Safety of multi-access site venous closure following catheter ablation of atrial fibrillation and flutter.

BACKGROUND: Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications. METHODS: Thirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications. RESULTS: Mean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site. CONCLUSIONS: This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site.

Long-term performance of single-connector (DF4) implantable defibrillator leads.

AIMS: Single-connector (DF4) defibrillator leads have become the predominantly implanted transvenous implantable cardioverter-defibrillator lead. However, data on their long-term performance are derived predominantly from manufacturer product performance reports. METHODS AND RESULTS: We reviewed medical records in 5289 patients with DF4 leads between 2011 and 2023 to determine the frequency of lead-related abnormalities. We defined malfunction as any single or combination of electrical abnormalities requiring revision including a sudden increase (≥2×) in stimulation threshold, a discrete jump in high-voltage impedance, or sensing of non-physiologic intervals or noise. We documented time to failure, predictors of failure, and management strategies. Mean follow-up after implant was 4.15 ± 3.6 years (median = 3.63), with 37% of leads followed for >5 years. A total of 80 (1.5%) leads demonstrated electrical abnormalities requiring revision with an average time to failure of 4 ± 2.8 years (median = 3.5). Of the leads that malfunctioned, 62/80 (78%) were extracted and replaced with a new lead and in the other 18 cases, malfunctioned DF4 leads were abandoned, and a new lead implanted. In multivariable models, younger age at implant (OR 1.03 per year; P < 0.001) and the presence of Abbott/St. Jude leads increased the risk of malfunction. CONCLUSION: DF4 defibrillator leads demonstrate excellent longevity with >98.3% of leads followed for at least 5 years still functioning normally. Younger age at implant and lead manufacturer are associated with an increased risk of DF4 lead malfunction. The differences in lead survival between manufacturers require further investigation.

Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

INTRODUCTION: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. METHODS: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. RESULTS: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). CONCLUSIONS: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

Novel use of an irrigated ablation catheter to monitor real-time hemodynamics during ablation.

INTRODUCTION: Hemodynamic decompensation during catheter ablation occurs due to prolonged procedure time and irrigant delivery directly into the cardiac chambers. Real-time hemodynamic monitoring of patients undergoing catheter ablation procedures may identify patients at risk of decompensation; we set out to assess the feasibility of a novel, real-time, intracardiac pressure monitoring system using a standard irrigated ablation catheter. METHODS: We studied 13 consecutive who underwent pressure measurement of the left atrium (LA) and left ventricle (LV) via transeptal access with a Swan Ganz (SG) catheter followed by two commercially available irrigated ablation catheters. Pressure waveform data was extracted to compare LA peak pressure, LV peak systolic pressure, LV end-diastolic pressure, and waveform analysis. RESULTS: Comparison between the SG and ablation catheters (AblA; AblB) demonstrated that LV systolic pressure (0.61-16.8 mmHg; 1.32-18.2 mmHg), and LV end-diastolic pressure (-3.4 to 2.8 mmHg; -3.0 to 3.35 mmHg) were well correlated and had accepted repeatability. Ablation waveforms demonstrated an 89.9 ± 6.4% correlation compared to SG waveforms. CONCLUSION: Pressure measurements derived from an irrigated ablation catheter are accurate and reliable when compared to an SG catheter. Further studies are needed to determine how real-time pressure monitoring can improve outcomes during ablation procedures.

The Feasibility and Safety of Flecainide Use Among Patients With Varying Degrees of Coronary Disease.

BACKGROUND: Class IC antiarrhythmic agents are effective for treating atrial tachyarrhythmias, but their use is restricted in patients with coronary artery disease (CAD). Data on the safety of the use of IC agents in patients with CAD in the absence of recent acute coronary syndromes are lacking. OBJECTIVES: This study sought to evaluate the safety and feasibility of treatment with IC agents in patients with varying degrees of CAD in a large serial, real-world cohort. METHODS: We retrospectively identified all patients at our institution from January 2005 to February 2021 on a IC agent (n = 3,445) and those on sotalol or dofetilide (n = 2,216) as controls, excluding those with a prior history of ventricular tachycardia, implantable cardioverter-defibrillator placement, or nonrevascularized myocardial infarction. Baseline clinical characteristics included degree of CAD (categorized as none, nonobstructive, or obstructive), other comorbid illness, and medication use. Clinical outcomes, including survival, were ascertained. We performed Cox regression analysis to evaluate the effect of IC use on event-free survival across varying degrees of CAD. RESULTS: After adjustment for baseline characteristics, there was an independent association between IC use and improved mortality. However, there was an interaction between IC use and degree of CAD (compared to sotalol) demonstrating poorer event-free survival among those with obstructive coronary disease (HR: 3.80; 95% CI: 1.67-8.67; P = 0.002). CONCLUSIONS: Among select patients with nonobstructive CAD and without a history of ventricular tachycardia, IC agents are not associated with increased mortality. Therefore, these agents may be an option for some patients in whom they are frequently restricted. Further prospective studies are warranted.

