The Choice of Primary Repair or Mesh Repair for Paraesophageal Hernia

A Decision Analysis Based on Utility Scores

Nadia M. Obeid, MD; Vic Velanovich, MD

Annals of Surgery. 2013;257(4):655-664.

Abstract and Introduction

Abstract

Background: Controversy exists on the use of mesh in the repair of paraesophageal hernias (PEH). This debate centers around the type of mesh used, its value in preventing recurrence, its short- and long-term complications, and the consequences of those complications compared with primary repair. Decision analysis is a method to account for the important aspects of a clinical decision. The purpose of this study was to determine whether or not the addition of mesh would be superior in PEH repair.

Methods: A decision analysis model of the choice between primary repair and mesh repair of a PEH was constructed. The essential features of the decision were the rate of perioperative complications, PEH recurrence rate, reoperation rate after recurrence, rate of symptomatic recurrence, and type of outcome after reoperation. The literature was reviewed to obtain data for the decision analysis and the average rates used in the baseline analysis. A utility score was used as the outcome measure, with a perfect outcome receiving a score of 100 and death 0. Sensitivity analysis was used to determine if changing the rates of recurrence or reoperation changed the dominant treatment.

Results: Using the baseline analysis, mesh repair was slightly superior to primary repair (utility score 99.59 vs 99.12, respectively). However, if recurrence rates were similar, primary repair would be slightly superior; whereas if reoperation rates were similar, mesh repair would be superior. Using sensitivity analysis, there are combinations of recurrence rates and reoperation rates that would make one repair superior to the other. However, these differences are relatively small.

Conclusions: Depending on what the decision-maker accepts as the recurrence and reoperation rates for these types of repair, either mesh or primary repair may be the treatment of choice. However, the differences between the two are small, and, perhaps, clinically inconsequential.

Introduction

In the early 1990s, the first laparoscopic paraesophageal hernia (PEH) repairs were performed, and over the subsequent years, this approach has become the standard,^[1] with good improvement in quality of life.^[2] Since then, controversies have developed pertaining to whether observation or operation is the best approach for asymptomatic PEHs,^[3] the frequency of and the need to intervene for the "short esophagus,"^[4] whether open laparotomy/thoracotomy or laparoscopic operations provide a more durable repair,^[5] the need for gastropexy or fundoplication,^[6] and, last, whether the hiatal defect requires mesh or not for repair, and if so, what type of mesh.^[7]

The use of mesh to repair PEH started in the open surgery era, but has grown increasingly popular as laparoscopic repair has become the standard. The rationale behind a mesh repair is that it would provide a "tension-free" repair analogous to mesh repair of inguinal or incisional hernias.^[8–11] However, mesh PEH repairs have not become standardized, with variation in the type of mesh (broadly categorized into prosthetic or biological material), shape of mesh (strip, U-shape, or key-hole patterns), and fixation methods (suture or tacking device).^[12] Reports then began to be published pertaining to mesh-related complications, the most serious of which were erosions of the mesh into the esophagus.^[13–16] This lead to the popularization of biological mesh materials, with the rationale being that these would cause fewer mesh-related complications.^[17] After initial enthusiasm, some have questioned the value of mesh PEH repairs.

Decision analysis is a method to explicitly account for all, or at least the most important, aspects of a decision to determine the most optimal choice.^[18] This method requires identification of the possible consequences of the decision, the likelihood of these consequences occurring, and the impact of their occurrence. We hypothesized that this method would determine clear superiority of mesh repair or primary repair of PEHs.

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Abstract and Introduction
Methods
Results
Discussion
References

Table 1. Definition of Terms Used in the Decision Analysis
Term	Definition
Paraesophageal hernia	Types II, III, and IV
Primary repair	All types of suture repair of the diaphragmatic hiatus without any nonautologous materials with or without fundoplication
Mesh repair	All types of repair of the diaphragmatic hiatus with any nonautologous material (biological or prosthetic) with or without fundoplication
Recurrence	Any documented re-herniation, either clinical or radiological
No recurrence	No documented re-herniation reported (this implies a good outcome)
Symptomatic recurrence	Recurrence with symptoms attributable to the recurrent paraesophageal hernia
Asymptomatic recurrence	Recurrence of paraesophageal hernia without reported symptoms attributable to the hernia
Reoperation	An operation required to address anatomical or symptomatic recurrence or other problems related to the index paraesophageal hernia repair
Good outcome	Outcome of reoperation for recurrent paraesophageal hernia in which the recurrent hernia was repaired with no need for esophageal or gastric resection
Severe adverse outcome	Outcome of initial operation or reoperation for recurrent paraesophageal hernia that resulted in esophageal erosions, stricture, or esophageal or gastric resection
Perioperative complications	Short-term postoperative complications requiring intervention (ie, Clavien class III or IV complications)
Death	Death directly related to the paraesophageal hernia repair

