Trends in the 30-year span of noninfectious cardiovascular implantable electronic device complications in Olmsted County.

Background: Cardiac implantable electronic devices (CIEDs), such as permanent pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, alleviate morbidity and mortality in various diseases. There is a paucity of real-world data on CIED complications and trends. Objectives: We sought to describe trends in noninfectious CIED complications over the past 3 decades in Olmsted County. Methods: The Rochester Epidemiology Project is a medical records linkage system comprising records of over 500,000 residents of Olmsted County from 1966 to present. CIED implantations between 1988 and 2018 were determined. Trends in noninfectious complications within 30 days of implantation were analyzed. Results: A total of 157 (6.2%) of 2536 patients who received CIED experienced device complications. A total of 2.7% of the implants had major complications requiring intervention. Lead dislodgement was the most common (2.8%), followed by hematoma (1.7%). Complications went up from 1988 to 2005, and then showed a downtrend until 2018, driven by a decline in hematomas in the last decade (P < .01). Those with complications were more likely to have prosthetic valves. Obesity appeared to have a protective effect in a multivariate regression model. The mean Charlson comorbidity index has trended up over the 30 years. Conclusion: Our study describes a real-world trend of CIED complications over 3 decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade due to safer practices and a better understanding of anticoagulant management.

Left bundle branch pacing vs ventricular septal pacing for cardiac resynchronization therapy.

Background: The outcomes of left bundle branch pacing (LBBP) and left ventricular septal pacing (LVSP) in patients with heart failure remain to be learned. Objective: The objective of this study was to assess the echocardiographic and clinical outcomes of LBBP, LVSP, and deep septal pacing (DSP). Methods: This retrospective study included patients who met the criteria for cardiac resynchronization therapy (CRT) and underwent attempted LBBP in 5 Mayo centers. Clinical, electrocardiographic, and echocardiographic data were collected at baseline and follow-up. Results: A total of 91 consecutive patients were included in the study. A total of 52 patients had LBBP, 25 had LVSP, and 14 had DSP. The median follow-up duration was 307 (interquartile range 208, 508) days. There was significant left ventricular ejection fraction (LVEF) improvement in the LBBP and LVSP groups (from 35.9 ± 8.5% to 46.9 ± 10.0%, P < .001 in the LBBP group; from 33.1 ± 7.5% to 41.8 ± 10.8%, P < .001 in the LVSP group) but not in the DSP group. A unipolar paced right bundle branch block morphology during the procedure in lead V1 was associated with higher odds of CRT response. There was no significant difference in heart failure hospitalization and all-cause deaths between the LBBP and LVSP groups. The rate of heart failure hospitalization and all-cause deaths were increased in the DSP group compared with the LBBP group (hazard ratio 5.10, 95% confidence interval 1.14-22.78, P = .033; and hazard ratio 7.83, 95% confidence interval 1.38-44.32, P = .020, respectively). Conclusion: In patients undergoing CRT, LVSP had comparable CRT outcomes compared with LBBP.

Trends in the 30-year span of Noninfectious Cardiovascular Implantable Electronic Device Complications in Olmsted County.

Background: Cardiovascular implantable electronic devices (CIEDs) such as permanent pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices alleviate morbidity and mortality in various diseases. There is a paucity of real-world data on CIED complications and trends. Objectives: Describe trends in noninfectious CIED complications over the past three decades in Olmsted County. Methods: The Rochester Epidemiology Project is a medical records linkage system comprising records of over 500,000 residents of Olmsted County from 1966-current. CIED implants between 1988-2018 were determined. Trends in noninfectious complications within 30 days of implant were analyzed. Results: 175 out of 2536 (6.9%) patients who received CIED experienced device complications. 3.8% of the implants had major complications requiring intervention. Lead dislodgement was the most common (2.9%), followed by hematoma (2.1%). Complications went up from 1988 to 2005, then showed a downtrend until 2018, driven by a decline in hematomas in the last decade (p<0.01). Those with complications were more likely to have prosthetic valves. Obesity appeared to have a protective effect in a multivariate regression model. The mean Charlson comorbidity score has trended up over the 30 years. Conclusions: Our study describes a real-world trend of CIED complications over three decades. Lead dislodgements and hematomas were the most common complications. Complications have declined over the last decade due to safer practices and a better understanding of anticoagulant management.

