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Frederic S. Resnic - One of the best experts on this subject based on the ideXlab platform.

  • Vascular Closure Device Failure in Contemporary Practice
    JACC. Cardiovascular interventions, 2012
    Co-Authors: Venkatesan Vidi, Sripal Bangalore, Michael E. Matheny, Usha Govindarajulu, Sharon-lise T. Normand, Susan Robbins, Vikram Agarwal, Frederic S. Resnic
    Abstract:

    Objectives The goal of this study was to assess the frequency and predictors of vascular closure Device (VCD) deployment Failure, and its association with vascular complications of 3 commonly used VCDs. Background VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD Failure, and the association of deployment Failure with vascular complications. Methods From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug–based (n = 18,533), a nitinol clip–based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD Failure as unsuccessful deployment or Failure to achieve immediate access site hemostasis. Results Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug–based, 6.1% of suture-based, 9.5% of nitinol clip–based VCDs). Patients with VCD Failure had an excess risk of “any” (7.7% vs. 2.8%; p Conclusions VCD Failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.

  • Vascular Closure Device Failure: Frequency and Implications: A Propensity-Matched Analysis
    Circulation. Cardiovascular interventions, 2009
    Co-Authors: Sripal Bangalore, Nipun Arora, Frederic S. Resnic
    Abstract:

    Background —Vascular closure Devices (VCDs) are effective in reducing the time to ambulation for patients undergoing cardiac catheterization procedures and in reducing the risk of vascular complications in selected patient cohorts. However, the frequency and consequence of Failure of VCDs is not well defined. Methods and Results —From a prospective registry of consecutive patients undergoing cardiac catheterization at our center, 9823 patients who received either a collagen plug-based (Angio-Seal) or a suture-based (Perclose) VCD were selected for the study. VCD Failure was defined as unsuccessful deployment or Failure to achieve hemostasis. Major vascular complication was defined as any retroperitoneal hemorrhage, limb ischemia, or any surgical repair. Minor vascular complication was defined as any groin bleeding, hematoma (≥5 cm), pseudoaneurysm, or arteriovenous fistula. Any vascular complication was defined as either a major or minor vascular complication. Among the 9823 patients in the study, VCD failed in 268 patients (2.7%; 2.3% diagnostic versus 3.0% percutaneous coronary intervention; P =0.029). Patients with VCD Failure had significantly increased risk of any (6.7% versus 1.4%; P

  • vascular closure Device Failure frequency and implications a propensity matched analysis
    Circulation-cardiovascular Interventions, 2009
    Co-Authors: Sripal Bangalore, Nipun Arora, Frederic S. Resnic
    Abstract:

    Background —Vascular closure Devices (VCDs) are effective in reducing the time to ambulation for patients undergoing cardiac catheterization procedures and in reducing the risk of vascular complications in selected patient cohorts. However, the frequency and consequence of Failure of VCDs is not well defined. Methods and Results —From a prospective registry of consecutive patients undergoing cardiac catheterization at our center, 9823 patients who received either a collagen plug-based (Angio-Seal) or a suture-based (Perclose) VCD were selected for the study. VCD Failure was defined as unsuccessful deployment or Failure to achieve hemostasis. Major vascular complication was defined as any retroperitoneal hemorrhage, limb ischemia, or any surgical repair. Minor vascular complication was defined as any groin bleeding, hematoma (≥5 cm), pseudoaneurysm, or arteriovenous fistula. Any vascular complication was defined as either a major or minor vascular complication. Among the 9823 patients in the study, VCD failed in 268 patients (2.7%; 2.3% diagnostic versus 3.0% percutaneous coronary intervention; P =0.029). Patients with VCD Failure had significantly increased risk of any (6.7% versus 1.4%; P <0.0001), major (1.9% versus 0.6%; P =0.006), or minor (6.0% versus 1.1%; P <0.0001) vascular complication compared with the group with successful deployment of VCD. The increased risk of vascular complication was unchanged in a propensity score-matched cohort. Conclusions —In contemporary practice, VCD Failure is rare, but when it does fail, it is associated with a significant increase in the risk of vascular complications. Patients with VCD Failure should be closely monitored.

Michael A. Gaglia - One of the best experts on this subject based on the ideXlab platform.

Melville Da Cruz - One of the best experts on this subject based on the ideXlab platform.

  • rates of revision and Device Failure in cochlear implant surgery a 30 year experience
    Laryngoscope, 2014
    Co-Authors: Jeffrey T Wang, Allen Y Wang, Colleen Psarros, Melville Da Cruz
    Abstract:

