bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of polypharmacy on clinical outcomes in elderly patients with nonvalvular atrial fibrillation: sub-analysis of the ANAFIE Registry
Authors: Yamashita T ,   ANAFIE Registry Group
Published: October 2021

Background

Elderly patients with AF often have multimorbidities leading to treated by polypharmacy, which has been reported to be associated with worse prognosis. Although stroke prevention is a cornerstone of optimal anticoagulation management, data on elderly NVAF patients aged ≥75 years with polypharmacy are lacking.

Purpose

The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry is a prospective, multicenter, observational study that seeks to elucidate real-world data on the clinical status and prognosis of more than 30,000 Japanese patients (aged ≥75 y) with NVAF. This sub-analysis of the ANAFIE Registry assessed 2-year outcomes and the status of anticoagulant management in elderly NVAF patients in view of polypharmacy.

Methods

A total of 32,275 patients from the ANAFIE Registry were divided into 3 groups by the number of concomitant medicines other than oral anticoagulants (OAC) (0 to 4, 5 to 8, ≥9 medicines). The annualized incidence rates of clinical outcomes were determined by Kaplan-Meier analysis. Hazard ratios (HR) for clinical outcomes were determined using the Cox proportional-hazards model.

Results

In the overall population, the mean age was 81.5 y; men accounted for 57.3%; the mean CHA2DS2-VASc score was 4.5; the mean HAS-BLED score was 1.9; the prevalence of paroxysmal AF was 42.1%; the mean follow-up period was 1.88 y; oral anticoagulants (OAC) were used by 92.4% of patients (WF, 25.5%; DOAC, 66.9%); the major concomitant medicines were antihypertensive drugs (70.9%), antiarrhythmic drugs (56.2%), dyslipidemia drugs (37.1%), and proton pump inhibitors (36.6%). The numbers of patients using 0 to 4, 5 to 8, and ≥9 concomitant medicines were 12,186 (37.8%), 13,597 (42.1%), and 5,636 (17.5%), respectively. As the number of concomitant medicines increased, the prevalence of comorbidities and renal dysfunction of creatinine clearance <50 mL/min increased. With an increase in concomitant medications, use of WF increased and that of DOAC decreased. Overall annualized incidence rates (% per patient-year) of clinical outcomes were 1.62 for stroke or systemic embolic events (SEE), 1.08 for major bleeding, 5.91 for cardiovascular (CV) events, 1.08 for CV death, and 3.71 for all-cause mortality. The annualized incidence rates and HR for each clinical outcome are shown in the table. As the number of concomitant medicines increased, the incidence for major bleeding, gastrointestinal bleeding, CV events, and all-cause death were significantly increased.

Conclusions

In elderly NVAF patients from the ANAFIE registry, polypharmacy was associated with increased risks of major bleeding, CV events, CV death, and all-cause mortality.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.
Outcomes of radiofrequency catheter ablation for persistent and long-standing persistent atrial fibrillation
Authors: Azul Freitas A , Sousa P , Goncalves V , Ferreira C , Martinho S , Almeida J , Rosa J , Campos G , Jorge E , Antonio N , Elvas L , Goncalves L
Published: October 2021

Introduction

Catheter ablation has become the first-line treatment for symptomatic patients with atrial fibrillation (AF). Several approaches of substrate ablation have been used for persistent and long-standing persistent AF and the best protocol procedure is yet to be established. The purpose of this study was to evaluate the outcomes of patients submitted to catheter ablation of persistent and long-standing persistent AF adding extra-pulmonary substrate approaches to pulmonary vein isolation.

Methods

We retrospectively studied 67 consecutive patients referred for the first procedure of catheter ablation of persistent or long-standing persistent AF from May 2016 to October 2018. The first 27 patients were subjected to pulmonary vein isolation and complex fractionated atrial electrograms (CFAE) ablation (group 1) and the last 40 patients were subjected to a tailored approach guided by voltage map areas and CFAE (group 2). Patient characteristics, procedure details and follow-up were assessed, and predictors of recurrence were determined.

Results

Mean age was 59±11 years with 58% being male. During a mean follow-up of 16±6 months 27% of the patients showed AF recurrence. There were no differences in baseline characteristics of group 1 and 2. A higher recurrence rate was found in group 1 by comparison with group 2 (40.7% vs 17.5%, Log Rank X2 = 5.076, P=0.024) (Figure 1). Also, recurrence was associated with a longer AF duration, an increased baseline Brain Natriuretic Peptide (BNP), an increased left atrium (LA) volume, the presence of hyperthyroidism, the absence of sinus rhythm after procedure, the inducibility of AF post-ablation and the absence of an antiarrhythmic drug at hospital discharge. After adjustment for other confounders, the patient group (HR 5.16 [1.23–21.71] P=0.025), a long-standing AF (HR 9.09 [1.41–58.82] P=0.020), the BNP value at admission (HR 1.03 [1.01–1.05] P=0.033) and the LA volume index (HR 1.13 [1.02–1.25] P=0.017) were the only independent predictors of recurrence.

Conclusion

Ablation of persistent and long-standing persistent AF is feasible with good results when a substrate approach is added to pulmonary vein isolation. A tailored approach seems to be more efficient, showing best outcomes in mid-term follow-up. A long-standing AF, higher BNP value and the LA enlargement are important predictors of recurrence and should be used to better select patients and to manage follow-up.

