WO2009141286A1

WO2009141286A1 - Method for treating heart diseases

Info

Publication number: WO2009141286A1
Application number: PCT/EP2009/055957
Authority: WO
Inventors: Van Den Cornelis Johannes Maria Berg
Original assignee: Van Den Cornelis Johannes Maria Berg
Priority date: 2008-05-19
Filing date: 2009-05-15
Publication date: 2009-11-26

Abstract

The invention is in the field of devices intended for the treatment of heart failure of any origin with a substrate in the heart, in particular for the treatment of coronary diseases and/or arterial diseases. More in particular, the invention provides an artificial valve that is suitable for temporarily or permanently residing in an artery, more in particular the descending aorta, even more in particular the descending aorta just after branching of the left subclavian artery. A device according to the invention may be advantageously employed in the treatment of decompensatio cordis. A device according to the invention may be employed even if the arterial vessels are stiff.

Description

METHOD FOR TREATING HEART DISEASES.

Field of the invention

The invention is in the field of methods for the treatment of heart failure of any origin with a substrate in the heart and devices used therein, in particular for the treatment of coronary diseases and/or arterial diseases. More in particular the invention provides artificial valves suitable for permanently or temporarily residing in an artery, more in particular the descending aorta, even more in particular the descending aorta just after branching of the left subclavian artery. A device according to the invention may be advantageously employed in the treatment of congestive heart failure or decompensatio cordis. A device according to the invention may be employed even if the arterial vessels are stiff.

Background of the invention Nowadays artificial valves (mechanical or biological) are exclusively applied for replacing a malfunctioning heart valve. Such valves are usually inserted surgically. Recently, artificial valves have been described that may be implanted percutaneously.

Also, vascular valves for placement in smaller veins or arteries have been described. Vascular valves for placement in the descending aorta have also been described. Such valves have also been described mounted on stents, albeit for temporary placement in the patient's body to overcome a period of acute detonation of decompensted heart failure. They are all catheter mounted, so they are prone to infections and thrombosis, can only reside a very limited period and make the patient bedridden and to be bound to an intensive cardiac care unit.

The valves described in the prior art are all prone to substantial paravalvular leakage so they cannot be used for investigational purposes that look after the properties of the aorta. Hence, their use as a device to lower afterload for the Left Ventricle will be very limited. There remains a need for an improved method to treat heart diseases as well as devices for use therein.

Summary of the invention

The invention relates to a method for the treatment of a disease selected from the group consisting of acute and chronic congestive heart failure, coronary diseases, arterial diseases, heart valve diseases, cardiomyopathic diseases, decompensatio cordis and asthma cardiale wherein an artificial valve is placed in the aorta descendens after the left subclavian artery.

Several devices may be envisaged for use in the invention as described herein. Such devices may be suitable for permanent placement in the patient. However, it can also be envisaged that a temporarily device is inserted. The temporarily placed device may also be used to determine whether the patient may benefit from the placement of a permanent device.

The invention also relates to an artificial valve mounted on a low gradient stent that can withstand the forces applied on it by the blood stream in the aorta descendens. When permanently placed, such a device may then be applied to a mobile patient and remain in the patient's body for a lifetime.

A permanent device according to the invention comprises a low gradient valve mounted on a stent equipped with means for anchoring the device at the appropriate place in the aorta descendens, such that it can withstand the blood pressure at that particular site. A particularly advantageous device is a stent comprising an outer surface as depicted in figure 1 . Such a device may be delivered percutaneously and transluminal^ and is non thrombogenic. This device provides structures that anchor the stent in the aorta descendens and prevent its migration, for instance by the blood flow in the aorta while resulting in minimal discomfort and adverse effects for the patient.. A temporary device may be designed as a balloon mounted on a catheter comprising a tricuspid valve. The balloon then anchors the device at the appropriate position, either for therapeutic or for diagnostic purposes.

