First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.

Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.

Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry.

Background: The CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. Methods: This was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. Results: We enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). Conclusions: The Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrialsgov Identifier: NCT03752866.

Third-Generation Transcatheter Aortic Heart Valve with Reverse Parachute Sealing Cuff in Patients with Aortic Valve Disease.

BACKGROUND: The Navitor (Abbott Inc, IL, USA) transcatheter heart valve is a novel third-generation self-expanding bioprosthesis with specific features to mitigate paravalvular regurgitation (PVR). Owing to its novelty, there is a paucity of data on its application in clinical practice. METHODS: Consecutive cohort analysis of the use of the Navitor system in an as-treated clinical setting at a quaternary heart hospital. RESULTS: Sixty consecutive non-clinical trial patients treated with Navitor were identified. All patients underwent a successful procedure. The mean age was 79.3 years (±SD 7.82), 56.67% (n=34) were female, and the mean STS score was 4.87 (±SD 5.70). At 30 days post-procedure, all patients were alive with no readmissions for heart failure. One patient had a major vascular complication (1.7%). Four patients (7.14% of patients without a pre-existing pacemaker) received a new permanent pacemaker. Two patients (3.4%) had a non-disabling stroke. PVR at 30 days was trivial or none in 75% of patients, and no patient had worse than mild PVR. CONCLUSIONS: The Navitor system in this as-treated cohort was associated with favourable clinical, haemodynamic, and safety outcomes.

30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort. METHODS AND RESULTS: This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cm2 and mean aortic valve gradient (AVG) of 9.6 (±6.2) mmHg. CONCLUSION: This analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.

Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry.

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected 'standard-of-care' clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.

Operator and Institutional Requirements for Transcatheter Mitral Valve Therapies in Australia: a CSANZ and ANZSCTS Position Statement.

This expert Position Statement is a description of the requirements for Accreditation for transcatheter mitral valve therapy (TMVT) in Australia. The requirements include the need for a multidisciplinary Heart Team review of individual cases, mandatory reporting of outcome data to a national TMVT Registry, and accreditation of individuals and institutions by the Conjoint Accreditation Committee, the assigned accreditation authority.

Plaster pipes and crystalized graphite: Open transventricular transcatheter aortic valve replacement for failed mechanical aortic valve prostheses in the porcelain aorta.

Patients with a true porcelain aorta and a failed mechanical aortic valve prosthesis have limited treatment options. Using a hybrid of an open trans-ventricular approach with peripheral cardiopulmonary bypass and integration of transcatheter techniques this challenge can be overcome. Trans-ventricular mechanical valve extraction (with transcatheter endovascular occlusion and cardioplegia) followed by direct ante-grade transcatheter heart valve implantation offers a potential solution to this conundrum. The procedure described is a novel technique that allows for the effective treatment of patients with failed mechanical surgical aortic valve prostheses in the setting of an inoperable porcelain aorta. In addition, a collaborative integrated multi-disciplinary heart team environment is required for the management of these complex patients.

Emergency treatment of acute decompensated critical aortic stenosis with transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is relatively contraindicated in the bicuspid aortic valve, and to our knowledge has not been tried where the true native annulus is of a size far in excess of current device capabilities. We present here a case of a successful emergency TAVI of a 73-year-old previously healthy man, who presented with cardiogenic shock, ventricular tachycardia storm and severe left ventricular dysfunction because of the underlying critical bicuspid aortic stenosis with aortic annulus area of 991.9 mm2 and associated moderate aortic incompetence (the Society of Thoracic Surgeons (STS) risk score; score mortality of 40.9%). Despite the critical condition of the patient and technically challenging anatomy, successful TAVI was performed and the patient remains well with near-normal left ventricle (LV) function at 6 months follow-up.

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).

Hemodynamic Validation of the E/e' Ratio as a Measure of Left Ventricular Filling Pressure in Patients With Non-ST Elevation Myocardial Infarction.

