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Showing 10 of 107969 citations.

Abstract 4147907: Validation of PAINESD Score to Predict Outcomes of Catheter ablation of Structural Ventricular Tachycardia
Woelber, Tiffany, Futela, Pragyat , Poddar, Aastha, Heybati, Kiyan , Pradeep, Aishwarya , Amin, Hina , Deshmukh, Abhishek , Karikalan, Suganya Arunachalam , Prasitlumkum, Narut , Deshmukh, Abhishek , Kowlgi, Gurukripa N.

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147907 Get It

Background: PAINESD score was established as a predictor of periprocedural acute hemodynamic instability, long-term mortality and heart failure among patients undergoing catheter ablation for ventricular tachycardia (VT-CA). Objective: To assess the validity of PAINESD score and compare outcomes of high-risk patients undergoing catheter ablation for ventricular tachycardia (VT) with and without mechanical circulatory support (MCS) use during procedure. Methods: We conducted an observational dual-center study of consecutive patients with SHD undergoing VT-CA over a decade (2012-2022). The PAINESD score, based on 7 variables (COPD, age >60 years, general anesthesia, ischemic cardiomyopathy, NYHA class III or IV, ejection fraction <25%, VT storm, and diabetes mellitus), was calculated and categorized into low risk (<10), intermediate risk (10-16), and high risk (>16) as previously reported. Two survival analyses were performed to compare outcomes between different groups: one using all-cause mortality or heart transplant as the event, and another using recurrent or repeat ablation as the event. Multivariable Cox proportional hazards regression models were used to calculate hazard ratios for each PAINESD category and to determine the hazard ratio for the use of MCS among high-risk patients. Results: We found that between 2012 to 2022, 559 ablations were performed on 441 patients. There were 296 (53%), 182 (32.6%) and 81(14.5%) patients in low, medium, and high risk. Using low risk as reference, aHR for medium risk was 2.1 (1.24-3.7; p=0.006) and for high risk was 4.6(2.54-8.3; p <0.001). Among patients with high PAINESD score (n=81), 5 patients (6.2%) required MCS (Intra-arterial balloon pump (IABP)=1, ECMO only=1, ECMO+IABP=1, bypass=2). 4/5 (80%) patients on MCS stayed on them post procedure, except one patient on IABP. In this cohort, there was no difference between patients with and without MCS in primary outcome [aHR= 1.6 (0.48-5.4); p=0.43] and in secondary OUTCOME [1.29 (0.3-5.5; p=0.735)]. Conclusion: PAINESD was a significant predictor of mortality or heart failure, but it did not help in prediction of recurrence of VT, or repeat VT-CA.
Abstract 4147904: Chronotropic Incompetence in Amyloid Cardiac Disease: A Marker of Severity?
Aviles, Laura Ortega, Grogan, Martha , Allison, Thomas G. , Santos-Patarroyo, Sebastián

