- Email: [email protected]
Palatal implants for snoring and sleep apnea
Operative Techniques in Otolaryngology (2006) 17, 238-241
Palatal implants for snoring and sleep apnea Regina Paloyan Walker, MD From Hinsdale Hospital, Hinsdale, Illinois. KEYWORDS Palatal implants; Snoring; Obstructive sleep apnea
Soft palate implants are a new office-based procedure for snoring and sleep apnea. A single session is needed to insert 3 implants into the soft palate using only local anesthesia. The implants have been shown to reduce snoring. A less collapsible airway occurs as a result of the implants, and this change has been demonstrated to reduce obstructive airway events. The procedure will be described in detail. The current literature is briefly reviewed. © 2006 Elsevier Inc. All rights reserved.
Soft palate implants are the “newcomers to the block” in the snoring and obstructive sleep apnea (OSA) surgical community. Beginning in the 1950s, focus has been placed on the soft palate as the main source of snoring and a cause of obstruction in the upper airway. Over the past 50 years, procedures have been developed to reduce the volume of this tissue. Palatal implants are a novel approach to the treatment of sleep-disordered breathing: 3 braided polyester filaments are placed into the muscle layer of the palate under local anesthesia in the office. This treatment method has reduced or eliminated snoring and improved obstructed breathing.1-10 Implants work by stiffening the airway and reducing the pharyngeal closing pressure.11,12 The airway becomes less collapsible after implants are placed, and more suction is required to collapse the pharynx. A normal airway in the sleeping state collapses at ⫺13 cm water. After palatal implants are placed, airway collapse requires ⫺17 cm water, which is comparable to the ⫺18 cm water required after uvulopalatopharyngoplasty.11 Initial studies also showed that the optimum placement of the implants is at the junction of the hard and soft palate. This area is the “leading edge” where the palatal vibration begins. By placing the implants close together and high in the soft palate, the initiation of the vibration is dampened.
adults. The only absolute requirement for implants is that the patient has 25 mm of soft palate tissue available for placing implants. After a uvulopalatopharyngoplasty or laser-assisted uvulopalatoplasty, some patients may not have enough length to the remaining tissue to receive implants. Patients with no prior treatment rarely have insufficient soft palate tissue. Patient selection remains critical in the success of all palatal procedures. Optimal implant candidates are patients with the following characteristics: (1) Mallampati airway class I or II, (2) patent nasal airway, and (3) uvula that is reasonable in length. These are general guidelines for both patients with snoring and OSA. In patients with OSA, the success rate was significantly higher in patients classified as having Mallampati class I and II versus III and IV.6,10 It seems intuitive that the optimal responders to a palatal procedure would be patients who appear to have a significant palatal component to their snoring or OSA. If a patient has a Mallampati class III or IV, implants can be performed but may need to be combined with other procedures, which address the base of tongue region. Currently, palatal implants are being performed on patients with mild-to-moderate OSA. Studies are underway to assess the role of implants in patients who are current users of continuous positive airway pressure, in combination with other procedures, and in patients diagnosed with severe apnea.
Preoperative evaluation Soft palate implants are currently Food and Drug Administration approved for the treatment of snoring and OSA in
Technique
Address reprint requests and correspondence: Regina Paloyan Walker, MD, 40 S. Clay Street, Suite 135 West, Hinsdale, IL 60521. E-mail address: [email protected].
The procedure is performed in the office using local anesthesia. The Pillar implant system (Restore Medical, Inc, St. Paul, MN) consists of 3 preloaded delivery tools. Each delivery tool contains one braided polyester filament, which
1043-1810/$ -see front matter © 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.otot.2006.10.001
Walker
Palatal Implants for Snoring and Sleep Apnea
Figure 1 Delivery handpiece of the Pillar implant system. Full insertion marker, halfway depth marker, and needle tip marker are shown.
