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1.
Dermatol Ther ; 34(1): e14416, 2021 01.
Article in English | MEDLINE | ID: mdl-33068030

ABSTRACT

The rise in popularity and demand for nonsurgical injectable aesthetic procedures is inherently accompanied by an increase in reported complications, particularly those related to infection. Aseptic technique is under the control of aesthetic practitioners and can be modified to minimize the potential for cross-contamination and infection. This should be a key consideration during all clinical procedures, particularly those involving breach of the skin's natural defenses and the use of soft tissue filler. A consensus group of five UK expert aesthetic clinicians were convened to discuss current best practice for aseptic techniques in medical aesthetics. The aim of the consensus group was to recommend a step-by-step procedure to achieve optimal aseptic practice in private clinics, and define important considerations for reducing infection risk during the whole patient journey: pre-, during- and postaesthetic procedure. Recommendations were based on current evidence and extensive clinical experience. Various procedure recommendations were made to achieve and maintain a high standard of asepsis and infection control. Guidance was divided into three phases for patients and health care professionals, covering preprocedure (including patient selection), during-procedure, and postprocedure considerations. Although adherence to standard hospital guidance on handwashing and cleanliness measures is a cornerstone of controlling cross-contamination, aesthetic clinics carry a high potential risk of infection-particularly as popular treatments with dermal fillers primarily involve the face. This expert consensus guidance recommends procedures to mitigate the potential risks of asepsis.


Subject(s)
Cosmetic Techniques , Cosmetic Techniques/adverse effects , Esthetics , Face , Humans , Infection Control , Injections
2.
BMC Cardiovasc Disord ; 20(1): 148, 2020 03 24.
Article in English | MEDLINE | ID: mdl-32204693

ABSTRACT

BACKGROUND: Where each patient has all three conduits of internal mammary artery (IMA), saphenous vein graft (SVG) and radial artery (RA), most confounders affecting comparison between conduits can be mitigated. Additionally, since SVG progressively fails over time, restricting patient angiography to the late period only can mitigate against early SVG patency that may have occluded in the late period. METHODS: Research protocol driven conventional angiography was performed for patients with at least one of each conduit of IMA, RA and SVG and a minimum of 7 years postoperative. The primary analysis was perfect patency and secondary analysis was overall patency including angiographic evidence of conduit lumen irregularity from conduit atheroma. Multivariable generalized linear mixed model (GLMM) was used. Patency excluded occluded or "string sign" conduits. Perfect patency was present in patent grafts if there was no lumen irregularity. RESULTS: Fifty patients underwent coronary angiography at overall duration postoperative 13.1 ± 2.9, and age 74.3 ± 7.0 years. Of 196 anastomoses, IMA 62, RA 77 and SVG 57. Most IMA were to the left anterior descending territory and most RA and SVG were to the circumflex and right coronary territories. Perfect patency RA 92.2% was not different to IMA 96.8%, P = 0.309; and both were significantly better than SVG 17.5%, P < 0.001. Patency RA 93.5% was also not different to IMA 96.8%, P = 0.169, and both arterial conduits were significantly higher than SVG 82.5%, P = 0.029. Grafting according to coronary territory was not significant for perfect patency, P = 0.997 and patency P = 0.289. Coronary stenosis predicted perfect patency for RA only, P = 0.030 and for patency, RA, P = 0.007, and SVG, P = 0.032. When both arterial conduits were combined, perfect patency, P < 0.001, and patency, P = 0.017, were superior to SVG. CONCLUSIONS: All but one patent internal mammary artery or radial artery grafts had perfect patency and had superior perfect patency and overall patency compared to saphenous vein grafts.


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease/surgery , Mammary Arteries/surgery , Radial Artery/transplantation , Saphenous Vein/transplantation , Vascular Patency , Aged , Aged, 80 and over , Coronary Angiography , Coronary Artery Bypass/adverse effects , Female , Graft Occlusion, Vascular/diagnostic imaging , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/physiopathology , Humans , Male , Mammary Arteries/diagnostic imaging , Mammary Arteries/physiopathology , Middle Aged , Prospective Studies , Radial Artery/diagnostic imaging , Radial Artery/physiopathology , Risk Factors , Saphenous Vein/diagnostic imaging , Saphenous Vein/physiopathology , Time Factors , Treatment Outcome
3.
BMC Med ; 17(1): 72, 2019 04 03.
Article in English | MEDLINE | ID: mdl-30943979

