One of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in older patients. Patients are often present for surgery after decades of chronic reflux disease and a known hiatal hernia that has finally progressed to a complete intrathoracic stomach with symptoms concerning a gastric volvulus. Surgery in such patients involves extensive mediastinal dissection to reduce the large hernia sac, repositioning of the gastroesophageal junction into the abdomen, and then repair of a significantly attenuated defect in older patients with attenuated diaphragmatic muscle integrity. Current surgical approaches, with or without prosthetic material, anticipate a recurrence rate of at least 40% to 50% at 5 years, even among skilled surgeons.1–3 In fact, despite the availability and failed success of both absorbable and permanent mesh, primary repair of the hiatus remains the mainstay of surgical treatment for PEH. Challenges with PEH repair are multifactorial and include primary closure of weakened crural muscle in a large attenuated diaphragmatic defect; the absence of a substantial fascial layer to use to close the defect; and the avoidance of permanent mesh due to the risk of shrinkage, dysphagia and esophageal erosion. Although a tension-free repair is the goal, the use of relaxing incisions, fixation to posterior structures (ie, Hill procedure), and other such modifications have not proven to be universally beneficial.4,5

In this report, we describe the initial results of a novel permanent autologous vascularized biological fascial flap to reconstruct the diaphragmatic hiatus after standard hiatal hernia repair in selected patients. We call this technique a posterior rectus sheath flap hiatal augmentation or posterior rectus sheath hiatal flap augmentation (PoRSHA), which is performed to enhance the hiatal repair for large (type III and IV) and recurrent PEH.6 We believe by using the patient’s autologous vascularized and peritonealized fascia at the hiatal defect, PoRSHA could increase the strength and restore the hiatal complex properties in ways that synthetic mesh or a primary repair cannot (Fig. 1). The aims of this study were to evaluate and implement this technique by using the IDEAL (Idea, Development, Exploration, Assessment, and Long-term follow-up) framework7,8 for surgical innovation, to determine its safe development and early evaluation as a surgical innovation through a Phase 2a9 report.

FIGURE 1:

Intraoperative flap placement. A, Donor site at the right anterior abdominal wall. B, Harvested posterior rectus sheath flap transposed to the hiatus. C, Posterior incorporation of the posterior rectus sheath flap. D, Circumferential incorporation of the posterior rectus sheath flap.

METHODS Design

This is a prospective single-center prospective case series of the first 27 patients who underwent posterior rectus sheath flap hiatal augmentation, PoRSHA (Table 1). Iterative modifications to the technique during this development phase (IDEAL Phase 2a) were recorded and are reported here.

TABLE 1 - Patient Characteristics Pt No. Age (y) Sex BMI (kg/m2) Type of PEH Preop imaging (barium swallow unless otherwise indicated) Original operation Previous mesh 1 67 M 25.8 III Nonobstructive mixed type volvulus — — 2 72 F 29.4 Recurrent Recurrent 3 cm hernia 2020 Toupet Yes, BioA 3 70 F 22.4 IV Nonobstructive organoaxial volvulus — — 4 75 F 30 III Nonobstructive organoaxial volvulus — — 5 77 F 24.5 III Nonobstructive mesoaxial Volvulus* — — 6 75 F 23.7 IV Entire stomach, transverse, and descending colon within hernia* — — 7 69 F 37 Recurrent Recurrent hernia, moderate sized 2020 Nissen Yes, BioA 8 73 F 26.2 Recurrent Intrathoracic wrap, epiphrenic diverticulum 2016 Nissen No 9 68 F 22.8 IV Nonobstructive organoaxial volvulus* — — 10 77 M 26 Recurrent Intrathoracic fundoplication, moderate sized 2008 Nissen Unknown 11 78 F 33.4 III Partial intrathoracic stomach — — 12 72 M 22.5 III 5.2 cm hernia, long midthoracic benign stricture — — 13 75 F 23.1 IV Mixed type nonobstructive volvulus — — 14 62 F 34.8 Recurrent Recurrent 6 cm hernia, no evidence of wrap 2021 PEH Repair with colon injury, aborted TIF Yes, BioA 15 80 F 22.3 III Gastric fundus and body within hernia — — 16 72 F 28 IV Intrathoracic stomach — — 17 71 F 27.8 III No volvulus, paraesophageal hernia — — 18 70 F 24.6 Recurrent Recurrent sliding hernia, possible disrupted wrap 2018 Nissen Unknown 19 71 F 27.5 III Partial intrathoracic stomach — — 20 76 M 27.4 IV Intrathoracic stomach, nonobstructive mixed type volvulus — — 21 78 F 24.4 III Partial intrathoracic stomach — — 22 62 F 35.3 III Nonobstructive organoaxial volvulus* — — 23 54 M 33.9 Recurrent Nissen intact, herniation of stomach 2003 Nissen Unknown 24 75 M 27.4 Recurrent Fundoplication disrupted and herniated 2015 Nissen No 25 75 M 33 III Partial intrathoracic stomach — — 26 67 F 29.9 IV Intrathoracic stomach with partial obstruction — — 27 69 M 20.3 III Partial intrathoracic stomach* — —