Detailed description of the invention This invention relates to a method for the treatment of a disease selected from the group consisting of acute and chronic congestive heart failure, coronary diseases, arterial diseases, heart valve diseases, cardiomyopathic diseases, decompensatio cordis and asthma cardiale wherein an artificial valve is placed in the aorta descendens after the left subclavian artery. The term artificial valve is used herein to indicate a valve from a different origin as the species wherein it is to be inserted. In a preferred embodiment, an artificial valve is a mechanical valve, i.e. not from a biological origin.

A valve mounted in the aorta descendens shortly after branching of the left subclavian artery provides a means to reduce the intensity of reflection waves of the first and higher order reaching the aortic root. It also provides a means to reduce the intensity of aortic and distal arterial compliance effects reaching the aortic root and a means to reduce afterload and through that resulting in diminishing dyssynchrony within the left ventricle.

The valve in the method according to the invention may advantageously be a tricuspid valve.

The valve may be comprised in a temporary or a permanent device. A temporary device is characterized in that it contains elements for its removal from the human or animal body. A permanent device is characterized in that it consists of materials suitable for a long term stay in the human or animal body and/or the lack of means for its removal from the human or animal body.

In its simplest form, the permanent device is a cylindrical stent comprising a valve in its inner lumen whereas the temporary device is a hollow cylindrical balloon with a valve in its inner lumen.

A balloon may be mounted on a catheter in any conventional way, for instance using wires. Such a balloon which comprises a valve can also be used to investigate the properties of the aorta as a whole or segment by segment. The invention also relates to a device that provides a mechanical support that may be used to treat congestive heart failure. Placement of the device at its intended location leaves the diseased structure of the existing heart untouched. It is a mechanical support, which does not need the addition of external energy and may be applied both in the chronic and acute setting. The device according to the invention may be applied under conditions of heart failure whereas a disfunctioning heart valve is not mandatory.

The device may be applied to the human or animal body by percutaneous and transluminal insertion. It is also possible to implant the device using a surgical method. In the prior art, patients with severe chronic or acute heart failure are usually treated with drugs that may reduce the preload, reduce the afterload or strengthen the contraction force of the ventricle, without negatively influencing the coronary flow.

The term preload is known in the art and is used herein to indicate end diastolic wall stress which is best measured by the end-diastolic volume. The term afterload indicates the wall stress during ejection which is best measured by the systolic pressure of the left ventricle which has systolic blood pressure s a good measurable surrogate. The term contraction force indicates contractility which is the intrinsic strength of the ventricle, best measured by the end systolic elastance (Ees), the slope of the end-systolic pressure-volume relation (in PV-loops for varying filling pressures).

The preload depends on the filling pressure and the compliance of the ventricle in diastole.

Drug therapy with reduction of blood volume (ie diuretics, reducing pre-and afterload) and vasodilators (reducing afterload) are among the most commonly applied treatments. Intravenous drugs such as catecholamines are usually supplied in order to influence the contraction force. Such treatment however is only effective for a limited period of exacerbation, for instance during cardiac asthma.

Mechanical intervention is often the ultimate but also the most effective treatment. For better understanding of the therapies which are used in the mechanics of the heart but also to see the uniqueness of the invention, it is useful to distinguish the type of intervention and of the surgery.

The mechanical interventions to change the mechanics of the heart can take place in the heart or in the large blood vessels outside the heart.

The mechanical functioning of the heart can be changed by electrical add-ons inserting a pacemaker (PM) a PM and an implantable cardioverter defibrillator (ICD), biventricular pacing.

In the past, mechanical attempts to increase the contraction force through the so-called wrap heart, by which a prepared skeletal muscle was wrapped around the heart, required extensive preparation and operation and was ultimately not as effective as a therapy. For that reason and because of the fact that the procedure requires extraordinary skills of the surgeon, this procedure is seldom used. Moreover, it is a major burden for the patient.

Mechanical intervention can take place in the structure of the heart so that congenially defective structures are replaced by structures resembling the original structures as much as possible (eg Atrial septal defect (ASD) and Ventricular septal defect (VSD) or by removing obstructing structures (eg subaortale membrane, Asymmetrical septal hypertrphy (ASH), coronary artery stenoses) or by replacing defective dysfunctional structures by structures resembling the original structures as much as possible (eg Aortic valve replacement (AVR) Mtral valve replacement (MVR) Pulmonal valve replacement (PVR). In all these cases it is the aim to restore normal heart mechanics as much as possible by repairing, replacing or removing the defect.

