CORONARY: Off-Pump and on-Pump CABG Give Similar Short-Term Outcomes

From Heartwire > Conference News

The largest study ever to compare off-pump and on-pump CABG has shown no significant difference in 30-day results for the primary end point [1]. Some differences in secondary end points may drive decisions on an individual basis until long-term results are available, suggests the lead author.
The CORONARY study was presented at the American College of Cardiology (ACC) 2012 Scientific Sessionstoday and simultaneously published online in the New England Journal of Medicine.
Lead investigator Dr André Lamy (McMaster University, Hamilton, ON) explained that previous trials and meta-analyses of studies comparing off- pump and on-pump CABG have shown conflicting results, and there is a need for a large high-quality study to settle the issue. "The CORONARY study should do that," he told heartwire .
"Our study should settle the current controversy surrounding off-pump surgery. The recent results suggesting worse outcomes with this approach were probably due to inexperienced surgeons. As off-pump is more technically challenging, you need to be more experienced for this approach, but if the surgeon is comfortable with off-pump, the results seem to be good."

The CORONARY trial randomized 4752 patients in whom CABG was planned to off-pump or on-pump surgery. There was no significant difference in the primary end point, a composite of death, MI, stroke, or new renal failure requiring dialysis at 30 days after randomization. There was also no difference in any of the individual components of the primary end point.

CORONARY: Primary Composite End Point and Individual Components
End point Off-pump (%) On-pump (%) HR (95% CI)
Primary composite end point 9.8 10.3 0.95 (0.79–1.14)
Death 2.5 2.5 1.02 (0.71–1.46)
MI 6.7 7.2 0.93 (0.75–1.15)
Stroke 1.0 1.1 0.89 (0.51–1.54)
New renal failure 1.2 1.1 1.04 (0.61–1.76)
There were, however, some differences in secondary outcomes, with the off-pump group showing advantages of less bleeding, respiratory infections, and acute kidney injury, but this group also had fewer grafts performed and had more revascularizations.

CORONARY: Secondary Outcomes
End point Off-pump (%) On-pump (%) HR (95% CI)
Repeat revascularization 0.7 0.2 4.01 (1.34–12.0)
Respiratory failure or infection 5.9 7.5 0.79 (0.63–0.98)
Acute kidney injury 28.0 32.1 0.87 (0.80–0.96)
Blood transfusion 50.7 63.3 0.80 (0.75–0.85)
Reoperation for perioperative bleeding 1.4 2.4 0.61 (0.40–0.93)

Lamy commented to heartwire : "These secondary findings may have a big impact on long-term follow-up. We are continuing to follow patients for five years, and I think our long-term results will be very interesting."
Consider a Personalized Approach
He suggested that for the time being, either approach could be used. "I would recommend that surgeons train in both methods and consider these results when deciding which method to use for each individual patient. So we are thinking about personalized medicine."
He continued: "For example, if the surgeon were equally competent at both techniques, for an 83-year-old woman of 50 kg and some kidney dysfunction, I might choose off-pump, as that seems to be associated with less transfusion and kidney problems, but for a 62-year-old diabetic smoker with diffuse disease, on-pump may be a better option to get the best revascularization possible."
He added that patients with a calcified aorta are definitely better off getting off-pump, as it is difficult to cannulate the aorta in these cases. "But we often don't know this until they are on the table, so it is good to be trained in both techniques."
Lamy noted that the proportion of off-pump vs on-pump procedures varies with geographical location and individual centers. In the US and Europe, most CABGs are done on-pump now, as this is the easiest method. But in South America, China, and India, off-pump is more popular, probably because it is cheaper not to use a pump.
Surgeon Experience Critical Especially for Off-Pump
He explained that the main factor that can influence outcome is the surgeon's experience in each method, but this is probably more important in off-pump procedures, as this approach is so much more challenging because the heart is still beating. And many previous studies may not have controlled for differences in surgeon experience.

"In our study we insisted all surgeries were conducted by experienced surgeons. They had to have performed at least 100 cases in the approach used. But in fact, we found that the vast majority of surgeons involved in our study were very experienced in both approaches."
Lamy explained that for many years meta-analyses of studies comparing the two strategies have shown similar outcomes for off-pump vs on-pump, with maybe a trend toward benefit of off-pump.