*CT imaging.

BMI indicates body mass index; TIF, transoral incisionless fundoplication.

Participants

From February 2021 to October 2023, patients referred to our single institution for repair of a large or recurrent PEH were considered for this novel repair approach. During this developmental period, the eligibility for this technique was considered by consensus of all co-authors. Initially, PoRSHA was only offered to patients with long-standing type IV defects or difficult revisional cases. As our experience grew, we broadened the eligibility criteria to include patients with PEH measuring >5 cm as determined by preoperative radiologic imaging. Intraoperatively, the defect was re-evaluated along with the quality of the tissue. Ultimately, it was left to the surgeon’s discretion to proceed with PoRSHA. We excluded patients who had previous alterations to their abdominal wall (prior laparotomy, current/previous abdominal wall hernias) or required emergent repair for gastric volvulus. We also excluded patients requiring therapeutic anticoagulation perioperatively or those with bleeding disorders, considering the added risk of bleeding at the donor site with exposed rectus muscle (Fig. 1A).

All patients provided written informed consent and were informed of the novelty and early experience of this technique, and the unknown results of this procedure in addition to that of traditional reduction of the hernia and fundoplication. Patients were informed of the unknown risks of harvesting the posterior rectus sheath, which included but was not limited to the risk of abdominal wall hernia/eventration and adhesions formation or bleeding at the donor site.

Perioperative Care

All patients in this series followed the traditional foregut surgery pathway as established at the University of Chicago minimally invasive surgery service. The only exception was specific attention preoperatively to the abdominal wall exam to detect any abdominal wall hernias. Our standardized foregut recovery pathways were used, including perioperative mechanical and chemical venous thromboembolism prophylaxis, aggressive use of anti-emetics and diet advancement on postoperative day 0. Proton pump inhibitors were stopped on postoperative day 1 in the absence of Barrett esophagus or erosive disease.

Patients in this series had specific safety monitoring protocols in place to guard against adverse events or side effects. These included comprehensive postoperative abdominal exams evaluating for ecchymosis, excess abdominal tenderness, and/or abdominal eventration or weakness. Patients were contacted by phone 1 to 2 weeks after discharge to evaluate for any unusual symptoms, and the attending surgeon was notified of any complaints. Patient charts were reviewed every 2 to 3 months to evaluate for unexpected medical procedures or evaluations.

Outcome

The primary clinical outcome measured was radiologic recurrence of hiatal hernia. As per routine on our service for patients with very large hiatal defects, all PoRSHA patients underwent routine surveillance with barium swallow at approximately 6 months and 2 years. Barium swallows were performed by experienced gastroenterology radiologists with our standardized esophageal protocol to evaluate the esophagogastric junction and repair in complex hernia repairs. Using metrics as first defined by Lidor et al10 and now used for standardization among studies,1,11 recurrence was reported based on the barium swallow maximum vertical height >2 cm.

Secondary outcomes measured included solid food dysphagia, abdominal wall symptoms, presence of abdominal wall hernia, and need for abdominal surgery. All patients had follow-up at 1 month, 6 months, and then annually after the procedure for symptom evaluation, physical exam, and updated medical and surgical history.

