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized.MethodsPatients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up.ResultsA total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection.ConclusionsDespite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02752737Graphical

Fecal Microbiota Transplant in Pediatric Solid Organ Transplant Recipients.

Fecal microbiota transplant (FMT) is an effective treatment for recurrent Clostridioides difficile infection (CDI). Safety concerns around FMT are increased in immunocompromised populations, such as solid organ transplant (SOT) recipients. Outcomes among adult SOT recipients suggest FMT is efficacious and safe; however, pediatric SOT data are lacking. We describe the efficacy and safety of FMT among pediatric SOT recipients in a single-center retrospective study from March 2016 to December 2019. Successful FMT was defined as no recurrence of CDI within 2 mo of FMT. We identified 6 SOT recipients ages 4-18 y who received FMT a median of 5.3 y post-SOT. Success after a single FMT was 83.3%. One liver recipient did not achieve cure after 3 FMTs and remains on low-dose vancomycin. One serious adverse event (SAE) occurred; cecal perforation and bacterial peritonitis occurred following colonoscopic FMT coordinated with intestinal biopsy in a kidney transplant recipient. He achieved full recovery and CDI cure. There were no other SAEs. There were no adverse events related to immunosuppression or transplantation status including: bacteremia, cytomegalovirus activation or reactivation, allograft rejection, or allograft loss. In this limited series, efficacy of FMT in pediatric SOT is comparable to efficacy in the general pediatric recurrent CDI population. There may be an increased risk of procedure-related SAE in SOT patients and larger cohort studies are needed.

LBA01-05 PIVOTAL STUDY OF A NOVEL WIRELESSLY POWERED, PATIENT TAILORED PROGRAMMED, TIBIAL NEUROSTIMULATOR FOR THE TREATMENT OF PATIENTS WITH OVERACTIVE BLADDER

You have accessJournal of UrologyCME1 Apr 2023LBA01-05 PIVOTAL STUDY OF A NOVEL WIRELESSLY POWERED, PATIENT TAILORED PROGRAMMED, TIBIAL NEUROSTIMULATOR FOR THE TREATMENT OF PATIENTS WITH OVERACTIVE BLADDER John Heesakkers, Alessandro Digesu, Suzette Sutherland, Osvaldo Padron, Cindy Amundsen, Rebecca McCrery, Emily Kean, Kevin Benson, Kevin Cline, Kaiser Robertson, Felicia Lane, Frank Martens, Stefan De Wachter, Kimberley Ferrante, Laura Giusto, Roger Dmochowski, and Philip Toozs-Hobson John HeesakkersJohn Heesakkers More articles by this author , Alessandro DigesuAlessandro Digesu More articles by this author , Suzette SutherlandSuzette Sutherland More articles by this author , Osvaldo PadronOsvaldo Padron More articles by this author , Cindy AmundsenCindy Amundsen More articles by this author , Rebecca McCreryRebecca McCrery More articles by this author , Emily KeanEmily Kean More articles by this author , Kevin BensonKevin Benson More articles by this author , Kevin ClineKevin Cline More articles by this author , Kaiser RobertsonKaiser Robertson More articles by this author , Felicia LaneFelicia Lane More articles by this author , Frank MartensFrank Martens More articles by this author , Stefan De WachterStefan De Wachter More articles by this author , Kimberley FerranteKimberley Ferrante More articles by this author , Laura GiustoLaura Giusto More articles by this author , Roger DmochowskiRoger Dmochowski More articles by this author , and Philip Toozs-HobsonPhilip Toozs-Hobson More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003360.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The BlueWind Medical Device is a novel miniature, leadless, battery-less, sub-facially implantable tibial neuromodulation system. The implant is wirelessly powered and modulated by an external wearable unit. A Clinician Programmer is used to individually tailor stimulation parameters (i.e., frequency, pulse width and amplitude). A pivotal trial was conducted to evaluate the safety and efficacy of the BlueWind Medical Device for treating Urge Urinary Incontinence (UUI) in women. METHODS: One hundred and fifty-one women with UUI were enrolled in 23 centers in the United States and Europe, for this prospective, single arm, open-label study. Inclusion criteria required at least 9 UUI episodes during a 7-day diary. The device was activated ∼4 weeks after implantation, and the patients performed daily stimulation treatments at home for ∼30 minutes twice daily. Stimulation parameters were individually tailored according to a predefined algorithm per patient sensation and response. Multiple Treatment Programs were provided for patients when needed. Voiding diaries, quality of life and patient satisfaction questionnaires were collected at 6 and 12 months after device activation. The primary safety measure was incidence of Adverse Events (AE) at 12 months post activation. Primary efficacy end point was defined as ≥50% reduction in UUI episodes compared to baseline. RESULTS: One hundred and fifty-one subjects, mean age 58.8 (SD: 12.5) were implanted. The subjects demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Results are presented based on the intend to treat analysis set with 144 and 140 patients reaching 6- and 12-months post activation, respectively. No device or procedure related Serious Adverse Events (SAE) were reported by 12 months. At 6 and 12 months, 76.4% and 78.4% of the subjects were therapy responders (p<.0001), respectively, with 50% of the subjects dry at 12 months (on 3 consecutive days diary). At 12 months, 84.6% of the patients showed ≥10 points improvement (Minimal Important Difference; MID) in Health Related Quality of Life (p<.0001). CONCLUSIONS: The BlueWind Medical Device has demonstrated an excellent safety profile with no device or procedure related SAEs. Efficacy endpoints were met with high proportion of dry patients, high compliance, and high patient satisfaction. Source of Funding: BlueWind Medical is the Sponsor of OASIS trial © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1178 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Heesakkers More articles by this author Alessandro Digesu More articles by this author Suzette Sutherland More articles by this author Osvaldo Padron More articles by this author Cindy Amundsen More articles by this author Rebecca McCrery More articles by this author Emily Kean More articles by this author Kevin Benson More articles by this author Kevin Cline More articles by this author Kaiser Robertson More articles by this author Felicia Lane More articles by this author Frank Martens More articles by this author Stefan De Wachter More articles by this author Kimberley Ferrante More articles by this author Laura Giusto More articles by this author Roger Dmochowski More articles by this author Philip Toozs-Hobson More articles by this author Expand All Advertisement PDF downloadLoading ...

Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry.

The purpose of this study was to report the safety and performance of aspiration thrombectomy with the Penumbra System for patients with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO) and late onset to treatment. This is a retrospective subset analysis of a global prospective multicenter registry (COMPLETE) that enrolled adults with AIS due to LVO and a pre-stroke modified Rankin Scale score (mRS) of 0 or 1 who were treated first-line with aspiration thrombectomy either alone (A Direct Aspiration First Pass Technique [ADAPT]) or in combination with the 3D Revascularization Device (ADAPT + 3D). This subset analysis included all patients in the registry who had anterior circulation LVO, an Alberta Stroke Program Early CT Score of at least 6, and late onset to treatment (>6 h from stroke onset to puncture). Of the 650 patients in the COMPLETE registry, 167 were included in this subset analysis. The rate of successful revascularization (modified thrombolysis in cerebral infarction score 2b-3 achieved) at the end of the procedure was 83.2%, the rate of good functional outcome (mRS 0-2) at 90 days was 55.4%, and the all-cause mortality rate at 90 days was 14.4%. No device-related serious adverse events (SAEs) occurred. Procedure-related SAEs occurred in 9 patients (5.4%) within 24 h and in 12 patients (7.2%) overall. The rate of successful revascularization was higher for patients treated first-line with ADAPT (88.0%) than for patients treated first-line with ADAPT + 3D (75.0%; p = 0.035); no significant difference was observed between the ADAPT and ADAPT + 3D groups for any other primary or secondary outcome. For patients with AIS due to anterior circulation LVO and with late onset to treatment, aspiration thrombectomy with the Penumbra System appears to be safe and effective. The rates of good functional outcome and all-cause mortality from this study compared favorably with those rates from the medical management arms of the DAWN and DEFUSE-3 studies. https://www.clinicaltrials.gov, NCT03464565.

Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation

Abstract Background Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized. Purpose To evaluate regional variations in patient selection and procedural characteristics for PVI with cryoablation in the Cryo Global Registry (NCT02752737). Methods Patients with AF were enrolled from May 2016 to October 2021 at 128 sites in 37 countries. Patients were treated with cryoballoon ablation according to local clinical practice. Baseline subject and procedural characteristics were summarized for 8 regions (Central Asia and Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Procedure-related serious adverse events (SAEs) were evaluated in a subset of patients with ≥7 days of follow-up. Results A total of 3680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was more commonly performed in patients with paroxysmal vs. persistent AF in all regions, and in males vs. females in all regions except Central Asia and Russia. Mean age ranged from 47±12 in the Middle East to 64±11 in East Asia. Regional variations were observed in the proportion of patients with common AF comorbidities undergoing cryoablation (Table 1). Median procedure time ranged from 61 (49–68) minutes in Central Asia and Russia to 95 (76–120) minutes in Southeast Asia. Median fluoroscopy time was ≤20 minutes in all regions. The use of 3D mapping was relatively uncommon except in North America (63.3%). Large variation was observed in the use of esophageal monitoring, whereas phrenic nerve monitoring was used in ≥97.7% of cases in all regions (Table 2). Same-day discharge was uncommon except in North and South America (37.8% and 26.5% of cases, respectively). Average freeze duration ranged from 153±41 seconds in Southeast Asia to 230±29 seconds in Central Asia and Russia. Mean number of applications per vein ranged from 1.2±0.4 in Central Asia and Russia to 2.1±1.0 in North America. Acute procedural success was ≥94.7% in all geographies and focal radiofrequency touch-up was required in ≤13.0% of cases. In 3126 subjects with ≥7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%), and 1 procedure-related death was reported during data collection. Conclusion(s) Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation is performed with high acute success and short procedural times around the world. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic, Inc.

Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study

BackgroundCatheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA). ObjectivesThe aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE). MethodsPatients with symptoms of acute PE with computed tomographic evidence of RV dilatation were enrolled. The Bashir catheter was used to deliver 7 mg tPA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory–assessed change in computed tomographic angiography–derived RV/left ventricular (LV) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events (SAEs) including major bleeding at 72 hours. ResultsAt 18 U.S. sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT, the RV/LV diameter ratio decreased by 0.56 (33.3%; P < 0.0001). PA obstruction as measured by the refined modified Miller index was reduced by 35.9% (P < 0.0001). One patient (0.92%) had 2 SAEs: a retroperitoneal bleed (procedure related) and iliac vein thrombosis (device related). Two other procedure-related SAEs were epistaxis and non–access site hematoma with anemia. ConclusionsPM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and a very low rate of adverse events or major bleeding in patients with intermediate-risk acute PE. The notable finding was a significant reduction in PA obstruction with low-dose tPA. (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden [RESCUE]; NCT04248868)

Abstract WP159: Effect Of Multiple Passes During Mechanical Thrombectomy On Clinical Outcomes

Introduction: Reperfusion with mechanical thrombectomy improves outcomes in patients with Large Vessel Occlusion Acute Ischemic Stroke (LVO-AIS). The technical goal of thrombectomy is reperfusion to a modified Thrombolysis in Cerebral Infarction (mTICI) grade ≥ 2b. Here we investigate if procedures requiring multiple passes to achieve complete reperfusion (MP mTICI 3) result in better outcomes compared to procedures stopped after achieving mTICI 2b-2c on the first pass (FP mTICI 2b-2c). Methods: Using data from the COMPLETE registry (a global prospective study of LVO-AIS patients who underwent mechanical thrombectomy using the Penumbra System), we grouped patients into MP mTICI 3 and FP mTICI 2b-2c. Functional independence (mRS 0-2) at 90 days, all-cause mortality at 90 days, device-related serious adverse events (SAE) ≤ 24 hours, procedure-related SAEs ≤ 24 hours, embolization to new or previously uninvolved territories (ENT), symptomatic intracranial hemorrhage (sICH) ≤ 24 hours, vessel perforation, vessel dissection, and length of stay were compared. Results: Of the 650 patients in the COMPLETE registry, 215 were included in this subgroup analysis; 111 were categorized as MP mTICI 3, and 104 as FP mTICI 2b-2c. The MP mTICI 3 group has fewer M1 occlusions (48% vs 67%, p = 0.004) and more ICA-T occlusions (19% vs. 9%, p = 0.032). The groups were otherwise well matched with respect to age, sex, medical history, pre-procedure ASPECTS, NIHSS, IV tPA use, onset-to-puncture time, and occlusion etiology. Outcomes are shown in table 1. Conclusions: In this exploratory subgroup analysis, we found that procedures requiring multiple passes to achieve complete revascularization were not associated with improved outcomes compared to procedures stopping after achieving mTICI 2b-2c on the first pass.

