Mastectomy with or without immediate implant reconstruction has similar 30-day perioperative outcomes

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Summary

Background

Immediate breast reconstruction (IBR) using implants remains a favorable reconstructive option in breast cancer. Understanding the added risk associated with IBR continues to enhance the risk counseling process and management of these patients.

Methods

Women undergoing mastectomy alone and mastectomy with tissue expander (TE) were identified in the ACS-NSQIP datasets. Specific complications examined included any, wound, medical complications, and deep infections. Bivariate and multivariate analyses were performed to identify predictors of outcomes, and propensity-matching was used to compare cohorts.

Results

A total of 42,823 patients who underwent either mastectomy alone (N = 30,440) or mastectomy with immediate TE placement (N = 12,383) were identified.

Notable independently associated perioperative differences between mastectomy and TE patients included: race (P < 0.001), comorbidity burden (P < 0.001), year of surgery (P < 0.001), ASA physical status (P < 0.001), functional status (P < 0.001), inpatient procedures (P < 0.001), bilateral procedures (P < 0.001), BMI (P < 0.001), age (P < 0.001), and lymphadenectomy (P < 0.001). IBR using TE was not found to be associated with greater risk of wound (3.3% vs. 3.2%, P = 0.855), medical (1.7% vs. 1.6%, P = 0.751), or overall (9.6% vs. 10.0%, P = 0.430) complications. TE placement was associated with higher rates of deep wound infections (2.0% vs. 1.0%, P < 0.001) and unplanned reoperations (6.9% vs. 6.1%, P = 0.025). Additionally, the rate of 30-day device loss was 0.8% in patients receiving reconstruction. Multivariate conditional (fixed-effects) logistic regression analysis failed to demonstrate significantly associated independent risk of wound, medical, or overall complications with the addition of TE.

Conclusions

Undergoing IBR with TE placement does not confer added risk of wound, medical, or overall morbidity relative to mastectomy alone based upon propensity-matched 30-day complication rates in 15,238 patients from the 2005–2011 ACS-NSQIP datasets. These findings further confirm the safety profile of prosthetic-based IBR.

Level of evidence: Prognostic/risk category, level II.

Introduction

Breast reconstruction following mastectomy provides patients with a psychosocial and aesthetic benefit,1, 2, 3, 4 yet postoperative morbidity can impact and alter recovery,4 satisfaction,1 and reconstructive cost.5 With rising national rates of bilateral mastectomy,6 immediate reconstruction, and the sustained popularity and use of implants,7 there is a significant need for generalizable outcomes data that quantify the relative risk of immediate tissue expander (TE) placement following mastectomy. Several studies to date have quantified the relative risk of reconstructive modality8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and defined predictors for device loss.19, 20 To date, there does not exist a direct comparison of matched patients who would be equally likely to select or undergo mastectomy alone or immediate breast reconstruction (IBR) using TE.

The importance of understanding population-level outcomes data as it relates to TE reconstruction lies in the opportunity to provide patients and surgeons with generalizable information to guide and enhance preoperative risk discussions, to assist in reconstructive modality selection, and to improve the understanding of risk in this commonly performed reconstructive procedure. The aim of this study was to compare the rates of 30-day perioperative complications following IBR using TE to mastectomy alone.

Section snippets

Database and analytic cohort

The 2005–2011 ACS-NSQIP databases were accessed on December 1, 2012 and queried to identify all female patients undergoing mastectomy alone or mastectomy with IBR using TE.21 Per NSQIP protocol, approximately 240 HIPPA compliant variables were collected for each encounter. These variables include patient demographic data and preoperative comorbid conditions, as well as procedure-related and outcomes data, including 30-day postoperative morbidity. Audits conducted through 2010 have shown an

Results

A total of 42,823 patients who underwent either mastectomy alone (N = 30,440) or mastectomy with concurrent TE placement (N = 12,383) were identified in the 2005–2011 ACS-NSQIP datasets. The majority of patients were Caucasian (71.2%) and 45–64 years of age (50.2%). Bivariate analysis revealed higher TE reconstruction rates during years 2009–2011 (P < 0.001), in Caucasian patients (P < 0.001), and in younger (P < 0.001) (Table 1). TE reconstruction patients had significantly lower ASA physical

Discussion

Immediate reconstruction has been shown to be associated with modality-specific risk14, 18 yet implant reconstruction has been demonstrated as an efficacious and reliable technique.26, 27 Evolving patterns of mastectomy use, including the rise in rates of prophylactic mastectomy and immediate implant-based breast reconstruction highlight the need to determine and characterize the relative risk of immediate TE reconstruction compared to mastectomy alone.6, 7

In this study, our principle aim was

Conclusion

Undergoing IBR with TE placement does not confer added risk of wound, medical, or overall morbidity relative to mastectomy alone based upon propensity-matched 30-day complication rates in 15,238 patients from the 2005–2011 ACS-NSQIP datasets.

Financial support

This particular research received no internal or external grant funding.

Conflicts of interest

The authors report no relevant financial disclosures related to this current work.

Ethical approval

De-identified patient information is freely available to all institutional members who comply with the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Data Use Agreement. The Data Use Agreement implements the protections afforded by the Health Insurance Portability and Accountability Act of 1996.

Disclosure

None of the authors listed have any relevant conflicts of interest to report.

Disclaimer

The ACS-NSQIP and the hospitals participating in the ACS-NSQIP are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors of this study.

IRB

IRB and HIC exemption were obtained by our institutions.

Author role/participation

JPF – conception, data analysis, drafting, critical revisions.

AMW – data analysis, critical revisions.

CTT – data acquisition and management, critical revisions.

JAN – critical revisions.

JCT – conception, critical revisions.

SJK – conception, drafting, critical revisions.

JMS – critical revisions.

LCW – conception, critical revisions.

Acknowledgments

We would like to acknowledge and thank Nancy Folsom, BSN for her assistance in the organization and preparation of the IRB for this study.

References (36)

  • J.P. Fischer et al.

    Comprehensive outcome and cost analysis of free tissue transfer for breast reconstruction: an experience with 1303 flaps

    Plast Reconstr Surg

    (2013)
  • Y. Cemal et al.

    A paradigm shift in U.S. breast reconstruction: Part 2. The influence of changing mastectomy patterns on reconstructive rate and method

    Plast Reconstr Surg

    (2013)
  • C.R. Albornoz et al.

    A paradigm shift in U.S. breast reconstruction: increasing implant rates

    Plast Reconstr Surg

    (2013)
  • J.P. Fischer et al.

    A 30-day risk assessment of mastectomy alone compared to immediate breast reconstruction (IBR)

    J Plast Surg Hand Surg

    (2014)
  • R.G. Reish et al.

    Infection following implant-based reconstruction in 1952 consecutive breast reconstructions: salvage rates and predictors of success

    Plast Reconstr Surg

    (2013)
  • A.K. Alderman et al.

    Complications in postmastectomy breast reconstruction: two-year results of the Michigan breast reconstruction outcome study

    Plast Reconstr Surg

    (2002)
  • P.J. Hanwright et al.

    The differential effect of BMI on prosthetic versus autogenous breast reconstruction: a multivariate analysis of 12,986 patients

    Breast

    (2013)
  • K.Y. Lin et al.

    An outcome study of breast reconstruction: presurgical identification of risk factors for complications

    Ann Surg Oncol

    (2001)
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