Clinical evaluation of the Hydra self-expanding transcatheter aortic valve: 6 month results from the GENESIS trial.

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.

Balloon Mitral Valvuloplasty in Mirror Image Dextrocardia with Rheumatic Mitral Stenosis with Suprasystemic Pulmonary Arterial Hypertension.

32 years old male with history of mirror image dextrocardia with situs inversus and history of rheumatic fever at age of 12 years on penicillin prophylaxis till 25 years of age presented with history of dyspnea on exertion NYHA class 2 since last five years. Cardiac colour Doppler 5 years back was suggestive of rheumatic mitral stenosis with mitral valve area 2 cm2 with mirror image dextrocardia with mild pulmonary arteriolar hypertension in normal sinus rhythm. Patient was put on medications and was advised regular follow up. Patient did not follow up regularly. Cardiac colour doppler 5 years later showed mitral valve area of 0.8 cm2 with suprasystemic pulmonary arterial hypertension of 130 mmhg . Hence was advised percutaneous balloon mitral valvuloplasty. Balloon mitral valvuloplasty was done successfully without inverting the images on fluoroscopy using left femoral approach. Post balloon mitral valvuloplasty mitral valve area increased significantly with mild mitral regurgitation and regression of pulmonary arterial pressures to half the original values.

Occurrence of "J waves" in 12-lead ECG as a marker of acute ischemia and their cellular basis.

The "J wave" (also referred to as "the Osborn wave,""the J deflection," or "the camel's hump") is a distinctive deflection occurring at the QRS-ST junction. In 1953, Dr. John Osborn described the "J wave" as an "injury current" resulting in ventricular fibrillation during experimental hypothermia. Although "J Wave" is supposed to be pathognomonic of hypothermia, it is seen in a host of other conditions such as hypercalcemia, brain injury, subarachnoid hemorrhage, cardiopulmonary arrest from over sedation, the Brugada syndrome, vasospastic angina, and idiopathic ventricular fibrillation. However, there is paucity of literature data as regards to ischemic etiology of "J Wave." In this article, we present a case where "J waves" were probably induced by ischemia. We also discuss the mechanism of ischemia-induced "J wave" accentuation and its prognostic implications.

Cardiac rhabdomyoma in a neonate: application of serial echocardiography.

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.