Timothy Watson

Renal denervation for resistant hypertension using an irrigated radiofrequency balloon: 12-month results from the Renal Hypertension Ablation System (RHAS) trial

AIMSnRenal denervation using the point-by-point application of radiofrequency energy delivered by the first-generation Symplicity system is effective in lowering office blood pressure but may be time-consuming. The OneShot Renal Denervation System with a balloon-mounted spiral electrode potentially shortens and simplifies the procedure. This study is a hypothesis-generating first-in-human study to assess feasibility, and to provide preliminary efficacy and safety data.nnnMETHODS AND RESULTSnEligible patients had a baseline office systolic blood pressure ≥160 mmHg (or ≥150 mmHg for diabetics) and were on two or more antihypertensive medications. Nine patients were enrolled. The primary endpoint, the insertion of the OneShot balloon into each renal artery and the delivery of radiofrequency energy, was achieved in 8/9 (89%) of patients. The one failure (the first patient) was due to generator high-impedance safety shut-off threshold set too low for humans. Adverse events were minor. No patient developed renal artery stenosis. Baseline BP was 185.67 ± 18.7 mmHg and the reductions at 1, 3, 6 and 12 months were 30.1 ± 13.6 (p=0.0004), 34.2 ± 20.2 (p=0.002), 33.6 ± 32.2 (p=0.021) and 30.6 ± 22.0 (p=0.019).nnnCONCLUSIONSnThe OneShot renal denervation system successfully delivered radiofrequency energy to the renal arteries in a short and straightforward procedure. Australian New Zealand Clinical Trials Registry - URL: anzctr.org.au. Trial identification: ACTRN12611000987965.

First-in-human use of the OneShot™ renal denervation system from Covidien

Percutaneous transcatheter renal sympathetic denervation (RDN) is a promising treatment for refractory hypertension (HT). RDN was found in one series of clinical studies to reduce systolic blood pressure (SBP) by as much as a mean of 30 mmHg with 85% of subjects experiencing sustained reductions of 10 mm or more out to two years after RDN. This degree of blood pressure reduction may reduce stroke and myocardial infarction rates and is anticipated to translate into improved life expectancy. The lowering of blood pressure by RDN has been shown to improve glycaemic control and reverse left ventricular hypertrophy. Beneficial effects on renal function, sleep apnoea and heart failure are suggested as well. This report describes the first patient treated using the OneShot™ Renal Denervation System (formerly Maya Medical now Covidien, Campbell, CA, USA).

First-in-human experience using the Volcano VIBE-RX vascular imaging balloon catheter system (Volcano IVUS-guided Balloon Evaluation - New Zealand: VIBE-NZ Study)

AIMSnIntravascular ultrasound (IVUS) is a proven and safe imaging modality used to guide percutaneous coronary intervention (PCI). The Volcano VIBE™ RX Vascular Imaging Balloon Catheter is a novel rapid exchange, 0.014 wire-compatible multi-lumen conventional balloon catheter modified with the addition of an IVUS transducer proximal to the balloon, delivered via a standard 6 Fr sheath. We sought to evaluate the safety, balloon performance, and image quality of the VIBE™ RX in patients scheduled for coronary intervention.nnnMETHODS AND RESULTSnPatients aged >21 and <85 years with single or multivessel coronary disease scheduled for PCI due to coronary ischaemic symptoms were included. Those with angiographic features that precluded the safe or informative use of the device were excluded. Twenty-nine patients having angiography because of ischaemic symptoms underwent 44 VIBE RX imaging runs, with balloon dilation in 20. Successful device deployment was achieved in all but one patient. All images were adequate and reproducible. One patient had a non-ST-elevation MI felt to be due to the complexity of the procedure rather than directly related to the VIBE™ RX.nnnCONCLUSIONSnThe study demonstrated the safety and effectiveness of the VIBE™ RX for its intended purpose with minimal failure rate and no directly related complications.

How to Do It?: Percutaneous Treatment of a Severely Stenosed and Calcified Left Main Stem Bifurcation

CASE SUMMARYnA frail 87 year-old lady presented with rest angina associated with widespread ECG change and troponin release. She failed attempts at medical therapy and therefore was referred for coronary intervention on the basis that she was not a surgical candidate.nnnINVESTIGATIONnCoronary angiography demonstrated heavily calcified coronary arteries with critical disease at the distal left main stem bifurcation extending into the proximal segments of both LAD and circumflex.nnnDIAGNOSISnAcute coronary syndrome with extensive calcific coronary artery disease in the left main stem bifurcation.nnnMANAGEMENTnSequential rotational atherectomy of the left main stem bifurcation followed by Y-stenting using three Xience Prime drug eluting stents.