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РЕКОНСТРУКТИВНАЯ И МИКРОСОСУДИСТАЯ ХИРУРГИЯ ■
НЕЙРОМОДУЛЯЦИЯ В ЛЕЧЕНИИ ХРОНИЧЕСКОЙ БОЛИ У ПАЦИЕНТА С СИНДРОМОМ ЭЛЕРСА-ДАНЛО И ИМПЛАНТИРОВАННЫМ ЭЛЕКТРОКАРДИОСТИМУЛЯТОРОМ
А.Е. Яковлев, М.В. Яковлева, С. Орлов
Отделение комплексного лечения болевого синдрома в Фокс Вэлли, Аплтон, Висконсин, США
Введение. Мы сообщаем об успешном случае лечения упорной боли у пациентки с синдромом Элерса-Данло и имплантированным электрокардиостимулятором (ЭКС). Интенсивная боль в поясничной области, связанная с постламинэктомическим синдромом, у женщины 56 лет была купирована методом периферической нейростимуляции.
Методы. 56-летней женщине с синдромом Элерса-Данло и некупируемой консервативным лечением болью в пояснице, развившейся вследствие постламинэктомического синдрома, была проведена успешная пробная периферическая нейростимуляция с использованием четырехконтактных подкожных электродов (Medtronic Inc, Minneapolis, MN), позиционированных в поясничной области. Ранее пациентке был имплантирован постоянный двухкамерный ЭКС (St.Jude, SJM, Inc, Plano, TX) в связи с синдромом слабости синусового узла и клинически значимыми эпизодами брадикардии (синкопальные состояния).
Результаты. Во время тестовой периферической нейростимуляции не отмечалось дисфункций в работе нейростимулятора и ЭКС. Пациентка отметила более чем 75% снижение интенсивности боли во время тестовой стимуляции. Временные электроды были удалены, и через 2 нед пациенке были имплантированы неподзаряжаемый генератор и электроды для постоянной нейростимуляции. Обсуждение. До недавнего времени пациентам с имплантированными ЭКС методика нейростимуляции считалась противопоказанной в связи с возможным нежелательным взаимодействием обоих устройств. Учитывая увеличение доли пожилых людей в популяции, все более актуальными становятся вопросы совместного использования методик нейромодуляции и кардиостимуляции, что требует дальнейшего изучения по мере накопления клинического опыта.
Заключение. Уместное использование постоянной нейростимуляции и электрокардиостимуляции является безопасной методикой. Ранее имплантированный ЭКС не лимитирует применение методов нейростимуляции в лечении хронических болевых синдромов, некурабель-ных традиционными способами.
Клин. и эксперимент. хир. Журн. им. акад. Б.В. Петровского. 2015. № 2. С. 83-87.
ДЛЯ КОРРЕСПОНДЕНЦИИ
Alexander Yakovlev, Comprehensive Pain Management of the Fox Valley, SC, 820 East Grant Street, Suite 335, Appleton, WI 54911, USA E-mail: [email protected]
Ключевые слова:
синдром Элерса-Данло,
хроническая боль,
нейростимуляция,
имплантированный
электрокардиостимулятор
(ЭКС), боль в спине,
периферическая
нейростимуляция,
постламинэктомический
синдром
Treating chronic pain using neurostimulation therapy in a patient with ehlers-danlos syndrome and implanted cardiovascular electronic device
A.E. Yakovlev, M.V. Yakovleva, S. Orlov
From Comprehensive Pain Management of the Fox Valley, Appleton, WI
Introduction. We report a case study of a patient with Ehlers-Danlos syndrome and previously implanted cardiovascular implantable electronic device (CIED) successfully treated with peripheral nerve field stimulation (PNFS) for intractable low back pain related to postlaminectomy syndrome (PLS).
