Article supplied by the Eucomed Joint Industry Group for Heart Failure Awareness. The aim of this group is to raise awareness on the value of medical technology for the treatment of heart failure.
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The theme of this year's World Heart Day is 'Team up for Healthy Hearts'. This is particularly appropriate when considering the impact medical technology has on improving the lives of patients with cardiac rhythm disease. The medical technology industry thrives on fruitful partnerships with the medical community and patients. From the development of new technological applications which respond to patients' needs, to those providing patient care, teamwork has always been the key.
World Heart Day 2007 precedes the 50th anniversary of implantable cardiac rhythm management devices by just a few months. The very first cardiac pacemaker was implanted at the Karolinska Institute in Stockholm in 1958. Following successful therapy, with the device maintaining a normal, steady heart rate, the patient, Arne Larrson, went on to live for 43 years, witnessing many major developments in this important area of medical technology.
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| The first pacemaker implanted included electrical components housed in epoxy resin and was attached to the heart by insulated stainless suture wires. The batteries had limited life and had to be recharged weekly. |
Pacemakers have since become the standard therapy for patients suffering from slow heart rhythms, also known as bradycardia. In 2006 nearly 1 person per 1000 was treated using a pacemaker in Western Europe and the US. Pacemakers provide a simple solution, radically restoring a patient's quality of life and increasing their life expectancy. By working together with the medical community many advances in pacemaker functions have been achieved, relieving patient symptoms caused by complex pathological heart rhythms. In addition, thanks to advances in components, materials and intellectual property, bradycardia sufferers today have access to devices that are smaller, longer lasting, more reliable and able to adapt to the heart in ways that could not have been imagined in 1958.
Pacemakers have been very successful in prolonging and improving the lives of many patients with slow heart rates since their inception. Implantable rhythm management devices, however, have risen to other challenges.
Following the death of Professor Harry Heller, (Chief of Medicine, Tel Hashomer Hospital) in 1966 from ventricular tachyarrhythmia (defined as an unusually fast heart rhythm) his assistant, Dr. Michel Mirowski, in conjunction with Dr. Morton Mower (Sinai Hospital of Baltimore), embarked on 12 years of research and development to design an implantable defibrillator, which could restore fast rhythms to normal with an electric shock. The team in Baltimore realised the impossible by developing the Implantable Cardioverter Defibrillator (ICD), culminating with the first patient receiving an ICD on 4 February 1980. However, early devices were large and uncomfortable, and testing procedures were cumbersome. This meant that they were reserved only for patients at very high risk of sudden cardiac death.
Sudden cardiac arrest (SCA) occurs when the electrical system to the heart malfunctions and suddenly becomes very irregular. The heart beats dangerously fast. The ventricles may flutter or quiver (ventricular fibrillation), and blood is not delivered to the body. In the first few minutes, the greatest concern is that blood flow to the brain will be reduced so drastically that a person will lose consciousness. Death follows unless emergency treatment is begun immediately.
Dr. Mirowski also foresaw that developing a treatment for SCA would have far reaching benefits for arrhythmia survivors and, indeed, many patients without known arrhythmias. Sudden cardiac death is today recognised as the most common killer in the US. It is estimated to account for more deaths than lung cancer, breast cancer and AIDS combined.[1]
The medical technology industry has worked continuously since 1980 to improve and make these devices accessible to a larger number of patients, resulting in lifesaving systems that can be implanted in very much the same way as a simple pacemaker. In addition, clinical evidence shows that in the future ICDs will not only prevent SCA, but could also be used to prevent death from ventricular arrhythmias in several high risk groups of patients with no history of heart rhythm problems.
