Dataset Information

Efficacy and safety associated with the use of the Surfacer^® Inside-Out^® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

ABSTRACT:

Purpose

Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction.

Methods

Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5?±?12.9 (range: 30-79) years. Twenty-eight patients (93.3%) required central venous access for hemodialysis access. Locations of thoracic central venous obstruction were graded from 1 to 4 based on severity and extension of venous occlusions. Seven patients (23.3%) had type 1, 6 (20.0%) type 2, 16 (53.3%) type 3, and 1 (3.3%) type 4 obstruction.

Results

Successful central venous catheter placement was achieved in 27 of 30 patients (90.0%). The procedure was discontinued in three (10.0%) due to tortuous anatomy discovered intraprocedurally. All 27 patients with successful CVC placement achieved adequate catheter patency and tip positioning with a mean overall procedural time and time to achieve central venous access with the Surfacer System being 44.1?±?30.6 and 19.1?±?25.1?min, respectively. There were no device-related adverse events or catheter malposition.

Conclusion

The results of the SAVEUS Study confirm the safety and efficacy of the Surfacer System and the Inside-Out procedure when used for the placement of right-sided central venous access in patients with thoracic central venous obstruction.

SUBMITTER: Razavi MK

PROVIDER: S-EPMC7897784 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and safety associated with the use of the Surfacer<sup>®</sup> Inside-Out<sup>®</sup> Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

Razavi Mahmood K MK Peden Eric K EK Sorial Ehab E Ross John R JR Aruny John E JE Pflederer Timothy A TA Wasse Haimanot H Haskal Ziv J ZJ

The journal of vascular access 20200627 1

<h4>Purpose</h4>Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The <i>Surfacer System to Facilitate Access in Venous Occlusions</i> Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction.<h4>Methods</h4>Thirty patients were enrolled in th ...[more]

PMID: 32597356

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Project description:BACKGROUND:Pulmonary vein isolation is insufficient to treat all patients with persistent atrial fibrillation (AF), and effective adjunctive ablation strategies are needed. Ablation of AF drivers holds promise, but current technologies to identify drivers are limited by spatial resolution. In a single-arm, first-in-human, investigator-initiated Food and Drug Administration Investigational Device Exemption study, we used a novel system for real-time, high-resolution identification of AF drivers in persistent AF. METHODS:Patients with persistent or long-standing persistent AF underwent ablation using the RADAR (Real-Time Electrogram Analysis for Drivers of Atrial Fibrillation) system in conjunction with a standard electroanatomical mapping system. After pulmonary vein isolation, electrogram and spatial information was streamed to the RADAR system and analyzed to identify driver domains to target for ablation. RESULTS:Across 4 centers, 64 subjects were enrolled: 73% male, age, 64.7±9.5 years; body mass index, 31.7±6.0 kg/m2; left atrium size, 54±10 mm, with persistent/long-standing persistent AF in 53 (83%)/11 (17%), prior AF ablation (re-do group) in 26 (41%). After 12.6±0.8 months follow-up, 68% remained AF-free off all antiarrhythmics; 74% remained AF-free and 66% remained AF/atrial tachycardia/atrial flutter-free on or off AADs (antiarrhythmic drugs). AF terminated with ablation in 35 patients (55%) overall and in 23/38 (61%) of de novo ablation patients. For patients with AF termination during ablation, 82% remained AF-free and 74% AF/atrial tachycardia/atrial flutter-free during follow-up on or off AADs. Patients undergoing first-time ablation generally had higher rates of freedom from AF than the re-do group. CONCLUSIONS:This novel technology for panoramic mapping of AF drivers showed promising results in a persistent/long-standing persistent AF population. These data provide the scientific basis for a randomized trial. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov. Unique identifier: NCT03263702; IDE#G170049.

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Dataset Information

Efficacy and safety associated with the use of the Surfacer^® Inside-Out^® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

Purpose

Methods

Results

Conclusion

Publications

Efficacy and safety associated with the use of the Surfacer<sup>®</sup> Inside-Out<sup>®</sup> Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

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Tweets

Dataset Information

Efficacy and safety associated with the use of the Surfacer® Inside-Out® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

Purpose

Methods

Results

Conclusion

Publications

Efficacy and safety associated with the use of the Surfacer<sup>®</sup> Inside-Out<sup>®</sup> Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Efficacy and safety associated with the use of the Surfacer^® Inside-Out^® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.