By far most heart surgery in the world is carried out within this category of mechanical intervention.

Sometimes trying to restore the normal mechanics of the heart as close as possible is not the best way of intervention and an operation in the heart adding structures in the heart which support the failing heart but in which essentially normal blood flow and thus hemodynamics are changed can appear to be the best solution.

There are pumps that are relatively easily inserted, such as the Pulse-Cath or the ELS or the new "impella" intracardiac microaxial pump for treatment of right heart failure after orthotopic heart transplantation (J.Martin, Transplantation Proceedings, Volume 33, Issue 7, Pages 3549-3550) Further reading is provided in Puskas J, Cheng D, Knight J, et al. Off-pump versus conventional coronary artery bypass grafting: a meta-analysis and consensus statement from the 2004 IMICS consensus conference. Innovations 2005;1 :3-27. Dewey TM, Herbert MA, Prince SL, et al. Avoidance of cardiopulmonary bypass improves early survival in multivessel coronary artery bypass patients with poor ventricular function. Heart Surg Forum 2004;7:45-50. 3. Mihaylov D, Verkerke GJ, Blanksma PK, Elstrodt J, de Jong ED, Rakhorst G. Evaluation of the optimal driving mode during left ventricular assist with a pulsatile catheter pump in calves. Artif Organs 1999;23:1 1 17-22. 4. Mihaylov D, Rakhorst G, van der Plaats A, et al. In vivo and in vitro experience with the PUCA-II, a single valved pulsatile catheter pump, lnt J Artif Organs 2000;23:697-702.

Usually they are intended to support the heart during a high-risk percutaneous intervention (eg PVR, Main-stem dilation). There are also pumps that can only be implanted by a major operation eg the well known cardiac assist devices. Further reading theron is provided in McGee MG, Zillgitt SL, Trono R, Turner SA, Davis GL, Fuqua JM, Edelman SK, Norman JC. Retrospective analyses of the need for mechanical circulatory support (intrasortic balloon pump/abdominal left ventricular assist device or partial artificial heart) after cardiopulmonary bypass. A 44 month study of 14,168 patients. Am J Cardiol. 1980 Jul;46(1 ):135-142., Norman JC. Mechanical ventricular assistance: a review. Artif Organs. 1981 May;5(2):103-1 17. , Fuqua JM, Jr, lgo SR, Hibbs CW, Poirier VL, Chambers JA, Clay WC, McGee MG, Turner SA, Norman JC. Development and evaluation of electrically actuated abdominal left ventricular assist systems for long-term use. J Thorac Cardiovasc Surg. 1981 May;81 (5):718-726.Cooley DA, Liotta D, Hallman GL, Bloodwell RD, Leachman RD, Milam JD. Orthotopic cardiac prosthesis for two-staged cardiac replacement. Am J Cardiol. 1969 Nov;24(5):723-730.Cooley Denton A, Akutsu Tetsuzo, Norman John C, Serrato Miguel A, Frazier O Howard. Total artificial heart in two-staged cardiac transplantation. Cardiovasc Dis. 1981 Sep;8(3):305-319.

All these pumps operate on an external energy source and require a bedridden patient. Exceptionally such a device leaves the patient a limited mobility. Finally, the mechanical functioning of the heart may be supported by an intervention outside the heart itself in the large vessels for the purpose to let the heart pump against a smaller resistance. The structure of the heart itself remains essentially unchanged.

If Hemoglobin content is high enough, phlebotomizing (bloodvein) is the most simple form, reducing pre-and afterload by decrease in circulating volume but is still effective, even though the method is somewhat obsolete. The use of a balloon pump is widespread and is still undergoing improvements. The coronary perfusion begin diastole by inflation of the balloon is increased while end-diastolic afterload is reduced by deflation. The Intra Aortic Balloon Pump (IABP) reduces especially afterload, but is only temporarily applicable, not in a serious sclerotic aorta and also requires energy administration from the outside (P. J Overwalder: Intra Aortic Balloon Pump (IABP) Counterpulsation . The Internet Journal of Thoracic and Cardiovascular Surgery. 1999. Volume 2 Number 2).

