February 02, 2016
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Transfemoral TAVR shows reductions in mortality, paravalvular leak

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From 2009 to 2012, significant decreases in moderate or severe paravalvular leak and longer-term all-cause mortality have been observed in patients undergoing transfemoral transcatheter aortic valve replacement, according to study results.

Researchers evaluated 1,063 participants in the PARTNER trial nonrandomized continued access registry who underwent transfemoral TAVR for severe native trileaflet aortic stenosis. Participants were grouped into tertiles based on procedure date: tertile 1 (n = 353; March 24, 2009-July 21, 2010); tertile 2 (n = 355; July 22, 2010-March 10, 2011); and tertile 3 (n = 355; March 11, 2011-Jan. 10, 2012).

The study’s primary endpoint was defined as the frequency of all-cause mortality at 30 days, 6 months, 1 year and 2 years, and 30-day nonfatal complications, including any stroke, any aortic valve repeat intervention, major bleeding and major vascular complications.

The researchers found that between the tertiles, the rates of diabetes, dyslipidemia, hypertension, congestive HF, previous CAD or CABG, renal disease, liver disease, pulmonary hypertension or the mean Mini-Mental Status Examination scores were comparable. However, compared with tertile 2 or tertile 3, patients in tertile 1 had higher frequency of previous stroke, transient ischemic attack, porcelain aorta, chronic obstructive pulmonary disease, and previous chest wall radiation and chest wall deformities. A significant decrease was seen in the prevalence of patients considered inoperable who underwent TAVR between tertile 1 and tertile 3. During enrollment, there was a significant improvement in device and procedural success, and percutaneous access showed a significant increase, according to the researchers.

Although no difference was seen in all-cause mortality at 30 days, 6-month mortality showed a decrease across tertiles (tertile 1, 16.7%; tertile 2, 13.9%; tertile 3, 10.2%; P = .01). Decreases across tertiles also were seen at 1 year (tertile 1, 22.7%; tertile 2, 21.4%; tertile 3, 14.4%; P = .005) and 2 years (tertile 1, 34.9%; tertile 2, 32.6%; tertile 3, 24.2%; P = .005). At 30 days, no difference was seen in any stroke (tertile 1, 3.5%; tertile 2, 4%; tertile 3, 3.4%; P = .89), major bleeding (tertile 1, 8.6%; tertile 2, 6.3%; tertile 3, 6.2%; P = .38), major vascular complications (tertile 1, 9.7%; tertile 2, 6.2%; tertile 3, 8.2%; P = .24), any aortic valve reintervention (tertile 1, 0.3%; tertile 2, 0.9%; tertile 3, 1.4%; P = .24) or the composite of these complications (tertile 1, 17.1%; tertile 2, 13.3%; tertile 3, 15.2%; P = .39). A decrease was seen, however, in the incidence of 30-day postprocedural moderate or severe paravalvular leak (tertile 1, 19.2%; tertile 2, 13.8%; tertile 3, 10.1%; P = .004).

“All-cause mortality after TAVR can be lowered. In the present analysis, selection of patients with fewer adverse clinical features … and lowering of paravalvular regurgitation … were related to a significant decline in post-TAVR mortality through 2 years of follow-up,” the researchers wrote. “We found no reduction in the frequency of nonfatal major complications, however, which may be a target for further reduction of late mortality after TAVR.” – by Jennifer Byrne

Disclosure: The PARTNER trial was funded by Edwards Lifesciences. Please see the full study for a list of all of the researchers’ relevant financial disclosures.