Presented at ORBS 2015, September 21 23, 2015, Nottingham, UK

Transcription

1 SERI Surgical Scaffold in Two-Stage Breast Reconstruction: Investigator Satisfaction, Breast Stability, and Safety Profile Over Two Years in a Prospective Clinical Study Nolan Karp, MD 1 ; Mihye Choi, MD, FACS 2 ; David A. Kulber, MD, FACS 3 ; Susan Downey, MD, FACS 4 ; Gloria Duda, MD 5 ; Gabriel M. Kind, MD 6 ; Mark L. Jewell, MD 7 ; Diane K. Murphy, MBA 8 ; Max R. Lehfeldt, MD, FACS 9 ; Neil Fine, MD, FACS 10 1 NYU School of Medicine, New York, NY, USA; 2 NYU Plastic Surgery, NYU Langone Medical Center, New York, NY, USA; 3 USC Keck School of Medicine, Los Angeles, CA, USA; 4 Private Practice, Los Angeles, CA, USA; 5 Aesthetic Center for Plastic Surgery, McLean, VA, USA; 6 Private Practice, San Francisco, CA, USA; 7 Private Practice, Eugene, OR, USA; 8 Allergan, Inc., Irvine, CA, USA; 9 Teleos Plastic Surgery, Pasadena, CA, USA; 10 Northwestern Specialists in Plastic Surgery, Chicago, IL, USA Presented at ORBS 2015, September 21 23, 2015, Nottingham, UK

2 Disclosures The financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors N Karp M Choi DA Kulber S Downey G Duda has served as a clinical investigator for Allergan, Inc., Mentor, and LifeCell. GM Kind ML Jewell has served as a consultant for Allergan, Inc., Keller Medical, Solta, and New Beauty Magazine; has received research funding through grants or contracts from Allergan, Inc., Mentor, Pfizer-Excaliard, and Solta; and holds patents or has patents pending with AorTech and Pfizer- Excaliard. DK Murphy is an employee of Allergan, Inc., and owns stock in the company. MR Lehfeldt N Fine This study was sponsored by Allergan, Inc., Irvine, CA, USA. Writing and editorial assistance was provided to the authors by Peloton Advantage, Parsippany, NJ, USA, and was funded by Allergan, Inc. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. 2

3 Introduction Post-mastectomy breast reconstruction with implant placement may include the use of a device to provide soft-tissue support and stability All soft-tissue support products have been associated with complications, such as seroma, infection, and reconstruction failure 1-3 SERI Surgical Scaffold (SERI) is a silk-derived scaffold developed to provide soft-tissue support o SERI has good biocompatibility 4 o SERI is bioresorbed over 12 months, accompanied by transfer of weightbearing to the newly generated tissue 5 A long-term, prospective, multicenter study evaluated the clinical safety, efficacy and surgeon/subject satisfaction of SERI following implantation during stage 1 surgery in 2-stage breast reconstruction (SURE-001) o Long-term findings over 2 years are reported here 1. Ho G, et al. Ann Plast Surg. 2012;68: Kim JYS, et al. Plast Reconstr Surg. 2012;129: Mendenhall SD, et al. Plast Reconstr Surg. 2015;135:29e-42e. 4. Horan RL, et al. Hernia 2009;13: Gross JE, et al. Plast Reconstr Surg. 2014;134:700e-704e. 3

4 Prospective, Multicenter, 24-Month Study of SERI in 2-Stage Breast Reconstruction Subjects Adult women undergoing post-mastectomy reconstruction: no radiation treatment prior to the study* SERI implantation SERI implanted at stage 1 of breast reconstruction for lower breast soft-tissue support Assessments Breast soft-tissue stability using 3D-imaging and dimensional analysis Safety profile, including adverse events (AEs) and reoperations/explantations Surgeon satisfaction (range: 0 [very dissatisfied] to 10 [very satisfied]): primary endpoint at month 6 Surgeon ease of use assessment (1 [very difficult] to 5 [very easy]) Subject satisfaction with breast reconstruction (1 [very dissatisfied] to 5 [very satisfied]) Analysis Descriptive analyses in the per protocol (PP; primary analysis set) and full analysis (FA) populations *Per the protocol, subjects receiving radiation during the study were not included in efficacy or satisfaction analyses. 4

5 Baseline Subject and Stage 1 Surgery Characteristics The FA population comprised 139 subjects who had SERI implanted in a total of 214 breasts Among 36 subjects with protocol deviations, 28 subjects received radiation therapy during the study (PP population, n=103) Characteristic FA Population (n=139) Age, mean (SD), years 49.8 (10.19) White, % 77.0 BMI, mean (SD), kg/m (4.22) Procedure time, mean (SD), minutes 85.8 (39.13) SERI placement, % Unilateral 46.0 SERI trimmed to <200 cm 2, %* 70.6 Initial TE fill volume 200 cc, % 66.8 Completed with 1 3 volume fill visits, % 39.6 Number of TE fills, mean (SD) 4.3 (2.06) *Starting size of SERI was 250 cm 2. 5

