bluuebunny/crossref_metadata_2025 huggingface dataset:
P4697Complications and mortality related to non-cardiac surgery in adult congenital heart disease: Results of a nationwide study including 20,450 cases
Authors: Diller G P , Freisinger E , Bronstein L , Koeppe J , Gerss J , Bauer U , Reinecke H , Baumgartner H
Published: October 2019

Background

Adults with congenital heart disease (ACHD) represent a growing patient population with high morbidity and increasing health resource utilization. In addition to acute and chronic cardiac complications, these patients require numerous non-cardiac surgical procedures during their life-time. Limited data on the morbidity and mortality risk related to non-cardiac surgical procedures exist in contemporary CHD patients. The aim of this study was to analyse the frequency and outcome of non-cardiac surgical procedures in contemporary ACHD patients based on all hospital admissions in Germany between 2011 and 2016.

Methods

Based on the German diagnosis related groups data of patients treated between 2011 and 2016 we identified all ACHD patients treated surgically as inpatients for non-cardiac problems. The dataset contains information on patient demographics, primary and secondary diagnoses, interventional or surgical procedures, duration of stay and outcome including mortality. The primary endpoint of the study was surgery related mortality as well as major adverse events (defined as death or myocardial infarction, stroke, pulmonary embolism, sepsis or resuscitation).

Results

Overall, 48,872 ACHD cases were hospitalized during the study period. Of these, 20,450 (41.8%) were hospitalized for non-cardiac surgical procedures. The median age at surgery was 50.0 years and 62.9% of patients were male. The overall mortality rate following non-cardiac operations was 2.8% (95% CI 2.6–3.0%). The highest mortality rates were observed for procedure codes involving pharynx, larynx or trachea (27.2%; 95% CI: 22.3–32.1%) and lung surgery (15.4%; 95% CI: 13.3–17.8%). Abdominal surgery (9.2%; 95% CI: 7.7–10.9) and neurosurgical procedures (7.8%; 95% CI: 5.4–10.9) also had relative high mortality rates. The major adverse event rate overall was 12.7% (95% CI 11.7–12.7%). The highest major adverse event rates were observed for surgery of the airways (43.2%; 95% CI: 40.2%-46.4%).

Conclusions

Non-cardiac surgical procedures are common in ACHD patients and are associated with considerable mortality and morbidity in this cohort. Especially, surgical procedures involving the airways or neurosurgery emerged as risky procedures. However, even for routine abdominal or orthopaedic surgery considerable mortality and morbidity was observed. Overall, our data support careful pre-operative patient evaluation and concentration of surgical procedures at centres with extensive surgical and anaesthetic experience with ACHD patients.
P4702Blood pressure lowering by peripheral arterial angioplasty
Authors: Busch H L , Stern M , Tzetou K , Sansone R , Heiss C , Kelm M
Published: October 2019

Objective

We hypothesized that the endovascular treatment of flow limiting peripheral stenosis may decrease arterial blood pressure (BP).

Methods

We prospectively enrolled 381 consecutive patients with PAD scheduled for PTA. Clinical baseline characteristics and BP responses to PTA or angiography were analyzed. In a subgroup of 30 patients, we analyzed intra-procedural central aortic BP before and after PTA of iliac (n=15) and femoropoliteal arteries (n=10) and diagnostic angiography (n=5).

Results

Systolic BP (SBP) decreased after PTA of iliac (−19 mmHg, 95% CI: −15, −23 mmHg), femoropopliteal (−12 mmHg, 95% CI: −9, −15 mmHg), and BTK arteries (−7 mmHg, 95% CI: −1, −14 mmHg) but not after diagnostic angiography (−2 mmHg, 95% CI: 2, −6 mmHg) as compared to baseline. Diastolic BP (DBP) decreased after iliac (−5 mmHg, 95% CI: −2, −9 mmHg) and femoropopliteal (−4 mmHg, 95% CI: −1, −6 mmHg) angioplasty, but not after BTK PTA (1 mmHg, 95% CI: 6, −8 mmHg) or angiography (5 mmHg, 95% CI: −10, 12 mmHg). Mean central BP (CBP) acutely decreased after iliac (−20 mmHg [95% CI: −12, −32 mmHg] / −7 mmHg [95% CI: −6, −9 mmHg]) and femoropopliteal artery PTA (−9 mmHg [95% CI: −8, −12 mmHg] / −4 mmHg [95% CI: −3, −6 mmHg]) but not after diagnostic angiography.

Iliac PTA achieved the most pronounced peripheral and central SBP lowering effect (p<0.05, iliac PTA vs. all other).

Baseline clinical and demographic characteristics of overall study population and break-down according to most proximal flow limiting stenosis (a) Baseline characteristics Total Iliac Fempop. BTK Diagnostic n (%) 381 (100) 119 (31) 208 (55) 39 (10) 15 (4) Age (yrs) 70±11 66±11 74±9 70±12 67±12 Male (%) 275 (72) 85 (71) 146 (70) 32 (82) 12 (80) Smoker (%) 241 (63) 98 (83) 114 (55) 20 (50) 9 (60) Hypertension (%) 337 (88) 106 (89) 187 (90) 32 (82) 12 (80) Hyperlipidemia (%) 290 (76) 100 (84) 149 (71) 29 (75) 12 (80) CAD (%) 268 (70) 91 (76) 144 (69) 24 (61) 9 (60) Diabetes (%) 207 (54) 30 (25) 142 (68) 26 (68) 9 (60) Renal failure (%) 167 (44) 38 (32) 101 (48) 22 (57) 6 (40) Antihypertensive treatment (%) 350 (92) 108 (90) 194 (93) 33 (86) 15 (100) Baseline ABI 0.53±0.10 0.56±0.12 0.53±0.1 0.48±0.09 0.54±0.14 ABI before discharge 0.9±0.12 0.94±0.12 0.92±0.11 0.86±0.14 0.54±0.14

pBP baseline vs. post PTA/Angio

Conclusion

Endovascular treatment of proximal PAD lowers significantly central and peripheral blood pressure. Effect size increases with more proximal lesions.
P4708Ttransradial approach for bronchial artery embolization
Authors: Meng Z , Meng J I A , Wang X
Published: October 2019

Background

Bronchial artery embolization (BAE) is considered the most effective nonsurgical emergent treatment for massive hemoptysis, which holds 50%-100% mortality rate if treated conservatively. The transradial approach (TRA) is becoming more popular than the transfemoral approach (TFA) in percutaneous coronary intervention.

