Objectives
To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk.
Background
The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self‐expanding system with supra‐annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm.
Methods
The GENESIS trial was a prospective, multi‐center, single‐arm, 6 month follow‐up study conducted in India. The primary performance endpoint was device success defined as per VARC‐II criteria at 30 days. The primary safety endpoint was all‐cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee.
Results
Forty high‐risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7 ± 0.2 to 2.3 ± 0.6 cm2 at 30 days and to 2.2 ± 0.7 cm2 at 6 months (p < .0001). Mean aortic valve gradient decreased from 53.5 ± 18.1 to 8.9 ± 4.9 mmHg at 30 days and to 7.6 ± 2.7 mmHg at 6 months (p < .0001). The rate of new permanent pacemaker implantation was 7.5% at 30 days, and no patient had more than mild paravalvular leak at 6 months. The 30 days and 6 month all‐cause mortality was 10.0 and 17.5%, cardiovascular mortality 7.5 and 7.5%, device‐related mortality 5.0 and 5.0%, respectively. No patients had stroke up to 6 months.
Conclusions
The GENESIS trial demonstrated high efficacy of the self‐expanding Hydra THV. The cardiovascular mortality rate of 7.5% may partly be explained by the inclusion of some centres with no or limited previous experience in transcatheter aortic valve implantation.
A 50-year-old man was admitted with high-risk acute coronary syndrome with enzyme elevation. A coronary angiogram revealed a critical 90% stenosis of the proximal left anterior descending artery. The lesion was predilated and a 3 mm × 18 mm bare metal stent was deployed at 14 atm. After stent deployment, balloon passage inside the stent was difficult. For better visualization of the stent, StentBoost (Philips Medical Systems, Netherlands) was used. With the balloon markers located within the stented segment, roughly 40 frames of digital cine were acquired without injection of contrast at 15 frames/s. StentBoost-augmented images (Figure 1) revealed that the stent had fractured into two pieces, which was not apparent on ordinary cine angiography. Subsequently, a second stent was deployed across the fractured stent.Stent strut fracture is a rare but important complication that can lead to serious consequences, such as stent thrombosis, if it is not treated in time. Stent fracture is a rare but important cause of restenosis in the drug-eluting stent era (1). In the present case, StentBoost enabled the diagnosis of this complication, which could then be treated. Stent strut fracture has been diagnosed previously by means of intravascular ultrasound (1), multislice computed tomography (2) and optical coherence tomography (3).StentBoost is a novel fluoroscopic stent visualization technique that creates a high-quality image of deployed stents by superimposing motion-corrected acquisition frames, thus giving a clearer image of the stent. The balloon markers must be in the frame. StentBoost does not require any additional expensive hardware and it can give important information about stent position, placement and complications, as illustrated in the present case.
imageS in cardiology
Primary cardiac neoplasms are rare. Rhabdomyoma is the most common benign congenital tumor found in infancy and has a tendency for spontaneous regression. We report a case of a cardiac rhabdomyoma in a symptomatic neonate in whom serial echocardiography was used for diagnosis and documentation of initial regression as early as 1 month.
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