EVALUATION OF LAF SURVEY 9

Introduction

The evaluation of LAF survey-9 turned out to be a very major undertaking indeed. With 193 afibbers responding to almost 100 questions about their ablation, maze or other procedures close to 20,000 data points had to be extracted, arranged and evaluated. This issue of The AFIB Report evaluates the results of radiofrequency ablation. Results of maze, mini-maze and other procedures will be presented in the next issue.

The volume of data is clearly good as far as being able to draw valid conclusions, but less desirable as far as being able to present the data and conclusions in a readable and comprehensible format. I am fairly certain that the LAF survey-9 is the largest ablation survey ever done in the "real world". In other words, a survey in which the information is provided by the patients who underwent the procedures rather than by the EPs or institutions that performed them.

This report has been divided into five major sections: –

• Update to Afib Database
• Evaluation of LAF Survey 9: General Data
• Evaluation of RF Ablation Results
• Final Outcome of Procedures
• Performance Rating

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The initial step
I am a 55-year-old male in good physical condition except for my Afib. Over the past 25 years I have competed in 35 marathons, dozens of triathlons and many ocean swimming races, including a swim from Alcatraz. In 1997, I finished the Hawaiian Ironman triathlon. In addition, I have observed a heart-healthy, very low fat diet for 25 years. My Afib symptoms began over five years ago. My principal trigger was strenuous, anaerobic exercise (as opposed to, say, easy jogging or swimming). However an Afib episode also would pop up occasionally for no apparent reason. In March of 2004 I was alerted by Hans Larsen's Afib Newsletter that a paper had been published by investigators at the Cleveland Clinic reporting a pulmonary vein ablation (PVA) success rate of approximately 80% with an incidence of stenosis (a principal concern for me and the reason I elected not to have the procedure sooner) in the 2 – 5% range. I phoned the Cleveland Clinic immediately, hoping to obtain an appointment with Dr. Patrick Tchou. I chose Dr. Tchou largely because, in checking on his publications in MedLine, I found him to be widely-published in the field of electrophysiology and PVA. The earliest appointment with Dr. Tchou that I could obtain was not until November 2004, almost seven months away at that point.

In September 2004, the Cleveland Clinic phoned to inform me that they would have to reschedule – pushing my appointment back to January 2005. By this time, I already had booked my airline reservation from Laguna Beach, California to Cleveland. A bit of whining on my part elicited a compromise date of December 2, 2004. At that appointment, I was examined briefly by a nurse. Then, I met with Dr. Tchou, who patiently and thoroughly counseled me as to my options, apart from PVA. Dr. Tchou is a warm and sincere person who, despite his extremely busy schedule, took ample time to ascertain my goals and expectations and to thoroughly educate me as to all of the treatment options that were available to me. Clearly, it was not his goal simply to "sell" me an ablation procedure. However, I was determined to go forward and, since I was found by Dr. Tchou to be an appropriate candidate for PVA, I was scheduled to have the procedure upon the soonest available date – April 19, 2005! This was to be 13 months after the date upon which I originally had contacted the Cleveland Clinic. In fairness, I could have been seen by other physicians at the clinic much sooner but I am a firm believer in entrusting substantial body parts such as my heart only to those physicians in whom I have the greatest confidence. In this case, going first class cost me no more as Dr. Tchou and the Cleveland Clinic are participants in my relatively no-frills Blue Cross PPO plan. Therefore, I was able to self-refer with no out-of-plan surcharge by my insurance carrier.

The procedure
On April 17, 2005, I checked into the Cleveland Clinic Guesthouse, a hotel located immediately adjacent to the hospital. Patients can also elect to stay at the affiliated and considerably more upscale Intercontinental Hotel, which is connected to the hospital by an enclosed walkway. On April 18th, from 10 A.M. until 1 P.M., I underwent a series of tests, including a CAT scan, electrocardiogram, EKG, and various blood tests. I had been instructed to discontinue Coumadin three days prior to my procedure. Dr. Tchou had started me on Coumadin two months in advance of my scheduled procedure date. Previously, I had been taking only a daily aspirin, prophylatically. I spent the night before the procedure in my hotel room with orders to eat or drink nothing after midnight.

The next morning, at 6 A.M., I reported as directed to the check-in desk at the Cleveland Clinic's Electrophysiology Lab. I was relieved of my "civilian" clothing, issued a gaily-patterned and generously-vented hospital gown, shaved, and I'V.'d – one I.V. in each forearm. A saline drip was started. I was then invited to use the restroom (I declined and, of course, immediately began imagining that I had to "go" but it was too late for regrets). I was allowed to walk to the procedure room under my own power, wheeling my metal I.V. stand along beside me and, caught up in the solemnity and magnitude of the moment, feeling a lot like Charlton Heston wielding his wooden staff in the Ten Commandments.

