Recent Studies Reveal Early Discharge Advantage following Successful Transfemoral TAVR Procedure

Reduced Hospitalization Proves Particularly Beneficial During COVID-19 Era, though Caution Needed for Certain Patient Groups

Two recent studies observing patients undergoing a transfemoral transcatheter aortic valve replacement (TAVR) procedure have reported shorter hospital stays with no adverse impact on outcomes among study patients – a particular benefit in the COVID-19 era.Transcatheter Aortic Valve Replacement

One study, conducted by researchers from Policlnico-Vittorio Emanuele Hospital, University of Catania, Italy and published in EuroIntervention, found that “discharging patients within 24 hours of a transfemoral TAVR procedure performed without complications appears to be a safe approach,” which could have implications for patient care in the COVID-19 era.1

The researchers reported that “there were no differences in rates of mortality or rehospitalization for heart failure through the first year between patients discharged the next day and those who left the hospital later” – noting that ‘patients with a prior permanent pacemaker implant (PPI) were more likely to receive next-day discharge.’

These results support broader efforts for a “minimalist approach” to post-procedure patient care in centers across the United States and abroad. Propelled by the pandemic, new protocols and best practices may emerge as a silver lining in otherwise challenging times.2

Conversely, a study published as a research letter November 9, 2020, in JACC: Cardiovascular Interventions, and presented at the virtual American Heart Association 2020 Scientific Sessions, reported that pacemaker implantation has risen slightly amid length of stay decline – suggesting that ‘the trend toward earlier discharge following TAVR means that some conduction disturbances are not picked up by physicians during the index stay and patients may develop complications outside the hospital.’3

While the percentage of pacemaker implantation procedures have remained within range, the early discharge of transfemoral TAVR patients changes the timing of implantation and readmission rates, as patients who may have required a pacemaker during their initial hospital stay are released, though later return for the procedure.

According to the study’s senior investigator, Anil Gehi MD of the University of North Carolina, “the need for pacemaker implantation has remained the same—it’s still in that 10% range—but what we saw was that there was a shift in the timing of pacemaker implantation.”

“Because patients are being discharged sooner, rather than getting their pacemaker during that initial hospitalization, more and more of them are having to come back for readmission and then getting their pacemaker,” said Gehi.

While researchers and practitioners agree shortened hospital stays can be beneficial to patient recovery, particularly during a pandemic, identifying high-risk patients for continued monitoring is key in shaping new protocols.

View video on the TAVR procedure.

References

  1. Costa G, Barbanti M, Picci A, et al. Predictors and safety of next-day discharge in patients undergoing transfemoral transcatheter aortic valve implantationEuroIntervention. 2020;16:e494-e501.
  2. Wood DA, Sathananthan J. “Minimalist” transcatheter aortic valve implantation during the COVID-19 pandemic: previously optional but now a necessityEuroIntervention. 2020;16:e451-e452.
  3. Mazzella AJ, Hendrickson MJ, Arora S, et al. Shifting trends in timing of pacemaker implantation after transcatheter aortic valve replacementJ Am Coll Cardiol Intv. 2020;Epub ahead of print.

 

Aortic Stenosis and the Role of Catheter Based Therapies

When Less Invasive TAVR is Preferable in the Treatment of this Serious Heart Condition

Aortic valve disease is one of the most encountered structural abnormalities of the heart.  The aortic valve is a trileaflet structure that separates the left ventricle from the aorta. In systole, during left ventricular contraction, the aortic valve opens between 3 -5 cm2 to allow blood flow.

Aortic valve disease is one of the most encountered structural abnormalities of the heart.  The aortic valve is a trileaflet structure that separates the left ventricle from the aorta. In systole, during left ventricular contraction, the aortic valve opens between 3 -5 cm2 to allow blood flow through the aorta and to the rest of the body.

The most common disease of the aortic valve is aortic stenosis. Aortic stenosis is the result of calcification and narrowing of the aortic valve. As a result, the valve does not open adequately in systole, causing strain and pressure overload on the left ventricle. Aortic stenosis is the result of active inflammation of the valve, which in many ways is similar to atherosclerosis.

Risk factors for developing aortic sclerosis include hypertension, high cholesterol, diabetes and chronic kidney disease. There is perhaps also a genetic predisposition to developing aortic stenosis. Aortic stenosis is more prevalent in the older population. It is mostly diagnosed and treated in patients in their 70’s and 80’s. It is estimated that over six percent of the population in the United States over the age of 70 suffer from aortic stenosis. However, aortic stenosis can present earlier if the patient is born with an abnormal valve such as an unicuspid or bicuspid valve. In these instances, symptoms develop earlier in the fifth and sixth decade of life.Healthy Aortic Valve

Symptoms of aortic stenosis include chest pain, shortness of breath and palpitation. If left untreated, it can ultimately cause congestive heart failure and loss of consciousness – and ultimately sudden cardiac death. The three-year prognosis in aortic stenosis is extremely poor once the patient has developed symptoms.

Diagnosis of aortic stenosis hinges on a physical examination and noninvasive diagnostic cardiac testing such as echocardiography.  Severe aortic stenosis results in a harsh systolic murmur heard best on the left sternal border. The second heart sound is also blunted or absent in this area. Echocardiography shows thickening and calcification of the valve with significantly reduced mobility in systole. The ultimate diagnosis is made by measuring pressure gradient across the aortic valve, utilizing Doppler Wave Echocardiography. A mean gradient of over 40 mmhg, or a valve area of less than 1 cm square, strongly predicts severe aortic stenosis.Aortic Valve Assessment

Treatment of aortic stenosis requires active intervention. Medical therapy alone does not resolve the severe narrowing of the valve. Traditionally, patients have required open heart surgery to replace the narrowed valve with either a bioprosthesis or a mechanical valve. This would require a sternotomy and 4-6 weeks of recovery post operation.

