Hemostatic Profiles of Patients Who Underwent Transcatheter Versus Surgical Aortic Valve Replacement Versus Percutaneous Coronary Intervention.

Guidelines for transcatheter aortic valve replacement (TAVR) antithrombotic prophylaxis are extrapolated predominantly from percutaneous coronary intervention (PCI) data. Here, we examined temporal coagulation changes occurring in the early perioperative period to determine the pathobiologic validity of this supposition. This was a prospective observational study of consecutive patients who underwent transfemoral TAVR (n = 27), PCI (n = 12), or surgical aortic valve replacement (SAVR) requiring cardiopulmonary bypass and cross-clamping (n = 12). Blood samples were taken at 4 time points: T1 (baseline), after general anesthesia or sedation; T2, after heparin administration; T3, at the end of the procedure; and T4, 6 hours after the procedure. The samples were assessed concurrently using standard laboratory coagulation tests and viscoelastic tests of whole blood clotting, including the latest generation thromboelastometry (ROTEM sigma) and thromboelastometry (TEG 6s). Patients in the TAVR cohort were older and a had lower baseline hemoglobin level than patients in the PCI and SAVR cohorts. The baseline platelet function was similar between the TAVR and PCI cohorts and impaired in the SAVR cohort Figure S1. The baseline hemostatic measures were comparable among cohorts. Regarding the per-patient change from baseline, the TAVR cohort showed an overall more prothrombotic state than the other cohorts, with the most marked differences from the SAVR cohort after intraoperative heparin administration and from the PCI cohorts 6 hours after the procedure. In addition, the ROTEM and TEG parameters were well correlated but not interchangeable. In conclusion, patients who underwent TAVR have a more prothrombotic hemostatic profile than PCI and SAVR patients. These findings question the current guidelines that extrapolate antithrombotic regimens from PCI to TAVR settings.

Evaluation of latest viscoelastic coagulation assays in the transcatheter aortic valve implantation setting.

BACKGROUND: Point of care viscoelastic measures with thromboelastography (TEG; Haemonetics Corporation, Switzerland) and thromboelastometry (ROTEM, Tem Innovations GmbH, Germany) now supersede laboratory assays in the perioperative assessment and management of coagulation. To the best of our knowledge, this sophisticated coagulation assessment has not been performed to characterise thrombotic changes in the transcatheter aortic valve implantation (TAVI) setting, nor have the two latest iteration cartridge-based systems been directly compared in the elective perioperative period. METHODS: Patients undergoing TAVI were prospectively recruited. Samples (n=44) were obtained at four timepoints (postinduction of anaesthesia, postheparin (100 IU/kg), postprotamine (1 mg/100 IU heparin) and 6 hours postoperatively). Each sample was concurrently assessed with standard laboratory tests (prothrombin time/international normalised ratio, activated partial thromboplastin time, thrombin clotting time, platelet count and direct fibrinogen, ROTEMSigma and TEG6s). RESULTS: Clot strength showed a statistically significant increase postheparin/TAVI deployment. When considering the subgroup of samples taken following the administration heparin, the heparinase channel of the TEG6s did not yield clotting strength results in 55% of samples and clotting time exceeded the upper limit of normal in 70% of samples. It was retrospectively recognised that the arachidonic acid channel of the TEG6s Platelet Mapping Cartridge had been decommissioned prohibiting assessment of aspirin effect. CONCLUSIONS: This study demonstrated a small intraprocedural prothrombotic change of uncertain clinical importance during the transcatheter aortic valve procedure. Further comparison with percutaneous coronary intervention and aortic valve replacement cohorts are needed to assess the merits of current antithrombotic guidelines, which are extrapolated from the PCI setting. The heparin effect was more consistently quantified by ROTEM.

The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions.

