Management of Pharyngeal Fistulas After Anterior Cervical Spine Surgery: A Treatment Algorithm for Severe Complications.

STUDY DESIGN: This study is a retrospective database query to identify all anterior spinal approaches. OBJECTIVES: The objectives were to assess all patients with pharyngocutaneous fistulas (PCFs) after anterior cervical spine surgery. SUMMARY OF BACKGROUND DATA: Patients with the diagnosis of PCFs were treated at the University of Heidelberg Spine Medical Center, Spinal Cord Injury Unit and Department of Otolaryngology (Germany), between 2005 and 2011. METHODS: We conducted a retrospective study on 5 patients with PCF after anterior cervical spine surgery between 2005 and 2011 and analyzed their therapy management and outcome on the basis of the radiologic data and patient charts. RESULTS: Upon presentation, 4 patients were paraplegic. Two patients had PCF arising from 1 piriform sinus, 2 patients had PCF arising from the posterior pharyngeal wall and piriform sinus combined, and 1 patient had PCF arising only from the posterior pharyngeal wall. Two patients previously underwent unsuccessful surgical repair elsewhere and 1 patient underwent a prior radiation therapy. In 3 patients, speech and swallowing could be completely restored. Two patients died, both of whom were paraplegic. The patients were needed to undergo an average of 2 or 3 procedures for complete functional recovery of primary closure with various vascularized regional flaps and refining laser procedures supplemented with the negative pressure wound therapy wherever needed. CONCLUSIONS: On the basis of our experience, we are able to provide a treatment algorithm that indicates that chronic, as opposed to acute, fistulas require a primary surgical closure combined with a vascularized flap that should be accompanied by the immediate application of a negative pressure wound therapy. We also conclude that particularly in paraplegic patients suffering from this complication the risk for a fatal outcome is substantial.

Development and validation of the Functional Rhinoplasty Outcome Inventory 17 (FROI-17).

STATEMENT OF PROBLEM: Quality of life aspects become more and more important in all fields of medicine. There is a lack of such instruments for septorhinoplasty that cover sufficiently both functional and aesthetic aspects. METHODOLOGY: In Phase 1, a group of experts identified 22 questions that represent the symptoms of patients with nasal deformities, which undergo a functional and aesthetic nasal surgery. Forty-one patients filled out the questionnaires before septorhinoplasty. The item assessment and item reduction was performed by a sequential statistical analysis, which included a single item analysis, an assessment of internal consistency, construct validity, the divergence validity and a factor analysis. The resulting 17-item questionnaire was used in a prospective validation study (Phase 2) in which 103 patients were enrolled. Statistical analysis included testing of validity, reliability and responsiveness. RESULTS: In Phase 2 data analysis revealed a good internal consistency and significant test-retest reliability. A literature survey confirmed that the relevant items were included in the questionnaire. We found significant item-score-correlations. Furthermore, the existence of concurrent validity was confirmed. Standardized Response Mean (SRM) as a measure for sensitivity to change indicated moderate to large effects. CONCLUSION: FROI-17 is a valid quality of life instrument for use in septorhinoplasty patients. The instrument is now available for prospective data collection in future septorhinoplasty outcome studies.

Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling.

INTRODUCTION: Induction methods for therapeutic cooling are under investigated. We compared the effectiveness and safety of cold infusions (CI) and nasopharyngeal cooling (NPC) for cooling induction in stroke patients. METHODS: A prospective, open-label, randomised (1:1), single-centre pilot trial with partially blinded safety endpoint assessment was conducted at the neurointensive care unit of Heidelberg University. Intubated stroke patients with an indication for therapeutic cooling and an intracranial pressure (ICP)/temperature brain probe were randomly assigned to CI (4°C, 2L at 4L/h) or NPC (60L/min for 1 h). Previous data suggested a maximum decrease of tympanic temperature for CI (2.1L within 35 min) after 52 min. Therefore the study period was 1 hour (15 min subperiods I-IV). The brain temperature course was the primary endpoint. Secondary measures included continuous monitoring of neurovital parameters and extracerebral temperatures. Statistical analysis based on repeated-measures analysis of variance. RESULTS: Of 221 patients screened, 20 were randomized within 5 months. Infusion time of 2L CI was 33 ± 4 min in 10 patients and 10 patients received NPC for 60 min. During active treatment (first 30 min), brain temperature decreased faster with CI than during NPC (I: -0.31 ± 0.2 versus -0.12 ± 0.1°C, P = 0.008; II: -1.0 ± 0.3 versus -0.49 ± 0.3°C, P = 0.001). In the CI-group, after the infusion was finished, the intervention no longer decreased brain temperature, which increased after 3.5 ± 3.3 min. Oesophageal temperature correlated best with brain temperature during CI and NPC. Tympanic temperature reacted similarly to relative changes of brain temperature during CI, but absolute values slightly differed. CI provoked three severe adverse events during subperiods II-IV (two systolic arterial pressure (SAP), one shivering) compared with four in the NPC-group, all during subperiod I (three SAP, one ICP). Classified as possibly intervention-related, two cases of ventilator failure occurred during NPC. CONCLUSIONS: In intubated stroke patients, brain cooling is faster during CI than during NPC. Importantly, contrary to previous expectations, brain cooling stopped soon after CI cessation. Oesophageal but neither bladder nor rectal temperature is suited as surrogate for brain temperature during CI and NPC. Several severe adverse events in CI and in NPC demand further studying of safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT01573117. Registered 31 March 2012.