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries

Purpose: To assess the midterm safety and effectiveness of the Gore® Viabahn® Endoprosthesis as treatment for symptomatic peripheral arterial disease (PAD) in the superficial femoral arteries (SFA). Materials and Methods: A prospective, multicenter, post-market surveillance study was conducted in Japan. Patients with symptomatic SFA lesions ≥ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment; patients with traumatic or iatrogenic vessel injury in the thoracic, abdominal, or pelvic arteries were excluded. Outcomes evaluated at 12 months were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results: From August 2016 to May 2017, 321 patients were enrolled at 64 Japanese sites (mean age, 73.9±8.7 years; 77.3% male). Hypertension, diabetes, and end stage renal disease were present in 84.4%, 54.8%, and 23.1% of patients, respectively. Mean lesion length was 23.6 cm±6.6 cm, with lesions ≥ 15 cm in 271 patients (84.4%). TASC C/D lesions accounted for 86.6% (39.1% TASC C, 47.5% TASC D); 26.5% had critical limb ischemia. Baseline ABI was 0.60±0.16. A total of 562 devices were implanted in 324 limbs, with a majority of patients (68.8%) receiving 2 stents. Through 12 months, 92.1% of patients were evaluable. Kaplan-Meier-estimated PP, PAP, and SP at 12 months was 85.6%, 91.7%, and 94.8%, respectively. Twelve-month fTLR was 92.3%. Mean change in ABI at 12 months was 0.343±0.21; mean improvement in Rutherford class was 2.5. Device- or procedure-related SAEs occurred in 3.1% through 30 days, with a majority of early SAEs consisting of access complications. Through 12 months, a cumulative 10.6% had device- or procedure-related SAEs, with the most common being device occlusions in 4.0%. Lower limb amputation occurred in 0.9% and was related to pre-existing ulceration or gangrene in all 3 cases. No stent fractures were observed at 12-month x-ray evaluation. Conclusion: In a real-world Japanese patient population characterized by long SFA lesions and complex PAD, the Viabahn endoprosthesis was associated with excellent patency rates through 12 months and an acceptable safety profile.

Applicability of colon capsule endoscopy as pan-endoscopy: From bowel preparation, transit, and rating times to completion rate and patient acceptance.

Background and study aims Colon capsule endoscopy (CCE) has the potential to explore the entire gastrointestinal tract. The aim of this study was to assess the applicability of CCE as pan-endoscopy. Patients and methods Healthy participants received CCE with bowel preparation (bisacodyl, polyethylene electrolyte glycol (PEG) + ascorbic acid) and booster regimen (metoclopramide, oral sulfate solution (OSS)). For each segment of the gastrointestinal tract, the following quality parameters were assessed: cleanliness, transit times, reading times, patient acceptance and safety of the procedure. When all gastrointestinal segments had cleansing score good or excellent, cleanliness of the whole gastrointestinal tract was assessed as good. Participants’ expected and perceived burden was assessed by questionnaires and participants were asked to grade the procedure (scale 0–10). All serious adverse events (SAEs) were documented. Results A total of 451 CCE procedures were analyzed. A good cleansing score was achieved in the stomach in 69.6%, in the SB in 99.1 % and in the colon in 76.6 %. Cleanliness of the whole gastrointestinal tract was good in 52.8 % of the participants. CCE median transit time of the whole gastrointestinal tract was 583 minutes IQR 303–659). The capsule reached the descending colon in 94.7 %. Median reading time per procedure was 70 minutes (IQR 57–83). Participants graded the procedure with a 7.8. There were no procedure-related SAEs. Conclusions CCE as pan-endoscopy has shown to be a safe procedure with good patient acceptance. When cleanliness of all gastrointestinal segments per patient, completion rate and reading time will be improved, CCE can be applied as a good non-invasive alternative to evaluate the gastrointestinal tract.

Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study

Background: Use of continuous glucose monitoring (CGM) systems is being rapidly adopted as standard of care for insulin-requiring patients with diabetes. The PROMISE study (NCT03808376) evaluated the accuracy and safety of the next-generation implantable Eversense CGM system for up to 180 days.Methods: This was a prospective multicenter study involving 181 subjects with diabetes at 8 USA sites. All subjects were inserted with a primary sensor. Ninety-six subjects had a second sensor, either an identical sensor or a modified sensor (sacrificial boronic acid [SBA]), inserted in their other arm (53 and 43 subjects, respectively). Accuracy was evaluated by comparing CGM to YSI 2300 glucose analyzer (Yellow Springs Instrument [YSI]) values during 10 clinic visits (day 1–180). Confirmed event detection rates, calibration stability, sensor survival, and serious adverse events (SAEs) were evaluated.Results: For primary sensors, the percent CGM readings within 20%/20% of YSI values was 92.9%; overall mean absolute relative difference (MARD) was 9.1%. The confirmed alert detection rate at 70 mg/dL was 93% and at 180 mg/dL was 99%. The median percentage of time for one calibration per day was 56%. Sixty-five percent of the primary sensors survived to 180 days. For the SBA sensors, the percent CGM readings within 20%/20% of YSI values was 93.9%; overall MARD was 8.5%. The confirmed alert detection rate at 70 mg/dL was 94% and at 180 mg/dL was 99%. The median percentage of time for one calibration per day was 63%. Ninety percent of the SBA sensors survived to 180 days. No device- or insertion/removal procedure-related SAEs were reported.Conclusion: These data show the next-generation Eversense CGM system had sustained accuracy and safety up to 180 days, with an improved calibration scheme and survival, using the primary or SBA sensors.

Stent Retriever Thrombectomy for Anterior vs. Posterior Circulation Ischemic Stroke: Analysis of the STRATIS Registry.

Background and Purpose: The benefits of mechanical thrombectomy (MT) in vertebrobasilar artery occlusions have not been well-studied. We compared clinical, procedural, and safety outcomes of MT for posterior circulation (PC) vs. anterior circulation (AC) occlusions among patients in the STRATIS registry.Methods: Data from STRATIS including patient demographics, procedural characteristics, and outcomes including symptomatic intracranial hemorrhage (sICH) at 24 h, serious adverse events (SAE), substantial reperfusion [modified thrombolysis in cerebral infarction (mTICI) 2b/3], 90-day functional independence [modified Rankin Scale (mRS) 0–2], and 90-day mortality were analyzed. Univariate logistic regression was used to calculate predictors of good clinical outcome.Results: Of 984 STRATIS patients, 43 (4.4%) patients with PC occlusions [mean age 63.0 ± 13.6, 25.6% (11/43) female] and 932 (94.7%) with AC occlusions [mean age 68.5 ± 14.8, 46.9% (437/932) female] were included for analysis. Median National Institutes of Health Stroke Scale (NIHSS) scores at baseline were 17.0 (13.0, 12.0) for the AC group and 12.0 (11.0, 24.0) for the PC group. Time from onset to procedure end was longer for the PC group [median (IQR): 322.0 min (255.0–421.0) vs. 271.0 min (207.0–360.0); p = 0.007]. PC and AC groups had similar rates of substantial reperfusion [89.2% (33/37) vs. 87.7% (684/780)], procedure-related SAE [0.0% (0/43) vs. 1.7% (16/932)], sICH [0.0% (0/38) vs. 1.5% (12/795)], 90-day functional independence [66.7% (26/39) vs. 55.9% (480/858)] and mortality [12.8% (5/39) vs. 15.8% (136/861)]. National Institutes of Health Stroke Scale score and patient sex were significant univariate predictors of good clinical outcome (p < 0.05).Conclusions: Despite longer reperfusion times, MT in PC stroke has similar rates of 90-day functional independence with no significant difference in procedure-related SAE, sICH, or mortality, supporting the use of MT in PC acute ischemic stroke (AIS).Clinical Trial Registration:https://www.clinicaltrials.gov, Identifier: NCT02239640.

