Long-Term Valve Durability in Patients Undergoing Transcatheter Aortic Valve Implantation.

AIMS: To evaluate the long-term incidence of structural valve deterioration (SVD) in patients who underwent transcatheter aortic valve implantation (TAVI). METHOD AND RESULTS: Between 2008 and 2018, 693 underwent TAVI at two centres. Four hundred and twenty-one (421) patients (mean age 83.6±6.0 yrs) survived for ≥2 years post TAVI and had at least two consecutive transthoracic echocardiographies (TTEs) with the latest TTE no less than 2 years after TAVI, and were therefore included in the analysis for SVD. Median follow-up was 4.7 (3.6-6.0) years and median echocardiography follow-up 3 (3.0-4.0) years. All-cause mortality was 30.9% (130) with a median time to death of 4.1 (3.0-5.6) years. The cumulative incidence of SVD increased from 1.7% (95% CI, 0.4-2.9) at 3 years to 3.5% (95% CI, 1.5-5.8) at 5 years and 4.7% (95% CI, 1.6-7.9) at 10 years. The overall median time to SVD was 3 (2-4) years. Twelve (12) patients demonstrated SVD stage 2, and 1 patient stage 3. No SVD required re-intervention. All other patients showed no significant changes in valve parameters over time. CONCLUSIONS: Structural valve deterioration is an uncommon event, occurring in 5% over a total follow-up of 10 years. Most patients show stable valve parameters. However, the analysis is limited by the loss of follow-up (owing to patient mortality), which renders extrapolation of the data to a younger patient population difficult.

Sex differences in treatment and outcomes of patients with in-hospital ST-elevation myocardial infarction.

BACKGROUND AND HYPOTHESIS: Two cohorts face high mortality after ST-elevation myocardial infarction (STEMI): females and patients with in-hospital STEMI. The aim of this study was to evaluate sex differences in ischemic times and outcomes of in-hospital STEMI patients. METHODS: Consecutive STEMI patients treated with percutaneous coronary intervention (PCI) were prospectively recruited from 30 hospitals into the Victorian Cardiac Outcomes Registry (2013-2018). Sex discrepancies within in-hospital STEMIs were compared with out-of-hospital STEMIs. The primary endpoint was 12-month all-cause mortality. Secondary endpoints included symptom-to-device (STD) time and 30-day major adverse cardiovascular events (MACE). To investigate the relationship between sex and 12-month mortality for in-hospital versus out-of-hospital STEMIs, an interaction analysis was included in the multivariable models. RESULTS: A total of 7493 STEMI patients underwent PCI of which 494 (6.6%) occurred in-hospital. In-hospital versus out-of-hospital STEMIs comprised 31.9% and 19.9% females, respectively. Female in-hospital STEMIs were older (69.5 vs. 65.9 years, p = .003) with longer adjusted geometric mean STD times (104.6 vs. 94.3 min, p < .001) than men. Female versus male in-hospital STEMIs had no difference in 12-month mortality (27.1% vs. 20.3%, p = .92) and MACE (22.8% vs. 19.3%, p = .87). Female sex was not independently associated with 12-month mortality for in-hospital STEMIs which was consistent across the STEMI cohort (OR: 1.26, 95% CI: 0.94-1.70, p = .13). CONCLUSIONS: In-hospital STEMIs are more frequent in females relative to out-of-hospital STEMIs. Despite already being under medical care, females with in-hospital STEMIs experienced a 10-min mean excess in STD time compared with males, after adjustment for confounders. Adjusted 12-month mortality and MACE were similar to males.

Differences in outcomes of patients with in-hospital versus out-of-hospital ST-elevation myocardial infarction: a registry analysis.

