CryoCath Initiates Patient Enrollment in Atrial Fibrillation Study
Toolbox Approach to Treat AF Makes Successful U.S. Debut
CryoCath Technologies Inc. announced that it has enrolled and treated its first patient in its Investigational Device Exemption (IDE) study for atrial fibrillation (AF). The study involves a unique “toolbox” approach to treat AF using up to three different CryoCath catheters: Arctic Circler™, Freezor® Xtra and Freezor® MAX. The study is designed to take place in two stages. In the first stage, the company will enroll up to 30 patients at three U.S. centers.
Dr. Vivek Reddy of Massachusetts General Hospital in Boston, Dr. Jim Irwin of St. Joseph’s Hospital in Tampa and Dr. John Seger of St. Luke’s Episcopal Hospital at the Texas Heart Institute will participate as clinical investigators in the first stage, with Dr. Reddy acting as the principle investigator.
Dr. Irwin treated the first patient enrolled in the AF study on November 12, 2003. In July 2003, St. Joseph’s Hospital was also one of the first centers to use the Freezor CryoAblation System in the U.S. Since then, St. Joseph’s has used the system to treat nearly 60 patients with a variety of arrhythmias, including AVNRT, AVRT and atrial tachycardia.
With an average of four cryo-applications per vein, the initial AF study case resulted in all four pulmonary veins isolated with the Arctic Circler catheter alone. Per the protocol of the study, the Freezor MAX successfully (confirmed by bi-directional block) created a flutter ablation line (six cryo-applications) to avert an occurrence of atrial flutter, often present with or as a consequence of treating AF. Total procedure time for both ablation procedures was approximately 3.5 hours.
“I was ecstatic with the success of this particular case and very impressed with both the Arctic Circler and Freezor MAX. Moreover, the timeframe of the procedure now makes ablating AF a clinically viable option,” said Dr. Irwin. “Like many of my colleagues, the majority of my patients have AF, yet to date, there has been no safe and effective devices to address the disorder. The potential to bridge this technology gap is why I am enthusiastically participating in this important study.”
The company expects to expand the number of centers participating in the study. Subsequent to follow-up of Stage I patients, and based on acceptable safety and acute success rates, an additional number of patients will be enrolled in the second stage of the trial to generate the data required to submit a Pre-Marketing Approval application to the FDA. The final protocol for the second stage will be determined early in 2004 after the FDA has issued its AF trial guidance document.
“Starting the IDE study is an important development milestone that brings us closer to commercializing an AF catheter in the US. It will complement our surgical probe, SurgiFrost®, which currently is routinely used to ablate cardiac arrhythmias including AF,” said Steven G. Arless, President and CEO of CryoCath. “Dr. Irwin’s positive experience reflects the encouraging results we are getting across Europe with Arctic Circler and leads us to believe our AF cryoablation franchise positions CryoCath to become the dominant player in AF ablation.”
Toolbox approach. Arctic Circler, uniquely configured to treat AF originating in the pulmonary veins, has the ability to create curvi-linear lesions rapidly within the ostia (openings) of the four pulmonary veins (PV). Freezor Xtra will touch up gaps, if necessary, resulting from unique PV anatomy. Freezor MAX will be used to create a flutter ablation line in all AF patients regardless if atrial flutter is present or not.
AF is a disorder of the heart characterized by rapid and chaotic beating of the atria and is the most prevalent cardiac arrhythmia, affecting four million patients in the western world. AF is one of the leading causes of stroke and short-term hospitalizations, with 400,000 new cases annually. Despite its prevalence, there are no current or practical clinical options to effectively and safely treat AF. Catheter ablation to resolve AF’s underlying cause, aberrant electrical signals originating on the left side of the heart near or within the pulmonary veins, has been restricted by safety concerns. As a result, the standard treatments for AF are limited to various costly drug regimens that offer only a palliative, non-curative approach.
