Results: Summary Tables for Outcomes

Ian J. Saldanha; Wangnan Cao; Justin M. Broyles; Gaelen P. Adam; Monika Reddy Bhuma; Shivani Mehta; Laura S. Dominici; Andrea L. Pusic; Ethan M. Balk

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Saldanha IJ, Cao W, Broyles JM, et al. Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 Jul. (Comparative Effectiveness Review, No. 245.)

Appendix EResults: Summary Tables for Outcomes

Table E-1.1Summary Table – Key Question 1: IBR versus AR – continuous outcomes (general quality of life, psychosocial well-being, sexual well-being, patient satisfaction with breasts, and patient satisfaction with outcome)

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Measurement	Time Point	Subgroup	IBR, N	IBR, Mean (SD)	AR, N	AR, Mean (SD)	AR Versus IBR, Effect Size (95% CI)	P Value
Kouwenberg, 2019, 30270015, Netherlands	NRCS	Moderate	General QoL	EQ-5D-5L utilities score (0–1)	NR	All	67	0.85 (0.18)	67	0.87 (0.14)	NR	0.7
Kouwenberg, 2020, 32590633, Netherlands	NRCS	Moderate	General QoL	EQ-5D-5L utilities score (0–1)	>6 mo	All	296	0.85 (0.30)	179	0.85 (0.20)	NR	NS
	NRCS	Moderate	General QoL	EQ-5D-5L VAS (0–100)	>6 mo	All	296	77.6 (18.4)	179	79.2 (16.7)	NR	NS
	NRCS	Moderate	General QoL	EORTC QLQC30: Global health status (0–100)	>6 mo	All	296	80.2 (18.4)	179	81.4 (14.7)	NR	NS
Roth, 2007, 17413877, US	NRCS	High	General QoL	FACT-B: Functional well-being (0–28)	2 y	All	35	23.3 (NR)	55	24.1 (NR)	NR	NS
	NRCS	High	General QoL	SF-36: Role emotional (0–100)	2 y	All	35	86.7 (NR)	55	86.1 (NR)	NR	NS
	NRCS	High	General QoL	SF-36: Vitality (0–100)	2 y	All	35	65.7 (NR)	55	62.4 (NR)	NR	NS
	NRCS	High	General QoL	SF-36: General mental health (0–100)	2 y	All	35	77.6 (NR)	55	77 (NR)	NR	NS
	NRCS	High	General QoL	Body Image (9–45)	2 y	All	35	32.5 (NR)	55	35.3 (NR)	NR	NS
Tallroth, 2020, 33436336, Sweden	RCT	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	5.3 y	All	28	78.8 (20.1)	42	79.1 (21.5)	MD 0.3 (−6.7, 7.3)	0.93
Eltahir, 2015, 25539295, Netherlands	NRCS	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	2.2 y	All	45	77.2 (18.1)	47	74.0 (17.8)	adjMD 4.6 (−2.8, 12.0)	0.22
Eltahir, 2015, 25539295, Netherlands	NRCS	Moderate	Psychosocial WB	SF-36: Social functioning (0–100)	2.2 y	All	NR	NR	NR	NR	adjMD −1.21 (−8.44, 6.02)	0.74
Kouwenberg, 2020, 32590633, Netherlands	NRCS	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	>6 mo	All	296	71.6 (20.2)	179	75.8 (19.5)	NR	<0.05
	NRCS	Moderate	Psychosocial WB	EORTC QLQC30: Social function (0–100)	>6 mo	All	296	87.5 (27.2)	179	88.0 (17.1)	NR	NS
	NRCS	Moderate	Psychosocial WB	EORTC QLQC30: Emotional function (0–100)	>6 mo	All	296	85.0 (23.3)	179	87.0 (17.1)	NR	NS
	NRCS	Moderate	Psychosocial WB	EORTC QLQC30: Cognitive function (0–100)	>6 mo	All	296	85.0 (23.7)	179	83.7 (21.5)	NR	NS
	NRCS	Moderate	Psychosocial WB	EORTC QLQC30: Role function (0–100)	>6 mo	All	296	86.0 (28.1)	179	84.0 (21.8)	NR	<0.05
Kulkarni, 2017, 28713853, US & Canada	NRCS	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	1 y	All	791	71.8 (19)	386	74.7 (19.2)	adjMD 3.70 (0.73, 6.76)	0.015
	NRCS	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	2 y	All	1490	74.5 (18.9)	523	75.8 (19)	adjMD 3.27 (1.25, 5.29)	NR
	NRCS	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	2 y	Unilateral	600	74.6 (18.7)	317	76.8 (18.9)	adjMD 3.84 (NR)	NR
	NRCS	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	2 y	Bilateral	994	74.5 (19)	224	73.4 (19)	adjMD 0.91 (NR)	NR
	NRCS	Moderate	Psychosocial WB	PROMIS: Anxiety (0–100)	1 y	All	775	49.7 (9.4)	383	50.4 (9.6)	adjMD 0.70 (−0.75, 2.08)	0.36
	NRCS	Moderate	Psychosocial WB	PROMIS: Depression (0–100)	1 y	All	776	47.3 (8)	385	47.9 (8.2)	adjMD 0.40 (−0.70, 1.45)	0.50
Roth, 2007, 17413877, US	NRCS	High	Psychosocial WB	FACT-B: Social/ family WB (0–28)	2 y	All	35	19.3 (NR)	55	20.3 (NR)	NR	0.24
Roth, 2007, 17413877, US	NRCS	High	Psychosocial WB	SF-36: Social functioning (0–100)	2 y	All	35	87.9 (NR)	55	87.7 (NR)	NR	≥0.05
Tallroth, 2020, 33436336, Sweden	RCT	Moderate	Sexual WB	BREAST-Q: Sexual well-being (0–100)	5.3 y	All	28	58.4 (23.1)	42	67.1 (28.1)	MD 8.7 (0.2, 17.2)	0.046
Eltahir, 2015, 25539295, Netherlands	NRCS	Moderate	Sexual WB	BREAST-Q: Sexual well-being (0–100)	2.2 y	All	45	61.14 (24.17)	47	60.89 (20.82)	adjMD 6.44 (−3.56, 16.5)	0.20
Kouwenberg, 2020, 32590633, Netherlands	NRCS	Moderate	Sexual WB	BREAST-Q: Sexual well-being (0–100)	>6 mo	All	296	56.4 (30.7)	179	63.3 (30.4)	NR	<0.05
	NRCS	Moderate	Sexual WB	EORTC QLQBR23: Sexual functioning (0–100)	>6 mo	All	296	33.4 (29.4)	179	32.0 (27.3)	NR	<0.05
	NRCS	Moderate	Sexual WB	EORTC QLQBR23: Sexual enjoyment (0–100)	>6 mo	All	296	63.8 (32.5)	179	64.2 (33.8)	NR	NS
Kulkarni, 2017, 28713853, US & Canada	NRCS	Moderate	Sexual WB	BREAST-Q: Sexual WB (0–100)	1 y	All	756	53 (21.1)	370	55.4 (19.8)	adjMD 4.50 (1.52, 7.48)	0.003
	NRCS	Moderate	Sexual WB	BREAST-Q: Sexual WB (0–100)	2 y	All	1490	53.9 (21.3)	523	57.1 (21.7)	adjMD 5.53 (−2.95, 8.11)	NR
	NRCS	Moderate	Sexual WB	BREAST-Q: Sexual WB (0–100)	2 y	Unilateral	600	52.8 (20.5)	317	58.9 (20.6)	adjMD 11.42 (NR)	<0.001
	NRCS	Moderate	Sexual WB	BREAST-Q: Sexual WB (0–100)	2 y	Bilateral	994	54.7 (21.5)	214	54.4 (23)	adjMD 4.2 (NR)	<0.001
Tallroth, 2020, 33436336, Sweden	RCT	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	5.3 y	All	28	63.4 (11.8)	42	72.1 (17.7)	MD 8.7 (3.8, 13.6)	0.001
Tallroth, 2020, 33436336, Sweden	RCT	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with nipples (0–100)	5.3 y	All	28	65.4 (21.8)	42	67.7 (24.9)	MD 2.3 (−5.5, 10.1)	0.56
Brito, 2020, No PMID, Portugal	NRCS	High	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	NR	All	68	56.3 (17.1)	111	64.1 (17.1)	NR	0.004
Eltahir, 2015, 25539295, Netherlands	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2.2 y	All	45	65.51 (17.55)	47	75.19 (17.09)	adjMD 8.16 (1.18, 15.2)	0.023
Eltahir, 2015, 25539295, Netherlands	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with nipples (0–100)	2.2 y	All	45	63.62 (33.99)	47	65.31 (27.82)	adjMD 1.70 (−14.2, 17.6)	0.83
Kouwenberg, 2020, 32590633, Netherlands	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	>6 mo	All	296	59.4 (19.3)	179	71.3 (17.7)	NR	<0.05
Kouwenberg, 2020, 32590633, Netherlands	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with nipples (0–100)	>6 mo	All	296	55.0 (48.7)	179	63.0 (29.0)	NR	<0.05
Kulkarni, 2017, 28713853, US & Canada	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	1 y	All	795	64.0 (16.8)	388	67.8 (17.2)	adjMD 6.30 (3.41, 9.09)	<0.001
	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2 y	All	1490	64.2 (18)	523	68.5 (18.3)	adjMD 7.94 (5.68, 10.2)	NR
	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2 y	Unilateral	600	61.2 (18)	317	68.3 (18.1)	adjMD 9.85 (NR)	0.001
	NRCS	Moderate	Satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2 y	Bilateral	994	66.1 (17.7)	214	68.9 (18.6)	adjMD 5.13 (2.07, 8.17)^*	0.001
Tallroth, 2020, 33436336, Sweden	RCT	Moderate	Satisfaction with outcome	BREAST-Q: Satisfaction with outcome (0–100)	5.3 y	All	28	79.4 (14.2)	42	82.3 (21.4)	MD 2.9 (−3.1, 8.9)	0.34
Eltahir, 2015, 25539295, Netherlands	NRCS	Moderate	Satisfaction with outcome	BREAST-Q: Satisfaction with outcome (0–100)	2.2 y	All	45	74.5 (19.0)	47	81.8 (18.7)	adjMD 4.9 (−3.1, 12.9)	0.23
Kouwenberg, 2020, 32590633, Netherlands	NRCS	Moderate	Satisfaction with outcome	BREAST-Q: Satisfaction with outcome (0–100)	>6 mo	All	296	66.4 (23.7)	179	75.8 (22.2)	NR	<0.05

: Abbreviations: adj = adjusted, CI = confidence interval, QoL = quality of life, MD = mean difference, mo = months, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RCT = randomized controlled trial, RoB = risk of bias, SD = standard deviation, VAS = Visual Analog Scale, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: Confidence interval calculated based on the reported P value.

Table E-1.2Summary Table – Key Question 1: IBR versus AR – continuous outcomes (physical well-being)

Study, Year, PMID, Country	Design	Overall RoB	Outcome Measurement	Time Point	Group	Subgroup	N	Mean (SD)	Effect Size (95% CI)	P Value
Tallroth, 2020, 33436336, Sweden	RCT	Moderate	BREAST-Q: Chest (0–100)	5.3 y	IBR	All	28	72.0 (21.5)	Ref	Ref
Tallroth, 2020, 33436336, Sweden	RCT	Moderate	BREAST-Q: Chest (0–100)	5.3 y	AR	All	42	79.6 (21.1)	MD 7.6 (0.3, 14.9)	0.041
Eltahir, 2015, 25539295, Netherlands	NRCS	Moderate	BREAST-Q: Physical WB (0–100)	2.2 y	IBR	All	45	71.89 (15.06)	Ref	Ref
	NRCS	Moderate	BREAST-Q: Physical WB (0–100)	2.2 y	AR	All	47	77.13 (17.11)	adjMD −2.60 (−9.77, 4.57)	0.47
	NRCS	Moderate	SF-36: Physical function (0–100)	2.2 y	IBR	All	45	NR	Ref	Ref
	NRCS	Moderate	SF-36: Physical function (0–100)	2.2 y	AR	All	NR	NR	adjMD 2.13 (−4.20, 8.46)	0.51
Kouwenberg, 2020, 32590633, Netherlands	NRCS	Moderate	BREAST-Q: Chest (0–100)	>6 mo	IBR	All	296	72.6 (17.8)	Ref	Ref
	NRCS	Moderate	BREAST-Q: Chest (0–100)	>6 mo	AR	All	179	75.8 (15.4)	NR	<0.05
	NRCS	Moderate	EORTC QLQC30 (0–100)	>6 mo	IBR	All	296	88.0 (20.6)	Ref	Ref
	NRCS	Moderate	EORTC QLQC30 (0–100)	>6 mo	AR	All	179	85.6 (15.7)	NR	<0.05
Kulkarni, 2017, 28713853, US & Canada	NRCS	Moderate	BREAST-Q: Chest (0–100)	1 y	IBR (all)	All	791	76.7 (14.5)	Ref	Ref
	NRCS	Moderate	BREAST-Q: Chest (0–100)	1 y	AR (all)	All	386	74.9 (15.1)	adjMD 1.60 (−0.57, 3.68)	0.003
	NRCS	Moderate	BREAST-Q: Chest (0–100)	2 y	IBR (all)	All	NR	NR	NR	NR
	NRCS	Moderate	BREAST-Q: Chest (0–100)	2 y	IBR (all)	Unilateral	600	77.2 (13.8)	NR	NR
	NRCS	Moderate	BREAST-Q: Chest (0–100)	2 y	IBR (all)	Bilateral	994	77.3 (14.6)	NR	NR
	NRCS	Moderate	BREAST-Q: Chest (0–100)	2 y	AR (all)	All	NR	NR	NR	NR
	NRCS	Moderate	BREAST-Q: Chest (0–100)	2 y	AR (all)	Unilateral	317	76.3 (15.4)	vs. IBR (Unilateral): adjMD 1.77 (−1.17, 4.71)^*	0.24
	NRCS	Moderate	BREAST-Q: Chest (0–100)	2 y	AR (all)	Bilateral	224	74.5 (15.4)	vs. IBR (Bilateral): adjMD 0.57 (−1.40, 2.54)^*	0.57
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	IBR (all)	All	1490	NR	NR	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	IBR DTI	All	93	NR	Ref	Ref
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	IBR TE	All	1263	NR	Ref	Ref
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	AR (all)	All	1523	75.6 (15.4)	vs. IBR (all): adjMD 1.69 (0.13, 3.24)	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	AR with DIEP	All	350	NR	vs. IBR (TE): adjMD −1.44 (−4.11, 1.23)^*	0.29
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	AR with free TRAM	All	87	NR	vs. IBR (TE): adjMD −0.62 (−4.78, 3.54)^*	0.77
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	AR with pedicled TRAM	All	77	NR	vs. IBR (TE): adjMD −3.93 (−8.15, 0.29)^*	0.068
	NRCS	Moderate	PROMIS: Pain interference (0–100)	2 y	IBR (all)	All	773	46 (7.5)	Ref	Ref
	NRCS	Moderate	PROMIS: Pain interference (0–100)	2 y	AR (all)	All	384	48.4 (8.4)	adjMD 1.10 (0.01, 2.25)	0.048
	NRCS	Moderate	PROMIS: Physical function (0–100)	1 y	IBR (all)	All	777	52.2 (6.8)	Ref	Ref
	NRCS	Moderate	PROMIS: Physical function (0–100)	1 y	AR (all)	All	385	50.1 (7.2)	adjMD −0.60 (−1.51, 0.39)	0.25
	NRCS	Moderate	PROMIS: Physical function (0–100)	2 y	IBR (all)	All	NR	NR	NR	NR
	NRCS	Moderate	PROMIS: Physical function (0–100)	2 y	IBR (all)	Unilateral	600	52.6 (6.5)	NR	NR
	NRCS	Moderate	PROMIS: Physical function (0–100)	2 y	IBR (all)	Bilateral	994	52.8 (6.3)	NR	NR
	NRCS	Moderate	PROMIS: Physical function (0–100)	2 y	AR (all)	All	NR	NR	NR	NR
	NRCS	Moderate	PROMIS: Physical function (0–100)	2 y	AR (all)	Unilateral	317	51.3 (7.3)	vs. IBR (unilateral): adjMD −0.14 (−1.42, 1.14)^*	0.83
	NRCS	Moderate	PROMIS: Physical function (0–100)	2 y	AR (all)	Bilateral	214	49.8 (7.6)	vs. IBR (bilateral): adjMD −1.21 (−2.47, 0.05)^*	0.06
McCarthy, 2014, 24201740, US	NRCS	Moderate	BREAST-Q: Physical WB (0–100)	1–5 y	IBR	All	141	76.5 (16)	Ref	Ref
McCarthy, 2014, 24201740, US	NRCS	Moderate	BREAST-Q: Physical WB (0–100)	1–5 y	AR	All	74	82.5 (15.3)	NR	<0.05

