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.

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.).

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.

High-sensitivity troponin level pre-catheterization predicts adverse cardiovascular outcomes after primary angioplasty for ST-elevation myocardial infarction.

BACKGROUND: Cardiac troponins are the preferred biomarkers for diagnosing myocardial infarction (MI). High-sensitivity troponin T (hs-TnT) assays have increased sensitivity and enable more rapid diagnosis of infarction. We assessed the prognostic utility of admission hs-TnT to detect outcomes after primary angioplasty for ST-elevation/new left bundle branch block myocardial infarction (STEMI). METHODS: Patients admitted to Auckland City Hospital for acute coronary catheterization with a diagnosis of STEMI between October 2010 and September 2011 were identified, and included if hs-TnT levels were measured at admission. Clinical characteristics and major adverse cardiovascular events (MACE: death, myocardial infarction and revascularization) at 30 days and 1 year were collected from national statistics and electronic medical records. RESULTS: Median admission hs-TnT level in the 173 STEMI patients studied was 59 ng/L (interquartile range (IQR) 19-310). Incidences of MACE at 30 days and 1 year were 10% (n=17) and 18% (n=31), respectively. C-statistics and 95% confidence interval (CI) (95% CI) for hs-TnT on admission at detecting MACE at 30 days and 1 year were 0.800 (0.696-0.904) and 0.750 (0.655-0.845) respectively, with the optimal cut-point of 225 ng/L giving sensitivities/specificities of 76.5%/75.6% and 64.5%/78.2% respectively. Admission log(hs-TnT) independently predicted both MACE at 30 days with hazards ratio 5.16, 95% CI (2.25-11.9) and 1 year with hazards ratio 2.88, 95% CI (1.79-4.63), as did age and cardiogenic shock. Age, Maori or Pacific ethnicity and chronic respiratory disease were independent predictors of hs-TnT>225 ng/L. CONCLUSION: Admission hs-TnT measured in primary angioplasty is strongly prognostic of MACE at 30 days and 1 year, even following adjustment for potential confounding variables.

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.

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

AIMS: Renal 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. METHODS AND RESULTS: Eligible 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). CONCLUSIONS: The 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).

AIMS: Intravascular 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. METHODS AND RESULTS: Patients 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. CONCLUSIONS: The study demonstrated the safety and effectiveness of the VIBE™ RX for its intended purpose with minimal failure rate and no directly related complications.

Serial Doppler echocardiography and tissue Doppler imaging in the detection of elevated directly measured left atrial pressure in ambulant subjects with chronic heart failure.

OBJECTIVES: This study sought to determine the accuracy of Doppler echocardiography and tissue Doppler imaging (TDI) measurements in detecting elevated left atrial pressure (LAP) in ambulant subjects with chronic heart failure using directly measured LAP as the reference. BACKGROUND: Echocardiographic indexes including the ratio of transmitral to annular early diastolic velocities (E/e') may identify raised invasively measured left ventricular filling pressures when tested in cross-sectional studies in some populations. The accuracy of these indexes when measured sequentially remains untested. We determined the accuracy of Doppler echocardiography and TDI measurements in detecting elevated directly measured LAP in ambulant subjects with stable chronic heart failure. METHODS: Fifteen patients with New York Heart Association functional class II to III heart failure and a permanently implanted direct LAP monitoring device underwent serial echocardiography. Simultaneous resting mean LAP, Doppler mitral inflow, mitral annular TDI, and pulmonary venous inflow velocities were obtained on each occasion. Receiver-operator characteristic curve analysis was used to compare the accuracy of the Doppler variables to detect an elevated device LAP ≥15 and ≥20 mm Hg. RESULTS: The patients (13 men, mean age: 71 years, mean left ventricular ejection fraction: 32 ± 12%) underwent 60 simultaneous echocardiographic studies and LAP measurements with a median of 4 (1 to 7) studies per patient. Mean LAP was 16.9 (range 5 to 39 mm Hg) at echocardiography (n = 60). E/e' had the greatest accuracy for detection of LAP ≥15 mm Hg with an area beneath the receiver-operator characteristic curve >0.9. In comparison, area under the curve for mitral E velocity and mitral E/A were 0.77 and 0.76, respectively (p < 0.008 vs. E/e' medial and average). CONCLUSIONS: Single and serial measurements of mitral inflow and mitral annular TDI velocities (E/e') can reliably detect raised directly measured LAP in ambulant subjects with compensated chronic heart failure. (Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients [HOMEOSTASIS]; NCT00547729).

Feasibility, safety, and efficacy of a novel polymeric pimecrolimus-eluting stent: traditional pre-clinical safety end points failed to predict 6-month clinical angiographic results.