Safety evaluation of nasopharyngeal cooling (RhinoChill®) in stroke patients: an observational study.

INTRODUCTION: New technologies for therapeutic cooling have become available. The objective of our study was to investigate the safety of nasopharyngeal cooling with the RhinoChill(®) device in stroke patients, focusing on systemic and neurovital parameters. METHODS: In this prospective observational study, consecutive patients with severe ischemic or hemorrhagic stroke who underwent intracranial pressure (ICP) and brain temperature monitoring have been enrolled. Ten patients who were treated with the RhinoChill(®) device were analyzed. Brain and bladder temperature and systemic and neurovital parameters were monitored continuously. Additional evaluations of safety included bleeding complications and otolaryngological examinations. RESULTS: Baseline brain temperature of 36.7 °C (SD 0.9) decreased by an average of 1.21 °C (SD 0.46) within 1 h, the effect of brain temperature decrease ranged from a maximum of 2 °C (patients 3 and 7) to a minimum of 0.6 °C (patient 4). Within the first several minutes after initiating RhinoChill(®) treatment, 3 of 10 patients experienced an increase in systolic arterial pressure by 30, 30, and 53 mmHg, respectively. Heart rate rose as well (mean 3 bpm, SD 2.9). ICP and oxygen saturation were unaffected by the treatment. We observed 1 bleeding complication in the control CT scan of patient 10. Rhinoscopical findings 3 days after nasopharyngeal cooling and at the follow-up (>6 months) and a 16-item smell test were normal. CONCLUSION: The RhinoChill(®) system cools the brain efficiently. However, steep increases in blood pressure raise serious concerns regarding the safety of its use in stroke patients.

Constrictive pericarditis: risks, aetiologies and outcomes after total pericardiectomy: 24 years of experience.

OBJECTIVES: Constrictive pericarditis is the result of a spectrum of primary cardiac and non-cardiac conditions. Few data exist on the preoperative risk specific to survival after pericardiectomy. This study was designed to compare the association of aetiology of constrictive pericarditis and other clinical variables, with long-term survival after total pericardiectomy. METHODS: A total of 89 patients were studied, who underwent pericardiectomy for constrictive pericarditis at a single surgical centre between 1988 and 2012. Constrictive pericarditis was confirmed by the surgical report. Demographic, pre-, intra- and postoperative data and long-term outcome were investigated. Survival was assessed by the Kaplan-Meier method. RESULTS: Aetiology of constrictive pericarditis was idiopathic in 49 patients (55%), prior cardiac surgery in 21 patients (23.6%), tuberculosis in 5 patients (5.6%), radiation treatment in 5 (5.6%), uraemia in 4 (4.5%), inflammation in 3 (3.5%) myocardial infarction in 2 (2.2%), and perioperative mortality was 7%. Seventy-five percent of patients were in New York Heart Association (NYHA) class III-IV, which status significantly improved in long-term survivors (95% in NYHA I-II). Idiopathic constrictive pericarditis had the best prognosis (5-year Kaplan-Meier survival: 81%) followed by post-surgical (50%) and post-radiation pericarditis (no survivors after 5 years). Tuberculosis, myocardial infarction and uraemia have survival rates comparable with idiopathic aetiology. In addition, preoperative NYHA class IV was associated with significantly lower long-term survival. CONCLUSIONS: Long-term survival after pericardiectomy for constrictive pericarditis is related to underlying aetiology and overall clinical condition. The relatively good survival with idiopathic constrictive pericarditis emphasizes the safety of pericardiectomy in this subgroup.

Assessment of peri- and postoperative complications and Karnofsky-performance status in head and neck cancer patients after radiation or chemoradiation that underwent surgery with regional or free-flap reconstruction for salvage, palliation, or to improve function.

BACKGROUND: Surgery after (chemo)radiation (RCTX/RTX) is felt to be plagued with a high incidence of wound healing complications reported to be as high as 70%. The additional use of vascularized flaps may help to decrease this high rate of complications. Therefore, we examined within a retrospective single-institutional study the peri--and postoperative complications in patients who underwent surgery for salvage, palliation or functional rehabilitation after (chemo)radiation with regional and free flaps. As a second study end point the Karnofsky performance status (KPS) was determined preoperatively and 3 months postoperatively to assess the impact of such extensive procedures on the overall performance status of this heavily pretreated patient population. FINDINGS: 21 patients were treated between 2005 and 2010 in a single institution (17 male, 4 female) for salvage (10/21), palliation (4/21), or functional rehabilitation (7/21). Overall 23 flaps were performed of which 8 were free flaps. Major recipient site complications were observed in only 4 pts. (19%) (1 postoperative haemorrhage, 1 partial flap loss, 2 fistulas) and major donor site complications in 1 pt (wound dehiscence). Also 2 minor donor site complications were observed. The overall complication rate was 33%. There was no free flap loss. Assessment of pre- and postoperative KPS revealed improvement in 13 out of 21 patients (62%). A decline of KPS was noted in only one patient. CONCLUSIONS: We conclude that within this (chemo)radiated patient population surgical interventions for salvage, palliation or improve function can be safely performed once vascularised grafts are used.