Brief Title
Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
Official Title
Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
Brief Summary
During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company). All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the femoral vein. The temporary PMK is associated with a small but significant rate of complications. The PMK is usually removed immediately at the end of the TAVI procedure, only when using the Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications, and thus the PMK is later removed in these cases. PMK Complications seen include: - Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in some cases with Tamponade - Infection - Electrode dislocation causing In-effective pacing (and/or sensing) - Prolonged bed rest - Prolonged hospitalization - Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was associated with the temporary PMK.
Detailed Description
The investigators had experienced not infrequent occurrences of temporary electrode associated tamponade, either acutely after Transcatheter aortic valve implantation (TAVI) completion, or delayed, in association with the electrode removal. The tamponade rate in patients with a temporary pacemaker(PMK) was 14/150 (9.3%). Not all tamponade cases were related to the temporary PMK, 2 occurred in the setting of catastrophic annular rupture and one of the first cases was related to the Left Ventricle stiff wire. The investigators also noted a significant prolongation of bed rest and hospital stay in patients with temporary PMK. Using a flexible permanent pacing electrode which is actively fixed to the Right Ventricle and is placed through the jugular vein will reduce pacing-related complication rates (due to the flexibility of the electrode), time to ambulation (due to the fixation of the electrode), hospital stay and also unnecessary PMK. Cost will also be reduced due to prevention of complications and reduction in Intensive Cardiac Care Unit time. Procedure time might be slightly prolonged since the placement of the standard electrode is more timely, however this prolongation is negligible, and the benefits of the flexible permanent pacing electrode are worth this prolongation
Study Type
Interventional
Primary Outcome
Number of participants with pericardial effusion with or without tamponade
Secondary Outcome
An implantation of permanent pacemaker
Condition
Aortic Stenosis
Intervention
temporary pacemaker insertion
Study Arms / Comparison Groups
Flexible screwed electrode
Description: In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a flexible screwed electrode.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
120
Start Date
June 2016
Completion Date
December 2018
Primary Completion Date
January 2018
Eligibility Criteria
Inclusion Criteria: - All TAVI patients Exclusion Criteria: - Existing contraindication for either femoral or jugular venous access - Refused informed consent - Permanent PMK - Platelets count less than 50 K.
Gender
All
Ages
60 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Amir Orlev, Dr, 972-2-6776564, [email protected]
Administrative Informations
NCT ID
NCT02768064
Organization ID
065015-HMO-CTIL
Responsible Party
Principal Investigator
Study Sponsor
Hadassah Medical Organization
Study Sponsor
Amir Orlev, Dr, Principal Investigator, Hadassah Medical Organization
Verification Date
May 2016