OBJECTIVES: The aim of this study was to determine the safety and efficacy of a novel pimecrolimus-eluting stent in a porcine coronary model and in a phase I clinical trial. BACKGROUND: Rapamycin- and paclitaxel-eluting stents reduce the need for repeat intervention by limiting neointimal hyperplasia but might cause delayed healing, pre-disposing patients to late stent thrombosis. Because inflammation plays a key role in restenosis, pimecrolimus, an anti-inflammatory drug, might reduce restenosis without adversely affecting re-endothelialization. METHODS: We evaluated a novel polymeric pimecrolimus-eluting stent covered with a thin parylene C diffusion barrier in a porcine coronary model and in a phase I human clinical trial. The clinical study was a prospective, nonrandomized, first-in-human hypothesis-generating study that enrolled 15 patients who had a single de novo native coronary stenosis. RESULTS: At 28 days and 3 months in the porcine model, histopathologic indicators predicted safety and biocompatibility when stents coated with polymer only, drug only, and 2 drug-polymer formulations were compared with bare-metal stents (BMS). In the phase I clinical trial, 15 patients had successful implantation of pimecrolimus-eluting stents. By 6 months, no patient suffered death, myocardial infarction, or stent thrombosis. However, the angiographic restenosis (61%), mean late loss (1.44 mm), and repeat target lesion revascularization (53%) were significantly higher than historical BMS controls. Whereas the primary end point was percent volume obstruction, restenosis was so severe that operators performed intravascular ultrasound examination in only 6 patients. CONCLUSIONS: Pimecrolimus-eluting stents induced an exaggerated neointimal hyperplasia at 6 months in comparison with historical controls.

Very late changes in the dilated lesion following coronary balloon angioplasty: a 17 year serial quantitative angiographic study.

AIMS: Limited data are available on the changes that occur at the dilated site many years after coronary balloon angioplasty. The development of bioabsorbable stents may increase the importance of understanding the long term changes that occur in an unscaffolded coronary artery following balloon-mediated injury. METHODS AND RESULTS: This study evaluated, by serial quantitative angiography, the natural history of changes that occurred in the dilated segment between early (mean seven months), late (mean 4.5 years) and very late (mean 17 years) follow-up after balloon angioplasty. Of 127 consecutive patients (174 lesions) with successful coronary angioplasty, 125 underwent early, 84 late and 47 very late angiographic follow-up (75% of eligible survivors). The mean lesion diameter stenosis decreased from 36+/-11% at early to 26+/-15% at late follow-up (p<0.0001), and then increased again to 35+/-25% by very late follow-up (p=0.003). Although stenosis severity at early follow-up angiography predicted lesion regression at late follow-up, there was no significant correlation between late and very late follow-up lesion severity. CONCLUSIONS: After coronary angioplasty, lesion regression at the dilated site from 7 months to 4.5 years is followed by slow lesion progression over the next 12 years.

Extraction of challenging intracoronary thrombi: multi-device strategies using guide catheters, distal vascular protection devices and aspiration catheters.

Patients with large intracoronary thrombi represent a difficult management problem for the interventional cardiologist. We report 10 cases of challenging thrombi treated percutaneously using varying combinations of deep guide catheter engagement, guide aspiration, dedicated catheter aspiration and withdrawal of a distal filter vascular protection device. These cases demonstrate interventional options which may be considered for such patients.

The "crush" technique for coronary artery bifurcation stenting: insights from micro-computed tomographic imaging of bench deployments.

OBJECTIVES: This study provides insights into "crush" coronary bifurcation stenting through imaging of bench deployments. BACKGROUND: Although the strategy of provisional side-branch stenting is widely accepted for suitable bifurcation lesions, there is no consensus on the best option for elective stenting with 2 stents. The crush technique has the potential to scaffold and apply the drug to the side-branch ostium where restenosis is most common. METHODS: Sequential steps of crush stent deployment and post-dilation were undertaken in silicone phantoms and recorded on cine angiography and microcomputed tomography. We assessed the effect of deployment strategies, post-dilation strategies, and cell size on side-branch ostial area. RESULTS: Side-branch ostial coverage by metal struts was 53% (95% confidence interval [CI]: 46 to 59) after 1-step kissing post-dilation and was reduced by 2-step kissing post-dilation to 33% (95% CI: 28 to 37; p < 0.0001). Although the residual stenosis after the classical crush strategy was 47% (95% CI: 39 to 53), it was 36% (95% CI: 31 to 40; p = 0.002) after mini-crush deployment. Stents with larger cell size (>3.5 mm diameter) had a residual stenosis of 37% (95% CI: 32 to 42) after crush deployment that was less than the residual stenosis for stents with smaller cell size (52%; 95% CI: 44 to 60; p < 0.0001). CONCLUSIONS: Side-branch ostial stenosis after crush stenting was minimized by mini-crush deployment, 2-step kissing post-dilation, and the use of stents with larger cell size. It is unknown if optimizing stent deployment at bifurcation lesions will reduce clinical stent thrombosis and restenosis.

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.

