Using subcutaneous nerve stimulation for rate control of atrial fibrillation v1

Author(s):  
Peng Sheng Chen

Study Description: Patients will have a 1:1 randomization to receive subcutaneous electrical nerve stimulation (ScNS) to observe if the stimulation can reduce atrial fibrillation burden in patients with symptomatic atrial fibrillation (AF). All subjects will undergo the implant of a neurostimulator lead. The experimental group will receive stimulation and the control group will not receive stimulation. All subjects will complete the same follow up visits to compare the 2 groups Objectives: Primary Objective: To test the hypothesis that chronic subcutaneous nerve stimulation can reduce AF burden in patients with severe symptomatic AF unresponsive to conventional therapies The secondary objective: To test the hypotheses that the effect of ScNS on the following endpoints is different between the two randomization groups: 1) Time-dependent reduction of AF burden 2) Effects of ScNS on ventricular rate control during AF Endpoints: Primary Objective: To test the hypothesis that chronic subcutaneous nerve stimulation can reduce AF burden in patients with severe symptomatic AF unresponsive to conventional therapies The secondary objective: To test the hypotheses that the effect of ScNS on the following endpoints is different between the two randomization groups: 1) Time-dependent reduction of AF burden 2) Effects of ScNS on ventricular rate control during AF 3) Reduction of SKNA 4) Improvement of quality of life •The primary Efficacy Endpoint: The average AF burden. •The secondary Efficacy Endpoint(s): 1) Time-dependent reduction of AF burden 2) Ventricular rate during AF 3) average SKNA 4) Quality of life Study Population: The study will enroll patients with symptomatic atrial fibrillation unresponsive to conventional therapy defined by not responding to at least 1 antiarrhythmic drug.The study will enroll 30 patients, including 15 men and 15 women between the 18 and 75 years old. There will be no sex/gender/racial/ethnic based exclusion. Patients will be enrolled from the Cedars Sinai Medical Center. Phase: Not applicable Description of Sites/Facilities Enrolling Participants: The study will enroll patients treated at the Cedars-Sinai Medical Center. This is a single site study. Description of Study Intervention: The patients will undergo surgical implantation of an externalized lead under the skin on the chest wall. The wire is then connected to a neurostimulator. The experimental group (Group A) will receive ScNS (3.5 mA) for two weeks. The shame group (Group B) will receive sham (0 mA) stimulation for two weeks. The AF burden will be assessed by a 7-day mobile cardiac telemetry. Study Duration: 36 months Participant Duration: Up to 4 months.

1999 ◽  
Vol 34 (7) ◽  
pp. 2043-2050 ◽  
Author(s):  
Patrick Schauerte ◽  
Benjamin J Scherlag ◽  
Michael A Scherlag ◽  
Sunil Goli ◽  
Warren M Jackman ◽  
...  

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ariana S. Dalgleish ◽  
Adrienne M. Kania ◽  
Harald M. Stauss ◽  
Adrianna Z. Jelen

Abstract Context Management of atrial fibrillation includes either rhythm control that aims at establishing a sinus rhythm or rate control that aims at lowering the ventricular rate, usually with atrioventricular nodal blocking agents. Another potential strategy for ventricular rate control is to induce a negative dromotropic effect by augmenting cardiac vagal activity, which might be possible through noninvasive and nonpharmacologic techniques. Thus, the hypothesis of this study was that occipitoatlantal decompression (OA-D) and transcutaneous auricular vagus nerve stimulation (taVNS) not only increase cardiac parasympathetic tone as assessed by heart rate variability (HRV), but also slow atrioventricular conduction, assessed by the PQ-interval of the electrocardiogram (EKG) in generally healthy study participants without atrial fibrillation. Objectives To test whether OA-D and/or transcutaneous taVNS, which have been demonstrated to increase cardiac parasympathetic nervous system activity, would also elicit a negative dromotropic effect and prolong atrioventricular conduction. Methods EKGs were recorded in 28 healthy volunteers on three consecutive days during a 30 min baseline recording, a 15 min intervention, and a 30 min recovery period. Participants were randomly assigned to one of three experimental groups that differed in the 15 min intervention. The first group received OA-D for 5 min, followed by 10 min of rest. The second group received 15 min of taVNS. The intervention in the third group that served as a time control group (CTR) consisted of 15 min of rest. The RR- and PQ-intervals were extracted from the EKGs and then used to assess HRV and AV-conduction, respectively. Results The OA-D group had nine participants (32.1%), the taVNS group had 10 participants (35.7%), and the CTR group had nine participants (32.1%). The root mean square of successive differences between normal heartbeats (RMSSD), an HRV measure of cardiac parasympathetic modulation, tended to be higher during the recovery period than during the baseline recording in the OA-D group (mean ± standard error of the mean [SEM], 54.6 ± 15.5 vs. 49.8 ± 15.8 ms; p<0.10) and increased significantly in the taVNS group (mean ± SEM, 28.8 ± 5.7 vs. 24.7 ± 4.8 ms; p<0.05), but not in the control group (mean ± SEM, 31.4 ± 4.2 vs. 28.5 ± 3.8 ms; p=0.31). This increase in RMSSD was accompanied by a lengthening of the PQ-interval in the OA-D (mean ± SEM, 170.5 ± 9.6 vs. 166.8 ± 9.7 ms; p<0.05) and taVNS (mean ± SEM, 166.6 ± 6.0 vs. 162.1 ± 5.6 ms; p<0.05) groups, but not in the control group (mean ± SEM, 164.3 ± 9.2 vs. 163.1 ± 9.1 ms; p=0.31). The PQ-intervals during the baseline recordings did not differ on the three study days in any of the three groups, suggesting that the negative dromotropic effect of OA-D and taVNS did not last into the following day. Conclusions The lengthening of the PQ-interval in the OA-D and taVNS groups was accompanied by an increase in RMSSD. This implies that the negative dromotropic effects of OA-D and taVNS are mediated through an increase in cardiac parasympathetic tone. Whether these findings suggest their utility in controlling ventricular rates during persistent atrial fibrillation remains to be determined.