The E/e' ratio has an established role in the assessment of left ventricular filling pressure (LVFP) in stable patients, but its accuracy in acute myocardial ischemia is less well established. The aim of this study was to validate the relation between the E/e' ratio and invasively measured LVFP in patients with non-ST elevation myocardial infarction (NSTEMI). A total of 120 unselected patients with NSTEMI underwent cardiac catheterization with measurement of left ventricular end-diastolic pressure (LVEDP; elevated ≥15 mm Hg) and Doppler echocardiography with either simultaneous (n = 30) or same-day (n = 90) measurement of E/e'. Patients were aged 64.1 ± 11.8 years, 72% were male and mean left ventricular ejection fraction was 48.0 ± 20.9%. Septal, lateral, and average E/e' ratios all showed a significant correlation with LVEDP (Pearson's r: 0.42, 0.43, 0.48, respectively [all p <0.001]). Receiver operating characteristics curves showed an area under the curve of 0.72, 0.72, and 0.75 (all p <0.001) for septal, lateral, and average E/e', respectively. The sensitivity, specificity, positive (PPV), and negative (NPV) predictive values for the guideline-recommended threshold of average E/e' >14 for elevated LVEDP was 27%, 93%, 79%, and 44%, respectively. Utilizing lower E/e' boundaries of 6, 7, and 8 for lateral, average, and medial E/e', respectively, improved the NPV to ≥80% for each parameter. In conclusion, the E/e' ratio is a robust measure of LVFP during acute NSTEMI using upper and lower thresholds to achieve a high PPV and NPV, respectively, with the use of adjunctive guideline-recommend measures required in patients with nonconclusive E/e'.

The Prophylactic Chimney Snorkel Technique for the Prevention of Acute Coronary Occlusion in High Risk for Coronary Obstruction Transcatheter Aortic Valve Replacement/Implantation Cases.

Coronary occlusion (immediate or delayed) is an uncommon but potentially devastating complication of transcatheter aortic valve replacement/implantation (TAVR/TAVI). Several patient-related, anatomical, device and procedural risk factors can be assessed to risk-stratify patients and assist in procedural planning. In patients at high risk for coronary occlusion, coronary protection measures should be employed. In the highest risk patients, consideration should be given to prophylactic techniques to prevent coronary occlusion. This how-to-do-it report provides a framework for risk assessment for coronary occlusion followed by a step-wise description of the emerging chimney snorkel coronary stenting technique as a predictable procedural approach for the management of this potentially challenging clinical scenario.

Drug-Eluting Stents Versus Coronary Artery Bypass Grafts for Left Main Coronary Disease: A Meta-Analysis and Review of Randomised Controlled Trials.

BACKGROUND: Revascularisation of left main coronary artery (LMCA) disease can be potentially managed with percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). Recent randomised controlled trial (RCT) data have added to the literature on this subject and this meta-analysis aims to assess the state of the data to assist in guiding patient treatment decisions. METHODS: A systematic literature search of Cochrane Library, EMBASE, OVID, and PubMed Medline was performed. Randomised controlled trials of patients with LMCA disease undergoing PCI with drug eluting stents or CABG were included. Clinical outcomes and adverse events were assessed and analysed. RESULTS: Four suitable RCTs of adequate quality and follow-up were identified. The incidence of major adverse cardiac and cerebrovascular events (MACCE) at 3 to 5 years of follow-up was significantly increased with PCI compared to CABG (23.3% vs 18.2%, OR 1.37; 95% CI: 1.18-1.58; p=<0.0001; I2=0%) and was largely driven by more repeat revascularisation procedures among patients treated with PCI. There was no statistically significant difference in rates of mortality, myocardial infarction or stroke (either individually or when these outcomes were combined as a composite endpoint). CONCLUSIONS: Coronary artery bypass grafting and PCI both represent reasonable treatment modalities for LMCA disease in appropriately selected patients. However, where CABG is feasible it offers superior long-term freedom from repeat revascularisation. Longer-term follow-up is required to further clarify the durability of mortality outcomes, especially in patients treated with PCI.

