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.

Mitral atresia with transposed great arteries and normal semilunar valves: a rare combination.

Mitral atresia is commonly seen as a part of the spectrum of hypoplastic left heart syndrome, and it is usually associated with multiple levels of systemic outflow tract obstruction. Isolated mitral atresia with a normal aortic valve is extremely rare. We report the rare combination of mitral atresia, transposition of the great arteries, and unobstructed systemic and pulmonary blood flow.

Clinical profile and one-year outcomes of patients with mural infective endocarditis: - A tertiary care centre study based on data from a seven-year registry.

BACKGROUND: Infective endocarditis patients present very rarely with vegetations on the mural endocardium. Only very few studies are available comparing Mural infective endocarditis with commoner valvular or device related infective endocarditis. AIM: To analyse the clinical features, microbiological profile and clinical course of mural endocarditis in comparison to valvular endocarditis. METHODS: This was a retrospective analysis of data from a registry of infective endocarditis. Patients enrolled between April 2012 and April 2019 were included. Patients who were reported to have vegetations on the mural endocardial surface were taken as a group and compared with rest of the patients. Clinical profile, laboratory parameters including culture and outcomes were compared between the two groups. RESULTS: Out of 278 patients in the study, 15 (5.38%) had vegetations on the mural endocardium. Of them, only 4 patients had structural heart diseases. All the patients with mural endocarditis were NYHA class II or below at presentation. Ventricles were the commonest sites of vegetations. Inflammatory markers like ESR and CRP were low in mural endocarditis compared to rest. Culture positivity was high in mural endocarditis and Staphylococcus Aureus was the commonest organism. Mural endocarditis patients had similar in hospital mortality to rest of the patients. Cardiac complications were not reported in mural endocarditis, but they had similar incidence of embolic complications including neurological events. CONCLUSION: Mural endocarditis is a rare clinical entity with similar morbidity and mortality to that of endocarditis with valvular vegetation.

30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study.

OBJECTIVES: This study sought to evaluate the 30-day and 1-year 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 is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. METHODS: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. CONCLUSIONS: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).

Baseline C-reactive protein levels and prognosis in patients with infective endocarditis: A prospective cohort study.

BACKGROUND: Early diagnosis and risk-stratification among infective endocarditis (IE) patients are limited by poor microbiological yield and inadequate characterization of vegetations. A simple tool that can predict adverse outcomes in the early phase of management is required. AIM: To study the prognostic value of C-reactive protein (CRP) levels at admission and its role in predicting various clinical outcomes. METHODS: In a prospective study of consecutive IE patients diagnosed by modified Duke's criteria, we measured the peak levels of CRP and erythrocyte sedimentation rate (ESR) in the first 3 days of admission and correlated it with in-hospital mortality, six-month mortality, embolic phenomena and the need for urgent surgery. Predefined laboratory-microbiological sampling protocols and antibiotic-initiation protocols were followed. Receiver-operating-characteristics curves were generated to identify a reliable cut-off for CRP in predicting various outcomes. RESULTS: Out of 101 patients who were treated, 85 patients had 'definite' IE. Blood cultures were positive in 55% (n = 39); and Staphylococcus species was the most common organism. Major complications occurred in 74.1% (n = 63) and in-hospital mortality was 32.9% (n = 28). Mean ESR and CRP levels were 102 ±â€¯31 mm/h and 51 ±â€¯20 mg/l, respectively. In multivariable analysis, high CRP levels were independently predictive of mortality, major complications, embolic events and need for urgent surgery. A CRP >40 mg/l predicted adverse outcomes with a sensitivity of 73% and specificity of 99%. CONCLUSION: The study shows that baseline CRP level in the first 3 days of admission is a strong predictor of short term adverse outcomes in IE patients, and a useful marker for early risk stratification.

An unusual cause of acute cor pulmonale--significance of the 'continuous diaphragm sign'.