Long Term Follow-Up of Stereotactic Body Radiation Therapy for Refractory Ventricular Tachycardia in Advanced Heart Failure Patients.

Background: Initial studies of stereotactic body radiation therapy (SBRT) for refractory ventricular tachycardia (VT) have demonstrated impressive efficacy. Follow-up analyses have found mixed results and the role of SBRT for refractory VT remains unclear. We performed palliative, cardiac radio ablation in patients with ventricular tachycardia refractory to ablation and medical management. Methods: Arrhythmogenic regions were targeted by combining computed tomography imaging with electrophysiologic mapping with collaboration from a radiation oncologist, electrophysiologist and cardiac imaging specialist. Patients were treated with a single fraction 25 Gy. Total durations of VT, the quantity of antitachycardia pacing (ATP) and shocks before and after treatment as recorded by implantable cardioverter-defibrillators (ICDs) were analyzed. Follow-up extended until most recent device interrogation unless transplant, death or repeat ablation occurred sooner. Results: Fourteen patients (age 50-78, four females) were treated and had an average of two prior ablations. Nine had ACC/AHA Stage D heart failure and three had left ventricular assist devices (LVAD). Two patients died shortly after SBRT, one received a prompt heart transplant and another had significant VT durations in the following months that were inaccurately recorded by their device. Ten of the 14 patients remained with adequate data post SBRT for analysis with an average follow-up duration of 216 days. Seven of those 10 patients had a decrease in VT post SBRT. Comparing the 90 days before treatment to cumulative follow-up, patients had a 59% reduction in VT, 39% reduction in ATP and a 60% reduction in shocks. Four patients received repeat ablation following SBRT. Pneumonitis was the only complication, occurring in four of the fourteen patients. Conclusion: SBRT may have value in advanced heart failure patients with refractory VT acutely but the utility over long-term follow-up appears modest. Prospective randomized data is needed to better clarify the role of SBRT in managing refractory VT.

Same-Day Versus Next-Day Discharge Strategies for Left Atrial Ablation Procedures: A Parallel, Intra-Institutional Comparison of Safety and Feasibility.

BACKGROUND: Head-to-head comparative data for the postoperative care of patients undergoing left atrial ablation procedures are lacking. OBJECTIVE: We sought to investigate complication and readmission rates between patients undergoing same-day (SD) or next-day (ND) discharges for ablative procedures in the left atrium, primarily atrial fibrillation (AF). METHODS: Two electrophysiology centers simultaneously perform left atrial ablations with differing discharge strategies. We identified all patients who underwent left atrial ablation from August 2017 to August 2019 (n = 409) undergoing either SD (n = 210) or ND (n = 199) discharge protocols. We analyzed any clinical events that resulted in procedural abortion, extended hospitalization, or readmission within 72 hours. RESULTS: The primary endpoint of complication and readmission rate was similar between SD and ND discharge (14.3% vs 12.6%, p = 0.665). Rates of complications categorized as major (2.4% vs 3.0%, p = 0. 776) and minor (11.9% vs 9.5%, p = 0.524) were also similar.Multivariable regression modeling revealed no significant correlation between discharge strategy and complication/readmission occurrence (OR 1.565 [0.754 - 3.248], p = 0.23), but a positive association of hypertension and procedure duration (OR 3.428 [1.436 - 8.184], p = 0.006) and (OR 1.01 [1 - 1.019], p = 0.046) respectively. CONCLUSIONS: Left atrial ablation complication and readmission rates were similar between SD and ND discharge practices. Hypertension and procedural duration were associated with increased complication rates irrespective of discharge strategy. These data, which represent the first side-by-side comparison of discharge strategy, suggests same-day discharge is safe and feasible for left atrial ablation procedures.

Outcomes Of Manifest Right Free Wall Accessory Pathway Ablation: Data From A Single Center.

