Efficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months

Melvin Rosenblatt, James G. Caridi, Faris Z. Hakki, Jerry Jackson, Toros Kapoian, Samuel P. Martin, John Moran, Alexander Pedan, Woody J. Reese, John P. Ross, Jamie Lynn Ross, Fred Rushton, Steven J. Schwab, Ramesh Soundararajan, Brian Stainken, Mark A. Weiss, Jack Work, James Yegge

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

PURPOSE: To compare the performance and safety of a fully subcutaneous vascular access device, the LifeSite hemodialysis access system, versus a tunneled hemodialysis catheter, the Tesio-Cath, at 1 year after implantation. MATERIALS AND METHODS: Sixty-eight patients who required hemodialysis received implantation of the LifeSite device or a Tesio-Cath device as a part of this multicenter study. Thirty-four patients were treated in each group. The endpoints observed included blood flow rates and associated venous pressures, overall and device-related adverse events, the need for thrombolytic infusions, device-related infections (DRIs) and associated hospitalizations, and technical device survival. RESULTS: During the 12-month observation period, significantly higher venous pressures were required in patients with the Tesio-Cath to achieve blood flow rates comparable with those achieved with the LifeSite device. Patients in the LifeSite group experienced a significantly lower rate of non-device-related adverse events (P < .001), device-related adverse events (P < .016), need for thrombolytic infusions (P < .002), and DRIs (P < .013) compared with patients in the Tesio-Cath group. There was a trend toward a lower number of hospital days per month for DRIs in the LifeSite group, with the rate for the Tesio-Cath group being twice that in the LifeSite group. The use of the LifeSite device was also associated with a significantly higher probability of device survival for 12 months after censoring for planned removals (P < .031). CONCLUSIONS: The results of the present study demonstrate superior device performance and technical device survival, reduced complications, and the need for fewer interventions with the LifeSite hemodialysis access system compared with a standard hemodialysis catheter during a 1-year time period after implantation.

Original languageEnglish (US)
Pages (from-to)497-504
Number of pages8
JournalJournal of Vascular and Interventional Radiology
Volume17
Issue number3
DOIs
StatePublished - Mar 2006
Externally publishedYes

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Renal Dialysis
Catheters
Safety
Equipment and Supplies
Venous Pressure
Survival
Infection
Vascular Access Devices
Multicenter Studies
Hospitalization
Observation

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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Efficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months. / Rosenblatt, Melvin; Caridi, James G.; Hakki, Faris Z.; Jackson, Jerry; Kapoian, Toros; Martin, Samuel P.; Moran, John; Pedan, Alexander; Reese, Woody J.; Ross, John P.; Ross, Jamie Lynn; Rushton, Fred; Schwab, Steven J.; Soundararajan, Ramesh; Stainken, Brian; Weiss, Mark A.; Work, Jack; Yegge, James.

In: Journal of Vascular and Interventional Radiology, Vol. 17, No. 3, 03.2006, p. 497-504.

Research output: Contribution to journalArticle

Rosenblatt, M, Caridi, JG, Hakki, FZ, Jackson, J, Kapoian, T, Martin, SP, Moran, J, Pedan, A, Reese, WJ, Ross, JP, Ross, JL, Rushton, F, Schwab, SJ, Soundararajan, R, Stainken, B, Weiss, MA, Work, J & Yegge, J 2006, 'Efficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months', Journal of Vascular and Interventional Radiology, vol. 17, no. 3, pp. 497-504. https://doi.org/10.1097/01.RVI.0000201915.94910.54
Rosenblatt, Melvin ; Caridi, James G. ; Hakki, Faris Z. ; Jackson, Jerry ; Kapoian, Toros ; Martin, Samuel P. ; Moran, John ; Pedan, Alexander ; Reese, Woody J. ; Ross, John P. ; Ross, Jamie Lynn ; Rushton, Fred ; Schwab, Steven J. ; Soundararajan, Ramesh ; Stainken, Brian ; Weiss, Mark A. ; Work, Jack ; Yegge, James. / Efficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months. In: Journal of Vascular and Interventional Radiology. 2006 ; Vol. 17, No. 3. pp. 497-504.
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abstract = "PURPOSE: To compare the performance and safety of a fully subcutaneous vascular access device, the LifeSite hemodialysis access system, versus a tunneled hemodialysis catheter, the Tesio-Cath, at 1 year after implantation. MATERIALS AND METHODS: Sixty-eight patients who required hemodialysis received implantation of the LifeSite device or a Tesio-Cath device as a part of this multicenter study. Thirty-four patients were treated in each group. The endpoints observed included blood flow rates and associated venous pressures, overall and device-related adverse events, the need for thrombolytic infusions, device-related infections (DRIs) and associated hospitalizations, and technical device survival. RESULTS: During the 12-month observation period, significantly higher venous pressures were required in patients with the Tesio-Cath to achieve blood flow rates comparable with those achieved with the LifeSite device. Patients in the LifeSite group experienced a significantly lower rate of non-device-related adverse events (P < .001), device-related adverse events (P < .016), need for thrombolytic infusions (P < .002), and DRIs (P < .013) compared with patients in the Tesio-Cath group. There was a trend toward a lower number of hospital days per month for DRIs in the LifeSite group, with the rate for the Tesio-Cath group being twice that in the LifeSite group. The use of the LifeSite device was also associated with a significantly higher probability of device survival for 12 months after censoring for planned removals (P < .031). CONCLUSIONS: The results of the present study demonstrate superior device performance and technical device survival, reduced complications, and the need for fewer interventions with the LifeSite hemodialysis access system compared with a standard hemodialysis catheter during a 1-year time period after implantation.",
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T1 - Efficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months