ABSTRACT

BACKGROUND: Risk prediction for patients with suspected coronary artery disease is complex due to the common occurrence of prior cardiovascular disease and extensive risk modification in primary care. Numerous markers have the potential to predict prognosis and guide management, but we currently lack robust 'real-world' evidence for their use. METHODS: Prospective, multicentre observational study of consecutive patients referred for elective coronary angiography. Clinicians were blinded to all risk assessments, consisting of conventional factors, radial artery pulse wave analysis, 5-minute heart rate variability, high-sensitivity C-reactive protein and B-type natriuretic peptide (BNP). Blinded, independent adjudication was performed for all-cause mortality and the composite of death, myocardial infarction or stroke, analysed with Cox proportional hazards regression. RESULTS: Five hundred twenty-two patients were assessed with median age 66 years and 21% prior revascularization. Median baseline left ventricular ejection fraction was 64%, and 62% had ≥ 50% stenosis on angiography. During 5.0 years median follow-up, 30% underwent percutaneous and 16% surgical revascularization. In multivariate analysis, only age and BNP were independently associated with outcomes. The adjusted hazard ratio per log unit increase in BNP was 2.15 for mortality (95% CI 1.45-3.19; p = 0.0001) and 1.27 for composite events (1.04-1.54; p = 0.018). Patients with baseline BNP > 100 pg/mL had substantially higher mortality and composite events (20.9% and 32.2%) than those with BNP ≤ 100 pg/mL (5.6% and 15.5%). BNP improved both classification and discrimination of outcomes (p ≤ 0.003), regardless of left ventricular systolic function. Conversely, high-sensitivity C-reactive protein, pulse wave analysis and heart rate variability were unrelated to prognosis at 5 years after risk modification and treatment of coronary disease. CONCLUSIONS: Conventional risk factors and other markers of arterial compliance, inflammation and autonomic function have limited value for prediction of outcomes in risk-modified patients assessed for coronary disease. BNP can independently identify patients with subtle impairment of cardiac function that might benefit from more intensive management. TRIAL REGISTRATION: Clinicaltrials.gov, NCT00403351 Registered on 22 November 2006.


Subject(s)
Biomarkers/blood , Coronary Artery Disease/diagnosis , Natriuretic Peptide, Brain/blood , Aged , Australia/epidemiology , C-Reactive Protein/analysis , C-Reactive Protein/metabolism , Cause of Death , Coronary Angiography , Coronary Artery Disease/blood , Coronary Artery Disease/complications , Coronary Artery Disease/mortality , Female , Humans , Longitudinal Studies , Male , Middle Aged , Myocardial Infarction/blood , Myocardial Infarction/diagnosis , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Natriuretic Peptide, Brain/analysis , Predictive Value of Tests , Prognosis , Stroke/blood , Stroke/complications , Stroke/diagnosis , Stroke/mortality
4.
Heart Lung Circ ; 26(12): 1303-1309, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28389196

ABSTRACT

BACKGROUND: Secondary prevention strategies after percutaneous coronary intervention (PCI) include statins and dual anti-platelet therapy, however there are significant gaps between guidelines and practice. Contemporary PCI practice requires comprehensive data collection to allow dynamic auditing and benchmarking of key performance and safety indices. Genesis HeartCare is Australia's largest collaborative venture of cardiologists, practising at over 40 public and private hospitals. We hypothesised that measurement and local reporting of data would improve patient outcomes through improving compliance with guideline therapies. METHODS: Real-time benchmarking via a national clinical quality and outcomes register, the Genesis Cardiovascular Outcomes Registry (GCOR-PCI). GCOR-PCI prospectively collected clinical, procedural, medication and outcomes data for 6720 consecutive patients undergoing PCI from 10 private hospitals across Australia. Key performance outcomes benchmarked against the aggregated study cohort and international standards were reported to individual sites. The main outcome measure was compliance with guideline medications (statins, anti-platelet agents). RESULTS: Early data identified specific practice patterns associated with lower rates of statin therapy post-PCI, which led to changes in practice. Between the first and latest year of data collection there was significant improvement in the rates of statin therapy at discharge (92.1 vs. 94.4% p<0.03) and 12 months post-PCI (87.0 vs. 92.2% p<0.001) and of antiplatelet therapy at 12 months (90.7 vs. 94.3% p<0.001). CONCLUSIONS: This large-scale collaboration provides a platform for the development of quality improvement initiatives. Establishment of this clinical quality registry improved patient care by identifying and monitoring gaps in delivery of appropriate therapies, driving key practice change.


