Outcomes tied to residual leak after percutaneous PVL closure
medwireNews: Achieving mild or no leak after percutaneous closure of paravalvular leak (PVL) is critical for patient prognosis, shows an analysis of procedures that include a high proportion of oblong devices.
Oblong devices “carry a theoretical advantage” over circular ones, say Patrick Calvert (Papworth Hospital NHS Foundation Trust, Cambridge, UK) and study co-authors. As such, they became popular with operators in the UK and Ireland study, accounting for 72% of devices used after they became available and about two-thirds overall.
Overall, percutaneous closure was a successful procedure, says the team, improving the proportions of patients with severe, moderate or mild PVL from 61.0%, 34.0% and 5.7%, respectively, to 6.7%, 18.6% and 41.4%, with the leak resolving completely in 33.3%.
In line with this, patients’ average New York Heart Association function class improved from 2.7 to 1.6.
Patients had a nonsignificantly increased chance of having less leak and less severe functional symptoms if treated with an oblong rather than a circular device. Both oblong devices used in this study are approved for PVL closure in Europe, but not the USA.
The team assessed outcomes of 308 percutaneous closures in 259 patients in all 20 centres that perform the procedure in the UK and Ireland. PVL closure was performed a median of 4.7 years after the initial procedure, which was surgery for most patients, although 5% had undergone transcatheter aortic valve replacement.
Overall in-hospital mortality was 3.9%, which the researchers say compares favourably with the reported surgical mortality of around 10%. This differed according to the urgency of the procedure, however, with 50.0% of the four patients who had an emergency procedure dying in hospital, compared with 6.8% of the 45 who had an urgent procedure and just 2.9% of the 209 who underwent elective PVL closure.
Despite the good short-term outcomes, 24.8% of patients had a major adverse cardiovascular event (MACE) over a median 110 days of follow-up, with around two-thirds of these events being death. The poor longer-term prognosis for these patients “probably reflects their co-morbidities”, writes the team in Circulation.
Of note, the only factor significantly and independently associated with both MACE and death was the degree of residual leak after PVL closure, with moderate/severe leak increasing the risk of these outcomes around threefold.
“As such it seems that achieving a PVL no greater than mild in severity at follow up is key to achieving a good outcome”, conclude the researchers.
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