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

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Background: Cardiac amyloidosis is a rapidly progressing and severe condition leading to heart failure and reduced quality of life. Amyloid deposits impair both chronotropic and pumping functions of the heart. The Cardiopulmonary Exercise Test (CPET) is a vital tool in assessing the severity and progression of this disease. Aims: This study aims to investigate the differences in chronotropic function associated with the stages of heart failure in patients with cardiac amyloidosis and outcomes. Methods: A retrospective cohort study was conducted involving 194 patients diagnosed with cardiac amyloidosis who underwent at least one CPET from February 2010 to February 2024. Medical records were reviewed for data on the type of amyloidosis, comorbidities, and CPET results. The cohort was divided into two groups according to the Weber Classification: Weber Class A/B and Weber Class C/D. Patients who had CPET studies post-heart transplant were excluded. Statistical analyses, including Fisher’s exact test and chi-square test, were used. Cox regression model analysis, proportional hazards model for time to event. Adjustment for beta-blocker use was made to assess chronotropic incompetence. A p-value <0.05 was considered significant. Results: Among the 194 patients, 94 were classified as Weber A/B and 100 as Weber C/D. The average age at the time of the stress test was similar between the groups: 62.9 ± 11.7 years for Weber A/B and 62.3 ± 10.7 years for Weber C/D (p=0.087) Table 1 . Chronotropic function, evaluated through CPET, showed significant differences. Heart rate reserve was significantly lower in the Weber C-D group compared to the A-B group (p<0.001). The chronotropic index was also significantly lower in the Weber C-D group Figure 2. Chronotropic incompetence was observed in 43.9% of the Weber A and increased progressively, being significantly more prevalent in the Weber D group (100%) (p<0.001). Additionally, Chronotropic incompetence was strongly associated with the composite outcome of (hospitalization for heart failure and death) HR 1.932 (1.126 -3.313) p =0.0167 (Table 2). Conclusion: CPET assessment of chronotropic function correlates with VO2 parameter evaluated in Weber classification. Patients with higher Weber stages of heart failure in amyloidosis exhibited a higher prevalence of chronotropic incompetence, indicating it could serve as a marker of cardiac function.
Abstract 4147894: Epicardial vs endocardial ablation for ventricular tachycardia: Patient Characteristics, Procedural Factors, and Outcomes
Poddar, Aastha, Futela, Pragyat , Woelber, Tiffany, Heybati, Kiyan , Amin, Hina , Deshmukh, Abhishek , Kowlgi, Gurukripa N. , Prasitlumkum, Narut , Deshmukh, Abhishek

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147894 Get It

Background: Patients undergoing epicardial access for ventricular tachycardia (VT) have a higher rate of complications and VT recurrence post-procedure. Data regarding electrophysiological factors driving the outcomes are scant. Objective: To compare the factors and outcomes associated with epicardial vs endocardial VT ablation. Methods: A single-center, retrospective study of patients undergoing catheter ablation for scar-related VT was conducted. Data collected included demographics, comorbidities, medications, relevant laboratory abnormalities, electrocardiograms, echocardiograms, detailed procedural characteristics, and outcomes. Results: Our cohort of 554 patients had 89 (16.1%) epicardial and 465 (83.9%) endocardial VT ablations. Patients undergoing epicardial ablation had a greater frequency of NICM, and more patients had undergone sympathetic modulation for VT (p < 0.05) but had lesser frequency of valve surgery, and CABG. Epicardial ablation was associated with greater use of both short-term (<3 months) and long-term (>6 months) anti-arrhythmic drugs (AAD) (p<0.01). Epicardial access was obtained by micropuncture or needle-in-needle technique for 22.5% (n=20) of patients. Except for more use of general anesthesia and the lesser usage of drugs for VT induction during epicardial procedures, there were no significant differences. Epicardial ablation had a higher risk of acute complications (<30 days) after the procedure (driven by pericarditis) (25% vs 7.8%, p<0.01). On survival analysis, epicardial access was associated with an increase in VT recurrence and repeat ablation (p<0.01) during a mean follow-up of 1072 days. On multivariate analysis, after adjusting for age, sex and comorbidities, epicardial access was an independent predictor of VT recurrence or repeat ablation [aHR 1.61 (CI: 1.18- 2.2)] Conclusion: Patients undergoing epicardial ablations with fewer comorbidities demonstrated increased AAD usage prior to and after the procedure, and a higher risk of acute complications after the procedure. Epicardial access was an independent predictor of VT recurrence or repeat ablation.
Abstract 4147807: Peak Oxygen Uptake Changes as a Function of Lean Mass After Cardiac Rehabilitation
Elkhatib, Wiaam , Olson, Thomas P.

