Pioneering spirit

Collins English Dictionary defines the pioneering spirit as a willingness to endure hardship in order to explore new places or try out new things. In speaking with Dr. Weiss, this spirit quickly becomes evident.

Dr. Weiss practices with his wife, Margaret Weiss, MD, FAAD, and partner Karen Beasley, MD, FAAD, at the Maryland Laser, Skin & Vein Institute in Hunt Valley. Despite his humble demeanor, he has been an instrumental force in advancing education in phlebology and in the development of new technologies that have improved patient outcomes and overall satisfaction.

Many of his achievements and, in fact, his career path, were accomplished without any type of road map, and were not always met with acceptance. This is what makes what he has to say all that more compelling. Be it his role in the development of radiofrequency ablation, or his thoughts on the ethical nature of treating veins, his words echo a spirit of pioneering and the ability to foster cooperation in the face of opposition.

VM: Your background in the treatment of venous disease and advancing phlebology is impressive, but what was your path to becoming a dermatologist and how did you become interested in veins?

I’m very visually oriented. Going through medical school, I learned the things that weren’t for me, like treating diabetes or taking blood pressures and listening to hearts and lungs all day. The main two fields I was considering during medical school were radiology and dermatology, which are both visually stimulating fields in medicine. Of course, you have to enjoy the rotation when you are going through medical school, and I really enjoyed both of those. The nice thing about dermatology is that you get to do certain surgical procedures as well, and surgery is a very visual element of medicine.

I first did a medical internship and went into radiology for one year. I thought it would be a lot of fun. At that time, CT scanning was just starting and I thought I would get to work with a lot of sophisticated devices. Unfortunately, one of my first rotations was doing barium enemas, and I started thinking that it wasn’t really what I wanted to be doing. In addition, I would stand and read chest x-rays for hours at a time. After a while, I didn’t want to measure the cardiothoracic ratio anymore; it just wasn’t stimulating enough for me, so halfway through my radiology residency I decided to change. Fortunately, a slot opened up in dermatology, so I applied for it and I got it.

At the time I was doing radiology, my wife was doing dermatology—and she was really enjoying it. I knew a fair amount of physics; it was always one of my best subjects. I kind of saw the future of dermatology, and knew we would be able to apply that skill set to this field. This was at the infancy and the development of lasers and CO2 lasers, and I had a hunch I would be involved in the research and development of new devices.

This was in 1982 or ’83, and there was really no practice of treating vein disease at all, other than a crude stripping procedure that had been developed in the 1940s. There were venous procedures being taught in France, but really nothing in American medical schools, and I had very little experience with vein treatment during residency. There were no textbooks in American literature, or even in English literature.

There was nothing to read about the procedure or learn from. There were no phlebology societies, either. We were completely in the dark. We would get patient requests from time to time about treating leg veins early on in practice, but there really wasn’t any readily available information—maybe one or two sessions in the AAD about treating spider veins, but it was very crude. It was like ‘OK, find a spider vein and inject hypertonic saline into it.’ The patient would cry out in pain, and the procedure was over.

After finishing the dermatology residency, I was planning on staying in academics. I was a fellow at the National Institutes of Health (NIH) in the dermatology branch, and my research was to grow capillaries from endothelial cells in order to develop a model for understanding vasculitis and disorders of circulation. So, it was kind of a natural progression to have this interest in veins. I understood about the process of how vessels could be diseased and new vessels could form in wound healing. I developed this interest in the vascular part of cutaneous medicine within the branch of dermatology.

About 18 months into my fellowship at the NIH, I realized I probably was not going to stay in academics, so I opened up my own practice. I was still very interested in vascular and veins, in particular, so my wife and I went to France. There was an International Society of Dermatologic Surgery meeting in Paris around 1986, and we decided that we would contact some of the people who were published in the treatment of telangiectasia and varicose veins, and that we would try to observe them. We were fortunate enough to observe Frederic Vin, who had a very well-known vein clinic in the American Hospital of Paris. We were also able to observe Andre Cornu-Thenard, who had a private clinic. That’s really where we learned sclerotherapy, and was the foundation of using that knowledge to understand what we were really doing and how to become interested in the venous anatomy.

Around that same time, the first organization for phlebology was being formed in the U.S. called the North American Society of Phlebology (NASP). I was the last president of the NASP. During my first term, I put a vote to change the name of the NASP to the American College of Phlebology (ACP) to reflect the surgical nature of the specialty, since ambulatory phlebectomy was becoming a technique that was gaining a lot of traction at that time. So, I have the distinction of being the last president of the NASP and the first president of the ACP, since the tenure for presidency was two terms (laughs). I think that the change of name to the American College of Phlebology was a big factor in giving the treatment of vein disease much more respect.

By that time, Mitch Goldman had published his textbook on sclerotherapy, and we decided that we needed to start publishing on sclerotherapy and Doppler examination, which led to duplex examination. So, we published papers on the lateral venous system and how they are connected to telangiectasia, and this all progressed over the period of about a decade.

At that point, people who were interested in veins had a great organization where international experts would come and teach on the treatment of veins. We relied on the French from the very beginning of the NASP to give lectures and teach us. They really helped to catapult the field in the U.S., and I don’t think we could have done it without their help. The ACP should always be grateful to our French colleagues for what they did in advancing the science and the medicine of phlebology in the U.S.

VM: The French have always seemed to be at the forefront of the specialty.

But as Americans, we added the tumescent anesthesia technique to improve ambulatory phlebectomy, and wanting to do noninvasive procedures led us to develop the first endovenous ablation system, which we started working on in 1996.

VM: That is a storied path, and historic in the outline of the field of phlebology in the United States. Who were your mentors?

Of course, Frederic Vin and Andre Cornu-Thenard. After that, it was Albert Adrian Ramelet, a dermatologist in Switzerland who taught me ambulatory phlebectomy. He learned the procedure from the father of ambulatory phlebectomy, Dr. Muller. Dr. Muller was the one who first had the idea of using his wife’s crochet hooks to remove veins—Ramelet was one of his students. Dave Duffy was another. Around 1985, he came to Johns Hopkins, where we were junior faculty, and he did live sclerotherapy demonstrations. At that time, he had the most experience of anybody doing sclerotherapy in the U.S. He strongly advocated polidocanol, even though it was not approved by the FDA at that time, because he was the first to realize the superiority of that solution.

Of course, Mitch Goldman is a mentor and has become a personal friend. I thought his first textbook was amazing, and now I am a co-author on his last edition. I am proud of that. John Bergen was certainly inspirational. He was dermatologist-friendly and thought that phlebology should include all specialties, and was always very upset if vascular surgeons would treat dermatologists as ’not worthy.’ He realized the importance of sharing information. Walter DeGroot taught me how to do Doppler exams and helped me understand reflux in the venous system. I remember having that ‘aha’ moment with him. He was an excellent teacher and very inspirational. He was an early president of the NASP and passed away too young.

I’ve learned an incredible amount from Jean-Jerome Guex. He had probably the largest fund of knowledge about polidocanol and its advantages. Martino Neumann taught me a lot about the lateral venous system, as did Hugo Partsch. My Doppler skills were honed with the help of Dr. Shultz-Ehrenburg in Germany, as well. These doctors were all very instrumental in my professional growth.

VM: That is an impressive list of mentors. You touched on an inclusionary approach to phlebology when you mentioned Dr. Bergen, and one of the prominent arguments around an inclusionary approach is ethics. As someone who is actively involved in the question of ethics, what do you feel are the real ethical challenges with respect to venous treatment?

I feel there are three main areas that we need to work on. First, we as physicians sometimes over-delegate and, sometimes, depending on state rules, it will be delegated to someone who does not have the required knowledge on venous anatomy and will look more at the monetary aspect instead of getting the best patient treatment and outcomes.

So, we have to look at who we delegate procedures to. What are their qualifications? Should there be some sort of ACP certification for these people? Should there be a written test to determine whether they have the basic knowledge to treat patients with venous conditions? This stems from the fact that many doctors in various specialties think that treating veins is really easy, that you can just stick a vein, and since they can take blood from a vein, that they can shoot into a vein. But obviously we know that there is a lot more than meets the eye. So, we need to make sure there are qualified people who are treating patients, or there will be poor results.

Second is an issue that has probably taken care of itself, which is compounded sclerosants. But I think that in large part because of the heightened scrutiny of the FDA and the fact that companies who promote compounded drugs by mail across state lines would then have to meet the same pharmaceutical grade standards, and we are seeing much less of that.

Third, I think we are seeing a problem with vein clinics that get patients in for a free examination and are misdiagnosing them with reflux so that an endovenous ablation can be done for profit. I’ve been seeing more frequently patients who are coming in for a second opinion who do not have reflux, and it concerns me. There is a conflict of interest when you do your own ultrasound and your own ultrasound report shows “reflux” and then you treat it. We have to come up with a way to minimize that situation. It’s akin to every patient who comes in with a little bit of chest pain and leaves with a stent.

We had an issue with a doctor in Maryland who was doing more stents than anyone else, and while it wasn’t necessarily harming the patient, he was putting patients through a procedure that they did not need. This is analogous to that. You aren’t going to cause any problems, but you haven’t fixed any problems, and patients with cosmetic leg veins of the lateral venous system with no saphenous reflux are not going to benefit. Ablation is a great technique, one that I am happy to have helped develop. I think it’s wonderful for people who would have otherwise had to undergo stripping, but I think it needs to be used appropriately.

VM: Do you feel there is a way to combat this?

I think the best way is public education, and I think the ACP can help work toward that. It’s difficult to police, and I think a mandatory session on ethics at the ACP would be helpful. But, it’s a tough thing. You can’t really teach someone ethics when they are struggling to keep their business and incomes from dropping. I would say the vast majority of physicians are ethical, but there are certain situations that can be taken advantage of because we are pretty much given free reign.

