Why should we treat Dysphagia

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2 Why should we treat Dysphagia

3 Dysphagia Market : Estimated 15 million adult patients in USA Frequently occurring condition in many disease states CVA is most frequent diagnosis 15% 10% 5% 5% 5% 60% CVA Alzheimer's Parkinson's TBI HNC Other

4 Burden of illness 66% 36% Stroke w ith dysphagia Stroke, no dysphagia 20% 17% 13% 10% 3% 4% Occurrence of complications 1 year post stroke in patients with severe dysphagia and a PEG compared to patients without dysphagia. (CMS data file analysis) Death Pneumonia Sepsis Decubitus Covance. VitalStim Therapy economic model. 2005

5 Complications of PEG tubes 70% 55% 30% 22% PEG related complications Aspiration pneumonia 1 yr mortality 30 day mortality American Gastroenterological Association Technical Review on Tube Feeding for Enteral Nutrition. Gastroenterol. 1995; 108:

6 Cost of enteral tube feeding Total annual cost to Medicare for enteral feeding supplies was more than $670 million (6% of annual DME budget). Estimated cost of providing 1 year of feeding via PEG is $31,832. Main components of this cost include the initial PEG procedure, enteral formula and hospital charges for major complications. Callahan et al. J Am Geriatr Soc 2001; 49(11):

7 Dysphagia due to stroke Majority of dysphagic patients are cortical or brainstem stroke patients Dysphagia generally resolves in majority of cortical stroke patients within 6 months Brainstem stroke causes more severe and permanent dysphagia due to damage to cranial nerve nuclei Medical priority in treating dysphagia: Prevent dehydration and malnutrition Avoid development of aspiration pneumonia

8 Swallow dysfunctions in CVA Swallow system is impaired as a result of multiple contributing factors: Decreased neural drive to swallowing musculature Insufficient sensory feedback for efficient motor control Muscle atrophy as a result of disuse Myofascial restrictions as a result of disuse

9 Disuse atrophy Dysphagia is associated with disuse atrophy, especially of fast-twitch, type II muscle fibers Patients elicit spontaneous swallows with less frequency than non-dysphagic counterparts Individuals with compromised health and those of advanced age are most susceptible to disuse atrophy Significant atrophy is evident as soon as 72 hours poststroke Atrophy is reversible with exercise Burkhead et al. Dysphagia. Jul 2007;22(3): Urso et al. European Journal of Applied Physiology. 2006;96: Nicosia et al. J Gerontol A Biol Sci Med Sci. Nov 2000;55(11):M

10 Possible signs of dysphagia Coughing/clearing of throat after swallow Abnormal volitional cough Decreased voice quality (wet, hoarse, weak) Recurring chest infections Requires multiple swallows or special maneuvers to clear throat Difficulty completing a meal Feeling of food being stuck in the throat Requires diet to be modified (e.g., thickening, pureed food, soft solids) Difficulty initiating a swallow Spillage of food/liquid from lips and/or drooling

11 Traditional Dysphagia Management CVA Management strategies often reinforce underlying impairments Patients are often taught compensatory swallowing techniques (e.g., turning head or tucking chin when swallowing) to improve swallow safety but at the expense of normal swallow dynamics Diets are often modified to a consistency requiring slower contractions Diets are often limited to a quantity and consistency that limits aspiration but decreases oral intake

12 Limited treatment options Compensation (mainstay of current management) Head turn Chin tuck Modified diet Supraglottic swallow Medical management PEG Medication anti-reflux, botox, etc. Surgery dilatation, myotomy, etc Therapy Biofeedback (semg, pressure) Effortful swallow Oromotor exercise Thermotactile stim Mendelsohn, Masako, Shaker Electrotherapy (recent addition = VitalStim)

13 What is VitalStim Therapy? Use of Neuromuscular Electrical Stimulation (NMES) to reeducate swallow Device and method cleared by the FDA in 2001 as safe and efficacious in treatment of dysphagia Pioneer work done by Ms Marcy Freed SLP.

14 How it all started Chance favors only the prepared mind. (Louis Pasteur)

15 FDA clearance for VITALSTIM Pioneer work started by Ms Marcy Freed, SLP FDA clearance was obtained for external neuromuscular electrical stimulation in the laryngeal neck region based on a study of 892 in-patients and out-patients from 1993 to 1998

16 FDA clearance for VITALSTIM In relation to some improvement based on the swallowing function scale used, electrical stimulation had a success rate of over 80% compared with 33% for thermal application. For patients with severe dysphagia, electrical stimulation had a success rate of over 90% restoring swallowing patients past the point of requiring a PEG whereas thermal application had only a success rate of 39%.

