bluuebunny/crossref_metadata_2025 huggingface dataset:
1175Structural progression increases the risk of ventricular arrhythmias in patients with arrhythmogenic cardiomyopathy
Authors: Chivulescu M , Lie Ø.H , Skulstad H , Popescu B A , Jurcut R O , Edvardsen T , Haugaa K
Published: October 2019

Background

Arrhythmogenic cardiomyopathy (AC) is an inheritable cardiomyopathy with incomplete penetrance, variable phenotype severity and poorly described disease progression. It is characterized by high risk of life-threatening ventricular arrhythmias and sudden cardiac death in young individuals. Risk stratification and selection of patients presenting without history of life-threatening arrhythmic events for cardioverter-defibrillator implantation in primary prevention remains challenging.

Purpose

We aimed to assess the impact of disease progression on arrhythmic outcomes in AC patients.

Methods

We included consecutive AC probands and mutation-positive family members with at least one complete follow-up evaluation. Echocardiographic and electrical parameters were defined according to the 2010 Revised Task Force criteria at inclusion and at last follow-up. Structural progression was defined as development of new echocardiographic diagnostic criteria. Electrical progression was defined as the development of new diagnostic depolarization, repolarization and/or premature ventricular complex count criteria during follow-up. Non-sustained ventricular tachycardia or ventricular tachycardia occurring during follow-up defined incident ventricular arrhythmic events.

Results

We included a total of 144 patients (48% female, 47% probands, 40±16 years old). At inclusion, 54 patients (37%) had a history of arrhythmic events, 30 patients (21%) had overt structural disease and 114 (79%) had no or minor structural disease. During 7.0 (IQR: 4.5 to 9.4) years of follow-up, 49 patients (43%) with no or minor structural disease at inclusion developed new structural criteria being defined as progressors. Among 80 participants with no or minor structural disease and no arrhythmic history at inclusion, a first arrhythmic event occurred in 14 (17%). The incidence of arrhythmic events was higher in progressors (11/27, 41%) than in non-progressors (3/53, 6%) (p<0.001) (Figure). Structural progression was associated with higher risk of first arrhythmic events during follow-up when adjusted for sex, age at inclusion and follow-up duration, independent of electrical progression (7.6, 95% CI [1.5, 37.2], P=0.01).

Incident arrhythmic events distribution

Conclusion

Almost half of patients without overt structural cardiac disease at genetic diagnosis develop new structural criteria during 7 years follow-up and 17% experienced their first ventricular arrhythmic event. Structural progression was independently associated with ventricular arrhythmic events during follow-up. These findings highlight the increased risk of arrhythmias when structural abnormalities are detected. Their finding may initiate the evaluation for primary prevention cardioverter-defibrillator implantation.
1197The development and validation of a novel transcatheter microwave renal denervation system
Authors: Qian P , Barry M A , Lu J , Mina A , Ryan J , Bandodkar S , Alvarez S , James V , Ronquillo J , Varikatt W , Kovoor P , Pouliopoulos J , McEwan A , Thiagalingam A , Thomas S
Published: October 2019

Background

Clinical studies of transcatheter radiofrequency renal denervation for treating hypertension have been hampered by the lack of consistent denervation efficacy. Microwave energy is well suited to renal denervation due to its capacity to spare vascular structures due to cooling from adjacent blood flow while enabling deep perivascular heating.

Purpose

We aimed to: 1) develop a transcatheter microwave system capable of safely delivering deep and circumferential perivascular renal nerve ablation, and 2) demonstrate the feasibility, short-term efficacy and safety of transcatheter microwave renal denervation.

Method

A novel 7F transcatheter microwave denervation system was designed, built, and iteratively prototyped in vitro and in 15 sheep. A histological grading system for microwave induced renal arterial and renal nerve injury was devised. The microwave denervation system was validated in an additional 9 sheep, which underwent unilateral renal denervation. Up to 2 microwave ablations were delivered to each artery with maximum power at 100–110W for 480s. Sheep were euthanised at 2–3 weeks post procedure. Gross microscopic histological examination as well as renal tissue norepinephrine content was analysed.