BACKGROUND: Right free wall (RFW) accessory pathways (AP) typically present anatomical challenges to ablation leading to high rates of procedural failure and recovery of AP conduction. METHODS: Patients with a diagnosis of Wolff-Parkinson-White Syndrome (WPW) and a manifest RFW AP undergoing an electrophysiology study (EPS) or an ablation at our center between 01/01/2008 and 08/01/2019 were identified from our databases using diagnosis codes and manual chart review. RESULTS: Twenty-one patients with manifest RFW AP underwent EPS, all of which were targeted for ablation. Single procedure success rate was 19 / 21 (90.5%). Of the 19 successful cases, 4 (17.4%) patients were found to have recurrent right free wall pathway conduction at follow-up and each underwent a successful 2nd procedure (9.5%). Fluoroscopic and 3D electroanatomic mapping software was used in all cases to guide ablation. A 4 mm or 8 mm non-irrigated radiofrequency (RF) ablation catheter was used in 76% of cases while an 8 mm cryo-catheter was used in one case. More than one type of ablation catheter was used in four cases (16%). A steerable sheath was used in 68% of cases. CONCLUSIONS: In a tertiary center, RFW AP ablation has high acute success (>90%) but approximately 21% of patients with initially successful ablation required a 2nd procedure for recurrence of pathway conduction. A combination of a large tip ablation catheter and a steerable sheath were used in most cases.

Prospective evaluation of health status, quality of life and clinical outcomes following implantable defibrillator generator exchange.

BACKGROUND: Little is known about health status and quality of life (QoL) after implantable cardioverter-defibrillator (ICD) generator exchange (GE). METHODS: We prospectively followed patients undergoing first-time ICD GE. Serial assessments of health status were performed by administering the 36-Item Short Form Survey (SF-36). RESULTS: Mean age was 67.5 ± 14.3 years, left ventricle ejection fraction (LVEF) was 36.5% ± 15.0% and over 40% of the cohort had improved LVEF to > 35% at the time of GE. SF-36 scores were significantly worse in physical/general health domains compared to domains of emotional/social well-being ( P < 0.001 for each comparison). Physical health scores were significantly worse among those with medical comorbidities including diabetes, chronic obstructive pulmonary disease and atrial fibrillation. Mean follow-up was 1.6 ± 0.5 years after GE. Overall SF-36 scores remained stable across all domains during follow-up. Survival at 3 years post-GE was estimated at 80%. Five patients died during follow-up and most deaths were adjudicated as non-arrhythmic in origin. Four patients experienced appropriate ICD shocks after GE, three of whom had LVEF which remains impaired LVEF (i.e., < 35%) at the time of GE. CONCLUSION: Patients undergoing ICD GE have significantly worse physical health compared to emotional/social well-being, which is associated with the presence of medical comorbidities. In terms of clinical outcomes, the incidence of appropriate shocks after GE among those with improvement in LVEF is very low, and most deaths post-procedure appear to be non-arrhythmic in origin. These data represent an attempt to more fully characterize the spectrum of QoL and clinical outcomes after GE.

Ablation of manifest septal accessory pathways: a single-center experience.

BACKGROUND: Ablation of septal accessory pathways (SAPs) is associated with an increased risk of heart block. Data on outcomes of SAP ablation in adults are limited. OBJECTIVES: To describe outcomes of SAP ablation in our center. METHODS: Patients with Wolff-Parkinson-White syndrome (WPW) undergoing an EP study at our center between January 2008 and August 2019 were identified from our institutional database. Location of the pathway was noted as anteroseptal (AS), midseptal (MS), or posteroseptal (PS). Outcomes of the ablation including success, complication rates, and recurrences were also recorded. RESULTS: Thirty-three patients with SAP underwent 35 EP studies: AS (n = 13), MS (n = 5), and PS (n = 15). Thirty pathways were targeted for ablation, two of which required a 2nd procedure resulting in 32 attempts at ablation in 30 patients. In the remaining 3 patients, SAP did not have malignant features and were not targeted for ablation. Single-procedure success rate was 28/30 (93.33%): 9/10 AS, 5/5 MS, and 14/15 PS ablations. One AS pathway was successfully ablated during a 2nd procedure. Two complications were observed: 1 pericardial effusion in a patient who underwent epicardial mapping and ablation of both PS and right free wall APs. Additionally, transient 2:1 AV block occurred during an MS pathway ablation that recovered during follow-up and did not require permanent pacing procedure. CONCLUSION: In this single-center experience, ablation of manifest SAP was associated with high success rates and low complication rates. No instances of permanent heart block requiring pacing occurred.