17 FDA clearance for VITALSTIM For patients with severe dysphagia, electrical stimulation had a success rate of 38.3% in restoring full normal swallow and thermal application a success rate of 0%.

18 EDUCATION : Vitalstim

19 A Busy class in Hong Kong

20 Launch in Jakarta

21 Launch in Manila s premium Hospital

22 Learning through fun.

23 Launching in Japan

24 ASIAN NEWS : Malaysia

25 CREATING SUCCESS STORIES

26 VITALSTIM : Target Market All patients with known history of Dysphagia Adults Paediatric Acute Chronic Common conditions include: CVAs, Other neurological disorders Head and neck cancers Post surgery, head injury Developmental conditions ( eg, CP)

27 VITASLTIM : What does it do? Pulsed current depolarizes sensory and motor neurons transcutaneously Facilitates strengthening process of the swallowing muscles Increases sensory feedback and timing

28 Normal Swallow Review Two distinct phases of the swallow: Voluntary phase Involuntary phase Literature describes several stages Under voluntary control: Anticipatory and Oral stages Under involuntary control: Pharyngeal stage Esophageal stage REVIEW NORMAL / ABNORMAL SWALLOW MBS

29 Muscles active during oral stage Function Muscle Accessible to stim Lip closure Orbicularis Oris Yes Buccal tone Buccinator Yes Tongue motility Intrinsic tongue muscles No Extrinsic tongue muscles Yes Chewing Masseter Temporalis Yes Yes Anticipatory and Oral Stage Pterygoids Difficult Tongue base retraction Hyoglossus Styloglossus Yes No Palatoglossus No Velopharyngeal closure Levator veli palatini Tensor veli palatini No No Superior pharyngeal constrictor No

30 Extrinsic laryngeal muscles : KEY muscles during Pharyngeal Stage Muscles Digastrics Stylohyoid Mylohyoid Geniohyoid Sternohyoid Sternothyroid Omohyoid Thyrohyoid Pharyngeal Stage

31 Muscles active during pharyngeal stage Function Muscle Accessible to stim Pharyngeal squeeze Pharyngeal constrictors Yes (intensity must be high) Hyoid elevation with protraction Anterior belly digastric Geniohyoid Yes Yes Mylohyoid Yes Hyoid elevation with retraction Posterior belly digastric Stylohyoid No No Hyoid depression Sternohyoid Omohyoid Yes Yes Pharyngeal Stage Laryngeal elevation Thyrohyoid Yes Adduction vocal folds Interarytenoids Yes

32 Esophageal stage Involuntary Larynx lowers Esophageal peristalsis moves food to lower esophageal sphincter Cricopharyngeal muscle contracts to prevent reflux Peristalsis continues to move bolus to stomach Esophageal Stage Manual page 28

33 VITALSTIM : Typical treatment session Prepare skin, attach electrodes Stimulation remains on or 1 hour or as per patient tolerance During stimulation patient actively practices swallowing Progress patient with different foods/liquids as per tolerance

34 NOTICABLE EFFECTS OF VITALSTIM Audible swallow grab, pull, electrode peeling off sensation triggers the swallow better swallow with than without stim body language: sitting up staright, reaching for electrodes Change of voice

35 Limitations Denervated muscle does not respond to NMES Inability to elicit voluntary or reflexive swallow limits efficacy Structural abnormalities are not affected by NMES

36 Sample electrode placement Different electrode placements target different muscle groups

37 Indications for VitalStim A patient is indicated for dysphagia therapy when they: Show signs of, or are at risk for aspiration and/or Have difficulty managing their diet

38 Precautions, Contraindications Contraindicated Directly over active neoplasm or infection Directly over carotid sinus Caution Implanted electronics (cardiac demand pacemakers, ICDs, VNS) Uncontrolled seizure disorder

39 SHOW ME THE EVIDENCE!!!

40 Studies to date 11 positive studies and 1 meta-analysis in print corroborate positive findings reported in the field Use of NMES for dysphagia is safe Improvement in swallow scores is directly associated with use of electrical stimulation Use of NMES is finding widespread adoption among dysphagia therapists Both therapists and patients are very satisfied with outcomes NMES in conjunction with swallowing exercise is more effective than traditional treatment techniques alone Use of NMES tends to decrease inpatient length of stay as a result of improved swallow function

41 Safety All studies tracked for the occurrence of adverse events and none were reported across all patient ages and diagnoses No changes in pulse oxymetry readings, heart rate, or blood pressure (n=892) No reports of laryngospasm, bradycardia or electromagnetic interference with cardiac pacemakers No adverse events in the pediatric population Freed M. Use of electric stimulation to restore swallow function. FDA trial data; Christiaanse et al. NCSHA. Charleston; 2003

42 Efficacy Meta-analysis of current data (total n=255) demonstrates significant treatment effect of ES added to standard treatment interventions Carnaby-Mann et al. Arch Otolaryngol Head Neck Surg. Jun 2007;133(6):

43 Swallowing + concurrent NMES NMES with concurrent swallowing exercise increases laryngeal elevation during swallowing Pre-tx Post-tx 0.6 cm 2 cm Leelanamit, et al. Laryngoscope 2002 Dec;112:

44 Efficacy reported Survey of SLP s (users & nonusers, n=2,000) shows that majority of users and patients report good satisfaction. PEG tube dependency 60% 50% 40% 30% 20% 10% FOIS 0% Pre treatment Post treatment 0 FOIS (median) PEG tub dependency Crary et al. Dysphagia. 22 February 2007

45 Sustained gains Case series: Use of NMES + active swallowing therapy improves swallow function. FOIS Scale FOIS pre FOIS post FOIS 6mth Sustained Recovery in Chronic, Refractory Patients Carnaby-Mann et al. Electrotherapy for chronic dysphagia: A prospective case series. Presented at Dysphagia Research Society (DRS).

46 Removal of PEG 7 In retrospective review the use of VitalStim led to discontinuation of feeding tube in 6 out of 7 patients. 1 Pre-treatment Post-treatment Patients w ith feeding tube and minimal PO Shaw et al. Ann Otol Rhinol Laryngol. Jan 2007;116(1):36-44

47 Inpatient use Treatment is safe and leads to improved swallow (Belafsky, et al, n=22) Treatment accelerates discharge (Blumenfeld et al, n=40) Mild (limited oral intake) to moderate (PEG fed with minimal oral intake) dysphagia patients benefit most with over 80% discontinuing PEG (Shaw et al, n=18) Belafsky t al. The safety and efficacy of transcutaneous electrical stimulation in treating dysphagia: A preliminary experience. Abstract Scripps, CA and Wake Forest, NC. Blumenfeld et al. Otolaryngol Head Neck Surg. Nov 2006;135(5): Shaw et al. Ann Otol Rhinol Laryngol. Jan 2007;116(1):36-44.

48 NMES in chronic dysphagia Swallwing safety (lower=safer) Physiological effect of VitalStim (case series, n=8): Sensory stim improved swallow safety in 75% of patients Patient # No stim Sens stim Ludlow et al. Dysphagia. Dysphagia. Jan 2007;22(1):1-10.

49 New Generation Vitalstim Intelect Vitalstim

50 SEMG : Introduction Gives us the ability to see things through the aid of instruments that can not be seen, felt or touched with the normal senses. Electronic way to feel

51 NEW GENERATION VITALSTIM INTELECT VITALSTIM - Gaining the power of EMG AND - EMG + STIM option - With 04 Channel of Stim

52 Source of the Signal General Definition: Surface electromyography (SEMG) is the recording of muscle action potentials with surface skin electrodes. Muscle tissue like nerves generate electrical signals called Action Potentials.

53 The Sum of the Signals Muscle Fat Pad Skin Muscle fibers slightly overlap Solid circles closest to the skin contribute most to the SEMG signal Electrodes If there is adipose tissue more of the signal gets absorbed. Measures in mv Motor Units

54 Raw SEMG Display A R A DA BPF R TG I Tone S Display T

55 Advantages of SEMG Allows for functional movements Sensitive to low level activity Responsive to small changes in activity Distinguishes the activity of particular muscles and muscle groups

56 ADDING FURTHER - Surface EMG Triggered Stimulation

57 EMG Triggered Stimulation Stimulation is delivered to the muscle when the EMG activity reaches the threshold Ideally patient should perform functional activity during delivery of stimulation Very effective to Stimulate initiation of movement Improve quality of movement where weakness is key dysfunction

58 HAPPY FEEDING! Dinesh Verma, PT,MBA

59 Clinical Application Dr.Radika Vasudeva Consultant Speech-Language Therapist Integrated Speech & Swallow Works Pte Ltd Singapore

60 So far What is VITALSTIM Therapy? How does it work? Candidacy Emerging evidence: safety, efficacy New technology: semg+ VS

61 Assessment of Dysphagic patients Clinical Bedside assessments Objective Assessments Videofluoroscopy(VFS) Fiberoptic Endoscopic Examination of Swallowing(FEES)

62 Videofluoroscopy (VFS) Modified Barium Swallow Gold Standard Radiological procedure Understanding of the underlying physiology Excellent when read in conjunction with FEES

63 VFS studies: Observation Primarily observe for: Oral Phase Motility of the tongue Bolus control, manipulation and propulsion Pharyngeal Phase Pharyngeal transit time Pharyngeal constriction or squeeze - obliteration of space Pooling/residue in valleculae/sinuses Filling and emptying of valleculae and pyriform sinuses Penetration, aspiration when does this happen?? Why? Esophageal phase motility Cricopharyngeal dysfunction : overflow aspiration

64 VFS interpretation Attempt to determine the cause of the observed dysfunction: Lack of ability of the pharynx to squeeze Lack of coordination Lack of muscle contractility

65 VFS clippings Normal swallow Delayed swallow Aspiration Tongue pumping Weak swallow CPD

66 Doing VitalStim Therapy

67 Putting on the electrodes

68 Informing patient, Checking the levels

69 Working on the swallows objective baseline as guide

70 Case Studies: Outcomes with VITALSTIM therapy Case Studies: Outcomes with ViTALSTIM THERAPY

71 Phua Patrick 87 years Male / Chinese L basal Ganglia bleed with intraventricular bleeding On NG tube feeds Verbal, mild-mod dysarthria Open mouth, drooling Admitted to nursing home Family support- search for QOL

72 Phua Patrick Pre-treatment baseline-vfs on 20/3/08 Poor bolus manipulation, bolus propulsion,tongue pumping Mild penetration on all consistencies-thin, thick and porridge High risk of aspiration Delayed triggers for swallows: 4-6 secs latency Weak multiple swallows to clear each bolus Reduced hyo-laryngeal elevation Started on oro-motor therapy to work on the oral preparation for swallows

73 Phua Patrick VS therapy done after some initial oro-motor therapy sessions VFS findings post 8 sessions of VS therapy 15/4/08 Trace penetration on thickened fluids Mild aspiration on thin and mixed consistencies Improved latency for swallow triggers : 3-4 secs Reduced rate of laryngeal elevation Strength of pharyngeal squeeze improved Therapy continued-vs+exercises

74 Phua Patrick VFS repeated at the end of program ( 16 sessions of VS+exercises) Significantly improved swallow function Trace penetration on thin and thick only on cup drinking Swallows min delayed ~ 3 secs latency Mildly reduced rate of laryngeal elevation Mild valleacular residue noted to clear with double swallows Diet upgraded to rice+ minced meat/veg Nectar thick fluids with double swallows for liquids Gradually weaned off NG tube

75 Leong Siew Kee 82 years Male / chinese Bifrontal cerebral contusions secondary to fall late 2007 Mild L pariental SAH IHD Gastric BGIT L eye operation done Cognitive impairments ADL dependant, admitted to Nursing Home

76 Leong Siew Kee On Ng tube for several months after discharge In the nursing home, nurses gradually weaned him off the NG tube On blended diet and thickened fluids for months Referred for ST evaluation for upgrading diet

77 Leong Siew Kee VFS done pre-treatment 20/8/08 Mild silent penetration on thin fluids High risk of aspiration on thin fluids and mixed consistencies Delayed swallows: 6-7 secs latency Weak swallows- needed multiple swallows to clear bolus Post swallow residue; Valleculae > pyriform sinuses Reduced hyo-laryngeal elevation

78 Leong Siew Kee Treatment Vs therapy + exercises Feeding done during sessions

79 Leong Siew Kee VFS done post 8 sessions Trace transient penetration ONLY with thin fluids intermittently Nil aspiration on any of the consistencies Improved swallow triggers Latency : 3-5 secs Improved pharyngeal squeeze for swallows Needed only double swallows to clear bolus Nil residue post swallows

80 Leong Siew Kee Diet upgraded to Rice + chopped vegetables / meat Thin fluids in controlled sips when fed Slightly thicken to nectar consistency when self feeding Eating well to date! QOL

81 Ponnumurugan 34 yrs Indian male Brain surgery for a tumour Difficulty swallowing post surgery On NG tube Acute phase post surgery-lethargic, poor swallowing No intensive therapy

82 Ponnumurugan 3 weeks post surgery started intensive rehab involving VS therapy Daily sessions Oro-motor exercise Speech drills VFS post 5 sessions Some improvement with continuing problems with fluids Started on semisolids and solids

83 Ponnumurugan Gradual increase of oral intake Training continued After 15 sessions-vfs repeated NG tube removed On regular diet now Discharged from therapy- Back at work!

84 David Michael Phuah,16yrs Problem: Spastic cerebral Palsy Treatment Received: 14 sessions of Dysphagia Management Oro-motor assessment & therapy Before Aspiration with fluids Coughing and choking on feeding. Slow intake. Insufficient weight gain After VFS shows safer swallows Quicker intake Improvement with lip seal Better saliva control

85 In Conclusion VS is a vital component of Dysphagia Rehabilitation Best outcomes are achieved when used in conjunction with functional exercises Clinical decision making is the key! Join the group of clinicians in adding to the pool of emerging evidence..