Approvato dalla FDA nel 2011, un neurostimolatore Anti-Tracheo, il NeuRx DPS
In Italia ovviamente nessuno ne parla, noi siamo i primi, che a questo punto non esitiamo a richiamare concretamente all’attenzione tutti coloro RESPONSABILI in questo ambito, chiedendo possibilità di predisporre anche nel nostro paese di tali benefici.
Infatti come promesso abbiamo subito chiamato in causa il Nemo che gentilmente ci ha fornito la seguente risposta :
In realtà è un argomento che da un po’ se ne discute per comprenderne la reale utilità.
Di recente hanno pubblicato l’analisi dei dati dei pazienti a cui è stato applicato il pacing diaframmatico (di seguito l’abstract). Lo studio ha dimostrato che i pazienti a cui era stato impiantato hanno mostrato una sopravvivenza significativamente inferiore rispetto a quella dei pazienti seguiti come di consueto, dimostrando quindi che purtroppo non è utile ma addirittura che accelera la malattia.
1. Lancet Neurol. 2015 Sep;14(9):883-92. doi: 10.1016/S1474-4422(15)00152-0. Epub
2015 Jul 30.
Safety and efficacy of diaphragm pacing in patients with respiratory
insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre,
open-label, randomised controlled trial.
DiPALS Writing Committee; DiPALS Study Group Collaborators.
Comment in
Lancet Neurol. 2015 Sep;14(9):868-9.
BACKGROUND: Non-invasive ventilation is part of the standard of care for
treatment of respiratory failure in patients with amyotrophic lateral sclerosis
(ALS). The NeuRx RA/4 Diaphragm Pacing System has received Humanitarian Device
Exemption approval from the US Food and Drug Administration for treatment of
respiratory failure in patients with ALS. We aimed to establish the safety and
efficacy of diaphragm pacing with this system in patients with respiratory muscle
weakness due to ALS.
METHODS: We undertook a multicentre, open-label, randomised controlled trial at
seven specialist ALS and respiratory centres in the UK. Eligible participants
were aged 18 years or older with laboratory supported probable, clinically
probable, or clinically definite ALS; stable riluzole treatment for at least 30
days; and respiratory insufficiency. We randomly assigned participants (1:1), via
a centralised web-based randomisation system with minimisation that balanced
patients for age, sex, forced vital capacity, and bulbar function, to receive
either non-invasive ventilation plus pacing with the NeuRx RA/4 Diaphragm Pacing
System or non-invasive ventilation alone. Patients, carers, and outcome assessors
were not masked to treatment allocation. The primary outcome was overall
survival, defined as the time from randomisation to death from any cause.
Analysis was by intention to treat. This trial is registered, ISRCTN number
53817913.
FINDINGS: Between Dec 5, 2011, and Dec 18, 2013, we randomly assigned 74
participants to receive either non-invasive ventilation alone (n=37) or
non-invasive ventilation plus diaphragm pacing (n=37). On Dec 18, 2013, the Data
Monitoring and Ethics Committee (DMEC) recommended suspension of recruitment on
the basis of overall survival figures. Randomly assigned participants continued
as per the study protocol until June 23, 2014, when the DMEC advised
discontinuation of pacing in all patients. Follow-up assessments continued until
the planned end of the study in December, 2014. Survival was shorter in the
non-invasive ventilation plus pacing group than in the non-invasive ventilation
alone group (median 11·0 months [95% CI 8·3-13·6] vs 22·5 months [13·6-not
reached]; adjusted hazard ratio 2·27, 95% CI 1·22-4·25; p=0·009). 28 (76%)
patients died in the pacing group and 19 (51%) patients died in the non-invasive
ventilation alone group. We recorded 162 adverse events (5·9 events per
person-year) in the pacing group, of which 46 events were serious, compared with
81 events (2·5 events per person-year) in the non-invasive ventilation alone
group, of which 31 events were serious.
INTERPRETATION: Addition of diaphragm pacing to standard care with non-invasive
ventilation was associated with decreased survival in patients with ALS. Our
results suggest that diaphragmatic pacing should not be used as a routine
treatment for patients with ALS in respiratory failure.
FUNDING: The National Institute for Health Research Health Technology Assessment
Programme; the Motor Neurone Disease Association of England, Wales, and Northern
Ireland.
Copyright © 2015 DiPALS Study Group Collaborators. Open Access article
distributed under the terms of CC-BY-NC-ND 4.0. Published by Elsevier Ltd.. All
rights reserved.
PMID: 26234554 [PubMed - in process]
