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This paper reports on 80 patients using dual electrode, spinal cord stimulation (SCS) over a four-year period Implant status, stimulation mode, anode-cathode configuration (array), cathode position, paresthesia overlap, explantation rates, complications, Visual Analog Scores (VAS), and overall satisfaction were examined in patients implanted with dual 8 contact, staggered, percutaneous electrodes. All patients had undergone implantation for chronic axial and extremity pain [e.g., Failed Back Surgery Syndrome (FBSS), Complex Regional Pain Syndrome (CRPS)]. Outcomes were evaluated in view of our previous reports in this same group at 24 and 30 months (1,2). Data was collected by a disinterested third party. At 48 months, 18 of the original 80 patients were lost to follow-up. Of the 62 patients contacted, 33 remained implanted and 29 (47%) had been explanted. After an average evaluation of 85 arrays (PainDoc, Advanced Neuromodulation Systems, Plano, Texas), 88% of patients reported using one or two "best" arrays (bipolar or guarded tripolar) to maintain favorable paresthesia overlap (89%), VAS reduction (8.1 to 4.9), and overall patient satisfaction (63%). These arrays were most commonly positioned about the physiologic midline of the COL3-4 vertebral segments for upper extremity pain, and the T9-10 vertebral segments for low back and lower extremity pain. In contrast to our initial reports where essentially all patients preferred more than two arrays to maintain "best" paresthesia overlap and outcome, only 12% of these same patients maintained this trend in this long-term follow-up study. The arrays most commonly selected long-term as the "best" ones (88% of all electrodes) were narrow (adjacent contact) bipoles and guarded cathode tripoles (< 8 contacts). Thirty-five percent of patients with thoracic implants achieved paresthesia in the low back at 48 months. Explantation rates and overall patient satisfaction were significantly affected by painful radio frequency (RF) antenna coupling. This data supports the efficacy of dual electrodes in optimizing long-term SCS paresthesia overlap and complex pain outcomes.

Objective. Follow-up of 80 patients using multiple program spinal cord stimulation (SCS). Methods. For 30 months, we followed 80 chronic pain patients who had undergone SCS implantations at our center. Thirty-six patients had Failed Back Surgery Syndrome (FBSS). Patients were evaluated in patient-controlled stimulation mode (patients can select one of several specific programs in response to their activities and pain level). We collected visual analog pain scores, patient satisfaction scores, pain maps, and paresthesia maps. Results. We previously reported our preliminary findings (Neuromodulation 1998;1 :30-45). At 24 months all patients were using more than one program. At 30 months, 62 patients (76%) were using more than two programs as their preferred stimulation mode and three patients (4%) were satisfied with only one stimulation program. At 30 months all patients chose patient-controlled stimulation as their preferred mode of stimulation. A total of 18 patients (23%) were explanted. Mean pain scores declined from 8.2 at baseline to 4.8 (p < 0.05, n= 79). Paresthesia overlap was 91% (n= 79). Of the patients with FBSS, 81% reported that they were using their SCS daily. Conclusions. In spinal cord stimulation the use of multiple electrodes and multiple stimulation programs, together with advanced programmability, increases paresthesia overlap, reduces pain scores, and may improve patient satisfaction with SCS therapy. This study indicates a significant patient preference for multiple program SCS, if patients are given the option to choose between a single program SCS system or a multiple program SCS system.

Objective. The conventional technique used to stimulate the lumbar dermatomes is by stimulation of the dorsal columns of the spinal cord. Until recently, stimulation of nerve roots had not been successfully accomplished. We had performed selective nerve root cannulations for the placement of temporary catheters at cervical, thoracic, lumbar, and sacral levels in chronic pain patients using a caudad rather than craniad approach. We hypothesized that by stimulating the nerve roots we could improve paresthesia coverage in areas which cannot be covered effectively by spinal cord stimulation (SCS). To test this hypothesis, we have performed trials of nerve root stimulation (NRS) in patients who had failed SCS, or who were not candidates for SCS because their pain was otherwise inaccessible to stimulation. Methods. Five patients who had been unresponsive to conservative treatment, surgery, or SCS underwent 7-day trials with NRS. The diagnoses included: ilioinguinal neuralgia, discogenic low back pain, failed back syndrome, vulvodynia, and interstitial cystitis. We collected paresthesia maps, pain maps, pain visual analog scale (VAS) scores, and patient satisfaction ratings. Results. Paresthesia coverage was above 75% in all patients. VAS scores declined from a mean of 9 ± 1.0 to 2.4 ± 2.1 (p < 0.05, n= 5), all 5 patients requested permanent implantation, and 4 have been implanted so far. Conclusions. Lumbar and sacral NRS trials resulted in adequate paresthesia coverage and effective pain relief in all 5 patients. Further clinical trials to evaluate long-term success rates and safety are indicated. Detailed mapping studies are needed to evaluate the relationship between electrode placement and paresthesia patterns as well as the optimal stimulation parameters.

Objective. To evaluate the effectiveness of spinal cord stimulation using multiple independent programmable electrode selections compared to simple continuous stimulation. Design. Prospective case series 2 years. Setting. Ambulatory care center. Patients. All chronic pain patients who underwent spinal cord stimulation treatment at our center from February 1995 until October 1996 entered the study as a consecutive sample (n = 80). Interventions. Patients were evaluated in continuous stimulation mode (single stimulation program) vs. multi-stimulation mode, (patients activate a series of stimulation programs simultaneously to cover all of their pain) and patient-controlled stimulation mode (patients can select a program in response to their activities and pain level). Outcome measures. We collected visual analog pain scores, patient satisfaction scores by stimulation mode, and paresthesia maps. Results. Mean pain scores declined from 8.1 at baseline to 4.6 with continuous stimulation, and to 3.1 with multi-stimulation and with patient-controlled stimulation (p

Release of an aortic crossclamp usually results in hypotension which is mainly due to hypovolemia from sequestration of fluid in the tissues and the release of vasoactive substances (ie, bradykinin, free radicals) that increase capillary permeability. The purpose of this study was to evaluate superoxide dismutase (SOD), a free-radical scavenger, as a pharmacologic technique to prevent hemodynamic changes following aortic crossclamping and release. Fourteen mongrel dogs were studied and divided into two groups. The aorta was clamped for 60 minutes. Group A received NaHCO3, 3.5 mEq/kg, and SOD, 15,000 U/kg; while group B received only NaHCO3, 3.5 mEq/kg, prior to aortic crossclamp release. There was a statistically significant difference in cardiac output, systolic blood pressure, systemic and pulmonary vascular resistances, and arterial oxygen tension between the two groups following aortic crossclamp release. Cardiac output increased from 2.2 +/- .05 to 2.5 +/- .03 L/min (P < .05) after declamping, and returned toward preclamping baseline values after five minutes in group A. In group B, cardiac output decreased from 2.3 +/- .05 to 2.1 +/- .01 (P < .005) after declamping and remained unchanged five minutes later. No statistically significant changes in PaO2 occurred in group A, while there was a significant decrease in PaO2 in group B after crossclamp release. In group B, PaO2 decreased from 95 +/- 7 to 70 +/- 1 mmHg (P < .005) after crossclamp release. Bradykinin levels were almost identical in both groups studied. It is concluded that SOD significantly decreases the cardiovascular changes following aortic crossclamp release.

In children with a ventricular septal defect and congestive heart failure, banding of the pulmonary artery (PA) causes equalization of right and left ventricular pressures, reduces the volume of the left-to-right shunt, and diminishes the work of the left ventricle and the engorgement of the pulmonary vessels. However, banding the PA too tightly usually produces hypoxemia by reversing the left-to-right shunt and causes severe hemodynamic changes. A series of 14 infants is reported who underwent PA banding during which a pulse oximeter was used as an early indicator of excessively tight PA banding. Significant hemodynamic changes occurred in eight infants in whom the PA banding was too tight. This consisted of hypotension and bradycardia three to four minutes after the banding. The eight patients also showed significant desaturation of the blood after application of the band, with the arterial hemoglobin saturation (SaO2) dropping from a preband value of 98 +/- 6% to a postband value of 80 +/- 2%. The decrease in SaO2 preceded the hypotension and bradycardia by two to three minutes in all cases. When the band was removed, the hemodynamic and SaO2 changes returned toward baseline. Subsequently, a less tight band was applied; this was associated with a smaller decrease in SaO2, an elevation of blood pressure, and no bradycardia. This was considered to be acceptable banding. The right ventricle/PA pressure gradient significantly decreased after acceptable banding, and a gradient higher than 45 mmHg was usually associated with hypoxemia.

Paraplegia is a potential complication of aortic cross-clamping. The occurrence of this devastating sequels has caused increased interest in the use of somatosensory evoked responses ISER) to monitor spinal cord ischemia during aortic cross-clamping. This study was designed to examine changes in SERs during clamping and declamping of the canine aorta after injection of superoxide dismutase (SOD), thiopental (T), and nimodipine (N). In the control group, cross-clamping the aorta produced an increase in latency and a decrease in amplitude of the SER starting at two minutes. Isoelectric SERs were obtained after 16 minutes of aortic cross-clamping, but recovered with cross-clamp removal. When the aorta was clamped for more than 16 minutes in the control group, the isoelectric SERs obtained were irreversible. After the injection of SOD and T, SER latencies and amplitudes changed to a smaller degree with aortic cross-clamping and did not become isoelectric even after 20 minutes of clamping. During aortic cross-clamp removal in the control group, SERs initially improved and then showed signs of reperfusion ischemia, which disappeared after eight minutes. There were no significant SER changes due to reperfusion when SOD or T or the combination was given prior to aortic cross-clamping. There was no difference in SER changes from the control group during aortic cross-clamping and after release of cross-clamping when N was given. Nimodipine did not alter SER changes from aortic cross-clamping alone. In summary, SOD and T, alone or in combination, protect the spinal cord against ischemia during aortic cross-clamping and declamping.