A publication of Cardiology Associates â€˘ Mobile, Alabama
Volume 5 Number 1
Advances in implantable Cardiac Device Therapy By Robert A. VerNooy, MD, FACC
PVD: Screening, Therapy, and implications By J. McLean Trotter, M.D.
Heart Failure in the 21st Century By Kenneth Burnham, M.D., FACC 1
Spring 2009 As the practice of cardiology evolves we are continuously seeking ways to bring the most recent advancements and ongoing research to our patients. Staying on the leading edge of Mobile Gerry M. Phillips, M.D., FACC Kenneth E. Francez Jr., M.D., FACC J. Andrew Morrow Jr., M.D., FACC, FACP M. Wail Hashimi, M.D., FACC Richard J. Chernick, M.D., FACC Erik A. Eways, M.D., FACC Charles W. Parrott, M.D., FACC Kenneth M. Burnham, M.D., FACC Michael W. Monson, M.D. Jason H. Cole, M.D., MSc, FACC Glenn A. Cochran, M.D., FACC L. Daven Cave, M.D. Electrophysiology Stephanie D. Grosz, M.D., FACC D. Scott Kirby, M.D., FACC Robert A. VerNooy, M.D., FACC Pediatric Cardiology David C. Mayer, M.D., FACC, FAAP Lynn Arnold Batten, M.D., FACC, FAAP Cholesterol and Lipid Disorders Mary H. Honkanen, M.D. 6701 Airport Boulevard Suite D-330 Mobile, AL 36608 (251) 607-9797 Fax (251) 639-0940 1720 Springhill Avenue Suites 101 and 201 • Mobile, AL 36604 Adult (251) 438-4600 Fax (251) 433-7685 Pediatric (251) 434-9177 Fax (251) 432-1059 3715 Dauphin Street Suite 4400 • Mobile, AL 36608 (251) 46O-0078 Fax (251) 460-4676 Baldwin County Frank T. Bunch, M.D., FACC Brian D. Dearing, M.D., FACC David T. Trice, M.D., FACC James R. Stinebaugh Jr., M.D., FACC Karl V. Hakmiller, M.D., FACP, FACC Ralph S. Buckley, M.D., FACC J. McLean Trotter, M.D.
cardiology is as exciting as it is challenging. In this issue of Cardiology Currents, we hope to share with you information that you will fi nd not only interesting but somewhat enlightening. Dr. Ken Burnham has recently returned from the Heart Failure Society of America National Conference and shares the most up-to-date information on pharmacologic, diet and device therapies in the treatment in one of the most challenging and growing areas of cardiology, heart failure. In coupling with heart failure, Dr. Rob VerNooy, a cardiac electrophysiologist, brings light to the recent advances in cardiac device therapies using the perspective of how quickly and successfully this area of cardiology has changed and developed over the last 30 years. The practice of cardiology and the technologies now available in the 21st century are truly amazing. 64-slice CT Angiograpy (CTA) brings advancements that allow us to determine health or disease in small coronary and peripheral arteries without a catheter. Dr. Jason Cole, and our CT lab professionals bring to the Mobile area unprecedented experience in this area. With permission from the Journal of Computed Tomography, we are happy to share with you an editorial submitted by Dr. Cole regarding CTA and “asking the right questions.” The advancements and treatments in peripheral vascular disease have also benefitted greatly from the use of CTA. Dr. McLean Trotter, peripheral interventionalist, shares with you insight, screening and treatments in this area. With all the technology, medical advancements and changes in cardiology today it is important not to lose focus on the patient. At Cardiology Associates, we strive to treat the person, not just the symptoms, and ensure the health and well-being of every patient. Ever mindful of the fi nancial impact of cardiac care, we strive to provide the most comprehensive yet cost-effective treatment possible. We hope you enjoy this edition of Cardiology Currents and as always we are appreciative of the opportunity to participate in the cardiovascular care of your patients. Sincerely,
Electrophysiology James A. Storey, M.D., FACC 188 Hospital Drive Suite 100 • Fairhope, AL 36532 (251) 990-9500 Fax (251) 990-9501
Gerry Phillips, MD, FACC
1721 North McKenzie Street Foley, AL 36535 (251) 943-4100 Fax (251) 943-3794 www.cardassoc.com Terence E. Hale, M.D.,FACC (1955-2000) Vance M. Chunn, FACHE CEO/Administrator Editor Erik A. Eways, M.D., FACC Edition 12
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Mobile Heart Team
Gerry M. Phillips, M.D. interventional
Richard J. Chernick, M.D. invasive
Michael W. Monson, M.D. interventional/Peripheral
Kenneth E. Francez Jr., M.D. interventional
Erik A. Eways, M.D. interventional/Congenital Defects
Jason H. Cole, M.D. invasive/Preventive
J. Andrew Morrow Jr., M.D. interventional
Charles W. Parrott, M.D. interventional
Glenn A. Cochran, M.D. invasive
Stephanie D. Grosz, M.D.
