8-31-09
Dear Doctor
I've been so busy trying to schedule and complete all the inclusion studies for the TAVI (Transcatheter Aortic Valve Implantation) Trial that I have had little time to check in with you. Now that my inclusion workup has been almost completed but for the final cardiac catheterization and aortogram studies, I have made a firm decision to withdraw from the TAVI Trial, and proceed with the standard Surgical Aortic Valve Replacement (SAVR). The surgery will be scheduled electively in October which will soon be upon us.
I am very relieved to have finally made my choice, but would Iike the benefit of reviewing with you my rationale and reasoning for finally choosing the standard surgical aortic valve replacement (SAVR).
Trying to identify my best prospects for AVR at my age and in my condition and circumstances has been an education as well as an emotional and stressful experience. So, how did it come about, and why the urgency now? I've had no pain, shortness of breath or other cardiac symptoms. But, as you recall, my aortic valve area by echocardiogram has been diminishing at the rate of about one millimeter every six months, as follows:
- May 2006 - Ejection Fraction of 57%
& Aortic Valve Area of 1.1 cm2
- Aug. 2008 - Ejection Fraction of 66%
& Aortic Valve Area of 0.9 cm2
- Feb. 2009 - Ejection Fraction of 65%
& Aortic Valve Area of 0.8 cm2
Following the February 2009 echocardiogram my new cardiologist opined that I needed have my aortic valve replaced. "And sooner rather than later", he added. I had been living well for my age with a "robust" aortic murmur for a good number of years. But like many asymptomatic patients, I had been in denial about the progressive nature of aortic stenosis. And so, my cardiologist’s ultimatum for major cardiac surgery came as a bit of a shock, and a challenge to my equanimity as an octogenarian. Where to begin?
"Well, if I need cardiac surgery, who does the most and the best aortic valve replacements these days?" I asked him. And he, who had his own medical training at Yale and Penn immediately replied without batting an eye, "The Cleveland Clinic". However, sensing my reluctance to immediately pack a bag, he suggested that I get started by obtaining an initial surgical opinion from a local surgeon, as well as look into the Percutaneous Edwards Partner Trial. I did both. The physicians involved were each listed among the very top cardiac surgeons in the area, so I proceeded with confidence in both of them.
On studying my records and examining me, the one highly regarded cardiac surgeon opined that I was indeed a reasonable candidate for surgical AVR. Another highly qualified cardiac surgeon, however, strongly recommended that I try to qualify for the Percutaneous Transfemoral Valve Trial. And so, persuaded by that, I have been proceeding, as you know, with the Trial’s Inclusion Studies which are now completed but for the final cardiac catheterization and aortogram.
During all that time, I’ve been in a quandary, trying to study the literature and process as much as I can about my best options and prospects as an 87-year old in need of Aortic Valve Replacement. Major cardiac surgery is a complex team effort, but it is not rocket science.
It is medical science, and I certainly ought to be able to read about it and study what needed further understanding. In doing so, a number of recent items have made me a bit circumspect, if not leery, about the risk/benefits and trade-offs of Transcatheter Aortic Valve Implant procedures (TAVI) vs. surgical Aortic Valve replacement (SAVR).
One such item is the recent Online Cardiac Conference for CME credit, featuring Drs. Jeffrey Popma, Neil Moat and Eberhard Grube which is well worth a look - at following Link, if you haven't seen it:
http://dme.cybersessions.com/conference/978489/
From their discussion of the European experiences (where the transcatheter valve implant has been approved since 2007) it seemed to me that adverse results with Transcatheter implant (TAVI) would be fewer than with surgical AVR only in the first year, and would likely be greater with TAVI than with surgical AVR in the second and subsequent years.