Table 2. Sources of Data for Initial Operative Outcomes
Reference	Location	Study Type	Operation	Hiatal Repair	Follow-Up*	Adverse Events†	Death	Recurrence‡
Gangopadhyay et al²³	USA	Retrospective	Nissen, Gastropexy, Collis	Primary N = 15; biologic mesh N = 29	25 months	‡
Granderath et al¹⁹	Europe, USA	Literature review of 42 studies on prosthetic mesh repair	Multiple types	Primary N = 1141; mesh N = 985 (polyester, polypropylene, PTFE)	8–76 months	Primary, not reported; Mesh 6.9%	Not reported	Primary 10% (0–26%); mesh 1.6% (0–33%)
Johnson et al²⁰	USA	Literature review of 19 studies on mesh repair	Not reported	Primary N = 639; mesh N = 729 (polypropylene)	Primary, 20.7 months; mesh, 19.2 months	Not reported	Not reported	Primary 13%; mesh 2.8%
Mehta et al²¹	England	Literature review of 20 studies	Multiple types	Primary N = 1285; mesh N = 130	12–46 months	7%‡	1.1%‡	27%‡
Muller-Stich et al²⁴	Switzerland	Retrospective	Dor, Toupet, Nissen	Primary N = 40; mesh N = 16 (polypropylene, Vicryl)	Primary 67 months (9–117); mesh 20 months (10–60)§	Not reported	0% both groups	Primary 11%; mesh 0%
Oelschalger et al²⁵	USA	Prospective, randomized trial	Nissen, Collis	Primary N = 57; biologic mesh N = 51	6 months	Primary 0%; mesh 2%	Primary 3.5%; mesh 0%	Primary 24%; mesh 9%
Parameswaran et al²⁶	England	Retrospective	Nissen, Gastropexy	Primary N = 32; mesh N = 17 (composite, PTFE, biologic)	19 months	2%‡	0%	Primary 9.4%; mesh 5.9%
Whitson et al²⁷	USA	Retrospective	Collis	Primary N = 61	3 years	1.6%	1.6%	4.7%
Wisbach et al²⁸	USA	Retrospective	Nissen	Biologic mesh N = 11	1 year	0%	0%	9%
Lubezky et al²⁹	Israel	Retrospective	Nissen	Prosthetic mesh N = 44	28 months	10%	0%	13%
Rathore et al²²	Northern Ireland	Meta-analysis of 13 studies	Not reported	Not reported N = 965	>6 months	Not reported	Not reported	12.2%
Zaninotto et al³⁰	Italy	Retrospective	Nissen, Toupet	Primary N = 19; mesh N = 35 (Dual-Mesh)	71 months	7%‡	0%‡	Primary 42%; mesh 8.6%
Boushey et al³¹	Canada	Retrospective	Nissen Gastropexy	Primary N = 56; mesh N = 2	6 months	3%‡	0%	9%
Hazebroek et al³²	Australia	Prospective	Nissen-Rosetti	Mesh N = 19 (Dual-Mesh)	2 years	5.2%	0%	5.2%
Karmali et al³³	Canada	Retrospective	Nissen, Toupet, Collis	Primary N = 93	17 months	13–21%	0%	9%
Lee et al³⁴	USA	Retrospective	Nissen	Biologic mesh N = 52	16 months	5.5%	0%	3.8%
White et al³⁵	USA	Retrospective	Nissen, Toupet, Dor, Collis, Gastropexy	Primary N = 31	11.3 years	Not reported	Not reported	14%
Zugel et al³⁶	Luxembourg	Retrospective	Nissen	Primary N = 17; mesh N = 9 (composite)	24 months	Primary 6% Mesh 11%	0%	Primary 30%; mesh 0%
Luketich et al³⁷	USA	Retrospective	Nissen, Collis	Primary N = 574; mesh N = 88	1–12 years	18.6%‡	1.7%‡	Primary 15%; mesh 21%
Poncet et al³⁸	France	Retrospective	Nissen-Rosetti, Gastropexy	Primary N = 89	57.5 months	1.1%	0%	15.7%
Dallemagne et al³⁹	Belgium	Retrospective	Nissen	Primary N = 78; mesh N = 7	151 months	Primary 1%	0%	66%‡
Gouvas et al⁴⁰	Greece	Retrospective	Nissen	Primary N = 48; mesh N = 20 (PTFE)	12 months	0%	0%	Not reported
Mittal et al⁴¹	USA	Retrospective	Multiple fundoplications, Collis, Gastropexy	Primary N = 63; mesh N = 10	5 years	19.2%‡	1.4%‡	Primary 4.8%; mesh 10%
Oelschlager et al⁴²	USA	Randomized clinical trial	Nissen, Collis	Primary N = 39; mesh align="center" N = 33	58 months	N/A	N/A	Primary 59%; mesh 54%
Okrainec et al⁴³	Canada	Prospective	Nissen	Primary N = 46	Not reported	Not reported	Not reported	21%
Tsang et al⁴⁴	USA	Retrospective	Nissen, Toupet, Dor, Collis	Primary N = 77; mesh N = 87 (biologic)	12 months	Not reported	0%	Not reported
Zehetner et al⁴⁵	USA	Retrospective	Nissen	Primary N = 62; mesh N = 84	12–16 months	Not reported	Not reported

*Median follow-up, or ranges.
†Clavien class III and IV complications.
‡Did not differentiate between mesh and primary repair patients in reporting adverse events, deaths, and recurrences.
§When parentheses are used, ranges of outcomes are reported.

Table 3. Data Sources of Long-Term Outcomes
Reference	Location	Study Type	Symptomatic Recurrence Rate*	Re-Operation Rate†	Esophageal or Gastric Resection Rate‡	Other Major Long-Term Adverse Events
Parameswaran et al²⁶	England	Retrospective	Primary 67%; mesh 0%	Not reported	Not reported	N/A
Metha et al²¹	England	Literature review	Not reported	4.6%§	Not reported	Not reported
Whitson et al²⁷	USA	Retrospective	Primary 0%	Not reported	Not reported	N/A
Wisbach et al²⁸	USA	Retrospective	Biologic mesh 0%	0%	N/A	N/A
Lubezky et al²⁹	Israel	Retrospective	Prosthetic mesh 71%	71%	0%	6%
Zaninotto et al³⁰	Italy	Retrospective	Not reported	Primary and mesh 45%§	Primary and mesh 33%§	N/A
Boushey et al³¹	Canada	Retrospective	Not reported	Primary 22%	Not reported	N/A
Karmali et al³³	Canada	Retrospective	Primary 100%	37.5%	Not reported	Not reported
Lee et al³⁴	USA	Retrospective	Biologic mesh 50%	50%	0%	0%
White et al³⁵	USA	Retrospective	Primary 14%	Primary 50%	Primary 0%	N/A
Soricelli et al⁴⁶	Italy	Retrospective	Mesh (polypropylene), N = 204	N/A	N/A	0.5% erosion rate at 95 months follow-up
Stadlhuber et al⁴⁷	USA	Retrospective review of reoperations; mesh (various), N = 26	N/A	N/A	34%	N/A
Zugel et al³⁶	Luxembourg	Retrospective	Primary 0%; mesh 0%	Primary 0%; mesh 11% (mesh erosion into the aorta)	Primary 0%; mesh 0%	N/A
Frantzides et al⁴⁸	USA	Survey of SAGES¶ members; mesh repair (various)	Not reported	Not reported	Not reported	0–0.5% erosion rate 0.1–0.3% stricture rate
Luketich et al³⁷	USA	Retrospective	30%§	Primary 22.4%; mesh 75%	Not reported	Not reported
Parker et al⁴⁹	USA	Retrospective review of reoperations; primary and mesh (various)	Not reported	Not reported	Primary 4.4%; mesh 30%	N/A
Poncet et al³⁸	France	Retrospective	Primary 15.7%	Primary 57%	Not reported	N/A
Mittal et al⁴¹	USA	Retrospective	25%§	25%§	0%	0%
Oelschalger et al⁴²	USA	Randomized controlled trial	Not reported	Primary 10% Mesh 0%	Primary 0%	N/A
Tsang et al⁴⁴	USA	Retrospective review of reoperations	Not reported	N/A	Primary 0% Mesh 0%	N/A
Zehetner et al⁴⁵	USA	Retrospective	Not reported	Primary and Mesh, 18.5%§	Not reported	N/A

*Symptomatic recurrence rate = no. of symptomatic PEH recurrences/total no. of PEH recurrences.
†Reoperation rate = no. of reoperations for recurrent PEH/total no. of PEH recurrences.
‡Esophageal or gastric resection rate = no. of of reoperations for recurrent PEH resulting in esophageal or gastric resection/total no. of of reoperations for recurrent PEH.
§This study did not differentiate between repair type in reporting reoperations or resections.
¶SAGES indicates Society of American Gastrointestinal and Endoscopic Surgeons.

Table 4. Sensitivity Analysis of Primary Repair With Simultaneous Variation of Recurrence Rates and Reoperation Rates
Reoperation Rate	Recurrence Rate
Reoperation Rate		0%	10%	20%	30%	50%
	0%	100%	99.85%	99.70%	99.55%	99.25%
	10%	100%	99.80%	99.60%	99.40%	99.00%
	20%	100%	99.75%	99.50%	99.25%	98.75%
	30%	100%	99.70%	99.40%	99.10%	98.50%
	50%	100%	99.60%	99.20%	98.95%	98.00%

Table 5. Sensitivity Analysis of Mesh Repair With Simultaneous Variation of Recurrence Rates and Reoperation Rates
Reoperation Rate	Recurrence Rate
Reoperation Rate		0%	10%	20%	30%	50%
	0%	100%	99.85%	99.70%	99.55%	99.25%
	10%	100%	99.76%	99.52%	99.28%	98.80%
	20%	100%	99.71%	99.34%	99.01%	98.36%
	30%	100%	99.66%	99.16%	98.74%	97.91%
	50%	100%	99.61%	98.98%	98.47%	97.47%