ViViV Procedure Can Be Supported by Inner Diameter Enlargement Using a High-Pressure Balloon

Objectives: TAVI as valve in valve (ViV) in degenerated stented bioprosthesis has become a routine intervention with various studies demonstrating safety and efficacy. Numerous patients received this procedure but can be expected to suffer from repeated valve degeneration resulting in the need for a new prosthesis within the typical time frame. Valve in valve in valve (ViViV) using another TAVI is seen as a suitable method to treat these high-risk patients. Yet, the internal diameter being a decisive factor for an optimal implantation decreases with each TAVI iteration. Amongst the ideas to address this problem is the fracturing of the valve ring using a high-pressure balloon. However, efficacy and safety of this procedure prior to a ViViV has not yet been evaluated.

Methods: Degenerated commercially available stented biological valves of size 23 mm Medtronic Avalus (MA); Medtronic Hancock II (MH); Edwards Lifesciences Perimount (EP); SJM Trifecta (TF) were investigated separately after installation of a first TAVI, ballooning with a high-pressure balloon (22 mm diameter, maximum pressure of 10 atm) and after second TAVI. True inner diameters (TID) were measured by Hegar stick and valve performance was evaluated in a HKP 2.0 hemodynamic pulse duplicator simulating 70 bpm and 70 mL stroke volume (cardiac output: 4.9 L/min).

Result: TID of MA, EP, and TF were reduced by 2 mm after first TAVI but could be recovered by 1 mm in MA and TF and 2 mm in EP by high pressure balloon. In MH no change in true inner diameter appeared during these steps. This led to the diameters of the final ViViV combination being the same as the ViV in EP and only 1 mm smaller in MA, MH and TF. Mean systolic pressure gradient increased between first and second TAVI in MA (7.7 ± 1.1 to 9.7 ± 0.4 mm Hg, p = 0.001), EP (8.8 ± 0.7 to 9.9 ± 0.5 mm Hg, p = 0.001) and TF (9.1 ± 0.7 to 11.8 ± 0.7 mm Hg, p < 0.001) and decreased in MH (10.6 ± 0.5 to 9.8 ± 0.4 mm Hg, p = 0.001). Measurements of leakage and regurgitation fraction proved a successful positioning of the third prosthesis.

Conclusion: Some valves are more prone to TID reduction than others during repeated ViV maneuvers. Mitigation of TID decrease, however, could be achieved with a high pressure balloon in all those investigated valves showing TID reduction. Mean systolic pressure gradients remained reasonably low, thus demonstrating ViViV being a feasible strategy.

Publication History

Article published online:
19 February 2021