Rohit Bhatheja, M.D., FACC, FSCAI, an interventional cardiologist and Medical Director for the Cardiac ICU at Florida Hospital in Orlando, Florida, talks about a new minimally-invasive procedure to treat pulmonary embolism.
Interview conducted by Ivanhoe Broadcast News in August 2016.
I wanted to start by asking about pulmonary embolism, can you describe what is actually happening?
Dr. Bhatheja: Pulmonary embolism is a diagnosis of clots in the lung arteries and it could take various forms. The most common cause of pulmonary embolism is clot either in the leg veins or in the arm veins that would travel to the lung arteries through the circulation in the belly veins and through the heart and lodge in the lung arteries ultimately causing pressure build up in the heart and thus affecting their entire cardiac and vascular system and breathing of the body.
How quickly could something like this happen and how dangerous is this for a patient?
Dr. Bhatheja: That’s a real good question because we see this diagnosis not only as an inpatient but also see this diagnosis although rarely as an outpatient. The most common symptom although and the most concerning are patients with shortness of breath and a new onset of chest pain or dizziness and immense fatigue. Specifically in certain situations like a recent prolonged travel like an airline flight or maybe a cruise or maybe recovery from a recent surgery that are all potential risk factors for both deep thrombosis which is clotting in the leg veins and also pulmonary embolism.
Are there any particular conditions or situations that put people at higher risk? Is it genetic, is it dietary and life style?
Dr. Bhatheja: That’s a very big question but to summarize patients who had any recent travel, prolonged immobility especially after surgery are high risk. Patients who are more than sixty five and who smoke or who are even less than sixty five who smoke but have a sedentary job they’re increased risk. In fact we have seen increased incidents of very young women. In fact I treated a young lady as young as forty years of age whose only risk factors were she was on hormonal supplements for irregular periods and that increased the clotting severity in the body causing her to have blood clots which were massive. Also diagnosis of cancer, overweight, all contributes to towards increased clotting in the body.
What’s the standard treatment for this condition?
Dr. Bhatheja: So for patients who are otherwise stable who have symptoms but they’re blood pressure is okay and they’re breathing okay requiring only a little bit of oxygen which we call low risk patients we usually treat them with blood thinners which are either injectables and or oral and keep them in the hospital for one to five days depending on the severity. Then treat them with blood thinners for three months, six months or twelve months based on the cause for pulmonary embolism. On the other spectrum are the patients that I usually deal with most commonly which are much sicker. They usually come to the emergency room and they have clots which are usually large affecting the heart causing pressure on the heart and they require more emergent care in terms of interventions.
When you’re talking about emergency surgical intervention prior to the FlowTriever what would that intervention be?
Dr. Bhatheja: Pulmonary embolism in fact has been a very difficult disease to study in cardiovascular and pulmonary research. The reason is the mortality for these patients is extremely high and all these patient clinical study have been extremely difficult. If you go back for the past twenty years the mortality is as low as we call twenty to twenty five percent to as high as sixty five percent, that means sixty five to a hundred patients would not live through the diagnosis because they have massive amount of clot affecting the body. Before we started the pulmonary embolism interventional program over here the standard of care really was IV anticoagulation drugs which is basically heparin or heparin like drugs and then start them on oral blood thinners and hopefully they will improve. If the patient is an extremist which is the patient is really not doing good which people sometimes do give is an IV blood clot busting medication. The problem with that is it is a one dose for all so whether you are sixty pounds or six hundred pounds that dose doesn’t differentiate. It doesn’t know that the clot is in the lungs, it can go to the brain, to the belly or to the heart and cause bleeding anywhere. There is a serious risk of major catastrophic bleeding all over. People are trying to shy away from those drugs because those are heavy duty drugs. The third option is major cardiac surgery so basically we cut open the chest and remove the clots. All this surgery is done in good hands, has a good outcome but of course it’s a major surgery.
Talk to me about the new option, the FlowTriever. What is it and how does it work?
Dr. Bhatheja: FlowTriever is what we call in medical terms percutaneous interventional device which basically means we are not doing any major surgery, we are not cutting open any skin, we’re doing everything through needle holes and punctures through the groin. It’s a reasonably big tube, the size and thickness of maybe the pen that one has to write. We go from the groin veins all the way from the belly veins through the heart in to the lung arteries and we access the location and amount of clot. FlowTriever is a mechanical sort of say a mesh suction device. It’s got two components to it, one is the medical mesh which is like three discs together which is released in the clot and it’s got a special manual suction device in which I control the suction amount and the intensity. At the same time I’m trying to pull the clot out that would have encased in to that mesh device, I’m also sucking the clot out. Then the intent is to remove most of the clot in the major arteries of the heart in the lung arteries.