Funding Acknowledgement

Type of funding sources: None.
Local impedance characteristics and advanced mapping capabilities to better understand pulmonary veins reconnections during repeat AF ablation procedures: insight from the CHARISMA registry
Authors: Segreti L , Maggio R , Bencardino G , Izzo G , De Lucia R , Notaristefano F , Ricciardi G , Rossi P , Giannotti Santoro M , Ferraro A , Perna F , Solimene F , Stocco C , Malacrida M , Bongiorni M.G
Published: October 2021

Background

Detailed characterization of pulmonary veins (PV) reconnection during repeat AF ablation through high-density mapping (HDM) and local impedance (LI) algorithm is still lacking.

Purpose

We aimed to characterize PV gaps and underlying electrical activity during and after ablation of PVs in AF patients (pts).

Methods

Consecutive patients (pts) undergoing redo AF ablation from the CHARISMA registry with complete characterization of PV gaps (PVG) at 8 Italian centers were included. Rhythmia mapping system was used to map the left atrium and PVs before and after ablation. LI characteristics were collected through a RF ablation catheter equipped with a dedicated LI algorithm (DirectSense). A novel map analysis tool (Lumipoint) that automatically identifies split potentials and continuous activation was used sequentially on each PV component, in order to better assess PVG. Each PVG was characterized in terms of LI and its variations during the procedure. Ablation endpoint was PVI as assessed by entrance and exit block.

Results

Fifty PVGs were automatically identified through the Lumipoint tool in 23 cases, mostly at anterior sites (21, 42%), followed by posterior (15, 30%) and carina (10, 20%) sites. One PVG was identified in 7 (28%) pts, 2 gaps in 10 (43.5%) pts and >2 gaps in 6 (26.1%) pts. The mean LI at PVG sites was 111.3±12Ω prior to ablation: it was significantly higher than LI at scar tissue closer to PVG (99.3±8Ω, p<0.0001) but was significantly lower than LI at healthy tissue (120.8±11Ω, p=0.0015). The mean linear extension of PVGs detected through Lumipoint was significantly lower than the one recognized through voltage map (11.5±8 mm vs 13.3±9 mm, p=0.01) whereas was comparable to the one identified through conventional activation map (11.8±7 mm, p=0.1161 vs Lumipoint). Complete identification of the whole area of PVG was achieved in 31 (62%) and 42 (84%) cases through voltage and activation map, respectively whereas the identification was only partial in 18 (36%) and 7 (14%) cases, respectively. In 1 case both voltage and activation map failed to identify a PVG. No complications during the procedures were reported. All PVs were successfully isolated in all study pts.

Conclusion

Advanced mapping capabilities were useful to pinpoint the search for PVGs, enabling a more targeted ablation approach vs relying on voltage mapping. LI values correlated well with PVGs characteristics and they significantly differ from both scar and healthy tissue.

Funding Acknowledgement

Type of funding sources: None.
Cryoablation: safety of same day discharge
Authors: Carrington M , Silverio Antonio P , Nunes-Ferreira A , Rodrigues T , Cunha N , Couto Pereira S , Brito J , Alves Da Silva P , Valente Silva B , Lima Da Silva G , Carpinteiro L , Cortez-Dias N , J Pinto F , De Sousa J
Published: October 2021

Introduction

Discharge after overnight hospital stay is standard procedure in patients submitted to elective atrial fibrillation (AF) ablation. Taking into consideration the low rate of cryoablation procedure complications could the same day discharge be an option?

Purpose

To assess the safety of same day discharge of patients submitted to AF cryoablation.

Methods

Single-center retrospective study of consecutive patients admitted to elective AF cryoablation in a tertiary center between February 2017 and November 2020. Patients were divided into two groups: same day discharge and next day discharge. Only patients submitted to ablation until 4 p.m. were included. Complication rates were obtained up to six months after the procedure. Complications were defined as death, pericardial tamponade, hematoma requiring evaluation and/or intervention, major bleeding requiring transfusion, hospital admission related to the procedure.

Results

One hundred fifty-four patients were included, with a mean age of 61±10.9 years, 66.2% were males, 18.2% with diabetes, 65.6% with dyslipidemia, 77.9% with hypertension, 10.4% with chronic kidney disease KDIGO stage 3 or more. Median follow-up of 436 [178 – 729] days. Most of the patients had paroxysmal (73.4%) and persistent short duration AF (23.4%). Sixty-two patients (40.3%) were early discharged and there were no differences between the two groups regarding epidemiological and clinical characteristics (p=NS).

A very low rate of complications in both groups was observed, occurring in 6.5% of patients with early discharge and in 8.7% of patients in overnight stay, without statistical significance between the two groups (p=0.61). The most frequent complications were local hematoma (5 patients, 2 in early discharged group), pericardial effusion (3 patients, all in overnight stay), femoral pseudo-aneurism (2 patients, 1 in each group) and arteriovenous fistula (1 patient in overnight stay group). The type of complications did not differ between the two groups (p=0.51). Two patients died during follow up, and this was unrelated to the procedure. In addition, no difference in success rate and arrhythmic recurrence was observed between the two groups (p=NS).

