VTE prevention in surgical settings: A top priority in clinicians checklist. Episode 3 - Dr. Abhay Bhave and Prof. Juan Arcelus

This podcast focus on: 
•    Thromboprophylaxis recommendations for patients undergoing: 

  1. General abdominal and pelvic surgeries
  2. Cancer surgeries
  3. Bariatric and non-bariatric surgeries among obese patients
  4. Gynaecological, neurological and orthopaedic surgeries

•    Role and recommendation for DOACs as thromboprophylaxis in patients undergoing surgery

Time stamp

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Transcription

00:06 - 00:41

Unknown

Welcome to VTE Unplugged, a brand new podcast series curated by Sanofi. The aim of VTE unplugged is to bring latest in the field of venous thromboembolism management delivered by renowned experts in this field. Today, let's listen to our ongoing discussion on VTE prevention in surgical settings, a top priority in clinician's checklist. In the previous episode, we exchanged information on incidents of VTE among laparoscopic and open surgery, and also heard the expert views around mechanical and pharmacological VTE prophylaxis. Now we will take this discussion forward.

00:46 - 01:01

Dr. Abhay Bhave

Now, if you take say general abdominal surgeries or pelvic surgeries, which are non-oncology surgeries, then would your thromboprophylaxis recommendations differ or you stick to the same one based on say a Caprini Score?

01:02 - 02:12

Professor Juan Arcelus

Yeah. In a benign condition surgery. I think the evidence we have goes to estimate the reason the Caprini Score would be a very good compromise between the patient and the operation risk. So, of course exclude any bleeding potential based on the ACCP table. And once you have a patient at moderate or high risk for VTE without an increased risk for bleeding use molecular weight heparinat least 7, 10 days, please do not use prophylaxis until discharged, when the discharge is before one week, otherwise you are not covering the patient for the period at risk. In some non-cancer surgeries, such as inflammatory bowel disease or obese patients, bariatric or not. You could consider the extension of prophylaxis at least 14, 28, 21 days from the day of surgery, but this is based on smaller studies. So, that would be the recommendation for benign process surgery.

02:13 - 02:27

Dr. Abhay Bhave

Right. Thank you. And if it was cancer associated surgery, then what would be your thoughts in terms of the drug that you would use the dosage or its duration of thromboprophylaxis?

02:27 - 04:03

Professor Juan Arcelus

Well, I think here we can summarize very briefly what we have been commenting so far. Cancer surgery is a high risk recitation, particularly abdominal pelvic. So high risk doses of low molecular weight heparin provided that there are not contraindications. In the case of enoxaparin 40 milligrams, bemiparin 3,500,dalteparin 5,000. If the patient is morbidly obese, has a BMI over 40 consider increasing the dose.

 

In my personal experience and based on research and based on evidence start if possible the night before, it doesn't mean that the patient has to be admitted. We can, we give in my hospital the injection when they, he comes to thelast preoperative anesthesia checkup and they inject at home. Actually it's interesting to mention here that try to avoid injection in the abdomen, if you're going to do abdominal surgery, you can use the back of the five for the preoperative doseas mentioned. In abdominal and pelvic cancer surgery, either laparoscopic or open extended prophylaxis 30 days, other operations like lung surgery, neck surgery. Well, we have neurosurgery, we have emerging evidence that risk also persist for several weeks and probably an extension would be also be welcomed in that other locations of the cancer.

04:05 - 04:14

Dr. Abhay Bhave

Thank you,Professor. So, you are saying that the site of the malignancy also matters and we might want to use a different kind of thromboprophylaxis schedule?

04:15 - 05:35

Professor Juan Arcelus

Well, yeah, you know, most, the vast majority of the studies addressing therisk of VTE in the natural history of VTE are based on abdominal pelvic cancer, you know, gastrointestinal, gastric, colorectal, liver, pancreas,gynae, urology. So gynae and urologymany guidelines put them under the same basket as general surgery, they are very similar. Neurosurgery is a completely different story. Thoracic surgery has peculiarities, but I think from a practical perspective, 80% of the cancer surgeries, most of us conduct perform would be covered by the message I gave before. Probably neurosurgery has these peculiarities with hemostasis, with the consequences of the slightestbleeding. And yeah, wehave data from (inaudible) showing that the nature of history of gynecological patients is different from hepatobiliary or from colorectal. So yeah, but we need further studies to try to provide more specific recommendations. For the time being, I think we can put most cancers under the same umbrella.

