I've heard about surgery putting 3 small tubes in throat to open airway. There for elimating the need for a CPap. Where is this sugery done?

EddLngst wrote:

I've heard about surgery putting 3 small tubes in throat to open airway. There for elimating the need for a CPap. Where is this sugery done?

Hi,

I think you are referring to The Pillar Procedure. Involves inserting the equivalent of shirt collar stiffeners into your soft pallat.

Only one study available, carried out by the company that make the stiffeners. Comprised 12 participants with mild apnoea (AHI <15), 2 had the stiffeners removed. Remainder were declared a success after 3 months. No more follow up.

This procedure has FDA approval, primarily for snoring.

Surgery is normally carried out by ENT surgeons who are 'approved' by the company, kinda like a franchise.

I would strongly suggest that you discuss it with your sleep doctor first.

Daniel


_________________
The untreated Sleep Apnoea sufferer died quietly in his sleep.......
Unlike his three passengers who died screaming !!!!!!

(Anon)

Daniel wrote:

EddLngst wrote:

I've heard about surgery putting 3 small tubes in throat to open airway. There for elimating the need for a CPap. Where is this sugery done?

Hi,

I think you are referring to The Pillar Procedure. Involves inserting the equivalent of shirt collar stiffeners into your soft pallat.

Only one study available, carried out by the company that make the stiffeners. Comprised 12 participants with mild apnoea (AHI <15), 2 had the stiffeners removed. Remainder were declared a success after 3 months. No more follow up.

This procedure has FDA approval, primarily for snoring.

Surgery is normally carried out by ENT surgeons who are 'approved' by the company, kinda like a franchise.

I would strongly suggest that you discuss it with your sleep doctor first.

Daniel

Back again,

Since posting I came accross this article which might be of interest:

'For Socially Significant Snoring
A variety of outpatient surgical procedures have undergone evaluation for the treatment of snoring, including laser assisted uvulopalatopharyngoplasty, radiofrequency treatment to the soft palate, injection snoreplasty, and the newest treatment, palatal implants made of polyethylene terephthalate palatal, the Pillar(r) implants.
It's estimated that one in five Americans suffers from habitual snoring. Treatment options have included everything from herbal remedies to dental devices to surgery.

Snoring and obstructive sleep apnea occur when there's a partial collapse of the airway and from vibrations, usually of the soft palate. The latest method of treating habitual snoring is PET {polyethylene terephthalate) implants introduced by a special needle into the soft palate.

Two otolaryngologists — head and neck surgeons - John H. Romanow MD FACS, and Peter. J. Catalano MD FACS, from the Otolaryngology Department, Lahey Clinic, Burlington, MA. have conducted a study on “Efficacy and Safety of Palatal Implants for the Treatment of Socially Significant Snoring.�

Palatial implants are made of braided material and inserted with the needle into three points on the soft palate muscle - the center and one on each side. These serve to stiffen the tissues and reduce vibration. The implants also produce scarring which serves to further stiffen the palatial tissue.

25 patients participated in the study, all classed by the bed partner as habitual snorers. Those suffering from OSA were excluded from the test as it was strictly to evaluate the use of the procedure to reduce snoring.

These people were assessed again at one and three month periods. All tolerated the procedure well and there were no complications. Bed partners found that the loudness of the snoring decreased, as did excessive daytime sleepiness.

In conclusion, Drs. Romanow and Catalano have deemed the Pillar Procedure a safe and effective method for treating habitual snoring. The palatal implants have received FDA clearance for treating both snoring and mild to moderate OSA. However, it was decided that further work and testing was needed to find out the role of the implants in the treatment of obstructive sleep apnea.'


I think that this underlines the big question mark over this procedure as a treatment for OSA.
In undergoing this form of treatment for snoring alone I believe it is extremely important that the patient should undergo a polysomnogram first to determine whether or not they have sleep apnoea. Little point in treating/curing snoring if it happens to be a symptom of an underlying possibly life threatening sleep disorder.

Daniel


_________________
The untreated Sleep Apnoea sufferer died quietly in his sleep.......
Unlike his three passengers who died screaming !!!!!!

(Anon)

I agree absolutely with Daniel on this:

Quote:

In undergoing this form of treatment for snoring alone I believe it is extremely important that the patient should undergo a polysomnogram first to determine whether or not they have sleep apnoea. Little point in treating/curing snoring if it happens to be a symptom of an underlying possibly life threatening sleep disorder.

Edd, there are many, many discussion topics about the Pillar Implants procedure on the Talkaboutsleep message board.  The dental sleep medicine forum on TAS  is a good place to read actual experiences of several people who have had the Pillar Procedure done.  Several of them are having very good success treating their OSA --  proven by polysomnogaph sleep studies both before and after.  However, most have to use two methods to deal with OSA - Pillar procedure PLUS a dental device (usually the TAP II device.)

The posters nicknamed PaulY, Sleepy Stoboy, and RickRed on that forum would probably be able to give you the most useful advice about how to find the right doctors, to see if either or both of those things would help you.  I think those posters would all tell you that a PSG sleep study before AND another one at some point AFTER are of the utmost importance.   As Daniel points out, eliminating "snoring" only...that's not good enough.  You need to be sure that any procedure or appliance you use actually takes care of the health-threatening problem  -- OSA -- and doesn't just cover up a symptom.

Here's a link that will get you to more links.       Check out the discussion topics under "Pillar, Tap", and do visit the link to the Dental Sleep Medicine forum on TAS.

LINKS to surgery, turbinates, Pillar, TAP experiences

I've also been reserching the Pillar and got this from Restore.

The Pillar® Procedure: OSA Clinical Research Synopsis
• Over 200 patients enrolled in OSA studies at multiple centers
• In clinical studies that have been completed, 80% or more of patients experienced reductions in AHI and as high as
63% of patients experienced reductions in AHI to = 10
• Reported complication rates during commercial use are approximately 1%
Clinical Research Summary OSA patients. N=201
Year Publications Investigator N* Results

2004
Accepted for Publication
Otolaryngology-HNS
(5/05)1
M. Friedman, MD 125
• 34% of patients experienced an AHI reduction >50% to an
AHI of <20
• 88% of patients had an improvement in VAS
• 64% of patients had an improvement in ESS

2004
Submitted to
Otolaryngology-HNS
(4/05)2
S. Nordgård, MD 30
• 80% of patients experienced a reduction in AHI at 90 days
• 48% of these patients experienced an AHI reduction to = 10
• ESS and VAS decreased by 43% and 49%, respectively

2004
Submitted to Annals of
Otology, Rhinology &
Laryngology (7/05)3
G. Hein, MD 16
• 81% of patients experienced a reduction in AHI at 90 days
• 63% of these patients experienced an AHI reduction to = 10
• ESS and VAS decreased by 36% and 43%, respectively

2004
Abstract submitted to
Otolaryngology-HNS
(1/05)4
R. Walker, MD 30
• 72% of patients experienced a reduction in AHI at 90 days
• ESS and VAS decreased by 37% and 45%, respectively

2005
Submitted to
Otolaryngology-HNS
(7/05)5
S. Nordgård, MD 26
• 81% of patients experienced a reduction in AHI at 1 year
• 58% of patients experienced an AHI reduction to = 10
• ESS and VAS decreased by 35% and 45%, respectively
*Patients may be represented more than once in this table.
As part of our continuing efforts, the following abstracts have been accepted for presentation at the September 2005 Annual
Meeting of the AAO-HNSF:
• Regina P. Walker, MD, et. al., “Palatal Implants: A New Approach for the Treatment of Obstructive Sleep Apnea,�
oral presentation
• Regina P. Walker, MD, et. al., “Pillar Palatal Implants for Obstructive Sleep Apnea: Patient Selection Optimization,�
poster presentation
• Brit Kari Stene, MD, “Long Term Follow-Up of Patients Treated for Obstructive Sleep Apnea by Palatal Implants,�
oral presentation
1Friedman M, Vidyasagar R, Bliznikas D. Patient Selection and Effi cacy of the Pillar Implant Technique for Treatment of Snoring and Obstructive Sleep
Apnea/Hypopnea Syndrome.
2Nordgård S, Stene B, Skjøstad K. Soft Palate Implants for the Treatment of Mild to Moderate Obstructive Sleep Apnea.
3Hein G, Verse T, Stuck BA, Hörmann K, Maurer JT. The Pillar Palatal Implant System: First Results in OSA Patients.
4Walker RP, Levine HL, Terris DJ, Hopp ML, Greene D, Pang KP. Palatal Implants: A New Approach for the Treatment of Obstructive Sleep Apnea.
5Nordgård S, Hein G, Stene B, Skjøstad K, Maurer JT. Long –Term Follow-up of Palatal Implants for the Treatment of Obstructive Sleep Apnea.

The Pillar® Procedure: Snoring Clinical Research Synopsis
• Over 130 patients enrolled in snoring studies at multiple centers
• The results of clinical studies on the use of the Pillar Procedure to treat patients suffering from socially disruptive
snoring have been published, accepted or submitted for publication in four different journals
• In clinical studies that have been completed, bed partner satisfaction ranged from 67-100%
Clinical Research Summary Snoring Patients, N=131
Year Publications Investigator N* Results
2001
Archives of Otolaryngology
(6/04)1 W. Wei, MD 12
• Snoring intensity decreased 39%
• Bed partner satisfaction 67%
2002 Acta-Otolaryngologica (10/04)2 S. Nordgård, MD 35
• Snoring intensity decreased 51%
• Bed partner satisfaction 86%
2002 Otolaryngology-HNS (1/05)3 J. Maurer, MD 15
• Snoring intensity decreased 66%
• Bed partner satisfaction 100%
2002
European Archives of Oto-Rhino-
Laryngology (8/04)4 T. Kühnel, MD 106
• Snoring intensity decreased 45%
• Bed partner satisfaction 72%
2003
Accepted for Publication by
Otolaryngology-HNS (6/05)5 S. Nordgård, MD 35
• Snoring intensity decreased 32%
• Bed partner satisfaction 71%
2003
Accepted for Publication by
Otolaryngology-HNS (7/05)6 J. Maurer, MD 40
• Snoring intensity decreased 32%
• Bed partner satisfaction 90%
2004
Submitted to Otolaryngology-
HNS (3/05)7 P. Catalano, MD 25
• Snoring intensity decreased 48%
• Bed partner satisfaction 90%
*Patients may be represented more than once in this table.
The following abstracts have been accepted for presentation at the September 2005 Annual Meeting of the AAO-HNSF:
• Ståle Nordgård, MD, PhD, Ketil W. Skjøstad, MD, “Consequences of Increased Rigidity in Palatal Implants for
Treatment of Snoring,� oral presentation
• Peter J. Catalano, MD, John H. Romanow, MD, “Effi cacy and Safety of Palatal Implants for the Treatment of Socially
Signifi cant Snoring,� oral presentation
1Ho W, Wei W, Chung K. Managing Disturbing Snoring With Palatal Implants: A Pilot Study. Arch Otolaryngol Head Neck Surg. 2004; 130:753-758.
2Nordgård S, Wormdal K, Bugten V, Stene B, Skjøstad K. Palatal Implants: A New Method for the Treatment of Snoring. Acta Otolaryngol
2004; 124:1-7. 3Maurer JT, Verse T, Stuck BA, Hörmann K, Hein G. Palatal implants for primary snoring: Short-term results of a new minimally invasive surgical technique.
Otolaryngology-HNS, 2005; 132:125-31.
4 Kühnel T, Hein G, Hohenhorst W, Maurer JT, “Soft Palate Implants: A New Option for Treating Habitual Snoring,� European Archives of Oto-Rhino
Laryngology 2005; 262:277-280.
5Nordgård S, Wormdal K,, Stene B, Skjøstad K. Palatal Implants for the Treatment of Snoring: Long–term Results.
6Maurer JT, Verse T, Stuck BA, Hörmann K, Hein G. Long–term Results of the Pillar® Palatal Implant System for Primary Snoring.
7Romanow J, Catalano P, Effi cacy and Safety of Palatal Implants for the Treatment of Socially Signifi cant Snoring.
LRF-271 8/05

mikeg wrote:

I've also been reserching the Pillar and got this from Restore.

The Pillar® Procedure: OSA Clinical Research Synopsis
• Over 200 patients enrolled in OSA studies at multiple centers
• In clinical studies that have been completed, 80% or more of patients experienced reductions in AHI and as high as
63% of patients experienced reductions in AHI to = 10
• Reported complication rates during commercial use are approximately 1%
Clinical Research Summary OSA patients. N=201
Year Publications Investigator N* Results

2004
Accepted for Publication
Otolaryngology-HNS
(5/05)1
M. Friedman, MD 125
• 34% of patients experienced an AHI reduction >50% to an
AHI of <20
• 88% of patients had an improvement in VAS
• 64% of patients had an improvement in ESS