measures 18 mm in length and has a diameter of 1.8 mm (Figure 1). Each patient receives an oral broad-spectrum antibiotic 1 hour before the procedure and 6-8 hours after implant placement. Just before placing the local anesthetic, the patient is
239 instructed to gargle with an antiseptic oral rinse for one minute. Topical anesthetic spray is used to begin to anesthetize the area to be treated. The treatment area is then infiltrated with approximately 2 mL of a mixture of 1% lidocaine with epinephrine (1:100,000). A nasal decongestant spray is applied to both nasal passages. Once the local anesthetic has taken effect, the 3 implants are placed at the junction of the hard and soft palate, which is palpated with a wooden tongue blade. The midline implant is placed first (Figure 2). The needle tip is introduced through the mucosa and into the muscle. In the midline, especially, the tissue is very fibrous, and it requires pressure and even a “rocking motion” to introduce the needle tip. Once the fibrous layer is penetrated, the needle advances quickly. The needle is advanced with an arcing motion to the full insertion depth marker. The needle tip can be moved side to side to confirm the location of the tip. If the placement is optimal, the delivery tool slider can be unlocked by applying downward pressure to the lock, just below the slider. Deployment of the implant begins by advancing the slider. When the halfway mark is reached, there should be a click. In addition, the slider position can be viewed on the side of the delivery tool. The needle is withdrawn until the halfway depth marker is visible on the needle. The slider is advanced completely until the full deployment position. The needle is removed after the insertion path by moving the handle in an arcing fashion (Figure 3). The process is repeated with the next 2 implants. The implants should be placed 2-mm apart (Figure 4). The needle, which measures approximately 2 mm, can be used as a gauge to estimate the distance between the implants. After placement of all 3 implants, the soft palate is examined. The implants should not be visible at anytime during insertion, in the insertion site when withdrawing the needle, or through the mucosa. Next, a flexible nasopharyn-
Figure 2 Pillar implant handpiece is entering the soft palate, just below the hard palate. The needle follows the arc of the palate as it passes into the muscle. The needle is passed until the full insertion marker is reached.
240
Operative Techniques in Otolaryngology, Vol 17, No 4, December 2006
goscope is passed, and the dorsal surface of the soft palate is examined. An indirect mirror examination of the nasopharynx is an alternative method to examine the nasopharynx. If an implant is exposed, it must be removed. At this point, the implant is not adherent to tissue and is easily removed. A hemostat is the best instrument to grasp the implant securely and remove it without event. The patient is observed for 10 minutes and then discharged to home. Patients are reminded to take their second dose of the chosen antibiotic. Plain acetaminophen and anesthetic lozenges are recommended for pain relief. Rarely, a patient may require a narcotic to control the pain. The pain is typically most severe at 12 hours after the procedure and is usually completely resolved in 48-72 hours. After the procedure, a soft diet and oral rinses are recommended for 3 days. The improvement in snoring and breathing can take a month or more to develop, so patients are seen 4-6 weeks after the procedure. If no obvious improvement has occurred, it is prudent to wait at least 4 months after the procedure before considering additional surgical treatment.
Complications Partial extrusions are the most common complication noted after palatal implants. The partial extrusion rate varies considerably depending on physician experience. The first study showed an extrusion rate of 16.7%.1 With experience, the extrusion rates have decreased to approximately 3%.6 Most physicians become proficient after performing 5 procedures. Implants can partially extrude at any point, but, in general, implants extrude within 1-3 months after the procedure. In most circumstances, the implant can be removed in the office by applying local anesthesia and then a sturdy hemostat is used to remove the implant. The implants may
Figure 4 The 3 implants are placed parallel to each other. The implants should be 2 mm (or one needle width) apart.
be tightly bound to the tissue, and a strong tug may be necessary.
Conclusion The Pillar implant system is a novel and effective treatment for snoring and OSA in carefully chosen patients. This office procedure is quick, well tolerated, and has a low complication rate.
References
Figure 3 Sagittal view of the implant in the muscle layer of the soft palate. Note that the implant is located just below the junction of the hard and soft palate.
