Mulpuru, Siva K.

AbstractObjectiveThis study sought to determine if single‐chamber operation and/or loss of rate response (RR) during elective replacement indicator (ERI) in patients with dual‐chamber pacemakers lead to increased symptom burden, healthcare utilization, and atrial fibrillation (AF).BackgroundDual‐chamber pacemakers often change from dual‐ to single‐chamber pacing mode and/or lose RR functionality at ERI to preserve battery. Single‐chamber pacing increases the incidence of heart failure, AF, and pacemaker syndrome suggesting these changes may be deleterious.MethodsA retrospective analysis of 700 patients was completed. Three comparisons were analyzed: Comparison 1: mode change and RR loss versus no change; Comparison 2: RR loss only versus no change; Comparison 3: mode change only versus no change (in patients with no RR programmed at baseline).ResultsIn Comparison 1, 121 (46%) patients with setting changes experienced symptoms (most often dyspnea and fatigue/exercise intolerance) versus 3 (4%) without setting changes (p < .0001). Similar results were noted in Comparisons 2 and 3 (p = .0016 and p = .0001, respectively). In Comparison 1, patients with setting change sought provider contact more than patients without setting changes (p = .0001). A significant difference was not noted in Comparison 2 or 3. Overall 14 (2%) patients were hospitalized, all of whom had setting changes.ConclusionsSetting changes at ERI including a change from dual‐ to single‐chamber pacing and/or loss of RR results in a significantly increased symptom burden and increased healthcare utilization.

AbstractIntroductionVenous stenosis is a well‐recognized complication of transvenous leads (TVLs) that is encountered during lead revisions or device upgrades. We here report the outcomes of TVL placement facilitated by fibroplasty or tunneling (TUN) procedure.MethodsWe conducted a single‐center retrospective cohort study of all patients undergoing TVL implantation requiring fibroplasty or TUN from 2005 to 2017. Medical records and procedure reports were reviewed for relevant data. Outcomes for fibroplasty and TUN to facilitate TVL placement were compared.ResultsSixty patients had fibroplasty and thirty‐five patients had a TUN procedure. There was no difference in procedure success rates between the two groups (97% fibroplasty vs. 100% TUN; p = .98). The fluoroscopy time was longer (fibroplasty = 39.7 ± 21.5 min vs. TUN = 29.2 ± 21.3 min; p = .01) and the total procedural time was shorter in the fibroplasty group (fibroplasty = 247 ± 77.8 min vs. TUN = 287 ± 77.1 min; p = .01). TUN was associated with a significantly higher incidence of acute complications (fibroplasty = 0 vs. TUN = 8; p = .002) most requiring invasive intervention and/or transfusion with blood products. Long‐term complications requiring additional device‐related procedures were comparable between the two groups (fibroplasty = 6 vs. TUN = 6; logrank p = .21).ConclusionsFor patients with venous stenosis requiring additional TVL, balloon fibroplasty is associated with similar rates of success and a significantly decreased incidence of acute complications when compared with subcutaneous TUN.

Abstract Background Coronary artery disease (CAD) and atrial fibrillation (AF) are commonly associated. Co-treatment with multiple anti-thrombotic agents can increase the risk of bleeding. Purpose We sought to evaluate patient-centered outcomes in patients with AF on double therapy with direct oral anticoagulants (DOACs) compared to patients with standard triple therapy, [a vitamin K antagonist (VKA) plus dual antiplatelet therapy]. Methods We performed an extensive systematic review of the literature and meta-analysis of randomized controlled trials reporting outcomes of patients receiving double therapy with DOACs compared to triple therapy with VKAs in patients with AF undergoing percutaneous coronary intervention (PCI). Patient-centered outcomes were the International Society of Thrombosis and Hemostasis (ISTH) major or clinically relevant non-major bleeding (CRNB), all-cause mortality, major adverse cardiovascular events (MACE), myocardial infarction, stent thrombosis, and stroke. Results Four randomized controlled trials (9602 patients) met our inclusion criteria. Compared to VKAs, DOACs were associated with significantly lower ISTH major bleeding/ CRNB (RR - 0.75, 95% CI: 0.67-0.82, p &lt; 0.00001, I2 = 11%). There were no statistically significant differences in the efficacy outcomes, including myocardial infarction (RR- 0.99, 95% CI :0.79-1.25, p = 0.96, I2 = 0%), stent thrombosis (RR - 0.97, 95% CI: 0.6-1.55, p = 0.89, I2 = 0%), ischemic stroke (RR - 0.76, 95% CI: 0.5-1.15, p = 0.19, I2 = 0%), all-cause mortality (RR - 1.06, 95% CI: 0.85-1.31, p = 0.61, I2 = 0%) and MACE (RR - 1.06, 95% CI: 0.91-1.22, p = 0.97, I2 = 0%). Conclusion Compared with triple therapy with VKAS, double therapy with DOACs is associated with a reduced risk of bleeding and is as effective in patients with AF undergoing PCI. Abstract Figure.

