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24 May 2011

Repair Works

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Cleveland Clinic’s Lars Svensson tells EHM about the new techniques and technologies being used to improve outcomes in cardiac surgery

Restrictive lung disease occurs in 70% of people with MFS
Restrictive lung disease occurs in 70% of people with MFS
“One of the biggest improvements in genetic screening in families of those with Marfan Syndrome has been the production of looking at a patient's genes”
-Lars Svensson of Cleveland Clinic

The mission of the Aorta Center, Marfan Syndrome Clinic and Connective Tissue Disorder Clinic at Cleveland Clinic is to bring together a multi-disciplinary team of cardiology, cardiac surgery, radiology and vascular doctors and other cardiology experts to carry out a thorough evaluation of patients using state-of-the-art diagnostic testing, as well as to provide ongoing comprehensive care, genetic screening for families of those with genetic disorders such as Marfan Syndrome, and ongoing research and education to provide patients with high quality and innovative therapies.

Lars Svensson, Director of the center, outlines the role that evolving technology has played in bringing this high quality care to patients: "We increasingly rely on very sophisticated computerized tomography scanning. There has been a huge boom in coronary arteries CTA, and we've also been doing a lot of research on looking at the aortic valve with CT. We do this for all our patients for whom we're planning aortic valve repairs or bicuspid valve repairs, and it gives us a lot of information about the function of leaflets.

"For the patients in whom we're inserting percutaneous valves, which is a completely new technology, we are also looking at the valve very carefully prior to inserting those devices. In some patients, based on the CT studies of the aortic root, this enables us to say whether this is a suitable patient for a percutaneous valve or not."

According to Svensson, the field of endovascular aortic procedures has grown tremendously, and the center now uses these procedures for every patient. "We also, as part of that, are able to create computer models of the branch arteries leading from the aorta; for example, the great arch or the abdominal visceral arteries. That's important because with the new endovascular grafts, we can now have specialized endografts built that fit exactly into those arteries, based on the center line of flow models. We can have these new specialized grafts built with side grafts so it's much easier to put them into patients."

Once these studies have been done, both for the percutaneous valves and for the thoraco-abdominal grafts, the center's surgeons can see exactly which angles are going to be best for fluoroscopic examination of the aortic valve or the visceral vessels. This saves the patients a lot of dye load and cuts down on radiation exposure, because the settings and angles can be determined beforehand.

 "The challenge has been to keep up with the technologies," Svensson says. "Over the last year, we've been building what we call our hybrid operating rooms - choosing the best possible equipment and setup for that. We're currently putting together the final parts of two hybrid ORs, and we have space for another four, for a total of six. We see cardiovascular medicine being done increasingly percutaneously in the future, which is why we're preparing this now.

"There will be cases where we'll want to combine procedures. For example, we might do a robotic left anterior mammary artery bypass to the left anterior descending and then do the percutaneous valve. The operating rooms are built so that we can do both open and fluoroscopic-based percutaneous procedures at the same time."

Innovative therapies

Patients with diseases of the aorta, connective tissue disorder and Marfan syndrome are an important subgroup served by the center. "We're doing most of the mitral valve repairs now with a robot," Svensson says. "We do a lot of aortic valve repairs, for which we use minimally invasive incisions. We also have a big practice of patients who have connective tissue disorders like Marfan syndrome, Loeys-Dietz Syndrome and Ehlers-Danlos.

"In terms of new developments in this sphere, we have now more blood tests we can use to screen patients for connective tissue disorders. We have specific mutations we can detect in patients, for example, with Loeys-Dietz Syndrome, which helps us in their management. There's also a big push to do more aortic research and connective tissue disorders research. I sit on National Heart and Lung Committees, subcommittees of the NIH, looking at aortic disease research and specifically looking at connective tissue disorders. We're overseeing a prospective randomized trial that's investigating a drug called Losartan as a method to prevent growth of the aorta in patients with Marfan syndrome. We should have the results from that in a couple of years' time."

Svensson explains that one of the biggest improvements in genetic screening in families of those with Marfan syndrome has been the production of rapid methods of looking at a patient's genes. "We now have automated devices that work very rapidly to search for mutations, and templates to compare them with, and as part of that, we now have blood tests we can use in patients who have these kinds of tissue disorders.

"We still use some of the older methods, for example, with Ehlers-Danlos patients. We still rely on tissue cultures from the skin, but increasingly we're going to see the genetic information coming from the blood rather than a biopsy, whether it's from the aorta or from the skin."

