- Email: [email protected]
Reply to Letter to the Editor regarding article by Miranda et al.
Accepted Manuscript Reply to Letter to the Editor Regarding Article by Miranda et al. Shane D. Morrison, MD, MS, Yusha Liu, MD, PhD, Hakim K. Said, MD, FACS PII:
S1748-6815(16)30558-7
DOI:
10.1016/j.bjps.2016.11.029
Reference:
PRAS 5187
To appear in:
Journal of Plastic, Reconstructive & Aesthetic Surgery
Received Date: 26 November 2016 Accepted Date: 29 November 2016
Please cite this article as: Morrison SD, Liu Y, Said HK, Reply to Letter to the Editor Regarding Article by Miranda et al., British Journal of Plastic Surgery (2017), doi: 10.1016/j.bjps.2016.11.029. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Reply to Letter to the Editor Regarding Article by Miranda et al. Shane D. Morrison MD, MS1, Yusha Liu MD, PhD1, and Hakim K. Said MD, FACS1 1
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Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Washington School of Medicine, Seattle, WA
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Corresponding Author: Hakim K. Said MD, FACS Division of Plastic and Reconstructive Surgery, Department of Surgery University of Washington School of Medicine 1959 NE Pacific Street Seattle, WA 98105 T: 206-543-5516 F: 206-598-2530 E: [email protected]
ACCEPTED MANUSCRIPT
Dear Sir,
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We thank the author for his insightful and well-thought comments on our article, “Improved healthcare economic outcomes after liposomal bupivacaine administration in first-stage breast reconstruction,” and the current utilization of liposomal bupivacaine in general 1. There have been many advances with the use liposomal bupivacaine for post-operative analgesia both within and outside of plastic surgery 2. As mentioned in the letter by Layton, further understanding of the safety profile and efficacy in a novel therapeutic for post-operative analgesia is crucial for its widespread adoption.
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Various studies, especially in breast augmentation and reconstruction, have documented efficacy and safety of liposomal bupivacaine 2. Minkowitz et al conducted a phase II, randomized, active-controlled, double-blind, multicenter study and phase III, randomized, double-blind, multicenter study to investigate the safety of liposomal bupivacaine compared to bupivacaine hydrochloride in augmentation mammaplasty 2, 3. In both studies local infiltration of liposomal bupivacaine was done within the breast pocket with a concomitant multi-modal approach to pain management with oral medications. There were no adverse events reported, and no significant difference in tolerability. After two-years, the integrity of the implants was similar between both arms of the study. Smoot et al also conducted a randomized, active-controlled, double-blind, multicenter study comparing liposomal bupivacaine and bupivacaine hydrochloride in patients undergoing bilateral submuscular augmentation mammaplasty 4. No adverse events were reported and there was significantly lower opiate medication usage in the liposomal bupivacaine arm at 48 hours. In first-stage breast reconstruction with tissue expander placement, Abdelsattar et al showed decreased patient-reported pain scores on the day of surgery and less opiate usage with liposomal bupivacaine 5. In fact a group of patients undergoing various cosmetic procedures assigned the monetary value of liposomal bupivacaine at $230 (range, $100 - $1000) due to its effective pain management, even if not covered by insurance 2.
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Studies also point to decreased length of stay, and hospital and patient costs with use of liposomal bupivacaine. With the current emphasis on cost-efficient care, any tool that can contribute to timely, reliable patient discharge may facilitate ambulatory surgical pathways. That, in turn, can reduce overall costs of care per patient. It may well be that the operational benefit of streamlining patient care exceeds the demonstrable difference in medications used. Certainly, on an institutional level, enabling consistent patient throughput offers value. Whether this can be demonstrated across a variety of clinical applications remains to be seen, and is worth study. While numerous studies point to the benefits of liposomal bupivacaine, as Layton discusses, there are still further aspects in need of research. In a multi-modal approach to pain, we still do not know the exact effect liposomal bupivacaine has relative to other pain management systems. Larger scale studies are needed to
ACCEPTED MANUSCRIPT
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uncover this, and determine if the improved healthcare economic outcomes and patient-reported pain management are retained. Expansion of the use of liposomal bupivacaine into other realms of plastic surgery like hand surgery also warrants investigation. Nevertheless, our current data suggest liposomal bupivacaine is potentially a revolutionizing agent in post-operative analgesia.
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Conflict of Interest: N/A Funding: N/A
ACCEPTED MANUSCRIPT
References
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1. Miranda SG, Liu Y, Morrison SD, et al. Improved healthcare economic outcomes after liposomal bupivacaine administration in first-stage breast reconstruction. J Plast Reconstr Aesthet Surg 2016: 69: 1456-7. 2. Vyas KS, Rajendran S, Morrison SD, et al. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg 2016: 138: 748e-56e. 3. Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet Surg J 2012: 32: 186-93. 4. Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J 2012: 32: 69-76. 5. Abdelsattar JM, Boughey JC, Fahy AS, et al. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol 2016: 23: 465-70.
