ABSTRACT
BACKGROUND: Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system. OBJECTIVES: We report 3-year outcomes from the multinational, prospective, single-arm CLASP study with analysis by functional MR (FMR) and degenerative MR (DMR). METHODS: Patients with core-lab determined MR ≥ 3+ were deemed candidates for M-TEER by the local heart team. Major adverse events were assessed by an independent clinical events committee to 1 year and by sites thereafter. Echocardiographic outcomes were evaluated by the core laboratory to 3 years. RESULTS: The study enrolled 124 patients, 69% FMR; 31% DMR (60% NYHA class III-IVa, 100% MR ≥ 3+). The 3-year Kaplan-Meier estimate for survival was 75% (66% FMR; 92% DMR) and freedom from heart failure hospitalization (HFH) was 73% (64% FMR; 91% DMR), with 85% reduction in annualized HFH rate (81% FMR; 96% DMR) (p < 0.001). MR ≤ 2+ was achieved and maintained in 93% of patients (93% FMR; 94% DMR) and MR ≤ 1+ in 70% of patients (71% FMR; 67% DMR) (p < 0.001). The mean left ventricular end-diastolic volume (181 mL at baseline) decreased progressively by 28 mL [p < 0.001]. NYHA class I/II was achieved in 89% of patients (p < 0.001). CONCLUSIONS: The 3-year results from the CLASP study demonstrated favorable and durable outcomes with the PASCAL transcatheter valve repair system in patients with clinically significant MR. These results add to the growing body of evidence establishing the PASCAL system as a valuable therapy for patients with significant symptomatic MR.
Subject(s)
Cardiac Surgical Procedures , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Humans , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Prospective Studies , Treatment OutcomeABSTRACT
OBJECTIVES: We assessed sex differences in treatment and outcomes in ST-segment elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PCI). BACKGROUND: Historically, delays to timely reperfusion and poorer outcomes have been described in women who suffer STEMI. However, whether these sex discrepancies still exist with contemporary STEMI treatment remains to be evaluated. METHODS: Consecutive STEMI patients treated with primary PCI patients over a 10-year period (January 1, 2010 to December 31, 2019) from a tertiary referral center were assessed. Comparisons were performed between patient's sex. Primary outcomes were 30-day and 1-year mortality. Secondary outcomes were STEMI performance measures. RESULTS: Most patients (n = 950; 76%) were male. Females were on average older (66.8 vs. 61.4 years males; p < 0.001). Prehospital treatment delays did not differ between sexes (54 min [IQR: 44-65] females vs. 52 min [IQR: 43-62] males; p = 0.061). STEMI performance measures (door-to-balloon, first medical contact-to-balloon [FMCTB]) differed significantly with longer median durations in females and fewer females achieving FMCTB < 90 min (28% females vs. 39% males; p < 0.001). Women also experienced greater rates of initial radial arterial access failure (11.3% vs. 3.1%; p < 0.001). However, there were no significant sex differences in crude or adjusted mortality between sexes at 30-days (3.6% male vs. 5.1% female; p = 0.241, adjusted OR: 1.1, 95% CI: 0.5-2.2, p = 0.82) or at 1-year (4.8% male vs. 6.8% female; p = 0.190, adjusted OR: 1.0, (95% CI: 0.5-1.8; p = 0.96). CONCLUSION: Small discrepancies between sexes in measures of timely reperfusion for STEMI still exist. No significant sex differences were observed in either 30-day or 1-year mortality.
Subject(s)
Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Female , Humans , Male , Percutaneous Coronary Intervention/adverse effects , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/etiology , ST Elevation Myocardial Infarction/therapy , Sex Characteristics , Time-to-Treatment , Treatment OutcomeABSTRACT
AIMS: This study sought to investigate patient and operator radiation dose in patients undergoing percutaneous coronary intervention (PCI) and the impact of body mass index (BMI) on patient and operator dose. METHODS: In patients undergoing PCI, radiation dose parameters, baseline characteristics and procedural data were collected in a tertiary centre for 3.5 years. Operators wore real time dosimeters. Patients were grouped by BMI. Dose area product (DAP) and operator radiation dose were compared across patient BMI categories. Multivariable analysis was performed to investigate the impact of patient BMI and other procedural variables on patient and operator dose. RESULTS: 2,043 patients underwent 2,197 PCI procedures. Each five-unit increase in BMI increased patient dose (expressed as DAP) by an average 31% (95% CI: 29-33%) and operator dose by 27% (95% CI: 20-33%). Patient dose was 2.3 times higher and operator dose was 2.4 times higher in patients with a BMI>40 than for normal BMI patients. Multivariable analysis indicated that there were many procedural factors that were predictors for increasing operator dose and patient dose but that patient BMI was a major contributor for both operator dose and patient dose. CONCLUSION: Increasing BMI increases the DAP and operator dose for PCI procedures and BMI is demonstrated to be a major factor that contributes to both patient and operator radiation dose.