A Predictive Model for the Long-Term Electrical Performance of a Leadless Transcatheter Pacemaker.

OBJECTIVES: This study sought to formulate a predictive model for describing the long-term electrical performance of Micra (Medtronic, Mounds View, Minnesota). BACKGROUND: The Micra leadless pacemaker is an alternative ventricular pacing option that avoids the pitfalls of transvenous leads. However, well-defined metrics to predict the long-term electrical performance of the device are lacking. METHODS: We identified all patients who underwent successful Micra implantation enrolled in the investigational device exemption study, continued access study, or post-approval registry with complete 1-year post-implantation data or system revision due to elevated thresholds (N = 1,843). The analysis endpoint was an elevated pacing capture threshold (PCT) at ≥12 months post-implantation, defined as ≥2.0 V at 0.24 ms or an increase of ≥1.5 V from implantation or need for system revision due to elevated thresholds at ≤12 months post-implantation. We evaluated for univariate and multivariate associations between patient and device characteristics at implantation and for elevated thresholds at 12 months. RESULTS: Among the total cohort, 75 patients (4.1%) had elevated thresholds at 12 months; of these, 13 required system revisions. Predictors associated with elevated thresholds in univariate analysis included the total number of deployments (excluded from the multivariable model), impedance and PCT at implantation, male sex, history of diabetes, and ischemic cardiomyopathy. Multivariable regression modeling found that male sex, history of diabetes, implantation PCT of ≥2 V, and impedance of <800 Ω were independent predictors of elevated PCT at 12 months (all p < 0.05). CONCLUSION: A history of diabetes, male sex, elevated PCT, and low impedance at implantation were independent predictors of elevated thresholds at 12 months. These metrics represent the foundation of a simple tool to aid in procedural decision making.

Relationship between device-detected burden and duration of atrial fibrillation and risk of ischemic stroke.

BACKGROUND: Wider availability of continuous rhythm monitoring has made feasible the incorporation of metrics of atrial fibrillation (AF) burden and duration into the decision to initiate anticoagulation. However, the relationship between thresholds of burden and duration and underlying risk factors at which anticoagulation should be considered remains unclear. OBJECTIVE: The purpose of this study was to evaluate the relationships of these metrics with each other and the outcome of stroke/transient ischemic attack (TIA). METHODS: We identified patients with cardiovascular implantable electronic devices (CIEDs) with atrial leads who had at least 1 interrogation in 2016 demonstrating nonpermanent AF and were not receiving oral anticoagulation (OAC). We evaluated the relationship between burden (ie, percentage of time spent in AF), the longest single episode of AF, and risk factors (ie, CHA2DS2-VASc score) in predicting risk of stroke/TIA. RESULTS: The study included 384 patients with mean follow-up of 3.2 ± 0.8 years and incidence of stroke/TIA of 14.8% during follow-up (∼4.6% per year). The burden of AF and the duration of longest episode demonstrated a significant positive correlation to each other but not CHA2DS2-VASc score. Importantly, although the CHA2DS2-VASc score was predictive of stroke/TIA, neither burden nor duration was associated with stroke/TIA. CONCLUSION: Among patients with CIED-detected AF not receiving OAC, the amount of AF (measured by either burden or duration) does not seem to significantly impact stroke risk, whereas CHA2DS2-VASc score does. These data suggest that among patients with CIED-detected AF, once AF occurs, stroke risk seems to be predominantly driven by underlying risk factors.

Life cycle management of Micra transcatheter pacing system: Data from a high-volume center.

BACKGROUND: Data on the management of Micra transcatheter pacing system (TPS) at the time of an upgrade or during battery depletion is limited. OBJECTIVE: We sought to evaluate the management patterns of patients implanted with a Micra TPS during long-term follow-up. METHODS: We retrospectively identified patients who underwent Micra implantation from April 2014 to November 2019. We identified patients who underwent extraction (n = 11) or had an abandoned Micra (n = 12). RESULTS: We identified 302 patients who received a Micra during the period of the study. Mean age was 72.7 ± 15.4 years, 54.6% were men, and left ventricular ejection fraction was 51.9 ± 5.2%. Mean follow-up was 1105.5 ± 529.3 days. Procedural complications included pericardial tamponade (n = 1) treated with pericardiocentesis, significant rise in thresholds (n = 6) treated with reimplantation (n = 4), and major groin complications (n = 2). Indications for extraction included an upgrade to cardiac resynchronization therapy (CRT) device (n = 3), bridging after extraction of an infected transvenous system (n = 3), elevated thresholds (n = 3), and non-Micra-related bacteremia (n = 2). The median time from implantation to extraction was 78 days (interquartile range: 14-113 days), with the longest extraction occurring at 1442 days. All extractions were successful, with no procedural or long-term complications. Indications for abandonment included the need for CRT (n = 6), battery depletion (n = 2), increasing thresholds/failure to capture (n = 3), and pacemaker syndrome (n = 1). All procedures were successful, with no procedural or long-term complications. CONCLUSION: In this large single-center study, 6% of patients implanted with a Micra required a system modification during long-term follow-up, most commonly due to the requirement for CRT pacing. These patients were managed successfully with extraction or abandonment.

