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"Dagan, Misha"
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Impact of Gender on Transcatheter Aortic Valve Implantation Outcomes
by
Duffy, Stephen J.
,
Crawford, Claudia
,
Htun, Nay M.
in
Activities of daily living
,
Aorta
,
Aortic valve
2020
Previous studies indicate that women who underwentwho underwent transcatheter aortic valve implantation (TAVI) have poorer 30-day outcomes compared with men. However, the effect of gender as a prognostic factor for long-term outcomes following TAVI remains unclear. Between 2008 and 2018, all patients (n = 683) who underwent TAVI in 2 centres in Melbourne, Australia were prospectively included in a registry. The primary end-point was long-term mortality. The secondary end points were Valve Academic Research Consortium-2 (VARC-2) in-hospital complications and mortality at 30-days and 1-year. Of 683 patients, 328 (48%) were women. Women had a higher mean STS-PROM score (5.2 ± 3.1 vs 4.6 ± 3.5, p < 0.001) but less co-morbidities than men. Women had a significantly higher in-hospital bleeding rates (3.3% vs 1.0%, Odds Ratio 4.21, 95% confidence interval [CI] 1.16 to15.25, p = 0.027) and higher 30-day mortality (2.4% vs 0.3%, hazard ratio [HR] 8.75, 95% CI 1.09 to 69.6, p = 0.040) than men. Other VARC-2 outcomes were similar between genders. Overall mortality rate was 36% (246) over a median follow up of 2.7 (interquartile rang [IQR] 1.7 to 4.2) years. Median time to death was 5.3 (95% CI 4.7 to 5.7) years. One-year mortality was similar between genders (8.3% vs 7.8%), as was long-term mortality (HR = 0.91, 95% CI 0.71 to 1.17, p = 0.38). On multivariable analysis, female gender was an independent predictor for 1-year mortality (HR = 2.33, 95% CI 1.11 to 4.92, p = 0.026), but not long-term mortality (HR = 0.78, 95% CI 0.54 to 1.14, p = 0.20). In the women only cohort, STS-PROM was the only independent predictor of long-term mortality (HR 1.88, 95% CI 1.42 to 2.48, p < 0.001). In conclusion, women had higher rates of peri-procedural major bleeding and 30-day mortality following TAVI. However, long-term outcomes were similar between genders.
Journal Article
Differences in outcomes of patients with in-hospital versus out-of-hospital ST-elevation myocardial infarction: a registry analysis
2022
ObjectivesPatients 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 ParticipantsConsecutive 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 outcomesPatients 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.ResultsOf 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).ConclusionsPatients 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.
Journal Article
Application and Performance of CT-Fractional Flow Reserve in Non-ST-Segment Elevation Myocardial Infarction
2025
•The performance of CT-fractional flow reserve (CT-FFR) has not been previously evaluated in patients presenting with low-moderate risk NSTEMI.•In this study, CT-FFR provided additive diagnostic accuracy to coronary computed tomography angiography (CCTA) and demonstrated good correlation with invasive FFR.•CT-FFR may be a suitable gatekeeper to ICA in low-intermediate risk NSTEMI patients, especially in regional or remote settings.•Larger, multi-center studies are required to validate the use of CT-FFR in patients with NSTEMI.
Only half of patients with non-ST-segment elevation myocardial infarction (NSTEMI) have obstructive coronary artery disease (CAD) on invasive coronary angiography (ICA). A non-invasive test that can safely rule out obstructive CAD therefore warrants investigation. Computed tomography fractional flow reserve (CT-FFR) enables hemodynamic interrogation of lesions identified on coronary computed tomography angiography (CCTA) but it has not been evaluated in NSTEMI. Inpatients with NSTEMI were recruited to undergo CCTA with CT-FFR prior to ICA. Blinded CT-FFR was performed using Siemens Frontiers cFFR, version 1.4. Invasive FFR was performed on all intermediate lesions with stenoses measuring >30% to <90%. The performance of CT-FFR and CTCA was compared to the gold-standard of ICA plus FFR. Forty patients (131 vessels) were included. The mean age was 61 ± 11 years and 75% were male. CT-FFR showed good correlation with invasive FFR (r = 0.78) and exhibited excellent diagnostic accuracy for obstructive CAD (defined as FFR<0.80 or angiographic stenosis >90%) on a per-vessel analysis, with a sensitivity of 87%, specificity 99%, positive predictive value (PPV) 97%, negative predictive value (NPV) 95% and area under the receiver operating curve (AUC) 0.93, which was superior to CCTA alone (sensitivity 82%, specificity 92%, PPV 82%, NPV 92%, AUC 0.87, p-value for AUC comparison = 0.04). On a per-patient analysis, CT-FFR had a diagnostic accuracy of 100%. In conclusion, CT-FFR provides additive diagnostic accuracy to CCTA in evaluating patients with NSTEMI and exhibits good correlation with invasive FFR.
