Stanford University doesn't support surgery for LE

kira66715

Stanley Rockson and the LE group at Stanford have a new website and this is their take on surgery for LE--and they host surgeons to give webnars through the LFR website

http://stanfordhospital.org/cardiovascularhealth/lymphaticvenous/treatments/surgery.html

Surgical Treatments for Lymphedema
Surgery is a treatment option for a very small, selected percentage of the patients who have lymphedema.

The two categories of surgical intervention that are currently available in the United States are lymphatic reconstruction and excisional surgeries

Lymphatic Reconstruction

Lymph node transplant is surgery in which lymph nodes are moved from one part of the body (usually the abdomen) to the lymphedema affected area. The transplanted lymph node theoretically stimulates the growth of new lymph channels into and out of the transplanted node.
Anastamotic reconstruction attempts to restore lymph flow through a surgical re-joining of the damaged lymph channel either to another lymphatic vessel or to a vein.
Debulking is surgery that involves the surgical removal of excess tissue that hangs in folds.
Liposuction is an excisional operation during which a tube is inserted under the skin. Through this tube, a high-pressure vacuum is applied to break up and "suck out" excess fat cells. This procedure often leaves excess skin hanging loose.
Because most of the observations of outcomes from lymphatic reconstruction for lymphedema are limited in scope and duration of follow-up, these procedures are not actively practiced in our institution. A significant potential for risk exists, including unexpected worsening of the lymphedema, failure to improve the original condition, and scarring complications of the surgical intervention. In lymph node transplantation, there is a finite risk that lymphedema could also develop in the region of the body from which the transplanted lymph node is harvested.

Excisional Surgeries

Debulking is a surgical intervention that removes large excesses of skin and soft tissue overgrowth; which occurs as a complication of longstanding lymphedema
Liposuction is a specialized adaptation of the procedure that permits the surgeon to remove overgrown fatty tissue that resides under the skin. This can become necessary in lymphedema because of the tendency for fatty overgrowth to commonly occur when lymphedema is chronic. In properly selected patients, the lymphedema limb can be restored to normal size through surgery. The operation is performed under general anesthesia, but is minimally invasive. The surgical technique has been perfected in Europe over the past two decades and now has an extensive documentation of efficacy without complications or untoward outcomes.
Both forms of excisional surgery are performed, for properly selected patients, in our center.

Stanford Medicine » Stanford Hospital & Clinics » Cardiovascular Health » Lymphedema

carol57

Kira, I find it sobering that Dr. Rockson is taking such a conservative stance on the two lymphatic reconstruction surgeries.  I wonder if there's a coincidence that he's releasing this commentary at the same time that a surgeon in his backyard is advertising one of these surgeries (see the thread where NatsFan posted that she'd seen an ad while traveling in California, I believe). 

purple32

Good observation, Carol!
Quite disheartening.

Binney4

Carol, I hear you. Or maybe, since he travels widely, Rockson has actually met and discussed these things with Dr. Vignes, the author of the French study citing the results of these surgeries that are so often swept under the carpet when doctors are advertising for patients:

http://www.ncbi.nlm.nih.gov/pubmed/23305787

Since many insurance companies have now caved and are paying for unproven LE surgeries, we're sure seeing a lot more advertising out there. I think what has alarmed me the most is my recent discovery that there is no requirement on the part of the surgeons doing these surgeries to demonstrate either the effectiveness or safety of the procedures, and there's no one looking for the long-term complications, much less making them known. It's all based on an agreement between patient and surgeon, so when I see doctors advertising it sure makes me worry about the protections that are not in place to assure full disclosure of the risks and potential. There are not even any standards regarding who is most likely to benefit from the surgeries and who might be most likely to be further damaged by it. It's all up to each individual surgeon to decide for himself--based on no research and sketchy lymphatic science (and let's face it--a hefty surgery fee). I'd like to think the women undergoing these surgeries are brave pioneers making a cure possible for all of us, but without the research backing up the work, it's a lot more about their vulnerability than anything else. 

FIRST transparency and full disclosure, not to mention actual on-going research of a high quality. THEN we can talk about who are the brave ones willing to give it a try. As it is, we're all at risk, hoping against hope for relief and a cure, and being offered ads instead of studies. 

WE NEED TO STAND UP TOGETHER AND SHOUT WITH ONE VOICE FOR RESPONSIBLE RESEARCH AND REPORTING!!!

