CARDIOLOGY

With open-heart surgery performed just after World War 2 and the first European heart transplant some 50 years ago in April 1968, France constantly proves its world-class ranking and skills in the cardio-thoracic field.

French doctors and surgeons use cutting-edge techniques and high end technology in :

- Interventional cardiology : coronary arteries treatment without surgery,

- Dilated cardiomyopathy : the world's first coronary stent was implanted in March 1986, by Pr. Puel in Toulouse and in April 1986, the first balloon aortic valvuloplasty by Pr. Alain Cribier in Rouen

- Structural cardiology with non-surgical treatment of heart valves : the world's first valve bio-prosthesis designed and implemented by Pr. Carpentier at the end of the 60s, the world's first TAVI (Transcatheter Aortic Valve Implantation) in April 2002 by Pr. Cribier in Rouen and the world's first mitral valve replacement under transcatheter endoscopy performed by the Lille Heart Institute Hospital in November 2018

- Electrophysiology : wireless pacemakers and defibrillators, ablation of cardiac arrhythmias

- Heart transplant: European leader since 1968 in terms of activity (over 500 heart transplants per year, around 10% of the world’s total), performing world premières with the first - and still unique - fully autonomous artificial heart, the French-built CARMAT, implanted in a human in 2013 by Pr. Carpentier in Paris.

Out of 3,065 hospitals and clinics in France, 1,172 deal with infarctus, 763 with hypertension, 536 with pacemarkers and electric intracardiac treatments, 399 with vein and artery treatments, 384 with carotid treatment, 56 performing heart surgery on adults, 16 on children and young adults.    

In these leading edge fields, C3Medical is proud to be a close partner, for adults, with IMM / Institut Mutualiste Montsouris Hospital in Paris, managing its international patient activity and, for children, with Necker Enfants Malades (Sick Children) Hospital in Paris. (See video in introduction of "Complex Pathologies" section and description in "C3Medical Hospital Network" by clicking on the logo in the lower banner).

 

APRIL 1968 - FIRST HEART TRANSPLANT IN EUROPE

Some 50 years ago, in April 1968, 4 months after Pr. Christiaan Barnard's world-première in Groote Shuur Hospital, the Cape-South Africa, Pr. Alain Cabrol performs in Paris, the first heart transplant in Europe.

FIRST FULLY AUTONOMOUS ARTIFICIAL HEART

CARMAT BIOPROSTHETIC HEART


On 27 October 2008, French professor and leading heart transplant specialist Alain F. Carpentier announced that a fully implantable artificial heart would be ready for clinical trial by 2011 and for alternative transplant in 2013. 

It was developed by him and would be manufactured by biomedical firm CARMAT SA, a joint venture between Pr. Carpentier, French Matra group and venture capital firm Truffle Capital. 

The prototype used embedded electronic sensors and was made from chemically treated animal tissues, called "biomaterials", or a "pseudo-skin" of biosynthetic, microporous materials. 

According to a press-release by Carmat dated 20 December 2013, the first implantation of its artificial heart in a 75-year-old patient was performed on 18 December 2013 by the Georges Pompidou European Hospital team in Paris (France). The patient died 75 days after the operation. 

In Carmat's design, two chambers are each divided by a membrane that holds hydraulic fluid on one side. A motorized pump moves hydraulic fluid in and out of the chambers, and that fluid causes the membrane to move; blood flows through the other side of each membrane. The blood-facing side of the membrane is made of tissue obtained from a sac that surrounds a cow's heart, to make the device more biocompatible. 

The Carmat device also uses valves made from cow heart tissue and has sensors to detect increased pressure within the device. Information is sent to an internal control system that can adjust the flow rate in response to increased demand, such as when a patient is exercising. This distinguishes it from previous designs that maintain a constant flow rate.

The Carmat device, unlike previous designs, is meant to be used in cases of terminal heart failure, instead of being used as a bridge device while the patient awaits a transplant. At 900 grams it weighs nearly three times the typical heart and is intended primarily for obese men. It also requires the patient to carry around an additional Li-Ion battery. The projected lifetime of the artificial heart is around 5 years (230 million beats). 

