Direct Implantation of Transcatheter Valve in Mitral Annular Calcification: A Multicenter Study.

Background: Mitral valve replacement in the setting of severe annular calcification (MAC) is associated with high morbidity and mortality. Direct surgical implantation of a transcatheter heart valve (THV) through a transatrial approach is a strategy to mitigate surgical risk. This study reports the perioperative and 1-year outcomes of mitral valve replacement using a THV in patients with severe circumferential MAC at 3 Canadian centers.

Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial.

Background: XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of VEGF (vascular endothelial growth factor) and more safely and potently induce angiogenesis. The EXACT trial (Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment) assessed the safety and preliminary efficacy of XC001 in patients with no option refractory angina.

Methods: In this single-arm, multicenter, open-label trial, 32 patients with no option refractory angina received a single treatment of XC001 (1×10 viral particles) via transepicardial delivery.

Decision-Making in a Pulmonary Valve Fibroelastoma: The Role of Intraoperative Transesophageal Echocardiography.

• CFEs on the pulmonary valve are rare and management is not covered by guidelines. • Echocardiographic assessment of fibroelastomas on the pulmonary valve is challenging. • TEE is a mainstay to assist in decision-making and postsurgical evaluation.

EXACT Trial: Results of the Phase 1 Dose-Escalation Study.

Background: New therapies are needed for patients with refractory angina. Encoberminogene rezmadenovec (XC001), a novel adenoviral-5 vector coding for all 3 major isoforms of VEGF (vascular endothelial growth factor), demonstrated enhanced local angiogenesis in preclinical models; however, the maximal tolerated dose and safety of direct epicardial administration remain unknown.

Methods: In the phase 1 portion of this multicenter, open-label, single-arm, dose-escalation study, patients with refractory angina received increasing doses of encoberminogene rezmadenovec (1×10, 1×10, 4×10, and 1×10 viral particles) to evaluate its safety, tolerability, and preliminary efficacy.