Detection of Residual Peritoneal Metastases Following Cytoreductive Surgery Using Pegsitacianine, a pH-Sensitive Imaging Agent: Final Results from a Phase II Study.

BACKGROUND: For patients with peritoneal carcinomatosis, extent of disease and completeness of cytoreductive surgery (CRS) are major prognostic factors for long-term survival. Assessment of these factors could be improved using imaging agents. Pegsitacianine is a pH-sensitive polymeric micelle conjugated to the fluorophore indocyanine green. The micelle disassembles in acidic microenvironments, such as tumors, resulting in localized fluorescence unmasking. We assessed the utility of pegsitacianine in detecting residual disease following CRS. PATIENTS AND METHODS: NCT04950166 was a phase II, non-randomized, open-label, multicenter US study. Patients eligible for CRS were administered an intravenous dose of pegsitacianine at 1 mg/kg 24-72 h before surgery. Following CRS, the peritoneal cavity was reexamined under near-infrared (NIR) illumination to evaluate for fluorescent tissue. Fluorescent tissue identified was excised and evaluated by histopathology. The primary outcome was the rate of clinically significant events (CSE), defined as detection of histologically confirmed residual disease excised with pegsitacianine or a revision in the assessment of completeness of CRS. Secondary outcomes included acceptable safety and pegsitacianine performance. RESULTS: A total of 53 patients were screened, 50 enrolled, and 40 were evaluable for CSE across six primary tumor types. Residual disease was detected with pegsitacianine in 20 of 40 (50%) patients. Pegsitacianine showed high sensitivity and was well tolerated with no serious adverse events (SAEs). Transient treatment-related, non-anaphylactic infusion reactions occurred in 28% of patients. CONCLUSIONS: Pegsitacianine was well tolerated and facilitated the recognition of occult residual disease following CRS. The high rate of residual disease detected suggests that the use of pegsitacianine augmented surgeon assessment and performance during CRS.

A prospective randomized study comparing retractor-endoscopic vs. open release of carpal tunnel and cubital tunnel syndromes.

OBJECTIVE: To evaluate the neurological and neurophysiological outcomes of retractor-endoscopic versus open release in carpal tunnel syndrome (rCTS and oCTS, respectively) and cubital tunnel syndrome (rCbTS and oCbTS, respectively) at 3- and 12-month follow-up. METHODS: Between 2013 and 2017, 80 patients were prospectively blindly randomized. McGowan scores were used for preoperative grading and outcomes were assessed using a modified Bishop rating system (BRS). Furthermore, incapacity to work, duration of postoperative pain, hypoesthesia, atrophy, subjective weakness, and a subjective assessment of the operative result were analyzed. The differences in the cohorts were evaluated with t-tests and ANOVAs as parametric tests and Kruskal-Wallis and Mann-Whitney U tests as nonparametric tests. RESULTS: The 80 patients underwent retractor-endoscopic or open decompression of the median or ulnar nerve. The rCTS group exhibited significant improvements in neurophysiological data (P = 0.032), shorter periods of postoperative pain (P = 0.03), and less discomfort (P = 0.005), as well as significantly better BRS results after 3 months compared with the oCTS group (P = 0.005). Between the oCbS and rCbTS groups, no significant differences were observed (P > 0.05). Regarding improvements in McGowan scores, no statistically significant differences were observed between the rCTS and oCTS groups after 3 months (P = 0.52) or 12 months (P = 0.86), nor were any observed between the rCbTS and oCbTS groups after 3 months (P = 0.88) or 12 months (P = 0.10). CONCLUSION: Significantly superior results were obtained at short-term follow-up for rCTS, whereas no superiority was found for rCbTS release. This study concluded that this endoscopic procedure is safe as well as and effective and has the potential to achieve better results in carpal tunnel syndrome compared with conventional methods.

Nerve Graft Length and Recovery of Elbow Flexion Muscle Strength in Patients With Traumatic Brachial Plexus Injuries: Case Series.

