Publications by authors named "R Peter Manes"

49 Publications

Adverse Events Associated With Corticosteroid-Eluting Sinus Stents: A MAUDE Database Analysis.

Otolaryngol Head Neck Surg 2021 Apr 13:1945998211006930. Epub 2021 Apr 13.

Division of Otolaryngology, Department of Surgery, School of Medicine, Yale University, New Haven, Connecticut, USA.

Objective: Corticosteroid-eluting stents (CESs) are increasingly used after endoscopic sinus surgery to reduce the need for revision surgery, but their use is not without risks. The objective of this study is to describe adverse events related to CESs.

Study Design: Retrospective cross-sectional study.

Setting: The US Food and Drug Administration's MAUDE database (2011-2020; Manufacturer and User Facility Device Experience).

Methods: The MAUDE database was queried for reports of adverse events involving the use of CESs approved by the Food and Drug Administration, including Propel, Propel Mini, Propel Contour, and Sinuva (Intersect ENT).

Results: There were 28 reported adverse events in total, with all events being related to the Propel family of stents and none related to Sinuva stents. Overall, 22 were categorized as patient-related adverse events and 6 as device-related events. The most common adverse event was related to postoperative infection, accounting for 39% (n = 11) of all complications. Four of these patients developed periorbital cellulitis, and 5 developed a fungal infection. The second-most common adverse event was migration of the stent, representing 21% of all complications (n = 6). Overall, 8 patients (29%) in our cohort required reintervention in the operating room, with subsequent removal of the CES.

Conclusion: The most commonly reported adverse events were postoperative infection, including multiple cases of fungal infection, followed by migration of the stent. An increased awareness of the complications associated with CESs can be used to better inform patients during the consenting process as well as surgeons in their surgical decision making.
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http://dx.doi.org/10.1177/01945998211006930DOI Listing
April 2021

Role and Growth of Independent Medicare-Billing Otolaryngologic Advanced Practice Providers.

Otolaryngol Head Neck Surg 2021 Mar 9:194599821994820. Epub 2021 Mar 9.

Department of Surgery, Division of Otolaryngology, Yale University School of Medicine, New Haven, Connecticut, USA.

Objective: To evaluate the role and growth of independently billing otolaryngology (ORL) advanced practice providers (APPs) within a Medicare population.

Study Design: Retrospective cross-sectional study.

Setting: Medicare Provider Utilization and Payment Data: Physician and Other Supplier Data Files, 2012-2017.

Methods: This retrospective review included data and analysis of independent Medicare-billing ORL APPs. Total sums and medians were gathered for Medicare reimbursements, services performed, number of patients, and unique () codes used, along with geographic and sex distributions.

Results: There has been near-linear growth in number of ORL APPs (13.7% to 18.4% growth per year), with a 115.4% growth from 2012 to 2017. Similarly, total Medicare-allowed reimbursement (2012: $15,568,850; 2017: $35,548,446.8), total number of services performed (2012: 313,676; 2017: 693,693.7), and total number of Medicare fee-for-service (FFS) patients (2012: 108,667; 2017: 238,506) increased. Medians of per APP number of unique codes used, Medicare-allowed reimbursement, number of services performed, and number of Medicare FFS patients have remained constant. There were consistently more female APPs than male APPs (female APP proportion range: 71.3%-76.7%). Compared to ORL physicians, there was a significantly greater proportion of APPs practicing in a rural setting as opposed to urban settings (2017: APP proportion 13.6% vs ORL proportion 8.4%; < .001).

Conclusion: Although their scope of practice has remained constant, independently billing ORL APPs are rapidly increasing in number, which has led to increased Medicare reimbursements, services, and patients. ORL APPs tend to be female and are used more heavily in regions with fewer ORL physicians.
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http://dx.doi.org/10.1177/0194599821994820DOI Listing
March 2021

Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis.

Otolaryngol Head Neck Surg 2021 Feb 2:194599820986581. Epub 2021 Feb 2.

Division of Otolaryngology, Yale University School of Medicine, New Haven, Connecticut, USA.

