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Sana M Al-Khatib
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ABSTRACT: In recent years, electrophysiology clinical research has made tremendous progress. Not only have the standards for conducting research and assessing clinical outcomes improved substantially, but the power of well-conducted and designed randomized clinical trials has been realized. This has led to the emergence of a plethora of randomized clinical trials in electrophysiology. Despite these improvements, there is an immense need to explore and develop better approaches for assessing clinical outcomes. In this article, I review the strengths, challenges, and limitations of randomized clinical trials, especially as they relate to the field of electrophysiology. To address some of these challenges, I propose potential solutions that involve enhancing clinical trials and complementing them with large registries and databases of electronic medical records. If prudently developed and executed, these new directions in assessing clinical outcomes have great potential to inform, and thereby improve the care of patients receiving electrophysiologic interventions.
Journal of Interventional Cardiac Electrophysiology 08/2011; 32(3):221-6. · 1.17 Impact Factor
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ABSTRACT: Chronic kidney disease (CKD) is increasingly prevalent, and is an independent risk factor for cardiovascular mortality. Clinical trials of the implantable cardioverter-defibrillator (ICD) have demonstrated a survival benefit over medical therapy for the prevention of sudden cardiac death, but its benefit in patients with concomitant CKD is unclear.
We studied 199 subjects with CKD, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m(2), who underwent ICD implantation in the Duke Electrophysiology Genetic and Genomic Studies (EPGEN) biorepository. The mean age of the cohort was 67.8 ± 9.3 years, and the mean eGFR was 41.1 ± 13.2 mL/min/1.73 m(2). There were 63 deaths over a mean follow-up of 31.1 ± 18.8 months, corresponding to an annual mortality rate of 12.2%. Additionally, there was a 7% annual rate of appropriate ICD therapy. Using Cox regression analysis, older age, lower ejection fraction, and lower eGFR were found to be significant predictors of mortality. There was a gradient of risk associated with lower renal function: a 10 mL/min reduction in eGFR conferred a 48% increase in the risk of death (P < 0.001). Further adjustment for appropriate ICD therapy did not modify these associations.
In patients with CKD treated with a defibrillator, more advanced renal dysfunction is associated with reduced survival despite appropriate defibrillator therapy. This may be due to competing mortality risks in this population that attenuate the benefit of the ICD in reducing arrhythmic death. Age, ejection fraction, and kidney disease severity can be used to risk stratify patients before device implantation.
Europace 08/2011; 13(12):1717-22. · 1.98 Impact Factor
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Zubin J Eapen,
Eric D Peterson,
Gregg C Fonarow,
Gillian D Sanders,
Clyde W Yancy,
Samuel F Sears,
Mark D Carlson,
Anne B Curtis,
Laura Lee Hall,
David L Hayes,
Adrian F Hernandez,
Michael Mirro,
Eric Prystowsky,
Andrea M Russo,
Kevin L Thomas, Sana M Al-Khatib
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ABSTRACT: Sudden cardiac arrest (SCA) is the most common cause of death in the United States. Despite national guidelines, patients at risk for SCA often fail to receive evidence-based therapies. Racial and ethnic minorities and women are at particularly high risk for undertreatment. To address the persistent challenges in improving the quality of care for SCA, the Duke Center for the Prevention of Sudden Cardiac Death at the Duke Clinical Research Institute (Durham, NC) reconvened the Sudden Cardiac Arrest Thought Leadership Alliance. Experts from clinical cardiology, cardiac electrophysiology, health policy and economics, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality, and device and pharmaceutical manufacturers discussed the development of SCA educational tools for patients and providers, mechanisms of implementing successful tools to help providers identify patients in their practice at risk for SCA, disparities in SCA prevention, and performance measures related to SCA care. This article summarizes the discussions held at this meeting.