Purpose

To compare systematically transradial approach and the transfemoral approach in bronchial artery embolization.

Methods

We had analyzed the clinical, angiographic and technical results of BAE performed between 2014 and 2017. In the present study 58 patients with massive hemoptysis that underwent BAE via the TRA (n=29) or the TFA (n=29) were analyzed. Clinical factors and outcomes in these two groups were compared.

Results

The prevalence of artery vasospasm significantly higher (P<0.05) and the puncture time was significantly longer (P<0.05) in patients who underwent BAE via the TRA rather than via the TFA. However, the complication rate was significantly lower (P<0.05) and the time bedridden (P<0.05) and artery compression time (P<0.05) were significantly shorter via the TRA than via the TFA.

Conclusion

These results suggest that BAE via the TRA was associated with a lower complication rate, and shorter artery compression time and bedridden time than BAE via the TFA. Transradial bronchial artery embolization is technically feasible and safe procedure.
P4711The prognostic impact of infrapopliteal arterial calcification on wound healing in patients with critical limb ischemia
Authors: Hata Y , Iida O , Asai M , Masuda M , Okamoto S , Ishihara T , Nanto K , Kanda T , Tsujimura T , Okuno S , Matsuda Y , Mano T
Published: October 2019

Background

Critical limb ischemia (CLI) is the most progressed manifestation of peripheral artery disease. Although patients with CLI commonly complicate with severely calcified lesions in infrapopliteal lesions, the prognostic impact of infrapopliteal arterial calcification on wound healing in patients with CLI has not been systematically studied.

Purpose

The aim of current study was to elucidate the prognostic impact of infrapopliteal arterial calcification on wound healing in CLI undergoing endovascular therapy (EVT).

Methods

This study enrolled 639 CLI patients with tissue loss (age 74±10 years, male 62%, diabetes 69%, hemodialysis 57%, Rutherford class 5 77%, class 6 23%) primarily treated with EVT for the infrapopliteal lesions between April 2010 and December 2015. Arterial calcification was assessed by high intensity fluoroscopy and classified into 3 groups as follows; 1) none, 2) unilateral and 3) bilateral calcification. The primary outcome measure was complete wound healing. The predictors of the outcome were evaluated by Cox proportional hazards regression analysis.

Results

During a mean follow-up period of 22±19 months, 1-year wound healing rate were 59.0%. In Kaplan-Meier analysis, 1-year wound healing rate was worse in patients with bilateral calcification than in those with unilateral or none calcification (Figure, 46.2% versus 55.1% versus 67.8%, P<0.001). After multivariate analysis, the predictors of wound healing were non-ambulatory status (hazard ratio (HR) 0.67 [95% confidential interval (CI) 0.53–0.85], P=0.001) and bilateral calcification (HR 0.75 [95% CI 0.47–0.98], versus none or unilateral calcification, P=0.036).

Figure 1

Conclusion

Infrapopliteal Arterial calcification as well as non-ambulatory status was associated with wound healing in patients with CLI.
P4722Using the multidimensional prognostic index (MPI) to predict outcome in patients undergoing transcatheter mitral valve repair with MitraClip: a prospective observational single centre study
Authors: Koerber M I , Schaefer M , Vimalathasan R , Baldus S , Pfister R
Published: October 2019

Background

Selection of patients who benefit from percutaneous mitral valve repair (PMVR) is challenging. We used the multidimensional prognostic index (MPI) to evaluate patients' prognosis.

Methods

We conducted a prospective observational single centre study, including patients who did undergo PMVR from 11/2017 to 07/2018. MPI score was used for geriatric assessment and calculated from 63 separate items distributed in eight domains including instrumental activities of daily living, mental status, nutrition, risk of pressure ulcers, comorbidity, medication and marital/cohabitation status.

Results

82 patients were included. Mean MPI-Score was 0.22±0.21. 41 patients (50%) belonged to MPI-1 group (low risk), 37 (45.1%) to MPI-2 group (medium risk) und 4 patients (4.9%) to MPI-3 group (high risk). Due to the low number of patients in MPI-3 group, MPI-2 group and MPI-3 group were combined for statistical analysis. Baseline characteristics, functional assessment and outcome of patients are shown in Table1. During follow-up 4 patients died. All of these belonged to the higher risk group MPI 2/3.

