Category Archives: Valvular Heart Disease

ACC15 Presentations Make Nonsurgical Aortic Valve Replacement Look Very Promising

At the ACC meetings yesterday, several “late-breaking clinical trial” presentations provided substantial reasons to be enthusiastic about transcutaneous aortic valve replacement (TAVR) in comparison to standard surgical AV replacement (SAVR).

Five Year Results of First Generation TAVR Show Durability

Michael Mack, from Baylor, presented the 5 year follow-up of the ground breaking PARTNER trial results  and they were simultaneously published here.

This study randomized high risk surgical patients with severe aortic stenosis to treatment with a balloon-expandable bovine pericardial tissue valve employed by either a transfemoral (2/3) or transapical approach or a standard surgical aortic valve replacement.

There was no difference in death rate at 5 years between TAVR (68%) and SAVR (62%) in this trial of Edwards Lifescience’s first generation Sapien device.

Interestingly, follow up with echocardiography showed durability of  both surgical and catheter-implanted aortic valves with the mean gradient staying at 11 mm Hg and aortic valve areas at around 1.5 cm2.

Two Year Mortality/Stroke Rates Show Superiority of Corevalve TAVR over SAVR

The very next presentation at this session came from another surgeon from Texas named Mike, the cocky and folksy Mike Reardon, on the two year results of a competing technology in the TAVR field.

The Corevalve TAVR device made by Medtronic is self-expandable as opposed to the balloon-expanded Sapien device and Dr. Reardon declared the results with this device so good that they were “unique and provocative”.  Slides of presentation available here.

Indeed, the Corevalve TAVR two year follow up results showed a significantly lower mortality rate for TAVR (22%) versus SAVR (29%) and a LOWER stroke rate for TAVR (11%) versus (17%).

There was no difference in major stroke between the approaches.
TAVR had a lower mortality plus major stroke rate (24%) versus SAVR (32.5%).
These were dramatic results, indicating for the first time that TAVR may be a superior approach for aortic stenosis in patients who are high AND intermediate in their risk for surgery.
In the discussion that followed, Dr. Reardon asserted that TAVR using the Corevalve approach should be considered the preferred approach to high and intermediate surgical risk patients with severe aortic stenosis.

Will TAVR Become The Procedure of Choice for Severe Aortic Stenosis?

These studies suggest to me for the first time that TAVR may ultimately replace SAVR for all patients with severe aortic stenosis, low to high in their risk for surgery.

Clearly, we need ongoing follow up of these patients and more long term data, but as these devices improve and the operators gain more experience it is likely that results will only get better.

This represents a huge paradigm shift in our approach to valvular heart disease.

Skeptically Yours,

ACP

Cardiology Marketing: A Plea For Honesty and Scientific Accuracy

In the last few years the skeptical cardiologist finds himself inundated and sickened by slick promotional material from various hospitals across the country. These pamphlets typically tout the cutting edge research being done or the latest surgical and catheter-based techniques that the cardiologists at their facilities are doing.

Obviously, a lot of marketing energy and money is being expended by hospitals in an effort to lure patients away from their normal referral hospitals to come to these hospitals located in cities like Cleveland, Baltimore, Los Angeles and New York.

It is my sense that the doctors who are featured in these print infomercials either don’t proofread the advertising copy or they are shamelessly engaging in overhyping procedures that are, at best, marginally better than those available in the community.

Robots For Heart Surgery

Let’s take the latest example I pulled from my office mail which is the “Cardiovascular Report” from Johns Hopkins Heart and Vascular Institute.

Each article in the four page glossy pamphlet, comes replete with a large color picture of a photogenic doctor who looks incredibly earnest and dedicated.

Each article begins with an anecdote which has become a staple, it seems, for all medical reporting. We learn of a specific patient who had a particular cardiology problem. After bungling by the local doctors, the patient is very fortunate to have been referred to Johns Hopkins where cutting edge knowledge, elite cardiologists, and often a new surgical or catheter-based procedure dramatically effected their outcome.