2004
Submitted to
Otolaryngology-HNS
(4/05)2
S. Nordgård, MD 30
• 80% of patients experienced a reduction in AHI at 90 days
• 48% of these patients experienced an AHI reduction to = 10
• ESS and VAS decreased by 43% and 49%, respectively

2004
Submitted to Annals of
Otology, Rhinology &
Laryngology (7/05)3
G. Hein, MD 16
• 81% of patients experienced a reduction in AHI at 90 days
• 63% of these patients experienced an AHI reduction to = 10
• ESS and VAS decreased by 36% and 43%, respectively

2004
Abstract submitted to
Otolaryngology-HNS
(1/05)4
R. Walker, MD 30
• 72% of patients experienced a reduction in AHI at 90 days
• ESS and VAS decreased by 37% and 45%, respectively

2005
Submitted to
Otolaryngology-HNS
(7/05)5
S. Nordgård, MD 26
• 81% of patients experienced a reduction in AHI at 1 year
• 58% of patients experienced an AHI reduction to = 10
• ESS and VAS decreased by 35% and 45%, respectively
*Patients may be represented more than once in this table.
As part of our continuing efforts, the following abstracts have been accepted for presentation at the September 2005 Annual
Meeting of the AAO-HNSF:
• Regina P. Walker, MD, et. al., “Palatal Implants: A New Approach for the Treatment of Obstructive Sleep Apnea,�
oral presentation
• Regina P. Walker, MD, et. al., “Pillar Palatal Implants for Obstructive Sleep Apnea: Patient Selection Optimization,�
poster presentation
• Brit Kari Stene, MD, “Long Term Follow-Up of Patients Treated for Obstructive Sleep Apnea by Palatal Implants,�
oral presentation
1Friedman M, Vidyasagar R, Bliznikas D. Patient Selection and Effi cacy of the Pillar Implant Technique for Treatment of Snoring and Obstructive Sleep
Apnea/Hypopnea Syndrome.
2Nordgård S, Stene B, Skjøstad K. Soft Palate Implants for the Treatment of Mild to Moderate Obstructive Sleep Apnea.
3Hein G, Verse T, Stuck BA, Hörmann K, Maurer JT. The Pillar Palatal Implant System: First Results in OSA Patients.
4Walker RP, Levine HL, Terris DJ, Hopp ML, Greene D, Pang KP. Palatal Implants: A New Approach for the Treatment of Obstructive Sleep Apnea.
5Nordgård S, Hein G, Stene B, Skjøstad K, Maurer JT. Long –Term Follow-up of Palatal Implants for the Treatment of Obstructive Sleep Apnea.

The Pillar® Procedure: Snoring Clinical Research Synopsis
• Over 130 patients enrolled in snoring studies at multiple centers
• The results of clinical studies on the use of the Pillar Procedure to treat patients suffering from socially disruptive
snoring have been published, accepted or submitted for publication in four different journals
• In clinical studies that have been completed, bed partner satisfaction ranged from 67-100%
Clinical Research Summary Snoring Patients, N=131
Year Publications Investigator N* Results
2001
Archives of Otolaryngology
(6/04)1 W. Wei, MD 12
• Snoring intensity decreased 39%
• Bed partner satisfaction 67%
2002 Acta-Otolaryngologica (10/04)2 S. Nordgård, MD 35
• Snoring intensity decreased 51%
• Bed partner satisfaction 86%
2002 Otolaryngology-HNS (1/05)3 J. Maurer, MD 15
• Snoring intensity decreased 66%
• Bed partner satisfaction 100%
2002
European Archives of Oto-Rhino-
Laryngology (8/04)4 T. Kühnel, MD 106
• Snoring intensity decreased 45%
• Bed partner satisfaction 72%
2003
Accepted for Publication by
Otolaryngology-HNS (6/05)5 S. Nordgård, MD 35
• Snoring intensity decreased 32%
• Bed partner satisfaction 71%
2003
Accepted for Publication by
Otolaryngology-HNS (7/05)6 J. Maurer, MD 40
• Snoring intensity decreased 32%
• Bed partner satisfaction 90%
2004
Submitted to Otolaryngology-
HNS (3/05)7 P. Catalano, MD 25
• Snoring intensity decreased 48%
• Bed partner satisfaction 90%
*Patients may be represented more than once in this table.
The following abstracts have been accepted for presentation at the September 2005 Annual Meeting of the AAO-HNSF:
• Ståle Nordgård, MD, PhD, Ketil W. Skjøstad, MD, “Consequences of Increased Rigidity in Palatal Implants for
Treatment of Snoring,� oral presentation
• Peter J. Catalano, MD, John H. Romanow, MD, “Effi cacy and Safety of Palatal Implants for the Treatment of Socially
Signifi cant Snoring,� oral presentation
1Ho W, Wei W, Chung K. Managing Disturbing Snoring With Palatal Implants: A Pilot Study. Arch Otolaryngol Head Neck Surg. 2004; 130:753-758.
2Nordgård S, Wormdal K, Bugten V, Stene B, Skjøstad K. Palatal Implants: A New Method for the Treatment of Snoring. Acta Otolaryngol
2004; 124:1-7. 3Maurer JT, Verse T, Stuck BA, Hörmann K, Hein G. Palatal implants for primary snoring: Short-term results of a new minimally invasive surgical technique.
Otolaryngology-HNS, 2005; 132:125-31.
4 Kühnel T, Hein G, Hohenhorst W, Maurer JT, “Soft Palate Implants: A New Option for Treating Habitual Snoring,� European Archives of Oto-Rhino
Laryngology 2005; 262:277-280.
5Nordgård S, Wormdal K,, Stene B, Skjøstad K. Palatal Implants for the Treatment of Snoring: Long–term Results.
6Maurer JT, Verse T, Stuck BA, Hörmann K, Hein G. Long–term Results of the Pillar® Palatal Implant System for Primary Snoring.
7Romanow J, Catalano P, Effi cacy and Safety of Palatal Implants for the Treatment of Socially Signifi cant Snoring.
LRF-271 8/05

Hi Mikeg,

Pretty long posting.
I notice that the information has come from Restore, who actually make the implants and the insertion device, so on that basis I must say that the results posted must be questionable, as there is a major financial interest in portraying a supposedly first line treatment that works. While they have been submitted, they are not peer reviewed and have not been picked up by any of the online journals.

In all cases quoted there is only a percentage improvement mentioned.......67%, 88%, 72% bed partner approval, but what are these percentages of ? At no stage are original AHI or BMI mentioned. These figures actually tell us bugger all.

The reduction of AHI to below 20.........as its not below 15 it could be as high as 19 and still represents moderate apnoea which will require cpap.

There is also the problem that all results are pitched at 90 days post procedure. We must remember that in most cases the dreaded UPPP looks pretty good after 90 days.

My earlier posting represents a peer reviewed study, the conclusion of which is quite specific.

In conclusion, Drs. Romanow and Catalano have deemed the Pillar Procedure a safe and effective method for treating habitual snoring. The palatal implants have received FDA clearance for treating both snoring and mild to moderate OSA. However, it was decided that further work and testing was needed to find out the role of the implants in the treatment of obstructive sleep apnea.'

I have also recently received a copy of Restores briefing document on the Pillar Procedure, which verges on the hard sell. Figures quoted here are for 36 cases, a grouped breakdown as follows:

No.       Baseline AHI     90 day AHI  
1            13                         4.2
2            24                        16
3            15                         7.7
4            17                         9.6
5            20                         3.9
6            23                        15
7            20                         5.4
8            11.1                     10.3
9            18.5                      5.9
10          11                         0.3
11          12                         2.3
12          13                        9.6
13          13.4                     8.7

These figures go on and on (I'm not great at typing), but out of 36 cases there are only 15 cases with a baseline AHI above 15 and of those 15 there are only 5 cases with a baseline AHI above 20 and the highest AHI is 26.1. Not a single severe apnoea sufferer. The most impressive 90 day improvements were recorded in those with a baseline AHI of 15 and below.

Restores own figures are at best inconclusive, but do indicate a 90 day improvement in what might be termed snorers as distinct from OSA sufferers.

Restore are embarking on a big sales drive in Europe, but seem to be targetting ENT surgeons as distinct from sleep laboratories.

As you can guess, I am against new unproven procedures until there are long term positive results. In particular procedures, such as Pillar, that are being marketed as (quote from Restore) 'A simple, effective, first line treatment for your OSA patients'...........I don't know where they are coming from, but it certainly (based on their own sales literature) could not be termed 'first line'.

Daniel


_________________
The untreated Sleep Apnoea sufferer died quietly in his sleep.......
Unlike his three passengers who died screaming !!!!!!

(Anon)