BACKGROUND: Traumatic brachial plexus injuries cause long-term maiming of patients. The major target function to restore in complex brachial plexus injury is elbow flexion. OBJECTIVE: To retrospectively analyze the correlation between the length of the nerve graft and the strength of target muscle recovery in extraplexual and intraplexual nerve transfers. METHODS: A total of 51 patients with complete or near-complete brachial plexus injuries were treated with a combination of nerve reconstruction strategies. The phrenic nerve (PN) was used as axon donor in 40 patients and the spinal accessory nerve was used in 11 patients. The recipient nerves were the anterior division of the upper trunk (AD), the musculocutaneous nerve (MC), or the biceps branches of the MC (BBs). An index comparing the strength of elbow flexion between the affected and the healthy arms was correlated with the choice of target nerve recipient and the length of nerve grafts, among other parameters. The mean follow-up was 4 yr. RESULTS: Neither the choice of MC or BB as a recipient nor the length of the nerve graft showed a strong correlation with the strength of elbow flexion. The choice of very proximal recipient nerve (AD) led to axonal misrouting in 25% of the patients in whom no graft was employed. CONCLUSION: The length of the nerve graft is not a negative factor for obtaining good muscle recovery for elbow flexion when using PN or spinal accessory nerve as axon donors in traumatic brachial plexus injuries.

Baha Attract: Our Experience.

In this study, we have highlighted our experience with a new transcutaneous bone conduction hearing device, the Baha Attract System along with finer details on its surgical technique, some challenges faced intraoperatively and the surgical outcome. This study was carried out in our tertiary care hospital over the last 1 year. Our study included the first 4 patients, all of which were males; with a mean age of 13.25 years in whom the new Baha Attract System was used. The mean air-bone gap was 48 dB. Bone smoothening around the implant was needed in 2 patients. We did the switch-on after 6-12 weeks for all the patients where the programmed processor was applied with the help of a magnet at the implanted site. Our study results suggest that the Baha Attract System is promising for the patients with microtia-anotia having conductive or mixed hearing loss. These patients cannot be offered conventional air conduction hearing aids. Their hearing outcomes were comparable to percutaneous Baha systems.

Axillary Intraneural Ganglion Cysts.

Aside from affecting the stability of the glenohumeral joint, tears in the joint capsule can give rise to extraneural (paralabral) and, very rarely, intraneural ganglion cysts. This report presents the first two cases of axillary intraneural ganglion cysts in the literature with magnetic resonance imaging. Both cases were incidentally noted to have coexisting lesions (lymphadenopathy from an undifferentiated malignancy and suprascapular nerve entrapment, respectively). This report reinforces the applicability of the articular theory for intraneural ganglion cysts at a novel site.

Application of a Compact High-Definition Exoscope for Illumination and Magnification in High-Precision Surgical Procedures.

BACKGROUND: The basic necessities for surgical procedures are illumination, exposure, and magnification. These have undergone transformation in par with technology. One of the recent developments is the compact magnifying exoscope system. In this report, we describe the application of this system for surgical operations and discuss its advantages and pitfalls. METHODS: We used the ViTOM exoscope mounted on the mechanical holding arm. The following surgical procedures were conducted: lumbar and cervical spinal canal decompression (n = 5); laminotomy and removal of lumbar migrated disk herniations (n = 4); anterior cervical diskectomy and fusion (n = 1); removal of intraneural schwannomas (n = 2); removal of an acute cerebellar hemorrhage (n = 1); removal of a parafalcine atypical cerebral hematoma caused by a dural arteriovenous fistula (n = 1); and microsutures and anastomoses of a nerve (n = 1), an artery (n = 1), and veins (n = 2). RESULTS: The exoscope offered excellent, magnified, and brilliantly illuminated high-definition images of the surgical field. All surgical operations were successfully completed. The main disadvantage was the adjustment and refocusing using the mechanical holding arm. The time required for the surgical operation under the exoscope was slightly longer than the times required for a similar procedure performed using an operating microscope. CONCLUSIONS: The magnifying exoscope is an effective and nonbulky tool for surgical procedures. In visualization around the corners, the exoscope has better potential than a microscope. With technical and technologic modifications, the exoscope might become the next generation in illumination, visualization, exposure, and magnification for high-precision surgical procedures.

Self-Inflicted Hammer Blows to the Cranial Vault: An Interdisciplinary Challenge.

