Friday, September 15, 2017

PCOS and Endometrial Cancer Risk: The Dilemma of Weight Loss and Weight Cycling


September is Polycystic Ovarian Syndrome (PCOS) Awareness Month. As part of our ongoing series on PCOS, today we are going to talk about endometrial cancer.

PCOS is a hormonal disorder usually characterized by very strong insulin resistance. This insulin resistance causes many problems in the body, including irregular menstrual cycles, strong susceptibility towards weight gain, unwanted hair growth on the face and body (hirsutism), hair loss on the head (alopecia), cystic acne, body tags, a strong tendency towards diabetes, infertility, and many other symptoms.

Among other risks, PCOS is associated with a high risk for endometrial cancer (cancer in the lining of the uterus). Because PCOS tends to cause an irregular menstrual cycle, a woman's uterine lining may not get sloughed off each month. Some women with PCOS have extra long cycles (35 or more days), while others go months or even years without a menstrual cycle. This causes the lining of the uterus (the endometrium) to build up excessively; in time, atypical cells may develop. This is called endometrial hyperplasia, or overgrowth of the uterine lining. This hyperplasia can eventually turn into endometrial cancer.

This is why it is so important that women with PCOS get treatment. They need to have regular periods so that this overgrowth does not occur. There are many options for this, including progesterone treatmentsbirth control pills; insulin sensitizers like metformin, TZDs, or inositols; and androgen blockers.

However, most doctors' first recommendation is weight loss.

The Weight Loss Dilemma

The majority of women with PCOS have an "overweight" or "obese" BMI. Because of the very significant insulin resistance with PCOS, these women have a strong tendency towards weight gain over time.

Women of size with PCOS face a difficult dilemma in how they approach their weight. Care providers push them to lose weight, often telling them weight loss can "cure" PCOS or get rid of most of their symptoms. Weight loss is considered by many to be the first line of therapy for PCOS.

It's true that some short-term research does seem to suggest benefits from weight loss for women with PCOS, especially in shocking the system into ovulation. But this research is almost always based on fairly short follow-ups because most weight comes back within a few years after a significant weight loss. The very loss that leads to short-term benefits may backfire later into weight gain and worsened insulin resistance.

The critical question is whether women are better off in the long term trying to lose weight, or whether the high potential for weight cycling overcomes the possible benefit of weight loss. In particular, we need to know how weight loss and weight cycling affects the chances of getting endometrial cancer.

Here are two studies that demonstrate this weight loss dilemma. One study (Luo 2017) looked at intentional weight loss in "obese" women and how that affected their risk for endometrial cancer. (The study did not look specifically at women with PCOS but weight and PCOS are so tightly tied together that weight is a pretty fair proxy for presumed PCOS when discussing endometrial cancer.)

In the study, those women who intentionally lost weight lowered their chances for endometrial cancer. The effect was particularly strong in obese women who intentionally lost weight. So if  you can lose weight and keep it off, it looks like there might be some benefit.

However, remember that the majority of women who lose weight gain it back, and often end up at a higher weight than they started. In the Luo study, women who gained weight were at increased risk for endometrial cancer. So you take a calculated risk; if you lose weight and keep it off, you might significantly reduce your risk for endometrial cancer. However, if you regain that weight and end up heavier than you started, you probably have increased your risk for endometrial cancer.

Weight fluctuations up and down the scale may also have its own independent effect. The second study (Welti 2017) found that weight cycling 4-6 times was associated with an increase in risk for endometrial cancer. Many women of size cycle far more times than that; how increased is their risk?

Summary

High BMI women with PCOS face a difficult dilemma when deciding what to do to lessen their risk for endometrial cancer.

Intentional weight loss ─ if they can keep it off ─ might lower their risk for endometrial cancer. On the other hand, if the weight loss attempt leads to weight cycling and/or overall weight gain ─ as it does for so many ─ then that weight loss attempt probably actually increases their risk. 

In other words, high BMI women with PCOS are faced with a game of Russian Roulette when it comes to weight loss and endometrial cancer.  

There are no easy answers here. Each individual woman gets to make her own choices about weight loss as a treatment for PCOS, taking into account her own personal weight history and habits.

Although most doctors don't acknowledge it, it is a perfectly reasonable choice not to pursue weight loss as a treatment for PCOS. That doesn't mean that lifestyle is irrelevant. One can choose to emphasize sensible nutrition and exercise as a treatment for PCOS without measuring the worth of those treatments by weight loss. A Health At Every Size® approach can work for PCOS.

Care providers need to recognize that their constant pressure on patients to lose weight may actually backfire and create more risk rather than less. They need to recognize the right of the patient to choose whether or not to pursue weight loss, that it is possible to emphasize healthy lifestyle without tying that to weight loss, and to acknowledge the need for multiple tools beyond weight loss to address the unique needs of their PCOS patients.



References

Cancer Epidemiol Biomarkers Prev. 2017 May;26(5):779-786. doi: 10.1158/1055-9965.EPI-16-0611. Epub 2017 Jan 9. Weight Fluctuation and Cancer Risk in Postmenopausal Women: The Women's Health Initiative. Welti LM, Beavers DP, Caan BJ, Sangi-Haghpeykar H, Vitolins MZ, Beavers KM. PMID: 28069684
BACKGROUND: Weight cycling, defined by an intentional weight loss and subsequent regain, commonly occurs in overweight and obese women and is associated with some negative health outcomes. We examined the role of various weight-change patterns during early to mid-adulthood and associated risk of highly prevalent, obesity-related cancers (breast, endometrial, and colorectal) in postmenopausal women. METHODS: A total of 80,943 postmenopausal women (age, 63.4 ± 7.4 years) in the Women's Health Initiative Observational Study were categorized by self-reported weight change (weight stable; weight gain; lost weight; weight cycled [1-3, 4-6, 7-10, >10 times]) during early to mid-adulthood (18-50 years). Three site-specific associations were investigated using Cox proportional hazard models [age, race/ethnicity, income, education, smoking, alcohol, physical activity, hormone therapy, diet, and body mass index (BMI)]. RESULTS: A total of 7,464 (breast = 5,564; endometrial = 788; and colorectal = 1,290) incident cancer cases were identified between September 1994 and August 2014. Compared with weight stability, weight gain was significantly associated with risk of breast cancer [hazard ratio (HR), 1.11; 1.03-1.20] after adjustment for BMI. Similarly, weight cycling was significantly associated with risk of endometrial cancer (HR = 1.23; 1.01-1.49). Weight cycling "4 to 6 times" was most consistently associated with cancer risk, showing a 38% increased risk for endometrial cancer [95% confidence interval (CI), 1.08-1.76] compared with weight stable women.  CONCLUSIONS: Weight gain and weight cycling were positively associated with risk of breast and endometrial cancer, respectively. IMPACT: These data suggest weight cycling and weight gain increase risk of prevalent cancers in postmenopausal women. Adopting ideal body-weight maintenance practices before and after weight loss should be encouraged to reduce risk of incident breast and endometrial cancers. 
J Clin Oncol. 2017 Apr 10;35(11):1189-1193. doi: 10.1200/JCO.2016.70.5822. Epub 2017 Feb 6. Intentional Weight Loss and Endometrial Cancer Risk. Luo J, Chlebowski RT, Hendryx M, Rohan T, Wactawski-Wende J, Thomson CA, Felix AS, Chen C, Barrington W, Coday M, Stefanick M, LeBlanc E, Margolis KL. PMID: 28165909
PURPOSE: Although obesity is an established endometrial cancer risk factor, information about the influence of weight loss on endometrial cancer risk in postmenopausal women is limited. Therefore, we evaluated associations among weight change by intentionality with endometrial cancer in the Women's Health Initiative (WHI) observational study. PATIENTS AND METHODS: Postmenopausal women (N = 36,794) ages 50 to 79 years at WHI enrollment had their body weights measured and body mass indices calculated at baseline and at year 3. Weight change during that period was categorized as follows: stable (change within ± 5%), loss (change ≥ 5%), and gain (change ≥ 5%). Weight loss intentionality was assessed via self-report at year 3; change was characterized as intentional or unintentional. During the subsequent 11.4 years (mean) of follow-up, 566 incident endometrial cancer occurrences were confirmed by medical record review. Multivariable Cox proportional hazards regression models were used to evaluate relationships (hazard ratios [HRs] and 95% CIs) between weight change and endometrial cancer incidence. RESULTS: In multivariable analyses, compared with women who had stable weight (± 5%), women with weight loss had a significantly lower endometrial cancer risk (HR, 0.71; 95% CI, 0.54 to 0.95). The association was strongest among obese women with intentional weight loss (HR, 0.44; 95% CI, 0.25 to 0.78). Weight gain (≥ 10 pounds) was associated with a higher endometrial cancer risk than was stable weight, especially among women who had never used hormones. CONCLUSION: Intentional weight loss in postmenopausal women is associated with a lower endometrial cancer risk, especially among women with obesity. These findings should motivate programs for weight loss in obese postmenopausal women.

