- Original Article
- Open Access
Plain radiography in patients treated with intrathecal drug delivery using an implantable pump device
© The Author(s) 2017
- Received: 4 May 2017
- Accepted: 26 July 2017
- Published: 24 August 2017
Intrathecal drug administration using an implanted pump system is well established in intractable spasticity and pain. However, despite continuous advancements in manufacturing technology, adverse events related to the pump and catheter still occur. Most of them, such as migration, damage, disconnection and occlusion, are related to the spinal catheter. The aim of this overview is to update radiologists on how plain radiography of the implanted delivery system for intrathecal drug administration should be interpreted and to increase awareness for the need of urgent and timely multidisciplinary troubleshooting.
Plain radiographic images of patients treated with intrathecal drug administration using an implantable drug delivery system were analysed in a multidisciplinary setting at our (university) referral centre for complications in intrathecal drug administration.
Examples of catheter-related adverse events are described and a proposal is made for stepwise interpretation of standard plain radiographic images.
Plain radiological images are the mainstay for the diagnosis of catheter-related adverse events in intrathecal drug delivery. Radiologists play an important role in an early diagnosis. An awareness of abnormal radiological findings seems important to avoid a life-threatening withdrawal syndrome.
• Untimely cessation of intrathecal drug delivery can lead to a life-threatening withdrawal syndrome.
• Initially mild symptoms can lead to an exacerbation of a withdrawal syndrome.
• Most intrathecal catheter-related problems are visible on plain radiography.
• Common causes of catheter problems are migration, lacerations, occlusion and disconnection.
• Knowledge on implanted intrathecal catheters is crucial for interpretation of plain radiography.
- Diagnostic imaging
- Spinal infusions
- Implantable infusion pumps
- Adverse events
For over 30 years intrathecal drug delivery systems have been successfully applied in thousands of patients for the management of spasticity [1, 2] and dystonia (both intrathecal baclofen) , and for chronic pain (intrathecal analgesic drugs) [4, 5]. Compared with oral administration, infusion directly into the cerebrospinal fluid (CSF) has an extended treatment effect and with fewer unwanted side effects [1, 6]. There is general consensus that intrathecal therapy should be reserved for patients who have an insufficient response to more conservative therapies and/or for patients who experience serious side effects .
Despite generally favourable and safe outcomes [8, 9] and continuous advancements in manufacturing technology, pump and catheter-related adverse events still occur . Although the benefits usually outweigh the risks , even limited exposure to adverse events remains a problem. Early recognition of complications and their prompt management is needed.
Most of the drug delivery device-related adverse events are caused by intrathecal catheter failure [12–14]. Approximately 15–40% of patients experienced catheter complications [2, 15–18]. With the newly developed Ascenda catheter instead of the older silicone catheters, a tremendous reduction from 18 to 1.1% was reported by Motta and Antonello . The main reasons for this are migration, lacerations, occlusion and disconnection of the catheter, which cause a sudden cessation of intrathecal drug administration. Abrupt interruption of intrathecal baclofen delivery can present within several to 48 h with a spectrum of signs and symptoms. Then, the initially mild symptoms of exacerbation of spasticity, fever, excessive sweating and pruritus can escalate to a life-threatening multi-organ failure. Over time, hyperthermia develops with values up to 42° C , accompanied by nausea, respiratory distress, hypotension, tachycardia, hallucinations, delirium, disorientation, psychosis, sometimes with seizures, rhabdomyolysis with increased creatinine kinase levels resulting in disseminated intravascular coagulation and multi-organ failure [13, 21–29]. In rare cases, intrathecal baclofen withdrawal can even be fatal [30, 31]. The symptoms are probably related to the release of excitatory neurotransmitters that occurs when baclofen-mediated inhibition GABA-B effect is abruptly interrupted [32–34]. The heterogeneous symptoms occurring during withdrawal of intrathecal baclofen and of intrathecal opioid treatment may result in misdiagnosis, wrong referrals and (eventually) in a disastrous treatment delay. An additional problem is the referral of the patient in good time to a specialised centre, which is a requisite for successful treatment . Different imaging techniques, including plain radiography, fluoroscopy with contrast material injection via the access port of the pump, CT myelography, MRI and 111In-DTPA scintigraphy, are used to diagnose malfunction of the drug delivery system [14, 36–41]. Of all these imaging modalities, plain radiography is the most important, especially in an acute situation. Furthermore, a rigorous and adequate interpretation of the images by the radiologist is crucial to make a correct diagnosis and, if necessary, implement (urgent) interventions.
This overview aims to offer the radiologist a systematic approach for the evaluation of all parts of the intrathecal delivery system on plain radiography. This may help radiologists to identify causes of drug delivery failures in emergency and in chronic situations.
Below, we describe the most commonly used methods: (1) intrathecal drug delivery system, (2) intrathecal catheter and (3) surgical implantation technique.
Intrathecal drug delivery system
The implantable Synchromed II pump and the related intrathecal catheters have received the Conformité Européenne (CE) mark and are approved by the U.S. Food and Drug Administration (FDA) for treatment of pain and spasticity. During continuous intrathecal drug delivery, the prescribed medication is administered through an intrathecal catheter, connected with an implantable programmable pump system. The pump provides precise intrathecal drug delivery to patients with spasticity or chronic intractable pain. Via the refill septum, which is in the centre of the device (Fig. 1a), the reservoir is filled percutaneously. The gas below the reservoir exerts pressure which advances the drug into the inner tubing of the pump. The accompanying programmer device enables the delivery rate and mode to be programmed. A rotor system pushes the programmed dose with precision through the catheter access port via the catheter into the intrathecal space.