Table1 MPI 1 MPI 2+3 p value Age 73.2±8.8 78.9±7.6 0.002 6 min walk 303±107 175±122 <0.001 EuroScore II (%) 6.61±7.24 7.6±5.55 0.49 EF (%) 43.7±17.2 39.4±15.6 0.36 NT-pro BNP 4611±5413 6045±12670 0.54 Diabetes 7 (17.1) 16 (39) 0.027 Coronary artery disease 25 (61) 26 (63.4) 0.82 Arterial hypertension 26 (63.4) 31 (75.6) 0.23 Barthel index baseline 98±4 80±24 <0.001 Barthel index 30 days 97±5 82±24 <0.001 MLWHFQ baseline 45.7±20.9 49.1±14.5 0.39 MLWHFQ 30 days 38.4±25 34.7±18.2 0.53 ICU stay (days) 1.7±1.2 3.9±7.4 0.069 Death at 30 days 0 4 (10.5) 0.033

Conclusion

The MPI score is associated with age and impaired functional capacity at baseline but not with traditional cardiovascular prognostic markers. Thus, MPI may provide additional prognostic information on mortality and functional outcome of patients beyond established risk scores.
P4725Prognostic relevance of the COAPT inclusion criteria in real-world patients with secondary mitral regurgitation undergoing mitraclip implantation
Authors: Iliadis C , Metze C , Koerber M I , Baldus S , Pfister R
Published: October 2019

Background

The recently published Cardiovascular Outcomes Assessment of the mitraclip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) randomized trial has shown a huge benefit in the survival of patients with systolic heart failure and functional mitral regurgitation treated with MitraClip. However, patients in COAPT were highly selected and the clinical course in real-world patients with and without fulfilment of the trial inclusion criteria is unclear.

Methods

Our study examined the clinical outcome in consecutive patients from our Heart Centre with reduced left-ventricular ejection fraction (EF<50%) undergoing mitraclip for mitral regurgitation of dominant functional etiology by the presence of the inclusion criteria of the COAPT trial (left ventricular ejection fraction >20%, left ventricular end-systolic dimension <70 mm, non-commissural primary jet, estimated pulmonary artery systolic pressure <70 mmHg, mitral valve orifice area >4 cm2, no prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure). The composite endpoint of all-cause mortality or heart failure hospitalization and the endpoint of heart failure hospitalization were analysed.

Results

Among 123 patients who underwent mitraclip implantation 60.2% fulfilled the inclusion criteria of COAPT. Overall, 54 patients (46.6%) died or were hospitalized for heart failure during a median follow-up time of 19 months. The composite endpoint was significantly less frequent (p=0.01) in patients fulfilling the COAPT selection criteria than in those not fulfilling the criteria, with an estimated 1-year event rate of 24.6% vs 49.1%. Patients with COAPT inclusion criteria had a 49% lower hazard of the composite endpoint (95% CI 12–70%, p=0.015). Heart failure hospitalization was significantly less frequent (p=0.039) in patients fulfilling COAPT selection criteria than in those who did not, with an estimated 1-year event rate of 19% vs. 36.8%. Patients with COAPT inclusion criteria had a 50% lower hazard for heart failure hospitalization (95% CI 1–75%, p=0.046). Of note, the 1-year all-cause mortality in our patients fulfilling COAPT inclusion criteria was lower compared to the renowned COAPT trial (10% vs. 19%).

Conclusion

In this single center study the outcome of patients with functional mitral regurgitation undergoing mitraclip therapy was significantly worse in patients not fulfilling COAPT inclusion criteria, indicating that these criteria might help identify futility. The remarkable difference in outcome between real-world patients and COAPT trial patients warrants further study to elucidate underlying causes, which might affect the transferability of the COAPT results.
P4731Procedure-related acute thrombosis after surgical left atrial appendage occlusion for atrial fibrillation
Authors: Inoue T , Shimizu T , Yoshimoto A , Suematsu Y
Published: October 2019

Background/Introduction

Left atrial appendage (LAA) occlusion is an effective strategy for thromboembolism prevention in patients with atrial fibrillation (AF), and the novel methods of occlusion is various. The acute thrombosis after percutaneous LAA occlusion devices has been recently reported, but thrombus formation after surgical LAA occlusion is still unclear.

Purpose

This study aimed to analyse the incidence and prognosis of thrombus formation on closure stump line in patients with AF who underwent surgical LAA occlusion.

Methods

This study retrospectively analised the data from patients treated with two methods of surgical LAA closure, resection or clipping, from January 2014 to November 2018.

Results

A total of 187 consecutive patients with AF underwent surgical LAA closure (31 clipping and 156 stapler resection). 170 patients (91%) underwent cardiac CT for LAA imaging on postoperative day 2. The incidence of acute procedure-related thrombus formation in full cohort was 19% (35 cases). The incidence of acute thrombus in patients with clipping and resection was 19% and 16%, respectively (Fisher's exact test, p=0.8). All of 35 patients who had thrombus on LAA closure stump line underwent cardiac CT again 3 months after the primary CT. In all patients with secondary cardiac CT, thrombus on LAA closure stump line disappeared. No symptomatic thromboembolism occurred during the follow-up from operation to secondary CT scan.

Conclusion(s)

Thrombus formation on stump after surgical LAA closure may often occur on acute phase. The optimal LAA imaging and anti-coagulation therapy after surgical LAA occlusion will prevent patients with acute thrombus from thromboembolism.
P4733Risk of myocardial infarction with coronary artery bypass grafting versus percutaneous coronary intervention: a systematic review and meta-analysis of fifteen randomised trials
Authors: Lee P H , Park H B , Lee J S , Lee S W , Lee C W
Published: October 2019

Background

It remains controversial whether coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) is more effective in the prevention of myocardial infarction (MI). MI has been evaluated only as a secondary endpoint without a focused systematic review in multiple meta-analyses.

Purpose

To compare the risk of MI at the latest follow-up available between CABG versus PCI with stents in patients with multivessel or left main coronary artery disease in a pairwise meta-analysis of randomised controlled trials (RCT).

Methods

We searched EMBASE, Cochrane, and Pubmed databases for articles comparing CABG versus PCI for the treatment of multivessel or left main disease. We utilised random-effects model to calculate pooled risk ratio (RR) and 95% confidence interval (CI). Fifteen trials with a total of 13,592 patients treated with either CABG (n=6,596) or PCI (n=6,996) were eligible and included. A multivariable random-effects meta-regression model, including variables such as age, sex, diabetes mellitus, publication year, follow-up duration, type of stent used, and type of coronary artery disease, was used to explore the source of potential heterogeneity of the primary result.

