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Nature and Science of Sleep 2021The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and...
BACKGROUND
The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remedē System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant.
METHODS
Patients remaining in the Pivotal Trial at the time of FDA approval were invited to enroll in the PAS and consented to undergo sleep studies (scored by a central laboratory), complete the Epworth Sleepiness Scale (ESS) questionnaire to assess daytime sleepiness, and safety assessment. All subjects (treatment and former control group) receiving active therapy were pooled; data from both trials were combined for analysis.
RESULTS
Fifty-three of the original 151 Pivotal Trial patients consented to participate in the PAS and 52 completed the 5-year visit. Following TPNS therapy, the apnea-hypopnea index (AHI), central-apnea index (CAI), arousal index, oxygen desaturation index, and sleep architecture showed sustained improvements. Comparing 5 years to baseline, AHI and CAI decreased significantly (AHI baseline median 46 events/hour vs 17 at 5 years; CAI baseline median 23 events/hour vs 1 at 5 years), though residual hypopneas were present. In parallel, the arousal index, oxygen desaturation index and sleep architecture improved. The ESS improved by a statistically significant median reduction of 3 points at 5 years. Serious adverse events related to implant procedure, device or delivered therapy were reported by 14% of patients which include 16 (9%) patients who underwent a pulse generator reposition or lead revision (primarily in the first year). None of the events caused long-term harm. No unanticipated adverse device effects or related deaths occurred through 5 years.
CONCLUSION
Long-term TPNS safely improves CSA, sleep architecture and daytime sleepiness through 5 years post implant.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01816776.
PubMed: 33953626
DOI: 10.2147/NSS.S300713 -
Folia Medica Cracoviensia Dec 2022The right phrenic nerve is vulnerable to injury (PNI) during cryoballoon ablation (CBA) isolation of the right pulmonary veins. The complication can be transient or... (Meta-Analysis)
Meta-Analysis
The right phrenic nerve is vulnerable to injury (PNI) during cryoballoon ablation (CBA) isolation of the right pulmonary veins. The complication can be transient or persistent. The reported incidence of PNI fluctuates from 4.73% to 24.7% depending on changes over time, CBA generation, and selected protective methods. M e t h o d s: Through September 2019, a database search was performed on MEDLINE, EMBASE, and Cochrane Database. In the selected articles, the references were also extensively searched. The study provides a comprehensive meta-analysis of the overall prevalence of PNI, assesses the transient to persistent PNI ratio, the outcome of using compound motor action potentials (CMAP), and estimated average time to nerve recovery. R e s u l t s: From 2008 to 2019, 10,341 records from 48 trials were included. Out of 783 PNI retrieved from the studies, 589 (5.7%) and 194 (1.9%) were persistent. CMAP caused a significant reduction in the risk of persistent PNI from 2.3% to 1.1% (p = 0.05; odds ratio [OR] 2.13) in all CBA groups. The mean time to PNI recovery extended beyond the hospital discharge was significantly shorter in CMAP group at three months on average versus non CMAP at six months (p = 0.012). CMAP (in contrast to non-CMAP procedures) detects PNI earlier from 4 to 16 sec (p <0.05; I2 = 74.53%) and 3 to 9o (p <0.05; I2 = 97.24%) earlier. C o n c l u s i o n s: Right PNI extending beyond hospitalization is a relatively rare complication. CMAP use causes a significant decrease in the risk of prolonged injury and shortens the time to recovery.
Topics: Humans; Action Potentials; Phrenic Nerve; Hospitalization; Odds Ratio; Peripheral Nerve Injuries
PubMed: 36854091
DOI: 10.24425/fmc.2022.144087 -
Acta Neurologica Belgica Feb 2021Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting the upper and lower motor neurons causing progressive weakness. It eventually involves the...
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting the upper and lower motor neurons causing progressive weakness. It eventually involves the diaphragm which leads to respiratory paralysis and subsequently death. Phrenic nerve (PN) conduction studies and diaphragm ultrasound has been studied and correlated with pulmonary function tests in ALS patients. However, PN ultrasonography has not been employed in ALS. This study aims to sonographically evaluate the morphologic appearance of the PN of ALS patients. Thirty-eight ALS patients and 28 normal controls referred to the neurophysiology laboratory of two institutions were retrospectively included in the study. Baseline demographic and clinical variables such as disease duration, ALS Functional Rating Scale-Revised score, and ALS region of onset were collected. Ultrasound was used to evaluate the PN cross-sectional area (CSA) of ALS and control subjects. The mean PN CSA of ALS patients were 1.08 ± 0.39 mm on the right and 1.02 ± 0.34 mm on the left. The PN CSA of ALS patients were significantly decreased compared to controls (p value < 0.00001). The PN CSA of ALS patients was not correlated to any of the demographic and clinical parameters tested. This study demonstrates that ALS patients have a smaller PN size compared to controls using ultrasonography.
Topics: Adult; Aged; Aged, 80 and over; Amyotrophic Lateral Sclerosis; Female; Humans; Male; Middle Aged; Neural Conduction; Phrenic Nerve; Retrospective Studies; Ultrasonography, Interventional; Young Adult
PubMed: 33136272
DOI: 10.1007/s13760-020-01531-y -
International Journal of Chronic... 2022This review summarizes the characteristics, assessment methods, and targeted rehabilitation therapies of diaphragm dysfunction in patients with chronic obstructive... (Review)
Review
PURPOSE
This review summarizes the characteristics, assessment methods, and targeted rehabilitation therapies of diaphragm dysfunction in patients with chronic obstructive pulmonary disease (COPD).
METHODS
Extensive literature was searched in PubMed, the Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure Database, Wanfang, and SinoMed.
RESULTS
Under the influence of oxidative stress, inflammation, and other factors, the diaphragm function of patients with COPD changes in mobility, muscle strength, thickness, and thickening. In patients with COPD, diaphragm mobility can be assessed using ultrasound, X-ray fluoroscopy, and magnetic resonance imaging. Diaphragmatic strength can be measured by transdiaphragmatic pressure and maximal inspiratory pressure. Diaphragmatic thickness and thickening can be assessed using ultrasound. Rehabilitation therapies targeting the diaphragm include diaphragmatic breathing, diaphragm-related manual therapy, and phrenic nerve electrical stimulation. Diaphragmatic breathing is safe, simple, and not limited by places. Diaphragmatic manual therapies, which require patient cooperation and one-on-one operation by a professional therapist, are effective. Phrenic nerve electrical stimulation is suitable for patients with severe conditions. These therapies improve the diaphragmatic function, lung function, dyspnea, and exercise capacity of patients with COPD.
CONCLUSION
The diaphragmatic function is commonly assessed in terms of mobility, strength, thickness, and thickening. Diaphragmatic targeted rehabilitation therapies have proven to be efficient, which are recommended to be included in the pulmonary rehabilitation strategy for patients with COPD.
Topics: Diaphragm; Dyspnea; Humans; Phrenic Nerve; Pulmonary Disease, Chronic Obstructive; Ultrasonography
PubMed: 35273448
DOI: 10.2147/COPD.S338583 -
Medicina (Kaunas, Lithuania) Sep 2023Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects both the upper and lower motor neurons in the nervous system, causing muscle...
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects both the upper and lower motor neurons in the nervous system, causing muscle weakness and severe disability. The progressive course of the disease reduces the functional capacity of the affected patients, limits daily activities, and leads to complete dependence on caregivers, ultimately resulting in a fatal outcome. Respiratory dysfunction mostly occurs later in the disease and is associated with a worse prognosis. Forty-six participants were included in our study, with 23 patients in the ALS group and 23 individuals in the control group. The ultrasound examination of the phrenic nerve (PN) was performed by two authors using a high-resolution "Philips EPIQ 7" ultrasound machine with a linear 4-18 MHz transducer. Our study revealed that the phrenic nerve is significantly smaller on both sides in ALS patients compared to the control group ( < 0.001). Only one significant study on PN ultrasound in ALS, conducted in Japan, also showed significant results ( < 0.00001). These small studies are particularly promising, as they suggest that ultrasound findings could serve as an additional diagnostic tool for ALS.