S1748-6815(16)30558-7
DOI:
10.1016/j.bjps.2016.11.029
Reference:
PRAS 5187
To appear in:
Journal of Plastic, Reconstructive & Aesthetic Surgery
Received Date: 26 November 2016 Accepted Date: 29 November 2016
Please cite this article as: Morrison SD, Liu Y, Said HK, Reply to Letter to the Editor Regarding Article by Miranda et al., British Journal of Plastic Surgery (2017), doi: 10.1016/j.bjps.2016.11.029. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Reply to Letter to the Editor Regarding Article by Miranda et al. Shane D. Morrison MD, MS1, Yusha Liu MD, PhD1, and Hakim K. Said MD, FACS1 1
RI PT
Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Washington School of Medicine, Seattle, WA
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Corresponding Author: Hakim K. Said MD, FACS Division of Plastic and Reconstructive Surgery, Department of Surgery University of Washington School of Medicine 1959 NE Pacific Street Seattle, WA 98105 T: 206-543-5516 F: 206-598-2530 E: [email protected]
ACCEPTED MANUSCRIPT
Dear Sir,
RI PT
We thank the author for his insightful and well-thought comments on our article, “Improved healthcare economic outcomes after liposomal bupivacaine administration in first-stage breast reconstruction,” and the current utilization of liposomal bupivacaine in general 1. There have been many advances with the use liposomal bupivacaine for post-operative analgesia both within and outside of plastic surgery 2. As mentioned in the letter by Layton, further understanding of the safety profile and efficacy in a novel therapeutic for post-operative analgesia is crucial for its widespread adoption.
EP
TE D
M AN U
SC
Various studies, especially in breast augmentation and reconstruction, have documented efficacy and safety of liposomal bupivacaine 2. Minkowitz et al conducted a phase II, randomized, active-controlled, double-blind, multicenter study and phase III, randomized, double-blind, multicenter study to investigate the safety of liposomal bupivacaine compared to bupivacaine hydrochloride in augmentation mammaplasty 2, 3. In both studies local infiltration of liposomal bupivacaine was done within the breast pocket with a concomitant multi-modal approach to pain management with oral medications. There were no adverse events reported, and no significant difference in tolerability. After two-years, the integrity of the implants was similar between both arms of the study. Smoot et al also conducted a randomized, active-controlled, double-blind, multicenter study comparing liposomal bupivacaine and bupivacaine hydrochloride in patients undergoing bilateral submuscular augmentation mammaplasty 4. No adverse events were reported and there was significantly lower opiate medication usage in the liposomal bupivacaine arm at 48 hours. In first-stage breast reconstruction with tissue expander placement, Abdelsattar et al showed decreased patient-reported pain scores on the day of surgery and less opiate usage with liposomal bupivacaine 5. In fact a group of patients undergoing various cosmetic procedures assigned the monetary value of liposomal bupivacaine at $230 (range, $100 - $1000) due to its effective pain management, even if not covered by insurance 2.
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Studies also point to decreased length of stay, and hospital and patient costs with use of liposomal bupivacaine. With the current emphasis on cost-efficient care, any tool that can contribute to timely, reliable patient discharge may facilitate ambulatory surgical pathways. That, in turn, can reduce overall costs of care per patient. It may well be that the operational benefit of streamlining patient care exceeds the demonstrable difference in medications used. Certainly, on an institutional level, enabling consistent patient throughput offers value. Whether this can be demonstrated across a variety of clinical applications remains to be seen, and is worth study. While numerous studies point to the benefits of liposomal bupivacaine, as Layton discusses, there are still further aspects in need of research. In a multi-modal approach to pain, we still do not know the exact effect liposomal bupivacaine has relative to other pain management systems. Larger scale studies are needed to
ACCEPTED MANUSCRIPT
RI PT
uncover this, and determine if the improved healthcare economic outcomes and patient-reported pain management are retained. Expansion of the use of liposomal bupivacaine into other realms of plastic surgery like hand surgery also warrants investigation. Nevertheless, our current data suggest liposomal bupivacaine is potentially a revolutionizing agent in post-operative analgesia.
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Conflict of Interest: N/A Funding: N/A
ACCEPTED MANUSCRIPT
References
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1. Miranda SG, Liu Y, Morrison SD, et al. Improved healthcare economic outcomes after liposomal bupivacaine administration in first-stage breast reconstruction. J Plast Reconstr Aesthet Surg 2016: 69: 1456-7. 2. Vyas KS, Rajendran S, Morrison SD, et al. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg 2016: 138: 748e-56e. 3. Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet Surg J 2012: 32: 186-93. 4. Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J 2012: 32: 69-76. 5. Abdelsattar JM, Boughey JC, Fahy AS, et al. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol 2016: 23: 465-70.