But a large study in 2009--the ROOBY trial--suggested a worse outcome with off pump. And a Cochrane review just published suggested a higher death rate with off-pump.
But Lamy says his study is the best evidence to date and should override both the ROOBY trial and Cochranereview. "With 5000 patients, we have more patients than any other study, and we included 79 centers worldwide, with all cases being done by experienced surgeons. This is very high quality."
He also pointed out that the ROOBY study was conducted only in VA hospitals, which have a high proportion of trainee surgeons. "So expertise would have been lower in this study, which would affect off-pump more."

And Lamy noted that the new Cochrane review included just one additional study to the most recent meta-analysis by Afilalo [2], which showed a trend toward benefit with off-pump. "That one additional study [3], which was conducted by one of the authors of the Cochrane review, was small, with only about 300 patients, and had a very high mortality rate (around 25%) in the off-pump group.
This one study completely skewed the results of the review to suggest harm with off-pump surgery. I would suggest that a more sensible interpretation of that one small study would be that surgeons involved in that study shouldn't be doing off-pump procedures. But our results are far more reliable and suggest that with experienced surgeons, both techniques are similar in terms of short-term outcomes."

Speculating on why off-pump surgery may be associated with some of the better secondary outcomes, Lamy explained that the pump takes away diastolic and systolic blood pressures, instead producing one constant pressure, and this may be responsible for the acute kidney injury. He added that this has also been suggested to contribute to the neurocognitive dysfunction sometimes seen after bypass surgery. The CORONARY trial included a neurocognitive substudy to look at this issue further, but these results are not available yet.

In an editorial accompanying the paper [4], Dr Frederick Grover (VA Medical Center, Denver, CO) notes that the CORONARY trial included higher-risk patients than the ROOBY study, who are thought to derive a greater benefit from off-pump surgery. He concludes that long-term results from the CORONARY trial "should shed more light on this controversial topic and on specific subgroups of patients who might benefit from off-pump CABG."

Heartwire © 2012

Global Cardiovascular Health

Urgent Need for an Intersectoral Approach
Abstract

Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with more than 80% of CVD deaths occurring in low- and middle-income countries (LMICs).
There have been several calls for action to address the global burden of CVD, but there remains insufficient investment in and implementation of CVD prevention and disease management efforts in LMICs.
To catalyze the action needed to control global CVD, the Institute of Medicine recently produced a report, Promoting Cardiovascular Health in the Developing World A Critical Challenge to Achieve Global Health.
This paper presents a commentary of the Institute of Medicine's report, focusing specifically on the intersectoral nature of intervention approaches required to promote global cardiovascular health.
We describe 3 primary domains of intervention to control global CVD:
1) policy approaches
2) health communication programs
3) healthcare delivery interventions.
We argue that the intersectoral nature of global CVD interventions should ideally occur at 2 levels: first, all 3 domains of intervention must be activated and engaged simultaneously, rather than only 1 domain at a time; and second, within each domain, a synergistic combination of interventions must be implemented. A diversity of public and private sector actors, representing multiple sectors such as health, agriculture, urban planning, transportation, finance, broadcasting, education, and the food and pharmaceutical industries, will be required to collaborate for policies, programs, and interventions to be optimally aligned. Improved control of global CVD is eminently possible but requires an intersectoral approach involving a diversity of actors and stakeholders.

Introduction
Cardiovascular disease (CVD) is well established as one of the leading causes of death worldwide, with more than 80% of all CVD-related deaths now occurring in low- and middle-income countries (LMICs). There have been several calls for action to address the global burden of CVD, but there remains insufficient investment in and implementation of CVD prevention and disease management efforts in LMICs.
To catalyze the action needed to control global CVD, the Institute of Medicine has produced a report entitled Promoting Cardiovascular Health in the Developing World: A Critical Challenge to Achieve Global Health.[5] A key feature of the committee's report is that the interventions to control global CVD should be intersectoral, extending beyond the direct domain of the health sector to involve multiple sectors of society, both public and private, and at both the population and individual levels.
This paper presents a commentary of the Institute of Medicine's report specifically related to the intervention approaches that can be pursued, focusing on the intersectoral nature of these interventions that is required to promote global cardiovascular health. Macro-level, intersectoral interventions are often difficult to implement successfully. Therefore, the challenge will be to adopt innovative and robust implementation approaches that take into account specific characteristics of the sociopolitical environment in different countries to find the optimal opportunities for success.

The determinants of the global CVD epidemic are multifactorial. Although the proximate risk factors for CVD are biological (hypertension, dyslipidemia, and diabetes) and behavioral (diet, physical activity, and tobacco), these risk factors are influenced by more "upstream" and "structural" factors such as globalization, demographic change, sociopolitical determinants, social inequality, education, and cultural norms.Thus, an intersectoral approach is required to address the multifactorial etiology of CVD.

