Improvement in quality of life and angina pectoris: 1-year follow-up of patients with refractory angina pectoris and spinal cord stimulation

Abstract

Aims Spinal cord stimulation (SCS) is a treatment for patients with refractory angina pectoris (RAP) who remain symptomatic despite optimal medical therapy and without revascularisation options. Previous studies have shown that SCS improves the quality of life in this patient group and reduces the severity of the angina pectoris. The aim of this prospective, singlearm observational study is to show this effect in a single-centre cohort using a multidisciplinary team approach to the selection process, with a follow-up period of 1 year. Methods and results Between July 2010 and March 2017, 87 patients with RAP referred to our centre received SCS. The Seattle Angina Questionnaire (SAQ) and RAND 36-Item Health Survey (RAND-36) were completed at baseline, prior to implantation, and 1 year post-implantation. After 1 year of followup there was a statistically significant decrease in the frequency of angina pectoris attacks from more than 4 times a day to 1-2 times a week (p < 0.001). The SAQ showed statistically significant improvement in four of the five dimensions: physical limitation (p < 0.001), angina frequency (p < 0.001), angina stability (p < 0.001) and quality of life (p < 0.001). The RAND-36 showed statistically significant improvement in all Electronic supplementary material The online version of this article (

Long-term efficacy and safety of spinal cord stimulation in patients with refractory angina pectoris

“…To our knowledge this study is the first to publish results regarding the efficacy and safety of SCS in patients with RAP with a follow-up period of more than one year [10] , [12] , [16] . Patients in our patient population are relatively young at the time of spinal cord stimulator implantation, 67.3 (±9.0) years.…”

“…The clinical endpoints show that 22.0% (n = 29) of patients with RAP and SCS had an ACS and 32.5% (n = 43) underwent revascularisation (24.2% due to progressive angina pectoris and 8.3% due to an ACS) during the follow-up period. Other studies with a shorter follow-up period, ranging from six up to twelve months, reported occurrence of an ACS in 7.4% up to 10.3%, and revascularisation ranged from 3.3% up to 11.5% during follow-up [9] , [10] , [12] , [23] . These numbers show that the occurrence of a cardiovascular event is to be expected.…”

“…Studies have repeatedly shown that SCS leads to a reduction in the number of angina episodes, less use of short-acting nitrates and a significant improvement in quality of life [7] , [8] , [9] , [10] , [11] , [12] . The average duration of follow-up in these studies range from three months up to one year.…”

Neuromodulation in patients with refractory angina pectoris: a review

“…The patient will be asked to start walking on the treadmill, the pace and angle of the treadmill will be steadily increased until angina is provoked, then TENS is initiated. 47 , 58 Based on the patient response to the TENS test the possible outcomes are: (i) positive: the patient is eligible for SCS, (ii) dubious: trial of two weeks TENS, or (iii) negative: the patient is ineligible for SCS. In case of a dubious test outcome a second evaluation will take place after two weeks of ambulatory TENS which is either positive or negative.…”

“…Reported rates of adverse events are 1% in case of infections and 7.8% in case of device related problems, 76 with an additional study describing an adverse event rate of 2.3% after 1 year of follow-up. 58 An important factor in the risk of adverse events occurring is operator experience. It has been proven in device-related treatment modalities that the experience of the operator significantly impacts the rate of adverse events.…”