Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial.

Importance: Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated.

Objective: To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR.

Echocardiographic Versus Invasive Aortic Valve Gradients in Different Clinical Scenarios.

Background: The role of echocardiography in deriving transvalvular mean gradients from transaortic velocities in aortic stenosis (AS) and in structural valve degeneration (SVD) is well established. However, reports following surgical aortic valve replacement, post-transcatheter aortic valve replacement (TAVR), and valve-in-valve-TAVR (ViV-TAVR) have cautioned against the use of echocardiography-derived mean gradients to assess normal functioning bioprosthesis due to discrepancy compared with invasive measures in a phenomenon called discordance.

Methods: In a multicenter study, intraprocedural echocardiographic and invasive mean gradients in AS, SVD, post-native TAVR, and post-ViV-TAVR were compared, when obtained concomitantly, and discharge echocardiographic gradients were recorded.

Design and Rationale of the Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System (SAFE-MCS) Study.

Background: High-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) has been associated with varying rates of bleeding due to variable bleeding definitions, incomplete data relative to site-specific bleeding, and inclusion of variable patient populations.

Study Design And Objectives: SAFE-MCS (NCT05077657) is a multicenter, single-arm, open-label study designed to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS). The study aims to enroll 184 evaluable subjects at up to 15 US centers.

Transvalvular Pressure Gradients and All-Cause Mortality Following TAVR: A Multicenter Echocardiographic and Invasive Registry.

Background: Low ejection fraction (EF) and low flow as determined by an echocardiographic stroke volume index (SVi) <35 mL/m are associated with low transvalvular gradients and increased mortality in both severe aortic stenosis (AS) and post-transcatheter aortic valve replacement (TAVR). Absence of an elevated echocardiographic transaortic gradient post-TAVR is considered a marker of procedural success despite the absence of data on its impact on mortality.

Objectives: The authors sought to examine the association of invasive and echocardiographic gradients post-TAVR with all-cause mortality in relation to flow and EF.

Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement.

Background: Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke.

Methods: We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group).

Ejection Fraction Improvement Following Contemporary High-Risk Percutaneous Coronary Intervention: RESTORE EF Study Results.

Background: Despite many reports of clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (HRPCI) with hemodynamic support, little is known about whether this approach improves left ventricular ejection fraction (LVEF). The purpose of the present observational study was to examine, in an ideal patient population with Impella-supported HRPCI, whether there is an impact on left ventricular function at midterm follow-up.

Methods: RESTORE EF is a multicenter, retrospective analysis of a prospectively collected observational data set that aimed to assess 90-day LVEF in patients undergoing Impella-supported nonemergent HRPCI (NCT04648306), who survived with no intervening cardiac procedures prior to the primary endpoint follow-up window (90-day LVEF assessment).

Comparison of Transvalvular Aortic Mean Gradients Obtained by Intraprocedural Echocardiography and Invasive Measurement in Balloon and Self-Expanding Transcatheter Valves.

Background Concerns about discordance between echocardiographic and invasive mean gradients after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEVs) versus self-expanding valves (SEVs) exist. Methods and Results In a multicenter study, direct-invasive and echocardiography-derived transvalvular mean gradients obtained before and after TAVR were compared as well as post-TAVR and discharge echocardiographic mean gradients in BEVs versus SEVs in 808 patients. Pre-TAVR, there was good correlation (=0.

Engineering of a miniaturized, robotic clinical laboratory.

The ability to perform laboratory testing near the patient and with smaller blood volumes would benefit patients and physicians alike. We describe our design of a miniaturized clinical laboratory system with three components: a hardware platform (ie, the miniLab) that performs preanalytical and analytical processing steps using miniaturized sample manipulation and detection modules, an assay-configurable cartridge that provides consumable materials and assay reagents, and a server that communicates bidirectionally with the miniLab to manage assay-specific protocols and analyze, store, and report results (i.e.

A unique complication of the GuideZilla guide extension support catheter and the risk of stent stripping in interventional & endovascular interventions.

Supporting catheters in percutaneous stenting of anatomically difficult coronary lesions are utilized by interventional cardiologists. The GuideZilla guide extension catheter is designed for deep seating in coronary arteries to provide extra guidance support for equipment delivery during difficult coronary interventions or for coaxial alignment in tortuous vessels. There are limited GuideZilla-related complications reported in the literature.

The effect of venous thrombus location and extent on the development of post-thrombotic signs and symptoms.

Objective: This prospective study determined the incidence of signs and symptoms of chronic venous disease and recurrent venous thrombotic events (VTE) in relation to the location and extent of the initial venous thrombus.

Methods: A first episode of acute deep vein thrombosis (DVT) occurred in 120 lower extremities of 105 patients (59 men; mean age, 54 years [range, 23-82 years]). Patients who presented with pain, swelling, or signs and symptoms of pulmonary embolism of <10 days were included.