Кто-нибудь из интервенционистов занимается установкой клапанов?
http://www.ctsnet.org/sections/innovati ... cle-6.html
Клапаны перкутанно интревенционистами.
Модератор: Pyankov Vasily
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Igor Bulatov
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Максим Осипов
- Сообщения: 1028
- Зарегистрирован: Пт мар 23, 2007 6:42 pm
- Откуда: Таруса, Москва
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Igor Bulatov
- Сообщения: 1232
- Зарегистрирован: Сб апр 21, 2007 3:31 am
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Igor Bulatov
- Сообщения: 1232
- Зарегистрирован: Сб апр 21, 2007 3:31 am
В качестве примера-сегодняшний пациент,5 летний ребенок,родившийся с атрезией аортального клапана,большим дефектом межжелудочковой перегородки.В возрасте 2 дней произведена операция Norwood stage 1 (modified),которая предполагает реконструкцию аорты (в данном случае клапанным легочным гомогомографтом)и правожелудочково-в левую легочную артерию кондуитом (клапанный гомографт легочной артерии,соединенный с Gore-tex).
В возрасте 8 месяцев-операция Растелли/Росс,в результате которой была восстановлена бивентрикулярная физиология.Естественный легочной клапан был перемещен н неоаорту (результат Норвуда),а легочной клапан замещен легочным гомографтом.
В возрасте 4.5 лет выполнена балонная легочная валвулопластика.В настояще время-moderate to severe недостаточность легочного клапана.
Сегодня-перкутанная установка легочного клапана.
Результат-полное восстановление анатомии сердца с хорошей функцией клапанов сердца,включая аортальный и легочный.
В возрасте 8 месяцев-операция Растелли/Росс,в результате которой была восстановлена бивентрикулярная физиология.Естественный легочной клапан был перемещен н неоаорту (результат Норвуда),а легочной клапан замещен легочным гомографтом.
В возрасте 4.5 лет выполнена балонная легочная валвулопластика.В настояще время-moderate to severe недостаточность легочного клапана.
Сегодня-перкутанная установка легочного клапана.
Результат-полное восстановление анатомии сердца с хорошей функцией клапанов сердца,включая аортальный и легочный.
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Максим Осипов
- Сообщения: 1028
- Зарегистрирован: Пт мар 23, 2007 6:42 pm
- Откуда: Таруса, Москва
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AUdovichenko
- Сообщения: 122
- Зарегистрирован: Вс апр 01, 2007 2:15 pm
- Откуда: ММА им. И.М. Сеченова
Уважаемый Игорь Булатов!
Мне кажется, FDA пока не разрешала рутинное использование чрезкожной установки клапанов? Ваш центр имеет лицензию на исследовательскую деятельность в медицине?
Что касается России, насколько я знаю - пока не было ни одного случая чрезкожной имплантации аортального клапана. Неоднократно видела эту манипуляцию на крупных интервенциологических съездах (в Европе)- впечатление двоякое... С одной стороны, не надо АИК и всего остального, сопряженного с большой кардиохирургией. С другой стороны, результаты пока что... Скажем так, требуют доработки
Мне кажется, FDA пока не разрешала рутинное использование чрезкожной установки клапанов? Ваш центр имеет лицензию на исследовательскую деятельность в медицине?
Что касается России, насколько я знаю - пока не было ни одного случая чрезкожной имплантации аортального клапана. Неоднократно видела эту манипуляцию на крупных интервенциологических съездах (в Европе)- впечатление двоякое... С одной стороны, не надо АИК и всего остального, сопряженного с большой кардиохирургией. С другой стороны, результаты пока что... Скажем так, требуют доработки
Анна Евгеньевна Удовиченко
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Igor Bulatov
- Сообщения: 1232
- Зарегистрирован: Сб апр 21, 2007 3:31 am
http://www.scai.org/pdf/AR_12-04_SCAI_Brodsky.pdf
http://circ.ahajournals.org/cgi/content ... /113/6/842
http://www.ctsnet.org/sections/innovati ... le-26.html
Medical Procedure News
Published: Monday, 5-Sep-2005
http://www.news-medical.net/?id=12955
Percutaneous aortic valve replacement is becoming a reality and brings new hope for a number of patients who cannot currently be treated with traditional surgical techniques.