: Abbreviations: adj = adjusted, CI = confidence interval, DIEP = deep inferior epigastric perforator, DTI = direct to implant, MD = mean difference, mo = months, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, PROMIS: Patient Reported Outcomes Measurement Information System, RCT = randomized controlled trial, Ref = reference group, RoB = risk of bias, SD = standard deviation, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate study are shaded blue. The colors do not add unique information.
*: Confidence interval calculated based on the reported P value.

Table E-1.3Summary Table – Key Question 1: IBR versus AR – NRCSs, categorical outcomes (physical well-being and recurrence of breast cancer)

Study, Year, PMID, Country	Overall RoB	Outcome	Outcome Measurement	Time Point	IBR, n/N (%)	AR, n/N (%)	Adjusted Odds Ratio (95% CI)	P Value
Nelson, 2019, 31356276, US	High	Physical WB	Higher BREAST-Q: Chest	1 y	NR/1342 (NR)	NR/194 (NR)	0.96 (0.67, 1.38)	NS
	High	Physical WB	Higher BREAST-Q: Chest	3 y	NR/1085 (NR)	NR/98 (NR)	1.4 (0.83, 2.34)	NS
	High	Physical WB	Higher BREAST-Q: Chest	5 y	NR/743 (NR)	NR/41 (NR)	4.52 (2.03, 10.1)	<0.001
	High	Physical WB	Higher BREAST-Q: Chest	7 y	NR/377 (NR)	NR/19 (NR)	3.08 (1.03, 9.15)	0.043
Ha, 2020, 32000718, South Korea	High	Breast cancer recurrence	High histologic grade (Grade III) breast cancer	4.8 y	14/247 (5.7)	24/249 (9.6)	3.39 (1.23, 9.32)	0.018
Ha, 2020, 32000718, South Korea	High	Breast cancer recurrence	Locoregional breast cancer	4.8 y	9/247 (3.6)	11/249 (4.4)	NR	0.70
Kouwenberg, 2020, 32590633, Netherlands	Moderate	Breast cancer recurrence	Local recurrence	>6 mo	13/296 (4.5	7/179 (4.0)	0.89 (0.35, 2.26)	0.25
Kouwenberg, 2020, 32590633, Netherlands	Moderate	Breast cancer recurrence	Distant recurrence	>6 mo	13/296 (4.5)	8/179 (4.6)	1.02 (0.41, 2.51)	0.97
Wu, 2021, 33740204, South Korea	High	Breast cancer recurrence	NR	5.8 y	29/138 (21.0)	64/276 (23.2)	NR	0.62

: Abbreviations: AR = autologous reconstruction, CI = confidence interval, mo = months, NR = not reported, NRCS = nonrandomized comparative study, NS = not significant, PMID = PubMed identifier, RoB = risk of bias, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-1.4Summary Table – Key Question 1: IBR versus AR – NRCSs, categorical outcomes (patient satisfaction with breasts and with outcome)

Study, Year, PMID, Country	Overall RoB	Outcome Measurement	Time Point	Group	n/N (%)	Comparison	Adjusted Odds Ratio (95% CI)	P Value
Lei, 2020, 32481367, China	High	Satisfied with breasts	2 mo	IBR	NR	Ref	Ref	Ref
Lei, 2020, 32481367, China	High	Satisfied with breasts	2 mo	AR	NR	vs. IBR	0.85 (0.36, 1.63)	0.40
Yueh, 2009, 19228537, US	High	Satisfied with breasts	NR	IBR	42/87 (48.3)	Ref	Ref	Ref
	High	Satisfied with breasts	NR	AR	NR/389 (NR)	vs. IBR	1.43 (1.18, 1.73)	NR
	High	Satisfied with breasts	NR	AR with TRAM	102/143 (71.3)	vs. IBR	3.49 (1.91, 6.40)	NR
	High	Satisfied with breasts	NR	AR with LD	68/112 (60.7)	vs. IBR	1.99 (1.09, 3.65)	NR
Lei, 2020, 32481367, China	High	Satisfied with surgical outcome	2 mo	IBR	NR	Ref	Ref	Ref
Lei, 2020, 32481367, China	High	Satisfied with surgical outcome	2 mo	AR	NR	vs. IBR	0.69 (0.45, 1.67)	0.33
Yueh, 2009, 19228537, US	High	Satisfied with surgical outcome	NR	IBR	49/87 (56.3)	Ref	Ref	Ref
	High	Satisfied with surgical outcome	NR	AR	NR/389 (NR)	vs. IBR	1.83 (1.11, 3.03)	NR
	High	Satisfied with surgical outcome	NR	AR with TRAM	98/143 (68.5)	vs. IBR	2.05 (1.13, 3.72)	NR
	High	Satisfied with surgical outcome	NR	AR with LD	63/112 (56.3)	vs. IBR	1.12 (0.64, 2.12)	NR

: Abbreviations: AR = autologous reconstruction, CI = confidence interval, DIEP = deep inferior epigastric perforator, LD = latissimus dorsi, mo = months, RCT = randomized controlled trial, PMID = PubMed identifier, Ref = reference group, RoB = risk of bias, TRAM = transverse rectus abdominis myocutaneous. Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-1.5Summary Table – Key Question 1: IBR versus AR – categorical outcomes, mortality, unplanned repeat hospitalizations, necrosis, thromboembolic events, wound dehiscence, delayed healing, seroma, and hematoma

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Description	Time Point	IBR n/N (%)	AR n/N (%)	Adjusted Odds Ratio (95% CI) for AR versus IBR	P Value
Jiang, 2013, 24349366, US	NRCS	High	Mortality	Overall mortality	8.9 y	241/1412 (17.1)	503/2649 (19.0)	0.96 (0.89, 1.04)	NR
Jiang, 2013, 24349366, US	NRCS	High	Mortality	Breast cancer-specific mortality	8.9 y	209/1412 (14.8)	432/2649 (16.3)	0.95 (0.87, 1.04)	NR
Merchant, 2015, 26111325, US	NRCS	High	Unplanned repeat hospitalizations	Any unplanned readmission	1 mo	338/10437 (3.24)	95/2329 (4.08)	1.07 (0.95, 1.20)	NR
Mioton, 2013, 23562485, US	NRCS	Moderate	Unplanned repeat hospitalizations	Any unplanned readmission	1 mo	172/3960 (4.34)	56/1052 (5.32)	NR	NS
Nasser, 2018, 30204678	NRCS	High	Unplanned repeat hospitalizations	Unplanned ED visits	1 mo	NR/28124 (NR)	NR/4773 (NR)	1.11 (0.91, 1.25)	0.18
Nasser, 2018, 30204678	NRCS	High	Unplanned repeat hospitalizations	Unplanned ED visits with pain-related diagnosis	1 mo	NR/28124 (NR)	NR/4773 (NR)	1.11 (0.83, 1.67)	0.41
Abedi, 2016, 25003437, Canada	NRCS	High	Necrosis	Mastectomy flap necrosis	1.6–1.9 y	70/606 (11.6)	60/395 (15.2)	0.66 (0.38, 1.16)	0.15
de Araujo, 2016, 27673527, US	NRCS	High	Necrosis	Major mastectomy flap necrosis	4.3 y	NR/38 (NR)	NR/32 (NR)	17.9 (0.52, 610.5)	0.11
Naoum, 2020a, 31756414, US	NRCS	High	Necrosis	Mastectomy flap necrosis	4–10 y	26/633 breasts (4.1)	16/342 breasts (4.7)	0.83 (0.19, 3.50)	0.8
Naoum, 2020a, 31756414, US	NRCS	High	Necrosis	Fat necrosis	4–10 y	1/633 breasts (0.2)	24/342 breasts (7.0)	21.2 (2.5, 174.5)	0.004
Woo, 2018, 30360958, South Korea	NRCS	High	Necrosis	Mastectomy flap necrosis	NR	14/60 (23.3)	7/70 (10)	0.31 (0.11, 0.86)	0.02
Brorson 2020a, 32807615, Sweden	RCT	High	Thromboembolic events	DVT	1 mo	0/66 (0)	0/51 (0)	No events	N/A
Brorson 2020a, 32807615, Sweden	RCT	High	Thromboembolic events	PE	1 mo	1/66 (1.5)	0/51 (0)	Not calculable (no events in AR group)	Not calculable
Tallroth, 2020, 3346336, Sweden	RCT	Moderate	Thromboembolic events	DVT	1 mo	1/28 (3.6)	0/42 (0)	Not calculable (no events in AR group)	Not calculable
	RCT	Moderate	Thromboembolic events	Arterial stop	1 mo	0/28 (0)	2/42 (4.8)	Not calculable (no events in IBR group)	Not calculable
	RCT	Moderate	Thromboembolic events	Venous stasis	1 mo	0/28 (0)	6/42 (14.3)	Not calculable (no events in IBR group)	Not calculable
Mioton, 2013, 23562485, US	NRCS	Moderate	Thromboembolic events	DVT	1 mo	27/9786 (0.28)	20/3296 (0.61)	0.99 (0.41, 2.41)	NR
Mioton, 2013, 23562485, US	NRCS	Moderate	Thromboembolic events	PE	1 mo	17/9786 (0.17)	17/3296 (0.52)	1.84 (0.71, 4.77)	NR
Momeni, 2018, 29095189, US	NRCS	High	Thromboembolic events	DVT or PE	3 mo	65/16851 (3.85)	815/4622 (17.63)	2.27 (1.79, 2.86)	NR
Garvey, 2012, 23096600, US	NRCS	Moderate	Wound dehiscence	NR	1.5 y	28/442 breasts (6.3)	25/548 breasts (4.6)	NR	0.25
Mioton, 2013, 23562485, US	NRCS	Moderate	Wound dehiscence	Wound disruption	1 mo	44^*/9786 (0.44)	41^*/3296 (1.24)	1.79 (0.83, 3.84)	NR
Fischer, 2013, 23629074, US	NRCS	High	Delayed healing	Delayed breast wound healing	4 y	9/60 (15)	52/142 (36.6)	2.2 (1.0, 5.2)	0.06
Garvey, 2012, 23096600, US	NRCS	Moderate	Delayed healing	NR	1.5 y	19/442 breasts (4.3)	41/548 breasts (7.5)	NR	0.01
Fischer, 2014, 24916480, US	NRCS	High	Seroma	Breast seroma	1.8–2.1 y	13/155 (8.1)	4/155 (2.8)	NR	0.009
Garvey, 2012, 23096600, US	NRCS	Moderate	Seroma	Breast seroma or hematoma	1.5 y	61/442 breasts (13.8)	27/548 breasts (4.9)	NR	<0.001
Fischer, 2014, 24916480, US	NRCS	High	Hematoma	Breast hematoma	1.8–2.1 mo	4/155 (2.4)	4/155 (2.8)	NR	1.0

: Abbreviations: AR = autologous reconstruction, CI = confidence interval, DVT = deep vein thrombosis, ED = emergency department, IBR = implant-based reconstruction, N/A = not applicable, NR = not reported, NRCS = nonrandomized comparative study, PE = pulmonary embolism, PMID = PubMed identifier, RoB = risk of bias, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: calculated

Table E-1.6Summary Table – Key Question 1: IBR versus AR – NRCSs, categorical outcomes (unplanned repeat surgeries for revision, unplanned repeat surgeries for complications, pain, infections not explicitly implant related, and reconstructive failure)