Policy strategies at the global, national, and local levels have great potential for creating environments that enable individuals to make and maintain healthful choices. Policy tools include financial, legal, regulatory, and trade measures. Tobacco control is a well-established success story of CVD-related policy and demonstrates the impact possible from adopting an intersectoral approach.
In particular, the World Health Organization Framework Convention on Tobacco Control, the first international treaty dedicated to a health issue, emphasizes the importance of simultaneous implementation of comprehensive tobacco policies. These include taxation on tobacco products, smoking bans in public places, restrictions on tobacco advertising, counteradvertising, regulations on packaging and labeling of tobacco products, public awareness campaigns, health education initiatives, tobacco cessation services, restrictions on tobacco trade and sales, and support for alternative economic activities for tobacco producers. Similar intersectoral policy approaches can be applied to food and agriculture policy, environmental legislation, and urban planning, all of which have profound impact on the choices available to individuals regarding healthy behaviors.
Intersectoral and comprehensive policy approaches are not without their risks and difficulties. Creating collaboration and agreement among different government agencies and institutions is not always straightforward. In addition, developing policy is insufficient: implementation and enforcement is critical and often requires negotiation, compromise, creative financing, and transparent accountability. Despite the successes of the Framework Convention on Tobacco Control, more than 20% of signatory countries have yet to establish a national tobacco-control coordinating mechanism, and implementation of tobacco control policies remains a challenge in many countries.

Health communication programs, which enhance the knowledge, motivation, and skills of individuals and their communities, are by necessity intersectoral, involving multiple partners and stakeholders. Health communication initiatives can involve the mass media and other large-scale public communication strategies as well as communication programs implemented in community settings.
Successful communication programs recognize that health behaviors are influenced by socioeconomic, political, and cultural factors, and that interventions are required at multiple interdependent settings and levels. Thus, a combination of mass media, social marketing, community mobilization, empowerment and participatory approaches, enhancement of knowledge and behavior diffusion networks, and access to healthy choices can potentially maximize individuals' capacity to act on increased knowledge and awareness. For instance, community-based health communication interventions related to dietary changes are especially successful when individuals simultaneously have increased access to healthy food choices. Targeted communication strategies that are coordinated and aligned with the implementation of policy strategies have the potential to not only promote healthy behaviors but also build public support for policy changes. However, care must be taken in targeting, designing, and implementing both mass media and community-based health communication initiatives, as the evidence for the effectiveness of targeting multiple risk factors and affecting cardiovascular disease outcomes is not conclusive, and there have been limited evaluations in LMICs.
Evaluation of communication efforts in both mass media and community settings, as well as further research using innovative and novel communication strategies, are required to determine the optimal approach in LMICs.

Interventions to improve healthcare delivery—such as strengthening health systems, improving quality of care, optimizing human resources for health, establishing secure supply chains of drugs and technology, and promoting equitable access to care—are crucial to improve the preventive, diagnostic, therapeutic, and rehabilitative services available to the population. Rather than focusing on vertical, disease-specific programs, a "diagonal" approach should be pursued in which CVD-related healthcare delivery should be integrated into a broad-based approach to health systems' strengthening and promotion of primary care services.
Involvement of multiple stakeholders, including the private sector such as pharmaceutical and device companies, will be required to work toward equitable access to affordable health services, essential medicines, diagnostics, and technologies for prevention and treatment of CVD.
To maximize the effectiveness of interventions to improve healthcare delivery (both clinical and behavioral), they should be implemented in the context of broader population-level policy changes and community-level programs.

In summary, each domain of intervention—policy approaches, health communication programs, and healthcare delivery—is likely to have maximal positive impact when an intersectoral approach is undertaken. In addition, the effectiveness of these 3 domains of intervention can be further enhanced when interventions are synergistically linked across domains and mutually reinforced.
Thus, coordination of interventions among these 3 domains is critical to creating enabling environments, maximizing healthy choices, and empowering individuals to adopt health-promoting behaviors. Given the significant and growing burden of CVD in LMICs, and in light of the upcoming United Nations high-level, head-of-state meeting at the General Assembly in September 2011, which will focus on chronic noncommunicable diseases, it is particularly timely and important to recognize the need for intersectoral interventions to promote cardiovascular health as a critical component of global health initiatives in general.

Source: J Am Coll Cardiol. 2011;58(12):1208-1210. 2011 Elsevier Science, Inc.

Cooling May Benefit Children After Cardiac Arrest

When the heart is stopped and restarted, the patient's life may be saved but the brain is often permanently damaged. Therapeutic hypothermia, a treatment in which the patient's body temperature is lowered and maintained several degrees below normal for a period of time, has been shown to mitigate these harmful effects and improve survival in adults.

Now, in the first large-scale multicenter study of its kind, physician-scientists are evaluating the effectiveness of the technique in infants and children. Offered in the greater New York metropolitan area solely by Columbia University Medical Center researchers at NewYork-Presbyterian/Morgan Stanley Children's Hospital, the Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA) trial is funded by the National Heart, Lung and Blood Institute, part of the National Institutes of Health.

"A tragedy no matter how it happens, cardiac arrest can occur in children either as a complication from a serious medical condition or due to an accident or sudden illness. While arrest in children is rare, currently no other therapies have been shown to improve their chances of recovering," says Dr. Charles Schleien, a pediatrician and anesthesiologist at NewYork-Presbyterian/Morgan Stanley Children's Hospital and executive vice chairman of pediatrics and professor of pediatrics and anesthesiology at Columbia University College of Physicians and Surgeons. "In this study we are aiming to see whether therapeutic hypothermia can give these children a better chance at survival and long-term quality of life."

According to a 2008 review of pediatric cardiopulmonary resuscitation in the journal Pediatrics, about 16,000 children suffer cardiac arrest each year in the United States.

Study participants will be randomly selected to either have their body cooled through therapeutic hypothermia or maintained at normal body temperature. In both groups, body heat will be adjusted using special temperature-control blankets. Those receiving hypothermia will have their body temperature reduced to between 89.6º and 93.2º Fahrenheit for two days, then slowly increased to a normal body temperature and maintained for another three days.

Co-led by Dr. Frank W. Moler at the University of Michigan C.S. Mott Children's Hospital and Dr. Michael Dean at the University of Utah, the six-year study involves a total of 34 study sites in North America.

Cardiac Arrest and Therapeutic Hypothermia

During cardiac arrest, the body's blood supply is interrupted and cells are deprived of oxygen. This stresses the body, causing the release of toxic compounds that can overwhelm the organs and result in long-term brain injury. Therapeutic hypothermia slows the body's production of these compounds, reducing risk for brain injury. The therapy has been used successfully in adult cardiac arrest patients and has been shown beneficial for newborns who have received insufficient oxygen at birth.

Source: NewYork-Presbyterian Hospital

The Year's Major Event In Cardiovascular Medicine: ESC Congress 2010

The European Society of Cardiology Congress 2010, the world's biggest international meeting in Cardiology will be held in Stockholm, Sweden, from 28 August to 1 September 2010.

The spotlight of ESC Congress 2010 will be coronary artery disease (CAD), 'from genes to outcome', which the chairperson of this year's program committee, Professor Fausto Pinto, describes as still the number one cause of death in the developed world. 'What we'll be seeing in this year's program,' he says, 'is how developments in basic science are now being translated into clinical progress in the early diagnosis and treatment of CAD. This is an area which involves the laboratory and the clinic, and a range of specialists which includes technicians and nurses, family doctors and consultant cardiologists. They will all play a part in this year's program.'

Last year's ESC Congress in Barcelona attracted almost 32,000 registered participants (as well as 750 registered press), making it the largest medical meeting in the world; this year's event promises a similar attendance.
New fpr 2010 is a one-day program on Saturday 28 August for primary care physicians and nurses. The program is open to all but has been designed with Scandinavians in mind, and this too may provide much local interest. The congress's opening press conference will also take place on this Saturday, at 9.00 am.
ESC Congress 2010 promises once again to be the world's major event in cardiovascular medicine.

Source:
ESC Press Office
European Society of Cardiology

ESC Supports 'appropriate' Use Of Nuclear Imaging Technology

Cardiac nuclear imaging and computed tomography angiography (CCTA) still have an important role to play in cardiac disease diagnosis, say experts from the European Society of Cardiology (ESC).

Following the recent publications (1,2,3) highlighting potential dangers of ionising radiation resulting from imaging testing, the ESC experts feel that it is important to voice support of the technology. "We want to reassure the public that for individual patients the benefits of receiving an accurate diagnosis are likely to far outweigh the small potential risks involved in having a scan," said Professor Juhani Knuuti, of the ESC Working Group on Nuclear Cardiology and Cardiac CT, from Turku University Hospital (Turku, Finland). "The most fundamental question that clinicians need to ask themselves is whether a test is appropriate for the individual patient, and whether that patient will derive benefit from it."

