Many surgeons say that the laparoscopic approach to ventral hernia repair has revolutionized the procedure. The minimally invasive route offers patients better outcomes with less post-operative pain and an accelerated recovery. It can even reduce a patient's risk of suffering a common complication that could return him to the surgical table in the years ahead, a complication that might actually have landed him there to begin with.
'A disease caused by surgeons'
A ventral hernia (also known as an incisional hernia) is oftentimes the direct result of a previous surgical intervention. "Hernias are holes," says Paul Curcillo II, MD, FACS, director of minimally invasive surgical initiatives and development at the Fox Chase Cancer Center in Philadelphia. "But incisional hernias are a disease caused by surgeons."
In ventral hernias, the weakness at the anterior abdominal wall that becomes a defect, letting organs protrude, is in many cases an incompletely healed surgical wound. A median incision made through the abdominal wall — for exploratory surgery, an intestinal case, vascular access, appendix removal or any open procedure — may have weakened the muscle there, particularly if a post-op infection (a common concern following abdominal surgeries) has retarded adequate healing at the site. The herniation usually appears exactly where the incision was made.
"About 20% of the patients who have open laparotomies eventually wind up with ventral hernias," notes Robert Baxt, MD, a Reistertown, Md.-based general surgeon who specializes in hernia repair and abdominal wall reconstruction. From an outcomes standpoint, 1 in 5 patients eventually needing surgery to repair an injury stemming from an earlier surgery isn't particularly auspicious. But that's not all, he says. "Historically, at 10 years after ventral hernia repair, the failure rate has been as high as 50%."
At issue was the way it was repaired. In the past, open surgery for treating ventral hernia predominated because it was the only method available. Treating an injury caused by a poorly healed abdominal incision by cutting into the abdomen again and sewing the tissue together worked about as well as you'd expect, says Dr. Baxt. Which is to say, it succeeded in some patients and eventually failed in many others.
There were several reasons for the high failure rate among open ventral hernia repairs, he says. For instance, the simple physics of the strain on an abdominal defect closed with a tension suture. "We were trying to close with too much tension and too much pull," he says. "When the patient is asleep and paralyzed, we can pull the muscles together and close a huge hole. But when they're awake, muscle contractions are powerful." Also, the procedure failed to factor in potential changes to the body, such as the added intra-abdominal pressure that would burden a repair if the patient should gain weight. Plus, later research would reveal various ways that defects in collagen connective tissue could contribute to weakening at the site. In the end, failure meant recurrence and re-operation.
When more than a few hernia specialists began to look critically at their long-term outcomes, Dr. Baxt recalls, "we came to the conclusion that obviously we were doing something wrong." Studies were conducted. An alternative was identified that would reduce tension while compressing and reinforcing the abdominal wall with prosthetic mesh, and it would do it without re-incising the weakened tissue.
Victory lap
A laparoscopic approach to ventral hernia repair, plus a rethinking of mesh placement, radically improved outcomes, say experts in the field. "It's the best way to fix a hernia, period," says Dr. Curcillo.
The minimally invasive fix gains access to the surgical site by way of small incisions made to the side of the abdominal wall defect, instead of cutting directly over it, and a mesh patch reinforces the tissue without the tension associated with earlier open procedures. And the placement of the prosthetic mesh beneath the abdominal wall, bridging the defect from inside, has been shown to deliver better results and fewer recurrences, says Dr. Curcillo. In comparison, an inlaid patch cut to fit and sewn into the defect tends to relocate but not eliminate the tension of a repair, and mesh overlaid above the defect can see a hernia re-injured under the stress exerted by a patient bearing down or even just coughing. "We do the work from inside, without an open wound," says Dr. Curcillo. "Advances in laparoscopy have allowed us to say we can fix a hernia from underneath."
Some clinical debate still exists as to whether the defect should be sewn closed in addition to the reinforcement offered by the mesh sutured, stapled or tacked to the abdominal wall. "In smaller defects, it may not matter," says Dr. Baxt, "but the larger ones really should be closed. The conservative philosophy is that just bridging is not natural, and since mesh won't contract like muscle, closing provides a better physiological repair and restored function." Abdominal and back muscles work together to keep the torso straight, he points out. If the abdomen can't counterbalance the back the way it once did, the patient will end up with back pain.
"I'm closing as many as I can," says David Renton, MD, MPH, assistant professor of surgery at Ohio State University in Columbus. "We're trying to prove that closing does reduce recurrence rates."
While the general surgery community and its subspecialty of hernia surgeons are still collecting outcomes data and awaiting a clinical judgment from 10 years out, the results so far are looking promising, says Dr. Baxt. The procedure sees a lower incidence of wound infections (which can inhibit healing), and its smaller incisions mean less post-op pain for patients and a quicker recovery than open repairs. "They're back to normal activities in only 3 days," says Dr. Baxt, although he notes that they should refrain from heavy lifting for about 3 weeks. Plus, the fix is more resilient than it was in the past, with both Dr. Baxt and Dr. Curcillo estimating that the laparoscopic technique and underlaid mesh placement have brought the failure and recurrence rate of ventral hernia repair to 10% or lower.
"Twenty years ago, patients may have had to undergo a repair 4 or 5 times over 10 to 15 years," says Dr. Curcillo. With laparoscopy and mesh, "we're not re-operating on these patients for recurring hernias." Avoiding re-operation is key, say physicians. In a study published earlier this year, researchers at the University of Alabama at Birmingham who'd re-viewed the cases of 1,444 patients who'd undergone incisional hernia repair at 16 Veterans Affairs medical centers over the course of 4 years made the case that employing techniques that reduced the risk of recurrence was even more important than the type of mesh used or the position in which it was placed.
