Medium-Term Bioresorbable Scaffold Outcomes Utilising Data From an Australian Clinical Quality Registry.

BACKGROUND: Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context. METHODS: A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation. RESULTS: Bioresorbable scaffolds patients (mean age 61.6±10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4±8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter ≤2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria. CONCLUSION: In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop.

An Australian longitudinal pilot study examining health determinants of cardiac outcomes 12 months post percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) is a very common revascularisation procedure for coronary artery disease (CAD). The purpose of this study was to evaluate cardiac outcomes, health related quality of life (HRQoL), resilience and adherence behaviours in patients who have undergone a PCI at two time points (6 and 12 months) following their procedure. METHODS: A longitudinal pilot study was conducted to observe the cardiac outcomes across a cohort of patients who had undergone a percutaneous coronary intervention (PCI). Participants who had undergone PCI 6 months prior were invited. Those participants who met the inclusion criteria and provided consent then completed a telephone survey (time point 1). These participants were then contacted 6 months later (i.e. 12 months post-intervention, time point 2) and the measures were repeated. RESULTS: All patients (n = 51) were recorded as being alive at time point 1. The multiple model indicated that controlling for other factors, gender was significantly associated with a linear combination of outcome measures (p = 0.004). The effect was moderate in magnitude (partial-η(2) = 0.303), where males performed significantly better than females 6 months after the PCI procedure physically and with mood. Follow-up univariate ANOVAs indicated that gender differences were grounded in the scale measuring depression (PHQ9) (p = 0.005) and the physical component score of the short form measuring HRQoL (SF12-PCS) (p = 0.003). Thirteen patients were lost to follow-up between time points 1 and 2. One patient was confirmed to have passed away. The pattern of correlations between outcome measures at time point 2 revealed statistically significant negative correlation between the PHQ instrument and the resilience scale (CD-RISC) (r = -0.611; p < 0.001); and the physical component score of the SF-12 instrument (r = -0.437; p = 0.054). CONCLUSIONS: Men were performing better than women in the 6 months post-PCI, particularly in the areas of mood (depression) and physical health. This pilot results indicate gender-sensitive practices are recommended particularly up to 6 months post-PCI. Any gender differences observed at 6 month appear to disappear at 12 months post-PCI. Further research into the management of mood particularly for women post-PCI is warranted. A more detailed inquiry related to access/attendance to secondary prevention is also warranted.

Right and left heart catheterization via an antecubital fossa vein and the radial artery--a prospective study.

Right heart catheterization has been described via the arm but previous reports have been retrospective, performed for limited indications, and may not give an accurate assessment of the success rate or safety of this technique. We sought to prospectively examine the feasibility and safety of left and right heart catheterization entirely via the arm using the radial artery and an antecubital fossa vein for a broad range of indications. Fifty-eight consecutive procedures were included. Transradial arterial access was successful in 57 patients (98%), right heart catheterization via the antecubital fossa vein was successful in 54 patients (93%) and bilateral catheterization from the arm was achieved in 53 patients (91%). Standard diagnostic catheterization was the most frequent procedure (59%), although thermodilution (6.9%), percutaneous coronary intervention (33%), and coronary sinus sampling (16%) were also performed in selected cases. Compared to a historical cohort of patients undergoing right and left heart catheterization via femoral access, mean procedural time (38 vs 47 minutes; P=.03) and screening time (8.1 vs 11.2 minutes; P<.001) were significantly reduced. There was 1 venous forearm hematoma that was managed conservatively. Right and left heart catheterization can be performed routinely via the arm in a broad range of patients and is associated with reduced procedural and fluoroscopy time as compared to femoral access. This approach can be considered for all patients in whom right and left heart catheterization is planned.

Cardiac epithelioid leiomyosarcoma and the role of cardiac imaging in the differentiation of intracardiac masses.

Primary malignant cardiac neoplasms are extremely rare and can be difficult to differentiate from other intracardiac masses. We present a case of left atrial epithelioid leiomyosarcoma and review the imaging modalities available to diagnose and characterize intracardiac masses. We demonstrate how multimodal imaging aided diagnosis and proved crucial to establishing the tumor's location, degree of invasion, and involvement of surrounding structures prior to surgical resection.

Side-branch wire entrapment during bifurcation PCI: avoidance and management.

An LAD/D1 bifurcation intervention was complicated by side-branch wire entrapment and unravelling requiring goose-neck snare removal. Residual microfilaments were retrieved from the main branch after further balloon inflations with a satisfactory final angiographic result and one-year follow-up. Various methods are available to avoid and deal with this complication.

The right not to know and coronary angiography: is the common law of Australia consistent with patients' wishes?

In "The Right Not to Know: Patient Autonomy or Medical Paternalism?" (2000) 7 JLM 286 Judy Gutman qualitatively examined the direction of the law relating to the duty of medical practitioners to disclose information to their patients about risks associated with medical treatment. Prompted by theoretical issues raised in that article, a quantitative study was performed. The study focused on the wishes of patients referred for coronary angiography regarding information about the risks inherent in that procedure. The results of the study contribute to the ongoing academic discussion about risk disclosure and consent to medical treatment and demonstrate a need for further empirical research in the area. The study also highlights the desirability of clinical medical practice conforming to the tenets of the common law and vice versa.