OBJECTIVES: Patients with ST-elevation myocardial infarction (STEMI) that occur while already in hospital ('in-hospital STEMI') face high mortality. However, data about this patient population are scarce. We sought to investigate differences in reperfusion and outcomes of in-hospital versus out-of-hospital STEMI. DESIGN, SETTING AND PARTICIPANTS: Consecutive patients with STEMI all treated with percutaneous coronary intervention (PCI) across 30 centres were prospectively recruited into the Victorian Cardiac Outcomes Registry (2013-2018). PRIMARY AND SECONDARY OUTCOMES: Patients with in-hospital STEMI were compared with patients with out-of-hospital STEMI with a primary endpoint of 30-day major adverse cardiovascular events (MACE). Secondary endpoints included ischaemic times, all-cause mortality and major bleeding. RESULTS: Of 7493 patients with PCI-treated STEMI, 494 (6.6%) occurred in-hospital. Patients with in-hospital STEMI were older (67.1 vs 62.4 years, p<0.001), more often women (32% vs 19.9%, p<0.001), with more comorbidities. Patients with in-hospital STEMI had higher 30-day MACE (20.4% vs 9.8%, p<0.001), mortality (12.1% vs 6.9%, p<0.001) and major bleeding (4.9% vs 2.3%, p<0.001), than patients with out-of-hospital STEMI. According to guideline criteria, patients with in-hospital STEMI achieved symptom-to-device times of ≤70 min and ≤90 min in 29% and 47%, respectively. Patients with out-of-hospital STEMI achieved door-to-device times of ≤90 min in 71%. Occurrence of STEMI while in hospital independently predicted higher MACE (adjusted OR 1.77, 95% CI 1.33 to 2.36, p<0.001) and 12-month mortality (adjusted OR 1.49, 95% CI 1.08 to 2.07, p<0.001). CONCLUSIONS: Patients with in-hospital STEMI experience delays to reperfusion with significantly higher MACE and mortality, compared with patients with out-of-hospital STEMI, after adjustment for confounders. Focused strategies are needed to improve recognition and outcomes in this high-risk and understudied population.

SMARTphone Based Cardiovascular Risk Reduction in BREAST Cancer Patients (SMART-BREAST): A Randomised Controlled Trial Protocol.

INTRODUCTION: Breast cancer survivors are at greater risk for cardiovascular-related mortality compared to women without breast cancer. Accordingly, attention to reducing the risk of cardiovascular disease must be a priority in the long-term management of these patients. With the exponential rise in cancer survivors, there is a need for innovative cardio-oncology programs. This paper describes the study design of a randomised controlled trial assessing the effectiveness of a smartphone-based cardiovascular risk reduction program in improving physical activity and cardiovascular health in patients undergoing treatment for breast cancer. METHODS AND ANALYSIS: The aim of this study is to assess the efficacy and usability of a smartphone-based model of care for exercise promotion, cardiovascular risk reduction and community engagement in women undergoing treatment for breast cancer. This will be achieved by testing our personalised smartphone application "BreastMate", as an adjunct to standard care in a single-blinded, parallel, randomised controlled trial. The primary outcome of the trial is change in exercise capacity, as measured by the 6-minute walk test distance at 12 months compared to baseline. Secondary endpoints include improvements in cardiovascular risk factor status and quality of life, received dose intensity of chemotherapy and major adverse cardiovascular events. ETHICS: Multicentre ethical approval has been granted by the Austin Hospital (HREC/47081/Austin/2018). DISSEMINATION OF RESULTS: The analysed results will be published in a peer reviewed journal on completion of the clinical trial. REGISTRATION DETAILS: SMART-BREAST has been prospectively registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR12620000007932).

