Dr Hornbostel, tell me about your professional journey from general surgeon to an exclusively bariatric practice.
I finished general surgery residency in 1984 and immediately went into private practice in a rural area of MO. This involved the typical "bread and butter" of general surgery in that era, including some peripheral vascular, pacemakers, carpal tunnel releases, etc., and I realized about 3-4 years out from residency that the infrequency of some of these procedures was making it too challenging to maintain currency, and began dropping the rare and complex stuff. But the summer of 1990 was the "rude awakening" for general surgeons across America. The coming of laparoscopic cholecystectomy mandated one of two choices for general surgeons: 1) learn laparoscopy or 2) retire. Of the four surgeons in my facility, three retired, within 18 months of one another. This left me the sole general surgeon for about 40,000 patients. I obviously had to trim back dramatically, but at the same time I learned that I really loved laparoscopy and tried to apply it as frequently as possible. By 1993, laparoscopic appendectomy and laparoscopic adhesiolysis for SBO were so natural to me that I was able to avoid laparotomy for these patients more than 95% of the time. By 2000, I had successfully completed about 4000 laparoscopies for everything from chole to colon. I had read Wittgrove and Clark's monograph on lap gastric bypass back in 1995 with curiosity, but in the "methods" section, they were describing an operative time of 6-8 hours per patient, which was simply not feasible for the community surgeon, so I forgot about it. I had had personnel in the hospital, who had morbid obesity, approach me at times over the years asking whether I would consider bariatric surgery, and, with memories of horror stories during residency (Truman Medical Center, K.C., in the 1980's, "dabbled" in bariatrics, with little efficacy and a perioperative mortality in excess of 10%!), politely declined. Fast forward then to Southwest Surgical Congress meeting in April, 2001, in Cancun. Dan Jones was presenting the data from UT/Southwestern in Dallas on lap gastric bypass, including operative times less than 120 minutes. At his conclusion, he advised the surgeons of the audience that there was fertile ground for the laparoscopic surgeon who enjoyed challenges. I talked with him after that presentation, and he kindly invited me to come to Dallas to learn the procedure. I took my partner at the time and two private scrub nurses, and we spent nine days in relatively intensive didactics, including animate lab, cadaver lab, simulators, OR observation and at the conclusion, he said "You know, Phil, you can do this". I took a couple more "hands-on" courses over the ensuing six months, and then launched carefully in Feb. of 2002. We started with hand-selected patients who knew our meagre experience with the procedure, and I'm proud to say that with careful selection, we proceeded with no mortalities and a conversion rate less than 3% in our first two years. At that point, I had to revise the technique, as we learned that my partner was not being reimbursed at all for his presence as first assistant, the vast majority of cases. And from there, it became virtually "my" bariatric program, as he quickly stepped aside to resume full-time general surgery. By 2008, I had provided over 600 patients with care, and at that time, had to drop my general surgery practice, which, of course, eliminated the possibility of staying at my rural hospital, due to on-call constraints with general surgery as a part of credentialling. I've been full-time bariatric surgeon at my current facility for 23 months now.
Why do we need "Centers of Excellence"? Why are post-training fellowships in bariatrics deemed essential?
"Centers of Excellence" (COM) was a concept conceived by Harvey Sugarman and Walt Pories by 2000, but failed to get traction until the fall of 2005. At that time, a secretary surfing the net, ran across a "public comments invitation" from CMS, prior to elimination of coverage for any bariatric surgery (!!!). She asked Dr. Sugarman if this was important, and, well, needless to say, the ASBS (at the time, now ASMBS---American Society for Metabolic and Bariatric Surgery) leapt in high gear. Dr. Sugarman learned that the ONLY physician on the review panel for CMS at that time was a retired ophthalmologist. He called the ophthalmologist and asked "Would you be willing to look at some published data?" Well, what could he say? "Sure". The tale from ASBS is that Dr. Sugarman had two hand-trucks worth of articles delivered to the ophthalmologist, and that he called Dr. Sugarman the following week and said simply "I had no idea". The final deal hammered out was that CMS would cover the approved procedures (at that time gastric bypass, BPD/DS, and VBG) only at facilities designated by ASBS as "Centers of Excellence for Bariatric Surgery".
You mean that bariatrics almost never got off the ground?
