P4126Safety of magnetic resonance imaging in patients with non-conditional cardiac implantable electronic devices: A systematic review and meta-analysis
Abstract Recent guideline statements approve the performance of magnetic resonance imaging (MRI) in patients with non-conditional cardiac implantable electronic devices (CIEDs) under certain closely monitored conditions. Data from current registries may have lower power to discern changes that may occur in the CIED after the MRI. Objective We aimed to systematically review the literature to identify the adverse events and significance of changes in device function associated with performing MRI in patients with CIEDs Methods A comprehensive literature search of the databases was performed between 1980- 2017. Two independent reviewers selected studies and extracted data. A random-effects model was used for meta-analysis. Results A total of 7,422 patients underwent 8,865 MRI studies. No death occurred post MRI. Clinical adverse events were extremely rare (mostly less than 1%) and are summarized in Table 1. No significant changes in the pooled mean effect size estimate was noted for the changes in the lead parameters (pacing threshold, sensing and impedance) Binary outcomes post magnetic resonance imaging in patients with non-conditional cardiac implantable electronic devices Outcome Sample size Number of patients Rate SE LL of CI UL of CI Death 7401 0 0 0 0 0 Atrial arrhythmia 7173 10 0.001 0.0004 0.0007 0.0024 Ventricular arrhythmia 7371 9 0.0012 0.0004 0.0006 0.0022 Oversensing 4981 17 0.0034 0.0008 0.0020 0.0053 Inhibition of pacing 7371 6 0.0008 0.0003 0.0003 0.0016 Lead Failure/Generator Failure 7475/7475 2/8 0.0002/0.0011 0.0001/0.0004 0.0001/0.0005 0.0009/0.002 Power on Reset 1388 105 0.0131 0.0014 0.0107 0.0161 Did not complete scan 6851 13 0.0019 0.0005 0.0011 0.0031 Chest pain 7080 11 0.0021 0.0004 0.0008 0.0027. Lead threshold rise (>0.5v/>50%-A/V) 5076/6246 12/16 0.0024/0.0026 0.0007/0.0006 0.0013/0.0015 0.0040/0.0041 Change in Battery voltage >0.04V 7132 42 0.0061 0.0009 0.0043 0.0079 Sensing decrease >50%-A/V 5087/5834 17/9 0.0033/0.0015 0.0008/0.0005 0.0020/0.0008 0.0052/0.0028 Impedance changes >50ohms/>50% 5810 22 0.0038 0.0008 0.0024 0.0057 Rise in cardiac enzymes 1703 26 0.0152 0.0030 0.0102 0.0219 A, atrial; V, ventricular; SE, standard Error; LL, lower limit; UL, upper limit; CI, Confidence intervals. Conclusions MRI in patients with non-conditional CIEDs can be performed with high degree of safety and low rate of clinical events when performed under standardized protocols Acknowledgement/Funding None
Analysis of Temporal Trends and Variation in the Use of Defibrillation Testing in Contemporary Practice
AbstractBackgroundInappropriate sinus tachycardia (IST) remains a clinical challenge because patients often are highly symptomatic and not responsive to medical therapy.ObjectiveTo study the safety and efficacy of stellate ganglion (SG) block and cardiac sympathetic denervation (CSD) in patients with IST.MethodsTwelve consecutive patients who had drug‐refractory IST (10 women) were studied. According to a prospectively initiated protocol, five patients underwent an electrophysiologic study before and after SG block (electrophysiology study group). The subsequent seven patients had ambulatory Holter monitoring before and after SG block (ambulatory group). All patients underwent SG block on the right side first, and then on the left side. Selected patients who had heart rate reduction ≥15 beats per minute (bpm) were recommended to consider CSD.ResultsThe mean (SD) baseline heart rate (HR) was 106 (21) bpm. The HR significantly decreased to 93 (20) bpm (P = .02) at 10 minutes after right SG block and remained significantly slower at 97(19) bpm at 60 minutes. Left SG block reduced HR from 99 (21) to 87(16) bpm (P = .02) at 60 minutes. SG block had no significant effect on blood pressure or HR response to isoproterenol or exercise (all P > .05). Five patients underwent right (n = 4) or bilateral (n = 1) CSD. The clinical outcomes were heterogeneous: one patient had complete and two had partial symptomatic relief, and two did not have improvement.ConclusionSG blockade modestly reduces resting HR but has no significant effect on HR during exercise. Permanent CSD may have a modest role in alleviating symptoms in selected patients with IST.