D. Scott Kirby, M.D.
Kenneth M. Burnham, M.D. invasive/Heart Failure
L. Daven Cave, M.D. invasive
Cholesterol and Lipids
M. Wail Hashimi, M.D. interventional
Robert A. VerNooy, M.D.
Mary H. Honkanen, M.D.
Baldwin County Heart Team
Frank T. Bunch, M.D. interventional/Peripheral
Brian D. Dearing, M.D. interventional/Peripheral
David T. Trice, M.D. interventional
James R. Stinebaugh, Jr., M.D. invasive
Karl V. Hakmiller, M.D. invasive
Ralph S. Buckley, M.D. Clinical
J. McLean Trotter, M.D. interventional/Peripheral
James A. Storey, M.D.
6701 Airport Boulevard Suite D-330 Mobile, AL 36608 (251) 607-9797 Fax (251) 639-0940
188 Hospital Drive Suite 100 • Fairhope, AL 36532 (251) 990-9500 Fax (251) 990-9501
1720 Springhill Avenue Suite 101 • Mobile, AL 36604 Adult (251) 438-4600 Fax (251) 433-7685 Pediatric (251) 434-9177 Fax (251) 432-1059
1721 North McKenzie Street Foley, AL 36535 (251) 943-4100 Fax (251) 943-3794 Outreach Clinics BayMinette, Atmore, Chatom. Jackson, AL, & Lucedale, MS 800-842-4009
3715 Dauphin Street Suite 4400 • Mobile, AL 36608 (251) 46O-0078 Fax (251) 460-4676
David C. Mayer, M.D.
Lynn Arnold Batten, M.D.,
Advances in Implantable Cardiac Device Therapy by: Robert A. VerNooy, M.D., FACC
pacemakers and implantable cardioverter defibrillators (ICDs), continue to evolve and offer more diagnostic and therapeutic
Pacemakers and ICDs have gone
through dramatic advances since they were initially introduced as effective treatments. More recently, biventricular pacemakers and biventricular ICDs have been developed as effective tools in the management and treatment of congestive heart failure. Taking a look back is helpful to give us perspective on how far we have come.
In 1980, the fi rst
report of a successful ICD implant in humans was published. Interestingly, these fi rst ICD prototypes were built from over-the-counter electronics. The fi rst generation of medically approved ICDs were 5-10 times bigger by volume, were shock-only, nonprogrammable, had short life-spans, and required thoracotomy for epicardial lead placement and abdominal generator insertion. Technological improvements in the 1990s created programming options, smaller and longer lasting batteries
generators and transvenous leads. These advances made initial implant easier and safer and allowed
greater patient convenience with smaller sizes and improved battery and lead longevity.
Leads and generators became
more reliable, and longer lasting and enhanced features were added to include brady and anti-tachycardia pacing (ATP) and more overall programmability.
Shock waveforms were also
fi ne-tuned (e.g. biphasic rather than monophasic) to decrease energy requirements and improve the efficacy and reliability of defibrillation. Over this time, these advancements helped to treat arrhythmia-related bradycardia and tachycardia symptoms, improved efficacy of ICD therapies, minimized inappropriate device therapies, and thereby improved quality of life. Since the year 2000, the most notable major clinical advance was born in biventricular devices (a.k.a. Cardiac Resynchronization Therapy (CRT)). They were fi rst approved for use in the United States in 2002 and were developed
t A. V
to resynchronize ventricular activation as a treatment for congestive heart failure. When left ventricular ejection fraction is impaired with evidence of muscular dysfunction (LVEF <35 percent) and electrical conduction is delayed (QRS > 120 ms), cardiac muscular contraction can be “resynchronized” by pacing the left and right ventricles simultaneously, which improves overall cardiac output. Pacing the left ventricle is typically accomplished transvenously by adding an additional
“Implantable cardiac devices, specifically pacemakers and implantable cardioverter defibrillators (ICDs), continue to evolve and offer more diagnostic and therapeutic capabilities.”
left ventricular pacing electrode via the coronary sinus (CS) to wrap around the left lateral epicardial aspect of the left ventricle. The subset of congestive heart failure (CHF) patients currently indicated and proven to benefit from these types of devices are those with more advanced CHF symptoms, with New York Heart Association Class III or IV. Although BiV pacemakers are available for patients, the vast majority of these devices implanted in the U.S. are biventricular (BiV)-ICDs, since those patients indicated for biventricular pacing are also indicated for ICDs. Large-scale randomized clinical trials have shown not only a significant benefit in CHF morbidity, but also BiV pacing decreases mortality as well (CARE-HF Trial, NEJM 2005). Of note, this mortality benefit of BiV pacing is additive to the mortality benefit of ICDs. Over the last few years, there has been the development of improved therapeutic pacing algorithms to help manage atrial fibrillation and congestive heart failure.