Journal Article
Coronary Artery Disease Risk Prediction in Patients With Severe Aortic Stenosis: Development and Validation of the Aortic Stenosis-Coronary Artery Disease (AS-CAD) Score
2023
•The current gold standard invasive coronary angiography in patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation workup is associated with peri-procedural risks and high healthcare expenditure.•We developed and validated AS–coronary artery disease score, a coronary artery disease risk prediction tool specific to patients with severe AS, to identify patients who could be triaged to undergo noninvasive computed tomography coronary assessment.•The application of AS–coronary artery disease in clinical practice could potentially reduce the need for invasive coronary angiography and associated risks and health care costs by up to 43% in the workup for transcatheter aortic valve implantation.
Patients at a low risk of coronary artery disease (CAD) could be triaged to noninvasive coronary computed tomography angiogram instead of invasive coronary angiography, reducing health care costs and patient morbidity. Therefore, we aimed to develop a CAD risk prediction score to identify those who underwent transcatheter aortic valve implantation (TAVI) at a low risk of CAD. We enrolled 1,782 patients who underwent TAVI and randomized the patients to the derivation or validation cohort 2:1. The aortic stenosis–CAD (AS-CAD) score was developed using logistic regression, followed by separation into low- (score 0 to 5), intermediate- (6 to 10), or high-risk (>11) categories. The AS-CAD was validated initially through the k-fold cross-validation, followed by a separately held validation cohort. The average age of the cohort was 82 ± 7 years, and 41% (730 of 1,782) were female; 35% (630) had CAD. The male sex, previous percutaneous coronary intervention, stroke, peripheral arterial disease, diabetes, smoking status, left ventricular ejection fraction <50%, and right ventricular systolic pressure >35 mm Hg were all associated with an increased risk of CAD and were included in the final AS-CAD model (all p <0.03). Within the validation cohort, the AS-CAD score stratified those into low, intermediate, and high risk of CAD (p <0.001). Discrimination was good within the internal validation cohort, with a c-statistic of 0.79 (95% confidence interval 0.74 to 0.84), with similar power obtained using k-fold cross-validation (c-statistic 0.74 [95% confidence interval 0.70 to 0.77]). In conclusion, The AS-CAD score robustly identified those at a low risk of CAD in patients with severe AS. The use of AS-CAD in practice could avoid potential complications of invasive coronary angiogram by triaging low-risk patients to noninvasive coronary assessment using existing computed tomography data.
Journal Article
Trends in Intra-Aortic Balloon Pump Use in Cardiogenic Shock After the SHOCK-II Trial
by
Duffy, Stephen J.
,
Ajani, Andrew E.
,
Dagan, Misha
in
Aorta
,
Balloon treatment
,
Blood pressure
2023
Myocardial infarction complicated by cardiogenic shock (MI-CS) has a poor prognosis, even with early revascularization. Previously, intra-aortic balloon pump (IABP) use was thought to improve outcomes, but the IABP-SHOCK-II (Intra-aortic Balloon Pump in Cardiogenic Shock-II study) trial found no survival benefit. We aimed to determine the trends in IABP use in patients who underwent percutaneous intervention over time. Data were taken from patients in the Melbourne Interventional Group registry (2005 to 2018) with MI-CS who underwent percutaneous intervention. The primary outcome was the trend in IABP use over time. The secondary outcomes included 30-day mortality and major adverse cardiovascular and cerebrovascular events (MACCEs). Of the 1,110 patients with MI-CS, IABP was used in 478 patients (43%). IABP was used more in patients with left main/left anterior descending culprit lesions (62% vs 46%), lower ejection fraction (<35%; 18% vs 11%), and preprocedural inotrope use (81% vs 73%, all p <0.05). IABP use was associated with higher bleeding (18% vs 13%) and 30-day MACCE (58% vs 51%, both p <0.05). The rate of MI-CS per year increased over time; however, after 2012, there was a decrease in IABP use (p <0.001). IABP use was a predictor of 30-day MACCE (odds ratio 1.6, 95% confidence interval 1.18 to 2.29, p = 0.003). However, IABP was not associated with in-hospital, 30-day, or long-term mortality (45% vs 47%, p = 0.44; 46% vs 50%, p = 0.25; 60% vs 62%, p = 0.39). In conclusion, IABP was not associated with reduced short- or long-term mortality and was associated with increased short-term adverse events. IABP use is decreasing but is predominately used in sicker patients with greater myocardium at risk.
Journal Article
Outcomes After Percutaneous Coronary Intervention in Patients With Previous Coronary Artery Bypass Grafting
2025
In patients with previous coronary artery bypass graft surgery (CABG) requiring subsequent percutaneous coronary intervention (PCI), there is uncertainty whether bypass grafts or native coronary arteries should be targeted. We analyzed data from 2,764 patients with previous CABG in the Melbourne Interventional Group registry (2005 to 2018), divided into 2 groups: those who underwent PCI in a native vessel (n = 1,928) and those with PCI in a graft vessel (n = 836). Patients with a graft vessel PCI were older, had more high-risk clinical characteristics (previous myocardial infarction, heart failure, ejection fraction <50%, renal impairment, peripheral and cerebrovascular disease), and had high-risk procedural features (American College of Cardiology and American Heart Association types B2/C lesions). However, patients in the native vessel group were more likely to have PCI in chronic total occlusions. The majority of graft PCI were in saphenous vein grafts (84%), with 10% to radial and 6% in left/right internal mammary artery grafts. Distal embolic protection devices were used in 30% of graft PCI. Patients with graft PCI had higher rates of no reflow (6.3 vs 1.5%, p <0.001), coronary perforation (p = 0.02), and inpatient stent thrombosis (p = 0.03). However, the 30-day mortality and major adverse cardiovascular and cerebrovascular events were similar. The unadjusted long-term mortality (median follow-up of 4.8 years) was higher in patients who underwent a graft PCI (44 vs 32%, p <0.001); however, after Cox proportional hazards modeling, PCI vessel type was not a predictor of long-term mortality (hazard ratio 1.13, 95% confidence interval 0.96 to 1.33, p = 0.14). In conclusion, early clinical outcomes and risk-adjusted long-term mortality are similar for patients with previous CABG who underwent PCI in a native vessel or a bypass graft.
Journal Article
Sex differences in treatment and outcomes of patients with in‐hospital ST‐elevation myocardial infarction
2022
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.
Journal Article
Impact of Gender and Door-to-Balloon Times on Long-Term Mortality in Patients Presenting With ST-Elevation Myocardial Infarction
by
Koshy, Anoop N.
,
Andrianopoulos, Nick
,
Duffy, Stephen J.
in
Aged
,
Angioplasty, Balloon, Coronary - methods
,
Aspirin
2019
Guidelines mandate emergent revascularization in patients presenting with ST-elevation myocardial infarction (STEMI) irrespective of gender. We sought to compare the door-to-balloon times and the impact of timely reperfusion on clinical outcomes in women compared with men presenting with STEMI undergoing primary percutaneous coronary intervention (PPCI). We analyzed data from 6,179 consecutive patients presenting with STEMI undergoing PPCI from the Melbourne Interventional Group registry (2005 to 2017). The primary outcome was long-term mortality. Of the 6,179 patients included 1,258 (20.3%) were female. Female patients were older (69 ± 13 vs 62 ± 12 years; p < 0.001), had more co-morbidities and had longer median symptom-to-balloon times (204 [interquartile range {IQR} 154 to 294] vs 181 [IQR 139 to 258] minutes; p < 0.001) and longer median door-to-balloon times (81 [IQR 55 to 102] vs 75 [IQR 51 to 102)] minutes; p < 0.001), while receiving less drug-eluting stents (39% vs 43%; p = 0.01) and having less radial access for PPCI (15% vs 21%; p < 0.001). Furthermore, female patients received less guideline-directed medical therapy than men with less prescription of aspirin (93.4% vs 95.4%; p = 0.02), statins (96.5% vs 97.6%; p < 0.05), and beta blockers (84.3% vs 89.4%; p < 0.001). Unadjusted in-hospital and 30-day mortality rates were higher in women (8.8% vs 6.2%, 9.8% vs 6.9%; p < 0.001). However, on Cox-proportional hazards modeling, gender was not an independent predictor of long-term mortality (hazards ratio 0.99, 95% confidence interval 0.83 to 1.18; p = 0.92) at a mean follow-up of 4.8 ± 3.5 years. In conclusion, in this large multicenter registry of patients with STEMI, women had longer ischemic times, higher risk profiles, and differing interventional approaches compared with men. Addressing these gender inequalities with early identification of symptoms, adherence to guideline-directed medical therapy, as well as higher rates of radial access and use of drug-eluting stents has the potential to further improve outcomes in women with STEMI.
Journal Article
Assessment of Pretreatment With Oral P2Y12 Inhibitors and Cardiovascular and Bleeding Outcomes in Patients With Non-ST Elevation Acute Coronary Syndromes
by
Stub, Dion
,
Dawson, Luke P.
,
Duffy, Stephen J.
in
Acute Coronary Syndrome - therapy
,
Acute coronary syndromes
,
Aged
2021
The practice of pretreatment with oral P2Y12 inhibitors in non-ST elevation acute coronary syndromes (NSTEACS) remains common; however, its association with improved cardiovascular outcomes is unclear.
To assess the association between oral P2Y12 inhibitor pretreatment and cardiovascular and bleeding outcomes in patients with NSTEACS.
On March 20, 2021, PubMed, MEDLINE, Embase, Scopus, Web of Science, Science Direct, clinicaltrials.gov, and the Cochrane Central Register for Controlled Trials were searched from database inception.
Randomized clinical trials of patients with NSTEACS randomized to either oral P2Y12 inhibitor pretreatment (defined as prior to angiography) or no pretreatment (defined as following angiography, once coronary anatomy was known) among patients undergoing an invasive strategy.
This study followed Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Data on publication year, sample size, clinical characteristics, revascularization strategy, P2Y12 inhibitor type and dosage, time from pretreatment to angiography, and end point data were independently extracted by 2 authors. A random-effects model was used, including stratification by (1) P2Y12 inhibitor type, (2) revascularization strategy, and (3) access site.
The primary end point was 30-day major adverse cardiac events (MACEs). Secondary end points were 30-day myocardial infarction (MI) and cardiovascular death. The primary safety end point was 30-day major bleeding (defined according to individual studies).
A total of 7 trials randomizing 13 226 patients to either pretreatment (6603 patients) or no pretreatment (6623 patients) were included. The mean age of patients was 64 years and 3598 (27.2%) were female individuals. Indication for P2Y12 inhibitors was non-ST elevation myocardial infarction in 7430 patients (61.7%), radial access was used in 4295 (32.6%), and 10 945 (82.8%) underwent percutaneous coronary intervention. Pretreatment was not associated with a reduction in 30-day MACE (odds ratio [OR], 0.95; 95% CI, 0.78-1.15; I2 = 28%), 30-day MI (OR, 0.90; 95% CI, 0.72-1.12; I2 = 19%), or 30-day cardiovascular death (OR, 0.79; 95% CI, 0.49-1.27; I2 = 0%). The risk of 30-day major bleeding was increased among patients who underwent pretreatment (OR, 1.51; 95% CI, 1.16-1.97; I2 = 41%). The number needed to harm to bring about 1 major bleeding event with oral P2Y12 inhibitor pretreatment was 63 patients.
In this study, pretreatment with oral P2Y12 inhibitors among patients with NSTEACS prior to angiography, compared with treatment once coronary anatomy is known, was associated with increased bleeding risk and no difference in cardiovascular outcomes. Routine pretreatment with oral P2Y12 inhibitors in patients with NSTEACS receiving an early invasive strategy is not supported by this study.
Journal Article
Long-Term Outcomes Stratified by Body Mass Index in Patients Undergoing Transcatheter Aortic Valve Implantation
2020
•Outcomes of overweight and obese patients were compared with normal weight patients.•Overweight BMI was independently associated with reduced mortality post-TAVI.•Obese patients were found to be more frail than normal weight patients.
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.
Journal Article