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147807 Get It

Introduction: Peak oxygen uptake (VO 2 peak), standardized to total body mass (ml/kg/min) is a predictor of morbidity and mortality in cardiovascular disease patients. However, subsets of individuals undergoing exercise based cardiac rehabilitation (CR) show no improvement or reduction in VO 2 peak despite improvement in other functional measures. Hypothesis: Change in peak VO 2 post-CR, adjusted for lean mass rather than total mass better reflects peak VO 2 improvements. Aim : To assess the influence of CR on lean mass and the effect of lean mass compared to total body mass changes on peak VO 2 following CR. Methods: This observational cohort study included adults >18 years old who completed CR between 2015-2022 at Mayo Clinic, Rochester. All patients completed both dual energy X-ray absorptiometry (DXA) and cardiopulmonary exercise testing (CPET) for measurement of body composition (total mass and lean mass) and VO 2 peak pre- and post-CR. Improvement in VO 2 peak was defined as >% increase. Paired t-tests, one-way ANOVA, and descriptive statistics were performed. Results: Of 145 subjects, 81% were male and 63% Caucasian with a mean (SD) age of 62.8±12.6 years, BMI of 30.3±5.7, and 33.4±8.2 of 36 prescribed (92.8%) CR sessions completed. Pre-CR, patients demonstrated absolute VO 2 peak of 1,997.0±693.5 mL/min, relative of 22.1±6.2 mL/kg/min, and relative to lean mass of 35.2±9.6 mL/kg lean/min. After CR, patients demonstrated 1.2±3.1 kg reduction in total mass (p<0.05) and 0.4±1.7 kg increase in lean mass (p<0.05). Post-CR VO 2 peak increased by 17.1±117.0% absolute units (mL/min) (p<0.05), 9.0±16.1 % relative units (mL/kg/min) (p<0.05), and 15.9±111.9% units relative to lean mass (mL/kg lean/min) (p<0.05). Absolute and relative to lean mass units demonstrated greater improvements in VO 2 peak compared to relative units (p<0.05). Dependent on units, 70.3% of patients demonstrated an improvement in absolute VO 2 , 75.2% patients improved relative VO 2 , and 62.8% patients improved VO 2 relative to lean mass. Conclusions: These data demonstrate significant increases in lean mass and VO 2 following CR, with larger improvements reflected in units adjusted for lean mass compared to traditional relative units. In contrast, the largest proportion of patients showed positive improvements in VO 2 peak relative units with the smallest proportion relative to lean mass. These data suggest the reporting methodology for change in VO 2 following CR may impact overall findings.
Abstract 4147752: Agreement of Doppler Flow Velocity Reserve With PET Flow Reserve in Angina Without Obstructive Coronaries
Bois, John P. , Ismayl, Mahmoud , Raphael, Claire E. , Prasad, Abhiram , Chareonthaitawee, Panithaya

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147752 Get It

Background: Angina with no obstructive coronary arteries (ANOCA) is clinically challenging to diagnose and manage. The agreement between Doppler-derived coronary flow reserve (CFR Doppl ) and PET-derived CFR (CFR PET ) in patients with ANOCA remains unclear. Aims: To evaluate the correlation between Doppler- and PET-derived CFR in patients with ANOCA. Methods: We conducted a single-center, retrospective study of adult patients (age ≥18 years) with ANOCA who were referred for evaluation of possible microvascular ischemia with Doppler- and PET-derived CFR at the Mayo Clinic (Rochester, MN) between January 1, 2018, and May 1, 2024. Pearson correlation was used to quantify the association between Doppler- and PET-derived CFR. Agreement between Doppler- and PET-derived CFR was assessed by Bland-Altman analysis using a 2-way mixed effects model with measures of absolute agreement. Results: A total of 66 patients were initially identified, of which 40 were included in the final analysis (66.7% female, median age 58 years [Q1-Q3: 45-66 years]). Median time between PET- and Doppler-derived CFR was 8 days (Q1-Q3: 1-31 days). Median CFR Doppl was 2.75 (IQR: 2.23-3.28) and median CFR PET was 2.50 (IQR: 2.10-3.10). Doppler-derived CFR displayed a wider range than PET-derived CFR (0.8-5.2 vs 1.2-4.0). A strong correlation was found between Doppler- and PET-derived CFR ( r= 0.81; p<0.001). The corresponding Bland-Altman plot showed an overall bias of 0.27±0.56 (intraclass coefficient=0.85; p<0.001). Conclusions: While invasive coronary angiography with CFR Doppl is the gold-standard for the diagnostic evaluation of ANOCA, PET imaging with CFR PET offers an excellent first line non-invasive modality for diagnosis of coronary microvascular dysfunction.
Abstract 4147722: Clinical impact of new severe tricuspid regurgitation following device lead extraction
Mulpuru, Siva K. , Killu, Ammar M. , Siontis, Konstantinos, Cha, Yong‐Mei , Madhavan, Malini , ezzedine, fatima m, Sugrue, Alan , Padang, Ratnasari , Deshmukh, Abhishek , Karikalan, Suganya Arunachalam , O'Shea, Michael, Vemulapalli, Hema Srikanth , Kowlgi, Gurukripa N. , DeSimone, Christopher V. , Masry, Hicham El , Lee, Justin , Deshmukh, Abhishek

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147722 Get It

Introduction: Tricuspid regurgitation (TR) is a common complication of right ventricle lead extraction (RVLE) in 5 to 10% of cases. This study aims to identify clinical outcomes such as predictors of heart failure hospitalization, need for tricuspid valve intervention, and death among patients with new severe TR after device lead removal (DLR). Methods: Patients who underwent DLR (pacemaker/ICD) between 3/1997 and 3/2024 were identified. Those who had an echocardiogram before and after RVLE with evidence of new severe TR were included. Cox univariable regression controlling for current age was used to assess association with death. Prentice Williams Peterson total time (PWPTT) Cox univariable regression was used to determine the rate of heart failure hospitalization up to three events per subject. Bivariable cox regression was used to control for ejection fraction for ICD and coil removal. Analysis was conducted using Stata IC16. Results: We identified 2,122 people who underwent RVLE, of whom 90 (4.24%) developed new severe TR and were included in the analysis. There were 68 hospitalizations among 38 people at a median of 2 years following lead extraction (IQR 0.57 to 4.5 years). The rate of hospitalization was 11.60 [9.14 to 14.71] per 100 person-years. Removal of an ICD was associated with increased hospitalization (HR 5.48 p<0.001) but not mortality (HR 1.21, p=0.707). Removal of a single coil ICD lead was associated with increased hospitalization rate (HR 3.01, p=0.031) but not mortality (HR =0.51, p=0.380). Removal of dual coil ICD lead was associated with more than a tenfold increase in hospitalization rate (HR 11.55, p=0.001) and four times the mortality rate (HR 4.05, p=0.031) (Figures 1&2). The presence of an abandoned (pacemaker/ICD) lead was associated with increased hospitalization (HR 5.75, p=0.004) and mortality (HR4.95, p=0.034). There was no change in hospitalization rate following tricuspid valve replacement (HR 1.33, p=0.716, n=18). Conclusion: Among people with new severe TR following DLR, the characteristics of the leads are strongly correlated with morbidity and mortality.
Abstract 4147597: Venoarterial Extracorporeal Membrane Oxygenation With and Without Left Ventricular Unloading in Patients With Cardiac Arrest
Wardhere, Abdirahman , Mohamoud, Abdilahi , abdallah, nadhem, Ismayl, Mahmoud , Goldsweig, Andrew M.

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147597 Get It

Background: Extracorporeal cardiopulmonary resuscitation (ECPR) using venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a promising strategy for refractory cardiac arrest. However, the role of left ventricular (LV) unloading during ECPR remains uncertain. Methods: We queried the United States National Inpatient Sample (2016-2021) to identify adult patients with out-of-hospital (OHCA) and in-hospital cardiac arrest (IHCA) who received ECPR. Patients were stratified based on the use of either VA-ECMO only or VA-ECMO with intra-aortic balloon pump (IABP) or VA-ECMO with Impella (ECPELLA) for ventricular unloading. Multivariable logistic regression was used to compare in-hospital outcomes between the groups. Results: Among 6,915 patients receiving ECPR, VA-ECMO alone was used in 5,145 (74.4%), VA-ECMO-IABP in 809 (11.7%), and ECPELLA in 961 (13.9%). The LV unloading groups more frequently presented with ventricular tachycardia/fibrillation (61.1% and 72.4% vs. 43.9%, both p<0.01), while the VA-ECMO only group more often presented with pulseless electrical activity/asystole (56.1% vs. 38.9% and 27.6%, both p<0.01). In IHCA patients, ECPELLA was associated with 50% lower odds of in-hospital mortality compared to VA-ECMO alone (adjusted odds ratio [aOR] 0.50, 95% CI 0.31-0.81, p<0.01). No significant difference was found in OHCA patients. VA-ECMO-IABP was not associated with a mortality benefit vs. VA-ECMO alone in either OHCA or IHCA (Figure 1). Cardiovascular complications were significantly higher in both LV unloading groups compared to the VA-ECMO only group in OHCA subgroup (90% and 95% vs. 73.3%, both p<0.01) while IHCA subgroup only showed higher significant rates in ECPELLA compared to VA-ECMO alone (89.3% vs. 81%, p=0.04) (Figure 2). After adjustment for potential confounders, VA-ECMO-IABP (aOR 2.79, 95% CI 1.02-7.60, p=0.04) and ECPELLA (aOR 6.92, 95% CI 2.09-22.94, p<0.01) were associated with significantly higher odds of cardiovascular complications compared to VA-ECMO alone among OHCA patients, but not among IHCA patient. There were no statistically significant differences in neurologic, renal, and hematologic complications between the three groups in either OHCA or IHCA patients (Figure 3). Conclusion: In this nationwide study, LV unloading with ECPELLA was associated with improved survival in IHCA patients but not in OHCA patients compared to VA-ECMO alone. The addition of IABP to VA-ECMO was not associated with a mortality benefit.
Abstract 4147592: Acute Pressor, Chronotropic and Adrenergic Effects of Adderall - A Randomized Double-Blind Placebo Controlled Crossover Study
Somers, Kiran R. , Covassin, Naima , Bukartyk, Jan , Rajendran, Aiswarya , Svatikova, Anna , Bock, Joshua M.

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147592 Get It

Introduction: Adderall, the brand name for a combination of dextroamphetamine and amphetamine salts, is used to treat attention deficit disorder and narcolepsy, but is widely abused for improving cognitive function and alertness in absence of a medical indication. While little is known of its acute cardiovascular (CV) physiologic effects, Adderall has been linked to acute CV events (myocardial infarction, tachyarrhythmias, heart failure, Takotsubo cardiomyopathy and sudden death) and to long term CV consequences including hypertension and arterial disease. Aim: To examine the acute CV responses to Adderall in healthy subjects not on stimulant therapy in a randomized double-blind placebo-controlled crossover study. (CT.gov NCT02979327) Methods: Thirty subjects were randomized to 25 mg Adderall versus placebo. We measured supine resting blood pressure (BP), heart rate (HR), and plasma catecholamines, before and 3 hours after consuming Adderall or placebo. Results: Twenty-nine subjects (16 females; aged 25±5 yrs) completed both Adderall and placebo conditions, with a median of 10 days between visits. Systolic BP (SBP) increased from 112±10 mmHg to 127±11 mmHg after use of Adderall but was unchanged before vs after placebo drug intake (112±8 mmHg and 112±9 mmHg respectively; group by time interaction p<0.01). Diastolic BP and mean BP increased by 6.8 mmHg and 8.5 mmHg respectively and HR increased by 7.3 beats/min with Adderall, but they did not change with placebo (p<0.01). Plasma norepinephrine increased from 217±79 pg/ml before to 323±105 pg/ml after Adderall but was unchanged after placebo (p<0.05) (Figure 1). Conclusions: Healthy subjects consuming a modest dose of Adderall manifest striking increases in BP, HR and sympathetic activation, even during supine rest. These findings may have important mechanistic implications for understanding acute CV events and long-term risk of CV disease associated with stimulant medications.
Abstract 4147575: Outcomes of Utilizing Sodium Glucose Transporter Inhibitors Following Acute Myocardial Infarction: A Comprehensive Meta-Analysis
Suppah, Mustafa , Desouki, Mariam, Ali, Mohammed Salah, Mohamed, Alaa , Keshk, M., Saugstad, Austin , Naik, Hursh, Bellamkonda, Pallavi, Keshk, Menna, Moradi, Ali, Alsidawi, Said

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147575 Get It

Introduction: Acute myocardial infarction (AMI) remains a leading cause of morbidity and mortality worldwide. In the quest for improved therapeutic strategies, the addition of Sodium Glucose Transporter Inhibitors (SGLTis) to the treatment regimen has garnered considerable attention. This meta-analysis endeavors to shed light on the efficacy of SGLTis in short-term cardio-renal protection post-AMI. By synthesizing evidence from diverse studies. Methods: Adhering to the PRISMA guidelines, a meticulous systematic review and meta-analysis were conducted. Comprehensive literature searches across PubMed, Web of Science, Scopes, and Google Scholar were performed. Inclusion criteria comprised four Randomized Controlled Trials (RCTs), one retrospective cohort, and one observational study, investigating the effects of SGLTis versus placebo on AMI patients, irrespective of diabetic status. Our analysis included the following outcomes: acute kidney injury, all-cause death, cardiovascular mortality, cardiac death, composite of cardiovascular death/hospitalization for heart failure, and NT-proBNP levels. Results: Our analysis encompassed six scientific articles involving 7238 patients. SGLTIs exhibited a notable favorable effect solely on acute kidney injury (P value=0.001, 95% CI [0.46-0.82]). Conversely, no significant benefit was observed in other short-term outcomes, including all-cause death, cardiovascular mortality, cardiac death, composite of cardiovascular death/hospitalization for heart failure, and NT-proBNP levels. These results align with previous studies suggesting the renal protective effects of SGLTIs but highlight the need for further research to clarify their overall cardiovascular benefits in AMI patients. Conclusion: Incorporating SGLTis into the therapeutic armamentarium of AMI patients, irrespective of diabetic status, demonstrated a discernible advantage solely concerning acute kidney injury. However, no appreciable benefit was discerned across other assessed metrics. These findings underscore the need for further exploration and tailored therapeutic strategies in the management of post-AMI patients.
Abstract 4147545: Adverse Events with Pulsed Field Ablation - A Review of the Food and Drug Administration’s Manufacturer and User Facility Device Experience Database
Cooper, Julie , Zagrodzky, William , Zagrodzky, Jason , Omotoye, Samuel, Kaplan, Andrew , Bunch, T. Jared , Daniels, James , Sardana, Mayank , Link, Mark S.

Mayo Clinic

Circulation | November 14, 2024 | Volume: 150 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.150.suppl_1.4147545 Get It

Introduction: Pulsed field ablation (PFA) is an adaptation of direct current ablation first used for catheter ablation in the 1980s. Expectations of a reduced risk profile led to the current resurgence in investment and interest in the technology as a potential alternative energy source for ablations to treat atrial fibrillation (AF). However, reports of adverse events, including new risks, are increasing. Research Question: How many adverse effects are reported with the use of newly available PFA systems? Aims: Quantify and describe the adverse events from PFA reported to date in the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods: We searched the U.S. FDA’s MAUDE database for all reports filed with the code “QZI”, which is the product code for PFA systems created with the first FDA approvals in February 2024. All reports from inception through April 2024 (a total of 3 months) were included in this review. Per manufacturer presentation in May 2024, approximately 1000 cases utilizing PFA had been captured in a post-market registry of the predominant commercially used technology, but the exact number of cases can not be determined from MAUDE data. Results: A total of 217 adverse events were reported over the first 3 months of US approval, with 91 of these considered patient injuries. These injuries included 10 cases of cardiac tamponade, 7 reports of postoperative arrhythmia, 6 instances of device-related tissue entrapment, 5 cases of hemolysis with impaired renal function, 5 cases of stroke or TIA, including both embolic and hemorrhagic, 3 cases of intraoperative heart block, 2 coronary spasms, and 2 cases of intraoperative ST elevation. (Figure) Of the 91 reported patient safety events, 46 required hospitalization, 13 cases required temporary pacing, 11 required pericardiocentesis, 4 required dialysis, 4 required cardiothoracic surgery, and 2 required cardioversion. Conclusions: A number of adverse events have been reported to the MAUDE database in the first 3 months of FDA approval of PFA. The cardiac electrophysiology community should remain vigilant to ensure that the benefit-risk profile remains acceptable for patient safety.