Subject(s)
Percutaneous Coronary Intervention , Radiation Exposure , Body Mass Index , Coronary Angiography/adverse effects , Humans , Percutaneous Coronary Intervention/methods , Radiation Dosage , Risk FactorsABSTRACT
INTRODUCTION: Pre-hospital activation and direct cardiac catheterisation laboratory (CCL) transfer of ST segment elevation myocardial infarction (STEMI) has previously been shown to improve door-to-balloon (DTB) times yet there is limited outcome data in the Australian context. We aimed to assess the impact of pre-hospital activation on STEMI performance measures and mortality. METHODS: Prospective cohort study of consecutive ambulance transported STEMI patients treated with primary percutaneous coronary intervention (PCI) patients over a 10-year period (1 January 2008-31 December 2017) at The Prince Charles Hospital, a large quaternary referral centre in Brisbane, Queensland Australia. Comparisons were performed between patients who underwent pre-hospital CCL activation and patients who did not. STEMI performance measures, 30-day and 1-year mortality were examined. RESULTS: Amongst 1,009 patients included (mean age: 62.8 yrs±12.6), pre-hospital activation increased over time (26.6% in 2008 to 75.0% in 2017, p<0.001). Median DTB time (35 mins vs 76 mins p<0.001) and percentage meeting targets (DTB<60 mins 92% vs 27%, p<0.001) improved significantly with pre-hospital activation. Pre-hospital activation was associated with significantly lower 30-day (1.0% vs 3.5%, p=0.007) and 1-year (1.2% vs 7.7%, p<0.001) mortality. After adjusting for confounders and mediators, we observed a strong total effect of pre-hospital activation on 1-year mortality (OR 5.3, 95%CI 2.2-12.4, p<0.001) compared to patients who did not have pre-hospital activation. False positive rates were 3.7% with pre-hospital activation. CONCLUSION: In patients who underwent primary PCI for STEMI, pre-hospital activation and direct CCL transfer is associated with low false positive rates, significantly reduced time to reperfusion and lower 30-day and 1-year mortality.
Subject(s)
Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Australia , Cardiac Catheterization , Hospitals , Humans , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/surgery , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: This study sought to investigate the characteristics, morbidity (including the rate of infective endocarditis and valve replacement) and mortality of individuals undergoing percutaneous pulmonary valve implantation in Australia and New Zealand since the procedure has been performed. BACKGROUND: The outcomes of percutaneous pulmonary valve implantation in Australia and New Zealand have not been evaluated. Recent international data, including patients from New Zealand, suggests the rate of infective endocarditis is not insignificant. METHODS: A retrospective multi-site cohort study was undertaken via medical record review at the centres where percutaneous pulmonary valve implantation has been performed. All procedures performed from 2009-March 2018 were included. Individuals were identified from local institution databases. Data was collected and analysed including demographics, details at the time of intervention, haemodynamic outcome, post procedure morbidity and mortality. Multi-site ethics approval was obtained. RESULTS: One hundred and seventy-nine (179) patients attended the cardiac catheter laboratory for planned percutaneous pulmonary valve implantation. Of these patients, 172 underwent successful implantation. Tetralogy of Fallot and pulmonary atresia were the most common diagnoses. The median age at procedure was 19 years (range 3-60 yrs). There was a significant improvement in the acute haemodynamics in patients undergoing percutaneous pulmonary valve implantation for stenosis. Seven (7) patients (3.9%) experienced a major procedural/early post procedure complication (death, conversion to open procedure, cardiac arrest), including two deaths. The annualised rates of infective endocarditis and valve replacement were 4.6% and 3.8% respectively. There was one death related to infective endocarditis in follow-up. CONCLUSIONS: Percutaneous pulmonary valve replacement is a relatively safe method of rehabilitating the right ventricular outflow tract.