A further item that gave me pause is their chart of Adverse Outcomes at Thirty Days on 1,483 patients (with an average age of 85) who underwent Transfemoral Aortic Valve Implants:
- Mortality 10.3% at 30 days
- Stroke 2.2% at 30 days
- Major arrhythmias 15.7% at 30 days
- Pacemaker 25.0% at 30 days
- Major Bleeding 6.9% at 30 days
As I read this, it appears that some of the adverse outcomes with TAVI at 30 days might equal, if not exceed, some of the risks for Surgical AVR as reported by experienced centers such as the Cleveland Clinic – and could equal or exceed the risks that I might personally experience at my age with a Surgical AVR. Is that not correct?
Now, by way of serendipity and amazing coincidence, Mark Mendel, a close friend of my son Paul since their teenage days, happened to be visiting him a few weeks ago from Arizona, and I joined them for the weekend at our Maryland shore. I had forgotten that Paul's friend, Mark, whom I hadn't seen in a number of years, had obtained a Ph.D. at U.Penn. in Bioengineering. And when the talk turned to my aortic valve replacement needs, Mark who is not a physician, turned out to have had much more contact than I would have imagined with the science of bioprosthetic aortic valves. This, to my surprise, was based on Mark's experience in working closely with a fellow bioengineer named Ivan Vesely, Ph.D. who for some ten years had run the Cardiac Valve Research Lab at the Cleveland Clinic.
More recently, Dr. Vesely has pursued his cardiac valve interests as the Founder and Chief Scientific Officer of a company called ValveXchange that is developing a readily replaceable tissue valve especially for younger patients. During the time that Dr. Vesely ran the valve research lab at the Cleveland Clinic, Mark says it was the top funded heart valve research lab in the world. In 2006 Mark was a consultant to Ivan at ValveXchange, and in 2007 Mark Mendel served as CEO of ValveXchange.
At that time, Drs. Vesely and Mark Mendel assembled a very strong Clinical Advisory Board that includes top cardiac surgeons out of the Cleveland Clinic, such as Fred Loop, MD (former CEO of the Cleveland Clinic) and a highly regarded Dr. Michael Banbury who left Cleveland Clinic a couple of years ago to be Chief of Cardiac Surgery at Christiana Hospital in nearby DE.
Remember when I had first asked, "Who does the most aortic valve transplants with the best results?" my physician replied without a moment's hesitation, "Cleveland Clinic". Paul's friend, Mark, recommended that I see Dr. Michael Banbury who is now Chief of Cardiac Surgery at Christiana Hospital in nearby DE, after a number of years at the Cleveland Clinic. So, a week ago I sent Dr. Banbury my records and went to see him in DE with my son Paul. After studying my records, Dr. Banbury concluded that I was indeed an adequate candidate for the standard AVR surgery with cardiopulmonary bypass.
My son Paul and I were favorably impressed with Dr. Banbury who seemed to be at the top of his game in his late forties. In response to my direct questions, Dr. Banbury stated that he and his surgical team perform over 700 open-heart procedures annually, and that their results and statistics with patients my age equal those of the Cleveland Clinic "and in some ways are even better". The Cleveland Clinic's 30-day mortality figures with surgical AVR were about 1-2% overall and perhaps 2-4% with octogenarians in my general shape. In view of the transcatheter valve procedure's 30-day mortality figures of 10% and other considerations, I decided to forego the transcatheter valve trial.
More important, since open heart surgical AVR is widely regarded as the "gold standard" for suitable candidates, even for octogenarians, and because two cardiac surgeons found me to be a reasonable candidate for the standard surgery, that now seems to be clearly the way for me to go. So, what have I learned? Ultimately, and statistics aside, our individual surgical prospects need to be assessed based on our own medical situations.
I had initially given some thought to going to the Cleveland Clinic, but now it seems that the Cleveland Clinic has come to me at Christiana Hospital which is about 45-50 minutes from where I now live.
So, as my primary care doctor who knows well my status and overall medical situation, how does my thinking and rationale in coming to this decision, sound to you?
With warmest regards,
Dr. Mel Heller |
