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From the publishers of The New England Journal of Medicine
CA RDI OLOGY
Improvement in U.S. Heart Failure Outcomes, 1998–2008
Hospitalizations declined by 30%, and 1-year mortality declined by 7%.
The past decade has witnessed improved prevention, recognition, and treatment of ischemic heart disease, an important cause of heart failure (HF). However, the U.S. population is aging, which might increase HF prevalence. These investigators assessed trends in hospitalization for HF and associated mortality between 1998 and 2008 in the U.S. Medicare feefor-service population. Over 10 years, hospitalizations for HF fell by 29.5% (from 2854 to 2007 per 100,000 person-years) after adjustment for age, sex, and race. Mean duration of hospital stay also declined, from 6.8 days to 6.4 days. Reductions in hospitalization were significant in all race and sex subgroups, although it was smallest in black men, who had an unadjusted decline of only 22.7% (from 4142 to 3201 per 100,000 personyears). Overall risk-adjusted 1-year mortality declined from 31.7% to 29.6%. At the state level, admission and mortality trends
were heterogeneous: The decline in hospitalization rate was significantly greater than the national average in 16 states and significantly less in 3, and 1-year mortality increased significantly in 5 states and decreased significantly in only 4.
Chen J et al. National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998-2008. JAMA 2011 Oct 19; 306:1669.
These substantial declines in hospitalization for heart failure are encouraging. Mortality has also improved, although much less than hospitalization, and the improvements have not benefited all races and sexes equally. The exact reasons for these trends — which may include lower HF incidence, better delivery of evidence-based therapy, or the development of new treatment strategies — remain to be determined. Furthermore, overall HF mortality remains high, and progress has not been geographically uniform, suggesting that, despite the good news this study brings, we have much more work to do to improve HF outcomes. — Frederick A. Masoudi, MD,
MSPH, FACC, FAHA
Journal Watch Cardiology Editor-in-Chief Harlan M. Krumholz, MD, SM, is a coauthor of the summarized article but had no role in its selection or review.
Asymptomatic Bradycardia Does Not Predict Mortality in Older Adults
In a single-center cohort, untreated bradycardia in adults older than 60 was associated with eventual pacemaker placement but did not increase mortality risk.
The prognostic implications of asymptomatic bradycardia in older patients are unclear. To correlate asymptomatic bradycardia with associated electrocardiographic findings and outcomes in this population, investigators at a single institution examined all electrocardiograms obtained in outpatients aged >60 during 1990–1995. The researchers compared the clinical need for pacemaker implantation and mortality in patients with asymptomatic bradycardia (heart rates <55 beats/minute without pacemaker implantation during the subsequent 2 weeks) and in those with normal heart rates (60–70 beats/minute). Of 2560 patients, 470 had asymptomatic bradycardia. During a mean of 7.2 years of follow-up, patients with asymptomatic bradycardia had significantly higher rates of pacemaker implantation than those without bradycardia; however, the difference did not emerge until after approximately 4 years, and the annualized rate of pacemaker implantation in the asymptomatic bradycardia group was <1% per year. In multivariate analysis of heart rate as a continuous rather than a binary variable, increasing bradycardia remained a significant predictor of pacemaker implantation. The presence of atrial fibrillation and longer PR and QRS intervals were each also strongly associated with pacemaker implantation. Kaplan-Meier curves for the
SUMMARY & COMMENT
Improvement in U.S. Heart Failure Outcomes, 1998–2008 ................................................................... 89 Asymptomatic Bradycardia Does Not Predict Mortality in Older Adults ......................................... 89 MRI Studies Can Be Performed Safely in Patients with Implantable Cardiac Devices ... 90 Use Caution to Prevent Infection When Implanting Pacemakers or Deﬁbrillators............. 90 Which Patients Respond to Cardiac Resynchronization Therapy?.............. 91 Carotid Artery Stenting in the Real World .............. 91 Is Same-Day Discharge Safe After Percutaneous Coronary Intervention? ...... 92 Care Transitions Pose High Risk for Medication Errors .............................................. 92
Time in Therapeutic Range for Warfarin — A European Success Story..................................... 92 Combining FAME and SYNTAX in a Functional Score Improves Risk Assessment ..............94 Bioresorbable Stent Ready for Randomized Evaluation ..................................... 94 Xanthelasma, but Not Arcus Senilis, Predicts Atherosclerotic Vascular Disease and Death .... 95 Omecamtiv Shows Early Promise for Heart Failure ........................................................ 95 Quality of Life Improves After Transcatheter Aortic Valve Implantation............. 96
CLINICAL PRACTICE GUIDELINE WATCH
Focused Update: ACC/AHA Guidelines on Peripheral Arterial Disease .............................. 93
JOURNAL WATCH (AND ITS DESIGN) IS A REGISTERED TRADEMARK OF THE MASSACHUSETTS MEDICAL SOCIETY. AN EDITORIALLY INDEPENDENT LITERATURE-SURVEILLANCE NEWSLETTER SUMMARIZING ARTICLES FROM MAJOR MEDICAL JOURNALS. ©2011 MASSACHUSETTS MEDICAL SOCIETY. ALL RIGHTS RESERVED. DISCLOSURE INFORMATION ABOUT OUR AUTHORS CAN BE FOUND AT http://cardiology.jwatch.org/misc/board_disclosures.dtl