Although the story of one patient makes for dramatic reading and human interest, patients should never make decisions on what procedures to do based on such anecdotes.

The story entitled “An Ideal Candidate for Robotic-Assisted Mitral Valve Repair” begins with an anecdote about Jim Watkins of Overland Park, Kansas who knew he had a heart murmur and was diagnosed with “benign mitral valve prolapse” and told by his cardiologist “not to worry about it but to have a follow-up every three years or so.”

The article implies that such a conservative approach was foolish, but the vast majority of mitral prolapse patients with less than severe leakage from their mitral valves are best managed this way. One of the major criticisms of cardiologists is that we perform too many tests too frequently.

A routine echocardiogram (heart ultrasound) revealed “moderate-to-severe mitral valve leakage and marked leaflet regurgitation.”  This phrase could not have been proofread by a competent doctor because mitral leakage and regurgitation are describing the same thing. The story quotes the patient as saying that “they wanted me to have open-heart surgery before Christmas.”

Assuming that Mr. Watkins was free of symptoms at this point, and that the function of his left ventricle was normal, there would be no reason to rush into surgery for moderately-severe mitral regurgitation.

The patient began exploring options and “learned that minimally invasive robotic repair was an option that offered faster recovery and minimal scarring.”

I’m pretty certain he learned all the positives of the technique from a website like that of Johns Hopkins, Cleveland Clinic or Mayo Clinic, who specialize culling the best mitral repair candidates from the population across the United States.

The articles then states “The Midwest hospitals that could do it, however, had months-long waits.” I find this statement totally unbelievable. I know that the longest wait I have ever noted for such surgery in St. Louis is about a week.

The article goes on to say that “the patient found, by expanding his geographic search, Dr. Kaushik Mandal at Hopkins. Within 5 minutes Mandal returned the call” (in all of these medical anecdotes, the doctors are incredibly responsive and compassionate in addition to promulgating the latest, most expensive techniques in cardiology).

He flew to Baltimore and had the mitral valve surgery and was discharged a week later with “no restrictions.” The reader could not have been in any doubt about the outcome for Mr. Watkins, as this one case was selected from the entire experience of the hospital to highlight a good outcome.

One has to question, however, that the patient was discharged with “no restrictions.” Really? The doctors were fine with activities such as driving a car and lifting heavy boxes one week after a thoracotomy?

A more significant criticism of this promotional puff piece and similar marketing material is the total lack of an objective, balanced approach to the risks and benefits of the procedure compared to standard approaches.

Is there any evidence that robotic assisted mitral valve repair provides superior outcomes to non-robotic assisted minimally invasive repair? No.

Dr. Alfredo Trento, a proponent of the robotic mitral repair system approach writes

A consensus statement of the International Society of Minimally Invasive Cardiac Surgery (ISMICS) 2010 on minimally invasive vs open mitral valve surgery concluded, on the basis of review of retrospective studies, that, in patients with mitral valve disease, minimally invasive surgery either robotically or through a right minithoracotomy may be an alternative to conventional mitral valve surgery, given the similar short and long-term mortality and also the reduced sternum complications, transfusion requirements, and hospital stay. However, the risk of stroke was higher with minimally invasive surgery than with conventional approaches (2.1% vs 1.2%) as was the risk of aortic dissection, phrenic nerve palsy, and groin complications; additionally, cross clamp times and cardiopulmonary bypass time were increased.

Far too often in medicine, hospitals adopt the latest and greatest expensive technology or procedure before it has been proven superior to existing approaches.

One of the major driving forces behind this reckless spending is marketing the hospital and it’s “cutting-edge” approach to disease management.

As patients and physicians, we need to resist this kind of marketing and insist on an honest and balanced approach to evaluating newer technologies and surgical approaches.

Cardiologists and cardiac surgeons working in the centers that produce this kind of misleading marketing material should take responsibility for what is written and insist on an accurate description of the advantages and disadvantages of their techniques.