atrial overdrive pacing algorithms in pacemakers and ICDs can help mildly decrease the incidence of atrial fibrillation (AFib) episodes and symptoms. Device storage capabilities
can track AFib burden and ventricular rates during AFib to better help clinicians decide on the appropriateness of anticoagulation and adjunctive additional rate or rhythm control therapies (medical or ablative). In dual chamber pacemakers and ICDs, pacing algorithms have also been developed which effectively minimize unnecessary (inappropriate) right ventricular (RV) apical pacing. Pacing studies have now clearly established that as RV ventricular pacing increases, so does the risk of developing CHF and AFib. Thus, advanced algorithms that pace in the RV only when absolutely necessary are now preferred. In biventricular devices for the treatment of CHF patients, newer adjunctive diagnostic and pacing capabilities also exist. Certain clinical parameters can be tracked, logged, and stored in these devices for clinician review to help in the management of CHF. Examples include: patient activity level, heart rate trends and variability, percent pacing, home blood pressure and weight (via accessory equipment), AFib burden, and ventricular rates during AFib. With biventricular devices, as opposed to single or dual chamber pacemakers with only a one-sided RV pacing wire, the goal is to BiV pace 100 percent to allow resynchronization of cardiac contraction as much as possible. These devices have specialized pacing algorithms to promote 100 percent BiV pacing. Optimal timing between atrial, right ventricular, and left ventricular pacing to best improve cardiac output can also be variable between patients and can change in a given patient over time as physiologic properties of their heart change. “Optimizing” of these pacing intervals can be done rather easily and in some devices in an automated fashion on interrogation (St. Jude Medical’s QuickOpt). These changes can clearly improve the clinical response of biventricular pacing over time in some patients. A newly developing direction in implanted cardiac devices is the potential to make other innovative physiological measurements that may correlate with CHF status (e.g. intracardiac or pulmonary artery pressures). These measurements may thereby be beneficial in the clinical management of CHF. One such measurement is already clinically available in some biventricular pacemakers and ICDs (Medtronic’s Optivol). It measures the daily thoracic impedance between the intracardiac electrodes and the pectoral generator through intervening lung and other tissues. As interstitial and pulmonary fluid increases in CHF, the measured impedance (electrical resistance) in patients trends downward. This is automatically indexed and tracked over time to help assess volume status in a given patient. Initial studies and clinical experience suggests that it is helpful to predict an acute
CHF exacerbation and may be another tool clinicians may use to recognize and treat CHF earlier to minimize symptoms and hospitalizations. Our CHF physicians at Cardiology Associates already have experienced its utility in patient management. Perhaps the most important advance in the last few years from a physician and patient’s perspective in the management and follow up of cardiac devices has been the advent of wireless communication and remote interrogation. All three major manufacturers of pacemakers and ICDs now offer wireless interrogation and programming of devices at implant or in clinic.
This speeds up in-person interrogation and
programming. Additionally, small, very easy to use, portable “home” remote communicators for all ICDs and currently some pacemakers can interrogate a patient’s device with complete stored data to be transmitted over phone lines to a Web site. This can be easily accessed and reviewed by Device Clinics for routine device follow up without a patient encounter. Also, it can be set up to automatically alert clinicians earlier to device related problems and can be utilized as needed for remote interrogation after a patient feels a worsening change
“Perhaps the most important advance in the last few years from a physician and patient’s perspective in the management and follow up of cardiac devices has been the advent of wireless communication and remote interrogation.”
in arrhythmia or CHF symptoms or after ICD shocks. Clearly, remote monitoring has added to patient convenience, costsaving, and compliance with follow up, and improved Device Clinic efficiency. Finally, it must be mentioned that there has been a good deal of negative press about device and lead malfunction with some advisories on certain models and “recalls.” What we have learned has created undo alarm about implantable devices, and even in these cases where potentially harmful problems were identified, the mechanical failure rate was still very low. In fact, follow up studies have shown in these particular advisory or “recalled” implantable device situations the risks of widespread explanting and changing out of these generators or leads led to more clinical risk and harm than the identified intrinsic failure rate of these “recalled” devices. Even with the ever improving progress and innovation of science and engineering, no man-made device will ever be perfect and will always have a certain failure rate. Minimizing that failure rate to acceptable levels must constantly be the goal for any medical device, while expanding its clinical benefits. Overall, implantable cardiac devices continue to maintain excellent reliability, and hopefully I have successfully illustrated how much they have continued to be refi ned over time to reduce arrhythmia related morbidity and mortality.
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Coronary Artery Disease Therapy
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Coronary Artery Disease Therapy: multiple applications including debulking saphenous vein grafts, total occlusions crossable by a guidewire, in-stent restenosis prior to brachytherapy, ostial lesions, long lesions, moderately calcified lesions and PTCA dilatation failures.
