Analysis Of The NSQIP Database in 19,100 Patients: How Does Acellular Dermal Matrix Affect Complication Rates In Implant Based Breast Reconstruction?

Title: Analysis of the NSQIP Database in 19,100 Patients: How Does Acellular Dermal Matrix Affect Complication Rates in Implant Based Breast Reconstruction

Authors: Ahmed M. S. Ibrahim, MD, Marina Shuster, BA, Pieter G. L. Koolen, MD, Kuylhee Kim, MD, Amir H. Taghinia, MD, Hani H. Sinno, MD, MENG, Bernard T. Lee, MD, MBA, Samuel J. Lin, MD

Division of Plastic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School

Purpose:

The use of acellular dermal matrices (ADMs) by plastic surgeons has become increasingly popular in immediate and delayed tissue expander/ implant based breast reconstruction. (1) However, it is unclear whether ADM use increases postoperative complication rates. (2-5) We conducted a controlled evaluation of patients with and without the use of ADMs in implant based breast reconstruction using the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database. We aimed to assess baseline differences in demographics and co-morbidities between the two cohorts and to determine whether postoperative complication rates varied.

Materials and Methods:

Using the ACS NSQIP database we extracted tissue expander implant breast reconstruction cases using unique Current Procedural Terminology (CPT) codes. Differences in preoperative demographics and co-morbidities were assessed using chi-square and t-test analysis in SPSS. We also analyzed variations in complication rates and determined whether demographics and co-morbidities affected outcomes via multivariate analysis using logistic regression and a power analysis.

Results:

Out of 19,100 cases 3,301 involved ADM use. Overall complication rates were not statistically significant (5.3% ADM versus 4.9% non-ADM, p=0.396). Several risk factors served as statistically significant associated factors in complications, primarily in the non-ADM group. BMI was associated with the development of wound complications in both the ADM and non-ADM cohorts (p=0.04 and p=0.02 respectively). Furthermore, along with smoking (p=0.02) and diabetes (p=0.03), BMI (p=0.01) was also associated with major complications in the non-ADM group. Minor complications were primarily associated with radiotherapy in the last 90 days (p=0.01) as well as chronic steroid use (p=0.02). In the ADM group, dyspnea was an associated factor for the development of both major and minor complications (p=0.04). A post hoc power analysis found with an alpha of .05 and a power (beta) of 80% our study had sufficient sample size.

Conclusion:

ADM use does not appear to increase complication rates in tissue expander implant breast reconstruction. There was no significant difference in complication rates between the ADM and non-ADM groups. Several co-morbidities serve as associated factors for negative outcomes in both groups.

References:

1. Maxwell, G. P., Gabriel, A. Use of the acellular dermal matrix in revisionary aesthetic breast surgery. Aesthet Surg J 29: 485-493, 2009.
2. Liu, A. S., Kao, H. K., Reish, R. G., et al. Postoperative complications in prosthesis-based breast reconstruction using acellular dermal matrix. Plast Reconstr Surg 127: 1755-1762, 2011.
3. Komorowska-Timek, E., Oberg, K. C., Timek, T. A., et al. The effect of AlloDerm envelopes on periprosthetic capsule formation with and without radiation. Plast Reconstr Surg 123: 807-816, 2009.
4. Bindingnavele, V., Gaon, M., Ota, K. S., et al. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction. J Plast Reconstr Aesthet Surg 60: 1214-1218, 2007.
5. Chun, Y. S., Verma, K., Rosen, H., et al. Implant-based breast reconstruction using acellular dermal matrix and the risk of postoperative complications. Plast Reconstr Surg 125: 429-436, 210.

 

Table 1. Demographics of the immediate or delayed tissue expander/implant based breast reconstruction cohort
N=19,100		Total	ADM group	Non-ADM group	P-Value
Gender	Female Male Unreported	18,997(99.5%) 51 (0.3%) 52 (0.3%)	3,283 (99.5%) 8 (0.2%) 10 (0.3%)	15,714 (99.5%) 43 (0.3%) 42 (0.2%)	0.763
Race	White African American/Black Asian Hispanic American Indian/Alaska Native Native Hawaiian/Pacific Islander Unknown/Unreported	15,167(79.4%) 1,227 (6.4%) 538 (2.8%) 130 (0.1%) 27 (0.1%) 45 (0.2%) 1,966 (10.3%)	2,740(83.0%) 187(5.7%) 96(2.9%) 9(0.3%) 4(0.1%) 5(0.2%) 260(7.9%)	12.427(78.7%) 1,040(6.6%) 442(2.8%) 121(0.8%) 23(0.1%) 37(0.2%) 1,736(11.0%)	0.003
Age (in years)		51.2±10.7	50.7±10.6	51.3±10.8	0.004
Year of reconstruction	2011 2010 2009 2008 2007 2005-2006	5,323 (27.9%) 4,355 (22.8%) 3,713 (19.4%) 2,753 (14.4%) 1,914 (10.0%) 1,042 (5.5%)	1,230 (32.3%) 820 (24.8%) 548 (16.6%) 417 (12.6%) 211 (6.4%) 75 (2.3%)	4,093 (25.9%) 3,535 (22.4%) 3,165 (20.0%) 2,336 (14.8%) 1,703 (10.8%) 967 (6.1%)	<0.001
Type of reconstruction	Immediate implant (19340) Delayed implant (19342) Tissue expander placement (19357) Immediate implant + Tissue expander (19340 + 19357) Delayed implant + Tissue expander (19342 + 19357) Immediate implant + Delayed implant (19340 + 19342) Immediate implant + Delayed implant + Tissue expander (19340 + 19342 + 19357)	3,429 (18.0%) 1,101 (5.8%) 14,314(74.9%) 183 (1%)  21 (0.1%)  51 (0.3%)  1 (0.005%)	356 (10.8%) 44 (1.3%) 2,865 (86.8%)  32 (1.0%) 2 (0.1%)  2 (0.1%)  0 (0%)	3,073 (19.5%) 1,057 (6.7%) 11,449 (72.5%)  151 (1.0%)  19 (0.1%)  49 (0.3%)  1(0.006%)	<0.001

 

 

 

 

 

 

 

Table 2. Statistically significant predictors of complication groups
Complication	ADM group	Non-ADM group
Major Complications	Dyspnea (p=0.04)	Diabetes (p=0.03) Smoking (p=0.02) BMI (p=0.01, O.R. 1.037) Prior transient ischemic attack (p=0.01) Operation within 30 days (p=0.01) Blood transfusion (p=0.003)
Wound Complications	BMI (p=0.04, O.R. 1.060) Asian (p=0.01)	History of Chronic Obstructive Pulmonary Disease (p=0.03) Bleeding disorder (p=0.004) BMI (p=0.002, O.R. 1.035) White (p=0.05)
Minor Complications	Dyspnea (p=0.04)	Radiotherapy in the last 90 days (p=0.01) Chronic Steroid use (p=0.02) Prior CVA/stroke (p=0.05)

O.R. : Odds ratio