Over time, several catheter types for the implantable Synchromed II pump have been developed and are commercially available. Although two types of intrathecal catheters (the 8731SC, and the Ascenda) are currently available, older types are still in use. Determining the type of implanted catheter via plain radiography is important for correct interpretation.
Older catheters have a sutured pump-catheter connection and distinct differences in anchoring (this could even be absent), different catheter-catheter connection, different catheter ends, and the presence or absence of a mushroom-shaped titanium tip. Either a so-called ‘one’ piece catheter type with only a connection at the pump or a two-segment catheter are used.
Surgical implantation technique drug delivery system
Implantation is performed under local anaesthesia with intravenous sedation or general anaesthesia, With the patient in lateral decubitus position, a 3– to 4-cm dorsal midline incision is made at the planned implantation level up to the muscular fascia. On level L2-L3 or L1-L2 a silicone catheter is obliquely inserted into the intrathecal space, using a 15-G (8731SC catheter) or 16-G (Ascenda catheter) introduction (Tuohy) needle. The introduction needle is inserted 1–2 cm using a paramedian approach  to prevent catheter shearing and crushing by the frequent movements of the vertebral spinal process when a midline approach is applied. Under fluoroscopy the catheter is advanced to the mid-thoracic level [43–45]. Some physicians claim that positioning of the tip at the high thoracic, or even cervical position, gives a better result on the upper extremities; however, this has not yet been proved [46, 47]. At the abdominal site, a subcutaneous pocket is made in which the pump is placed and sutured using the outside suture loops of the pump. The pump catheter segment is connected suturelessly to the pump and tunnelled from the pump pocket to the dorsal incision, where it is connected to the spinal catheter part. The excess catheter length should be placed dorsal to the pump in the pocket.
Radiological examination after implantation of an intrathecal drug delivery system
Since the quality of the perioperative fluoroscopic images is insufficient for detailed information, routine postoperative plain radiography is performed after all of the surgical procedures and manipulations. For adequate interpretation, plain radiography of the pump and the entire implanted catheter in two directions is required .
Development of a stepwise interpretation schedule
A stepwise interpretation of the standard plain radiographic images has been developed (Appendix) to offer the radiologist a systematic approach for the evaluation of all parts of the intrathecal delivery system on plain radiography. This stepwise interpretation is based on expert opinion.
The normal and abnormal plain radiographic findings are described in a 14-step approach, a pump roller examination is also described.
Fourteen-step interpretation of standard plain radiographic images
- Step 1
Previous radiographs available?
- Step 2
Type of catheter used.
- Step 3
- Step 4
- Step 5
Excess pump catheter segment behind the pump
- Step 6
- Step 7
Catheter pump segment
- Step 8
- Step 9
Spinal segment of the catheter outside the spinal canal
- Step 10
- Step 11
Catheter insertion, midline or paramedian?
- Steps 12–13
Spinal intrathecal catheter segment
Due to the poor visibility of the Ascenda catheter, the thoracic or the cervical vertebral column catheter segment is inadequately imaged. This leads to lack of information on the position of the catheter.
- Step 14
Radio-opaque catheter tip
In the latest catheters, a titanium tip has been built into the end of the catheter. In these intrathecal catheters, on plain radiography this tip is recognised as a ball at the end of the catheter (Figs. 2, 3 and 6).
Special pump roller examination
If the rotor of the pump stalls, a two-tone emergency alarm will sound. After interrogation with the device programmer, the device display indicates a ‘Motor Stall’. When no motor stall is indicated and this is not derived from the pump logs, a roller study should be performed in case failure is suspected (Fig. 12). In this procedure, the pump is programmed in the continuous infusion mode, using a preset, without activation and with a priming bolus of 10 μl with a duration of 1 min. With fluoroscopy, the rotor is visualised, thereby reducing the aperture. A plain radiographic image is made and the preset bolus delivery is activated. After 2 min, a new plain radiographic image is made and the two images are compared. In a normal pump function, the rollers have moved approximately 60° from their original position. The extra radiopaque dot on one of the roller arms helps to visualise the roller movement (Fig. 12).
Although intrathecal drug administration using an implanted pump system has been employed for many years in therapy-resistant spasticity and intractable pain, knowledge on diagnostic imaging during adverse events remains limited.
The main reasons for this limited knowledge include (1) the diminished frequency of catheter-related treatment failures due to advancements in manufacturing and (2) the limited application of the treatment in different clinics. While plain radiography is the mainstay for the diagnosis of drug delivery device-related adverse events, radiologists play an important role in early diagnosis. An awareness of typical radiographic images in relation to intrathecal catheter failure is important to avoid a (sometimes life-threatening) withdrawal syndrome. The most frequent causes of drug delivery failure are migration, damage, disconnection and occlusion of the spinal catheter. In our opinion, applying the presented 14-step analysis and increasing the awareness of abnormal radiological findings will help physicians to avoid a life-threatening withdrawal syndrome.
A limitation of this proposal is that our approach has not yet been validated but is based on our expert opinion. Due to the present lack of high-quality evidence, we strongly believe that, as a first step in quality improvement, the current variation in radiological practice should be avoided. The stepwise approach, as proposed by our group, might be an effective first step towards raising the quality of care related to troubleshooting for intrathecal drug delivery with implanted systems.
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