Results

Catheter deployment and ablation was successful in all 19 targeted vessel segments and ablation produced substantial circumferential perivascular injury; median ablation lesion area >395 (IQR 251–437) mm2, depth 17.1 (IQR 15.8–18.4) mm, length 16 (IQR 12–20) mm, without collateral visceral injury. Limiting power to 100W minimised arterial injury, while maintaining a deep circumferential perivascular ablation. At microwave ablation sites, a total of 292 nerve fascicles were identified, median distance from the renal artery of 4.2mm (IQR 2.1–8.8mm), of which 249 (85%) had sustained thermal injury with 128/249 (51%) showing grade 3–4 (moderate to severe) injury. Microwave denervation reduced median functional sympathetic nerve surface area at the renal hilum on anti-tyrosine hydroxylase staining by 100% (IQR 87%-100%), p=0.0039, and median renal cortical norepinephrine content by 83% (IQR 76%–92%), p=0.0078, compared to the paired control kidney.

Conclusion

Transcatheter microwave ablation can produce deep circumferential perivascular ablations over a long segment of the renal artery without significant arterial or collateral visceral injury to provide effective renal denervation. Clinical translation may enable more consistent and complete transcatheter renal denervation and antihypertensive efficacy.

Acknowledgement/Funding

University of Sydney; Western Sydney Local health District; National Health and Medical Research Council of Australia; National Heart Foundation (Au)
1200Changes in nocturnal blood pressure post-renal denervation: comparison of treatment versus control groups in SYMPLICITY HTN-3
Authors: Kario K , Bakris G , Pocock S , Fahy M , Bhatt D L
Published: October 2019

Background

Renal denervation (RDN) impacts blood pressure (BP) differently than anti-hypertensive medications by providing a non-reversible 24-hour change in sympathetic tone that is independent of patient adherence. This might lead to differences in the pattern of BP reduction over the 24-hour period related to diurnal variations in sympathetic tone compared with the timing of drug dosing on BP. This “always on” impact of RDN on BP was observed in the 24-hour Ambulatory BP (ABPM) measurements in the SPYRAL HTN-ON MED and OFF MED trials and raises the question of whether this might also be seen in prior studies of RDN.

Purpose

It is hypothesized that SYMPLICITY HTN-3 did not meet its primary efficacy endpoint, in part, due to improved medication adherence and subsequent BP reductions in the control group. We hypothesized that examination of 24-hour ABPM in HTN-3 would illustrate the effects of improved medication adherence in the control group and reveal differences in the pattern of BP reduction between RDN and control groups, thereby demonstrating an impact on sympathetically mediated BP.

Methods

24-hour ABPM measurements were obtained at baseline and 6 months post-randomization per protocol. ABPM was measured and recorded every 30 minutes and a minimum of 21 daytime and 12 night-time acceptable measurements were required for inclusion in the analysis. Mean and standard error of BP were calculated at each timepoint. Night-time was defined as 1:00–6:00AM.

Results

The figure shows hourly mean ABPM at baseline and 6 months for RDN (A) and sham-control groups (B). Changes in ABPM from baseline to 6 months for RDN and sham control groups are shown in (C). Both the RDN and control groups experienced lower mean hourly BP during the day. In contrast, BP reductions from baseline were greater at night and during the pre-awakening morning hours (1:00–6:00AM) in the RDN group compared with the sham control group. ANCOVA baseline BP-adjusted treatment difference for night-time SBP between RDN and control groups was −3.4 mmHg [95% confidence intervals: −6.7, −0.2; p=0.039]. One possible explanation may be that plasma levels of some antihypertensive medications (such as hydralazine and furosemide) may be lower during night-time hours, lessening the effect of BP reduction in the control group.

Conclusions

Analysis of 24-hour ABPM measurements in the RDN group of HTN-3 demonstrate a consistent separation of curves at 6 months compared with baseline. This separation is also seen in the control group in HTN-3 but is minimal at night-time and in the early morning periods, a time when some medications' impact on BP is lessened. Analyses of ABPM data in additional studies (SYMPLICITY HTN-Japan and SPYRAL First-In-Man trials) are planned to further investigate the role of medication adherence in BP reduction after RDN.

Acknowledgement/Funding

The SYMPLICITY HTN-3 trial is funded by Medtronic.
1273Efficacy and safety of prehabilitation before coronary artery bypass grafting
Authors: Argunova Y , Korotkevich A , Belik E , Pomeshkina S , Barbarash O
Published: October 2019

Purpose

To evaluate the effectiveness and safety of high intensity prehabilitation included in the routine preoperative management of patients with coronary artery disease (CAD) for elective on-pump coronary artery bypass grafting (CABG).