In 2016, trials for the Carmat "fully artificial heart" were banned by the National Agency for Security and Medicine in Europe after short survival rates were confirmed. The ban was lifted in May 2017. At that time, a European report stated that Celyad’s C-Cure cell therapy for ischemic heart failure "could only help a subpopulation of Phase III study participants, and Carmat will hope that its artificial heart will be able to treat a higher proportion of heart failure patients".

A January 2019 update in Europe stated that the only fully artificial heart currently on the market was the SynCardia device and that the Carmat’s artificial heart ("designed to self-regulate, changing the blood flow based on the patient’s physical activity") was still in the early stage of trials.

That report also indicated that Carmat was, in fact, still hoping to "gain market approval for its implant this year but is now aiming to achieve this next year. One reason for this is that the complex technology has been undergoing refinements in the manufacturing process".

Source: Wikipedia (19 05 2019)

 

CARMAT ARTIFICIAL HEART: ELEVENTH PATIENT IMPLANTED

A male patient has just undergone successful heart transplant surgery five months after receiving a Carmat artificial heart. Surgery was performed at the National Research Center of Cardiac Surgery in Astana, Kazakhstan. 

This is the second patient to undergo this type of procedure. The first Astana patient received a Carmat artificial heart in October 2017 and had not been eligible for heart transplant surgery because of his high blood pressure. 

In the eight months since receiving the artificial heart, the transplant patient's condition stabilised and transplant surgery could eventually be performed. "This world first shows that the Carmat artificial heart is also suitable for patients presenting co-morbidities which prevent transplantation in the first instance," explains Stéphane Piat, CEO of Carmat, even though "its primary purpose is to offer a permanent therapeutic alternative given the lack of transplant organs".
 
The French company is currently carrying out a European pivotal study to "get the green light to sell the product in Europe (CE marking) in 2019". Among the first 11 patients to receive a Carmat heart, the one month survival rate is 91%: one patient died after a few weeks from an infection which, according to the company, was not linked to the prosthesis. "We have switched to the second part of the study with the eleventh patient who has just undergone transplant surgery", explains Stéphane Piat. "My aim is to complete the study by the end of the year, as planned. However, to maximise our chances of success, caution must still be exercised in selecting the last nine patients". The six-month survival of twenty patients will be crucial for European certification.
 
Two other countries are currently involved in the clinical study, namely the Czech Republic with IKEM, in Prague and Denmark with Rigshospitalet, in Copenhagen. "We are in very advanced discussions with the FDA and hope to be granted authorisation to start a feasibility study in the US between now and the end of this year," adds the CEO.

Source: Les Echos & AFP, Chantal Houzelle (28/09/2018)
 

FIRST NON-INVASIVE MITRAL VALVE REPLACEMENT

The 1st mitral valve replacement surgery without opening the thorax or heart was performed at the Heart & Lung Institute, CHU-University Hospital of Lille, by Professor Eric Van Belle and Dr. Thomas Modine.

The medical and surgical team of the Lung Heart Institute of the CHU Lille led by Professor Eric Van Belle and Dr. Thomas Modine has performed the replacement of a mitral valve heart without opening the chest or heart. This minimally invasive procedure, carried out in November 2018, allowed a very rapid recovery of the operated patient.

It is indeed by going through the natural routes from a simple puncture in a vein of the patient's leg, that this valve has been implanted through a catheter, without the need to stop the heart.

The surgery was designed to correct a severe malfunction of the mitral valve, which is essential for heart function, in a patient who presented with a surgical risk that was too high for conventional open chest surgery. 

This medical prowess was made possible by the use of a new generation of mitral valve specially designed for this purpose (Cephea valve). It was realized with the participation of Dr. Godart, in pediatric cardiology, Dr. Brandt anesthesiologist and Dr. Pontana and Dr. Coisne for imaging, Lille University Hospital.

