Heart and Vascular

Kandzari, D. E., M. Bohm, F. Mahfoud, R. R. Townsend, M. A. Weber, S. Pocock, K. Tsioufis, D. Tousoulis, J. W. Choi, C. East, S. Brar, S. A. Cohen, M. Fahy, G. Pilcher and K. Kario (2018). “Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial.” Lancet. 391(10137): 2346-2355. Epub 2018 May 23

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BACKGROUND: Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. METHODS: In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged 20-80 years) were enrolled at 25 centres in the USA, Germany, Japan, UK, Australia, Austria, and Greece. Eligible patients had an office systolic blood pressure of between 150 mm Hg and 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher; a 24 h ambulatory systolic blood pressure of between 140 mm Hg and 170 mm Hg at second screening; and were on one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned to undergo renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were masked to randomisation assignments. The primary efficacy endpoint was blood pressure change from baseline (measured at screening visit two), based on ambulatory blood pressure measurements assessed at 6 months, as compared between treatment groups. Drug surveillance was used to assess medication adherence. The primary analysis was done in the intention-to-treat population. Safety events were assessed through 6 months as per major adverse events. This trial is registered with ClinicalTrials.gov, number NCT02439775, and follow-up is ongoing. FINDINGS: Between July 22, 2015, and June 14, 2017, 467 patients were screened and enrolled. This analysis presents results for the first 80 patients randomly assigned to renal denervation (n=38) and sham control (n=42). Office and 24 h ambulatory blood pressure decreased significantly from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24 h systolic blood pressure -7.0 mm Hg, 95% CI -12.0 to -2.1; p=0.0059, 24 h diastolic blood pressure -4.3 mm Hg, -7.8 to -0.8; p=0.0174, office systolic blood pressure -6.6 mm Hg, -12.4 to -0.9; p=0.0250, and office diastolic blood pressure -4.2 mm Hg, -7.7 to -0.7; p=0.0190). The change in blood pressure was significantly greater at 6 months in the renal denervation group than the sham-control group for office systolic blood pressure (difference -6.8 mm Hg, 95% CI -12.5 to -1.1; p=0.0205), 24 h systolic blood pressure (difference -7.4 mm Hg, -12.5 to -2.3; p=0.0051), office diastolic blood pressure (difference -3.5 mm Hg, -7.0 to -0.0; p=0.0478), and 24 h diastolic blood pressure (difference -4.1 mm Hg, -7.8 to -0.4; p=0.0292). Evaluation of hourly changes in 24 h systolic blood pressure and diastolic blood pressure showed blood pressure reduction throughout 24 h for the renal denervation group. 3 month blood pressure reductions were not significantly different between groups. Medication adherence was about 60% and varied for individual patients throughout the study. No major adverse events were recorded in either group. INTERPRETATION: Renal denervation in the main renal arteries and branches significantly reduced blood pressure compared with sham control with no major safety events. Incomplete medication adherence was common. FUNDING: Medtronic.

Roberts, W. C. (2018). “Quantitative Extent of Atherosclerotic Plaque in the Major Epicardial Coronary Arteries in Patients with Fatal Coronary Heart Disease, in Coronary Endarterectomy Specimens, in Aorta-Coronary Saphenous Venous Conduits, and Means to Prevent the Plaques: A Review after Studying the Coronary Arteries for 50 Years.” Am J Cardiol 121(11): 1413-1435.

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This review tries to answer the following 15 questions: Is atherosclerosis a systemic or a regional disease? Is atherosclerosis in any particular region focal or diffuse? What is the quantity of atherosclerotic plaques in endarterectomy specimens of the right coronary artery in patients undergoing coronary artery bypass grafting (CABG) compared to that in the right coronary artery in patients with fatal coronary artery disease? How do the units used for measuring arterial narrowing by angiography compare to the units used for measuring arterial narrowing at necropsy? What do atherosclerotic plaques consist of in coronary arteries in patients with fatal coronary disease? What is the quantity of atherosclerotic plaque in bypassed -vs- non-bypassed native coronary arteries in patients dying early (<60 days) or late (>60 days) after coronary artery bypass grafting? What is the frequency of acute coronary lesions and multi-luminal channels at necropsy in patients with unstable angina pectoris, sudden coronary death, and acute myocardial infarction? What is the mechanism of luminal widening by angioplasty in the coronary arteries? What observations suggest that atherosclerotic plaques are the result at least in part of organization of thrombi? Is atherosclerosis a multifactoral or a unifactoral disease? What characteristics distinguish carnivores and herbivores? What are reasonable guidelines for whom to treat with lipid-altering agents? What is the rule of 5 and the rule of 7 in statin therapy? What is the effect of lipid lowering drug therapy on coronary luminal narrowing? What are some requisites for a healthy life?

Mack, M. J., A. Vasudevan and M. Hamandi (2018). “TAVR in younger patients with aortic stenosis: anything new?” EuroIntervention 14(1): 29-30.

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Transcatheter aortic valve replacement (TAVR) has been shown to be non-inferior to surgical aortic valve replacement (SAVR) in multiple randomised trials in high- and intermediate-risk patients. Most patients studied in these randomised trials were elderly, being for the most part in their late seventies and early eighties in age. Two trials in lower-risk patients which have recently completed enrolment in the USA presumably include younger patients. However, the results of those trials will not be available until mid 2019. In this issue of EuroIntervention, Eggebrecht and colleagues have attempted to shed some light on the outcomes of TAVR compared with SAVR in younger patients prior to the availability of those trial reports . . . In summary, there is little if any new information obtained in this study that helps to inform clinical practice. The cardiology and cardiac surgery community would be better off waiting for the outcomes of randomised trials in lower-risk and presumably younger patients before changing current practice in younger patients. Despite the efforts of the study investigators, there is nothing new here to inform the clinician. (Excerpts from text, p. 29-30; no abstract available.)

Mack, M., M. Hamandi and A. Gopal (2018). “TAC for TAVR: What Is the Score?” JACC Cardiovasc Imaging. May 11. [Epub ahead of print].

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Commentary on Development of a Risk Score Based on Aortic Calcification to Predict 1-year Mortality After Transcatheter Aortic Valve Replacement, Pierre Lantelme M.D., Ph.D., JACC: Cardiovascular Imaging, published online 16 May 2018.

Kale, P. and A. Afzal (2018). “Stage B Heart Failure: To Strain or Not to Strain.” JACC Cardiovasc Imaging. May 11.[Epub ahead of print].

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Heart failure (HF) has been considered a progressive disorder than can be represented as a clinical continuum. In 2005, American College of Cardiology/American Heart Association updated the guidelines for management of HF and identified 4 states of heart failure with clinical recommendations for each stage. These guidelines helped address some of the confusion stemming from the symptom severity-based New York Heart Association functional classification. Symptom severity can change drastically over a short period either from medical therapy or absence of it, which can create confusion on treatment recommendations based solely on New York Heart Association functional classification. In the current schema, Stage B heart failure (SBHF) includes patients with Stage A HF who have structural heart disease but no current or prior symptoms of HF. It has been estimated that the number of patients in Stage B is about 2 times higher than Stages C and D combined. (Brief excerpt from this commentary, in press; no abstract available.)