Cath Lab Recap: Pacing After Lotus TAVR; CMS on Leadless Pacemakers

Almost one-third of patients who received the Lotus Valve for transcatheter aortic valve replacement required implantation of a permanent pacemaker, a small study reported in Catheterization and Cardiovascular Interventions. Independent predictors of need for pacing were pre-existing right bundle branch block and valve placement below the non-coronary cusp.

CMS announced plans this week to cover leadless pacemakers only in the context of FDA-approved studies. Medtronic's Micra was granted FDA approval in April, while St. Jude Medical's Nanostim could gain regulatory clearance later this year.

The FDA cleared the Claria MRI Quad CRT-D SureScan for patients with heart failure, manufacturer Medtronic announced. The cardiac resynchronization therapy device is compatible for scanning in both 1.5 and 3 Tesla MRI machines. (Medgadget)

A novel thick gelatin-based hydrogel can put a stopper on major bleeding, according to a report in Science Translational Medicine. The study was performed in mice and pigs and showed no signs of fragmentation or embolization at 24 days.

Femoral artery occlusion arising from use of the Angio-Seal vascular closure device could be treated with directional atherectomy followed by balloon angioplasty, according to a small case series in Vascular and Endovascular Surgery. With that approach, there were no complications and "good" outcomes during more than 20 months' follow-up.

An adaptive trial design featuring an "enriched" population could improve a study's statistical power, according to a look back at data collecting from the Interventional Management of Stroke III trial. Although adaptive subgroup selection did not raise the power overall from the original fixed trial design (47% versus 45%), the power was raised to 82% when patients were stratified by stroke onset-to-randomization time. (Stroke)

Safety and outcomes were patients getting ablation via percutaneous epicardial access whether sedated or put under general anesthesia, according to a study in Europace. The authors concluded that "for patients in whom anaesthesia may pose increased risk, it is reasonable to obtain epicardial access under sedation."

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