Subject(s)
Acute Coronary Syndrome/surgery , Guideline Adherence/standards , Percutaneous Coronary Intervention/standards , Postoperative Care/standards , Postoperative Complications/prevention & control , Quality Improvement , Secondary Prevention/standards , Aged , Australia/epidemiology , Benchmarking/methods , Female , Guideline Adherence/trends , Humans , Incidence , Male , Patient Compliance , Postoperative Complications/epidemiology , Registries
6.
J Drugs Dermatol ; 14(12): 1444-52, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26659938

ABSTRACT

BACKGROUND: Juvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement. OBJECTIVE: Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®). METHODS: This study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan's Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥ 1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment. RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P ≤ .03), perioral lines (P ≤ .04), and oral commissures (P ≤ .03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler. CONCLUSIONS: Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.


Subject(s)
Hyaluronic Acid/analogs & derivatives , Lidocaine/therapeutic use , Lip/anatomy & histology , Lip/drug effects , Mouth/anatomy & histology , Mouth/drug effects , Adolescent , Adult , Aged , Cosmetic Techniques , Female , Humans , Hyaluronic Acid/adverse effects , Hyaluronic Acid/therapeutic use , Lidocaine/adverse effects , Male , Middle Aged , Prospective Studies , Rejuvenation , Skin/anatomy & histology , Skin/drug effects , Young Adult
7.
J Cosmet Laser Ther ; 16(4): 171-9, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24689357

ABSTRACT

INTRODUCTION: Juvéderm® VOLUMA® with Lidocaine is a hyaluronic acid (HA)-based injectable gel that is used to restore the volume of the face. This study was designed to assess the real-world effectiveness of this HA gel over 21 days when used for mid-face augmentation in normal, healthy subjects desiring aesthetic improvement. MATERIALS AND METHODS: This prospective, observational, single-arm, open-label post-marketing study enrolled 115 healthy subjects, from five European centers. The primary objective was to evaluate subject-reported satisfaction and experience of the treatment across a range of doses of Juvéderm® VOLUMA® with Lidocaine (1 ml/2 ml/combination), immediately after injection and 21 days post-treatment. RESULTS: Subject satisfaction questionnaire (SSQ) scores of Delighted or Happy were given by 95.6% of subjects immediately after injection, and by 93.7% of subjects at Day 21. Overall, subject and investigator satisfaction with cosmetic effect and smoothness was very positive. Pain was minimal; most subjects experienced only minor degrees of discomfort, and this was mainly related to the procedure itself. CONCLUSIONS: Juvéderm® VOLUMA® with Lidocaine was well accepted by both subjects and investigators, associated with high levels of satisfaction, was considered smooth and easy to use, and was well tolerated when used for the treatment of mid-face area volume enhancement.


Subject(s)
Hyaluronic Acid/administration & dosage , Patient Satisfaction , Skin Aging , Adult , Aged , Drug Combinations , Esthetics , Face , Female , Gels , Humans , Hyaluronic Acid/adverse effects , Injections/adverse effects , Injections/methods , Male , Middle Aged , Pain/etiology , Prospective Studies , Surveys and Questionnaires , Time Factors
8.
Heart Lung Circ ; 23(6): 527-33, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24560401

ABSTRACT

PURPOSE: The international multicentre FAME Study (n=1,005) demonstrated significant health benefits for patients undergoing multivessel percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) measurement compared with angiography guidance alone (ANGIO). We determined the cost-effectiveness and the public health/budget impact for Australia. METHODS: We performed a prospective economic evaluation comparing FFR vs. ANGIO in patients with multivessel disease based on original patient-level FAME data. We used Australian utilities (EQ-5D) and costs to calculate quality-adjusted life years (QALYs) and incremental cost-effectiveness adopting the societal perspective. The public health and budget impact from the payer's perspective was based on Australian PCI registries. Uncertainty was explored using deterministic sensitivity analyses and the bootstrap method (n=5,000 samples). RESULTS: The cost-effectiveness analysis showed that FFR was cost-saving and reduces costs by 1,776 AUD per patient during one year. Over a two-year time horizon, the public health impact ranged from 7.8 to 73.9 QALYs gained and the budget impact from 1.8 to 14.5 million AUD total cost savings. Sensitivity analyses demonstrated that FFR was cost-saving over a wide range of assumptions. CONCLUSIONS: FFR-guided PCI in patients with multivessel coronary disease substantially reduces cardiac events, improves QALYs and is cost-saving in the Australian health care system.


