Minimally invasive cardiac procedures improving patient outcomes
Many more patients with heart valve disorders have just qualified for procedures that can dramatically improve both the length and quality of their lives.
In December 2020, the American College of Cardiology, together with the American Heart Association, released the long-awaited full revision of the “Guideline for the Management of Patients With Valvular Heart Disease.” The 173-page doctrine was last updated seven years ago.
“It’s a big change in terms of how we deal with valvular heart disease,” said Richard Zelman, MD, FACC, Chief of Interventional/Structural Cardiology at Cape Cod Healthcare. “It recognizes the fact that there’s been so much shift away from open surgical techniques and towards less-invasive, catheter-based techniques for treatment of valvular disease.”
The updated guidelines focus mainly on the three adult heart valve disorders that are most commonly treated at Cape Cod Hospital: the aortic valve, the mitral valve and, to a lesser but increasing extent, the tricuspid valve, he said.
“Before, it was a minute aspect of what was discussed in the guidelines,” he said. “Now, there are approved (minimally invasive) procedures for the aortic valve, with the transcatheter aortic valve replacement (TAVR) being available to all patient groups, and now the MitraClip® procedure being available to many patients who have mitral valve leakage, particularly for patients who aren’t good candidates for surgery.”
Medicare, just this month, approved payment for the MitraClip procedure for patients with secondary mitral valve disease, which is “a very large group of patients,” according to Dr. Zelman.
“Most importantly, the guidelines recognize that, more and more, we have to focus on the patient’s own desires,” he said. “They recognize that, even if there might be some incremental medical benefit of a more invasive operation, often patients will opt for a less-invasive option.”
Two important concepts are stressed throughout the new guidelines:
- The importance of having a multidisciplinary heart valve team working at a Comprehensive (Level 1) Valve Center to perform these procedures.
- The importance of having a shared decision-making team that includes members of the multidisciplinary heart valve team, primary care providers and, most importantly, the patient and his/her family.
Over the past five and a half years, Cape Cod Hospital has assembled all of the interventional/surgical/imaging and institutional requirements to be considered a Comprehensive Valve Center (CVC). The medical team includes interventional cardiologists, cardiac surgeons, electrophysiologists, interventional radiologists, cardiac imaging specialists and advanced practice nurse practitioners and physician assistants. They are part of the Structural Heart Team that works in concert with each other and patients to ensure that the appropriate therapy is offered, Dr. Zelman said.
Outcomes for transcatheter aortic valve implantation (TAVI) at the Cape Cod Hospital CVC are significantly better than the average of all hospitals in the U.S. that report to a national database, according to Dr. Zelman. In a recent letter to Cape Cod Healthcare physicians about the new guidelines, he outlined the outcomes:
- Mortality (30-day post-procedure): CCH – 1.2 percent of patients; National Registry – 1.9 percent
- Stroke (30-day post-procedure): CCH – 0.6 percent; National Registry – 2.0 percent
- Permanent Pacemaker: CCH - 5.4 percent; National Registry – 9.6 percent
- Disabling/Life-Threatening Bleeding: CCH – 0.0 percent; National Registry – 1.9 percent
There are more than 30 different criteria that must be met to become a CVC, such as having full-time surgeons and interventional cardiologists, and performing a certain volume of procedures each year, Dr. Zelman said. It is very unusual for a community health center, like Cape Cod Hospital, to fulfill the criteria to be considered a Comprehensive Valve Center, he added.
“The guidelines say, when patients are seen at a Center of Excellence by a multidisciplinary heart team, they can undergo evaluations for these less-invasive catheter-based procedures that can tremendously affect their symptoms, keeping them out of the hospital and giving them increased abilities to do more without the problems with breathing and other issues, and also extending their life,” Dr. Zelman said.
There are several groups of common types of problems that affect the heart including:
- Coronary Artery Disease, (the major cause of heart attack and cardiovascular death)
- Heart Rhythm Disorders
- Structural Heart Disorders, including valvular heart disease
- Primary disorders of the heart muscle or myocardium
Cape Cod Hospital first began performing a catheter procedure to address narrowing of the aortic valve – the TAVR procedure - five and a half years ago. At that time, it was only approved for use in patients too sick or frail to have open heart surgery. Now, after many large studies have shown that it is comparable in safety and efficacy to open surgical replacement, it has been approved for use in all patient groups. Cape Cod Hospital now performs about 200 TAVRs per year.