Aortic repair

Aortic valve repair has been tried for a long time, particularly for the tricuspid valves and the bicuspid aortic valves, but Svensson points out that success rates in the early periods in the 1960s weren't very good, and so it was largely abandoned. "Then Tirone David from Toronto came up with a technique for managing a tricuspid aortic valve in a patient with a dilated root. The operative technique was fairly complicated with a lot of scientific formulas, and it therefore wasn't very applicable.

"What I did was modify that and reduce the aortic roots, aortic valve annulus and sino-tubular junction to what one would expect in a normal patient based on postmortem studies. We use a nomogram based on a patient's body surface area to repair the valve, repair the valve leaflets, reduce aortic root size, and create a neosino-tubular junction that is normal for a patient of that body surface area.

"We've done just over 210 of these, and our success rate after nine years is 96% freedom from re-operation. What that means is that 4% of our patients, 1 in 25, has needed a repeat operation within nine years, and at least two of those patients had endocarditis. Infection is still a potential problem, but when you consider that these are young patients - I operated on one patient this week who was 22 years old, and another one who was 15 - you don't want them to be on warfarin with a mechanical valve if you can avoid it. "We do these repairs and the patients have a lower risk of stroke and a long-term lower risk of infection, and they don't have to deal with issues of being on an anticoagulation."

Svensson's team can repair about 90% of tricuspid aortic valves and 80% of leaky bicuspids valves; those they can't repair often have leaflets that have been distorted by calcium. For those patients with bicuspid valves, the results aren't quite as good as the tricuspid valves. In the most recent analysis, the center had a 90% freedom from re-operation in 10 years. Svensson points out that this is also a young patient population, and if this procedure keeps them from needing a mechanical valve or being on warfarin, this is very worthwhile.

Research projects

The recent retrospective studies Svensson has been involved in have focused on showing the benefits of min-invasive mitral valve repair versus a standard sternotomy. Patients with minimal invasive surgery require fewer blood transfusions and recover quicker. In his prospective studies, he's looking at brain protection, and in particular at patients who have complex arch aneurysms and the entire aortic arch has to be replaced.

"We've been randomizing the patients to either antegrade or retrograde brain diffusion; antegrade being via the carotids and retrograde being via the jugular vein. We then do preoperative and post-operative neurocognitive function - essentially memory tests and IQ tests. We're hoping to complete that study towards the end of the year. We know that our stroke rate is very low, but what we don't know is what the neurocognitive function is like after these operations, so the results of that study will be very interesting.

"Another area of prospective study that I'm working with is the percutaneous aortic valve. I'm on the Edwards Executive Committee running the PARTNER trial, which is a randomized trial between open surgery versus percutaneous aortic valves either put in through the femoral artery or through a mini-thoracotomy in high-risk surgical patients. Patients have to have an estimated risk of death of more than 15% to be in the study.

"Another part of the prospective study I'm working on is looking at Group B patients - patients who are inoperable by conventional means. Those patients are randomized either to the best medical treatment or to a transfemoral percutaneous aortic valve. We've now randomized 400 patients. The aim is to present the results to the FDA for approval of the device in the United States. In Europe, the device has a CE mark, so it's already available.

"My other area of interest is percutaneous mitral valve procedures. We have a new device that we've used in 60 animal studies, and we're now trying it out in patients. It's what we call a spacer that is put in either through the femoral vein or potentially through a small chest incision into the mitral valve. We're still doing the research, but it looks promising as far as treating patients who have mitral valve regurgitation and are not otherwise candidates for surgery, and we will aim to help patients who are inoperable by any other conventional means."

General outlook

Svensson says there has recently been a drop in the incidence of heart disease, which is most likely related to better use of antihypertensives, better control of heart failure, and the introduction of the cholesterol statin. However, recent data suggests this decline in heart disease in the US may be slowing, particularly in women.

"The other undeniable fact is that the deaths have been reduced by greater and more rapid intervention in patients with acute myocardial infarction and stroke," Svensson says. "We're working to reduce what we call 'door to balloon' time - the time from a patient showing up in the emergency department to getting them to the cath lab to open up the coronary arteries as quickly as possible; and in the case of strokes, re-perfusing them. We're putting a lot of effort into doing that, but in addition, we also have a big campaign to get emergency departments to be quicker at calling us and having us send out our helicopters to pick up patients.

"When I was doing cardiology many years ago, we talked about a 20 to 30% mortality rate for acute myocardial infarction, and now in some areas - for example, the northwestern states - they have been able to reduce their mortality rate for acute myocardial infarction to about 10%. There is some variation across the country in the mortality rates, which is why there's a big push to rank hospitals, and one of the ways this is done is through their mortality for acute MIs and also the speed at which patients' coronary arteries are opened up.

