Comparing the Effectiveness of a Mitral Valve Repair Proc... | NCT00806988

NCT00806988

ID	Type	Description	Link
U01HL088942	U.S. NIH Grant/Contract		View source
594	Other Identifier	Ct Surgery Network Research Group

Status Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
Canadian Institutes of Health Research (CIHR)	OTHER_GOV
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Description Module

Detailed Description

CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. CABG is one treatment option for people with CAD. During a CABG procedure, a healthy artery or vein from another part of the body is connected to the blocked coronary artery. Blood flow is then routed around the blockage to the heart.

After a heart attack, some people may have a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR) and is associated with poor health outcomes, including worsening heart failure. In people with severe mitral valve leakage, the CABG procedure and a mitral valve repair procedure are routinely performed together; however, in people with only moderate valve leakage, there is no consensus in the medical community as to whether the mitral valve repair procedure is beneficial at the time of CABG. The purpose of this study is to determine whether people with moderate mitral valve regurgitation should undergo a mitral valve repair procedure in addition to CABG or undergo CABG alone.

This study will enroll people with CAD who require a CABG procedure and have moderate mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either CABG surgery and the mitral valve repair procedure or only CABG surgery. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitral Valve Repair	Active Comparator	Participants will undergo CABG and a mitral valve repair procedure.	Procedure: Mitral Valve Repair Procedure: CABG
CABG	Active Comparator	Participants will undergo CABG.	Procedure: CABG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mitral Valve Repair	Procedure	Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following: All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed. The heart will be arrested with cardioplegia. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.

Measure	Description	Time Frame
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)		Measured at Month 12

Measure	Description	Time Frame
Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention		Measured at Month 24

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO between 0.2 cmsq to 0.39 cmsq. If ERO < 0.2, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
CAD that is amenable to CABG and a clinical indication for revascularization
Age ≥ 18 years

Exclusion Criteria:

Any evidence of structural (chordal or leaflet) mitral valve disease
Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
Planned concomitant intra-operative procedures (with the exception of closure of patent foramen ovale [PFO] or atrial septal defect [ASD]or Maze procedure or left atrial appendage excision)
Prior surgical or percutaneous mitral valve repair
Contraindication to cardiopulmonary bypass (CPB)
Clinical signs of cardiogenic shock at the time of surgery
Treatment with chronic intravenous inotropic therapy at the time of surgery
Severe, irreversible pulmonary hypertension in the judgment of the investigator
ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery
Congenital heart disease (except PFO or ASD)
Evidence of cirrhosis or liver synthetic failure
Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of the investigator
Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in the study
Any concurrent disease with a life expectancy of less than 2 years
Pregnancy at the time of randomization

Name	Affiliation	Role
Timothy Gardner, MD	Christiana Care Health Services	Study Chair
Patrick O'Gara, MD	Brigham and Women's Hospital	Study Chair
Annetine Gelijns, Ph.D.	Icahn School of Medicine at Mount Sinai	Principal Investigator
Alan Moskowitz, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California		Los Angeles	California	90033	United States
Emory University

PubMed Identifier	Type	Citation	Retractions
25405390	Result	Smith PK, Puskas JD, Ascheim DD, Voisine P, Gelijns AC, Moskowitz AJ, Hung JW, Parides MK, Ailawadi G, Perrault LP, Acker MA, Argenziano M, Thourani V, Gammie JS, Miller MA, Page P, Overbey JR, Bagiella E, Dagenais F, Blackstone EH, Kron IL, Goldstein DJ, Rose EA, Moquete EG, Jeffries N, Gardner TJ, O'Gara PT, Alexander JH, Michler RE; Cardiothoracic Surgical Trials Network Investigators. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med. 2014 Dec 4;371(23):2178-88. doi: 10.1056/NEJMoa1410490. Epub 2014 Nov 18.
33573741

Label	URL
Click here for the Cardiothoracic Surgical Trials Network Web site.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mitral Valve Repair	Participants will undergo CABG and a mitral valve repair procedure. Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following: All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed. The heart will be arrested with cardioplegia. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings. CABG: CABG will be performed using