Histopathologic and Ultrastructural Findings in Human Myocardium After Stereotactic Body Radiation Therapy for Recalcitrant Ventricular Tachycardia.

BACKGROUND: Stereotactic body radiation therapy (SBRT) is a novel treatment for refractory ventricular tachycardia (VT). While outcomes have been described in small studies, histological findings after SBRT for VT are unknown. METHODS: We identified 4 explanted hearts in the context of transplant that received prior SBRT as part of an 11-patient compassionate use series at our institution. Clinical VTs and computed tomography-defined target volume areas of SBRT were correlated to the anatomic specimens. Gross pathological, histological, and ultrastructural examination of tissue in the target area of SBRT was performed. RESULTS: All 4 patients had nonischemic cardiomyopathy, and 3 had left ventricular assist devices. In all cases, patients had recurrent sustained VT and had failed multiple antiarrhythmics and radiofrequency ablations. Four patients underwent 5 total SBRT therapy sessions with 25-Gy single-fraction dose delivered to the area of culprit scar. The time from SBRT to explant ranged from 12 to 250 days. Histopathologic features following radiation were comparable in all patients and were characterized by areas of subendocardial necrosis surrounded by a rim of fibrosis. In 1 patient, the surrounding myocardium showed cytoplasmic vacuolization in myocytes and in another patchy interstitial fibrosis. Vascular changes consisted of myointimal thickening with prominence of endothelial cells. Electron microscopy of myocardium showed irregular, convoluted intercalated disc regions, loss of contractile elements with disrupted and haphazardly arranged myofibrils, and edematous mitochondria with loss of cisternae. CONCLUSIONS: Here, we report the first series of findings in human tissue in 4 patients after SBRT. Histopathologic features were consistent across all 4 patients and were indicative of cell injury, death, and to a lesser extent, fibrosis. Electron microscopy demonstrated features consistent with acute injury. These specimens provide radiobiological mechanisms of acute cellular injury during SBRT for VT, which may have an antiarrhythmic effect before the onset of fibrosis.

Cardiac implantable electronic devices in patients with persistent left superior vena cava-A single center experience.

BACKGROUND: There are limited data on cardiac implantable electronic device implantation (CIED) in patients with persistent left superior vena cava (PLSVC). OBJECTIVE: To describe the outcomes of implanting CIEDs with a focus on cardiac resynchronization therapy (CRT) in patients with PLSVC. METHODS: We identified all patients with a PLSVC that underwent CIED implantation from December 2008 until February 2019 at our institution by querying the electronic medical record (n = 34). We then identified controls in a 3:1 fashion (n = 102) by matching on device type (CRT vs non-CRT). Procedure success, complications, fluoroscopy and procedural time were recorded. Outcomes were compared using a two-way analysis of variance test and conditional regression modeling for continuous and categorical variables, respectively. RESULTS: A total of 34 patients with PLSVC underwent 38 procedures. Four patients underwent dual chamber system implantation followed by a subsequent upgrade to CRT. Thirteen patients underwent CRT implantation: one was implanted via the right subclavian while the rest were implanted via the PLSVC. Left ventricular (P = .06). Procedure and fluoroscopy times were significantly higher in the PLSVC as compared with the control group (97.7 vs 66.1 minute, P < .001 and 18.1 minute vs 8.7 minutes, P = .005, respectively). CONCLUSION: CIED implant in patients with PLSVC is feasible but technically more challenging and appears to be associated with higher risk of right ventricular lead dislodgment.