Results

After a weighted follow-up of 4.3 years, patients treated with CABG had a significantly lower risk of MI than patients treated with PCI (RR 0.75, 95% CI 0.58–0.96, P=0.024, I2=66%). The lower risk of MI with CABG as compared to PCI was more evident during a longer duration of follow-up (≥3 years, RR 0.69, 95% CI 0.52–0.91, P=0.008; ≥5 years, RR 0.64, 95% CI 0.48–0.86, P=0.003) and in diabetic population (RR 0.55, 95% CI 0.44–0.70, P<0.001). There was a statistically meaningful trend toward fewer MIs with CABG with a similar magnitude of risk reduction across patients with left main disease (RR 0.74, 95% CI 0.47–1.15) and multivessel disease (RR 0.72, 95% CI 0.53–0.99). Moderate inter-study heterogeneity could not be explained by the clinical and trial-based variables tested in meta-regression, and is likely because of differences in definitions of MI, risk profile of enrolled patients, and procedural specifics.

Forest plots

Conclusions

In patients undergoing revascularization for multivessel or left main disease, the risk of MI was lower with CABG compared to PCI. The quality assurance for MI definition and treatment-specific procedures should be emphasized for future RCTs.
P4738New combined risk score to predict atrial fibrillation after cardiac surgery
Authors: Burgos L M , Gil Ramirez A , Espinoza J C , Seoane L , Furmento J F , Miranda P R , Villalba L , Cracco M A , Polero L D , Baro Vila R , Berton F , Navia D , Benzadon M N
Published: October 2019

Introduction

Atrial fibrillation after cardiac surgery (AFCS) is associated with an increase in adverse events. The scores POAF, CHA2DS2-VASc and HATCH demonstrated a validated predictive to predict AF after CS (AFCS).

Purpose

To develop and validate a new risk score from the combination of the variables with highest predictive value of POAF, CHA2DS2-VASc and HATCH risk scores to predict AFCS.

Methodology

We conducted a single-center cohort study, performing a retrospective analysis of prospectively collected data. The study included consecutive patients undergoing CS between 2010–2016. The primary outcome was the development of new-onset AFCS during hospitalization. The variables of each score were evaluated in a multivariate regression model to determine the predictive impact. Discrimination was evaluated with area under the ROC curve (AUC-ROC) and calibration using the Hosmer-Lemeshow (HL) test. The Youden index was used to establish the best cut-off point for the score. The statistical difference between the ROC curves was evaluated with the method of DeLong et al.

Results

3113 patients were included. Coronary artery bypass graft surgery 45%, valve replacement 24%, combined procedure (revascularization-valve surgery) 15%, and other procedures 16%. 21% (n=654) presented AFCS. Variables finally included in the new score were: age (≥75: 2, 65–74: 1), heart failure (2), female sex (1), hypertension (1), diabetes (1), previous stroke (1). The new score presented an AUC of 0.78 (95% CI 0.78–0.80), the rest of the scores presented lower discrimination ability (P<0.001): CHAD2DS2-VASc AUC 0.76, POAF 0.71 and HATCH 0.70. The HL test showed a p>0.05. For the new score, the best cut-off point was 2, with a sensitivity of 82% and specificity of 65.9%, presenting high negative predictive value: 92.9%.

Variables OR (CI 95%) P Age (years)   65–74 3.14 (2.29–4.31) <0.001   ≥75 8.68 (6.32–11.93) <0.001 Female sex 3.36 (2.68–4.22) <0.001 Heart failure 2.45 (1.82–3.31) <0.001 Stroke/TIA 2.33 (1.45–3.76) <0.001 Hypertension 1.68 (1.28–2.2) <0.001 Diabetes 1.72 (1.31–2.25) <0.001

Conclusion

From the combination of variables with higher predictive value included in the POAF, CHA2DS2-VASc, and HATCH scores, a new risk system was created to predict AFCS, presenting a greater predictive ability than the original ones. Being necessary future prospective validations.
P4743Inappropriate dosing of non-vitamin K oral anticoagulants (NOACs) in atrial fibrillation patients in Europe
Authors: Palau I , Heinz S , Cheng B Y , Brown S
Published: October 2019

Background

Prescription of Non-vitamin K oral anticoagulants (NOACs) has increased since the first therapies were launched in Europe in 2011, and they are becoming the standard of care in prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). There are concerns about inappropriate NOAC dosing in clinical practice.

Purpose

This paper examines the extent of inappropriate dose prescription among NOAC patients in Germany, Italy, Spain and United Kingdom. Inappropriate dosing refers to patients who do not meet the criteria for dose reduction (under-dose) or patients who should be on the reduced dose as they meet the criteria for dose reduction (overdose).

Methods

Ipsos' Stroke Prevention in Atrial Fibrillation Therapy Monitor was fielded for 6 weeks between January 2017 to February 2017 and 6 weeks between January 2018 to March 2018, with 450 treating doctors in 2017 and 509 in 2018 providing data from 5,692 (2017: n=2,497, 2018: n=3,195) patients with non-valvular atrial fibrillation in Europe. We analysed the results for the 3,477 patients with a NOAC prescription that had sufficient data to decide on the appropriate dose.

Results

Overall, 23.4% of patients (n=813) were receiving an inappropriate dose of dabigatran, rivaroxaban, apixaban or edoxaban. Receiving an under-dose was more common than an overdose (19.2% vs 4.2%).

