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Lower albumin, nontransfemoral access route predict guideline-defined TAVI futility

Jairia Dela Cruz
11 Oct 2018

Futility of transcatheter aortic valve implantation (TAVI), defined as mortality or lack of objective symptomatic improvement in New York Heart Association (NYHA) class within 1 year, is strongly associated with lower baseline albumin levels and nontransfemoral access route, according to a recent study.

“These predicting factors could be used to inform each specific patient on his or her prognosed benefit–risk and benefit–cost trade-off in order to improve shared decision-making and manage the patient’s expectations,” the investigators said.

The analysis included a single-centre cohort of 741 consecutive patients (median age 81.9 years; 44 percent male; mean BMI, 27.7 kg/m2) who underwent TAVI. Guideline-defined futile TAVI occurred in 212 patients (28.6 percent), among whom 113 (53.3 percent) died within 1 year after the procedure and 99 (46.7 percent) showed no symptomatic improvement. [Open Heart 2018;doi:10.1136/openhrt-2018-000879]

Compared with nonfutile TAVI controls (n=529), the futile group had significantly higher estimated operative mortality risk (Society of Thoracic Surgeons Predicted Risk of Mortality, 6.15 percent vs 5.23 percent; p=0.017; EuroSCORE II, 6.64 percent vs 5.40 percent; p=0.002).

On multivariate logistic regression analysis, higher baseline albumin levels and transfemoral access route showed a protective association with futile TAVI. The corresponding odds ratios (ORs) were 0.93 (0.89–0.97) and 0.53 (0.37–0.76; p<0.001 for both).

“Thus, lower levels of albumin and nontransfemoral access route increased the risk for futile TAVI,” the investigators noted.

Other factors independently predictive of 1-year mortality were lower estimated glomerular filtration rate (OR, 0.99; p=0.035), atrial fibrillation (OR, 0.99; p=0.035), low-flow–low-gradient aortic stenosis (OR, 1.84; p=0.008) and lower BMI (per point kg/m2: OR, 0.93; p=0.005). No significant predictors for symptomatic improvement based on NYHA class were found.

Meanwhile, patient-reported outcome measures (PROMs; n=507) were mostly favourable. Most patients (68.6 percent) reported experiencing a >50 percent remedy of their main symptom, without significant difference between the group of patients with vs without symptomatic improvement. The vast majority said they would choose to undergo TAVI again (90.6 percent in the group with symptomatic improvement vs 86.2 percent in the group without symptomatic improvement; p=0.375).

Despite the presence of several limitations, including those inherent to the study design, the present data shed new light on the actual and the patient-experienced effects of TAVI treatment, as well as further elucidate the baseline characteristics predicting futile TAVI according to the current guidelines.

The investigators pointed out that the futility criteria for TAVI could be too strict, in view of the fact that although guideline-defined futile TAVI occurs frequently in the cohort, the overall survival is very acceptable and the patients’ opinion about TAVI after the treatment is mostly positive.

“Incorporating PROMs into a new TAVI futility definition would lower the amount of actual ‘futile’ TAVI procedures. Furthermore, the current warranted 1-year life expectancy threshold is merely based on expert opinion. Since major complications after TAVI are decreasing strongly, as do the costs, this threshold could be debated and become more patient centred,” they said.

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