How long does the procedure take for the most part?
Dr. Bhatheja: Right. The procedure of removing the clot takes about forty five minutes to about one hour thirty minutes depending on how much the clot and the location of the clot. From the time we set up to finish requires about two, two and a half hours procedure.
What does the hospital stay for a patient as opposed to the major surgery that was an option?
Dr. Bhatheja: That’s a great question because the reason I got involved in pulmonary embolism invasive management without surgery was because my goal was to get the patients better quickly prevent long ICU stays and get them home soon. This device provides what I call instant gratification. We are able to remove the clot, locate the clot, lay it on the table, and take a picture right in the Cath lab to make sure the flow in the lung is better. We remove the tube right in the procedures room, put a small stitch in and the patients just spends a few more hours in the ICU and then stays for two to three days and then go home.
What is the recovery like?
Dr. Bhatheja: Patients just usually take bed rest for eight to twelve hours after the procedure, the next day they are walking up and about.
What are some of the risks of this procedure?
Dr. Bhatheja: As in any cardiac procedure there are risks involved. The risks are minimal but could be serious. We take this very seriously. This could be as minor as bleeding and bruising around the groin site where we actually put the tubes in. Or it could be more complex like major bleeding requiring transfusion, arrhythmia in the heart because the device can irritate the heart muscle. There could be low blood pressure even during the procedure or outside beyond the procedure time. Also there is a perceived risk why is it perceived, because this hasn’t happened yet but often making holes through the heart causing bleeding around the heart and trying to fix that in the procedure labs. These are all risks that one has to take basically for any major cardiac procedures.
Is there anyone for whom this is not a good procedure?
Dr. Bhatheja: Yes. Patients who have either had long standing pulmonary embolism, which would be a lot of patients that some of my lung partners do see which have pulmonary hypertension and they have clots in the lung arteries for many years. Or have it in the small branches of the lung arteries.
Can you talk to me a little bit about Martha?
Dr. Bhatheja: Yes. Martha she was our initial first case and she was kind enough to consent for the clinical research. She didn’t even ask me much, I told her you have got to listen to me. All the family members I think went through clinical research so we do appreciate her confidence in our clinical research. Martha’s story was unique actually. When she came in she came with the diagnosis of massive pulmonary embolism and she fell down and fractured her facial bones. Unfortunately she was not even a candidate for blood thinners and she was having bleeding issues when I saw her. We stabilized her medically by giving her medications in the ICU and got all the consultants on board and stabilized her from bleeding issue. I thought it was a unique opportunity for us to offer Martha this device which I think was best suited for her clots. Because we couldn’t give her blood thinners, we couldn’t give her clot busting drugs and she just had a major facial fracture. That’s the device we used in her.
You’ve done this on more than a dozen patients now, can you tell me what your sense is, I know it’s early for studies to talk about what kind of success rate. But just antidotally from what you’re seeing is this someday the gold standard, is this the way that your field is going in terms of treating pulmonary embolism?
Dr. Bhatheja: One thing we did not talk about, before using what we call suction devices for clots we have been through phases of putting the clot busting drugs right in to the lung arteries itself. We were very involved in those clinical trials as well, they were very successful. But each device has advantages and disadvantages. The problem with the previous, which I call the previous generation because every few years science changes, is that in you’re using still heavy duty clot busting drugs with major catastrophic complications that can still happen in about ten percent of the patients. My sense is that if this device is used in the right patient which is the right patient selection and the right clot location this device is going to cause major change in the way we treat a patient with acute pulmonary embolism. We are seeing significant improvement not only in the flow in the lung arteries but also significant improvement in the total clot burden. I think we just did a first follow up of a clinical FDA study on this patient for about a month after and the patient is also doing great. That’s the key about what right patient selection is probably the key for a good success.
Is there anything I didn’t ask you that would be important for people to know about this?
Dr. Bhatheja: What people should know that even if you don’t have risk factors pulmonary embolism or deep vein thrombosis can affect anyone of us. You have to be vigilant if you are at risk, the kind of risk factors we talked about. If you are taking international flights and going for flights more than three hours or if your job involves sedentary work it is very important to keep yourself hydrated, keep your calf muscles exercised while sitting, because those are two or three common things that would prevent clotting. And of course second hand smoke is also bad so staying away from smoking is a good thing to avoid.
END OF INTERVIEW
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