Real hope for patients with mitral insufficiency

Mitral insufficiency (or leakage) is the most common heart valve disease. It is responsible for heart failure, ie shortness of breath at the least very debilitating effort, and the appearance of edema in the legs.

Mitral insufficiency may appear with age or be the sequela of anterior heart disease such as myocardial infarction. Until now, the only surgical treatment available was to open the thorax to repair the valve or replace it with a prosthesis. This innovative intervention, practiced at the University Hospital of Lille, represents a real hope for people suffering from a mitral valve insufficiency for which none of the treatments currently available is effective and is too high risk to undergo conventional surgery.

In the future, it could benefit many patients. Lille masters the techniques of minimally invasive intervention. Its teams perform 300 aortic valve replacements per year by TAVI and this is the first time this implantation technique has been adopted for the replacement of a mitral valve. 

Source: website of the CHU-University Hospital, Lille - 1st Feb. 2019 – “A la une, 1ères mondiales, Innovation, Cardiologie - Pneumologie, Chirurgie - Chirurgie ambulatoire, Newsletter 976”

APRIL 1968 - FIRST HEART TRANSPLANT IN EUROPE

Some 50 years ago, in April 1968, 4 months after Pr. Christiaan Barnard's world-première in Groote Shuur Hospital, the Cape-South Africa, Pr. Alain Cabrol performs in Paris, the first heart transplant in Europe.

FIRST FULLY AUTONOMOUS ARTIFICIAL HEART

CARMAT BIOPROSTHETIC HEART


On 27 October 2008, French professor and leading heart transplant specialist Alain F. Carpentier announced that a fully implantable artificial heart would be ready for clinical trial by 2011 and for alternative transplant in 2013. 

It was developed by him and would be manufactured by biomedical firm CARMAT SA, a joint venture between Pr. Carpentier, French Matra group and venture capital firm Truffle Capital. 

The prototype used embedded electronic sensors and was made from chemically treated animal tissues, called "biomaterials", or a "pseudo-skin" of biosynthetic, microporous materials. 

According to a press-release by Carmat dated 20 December 2013, the first implantation of its artificial heart in a 75-year-old patient was performed on 18 December 2013 by the Georges Pompidou European Hospital team in Paris (France). The patient died 75 days after the operation. 

In Carmat's design, two chambers are each divided by a membrane that holds hydraulic fluid on one side. A motorized pump moves hydraulic fluid in and out of the chambers, and that fluid causes the membrane to move; blood flows through the other side of each membrane. The blood-facing side of the membrane is made of tissue obtained from a sac that surrounds a cow's heart, to make the device more biocompatible. 

The Carmat device also uses valves made from cow heart tissue and has sensors to detect increased pressure within the device. Information is sent to an internal control system that can adjust the flow rate in response to increased demand, such as when a patient is exercising. This distinguishes it from previous designs that maintain a constant flow rate.

The Carmat device, unlike previous designs, is meant to be used in cases of terminal heart failure, instead of being used as a bridge device while the patient awaits a transplant. At 900 grams it weighs nearly three times the typical heart and is intended primarily for obese men. It also requires the patient to carry around an additional Li-Ion battery. The projected lifetime of the artificial heart is around 5 years (230 million beats). 

In 2016, trials for the Carmat "fully artificial heart" were banned by the National Agency for Security and Medicine in Europe after short survival rates were confirmed. The ban was lifted in May 2017. At that time, a European report stated that Celyad’s C-Cure cell therapy for ischemic heart failure "could only help a subpopulation of Phase III study participants, and Carmat will hope that its artificial heart will be able to treat a higher proportion of heart failure patients".

A January 2019 update in Europe stated that the only fully artificial heart currently on the market was the SynCardia device and that the Carmat’s artificial heart ("designed to self-regulate, changing the blood flow based on the patient’s physical activity") was still in the early stage of trials.

That report also indicated that Carmat was, in fact, still hoping to "gain market approval for its implant this year but is now aiming to achieve this next year. One reason for this is that the complex technology has been undergoing refinements in the manufacturing process".

