LINX® reflux management system to bridge the “treatment gap” in gastroesophageal reflux disease: A systematic review of 35 studies

Table 1 Demographic and clinical characteristics of magnetic sphincter augmentation studies with typical inclusion criteria

Ref.	Study period	Procedure	Follow-up (mo)	Study type	No. of patients (follow-up)	Mean age (yr)	Mean BMI (kg/m2)	Mean OR time (min)	DeMeester score		PPI-free	Dilationdue todysphagia	Dysphagia(%, post-op)	GERD-HRQL score (mean)		Removal in MSA or re-operation in LF
									Baseline	Post-op				Baseline	Post-op
Bonavina et al[11], 2008; Bonavina et al[20], 2010; Lipham et al[21], 2012; Saino et al[22], 2015												Patient groups part of Bonavina et al[13], 2013
Ganz et al[23], 2013												Same patient group with Ganz et al[23], 2013
Bonavina et al[24], 2013	2007-2012	MSA	12-72	SA	100 (95)	44.5	24	47	42.3	11.2	85%	2	NA	16-24	2	3
Smith et al[25], 2014	2011-2013	MSA	1-18.6	SA	66 (66)	53.7	26	NA	NA		83%	4	NA	26	6	0
Ganz et al[26], 2016	2009-2014	MSA	60	SA	100 (85)	53	28	NA	NA		75%	NA	6%	11-27	4	7
Warren et al[17], 2016	2009- 2015	MSA	19-60	SA	170 (170)	53	27	51	37.9	15.6	79%	NA	NA	26	5	1
Czosnyka et al[27], 2016	NA	MSA	7.6	SA	102 (102)	54	28	NA	NA		92%	9	9%	27	5	1
Prakash et al[28], 2017	2012-2015	MSA	12-36	SA	47 (47)	53.6	NA	73	NA		83.3%	2	NA	25.8	5.2	0
Schwameis et al[29], 2018	2012-2017	MSA	13	SA	68 (68)	45	25	27	NA		87%	2	16-21%	24	3	2
Louie et al[30], 2019	2013-2015	MSA	12	SA	200 (182)	48.5	27.4	NA	33.4	12.0	87.4%	13	36.6%	26	4	5
Louie et al[31], 2014	2012-2013	MSA	6	Comp.	34 (24)	54	27	73	49.5	14.2	100%	1	NA	20.6	5.0	0
		LF	10		32 (32)	47	30	118	49	5.1	97%	0		22.8	5.1	2
Sheu et al[32], 2014	2012-2013	MSA	7	Comp.	12 (12)	39.3	26.8	63.7	NA		NA	4	83%	NA	NA	NA
		LF	7		12 (12)	43.8	26.8	90.3				0	58%
Reynolds et al[33], 2015	2010-2013	MSA	12	Comp.	50 (47)	53	26.4	N.A	NA		83%	8	36.2%	19.7	4.2	0
		LF	12		50 (47)	54	26.7				91.5%	5	31.9%	18.8	4.3	2
Riegler et al[16], 2015	2010- 2013	MSA	12	Comp.	202 (202)	46.6	25.7	NA	NA		81.8%	NA	NA	20	3	8
		LF	12		47 (47)	52.8	26.1				63%			23	3	3
Warren et al[34], 2015	2007-2014	MSA	> 12	Comp.	201 (169)	54	NA	60	NA		76%	NA	44%	21	3	2
		LF	> 12		214 (185)	52		76			88%		32%	19	4	2
Reynolds et al[35], 2016	2010-2013	MSA	12	Comp.	52 (48)	53	26	66	NA		85%	9	46%	17	4	0
		LF	12		67 (59)	53	27	82			92%	8	56%	19	5	2
Asti et al[36], 2016	2007-2014	MSA	12-80	Comp.	135(135)	44	23.94	42	NA		NA	NA	NA	21	0-3	NA
		LF	12-80		103(103)	50	25.1	87						15	2-4
MSA total		20 MSA	6-80	13 SA	1539 (1452)	39.3-54	23.94-28	27-73	33.4-49.5	11.2-15.6	75%-100%	8% (54/713)	6%-83%	11-27	0-6	2% (29/1305)
NISSEN total		7 LF	7-80	7 Comp.	525 (485)	43.8-54	25.1-30	76-118	49	5.1	63%-97%	9% (13/150)	31.9%-58%	15-23	2-5.1	3% (11/370)

NA: Not available; LF: Laparoscopic fundoplication (Nissen or Toupet); MSA: Magnetic sphincter augmentation; SA: Single-armed; Comp.: Comparative.

Table 2 Demographic and clinical characteristics of bariatric patients with magnetic sphincter augmentation devices

Ref.	Study period	No. of patients (follow-up)	Type of surgery	BMI on bariatric surgery (kg/m2, mean)	BMI loss between bariatric surgery and MSA (kg/m2, range)	BMI on MSA implan-tation (kg/m2, mean)	Mean period between surgery and MSA (mo)	Pre-operativeGERD-HRQL score	Post-operativeGERD-HRQL score	Compli-cations/ satis-faction
Desart et al[44], 2015	2014-2015	7 (7)	7 LSG	50.7	9.4-25.5	NA	18.1	17-18	5-6	NA/All patients satisfied
Hawasli et al[45], 2018	2015-2017	13 (13)	13 LSG	46	NA	33 (21-44 range)	43	47 (mean)	12 (mean)	1 Severe dysphagia-device removal/NA
Broderick et al[46], 2019	2014-2018	13 (6 with GERD-HRQL score)	8 LSG 4 LRYGB 1 DS	NA	NA	30.1	NA	15-45	5-13	2 endoscopic dilations/All patients satisfied
Cumu-lative Data	2014-2018	33 (26)	34 LSG 4 LRYGB 1 DS	Not enough information to compile cumulative data

LSG: Laparoscopic sleeve gastrectomy; LRYGB: Laparoscopic Roux-en-Y gastric bypass; DS: Duodenal switch; MSA: Magnetic sphincter augmentation; N.A.: Not available.