Thursday, August 31, 2017

Lower Surgical Threshold, Less Patience in Labor for "Obese" Women


Here is yet another study (Ellekjear 2017) showing that labor is often managed differently in "obese" women, with a lower surgical threshold being the most marked finding. The authors concluded:
Caesarean deliveries are undertaken earlier in obese women compared to normal weight women following the onset of active labour, shortening the total duration of active labour.
Research generally shows women of size probably need more time in labor in general, especially in the early stages, but once their labors get going, they usually go well. However, many care providers opt to terminate labor earlier and move quickly to a cesarean. They are understandably concerned about the risks of doing an emergent cesarean on a larger body, but they are usually giving up far too soon and causing an epidemic of "failure to wait" cesareans in women of size. .

There was an infamous Vaginal Birth After Cesarean (VBAC) and obesity study in 2001 that demonstrated this quite strongly. 30 women over 300 lbs. were "allowed" to labor for a VBAC, but only 13% of those who tried for a VBAC ended up with one. As a result, this was widely publicized as a reason not to "let" high-BMI women try for a VBAC and cited by doctors as a reason to deny fat women the opportunity to VBAC.

However, what the full text of the study actually reveals is that the majority of these women were induced, which is known to increase the chances of cesarean and lower the chances of VBAC. Interestingly, the only women who got a VBAC in this study were the ones who were not induced.

Most tellingly, those who had cesareans had their labors stopped at an average of 4.5 cm of dilation. 4.5 cm barely qualifies for the old definition of active labor, and certainly doesn't fit with the new recommended definition of active labor (6 cm)! In other words, these high BMI women were not given an adequate chance to labor.

High induction rates and a lack of patience in labor are the main factors that drive the high cesarean rate in obese women. 

Studies have shown that about half of high BMI women in general are induced, typically increasing cesarean rates. However, when allowed to go into spontaneous labor, cesarean rates are more equalized among BMI groups.

One earlier study found that high BMI women tended to take longer to progress in labor, especially between 4 and 7 cm of dilation. They urged far more patience in the labors of heavier patients.

Similarly, a 2016 study found that 57% of labors in high BMI first-time mothers were stopped before 6 cm of dilation; those mothers ended with cesareans. Failure to Wait is a major problem when doctors attend women of size.

More spontaneous labor and more time during labor would probably have yielded far better VBAC rates in that 2001 VBAC study. It should be pointed out that a look at some later studies showed VBAC rates around 50-70% in obese women, which could almost certainly be increased even more since they also reflect very high induction rates and the old active labor definition. Indeed, research from England shows that the majority of even very high BMI women can have a vaginal birth with different management.

The bottom line is that multiple studies have found that the labors of high BMI women are managed differently than the labors of average-sized women. 

In particular, too many inductions are being done, the surgical threshold is very low, and more patience is needed during labor. This represents an area that is ripe for change and offers hope for lowering the far-too-high cesarean rate in obese women. 

As the authors of a Canadian study concluded about the management of high BMI women:
Because of the potential morbidities associated with Caesarean section, we must modify our management approaches to allow equal opportunity for a vaginal birth for all women.

Reference

BMC Pregnancy Childbirth. 2017 Jul 12;17(1):222. doi: 10.1186/s12884-017-1413-6. Maternal obesity and its effect on labour duration in nulliparous women: a retrospective observational cohort study. Ellekjaer KL, Bergholt T, Løkkegaard E. PMID: 28701155
...METHODS: Retrospective observational cohort study of 1885 nulliparous women with a single cephalic presentation from 37 0/7 to 42 6/7 weeks of completed gestation and spontaneous or induced labour at Nordsjællands Hospital, University of Copenhagen, Denmark, in 2011 and 2012. Total duration of labour and the first and second stages of labour were compared between early-pregnancy normal-weight (BMI <25 kg/m2), overweight (BMI 25-29.9 kg/m2), and obese (BMI ≥30 kg/m2) women. Proportional hazards and multiple logistic regression models were applied. RESULTS: Early pregnancy BMI classified 1246 (66.1%) women as normal weight, 350 (18.6%) as overweight and 203 (10.8%) as obese. No difference in the duration of total or first stage of active labour was found for overweight (adjusted HR = 1.01, 95% CI 0.88-1.16) or obese (adjusted HR = 1.07, 95% CI 0.90-1.28) compared to normal weight women. Median active labour duration was 5.83 h for normal weight, 6.08 h for overweight and 5.90 h for obese women. The risk of caesarean delivery increased significantly for overweight and obese compared to normal weight women (odds ratios (OR) 1.62; 95%CI 1.18-2.22 and 1.76; 95%CI 1.20-2.58, respectively). Caesarean deliveries were performed earlier in labour in obese than normal-weight women (HR = 1.80, 95%CI 1.28-2.54). CONCLUSION: BMI had no significant effect on total duration of active labour. Risk of caesarean delivery increased with increasing BMI. Caesarean deliveries are undertaken earlier in obese women compared to normal weight women following the onset of active labour, shortening the total duration of active labour.

Sunday, August 20, 2017

Researchers' Goof: Transverse CS Incisions ARE Better in High BMI Women!


EXTRA, EXTRA! 

Researchers messed up the conclusion of earlier cesarean incision study! 

Transverse (side-to-side) incisions really are better after all for high BMI women! 

Vindication! 

Background

For many years OBs were taught that a vertical incision was needed for very "obese" women because the area under a belly flap ("panniculus", sometimes referred to as a "pannus") was hot and moist and therefore prone to infection ─ in other words, an area just waiting to cause wound complications. One OB wrote in 2006:
In general, there is a lot to be said for an incision not buried under the pannus of fat, so that fresh air can help keep the wound dry.
As a result, many OBs were taught that when they did cesareans on high BMI women, vertical (up-down) incisions should be used instead of low transverse (side-to-side, either Pfannenstiel or Joel-Cohen) incisions in order to lower the risk for infection, separations, and other wound complications.

WRONG! Example of incorrect teaching illustration
about vertical incisions and obesity
They meant well, but they were operating from flawed assumptions and outdated teaching. In other words, they hadn't actually studied whether or not vertical was better in high-BMI women, they just assumed it was, based on their biases about fat bodies. As the authors of Alanis 2010 state:
Our results...contradict classic teaching by veteran surgeons and obstetrical texts. It has been written that transverse abdominal incisions made under the pannicular fold exist in “a warm, moist, anaerobic environment associated with impaired bacteriostasis . . .[that] promotes the proliferation of numerous microorganisms, producing a veritable bacteriologic cesspool.” However, we are unable to locate any evidence to support this popular conclusion....
A "veritable bacteriologic cesspool"? What a terrible and disrespectful way for those obstetric texts to describe it. While deep skin folds can sometimes predispose to skin yeast and infections, it doesn't always and surgical incisions should not be based on conditions assumed to exist. Rather, care providers should be aware of the possibility and make decisions based on actual evidence of problems rather than an assumption of pathology.

Vertical Incisions Do Not Improve Outcomes


As noted, cesarean incision choice for very heavy women was usually based on traditional teachings and biased assumptions. When someone actually took the time to research these hypotheses, however, it was found that vertical incisions were no better, and in some studies were actually far more risky.

Let's do a quick review of the medical literature on this topic.

Vertical is More Risky

The Alanis 2010 study discussed above studied women with a BMI over 50. They found better outcomes with transverse incisions:
Vertical abdominal incisions were associated with increased operative time, blood loss, and vertical hysterotomy...Our results also support the use of Pfannenstiel incisions in obese patients with a large panniculus.
D'heureux-Jones 2001 also found that vertical incisions were associated with greater blood loss and poorer outcomes. They recommended a Pfannenstiel incision too.