American heart journal 08/2011; 162(2):222-31. · 4.65 Impact Factor
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N A Mark Estes,
Ralph L Sacco, Sana M Al-Khatib,
Patrick T Ellinor,
Judy Bezanson,
Alvaro Alonso,
Charles Antzelevitch,
Randall G Brockman,
Peng-Sheng Chen,
Sumeet S Chugh, [......],
Richard Lee,
Douglas L Packer,
Sunny S Po,
Eric N Prystowsky,
Susan Redline,
Yves Rosenberg,
David R Van Wagoner,
Kathryn A Wood,
Lixia Yue,
Emelia J Benjamin
Circulation 06/2011; 124(3):363-72. · 14.74 Impact Factor
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ABSTRACT: This study was designed to determine if physicians' attitudes and recommendations surrounding implantable cardioverter-defibrillators (ICDs) are regionally associated with ICD use.
A national sample of 9969 members of the American College of Cardiology was surveyed electronically. Responses were merged with rates of ICD implantation from the National Cardiovascular Data Registry. Multivariable regression was used to assess trends between regional use and responses. We received 1210 responses (12%) and used 1124 after exclusions. Across regions, physicians were equally likely to recommend ICDs to males or females with ischemic (∼99% for both; P = NS) or nonischemic cardiomyopathy (85 vs. 88% P = 0.85). Significant increasing trends in the probability recommending ICD therapy were found when the patient was "frail" (21% to 32%; P = .03) or had a life expectancy <1 year (5% to 10%; P = .05). These differences were not associated with attitudes toward ICDs.
Independent of variations in physicians' attitudes towards ICDs, physicians in regions of low ICD use are not less likely to recommend ICDs in situations clearly supported by guidelines while those in regions of high ICD use are more likely to recommend ICDs to patients who might have limited benefit.
Journal of cardiac failure 04/2011; 17(4):318-24. · 3.25 Impact Factor
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Sana M Al-Khatib
Circulation Cardiovascular Quality and Outcomes 03/2011; 4(2):140-2. · 4.91 Impact Factor
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ABSTRACT: The need for consistent and current data describing the true incidence of sudden cardiac arrest (SCA) and/or sudden cardiac death (SCD) was highlighted during the most recent Sudden Cardiac Arrest Thought Leadership Alliance's (SCATLA) Think Tank meeting of national experts with broad representation of key stakeholders, including thought leaders and representatives from the American College of Cardiology, American Heart Association, and the Heart Rhythm Society. As such, to evaluate the true magnitude of this public health problem, we performed a systematic literature search in MEDLINE using the MeSH headings, "death, sudden" OR the terms "sudden cardiac death" OR "sudden cardiac arrest" OR "cardiac arrest" OR "cardiac death" OR "sudden death" OR "arrhythmic death." Study selection criteria included peer-reviewed publications of primary data used to estimate SCD incidence in the U.S. We used Web of Science's Cited Reference Search to evaluate the impact of each primary estimate on the medical literature by determining the number of times each "primary source" has been cited. The estimated U.S. annual incidence of SCD varied widely from 180,000 to >450,000 among 6 included studies. These different estimates were in part due to different data sources (with data age ranging from 1980 to 2007), definitions of SCD, case ascertainment criteria, methods of estimation/extrapolation, and sources of case ascertainment. The true incidence of SCA and/or SCD in the U.S. remains unclear, with a wide range in the available estimates that are badly dated. As reliable estimates of SCD incidence are important for improving risk stratification and prevention, future efforts are clearly needed to establish uniform definitions of SCA and SCD and then to prospectively and precisely capture cases of SCA and SCD in the overall U.S. population.
Journal of the American College of Cardiology 02/2011; 57(7):794-801. · 14.16 Impact Factor
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ABSTRACT: Several studies that used claims and registry data have reported that 40% to 80% of patients eligible for an implantable cardioverter defibrillator (ICD) fail to receive one in clinical practice, and the rates are especially high among women and blacks. The extent and documented reasons for nonuse of ICDs among patients with left ventricular systolic dysfunction are unknown.
