Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321295
Status:
COMPLETED
Last Update Posted:
2011-04-05
First Post:
2006-05-01
Brief Title:
Biventricular Pacing In Patients With Left Ventricular Dysfunction After Cardiovascular Surgery
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Prospective Evaluation Of Biventricular Pacing In Patients With Left Ventricular Dysfunction After Cardiovascular Surgery
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Congestive heart failure CHF is a medical condition that is due to left ventricular systolic dysfunction LVSD LVSD is a decreased ability of the heart to pump blood forward There are 5 million people in the United States that have CHF and 52828 new cases are diagnosed annually There are 995000 hospital visits and 52828 deaths annually due to CHF Previous studies have shown that people with this condition are at a higher risk for complications immediately after any type of heart surgery than are normal individuals This includes increased dependence on medications and devices to improve the pumping function of the heart and blood pressure Additionally they also have longer lengths of hospital stay and higher rates of death compared to normal individuals
Some patients with LVSD not only have a decreased pumping ability of the heart they also have an inefficient pumping function These patients have been shown to benefit from a device therapy known as biventricular pacing Biventricular pacing involves simultaneously electrically stimulating the two major pumping chambers of the heart known as ventricles using a pacemaker and wires This causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure Studies have confirmed that in these patients implantation of a biventricular pacemaker improves patients symptoms and quality of life as well as decreasing a need for future hospitalizations Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated
Some patients temporarily develop slow heart rates after cardiovascular surgery These slow heart rates can cause a decrease in the blood pumped from the heart and result in low blood pressures Therefore all patients undergoing cardiovascular surgery regardless of left ventricular function receive temporary pacing wires that are placed on one of the ventricles during the surgery Temporary pacing will result in an increase in heart rate and improvement in the amount of blood pumped by the heart and in blood pressure The placement of these wires is precautionary as only a few patients need to be paced for slow heart rates Once patients are felt to no longer require them the wires are easily removed The purpose of this study is to determine whether biventricular pacing immediately after heart surgery in patients with LVSD will improve in-hospital outcomes
Patients that are scheduled for heart surgery and meet the inclusion criteria will be approached for consent to participate in this study Once consented they will be randomized to one of three treatment arms usual care RV pacing single ventricle pacing or biventricular pacing Randomization is a process similar to picking numbers out of a hat The patients will then undergo surgery as scheduled During the surgery the patients will receive the temporary pacing wires on both ventricles instead of one Immediately after surgery the patients will receive either usual care RV pacing or biventricular pacing depending upon the treatment arm that they were randomized to The pacing wires will be removed as soon as the patients become stable as per routine The clinical operative and in-hospital characteristics of these patients will be recorded on specialized forms The characteristics of those that received biventricular pacing will be compared to those that had RV or no pacing to see whether there was any benefit to this mode of therapy
Some patients with LVSD not only have a decreased pumping ability of the heart they also have an inefficient pumping function These patients have been shown to benefit from a device therapy known as biventricular pacing Biventricular pacing involves simultaneously electrically stimulating the two major pumping chambers of the heart known as ventricles using a pacemaker and wires This causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure Studies have confirmed that in these patients implantation of a biventricular pacemaker improves patients symptoms and quality of life as well as decreasing a need for future hospitalizations Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated
Some patients temporarily develop slow heart rates after cardiovascular surgery These slow heart rates can cause a decrease in the blood pumped from the heart and result in low blood pressures Therefore all patients undergoing cardiovascular surgery regardless of left ventricular function receive temporary pacing wires that are placed on one of the ventricles during the surgery Temporary pacing will result in an increase in heart rate and improvement in the amount of blood pumped by the heart and in blood pressure The placement of these wires is precautionary as only a few patients need to be paced for slow heart rates Once patients are felt to no longer require them the wires are easily removed The purpose of this study is to determine whether biventricular pacing immediately after heart surgery in patients with LVSD will improve in-hospital outcomes
