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.

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.

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.

Impact of N-acetylcysteine on endothelial function, B-type natriuretic peptide and renal function in patients with the cardiorenal syndrome: a pilot cross over randomised controlled trial.

BACKGROUND: Both heart and renal failure are characterised by increased systemic oxidative stress and endothelial dysfunction and occur in the cardiorenal syndrome (CRS). The aim of the present study was to assess the impact of N-acetylcysteine (NAC), a potent antioxidant, on endothelial function, B-type natriuretic peptide (BNP) and renal function in patients with CRS. METHODS: In a double blind, placebo controlled manner, we randomised nine stable outpatients with both heart failure (LVEF<40% and NYHA class II or III) and renal failure (Cockroft Gault clearance of 20-60ml/min) to placebo or NAC (500mg orally twice daily) for 28 days followed by a wash out period (>7 days) and crossover to the other treatment. RESULTS: Eight patients completed the study and all data (N=9) was used in the analysis. Mean forearm blood flow improved significantly with NAC with mean ratio of improvement of 1.99 (SEM: ±0.49) for NAC and 0.73 (SEM: ±0.23) for placebo with a p-value of 0.047. There was no significant difference in BNP (p=0.25), renal function (p=0.71) or NYHA class (p=0.5). No deaths occurred during the trial. CONCLUSION: In this pilot trial of patients with CRS, NAC therapy was associated with improved forearm blood flow. This may represent a general improvement in endothelial function and warrants further investigation of antioxidant therapy in these patients.

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).

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.