Complicati ons of Tre atment of Severe Spasticity with Implantable Pump Systems

Česká verzia

Authors: I. Štětkářová ¹; I. Vrba ²; J. Peregrin ¹; J. Šro ubek ³
Authors place of work: Ne urologické oddělení Nemocnice Na Homolce, Praha ¹; ARO Nemocnice Na Homolce, Praha ²; Ne urochirurgické oddělení Nemocnice Na Homolce, Praha ³
Published in the journal: Cesk Slov Neurol N 2008; 71/104(4): 458-465
Category: Short Communication

Práce byla podpořena grantem IGA MZ ČR NR- 8523-3 a částečně výzkumným záměrem MSM0021620849.

Summary

Objective:
Severe spasticity as a result of a central nervo us system affecti on is difficult to influence by standard therapi es in a number of cases. In recent ye ars, continuo us administrati on of baclofen in the intrathecal space using pump systems has proven effective. The main indicati on criteri on for the implantati on of a pump is a positive response to a single intrathecal administrati on of baclofen. After the implantati on of the pump system, the effici ent dose is titrated and after that the pump’s reservo ir is refilled on a regular basis. Possible pump system complicati ons are classifi ed into pharmacological complicati ons, problems associ ated with the implantati on of the system, and complicati ons related to the activity of the system as such. The study provides a list of complicati ons and the respective soluti ons appli ed in o ur set of pati ents.

Materi al and methods:
The effect of intrathecally administered baclofen was tested in 19 pati ents with severe spasticity and in one pati ent with generalised dystoni a. Based on the effect of tested baclofen, we subsequently implanted pump systems to nine persons with multiple sclerosis and five persons with a chronic spinal injury. An X‑ray or a CT was performed in all cases to specify the positi on of the catheter; in one pati ent, also CT myelography was performed. In order to check the thro ughput of the catheter, a contrast substance was appli ed by the lateral port of the pump in two pati ents.

Results:
Transitory cephale a and hypotensi on were recorded in two persons after single intrathecal administrati on of baclofen. During implantati on and in the peri od which followed, complicati ons were recorded in six persons. They were: overdosing with baclofen (one person), local infecti on (one person), liquor le akage (one person) and catheter complicati ons (three persons).

Conclusi on:
Even tho ugh continuo us applicati on of baclofen using pump systems is a safe method of tre atment of severe spasticity, it is necessary to be ar in mind possible complicati ons and adverse drug effects; these, however, tend to be of minor severity and can be successfully resolved, ide ally in speci alised centres.

Key words:
spasticity – intrathecal applicati on of baclofen – pump systems – complicati ons of tre atment with intrathecal baclophen

Zdroje

1. Shee an G. The pathophysi ology of spasticity. Eur J Ne urol 2002; 9(Suppl 1): 3– 9.

2. Kaňovský P. Patofyzi ologi e spasticity v dospělosti. In: Kaňovský P, Bareš M, Dufek J et al (eds). Spasticita, mechanismy, di agnostika a léčba. Praha: Maxdorf 2004: 83– 88.

3. Penn RD, Kro in JS. Intrathecal baclofen allevi ates spinal cord spasticity. Lancet 1984; 1(8385): 1078.

4. Avellino AM, Loeser JD. Intrathecal baclofen for tre atment of intractable spasticity of spine or brain eti ology. Ne uromodulati on 2000; 2: 75– 81.

5. Bovi atsis EJ, Ko uyi alis AT, Korfi as S, Sakas DE. Functi onal o utcome of intrathecal baclofen administrati on for severe spasticity. Clin Ne urol Ne urosurg 2005; 107(4): 289– 295.

6. Campbell WM, Ferrel A, McLa ughlin JF, Grant GA, Loeser JD, Gra ubert C et al. Long‑term safety and efficacy of contino us intrathecal baclofen. Dev Med Child Ne urol 2002; 44(10): 660– 665.

7. Ko ulo usakis A, Kuchta J. Intrathecal antispastic drug applicati on with implantable pumps: results of a 10 ye ars followup study. Acta Ne urochir Suppl 2007; 97(1): 181– 184.

8. Ochs G, Na umann C, Dimitrijevic M, Sindo u M. Intrathecal baclofen therapy for spinal origin spasticity: Spinal cord injury, spinal cord dise ase, and multiple sclerosis. Ne uromodulati on 1999; 2: 108– 119.

9. Ordi a JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuo us intrathecal baclofen infusi on by a programmable pump in 131 consecutive pati ents with severe spasticity of spinal origin. Ne uromodulati on 2002; 1: 16– 24.

10. Zahavi A, Geertzen JH, Middel B, Staal M, Ri etman JS. Long term effect (more than five ye ars) of intrathecal baclofen on impairment, disability and qu ality of life in pati ents with severe spasicity of spinal origin. J Ne urol Ne urosurg Psychi atry 2004; 75(11): 1553– 1557.

11. Ho udek M, Kala M, Pavlíček V. Míšní spasticita – nové léčebné možnosti. Praktický lékař 1996; 76: 110– 112.

12. Štětkářová I, Šro ubek J, Vrba I, Peregrin J, Havrdová E. Jednorázové intratékální podání baklofenu a následné zavedení pumpového systému v léčbě těžké spasticity u osob s roztro ušeno u sklerózo u. Cesk Slov Ne urol N 2007; 70/ 103 (2): 190– 195.