Final results from the EU focal impulse and rotor modulation (E-FIRM) registry

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Background The exact pathophysiology of how pulmonary vein (PV) triggers initiate or maintain episodes of atrial fibrillation (AF) has been elusive. Catheter ablation at relatively circumscribed areas of rapidly spinning rotors or very rapid focal impulse formation can significantly affect AF. Targeted ablation of these sources using Focal Impulse and Rotor Modulation (FIRM™) shows promise. Purpose To assess the safety and effectiveness of FIRM-guided procedures for the treatment of any type of symptomatic atrial fibrillation (AF). Methods Two hundred and ninety-nine subjects were enrolled in the E-FIRM Registry at 9 clinical sites in Germany and the Netherlands. Subjects were eligible if they had reported incidence of at least 2 documented episodes of symptomatic AF during the preceding 3 months and had failed at least Class I or III anti-arrhythmia drug. Data was collected at enrollment/baseline, procedure, and at 3-, 6-, and 12-month follow-up visits. Results A majority (59.5%, 178/299) had a history of previous ablation, 81.1% (133/164) in the left side, with an average of 1.5 ± 0.8 [range 0, 5] prior ablations. The primary safety endpoint was defined as freedom from procedure related Serious Adverse Events (SAEs) through 7-days and at 12-months. At 7-days, freedom from procedure related SAEs was 94.8% (257/271). At 12-months, freedom from procedure related SAEs was 84.4% (184/218). There were no deaths. Acute effectiveness success, defined as the elimination of all identified rotors, occurred in 64.0% (165/258) of treated patients. All patients for which data was reported had at least 1 rotor identified. The most common regions to find rotors were the lateral wall of the right atrium, the anterior/septal wall of the left atrium, and the posterior inferior region of the left atrium. 75.2% (194/258) of patients had at least one rotor identified in the right atrium, and 84.1% (217/258) of patients had at least one rotor identified in the left atrium. Success was defined as two sequential endpoints: single procedure freedom from AF recurrence at 3-months and single procedure freedom from AF recurrence. At 12-months, success was achieved in 46.4% (13/28) Paroxysmal, 42.9% (87/203) Persistent, and 0% (0/9) Long Standing AF subjects. Conclusions: Since acute success was reported as being achieved in only ∼2/3 of the treated subjects, it is possible that the full potential benefit of the FIRM-guided ablation was hidden in this evaluation of the full cohort. Considering the previous ablation and disease history of subjects, a single-procedure success rate at 12-months over 40% was considered a positive result. Based on these results, FIRM-guided RF ablation in conjunction with conventional RF ablation practices is both a safe and effective treatment strategy for patients with symptomatic AF.

Abstract P3-09-19: Preliminary safety data of intrahepatic talimogene laherparepvec and intravenous atezolizumab in patients with triple negative breast cancer

