Wednesday, April 18, 2018

HATE YOUR CPAP? Get INSPIRED! New Device Treats Sleep Apnea successfully


INSPIRE is a new therapy for Sleep Apnea.

CPAP  and Oral Appliances have been the first line treatments for mild to moderate sleep apnea and CPAP is the gold standard for severe sleep apnea.

While CPAP is extremely effective only 25% of patients actually utilize t as prescribed and 60% of patients refuse or fail CPAP completely.

Oral Appliances have been the choice of most patients who do not tolerate CPAP but these new studies show that there is a new effective treatment.  Studies have shown that over 90% of patients offered a choice of CPAP or an Oral Appliance chose the Oral Appliance therapy.  Chicago testimonials for Oral Appliance Therapy can be found at:  https://thinkbetterlife.com/category/blogs/

Now that there is a new player and patients have more choices, a very positive development.

Morbidly obese patients are probably still going to need CPAP but just as oral appliances are used with CPAP to lower pressure cotreatment with inspire will probably be possible as well.

Inspire or Hypoglossal nerve stimulation (HNS) therapy is the newest player on the block.

There are three new studies (abstracts below) on the use of Upper Airway Stimulation with the Inspire device.  This is GOD NEWS for patients who HATE CPAP!

North Shore Health System is the first in Chicago to offer Inspire Therapy.
https://www.northshore.org/sleep-center/procedures/inspire-therapy/

While there are risks associated with this therapy, they are low and the risks of untreated sleep apnea are much greater.


Conclusions in Upper Airway Stimulation for Obstructive Sleep Apnea:  5- Year Outcomes. showed Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.  The study showed the responder rate was 63% at 5 years and that there was a 6% rate of serious device-related events related to lead/device adjustments.

The study in  2018 Mar 2. pii: S0196-0709(18)30077-2. doi: 10.1016/j.amjoto.2018.03.003. "Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience.  tShowed that Inspire was more successful than traditional UP3 surgery with 65%  HNS patients achieving an AHI of under 5  ie HNS is  "curative" in the majority of patients. "For select patients, HNS therapy provides excellent objective improvement in outcome measures."





 2018 Mar 1:194599818762383. doi: 10.1177/0194599818762383. [Epub ahead of print]

Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes.

Abstract

Objective To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical trial. Methods From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg="" m="" span="" style="font-size: 0.8461em; line-height: 1.6363em; position: relative; top: -0.5em; vertical-align: baseline;">2
, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 and="" events="" hour="" per="">50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.

KEYWORDS:

cranial nerve; device; device apnea hypopnea index; hypoglossal nerve; implant; long term; obstructive sleep apnea; polysomnogram; quality of life; sleep; sleepiness; surgery; upper airway stimulation
PMID:
 
29582703
 
DOI:
 
10.1177/0194599818762383

Upper Airway Stimulation for Obstructive Sleep Apnea: Results from the ADHERE Registry.

Boon M, et al. Otolaryngol Head Neck Surg. 2018.

Abstract

Objective Upper airway stimulation (UAS) is an alternative treatment option for patients unable to tolerate continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA). Studies support the safety and efficacy of this therapy. The aim of this registry is to collect retrospective and prospective objective and subjective outcome measures across multiple institutions in the United States and Germany. To date, it represents the largest cohort of patients studied with this therapy. Study Design Retrospective and prospective registry study. Setting Ten tertiary care hospitals in the United States and Germany. Subjects and Methods Patients were included who had moderate to severe OSA, were intolerant to CPAP, and were undergoing UAS implantation. Baseline demographic and sleep study data were collected. Objective and subjective treatment outcomes, adverse events, and patient and physician satisfaction were reviewed. Results The registry enrolled 301 patients between October 2016 and September 2017. Mean ± SD AHI decreased from 35.6 ± 15.3 to 10.2 ± 12.9 events per hour ( P < .0001), and Epworth Sleepiness Scale scores decreased from 11.9 ± 5.5 to 7.5 ± 4.7 ( P < .0001) from baseline to the posttitration visit. Patients utilized therapy for 6.5 hours per night. There were low rates of procedure- and device-related complications. Clinical global impression scores demonstrated that the majority of physicians (94%) saw improvement in their patients' symptoms with therapy. The majority of patients (90%) were more satisfied with UAS than CPAP. Conclusions Across a multi-institutional registry, UAS therapy demonstrates significant improvement in subjective and objective OSA outcomes, good therapy adherence, and high patient satisfaction.

PMID

 29557280 [ - as supplied by publisher]


 2018 Mar 2. pii: S0196-0709(18)30077-2. doi: 10.1016/j.amjoto.2018.03.003. [Epub ahead of print]

Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience.




Abstract

OBJECTIVES:

Hypoglossal nerve stimulation (HNS) therapy is an emerging surgical treatment for select patients with obstructive sleep apnea (OSA). This study aims to compare outcomes in patients with moderate to severe OSA who underwent HNS surgery (Inspire Medical Systems) and those who underwent traditional airway reconstructive surgery, specifically uvulopalatopharyngoplasty (UPPP).

METHODS:

Patients who underwent HNS implantation (n = 20), all with moderate to severe OSA, inability to adhere to positive pressure therapy, and compliant with previously published inclusion criteria, were compared to a historical cohort that were intolerant of CPAP with similar inclusion criteria who all underwent UPPP (n = 20) with some also undergoing additional procedures such as septoplasty/turbinate reduction. Data including body mass index (BMI), pre- and post-implant apnea-hypopnea index (AHI) were assessed.

RESULTS:

For patients who underwent HNS, mean preoperative BMI was 28.0. Mean AHI decreased significantly from 38.9 ± 12.5 to 4.5 ± 4.8. All patients achieved an AHI < 20 post implant with 65% (13/20) with an AHI ≤ 5. For patients who underwent traditional airway surgery, mean preoperative BMI was 27.5; mean AHI decreased from 40.3 ± 12.4 to 28.8 ± 25.4.

CONCLUSION:

While both traditional surgery and HNS are effective treatments for patients with moderate to severe OSA with CPAP intolerance, our study demonstrates that HNS is "curative" in normalizing the AHI to <5 excellent="" for="" hns="" improvement="" in="" majority="" measures.="" objective="" of="" outcome="" p="" patients.="" patients="" provides="" select="" the="" therapy="">

KEYWORDS:

Apnea hypopnea index; Hypoglossal nerve stimulation; Obstructive sleep apnea; Upper airway surgery; Uvulopalatopharyngoplasty
PMID:
 
29540289
 
DOI:
 
10.1016/j.amjoto.2018.03.003