Subject(s)
Coronary Angiography/economics , Coronary Artery Disease/economics , Coronary Artery Disease/surgery , Percutaneous Coronary Intervention/economics , Australia , Coronary Angiography/methods , Costs and Cost Analysis , Percutaneous Coronary Intervention/methods
9.
J Clin Med ; 12(4)2023 Feb 20.
Article in English | MEDLINE | ID: mdl-36836219

ABSTRACT

BACKGROUND: Readmissions within 1 year after percutaneous coronary intervention (PCI) are common (18.6-50.4% in international series) and a burden to patients and health services, however their long-term implications are not well characterised. We compared predictors of 30-day (early) and 31-day to 1-year (late) unplanned readmission and the impact of unplanned readmission on long-term clinical outcomes post-PCI. METHODS: Patients enrolled in the GenesisCare Cardiovascular Outcomes Registry (GCOR-PCI) from 2008 to 2020 were included in the study. Multivariate logistic regression analysis was performed to identify predictors of early and late unplanned readmission. A Cox proportion hazards regression model was used to explore the impact of any unplanned readmission during the first year post-PCI on the clinical outcomes at 3 years. Finally, patients with early and late unplanned readmission were compared to determine which group was at the highest risk of adverse long-term outcomes. RESULTS: The study comprised 16,911 consecutively enrolled patients who underwent PCI between 2009-2020. Of these, 1422 patients (8.5%) experienced unplanned readmission within 1-year post-PCI. Overall, the mean age was 68.9 ± 10.5 years, 76.4% were male and 45.9% presented with acute coronary syndromes. Predictors of unplanned readmission included increasing age, female gender, previous CABG, renal impairment and PCI for acute coronary syndromes. Unplanned readmission within 1 year of PCI was associated with an increased risk of MACE (adjusted HR 1.84 (1.42-2.37), p < 0.001) and death over a 3-year follow-up (adjusted HR 1.864 (1.34-2.59), p < 0.001) compared with those without readmission within 1-year post-PCI. Late compared with early unplanned readmission within the first year of PCI was more frequently associated with subsequent unplanned readmission, MACE and death between 1 and 3 years post-PCI. CONCLUSIONS: Unplanned readmissions in the first year following PCI, particularly those occurring more than 30 days after discharge, were associated with a significantly higher risk of adverse outcomes, such as MACE and death at 3 years. Strategies to identify patients at high risk of readmission and interventions to reduce their greater risk of adverse events should be implemented post-PCI.

10.
Aesthet Surg J Open Forum ; 4: ojac047, 2022.
Article in English | MEDLINE | ID: mdl-35795884

ABSTRACT

Background: Hyaluronic acid (HA) injectable gels are used to define, enhance, and volumize facial regions, such as the lips, a common treatment area. Objectives: To evaluate the effectiveness and safety of the HA injectable gel Juvéderm Volift (Allergan, Aesthetics, an AbbVie Company Irvine, CA) with Lidocaine (VYC-17.5L) for lip augmentation in real-world clinical practice. Methods: This prospective, open-label, multicenter study initially designed for 6 months, then extended to 12 months, enrolled adults with an overall grade of minimal to moderate on the Lip Fullness Scale 2 (LFS2). Optional touch-up and repeat treatments occurred at day 14 and month 12, respectively. The primary endpoint was a ≥1-point improvement on the LFS2 at day 30. Other endpoints included improvements on the FACE-Q Satisfaction with Lips questionnaire, Global Aesthetic Improvement Scale (GAIS), subject assessment of natural look/feel of lips, and investigator assessment of dynamic lip lines upon animation. Injection site reactions (ISRs) and adverse events (AEs) were recorded. Results: Of 60 subjects enrolled (mean age, 36.8 years; 98.3% female), 59 were evaluable for efficacy at day 30; 13 (21.4%) received touch-up treatment. Thirty-six of 40 subjects completed the extension study (month 12). LFS2 responder rates were 93.2% at day 30 (primary endpoint) and 39.0% at month 12. Mean scores on the FACE-Q questionnaire improved from baseline by 45.2 points and 23.6 points at day 30 and month 12, respectively. Most subjects showed improvements on the GAIS. The majority of ISRs were mild/moderate; no serious AEs occurred. Conclusions: VYC-17.5L was effective and well tolerated for lip augmentation through 12 months posttreatment.