Keywords:
EhLers—DanLos syndrome, chronic pain, neurostimuLation, cardiovascular implantable electronic devices, Low back pain, peripheral nerve field stimulation, postLaminectomy syndrome
Methods. An 56 year-oLd femaLe with EhLers-DanLos syndrome and history of refractory to conservative treatment intractabLe Low back pain reLated to PLS underwent an uneventfuL PNFS triaL with percutaneous pLacement of 4 temporary 4-eLectrode Leads (Medtronic Inc, MinneapoLis, MN) pLaced subcutaneousLy over the Lumbar area. The patient had a previousLy impLanted St. Jude (SJM, Inc, PLano, TX) duaL chamber permanent pacemaker (PPM) pLaced for sick sinus syndrome. ResuLts. During the PNFS triaL, there were no signs of interference between the patient's PPM and the externaL neurostimuLator (ENS). The patient reported greater than 75% improvement in Low back pain during the two day PNFS triaL. The temporary Leads were removed and 2 weeks Later the patient was impLanted with permanent Leads and non-rechargeabLe generator. She reported sustained pain reLief tweLve months after impLantation.
Discussion. PreviousLy, treatment with neurostimuLators was considered generaLLy contraindicated in patients with cardiovascuLar impLantabLe eLectronic devices (CIEDs) because of concerns regarding potentiaL device interactions. As use of neurostimuLation therapies increases in an aging popuLation wideLy treated with CIEDs, feasibility and safety of simuLataneous use of these therapies has warranted further attention.
Conclusion. Concomitant neurostimuLation therapy and PPM is safe. Preexisting PPM is not a generaL contraindication for neurostimuLation therapy. Patients with a PPM and chronic intractabLe Low back pain shouLd not be excLuded from consideration of treatment with neurostimuLation therapy.
Clin. Experiment. Surg. Petrovsky J. 2015. N 2. Р. 83-87.
Treatment of chronic conditions using functional neurosurgical therapies is a rapidly expanding field. Neurostimulation is a widely accepted therapy for treating chronic pain with spinal cord stimulation (SCS) and peripheral nerve field stimulation (PNFS), for treating movement disorders such as Parkinsons Disease (PD) with deep brain stimulation (DBS), for treating gastric emptying disorders with vagus nerve stimulation, and for treating urinary dysfunction using sacral nerve stimulation (SNS). Previously, treatment with neurostimulators was considered generally contraindicated in patients with cardiovascular implantable electronic devices (CIEDs) because of concerns regarding potential device interactions [1]. These interactions include potential interference between devices such as inappropriate shock delivery via implantable cardiac defibrillator (ICD), permanent pacemaker (PPM) dysfunction, or reset of neurostimulator or implanted pulse generator (IPG) following shock delivery by an ICD [2].
As use of neurostimulation therapies increases in an aging population widely treated with CIEDs, feasibility and safety of simultaneous use of these therapies has warranted further attention. We report a case study of a patient with a previously implanted CIED successfully treated with PNFS for intractable low back pain related to postlaminectomy syndrome (PLS).
Postlaminectomy syndrome (PLS) refers to chronic back and/or leg pain which occurs in patients after spinal operations. Of the 200,000 patients in the United States who undergo spine surgery each year, 20% to 40% experience persistent or recurrent pain [3] which may be refractory to conservative therapies. Peripheral nerve field stimulation (PNFS) has
been used to treat a variety of neuropathies [4], including ileoinguinal [5], occipital [6-9], postherpetic [10], intercostals [11], for treatment of trigeminal postherpetic neuralgia, trigeminal posttraumatic neuropathic pain [12-15], atypical facial pain [16], chronic pelvic pain [17], and hip pain after total hip arthroplasty or greater trochanteric bursectomy [18] with excellent relief of pain and reduced need for oral pain medications. Recent reports describing treatment of low back pain by using stimulation through the leads placed subcutaneously in areas with localized pain [19-22] demonstrated good efficacy, simplicity and low morbidity.
Methods
An 56 year-old female with a history of intractable low back pain experienced poor pain control utilizing conservative therapies. He had a long history of low back pain related to lumbar spinal stenosis and 7 years prior to presenting for treatment in our pain clinic had undergone lumbar decompression and spinal fusion which actually worsened his pain. She had trialed over-the-counter NSAIDS, acetaminophen with minimal improvement in the pain level and numerous opioids, tramadol, neuromodulators, muscle relaxants, and antidepressants commonly used to treat chronic pain but did not tolerate them due to central nervous system sedating side effects. The patient had no lower extremity pain but reported 100% of her pain in the low back exacerbated by rising from bed in the morning, standing and walking. She reported no pain when seated or lying down. The patient had undergone no interventional procedures prior
to surgical intervention. After beginning treatment in our pain clinic she underwent a series of 3 caudal epidural injections which gave her no improvement in the pain. The patient was diagnosed with Ehlers-Danlos syndrome and had a previously implanted St. Jude (SJM, Inc, Plano, TX) dual chamber permanent pacemaker (PPM) because of sick sinus syndrome. Prior to offering the patient PNFS trial to cover the area of pain in his lumbar spine, we contacted St. Jude Medical, Inc for information regarding safety and recommendations regarding use of neurostimulation therapy with PPM. It was recommended that the neurostimulator be tested for possible interactions such as inhibition of pacing, asynchronous pacing or noise reversion after implantation by programming the neurostimulator to its highest output and the pacemaker to its most sensitive setting and monitoring the patient on an EKG to determine of the neurostimulator was causing over sensing that may interfere with the function of the PPM [23]. The risks, benefits and alternatives of PNFS trial to cover the area of pain over the lumbar spine were discussed with the patient, including the potential effects of neurostimulation causing interference with his PPM and he decided to proceed.
Following psychological evaluation with clearance for elective medical device implantation, the patient underwent an uneventful PNFS trial with percutaneous placement of 4 temporary 4-electrode Quad-Plus leads (Medtronic Inc, Minneapolis, MN) placed subcutaneously over the lumbar area. A St. Jude, Inc. cardiac pacemaker clinician was present during the the PNFS trial. Because of the large area of midline low back pain, we did not find it feasible to cover the area of the pain with only two vertically placed 8-electrode leads. Four 4-electrode leads spreading vertically superiorly and inferiorly were placed with the goal to cover maximal extent of painful region with the use of one generator. Generators like a non- rechargeable RestorePrime (Medtronic Inc., Minneapolis, MN) or rechargeable generators Re-storeUltra (Medtronic Inc., Minneapolis, MN) offer the ability to use up to four Quad-Plus leads or two Octad leads and the ability to program each lead independently with amplitude up to 10.5 volts regardless of the number of activated electrodes.
After local infiltration of 1% lidocaine, the leads were inserted through 15 gauge Touhy needles. The leads were placed vertically, parallel and lateral to postoperative scar in the area of maximum pain. Two leads were inserted superiorly and inferiorly in the each paraspinal area in the lumbar region. All four leads were attached to connecting leads then to temporary extension cable and to a temporary external stimulator. During the procedure the patient reported 75% coverage of painful areas with the settings as follows: pulse width 450 psec, Pulse rate
Fig. 1. The incisions made in paraspinal areas of lumbar region for placement of the leads during permanent implantation
Fig. 2. Percutaneous placement of four 4-electrode Quad-Plus Leads (Medtronic Inc., Minneapolis, MN) subcutaneously during the surgery
Fig. 3. Four 15 gauge Touhy needles placed subdermally in the paraspinal area of the lumbar region parallel to postoperative scar during permanent implantation
60 Hertz, and amplitude 5 Volts. During intraoperative testing the amplitude was increased to the maximum intensity of 10.5 Volts while the patient was being monitored on EKG and no PMM interference was noted. During the 3 day PNFS trial the patient reported greater than 75% improvement in pain. Temporary leads were removed and 2 weeks later the patient underwent implantation with permanent
Fig. 4. The pocket for the generator made in the right supragluteal area with attached to the fascia PrimeADVANCED non-rechargeable (Medtronic Inc., Minneapolis, MN) generator
leads through small parallel to midline incisions made in the paraspinal areas of the lumbar region (Fig. 1). The leads were passed through slightly bent 15 Gauge Tuohy needles to follow the curvature in lumbar area (Fig. 2). Two 4-electrode leads were inserted subdermally in superior and inferior direction through each incision vertically and parallel to each other. Total four 4-electrode leads were left in place (Fig. 3). During intraoperative testing the patient again reported 75% coverage of painful areas. Recommended intraoperative testing was again repeated, with the amplitude increased to the maximum intensity of 10.5 Volts while the patient was being monitored on EKG. Again, no PMM interference was noted. The leads were anchored in the each of two wounds to fibroaponeurotic tissue with 2-0 nonabsorbable suture of braided polyester (Ethibond) and Titan Anchors (Medtronic Inc., Minneapolis, MN). The leads were attached to connecting leads which then were tunneled to the left or right supragluteal areas where the subcutaneous pocket was created for the generator (Fig. 4). Leads were then affixed to a non-rechargeable generators PrimeADVANCED (Medtronic Inc., Minneapolis, MN). The procedure for permanent implantation was performed with conscious sedation and local anesthesia. The post-operative course was uneventful. The stimulator was programmed using a guarded electrode configuration with a pulse width of 450 |jsec, pulse rate of 60 Hertz and amplitude use ranging from 2.1 to 5.7 Volts.