BACKGROUND: The present study is a prospective observational single arm clinical investigation, with parallel bench test interrogation, aimed at investigating the technical feasibility, safety and clinical outcomes with the cone flare crush modified-T (CFCT) bifurcation stenting technique. Bifurcation percutaneous coronary intervention (PCI) remains an area of ongoing procedural evolution. More widely applicable and reproducible techniques are required. METHODS: From April 2018 until March 2019, 20 consecutive patients underwent bifurcation PCI using the CFCT technique with a Pt-Cr everolimus drug-eluting stent with a bioresorbable polymer. Exercise stress echocardiography was performed at 12-month follow-up. The primary outcome was a composite of cardiac related mortality, myocardial infarction, target lesion/vessel revascularization and stroke. Safety secondary endpoints included bleeding, all-cause mortality and stent thrombosis. RESULTS: All patients underwent a successful CFCT bifurcation procedure with no complications to 30-day follow-up. One patient met the primary endpoint requiring target lesion revascularization at 9 months for stable angina. There were no other primary or secondary outcome events in the cohort. There were no strokes, deaths, stent thrombosis or myocardial infarction during the follow-up period. The mean CCS score improved from 2.25 to 0.25 (p < 0.0001). Optical coherence tomography (OCT) and bench test findings indicated optimal side branch ostial coverage and minimal redundant strut material crowding the neo-carina. CONCLUSIONS: The CFCT technique appears to be a safe, efficacious and feasible strategy for managing coronary artery bifurcation disease. Expanded and randomized datasets with longer term follow-up are required to further explore confirm this feasibility data. (ANZCTR ID: ACTRN12618001145291).

Outcomes of the First 300 Cases of Transcatheter Aortic Valve Implantation at a High-Volume Australian Private Hospital.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) was first performed in Australia in 2008 with a steady increase in the number of implanting centres from seven in 2008 to 42 in 2018 (24 private and 18 public hospitals). There is limited published data on outcomes from Australian centres and no published data from Australian private hospitals. We describe outcomes of the first 300 cases at Queensland's first TAVI implanting private hospital. METHODS: From July 2015 to August 2018, 300 patients with severe, symptomatic aortic stenosis underwent TAVI at our centre. A heart team assessed all patients as suitable. All patients underwent computed tomography (CT) assessment of valve sizing and peripheral access. RESULTS: Median age was 85 years, 58% male, mean Society of Thoracic Surgeons' score 4.0%, 49% had New York Heart Association Class III/IV, 28% previous coronary artery bypass grafts, 14% peripheral vascular disease and 3.7% renal impairment (creatinine >177 µmol/L). At 30 days mortality was 1%, stroke 1.3%, myocardial infarction (MI) 0.3%, major vascular complication 3.0%, no life-threatening or disabling bleeding and new permanent pacemaker (PPM) requirement was 9.0%. Paravalvular leak was none, trace and mild in 27%, 53% and 20% respectively with 0.3%≥moderate paravalvular leak. At 1 year, mortality was 4.2%, stroke 2.1%, MI 0.3%, no life-threatening bleeding and PPM 11.4%. Lower rates of mortality, stroke, and major vascular complications were observed compared to the well-established TAVI centres in USA and Germany. CONCLUSION: Excellent TAVI clinical outcomes can be achieved in the Australian private hospital setting. Expert heart team assessment and CT guided procedural planning are key to these outcomes.

Factors Contributing to Acute Kidney Injury and the Impact on Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) patients are at a high risk of acute kidney injury (AKI). This study aimed to investigate AKI and the relationship with iodinated contrast media (ICM), whether there are significant pre- or peri- procedural variables predicting AKI, and whether AKI impacts on hospital length of stay and mortality. METHODS: Serum creatinine (SC) levels pre- and post- (peak) TAVR were recorded in 209 consecutive TAVR patients. AKI was defined by the Valve Academic Research Consortium 2 (VARC2) criteria. Baseline characteristics, procedural variables, hospital length of stay (LOS) and mortality at 72hours, 30 days and one year were analysed. RESULTS: Eighty-two of 209 (39%) patients suffered AKI. Mean ICM volume was 228cc, with no difference between patients with AKI and those with no AKI (227cc (213-240(95%CI)) vs 231cc (212-250) p=0.700)). Univariate and multivariate analysis demonstrated that chronic kidney disease, respiratory failure, previous stroke, the need for blood transfusion and valve repositioning were all predictors of AKI. Acute kidney injury increased LOS (5.6 days (3.8 - 7.5) vs 3.2 days (2.6 - 3.9) no AKI (P=0.004)) but was not linked to increased mortality. Mortality rates did increase with AKI severity. CONCLUSION: Acute kidney injury is a common complication of TAVR. The severity of AKI is important in determining mortality. Acute kidney injury appears to be independent of ICM use but pre-existing renal impairment and respiratory failure were predictors for AKI. Transcatheter aortic valve replacement device repositioning or retrieval was identified as a new risk factor impacting on AKI.

