APERTO OTW®

Paclitaxel Releasing Hemodialysis
Shunt Balloon Dilatation Catheter

Selected patient case reports from the multi-center APERTO clinical trial program of Cardionovum.

Case 1
12 month FU-Shunt-Patency.

Patient description:
FMG is a white male, born in 1978, CKD 5d treated by in-center hemodialysis since 2009.
He is now being dialysed through his 2nd AV Fistula, a Brachio-Cephalic fistula placed in May 2011, refer-red for angiography in May 2014 due to a twice con-firmed sudden drop of the vascular access flow (Qa) of 50%, from 1080ml/min to 500ml/min, no fistula collapse on arm elevation and a reduction of Kt/V.
This was the third referral to the angiography suite within 3 months intervals due to recurrence of severe stenosis (more than 80% of the vein lumen) in the ce-phalic vein arch.

Treatment:
This time we decided to use a Paclitaxel coated balloon (Cateter Balão APERTO 6.0 mm x 40 mm 40 cm - APS 6.0-40) 6 mm x 4 cm, inflated for 2 min after standard balloon angioplasty with a 8 mm balloon up to 30 atm.

Result:
We obtained a good anatomical result, the Qa measured next dialysis went up to 1160ml/min and, so far, more than 300 days later, there was no clinical or hemodynamic signs of recurrence.

Post-dilatation: Angiography after successful APERTO DEB dilatation. 12 month FU-Shunt-Patency.

Pre-dilatation: Angiography evidence of severe stenosis of the cephalic arch.

Treatment: Balloon inflation resolving the stenotic lesion.

Case 2
7 month FU-Shunt-Patency.

Patient description:
JFC is a white male, born in 1934, long standing diabetes and hypertension, CKD 5d treated by in-center hemodi-alysis since April 2011.

He is now being dialysed through his 1st AV Fistula, a left arm Brachio-Cephalic fistula placed in May 2011, referred for angiography in May 2014 due to recurrence of arm edema, access pounding pulse, with a stable vascular access flow (Qa) of 1170ml/min, 10% total recirculation and a spKt/V of 1.7.

This was the 10th referral to the angiography suite of this same access. The recurrent finding is a severe ste-nosis of the subclavian vein immediately before joining the internal jugular vein and a second lesion of the bra-chiocephalic vein before joining the contralateral vein.

This lesions were dilated once more with a 14 mm balloon in November 2013, the arm edema (and both lesions) recurred in January 2014 and in that procedure a Wallstent was deployed.

Treatment:
Now, 4 months later, arm edema again, with stenosis recurrence in the pre-stent area. It was decided to use a Paclitaxel coated balloon (Cateter Balão APERTO 6.0 mm x 40 mm 40 cm - APS 6.0-40) 6 mm x 4 cm, inflated for 2 min, after standard balloon angioplasty with a 12 mm balloon up to 22 atm.

Result:

A good anatomic result was obtained, Qa went up to 1330ml/min, arm edema resolved once more. A new recurrence with referral to angiography occurred 207 days later, the lesion was dilated again, the same AV fistula is still this patient vascular access.

Post-dilatation: Angiography after successful APERTO DEB dilatation. 7 month FU-Shunt-Patency.

Pre-dilatation: Angiography of stenosis Subclavia.

Pre-dilatation: Angiography of cen-tral stenosis, AV-Fistula, left arm.

Treatment: Balloon inflation resolving the stenotic lesion.

Case 3
12 month FU. Ongoing Shunt-Patency.

Patient description:

ACP is a white female, born in 1931, CKD 5d treated by in-center hemodialysis since 2012

She is now being dialysed through her 1st Brachio-Ba-silic PTFE graft created in Frebruary 2012, referred for angiography in December 2014 due to a twice confir-med sudden drop of the vascular access flow (Qa) of 65%, from 1710ml/min to 610ml/min in 1 month, without reduction of dialysis adequacy (OCM Kt/V).

Treatment:
This time it was decided to use a Paclitaxel coated bal-loon (Catheter APERTO 8.0 mm x 40 mm 40 cm - APS 8.0-40), inflated for 2 min after standard balloon angio-plasty with a conventional 8 mm x 60 mm balloon up to 27 atm.

Result:

We obtained a good anatomical result, the Qa measured by thermic dilution (BTM ©) next dialysis went up to 1060ml/min and, so far – April 2014, there was no clinical or hemodynamic signs of recurrence, and the measured Qa is still 840ml/min.

Post-dilatation: Venöse Anastomose after successful APERTO DEB dilatation. 12 month FU-Shunt-Patency.

Pre-dilatation: Severe stenosis recurrence of the PTFE venous anastomosis.

Pre-dilatation: PTFE graft and its arterial anastomosis.

Case 4
12 month FU. Ongoing Shunt-Patency.

Patient description:
CEF is a white female, born in 1966, CKD 5d treated by in-center hemodialysis since 1999, HCV +, with severe cardio-vascular comorbidities.

She is now being dialysed through her 3rd PTFE graft, this one from the right femoral artery to the right femoral vein, crea-ted in May 2013, referred for angiography in December 2014 due to severe edema of the right lower limb, without reduc-tion of dialysis adequacy (OCM Kt/V).

This was the fourth referral of this vascular access to the an-giography suite (February 2014, June 2014 and September 14) always due to recurrence of severe edema of the access limb, revealing a long and severe stenosis up to a total stop of the external iliac vein immediately after the PTFE venous anastomosis.

Treatment:
This time, due to repeated short-term recurrences, it was decided to use a Paclitaxel coated balloon, actually 2 balloons as the stenotic segment was longer than 4cm (Catheter APERTO 8.0 mm x 40 mm 40 cm - APS 8.0-40), inflated for 2 min after standard balloon angioplasty with a conventional 10 mm x 80 mm balloon up to 27 atm.

Result:

A good anatomical and functional result was obtained, with edema resolution in the next few days, and so far, April 2014, there was no clinical or hemodynamic signs of recurrence.

Post-dilatation: Venous anastomosis and external iliac vein post-procedure.

Pre-dilatation: PTFE loop in the right lower limb.

Pre-dilatation: Angioplasty of the external iliac vein.

Pre-dilatation: PTFE venous anastomosis with a total stop of the external iliac vein above the anastomosis.