Arizona Heart Institute

For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-relatedbleeding, was tested for superiority. Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval [CI], -0.8 to 2.6; P<0.001 for noninferiority). Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority). Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).

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.

Background: Optimizing lipid-lowering therapy (LLT) use is foundational to reduce atherosclerotic cardiovascular disease (ASCVD) risk, especially among patients who have already experienced an ASCVD event. This study aimed to evaluate the patterns of LLT intensification and LDL-C testing within 12 months following an ASCVD event in US patients. Methods: Adults who experienced an ASCVD event (acute coronary syndrome, coronary revascularization, stable angina, ischemic stroke, transient ischemic attack, or peripheral arterial disease) between January 1, 2016 and December 31, 2022 in the IQVIA Longitudinal Access and Adjudication Data were included. The first instance of LLT intensification after the event was defined as an increase from a low-moderate to high intensity statin, or the initiation of statins, ezetimibe, PCSK9i, or bempedoic acid in addition to a baseline LLT regimen that did not include these medications. Baseline medication use was defined during 6 months before the ASCVD event. Results: Among 6,028,573 patients who had an eligible ASCVD event (mean age: 63.6 years, 51.5% male), 53.9% were not taking any LLT and 43.2% were taking statins only (low-moderate intensity: 26.7%; high intensity: 16.4%) during baseline. Within 1, 3, and 12 months after the event, 16.3%, 21.3%, and 30.0% of patients intensified LLT, respectively. Among patients who intensified LLT within 12 months (n= 1,820,246), the most commonly observed intensification was from no LLT use at baseline to low-moderate (29.0%) or high-intensity statins (43.5%), followed by intensification from low-moderate to high-intensity statins (20.3%). LDL-C values at baseline were available in a subset of 10.7% of patients, with the median being 95 mg/dL (78.9% ≥70 mg/dL). LDL-C values were observed in 17.7% of patients within 12 months after the ASCVD event, with the median being 84 mg/dL (68.3% ≥70 mg/dL). Conclusions: Within 12 months after an ASCVD event, only about one-third of patients intensified LLT and two-thirds did not achieve guideline-recommended LDL-C levels. The results highlight a missed opportunity to reduce recurrent ASCVD events. Future effort is warranted to address the clinical inertia that may be contributing to this unmet need.

Abstract Patient Barriers to Genetic Counseling Background: Access to genetic counseling is becoming more important as new targeted drugs are developed and as recommendations for testing for hereditary cancer syndromes expands. Yet, significant barriers hinder patients’ access to these services leading to a certain percentage of patients declining a genetic counseling referral (Ochoa, O’Neill). Among one of the more often cited reasons for declining genetic counseling is the cost of the consultation when it is not covered by insurance or a patient is uninsured. This potentially limits patient treatment options and can result in a missed opportunity to identify at-risk relatives. There is scant data documenting why women do not accept genetic counseling referrals and our study sought to better identify these potential barriers. In doing so we hope to enable healthcare providers and policymakers to develop strategies to ensure equitable access to these crucial services. Methods: Breast cancer patients for whom a genetic counseling referral was placed and who self-declared the inability to pay our Cancer Center’s genetic counseling fee ($126) were approached about filling out an anonymous survey regarding their reasons for declining. The survey queried, in addition to cost, other patient-related barriers to genetic testing. The survey also captured the number of first-degree relatives who might be affected by an actionable pathogenic variant. After patients were consented and completed the survey, genetic testing, paid for by the study, was offered. Results: To date, 13 patients were approached about the study and 10 patients (77%) agreed to participate, were consented and filled out surveys. Women could choose more than one reason for declining a genetic counseling referral but the most prevalent reasons cited were cost (10), worried there is nothing to be done about inherited cancers (3), concern about genetic material being taken and/or results being used against them (2), too many appointments (2). Of these 10, all (100%) elected to proceed with genetic counseling and all 10 (100%) elected to proceed with genetic testing. Two of the 10 patients (20%) tested were found to have actionable pathogenic variants (one in BRCA2 and one in CHEK2) potentially impacting 13 adult first-degree relatives. Conclusion: These preliminary findings underscore the importance of access to genetic counseling in order to facilitate appropriate genetic testing. The identification of actionable genetic mutations allows for early detection, timely interventions, and tailored management plans, ultimately leading to improved patient outcomes. By identifying cost as the most often cited reason for declining genetic counseling, healthcare providers and policymakers can develop strategies such as the implementation of financial assistance programs and universal insurance coverage for genetic counseling services in order to alleviate the financial burden and ensure equitable access to these crucial services.

To explore key management principles and outcomes following surgical intervention for spontaneous CSF leaks of the lateral skull base. Outcomes following surgery for spontaneous CSF leaks of the lateral skull base depend on the surgical approach utilized. The approach reported most frequently in the literature is currently the middle fossa approach. Mean leak recurrence rates, regardless of approach, were approximately 6%. The lowest leak recurrence rates were associated with the combined middle cranial fossa-transmastoid approach. A multilayer closure was employed in all of the reviewed investigations, but the choice of reconstructive material did not significantly affect outcomes. Direct surgical complications rates, overall, were low at less than 2%. Meningitis, intracranial hemorrhage, and perioperative seizure activity were only rarely encountered. A concomitant diagnosis of idiopathic intracranial hypertension was found to be associated with increased rates of leak recurrence and sequential leak development at other skull base sites. Postoperative management of patients with spontaneous CSF leaks of the lateral skull base has unique challenges. Observation of key treatment principles can lead to good outcomes and limit morbidity. A high index of suspicion should exist for concomitant idiopathic intracranial hypertension.