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Critical Failure of a Percutaneous Discectomy Probe Requiring Surgical Removal During Disc Decompression
Critical Failure of a Percutaneous Discectomy Probe Requiring Surgical Removal During Disc Decompression Richard Domsky, M.D., Michael E. Goldberg, M.D., Robert A. Hirsh, M.D., Denise Scaringe, M.D., and Marc C. Torjman, Ph.D. Objective: We report a complication while performing a percutaneous disc decompression at the L4-L5 level using a Dekompressor Percutaneous Discectomy Probe. Case Report: A 54-year-old male was referred to the pain clinic for possible percutaneous disc decompression. For the procedure the Dekompressor unit was inserted over the stylette and a percutaneous disc decompression was performed for 1 to 2 minutes using the channeling technique. Approximately ¾ mL of disc nucleus was successfully removed. Upon withdrawal of the Dekompressor unit, it was noted that the probe was no longer connected to the device handle. Fluoroscopic imaging showed that approximately 4 inches of the probe remained in the patient and that the auger’s distal end was still lodged in the disc. An incision was made, and the auger was successfully removed by a neurosurgeon. Conclusions: The patient had an uneventful recovery. Manipulation of the auger should be performed in a linear motion as best as possible and under fluoroscopic guidance. Reg Anesth Pain Med 2006;31:177-179. Key Words: Percutaneous discectomy, Dekompressor, Disc herniation, Probe failure, Chronic pain, Minimally invasive surgery, Fluoroscopic guidance.
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atients suffering from chronic low back and leg pain with radicular components because of contained disc herniation, and who have failed conservative therapies, can now be treated with a minimally invasive surgical tool before considering major back surgery.1-3 The probe (Dekompressor Percutaneous Discectomy Probe; Stryker Instruments, Kalamazoo, MI) was designed to aspirate disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine. The procedure is performed under fluoroscopic guidance, requiring only local anesthesia for insertion of the probe. The entire surgical device consists of a battery-operated disposable hand piece connected to a 6-inch long helical percutaneous discectomy probe (auger). The 1.5-mm (17-G) outer-diameter introducer cannula and 1.0-mm (19-G) probe insert provide access to the
From the Department of Anesthesiology, Cooper University Hospital, Robert Wood Johnson Medical School, UMDNJ, Camden, NJ. Accepted for publication October 4, 2005. Reprint requests: Richard Domsky, M.D., Department of Anesthesiology, One Cooper Plaza Suite 298 Kelemen Building, Camden, NJ 08103. E-mail: [email protected] © 2006 by the American Society of Regional Anesthesia and Pain Medicine. 1098-7339/06/3102-0013$32.00/0 doi:10.1016/j.rapm.2005.10.011
disc space while serving as a channel for tissue removal. When activated, the auger rotates and removes nucleus pulposus through the cannula using Archimede’s pump principle. There have been no reports in the literature on the occurrence of a complication from a clean break of the instrument probe requiring its surgical removal from the patient’s disc. We report on such a complication while performing a percutaneous disc decompression at the L4-L5 level using this instrument.
Case Report A 54-year-old man weighing 99 kg and 180 cm tall was referred to the pain clinic for possible percutaneous disc decompression. The patient’s injury originated from a fall resulting in chronic low back pain for the next 8 months, at which time he was seen in the Cooper University Hospital pain clinic. His pain was described as severe and radiating across the lower back, down to the right buttock and thigh. The patient was treated with physical therapy as well as epidural injections that only provided short-term pain relief. A neurologic examination revealed a husky individual with nonantalgic gait who was able to walk on his toes and heels but with limited back mo-
Regional Anesthesia and Pain Medicine, Vol 31, No 2 (March–April), 2006: pp 177–179
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Regional Anesthesia and Pain Medicine Vol. 31 No. 2 March–April 2006
tion and diffuse lower-back tenderness. He had no focal deficits in strength, sensation, or reflexes in the lower extremities but showed back and right buttock pain when performing straight leg raises. His most recent magnetic resonance imaging study showed an L4-5 moderate to large central disc herniation accompanied by degenerative disc disease and L3-4 disc bulging. The patient’s past medical history included non–insulin-dependent diabetes and a myocardial infarction 16 years before his back injury. His current medications consisted of glyburide, pioglitazone HCl, repaglinide, and clopidogrel bisulfate. The patient was referred to the Cooper Pain Clinic by orthopedic surgery for possible disc decompression after the patient refused to consider lumbar fusion surgery. For the procedure, the patient was transported to the operating room and placed in the prone position for a usual surgical sterile preparation. After administration of 2 mg midazolam for sedation and marking of the L4-L5 vertebral interspace, 1% lidocaine was infiltrated in the skin and deeper tissues overlying the disc space using a 25-G needle. A 17-G dilator and introducer were advanced lateral to the superior articulating process directly into the L4-5 disc space under fluoroscopic guidance. The dilator and introducer positions were confirmed with both postero-anterior and lateral fluoroscopic projection. The Dekompressor unit was then inserted over the stylette, and a percutaneous disc decompression was performed for 1 to 2 minutes using the channeling technique. Approximately ¾ mL of disc nucleus was successfully removed, at which point the attending physician decided to end the procedure and remove the probe. On withdrawal of the Dekompressor unit, it was noted that the probe was no longer connected to the device
Fig 1. Illustration of the handheld Dekompressor device and probe. The black arrow indicates the point of break at approximately 4 inches from the distal probe tip.