Study, Year, PMID, Country	Overall RoB	Outcome	Outcome Description	Time Point	Group	Subgroup	n/N (%)	Adjusted Odds Ratio (95% CI)	P Value
Fischer, 2014, 24916480, US	High	Unplanned repeat surgery for revision	Unplanned revision	<6 mo	IBR	All	8/155 (5.2)	Ref	Ref
	High	Unplanned repeat surgery for revision	Unplanned revision	<6 mo	AR	All	6/155 (3.9)	NR	0.56
	High	Unplanned repeat surgery for revision	Unplanned revision	<1 y	IBR	All	17/155 (11.0)	Ref	Ref
	High	Unplanned repeat surgery for revision	Unplanned revision	<1 y	AR	All	7/155 (4.5)	NR	0.017
	High	Unplanned repeat surgery for revision	Unplanned revision	<2 y	IBR	All	21/155 (13.5)	Ref	Ref
	High	Unplanned repeat surgery for revision	Unplanned revision	<2 y	AR	All	7/155 (4.5)	NR	0.003
Kulkarni, 2017, 28713853, US & Canada	Moderate	Unplanned repeat surgery for revision	Unplanned revision	2 y	IBR DTI	All	31/93 (33.3)	-	-
	Moderate	Unplanned repeat surgery for revision	Unplanned revision	2 y	IBR TE	All	503/1263 (39.8)	Ref	Ref
	Moderate	Unplanned repeat surgery for revision	Unplanned revision	2 y	AR with DIEP	All	223/350 (63.7)	vs. IBR with TE: 2.66 (1.83, 3.86)	<0.001
	Moderate	Unplanned repeat surgery for revision	Unplanned revision	2 y	AR with free TRAM	All	56/87 (64.4)	vs. IBR with TE: 2.26 (1.35, 3.78)	0.002
	Moderate	Unplanned repeat surgery for revision	Unplanned revision	2 y	AR with pedicled TRAM	All	40/77 (57.1)	vs. IBR with TE: 1.34 (0.75, 2.40)	0.33
	Moderate	Unplanned repeat surgery for revision	Unplanned revision	2 y	AR with LD	All	41/64 (64.1)	vs. IBR with TE: 1.97 (1.07, 3.64)	0.031
	Moderate	Unplanned repeat surgery for revision	Unplanned revision	2 y	AR with SIEA	All	33/62 (53.2)	vs. IBR with TE: 1.83 (0.93, 3.60)	0.079
Zhang, 2019, 30675702, China	High	Unplanned repeat surgery for revision	Unplanned reoperation	4.9 y	IBR	All	230/394 (58.4)	Ref	Ref
Zhang, 2019, 30675702, China	High	Unplanned repeat surgery for revision	Unplanned reoperation	4.9 y	AR	All	154/438 (35.2)	vs. IBR: 0.72 (0.50, 1.06)	0.093
Hangge, 2013, 31606126, US	High	Unplanned repeat surgery for complications	NR	NR	IBR DTI	All	81/193 (42)	vs. AR: 2.03 (1.03, 3.98)	0.042
	High	Unplanned repeat surgery for complications	NR	NR	IBR TE	All	58/146 (40)	vs. AR: 1.81 (0.90, 3.64)	0.096
	High	Unplanned repeat surgery for complications	NR	NR	AR	All	17/60 (28)	Ref	Ref
Mioton, 2013, 23562485, US	Moderate	Unplanned repeat surgery for complications	NR	1 mo	IBR	All	662/9786 (6.76)	1.08 (0.88, 1.32)	NR
Mioton, 2013, 23562485, US	Moderate	Unplanned repeat surgery for complications	NR	1 mo	AR	All	316/3296 (9.59)	Ref	Ref
Zhang, 2019, 30675702, China	High	Unplanned repeat surgery for complications	Urgent surgery for a compromised implant/flap	4.9 y	IBR	All	31/394 (7.9)	vs. AR: 0.63 (0.29, 1.37)	NR
Zhang, 2019, 30675702, China	High	Unplanned repeat surgery for complications	Urgent surgery for a compromised implant/flap	4.9 y	AR	All	33/438 (7.5)	Ref	Ref
Kulkarni, 2017, 28713853, US & Canada	Moderate	Pain	VAS: Moderate to severe	2 y	IBR DTI	All	NR	-	-
	Moderate	Pain	VAS: Moderate to severe	2 y	IBR TE	All	NR	Ref	Ref
	Moderate	Pain	VAS: Moderate to severe	2 y	AR with DIEP	All	NR	vs. IBR with TE: 1.22 (0.73, 2.04)^*	0.45
	Moderate	Pain	VAS: Moderate to severe	2 y	AR with free TRAM	All	NR	vs. IBR with TE: 1.73 (0.73, 4.08)^*	0.21
	Moderate	Pain	VAS: Moderate to severe	2 y	AR with pedicled TRAM	All	NR	vs. IBR with TE: 1.64 (0.68, 3.95)^*	0.27
	Moderate	Pain	VAS: Moderate to severe	2 y	AR with LD	All	NR	vs. IBR with TE: 0.94 (0.28, 3.14)^*	0.92
	Moderate	Pain	VAS: Moderate to severe	2 y	AR with SIEA	All	NR	vs. IBR with TE: 1.43 (0.57, 3.62)^*	0.45
de Araujo, 2016, 27673527, US	High	Infections not explicitly implant-related	SSI	4.3 y	IBR	All	NR/38 (NR)	vs. AR 0.86 (0.18, 4.11)	0.847
de Araujo, 2016, 27673527, US	High	Infections not explicitly implant-related	SSI	4.3 y	AR	All	NR/32 (NR)	Ref	Ref
Garvey, 2012, 23096600, US	Moderate	Infections not explicitly implant-related	Infections	1.5 y	IBR	All	50/442 breasts (11.3)	Ref	Ref
Garvey, 2012, 23096600, US	Moderate	Infections not explicitly implant-related	Infections	1.5 y	AR	All	21/548 breasts (3.8)	vs. IBR: NR	<0.001
Kulkarni, 2017, 28713853, US & Canada	Moderate	Infections not explicitly implant-related	Breast WI	2 y	IBR	All	NR	NR	NR
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	IBR DTI	All	17/112 (15.2)	-	-
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	IBR TE	All	159/1525 (10.4)	Ref	Ref
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	AR (all)	All	NR	NR	NR
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	AR with DIEP	All	27/390 (6.9)	vs IBR TE: 0.44 (0.25, 0.78)	0.005
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	AR with free TRAM	All	5/95 (5.3)	vs IBR TE: 0.45 (0.17, 1.18)	0.10
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	AR with pedicled TRAM	All	8/85 (9.4)	vs IBR TE: 0.73 (0.31, 1.70)	0.46
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	AR with LD	All	6/71 (8.5)	vs IBR TE: 0.50 (0.15, 1.56)	0.23
	Moderate	Infections not explicitly implant-related	Breast WI	2 y	AR with SIEA	All	8/65 (12.3)	vs IBR TE: 0.67 (0.25, 1.82)	0.43
Mioton, 2013, 23562485, US	Moderate	Infections not explicitly implant-related	WI	1 mo	IBR	All	338/9786 (3.45)	Ref	Ref
	Moderate	Infections not explicitly implant-related	WI	1 mo	AR	All	180/3296 (5.46)	vs IBR: 1.40 (1.01, 1.96)	NR
	Moderate	Infections not explicitly implant-related	Superficial SSI	1 mo	IBR	All	163/9786 (1.67)	Ref	Ref
	Moderate	Infections not explicitly implant-related	Superficial SSI	1 mo	AR	All	97/3296 (2.95)	vs IBR: 1.20 (0.81, 1.76)	NR
	Moderate	Infections not explicitly implant-related	Deep SSI	1 mo	IBR	All	195/9786 (1.07)	Ref	Ref
	Moderate	Infections not explicitly implant-related	Deep SSI	1 mo	AR	All	65/3296 (1.97)	vs IBR: 1.81 (1.12, 2.94)	NR
Naoum, 2020a, 31756414, US	High	Infections not explicitly implant-related	NR	4–10 y	IBR	All	23/633 breasts (3.6)	Ref	Ref
Naoum, 2020a, 31756414, US	High	Infections not explicitly implant-related	NR	4–10 y	AR	All	9/342 breasts (2.6)	vs IBR: 0.77 (0.20, 2.50)	0.67
Naoum, 2020b, 32607638, US	High	Infections not explicitly implant-related	NR	4.3–6.3 y	IBR DTI	All	7/127 (5.5)	Ref	Ref
	High	Infections not explicitly implant-related	NR	4.3–6.3 y	IBR with TE	All	2/88 (2.2)	Ref	Ref
	High	Infections not explicitly implant-related	NR	4.3–6.3 y	AR	All	11/85 (13.0)	vs. IBR DTI: 3.2 (0.6, 16) vs. IBR with TE: 8.1 (1.7, 39)	0.20 0.009
Chetta, 2017, 28002254, US	High	Reconstructive failure	NR	1.3 mo	IBR	All	1101/3746 (29.4)	Ref	Ref
Chetta, 2017, 28002254, US	High	Reconstructive failure	NR	1.3 mo	AR	All	40/935 (4.3)	vs IBR: 0.09 (0.07, 0.13)	<0.001
Fischer, 2013, 23629074, US	High	Reconstructive failure	Unplanned, nonaesthetic TE/I removal related to a complication	4 y	IBR	All	4/60 (7.3)	Ref	Ref
Fischer, 2013, 23629074, US	High	Reconstructive failure	Flap loss	4 y	AR	All	2/142 (1.3)	vs IBR: 0.19 (0.04, 0.80)	0.03
Garvey, 2012, 23096600, US	Moderate	Reconstructive failure	NR	1.5 y	IBR	All	70/442 breasts (15.8)	Ref	Ref
Garvey, 2012, 23096600, US	Moderate	Reconstructive failure	NR	1.5 y	AR	All	8/548 breasts (1.5)	vs IBR: NR	<0.001
Kulkarni, 2017, 28713853, US & Canada	Moderate	Reconstructive failure	NR	2 y	IBR (all)	All	NR	Ref	Ref
	Moderate	Reconstructive failure	NR	2 y	IBR (all)	Unilateral	41/600 (6.83)	NR	NR
	Moderate	Reconstructive failure	NR	2 y	IBR (all)	Bilateral	74/994 (7.44)	NR	NR
	Moderate	Reconstructive failure	NR	2 y	AR (all)	All	NR	NR	NR
	Moderate	Reconstructive failure	NR	2 y	AR (all)	Unilateral	4/317 (1.26)	vs. IBR (all): 0.12 (0.04, 0.36)	<0.001
	Moderate	Reconstructive failure	NR	2 y	AR (all)	Bilateral	4/224 (1.87)	vs. IBR (all): 0.14 (0.05, 0.45)	0.001
Mioton, 2013, 23562485, US	Moderate	Reconstructive failure	Implant or flap failure	1 mo	IBR	All	83/9786 (0.85)	Ref	Ref
Mioton, 2013, 23562485, US	Moderate	Reconstructive failure	Implant or flap failure	1 mo	AR	All	103/3296 (3.13)	vs. IBR: 1.69 (1.08, 2.62)	NR

: Abbreviations: adj = adjusted, AR = autologous reconstruction, CI = confidence interval, DIEP = deep inferior epigastric perforator, DTI = direct to implant, IBR = implant-based reconstruction, LD = latissimus dorsi, mo = months, N/A = not applicable, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, Ref = reference group, RoB = risk of bias, SIEA = superficial inferior epigastric artery, SSI = surgical site infection, TE = tissue expander, TRAM = transverse rectus abdominis myocutaneous, VAS = Visual Analog Scale, WI = wound infection, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: Confidence interval calculated based on the reported P value.

Table E-1.7Summary Table – Key Question 1: IBR versus AR – NRCSs, continuous outcomes (pain and analgesic use)