11.
J Clin Med ; 11(4)2022 Feb 21.
Article in English | MEDLINE | ID: mdl-35207413

ABSTRACT

OBJECTIVE: The effect of baseline differences between men and women on early outcomes after percutaneous coronary intervention (PCI). DESIGN, SETTING, PARTICIPANTS: This is an observational study of all participants in the GenesisCare Cardiovascular Outcomes Registry, undergoing PCI. The registry holds data for both emergency and elective procedures. Data was collected on 10,989 consecutive patients from 12 Australian Private Hospitals, including baseline demographics, co-morbidities, risk factors, PCI procedures, and lesion characteristics. MAIN OUTCOME MEASURES: Outcome was measured for complications (in-hospital death, peri-procedural myocardial infarctions, and bleeding events), at discharge and at 30-days for death, myocardial infarction, target lesion revascularisation (TLR), major adverse cardiac events (MACE), and unplanned readmissions. RESULTS: Women represented 23% of the study population, were significantly older, with a higher rate of hypertension and hyperlipidaemia. Heart failure was more common in women and was associated with a significantly higher average ejection fraction than in men. Women had a lower rate of pre-existing coronary artery disease (CAD), had less complex CAD, and needed fewer stents. Periprocedural complications were similar, but major bleeding was more common in women. The 30-day outcome was similar between men and women for death, myocardial infarction, target lesion revascularisation (TLR), major adverse cardiovascular events (MACE), and unplanned readmissions. CONCLUSIONS: Although significant differences were observed between women and men in both clinical presentation and complexity of disease, the 30-day outcome was similar for death and MACE. Women had a higher rate of major bleeding events, and lower adherence to statins and dual antiplatelet therapy (DAPT).

12.
J Clin Med ; 11(22)2022 Nov 21.
Article in English | MEDLINE | ID: mdl-36431346

ABSTRACT

Background and aim: Unplanned cardiac readmissions in patients with percutaneous intervention (PCI) is very common and is seen as a quality indicator of in-hospital care. Most studies have reported on the 30-day cardiac readmission rates, with very limited information being available on 1-year readmission rates and their association with mortality. The aim of this study was to investigate the impact of biological sex at 1-year post-PCI on unplanned cardiac readmissions. Methods and results: Patients enrolled into the GenesisCare Cardiovascular Outcomes Registry (GCOR-PCI) from December 2008 to December 2020 were included in the study. A total of 13,996 patients completed 12 months of follow-up and were assessed for unplanned cardiac readmissions. All patients with unplanned cardiac readmissions in the first year of post-PCI were followed in year 2 (post-PCI) for survival status. The rate of unplanned cardiac readmissions was 10.1%. Women had a 29% higher risk of unplanned cardiac readmission (HR 1.29, 95% CI 1.11 to 1.48; p = 0.001), and female sex was identified as an independent predictor of unplanned cardiac readmissions. Any unplanned cardiac readmission in the first year was associated with a 2.5-fold higher risk of mortality (HR 2.50, 95% CI 1.67 to 3.75; p < 0.001), which was similar for men and women. Conclusion: Unplanned cardiac readmissions in the first year post-PCI was strongly associated with increased all-cause mortality. Whilst the incidence of all-cause mortality was similar between women and men, a higher incidence of unplanned cardiac readmissions was observed for women, suggesting distinct predictors of unplanned cardiac readmissions exist between women and men.