1. Ho W, Wei W, Chung K: Managing disturbing snoring with palatal implants: A pilot study. Arch Otolaryngol Head Neck Surg 130:753758, 2004 2. Nordgard S, Wormdal K, Bugten V, et al: Palatal implants: A new method for the treatment of snoring. Acta Otolaryngol 124:970-975, 2004 3. Maurer J, Verse T, Stuck B, et al: Palatal implants for primary snoring: Short-term results of a new minimally invasive surgical technique. Otolaryngol Head Neck Surg 132:125-131, 2005 4. Kuhnel T, Hein G, Hohenhorst W, et al: Soft palate implants: A new option for treating habitual snoring. Eur Arch Otorhinolaryngol 262: 277-280, 2005 5. Maurer J, Hein G, Verse T, et al: Long-term results of palatal implants for primary snoring. Otolaryngol Head Neck Surg 133: 573-578, 2005 6. Friedman M, Vidyasagar R, Bliznikas D, et al: Patient selection and efficacy of pillar implant technique for treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg 134:187-196, 2006
Walker
Palatal Implants for Snoring and Sleep Apnea
7. Nordgard S, Stene B, Skjostad K, et al: Palatal implants for the treatment of snoring: Long- term results. Otolaryngol Head Neck Surg 134:558-564, 2006 8. Romanow J, Catalano P: Initial US: Pilot study: Palatal implants for the treatment of snoring. Otolaryngol Head Neck Surg 134:551-557, 2006 9. Nordgard S, Stene B, Skjostad K: Soft palate implants for the treatment of mild to moderate obstructive sleep apnea. Otolaryngol Head Neck Surg 134:565-570, 2006
241 10. Walker R, Levine H, Hopp M, et al: Palatal implants: A new approach for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg 135:549-554, 2006 11. Huang Y, White D, Malhotra A: The impact of anatomic manipulations on pharyngeal collapse. Chest 128:1324-1330, 2005 12. Skjostad K, Stene B, Nordgard S: Consequences of increased rigidity in palatal implants for snoring: A randomized controlled study. Otolaryngol Head Neck Surg 134:63-66, 2006
Palatal implants for snoring and sleep apnea Regina Paloyan Walker, MD From Hinsdale Hospital, Hinsdale, Illinois. KEYWORDS Palatal implants; Snoring; Obstructive sleep apnea
Soft palate implants are a new office-based procedure for snoring and sleep apnea. A single session is needed to insert 3 implants into the soft palate using only local anesthesia. The implants have been shown to reduce snoring. A less collapsible airway occurs as a result of the implants, and this change has been demonstrated to reduce obstructive airway events. The procedure will be described in detail. The current literature is briefly reviewed. © 2006 Elsevier Inc. All rights reserved.
Soft palate implants are the “newcomers to the block” in the snoring and obstructive sleep apnea (OSA) surgical community. Beginning in the 1950s, focus has been placed on the soft palate as the main source of snoring and a cause of obstruction in the upper airway. Over the past 50 years, procedures have been developed to reduce the volume of this tissue. Palatal implants are a novel approach to the treatment of sleep-disordered breathing: 3 braided polyester filaments are placed into the muscle layer of the palate under local anesthesia in the office. This treatment method has reduced or eliminated snoring and improved obstructed breathing.1-10 Implants work by stiffening the airway and reducing the pharyngeal closing pressure.11,12 The airway becomes less collapsible after implants are placed, and more suction is required to collapse the pharynx. A normal airway in the sleeping state collapses at ⫺13 cm water. After palatal implants are placed, airway collapse requires ⫺17 cm water, which is comparable to the ⫺18 cm water required after uvulopalatopharyngoplasty.11 Initial studies also showed that the optimum placement of the implants is at the junction of the hard and soft palate. This area is the “leading edge” where the palatal vibration begins. By placing the implants close together and high in the soft palate, the initiation of the vibration is dampened.