The method wherein a valve is inserted in the aorta descendens shortly after branching of the left subclavian artery for the treatment of acute or chronic congestive heart failure is a unique solution for the problem to influence the defective mechanical functioning of the heart by an intervention outside the heart itself in the large vessels with the aim to relieve the heart by diminishing afterload.

In the run-up to replace the aortic valve with a mechanical valve the preservation of adequate coronary perfusion was estimated such an overwhelming problem that this prevented direct replacement Therefore as a first step insertion of a valve in the aorta as close as possible to the aortic valve but behind the arteries of the head and the arms was chosen to study the effects of valve replacement. In both cases this application was limited to pure aortic insufficiency. This was reasonable from the viewpoint to replace the defect in the heart by approaching normal function as close as possible, thought in reconstructing defective structures in the heart Precursors of the first surgically replaced aortic valve and the first percutaneously implanted aortic valve were valves both placed in the aorta descendens These were the valve inserted in 1953 by Hufnagel and the percutaneous inserted valve described in 2000 by Boudjemline and Bonhoeffer.

According to Hufnagel and Boudjemline and Bonhoeffer it is not possible to implant the artificial valve between the coronaries and truncus brachiocephalicus because this would quickly lead to ischemia by compromising coronary flow.

It is therefore that these experiments fall within the scope of Changes to the heart itself by replacing the mechanical defect to restore the original function as much as possible and not in the scope of Changes outside the heart, in the large vessels.

Hufnagel has implanted in patients with severe aortic insufficiency (Al) events a ball in a cage high in the aorta descendens, he estimated that 75% of the cardiac output flows through the valve. It is estimated that some 4000 Hufnagel valves were implanted but only 55 are described well in the literature (Hufnagel CA, Harvey WP: The surgical correction of aortic regurgitation, Preliminary report. Bull Georgetown Univ Med Center 6:60-61 , 1953 2 Hufnagel CA, Harvey WP, Rabil PJ, et al: Surgical correction of aortic insufficiency. Surgery 35:673-683, 1954 3 McKu. sick VA, Hahn DP, Brayshaw JR. et al: Some hemodynamic effects of the Hufnagel operation for aortic regurgitation. Studies in models and a patient. Bull Johns Hopkins Hosp 95:322-377, 1954 4 Conklin WS, Grismer JT, Aalpoel JA: Hufnagel valve surgery for aortic insufliciency. J Thorac Surg 36:238-246, 1958 5 du Plessis LA, Chesler E, Rogers M, et al: Aortic valve replacement in the presence of a Hufnagel valve prosthesis. J Thorac Cardiovasc Surg 51 :493-497, 1966 6 Halkier E, Hansen PF, Anderson I: Aortic incompetence: The eventual outcome in a small series treated with Hufnagel's descending aorta ball-valve. Scand J Thorac Cardiovasc Surg 4:52-55, 1970 7 Cohn LH, Roberts WC, Rockoff SD, et al: Bacterial endocarditis following aortic valve replacement. Clinical and pathologic correlations. Circulation 33:209-217, 1966 8 Roberts WC, Morrow AG: Renal heniosiderosis in patients with prosthetic aortic valves. Circulation 36:390- 398, 1966 9 Roberts WC, Lambird PA, Gott VL, et a!: Fatal aortic regurgitation following replacement of the uiitral and aortic valves. A mechanical complication of double valve replacenient. J Thorac Cardiovasc Surg 52:189-192, 1966 10 Roberts WC, Morrow AG: Bacterial endocarditis involving prosthetic mitral valves. Clinical and pathologic observations. Arch Pathol 82:164-169, 1966 )

The valve was in some cases 13 years in function (Cardiovascular Pathology, Volume 1 1 , Issue 6, Pages 351 -353). Hufnagel describes the effects of the valve in case of Al are decrease in afterload, an increase of cardiac output (up to 75%), decrease of the Pulmonary artery pressure (PAP), a decline in Cor-thorax ratio (CTR), a reduction in New York Heart Association (NYHA) class and increase exercise tolerance.