Binney, sick of seeing the damage happening to women I care about and not being able to do anything about it

carol57

Binney, it sure would be great if the LE research community applied some pressure on the surgeons to be more transparent and to engage in that research.  It takes surgeons with great skill to do ethical research, and it's incredibly frustrating that these surgeons are so seemingly reluctant to add research to their surgical programs.  Even if 'research' begins simply with more case-study disclosure of outcomes, that would be a good start.

It's easy to see why there's so much enthusiasm for surgical solutions, since the traditional treatments are so unsatisfying and frustrating. The ladies who are posting about surgical successes here in bco and elsewhere have great reason to celebrate.  However, the ones whose surgeries did not work out, or did more damage, are quietly dealing with the aftermath.  I know that both you and I have friendships with women who regret their decisions to try surgery.

LymphActivist

It is interesting that Dr. Rockson does not mention what I believe to be the most common surgical techniques, that of including one or more lymph nodes from the tails of the inguinal area in the transplanted abdominal flap used in the breast reconstruction following breast cancer treatment. Patients that have arm lymphedema as a result of previous breast cancer surgery may also be candidates for Vascularized Lymph Node Transfer in combination with the DIEP flap procedure. This involves the transplantation of healthy lymph nodes from the groin to the underarm area (axilla) to replace the lymph nodes removed or damaged by previous axillary surgery. The procedure helps restore lymphatic drainage of the arm and can significantly improve lymphedema. - See more at: http://prma-enhance.com/breast-reconstruction/diep-flap#sthash.onamwAGu.dpuf

kira66715

Bob,this is a summary for patients and in his textbook, he includes chapters from surgeons who are doing the surgeries.

However, despite clearly knowing about the procedures-- he has webnars all the time about them-- due to the lack of strong evidence to support them, Stanford is not performing them.

Search the literature, there are no large studies with adequate follow up, and zero double blinded randomized clinical trials. 

Surgeons get a free pass from proving efficacy and safety. There have been two excellent studies in the New England journal, double blind, randomized, where patients got sham surgeries for knee arthritis or meniscus tears, neither showed surgery to be of benefit. Yet they're still widely done and paid for.

We all want a cure, and now there's money in it for the surgeons,but zero obligation to prove long term safety or benefit.

Don't doubt for a minute that Rockson is unaware.

Amoc1973

Im always A bit skeptical when certain institutions do not support certain procedures. I've been in medicine for 20 years & what one doc will say concerning a procedure, ie saying it's not necessary, usually is because they don't perform that procedure and vice versa. The number one cancer hospital in the country supports these procedures on CERTAIN patients. I've read about 3 studies published from MD Anderson on the bypass surgery. I was also provided w several more (from other universities, countries). I was also told the surgerywas unnecessary  for me at this time. But we are monitoring in case I have any progression. When you work for a large university/state institution your pay as a surgeon is set....you don't make more money for doing unnecessary surgeries. Private practice is a diff story of course. But I am VERY thankful that insurance providers cannot dictate what my physician deems as necc in my particular case. That is a decision between a pt & their doctor. I was fully informed of the risks & the benefits. Also, if there was a study where someone was given fake/sham surgery then that is disgusting. That IS NOT ethical. First do no harm. You don't PRETEND to do a procedure on someone & expose them to the risk of anesthesia, infection, complications & death. That's hideous. I've never heard of such a thing. Disturbing.

kira66715

Amoc, as Stanley Rockson is very familiar with surgeons who do LE surgery and includes them in his webnars and textbook, but doesn't support the surgery shows me that he has legitimate concerns.

Here is the study in the NEJM, and is is ethical. All studies that involve people have to pass at IRB--and Institutional Review Board, for ethical concerns.

Now, a surgery, is not subject to an IRB. Surgeons can just do them. Back when the LVA wasn't getting reimbursed, as it was considered experimental, Dr. Chang told me it wasn't a cure. Now that it's getting paid for, that seems to have changed.

http://www.ncbi.nlm.nih.gov/pubmed/24369076

Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.

Sihvonen R¹, Paavola M, Malmivaara A, Itälä A, Joukainen A, Nurmi H, Kalske J, Järvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group.

Collaborators (9)

Author information

Abstract

BACKGROUND:

Arthroscopic partial meniscectomy is one of the most common orthopedic procedures, yet rigorous evidence of its efficacy is lacking.