Conclusion

Our study suggests that it is safe to early discharge patients submitted to AF ablation, reducing the hospital stay length in selected patients. Larger studies are needed to confirm this data before routine implementation of this strategy.

Funding Acknowledgement

Type of funding sources: None.
The effect of shared decision-making for stroke prevention on treatment adherence and safety outcomes in patients with atrial fibrillation: a randomized clinical trial
Authors: Noseworthy P , Branda M.E , Kunneman M , Hargraves I.G , Sivly A.L , Brito J.P , Burnett B , Gorr H , Suzuki T , Lee A.T , Jackson E.A , Hess E , Brand-McCarthy S.R , Shah N.D , Montori V.M ,   Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators
Published: October 2021

Background

Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation (AF). We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision making and clinician satisfaction, without affecting encounter length.

Purpose

We aimed to estimate the extent to which use of an SDM tool affected patient adherence to the decided care plan and clinical safety endpoints.

Methods

We conducted a multi-center, encounter-level randomized trial assessing the efficacy of UC with vs. without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice, AC) in patients with non-valvular AF considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months post-enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled [PDC] for DOAC, and as time in therapeutic range (TTR) for warfarin). We also followed for any safety outcomes (stroke [stroke or transient ischemic attack], major bleeding, or death).

Results

We enrolled 922 evaluable patient encounters (AC=463, UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary (78% of patients in AC filled their first prescription vs. 81% in UC) or secondary adherence to anticoagulation (see Figure, PDCDOAC was 74.1% in AC vs. 71.6% in UC; TTRwarfarin was 66.6% in AC vs. 64.4% in UC). PDCDOAC was better (65%) in AC than in UC (55%) (OR 1.49, CIs 1.00, 2.22). Safety outcomes, mostly bleeds, occurred in 13% (AC) of and 14% (UC) of participants.

Conclusions

This is the largest reported randomized trial in AF comparing usual care with and without an SDM tool to promote SDM. Although patients were more actively involved in SDM, we found no significant differences between arms in primary or secondary adherence to anticoagulation or clinical safety outcomes.

Funding Acknowledgement

Type of funding sources: Other. Main funding source(s): The trial was funded by and conducted independently of the National Heart, Lung, and Blood Institute (NHLBI) of the U.S. National Institutes of Health (RO1 HL131535-01). The funding body had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Figure 1
Early rhythm-control therapy in patients with atrial fibrillation: a nationwide cohort study
Authors: Chao T , Chan Y.H , Lip G.Y.H , Chen S.A
Published: October 2021

Background

In the Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST-AFNET 4), early rhythm control was associated with better clinical outcomes for patients with atrial fibrillation (AF). However, the intervention arm had more structured and regular followup, and whether the better outcomes of patients assigned to rhythm control were solely due to “early” intervention or because of more regular and structured follow up was unclear.

Purpose

We aimed to investigate whether the findings of the EAST trial are applicable to the “real world” clinical setting, where a less structured management protocol is operated.

Methods

From 2001 to 2016, 301,064 newly-diagnosed AF patients were identified from Taiwan National Health Insurance Research Database. Among these patients, 62,649 AF patients receiving antiarrhythmic drugs or catheter ablation within 1 year after AF being diagnosed (similar to the timing definition of the EAST-AFNET 4 trial) were categorized as the early rhythm control group, and the remaining 238,415 patients were defined as usual care group. Risk of clinical events were compared between 2 groups.

Results

Compared to usual care, early rhythm control was associated with a lower adjusted risk of ischemic stroke (aHR 0.771, 95CI 0.751–0.792; p<0.001), heart failure (aHR 0.851, 95% CI 0.806–0.891; p<0.001), acute myocardial infarction (aHR 0.915, 95% CI 0.877–0.955; p<0.001), mortality (aHR 0.794, 95% CI 0.782–0.806; p<0.001) and composite adverse events (aHR 0.823, 95% CI 0.813–0.834; p<0.001) (Figure). Compared to usual care, the lower risks of ischemic stroke (aHR 0.746, 95% CI 0.717–0.775), heart failure (aHR 0.819, 95% CI 0.798–0.841), mortality (aHR 0.777, 95% CI 0.759–0.795) and composite adverse events (aHR 0.802, 95% CI 0.787–0.818) associated with early rhythm control were even more evident when performed early (<3 months) than later periods (3–6 months, 7–9 months and 10–12 months; pint <0.001). Principal results were generally consistent for majority of subgroups studied and among the cohort after the propensity matching.

Conclusions

In this nationwide cohort study, early rhythm control therapy was associated with a lower risk of adverse events than usual care among patients with early AF. Outcomes were even better with earlier (<3 months) intervention.

Funding Acknowledgement

Type of funding sources: None.
Anatomical dilation for the coronary sinus ostium in patients with pulmonary arterial hypertension and its impact to trigger the atrioventricular reentrant tachycardia: a case control study
Authors: Ding L , Weng S , Tang M , Zhang S ,   State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Fuwai Hospital, Cardiovascular Institute
Published: October 2021

Background

The incidence of atrioventricular reentrant tachycardia (AVNRT) in pulmonary arterial hypertension (PAH) patients is higher than the general population [1–3]. AVNRT had been reported with larger coronary sinus (CS) ostium in general population, while the mechanism and correlation between AVNRT and the CS ostium in PAH patients are poorly understood.

