Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study.

BACKGROUND: Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation. OBJECTIVES: The Optimize PRO study evaluates valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves. METHODS: Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT. RESULTS: A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI. CONCLUSIONS: The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048).

Correction to: A Novel Bridging Strategy for Patients Undergoing Emergent Non-Cardiac Surgery with a Recent Coronary Stent.

In the original publication, the abstract text, informed consent and disclosure text have been published incorrectly.

A Novel Bridging Strategy for Patients Undergoing Emergent Non-Cardiac Surgery with a Recent Coronary Stent.

INTRODUCTION: Not infrequently, patients undergoing dual antiplatelet therapy for a recent cardiac stent develop a need for a non-cardiac surgery. Most of these surgeries can be delayed while the antiplatelet treatment is stopped and normal platelet function returns in order to avoid potential surgical complications and excessive bleeding. However, there are a number of patients who require urgent surgery where the procedure cannot be postponed. To date, no agents have been proven to bridge the patient off dual-antiplatelet therapy. METHODS: A 46-year-old man was admitted to the hospital with an acute anterior wall myocardial infarction. He was urgently taken to the catheterization lab where he was found to have a totally occluded proximal left anterior descending coronary artery (LAD). He was successfully stented with a drug-eluting stent of the LAD, but subsequently developed a sarcoma 2 months later that required urgent surgery. The novel direct-acting, reversible P2Y12 receptor inhibitor cangrelor was used to bridge this patient followed by ongoing antiplatelet treatment, allowing surgery for the removal of a soft tissue sarcoma. RESULTS: Cangrelor was successfully used to bridge a patient with a recent stent placement and current antiplatelet treatment undergoing the removal of a soft tissue sarcoma. CONCLUSION: This case report demonstrates the use of a novel, now currently available, short-acting antiplatelet agent that can be used for bridging patients undergoing non-cardiac surgery who had a recent myocardial infarction and stent placement.