Whereas surgical valve replacement concerns about 200,000 patients worldwide every year, it is estimated that between 1/3 (Iung et al, Euro Heart Survey, 2003) and 2/3 (Rambas Pai, USC AHA 2004) of patients do not receive surgery due to either excessive risk factors and comorbidities or patient refusal due to fear of lifestyle changes following heavy surgery in elderly patients. The size of this untreated cohort is expected to increase, reflecting the aging population. However, without replacing the valve, the disease is associated with a very high mortality rate (50 to 60% at one year) beyond the onset of symptoms. The goal of the percutaneous valve is to bring a less invasive therapeutic solution for these patients.
The Cribier-Edwards Percutaneous valve (Edwards Lifesciences, Irvine, Cal, USA) is a bioprosthesis made of three leaflets of equine pericardium sutured to a balloon expandable stainless steel stent. After balloon predilatation of the native valve, this bioprosthesis is crimped over a balloon catheter, and advanced over a stiff guidewire through the vessels (either from the femoral vein -antegrade/transseptal approach- or the femoral artery -retrograde approach-) up to the diseased fibro-calcific native aortic valve, using regular cardiac catheterization techniques. The bioprosthesis is then released by balloon inflation at mid-part of the native valve. In our institution, the technique is performed under local anesthesia and light sedation.
In our experience, the procedure (which first case was performed in April 2002) remains under investigation and implantations are strictly restricted to compassionate cases in patients who have been formally declined by two cardiac surgeons due to severe associated comorbidities. We have enrolled 40 patients to date in two single centre feasibility studies (the I-REVIVE and the RECAST studies). Three patients have now reached two years of follow-up. The valve performance has been excellent and there has not been a single case of valve failure when the valve was successfully placed (80% of the cases). High mortality during follow-up has been related to non valvular causes, mainly the evolution of life-threatening comorbidities.
Challenges remain as the procedure is complex when performed via the antegrade/transseptal route, whereas the less demanding retrograde route has been frequently associated with failures in crossing the native valve. Also, paravalvular leaks can occur (moderate to severe in 25%), which is undesirable despite not being a clinical issue. One reason for the leak has been to have a single valve size (23mm in diameter), too small for some patients.
Two most recent developments relate to a custom retrograde delivery system, as well as a larger 26mm size valve. Dr John Webb (Vancouver, Canada) is the only physician approved yet for investigating these new iterations. He has successfully performed a number of cases using the custom retrograde delivery system and the 26mm valve. The retrograde route is much simpler and can be performed in about one hour. The rate and severity of paravalvular leak has dramatically decreased with the use of the 26mm valve.
Two multicentre studies have just begun enrollment in Europe (REVIVE trial) and the US (REVIVAL trial) that will help to determine the future of this revolutionary and promising interventional cardiology procedure.
http://circ.ahajournals.org/cgi/content ... /113/6/842
http://www.ctsnet.org/sections/innovati ... le-26.html
Medical Procedure News
Published: Monday, 5-Sep-2005
http://www.news-medical.net/?id=12955
Percutaneous aortic valve replacement is becoming a reality and brings new hope for a number of patients who cannot currently be treated with traditional surgical techniques.
Whereas surgical valve replacement concerns about 200,000 patients worldwide every year, it is estimated that between 1/3 (Iung et al, Euro Heart Survey, 2003) and 2/3 (Rambas Pai, USC AHA 2004) of patients do not receive surgery due to either excessive risk factors and comorbidities or patient refusal due to fear of lifestyle changes following heavy surgery in elderly patients. The size of this untreated cohort is expected to increase, reflecting the aging population. However, without replacing the valve, the disease is associated with a very high mortality rate (50 to 60% at one year) beyond the onset of symptoms. The goal of the percutaneous valve is to bring a less invasive therapeutic solution for these patients.