Abstract Background Talimogene laherparepvec (T-VEC) is a genetically modified, oncolytic herpes simplex virus type 1 designed to selectively replicate within tumors and to produce granulocyte-macrophage colony-stimulating factor to enhance systemic antitumor immune responses. The safety and efficacy of T-VEC in treatment of advanced melanoma has been demonstrated as monotherapy and in combination with the checkpoint inhibitors (CPI) pembrolizumab and ipilimumab. Additionally, T-VEC monotherapy has demonstrated tolerable safety for intrahepatic injection (Hecht GICS 2018). Atezolizumab (atezo) is a humanized monoclonal antibody that promotes antitumor immunity by targeting programmed cell death ligand-1 (PD-L1) and is approved for metastatic triple negative breast cancer (mTNBC). We hypothesize that T-VEC in combination with a CPI may be effective in mTNBC and CRC in addition to melanoma. This phase 1b, multicenter study (clinicaltrials.gov identifier: NCT03256344) evaluates the safety of intrahepatic injection of T-VEC in combination with intravenous (IV) atezo in patients (pts) with mTNBC or colorectal cancer (CRC) with liver metastases (LMs). Here we report early safety data in the TNBC cohort. Methods Key eligibility criteria included age ≥ 18 years, confirmed diagnosis of TNBC or CRC with LMs, ECOG PS 0/1, adequate organ function, disease progression during or after ≥ 1 prior standard-of-care systemic therapy for metastatic disease, and ≥ 1 measurable LM suitable for injection. T-VEC (≤ 4mL) was injected by image-guided intralesional injection: 106 PFU/mL day 1, 108 PFU/mL every 21 days thereafter; atezo 1,200 mg IV was given on day 1 and every 21 days thereafter. The primary objective of this study is to evaluate incidence of dose limiting toxicity (DLT) for safety of T-VEC injection into LMs in combination with IV atezo, by tumor type. The DLT analysis set included DLT-evaluable pts who were on treatment for at least 6 weeks from the initial dose of study treatment and received at least 2 doses of T-VEC and 2 doses of atezo in combination or have a DLT during the DLT evaluation period. Key secondary objectives include objective response rate, durable response rate, progression-free survival, and overall survival of the combination therapy, by tumor type. Results Thirty-two pts were enrolled in two parallel cohorts (8 TNBC, 24 CRC). Of the 8 TNBC pts, 4 were evaluable for DLT at the time of this analysis. Of the 4 pts that were not DLT-evaluable, 1 never received study drug, 1 received atezo monotherapy, and 2 received intrahepatic T-VEC and IV atezo but stopped study drugs for unconfirmed progression before the DLT evaluation period was completed. No DLTs were reported in the TNBC cohort. In the 7 TNBC pts who received at least one dose of the study drug, the most common treatment-emergent adverse events (TEAEs) in terms of the subject incidence were pyrexia (71.4%), chills (42.9%), and rash (42.9%). In the 7 TNBC pts who received at least one dose of study drug, T-VEC related AEs in more than one pt were pyrexia (n=3) and chills (n=2). Atezo related AEs in more than one pt were pyrexia (n=5), chills and rash (n=3 each), and fatigue, arthralgia, pain, and pruritus (n=2 each). Study drug-related serious adverse events (SAEs) occurred in 3 (42.9%) pts, including Grade (G) 3 hypersensitivity related to atezo, G3 orthostatic hypotension related to T-VEC and atezo, and G1 pyrexia related to T-VEC and atezo. Procedure-related SAEs occurred in 1 (14.3%) pt, of G3 hepatic hematoma and G3 abdominal infection, but these were not related to the study drugs. One confirmed partial response in the TNBC cohort has been seen thus far. Conclusion T-VEC intrahepatic injection in combination with IV atezo at standard doses has thus far been demonstrated as feasible and tolerable with no DLTs observed in the TNBC cohort to date. Citation Format: Joel Randolph Hecht, Arlene Chan, Jean-Francois Baurain, Miguel Martin, Federico Longo-Munoz, Kevin Kalinsky, Steven Raman, Chunxu Liu, Edward Cha, Emily Chan. Preliminary safety data of intrahepatic talimogene laherparepvec and intravenous atezolizumab in patients with triple negative breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-09-19.

P2846Focal impulse and rotor modulation ablation versus pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation (FIRMAP AF study)

Abstract Background Based on the assumption of trigger elimination, pulmonary vein isolation (PVI) currently presents the gold standard of atrial fibrillation (AF) ablation. Recently, rapidly spinning rotors or focal impulse formation has been raised as a crucial sustaining mechanism of AF. Ablation of these rotors may potentially obviate the need for trigger elimination with PVI. Purpose This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation only with the gold standard of pulmonary vein isolation (PVI) in patients with paroxysmal AF. Methods This was a post-market, prospective, single-blinded, randomized, multi-center trial. Patients were enrolled at three centers and equally (1:1) randomized between those undergoing conventional RF ablation with PVI (PVI group) vs. those treated with FIRM-guided RF ablation without PVI (FIRM group). Data was collected at enrollment, procedure, and at 7-day, 3-month, 6-month, and 12-month follow-up visits. The study was closed early by the sponsor. At the time of study closure, any pending follow-up visits were waived. Results From February 2016 until February 2018, a total of 51 (out of a planned 170) patients (mean age 63±10.6 years, 57% male) were enrolled and randomized. Four patients withdrew from the study prior to treatment, resulting in 23 patients allocated to the FIRM group and 24 in the PVI group. Only 13 patients in the FIRM group and 11 patients in the PVI group completed the 12-month follow-up. Statistical analysis was not completed given the small number of patients. Single-procedure effectiveness (freedom from AF/atrial tachycardia recurrence after blanking period) was 52.9% (9/17) in the FIRM group and 85.7% (12/14) in the PVI group at 6 months; and 31.3% (5/16) in the FIRM group and 80% (8/10) in the PVI group at 12 months. Repeat procedures were performed in 45.8% (11/24) patients in the FIRM group and 7.4% (2/27) in the PVI group. The acute safety endpoint [freedom from procedure-related serious adverse events (SAE)] was achieved in 87% (20/23) of FIRM group patients and 100% (24/24) of PVI group patients. Procedure related SAEs occurred in three patients in the FIRM group: 1 femoral artery aneurysm and 2 injection site hematomas. No additional procedure-related SAEs were reported &gt;7 days post-procedure. Conclusions These partial study effectiveness results reinforce the importance of PVI in paroxysmal atrial fibrillation patients and suggest that FIRM-guided ablation alone (without PVI) is not an effective strategy for treatment of paroxysmal AF in most patients. Further study is needed to understand the effectiveness of adding FIRM-guided ablation as an adjunct to PVI in this patient group. Acknowledgement/Funding Abbot

