Page 98 - Advanced echocardiography in characterization and management of patients with secondary mitral regurgitation
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Chapter five. MV geometry: The COAPT Trial
treatment arm, and that MitraClip treatment would mitigate the impact from these prognostic risk factors.
Methods
Study design and patient population
Details concerning the COAPT study design and patient population have been published previously (13,15). In brief, HF patients with ischemic or non-ischemic cardiomyopathy and with moderate-to-severe (grade 3+) or severe (grade 4+) secondary MR who remained symptomatic despite the use of maximally-tolerated GDMT were enrolled. Patients were randomized to TMVr using the MitraClip device (Abbott Vascular, Santa Clara, CA) plus GDMT or GDMT alone. Procedural data have been published previously (13). The primary endpoint of the present analysis was the composite of all- cause death or heart failure hospitalization (HFH) at 24-month follow-up. Secondary endpoints included all-cause mortality and HFH alone. The protocol was registered on ClinicalTrials.gov (#NCT01626079) and was approved by the investigational board of each participating center. All patients provided written informed consent. The sponsor participated in site selection and management and in data analysis. The principal investigators had unrestricted access to the data, wrote the manuscript, and vouch for the accuracy and completeness of the data and analyses and for the fidelity of the trial to the protocol.
Echocardiography
Baseline conventional echocardiographic measurements were performed by an independent echocardiographic core laboratory (MedStar Health Research Institute, Washington DC) and have been published previously (13,16). Left and right ventricular dimensions and function were measured according to current recommendations (17,18). MR was quantified using a multiparametric algorithm based on recommendations from the American Society of Echocardiography (13,19). Tricuspid regurgitation (TR) was also graded based on a multiparametric approach consisting of qualitative and semiquantitative parameters (19).
For the present post hoc analysis, mitral valve geometric analysis was performed using commercially available software for offline analysis (TomTec-Arena, version 20.18, 2017). Table 1 and Figures 1 and 2 summarize the mitral valve geometrical variables measured (9,10,20-22). All measurements were done on transthoracic echocardiograph. The measurements were performed per multiple beats if atrial fibrillation was present. The
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