Depression is predicted to be the most common cause of disability in the coming decade. Self-inflicted hammer blow to the cranium is a rare phenomenon seen in patients with a history of attempted suicide. The resulting comminuted depressed skull fracture of the midline vertex is life threatening. Rapid interdisciplinary communication and intervention are essential to reduce morbidity and mortality. We present a case of self-inflicted hammer blows to the head, review the relevant literature on this topic, and discuss neurosurgical and psychiatric implications.

Tibioperoneal Short Circuiting for Stump Neuroma Pain in Amputees: Revival of an Old Technique.

BACKGROUND: Stump neuroma pain in amputees can be quite challenging. Surgical treatment may be largely subdivided into neuromodulative and non-neuromodulative methods. The latter includes neurocapsis, insertion of nerve stump into the bone marrow, centro-central short circuit (CCSC), and coverage with vascularized soft tissue flaps. CCSC was shown to be extremely effective in alleviation of pain. Reports on CCSC for the treatment of stump neuroma pain have disappeared from the literature, with a shift toward neuromodulation for the treatment of pain irrespective of etiology. METHODS: We observed 8 lower limb amputees undergoing CCSC of the sciatic nerve during a follow-up of 12 years. All had the same stump neuroma pain rendering them unable to wear their prostheses. The sciatic nerve was explored at the midthigh area, much proximal to the amputation site, and a short circuit was established between the tibial and peroneal parts of the nerve. Assessment was by means of pain quantification as per the quadruple visual analogue scale, medication intake, and ability to use prostheses. RESULTS: The median worst quadruple visual analogue scale before surgery was 8.0. After surgery it decreased to 2.5 (P = 0.00094). Medication intake was reduced from regular intake of a combination of opioids, nonsteroidal anti-inflammatory drugs, tricyclic antidepressants, and pregabalin in all patients to irregular intake of nonsteroidal anti-inflammatory drug alone in 3 of 8 patients. All patients were able to wear their limb prosthesis since surgery. CONCLUSIONS: CCSC is a simple, effective, and long-lasting method to treat painful stump neuromas in amputees. It should be strongly considered in deserving cases before resorting to neuromodulative methods.

Retractor-endoscopic nerve decompression in carpal and cubital tunnel syndromes: outcomes in a small series.

OBJECTIVE: To present midterm to long-term results obtained in carpal tunnel release, in situ decompression, and anterior transposition of the ulnar nerve using the retractor integrated endoscope. METHODS: During the period 2000-2010, 145 patients underwent endoscopic carpal tunnel releases (n = 47), endoscopic in situ decompression of the ulnar nerve (n = 55), and endoscopic anterior transposition of the ulnar nerve (n = 52). Bilateral surgery was performed in 9 patients. Independent examinations at 24 months after surgery were used for objective results (Bishop score). Subjective results were procured using a questionnaire. RESULTS: After endoscopic carpal tunnel release, 59.6% of patients showed excellent results, 21.2% showed good results, 12.8% showed fair results, and 6.4% showed poor results according to objective scoring. In 85% of patients, subjective improvement was noted after surgery; symptoms were the same as before surgery in 12.8% of patients and were worse in 2.1% of patients after surgery. After endoscopic in situ decompression, 56.4% of patients showed excellent results on objective scoring, 32.7% showed good results, 9.1% showed fair results, and 1.8% showed poor results. On subjective questioning, 72.7% of patients reported improvement, 20% reported no change in symptoms, and 7.3% reported worse symptoms. After endoscopic anterior transposition of the ulnar nerve, 48.1% of patients showed excellent results on objective scoring, 26.9% showed good results, 23.1% showed fair results, and 1.9% showed poor results. Subjectively, 65.4% of patients reported improvement, 26.9% reported no change in symptoms, and 7.7% reported worse symptoms. Patients with symptom duration of <9 months before surgery showed better results than patients with symptom duration of >9 months. CONCLUSIONS: The retractor-endoscopic technique provides good long-term results after carpal tunnel release, in situ decompression, and anterior subcutaneous transposition of the ulnar nerve. Outcomes showed some correlation to the duration of preoperative symptoms.

The HALOS-ND model: a step in the journey of predicting hospital length of stay after liver transplantation.