Ontario.). Director. To estimate the cost of devicerelated infections infected devices to individuals and society. University of Bern. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. The Ohio State University Heart Center. Professor of Medicine. Boston Frederick A. New Haven EXECUTIVE EDITOR Kristin L. Am J Cardiol 2011 Sep 15. Matthew O’Rourke.O. lead impedance) in the study group. vices. MD. Cardiovascular Wellness Center. Robert Dall. Lindenhofspital. Journal Watch General Medicine Nazarian S et al. Link. William Paige. Bette Clancy. investigators evaluated whether MRI studies could be performed safely at the commonly used magnetic strength of 1. Switzerland CONTRIBUTING EDITORS William T. Sharon S.. Gore. MPH. these results should not be extrapolated to MRI scanners with field strengths lower or higher than 1. Salinger. Chief. US$80 (Intl). placement of devices in sicker patients. M4Y 3A5. Publisher Betty Barrer. MD. Boston Joel M. E-mail inquiries or comments via the Contact Us page at JWatch. MD. Columbus Hugh Calkins. MD. Division of Cardiology. Martin Jukovsky. COMMENT Use Caution to Prevent Infection When Implanting Pacemakers or Defibrillators An analysis of a Medicare database shows that device-related infections not only increase mortality but also cost the healthcare system a lot of money. 438 patients with pacemakers (54%) or implantable cardioverterdefibrillators (ICDs. FACP.71 (Canada). Patients with infection during admission were significantly more likely than those without infection to die during the admission quarter or the following four quarters. C$265. Jr.S. 108:857. MD. Fitzpatrick. Vice President for Publishing. sensing.). Advertising Sales. Box 9100. Lew Wetzel. Art Wilschek. these changes did not require device revision or reprogramming. C$96. Denver Beat J.). 17 No. Gore. 12 two groups showed no significant difference in overall survival.g. MRI Studies Can Be Performed Safely in Patients with Implantable Cardiac Devices Patients were monitored carefully during magnetic resonance imaging procedures and had no apparent problems. center and one Israeli center. US$240 (Intl).org/misc/conflict.” However. Editorial Director. New England Medical Center and Tufts University School of Medicine. Director.5 T in patients with implantable cardiac devices who had clinical indications for MRI. accounted for most of the costs.dtl CARDIOLOGY Vol. Masoudi. Editorial and Product Development.g. Staff Editors. MD. Postal Station F. Professor of Medicine. The mean adjusted total cost of a single admission with infection ranged from $28.and long-term changes in device function were observed (e. Hines. Chief. Reynolds MR and Zimetbaum P.9% of cardiac-device admissions involved an infection.S. investigators analyzed Medicare data for 200. P. Although minor short. and oximetry were monitored by experienced clinicians.O. US$165 (Intl). Customer Service Published 12 times a year. In three patients (0. Section of Cardiovascular Medicine. The protocol involved changing pacing mode as indicated and disabling tachyarrhythmia functions.). Edward Budnitz Professor of Cardiovascular Medicine. probably because of expanding indications. Ann Arbor MASSACHUSETTS MEDICAL SOCIETY Christopher R. 155:470. FAHA Associate Professor of Medicine. Odmark Massachusetts Medical Society DEPUTY EDITOR Howard C. Institutions: $225 (U. and a broadening cadre of implanting physicians and facilities. Interventional Cardiology and Cardiac Catheterization Laboratories. In all. However.org. All others remit to: Journal Watch Cardiology. the FDA recently approved a pacemaker designed to function safely in the MRI environment under certain conditions (e. individual print only: $89 (U. Meyer. SM. MD.67 (Canada). Subscription rates per year: $119 (U. Eagle. The Johns Hopkins Hospital. P. Yale University School of Medicine. none of these patients experienced long-term device dysfunction. Residents/Students/Nurses/PAs: $69 (U. Director. HST. Ann Intern Med 2011 Oct 4. we should consider alerting these individuals to their potential future need for a pacemaker. Toronto. including replacement devices. The rate of infection associated with implantable cardiac devices (pacemakers or defibrillators) is increasing. symptoms. Information on our conflict-of-interest policy can be found at JWatch. Significance of asymptomatic bradycardia for subsequent pacemaker implantation and mortality in patients >60 years of age. Bern. Harold H. Overall.S.7%). Prices do not include GST. blood pressure. Division of Cardiology. Magnetic resonance imaging and cardiac devices: How safe is safe enough? Ann Intern Med 2011 Oct 4. Herrmann. MD. MA 02454-9085 or call 1-800-843-6356. Baltimore FOUNDING EDITOR Kim A. replacement. In this prospective study conducted at one U. Krumholz. Christine Sadlowski. Misty Horten. 46%) who underwent 555 MRI studies participated. implanted devices reverted to a backup mode that allows the devices to function after loss of programmable memory. University of Pennsylvania Medical Center. Layout. Worcester Mark S.90 EDITOR-IN-CHIEF Harlan M. 155:415. COMMENT In this study. 2.676 to $53. MD. MD.5 T. MD Goldberger JJ et al. Foody. Lynch. MD. or VAT. Division of Cardiology. Division of Cardiovascular Medicine. University of Massachusetts. University of Colorado. Notably. electrocardiography. MSPH.S. In Canada remit to: Massachusetts Medical Society C/O #B9162. University of Michigan Medical Center. COMMENT Patients older than 60 with asymptomatic bradycardia can be reassured that their long-term prognosis is no different from that of patients without asymptomatic bradycardia. Waltham. Magnetic resonance imaging (MRI) studies usually are avoided in patients with implantable cardiac devices because of safety concerns.349. Albion Walter Hewlett Professor of Internal Medicine and Chief of Clinical Cardiology. Philadelphia ASSOCIATE EDITORS JoAnne M. Professor of Medicine and Director of Electrophysiology.219 hospital admissions during 2007 that included a fee-forservice pacemaker or defibrillator implantation. FACC. Publishing Services.19 (Canada). Christine Miller. — Joel M. — Paul S. Abraham.S. Associate Professor of Cardiology. Brigham and Women’s Hospital. Professor of Medicine. Associate Professor of Medicine. Editorialists suggest that the presence of an implantable cardiac device “should no longer be considered an absolute contraindication to MRI. or revision procedure. half of the incremental mortality occurred after hospital discharge. Box 9085. Mueller. MRI procedures were performed safely using a defined protocol in patients who had implantable cardiac de- That cardiac implantable device–related infections are costly and associated with ... at defined MRI magnet strength). Copy Editor. C$166. Alberta L. intensive care and supplies.