Long-Term Outcomes Stratified by Body Mass Index in Patients Undergoing Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) is emerging as the default strategy for older patients with severe, symptomatic, and trileaflet aortic stenosis. Increased body-mass index (BMI) is associated with a protective effect in patients undergoing percutaneous coronary intervention. We assessed whether elevated BMI was associated with a similar association in TAVI. We evaluated prospectively collected data from 634 patients who underwent TAVI at 2 centers from August 2008 to April 2019. Patients were stratified as normal weight (BMI 18.5 to 24.9 kg/m2, n = 214), overweight (25 to 29.9 kg/m2, n = 234), and obese (>30 kg/m2, n = 185). Outcomes were reported according to VARC-2 criteria. Mortality was assessed using Cox proportional hazards regression analysis (median follow-up 2 years). Kaplan-Meier analysis was used to estimate cumulative mortality. Baseline differences were seen in age (85 vs 84 vs 82, p <0.001), STS-PROM score (4.3 vs 3.4 vs 3.6, p <0.001), sex (50% vs 36% vs 55% female, p <0.001), clinical frailty score (p = 0.02), diabetes (21% vs 29% vs 40%, p <0.001), and presence of chronic obstructive pulmonary disease (COPD) (13% vs 13% vs 23%, p = 0.009). On multivariable analysis there was no mortality difference between normal and obese patients (hazard ratio [HR] 0.70, confidence interval [CI] 0.46 to 1.1 p = 0.11), however overweight patients had significantly lower mortality (HR 0.56 CI 0.38 to 0.85, p = 0.006). Variables independently associated with increased mortality were increasing age, male sex, COPD, previous balloon valvuloplasty, and higher STS-PROM. In conclusion, overweight patients have lower long-term mortality when compared with normal weight and obese patients undergoing TAVI.

Comparison of Early Outcomes in Patients at Estimated Low, Intermediate and High Risk Undergoing Transcatheter Aortic Valve Implantation: A Multicentre Australian Experience.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been shown to be a safe and effective alternative to surgical aortic valve replacement (SAVR) in high- and intermediate-risk patients with severe aortic stenosis. TAVI for patients at lower risk of periprocedural mortality has not been extensively investigated. We aimed to describe outcomes in low-, intermediate- and high-risk patients undergoing TAVI in a multicentre Australian study. METHODS: We evaluated data from 601 patients who underwent TAVI at two hospitals in Melbourne, from August 2008 to February 2018. Patients were stratified according to low risk (STS <4%), intermediate risk (Society for Thoracic Surgeons [STS] 4.0-7.9%) and high risk (STS >8%). Outcomes were reported according to Valve Academic Research Consortium-2 (VARC-2) criteria. RESULTS: Mean age was 84±5 years and 49% were female. Two hundred and eighty-five (285) (47%) patients were low-risk, 243 (40%) were intermediate risk and 73 (12%) were high risk. Thirty-day (30-) mortality was low in all three groups (1.1%, 1.7% and 1.4%, respectively, p=0.8). Similarly, patients had a low risk of disabling stroke (0.4%, 1.3%, 0%, p=0.8). Rates of post-procedural permanent pacemaker were also similar (21%, 27%, 26%, p=0.5). At least moderate aortic regurgitation occurred in 9% of patients at discharge with no significant differences between groups. CONCLUSIONS: In this large Australian multicentre cohort of TAVI patients, 30-day mortality, and post-procedural outcomes were excellent and similar across the patient-risk spectrum. Our study offers further support for the safety of TAVI in low-risk populations and demonstrates the limitations of the STS score.

Comparison of Outcomes of Transcatheter Aortic Valve Implantation in Patients Aged >90 Years Versus <90 Years.

Limited data exist regarding transcatheter aortic valve implantation (TAVI) in nonagenarians. This study evaluates the short- and mid-term outcomes of nonagenarians after TAVI. Between 2008 and 2017, all patients who underwent TAVI in 2 centers in Australia were prospectively included in a registry and followed-up for 5 years. Outcomes were based on VARC-2 criteria. Additionally, the patient's reliance on daily living support at 1 year was evaluated. Of the 588 patients, 71 (12.1%) were ≥90 years old (mean age 92.2 ± 2 vs 83.2 ± 6 years in <90-year-old patients), with a median STS-PROM score of 5.7 (vs 3.9 in <90-year-old patients, odds ratio [OR] 1.07, 95% confidence interval 1.01 to 1.13, p = 0.02) and a median clinical frailty score of 4 (vs 4 <90-year-old patients, OR 0.88, p = 0.44). Mortality was 0% in ≥90-year-old patients at 30 days (vs 1.4% in <90-year-old patients; p = 0.82) and 12% at 1 year (vs 7.4%, in <90-year-old patients; hazard ratio 1.64, p = 0.20). There were no significant differences in periprocedural complications and mortality at 5 years between the 2 groups. At 1 year, nonagenarians were significantly more likely to live in an aged-care facility compared with <90-year-old patients (25% vs 16%, OR 5.99, 95% confidence interval 2.62 to 13.67, p <0.001). In conclusion, carefully selected nonagenarians have excellent short- and mid-term outcomes post-TAVI and should therefore not be refused based on age alone. Nevertheless, the significantly higher rate of transfer to an aged-care facility highlights the importance of a more refined frailty assessment before TAVI than the currently widely used clinical frailty score.

Current practices of Asia-Pacific cardiologists in the utilization of bioresorbable scaffolds.

BACKGROUND & AIMS: Although Absorb Bioresorbable Vascular Scaffolds (A-BVS) are routinely used in the Asia-Pacific, there is little information on patient selection or deployment technique here. This document investigates the experiences of leading interventional cardiologists from the Asia-Pacific region with a focus on patient characteristics, deployment techniques and management. METHODS AND RESULTS: A detailed questionnaire was distributed to 28 highly-experienced interventional cardiologists ('Authors') from 13 Asia-Pacific countries. The results were discussed at a meeting on patient selection, technical consideration, deployment practices and patient management. Potential patient benefits of Absorb compared to metallic DES, the learning curve for patient selection and preparation, device deployment, and subsequent patient management approaches are presented. CONCLUSIONS: Current practices are derived from guidelines optimized for European patients. Differences in approach exist in the Asia-Pacific context, including limited access to imaging and frequency of occurrence of complex lesions. Nevertheless, the use of the Absorb BVS ('Absorb') in certain Asia-Pacific countries has flourished and practices here are continuing to mature.

Percutaneous coronary intervention in very elderly patients. In-hospital mortality and clinical outcome.

BACKGROUND: There are very few data about percutaneous coronary intervention (PCI) in very elderly patients. This study was aimed at assessing the demographic, clinical and angiographic features, procedural characteristics and in-hospital results of very elderly patients (VEP), aged ≥85 years undergoing PCI and comparing their results with those of a control group (CG) of patients younger than 85 years undergoing PCI throughout the same period of time. METHODS AND RESULTS: Between November 2004 and January 2007, 1699 consecutive PCI procedures were evaluated, 102 (6%) PCI procedures were performed in VEP and 1597 (94%) in patients <85 years. The mean age in the VEP group was 87.4 ± 2.4 years vs. 66.7 ± 11.2 years in the CG (p<0.0001). There were more females in the VEP group 49% vs. 22% than in the CG p<0.0001. Acute coronary syndromes (ACS) were a more frequent indication for PCI in VEP than in the CG: ST segment elevation myocardial infarction (STEMI) 14.7% vs. 8.3%, p = 0.025 and non-ST segment elevation acute coronary syndromes 54.9% vs. 43.5%, p = 0.024. The proportion of drug-eluting stents used, although high in both groups, was lower in VEP than in the CG (86.5% vs. 92.9%, p = 0.005). Angiographic lesion success rates were similar in both groups (95.9%). Global unadjusted in-hospital mortality was higher in the VEP group in comparison with the CG 3.9% vs. 0.68%, p = 0.01. The difference in mortality was due only to PCI in patients presenting with STEMI (26.6% in VEP group vs. 3.7% in the CG p = 0.007). There were no in-hospital deaths in VEP presenting with stable coronary syndromes or other ACS. There were no differences in unadjusted in-hospital myocardial infarction, new revascularisation or stroke between both groups. CONCLUSIONS: In patients ≥85 years old, PCI seems effective and carries an acceptable in-hospital mortality rate. The presence of STEMI substantially increases the risk of in-hospital death.

Randomized trial comparing 600- with 300-mg loading dose of clopidogrel in patients with non-ST elevation acute coronary syndrome undergoing percutaneous coronary intervention: results of the Platelet Responsiveness to Aspirin and Clopidogrel and Troponin Increment after Coronary intervention in Acute coronary Lesions (PRACTICAL) Trial.