Substrate Characterization and Outcomes of Catheter Ablation of Ventricular Arrhythmias in Patients With Mitral Annular Disjunction.

BACKGROUND: Mitral annular disjunction (MAD) has recently been recognized as an arrhythmogenic entity. Data on the electrophysiological substrate as well as the outcomes of catheter ablation of ventricular arrhythmias in patients with MAD is limited. METHODS: Forty patients with MAD (mean age 47±15 years; 70% female) underwent catheter ablation for ventricular arrhythmias. Detailed clinical, electrocardiographic, cardiac imaging, and procedural data were collected. Clinical outcomes were compared between patients who had substrate modification in the MAD area and those who did not. RESULTS: Twenty-three (57.5%) patients had ablation for premature ventricular contractions, 10 (25%) patients for sustained ventricular tachycardia, and 7 (17.5%) patients for premature ventricular contraction-triggered ventricular fibrillation. Mean end-systolic MAD length was 10.58±3.49 mm on transthoracic echocardiography. Seventeen (42.5%) patients had preprocedural cardiac magnetic resonance imaging, and 5 (29%) patients had late gadolinium enhancement. Among the 18 (45%) patients who had abnormal local electrograms (low voltage, long-duration, fractionated, isolated mid-diastolic potentials) during electroanatomical mapping, 10 (25%) patients had abnormal electrograms in the anterolateral mitral annulus and/or MAD area. Substrate modification was performed in 10 (25%) patients. Catheter ablation was acutely successful in 36 (90%) patients (elimination of premature ventricular contraction or noninducibility of ventricular tachycardia). After a median follow-up duration of 54.08 (interquartile range, 10.67-89.79) months, premature ventricular contraction burden decreased from a median of 9.75% (interquartile range, 3.25-14) before the ablation to a median of 4% (interquartile range, 1-7.75) after the ablation (P=0.03 [95% CI, 0.055-6.5]). Eight (20.5%) patients had repeat ablation for ventricular arrhythmias. Substrate modification of the MAD was associated with a trend toward lower rates of repeat ablation (0% versus 26.7%; P=0.16). CONCLUSIONS: Patients with MAD have a complex arrhythmogenic substrate, and catheter ablation is effective in reducing recurrence of ventricular arrhythmias. Substrate mapping and ablation may be considered in these patients.

Trends in Cardiovascular Implantable Electronic Device Insertion Between 1988 and 2018 in Olmsted County.

OBJECTIVES: This study sought to describe trends in cardiovascular implantable electronic device (CIED) insertion over the past 3 decades in Olmsted County. BACKGROUND: Trends in CIED insertion in the United States have not been extensively studied. METHODS: The Rochester Epidemiology Project is a medical records linkage system comprising the records of all residents of Olmsted County from 1966 to the present. CIED insertion between 1988 and 2018 was determined using International Classification of Diseases-Ninth Revision, International Classification of Diseases-10th Revision, and Current Procedural Terminology codes. Age- and sex-adjusted incidence rates, adjusted to the 2010 US White population, were calculated. Trends in incidence over time, across age groups, and between sex are estimated using Poisson regression models. RESULTS: The age- and sex-adjusted incidence of device implants for the study period were as follows: overall CIED: 82.4 (95% CI: 79.2-85.6); permanent pacemaker (PPM): 62.9 (95% CI: 60.0-65.7); implantable cardioverter-defibrillator (ICD): 14.0 (95% CI: 12.6-15.3); and cardiac resynchronization therapy (CRT): 5.6 (95% CI: 4.7-6.4) per 100,000 per year. The overall incidence of CIED insertion increased between 1988 to 1993 and 2000 to 2005 and then decreased between 2000 to 2005 and 2012 to 218 (P < 0.0001). PPM and ICD insertion incidence followed these trends, whereas the incidence of CRT insertion increased between 2000 to 2005 and 2012 to 2018. CIED insertion incidence increased with age (P < 0.0001). CIED insertion incidence was greater in men (116.3 vs 57.3 per 100,000 per year in men vs women; P < 0.0001). The overall survival of CRT recipients improved (P = 0.0044). CONCLUSIONS: The incidence values for PPM and ICD implants are decreasing, while the incidence of CRT implants is increasing. CIEDs are increasingly inserted in the elderly, men, and patients with higher comorbidities.