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Peripheral Vascular Disease: Screening, Therapy, and Implications Peripheral Vascular Disease a leg with a noticeable change in color (paleness or blue(PVD) continues to become ness) coupled with coolness or a decrease in temperature a more frequently recogniz- could indicate poor blood flow. able health problem. It repMore importantly, it is crucial to identify the causes resents all of the diseases and risk factors associated with PVD. Smoking is the that cause obstruction of single most important modifiable cause of peripheral large peripheral arteries, vascular disease. Smokers have up to a tenfold increase which can result from ath- in relative risk for PVD in a dose-related effect specific to erosclerosis, inflammatory the cellular changes in the endothelium which promote processes leading to stenosis, the development and progression of atherosclerosis. embolism, or thrombus for- Patients with diabetes mellitus are particularly susceptible mation. PVD causes either to PVD. Our diabetic population is a difficult population J. McLean Trotter, M.D. acute or chronic ischemia, to treat due to their overall plaque burden and healing and this is mostly manifested difficulties. This subset of patients account for up to 70 in the lower extremities. The prevalence of the disease is percent of nontraumatic amputations performed. It is dependent on age and the underlying atherosclerotic risk also important to note that similar to coronary atheroprofile of each individual patient. It is estimated that the sclerosis, hypertension and dyslipidemia have also been overall disease prevalence of PVD is in the range of 10 associated with the development and acceleration of percent, increasing to about 20 percent in persons older PVD. We as physicians and health care providers need than 70 years of age. to understand the modalities that To optimally manage patients will not only treat the progression with lower extremity PVD, whether and complications of PVD but will symptomatic or asymptomatic, it is reduce coronary and cerebrovascuimportant to understand the global lar events. vascular disease burden, the natuUpon suspicion of PVD, the first ral history of the disease process, its line and least invasive study is the impact on the patientâ€™s lifestyle, and ankle brachial index. the risk factors for an individual ABI is the ratio of the blood prespatient. Such knowledge is the key sure in either the dorsalis pedis or in reducing mortality and morbidthe posterior tibial pulse to the blood ity. The classification of peripheral pressure in the brachial artery. ABI vascular occlusive disease was first measurement is one of the most described by Dr. Rene Fontaine cost-effective methods in assessing in 1954. Stage 1 is mild pain on PVD of the lower extremity and walking or claudication. Stage 2 typically is done with a handheld is severe pain on walking shorter Doppler ultrasound device. This is distances. Stage 3 represents pain a noninvasive, fairly reproducible at rest, while stage 4 presents as and inexpensive test. A resting ABI critical limb ischemia with possible of less than 0.90 is usually associtissue loss. The symptoms of clauated with 50 percent or greater dication can be described as pain, angiographic arterial stenosis, with weakness, or cramping in muscles a reported sensitivity of 95 percent Two dimensional curved format CTA due to decreased blood flow. Also, and almost 100 percent specificity. image of lower extremity to rule out claudication
ABI Severity Chart Supine Normal Mild Moderate Severe
Resting ABI >1.0 0.8-0.9 0.4-0.8 <0.4
Post-exercise ABI >1.0 >0.4 >0.2 <0.2
Further testing can be performed if symptoms and physical exam findings warrant. The use of spiral computed tomographic angiography in assessing lower extremity PVD has 93 percent sensitivity and 96 percent specificity for detection of stenoses greater than 50 percent, with high accuracy when compared to digital subtraction angiography. For most patients, this can be done with approximately 100 to 150 cc of IV contrast, and more importantly, it is noninvasive. It also provides critical details with anatomy that can assist with revascularization options. Magnetic resonance angiography can also be employed to define anatomy without the iodinated contrast or ionizing radiation, but the test is not as readily available and is slower to perform. There are also limitations in patients with pacemakers, defibrillators, and in those with metal clips, stents, or prostheses. Despite recent advances in the noninvasive evaluation of lower extremity PVD, contrast angiography remains the gold standard. Contrast angiography remains the most readily used and most widely available imaging technique for patients with PVD of the lower extremity in Three dimensional CTA image indicating occlusion of midwhom revascularization is contemplated. SFA in patient presenting with complaints Therapy for PVD is multifaceted and includes smoking cessation, exercise therapy, medications and mechanical revascularization. Medication with aspirin, clopidogrel, and for post limb salvage. More importantly, less than 50 percent statins, which reduce clot formation and cholesterol levels, of all amputees achieve mobility, producing a three and five can help with disease progression and address other cardioyear survival rate of 50 percent and 40 percent respectively. vascular risks that the patient is likely to have. In addition, Therefore, we must remain diligent in treating the entire vasif mechanical revascularization is needed, there are several cular system in our patients so that in saving a leg, we can percutaneous options that are available. Balloons and stents possibly save a life. have proven their durability and continue to be utilized in the lower extremities. However, newer modalities are also used for certain patient subsets and lesions. These particular devices mostly involve Nuclear pharmaceuticals, the most advanced detection tools the debulking of lesions. Laser and in the cardiovascular industry. cutting atherectomy devices are now available to reduce plaque burden and Partnering with a provider who is on time and dependable is vital in impove deliverability of balloons and providing superior care. Cardiology Associates choose Triad, as their Nuclear stents when needed. Pharmacy because every dose needs to be perfect. It is important to recognize PVD Mobile Birmingham Dothan early in order to help prevent the cost Triad Isotopes, Mobile Birmingham Nuclear Pharmacy Triad Isotopes, Dothan this disease places on the health care 251-471-5445 205-297-0075 334-792-7212 system and on the lives of our patients. ÂŠ The annual cost of post amputation care phone 866-310-0086 â€˘ www.triadisotopes.com is approximately $49,000, versus $600 ÂŠ 2007 Triad Isotopes, Inc. all rights reserved