Study, Year, PMID, Country	Outcome	Outcome Measurement	Overall RoB	Time Point	Group	N	Mean (SD)	Adjusted Mean Difference (95% CI)	P Value
Eltahir, 2015, 25539295, Netherlands	Pain	SF-36: Pain (0–100)	Moderate	2.2 y	IBR	NR	NR	Ref	Ref
Eltahir, 2015, 25539295, Netherlands	Pain	SF-36: Pain (0–100)	Moderate	2.2 y	AR	NR	NR	vs. IBR: 2.40 (−5.37, 10.2)	0.54
Kouwenberg, 2020, 32590633, Netherlands	Pain	EORTC QLQC30 Pain (0–100)	Moderate	>6 mo	IBR	296	15.9 (26.3)	Ref	Ref
Kouwenberg, 2020, 32590633, Netherlands	Pain	EORTC QLQC30 Pain (0–100)	Moderate	>6 mo	AR	179	17.2 (27.2)	NR	NS
Kulkarni, 2017, 28713853, US & Canada	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	IBR (all)	1846	NR	Ref	Ref
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	IBR Direct	NR	NR	NR	NR
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	IBR TE	NR	NR	NR	NR
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	AR (all)	463	NR	NR	NR
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	AR with DIEP	111	NR	vs. IBR (all): −1.20 (−2.11, −0.29)^*	0.01
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	AR with free TRAM	94	NR	vs. IBR (all): 0.26 (−1.16, 1.69)^*	0.72
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	AR with pedicled TRAM	NR	NR	vs. IBR (all): −1.04 (−2.53, 0.45)^*	0.17
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	AR with LD	80	NR	vs. IBR (all): 0.35 (−1.37, 2.07)^*	0.69
	Pain	MPQ-SF: Sensory (0–10)	Moderate	1 w	AR with SIEA	73	NR	vs. IBR (all): 2.41 (0.38, 4.44)^*	0.02
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	IBR (all)	NR	NR	NR	NR
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	IBR Direct	96	4.2 (NR)	-	-
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	IBR TE	1329	5.7 (NR)	Ref	Ref
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	AR (all)	NR	NR	NR	NR
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	AR with DIEP	296	4.8 (NR)	vs. IBR TE: 1.10 (0.35, 1.85)^*	0.004
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	AR with free TRAM	83	6.7 (NR)	vs. IBR TE: 2.48 (NR)	<0.001
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	AR with pedicled TRAM	91	5 (NR)	vs. IBR TE: 1.19 (−0.14, 2.52)^*	0.08
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	AR with LD	62	5.4 (NR)	vs. IBR TE: 0.42 (−1.19, 2.03)^*	0.61
	Pain	MPQ-SF: Sensory (0–10)	Moderate	3 mo	AR with SIEA	56	NR	vs. IBR TE: 2.37 (0.81, 3.94)^*	0.003
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	IBR (all)	1846	NR	Ref	Ref
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	IBR Direct	NR	NR	NR	NR
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	IBR TE	NR	NR	NR	NR
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	AR (all)	NR	NR	NR	NR
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	AR with DIEP	463	NR	vs. IBR (all): 0.24 (−0.10, 0.58)^*	0.16
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	AR with free TRAM	111	NR	vs. IBR (all): 0.37 (−0.15, 0.89)^*	0.16
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	AR with pedicled TRAM	94	NR	vs. IBR (all): −0.01 (−0.79, 0.77)^*	0.98
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	AR with LD	80	NR	vs. IBR (all): 0.47 (−0.17, 1.11)^*	0.15
	Pain	MPQ-SF: Affective (0–10)	Moderate	1 w	AR with SIEA	73	NR	vs. IBR (all): −0.03 (−0.97, 0.91)	0.95
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	IBR (all)	1263	NR	NR	NR
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	IBR Direct	93	NR	-	-
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	IBR TE	1263	NR	Ref	Ref
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	AR (all)	NR	NR	NR	NR
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	AR with DIEP	350	NR	vs. IBR TE: 0.33 (0.07, 0.59)^*	0.013
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	AR with free TRAM	87	NR	vs. IBR TE: 0.84 (NR)	<0.001
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	AR with pedicled TRAM	77	NR	vs. IBR TE: 0.04 (−0.47, 0.55)^*	0.877
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	AR with LD	64	NR	vs. IBR TE: −0.13 (−0.66, 0.40)^*	0.63
	Pain	MPQ-SF: Affective (0–10)	Moderate	2 y	AR with SIEA	62	NR	vs. IBR TE: 1.24 (NR)	<0.0001
	Pain	VAS (0–10)	Moderate	1 w	IBR (all)	1846	NR	Ref	Ref
	Pain	VAS (0–10)	Moderate	1 w	IBR Direct	NR	NR	NR	NR
	Pain	VAS (0–10)	Moderate	1 w	IBR TE	NR	NR	NR	NR
	Pain	VAS (0–10)	Moderate	1 w	AR (all)	NR	NR	NR	NR
	Pain	VAS (0–10)	Moderate	1 w	AR with DIEP	463	NR	vs. IBR (all): −0.18 (−0.49, 0.13)^*	0.25
	Pain	VAS (0–10)	Moderate	1 w	AR with free TRAM	111	NR	vs. IBR (all): −0.19 (−0.68, 0.30)^*	0.45
	Pain	VAS (0–10)	Moderate	1 w	AR with pedicled TRAM	94	NR	vs. IBR (all): −0.72 (−1.27, −0.17)^*	0.01
	Pain	VAS (0–10)	Moderate	1 w	AR with LD	80	NR	vs. IBR (all): 0.01 (−0.51, 0.53)^*	0.97
	Pain	VAS (0–10)	Moderate	1 w	AR with SIEA	73	NR	vs. IBR (all): 0.21 (−0.42, 0.84)^*	0.51
Roth, 2007, 17413877, US	Pain	VAS: Bodily pain (1–5)	High	2 y	IBR	48	2.2 (1.2)	Ref	Ref
	Pain	VAS: Bodily pain (1–5)	High	2 y	AR	159	2.2 (1.2)	vs IBR: NR	NS
	Pain	VAS: Breast pain (1–5)	High	2 y	IBR	48	2.1 (1.3)	Ref	Ref
	Pain	VAS: Breast pain (1–5)	High	2 y	AR	159	1.8 (1.1)	vs IBR: NR	NS
	Pain	VAS: Abdominal pain (1–5)	High	2 y	IBR	48	4.8 (0.8)	Ref	Ref
	Pain	VAS: Abdominal pain (1–5)	High	2 y	AR	159	4.0 (1.2)	vs IBR: NR	<0.0001
	Pain	VAS: Back pain (1–5)	High	2 y	IBR	48	4.0 (1.3)	Ref	Ref
	Pain	VAS: Back pain (1–5)	High	2 y	AR	159	3.7 (1.5)	vs IBR: NR	NS
Shiraishi, 2020, 32589082, Japan	Pain	MPQ-SF: Total (0–10)	High	1 y	IBR	56	NR	Ref	Ref
	Pain	MPQ-SF: Total (0–10)	High	1 y	AR	34	NR	1.08 (NR, NR)	NR
	Pain	MPQ-SF: Sensory (0–10)	High	1 y	IBR	56	NR	Ref	Ref
	Pain	MPQ-SF: Sensory (0–10)	High	1 y	AR	34	NR	0.80 (NR, NR)	NR
	Pain	MPQ-SF: Affective (0–10)	High	1 y	IBR	56	NR	Ref	Ref
	Pain	MPQ-SF: Affective (0–10)	High	1 y	AR	34	NR	0.28 (NR, NR)	NR
Shiraishi, 2020, 32589082, Japan	Analgesic use	Analgesic use score (0–5)	High	1 y	IBR	56	NR	Ref	Ref
Shiraishi, 2020, 32589082, Japan	Analgesic use	Analgesic use score (0–5)	High	1 y	AR	34	NR	0.37 (NR, NR)	NR

: Abbreviations: adj = adjusted, CI = confidence interval, DIEP = deep inferior epigastric perforator, LD = latissimus dorsi, MPQ-SF = McGill Pain Questionnaire-Short Form, MD = mean difference, MOS SF = Medical Outcomes Study Short Form, MPQ-SF = McGill Pain Questionnaire Short Form, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, Ref = reference group, RoB = risk of bias, SD = standard deviation, SIEA = superficial inferior epigastric artery, TE = tissue expander, TRAM = transverse rectus abdominis myocutaneous, VAS = Visual Analog Scale.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: Confidence interval calculated based on the reported P value.

Table E-2.1Summary Table – Key Question 2b: Timing of IBR in relation to radiation therapy – NRCSs, continuous outcomes (various)

Study, Year, PMID, Country	Overall RoB	Outcome	Outcome Measurement	Time Point	IBR Before Radiation, N	IBR Before Radiation, Mean (SD)	IBR After Radiation, N	IBR After Radiation, Mean (SD)	IBR Before Versus After Radiation, Adjusted MD (95% CI)	P Value
Cordeiro, 2015, 30270015, US	High	Physical WB	BREAST-Q: Physical WB (0–100)	3.3 y	84	72.5 (2.6)	22	73.4 (1.9)	NR	NS
Yoon, 2020, 32332528, US & Canada	Moderate	Physical WB	BREAST-Q: Physical WB (0–100)	2 y	80	NR	237	NR	−0.64 (−7.19, 5.90)	0.84
Yoon, 2020, 32332528, US & Canada	Moderate	Physical WB	PROMIS: Physical function (0–100)	2 y	80	NR	237	NR	−0.04 (−2.40, 2.32)	0.97
Cordeiro, 2015, 30270015, US	High	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	3.3 y	84	71.1 (1.4)	22	72.3 (1.2)	NR	<0.01
Yoon, 2020, 32332528, US & Canada	Moderate	Psychosocial WB	BREAST-Q: Psychosocial WB (0–100)	2 y	80	NR	237	NR	0.48 (−7.72, 8.68)	0.91
Cordeiro, 2015, 30270015, US	High	Sexual WB	BREAST-Q: Sexual WB (0–100)	3.3 y	84	54.0 (0.9)	22	55.4 (0.7)	NR	<0.01
Yoon, 2020, 32332528, US & Canada	Moderate	Sexual WB	BREAST-Q: Sexual WB (0–100)	2 y	80	NR	237	NR	−1.00 (−8.41, 6.40)	0.78
Yoon, 2020, 32332528, US & Canada	Moderate	Sexual WB	EORTC: Sexual function	2 y	80	NR	237	NR	−1.40 (−8.58, 5.77)	0.70
Cordeiro, 2015, 30270015, US	High	Satisfaction with breast	BREAST-Q: Satisfaction with breast (0–100)	3.3 y	84	56.2 (3.3)	22	57.2 (3.1)	NR	NS
Yoon, 2020, 32332528, US & Canada	Moderate	Satisfaction with breast	BREAST-Q: Satisfaction with breast (0–100)	2 y	80	NR	237	NR	−3.89 (−11.0, 3.23)	0.28
Cordeiro, 2015, 30270015, US	High	Satisfaction with outcome	BREAST-Q: Satisfaction with outcome (0–100)	3.3 y	84	68.4 (3.8)	22	70.2 (3.0)	NR	0.02
Yoon, 2020, 32332528, US & Canada	Moderate	Pain	PROMIS: Pain interference (0−100)	2 y	80	NR	237	NR	2.86 (−1.05, 6.77)	0.14

: Abbreviations: CI = confidence interval, EORTC = European Organization for Research and Treatment of Cancer, IBR = implant-based reconstruction, NR = not reported, NRCS = nonrandomized comparative study, NS = not significant, PMID = PubMed identifier, PROMIS = Patient-Reported Outcomes Measurement Information System, RoB = risk of bias, SD = standard deviation, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-2.2Summary Table – Key Question 2b: Timing of IBR in relation to radiation therapy – NRCSs, categorical outcomes (various)

Study, Year, PMID, Country	Overall RoB	Outcome	Outcome Measurement	Time Point	IBR Before Radiation (%)	IBR After Radiation (%)	Effect Size (95% CI) Before Versus After Radiation	P Value
Eriksson, 2013, 24258257, Sweden	High	Unplanned repeat surgeries for revision	NR	3.6 y	NR	NR	adjHR 0.94 (0.63, 1.40)	NR
Hirsch, 2014, 25347643, US	High	Necrosis	NR	3.1 y	NR	NR	adjOR 0.96 (0.68, 1.35)	0.94
Yoon, 2020, 32332528, US & Canada	Moderate	Infections (not explicitly implant-related)	Major (IV antibiotics)	2 y	5/46 (10.9%)	7/104 (6.7%)	NR	0.40
Yoon, 2020, 32332528, US & Canada	Moderate	Infections (not explicitly implant-related)	Minor (oral antibiotics)	2 y	3/46 (6.5%)	7/104 (6.7%)	NR	0.96
Yoon, 2020, 32332528, US & Canada	Moderate	Wound dehiscence	NR	2 y	0/46 (0%)	5/104 (4.8%)	NR	0.32
Yoon, 2020, 32332528, US & Canada	Moderate	Seroma	NR	2 y	2/46 (4.4%)	8/104 (7.7%)	NR	0.46
Yoon, 2020, 32332528, US & Canada	Moderate	Capsular contracture	NR	2 y	1/46 (2.2%)	3/104 (2.9%)	NR	0.80
Hirsch, 2014, 25347643, US	High	Hematoma	NR	3.1 y	NR	NR	adjOR 0.56 (0.22, 1.45)	0.39
Yoon, 2020, 32332528, US & Canada	Moderate	Hematoma	NR	2 y	1/46 (2.2%)	4/104 (3.9%)	NR	0.63
Hirsch, 2014, 25347643, US	High	Composite/unspecified harms	Any complication	3.5 y	NR	NR	adjOR 0.81 (0.56, 1.17)	NR
	High	Composite/unspecified harms	Operative complications	3.5 y	NR	NR	adjOR 0.92 (0.59, 1.45)	NR
	High	Composite/unspecified harms	Nonoperative complications	3.5 y	NR	NR	adjOR 0.90 (0.60, 1.34)	NR
Stein, 2020, 32561384, Canada	High	Composite/unspecified harms	Any complication	10 mo – 5 y	NR/76 (NR)	NR/54 (NR)	adjOR 0.82 (0.03, 2.19)	0.69
	High	Composite/unspecified harms	Major complications	10 mo – 5 y	NR/76 (NR)	NR/54 (NR)	adjOR 0.62 (0.21, 1.86)	0.40
	High	Composite/unspecified harms	Minor complications	10 mo – 5 y	NR/76 (NR)	NR/54 (NR)	adjOR 1.29 (0.41, 4.03)	0.65
Yoon, 2020, 32332528, US & Canada	Moderate	Composite/unspecified harms	Any complication	2 y	33/80 (41.3)	95/237 (40.1)	NR	0.85
Yoon, 2020, 32332528, US & Canada	Moderate	Composite/unspecified harms	Major complications	2 y	26/80 (32.5)	82/237 (34.6)	NR	0.73

: Abbreviations: adj = adjusted, CI = confidence interval, hosp. = hospitalization, HR = hazard ratio, IBR = implant-based reconstruction, IV = intravenous, NR = not reported, NRCS = nonrandomized comparative study, NS = not significant, OR = odds ratio, PMID = PubMed identifier, RoB = risk of bias, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-3.1Summary Table – Key Question 3: Comparisons of implant materials for IBR – NRCSs, continuous outcomes (general quality of life, physical well-being, psychosocial well-being, sexual well-being, satisfaction with outcome, and satisfaction with breasts)

Study, Year, PMID	RoB	Outcome	Outcome Measurement	Time Point (y)	Silicone, N	Silicone, Mean (SD)	Saline, N	Saline, Mean (SD)	Effect Size (95% CI)	P Value
Macadam, 2010, 20009795, Canada	High	General quality of life	EORTC QLQC30 (0–100): Global health status	2.6–4.5	72	79.9 (18.1)	67	74.9 (20.9)	NR	0.13
	High	Physical WB	BREAST-Q (0–100): Physical WB	2.6–4.5	74	76.2 (14.9)	68	73.4 (16.3)	NR	0.28
	High	Psychosocial WB	BREAST-Q (0–100): Psychosocial WB	2.6–4.5	75	77.6 (18.6)	67	70.8 (18.8)	NR	0.03
	High	Sexual WB	BREAST-Q (0–100): Sexual WB	2.6–4.5	71	54.4 (19.8)	65	47.6 (20.9)	NR	0.056
	High	Satisfaction with outcome	BREAST-Q (0–100): Satisfaction with outcome	2.6–4.5	75	75.4 (17.6)	68	69.5 (22.6)	NR	0.082
	High	Satisfaction with breasts	BREAST-Q (0–100): Satisfaction with breast	2.6–4.5	75	63.8 (15.2)	67	56.9 (15.1)	NR	0.008
McCarthy, 2010, 21136577, US & Canada	High	Satisfaction with breasts	BREAST-Q (0–100): Satisfaction with breast	2.4–3.3	176	58.0 (20.3)	306	52.5 (20.4)	adjMD 4.1 (1.31^, 6.89^)	0.004

: Abbreviations: adj = adjusted, CI = confidence interval, EORTC QLQC3 = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, IBR = implant-based reconstruction, MD = mean difference, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RoB = risk of bias, SD = standard deviation, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: Calculated.