BACKGROUND: There is uncertainty about the benefit of a higher loading dose (LD) of clopidogrel in patients with non-ST elevation acute coronary syndrome (NSTEACS) undergoing early percutaneous coronary intervention (PCI). METHODS: We compared the effects of a 600- versus a 300-mg LD of clopidogrel on inhibition of platelet aggregation, myonecrosis, and clinical outcomes in patients with NSTEACS undergoing an early invasive management strategy. Patients with NSTEACS (n = 256, mean age 63 years, 81.6% elevated troponin) without thienopyridine for at least 7 days were randomized to receive 600- or 300-mg LD of clopidogrel. Percutaneous coronary intervention was performed in 140 patients, with glycoprotein IIb/IIIa inhibitor use in 68.6%. Adenosine diphosphate (ADP)-induced platelet aggregation was measured by optical platelet aggregometry immediately before coronary angiography. RESULTS: Post-PCI myonecrosis was defined as a next-day troponin I greater than 5 times the upper limit of reference range and greater than baseline levels. Clopidogrel 600-mg LD compared with 300-mg LD was associated with significantly reduced ADP-induced platelet aggregation (49.7% vs 55.7% with ADP 20 micromol/L) but did not reduce post-PCI myonecrosis or adverse clinical outcomes to 6 months. There was no association between preprocedural platelet aggregation and outcome. CONCLUSIONS: These data confirm a modest incremental antiplatelet effect of a 600-mg clopidogrel LD compared with 300-mg LD but provide no support for a clinical benefit in patients with NSTEACS managed with an early invasive strategy including a high rate (69%) of glycoprotein IIb/IIIa inhibitor use during PCI.

Aortic balloon valvuloplasty--review and case series.

Aortic balloon valvuloplasty (BAV) was initially devised in the 1980s as an alternative procedure to the surgical treatment of aortic stenosis, with the theory behind it being both minimally invasive as well as having a lower complication rate [Hara H, et al. Percutaneous balloon aortic valvuloplasty revisited: time for a renaissance? Circulation 2007 March;115(12):e334-8]. In practice however, the procedure was found to have a higher complication rate with only a modest haemodynamic improvement compared to the surgical approach. Most important of all it had an unacceptably high restenosis rate as a substitute for surgery [Otto CM, et al. 3-year outcome after balloon aortic balloon valvuloplasty: insights into prognosis of valvular aortic stenosis. Circulation 1994;89:642-50]. As a result, the procedure has fallen out of favour and has been abandoned at many health care facilities [Hara H, et al. Percutaneous balloon aortic valvuloplasty revisited: time for a renaissance? Circulation 2007 March;115(12):e334-8]. This article will review the management of patients with severe aortic stenosis that are unsuitable to undergo surgery.

Epworth Hospital interventional cardiology audit for 2007.

The cardiac catheterisation laboratory interventional audit for 2007 showed that 761 cases were performed, treating at total of 941 lesions. Unstable coronary syndromes accounted for 59% of all cases. Coronary stenting was performed in 93.3% of cases, with drug-eluting stents being utilised 88% of the time. Adjunctive therapies included intra-aortic balloon pumping in 3.1% of cases, & 19.5% of patients received a glycoprotein IIb/IIIa inhibitor. Procedural success was attained in 96.1% of cases, with an overall mortality rate of 0.53%, and a similar 0.53% of patients proceeded to surgical revascularisation in the same admission.

Percutaneous saphenous vein graft intervention--a review.

Re-do coronary artery bypass graft (CABG) surgery carries significant risk to the patient and existing patent internal thoracic artery grafts. Stenting stenotic saphenous vein grafts (SVGs) with drug-eluting stents (DES) using embolic protection devices (EPDs) is therefore probably the optimum treatment. However, this is fraught with challenges such as distal embolisation and restenosis which may result in peri-procedural myocardial infarction and target vessel failure, respectively. This review focuses on the nature of SVG disease, percutaneous intervention utilising embolic protection and future directions aimed at combating the disappointingly high procedural complication rate and long-term recurrence in this group.