Ipsos data indicate 32.8% of NOAC patients in EU4 (n=1,139) were prescribed a reduced dose, and Italy had a higher proportion of patients who received a reduced dosed; Italy: 41.0% (n=345), Germany: 30.2% (n=402), Spain: 30.6% (n=216) and UK: 29.4% (n=176). Among these patients, a considerable proportion did not meet the criteria for dose reduction in EU4 (58.6%). This suggests that reduced dose is frequently prescribed to patients when not indicated.

Conclusion

Overall, the majority of patients were prescribed a correct dose according to the product label. However, we see evidence that nearly half of patients receiving a reduced dose were not indicated for a dose reduction. Further research is needed to identify reasons prompting the over-use of reduced dose.
P4745Concomitant oral anticoagulant and antidepressant therapy in patients with atrial fibrillation and risk of stroke and bleeding: a population based cohort study
Authors: Komen J J , Hjemdahl P , Mantel - Teeuwisse A K , Klungel O H , Wettermark B , Forslund T
Published: October 2019

Background

Anticoagulation treatment reduces the risk of stroke but increases the risk of bleeding in atrial fibrillation (AF) patients. Antidepressants use is associated with increased risk for stroke and bleeds.

Objective

To assess the association between antidepressant use in AF patients with oral anticoagulants and bleeding and stroke risk.

Methods

All AF patients newly prescribed with an oral anticoagulant in the Stockholm Healthcare database (n=2.3 million inhabitants) from July 2011 until 2016 were included and followed for one year or shorter if they stopped claiming oral anticoagulant treatment or had an outcome of interest. Outcomes were severe bleeds and strokes, requiring acute hospital care. During follow-up, patients were considered exposed to antidepressant after claiming a prescription for the duration of the prescription. With a time-varying Cox regression, we assessed the association between antidepressant use and strokes and bleeds, adjusting for confounders (i.e., age, sex, comorbidities, comedication, and year of inclusion). In addition, we performed a propensity score matched analysis to test the robustness of our findings.

Results

Of the 30,595 patients included after claiming a prescription for a NOAC (n=13,506) or warfarin (n=17,089), 4 303 claimed a prescription for an antidepressant during follow-up. A total of 712 severe bleeds and 551 strokes were recorded in the cohort. Concomitant oral anticoagulant and antidepressant use was associated with increased rates of severe bleeds (4.7 vs 2.7 per 100 person-years) compared to oral anticoagulant treatment without antidepressant use (aHR 1.42, 95% CI: 1.12–1.80), but not significantly associated with increased stroke rates (3.5 vs 2.1 per 100 person-years, aHR 1.23, 95% CI: 0.93–1.62). No significant differences were observed between different oral anticoagulant classes (i.e., warfarin or NOAC) or different antidepressant classes (i.e., SSRI, TCA, or other antidepressant). Additional propensity-score matched analyses yielded similar results but showed a significantly increased risk for stroke (HR: 1.47, 95% CI: 1.08–2.02).

Incidence rates of strokes and bleeds

Conclusion

Concomitant use of an oral anticoagulant and an antidepressant, irrespective of type, is associated with an increased bleeding risk. Increased awareness and a critical consideration for the need of an antidepressant is recommended in this population.

Acknowledgement/Funding

Swedish Heart Lung Foundation
P4747Impact of different estimates of renal function on cardiovascular mortality and major bleeding in patients with atrial fibrillation on oral anticoagulation
Authors: Hijazi Z , Granger C B , Hohnloser S H , Westerbergh J , Lindback J , Alexander J H , Keltai M , Parkhomenko A , Lopez-Sendon J L , Lopes R D , Siegbahn A , Wallentin L
Published: October 2019

Background

Renal dysfunction is associated with increased risk of cardiovascular events in atrial fibrillation (AF). Estimated glomerular filtration rate (eGFR) can be calculated by different equations based on creatinine or cystatin C. We compared different methods of assessing eGFR and their association with cardiovascular (CV) death and major bleeding in 14,980 AF patients in the ARISTOTLE trial.

Methods

eGFR was calculated using equations based on creatinine (Cockcroft-Gault, MDRD, and CKD-EPI) and/or cystatin C (CKD-EPIcys and CKD-EPIcys+crea). In total five eGFR equations as well as a model based on the variables within the equations were assessed. Associations were evaluated by Spearman correlation, and discriminatory ability for CV-death and major bleeding by Harrell's c-index.

Results

Median age was 70.0 years, and 35.6% were women. Median eGFR (mL/min) were: Cockcroft-Gault 74.1, MDRD 66.5, CKD-EPI 68.5, CKD-EPIcys 74.2, and CKD-EPIcys+crea 72.6. Correlation ranged from 0.49 (Cockroft-Gault and CKD-EPIcys) to 0.99 (MDRD and CKD-EPI). Among the eGFR equations, those based on cystatin C yielded the highest c-indices for CV-death and major bleeding, 0.628 (CKD-EPIcys) and 0.612 (CKD-EPIcys+crea), respectively. A model based on the variables within the eGFR equations (age, sex, weight, creatinine, and cystatin C) yielded the highest discriminatory value for both outcomes, 0.673 and 0.656, respectively.

Figure 1

Conclusions

In patients with AF on anticoagulation, correlation between eGFR methods varied greatly. Cystatin C-based eGFR seem to provide the most robust balance in reflecting the risk of death and bleeding. However, a model based on the individual variables within the eGFR equations provided the highest discriminatory value.