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to a normal rate by the delivery of an electrical shock inside the heart. |
Ensuring high quality services can be achieved by the medical technology industry providing constant support in terms of education, training and technical advice to medical professionals in this complex area of medicine. As the numbers of patients with ICDs increase, so does the management burden for healthcare providers. Here, too, industry is helping by automating many of the device functions, and increasingly providing home monitoring technologies which allow much of the information required for analysing patient and device wellbeing to be passed regularly to the physician whilst the patient sleeps. Routine checks are also being optimised in terms of duration and the frequency of hospital visits.
Preventing death by the delivery of electrical shocks directly into the heart is certainly a dramatic contribution to cardiac medicine, but there are new therapies which are also having a dramatic effect on improving the lives and life expectancy of heart failure patients.
Heart failure is a general description of symptoms that develop as a result of heart function deterioration. This deterioration can be due to many causes, but ultimately the pumping efficiency of the heart degenerates over time with increasingly severe symptoms of breathlessness and fatigue, even during periods of inactivity. Heart failure is a problem for patients and healthcare providers alike. An estimated 10 million patients suffer from heart failure in Europe with their prognosis being very poor[2]. Half of all heart failure patients die within 4 years of diagnosis. Approximately half of patients with more severe symptoms die within a year. In addition, hospital treatment of heart failure in the US has the largest impact on medical resources than any other condition.
More information on heart failure and the wide range of treatments can be obtained from http://www.heartfailurematters.org
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The upper lead is being placed in a vein running outside the left ventricle. The tips of these leads will stimulate and resynchronise the heart. |
Major clinical studies have shown improvements mortality rates and in the quality of life related to cardiac resynchronisation therapy (CRT) for particular groups of heart failure patients.
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even for patients on optimal pharmaceutical therapy. |
Due to the continuing collaboration between industry, physicians and patients, CRT has been included in both the European Society of Cardiology and American Heart Association/American College of Cardiology Guidelines for the treatment of heart failure patients. This therapy is recognised as highly effective, a view which is backed by strong clinical evidence.
Further investigations are underway on the benefits of CRT for a wider group of patients suffering from heart failure. As with the ICD, home monitoring is being employed to minimize hospital visits and sensors are being introduced to pre-empt a worsening of symptoms. The future for CRT is very exciting with the main beneficiaries being patients who otherwise would have little hope of improvement in their condition.
1 in 10 patients eligible for CRT referred by their physician
It should be noted that less than 1 in 10 patients who could be eligible for CRT or an ICD are actually referred by their doctor[3]. One of the goals of the Eucomed Joint Industry Group for Heart Failure Awareness is to address this gap. In recent surveys, cost has been quoted as a major block for device implantation referrals and has often been cited by healthcare providers as a major concern. It is very clear, however, when analyzing the large study populations from a health economic perspective that even the most sophisticated CRT devices are more cost effective than other well-accepted therapies. CRT-D implants for heart failure patients have been shown to be more cost-effective per life year saved than some lipid lowering drugs, renal dialysis and even simple coronary angiography. Improved patient selection, shorter procedure times and more sophisticated functions and sensors will further increase cost-effectiveness in the future.
The goals of World Heart Day 2007 to team up for healthy hearts will remain the philosophy of those working in Cardiac Rhythm Management arena. So much has been achieved since the first simple pacemaker was designed 50 years ago. The understanding of the conditions addressed by our devices increases on a daily basis and by World Heart Day 2008 around ½ million new patients will be benefiting from the results of 50 years of innovation.
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| Patient numbers are rising with new indications being opened up by studies, but implant rates are lagging behind. Many patients are missing out on life saving and life enhancing therapy. |
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[1] American Heart Association Heart Disease and Stroke 2003 Update (Download as PDF)
[1] National Vital statistics Report - CDC, Volume 54, Number 19 June 28, 2006, Deaths: Preliminary Data for 2004
[2] ESC Guidelines - Guidelines on the Diagnosis and Treatment of Acute Heart Failure 2005 Update (Download as PDF)
[3] Mustafa Toma MD, The American Journal of Cardiology, Volume 97, Issue 6, 15 March 2006, Pages 882-885
