Real-World Study on Valve Replacement Finds It More Dangerous than Surgery


An analysis of thousands of patients in Germany taken from a national registry found interventional procedures more dangerous than surgery for severe symptomatic aortic valve stenosis. But there may have been confounding factors.

Despite a large new study from Germany, the debate over which is better, surgery or interventional procedures to treat aortic valve stenosis has yet to be settled.

Reporting today at the American Heart Association’s Scientific Sessions 2016 in New Orleans, LA, Nicholas Werner, MD, and colleagues from Medical Clinic B, Medizinische Klinikum Ludwigshafen Germany offered research on outcomes from heart patients in the German Aortic Valve Registry (GARY).

At first glance, the results appear to favor surgery.

The GARY results showed that patients who had transcatheter aortic valve implantation (TAVI) at 88 centers in Germany had a 3.8% in-hospital death rate versus 2.6 among in-hospital surgical patients and 16.6% at one year after TAVI versus 8.9% one year after surgical replacement.

The unadjusted death rate was higher after TAVI and a significant difference in one-year mortality rate persisted between the two groups even after propensity score analysis.

But the difference could be explained by factors not related entirely to treatment.

For one thing, the patients who got TAVI may have been too frail for surgery, often due to advanced age. In the GARY study, all were patients with intermediate surgical risk who got isolated interventional or surgical aortic valve replacement (SAVR) for severe symptomatic aortic valve stenosis.

Of 5,997 patients in the study 4,101 had TAVI and 1,896 had SAVR.

“The patients who had TAVI were older, more were female, and were at higher risk of myocardial infarction,” Werner said at a news conference this morning.

Physician judgment over which procedure to use also may have been a confounding factor, as could the fact that some centers’ heart teams were more experienced and simply better at doing their procedures.

“It is not possible to adjust for medical opinion,” Werner said.

Commenting on the study, Craig Smith, MD, of New York Hospital/Columbia, an investigator in the PARTNER II studies on the same issue (the study found TAVI was non-inferior to SAVR) said while the jury is still out on the question of which is better, the latest data from NY State’s registry of heart procedures’ results shows “a two- to three-fold higher risk for surgery.”

He agreed that a lot depended on the where the patient was treated and the skill of the physicians.

Smith commended the investigators on getting “real world” results vs. findings from randomly controlled trials of selected populations’ results after procedures usually done at specialty centers.

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