however. To see whether operator experience similarly affects outcomes of CAS. Of 31 patient factors considered in the current analysis. Approximately 25.2011. 77. JAMA 2011 Sep 28. Carotid stenting at the crossroads: Practice makes perfect. [e-pub ahead of print].2011. according to a regression model. 306:1338. and LV ejection fractions ≤30% were randomized to receive an implantable cardioverterdefibrillator either with or without CRT. Journal Watch Neurology Journal Watch Cardiology Editor-in-Chief Harlan M. 1820 patients with mild heart failure (HF). MD. the predictive value of this particular combination of factors must be validated prospectively before clinicians use the information to care for patients.org 91 higher mortality is no surprise. 306:1378. Score 3 2 2 2 2 2 1 Along with many studies linking higher procedural volume to better outcomes in other fields. half in asymptomatic patients. However.org/10. compared with about 1% in randomized trials. which were assigned according to each factor’s contribution to the echocardiographic benefit. the primary composite endpoint of death or acute congestive HF was significantly lower in the CRT group than in the non-CRT group (JW Cardiol Oct 2009. High-volume providers (≥24 procedures per year) were significantly more likely to operate on patients with asymptomatic carotid stenosis. and female sex have previously been shown to predict response to CRT. (http://dx. — Hooman Kamel. Circulation 2011 Oct 4. adherence to current guidelines for patient selection and infection prevention in device implantation is crucial. p. Left bundle-branch block. QRS Factors Associated with Favorable Response to Cardiac Resynchronization Therapy Factor baseline left-atrial volume <40 mL/m baseline left ventricular enddiastolic volume ≥125 mL/m2 nonischemic origin of cardiomyopathy QRS duration ≥150 milliseconds left bundle-branch block female sex prior heart failure hospitalization 2 These 7 characteristics may offer some guidance as to which patients benefit from cardiac resynchronization therapy. As an editorialist notes. .1001/archinternmed. This observation highlights the need for accurate risk stratification of asymptomatic carotid stenosis and for studies comparing aggressive medical therapy with carotid revascularization in asymptomatic patients. MD Goldenberg I et al.446) durations ≥130 milliseconds. but some may be practicing too much (and not enough). Thirty-day mortality in patients treated by very low-volume providers (<6 procedures per year) was almost double that in patients treated by high-volume providers. knowing how many dollars and lives could be saved by a sharper focus on prevention should motivate policy makers to act.441) Margey R. To inform the debate about what factors predict an echocardiographically measured response to CRT. (http://dx. JAMA 2011 Sep 28. Arch Intern Med 2011 Sep 12. In nearly every trial of cardiac resynchronization therapy (CRT). COMMENT Which Patients Respond to Cardiac Resynchronization Therapy? A score of at least 5 on a 14-point scale comprising 7 patient factors was a significant predictor of reverse remodeling among CRT recipients in the MADIT-CRT trial. symptoms.doi . However. Mortality and cost associated with cardiovascular implantable electronic device infections. MD Sohail MR et al. although their comparability remains controversial. and other potential confounders. investi- Nallamothu BK et al. only about two thirds of CRT recipients benefitted from the therapy. Cardiac implantable electronic devices: Pacing our enthusiasm. Krumholz. COMMENT gators examined Medicare data on CAS from 2005 through 2007. very wide QRS durations. 361:1329). — Mark S. Patients treated earlier in an operator’s career also had higher mortality than those treated later in an operator’s career. MD. is a coauthor of the summarized article but had no role in its selection or review. In the MADIT-CRT trial.December 2011 JWatch. The table lists the 7 factors and their corresponding scores. Link. Overall. 124:1527. CEA must be performed by experienced surgeons with low complication rates to provide a benefit over medical management. an accompanying editorial justifiably calls for referral of patients with carotid stenosis to neurologists for a balanced discussion of the risks and benefits of various treatment options before carotid revascularization is undertaken. Successful prevention programs will include systematic consideration of patient comorbidities and proper training of both physicians and hospital staff. Carotid Artery Stenting in the Real World An analysis of operator experience and outcomes raises questions about who should perform carotid artery stenting. Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA) for reducing the risk for stroke from carotid stenosis. and who should undergo it. [e-pub ahead of print].1001/ archinternmed. researchers analyzed data from the 1761 patients in the MADIT-CRT trial who had complete echocardiographic information. Patients with a total score ≤4 (out of a possible 14) showed no significant benefit from CRT.org/10. Operator experience and carotid stenting outcomes in Medicare beneficiaries. The overall 30-day mortality after CAS was nearly 2%.doi. these findings reinforce the need to establish rigorous training standards and systems for referral to experienced CAS proceduralists. the high proportion of CAS-treated patients with asymptomatic disease and the high overall mortality in this study also raise the question of whether CAS is being used appropriately in relation to medical therapy. Arch Intern Med 2011 Sep 12. SM. What this substudy adds to existing evidence is the finding that no single factor is enough to predict benefit. 7 were associated with reverse remodeling in the CRT group. even after adjustments for comorbidity. Predictors of response to cardiac resynchronization therapy in the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT). In the meantime.000 CAS procedures were performed on Medicare beneficiaries. Halm EA. — Mark S. and N Engl J Med 2009. Link.
These investigators analyzed registry data from 2008 on 18. 17 No. With an expanded target INR of 1. and heart valve dysfunction (13%). Vol. Mean warfarin dose fell with increasing age from 43 mg/week in continued on page 94 This observational study provides a bird’s eye view of what we already know well — . researchers retrospectively evaluated Canadian administrative databases that contained information about 190. the Swedish national quality registry for atrial fibrillation (AF) and anticoagulation was founded in 2006. Prevalence and outcomes of same-day discharge after elective percutaneous coronary intervention among older patients. 4. Care Transitions Pose High Risk for Medication Errors An observational study reveals that many hospitalized patients have their longstanding medications inadvertently discontinued on discharge. the adjusted mean TTR was 76. MD In studies of warfarin. 50%). venous thrombosis (19%).25% of patients were discharged on the same day as the procedure raises a question about generalizability and points to clinicians’ persistent concern about early postPCI complications. 13. 12 Is Same-Day Discharge Safe After Percutaneous Coronary Intervention? Same-day discharge patients and those who stayed overnight had similar outcomes.4% versus 11. Previously prescribed medications were not refilled for significantly more patients who had been hospitalized than for nonhospitalized controls: 19. Although a fraction of these cases probably were intentional medication cessations. or emergency department visits). or those with recent readmissions.601 patients with a target INR of 2. but the small percentage of same-day discharges makes it difficult to assess the overall safety of the approach. 306:1461. those with prolonged hospitalizations. COMMENT transitions of care represent times of high risk for medication errors.55%).9% versus 9. We have few data on the safety of sameday discharge after percutaneous coronary intervention (PCI).92 CARDIOLOGY Rao SV et al. Mean TTR was >70% in all age groups.0% for levothyroxine. JAMA 2011 Oct 5. researchers have now compared outcomes in 1339 Medicareeligible patients who were discharged on the day of their elective PCI procedure with outcomes in 105. 23 days.0% for inhalers. Other study limitations include a lack of information on how long same-day discharge patients were observed and on why patients were or were not discharged the same day. To improve anticoagulation treatment. 12. Indications for warfarin included AF (64%). COMMENT When patients are hospitalized. or received bivalirudin or a glycoprotein IIb/IIIa inhibitor. However.6% versus 10. 13. At first glance. and 12.4% for acid-suppression agents. By linking National Cardiovascular Data Registry records from November 2004 through December 2008 with corresponding data from the Centers for Medicare & Medicaid Services.8% for antiplatelets and anticoagulants. Journal Watch Hospital Medicine Bell CM et al. discharge. Discontinuation rates for all medications were significantly higher among patients with ICU stays than among those without. The researchers excluded patients from nursing facilities. The highest adjusted odds ratios for discontinuation were for antiplatelet and anticoagulant agents among hospitalized patients as a whole (AOR. these findings underscore the importance of medication reconciliations on admission. Association of ICU or hospital admission with unintentional discontinuation of medications for chronic diseases. 1. several caveats should be noted. Herrmann.000 nonhospitalized older patients (age. Investigators attempted to exclude patients for whom medications had been stopped intentionally. so discontinuation rates in hospitalized patients likely are underestimated. 1. The fact that only 1. Secondary analyses showed that statin and antiplatelet and anticoagulation cessation each were associated with excess risk for adverse events (death. Time in Therapeutic Range for Warfarin — A European Success Story A Swedish registry and quality-improvement program resulted in a mean TTR of more than 75%.86) versus controls and for levothyroxine among ICU patients (AOR.2.29) versus hospitalized non-ICU patients. these data suggest that overnight hospitalization for uncomplicated elective percutaneous coronary intervention is unnecessary. JAMA 2011 Aug 24/31. we will need more safety data to help us ensure the safest approach for patients and identify those who are best suited for early discharge. and higher percentages correlated significantly with increasing age.391 patients (mean age. Participating anticoagulation centers use a Web-based dosing algorithm and are located in both primary care and hospital-based settings. emergent readmissions.679 patients who stayed overnight.8–3. how often are these medications restarted after discharge? To examine risk