Pulmonary vein narrowing after pulsed field versus thermal ablation.

Aims: When it occurs, pulmonary vein (PV) stenosis after atrial fibrillation (AF) ablation is associated with significant morbidity. Even mild-to-moderate PV narrowing may have long-term implications. Unlike thermal ablation energies, such as radiofrequency (RF) or cryothermy, pulsed field ablation (PFA) is a non-thermal modality associated with less fibrotic proliferation.

Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation.

Background: Catheter-based pulmonary vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation, which delivers microsecond high-voltage electrical fields, may limit damage to tissues outside the myocardium. The efficacy and safety of pulsed field ablation as compared with conventional thermal ablation are not known.

Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia.

Background: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation.

Methods: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options.

Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial.

Objectives: The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis.

Background: Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated.

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

Background: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk.

Methods: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement.

Peripheral artery disease is an independent predictor of mortality after implantable cardioverter-defibrillator implantation in patients with severe left ventricular dysfunction.

The impact of peripheral artery disease (PAD) on survival in implantable cardioverter defibrillator (ICD) patients is poorly understood. Thus, we assessed the risk of PAD in our adult ICD patients with left ventricular dysfunction (ejection fraction [EF] ≤35%). Survival was estimated with Kaplan-Meier method and compared by the log-rank test; a Cox proportional hazards model assessed the effects of clinical variables on survival.

Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads.

Background: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance.

Objective: To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers.

Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis.

Background: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) can be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent interventions. A bioabsorbable, steroid-releasing sinus implant has been studied in 2 prospective, randomized clinical trials for its ability to preserve sinus patency and reduce medical and surgical interventions after ESS in patients with CRS. The objective of this study was to perform a meta-analysis of the efficacy results from the 2 trials.

Early detection of an underperforming implantable cardiovascular device using an automated safety surveillance tool.

Background: Postmarket medical device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable cardiac device was underperforming.

Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants.

Objective: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) may be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent intervention. To address this issue, the authors investigated the safety and effectiveness of controlled delivery of mometasone furoate to the sinus mucosa via bioabsorbable implants deployed at the time of ESS.

Study Design: Prospective, multicenter, randomized, controlled, double-blind trial using an intrapatient control design.

Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent.

Background: Inflammation/polyp recurrence, adhesions, and middle turbinate lateralization are causes of suboptimal outcomes following sinus surgery and lead to increased rates of revision. A bioabsorbable, drug-eluting stent was evaluated for its ability to preserve sinus patency by providing controlled steroid delivery to the sinus mucosa. The study objective was to assess safety and efficacy of a steroid-eluting sinus stent when used following functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis (CRS).

Longevity of Sprint Fidelis implantable cardioverter-defibrillator leads and risk factors for failure: implications for patient management.

Background: Sprint Fidelis (Fidelis) implantable cardioverter-defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure.

Hierarchical statistical modelling of influenza epidemic dynamics in space and time.

An infectious disease typically spreads via contact between infected and susceptible individuals. Since the small-scale movements and contacts between people are generally not recorded, available data regarding infectious disease are often aggregations in space and time, yielding small-area counts of the number infected during successive, regular time intervals. In this paper, we develop a spatially descriptive, temporally dynamic hierarchical model to be fitted to such data.