Acknowledgement/Funding

The ARISTOTLE trial was funded by Bristol-Myers Squibb, Co Princeton, NJ and Pfizer Inc., New York, NY.
P4750Uninterrupted and minimally-interrupted direct oral anticoagulant therapy in patients undergoing catheter ablation for atrial fibrillation. An updated meta-analysis
Authors: Ottoffy M , Hegyi P , Habon T
Published: October 2019

Background

Adequate anticoagulation in catheter ablation of atrial fibrillation (AF) is crucial in preventing both thromboembolic events and life-threatening bleeding. As clinicians gain more experience and reassurance with data from clinical trials, the usage of Direct Oral Anticoagulants (DOAC) in patients undergoing catheter ablation of AF has rapidly increased over the last years. The purpose of this updated meta-analysis was to assess the latest evidence and compare the safety and efficacy of uninterrupted and minimally interrupted periprocedural DOAC anticoagulation protocols with uninterrupted Vitamin K Antagonists (VKA) in this setting.

Methods

Randomized or prospective controlled observational studies comparing DOACs to VKAs were identified with multiple databases (Embase, PubMed, Cochrane, and Scopus). Uninterrupted and minimally interrupted DOAC (single dose of dabigatran or apixaban withheld) were distinguished, VKA therapy was always uninterrupted. The primary outcomes were stroke or transient ischemic attack (TIA), major bleeding, and net clinical benefit.

Results

32 studies were included in the final analysis, encompassing a total of 19.437 patients. The incidence of thromboembolic events was rare (less than 0.2%), with no significant difference between groups. Occurrence of major bleeding and net clinical benefit were significantly improved in patients assigned to uninterrupted DOAC treatment compared to VKAs (1.5% vs 2.2%, POR: 0.74, CI: 0.56–0.98, I2=0,0% and 1.7% vs 2.4%, POR: 0.76; CI: 0.59–0.99, I2=0,0%, respectively).

Net clinical benefit

Conclusion

This updated meta-analysis, based on a large database, showed that DOAC therapy is equally effective as VKA in preventing stroke and TIA. Minimally-interrupted DOAC therapy is a non-inferior peri-procedural anticoagulation strategy, however, uninterrupted DOAC therapy showed superiority when compared to VKA regarding major, life-threatening bleeding. Our findings showed that uninterrupted periprocedural DOAC therapy is a safe and preferable alternative to VKAs in patients undergoing catheter ablation for atrial fibrillation.

Acknowledgement/Funding

This study was supported by an Economic Development and Innovation Operative Programme Grant (GINOP 2.3.2-15-2016-00048).
P4754Time to discontinuation of non-vitamin k antagonist oral anticoagulants in patients with non-valvular atrial fibrillation
Authors: Garcia Rodriguez L A , Vora P , Brobert G , Lenz Y , Ruigomez A
Published: October 2019

Background

Despite widespread use of non-vitamin K antagonist oral anticoagulants (NOACs), real-world data on time to discontinuation and time to re-initiation of the NOAC treatment are still scarce.

Purpose

To identify patterns of time to discontinuation as well as time to re-initiation of NOACs in patients with NVAF during the first year of treatment in UK primary care.

Methods

This population-based retrospective cohort study included 11,481 patients with NVAF, aged 18 and above, enrolled in The Health Improvement Network (THIN) with at least 1 year of follow-up after first recorded prescription of apixaban, dabigatran, or rivaroxaban between Jan 2012 to Dec 2016, and received two or more prescriptions of index NOAC. Discontinuation was defined as an interval greater than 30 days between the end of supply of the index NOAC and the date of the next prescription of the index NOAC. Discontinuers were further categorized as switchers, re-initiators or non-re-initiators. Re-initiators were patients who re-started OAC therapy after they discontinued treatment. Proportion of patients who discontinued NOAC treatment as well as mean duration (months) on treatment was calculated.

Results

The majority of patients were continuous users of their initial NOAC; discontinuation within the first year of treatment accounted for 26.1% of the apixaban cohort, 40.0% of the dabigatran cohort, and 29.6% of the rivaroxaban cohort.

Time to discontinuation: Among discontinuers, the mean time patient stayed on initial treatment was the least for dabigatran (4.5 months), followed by apixaban (4.7 months) and highest for rivaroxaban (4.9 months). Discontinuers who did not later reinitiate any OAC therapy had a slightly longer time to discontinuation (mean 5.5 months) than those who later reinitiated OAC therapy (either on the same NOAC, a different NOAC or VKA; mean 4.6 months), or who switched treatment (4.0 months).

Time to re-initiation: Among OAC reinitiators, no difference was seen in the time to re-initiation between NOACs (apixaban – 1.9 months, dabigatran – 2.1 months, and rivaroxaban – 2.0 months.

Conclusion

The proportion of discontinuation among new users of NOAC with NVAF in the first year was 30%. Average time on treatment for switchers, re-initiators and those who completely discontinued shows that such activities occurs around 4–5 months after initiating NOAC treatment, which is when further monitoring might be required. Once discontinued, re-initiation of NOAC treatment on average took 55–65 days.

Acknowledgement/Funding

The study is funded by Bayer AG
P4758Label adherence of non-vitamin K antagonist oral anticoagulants and clinical outcomes in patients with atrial fibrillation: A nationwide study
Authors: Yu H T , Yang P S , Jang E , Kim T H , Uhm J S , Kim J Y , Pak H N , Lee M H , Joung B , Lip G Y H
Published: October 2019

Background

Dose adjustment of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in some patients with atrial fibrillation (AF), based on selected patient factors or concomitant medications.

Purpose

We assessed the frequency of label adherence of NOAC dosing among AF patients and the associations between off-label NOAC dosing and clinical outcomes in real-world clinical practice.

Methods

We evaluated 53,649 AF patients treated with a NOAC using Korean National Health Insurance Service database during the period from January 2013 to December 2016. NOAC doses were classified as either underdosed or overdosed, consistent with U.S. Food and Drug Administration labeling. Cox proportional hazards regression was performed to investigate the effectiveness and safety outcomes including stroke or systemic embolism, major bleeding, and all-cause mortality.

