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• W2600510665 abstract "Objective: Evaluation of baseline and 6-month transthoracic echocardiographic (TTE) parameters in patients with Heart Failure with a Preserved Ejection Fraction (HFpEF) treated with a novel device that creates a controlled left to right interatrial shunt (IASD). Methods: Patients with HFpEF, as defined by LV ejection fraction (EF) ≥ 40%, New York Heart Association (NYHA) class II–IV, elevated pulmonary capillary wedge pressure (PAWP, ≥ 15 mmHg at rest, or ≥ 25 during bike exercise), central venous pressure (CVP) <15 at rest mmHg were enrolled in the study and underwent IASD implantation. Complete per protocol study TTE were performed at the implant sites and analyzed at an independent echo core laboratory. Results: Of 102 patients enrolled, 66 qualified with mean age 69 ± 8.3 years and 65% female. Baseline hemodynamics includes resting and exercise CVP of 9.0 ± 3.7 and 17.5 ± 6.2 mmHg respectively. Resting and exercise PAWP were 17.4 ± 5.3 and 34.0 ± 8.6 mmHg respectively. 57 underwent IASD implantation. Independent core lab analysis of resting TTE at enrollment and at 6-month follow up (6 MFU) demonstrated no evidence of IASD device thrombus, migration, or excessive mobility. Left to right color Doppler flow was present in all implanted patients. At 6 MFU, an increase in estimated mean RA volume indexed to BSA (4.6 cm^3/m2, p = 0.018) was noted. Increased estimated mean RV diastolic volume indexed to BSA was also observed (5.06 cm^3/m2, p <.001). Reduction in estimated LV mean diastolic volume indexed to BSA (6.15 cm^3/m2, p =0.02) was noted. There was no significant change in diastolic LA volume indexed to BSA (0.16cm^3/m2, p =0.939). There was no significant change in RV systolic function as assessed by TAPSE at 6 MFU (p = 0.973). Conclusion: At 6 MFU post, safe implant of the IASD in HFpEF patients was achieved with Doppler left to right shunt flow present and no device malfunction or thrombus. Small increases in estimated mean RA and RV diastolic volume indexed to BSA were observed with the creation of a left to right shunt. Similar reduction in mean LV diastolic volume indexed to BSA was noted. There was no significant change in LA volume indexed to BSA. There was no significant change in RV systolic function as assessed by TAPSE. These findings indicate that a left to right interatrial shunt can be safely created with the iASD with a small impact on left and right ventricular estimated volumes and no impact on RV function as assessed by TAPSE." @default.
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• W2600510665 date "2016-06-01" @default.
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• W2600510665 title "176-76: Baseline characteristics and 6-month echocardiographic assessment of chamber size in the REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure Trial: the first HFpEF device trial" @default.
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