Methods

38 male patients with stable CAD referred to on-pump CABG who either underwent prehabilitation or not were assigned into two study groups. Group 1 patients (n=20, the mean age 61.5 years [55; 64] underwent high intensity treadmill exercises. Group 2 patients (n=18, the mean age 62.0 years [56; 65]) underwent routine preoperative management without prehabilitation. Treadmill exercises in Group 1 patients were performed under hemodynamic control and ECG monitoring. The training power of a workout was calculated based on cardiopulmonary exercise test (CPET) performed before preoperative exercises, and was estimated as 80% of the maximal power obtained during the exercise test. Adenosine loading single-photon emission computed tomography (SPECT) was used to measure the parameters of myocardial perfusion before preoperative exercises and on days 5–7 after CABG in both study groups. Biochemical markers of myocardial damage (troponin I, NT-proBNP) were measured before the training session, after it and then in the postoperative period to assess the safety of the prehabilitation program. In-hospital postoperative complications were recorded and analyzed.

Results

Both study groups were comparable in the main clinical and demographic parameters, intraoperative clinical parameters as well as in preoperative CPET and SPECT results. There were no cases of complications during prehabilitation. The analysis of myocardial perfusion parameters demonstrated that patients who had undergone prehabilitation had significantly higher accumulation of radiopharmaceuticals than those in the control group in basal segments (74.9±3.98% vs. 70.3±7.40% p=0.04), middle (86.7±5.24% vs. 79.6±10.43%, p=0.03) and apical (85.8±5.03% vs. 79.0±8,67%, p=0.02) myocardium. The stress-induced ischemia (SDS) was less pronounced in Group 1 compared to Group 2 (0 scores and 0.9±0.53 scores, respectively, p=0.04). Myocardial perfusion defect significantly decreased during the infusion of adenosine (SSS) (p=0.013), as well as the SDS index (p=0.018) in the prehabilitation group after CABG compared with the baseline. Both groups had similar serum troponin I levels within the normal range before and after CABG. NT-pro BNP levels significantly increased in the postoperative period in patients who did not undergo prehabilitation (p=0.003). Patients who underwent prehabilitation had a significantly lower incidence of the in-hospital postoperative complications compared to patients without exercise trainings (p=0.002).

Conclusion

The inclusion of high intensity preoperative exercises in the routine preoperative management of patients referred to elective CABG is safe and effective method of cardioprotection improving surgical outcomes.
1335Tricuspid anular dilatation is associated with higher mortality in patients undergoing TAVR
Authors: Deseive S D C , Steffen J , Beckmann M , Jochheim D , Curta A , Mehilli J , Hagl C , Massberg S , Hausleiter J
Published: October 2019

Background

Tricuspid annular dilatation is an increasingly recognized entity associated with poor outcomes in patients with valvular heart disease, which led to upvaluation of tricuspid annuloplasty in current European and U.S. guidelines on valvular heart disease.

Purpose

To investigate the prognostic role of tricuspid annular dilatation measured in multi-slice CT (MDCT) datasets in patients undergoing transfemoral aortic valve replacement (TAVR).

Methods

All consecutive patients with available MDCT data undergoing TAVR at our institution between 2013 und 2016 were included. Maximal septal-lateral diameter was obtained from 3-dimensional MDCT datasets. Receiver-operating curves (ROC) analysis was performed to obtain an ideal cut-off for septal-lateral dilatation in systolic and diastolic heart phase. All-cause mortality served as endpoint.

Results

The study included 1137 patients, of whom 299 died within a mean follow-up period of 1.8±1 years. Mean patient's age was 80.6 years and 51.5% were women. TAVR was performed via transfemoral approach in all patients and balloon-expandable prosthesis were used in 69.4% of patients. ROC analysis revealed a cut-off of 45.7 mm for diastolic MDCT scans (n=859) and 36.1 mm for systolic MDCT scans (n=278). Patients above this threshold experienced a significantly higher mortality within the follow-up period (s. attached Figure, hazard ratio 1.63 with 95% CI 1.39 and 1.92, p<0.001). Tricuspid annular dilatation had no impact on procedural outcomes including device failure (2.4 vs. 2.9%, p=0.7), need for permanent pacemaker implantation (17.6 vs. 21.3%, 0.16, acute myocardial infarction (0.3 vs. 1.2%, p=0.18) and acute stroke (1.8 vs. 1.1%, p=0.28) defined according to Valve Academic Research Consortium-2 (VARC-2) criteria.

