Surg Endosc DOI 10.1007/s00464-014-3798-x

and Other Interventional Techniques

The utilization of laparoscopy in ventral hernia repair: an update of outcomes analysis using ACS-NSQIP data Chetan V. Aher • John C. Kubasiak • Shaun C. Daly • Imke Janssen • Daniel J. Deziel • Keith W. Millikan • Jonathan A. Myers • Minh B. Luu

Received: 5 April 2014 / Accepted: 3 August 2014 Ó Springer Science+Business Media New York 2014

Abstract Background Numerous prospective studies and randomized controlled trials have demonstrated shorter length of stay, lower morbidity rates, and similar recurrence rates with laparoscopic ventral hernia repair (VHR) when compared to open VHR. Despite these promising results, previous data showed low utilization of laparoscopic VHR. The aim of our study was to evaluate the utilization of laparoscopic VHR using the most updated information from the American College of Surgeons—National Surgical Quality Improvement Project (NSQIP) dataset. The secondary aim was to evaluate the outcomes from NSQIP for patients undergoing open versus laparoscopic VHR for the outcome of 30-day mortality and the peri-operative morbidities listed in the NSQIP dataset. Methods We performed this study using 2009–2012 data from the ACS-NSQIP database. The study population included patients who had undergone an open or laparoscopic ventral hernia repair as their primary procedure based on CPT codes. Demographic characteristics, overall Presented at the SAGES 2014 Annual Meeting, April 2–5, 2014, Salt Lake City, Utah C. V. Aher (&)  J. C. Kubasiak  S. C. Daly  D. J. Deziel  K. W. Millikan  J. A. Myers  M. B. Luu Department of General Surgery, Professional Building, Suite 810, Rush University Medical Center, 1725 West Harrison Street, Chicago, IL 60612, USA e-mail: [email protected] M. B. Luu e-mail: [email protected] I. Janssen Department of Preventative Medicine, Triangle Office Building, Suite 470, Rush Graduate College, 1700 W. Van Buren Street, Chicago, IL 60612, USA

morbidity, and complications were compared using Chi-square tests for categorical variables and two-sided t tests for continuous variables. Secondary outcomes (mortality and any complications) were further analyzed using logistic regression. Results Utilization of laparoscopic VHR was 22 %. While adjusted mortality was similar, overall morbidity was increased in the open VHR group (OR 1.63; CI 95 % 1.38–1.92). The open group had a higher rate of return to the OR, pneumonia, re-intubation, ventilator requirement, renal failure/insufficiency, transfusion, DVT, sepsis, and superficial and deep incisional wound infections. Conclusions The utilization of laparoscopic VHR remained low from 2009 to 2012 and continued to lag behind the use of laparoscopy in other complex surgical procedures. The mortality rate between laparoscopic and open VHR was similar, but laparoscopic repair was associated with lower overall complication rates. Keywords Ventral hernia repair  Laparoscopic surgery  NSQIP  Mesh hernia repair More than 100,000 ventral hernia repairs (VHR) are performed in the United States each year, resulting in significant economic effects in the form of healthcare cost and lost productivity. Laparoscopic VHR was first described by LeBlanc et al. in 1993 with the goal of shortening recovery time and improving outcomes [1]. Early case series reported shorter length of stay (LOS) than open techniques, low conversion rates, and low recurrence rates [2, 3]. More recently, numerous prospective studies and randomized controlled trials have demonstrated shorter LOS, lower morbidity rates, and similar recurrence rates with laparoscopic VHR when compared to open VHR [4–11]. Pooled

