Characteristics and Outcomes of Patients With Severe Aortic Stenosis Discussed by the Multidisciplinary "Heart Team" According to Treatment Allocation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an alternative and effective contemporary intervention to surgical aortic valve replacement (SAVR) for patients with severe aortic valve disease at increased surgical risk. Guidelines recommend a multidisciplinary "Heart Team" (MHT) review of patients considered for a TAVI procedure, but this has been little studied. We reviewed the characteristics, treatments and outcomes of such patients reviewed by the MHT at our centre. METHODS: Data on consecutive patients with severe aortic valve stenosis discussed by the Auckland City Hospital MHT from June 2011 to August 2016 were obtained from clinical records. Patient characteristics, treatment and outcomes were analysed using standard statistical methods. RESULTS: Over the 5-year period 243 patients (mean age 80.2 ± 8.0 years, 60% male) were presented at the MHT meeting. TAVI was recommended for 200, SAVR for 26 and medical therapy for 17 patients, with no significant difference in mean age (80.2 ± 8.3, 80.4 ± 6.1, 80.4 ± 7.3 years, respectively) or EuroSCORE II (6.5 ± 4.7%, 5.3 ± 3.6%, 6.7 ± 4.3%, respectively). Over time, there was an increase in the number of patients discussed and treated, with no change in their mean age, but the mean EuroSCORE II significantly decreased (TAVI p = 0.026, SAVR p = 0.004). Survival after TAVI and SAVR was similar to that of the age-matched general population, but superior to medical therapy p = 0.002 (93% (n = 162), 84% (n = 21) and 73% (n = 18) at one year and 85% (n = 149), 84% (n = 21) and 54% (n = 13) at 2 years, respectively). CONCLUSIONS: An increasing number of patients were discussed at the MHT meeting with the majority undergoing TAVI, with a similar age and EuroSCORE II to those allocated SAVR or medical therapy. Survival following TAVI and SAVR was superior to medical therapy and similar to the age-matched general population. These findings suggest that the MHT process is robust, consistent and appropriately allocating a limited treatment resource.

Dynamically scaled phantom phase contrast MRI compared to true-scale computational modeling of coronary artery flow.

PURPOSE: To examine the feasibility of combining computational fluid dynamics (CFD) and dynamically scaled phantom phase-contrast magnetic resonance imaging (PC-MRI) for coronary flow assessment. MATERIALS AND METHODS: Left main coronary bifurcations segmented from computed tomography with bifurcation angles of 33°, 68°, and 117° were scaled-up ∼7× and 3D printed. Steady coronary flow was reproduced in these phantoms using the principle of dynamic similarity to preserve the true-scale Reynolds number, using blood analog fluid and a pump circuit in a 3T MRI scanner. After PC-MRI acquisition, the data were segmented and coregistered to CFD simulations of identical, but true-scale geometries. Velocities at the inlet region were extracted from the PC-MRI to define the CFD inlet boundary condition. RESULTS: The PC-MRI and CFD flow data agreed well, and comparison showed: 1) small velocity magnitude discrepancies (2-8%); 2) with a Spearman's rank correlation ≥0.72; and 3) a velocity vector correlation (including direction) of r(2) ≥ 0.82. The highest agreement was achieved for high velocity regions with discrepancies being located in slow or recirculating zones with low MRI signal-to-noise ratio (SNRv ) in tortuous segments and large bifurcating vessels. CONCLUSION: Characterization of coronary flow using a dynamically scaled PC-MRI phantom flow is feasible and provides higher resolution than current in vivo or true-scale in vitro methods, and may be used to provide boundary conditions for true-scale CFD simulations. J. MAGN. RESON. IMAGING 2016;44:983-992.

How to do it?: percutaneous treatment of a severely stenosed and calcified left main stem bifurcation.

CASE SUMMARY: A 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. INVESTIGATION: Coronary 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. DIAGNOSIS: Acute coronary syndrome with extensive calcific coronary artery disease in the left main stem bifurcation. MANAGEMENT: Sequential rotational atherectomy of the left main stem bifurcation followed by 'Y'-stenting using three Xience Prime drug eluting stents.

Non-contact quantification of aortic stenosis and mitral regurgitation using carotid waveforms from skin displacements.