The Cribier-Edwards Percutaneous valve (Edwards Lifesciences, Irvine, Cal, USA) is a bioprosthesis made of three leaflets of equine pericardium sutured to a balloon expandable stainless steel stent. After balloon predilatation of the native valve, this bioprosthesis is crimped over a balloon catheter, and advanced over a stiff guidewire through the vessels (either from the femoral vein -antegrade/transseptal approach- or the femoral artery -retrograde approach-) up to the diseased fibro-calcific native aortic valve, using regular cardiac catheterization techniques. The bioprosthesis is then released by balloon inflation at mid-part of the native valve. In our institution, the technique is performed under local anesthesia and light sedation.
In our experience, the procedure (which first case was performed in April 2002) remains under investigation and implantations are strictly restricted to compassionate cases in patients who have been formally declined by two cardiac surgeons due to severe associated comorbidities. We have enrolled 40 patients to date in two single centre feasibility studies (the I-REVIVE and the RECAST studies). Three patients have now reached two years of follow-up. The valve performance has been excellent and there has not been a single case of valve failure when the valve was successfully placed (80% of the cases). High mortality during follow-up has been related to non valvular causes, mainly the evolution of life-threatening comorbidities.
Challenges remain as the procedure is complex when performed via the antegrade/transseptal route, whereas the less demanding retrograde route has been frequently associated with failures in crossing the native valve. Also, paravalvular leaks can occur (moderate to severe in 25%), which is undesirable despite not being a clinical issue. One reason for the leak has been to have a single valve size (23mm in diameter), too small for some patients.
Two most recent developments relate to a custom retrograde delivery system, as well as a larger 26mm size valve. Dr John Webb (Vancouver, Canada) is the only physician approved yet for investigating these new iterations. He has successfully performed a number of cases using the custom retrograde delivery system and the 26mm valve. The retrograde route is much simpler and can be performed in about one hour. The rate and severity of paravalvular leak has dramatically decreased with the use of the 26mm valve.
Two multicentre studies have just begun enrollment in Europe (REVIVE trial) and the US (REVIVAL trial) that will help to determine the future of this revolutionary and promising interventional cardiology procedure.
-
Igor Bulatov
- Сообщения: 1232
- Зарегистрирован: Сб апр 21, 2007 3:31 am
J Am Coll Cardiol, 2004; 44:1662-1663, doi:10.1016/j.jacc.2004.07.025
© 2004 by the American College of Cardiology Foundation
http://content.onlinejacc.org/cgi/conte ... /44/8/1662
EDITORIAL COMMENT
Percutaneous valve replacement and repair
Fiction or reality?*
Igor F. Palacios, MD, FACC*
Cardiac Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts
* Reprint requests and correspondence: Dr. Igor F. Palacios, Director, Cardiac Catheterization Laboratories, Director of Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts 02114 (Email: palacios.igor@mgh.harvard.edu).
--------------------------------------------------------------------------------
Greater advances in the use of percutaneous techniques for the treatment of coronary artery disease and cardiac non-coronary interventions have occurred during the last few years. Among them, percutaneous techniques for the treatment of stenotic valvular lesions were developed, and their benefits were demonstrated in the treatment of most patients with pulmonary stenosis, rheumatic mitral stenosis, and tricuspid stenosis and in some patients with non-calcific aortic stenosis (1,2). Even as percutaneous catheter approaches may be the procedure of choice for most patients with rheumatic mitral stenosis, they certainly are not for most elderly patients with calcific aortic stenosis (1,2). Although percutaneous techniques are the procedure of choice for the treatment of most stenotic valvular lesions, open heart surgery with valve replacement or repair is the only therapeutic alternative for the treatment of patients with symptomatic regurgitant valve lesions and for patients with calcific aortic stenosis (1–3).
Hundreds of thousands of patients in the U.S., including a large share of patients with congestive heart failure, might benefit from heart valve repair or replacement. To date, the surgical approach is the only option available for cardiac valve replacement. It is expected that >300,000 patients will undergo heart valve surgery in 2004 despite its invasiveness, risk, and cost. However, valve replacement has limitations, such as surgical mortality, high-risk patient subgroups, chronic anticoagulation, postoperative recovery, and late failure of bioprosthetic valves.
The future of percutaneous valve repair and replacement depends on the development of collapsible and compressible valve prostheses, transcatheter valve repair technologies, anti-calcification treatment, and innovative valve suturing technologies. An integration of known technologies, including balloon-expandable technology, balloon technology for predilation and deployment, and bi- or tri-leaflet heart valve designs made from polymer or biologic material have the potential to help in the development of percutaneous techniques for the treatment of regurgitant lesions. We can dream of an ideal valve for percutaneous placement. This valve should be available at variables sizes, should be biocompatible, and should have excellent intrinsic properties and low profile. Finally, this valve should be able to be sutured into an expandable stent without losing its properties after crimping and re-expansion. Recently, percutaneous transcatheter replacement of the pulmonic valve was introduced by Bonhoeffer et al. (4,5), and percutaneous valve replacement of calcific aortic stenosis was introduced by Cribier et al. (6,7).This pioneering work by these two investigators represents a milestone that opens a new era of interventional cardiology (4–7).
Mitral regurgitation is a common disease that is clinically significant because of its detrimental effect on left ventricular function. Mitral regurgitation causes volume overload of the left ventricle and results in a vicious cycle. Volume overload leads to remodeling, with left ventricular dilation and consequent left ventricular dysfunction. Left ventricular dilation also produces abnormalities of mitral valve support and enlargement of the mitral annulus, which by themselves lead to progressive worsening of mitral regurgitation. The mitral valve apparatus is a complex structure composed of the mitral annulus, the mitral valve leaflets, the chordae tendineae, the papillary muscles, and the supporting of the left ventricular wall, the aorta, and the left atrium walls. Disease processes affecting any one of these components may result in dysfunction of the mitral valve apparatus, prolapsing leaflets, and mitral regurgitation. Whatever the etiology of mitral regurgitation is, surgical mitral valve repair currently is the procedure of choice (3). Initial attempts at percutaneous mitral valve repair have recently been reported. Two procedures dealing with different components of the mitral valve apparatus have been reported; the edge-to-edge repair and mitral valve annuloplasty using a coronary sinus device (8,9). The surgical edge-to-edge repair has been shown to be an effective method for repairing either structurally or functionally deficient mitral valves. The catheter-based Evalve Cardiovascular Valve Repair System (CVRS; Evalve Inc., Redwood City, California) is the first successful percutaneous endovascular adaptation of this repair technique. The early clinical results with the Evalve CVRS are compelling. The phase I study of the Evalve cardiovascular repair system, Endovascular Valve Edge-to-Edge Repair Study (EVEREST I), is currently underway in the U.S. and will provide initial information on safety and feasibility of the procedure. Enrollment in the trial is ongoing, with the results for the first 10 patients presented at the American College of Cardiology's late-breaking clinical trial session (New Orleans, Louisiana, March 2004). The clip was safely deployed in all 10 patients without complications. A reduction in mitral regurgitation to 2 grades was achieved in seven patients. The clip was not released in the other three patients, who underwent elective surgery. Ongoing studies with this technology will help to refine the technique and establish what will most likely be an increasing clinical applicability (9).
Future studies also are indicated to evaluate the potential for adjunctive catheter-based annuloplasty systems. Minimally invasive or even percutaneous valve repair has gained more momentum in recent months. Several companies are working on attractive instrumentation and devices to achieve this goal. The knowledge of the anatomy and pathophysiology of the coronary sinus is an important prerequisite of such devices. Multiple endovascular indirect annuloplasty ("sinoplasty") systems as the one described by Maniu et al. (10) in this issue of the Journal are in preclinical development and also may offer adjunctive technology in the treatment of patients with significant mitral regurgitation. In this paper, the authors reported on the placement of a percutaneous mitral annuloplasty device that results in a significant reduction in the severity of functional mitral regurgitation associated with severe left ventricular dysfunction in a canine animal model of rapid pacing-induced heart failure with functional mitral regurgitation. Cinching of the device in the coronary sinus resulted in significant decrease in mitral annulus diameter, mitral regurgitation jet area, and mitral regurgitation jet area-to-left atrium area ratio. This technique capitalizes on the relationship of the coronary sinus to the mitral annulus.