Using hospital claims and clinical data, we identified patients hospitalized with a heart failure diagnosis and left ventricular ejection fraction ≤30% between January 1, 2007, and August 30, 2007, at a tertiary-care center. Using claims data, we determined placement of an ICD or cardiac resynchronization therapy with defibrillation device at any time up to 1 year after hospitalization. Medical records for patients without an ICD were abstracted to determine reasons for nonuse. Patients with an ICD were compared with patients without an ICD and also with patients without an ICD who did not have any contraindication for an ICD as identified through chart abstraction. Of the 542 potentially eligible patients identified, 224 (41%) did not have an ICD. In the initial adjusted analysis, female sex (odds ratio=1.90; 95% CI, 1.28 to 2.81) and increasing age (odds ratio=1.07; 95% CI, 1.04 to 1.11) were associated with a higher likelihood of not having an ICD. After detailed chart review, of the 224 patients without an ICD, 117 (52%) were ineligible for the device and 38 (17%) patients refused the device, resulting in only 69 (13%) patients eligible for an ICD who failed to receive one. In this subsequent adjusted analysis, remaining factors associated with a higher likelihood of not having an ICD were absence of ventricular arrhythmias (odds ratio=4.93; 95% CI, 2.56 to 9.50), noncardiology hospital service (odds ratio=3.73; 95% CI, 1.98 to 7.04), and lack of health insurance (odds ratio=3.10; 95% CI, 1.48 to 6.46).
On the basis of a detailed chart review, the true rate of ICD underuse may be substantially lower than previous estimates. In addition, after accounting for ICD eligibility criteria, patient sex and age disparities in ICD therapy were no longer present.
Circulation Cardiovascular Quality and Outcomes 02/2011; 4(2):146-51. · 4.91 Impact Factor
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ABSTRACT: Implantable cardioverter defibrillator (ICD) therapy improves survival of patients with systolic heart failure. We assessed whether physicians' recommendation for ICD therapy varies as a function of patient age, gender, race, and physician's specialty.
We surveyed a random sample (n = 9969) of U.S. physicians who are active members of the American College of Cardiology (ACC). We asked participants about their likelihood to recommend ICD therapy in 4 clinical scenarios that randomly varied patient age, gender, race, and ICD indication (guideline Class I, Class IIa, Class III, and Class I in a noncompliant patient).
Responses were received from 1210 physicians (response rate 12%), of whom 1127 met the study inclusion criteria. Responders and nonresponders had similar demographics. In responding to hypothetical clinical scenarios, physicians were less likely to recommend an ICD to older patients (≥80 vs 50 years) (P < 0.01) but were unaffected by gender or race for all class indications. Compared with non-electrophysiologists (EPs), EPs were significantly more likely to recommend an ICD for a Class I indication (92.4% vs 81.4%; P < 0.01), but they were not more likely to offer an ICD for a Class III indication (0.4% vs 0.6%; P = 0.95).
Based on survey responses, physicians were equally willing to offer an ICD to men and women and to whites and blacks, but were less likely to offer an ICD to an older patient even when indicated by practice guidelines. Electrophysiologists (EPs) more often adhered to practice guideline recommendations on ICD therapy compared with non-EPs.
Annals of Noninvasive Electrocardiology 01/2011; 16(1):77-84. · 1.10 Impact Factor
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ABSTRACT: Practice guidelines do not recommend use of an implantable cardioverter-defibrillator (ICD) for primary prevention in patients recovering from a myocardial infarction or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure.
To determine the number, characteristics, and in-hospital outcomes of patients who receive a non-evidence-based ICD and examine the distribution of these implants by site, physician specialty, and year of procedure.
Retrospective cohort study of cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 1, 2006, and June 30, 2009.
In-hospital outcomes.
Of 111,707 patients, 25,145 received non-evidence-based ICD implants (22.5%). Patients who received a non-evidence-based ICD compared with those who received an evidence-based ICD had a significantly higher risk of in-hospital death (0.57% [95% confidence interval {CI}, 0.48%-0.66%] vs 0.18% [95% CI, 0.15%-0.20%]; P <.001) and any postprocedure complication (3.23% [95% CI, 3.01%-3.45%] vs 2.41% [95% CI, 2.31%-2.51%]; P <.001). There was substantial variation in non-evidence-based ICDs by site. The rate of non-evidence-based ICD implants was significantly lower for electrophysiologists (20.8%; 95% CI, 20.5%-21.1%) than nonelectrophysiologists (24.8% [95% CI, 24.2%-25.3%] for nonelectrophysiologist cardiologists; 36.1% [95% CI, 34.3%-38.0%] for thoracic surgeons; and 24.9% [95% CI, 23.8%-25.9%] for other specialties) (P<.001 for all comparisons). There was no clear decrease in the rate of non-evidence-based ICDs over time (24.5% [6908/28,233] in 2006, 21.8% [7395/33,965] in 2007, 22.0% [7245/32,960] in 2008, and 21.7% [3597/16,549] in 2009; P <.001 for trend from 2006-2009 and P = .94 for trend from 2007-2009).
Among patients with ICD implants in this registry, 22.5% did not meet evidence-based criteria for implantation.
JAMA The Journal of the American Medical Association 01/2011; 305(1):43-9. · 30.03 Impact Factor
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ABSTRACT: Randomized clinical trials (RCTs) have demonstrated the efficacy of implantable cardioverter-defibrillators (ICDs) in reducing sudden cardiac death (SCD) in specific patient populations. However, patients ≥ 65 years were under-represented in these trials and the overall benefit of ICDs may be diminished in older patients due to competing risks for death. We evaluate the published data on ICD efficacy at reducing all-cause mortality in patients ≥ 65 years and in patients ≥ 75 years.
We searched MEDLINE to identify RCTs and observational studies of ICDs that provided age-based outcome data for primary prevention of SCD. The primary endpoint was mortality evaluated by a meta-analysis of the RCTs using a random-effects model. Secondary endpoints included operative mortality, long-term complications and quality of life.
The enrollment of patients ≥ 65 years in RCTs was limited (range: 33% in DEFINITE to 56% in MUSTT). Combining data from four RCTs (n = 3,562) revealed that primary prevention ICD therapy is efficacious in reducing all-cause mortality in patients ≥ 65 years (HR 0.66; 95% CI 0.50-0.87; test of heterogeneity: X(2) = 5.26; p = 0.15). For patients ≥ 75 years, combining data from four RCTs (n = 579) revealed that primary prevention ICD therapy remains efficacious in reducing all-cause mortality (HR 0.73; 95% CI 0.51-0.974; p = 0.03). There appears to be no difference in ICD-related, operative, in-hospital, or long- -term complications among older patients compared to younger patients, although it remains unclear if older patients have a better quality of life with an ICD than younger patients.
Although the overall evidence regarding ICD efficacy in patients ≥ 65 years is limited and divergent, and the evidence available for patients ≥ 75 years is even more sparse, our meta-analysis suggests that primary prevention ICDs may be beneficial in older patients. Our findings need to be validated by future studies, particularly ones examining ICD complications and quality of life.
Cardiology journal 01/2011; 18(5):503-14. · 1.31 Impact Factor
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ABSTRACT: The implantable cardioverter-defibrillator (ICD) is an effective therapy for preventing sudden cardiac death (SCD) in patients with prior myocardial infarction (MI) and reduced left ventricular function; however, the optimal timing of ICD implantation after MI remains unknown.
The purpose of this study was to determine whether the benefit of single-lead conservatively programmed ICD therapy varies as a function of time from MI to ICD implantation.
We compared time to all-cause death and SCD between the ICD and placebo arms in the Sudden Cardiac Death in Heart Failure Trial. Rates of appropriate shocks in the ICD arm were also assessed as a function of time after MI.
Among the 712 patients with a history of MI, 274 died (38.5%), and 68 of these deaths were SCD (24.8%). Appropriate shocks were more common with increasing time after MI (adjusted hazard ratio [HR] per year after MI 1.04 [1.00-1.08]). Despite these differences, there was no evidence of differential mortality benefit with ICD implantation as a function of time after MI: continuous variable adjusted HR 1.00 [0.98,1.03] and shortest versus longest tertile adjusted HR 0.95 [0.66-1.34]. Sensitivity analyses also failed to show differential mortality benefit by quartile or with the use of an 18-month cutoff: <18 versus ≥ 18 months adjusted HR 1.08 [0.77, 1.51].
There is no evidence that ICD benefit varied with time from MI to implantation/randomization in this primary prevention population. Single-lead ICD benefit is not restricted to patients with a remote MI (>18 months).