13.
J Clin Med ; 11(17)2022 Sep 05.
Article in English | MEDLINE | ID: mdl-36079161

ABSTRACT

Background and aim: poor quality of life (QoL) has been identified as an independent risk factor for mortality and major cardiac events (MACE) in patients with cardiovascular disease (CVD). The aim of this study was to assess health-related quality of life (HRQoL) at baseline and its association with outcome in patients with coronary artery disease presenting for percutaneous coronary intervention (PCI). The outcome was measured by mortality and MACE at 1-year, and whether there was any difference for sex and different age groups. Methods and results: all patients prospectively enrolled into the GenesisCare Outcome Registry (GCOR) over a 11-year period were included in the study. The EQ-5D-5L and VAS patient survey were used for assessment of baseline HRQoL. Of the 15,198 patients, only 6591 (43.4%) completed the self-assessment. Women had significantly more impairment of all five dimensions of the EQ-5D-5L survey, and their self-reported QoL was significantly lower than men (68.3 in women vs. 71.9 in men, p < 0.001). Poor QoL was strongly associated with increased mortality (HR 2.85; 95% CI 1.76 to 4.62, p < 0.001) and MACE (HR 1.40; 95% CI 1.10 to 1.79, p = 0.01). A similar trend was noted for women and men, but did not reach significance in women due to the smaller number of female patients. Conclusion: poor HRQoL is associated with subsequent mortality and MACE in patients undergoing PCI. By not assessing quality of life as a standard of care, an opportunity is lost to identify high-risk patients who may benefit from targeted interventions to improve health outcomes.

14.
Open Heart ; 9(1)2022 05.
Article in English | MEDLINE | ID: mdl-35534092

ABSTRACT

BACKGROUND: Despite rapid technological advances and growth, quality in imaging has not received the focus seen elsewhere in cardiovascular medicine, resulting in significant gaps between guidelines and practice. Contemporary echocardiography practice requires comprehensive real-time data collection to allow dynamic auditing and benchmarking of key performance indices. The American College of Cardiology (ACC) proposed additional data standardisation, structured reporting identifying key data elements and imaging registries. In the absence of an Australian echocardiography registry, we developed a national clinical quality registry (GenesisCare Cardiovascular Outcomes Echo Registry). We hypothesised that measurement and local reporting of data would improve compliance of echo studies with quality guidelines and hence their clinical value. METHODS AND RESULTS: We prospectively collected data on 4 099 281 echocardiographic studies entered directly into a central electronic database from 63 laboratories across four Australian states between 2010 and 2021. Real-time auditing of key data elements and introduction of quality improvement pathways were performed to maximise completeness and uniformity of data acquisition and reporting. We compared completeness of key data element acquisition (AV peak velocity, left ventricular ejection fraction, E/e', LA area, rhythm, RVSP) by time and state using de-identified data. Key performance outcomes benchmarked against the aggregated study cohort and international standards were reported to individual sites to drive quality improvement. Between 2010 and 2014 there were significant improvements in data completeness (72.0%+/-26.8% vs 86.8%+/-13.5%, p=0.02), which were maintained to 2020. In addition, interstate variability fell for both EF and E/e' (p<0.002). CONCLUSIONS: This large-scale collaboration provides a platform for the development of major quality improvement initiatives in echocardiography. Introduction of local quality assurance programmes via a unified national data set significantly improved the completeness of reporting of key echo quality measures. This in turn significantly improved the quality of, and reduced the interstate variability of, echo data. Developing a centralised database allowed rapid adoption nationally of local quality improvements.


Subject(s)
Echocardiography , Ventricular Function, Left , Australia , Humans , Registries , Stroke Volume , United States
15.
J Clin Med ; 12(1)2022 Dec 29.
Article in English | MEDLINE | ID: mdl-36615080

ABSTRACT

Introduction: Several large registries have evaluated outcomes after percutaneous coronary intervention (PCI) in the USA, however there are no contemporary data regarding long-term outcomes after PCI, particularly comparing new generation drug-eluting stents (DES) with other stents in Australia. Additionally, approval of new-generation drug-eluting stents (DES) is almost exclusively based on non-inferiority trials comparing outcomes with early generation DES, and there are limited data comparing safety and efficacy outcomes of new-generation DES with bare metal stents (BMS). This study reports in-hospital and long-term outcomes after PCI with the Xience DES from a large national registry, the GenesisCare Outcomes Registry (GCOR). Methods: The first 1500 patients consecutively enrolled from January 2015 to January 2019 and treated exclusively with either Xience DES or BMS and eligible for 1-year follow-up were included. Baseline patient and procedural data, major adverse cardiovascular events (MACE) in-hospital, at 30 days and 1-year, and medications were reported and analysed with respect to Xience DES (n = 1000) or BMS (n = 500) use. Results: In this cohort the mean age was 68.4 ± 10.7 years, 76.9% were male, 24.6% had diabetes mellitus and 45.9% presented with acute coronary syndromes. Of the overall cohort of 4765 patients from this period including all DES types, and patients who received multiple DES or a combination of DES and BMS, DES were exclusively used in 3621 (76.0%) patients, and BMS were exclusively used in 596 (12.5%). In comparison to international cohorts, adverse clinical event rates were low at 30 days in terms of mortality (0.20%), target lesion revascularisation (TLR, 0.27%) and MACE (0.47%), and at 12 months for mortality (1.26%) TLR (1.16%) and MACE (1.78%). Conclusions: Clinical practice and long-term outcomes of PCI with the Xience DES in Australia are consistent with international series. Recent trends indicate DES use has increased in parallel with good outcomes despite an increasingly complex patient and lesion cohort.

16.
Catheter Cardiovasc Interv ; 77(2): 217-9, 2011 Feb 01.
Article in English | MEDLINE | ID: mdl-21290555

ABSTRACT

We describe two cases of no reflow phenomenon in the setting of primary PCI for ST elevation myocardial infarction successfully managed with intracoronary vasodilator therapy via a Clearway™ balloon catheter, where vasodilator therapy via the guiding catheter had been ineffective. Traditionally, if not given via the guiding catheter, vasodilators have been administered via an over-the-wire balloon catheter, which can be cumbersome and time consuming. The Clearway catheter is a rapid exchange balloon catheter affording rapid delivery of vasodilators to the distal infarct related artery without risk of loss of wire position. © 2010 Wiley-Liss, Inc.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Catheters , Myocardial Infarction/therapy , Nitroglycerin/administration & dosage , No-Reflow Phenomenon/drug therapy , Vasodilator Agents/administration & dosage , Verapamil/administration & dosage , Aged , Angioplasty, Balloon, Coronary/adverse effects , Coronary Angiography , Drug Administration Routes , Drug Therapy, Combination , Electrocardiography , Female , Humans , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/diagnosis , No-Reflow Phenomenon/diagnosis , No-Reflow Phenomenon/etiology , Treatment Outcome
17.
Circ Cardiovasc Qual Outcomes ; 14(9): e007963, 2021 09.
Article in English | MEDLINE | ID: mdl-34517724

ABSTRACT

BACKGROUND: National cardiac registries are increasingly used for informing health policy, improving the quality and cost-effectiveness of patient care, clinical research, and monitoring the safety of novel treatments. However, the quality of registries is variable. We aimed to assess the characteristics and quality of national cardiac registries across all subspecialties of cardiac care. METHODS: Publications relating to national cardiac registries across six cardiac subspecialty domains were identified by searching MEDLINE and the Google advanced search function with 26 438 citations and 4812 full-text articles reviewed. RESULTS: A total of 155 registries, representing 49 countries, were included in the study. Of these, 45 related to coronary disease or percutaneous coronary intervention, 28 related to devices, arrhythmia, and electrophysiology, 24 related to heart failure, transplant, and mechanical support, 21 related to structural heart disease, 21 related to congenital heart disease, and 16 related to cardiac surgery. Enrollment was procedure-based in 60% and disease-based in 40%. A total of 73.10 million patients were estimated to have been enrolled in cardiac registries. Quality scoring was performed using a validated registry grading system, with registries performing best in the use of explicit variable definitions and worst in assessment of data reliability. Higher quality scores were associated with government funding, mandated enrollment, linkage to other registries, and outcome risk adjustment. Quality scores and number of registries within a country were positively correlated with each other and with measures of national economic output, health expenditure, and urbanization. CONCLUSIONS: There has been remarkable growth in the uptake of national cardiac registries across the last few decades. However, the quality of processes used to ensure data completeness and accuracy remain variable and few countries have integrated registries covering multiple subspecialty domains. Clinicians, funders, and health policymakers should be encouraged to focus on the range, quality, and integration of these registries. Registration: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42020204224.


Subject(s)
Coronary Disease , Heart Failure , Cost-Benefit Analysis , Humans , Registries , Reproducibility of Results
18.
Int J Cardiol Heart Vasc ; 35: 100828, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34235244