Fig 2. The broken probe after removal from the patient. The proximal end of the broken probe shows a 90° curvature made by the surgeon in order to manipulate the probe for extraction.
handle. Fluoroscopic imaging showed that approximately 4 inches of the probe remained in the patient and that the auger’s distal end was still lodged in the disc. The photograph of the fluoroscopy image was of poor quality, and therefore the location of the probe break is shown in Figure 1. A neurosurgeon and an orthopedic surgeon were immediately contacted for assistance with extraction of the broken auger. The patient and his family were notified, and the patient’s level of sedation was maintained to provide comfort throughout the procedure. After assessing the position of the auger, the neurosurgeon infiltrated 1% lidocaine through the skin and into the deeper tissues. An incision was made, and the auger was successfully removed (Fig 2). The skin and deeper tissues were approximated using 4.0 Vicryl sutures (Ethicon, Inc. a Johnson and Johnson Company, Somerville, NJ) and a skin adhesive. The patient tolerated the procedure well and, after recovery in the short procedure unit of the hospital, was discharged home on antibiotic therapy with analgesics (cefadroxil monohydrate 500 mg every 12 hours and 1 Percocet #5 [Endo Pharmaceuticals, Chadds Ford, PA] every 4-6 hours as needed). The patient’s recovery at home was carefully monitored through daily telephone calls from members of the pain management team as well as the Department of Orthopedic Surgery nurse. Two subsequent postsurgery visits to the pain clinic and surgeon revealed a well-healed incision with complete pain relief 2 weeks after surgery. The patient was seen again 1 month later and indicated his back pain was still alleviated and no infection or complications were noted.
Percutaneous Discectomy Probe
Discussion In our limited 1-year experience with this new device and discussions with the manufacturer and other pain experts using this technology, we learned of 2 other incidences of similar probe failure. A search of the FDA Manufacturer and User Facility Device Experience Database confirmed those findings. The first occurrence of a Dekompressor probe failure was reported June 13, 2003, and indicated that the probe tip broke off during the procedure and had to be removed surgically. The brief report states that no patient injury occurred as a result of the event. The second adverse event reported to the FDA Manufacturer and User Facility Device Experience Database provided more information on the nature of the probe break. In this case, it was noted that the cannula was bent about 5° to 10° at the distal end of the probe or approximately the first depth marker location. The physician did hear the auger break followed by increased motor revolutions. The disc surgery had been completed when the auger broke, but surgical removal of the probe was necessary. The report indicates that manipulation of the instrument with bending of the cannula could cause excessive force to be exerted on the auger and therefore result in its breaking distally. We also performed a literature search using Medline as well as the Google search engine using the following search terms alone or in combination: “dekompressor,” “percutaneous disc decompression,” “probe failure,” “auger break,” “arthroscope,” “disc surgery,” and “disc surgery complications,”
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using advanced search strategies and could not find other reports on this type of failure.4 At this time, no specific recommendations have been issued by the manufacturer that are specific to prevention of a probe break such as force specifications or bending. Based on our experience and the review of the 2 other reports of Dekompressor failure, we would caution the physician against applying torque to redirect the probe. It should be noted that the probe may break proximally or distally, in the latter case possibly requiring more extensive surgery for removal of the auger. Manipulation of the auger should be performed in a linear motion as best as possible and under fluoroscopic guidance. Fortunately, there have been no serious adverse outcomes in the 3 patients requiring surgical removal of the probe.
