No-React® Injectable BioPulmonic™ valves re-evaluated: discouraging follow-up results

Abstract

These mid-term results after implantation of the No-React® Injectable BioPulmonic™ valve are disappointing. Graft failure was mainly due to neointimal formation and valve malposition.

Bilateral Lung transplantation for Pulmonary Artery Aneurysm with Severe Pulmonary Hypertension: An Evolution or A Revolution?

“…The long-term outcome of this device, which is prone to early failure (85% failure rate at 5.2 years), is uncertain. 17 Currently, there is no clear guideline for treating patients with PAA because the rarity of the disease, and the paucity of data on its natural history and long-term outcomes. Treatment options include close observation, medical treatment, repair of the aneurysm, and in cases associated with severe pulmonary hypertension, bilateral lung or combined heart-lung transplantation.…”

“…13 The problem with this valve is that it has very poor long-term outcome when deployed percutaneously in pediatric patients due to either malposition or neointimal proliferation. 17 It remains to be seen how this valve performs in an adult patient on immunosuppression.…”

Surgical reconstruction of the right ventricular outflow tract -- The clock is still ticking

“…This is a retrospective, single center study with no control group and a relatively small number of patients; the indirect evidence that no patient had fever after switching to bovine jugular vein conduit does not come from a statistical analysis and it must be considered at best as speculative. Comparison with the current literature is not straightforward, as the only published paper focusing on the use of this particular conduit on congenital patients is the study from Marianeschi and colleagues from 2001 4 ; all previous papers investigating BioIntegral devices mainly concentrated on mid-term rather than short-term results [5][6][7][8][9] . Finally, the median follow-up of 14.5 months is short and a trend towards higher gradients in patients who experienced fever is the only follow-up information provided by the Authors.…”

“…Multiple papers focusing on the aortic BioIntegral Bioconduit? in the adult population or on similar devices implanted in the pulmonary position with a long enough follow-up, reported significant rates of adverse valve-related events [5][6][7][8][9] . Moreover, bioprostheses typically degenerate earlier in pediatric patients compared to adult patients, and a similar trend can be expected even in devices undergoing the No-React(r) treatment.…”

Bilateral lung transplantation for pulmonary artery aneurysm with severe pulmonary hypertension: An evolution or a revolution?

“…However, this is the first reported case of using such a bioprosthesis in this clinical scenario. The long‐term outcome of this device, which is prone to early failure (85% failure rate at 5.2 years), is uncertain 17 …”