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Mitral Valve Repair	Participants will undergo CABG and a mitral valve repair procedure. Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following: All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed. The heart will be arrested with cardioplegia. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings. CABG: CABG will be performed using
BG001	CABG	Participants will undergo CABG. CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)

Posted

Mean

Standard Deviation

ml per square meter

Measured at Month 12

ID	Title	Description
OG000	Mitral Valve Repair	Participants will undergo CABG and a mitral valve repair procedure. Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following: All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed. The heart will be arrested with cardioplegia. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings. CABG: CABG will be performed using
OG001	CABG	Participants will undergo CABG. CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.

Units	Counts
Participants	OG000150 OG001151

Title

Denominators

Categories

Title	Measurements
	OG00049.6± 31.5 OG00146.1± 22.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.	Wilcoxon (Mann-Whitney)		0.61														Other	An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.

Secondary

Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention

Posted

Count of Participants

Participants

Measured at Month 24

ID	Title	Description
OG000	Mitral Valve Repair	Participants will undergo CABG and a mitral valve repair procedure. Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following: All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed. The heart will be arrested with cardioplegia. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings. CABG: CABG will be performed using
OG001	CABG	Participants will undergo CABG. CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mitral Valve Repair	Participants will undergo CABG and a mitral valve repair procedure. Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following: All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed. The heart will be arrested with cardioplegia. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings. CABG: CABG will be performed using	15	150	88	150	44	150
EG001	CABG	Participants will undergo CABG. CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.	16	151	79	151	37	151