In some studies the findings were more dramatic. In Wall 2003, vertical incisions presented 12x the risk for wound complications compared to transverse incisions. TWELVE TIMES the risk. That's a tremendous difference.

Thornburg 2012 found that the majority of wound complications (WC) were found in the vertical incision group (45.7% rate in vertical incisions, vs. 11.6% in transverse incisions). That's a very significant difference. They concluded:
In morbidly obese women both infectious and separation type WC are more common in vertical than low transverse incisions; therefore transverse should be preferred.
Vertical is No Improvement

Critics would point out that a number of studies did not find a statistically significant difference between vertical vs. low transverse incisions (Sutton 2016, Vermillion 2000McLean 2012, Houston and Raynor 2000Brocato 2013, and Bell 2011). Many researchers cite these studies to argue that there is no difference between incisions and the choice should be completely left to the surgeon's preference.

However, if they read the full text of these studies, the data usually showed a very clear trend towards more complications with vertical incisions. For example, 5 of the 6 above-cited studies found nearly double or more the rate of problems in the vertical incision group, yet the difference did not rise to statistical significance:
  • Bell 2011 found wound complications in 14.6% of the vertical incision group vs. 7.6% in the low transverse group
  • Vermillion 2000 found a 23% wound infection rate in the vertical group vs. a 6% rate in the low transverse group
  • McLean 2012 found a 20% rate of wound separation in the vertical group vs. a 10% rate in the low transverse group
  • Sutton 2016 found a 26.3% rate of wound complications in the vertical group vs. 14.8% in the low transverse group 
  • Brocato 2013 found 2.7x the risk for wound complications in the vertical group
The problem here is that the number of patients in the vertical incision groups in these studies was extremely small and that is what is confusing the outcome. Bell 2011 had only 41 patients with vertical incisions; Brocato 2013 had only 45; Sutton 2016 had only 57; McLean 2012 had only 25; and Houston and Raynor 2000 had only 15 patients in their vertical comparison groups. Basically, the studies showing no significant difference had too few vertical incisions to be rigorously compared. 

The fact that the differences didn't rise to statistical significance doesn't mean that vertical incisions were just as safe; it just means that these studies were simply underpowered to show statistical significance between the groups. 

Summary

Larger studies do need to be done, but the majority of the evidence we have so far suggests that vertical incisions perform no better and often perform worse in obese women. Low transverse incisions are usually associated with better outcomes. 

Bottom line, vertical incisions are associated with increased rates of wound complications, blood loss, and infections in obese women, even very obese women, as we have written about extensively before. In addition, vertical incisions are far more scarring and challenging to a woman's self-esteem and should ideally be avoided on that basis alone. It's also worth noting that although the best incision for each woman's unique anatomy and situation must be judged on an individual basis, low transverse incisions have been used successfully even in women of 400-500 pounds without poor outcomes.

Vertical Skin = Vertical Uterine Incisions

Image from swcare.net

Another problem is that several of these studies (Bell 2011, Alanis 2010, Sutton 2016) have also shown that when vertical skin incisions are done, they result in a higher rate of vertical uterine incisions (hysterotomies). Bell 2011 found that nearly 2/3 of all vertical skin incisions in obese women resulted in a vertical uterine incision as well.

A vertical uterine incision results in a riskier surgery, with more blood loss, a more difficult recovery, and a higher rate of uterine rupture in future pregnancies. In most OB practices, it limits a woman's future delivery choices to automatic repeat cesareans, which may have tremendous long-term health implications for the mother due to increased placental abnormalities and intraoperative injuries. The Alanis 2010 authors noted:
Vertical abdominal incisions were associated with vertical hysterotomy in our study, usually a result of inadequate access to the lower uterine segment. When the incision extends into the contractile portion of the uterus, a vertical hysterotomy has a profound impact on future pregnancy. Therefore, it is important to incorporate practices, like transverse abdominal incisions, that facilitate low uterine incisions.
Doing a vertical incision routinely and without pressing need in high BMI women subjects them to more risk and potentially limits their future reproductive choices. As a result, one reviewer concluded that in obese women:
Low transverse skin incisions and transverse uterine incisions are definitely superior and must be the first option.
In recent years, more and more OBs began to use low transverse incisions in women of size. In fact, today the vast majority of high BMI women ─ even very high BMI women ─ who have cesareans have low transverse incisions. This is encouraging progress.

Still, many OBs cling to their teaching and use a vertical incision at a higher rate for obese women, especially "morbidly obese" and "super obese" women.

2016 survey of OBs revealed that while 84% preferred a transverse incision for obese women, 16% still preferred other incisions (usually vertical).

McLean 2012 found that 11% of high-BMI women were still being subjected to the riskier vertical incisions; Marrs 2014 (a very large, multi-region, multi-center study; see below) found that vertical incisions were used in a whopping 19% of high BMI women.

Between these documents, that's a vertical incision in about 1 out of every 5-10 cesareans done in obese women. So while progress has been made, vertical incisions are still distressingly common, and they are still putting the well-being of women of size at risk.

But What About That 2014 Study?



Some doctors have pointed to the Marrs 2014 study to justify continuing with vertical incisions. This was the one study that seemed to disprove the idea that transverse was better. (See the first abstract below, full text can be found here.)

This was a secondary analysis of the MFMU registry, which examined data from cesareans in 19 different regional hospitals. This analysis looked at incision complications after cesarean in women with a BMI of 40 or more. Since it was the largest study of its kind in obese women (597 vertical incisions, 2603 transverse incisions), its conclusions were assumed to be far more powerful and definitive.

In the study, wound complications were found in 1.7% of women with transverse incisions vs. 4.2% of women with vertical incisions. In other words, more than double the rate of problems were found with vertical incisions. Simple conclusion to be drawn, right? Not quite.

In its univariate (one variable) analysis, transverse was shown to be the safer incision. But in its multivariate (multiple variable) analysis, the opposite was found ─ vertical seemed better. This conclusion was trumpeted far and wide because now there was research ammo to keep justifying the use of vertical incisions in high-BMI women.

However, a re-analysis of the data shows that their conclusion was wrong and transverse was better after all. Turns out they used the wrong figures in their multivariate analysis and so got the wrong conclusion. Instead of vertical being the better incision, it was actually transverse that had the best outcomes. The authors issued a retraction in July of 2017 and stated:
The original publication reported that univariate analysis showed that a vertical skin incision in obese women undergoing Cesarean delivery was associated with a higher odds ratio for wound complications than a transverse skin incision. Multivariable analyses showed a reversal of the association (i.e. the odds of wound complications were lower in women with a vertical skin incision). However, there was an error in the way the variable was entered in the logistic analysis. Re-analysis with the correct coding of the variable indicates that a transverse skin incision is associated with decreased odds of wound complication compared to a vertical skin incision.
Well, bravo that they finally published a retraction to the previous study and a corrected abstract...3 years after the fact. (I have published the abstracts to both below for comparison.)

At least they actually printed a retraction and admitted their error. Usually these are just glossed over. But I'm irritated because the damage has been done. How many OBs have gotten the wrong impression and won't see the retraction? How many young doctors have been erroneously taught that vertical incisions were superior for high BMI women?

When you search online, the original manuscript with its erroneous conclusions still pops up without any corrections, and is still being cited by some doctors as evidence that a vertical incision is just as good or better.

How many high-BMI women have had the more dangerous vertical incision in the meantime and how many will continue being subjected to it because of the error in that original study? How many medical schools and textbooks will continue teaching that vertical incisions are better?

Grrrrrrrr. Mistakes happen, but this is a mistake with long-lasting implications for larger women. I can't believe they were sloppy enough to make this mistake in the first place and then not discover it for three years. I also question whether they are doing enough to reach out to correct the mistaken teaching and care practices that are in place because of this egregious error. If it's not addressed aggressively, incorrect teachings and practices will remain in place, and that could have a lot of negative health implications for women of size.

Conclusion

Low transverse cesarean scar in a high BMI woman;
these are usually minimally noticeable after a few years


A vertical skin incision on a high BMI woman has far more noticeable
scarring and potential impact on her self-esteem

The cesarean rate in obese women is unconscionably high. Some cesareans are needed of course, but many cesareans in high BMI women are planned pre-labor cesareans, and many labor cesareans could probably be avoided with more patience, fewer inductions, a more lenient surgical threshold, and different management in labor.