Distal embolization during native vessel and vein graft coronary intervention with a vascular protection device: predictors of high-risk lesions.

OBJECTIVE: We sought to define clinical and angiographic variables that may predict patients and lesions at increased risk for distal embolism during percutaneous intervention (PCI), as assessed by debris retrieval from a distal-protection filter device. BACKGROUND: Distal thrombo- and atheroembolism may contribute to periprocedural myocardial necrosis during PCI, which may in turn affect long-term outcomes. Distal protection devices have been used to reduce this occurrence with variable outcomes depending on lesion and patient subsets. METHODS: 194 consecutive patients in whom the FilterWire(R) device (FW) [Boston Scientific Corp., Natick, MA] was used for native coronary vessel (n =129) or vein graft (n = 65) PCI were studied. FW debris was visually analyzed using a semi-quantitative grading score. Patients with "significant" debris (particles > or = 1 mm diameter) were compared with those with "nonsignificant" debris (no debris or particles <1 mm) with respect to clinical (age, gender, coronary disease risk factors, clinical presentation, periprocedural medications), and angiographic (vessel treated, vessel size, lesion length, lesion characteristics, angiographic thrombus and TIMI flow before and after PCI) variables. RESULTS: Significant debris was retrieved in 55% of patients, more frequently from vein graft (69%) than native vessel lesions (48%, p = 0.006). No clinical characteristics predicted significant debris retrieval. Angiographic predictors of significant debris by multivariate analysis were longer stent length and final TIMI flow <3 (p = 0.009 and 0.007, respectively). CONCLUSION: Longer stent length, likely reflecting increased lesion length and plaque burden, predicted significant distal embolism during PCI in native vessel and vein graft lesions, as assessed by debris collected in a distal vascular protection device. This suggests that use of vascular protection devices should be considered during PCI of long lesions.

Ultrasound-guided venous access for permanent pacemaker leads.

BACKGROUND: Existing methods of venous access for permanent pacemaker leads have disadvantages. We documented learning times for ultrasound-guided lead implantation and compared them with cephalic venotomy technique. METHODS: Two implanters learnt ultrasound-guided technique by implanting consecutive pacemaker patients. When procedural times stabilized, we reverted to our normal cephalic approach. We measured lead placement time and screening time from skin incision until all leads were placed in superior vena cava were measured. RESULTS: Initial strategy adopted was ultrasound for 60, then cephalic for 38 patients. There were no significant differences between groups in baseline characteristics or number of leads implanted. Lead placement and screening times were significantly shorter for ultrasound, despite inclusion of all learning cases. There was a high success rate for both strategies (88% ultrasound, 87% cephalic). There was significantly greater use of pressure dressings with ultrasound, but no difference in pocket hematoma or pneumothorax. There was a trend for more predictable lead implant times with ultrasound and fluoroscopy times were shorter and more predictable. Independent predictors of lead placement time were body mass index, operator, initial strategy (ultrasound vs cephalic), and procedure number. CONCLUSION: Ultrasound-guided venepuncture for placement of permanent pacing leads is quick to learn and achieves faster lead placement times with shorter and more predictable fluoroscopy time when compared with the cephalic venotomy technique.

Effectiveness of manual pressure hemostasis following transfemoral coronary angiography in patients on therapeutic warfarin anticoagulation.

We evaluated the effectiveness of manual pressure hemostasis after transfemoral coronary angiography in patients on therapeutic warfarin anticoagulation (international normalized ratio [INR] 2.0 to 3.0) compared with discontinuing warfarin > or =48 hours before the procedure (INR <2.0). There was a low incidence of small hematomas with either strategy (no significant difference) and no major vascular complications. No prolonged hospital stay due to an access site complication was observed, and no thromboembolic events occurred. In conclusion, transfemoral coronary angiography appears to be safe in patients on warfarin with an INR of 2.0 to 3.0).

Drug-eluting stents for coronary bifurcations: bench testing of provisional side-branch strategies.

The objective of this study was to bench-test provisional bifurcation stenting strategies to provide insights on how best to perform these with drug-eluting stents (DESs). Bifurcation stenting with DESs reduces restenosis compared with bare metal stents (BMSs). Outcomes with a single DES are better than with two DESs but if the main branch is stented, there needs to be a reliable strategy for provisionally stenting the side-branch with full ostial scaffolding and drug application. Stents were photographed in a phantom after deployment with different strategies. With provisional T-stenting, placement of the side-branch stent without gaps is difficult. The internal (or reverse) crush strategy fully scaffolds the side-branch ostium but is experimental. The culotte technique providing excellent side-branch ostial coverage is easier to perform with open-cell or large-cell stent design. In general, kissing balloon post-dilation improves stent expansion, especially at the ostium, and corrects distortion. However, a main-branch kissing balloon of smaller diameter than the deploying balloon causes distortion. Final main-branch postdilatation or sequential postdilatation prevents distortion after the internal crush strategy.