adults. The only absolute requirement for implants is that the patient has 25 mm of soft palate tissue available for placing implants. After a uvulopalatopharyngoplasty or laser-assisted uvulopalatoplasty, some patients may not have enough length to the remaining tissue to receive implants. Patients with no prior treatment rarely have insufficient soft palate tissue. Patient selection remains critical in the success of all palatal procedures. Optimal implant candidates are patients with the following characteristics: (1) Mallampati airway class I or II, (2) patent nasal airway, and (3) uvula that is reasonable in length. These are general guidelines for both patients with snoring and OSA. In patients with OSA, the success rate was significantly higher in patients classified as having Mallampati class I and II versus III and IV.6,10 It seems intuitive that the optimal responders to a palatal procedure would be patients who appear to have a significant palatal component to their snoring or OSA. If a patient has a Mallampati class III or IV, implants can be performed but may need to be combined with other procedures, which address the base of tongue region. Currently, palatal implants are being performed on patients with mild-to-moderate OSA. Studies are underway to assess the role of implants in patients who are current users of continuous positive airway pressure, in combination with other procedures, and in patients diagnosed with severe apnea.
Preoperative evaluation Soft palate implants are currently Food and Drug Administration approved for the treatment of snoring and OSA in
Technique
Address reprint requests and correspondence: Regina Paloyan Walker, MD, 40 S. Clay Street, Suite 135 West, Hinsdale, IL 60521. E-mail address: [email protected].
The procedure is performed in the office using local anesthesia. The Pillar implant system (Restore Medical, Inc, St. Paul, MN) consists of 3 preloaded delivery tools. Each delivery tool contains one braided polyester filament, which
1043-1810/$ -see front matter © 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.otot.2006.10.001
Walker
Palatal Implants for Snoring and Sleep Apnea
Figure 1 Delivery handpiece of the Pillar implant system. Full insertion marker, halfway depth marker, and needle tip marker are shown.
measures 18 mm in length and has a diameter of 1.8 mm (Figure 1). Each patient receives an oral broad-spectrum antibiotic 1 hour before the procedure and 6-8 hours after implant placement. Just before placing the local anesthetic, the patient is
239 instructed to gargle with an antiseptic oral rinse for one minute. Topical anesthetic spray is used to begin to anesthetize the area to be treated. The treatment area is then infiltrated with approximately 2 mL of a mixture of 1% lidocaine with epinephrine (1:100,000). A nasal decongestant spray is applied to both nasal passages. Once the local anesthetic has taken effect, the 3 implants are placed at the junction of the hard and soft palate, which is palpated with a wooden tongue blade. The midline implant is placed first (Figure 2). The needle tip is introduced through the mucosa and into the muscle. In the midline, especially, the tissue is very fibrous, and it requires pressure and even a “rocking motion” to introduce the needle tip. Once the fibrous layer is penetrated, the needle advances quickly. The needle is advanced with an arcing motion to the full insertion depth marker. The needle tip can be moved side to side to confirm the location of the tip. If the placement is optimal, the delivery tool slider can be unlocked by applying downward pressure to the lock, just below the slider. Deployment of the implant begins by advancing the slider. When the halfway mark is reached, there should be a click. In addition, the slider position can be viewed on the side of the delivery tool. The needle is withdrawn until the halfway depth marker is visible on the needle. The slider is advanced completely until the full deployment position. The needle is removed after the insertion path by moving the handle in an arcing fashion (Figure 3). The process is repeated with the next 2 implants. The implants should be placed 2-mm apart (Figure 4). The needle, which measures approximately 2 mm, can be used as a gauge to estimate the distance between the implants. After placement of all 3 implants, the soft palate is examined. The implants should not be visible at anytime during insertion, in the insertion site when withdrawing the needle, or through the mucosa. Next, a flexible nasopharyn-
Figure 2 Pillar implant handpiece is entering the soft palate, just below the hard palate. The needle follows the arc of the palate as it passes into the muscle. The needle is passed until the full insertion marker is reached.