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ARTICLE IN PRESS Journal of Cardiovascular Computed Tomography (2008) - , - –-
Reprinted with permission of the Journal of Cardiovascular Computed Tomography Editorial
Coronary CT angiography: asking the right questions Coronary computed tomography angiography (CCTA) has had an incredibly rapid rise. Few medical technologies have developed widespread use so quickly, and the result has been debate over its proper use. In the midst of ongoing controversy, it is useful to remember that the evidence in support of CCTA also has a short history. The first multidetector CT scanners were used clinically in 2000, and there was a rapid evolution to 16- and then 64-slice scanning within 5 years. Now, there are dual-energy scanners, ever-increasing numbers of slices, new detector technologies, and a multitude of different scanning protocols. Critics—ranging from payers to some physicians to the news media—have challenged that proponents of CCTA merely focus on the stunning detail of its images without relying on science. The best-known challenge arose from the Centers for Medicare and Medicaid Studies (CMS) in late 2007. CMS threatened to effectively shut down CCTA for Medicare beneficiaries by overturning local coverage determinations in favor of a national policy that limited coverage to minimal investigational indications. The pointed argument from CMS was that few ‘‘outcomes 1 studies‘‘ supported the technology’s use. Such criticisms have some basis in fact but may well be overstated. Within 2 years after the introduction of CCTA into clinical practice, no fewer than a half dozen studies were released, all echoing a similar theme: when completed and interpreted in a systematic fashion, CCTA is an accurate test. Negative predictive value for lack of an obstructive coronary lesion is well more than 90% (in comparison to invasive angiography) for most patient populations.2 It seems as though confirmatory studies on the accuracy of CCTA are emerging on a monthly basis. There have now been multicenter studies that reached similar results.3,4 For most practitioners in the field—and indeed for a large percentage of cardiologists and radiologists in general—the technical answers are in. CCTA is an accurate test in comparison to invasive angiography. It does not have equivalent temporal and spatial resolution, but, as a noninvasive test, it has clear advantages and provides reliable data. The challenge is that merely being an accurate test is really not good enough. Most of the challenges to the
technology make an end run around the issue of accuracy. ‘‘Sure,’’ the argument goes, ‘‘in a research setting and for a carefully controlled patient population, a noninvasive angiogram is reasonably accurate compared with an invasive angiogram. But does it provide something of value? How should I use the test?’’ And, indeed, that is probably the right question today: What is the clinical niche for this marvelous technologic advance? In the associated article, Hines et 5alprovide one possible answer to this question. In looking at resource utilization after introduction of a 64-detector CT scanner for cardiac applications, the authors find that there was a 21% absolute reduction in the rate of referral to invasive angiography, with no significant change in percentage of patients undergoing revascularization. The logical conclusion is that CCTA was an effective gatekeeper to the catheterization laboratory, eliminating unneeded invasive procedures without missing patients who would benefit from revascularization. This article is an important scientific contribution for a number of reasons. First, the setting is a large group practice. One of the biggest challenges with the application of medical literature from controlled trials is that patient populations and clinical settings are so carefully selected that it is difficult to generalize the results. In addition, the authors’ choice of clinical scenario, the mildly abnormal myocardial perfusion stress test, is an important clinical case. It seems quite authentic to the practitioner in the trenches who has to deal with this scenario every single day. In addition, it has been recognized as likely appropriate by consensus statement (although without rigorous 6 Finally, the authors do a nice job supporting evidence). of identifying the real effect of the technology by a comparison with matched patients before and after the introduction of CCTA. The strengths of this analysis do not remove certain challenges. One obvious concern is whether the authors’ endpoint, invasive coronary angiography, is indeed the most appropriate point of analysis. To some extent, angiography, and to a greater extent, percutaneous coronary intervention, are self-generating studies. The fact that revascularization was performed does not by itself mean that it was a necessary procedure. In the current environment, it could
1934-5925/$ -see front matter 2008 Society of Cardiovascular Computed Tomography. All rights reserved. doi:10.1016/j.jcct.2008.10.002
