New Medical Technologies to Diagnose and Defeat America's Number One Killer
Courtesy of AdvaMed
One million American's die each year from cardiovascular disease - about 2,600 every day. Almost 60 million Americans suffer from the disease. Cardiovascular disease is the largest cause of hospitalization in the U.S., accounting for some $26 billion in Medicare expenditures alone.
Advances in medical technology are revolutionizing treatment of heart disease. Today doctors can detect it earlier and treat it more effectively and less expensively with an array of new minimally invasive and outpatient procedures. Many of these exciting innovations are on display at the April 30th event, Saving & Improving Lives of Those with Cardiovascular Disease and Stroke.
Diagnosing Heart Disease
Portable Ultrasound System
A physician's primary tool for assessing cardiac status, the stethoscope, was invented nearly 200 years ago. While the stethoscope provides much valuable information, certain things, such as chamber size and pumping function, are hard to hear, but easy to see. Cardiac ultrasound, or echocardiography, provides this important information, but these systems traditionally have been too expensive and cumbersome to be used as a routine part of the physical exam.
The Philips Optigo Cardiac Assessment Solution represents a new use for ultrasound, allowing physicians to obtain heart images in any care setting. OptiGo, which is about the size of a laptop computer, allows physicians to use ultrasound as part of a routine cardiac exam -- much as they use a stethoscope. But unlike a stethoscope, OptiGo gives the physician the capability to evaluate left ventricular function, valve function, chamber size and pericardial effusion. Lightweight and durable, OptiGo is ideal for settings such as a doctor's office, the CCU and ICU, emergency rooms, and outreach clinics, as well as for use during hospital rounds.
The heart can now be imaged in a variety of environments during the physician-patient encounter. This could facilitate earlier diagnosis and initiation of appropriate treatment, allowing physicians to order tests more selectively. A recent study from the University of Chicago found point-of-care ultrasound could significantly improve a cardiologist's ability to make an accurate diagnosis. According to Dr. Roberto Lang of the University of Chicago, "The use of the small device enabled physicians to double the number of accurate diagnoses compared to those made using a stethoscope."
Left Ventricular Assist Device (LVAD)
Ventricular assist devices like Thoratec's fully implantable HeartMate® Left Ventricular Assist System (LVAS) provides a lifesaving alternative for end-stage heart failure patients who have few medical alternatives beyond conventional drug therapies. HeartMate is implanted alongside a patient's native heart and is designed to take over the pumping ability of the weakened heart's left ventricle. The HeartMate brand has a record of more than 3,200 patients in 22 countries.
The HeartMate LVAS is designed to assist the heart's left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. The central component of the HeartMate LVAS, the implantable blood pump, is placed just below the diaphragm in the abdomen. Blood is channeled into the assist device and once blood from the natural heart empties into the pump, an external control system triggers pumping. The blood then flows through an outflow conduit and graft attached to the aorta, the main artery supplying the body with blood. The pump is attached between the natural heart and the aorta, leaving the natural circulation in place while providing all of the energy necessary to propel blood throughout the body. The HeartMate LVAS allows patients to be discharged from the hospital with a fully portable, wearable system and return to a near-normal lifestyle while on the device. Patients can resume work, school and other activities they were unable to do before receiving the device.
As a leading cause of hospital admissions for people over 65 in the U.S., congestive heart failure (CHF) can leave a health plan or hospital as consumed financially as the millions afflicted are physically and emotionally.
Philips Interactive Healthcare Services provides home monitoring technology services that can help reduce this costly cycle through a system of measurement and communication between patients at home and their health plan's care managers and physicians.
Patients use Philips wireless in-home measurement devices, which operate with a single button push or automatically. These devices may include a scale, a blood pressure unit that also measures pulse and a heart rhythm strip recorder, which measures ECG. The results are automatically and securely collected by a Philips home hub, located near the telephone, which transmits the objective data, using an ordinary phone line, to a server located at the care provider's office.
Patients whose daily measurements fall outside preset limits can be flagged for immediate follow-up, helping promote faster interventions. The care provider can easily access contact information for that patient and call them on the phone to find out why their measurements fell outside pre-set limits and work with them to get back on track.