METHODS:

We conducted a multicenter, randomized, double-blind, sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis. Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery.
The primary outcomes were changes in the Lysholm and Western Ontario
Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100,
with lower scores indicating more severe symptoms) and in knee pain
after exercise (rated on a scale from 0 to 10, with 0 denoting no pain)
at 12 months after the procedure.

RESULTS:

In the
intention-to-treat analysis, there were no significant between-group
differences in the change from baseline to 12 months in any primary
outcome. The mean changes (improvements) in the primary outcome measures
were as follows: Lysholm score, 21.7 points in the partial-meniscectomy
group as compared with 23.3 points in the sham-surgery
group (between-group difference, -1.6 points; 95% confidence interval
[CI], -7.2 to 4.0); WOMET score, 24.6 and 27.1 points, respectively
(between-group difference, -2.5 points; 95% CI, -9.2 to 4.1); and score
for knee pain after exercise, 3.1 and 3.3 points, respectively
(between-group difference, -0.1; 95% CI, -0.9 to 0.7). There were no
significant differences between groups in the number of patients who
required subsequent knee surgery (two in the partial-meniscectomy group and five in the sham-surgery group) or serious adverse events (one and zero, respectively).

CONCLUSIONS:

In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure. (Funded by the Sigrid Juselius Foundation and others; ClinicalTrials.gov number, NCT00549172.

And the Study that Binney posted: 

Eur J Vasc Endovasc Surg. 2013 May;45(5):516-20. doi: 10.1016/j.ejvs.2012.11.026. Epub 2013 Jan 8.

Complications of autologous lymph-node transplantation for limb lymphoedema.

Vignes S¹, Blanchard M, Yannoutsos A, Arrault M.

Author information

Abstract

OBJECTIVE:

This study aims to assess potential complications of autologous lymph-node transplantation (ALNT) to treat limb lymphoedema.

DESIGN:

Prospective, observational study.

METHOD:

All
limb-lymphoedema patients, followed up in a single lymphology
department, who decided to undergo ALNT (January 2004-June 2012)
independently of our medical team, were included.

RESULTS:

Among
the 26 patients (22 females, four males) included, 14 had secondary
upper-limb lymphoedema after breast-cancer treatment and seven had
secondary and five primary lower-limb lymphoedema. Median (interquartile
range, IQR) ages at primary lower-limb lymphoedema and secondary
lymphoedema onset were 18.5 (13-30) and 47.4 (35-58) years,
respectively. Median body mass index (BMI) was 25.9 (22.9-29.3) kg m⁻².
For all patients, median pre-surgery
lymphoedema duration was 37 (24-90) months. Thirty-four ALNs were
transplanted into the 26 patients, combined with liposuction in four
lower-limb-lymphoedema patients. Ten (38%) patients developed 15
complications: six, chronic lymphoedema (four upper limb, two lower
limb), defined as ≥2-cm difference versus the contralateral side, in the
limb on the donor lymph-node-site territory, persisting for a median of
40 months post-ALNT; four, post-surgical lymphocoeles; one testicular hydrocoele requiring surgery; and four with persistent donor-site pain. Median (IQR) pre- and post-surgical
lymphoedema volumes, calculated using the formula for a truncated cone,
were, respectively, 1023 (633-1375) ml (median: 3 (1-6) months) and
1058 (666-1506) ml (median: 40 (14-72) months; P = 0.73).

CONCLUSION:

ALNT
may engender severe, chronic complications, particularly persistent
iatrogenic lymphoedema. Further investigations are required to evaluate
and clearly determine its indications.

You know what I consider unethical? Promoting a surgery as curative or beneficial when neither are proven.

Amoc1973

Looks like that study in new England journal was done in Helsinki. That makes a little more sense. I do not believe this type of study would be permitted in the US (thank god), but id have to look into it. Im not sure on that one. I've spoken to Chang & skoracki as fortunately we have mutual friends. Both made it very clear that it is NOT a cure in most cases. They truly want to help pts. They are Both extraordinary physicians with the very best intentions. The fact I was told I didn't need the surgery spoke volumes to me. I have no idea of others motivations, but those guys are cutting edge & ethical. Of course that's my opinion. But I also know about 30 docs & nurses that work with them and I've been told amazing things. I just don't want people to think all physicians are out for themselves. The vast majority really really care. And if you're at a place like MDA....you're top of your field in the country & prob the world.