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case series data demonstrated fewer wound infections and lower recurrence in laparoscopic VHR [12], and in 2008, a review by Misiakos et al. reported advantages of laparoscopic VHR including less post-operative pain, shorter recovery period, and better cosmetic results [13]. Two 2009 metaanalyses of the available randomized controlled trials showed that laparoscopic VHR decreased LOS and wound infection rate [14, 15]. Despite these promising results, a Cochrane review showed no difference in complication or recurrence rates between the two techniques [16]. Nationwide data from the American College of Surgeons—National Surgical Quality Improvement Project (ACS-NSQIP) database from 2005 to 2006 were first published by Hwang et al. [17], and then subsequently Mason et al. reported 2005–2009 data. With a larger dataset than any previous study, Mason et al. noted a significant decrease in overall morbidity with laparoscopic VHR. Also noted was a significant decrease in surgical site infections (superficial, deep, and organ/space), pulmonary embolism, and the development of sepsis in both their aggregate dataset and matched cohort. The data showed a 17 % utilization rate of laparoscopic VHR [18]. The aim of our study was to evaluate the utilization of laparoscopic VHR using the most updated information from the NSQIP dataset. The secondary aim was to evaluate the outcomes from NSQIP for patients undergoing open versus laparoscopic VHR for the outcome of 30-day mortality and the peri-operative morbidities were listed in the NSQIP dataset.

CPT codes including 49652, 49653, 49654, 49655, 49656, and 49657. The laparoscopic VHR group consisted of patients with CPT codes including 49560, 49561, 49565, 49570, 49572, 49585, 49587, and 49590. Outcomes The primary outcome was laparoscopic VHR utilization. Secondary outcomes included 30-day mortality and morbidity, which was defined as one of the following ACSNSQIP complications: respiratory (pneumonia, unplanned intubation, pulmonary embolism, or ventilator for [48 h), urinary tract (acute renal failure and progressive renal insufficiency), central nervous system (cerebral vascular accident, coma[24 h, and peripheral nerve injury), cardiac (cardiac arrest requiring CPR and myocardial infarction) and others (transfusion intraoperative/or with in 72 h, vein thrombosis, sepsis, and septic shock). Statistical analyses Demographic characteristics, overall morbidity, and complications were compared using Chi-square tests for categorical variables and two-sided t-tests for continuous variables. Secondary outcomes (mortality and any complications) were Table 1 CPT codes utilized by type of approach Laparoscopic repairs

N

49652

Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia; reducible

9,134

49653

Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia; incarcerated or strangulated

4,195

Data acquisition

49654

Laparoscopy, surgical, repair, incisional hernia; reducible

7,149

The ACS-NSQIP is a national, validated program for measuring risk-adjusted surgical outcomes with the goal of improving the quality of surgical care. The NSQIP database is populated with the information about patient demographics, pre-operative risk factors, pre-operative laboratory values, operative information, and peri-operative and post-operative 30-day outcomes. The ACS-NSQIP program then uses a systematic sampling strategy to create a mixture of patients [19–21]. We performed this study using 2009–2012 data from the ACS-NSQIP database. The study population included patients who had undergone an open or laparoscopic ventral hernia repair as their primary procedure based on CPT codes. Patients with the following CPT codes were included: 49652, 49653, 49654, 49655, 49656, 49657, 49560, 49561, 49565, 49570, 49572, 49585, 49587, and 49590 (Table 1). Emergent cases were excluded. We derived two treatment groups from the above patient selection. The open VHR group consisted of patients with

49655

Laparoscopy, surgical, repair, incisional hernia; incarcerated or strangulated

2,738

49556

Laparoscopy, surgical, repair, recurrent incisional hernia; reducible

2,029

49657

Laparoscopy, surgical, repair, recurrent incisional hernia; incarcerated or strangulated

1,041

Methods

123

Open repairs 49560

Repair initial incisional or ventral hernia; reducible

41,422

49561

Repair initial incisional or ventral hernia; incarcerated or strangulated

15,525

49565

Repair recurrent incisional or ventral hernia; reducible

11,987

49570

Repair epigastric hernia, reducible

3,175

49572

Repair epigastric hernia, incarcerated or strangulated

1,776

49585

Repair umbilical hernia, reducible [5 yrs.

36,528

49587

Repair umbilical hernia, incarcerated or strangulated [5 yrs. Repair spigelian hernia

16,111

49590

879

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further analyzed using logistic regression. We report odds ratio (OR) with 95 % confidence intervals for unadjusted analyses as well as those adjusted for covariates. Covariates included were those significantly related to outcome at level 0.05 in univariate analyses. Backward and forward selection algorithms included the same variables in all cases. The significance was set at p \ 0.05. All calculations were performed using SAS version 9.2 software (SAS Institute Inc, Cary, NC).

