TEOSYAL PEN: Personal experience after 12 months on 285 consecutive patients Dr. Dell Avanzato Roberto AMWC 2016, 14 th Aesthetic & Anti-aging Medicine World Congress 31 March, 1 2 April, 2016
BACKGROUND Looking for patient overall comfortable experience Patient comfort during aesthetic procedures is important Minimal pain ranked third in importance only surpassed by aesthetic outcome and communication for patient willingness to undergo skin rejuvenation treatments. 1 Injection discomfort can be a significant source of patient anxiety, especially for the first-time patient. 1. Rosenthal KJ. Anesthesia for skin rejuvenation. Ophthalmol. Clin North Am. 1998;11:207 217.
HYALURONIC ACID INJECTIONS ARE ASSOCIATED WITH FEAR As a large European study among 236 patients and 30 practitioners showed (Kantar Health, 2014, Report N 40HB64), 3 major fears may prevent patients from getting an aesthetic procedure. They mainly worry about (1) what they can expect as a final result, (2) whether it will hurt and (3) how long the recovery time will be. Criteria important or very important Natural Results Side effects Pain during injection PATIENTS BEFORE FIRST INJECTION 97.6% 69.0% 64.3% PATIENTS ALREADY INJECTED 94.4% 76.7% 53.6%
BACKGROUND Looking for painless injection Ergonomics show that more pressure is linked to less precision Nowadays, techniques require more injection strength than ever before (in particular for volume restoration), paired with thinner needle and cannulas. 10 N to 50 N This is the pressure needed when injecting dermal fillers => 5 kg compressing in the same minimal point of injection. The control of pressure and precision is extremely difficult, leading to discomfort for the patient, as well as post injection site reaction (ecchymosis and swelling).
WHAT PHYSICIANS NEED The European trial (Kantar Health, 2014, Report N 40HB64) underlined also the major critical factors for 30 interviewed physicians Precision (depth, delivery, dosage) Ease of injection in sensitive areas Product saving Patient loyalty The goal would be to have a homogeneous flow and constant speed of injection, without peak of pressure To focus on the artistic aspect of the work, to reach the best possible natural result, reducing risk of over-correction for a better comfort for patients.
INTRODUCTION: AN INNOVATIVE APPROACH FOR THE INJECTION The device used is a new motorized, electronic, cordless hyaluronic acid injection system that allows a regular and homogeneous delivery of several types of hyaluronic acids gels The device: Injection Flow mode 3 speeds : Slow/Medium/Fast On/Off Injection Drop mode 3 drop sizes : Small/Medium/Large Activation button Patented TeoLink (single use) Syringe Rewind button Technical features Cordless (weightless: 40 grams) 2 injection modes: drop or flow mode Flow mode with 3 speeds: highly precise and homogeneous delivery Drop mode with 3 drop size TEOSYAL PEN manufactured by Juvaplus. CE marking: Class IIa (CE 0434). Compatible with: most hyaluronic acid gels and all types of needles and cannulas
INTRODUCTION: FOCUS ON THE DEPTH OF INJECTION The device has two different modes for the delivery of hyaluronic acid gels: FLOW MODE Allows three different speeds for the treatment of different depths DROP MODE Slow speed for superficial wrinkles and delicate zones (tear through) Medium speed for superficial to moderately deep wrinkles Fast speed for deep injections Allows 3 different size of drops for a maximum of precision in any areas TEOSYAL PEN manufactured by Juvaplus. CE marking: Class IIa (CE 0434).
AIM OF THE STUDY The aim of this study was to assess the efficacy of the injection with an electronic device, on the reduction of the patient discomfort and an optimization of the overall experience, during the treatment with different HA gels in various facial areas.
MATERIAL & METHODS Trial lasted for 10 months and involved a total of 285 patients: male and female subjects ages 18 to over 70 years old with the following categorization: AGE CLASSES NUMBER OF PATIENTS 20 18 20-30 37 30-40 47 40-50 89 > 50 94 Exclusion criteria: Patients were excluded if they had used aspirin, non steroidal anti-inflammatory drugs (NSAIDS), anticoagulants, St. John's Wort, or high doses of Vitamin E within two weeks prior treatment. Inclusion criteria: Patients that have received at least one manual injection with HA gels in the past year.
MATERIAL & METHODS Method: Visit and patient history Treatment preparation: removing make up, cleansing, and skin disinfection Assembly of the device: setting up the syringe, the link and the needle or cannula Before treatment, patients did not receive any local anesthetic cream Treatment: a total of 500 phyals were carried out using 6 different types of HA gels: free HA, semi cross-linked HA, four cross-linked dynamic HA gels (with increasing viscosity parameter). In many cases, patients received more than one injection during one session.