Sentara Network in Virginia Nears Completion of PACS Implementation
Meeting its strategic goal to be a leading-edge healthcare provider with a commitment to technology, Sentara Healthcare is now completing its Agfa IMPAX® PACS (Picture Archiving and Communications System) implementation across a network of five member hospitals in southeastern Virginia. Sentara signed a contract with Agfa in June 2002 for the installation of the Agfa IMPAX PACS at Sentara Norfolk General, Sentara Bayside, Sentara Leigh, Sentara Virginia Beach General, and Sentara CarePlex Hospital.
The Sentara IMPAX implementation not only meets the PACS needs of the Sentara member hospitals, it connects them in a single database through the Agfa IMPAX WEB1000™. The project has included workflow benchmarking across the enterprise, facilitating technology deployment and workflow reengineering to achieve increased productivity and lower costs.
“This successful IMPAX implementation for Sentara, completed in near record time, makes it a national model for enterprise-wide PACS management of health information for a large integrated health delivery network,” notes Michael Green, Vice President of Global Marketing for Agfa HealthCare.
The Sentara installation also features Agfa's IMPAX for Cardiology™, an integrated image and information management solution designed to enhance cardiologists' workflow, offering on-demand multimodality access to images, data analyses and reports. As the implementation is completed, it will enable complete universal views of images from radiology and cardiology across each institution and network — an important step in standardizing clinical care image services across the enterprise.
As the Sentara healthcare network in Virginia completes the transition from a film-based to a digital environment, its member institutions are poised to realize its benefits, most notably, improved service to referring physicians and consolidation of the patient image repository.
Sentara Healthcare, a not-for-profit healthcare provider in southeastern Virginia and northeastern North Carolina, is comprised of more than 70 sites of care, including six acute care hospitals, a hospital for extended recovery, two outpatient care campuses, seven nursing centers, three assisted-living centers, and 25 primary care practices. Sentara also offers a full range of health coverage plans, home health and hospice services, physical therapy and rehabilitation services, mobile diagnostic vans, and ground and air medical transport services. Sentara was ranked the number one integrated healthcare network in the United States in 2001 by Modern Healthcare magazine and is the only healthcare system in the nation to be named in the top 10 for five consecutive years.
Irregular Rhythm Ups Death Risk in Heart Patients
Irregular heart contractions involving the upper chambers of the heart (atrial fibrillation, or AF) independently predicts one-year mortality in patients who undergo heart surgery following a recent heart attack, according to a recent report. This is the first study to evaluate the impact of AF in heart attack patients who underwent heart surgery, the authors explain.
Dr. Hiroshi Sato from Osaka University Graduate School of Medicine, Suita, Japan and colleagues in the Osaka Acute Coronary Insufficiency Study Group determined the rate and future impact of AF on in-hospital and one-year mortality in 2,475 heart attack patients who underwent surgery. The 297 patients (12.0%) with AF during their heart attack were older and more often had had a previous heart attack, multivessel disease, and other poor prognostic factors than did the patients who did not have AF with their heart attack, the report in the American Journal of Cardiology indicates.
Patients with AF experienced cardiogenic shock, congestive heart failure, cardiac rupture, ventricular arrhythmias, and stroke more than patients without AF, the authors report, but AF was not associated with increased in-hospital mortality after adjustments were made for demographic characteristics and clinical factors. In contrast, one-year mortality was significantly higher in patients with AF than in patients without AF. The researchers note that patients with AF faced a 2.82-fold increased risk of death, compared to patients without AF.
After adjustment for demographic and clinical factors, AF during hospitalization was independently associated with a three-fold increased risk of one-year mortality, the investigators report, though AF at hospital admission was not associated with a significantly increased one-year mortality.
No treatments were shown to modify one-year mortality in these patients, due to the small size of the study sample, Sato said. Further studies are needed to examine whether control of heart rhythm improves mortality in heart attack patients with AF, Sato concluded. The “main message” of the study was that because long-term prognosis was significantly worse in heart attack patients with AF than in those without, “patients with AF may be targeted for more aggressive treatment.”
St. Jude Medical Wins FDA Approval of the Housecall Plus™ Remote Patient Monitoring System, Advancing Care with Transtelephonic Technology
St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval of the St. Jude Medical Housecall Plus™ remote patient monitoring system. The system enables a physician to evaluate and communicate with an implantable cardioverter defibrillator (ICD) patient in real time, even if the two are thousands of miles apart.