The procedure room resembled a small O.R., which it was, except that there were a lot more monitors and electronic gizmo's than usual festooning the walls and ceiling. The O.R. nurses were affable and attentive and we joked amiably as they arranged me on the table and introduced the magic, twilight sleeping potion into one of the I.V. ports. I was told, and also had read, that I would be awake, though sedated, throughout the procedure. I was also told that I might feel pressure or an occasional twinge of "discomfort". In fact, felt nothing, saw nothing, and remember nothing. My last recollection is of myself nervously regaling the O.R. staff with an "amusing" anecdote (for which the staff graciously accorded me a courtesy laugh). The next thing I knew I was being awakened by a smiling nurse who informed me, "Okay, it's all over – everything went just fine." The procedure had taken about four hours.

The recovery
I was wheeled to a recovery area which contained about ten beds arrayed around a central nurse's station. Privacy was afforded by standard hospital curtains surrounding each bed. There was just enough room in each patient cubicle for a heart and blood pressure monitor, a visitor chair or two, and a TV. Within thirty minutes of returning from the procedure room, I was offered a hot and hearty lunch and, later, I ate an excellent dinner, which I was able to order from a multi-choice menu. I was subjected to minimal handling, while receiving wonderful, seeing-to-my-every-need care from the congenial and capable nurses. No blood was drawn from me and only two EKG's were taken at bedside. I was attached to a heart monitor and, overnight, to a Holter monitor. I was required to keep my legs straight - no bending – for six hours after returning from the O.R. Sterile wadding had been placed in my groin and bound tightly to prevent bleeding and excessive bruising (I had been heparinized during the procedure to prevent clotting and potential embolism).

After six hours, my thighs were unbound and I was allowed to stand and even walk to the bathroom. Unlike another patient, who reported in the Afib Newsletter that he did not urinate for some time following his procedure, I was up every couple of hours with an urgent need rid myself of copious amounts of fluid. Perhaps this was a function of the volume of our respective I.V. drips or perhaps my need to urinate was caused by the diuretic effect of the prednisone tablets I began taking (and continued for a week thereafter) immediately upon returning from the O.R. That first night passed without much discomfort – a little soreness in my groin and a bit of a dull ache in my chest but nothing worth complaining about.

The next morning at 9 A.M. sharp, less than 24 hours following my procedure, I was released. I eagerly dressed, received my instructions (no heavy lifting for three days – okay to resume normal activities in seven days), was issued a week's supply of prednisone tablets, and bolted from the hospital. I was able to walk unaided the hundred yards or so back to the hotel, albeit still a bit sore in the groin and swaggering with a cowboy's bowlegged gait as a consequence. I had planned originally to spend that night in the hotel and fly back to California the next day but, since I was feeling so good, I hurriedly packed my bags, checked out of the Cleveland Clinic Guest House, and took myself off the to the airport where I traveled unaided from Cleveland to Orange County's John Wayne Airport by way of a stopover (complete with long walk between terminals) in Dallas-Ft. Worth.

The return to normal
In the days that followed, I felt a bit of transient soreness in my chest and had some very minor bruising in my groin but, seven days after the procedure, I went for (an easy) five mile run. For the most part (and on Hans' suggestion) I took it fairly easy for the first month. One week following my procedure the tiny incisions in my groin had healed nicely and so, with Dr. Tchou's blessing, I resumed surfing. I have since resumed full athletic activities at normal intensity. How about the Afib? Well, I was warned that I would continue to experience transient Afib episodes for up to eight weeks as the scar tissue that would eventually interfere with the errant electrical signals was forming at the site of the lesions that were created in my pulmonary veins. I was told that these Afib episodes might even be more frequent and more severe than before the procedure. They weren't kidding. Early on I experienced a minor Afib episode in association with almost every physical exertion that raised my heart rate. However, the episodes I experienced were all of very brief duration, resolving within minutes of cessation of activity, and these became increasingly less frequent as the weeks passed.

Upon my discharge from the Cleveland Clinic, I was loaned a nifty device consisting of a polyurethane case about ten inches long by eight inches wide and three inches thick. It contains two wristbands, each attached to a wire leading into the case. There is a molded cradle that accepts a standard telephone receiver. The device is powered by a small battery. When I experienced symptoms, I was supposed to phone into the Clinic, day or night, don the wristbands, and thereby transmit my pulse rate through the phone lines to a technician at the Clinic. I was to be monitored in this fashion for three months, at which time I was to return to the Cleveland Clinic for a follow-up examination.

As I write this, it is three months after my procedure. My Afib episodes decreased in number for about four or five weeks, at which point they ceased entirely. I now run every day, often hard, pushing my heart rate into the anaerobic zone – something I haven't been able to do in years. I am also surfing and swimming several times a week. Despite this level of activity, I have not experienced an Afib episode in weeks. The quality of my life has improved immeasurably and, most importantly, I feel like myself again for the first time in five years.