Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003) and bleeding (p < 0.001), but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57 percent to 2.15 percent), bleeding (9.56 percent to 5.08 percent), vascular complications (6.11 percent to 4.20 percent) and stroke (2.03 percent to 1.66 percent). These rates were calculated for the “average” patient who carries the average characteristics of the overall study population.

"[T]he information from this report might help updating recommendations of institutional and operator requirements." — Alain Cribier, MD, FACC, et al

The association between TAVR volume and outcomes was most pronounced in the first 100 cases, indicating that there may be an early learning curve for the procedure. Beyond the initial 100 cases, procedural risk continued to decline but at a more gradual rate.

In an accompanying editorial, Alain Cribier, MD, FACC, et al., write that, “the information from this report might help updating recommendations of institutional and operator requirements when planning for programmatic expansion in the United States. Concentrating experience in high-volume centers should be favored to improve outcomes, more particularly when TAVR is likely to expand to lower-risk or younger patients.”

Carroll JD, Vemulapalli S, Dai D, et al. J Am Coll Cardiol 2017;70:29-41.

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They also had a lower rate of the primary endpoint of death, non-fatal stroke and re-hospitalization (57 vs. 13 percent). All patients had an ejection fraction <40 percent, >83 percent were highly symptomatic and one-third developed intracardiac thrombi.

Early detection of heart problems is needed in this population to prevent further deterioration of the MA-associated cardiomyopathy along with recognition of the long-term cardiovascular consequences of this growing epidemic.

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In subgroups defined by the SHFM and SPRM scores, the researchers found that 25 percent of patients with ICDs had a 40 percent reduction in mortality during the follow-up period. Another 25 percent of ICD patients did not receive significant survival benefits; these patients were likely to have a 5.7 percent or less predicted annual risk of death and predicted proportional risk of sudden death at 50 percent or less. The remaining 50 percent of patients with ICDs fell somewhere in between for survival benefits.

"Our contemporary ‘one size fits all’ approach to ICD implantation does not appear to be a clinically or cost effective strategy in sudden death prevention."

The authors conclude that “the SHFM provided a highly effective measure of HF outcomes, whereas the SPRM provided a powerful measure of the proportional risk of sudden death.”

In an editorial comment, Scott D. Solomon, MD, FACC, and Neal A. Chatterjee, MD, state, “By highlighting the need to look beyond absolute risk, Bilchick et al., have offered us an important step forward in sudden death prevention.” They explain that “our contemporary ‘one size fits all’ approach to ICD implantation does not appear to be a clinically or cost effective strategy in sudden death prevention.” They conclude that “By broadening the scope of sudden death prevention tools, we could begin to consider more flexible and individualized approaches to risk reduction.”

Bilchick KC, Wang Y, Cheng A, et al. J Am Coll Cardiol 2017;69:2606-18.

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