Case report
Intrathecal baclofen pump exchange in multiple sclerosis. Factors affecting baclofen efficacy and dose adjustement. A case report
Recambio de bomba intratecal en esclerosis múltiple. Factores que interfieren en la eficacia y ajuste de dosis de baclofeno. A propósito de un caso
P. Lloreda Herradón
, V. Blázquez Calvo, M. Miyagi Yonamine, E. Alonso Rodríguez
Corresponding author
Hospital Severo Ochoa, Leganés, Madrid, Spain
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A case report" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "153" "paginaFinal" => "155" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "P. Lloreda Herradón, V. Blázquez Calvo, M. Miyagi Yonamine, E. Alonso Rodríguez" "autores" => array:4 [ 0 => array:4 [ "nombre" => "P." "apellidos" => "Lloreda Herradón" "email" => array:1 [ 0 => "patrihsvo@yahoo.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "V." "apellidos" => "Blázquez Calvo" ] 2 => array:2 [ "nombre" => "M." "apellidos" => "Miyagi Yonamine" ] 3 => array:2 [ "nombre" => "E." "apellidos" => "Alonso Rodríguez" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Hospital Severo Ochoa, Leganés, Madrid, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Recambio de bomba intratecal en esclerosis múltiple. Factores que interfieren en la eficacia y ajuste de dosis de baclofeno. A propósito de un caso" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1102 "Ancho" => 900 "Tamanyo" => 64563 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0035" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Lateral X-ray. View of catheter entry at L3 and retrograde route through the intrathecal canal to L5.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Multiple sclerosis is a chronic, autoimmune, inflammatory disease of unknown origin that is characterised by the development of demyelinating lesions and axonal damage in the central nervous system.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">It is one of the main causes of non-traumatic neurological disability in young adults, mainly women, and affects between 2.3 and 2.5 million people worldwide.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Symptoms are highly heterogeneous, ranging from mild neurological manifestations with flare-ups to rapid progression with disabling spasticity.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">It is diagnosed on the basis of symptoms and evidence of demyelinating lesions in the central nervous system in magnetic resonance imaging studies.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Treatment consists of drugs that slow the accumulation of lesions, control flare-ups and reduce symptoms, combined with rehabilitation. Prompt diagnosis and treatment is recommended in order to prevent progression of disability.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Patients with greater disability and great spasticity require more invasive treatment. One such therapy involves the implantation of intrathecal baclofen pumps in chronic pain units, a procedure which is not without complications.</p><p id="par0035" class="elsevierStylePara elsevierViewall">We present a case report.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Case report</span><p id="par0040" class="elsevierStylePara elsevierViewall">We report the case of a 42-year-old woman diagnosed with secondary progressive multiple sclerosis since 1993, with severe spastic tetraparesis (she controls an electric chair with her chin).</p><p id="par0045" class="elsevierStylePara elsevierViewall">She was under treatment in the pain unit of her local hospital, where she was implanted with a programmable intrathecal pump (Synchromed II Medtronic®) for baclofen infusion in 2006. In 2012, she was referred to our unit due to a change of address.</p><p id="par0050" class="elsevierStylePara elsevierViewall">In follow-ups, baclofen doses were kept between 260 and 300 μg per day (concentration of 1500 μg/mL) to make personal hygiene and postural changes easier.</p><p id="par0055" class="elsevierStylePara elsevierViewall">In December 2018, she went to the emergency room due to increased spasticity, fasciculations and inability to urinate spontaneously. She was examined by a neurologist and by our pain unit — the intrathecal pump was found to be working correctly and the batteries had 10 months left of life. The baclofen dose was increased and she was hospitalized under observation. Baclofen was increased to 550 μg/day, and symptoms improved. Correct positioning of the tip of the retrograde catheter in L5 with no granuloma formation was confirmed.</p><p id="par0060" class="elsevierStylePara elsevierViewall">The case was discussed in a clinical meeting and with the patient and, after signing the informed consent, we decided to replace the catheter and intrathecal pump. The procedure was scheduled for January 2019.</p><p id="par0065" class="elsevierStylePara elsevierViewall">Under general anaesthesia, and with antibiotic prophylaxis, the patient was placed in the right lateral decubitus position, the catheter and the pump were removed without incident, and a new purged catheter (entry at L4 pedicle) and a new pump (Synchromed II Medtronic®) were placed in the same subcutaneous plane (left hemiabdomen). Baclofen was down-dosed to 350 μg/day, with the catheter tip in T7, and the patient was admitted to the postsurgical care unit.</p><p id="par0070" class="elsevierStylePara elsevierViewall">In the following hours, she began to present generalized sedation and hypotonia, although haemodynamic and respiratory variables remained stable. Perfusion was suspended, and the catheter was checked to ensure it had not moved and that the pump was filling correctly. The patient improved within 24 h, so perfusion was restarted at 70 μg/day. At 48 h she was discharged home, with telephone and outpatient follow-up.</p><p id="par0075" class="elsevierStylePara elsevierViewall">In the following weeks she required gradual, continuous updosing to 230 μg/day.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Discussion</span><p id="par0080" class="elsevierStylePara elsevierViewall">Baclofen (β-[4-chlorophenyl]-GABA) is an agonist at the β subunit of γ-aminobutyric acid on mono- and polysynaptic neurons in the spinal cord and brain. It reduces the release of excitatory neurotransmitters in presynaptic neurons and stimulates inhibitory neuronal signals in postsynaptic neurons, resulting in relief of spasticity.</p><p id="par0085" class="elsevierStylePara elsevierViewall">It was approved by the Food and Drug Administration in 1992 for spinal spasticity and in 1996 for spasticity of central origin. The administration route of choice is oral; however, given its low bioavailability some patients present poor response or poor oral tolerance after up-dosing (nausea, weakness, vertigo, etc.). In these cases, administration is switched to the intrathecal route, which has an effector site concentration 100 times greater than oral administration.