The effect of X-ray beam distortion on the Edwards Sapien XT(™) trans-catheter aortic valve replacement prosthesis.

INTRODUCTION: Profiling the Aortic root perpendicular to the fluoroscopic image plane will achieve a more successful implant position for trans-catheter aortic valve replacement (TAVR). This study aimed to investigate whether the divergent nature of the X-ray beam from the C-arm altered the appearance of the TAVR device. METHODS: Under bench-top testing, a 23, 26 and 29 mm Edwards Sapien XT valve was positioned coaxially at the bottom of a fluoroscopic image utilising 22 and 32 cm fields of view (FOV). The table was then moved so that the valve was positioned at the top of the image. The valve's appearance was scored using a previously published three tier classification tool (excellent, satisfactory and poor) and quantified with measurements. The number of degrees of C-arm rotation that were required to bring the valve back to a coaxial appearance was recorded. RESULTS: When using the 32 cm FOV, the valve's appearance changes from excellent to satisfactory. When a 22 cm FOV was used, the change is less marked. More C-arm rotation is required to bring the appearance back to coaxial with the 32 cm FOV. CONCLUSION: Not maintaining the valve in the centre of the image can distort the valves appearance. This has the potential to affect the final implantation depth.

Transcatheter valve-in-valve replacement of degenerated bioprosthetic aortic valves: a single Australian Centre experience.

BACKGROUND: Patients with degenerated surgical bioprosthetic valves may be at high risk for further surgery because of age, comorbidities and the difficulties of repeat procedures. Percutaneous valve-in-valve implantation offers what may be a simpler and safer procedure. METHODS: From May 2009 to March 2014 at the Prince Charles Hospital 1625 patients underwent surgical aortic valve replacement while 262 underwent transcatheter aortic valve implantation. Twelve patients had valve-in-valve implants for degenerated bioprosthetic aortic valves. RESULTS: These implants were deployed successfully without major valvular or paravalvular regurgitation. There were no periprocedural deaths, myocardial infarcts, neurological events or major vascular complications. Two patients died after 1624 and 1319days. Median survival for the remainder is 581days; they are stable with New York Heart Association class I/II functional status although 4 have a degree of patient-prosthesis mismatch, one has moderate aortic regurgitation and one required surgery for a late aortic dissection. CONCLUSION: Transcatheter valve-in-valve implantation is safe and effective treatment for patients with failed bioprosthetic aortic valves for whom reoperation is considered to be hazardous.

Pre-hospital ambulance notification and initiation of treatment of ST elevation myocardial infarction is associated with significant reduction in door-to-balloon time for primary PCI.

BACKGROUND: Mortality in ST elevation myocardial infarction (STEMI) is strongly predicted by the time from first medical contact to reperfusion. The aim of this study was to examine the impact of pre-hospital diagnosis by paramedics in the field on the door-to-balloon (DTB) times of patients with ST elevation myocardial infarction undergoing primary percutaneous intervention. METHODS: Paramedics in the field identified patients with ST elevation myocardial infarction on a 12-lead electrocardiograph, activated the cardiac catheter laboratory team from the field and initiated therapy with anticoagulants and antiplatelet agents in the pre-hospital setting. This cohort of patients was compared to a similar group of patients without pre-hospital diagnosis and notification. The primary outcome measure was DTB times. A secondary end point was mortality at 30 days and mortality at six months. RESULTS: A total of 281 patients, mean age of 61.1±12.9 years underwent primary percutaneous intervention with pre-hospital notification occurring in 63 cases. DTB times were lower in those with pre notification than in those without pre-hospital notification (40.4 vs. 75.6 minutes, p<0.001). This represented a 47.6% shorter DTB time. A non-statistically significant mortality reduction at one month and six months was observed in the pre-hospital notification group (1.6 versus 4.3%, p= 0.307 and 1.6 versus 6.4%, p= 0.203, respectively). CONCLUSION: Pre-hospital intervention at our centre had a powerful effect in reducing the time to reperfusion in patients with STEMI undergoing primary percutaneous intervention.

A rare mechanism of very late bare metal stent thrombosis--role of optical coherence imaging in its evaluation and management.