Purpose

We aim to investigate the impact of the CS ostium on AVNRT and find out its risk factors in PAH patients.

Methods

Of 102 pulmonary arterial hypertension (PAH) patients with catheter ablation of SVT, 10 patients confirmed AVNRT who underwent computed tomographic angiography (CTA) were enrolled as study group. The control group (PAH patients without SVT, n=20) were matched in a ratio of 2:1 based on gender and BMI. We measured maxium diameter of CS ostium in axial and LAO plane by CTA. All baseline characteristics and imaging materials were collected.

Results

PAH patients with AVNRT were older (45.9±14.8 vs. 32.1±7.6 years, P=0.025) and more likely to have larger CS ostium in LAO plane (18.6±3.3 vs. 14.8±4.0 mm, P=0.011) than those without AVNRT. The maximal diameter of CS ostium in LAO plane was an independent predictor for AVNRT in PAH patients (Odds ratio, 1.389; 95% confidence interval, 1.003–1.923; P=0.048). The cut-off value of CS ostium in LAO plane was 14.1mm (Area under curve = 0.79, P=0.012), and the sensitivity and specificity were 90% and 55%, respectively.

Conclusions

The larger CS ostium in LAO plane correlated with the higher prevalence of AVNRT in PAH patients with age. Patients with CS ostium larger than 14.1mm in LAO plane are more likely to develop AVNRT.

Funding Acknowledgement

Type of funding sources: None. Measurements and diagnosis value
Illusion of coronary artery chronic total occlusion-associated ventricular arrhythmia: results from a multi-centre study
Authors: Limaye S.S , Siraj A , Karim S
Published: October 2021

Background/Introduction

Coronary artery chronic total occlusion (CTO) is frequently encountered in patients with established coronary artery disease (CAD) with a reported incidence of more than thirty percent in this population (1). A previous large single-centre study established CTO as an independent risk factor for occurrence of ventricular arrhythmia in patients with ICD and ischemic heart disease (2). The significance of CTO in all-comers has not been investigated. In this large retrospective data, it was analysed that there is no significant difference in ventricular arrhythmia occurrence in patients with CTO versus those with CAD and no CTO.

Purpose

The purpose of this study is to examine the association between CTO and ventricular arrhythmia in patients with CAD using a pooled de-identified database.

Methods

This retrospective observational study used IBM Explorys, which is a pooled de-identified multi-institutional database of more than 60 million unique patients in the United States. A search was done to identify patients with CTO and those with CAD with the exclusion of CTO diagnosis. The data were analysed for ventricular tachycardia (VT) and/or ventricular fibrillation (VF) occurrence. The data were stratified by presence of systolic HF to identify possible effect modification. Statistical analysis was performed by calculating odds ratios (OR) with associated confidence intervals.

Results

Among the 190 patients with the diagnosis of CTO, 11.8% had VT/VF. Of the 2,796,600 patients with CAD and no CTO, 6.9% had VT/VF. The diagnosis of CTO was associated with an increased risk for VT/VF with OR 1.7143 (1.0786, 2.7247), p<0.05. Upon stratification by presence or absence of systolic HF, there was no statistically significant difference in occurrence of VT/VF in the two strata. In the systolic HF group, the OR was 1.4331 (0.6708, 3.0619), p=0.47; the no systolic HF group had OR 0.9717 (0.5123, 1.843), p=0.92. In patients with CAD, the diagnosis of systolic HF was associated with an increased risk of CTO with OR 2.5616 (1.7268, 3.7999), p<0.05.

Conclusion

Stratification by presence or absence of systolic HF yielded inconsistent and statistically insignificant odds ratios compared to the all-comers group, suggesting effect modification by HF with no statistically significant association between CTO and VT/VF. These findings from this large multicentre retrospective data suggest that CTO itself is not an independent risk factor for ventricular arrhythmia in patients with CAD. Limitations of this study include that it is a retrospective pooled analysis without individualised data on ejection fraction and the inability to distinguish if the CTO was infarct-related. Further prospective studies are needed to evaluate the significance of CTO in patients with CAD as it pertains to ventricular arrhythmia.

Funding Acknowledgement

Type of funding sources: None.
Noninvasive functional testing in ANOCA: hyperventilation-exercise study for spasm (SESPASM)
Authors: Dedic S , Boskovic N , Giga V , Nedeljkovic I , Tesic M , Jovanovic I , Aleksandric S , Beleslin B , Picano E , Djordjevic Dikic A
Published: October 2021

Introduction

In patients with angina and no obstructive coronary artery disease (ANOCA), different mechanisms of ischaemia, epicardial spasm, microvascular spasm, and impaired microvascular dilatation frequently coexist.

The aim was to assess CFVR changes during coronary vasoconstrictor and vasodilator stimuli in patients with ANOCA.

Methods

In a prospective single center study, we enrolled 29 ANOCA patients (age 59.6±11 years, 27 females) with previously normal angiograms. All underwent SE testing with hyperventilation (HYP, respiratory rate of 30 per min for 5') followed by supine bicycle exercise (HYP+EXE); and adenosine CFV evaluation (ADO 140 mcg/kg in 1 min) on the other day. Coronary flow velocity (CFV) was assessed in distal LAD by Transthoracic Doppler echocardiography. The ratio of peak/rest changes of CFV during HYP in LAD was taken as an index of vasoconstriction, and CFV reserve was evaluated after EXE. An abnormal response to HYP was a CFV ratio <1.0 (vasoconstrictor response). An abnormal response to ADO was a CFV reserve <2.0 (blunted vasodilatory response). CFVR at peak HYP+ EXE was an indicator of endothelial dependent vasodilatation.