Objective. Early diagnosis of heart problems is essential for improving patient prognosis.Approach. We created a non-contact imaging system that calculates the vessel-induced deformation of the skin to estimate the carotid artery pressure displacement waveforms. We present a clinical study of the system in patients (n= 27) with no underlying condition, aortic stenosis (AS), or mitral regurgitation (MR).Main results. Displacement waveforms were compared to aortic catheter pressures in the same patients. The morphologies of the pressure and displacement waveforms were found to be similar, and pulse wave analysis metrics, such as our modified reflection indices (RI) and waveform duration proportions, showed no significant differences. Compared with the control group, AS patients displayed a greater proportion of time to peak (p= 0.026 andp= 0.047 for catheter and displacement, respectively), whereas augmentation index (AIx)was greater for the displacement waveform only (p= 0.030). The modified RI for MR (p= 0.047 andp= 0.004 for catheter and displacement, respectively) was lower than in the controls. AS and MR were also significantly different for the proportion of time to peak (p= 0.018 for the catheter measurements), RI (p= 0.045 andp= 0.002 for the catheter and displacement, respectively), and AIx (p= 0.005 for the displacement waveform).Significance. These findings demonstrate the ability of our system to provide insights into cardiac conditions and support further development as a diagnostic/telehealth-based screening tool.

A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial.

BACKGROUND: A fully bioabsorbable drug-eluting coronary stent that scaffolds the vessel wall when needed and then disappears once the acute recoil and constrictive remodelling processes have subsided has theoretical advantages. The bioasorbable everolimus-eluting stent (BVS) has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. We assessed the feasibility and safety of this BVS stent. METHODS: In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3.0 x 12 mm or 3.0 x 18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131. FINDINGS: Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3.3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0.44 (0.35) mm and was mainly due to a mild reduction of the stent area (-11.8%) as measured by intravascular ultrasound. The neointimal area was small (0.30 [SD 0.44] mm2), with a minimal area obstruction of 5.5%. INTERPRETATION: This study shows the feasibility of implantation of the bioabsorbable everolimus-eluting stent, with an acceptable in-stent late loss, minimal intrastent neointimal hyperplasia, and a low stent area obstruction. FUNDING: Abbott Vascular.

Valve-in-Valve in a Flail Bioprosthetic Mitral Valve With Endocarditis Using a Novel Embolic Protection Device.

A 79-year-old woman presented in cardiogenic shock with a flail bioprosthetic mitral valve leaflet and Staphylococcus aureus endocarditis. In the absence of other viable options, transfemoral valve-in-valve transcatheter mitral valve replacement was performed with a novel embolic protection device, resulting in trace mitral regurgitation and no neurologic complications. (Level of Difficulty: Advanced.).

The antiplatelet effect of six non-steroidal anti-inflammatory drugs and their pharmacodynamic interaction with aspirin in healthy volunteers.

Patients with cardiovascular disease taking aspirin and some nonsteroidal anti-inflammatory drugs (NSAIDs) appear to have increased vascular events. This study was conducted to compare the ex vivo antiplatelet effects of 6 commonly used NSAIDs and to determine whether these agents antagonize the effect of aspirin. Platelet function was assessed by Platelet Function Analyzer 100 closure time in normal subjects in a randomized, blinded, multiple-crossover study. Platelet function was measured 12 hours after the administration of each NSAID. The NSAID was then given 2 hours before aspirin 300 mg, and platelet function was reassessed 24 hours later. At 12 hours after the administration of naproxen and tiaprofenic acid, closure time was significantly prolonged, whereas the other NSAIDs did not cause significant prolongations. Compared with placebo plus aspirin, closure time was significantly reduced when ibuprofen, indomethacin, naproxen, or tiaprofenic acid was given before aspirin. In conclusion, ibuprofen, indomethacin, naproxen, and tiaprofenic acid all block the antiplatelet effect of aspirin. Sulindac and celecoxib did not demonstrate any significant antiplatelet effect or reduce the antiplatelet of aspirin and, therefore, of the NSAIDs evaluated may be the drugs of choice for patients requiring aspirin and NSAIDs.

Coronary artery perforation successfully treated with tris-acryl gelatin microsphere embolisation.

We describe a case of coronary artery perforation in a 76-year-old man, successfully treated by tris-acryl gelatin microsphere embolisation. This novel interventional embolic material is used in interventional radiology for arterial embolisation. We believe that this is the first report of its use for a coronary artery perforation.

Percutaneous closure of post-myocardial infarction ventricular septal defects: a single centre experience.

BACKGROUND: Ventricular septal defect (VSD) is a serious complication of myocardial infarction (MI), occurring in about 0.2% of cases. Untreated, mortality in high and early surgical repair is difficult because of friable necrotic tissue. Percutaneous closure may be an alternative treatment option in selected patients. METHODS: We report our complete single centre experience of percutaneous post-MI VSD closure using the Amplatzer device. The VSD was closed under general anaesthesia with fluoroscopic and transoesophageal echocardiographic guidance. Clinical characteristics and outcomes are reported. RESULTS: The five patients were aged from 66 to 76 years. Closure was attempted from 1 to 64 days post-MI. VSD closure was performed in two patients after surgical patch dehiscence (infero-apical and infero-basal VSDs). The procedure was successful in four patients, with failure to cross the interventricular septum in one. Thirty-day and 12-month survival was 3/5 (60%); no patient undergoing VSD closure early post-MI survived, whereas 3/3 in whom the procedure was undertaken >14 days post-MI survived, suggesting that it may be appropriate to delay attempts at percutaneous VSD closure after MI. CONCLUSION: Percutaneous VSD closure post-MI appears to be a viable alternative to surgical repair, with favourable outcomes if it can be undertaken >14 days post-infarct.