RESULTS

A total of 27 patients were selected as candidates for PoRSHA (Table 1). This included recurrent (n=7), type III (n = 12), and type IV (n=8) hernias. The first 5 cases were performed robotic assisted (DaVinci Xi Robot), as previously described,6 with 2 high-volume foregut surgeons in conjunction with an experienced microvascular reconstructive plastic surgeon who first described the technique for pediatric liver transplantation.12,13 Twenty-two of the cases were performed by a single surgeon, and 5 cases were performed by a second surgeon adopting the technique. During this period, the PoRSHA technique went through iterative modifications, which are categorized into 3 steps: port placement, flap harvest, and hiatal repair. There were no modifications to the other aspects of the traditional method of repair of a giant PEH at the University of Chicago, which include hernia sac dissection, total sac excision, and establishment of at least 3 cm of intra-abdominal esophagus below the diaphragmatic hiatus.

Port Placement

As experience with the technique grew, port placement evolved to minimize external collisions with the robotic arms during flap harvest. While the hiatal hernia dissection and repair occur in the left upper quadrant and epigastrium, harvest of the flap occurs in the right upper quadrant and right central abdomen. This requires careful positioning of the robotic elbows at the beginning of the case or readjustment of the robotic elbows at the bedside when shifting quadrants to successfully complete the harvest.

Working ports. Two different port placements were particularly helpful to maximize visualization and minimize collisions, depending on which energy devices are used. The ports can be placed quite low with robotics to allow for the same ports to be used at the hiatus and for the flap harvest. However, as a shorter instrument, if the harmonic scalpel is the preferred energy device, port placement in Figure 2A is recommended. If the harmonic scalpel is not used, port placement as seen in Figure 2B is recommended.

FIGURE 2:

Port placement. A, Recommended port placement with the use of harmonic scalpel energy device. B, Port placement with the use of vessel sealer extend, synchroseal or other robotic energy device. Flap donor site is depicted in gray.

Camera placement. Unlike robotic instruments, the robotic camera does not articulate and thus must be placed carefully to allow for adequate visualization. Thus, the camera can be placed in the traditional placement for hiatal repair and then repositioned into the lower lateral port (port C) for the flap harvest if needed. Over time, it was observed that patients with lower body mass index and lower intra-abdominal adipose tissue tended to accommodate a more caudal placement of the camera, without compromising posterior crura visualization and made for easier visualization of the flap. Unlike patients who had significant intra-abdominal adipose, recurrent hernias and significant adhesions requiring extensive/difficult dissection of the posterior crus, in which traditional camera placement was necessary.

Flap Harvest

The novel concept of using the posterior rectus sheath vascularized through the falciform ligament was initially developed to reconstruct the recipient abdominal wall during liver transplantation.12,13 This flap was then modified to be harvested as an autologous peritonealized fascial flap for an MIS PEH repair while maintaining abdominal wall integrity and minimizing any donor site morbidity. This required following the strict principle of not violating the structural components of the abdominal wall, linea alba, and linea semilunaris.

The posterior rectus sheath is harvested from the patient’s anatomic right side, given its connection to and the projection of the falciform ligament which lies central toward the right side. The lateral extent of the posterior rectus sheath flap dissection is the linea semilunaris, which is just medial to the lateral neurovascular bundles of the rectus muscle and further marked by the transverse muscle fibers on the inner surface of the posterior sheath. The lateral edge then follows the shape of the rectus muscle, progressively moving more medial as the rectus muscle narrows along its cranial length.

The inferior edge lies just superior to, or at the level of, the umbilicus and is developed medially across the body of the rectus muscle and across the vascular pedicle. The medial extent of the flap is linea alba, where the medial edge of posterior rectus sheath is incised without violating linea alba. However, the vascular pedicle within the falciform/round ligament lies posterior to linea alba. Thus, after incising the medial border of the posterior rectus sheath, linea alba is preserved by continuing the dissection around the falciform ligament/vascular pedicle within the peritoneal plane (Fig. 3). These dissection planes are continued cranially to reach the avascular portion of the falciform ligament and completed by the mobilizing the pedicle towards the lateral fissure of the liver (Fig. 4C).