Table E-3.2Summary Table – Key Question 3: Comparisons of implant materials for IBR – NRCSs, categorical outcomes (mortality, implant failure/loss, and capsular contracture)

Study, Year, PMID, Country	Overall RoB	Outcome	Outcome Measurement	Time Point (y)	Implant Material	n/N (%)	Effect Size (95% CI)	P Value
Le, 2005, 15743498, US	High	Mortality	Breast cancer mortality	12.4	Silicone	NR	Ref	Ref
	High	Mortality	Breast cancer mortality	12.4	Saline	NR	vs. Silicone: adjHR 1.01 (0.44, 2.34)	NR
	High	Mortality	Breast cancer mortality	12.4	Double lumen	NR	vs. Silicone: adjHR 1.49 (0.83, 2.70)	NR
	High	Mortality	Non-breast cancer mortality	12.4	Silicone	NR	Ref	Ref
	High	Mortality	Non-breast cancer mortality	12.4	Saline	NR	vs. Silicone: adjHR 1.75 (0.29, 10.39)	NR
	High	Mortality	Non-breast cancer mortality	12.4	Double lumen	NR	vs. Silicone: adjHR 3.13 (0.91, 10.78)	NR
Cordeiro, 2015a, 25742523, US	High	Implant failure/loss	TE and implant loss	3.3	Silicone	NR/159	adjOR 0.61 (0.36, 1.07)	NS
Cordeiro, 2015a, 25742523, US	High	Implant failure/loss	TE and implant loss	3.3	Saline	NR/129	Ref	Ref
Antony, 2014, 24135689, US	High	Capsular contracture	Baker Grade III or IV	3–5	Silicone	NR/179	Ref	Ref
Antony, 2014, 24135689, US	High	Capsular contracture	Baker Grade III or IV	3–5	Saline	NR/166	NR	NS

: Abbreviations: adj = adjusted, CI = confidence interval, IBR = implant-based reconstruction, HR = hazard ratio, NR = not reported, NRCS = nonrandomized comparative study, NS = not significant, OR = odds ratio, PMID = PubMed identifier, Ref = reference group, RoB = risk of bias, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-4.1Summary Table – Key Question 4: Comparisons of anatomic planes of implant placement for IBR – continuous outcomes (various)

Study, Year, PMID, Country	Design	RoB	Outcome	Outcome Measurement	Time Point	Arm	N	Mean (SD)	Effect Size (95% CI)	P Value
Lee, 2021b, 33691448, South Korea	RCT	Moderate	Physical WB	SF-36 (0–100): PCS	6 mo	Prepectoral	20	45.2 (7.1)	Ref	Ref
Lee, 2021b, 33691448, South Korea	RCT	Moderate	Physical WB	SF-36 (0–100): PCS	6 mo	Partial Submuscular	14	45.2 (7.1)	NR	0.689
Cattelani, 2018, 29275104, Italy	NRCS	High	Physical WB	Constant Murley (0–100): Upper limb	1 d	Prepectoral	39	71.6 (8.9)	Ref	Ref
	NRCS	High	Physical WB	Constant Murley (0–100): Upper limb	1 d	Total Submuscular	45	60.4 (10.5)	NR	<0.001
	NRCS	High	Physical WB	Constant Murley (0–100): Upper limb	7 d	Prepectoral	39	65.7 (9.3)	Ref	Ref
	NRCS	High	Physical WB	Constant Murley (0–100): Upper limb	7 d	Total Submuscular	45	52.4 (12.2)	NR	<0.001
	NRCS	High	Physical WB	DASH (0–100)	1 y	Prepectoral	39	9.9 (17.9)	Ref	Ref
	NRCS	High	Physical WB	DASH (0–100)	1 y	Total Submuscular	45	29.2 (16.9)	NR	<0.001
Lee, 2021b, 33691448, South Korea	RCT	Moderate	Psychosocial WB	SF-36 (0–100): MCS	6 mo	Prepectoral	20	40.5 (10.5)	Ref	Ref
	RCT	Moderate	Psychosocial WB	SF-36 (0–100): MCS	6 mo	Partial Submuscular	14	40.5 (10.5)	NR	0.904
	RCT	Moderate	Psychosocial WB	HADS: Anxiety (0–21)	6 mo	Prepectoral	20	6.3 (3.3)	Ref	Ref
	RCT	Moderate	Psychosocial WB	HADS: Anxiety (0–21)	6 mo	Partial Submuscular	14	5.0 (2.9)	NR	0.959
	RCT	Moderate	Psychosocial WB	HADS: Depression (0–21)	6 mo	Prepectoral	20	7.5 (7.4)	Ref	Ref
	RCT	Moderate	Psychosocial WB	HADS: Depression (0–21)	6 mo	Partial Submuscular	14	6.3 (3.8)	NR	0.924
Cattelani, 2018, 29275104, Italy	NRCS	High	Psychosocial WB	Return to usual work	NR	Prepectoral	39	34.6 d (21)	Ref	Ref
Cattelani, 2018, 29275104, Italy	NRCS	High	Psychosocial WB	Return to usual work	NR	Total Submuscular	45	57.3 d (37.8)	NR	<0.001
Cattelani, 2018, 29275104, Italy	NRCS	High	Satisfaction with breasts	BREAST-Q (0–100): Satisfaction with breast	1 y	Prepectoral	39	92.2 (9.0)	Ref	Ref
Cattelani, 2018, 29275104, Italy	NRCS	High	Satisfaction with breasts	BREAST-Q (0–100): Satisfaction with breast	1 y	Total Submuscular	45	76.1 (14.6)	NR	<0.001
Avila, 2020, 33234947, US	NRCS	High	Pain	VAS (0–10)	NR	Prepectoral	73	3.94 (0.83)	Ref	Ref
Avila, 2020, 33234947, US	NRCS	High	Pain	VAS (0–10)	NR	Total Submuscular	73	5.25 (0.81)	NR	<0.001
Cattelani, 2018, 29275104, Italy	NRCS	High	Pain	BPI-SF (0–100)	1 d	Prepectoral	39	17.6 (15.5)	Ref	Ref
	NRCS	High	Pain	BPI-SF (0–100)	1 d	Total Submuscular	45	44.1 (15.8)	NR	<0.001
	NRCS	High	Pain	BPI-SF (0–100)	7 d	Prepectoral	39	8.2 (15.4)	Ref	Ref
	NRCS	High	Pain	BPI-SF (0–100)	7 d	Total Submuscular	45	22.0 (18.6)	NR	<0.001
Kim, 2020, 33066236, South Korea	NRCS	Moderate	Pain	VAS (0–10)	1 d	Prepectoral	53	2.66 (1.82)	Ref	Ref
	NRCS	Moderate	Pain	VAS (0–10)	1 d	Partial Submuscular	114	2.26 (1.38)	adjMD −0.08	0.33
	NRCS	Moderate	Pain	VAS (0–10)	7 d	Prepectoral	53	1.08 (1.19)	Ref	Ref
	NRCS	Moderate	Pain	VAS (0–10)	7 d	Partial Submuscular	114	0.80 (1.07)	−0.12	0.12
Avila, 2020, 33234947, US	NRCS	High	Analgesic use	Oral morphine equivalents	NR	Prepectoral	73	17.4 mg (45.1)	Ref	Ref
Avila, 2020, 33234947, US	NRCS	High	Analgesic use	Oral morphine equivalents	NR	Total Submuscular	73	63.0 mg (44.9)	NR	0.03

: Abbreviations: adj = adjusted, BPI-SF = Brief Pain Inventory Short Form, CI = confidence interval, d = days, DASH = Disabilities of the Arm, Shoulder, and Hand, HADS = Hospital Anxiety and Depression Scale, IBR = implant-based reconstruction, MCS = Mental Component Summary, NR = not reported, NRCS = nonrandomized comparative study, PCS = Physical Component Summary, PMID = PubMed identifier, Ref = reference, RoB = risk of bias, SD = standard deviation, SF = Short Form, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-4.2Summary Table – Key Question 4: Comparisons of anatomic planes of implant placement for IBR – categorical outcomes (various)

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Measurement	Time Point	Arm	n/N (%)	Effect Size (95% CI)	P Value
Avila, 2020, 33234947, US	NRCS	High	Unplanned repeat surgeries for revision	NR	1 mo	Prepectoral	8/203 (3.94)	Ref	Ref
Avila, 2020, 33234947, US	NRCS	High	Unplanned repeat surgeries for revision	NR	1 mo	Total submuscular	17/202 (8.42)	NR	NS
Nealon, 2020a, 32032345, US	NRCS	High	Necrosis	Skin necrosis	1.7–2.4 y	Prepectoral	5/114 (4.4)	Ref	Ref
Nealon, 2020a, 32032345, US	NRCS	High	Necrosis	Skin necrosis	1.7–2.4 y	Total submuscular	6/142 (4.2)	adjOR 1.01 (0.74, 5.95)	0.77
Kraenzlin, 2021, 32568752, US	NRCS	High	Infections (not explicitly implant-related)	NR	NR	Prepectoral	34/169 (11.0)	Ref	Ref
Kraenzlin, 2021, 32568752, US	NRCS	High	Infections (not explicitly implant-related)	NR	NR	Total submuscular	34/117 (17.4)	NR	0.21
Nealon, 2020a, 32032345, US	NRCS	High	Infections (not explicitly implant-related)	NR	1.7–2.4 y	Prepectoral	2/114 (1.8)	Ref	Ref
Nealon, 2020a, 32032345, US	NRCS	High	Infections (not explicitly implant-related)	NR	1.7–2.4 y	Total submuscular	6/142 (4.2)	adjOR 0.31 (<0.01, 8.65)	0.52
Nealon, 2020a, 32032345, US	NRCS	High	Need for explant surgery	NR	1.7–2.4 y	Prepectoral	4/114 (3.5)	Ref	Ref
Nealon, 2020a, 32032345, US	NRCS	High	Need for explant surgery	NR	1.7–2.4 y	Total submuscular	7/142 (4.9)	adjOR 1.01 (0.07, 14.1)	0.99
Lee, 2021b, 33691448, South Korea	RCT	Moderate	Capsular contracture	NR	6 mo	Prepectoral	1/20 (5.0)	Ref	Ref
Lee, 2021b, 33691448, South Korea	RCT	Moderate	Capsular contracture	NR	6 mo	Partial submuscular	0/14 (0)	Not calculable	-
Nealon, 2020a, 32032345, US	NRCS	High	Capsular contracture	NR	1.7–2.4 y	Prepectoral	2/114 (1.8)	Ref	Ref
Nealon, 2020a, 32032345, US	NRCS	High	Capsular contracture	NR	1.7–2.4 y	Total submuscular	12/142 (8.5)	adjOR 0.30 (0.03, 1.55)	0.16
Lee, 2021b, 33691448, South Korea	RCT	Moderate	Seroma	NR	6 mo	Prepectoral	3/20 (15.0)	Ref	Ref
Lee, 2021b, 33691448, South Korea	RCT	Moderate	Seroma	NR	6 mo	Partial submuscular	2/14 (14.3)	OR 1.06 (0.15, 7.34)	0.95
Nealon, 2020a, 32032345, US	NRCS	High	Seroma	NR	1.7–2.4 y	Prepectoral	10/114 (8.8)	Ref	Ref
Nealon, 2020a, 32032345, US	NRCS	High	Seroma	NR	1.7–2.4 y	Total submuscular	11/142 (7.7)	adjOR 1.49 (0.37, 6.11)	0.57
Nealon, 2020a, 32032345, US	NRCS	High	Hematoma	NR	1.7–2.4 y	Prepectoral	6/114 (5.3)	Ref	Ref
Nealon, 2020a, 32032345, US	NRCS	High	Hematoma	NR	1.7–2.4 y	Total submuscular	7/142 (4.9)	adjOR 5.18 (0.39, 7.05)	0.23
Avila, 2020, 33234947, US	NRCS	High	Composite or unspecified harms	Necrosis/infection, wound dehiscence/hematoma/seroma	1 mo	Prepectoral	12/203 (5.91)	Ref	Ref
Avila, 2020, 33234947, US	NRCS	High	Composite or unspecified harms	Necrosis/infection, wound dehiscence/hematoma/seroma	1 mo	Total submuscular	19/202 (9.41)	NR	NS
Gabriel, 2020, 32195862, US	NRCS	High	Composite or unspecified harms	Any complication	2 y	Prepectoral	19/129 breasts (14.7)	Ref	Ref
Gabriel, 2020, 32195862, US	NRCS	High	Composite or unspecified harms	Any complication	2 y	Partial submuscular	33/128 breasts (25.8)	adjOR 3.04 (1.34, 7.61)	0.013
Ozgur, 2020, 33223365, Turkey	NRCS	High	Composite or unspecified harms	Capsular contracture, inframammary fold problems, bottoming out, rippling, mechanical shift, animation deformity	5.3–6.1 y	Partial submuscular	8/91 breasts (8.8)	Ref	Ref
Ozgur, 2020, 33223365, Turkey	NRCS	High	Composite or unspecified harms	Capsular contracture, inframammary fold problems, bottoming out, rippling, mechanical shift, animation deformity	5.3–6.1 y	Total submuscular	29/117 breasts (24.8)	adjOR 3.28 (1.39, 7.76)	0.007

: Abbreviations: adj = adjusted, CI = confidence interval, IBR = implant-based reconstruction, HR = hazard ratio, mo = months, NR = not reported, NRCS = nonrandomized comparative study, NS = not significant, OR = odds ratio, PMID = PubMed identifier, RoB = risk of bias, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-5.1Summary Table – Key Question 5: Use versus nonuse of human ADMs during IBR – continuous outcomes (physical well-being, psychosocial well-being, sexual well-being, and satisfaction with breasts)

Study, Year, PMID, Country	Outcome	Outcome Measurement	Design	Overall RoB	Time Point	Use of ADM, N	Use of ADM, Mean (SD)	Nonuse of ADM, N	Nonuse of ADM, Mean (SD)	Effect Size (95% CI)	P Value
McCarthy, 2012, 23096987, US	Physical WB	BREAST-Q (0–100): Chest and upper body	RCT	Moderate	Expansion	36	68.6 (10.6)	33	69.3 (7.9)	NMD 0.60 (−4.87, 6.07)^*	0.83
McCarthy, 2012, 23096987, US	Physical WB	BREAST-Q (0–100): Chest and upper body	RCT	Moderate	After expansion	36	79.7 (15.1)	33	80.5 (13.3)	NMD 0.50 (−5.93, 6.93)^*	0.88
Cattelani, 2018, 29275104, Italy	Physical WB	Constant Murley Score	NRCS	High	1 d	39	71.62 (8.87)	45	60.36 (10.54)	NR	<0.001
	Physical WB	Constant Murley Score	NRCS	High	7 d	39	65.67 (9.31)	45	52.36 (12.23)	NR	<0.001
	Physical WB	DASH score	NRCS	High	1 y	39	9.92 (17.87)	45	29.18 (16.91)	NR	<0.001
Ganesh Kumar, 2021, 33172826, US & Canada	Physical WB	BREAST-Q (0–100): Physical well-being	NRCS	Moderate	2 y	738	NR	713	NR	adjMD −0.82 (−3.01, 1.37)	NR
Cattelani, 2018, 29275104, Italy	Psychosocial WB	Return to usual work	NRCS	High	NR	39	34.56 d (21)	45	57.31 d (37.77)	NR	<0.001
Ganesh Kumar, 2021, 33172826, US & Canada	Psychosocial WB	BREAST-Q (0–100): Psychosocial WB	NRCS	Moderate	2 y	738	NR	713	NR	adjMD −0.26 (−2.97, 2.45)	NR
Ganesh Kumar, 2021, 33172826, US & Canada	Sexual WB	BREAST-Q (0–100): Sexual WB	NRCS	Moderate	2 y	738	NR	713	NR	adjMD −2.28 (−5.63, 1.06)	NR
Cattelani, 2018, 29275104, Italy	Satisfaction with breasts	BREAST-Q: Satisfaction with breast	NRCS	High	1 y	39	92.2 (9.03)	45	76.1 (14.6)	NR	<0.001
Ganesh Kumar, 2021, 33172826, US & Canada	Satisfaction with breasts	BREAST-Q: Satisfaction with breast	NRCS	Moderate	2 y	738	NR	713	NR	adjMD −1.95 (−4.96, 1.06)	NR

