NEW STUDY ON ANGIOGRAMS AND HEART SURGERY SHOWS NO RISK; ONLY UPSIDE SPECIFIC TO PATIENT TIME, MONEY AND STRESS ACCORDING TO MAYO CLINIC

Patients who are to undergo heart surgery generally have their angiography tests several days or weeks before their operation, the reason being that such angiography might lead to kidney failure. Now a new study by doctors at the Mayo Clinic has found that heart surgery patients can have angiography tests on the same day as elective valve surgery without facing any additional risks.

A team of doctors at the Mayo Clinic led by Dr. Hartzell Schaff performed elective valve repair or replacement surgery on 226 patients between August 2000 and August 2004. All the patients had received an angiography on the morning of their surgery.

The doctors observed that none of the patients going into surgery faced any complications on account of the tests. Only four patients were found to have developed renal failure, at rate of 2.2%. This was well within the normal renal failure range of 1.1 to 3.7%.

Of these four patients, one died due to multi-organ failure, giving a mortality rate of 0.4%, which again was in the normal range. This led doctors to the conclusion that angiography tests for patients of elective valve surgery on the same day as the procedure does not in any way increase risks of complications.

The doctors believe this is on account of the significant improvements in methods that have been achieved over the years. “It has become exceedingly safe and a very simple procedure because they use smaller catheters and smaller amounts of dye,” explained Dr. Schaff, co-author of the study and a cardiac surgeon at the Mayo Clinic.

“In properly selected patients, same-day coronary angiography is safe and has little impact on renal function,” the authors concluded in a paper published in this month’s issue of Mayo Proceedings. Dr. Schaff however stressed that angiography tests should be carried out same day of surgery only for patients who are stable and have a low risk of renal failure.

There are roughly 48,000 heart valve replacement or repair surgeries in the US every year and majority of these are elective. The new procedure found by the doctors can save these patients not just money but also relieve them of the stress of having to visit the hospital multiple times.

As many of you know, during the past three months I have coordinated an extensive online survey of almost 100 former, heart valve surgery patients and caregivers. The objective of this study was to better understand the impact and realities of heart valve surgery in their lives.

I have to admit, this was a very interesting and eye-opening experience. In addition to the online survey, I also spoke with and interviewed many doctors, nurses, patients and caregivers in the hopes of helping future heart valve repair and replacement patients.

One of the most curious survey results contained within this study was specific to “second opinions”.

As I have written before in this blog, it is my opinion that obtaining a second opinion is a critical step leading up to a patient’s heart valve surgery. (Especially with the recent medical frauds detailed and exposed in books like “Coronary” – See “Having Heart Valve Surgery? First Get A Second Opinion!”)

That said, one of the questions asked in this survey was, “Did you get a second opinion to confirm your valve disease or defect prior to surgery?”

I was definitely surprised when I saw the results shown on the figure below.

As you can see above, 35% of patients did not acquire a second opinion prior to having heart valve surgery. For me, this is a problematic, mis-step in the process leading up to cardiac surgery – regardless of whether it is either an open heart procedure or a minimally invasive valve procedure.

Again, it is my opinion that all future patients take the time to acquire a second everything – a second EKG, a second diagnosis, a second this and a second that.

As for the other survey results contained in this study, over 35 multiple choice and essay questions were asked in this survey and provided in The Patients’ Guide To Heart Valve Surgery (Revised Edition).

Here are some examples of the other questions asked to former patients and caregivers:

1. What is your “Best Piece Of Advice” for future heart valve surgery patients and caregivers?

Hey everybody!

I just saw this release. Looks very, very interesting for the heart valve surgery community! Cheers…. Adam

British researchers announced amazing results using stem cells to grow heart tissue, including a heart valve. Imperial College of London heart surgeon and Professor Sir Magdi Yacoub believes this breakthrough could lead to growing whole replacement hearts from stem cells.

Ultimately the goal is to grow a whole, beating human heart. Professor Yacoub told the UK Guardian newspaper that “It is an ambitious project but not impossible. If you want me to guess I’d say 10 years. But experience has shown that the progress that is happening nowadays makes it possible to achieve milestones in a shorter time. I wouldn’t be surprised if it was some day sooner than we think.”

