Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: The EnligHTN I trial

Aims: Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN™ multi-electrode system. Methods and results: We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN™ system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by −28/10, −27/10 and −26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Conclusion: Renal sympathetic denervation, using the EnligHTN™ multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN™ system delivers a promising therapy for the treatment of drug-resistant hypertension.Stephen G. Worthley, Costas P. Tsioufis, Matthew I. Worthley, Ajay Sinhal, Derek P. Chew, Ian T. Meredith, Yuvi Malaiapan, and Vasilios Papademetrio

Quantitative assessment of paravalvular regurgitation following transcatheter aortic valve replacement

Paravalvular aortic regurgitation (PAR) following transcatheter aortic valve implantation (TAVI) is well acknowledged. Despite improvements, echocardiographic measurement of PAR largely remains qualitative. Cardiovascular magnetic resonance (CMR) directly quantifies AR with accuracy and reproducibility. We compared CMR and transthoracic echocardiography (TTE) analysis of pre-operative and post-operative aortic regurgitation in patients undergoing both TAVI and surgical aortic valve replacement (AVR).Gareth Crouch, Phillip J Tully, Jayme Bennetts, Ajay Sinhal, Craig Bradbrook, Amy L Penhall, Carmine G De Pasquale, Robert A Baker, and Joseph B Selvanayaga

Changes of left ventricular mechanics after trans-catheter aortic valve implantation and surgical aortic valve replacement for severe aortic stenosis: A tissue-tracking cardiac magnetic resonance study

Background: Left ventricular (LV) mechanics are impaired in patients with severe aortic stenosis (AS). The aim of the present study was to assess their changes early and late after trans-catheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) using cardiac magnetic resonance (CMR) tissue-tracking imaging. Methods: In 59 patients with severe AS undergoing either TAVI (n = 35) or surgical AVR (n = 24), CMR with late gadolinium enhancement (LGE) imaging was performed before and early post-procedure to evaluate LV function and mass, and presence/extent of LGE. A third CMR scan was performed in 29 patients after a mean follow-up of 15 ± 4 months. Tissue-tracking analysis was applied to cine CMR images, to assess LV global longitudinal (GLS), circumferential (GCS) and radial (GRS) strains.&#13; Results: The TAVI and surgical AVR groups were similar with respect to baseline (p = 0.14) and early post-procedure (p = 0.16) LV ejection fraction. However, baseline LV GLS was significantly impaired in TAVI patients compared to surgical AVR patients (p = 0.025). Early post-procedure, TAVI resulted in a significant improvement of LV GLS (p = 0.003), while a significant worsening of LV GLS was observed early after surgical AVR (p = 0.012). At longer term follow-up, both TAVI and surgical AVR groups experienced a significant reduction of LV mass and a significant improvement of LV myocardial mechanics in all the three directions. Conclusions: Treatment-specific differences in the changes of LV myocardial mechanics early after afterload release by TAVI and surgical AVR are present. Later, both interventions are associated with an improvement of LV myocardial deformation, alongside a regression of LV hypertrophy

Air Trapping on Chest CT Is Associated with Worse Ventilation Distribution in Infants with Cystic Fibrosis Diagnosed following Newborn Screening

BACKGROUND: In school-aged children with cystic fibrosis (CF) structural lung damage assessed using chest CT is associated with abnormal ventilation distribution. The primary objective of this analysis was to determine the relationships between ventilation distribution outcomes and the presence and extent of structural damage as assessed by chest CT in infants and young children with CF. METHODS: Data of infants and young children with CF diagnosed following newborn screening consecutively reviewed between August 2005 and December 2009 were analysed. Ventilation distribution (lung clearance index and the first and second moment ratios [LCI, M(1)/M(0) and M(2)/M(0), respectively]), chest CT and airway pathology from bronchoalveolar lavage were determined at diagnosis and then annually. The chest CT scans were evaluated for the presence or absence of bronchiectasis and air trapping. RESULTS: Matched lung function, chest CT and pathology outcomes were available in 49 infants (31 male) with bronchiectasis and air trapping present in 13 (27%) and 24 (49%) infants, respectively. The presence of bronchiectasis or air trapping was associated with increased M(2)/M(0) but not LCI or M(1)/M(0). There was a weak, but statistically significant association between the extent of air trapping and all ventilation distribution outcomes. CONCLUSION: These findings suggest that in early CF lung disease there are weak associations between ventilation distribution and lung damage from chest CT. These finding are in contrast to those reported in older children. These findings suggest that assessments of LCI could not be used to replace a chest CT scan for the assessment of structural lung disease in the first two years of life. Further research in which both MBW and chest CT outcomes are obtained is required to assess the role of ventilation distribution in tracking the progression of lung damage in infants with CF

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium†

To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health

Quantitative assessment of paravalvular regurgitation following transcatheter aortic valve replacement

Paravalvular aortic regurgitation (PAR) following transcatheter aortic valve implantation (TAVI) is well acknowledged. Despite improvements, echocardiographic measurement of PAR largely remains qualitative. Cardiovascular magnetic resonance (CMR) directly quantifies AR with accuracy and reproducibility. We compared CMR and transthoracic echocardiography (TTE) analysis of pre-operative and post-operative aortic regurgitation in patients undergoing both TAVI and surgical aortic valve replacement (AVR).Gareth Crouch, Phillip J Tully, Jayme Bennetts, Ajay Sinhal, Craig Bradbrook, Amy L Penhall, Carmine G De Pasquale, Robert A Baker, and Joseph B Selvanayaga

Anterior-apical mesh repair system in an ambulatory setting

Aim: To examine use of Anterior -Apical mesh repair system for anterior prolapse ≥stage3 in an ambulatory setting.\ud \ud Methods: This is a prospective case series of 111 women at our centre, who underwent an anterior and apical repair with mesh (graft augmented repair) over a consecutive 24 month period.\ud \ud Results: We found a high objective (68.5%) and subjective (87.6%) success rate, with a mesh extrusion rate of only 3.8%. Most cases could be done in a day surgery setting (93.4%). \ud \ud Conclusion: Anterior-Apical mesh repair system has the potential to be used in an ambulatory day surgery setting as demonstrated in our study