Results Of the patients queried from the dataset, only those with complete records were used for analysis. Between 2009 and 2012, 117,007 patients were identified using NSQIP; 90,721 (77.5 %) patients underwent open VHR and the remaining 26,286 (22.5 %) underwent laparoscopic VHR. Pre-operative characteristics are shown in Table 2. Open cases had more overall pre-operative medical conditions, were more likely to be male, have a history of congestive heart failure, ascites, esophageal varices, and be on dialysis. Laparoscopic cases were more likely to have shortness of breath and hypertension. Table 3 shows pre-operative continuous variables. Open surgery was more likely to be performed on younger patients with a lower BMI. In unadjusted analysis, 30-day mortality was higher in the open VHR group with an odds ratio (OR) of 1.59 (CI 95 % 1.21–2.09); however, mortality did not remain statistically significant in the adjusted model (OR 0.67; CI 95 % 0.39–1.15). The open group had a higher rate of return to the OR, pneumonia, re-intubation, ventilator requirement, renal failure/insufficiency, transfusion, DVT, sepsis, and superficial and deep incisional wound infections (Table 4). In the adjusted model (Table 5), increased overall morbidity in the open VHR group remained statistically significant (OR 1.63; CI 95 % 1.38–1.92). Preoperative patient characteristics that carried an increased rate of morbidity in the adjusted model included current pneumonia (OR 2.48; CI 95 % 1.28–4.81), wound infection (OR 2.69; CI 95 % 2.11–3.43), and transfusion (OR 3.08; CI 95 % 1.62–5.83), as shown in Table 5.

Discussion Ventral hernia remains a common problem encountered in surgical practice. The early reports of laparoscopic repair showed the technique to be safe with similarity in recurrence to open techniques. As methods improved, numerous case series, randomized controlled trials, and meta-analyses began to demonstrate shorter hospital stays, fewer wound infections, better quality of life scores, and longterm durability of laparoscopic repair compared with open

approaches. The first NSQIP data published showed fewer total and infectious complications in the laparoscopic group compared with open repair [17]. Subsequent analyses using 2005–2009 data from NSQIP again demonstrated benefits of laparoscopic repair with a low utilization rate of 17 % [18]. In the current study, we found a utilization rate of laparoscopic VHR of 22 %, up only slightly from the previously reported 17 %. The 30-day mortality was higher in open cases than laparoscopic, although there was no significant increase in the adjusted analysis. The adjusted Table 2 Pre-operative categorical patient characteristics Variables

Laparoscopic

Open

Prob

N

%

N

%

12,209

46.5

47730

52.7 \0.0001

Minority

4,871

18.7

19,474

21.7 \0.0001

Alcohol Shortness of breath

404 2,017

2.4 7.7

1,595 6,386

COPD

Male

2.6 7.0

0.118 0.001

1,123

4.3

3,951

4.4

0.561

Current pneumonia

12

0.1

79

0.1

0.050

Ascites

63

0.2

913

1.0 \0.0001

Esophageal varices

16

0.1

181

0.3 \0.0001

History of CHF

61

0.2

302

0.3

0.010

History of MI

22

0.1

74

0.1

0.760

History of PCI

731

4.3

2,609

4.3

0.717

History of cardiac surgery

693

4.1

2,475

4.1

0.736

49

0.3

209

0.3

0.302

12,870

49.0

40,312

172

1.0

636

1.0

0.810

9

0.1

29

0.0

0.759

166

0.6

917

1.0 \0.0001

8 57

0.0 0.3

74 231

0.1 0.4

0.009 0.447 0.051

History of angina HTN History of PVD Rest pain On dialysis Impaired sensorium Hemiplegia