“The transtelephonic ICD follow-up provided by the Housecall Plus™ system is more comprehensive, less intrusive and more desirable than routine follow-up visits,” said Bruce L. Wilkoff, MD, from The Cleveland Clinic in Cleveland, Ohio. “Patients consider this follow-up more than acceptable and indicated high degrees of satisfaction with the convenience, ease of use and reliability of transtelephonic monitoring.”
The Housecall Plus™ remote monitoring system currently supports the St. Jude Medical Atlas®, Epic™ and Epic™+ families of ICDs. In the future, the system will be enabled to function with all future St. Jude Medical ICDs and pacemakers.
Unlike other remote ICD monitoring systems that only store limited data for review at a later time, the Housecall Plus™ system offers a live medical professional to monitor the transmissions immediately and communicate with the patient. “The St. Jude Medical Housecall Plus™ system is the only remote monitoring technology that provides physicians with both real time and stored data, two critical factors in evaluating ICD patients,” said Michael J. Coyle, President of St. Jude Medical’s Cardiac Rhythm Management business. “Because the system uses live operators, patients can feel more secure knowing they are just a dial-up away from medical advice. Physicians can minimize the number of in-office visits for routine follow-ups and system checks, and unwarranted trips to the emergency room can be avoided.”
The small transmitter, about the size of a telephone answering machine, can be kept on a patient’s table at home or on a desk at the office. It connects to a standard telephone line and electrical outlet. The transmitter communicates with the receiver, which may be in a physician’s office or at a monitoring center. Either the patient or the physician can initiate the call to transmit up-to-the-second information about how the patient’s heart and ICD are functioning. A built-in speakerphone allows the medical professional to guide a patient through the simple transmission process. The receiver then provides the capability to monitor signals and settings on the ICD, evaluate real-time electrograms, surface ECGs, delivered therapies and stored electrograms. The complete diagnostics available in the Housecall Plus™ system are equivalent to a full, in-office programmer-based interrogation.
While the system does not eliminate the need for doctor visits, it offers important insights into when a patient should be seen. As a result, it can boost clinical office productivity, allowing a physician to manage ICD patients with greater efficiency.
Depression May Not Cause Heart Problems
New research suggests that depression does not cause heart attacks or related problems in patients with heart disease. Multiple studies have described strong associations between depression and heart problems in people with heart disease. However, lead author Dr. Ralph A. H. Stewart, at the University of Auckland, New Zealand, and colleagues suggest that many of these studies only looked at the period soon after a heart attack or other cardiac event. Their research was recently published in the European Heart Journal.
Theorizing that depression is merely a marker for increased risk attributable to other factors, Stewart’s group assessed depressive symptoms in 1,130 individuals several months after the cardiac event occurred. At the start of the study, 22 percent of subjects had depressive symptoms. During a follow-up period of around eight years, there were 114 cardiac-related deaths, 108 nonfatal heart attacks, 53 nonfatal strokes, and 274 cases of severe chest pain.
After accounting for the subject’s age, gender, and geographic location, the authors observed no association between depressive symptoms and cardiac deaths. There was a modest association with nonfatal heart events, the report indicates, and a strong association between depressive symptoms and certain heart symptoms. After factoring in the effects of heart disease risk factors, socioeconomic variables and symptoms of heart disease, there was no evidence of an association between depressive symptoms and prognosis, they report.
However, even if depression doesn’t directly cause heart problems, depression in medically ill patients should not be ignored, notes Dr. Jurgen Unutzer, a psychiatrist at the University of Washington in Seattle. In reviewing the report, Unutzer said that the team used a brief screening test to assess depressive symptoms at one point in time. “It would be helpful to see if the patients met the clinical diagnostic criteria for depression.”
Unutzer agrees with the researchers’ assertion that large randomized clinical trials are needed to further explore the link between depression and heart problems. Regardless, treatment for depression is important in and of itself, because depression causes “tremendous decreases in quality of life and functional impairment in any group of patients with chronic illness,” he said. “Treating depression makes a huge difference in quality of life and function.”