Nevertheless, there are some limitations in this study, such as the use of a single model of functional mitral regurgitation. Also, the severity of mitral regurgitation was only modest. There is a need to apply this technique to other models of mitral regurgitation, such as those of ischemic mitral regurgitation. Furthermore, this device is placed in the coronary sinus, and the circumflex artery is an important surrounded structure of the coronary sinus. Therefore, it is important to determine whether this device could interfere with coronary blood flow, particularly in the circumflex artery. As described by the authors, the relationship between the circumflex and the coronary sinus varies, and there is potential for device-induced compression of the circumflex artery.
A dramatic change is expected to occur during the next decade as the emergence of transcatheter heart valve repair techniques significantly reduces the risk and cost associated with heart valve procedures. Animal and early human studies indicate that nonsurgical techniques to valve replacement and repair are feasible. These techniques already have been applied safely to humans with artificial pulmonary artery trunks. More recently results from the approach to aortic valve replacement and mitral valve repair in animals and humans are encouraging. Pulmonary valve replacement, aortic valve replacement, and emerging techniques for percutaneous mitral valve repair recently have opened new perspectives on transcatheter replacement and repair of cardiac valves. Thus, percutaneous valve replacement and repair is not fiction—it is a reality.
© 2004 by the American College of Cardiology Foundation
http://content.onlinejacc.org/cgi/conte ... /44/8/1662
EDITORIAL COMMENT
Percutaneous valve replacement and repair
Fiction or reality?*
Igor F. Palacios, MD, FACC*
Cardiac Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts
* Reprint requests and correspondence: Dr. Igor F. Palacios, Director, Cardiac Catheterization Laboratories, Director of Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts 02114 (Email: palacios.igor@mgh.harvard.edu).
--------------------------------------------------------------------------------
Greater advances in the use of percutaneous techniques for the treatment of coronary artery disease and cardiac non-coronary interventions have occurred during the last few years. Among them, percutaneous techniques for the treatment of stenotic valvular lesions were developed, and their benefits were demonstrated in the treatment of most patients with pulmonary stenosis, rheumatic mitral stenosis, and tricuspid stenosis and in some patients with non-calcific aortic stenosis (1,2). Even as percutaneous catheter approaches may be the procedure of choice for most patients with rheumatic mitral stenosis, they certainly are not for most elderly patients with calcific aortic stenosis (1,2). Although percutaneous techniques are the procedure of choice for the treatment of most stenotic valvular lesions, open heart surgery with valve replacement or repair is the only therapeutic alternative for the treatment of patients with symptomatic regurgitant valve lesions and for patients with calcific aortic stenosis (1–3).
Hundreds of thousands of patients in the U.S., including a large share of patients with congestive heart failure, might benefit from heart valve repair or replacement. To date, the surgical approach is the only option available for cardiac valve replacement. It is expected that >300,000 patients will undergo heart valve surgery in 2004 despite its invasiveness, risk, and cost. However, valve replacement has limitations, such as surgical mortality, high-risk patient subgroups, chronic anticoagulation, postoperative recovery, and late failure of bioprosthetic valves.
The future of percutaneous valve repair and replacement depends on the development of collapsible and compressible valve prostheses, transcatheter valve repair technologies, anti-calcification treatment, and innovative valve suturing technologies. An integration of known technologies, including balloon-expandable technology, balloon technology for predilation and deployment, and bi- or tri-leaflet heart valve designs made from polymer or biologic material have the potential to help in the development of percutaneous techniques for the treatment of regurgitant lesions. We can dream of an ideal valve for percutaneous placement. This valve should be available at variables sizes, should be biocompatible, and should have excellent intrinsic properties and low profile. Finally, this valve should be able to be sutured into an expandable stent without losing its properties after crimping and re-expansion. Recently, percutaneous transcatheter replacement of the pulmonic valve was introduced by Bonhoeffer et al. (4,5), and percutaneous valve replacement of calcific aortic stenosis was introduced by Cribier et al. (6,7).This pioneering work by these two investigators represents a milestone that opens a new era of interventional cardiology (4–7).