Yacoub and his team used chemicals as “physical nudges” to coax stem cells extracted from bone marrow to grow into heart valve cells. The process involves placing the cells into “scaffolds” made of collagen. But there are hurdles involved. “That work has then extended into looking at the incidence of nerves in the valve – these can cause the types of contractions and relaxations in a very specific way,” explains Adrian Chester, one of the lead scientists.

Chester and his colleague Patricia Taylor grew small 3cm-wide discs of heart valve tissue. They hope to place the tissue into animals later this year. Sheep or pigs will likely be used. They will monitor to see how well it works as part of the circulatory system.

The Guardian report suggests that this technology could be used in “patients within three to five years.” There are advantages to using real heart valves and tissue as opposed to artificial valves. “The way a living valve functions, it anticipates haemodynamic events and responds and changes its shape and size. It’s completely different from an artificial valve which will just open and shut. The heart muscle itself will appreciate something which will make it free to contract properly,” said Prof Yacoub.

Although the British researchers say this is a first, back in June of 2006 Australian scientists were able to grow heart tissue using stem cells. Professor Wayne Morrison, from Melbourne’s Bernard O’Brien Institute of Microsurgery predicted back then that their discovery will ultimately lead to the creation of human organs.

TO LEARN MORE ABOUT HEART VALVE SURGERY, VISIT THE VALVE SURGERY LEARNING CENTER, BY CLICKING HERE.

Edwards Lifesciences Corporation, the world leader in the science of heart valves, announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of its Edwards SAPIEN transcatheter aortic heart valve technology. The PARTNER (Placement of AoRTic traNscathetER valves) trial will evaluate the SAPIEN valve in patients who are considered high risk for conventional open-heart valve surgery.

“This is a significant and exciting milestone for our transcatheter heart valve program and for Edwards Lifesciences,” said Michael A. Mussallem, chairman and CEO. “We have worked closely with the FDA to design a trial that will compare the innovative SAPIEN heart valve with the current standards of care for high risk patients. We believe our revolutionary technology holds promise for the large number of high risk patients suffering from severe aortic stenosis.”

Edwards’ PARTNER trial is a prospective randomized clinical trial with two separate treatment arms. The surgical arm of the trial will focus on approximately 350 high risk patients who are candidates for conventional open-heart surgery. Those patients will be evenly randomized to receive either the Edwards SAPIEN transcatheter heart valve or surgical valve replacement. The clinical results of this arm will need to demonstrate that the SAPIEN valve is not statistically inferior to conventional surgery.

The medical management arm of the trial will focus on approximately 250 patients that are considered too high risk for conventional open-heart surgery. Those patients will be evenly randomized to receive either the Edwards SAPIEN transcatheter heart valve or appropriate medical therapy. The clinical results of this arm will need to demonstrate that the SAPIEN valve is statistically superior to medical management.

The primary endpoint in both arms of the trial is mortality at one year with secondary endpoints that focus on valve performance and quality-of-life indicators. Each arm of the trial contains a sufficient number of patients to support independent statistical analysis.

Initially, clinicians in the PARTNER trial will deliver the SAPIEN valve using Edwards’ RetroFlex transfemoral delivery system. In the third quarter of this year, the company expects to add its Ascendra transapical delivery system to the trial. “We are pleased with our global transapical experience and look forward to making Ascendra available as soon as possible,” said Mussallem.

Edwards will start enrolling at two initial study sites: New York-Presbyterian/Columbia University Medical Center, New York, and The Cleveland Clinic Foundation, Cleveland, Ohio. Both sites were part of the company’s earlier transfemoral feasibility study. Before expanding to 15 U.S. study sites, Edwards needs to submit additional follow-up data from the original 55-patient feasibility study.

About Transcatheter Heart Valve Replacement

The Edwards SAPIEN transcatheter aortic heart valve integrates balloon-expandable stent technology with a replacement tissue heart valve. The SAPIEN valve is compressed onto the balloon to the approximate diameter of a pencil and threaded through the patient’s circulatory system from the leg or inserted between the ribs and expanded directly over the aortic valve. The SAPIEN valve is a proprietary technology designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood flow) who are considered to be high risk for conventional open-heart valve replacement surgery. The therapy was originally developed in conjunction with Prof. Alain Cribier, M.D., chief of cardiology at the University Hospital in Rouen, France, who performed the first transcatheter valve replacement in April 2002.

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company’s global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT Magna, and Swan-Ganz. Additional company information can be found at http://www.edwards.com.