But the fact of the matter is that around half or more of all obese mothers in many areas of the U.S. are being subjected to cesareans. The rate of wound complications increases with BMI in a dose-respondent manner, so the question of how to lower complications in obese women is extremely pressing.

Proper choice of cesarean incision is one key way to reduce complications in obese women. Thankfully, most OBs recognize that a low transverse is the best incision in high BMI women, and use it most of the time.

However, some OBs continue to insist that vertical is better, especially as BMI increases. One 2014 study found only a 2% rate of vertical incisions in women with BMIs between 30 and 40, but this increased to more than 15% in women with a BMI over 50. The fact that the Marrs MFMU study found that vertical incisions were used in 19% (nearly 1 in 5 cesareans of obese women) in women with a BMI over 40 is quite alarming. These high rates are risking the health and well-being of women of size.

Furthermore, OBs have even been known to use a vertical incision to discourage their "morbidly obese" patients from having more children. This is appalling example of weight stigma. Here is one woman's story:
When she came in to discuss my surgery, the OB sat down and asked me if I wanted my tubes tied while she was in there. I was shocked and told her no, that this was my first child, and I didn't want to make decisions like that at the moment. And she countered with a speech that boiled down to 'You are too fat to have any more children, you shouldn't even be having this one, and if I had anything to do with it, you wouldn't be.'...[Afterwards] the hateful OB informed me that the kind of incision that they made in my uterus will make it incredibly dangerous for me to attempt another pregnancy...a subsequent pregnancy could cause the uterus to rupture and I would die horribly from a hemorrhage.
Granted, there are sometimes circumstances which compel the use of a vertical incision. An extremely large belly makes it harder to locate anatomical landmarks; sometimes the panniculus is so large it is impossible to place an incision beneath it; sometimes there is an active skin infection present in the folds; sometimes other factors like fetal or placental position make a different incision safer. In those situations, there are other incision options, including a vertical or a higher transverse (Joel-Cohen) incision. However, this mother had none of these considerations. The incision seems to have been chosen purely to punish the mother and to strongly discourage further children despite her refusal of sterilization.

Whatever the reasons, there is no justification for such a high rate of vertical incisions still being used in heavy women. Medical schools and educational materials need to stop teaching that a vertical incision is the incision of choice for high BMI women.

Research CLEARLY shows that a vertical incision performs no better than a transverse one in obese women and in most research, is actually associated with worse outcomes. NO study now shows a better outcome with vertical incisions. 

The bottom line is that incision choice for each woman of size must be evaluated on its individual circumstances, but a low transverse incision should be the default choice in nearly all high BMI women. As one OB said in a conference presentation to colleagues:
The bottom line is that vertical incisions should not be used in obese patients...Vertical incisions are being used less and less in these patients, but just don't do it.

References

Original Article

Am J Obstet Gynecol. 2014 Apr;210(4):319. doi: 10.1016/j.ajog.2014.01.018. Epub 2014 Feb 20. The relationship between primary cesarean delivery skin incision type and wound complications in women with morbid obesity. Marrs CC, Moussa HN, Sibai BM, Blackwell SC. Full text here.
OBJECTIVE: We sought to evaluate the relationship between skin incision, transverse or vertical, and the development of wound complications in women with morbid obesity requiring primary cesarean delivery (CD). STUDY DESIGN: Morbidly obese women (body mass index ≥40 kg/m(2)) undergoing primary CD at ≥24 weeks' gestation were studied in a secondary analysis of a multicenter registry. Clinical characteristics and outcomes were compared between women who had transverse vs vertical skin incision. The primary outcome was composite wound complication (infection, seroma, hematoma, evisceration, fascial dehiscence) and composite adverse maternal outcome (transfusion, hysterectomy, organ injury, coagulopathy, thromboembolic event, pulmonary edema, death). Multivariable logistic regression analyses were performed to adjust for confounding factors. RESULTS: In all, 3200 women were studied: 2603 (81%) had a transverse incision and 597 (19%) had a vertical incision. Vertical skin incision was associated with lower risk for wound complications (adjusted odds ratio, 0.32; 95% confidence interval, 0.17-0.62; P < .001) but not with composite adverse maternal outcome (adjusted odds ratio, 0.72; 95% confidence interval, 0.41-1.25; P = .24). CONCLUSION: In morbidly obese women undergoing a primary CD, vertical skin incision was associated with a lower wound complication rate. Due to the selection bias associated with utilization of skin incision type and the observational nature of this study, a randomized controlled trial is necessary to answer this clinical question.
Retraction and Revised Conclusion

Am J Obstet Gynecol. 2017 Jul;217(1):85. doi: 10.1016/j.ajog.2017.06.002. Removal notice to The relationship between primary cesarean delivery skin incision type and wound complications in women with morbid obesity: Am J Obstet Gynecol 2014;210:319.e1-4. Marrs CC, Moussa HN, Sibai BM, Blackwell SC. PMID: 28648694
This article has been removed: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been removed at the request of the Editors-in-Chief and Authors. The original publication reported that univariate analysis showed that a vertical skin incision in obese women undergoing Cesarean delivery was associated with a higher odds ratio for wound complications than a transverse skin incision. Multivariable analyses showed a reversal of the association (i.e. the odds of wound complications were lower in women with a vertical skin incision). However, there was an error in the way the variable was entered in the logistic analysis. Re-analysis with the correct coding of the variable indicates that a transverse skin incision is associated with decreased odds of wound complication compared to a vertical skin incision.

Studies Which Show Poorer Outcome with Vertical Incisions in Obese Women
Small Studies Which Show No Statistically Significant Difference
My Previous Writings on Skin Incisions in High BMI Cesareans

Saturday, August 12, 2017

VBAC Prediction Models: Actual Results are Better than Predicted

Original checklist by Melek Speros

Many women with a prior cesarean who want a Vaginal Birth After Cesarean (VBAC) are counseled that they are not "good candidates" for a trial of labor because a VBAC Prediction Model suggests that they have a very low chance of VBAC "success."

In particular, the MFMU VBAC Prediction Model considers weight a strong negative predictive factor for VBAC. As a result, many obese women are told that their chances for VBAC are very low, implying they might as well just sign up for the repeat cesarean now. Many doctors strongly discourage VBAC in women with a high Body Mass Index (BMI). Some hospitals and practices even have BMI restrictions on who is allowed to have a Trial of Labor After Cesarean (TOLAC).

Similarly, many women of color are discouraged from pursuing a VBAC because they are told that they have a lower chance of success. Imagine the negative pressure against VBAC when these two factors intersect in a high BMI woman of color!

However, a recent study from UCLA actually examined how predictive this model was in their institution. They found that it was highly accurate for women predicted to have a very strong chance of VBAC. But to their surprise, they found it was NOT that accurate for women predicted to have a low or moderate chance of VBAC.

The difference was particularly striking for those predicted to have a low chance of a VBAC. 57% of this group actually had a VBAC, when only 29% were predicted to have one, nearly twice the expected rate. 

Of particular note, the authors also documented that, unlike the MFMU prediction model, neither BMI nor ethnicity were associated with lower rates of VBACs in their institution. 

This is especially meaningful to the many women of color and women of size who have been actively discouraged from pursuing a VBAC because of the MFMU prediction model. It also suggests to me that risk perception and the way women are managed in labor (higher induction rates and a lower surgical threshold are common in TOLAC in high BMI women, for example) may influence VBAC "success."

Personally, my VBAC prediction scores were extremely low (22%!) due to multiple risk factors, yet I went on to have not one but two VBACs. If I had let negative predictions discourage me, I would have missed out on my VBACs and their easier recoveries, and I would have been exposed to increased risk for placenta previa and accreta by having additional scars on my uterus.

I know from my work with the International Cesarean Awareness Network (ICAN) that many women are told they have a poor chance at a VBAC and yet go on to have a VBAC anyhow. In fact, few women meet all the "ideal conditions" for VBAC success, yet most will go on to have a VBAC.

If you have been told that you are not a good candidate for VBAC because of your BMI, your race, or various other factors, remember this study and the anecdotal experience of so many women in ICAN. It's okay to consider risk factors, but don't let them overly influence your decision. Group risk factors don't predict what will happen with any one individual. 

No one can guarantee you a VBAC, but neither can anyone reliably predict who will not have a VBAC when given a fair and adequate chance to labor. As the authors conclude in the UCLA study:
As part of efforts to safely decrease cesarean rates in the United States, patients interested in TOLAC (and their providers) should not be discouraged by a low predicted success score.

Reference

AJP Rep. 2017 Jan;7(1):e31-e38. doi: 10.1055/s-0037-1599129. Validation of a Prediction Model for Vaginal Birth after Cesarean Delivery Reveals Unexpected Success in a Diverse American Population. Maykin MM, Mularz AJ, Lee LK, Valderramos SG. PMID: 28255520  Full free text here.
OBJECTIVE: To investigate the validity of a prediction model for success of vaginal birth after cesarean delivery (VBAC) in an ethnically diverse population. METHODS: We performed a retrospective cohort study of women admitted at a single academic institution for a trial of labor after cesarean from May 2007 to January 2015. Individual predicted success rates were calculated using the Maternal-Fetal Medicine Units Network prediction model. Participants were stratified into three probability-of-success groups: low (<35%), moderate (35-65%), and high (>65%). The actual versus predicted success rates were compared. RESULTS: In total, 568 women met inclusion criteria. Successful VBAC occurred in 402 (71%), compared with a predicted success rate of 66% (p = 0.016). Actual VBAC success rates were higher than predicted by the model in the low (57 vs. 29%; p < 0.001) and moderate (61 vs. 52%; p = 0.003) groups. In the high probability group, the observed and predicted VBAC rates were the same (79%). CONCLUSION: When the predicted success rate was above 65%, the model was highly accurate. In contrast, for women with predicted success rates <35%, actual VBAC rates were nearly twofold higher in our population, suggesting that they should not be discouraged by a low prediction score.

Monday, July 31, 2017

Obesity and Joint Replacement, Part 2: Does Losing Weight First Improve Outcomes?


We have been discussing obesity and joint replacement operations, specifically knee replacements and hip replacements, and the common practice of denying these to people of size.

In Part One, we discussed the highly questionable ethics behind denying "obese" people joint replacement operations or requiring that they undergo weight loss counseling or bariatric surgery first. These practices keep many people of size from accessing joint replacements and improving their functional abilities and pain levels, sentencing many larger people to the difficulties of dealing with mobility challenges and a poorer quality of life.

Today, we discuss the data on whether losing weight before joint replacement actually improves long-term outcome, as so many doctors insist it will. Up till now it has been assumed that it will, but a closer look at longer-term research calls this assumption into question. Indeed, several recent studies that suggest that losing weight before knee replacement surgery does NOT improve outcome and might even result in worse outcomes.

Does Weight Loss Before Knee Replacement Help?

Of course, some readers will be asking, why not consider weight loss? If it will reduce the physical load on the joint and lessen pain and wear, why not pursue weight loss?

The answer is complicated.

It certainly seems logical that it would be advantageous to lose weight before an operation to replace a weight-bearing joint. There would be less weight and therefore less force on the joint, right?

And to be fair, there's definitely research that shows modest improvements in functionalityjoint force load, and pain levels with weight loss in patients with knee pain.

However, like most weight-loss research, these studies usually follow patients only short-term so the usual weight rebound effect is conveniently overlooked or minimized.

Even studies that promote weight loss for knee osteoarthritis admit (my emphasis):
Whether substantial weight loss can delay or even reverse the symptoms associated with osteoarthritis remains to be seen.
In other words, they do NOT have long-term proof that weight loss improves outcomes; they just assume it does because short-term studies (often just a few months) suggest some improvement.

This is the problem with nearly all weight-loss research; it only follows the patients long enough to show some benefits of a quick loss, but rarely follow patients long-term because many of the benefits are lost and most of the weight is regained (and often more), and doctors don't want to acknowledge that.

Even the usual recommendation to "lose just 5-10%" of a person's weight is problematic. While some research indicates modest benefits, research is actually quite limited on the long-term effects of such a loss. And most dieters do not manage or just barely manage that 5-10% weight loss over time.

Reviews of long-term research shows that for most people, few maintain the weight loss over time, most of the weight loss is regained with time, and many people rebound to higher weights or greater abdominal fat than they began with. There are biological reasons for this weight regain; it's not just about willpower.

Furthermore, weight loss can present risks as well as benefits, frequent weight fluctuation can be detrimental to health, and intentional weight loss/"dietary restraint" is one of the strongest predictors of long-term weight gain.

As a result, some care providers are now recommending that obese patients strive for weight stability rather than weight loss, and that the emphasis be placed on improving health habits and health measures instead of reducing a number on a scale.

Unfortunately, because short-term research shows modest improvements in joint function with weight loss, doctors have extrapolated this to assume that significant weight loss will improve long-term outcomes for joint replacement surgeries. As a result, some deny joint replacement to people above a certain BMI, practically mandate attendance at weight loss programs first, browbeat their patients about weight loss, or strongly push for bariatric surgery instead.

But does weight loss before joint replacement improve outcomes?

Weight Loss Before Joint Replacement 

In two recent new studies, the common assumption that having patients lose weight before having knee replacement surgery will automatically improve outcomes is questioned.

In a California study, only 12.4% of more than 10,000 knee replacement patients studied and 18% of more than 4000 hip replacement patients  managed to lose at least 5% of their starting weight in the year before their surgery. Around 75% of both groups stayed stable. Those who did manage to lose weight before knee replacement surgery did no better than those who did not lose weight before surgery. They had similar rates of surgical site infections and re-admissions for complications.

This certainly calls into question how helpful weight loss supposedly is before knee replacement.

In a companion study, those who lost weight before joint replacement surgery and managed to keep it off afterwards actually did worse than those whose weight stayed stable. The weight loss knee replacement group had more hospital re-admissions than those who did not lose weight. Furthermore, the hip replacement group who lost weight had more deep-site surgical infections. The authors noted:
These findings raise questions about the safety of weight management before total replacement of the hip and knee joints.
Why this increase in infections occurred is not clear. One theory is that when people are placed on a significantly low-calorie diet, nutrition can be impaired. It is difficult to get the proper amounts of all the nutrients when caloric intake is too low, and diets for these mobility-impaired people are often quite low-calorie because increasing exercise is difficult. As a result, some people with significant weight loss or chronic dieting histories develop nutrient deficiencies, and these may impair immune function. Research confirms that people with nutrient deficiencies have a greater risk for infections and other complications after joint surgery.

So while weight loss may reduce stress on the joint, nutrient deficiencies from this weight loss may affect immune function and ability to "bounce back" after surgery, negating any potential benefits of weight loss.

Furthermore, many people who lose substantial weight before joint replacements gain back that weight and more after the surgery. The end result of weight loss before joint replacement may be that the patient ends up weighing MORE later on, as one study found:
A patient with [hip replacement] had increased risk of important post-surgical weight gain of 12% (OR = 1.12, 95% CI, 1.08, 1.16) for every kilogram of pre-operative weight loss...Patients less than 60 years and who have lost a substantial amount of weight prior to surgery appear to be at particularly high risk of important post-surgical weight gain.
Ironically, requiring or strongly encouraging patients to lose a substantial amount of weight prior to joint replacement may backfire and ultimately add to the patient's weight, not lessen it. Yet most doctors continue to demand weight loss before joint replacement. Only now the emphasis is on weight loss via bariatric surgery instead.

Quote from Ragen Chastain, found here.

What About Bariatric Surgery First?

Because bariatric surgery is one of the only ways to lose weight in the long term (though it comes with many other complications and ususally involves some weight regain), many orthopedic surgeons are forming de-facto partnerships with bariatric surgeons.

As a result, many people of size are effectively blackmailed into weight loss surgery by BMI restrictions on joint replacements. 

One study from the Mayo Clinic states, "Morbidly obese individuals with severe degenerative joint disease who are considered unsuitable for arthroplasty because of excess weight should be considered for bariatric surgery."

Another surgeon reports that he accepts patients for knee replacements up to a BMI of 50, but after that he refers them for bariatric surgery first. (Because it makes SO much sense for someone too "at-risk" for one type of surgery to undergo a different type of surgery instead.)

Yet the common assumption that bariatric surgery should be promoted because it would surely improve outcomes in "morbidly obese" patients with significant osteoarthritis should also be questioned.

Some research does indicate improved outcomes in those who had bariatric surgery before joint replacement. And one recent study that looked only at short-term (90 days!) complications found lower rates of complications in those who had had bariatric surgery. Of course, the media was all over this study and it has been widely cited to justify requiring weight loss surgery.