Postdischarge outcome after Takotsubo syndrome compared with patients post-ACS and those without prior CVD: ANZACS-QI 19.

Objective: Takotsubo syndrome (TS) mimics acute coronary syndrome (ACS) but has a distinct pathophysiology. While in-hospital adverse outcomes appear similar to those presenting with an ACS, data on longer term postdischarge risk are conflicting. This study sought to assess the long-term prognosis of patients discharged alive after TS. Methods: The clinical profile and in-hospital and long-term outcomes were prospectively assessed in consecutive patients with TS. Survival in patients with TS was compared with two representative age-matched and gender-matched comparison cohorts: a hospitalised ACS cohort and a community cohort without known cardiovascular disease (CVD). Results: Two hundred and-twenty-five patients with TS (216 women, mean age 63.7±11.8 years) were included. In-hospital mortality was 1.8% and 1.9% for patients with TS and ACS, respectively. Of the 219 patients with TS with postdischarge follow-up, at a mean follow-up of 4.8±3.2 years, there were 19 (8.3%) deaths, 18 of which were from non-cardiac causes. When compared with the cohort without prior CVD, postdischarge patients with TS were at increased mortality risk (HR 2.00, 95% CI 1.26 to 3.17, p=0.003), but mortality in postdischarge patients with ACS was over threefold higher (HR 3.43, 95% CI 2.97 to 3.96, p<0.0001). Conclusions: In-hospital mortality for patients diagnosed with TS and ACS was similar. However, while postdischarge survivors of TS had a long-term survival which was poorer than for a community-based cohort without known CVD, their survival was better than for postdischarge survivors of an ACS event. Late deaths in patients with TS were almost all from non-cardiac causes.

Bench testing and coronary artery bifurcations: a consensus document from the European Bifurcation Club.

This is a consensus document from the European Bifurcation Club concerning bench testing in coronary artery bifurcations. It is intended to provide guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where the United States Food and Drug Administration (FDA) or International Organization for Standardization (ISO) guidelines are limited or absent. These recommendations provide guidelines rather than a step-by-step manual. We provide data on the anatomy of bifurcations and elastic response of coronary arteries to aid model construction. We discuss testing apparatus, bench testing endpoints and bifurcation nomenclature.

Long and short of optimal stent design.

The ideal stent must fulfil a broad range of technical requirements. Stents must be securely crimped onto the delivery balloon and, in this form, must have a low profile and be sufficiently flexible to facilitate deliverability to the lesion site without distortion or displacement. Following expansion, stents must exert sufficient radial force on the vessel wall to overcome lesion resistance and elastic recoil. To achieve an optimal lumen diameter, the lesion must be uniformly and adequately scaffolded, with minimal tissue prolapse between struts but without compromising side-branch access. Furthermore, the deployed stent must conform to the vessel curvature to minimise vessel distortion, particularly at the stent edges. Radio-opacity is also important to guide safe positioning, adequate deployment and postdilataion and to permit assessment of optimal stent expansion. Equally though, the stent lumen must also be sufficiently visible to allow radiographic assessment of flow dynamics and restenosis. Efforts to optimise one characteristic of stent design may have detrimental effects on another. Thus, currently available stents all reflect a compromise between competing desirable features and have subtle differences in their performance characteristics. Striving to achieve stents with optimal deliverability, conformability and radial strength led to a reduction in longitudinal strength. The importance of this parameter was highlighted by complications occurring in the real-world setting where percutaneous coronary intervention is often undertaken in challenging anatomy. This review focuses on aspects of stent design relevant to longitudinal strength.

Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension.

BACKGROUND AND AIMS: Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and performance of the second generation EnligHTN™ Renal Denervation System. METHODS: This first-in-human, prospective, multi-center, non-randomized study included 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mmHg) with drug-resistant hypertension. The primary safety and performance objectives were to characterize, from baseline to 6 months post procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure. RESULTS: Renal artery denervation, using the second generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, 6, 12, 18 and 24 months by 19/7, 26/9, 25/7, 23/7, 25/8 and 27/9 mmHg, respectively (p ≤ 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through 24 months of follow-up. CONCLUSIONS: Renal sympathetic denervation using the second generation EnligHTN Renal Denervation System resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 24 months. Future studies will need to address the utility of this system against an appropriate sham based comparator.