Conclusion

Tricuspid annular dilatation assessed with MDCT in patients undergoing TAVR is associated with 63% higher all-cause mortality. Future studies will have to determine whether interventional tricuspid annuloplasty techniques can reduce mortality in this group of patients.
1336Outcome analysis of systolic or diastolic CT acquisition prior to transcatheter aortic valve replacement to estimate prothesis size
Authors: Steffen J , Deseive S , Beckmann M , Jochheim D , Rizas K , Curta A , Hagl C , Mehilli J , Massberg S , Hausleiter J
Published: October 2019

Background

Computed tomography (CT) imaging is considered as standard of care for transcatheter aortic valve replacement (TAVR) prothesis sizing. ECG-triggered high-pitch helical CT data acquisition on dual-source CT systems is associated with less contrast volumes, but CT image reconstruction of the aortic valve is limited to a single time point within the cardiac cycle. Although systolic CT imaging of the aortic valve is recommended due to the changes in aortic annulus area during the cardiac cycle, this recommendation is not supported by clinical outcome data.

Purpose

The study aimed to assess the impact of systolic vs. diastolic CT imaging of the aortic annulus for TAVR sizing on patient outcomes in a large series of patients.

Methods

In the study CT images of 1346 patients undergoing TAVR at our centre from 2013–2016 were re-evaluated. Patients were stratified into two groups with 0–35% and 36–99% of the RR-interval as systolic and diastolic CT imaging. Outcomes according to VARC2-criteria at 30 days and long-term survival were analysed.

Results

CTs of 1135 out of 1346 patients were analysed retrospectively, 278 (24.5%) of which were acquired during systole and 859 (75.5%) during diastole. Mean age was 80.6±7.6 years and 52.2% were female. Mean follow-up, available for 83.4% of patients, was 2.1±0.8 years. No significant difference in baseline characteristics was observed across both groups.

Aortic annular area measurements were significantly larger in systole (mean aortic anulus area: systole: 4.8±1.0 cm2; diastole: 4.5±1.0 cm2, p<0.01), resulting in larger implanted valves. Balloon-expandable valves were used in 69.4% of patients; the need for post-dilation did not differ between both groups (systole 4.7%, and diastole 7.5%; p=0.13).

There was no difference between groups concerning the combined endpoints for device success or early safety according to VARC2-criteria. Overall 30-day mortality was 3.4% (systole: 4.2% and diastole: 3.1%, p=0.35). Device failure occurred in 2.7% (systole: 2.9% and diastole: 2.7%, p=0.83). Permanent pacemaker implantation was required in 20.1% (systole: 18.7%, and diastole: 20.5%; p=0.55). Stroke rate at 30 days was 2.9%, n=33 and was similar in the two groups. The landmark analysis demonstrates the 30-day and 1-year mortality rates for both groups (Figure).

Figure 1. Landmark analysis mortality

Conclusion

The current analysis does not suggest that systolic CT imaging for TAVR sizing is associated with improved early or late outcomes. Accordingly, full-cycle CT imaging which usually is associated with higher contrast volumes, should be avoided in this elderly population, which often presents with reduced kidney function.
1347The flu vaccine and mortality in hypertension. A Danish nationwide cohort study
Authors: Modin D , Claggett B , Joergensen M E , Koeber L , Benfield T , Schou M , Jensen J U , Solomon S , Trebbien R , Fralick M , Vardeny O , Pfeffer M A , Torp-Pedersen C , Gislason G , Biering-Soerensen T
Published: October 2019

Background

Influenza infection is associated with an increased risk of acute myocardial infarction (AMI) and stroke. It is currently unknown whether influenza vaccination may reduce mortality in patients with hypertension.

Purpose

To determine whether influenza vaccination is associated with lower risks of death in hypertensive patients without significant cardiovascular or other chronic disease.

