Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study

Jean-Pierre Van Buyten, Frank Wille, Iris Smet, Carin Wensing, Jennifer Breel, Edward Karst, Marieke Devos, Katja Pöggel-Krämer, Jan Vesper, Jean-Pierre Van Buyten, Frank Wille, Iris Smet, Carin Wensing, Jennifer Breel, Edward Karst, Marieke Devos, Katja Pöggel-Krämer, Jan Vesper

Abstract

Objectives: Clinical trials of spinal cord stimulation (SCS) have largely focused on conversion from trial to permanent SCS and the first years after implant. This study evaluates the association of type of SCS and patient characteristics with longer-term therapy-related explants.

Materials and methods: Implanting centers in three European countries conducted a retrospective chart review of SCS systems implanted from 2010 to 2013. Ethics approval or waiver was obtained, and informed consent was not required. The chart review recorded implants, follow-up visits, and date and reasons for any explants through mid-2016. Results are presented using Cox regression to determine factors associated with explant for inadequate pain relief.

Results: Four implanting centers in three countries evaluated 955 implants, with 8720 visits over 2259 years of follow-up. Median age was 53 years; 558 (58%) were female. Explant rate was 7.9% per year. Over half (94 of 180) of explants were for inadequate pain relief, including 32/462 (6.9%) of implants with conventional nonrechargeable SCS, 37/329 (11.2%) with conventional rechargeable and 22/155 (14.2%) with high-frequency (10 kHz) rechargeable SCS. A higher explant rate was found in univariate regression for conventional rechargeable (HR 1.98, p = 0.005) and high-frequency stimulation (HR 1.79, p = 0.035) than nonrechargeable SCS. After covariate adjustment, the elevated explant rate persisted for conventional rechargeable SCS (HR 1.95, p = 0.011), but was not significant for high-frequency stimulation (HR 1.71, p = 0.069).

Conclusions: This international, real-world study found higher explant rates for conventional rechargeable and high-frequency SCS than nonrechargeable systems. The increased rate for conventional rechargeable stimulation persisted after covariate adjustment.

Keywords: Chronic pain; efficacy; explants; outcomes; spinal cord stimulation.

© 2017 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Figures

Figure 1
Figure 1
Consort diagram. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 2
Figure 2
Event timeline. The figure shows a timeline of the 955 SCS systems in the chart review, including unanticipated explants due to inadequate pain relief, unanticipated explants for any other reason, deaths, battery EOL occurrences, upgrades, loss to follow‐up, and SCS systems still in use.
Figure 3
Figure 3
Timing of explants. Each marker indicates an unanticipated explant. As shown in the legend, the color and shape of the marker indicate the type of SCS system.
Figure 4
Figure 4
Cumulative probability of explant using the Kaplan‐Meier estimator. Panel a shows estimated probability of unanticipated explant for any reason, while panel b is probability of explant for inadequate pain relief.
Figure 5
Figure 5
Explants by subgroup. Kaplan‐Meier curves show probability of explant for inadequate pain relief as a function of type of SCS (panel a), age, gender, SCS indication, and predominant pain location (panel b).
Figure 6
Figure 6
Factors associated with explant for inadequate pain relief. Univariate Cox proportional‐hazards regression (left) shows relationship of each individual variable with explants for inadequate pain relief. Multivariable Cox regression (right) includes all variables in a single model. Each point is the Hazard Ratio; lines indicate 95% confidence interval. Significant associations have p value shown in bold.

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