However, other research does not support better outcomes with bariatric surgery, yet the press conveniently ignores that. In one study, complications were actually higher in the group with recent bariatric surgery (less than 2 years). The authors concluded:
Bariatric surgery prior to TJA [Total Joint Arthroplasty] may not provide dramatic improvements in post-operative TJA surgical outcomes. 
In another study from a major research hospital, researchers found an increased rate of joint replacements in bariatric patients who had experienced large or very rapid weight loss. They noted, "These results contradict the tenant that weight loss is universally protective against arthritis and merit larger prospective investigations."

Another recent study did not find improved outcomes in those who had had bariatric surgery before joint replacement. Indeed, many had worse outcomes instead, needing more revision surgeries afterwards.

This was echoed in a recent large retrospective cohort study that found worse outcomes in the group that had bariatric surgery first, compared to high-BMI people who did not. The WLS group had more infection, pneumonia, blood clots, heart issues, revisions, and manipulations of the prosthetetic.

recent meta-analysis found no significant benefit from bariatric surgery before joint replacement. The authors concluded:
For most peri-operative outcomes, bariatric surgery prior to THA or TKA does not significantly reduce the complication rates or improve the clinical outcome. This study questions the previous belief that bariatric surgery prior to arthroplasty may improve the clinical outcomes for patients who are obese or morbidly obese.
It may be that the potential benefits of reducing the load on the joint via weight loss from bariatric surgery may be outweighed by the nutrient deficits that are so common after weight loss surgery, even non-restrictive procedures. It may also be that the stresses on the body from rapid weight loss cause long-term damage to the body's ability to repair itself.

While some bariatric surgery patients have good outcomes and health improvement from the WLS, others have terrible outcomes, with significant nutritional deficits (sometimes despite supplements) and physical health problems. Some even die from the surgery or its after-effects. The problem is that you don't know which outcome group you are going to be in until after you've had the surgery. To strongly pressure joint replacement patients into bariatric surgery first means doctors are engaging in a high-stakes gamble with their patients' lives and quality of life.

And if joint replacement surgery at larger sizes is "too dangerous," why isn't weight loss surgery at larger sizes also too risky? Funny how patients are too fat for one surgery but surgeons can't wait to usher them into the Operating Room for WLS.

There are good reasons to question the common recommendation to have bariatric surgery before joint replacement. WLS is dangerous in and of itself, it often results in significant long-term nutrient deficits and other health problems, and it may not improve long-term outcomes for joint replacement.

However, as always, every person gets to make their own health decisions. Some people choose to have bariatric surgery before joint replacement and they have the right to do that. Others choose not to, and they also should have the right to do that. It's a choice with many pros and cons but one that should not be forced upon someone, which many doctors are essentially doing by denying joint replacement without bariatric surgery first.

In the past, care providers rarely studied whether or not bariatric surgery actually improved outcomes; they just assumed it will because it seems logical. But recent research shows there is good reason to question whether bariatric surgery really improves long-term outcome after all.

Mitigating Risk Through Better Management

Critics will no doubt point out that the risk for blood clots and post-operative infection are higher in obese patients and this is why they are concerned about operating on this group. This is true, and obese patients should be counseled about this fact. For example, one study found 6.7x the risk for infection in obese knee replacement patients, and 4.2x the risk for infection in obese hip replacement patients. The risk for infection is particularly strong among diabetics with a BMI over 40.

However, remember the dangers of using relative risk to discuss risk/benefit ratios; it can distort one's perception of risk. It is more helpful to use absolute numerical values so the magnitude of risks patients are assuming is more clear. One very large British study found that for knee replacements, risk for blood clots was increased from 2.0% to 3.3% and risk for infection from 3.0% to 4.1%, in obese patients with total knee replacements. For hip replacements, the risk for blood clots was increased from 2.2% to 3.3% and the risk for infection from 1.6% to 3.5% in obese patients. The authors noted (my emphasis):
Whilst an increased risk of wound infection and DVT/PE was observed amongst obese patients, absolute risks remain low and no such association was observed for MI, stroke and mortality.
However, the most important thing to point out is that an increased infection and clotting risk may be at least partly due to mismanagement of obese patients. Re-examining and changing the management protocols of these patients may improve outcomes independent of weight loss. 

For example, research shows that obese patients are chronically under-dosed with many medications. This is particularly relevant in antibiotics for preventing and treating infections, and in thromboprophylaxis medications for preventing blood clots after surgery. In other words, the two biggest risks of surgery in high-BMI patients may actually be largely preventable.

Obese patients, especially "morbidly-obese" (BMI 40+) and "super-obese" (BMI 50+) patients, are at particular risk for infections and may require larger initial antibiotic dosesextended or more frequent dosing regimens, use of more than one type of antibiotic, and perhaps topical infusions of antibiotics during surgery. This may help reduce their increased risk for infection after joint replacement surgery.

One recent study on infection in obese joint replacement patients strongly raised this issue of antibiotic underdosing. The authors found that above 100 kg (~220 lbs.), the rate of infections rose strongly. They noted that most patients in the study, regardless of BMI, were treated with a uniform dose (1.5g) of pre-op antibiotics and speculated that an increased antibiotic dose would help lower the rate of infections in this group. They stated:
The link between obesity and infection may be explained by several factors, but under-dosing of antibiotics is probably the most important to consider.
They also noted that noted that research examining the question of proper antibiotic dosage for obese patients undergoing joint replacement surgery was lacking. The problem of underdosing antibiotics in obese patients has been acknowledged in obstetric and bariatric surgery for several years. Why is it only NOW being brought up in orthopedic surgery?

Underdosing issues go beyond antibiotics. Research suggests that many obese patients are under-dosed with anti-clotting agents like heparin. One study found that weight-adjusted dosing cut the rate of blood clots in obese patients after surgery from 2.0% to 0.54% without increasing the risk for bleeding. Another study found that an extended prophylaxis period of anti-clotting agents lowered the risk for clots significantly, also without increasing bleeding.

Other surgical management protocols for obese patient need review as well. Some research suggests that surgical drains, often placed prophylactically in obese patients, have no benefit or may actually do more harm than good. Although further research is needed, one research review suggested omitting routine surgical drains in obese patients during joint replacement surgery.

As noted previously, another very interesting set of recent studies suggests that "morbid obesity" is less important that serum albumin levels on major complications like mortality and infections in joint replacement surgery. Serum albumin levels are an indicator of liver and kidney function but can also indicate nutrition status; obese people may be more at risk for malnutrition because of chronic dieting, highly restrictive intakes, or malabsorptive procedures like gastric bypass. Improving joint replacement outcomes might need to focus on measuring and fixing albumin levels and other nutrient deficits before surgery.

Bottom line, if the real concern is preventing poor outcomes, then perhaps the best approach is not to deny all high-BMI patients access to this surgery, but rather to lower morbidity by improving care for them instead via:
  • Utilizing weight-based dosing more uniformly in antibiotics and blood clot prevention drugs 
  • Using extended, adjunctive or more frequent antibiotic dosing regimens 
  • Avoiding routine prophylactic surgical drains 
  • Screening for and optimizing albumin and other nutrient levels before surgery
Ironically, a lot of the research on improving surgical outcomes in very obese patients is only done with bariatric surgery. It is past time to improve outcomes in high-BMI people in other types of surgery as well, including joint replacement surgery, instead of having to just extrapolate from bariatric surgery studies.

We need to know through evidence-based trials what the best protocols are for obese people undergoing joint replacement surgery. And in order to do that, we need for people of size to actually be given access to this surgery.

Summary

Sadly, even today, many orthopedic surgeons refuse to do knee replacements or hip replacements on anyone with a BMI over 35 or over 40 (or sometimes less).  In many places in the U.K., for example, people with a BMI over 35 have been routinely denied joint replacements and other surgeries. Some even deny joint replacements to those with a BMI over 30.

They do this because surgery is more technically challenging in very heavy people and because they view obesity as a voluntary condition brought on by poor lifestyle choices. They feel that losing weight is mostly a matter of willpower and choices, despite plenty of evidence to the contrary, and they feel they are doing their patients a favor by making them lose weight.

Surgeons also justify BMI restrictions by pointing out the short-term risks associated with orthopedic surgery in high-BMI people. They suggest that higher complication rates and somewhat lower functional outcomes justify denying surgery to this group and/or requiring weight loss or even bariatric surgery before joint replacement.