Transcatheter Aortic Valve Replacement is Associated with Comparable Clinical Outcomes to Open Aortic Valve Surgery but with a Reduced Length of In-Patient Hospital Stay: A Systematic Review and Meta-Analysis of Randomised Trials.

BACKGROUND: Aortic valve replacement is indicated in patients with severe symptomatic aortic stenosis (AS). Transcatheter aortic valve replacement (TAVR) has evolved as a potential strategy in a growing proportion of patients in preference to surgical aortic valve replacement (SAVR). This meta-analysis aims to assess the differential outcomes of TAVR and SAVR in patients enrolled in published randomised controlled trials (RCTs). METHODS: A systematic literature search of Cochrane Library, EMBASE, OVID, and PubMed MEDLINE was performed. Randomised controlled trials of patients with severe AS undergoing TAVR compared with SAVR were included. Clinical outcomes and procedural complications were assessed. RESULTS: Five RCTs with a total of 3,828 patients (1,928 TAVR and 1,900 SAVR) were analysed. There was no statistically significant difference in combined rates of all-cause mortality and stroke at 30-days for TAVR vs SAVR (6.3% vs 7.5%; OR 0.83; 95% CI: 0.64-1.08; P=0.17) or at 12 months (17.2% vs 19.2%; OR 0.87; 95% CI: 0.73-1.03; P=0.29). No statistically significant difference was seen for death or stroke separately at any time point although a numerical trend in favour of TAVR for both was recorded. Length of in-patient stay was significantly less with TAVR vs SAVR (9.6 +/- 7.7 days vs 12.2 +/- 8.8 days; OR -2.94; 95% CI: -4.64 to -1.24; P=0.0007). Major vascular complications were more frequent in patients undergoing TAVR vs SAVR (8.2% vs. 4.0%; OR 2.15; 95% CI: 1.62-2.86; P <0.00001) but major bleeding was more common among SAVR patients (20.5% vs 44.2%; OR 0.34; 95% CI: 0.22-0.52; P=<0.00001). CONCLUSIONS: Transcatheter aortic valve replacement and SAVR are associated with overall similar rates of death and stroke among patients in intermediate to high-risk cohorts but with reduced length of in-patient hospital stay.

The Impact of Peripheral Nerve Stimulation on Coronary Blood Flow and Endothelial Function.

PURPOSE: The geko™ device is a small transcutaneous nerve stimulator that is applied non-invasively to the skin over the common peroneal nerve to stimulate peripheral blood flow. The purpose of this study was to investigate the effect of peripheral nerve stimulation on coronary flow dynamics and systemic endothelial function. METHODS: We enrolled 10 male patients, age 59 ± 11 years, with symptomatic obstructive coronary disease undergoing percutaneous coronary intervention (PCI). Coronary flow dynamics were assessed invasively using Doppler flow wire at baseline and with nerve stimulation for 4 min. Measurements were taken in the stenotic coronary artery and in a control vessel without obstructive disease. At a separate visit, peripheral blood flow at the popliteal artery (using duplex ultrasound assessment) and endothelial function assessed by peripheral artery tonometry (PAT) were measured at baseline and after one hour of nerve stimulation. RESULTS: Compared to baseline, there was a significant increase in coronary blood flow as measured by average peak velocity (APV) in the control vessel with nerve stimulation (20.3 ± 7.7 to 23.5 ± 10 cm/s; p = 0.03) and non-significant increase in the stenotic vessel (21.9 ± 12 to 23.9 ± 12.9 cm/s; p = 0.23). Coronary flow reserve did not change significantly. Reactive hyperemia-peripheral arterial tonometry (Rh-PAT) increased from 2.28 ± 0.39 to 2.67 ± 0.6, p = 0.045. CONCLUSIONS: A few minutes of peripheral nerve stimulation may improve coronary blood flow. This effect is more prominent in non-stenotic vessels. Longer stimulation improved endothelial function.