AU - Rosenblatt, Melvin

AU - Caridi, James G.

AU - Hakki, Faris Z.

AU - Jackson, Jerry

AU - Kapoian, Toros

AU - Martin, Samuel P.

AU - Moran, John

AU - Pedan, Alexander

AU - Reese, Woody J.

AU - Ross, John P.

AU - Ross, Jamie Lynn

AU - Rushton, Fred

AU - Schwab, Steven J.

AU - Soundararajan, Ramesh

AU - Stainken, Brian

AU - Weiss, Mark A.

AU - Work, Jack

AU - Yegge, James

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Y1 - 2006/3

N2 - PURPOSE: To compare the performance and safety of a fully subcutaneous vascular access device, the LifeSite hemodialysis access system, versus a tunneled hemodialysis catheter, the Tesio-Cath, at 1 year after implantation. MATERIALS AND METHODS: Sixty-eight patients who required hemodialysis received implantation of the LifeSite device or a Tesio-Cath device as a part of this multicenter study. Thirty-four patients were treated in each group. The endpoints observed included blood flow rates and associated venous pressures, overall and device-related adverse events, the need for thrombolytic infusions, device-related infections (DRIs) and associated hospitalizations, and technical device survival. RESULTS: During the 12-month observation period, significantly higher venous pressures were required in patients with the Tesio-Cath to achieve blood flow rates comparable with those achieved with the LifeSite device. Patients in the LifeSite group experienced a significantly lower rate of non-device-related adverse events (P < .001), device-related adverse events (P < .016), need for thrombolytic infusions (P < .002), and DRIs (P < .013) compared with patients in the Tesio-Cath group. There was a trend toward a lower number of hospital days per month for DRIs in the LifeSite group, with the rate for the Tesio-Cath group being twice that in the LifeSite group. The use of the LifeSite device was also associated with a significantly higher probability of device survival for 12 months after censoring for planned removals (P < .031). CONCLUSIONS: The results of the present study demonstrate superior device performance and technical device survival, reduced complications, and the need for fewer interventions with the LifeSite hemodialysis access system compared with a standard hemodialysis catheter during a 1-year time period after implantation.

AB - PURPOSE: To compare the performance and safety of a fully subcutaneous vascular access device, the LifeSite hemodialysis access system, versus a tunneled hemodialysis catheter, the Tesio-Cath, at 1 year after implantation. MATERIALS AND METHODS: Sixty-eight patients who required hemodialysis received implantation of the LifeSite device or a Tesio-Cath device as a part of this multicenter study. Thirty-four patients were treated in each group. The endpoints observed included blood flow rates and associated venous pressures, overall and device-related adverse events, the need for thrombolytic infusions, device-related infections (DRIs) and associated hospitalizations, and technical device survival. RESULTS: During the 12-month observation period, significantly higher venous pressures were required in patients with the Tesio-Cath to achieve blood flow rates comparable with those achieved with the LifeSite device. Patients in the LifeSite group experienced a significantly lower rate of non-device-related adverse events (P < .001), device-related adverse events (P < .016), need for thrombolytic infusions (P < .002), and DRIs (P < .013) compared with patients in the Tesio-Cath group. There was a trend toward a lower number of hospital days per month for DRIs in the LifeSite group, with the rate for the Tesio-Cath group being twice that in the LifeSite group. The use of the LifeSite device was also associated with a significantly higher probability of device survival for 12 months after censoring for planned removals (P < .031). CONCLUSIONS: The results of the present study demonstrate superior device performance and technical device survival, reduced complications, and the need for fewer interventions with the LifeSite hemodialysis access system compared with a standard hemodialysis catheter during a 1-year time period after implantation.

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