A patient presented with chest pain and clinical features of acute right heart failure. Initial work up revealed the presence of severe PAH. Acute pulmonary embolism is the commonest and most life-threatening cause for acute cor pulmonale. Even though the clinical picture suggested pulmonary embolism, a subtle sign was missed from the first chest X-ray taken in the emergency department. However on reanalysis the 'continuous diaphragm sign' later guided us towards the diagnosis. Our case represents one of the first reports of a rare etiology for acute cor pulmonale--hypersensitivity pneumonitis. Right ventricular dysfunction was caused by an acute rise in pulmonary artery pressures as well as by the compressive effects of pneumomediastinum. We emphasize the role played by a good quality chest X-ray early in the management of acute chest pain syndromes. However pulmonary embolism should be ruled out conclusively before redirecting attention to less malignant conditions.

A change in QRS morphology in right ventricular apical pacing: is it a red flag sign?

A 74-year-old man with symptomatic complete heart block underwent right ventricular apical permanent pacemaker implantation. The postoperative ECG showed, as expected, completely paced left bundle branch block QRS morphology. However, at the 2-month follow-up examination, his ECG showed paced right bundle branch block (RBBB) QRS morphology, although the patient was asymptomatic. On evaluation, pacemaker functioning was normal with no evidence of lead displacement. This case report highlights that RBBB morphology of paced QRS complex is not always a red flag sign.

Relevance of latent TB infection in areas of high TB prevalence.

About one-third of the world population has latent TB infection (LTBI), the majority of which is distributed in 22 high-burden countries. Early diagnosis and treatment of active TB remains the top priority in resource-poor countries with high TB prevalence. Notwithstanding, because LTBI contributes significantly to the pool of active TB cases later on, its diagnosis and treatment is essential, especially in high-risk groups. The lack of a gold standard and several limitations of currently available tools, namely the tuberculin skin test and interferon-γ release assays, are major constraints for LTBI diagnosis. In areas with high TB prevalence, interferon-γ release assays have not shown superiority over the conventional tuberculin skin test and are yet to be systematically studied. Decisions regarding LTBI treatment with isoniazid preventive therapy should be made, keeping in mind the high prevalence of isoniazid resistance in these settings. Although efforts to shorten the LTBI treatment duration are encouraging, most trials have focused on adherence and toxicity. Future trials on short-duration regimens in high-burden settings should address drug efficacy issues as well. LTBI management, therefore, should comprise a targeted screening approach and individualization of LTBI treatment protocols. In addition, efforts should focus on airborne infection control measures in high-burden countries. A high prevalence of drug-resistant TB, the HIV epidemic, and delays in the diagnosis of active TB cases are other major concerns in areas of high TB prevalence. There is ample space for further research in these countries, whose outcomes may strengthen future national guidelines.

Radiation accident at Mayapuri scrap market, Delhi, 2010.

This article reports the accidental public radiation exposure in a scrap market in Delhi, India, on March 2010. The source, a gamma unit containing Cobalt-60 pencils, was improperly disposed of by a research institution in violation of national regulations for radiation protection and safety of radioactive sources. The unit was sold off to unsuspecting scrap dealers who dismantled the equipment. This event subsequently caused the most severe radiation accident reported in India to date, resulting in seven radiation injuries and one death. The clinical course of five of the patients treated at the All India Institute of Medical Sciences hospital, New Delhi, is summarised in this report. All five patients suffered from the haematological form of the acute radiation syndrome and local cutaneous radiation injury as well. While four patients exposed to doses between 0.6 and 2.8 Gy survived with intensive or supportive treatment, the patient with the highest exposure of 3.1 Gy died due to acute respiratory distress syndrome and multi-organ failure on Day 16 after hospitalisation. The incident highlights the current gaps in the knowledge, infrastructure and legislation in handling radioactive materials. Medical institutions need to formulate individualised triage and management guidelines to immediately respond to future public radiological accidents.