FIGURE 3:

Flap dissection. The flap and vascular pedicle free from the donor site are depicted on the left, with the pedicle still attached to the liver through the maintained falciform. The inset is a cross-sectional depiction of the inferior edge of the dissection plane. Both linea semilunaris and linea alba are preserved during this dissection while leaving the vascular pedicle attached to the posterior rectus sheath within the peritoneal layer.

FIGURE 4:

Intraoperative harvest. A, Harvested posterior rectus sheath flap with vascular pedicle. B, Indocyanine green angiography demonstrating the maintained blood supply through the pedicle. C, Vascular pedicle released from the avascular falciform. D, Vascular pedicle rotated through lateral fissure under the left lobe of the liver to the hiatus with retractor in place.

The harvested flap is rotated under the left lobe of the liver for use at the diaphragm, with the peritoneal surface facing intra-abdominally. The vascular pedicle is brought through the lateral fissure of the liver without twisting to prevent any tension on the pedicle (Fig. 4D). Removal of the retractor is not necessary to accommodate the rotation of the flap; however, in select cases, loosening or repositioning the liver retractor will be necessary to rotate the flap and pedicle toward the hiatus without tension. When required, repositioning of the liver retractor is minimal and does not impact the visualization of the hiatus. Of note, when the retractor is first placed, care should be taken to avoid the vascular pedicle and should be placed away and to the left of the falciform.

At any point during this dissection the use of indocyanine green (ICG) angiography can assist in the identification of the blood supply to the flap and provide guidance for the vascular pedicle dissection (Fig. 4B). We found this most useful when there was significant preperitoneal adipose tissue. Excess adipose tissue on the flap or pedicle can make incorporation more challenging due to lack of proper visualization of the vascular pedicle and the rectus sheath itself. NOTE: It is assumed that maintaining an adequate blood supply, as judged by ICG visualization, is required for a viably functioning graft.

Hiatal Repair

Supplemental Table 1, Supplemental Digital Content 1, https://links.lww.com/SLA/F20 describes the iterative modifications made throughout the series to the repair and flap placement itself to achieve technique stability after patient number 16. As the technique matured, we found that the flap could provide the most strength as incorporated onlay within the crural closure itself. Due to the difficulty of visualizing the crura with an incorporated technique, the technique evolved from an interrupted braided suture closure to a running barbed suture technique. We found that incorporating the flap eliminated the need for pledgets, as it acted as buttress when incorporated into the closure. Lastly, we noted that a running horizontal mattress suture allowed for a nonischemic closure of the crura with incorporating the sheath. The current iteration of our technique is to incorporate the fascial flap into the cruroplasty with a running permanent barbed horizontal mattress suture while stretching the sheath across the diaphragm and securing the edge to the diaphragm with a running barbed suture. With a large enough flap, it can be constructed and secured snug around the esophagus with excellent circumferentially purchase and even incorporated into an anterior cruroplasty (Fig. 1D). NOTE: visually, the flap is substantially thick and at least by visualization and handling, appears to be of the significant tensile strength (Fig. 1B).

While Fig. 5A demonstrates the most common iteration; at times, modification of the technique was necessary for specific patient characteristics. For example, in some cases, only a narrow piece of posterior rectus sheath can be harvested. When this is the case, the flap is still incorporated into the cruroplasty, without a full onlay onto the diaphragm (Fig. 5B). We found this configuration still appears to provide significant strength to the repair with similar outcome. A second modification we have employed is when the pedicle (ie, falciform containing the blood supply) is too short to be fully mobilized for posterior placement and/or the right crus is particularly attenuated, the flap is placed “right-sided” in the “C” position (Fig. 5C).

FIGURE 5:

Posterior rectus sheath flap placement. A, Incorporated circumferential onlay position with pedicle placed posteriorly. B, Incorporated into closure posteriorly only, as a large pledget. C, Incorporated onlay, right-sided C orientation with lateral pedicle placement. D, Relaxing incisions demonstrated with the dotted outline bilaterally covered with the flap.