Hospital length of stay (LOS) after liver transplantation has been determined to correlate with liver disease severity, post-transplant survival rates, and transplant-associated costs. A patient's model for end-stage liver disease (MELD) score and an organ's Donor risk index (DRI) have both been found to be significant predictors of LOS, but these two factors alone are insufficient to form an accurate prediction. Previous studies have identified other factors predictive of LOS, which can be incorporated with MELD and DRI to create more specific results. The objective of this study was to create an algorithm, or models, based on the most significant LOS predictors as identified from national data at different stages of the transplant process. Four models were developed predicting LOS using recipient factors, payment factors, donor factors, and postoperative factors. A medical care team member can enter a patient's data into the model and receive a reasonably accurate prediction of LOS for each phase of the liver transplant process, specifying the impact of each factor. These predictions would help predict the factors most likely to prolong LOS, inform resource allocation, and provide patients with more specific predictions of their LOS following transplantation.

Open vs retractor-endoscopic in situ decompression of the ulnar nerve in cubital tunnel syndrome: a retrospective cohort study.

BACKGROUND: Both open ulnar nerve decompression and retractor-endoscopic ulnar nerve decompression have been shown to yield good results. However, a comparative evaluation of the techniques is lacking. OBJECTIVE: To compare the results of open and endoscopic surgery in cubital tunnel syndrome. METHODS: One hundred fourteen patients undergoing open (n = 59) or endoscopic (n = 55) decompression of the ulnar nerve for cubital tunnel syndrome were retrospectively compared. The long- and short-term outcomes were compared with respect to the time until return to full activity and the duration of postoperative pain. Additionally, matched pairs between the 2 groups were chosen for analysis (n = 34). RESULTS: Long-term results in the open vs endoscopic groups were as follows: excellent results, 54.2% vs 56.4%; good results, 23.8% vs 32.7%; fair results, 20.3% vs 9.1%; and poor results, 1.7% vs 1.8%, respectively. For the matched pairs, the results had similar significance levels (P = .84). The times until return to full activity in the open vs the endoscopic groups were as follows: 2 to 7 days, 18.6% vs 76.4%; 7 to 14 days, 55.9% vs 10.9%; and > 14 days, 25.4% vs 12.7% (P < .001 between nonmatched and matched pairs). The durations of postoperative pain in the open vs the endoscopic groups were as follows: 1 to 3 days, 45.8% vs 67.3%; 3 to 10 days, 42.5% vs 25.4%; and > 10 days, 11.7% vs 7.3% (P =.04 for nonmatched and P = .05 for matched pairs). CONCLUSION: There are no significant differences in long-term outcomes after open and retractor-endoscopic in situ decompression of the ulnar nerve in cubital tunnel syndrome. The short-term results are significantly better in endoscopic surgery.

A phase 2 randomized trial of paclitaxel and carboplatin with or without panitumumab for first-line treatment of advanced non-small-cell lung cancer.

INTRODUCTION: This two-part phase 2 study evaluated the efficacy and safety of panitumumab, a fully human anti-epidermal growth factor receptor monoclonal antibody, combined with carboplatin/paclitaxel in patients with previously untreated advanced non-small-cell lung cancer. METHODS: In part 1, patients were sequentially enrolled to receive paclitaxel 200 mg/m(2) and carboplatin (area under the concentration-versus-time curve, 6 mg/min/ml) plus panitumumab (1.0, 2.0, or 2.5 mg/kg). In part 2, patients were randomized 2:1 to receive paclitaxel/carboplatin with (arm A) or without (arm B) the maximum tolerated dose of panitumumab identified in part 1. Primary endpoints in parts 1 and 2 were the incidence of dose-limiting toxicities and time to progression (TTP), respectively. RESULTS: In part 1, four of 19 patients had dose-limiting toxicities: three at 2.0 mg/kg (fatigue, pain in extremity, dyspepsia) and one at 2.5 mg/kg (rash). The maximum tolerated dose was not reached; panitumumab 2.5 mg/kg was selected for part 2. In part 2, TTP was 18.1 weeks (95% confidence interval [CI], 13.6-23.3) in arm A and 23.0 weeks (95% CI, 15.9-24.1) in arm B (hazard ratio, 0.9; 90% CI, 0.66-1.21; p = 0.555). Progression-free survival in arms A and B was 17.6 weeks and 18.3 weeks, respectively, and the objective response rate was 15.2% and 11.1%. Adverse events occurring more frequently in arm A than in arm B included skin toxicity, diarrhea, stomatitis, vomiting, and dizziness. Exploratory analyses did not demonstrate associations between potential biomarkers and outcomes. CONCLUSION: Although toxicity was predictable and manageable, the addition of panitumumab to paclitaxel/carboplatin did not improve TTP in patients with previously untreated advanced non-small-cell lung cancer.