Contemporary Management of Antiplatelet and Anticoagulation for Cardiac Implantable Device Procedures
Abstract Abstract 5247 Background: Vena cava filters (VCF) has been used as a method to prevent pulmonary embolism (PE). The indication for VCF in patients with venous thromboembolism (VTE) according to the American College of Chest Physicians (ACCP) guidelines has been changed to recommend that VCF is only indicated in case of contraindication to anticoagulation. Also, there is very limited data describing the long-term effectiveness and safety of these devices if they are not removed. There is no data for VCF in Korea. The aim of this study is to evaluate and compare the change of practice patterns of VCF according to the change of the ACCP guidelines and the outcomes of VCF. Patients and Method: The data from patients who had the placement of VCF from Jan 2001 to Mar 2010 was collected from 6 academic institutes in Korea, retrospectively. We analyzed the patients grouped into 3 groups according to ACCP guidelines published year. These are -2004 group, 2005–2008 group, and 2009- group. Results: All 460 cases were collected and analyzed. Permanent and retrievable filter was 109 (24%) and 351 (76%), respectively. 49% of retrievable filters was attempted to remove and 88% removal success rate was showed. The patient's number is 79 in -2004 group (17%), 254 in 2005–2008 group (55%), and 127 in 2009- group (28%), respectively. The number of patients in indications of VCF was contraindication to anticoagulation 177 (38%), extensive thrombosis for preventing PE 207 (45%), recurrent VTE during anticoagulation 39 (8%), and others 37 (9%), respectively. The practice pattern in indication for VCF was changed in recurrent VTE during anticoagulation (P=0.012). Any complications after VCF insertion were developed in 107/460 (23%) dung follow-up. Inferior vena cava thrombosis, new DVT after placement of VCF, and new DVT with PE after placement of VCF were developed in 45/460 (10%), 91/460 (20%), and 14/460 (3%), respectively. Median follow-up durations were 49.6 months (range, 0–124.4), 12.3 months (0–67.5) and 6.0 months (0–26.9) for -2004, 2005–2008, and 2009- group, respectively. Vena cava thrombosis was significantly decreased in 2009- group (P=0.022). 75% thrombosis-free time was 3.7 months, 13.0 months, and not estimable in -2004, 2005–2008, and 2009- group, respectively (P=0.10). Conclusion: This is first report on VCF in Korea. The practice for indication of VCF insertion in patients with VTE was still out of boundaries from the ACCP guidelines in Korea. Complications after VCF insertion was decreased as time went by. The more follow-up durations was needed to evaluate the development of complication or thrombosis after VCF insertion in 2005–2008 group and 2009- group. Prospective randomized study is needed in Korea to confirm that VCF insertion plus anticoagulation will truly decrease the development of PE than standard anticoagulation. Disclosures: No relevant conflicts of interest to declare.
Relationship of Stem Cell Transplant and Risk of Atrial Fibrillation in Multiple Myeloma: A Case-Control Study.
Abstract Background: Clinical observations within our tertiary care setting suggested that atrial arrhythmia is common following hematopoietic stem-cell transplant (SCT). Yet little is known with regard to the incidence of such arrhythmia and factors contributing to its development. We assessed the frequency of first atrial fibrillation/flutter (AF/flutter) development in multiple myeloma (MM) patients who underwent SCT at the Mayo Clinic over a 4 year period. Method: Using a case-control design, we compared 395 consecutive patients who underwent SCT at the Mayo Clinic during the period 2002–2005 to control subjects who did not have SCT (2:1 matched by age, gender, and date of MM diagnosis) in terms of the baseline risk factors and the frequency of new AF/flutter after MM diagnosis. Patients who had a prior history or evidence of atrial arrhythmia were excluded from analyses. Factors predictive of atrial arrhythmia in the cases were also determined. Results: First AF/Flutter developed in 38 of 395 cases (mean age 58 ± 9 years) and 47 of 790 controls subjects within 5 years of MM diagnosis (P=0.002). The 5-year Kaplan-Meier estimates of the risk of AF/flutter were 17% and 8% for cases and controls, respectively. Amongst the cases who developed new AF/flutter, the onset of the arrhythmia was within 21 days of SCT for the majority (94%). In multivariable analysis, body weight change of ≥3% in the first week post-transplant (HR 2.86; CI 1.13–7.24; P=0.026) and presence of diastolic dysfunction (HR 1.79; CI 0.99–3.23; p=0.054) at MM diagnosis were independent predictors of first AF/flutter in the cases, adjusting for age, sex, and well established clinical risk factors. Conclusion: The risk for new AF/flutter was remarkably high in the early post- SCT period in MM patients. In addition to established risk factors for atrial arrhythmia, a weight change ≥3% during the first 7 days after SCT, and the presence of diastolic dysfunction at baseline, were independent novel risk factors for new AF/flutter. These findings warrant further investigation, as modification of fluid management and diastolic filling may potentially lower the risk of post-SCT atrial arrhythmia.
Double-Blind, Placebo-Controlled, Randomized Clinical Trial of the Effect of the Dietary Supplement S-Adenosyl-L-Methionine (AdoMet) on Plasma Homocysteine (Hcy) Levels in Healthy Human Subjects.
Abstract BACKGROUND: S-adenosyl-L-methionine (AdoMet or SAM-e®) is a commonly used nutritional supplement available in the United States since 1999. AdoMet is metabolized to homocysteine (Hcy), a potential cardiovascular risk factor. A few open-label, single-arm studies have reported on the effect of exogenous AdoMet on the levels of Hcy in humans; however, this has not been tested in a double-blind, randomized clinical trial. As a nutritional supplement, AdoMet is subject only to limited regulation by the FDA, despite being used to treat clinical diseases such as depression and osteoarthritis. AdoMet is the methyl donor for small molecule, DNA, RNA, and protein methylation reactions; therefore, further understanding the biology of the AdoMet/Hcy system is important. We hypothesized that exogenous AdoMet would increase plasma Hcy levels. METHODS: In a double-blind, placebo-controlled, randomized clinical trial, 93 healthy human subjects were screened and 52 were treated with placebo (26) or 800 mg per day AdoMet (26) pills for 4 weeks. Pre- and post-treatment Hcy levels were measured. The primary endpoint was change in Hcy level. Secondary endpoints included an interim Hcy level, high sensitivity C-reactive protein (hsCRP) levels, lipid profile, and transaminases. Exclusion criteria included pregnancy and concurrent use of medications associated with changes in Hcy. RESULTS: Of 52 subjects enrolled, 45 were evaluable at the end of treatment. Subject characteristics and dropout rates were similar between placebo and control groups. Adverse events were minor and were not different between placebo and AdoMet. The primary endpoint, change in Hcy, was not significantly different between the groups (mean (umol/L), baseline: 7.43 (placebo), 8.25 (AdoMet), P=0.358; 4 week: 7.66 (placebo), 8.06 (AdoMet), P = 0.683; Baseline − 4 week: 0.23 (placebo), −0.19 (AdoMet), P = 0.427). No statistically significant difference in change in Hcy or hsCRP at 2 or 4 weeks was noted. This was true for both absolute differences as well as relative percent changes. A small decrease in ALT was observed at 2 weeks in the AdoMet group compared to the placebo group (P = 0.027). AdoMet is used in the treatment of liver diseases. There was a small, but statistically significant (P = 0.028) decrease in total cholesterol in the AdoMet group as compared to the placebo group. Interestingly, a subject with the highest baseline Hcy level had a decline in Hcy on AdoMet. Study limitations include no evaluation of AdoMet serum levels or measurement of the effect of AdoMet on DNA methylation patterns. CONCLUSIONS: AdoMet seems well tolerated and in a dose of 800 mg/day for 4 weeks does not appear to significantly affect Hcy levels in the blood. Future clinical trials of AdoMet should monitor Hcy levels with extended use of AdoMet to confirm its safety with long term use. Clinicaltrials.gov ID: NCT00284011.
Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm
Background: Percutaneous stellate ganglion blockade (SGB) has been used for drug-refractory electrical storm due to ventricular arrhythmia (VA); however, the effects and long-term outcomes have not been well studied. Methods: This study included 30 consecutive patients who had drug-refractory electrical storm and underwent percutaneous SGB between October 1, 2013, and March 31, 2018. Bupivacaine, alone or combined with lidocaine, was injected into the neck with good local anesthetic spread in the vicinity of the left stellate ganglion (n=15) or both stellate ganglia (n=15). Data were collected for patient clinical characteristics, immediate and long-term outcomes, and procedure-related complications. Results: Clinical characteristics included age, 58±14 years; men, 73.3%; and left ventricular ejection fraction, 34±16%. At 24 hours, 60% of patients were free of VA. Patients whose VA was controlled had a lower hospital mortality rate than patients whose VA continued (5.6% versus 50.0%; P =0.009). Implantable cardioverter-defibrillator interrogation showed a significant 92% reduction in VA episodes from 26±41 to 2±4 in the 72 hours after SGB ( P <0.001). Patients who died during the same hospitalization (n=7) were more likely to have ischemic cardiomyopathy (100% versus 43.5%; P =0.03) and recurrent VA within 24 hours (85.7% versus 26.1%; P =0.009). There were no procedure-related major complications. Conclusions: SGB effectively attenuated electrical storm in more than half of patients without procedure-related complications. Percutaneous SGB may be considered for stabilizing ventricular rhythm in patients for whom other therapies have failed.
Incidence and Natural History of Left Bundle Branch Block Induced Cardiomyopathy
AbstractBackgroundRecipients of implantable cardioverter defibrillator (ICD) generator replacement with multiple medical comorbidities may be at higher risk of adverse outcomes that attenuate the benefit of ICD replacement. The aim of this investigation was to study the association between the Charlson comorbidity index (CCI) and outcomes after ICD generator replacement.MethodsAll patients undergoing first ICD generator replacement at Mayo Clinic, Rochester and Beth Israel Deaconess Medical Center, Boston between 2001 and 2011 were identified. Outcomes included: (a) all‐cause mortality, (b) appropriate ICD therapy, and (c) death prior to appropriate therapy. Multivariable Cox regression analysis was performed to assess association between CCI and outcomes.ResultsWe identified 1421 patients with mean age of 69.6 ± 12.1 years, 81% male and median (range) CCI of 3 (0‐18). During a mean follow‐up of 3.9 ± 3 years, 52% of patients died, 30.6% experienced an appropriate therapy, and 23.6% died without experiencing an appropriate therapy. In multivariable analysis, higher CCI score was associated with increased all‐cause mortality (Hazard ratio, HR 1.10 [1.06‐1.13] per 1 point increase in CCI, P < .001), death without prior appropriate therapy (HR 1.11 [1.07‐1.15], P < .0001), but not associated with appropriate therapy (HR 1.01 [0.97‐1.05], P = .53). Patients with CCI ≥5 had an annual risk of death of 12.2% compared to 8.7% annual rate of appropriate therapy.ConclusionsCCI is predictive of mortality following ICD generator replacement. The benefit of ICD replacement in patients with CCI score ≥5 should be investigated in prospective studies.