2016 ◽  
Vol 10 (1) ◽  
pp. 26
Author(s):  
Pragnesh Parikh ◽  
◽  
KL Venkatachalam ◽  

Atrial fibrillation (AF) is the most common arrhythmia noted in clinical practice and its incidence and prevalence are on the rise. The single most important intervention is the evaluation and treatment of stroke risk. Once the risk for stroke has been minimized, controlling the ventricular rate and treating symptoms become relevant. In this review article, we emphasize the importance of confirming and treating the appropriate arrhythmia and correlating symptoms with rhythm changes. Furthermore, we evaluate some of the risk factors for AF that independently result in symptoms, underlining the need to treat these risk factors as part of symptom control. We then discuss existing and novel approaches to rate control in AF and briefly cover rhythm control methods.


2018 ◽  
Vol 88 (2) ◽  
Author(s):  
Stefano Fumagalli ◽  
Serena Boni ◽  
Simone Pupo ◽  
Marta Migliorini ◽  
Irene Marozzi ◽  
...  

Atrial fibrillation (AF) is the most frequent arrhythmia in elderly people. Findings derived from clinical trials seem to demonstrate that a rate-control strategy of AF in aged patients improves prognosis if compared to a rhythm-control one. However, epidemiological studies concordantly show that the arrhythmia is associated to increased hospitalization and mortality rates. In last years, the proportion of patients admitted to hospital for AF has progressively increased; this trend is observed in subjects >75 and >85 years, while no change was found in younger cohorts. Importantly, in aged individuals, probably because of the loss of atrial activity, the increase of heart rate and the irregularity of RR intervals, AF begins a vicious cycle, leading from heart failure, through the compromise of functional and neurocognitive status, to overt disability, dementia and increased mortality. Evidence specifically aimed at clarifying the effects of arrhythmia management on outcomes characteristic of aged people is completely lacking. In the elderly, the question regarding the effects of a rate- or a rhythm-control strategy of AF should be considered as an aspect of a more complex strategy, addressed to reduce disability and hospitalizations, and to improve quality of life and survival.


2019 ◽  
Vol 9 (3) ◽  
pp. 157
Author(s):  
Yoo Mi Lee ◽  
Young Sun Cho ◽  
Su Jin Jeong

Background: Approximately 70% of all newborns in South Korea are fed a commercial formula as their sole source of nutrition or as a supplement to breast milk. It is common for many formula-fed infants to be switched from one formula to another because of perceived abnormalities in stooling patterns (too much/too little, too hard/too loose). Also, probiotics may have been recommended by a clinician or practitioner when there is thought to be a problem with the babies stool based on many reports.Aims: The primary objective of this study was to determine whether probiotic (nLp-nF1) exposure during the first 6 months of life is safe. The secondary objective was to assess if nF1 exposure correlated with changes in formula-fed infants’ stool characteristics.Result: We recruited 49 healthy formula-fed infants aged 0-6 months from Bundang Cha Medical Center. Infants were given a 14-day supply of probiotics (nf1: Lactobacillus plantarum 2.5 X 1010/g/pack, 2 pack/day). The overall rate of stool change after probiotics is 83% (41/49). Among them, 75.6% (31/41) participants answered fairly about the change of stool characteristics. The significant change of stool frequency, stool color and flatulence after probiotics intervention was reported. The number of infants who defecated once daily was increased from 53% (26 of 49) to 77.5% (38 of 49) (P=0.075). Mustard yellow colored feces increased from 22 to 40 (p=0.018). Only 9 out of 20 infants with flatulence (>3 times) showed persistence of symptoms after probiotics (p<0.001). After taking probiotics, Bristol Stool Scale 4-5 stool was reported from 23 to 37(p=0.018).Conclusion: By taking probiotics, the color of the stool changed, and the incidence of flatulence production decreased. Although the results are not statistically significant, the quality and quantity of stool improved according to the Bristol Stool Scale.Keywords: Probiotics, Bristol Stool Scale, stool


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