Upper airway stimulation for obstructive sleep apnea-Can radiological position monitoring predict tongue motion one year after implantation?

BACKGROUND: Tongue motion patterns (TMP) can influence the outcome of upper airway stimulation (UAS) in the treatment of obstructive sleep apnea (OSA). As a postoperative control, the cuff position of the stimulation lead is monitored via X­ray imaging. A multidimensional X­ray assessment system was established and the association between these positional assessments and TMP was investigated 1 year after implantation. MATERIAL AND METHODS: The study on TMP and the X­ray assessments were carried out at a German ear nose and throat clinic as an implantation center. The TMPs were assessed under bipolar electrode configuration and were categorized according to the currently available literature as right-sided protrusion (RP), left-sided protrusion (LP), bilateral protrusion (BP) and mixed activation (MA). The X­ray assessment was carried out in five dimensions: the position relative to the mandible and hyoid, cuff steepness in the lateral view of the neck, the cuff position based on the single electrode, and the lead connection to the cuff in the anterior-posterior view. The analyses were performed by three raters with different medical backgrounds and knowledge regarding TMP. RESULTS: In approximately 60% of patients, the apnea-hypopnea index was reduced to below 15/h 1 year after implantation. The most common TMPs were RP and BP (82.9%). The interrater variability of the X­ray assessment was good except for one category. Furthermore, no relevant associations were found apart from the correlation between a favorable TMP and the cuff position with respect to the lateral position of the stimulation cable. CONCLUSION: Despite good interrater variability and convenient usage of the suggested X­ray assessment system, this approach did not enable the identification of any associations by which a TM and, therefore, a possible straightforward or complicated treatment pathway could be predicted. Attention should possibly be paid to a rotation of the cuff during implantation with a lateral position of the stimulation lead.

[Upper Airway Stimulation for obstructive sleep apnea-Can radiological position monitoring predict tongue motion one year after implantation? German version]. / Die obere Atemwegsstimulation bei obstruktiver Schlafapnoe ­ Kann die radiologische Lage des Stimulation-Cuff die Zungenbewegung vorhersagen?

BACKGROUND: Tongue motion patterns (TMP) can influence the outcome of upper airway stimulation (UAS) in the treatment of obstructive sleep apnea (OSA). As a postoperative control the cuff position of the stimulation lead is monitored via X­ray imaging. A multidimensional X­ray assessment system was established and the association between these positional assessments and TMP was investigated 1 year after implantation. MATERIAL AND METHODS: The study on TMP and the X­ray assessments were carried out at a German ear nose and throat clinic as an implantation center. The TMPs were assessed under bipolar electrode configuration and were categorized according to the currently available literature as right-sided protrusion (RP), left-sided protrusion (LP), bilateral protrusion (BP) and mixed activation (MA). The X­ray assessment was carried out in five dimensions: the position relative to the mandible and hyoid, cuff steepness in the lateral view of the neck, the cuff position based on the single electrode and the lead connection to the cuff in the anterior-posterior view. The analyses were performed by three raters with different medical backgrounds and knowledge regarding TMP. RESULTS: In approximately 60% of the patients the apnea-hypopnea index was reduced to below 15/h, 1 year after implantation. The most common TMPs were RP and BP (82.9%). The interrater variability of the X­ray assessment was good except for one category. Furthermore, no relevant associations were found apart from the correlation between a favorable TMP and the cuff position with respect to the lateral position of the stimulation cable. CONCLUSION: Despite good interrater variability and convenient usage of the suggested X­ray assessment system, this approach did not enable the identification of any associations, by which a TM and therefore a possible straightforward or complicated treatment pathway could be predicted. Attention should possibly be paid to a rotation of the cuff during implantation with a lateral position of the stimulation lead.

[Clinical trials with medical devices: lack of quality illustrated for faecal incontinence]. / Therapiestudien mit Medizinprodukten: Mangelnde Qualität illustriert anhand analer Inkontinenz.

BACKGROUND: Medical devices must be safe and functioning states the law. Treatments with medical devices need not be efficacious to be allowed. We investigated special requirements and problems arising from the law. METHODS: The market for medical devices is contrasted with that for drugs. The requirements of relevant laws are discussed. Finally, published clinical studies on anal incontinence are analysed with respect to their methodological quality. RESULTS: Clinical trials of medical devices for treat-ing anal incontinence are of poor methodological quality thus preventing evaluation of the devices' utility. CONCLUSION: Large, high quality clinical studies of the efficacy of medical devices for treating anal incontinence are urgently needed. Only such studies enable health technology assessment and comprehensible decisions on reimbursement by health insurance.

[3T-AI: a new treatment algorithm for anal incontinence with a higher evidence level]. / 3T-AI: Ein neuer, mit höherer Evidenz versehener Behandlungsalgorithmus bei analer Inkontinenz.

BACKGROUND: The evidence for conservative treatment of anal incontinence is poor. In our first publication [Schwandner et al. Dis Colon Rectum 2010; 53: 1007-1016] we demonstrated that a novel therapeutic concept, termed triple target treatment (3T), combining amplitude-modulated medium frequency stimulation and electromyography biofeedback (EMG-BF) was superior to EMG-BF alone. Questions about the required treatment duration and the relevant subgroups of patients with sphincter damage and damaged anal sensibility were not addressed. METHODS: We enrolled 158 patients with anal incontinence in this randomized study. Here, we -report on the important subgroup analyses of patients with and without sphincter damage and damaged anal sensibility for the endpoints Cleveland Clinic Score (CCS) and success record. Using the results of this study we propose a novel treatment algorithm which is open for discussion. RESULTS: In patients with sphincter damage, the median difference on the CCS from baseline to 9 months was 5 points higher for 3T than for EMG-BF (95 % confidence interval 0-8; p = 0.0168). While 47 % of the patients with sphincter damage became continent with 3T, only 18 % did with EMG-BF (p = 0.0036). Ten of 17 patients in the 3T group regained anal sensibility after 3 months stimulation. There was tendency towards improved continence in patients with neuropathy upon 3T treatment (p = 0.1219). CONCLUSIONS: 3T is superior to EMG-BF alone for patients with sphincter damage and neuropathic anal incontinence. It is a successful key element within our treatment algorithm, even in patients with sphincter damage and neuropathic anal incontinence.

Bilateral subthalamic stimulation in Parkin and PINK1 parkinsonism.

OBJECTIVES: To study the frequency of different gene mutations in patients with early-onset parkinsonism and bilateral subthalamic nucleus deep brain stimulation (STN-DBS) and the short- and long-term surgical outcome in mutation-positive (MUT+) and -negative (MUT-) patients. METHODS: Eighty patients with disease onset at age