ABSTRACT

BACKGROUND: There is uncertainty regarding whether outcomes after Cardiac Implantable Electronic Devices (CIED) differ between women and men. There are no prospectively collected data regarding Australian CIED outcomes. This study aimed to determine whether the characteristics and outcomes of Australian patients undergoing CIED implantation differ by sex. METHODS: We prospectively followed 5,360 patients undergoing CIED implantation between 2015 and 2019 in a large multi-centre Australian registry. Patient characteristics, procedural data, medications and clinical outcomes to 1 year were analysed. RESULTS: The mean age was 76.2 + 11.2 years, and 2022 (37.7%) were female. Women were older than men at device implantation (77.0 ±â€¯11.6 years vs. 75.5 ±â€¯10.9 years, p < 0.001). Most implants were de novo (79.7%). Pacing was more commonly for sick sinus syndrome in women than men (54.4% vs. 47.2%, p < 0.001) and less often for A-V block (28.3% vs. 35.1%, p < 0.001). Adverse events at 30 days were low compared to international cohorts, for mortality (0.06%) and major complications (0.6%). There were no significant sex differences (women vs. men) for death (HR 1.33, 95% CI 0.58-3.13, p = 0.49) or major complications (HR 1.41, 95% 95% CI 0.65-3.03, p = 0.39). At 1-year, there was no difference in major complications or risk-adjusted all-cause mortality (HR 1.05, 95% CI 0.70-1.29, p = 0.77) between women and men. CONCLUSIONS: Clinical practice and 30-day outcomes after CIED implantation in Australia are consistent with international reports. There were no differences in procedural complication rates or clinical outcomes at 1-year between women and men, regardless of age or CIED system implanted.

19.
Am J Cardiol ; 148: 36-43, 2021 06 01.
Article in English | MEDLINE | ID: mdl-33667454

ABSTRACT

There are conflicting data on whether patients with insulin-treated diabetes mellitus (ITDM) have poorer outcomes compared with non-insulin treated diabetic (non-ITDM) patients following percutaneous coronary intervention (PCI). We therefore compared clinical outcomes following PCI in ITDM versus non-ITDM patients. We prospectively collected data on 4,579 patients with diabetes underwent PCI between 2005 and 2014 in a large multicenter registry and dichotomized them as having ITDM (n = 1,111) or non-ITDM (n = 3,468). The non-ITDM group was further divided into diet control only (diet-DM; n = 786) and those taking oral hypoglycemic agents (OHG-DM; n = 2,639), and clinical outcomes were compared with ITDM patients. Median follow-up for long-term mortality was 4.2 years (IQR 2.0 to 6.6 years). ITDM patients were more likely to be female, obese, and have severe renal impairment (all p <0.001). Procedural characteristics were similar other than a greater use of drug-eluting stents in ITDM patients. On multivariable analysis, ITDM was an independent predictor of 12-month major adverse cardiovascular and cerebrovascular events (MACCE; OR 1.26, 95% CI 1.02 to1.55, p = 0.03). Dividing the non-ITDM group further by treatment, a progressively higher rate of 12-month MACCE across the 3 groups was observed (13.5% vs 17.9% vs 21.8%; p <0.001). Long-term mortality was similar in the diet-DM and OHG-DM groups, but significantly higher in the ITDM group on Kaplan-Meier analysis (log-rank p <0.001). In conclusion, there is a clear gradient of adverse outcomes with escalation of therapy from diet control to OHGs to insulin.


Subject(s)
Coronary Artery Disease/surgery , Diabetes Mellitus/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Percutaneous Coronary Intervention , Aged , Angina, Stable/epidemiology , Angina, Stable/surgery , Angina, Unstable/epidemiology , Angina, Unstable/surgery , Atherectomy, Coronary , Comorbidity , Coronary Artery Disease/epidemiology , Diabetes Mellitus/epidemiology , Drug-Eluting Stents , Female , Humans , Male , Middle Aged , Non-ST Elevated Myocardial Infarction/epidemiology , Non-ST Elevated Myocardial Infarction/surgery , Prognosis , ST Elevation Myocardial Infarction/epidemiology , ST Elevation Myocardial Infarction/surgery , Stroke Volume , Ventricular Dysfunction, Left/epidemiology
20.
Clin Cardiol ; 44(7): 1002-1010, 2021 Jul.
Article in English | MEDLINE | ID: mdl-34042199

ABSTRACT

BACKGROUND: The RE-DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y12 inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y12 inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI. HYPOTHESIS: The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males. METHODS: The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint. RESULTS: A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47-1.01, males: HR 0.46, 95% CI 0.37-0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively). CONCLUSIONS: Consistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.


Subject(s)
Atrial Fibrillation , Coronary Artery Disease , Percutaneous Coronary Intervention , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Coronary Artery Disease/drug therapy , Dabigatran/adverse effects , Drug Therapy, Combination , Female , Fibrinolytic Agents/adverse effects , Humans , Male , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Warfarin/adverse effects
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