Edwards Lifesciences in Irvine, California has been making artificial heart valves since 1960, so it thought it knew the ins and outs of treating valve disease.

But since 2004 it has run into many surprises — some encouraging, some upsetting — as it worked on a system for implanting valves without open-heart surgery.

One of the biggest discoveries was how much Edwards Lifesciences had to overhaul the technology, which it purchased as part of a $125 million-plus corporate acquisition.

Another revelation was how many people might want the product if the Edwards catheter system for heart valves lives up to its potential.

“There’s a large untreated patient population,” says Larry Wood, corporate vice president in charge of catheter-implanted heart valves at Edwards. “That was a bit of news to us as a No. 1 heart-valve maker.”

Edwards knew that while about 100,000 patients have open-heart surgery in the United States each year to replace failing valves, another 100,000 need new valves but don’t get them. The main reason: Their health is too poor for major surgery, which makes them candidates for a catheter-based system.

Then in 2005 and 2006, medical researchers found that even more patients suffer from valve disease. Two studies revealed valve malfunctions in a third or more of elderly patients who undergo stress tests, even though they had no symptoms otherwise.

Although Edwards hasn’t released an estimate of how much it could gain from commercial success of what it calls the Edwards-Sapien valve system, it’s vying for what’s potentially a multi-billion-dollar market.

EARLY PROBLEMS

Unpleasant surprises occurred soon after Edwards acquired the catheter system in its 2004 purchase of Percutaneous Valve Technologies Inc. of Fort Lee, N.J.

The system had been developed by a PVT subsidiary in Caesarea, Israel, and by interventional cardiologist Alain Cribier of Rouen, France, who used it to implant the first aortic valve through a catheter in 2002. He inserted the catheter through a vein in the leg, threaded it upward to the heart, following the direction of blood flow, then twisted it through the chambers of the heart to the aortic valve.

Cribier, with more than 10 years of experience using balloon catheters to treat calcified heart valves, had repeated successes with that procedure. But when initial trials conducted by other doctors began in the United States, a number of the first patients died. Edwards decided it needed to intervene.

In mid-2005, it halted the trials and began making changes.

Edwards concluded that Cribier, as a pioneer of balloon-catheter surgery, was able to succeed in procedures too difficult to teach to other doctors, Wood says.

So, it changed Cribier’s tortuous route through the heart to the aortic valve, which sometimes caused damage to other heart valves along the way. The new route was against the direction of blood, but more direct – from a leg artery up to the aorta and through it to the aortic valve.

Since restarting the feasibility trials in early 2006, results have been more encouraging. At hospitals in New York, Cleveland and Dallas, 55 gravely ill patients with an average age of 82 received catheter-delivered implants of Edwards heart valves. After 30 days, only about 7 percent had died, compared to a projected 33 percent if they had open-heart surgery.

Such results are part of the reason why Vasilis Babaliaros and Peter Block of the Emory University School of Medicine call the Edwards and CoreValve devices a “drastically improved” technology.

CONTINUAL CHANGE

With a staff of 100 working on the technology in Irvine and Israel, Edwards keeps improving the technology.

New tissue. The valves had been made from the pericardial membrane surrounding a horse’s heart. Now, like other Edwards valves, they’re made of pericardial tissue from cows.

That means they can run through the same quality tests that Edwards uses for other tissues, including a computerized measure of thickness, mechanized dye-cutters to assure standard sizes, anti-calcification treatment, and a test to make sure that the three leaflets in each valve have matching elasticity.

New catheter features. In the Edwards Retroflex system, the catheter contains a lever that allows the cardiologist to curve the catheter tube to follow the curve of the aorta.

Two routes instead of one. Edwards has devised a second new route for a catheter to follow – through a small incision between the ribs and through the apex, or tip, of the heart. This system, called the Ascendra delivery system, is for patients with arteries too narrow or diseased for the Retroflex catheter.

“We’ve been making heart valves (of bovine tissue) since 1982, so we apply all our experience,” Wood says.

Based on those improvements and the results it has achieved with a total of 300 catheter-delivered valve implants worldwide, Edwards anticipates receiving approval to sell its system in Europe by the end of this year.

It hopes for approval from the FDA by this month for a randomized clinical trial. If all goes well, approval to market the Edwards-Sapien valve system in the United States could come by 2010.