Mitral regurgitation is a common disease that is clinically significant because of its detrimental effect on left ventricular function. Mitral regurgitation causes volume overload of the left ventricle and results in a vicious cycle. Volume overload leads to remodeling, with left ventricular dilation and consequent left ventricular dysfunction. Left ventricular dilation also produces abnormalities of mitral valve support and enlargement of the mitral annulus, which by themselves lead to progressive worsening of mitral regurgitation. The mitral valve apparatus is a complex structure composed of the mitral annulus, the mitral valve leaflets, the chordae tendineae, the papillary muscles, and the supporting of the left ventricular wall, the aorta, and the left atrium walls. Disease processes affecting any one of these components may result in dysfunction of the mitral valve apparatus, prolapsing leaflets, and mitral regurgitation. Whatever the etiology of mitral regurgitation is, surgical mitral valve repair currently is the procedure of choice (3). Initial attempts at percutaneous mitral valve repair have recently been reported. Two procedures dealing with different components of the mitral valve apparatus have been reported; the edge-to-edge repair and mitral valve annuloplasty using a coronary sinus device (8,9). The surgical edge-to-edge repair has been shown to be an effective method for repairing either structurally or functionally deficient mitral valves. The catheter-based Evalve Cardiovascular Valve Repair System (CVRS; Evalve Inc., Redwood City, California) is the first successful percutaneous endovascular adaptation of this repair technique. The early clinical results with the Evalve CVRS are compelling. The phase I study of the Evalve cardiovascular repair system, Endovascular Valve Edge-to-Edge Repair Study (EVEREST I), is currently underway in the U.S. and will provide initial information on safety and feasibility of the procedure. Enrollment in the trial is ongoing, with the results for the first 10 patients presented at the American College of Cardiology's late-breaking clinical trial session (New Orleans, Louisiana, March 2004). The clip was safely deployed in all 10 patients without complications. A reduction in mitral regurgitation to 2 grades was achieved in seven patients. The clip was not released in the other three patients, who underwent elective surgery. Ongoing studies with this technology will help to refine the technique and establish what will most likely be an increasing clinical applicability (9).
Future studies also are indicated to evaluate the potential for adjunctive catheter-based annuloplasty systems. Minimally invasive or even percutaneous valve repair has gained more momentum in recent months. Several companies are working on attractive instrumentation and devices to achieve this goal. The knowledge of the anatomy and pathophysiology of the coronary sinus is an important prerequisite of such devices. Multiple endovascular indirect annuloplasty ("sinoplasty") systems as the one described by Maniu et al. (10) in this issue of the Journal are in preclinical development and also may offer adjunctive technology in the treatment of patients with significant mitral regurgitation. In this paper, the authors reported on the placement of a percutaneous mitral annuloplasty device that results in a significant reduction in the severity of functional mitral regurgitation associated with severe left ventricular dysfunction in a canine animal model of rapid pacing-induced heart failure with functional mitral regurgitation. Cinching of the device in the coronary sinus resulted in significant decrease in mitral annulus diameter, mitral regurgitation jet area, and mitral regurgitation jet area-to-left atrium area ratio. This technique capitalizes on the relationship of the coronary sinus to the mitral annulus.
Nevertheless, there are some limitations in this study, such as the use of a single model of functional mitral regurgitation. Also, the severity of mitral regurgitation was only modest. There is a need to apply this technique to other models of mitral regurgitation, such as those of ischemic mitral regurgitation. Furthermore, this device is placed in the coronary sinus, and the circumflex artery is an important surrounded structure of the coronary sinus. Therefore, it is important to determine whether this device could interfere with coronary blood flow, particularly in the circumflex artery. As described by the authors, the relationship between the circumflex and the coronary sinus varies, and there is potential for device-induced compression of the circumflex artery.
