Clinical trial NCT02768064: Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
Official title: Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Number of participants with pericardial effusion with or without tamponade
timeFrame: 1 week
measure: Number of participants with Electrode Dislocation
timeFrame: 1 week
measure: Number of participants with Bleeding complications
timeFrame: 1 week
measure: Number of participants with Infections complications
timeFrame: 1 week
measure: Number of participants with access site complications
timeFrame: 1 week
measure: Number of participants with Pneumothorax
timeFrame: 1 week
measure: Number of participants with pacemaker failure
timeFrame: 1 week
Secondary outcomes:
measure: An implantation of permanent pacemaker
timeFrame: one year
measure: The time (in days) the patient was able to get down from his bed to a chair, after the procedure
timeFrame: week
measure: The time (in days) the patients has stayed in Intensive Cardiac Care Unit
timeFrame: 2 weeks
measure: The Cost of Pacing equipment
timeFrame: 1 week
measure: The TAVI procedure time
timeFrame: 1 day
measure: The TAVI fluoroscopic time
timeFrame: 1 day
measure: The permanent pacemaker activation (if implanted)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Amir Orlev, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.
citation: Barbash IM, Waksman R, Pichard AD. Prevention of right ventricular perforation due to temporary pacemaker lead during transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2013 Apr;6(4):427. doi: 10.1016/j.jcin.2013.01.135. No abstract available.
citation: Rezq A, Basavarajaiah S, Latib A, Takagi K, Hasegawa T, Figini F, Cioni M, Franco A, Montorfano M, Chieffo A, Maisano F, Corvaja N, Alfieri O, Colombo A. Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study. JACC Cardiovasc Interv. 2012 Dec;5(12):1264-72. doi: 10.1016/j.jcin.2012.08.012.