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1.
Europace ; 25(5)2023 05 19.
Article in English | MEDLINE | ID: mdl-37208301

ABSTRACT

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.


Subject(s)
Monitoring, Physiologic , Telemetry , Humans
2.
Am Heart J ; 254: 102-111, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36007567

ABSTRACT

BACKGROUND: Clinical events committee (CEC) evaluation is the standard approach for end point adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported end points without further confirmation, which may preclude use for regulatory oversight. METHODS: We developed a novel automated adjudication algorithm (AAA) for end point adjudication in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry using an iterative process using CEC adjudication as the "gold standard." A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated. RESULTS: A total of 92 in-hospital and 127 post-discharge end points were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was >90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was >80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach, <1% of site reported end points require CEC adjudication. Agreement remained very good during the period after algorithm derivation. CONCLUSIONS: An AAA-guided approach for end point adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Ischemic Attack, Transient , Stroke , Humans , Aftercare , Patient Discharge , Ischemic Attack, Transient/complications , Registries , Stroke/prevention & control , Stroke/complications , Treatment Outcome , Atrial Fibrillation/complications
3.
Am Heart J ; 240: 58-62, 2021 10.
Article in English | MEDLINE | ID: mdl-34033802

ABSTRACT

Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Stroke/prevention & control , Administration, Oral , Aged , Dabigatran/therapeutic use , Female , Humans , Male , Practice Patterns, Physicians' , Pyrazoles/therapeutic use , Pyridines/therapeutic use , Pyridones/therapeutic use , Registries , Risk Factors , Rivaroxaban/therapeutic use , Thiazoles/therapeutic use , Warfarin/therapeutic use
4.
Am Heart J ; 226: 161-173, 2020 08.
Article in English | MEDLINE | ID: mdl-32599257

ABSTRACT

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.


Subject(s)
Decision Making, Shared , Decision Support Techniques , Multicenter Studies as Topic/methods , Randomized Controlled Trials as Topic/methods , Defibrillators, Implantable , Humans , Medicare , Pilot Projects , United States
5.
J Cardiovasc Electrophysiol ; 30(2): 212-220, 2019 02.
Article in English | MEDLINE | ID: mdl-30575180

ABSTRACT

BACKGROUND: Individual risk factors of intraprocedural cardiac injury (cardiac perforation and tamponade) during implantable cardioverter defibrillator (ICD) placement have been documented. However, the prognostic impact of their coexistence has not been explored. OBJECTIVE: To develop a risk score model to identify patients at risk for intraprocedural cardiac injury. METHODS: We identified 438 679 patients from National Cardiovascular Data Registry (NCDR)-ICD who underwent de novo ICD implantation between 2010 and 2015, split randomly into a derivation cohort (n = 220 000) and a validation cohort (n = 218 679). The generalized estimating equations (GEEs) analysis with quasilikelihood under the independence model criterion goodness-of-fit statistics were used to identify the predictors of intraprocedural cardiac injury and a risk scoring model was developed. Model discrimination was assessed by receiver-operator characteristic curve and C-statistic. RESULTS: The risk of intraprocedural cardiac injury in the overall cohort was 0.13%. GEE analysis yielded seven variables (points in parentheses) that were strongly associated with intraprocedural cardiac injury: age, greater than 75 years (1), female gender (1), body mass index, less than 18.5 kg/m 2 (1), hypertension (1), chronic lung disease (1), left bundle branch block (1), and continued warfarin use (1). Only prior history of coronary artery bypass grafting (CABG) (-1) was associated with reduced risk. A risk scoring system was developed that had good discrimination with a C-statistic of 0.72. The risk of intraprocedural cardiac injury increased with the increase in risk score from low risk (0.03%) to high risk (1.37%). CONCLUSION: A practical risk score model can stratify patients into high- and low-risk groups for cardiac perforation or tamponade before undergoing ICD implantation.


