Long-Term Efficacy of Occipital Nerve Stimulation for Medically Intractable Cluster Headache

Abstract

BACKGROUND Occipital nerve stimulation (ONS) has been proposed to treat refractory chronic cluster headache (rCCH) but its efficacy has only been showed in small short-term series. OBJECTIVE To evaluate ONS long-term efficacy in rCCH. METHODS We studied 105 patients with rCCH, treated by ONS within a multicenter ONS prospective registry. Efficacy was evaluated by frequency, intensity of pain attacks, quality of life (QoL) EuroQol 5 dimensions (EQ5D), functional (Headache Impact Test-6, Migraine Disability Assessment) and emotional (Hospital Anxiety Depression Scale [HAD]) impacts, and medication consumption. RESULTS At last follow-up (mean 43.8 mo), attack frequency was reduced >50% in 69% of the patients. Mean weekly attack frequency decreased from 22.5 at baseline to 9.9 (P < .001) after ONS. Preventive and abortive medications were significantly decreased. Functional impact, anxiety, and QoL significantly improved after ONS. In excellent responders (59% of the patients), attack frequency decreased by 80% and QoL (EQ5D visual analog scale) dramatically improved from 37.8/100 to 73.2/100. When comparing baseline and 1-yr and last follow-up outcomes, efficacy was sustained over time. In multivariable analysis, low preoperative HAD-depression score was correlated to a higher risk of ONS failure. During the follow-up, 67 patients experienced at least one complication, 29 requiring an additional surgery: infection (6%), lead migration (12%) or fracture (4.5%), hardware dysfunction (8.2%), and local pain (20%). CONCLUSION Our results showed that long-term efficacy of ONS in CCH was maintained over time. In responders, ONS induced a major reduction of functional and emotional headache-related impacts and a dramatic improvement of QoL. These results obtained in real-life conditions support its use and dissemination in rCCH patients.

Occipital Nerve Stimulation for Refractory Chronic Cluster Headache: A Cost-Effectiveness Study

“…Age, sex, and socio‐professional category are described in Table 2. Global ONS outcomes have been previously presented (10). Quality of life improvement (EQ‐5D‐3L utility score) was 0.28 ( p < 0.0001) with the ONS strategy.…”

“…All patients were rCCH patients included from February 2013 to January 2015 in the French ONS registry. This previously described registry (9,10) prospectively collected data from patients treated by ONS and used a common evaluation protocol (http://clinicaltrials.gov: NCT01842763). We included in the present study only CCH patients with available preoperative and postoperative economic data.…”

“…The minimum sample size was estimated with the Glick formula using assumptions about the three‐month cost‐effectiveness ratio uncertainty, that was, a difference between the two strategies of €11,000 and 0.05 QALY (10,25). With an alpha risk of 5%, a power of 80% and a €105,000/QALY WTP threshold (i.e., the WHO cost‐effective threshold of three times the GDP per capita (26)), the sample size was 75 patients.…”

“…Long‐term outcome of 105 patients has shown that ONS significantly reduced the attack frequency, and the functional and emotional headache impacts in CCH patients and improved dramatically the health‐related quality of life of responders. However, the complication rate remained relatively high, probably due to the surgical learning curve (10).…”

Occipital Nerve Stimulation for Pain Modulation in Drug-Resistant Chronic Cluster Headache

“…In the second largest cohort with a prolonged follow-up (39.17 months), counting 51 patients, 52.9% exhibited a response to ONS at final follow-up. In the last months of 2020, the series with the largest cohort of patients to date was published [ 22 ]. At the end of follow-up (43.8 months), they reported a reduction in the frequency of attacks of > 50% in 69% of patients.…”