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Open letter to surgeons performing chemonucleolysis (from a surgeon performing chemonucleolysis)
Surg Neurol 1985;24:587-8
587
Letters to the Editor Open Letter to Surgeons Performing Chemonucleolysis (From a surgeon performing chemonucleolysis) The injection of chymopapain into the nucleus of a herniated disk relieves the sciatic pain resulting from the herniation. The contention is that the nucleus reduces its size, thus decompressing the trapped nerve root. We surgeons performing chemonucleolysis in large numbers are impressed by the safety of this highly successful procedure. But we are most disturbed by the publications in the medical and nonmedical literature of many complications, side effects, and catastrophes that we are not encountering. We believe that most of those mishaps do relate to poor technique and poor patient selection. We are concerned that should the present trend continue we will face two consequences: (a) the withdrawal of the most effective therapeutic modality for ruptured disks; (b) the reaction of the drug manufacturers who, in order to keep the product going, will outline "policies and recommendations" increasingly unrealistic, complex, not to say dangerous. The following basic points should be clearly understood before performing chemonucleolysis: The needle must be into a herniated disk. The needle must be into the nucleus of the disk. The needle must not have crossed the dura or the nerve root.
The injection must not be carried out on a patient allergic to chymopapain. Sterile and active enzyme should be injected. Although those five points do appear basic, it is our opinion that they were actually violated in each case of complication or poor result. We have carefully analyzed each published complication on a case by case basis. In reviewing these reports we also took the "unbiased" view that the reporting surgeon's opinion about the actual cause of the complication might be itself "biased" in order to avoid some legal action. In each case of complication, either an obvious error was made (needle and drugs entering the spinal fluid or lack of adequate allergic testing), or there was at least doubt left over those points (unreadable intraoperative radiographies, multiple needle attempts before entering the disk, etc.). We also believe that the poor results achieved are related to the same type of reason. For instance, the fact that an injected disk did not lose height indicates that the nucleus was not injected or was injected with an inactive enzyme. We have actually seen cases in which the surgeon experiencing difficulties with the needle placement elected to inject the disk space with an inactive substance (so-called "placebo injection") rather than taking the risk to harm the patient and © 1985 by Elsevier Science Publishing Co., Inc.
inject lytic substance into a nerve root. (Withdrawing without injection and acknowledging this fact will be seen negatively by an irate patient and poorly reimbursed by the insurance carrier. ) We want to address now the issue of the injected enzyme. Chymopapain must be both active and sterile. Active enzyme must be delivered by the manufacturer and we certainly wish it to be the case. It must be handled with care until it reaches the surgeon's syringe (and we hope that the containers do not lie around in some airport warehouse). It must be injected in adequate amounts and in a sterile fashion, as bacteria may cause infection or may destroy the enzyme. We wish that a rapid intraoperative test be developed by which the enzyme is placed over a filter paper, for example, and proven active by some "magic" color change before injection. In this letter we request honesty, knowledge, and ethics from surgeons performing chemonucleolysis. We also request them to learn the technique in order to be able to enter any lumbar disk without errors and to inject only proven ruptured disks in suitable patients. We are appealing to the manufacturers of the enzymes to keep high technical manufacturing standards to develop intraoperative control testing for the drug. To support and develop training courses and to keep a cool and reasonable approach in front of the news media and the medical community. We are most concerned that should the present trend be followed, we will face again a withdrawal of chemonucleolysis to the deep sorrow of the patient and the surgeon. Maurice Romy, M.D.
