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Steam Technology Appears Promising
SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.
"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.
Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.
Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.
Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.
The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.
Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.
All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.
The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.
Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.
Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.
Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.
If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.
In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.
The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.
Depending on how the studies pan out, I
think steam endovascular ablation is going to be cheaper for physicians
because it utilizes steam and not laser or expensive fiber. Secondly, I
think it's going to be just as effective, and it's going to be a lot
quicker. Less time in the OR translates into a procedure that's going to
be cheaper for patients. Because of all those reasons, it's going to
give the current technology a run for its money.
By Dr. Margaret W. Mann |
Currently, with our laser fibers, one of the difficulties is that the
fiber is fairly rigid. Tortuous veins can be difficult to get to. I
haven't personally seen the steam device yet, but from videos that I
have seen, it does appear to be much more flexible. You can easily feed
it into a vein that is tortuous.
The first-generation radiofrequency device was somewhat flexible,
but the second-generation device, which is faster, is somewhat rigid.
You can only really treat the great saphenous vein, but for tributaries
and for really tortuous veins, you are not able to treat. I think you
really can do it with steam.
In my experience, I'd say 80%-90% of the time, it's fairly easy to
feed the laser or radiofrequency device into these veins. For that
5%-10% of the time that it’s difficult, however, I think this will be
advantageous.
In the pilot study of 20 patients, the success rate was about
60%-70%. That certainly is much lower than what we are accustomed to
with laser and radiofrequency. Success rates are about 95% with laser
and about 89% with radiofrequency devices. However, investigators are
still trying to figure out the best energy delivery, how many pulses of
steam are necessary. I think if they do some more tinkering with it, and
graph the optimal energy, they're going to get better results
Based on the pilot study, would I go out and
purchase this and use it on my patients? No, but I think if they get
more effective results, then, it's going to be a great technology.
There are several advantages I see with this compared with the other
devices: With laser, you create carbonization on the laser fiber tip,
which leads to less uniform heating. You also have to wear safety
glasses, and there's the potential that this rigid fiber can perforate
vein walls. With the radiofrequency device, it's a slower process. It
takes at least 20-30 minutes or longer to close the vein. And the
catheter is quite expensive. With sclerotherapy, there's always the
possibility of an allergic reaction and potential for the foam bubbles
to go through the patent foraminal valley and cause some sort of
neurologic deficit.
You eliminate all those disadvantages with the steam system.
The technology is a novel but quite simple idea, and I think patients
will understand that and may prefer it to the other modalities.
Dr. Mann is co-director of dermatologic surgery and chief
of clinical services in dermatology at the University of California,
Irvine. She has been a consultant to Merz Aesthetics, which markets a sclerotherapy product.
Depending on how the studies pan out, I
think steam endovascular ablation is going to be cheaper for physicians
because it utilizes steam and not laser or expensive fiber. Secondly, I
think it's going to be just as effective, and it's going to be a lot
quicker. Less time in the OR translates into a procedure that's going to
be cheaper for patients. Because of all those reasons, it's going to
give the current technology a run for its money.
By Dr. Margaret W. Mann |
Currently, with our laser fibers, one of the difficulties is that the
fiber is fairly rigid. Tortuous veins can be difficult to get to. I
haven't personally seen the steam device yet, but from videos that I
have seen, it does appear to be much more flexible. You can easily feed
it into a vein that is tortuous.
The first-generation radiofrequency device was somewhat flexible,
but the second-generation device, which is faster, is somewhat rigid.
You can only really treat the great saphenous vein, but for tributaries
and for really tortuous veins, you are not able to treat. I think you
really can do it with steam.
In my experience, I'd say 80%-90% of the time, it's fairly easy to
feed the laser or radiofrequency device into these veins. For that
5%-10% of the time that it’s difficult, however, I think this will be
advantageous.
In the pilot study of 20 patients, the success rate was about
60%-70%. That certainly is much lower than what we are accustomed to
with laser and radiofrequency. Success rates are about 95% with laser
and about 89% with radiofrequency devices. However, investigators are
still trying to figure out the best energy delivery, how many pulses of
steam are necessary. I think if they do some more tinkering with it, and
graph the optimal energy, they're going to get better results
Based on the pilot study, would I go out and
purchase this and use it on my patients? No, but I think if they get
more effective results, then, it's going to be a great technology.