However, other surgeons are questioning the ethics of denying joint replacement surgery to high-BMI patients. They note that even very fat patients usually have good long-term outcomes from the surgery.

They recognize that the tremendous improvement in mobilityquality of lifeknee function, and pain relief is worth the trade-off of a potentially increased risk for mild short-term morbidity. Many are willing to proceed with joint replacement surgery in high-BMI patients as long as they have been given informed consent about the benefits and risks.

It is reasonable to counsel obese patients about the potential risks of a higher weight before surgery, especially if they have co-morbidities like diabetes. However, the counseling should cover both risks and benefits. It should acknowledge that the magnitude of risk is relatively modest in most obese patients and that most have very good long-term results from both knee replacement surgery and hip replacement surgery.

Patients can also be counseled about the potential benefits of weight loss before joint replacement surgery, as long as the data used is realistic and the potential risks of weight loss are also covered. But weight loss should not be required in order to access such surgery because research is contradictory on whether this is helpful. Short-term research shows some benefits, but longer-term research shows little benefit and sometimes even harm. Furthermore, the risks of weight loss, yo-yo dieting, and bariatric surgery should not be overlooked. More research is needed, but requiring weight loss before surgery is certainly not evidence-based. The truth is that the evidence is mixed and the choice should be left to the patient.

Joint replacement surgery in very obese patients is technically harder and does carry risks. However, the magnitude of this risk is modest and the potential for improvement in quality of life is very strong. Restricting high-BMI people from joint replacement surgery or requiring them to lose weight in order to access this surgery is NOT justified or ethical.

Rather, the risks are a call to surgeons to further examine the long-overlooked issue of how they manage obese patients. Risks can most likely be mitigated by proper medication dosing and more optimal surgical management of high-BMI patients.

Instead of restricting joint replacement or requiring weight loss in high BMI patients, orthopedic surgeons should be focusing on how they can improve outcomes in this group through modifications to surgical management protocols.


References

General Information about Joint Replacement

Weight Loss Before Joint Replacement

Bone Joint J. 2014 May;96-B(5):629-35. doi: 10.1302/0301-620X.96B5.33136. The risk of surgical site infection and re-admission in obese patients undergoing total joint replacement who lose weight before surgery and keep it off post-operatively. Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. PMID: 24788497
This study evaluated whether obese patients who lost weight before their total joint replacement and kept it off post-operatively were at lower risk of surgical site infection (SSI) and re-admission compared with those who remained the same weight. We reviewed 444 patients who underwent a total hip replacement and 937 with a total knee replacement who lost weight pre-operatively and sustained their weight loss after surgery. After adjustments, patients who lost weight before a total hip replacement and kept it off post-operatively had a 3.77 (95% confidence interval (CI) 1.59 to 8.95) greater likelihood of deep SSIs and those who lost weight before a total knee replacement had a 1.63 (95% CI 1.16 to 2.28) greater likelihood of re-admission compared with the reference group. These findings raise questions about the safety of weight management before total replacement of the hip and knee joints.
J Arthroplasty. 2014 Mar;29(3):458-64.e1. doi: 10.1016/j.arth.2013.07.030. Epub 2013 Sep 7. The impact of pre-operative weight loss on incidence of surgical site infection and readmission rates after total joint arthroplasty. Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. PMID: 24018161
This study characterized a cohort of obese total hip arthroplasty (THA) and total knee arthroplasty (TKA) patients (1/1/2008-12/31/2010) and evaluated whether a clinically significant amount of pre-operative weight loss (5% decrease in body weight) is associated with a decreased risk of surgical site infections (SSI) and readmissions post-surgery. 10,718 TKAs and 4066 THAs were identified. During the one year pre-TKA 7.6% of patients gained weight, 12.4% lost weight, and 79.9% remained the same. In the one year pre-THA, 6.3% of patients gained weight, 18.0% lost weight, and 75.7% remained the same. In TKAs and THAs, after adjusting for covariates, the risk of SSI and readmission was not significantly different in the patients who gained or lost weight pre-operatively compared to those who remained the same.
Osteoarthritis Cartilage. 2013 Jan;21(1):35-43. doi: 10.1016/j.joca.2012.09.010. Epub 2012 Oct 6.
Clinically important body weight gain following total hip arthroplasty: a cohort study with 5-year follow-up. Riddle DL, Singh JA, Harmsen WS, Schleck CD, Lewallen DG. PMID: 23047011
...DESIGN: We used multi-variable logistic regression to compare data from one of the largest US-based THA registries to a population-based control sample from the same geographic region. We also identified factors that increased risk of clinically important weight gain specifically among persons undergoing THA. The outcome measure of interest was weight gain of ≥5% of body weight up to 5 years following surgery. RESULTS: ...A patient with THA had increased risk of important post-surgical weight gain of 12% (OR = 1.12, 95% CI, 1.08, 1.16) for every kilogram of pre-operative weight loss. CONCLUSIONS: While findings should be interpreted with caution because of missing follow-up weight data, patients with THA appear to be at increased risk of clinically important weight gain following surgery as compared to peers. Patients less than 60 years and who have lost a substantial amount of weight prior to surgery appear to be at particularly high risk of important post-surgical weight gain. 
Arthritis Care Res (Hoboken). 2013 May;65(5):669-77. doi: 10.1002/acr.21880. Clinically important body weight gain following knee arthroplasty: a five-year comparative cohort study. Riddle DL, Singh JA, Harmsen WS, Schleck CD, Lewallen DG. PMID: 23203539
...METHODS: We used one of the largest US-based knee arthroplasty registries and a population-based control sample from the same geographic region to determine whether knee arthroplasty increases the risk of clinically important weight gain of ≥5% of baseline body weight over a 5-year postoperative period. RESULTS: Of the persons in the knee arthroplasty sample, 30.0% gained ≥5% of baseline body weight 5 years following surgery as compared to 19.7% of the control sample. The multivariable-adjusted (age, sex, body mass index, education, comorbidity, and presurgical weight change) odds ratio (OR) was 1.6 (95% confidence interval [95% CI] 1.2-2.2) in persons with knee arthroplasty as compared to the control sample. Additional arthroplasty procedures during followup further increased the risk for weight gain (OR 2.1, 95% CI 1.4-3.1) relative to the control sample. Specifically, among patients with knee arthroplasty, younger patients and those who lost greater amounts of weight in the 5-year preoperative period were at greater risk for clinically important weight gain. CONCLUSION: Patients who undergo knee arthroplasty are at an increased risk of clinically important weight gain following surgery. The findings potentially have broad implications to multiple members of the health care team. Future research should develop weight loss/maintenance interventions particularly for younger patients who have lost a substantial amount of weight prior to surgery, as they are most at risk for substantial postsurgical weight gain.
Bariatric Surgery Before Joint Replacement 