Posterior nasal nerve (PNN) cryoablation is a novel surgical technique used to address chronic rhinitis. The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to the use of ClariFix, a device designed for office-based cryosurgical ablation of the PNN. A total of 12 adverse events associated with ClariFix from January 2017 to August 2020 were identified and analyzed. The most common adverse events associated with ClariFix PNN cryoablation include epistaxis and nasal swelling. Further studies are needed to clarify whether PNN cryoablation is associated with epistaxis in certain populations.
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http://dx.doi.org/10.1177/0194599820986581DOI Listing
February 2021

Does alleviate tinnitus? A review of the current literature.

Laryngoscope Investig Otolaryngol 2020 Dec 30;5(6):1147-1155. Epub 2020 Oct 30.

Division of Otolaryngology - Head and Neck Surgery, Department of Surgery Yale University School of Medicine New Haven Connecticut USA.

Objectives: Endocannabinoid pathways have been proposed to affect the underlying pathophysiology of tinnitus. The aim of this study is to evaluate the scope and findings of existing literature on the relationship between and cannabinoid pathways and tinnitus.

Methods: We conducted a review of animal, clinical and survey studies investigating the relationship between the use of -derived agents and tinnitus. Using pertinent keywords and MeSH terms on PubMed, relevant studies were identified, yielding four animal studies, two large cross-sectional survey studies, one clinical cross-over study, and one case report.

Results: Animal studies revealed that cannabinoid receptor expression in the cochlear nucleus varied with tinnitus symptomatology and the use of cannabinoid agents either increased or had no effect on tinnitus-related behavior. Survey studies yielded conflicting results between use and tinnitus in the general population. Clinical data is largely lacking, although a small cohort study showed a dose-dependent relationship between tetrahydrocannabinol consumption and frequency of tinnitus episodes in patients receiving treatment for cancer.

Conclusion: While animal studies have revealed that cannabinoid receptors likely have a role in modulating auditory signaling, there is no compelling data either from animal or human studies for the use of cannabinoids to alleviate tinnitus. Further research is necessary to elucidate their precise role to guide development of therapeutic interventions.

Level Of Evidence: NA.
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http://dx.doi.org/10.1002/lio2.479DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752070PMC
December 2020

Characterizing the providers of and reimbursement for chronic migraine chemodenervation among the Medicare population.

Headache 2021 Feb 18;61(2):373-384. Epub 2020 Dec 18.

Division of Otolaryngology, Department of Surgery, Yale University School of Medicine, New Haven, CT, USA.

Objective: To characterize reimbursement trends and providers for chronic migraine (CM) chemodenervation treatment within the Medicare population since the introduction of the migraine-specific CPT code in 2013.

Methods: We describe trends in procedure volume and total allowed charge on cross-sectional data obtained from 2013 to 2018 Medicare Part B National Summary files. We also utilized the 2017 Medicare Provider Utilization and Payment Data to analyze higher volume providers (>10 procedures) of this treatment modality.

Results: The total number of CM chemodenervation treatments rose from 37,863 in 2013 to 135,023 in 2018 in a near-linear pattern (r = 0.999) and total allowed charges rose from ~$5,217,712 to $19,166,160 (r = 0.999). The majority of high-volume providers were neurologists (78.4%; 1060 of 1352), but a substantial proportion were advanced practice providers (APPs) (10.2%; 138 of 1352). Of the physicians, neurologists performed a higher mean number of procedures per physician compared to non-neurologists (59.6 [95% CI: 56.6-62.6] vs. 45.4 [95% CI: 41.0-50.0], p < 0.001). When comparing physicians and APPs, APPs were paid significantly less ($146.5 [95% CI: $145.6-$147.5] vs. $119.7 [95% CI: $117.6-$121.8], p < 0.001). As a percent of the number of total beneficiaries in each state, the percent of Medicare patients receiving ≥1 CM chemodenervation treatment from a high-volume provider in 2017 ranged from 0.024% (24 patients of 98,033 beneficiaries) in Wyoming to 0.135% (997 of 736,521) in Arizona, with six states falling outside of this range.

Conclusion: Chemodenervation is an increasingly popular treatment for CM among neurologists and other providers, but the reason for this increase is unclear. There is substantial geographic variation in its use.
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http://dx.doi.org/10.1111/head.14040DOI Listing
February 2021