Transcatheter aortic valve implantation amid the COVID-19 pandemic: a nationwide analysis of the first COVID-19 wave in the Netherlands.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has put tremendous pressure on healthcare systems. Most transcatheter aortic valve implantation (TAVI) centres have adopted different triage systems and procedural strategies to serve highest-risk patients first and to minimise the burden on hospital logistics and personnel. We therefore assessed the impact of the COVID-19 pandemic on patient selection, type of anaesthesia and outcomes after TAVI. METHODS: We used data from the Netherlands Heart Registration to examine all patients who underwent TAVI between March 2020 and July 2020 (COVID cohort), and between March 2019 and July 2019 (pre-COVID cohort). We compared patient characteristics, procedural characteristics and clinical outcomes. RESULTS: We examined 2131 patients who underwent TAVI (1020 patients in COVID cohort, 1111 patients in pre-COVID cohort). EuroSCORE II was comparable between cohorts (COVID 4.5 ± 4.0 vs pre-COVID 4.6 ± 4.2, p = 0.356). The number of TAVI procedures under general anaesthesia was lower in the COVID cohort (35.2% vs 46.5%, p < 0.001). Incidences of stroke (COVID 2.7% vs pre-COVID 1.7%, p = 0.134), major vascular complications (2.3% vs 3.4%, p = 0.170) and permanent pacemaker implantation (10.0% vs 9.4%, p = 0.634) did not differ between cohorts. Thirty-day and 150-day mortality were comparable (2.8% vs 2.2%, p = 0.359 and 5.2% vs 5.2%, p = 0.993, respectively). CONCLUSIONS: During the COVID-19 pandemic, patient characteristics and outcomes after TAVI were not different than before the pandemic. This highlights the fact that TAVI procedures can be safely performed during the COVID-19 pandemic, without an increased risk of complications or mortality.

Gender differences with short-term vs 12 months dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-years follow-up results of the REDUCE trial.

BACKGROUND: Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study. METHODS: REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months. RESULTS: From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. CONCLUSIONS: The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender.

Update and, internal and temporal-validation of the FRANCE-2 and ACC-TAVI early-mortality prediction models for Transcatheter Aortic Valve Implantation (TAVI) using data from the Netherlands heart registration (NHR).

BACKGROUND: The predictive performance of the models FRANCE-2 and ACC-TAVI for early-mortality after Transcatheter Aortic Valve Implantation (TAVI) can decline over time and can be enhanced by updating them on new populations. We aim to update and internally and temporally validate these models using a recent TAVI-cohort from the Netherlands Heart Registration (NHR). METHODS: We used data of TAVI-patients treated in 2013-2017. For each original-model, the best update-method (model-intercept, model-recalibration, or model-revision) was selected by a closed-testing procedure. We internally validated both updated models with 1000 bootstrap samples. We also updated the models on the 2013-2016 dataset and temporally validated them on the 2017-dataset. Performance measures were the Area-Under ROC-curve (AU-ROC), Brier-score, and calibration graphs. RESULTS: We included 6177 TAVI-patients, with 4.5% observed early-mortality. The selected update-method for FRANCE-2 was model-intercept-update. Internal validation showed an AU-ROC of 0.63 (95%CI 0.62-0.66) and Brier-score of 0.04 (0.04-0.05). Calibration graphs show that it overestimates early-mortality. In temporal-validation, the AU-ROC was 0.61 (0.53-0.67).The selected update-method for ACC-TAVI was model-revision. In internal-validation, the AU-ROC was 0.63 (0.63-0.66) and Brier-score was 0.04 (0.04-0.05). The updated ACC-TAVI calibrates well up to a probability of 20%, and subsequently underestimates early-mortality. In temporal-validation the AU-ROC was 0.65 (0.58-0.72). CONCLUSION: Internal-validation of the updated models FRANCE-2 and ACC-TAVI with data from the NHR demonstrated improved performance, which was better than in external-validation studies and comparable to the original studies. In temporal-validation, ACC-TAVI outperformed FRANCE-2 because it suffered less from changes over time.

Use, timing and outcome of coronary angiography in patients with high-risk non-ST-segment elevation acute coronary syndrome in daily clinical practice: insights from a 'real world' prospective registry.

BACKGROUND: An early invasive strategy (EIS) is recommended in high-risk patients with non-ST-elevation acute coronary syndrome (NSTE-ACS), defined as coronary angiography (CAG), within 24 h of admission. The aim of the present study is to investigate guideline adherence, patient characteristics associated with timing of the intervention and clinical outcome. METHODS: In a prospective registry, the use and timing of CAG and the characteristics and clinical outcome associated with timing were evaluated in high-risk ACS patients. The outcome of early versus delayed invasive strategy (DIS) was compared. RESULTS: Between 2006 and 2014, 2,299 high-risk NSTE-ACS patients were included. The use of CAG increased from 77% in 2006 to 90% in 2014 (p trend <0.001) together with a decrease of median time to CAG from 23.3 to 14.5 h (p trend <0.001) and an increase of patients undergoing EIS from 50 to 60% (p trend = 0.002). Patient factors independently related to DIS were higher GRACE risk score, higher age and the presence of comorbidities. No difference was found in incidence of mortality, reinfarction or bleeding at 30-day follow-up. All-cause mortality at 1­year follow-up was 4.1% vs 7.0% in EIS and DIS respectively (hazard ratio 1.67, 95% confidence interval 1.12-2.49) but was comparable after adjustment for confounding factors. CONCLUSION: The percentage of high-risk NSTE-ACS patients undergoing CAG and EIS has increased in the last decade. In contrast to the guidelines, patients with a higher risk profile are less likely to undergo EIS. However, no difference in outcome after 30 days and 1 year was found after multivariate adjustment for this higher risk.

Effects of radial versus femoral artery access in patients with acute myocardial infarction: A large centre prospective registry.

AIM: This study sought to assess whether radial artery access improves clinical outcomes in patients presenting with acute myocardial infarction compared with femoral artery access. METHODS: This is a single-centre, prospective observational registry of all STEMI and NSTEMI patients who underwent coronary angiography and/or primary PCI in the period January 2010 to December 2013. Primary endpoint was 30-day all-cause mortality. Choice of access was left to the discretion of the cardiologist. Differences in the risk of death at 30 days between patients undergoing transradial intervention versus transfemoral intervention was assessed on an intention-to-treat comparison. RESULTS: Retrospective analysis of prospectively collected data was performed in 3580 patients with an acute coronary syndrome who underwent coronary angiography, of which 1310 had radial artery access. PCI was performed in 77 % of the patients. Before propensity score matching, patients who underwent transradial intervention and those intended to undergo transfemoral approach differed significantly in intra-aortic balloon pump use (1.7 % vs. 6.7 %, p < 0.001), and Killip class (Killip 1: 10.8 % vs. 17.3 %, p < 0.001). 30-day mortality rates were 1.7 % in the transradial group and 4.6 % in the transfemoral group (p < 0.001). After matching on the propensity score, the hazard ratio for 30-day mortality in the transradial group was 0.56 (95 % CI: 0.29-1.07, p = 0.08). CONCLUSION: This registry-based study showed that radial access is associated with improved outcome in patients with an acute coronary syndrome. However, this difference was no longer significant after multivariate and propensity score adjustment for differences in baseline characteristics.

Arteriovenous fistula after intervertebral disk surgery at L4-L5.

We describe a 34-year-old woman who had symptoms of heart failure due to an arteriovenous fistula between the right iliac artery and the inferior vena cava caused by surgery for a herniated intervertebral disk. The literature is reviewed. An intra-arterial placed covered stent was successfully used to close the fistula.