for medication errors of omission that are attributable to hospitalization (with or without an intensive care unit [ICU] stay). >65) who had been receiving one of five categories of medications for more than 1 year.0. — Grace C. providers sometimes modify or stop longstanding medications to focus on acute care. As reimbursement rules change to favor same-day discharge.5% versus 3.7% for statins.000 hospitalized and 210. and transfer between units within the same hospital. But. Significantly more same-day discharge than overnight patients underwent a transradial intervention (3. In 15.14% vs.6). — Howard C. mean samples/patientyear. the average time in therapeutic range (TTR) of international normalized ratio (INR) values has ranged from 56% in retrospective studies to 65% in randomized controlled trials.2%. The two groups did not differ significantly in the rate of death or rehospitalization at either 2 days or 30 days. but same-day discharge patients had significantly shorter procedures and required significantly less contrast agent. 70.3% versus 11. a strategy actively encouraged by reimbursement organizations. 306:840.142 INR samples at 67 centers (mean time between samples per patient.4%. MD. Huang. The two groups had similar baseline characteristics. received a femoral closure device (65% vs. the mean TTR increased to 88. 1. 40% women) with 250.
randomized. and the equivalence of surgical and endovascular revascularization. thus. Therefore. and values of 0. Society for Vascular Medicine. However. the recommendations for smoking-cessation interventions have been expanded: • The novel agent varenicline demonstrated superior smoking-cessation rates in several randomized. COMMENT 1. — Joel M.91 to 0. 2011 ACCF/AHA Focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): A report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines.99 are considered borderline (Class I). 3. so individual patient factors should be paramount in making revascularization decisions. controlled comparisons with nicotine replacement and bupropion (which yield 1-year quit rates of 16% and 30%. ABI values >1. 5. Sponsoring Organizations: American College of Cardiolo- gy. compared with 0.4 indicate noncompressible arteries.0% of smoking-cessation attempts involving physicians are successful. Since 2005. The Class I recommendation for clopidogrel as an alternative to aspirin therapy is unchanged. Several reports published since then have heightened doubts about the safety of varenicline. Society for Cardiovascular Angiography and Interventions. • . endovascular repair and surgery appear to provide equivalent outcomes for patients with PAD. and the range of abnormal values as ≤0. Equally important is diagnosing PAD at an early stage. therefore. 6:e27016). Long-term follow-up shows no significant difference in outcomes of open surgery versus balloon angioplasty. No prospective. Society of Interventional Radiology. for which several viable options are now available. the major advances in the management of peripheral arterial disease are in its prevention. ADDENDUM The guideline authors reviewed all evidence available through the end of 2010. 6. rather than ≥70. either in amputation-free or overall survival in patients with critical limb ischemia or in rates of overall and aneurysm-related morbidity and mortality in patients with abdominal aortic aneurysm. However.December 2011 JWatch. clinicians should choose the method of aneurysm repair that is deemed to be most appropriate for individual patients. Society for Vascular Surgery Background and Purpose: Changes to recommendations for the management of lower-extremity arterial and abdominal aortic disease reflect clinical-study evidence published since completion of the 2005 guidelines. as previously recommended (Class I). depressed mood. a Class IIb recommendation to consider the combination of aspirin and clopidogrel in patients with symptomatic lower-extremity PAD has been added.0 to 1. agitation. particularly smoking cessation. American Heart Association. Because peripheral arterial disease (PAD) is often underdiagnosed and undertreated before limb ischemic symptoms become severe.1% of attempts in individuals who try to quit spontaneously. Additional evidence has bolstered the Class III recommendation against the use of anticoagulation therapy in addition to antiplatelet therapy in PAD patients. prevention of cardiovascular events. controlled trials have examined the effects of smoking-cessation strategies on cardiovascular events in patients with lower-extremity PAD.9. and suicidal thoughts. Key Points: 4. Gore. J Am Coll Cardiol 2011 Nov 1. MD Rooke TW et al. 183:1359) as well as with behavioral and mood effects (PLoS ONE 2011. 58:2020. which have been associated with reports of changes in behavior. such as hostility. respectively) and is now recommended (Class I).4. This evidence suggests that varenicline should be moved to the back of the clinician’s arsenal of pharmacologic therapies for smoking cessation. Finally.org 93 CLINICAL PRACTICE GUIDELINE WATCH Focused Update: ACC/AHA Guidelines on Peripheral Arterial Disease Revised recommendations emphasize early detection of PAD. ankle–brachial indexes should be obtained regularly in all individuals older than 65. Lower procedural mortality with endovascular aneurysm repair was not sustained. 2. The 2005 recommendations regarding renal and mesenteric arterial disease remain unchanged in the absence of new pivotal studies of disease in these segments. observational studies show that 5. Caution is advised in the use of bupropion or varenicline. an ankle–brachial index (ABI) should now be obtained in all nondiabetic patients with suspected lower-extremity PAD who are aged ≥65. which has been associated with possible cardiovascular effects (CMAJ 2011. The range of normal ABI values is defined as 1.