Results

The double product increased during HYP, in comparison to rest (13213 vs 10517, p<0.01), and further increased with EXE (23387 vs HYP, p<0.001). Chest pain or dyspnea were present in 4/29 pts during HYP, and in 7/29 patients during HYP+EXE (13.8% vs 24.1%, p=0.001). ST segment depression (≥1mm) was present in 7/29 patients during HYP, and 14/29 during HYP+EXE (24.13% vs 48.3%, p<0.01). Five patients (17%) showed regional wall motion abnormalities with HYP+EXE. CFVR response was abnormal in 19/29 (65%) patients during HYP+EXE, and abnormal for vasoconstriction during HYP in 13 (44%). Vasodilation during ADO was preserved in all patients.There was significant difference between CFVR response during HYP+EXE and ADO (1.9±0.35 vs 2.47±0.42 respectively, p<0.01), and between CFVR HYP and ADO (1.28±0.29 vs 2.47±0.42, p<0.001).

Conclusion

In patients with ANOCA, HYP+EXE is a more powerful ischemic stress than HYP alone. In over one-half of patients HYP+EXE unmasks abnormalities in CFVR response and/or regional wall motion, likely unmasking the underlying endothelium dependent microcirculatory dysfunction with enhanced vasoconstriction in 44% of the patients and mixed vasoconstriction and reduced relaxation in 65%.

Funding Acknowledgement

Type of funding sources: Public hospital(s). Main funding source(s): University Clinical Centre of Serbia, Faculty of Medicine
Socioeconomic data predict adverse cardiovascular outcomes
Authors: Kostis J.B , Wang J , Dobrzynski J.M , Kostis W.J , Cabrera J ,   MIDAS
Published: October 2021

Background/Introduction

Socioeconomic status (SES) factors predict the occurrence of adverse cardiovascular (CV) outcomes.

Purpose

SES has been studied in many contexts. We present data on SES in a new context using yelp, an American public company that publishes crowd-sourced reviews about businesses. A dataset containing aggregated yelp data for New Jersey zip codes pertaining to the number of fast-food restaurants, grocery stores, gyms and other fitness centers, nursing homes, and pharmacies was created. Cardiovascular outcomes were obtained from the Myocardial Infarction Data Acquisition System (MIDAS).

Methods

Linear regression models of the SES factors were used to predict the occurrence of hospitalized stroke, myocardial infarction (MI), and heart failure (HF).

Results

Overall, the number of fast-food restaurants, grocery stores, nursing homes, and pharmacies were associated with increased rate of adverse CV outcomes, while gyms and other fitness centers were associated with improved outcomes. Also, the SES factors of grocery, nursing home, pharmacy and fast-food restaurants were associated with increased rate of MI (p<0.0001). In addition, the SES factors of grocery, nursing home, pharmacy and fast food were associated with increased rate of HF (p<0.0001). On the contrary, gyms and other fitness centers were associated with lower rate of CV outcomes (p<0.0001). With respect to stroke, the SES factors of grocery, nursing home, pharmacy and fast-food restaurants were associated with increased rate of this condition (p<0.0001, figure). The y axis of the figure is proportional to the square root of the number of strokes in each zip code per 10,000 people.

Conclusions

In conclusion, persons living in zip codes of low socioeconomic status are associated with a high rate of occurrence of MI, HF and stroke. The number of gyms and other fitness centers is associated with a low rate of these outcomes. This information may be important in designing and implementing preventive strategies.

Funding Acknowledgement

Type of funding sources: None.
Ertugliflozin to reduce arrhythmic burden in ICD/CRT patients (ERASe-trial). a phase III study
Authors: Von Lewinski D , Tripolt N , Sourij H , Oulhaj A , Gwechenberger M , Martinek M , Nuernberg M , Roithinger F.X , Steinwender C , Stuehlinger M , Rohrer U , Manninger-Wuenscher M , Scherr D ,   ERASe study group
Published: October 2021

Background and aim

Sodium glucose cotransporter 2 (SGLT2) have proven profound positive effects in heart failure with reduced ejection fraction (HFrEF). These effects are independent from the presence of diabetes. Since SGLT2 receptors are not expressed in human myocardium, these cardioprotective effects be indirect or pleiotropic. Besides metabolic effects anti-inflammatory anti-fibrotic properties are discussed.

Despite a strong correlation of ventricular arrhythmias with HFrEF, the impact of ertugliflozin on the arrhythmic burden has not been investigated, yet. Therefore, the Ertugliflozin to Reduce Arrhythmic burden in ICD/CRT patientS (ERASe) trial was designed to investigate the efficacy and safety of ertugliflozin in diabetic and non-diabetic HFrEF patients.

Methods

Methods: Within a multicentre, national, randomized, double-blind, placebo-controlled, phase 3b trial we aim to enrol a total of 402 patients across Austria. Patients with HFrEF or HFmrEF and ICD±CRT therapy >3 months and previous ventricular tachycardia (at least 10 documented non-sustained VT episodes within the last 12 months) are randomized in a 1:1 ratio to ertugliflozin (5mg once daily orally administered) or matching placebo.