Lastly, if a large onlay flap can be harvested, performing relaxing incisions in the crura is very easy and nicely suited for this technique. In 3 patients in this series, there was excessive tension encountered on the cruroplasty, and thus relaxing incisions were felt to be appropriate. These incisions reduced the tension on the cruroplasty, and the edge of the flap was used to cover and reconstruct the diaphragm at these relaxing incisions without the need for additional materials or mesh (Fig. 5D).

Patient Outcomes

After PoRSHA, no radiologic recurrences were detected at an average of 11.2 months (4–29 months) as described by the barium swallow consensus protocol above. Two patients had a vertical distance <2 cm above the diaphragm on these studies, but similar to the methodology outlined by others,1,10 this was considered within the normal range for this exam. At routine clinical follow-up, no patients had clinical recurrence of symptoms, and 1 patient experienced occasional solid dysphagia at 6 months that resolved with dilation. No abdominal eventration or hernias were detected on exam, and no patients had symptoms from the donor site. One patient presented with repair of a small <1.5 cm periumbilical hernia 2 years after PoRSHA. This hernia was inferior to the donor site and may have been present preoperatively. Two patients were lost to follow-up (Pt no. 9 and 15).

Operative Data

Early in the series, this technique added about 1 hour to the operative time due to our diligence to define the abdominal wall anatomy and develop the correct technique to harvest the flap. However, after 5 cases, anatomic and technical details were better understood, and the harvest added, on average, 15 to 20 minutes to the operative time. The surgeons involved in the cases herein described were all advanced MIS surgeons with extensive experience in hiatal hernia repair, robotic surgery, and abdominal wall anatomy. That said, for MIS surgeons with a similar experience, understanding and performing the technique should be similarly facilitated with proper proctoring.

Complications

Throughout this case series, safety was carefully monitored without concerns. Addition of PoRSHA to a standard PEH repair did not result in an increased risk of mortality or major morbidities. We found that patients had a very similar recovery (ie, length of stay, postoperative pain) and we did not observe any change in our fast-track protocol. There was one major complication of a postoperative pulmonary embolism (Pt no. 10). This was diagnosed before discharge and the patient was placed on therapeutic anticoagulation and oxygen on discharge. There was one readmission for a postoperative hypertensive crisis (Pt no. 9). Three patients developed postoperative abdominal wall ecchymosis that could potentially be attributed to the flap harvest itself. These were noted several days after the initial surgery but were self-limited and resolved within a few weeks of the operation.

DISCUSSION

Large and recurrent PEH repairs remain a difficult challenge for surgeons. Although highly experienced surgeons are heavily invested in these complex and time-intensive repairs, recurrence still occurs in almost 50% of cases. Despite the availability of numerous techniques and prosthetic materials, recurrence rates have not changed in decades.2,3,14,15 Furthermore, due to complications of placing prosthetic material around the esophagus,16,17 most surgeons have abandoned the use of these materials and perform a standard cruroplasty instead for large PEHs with a fundoplication.14

Yet standard cruroplasty portends a high fatigue rate and is assumed to be due to the size of the hernia, attenuation of the tissues and the subsequent tension on the muscular crural pillars during a repair. A major principle of any hernia repair involves understanding that the muscular defect cannot and should not rely on the strength of the muscle itself but instead on its investing fascia’s tensile strength. For example, when a laparotomy incision is closed, the abdominal wall’s strength is never restored by primarily approximating the rectus muscle alone but rather requires approximating its investing fascia. However, at the diaphragmatic hiatus with a long-standing and large hiatal hernia, there is no investing fascia of any quality to use for the closure. As a result, approximating the crural muscle alone as part of a standard hiatal hernia repair, not only violates the very tenets of hernia repair but, in select cases, results in a near 50% long-term failure rate.

PoRSHA is a unique technique that has the potential to supplant current approaches to primary hiatal closure in select cases. By augmenting the hiatal closure with a vascularized fascial sheath, PoRSHA provides the tensile strength needed for attenuated defects in large and complex PEHs. While we have seen other augmentations with absorbable or permanent mesh fail, PoRSHA stands alone as a unique solution as a permanent biological material. Unlike absorbable mesh, PoRSHA has the potential to remain as a durable repair for the lifetime of the patient. On the other hand, unlike permanent mesh that carries the proinflammatory effects of foreign material and its attendant “shrinkage” effect at the hiatus, PoRSHA is a material in which the peritoneal surface faces toward the intrabdominal structures while the basolateral layer adheres to the diaphragmatic repair. In addition, even when placing the autologous fascia snug around the esophagus, we have not observed any cases of severe dysphagia or erosion. Finally, given this is a large and thick piece of vascularized “living” fascia (often around 6 × 8 cm), we believe that PoRSHA, unlike synthetic permanent mesh, can function dynamically along with the continuously moving diaphragm.