MD Wieloch M et al. given the number of subjects that would be needed to test hard clinical outcomes. Nonetheless. p. scaffold coverage was similar to that observed with standard DESs. and the risk for thrombosis was 1. they could increase the proportion of patients with multivessel CAD who fall into lower-risk categories. Importantly. but superiority of a bioresorbable scaffold to current-generation metallic ones will be difficult to demonstrate. 32:2282. TTR rates in the warfarin arms of recent noninferiority trials were surprisingly low (JW Cardiol Sep 2011. two myocardial infarctions deemed unrelated to the stents. Bioresorbable Stent Ready for Randomized Evaluation One-year results of a phase II trial are encouraging. Potent emerging competitors to warfarin are expensive and lack extensive safety data beyond 2 years. 361:1139). and some return of normal vasomotion was seen. phase II evaluation of the latestgeneration bioresorbable vascular scaffold . Incidence of major bleeding increased significantly with increasing age (P<0. Bringing it all together: Integration of physiology with anatomy during cardiac catheterization. randomized trial comparing bioresorbable stents with current-generation DESs.001). Two-year results will be critical. 12 patients aged 41–50 to 24 mg/week in those aged 81–90 (P<0.27 mm. MD Serruys PW et al. 82. functional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) was associated with a reduction in major adverse events compared with PCI guided by angiography alone in patients with multivessel coronary artery disease (JW Cardiol Feb 2009. and N Engl J Med 2009. and N Engl J Med 2009. 58:1219. repeat revascularization).4% in patients with AF. this study builds on growing evidence for the need to integrate physiology and anatomy in revascularization decisionmaking. Meyer. such a trial will probably be able to demonstrate only noninferiority of this new technology. Intravascular ultrasound and optical coherence tomography confirmed no change in mean and minimal scaffold areas and >95% coverage of stent struts. rates of death or myocardial infarction (MI) at 1 year were 4. Herrmann. FSS was an independent predictor of 1-year adverse events and a better predictor of clinical outcome than the SYNTAX score in receiver-operator characteristic curve analysis.94 continued from page 92 CARDIOLOGY Vol. p. moreover. the risk for major bleeding was 2.6% per treatment year. Compared with the SYNTAX score alone. as the authors note. and JW Cardiol Oct 2009. intimal hyperplasia was slightly greater than that observed both in a different cohort of patients at 6 months and with drugeluting metallic stents (DESs). About one third of patients were reclassified from a higher-risk SYNTAX These findings demonstrate low rates of intimal hyperplasia and restenosis 12 months after implantation of a bioresorbable drugeluting stent. investigators examined the accuracy of a “functional SYNTAX score” (FSS) derived by recalculating the SYNTAX risk score using ischemia-producing lesions only (FFR measurements ≤0. its quality can and must be improved. Dauerman HL. warfarin treatment cannot yet be dismissed. however. Procedural success was high. major bleeding. not definitive advantages such as a reduced need for dual antiplatelet therapy or improved endothelial function. and N Engl J Med 2011. 65. Anticoagulation control in Sweden: Reports of time in therapeutic range. although.8%.8) and not including lesions with FFR >0. MI. — Howard C. respectively (P=0. However. 7. MD Nam C-W et al. as the scaffold takes 24 months to fully resorb. As noted by the editorialist. the FSS accentuated adverse events in the highest tertile of risk: 27% of patients with high-risk FSS versus 21% of patients with high-risk SYNTAX scores had major adverse events. In patients with low. In an outcomes analysis involving 4273 patients at two centers.005). and two ischemiadriven target-lesion revascularizations. 17 No. Eur Heart J 2011 Sep 18. 58:1589.7% per treatment year overall and 1.5%. Mean angiographic late lumen loss was 0. COMMENT is now under way. 365:883. A similar trend was observed for a composite rate of major adverse cardiac events (death. COMMENT Combining FAME and SYNTAX in a Functional Score Improves Risk Assessment Using ischemia-producing lesions only in the SYNTAX score reduces the number of highest-risk patients and improves prediction of adverse events in patients with multivessel CAD. If these findings are confirmed prospectively. J Am Coll Cardiol 2011 Oct 4. More than 10 years since the first clinical use of a polymer (L-lactide) bioabsorbable stent.8. with no deaths. — Howard C. and the restenosis rate was 3. Investigators for the manufacturer-sponsored trial report the results of planned invasive imaging 12 months after implantation of everolimuseluting bioresorbable stents in 56 patients with de novo coronary lesions. Some degree of arterial-segment vasodilation was found in 8 of 19 patients assessed with intracoronary acetylcholine. 58:1578. 13. but also is a better predictor of risk for adverse events in patients with multivessel coronary artery disease (CAD). 58:1211.8%. J Am Coll Cardiol 2011 Oct 4. in which percutaneous coronary intervention may be more appropriate than coronary artery bypass grafting. The magic of disappearing stents. These findings suggest that a functional SYNTAX score derived from ischemiaprovoking lesions only (as measured by functional flow reserve) not only reduces the number of highest-risk patients compared with the SYNTAX score. and thrombo-embolic complications from the national quality registry AuriculA. score tertile to a lower-risk FSS tertile.5%. In this analysis. medium. — Beat J. the authors conclude that the 1-year results are sufficiently promising to proceed with a large. p. In the FAME trial. J Am Coll Cardiol 2011 Sep 13. COMMENT These findings suggest that high TTR percentages with warfarin treatment can be achieved in an organized system. Kleiman NS. 360:213). Functional SYNTAX score for risk assessment in multivessel coronary artery disease. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. Herrmann. Thus. J Am Coll Cardiol 2011 Sep 13.001). and 15. and high FSS.
