Two recently studies published in Circulation and Revista Española de Cardiología have found that a high number of Corevalve implant patients require a permanent pacemaker shortly after the procedure.
A UK study recently published in Circulation, “Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation,” has found that almost one third of patients undergoing a TAVI procedure for severe aortic stenosis required a permanent pacemaker within 30 days.
Researchers led by David J Hildick-Smith at the Sussex Cardiac Centre in Brighton, East Sussex, UK, examined data from 270 patients at 10 centres who were implanted with the CoreValve system from 2007 to 2009.
Twenty five patients (8%) had pre-existing permanent pacemakers and two patients had incomplete data. Of the remaining 243 patients, 50.6% were male and mean age was 81.3±6.7. Eighty-one patients (33.3%) required a permanent pacemaker within 30 days and median time to insertion was four days (2−7.75 days).
Multivariable analysis revealed the strongest independent predictors for a permanent pacemaker were periprocedural atrioventricular block and balloon predilatation. Additional factors were the use of the larger (29mm) CoreValve prosthesis, increased interventricular septum diameter and prolonged QRS duration.
Similar findings were revealed in a study published in Revista Española de Cardiología in December 2010, “Changes in atrioventricular conduction and predictors of pacemaker need after percutaneous implantation of the CoreValve aortic valve prosthesis.”
Antonio J Muñoz-García from the Hospital Clínico Universitario Virgen de la Victoria in Malaga, Spain, led the study in which a high percentage of patients required a permanent pacemaker for advanced atrioventricular block after the implantation of the CoreValve aortic valve prosthesis.
Sixty five patients (mean age 79±7.8 years) with symptomatic severe aortic stenosis received the prosthesis between April 2008 and October 2009. Four patients were excluded: three had a pacemaker and the fourth died during the procedure. Implantation was successful in 98.4% of patients, after which 47.5% had a left bundle branch block and 21 patients (34.4%) required a permanent pacemaker.
“The need for a pacemaker was associated with a greater depth of prosthesis implantation in the left ventricular outflow tract: 13±2.5 mm vs. 8.8±2.8 mm (p< 0.001). Moreover, depth was the only predictor: odds ratio 1.9, 95% confidence interval 1.19−3.05 (p< 0.007). A cutpoint of 11.1mm for the prosthesis depth in the left ventricular outflow tract had a sensitivity of 81% and a specificity of 84.6% for predicting the need for a pacemaker,” investigators found.