AbstractBackgroundAtrial fibrillation (AF) and coronary artery disease (CAD) are commonly associated. Cotreatment with multiple antithrombotic agents can increase the risk of bleeding. We sought to evaluate patient‐centered outcomes in patients with AF on double therapy with direct oral anticoagulants (DOACs) compared to patients with standard triple therapy, [a vitamin K antagonist (VKA) plus dual antiplatelet therapy].MethodsWe performed a literature search of randomized controlled trials (RCTs) reporting outcomes of patients receiving double therapy with DOACs compared to triple therapy with VKAs in patients with AF undergoing percutaneous coronary intervention (PCI). Patient‐centered outcomes were the International Society of Thrombosis and Hemostasis (ISTH) major or clinically relevant nonmajor bleeding (CRNB), all‐cause mortality, major adverse cardiovascular events (MACE), stent thrombosis, myocardial infarction, and stroke.ResultsFour RCTs (9602 patients) met our inclusion criteria. Compared to VKAs, DOACs were associated with significantly lower ISTH major bleeding/ CRNB (RR: 0.75, 95% CI: 0.67‐0.82, P < .00001, I2 = 11%). There were no statistically significant differences in the efficacy outcomes, including myocardial infarction (RR: 0.99, 95% CI :0.79‐1.25, P = .96), stent thrombosis (RR: 0.97, 95% CI: 0.6‐1.55, P = .89), ischemic stroke (RR: 0.76, 95% CI: 0.5‐1.15, P = .19), all‐cause mortality (RR: 1.06, 95% CI: 0.85‐1.31, P = .61), and MACE (RR: 1.06, 95% CI: 0.91‐1.22, P = .97).ConclusionCompared with triple therapy with VKAS, double therapy with DOACs is associated with a reduced risk of bleeding and is as effective in patients with AF undergoing PCI.

Abstract Background Venous stenosis is a well-recognized complication of transvenous leads when patients require lead revisions or device upgrade. In these cases, balloon venoplasty or alternative venous access with subcutaneous tunneling can be performed. Purpose Compare the outcomes of venoplasty vs. tunneling in patients requiring additional transvenous lead implantation. Methods A single center retrospective cohort study of all patients undergoing lead implantation/revision requiring venoplasty or tunneling from 2005–2017. Chi-squared and Wilcoxon Rank-Sum tests were used to compare categorical and continuous variables. Results Ninety five patients met our inclusion criteria (60 venoplasty & 35 tunneling). There was no difference in procedure success rates (p-value=0.98). Tunneling was associated with less fluoroscopy time but higher incidence of acute complications (0% vs. 23%, p-value=0.002) most requiring invasive intervention and/or blood product transfusion. Long term outcomes were comparable and related to lead failure or infection. Outcomes for tunneling vs. venoplasty Variable Tunneling (n=35) Venoplasty (n=60) p-value Age Y 67 (23–84) 70 (29–91) 0.25 Male (%) 24 (69%) 41 (68%) 0.98 Number of existing leads 2.1 (1–4) 2.4 (0–4) 0.1 Age of oldest lead 7.0 (0–21) 7.2 (0–33) 0.73 Number of new leads 1.2 (1–3) 1.4 (1–3) 0.26 Fluoroscopy time (SD) min 29.2 (21.3) 39.7 (21.5) 0.012 Procedure success (%) 35 (100%) 55 (92%) 0.9 Acute complications (%) 8 (23%)1 0 (0%) 0.0002 Pocket hematoma/bleed 4 (11%)2 Hemothorax 2 (6%)3 Pericarditis 1 (3%) Lead compromise 1 (3%) Follow up M 18 (0–76) 28 (0–98) N/A Long term lead issues (%) 6 (17%) 10 (17%) 0.95 Long term complication requiring intervention 4 (11%) 8 (13%) N/A Procedure success: functional lead placed as a result of venoplasty or tunneling. 1Two patients required blood products. 2Two patients required invasive intervention. 3One patient required chest tube and the other ICU admission. Conclusions Balloon venoplasty is associated with similar rates of success and a less incidence of acute complications when compared subcutaneous tunneling. Acknowledgement/Funding NIH T32 Training Grant HL07111-40

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.

AbstractIntroductionMyocardial infarction (MI) is associated with an increase in subsequent heart failure (HF), recurrent ischemic events, sudden cardiac arrest, and ventricular arrhythmias (SCA‐VA). The primary objective of the study to determine the role of intercurrent HF and ischemic events on the development of SCA‐VA following first type I MI.Methods and resultsA retrospective cohort study of patients experiencing first type 1 MI in Olmsted County, Minnesota (2002‐2012) was conducted by identifying patients using the medical records linkage system (Rochester epidemiology project). Patients aged ≥18 years were followed from the time of MI till death or 31 July, 2017. Intercurrent HF and ischemic events were the primary exposures following MI and their association with outcome SCA‐VA was assessed. Eight hundred and sixty‐seven patients (mean age was 63 ± 14.5 years; 69% male; 49.8% ST‐elevation myocardial infarction) who had their first type I MI during the study period were included. Majority of acute MI patients were revascularized using percutaneous coronary intervention and bypass surgery (628 [72.43%] and 87 [10.03%] respectively). During a mean follow‐up of 7.69 ± 4.17 years, HF, recurrent ischemic events and SCA‐VA occurred in 155 (17.9%), 245 (28.3%), and 40 (4.61%) patients respectively. Low ejection fraction (adjusted hazard ratio [HR] 0.95; 95% confidence interval [CI], 0.93‐0.98; P < .001), intercurrent HF (adjusted HR 3.11; 95% CI, 1.39‐6.95; P = .006) and recurrent ischemic events (adjusted HR 3.47; 95% CI, 1.68‐7.18; P < .001) were associated with subsequent SCA‐VA.ConclusionSCA‐VA occurred in a small proportion of patients after MI and is associated with intercurrent HF and recurrent ischemic events.

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.