The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Participants With the Composite Outcome of Moderate or Severe Right Ventricular (RV) Dysfunction (Perioperative Right Heart Failure), Severe Renal Dysfunction Requiring Renal Replacement Therapy, Thrombotic Complications, or Death From Any Cause
Perioperative right ventricular (RV) failure is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scoring as the need for intravenous inotropes for \>14 days post-operatively or a right ventricular assist device (RVAD). RV function will be measured by tricuspid annular plane systolic excursion (TAPSE) values assessed using echocardiography. Additionally, hemodynamic evidence of RV dysfunction will also be collected with: a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67. A thrombotic complication is defined as any thromboembolic event (transient ischemic attack or stroke objectively confirmed with computed tomography) or confirmed pump thrombus.
Time frame: from time of implantation to 30 days post-implantation
Number of Participants With a Need for Blood Product Transfusion Within 48-hours Post-implantation
Time frame: from time of implantation to 48 hours post-implantation
Operative Safety as Indicated by the Number of Participants Who Died Within 30 Days Post-implantation
Time frame: from time of implantation to 30 days post-implantation
Operative Safety as Indicated by Chest Tube Output Within 24 Hours of Implantation
Time frame: from time of implantation to 24 hours post-implantation
Operative Safety as Indicated by Number of Participants Who Underwent Post-operative Re-exploration for Bleeding
Time frame: from time of implantation to 30 days post-implantation
Number of Participants With Allosensitization
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Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.
Time frame: 30 days post-implantation
Number of Participants With Allosensitization
Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.
Time frame: 6 months post-implantation
Number of Participants With Allosensitization
Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.
Time frame: 12 months post-implantation
Number of Readmissions for Heart Failure
Time frame: from time of implantation to 1 year post-implantation
Overall Hemostatic Potential
Time frame: Baseline
Overall Coagulation Potential
Time frame: Baseline
Overall Fibrinolytic Potential
Time frame: Baseline
Overall Hemostatic Potential
Time frame: 48 hours post-implantation
Overall Coagulation Potential
Time frame: 48 hours post-implantation
Overall Fibrinolytic Potential
Time frame: 48 hours post-implantation
Number of Participants With Major Bleeding
Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.
Time frame: 30 days post-implantation
Number of Participants With Major Bleeding
Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.
Time frame: 6 months post-implantation
Number of Participants With Major Bleeding
Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.
Time frame: 12 months post-implantation