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Intrathecal baclofen has a half-life of 6 h and is usually administered continuously via an intrathecal pump.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0090" class="elsevierStylePara elsevierViewall">The intrathecal dose should be adjusted slowly and progressively to control side effects.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0095" class="elsevierStylePara elsevierViewall">Withdrawal syndrome<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> produces potentially dangerous symptoms, such as respiratory dysfunction and hypermetabolic state, with rhabdomyolysis, hypertension, hyperthermia, and seizures. Tolerance to baclofen is observed in 15%–20% of patients in the first 12 months after implantation. Overdose causes hypothermia, respiratory and cardiac depression.</p><p id="par0100" class="elsevierStylePara elsevierViewall">Other factors can influence effectiveness, such as the infusion mode (continuous mode with or without boluses), the location of the catheter (C3-T2 for upper limb spasticity, T10 for lower limbs and T6 for generalized), infusion rate, concentration (not recommended above 4000 μg/mL due to risk of precipitation and granuloma) and hypobaricity of baclofen.</p><p id="par0105" class="elsevierStylePara elsevierViewall">Aside from the side effects associated with baclofen itself, implantation of the intrathecal pump has its own complications (seroma, haematoma, infection, migration and rupture of the catheter, granuloma of the catheter tip).</p><p id="par0110" class="elsevierStylePara elsevierViewall">Nevertheless, several studies have shown that intrathecal pump implantation is safe, and that baclofen improves the quality of life of patients with severe spasticity due to multiple sclerosis or other diseases with similar clinical symptoms, such as infantile paralysis (<a class="elsevierStyleCrossRefs" href="#fig0005">Figs. 1 and 2</a>).<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,8</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Conclusion</span><p id="par0115" class="elsevierStylePara elsevierViewall">The use of intrathecal baclofen infusion is an effective and safe alternative<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> for patients with refractory and severe spasticity, and can improve their quality of life (personal hygiene, moving around, pain). However, it must be implanted in a pain unit in which staff are trained in the use of invasive therapies and are familiar with the indications, pharmacology and possible risks of both pump implantation and baclofen administration. Treatment should be individualized, and patients must undergo regular follow-ups.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Conflict of interests</span><p id="par0120" class="elsevierStylePara elsevierViewall">The authors have no conflict of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:10 [ 0 => array:3 [ "identificador" => "xres1491449" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1354129" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1491448" "titulo" => "Resumen" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1354130" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Case report" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Discussion" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Conclusion" ] 8 => array:2 [ "identificador" => "sec0025" "titulo" => "Conflict of interests" ] 9 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2019-10-24" "fechaAceptado" => "2020-02-04" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1354129" "palabras" => array:5 [ 0 => "Spasticity" 1 => "Multiple sclerosis" 2 => "Baclofen" 3 => "Intrathecal pump" 4 => "Complications" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1354130" "palabras" => array:5 [ 0 => "Espasticidad" 1 => "Esclerosis múltiple" 2 => "Baclofeno" 3 => "Bomba intratecal" 4 => "Complicaciones" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Multiple sclerosis is a neurological disease that presents with various symptoms; in some cases it is progressive and highly disabling, requiring invasive techniques to treat pain and spasticity. The use of intrathecal baclofen infusions is an effective and safe alternative for patients with severe and refractory spasticity. The therapy can improve quality of life, but must be performed in a pain unit by medical staff trained in the technique, its indications, pharmacology, and the potential risks of both the implant and the drug. The treatment can be individualized and patients must be followed up periodically.</p></span>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">La esclerosis múltiple es una enfermedad neurológica con clínica variada, que en algunos casos es progresiva y muy invalidante, requiriendo tratamientos invasivos para el dolor y la espasticidad. El uso de perfusiones de baclofeno intratecal es una alternativa eficaz y segura para pacientes con espasticidad refractaria y severa, y logra mejorar la calidad de vida, pero es preciso disponer de una unidad del dolor con personal entrenado para poder realizar estas terapias invasivas y conocer las indicaciones, farmacología y posibles riesgos tanto del implante como del uso del baclofeno. Se tiene que individualizar el tratamiento y realizar seguimientos periódicos.</p></span>" ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Lloreda Herradón P, Blázquez Calvo V, Miyagi Yonamine M, Alonso Rodríguez E. Recambio de bomba intratecal en esclerosis múltiple. Factores que interfieren en la eficacia y ajuste de dosis de baclofeno. A propósito de un caso. Rev Esp Anestesiol Reanim. 2021;68:153–155.</p>" ] ] "multimedia" => array:2 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1102 "Ancho" => 900 "Tamanyo" => 64563 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0035" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Lateral X-ray. View of catheter entry at L3 and retrograde route through the intrathecal canal to L5.</p>" ] ] 1 => array:8 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1286 "Ancho" => 900 "Tamanyo" => 109493 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0040" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">AP X-ray. Intrathecal pump shown in the lower right hemiabdomen and the catheter route from the L3 pedicle, with a more radiopaque distal tip at the level of L5.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:9 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Corrigendum to “Multiple sclerosis: new insights and trends”" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "M. 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