Philadelphia, Pennsylvania
Hemiballismus from Hematoma in Caudate Nucleus To the Editor: The article "Choreoballismus: A Nonhemorrhagic Complication of Venous Angioma" by Burke et al (Surg Neurol 1984;21:245-8) was of interest to us because of a case that we observed. A 75-year-old man suddenly developed violent, brisk involuntary movements of his right extremities. These were aggravated by emotional stress and voluntary movements, and were decreased during rest and sleep. A computed tomography scan disclosed a circular hyperdensity in the head of the left caudate nucleus (Figure 1). Under neuroleptic medication these movements disappeared in 3 weeks. A second computed tomography scan revealed that the hyperdensity had disappeared. We believe that this lesion was a hematoma. A lesion in the caudate nucleus is an 0090-3019/85/$3.30
587
Letters to the Editor Open Letter to Surgeons Performing Chemonucleolysis (From a surgeon performing chemonucleolysis) The injection of chymopapain into the nucleus of a herniated disk relieves the sciatic pain resulting from the herniation. The contention is that the nucleus reduces its size, thus decompressing the trapped nerve root. We surgeons performing chemonucleolysis in large numbers are impressed by the safety of this highly successful procedure. But we are most disturbed by the publications in the medical and nonmedical literature of many complications, side effects, and catastrophes that we are not encountering. We believe that most of those mishaps do relate to poor technique and poor patient selection. We are concerned that should the present trend continue we will face two consequences: (a) the withdrawal of the most effective therapeutic modality for ruptured disks; (b) the reaction of the drug manufacturers who, in order to keep the product going, will outline "policies and recommendations" increasingly unrealistic, complex, not to say dangerous. The following basic points should be clearly understood before performing chemonucleolysis: The needle must be into a herniated disk. The needle must be into the nucleus of the disk. The needle must not have crossed the dura or the nerve root.
The injection must not be carried out on a patient allergic to chymopapain. Sterile and active enzyme should be injected. Although those five points do appear basic, it is our opinion that they were actually violated in each case of complication or poor result. We have carefully analyzed each published complication on a case by case basis. In reviewing these reports we also took the "unbiased" view that the reporting surgeon's opinion about the actual cause of the complication might be itself "biased" in order to avoid some legal action. In each case of complication, either an obvious error was made (needle and drugs entering the spinal fluid or lack of adequate allergic testing), or there was at least doubt left over those points (unreadable intraoperative radiographies, multiple needle attempts before entering the disk, etc.). We also believe that the poor results achieved are related to the same type of reason. For instance, the fact that an injected disk did not lose height indicates that the nucleus was not injected or was injected with an inactive enzyme. We have actually seen cases in which the surgeon experiencing difficulties with the needle placement elected to inject the disk space with an inactive substance (so-called "placebo injection") rather than taking the risk to harm the patient and © 1985 by Elsevier Science Publishing Co., Inc.
inject lytic substance into a nerve root. (Withdrawing without injection and acknowledging this fact will be seen negatively by an irate patient and poorly reimbursed by the insurance carrier. ) We want to address now the issue of the injected enzyme. Chymopapain must be both active and sterile. Active enzyme must be delivered by the manufacturer and we certainly wish it to be the case. It must be handled with care until it reaches the surgeon's syringe (and we hope that the containers do not lie around in some airport warehouse). It must be injected in adequate amounts and in a sterile fashion, as bacteria may cause infection or may destroy the enzyme. We wish that a rapid intraoperative test be developed by which the enzyme is placed over a filter paper, for example, and proven active by some "magic" color change before injection. In this letter we request honesty, knowledge, and ethics from surgeons performing chemonucleolysis. We also request them to learn the technique in order to be able to enter any lumbar disk without errors and to inject only proven ruptured disks in suitable patients. We are appealing to the manufacturers of the enzymes to keep high technical manufacturing standards to develop intraoperative control testing for the drug. To support and develop training courses and to keep a cool and reasonable approach in front of the news media and the medical community. We are most concerned that should the present trend be followed, we will face again a withdrawal of chemonucleolysis to the deep sorrow of the patient and the surgeon. Maurice Romy, M.D.
Philadelphia, Pennsylvania
Hemiballismus from Hematoma in Caudate Nucleus To the Editor: The article "Choreoballismus: A Nonhemorrhagic Complication of Venous Angioma" by Burke et al (Surg Neurol 1984;21:245-8) was of interest to us because of a case that we observed. A 75-year-old man suddenly developed violent, brisk involuntary movements of his right extremities. These were aggravated by emotional stress and voluntary movements, and were decreased during rest and sleep. A computed tomography scan disclosed a circular hyperdensity in the head of the left caudate nucleus (Figure 1). Under neuroleptic medication these movements disappeared in 3 weeks. A second computed tomography scan revealed that the hyperdensity had disappeared. We believe that this lesion was a hematoma. A lesion in the caudate nucleus is an 0090-3019/85/$3.30