Use of Paclitaxel-Coated Balloon Catheter Dilation to Reduce In-Stent Restenosis in Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Abstract

Purpose: Paclitaxel-coated balloons (PCB) inhibit neointimal proliferation in arteries. The purpose of this retrospective analysis was to investigate the effect of PCB in in-stent restenosis after transjugular intrahepatic portosystemic shunt (TIPS) in patients with cirrhotic liver disease.

Materials and Methods: Six patients (mean age: 65 ± 10 years) with recurrent in-stent restenoses in TIPS (5 bare stents, 1 covered stent) underwent a single percutaneous transluminal angioplasty (PTA) with PCB (3 µg paclitaxel/mm²). Post-interventional outcome and patency were compared with those of prior plain optimal balloon angioplasty (POBA) in the same patients. During a two-year follow-up period, all patients underwent angiographic examinations at 6-month intervals. In-stent minimal lumen diameter (MLD) and late lumen loss (LLL) were assessed. Paclitaxel residues on balloon and sheath surfaces as well as venous plasma concentrations (0 – 24 hours) were analyzed.

Results: PCB decreased the need for clinically driven repeat PTA (POBA: 53 % of angiographic examinations; paclitaxel PTA: 19 %; P = 0.014). LLL/diameter stenosis was higher after POBA (2.4 ± 1.5 mm/28 ± 18 %) than after PCB (0.5 ± 0.8 mm/7 ± 11 %, P = 0.029). Residual paclitaxel on balloons was 28 ± 9 % of dose and 0.2 ± 0.1 % on sheath surfaces. Paclitaxel plasma concentrations were below detectable levels throughout the first 24 hours after the interventions in all patients. The procedure was well tolerated and no clinical side effects attributable to paclitaxel were observed.

Conclusion: In patients with recurrent in-stent stenoses, a single PTA with PCB resulted in a prolonged secondary patency due to pseudointimahyperplasia without a systemic effect of paclitaxel.

Key points:

• Intimahyperplasia is a common reason for long-time TIPS dysfunction

• First-in-man local paclitaxel application in TIPS patients with recurrent in-stent stenoses

• PTA with PCB resulted in a prolonged secondary patency compared to POBA

• No systemic effects of Paclitaxel were detected

Citation Format:

• Marticorena Garcia SR, Langmann M, Schnorr B et al. Use of Paclitaxel-Coated Balloon Catheter Dilation to Reduce In-Stent Restenosis in Transjugular Intrahepatic Portosystemic Shunt (TIPS). Fortschr Röntgenstr 2016; 188: 374 – 380

Zusammenfassung

Ziel: Paclitaxel-beschichtete Ballonkatheter (PCB) vermindern die Neointimaproliferation in Arterien. Das Ziel dieser retrospektiven Analyse war es, den Effekt von PCB in In-Stent-Restenosen durch Pseudointimahyperplasie nach transjugulärem intrahepatischen portosystemischen Shunt (TIPS) zu untersuchen.

Material and Methoden: Sechs Patienten (mittleres Alter, 65 ± 10 Jahre) mit rezidivierenden In-Stent-Stenosen im TIPS (5 „Bare-Metal-Stents“, 1 ummantelte Endoprothese) erhielten eine einzelne perkutane transluminale Angioplastie (PTA) mit PCB (3 µg Paclitaxel/mm²). Das postinterventionelle Outcome und die Offenheitsrate wurden innerhalb des Patientenkollektives mit vorangegangenen unbeschichteten PTAs (POBA) verglichen. Während einer Zeitperiode von 2 Jahren wurden die Patienten im Abstand von 6 Monaten klinisch und angiografisch kontrolliert. Die kürzesten In-Stent-Lumendurchmesser (MLD) und das „Late lumen loss“ (LLL) wurden bestimmt. Residuelles Paclitaxel wurde auf den Ballonkathetern, den Schleusen und in venösen Blutproben (0 – 24 Stunden) analysiert.

Ergebnisse: PCB verminderte die Notwendigkeit für klinisch indizierte, Re-PTAs (POBA, 53 % der Angiografien; Paclitaxel PTA, 19 %, P = 0,014). Das LLL der Stenosen war nach POBA größer (2,4 ± 1,5 mm/28 ± 18 %) im Vergleich zu den PTAs mit PCB (0,5 ± 0,8 mm/7 ± 11 %, P = 0,029). 28 ± 9 % der applizierten Paclitaxel-Konzentration wurde residuell auf den Oberflächen der Ballonkatheter und 0,2 ± 0,1 % auf den Oberflächen der Schleusen beobachtet. Paclitaxel-Plasmakonzentrationen lagen innerhalb der ersten 24 Stunden nach den Interventionen unterhalb der Detektionsgrenze. Es wurden keine Paclitaxel assoziierten Nebenwirkungen beobachtet.

Schlussfolgerung: Die singuläre PTA mit einem Paclitaxel-beschichteten Ballon führt zu einer verbesserten sekundären Offenheitsrate bei TIPS-Dysfunktion durch Pseudointimahyperplasie ohne dabei Paclitaxel bedingte systemische Effekte zu verursachen.

Kernaussagen:

• Intimahyperplasie ist Ursache für langfristige Shunt-Dysfunktionen.

• Erstmaliger Bericht über lokale Paclitaxel-Applikation bei Patienten mit rezidivierenden Stenosen im TIPS zur Reduktion der Pseudointimahyperplasie.

• Eine PTA mit PCB verlängert die sekundäre Offenheitsrate des TIPS im Vergleich zur normalen PTA.

Key words

portosystemic shunt - transjugular intrahepatic balloon angioplasty - paclitaxel

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