6
•
The safety and effectiveness have not been established for implanting the transcatheter valve
inside a stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic
aortic valve.
•
Residual mean gradient may be higher in a "TAV-in-SAV" configuration than that observed
following implantation of the valve inside a native aortic annulus using the same size device.
Patients with elevated mean gradient post procedure should be carefully followed. It is
important that the manufacturer, model and size of the preexisting surgical bioprosthetic aortic
valve be determined, so that the appropriate valve can be implanted and a prosthesis-patient
mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to
make as accurate a determination of the internal orifice as possible.
6.0
Potential Adverse Events
Potential risks associated with the overall procedure including potential access complications
associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of
conscious sedation and/or general anesthesia, and the use of angiography:
•
Death
•
Stroke/transient ischemic attack, clusters or neurological deficit
•
Paralysis
•
Permanent disability
•
Respiratory insufficiency or respiratory failure
•
Hemorrhage requiring transfusion or intervention
•
Cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium or
valvular structures that may require intervention
•
Pericardial effusion or cardiac tamponade
•
Embolization including air, calcific valve material or thrombus
•
Infection including septicemia and endocarditis
•
Heart failure
•
Myocardial infarction
•
Renal insufficiency or renal failure
•
Conduction system defect which may require a permanent pacemaker
•
Arrhythmia
•
Retroperitoneal bleed
•
AV fistula or pseudoaneurysm
•
Reoperation
•
Ischemia or nerve injury
•
Restenosis
•
Pulmonary edema
•
Pleural effusion
•
Bleeding
•
Anemia
•
Abnormal lab values (including electrolyte imbalance)