Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation

Author:

Larsen Christopher1,Boyd Christopher1ORCID,Villwock Mark1,Steffen Armin2ORCID,Heiser Clemens3,Boon Maurits4,Huntley Colin4ORCID,Doghramji Karl4,Soose Ryan J.5,Kominsky Alan6,Waters Tina6,Withrow Kirk7,Parker Noah8ORCID,Thaler Erica9,Dhanda Patil Reena10,Green Katherine K.11,Chio Eugene12,Suurna Maria13,Schell Amy14,Strohl Kingman14

Affiliation:

1. University of Kansas Medical Center, Kansas City, KS, USA

2. University Clinic Schleswig-Holstein, Lubeck, Germany

3. Technical University of Munich, Munich, Germany

4. Thomas Jefferson University, Philadelphia, PA, USA

5. University of Pittsburgh, Pittsburgh, PA, USA

6. Cleveland Clinic, Cleveland, OH, USA

7. University of Alabama, Birmingham, AL, USA

8. Indiana University School of Medicine, Indianapolis, IN, USA

9. University of Pennsylvania, Philadelphia, PA, USA

10. Cincinnati Veterans Affairs Medical Center, Cincinnati, OH, USA

11. University of Colorado, Denver, CO, USA

12. The Ohio State University, Columbus, OH, USA

13. Weill Cornell Medicine, New York, NY, USA

14. University Hospitals, Cleveland, OH, USA

Abstract

Objective: An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS. Methods: International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher’s Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach. Results: Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups ( P = .808). Operative time exhibited a significant downward trend ( P < .001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, P < .001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, P < .001). ESS outcomes remained equivalent for those with data through 12-months. Conclusions: Across the centers’ first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases.

Funder

Inspire Medical Systems

Publisher

SAGE Publications

Subject

General Medicine,Otorhinolaryngology

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