Biologic mesh for ventral hernia repair compared for recurrence, cost

The porcine acellular dermal mesh product Strattice was associated with significantly lower odds of hernia recurrence, compared with several other biologic mesh products, in a study of 223 patients who underwent open ventral hernia repair.

Prospective operative outcomes data from a tertiary referral hernia center showed that at a mean follow-up of 18.2 months, the rate of hernia recurrence was 35% in 40 patients who were treated with Alloderm (LifeCell Corporation), 34.5% in 23 patients treated with AlloMax (Bard/Davol), 37.1% in 70 patients treated with FlexHD (Ethicon), and 59.1% in 22 patients treated with Xenmatrix (Bard/Davol), compared with 14.7% in 68 patients treated with Strattice (LifeCell Corporation). Alloderm, AlloMax, and FlexHD are all human acellular dermal mesh products, and Strattice and Xenmatrix are both porcine acellular dermal mesh products, Ciara R. Huntington, MD, and her colleagues at the Carolinas Medical Center in Charlotte, N.C., reported.

Photo courtesy Acelity. STRATTICETM Reconstructive Tissue Matrix

After multivariate analysis to adjust for factors such as comorbidities, hernia size, and intraoperative techniques, the odds ratios for recurrence with each product as compared with Strattice were 2.4 with Alloderm, 2.9 with FlexHD, 3.4 with AlloMax, and 7.8 with Xenmatrix. The odds for recurrence were significantly greater with all except Alloderm, the investigators said (Surgery. 2016. doi: 10.1016/j.surg.2016.07.008).

The significant differences between the two porcine acellular dermal meshes (Xenmatrix and Strattice) may reflect variation in tissue processing and design in biomesh engineering, they noted.

Study subjects were adults with a mean age of 57.7 years and mean body mass index of 34.8 kg/m². Overall, 9.8% had an American Society of Anesthesiology classification of 4, 54.6% had a classification of 3, and 35.6% had a classification of 1 or 2. Average operative time was 241 minutes with estimated blood loss of 202 mL.

Average hernia defect size was 257 cm², with average mesh size of 384 cm².

“Component separation was performed in 47.5% of cases, and abdomen was left open prior to definitive closure in 10.7%. Biologic mesh was used to bridge fascial defects in 19.6% of cases. The mesh was placed in the preperitoneal space in 38.2% of cases,” the investigators wrote, noting that a concomitant procedure was performed in 82% of cases.

Sepsis developed in 6.7% of patients, 36.3% had a wound infection, and 24.3% required a negative pressure dressing for healing. The inpatient mortality rate was 1.4%.

However, mesh infections requiring explantation occurred in less than 1% of cases.

On adjusted analysis, Xenmatrix was the most expensive mesh and AlloMax was the least expensive (mean of $59,122 and $22,304, respectively). Strattice costs averaged $40,490.

Ventral hernia repair (VHR) is a common operation, with about 350,000 performed each year. Rates of postoperative wound infection and hernia recurrence vary widely, but may be improved with appropriate mesh selection. However, prospective data to guide selection are lacking, the investigators said.

“The great number of meshes available for use complicates the debate surrounding the best timing and use of biologic mesh in VHR, and the search for the better mesh for use in the abdominal wall reconstruction continues. Biologic mesh usually is reserved for the patients at the highest risk for developing a postoperative wound complication, and although there is a current dearth of high-level evidence supporting its use, this report confirms that complications are low despite obvious surgical complexity presented herein,” they wrote.

The findings of this study – the largest report of outcomes with biologic mesh in ventral hernia repair to date, according to the authors – support the safety of using biologic mesh in high-risk patients, they said.

They noted, however, that the study may still be underpowered to make final clinical decisions.

“Although our study provides useful information to the practicing surgeon, there is much work to be done regarding the selection of biologic mesh,” they wrote, adding that while “a well-performing biologic mesh should be in the toolkit of every general surgeon who may face complex abdominal walls requiring reconstruction in patients that are at high risk for a postoperative wound complication,” additional research is necessary to further clarify the role of biologic mesh in these operations.