Complex wound-healing problems in neurosurgical patients: risk factors, grading and treatment strategy.

BACKGROUND: Wound-healing problems in the neurosurgical patient can be particularly bothersome, owing to various specific risk factors involved. These may vary from simple wound dehiscence to complex multi-layer defects with cerebrospinal fluid (CSF) leakage and contamination. The latter is quite rare in practice and requires an individually titrated reconstruction strategy. The objective is to retrospectively analyze neurosurgical patients with complex, recalcitrant wound-healing problems we had treated in our department, attempt to develop a grading system based on the risk factors specific to our specialty and adapt a surgical reconstruction algorithm. METHODS: During an 11-year period, 49 patients were identified to have had complex, recalcitrant wound-healing problems involving the cranial vault (n = 43) and the skull base (n = 6) that required an adapted surgical wound-management strategy. The etiologies of wound healing problems were aftermaths of surgical treatment of: (1) brain tumors (nine cases), (2) aneurysm clipping (ten cases), (3) trauma (27 patients), and (4) congenital malformations (three patients). Local rotational advancement flaps were performed in 18 patients and free microvascular tissue transfer was performed in 37 cases. RESULTS: Major risk factors leading to recalcitrant wound healing problems in the presented group were: prolonged angiographic interventions (20%), ongoing chemotherapy or radiotherapy (47%), prolonged cortisone application (51%), CSF leak (76%) and, above all, multiple failed attempts at wound closure (94%). Stable long-term wound healing was achieved in all patients using vascularized tissue coverage. A ternary grading system was developed based on various risk factors in the presented cohort. Accordingly, the algorithm for reconstruction in neurosurgical patients was adapted. CONCLUSIONS: Primary disease, treatment history, and distorted anatomical structures are major concerns in the management of complex wound-healing problems in neurosurgical patients. The higher the risk factors involved, the more complex is the surgical strategy. Free microvascular tissue transfer offers stable long-term results in recalcitrant cases. However, this may be indicated only in patients with a good prognosis of the underlying disease.

Recipient-donor race mismatch for African American liver transplant patients with chronic hepatitis C.

African American (AA) recipient-donor race mismatch has been associated with graft loss and mortality, but studies of an association between race mismatch and hepatitis C virus (HCV) disease severity are lacking. HCV-infected adults from 4 US centers who underwent liver transplantation for the first time (n = 1093) were followed for a median of 3.05 years to determine the rates of advanced HCV disease (bridging fibrosis or cirrhosis) and graft failure; 11% of the patients were AA. The unadjusted cumulative rate of advanced fibrosis was higher in AAs than non-AAs (56% and 40% at 4 years, respectively, (P < 0.01), and 59% and 56% for AA recipient-donor-matched patients and AA recipient-donor-mismatched patients, respectively (P = 0.89). In adjusted models, both AA recipient race [hazard ratio (HR) = 1.47, 95% CI = 1.06-2.03, P = 0.02] and AA recipient-donor mismatch (versus match; HR = 1.48, 95% CI = 1.03-2.12, P = 0.03) were significant predictors of advanced fibrosis; other independent predictors were donor age (HR = 1.21, P < 0.01) and cytomegalovirus infection (HR = 1.55, P < 0.01). The 4-year unadjusted cumulative rates for HCV-associated graft loss were 10% and 17% for non-AAs and AAs, respectively (P < 0.01), and 0% and 21% for AA recipient-donor-matched patients and AA recipient-donor-mismatched patients, respectively (P < 0.01). In adjusted models, AA recipient-donor-mismatched patients had a 62% higher rate of graft loss than non-AA recipients (HR = 1.62, 95% CI = 1.14-2.29, P < 0.01), and AA recipient-donor-matched patients had a 76% lower rate of graft loss/mortality (HR = 0.24, 95% CI = 0.06-0.97, P = 0.05). In conclusion, AA recipient-donor-mismatched patients who are infected with HCV are at high risk for advanced HCV disease and HCV-related graft loss and constitute a patient group that will benefit from new therapeutic strategies for preventing graft loss.

