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.

Study Overview

• Status: Unknown
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: temporary pacemaker insertion

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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flexible screwed electrode; In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a flexible screwed electrode.	Device: temporary pacemaker insertion; Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).
Active Comparator: Stiff standard electrode; In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a stiff standard temporary electrode	Device: temporary pacemaker insertion; Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with pericardial effusion with or without tamponade	Pericardial effusion estimated by echocardiography, will be done during the hospitalization. It will be described as minimal/mild/moderate/large	1 week
Number of participants with Electrode Dislocation	Electrode Dislocation (sensing / pacing problems, requiring lead re-positioning). The dislocation will be diagnosed by chest X ray or by sensing / pacing parameters.	1 week
Number of participants with Bleeding complications	Bleeding complications, described as local hematoma within the area of the electrode insertion, during the procedure or the hospitalization.	1 week
Number of participants with Infections complications	Infections complications, described as fever above 38.0 celsius degree or positive blood culture during the hospitalization after the procedure.	1 week
Number of participants with access site complications	Access site complications describe as perforation of near organs (jugular artery)	1 week
Number of participants with Pneumothorax	Pneumothorax diagnosed by clinical examination and CXR within 3 days after the procedure.	1 week
Number of participants with pacemaker failure	Rates of Pacing or sensing failure during the procedure, or the days after,	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
An implantation of permanent pacemaker	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	one year
The time (in days) the patient was able to get down from his bed to a chair, after the procedure	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.	week
The time (in days) the patients has stayed in Intensive Cardiac Care Unit	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.	2 weeks
The Cost of Pacing equipment	Will be calculate by the sum of the electrode cost and the vascular shith cost	1 week
The TAVI procedure time	Will be taken from the technician report of starting and ending of the TAVI procedure	1 day
The TAVI fluoroscopic time	Will be taken from technician report of Fluoroscopic time	1 day
The permanent pacemaker activation (if implanted)	If a pacemaker was implanted to the patient, the data will be collected from the interrogation of the pacemaker.	1 year

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Amir Orlev, Dr, Hadassah Medical Organization

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 065015-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No