Patients that are scheduled for heart surgery and meet the inclusion criteria will be approached for consent to participate in this study Once consented they will be randomized to one of three treatment arms usual care RV pacing single ventricle pacing or biventricular pacing Randomization is a process similar to picking numbers out of a hat The patients will then undergo surgery as scheduled During the surgery the patients will receive the temporary pacing wires on both ventricles instead of one Immediately after surgery the patients will receive either usual care RV pacing or biventricular pacing depending upon the treatment arm that they were randomized to The pacing wires will be removed as soon as the patients become stable as per routine The clinical operative and in-hospital characteristics of these patients will be recorded on specialized forms The characteristics of those that received biventricular pacing will be compared to those that had RV or no pacing to see whether there was any benefit to this mode of therapy
Detailed Description:
1 Basis for the studystudy rationale Patients with congestive heart failure have high rates of mortality and morbidity 1 There are 5 million people in the United States that have congestive heart failure CHF and 52828 new cases are diagnosed annually There are 995000 hospital visits with 52828 deaths annually due to this condition Although there have been numerous medical advances in drug therapy there was a 164 increase in the number of hospital admissions for CHF since 1979 1 2
Biventricular BiV pacing has been shown to have acute and chronic benefits in a subset of patients with CHF 3-6 Those that have been shown to benefit from this mode of therapy have left ventricular systolic dysfunction with a widened QRS duration on the electrocardiogram Acute hemodynamic studies comparing patients at baseline with either right ventricular RV or BiV pacing show significant improvements in the systolic blood pressure and cardiac output in patients with BiV pacing compared to either RV pacing or baseline measurements 3 4 Furthermore BiV pacing was associated with decrease in the pulmonary capillary wedge pressure PCWP and diastolic mitral regurgitation These acute hemodynamic benefits are sustained and manifest as improvements in clinical symptoms The Multisite Stimulation in Cardiomyopathies MUSTIC study showed that BiV pacing was associated with a 23 increase in the distance walked in six minutes P0001 a 32 increase in the quality-of-life score P0001 an 8 increase in the peak oxygen uptake P003 and a 66 decrease in the need for hospitalization P005 compared to no pacing 5 Patients also preferred BiV pacing compared to no pacing P0001 The Multicenter InSync Randomized Clinical Evaluation MIRACLE study not only confirmed many of the findings of the MUSTIC trial but also showed improvement in the left ventricular ejection fraction LVEF with BiV pacing 46 vs -02 P0001 compared to non-paced controls 6 Such data has led to the classification of BiV pacing in patients with dilated cardiomyopathy as a class IIa recommendation by ACCAHANASPE guidelines 7
Coronary artery bypass grafting CABG in patients with left ventricular dysfunction carries a high mortality 8 Furthermore patients with a low LVEF have a greater need for intraaortic balloon pump P00001 and inotropic support P0001 with a longer length of hospital stay P0002 compared with those with normal LVEF 9 10
Conduction system abnormalities following CABG are common 11 12 The majority of these abnormalities are transient and are often managed using temporary epicardial pacing Hence all patients that undergo CABG receive epicardial leads as a precautionary measure These leads are placed on the right or left ventricle and the right atrium When patients are felt to no longer require these they are removed easily The role of BiV pacing in this setting is unknown Whether patients that have left ventricular dysfunction would have improved post-operative mortality less need for intraaortic balloon pump and inotropic support and shorter length of hospital stay is unknown
2 Objectives Our hypothesis is that BiV pacing immediately following CABG will improve in-hospital outcomes in patients with left ventricular systolic dysfunction
Endpoints
Primary -Length of ICU stay
Secondary -In-hospital mortality
Length of hospital stay
Duration of inotropic support
Duration of intraaortic ballon pump support
Duration of mechanical ventillation
Change in stroke volume with biventricular pacing
Change in ventricular synchrony with biventricular pacing
3 Methodology All patients that are scheduled for CABG or valve surgery and meet the inclusion criteria will be approached for consent pre-operatively Once consent is obtained the patient will be randomized into one of three treatment arms usual care RV pacing or BiV pacing The patients will then undergo surgery as per routine During cardiovascular surgery patients routinely receive epicardial pacing leads that are placed on the right or left ventricle and the right atrium For the purposes of this study epicardial pacing leads will be placed on both the right and left ventricles as well as the right atrium
After surgery is completed the patients will receive either usual care RV pacing or BiV pacing depending upon their treatment arms Intraoperative transesophageal echocardiography TEE is routinely performed during cardiac surgery If TEE is being used in the subject images will be recorded with biventricular pacing right ventricular pacing and no pacing in the first 30 patients studied to quantify changes in vetricular synchrony with biventricular pacing Once the patient arrives in the SICU hemodynmic monitoring will be performed as usual All patients return from the operating room with a pulmonary artery catheter In the first 50 patients the stroke volume will be obtained by thermodilution method using the pulmonary artery catheter in their assigned treatment arm as well as following 2 minutes of right ventricular pacing and again following 2 minutes of biventricular pacing Pacing will be continued in the assigned treatment arm until all inotropic and intraortic ballon pump support has been weaned off Crossover in treatment arms is discouraged but will be at the discretion of the treating physicians The epicardial pacing leads will be removed as per routine