Indeed, it was the apparent intent of CMS (Centers of Medicaid and Medicare Services) to eliminate, on a permanent basis, ALL coverage for bariatric surgery, based on the (mistaken) assumption that there was no evidence of efficacy for ANY interventions for obesity (medical or surgical). And indeed, at least as related by Dr. Sugarman and others to the ASMBS) membership, it was only a serendipitous afternoon of "web surfing" under "bariatric surgery" that led the secretary in the ASBS office to uncover this information. Whenever CMS plans to change coverage in what would be considered a "significant form" in any aspect of health care delivery, they are required by federal regulation to solicit comments from the public during a "public comments" interval (I think these are designated at something like 60 days), and 45 days after that interval closes, CMS announces its final determination, based on CMS research as well as public comments. By all indications, this was a very "near miss", that potentially could have eliminated bariatric surgery as we know it. In the meantime, Harvey and Walt had asked, early on, whether ACS would be interested in the concept, and ACS politely but firmly advised them to look elsewhere. But now, at the eleventh hour of a unique exclusive coverage issue unprecedented by CMS, the ACS came calling. And Harvey and Walt plainly and firmly told them to go back to Chicago (if not elsewhere!). So, rather than suffer outright rejection, ACS decided to take on the project themselves, thus creating two independent parallel systems, with differing details, but both acceptable to CMS. On February 22, 2006, a date every bariatric surgeon from that era can recite, the "hammer fell". All CMS patients scheduled for bariatric surgery at facilities NOT "COE", were cancelled on the spot. There was now a rapid progression of applications and inspections and neither ASBS (through a separate inspection corporation, the "Surgical Review Corporation" (SRC)) nor ACS was able to keep pace. We were the second designated COE in MO, on April 2, 2006, and were immediately inundated with patients (we were well ahead of the University of MO, and slightly ahead of Barnes Hospital/Washington University/St. Louis). At any rate, the membership of the now-ASMBS, in 2009, petitioned for unification of the two groups, ACS and SRC, and this was aggressively pursued by the leadership. By 2011, the steps were ironed out, and then, again at the eleventh hour, the SRC leadership, independent of the ASMBS, balked, pulled away, and created a "rogue corporation", which ASMBS has disavowed. Currently, most COE programs are now under the auspices of ACS, and, at this writing, are awaiting the guidelines of the new merged organization. But preliminary draft indicates a significant "watering down" of the concept in its various requirements. It is too early to know the impact. Outcomes data for bariatrics typically trails the aggression of the surgeons, the procedures, and the patients, by about five years. Wait and see.
As to fellowships, well, the way I came to bariatrics can no longer be done. The shift from open to laparoscopic bariatric surgery was a watershed event: patients came out of the woodwork, and there were few surgeons who successfully transitioned from open bariatrics to laparoscopic bariatrics (due, in no small part, to a general lack of experience with laparoscopy generally). As a result, with a burgeoning patient demand and a dearth of surgeons, the ASBS send out apostles like Dan Jones to solicit input from experienced LAPAROSCOPIC surgeons to take up the slack and to take up the cause. Although I found this highly successful and rewarding, I was apparently in a clear minority (I've since proctored five surgeons who had taken my pathway and were pursuing credentialling in bariatrics--NONE of them ended up successfully). By 2005, it was clear that the only successful pathway into bariatrics was going to be through dedicated fellowships. Why? Several factors: unique complications from an extremely complex (by laparoscopic standards) operation, that require careful clinical followup and RAPID interventions (internal hernia continues to be a fatal complication in at least two dozen patients per year across the US, due in large part to delay in diagnosis and intervention), a relatively challenging set of laparoscopic skills beyond that taught in surgical residency (due to some degree by lack of teaching excellence in laparoscopy by senior staff surgeons), and concerns from the hospital/facility side regarding liability exposure with some of these more spectacular complications, and concerns with the legal theory of "negligent credentialling": allowing surgeons with meagre experience the privileges of laparoscopic bariatrics. Finally, as you are already aware, specialization is the "way of the world" in the 21st century: yet another "carve-out" from general surgery due to volume concerns
What are your thoughts on the various surgical options for weight loss surgery? Have a preference? Is one better than all the rest?
Optimal procedures? Well, the bypass remains the American standard since Ed Mason first presented it over 40 years ago now. It has been through many challenges and modifications over the years, but the standard remains remarkably the same. The limbs are longer now (the "Cohen" standard for bypass in diabetics is a biliopancreatic limb 100cm below the ligament of Treitz, and an alimentary limb of 150cm), but the concept of bypassing the duodenopancreatic axis is apparently a dramatic producer of both anorexia and intolerance to processed carbs. Not a panacea (the typically quoted "long-term" success for this procedure in maintaining excess weight loss of over 50% for more than 5 years is 60-70%), but all others have to be measured against this approach. So, the sleeve, which is becoming more popular by the week: may be a good solution, but patients must always be advised beforehand that a) it is NOT reversible, so if we decide 10 years from now that this wasn't such a great idea, those patients are screwed, b) we have no good 10-year track record for the procedure, so we simply don't know where we'll stand in 10 years, and c) the procedure, purely and simply, induces reflux esophagitis, so if that's a major comorbidity for a given patient with morbid obesity, sleeve may not be a good option. It has true cachet with the surgeons simply because it is, at face value, a simpler procedure to construct. But we are learning that this doesn't mean it is a simple procedure: torquing of the sleeve, stricture at the incisura, and delayed blowout of the cardia are all now well-described, and nightmares for the patient and the surgeon. The band is finding its "niche" in the US, but the niche, like the general surgery niche, grows smaller every day. The band is not nonsense, but the corporations who brought it to the US behaved in such a reprehensible way in over-marketing to the public, that they deserve all the recriminations coming their way. Currently, the band may be a good option in 1) adolescents up to age 25, where metabolism is still on their side, and curbing binge eating may be a major benefit in weight control, 2) those who have a troublesome 50lb to lose that they simply cannot eliminate by diet/activity (this is the "new" indication with BMI 30-35), and 3) the suburban housewife in much the same circumstance, who weighs about 40lb more than everyone else in her golf foursome, bridge foursome or playgroup, and knows, knows that whenever she's absent, her weight is the topic of conversation. But we have publications now, starting from the deMaria report during the Phase I trials of the lapband in the US, that say band is a bad idea in African-American women with BMI over 40, patients over age 60 (Provost, who 2 years previously had hypothesized that that might be an ideal group!), and patients with BMI > 46. Then, in 2009, the surgeons who developed the band in Europe, for the first time, removed more bands than they put in, and ditto the Australian surgeons, who sold it to the US, in 2011. I was warned by European surgeons coming to the MISS, back in 2007, and gladly abandoned it to the programs surrounding me in MO. And now have looked prescient. The other procedure that deserves mention, because it appears to be making a comeback, is the duodenal switch/biliopancreatic diversion (DS/BPD). This procedure is assuredly the most potent current operation for weight loss, but carries significant malabsorption risks and patients must be followed closely. Further, it carries the highest perioperative morbidity and mortality, and both are statistically significant. Personally, I don't offer this procedure in my program, but I do advise any patient I operate who has a beginning weight over 500lb, that their best bet is not bypass, but rather DS/BPD.
Comment if you will on obesity in America? Why has it become such a prominent health risk? Is it symptomatic of fundmental pathology, food production issues, poverty, wealth inequality?
Obesity in America is a difficult, complicated issue. The underlying source, in the main, is of course over-consumption of processed carbs (not dietary fats, despite 40 years of bad information from dietitians). But this is further complicated by a society that financially penalizes more healthful food choices, encourages sedentary motorized transportation (many suburbs from the '40's to today have no sidewalks!), provides processed carbohydrates at fast-food windows 24 hours/day so you need not leave your sedentary motorized transportation, discourages physical education in schools, while making the school day ever shorter, encourages school snacks in some cases up to four times in a 6-7 hour school day, discourages home food preparation, and provides little opportunity for activity outside of employment. Physicians further this problem by lack of nutritional/obesity education, and advise patients with BMI>50 that "you just need to eat less and exercise", which is the equivalent to telling a patient with stage II colon cancer "you just need to cut out barbecued red meats and eat more fiber". Physicians have, all too often, refused to acknowledge that these patient have an acquired illness, that, regardless of etiology, warrants aggressive treatment, and that the only proven treatment available in 2013 for patients with BMI>40 is bariatric surgery (NIH monograph, 1991).
Who should have bariatric surgery? What are your personal criteria?
So, who should have surgery? In my program, patients with BMI greater than 35 who are at least 18 years of age, will get consideration. If they have few or no comorbidities, and a BMI less than 40, I will encourage them to consider a dietary effort under careful appropriate supervision, but will not turn them away. Due to consent constraints, I am not currently authorized to offer bariatric surgical interventions to patients younger than 18 years of age. I have no upper age limit, and have successfully bypassed 3 patients at age 78. But above age 70, I "pick my battles" and reject patients with overwhelming cardiovascular and/or pulmonary issues. The "grey area" currently is that of patients with BMI 30-35 who have type II diabetes mellitus. If one of these patients can arrange financially for the procedure, I'd likely proceed. But, at the same time, the outcomes being currently reported from Rio, on patients with BMI 25-35 having bypass to address type II DM, is not nearly as encouraging as it is in the morbidly obese. They theorize a more "robust" manifestation of type II DM in "normal sized" patients, that does not require obesity to develop. I'd sure disclose that concern to smaller patients seeking bypass for diabetes treatment.
What are long term expectations in terms of weight loss, co-morbidity resolution, change in eating habits?
As to my expectations in terms of weight loss, I seek a long-term loss of 50% of excess weight, maintained at five years. I get this perhaps 65% of the time with my bypass patients, but perhaps only 25% of the time in the band patients I still follow (about 60 of these currently). Sleeve patient outcomes in my practice fall somewhere in the middle, much better than bands, but only rarely as effective as bypass. All of my patients, regardless of procedure, are encouraged to follow something of a "paleo" diet, and to focus on protein sources (at least 60gm/day), green vegetables, and fruit as tolerated. And of course are always encouraged to "slow down". I'd like to see greater than 80% resolution or very dramatic improvement in diabetes in my bypass patients, and also appreciate about a 50% resolution of dyslipidemia. Hypertension also seems to resolve in the long run in the majority of my patients, although a small but real cadre continues to take a single antihypertensive, usually a beta-blocker or ACEI. Obstructive sleep apnea is a more problematic issue, apparently due in part to chronic over-stretching of the matrix of the posterior oropharynx, and thus often fails to resolve. I think we may witness a renaissance of the UPPP procedure from our ENT colleagues, following patient weight loss, to try to resolve the issue permanently. We'll see. Parenthetically, I've now had five patients resolve their IIH (formerly "pseudotumor cerebri"), and now have two neurologists and the neurosurgery group actively directing appropriate patients into our program.
How has the safety profile in bariatrics chnaged over the past 15 years, for better or worse?
The safety profile of all bariatric surgery has changed dramatically in the past 15 years. Published report in NEJM in the summer of 2009 demonstrated equivalent risk of M/M with bariatrics and with total joint replacement and laparoscopic cholecystectomy (I can track that reference if you'd like). I attribute this to several factors: the emphasis on fellowship training, the emphasis on outcomes tracking, and, in large part, the incredible advances in imaging in the past seven years. I cannot overstate that final point; when compared with the old "three chip cameras" of the early 1990s, the high-def imaging of today pretty much puts advanced laparoscopic surgeons under the microscope. And the resultant tissue manipulation is becoming almost artwork now.
Patient who have had bariatric procedures done develop unique long term complications (internal hernias, difficult to diagnose bowel obstructions, etc). Where are these patients best served? Ought they all to be airlifted to centers with bariatric specialists when they show up in random ER's?
As to addressing the bariatric surgery patient with abdominal symptoms, I think that at the very least, a bariatric surgeon needs to be called before allowing a patient with that presentation to leave the ER. We still likely lose over 20 patients/year to internal hernias, and they are not easy to diagnose. They present with normal lab more than 70% of the time, and with normal imaging at least 50% of the time, and often, after several bouts of self-limited abdominal pain, become labelled incorrectly as "drug seekers". I've had patients return to MO to see me from Louisville, KY, Dayton, OH, and Syracuse, NY, after being evaluated by multiple general surgeons who missed this critical diagnosis. But to me, theworst treatment of patients occurs when patients with abdominal symptoms and a history of bariatric surgery, present to a tertiary center that provides bariatric surgery; and the bariatric surgeon is not called!! I've seen this on at least two occasions, and both times the patient ended up with a major resection that could have, and should have, been avoided.
Talk about the technical aspects of bariatrics in terms of long term complications.
As to biggest technical hurdle, well, I've never seen much bleeding problems, at least not to warrant return to the OR. I think stricturing of the gastric outlet in bypass can be a real aggravation. I do my own endoscopies, so I've become facile in sorting this out; I truly pity the bariatric surgeon who, due to inexperience, or worse, to political constraints, cannot do his/her own endoscopy. It really puts the patient in the hands of physicians who don't understand the nuances of what we are trying to accomplish. I've devised a laparoscopic solution to stricturing that I'm not currently at liberty to discuss, as it's in press. I have yet to have a sleeve leak; but I've been assured repeatedly that this is but a matter of time, and that my time is coming. Currently, a very small, but very demanding group, is the patient after bypass with excessive weight loss, who struggles to maintain a BMI of 19. I've reversed two of these so far, and currently am following a half-dozen others with feeding tubes in the remnant stomach, who are trying to avoid reversal.