Sinus rhythm heart rate increase after atrial fibrillation ablation is associated with lower risk of arrhythmia recurrence.

BACKGROUND: Pulmonary vein isolation (PVI) with autonomic modulation may be more successful than PVI alone for atrial fibrillation (AF) ablation and may be signaled by changes in sinus rhythm heart rate (HR) post ablation. We sought to determine if a change in sinus rhythm HR predicted AF recurrence post PVI. METHODS: Patients who underwent AF ablation from 2000 to 2011 were included if sinus rhythm was noted on ECG within 90 days pre and 7 days post ablation. Basic ECG interval and HR changes were analyzed and outcomes determined. RESULTS: A total of 1152 patients were identified (74.3% male, mean age 57 ± 11 years). Mean AF duration was 5.2 ± 5.3 years. Paroxysmal AF was noted in 712 (61.8%) of the patients. Mean EF was 61% ± 6%. Sinus rhythm HR was 61 ± 11 pre-ablation and 76 ± 13 bpm post-ablation (27% ± 24% increase, p < .001). The ability of relative HR change post-ablation to predict AF recurrence was borderline (hazard ratio 0.65 [0.41-1.01], p = .067). With patients separated into quartiles based on the relative HR change, the upper quartile with the largest relative increase in HR had a significantly lower rate of AF recurrence compared to the lowest quartile following multi variable modeling (p = .038). There were significant changes in PR (171 ± 28 to 167 ± 30 ms) and QTc (424 ± 25 to 434 ± 29 ms) intervals (both p < .001) but these were not predictive of outcome. CONCLUSION: Relative changes in HR post AF ablation correlates with AF recurrence. Further prospective studies are needed to confirm this relationship.

Sustained Improvement in Diastolic Reserve Following Percutaneous Pericardiotomy in a Porcine Model of Heart Failure With Preserved Ejection Fraction.

BACKGROUND: Heart failure with preserved ejection fraction is increasing in prevalence, but few effective treatments are available. Elevated left ventricular (LV) diastolic filling pressures represent a key therapeutic target. Pericardial restraint contributes to elevated LV end-diastolic pressure, and acute studies have shown that pericardiotomy attenuates the rise in LV end-diastolic pressure with volume loading. However, whether these acute effects are sustained chronically remains unknown. METHODS: Minimally invasive pericardiotomy was performed percutaneously using a novel device in a porcine model of heart failure with preserved ejection fraction. Hemodynamics were assessed at baseline and following volume loading with pericardium intact, acutely following pericardiotomy, and then again chronically after 4 weeks. Cardiac structure was assessed by magnetic resonance imaging. RESULTS: The increase in LV end-diastolic pressure with volume loading was mitigated by 41% (95% CI, 27%-45%, P<0.0001; ΔLV end-diastolic pressure reduced from +9±3 mm Hg to +5±3 mm Hg, P=0.0003, 95% CI, -2.2 to -5.5). The effect was sustained at 4 weeks (+5±2 mm Hg, P=0.28 versus acute). There was no statistically significant effect of pericardiotomy on ventricular remodeling compared with age-matched controls. None of the animals developed hemodynamic or pathological indicators of pericardial constriction or frank systolic dysfunction. CONCLUSIONS: The acute hemodynamic benefits of pericardiotomy are sustained for at least 4 weeks in a swine model of heart failure with preserved ejection fraction, without excessive chamber remodeling, pericarditis, or clinically significant systolic dysfunction. These data support trials evaluating minimally invasive pericardiotomy as a novel treatment for heart failure with preserved ejection fraction in humans.

