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Valve for Life News - TAVI in Poland

The long-awaited agreement between cardiology and cardiac surgery regarding TAVI in Poland achieved.

An Expert Consensus of the Association of Cardiovascular Interventions of the Polish Cardiac Society and the Polish Society of Cardio-Thoracic Surgeons, approved by the Board of the Polish Cardiac Society and National Consultants in Cardiology and Cardiac Surgery was recently reached as a result of the Valve is Life campaign and the broad exchange of opinions of cardiologists and cardiac surgeons.

VFL country champions from Poland, France and Portugal share their vision on the given consensus as well as on the relevant situation in their countries.



Interview with the Valve for Life Poland Coordinators

Coordinators: Prof. Dariusz Dudek and Prof. Adam Witkowski

How was this agreement between Polish cardiologists and cardiac surgeons achieved and how was the joint position elaborated?

Almost one year was needed to develop a joint position of the Expert Group of the Association of Cardiovascular Interventions of the Polish Cardiac Society (PCS) and the Polish Society of Cardiothoracic Surgeons on the implementation of TAVI. After almost twelve months of work, it was possible to reconcile the positions of both groups, presenting the document "Transcatheter aortic valve implantation. Expert Consensus of the Association of Cardiovascular Interventions of the Polish Cardiac Society and the Polish Society of Cardio-Thoracic Surgeons, approved by the Board of the Polish Cardiac Society and National Consultants in Cardiology and Cardiac Surgery”

Who was involved in achieving the consensus?

The taskforce is composed mainly of the most experienced practitioners and representatives of Polish centers where most of the procedures are performed - Bialystok, Gdansk, Katowice, Krakow, Poznan, Rzeszow, Szczecin, Warsaw, Wroclaw and Zabrze - who are also a part of the TAVI TEAMs.

What will bring this agreement?

An interdisciplinary approach to the TAVI will standardize the procedures in all centres and create comprehensive guidelines for patient qualification, safe and effective treatment, and the acquisition of adequate financial resources.

The achieved consensus is a great success for both involved professional communities. It is no secret that in Poland as well as in the other countries, the implementation of TAVI has caused noticeable discussions on competences between cardiologists and cardiac surgeons. Thanks to this agreement, the two groups strongly confirmed the need for joint TAVI teams of certified specialists in interventional cardiology, cardiac surgery, anesthesiology, echocardiography, and nurses.

 

Prof. Dariusz Dudek_2017.jpg"Interdisciplinary cooperation is important for several reasons. First of all, in the qualification process, patient proposed by both cardiologists and cardiac surgeons are involved. In addition, patients are often elderly people, usually over the age of 75, who have multiple co morbidities - not just aortic stenosis. Consequently, the opinions of other specialists, including an anesthesiologist, neurologist, and sometimes an oncologist are also needed. In order to choose the best option, we have to include different persons in the decision-making process” especially for patients with many co morbidities."

Prof. Dariusz Dudek, M.D., Ph.D. - coordinator of the campaign "Valve for Life”.

How would the consensus influence the organisation and conduct of transcatheter treatment of patients with aortic valve disease in Poland?

The document prepared by Polish specialists was completed ahead of the simultaneously developed European guidelines. According to this document, intermediate-, high- or very high-risk patients may be eligible for TAVI. Patients will then go through an interview and a physical examination, which will be followed by a joint consultation between a cardiologist and a cardiac surgeon, and next a series of follow-up tests: esophageal echocardiography, computed tomography, and assessment of carotid and coronary arteries. The results consulted by the Heart Team will provide a basis for choosing TAVI or classic cardiac surgery. The risk of complications in TAVI is low and oscillates within a few percent. However, cases of vascular complications and bleeding, heart block, stroke (1-3%) and myocardial infarction (less than 1%) have been reported. There is also a group of patients who, due to their health status, cannot be eligible even for TAVI, and only conservative treatment or balloon valvuloplasty is possible.

What are the benefits of TAVI?

The benefits of TAVI are significant, especially for patients at high surgical risk, including older people, whose life reserves are low. TAVI is much less invasive, the sternum is not cut, it also does not require extracorporeal circulation, and the patient is often not even connected to a lung machine. When TAVI is performed by femoral artery puncture, only local anesthesia supported by light sedation is applied. Due to the fact that TAVI is minimally invasive, patients leave hospital three-four days after the treatment, while hospitalisation after cardiac surgery lasts for two weeks or even more.

Will this consensus between cardiologists and cardiac surgeons have an impact on the innovation?

The agreement between the Polish Cardiac Society and the Polish Society of Cardiothoracic Surgeons can also provide an opportunity to open Polish institutions for innovative solutions. One of them is the transcatheter Valve in Valve procedure dedicated to patients with surgically implanted aortic or mitral bioprosthesis, that has, after years of use, degenerated and caused the recurrence of narrowing and/or severe regurgitation. However, a specialist may implant a new transcatheter valve in its damaged counterpart so that the patient avoids another operation.
The latest methods can also help to save lives and the health of the youngest. We also do a research in Poland on a new transcahtheter aortic bioprosthesis.

 

Prof. Adam Witkowski.jpgA good example of innovation is a biodegradable polymer valve, which over time is inhabited by the patient's natural cells. The leaflets of this valve are no different from that of the natural aortic valve, and its polymer scaffolding degrades with time. This very interesting concept allows us to assume that the function of the biodegradable valve is identical to the natural valve, and after its transcatheter implantation in children it will continue to grow with them. If safety and efficacy of this concept is confirmed in clinical trials it would be a major breakthrough in transcatheter valve technology - adds Prof. Adam Witkowski, M.D., Ph.D., the campaign coordinator of "Valve for Life”.

