Establishment of a quality management system for the classification, evaluation and improvement of the quality of results in patients after hypoglossal stimulator implantation

Introduction Quality Management Systems (QMS) for the analysis of adverse events are designed to minimize patient risk of treatment. 20-30 % of all patients benefit little from implantation of hypoglossal stimulators (HS), despite compliance with all criteria. To improve the postoperative outcomes, we established an outcome classification and evaluated these according to applicable QM systems.

Methods Following the introduction and improvement of our patient path (Plan-Do-Check-Act analyzes), we established a four-step classification system (K1-4) in the context of a process map and the clinical outcome of the first 20 patients and retrospectively evaluated it using QM Criteria: K1 = apnea hypopnea index (AHI)  <  5, K2 = AHI reduction > 50 %, K3 = AHI reduction  < 50 % but improvement in daytime sleepiness (ESS), K4 = no improvement in AHI/ESS.

Results 16 of 20 patients met all QMS criteria. 10 patients were in K1, 1 patient in K2, 3 patients in K3 and 2 patients in K4. Process analyzes showed that in 4 out of 6 patients in K3/4 the titration night in the sleep laboratory was performed before reaching the maximum individual stimulus intensity. In one patient the retrospective view of the preoperative measurement in the sleep laboratory was erroneous, in two patients in K3/4 an UVPP was done in the past.

Conclusion Based on classification analysis, as opposed to the individual consideration, we concluded that the introduction of better monitoring of patient adherence, the development of a quality standard for the evaluation of extraneous findings and the critical consideration of pre-operated patients in relation to a concentric collapse are necessary.

Poster-PDF A-1510.PDF

Publication History

Article published online:
10 June 2020