Long-Term Survival of Patients With Left Ventricular Noncompaction.

Background The prognosis of left ventricular noncompaction (LVNC) remains elusive despite its recognition as a clinical entity for >30 years. We sought to identify clinical and imaging characteristics and risk factors for mortality in patients with LVNC. Methods and Results 339 adults with LVNC seen between 2000 and 2016 were identified. LVNC was defined as end-systolic noncompacted to compacted myocardial ratio >2 (Jenni criteria) and end-diastolic trough of trabeculation-to-epicardium (X):peak of trabeculation-to-epicardium (Y) ratio <0.5 (Chin criteria) by echocardiography; and end-diastolic noncompacted:compacted ratio >2.3 (Petersen criteria) by magnetic resonance imaging. Median age was 47.4 years, and 46% of patients were female. Left ventricular ejection fraction <50% was present in 57% of patients and isolated apical noncompaction in 48%. During a median follow-up of 6.3 years, 59 patients died. On multivariable Cox regression analysis, age (hazard ratio [HR] 1.04; 95% CI, 1.02-1.06), left ventricular ejection fraction <50% (HR, 2.37; 95% CI, 1.17-4.80), and noncompaction extending from the apex to the mid or basal segments (HR, 2.11; 95% CI, 1.21-3.68) were associated with all-cause mortality. Compared with the expected survival for age- and sex-matched US population, patients with LVNC had reduced overall survival (P<0.001). However, patients with LVNC with preserved left ventricular ejection fraction and patients with isolated apical noncompaction had similar survival to the general population. Conclusions Overall survival is reduced in patients with LVNC compared with the expected survival of age- and sex-matched US population. However, survival rate in those with preserved left ventricular ejection fraction and isolated apical noncompaction was comparable with that of the general population.

Burden of arrhythmia in hospitalized HIV patients.

BACKGROUND: The improved life expectancy observed in patients living with human immunodeficiency virus (HIV) infection has made age-related cardiovascular complications, including arrhythmias, a growing health concern. HYPOTHESIS: We describe the temporal trends in frequency of various arrhythmias and assess impact of arrhythmias on hospitalized HIV patients using the Nationwide Inpatient Sample (NIS). METHODS: Data on HIV-related hospitalizations from 2005 to 2014 were obtained from the NIS database using International Classification of Diseases, 9th Revision (ICD-9) codes. Data was further subclassified into hospitalizations with associated arrhythmias and those without. Baseline demographics and comorbidities were determined. Outcomes including in-hospital mortality, cost of care, and length of stay were extracted. SAS 9.4 (SAS Institute Inc., Cary, NC) was utilized for analysis. A multivariable analysis was performed to identify predictors of arrhythmias among hospitalized HIV patients. RESULTS: Among 2 370 751 HIV-related hospitalizations identified, the overall frequency of any arrhythmia was 3.01%. Atrial fibrillation (AF) was the most frequent arrhythmia (2110 per 100 000). The overall frequency of arrhythmias increased over time by 108%, primarily due to a 132% increase in AF. Arrhythmias are more frequent among older males, lowest income quartile, and nonelective admissions. Patients with arrhythmias had a higher in-hospital mortality rate (9.6%). In-hospital mortality among patients with arrhythmias decreased over time by 43.8%. The cost of care and length of stay associated with arrhythmia-related hospitalizations were mostly unchanged. CONCLUSIONS: Arrhythmias are associated with significant morbidity and mortality in hospitalized HIV patients. AF is the most frequent arrhythmia in hospitalized HIV patients.

Incremental benefit of a novel signal recording system during mapping and ablation.

AIMS: Current electrophysiology signal recording and mapping systems have limited dynamic range (DR) and bandwidth, which causes loss of valuable information during acquisition of cardiac signals. We evaluated a novel advanced signal processing platform with the objective to obtain and assess additional information of clinical importance. METHODS AND RESULTS: Over 10 canines, we compared intracardiac recordings within all cardiac chambers, in various rhythms, in pacing and during radiofrequency (RF) ablation across two platforms; a conventional system and the PURE EP™ [(PEP); Bio Sig Technologies, Inc., Los Angeles, CA, USA]. Recording cardiac signals with varying amplitudes were consistently and reproducibly observed, without loss of detail or introduction of artefact. Further the amplitude of current of injury (COI) on the unipolar signals correlated with the instantaneous contact force (CF) recorded on the sensing catheter in all the animals (r2 = 0.94 in ventricle). The maximum change in the unipolar COI correlated with the change in local electrogram amplitude during non-irrigated RF ablation (r2 = 0.61 in atrium). Reduction in artefact attributable to pacing (20 sites) and noise during ablation (48 sites) was present on the PEP system. Within the PEP system, simultaneous display of identical signals, filtered differently, aided the visualization of discrete conduction tissue signals. CONCLUSION: Compared to current system, the PEP system provided incremental information including identifying conduction tissue signals, estimates of CF and a surrogate for lesion formation. This novel signal processing platform with increased DR and minimal front-end filtering may be useful in clinical practice.

Injectable conductive hydrogel restores conduction through ablated myocardium.

INTRODUCTION: Therapies for substrate-related arrhythmias include ablation or drugs targeted at altering conductive properties or disruption of slow zones in heterogeneous myocardium. Conductive compounds such as carbon nanotubes may provide a novel personalizable therapy for arrhythmia treatment by allowing tissue homogenization. METHODS: A nanocellulose carbon nanotube-conductive hydrogel was developed to have conduction properties similar to normal myocardium. Ex vivo perfused canine hearts were studied. Electroanatomic activation mapping of the epicardial surface was performed at baseline, after radiofrequency ablation, and after uniform needle injections of the conductive hydrogel through the injured tissue. Gross histology was used to assess distribution of conductive hydrogel in the tissue. RESULTS: The conductive hydrogel viscosity was optimized to decrease with increasing shear rate to allow expression through a syringe. The direct current conductivity under aqueous conduction was 4.3 × 10-1 S/cm. In four canine hearts, when compared with the homogeneous baseline conduction, isochronal maps demonstrated sequential myocardial activation with a shift in direction of activation to surround the edges of the ablated region. After injection of the conductive hydrogel, isochrones demonstrated conduction through the ablated tissue with activation restored through the ablated tissue. Gross specimen examination demonstrated retention of the hydrogel within the tissue. CONCLUSIONS: This proof-of-concept study demonstrates that conductive hydrogel can be injected into acutely disrupted myocardium to restore conduction. Future experiments should focus on evaluating long-term retention and biocompatibility of the hydrogel through in vivo experimentation.

Trends in reported industry payments to physicians practicing cardiac electrophysiology from 2013 to 2018 in the United States.

INTRODUCTION: The need for transparency in financial relationships in the healthcare system, has culminated in Open Payments database, managed by the Center for Medicare and Medicaid Services (CMS). Since its inception in 2013, the trend in such payments to physicians practicing cardiac electrophysiology was not examined. METHODS AND RESULTS: Payment information reported to CMS from January 2013 to December 2018 was obtained from the publicly available Open Payments data set using the online query tool. The data were analyzed by an individual provider and by state. An in-depth analysis of payments in the year 2018 payments was performed. From 2014 to 2018, there was an 18% increase in the total number of payments reported from 88 877 payments in 2014 to 105 000 in 2018. Despite the increase in the total number of payments reported, the average payment steadily decreased over time, resulting in an overall reduction in the total amount of payments from 2014 to 2018 ($34.9 million to $28.2 million). Payments to the top 5% of individual recipients have also decreased over this time. In 2018, 2888 unique providers received reportable payments, a total of 105 000 payments, with a median payment amount of $1378 (interquartile range: $165-$5781). The majority of these payments were for food and beverage (82%) and travel/lodging (10%). The top five payers include Boston Scientific, Medtronic Vascular, Abbott Laboratories, Janssen Pharmaceuticals, and Biotronik. CONCLUSION: Among cardiac electrophysiologists, there is increased reporting of payments in the Open Payments program over time, with a notable decrease in the payment amount.

Feasibility of selective cardiac ventricular electroporation.

INTRODUCTION: The application of brief high voltage electrical pulses to tissue can lead to an irreversible or reversible electroporation effect in a cell-specific manner. In the management of ventricular arrhythmias, the ability to target different tissue types, specifically cardiac conduction tissue (His-Purkinje System) vs. cardiac myocardium would be advantageous. We hypothesize that pulsed electric fields (PEFs) can be applied safely to the beating heart through a catheter-based approach, and we tested whether the superficial Purkinje cells can be targeted with PEFs without injury to underlying myocardial tissue. METHODS: In an acute (n = 5) and chronic canine model (n = 6), detailed electroanatomical mapping of the left ventricle identified electrical signals from myocardial and overlying Purkinje tissue. Electroporation was effected via percutaneous catheter-based Intracardiac bipolar current delivery in the anesthetized animal. Repeat Intracardiac electrical mapping of the heart was performed at acute and chronic time points; followed by histological analysis to assess effects. RESULTS: PEF demonstrated an acute dose-dependent functional effect on Purkinje, with titration of pulse duration and/or voltage associated with successful acute Purkinje damage. Electrical conduction in the insulated bundle of His (n = 2) and anterior fascicle bundle (n = 2), was not affected. At 30 days repeat cardiac mapping demonstrated resilient, normal electrical conduction throughout the targeted area with no significant change in myocardial amplitude (pre 5.9 ± 1.8 mV, 30 days 5.4 ± 1.2 mV, p = 0.92). Histopathological analysis confirmed acute Purkinje fiber targeting, with chronic studies showing normal Purkinje fibers, with minimal subendocardial myocardial fibrosis. CONCLUSION: PEF provides a novel, safe method for non-thermal acute modulation of the Purkinje fibers without significant injury to the underlying myocardium. Future optimization of this energy delivery is required to optimize conditions so that selective electroporation can be utilized in humans the treatment of cardiac disease.

Venoarterial Extracorporeal Membrane Oxygenation Support for Ventricular Tachycardia Ablation: A Systematic Review.

Refractory ventricular tachycardia (VT) and electrical storm are frequently associated with hemodynamic compromise requiring mechanical support. This study sought to review the current literature on the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for hemodynamic support during VT ablation. This was a systematic review of all published literature from 2000 to 2019 evaluating patients with VT undergoing ablation with VA-ECMO support. Studies that reported mortality, safety, and efficacy outcomes in adult (>18 years) patients were included. The primary outcome was short-term mortality (intensive care unit stay, hospital stay, or ≤30 days). The literature search identified 4,802 citations during the study period, of which seven studies comprising 867 patients met the inclusion criteria. Periprocedural VA-ECMO was used in 129 (15%) patients and all were placed peripherally. Average inducible VTs were 2-3 per procedure and ablation time varied between 34 mins and 4.7 hours. Median ages were between 61 and 68 years with 93% males. Median duration of VA-ECMO varied between 140 minutes and 6 days. Short-term mortality was 15% (19 patients), with the most frequent causes being refractory VT, cardiac arrest, and acute heart failure. All-cause mortality at the longest follow-up was 25%. Major bleeding, vascular/access complications, limb ischemia, stroke, and acute kidney injury were reported with varying frequency of 1-6%. In conclusion, VA-ECMO is used infrequently for hemodynamic support for VT ablation. Further data on patient selection, procedural optimization, and clinical outcomes are needed to evaluate the efficacy of this strategy.

Injectable Flexible Subcutaneous Electrode Array Technology for Electrocardiogram Monitoring Device.

Implantable cardiac monitors have undergone considerable miniaturization. However, they continue to be associated with complications such as infection, bleeding/bruising, and device extrusion or migration. In this paper, we demonstrate the feasibility of using a small, flexible, injectable, subcutaneous microelectrode-based device to record electrocardiograms (ECGs). We describe the fabrication process and demonstrate the ease of insertion of the injectable ECG device in vivo swine model. We also demonstrate our device's high-density channel microelectrode array's ability to detect the P, R, and T waves. The amplitude of these waves showed excellent correlation with distance of the bipolar electrodes used to detect them. Given the success of our initial studies, this device has the potential to improve the safety profile of implantable cardiac monitors and simplify the implantation procedure to allow for placement in a primary care setting.

A novel percutaneous stabilizing sheath for minimal invasive epicardial echocardiography and ablation.

PURPOSE: Epicardial ablation and mapping are critical adjuncts to the electrophysiologist's approach to arrhythmias; however, ablation within the epicardial space requires the avoidance of coronary arteries (CA). We aimed to evaluate the feasibility and performance of a novel-stabilizing ablation sheath housing an intracardiac echocardiography (ICE) catheter to (1) obtain Epicardial Echocardiography (EE) images, (2) visualize CAs, and (3) enable targeted delivery of radiofrequency energy away from visualized CAs. METHODS: We designed a sheath that could enclose a regular ICE catheter. This sheath has flanges and a balloon, with three interspersed windows surrounded by an electrode. In an acute canine model (N = 6), the sheath was manipulated within the pericardial space to visualize cardiac structures and CAs. Visualization of CAs was confirmed with angiography. Ablation was then performed through the window either proximal or distal to the CA. RESULTS: The novel sheath was successfully deployed in six canines, with no acute procedural complications. Images with an excellent spatial resolution of cardiac structures were obtained including the right ventricular outflow tract; aortic, pulmonary, and mitral valves; and left atrial appendage. CAs were successfully visualized, and ablation from a sheath window either proximal or distal to the CA did not produce angiographic or histopathological evidence of CA damage despite evidence of acute injury to the adjacent ablated myocardium. CONCLUSIONS: This novel percutaneous stabilizing sheath was able to successfully obtain high-quality EE images as well as provide a non-fluoroscopic intra-procedural means to visualize CAs. Use of this sheath enabled successful delivery of energy to avoided CA damage.

Development of a novel ablation hood to prevent systemic embolization of microbubbles and particulate emboli.

BACKGROUND: Atrial fibrillation ablation results in microbubbles and particulate emboli formation. We aimed to develop and test the early feasibility of a novel ablation hood to contain microbubbles and particulate emboli with the ultimate goal of preventing systemic embolization. METHODS: In seven canines, we developed, iterated, and tested a novel retractable hood that can cover the catheter-tissue ablation site. The number and volume (nL) of microbubbles formed during ablation with and without the hood was measured using an extracorporeal circulation loop. Wilcoxon's signed-rank test was used to compare the number of bubbles detected with and without the hood. RESULTS: The hood reduced systemic embolization of microbubbles in 21/28 (75%) of ablations. Both atrial and ventricular ablations showed a statistically significant reduction in bubble number (476 ± 811 without hood vs 173 ± 226 with hood, p = 0.02; 2669 ± 1623 without hood vs 1417 ± 970 with hood, p = 0.04, respectively) and bubble volume (3.3 ± 7.6 nL without hood vs 0.2 ± 0.56 nL with hood, p = 0.006; 6.1 ± 5.2 nL without hood vs 1.9 ± 1.4 nL with hood, p = 0.05, respectively). CONCLUSIONS: Use of a novel hood to cover the ablation catheter at the site of catheter-tissue contact has the potential to provide a means to reduce systematic embolization of microbubbles. Further work is required to examine particulate emboli, but these data show the early feasibility of this design concept.