Short-term outcomes in patients with acute coronary syndrome treated with direct bioresorbable scaffold deployment.

BACKGROUND: Direct coronary stenting is a validated therapeutic option for coronary lesions. We studied the feasibility of direct deployment with a bioresorbable vascular scaffold (BVS) in acute coronary syndrome (ACS). METHODS: Demographic, procedural, and survival data were obtained for patients who had direct scaffold deployment with BVS from 1 May 2013 to 1 April 2014. RESULTS: We performed a retrospective review of nine patients which included eight patients having ST-elevation myocardial infarction. There were no cases of worsening coronary flow, scaffold thrombosis, target lesion revascularization or death up to 30 days post intervention. CONCLUSION: Direct BVS deployment in ACS appears safe and feasible.

Ultrasound guidance for vascular access in patients undergoing coronary angiography via the transradial approach.

BACKGROUND: We assessed the value of routine real-time ultrasound (RTUS) guidance to improve transradial access (TRA) for cardiac catheterization. METHODS: A prospective, single-center descriptive observational study of patients presenting for cardiac catheterization via the transradial approach. The first phase of the study enrolled 100 consecutive patients who underwent TRA without the assistance of RTUS followed by 100 consecutive patients who underwent TRA using RTUS guidance. The primary outcome measure was time between needle attempts for arterial access and sheath insertion. RESULTS: There were no statistically significant differences in any outcome measures. Median time between commencing needle attempts for arterial access to sheath insertion was 82.5 seconds (interquartile range [IQR], 64-161.5 seconds) with no RTUS guidance vs 84 seconds (IQR, 52.75-122.5 seconds) with RTUS; P=.19. Median number of needle passes through the skin required was 1 (IQR, 1-3) with no RTUS guidance vs 2 (IQR, 1-3) with RTUS; P=.25. Median number of arterial punctures was 1 (IQR, 1-1) with no RTUS guidance vs 1 (IQR, 1-1) with RTUS; P=.21. CONCLUSION: Routine RTUS guidance to assist in TRA does not significantly improve parameters of successful vascular access among high-volume radial operators. However, RTUS guidance should still be considered in selected cases and among less experienced radial practitioners.

Cardiac catheterization is associated with superior outcomes for survivors of out of hospital cardiac arrest: review and meta-analysis.

AIMS: Survivors of out-of-hospital cardiac arrest (OHCA) have a high rate of morbidity and mortality. Invasive cardiac assessment with coronary angiography offers the potential for improving outcomes by facilitating early revascularization. The aim of the present study was to review the published data on early coronary angiography for survivors of OHCA, and its impact on survival and neurological outcomes. METHODS: Medline, Embase and PubMed were searched with a structured search query. The primary outcome was in-hospital (or if not available, 30 day or 6 month) survival. Rates of survival with good neurological outcome were a secondary endpoint. The time period of the search was from 1 January 1980 to 1 January 2014. Data was pooled with means and 95% CI interval calculated. Meta-analysis of the main outcomes was performed using a weighted random effects model. RESULTS: Following review of all identified records, 105 relevant full text articles were retrieved. Fifty had adequate outcome information stratified by the use of coronary angiography for analysis. In studies where a control group was available for comparison, the overall survival in the acute angiography group was 58.8% versus 30.9% in the control group (Odds ratio 2.77, 95% CI 2.06-3.72). Survival with good neurological outcome (as per the Utstein framework) in the early angiography group was 58% versus 35.8% in the control group (Odds ratio 2.20, 95% CI 1.46-3.32). CONCLUSIONS: Early coronary angiography in patients following OHCA is associated with improved outcome and better survival.