There are several advantages I see with this compared with the other
devices: With laser, you create carbonization on the laser fiber tip,
which leads to less uniform heating. You also have to wear safety
glasses, and there's the potential that this rigid fiber can perforate
vein walls. With the radiofrequency device, it's a slower process. It
takes at least 20-30 minutes or longer to close the vein. And the
catheter is quite expensive. With sclerotherapy, there's always the
possibility of an allergic reaction and potential for the foam bubbles
to go through the patent foraminal valley and cause some sort of
neurologic deficit.
You eliminate all those disadvantages with the steam system.
The technology is a novel but quite simple idea, and I think patients
will understand that and may prefer it to the other modalities.
Dr. Mann is co-director of dermatologic surgery and chief
of clinical services in dermatology at the University of California,
Irvine. She has been a consultant to Merz Aesthetics, which markets a sclerotherapy product.
Depending on how the studies pan out, I
think steam endovascular ablation is going to be cheaper for physicians
because it utilizes steam and not laser or expensive fiber. Secondly, I
think it's going to be just as effective, and it's going to be a lot
quicker. Less time in the OR translates into a procedure that's going to
be cheaper for patients. Because of all those reasons, it's going to
give the current technology a run for its money.
By Dr. Margaret W. Mann |
Currently, with our laser fibers, one of the difficulties is that the
fiber is fairly rigid. Tortuous veins can be difficult to get to. I
haven't personally seen the steam device yet, but from videos that I
have seen, it does appear to be much more flexible. You can easily feed
it into a vein that is tortuous.
The first-generation radiofrequency device was somewhat flexible,
but the second-generation device, which is faster, is somewhat rigid.
You can only really treat the great saphenous vein, but for tributaries
and for really tortuous veins, you are not able to treat. I think you
really can do it with steam.
In my experience, I'd say 80%-90% of the time, it's fairly easy to
feed the laser or radiofrequency device into these veins. For that
5%-10% of the time that it’s difficult, however, I think this will be
advantageous.
In the pilot study of 20 patients, the success rate was about
60%-70%. That certainly is much lower than what we are accustomed to
with laser and radiofrequency. Success rates are about 95% with laser
and about 89% with radiofrequency devices. However, investigators are
still trying to figure out the best energy delivery, how many pulses of
steam are necessary. I think if they do some more tinkering with it, and
graph the optimal energy, they're going to get better results
Based on the pilot study, would I go out and
purchase this and use it on my patients? No, but I think if they get
more effective results, then, it's going to be a great technology.
There are several advantages I see with this compared with the other
devices: With laser, you create carbonization on the laser fiber tip,
which leads to less uniform heating. You also have to wear safety
glasses, and there's the potential that this rigid fiber can perforate
vein walls. With the radiofrequency device, it's a slower process. It
takes at least 20-30 minutes or longer to close the vein. And the
catheter is quite expensive. With sclerotherapy, there's always the
possibility of an allergic reaction and potential for the foam bubbles
to go through the patent foraminal valley and cause some sort of
neurologic deficit.
You eliminate all those disadvantages with the steam system.
The technology is a novel but quite simple idea, and I think patients
will understand that and may prefer it to the other modalities.
Dr. Mann is co-director of dermatologic surgery and chief
of clinical services in dermatology at the University of California,
Irvine. She has been a consultant to Merz Aesthetics, which markets a sclerotherapy product.
Steam Technology Appears Promising
Steam Technology Appears Promising
SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.
"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.
Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.
Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.
Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.
The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.
Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.
All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.
The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.
Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.
Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.
Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.
If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.
In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.
The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.
SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.
"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.
Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.
Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.
Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.
The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.
Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.
All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.
The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.
Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.
Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.
Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.
If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.
In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.
The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.
FROM THE WORLD CONGRESS OF DERMATOLOGY
Major Finding: At 6 months' follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.
Data Source: The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients.
Disclosures: Dr. Neumann declared having no relevant financial relationships. Dr. Mann has been a consultant to Merz Aesthetics, which markets a sclerotherapy product.