Results

Overall, 16,757 NOAC-treated patients (31.2%) were underdosed, 4,492 were overdosed (8.4%), and 32,400 (60.4%) were dosed appropriately according to drug labeling. Compared with patients with label adherence, those who were underdosed or overdosed were older (71±8 and 75±7 years of age vs. 70±9 years of age, respectively; p<0.001), more likely female (39% and 53% vs. 38%, respectively; p<0.001), and had higher CHA2DS2-VASc scores (4.6±1.7 and 5.3±1.7 vs. 4.5±1.8, respectively; p<0.001). NOAC overdosing was associated with increased risk for stroke or systemic embolism (5.76 vs. 4.03 events/100 patient-years, p<0.001), major bleeding (4.77 vs. 2.94 events/100 patient-years, p<0.001), and all-cause mortality (5.43 vs. 3.05 events/100 patient-years, p<0.001) compared with label-adherent use.

Figure 1

Conclusion

In routine clinical practice, a significant proportion (almost 2 in 5) of AF patients received NOAC doses inconsistent with drug labeling. NOAC overdosing is associated with increased risk for stroke or systemic embolism, major bleeding, and all-cause mortality in Asian patient with AF.
P4760New minimally invasive and tailor-made strategy for cryoballoon ablation in patients with paroxysmal atrial fibrillation
Authors: Nakano T , Suenari K , Suruga K , Takemoto H , Hashimoto Y , Tomomori S , Higaki T , Ooi K , Dai K , Nakama Y , Kawase T , Nishioka K , Otsuka M , Masaoka Y , Shiode N
Published: October 2019

Background

Currently, cryoballoon ablation (CBA) has proven to be highly effective in achieving free from atrial fibrillation (AF), especially paroxysmal AF. However, the optimal freezing protocol for each patient to achieve successful pulmonary vein isolation by only CBA is still uncertain. The aim of this study was to evaluate the clinical implications of a reduction in the freezing duration (<180s) during CBA guided by the time to target temperature.

Methods

From November 2015 to August 2018, 286 consecutive paroxysmal AF patients undergoing CBA were enrolled. We compared 107 patients undergoing a tailor-made CBA procedure (Group A; August 2017-August 2018) to 179 patients with a standard CBA procedure (Group B; November 2015–July 2017). In Group A, the freezing duration was reduced to 150s when the temperature reached ≤−40°C within 40s. Furthermore, we reduced it to 120s when it reached ≤−50°C within 60s. In the other patients, the freezing time was 180s except for excessive freezing over −60°C and/or emergent situations while monitoring the esophageal temperature and for phrenic nerve injury as in Group B.

Results

The baseline clinical characteristics were similar between two groups. In Group A, 89 patients (83%) underwent CBA with a reduction in the freezing time. The rate of having reduction time in left inferior PV (LIPV) and right inferior PV (RIPV) was lower compared with left superior PV (LSPV) and right superior PV (RSPV) (respectively 17%, 29%, 56%, and 63.5%). However, for right inferior PV, in 31 patients having the reduced freezing time, none of them required touch-up ablation. Although the procedure time and frequency of touch-up ablation did not differ between the 2 groups, total freezing time for each PV was significantly shorter in Group A than Group B as shown in figure (LSPV: 164±28s vs. 216±67s; p<0.001, LIPV: 187±44s vs. 218±69s; p<0.001, RSPV: 147±31s vs. 192±51s; p<0.001, RIPV: 180±50 vs. 218±73s; p<0.001). The AF free survival rate during the follow-up period (356±167 days) was similar between the 2 groups (log-rank test, p=0.38). Furthermore, the complication rate was similar 2 groups.

The freezing time for each PV

Conclusion

The safety and efficacy of the new tailor-made CBA strategy were non-inferior to the standard procedure. This study showed that the unnecessary freezing time could be reduced in most of paroxysmal AF patients.
P4769Optimal rivaroxaban dose in Asian patients with atrial fibrillation and normal or mildly impaired renal function
Authors: Choi E.-K , Lee S R , Han K D , Jung J H , Oh S , Lip G Y H
Published: October 2019

Background

Although rivaroxaban 15 mg was only given to patients with creatinine clearance (CrCl) <50mL/min in the pivotal clinical trial, this dose has been commonly prescribed in Asian patients with non-valvular atrial fibrillation (AF) regardless of renal function. There is a paucity of information regarding the clinical outcomes of rivaroxaban 15 mg compared to rivaroxaban 20 mg in patients with CrCl ≥50mL/min. This study aimed to examine the effectiveness and safety of two doses of rivaroxaban in Asian patients with AF and CrCl ≥50mL/min.

Methods

Using the Korean National Health Insurance Service database, patients with AF and normal or mildly impaired renal function (CrCl ≥50mL/min) and naïve to rivaroxaban or warfarin were included from January 2014 to December 2016. Three separate 1:1 propensity score-matched cohorts were conducted: rivaroxaban 20 mg (R20) vs. warfarin (n=15,584), rivaroxaban 15 mg (R15) vs. warfarin (n=11,554), and R20 vs. R15 (n=10,392). Hazard ratios (HRs) for ischemic stroke, intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding, major bleeding, all-cause death, and composite clinical outcome were analyzed.

Results

Among the pooled total study population, mean age was 66.9±10.9 years, 62.2% were male, mean CHA2DS2-VASc score was 3.16±1.79, and mean CrCl was 83.6±42.0 mL/min (median 78.4 mL/min, IQR 67.7–91.0 mL/min). A substantial proportion (42.6%) of patients with CrCl ≥50 mL/min were prescribed off-label R15 for stroke prevention in the Korean AF population. Compared to warfarin, both R20 and R15 showed significantly lower risk for ischemic stroke, major bleeding (mainly through reduction of ICH), and all-cause death (Figure). Overall, both R20 and R15 had better results for the composite clinical outcome compared to warfarin (HR: 0.617, 95% CI: 0.550–0.691 for R20, and HR: 0.759, 95% CI: 0.675–0.853 for R15). Compared to off-label R15, on-label R20 showed a nonsignificant trend toward lower risks of ischemic stroke, hospitalization for GI bleeding, hospitalization for major bleeding, and all-cause death. Overall, on-label R20 had better results for the composite clinical outcome compared to off-label R15 in patients with CrCl ≥50 mL/min (HR: 0.852, 95% CI: 0.735–0.988). This benefit was consistently observed in patients aged ≥80 years and those <50 kg. In patients with CrCl 50–60 mL/min, R20 showed a nonsignificant trend toward a higher risk of hospitalization for major bleeding compared to R15 (HR: 1.828, 95% CI 0.994–3.452).

Conclusions

Among Asians with AF and CrCl ≥50mL/min, both R20 and R15 were associated with reduced risk of ischemic stroke, ICH, major bleeding, and all-cause death without significantly increased risk of GI bleeding compared with warfarin. In patients with CrCl ≥50mL/min, on-label R20 showed better results for the composite clinical outcome compared to off-label R15.
P4772Role of anticoagulation in patients with subclinical AF and its association with cardiovascular events: a SILENT sub study
Authors: Martinelli Filho M , Siqueira S F , Athayde G A T , Dias K M , Pinheiro A O , Oliveira C P , Souza A L , Jorge C H D , Pedrosa A A A , Teixeira R A , Nishioka S A D
Published: October 2019

Background

Atrial fibrillation (AF) is a well-established thromboembolic event risk factor. Episodes of subclinical AF (SCAF) recorded in implantable electronic cardiac devices (IECD) have been related to clinical AF and increased risk of stroke. However, there is no scientific evidence regarding the role of anticoagulation in this population. Objective: Our objective is to assess the association of SCAF with clinical AF and rate of systemic thromboembolic events, in a short-term follow-up.

Methods

This is a sub-study of SILENT, a prospective, randomized, unicentric study which included patients with sinus rhythm, IECD, with CHA2DS2-VASc ≥2, without previous history of AF. Patients were randomized to the Intervention Group and to the Control Group in the 1: 1 ratio. Patients of the Intervention Group with SCAF episodes (>6 min) received anticoagulation, as well as those with clinical AF in both groups. The primary end point was systemic thromboembolic phenomena and the secondary endpoints were SCAF rate, total and cardiovascular mortality, cardiovascular hospitalization and bleeding.

Results

A total of 758 patients were evaluated, with a mean age of 72.81 years (± 9.73), of which 461 (60.8%) were female. The mean follow-up was 19.59±4.24 months. Baseline characteristics were similar in both groups. Only 3 patients presented the primary outcome (two of them from Intervention Group). There were 16 deaths (2,1%) and 44 cardiovascular hospitalizations (5,8%), with no difference between groups. Atrial high rate episodes (AHRE) and clinical AF were more prevalent in Control Group, leading to an equal rate of anticoagulation between groups. Clinical AF was statistically associated to previous atrial high rate episodes of any duration (p=0.001) and correlated with SCAF (p<0.01 and R: 0,60) previously recorded in the device.

Conclusion

This sub study showed that, in a short term follow-up, SCAF has a good correlation with clinical AF occurrence with low rate of thromboembolic events. The Silent study will evaluate in an extended population the role of anticoagulation, in the long term.

Acknowledgement/Funding

None
P4776Age-dependent anti-thrombotic therapy for atrial fibrillation patients with intermediate risk (CHA2DS2-VASc Score of 1 or 2) of ischemic stroke
Authors: Lee K M , Kim M H , Choi S Y , Kim S J , Kim S W , Park J S
Published: October 2019

Background

Although older age is one of the most important risk factor for stroke in atrial fibrillation (AF), it is unclear whether oral anticoagulants are beneficial for AF patients with intermediate CHA2DS2-VASc score (1 for male or 2 for female) according to age threshold. We sought to investigate the effect of age-dependent antithrombotic therapy for ischemic stroke in Korean intermediate risk AF patients.

Methods

We enrolled 29,592 patients (males with CHA2DS2-VASc score of 1 and females with CHA2DS2-VASc score of 2) using the Korean National Health Insurance Service database. The clinical endpoint was the occurrence of ischemic stroke. The propensity score matching method was used to balance covariates across treated and untreated patients.

Results

Treated male AF patients were 6,570 (67.1%) with age <55 years, 7,115 (70.9%) with 55–64 years and 6,470 (68.3%) with 65–74 years in each age risk criterion. Also, treated female AF patients were 3,156 (71.3%) with age <55 years, 2,838 (71.0%) with 55–64 years and 3,440 (72.6%) with 65–74 years in each age risk criterion. Among male and female patients (age <55 years and 55–64 years) with 1 risk factor, an annual ischemic stroke rate was not significantly different between treated and untreated patients at full follow-up. However, treated AF patients who are in age 65–74 year without other risk factor had a much lower annual risk of ischemic stroke [(1.05%/year (male) and 1.04%/year (female)] compared with untreated patients [(1.77%/year (male) (p<0.026) and 1.86%/year (female) (p<0.041).

Conclusions

Age is an important predictor in determining the risk of ischemic stroke in AF patients with intermediate CHA2DS2-VASc scores (1 for male or 2 for female). We suggest that the benefit of anti-thrombotic therapy for intermediate risk AF patients depends on age threshold.