To rigorously study PoRSHA, we have used the IDEAL implementation framework. Although no standard regulations exist for surgical innovations, the IDEAL framework provides guidance to successfully and safely evaluate a surgical innovation through a series of phases. After reporting on our first cases with PoRSHA (phase 1), we continued with the developmental phase of our innovation reported here (phase 2a). This early experience using rigorous, objective criteria provides significant optimism for the use of PoRSHA in complex, large, and long-standing hiatal defects. Our serial modifications to PoRSHA during this IDEAL phase has resulted in achieving stability of the technique (Supplemental Table 1, Supplemental Digital Content 1, https://links.lww.com/SLA/F20). In fact, after achieving consensus about how to standardize the technique among members of the MIS service, we have been able to implement this technique in another surgeon’s practice. While the technique does incur additional operative time, the use of CPT 15734 has resulted in a reimbursable effort. We found there was very little deviation from our standard foregut pathways or recovery for these patients. In fact, the only side effect potentially secondary to PoRSHA in this study was self-limited ecchymosis at the donor site.

In particularly challenging cases, we have found that PoRSHA can be easily incorporated with other advanced foregut techniques. Relaxing incisions were the most useful technique to add with PoRSHA. While the role of relaxing incisions is debatable, we find that when using the large fascial harvest, relaxing incisions can be easily performed and reinforced with the fascial flap. We found that the use of robotics for this technique seems to obviate the concern for short esophagus with large PEH. The extended length and articulating instruments on the robotic platform allowed for considerable cephalad mediastinal dissection and generous esophageal mobilization. In addition, techniques such as Collis gastroplasty, fundoplasty, gastric bypass, or gastropexy can be easily performed with PoRSHA, as demonstrated in our case series.

Lastly, while many other groups have used the falciform ligament to buttress the hiatus,18,19 PoRSHA is significantly different from the technique of falciform ligament buttress. PoRSHA technique does not use the falciform ligament for augmenting the repair but uses the thick and highly vascular posterior rectus sheath fascia to augment the repair. PoRSHA uses plastic and reconstructive techniques to recreate the diseased and damaged hiatal structure.

Limitations

This is an interim report, and long-term durability (ie, at 5 years) remains to be established. In addition, this is a limited series; wider application of the procedure studying long-term safety, complications and durability is needed. Furthermore, this series is with selection bias. Although size and type of hernia were used as inclusion criteria and PoRSHA was offered in severely attenuated defects or older patients, the surgeon ultimately decided when to use this technique. The extent to which this approach is superior to others will require a randomized controlled trial with rigorous direct comparisons to standard techniques. Finally, justifying the added time and cost relative to decreased recurrences with improved quality of eating, swallowing, and reflux symptoms will need to be appreciated.

Future Directions

By completing IDEAL Phase 2a, we have now standardized the technique for future studies and hope that by reporting our technical modifications, we will reduce the risk of other surgeons repeating unsuccessful modifications. PoRSHA will be further evaluated through a prospective multicentered registry (Phase 2b) to explore outcomes longitudinally. We encourage surgeons hoping to implement PoRSHA to receive training with proctoring of the standardized technique developed here and contribute to the prospective registry to monitor safety and outcomes. Once learning curves have been surpassed, a randomized control trial can provide us with a clear role for PoRSHA.

CONCLUSIONS

Operative standardization of the PoRSHA technique through iterative modifications is feasible. This Phase 2a report provides the benefit of our lessons learned from our early experience with PoRSHA and will offer insight to other surgeons hoping to adopt this technique. Early experience indicates that PoRSHA is safe and has a 0% short-term recurrence rate in this series. Issues of safety, cost, long-term durability and superiority over other techniques remains to be established.

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