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An evaluation of clinical and quality of life outcomes after ventral hernia repair with poly-4-hydroxybutyrate mesh

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Abstract

Purpose

Despite continued efforts, recurrence after ventral hernia repair (VHR) remains a common problem. Biosynthetic Phasix™ (Poly-4-Hydroxybutyrate, P4HB) mesh combines the durability of synthetic mesh with the bio-resistance of biologics. P4HB has shown promising early outcomes, but long-term data are lacking. We examine patients following VHR with P4HB with at least 3 years of follow-up to assess clinical and patient reported outcomes (PROs).

Methods

Adult patients (≥ 18 years old) undergoing VHR with P4HB mesh between 10/2015 and 01/2018 by a single surgeon were retrospectively identified. Patients with < 36 months of follow-up were excluded unless they had a documented recurrence. Clinical outcomes and quality of life using the Hernia-Related Quality of Life Survey (HerQLes) were assessed.

Results

Seventy-one patients were included with a median age and body mass index of 61.2 and 31 kg/m2, respectively. Mesh was placed in the retromuscular (79%) and onlay (21%) planes with 1/3 of patients having hernias repaired in contaminated fields. There were no mesh infections, enterocutaneous fistulas, or mesh explantations. Nine patients (12.7%) developed recurrence at a median follow-up of 43.1 months [38.2–49.1]. Mesh plane, fixation technique, and Ventral Hernia Working Group were not associated with recurrence. Significant improvement in disease-specific PROs was observed and maintained at 3-year follow-up.

Conclusion

Longitudinal clinical and quality of life outcomes after clean and contaminated VHR with P4HB are limited. Here, we conclude that P4HB is an effective and versatile mesh option for use in abdominal wall reinforcement.

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Abbreviations

VH:

Ventral hernias

QoL:

Quality of life

VHR:

Ventral hernia repair

P4HB:

Phasix™ (Poly-4-Hydroxybutyrate)

PROs:

Patient-reported outcomes

HTN:

Hypertension

DM:

Diabetes mellitus

CAD:

Coronary artery disease

VHWG:

Ventral Hernia Working Group

ASA:

American Society of Anesthesiology

CDC:

Center for Disease Control

SSO:

Surgical site occurrence

SSI:

Surgical site infection

SSOPI:

Surgical site occurrence requiring procedural intervention

HerQLes:

Hernia-related Quality-of-life Survey

VHS:

Validated hernia survey questionnaire

CT:

Computed Tomography

EMR:

Electronic Medical Record

REDCap:

Research Electronic Data Capture

IQR:

Interquartile ranges

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Acknowledgements

The authors would like to acknowledge the patients included in this study as well as the following physicians for their assistance in the operations: Lori Cory, MD, Daniel T. Dempsey, MD, Kristoffel Dumon, MD, Robert L. Giuntoli, MD, Ashley F. Haggerty, MD, Sean P. Harbison, MD, Willian I. Jaffe, MD, Gary Korus, MD, Stanley B. Malkowicz, MD, Francis E. Rosato, MD, Skandan Shanmugan,MD, Carrie A. Sims, MD, Michael Tiller, MD, Noel Williams, MD.

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Authors and Affiliations

  1. Division of Plastic Surgery, Department of Surgery, University of Pennsylvania Health System, Penn Presbyterian Hospital, 51 North 39th Street, Wright Saunders Building, Philadelphia, PA, 19104, USA

    A. N. Christopher, M. P. Morris, J. A. Mellia, R. B. Broach & J. P. Fischer

  2. Department of Surgery, Thomas Jefferson University, Philadelphia, PA, USA

    A. N. Christopher

  3. Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

    V. Patel & C. Fowler

  4. H. Wayne Huizenga School of Business and Entrepreneurship, Nova Southeastern University, Davie, FL, USA

    C. A. Messa IV

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  1. A. N. Christopher
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  4. J. A. Mellia
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Corresponding author

Correspondence to J. P. Fischer.

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Funding

Not applicable.

Conflicts of Interest/Competing Interest

JPF has received funding and consulting fees from Becton-Dickinson, Integra, Gore and Baxter.

Ethical approval

The study protocol was reviewed and approved by the University of Pennsylvania Institutional Review Board (IRB#844684).

Human and Animal Rights

No animals were used for this study.

Informed consent

Due to the retrospective nature of the study, informed consent was waived.

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All data and materials comply with field standards.

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All statistical analysis was performed using STATA and is available upon request.

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by ANC, MPM, VP, CF, JPM, CM, and RB. The first draft of the manuscript was written by ANC and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Christopher, A.N., Morris, M.P., Patel, V. et al. An evaluation of clinical and quality of life outcomes after ventral hernia repair with poly-4-hydroxybutyrate mesh. Hernia 25, 717–726 (2021). https://doi.org/10.1007/s10029-021-02394-9

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  • DOI: https://doi.org/10.1007/s10029-021-02394-9

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