We are trusted to give patients an honest opinion and only provide those procedures that are absolutely necessary, but we have the freedom to decide whether a patient needs a procedure. Maybe in the case of reflux, more insurance scrutiny would help if they required an image with a report and had an independent observer look at the size of the vein. Other than that, I don’t really have a good answer.

VM: But raising the question poses the opportunity for discussion, which can lead to an answer. You mention being involved in the development of ablation. What got you involved in that and what other devices have you been involved in the development of?

The first vein device was in 1995-96, and that was an intense pulsed light (IPL) device. It was being promoted for leg telangiectasia. We actually figured out how to use it on facial telangiectasia, but it never really worked well for leg telangiectasia. But, it became a great device because at that time, the only other device we had for small vessels was an early version of the pulsed dye laser, which caused intense bruising with each treatment—we were looking for a nonbruising treatment. That led to my involvement with a lot of other devices for facial blood vessels.

But, the major device came from being involved with the ACP, which led to talks with the CEO of a small startup company named VNUS. This was around 1995. I used to fly out to an animal lab near the Berkeley campus and we would work on goats and sheep to develop the VNUS Closure procedure. I would fly out on Saturday morning and take the red-eye back so I could be with my kids on Sunday. I can’t remember how many times I did that. It’s easier when you are a lot younger (laughs). I can’t do that and function anymore.

We got the first working version in 1997; the major study was done in Germany. I would go to the FDA meetings with the company and talk about the importance of the development of a technique that saved patients from stripping. The first version of VNUS was approved in March of 1999. They thought the first version was going to be done under fluoroscopy, but Mitch Goldman and I made the suggestion that we do it under ultrasound. So, although we did all the initial experiments with fluoroscopy, the initial human trials were done with ultrasound, and that turned out to work very well. The clarity of the image has improved and ultrasound devices have gotten much less expensive, and now pretty much every phlebology practice uses ultrasound on a routine basis.

It was very exciting. The first version was difficult to use, though. It required having a drip in the center of the catheter and had electrodes that would get clogged with coagulum, and only a few people were successful at doing it.

Of course, the surgical community was up in arms. Any new development that threatens what is currently being done is going to be met with resistance. I was told by the vascular surgeons at Johns Hopkins in 2000 and ’01 that it would never work. There was a lot of negativity.

In the meantime, Robert Min had started working on using 810nm laser, after hearing about usi g the VNUS catheter at the ACP meeting, where it was first introduced in the U.S. It was met with great skepticism, of course. People were saying ‘What? Dermatologists are putting things in veins?’ We could get into veins as good as anyone else, and we know about local anesthesia.

Shortly after it was approved by the FDA, I thought, ‘Wait a minute—we have the ultrasound, let’s put in anesthesia under duplex.’ And then I realized we could compress the veins so the catheter makes good contact with the vein, and that really revolutionized the procedure. The company issued several patents based on my suggestion for the tumescent anesthesia to compress the vein, but I signed away all rights because I was told a method patent would have no value.

VM: (Laughing) They certainly proved otherwise, didn’t they?

Regardless, I think that was my major contribution to the field and it is gratifying to see everyone claiming it as their technology (laughs). It’s a great technique in all seriousness, and that is what wins out in the end. The 2007 version of ClosureFast has made it easy for everyone to use.

VM: They do say that imitation is the sincerest form of flattery. Are you currently working on anything now that you can discuss?

We have a really exciting development that could be the next phase in the treatment of venous disease. It’s under FDA review right now so I cannot go into great detail on it, but I can say it’s similar to using the glue that neuroradiologists use as a glue to close vascular malformations in the brain.

There has been a Phase III study that we have participated in, along with many other centers in the U.S., and it is already approved in Germany. The technique looks very promising for endovenous closure without risk of heat injury, and it has a number of significant advantages, the biggest of which is speed. In Germany, they don’t use compression afterward because if the vein is sealed immediately, there is no way it’s going to open back up again. I believe that this is where we are going. Of course, the FDA will review the efficacy and safety data at the completion of the trials.

VM: As we close, early in our interview you mentioned being past president of the NASP and ACP. What motivated you to get involved and take on the responsibilities of these organizational roles, and are you currently holding any positions?

I feel my skills are strong when it comes to dealing with people, in the sense of promoting a cooperative attitude and respecting everyone. I treat people with respect, the way I want to be treated myself. I think people truly respond to that, and you can really move an organization forward when you get cooperation that comes from an environment of respect. I think one of my strengths is getting a board together behind common-ground, white-hat issues that are going to help patients and our society. Having these skills and wanting to excel in the field is what motivated me to take these leadership positions.

I am now the president-elect of the American Society for Laser Medicine and Surgery. I plan to help that society grow and increase the membership as I have with the other societies. It’s fun to have a larger influence than just in your own office and to be able to help colleagues and create educational opportunities. It’s a labor of love and it becomes very gratifying.