Vinay Kini

Appropriateness of primary prevention implantable cardioverter- defibrillators at the time of generator replacement: Are indications still met?

OBJECTIVES This study sought to determine how often patients with primary prevention implantable cardioverter-defibrillators (ICDs) meet guideline-derived indications at the time of generator replacement. BACKGROUND Professional societies have developed guideline criteria for the appropriate implantation of an ICD for the primary prevention of sudden cardiac death. It is unknown whether patients continue to meet criteria when their devices need replacement for battery depletion. METHODS We performed a retrospective chart review of patients undergoing replacement of primary prevention ICDs at 2 tertiary Veterans Affairs Medical Centers. Indications for continued ICD therapy at the time of generator replacement included a left ventricular ejection fraction (LVEF) ≤35% or receipt of appropriate device therapy. RESULTS In our cohort of 231 patients, 59 (26%) no longer met guideline-driven indications for an ICD at the time of generator replacement. An additional 79 patients (34%) had not received any appropriate ICD therapies and had not undergone reassessment of their LVEF. Patients with an initial LVEF of 30% to 35% were less likely to meet indications for ICD therapy at the time of replacement (odds ratio: 0.52; 95% confidence interval: 0.30 to 0.88; p = 0.01). Patients without ICD indications subsequently received appropriate ICD therapies at a significantly lower rate than patients with indications (2.8% vs. 10.7% annually, p < 0.001). If ICD generator explantations were performed instead of replacements in the patients without ICD indications, the cost savings would be

Adherence to thresholds: overdiagnosis of left ventricular noncompaction cardiomyopathy.

1.6 million. CONCLUSIONS Approximately 25% of patients who receive primary prevention ICDs may no longer meet guideline indications for ICD use at the time of generator replacement, and these patients receive subsequent ICD therapies at a significantly lower rate.

Cardiac Stress Test Trends Among US Patients Younger Than 65 Years, 2005-2012

Thresholds derived from quantification in imaging are increasingly used to define disease. This derivation is not an exact science. When one uses a threshold to define a disease, one does not clearly demarcate disease from normality because the threshold includes overlapping spectra of mild disease and normality. Thus, use of the threshold will mislabel normal individuals with disease. In this perspective, we will describe how the threshold has been derived for left ventricular noncompaction cardiomyopathy, the statistical biases in the design of studies used to derive the threshold, and the dangers of overdiagnosis when the threshold is used to rule out left ventricular noncompaction cardiomyopathy.

OverdiagnosisAdherence to Thresholds: Overdiagnosis of Left Ventricular Noncompaction Cardiomyopathy

Importance After a period of rapid growth, use of cardiac stress testing has recently decreased among Medicare beneficiaries and in a large integrated health system. However, it is not known whether declines in cardiac stress testing are universal or are confined to certain populations. Objective To determine trends in rates of cardiac stress testing among a large and diverse cohort of commercially insured patients. Design, Setting, and Participants A serial cross-sectional study with time trends was conducted using administrative claims from all members aged 25 to 64 years belonging to a large, national managed care company from January 1, 2005, to December 31, 2012. Linear trends in rates were determined using negative binomial regression models with procedure count as the dependent variable, calendar quarter as the key independent variable, and the size of the population as a logged offset term. Data analysis was performed from January 1, 2005, to December 31, 2012. Main Outcomes and Measures Age- and sex-adjusted rates of cardiac stress tests per calendar quarter (reported as number of tests per 100 000 person-years). Results A total of 2 085 591 cardiac stress tests were performed among 32 921 838 persons (mean [SD] age, 43.2 [10.9] years; 16 625 528 women [50.5%] and 16 296 310 [49.5%] men; 7 604 945 nonwhite [23.1%]). There was a 3.0% increase in rates of cardiac stress testing from 2005 (3486 tests; 95% CI, 3458-3514) to 2012 (3589 tests; 95% CI, 3559-3619; P = .01 for linear trend). Use of nuclear single-photon emission computed tomography decreased by 14.9% from 2005 (1907 tests; 95% CI, 1888-1926) to 2012 (1623 tests; 95% CI, 1603-1643; P = .03). Use of stress echocardiography increased by 27.8% from 2005 (709 tests; 95% CI, 697-721) to 2012 (906 tests; 95% CI, 894 to 920; P < .001). Use of exercise electrocardiography increased by 12.5% from 2005 (861 tests; 95% CI, 847-873) to 2012 (969 tests; 95% CI, 953-985; P < .001). Use of other stress testing modalities increased 65.5% from 2006 (55 tests; 95% CI, 51-59) to 2012 (91 tests; 95% CI, 87-95; P < .001). For individuals aged 25 to 34 years, rates of cardiac stress testing increased 59.1% from 2005 (543 tests; 95% CI, 532-554) to 2012 (864 tests; 95% CI, 852-876; P < .001). For individuals aged 55 to 64 years, rates of cardiac stress testing decreased by 12.3% from 2005 (7894 tests; 95% CI, 7820-7968) to 2012 (6923 tests; 95% CI, 6853-6993; P < .001). Conclusions and Relevance In contrast to declines in the use of cardiac stress testing in some health care systems, we observed a small increase in its use among a nationally representative cohort of commercially insured patients. Our findings suggest that observed trends in the use of cardiac stress testing may have been driven more by unique characteristics of populations and health systems than national efforts to reduce the overuse of testing.

Con: Patient's desire for termination of destination LVAD therapy should be respected.

Thresholds derived from quantification in imaging are increasingly used to define disease. This derivation is not an exact science. When one uses a threshold to define a disease, one does not clearly demarcate disease from normality because the threshold includes overlapping spectra of mild disease and normality. Thus, use of the threshold will mislabel normal individuals with disease. In this perspective, we will describe how the threshold has been derived for left ventricular noncompaction cardiomyopathy, the statistical biases in the design of studies used to derive the threshold, and the dangers of overdiagnosis when the threshold is used to rule out left ventricular noncompaction cardiomyopathy.

Clinical Outcomes After Cardiac Stress Testing Among US Patients Younger Than 65 Years

ATIENT AUTONOMY is a fundamental principle of the medical decision-making process. Any competent patient who makes a rational decision to discontinue any form of medical or surgical therapy should be allowed to do so. The treating physician has a responsibility to make sure the patient understands the likely outcomes when medical therapy is withdrawn, but the decision to withdraw ultimately lies with the patient. A competent patient best understands his or her values, and the paradigm of shared decision-making recognizes the need to respect autonomy based on this principle. Principles of informed consent and patient autonomy have been upheld in American law for decades. In 1914, in a ruling on a case in which a patient was subjected to an operation without giving consent, Justice Benjamin Cardozo wrote, “every human being of adult years and sound mind has a right to determine what shall be done with his own body.” 1 In 1990, the U.S. Congress passed the Patient Self-Determination Act, which required health care institutions to give patients written notice of their healthcare rights. 2 All patients were expressly given the right to facilitate their own healthcare decisions as well as the right to accept or refuse medical treatment. There is no conceivable situation in which a patient who has a destination LVAD should be denied these fundamental rights. If patients decide that their quality of life after implantation of an LVAD is worse than what they reasonably expected to have and that therefore they would like the LVAD to be removed, that decision should be respected. Decisions to withhold or withdraw medical therapies due to low quality of life are made every day in many situations throughout all fields of healthcare. The withdrawal of ventilatory support in a patient with refractory septic shock in a critical care unit, the disabling of an implantable cardioverter-defibrillator in a patient with advanced congestive heart failure in an outpatient cardiology clinic, or the discontinuation of cancer chemotherapy due to side effects are all reasonable in the right clinical situation if consistent with the patient’s goals. It should be no different for a patient who at one time chooses to be the recipient of a destination LVAD but thereafter changes his or her mind based on changing circumstances. A patient’s goals and values frequently change during the course of their medical treatment, especially with life-altering therapies such as left ventricular assist devices. In any scenario in which a patient expresses desire to withdraw medical therapy, these fundamental questions must be asked: What is the goal of the therapy? What is the likely outcome of the therapy? Are these goals and outcomes consistent with the patient’s values and goals? From a clinician’s perspective, the discussion with the patient may be quite different if the goals are palliation and symptom improvement versus simply living longer. Care also must be taken to make sure the patient understands, in a very specific way, what reasonably can be expected to happen once that therapy is discontinued. At the same time, however, the clinician should not be allowed to continually question a patient’s values and goals in an attempt to “break them down.” A patient who has made a reasoned decision must not be subjected to badgering by a physician. Clinicians must be cognizant of their own interests, which might compete with patients’ values and goals. Surgeons may be concerned that a poor outcome might reflect on their record, whether in formal reporting or simply in the eyes of referring physicians. Clinicians may consider withdrawal to be a failure on their part, or hold certain religious or cultural beliefs about withdrawal of therapies. However, the standard of care in American medicine is patient autonomy, and even in a patient who lacks decision-making capacity, substituted judgment takes precedence over what clinicians may perceive to be a patient’s best interest. The seminal REMATCH trial showed that patients with advanced heart failure who were randomized to destination LVAD therapy lived longer and had a better quality of life than those randomized to standard medical therapy. 3 Data from more recent studies and the recent INTERMACS report continue to show success with DT LVAD therapy in improving quality of life. 4,5 However, these same studies showed that a significant number of patients suffer major complications such as stroke, significant bleeding, permanent renal failure, and infection. Device thrombosis, infection, and failure often necessitate another operation for device replacement. Patients who experience a serious complication or device malfunction that leads to decreased quality of life should have the right to discontinue their LVAD if they so choose. In most cases, LVAD discontinuation involves deactivation of the device usually followed shortly by death (except in cases of ventricular recovery). LVAD deactivation is, therefore, a terminal event, to be accompanied by appropriate sedation, and can be similar to discontinuation of mechanical ventilation. Furthermore, as LVAD technology improves and becomes more widely disseminated, elderly patients and those with more comorbidities are increasingly likely to become LVAD candidates. Many of these patients will live long enough to develop other diseases such as cancer and dementia. If a patient’s quality of life suffers from a new disease unrelated to their LVAD, they should have the same opportunities as others

National Trends of Hospital Performance in Acute Myocardial Infarction Care: Department of Veterans Affairs, 2011–2014

Background Scientific statements have championed the measurement of clinical outcomes after cardiac stress testing to better define their value. Using contemporary national data, we sought to describe the characteristics of patients who experience outcomes after stress testing. Methods and Results Using administrative claims from a large national private insurer, we conducted an observational cohort study of patients without cardiovascular disease aged 25 to 64 years who underwent stress testing from 2006 to 2011 and had at least 1 year of membership in the insurance company before and after testing. We used Kaplan–Meier time‐to‐event analyses to determine rates of acute myocardial infarction (AMI), elective coronary revascularization, and coronary angiography without revascularization in the year following testing. We used logistic regression to determine factors associated with outcomes, and stratified the cohort into quintiles based on likelihood of experiencing AMI and/or revascularization to describe the characteristics of patients at highest and lowest risk. Among 553 027 patients who underwent stress testing (mean age 50 years, 49% women, 73% white), 0.8% were hospitalized for AMI, 1.8% underwent elective coronary revascularization, and 2.5% underwent coronary angiography without revascularization within 1 year. Patients who were older, male, and white were more likely to undergo subsequent revascularization. Patients in the lowest likelihood quintile were young (mean age 40 years), frequently women (84.7%), had a low incidence of coexisting conditions (5.2% with diabetes mellitus), and had a 0.5% rate of AMI and/or revascularization. Conclusions The proportion of US patients younger than 65 who had AMI and/or coronary revascularization after stress testing was low. Assessing risk of subsequent outcomes may be useful in improving patient referrals for stress testing.

Reply: Ejection Fraction May Improve But the Scar Still Exists! The Risk May Be Lower But Not Zero

Rates of mortality and readmission, both within 30 days of an admission with an acute myocardial infarction (AMI), are key measures of hospital performance. A recent report demonstrated that Veterans Administration (VA) hospitals had lower AMI mortality but higher readmission rates at 30 days compared with Medicare fee for service hospitals from 2010 to 2013.1 Although this information provides an overall assessment of the quality of care provided, it is also important to understand facility-level and temporal variations of these performance metrics to inform ongoing quality improvement efforts. Accordingly, we sought to characterize contemporary facility-level variations (ie, variation across hospitals not explained by variation in patient risk) in 30-day risk-standardized mortality rates (RSMRs) and 30-day risk-standardized readmission rates (RSRRs) across the VA, to identify underperforming or overperforming sites, and to assess temporal variations in these metrics. Data from the VA External Peer Review Program, in which trained staff abstracted clinical data from comprehensive chart reviews, were linked with the VA Corporate Data Warehouse—a source of inpatient and outpatient administrative data inclusive of vital status. Patients who were admitted to a VA hospital from January 1, 2011, to February 28, 2014, and assigned an International Classification of Diseases, Ninth Revision: Clinical Modification diagnosis code of 410.xx irrespective of age were included. Those transferred into the VA system were excluded. If a patient had multiple AMIs in the study time period, 1 AMI was randomly chosen for inclusion in the study. Outcome measures of interest were 30-day all-cause mortality and 30-day unplanned, all-cause readmission. The latter included VA and non-VA hospital readmissions for which the VA was billed. Hospitals with <20 AMI admissions during the study period were excluded. To assess outcome variation across hospitals, hospital-specific RSMRs and RSRRs were estimated using hierarchical log-binomial regression models to account for the clustering …

Eastern promises: Additive role of metabolic syndrome for thromboembolic risk stratification in Taiwanese atrial fibrillation patients.

We thank Dr. Pillarisetti and colleagues for their interest in our report [(1)][1]. However, we disagree with the conclusions they have drawn from additional analysis of our data. They argue that patients with primary prevention implantable cardioverter-defibrillators (ICDs) who experience no

Focused Cardiac Ultrasound in Place of Repeat Echocardiography: Reliability and Cost Implications

The key to prevention of stroke and other thromboembolic (TE) events in atrial fibrillation (AF) patients is effective risk stratification. Several schemes have been developed that use a combination of factors found to be associated with higher occurrence of TE events. Among the various risk stratification schemes, the CHADS2 (congestive heart failure, hypertension, ageZ75 years, diabetes, and prior history of stroke) scoring system is the most popular. Although the simplicity of this scoring system has resulted in its wide adoption, a major criticism has been its inability to consistently identify a truly low-risk group of AF patients. To address this deficit, the CHA2DS2-VASc scoring system was developed. 4 This scheme uses all components of the CHADS2 system but with greater emphasis on age and includes two additional factors: female sex and vascular disease. Thus, at the present time, using either CHADS2 or CHA2DS2-VASc scoring system, we have some uniformity in our approach to TE risk stratification for AF patients. Nevertheless, the discriminatory power of both these scoring systems is limited (C-statistic o0.7, which implies that the test accounts for a little more than half the attributable risk of events in the population tested). Models are typically considered reasonable when the C-statistic is 40.7 and strong when C40.8. The less than ideal performance of these two scoring systems implies that other important predictive factors of TE risk remain undefined. In pursuit of this hypothesis, in this issue of HeartRhythm Tsai et al report their observations on the role of metabolic syndrome (MS) for TE risk stratification in Taiwanese AF patients. The study population comprised 721 subjects diagnosed with AF after 1998 and subsequently followed through 2012. Baseline evaluation and investigative workup for all patients were used to derive their CHADS2 and CHA2DS2-VASc scores as well as an assessment of MS. The latter was based on conventional criteria that included obesity, abnormal lipids (triglycerides and high-density lipoprotein–C), raised blood pressure, and abnormal fasting glucose. The objective of the study was to investigate whether AF patients with MS carry an increased risk of TE events. The investigators also