Aortic Valve Disease
Conditions
Keywords
Minimally Invasive Surgery, Port Access Surgery, Heart, Pacing, Wire, MICS, Cardiac Bypass, Epicardial pacing, pacing catheter, pacing wire, pacing swan, pacing pulmonary catheter, Pulmonary Endovent, Catheter, Aortic Valve Surgery, Edwards Lifesciences
Brief summary
The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that the Endovent kit can be used effectively as a passageway for a pacing wire system.
Detailed description
Many times cardiac surgery requires the use of epicardial pacing in order to wean the patient from bypass. During minimally invasive port access valve surgery, it may not be possible to place the leads on the surface of the heart because of the limited surgical exposure. In this case, transvenous pacing is used. Minimally invasive port access surgery uses specially designed, FDA approved catheters for the procedure. We wish to review the effectiveness of being able to place the wires through the catheters and pace the patient.
Interventions
PROCEDUREMinimally Invasive Aortic Valve
Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.
PROCEDUREMinimally Invasive Aortic Valve Surgery
The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine
DEVICEManipulation in OR surgical technique
Endovent and pacing wire when coming off cardiopulmonary bypass
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 18 years of age patients having aortic valve port access surgery Scheduled for Minimally Invasive Port Access Aortic Valve Study Patient must agree to study participation; understand and sign the written informed consent
Exclusion criteria
* \< 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal | Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean. | Heart to begin pacing upon passing the wire through the catheter to the heart. The catheter would be to be able to pace the heart, with 5 or less milliamps, post heart surgery |
| Number of Participants That Required Pacing Who Were Able to be Paced | Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean. | To be able to pace the heart post aortic valve replacement surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent | Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean. | Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aortic Valve Replacement During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.
Minimally Invasive Aortic Valve: Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.
Minimally Invasive Aortic Valve Surgery: The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine
Manipulation in OR surgical technique: Endovent and pacing wire when coming off cardiopulmonary bypass | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 75 |
Baseline characteristics
| Characteristic | Aortic Valve Replacement |
|---|---|
| Age, Continuous | 74.92 years |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 1 / 23 |
Outcome results
Primary
Number of Participants That Required Pacing Who Were Able to be Paced
To be able to pace the heart post aortic valve replacement surgery
Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve Replacement | Number of Participants That Required Pacing Who Were Able to be Paced | 12 Participants |
Primary
Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal
Heart to begin pacing upon passing the wire through the catheter to the heart. The catheter would be to be able to pace the heart, with 5 or less milliamps, post heart surgery
Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Population: 23 patients were analyzed. Patient # 12 (male, 75 year) and # 19 (male, 61 year) were eliminated from the study after an intraoperative TEE showed additional pathology that changed the operation needed, and thus the operation from a mini AVR to a full sternotomy eliminating the need for the study Endovent pacing lead.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve Replacement | Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal | 23 Participants |
Secondary
Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent
Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs
Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Population: 1 of 6 had hemodynamic disturbances significant enough to act immediately. Subject had PVC's, run of wide complex QRS with concurrent drop of systolic blood pressure to 60's, the pacing wire was pulled out of the ventricle, and blood pressure was restored and arrhythmia disappeared.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacement | Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent | Participant with arrhythmia not requiring intervention | 5 Participants |
| Aortic Valve Replacement | Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent | Participant with arrhythmia requiring intervention | 1 Participants |