The Effect and Relationship of Frailty Indices on Survival After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to evaluate the ability of individual markers of frailty to predict outcomes after transcatheter aortic valve replacement (TAVR) and of their discriminatory value in different age groups. BACKGROUND: Appropriate patient selection for TAVR remains a dilemma, especially among the most elderly and potentially frail. METHODS: The study evaluated patients ≥65 years of age in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, linked to Centers for Medicare and Medicaid administrative claims data, receiving elective TAVR from November 2011 to June 2016 (n = 36,242). Indices of frailty included anemia, albumin level, and 5-m walk speed. We performed Cox proportional hazards regression for 30-day and 1-year mortality, adjusting for risk factors known to be predictive of 30-day mortality in the Transcatheter Valve Therapy registry, as well as survival analysis. RESULTS: These indices are independently associated with mortality at 30 days and 1 year and provide incremental value in risk stratification for mortality, with low albumin providing the largest value (hazard ratio: 1.52). Those with low albumin and slower walking speed had longer lengths of stay and higher rates of bleeding and readmission (p < 0.001). Those with anemia also had higher rates of bleeding, readmission, and subsequent myocardial infarction (p < 0.001). CONCLUSIONS: This represents the largest study to date of the role of frailty indices after TAVR, further facilitating robust modeling and adjusting for a large number of confounders. These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR.

Comparison of echocardiographic and fluoroscopic sizing of the left atrial appendage prior to percutaneous closure.

PURPOSE: Sizing of the left atrial appendage (LAA) ostium prior to occlusion (LAAO) is routinely performed with transesophageal echocardiography (TEE). We sought to compare the utility of sizing via fluoroscopy to TEE for percutaneous LAAO. METHODS: We retrospectively evaluated all patients undergoing percutaneous LAAO at our institution from April 2015 through January 2018 (n = 195). We evaluated baseline characteristics, maximum measured ostium size (for both TEE and fluoroscopy), and differences in measured size to device size for both techniques. RESULTS: Of the total cohort, 185 (95%) had both intraoperative TEE and fluoroscopic images available for analysis and were included in the final analysis. The mean age was 74 years and 64% were male. Hypertension was present in 89%, diabetes in 30%, and stroke in 32% of patients. The mean ejection fraction was 51%. The most common LAA morphology was "wind sock" (52%). Measured ostial diameter on fluoroscopy was larger compared with TEE (2.04 ± 3.43 mm larger on fluoroscopy, p < 0.001). Ostium diameter on TEE was more closely correlated to the size of the device implanted compared with fluoroscopy (0.76 vs. 0.61, p = 0.001). CONCLUSIONS: Fluoroscopy results in larger estimated LAA ostium diameter compared with TEE. Despite this, TEE was more strongly correlated to operator choice in device sizing, which may reflect practice patterns. Because compression of the ostium on the device is necessary for long-term procedural success, under-sizing may lead to a higher rate of leaks. Prospective evaluation of the utility of routine fluoroscopic sizing compared with TEE is warranted.

The Safety and Feasibility of Same-Day Discharge After Implantation of MICRA Transcatheter Leadless Pacemaker System.

BACKGROUND: Data suggests that same day discharge after implantation of trans-venous pacemakers is safe and feasible. We sought to determine whether same day discharge was feasible and safe following implantation of Medtronic MICRA leadless pacemakers. METHODS: We retrospectively identified all patients undergoing MICRA placement at our institution between April 2014 to August 2018 (n=167). Patients were stratified into two groups: those discharged on the same day as their procedure (SD, n=25), and those observed for at least one night in the hospital (HD, n=142). The primary endpoint included a composite of major complications including: access site complications, new pericardial effusion, device dislodgement, and need for device revision up to approximately 45 days of follow up. RESULTS: SD and HD had similar age (75±13 vs. 75±13 years, p=0.923), prevalence of male sex (49 vs. 44%, p=0.669), and frequency of high-grade heart block as an indication for pacing (38 vs. 32%, p=0.596). There were more Caucasians in the SD group (72 vs. 66%, p=0.038). The rate of the composite endpoint was statistically non-significantly higher in the HD group (3.5% vs. 0.0%, p=1.00). The rates of each individual components comprising the composite endpoint were similar between groups. CONCLUSIONS: Our data suggest that in appropriately selected patients, same day discharge can occur safely following Micra leadless pacemaker implantation.

Development of a Risk Score to Predict New Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes. METHODS: All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367). RESULTS: Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p < 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing >15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p < 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p < 0.001), which was similar to its performance in the derivation cohort. CONCLUSIONS: A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR.