A trial suggests that patients with asymptomatic severe aortic stenosis should undergo early transcatheter aortic valve implantation, but John Mandrola, MD, sees flaws in the study design.
The question being asked in EARLY TAVR is when to intervene on patients with severe AS. In days of old, we deferred aortic valve surgery until major symptoms occurred:— found that early surgical aortic valve replacement in patients with severe asymptomatic AS proved beneficial. The core problem with these trials were the small numbers of patients and events.
Patients were 76 years of age on average; 30% were female; and most notably, they had low surgical risk, with a mean STS-PROM score of 1.8. The reasons for conversion to TAVR in the surveillance arm was almost always progressive symptoms and signs of AS, not acute decompensation. The fatal flaw in EARLY TAVR occurred before the first patient was enrolled. Namely, all patients knew they had severe valvular heart disease. One group gets early surgery; the other group gets no treatment. This, of course, is a reasonable comparison. But the endpoints must be resistant to bias. That was not the case in EARLY TAVR.
EARLY TAVR also found no significant differences in death or stroke. If not for the inclusion of unplanned hospitalization in the primary endpoint, clinical surveillance would have performed similarly to TAVR. There would be little enthusiasm for early intervention. The “old way” of active surveillance would have been confirmed.
Cardiac Surgery Congenital Heart Disease Transcatheter Aortic Valve Replacement TAVR Transcatheter Aortic Valve Implantation TAVI Percutaneous Aortic Valve Replacement Aortic Valve Stroke Cerebrovascular Accident CVA - Cerebrovascular Accident Thromboembolism Aortic Insufficiency Aortic Valve Insufficiency Aortic Regurgitation Anxiety Disorder Anxiety
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