Dr. Huntington reported having no disclosures. Other authors reported having been awarded honoraria, speaking fees, surgical research funding, and education grants from W.L. Gore and Associates, Ethicon, Novadaq, Bard/Davol, and LifeCell Corporation.

sworcester@frontlinemedcom.com

The porcine acellular dermal mesh product Strattice was associated with significantly lower odds of hernia recurrence, compared with several other biologic mesh products, in a study of 223 patients who underwent open ventral hernia repair.

Prospective operative outcomes data from a tertiary referral hernia center showed that at a mean follow-up of 18.2 months, the rate of hernia recurrence was 35% in 40 patients who were treated with Alloderm (LifeCell Corporation), 34.5% in 23 patients treated with AlloMax (Bard/Davol), 37.1% in 70 patients treated with FlexHD (Ethicon), and 59.1% in 22 patients treated with Xenmatrix (Bard/Davol), compared with 14.7% in 68 patients treated with Strattice (LifeCell Corporation). Alloderm, AlloMax, and FlexHD are all human acellular dermal mesh products, and Strattice and Xenmatrix are both porcine acellular dermal mesh products, Ciara R. Huntington, MD, and her colleagues at the Carolinas Medical Center in Charlotte, N.C., reported.

Photo courtesy Acelity. STRATTICETM Reconstructive Tissue Matrix

After multivariate analysis to adjust for factors such as comorbidities, hernia size, and intraoperative techniques, the odds ratios for recurrence with each product as compared with Strattice were 2.4 with Alloderm, 2.9 with FlexHD, 3.4 with AlloMax, and 7.8 with Xenmatrix. The odds for recurrence were significantly greater with all except Alloderm, the investigators said (Surgery. 2016. doi: 10.1016/j.surg.2016.07.008).

The significant differences between the two porcine acellular dermal meshes (Xenmatrix and Strattice) may reflect variation in tissue processing and design in biomesh engineering, they noted.

Study subjects were adults with a mean age of 57.7 years and mean body mass index of 34.8 kg/m². Overall, 9.8% had an American Society of Anesthesiology classification of 4, 54.6% had a classification of 3, and 35.6% had a classification of 1 or 2. Average operative time was 241 minutes with estimated blood loss of 202 mL.

Average hernia defect size was 257 cm², with average mesh size of 384 cm².

“Component separation was performed in 47.5% of cases, and abdomen was left open prior to definitive closure in 10.7%. Biologic mesh was used to bridge fascial defects in 19.6% of cases. The mesh was placed in the preperitoneal space in 38.2% of cases,” the investigators wrote, noting that a concomitant procedure was performed in 82% of cases.

Sepsis developed in 6.7% of patients, 36.3% had a wound infection, and 24.3% required a negative pressure dressing for healing. The inpatient mortality rate was 1.4%.

However, mesh infections requiring explantation occurred in less than 1% of cases.

On adjusted analysis, Xenmatrix was the most expensive mesh and AlloMax was the least expensive (mean of $59,122 and $22,304, respectively). Strattice costs averaged $40,490.

Ventral hernia repair (VHR) is a common operation, with about 350,000 performed each year. Rates of postoperative wound infection and hernia recurrence vary widely, but may be improved with appropriate mesh selection. However, prospective data to guide selection are lacking, the investigators said.

“The great number of meshes available for use complicates the debate surrounding the best timing and use of biologic mesh in VHR, and the search for the better mesh for use in the abdominal wall reconstruction continues. Biologic mesh usually is reserved for the patients at the highest risk for developing a postoperative wound complication, and although there is a current dearth of high-level evidence supporting its use, this report confirms that complications are low despite obvious surgical complexity presented herein,” they wrote.

The findings of this study – the largest report of outcomes with biologic mesh in ventral hernia repair to date, according to the authors – support the safety of using biologic mesh in high-risk patients, they said.

They noted, however, that the study may still be underpowered to make final clinical decisions.

“Although our study provides useful information to the practicing surgeon, there is much work to be done regarding the selection of biologic mesh,” they wrote, adding that while “a well-performing biologic mesh should be in the toolkit of every general surgeon who may face complex abdominal walls requiring reconstruction in patients that are at high risk for a postoperative wound complication,” additional research is necessary to further clarify the role of biologic mesh in these operations.

Dr. Huntington reported having no disclosures. Other authors reported having been awarded honoraria, speaking fees, surgical research funding, and education grants from W.L. Gore and Associates, Ethicon, Novadaq, Bard/Davol, and LifeCell Corporation.

sworcester@frontlinemedcom.com

The porcine acellular dermal mesh product Strattice was associated with significantly lower odds of hernia recurrence, compared with several other biologic mesh products, in a study of 223 patients who underwent open ventral hernia repair.