4 InclusionExclusion Criteria
Inclusion Criteria
1 Age 18 years
2 Planned CABG andor valve surgery
3 LVEF 30
4 Able to give written informed consent
Exclusion Criteria
1 Enrollment in other research protocols
2 Inability to give written informed consent
3 Pregnancy
5 Methods of data acquisition and analysis Clinical operative and in-hospital information for each subject will be recorded on standardized case report forms see attached at the time of hospitalization or soon after discharge The characteristics of those that received BiV pacing will be compared to those that received either no pacing or RV pacing The data will be recorded in a manner such that there are no patient identifiers The information will then be transferred to a computer database The case report forms will be kept under lock and key on the third floor of the WBH Heart Center The computer data base will be password protected Only the investigators will have access to the case report forms or computer database
6 References
1 American Heart Association Heart Disease and Stroke Statistics - 2004Update Dallas Texas American Heart Association 2003
2 Braunwald E Bristow MR Congestive heart failure fifty years of progress Circulation 2000 102 suppl 4IV14-IV23
3 Blanc JJ Etienne Y Gilard M et al Evaluation of different ventricular pacing sites in patients with severe heart failure Results of an acute hemodynamic study Circulation 1997963273-3277
4 Leclercq C Cazeau S Breton HL et al Acute hemodynamic effects of biventricular DDD pacing in patients with end-stage heart failure J Am Coll Cardiol 1998321825-1831
5 Cazeau S Leclercq C Lavergne T et al Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay N Engl J Med 2001334873-80
6 Abraham WT Fisher WG Smith AL et al Cardiac resynchronization in chronic heart failure N Engl J Med 20023461845-53
7 Gregoratos G Abrams J Epstein AE et al ACCAHANASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices summary article a report of the Am College of CardiologyAm Heart Association Task Force on Practice Guidelines ACCAHANASPE Committee to Update the 1998 Pacemaker Guidelines Circulation 20021062145-2161
8 Alderman EL Fisher LD Litwin P et al Results of coronary artery surgery in patients with poor left ventricular function CASS Circulation 198368785-95
9 Trachiotis GD Weintraub WS Johnston TS et al Coronary artery bypass grafting in patients with advanced left ventricular dysfunction Ann Thorac Surg 1998661632-1639
10 Antunes PE Ferrao de Oliveira JM and Antunes MJ Coronary surgery with non-cardioplegic methods in patients with advanced left ventricular dysfunction immediate and long term results Heart 200389427-431
11 Pires LA Wagshal AB Lancey R et al Arrhythmias and conduction disturbances after coronary artery bypass graft surgery epidemiology management and prognosis Am Heart J 1995129799-808
12 Mustonen P Hippelainen M Vanninen E et al Significance of coronary artery bypass grafting-associated conduction defects Am J Cardiol 199881558-563
Biventricular BiV pacing has been shown to have acute and chronic benefits in a subset of patients with CHF 3-6 Those that have been shown to benefit from this mode of therapy have left ventricular systolic dysfunction with a widened QRS duration on the electrocardiogram Acute hemodynamic studies comparing patients at baseline with either right ventricular RV or BiV pacing show significant improvements in the systolic blood pressure and cardiac output in patients with BiV pacing compared to either RV pacing or baseline measurements 3 4 Furthermore BiV pacing was associated with decrease in the pulmonary capillary wedge pressure PCWP and diastolic mitral regurgitation These acute hemodynamic benefits are sustained and manifest as improvements in clinical symptoms The Multisite Stimulation in Cardiomyopathies MUSTIC study showed that BiV pacing was associated with a 23 increase in the distance walked in six minutes P0001 a 32 increase in the quality-of-life score P0001 an 8 increase in the peak oxygen uptake P003 and a 66 decrease in the need for hospitalization P005 compared to no pacing 5 Patients also preferred BiV pacing compared to no pacing P0001 The Multicenter InSync Randomized Clinical Evaluation MIRACLE study not only confirmed many of the findings of the MUSTIC trial but also showed improvement in the left ventricular ejection fraction LVEF with BiV pacing 46 vs -02 P0001 compared to non-paced controls 6 Such data has led to the classification of BiV pacing in patients with dilated cardiomyopathy as a class IIa recommendation by ACCAHANASPE guidelines 7
Coronary artery bypass grafting CABG in patients with left ventricular dysfunction carries a high mortality 8 Furthermore patients with a low LVEF have a greater need for intraaortic balloon pump P00001 and inotropic support P0001 with a longer length of hospital stay P0002 compared with those with normal LVEF 9 10
Conduction system abnormalities following CABG are common 11 12 The majority of these abnormalities are transient and are often managed using temporary epicardial pacing Hence all patients that undergo CABG receive epicardial leads as a precautionary measure These leads are placed on the right or left ventricle and the right atrium When patients are felt to no longer require these they are removed easily The role of BiV pacing in this setting is unknown Whether patients that have left ventricular dysfunction would have improved post-operative mortality less need for intraaortic balloon pump and inotropic support and shorter length of hospital stay is unknown
2 Objectives Our hypothesis is that BiV pacing immediately following CABG will improve in-hospital outcomes in patients with left ventricular systolic dysfunction
Endpoints
Primary -Length of ICU stay
Secondary -In-hospital mortality
Length of hospital stay
Duration of inotropic support
Duration of intraaortic ballon pump support
Duration of mechanical ventillation
Change in stroke volume with biventricular pacing
Change in ventricular synchrony with biventricular pacing
3 Methodology All patients that are scheduled for CABG or valve surgery and meet the inclusion criteria will be approached for consent pre-operatively Once consent is obtained the patient will be randomized into one of three treatment arms usual care RV pacing or BiV pacing The patients will then undergo surgery as per routine During cardiovascular surgery patients routinely receive epicardial pacing leads that are placed on the right or left ventricle and the right atrium For the purposes of this study epicardial pacing leads will be placed on both the right and left ventricles as well as the right atrium
After surgery is completed the patients will receive either usual care RV pacing or BiV pacing depending upon their treatment arms Intraoperative transesophageal echocardiography TEE is routinely performed during cardiac surgery If TEE is being used in the subject images will be recorded with biventricular pacing right ventricular pacing and no pacing in the first 30 patients studied to quantify changes in vetricular synchrony with biventricular pacing Once the patient arrives in the SICU hemodynmic monitoring will be performed as usual All patients return from the operating room with a pulmonary artery catheter In the first 50 patients the stroke volume will be obtained by thermodilution method using the pulmonary artery catheter in their assigned treatment arm as well as following 2 minutes of right ventricular pacing and again following 2 minutes of biventricular pacing Pacing will be continued in the assigned treatment arm until all inotropic and intraortic ballon pump support has been weaned off Crossover in treatment arms is discouraged but will be at the discretion of the treating physicians The epicardial pacing leads will be removed as per routine
4 InclusionExclusion Criteria
Inclusion Criteria
1 Age 18 years
2 Planned CABG andor valve surgery
3 LVEF 30
4 Able to give written informed consent
Exclusion Criteria
1 Enrollment in other research protocols
2 Inability to give written informed consent
3 Pregnancy
5 Methods of data acquisition and analysis Clinical operative and in-hospital information for each subject will be recorded on standardized case report forms see attached at the time of hospitalization or soon after discharge The characteristics of those that received BiV pacing will be compared to those that received either no pacing or RV pacing The data will be recorded in a manner such that there are no patient identifiers The information will then be transferred to a computer database The case report forms will be kept under lock and key on the third floor of the WBH Heart Center The computer data base will be password protected Only the investigators will have access to the case report forms or computer database
6 References
1 American Heart Association Heart Disease and Stroke Statistics - 2004Update Dallas Texas American Heart Association 2003
2 Braunwald E Bristow MR Congestive heart failure fifty years of progress Circulation 2000 102 suppl 4IV14-IV23
3 Blanc JJ Etienne Y Gilard M et al Evaluation of different ventricular pacing sites in patients with severe heart failure Results of an acute hemodynamic study Circulation 1997963273-3277
4 Leclercq C Cazeau S Breton HL et al Acute hemodynamic effects of biventricular DDD pacing in patients with end-stage heart failure J Am Coll Cardiol 1998321825-1831
5 Cazeau S Leclercq C Lavergne T et al Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay N Engl J Med 2001334873-80
6 Abraham WT Fisher WG Smith AL et al Cardiac resynchronization in chronic heart failure N Engl J Med 20023461845-53
7 Gregoratos G Abrams J Epstein AE et al ACCAHANASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices summary article a report of the Am College of CardiologyAm Heart Association Task Force on Practice Guidelines ACCAHANASPE Committee to Update the 1998 Pacemaker Guidelines Circulation 20021062145-2161
8 Alderman EL Fisher LD Litwin P et al Results of coronary artery surgery in patients with poor left ventricular function CASS Circulation 198368785-95
9 Trachiotis GD Weintraub WS Johnston TS et al Coronary artery bypass grafting in patients with advanced left ventricular dysfunction Ann Thorac Surg 1998661632-1639
10 Antunes PE Ferrao de Oliveira JM and Antunes MJ Coronary surgery with non-cardioplegic methods in patients with advanced left ventricular dysfunction immediate and long term results Heart 200389427-431
11 Pires LA Wagshal AB Lancey R et al Arrhythmias and conduction disturbances after coronary artery bypass graft surgery epidemiology management and prognosis Am Heart J 1995129799-808
12 Mustonen P Hippelainen M Vanninen E et al Significance of coronary artery bypass grafting-associated conduction defects Am J Cardiol 199881558-563
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None