Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients (PAMIT)

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.

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

In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a flexible screwed electrode.

In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a stiff standard temporary electrode

Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).

Pericardial effusion estimated by echocardiography, will be done during the hospitalization. It will be described as minimal/mild/moderate/large

Electrode Dislocation (sensing / pacing problems, requiring lead re-positioning). The dislocation will be diagnosed by chest X ray or by sensing / pacing parameters.

Bleeding complications, described as local hematoma within the area of the electrode insertion, during the procedure or the hospitalization.

Infections complications, described as fever above 38.0 celsius degree or positive blood culture during the hospitalization after the procedure.

An implantation of permanent pacemaker (of any company, of any reason) within a year after TAVI in any hospital. The data will be collect from the hospital medical record system, and the patient report

The number of days from the TAVI procedure to the first time the patient was able to get down from his bad and sit on a chair. The data will be collected from the nurse description in the medical record.

The number of days the patient was hospitalized in Intensive Cardiac Care Unit. The number will be calculated from the end of the TAVI procedure, till the patient went home or moved into the Cardiology department.

If a pacemaker was implanted to the patient, the data will be collected from the interrogation of the pacemaker.

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.

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.

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.

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.