It needs to be remembered, he added, that tests like CCTA are used to select patients for invasive procedures that themselves carry risks. "Any procedure is a balance of risks and benefits. What has been overlooked in recent publications is the risk of cardiovascular disease going untreated, which can even result in immediate sudden death. The potential risks of imaging tests are small relative to the diagnostic information obtained," said Knuuti.

"We have real concerns that following the publicity around the papers, the public may avoid these tests out of fear and that authorities might create unjustified recommendations for imaging use. They need to appreciate that radiation is a single aspect of the risks involved, and that these are really useful tests for cardiologists. Everything needs to be considered in the wider context," said Knuuti.

Papers highlighting the risks

Last year the problems of radiation exposure in patients undergoing medical imaging procedures were raised in three papers in major journals.

A Science Advisory statement from the American Heart Association Committee on Cardiac Imaging wrote that between 1980 and 2006 the collective dose from medical uses of radiation received by the US population increased by more than 700%. The paper, published in Circulation, added that in 2006 CTTA accounted for around 50 % of the collective dose(1).

A NEJM paper, by Reza Fazel and colleagues, from Emory University School of Medicine (Atlanta, Georgia), reviewed the radiation exposure of nearly one million US adults, aged 18 to 64(2). The investigators found that 69 % of participants had undergone at least one imaging procedure associated with radiation, and that the mean cumulative dose was 2.4 mSv per subject per year. "Our finding, that in some patients worrisome radiation doses from imaging procedures can accumulate over time, underscores the need to improve their use," wrote the authors, adding that strategies for optimizing and ensuring appropriate use of the procedures in general should be introduced.

A paper in JAMA by Jorg Hausleiter and colleagues, from Klinik an der Technischen Universitat, (Munich, Germany) reviewed the radiation dose of CCTA from 50 study centres(3).Results revealed an estimated median radiation dose corresponding to 12mSv, and furthermore found a six fold difference in the dose delivered between the highest and lowest centres. "Improved education of physicians and technicians performing CCTA on these dose-saving strategies might be considered to keep the radiation dose 'as low as reasonably achievable' in every patient undergoing CCTA," concluded the authors.

Radiation exposure risks put in context

It is important", said Knuuti, for the public to try to achieve an understanding of exactly what the potential increased cancer risk might involve. "The difficulty involved here is that the risks are so small that you'd never be able to detect them in clinical trials unless you recruited millions of subjects and followed them for the rest of their lifetimes," said Knuuti, adding that the current risk estimates have been derived from studies of atomic bomb survivors.

One study that helps put the risk of imaging into perspective suggests that living with a smoker (i.e. being a passive smoker) causes a 20 times higher risk of fatal cancer(4) than undergoing one CCTA scan (10 mSv). Another study suggests that the risk of having a fatal pedestrian traffic accident is three times higher than the risk of developing fatal cancer after one CCTA scan(5).

Cancer risks also need be considered in relation to the patient's age at the time of undergoing the investigation. "For patients with chest pain over the age of 60 years the radiation risks involved are unlikely to have consequences since it takes anyway decades to develop potential adverse events," said Knuuti, adding that the estimated risks would be greater for younger patients.

The way forward, said Knuuti, is to introduce strategies that reduce the radiation dose received by patients undergoing investigations. The PROTECTION 1 study, for example, showed that reducing the tube voltage from 120 kV to 100 kV resulted in a 53 % reduction in the median radiation dose for CCTA(6) "In the last five years the radiation dose from CCTA has been reduced from 20 to 30 mSv to 1-5 mSv. So the current dose is much lower than these papers are leading us to believe," he added.

Furthermore, additional efforts need to be undertaken to ensure appropriate use of imaging tests in different patient populations. "Studies undertaken in the US have suggested that one third of tests are being undertaken in patients where there is not a good indication," said Knuuti.

Source: European Society of Cardiology (ESC)

Tiny heart pump

Cardiologists at the University of Illinois Medical Center are using a new heart pump that can be inserted without the need for surgery and allows them to treat high-risk patients with a procedure to unblock their heart arteries.

The recently FDA-approved device was used to assist in three angioplasty procedures at the Medical Center last week.

