Innovations in Vascular Care

Podcast Transcript

Announcer:

Welcome to Love Your Heart brought to you by Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute. This podcast will explore disease prevention, testing, medical and surgical treatments, new innovations and more. Enjoy.

Jay Bishop, MD:

My name is Dr. Jay Bishop. I'm a vascular medicine physician and Associate Section Head of the Vascular Medicine Section at the Cleveland Clinic. We have a lot of exciting things going on in the research realm. One of the things that we're studying is abnormal dilations of the aorta, which are abdominal aortic aneurysms. These can be potentially dangerous if the expansion rate is great. As the walls expand, the walls get thinner, and the chances of rupture goes up.

One of the things that we're doing is trying to identify biomarkers that can predict the risk of rupture, predict the risk of expansion and also predict the risk of mortality. We've been involved in several different trials with several different markers. One of them is Glycoprotein VI, GPVI, which has been found as a marker for expansion. The most recent investigation that we're completing right now is GP1B-Alpha, which is another glycoprotein. What we've found so far is that it's not a marker for expansion, but it is a marker that predicts mortality from these abdominal aortic aneurysms. It also predicts the presence of aneurysms.

Another thing we're very proud of at the Cleveland Clinic is our Pulmonary Embolism Response Team (PERT). This is a multidisciplinary team that convenes when patients have blood clots in their lungs from pulmonary embolism, which can be very dangerous. This can affect not only the lungs, but the heart function as well. We have a multidisciplinary meeting, and it may be during the day, or it may be in the middle of the night. But we get together, lots of specialists, including specialists like Dr. Nanjundappa to my left here, for intervention opinions. We do vascular medicine for non-interventional opinions, including anticoagulation. We also have interventional radiology as well.

One of the things that the Pulmonary Embolism Response Team often recommends is mechanical extraction of clots to improve mortality. The literature certainly is evolving, and Dr. Nanjundappa is very involved in this.

Aravinda Nanjundappa, MBBS, MD:

Thank you. I am Aravinda Nanjundappa, one of the interventional cardiologists in the cardiology department and vascular medicine. As Dr. Bishop, my colleague, was mentioning about PERT teams, which are for acute pulmonary embolism, we also have a few of the clinical trials that we're enrolling, and we would encourage our colleagues to refer patients, and also patients to be evaluated.

One of the important trials that we have is called a CLEANER™ PE trial. It's sponsored by a company called Argon. I'm one of the national co-PI (primary investigators) for the trial. Wherein patients with pulmonary embolism, who are at intermediate risk, that means the right side of the heart is dilated, the markers of cardiac, such as the troponin and BMP may be elevated. However, patients should be stable. Such patients, we are evaluating the device called an Argon CLEANER Thrombectomy Catheter to see the safety and efficacy. We will collect the data and then submit it to the FDA for approval.

We are also part of a clinical trial called PEERLESS II. This is sponsored by a company, Inari, wherein we are evaluating the efficacy of thrombectomy versus medical treatment for same patients with intermediate risk PE. People who are stable with pulmonary embolism, but have high-risk features such as right ventricle dilation and cardiac enzymes are being elevated. Such patients are right now treated only with medical treatment, but we are offering thrombectomy as an alternative option.

Another clinical trial for patients with blood clots in the legs, which is DVT, is called DEFIANCE. Here, when patients come with a blood clot, most of us treat them with blood thinners. But we do not know whether thrombectomy is needed for these patients, that means percutaneously to remove the clot. We are evaluating the role of thrombectomy versus medical treatment in this clinical trial called DEFIANCE.

Now, switching gears to hypertension, hypertension is one of the silent killers for patients with cardiovascular disease. It's one of the leading causes of morbidity and mortality because uncontrolled hypertension leads to high mortality, especially in the African American population. We were fortunate to be part of some of the clinical trials for treatment of hypertension using medication by a newer method called renal denervation, wherein we go into the kidney artery with a catheter and cause ablation of the nerves that supply the kidney, so that the input to the brain is reduced to decrease the amount of sympathetic nerves. The sympathetic drive is reduced, and we have better control of blood pressure.