In conjunction with a heart failure management program, Philips Interactive Healthcare Services (IHS) contributes to a provider's ability to lower costs by reducing the need for hospital readmissions and emergency room visits; improve care by providing accurate, timely and consistent data that helps care managers intervene earlier and make faster, better informed care decisions; and contribute to improved quality of life for people with CHF by helping to increase their compliance with lifestyle changes, i.e. diet, exercise and medication plan.
Coronary Artery Disease
Since the early to mid-1990s, bare (uncoated) stents have been used in conjunction with balloon angioplasty as a standard treatment in approximately 80% of interventional procedures for coronary artery disease. Use of bare stents has been shown to reduce post-procedure renarrowing of the blood vessel by 33 - 50% versus balloon angioplasty alone.
This treatment has been a major advance in the treatment of coronary artery disease, reducing the need to perform open-heart bypass procedures in many cases. However, even with the use of bare metal stents, the incidence of renarrowing has not been eliminated. Currently, an estimated 15 - 30% of stent patients develop restenosis (renarrowing) following their interventional procedure. This has a large impact on our Medicare system since a large number of these procedures are performed on elderly patients.
In an effort to reduce or eliminate restenosis, research has begun to focus on the potential of drugs delivered with stents as a method to address this issue. So-called "drug-eluting" stents have been implanted in more than 1,000 patients through clinical trials of this technology. The study results have been remarkable, showing that drug-eluting stents can virtually eliminate renarrowing of the artery and the subsequent need for repeat procedures to reopen the artery.
In the U.S. it is estimated that between 0.5 and 5% of people will develop an intracranial aneurysm and every year between 12,000 and 28,000 people suffer from ruptured intracranial aneurysms.
Aneurysms are caused by irregular blood flow patterns in the vessels in the brain. Over time the vessel walls can weaken and develop abnormal bulging/ballooning called aneurysms. The aneurysm may become vulnerable to rupture known as subarachnoid hemorrhage. When this occurs, blood flows into the brain or the space surrounding the brain and can cause serious damage and illness. An aneurysmal subarachnoid hemorrhage is a medical emergency. Ten to 15 percent of these patients will die before reaching the hospital. More than half will die within the first 30 days after the hemorrhage and of those survivors, about half will have some permanent deficit1. Patients diagnosed with unruptured aneurysms are often treated to prevent an initial hemorrhage and ruptured aneurysms are treated to prevent re-rupture and further damage to the brain.
The traditional method for treating an aneurysm involves a surgical procedure known as a craniotomy. A neurosurgeon removes a section of the skullcap, locates the aneurysm and uses small surgical clips to close off the aneurysm from the main vessel. The surgical procedure is highly invasive and involves a significant risk of patient morbidity and a long recovery time.
The GDC® coil offers a minimally invasive alternative for treatment of intracranial aneurysms. Aneurysm embolization involves accessing the diseased vessel in the brain using microcatheters. The physician inserts the catheter through the femoral artery in the patient's groin and navigates it through the vascular system, into the head, and into the aneurysm. The GDC platinum coils are maneuvered through the catheter and deployed into the aneurysm, obstructing blood flow into the aneurysm. Essentially, the aneurysm becomes excluded from the circulation, which reduces its risk of rupture or rebleeding.
More than 85,000 patients have been treated with GDC coils worldwide. Its minimally invasive approach is associated with fewer deaths, a lower rate of morbidity, a shorter length of stay in the hospital, and shorter recovery as compared to traditional craniotomy and aneurysm clipping. A study of more than 2,500 unruptured aneurysms at 60 large university hospitals found that surgical clipping had five times the rate of in-hospital deaths (2.3% vs. 0.4%) and an 80% greater rate of adverse events (18.5% vs. 10.6%) than endovascular coiling. Coiling cases also had a shorter length of stay (4.6 days vs. 9.6 days) and generated lower charges ($30,000 vs. $43,000)2.
Comparisons between surgery and endovascular treatment have not examined long term rupture and rebleed rates, and long term patency for endovascular treatment is under study.
1Malisch and Duckwiler, What you should know about aneurysms: A patient's guide to endovascular therapy.