low-density lipoprotein (LDL) cholesterol.December 2011 JWatch. Rates of myocardial infarction and ischemic cardiovascular disease and death were significantly higher in patients with xanthelasma than in those without (cumulative incidence of all 3. P<0. • Relevant information and practical intelligence you can use • Brief reviews of the medical news that affects your practice • Gleaned from government agencies. and high-density lipoprotein (HDL) cholesterol and apolipoprotein A1 were lower. Predicts Atherosclerotic Vascular Disease and Death A relatively common clinical finding is a marker of increased risk for cardiovascular disease. Masoudi. ST-segment depression. experienced a non-fatal non-STsegment elevation myocardial infarction. BMJ 2011 Sep 15. dose-ranging phase 2 trial. During follow-up (mean. COMMENT It seems intuitive that agents that improve cardiac contractility would help patients with systolic dysfunction. Investigators studied 12. Such patients should be referred to their internists and. — Frederick A. NCT01300013 [http://clinicaltrials. crossover study. 343:d5497. Ultimately. placebocontrolled. to varying doses and durations of omecamtiv infusion. investigators randomized 45 patients (87% men) with clinical heart failure and systolic dysfunction (64% with an ischemic etiology) It is difficult not to be excited at the prospect of a therapeutic breakthrough for patients with heart failure in whom morbidity and mortality remain persistently high despite the best available treatment. We should be prepared to make patients aware that the condition may indicate future de- Visit JWatch. MSPH. COMMENT Omecamtiv Shows Early Promise for Heart Failure In phase I and II trials. Xanthelasma (a sharply demarcated yellowish deposit of cholesterol underneath the skin.m. 34 healthy volunteers received a 6-hour. In a phase II. However. Cleland JGF et al. Xanthelasmata.745 people enrolled in the Copenhagen City Heart Study that began in 1976. and 8507 died. At baseline. One of these had an elevation in troponin level. on cardiac function in systolic heart failure: A double-blind. 378:676. Two manufacturer-sponsored studies now provide early insights into the possible use of omecamtiv mecarbil. and arcus senilis in 24. and levosimendan (a calcium sensitizer unavailable in the U. The effects on the cardiac myosin activator. Unfortunately. Levels of total cholesterol. double-blind. to preventive cardiology clinics.S. xanthelasma was identified in 4. MD. Disappointing experiences with other inotropes naturally tempers this enthusiasm. Omecamtiv resulted in concentration-dependent increases in systolic ejection time (≤80 msec) and LV stroke volume (≤9. existing agents — including dobutamine (an adrenergic stimulant). omecamtiv produced significant increases in systolic ejection time (85 msec). studies examining meaningful clinical outcomes and safety will determine omecamtiv’s fate. many in the medical community believe that a finding of xanthelasma or arcus senilis is benign and unrelated to atherosclerosis or death. left ventricular (LV) ejection fraction (7%). FACC. perhaps. but their exact pathogeneses are not known. velopment of atherosclerotic disease.5 mg/kg/hour. Lancet 2011 Aug 20. intravenous infusion of omecamtiv or placebo once weekly in escalating doses for 4 weeks. The increases in risks for disease and death in participants with xanthelasma were independent of other known risk factors for atherosclerotic heart disease. crossover. A larger phase II trial in 600 patients is now under way (clinicaltrials. usually on or around the eyelid) and arcus senilis (a white or gray ring in the cornea or around the iris) are relatively common findings. One of these. The maximum dose tolerated by ≥8 participants was 0. Journal Watch Dermatology Christoffersen M et al.7 mL) and slight reductions in heart rate (≤2. In a phase I study. milrinone (a phosphodiesterase inhibitor). Save time and stay informed with a FREE daily e-mail alert. 1872 participants developed myocardial infarction. Both appear to be manifestations of cholesterol esters in the skin or cornea. Callen. in animal models. 1498 developed ischemic stroke. and ischaemic vascular disease and death in general population: Prospective cohort study. The relationship of these findings to serum lipids is imperfect. a cardiac myosin activator safely improved systolic function without increasing myocardial oxygen consumption. and other key sources • Delivered to your e-mail box each weekday by 7:30 a. ET This powerful finding regarding a relatively common clinical entity suggests that dermatologists are likely to be the first to recognize a marker of increased cardiovascular risk in patients with xanthelasma. journals.org 95 Xanthelasma.org to sign up FREE . 