05:36 - 05:54

Dr. Abhay Bhave

Right. Thank you very much for that. But many of our patients are a little bit reticent about injectable anticoagulation. So, what's your take on DOACs as a form of thromboprophylaxis in patients undergoing surgery, whether it's malignant or non-malignant?

05:55 - 09:55

Professor Juan Arcelus

Well, DOACs, I think I started going to meetings with colleagues about DOACs. I think it was 2007, something like that. So, that's why we don't call them DOACs anymore. They're not new. They have 14 years. So, when they came, they were nice hope, you know, we have an oral agent, we don't need to monitor, it interferes with fewer drugs than vitamin K antagonist. So, the studies were done in major orthopedic surgery, good results equivalent to enoxaparin, better than enoxaparin for efficacy for rivaroxaban, but worse for bleeding or some issues with the rivaroxaban story. So, what's the real situation today in my setting in most European countries, in the UK, I think that even many orthopedic surgeons have returned to low molecular weight heparin, in my hospital they don't use, some of them at the time of discharge, they could shift from low molecular weight heparin dabigatran or rivaroxaban.

 

So, I know in the UK there was an issue. I know you're a good friend of your, your compatriot, he is also from India. Dr. Arun Rupen (ph), and he told me that in the UK, the initial enthusiasm for DOACs have really subsided. But let's talk about scienceGuntupalli (ph) from Denver has run one interesting study in gynae cancer ladies, 400 ladies, one month of apixaban versus one month of enoxaparin, the group with apixaban actually were receiving unfractionated heparin for at least 24 hours plus mechanical methods. So,the methodology was a little bit north American, you know, the typical US study with a lot of background noise, but anyway, what was the conclusion of the study where one-month follow-up? Well, the rate of VTE was the same. The rate of bleeding was the same. The rate of patient compliance was the same over 85% of the patients complied perfectly both with the injections and with the pills.

 

I have data from the ether study that we ran with Professor Berkeley, 4,000 European major orthopedic patients in Europe with one-month patient diary follow-up the compliance with injectable was 87%. So,I was very happy to see that 85% in one paper published a few months ago. So, I think at the time being the DOACs do not have a role for non-orthopedic surgery. You know, I wouldn't like to have a patient in the early postoperative period taking a DOAC with a compromise absurd bypass. There is a reduction in the absorption of rivaroxaban, by the way something that's probably some of, you know, but I guess the majority don't, aspirin is absorbed in the stomach. If you have a patient with a gastrectomy with a gastric bypass, be careful because the aspirin you give to the patient is not going to be absorbed. But anyway, it's not the DOAC, but it’s an oral becoming very popular in the US in major orthopedic surgery. So, as I said, I think low molecular weight heparins for the hospital stay are a must today. If you want to consider, that would be of label at the time of discharge, shift to DOACs is up to you, but they are not approved and the guidelines do not recommend them.

09:55 - 10:22

Dr. Abhay Bhave

Thank you very much for those points for our practice. I think they're very practical and very needed for us to think in an appropriate manner, you did allude to bariatric surgery. So, my next question will be directed from that point of view that do you perceive these patients who are undergoing bariatric surgery as higher risks for VTE? You mentioned this earlier. So, if the risk is higher, do I need to change my plan on thromboprophylaxis?