Bone Joint J. 2015 Nov;97-B(11):1501-5. doi: 10.1302/0301-620X.97B11.36477. Bariatric surgery does not improve outcomes in patients undergoing primary total knee arthroplasty. Martin JR, Watts CD, Taunton MJ. PMID: 26530652
Bariatric surgery has been advocated as a means of reducing body mass index (BMI) and the risks associated with total knee arthroplasty (TKA). However, this has not been proved clinically. In order to determine the impact of bariatric surgery on the outcome of TKA, we identified a cohort of 91 TKAs that were performed in patients who had undergone bariatric surgery (bariatric cohort). These were matched with two separate cohorts of patients who had not undergone bariatric surgery. One was matched 1:1 with those with a higher pre-bariatric BMI (high BMI group), and the other was matched 1:2 based on those with a lower pre-TKA BMI (low BMI group). In the bariatric group, the mean BMI before bariatric surgery was 51.1 kg/m(2) (37 to 72), which improved to 37.3 kg/m(2) (24 to 59) at the time of TKA. Patients in the bariatric group had a higher risk of, and worse survival free of re-operation (hazard ratio (HR) 2.6; 95% confidence interval (CI) 1.2 to 6.2; p = 0.02) compared with the high BMI group. Furthermore, the bariatric group had a higher risk of, and worse survival free of re-operation (HR 2.4; 95% CI 1.2 to 3.3; p = 0.2) and revision (HR 2.2; 95% CI 1.1 to 6.5; p = 0.04) compared with the low BMI group. While bariatric surgery reduced the BMI in our patients, more analysis is needed before recommending bariatric surgery before TKA in obese patients.
J Arthroplasty. 2016 Sep;31(9 Suppl):207-11. doi: 10.1016/j.arth.2016.02.075. Epub 2016 Mar 15. Lingering Risk: Bariatric Surgery Before Total Knee Arthroplasty. Nickel BT, Klement MR, Penrose CT, Green CL, Seyler TM, Bolognesi MP. PMID: 27179771
...METHODS: A total of 39,014 patients were identified in a claim-based review of the entire Medicare database with International Classification of Diseases, Ninth Revision codes to identify patients in 3 groups. Patients who underwent BS before total knee arthroplasty (group I: 5914 experimental group) and 2 control groups that did not undergo BS but had either a body mass index >40 (group II: 6480 bariatric control) or <25 (group III: 26,616 normal weight control)...RESULTS: ...Medical and surgical complication incidences were greatest in group I including: 4.98% deep vein thrombosis; 5.31% pneumonia; 10.09% heart failure; and 2-year infection, revision, and manipulation rates of 5.8%, 7.38%, and 3.13%, respectively. These values were significant elevation compared to III and slightly greater than II. CONCLUSIONS: This study demonstrates that BS before total knee arthroplasty is associated with greater risk compared to both nonobese and obese patients. This is possibly due to a higher incidence of medical or psychiatric comorbidities determined in the Medicare BS patients, wound healing difficulties secondary to gastrointestinal malabsorption, malnourishment from prolonged catabolic state, rapid weight loss before surgery, and/or age.
Bone Joint J. 2016 Sep;98-B(9):1160-6. doi: 10.1302/0301-620X.98B9.38024. Does bariatric surgery prior to total hip or knee arthroplasty reduce post-operative complications and improve clinical outcomes for obese patients? Systematic review and meta-analysis. Smith TO, Aboelmagd T, Hing CB, MacGregor A. PMID: 27587514
AIMS: Our aim was to determine whether, based on the current literature, bariatric surgery prior to total hip (THA) or total knee arthroplasty (TKA) reduces the complication rates and improves the outcome following arthroplasty in obese patients. METHODS: A systematic literature search was undertaken of published and unpublished databases on the 5 November 2015...RESULTS: From 156 potential studies, five were considered to be eligible for inclusion in the study. A total of 23 348 patients (657 who had undergone bariatric surgery, 22 691 who had not) were analysed. The evidence-base was moderate in quality. There was no statistically significant difference in outcomes such as superficial wound infection (relative risk (RR) 1.88; 95% confidence interval (CI) 0.95 to 0.37), deep wound infection (RR 1.04; 95% CI 0.65 to 1.66), DVT (RR 0.57; 95% CI 0.13 to 2.44), PE (RR 0.51; 95% CI 0.03 to 8.26), revision surgery (RR 1.24; 95% CI 0.75 to 2.05) or mortality (RR 1.25; 95% CI 0.16 to 9.89) between the two groups. CONCLUSION: For most peri-operative outcomes, bariatric surgery prior to THA or TKA does not significantly reduce the complication rates or improve the clinical outcome. This study questions the previous belief that bariatric surgery prior to arthroplasty may improve the clinical outcomes for patients who are obese or morbidly obese. This finding is based on moderate quality evidence. 
Other Possible Factors

Clin Orthop Relat Res. 2015 Oct;473(10):3163-72. doi: 10.1007/s11999-015-4333-7. Epub 2015 May 21. Low Albumin Levels, More Than Morbid Obesity, Are Associated With Complications After TKA. Nelson CL1, Elkassabany NM, Kamath AF, Liu J. PMID: 25995174
BACKGROUND: Morbid obesity and malnutrition are thought to be associated with more frequent perioperative complications after TKA. However, morbid obesity and malnutrition often are co-occurring conditions. Therefore it is important to understand whether morbid obesity, malnutrition, or both are independently associated with more frequent perioperative complications...METHODS: The National Surgical Quality Improvement Program (NSQIP) database was analyzed from 2006 to 2013. Patients were grouped as morbidly obese (BMI ≥ 40 kg/m(2)) or nonmorbidly obese (BMI ≥ 18.5 kg/m(2) to < 40 kg/m(2)), or by low serum albumin (serum albumin level < 3.5 mg/dL) or normal serum albumin (serum albumin level ≥ 3.5 mg/dL)...RESULTS: Mortality was not increased in the morbidly obese group (0.14% vs 0.14%; p = 0.942)...The group with low serum albumin had higher mortality than the group with normal serum albumin (0.64% vs 0.15%; OR, 3.17; 95% CI, 1.58-6.35; p =0.001)... CONCLUSIONS: Morbid obesity is not independently associated with the majority of perioperative complications measured by the NSQIP and was associated only with increases in progressive renal insufficiency, superficial surgical site infection, and sepsis among the 21 perioperative variables measured. However, low serum albumin was associated with increased mortality and multiple additional major perioperative complications after TKA. Low serum albumin, more so than morbid obesity, is associated with major perioperative complications. This is an important finding, as low serum albumin may be more modifiable than morbid obesity in patients who are immobile or have advanced knee osteoarthritis.
HSS J. 2017 Feb;13(1):66-74. doi: 10.1007/s11420-016-9518-4. Epub 2016 Aug 16. Hypoalbuminemia Is a Better Predictor than Obesity of Complications After Total Knee Arthroplasty: a Propensity Score-Adjusted Observational Analysis. Fu MC, McLawhorn AS, Padgett DE, Cross MB. PMID: 2816787
...METHODS: TKA cases were identified from the National Surgical Quality Improvement Program from 2005 to 2013... Malnutrition was defined as hypoalbuminemia (<3.5 g/dL). Patients were classified by BMI as follows: non-obese (18.5-29.9), obese I (30-34.9), obese II (35-39.9), or obese III (≥40). Postoperative complications were compared across obesity and nutritional statuses. Multivariable propensity-adjusted logistic regressions were performed to determine associations between malnutrition, obesity, and 30-day outcomes. RESULTS: There were 71,599 cases identified, with 34,800 (48.6%) having albumin measurements...Malnutrition prevalence increased with BMI (6.1% in obese III vs. 3.7% in non-obese). With propensity-adjusted multivariable analysis, obese III was the only obesity class associated with any complication, wound complication, and reoperation. Hypoalbuminemia was a stronger and more consistent independent risk factor, for any complication, wound, cardiac, or respiratory complications, and death. CONCLUSIONS: Hypoalbuminemia is a more consistent independent predictor of complications after TKA than obesity. Strategies for medical optimization of these conditions should be investigated.
Antibiotic Dosing and Surgical Infections

Acta Orthop. 2016;87(2):132-8. doi: 10.3109/17453674.2015.1126157. Epub 2016 Jan 5. Body mass and weight thresholds for increased prosthetic joint infection rates after primary total joint arthroplasty. Lübbeke A1, Zingg M1, Vu D2, Miozzari HH1, Christofilopoulos P1, Uçkay I1,2, Harbarth S3, Hoffmeyer P1. PMID: 26731633
...We included all 9,061 primary hip and knee arthroplasties (mean age 70 years, 61% women) performed between March 1996 and December 2013 where the patient had received intravenous cefuroxime (1.5 g) perioperatively. The main exposures of interest were BMI (5 categories: < 24.9, 25-29.9, 30-34.9, 35-39.9, and ≥ 40) and weight (5 categories: < 60, 60-79, 80-99, 100-119, and ≥ 120 kg). Numbers of TJAs according to BMI categories (lowest to highest) were as follows: 2,956, 3,350, 1,908, 633, and 214, respectively. The main outcome was prosthetic joint infection. The mean follow-up time was 6.5 years (0.5-18 years). RESULTS: 111 prosthetic joint infections were observed: 68 postoperative, 16 hematogenous, and 27 of undetermined cause. Incidence rates were similar in the first 3 BMI categories (< 35), but they were twice as high with BMI 35-39.9 (adjusted HR = 2.1, 95% CI: 1.1-4.3) and 4 times higher with BMI ≥ 40 (adjusted HR = 4.2, 95% CI: 1.8-9.7). Weight ≥ 100 kg was identified as threshold for a significant increase in infection from the early postoperative period onward (adjusted HR = 2.1, 95% CI: 1.3-3.6). INTERPRETATION: BMI ≥ 35 or weight ≥ 100 kg may serve as a cutoff for higher perioperative dosage of antibiotics.
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