"The big picture is that there has been a reduction in the incidence of cardiovascular disease. There are many reasons for that; clearly the biggest group of patients are the coronary artery disease patients, and we have new options for those patients in both prevention and treatment after acute events, which has resulted in better outcomes. There is a debate around the cost in making this available to everybody, but that's for the politicians to deal with."

Svensson believes that the cost of healthcare will be one of the major issues facing Congress and the new President, especially the unfunded costs of Medicare. "It's been calculated that in the next 75 years, Medicare will cost the US taxpayer $35 trillion. That's obviously a rough calculation, but it shows the magnitude of the problem. That's why politicians must address the issue of how to reduce the cost of healthcare in this country."

No easy answer

"There isn't one easy, quick answer to how to do this, Svensson explains. "The likelihood is we're going to see some saving in costs from IT. There clearly is benefit to having patients on electronic records and not having to duplicate testing. Martin Harris, who is head of our IT department, is part of a national committee that is setting the standard for communication of healthcare data and medical records between institutions.

"This will be a privately run organization with the big insurance companies such as, for example, Kaiser, the big healthcare groups or plans like Partners in Boston and Cleveland Clinic healthcare systems, and input from the big IT companies, including Google and Microsoft. Those companies will all be part of setting a standard for healthcare transfer information. This should cut the cost of testing and having a common record, and the flow of information will cut down on unnecessary testing and waste in the system."

Svensson points out that an increase in preventative medicine should also help to bring costs down. "Preventative care for cardiovascular disease has been very effective, and I suspect with time, we will see people having different types of healthcare plans based on their underlying disease. For example, if you've got diabetes, you'll probably lean towards a healthcare plan that caters more to wellness for diabetics. Or if you have liver disease, you might choose a plan that has an option for liver transplantation. Obviously there's always the problem of adverse selection, but I think we're going to have to see more cost containment within the healthcare system.

"In terms of what's going to happen with healthcare practice in the United States and how it's delivered, the days of the private practitioner - whether it be an individual practicing as general practitioner or family doctor, or an independent functioning cardiac surgery group at the other extreme - those days are numbered. The healthcare situation is becoming so complicated, and no single person can manage all of that, and increasingly we're going to see physicians working for big healthcare systems and in all likelihood being on salaries with various types of incentives. That will make it easier to organize the healthcare system and regulate it.

"Here at Cleveland Clinic, we are structuring our system into silos of institutes dealing with diseases. For example, we have our heart and vascular institute, where everybody deals basically with the same problem to some degree, and we talk a lot to each other, and which makes communication a lot easier, and improves patient care. We will see an increase in that type of grouping of diseases into what is called institutes or centers to deal with those problems and physicians working more closely and communicating about patients and offering patients the best possible care." 

Lars Svensson is an attending surgeon and Director of the Center for Aortic Surgery and Director of the Marfan Syndrome and Connective Tissue Disorder Clinic in the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic.

Svensson is board-certified in general, vascular, thoracic and cardiac surgery. He specializes in adult cardiac surgery; cardio-aortic and aortic surgery; minimally invasive mitral and aortic valve surgery; mitral and aortic valve repair operations; Marfan syndrome; peripheral vascular surgery; percutaneous valve surgery; and the Maze procedure.

He was born in Barberton, South Africa. He received his training in cardiology and in general surgery at the Johannesburg Hospital and his training in cardiothoracic surgery at Baylor College of Medicine and the Cleveland Clinic Foundation, for which he received a fellowship.

In 2005, Dr. Svensson was named King James IV Professor of Surgery of the Royal College of Surgeons of Edinburgh.

---EXTRA INFO---

Cleveland Clinic Heart & Vascular Institute

The Heart & Vascular Institute at Cleveland Clinic is composed of more than 130 physicians within cardiovascular medicine, cardiothoracic surgery and vascular surgery. In October 2008, the institute moved to the newly constructed Sydell and Arnold Miller Family Pavilion. This facility will house more than 2000 employees in nearly one million square feet dedicated to treating cardiovascular disease.

Overview 2007

Total patient visits 294,022
Total new patients 8322
Admissions (acute and post-acute patients) 16,351
Total beds 369
Coronary intensive care beds 16
Heart failure intensive care beds 8
Thoracic and cardiovascular surgery intensive care beds 67
Cardiology/vascular step-down beds 278


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