A Novel Inside-out Access Approach for Hemodialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Reindl‐Schwaighofer, Roman; Matoussevitch, Vladimir; Winnicki, Wolfgang; Калмыков, Е.Л.; Gilbert, James; Matzek, Wolfgang; Sengölge, Gürkan

doi:10.1053/j.ajkd.2019.08.024

Cited by 29 publications

(31 citation statements)

References 30 publications

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“…Patient monitoring was limited to 7-day post-procedure per study definitions and requirements. As in other series, 10–12 there was a limited number of patients with type 4 obstructions in this patient population. The distribution of the obstruction types treated in the present study is reflective of the epidemiology of type 4 lesions and hence enrollment in this study is representative of the general population of patients with TCVO who need CVC.…”

Section: Discussionsupporting

confidence: 70%

“…The results from the present study are consistent with those reported in conjunction with the use of the Surfacer device in other retrospective patient series. 10–12 Reindl-Schwaighofer et al 10 recently reported on a larger series of patients where the device was used successfully to establish CVA in 38 of 39 (97%) attempted procedures in hemodialysis patients with TCVO. This included seven patients in which the Surfacer procedure was repeated due to failure of the CVC and inability to change out the catheter during the study observation.…”

Section: Discussionmentioning

confidence: 99%

“…The device permits entry and placement of CVCs for patients with upper body venous obstructions that preclude conventional CVA by using the percutaneous, endovascular inside-out CVA placement technique. 10–12 In this article, we report the results from a prospective, multicenter, single-arm study designed to evaluate the safety and efficacy of the Surfacer device in patients with TCVO.…”

Section: Introductionmentioning

confidence: 99%

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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

Razavi¹,

Peden

Sorial

et al. 2020

J Vasc Access

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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.

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Section: Discussionsupporting

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

Razavi¹,

Peden

Sorial

et al. 2020

J Vasc Access

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“…This includes the SAVE Registry and the FDA-IDE study, both enrolling 30 patients with a reported high technical success and no device-related complications. [7][8][9]15 Similar to these previous reports, we had difficulty with initial insertion of the device workstation in 1 patient due to the tortuosity of the iliac vein in 1 patient. While this problem was overcome through the use of a larger sheath and an extra stiff guidewire to reinforce the passage of the device through the iliac junction, it highlights more the need to perform appropriate pre-procedural imaging studies and to continually assess the device's location in relationship to the patient's anatomy as it is being advanced.…”

Section: Discussionsupporting

confidence: 68%

“…Prospective studies to date have reported the Surfacer Inside-Out procedure provides an effective and safe alternative to restoring right-sided CVA in patients with TCVO. [7][8][9] While these studies provide insights on procedural outcomes associated with the use of the Surfacer System, there is limited information reported on patient vascular access history prior to the use of the device.…”

Section: Introductionmentioning

confidence: 99%

Use of the Surfacer® Inside-Out® Catheter Access System to Obtain Central Venous Access in Dialysis Patients With Thoracic Venous Obstructions: Single-Center Series

Galas

Shahverdyan

2020

Vasc Endovascular Surg

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Background: Thoracic central venous obstruction (TCVO) is a common condition which can impact the ability to achieve central venous access (CVA) in patients on hemodialysis. The Surfacer® Inside-Out® Catheter Access System is designed to enable repeated right-side central venous access in patients with TCVO. Methods: We retrospectively analyzed medical records of 10 dialysis patients who presented with TCVO and underwent the Inside-Out procedure with the Surfacer System to obtain CVA between 2017 and 2020. Patient demographics, hemodialysis vascular access history, and procedural data were identified and analyzed. The mean patient age was 62.4 ± 19.6 years (25.9-89.1 years) with 7 of the 10 patients being male. Eight patients (80.0%) were diagnosed with chronic kidney disease with time on hemodialysis ranging from 3 to 13 years. The remaining 2 required CVA to treat acute-on-chronic kidney injury due to septic shock. Patients in our series had a mean of 2.8 ± 1.6 previous catheters placed prior to the Surfacer procedure. Results: CVA was achieved in all 10 patients with 1 patient requiring a second attempt to achieve access due to the inability to initially traverse the iliac vein with the device, possibly due to a history of kidney transplantation. One multimorbid patient died shortly after the successful procedure, possibly due to cardiac decompensation. Mean total procedure time for the 7 patients having only dialysis catheter placement using the Surfacer device was 67.2 ± 19.1 minutes (49-103 minutes). The remaining 3 patients received a Hemodialysis Reliable Outflow (HeRO) graft in conjunction with the Inside-Out procedure. All vascular accesses functioned properly during the immediate time period following placement. No adverse events associated with the use of Surfacer device were encountered. Conclusions: Data presented from our patient series confirms the effectiveness of the Surfacer System to safely achieve CVA in dialysis patients with TCVOs with a history of multiple catheter placements.

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“Inside‐Out” Central Venous Access approach with infraclavicular exit for right‐sided CRT‐D Implantation in bilateral brachiocephalic and superior vena cava occlusion

Tonko

Black

Rinaldi

2021

Clinical Case Reports

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A Novel Inside-out Access Approach for Hemodialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Cited by 29 publications

References 30 publications

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

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

Use of the Surfacer® Inside-Out® Catheter Access System to Obtain Central Venous Access in Dialysis Patients With Thoracic Venous Obstructions: Single-Center Series

“Inside‐Out” Central Venous Access approach with infraclavicular exit for right‐sided CRT‐D Implantation in bilateral brachiocephalic and superior vena cava occlusion

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A Novel Inside-out Access Approach for Hemodialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Cited by 29 publications

References 30 publications

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

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

Use of the Surfacer® Inside-Out® Catheter Access System to Obtain Central Venous Access in Dialysis Patients With Thoracic Venous Obstructions: Single-Center Series

“Inside‐Out” Central Venous Access approach with infraclavicular exit for right‐sided CRT‐D Implantation in bilateral brachiocephalic and superior vena cava occlusion

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Product

Resources

About

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

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