Outcomes of microneurovascular facial reanimation using masseteric innervation in patients with long-standing facial palsy resulting from cured brainstem lesions.

BACKGROUND: The functions of the human face are not only of esthetic significance but also extend into metaphoric nuances of psychology. The loss of function of one or both facial nerves has a remarkable impact on patients' lives. OBJECTIVE: To retrospectively analyze the functional outcomes of microneurovascular facial reanimation using masseteric innervation. METHODS: Seventeen patients with irreparable facial paralysis resulting from benign lesions involving the facial nuclei (n = 14) or Möbius syndrome (n = 3) were treated with free muscle flaps for oral commissural reanimation using ipsilateral masseteric innervation and using temporalis muscle transfer for eyelid reanimation. Results were analyzed by the absolute commissural excursion and commissural excursion index and by a patient self-evaluation score. Presence of synkinesis was documented. Follow-up ranged from 8 to 48 months (mean, 26.4 months). RESULTS: Normalization of the commissural excursion index was observed in 8 of 17 patients (47%), an improvement was seen in 7 of 17 (41%), and failure was observed in 2 of 17 (12%). The individual dynamics of absolute commissural excursion and commissural excursion index changes are presented. A natural smiling response was observed in 10 of 17 patients (59%) but not in the remaining 7 (41%). This response reflected the patient's ability to relay the natural emotion of smiling through the masseteric nerve. Patients' self-evaluation scores were a level higher than objective indices. CONCLUSIONS: Innervation of free muscle flaps with the masseteric nerve for oral commissure reanimation might play an important role in patients with lesions of the facial nuclei (as in Möbius syndrome). Synkinesis persists for long periods after surgery. However, most of the patients learned to express their emotions by overcoming this phenomenon. Despite hypercorrection or inadequate correction, patients evaluated themselves favorably.

Sciatic nerve injury model in the axolotl: functional, electrophysiological, and radiographic outcomes.

OBJECT: The 2 aims of this study were as follows: 1) to establish outcome measures of nerve regeneration in an axolotl model of peripheral nerve injury; and 2) to define the timing and completeness of reinnervation in the axolotl following different types of sciatic nerve injury. METHODS: The sciatic nerves in 36 axolotls were exposed bilaterally in 3 groups containing 12 animals each: Group 1, left side sham, right side crush; Group 2, left side sham, right side nerve resected and proximal stump buried; and Group 3 left side cut and sutured, right side cut and sutured with tibial and peroneal divisions reversed. Outcome measures included the following: 1) an axolotl sciatic functional index (ASFI) derived from video swim analysis; 2) motor latencies; and 3) MR imaging evaluation of nerve and muscle edema. RESULTS: For crush injuries, the ASFI returned to baseline by 2 weeks, as did MR imaging parameters and motor latencies. For buried nerves, the ASFI returned to 20% below baseline by 8 weeks, with motor evoked potentials present. On MR imaging, nerve edema peaked at 3 days postintervention and gradually normalized over 12 weeks, whereas muscle denervation was present until a gradual decrease was seen between 4 and 12 weeks. For cut nerves, the ASFI returned to 20% below baseline by Week 4, where it plateaued. Motor evoked potentials were observed at 2-4 weeks, but with an increased latency until Week 6, and MR imaging analysis revealed muscle denervation for 4 weeks. CONCLUSIONS: Multiple outcome measures in which an axolotl model of peripheral nerve injury is used have been established. Based on historical controls, recovery after nerve injury appears to occur earlier and is more complete than in rodents. Further investigation using this model as a successful "blueprint" for nerve regeneration in humans is warranted.