3699 developed ischemic heart disease. who had inadvertently received an overdose.gov/ct2/show/ NCT01300013]). but many studies have linked their presence to elevated serum lipids.001). in persons with either disorder. Five patients withdrew because of adverse events. a novel selective cardiac myosin activator that. Two patients experienced signs and symptoms of myocardial ischemia at relatively high plasma omecamtiv concentrations.4% of enrolled patients. Lancet 2011 Aug 20. 1815 developed ischemic cerebrovascular disease.) — are associated with morbidity and mortality that outweigh their benefits. Differences in risk between patients with and without arcus senilis were not significant. and LV fractional shortening (8%) that correlated strongly with plasma concentrations of omecamtiv. increases cardiac contractility without increasing intracellular calcium. 378:667. arcus corneae. but Not Arcus Senilis. Dose-dependent augmentation of cardiac systolic function with the selective cardiac myosin activator. and chest pain without subsequent magnetic resonance imaging evidence of infarction. placebocontrolled. and triglycerides were higher. three of whom had signs or symptoms suggesting myocardial ischemia at high omecamtiv concentrations. double-blind. omecamtiv mecarbil. apolipoprotein B.8%. MD.7 bpm). omecamtiv mecarbil: A firstin-man study. 22 years). FAHA Teerlink JR et al.gov. At this dose. — Jeffrey P.
the SAPIEN transcatheter heart valve has now received FDA approval for this indication. The TAVI and standard-therapy groups both had low mean baseline KCCQ summary and SF-12 scores. 12 Quality of Life Improves After Transcatheter Aortic Valve Implantation One-year health-related quality-of-life findings from the PARTNER trial are encouraging.7 points at 12 months) and on the SF-12 mental summary (3. DO. 21 points at 6 months. Printed in the USA. FACC. 94) In an analysis of data from the FAME trial. transcatheter aortic valve implantation (TAVI) was shown to confer survival and symptom-relief benefits compared with standard therapy (JW Cardiol Nov 2010. and N Engl J Med 2010.85 D. 364:2187). these meaningful QOL improvements suggest that TAVI should be considered a valuable therapeutic option for inoperable patients with severe aortic stenosis. Massachusetts Medical Society 860 Winter Street Waltham.org 96 CARDIOLOGY Vol. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis.org User name and password are required. p. assessments were made with the Kansas City Cardiomyopathy Questionnaire (KCCQ).JW ONLINE CME JOURNAL WATCH SUBSCRIBERS HAVE 10 FREE CREDITS! This is one of four questions in a recent Journal Watch Online CME exam. Indeed. is a coauthor of the summarized article but had no role in its selection or review. involving 358 elderly patients with severe aortic stenosis who were not candidates for surgery. 0. Cardiology No part of this newsletter may be reproduced or otherwise incorporated into any information retrieval system without the written permission of the Massachusetts Medical Society. ISSN 1521-5822. and N Engl J Med 2011. reflecting relatively poor QOL. 0. 17 No. disease-specific health status on a 100-point scale. The advantages surfaced as early as 1 month and continued to accrue through 1 year. which measures patientreported. — Beat J. 0. from “Combining FAME and SYNTAX in a Functional Score Improves Risk Assessment ” (p.95 B. MD Journal Watch Cardiology Deputy Editor Howard C. COMMENT In the industry-funded PARTNER trial. 0. p. Investigators now report on health-related quality of life (QOL) among the trial’s participants. The findings from this preplanned PARTNER substudy suggest that transcatheter aortic valve implantation yields substantial quality-of-life benefits over Reynolds MR et al. Herrmann. At baseline and at 1. CME FACULTY Kelly Anne Spratt. Despite increased risks for both stroke and major vascular complications with TAVI (JW Cardiol Jul 2011. 363:1597). and 12 months.5 points at 1 month to 5. 6. MA 02451-1413 JWatch. 124:1964. and 26 points at 12 months. for the Placement of Aortic Transcatheter Valves (PARTNER) Investigators.4 points at 12 months). Section Editor. 85.2 points at 6 months and 6. . investigators calculated a “functional SYNTAX score” to guide PCI by including only lesions with FFRs less than or equal to which of the following values? A. Circulation 2011 Nov 1. Meyer. MD. Short Form-12 (SF-12) Health Survey.jwatch. and with the 12-item standard therapy.80 Category: Cardiovascular Diseases Exam Title: Assessing Lesion Severity for Coronary Revascularization Posted Date: Nov 15 2011 View this exam and others at http://cme. The KCCQ summary score improved from baseline in both groups but significantly more in the TAVI group: The mean difference between the groups was 13 points at 1 month. 56. The TAVI group also showed significant improvements over the standard-therapy group on the SF-12 physical summary (differences ranged from 4.90 C.
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