Heart rhythm: the official journal of the Heart Rhythm Society 11/2010; 8(3):393-400. · 4.56 Impact Factor
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Sana M Al-Khatib,
Hugh Calkins,
Benjamin C Eloff,
Peter Kowey,
Stephen C Hammill,
Kenneth A Ellenbogen,
Danica Marinac-Dabic,
Albert L Waldo,
Ralph G Brindis,
David J Wilbur,
Warren M Jackman,
Marcia S Yaross,
Andrea M Russo,
Eric Prystowsky,
Paul D Varosy,
Thomas Gross,
Ellen Pinnow,
Mintu P Turakhia,
Mitchell W Krucoff
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ABSTRACT: Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and long-standing persistent AF remain uncertain. Brisk adoption of this therapy by physicians with diverse training and experience highlights potential concerns regarding the safety and effectiveness of this procedure. Some of these concerns could be addressed by a national registry of AF ablation procedures such as the Safety of Atrial Fibrillation Ablation Registry Initiative that was initially proposed at a Cardiac Safety Research Consortium Think Tank meeting in April 2009. In January 2010, the Cardiac Safety Research Consortium, in collaboration with the Duke Clinical Research Institute, the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, held a follow-up meeting of experts in the field to review the construct and progress to date. Other participants included the National Heart, Lung, and Blood Institute; the Centers for Medicare and Medicaid Services; the Agency for Healthcare Research and Quality; the AdvaMed AF working group; and additional industry representatives. This article summarizes the discussions that occurred at the meeting of the state of the Safety of Atrial Fibrillation Ablation Registry Initiative, the identification of a clear pathway for its implementation, and the exploration of solutions to potential issues in the execution of this registry.
American heart journal 10/2010; 160(4):619-26. · 4.65 Impact Factor
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Melissa H Kong,
Eric D Peterson,
Gregg C Fonarow,
Gillian D Sanders,
Clyde W Yancy,
Andrea M Russo,
Anne B Curtis,
Samuel F Sears,
Kevin L Thomas,
Susan Campbell,
Mark D Carlson,
Chris Chiames,
Nakela L Cook,
David L Hayes,
Michelle LaRue,
Adrian F Hernandez,
Edward L Lyons, Sana M Al-Khatib
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ABSTRACT: Sudden cardiac arrest (SCA) is the most common cause of death in the Unites States. Despite its major impact on public health, significant challenges exist at the patient, provider, public, and policy levels with respect to raising more widespread awareness and understanding of SCA risks, identifying patients at risk for SCA, addressing barriers to SCA care, and eliminating disparities in SCA care and outcomes. To address many of these challenges, the Duke Center for the Prevention of Sudden Cardiac Death at the Duke Clinical Research Institute (Durham, NC) held a think tank meeting on December 7, 2009, convening experts on this issue from clinical cardiology, cardiac electrophysiology, health policy and economics, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality, and device and pharmaceutical manufacturers. The specific goals of the meeting were to examine existing educational tools on SCA for patients, health care providers, and the public and explore ways to enhance and disseminate these tools; to propose a framework for improved identification of patients at risk of SCA; and to review the latest data on disparities in SCA care and explore ways to reduce these disparities. This article summarizes the discussions that occurred at the meeting.
American heart journal 10/2010; 160(4):605-18. · 4.65 Impact Factor
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Stephen C Hammill,
Mark S Kremers,
Lynne Warner Stevenson,
Paul A Heidenreich,
Christine M Lang,
Jeptha P Curtis,
Yongfei Wang,
Charles I Berul,
Alan H Kadish, Sana M Al-Khatib,
Ileana L Pina,
Mary Norine Walsh,
Michael J Mirro,
Bruce D Lindsay,
Matthew R Reynolds,
Kathryn Pontzer,
Laura Blum,
Frederick Masoudi,
John Rumsfeld,
Ralph G Brindis
Heart rhythm: the official journal of the Heart Rhythm Society 09/2010; 7(9):1340-5. · 4.56 Impact Factor
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ABSTRACT: The aim of this study was to determine whether single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an effective method of risk stratification for sudden cardiac death (SCD) in patients with coronary artery disease (CAD) and left ventricular ejection fraction (LVEF)>35%.