Very late stent thrombosis is an uncommon event following implantation with bare metal stents (BMS) in coronary arteries. Long term follow up studies have shown that a small number of BMS develop very late thrombosis following years of stability. Atherosclerotic transformation of neointimal tissue is increasingly being recognised as the cause of these adverse events. A 49 year-old male presented with acute inferior wall myocardial infarction resulting from thrombosis of the BMS implanted in his right coronary artery five years earlier. He was successfully thrombolysed and his coronary angiogram showed mild diffuse instent restenosis. The intravascular optical coherence tomography revealed instent neoatherosclerotic plaque rupture without any flow limiting stenosis as the likely culprit event.

Stenting an aortopulmonary conduit with peripheral cardiopulmonary bypass support.

Although surgically created aortopulmonary (AP) shunts are uncommon in the adult congenital heart disease population, they are often used in patients with pulmonary atresia. For these patients, the shunt is a vital supply of pulmonary blood flow and thus obstruction of the shunt may lead to pulmonary hypoperfusion and hypoxia thereby increasing morbidity and mortality. This report describes a safe and effective method of stenting the conduit with the hemodynamic support of peripheral cardiopulmonary bypass (PCB). Prior to the procedure, a multimodality assessment of a stenosis in a kinked AP conduit using computed tomography, angiography, intravascular ultrasound (IVUS), and pressure wire assessment (PWA) was utilized. While PCB, IVUS, and PWA have all been used to great effect in various clinical scenarios, the combined use of these techniques has not been previously been described in the setting of intervention in adult congenital heart disease.

The demographic profile of young patients (<45 years-old) with acute coronary syndromes in Queensland.

BACKGROUND: There is little data regarding the demographic profile of young (<45 years) Australian acute coronary syndrome patients. The aim of this study was to compare baseline characteristics, risk factor profile and outcomes of young patients compared with their older counterparts referred to two metropolitan Queensland hospitals. METHODS: Over a four-year period, data on acute coronary syndrome patients referred to The Prince Charles and Royal Brisbane Hospitals were retrospectively analysed. Three major groups were identified: <45 years, 45-60 years and those >60 years. Age, sex, body mass index, risk factor profile, degree of coronary disease, left ventricular dysfunction, mode of presentation, initial pharmacological therapy and mortality data were compared between the three groups. RESULTS: 4549 patients were analysed of whom, 277 were less than 45 years old. Younger patients tended to be male, more overweight and present more commonly with ST segment elevation myocardial infarction compared to their older counterparts. Smoking, family history and dyslipidaemia tended to occur more frequently in younger patients as compared to those >45 years. Those patients >45 years tended to present with non-ST segment elevation myocardial infarction and have a higher degree of ischaemic burden and left ventricular dysfunction. No patients <45 years died in their index admission at 30 days or at one year. CONCLUSIONS: Although young patients <45 years make up the minority (6.1%) of patients presenting with acute coronary syndrome and generally have a favourable prognosis, this paper highlights the need for aggressive risk factor modification, with particular attention to smoking and dyslipidaemia, before the onset of overt clinical disease.

Using DynaCT for the assessment of ilio-femoral arterial calibre, calcification and tortuosity index in patients selected for trans-catheter aortic valve replacement.

Adequate vascular access for femoral trans-catheter aortic valve replacement is fundamental to the success of the procedure. Assessment of vascular calibre, tortuosity and calcification is performed by angiography and multi-slice computed tomography (MSCT). Can DynaCT provide the same information as MSCT? 15 Patients underwent MSCT, angiography and DynaCT. Vessel diameter measurements were taken in three positions of the left and right ilio-femoral arteries. Tortuosity was assessed using an index of the direct distance and the distance taken by the artery between two points. Calcification was assessed in MSCT and DynaCT using a simple scoring system. Concordance correlation coefficient of arterial calibre between angiography and MSCT was 0.96 (95 % CI 0.94-0.97). DynaCT and angiography was 0.94 (95 % CI 0.91-0.96) and Dyna CT and MSCT, 0.95 (95 % CI 0.92-0.97). Bland-Altman tests demonstrate a mean difference between the angiogram and the MSCT of 0.06 mm (+0.97, -1.42), angiogram and DynaCT, 0.13 mm, (+1.00, -0.87), DynaCT and MSCT, 0.2 mm, (+1.15, -0.76). Tortuosity comparisons gave a median tortuosity index for MSCT 1.29 and DynaCT 1.23 (p = 0.472). Calcification comparisons of MSCT and DynaCT using correlation coefficients demonstrate a correlation of 0.245 (p = 0.378). Effective radiation doses were: DynaCT; 3.63 ± 0.65 mSv and angiography; 0.57 ± 0.72 mSv, MSCT; 7.15 ± 2.58 mSv. DynaCT is equal to MSCT and angiography in assessing femoral artery calibre. Like MSCT, it can assess tortuosity and can produce 3D images but is inferior in the assessment of calcification.