A dramatic change is expected to occur during the next decade as the emergence of transcatheter heart valve repair techniques significantly reduces the risk and cost associated with heart valve procedures. Animal and early human studies indicate that nonsurgical techniques to valve replacement and repair are feasible. These techniques already have been applied safely to humans with artificial pulmonary artery trunks. More recently results from the approach to aortic valve replacement and mitral valve repair in animals and humans are encouraging. Pulmonary valve replacement, aortic valve replacement, and emerging techniques for percutaneous mitral valve repair recently have opened new perspectives on transcatheter replacement and repair of cardiac valves. Thus, percutaneous valve replacement and repair is not fiction—it is a reality.
-
AUdovichenko
- Сообщения: 122
- Зарегистрирован: Вс апр 01, 2007 2:15 pm
- Откуда: ММА им. И.М. Сеченова
Игорь, я и сама могу накидать ссылок про чрезкожную имплантацию аортального клапана - если нужно, нет проблем.
Вот эта ссылочка, например http://www.medscape.com/viewarticle/552091, очень хороша...
В частности, там приводится цифра "procedural failures" - 12% (6 из 50 пациентов). Да и смертность, хотя и существенно ниже ожидаемой у данной популяции больных, но, все же, тоже довольно-таки высокая - еще 12%.
Поверьте мне, пусть я и "маленький" интервенциолог, но появление любой новой интервенционной методики меня только радует... Только вот хотелось бы, чтобы эта самая методика была бы уже усовершенствована настолько, чтобы с ней не страшно было работать
И, кстати, Вы так и не ответили на мой вопрос: FDA уже разрешала рутинное использование чрезкожной установки клапанов?
Вот эта ссылочка, например http://www.medscape.com/viewarticle/552091, очень хороша...
В частности, там приводится цифра "procedural failures" - 12% (6 из 50 пациентов). Да и смертность, хотя и существенно ниже ожидаемой у данной популяции больных, но, все же, тоже довольно-таки высокая - еще 12%.
Поверьте мне, пусть я и "маленький" интервенциолог, но появление любой новой интервенционной методики меня только радует... Только вот хотелось бы, чтобы эта самая методика была бы уже усовершенствована настолько, чтобы с ней не страшно было работать
И, кстати, Вы так и не ответили на мой вопрос: FDA уже разрешала рутинное использование чрезкожной установки клапанов?
Анна Евгеньевна Удовиченко
-
Igor Bulatov
- Сообщения: 1232
- Зарегистрирован: Сб апр 21, 2007 3:31 am
FDA много чего не разрешает,что делается.С имплантируемыми клапанами и другими экспериментальными технологиями вопрос решается в каждом конкретном случае отдельно,на уровне госпиталя.Госпиталю для этого никакой лицензии не надо.Все зависит от уровня квалификации и подготовки доктора-оператора.Как и везде в медицине:в одних руках результаты лучше,в других...Технология же совершенствуется быстро.Не так давно и device closure дефектов межпредсердной перегородки и PDA были экспериментальными.А сейчас дефекты межпредсердной перегородки хирургически закрываются очень редко.
В Росии имеется огромное количество пациентов с приобретенными (ревматизм,эндокардит)клапанными пороками.
Хирургическое лечение для большинства из них-нечто из области фантастики.В основном,из за острой нехватки квалифицированных кардиохирургов.Перкутанное замещение клапанов может быть альтернативой для многих из них.Тем более,что технология уже существует.Которая быстро совершенствуется.Когда FDA разрешит рутинное применение перкутанного замещения клапанов,цены на них повысятся и станут недоступными для российского потребителя.Пока технология находится в экспериментальной стадии,компании -производители имплантируемых клапанов ищут любую возможность для более частого их использования и усовершентвования технических характеристик.
В Росии имеется огромное количество пациентов с приобретенными (ревматизм,эндокардит)клапанными пороками.
Хирургическое лечение для большинства из них-нечто из области фантастики.В основном,из за острой нехватки квалифицированных кардиохирургов.Перкутанное замещение клапанов может быть альтернативой для многих из них.Тем более,что технология уже существует.Которая быстро совершенствуется.Когда FDA разрешит рутинное применение перкутанного замещения клапанов,цены на них повысятся и станут недоступными для российского потребителя.Пока технология находится в экспериментальной стадии,компании -производители имплантируемых клапанов ищут любую возможность для более частого их использования и усовершентвования технических характеристик.
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AUdovichenko
- Сообщения: 122
- Зарегистрирован: Вс апр 01, 2007 2:15 pm
- Откуда: ММА им. И.М. Сеченова
Не могу не согласитьсяIgor Bulatov писал(а):FDA много чего не разрешает,что делается.С имплантируемыми клапанами и другими экспериментальными технологиями вопрос решается в каждом конкретном случае отдельно,на уровне госпиталя.Госпиталю для этого никакой лицензии не надо.Все зависит от уровня квалификации и подготовки доктора-оператора.Как и везде в медицине:в одних руках результаты лучше,в других...
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А вот с этим не могу согласитьсяВ Росии имеется огромное количество пациентов с приобретенными (ревматизм,эндокардит)клапанными пороками.
Хирургическое лечение для большинства из них-нечто из области фантастики.В основном,из за острой нехватки квалифицированных кардиохирургов.Перкутанное замещение клапанов может быть альтернативой для многих из них.
Причина проста - цена. В Европе, по-моему, есть какой-то вариант аортального клапана-стента, который получил CE-mark. Но стоимость его, если я ничего не путаю, составляет что-то около 15 000 Евро. Это без учета дополнительных расходных материалов и затрат на госпитализацию, наркоз (22 - 24 F - только артериосекция) и т.п. Хирургия в России получается куда как дешевле (операция имплантации клапана стоит порядка 6 000 USD без учета протеза, цена протеза - 2 000 USD).Так что не все так однозначно, с какой стороны не посмотри...
Анна Евгеньевна Удовиченко
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Igor Bulatov
- Сообщения: 1232
- Зарегистрирован: Сб апр 21, 2007 3:31 am
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AUdovichenko
- Сообщения: 122
- Зарегистрирован: Вс апр 01, 2007 2:15 pm
- Откуда: ММА им. И.М. Сеченова
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Igor Bulatov
- Сообщения: 1232
- Зарегистрирован: Сб апр 21, 2007 3:31 am
Я частенько получаю е-mail с одним и тем же вопросом:сколько стоит та или иная операция или процедура в США?Не знаю!И не уверен,что кто-нибудь сможет дать точный ответ.Предварительная стоимость может быть лишь приблизительной и варьировать в пределах нескольких десятков тысяч в зависимости от состояния пациента до и после операции,необходимого лечения и т.д.
Хочу,однако,понять систему оплаты кардиохирургических операций vs интевенционных процедур в России.На сколько я знаю,существует система квот на бесплатное лечение.Если пациент попадает в такую квоту,то лечение покрывается медицинской страховкой.Покрывается ли операция по замене клапана?Кто платит за клапан и за "расходные материалы"?Кстати,что это такое?Кто платит за стенты,pacemakers?Страховка,пациент или вместе?
Если пациент,предположим,приходит по скорой помощи на катетеризацию сердца и ему показано введение одного или нескольких стентов.Как и когда решается вопрос об их установке?Немедленно,без вопросов?Или после того,как родственники внесли необходимую сумму в кассу?
Хочу,однако,понять систему оплаты кардиохирургических операций vs интевенционных процедур в России.На сколько я знаю,существует система квот на бесплатное лечение.Если пациент попадает в такую квоту,то лечение покрывается медицинской страховкой.Покрывается ли операция по замене клапана?Кто платит за клапан и за "расходные материалы"?Кстати,что это такое?Кто платит за стенты,pacemakers?Страховка,пациент или вместе?
Если пациент,предположим,приходит по скорой помощи на катетеризацию сердца и ему показано введение одного или нескольких стентов.Как и когда решается вопрос об их установке?Немедленно,без вопросов?Или после того,как родственники внесли необходимую сумму в кассу?