Agfa and Heartlab Announce Plans to Form Global OEM Relationship
Agfa Sets Sights on Leveraging Proven Heartlab Technology to Deliver a Superior Cardiology Offering
Agfa, a leader in enterprise-wide digital imaging, and Heartlab, Inc., highly regarded for its development of market-leading cardiac image and information management software, announced their intent to collaborate on Agfa’s next generation of IMPAX for Cardiology, with a commercial-ready solution expected early in 2004.
Through the intended OEM agreement with Heartlab, Agfa will give healthcare facilities the ability to implement their enterprise strategy using industry-leading solutions, a strategy that can only be realized with tight integration between the two most image intensive departments — cardiology and radiology.
“The combination of our individual strengths will ultimately deliver to our customers the most technically advanced solution available,” says Philippe Houssiau, General Manager of Agfa HealthCare. “We expect this OEM relationship with Heartlab to accelerate the adoption of Agfa’s IMPAX for Cardiology solution and be a core element of our Enterprise growth strategy.”
Heartlab’s technology provides access to and management of patient data from multiple imaging modalities including angiography, cardiac ultrasound and intravascular ultrasound. The technology also enables non-image data including waveforms and clinical reports to be part of the patient’s clinical record.
“We are very enthusiastic about working with a global partner with Agfa’s scope and depth of experience in PACS,” commented Robert Petrocelli, CEO, Heartlab Inc. “We are excited about the prospect of including Heartlab’s technology to Agfa’s Enterprise offer. This strong relationship further establishes Heartlab’s technology as the standard for cardiology image and information management.”
Good Things in Small Packages: Small Community Hospital Becomes Leader in Enterprise-Wide Implementation and Integration
Spearheaded by Agfa technology and driven by an institution-wide strategic vision, 100-bed Exeter Hospital in New Hampshire has become one of the first hospitals in the nation to boast a medical imaging system that is fully implemented throughout the enterprise, interfacing with the existing hospital information system and integrated into a hospital-wide EMR.
Nearly two years ago, as the result of strong institutional leadership planning, Exeter was among the first hospitals to install the full breadth of Agfa’s leading-edge IMPAX® PACS (Picture Archiving and Communication System) offerings including:
• IMPAX PACS, providing a single common database, architecture and infrastructure for radiology & cardiology;
• IMPAX for Cardiology™;
• IMPAX Cardio 3000™ (multi-modality workstation);
• IMPAX WEB1000™ software with interface to the Meditech Client/Server EMR application;
• EMC Corporation’s Centera™, a software-driven storage architecture;
• Agfa’s ADC (Agfa Diagnostic Center) computed radiography system.
Since that time, Exeter has steadily expanded its commitment to the latest technology by upgrading IMPAX to include cardiology viewing support with the MPEG viewer, Microsoft SQL Server 2000™ support, Microsoft Windows 2000™ OS support, MR/CT Navigation Scout support, Agfa’s EPR Suite™ that allows end users to access clinical image data through the existing information system onsite.
From the start of the implementation process, the decision to go with Agfa’s digital technology was part of a comprehensive Exeter strategy: the integration of PACS with the hospital’s existing IS network and the eventual creation of a single-hospital-wide EMR. David Briden, CIO at Exeter, who directed the product search team and who serves on the PACS implementation team, observes: “We believed the Agfa system best fit our vision of a medical imaging system that would support the entire medical staff. Nearly every week, I receive a direct compliment by a physician telling me how the system has allowed faster access to images or has enabled collaboration in ways that were impossible before we had IMPAX. Our diagnostic imaging and cardiology departments were quick to embrace our new technology, and have been effective ambassadors to the rest of the organization.”
“Exeter Hospital approached PACS with strong hands-on involvement by the IS group,” notes Michael Green, Vice President Global Marketing, Agfa HealthCare. “We are increasingly seeing that kind of innovative IS leadership in healthcare institutions that are seeking successful enterprise solutions as well as increased cost-effectiveness and workflow efficiencies.”
In May 2003, Exeter Hospital completed construction of its new Outpatient Care Center, and is currently in the midst of a hospital expansion project slated for completion in 2005. That plan includes doubling the size of the emergency room, expanding the radiology and cardiology departments, and adding a second CAT scanner along with a fixed MRI, CR and digital radiography rooms. Mammography, Ultrasound and X-ray capabilities will be added to the new Outpatient Care Center, concurrent with the initial implementation of the IMPAX system.
Researchers Find First Heart Attack Gene
The first gene linked directly to heart attacks has been isolated from an extended Iowa family that has been plagued for generations with rampant coronary artery disease. The gene, called MEF2A, plays a role in protecting the artery walls from building up plaque that can impede blood flow and lead to heart attacks, said Dr. Eric J. Topol of The Cleveland Clinic, the head of a team that discovered the gene.
“This is the first heart attack gene,” said Topol. “Everyone who has this gene mutation is destined to have the disease. If you don’t have this gene in this family, you appear to free from developing this disease.”
A report on the discovery was in the journal Science. Topol said that his team analyzed the genes of about 100 members of an Iowa family where heart disease and heart attack have been common for generation after generation. They found that members of the family with heart disease had a MEF2A gene that lacked some key bits of DNA. This apparently causes the arteries to thicken and become clogged.
It will take more study to determine if MEF2A plays a role in heart disease among people outside of families where the mutation is inherited. The gene makes a protein that regulates some other genes and Topol said those will now be analyzed to see if they can be linked generally to heart disease.
Guidant Gets FDA OK for Expanded Defibrillator Use
Guidant Corporation said it received U.S. regulatory clearance to expand use of its defibrillators for heart failure patients who are at risk of sudden cardiac death due to a prior heart attack and reduced pumping ability. The company said the expanded indication extends the use of the defibrillators to heart failure patients who have not yet experienced a life-threatening arrhythmia, but whose hearts have trouble pumping.
Previously, Guidant’s resynchronization defibrillators were approved only for those heart failure patients who had spontaneous or induced life-threatening arrhythmias, or abnormal heart rhythms. Resynchronization defibrillators shock the heart back into normal rhythm every time it becomes abnormal, getting the lower chambers of the heart to work in tandem.
Guidant’s third quarter sales of all types of defibrillators were $385 million, up 48 percent. Each expanded indication could increase sales. A normal heart will eject about 55 percent of the blood that’s in it, Smith said. The approval allows cardiologists to implant the device in patients whose hearts are ejecting 30 percent or less.
“With this approval, we can affect the quality of their lives not just the duration of their lives,” said Joe Smith, Chief Medical Officer for Guidant’s Cardiac Rhythm Management Unit. Smith said that implanting resynchronization defibrillators can eliminate discomfort that people with abnormal heart rhythms feel. Guidant will now market its resynchronization defibrillators for heart failure patients with damaged pumping ability, even if their heart attack was not recent.
The approval for expanded use, granted by the U.S. Food and Drug Administration, is also important because medical device makers have had a difficult time convincing the U.S. Medicare office to reimburse for defibrillators treating a wide population of patients. In conjunction with the American Heart Association annual meeting in Orlando, Guidant also said it would sponsor a large, new clinical trial testing its defibrillators for patients who have had a heart attack but whose ensuing symptoms have been less severe.
Public Defibrillators Deemed Not Cost Effective
Locating automatic external defibrillators (AEDs) in major transit hubs to revive people who go into cardiac arrest is excessively expensive in terms of the number of quality-adjusted life years (QALY) gained, Scottish investigators report. Moreover, reports a second group, equipping police and firefighters with AEDs does not substantively increase survival after cardiac arrest.
Dr. Jill P. Pell, with the Scottish Ambulance Service Headquarters in Edinburgh, and colleagues determined the economic efficiency of locating defibrillators in all major airports, railway stations, and bus stations in their country. They documented cardiac arrests and outcomes at these sites, then predicted the potential for public AEDs to improve survival by applying data from patients treated within three minutes by ambulance staff. Included were 17 sites, where 31 AEDs would be deployed altogether. Between 1991 and 1998, there were 38 cardiac arrests that actually occurred at these sites, translating to 5.4 annually.