Subject(s)
Cardiac Tamponade/epidemiology , Decision Support Techniques , Defibrillators, Implantable , Electric Countershock/adverse effects , Electric Countershock/instrumentation , Heart Injuries/epidemiology , Aged , Cardiac Tamponade/diagnostic imaging , Clinical Decision-Making , Female , Heart Injuries/diagnostic imaging , Humans , Incidence , Male , Middle Aged , Patient Selection , Predictive Value of Tests , Registries , Reproducibility of Results , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States/epidemiology
6.
J Cardiovasc Electrophysiol ; 30(10): 1939-1948, 2019 10.
Article in English | MEDLINE | ID: mdl-31257683

ABSTRACT

INTRODUCTION: While cardiac sarcoidosis (CS) carries a risk of ventricular arrhythmias (VAs) and sudden cardiac death (SCD), risk stratification of patients with CS and preserved left ventricular/right ventricular (LV/RV) systolic function remains challenging. We sought to evaluate the role of electrophysiologic testing and programmed electrical stimulation of the ventricle (EPS) in patients with suspected CS with preserved ventricular function. METHODS: One hundred twenty consecutive patients with biopsy-proven extracardiac sarcoidosis and preserved LV/RV systolic function underwent EPS. All patients had either probable CS defined by an abnormal cardiac positron emission tomography or cardiac magnetic resonance imaging, or possible CS with normal advanced imaging but abnormal echocardiogram (ECG), SAECG, Holter, or clinical factors. Patients were followed for 4.5 ± 2.6 years for SCD and VAs. RESULTS: Seven of 120 patients (6%) had inducible ventricular tachycardia (VT) with EPS and received an implantable cardioverter defibrillator (ICD). Three patients (43%) with positive EPS later had ICD therapies for VAs. Kaplan-Meier analysis stratified by EPS demonstrated a significant difference in freedom from VAs and SCD (P = 0.009), though this finding was driven entirely by patients within the cohort with probable CS (P = 0.018, n = 69). One patient with possible CS and negative EPS had unrecognized progression of the disease and unexplained death with evidence of CS at autopsy. CONCLUSIONS: EPS is useful in the risk stratification of patients with probable CS with preserved LV and RV function. A positive EPS was associated with VAs. While a negative EPS appeared to confer low risk, close follow-up is needed as EPS cannot predict fatal VAs related to new cardiac involvement or disease progression.


Subject(s)
Action Potentials , Arrhythmias, Cardiac/diagnosis , Cardiomyopathies/diagnosis , Electrocardiography , Electrophysiologic Techniques, Cardiac , Heart Rate , Sarcoidosis/diagnosis , Ventricular Function, Left , Ventricular Function, Right , Aged , Arrhythmias, Cardiac/mortality , Arrhythmias, Cardiac/physiopathology , Arrhythmias, Cardiac/therapy , Cardiomyopathies/mortality , Cardiomyopathies/physiopathology , Cardiomyopathies/therapy , Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Disease Progression , Electric Countershock/instrumentation , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Prognosis , Retrospective Studies , Risk Assessment , Risk Factors , Sarcoidosis/mortality , Sarcoidosis/physiopathology , Sarcoidosis/therapy , Stroke Volume , Systole , Time Factors
7.
Pacing Clin Electrophysiol ; 42(4): 458-463, 2019 Apr.
Article in English | MEDLINE | ID: mdl-30779183

