New Study Reports Excellent Patient Outcomes with No Reinterventions at Two Years in Patients Who Underwent Laparoscopic Paraesophageal Hernia Repair Utilizing MIROMESH® Biologic Matrix
A new study published in The American Journal of Surgery demonstrates improved long-term patient outcomes, with no reinterventions, and a 10% two-year radiographic recurrent rate when MIROMESH® Biologic Matrix was utilized for crural reinforcement during laparoscopic paraesophageal hernia repair (PEHR). In this multi-center, single-arm study, symptoms of gastroesophageal reflux disease (GERD) as measured by the GERD-HRQL instrument were significantly improved from baseline to two-year follow-up, 19.3 to 3.8 respectively (p < 0.0001). At two years post surgery, 89% of patients reported satisfaction with their condition versus only 17.9% reporting satisfaction pre-operatively. Quality of life scores also significantly improved from baseline to 24-month follow up, including statistically significant improvements in physical function (p < 0.0138), social function (p < 0.0178), and physical component summary score (p < 0.0468).
“This study showed laparoscopic paraesophageal hernia repair utilizing MIROMESH resulted in a durable repair with excellent patient outcomes,” says Michael J. Rosen, MD, Cleveland Clinic and the study’s primary investigator. “Given these encouraging findings, MIROMESH can be considered an effective surgical option when a biologic graft is felt to be necessary for crural reinforcement during these procedures.”
This peer-reviewed surgical publication reports the complete results of 41 subjects who underwent a laparoscopic PEHR that included primary crural closure with a MIROMESH onlay for reinforcement. All patients had a laparoscopic transabdominal approach, and none required conversion to an open procedure. The mean operative time was 142.6 minutes, and the mean length of stay was three days. There were no major intraoperative complications reported. Clinical and radiologic follow up were available in 38 patients at two weeks, 30 at 12 months, and 27 at two years. Subjects were assessed at two weeks and six, 12, 18 and 24 months using validated quality of life and GERD symptom questionnaires.
Follow up was not only symptomatically evaluated but also radiographically, with objective definitions of hernia recurrence. Upper gastrointestinal (UGI) radiologic evaluation was performed preoperatively and postoperatively at day 1, one year and two years. Radiologic evaluation demonstrated small anatomic hiatal hernia recurrences (2 to 3 cm) in three patients; none of these patients required surgical reintervention. A Kaplan-Meier Analysis used to estimate the rate of anatomic recurrence for the entire study cohort showed a 10% (95% CI, 3-29%) rate of anatomic recurrence.
“This was a high-quality, prospective study of MIROMESH completed by physicians who are thought leaders in the laparoscopic repair of paraesophageal hernias,” says Jeff Ross, Ph.D., CEO of Miromatrix. “The two-year results showed a low rate of anatomic recurrence that did not require surgical reintervention, and nearly 90% of patients remained satisfied with their outcomes. These positive results should provide physicians with confidence to consider MIROMESH for crural reinforcement in appropriate patients.”
The complete publication, titled “A multi-center, prospective clinical trial of a hepatic derived porcine surgical mesh for the laparoscopic repair of symptomatic paraesophageal hernias,” is now available epub ahead of print in The American Journal of Surgery.