: Abbreviations: adj = adjusted, ADM = acellular dermal matrix, CI = confidence interval, d = days, DASH = Disabilities of the Arm, Shoulder, and Hand, h = hours, IBR = implant-based reconstruction, MD = mean difference, N/A = not applicable, NMD = net mean difference, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RCT = randomized controlled trial, RoB = risk of bias, SD = standard deviation, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: calculated

Table E-5.2Summary Table – Key Question 5: Use versus nonuse of human ADMs during IBR – categorical outcomes not meta-analyzed (various)

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Measurement	Time Point	Subgroup	Use of ADM, n/N (%)	Nonuse of ADM, n/N (%)	Effect Size (95% CI)	P Value
Wendel, 2013, None, US	RCT	High	Mortality	Death	1 mo	All patients	0/20 (0)	0/16 (0)	No events	N/A
Ibrahim, 2013, 24165587, US	NRCS	Moderate	Unplanned repeat surgeries for revision	NR	6 mo	All patients	237/3283 (0.5)	990/15714 (0.6)	NR	0.14
Nealon, 2020b, 31605310, US	NRCS	High	Unplanned repeat surgeries for revision	NR	5.3 y	All patients	NR	NR	adjOR 0.86 (0.69, 1.08)	0.19
Sobti, 2018, 29481386, US	NRCS	High	Unplanned repeat surgeries for revision	Revision for malposition or size	5 y	All patients	47/465 breasts (10.11)	24/217 breasts (11.06)	adjOR 1.10 (0.63, 1.92)	NR
Peled, 2012, 22634688, US	NRCS	High	Unplanned repeat surgeries for complications	For wound-healing/infectious complication	2.6–3.3 y	All patients	11/100 breasts (11)	21/90 breasts (23.3)	NR	<0.05
Ibrahim, 2013, 24165587, US	NRCS	Moderate	Thromboembolic events	Deep vein thrombosis	NR	All patients	9/3283 (0.3)	35/15714 (0.2)	NR	0.47
Ibrahim, 2013, 24165587, US	NRCS	Moderate	Thromboembolic events	Pulmonary embolism	NR	All patients	2/3283 (0.06)	29/15714 (0.2)	NR	0.11
Craig, 2019, 29800083, US	NRCS	Low	Wound dehiscence	NR	7 mo	All patients	35/574 breasts (6.1)	20/796 breasts (2.5)	NR	NR
	NRCS	Low	Wound dehiscence	NR	7 mo	Postop radiation	42/88 breasts (47.7)	27/113 breasts (23.9)	NR	NR
	NRCS	Low	Wound dehiscence	NR	7 mo	No postop radiation	30/486 breasts (6.2)	17/683 breasts (2.5)	adjOR 2.46 (1.23, 4.93)	NR
Ganesh Kumar, 2021, 33172826, US & Canada	NRCS	Moderate	Wound dehiscence	NR	2 y	All patients	24/738 (3.3)	5/713 (0.7)	NR	0.009
Ibrahim, 2013, 24165587, US	NRCS	Moderate	Wound dehiscence	NR	NR	All patients	15/3283 (0.5)	98/15714 (0.6)	NR	0.26
Qureshi, 2016, 27465177, US	NRCS	High	Wound dehiscence	Dehiscence without necrosis	2 y	All patients	NR/295 (NR)	NR/118 (NR)	adjOR 0.4 (NR, NR)	<0.05
Woo, 2017, 28509694, South Korea	NRCS	High	Delayed healing	Delayed wound healing or skin flap necrosis	NR	All patients	32/199 (16.1)	32/199 (16.1)	adjOR 1.41 (0.67, 2.96)	0.37
Ganesh Kumar, 2021, 33172826, US & Canada	NRCS	Moderate	Implant rupture	Implant rupture, leakage, or deflation	2 y	All patients	11/738 (1.5)	7/713 (1.0)	NR	0.58
Ganesh Kumar, 2021, 33172826, US & Canada	NRCS	Moderate	Implant malposition	NR	2 y	All patients	9/738 (1.2)	4/713 (0.6)	NR	0.83
Vardanian, 2011, 22030500, US	NRCS	High	Implant malposition	NR	2.4 y	All patients	4/208 breasts (1.9)	12/129 breasts (9.3)	adjOR 0.23 (0.06, 0.78)	NR
Seth, 2012, 23018687, US	NRCS	High	Implant extrusion	NR	2 y	All patients	2/199 breasts (1)	9/293 breasts (2.3)	adjOR 0.43 (0.09, 2.02)	NR
Ganesh Kumar, 2021, 33172826, US & Canada	NRCS	Moderate	Capsular contracture	NR	2 y	All patients	14/738 (1.9)	12/713 (1.7)	NR	0.24
Nealon, 2020b, 31605310, US	NRCS	High	Capsular contracture	NR	5.3 y	All patients	NR	NR	adjOR 0.78 (0.46, 1.36)	0.38
Sobti, 2018, 29481386, US	NRCS	High	Capsular contracture	NR	5 y	All patients	21/465 breasts (4.52)	7/217 breasts (3.23)	Nonuse vs use of ADM: adjOR 0.57 (0.23, 1.43)	NR
Vardanian, 2011, 22030500, US	NRCS	High	Capsular contracture	NR	2.4 y	All patients	8/208 breasts (3.8)	25/129 breasts (19.4)	adjOR 0.18 (0.08, 0.43)	NR
Vardanian, 2011, 22030500, US	NRCS	High	Harms to inframammary fold	Inframammary fold issues other than bottoming-out or shifting, but related to the integrity of the fold	2.4 y	All patients	17/208 breasts (8.2)	25/129 breasts (19.4)	adjOR 0.49 (0.23, 1.01)	NR

: Abbreviations: ADM = acellular dermal matrix, CI = confidence interval, d = days, IBR = implant-based reconstruction, N/A = not applicable, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RoB = risk of bias.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-5.3Summary Table – Key Question 5: Use versus nonuse of human ADMs during IBR – continuous outcomes (pain and analgesic use)

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Measurement	Time Point	Use of ADM, N	Use of ADM, Mean (SD)	Nonuse of ADM, N	Nonuse of ADM, Mean (SD)	Effect Size (95% CI)	P Value
McCarthy, 2012, 23096987, US	RCT	Moderate	Pain	Visual analog scale (0–100)	24 h	36	54.6 (27.6)	33	42.8 (24.5)	NMD 6.2 (−4.9, 17.3)^*	0.27
	RCT	Moderate	Pain	Visual analog scale (0–100)	Expansion phase	36	17 (15.9)	33	4.6 (8.9)	NMD 6.8 (1.1, 12.5)^*	0.019
	RCT	Moderate	Pain	Visual analog scale (0–100)	After expansion	36	5.6 (11.6)	33	4.6 (8.9)	NMD −4.6 (−9.8, 0.6)^*	0.081
Cattelani, 2018, 29275104, Italy	NRCS	High	Pain	BPI-SF (0–100)	1 d	39	17.56 (15.52)	45	44.11 (15.83)	NR	<0.001
Cattelani, 2018, 29275104, Italy	NRCS	High	Pain	BPI-SF (0–100)	7 d	39	8.23 (15.39)	45	21.96 (18.59)	NR	<0.001
McCarthy, 2012, 23096987, US	RCT	Moderate	Analgesic use	Oral codeine equivalents	0–6 h	33	228 (153)	30	256 (197)	MD −28 mg (−116, 60)^*	0.77
	RCT	Moderate	Analgesic use	Oral codeine equivalents	6–24 h	33	619 (519)	30	715 (533)	MD −96 mg (−356, 164)^*	0.38
	RCT	Moderate	Analgesic use	Oral codeine equivalents	0–24 h	36	776 (602)	32	910 (634)	MD −134 mg (−440, 172)^*	0.38

: Abbreviations: ADM = acellular dermal matrix, BPI-SF = Brief Pain Inventory-Short Form, CI = confidence interval, d = days, h = hours, IBR = implant-based reconstruction, MD = mean difference, mg = milligrams, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RCT = randomized controlled trial, RoB = risk of bias, SD = standard deviation.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: Calculated.

Table E-5.4Summary Table – Key Question 5: Use versus nonuse of human ADMs during IBR – categorical outcomes (composite or unspecified harms)

Study, Year, PMID, Country	Design	Overall RoB	Outcome Measurement	Time Point	Use of ADM, n/N (%)	Nonuse of ADM, n/N (%)	Effect Size (95% CI)	P Value
Wendel, 2013, None, US	RCT	High	Serious adverse events	1 mo	0/20 (0)	0/16 (0)	N/A	N/A
Brooke, 2012, 22868313, US	NRCS	High	Clinically significant complications, defined as cellulitis, abscess, seroma, expander leak or puncture, skin necrosis, wound dehiscence, or hematoma requiring readmission, reoperation, and/or expander explantation	NR	37/221 breasts (17)	7/64 breasts (11)	NR	0.48
Ganesh Kumar, 2021, 33172826, US & Canada	NRCS	Moderate	Any complication	2 y	211/738 (28.6)	178/713 (25.0)	adjOR 1.21 (0.86, 1.70)	0.26
Ganesh Kumar, 2021, 33172826, US & Canada	NRCS	Moderate	Major complications	2 y	169/738 (22.9)	117/713 (16.4)	adjOR 1.43 (1.00, 2.05)	0.052
Hirsch, 2014, 25347643, US	NRCS	Low	Any complication	3.5 y	NR	NR	adjOR 0.90 (0.60, 1.34)	0.6
	NRCS	Low	Operative complication except explantation	3.5 y	NR	NR	adjOR 0.68 (0.46, 1.02)	0.46
	NRCS	Low	Nonoperative complication	3.5 y	NR	NR	adjOR 0.67 (0.26, 1.74)	0.43
Liu, 2011, 21228744, US	NRCS	High	Surgical complications	NR	52/266 (19.5)	25/204 (12.3)	adjOR 1.76 (1.03, 3.01)	0.036
Safran, 2020, 32221195, Canada	NRCS	High	Any complication, including hematoma, infection, seroma, implant displacement, NAC full-thickness necrosis, superficial cellulitis, red breast syndrome, incision necrosis, delayed healing, hypergranulation, and NAC superficial necrosis.	NR	NR/243 breasts (NR)	NR/70 breasts (NR)	adjOR 1.59 (0.56, 4.50)	NR
Stein, 2020, 32561384, Canada	NRCS	High	Any complication	10 mo – 5 y	16/41 (39.0)	37/89 (42.1)	adjOR 0.86 (0.26, 2.78)	NR
	NRCS	High	Major complications	10 mo – 5 y	10/41 (24.4)	22/89 (24.7)	adjOR 0.83 (0.22, 3.08)	NR
	NRCS	High	Minor complications	10 mo – 5 y	10/41 (24.4)	20/89 (22.5)	adjOR 0.83 (0.21, 3.29)	NR
Weichman, 2012, 22544088, US	NRCS	Moderate	Complications including mastectomy skin flap necrosis, mastectomy skin flap necrosis and associated infection, infection alone, seroma, and hematoma	3 y	NR/442 breasts (NR)	NR/186 breasts (NR)	NR	<0.05
Woo, 2017, 28509694, South Korea	NRCS	High	Major complication: Complications necessitating additional surgery or intervention	NR	26/199 (13.1)	38/199 (19.1)	adjOR 1.1 (0.5, 2.4)	0.81

: Abbreviations: adj = adjusted, ADM = acellular dermal matrix, CI = confidence interval, IBR = implant-based reconstruction, mo = months, N/A = not applicable, NR = not reported, NRCS = nonrandomized comparative study, OR = odds ratio, PMID = PubMed identifier, RCT = randomized controlled trial, RoB = risk of bias, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate study are shaded blue. The colors do not add unique information.

