Christine Tompkins

Dual Antiplatelet Therapy and Heparin “Bridging” Significantly Increase the Risk of Bleeding Complications After Pacemaker or Implantable Cardioverter-Defibrillator Device Implantation

OBJECTIVES This study was designed to assess the risk of significant bleeding complications in patients receiving antiplatelet or anticoagulation medications at the time of implantable cardioverter-defibrillator (ICD) device implantation. BACKGROUND Periprocedural management of antiplatelet or anticoagulation therapy at the time of device implantation remains controversial. METHODS We performed a retrospective chart review of bleeding complications in all patients undergoing ICD or pacemaker implantation from August 2004 to August 2007. Aspirin or clopidogrel use was defined as taken within 5 days of the procedure. A significant bleeding complication was defined as need for pocket exploration or blood transfusion; hematoma requiring pressure dressing or change in anticoagulation therapy; or prolonged hospitalization. RESULTS Of the 1,388 device implantations, 71 had bleeding complications (5.1%). Compared with controls not taking antiplatelet agents (n = 255), the combination of aspirin and clopidogrel (n = 139) significantly increased bleeding risk (7.2% vs. 1.6%; p = 0.004). In patients taking aspirin alone (n = 536), bleeding risk was marginally higher than it was for patients taking no antiplatelet agents (3.9% vs. 1.6%, p = 0.078). The use of periprocedural heparin (n = 154) markedly increased risk of bleeding when compared with holding warfarin until the international normalized ratio (INR) was normal (n = 258; 14.3% vs. 4.3%; p < 0.001) and compared with patients receiving no anticoagulation therapy (14.3% vs.1.6%; p < 0.0001). There was no statistical difference in bleeding risk between patients continued on warfarin with an INR > or =1.5 (n = 46) and patients who had warfarin withheld until the INR was normal (n = 258; 6.5% vs. 4.3%; p = 0.50). CONCLUSIONS Dual antiplatelet therapy and periprocedural heparin significantly increase the risk of bleeding complications at the time of pacemaker or ICD implantation.

The metabolic syndrome in women

The metabolic syndrome, an increasingly prevalent disorder, is known to significantly enhance the risk of developing cardiovascular disease and diabetes. The syndrome is defined by a constellation of cardiac risk factors that include obesity, atherogenic dyslipidemia, hypertension, and insulin resistance. There are several unique features of the metabolic syndrome in women. An insulin-resistant state associated with both polycystic ovarian syndrome and increased abdominal fat may contribute to the development of the metabolic syndrome and increase cardiovascular risk when present. Menopause heralds a decline in circulating estrogen levels, which may increase cardiovascular risk through effects on adiposity, lipid metabolism, and prothrombotic state. The key elements involved in managing the metabolic syndrome are dietary and lifestyle modification. Appropriate treatment may also include managing individual cardiac risk factors with the use of antihypertensive and lipid-modifying agents among others.

Continuation of warfarin during pacemaker or implantable cardioverter-defibrillator implantation: A randomized clinical trial

BACKGROUND Management of oral anticoagulation in patients undergoing pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) implantation remains controversial. Prior studies demonstrate that continuation of warfarin may be safer when compared with strategies requiring interruption and/or heparin bridging. Limited data from randomized trials exist. OBJECTIVE We conducted a randomized trial to determine whether warfarin continuation is superior to warfarin interruption during PPM or ICD implantation. METHODS Patients on oral anticoagulation referred for PPM or ICD implantation were randomized to warfarin continuation versus interruption. Patients randomized to warfarin interruption were further stratified into two groups based on their risk for thromboembolic events in the absence of warfarin. Moderate-risk patients were randomized to warfarin continuation versus warfarin interruption. High-risk patients were randomized to warfarin continuation versus warfarin interruption with heparin bridging. The primary combined outcome included thromboembolic events, anticoagulant-related complications, or any significant bleeding necessitating additional intervention or discontinuation of anticoagulation. RESULTS We studied 100 patients (average age 70.8 years, 21% female, mean body mass index 28.4) who underwent 64 ICD and 36 PPM implantations. Fifty patients were assigned to continue warfarin. The randomized groups were well matched. Among patients randomized to warfarin interruption, there were two pocket hematomas, one pericardial effusion, one transient ischemic attack, and one patient who developed heparin-induced thrombocytopenia. No events were noted among patients continuing warfarin (P = .056). CONCLUSIONS While the results were not statistically significant, there was a trend toward reduced complications in patients randomized to warfarin continuation. This strategy should be considered in patients undergoing PPM or ICD implantation.

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

Fred M. Kusumoto, MD, FHRS, FACC, Chair, Mark H. Schoenfeld, MD, FHRS, FACC, FAHA, CCDS, Vice-Chair, Bruce L. Wilkoff, MD, FHRS, CCDS, Vice-Chair, Charles I. Berul, MD, FHRS, Ulrika M. Birgersdotter-Green, MD, FHRS, Roger Carrillo, MD, MBA, FHRS, Yong-Mei Cha, MD, Jude Clancy, MD, Jean-Claude Deharo, MD, FESC, Kenneth A. Ellenbogen, MD, FHRS, Derek Exner, MD, MPH, FHRS, Ayman A. Hussein, MD, FACC, Charles Kennergren, MD, PhD, FETCS, FHRS, Andrew Krahn, MD, FRCPC, FHRS, Richard Lee, MD, MBA, Charles J. Love, MD, CCDS, FHRS, FACC, FAHA, Ruth A. Madden, MPH, RN, Hector Alfredo Mazzetti, MD, JoEllyn Carol Moore, MD, FACC, Jeffrey Parsonnet, MD, Kristen K. Patton, MD, Marc A. Rozner, PhD, MD, CCDS, Kimberly A. Selzman, MD, MPH, FHRS, FACC, Morio Shoda, MD, PhD, Komandoor Srivathsan, MD, Neil F. Strathmore, MBBS, FHRS, Charles D. Swerdlow, MD, FHRS, Christine Tompkins, MD, Oussama Wazni, MD, MBA

Impact of the right ventricular lead position on clinical outcome and on the incidence of ventricular tachyarrhythmias in patients with CRT-D

BACKGROUND Data on the impact of right ventricular (RV) lead location on clinical outcome and ventricular tachyarrhythmias in cardiac resynchronization therapy with defibrillator (CRT-D) patients are limited. OBJECTIVE To evaluate the impact of different RV lead locations on clinical outcome in CRT-D patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy trial. METHODS We investigated 742 of 1089 CRT-D patients (68%) with adjudicated RV lead location enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy trial to evaluate the impact of RV lead location on cardiac events. The primary end point was heart failure or death; secondary end points included ventricular tachycardia (VT), ventricular fibrillation (VF), or death and VT or VF alone. RESULTS Eighty-six patients had the RV lead positioned at the RV septal or right ventricular outflow tract region, combined as nonapical RV group, and 656 patients had apical RV lead location. There was no difference in the primary end point in patients with nonapical RV lead location versus those with apical RV lead location (hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.54-1.80; P = .983). Echocardiographic response to CRT-D was comparable across RV lead location groups (P > .05 for left ventricular end-diastolic volume, left ventricular end-systolic volume, and left atrial volume percent change). However, nonapical RV lead location was associated with significantly higher risk of VT/VF/death (HR 2.45; 95% CI 1.36-4.41; P = .003) and VT/VF alone (HR 2.52; 95% CI 1.36-4.65; P = .002), predominantly in the first year after device implantation. Results were consistent in patients with left bundle branch block. CONCLUSIONS In CRT-D patients, there is no benefit of nonapical RV lead location in clinical outcome or echocardiographic response. Moreover, nonapical RV lead location is associated with an increased risk of ventricular tachyarrhythmias, particularly in the first year after device implantation.

Effect on Cardiac Function of Cardiac Resynchronization Therapy in Patients With Right Bundle Branch Block (from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy [MADIT-CRT] Trial)

Cardiac resynchronization therapy (CRT) is effective for the treatment of patients with heart failure and a wide QRS duration, particularly left bundle branch block. However, subjects with right bundle branch block (RBBB) do not appear to benefit from CRT. The aim of this study was to determine whether patients with specific RBBB conduction patterns responded to CRT in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) trial. In the present post hoc analysis, patients with RBBB who received CRT with an implantable cardioverter defibrillator (n = 132) were divided into 2 groups according to the baseline QRS morphology in the inferior and high lateral leads: group 1: left anterior fascicular block (LAFB) pattern (n = 80; 60.6%); and group 2: non-LAFB pattern (n = 52; 39.4%). Subjects with RBBB who received an implantable cardioverter defibrillator served as the control group (n = 87). The primary end point was echocardiographic response to CRT, defined as percent change in left ventricular (LV) and left atrial volumes from baseline to 1 year. The secondary end point was heart failure or death. The non-LAFB group demonstrated a significantly larger percent reduction in LV end-diastolic volume, LV end-systolic volume, and left atrial volume compared to controls (-11%, p <0.0001; -17%, p <0.0001; -15%, p <0.0001, respectively) and LAFB (-5%, p = 0.028; -7%, p = 0.019; -6%; p = 0.022; respectively) by multivariate analysis. No difference was found in the 3-year crude event rates for death or heart failure among the LAFB (22%), non-LAFB (21%), or ICD-only (20%) groups (p = NS). In conclusion, conduction patterns influence echocardiographic response to CRT in patients with RBBB, with favorable reductions in the LV and left atrial volumes in those without an LAFB conduction pattern. This echocardiographic benefit did not translate into a reduction in heart failure or death during a 3-year follow-up period.

Lipid-altering therapy and atrial fibrillation.