Boudjemline and Bonhoeffer have implanted a valve in the aorta descendens in lambs by percutaneous insertion after they made an Al artificially.

Earlier they had successfully implanted pulmonary valves this way. They argued that minimum back flow is necessary for any valve for sustained performance. Boudjemline and Bonhoeffer (Circulation. 2002;105:775.) 2002 American Heart Association, Inc.) describe an increase in cardiac output (CO) and coronary flow and decrease in peripheral pressures.

US2006074483 describes a method of treatment and devices for the treatment of left ventricular failure. US3671979 describes a catheter mounted artificial heart valve for implanting in close proximity to a defective natural heart valve. US4056854 describes an aortic heart valve catheter. These are all catheter based mechanical techniques for treating the decompensated heart in the acute setting with temporary support, as far as we know these are the only three examples. The primary purpose of these three patented devices in the acute setting was to develop a cheaper solution than the IABP, with less monitoring needed. The entire expandable and impandable valves with mounting catheter remains in situ. The patient is bedridden and the valve must be removed after a short time.

Both Hufnagel and Boudjemline and Bonhoeffer state that implantation of a artificial valve between the coronary ostia and truncus brachiocephalicus quickly leads to ischemia by compromising coronary flow. The current valves most used for PAVR are the Core Valve Revalving (18F) and the Edwards Sapien valve. In addition, stent-valves in development are the Bonhoefer valve, valve Aortech, Panagua valve, 3-F valve, Palmaz-Baily valve, Direct Flow valve, AorTx cover and Sadra Lotus valve.

The invention is primarily aimed at intraluminal and percutaneous insertion of an organic 3-Strut self-expandable or balloon mounted artificial valve, with only flow possible in the blood flow direction, which is inserted in the aorta descendens, preferably positioned a few cm after the left subclavian artery and is called artificial valve in the aorta descendens (AVAD). Preferably the valve can be delivered with a 24, 18 or less French catheter.

In a preferred embodiment, the AVAD is a biological valve because this presents no resistance to blood flowing in the aorta (gradient over the valve 0 mm

Hg). The primary function of the valve is in reducing afterload downstream of the valve, where estimated 75% of Cardiac Output flows through. The compliance of the vascular system after this valve makes that during diastole the pressures are conducted only to the periphery and that the reflected wave of the first and higher order from the periphery are at least partly, sometimes even completely stopped in diastole. This decrease in afterload has a positive effect so that the CO increases, the lower PAP will reduce the shortness of breath and the exercise tolerance increases.

Application of the Edwards Sapien valve is contra-indicated for a patient with pure Al. The valve of the invention (AVAD) will best the best solution nowadays available for treating pure Al in a patient that has an opreation indication for AVR but who has also too many contra-indications to perform this.

Moreover, it is anticipated that positive effects will be augmented by increase of contractility due to less segmental dyssynchronicity within the left Ventricle.

It is also anticipated that about half of the beneficial effects that can be obtained by an IABP may be obtained by insertion of the AVAD.

Bicuspid or tricuspid artificial valves are both suitable for placement in the device. It should be noted however that incomplete closure of the bicuspid valve especially in aging of the valve, as usually some degeneration is seen, occurs less often with a tricuspid valve. The pull forces will in the tricuspidal case be more spread over the whole annulus of artificial valve and will thus be smaller per square mm of the aortic wall and thus beneficial in preventing stent migration. The forces on the AVAD will only occur in retrograde direction during diastole, in the target population and is estimated to remain below 100 mm Hg, such as 75 or 50 mm Hg. The fixation by means of an expandable stent in the aortic wall must resist these forces, it is therefore preferred that the valve is placed at the upsteam end of the stent and that the stent is at least 5 cm long. The downstream side is in particular the fixation side.

In order to prevent overgrowth of the leaflets of the permanent valve, the leaflets may comprise a drug eluting coating or equivalent means. The meshes in the stent should be large enough to maintain an unrestricted blood flow to the branching arteries. This invention is part of mechanical support techniques for a decompensated heart and is the only one which may be applied in the chronic setting even if the valves of the heart itself are intact. Patients suffering from chronic congestive heart failure class NYHA III or IV may particularly benefit from the present invention. The described invention is a simple outpatient applicable mechanical form of intervention that may be used for chronic heart failure in the mobile patient. The inventor proposes the name VandenBerg Valve for a device according to the invertion in the case of a permanent applied valve and the name VandenBerg Balloon Valve in case of the temporary applied valve. The AVAD provides the advantage of allowing a reduced risk of the procedure due to the percutaneous transluminal placement. This provides a reduced invasiveness and reduced complexity of insertion. It is a prerequisite for this technique that the aorta descendens after the left subclavian artery is intact over about seven or more centimeters. A device according to the invention provides the advantage that the valve is able to sustain a backward pressure gradient of more than 100 mm Hg. Such is true even at an early stage, when the valve is still not covered with endothelium, without dislocation.

The device according to the invention may be placed in a smooth as well as a sclerotic aorta. If properly placed, i.e. at a few cm from the subclavian left artery and with a max length of 7 cm, the device will not provide any problems with prior arteries. In a device according to the invention, the chances of valve degeneration are minimal. and the chances of endothelial growth on the valve leaflets are also minimal. Moreover, there is no antegrade gradient over the device according to the invention. If the device according to the invention comprises Dacron, endothelialization is facilitated and any micro-embolies may be prevented but this is not mandatory. A device according to the invention may be applied or delivered to a patient using a conventional balloon. The inserted valve mounted on the balloon has a minimum diameter to be able to pass the femoral artery without much risk of damage. In an alternative embodiment of the invention, a temporary valve is provided. Such a device may comprise a low gradient valve mounted on a catheter mounted within a cylindrical thin balloon that functions as its stent. This is herein further referenced as a balloon valve. The catheter contains at least a lumen for inflation of the balloon and a lumen for guiding a conductance catheter for measurement in the Left Ventricle and Aorta. The catheter is directly connected to the wall of the cylinder and may have connections from proximal and distal ends of the cylinder to several places on the edges of the cylinder. These connections may be applied for stability and also to be able to deliver and to retrieve the balloon and valve as depicted in figures 3 and 4. Such a device may be delivered percutaneously and transluminal^ and is non thrombogenic. This device provides properties that anchor the balloon in the aorta descendens and prevent its derealization by the blood flow in the aorta. The gradient of the device as a whole in the aorta in systole is not significantly different from zero. If necessary cylindrical balloon of the device can be inflated slightly oversized for better fixation in the aorta and to prevent a diameter step in the transition aorta cylinder.

A temporary valve such as a balloon valve may be used for simulation of the permanent valve to investigate its applicability in selected patients but also for investigational purposes, to lower the afterload of the left ventricle i.e. the treatment of acute HF or for routine clinical use. It may be used to study the properties of the aorta such as stiffness, reflection waves, pulse wave velocity and elasticity. For this purpose the Balloon Valve can be inflated shortly at different places in the aorta. When the time interval for the measurement remains short at each level there will be no damage as a consequence of occluding side branches during inflation. These measurements may lead to somewhat adjusted recommended optimal placement sites in the aorta in selected cases of aorta stiffness.

The temporary valve can also be used to determine whether it makes sense to place a permanent device in order to treat the patient.

Preferably the invention can be delivered with a 18 or less French catheter. In a preferred embodiment, the invention is a biological valve because this presents no resistance to blood flowing in the aorta (gradient over the valve O mm Hg).

The primary function of the Balloon Valve, placed shortly after the left subclavian artery is in reducing afterload downstream of the valve, where estimated 75% of Cardiac Output flows through. The compliance of the vascular system after this valve makes that during diastole the pressures are conducted only to the periphery and that the reflected wave of the first and higher order from the periphery are completely stopped in diastole.

Moreover, it is anticipated that positive effects will be augmented by increase of contractility due to less segmental dyssynchrony within the left Ventricle. To prevent pressure usures to the aortic wall the cylinder length of the balloon is at least 7 cm long. The balloon valve can also be produced for selected cases to withstand inflation pressures up to 22 atmosphere in order to obtain enough stability of the valved-balloon, the valve itself and or fixation in the aorta.