ABSTRACT

BACKGROUND: Despite improvement in catheter ablation for atrial fibrillation (AF), ability to recognize and prevent esophageal injury remains challenging. We hypothesized that esophageal course may impact esophageal heating, as measured through ablation, and thereby, risk of injury. METHODS: We evaluated all patients undergoing first-time AF ablation with preprocedural computed tomography (CT) imaging from 2014 to 2016 at our institution, focusing on esophageal position at the left atrial (LA)/pulmonary vein junction. Esophageal luminal temperatures (ELTs) were analyzed by esophageal course. In exploratory work by investigation of published reports of atrioesophageal fistula (AEF), we evaluated for a relationship between esophageal course and risk of AEF. RESULTS: Of 68 patients, 48.5% had midline, 36.8% leftward, and 14.7% rightward esophageal positions. Of 20 patients (29% of cohort) with esophageal confinement-defined as a midline or leftward position relative to the LA, vertebrae, and aorta, with luminal distortion-14 had leftward position. No significant differences in patient or procedure characteristics were noted between confinement and nonconfinement cohorts. The average peak ELT was significantly higher in those with confinement (36.9°C vs 36.2°C, P < 0.05) and confinement with a left-sided esophagus (37.1°C vs 36.2°C, P < 0.05). There was a significant correlation between esophageal confinement and risk of AEF (odds ratio [OR]: 2.7, 95% confidence interval [CI]: 1.2-6.2, P < 0.01). CONCLUSION: Approximately one-third of patients undergoing AF ablation display leftward esophageal course along the ablation zone on preprocedure CT imaging, with a significant portion exhibiting esophageal confinement. In those with confinement, higher peak ELTs are noted with ablation. Esophageal confinement may be a risk factor for development of AEF.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Esophageal Fistula/etiology , Esophagus/diagnostic imaging , Esophagus/injuries , Heart Atria/injuries , Tomography, X-Ray Computed , Female , Hot Temperature , Humans , Male , Middle Aged
8.
Circulation ; 136(5): e123-e135, 2017 Aug 01.
Article in English | MEDLINE | ID: mdl-28280230

ABSTRACT

OBJECTIVES: To determine, using systematic review of the biomedical literature, whether pacing reduces risk of recurrent syncope and relevant clinical outcomes among adult patients with reflex-mediated syncope. METHODS: MEDLINE (through PubMed), EMBASE, and the Cochrane Central Register of Controlled Trials (through October 7, 2015) were searched for randomized trials and observational studies examining pacing and syncope, and the bibliographies of known systematic reviews were also examined. Studies were rejected for poor-quality study methods and for the lack of the population, intervention, comparator, or outcome(s) of interest. RESULTS: Of 3188 citations reviewed, 10 studies met the inclusion criteria for systematic review, including a total of 676 patients. These included 9 randomized trials and 1 observational study. Of the 10 studies, 4 addressed patients with carotid sinus hypersensitivity, and the remaining 6 addressed vasovagal syncope. Among the 6 open-label (unblinded) studies, we found that pacing was associated with a 70% reduction in recurrent syncope (relative risk [RR]: 0.30; 95% confidence interval [CI]: 0.15-0.60). When the 2 analyzable studies with double-blinded methodology were considered separately, there was no clear benefit (RR: 0.73; 95% CI: 0.25-2.1), but confidence intervals were wide. The strongest evidence was from the randomized, double-blinded ISSUE-3 (Third International Study on Syncope of Uncertain Etiology) trial, which demonstrated a benefit of pacing among patients with recurrent syncope and asystole documented by implantable loop recorder. CONCLUSIONS: There are limited data with substantive evidence of outcome ascertainment bias, and only 2 studies with a double-blinded study design have been conducted. The evidence does not support the use of pacing for reflex-mediated syncope beyond patients with recurrent vasovagal syncope and asystole documented by implantable loop recorder.


Subject(s)
Reflex , Syncope/therapy , American Heart Association , Humans , Pacemaker, Artificial , Practice Guidelines as Topic , Syncope/pathology , Syncope, Vasovagal/pathology , Syncope, Vasovagal/therapy , United States
9.
J Cardiovasc Electrophysiol ; 29(10): 1403-1412, 2018 10.
Article in English | MEDLINE | ID: mdl-30033528

