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1.
Am J Cardiol ; 203: 429-435, 2023 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-37536045

RESUMO

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.


Assuntos
Exposição Ocupacional , Exposição à Radiação , Proteção Radiológica , Humanos , Cateteres Cardíacos , Exposição Ocupacional/prevenção & controle , Doses de Radiação , Exposição à Radiação/prevenção & controle
2.
J Am Heart Assoc ; 12(14): e029346, 2023 07 18.
Artigo em Inglês | MEDLINE | ID: mdl-37449585

RESUMO

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.


Assuntos
Angioplastia Coronária com Balão , Serviços Médicos de Emergência , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Eletrocardiografia , Cateterismo Cardíaco
3.
Catheter Cardiovasc Interv ; 102(1): 145-154, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37178388

RESUMO

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.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do Tratamento
4.
Heart Lung Circ ; 31(12): 1649-1657, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36038469

RESUMO

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.


Assuntos
Endocardite Bacteriana , Endocardite , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar , Valva Pulmonar , Humanos , Pré-Escolar , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Valva Pulmonar/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas/efeitos adversos , Nova Zelândia/epidemiologia , Estudos Retrospectivos , Estudos de Coortes , Resultado do Tratamento , Endocardite Bacteriana/complicações , Insuficiência da Valva Pulmonar/epidemiologia , Insuficiência da Valva Pulmonar/cirurgia , Endocardite/epidemiologia , Endocardite/cirurgia , Cateterismo Cardíaco/métodos
5.
Catheter Cardiovasc Interv ; 100(4): 520-529, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35971748

RESUMO

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.


Assuntos
Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Feminino , Humanos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Caracteres Sexuais , Tempo para o Tratamento , Resultado do Tratamento
6.
Heart Lung Circ ; 31(7): 974-984, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35227611

RESUMO

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.


Assuntos
Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Austrália , Cateterismo Cardíaco , Hospitais , Humanos , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Fatores de Tempo , Resultado do Tratamento
7.
Heart Lung Circ ; 31(3): 372-382, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34654649

RESUMO

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.


Assuntos
Intervenção Coronária Percutânea , Exposição à Radiação , Índice de Massa Corporal , Angiografia Coronária/efeitos adversos , Humanos , Intervenção Coronária Percutânea/métodos , Doses de Radiação , Fatores de Risco
8.
PLoS One ; 16(10): e0259148, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34699549

RESUMO

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).


Assuntos
Antitrombinas/uso terapêutico , Heparina/uso terapêutico , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Idoso , Feminino , Hirudinas , Humanos , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes/uso terapêutico , Terapia Trombolítica , Resultado do Tratamento
9.
Eur Cardiol ; 16: e25, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34163538

RESUMO

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.

10.
JACC Cardiovasc Interv ; 14(14): 1538-1548, 2021 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-34020928

RESUMO

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.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Idoso , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do Tratamento
11.
JACC Cardiovasc Interv ; 13(20): 2344-2357, 2020 10 26.
Artigo em Inglês | MEDLINE | ID: mdl-33092709

RESUMO

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).


Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Idoso , Humanos , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do Tratamento
13.
JACC Cardiovasc Interv ; 12(14): 1369-1378, 2019 07 22.
Artigo em Inglês | MEDLINE | ID: mdl-31255562

RESUMO

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).


Assuntos
Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Tolerância ao Exercício , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Hemodinâmica , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Qualidade de Vida , Recuperação de Função Fisiológica , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda
14.
J Med Radiat Sci ; 66(1): 20-29, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30488575

RESUMO

INTRODUCTION: Diagnostic coronary angiography (CA) uses ionising radiation with relatively high doses, which impact on both patients and staff. This study sought to identify which patient and procedural factors impact patient and operator dose the most during CA. METHODS: Patient and procedure related variables impacting on Kerma area product (PKA ) and operator dose (OD) were collected for 16 months. Procedures were separated into 10 different procedure categories. PKA was used for patient dose and OD was measured with an instantly downloadable dosimeter (IDD) - downloaded at the end of each procedure. High and low radiation dose was defined by binary variables based on the 75th percentile of the continuous measures. Univariate and multivariate regression were used to identify predictors. RESULTS: Of 3860 patients included, the IDD was worn for 2591 (61.7%). Obesity (BMI > 30 compared to BMI < 25) was the strongest predictor for both a PKA (odds ratio (OR) = 19.1 (95% CI 13.5-26.9) P < 0.001) and OD (OR = 3.3 (2.4-4.4) P < 0.001) above the 75th percentile. Male gender, biplane imaging, the X-ray unit used, operator experience and procedure type also predicted a high PKA . Radial access, male gender, biplane imaging and procedure type also predicted a high OD. CONCLUSION: Radiation dose during CA is multifactorial and is dependent on patient and procedure related variables. Many factors impact on both PKA and OD but obesity is the strongest predictor for both patients and operators to receive a high radiation dose.


Assuntos
Angiografia Coronária , Exposição Ocupacional/análise , Doses de Radiação , Exposição à Radiação/análise , Idoso , Angiografia Coronária/efeitos adversos , Feminino , Humanos , Masculino , Proteção Radiológica , Estudos Retrospectivos
15.
Am J Cardiol ; 123(6): 956-960, 2019 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-30594290

RESUMO

Transcatheter aortic valve implantation (TAVI) is an effective therapeutic option for severe symptomatic aortic valve stenosis (AS) with intermediate or high surgical risk. The purpose of this study was to examine the effects of TAVI on left ventricular (LV) mechanics using multilayer global longitudinal strain (GLS) by 2D speckle-tracking echocardiography. A total of 119 patients (mean age 83 ± 7.0 years, male 54%) with severe symptomatic AS and normal LV ejection fraction (LVEF) underwent echocardiography at baseline and 1 month after TAVI. Global longitudinal strain was measured from the endocardial layer (GLSendo), mid-ventricular layer (GLSmyo), epicardial layer (GLSepi) and full thickness of myocardium (GLSwhole). There was significant improvement in all 3 layers of GLS after TAVI compared with baseline, but there was no significant change in LVEF. The relative % increment in GLS in each layer strain were 11.2 ± 23.4% (GLSendo), 13.4 ± 33.0% (GLSmyo) and 18.0 ± 46.6% (GLSepi) with significant difference between GLSendo and GLSepi (p < 0.05). In conclusion, multilayer GLS is more sensitive than conventional LVEF to detect early improvement in LV systolic function after TAVI in patients with severe AS. There is a disproportional improvement in different layers with least improvement in the endocardium. Multilayer strain analysis may provide new insights into understanding mechanics of AS.


Assuntos
Estenose da Valva Aórtica/cirurgia , Ecocardiografia/métodos , Ventrículos do Coração/fisiopatologia , Volume Sistólico/fisiologia , Substituição da Valva Aórtica Transcateter/métodos , Função Ventricular Esquerda/fisiologia , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Feminino , Seguimentos , Ventrículos do Coração/diagnóstico por imagem , Humanos , Masculino , Estudos Retrospectivos , Sístole , Resultado do Tratamento
16.
Int J Cardiol Heart Vasc ; 20: 46-49, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30148201

RESUMO

BACKGROUND: It was hypothesized that the accuracy of coronary CT angiography would be affected by case volume of the referring sites. METHODS: The positive predictive value (PPV) of CTCA performed at a tertiary hospital specialising in cardiothoracic medicine and services with lower case-volumes were calculated. The tertiary hospital used as the high case-volume reference centre was The Prince Charles Hospital, which performed >1500 CTCA scans per annum over the study period. The low case-volume services used in the study were suburban radiology services, each with <500 cases per year. The PPV of positive CTCA at the reference site was compared to the pooled PPV of all other sites as a combined cohort, using invasive angiography as the reference standard. 512 scans were included, n = 199 subjects in the reference centre cohort, and n = 311 subjects in the pooled community radiology practice cohort. RESULTS: The positive predictive value (PPV) of the high case-volume group (n = 199) was 0.7538. The PPV of the pooled low case-volume services (n = 589) was 0.7331, p = 0.604, with no statistically significant difference in positive predictive values. CONCLUSIONS: There was no significant difference in PPV between the two groups. This suggests that high-volume and lower-volume sites both have high PPV in Australia, above the published pooled PPV of four large prospective diagnostic accuracy studies (Miller et al., 2008; Budoff et al., 2008; Meijboom et al., 2008; Achenbach, 2007).

18.
Med J Aust ; 209(3): 118-123, 2018 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-30025513

RESUMO

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.


Assuntos
Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Idoso , Austrália/epidemiologia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Fatores Sexuais , Resultado do Tratamento
19.
J Am Coll Cardiol ; 71(11): 1246-1254, 2018 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-29544609

RESUMO

BACKGROUND: Transesophageal echocardiography operators (TEEOP) provide critical imaging support for percutaneous structural cardiac intervention procedures. They stand close to the patient and the associated scattered radiation. OBJECTIVES: This study sought to investigate TEEOP radiation dose during percutaneous structural cardiac intervention. METHODS: Key personnel (TEEOP, anesthetist, primary operator [OP1], and secondary operator) wore instantly downloadable personal dosimeters during procedures requiring TEE support. TEEOP effective dose (E) and E per unit Kerma area product (E/KAP) were calculated. E/KAP was compared with C-arm projections. Additional shielding for TEEOP was implemented, and doses were measured for a further 50 procedures. Multivariate linear regression was performed to investigate independent predictors of radiation dose reduction. RESULTS: In the initial 98 procedures, median TEEOP E was 2.62 µSv (interquartile range [IQR]: 0.95 to 4.76 µSv), similar to OP1 E: 1.91 µSv (IQR: 0.48 to 3.81 µSv) (p = 0.101), but significantly higher than secondary operator E: 0.48 µSv (IQR: 0.00 to 1.91 µSv) (p < 0.001) and anesthetist E: 0.48 µSv (IQR: 0.00 to 1.43 µSv) (p < 0.001). Procedures using predominantly right anterior oblique (RAO) and steep RAO projections were associated with high TEEOP E/KAP (p = 0.041). In a further 50 procedures, with additional TEEOP shielding, TEEOP E was reduced by 82% (2.62 µSv [IQR: 0.95 to 4.76] to 0.48 µSv [IQR: 0.00 to 1.43 µSv] [p < 0.001]). Multivariate regression demonstrated shielding, procedure type, and KAP as independent predictors of TEEOP dose. CONCLUSION: TEE operators are exposed to a radiation dose that is at least as high as that of OP1 during percutaneous cardiac intervention. Doses were higher with procedures using predominantly RAO projections. Radiation doses can be significantly reduced with the use of an additional ceiling-suspended lead shield.


Assuntos
Ecocardiografia Transesofagiana , Exposição Ocupacional , Intervenção Coronária Percutânea/métodos , Exposição à Radiação , Proteção Radiológica/métodos , Austrália , Ecocardiografia Transesofagiana/efeitos adversos , Ecocardiografia Transesofagiana/métodos , Feminino , Humanos , Masculino , Exposição Ocupacional/análise , Exposição Ocupacional/prevenção & controle , Avaliação de Resultados em Cuidados de Saúde , Doses de Radiação , Exposição à Radiação/análise , Exposição à Radiação/prevenção & controle
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