Most victims of SCD have an LVEF>35%.
The study population included 4,865 patients with CAD and LVEF>35% who underwent gated SPECT MPI. We used Cox proportional hazard modeling to examine the relationship between patient characteristics and SCD.
The median age of the population was 63 years (25th, 75th percentile: 54, 71 years), and the median LVEF was 56% (25th, 75th percentile: 50%, 64%). The median follow-up for all patients was 6.5 years (25th, 75th percentile: 3.6, 9.3 years). During follow-up, there were 161 SCDs (3.3%). After multivariable adjustment, LVEF, the Charlson index, hypertension, smoking, antiarrhythmic drug therapy, and the summed stress score (SSS) were associated with SCD (all p<0.05). For each 3-U increase in the SSS, the hazard ratio for SCD was 1.13 (95% confidence interval: 1.04 to 1.23). The addition of perfusion data to the clinical history and LVEF was associated with increased discrimination for SCD events (c-index 0.728). Risk stratification with a derived SPECT nomogram did not result in statistically significant net reclassification improvement (p=0.26) or integrated discrimination improvement (p=0.38).
Among patients with CAD and LVEF>35%, the extent of stress MPI perfusion defects is associated with an increased risk of SCD. Future large prospective studies should address the role of perfusion imaging in the identification of high-risk patients with LVEF>35% who might benefit from ICD implantation.
Journal of the American College of Cardiology 07/2010; 56(3):206-14. · 14.16 Impact Factor
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ABSTRACT: More than 80% of sudden cardiac deaths (SCDs) occur in patients >or=65 years old; the cost-effectiveness of implantable cardioverter defibrillator (ICD) therapy in older patients remains unclear. We sought to examine the cost-effectiveness of ICD therapy in at-risk patients >or=65 years old.
We developed a Markov model to evaluate lifetime costs and benefits of ICD therapy compared with optimal medical therapy in patients >or=65 years of age with left ventricular dysfunction. Data were derived from the literature and existing clinical trials of primary prevention of SCD. Outcome measures included life years, quality-adjusted life years, costs, and incremental cost-effectiveness.
Benefits and costs of ICD therapy in older individuals varied widely by clinical-trial population. In the 5 trials considered, for patients >or=65 years of age, ICDs demonstrated a life expectancy benefit compared with control therapy (incremental cost-effectiveness ratios ranging from $37,031-$138,458 per quality-adjusted life year). For 75-year-old patients, the findings were qualitatively similar, although cost-effectiveness was reduced in all trial populations. In sensitivity analyses, cost-effectiveness of ICD therapy in older individuals depended upon the trial population, quality of life, device cost, and frequency of generator replacement. Sensitivity analyses on other variables did not change the results substantially.
The cost-effectiveness of ICD therapy for primary prevention in older patients varies widely among trials. Given an aging US population and the high risk of SCD in these individuals, further studies of ICD therapy and their cost-effectiveness-specifically in older patients-are needed.
American heart journal 07/2010; 160(1):122-31. · 4.65 Impact Factor
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ABSTRACT: Although no clinical trial data exist on the optimal management of atrial fibrillation (AF) in patients with diastolic heart failure, it has been hypothesized that rhythm-control is more advantageous than rate-control due to the dependence of these patients' left ventricular filling on atrial contraction. We aimed to determine whether patients with AF and heart failure with preserved ejection fraction (EF) survive longer with rhythm versus rate-control strategy.
The Duke Cardiovascular Disease Database was queried to identify patients with EF > 50%, heart failure symptoms and AF between January 1,1995 and June 30, 2005. We compared baseline characteristics and survival of patients managed with rate- versus rhythm-control strategies. Using a 60-day landmark view, Kaplan-Meier curves were generated and results were adjusted for baseline differences using Cox proportional hazards modeling.