ABSTRACT

INTRODUCTION: Multiple ablations are often necessary to manage ventricular arrhythmias (VAs) in nonischemic cardiomyopathy (NICM) patients. We assessed characteristics and outcomes and role of adjunctive, nonstandard ablation in repeat VA ablation (RAbl) in NICM. METHODS AND RESULTS: Consecutive NICM patients undergoing RAbl were analyzed, with characteristics of the last VA ablations compared between those undergoing 1 versus multiple-repeat ablations (1-RAbl vs. >1RAbl), and between those with or without midmyocardial substrate (MMS). VA-free survival was compared. Eighty-eight patients underwent 124 RAbl, 26 with > 1RAbl, and 26 with MMS. 1-RAbl and > 1-RAbl groups were similar in age (57 ± 16 vs. 57 ± 17 years; P = 0.92), males (76% vs. 69%; P = 0.60), LVEF (40 ± 17% vs. 40 ± 18%; P = 0.96), and amiodarone use (31% vs. 46%, P = 0.22). One-year VA freedom between 1-RAbl vs. > 1RAbl was similar (82% vs. 80%; P = 0.81); adjunctive ablation was utilized more in >1RAbl (31% vs. 11%, P = 0.02), and complication rates were higher (27% vs. 7%, P = 0.01), most due to septal substrate and anticipated heart block. >1-RAbl patients had more MMS (62% vs. 16%, P < 0.01). Although MMS was associated with worse VA-free survival after 1-RAbl (43% vs. 69%, P = 0.01), when >1RAbl was performed, more often with nonstandard ablation, VA-free survival was comparable to non-MMS patients (85% vs. 81%; P = 0.69). More RAbls were required in MMS versus non-MMS patients (2.00 ± 0.98 vs. 1.16 ± 0.37; P < 0.001). CONCLUSION: For NICM patients with recurrent, refractory VAs despite previous ablation, effective arrhythmia control can safely be achieved with subsequent ablation, although >1 repeat procedure with adjunctive ablation is often required, especially with MMS.


Subject(s)
Cardiomyopathies/complications , Catheter Ablation , Heart Ventricles/surgery , Tachycardia, Ventricular/surgery , Action Potentials , Adult , Aged , Anti-Arrhythmia Agents/therapeutic use , Cardiomyopathies/diagnosis , Catheter Ablation/adverse effects , Female , Heart Rate , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Progression-Free Survival , Reoperation , Risk Factors , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/etiology , Tachycardia, Ventricular/physiopathology , Time Factors
11.
BMC Cardiovasc Disord ; 17(1): 236, 2017 09 02.
Article in English | MEDLINE | ID: mdl-28865440

ABSTRACT

BACKGROUND: The direct oral anticoagulants (DOACs) reduce the risk of stroke in moderate to high-risk patients with non-valvular atrial fibrillation (AF). Yet, concerns remain regarding its routine use in real world practice. We sought to describe adherence patterns and the association between adherence and outcomes to the DOACs among outpatients with AF. METHODS: We performed a retrospective cohort study of patients in the VA Healthcare System who initiated pharmacotherapy with dabigatran, rivaroxaban, or apixaban between November 2010 and January 2015 for non-valvular AF with CHA2DS2-VASc score ≥ 2. Adherence was determined using pharmacy refill data and estimated by the proportion of days covered (PDC) over the first year of therapy. Clinical outcomes, including all-cause mortality and stroke, were measured at 6 months and used to assess measures of adherence for each DOAC. RESULTS: A total of 2882 patients were included. Most were prescribed dabigatran (72.7%), compared with rivaroxaban (19.8%) or apixaban (7.5%). The mean PDC was 0.84 ± 0.20 for dabigatran, 0.86 ± 0.18 for rivaroxaban, and 0.89 ± 0.14 for apixaban (p < 0.01). The proportion of non-adherent patients, PDC <0.80, was 27.6% for all and varied according DOAC. Lower adherence to dabigatran was associated with higher risk of mortality and stroke (HR 1.07; 1.03-1.12 per 0.10 decline in PDC). CONCLUSIONS: In a real-world VA population being prescribed anticoagulation for AF, more than one quarter had sub-optimal adherence. Lower adherence was associated with a higher risk of mortality and stroke. Efforts identifying non-adherent patients, and targeted adherence interventions are needed to improve outcomes.


Subject(s)
Antithrombins/administration & dosage , Atrial Fibrillation/drug therapy , Blood Coagulation/drug effects , Dabigatran/administration & dosage , Factor Xa Inhibitors/administration & dosage , Medication Adherence , Pyrazoles/administration & dosage , Pyridones/administration & dosage , Rivaroxaban/administration & dosage , Stroke/prevention & control , United States Department of Veterans Affairs , Veterans Health , Administration, Oral , Aged , Aged, 80 and over , Antithrombins/adverse effects , Atrial Fibrillation/blood , Atrial Fibrillation/complications , Atrial Fibrillation/mortality , Dabigatran/adverse effects , Drug Prescriptions , Factor Xa Inhibitors/adverse effects , Female , Humans , Linear Models , Male , Middle Aged , Odds Ratio , Proportional Hazards Models , Pyrazoles/adverse effects , Pyridones/adverse effects , Retrospective Studies , Risk Factors , Rivaroxaban/adverse effects , Stroke/blood , Stroke/etiology , Stroke/mortality , Time Factors , Treatment Outcome , United States
12.
Am J Respir Crit Care Med ; 193(7): 783-91, 2016 Apr 01.
Article in English | MEDLINE | ID: mdl-26595380

ABSTRACT

RATIONALE: Although research supports a sleep-disordered breathing and atrial fibrillation association, prospective data examining sleep-disordered breathing predicting incident atrial fibrillation are lacking. OBJECTIVES: To investigate sleep-disordered breathing indices as predictors of incident atrial fibrillation. METHODS: A cohort (n = 843) of ambulatory older men without prevalent atrial fibrillation was assessed for baseline sleep indices: apnea-hypopnea index, central sleep apnea (central apnea index, ≥5 vs. <5), central sleep apnea or Cheyne-Stokes respiration, obstructive apnea-hypopnea index, and percentage of sleep time with less than 90% oxygen saturation. Incident clinically symptomatic adjudicated or self-reported atrial fibrillation outcome was ascertained (mean follow-up, 6.5 ± 0.7 yr). We used logistic regression models adjusted for age, race, body mass index, cardiopulmonary disease, alcohol use, pacemaker, cholesterol, cardiac medications, and alternate apnea type for obstructive and central apnea. Age interaction terms and median age-stratified analyses were performed. MEASUREMENTS AND MAIN RESULTS: Central sleep apnea (odds ratio [OR], 2.58; 95% confidence interval [CI], 1.18-5.66) and Cheyne-Stokes respiration with central sleep apnea (OR, 2.27; 95% CI, 1.13-4.56), but not obstructive apnea or hypoxemia, predicted incident atrial fibrillation. Central apnea, Cheyne-Stokes respiration, and sleep-disordered breathing-age interaction terms were significant (P < 0.05). Unlike the case with younger participants, among participants aged 76 years or older (albeit with small atrial fibrillation counts), atrial fibrillation was related to central apnea (OR, 9.97; 95% CI, 2.72-36.50), Cheyne-Stokes respiration with central apnea (OR, 6.31; 95% CI, 1.94-20.51), and apnea-hypopnea index (OR, 1.22; 95% CI, 1.08-1.39 [per 5-unit increase]). CONCLUSIONS: In older men, central apnea and Cheyne-Stokes respiration predicted increased atrial fibrillation risk, with findings being strongest in older participants in whom overall sleep-disordered breathing also increased atrial fibrillation risk.


Subject(s)
Atrial Fibrillation/epidemiology , Cheyne-Stokes Respiration/epidemiology , Sleep Apnea, Central/epidemiology , Aged , Comorbidity , Humans , Logistic Models , Male , Multivariate Analysis , Prospective Studies , Risk Assessment , United States
15.
Circulation ; 130(10): 845-53, 2014 Sep 02.
Article in English | MEDLINE | ID: mdl-25095884

ABSTRACT

BACKGROUND: Contemporary patterns of use and outcomes of implantable cardioverter-defibrillators (ICDs) in community practice settings are not well characterized. We assessed temporal trends in patient characteristics and outcomes among older patients undergoing primary prevention ICD therapy in US hospitals between 2006 and 2010. METHODS AND RESULTS: Using the National Cardiovascular Data Registry's ICD Registry, we identified Medicare fee-for-service beneficiaries aged ≥65 years and older with left ventricular ejection fraction ≤35% who underwent primary prevention ICD implantation, including those receiving concomitant cardiac resynchronization therapy between 2006 and 2010 and could be matched to Medicare claims. Outcomes were mortality and hospitalization (all-cause and heart failure) at 180 days, and device-related complications. We used multivariable hierarchical logistic regression to assess temporal trends in outcomes accounting for changes in patient, physician, and hospital characteristics. The cohort included 117 100 patients. Between 2006 and 2010, only modest changes in patient characteristics were noted. Fewer single lead devices and more cardiac resynchronization therapy devices were used over time. Between 2006 and 2010, there were significant improvements in all outcomes, including 6-month all cause mortality (7.1% in 2006, 6.5% 2010; adjusted odds ratio, 0.88; 95% confidence interval, 0.82-0.95), 6-month rehospitalization (36.3% in 2006, 33.7% in 2010; adjusted odds ratio, 0.87; 95% confidence interval, 0.83-0.91), and device-related complications (5.8% in 2006, 4.8% in 2010; adjusted odds ratio, 0.80; 95% confidence interval, 0.74-0.88). CONCLUSIONS: The clinical characteristics of this national population of Medicare patients undergoing primary prevention ICD implantation were stable between 2006 and 2010. Simultaneous improvements in outcomes suggest meaningful advances in the care for this patient population.


Subject(s)
Defibrillators, Implantable , Fee-for-Service Plans/trends , Heart Failure/therapy , Medicare/trends , Primary Prevention/trends , Registries , Aged , Aged, 80 and over , Cohort Studies , Female , Heart Failure/mortality , Heart Failure/physiopathology , Humans , Logistic Models , Male , Patient Readmission/statistics & numerical data , Retrospective Studies , Stroke Volume/physiology , Survival Rate , Treatment Outcome , United States/epidemiology
18.
Am Heart J ; 170(2): 281-289.e2, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26299225

ABSTRACT

OBJECTIVE: We sought to determine survival for patients with heart failure after an implantation of an implantable cardioverter defibrillator (ICD) for primary prevention in the United States and to develop a simple model that would predict mortality risk. BACKGROUND: Clinical trials have found that patients with heart failure with a 1-year mortality risk near 20% may not benefit from an ICD. METHODS: We identified patients from the ICD Registry of the National Cardiovascular Disease Registries who underwent ICD implantation for primary prevention from 2007 to 2009. Two risk scores for mortality were developed in 2 cohorts: one limited to those with a B-type natriuretic peptide (BNP) value and a second for all patients. The scores were obtained from derivation datasets and tested in a validation sets using logistic regression models and classification and regression trees. RESULTS: In a primary prevention population with BNP available (18,725) the 6 variables most predictive of 1-year mortality were age ≥75, BNP ≥700 pg/mL, chronic lung disease, dialysis, blood urea nitrogen ≥30 mg/dL, and systolic blood pressure <120 mmHg. Patients with zero risk factors had a 3.3% one-year mortality compared to a 66.7% one-year mortality for those with all 6 risk factors. Those with ≥3 risk factors (24.0% of the population) had a 25.8% one-year mortality. A second score using a larger cohort that did not consider BNP identified similar risk factors. CONCLUSIONS: A simple validated risk score can identify patients at high and low risk for death within a year after ICD placement. A large fraction of those currently implanted with an ICD in the United States have a high 1-year mortality and may not benefit from ICD therapy.


Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Heart Failure/therapy , Primary Prevention , Registries , Risk Assessment/methods , Aged , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/etiology , Female , Follow-Up Studies , Heart Failure/complications , Heart Failure/mortality , Humans , Male , Predictive Value of Tests , Retrospective Studies , Risk Factors , Survival Rate/trends , Time Factors , United States/epidemiology
19.
Am Heart J ; 169(1): 45-52.e3, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25497247

ABSTRACT

BACKGROUND: Implantable cardioverter-defibrillator (ICD) procedures performed later in the day and on weekends/holidays may be associated with adverse events due to a variety of factors including operator fatigue, handoffs, reduced staffing, and limited resource availability. We sought to determine whether patients implanted with ICDs in the afternoon/evening and on weekends/holidays are at increased risk for adverse events. METHODS: We studied 148,004 first-time ICD recipients in the National Cardiovascular Data Registry-ICD Registry implanted between April 2010 and March 2012. Using hierarchical multivariable logistic regression adjusting for patient, implanting physician, and hospital characteristics, we examined the association between both ICD implant start time and day of week with any complication, a prolonged hospital stay, and mortality. RESULTS: Most ICD implants (52.6%; n = 77,853) were performed in the morning (6 am-12 pm) and during the regular workweek (97.5%; n = 144,266). After multivariable adjustment, ICD recipients implanted in the afternoon (12 pm-5 pm)/evening (5 pm-6 am) compared with the morning experienced a greater odds of any complication (odds ratio [OR] 1.08; 95% CI 1.01-1.15; P = .0168), hospital stay >1 day (OR 1.29; 95% CI 1.25-1.33; P < .0001) but not inhospital death (OR 1.06; 95% CI 0.88-1.27; P = .5322). Implantable cardioverter-defibrillator recipients implanted on weekend/holidays compared with the mid-workweek also experienced a significantly greater odds of hospital stay >1 day (OR 1.40; 95% CI 1.29-1.53; P < .0001), no statistically significant differences in total complications (OR 1.14; 95% CI 0.96-1.36; P = .1371), and a trend toward more inhospital death (OR 1.52; 95% CI 0.98-2.38; P = .0642). CONCLUSIONS: In a large, real-world population, ICD recipients implanted in the afternoon/evening and on weekends/holidays more often experienced adverse events, particularly prolonged hospital stays.


Subject(s)
Defibrillators, Implantable/adverse effects , Postoperative Complications/epidemiology , Prosthesis Implantation/adverse effects , Aged , Hospital Mortality , Humans , Length of Stay , Logistic Models , Male , Middle Aged , Prosthesis Implantation/mortality , Registries , Risk Assessment , Time
20.
Am Heart J ; 168(3): 381-390.e6, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25173551

ABSTRACT

BACKGROUND: Posttraumatic stress disorder (PTSD) is prevalent in the general population and US veterans in particular and is associated with an increased risk of developing coronary artery disease (CAD). We compared the patient characteristics and postprocedural outcomes of veterans with and without PTSD undergoing coronary angiography. METHODS: This is a multicenter observational study of patients who underwent coronary angiography in Veterans Affairs hospitals nationally from October 2007 to September 2011. We described patient characteristics at angiography, angiographic results, and after coronary angiography, we compared risk-adjusted 1-year rates of all-cause mortality, myocardial infarction (MI), and revascularization by the presence or absence of PTSD. RESULTS: Overall, of 116,488 patients undergoing angiography, 14,918 (12.8%) had PTSD. Compared with those without PTSD, patients with PTSD were younger (median age 61.9 vs 63.7; P < .001), had higher rates of cardiovascular risk factors, and were more likely to have had a prior MI (26.4% vs 24.7%; P < .001). Patients with PTSD were more likely to present for stable angina (22.4% vs 17.0%) or atypical chest pain (58.5% vs 48.6%) and less likely to have obstructive CAD identified at angiography (55.9% vs 62.2%; P < .001). After coronary angiography, PTSD was associated with lower unadjusted 1-year rates of MI (hazard ratio (HR), 0.86; 95% CI [0.75-1.00]; P = 0.04), revascularization (HR, 0.88; 95% CI [0.83-0.93]; P < .001), and all-cause mortality (HR, 0.66; 95% CI [0.60-0.71]; P < .001). After adjustment for cardiovascular risk, PTSD was no longer associated with 1-year rates of MI or revascularization but remained associated with lower 1-year all-cause mortality (HR, 0.91; 95% CI [0.84-0.99]; P = .03). Findings were similar after further adjustment for depression, anxiety, alcohol or substance use disorders, and frequency of outpatient follow-up. CONCLUSIONS: Among veterans undergoing coronary angiography in the Veterans Affairs, those with PTSD were more likely to present with elective indications and less likely to have obstructive CAD. After coronary angiography, PTSD was not associated with adverse 1-year outcomes of MI, revascularization, or all-cause mortality.


Subject(s)
Coronary Artery Disease/epidemiology , Coronary Artery Disease/therapy , Stress Disorders, Post-Traumatic/epidemiology , Veterans , Aged , Coronary Angiography , Coronary Artery Disease/psychology , Female , Humans , Male , Middle Aged , Prevalence , Risk Factors , Treatment Outcome , United States/epidemiology
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