10:23 - 14:57

Professor Juan Arcelus

Indeed, indeed obese patients have a very high risk for several reasons. You know, they have an associated hypercoagulability, you know, the abdominal fat releases, some pro-inflammatory molecules. So, it's a very complex, they don't ambulate the same. They have chronic venous insufficiency. So yeah, it's a high risk.Actually the international registry on metabolic and bariatric surgery when they had 35,000 patients in the first month of surgery, the main cause of death was fatal PE well ahead of sepsis, well ahead of cardio respiratory problems, PE was the main killer. So,since then there are cohort studies. We don't have good trials with fondaparinux. There is surprisingly very interesting, very interesting trial showing the efficacy versus placebo, but you know, theconsensus today based on the limited experience, is of course you need to use pharmacological prophylaxis. You can consider adding mechanical methods.This is a good, this is a, surgery is a good candidate for the combination of methods regarding dosing, of course, they tend to need higher doses. How do you adjust by weight, total weight by lean body weight? There are, there are some formula to calculate by BMI as many guidelines recommend, or even in some cases you conduct anti-Xa levels to try to get a peak level between 0.2 0.5 anti-Xa units. I can give you easy rule of thumb that I learned from my good friend, the anesthesiology is from, from Paris Doctor Nadia Rosenthal, by the way, she was original from Egypt. If you already are seeing enoxaparin and I don't want to talk of bariatric surgery, I want to talk off obese patients. I don't care if they're obese patient is undergoing a gastric bypass or gastric tube to relation, or it's undergoing a colon resection or hiatal hernia repair.I mean, the obesity has which by itself. And the other thing is major surgery. So, I was very glad when I took part of the European Society of Anesthesiology Guidelines that we included a section first time ever it was four years ago, that the guideline hit the section on non-bariatric surgery in obese patients. They have a problem as well. So, this is rather easy to some degree. If the patient undergoing major surgery with a high Caprini Score has a BMI between 30/44, if you are going to use 30 milligrams BID, that would be great. What can you do if you don't have the 30 milligram syringe, you can train your nurses to the scar (ph), the scar 25% of the syringe. That's not that complicated. The typical morbid obese patients, BMI 40 to 50, 40 milligrams twice a day, extreme weight, super obese patients, (inaudible) obese, BMI over 50, you can use 60 milligrams twice a day with a very good safety profile. What I don't like very much in the national guidelines in Spain that I took part. I didn't agree with that. You still recommend 60 milligrams or 80 milligrams once a day. I don't like in the early postoperative period, getting that high peak for 12 hours and then having a very long trial without any activity for another 12 hours. And that's what the apixaban model there for the dosing by the way, twice a day, peak draft (ph), peak draft, not so extreme. When you give once a day, as I said, you go beat above the probably safety peak level, and then you spend several hours with that patient under the draft efficacy level. So, I always recommend, and that's a typical US approach using 40 milligrams twice a day or 60 milligrams twice a day.

14:58 - 15:37

Dr. Abhay Bhave

Thank you very much for that Professor Arcelus because as you know, in India, obesity is an issue and you quite clearly pointed out that obese patients may undergo surgery is not only for bariatric surgery purposes, but for other reasons, and we have to be careful. So, I think those pointers are very important for us in practice. In your earlier discussion, you have also told us about certain groups of patients which are gynae and neuro, ortho. Is there anything you'd like to add, especially about say neurosurgical procedures, especially in terms of thromboprophylaxis?

15:37 - 16:58

Professor Juan Arcelus

Yeah, very briefly major orthopedic surgery in Europe, people, we are using low molecular weight heparing in the Northern countries, particularly Germany, Denmark, some major orthopedic surgeons are very happy with DOACs. That's okay. In Japan (inaudible) popular. With aspirin, I have a problem because, you know, I think the evidence behind aspirin is large, large, large distance, much lower than with low molecular weight heparin. So, although the guidelines in the US now go for aspirin. I'm not that happy with that. I don't think the evidence is so strong. Anyway, other orthopedic procedures should be considered based on the Caprini Score because so-called less, you know, a tibial fracture, ankle fracture, sprains. Those are high risk situations. As I said before, gynaeo and urology, you do the same and again, near a surgery, you must be very careful with the dosing. You must be very careful with the timing. So, I don't think it starting preoperatively or in close proximity to surgery would be a good idea, but in this scenario, IPC would be great in the operative room, in the operation room and also in the early postoperative period.

16:58 - 17:01

Dr. Abhay Bhave

Thank you very much, Professor Arcelus.

17:07 - 17:16

Professor Juan Arcelus

Thank you for joining us today. Watch out this space as we bring to you next part of the ongoing discussion between Professor Juan Arcelus and Dr. Abhay Bhave.

 

MAT-IN-2103096-1.0-08/2021