976-P: Post Market Clinical Follow-Up (PMCF) Registry to Demonstrate the Long Term Safety of the Eversense CGM System

Background: Eversense CGM is the first implantable long-term continuous glucose monitoring system. Prior studies evaluated the safety of the system using a study design of one insertion and removal cycle. The purpose of this prospective PMCF registry was to assess the long-term safety of the Eversense CGM System after repeated insertions. Methods: Eversense users from 15 European countries were followed prospectively until the first 100 participants completed their 4th insertion cycle. Visits were made every 90 to 180 days (dependent on sensor configuration) to replace sensors once sensor end life was reached. At each visit, Adverse Events (AEs) that occurred during the visit or during use since the previous visit were recorded. The primary endpoint was the rate of serious adverse events (SAEs) that were device-related, procedure-related, or drug (dexamethasone acetate) related through the sensor insertion/removal cycles. Results: 3066 participants were enrolled in the study with 43% on 2 or more sensor cycles. There were no device- or procedure-related SAEs reported. A total of 130 potentially-related AEs were reported, of which 106 were adjudicated as related or possibly/probably related to the device or insertion/removal procedure. Conclusion: Repeat insertions of the Eversense CGM confirmed the promising safety profile of prior studies and show it to be safe for long-term continuous use. Disclosure G. Carlson: Consultant; Self; Abbott Laboratories, Edwards Lifesciences Corporation, Senseonics, St. Jude Medical. K.S. Tweden: Employee; Self; Senseonics. C. Mdingi: Employee; Self; Senseonics. H. Haridas: Employee; Self; Senseonics.

A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study.

Background: A prior study (PRECISE II) demonstrated that an implantable continuous glucose monitoring (CGM) system (Eversense® CGM System) provided accurate glucose readings through the 90-day sensor life with a favorable safety profile in participants with type 1 or type 2 diabetes (T1D, T2D). This study was performed to further characterize the accuracy of the system.Methods: PRECISION was a prospective multicenter study that evaluated the accuracy and safety of Eversense among adults with T1D or T2D through 90 days (NCT02647905). Accuracy measures included percentage system agreement and mean absolute relative difference (MARD) between Eversense and Yellow Springs Instrument reference measurements from 40 to 400 mg/dL. The primary safety endpoint was incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days. An updated glucose calculation algorithm was also applied to the sensor data from the PRECISE II study to evaluate consistency of accuracy results.Results: Thirty-five participants received the CGM system. Eighty-five percent of CGM values were within 15/15% of reference and the MARD value against reference was 9.6% (95% confidence interval [CI]: 8.9–10.4). All sensors were functional through day 90. No device- or procedure-related SAEs occurred. Application of the updated algorithm to PRECISE II sensor data resulted in 87% of readings within 15/15% of reference and an MARD value against reference of 8.5% (95% CI: 8.0%–9.1%).Conclusions: PRECISION corroborated prior accuracy and safety findings of the Eversense CGM System through the 90-day sensor life. The updated algorithm improved accuracy of measurements in PRECISE II.

ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study

Background and purposeThe recent randomized trials demonstrated the benefit of mechanical thrombectomy in stroke therapy. However, treatment using different strategies is an ongoing area of investigation. The PROMISE study analyzed...