Patients with the worst blockages are often the sickest, making it too dangerous to treat their coronary artery blockages with standard angioplasty or even with a bypass operation, says Dr. Adhir Shroff, assistant professor of cardiology at the UIC College of Medicine.

Shroff and his partners, Dr. Mladen Vidovich, assistant professor of cardiology, and Dr. John Kao, assistant professor of medicine, performed these procedures using the Abiomed Impella 2.5 ventricular assist device, which has been used only about 1,000 times in the country.

"Often these patients, who may have complicating conditions like cancer, renal failure, severe lung disease, or heart failure, are poor candidates for more invasive procedures like bypass surgery and are left with few options," said Shroff. "We only proceed with high-risk angioplasties after reviewing the patients with our heart surgeons."

Angioplasty is done by threading a thin, flexible tube, or catheter, into the coronary arteries through a small opening in a leg artery. It is much less invasive than open heart surgery, but has been largely restricted to managing low- to middle-risk patients.

The Impella heart pump makes it possible for cardiologists to offer the less invasive procedure to high-risk patients. "Our ability to continuously maintain blood flow will decrease complications during these high-risk cases where the patient had no other options to fix their heart arteries," Shroff said.

The Impella system uses a narrow catheter, which is threaded up from the groin, through the ascending aorta, and into the left ventricle. From this position, the Impella pumps blood from within the heart into the aorta, supplementing the weakened pumping of the patient's heart. The pump itself is smaller than a number-2 pencil eraser. Although it provides a large portion of the heart's work, it is silent and virtually imperceptible to the patient.

The Impella can be regulated during angioplasty to maintain blood flow, giving the physician the time needed to remove the blockage. If the patient needs further support, the Impella can be continued while the patient moves up to the ICU and until the heart is able to take on the task.

"We have created a seamless transition from the cath lab to the ICU," Shroff said. "We could not have done this without the collaboration of everyone who sees these patients as they move through the hospital, from the emergency room to the cath lab to the ICU. This exceptional effort on everyone's part, especially Nursing Services and the Cath Lab staff, allows UIC to offer the best possible care for patients with heart disease."

Source: University of Illinois at Chicago

World First New DeBakey VAD impanted in Heidelberg

At the end of July 2009, a team of cardiac surgeons headed by Professor Dr. Matthias Karck, Director of the Department of Cardiac Surgery at Heidelberg University Hospital, was the first in the world to implant the HeartAssist 5 ventricular assist device, the modern version of the DeBakey VAD. The device augments the pumping function of the left ventricle in an especially effective, gentle and quiet manner. The pump weighs 92 grams and is made of titanium and plastic. It pumps blood from the weakened or failed left ventricle into the aorta.

"Following the 3.5 hour surgery, the patient is doing fine," reports Professor Karck. The 50-year-old woman suffered from heart failure that could not be effectively treated with medication. Since a heart transplant was not an option due to medical reasons, the implanted heart pump will now assist her heart permanently.

Bridging the waiting time for a heart transplant

"The heart pump can also be used as a bridge-to-transplant while the patient waits for a matching donor heart," says Dr. Arjang Ruhparwar, senior registrar in the Department of Cardiac Surgery in Heidelberg. When a donor heart becomes available, the pump and the diseased heart are both removed and replaced by the new donor heart.

The DeBakey VAD was first developed in the 1990s in cooperation with NASA by Professor Michael DeBakey, the renowned American cardiac surgeon at the Baylor College of Medicine in Houston, who died in 2008 at the age of 99. The modern version of the device, the HeartAssist 5, is manufactured by US company MicroMed Cardiovascular. It is considered to be a fifth generation VAD because it can be implanted adjacent to the heart and has an exclusive flow probe that provides direct, accurate measurement of blood flow from the left ventricle to the aorta. The new miniature device is light, easy-to-handle and can be monitored and controlled externally.

Patients can live a normal life at home

"The new device has great advantages - at only 92 g, it is the smallest and lightest approved VAD in Europe that can completely replace the function of the left ventricle and it works very quietly and effectively with a high flow coefficient," explains Professor Karck. Thus, patients are able to live a nearly normal life at home.

In Europe, the HeartAssist 5™ has CE Marks for both adult and pediatric use. In the U.S., the HeartAssist 5, formerly DeBakey VAD® Child, is the only FDA-approved pediatric VAD. A bridge-to-transplant IDE clinical study is currently underway in the U.S. for adults.

Source:
Dr. Matthias Karck
University Hospital Heidelberg