The primary endpoint of the ERASe trial is to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be the number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function quality of life, stress and anxiety.

Conclusion

The ERASe trial will be the first trial to test ertugliflozin in heart failure patients with non-preserved ejection fraction and ongoing ICD/CRT therapy regardless of their diabetic status. The ERASe trial may therefore extend the concept of SGLT2 inhibition to improve cardiac reverse remodelling, including reduced arrhythmic burden.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): unrestricted grant of MSD
Incremental value of atrial sensing in the diagnosis of ICD recordings: findings from the THINGS registry
Authors: Carinci V , Ziacchi M , Iori M , De Maria E , Bolognesi G , Zardini M , Calvi V , Allocca G , Ammendola E , Boggian G , Saporito D , Giorgi D , Grassini D , Giacopelli D , Biffi M
Published: October 2021

Background

Automatic diagnosis of implantable cardioverter defibrillator (ICD) requires confirmation through analysis of electrograms (EGM) recordings by an electrophysiologist (EP) specialist.

Purpose

To investigate whether the atrial sensing capability in single-chamber ICD improves reliability in episodes assessment.

Methods

The THINGS registry enrolled 526 consecutive patients without atrial pacing indication who underwent single-lead ICD implantation. Of them, 343 patients received a conventional single-chamber ICD (ICD VR) and 183 a single-lead ICD with atrial sensing capability (ICD DX, BIOTRONIK). Device-detected ventricular episodes were independently classified by two experienced electrophysiologists as ventricular (VT) or supraventricular tachycardia (SVT) by analyzing the EGMs. In case of disagreement, a third experienced EP specialist, blinded to previous assessment, was consulted. The inter-rate reliability was evaluated using the Cohen's kappa (k) coefficient in the ICD VR and ICD DX group.

Results

A total 441 (383 in the ICD VR and 58 in the ICD DX group) device-detected events were analyzed. Using ventricular EGM alone for ICD VR patients, the proportion of observed agreement between the 1st and 2nd adjudicator was 86.4% consisting of 268 (70.0%) episodes confirmed as VT and 63 (16.4%) classified as SVT. The k coefficient was 0.61 and no agreement was reached for 52 (13.6%) tracings. For them, the third assessment had low agreement with both previous EP evaluations (the k coefficients 1st/3th and 2nd/3th EP specialist were 0.03 and −0.05, respectively).

In ICD DX group, with available atrial EGM, the proportion of observed agreement in the first stage improved to 93.0%: 44 (75.8%) episodes were adjudicated as VT and 10 (17.2%) as SVT with a k=0.79. Only 4 (7.0%) recordings had a discordant classification. For them, the 2nd and 3rd EP specialist had perfect agreement (k=1).

Conclusions

Atrial sensing capability improves EP specialist assessment of ICD episodes allowing dual EGMs analysis. Misinterpretation of ICD recordings may thus be less common in ICD DX than in conventional single-chamber ICD VR and may improve clinical decisions.

Funding Acknowledgement

Type of funding sources: None.
Selectra 3D- guided conduction system pacing: single-center experience
Authors: Marcantoni L , Pastore G , Baracca E , Andreaggi S , Pellegrini N , Galuppi E , Bartolomei M , Centioni M , Rigatelli G , Roncon L , Zanon F
Published: October 2021

Background

Conduction system pacing (CSP)is becoming increasingly popular thanks to the ability to both maintain physiological electrical activation in patients with narrow QRS and restore ventricular synchrony in patients with bundle branch block (BBB). The Selectra3D introducer is a new tool able to support the correct positioning and screwing of the catheter on the bundle of His (HBP) or on the left branch (LBBP). It does exist in 3 different shapes: S, M, L (Fig. 1) based on the radius of main curvature. The internal diameter of 7.3 Fr allows it to support both the 3830 lumen-less catheter historically used for CSP, as well as standard 6Fr stylet-driven leads.

Objective

To evaluate the effectiveness of the Selectra3D introducer for CSP (including both HBP and LBBP), considering the procedural success rate and the lead stability (stability of electrical parameters or need for implant revision) in the medium-term follow-up.

Methods and results

The Selectra3D introducer was used in 56 patients' candidates for CSP (mean age 80±6 years). Pacing indications included A-V block in 21 patients, AF with slow ventricular response in 9 patients; SND in 8 patients and HF and severe ventricular dysfunction in 18 patients (of which 4 were PICM). The mean baseline EF was 40±15%. A PM was implanted in 40 patients and an ICD in 16. A standard stylet-driven lead was used in 48 cases, a fixed exposed screw lead was used in 8 patients. HBP was obtained in 21 cases and LBBP in 30 cases, while in 5 cases (8.9%) neither HBP nor LBBP could be obtained. Implants were performed via a left-sided approach in 55 cases and a right-sided approach in 1 case. The baseline QRS duration was 144±38 ms and the paced QRS duration was 118±21 ms. The electrical parameters were optimal with sensing 8.7±8 mV; impedance 625±276 ohm; threshold 1±0.5 V. During follow-up, 2 lead dislodgement (3.9%) (1 HBP and 1 LBBP) were recorded, both within 7 days after implantation. All the others showed stability of the electrical parameters at a mean follow-up of 8.4±4.2 months.