What is the situation in regards to TAVI procedures in Poland versus the other countries of Europe?

Although the difference in the number of TAVI procedures per year between Poland versus other European countries is noticeable, a clear upward trend is evident. In the years 2014-2016, there was an increase of almost 100 % and another increase in the number of these treatments is forecasted for 2017. In Europe there is an average of 60 treatments carried out per 1 million inhabitants, while Germany is the record holder, where the number is 160 per 1 million. In Poland, the number of TAVI in 2014 was only 12 per 1 million and gradually increased to 22.5 per 1 million in 2016, also due to social media campaign Valve for Life, an EAPCI initiative. Specialists indicate that the current demand in Poland is at least twice as high, and our target is 2000 TAVI a year, which means approximately 50 TAVI per 1 million. It is also possible that in the next few years, the group eligible for TAVI will grow. There are currently ongoing randomised trials for TAVI in patients with severe symptomatic aortic stenosis and low surgical risk. According to our experts, the results will be announced no sooner than in two years and if positive, increase clinical needs for higher number of TAVI.

Interview with the Valve for Life France Coordinator

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Country coordinator: Prof. Martine Gilard

What is the relationship in your country between cardiologists and surgeons in relation to the treatment of transcatheter treatment of patients with aortic valve disease?

Since 2010, we have a good collaboration between surgeons and cardiologists in relation to the treatment of patients with aortic valve disease. Cardiac surgeons are involved in the decision meetings in every respective French center. Also, they are usually attending the procedures providing their active input. Moreover, their presence is mandatory for the reimbursement of the valve : in France, we cannot perform TAVI in the centers without cardiac surgery on site.

Has the relationship evolved since the start of the Valve for Life initiative?

No. There has not been any chance since the relationship was previously good.

Are you aware about it and what do you think about the Consensus Statement between the Association of Cardiovascular Interventions of the Polish Cardiac Society (ACVI) and the Polish Society of Cardio-Thoracic Surgeons?

We think it is a great achievement and we congratulate our Polish counterparts for reaching this consensus.

Would that be possible to reach similar consensus in France/ Portugal? Can the “multi-disciplinary TAVI team” become reality in your country sometimes soon?

It has already become a reality as we already have multi-disciplinary TAVI teams in French centres.

What are the hurdles that can prevent it from happening?

The hurdles are as mentioned above.

What are the differences between Poland and your country?

TAVI have been invented in France, and we performed a registry (FRANCE 2) on behalf of the French authorities. As the results were good, we obtained the necessary reimbursement and have it since 2012. Following this, the number of TAVI increased from 2,000 in 2011 to 9,000 in 2016. France faced another problem which was a low number of TAVI reimbursed. The French authority has set the respective number of TAVI at around 8,000. With the VFL initiative, we conducted the RAC registry that analysed the TAVI data of 1,100 patients from 45 implanting centres. Successful completion of the registry and presentation of its results has resulted in increase of the number of refunded valves from 7,500 to 20,000.

Interview with the Valve for Life Portugal Coordinators

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Country coordinators: Prof. Lino Patricio and Prof. Rui Campante Teles

What is the relationship in your country between cardiologists and surgeons in relation to the treatment of transcatheter treatment of patients with aortic valve disease?

Since the first official TAVI national meeting in January 2012, under the auspice of the Válvulas Percutâneas Working Groug of the Associação Portuguesa de Intervenção Cardiovascular (VaP APIC), there is a close collaboration ongoing between the main actors in this area, including all the Cardiac Surgery Directors and the surgical operators that have embraced the transcatheter techniques beyond transpical route.

Has the relationship evolved since the start of the Valve for Life initiative?

Surgeons are currently involved in several actions of the Valve for Life initiative and in 2017 they were invited to collaborate in our task force. The goal is to provide patients and relatives with a coherent message that shares their vision about the contemporaneous therapeutic possibilities of valvular diseases together with the interventional cardiology specialist. For instance, a few weeks ago one of our colleagues – a surgeon - was present at a respective TV program for aortic stenosis.

Are you aware about it and what do you think about the Consensus Statement between the Association of Cardiovascular Interventions of the Polish Cardiac Society (ACVI) and the Polish Society of Cardio-Thoracic Surgeons?

We congratulate the Polish colleagues for their excellent work and being a good example. After meeting the Portuguese Health authorities in April 2017, we started working on a strategic development plan that was shared with all Cath labs and Surgical Directors in October this year. The aim is to provide decision makers with our vision about future requirements for personnel, education, equipment and hardware necessities within the next 3 years.

Would that be possible to reach similar consensus in France/ Portugal? Can the “multi-disciplinary TAVI team” become reality in your country sometimes soon?

It is already a reality among all the Portuguese centres, as it is requested by the national official boundaries for TAVI emanated by Direção Geral de Saúde (DGS).

What are the hurdles that can prevent it from happening?

There are different institutional heart team approaches that have to reach a consensus to accommodate the volume changes in both conventional and transcatheter therapies.

What are the differences between Poland and your country?

The main characteristic is that only 5 out of 7 public Cardiac Surgery Centers have engaged in TAVI in 2017. Besides, the high differentiation of the senior surgeons is sometimes an obstacle to their own ability to spend time in transcatheter techniques and, therefore, the challenge is to allow them to let the young colleagues fully engage in the percutaneous world.