Over the past decade, though, a new technique utilizing transcatheter methods has been shown to be either equivalent or superior to surgical replacement in most patients regardless of their surgical risks. During this procedure commonly known as Transcatheter Aortic Valve Replacement (TAVR), a new valve is advanced from the femoral artery in the groin (in most instances) and placed inside the narrowed valve. There is no surgical incision during TAVR, therefore recovery is much faster.Transcatheter Aortic Valve Replacement

 

Patients undergoing TAVR need elaborate work up prior to their procedure. Aortic valve size needs to be determined prior to the procedure, unlike the traditional procedure when the surgeon decides on valve size during the surgery. While most valves are delivered through the femoral arteries, there are instances where femoral arteries are either too small or diseased to accommodate delivery of the valve. In these instances, alternative access should be utilized to deliver the valve.

A gated CT angiography is essential to address sizing and access before the procedure. Cardiac catheterization is also needed to define patency of the coronary arteries before the procedure. Significant coronary artery disease usually needs to be addressed prior to TAVR. There are currently three commercially available TAVR valves. Which valve to use depends on the anatomical and clinical characteristics of each individual patient for optimal outcome.

Finally, TAVR in lieu of surgical aortic valve replacement (SAVR) is determined on a case by case basis. For example, a patient with extensive multivessel coronary artery disease (CAD), who will need coronary bypass surgery, should also have SAVR at the same time. Some patients with bicuspid aortic valve also have ascending aortic dilatation and will need surgical repair of their aorta, which can be done at the time of SAVR.

Lastly, there are patients who can go either route depending on their circumstances. For example, a younger patient with a small aortic valve might undergo TAVR now. But it is conceivable that their TAVR valve will deteriorate over the next decade or two and they will need another procedure. The small size of the aortic valve might prohibit another TAVR procedure down the line. So, this patient might decide to have a TAVR now and reserve SAVR for a later time, or, alternatively, do the reverse depending on the circumstances. That is why it is important that the treatment recommendation is made after input from every member of the valve team, including an interventional cardiologist as well as a cardiac surgeon.

 

A Tale of Two Valves: Why Is Surgery Still the Preferred Treatment for Mitral Valve Disease?

Transcatheter aortic valve replacement (TAVR) has become a mainstream treatment for aortic valve stenosis, a disease that affects the heart’s aortic valve.

As the technique has grown in popularity, many patients are wondering whether similar minimally invasive approaches can be used to treat disease in other heart valves. However, each of the heart’s valves has its own unique anatomy and presents its own unique challenges.

TAVR Takes Over

TAVR was initially approved for patients at high risk of experiencing complications from surgical valve replacement. By 2015, a third of patients being treated for aortic valve stenosis underwent TAVR. And in late 2016, the Food and Drug Administration (FDA) approved TAVR for treating patients at moderate surgical risk after clinical trials showed it was safe and effective for them.

Experts predict the number of patients undergoing TAVR will grow significantly in the next five years, overtaking surgical valve replacement as the most common treatment for aortic valve stenosis.

How We Treat Mitral Valve Disease Today

Now patients and healthcare professionals are wondering: Could the same concept be used to repair other heart valves?

There’s great interest in doing so, especially for treating mitral valve disease – a condition that affects far more patients than aortic valve disease. In fact, experts estimate that several billion dollars have already been spent on research and development of transcatheter therapies for mitral valve disease.

Despite all that activity, though, the only device approved for mitral valve disease so far is the MitraClip. This device has been shown to be somewhat effective in treating mitral regurgitation (backward fow of blood into the heart) in patients with severe disease, who aren’t good surgical candidates.

MitraClip has so far been approved only for treatment of degenerative mitral valve disease, a condition that is the result of pathology of mitral valve itself. Only a mi purity of patients with mitral valve disease have degenarative disease. However, the results of Coapt trial recently presented showed that this device could be as effective in functioitral regurgitation a condition that caused malfunctioning of the mitral valve as a result of dilitation of left ventricule.By far the majority of patients with severe mitral regurgitation have functional disease.

The Mitral Valve’s Tricky Anatomy

While Mitraclip has certainly shown promise in treatment of mitral regurgitation, transcatheter mitral therapies are yet to show similar effectiveness in treatment of mitral valve disease as surgery in all comers. Why is it, then, that transcatheter techniques have been so effective for aortic valves but not for mitral valves? The answer lies in the anatomy and location of these two valves:

  • Shape: The aortic valve is a circular apparatus sitting at the end of a tube. The mitral valve, on the other hand, is noncircular saddle shape and sits in the middle of the heart. As a result, it’s influenced by the many different forces that act on the heart.
  • Location: In addition, the mitral valve is located close to the left ventricle outflow tract, an area in which blood flows out of the heart and into the major arteries. Those factors make mitral valve replacement much more challenging.

Unanswered Questions

While there continues to be a lot of enthusiasm for transcatheter mitral valve therapies, we have a long road ahead before these techniques become mainstream. There are many repair or replacement devices that are being studied. We also don’t know yet whether minimally invasive techniques might be more effective for repairing or for replacing the mitral valve. So far, it seems that mitral valve repair techniques are safer but less effective than mitral valve replacements using these catheter-based approaches.

It took a while before TAVR reached prime time – and it only got there after years of development and proof that the technique was as good or better than surgery. New mitral valve therapies must also pass that test before they become established as an alternative to surgery in patients healthy enough for operations.