TABERNACL: Temporary Hemodynamic Stabilization In Vivo.

Background: Acute aortic regurgitation is life-threatening with few nonsurgical options for immediate stabilization. We propose Trans-Aortic Balloon to Ease Regurgitation Applying Counter-Pulsation (TABERNACL), a simple, on-table temporary valve using commercially available equipment to temporize acute severe aortic regurgitation.
Methods: We hypothesize that an appropriately sized commercial balloon dilatation catheter-straddling the aortic annulus and connected to a counterpulsation console-can serve as a temporizing valve to restore hemodynamic stability in acute aortic regurgitation. We performed benchtop testing of valvuloplasty, angioplasty, and sizing balloons as counterpulsation balloons. TABERNACL was assessed in vivo in a porcine model of acute aortic regurgitation (n=8). We also tested a static undersized, continuously inflated transvalvular balloon as a spacer intended physically to obstruct the regurgitant orifice.
Results: Benchtop testing identified that Tyshak II and PTS sizing (NuMed Braun) balloon catheters performed adequately as temporary valves (ie, complete inflation and deflation with each cycle) and resisted fatigue, in contrast to others. When TABERNACL was used in the acute severe regurgitation animals, there was immediate hemodynamic improvement, with a significant 35% increase in diastolic aortic pressure by 16 mm Hg ([95% CI, 7-25] P =0.0056), 34% reduction in left ventricular end-diastolic pressure by -7 mm Hg ([95% CI, -10 to -5] P =0.0006), improvement in the aortic diastolic index by 0.28 ([95% CI, 0.18-0.39] P =0.0009), and reversal of electrocardiographic myocardial ischemia. As an alternative, static balloon inflation across the aortic valve stabilized regurgitation hemodynamics at the expense of a new aortic gradient and caused excessive ectopy from balloon movement in the left ventricular outflow tract.
Conclusions: TABERNACL improves hemodynamics and reduces coronary ischemia by electrocardiography in animals with acute severe aortic regurgitation. TABERNACL valves obstruct the diastolic regurgitant orifice without systolic obstruction. This may prove a lifesaving bridge to definitive valve replacement therapy.
Competing Interests: Disclosures Dr Rogers reports consulting from Edwards Lifesciences, Medtronic, Boston Scientific, and Transmural Systems; is on the advisory board at Medtronic and Boston Scientific; reports equity interest in Transmural Systems; and reports intellectual property (coinventor on patents), assigned to the National Institutes of Health (NIH), for transcatheter electrosurgery devices. Dr Khan reports educational grants from Abbott, Boston Scientific, Edwards Lifesciences, and Philips; is a proctor at Edwards Lifesciences and Medtronic; reports equity interest in Transmural Systems; and reports intellectual property (coinventor on patents), assigned to NIH, for transcatheter electrosurgery devices. The other authors report no conflicts.