Source: Wikipedia (19 05 2019)

 

CARMAT ARTIFICIAL HEART: ELEVENTH PATIENT IMPLANTED

A male patient has just undergone successful heart transplant surgery five months after receiving a Carmat artificial heart. Surgery was performed at the National Research Center of Cardiac Surgery in Astana, Kazakhstan. 

This is the second patient to undergo this type of procedure. The first Astana patient received a Carmat artificial heart in October 2017 and had not been eligible for heart transplant surgery because of his high blood pressure. 

In the eight months since receiving the artificial heart, the transplant patient's condition stabilised and transplant surgery could eventually be performed. "This world first shows that the Carmat artificial heart is also suitable for patients presenting co-morbidities which prevent transplantation in the first instance," explains Stéphane Piat, CEO of Carmat, even though "its primary purpose is to offer a permanent therapeutic alternative given the lack of transplant organs".
 
The French company is currently carrying out a European pivotal study to "get the green light to sell the product in Europe (CE marking) in 2019". Among the first 11 patients to receive a Carmat heart, the one month survival rate is 91%: one patient died after a few weeks from an infection which, according to the company, was not linked to the prosthesis. "We have switched to the second part of the study with the eleventh patient who has just undergone transplant surgery", explains Stéphane Piat. "My aim is to complete the study by the end of the year, as planned. However, to maximise our chances of success, caution must still be exercised in selecting the last nine patients". The six-month survival of twenty patients will be crucial for European certification.
 
Two other countries are currently involved in the clinical study, namely the Czech Republic with IKEM, in Prague and Denmark with Rigshospitalet, in Copenhagen. "We are in very advanced discussions with the FDA and hope to be granted authorisation to start a feasibility study in the US between now and the end of this year," adds the CEO.

Source: Les Echos & AFP, Chantal Houzelle (28/09/2018)
 

FIRST NON-INVASIVE MITRAL VALVE REPLACEMENT

The 1st mitral valve replacement surgery without opening the thorax or heart was performed at the Heart & Lung Institute, CHU-University Hospital of Lille, by Professor Eric Van Belle and Dr. Thomas Modine.

The medical and surgical team of the Lung Heart Institute of the CHU Lille led by Professor Eric Van Belle and Dr. Thomas Modine has performed the replacement of a mitral valve heart without opening the chest or heart. This minimally invasive procedure, carried out in November 2018, allowed a very rapid recovery of the operated patient.

It is indeed by going through the natural routes from a simple puncture in a vein of the patient's leg, that this valve has been implanted through a catheter, without the need to stop the heart.

The surgery was designed to correct a severe malfunction of the mitral valve, which is essential for heart function, in a patient who presented with a surgical risk that was too high for conventional open chest surgery. 

This medical prowess was made possible by the use of a new generation of mitral valve specially designed for this purpose (Cephea valve). It was realized with the participation of Dr. Godart, in pediatric cardiology, Dr. Brandt anesthesiologist and Dr. Pontana and Dr. Coisne for imaging, Lille University Hospital.

Real hope for patients with mitral insufficiency

Mitral insufficiency (or leakage) is the most common heart valve disease. It is responsible for heart failure, ie shortness of breath at the least very debilitating effort, and the appearance of edema in the legs.

Mitral insufficiency may appear with age or be the sequela of anterior heart disease such as myocardial infarction. Until now, the only surgical treatment available was to open the thorax to repair the valve or replace it with a prosthesis. This innovative intervention, practiced at the University Hospital of Lille, represents a real hope for people suffering from a mitral valve insufficiency for which none of the treatments currently available is effective and is too high risk to undergo conventional surgery.

In the future, it could benefit many patients. Lille masters the techniques of minimally invasive intervention. Its teams perform 300 aortic valve replacements per year by TAVI and this is the first time this implantation technique has been adopted for the replacement of a mitral valve. 

Source: website of the CHU-University Hospital, Lille - 1st Feb. 2019 – “A la une, 1ères mondiales, Innovation, Cardiologie - Pneumologie, Chirurgie - Chirurgie ambulatoire, Newsletter 976”