6 Mean Breast Anatomy Measurements Over 24 Months* Breast anatomy measurements changed little from months 6 through 24 Soft-tissue stability of the lower breast was maintained through 24 months No evidence of late-term soft-tissue stretch was noted Baseline Month 6 Month 12 Month Sternal Notch to Apex Height Apex to IMF *Based on the PP population (n=103, 160 breasts). IMF, inframammary fold. 6

7 Representative Photos Over 24 Months Subject ID Diagnosis TE Final TE Fill Volume Implant Prophylactic Mastectomy Natrelle 133SV cc Pre-operative Stage 1 Pre-operative Stage 2 Natrelle Smooth/round (450 cc) Month 12 Month 24 7

8 Representative Photos Over 24 Months Subject ID Diagnosis TE Final TE Fill Volume Implant Breast Cancer Natrelle 133MV cc Pre-operative Stage 1 Pre-operative Stage 2 Natrelle Smooth/round (550 cc) Month 12 Month 24 8

9 Representative Photos Over 24 Months Subject ID Diagnosis TE Final TE Fill Volume Implant Prophylactic Mastectomy Natrelle 133MV cc Pre-operative Stage 1 Pre-operative Stage 2 Natrelle Smooth/round (550 cc) Month 12 Month 24 9

10 Predefined Adverse Events of Interest Occurring at >2% Frequency (by Breast)* Of 139 subjects, 76 experienced 130 predefined AEs of interest; most (78.5%) were mild in severity Four device-related infections and 1 superficial wound infection occurred; no deep wound infections or suture infections occurred Adverse Event, n (%) FA Population (n=214 breasts) Tissue or skin necrosis 18 (8.4) Seroma 16 (7.5) Capsular contracture 16 (7.5) Wrinkling/rippling 16 (7.5) Wound dehiscence 11 (5.1) Hematoma 9 (4.2) Skin rash 7 (3.3) Cellulitis 7 (3.3) Breast redness 6 (2.8) Delayed wound healing 6 (2.8) Asymmetry 5 (2.3) *Percentages were calculated using the total number of breasts with implants (n=214) as the denominator. 10

11 Adverse Events Leading to Reoperation/ SERI Explantation (by Breast)* Of 214 breasts, 13 (6.1%) required reoperation/seri explantation SERI was retained in 201 of 214 breasts (93.9%) at 24 months Reoperation/explantation was required in 1 subject for ptosis, in none for malposition Subject Device Explanted AE Time After Stage 1 No. Surgery, Months SERI; implant Breast infection; wound dehiscence SERI; implant (bilateral) Capsular contracture 9, 10, SERI Breast reconstruction SERI; TE (bilateral) Scaffold/TE infection 2, SERI; implant Breast reconstruction SERI; TE Periprosthetic infection SERI; TE Radiation-induced soft-tissue SERI; TE damage Breast reconstruction SERI; TE Ruptured TE; breast reconstruction SERI Cellulitis SERI Partial nonintegration 9 *Percentages were calculated using the total number of breasts with implants (N=214) as the denominator. Calculated to the nearest month, based on 30 days per month. Three successive procedures: capsulotomy and breast revision; implant exchange; free transverse rectus abdominus myocutaneous flap over 2-month period. TE, tissue expander. 11

12 The BREASTrial: Stage I. Outcomes From Time of Tissue Expander and Acellular Dermal Matrix Placement to Definitive Reconstruction This was a single-center, randomized, 2-year study of 128 subjects (199 breasts) undergoing immediate-stage tissue expander breast reconstruction using AlloDerm (LifeCell Corp.; Branchburg, NJ) or DermaMatrix (Synthes, Inc.; West Chester, Pa) 1 Parameter (%) All Breasts (n=116; 182 breasts) AlloDerm (n=59; 94 breasts) DermaMatrix (n=57; 88 breasts) Overall complication rate (%) Skin necrosis Infections Seroma Hematoma Poor integration Final TE volume (cc) Mean (range) 519 ( ) 517 ( ) 522 ( ) Number of expansions Mean (range) 3.8 ( ) 3.7 ( ) 4.0 ( ) 1. Mendenhall SD, et al. Plast Reconstr Surg. 2015;135:29e-42e 12

13 Excellent Surgeon and Subject Satisfaction Surgeons reported a high degree of satisfaction with SERI at month 6; satisfaction ratings remained high through month 24 Surgeons also rated SERI as easy or very easy to use during implantation for >98% of subjects Mean subject satisfaction with breast reconstruction (5-point rating scale) was 4.4 at month 6; from months 6 24, 92.4% to 97.4% of subjects reported being satisfied or very satisfied Per protocol (n=103) Full analysis (n=139) Very satisfied Satisfaction Score Very dissatisfied Stage 2 Month 6 Month 12 Month 18 Month 24 13

14 Conclusions SERI for soft-tissue support yielded durable breast mound stability, particularly for the lower pole of the breast Subject satisfaction with breast reconstruction was high across all time points AE rates were lower or in line with expectations o Rates of surgical complications and explantations of SERI were low Surgeons reported consistently high satisfaction with SERI over 24 months SERI provides a safe, long-term benefit for soft-tissue support and repair in 2-stage breast reconstruction 14