The clinical trial was conducted in combination with interventional cardiology and preventative cardiology with Dr. (Luke) Laffin. We are enrolling a clinical trial for a registry called AFFIRM trial, but we are also in the future looking at renal denervation for both the hepatic artery and the kidney artery in patients with diabetes and hypertension. Dr. Laffin, myself and Dr. Amar Krishnaswamy are going to be involved with this clinical trial. We plan to enroll patients to do ablation of both the hepatic artery and the renal artery. The hope is to treat cardio-metabolic diseases, such as patients with high blood pressure plus diabetes.

Switching gears to another peripheral artery disease subject is patients with below-knee arterial disease with wounds, ulcers in the leg. We call that critical limb ischemia. That means they have significant blockages in the legs, and they do not have enough circulation. That's causing severe pain in the leg, called rest pain, or patients with a wound or an ulcer in the leg. Such patients are defined by patients who have an ankle-brachial index less than .4, and severe occlusal disease of the arteries below the knee. Such patients, if they are untreated, they may end up losing the leg. One of the options is to do a bypass to the lower extremities, which our vascular surgery colleagues, mainly Dr. (Sean) Lyden, Dr. (Lee) Kirksey, are very much involved in doing such procedures.

However, in some patients that are not good candidates for doing the bypass, we can offer to treat them with endovascular. That means going down with the catheters and opening up with the balloons. All the vascular surgeons, and from cardiology, me and Dr. (Christopher) Bajzer, we do perform similar endovascular procedures. We are going to be part of a trial called AcoArt. It's to evaluate the role of Paclitaxel, which is a medication that's used to prevent rejection. It's an antiproliferative drug that is going to be coated on a balloon and using the safety and efficacy of the balloon for below-knee interventions. Such a trial is unique for the fact that Paclitaxel has not been evaluated recently. In the past, when it was evaluated for treating patients with limb ischemia, the trials did not show favorable results. But now, they have a different formulation, a different way of eluting the drug, so we want to see if this can lead to approval of the drug-eluting ballon so that patients will have an option to treat for long-term patency of these arteries so that wounds will heal and save the leg.

These are a few of the trials that we're doing conjointly with all three departments, vascular surgery, interventional cardiology and radiology also.

Jay Bishop, MD:

From a patient standpoint, the Cleveland Clinic is a great destination for many reasons. The first and foremost is that we have so many experts that care for so many different diseases. Not only the common diseases, but the uncommon as well. Oftentimes, you can have appointments on the same day so that you see multiple providers to get the most expert care that you can.

From a professional standpoint, we love to have referrals because we think we take great care of your patient. We really specialize not only in acute care, but longitudinal care. In my specialty of vascular medicine, the joy that I get is through the longitudinal care of the patient throughout their lifespan. To help them navigate the system of healthcare, but also to treat their vascular disease. Many of the treatments for vascular diseases that we have are ongoing and not only prevent blood clots, but they prevent stroke, heart attack and amputation. It's a wonderful destination not only for patients, but for referring physicians because of the abundance of expert care and wonderful resources that we have here.

Aravinda Nanjundappa, MBBS, MD:

I have to echo the words that Dr. Jay Bishop said. There is something in common for both of us. We both have a passion for vascular medicine, and we are also physicians who came from outside the system. I got hired three years ago, and I believe Jay got hired less than five years ago. We can see the stark difference between even a very large private hospital to what Cleveland Clinic is. At the Cleveland Clinic, we have multiple specialties, multiple physicians, with probably the best experts in the world working together. The patient gets the best care.

What I see is that it's very hard for the patient to get harmed here in the clinic. The reason being there are multiple physicians involved, with multiple areas of expertise. Everybody steps in very quickly, very easily to get the opinion, to be seen, doing extra to get the extra care for the patient. Whatever investigations, the sky is the limit. They put everything in front of the patient and get you the best opinion. Whether it's vascular medicine that needs help with Dr. Scott Cameron or Dr. Bishop, it's only a phone call away. Patients can be immediately seen the same day.

Similarly, in vascular surgery, if I have a complex case, I have to put in a call through to Dr. Lyden, the chief of vascular surgery, he immediately has one of the people assigned. Or even if I have a case in the lab, they will come in, scrub in with me and help through the patient. The most important is how to give this patient better care.

Similarly, with interventional cardiology, any help that's needed, it's always available. People are very skilled and put everybody's efforts together. Anesthesia is also very helpful, gets the cases done in a timely manner, and gets the best outcomes. This combined care is very unique. We look forward to referral of patients, we look forward to enrolling in the clinical trials. This is what makes the place a great hospital to work for.

Announcer:

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