Prospective operative outcomes data from a tertiary referral hernia center showed that at a mean follow-up of 18.2 months, the rate of hernia recurrence was 35% in 40 patients who were treated with Alloderm (LifeCell Corporation), 34.5% in 23 patients treated with AlloMax (Bard/Davol), 37.1% in 70 patients treated with FlexHD (Ethicon), and 59.1% in 22 patients treated with Xenmatrix (Bard/Davol), compared with 14.7% in 68 patients treated with Strattice (LifeCell Corporation). Alloderm, AlloMax, and FlexHD are all human acellular dermal mesh products, and Strattice and Xenmatrix are both porcine acellular dermal mesh products, Ciara R. Huntington, MD, and her colleagues at the Carolinas Medical Center in Charlotte, N.C., reported.

Photo courtesy Acelity. STRATTICETM Reconstructive Tissue Matrix

After multivariate analysis to adjust for factors such as comorbidities, hernia size, and intraoperative techniques, the odds ratios for recurrence with each product as compared with Strattice were 2.4 with Alloderm, 2.9 with FlexHD, 3.4 with AlloMax, and 7.8 with Xenmatrix. The odds for recurrence were significantly greater with all except Alloderm, the investigators said (Surgery. 2016. doi: 10.1016/j.surg.2016.07.008).

The significant differences between the two porcine acellular dermal meshes (Xenmatrix and Strattice) may reflect variation in tissue processing and design in biomesh engineering, they noted.

Study subjects were adults with a mean age of 57.7 years and mean body mass index of 34.8 kg/m². Overall, 9.8% had an American Society of Anesthesiology classification of 4, 54.6% had a classification of 3, and 35.6% had a classification of 1 or 2. Average operative time was 241 minutes with estimated blood loss of 202 mL.

Average hernia defect size was 257 cm², with average mesh size of 384 cm².

“Component separation was performed in 47.5% of cases, and abdomen was left open prior to definitive closure in 10.7%. Biologic mesh was used to bridge fascial defects in 19.6% of cases. The mesh was placed in the preperitoneal space in 38.2% of cases,” the investigators wrote, noting that a concomitant procedure was performed in 82% of cases.

Sepsis developed in 6.7% of patients, 36.3% had a wound infection, and 24.3% required a negative pressure dressing for healing. The inpatient mortality rate was 1.4%.

However, mesh infections requiring explantation occurred in less than 1% of cases.

On adjusted analysis, Xenmatrix was the most expensive mesh and AlloMax was the least expensive (mean of $59,122 and $22,304, respectively). Strattice costs averaged $40,490.

Ventral hernia repair (VHR) is a common operation, with about 350,000 performed each year. Rates of postoperative wound infection and hernia recurrence vary widely, but may be improved with appropriate mesh selection. However, prospective data to guide selection are lacking, the investigators said.

“The great number of meshes available for use complicates the debate surrounding the best timing and use of biologic mesh in VHR, and the search for the better mesh for use in the abdominal wall reconstruction continues. Biologic mesh usually is reserved for the patients at the highest risk for developing a postoperative wound complication, and although there is a current dearth of high-level evidence supporting its use, this report confirms that complications are low despite obvious surgical complexity presented herein,” they wrote.

The findings of this study – the largest report of outcomes with biologic mesh in ventral hernia repair to date, according to the authors – support the safety of using biologic mesh in high-risk patients, they said.

They noted, however, that the study may still be underpowered to make final clinical decisions.

“Although our study provides useful information to the practicing surgeon, there is much work to be done regarding the selection of biologic mesh,” they wrote, adding that while “a well-performing biologic mesh should be in the toolkit of every general surgeon who may face complex abdominal walls requiring reconstruction in patients that are at high risk for a postoperative wound complication,” additional research is necessary to further clarify the role of biologic mesh in these operations.

Dr. Huntington reported having no disclosures. Other authors reported having been awarded honoraria, speaking fees, surgical research funding, and education grants from W.L. Gore and Associates, Ethicon, Novadaq, Bard/Davol, and LifeCell Corporation.

sworcester@frontlinemedcom.com