Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation (HYSPANIA)

Hydra Transcatheter Heart Valve (THV)

设备：Hydra THV

Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.

Assessment of the success rate of implantation

Assessment of the success rate of implantation defined by:

• Absence of mortality during the procedure or within 24 hours after implantation; and
• Correct anatomical positioning of a single valve; and
• Absence of mismatch, defined as effective aortic valve area > 0.85 cm²/m²and;
• Mean gradient < 20 mm Hg or peak velocity < 3 m/s and;
• Absence of moderate or severe aortic regurgitation

Success of the procedure

Composite outcome measures defined as a the absence of intra-procedural mortality or complications during implantation, such as: failure to implant the valve at the annulus level, the need to implant more than one valve (valve-in-valve implantation or implantation of a second valve due to embolisation of the first) or surgical intervention on the aortic valve due to severe aortic insufficiency or complications of the procedure.

心血管死亡率

心血管死亡发生率

All cause mortality

Incidence of all cause mortality

All cause mortality

Incidence of all cause mortality

All cause mortality

Incidence of all cause mortality

Cardiovascular mortality

Incidence of cardiovascular mortality

Cardiovascular mortality

Incidence of cardiovascular mortality

Stroke

Incidence of Stroke

Stroke

Incidence of Stroke

Stroke

Incidence of Stroke

Stroke with disabling

Incidence of Stroke with disabling

Stroke with disabling

Incidence of Stroke with disabling

Stroke with disabling

Incidence of Stroke with disabling

Stroke with non disabling

Incidence of Stroke with non disabling

Stroke with non disabling

Incidence of Stroke with non disabling

Stroke with non disabling

Incidence of Stroke with non disabling

Acute myocardial infarction

Incidence of acute myocardial infarction

Acute myocardial infarction

Incidence of acute myocardial infarction

Acute myocardial infarction

Incidence of acute myocardial infarction

Coronary occlusion

Incidence of coronary occlusion

Coronary occlusion

Incidence of coronary occlusion

Coronary occlusion

Incidence of coronary occlusion

Haemorrhagic complications

Incidence of haemorrhagic complications

Haemorrhagic complications

Incidence of haemorrhagic complications

Haemorrhagic complications

Incidence of haemorrhagic complications

Vascular complications

Incidence of vascular complications

Vascular complications

Incidence of vascular complications

Vascular complications

Incidence of vascular complications

Acute renal failure

Incidence of Acute renal failure

Acute renal failure

Incidence of Acute renal failure

Acute renal failure

Incidence of Acute renal failure

Conduction disturbances

Incidence of conduction disturbances

Conduction disturbances

Incidence of conduction disturbances

Conduction disturbances

Incidence of conduction disturbances

Arrhythmias

Incidence of Arrhythmias

Arrhythmias

Incidence of Arrhythmias

Arrhythmias

Incidence of Arrhythmias

Implantation of a new permanent pacemaker

Incidence of Implantation of a new permanent pacemaker

Implantation of a new permanent pacemaker

Incidence of Implantation of a new permanent pacemaker

Implantation of a new permanent pacemaker

Incidence of Implantation of a new permanent pacemaker

Combined safety event at 30 days defined by Valve Academic Research Consortium 3 (VARC-3) criteria

Proportion of patients with freedom from: all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device.

New York Heart Association (NYHA)

Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure

New York Heart Association (NYHA)

Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure

New York Heart Association (NYHA)

Proportion of patients with modification of NYHA before the procedure and its modification after the procedure

Echocardiographic Valve Dysfunction Assessment

Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction:

Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency

Echocardiographic Valve Dysfunction Assessment

Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction:

Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency

Echocardiographic Valve Dysfunction Assessment

Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction:

Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency