Trial of a Novel Radiation Shielding Device to Protect Staff in the Cardiac Catheter Laboratory.

Continuous exposure to low-level scattered radiation to staff performing cardiac angiography and intervention is of concern. A novel shielding solution (NSS) (Rampart IC M1128) has the potential to provide greater shielding for staff present at the table-side. This study aimed to investigate the effectiveness of the NSS compared with a traditional shielding solution (TSS) in a randomized controlled trial that enrolled 100 patients who underwent cardiac angiography and/or intervention which were randomized to the NSS or TSS. Baseline patient characteristics and radiation dose data were collected. Staff who were scrubbed at the table-side wore 5 real-time dosimeters on the head, collar, waist, ankle, and under the apron. The median primary operator radiation dose was significantly lower (p <0.001) for all dosimeter locations with the NSS when compared with the TSS, being reduced by 86%, 80.0%, 100%, and 50.0% for the head, collar, waist, and leg respectively. Median under-apron dose was 0.0 µSv for both NSS and TSS. Median second operator dose was reduced by 100%, 100%, and 100% for the head, collar, and waist respectively (p <0.001). Median NSS and TSS dose at the ankle and under apron was 0.0 µSv. Median scrub nurse dose was reduced by 50% and 100% for the head and collar respectively (p <0.001). Median NSS and TSS dose at the waist, ankle, and under apron was 0.0 µSv. In conclusion, the NSS tested in this study demonstrates a significant decrease in radiation dose to operators and scrub nurses when compared with traditional radiation protection measures.

Prehospital Activation of the Cardiac Catheterization Laboratory in ST-Segment-Elevation Myocardial Infarction for Primary Percutaneous Coronary Intervention.

Background Prehospital activation of the cardiac catheter laboratory is associated with significant improvements in ST-segment-elevation myocardial infarction (STEMI) performance measures. However, there are equivocal data, particularly within Australia, regarding its influence on mortality. We assessed the association of prehospital activation on performance measures and mortality in patients with STEMI treated with primary percutaneous coronary intervention from the Queensland Cardiac Outcomes Registry (QCOR). Methods and Results Consecutive ambulance-transported patients with STEMI treated with primary percutaneous coronary intervention were analyzed from January 1, 2017 to December 31, 2020 from the QCOR. The total and direct effects of prehospital activation on the primary outcomes (30-day and 1-year cardiovascular mortality) were estimated using logistic regression analyses. Secondary outcomes were STEMI performance measures. Among 2498 patients (mean age: 62.2±12.4 years; 79.2% male), 73% underwent prehospital activation. Median door-to-balloon time (34 minutes [26-46] versus 86 minutes [68-113]; P<0.001), first-electrocardiograph-to-balloon time (83.5 minutes [72-98] versus 109 minutes [81-139]; P<0.001), and proportion of patients meeting STEMI targets (door-to-balloon <60 minutes 90% versus 16%; P<0.001), electrocardiograph-to-balloon time <90 minutes (62% versus 33%; P<0.001) were significantly improved with prehospital activation. Prehospital activation was associated with significantly lower 30-day (1.6% versus 6.6%; P<0.001) and 1-year cardiovascular mortality (2.9% versus 9.5%; P<0.001). After adjustment, no prehospital activation was strongly associated with increased 30-day (odds ratio [OR], 3.6 [95% CI, 2.2-6.0], P<0.001) and 1-year cardiovascular mortality (OR, 3.0 [95% CI, 2.0-4.6]; P<0.001). Conclusions Prehospital activation of cardiac catheterization laboratory for primary percutaneous coronary intervention was associated with significantly shorter time to reperfusion, achievement of STEMI performance measures, and lower 30-day and 1-year cardiovascular mortality.

Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study.

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.

Ten Years of Percutaneous Pulmonary Valve Implantation in Australia and New Zealand.

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.

Sex differences in time to primary percutaneous coronary intervention and outcomes in patients presenting with ST-segment elevation myocardial infarction.

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.

Clinical Outcomes in Pre-Hospital Activation and Direct Cardiac Catheterisation Laboratory Transfer of STEMI for Primary PCI.

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.

Impact of Patient BMI on Patient and Operator Radiation Dose During Percutaneous Coronary Intervention.

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.

Reperfusion After Fibrinolytic Therapy (RAFT): An open-label, multi-centre, randomised controlled trial of bivalirudin versus heparin in rescue percutaneous coronary intervention.

BACKGROUND: The safety and efficacy profile of bivalirudin has not been examined in a randomised controlled trial of patients undergoing rescue PCI. OBJECTIVES: We conducted an open-label, multi-centre, randomised controlled trial to compare bivalirudin with heparin ± glycoprotein IIb/IIIa inhibitors (GPIs) in patients undergoing rescue PCI. METHODS: Between 2010-2015, we randomly assigned 83 patients undergoing rescue PCI to bivalirudin (n = 42) or heparin ± GPIs (n = 41). The primary safety endpoint was any ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) bleeding at 90 days. The primary efficacy endpoint was infarct size measured by peak troponin levels as a multiple of the local upper reference limit (Tn/URL). Secondary endpoints included periprocedural change in haemoglobin adjusted for red cells transfused, TIMI (Thrombolysis in Myocardial Infarction) bleeding, ST-segment recovery and infarct size determined by the Selvester QRS score. RESULTS: The trial was terminated due to slow recruitment and futility after an interim analysis of 83 patients. The primary safety endpoint occurred in 6 (14%) patients in the bivalirudin group (4.8% GPIs) and 3 (7.3%) in the heparin ± GPIs group (54% GPIs) (risk ratio, 1.95, 95% confidence interval [CI], 0.52-7.3, P = 0.48). Infarct size was similar between the two groups (mean Tn/URL, 730 [±675] for bivalirudin, versus 984 [±1585] for heparin ± GPIs, difference, 254, 95% CI, -283-794, P = 0.86). There was a smaller decrease in the periprocedural haemoglobin level with bivalirudin than heparin ± GPIs (-7.5% [±15] versus -14% [±17], difference, -6.5%, 95% CI, -0.83-14, P = 0.0067). The rate of complete (≥70%) ST-segment recovery post-PCI was higher in patients randomised to heparin ± GPIs compared with bivalirudin. CONCLUSIONS: Whether bivalirudin compared with heparin ± GPI reduces bleeding in rescue PCI could not be determined. Slow recruitment and futility in the context of lower-than-expected bleeding event rates led to the termination of this trial (ANZCTR.org.au, ACTRN12610000152022).

2021 CSANZ and ANZSCTS Position Statement on the Operator and Institutional Requirements for a Transcatheter Aortic Valve Implantation (TAVI) Program in Australia.

This document establishes the minimum standard for accreditation of institutions and operators as endorsed by the Cardiac Society of Australia and New Zealand (CSANZ) and the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS). The original Joint Society Position Statement was ratified in August 2014. This 2021 update replaces the original and serves as a consensus within which the Conjoint Committee for Trancatheter Aortic Valve Implantation (TAVI) Accreditation will function, as recommended by Medical Services Advisory Committee (MSAC) Determination for TAVI. This is not a Guideline Statement but takes into consideration regional, legislative, and health system factors important to establishing requirements for TAVI accreditation in Australia.

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

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

Asian Pacific Society of Cardiology Consensus Recommendations on the Use of MitraClip for Mitral Regurgitation.

Transcatheter mitral valve repair with the MitraClip, a catheter-based percutaneous edge-to-edge repair technique to correct mitral regurgitation (MR), has been demonstrated in Western studies to be an effective and safe MR treatment strategy. However, randomised clinical trial data on its use in Asian-Pacific patients is limited. Hence, the Asian Pacific Society of Cardiology convened an expert panel to review the available literature on MitraClip and to develop consensus recommendations to guide clinicians in the region. The panel developed statements on the use of MitraClip for the management of degenerative MR, functional MR, and other less common indications, such as acute MR, dynamic MR, hypertrophic obstructive cardiomyopathy, and MR after failed surgical repair. Each statement was voted on by each panel member and consensus was reached when 80% of experts voted 'agree' or 'neutral'. This consensus-building process resulted in 10 consensus recommendations to guide general cardiologists in the evaluation and management of patients in whom MitraClip treatment is being contemplated.

2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

OBJECTIVES: This study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.

1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

OBJECTIVES: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). BACKGROUND: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. METHODS: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. RESULTS: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). CONCLUSIONS: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

Impacto del acceso vascular en el pronóstico tras la angioplastia coronaria en pacientes con alto riesgo hemorrágico: subanálisis predefinido del estudio LEADERS FREE / Impact of vascular access on outcome after PCI in patients at high bleeding risk: a pre-specified sub-analysis of the LEADERS FREE trial

INTRODUCCIÓN Y OBJETIVOS: El objetivo es evaluar el impacto del acceso vascular en las complicaciones hemorrágicas tras una intervención coronaria percutánea en pacientes con alto riesgo de sangrado (ARS) a los 30 días y a los 2 años. MÉTODOS: El presente estudio es un subanálisis predefinido del estudio LEADERS FREE, que incluyó a 2.432 pacientes con ARS y en el que el stent farmacoactivo Biolimus A9 resultó superior al stent convencional en seguridad y eficacia. RESULTADOS: El acceso radial (AR) se utilizó en 1.454 pacientes (59,8%) y el femoral (AF), en 978 (40,2%), ambos a elección del operador. La seguridad y los beneficios del stent farmacoactivo sobre el convencional fueron independientes del acceso vascular. A los 30 días y a los 2 años, habían sufrido un sangrado mayor el 2,4 y el 7,5% de los pacientes con AR y el 4,6 y el 10,9% de los pacientes con AF (p = 0,003), la mayoría en ambos grupos (el 2,1 y el 7,0% del de AR; el 3,2 y el 9,4% del de AF) no relacionados con el sitio de acceso vascular. El AR se asoció con una reducción significativa en las tasas ajustadas de sangrado mayor tanto a 30 días (HR=1,98; IC95%, 1,25-3,11; p = 0,003) como a 2 años de seguimiento (HR=1,51; IC95%, 1,14-2,01; p = 0,003). CONCLUSIONES: Los operadores prefirieron el AR en la mayoría de los pacientes con ARS, lo cual se asoció con una reducción significativa del sangrado mayor. Asimismo, un número significativo de sangrados en el seguimiento de esta población son no relacionados con el acceso vascular

INTRODUCTION AND OBJECTIVES: The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up. METHODS: The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial. RESULTS: Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was driven by both access and nonaccess bleeding. CONCLUSIONS: Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access

Primary operator radiation dose in the cardiac catheter laboratory.

OBJECTIVES: Radiation from cardiac angiography procedures is harmful to patients and the staff performing them. This study sought to investigate operator radiation dose for a range of procedures and different operators in order to investigate trends and optimise dose. METHODS: Real-time dosemeters (RTDs) were worn by operators for angiography procedures for 3 years. Dose-area product (DAP) and RTD were collected. RTD was normalised to DAP (RTD/DAP) to compare radiation dose and radiation protection measures. Comparisons were made across procedure categories and individual operators. RESULTS: In 7626 procedures, median and 75th percentile levels were established for operator dose for 8 procedure categories. There was a significant difference in all operator dose measures and DAP across procedure categories (p<0.001). DAP, RTD, and RTD/DAP were significantly different across 22 individual operators (p<0.001). CONCLUSION: DAP was significantly different across procedure categories and a higher RTD was seen with higher DAP. RTD/DAP can demonstrate radiation protection effectiveness and identified differences between procedures and individual operators with this measure. Procedures and individuals were identified where further optimisation of radiation protection measures may be beneficial. A reference level for operator dose can be created and audited against on a regular basis. ADVANCES IN KNOWLEDGE: This study demonstrates that operator dose can be easily and routinely measured on a case by case basis to investigate dose trends for different procedures. Normalising the operator dose to DAP demonstrates radiation protection effectiveness for the individual operator which can then be optimised as part of an ongoing audit program.

Impact of vascular access on outcome after PCI in patients at high bleeding risk: a pre-specified sub-analysis of the LEADERS FREE trial.

INTRODUCTION AND OBJECTIVES: The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up. METHODS: The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial. RESULTS: Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was driven by both access and nonaccess bleeding. CONCLUSIONS: Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access.

Impact of vascular access on outcome after PCI in patients at high bleeding risk: a pre-specified sub-analysis of the LEADERS FREE trial

INTRODUCTION AND OBJECTIVES: The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up. METHODS: The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial. RESULTS: Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was driven by both access and nonaccess bleeding. CONCLUSIONS: Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access. (AU)

Three-dimensional printed cardiac fistulae: a case series.

BACKGROUND: Three-dimensional (3D) printing of cardiac fistulae allows for immediate understanding of their complex courses and anatomical relations. Models can be used to improve patient understanding, enhance the consenting process, facilitate communication between multidisciplinary staff at heart team meetings, and help plan surgical or percutaneous interventions. CASE SUMMARY: We report four cases where 3D printed models were used as an adjunct with traditional measures in treating patients with complex cardiac fistulae. DISCUSSION: In our cases, overall patient understanding was improved, staff at heart team meetings were more aware of anatomical anomalies and perioperatively planning saw adjustments made that may have ultimately benefited patient outcome. Our cases highlight the additional benefit that 3D printed models can play when treating patients with complex cardiac fistulae.

Corrigendum to "Coronary CT in Australia has high positive predictive value unaffected by site volume: An analysis of 510 positive CTCA scans with invasive angiographic correlation" [IJC Heart Vasc. 20 (2018) 46-49].

[This corrects the article DOI: 10.1016/j.ijcha.2018.03.005.].

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study.

OBJECTIVES: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).