ARTICLE IN PRESS Journal of Cardiovascular Computed Tomography, Vol - , No - , - / be argued that a clinical model whereby single vessel coronary disease is identified by CCTA and then medical management used would make CCTA a far more attractive option. Perhaps CT angiography could not just substitute for invasive angiography when the former test was ‘‘negative’’ but could also substitute with a wider range of abnormal results. CCTA can give information that myocardial perfusion imaging cannot—whether or not atherosclerosis is present—and by implication how aggressive medical management should be. Ultimately, however, the only way to prove any of these possibilities would be to have a harder endpoint—myocardial infarction, hospitalization, or even mortality. In addition, radiation exposure is both a real and perceived challenge for all x-ray–based studies. One of the positive effects of debate over CCTA is that it has brought radiation exposure to the forefront of discussion, and physicians who might not have thought carefully about radiation exposure for a myocardial perfusion study now consider doses for both tests. However, any clinical algorithm that potentially exposes some patients to three consecutive tests with radiation will be under close observation. The authors of this study do not describe their radiation limiting protocols, but it is now known that a multitude of CCTA adjustments—including changes to kilovoltage and milliamperage, as well as decreasing anatomic field of view and using prospective electrocardiographic triggering as opposed to retrospective gating— may all become particularly important when multiple 7–9 radiation-based tests are layered on each other. Finally, the issue of costs has to be addressed. Although CMS officially states that costs are not considered in their evaluation of technology, there is no question that cost is at the top of a list of concerns for private payers. Indeed, the General Accounting Office has placed office-based imaging arrangements, presumably like the setup for the practice in this study, in the crossfire for cost containment. It is notable, however, that the clinical use described in this article is similar to a previous report that showed significant 10 cost savings for CCTA. Note that many of the challenges seen here cannot be avoided when looking at a retrospective database-driven study. One strength of the analysis—‘‘real-world data’’— also can be a detracting factor because it is not possible to control for all variables. That is one reason why it is a combination of the randomized control trial and observational studies that provides a complete analysis of any given technology. In addition, the challenge for harder endpoints is that sample size will have to be enormous to establish a statistically significant benefit in a population with low-tointermediate risk such as the one described. The most encouraging aspect of this discussion is that the right questions are now being asked. Undoubtedly, in the infancy of CCTA the studies had to be technical to prove accuracy. Now, however, it is even more appropriate that the questions come out of clinical practice. CMS was
right to point out the need for ‘‘outcomes analysis,’’ but manuscripts such as the current one would argue that the organization was even more right to leave local coverage decisions in place. To determine appropriate clinical niches for this technology, CCTA needs to be available in as many different settings as possible—not just the academic medical center or giant clinical practice with imaging subspecialists—but also the community hospital with well-trained practitioners to order and interpret the studies. 5 that multicenter prospective I agree with Hines et al studies are essential to further define how this test should be used. However, it is important that the studies be well designed. Crucial domains of study include CCTA as an initial diagnostic test compared with stress testing as well as its use as a layered test. Selection of study endpoints is also critical. The appropriate comparison can no longer be invasive coronary angiography, and we must no longer merely accept coronary revascularization as a sole or primary endpoint. Randomized trials are essential, but these must be furthered through large registry databases that require the support of the government, other payers, and vendors to be successful. Individual practitioners need to shoulder some of the responsibility for participating in these databases, and efforts must be made to make the burden of participation as low as possible. Ultimately, as data on the full range of relevant clinical outcomes starts to catch up with technical aspects of success, CCTA will become a mainstream test, with well-defined, evidence-driven applications for multiple clinical scenarios. Jason H. Cole, MD, MS, FACC Cardiology Associates of Mobile 3715 Dauphin Street, Suite 4400 Mobile, AL 36608, USA
References 1. Centers for Medicare and Medicaid Studies: Decision memo for computed tomography angiography (CAG-00385N). March 12, 2008. Available at: www.cms.hhs.gov/mcd/viewdecisionmemo.asp? ½ Q1 from25 viewdecisionmemo.asp&;id 5 206&. Accessed. 2. Raff GL: Interpreting the evidence: how accurate is coronary computed tomography angiography? J Cardiovasc Comput Tomogr. 2007;1:73–7. 3. Miller JM, Rochitte CE, Dewey M, et al: Coronary artery evaluation using 64-row multidetector computed tomography angiography (CORE-64): results of a multicenter, international trial to assess diagnostic accuracy compared with conventional coronary angiography ½ Q2 [abstract]. Circulation. 2007;116:2627–33. 4. Min JK, Budoff MJ, Dowe D, et al: The Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography (ACCURACY) trial. Late breaking ½ Q3 trials: Radiological Society of North America (RSNA). 2007. 5. Hines JL, Danciu SC, Shah M, Borg MJ, Biga C: Use of multidetector computed tomography after mildly abnormal myocardial perfusion stress testing in a large single-specialty cardiology practice. J Cardiovasc Comput Tomogr. 2008;2:XX–XX.