Conclusions

The new Selectra3D introducer supports effectively and safely the lead implant on conduction system catheters (HBP and LBBP), allowing the implant of both exposed fixed screw leads and standard stylet-driven leads, leading to procedural success>90%. The electrical parameters were optimal at implantation and remained stable during follow-up.

Funding Acknowledgement

Type of funding sources: None. Figure 1
Ten-year follow-up of implantable cardioverter-defibrillator device implantation in non-ischaemic cardiomyopathy – an insight from real world practice in a large district general hospital
Authors: Abramik J , Moore H.L , Doolub G , Dayer M.J , Furniss G
Published: October 2021

Introduction

The benefits of implantable cardioverter-defibrillators (ICDs) in ischaemic cardiomyopathy are well established. The DANISH study, a large randomized controlled trial of prophylactic ICD implantation, found no benefit in preventing all-cause mortality in patients with non-ischaemic cardiomyopathy (NICM). However, ESC guidelines recommend ICDs for patients with NICM and LVEF ≤35% who receive optimal medical therapy (IB recommendation). The 2014 NICE guidelines have similar endorsements but prior to that ICDs were not routinely recommended in NICM in the UK.

Purpose

We evaluated clinical outcomes of patients who had ICDs implanted prior to 2014 in a NICM population at a large district general hospital.

Methods

An ICD database of 454 patients at our district general hospital was retrospectively reviewed. We identified 70 patients who had ICD insertion for non-ischaemic cardiomyopathy between 2006 and 2014. Mean follow up time was 9 years 9 months (SD 23 months). 39 patients had an ICD inserted for primary prevention and 31 for secondary prevention. Data was collected from patients' electronic notes and analysed with relation to baseline demographics, mortality, complications and both appropriate and inappropriate therapy in these two subgroups.

Results

The baseline patient characteristics are presented in Table 1 and show similar characteristics between the primary and secondary prevention groups, except for a higher level of CRT-D implantation in the primary prevention group (p=0.006). Table 2 shows therapy that the device delivered and complication rates.

Overall, 16% of patients with an ICD for non-ischaemic cardiomyopathy received a shock for VF. 41% of patients received appropriate therapy (Shocks or Anti-Tachycardia Pacing (ATP)) from their ICD with median time to first therapy of 30 months (IQR 12–66). Shocks for VF were similar in each group (15% vs. 16%, p=0.919). Six patients (8.6%) had inappropriate shocks and two inappropriate ATP (2.9%). 9 (13%) of patients had a complication either at implant or during follow-up; two had pericardial effusions following implant of which one required pericardiocentesis, three required lead replacement due to lead failure, two developed device infections, one was anticoagulated for a lead thrombus and one patient's device failed to treat VF.

Conclusion

16% of non-ischaemic cardiomyopathy patients received a shock for VF and 41% received ICD therapy for VT or VF over a mean follow-up period of almost 10 years. This was seen in both primary and secondary prevention. Inappropriate shocks and life-threatening complications were uncommon.

Funding Acknowledgement

Type of funding sources: None. Table 1. Patient characteristicsTable 2. ICD therapy and complications
ICD exchange in the elderly
Authors: Ritter O , Pagonas N , Eisert M , Patschan D , Nordbeck P , Buschmann I , Sasko B , Andresen H
Published: October 2021

Background

ICD therapy in elderly patients is controversially discussed, since survival benefits might be attenuated by non-arrhythmic causes of death.

Purpose

This study aimed to investigate the outcome of septua- and octogenarians after ICD generator exchange (GE).

Methods

506 patients undergoing elective GE were analysed to determine the incidence of ICD shocks and survival after GE. For further analysis, patients were divided according to age (70 – 79 or ≥80 years) and previous ICD therapy: patients that did not experience a shock and patients that received at least one shock from prior ICDs.

Results

The effect of the ICD on all-cause mortality and arrhythmic death was determined for two groups (patients with 70 – 79 and ≥80 years). Comparing septua- with octogenarians, similar left ventricular ejection fraction (35.6±11.2% vs. 32.4±8.9%) and baseline prevalence of NYHA class 3 or 4 heart failure (17.1% vs. 14.7%) was found. Older patients were more likely to die of non-arrhythmic death (22% per year vs. 8% per year, p<0.001). We also investigated the necessity of ICD therapy dependent on whether ICD therapy occurred during the previous battery live. Septuagenarians and octogenarians with previous shocks had a higher incidence of further ICD therapy in the following battery life period (41% vs. 19%, p<0.001, and 22% vs. 17%, p<0.001).

Conclusion

Decision making for ICD generator exchange among elderly patients should be considered carefully for an individual patient during clinical practice.

Funding Acknowledgement

Type of funding sources: None.
The tricuspid annulus in cardiac amyloidosis – a three-dimensional speckle-tracking echocardiographic study
Authors: Nemes A , Racz G , Kormanyos A , Foldeak D , Borbenyi Z
Published: October 2021

Introduction

Amyloidosis is a rare condition due to extracellular deposition of excessive amount of protein in parenchymal tissues including the heart. The present study aimed to test whether cardiac amyloidosis (CA) is associated with morphological and functional abnormalities of the tricuspid annulus (TA). For this aim, the results of patients having CA were compared to age- and gender-matched healthy controls by three-dimensional speckle-tracking echocardiography (3DSTE). Moreover, differences in TA parameters between light-chain CA (AL-CA) and transthyretin CA (TTR-CA) were studied as well.