What it takes
If incisional hernias aren't being repaired laparoscopically in every outpatient OR nationwide, it's due simply to a lack of experienced hands. "The only thing that its prevalence depends on is whether people can do it," says Dr. Renton. Experts say the procedure is more demanding in terms of the technical skill required than its open analogue. "Laparoscopy is done upside-down and backwards," says Dr. Curcillo. "You come in from below." But, says Dr. Renton, "anyone who's done a laparoscopy fellowship should be able to do it." Physicians can take training courses on the technique, or physician practices can hire a younger partner adept in the skills. Dr. Baxt estimates that efficient laparoscopic hernia repair takes about 50 cases to master.
The instrumentation needed to undertake laparoscopic hernia repair is the same standard equipment employed by colorectal, gynecological and other lap specialties: trocars for access, scopes for visualization, tools that substitute for hands and staple or tack guns to secure the mesh to the abdominal wall.
Dr. Renton, however, says he has been impressed by more recently introduced instruments developed specifically for the task of deploying, positioning and holding the mesh patch inside the abdominal wall, without additional trocar sites and tools. "It takes the guesswork out of it," he says. While he admits he doesn't use such devices himself, he sees its value in assisting technique. "It facilitates a lower learning curve for surgeons who haven't routinely done laparoscopic hernia repair."
A WELL-REIMBURSED, HIGH-VOLUME PROCEDURE | ||||
It Pays to Perform Laparoscopic Hernia Repair The laparoscopic repair of incisional hernia "is a huge niche for outpatient surgery," says Robert Baxt, MD, a Reistertown, Md.-based general surgeon who specializes in hernia repair and abdominal wall reconstruction. "It's a general anesthesia case, done in an hour or an hour and a half, with a few hours of recovery. There are a lot of cases out there to do. And the reimbursement numbers are decent." While the numbers took a slight dip for calendar year 2011, laparoscopic hernia repair surgeries — added to the Centers for Medicare and Medicaid Services' ASC procedure list in 2009 — have been rising, as you can see in the table below, outlining the national ASC payment rate for laparoscopic hernia repair. — David Bernard | ||||
2009 |
2010 |
2011 |
2012 (proposed) |
|
49652: Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); reducible |
$1,529.28 |
$2,919.34 |
$2,754.57 |
$2,818.71 |
49653: Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); incarcerated or strangulated |
$1,529.28 |
$2,919.34 |
$2,754.57 |
$2,818.71 |
49654: Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed); reducible |
$1,529.28 |
$2,919.34 |
$2,754.57 |
$2,818.71 |
49655: Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed); incarcerated or strangulated |
$1,529.28 |
$2,919.34 |
$2,754.57 |
$2,818.71 |
49656: Laparoscopy, surgical, repair, recurrent incisional hernia (includes mesh insertion, when performed); reducible |
$1,529.28 |
$2,919.34 |
$2,754.57 |
$2,818.71 |
49657: Laparoscopy, surgical, repair, recurrent incisional hernia (includes mesh insertion, when performed); incarcerated or strangulated |
$1,529.28 |
$2,919.34 |
$2,754.57 |
$2,818.71 |
Advances in the fixation devices that secure mesh while the tissue grows around and into it have also lent improvements to the procedure and its outcomes, he says. The devices are available in shapes ranging from staples to tacks to screws, and in permanent and absorbable options. One recent product, a lower profile, deeper holding, absorbable staple, appears to be a worthwhile innovation, he says.
Among surgeons, the choice of mesh is an issue of constant debate. There are many brands and weights of non-absorbable synthetic meshes, which ideally should become incorporated into the abdominal wall tissue it is reinforcing, but not into the bowels, in which it may cause adhesions, intestinal obstructions or fistulas. "The difficulty is, you're working between these two areas," says Dr. Curcillo. "You want it to do one thing on one side, and another thing on the other." To facilitate this goal, some meshes are coated with cellulose, omega-3 fatty acid gel or titanium to prevent adhesions on the bowel side.
As a foreign substance, a synthetic mesh also runs the risk of causing inflammation after it is implanted. This risk is lessened with biological mesh, a graft of human or porcine skin, which will bind with, heal into and be absorbed by the surrounding tissue. It's a far more expensive option than synthetic mesh, but for an infected or contaminated surgical site, this is a safer option that's more likely to be accepted by the body. After the infection clears, the biological mesh can be replaced or supplemented by a synthetic mesh.
The choice of mesh depends on the demands of a particular case, the condition of the patient and the option that the surgeon is most comfortable with. To administrators, though, the most important factors to keep in mind are a mesh's price and its rates of infection and failure, which together can provide a cost-benefit analysis, says Dr. Curcillo.
The manufacturer's rep will provide you with the price, he says, and a mesh patch can range from $200 to $5,000 depending on whether it is synthetic or biological; a small sheet or a large one; and lightweight, midweight or heavyweight. For the infection and failure rates, consult published clinical studies instead of the rep. "Then ask, if one mesh costs more than another, what's the benefit?" says Dr. Curcillo. "In the long term, I'd pay a little extra if I knew the recurrence rate or infection rate was lower." This cost-benefit thinking, as well as comparing similarities and identifying uniquenesses between products, can also help to standardize your mesh inventory.
Make your physicians aware of the cost of the mesh they're implanting in conjunction with whether your facility is being reimbursed for the supply. "Doc-tors think that any time they use something in the OR, the center is being reimbursed," says Dr. Curcillo. "If you put a $3,000 mesh in and it's not reimbursed, was that cost justified? If something else does just as well, why spend the extra money?"
A surgical procedure that not only fixes complications stemming from earlier surgical procedures, but does so reliably enough to render the re-operations of previous surgical options unnecessary holds a lot of promise for patients.