ARTICLE IN PRESS Cole
Coronary CT angiography
Cardiac Imaging; Society for Cardiovascular Angiography and InGillam LD, Hodgson JM, Kim RJ, Lesser JR, Martin ET, terventions; Society of Interventional Radiology. J Am Coll Cardiol. Messer JV, Redberg REF, Rubin GD, Rumsfeld JS, Taylor AJ, 2006;48:1475–97. Weigold WG, Woodward PK, Brindis RG, Douglas PS, 7. Husmann L, Valenta I, Gaemperli O, Adda O, Treyer V, Wyss CA, Peterson ED, Wolk MJ, Allen JM: American College of Cardiology Veit-Haibach P, Tatsugami F, von Schulthess GK, Kaufmann PA: FeaFoundation Quality Strategic Directions Committee Appropriateness sibility of low-dose coronary CT angiography: first experience with Criteria Working Group; American College of Radiology; Society prospective ECG-gating. Eur Heart J. 2008;29:191–7. of Cardiovascular Computed Tomography; Society for Cardiovascu8. Sigal-Cinqualbre AB, Hennequin R, Abada HT, Chen X, Paul JF: lar Magnetic Resonance; American Society for Nuclear Cardiology; Low-kilovoltage multi-detector row chest CT in adults: feasibility North American Society for Cardiac Imaging; Society for Cardioand effect on image quality and iodine dose. Radiology. 2004;231: vascular Angiography and Interventions; Society of Interventional 169–74. Radiology: ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 9. Stolzmann P, Leschka S, Scheffel H, Krauss T, Desbiolles L, Plass A, 2006 appropriateness criteria for cardiac computed tomography Genoni M, Flohr TG, Wildermuth S, Marincek B, Alkadhi H: Dualand cardiac magnetic resonance imaging: a report of the American source CT in step-and-shoot mode: noninvasive coronary angiography College of Cardiology Foundation Quality Strategic Directions with low radiation dose. Radiology. 2008;249:71–80. Committee Appropriateness Criteria Working Group; American Col- 10. Cole JH, Chunn VM, Morrow JA, Buckley RS, Phillips GM: Cost imlege of Radiology; Society of Cardiovascular Computed Tomograplications of initial CT angiography as opposed to catheterization in phy; Society for Cardiovascular Magnetic Resonance; American patients with mildly abnormal/equivocal stress tests. J Cardiovasc Society for Nuclear Cardiology; North American Society for Comput Tomogr. 2007;1:21–6.
Heart Failure in the 21st Century Kenneth M. Burnham, M.D., FACC
most recent ACC/AHA guidelines were updated in 2005 and the Heart Failure Society of America (HFSA) in 2006. What changes have occurred since these guidelines were published? With respect to medical management of chronic systolic HF, very little has changed. Recent trials have consistently demonstrated that compared with “standard of care,” newer outpatient therapies have not significantly reduced either HF hospitalization rates or cardiovascular mortality. However, upon closer inspection, “standard of care” in clinical trials does NOT reflect routine “community” care. That is to say where the control groups in clinical trails exhibit high uptake of standard therapies, the “real” world is different. Often patients are under dosed on life saving theraCongestive heart failure remains one of the pies. Although we generally understand most challenging areas of cardiology with the that-blockers should be titrated to target burden on individuals and society continuing doses (bisoprolol 10 mg daily, carvedilol to grow. 25 mg BID, or metoprolol XL 200 mg daily), we often fail to push vasodilator therapies (ACEI, ARB, hydralazine/ nitrates). It is the vasodilator therapy that on top of a stable background of-blocker and judicious diuretics reduces HF hospitalizations and improves patient “CHF.” These patients have many comorbid diseases perceived wellness. which either directly or due to therapies prescribed for Patients often state they have no symptoms, are not their treatment (e.g. NSAIDs for arthritis) impact ad- fatigued and yet, are not able to walk comfortably versely on their HF and precipitate decompensation. from the waiting room to the examination room or The majority of HF care is provided by the patient’s climb one fl ight of stairs. They have adopted a lowprimary care physician. Others are cared for by gen- er level of performance and are perceived as NYHA eral cardiologists and only a small percentage referred functional class I or II, when in truth they are class III to HF specialists in conjunction with specialty HF (symptomatic with routine modest activity). When clinics. Standards of care and metrics/guidelines have evaluating patients in the outpatient clinic, it isn’t been developed to assist in disease management. The enough to ask,“are you short of breath?” or “are you ongestive heart failure remains one of the most challenging areas of cardiology with the burden on individuals and society continuing to grow. There are well over five million Americans with CHF, and as our population ages, the numbers continue to rise, as do costs of care – the majority (> 40 percent) related to acute hospitalizations. This change in patient demographics is associated with an increasing prevalence of heart failure with preserved systolic function, a.k.a. diastolic HF approaching 50 percent of all patients admitted with
