Monday, March 13, 2006

History of angioplasty in Malaysia - Final part

Here we wrap up the history of angioplasty in Malaysia. It runs five parts with parts 1, 2, 3 and 4 coming before.

After returning from Paris, I continue with POBA while making enquiries about how to get access to stents. All the other devices tried then did not seem to be safe or effective enough. I wasn't particularly impressed with any of them so we never explored using them.

God, overtime, my instinct and basic deductions (including numerous corridor talk with the "sifus" - masters) were proven correct. The other devices including the lasers and the rotacs, and the DVI cutters fell by the wayside, one by one, or became niche devices.

The stent stayed and established her position in PCI. Back in 1990, there were three stents being tried. The first was the self-expanding Wall stent (Schneider). The second stent available was the Giantarco-Rubin stent (Cooks). The Rubin in that is Gary Rubin. These two stents were wire coil stents, allowing great flexibility, meaning it was easy to implant, but they were rather weak and had very poor hoop strength, which meant that they had a high risk of re-stenosis. This actually turned out to be true. We no longer use these stents are they are probably not available anymore.

I was very impressed with the tubular, wire mesh Palmaz-Schaltz (JnJ) stent. This stent was rigid, had strong hoop strength and was closed cell. This means that they were difficult to implant (you need great skill to put them down), but had good results. This was the stent that I saw implanted in Toulose, with such good post-procedural results. I got in touch with JnJ to see how we could get our our hands on the PS stent.

There was no sales team in Malaysia at that time. This was 1990. With a stroke of luck, the regional manager handling this PS stent was a lady call Mdm Chyio Imai, a very pleasant lady whom I had got to know in 1998 when I was trying to arrange for the study trip to San Francisco (you remember, part 2). At that time Mdm Imai was working in Cordis Corporation and it was she who gave us help to fund one of our Government service cardiologist's trip to San Francisco. By 1990, she had joined JnJ Japan. She arranged for me to meet with Dr Richard Schaltz, the founder of the stent, who was working at Scripps La Jolla. Dr Schaltz was kind enough to be a friend and agreed to allow me to use the PS stent.

Bear in mind that this stent was not yet FDA approved. Due to the the strict ethics of JnJ, I was asked to undergo proctoring at the nearest center implanting the stent. So off I went to Kokura, in Kita-Kyushu, Japan. The Head of Interventional Cardiology at Kokura Memorial Hospital then was Dr Masakiyo Noboyushi. Mdm Imai again was kind enough to arrange for a meeting with Dr Noboyushi one cold autumn night on the fringe of the American Heart Association Annual Scientific meeting in Nov. 1990. Dr Noboyushi agreed to have me. Through the offices of JnJ, I went to Kokura in March 1991 to work with Noboyushi. After about 2 weeks in Kokura, I returned.

Upon my return, I was asked to sign a declaration that I would agree to become an FDA co-investigator in the use of the PS stent. The stents were then sold to me personally (as I was the co-investigator) . At the time, the medical center that I worked for did not want to buy the stents as they are not sure it would do well. I remember having to buy the stents with my own money, storing it in my office and bringing the whole lot to the cath lab each time I had to use one.

At the time, the PS stent came with a 5F stent delivery system, and the stent was loosely mounted on. This PS-SDS was an OTW system and it fitted tightly into an 8F guiding catheter. Can you imagine the difficulty trying to move a long 5F system in to the Left Circumflex coronary artery, using an 8F system? Indeed those were the days. I always say nowadays, the young boys have it easy. If you can pass an 8F system down in 1991, you can pass any of the fancy 2.5F system currently available, anywhere.

About April of 1991, I saw a 60+yrs lady, Mdm L, who complained of angina, whenever she got excited, gambling in the Genting casino. The stress ECG was obviously positive, and she was diabetic. I studied her and she had a tight lesion in the proximal RCA. The rest of the coronary tree was fine. I spoke to her and her family about angioplasty and the new stents that I had, that were still under investigations, but whose results in the USA were outstanding. It helped to lessen the risk of emergency surgery too. They agreed and the angioplasty was scheduled for 13th May 1991. I'm pretty sure that being a gambler had nothing to do with the decision!!!

She was admitted on 12th May 1991, and the angioplasty was scheduled for 9am on 13th May 1991. Everything went according to plan and the PS-SDS went down smoothly through an 8F Amplatz guide. Post stent regime then included 40% Dextran as anti-thrombosis, the patient was kept on heparin and started on warfarin and aspirin. She bled a little at the groin site. Otherwise the whole hospitalisation was about 3 days and uneventful.

We continue to implant the PS stent and went regularly to the AHA annual scientific meeting, the autumn meeting, to meet with the "sifus (experts) and Richard" and discuss our experience so that we could all get up to speed as fast as possible. By 1994, the STRESS and BENESTENT clinical trials of POBA Vs PS stent showed clearly that the PS stent was clearly superior to POBA in terms of less restenosis, less target lesion revascularisation and less need for emergency bypass surgery.

We presented our own experience in 1997, at the Academy of Medicine annual scientific meeting, of our first 125 patients with at least six months followup (82% clinical follow-up), with a 7.2% clinical restenosis. The PS stent was FDA approved in 1994. By then we already had considerable experience. In fact in June 1992, I was invited to Beijing (Fu Wai Cardiovascular Institute) by Prof. Goa, to show them the use of the PS stent. They only had exposure to the Gianturco-Rubin stent. This too went well. Once the PS was approved, we began to get stocks of bare-metal PS stents which we could self hand crimp onto the balloon and deliver "naked" to the lesion. This was sometimes scary.

As we did with POBA since October 1998, and also with the PS stent since May 13th, 1991, we kept complete registries and follow-up survellience to make sure that all was well. Of course, by 1997, many other interventionist had returned from overseas and others had trained themselves locally. Stents underwent tremendous improvements. They are so slick nowadays that they are sometimes implanted with impunity and a certain degree of carelessness.

From 1997 onwards, PCI took her own route. The journey continues well. My job here was done. Angioplasty has matured in Malaysia, it is alive and well.

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