Their estimations, reported in the British Medical Journal, reveal that survival to hospital admission would increase by nearly 14 percent per year, but that survival to hospital discharge would increase by only 2 percent. The intervention would lead to gains of 5.7 life years per survivor and 4.5 QALYs per patient. The cost per life year gained was nearly $50,000. The cost per QALY was $69,000. According to the authors, these exceed British and U.S. standards for cost-effectiveness. Pell’s group suggests that other population-based interventions would be more effective, such as training first responders in AED use and installing AEDs on large commercial aircraft.
However, findings of a team led by Dr. Anouk P. van Alem, at the Academic Medical Center in Amsterdam and reported in the same issue of BMJ, suggest that training first responders doesn’t live up to expectations. They conducted a trial in which AEDs were randomly given to police and firefighters in four of eight participating regions in the Netherlands. In a comparison, or “control” group, ambulances were only supplied with manual defibrillators. Each region switched between the control and the experimental condition every four months for 24 months.
A total of 243 cases of cardiac arrest occurred during experimental conditions and 226 during control conditions. The first shock was delivered in less than five minutes after the call was placed in 9 percent of patients in the experimental group and in 1 percent of the control group. Eighteen percent of patients survived to hospital discharge in the experimental group, versus 15 percent in the control group.
“Delay in time to call, duration of call handling, and delay in dispatching severely reduce the potential benefit of dispatched first responders,” van Alem’s team maintains. An AED program “must focus on optimizing the civic response and the dispatch process.”
However, both groups’ findings contrast significantly with previous reports on this topic. For example, one recent study showed that availability of public-access AEDs led to a 1-year survival rate of 56% after cardiac arrest. A second study found that AED deployment was associated with an annual cost of $30,000 per QALY. A third trial showed that survival rate increased from 9 percent to 17 percent when police were equipped with AEDs.
Pell’s group cites the American Heart Association as recommending that AEDs not be deployed until cost-benefit analyzes are completed. However, Tagni McRae, Communications Manager for the American Heart Association, said that the AHA 2000 guidelines recommend AEDs be made accessible if “there is a reasonable probability of one AED use in 5 years.” The guidelines also recommend education in CPR and the use of an AED for responders, such as police and firefighters.
Pacemakers Beneficial Even for Very Old Patients
From both a health and economic viewpoint, pacemakers seem to be beneficial for patients who are 80-plus years of age with severe slowing of the heart, German researchers report. Nowadays, about one-third of all pacemakers are placed in patients in this age group, the authors point out.
Although pacemakers are the treatment of choice for serious slow heart problems, the health benefits and cost-effectiveness of such therapy in very old patients has been unclear. To investigate, Dr. Manfred Zehender and colleagues from Universitatsklinikum Freiburg assessed the outcomes of 1,588 very elderly patients who received a pacemaker at their hospital between 1971 and 2000. Their findings, reported in the American Heart Journal, indicate that very old patients are now surviving longer with pacemakers. For example, in the 1990s, a person’s chances of being alive five years after pacemaker placement was 66 percent, significantly higher than the 37 and 47 percent odds seen in the 1970s and 1980s, respectively. Patients most likely to experience a survival benefit with pacemakers included women and those who received their device in the 1990s. Still, these factors should not be used to guide pacemaker selection, the authors emphasize.
Based on a life expectancy of about eight years for very elderly patients, the researchers estimate that the cost of treating slow heart symptoms with a pacemaker would be no more than $500 per patient annually. The findings indicate that “pacemaker therapy is a clinically and economically effective therapeutic option to control (slow heart) symptoms” in very elderly patients, the authors state.
In a related editorial, Dr. Arshad Jahangir and Dr. Win K. Shen, from the Mayo Clinic in Rochester, Minnesota, comment that while the new findings are “intriguing,” the study lacks a variety of data that would allow an adequate assessment of cost effectiveness. |