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bleeding	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0016 events5 affected151 at risk
Arrhythmias - Sustained ventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG0004 events4 affected150 at risk EG0015 events5 affected151 at risk
Arrhythmias - Sustained supraventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG00024 events22 affected150 at risk EG00111 events11 affected151 at risk
Pericardial Fluid Collection	Cardiac disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected151 at risk
Hepatic Dysfunction	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected151 at risk
Major Infection - Localized	Infections and infestations	Systematic Assessment	EG00025 events18 affected150 at risk EG00122 events15 affected151 at risk
Major Infection - Endocarditis	Cardiac disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected151 at risk
Major Infection - Sepsis	Infections and infestations	Systematic Assessment	EG0009 events8 affected150 at risk EG0017 events6 affected151 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected151 at risk
Myocardial infarction - Peri-CABG MI	Cardiac disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Myocardial infarction - Peri-Percutaneous Intervention MI	Cardiac disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Neurological Dysfunction - TIA	Nervous system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Neurological Dysfunction - CVA-Ischemic	Nervous system disorders	Systematic Assessment	EG0006 events6 affected150 at risk EG0012 events2 affected151 at risk
Neurological Dysfunction - CVA-Hemorrhagic	Nervous system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Neurological Dysfunction - Toxic Metabolic Encephalopathy	Nervous system disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0010 events0 affected151 at risk
Neurological Dysfunction - Other	Nervous system disorders	Systematic Assessment	EG0004 events4 affected150 at risk EG0011 events1 affected151 at risk
Renal dysfunction (no dialysis)	Renal and urinary disorders	Systematic Assessment	EG0007 events7 affected150 at risk EG0012 events2 affected151 at risk
Renal failure (dialysis)	Renal and urinary disorders	Systematic Assessment	EG0006 events5 affected150 at risk EG0017 events6 affected151 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00010 events9 affected150 at risk EG0019 events8 affected151 at risk
Heart Failure	Cardiac disorders	Systematic Assessment	EG00040 events26 affected150 at risk EG00139 events26 affected151 at risk
Arterial Non-CNS Thromboembolism	Vascular disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected151 at risk
Venous Thromboembolism Event	Vascular disorders	Systematic Assessment	EG0004 events4 affected150 at risk EG0013 events3 affected151 at risk
Wound Dehiscence	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0011 events1 affected151 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00012 events9 affected150 at risk EG0019 events8 affected151 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0016 events6 affected151 at risk
2 Degree AV Block Type 1	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Abdominal Aortic Aneurysm with claudication	Vascular disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Acute vision loss, non-neurological	Eye disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0005 events4 affected150 at risk EG0011 events1 affected151 at risk
Annuloplasty ring dehiscence	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Bradyarrhythmia requiring pacemaker	Cardiac disorders	Systematic Assessment	EG0005 events5 affected150 at risk EG0012 events2 affected151 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Bradycardia requiring pacemaker	Cardiac disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Broken Bone	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 events2 affected150 at risk EG0011 events1 affected151 at risk
Cardiogenic Shock	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0012 events2 affected151 at risk
Carotid Disease	Cardiac disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected151 at risk
Chest Pain/ACS	Cardiac disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG00115 events10 affected151 at risk
Chest Pain/ACS/PCI	Cardiac disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Coagulopathy/HIT	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected151 at risk
Coagulopathy/HIT (-)	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Contrast induced nephropathy	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Depression and anxiety	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Diabetic Foot Ulcer	Vascular disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected151 at risk
Epistaxis	Vascular disorders	Systematic Assessment	EG0002 events1 affected150 at risk EG0010 events0 affected151 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
GI Bleed/GI Issue	Gastrointestinal disorders	Systematic Assessment	EG0007 events7 affected150 at risk EG0016 events6 affected151 at risk
Gangrenous Toe	Vascular disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Heart Transplant	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0012 events2 affected151 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0010 events0 affected151 at risk
Hypoxia and respiratory insufficiency	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
ICD Implant	Cardiac disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0010 events0 affected151 at risk
Ischemic Bowel	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Ischemic Left hand	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
LV apical cannula clot	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Left superficial femoral artery pseudoaneurysm	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Lower extremity ischemia	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Malfunctioning PM	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Non Sustained VT	Cardiac disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0010 events0 affected151 at risk
Non-healing wound	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Organ Transplant	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Pancytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Peripheral vascular disease	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0015 events3 affected151 at risk
Peripheral vascular disease/BKA	Vascular disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Pill esophagitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Post anesthetic Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Psychosis	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
R/O LV Thrombus	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Renal Calculi	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Small bowel obstruction/ileus	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0011 events1 affected151 at risk
Sternal Non-Union	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Syncope	Cardiac disorders	Systematic Assessment	EG0003 events3 affected150 at risk EG0011 events1 affected151 at risk
Torn aorta	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Hemostasis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Nephrectomy	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Right Axillary hematoma	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Ruptured appendix	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Arrhythmias - Sustained supraventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG00025 events24 affected150 at risk EG00118 events18 affected151 at risk
Hepatic Dysfunction	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Major Infection - Localized	Infections and infestations	Systematic Assessment	EG00019 events13 affected150 at risk EG00111 events9 affected151 at risk
Myocardial infarction - Peri-CABG MI	Cardiac disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Neurological Dysfunction - Toxic Metabolic Encephalopathy	Nervous system disorders	Systematic Assessment	EG0004 events4 affected150 at risk EG0010 events0 affected151 at risk
Neurological Dysfunction - Other*	Nervous system disorders	Systematic Assessment	EG0002 events2 affected150 at risk EG0011 events1 affected151 at risk
Renal dysfunction (no dialysis)	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected150 at risk EG0010 events0 affected151 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Venous Thromboembolism Event	Vascular disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events6 affected150 at risk EG0017 events7 affected151 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0012 events2 affected151 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
GI Bleed/GI Issue	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Hemetemesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Pressure ulcers	Vascular disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Neurological Dysfunction - TIA	Vascular disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Bradyarrhythmia requiring pacemaker	Cardiac disorders	Systematic Assessment	EG0001 events1 affected150 at risk EG0010 events0 affected151 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk
Non-healing wound	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected150 at risk EG0011 events1 affected151 at risk

ID	Term
D008944	Mitral Valve Insufficiency
D003324	Coronary Artery Disease

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D058385	Cardiac Valve Annuloplasty
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures