Comprehensive Assessment of Frailty

CAF, Comprehensive assessment of frailty. A scoring system of the patients physical status. By smaller physical test of balance, strength and walking speed.

CAF, Comprehensive assessment of frailty

Frailty In Cardiac Surgery Copenhagen Study

Christian Holdflod Møller

Doctor of Medical Science

Rigshospitalet, Denmark

Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement

Participants will receive optimal medical therapy alone

Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement

1 Medical Therapy Plus Surgical Repair

2 Medical Therapy Only

Total

Standard deviation for individual arms could not be calculated because only 1 participant was evaluated in each arm. Total SD was calculated.

Sex: Female, Male

Region of Enrollment

1 Medical Therapy Plus Surgery

Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)

Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.

Optimal Medical Therapy Plus Surgical MV Repair

Participants will receive optimal medical therapy alone
Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Optimal Medical Therapy Alone

Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.

Optimal Medical Therapy Plus 18 Month Delayed MVR

Peak VO2

The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.

Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or signific

Optimal Medical Therapy Plus Surgical MVR

Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for rup

Change in 6-minute Walk Test

Change in MLHF score. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.

Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Change in Minnesota Living With Heart Failure (MLHF) Score

Total days alive and not hospitalized by 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.

Total Days Alive and Total Days Not Hospitalized

Total all-cause mortality at 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.

Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement
Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.
Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Total Mortality (All Causes)

Perioperative Mortality

Overall Study

Mary Ann Sellers

Mitral Valve Insufficiency

Heart Failure

Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. The ring size will be between 24 mm and 27 mm in the anteroposterior diameter. Annular ring sutures will be placed circumferentially approximately 1 mm off the hinge point between the leaflet and the atrial tissue. The total number of sutures will vary between 4 and 7 sutures anteriorly, while 8 to 12 sutures will be utilized for the posterior segment of the annulus. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.

Surgical mitral valvuloplasty with placement of annular ring (SMVR)

Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Optimal medical therapy (OMT)

Morehouse School of Medicine

Brigham and Women's Hospital

Minnesota Heart Failure Network

Mayo Clinic

Duke University Medical Center

Baylor College of Medicine

University of Utah Health Sciences Center

University of Vermont - Fletcher Allen Health Care

Montreal Heart Institute

Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure

Surgery Versus Medical Treatment Alone for Patients With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure: SMMART-HF

Duke University

National Heart, Lung, and Blood Institute (NHLBI)

Heart Failure Clinical Research Network

Hypertrophic Cardiomyopathy

Left Ventricular Hypertrophy

Myocardial Ischemia

Losartan

National Heart, Lung and Blood Institute (NHLBI)

Long Term Effects of Enalapril and Losartan on Genetic Heart Disease

Double-Blind, Placebo-Controlled Study of the Long Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Hypertrophy in Non-Obstructive HCM

cardiomegaly/fatigue

Frailty In Cardiac Surgery Copenhagen Study

Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure

Long Term Effects of Enalapril and Losartan on Genetic Heart Disease

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