Topics: Humans; Amyotrophic Lateral Sclerosis; Phrenic Nerve; Neurodegenerative Diseases; Prognosis; Muscle Weakness
PubMed: 37893463
DOI: 10.3390/medicina59101745 -
Frontiers in Neurology 2022Patients with coronavirus disease 2019 (COVID-19) often develop acute respiratory failure and acute respiratory distress syndrome (ARDS) that requires intensive care...
Patients with coronavirus disease 2019 (COVID-19) often develop acute respiratory failure and acute respiratory distress syndrome (ARDS) that requires intensive care unit (ICU) hospitalization and invasive mechanical ventilation, associated with a high mortality rate. In addition, many patients fail early weaning attempts, further increasing ICU length of stay and mortality. COVID-19 related ARDS can be complicated by neurological involvement with mechanisms of direct central nervous system (CNS) infection and with overlapping para-infective mechanisms of the peripheral nervous system (PNS). We aimed to evaluate the possible involvement of the brainstem and PNS in patients with COVID-19 related ARDS and difficulty in weaning from mechanical ventilation. We evaluated electroencephalogram (EEG), brainstem auditory evoked potentials (BAEPs), electroneurography of the four limbs and the phrenic nerve in 10 patients with respiratory insufficiency due to SARS-CoV-2. All were admitted to intensive care unit and were facing prolonged weaning from mechanical ventilation. All ten patients showed a mild diffuse non-specific slowing of brain electrical activity on the EEG. Four patients had an acute motor axonal neuropathy with absent or reduced amplitude phrenic nerve CMAP while four patients showed impairment of the BAEPs. A patient with peripheral nerve impairment suggestive of Guillain-Barré syndrome (GBS) underwent an intravenous immunoglobulin (IVIg) cycle that led to an improvement in the weaning process and progressive motor improvement. The inclusion of a comprehensive neurological evaluation in COVID-19 patients in ICU facilitated the early identification and effective management of Nervous System involvement.
PubMed: 35651341
DOI: 10.3389/fneur.2022.868538 -
Anesthesiology Research and Practice 2023Peripheral nerve blocks are an increasingly common method of providing postoperative analgesia for shoulder surgeries. However, the standard technique, the interscalene... (Review)
Review
Peripheral nerve blocks are an increasingly common method of providing postoperative analgesia for shoulder surgeries. However, the standard technique, the interscalene block (ISB), inevitably causes hemidiaphragmatic paresis (HDP), secondary to phrenic nerve palsy. This can cause morbidity in patients with preexisting respiratory compromise, prompting investigation into alternative "phrenic-sparing" nerve blocks. The aim of this review was to give an overview of these blocks and critically evaluate the current literature to determine if any are suitable replacements for ISB. The incidence of HDP and analgesic efficacy were considered. We queried four electronic databases and one register. Twenty-eight original articles were selected for review. The use of ultrasound guidance, lower volumes of local anaesthetic (LA), and injection 4 mm outside the brachial plexus fascia reduced HDP incidence for the ISB; however, no single modification did so sufficiently. While the anterior suprascapular nerve block (SSNB) showed comparable analgesic effects to the ISB, HDP prevalence was also high. The posterior SSNB produced consistently low HDP incidences but also inferior analgesia to ISB, except when combined with an infraclavicular brachial plexus block. The superior trunk block (STB) provided equivalent analgesia to the ISB while reducing HDP incidence, but not significantly. Lower LA volumes consistently led to lower HDP incidence across all blocks, likely due to a reduced ability to spread to the phrenic nerve. Further investigation into the minimum effective volumes of the extrafascial ISB, anterior SSNB, STB, and combined posterior SSNB with infraclavicular block is warranted to determine if any of these blocks can successfully balance HDP prevention with analgesic efficacy.
PubMed: 37727810
DOI: 10.1155/2023/9962595 -
Journal of Clinical Neuroscience :... Jul 2022Patients with central apnoea may use electro ventilation, provided their phrenic nerves and diaphragm muscles are normal. A tendency towards better survival has been...