Most Important Trial for Valvular Disease in 10 Years
But, much more common than aortic valve problems is a condition where there is significant leakage (insufficiency) of the mitral valve, and the new guidelines offer exciting new options for this large group of patients, Dr. Zelman said.
“The mitral valve is a much more complex valve than the aortic valve, and there is a huge amount of research going on now to try and come forth with more catheter-based technologies. The MitraClip device was initially authorized only for patients who had leakage that was caused by problems with the mitral leaflets themselves, and who were not candidates for surgery,” he said. “Now the MitraClip procedure has been found to be the best option for patients who have mitral valves that have become leaky secondary to damage to the heart muscle itself often due to heart attacks and other problems, who have not responded adequately to medical therapy alone. These patients are often quite limited by their valve condition and this catheter based technology has been shown not only to improve symptoms and exercise capacity but has been demonstrated to reduce the need for hospitalization and improve survival.”
The medical trial that proved the MitraClip device useful for these patients, known as the COAPT Trial, “is probably the most important trial impacting patients with valvular heart disease in the last decade,” he said.
A device similar to the MitraClip is now being studied and reported to have significant benefits for patients with leaky tricuspid valves. These patients have long been recognized to be at high risk for open heart surgery, so “it’s another pretty large group of patients that will probably very soon benefit from catheter-based procedures,” he added.
Despite these advances, many heart valve patients are still better candidates for the open surgical procedure than for catheter-based techniques, according to Dr. Zelman. For instance, younger, low-risk patients, many of whom have congenital abnormalities of the aortic valve, are still often best served with the traditional open surgery. In addition, for those patients who are good surgical candidates with mitral valve disease that primarily affects the leaflets of the valve, surgery is “by far” the better option, because the valve can be expertly repaired with better long-term results, he said.
Another exciting area where catheter-based technology is having a tremendous impact involves the prevention of stroke. A large proportion of strokes occur as a consequence of blood clots that travel to the brain as a result of the common heart rhythm disturbance known as atrial fibrillation. For decades the only way to prevent this was to prescribe powerful blood thinners (anticoagulants).
“Unfortunately, a great many patients turn out to be poor candidates for long term anticoagulation” according to Dr. Zelman. “And of the patients who are prescribed blood thinners, which is unfortunately a relatively small fraction, about half of those patients stop the blood thinners within a year or so.”
Now, structural cardiologists have the ability to place devices in the left atrium, (specifically the left atrial appendage where more than 90 percent of blood clots tend to form), to seal off that area so blood clots cannot form and then travel to the brain.
“This catheter-based procedure is performed currently using the newest generation of the Watchman® device which has been proven in large clinical trials to be highly effective at preventing stroke while not subjecting patients to years of incremental risk of hemorrhage”, said Zelman.
On the horizon in the area of structural heart disease are a number of new devices that are moving through regulatory evaluation for replacing the mitral valve and tricuspid valves (rather than attempting to repair them) with catheter-based techniques, Dr. Zelman said. There are still patients who are not good candidates for catheter-based repair or open heart surgery, which leaves them with few if any options. Dr. Zelman knows that, based on what is now available for aortic valves through the TAVR procedure, similar procedures for the mitral and tricuspid valves will mean the world to these patients.
“From the aortic valve standpoint, we know that once a patient becomes symptomatic with aortic valve narrowing, the majority of these patients are going to be dead within one and a half to two years. And now in just a little over five years we’ve treated 750 patients, many of whom would have had no other options for therapy and would otherwise have succumbed to this disease. Fortunately for them medical technology had advanced to the point where with just an overnight hospitalization they could be cured of an otherwise uniformly fatal disease”,
To find out whether you qualify for any of the catheter-based therapies for structural heart problems, or whether you are a better candidate for an open heart operation, talk to your primary care physician or cardiologist about a referral to the Structural Heart Team at Cape Cod Hospital. Members of the team include:
- Pauline Turley, ACNP
- Kimberly O’Dell, FNP
- Leah Pacheco, PA