Arizona Heart Hospital

BackgroundPulmonary vein isolation (PVI) is the cornerstone therapy for symptomatic drug‐refractory atrial fibrillation yet is not curative in a large segment of patients. Focal and rotational drivers are proposed to be involved in atrial fibrillation mechanisms but their ablation has produced variable outcomes. REAFFIRM (The Randomized Evaluation of Atrial Fibrillation Treatment with Focal Impulse and Rotor Modulation Guided Procedures) trial (NCT‐02274857) objective was to compare the safety and effectiveness of conventional ablation with and without Focal Impulse and Rotor Modulated (FIRM) ablation, guided by global basket mapping, for the treatment of persistent atrial fibrillation.MethodsThree hundred seventy‐five patients were enrolled and randomized at 18 centers. The Intent‐to‐Treat population consisted of 350 patients (171 FIRM, 179 Conventional). Primary effectiveness was defined as single procedure freedom from atrial fibrillation/atrial tachycardia recurrence at 3 to 12 months post index procedure.ResultsThree hundred twenty‐four patients completed the 12‐month follow‐up. Patients in the FIRM arm had a larger left atrium (P <0.01). Primary effectiveness at 3 to 12 months was 69.3% in FIRM and 67.5% in Conventional (NS), with no difference in ablation procedure time or safety. A subset of patients (41% FIRM, 49% Conventional) received extra ablation. Primary effectiveness in the on‐treatment subgroups was 65% PVI‐only, 69.6% PVI +extra, 77.7% FIRM+ PVI‐only, and 57.7% FIRM+ PVI +extra (P=0.09).ConclusionsIntention‐to‐treat analysis failed to provide evidence for the superiority of adding ablation of focal or rotational sites to conventional ablation.RegistrationURL: https://clinicaltrials.gov; Unique Identifier: NCT‐02274857.

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.

Retropharyngeal carotid artery occlusive disease presents a formidable challenge for surgeons due to its anatomic location and increased potential for complications. Conventional treatments, including open revascularization and transfemoral stenting, often face limitations. Transcarotid artery revascularization (TCAR) has offered a promising alternative, integrating a hybrid surgical and endovascular approach. We present a case of an elderly patient with severe symptomatic stenosis of a retropharyngeal carotid artery treated with TCAR. We review the potential injuries reported with the use of transfemoral stenting and endarterectomy in this setting and suggest that TCAR may be a safer modality for its treatment.

Abstract Sex determination in reptiles is important for implementing appropriate husbandry, successful pairing for breeding programs, and reproductive medical care. In reptile species that are not sexually dimorphic, accuracy in sex determination is dependent upon methods other than physical observation. Preferred sexing techniques should be quick, noninvasive, and reliable, and they should be able to be performed by veterinarians with a broad range of reptile experience. Vast anatomical differences among reptiles make the efficacy of these techniques highly variable between species. This study evaluated hemipenis contrast radiography and computed tomography techniques, previously described in other Heloderma species, to determine reliability in sexing 23 Gila monsters (Heloderma suspectum). The results were compared to the sex determined by coelomic ultrasound, which indicated that there were 8 females and 15 males. Identification of hemipenes in males was shown in 1/15 (7%) by contrast radiography and 9/15 (60%) by hemipenis contrast computed tomography. Outline of the cloacal rim in females was seen in 100% (8/8) by contrast radiography and 100% (8/8) by contrast computed tomography. Our findings suggest that contrast radiography and computed tomography are not reliable methods for sex determination in Gila monsters, and that coelomic ultrasound is currently the most reliable, noninvasive technique for this species.

Following the development of permanent transvenous cardiac pacing in the 1960s, the costs of pacemakers quickly led to their reuse in both developed countries and in low-and middle-income countries (LMIC). Legal, ethical, and industrial factors gradually resulted in the termination of reuse in developed countries. Without health care budgets to pay for costly pacemaker technologies, nongovernmental organizations (NGOs), and other groups have provided support to physicians and hospitals treating patients with heart block in LMICs. Multiple other academic and private groups have also assisted such patients in LMICs. Pacemaker companies have provided physicians and hospitals with new devices (that have an expired package date or through charitable donations). Greater care of preparing and cleaning refurbished devices have demonstrated overwhelmingly the safety and effectiveness of reused devices. More recently, cardiac resynchronization therapy and implantable cardioverter-defibrillatorshave also been reused in patients in LMICs. While the globalization of noncommunicable diseases continues, patients with rhythm disorders in LMICs can no longer be left behind. While patients in developed countries only receive new devices to treat rhythm disorders, the practice of reused cardiac implantable electronic deviceswill expand in LMICs, until equal access to device technologies be made available to all.