Table E-6.1Summary Table – Key Question 6: Comparisons of flap types for AR – continuous outcomes (physical well-being)

Study, Year, PMID, Country	Design	Overall RoB	Outcome Measurement	Time Point	Flap Type	N	Mean (SD or 95% CI)	Effect Size (95% CI)	P Value
Rindom, 2019, 31515191, Denmark	RCT	Moderate	CMSS: Total score (0–100)	1 y	LD	18	68.1 (58.2, 79.9)	Ref	Ref
	RCT	Moderate	CMSS: Total score (0–100)	1 y	TAP	22	78.7 (70.9, 86.4)	adjNMD 6.2 (0.5, 12.0)	0.033
	RCT	Moderate	CMSS: Pain (0–15)	1 y	LD	18	11.6 (9.8, 13.4)	Ref	Ref
	RCT	Moderate	CMSS: Pain (0–15)	1 y	TAP	22	14.0 (12.8, 15.2)	adjNMD 1.8 (0.2, 3.4)	0.023
	RCT	Moderate	CMSS: Activity in daily life (0–20)	1 y	LD	18	17.1 (14.9, 19.2)	Ref	Ref
	RCT	Moderate	CMSS: Activity in daily life (0–20)	1 y	TAP	22	18.7 (17.3, 20.0)	adjNMD 2.6 (1.1, 4.2)	<0.0001
	RCT	Moderate	CMSS: Range of motion (0–40)	1 y	LD	18	29.6 (24.6, 34.5)	Ref	Ref
	RCT	Moderate	CMSS: Range of motion (0–40)	1 y	TAP	22	34.8 (31.0, 38.6)	adjNMD 0.9 (−1.4, 3.2)	0.45
	RCT	Moderate	CMSS: Strength (0–25)	1 y	LD	18	9.9 (7.8, 12.0)	Ref	Ref
	RCT	Moderate	CMSS: Strength (0–25)	1 y	TAP	22	11.2 (9.3, 13.1)	adjNMD 1.2 (−1.0, 3.3)	0.29
Erdmann-Sager, 2018, 29019862, US & Canada	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	1 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	1 y	Free TRAM	NR	NR	vs. DIEP: adjMD −4.16 (−8.33, 0.02)	NR
	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	1 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD −4.01 (−8.48, 0.45)	NR
	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	1 y	SIEA	NR	NR	vs. DIEP: adjMD 4.72 (−0.07, 9.52)	NR
	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	2 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	2 y	Free TRAM	NR	NR	vs. DIEP: adjMD −4.9 (−9.50, −0.31)	NR
	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	2 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD −7.22 (−12.30, −2.14)	NR
	NRCS	Moderate	BREAST-Q: Abdomen (0–100)	2 y	SIEA	NR	NR	vs. DIEP: adjMD 0.58 (−4.79, 5.95)	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	1 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	1 y	Free TRAM	NR	NR	vs. DIEP: adjMD −1.55 (−5.35, 2.24)	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	1 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 1.52 (−1.94, 4.99)	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	1 y	SIEA	NR	NR	vs. DIEP: adjMD 3.42 (−0.22, 7.05)	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	Free TRAM	NR	NR	vs. DIEP: adjMD −2.22 (−5.89, 1.45)	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD −3.92 (−7.66, −0.18)	NR
	NRCS	Moderate	BREAST-Q: Chest, upper body (0–100)	2 y	SIEA	NR	NR	vs. DIEP: adjMD 0.76 (−3.44, 4.95)	NR
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	1 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	1 y	Free TRAM	NR	NR	vs. DIEP: adjMD −0.03 (−2.36, 2.30)	NR
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	1 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 0.00 (−2.09, 2.10)	NR
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	1 y	SIEA	NR	NR	vs. DIEP: adjMD 1.26 (−0.74, 3.26)	NR
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	2 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	2 y	Free TRAM	NR	NR	vs. DIEP: adjMD 0.42 (−1.52, 2.36)	NR
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	2 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 1.48 (−0.59, 3.55)	NR
	NRCS	Moderate	PROMIS: Physical functioning (0–100)	2 y	SIEA	NR	NR	vs. DIEP: adjMD 1.20 (−1.09, 3.49)	NR
	NRCS	Moderate	PROMIS: Pain interference (0−100)	1 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	PROMIS: Pain interference (0−100)	1 y	Free TRAM	NR	NR	vs. DIEP: adjMD 0.34 (−1.91, 2.60)	NR
	NRCS	Moderate	PROMIS: Pain interference (0−100)	1 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD −0.07 (−2.10, 1.97)	NR
	NRCS	Moderate	PROMIS: Pain interference (0−100)	1 y	SIEA	NR	NR	vs. DIEP: adjMD −0.60 (−2.54, 1.34)	NR
	NRCS	Moderate	PROMIS: Pain interference (0−100)	2 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	PROMIS: Pain interference (0−100)	2 y	Free TRAM	NR	NR	vs. DIEP: adjMD −0.50 (−2.57, 1.57)	NR
	NRCS	Moderate	PROMIS: Pain interference (0−100)	2 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 0.44 (−2.25, 3.13)	NR
	NRCS	Moderate	PROMIS: Pain interference (0−100)	2 y	SIEA	NR	NR	vs. DIEP: adjMD 0.11 (−2.34, 2.57)	NR

: Abbreviations: adj = adjusted, CI = confidence interval, CMSS = Constant Murley Shoulder Score, DIEP = deep inferior epigastric perforator, LD = latissimus dorsi, MD = mean difference, NMD = net mean difference, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, PROMIS = Patient-Reported Outcomes Measurement Information System, RCT = randomized controlled trial, Ref = reference group, RoB = risk of bias, SD = standard deviation, SIEA = superficial inferior epigastric artery perforator, TRAM = transverse rectus abdominis myocutaneous, TAP = thoracodorsal artery perforator, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate study are shaded blue. The colors do not add unique information.

Table E-6.2Summary Table – Key Question 6: Comparisons of flap types for AR – NRCS, continuous outcomes (psychosocial and sexual well-being)

Study, Year, PMID, Country	Overall RoB	Outcome Measurement	Time Point	Flap Type	N	Mean (SD)	Effect Size (95% CI)	P Value
Erdmann-Sager, 2018, 29019862, US & Canada	Moderate	BREAST-Q: Psychosocial WB (0–100)	1 y	DIEP	NR	NR	Ref	Ref
	Moderate	BREAST-Q: Psychosocial WB (0–100)	1 y	Free TRAM	NR	NR	vs. DIEP: adjMD −1.14 (−5.33, 3.05)	NR
	Moderate	BREAST-Q: Psychosocial WB (0–100)	1 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 1.27 (−3.43, 5.97)	NR
	Moderate	BREAST-Q: Psychosocial WB (0–100)	1 y	SIEA	NR	NR	vs. DIEP: adjMD −0.67 (−5.66, 4.32)	NR
	Moderate	BREAST-Q: Psychosocial WB (0–100)	2 y	DIEP	NR	NR	Ref	Ref
	Moderate	BREAST-Q: Psychosocial WB (0–100)	2 y	Free TRAM	NR	NR	vs. DIEP: adjMD −0.08 (−5.33, 5.18)	NR
	Moderate	BREAST-Q: Psychosocial WB (0–100)	2 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 0.62 (−3.95, 5.20)	NR
	Moderate	BREAST-Q: Psychosocial WB (0–100)	2 y	SIEA	NR	NR	vs. DIEP: adjMD 1.64 (−3.64, 6.91)	NR
	Moderate	BREAST-Q: Sexual WB (0–100)	1 y	DIEP	NR	NR	Ref	Ref
	Moderate	BREAST-Q: Sexual WB (0–100)	1 y	Free TRAM	NR	NR	vs. DIEP: adjMD −2.33 (−7.10, 2.44)	NR
	Moderate	BREAST-Q: Sexual WB (0–100)	1 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 0.81 (−4.31, 5.93)	NR
	Moderate	BREAST-Q: Sexual WB (0–100)	1 y	SIEA	NR	NR	vs. DIEP: adjMD −2.66 (−8.63, 3.31)	NR
	Moderate	BREAST-Q: Sexual WB (0–100)	2 y	DIEP	NR	NR	Ref	Ref
	Moderate	BREAST-Q: Sexual WB (0–100)	2 y	Free TRAM	NR	NR	vs. DIEP: adjMD 2.35 (−3.40, 8.10)	NR
	Moderate	BREAST-Q: Sexual WB (0–100)	2 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD −2.61 (−8.97, 3.75)	NR
	Moderate	BREAST-Q: Sexual WB (0–100)	2 y	SIEA	NR	NR	vs. DIEP: adjMD 1.97 (−4.15, 8.09)	NR

: Abbreviations: adj = adjusted, CI = confidence interval, DIEP = deep inferior epigastric perforator, LD = latissimus dorsi, MD = mean difference, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RCT = randomized controlled trial, Ref = reference group, RoB = risk of bias, SD = standard deviation, SIEA = superficial inferior epigastric artery perforator, TRAM = transverse rectus abdominis myocutaneous, WB = well-being, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.

Table E-6.3Summary Table – Key Question 6: Comparisons of flap types for AR – continuous outcomes (patient satisfaction with breasts and duration of initial hospitalization)

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Measurement	Time Point	Flap Type	N	Mean (SD or Range)	Effect Size (95% CI)	P Value
Brandberg, 2000, 10626972, Sweden	RCT	High	Patient satisfaction with breasts	Cosmetic (1–6)	1 y	TRAM	26	5.6 (NR)	vs. LD: MD 0.36^*	NR
	RCT	High	Patient satisfaction with breasts	Cosmetic (1–6)	1 y	LD	23	5.14 (NR)	vs. LTD: MD −0.05^*	NR
	RCT	High	Patient satisfaction with breasts	Cosmetic (1–6)	1 y	LTD	12	5.19 (NR)	vs. TRAM: −0.46^*	NR
	RCT	High	Patient satisfaction with breasts	Shape (1–6)	1 y	TRAM	26	5.3 (NR)	vs. LD: MD 0.36^*	NR
	RCT	High	Patient satisfaction with breasts	Shape (1–6)	1 y	LD	23	4.94 (NR)	vs. LTD: MD 0.35^*	NR
	RCT	High	Patient satisfaction with breasts	Shape (1–6)	1 y	LTD	12	4.59 (NR)	vs. TRAM: MD −0.71^*	NR
	RCT	High	Patient satisfaction with breasts	Size (1–6)	1 y	TRAM	26	5.43 (NR)	vs. LD: MD 0.50^*	NR
	RCT	High	Patient satisfaction with breasts	Size (1–6)	1 y	LD	23	4.93 (NR)	vs. LTD: MD −0.18^*	NR
	RCT	High	Patient satisfaction with breasts	Size (1–6)	1 y	LTD	12	5.11 (NR)	vs. TRAM: MD −0.32^*	NR
	RCT	High	Patient satisfaction with breasts	Scars on the breast (1–6)	1 y	TRAM	26	4.83 (NR)	vs. LD: MD 0.36^*	NR
	RCT	High	Patient satisfaction with breasts	Scars on the breast (1–6)	1 y	LD	23	4.47 (NR)	vs. LTD: MD −0.65^*	NR
	RCT	High	Patient satisfaction with breasts	Scars on the breast (1–6)	1 y	LTD	12	5.12 (NR)	vs. TRAM: MD 0.29^*	NR
	RCT	High	Patient satisfaction with breasts	Donor site scars (1–6)	1 y	TRAM	26	4.76 (NR)	vs. LD: MD 0.07^*	NR
	RCT	High	Patient satisfaction with breasts	Donor site scars (1–6)	1 y	LD	23	4.69 (NR)	vs. LTD: MD −0.26^*	NR
	RCT	High	Patient satisfaction with breasts	Donor site scars (1–6)	1 y	LTD	12	4.95 (NR)	vs. TRAM: MD 0.19^*	NR
	RCT	High	Patient satisfaction with breasts	Similarity with contralateral breast (1–6)	1 y	TRAM	26	4.76 (NR)	vs. LD: MD 0.10^*	NR
	RCT	High	Patient satisfaction with breasts	Similarity with contralateral breast (1–6)	1 y	LD	23	4.66 (NR)	vs. LTD: MD 0.81^*	NR
	RCT	High	Patient satisfaction with breasts	Similarity with contralateral breast (1–6)	1 y	LTD	12	3.85 (NR)	vs. TRAM: MD −0.91^*	NR
Erdmann-Sager, 2018, 29019862, US & Canada	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	1 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	1 y	Free TRAM	NR	NR	vs. DIEP: adjMD 0.04 (−4.56, 4.63)	NR
	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	1 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 1.36 (−3.45, 6.17)	NR
	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	1 y	SIEA	NR	NR	vs. DIEP: adjMD −1.82 (−6.37, 2.72)	NR
	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2 y	DIEP	NR	NR	Ref	Ref
	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2 y	Free TRAM	NR	NR	vs. DIEP: adjMD −2.61 (−8.97, 3.75)	NR
	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2 y	Pedicled TRAM	NR	NR	vs. DIEP: adjMD 1.36 (−3.45, 6.17)	NR
	NRCS	Moderate	Patient satisfaction with breasts	BREAST-Q: Satisfaction with breast (0–100)	2 y	SIEA	NR	NR	vs. DIEP: adjMD 0.42 (−5.56, 6.4)	NR
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Duration of initial hospitalization	Number of days	Post-op	LD	18	6.4 d (3–12)	Ref	Ref
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Duration of initial hospitalization	Number of days	Post-op	TAP	22	6.5 d (4–14)	vs. TAP: 0.9 d ( −1.4, 3.2)	0.45
Zoghbi, 2017, 28052051, US	NRCS	High	Duration of initial hospitalization	Number of days	Post-op	DIEP	9699	4.68 d (2.80)	Ref	Ref
Zoghbi, 2017, 28052051, US	NRCS	High	Duration of initial hospitalization	Number of days	Post-op	TRAM	6137	4.79 d (2.69)	vs. DIEP: NR	<0.001

: Abbreviations: adj = adjusted, CI = confidence interval, DIEP = deep inferior epigastric perforator, LD = latissimus dorsi, LTD = lateral thoracodorsal flap, MD = mean difference, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RCT = randomized controlled trial, Ref = reference group, RoB = risk of bias, SD = standard deviation, SIEA = superficial inferior epigastric artery perforator, TRAM = transverse rectus abdominis myocutaneous, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: calculated.

Table E-6.4Summary Table – Key Question 6: Comparisons of flap types for AR – categorical outcomes (patient satisfaction with breasts, patient satisfaction with outcome, recurrence of breast cancer, and duration of initial hospitalization)

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Measurement	Time Point	Flap Type	n/N (%)	Adjusted Odds Ratio (95% CI)	P Value
Yueh, 2009, 19228537, US	NRCS	High	Patient satisfaction with breasts	Satisfied with breasts	NR	DIEP	NR/117 (NR)	vs. TRAM: 0.67 (0.37, 1.23)	NR
	NRCS	High	Patient satisfaction with breasts	Satisfied with breasts	NR	TRAM	102/143 (71.3)	Ref	Ref
	NRCS	High	Patient satisfaction with breasts	Satisfied with breasts	NR	LD	68/112 (60.7)	vs. TRAM: 0.78 (0.54, 1.14)	NR
	NRCS	High	Patient satisfaction with outcome	Generally satisfied with outcome	NR	DIEP	NR/117 (NR)	vs. TRAM: 0.82 (0.33, 2.01)	NS
	NRCS	High	Patient satisfaction with outcome	Generally satisfied with outcome	NR	TRAM	98/143 (68.5)	Ref	Ref
	NRCS	High	Patient satisfaction with outcome	Generally satisfied with outcome	NR	LD	63/112 (56.3)	vs. TRAM: 0.77 (0.53, 1.11)	NS
Brandberg, 2000, 10626972, Sweden	RCT	High	Recurrence of breast cancer	NR	1 y	TRAM	2/29 (6.9)	vs. LD: 2.15 (0.18, 25.07)^*	0.54
	RCT	High	Recurrence of breast cancer	NR	1 y	LD	1/30 (3.33)	vs. LTD: 1.07 (0.03, 33.69)^*	0.97
	RCT	High	Recurrence of breast cancer	NR	1 y	LTD	0/16 (0)	vs. TRAM: 0.44 (0.02, 10.28)^*	0.61
Zoghbi, 2017, 28052051, US	NRCS	High	Duration of initial hospitalization	Increased length of stay	Postop	DIEP	NR/9699 (NR)	Ref	Ref
Zoghbi, 2017, 28052051, US	NRCS	High	Duration of initial hospitalization	Increased length of stay	Postop	TRAM	NR/6137 (NR)	vs. DIEP: 1.59 (1.45, 1.72)	<0.001

: Abbreviations: AR = autologous reconstruction, CI = confidence interval, DIEP = deep inferior epigastric perforator, LD = latissimus dorsi, NRCS = nonrandomized comparative study, PMID = PubMed identifier, Ref = reference group, RoB = risk of bias, TRAM = transverse rectus abdominis myocutaneous.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: Calculated.

Table E-6.5Summary Table – Key Question 6: Comparisons of flap types for AR – categorical outcomes (various)

Study, Year, PMID, Country	Design	Overall RoB	Outcome	Outcome Measurement	Time Point	Flap Type	n/N (%)	Effect Size (95% CI)	P Value
Brandberg, 2000, 10626972, Sweden	RCT	High	Mortality	NR	1 y	TRAM	1/29 (3.5)	vs. LD: OR 0.50 (0.040, 5.83)^*	0.58
	RCT	High	Mortality	NR	1 y	LD	2/30 (6.7)	vs. LTD: OR 2.21 (0.09, 52.22)^*	0.62
	RCT	High	Mortality	NR	1 y	LTD	0/16 (0)	vs. TRAM: OR 0.9 (0.03, 28.48)^*	0.95
Massenburg, 2015, 26487657, US	NRCS	High	Unpanned repeat surgeries for revision	NR	1 mo	Pedicled TRAM	159/1608 (9.9)	vs. LD: adjOR 1.71 (1.25, 2.33)	NR
Massenburg, 2015, 26487657, US	NRCS	High	Unpanned repeat surgeries for revision	NR	1 mo	LD	62/1079 (5.7)	Ref	Ref
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Pain	Shoulder related pain (Yes/No)	1 y	LD	13/18 (72)	Ref	Ref
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Pain	Shoulder related pain (Yes/No)	1 y	TAP	7/22 (32)	vs. LD: adjOR 0.05 (0.005, 0.51)	0.011
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Necrosis	Major necrosis requiring removal of the implant	1 y	LD	0/18 (0)	Ref	Ref
	RCT	Moderate	Necrosis	Major necrosis requiring removal of the implant	1 y	TAP	1/22 (4.54)	vs. LD: adjOR 1.67 (0.05, 52.7)^*	0.77^*
	RCT	Moderate	Necrosis	Minor necrosis: epidermolysis or small necrosis of most distal part of flap	1 y	LD	0/18 (0)	Ref	Ref
	RCT	Moderate	Necrosis	Minor necrosis: epidermolysis or small necrosis of most distal part of flap	1 y	TAP	2/22 (13.6)	vs. LD: adjOR 5.53 (0.26, 118.3)^*	0.27^*
Abedi, 2016, 25003437, Canada	NRCS	High	Necrosis	Mastectomy flap necrosis	1.6–1.9 y	DIEP	20/83 (24.1)	vs. TRAM: NR	0.61
Abedi, 2016, 25003437, Canada	NRCS	High	Necrosis	Mastectomy flap necrosis	1.6–1.9 y	TRAM	40/312 (12.8)	Ref	Ref
Kroll, 2000, 10987463, US	NRCS	High	Necrosis	Fat necrosis	3 mo	DIEP	36/279 breasts (12.9)	vs. TRAM: adjOR 2.10 (0.87, 5.10)	0.10
Kroll, 2000, 10987463, US	NRCS	High	Necrosis	Fat necrosis	3 mo	TRAM	9/31 breasts (29)	Ref	Ref
Erdmann-Sager, 2018, 29019862, US & Canada	NRCS	Moderate	Harms to area of flap harvest	Any donor site complication	2 y	DIEP	99/355 (27.9)	Ref	Ref
	NRCS	Moderate	Harms to area of flap harvest	Any donor site complication	2 y	Free TRAM	14/92 (15.2)	vs. DIEP: adjOR 0.52 (0.27, 1.02)	0.057
	NRCS	Moderate	Harms to area of flap harvest	Any donor site complication	2 y	Pedicled TRAM	14/78 (18.0)	vs. DIEP: adjOR 0.63 (0.32, 1.24)	0.18
	NRCS	Moderate	Harms to area of flap harvest	Any donor site complication	2 y	SIEA	33/62 (53.2)	vs. DIEP: adjOR 2.73 (1.51, 4.96)	0.001
Knox, 2016, 26267400, Canada	NRCS	High	Harms to area of flap harvest	Abdominal bulge or hernia	1.7–2.3 y	DIEP	4/130 (3.10)	Ref	Ref
Knox, 2016, 26267400, Canada	NRCS	High	Harms to area of flap harvest	Abdominal bulge or hernia	1.7–2.3 y	TRAM	80/377 (21.2)	vs. DIEP: adjOR 5.2 (1.3, 20.9)	0.002
Mennie, 2015, 25839173, UK	NRCS	High	Harms to area of flap harvest	Hernia repair	3 y	DIEP	63/5144 (1.22)	Ref	Ref
	NRCS	High	Harms to area of flap harvest	Hernia repair	3 y	Free TRAM	50/1963 (2.55)	vs. DIEP: adjOR 1.81 (1.24, 2.64)	NR
	NRCS	High	Harms to area of flap harvest	Hernia repair	3 y	Pedicled TRAM	36/822 (4.38)	vs. DIEP: adjOR 2.89 (1.91, 4.37)	NR
Zhong, 2014, 24675183, Canada	NRCS	High	Harms to area of flap harvest	Abdominal bulge or hernia	NR	DIEP	15/244 (6)	Ref	Ref
Zhong, 2014, 24675183, Canada	NRCS	High	Harms to area of flap harvest	Abdominal bulge or hernia	NR	TRAM	8/48 (17)	vs. DIEP: adjOR 2.73 (1.01, 7.07)	0.04
Brorson 2020b, 32807615, Sweden	RCT	High	Thromboembolic events	DVT	1 mo	DIEP	0/24 (0)	No events	N/A
	RCT	High	Thromboembolic events	DVT	1 mo	LD	0/32 (0)	No events	N/A
	RCT	High	Thromboembolic events	PE	1 mo	DIEP	0/24 (0)	No events	N/A
	RCT	High	Thromboembolic events	PE	1 mo	LD	0/32 (0)	No events	N/A
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Infections	Any infection	1 y	LD	1/18 (5.6)	Ref	Ref
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Infections	Any infection	1 y	TAP	1/22 (4.5)	vs. LD: OR 1.24 (0.07, 21.2)^*	0.88^*
Zoghbi, 2017, 28052051, US	NRCS	High	Infections	Wound infections	Postop	TRAM	NR/6137 (NR)	vs. DIEP: adjOR 1.67 (1.23, 2.27)	0.001
Zoghbi, 2017, 28052051, US	NRCS	High	Infections	Wound infections	Postop	DIEP	NR/9699 (NR)	Ref	Ref
Zoghbi, 2017, 28052051, US	NRCS	High	Wound dehiscence	NR	NR	DIEP	NR/9699 (NR)	Ref	Ref
Zoghbi, 2017, 28052051, US	NRCS	High	Wound dehiscence	NR	NR	TRAM	NR/6137 (NR)	vs. DIEP: adjOR 4.3 (NR)	<0.00001
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Seroma	NR	1 y	LD	1/18 (5.6)	Ref	Ref
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Seroma	NR	1 y	TAP	0/22 (0)	vs. LD: OR 2.53 (0.08, 80.0)^*	0.59^*
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Hematoma	NR	1 y	LD	0/18 (0)	Ref	Ref
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Hematoma	NR	1 y	TAP	1/22 (4.5)	Not calculable (no events in Ref group)	Not calculable
Kroll, 2000, 10987463, US	NRCS	High	Flap failure/loss	Partial flap loss	3 mo	DIEP	5/31 breasts (16.1)	vs. TRAM: adjOR 6.74 (1.83, 24.7)	0.004
Kroll, 2000, 10987463, US	NRCS	High	Flap failure/loss	Partial flap loss	3 mo	TRAM	6/279 breasts (2.20)	Ref	Ref
Massenburg, 2015, 26487657, US	NRCS	High	Flap failure/loss	NR	1 mo	Pedicled TRAM	67/2464 (2.7)	vs. LD: adjOR 2.28 (1.38, 3.77)	0.001
Massenburg, 2015, 26487657, US	NRCS	High	Flap failure/loss	NR	1 mo	LD	22/2085 (1.1)	Ref	Ref

: Abbreviations: adj = adjusted AR = autologous reconstruction, CI = confidence interval, DIEP = deep inferior epigastric perforator, DVT = deep vein thrombosis, LD = latissimus dorsi, LTD = lateral thoracodorsal flap, OR = odds ratio, PE = pulmonary embolism, RCT = randomized controlled trial, PMID = PubMed identifier, Ref = reference group, RoB = risk of bias, TRAM = transverse rectus abdominis myocutaneous, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate outcome are shaded blue. The colors do not add unique information.
*: Calculated.

Table E-6.6Summary Table – Key Question 6: Comparisons of flap types for AR – categorical outcomes (composite or unspecified harms)

Study, Year, PMID, Country	Design	Overall RoB	Outcome Description	Time Point	Flap Type	n/N (%)	Comparison	Adjusted Odds Ratio (95% CI)	P Value
Brorson 2020b, 32807615, Sweden	RCT	High	Clavien-Dindo Grade I complications	1 mo	DIEP	16/34 (47)	Ref	Ref	Ref
	RCT	High	Clavien-Dindo Grade I complications	1 mo	LD	20/33 (63)	vs. DIEP	1.73 (0.66, 4.57)	0.27
	RCT	High	Clavien-Dindo Grade II complications	1 mo	DIEP	14/34 (41)	Ref	Ref	Ref
	RCT	High	Clavien-Dindo Grade II complications	1 mo	LD	16/32 (50)	vs. DIEP	1.29 (0.48, 3.44)	0.76
	RCT	High	Clavien-Dindo Grade IIIa complications	1 mo	DIEP	9/34 (26)	Ref	Ref	Ref
	RCT	High	Clavien-Dindo Grade IIIa complications	1 mo	LD	7/32 (22)	vs. DIEP	0.85 (0.27, 2.64)	0.77
	RCT	High	Clavien-Dindo Grade IIIb complications	1 mo	DIEP	11/34 (32)	Ref	Ref	Ref
	RCT	High	Clavien-Dindo Grade IIIb complications	1 mo	LD	3/32 (9)	vs. DIEP	0.22 (0.05, 0.87)	0.031
	RCT	High	Clavien-Dindo Grade IV complications	1 mo	DIEP	0/34 (0)	Ref	No events	N/A
	RCT	High	Clavien-Dindo Grade IV complications	1 mo	LD	0/32 (0)	vs. DIEP	No events	N/A
	RCT	High	Clavien-Dindo Grade V complications	1 mo	DIEP	0/34 (0)	Ref	No events	N/A
	RCT	High	Clavien-Dindo Grade V complications	1 mo	LD	0/32 (0)	vs. DIEP	No events	N/A
Rindom, 2019, 31515191, Denmark	RCT	Moderate	Minor complications treated conservatively	1 y	LD	2/18 (11.1)	Ref	Ref	Ref
	RCT	Moderate	Minor complications treated conservatively	1 y	TAP	2/22 (9.09)	vs. LD	0.8 (0.1, 6.32)^*	0.83^*
	RCT	Moderate	Major complications requiring surgical intervention	1 y	LD	0/18 (0)	Ref	Ref	Ref
	RCT	Moderate	Major complications requiring surgical intervention	1 y	TAP	4/22 (18)	vs. LD	0.13 (0.01, 2.62)^*	0.18^*
Dauplat, 2021, 33622886, France	NRCS	Moderate	Major complications requiring surgical intervention or readmission	1 y	TRAM	10/30 (30)	Ref	Ref	Ref
	NRCS	Moderate	Major complications requiring surgical intervention or readmission	1 y	LD with implant	9/91 (9)	Ref	Ref	Ref
	NRCS	Moderate	Major complications requiring surgical intervention or readmission	1 y	LD without implant	7/78 (9)	vs. TRAM vs. LD with implant	1.69 (1.19, 2.41) 4.85 (1.67, 14.1)	NR NR
Erdmann-Sager, 2018, 29019862, US & Canada	NRCS	Moderate	Any breast complication	2 y	DIEP	NR	Ref	Ref	Ref
	NRCS	Moderate	Any breast complication	2 y	Free TRAM	NR	vs. DIEP	0.51 (0.25, 1.02)	0.58
	NRCS	Moderate	Any breast complication	2 y	Pedicled TRAM	NR	vs. DIEP	0.94 (0.46, 1.94)	0.87
	NRCS	Moderate	Any breast complication	2 y	SIEA	NR	vs. DIEP	1.15 (0.61, 2.17)	0.67
Massenburg, 2015, 26487657, US	NRCS	High	Any complication	1 mo	Pedicled TRAM	216/1608 (13.4)	vs. LD	1.92 (1.45, 2.55)	NR
	NRCS	High	Any complication	1 mo	LD	77/1079 (7.1)	Ref	Ref	Ref
	NRCS	High	Superficial SSI, deep SSI, organ space infection, or wound disruption/dehiscence	1 mo	Pedicled TRAM	199/2464 (8.1)	vs. LD	1.80 (1.29, 2.51)	0.001
	NRCS	High	Superficial SSI, deep SSI, organ space infection, or wound disruption/dehiscence	1 mo	LD	90/2085 (4.3)	Ref	Ref	Ref
Zhong, 2014, 24675183, Canada	NRCS	High	Major breast complications (total/partial flap loss, fat necrosis, or breast hematoma)	NR	DIEP	50/244 (20.5)	Ref	Ref	Ref
Zhong, 2014, 24675183, Canada	NRCS	High	Major breast complications (total/partial flap loss, fat necrosis, or breast hematoma)	NR	TRAM	10/48 (20.8)	vs. DIEP	0.98 (0.4, 2.14)	0.95

: Abbreviations: AR = autologous reconstruction, CI = confidence interval, DIEP = deep inferior epigastric perforator, LD = latissimus dorsi, NR = not reported, NRCS = nonrandomized comparative study, PMID = PubMed identifier, RoB = risk of bias, TRAM = transverse rectus abdominis myocutaneous, SIEA = superficial inferior epigastric artery, SSI = surgical site infection, TAP = thoracodorsal artery perforator, y = years.
: Colors: Header rows are shaded orange. Rows for every alternate study are shaded blue. The colors do not add unique information.
*: Calculated.

Bookshelf ID: NBK572810

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