A total of 7,504 patients underwent TMVR at 240 sites during the study period. KCCQ-OS data were available for 4,226 patients at 30 days. Among these patients, the average KCCQ-OS score increased from 41.9 at baseline to 66.7 at 30 days. Average KCCQ-OS scores also increased for the 1,124 patients for whom one-year data were available – from 42.3 at baseline to 71.4 at one year.

Lower KCCQ-OS scores, a history of atrial fibrillation or severe lung disease, presence of a permanent pacemaker and home oxygen use were associated with poorer health status at 30 days. At one year, 54.2 percent of patients were alive and well and 21.9 percent had consistently poor health, defined as a KCCQ-OS score of less than 60. The one-year mortality rate was 23 percent.

Although the long-term mortality rate was high, the study suggests that TMVR patients who are living one year after the procedure have strong health benefits that are consistent across patient populations. In addition, the study's findings that certain factors are associated with lower 30-day health status could help improve patient selection and expectations for recovery, the authors conclude.

"The ACC/STS TVT Registry is a national learning machine that provides all stakeholders with new insights into these therapies via multiple publications and presentations," commented John D. Carroll, MD, FACC, chair of the ACC/STS TVT Registry. "The value of the registry has been enormous for all stakeholders," he adds.

Arnold SV, Li Z, Vemulapalli S, et al. JAMA Cardiol 2018;3:1151-9.

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Patients with very low LV ejection fraction (LVEF), compared with those with low LVEF, exhibited a higher rate of prior myocardial infarction (MI) (56 [43.8 percent] vs. 52 [31.5 percent]; p=0.03) and had more frequently concomitant moderate to severe aortic regurgitation (41 [32.0 percent] vs. 32 [19.4 percent]; p=0.01) and moderate to severe mitral regurgitation (55 [43.0 percent] vs. 48 [29.1 percent]; p=0.01).

The 30-day mortality rate was 4.1 percent, with no differences between groups (very low LVEF, 4.7 percent; low LVEF, 3.6 percent; p=0.65). There were also no differences between groups in the rate of periprocedural complications. At a median follow-up of 23 months (interquartile range [IQR], 6-38), 45.1 percent of patients had died, with no differences between the very low LVEF group (44.5 percent) and the low LVEF group (45.5 percent); hazard ratio [HR], 0.96 [95 percent CI, 0.61-1.53]; p=0.88).

At one-year follow-up, researchers observed a significant increase in LVEF (22 percent; p<0.001) and the increase was greater in the very low LVEF group (33 percent; p<0.001) compared with the low LVEF group (14 percent; p<0.001).

"In patients with LFLG AS and severe LV dysfunction, TAVR was feasible and was associated with similar clinical outcomes in those patients with only mildly depressed LVEF function," the authors conclude. "Importantly, most patients demonstrated a significant improvement in their LVEF over time, irrespective of the degree of baseline LV dysfunction and the presence or lack of contractile reserve."

Maes F, Lerakis S, Barbosa Ribeiro H, et al. JAMA Cardiol 2018;Dec 19:[Epub ahead of print].

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At initial examination, patients with HFpEF were older (71±9 years) and obese (body mass index [BMI] 32±7 kg/m2) and had typical comorbidities such as hypertension, atrial fibrillation (AFib) and coronary artery disease, as in the general population. Over a median period of 4.0 years (interquartile range, 2.1-6.1), there was a 10 percent decline in RV fractional area change and 21 percent increase in RV diastolic area (both p<0.0001). These changes greatly exceeded corresponding changes in the LV.

The prevalence of tricuspid regurgitation increased by 45 percent. Of 238 patients with normal RV function at initial examination, 23 percent (n=55) developed RV dysfunction during follow-up. Development of RV dysfunction was associated with both prevalent and incident AFib, higher body weight, coronary disease, higher pulmonary artery and LV filling pressures, and RV dilation.

In an unadjusted Cox model, the development of RV dysfunction was associated with an 80 percent increased risk of death (hazard ratio [HR], 1.82; 95 percent confidence interval [CI], 1.01-3.19; p=0.04). Development of RV dysfunction remained significantly associated with mortality after adjustment for other established risk factors associated with mortality in HFpEF, including age, BMI, AFib, ejection fraction, and E/e' ratio (adjusted HR, 1.89; 95 percent CI, 1.01-3.44; p=0.04).

The authors write that further research is required to evaluate whether interventions targeting modifiable risk factors identified for incident RV dysfunction, including abnormal hemodynamics, AFib, coronary disease and obesity, can prevent RV dysfunction and thus improve outcomes.

Obokata M, Reddy YN, Melenovsky V, et al. Eur Heart J 2018;Dec 12:[Epub ahead of print].

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