MATERIAL & METHODS Treatments The pie chart below represents the different areas with the corresponding percentage of treated patients. 19,4% 14,8% 28,2% 3,0% 11,0% 17,0% 3,6% 3,0% periorbital and perioral area nasolabial folds nose remodeling lips remodeling zigomathic area temporal area chin area for revitalization
MATERIALS & METHODS Patient Self-assessment Questionnaire After the injection, patients were asked to complete a questionnaire regarding their evaluation of fear, pain and comfort. They were also asked about natural results, side effects (like swelling, redness, bruising) and overall impression during the HA injection with the device. QUESTIONS PAIN In comparison with the previous manual injection, the treatment was: COMFORT In comparison with the previous manual injection, the treatment was: FEAR In comparison with the previous manual injection, you felt: SATISFACTION Would you prefer to have your next injection with the device? POSSIBLE ANSWERS 1. LESS PAINFUL 2. EQUALLY PAINFUL 3. MORE PAINFUL 1. LESS COMFORTABLE 2. EQUALLY COMFORTABLE 3. MORE COMFORTABLE 1. LESS FEAR 2. EQUALLY FEAR 3. MORE FEAR 1.YES 2. NO
RESULTS Patients significantly expressed less pain when treated with the device in comparison with manual injection. 100,00 90,00 Pooled results 80,00 70,00 60,00 Less Equal More 10% 3% 50,00 40,00 87% 30,00 20,00 10,00 Chi-Square = 371.5158 df = 2 p <0.001 0,00 < 20 anni 20-30 anni 30-40 anni 40-50 anni > 50 anni Age Almost 90% of patients felt less pain with the device Very few patients (3%) experienced more pain with the device
RESULTS 100,00 Patients significantly expressed more comfort when treated with the device in comparison with manual injection. They also report less AEs (redness, swelling, bruising) 90,00 80,00 70,00 60,00 50,00 40,00 30,00 20,00 Less Equal More Pooled results 83% 3% 14% 10,00 Chi-Square = 318.9684 df = 2 p < 0.001 0,00 < 20 20-30 30-40 40-50 > 50 Age < 20 anni 20-30 anni 30-40 anni 40-50 anni > 50 anni More than 80% of patients considered treatment more comfortable Patients also reported less immediate side effects and more natural results Very few patients (3%) preferred manual injection
RESULTS Patients were significantly less scared when treated with the device in comparison with manual injection. An absolute clear preference to have futher treatments with the device was also reported. 100,00 90,00 80,00 70,00 60,00 50,00 40,00 30,00 20,00 10,00 0,00 Less Equal More < 20 anni 20-30 anni 30-40 anni 40-50 anni > 50 anni Age Pooled results 6% 2% 92% Chi-Square = 446.4000 df = 2 p < 0.001 PATIENT SATISFACTION SURVEY: Would you prefer to have your next treatment with the device? YES NO Chi-Square = 257.6877 df = 1 p < 0.001 278 (98%) 7 (2%) More than 90% of patients were less scared with the device 98% of patients preferred treatments with the device
DISCUSSION Given the same needle/cannula of the manual injection, one possible explanation regarding the reduced level of pain and immediate side effects, is the smoother and highly precise administration allowed by the electronic control of the pressure exerted by the device, as showed below A) B) Different delivery of an high viscous cross-linked HA gel, with: A) Manual injection B) Electronic Device With the device, there is always a well-controlled constant flow, regardless of tissue resistance or gel viscosity.
Applied pressure DISCUSSION Constant pressure control (no strength required for injection, no peak of pressure), as well as a precise and homogeneous product flow allowed by the device are likely to reduce the pain for the patient and allow minimizing micro-traumas also in problematic areas (nose, periorbital and perioral area).
CONCLUSIONS Based on the results of this study, the device provides a best management of pain, fear and patient comfort (with subjective evaluation) during dermal filler injections compared to manual injection. Extremely significant (p<0.001) pain reduction (87% of patients), fear reduction (92% ) and comfort increase (83%), compared to manual injection. Reduction of immediate side effects, regardless of the high sensitivity of the treated area (nose, periorbital and perioral area). Very high patient satisfaction: 98% of subjects would prefer having further treatments with the device.
CONCLUSIONS The results presented here corroborate the European trial (Kantar Health, 2014, Report N 40HB64): Criteria European Trial (% of patients) Observed results (% of patients) Pain reduction reported 70.9% 87% AEs reduction reported 70% 83% Patient satisfaction 90.5% 98 % and show the possibility to bring filler injections to a new aesthetic level of precision and comfort, with no more risk for the practitioner to overcorrect the patients. Increasing patient comfort and positive experience, may encourage the development of routine regimens of hyaluronic acid dermal filler treatments as well as increase patient loyalty. In my clinical daily practice, this device has almost completely substituted conventional manual injections, with the best benefits for difficult, sensitive or tricky areas (lips, tear troughs, nose, temples) or for finest correction where injecting by hand is almost impossible.
Thank you all for the attention