This balloon valve is part of mechanical support techniques for a decompensated heart and is the only one which may be applied in the chronic setting even if the valves of the heart itself are intact.

The described balloon valve is a simple applicable mechanical form of intervention that may be widely used for acute heart failure in the bedridden intensive care patient. The balloon valve provides the advantage of allowing a reduced risk of the procedure due to the percutaneous transluminal placement. This provides a reduced invasiveness and reduced complexity of insertion. It is a prerequisite for this technique that the aorta descendens after the left subclavian artery is intact over about seven or more centimeters. A balloon valve provides the advantage that the valve is able to sustain a backward pressure gradient of more than 100 mm Hg. Such is true even at an early stage, when the valve is still not covered with endothelium, without dislocation.

The balloon valve may be placed in a smooth as well as a sclerotic aorta. If properly placed, i.e. at a few cm from the subclavian left artery and with a max length of 7 cm or, as is the case with aorta measurements, will be applied so shortly that the device will not provide any problems with prior arteries.

In a balloon valve, chances of valve degeneration are minimal and the chances of endothelial growth on the valve leaflets are also minimal. In other words, valve degeneration and the chances of endothelial growth on the valve leaflets are no issue within the short time the balloon valve resides

Moreover, there is no antegrade gradient over the device according to the valve. If the valve comprises Dacron, endothelialization is facilitated and any micro-embolies may be prevented.

A balloon Valve may be applied using a cylindrical balloon. The inserted valve and the balloon have a minimum diameter to be able to pass the femoral artery without much risk of damage.

Legends to the figures

Figure 1 : Pattern of the wall of a stent according to the invention Figure 2: Stent with valve placed in the aorta descendens Figure 3: Balloon valve. Reference signs indicate a thin cylindrical balloon 10, a hollow catheter 20, fixation wires 30 and a valve 40 comprising multiple leaflets .

Figure 4: cross section of the hollow cylindrical balloon 10 showing fixation wires 30, a tricuspid valve 40 and the hollow catheter 20 with a lumen 21 . The lumen 21 of the catheter may be used to allow a measurement device to pass through the catheter along the balloon into the aorta at the cardiac site of the valve. Catheter 20 may also be placed through the lumen of the balloon in the axial direction of the cylinder. The lumen 21 of the balloon may also contain means for inflating the balloon, such as an air guide connected to a pump outside the patient. In that case, the support wires 30 then form a pyramid structure and the air connection is a separate connection to the inner side of the balloon.

Claims

1 . A method for the treatment of a disease selected from the group consisting of acute and chronic congestive heart failure, coronary diseases, arterial diseases, heart valve diseases, cardiomyopathic diseases, decompensatio cordis and asthma cardiale wherein an artificial valve is placed in the aorta descendens after the left subclavian artery.

2. Method according to claim 1 wherein the valve is a tricuspid valve.

3. Method according to claims 1 or 2 wherein the artificial valve is part of a temporary device, more in particular a valve mounted on a balloon.

4. Method according to claims 1 or 2 wherein the artificial valve is part of a permanent device, such as a valve mounted on a stent.

5. A cylindrical balloon comprising a valve in its inner lumen suitable for placement in the aorta descendens mounted on a catheter.

6. Balloon according to claim 5 wherein the valve is a tricuspid valve.

7. A stent suitable for implantation in the aorta descendens comprising a valve and means for anchoring the stent in the aorta descendens.

8. Stent according to claim 7 wherein the valve is a tricuspid valve.

9. A stent according to claims 7 or 8 comprising a structure according to figure 1 .

10. A method for the simulation of a permanent treatment of a disease selected from the group consisting of acute and chronic congestive heart failure, coronary diseases, arterial diseases, heart valve diseases, cardiomyopathic diseases, decompensatio cordis and asthma cardiale wherein an artificial valve is temporarily placed in the aorta descendens after the left subclavian artery.

1 1 . Method according to claim 10 wherein the artificial valve is part of a temporary device, such as a balloon according to claim 5.