240
Operative Techniques in Otolaryngology, Vol 17, No 4, December 2006
goscope is passed, and the dorsal surface of the soft palate is examined. An indirect mirror examination of the nasopharynx is an alternative method to examine the nasopharynx. If an implant is exposed, it must be removed. At this point, the implant is not adherent to tissue and is easily removed. A hemostat is the best instrument to grasp the implant securely and remove it without event. The patient is observed for 10 minutes and then discharged to home. Patients are reminded to take their second dose of the chosen antibiotic. Plain acetaminophen and anesthetic lozenges are recommended for pain relief. Rarely, a patient may require a narcotic to control the pain. The pain is typically most severe at 12 hours after the procedure and is usually completely resolved in 48-72 hours. After the procedure, a soft diet and oral rinses are recommended for 3 days. The improvement in snoring and breathing can take a month or more to develop, so patients are seen 4-6 weeks after the procedure. If no obvious improvement has occurred, it is prudent to wait at least 4 months after the procedure before considering additional surgical treatment.
Complications Partial extrusions are the most common complication noted after palatal implants. The partial extrusion rate varies considerably depending on physician experience. The first study showed an extrusion rate of 16.7%.1 With experience, the extrusion rates have decreased to approximately 3%.6 Most physicians become proficient after performing 5 procedures. Implants can partially extrude at any point, but, in general, implants extrude within 1-3 months after the procedure. In most circumstances, the implant can be removed in the office by applying local anesthesia and then a sturdy hemostat is used to remove the implant. The implants may
Figure 4 The 3 implants are placed parallel to each other. The implants should be 2 mm (or one needle width) apart.
be tightly bound to the tissue, and a strong tug may be necessary.
Conclusion The Pillar implant system is a novel and effective treatment for snoring and OSA in carefully chosen patients. This office procedure is quick, well tolerated, and has a low complication rate.
References
Figure 3 Sagittal view of the implant in the muscle layer of the soft palate. Note that the implant is located just below the junction of the hard and soft palate.
1. Ho W, Wei W, Chung K: Managing disturbing snoring with palatal implants: A pilot study. Arch Otolaryngol Head Neck Surg 130:753758, 2004 2. Nordgard S, Wormdal K, Bugten V, et al: Palatal implants: A new method for the treatment of snoring. Acta Otolaryngol 124:970-975, 2004 3. Maurer J, Verse T, Stuck B, et al: Palatal implants for primary snoring: Short-term results of a new minimally invasive surgical technique. Otolaryngol Head Neck Surg 132:125-131, 2005 4. Kuhnel T, Hein G, Hohenhorst W, et al: Soft palate implants: A new option for treating habitual snoring. Eur Arch Otorhinolaryngol 262: 277-280, 2005 5. Maurer J, Hein G, Verse T, et al: Long-term results of palatal implants for primary snoring. Otolaryngol Head Neck Surg 133: 573-578, 2005 6. Friedman M, Vidyasagar R, Bliznikas D, et al: Patient selection and efficacy of pillar implant technique for treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg 134:187-196, 2006
Walker
Palatal Implants for Snoring and Sleep Apnea
7. Nordgard S, Stene B, Skjostad K, et al: Palatal implants for the treatment of snoring: Long- term results. Otolaryngol Head Neck Surg 134:558-564, 2006 8. Romanow J, Catalano P: Initial US: Pilot study: Palatal implants for the treatment of snoring. Otolaryngol Head Neck Surg 134:551-557, 2006 9. Nordgard S, Stene B, Skjostad K: Soft palate implants for the treatment of mild to moderate obstructive sleep apnea. Otolaryngol Head Neck Surg 134:565-570, 2006
241 10. Walker R, Levine H, Hopp M, et al: Palatal implants: A new approach for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg 135:549-554, 2006 11. Huang Y, White D, Malhotra A: The impact of anatomic manipulations on pharyngeal collapse. Chest 128:1324-1330, 2005 12. Skjostad K, Stene B, Nordgard S: Consequences of increased rigidity in palatal implants for snoring: A randomized controlled study. Otolaryngol Head Neck Surg 134:63-66, 2006