Electrode polarities were set as follow: First lead: 0(+) 1(-) 2(+) 3(-) Second lead: 4(+) 5(-) 6(+) 7(-) Third lead: 8(+) 9(-) 10(+) 11(-) Fourth lead : 12(+) 13(-) 14(+) 15(-)
Results
The patient recovered from implant procedure without complications. After implantation she re-
ported excessive stimulation which was described as "shocking" at the distal electrode of the right lower lead. Following reprogramming of the electrodes the distal electrode of the right lower lead was deactivated and the patient reported complete resolution of uncomfortable sensation. She stated greater than 75% improvement in pain level and satisfaction with the degree of pain relief she had achieved.
At twelve month follow-up visit the patient reported continued significant pain relief (>75% reduction in VAS) with permanent stimulator. Stimulator parameters were in the same range like during PNFS trial. The patient continued off pain medications and also reported other positive outcomes including the ability to return to social and recreational activities. There was no evidence of interference between the neurostimulator and PPM on EKG during trial or implant. There was no evidence of interference between the neurostimulator and PPM during subsequently interrogations of the neurostimulator and PPM.
Discussion
The treatment of chronic low back pain in a patient with PLS is a challenge for patients and as well as for physicians treating them. Comorbid conditions and patients' advanced age may further complicate or limit treatment options. Thought previously to be contrain-dicated for patients with CIEDs, neurostimulation therapies are now understood to be a feasible treatment option. It is especially encouraging that neurostimulation may be a treatment option for patients who in the past did not tolerate the side effects of or realize satisfactory relief using medications commonly used to treat chronic pain such as opioids or neuromodulators or other interventional procedures. The neuro-modulating effects of electrical stimulation are based on the tenets of the "gate-control theory" of pain proposed by Melzack and Wall in 1965 [24]. Based on this theory, it is hypothesized that PNFS "closes the gate" to pain transmission by activating large-diameter afferent fibers via application of an electric field. PNFS may also alter local blood flow, cause release of endorphins, affect neurotransmitters and axonal conduction, and may block cell membrane depolarization [21]. The mechanism of action of PNFS and neuromodulation in general continues to be investigated as there may be a multitude of ways in which neuromodulation affects pain transmission.
PNFS provides a safe, effective, and convenient treatment option for patients with PLS suffering from chronic intractable low back pain. PNFS has many advantages over many conservative treatments as well as more invasive techniques. There is a high rate of success with permanent implant due to the fact that a trial is performed during which the patient evaluates the efficacy of the device. For patients with PPM,
introperative testing during trial lead placement and permanents neurostimulator implant including monitoring for interference between devices ensures feasibility of the therapy for patients with PPM.
Conclusion
We present a case report of a single patient with Ehlers-Danlos syndrome, intractable low back pain
due to PLS and PPM successfully treated with PNFS. The case represents the feasibility of simultaneous use of a neurostimulator in the presence of an existing PPM. For the patients with the presence of a preexisting PPM, neurostimulation therapy should not be considered as a general contraindication. Future prospective studies with larger patient populations are important to further establish feasibility and to explore any possible interactions.
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