A repeat alcohol septal ablation procedure for hypertrophic obstructive cardiomyopathy where the first septal branch arose from the intermediate (ramus) artery.

Septal reduction therapy (via alcohol septal ablation or surgical myomectomy) is indicated in patients with hypertrophic obstructive cardiomyopathy (HOCM) who have NYHA class III/IV symptoms despite maximal medical therapy. In 90% of patients with HOCM the target septal artery arises from the LAD or diagonal artery. In the remaining 10% of cases it may arise from the ramus, proximal circumflex, or posterolateral or posterior descending branches of the RCA. We present a case where alcohol septal ablation was initially performed on the first septal branch arising from the left anterior descending artery. Left ventricular outflow tract (LVOT) obstruction with symptoms recurred. Upon repeat angiography, a large septal branch in fact arose from the proximal intermediate (ramus) artery. Alcohol ablation of this branch achieved a sustained response. This case highlights that correctly identifying the most suitable septal perforating artery, in addition to myocardial contrast echocardiography, may improve response rates and overall outcomes for patients with hypertrophic obstructive cardiomyopathy.

Fistula between subclavian arterial graft and oesophagus.

This is the first reported case of an oesophageal fistula arising from a subclavian arterial graft. A 28 year-old woman presented with massive haematemesis in severe haemorrhagic shock, three months after surgery to detach and relocate an aberrant right subclavian artery. Acutely, she was haemodynamically unstable and required transfusion of 45 units of blood. The fistula was identified with angiography (via the right brachial artery) after endoscopic and open visualisation were unsuccessful because of the torrential haemorrhage. The patient was stabilised and the fistula was managed with an endovascular covered stent. She had further surgery subsequently to remove the infected graft and to salvage the right arm.

Drug eluting stents trapping intramural hematoma in spontaneous coronary artery dissection and healing pattern at six months: optical coherence tomography findings.

Spontaneous coronary artery dissections (SCAD) are often difficult to diagnose and manage. Intravascular imaging such as optical coherence tomography (OCT) improves diagnosis and may assist in management. Recent data suggest that percutaneous coronary interventions (PCI) in in SCAD are associated with poor outcomes. This report provides striking OCT images of potential complications associated with PCI in SCAD, as well as demonstrates medium term OCT data in residual hematoma healing and stent coverage in SCAD.

Impact of optimising fluoroscopic implant angles on paravalvular regurgitation in transcatheter aortic valve replacements - utility of three-dimensional rotational angiography.

AIMS: The clinical value of optimising implant angles during transcatheter aortic valve replacements (TAVR) remains undefined. The Aortic Valve Guide (AVG) is a proprietary software that provides structured analysis of three-dimensional images from rotational angiography (DynaCT). This study compares AVG with preprocedural multislice computed tomography (MSCT) and DynaCT in optimal implant angle prediction for TAVR, and evaluates if an optimised implant angle is associated with reduced paravalvular regurgitation (PVR). METHODS AND RESULTS: One hundred and six consecutive patients were included, comprising three groups. Group 1 (n=19) underwent no preprocedural MSCT or DynaCT (or AVG); Group 2 (n=44) underwent periprocedural DynaCT, without AVG; Group 3 (n=43) had DynaCT with AVG. Implant angles yielded were graded as excellent, satisfactory or poor. Group 3 were more likely than Groups 2 and 1 to have excellent implant angles (83.7% vs. 52.3% vs. 42.1%, respectively, p=0.001). In 100 patients who had 30-day transthoracic echocardiogram follow-up, an excellent implant angle was significantly more likely to be associated with no PVR than a non-excellent angle (41.3% vs. 21.6%, respectively, p=0.045), independent of operator experience and THV used. CONCLUSIONS: Optimising implant angles may be important in reducing PVR. This is significantly more likely to be achieved with AVG rotational angiography.