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Titolo:
A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus
Autore:
Pollack, IF; Albright, AL; Adelson, PD;
Indirizzi:
Childrens Hosp Pittsburgh, Dept Neurosurg, Pittsburgh, PA 15213 USA Childrens Hosp Pittsburgh Pittsburgh PA USA 15213 ittsburgh, PA 15213 USA
Titolo Testata:
NEUROSURGERY
fascicolo: 6, volume: 45, anno: 1999,
pagine: 1399 - 1408
SICI:
0148-396X(199912)45:6<1399:ARCSOA>2.0.ZU;2-F
Fonte:
ISI
Lingua:
ENG
Soggetto:
NORMAL-PRESSURE HYDROCEPHALUS; SLIT-VENTRICLE SYNDROME; EX-VIVO EXAMINATION; VENTRICULOPERITONEAL SHUNT; PEDIATRIC HYDROCEPHALUS; SUBDURAL HEMATOMAS; ADJUSTABLE VALVES; REDUCING DEVICES; ANTI-SIPHON; FLUID;
Keywords:
cerebrospinal fluid; hydrocephalus; outcome; programmable; randomized study; shunt;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
53
Recensione:
Indirizzi per estratti:
Indirizzo: Pollack, IF Childrens Hosp Pittsburgh, Dept Neurosurg, 3705 5th Ave, Pittsburgh, PA 15213 USA Childrens Hosp Pittsburgh 3705 5th Ave Pittsburgh PA USA 15213
Citazione:
I.F. Pollack et al., "A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus", NEUROSURGER, 45(6), 1999, pp. 1399-1408

Abstract

OBJECTIVE: A multicenter prospective randomized controlled study was performed to assess the safety and efficacy of a Codman Hakim programmable shuntvalve (Codman/Johnson & Johnson, Raynham, MA) versus a conventional valve system of the surgeon's choice for the treatment of patients with hydrocephalus. METHODS: Enrollment was stratified on the basis of whether the patient wasundergoing initial shunt insertion or revision of an existing valve systemat study entry. Study end points were: 1) valve explantation, and 2) shuntfailure (surgical intervention for any component of the shunt). A total of377 patients were enrolled onto the study, with 235 undergoing first shuntinsertion (119 experimental, 116 control) and 142 undergoing revisions (75experimental, 67 control). RESULTS: During a follow-up interval of 104 weeks after the first implantation on-study, explantation of the valve was required in 62 (32%) of 194 experimental valves, compared with 71 (39%) of 183 control valves. Two-year survival rates of the original shunt without revision of any component were 52% (62 of 119) and 50% (58 of 116) in experimental and control patients, respectively, who underwent initial shunt insertion, and 43% (32 of 75) and 43% (29 of 67) in experimental and control patients, respectively, who underwent replacement of an existing valve. No statistically significant difference was observed between experimental and control patients in the survivalof either the valve or the overall shunt system. Control of hydrocephalus as assessed symptomatically and by imaging was comparable in the two treatment groups. Although problems related to inability to achieve the desired pressure setting were reported in 22 experimental valves, in all but four instances no additional programming was attempted because the patients were functioning well clinically. The most common reasons cited for valve explantation and shunt revision were infection (9.8% frequency in the overall cohort) and proximal shunt malfunction, which occurred with comparable frequency in the experimental and control groups. CONCLUSION: Safety and efficacy of the Codman Hakim programmable shunt valve is comparable to conventional valves in the overall population of patients with hydrocephalus. However, the current study was not designed to assess the efficacy of programmable versus conventional valves in the managementof individual hydrocephalus problems, and it had insufficient statistical power to support such comparisons. This study provides a rationale for examining whether the theoretical advantages of a programmable valve for managing challenging hydrocephalus problems can translate into meaningful improvements in shunt and valve survival.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 30/03/20 alle ore 19:56:01