References 1. Ahn Y, Lee SH, Park WM, Lee HY, Shin SW, Kang HY. Percutaneous endoscopic lumbar discectomy for recurrent disc herniation: Surgical technique, outcome, and prognostic factors of 43 consecutive cases. Spine 2004;29:E326-E332. 2. Cragg A, Carl A, Casteneda F, Dickman C, Guterman L, Oliveira C. New percutaneous access method for minimally invasive anterior lumbosacral surgery. J Spinal Disord Tech 2004;17:21-28. 3. Benz RJ, Garfin SR. Current techniques of decompression of the lumbar spine. Clin Orthop Relat Res 2001; 384:75-81. 4. Yeung AT, Tsou PM. Posterolateral endoscopic excision for lumbar disc herniation: surgical technique, outcome, and complications in 307 consecutive cases. Spine 2002;27:722-731.
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atients suffering from chronic low back and leg pain with radicular components because of contained disc herniation, and who have failed conservative therapies, can now be treated with a minimally invasive surgical tool before considering major back surgery.1-3 The probe (Dekompressor Percutaneous Discectomy Probe; Stryker Instruments, Kalamazoo, MI) was designed to aspirate disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine. The procedure is performed under fluoroscopic guidance, requiring only local anesthesia for insertion of the probe. The entire surgical device consists of a battery-operated disposable hand piece connected to a 6-inch long helical percutaneous discectomy probe (auger). The 1.5-mm (17-G) outer-diameter introducer cannula and 1.0-mm (19-G) probe insert provide access to the
From the Department of Anesthesiology, Cooper University Hospital, Robert Wood Johnson Medical School, UMDNJ, Camden, NJ. Accepted for publication October 4, 2005. Reprint requests: Richard Domsky, M.D., Department of Anesthesiology, One Cooper Plaza Suite 298 Kelemen Building, Camden, NJ 08103. E-mail: [email protected] © 2006 by the American Society of Regional Anesthesia and Pain Medicine. 1098-7339/06/3102-0013$32.00/0 doi:10.1016/j.rapm.2005.10.011
disc space while serving as a channel for tissue removal. When activated, the auger rotates and removes nucleus pulposus through the cannula using Archimede’s pump principle. There have been no reports in the literature on the occurrence of a complication from a clean break of the instrument probe requiring its surgical removal from the patient’s disc. We report on such a complication while performing a percutaneous disc decompression at the L4-L5 level using this instrument.
Case Report A 54-year-old man weighing 99 kg and 180 cm tall was referred to the pain clinic for possible percutaneous disc decompression. The patient’s injury originated from a fall resulting in chronic low back pain for the next 8 months, at which time he was seen in the Cooper University Hospital pain clinic. His pain was described as severe and radiating across the lower back, down to the right buttock and thigh. The patient was treated with physical therapy as well as epidural injections that only provided short-term pain relief. A neurologic examination revealed a husky individual with nonantalgic gait who was able to walk on his toes and heels but with limited back mo-
Regional Anesthesia and Pain Medicine, Vol 31, No 2 (March–April), 2006: pp 177–179
177
178
Regional Anesthesia and Pain Medicine Vol. 31 No. 2 March–April 2006
tion and diffuse lower-back tenderness. He had no focal deficits in strength, sensation, or reflexes in the lower extremities but showed back and right buttock pain when performing straight leg raises. His most recent magnetic resonance imaging study showed an L4-5 moderate to large central disc herniation accompanied by degenerative disc disease and L3-4 disc bulging. The patient’s past medical history included non–insulin-dependent diabetes and a myocardial infarction 16 years before his back injury. His current medications consisted of glyburide, pioglitazone HCl, repaglinide, and clopidogrel bisulfate. The patient was referred to the Cooper Pain Clinic by orthopedic surgery for possible disc decompression after the patient refused to consider lumbar fusion surgery. For the procedure, the patient was transported to the operating room and placed in the prone position for a usual surgical sterile preparation. After administration of 2 mg midazolam for sedation and marking of the L4-L5 vertebral interspace, 1% lidocaine was infiltrated in the skin and deeper tissues overlying the disc space using a 25-G needle. A 17-G dilator and introducer were advanced lateral to the superior articulating process directly into the L4-5 disc space under fluoroscopic guidance. The dilator and introducer positions were confirmed with both postero-anterior and lateral fluoroscopic projection. The Dekompressor unit was then inserted over the stylette, and a percutaneous disc decompression was performed for 1 to 2 minutes using the channeling technique. Approximately ¾ mL of disc nucleus was successfully removed, at which point the attending physician decided to end the procedure and remove the probe. On withdrawal of the Dekompressor unit, it was noted that the probe was no longer connected to the device
Fig 1. Illustration of the handheld Dekompressor device and probe. The black arrow indicates the point of break at approximately 4 inches from the distal probe tip.