Three hundred eighty-two patients met the inclusion criteria (285 treated with rate-control and 97 treated with rhythm-control). The 1-, 3-, and 5-year survival rates were 93.2%, 69.3%, and 56.8%, respectively in rate-controlled patients and 94.8%, 78.0%, and 59.9%, respectively in rhythm-controlled patients (P > 0.10). After adjustments for baseline differences, no significant difference in mortality was detected (hazard ratio for rhythm-control vs rate-control = 0.696, 95% CI 0.453-1.07, P = 0.098).
Based on our observational data, rhythm-control seems to offer no survival advantage over rate-control in patients with heart failure and preserved EF. Randomized clinical trials are needed to verify these findings and examine the effect of each strategy on stroke risk, heart failure decompensation, and quality of life.
Annals of Noninvasive Electrocardiology 07/2010; 15(3):209-17. · 1.10 Impact Factor
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ABSTRACT: The optimal timing of implantable cardioverter defibrillator (ICD) placement for the primary prevention of sudden cardiac death after myocardial infarction (MI) remains unknown.
We developed a Markov model to investigate the optimal timing of ICD implantation after MI (no ICD, ICD at 60 days, 6 months, and 1 year) in patients who meet current guidelines. Estimates of arrhythmic death (baseline risk 6%, range 1-20% per year), nonarrhythmic death, and ICD efficacy were based upon MADIT-II and other contemporary post-MI clinical trials. We used both deterministic and stochastic modeling processes in our analysis. After 10 years follow-up, the baseline probability of survival was higher in those treated with ICD implantation versus not (42% vs 30%, P < 0.001). Survival was highest with ICD implantation at 60 days versus 6 months versus 1 year: 42.4%, 42.3%, and 42.0% (P = 0.0028). ICD implantation at 60 days provided a mean incremental survival of 0.28 months and 0.84 months per patient (compared with implantation at 6 months and 1 year). In sensitivity analyses, patients' competing risk for nonarrhythmic death was the primary determinant of benefit from ICD implantation. Overall, ICD implantation at 60 days resulted in the greatest life expectancy over a wide range of plausible nonarrhythmic and arrhythmic death rates.
The benefits of early ICD implantation are modest when compared with delayed implantation at 6 months/1 year. Our results suggest that making sure a patient receives an ICD, when appropriate, may be more important than the timing of the implantation procedure.
Journal of Cardiovascular Electrophysiology 07/2010; 21(7):791-8. · 3.06 Impact Factor
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Kent R Nilsson, Sana M Al-Khatib,
Yi Zhou,
Karen Pieper,
Harvey D White,
Aldo P Maggioni,
Lars Kober,
Christopher B Granger,
Eldrin F Lewis,
John J V McMurray,
Robert M Califf,
Eric J Velazquez
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ABSTRACT: The management of patients with atrial fibrillation (AF) following a myocardial infarction (MI) remains uncertain. This study compared a rate control strategy to an anti-arrhythmic-based rhythm control strategy for the treatment of AF following myocardial infarction.
We studied 1131 patients with AF after MI who were enrolled in the Valsartan in Acute Myocardial Infarction Trial (VALIANT). We classified patients into those treated with a rhythm control strategy (n=371) and those treated with a rate control strategy (n=760).
Using Cox models, we compared the two groups with respect to both death and stroke during two different time periods after randomisation for which data collection had been pre-specified: 0-45 days and 45-1096 days.
After adjustment, a rhythm control strategy was found to be associated with increased early mortality (0-45 days: HR: 1.9, 95% CI 1.2 to 3.0, p=0.004) but not late mortality (45-1096 days: HR 1.1, 95% CI 0.9 to 1.4, p=0.45). No difference was observed in the incidence of stroke (0-45 days: HR 1.2, 95% CI 0.4 to 3.7, p=0.73; 45-1096 days: HR 0.6, 95% CI 0.3 to 1.3, p=0.21).
In patients with AF after an MI, an anti-arrhythmic drug-based rhythm control strategy is associated with excess 45-day mortality compared with a rate control strategy, but is not associated with increased mortality outside of the immediate peri-infarct period. These results potentially identify a patient population in whom the use of anti-arrhythmic drug therapy may portend an increased risk of death.
Heart (British Cardiac Society) 06/2010; 96(11):838-42. · 4.22 Impact Factor
