scholarly journals 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

2020 ◽  
pp. 112972982093712 ◽  
Author(s):  
Mahmood K Razavi ◽  
Eric K Peden ◽  
Ehab Sorial ◽  
John R Ross ◽  
John E Aruny ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Central Venous Access ◽  
Venous Access ◽  
Venous Obstruction ◽  
Central Venous ◽  
Investigational Device Exemption ◽  
Inside Out ◽  
Central Venous Obstruction

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.

The Surfacer® Inside-Out® Access System for right-sided catheter placement in dialysis patients with thoracic venous obstruction

2019 ◽  
Vol 21 (4) ◽  
pp. 411-418 ◽  
Author(s):  
Dirk M Hentschel ◽  
Laura Minarsch ◽  
Félix Vega ◽  
Adrian Ebner
Keyword(s):  
Central Venous Access ◽  
Patient Characteristics ◽  
Low Complexity ◽  
Venous Access ◽  
Catheter Placement ◽  
Dialysis Patients ◽  
Venous Obstruction ◽  
Central Venous ◽  
The Right ◽  
Central Venous Obstruction

Purpose: Thoracic central venous obstruction is a common clinical complication in dialysis patients utilizing hemodialysis catheters. Thoracic central venous obstruction can lead to inability to utilize affected veins for catheter placement and sequential use of less preferred alternative venous access sites. The latter can affect the ability to create and/or mature permanent arteriovenous access and contribute to the future loss of thoracic veins for venous access. While alternative procedures exist for gaining venous access in patients who have exhausted routine venous access options, these procedures are complex, time-consuming, and associated with high patient risk. The Surfacer System provides a new approach in patients with right-sided thoracic central venous obstruction, enabling the ability to establish repeated access from the right side of the neck to the right atrium. Methods: We describe the use of the Surfacer System to facilitate placement of hemodialysis catheters in a series of nine patients with thoracic central venous obstruction involving one or more central veins. Patient characteristics and procedure-related outcomes were recorded for all patients. Results: Central venous access was successfully achieved in eight of nine patients using the Surfacer System. Significant venous tortuosity resulted in the inability to achieve venous access in one patient and prolonged procedural time to achieve access in another patient. The mean time required for Surfacer-related procedural steps and associated fluoroscopy time in the remaining seven patients was 13.3 and 3.7 min, respectively. Conclusion: The Surfacer System provides an efficient low-complexity alternative for gaining repeated right-sided central venous access in hemodialysis patients with obstructed thoracic veins.

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

2020 ◽  
pp. 153857442098060
Author(s):  
Noemi Galas ◽  
Robert Shahverdyan
Keyword(s):  
Central Venous Access ◽  
Kidney Injury ◽  
Venous Access ◽  
Iliac Vein ◽  
Dialysis Patients ◽  
Central Venous ◽  
Access System ◽  
Cardiac Decompensation ◽  
History Of ◽  
Inside Out

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.

Upper Extremity Impedance Plethysmography in Patients with Venous Access Devices

1994 ◽  
Vol 72 (04) ◽  
pp. 540-542 ◽  
Author(s):  
McDonald K Horne ◽  
Donna Jo Mayo ◽  
Richard Alexander ◽  
Elizabeth P Steinhaus ◽  
Richard C Chang ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Upper Extremity ◽  
Central Venous Access ◽  
Venous Access ◽  
Impedance Plethysmography ◽  
Venous Obstruction ◽  
Central Venous ◽  
Venous Outflow ◽  
Complete Obstruction ◽  
Venous Access Devices

SummaryCentral venous access devices (VADs) are often associated with thrombotic obstruction of the axillary-subclavian venous system. To explore the accuracy of impedance plethysmography (IPG) in identifying this complication we performed IPG on 35 adult cancer patients before their VADs were placed and approximately 6 weeks later. At the time of the second IPG the patients also underwent contrast venography of the axillary-subclavian system. The venograms revealed partial venous obstruction in 12 patients (34%) and complete obstruction in two (5.7%). Although the IPG results from venographically normal and abnormal patients overlapped extensively, mean measurements of venous outflow were significantly lower in the patient population with abnormal venograms (P = 0.052 for Vo; P = 0.0036 for Vo/Vc). In our hands, therefore, upper extremity IPG cannot be used to make clinical decisions about individual patients with VADs, but it can distinguish venographically normal and abnormal populations.

scholarly journals Novel experience of laser-assisted ‘inside-out’ central venous access in a patient with bilateral subclavian vein occlusion requiring pacemaker implantation

EP Europace ◽  
2016 ◽  
pp. euw239
Author(s):  
Thandar Aye ◽  
Thanh Trung Phan ◽  
Douglas Findlay Muir ◽  
Nicholas John Linker ◽  
Richard Hartley ◽  
...  
Keyword(s):  
Subclavian Vein ◽  
Central Venous Access ◽  
Pacemaker Implantation ◽  
Venous Access ◽  
Central Venous ◽  
Vein Occlusion ◽  
Inside Out

scholarly journals A novel technique to restore access in patients with central venous occlusion using the Surfacer® Inside-Out® Access Catheter System

2020 ◽  
Vol 21 (5) ◽  
pp. 778-782
Author(s):  
Tarik R Baetens ◽  
Joris I Rotmans ◽  
Rutger W van der Meer ◽  
Carla SP van Rijswijk
Keyword(s):  
San Antonio ◽  
Central Venous Access ◽  
Venous Access ◽  
Venous Occlusion ◽  
Central Venous ◽  
Catheter System ◽  
Life Threatening ◽  
Central Venous Occlusion ◽  
Threatening Situation ◽  
Inside Out

Exhausted central venous access is a potentially life-threatening situation for patients dependent on haemodialysis. If standard guidewire recanalisation fails, unconventional venous access or central venous needle recanalisation can be considered but are often associated with higher rates of complications and/or dysfunction. Here, we report about two patients treated successfully with the Surfacer® Inside-Out® Access Catheter System (Bluegrass Vascular Technologies, San Antonio, TX, USA) to achieve transmediastinal central venous access.

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