Fig 2. The broken probe after removal from the patient. The proximal end of the broken probe shows a 90° curvature made by the surgeon in order to manipulate the probe for extraction.
handle. Fluoroscopic imaging showed that approximately 4 inches of the probe remained in the patient and that the auger’s distal end was still lodged in the disc. The photograph of the fluoroscopy image was of poor quality, and therefore the location of the probe break is shown in Figure 1. A neurosurgeon and an orthopedic surgeon were immediately contacted for assistance with extraction of the broken auger. The patient and his family were notified, and the patient’s level of sedation was maintained to provide comfort throughout the procedure. After assessing the position of the auger, the neurosurgeon infiltrated 1% lidocaine through the skin and into the deeper tissues. An incision was made, and the auger was successfully removed (Fig 2). The skin and deeper tissues were approximated using 4.0 Vicryl sutures (Ethicon, Inc. a Johnson and Johnson Company, Somerville, NJ) and a skin adhesive. The patient tolerated the procedure well and, after recovery in the short procedure unit of the hospital, was discharged home on antibiotic therapy with analgesics (cefadroxil monohydrate 500 mg every 12 hours and 1 Percocet #5 [Endo Pharmaceuticals, Chadds Ford, PA] every 4-6 hours as needed). The patient’s recovery at home was carefully monitored through daily telephone calls from members of the pain management team as well as the Department of Orthopedic Surgery nurse. Two subsequent postsurgery visits to the pain clinic and surgeon revealed a well-healed incision with complete pain relief 2 weeks after surgery. The patient was seen again 1 month later and indicated his back pain was still alleviated and no infection or complications were noted.
Percutaneous Discectomy Probe
Discussion In our limited 1-year experience with this new device and discussions with the manufacturer and other pain experts using this technology, we learned of 2 other incidences of similar probe failure. A search of the FDA Manufacturer and User Facility Device Experience Database confirmed those findings. The first occurrence of a Dekompressor probe failure was reported June 13, 2003, and indicated that the probe tip broke off during the procedure and had to be removed surgically. The brief report states that no patient injury occurred as a result of the event. The second adverse event reported to the FDA Manufacturer and User Facility Device Experience Database provided more information on the nature of the probe break. In this case, it was noted that the cannula was bent about 5° to 10° at the distal end of the probe or approximately the first depth marker location. The physician did hear the auger break followed by increased motor revolutions. The disc surgery had been completed when the auger broke, but surgical removal of the probe was necessary. The report indicates that manipulation of the instrument with bending of the cannula could cause excessive force to be exerted on the auger and therefore result in its breaking distally. We also performed a literature search using Medline as well as the Google search engine using the following search terms alone or in combination: “dekompressor,” “percutaneous disc decompression,” “probe failure,” “auger break,” “arthroscope,” “disc surgery,” and “disc surgery complications,”
•
Domsky et al.
179
using advanced search strategies and could not find other reports on this type of failure.4 At this time, no specific recommendations have been issued by the manufacturer that are specific to prevention of a probe break such as force specifications or bending. Based on our experience and the review of the 2 other reports of Dekompressor failure, we would caution the physician against applying torque to redirect the probe. It should be noted that the probe may break proximally or distally, in the latter case possibly requiring more extensive surgery for removal of the auger. Manipulation of the auger should be performed in a linear motion as best as possible and under fluoroscopic guidance. Fortunately, there have been no serious adverse outcomes in the 3 patients requiring surgical removal of the probe.
References 1. Ahn Y, Lee SH, Park WM, Lee HY, Shin SW, Kang HY. Percutaneous endoscopic lumbar discectomy for recurrent disc herniation: Surgical technique, outcome, and prognostic factors of 43 consecutive cases. Spine 2004;29:E326-E332. 2. Cragg A, Carl A, Casteneda F, Dickman C, Guterman L, Oliveira C. New percutaneous access method for minimally invasive anterior lumbosacral surgery. J Spinal Disord Tech 2004;17:21-28. 3. Benz RJ, Garfin SR. Current techniques of decompression of the lumbar spine. Clin Orthop Relat Res 2001; 384:75-81. 4. Yeung AT, Tsou PM. Posterolateral endoscopic excision for lumbar disc herniation: surgical technique, outcome, and complications in 307 consecutive cases. Spine 2002;27:722-731.