Patients with central apnoea may use electro ventilation, provided their phrenic nerves and diaphragm muscles are normal. A tendency towards better survival has been found, and both an improved quality of life and facilitated nursing have been claimed with electro ventilation compared to mechanical ventilation. The high investment for the device may form a hurdle for fund providers like our hospital administration board. We, therefore, from our first patient onwards, collected clinically meaningful data in a special register of all patients using electro ventilation and their controls on mechanical ventilation. Since 1988 172 patients left our institution dependent on a respiratory device. Of these, all 48 patients with preserved phrenic nerves chose phrenic nerve stimulation. A patient on mechanical ventilation who agreed to participate was chosen as a control (n = 44). All patients were seen at least once a year. 90 patients suffered high tetraplegia, and 2 suffered central apnoea for other reasons. There is a tendency towards better survival, and there is a lower frequency of decubital ulcers (0.02) and respiratory tract infections (p0.000) with electro than with mechanical ventilation. The frequency of respiratory infections turned out to be a better measure of the quality of respiratory care than survival. The resulting decrease in the need for airway nursing, and the reduced incidence of respiratory infections repaid the high investment in electro ventilation within one year in our setting. Informed patients prefer electro to mechanical ventilation; fund providers might also agree with this preference.
Topics: Electric Stimulation Therapy; Humans; Phrenic Nerve; Prospective Studies; Quality of Life; Respiration, Artificial; Respiratory Tract Infections; Sleep Apnea, Central
PubMed: 35512426
DOI: 10.1016/j.jocn.2022.04.037 -
Clinical Microbiology and Infection :... Apr 2024The post-COVID-19 condition (PCC) is a disabling syndrome affecting at least 5%-10% of subjects who survive COVID-19. SARS-CoV-2 mediated vagus nerve dysfunction could...
OBJECTIVES
The post-COVID-19 condition (PCC) is a disabling syndrome affecting at least 5%-10% of subjects who survive COVID-19. SARS-CoV-2 mediated vagus nerve dysfunction could explain some PCC symptoms, such as dysphonia, dysphagia, dyspnea, dizziness, tachycardia, orthostatic hypotension, gastrointestinal disturbances, or neurocognitive complaints.
METHODS
We performed a cross-sectional pilot study in subjects with PCC with symptoms suggesting vagus nerve dysfunction (n = 30) and compared them with subjects fully recovered from acute COVID-19 (n = 14) and with individuals never infected (n = 16). We evaluated the structure and function of the vagus nerve and respiratory muscles.
RESULTS
Participants were mostly women (24 of 30, 80%), and the median age was 44 years (interquartile range [IQR] 35-51 years). Their most prevalent symptoms were cognitive dysfunction 25 of 30 (83%), dyspnea 24 of 30 (80%), and tachycardia 24 of 30 (80%). Compared with COVID-19-recovered and uninfected controls, respectively, subjects with PCC were more likely to show thickening and hyperechogenic vagus nerve in neck ultrasounds (cross-sectional area [CSA] [mean ± standard deviation]: 2.4 ± 0.97mm2 vs. 2 ± 0.52mm2 vs. 1.9 ± 0.73 mm2; p 0.08), reduced esophageal-gastric-intestinal peristalsis (34% vs. 0% vs. 21%; p 0.02), gastroesophageal reflux (34% vs. 19% vs. 7%; p 0.13), and hiatal hernia (25% vs. 0% vs. 7%; p 0.05). Subjects with PCC showed flattening hemidiaphragms (47% vs. 6% vs. 14%; p 0.007), and reductions in maximum inspiratory pressure (62% vs. 6% vs. 17%; p ≤ 0.001), indicating respiratory muscle weakness. The latter findings suggest additional involvement of the phrenic nerve.
DISCUSSION
Vagus and phrenic nerve dysfunction contribute to the complex and multifactorial pathophysiology of PCC.
Topics: Humans; Female; Adult; Middle Aged; Male; COVID-19; Cross-Sectional Studies; SARS-CoV-2; Pilot Projects; Vagus Nerve; Post-Acute COVID-19 Syndrome; Dyspnea; Tachycardia
PubMed: 37984511
DOI: 10.1016/j.cmi.2023.11.007