Atrial fibrillation (AF) is a common cardiac arrhythmia with significant morbidity and public health cost. Because of limitations of efficacy and safety of conventional antiarrhythmic agents, alternative therapies for AF are needed. The potential antiarrhythmic properties of lipid-altering therapy, including the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors and fish oils, are increasingly recognized, particularly in light of their potential anti-inflammatory properties. This review examines the known effects of lipid-altering therapy on atrial arrhythmias in both experimental and clinical settings. Inflammatory states, such as postcardiac surgery and AF of recent onset, show promise as targets. In contrast, lipid-lowering therapy is less likely to affect longstanding persistent AF. Current recommendations for the use of lipid-altering therapy for prevention and treatment of AF are summarized.

Effects of lipid-altering therapies on ventricular arrhythmias and sudden cardiac death.

Sudden cardiac death remains a leading cause of mortality in the United States, with an incidence of 300,000 to 400,000 deaths annually. Despite advances in the management of cardiovascular disease, the only effective treatments proven to reduce the risk of sudden cardiac death are beta-adrenergic blockers and implantable cardioverter-defibrillators. Antiarrhythmic medications are effective at treating symptomatic and asymptomatic ventricular arrhythmias, but several are associated with increased mortality. Although effective at lowering mortality, implantable cardioverter-defibrillators pose an economic burden and some morbidity to patients when associated with frequent shock therapies. Thus, there is renewed interest in developing additional pharmacologic alternatives that could reduce the risk of fatal ventricular arrhythmias. A post hoc analysis of 2 large clinical trials suggested an association between the use of lipid-altering therapy and decreased rates of sudden death. Retrospective review of other clinical trials and experimental data using animal models provide further insight into the potential antiarrhythmic properties of lipid-altering therapy. This review examines the current status of basic science and clinical research that explores the antiarrhythmic properties of lipid-altering therapy, with a focus on 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and polyunsaturated fatty acids.

Response of right ventricular size to treatment with cardiac resynchronization therapy and the risk of ventricular tachyarrhythmias in MADIT-CRT

BACKGROUND Cardiac resynchronization therapy (CRT) is increasingly recognized for its ability to reduce ventricular tachyarrhythmias, possibly associated with left ventricular reverse remodeling, but the role of the right ventricle (RV) in this process has not been examined. OBJECTIVE The purpose of this study was to investigate the relationship between ventricular tachyarrhythmias and change in RV dimensions in patients receiving CRT with a defibrillator (CRT-D). METHODS Multivariate Cox proportional hazards regression modeling was used to assess the risk for fast (≥180 bpm) ventricular tachycardia/ventricular fibrillation (VT/VF) or death by baseline and follow-up RV size (defined as right ventricular end-diastolic area [RVEDA]) among 1495 patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). RESULTS Multivariate analysis showed that treatment with CRT-D was independently associated with a 27% (P = .003) reduction in the risk of VT/VF or death among patients with larger RVs (>first quartile RVEDA ≥13 mm(2)/m(2)) compared with implantable cardioverter-defibrillator (ICD)-only therapy, whereas in patients with smaller RVs there was no significant difference in the risk of VT/VF between the 2 treatment arms (hazard ratio = 1.00, P = .99). At 1-year follow-up, CRT-D patients displayed significantly greater reductions in RVEDA compared to ICD-only patients (P <.001), associated with a corresponding reduction in the risk of subsequent VT/VF or death (>first quartile reduction in RVEDA with CRT-D vs ICD-only: hazard ratio = 0.55, P <.001) independent of changes in left ventricular dimensions. CONCLUSION Our findings suggest that the RV may have an important role in determining the antiarrhythmic effect of CRT independent of the effect of the device on the left ventricle.

Effects of implantable cardioverter/defibrillator shock and antitachycardia pacing on anxiety and quality of life: A MADIT-RIT substudy

Background Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood. Methods We evaluated changes in QoL from baseline to 9‐month follow‐up using the EQ‐5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial—Reduce Inappropriate Therapy (MADIT‐RIT) (n = 1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1‐10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. The analysis was stratified by number of ATP or shocks (0‐1 vs ≥2) and adjusted for covariates. Results In MADIT‐RIT, 15 patients (1%) had ≥2 appropriate shocks, 38 (3%) had ≥2 appropriate ATPs. Two or more inappropriate shocks were delivered in 16 patients (1%); ≥2 inappropriate ATPs, in 70. In multivariable analysis, patients with ≥2 appropriate shocks had higher levels of shock‐related anxiety than those with ≤1 appropriate shock (P < .01). Furthermore, ≥2 inappropriate shocks produced more anxiety than ≤1 inappropriate shock (P = .005). Consistently, ≥2 appropriate ATPs resulted in more anxiety than ≤1 (P = .028), whereas the number of inappropriate ATPs showed no association with anxiety levels (P = .997). However, there was no association between QoL and appropriate or inappropriate ATP/shock (all P values > .05). Conclusions In MADIT‐RIT, ≥2 appropriate or inappropriate ICD shocks and ≥2 appropriate ATPs are associated with more anxiety at 9‐month follow‐up despite no significant changes in the assessment of global QoL by the EQ‐5D questionnaire. Innovative ICD programming reducing inappropriate therapies may help deal with patient concerns about the device.