44.4 \0.0001

History of TIA

305

1.8

973

1.6

History of CVA

160

1.0

640

1.1

0.259

CNS tumor

5

0.0

22

0.0

0.694

Paraplegia

17

0.1

104

0.2

0.043

9

0.1

32

0.1

0.961

0.5

0.902

Quadriplegia Disseminated cancer

119

0.5

416

Wound infection

176

0.7

1,446

1.6 \0.0001

Steroid use

608

2.3

2,340

2.6

0.015

Weight loss

96

0.4

353

0.4

0.581

622

2.4

2,652

Transfusion

27

0.1

153

0.2

Chemotherapy

56

0.3

218

0.4

0.630

Radiotherapy

11

0.1

64

0.1

0.143

2

0.0

85

0.2 \0.0001

84 14,651

0.5 55.7

496 47,417

0.8 \0.0001 52.3 \0.0001

Bleeding disorder

Pregnant Previous operation Any preop condition

2.9 \0.0001 0.016

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Surg Endosc Table 3 Pre-operative continuous characteristics

Variables

Laparoscopic N

N

26,286

Age

26,286

Mean

SD

N

55.0

13.9

90,721

Mean

SD

equal

53.9

14.8

\0.0001

90,721

Variances

BMI

26,011

33.4

7.9

89,450

32.0

7.9

\0.0001

20,314

139.3

2.7

65,393

139.2

2.9

\0.0001

Pre-operative BUN

19,580

16.0

8.2

62,947

16.6

9.4

\0.0001

Pre-operative serum creatinine

20,327

1.0

0.7

65,380

1.0

0.9

\0.0001

Pre-operative serum albumin

11,229

4.0

0.5

37,235

4.0

0.6

\0.0001

Pre-operative total bilirubin

11,251

0.6

0.6

37,910

0.7

0.7

\0.0001

Pre-operative SGOT

11,360

27.3

23.0

38,596

28.3

25.4

0.000

Pre-operative alkaline phosphatase

11260

82.2

35.7

37,959

84.8

44.2

\0.0001

Pre-operative WBC Pre-operative hematocrit

20,367 21,122

7.5 40.6

2.5 4.5

66,097 68,945

7.6 40.5

3.0 4.9

\0.0001 0.000

Pre-operative platelet count

\0.0001

20,320

244.3

71.7

65,949

240.7

75.9

Pre-operative PTT

5,664

29.6

5.9

20,678

29.8

6.4

0.046

Pre-operative INR

6,750

1.1

0.3

24,938

1.1

0.3

\0.0001

Pre-operative PT

4,104

12.5

3.2

15,516

12.8

3.3

\0.0001

Laparoscopic

Open

N

N

%

Prob

Table 5 Predictive pre-operative characteristics associated with increased morbidity Odds ratio estimates

%

Effect Mortality

p-values

Pre-operative serum sodium

Table 4 Post-operative morbidity Variable

Open

Return to OR

365

1.4

1,803

2.0

\0.0001

Pneumonia

141

0.5

639

0.7

0.0032

Open

1.63

1.38

1.92

Re-intubation

135

0.5

592

0.7

0.0116

Age

1.01

1.01

1.01

57

0.2

222

0.2

0.4148

BMI

1.03

1.02

1.03

5

0.0

94

0.1

\0.0001

BUN

1.01

1.01

1.02

Renal failure

25

0.1

198

0.2

\0.0001

Albumin

0.61

0.55

0.67

Renal insufficiency

35

0.1

208

0.2

0.0026

AST

1.00

1.00

1.00

217 39

0.8 0.1

757 133

0.8 0.1

0.8889 0.9476

WBC

1.06

1.04

1.07

HCT

0.97

0.96

0.98

MI

50

0.2

140

0.2

0.2031

PT

1.03

1.01

1.05

Transfusion

27

0.1

153

0.2

0.0163

Male

0.87

0.77

0.99

0

0.0

9

0.0

0.1063

SOB

1.37

1.17

1.62

DVT

62

0.2

300

0.3

0.0148

Pneumonia

2.48

1.28

4.81

Sepsis

135

0.5

789

0.9

\0.0001

CHF

1.98

1.25

3.14

Ventilator

Urinary tract infection Cardiac arrest

Graft

Septic shock Superficial incisional infection Deep incisional infection Organ space infection No complication