Subject(s)
Endocarditis, Bacterial , Endocarditis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pulmonary Valve Insufficiency , Pulmonary Valve , Humans , Child, Preschool , Child , Adolescent , Young Adult , Adult , Middle Aged , Pulmonary Valve/surgery , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis/adverse effects , New Zealand/epidemiology , Retrospective Studies , Cohort Studies , Treatment Outcome , Endocarditis, Bacterial/complications , Pulmonary Valve Insufficiency/epidemiology , Pulmonary Valve Insufficiency/surgery , Endocarditis/epidemiology , Endocarditis/surgery , Cardiac Catheterization/methodsABSTRACT
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a high incidence of cerebrovascular injury. As these injuries are thought to be primarily embolic, neuroprotection strategies have focused on embolic protection devices. However, the topographical distribution of cerebral emboli and how this impacts on the effectiveness of these devices have not been thoroughly assessed. Here, we evaluated the anatomical characteristics of magnetic resonance imaging (MRI)-defined cerebral ischemic lesions occurring secondary to TAVI to enhance our understanding of the distribution of cardioembolic phenomena. METHODS: Forty patients undergoing transfemoral TAVI with an Edwards SAPIEN-XT valve under general anesthesia were enrolled prospectively in this observational study. Participants underwent brain MRI preprocedure, and 3 ± 1 days and 6 ± 1 months postprocedure. RESULTS: Mean ± SD participant age was 82 ± 7 years. Patients had an intermediate to high surgical risk, with a mean Society of Thoracic Surgeons score of 6.3 ± 3.5 and EuroSCORE of 18.1 ± 10.6. Post-TAVI, there were no clinically apparent cerebrovascular events, but MRI assessments identified 83 new lesions across 19 of 31 (61%) participants, with a median ± interquartile range number and volume of 1 ± 2.8 lesions and 20 ± 190 µL per patient. By volume, 80% of the infarcts were cortical, 90% in the posterior circulation and 81% in the right hemisphere. CONCLUSIONS: The distribution of lesions that we detected suggests that cortical gray matter, the posterior circulation, and the right hemisphere are all particularly vulnerable to perioperative cerebrovascular injury. This finding has implications for the use of intraoperative cerebral embolic protection devices, particularly those that leave the left subclavian and, therefore, left vertebral artery unprotected.
Subject(s)
Aortic Valve Stenosis/surgery , Brain , Cerebral Infarction , Intraoperative Complications/prevention & control , Postoperative Complications , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Australia/epidemiology , Brain/diagnostic imaging , Brain/pathology , Cerebral Infarction/diagnosis , Cerebral Infarction/epidemiology , Cerebral Infarction/etiology , Embolic Protection Devices , Female , Humans , Intracranial Embolism/diagnostic imaging , Intracranial Embolism/etiology , Intraoperative Complications/epidemiology , Intraoperative Complications/etiology , Magnetic Resonance Imaging/methods , Male , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methodsABSTRACT
OBJECTIVE: To examine whether there are sex differences in the characteristics, management, and clinical outcomes of patients with an ST-elevation myocardial infarction (STEMI). Design, setting: Cohort study; analysis of data collected prospectively by the CONCORDANCE acute coronary syndrome registry from 41 Australian hospitals between February 2009 and May 2016. PARTICIPANTS: 2898 patients (2183 men, 715 women) with STEMI. MAIN OUTCOME MEASURES: Rates of revascularisation (percutaneous coronary intervention [PCI], thrombolysis, coronary artery bypass grafting [CABG]), adjusted for GRACE risk score quartile. SECONDARY OUTCOMES: timely vascularisation rates; major adverse cardiac event rates; clinical outcomes and preventive treatments at discharge. RESULTS: The mean age of women with STEMI at presentation was 66.6 years (SD, 14.5 years), of men, 60.5 years (SD, 12.5 years). The proportions of women with hypertension, diabetes, prior stroke, chronic kidney disease, chronic heart failure, or dementia were larger than those of men; fewer women had histories of previous coronary artery disease or myocardial infarction, or of prior PCI or CABG. Women were less likely to have undergone coronary angiography (odds ratio, adjusted for GRACE score quartile [aOR], 0.53; 95% CI, 0.41-0.69) or revascularisation (aOR, 0.42; 95% CI, 0.34-0.52); they were less likely to have received timely revascularisation (aOR, 0.72; 95% CI, 0.63-0.83) or primary PCI (aOR, 0.76; 95% CI, 0.61-0.95). Six months after admission, the rates of major adverse cardiovascular events (aOR, 2.68; 95% CI, 1.76-4.09) and mortality (aOR, 2.17; 95% CI, 1.24-3.80) were higher for women. At discharge, significantly fewer women than men received ß-blockers, statins, and referrals to cardiac rehabilitation. CONCLUSION: Women with STEMI are less likely to receive invasive management, revascularisation, or preventive medication at discharge. The reasons for these persistent differences in care require investigation.
Subject(s)
ST Elevation Myocardial Infarction/mortality , ST Elevation Myocardial Infarction/therapy , Aged , Australia/epidemiology , Cohort Studies , Female , Humans , Male , Middle Aged , Risk Factors , ST Elevation Myocardial Infarction/epidemiology , Sex Factors , Treatment OutcomeABSTRACT
In patients with a degenerative mitral bioprosthesis and prohibitive surgical risk there is emerging evidence for the feasibility of valve-in-valve procedures via a percutaneous transvenous transseptal approach. This paper describes the first time this procedure has been performed in Australia.
Subject(s)
Bioprosthesis/adverse effects , Cardiac Catheterization/methods , Heart Valve Prosthesis , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Aged, 80 and over , Animals , Cattle , Echocardiography, Transesophageal , Heart Valve Prosthesis Implantation/methods , Humans , Male , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnosis , Prosthesis Failure , Queensland , ReoperationABSTRACT
BACKGROUND: The association of anaemia with aortic stenosis (AS) has been recognised for over 50 years; however, although there have been several sporadic reports, there are few data on the prevalence of this syndrome. AIMS: We sought to compare the prevalence of anaemia in adults with AS with that of controls who had undergone coronary artery bypass grafting (CABG). METHODS: We conducted a retrospective cohort study comparing pre-procedural levels of haemoglobin in 1537 adults who underwent aortic valve replacement (AVR) for AS with 8025 contemporaneous patients who had CABG. We hypothesised that the prevalence of anaemia in patients with AS would be significantly higher than in the control group. RESULTS: A total of 30.1% in the AVR group was anaemic compared to 16.2% in the CABG group. The mean haemoglobin concentration measured across the whole population was significantly lower (132 g/L) in AVR patients than in those who underwent CABG (138 g/L). In a multivariable model, haemoglobin levels varied significantly by treatment group, gender and age. The adjusted marginal mean haemoglobin value was 135.6 g/L in AVR patients compared to 137.3 g/L in CABG patients. CONCLUSIONS: The prevalence of anaemia was significantly greater in patients with AS than in a contemporaneous cohort that underwent CABG. This may indicate that Heyde syndrome is more common than has been generally appreciated and should be considered in the evaluation of anaemia in patients with AS.
Subject(s)
Anemia/diagnosis , Anemia/epidemiology , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/epidemiology , Gastrointestinal Hemorrhage/diagnosis , Gastrointestinal Hemorrhage/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Anemia/blood , Aortic Valve Stenosis/blood , Cohort Studies , Coronary Artery Bypass/trends , Female , Gastrointestinal Hemorrhage/blood , Humans , Male , Middle Aged , Retrospective Studies , Syndrome , Young AdultABSTRACT
We describe a successful transcatheter, transapical mitral valve implant within a failed mitral bioprosthesis (valve-in-valve) in a symptomatic 86-year-old patient with prohibitive surgical risks, using the new Sapien 3 balloon-expandable valve. Post-deployment echocardiographic profile of the valve-in-valve was satisfactory and the patient was discharged from hospital uneventfully. This is the first reported case of the Sapien 3 valve used in the mitral valve-in-valve setting.
Subject(s)
Heart Valve Prosthesis Implantation/methods , Mitral Valve/surgery , Prosthesis Failure , Aged, 80 and over , Female , Heart Valve Prosthesis , Humans , Mitral Valve/diagnostic imagingABSTRACT
BACKGROUND: Transcatheter pulmonary valve implantation (TPVI) with the Melody® transcatheter pulmonary valve (TPV) has demonstrated good haemodynamic and clinical outcomes in the treatment of right ventricular outflow tract (RVOT) conduit dysfunction in patients with repaired congenital heart disease CHD. We present the first Australian single centre experience of patients treated with Melody TPV. METHOD: A prospective, observational registry was developed to monitor clinical and haemodynamic outcomes in patients with RVOT dysfunction treated with the Melody TPV (Medtronic Inc, Minneapolis, United States). RESULTS: Seventeen patients underwent TPVI with Melody TPV at The Prince Charles Hospital between January 2009 and February 2016 with a median (range) age of 34 (R: 15-60). Fifteen (88%) were NYHA Class 2 dyspnoea and 11 (59%) had corrected Tetralogy of Fallot. Indication for TPVI was stenosis in eight (47%), regurgitation in two (12%) and mixed dysfunction in seven (41%). Device implantation was successful in all patients. Peak RVOT gradient was significantly reduced and there was no significant regurgitation post procedure. There was one (6%) major procedural adverse event and two (12%) major adverse events at last recorded follow-up. There were no patient deaths. Follow-up cardiac magnetic resonance imaging revealed a significant reduction in indexed right ventricular end diastolic volume. CONCLUSION: This study confirms the safety and effectiveness of TPVI with Melody TPV for RVOT dysfunction in repaired CHD.
Subject(s)
Cardiac Catheterization/methods , Heart Valve Prosthesis Implantation/methods , Hemodynamics/physiology , Pulmonary Valve/surgery , Ventricular Outflow Obstruction/surgery , Adolescent , Adult , Echocardiography , Female , Follow-Up Studies , Heart Valve Diseases/complications , Heart Valve Diseases/diagnosis , Heart Valve Diseases/surgery , Humans , Male , Middle Aged , Prospective Studies , Pulmonary Valve/diagnostic imaging , Time Factors , Tomography, X-Ray Computed , Ventricular Outflow Obstruction/complications , Ventricular Outflow Obstruction/physiopathology , Young AdultABSTRACT
OBJECTIVES: The objective of this study is to describe and compare the use of the MitraClip therapy in mitral regurgitation (MR) patients with degenerative MR (DMR) and functional MR (FMR). INTRODUCTION: Percutaneous edge-to-edge repair of severe MR using the MitraClip device is approved for use in the USA for high risk DMR while European guidelines include its use in FMR patients as well. METHODS: The MitraClip in the Asia-Pacific Registry (MARS) is a multicenter retrospective registry, involving eight sites in five Asia-Pacific countries. Clinical and echocardiographic characteristics, procedural outcomes and 1-month outcomes [death and major adverse events (MAE)] were compared between FMR and DMR patients treated with the MitraClip. RESULTS: A total of 163 patients were included from 2011 to 2014. The acute procedural success rates for FMR (95.5%, n = 84) and DMR (92%, n = 69) were similar (P = 0.515). 45% of FMR had ≥2 clips inserted compared to 60% of those with DMR (P = 0.064).The 30-day mortality rate for FMR and DMR was similar at 4.5% and 6.7% respectively (P = 0.555). The 30-day MAE rate was 9.2% for FMR and 14.7% for DMR (P = 0.281). Both FMR and DMR patients had significant improvements in the severity of MR and NYHA class after 30 days. There was a significantly greater reduction in left ventricular end-diastolic diameter (P = 0.002) and end systolic diameter (P = 0.017) in DMR than in FMR. CONCLUSIONS: The MitraClip therapy is a safe and efficacious treatment option for both FMR and DMR. Although, there is a significantly greater reduction in LV volumes in DMR, patients in both groups report clinical benefit with improvement in functional class. © 2015 Wiley Periodicals, Inc.
Subject(s)
Cardiac Catheterization/instrumentation , Mitral Valve Insufficiency/therapy , Mitral Valve , Aged , Aged, 80 and over , Asia , Australia , Cardiac Catheterization/adverse effects , Echocardiography , Female , Hemodynamics , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Recovery of Function , Registries , Retrospective Studies , Stroke Volume , Time Factors , Treatment Outcome , Ventricular Function, LeftABSTRACT
BACKGROUND: People with unstable angina and non-ST elevation myocardial infarction (UA/NSTEMI) are managed with a combination of medical therapy, invasive angiography and revascularisation. Specifically, two approaches have evolved: either a 'routine invasive' strategy whereby all patients undergo coronary angiography shortly after admission and, if indicated, coronary revascularisation; or a 'selective invasive' (also referred to as 'conservative') strategy in which medical therapy alone is used initially, with a selection of patients for angiography based upon evidence of persistent myocardial ischaemia. Uncertainty exists as to which strategy provides the best outcomes for these patients. This Cochrane review is an update of a Cochrane review originally published in 2006, to provide a robust comparison of these two strategies in the early management of patients with UA/NSTEMI. OBJECTIVES: To determine the benefits and harms associated with the following.1. A routine invasive versus a conservative or 'selective invasive' strategy for the management of UA/NSTEMI in the stent era.2. A routine invasive strategy with and without glycoprotein IIb/IIIa receptor antagonists versus a conservative strategy for the management of UA/NSTEMI in the stent era. SEARCH METHODS: We searched the following databases and additional resources up to 25 August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, MEDLINE and EMBASE, with no language restrictions. SELECTION CRITERIA: We included prospective randomised controlled trials (RCTs) that compared invasive with conservative or 'selective invasive' strategies in participants with acute UA/NSTEMI. DATA COLLECTION AND ANALYSIS: Two review authors screened the records and extracted data in duplicate. Using intention-to-treat analysis with random-effects models, we calculated summary estimates of the risk ratio (RR) with 95% confidence intervals (CIs) for the primary endpoints of all-cause death, fatal and non-fatal myocardial infarction (MI), combined all-cause death or non-fatal MI, refractory angina and re-hospitalisation. We performed further analysis of included studies based on whether glycoprotein IIb/IIIa receptor antagonists were used routinely. We assessed the heterogeneity of included trials using Pearson χ² (Chi² test) and variance (I² statistic) analysis. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, we assessed the quality of the evidence and the GRADE profiler (GRADEPRO) was used to import data from Review Manager 5.3 (Review Manager) to create Summary of findings (SoF) tables. MAIN RESULTS: Eight RCTs with a total of 8915 participants (4545 invasive strategies, 4370 conservative strategies) were eligible for inclusion. We included three new studies and 1099 additional participants in this review update. In the all-study analysis, evidence did not show appreciable risk reductions in all-cause mortality (RR 0.87, 95% CI 0.64 to 1.18; eight studies, 8915 participants; low quality evidence) and death or non-fatal MI (RR 0.93, 95% CI 0.71 to 1.2; seven studies, 7715 participants; low quality evidence) with invasive strategies compared to conservative (selective invasive) strategies at six to 12 months follow-up. There was appreciable risk reduction in MI (RR 0.79, 95% CI 0.63 to 1.00; eight studies, 8915 participants; moderate quality evidence), refractory angina (RR 0.64, 95% CI 0.52 to 0.79; five studies, 8287 participants; moderate quality evidence) and re-hospitalisation (RR 0.77, 95% CI 0.63 to 0.94; six studies, 6921 participants; moderate quality evidence) with routine invasive strategies compared to conservative (selective invasive) strategies also at six to 12 months follow-up.Evidence also showed increased risks in bleeding (RR 1.73, 95% CI 1.30 to 2.31; six studies, 7584 participants; moderate quality evidence) and procedure-related MI (RR 1.87, 95% CI 1.47 to 2.37; five studies, 6380 participants; moderate quality evidence) with routine invasive strategies compared to conservative (selective invasive) strategies.The low quality evidence were as a result of serious risk of bias and imprecision in the estimate of effect while moderate quality evidence was only due to serious risk of bias. AUTHORS' CONCLUSIONS: In the all-study analysis, the evidence failed to show appreciable benefit with routine invasive strategies for unstable angina and non-ST elevation MI compared to conservative strategies in all-cause mortality and death or non-fatal MI at six to 12 months. There was evidence of risk reduction in MI, refractory angina and re-hospitalisation with routine invasive strategies compared to conservative (selective invasive) strategies at six to 12 months follow-up. However, routine invasive strategies were associated with a relatively high risk (almost double the risk) of procedure-related MI, and increased risk of bleeding complications. This systematic analysis of published RCTs supports the conclusion that, in patients with UA/NSTEMI, a selectively invasive (conservative) strategy based on clinical risk for recurrent events is the preferred management strategy.
Subject(s)
Angina, Unstable/therapy , Angioplasty, Balloon, Coronary/adverse effects , Myocardial Infarction/therapy , Angina, Unstable/mortality , Angina, Unstable/surgery , Cause of Death , Coronary Angiography , Coronary Artery Disease/therapy , Female , Humans , Male , Myocardial Infarction/mortality , Myocardial Infarction/surgery , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Randomized Controlled Trials as Topic , Sex Factors , StentsABSTRACT
BACKGROUND: The efficacy of second-generation drug-eluting stents (DES) in treating in-stent restenosis (ISR) compared to first-generation DES and non-DES treatment methods in real-world cohorts has not yet been adequately addressed. This research intends to examine optimum treatment of in-stent restenosis, considering first-generation DES, second-generation DES and non-DES treatment methods in a real-world cohort. METHODS: Retrospective analysis was performed on 114 patients treated for native-vessel BMS or DES ISR. Thirty-two were treated with a first-generation DES (81% sirolimus, 19% paclitaxel), 32 with a second-generation DES (72% everolimus, 28% zotarolimus) and 28 with non-DES methods (32% bare-metal stent, 39% balloon angioplasty, 29% cutting balloon). The composite primary endpoint was total adverse cardiac events, recurrent stable angina, unstable angina, myocardial infarction (MI), target vessel revascularisation (TVR) and cardiac death at minimum clinical follow-up of six months. RESULTS: Primary endpoint rates were significantly higher in the non-DES and second-generation DES treatment groups than in first-generation DES (42.9%, 25.9%, 6.2%; p=0.004). Rates of MI and TVR were significantly higher in the non-DES treatment group, compared to first and second-generation DES (MI: 17.9%, 0%, 5.6%; p=0.018; TLR: 21.4%, 3.1%, 7.4%; p=0.041). CONCLUSIONS: First-generation DES may be superior to second-generation DES and non-DES in treating BMS or DES ISR with regard to overall adverse cardiac events.
Subject(s)
Angina, Stable/etiology , Drug-Eluting Stents/adverse effects , Everolimus/administration & dosage , Graft Occlusion, Vascular/prevention & control , Myocardial Infarction/etiology , Sirolimus/analogs & derivatives , Aged , Female , Follow-Up Studies , Graft Occlusion, Vascular/physiopathology , Humans , Male , Middle Aged , Retrospective Studies , Sirolimus/administration & dosageABSTRACT
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.
Subject(s)
Acute Kidney Injury/mortality , Postoperative Complications/mortality , Transcatheter Aortic Valve Replacement/adverse effects , Acute Kidney Injury/blood , Acute Kidney Injury/etiology , Aged, 80 and over , Creatinine/blood , Female , Humans , Male , Postoperative Complications/blood , Risk FactorsABSTRACT
Pericardiocentesis is an important diagnostic and therapeutic technique, with the potential for significant morbidity and mortality if performed incorrectly. This article attempts to cover the anatomy, preparation, and techniques necessary to successfully perform pericardiocentesis.
Subject(s)
Cardiac Catheterization/methods , Cardiac Tamponade/therapy , Pericardial Effusion/therapy , Pericardiocentesis/methods , Ultrasonography, Doppler , Cardiac Tamponade/diagnostic imaging , Drainage/methods , Female , Humans , Male , Pericardial Effusion/diagnostic imagingABSTRACT
BACKGROUND: Although numerous studies have reported the safety and effectiveness of transcatheter aortic valve implantation (TAVI), integration of this therapy into standard of care varies widely by region. We evaluated mid-term follow-up in 540 patients with severe symptomatic AS at high risk of surgical AV replacement, enrolled in the ongoing Medtronic CoreValve Australia-New Zealand Study. METHODS: Between August 2008 and July 2013, 10 centres in Australia/New Zealand enrolled 540 patients, which includes initial use of the CoreValve System for all investigators. Patients were deemed suitable for TAVI based on consensus of a multidisciplinary Heart Team. Primary endpoints were cardiovascular death and major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days. Data were fully monitored, and an independent Clinical Events Committee employed. RESULTS: Baseline characteristics include; 45% female, mean age 84 years, EuroSCORE 17.3±10.7%, and 74.9% had New York Heart Association III/IV symptoms. At 30 days, all deaths were cardiovascular (4.1%); MACCE was 11.5%. At one and two years, all-cause mortality was 11.9% and 21.2%; cardiovascular mortality, 9.9% and 15.2%; and stroke, 8.2% and 10.1%, respectively. CONCLUSIONS: Early experience with the CoreValve System in a large cohort of fully-monitored patients was associated with good early- and mid-term safety outcomes.
Subject(s)
Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Australia/epidemiology , Female , Follow-Up Studies , Humans , Male , New Zealand , Risk Factors , Stroke/etiology , Stroke/mortality , Transcatheter Aortic Valve Replacement/adverse effectsABSTRACT
The Cardiac Society of Australia and New Zealand (CSANZ) and the Australia and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) have joined together to provide recommendations for institutions and individual operators to assess their ability to initiate and maintain a transcatheter valve program. Transcatheter aortic valve replacement has been developed as an alternative to traditional surgical replacement of the aortic valve in high risk patients, particularly the frail elderly. The position paper has endorsed the important role of a multi-disciplinary "Heart Team" in selecting patients for TAVI as fundamental to the establishment of a successful program. The paper outlines recommendations for the cardiologist to have a background in structural intervention and the surgeon to have experience in high-risk aortic valve replacement. It is further recommended that TAVI programs be established in high volume cardiac surgical centres where on site valve surgery is performed. The paper is intended to provide guidance to individual operators and prospective institutions considering the establishment of a successful TAVI program.
Subject(s)
Societies, Medical , Thoracic Surgery , Transcatheter Aortic Valve Replacement/standards , Australia , Humans , New Zealand , Practice Guidelines as TopicABSTRACT
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.
Subject(s)
Blood Vessel Prosthesis Implantation/adverse effects , Cardiac Catheterization/instrumentation , Cardiopulmonary Bypass , Graft Occlusion, Vascular/therapy , Heart Defects, Congenital/surgery , Stents , Collateral Circulation , Constriction, Pathologic , Female , Graft Occlusion, Vascular/diagnosis , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/physiopathology , Heart Defects, Congenital/diagnosis , Heart Defects, Congenital/physiopathology , Hemodynamics , Humans , Middle Aged , Pulmonary Circulation , Tomography, X-Ray Computed , Treatment Outcome , Ultrasonography, Interventional , Vascular PatencyABSTRACT
OBJECTIVES: The aim of this study was to compare the long-term outcomes of transcoronary ablation of septal hypertrophy (TASH) with open surgical myomectomy (SM) in patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM). METHODS: We reviewed patients who underwent either procedure at our institution. The demographics, clinical outcomes, echocardiographic parameters, and complications were compared. RESULTS: Seventy patients with HOCM were treated with either TASH (n = 47, 26 male) or SM (n = 23, 10 male). Compared to those treated with SM, patients undergoing TASH were older (57+/- 14.7 years versus 47 +/- 20.6 years, P = 0.021) and more symptomatic. A higher proportion of patients had syncope as a presenting feature in the TASH group compared to the SM group (57.5% vs. 17.4%, P = 0.002) respectively. They were also more likely to be in New York Heart Association (NYHA) class III/IV compared to the patients who underwent SM (85.1% vs. 39.1%; P < 0.001). Patients were followed for a mean period of 43 months (TASH) and 46 months (SM). Repeat procedures were more common in the TASH group (17% vs. 0%, P = 0.04) but mitral valve replacement was more common in the SM group (0% vs. 8.7%, P = 0.105). Symptom improvement, the rate of complications and all cause mortality rates were similar in both groups. CONCLUSIONS: TASH compares favorably with surgical myectomy with regard to symptom resolution, rate of complications and mortality in a tertiary referral centre and should be seen as an attractive alternative to surgical myectomy in the appropriate patient population.