Tan, Min C

AbstractBackgroundReal‐world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited.ObjectiveTo report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database.MethodsWe reviewed all the adverse events reported to the FDA MAUDE database over a 10.7‐year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians.ResultsDuring the study period, a total of 320 procedural‐related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST‐elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra‐procedural death events as a result of cardiac perforation.ConclusionThe two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation.

AbstractBackgroundEvidence on the impact of obesity on catheter ablation for ventricular tachycardia (VT) is scarce.Method and ResultsWe queried the Nationwide Readmissions Database to determine the hospital outcomes and procedural complications of VT ablation among the obese and nonobese populations. Obesity was associated with a more prolonged length of stay (p < .01), higher cost of hospitalization (p < .01), and higher rates of pericardial effusion or hemopericardium (p = .05) and vascular complications (p = .05). There was no significant difference in early mortality, 30‐day readmissions, and other procedural complications.ConclusionVT ablation could be performed relatively safely among patients with obesity.

AbstractBackgroundTransvenous lead extraction (TLE) is increasingly considered in cardiac implantable electronic device management. Heart failure (HF) might be associated with mortality risks after the TLE procedure. This study aims to assess mortality risk in HF patients undergoing TLE.MethodWe searched MEDLINE and Embase databases from inception to June 2022 to identify articles that included patients with and without HF who underwent TLE, which reported mortality in both groups. The pooled effect size was calculated with a random‐effects model and 95% CI to compare post‐TLE mortality between the two groups.ResultsEleven studies were included in the analysis. Each left ventricular ejection fraction (LVEF) increased by 1% was associated with reduced mortality by 2% (HR = 0.98, 95% CI: 0.97–0.99, I2 = 74.9%, p < .01). The presence of HF compared to those without HF was associated with higher mortality rates (OR: 3.04, 95% CI: 2.56–3.61, I2 = 0.0%, p < .531). There was a significant increase in the mortality rates in patients with New York Heart Association (NYHA) function class III (OR: 2.29, 95% CI: 1.29–4.06, I2 = 0.0%, p = .498) and NYHA IV (OR: 8.5, 95% CI: 2.98–24.3, I2 = 0.0%, p = .997).ConclusionsOur study found that post‐TLE mortality decreases by 2% as LVEF increases by 1%, also mortality is higher in patients with NYHA III and IV.

Background: Recognition of the causes of early mortality after atrial fibrillation (AF) catheter ablation is essential for the improvement of patient safety. This study sought to determine the causes of early mortality (≤90 days) after AF ablation. Methods: We performed a retrospective analysis of AF ablation from January 1, 2013, to December 1, 2021 at the Mayo Clinic (Rochester, Phoenix, and Jacksonville). Causes of death were identified through a comprehensive chart review of the electronic health record from within the Mayo Clinic system and outside records when available. Results: A total of 6723 patients were included in the study. The 90-day all-cause mortality rate was 0.22% (n=15). Among all 90-day deaths, majority of the deaths (73.3%) did not have a direct relationship with the procedure. Sudden death was the most common cause of early death (20%), followed by peri-procedural stroke (13%), respiratory failure (13%), atrioesophageal fistula (13%), infection (7%), heart failure (7%), and traumatic brain injury (7%). The 90-day mortality rate directly due to AF ablation procedural complications was 0.06% (n=4). Conclusions: AF ablation procedure has a 90-day mortality of 0.22%, and the most common cause of early mortality was sudden death. The majority (73.3%) of early mortality was not directly associated with a procedural complication, and the mortality rate due to complications associated with the AF ablation procedure was low at 0.06%. Further studies are required to investigate causes and risk factors associated with sudden death in this patient population.

AbstractBackgroundThe impact of chronic kidney disease (CKD) or end‐stage renal disease (ESRD) on patients receiving transvenous lead extraction (TLE) is not well‐established. We performed a systematic review and meta‐analysis to explore the association between CKD and all‐cause mortality in TLE.MethodsWe searched the databases of PubMed and EMBASE from inception to April 2022. Included studies were published TLE studies that compared the risk of mortality in CKD patients compared to control patients. Data from each study were combined using the random‐effects model.ResultsEight studies (5,013 patients) were included. Compared with controls, CKD patients had a significantly higher risk of overall all‐cause mortality (hazard ratio [HR] = 2.14, 95% confidence interval [CI]: 1.65–2.77, I2 = 51.1%, p < .001). The risk of overall all‐cause mortality increased with the severity of CKD for nonspecific CKD (HR = 2.01, 95% CI: 1.49–2.69, I2 = 53.4, p < .001) and ESRD (HR = 2.79, 95% CI: 1.85–4.23, I2 = 0%, p < .001). The risk of all‐cause mortality in CKD is double at follow‐up ≤1 year (HR = 1.99, 95% CI: 1.29–3.09, I2 = 50.9%, p = .002) and higher at follow‐up >1 year (HR = 2.36, 95% CI: 1.63–3.42, I2 = 59.7%, p < .001).ConclusionsOur meta‐analysis demonstrates a significantly increased risk of overall all‐cause mortality in patients with CKD who underwent TLE compared to controls.

Background: Patients with advanced emphysema experience breathlessness due to impaired respiratory mechanics and diaphragm dysfunction. Bronchoscopic lung volume reduction (BLVR) is a minimally invasive bronchoscopic procedure done to reduce hyperinflation and air trapping, promoting atelectasis in the targeted lobe and allowing improved respiratory mechanics. Real-world data on safety and complications outside of clinical trials of BLVR are limited. Methods: We queried the US Food and Drug Administrations (FDA) Manufacturers and User Device Experience database from May 2019 to June 2020 for reports involving BLVR with endobronchial valve (EBV) placement. Events were reviewed for data analysis. Results: We identified 124 cases of complications during BLVR with EBV implantation. The most-reported complication was pneumothorax (110/124, 89%), all of which required chest tube placement. A total of 54 of these cases (54/110, 49%) were complicated by persistent air leak requiring additional interventions. Repeat bronchoscopy was needed to remove the valves in 28 patients, 12 were discharged with a Heimlich valve, and 10 had an additional pleural catheter placed. The other complications of BLVR with EBV placement included respiratory failure (6/124, 5%), pneumonia (4/124, 3%), hemoptysis (2/124, 1.6%), valve migration (1/124, 1%), and pleural effusion (1/124, 1%). A total of 14 deaths were reported during that year. Conclusion: Pneumothorax is the most-reported complication for BLVR with EBV placement, and in 65% of cases, pneumothorax is managed without removing valves. Importantly, 14 deaths were reported during that timeframe. Further studies are needed to estimate the true magnitude of the complications associated with BLVR.