0.37

95 % Wald

0.23

Pulmonary embolism

334

Point estimate

61

0.0008

72

0.3

311

0.3

0.0851

168

0.6

2,173

2.4

\0.0001

52

0.2

788

0.9

\0.0001

102

0.4

434

0.5

0.056

25,108 95.5

83,757 92.3

\0.0001

analysis also showed less overall morbidity associated with laparoscopic repair. Our logarithmic regression analysis of pre-operative factors found that existing pneumonia,

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Confidence limits

Wound infection

2.69

2.11

3.43

Transfusion

3.08

1.62

5.83

congestive heart failure, wound infection, and pre-operative need for transfusion were associated with increased post-operative complication rates. This suggests that sicker patients with significant medical comorbidities develop more post-operative complications with open VHR. Our findings are consistent with a growing body of literature examining laparoscopic versus open VHR. In a variety of different study designs, fewer complications and

Surg Endosc

decreased LOS have been described. Newer randomized controlled trials have shown positive results but suffer from small sample sizes. Despite these promising reports and an overall movement toward less invasive techniques in the treatment of surgical diseases, our study suggests that the overall utilization of laparoscopic approaches to VHR remains low. Low utilization of laparoscopic VHR is in contrast with the wide use of laparoscopic techniques in many other complex surgical procedures. Ahad et al. reported a 66 % utilization of laparoscopy in splenectomy from 2005 to 2010 NSQIP data [22]. Analysis of adrenalectomy NSQIP data over the same time period by Elfenbein et al. showed a 79 % laparoscopic utilization [23]. In 2012, Simorov et al. reported the utilization of laparoscopic colon resection using the University Health System Consortium administrative database [24]. They found the rate of laparoscopic resection to be 40 % using data from 2008 to 2011. Interestingly, the use of laparoscopy was as high as 18 % in the urgent setting. All of these studies found advantages of laparoscopy similar to ours, including less morbidity and shorter LOS. Taken together, these data demonstrate the use of laparoscopy, even in complex operations, remains significantly higher than in VHR. The 18 % utilization of laparoscopic colectomy in the urgent setting alone was similar to the total use of laparoscopic VHR. The slight increase from 17 to 22 % we found over previous NSQIP data is not on par with other laparoscopic operations. Use of the NSQIP dataset allows for a cross-sectional analysis with large numbers of patients nationwide, and it is validated as a repository of 30-day outcomes. There are a number of limitations of analyses using this dataset. Sampling bias is possible since only three procedures are entered in every 8-day period. Given the prevalence of VHR, it is likely that some cases performed over the study period were not included. Currently, the NSQIP dataset does not include procedure-specific variables such as hernia size, exact location, type, and contents. It is not possible to comment on how those variables would affect the surgeon’s subsequent operative approach. NSQIP only tracks 30-day morbidity and mortality, meaning that we cannot comment on late complications or long-term recurrence. Finally, the dataset only includes patients from those hospitals participating in the ACS-NSQIP program, which may limit our ability to generalize the results. In conclusion, we found that the utilization of laparoscopic VHR remained low from 2009 to 2012 and continued to lag behind the use of laparoscopy in other complex surgical procedures. The mortality rate between laparoscopic and open VHR was similar, but laparoscopic repair was associated with lower overall complication rates. Additionally, we found that some high-risk patients,

as identified by several pre-operative factors, have fewer complications with laparoscopic VHR. Disclosures Chetan V Aher, John C Kubasiak, Shaun C Daly, Imke Janssen, Daniel J Deziel, Keith W Millikan, Jonathan A Myers, and Minh B Luu have no financial ties to disclose.

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The utilization of laparoscopy in ventral hernia repair: an update of outcomes analysis using ACS-NSQIP data.

Numerous prospective studies and randomized controlled trials have demonstrated shorter length of stay, lower morbidity rates, and similar recurrence ...
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