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Respicardia wins FDA nod for Remed ē central sleep apnea neurostim device

Respicardia said today that it won FDA approval for its Remedē transvenous implantable neurostimulation system designed to treat patients with central sleep apnea. Central sleep apnea occurs when the brain fails to control breathing during sleep, unlike the more common obstructive sleep apnea which consists of a partially collapsed airway which causes pauses in breathing, Respicardia said. The Remedē system consists of a surgically placed battery packa nd thin wires inserted into the blood vessels in the chest near the phrenic nerve, which it stimulates to engage the diaphragm to restore natural breating during sleep and improve patient quality of life and satisfaction. “This implantable device offers patients another treatment option for central sleep apnea. Patients should speak with their health care providers about the benefits and risks of this new treatment compared to other available treatments,” FDA CDRH anesthesiology, general hospital, respiratory, infection control and dental devices acting director Tina Kiang said in a prepared FDA release. Approval of the device came based off data from the Minnetonka, Minn.-based company’s pivotal trial of the device, which had results published in the Lancet last September. The 151-patient, 31-hospital study aimed to explore the safety and effectiveness of a transvenous phrenic nerve stimulator which is designed to send regular signals to get the diaphragm to breathe during sleep. At 6-months, the number of ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Respiratory Respicardia Source Type: news

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Conclusions The STOP Bang questionnaire was not able to predict difficult airway and mild obstructive sleep apnea syndrome, but it identified marked obstructive sleep apnea syndrome. All patients with difficult airway had moderate and marked obstructive sleep apnea syndrome, although this syndrome did not involve difficult airway. The variables Cormack III/IV and BMI greater than 35kgm−2 were able to predict difficult airway and obstructive sleep apnea syndrome, respectively.
Source: Brazilian Journal of Anesthesiology - Category: Anesthesiology Source Type: research
Anesthesia, sedation, and analgesia can negatively impact adult patients with obstructive sleep apnea (OSA). Despite known risks, current evidence, and practice guidelines, insufficient evidence exists that standardization and clinical application of OSA screening tools, problem identification, and perioperative nursing intervention and management strategies are consistently implemented for OSA patients across perianesthesia settings. The purpose of this study was to conduct a knowledge and practice assessment of perianesthesia nurses who care for adult patients with diagnosed or undiagnosed OSA.
Source: Journal of PeriAnesthesia Nursing - Category: Nursing Authors: Tags: Original Article Source Type: research
This study is a prospective, observational study of ambulatory patients undergoing orthopedic surgery on an extremity. Study subjects completed three unattended home sleep apnea tests: baseline before surgery, the first night after surgery (N1), and third night after surgery (N3). Anesthesia and surgical teams were blinded to study participation and patients received routine perioperative care.Results:Two hundred three subjects were enrolled and 166 completed the baseline home sleep test. Sixty-six (40.0%) had OSA at baseline, 35 patients received a new diagnosis, and 31 patients had a previous diagnosis of OSA. Of those w...
Source: Journal of Clinical Sleep Medicine : JCSM - Category: Sleep Medicine Source Type: research
Authors: Seelhammer TG, DeGraff EM, Behrens TJ, Robinson JC, Selleck KL, Schroeder DR, Sprung J, Weingarten TN Abstract BACKGROUND AND OBJECTIVES: The primary aim was to determine risk factors for flumazenil administration during postanesthesia recovery. A secondary aim was to describe outcomes among patients who received flumazenil. METHODS: Patients admitted to the postanesthesia recovery room at a large, academic, tertiary care facility after surgery under general anesthesia from January 1, 2010, to April 30, 2015, were identified and matched to 2 controls each, by age, sex, and surgical procedure. Flumazeni...
Source: Revista Brasileira de Anestesiologia - Category: Anesthesiology Tags: Rev Bras Anestesiol Source Type: research
Abstract Among obese pregnant women, 15%-20% have obstructive sleep apnea (OSA) and this prevalence increases along with body mass index and in the presence of other comorbidities. Prepregnancy obesity and pregnancy-related weight gain are certainly risk factors for sleep-disordered breathing in pregnancy, but certain physiologic changes of pregnancy may also increase a woman's risk of developing or worsening OSA. While it has been shown that untreated OSA in postmenopausal women is associated with a range of cardiovascular, pulmonary, and metabolic comorbidities, a body of literature is emerging that suggests OSA...
Source: Anesthesia and Analgesia - Category: Anesthesiology Authors: Tags: Anesth Analg Source Type: research
Authors: Elmoutaz Mahmoud H, Rashwan DAE Abstract Patients with sleep apnea are prone to postoperative respiratory complications, requiring restriction of sedatives during perioperative care. We performed a prospective randomized study on 24 patients with obstructive sleep apnea (OSA) who underwent elective surgery under general anesthesia. The patients were equally divided into two groups: Group Dex: received dexmedetomidine loading dose 1 mcg/kg IV over 10 min followed by infusion of 0.2-0.7 mcg/kg/hr; Group KFL: received ketofol as an initial bolus dose 500 mcg/kg IV (ketamine/propofo...
Source: Critical Care Research and Practice - Category: Intensive Care Tags: Crit Care Res Pract Source Type: research
ConclusionElderly patients undergoing LSG usually have excellent postoperative course despite the associated high risk and the required ICU admission. The number of comorbidities, diagnosis of OSA, and ASA score are possible clinically significant predictive factors for the need of post-LSG ICU admission.
Source: Obesity Surgery - Category: Surgery Source Type: research
Abstract Obesity is often associated with obstructive sleep apnea (OSA), which increases the risk of intraoperative and postoperative complications. The role of preoperative screening of OSA is crucial, with adequate management based on continuous positive pressure before, during and after surgery. The obese patient is at risk of postoperative complications: difficult airway management, acute respiratory failure following extubation due to atelectasis and airway obstruction, added to morphine overdosing. Optimal management of difficult mask ventilation and intubation, protective ventilation, combined to the reduct...
Source: Presse Medicale - Category: General Medicine Authors: Tags: Presse Med Source Type: research
Conclusions: Our study found that a combination of MPS, SMD, NM and NC permits reliable, accurate and quick preoperative prediction of difficult intubation.
Source: Journal of Anaesthesiology Clinical Pharmacology - Category: Anesthesiology Authors: Source Type: research
We examined whether patients at increased risk for OSA, assessed by the STOP-BANG (snoring, tired during the day, observed stop breathing during sleep, high blood pressure, body mass index more than 35 kg/m, age more than 50 years, neck circumference more than 40 cm, and male gender) questionnaire, had a higher incidence of new-onset postoperative atrial fibrillation after cardiac surgery. Because both postoperative atrial fibrillation and OSA increase resource utilization, we secondarily examined whether patients at increased OSA risk had longer duration of postoperative mechanical ventilation and intensive care unit (ICU...
Source: Anesthesia and Analgesia - Category: Anesthesiology Authors: Tags: Anesth Analg Source Type: research
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