tired /fatigued?” We must ask, “what does it take make class III and IV, while ICD therapy is NOT generally inyou tired or short of breath?” or “what is the most active dicated in persistent class IV – defibrillation therapy has thing you are doing?” The level of symptoms (and NYHA not reduced cardiac mortality in these very ill individuals functional status) is important because our therapies are who often succumb to pump failure. recommended for certain “levels” of disease, e.g. aldosCurrently, application of proven pharmacologic and terone antagonists indicated for class III/IV. It is also device therapies has and will continue to make significant important to query patients regarding over the counter improvements in cardiovascular morbidity and mortalmedications and “neutriceutical” use, as these may have ity. Newer therapeutic strategies when added to “ideal” a significant negative impact on their HF symptoms. For conventional therapy will continue to have a difficult example, NSAIDs for arthritic aches or gouty symptoms task to demonstrate superiority. This is particularly true related to diuretics, hawthorn – proven to cause clinical of chronic, systolic heart failure. Newer treatments for deterioration in HF - or decongestants which may worsen acute heart failure, e.g. adenosine antagonists and natriarrhythmias or adversely affect volume status, should, in uretic peptides, are being evaluated, and early trial results general, be avoided. Similarly, any decrease in a patient’s are promising. Recent clinical trial inabilities to improve chronic heart failure therapies should be accompanied by outcomes in patients with preserved systolic heart failure, a clear statement of why and potential side effects of such the fastest growing population of persons with heart failreduction. In most cases, reductions in blockers or vasodilator therapies should be considered transient and other causes for patient’s symptoms (the most common cause for dose reduction) sought. In addition to pharmacologic therapies for heart fail- Heart failure device therapies have made signiﬁcant ure, there are a number of oth- improvements in patient’s quality and quantity of er therapies that are extremely life. The recent American Heart Association/ Heart important. Prescription of a Rhythm Society recommendations emphasize low sodium (generally 2,000 appropriate patient selection as well as providing mg) diet and appropriate fluid latitude where the science simply hasn’t yet been restriction cannot be over em- developed. phasized. It isn’t enough to say it; you need to empower the patient by providing dietary information, recipes and in certain cases, samples in your clinics. Although, not perfect, daily weights on a digital scale with read-outs ure, have caused clinicians and scientists to go “back to large enough to be seen by the patient can be an excellent the drawing board” – indicating a need for a paradigm low-tech way to allow patients a flexible diuretic regimen. shift in a disease that may be more a disease of the periphExercise/aerobic reconditioning with moderate, symptom- eral vasculature than the myocardium. Device therapy limited activity has been proven to have a significant im- will likewise see the limits pushed with indications for pact on the heart failure patient’s well-being and general CRT in class I and II likely to come, suggesting that corhealth (though not associated with reductions in death or rection of mechanical dyssynchrony slows down the rate hospitalization). of progression of systolic heart failure. Devices currently Heart failure device therapies have made significant available and newer technologies are being evaluated to improvements in patient’s quality and quantity of life. monitor fluid/volume or intravascular pressures to allow The recent American Heart Association/Heart Rhythm timely treatment of decompensation PRIOR to deterioSociety recommendations emphasize appropriate patient ration requiring hospitalization. Evaluations of cardiac selection as well as providing latitude where the science replacement therapies, stem cell strategies and ventricular simply hasn’t yet been developed. Although there was assist device micronization, and other surgical techniques initial concern that applying these guidelines to provide are also ongoing. defibrillation (ICD) and cardiac resynchronization (Bi-V) For now, our concern must remain with our patients therapies would “break the bank,” the uptake and applica- who continue to struggle to live, to breathe, to pursue life tion of these therapies to appropriate candidates remains rather than merely exist as cardiac cripples. Application at 50 percent and 35 percent, respectively. It is important of guideline-directed therapies are critical to practitioto note, as with pharmacologic treatments, there are some ners caring for these patients. For patients whose disease restrictions to consider: patients for ICD should be on continues to progress or who are refractory to prescribed optimal medical therapy and have a live expectancy of therapies, referral to specialty heart failure programs are at least one year with (in general) a LVEF <= 35 percent. particularly appropriate. Resynchronization therapy has been validated in NYHA
Time is not on your side
when you’re having a heart attack –but we are.
Symptoms as subtle as chest pains could mean something as serious as a heart attack.That’s why it’s important to seek immediate care from a place where the physicians and staff can give you the care you need. A place like South Baldwin Regional Medical Center. South Baldwin is proud to be among the 173 hospitals recognized by the American Heart Association in U.S. News and World Report for improving the quality of care in coronary artery disease patients through one innovative program: Get With the Guidelines. South Baldwin Regional Medical Center. The cardiac care you need. Right here. Right now.
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For more than 20 years, we’ve put our heart into keeping yours healthy. After experiencing chest pains, Tom was understandably anxious about the possibility of heart disease. The doctors at Cardiology Associates, using the very latest, non-invasive cardiac CT technology, were able to take a complete look at his heart in a matter of seconds. Much to his relief, no problems were found. As Tom will tell you, it’s a story with a very happy ending. For Cardiology Associates, it’s another chapter in our legacy of caring that includes the most comprehensive cardiovascular care in the area.
251.607.9797 | 800.842.4009 | www.cardassoc.com | Drs. Phillips, Francez, Morrow, Hashimi, Grosz, Chernick, Dearing, Eways, Parrott, Burnham, Kirby, Trice, Stinebaugh, Monson, Hakmiller, Buckley, Cole, Cochran, Storey, Cave, Mayer, Trotter, Hackman, VerNooy, Batten and Honkanen. 1200-MCD87 MobBayMonthly.indd 1
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