2Johnston, SC, Surgical and endovascular treatment of unruptured cerebral aneurysms at university hospitals. Neurology 1999; 52: 1799-1805
Heart Rhythm Disorders
Innovative surgical ablation systems like Edwards Lifesciences' Optimaze hold promise as a new treatment for heart rhythm disorders that can significantly reduce the surgical time. Arrhythmia is abnormally slow (bradycardia) or fast (tachycardia) heart rate and is associated with various disorders of the cardiac conduction system.
An arrhythmia occurs:
When the heart's natural pacemaker develops and abnormal rate or rhythm
When the normal conduction pathway is interrupted
When another part of the heart takes over as pacemaker
Arrhythmia accounts for up to 20% of all diseases treated by cardiologists.
Arrhythmia is the cause of sudden cardiac death.
The most common arrhythmia is atrial fibrillation which affects over 2 million individuals in the United States. The number of new cases grows each year by approximately 170,000 people. Atrial fibrillation accounts for more days of hospitalization the combined total of all ventricular arrhythmias.
Clinicians worldwide have a high interest in evolving the treatment of atrial fibrillation. Today the accepted gold standard surgical therapy for atrial fibrillation is the MAZE procedure. This procedure is complicated and time consuming and therefore has not been well accepted. The Optimaze technology has the potential to greatly simplify the MAZE procedure by creating lesions quickly. Many patients who have mitral heart valve replacement and repair surgery present to surgery with chronic atrial fibrillation. Clinicians worldwide are interested in performing the MAZE procedure on atrial fibrillation patients at the time of their valve surgery.
The Optimaze system uses proprietary fiber-optic catheters and a diode laser to give clinicians a flexible tool to make precise photo thermal lesions quickly during open-heart surgery and can be used as a treatment for cardiac arrhythmias.
Dr. Mehmet Oze, director of Columbia Presbyterian Medical Center's Cardiovascular Institute has noted: "In the past, most patients suffering from atrial fibrillation, the most common cardiac arrhythmia, had limited treatment options, including a time-consuming and complex surgical approach called the Maze procedure, typically an hour-and-a-half long. The Optimaze system can be used by surgeons to perform a modified Maze Procedure in under 15 minutes, and we believe it achieves similar clinical outcomes. We view this technology as an advancement in surgical ablation for the Maze procedure, and believe it holds significant promise for use in future beating-heart and minimally invasive surgical applications. "
Hopefully as this technology continues to be tested in the ongoing clinical trial here in the U.S. the reduction in surgical time coupled with improved patient outcomes will reduce the inpatient stay and resources utilized thereby saving the overall healthcare system dollars.
Automatic External Defibrillator
More than 250,000 Americans die each year from sudden cardiac arrest. Most cardiac arrests are due to abnormal heart rhythms, with ventricular fibrillation (VF) the most common. This condition causes the heart to beat in a chaotic, irregular fashion, causing the heart to stop pumping blood. Death follows within minutes. Defibrillation, providing an electrical shock to restore a heart back to its normal rhythm, is the only known therapy for VF. Unfortunately, for every minute that passes without defibrillation, a victim's chance of survival decreases by 7-10 percent.
At this time, few communities have programs to make emergency defibrillation widely accessible to cardiac arrest victims. Of those that do, some have raised average survival rates for out-of-hospital cardiac arrest to as high as 50 percent. It is estimated that widespread availability and use of automated external defibrillators (AEDs) could save as many as 50,000 lives nationally each year.
The Philips FR2 automated external defibrillator (AED) is portable, lightweight, virtually anyone can be trained to operate this life-saving device for administering first aid immediately to a victim of sudden cardiac arrest, and the FR2 is the only AED cleared for use on people of all ages.
Due to its easy-to-use design, superior technology and affordability, AEDs are now being placed in a wide range of settings such as hospitals and clinics, offices and industrial locations, airports and airplanes, health clubs and golf courses. This innovative AED technology has also enabled a broader range of people beyond community EMS professionals to provide lifesaving therapy.
Other Technologies on Display Include:
|Vascular closure device
||Abbott Vascular Devices
|Cholesterol testing system
|Coronary stents, endovascular grafts for abdominal aortic aneurysms, pacemakers and defibrillators
|Aortic connectors, heart valve replacement devices
||St. Jude Medical, Inc.
|Diagnostic imaging and health information systems
||Siemens Medical Solutions