    Objectives/Hypothesis To characterize revision cochlear implant surgery and quantify rates of revision and Device Failure. Study Design Retrospective review of 235 cases of revision cochlear implant surgery performed at the Sydney Cochlear Implant Center over a period of 30 years, between January 1982 and June 2011. Methods Patient demographics and characteristics of revision surgery were retrospectively extracted from a centralized database. Analyses of overall and cumulative rates were performed. Results During the study period, 2,827 primary cochlear implantations were performed in 2,311 patients, with 201 primary implants in 191 patients of this cohort (109 children and 82 adults) undergoing 235 revision surgeries. The most common indication for revision surgery was Device Failure (57.8%), followed by migration/extrusion (23.4%), infection/wound complication (17.0%), and poor outcome/secondary pathology (6.4%). The majority of revision surgeries were reimplantations. Overall revision and Device Failure rates were 8.3% and 4.8%, respectively. The cumulative revision rate for primary implants at all ages increased linearly by 1% per year. The cumulative revision rate was significantly higher in children, and decreased with more recently performed implantations and with newer generations of implants. Conclusions The cumulative revision rate for primary implants suggests an ongoing linear relationship between the time of postprimary implantation and the need for revision surgery. We have formed an evidence base that characterizes the nature and frequency of revision surgery in a high-volume setting, allowing clinicians to effectively counsel prospective patients and clinics to understand the burden of revision surgery and Device Failure. Level of Evidence 4 Laryngoscope 124:2393–2399, 2014

Arie Steinvil - One of the best experts on this subject based on the ideXlab platform.

  • Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure Device Failure during transcatheter aortic valve replacement.
    Cardiovascular revascularization medicine : including molecular interventions, 2016
    Co-Authors: Arie Steinvil, Nelson L. Bernardo, Toby Rogers, Eddie Koifman, Kyle Buchanan, M. Chadi Alraies, Christian Shults, Rebecca Torguson, Petros Okubagzi, Augusto D. Pichard
    Abstract:

    Abstract Objectives Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure Device Failure following transcatheter aortic valve replacement (TAVR). Background Access site–related vascular complications (VC) following sheath removal related to pre-closure Device Failure during TAVR are common and treatment options may vary. Methods We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015. Results Included were 25 patients at a mean (±SD) age of 82 ± 9. Failure of the closure Device resulted in overt bleeding in 19 patients, dissection or no flow in 5 patients, and angiographic pseudoaneurysm in 1. Overall 29 stents were deployed with diameters ranging from 8 to 11 mm and a length of 50 mm (26, 90%). All stent-graft deployments achieved complete hemostasis of the arteriotomy site and resulted in normal flow to the distal vessels. None of the patients required open surgical repair. The mean hemoglobin drop was 2.6 ± 1.3 g/dl. Blood transfusions were used in 15 (60%) patients. Acute kidney injury occurred in 4 (16%) patients, none of whom was treated with dialysis. Length of hospital stay was 9 ± 5 days. All patients survived during a 30-day follow-up period, and none had VC related to the stented site. Conclusions The use of an ePTFE-covered Nitinol self-expanding stent graft is a feasible, safe, and effective treatment modality for access site–related VC following TAVR. Summary The use of an ePTFE-covered nitinol self-expanding stent graft placed in the common femoral artery for the treatment of suture-mediated pre-closure Device Failure following transcatheter aortic valve replacement (TAVR) is described in 25 patients. Its use was found to be feasible, safe, and an effective treatment modality for access site-related vascular complications following TAVR.

  • CRT-400.18 Use of a Self Expandable Nitinol Stent Graft as Treatment for Pre Closure Device Failure During Transcatheter Aortic Valve Replacement
    JACC: Cardiovascular Interventions, 2016
    Co-Authors: Arie Steinvil, Nelson L. Bernardo, Hector M. Garcia-garcia, Toby Rogers, Sarkis Kiramijyan, Eddie Koifman, Smita I. Negi, Sang Yeub Lee, Michael J. Lipinski, Michael A. Gaglia
    Abstract:

    Access site related vascular complications (VC) following sheath removal related to pre-closure Device Failure during transcatheter aortic valve replacement (TAVR) are common and treatment options may vary. We describe our experience with the use of a self-expandable nitinol stent graft (GORE®

Simon A Angeli - One of the best experts on this subject based on the ideXlab platform.

  • incidence and indications for revision cochlear implant surgery in adults and children
    Laryngoscope, 2009
    Co-Authors: Kevin D Brown, Sarah S Connell, Thomas J Balkany, Adrien E Eshraghi, Fred F Telischi, Simon A Angeli
    Abstract:

    Objectives/Hypothesis: To identify the incidence of and common causes for cochlear implant revision. Study Design: Retrospective case series. Methods: Operative records were reviewed for all cases of revision cochlear implantation from 1992 to 2006. The causes for reimplantation were classified as hard Device Failure, soft Device Failure, exposure/infection, receiver/stimulator migration, and electrode migration. Manufacturers' Failure analysis of explanted Devices was likewise determined. Results: Eight hundred and six cochlear implants were performed during the study period including 44 (5.5%) revision procedures. The revision rate was 7.3% for children and 3.8% for adults and reached statistical significant difference. The most common reasons for revision were Device Failure (78%; 55% hard Failure, 23% soft Failure) followed by electrode migration (9%) and receiver/stimulator migration (7%). Manufacturers' analysis of failed Devices revealed loss of hermetic seal and cracked cases to be the most common causes of Failure. Bench analysis of 5/10 explanted Devices that were soft Failures demonstrated identifiable Device defects. Conclusions: Revision cochlear implant surgery is an infrequent occurrence. Its incidence appears to be higher in children than in adults, although in this series does not appear to be due to increased wound complications, infections, or trauma. Explanted implants that have soft Failure as the etiology may have demonstrable defects on bench testing. Laryngoscope, 119:152–157, 2009