Methods

The study comprised 27 CA patients (mean age: 62.7±9.1 years, 21 males), their results were compared to those of 20 age- and gender-matched healthy volunteers (59.3±3.8 years, 13 males). Current consensus criteria were used for the definition of CA. Biopsy was carried out in all patients to confirm the diagnosis of CA. The first positive biopsy site was the myocardium in 7 cases, bone marrow in 6 cases, duodenum and rectum in 5 cases, salivary gland in 1 case, skin and subcutaneous tissue in 2 cases and kidney in 10 cases in the CA patients. In 5 CA patients, biopsy samples were collected from more than one organ. CA proved to be AL-CA in 21 subjects and TTR-CA in 6 patients. Complete two-dimensional Doppler echocardiography and 3DSTE were performed in all CA patients and controls.

Results

CA patients had significantly higher left atrial diameter, left ventricular (LV) end-diastolic diameter, thicker interventricular septum and LV posterior wall and increased E/A ratio compared to the results of healthy controls. None of the 27 CA patients and their matched controls had atrial fibrillation in their medical history. Dilated 3DSTE-derived end-diastolic and end-systolic TA diameter (3.0±0.6 cm vs. 2.1±0.2 cm, p<0.05 and 2.6±0.6 cm vs. 1.6±0.2 cm, p<0.05, respectively), area (10.7±3.5 cm2 vs. 6.1±1.1 cm2, p<0.05 and 8.0±3.2 cm2 vs. 4.1±1.0 cm2, p<0.05, respectively) and perimeter (12.5±2.0 cm vs. 9.8±1.0 cm, p<0.05 and 10.6±2.1 cm vs. 8.0±1.0 cm, p<0.05, respectively) could be detected in all CA patients and in the AL-CA and TTR-CA subgroups, as well. Although only a few TTR-CA patients were involved, morphologic TA parameters proved to be tendentiously higher as compared to those of AL-CA patients. Functional parameters of TA represented by TA fractional area change (TAFAC, 26.1±11.2% vs. 32.0±11.1%, p=0.07) and TA fractional shortening (TAFS, 12.8±10.3% vs. 21.6±7.4%, p<0.05) were found to be reduced in CA patients, which were more enhanced in TTR-CA patients (TAFAC for TTR-CA: 27.1±14.3% vs. TAFAC for AL-CA:25.7±10.5%, p=ns; TAFS for TTR-CA: 16.0±9.8% vs. TAFS for AL-CA: 11.9±10.4%, p=ns).

Conclusions

Dilated TA is associated with its functional deterioration in CA. Patients with TTR-CA have tendentiously more dilated TA with more enhanced TA functional parameters.

Funding Acknowledgement

Type of funding sources: None.
Characteristics and prognosis in heart failure with preserved ejection fraction patients without left ventricular hypertrophy
Authors: Nakagawa Y , Tamaki S , Yano M , Hayashi T , Yamada T , Yasumura Y , Hikoso S , Sotomi Y , Sakata Y ,   the OCVC-Heart Failure investigator
Published: October 2021

Background

Clinical heterogeneity exists in heart failure with preserved ejection fraction (HFpEF). Left ventricular (LV) structure in HFPEF is characterized by normal LV cavity size and LV hypertrophy (LVH). However some of HFPEF patients do not have LV hypertrophy, and these patients may have distinct characteristics,

Purpose

The purpose of this study is to clarify the clinical characteristics and the prognosis for HFPEF patients without LVH.

Methods

We studied 1097 patients, who were hospitalized for acute decompensated heart failure with LVEF ≥50%, and enrolled in the PURSUIT-HFpEF registry. Laboratory testing and echocardiography were examined in the compensated stage (in stable condition after treatment of acute decompensated HF). We divided these patients into 2 groups based on LV mass index (LVMI) in the compensated stage according to the American Society of Echocardiography/European Association of Cardiovascular Imaging recommendations; patients with LVH (48%) and those without LVH (52%).

Results

Patients without LVH had significantly lower levels of C-reactive protein and N-terminal pro brain natriuretic peptide (NT-proBNP) and higher levels of estimated glomerular filtration rate in the compensated stage than those with it (p<0.05 for all). Cox hazard regression analysis showed that absence of LVH was favorably associated with the primary composite endpoint of all-cause death, HF rehospitalization, and cerebrovascular events (hazard ratio 0.776, 95% confidence interval 0.620-to 0.970, p<0.05).

On the other hand, the frequency of atrial fibrillation (Af) in the decompensated stage was higher in patients without LVH than those with it (52.1% vs 39.3%, p<0.001). Multivariate logistic analysis showed that absence of LVH was independently associated with presence of Af in the decompensated stage (odds ratio=1.520, 95% confidence interval 1.130 to 2.050, P<0.01)

Conclusions

HFPEF patients without LVH have less organ damage and favorable prognosis. Af may play a role in the decompensation of HF in HFPEF patients without LVH.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Roche Diagnostics K.K. (Grant number: not applicable)Fuji Film Toyama Chemical Co., Ltd. (Grant number: not applicable)