13. Štětkářová I, Vrba I. Intratekální podávání baklofenu v léčbě těžké spasticity. Bolest 2006; 9: 76– 82.

14. Ho udek M, Gabryš M. Implantace pumpy – technický popis (pumpa, programátor, katetry) a operační technika. In: Ho udek M et al (eds). Ne uromodulace. Praha: Grada Publishing 2007: 254– 260.

15. Follet KA, Burchi el K, Deer T, DuPen S, Prager J, Turner MS et al. Preventi on of intrathecal drug delivery catheterrelated complicati ons. Ne uromodulati on 2003; 6: 32– 41.

16. Follet KA, Bo ortz-Marx RL, Drake JM, DuPen S, Schneider SJ, Turner MS et al. Preventi on and Management of Intrathecal Drug Delivery and Spinal Cord Stimulati on System Infecti ons. Anesthesi ology 2004; 100(6): 1582– 1594.

17. Kamran S, Wright BD. Complicati ons of intrathecal drug delivery system. Ne uromodulati on 2001; 4(3): 111– 115.

18. Winkelmuller M, Winkelmuller W. Long term effect of continuo us opi o id tre atment in chronic pain of nonmalignant eti ology. J Ne urosurg 1996; 85(3): 458– 467.

19. Flückiger B, Knecht H, Grossmann S, Felleiter P. Device-related complicati ons of long‑term intrathecal drug therapy vi a implanted pumps. Spinal Cord 2008.

20. Saltu ari L, Kofler M, Schmutzhard E. Clinical symptomatology and management of a severe intrathecal baclofen intoxicati on. In: Lakke JPWF, Delhaas EM, Rutgers AWF (eds). Parenteral Drug Therapy in Spasticity and Parkinson’s Dise ase. Lancs: Parthenon Publishing 1992: 125– 129.

21. MullerSchwefe G, Penn RD. Physostigmine in the tre atment of intrathecal baclofen overdose. Report of three cases. J Ne urosurg 1989; 71(2): 273– 275.

22. Medtronic Inc. Indikace, stabilita léku a postupy v případě mimořádných událostí – Synchromed, Isomed. Informace pro lékaře a referenční příručka 2005.

23. Sallerin-Ca ute B, Lazorthes Y, Monsarrat B, Cros J, Bastide R. CSF baclofen levels after intrathecal administrati on in severe spasticity. Eur J Clin Pharmacol 1991; 40(4): 363– 365.24. Coffey RJ, Edgar TS, Francisco GE, Grazi ani V, Meythaler J, Ridgely PM et al. Abrupt withdrawal from intrathecal baclofen: recogniti on and management of a potenti ally life- thre atening syndrome. Arch Phys Med Rehabil; 2002; 83(6): 735– 741.

25. Čumlivski R, Redl G, Strobl W, Girsch W, Krebs A, Machowetz P. Farmakologická ne uromodulace spasticity intratekálně podávaným baklofenem u dětí. Bolest 2006; 9(2): 88– 98.

26. Erdine S, De Andrés J. Drug delivery systems. Pain Practise 2006; 6(1): 51– 57.

27. Dari o A, Scamoni C, Picano M, Fortini G, Cuffari S, Tomei G. The infecti on risk of intrathecal drug infusi on pumps after multiple refill procedures. Ne uromodulati on 2005; 8(1): 36– 39.

28. Wunderlich C., Krach LE. Gramnegative meningitis and infecti ons in individu als tre ated with intrathecal baclofen for spasticity: a retrospective study. Dev Med Child Ne urol 2006; 48(6): 450– 455.

29. Ho udek M, Gabryš M. Implantace pumpy technický popis (pumpa, programátor, katétry) a operační technika. In: Ho udek M et al (eds). Ne uromodulace. Praha: Grada Publishing 2007: 252– 260.

30. Ho udek M, Kala M. Komplikace implantabilních programovatelných infuzních pump, jejich prevence a možnosti řešení. In: Ho udek M et al (eds). Ne uromodulace. Praha: Grada Publishing 2007: 272– 277.

31. Krames ES, Chapple I. Reli ability a clinical utility of an implanted intraspinal catheter used in the tre atment of spasticity and pain. Ne uromodulati on 2000; 3: 7– 14.

32. Plassat R, Perro uin Verbe B, Menei P,Menegalli D, Mathé JF, Richard I. Tre atment of spasticity with intrathecal baclofen administrati on: long‑term follow‑up, revi ew of 40 pati ents. Spinal Cord 2004; 42(12): 686– 693.

33. Stokic DS, Yablon SA, Hayes A. Comparison of clinical and ne urophysi ologic responses to Intrathecal baclofen bolus administrati on in moderate- to- severe spasticity after acquired brain injury. Arch Physi ol Med Rehab 2005; 86(9): 1801– 1806.

34. Stokic DS, Yablon SA, Hayes A, Vesovic-Potic V, Olivi er J. Dose-response relati onship between the H-reflex and continuo us intrathecal baclofen administrati on for management of spasticity. Clin Ne urophysi ol 2006; 117(6): 1283– 1289.