Methods

Using nationwide registers, we identified all patients with hypertension in Denmark during 9 consecutive influenza seasons in the period 2007–2016 who were treated with at least 2 different classes of antihypertensive medication (beta-blockers, diuretics, calcium antagonists or renin-angiotensin system inhibitors). Patients who were not 18–100 years old or had ischemic heart disease, heart failure, chronic obstructive lung disease, cancer or cerebrovascular disease were excluded. Prior to each influenza season we assessed the exposure to influenza vaccination. End-points were death from all causes, from AMI or stroke, or cardiovascular death. For each season, patients were followed from December 1 until April 1 the next year, spanning the period of high influenza activity in Denmark.

Results

A total of 608,452 Patients were followed for a median of 5 seasons (interquartile-range: 2–8 seasons), with total follow-up time of 975,902 person-years. The vaccine coverage during study seasons ranged from 26% to 36%. During follow-up, 21,571 patients died of all-causes (3.5%), 12,270 patients died of cardiovascular causes (2.0%) and 3,846 patients died of AMI/stroke (0.6%). Vaccination was associated with older age, Diabetes Mellitus, atrial fibrillation, lower educational level, lower income and higher medication use. In unadjusted analysis considering all seasons, vaccination was significantly associated with increased risk of all-cause death, cardiovascular death and death from AMI/stroke. However, following adjustment for season, age, sex, comorbidities, medications, income, education, and more, vaccination was significantly associated with reduced risks of all-cause death, cardiovascular death and death from AMI/stroke (Figure).

PY, person-years.

Conclusion

In a nationwide study spanning 9 consecutive influenza seasons including more than 600,000 hypertensive patients without significant cardiovascular disease identified through medication use, influenza vaccination was significantly associated with a reduced risk of death from all-causes, cardiovascular causes and AMI/stroke. Influenza vaccination may improve patient outcome in hypertension.

Acknowledgement/Funding

Daniel Modin was supported by the Herlev & Gentofte University Hospital Internal Research Fund and by the Novo Nordisk Foundation.
1405Sequential nephron blockade with diuretics improves diastolic dysfunction in patients with resistant hypertension, a substudy a the PHARES trial
Authors: Fouassier D , Blanchard A , Bobrie G , Boutouyrie P , Azizi M , Hulot J S
Published: October 2019

Introduction

Hypertension is one of the major contributors to cardiac diastolic dysfunction as observed in patients with heart failure and preserved ejection fraction. Different therapeutics strategies have been proposed to control blood pressure (BP) but their independent impact on cardiac function remain undetermined. In patients referred to our center for uncontrolled hypertension, we compared changes in cardiac parameters between two strategies consisting of sequential nephron blockade with intensive diuretics (NBD) or sequential renin angiotensin blockade (RAB).

Purpose

To determine evolution of BNP levels and echocardiographic (TTE) parameters of diastolic dysfunction according to strategies to control BP.

Methods

After 4-weeks treatment with 300mg irbesartan + 12.5mg hydrochlorothiazide + 5mg amlodipine, 140 patients with uncontrolled hypertension were randomized to either complete nephron blockade with sequential introduction of 25mg spironolactone, 20 to 40mg furosemide and 5mg amiloride (NBD group, n=74) or complete RAAS blockade with 5 to 10mg ramipril and 5 to 10mg bisoprolol (RAB group, n=67). BNP levels and TTE parameters according to ESC guidelines were assessed at baseline and week 12.

Results

BNP levels were not significantly different in the two groups at baseline (mean±SD 30.1±37.0pg/mL in NBD versus 22.6±22.3pg/mL in RAB, p=0.147) but significantly decreased in NBD at week 12 (20.1±22.7pg/mL in NBD versus 55.2±60.4pg/mL in RAB, p<0.0001). At week 12, only 9 (12%) patients in NBD presented BNP levels >35pg/mL versus 37 (55%) in RAB (p<0.001).

Concordantly, TTE parameters such as left ventricular end-diastolic diameter (mean±SD, 49±4mm in NBD and 52±5mm in RAB, p=0,004) and left atrial area (16.9±3.6cm2 in NBD and 19.1±3.7cm2 in RAB, p=0,003) improved significantly in NBD group. The proportions of patients presenting ≥2 criteria of diastolic dysfunction according to ESC guidelines in NBD and RAB group respectively were 31.2% and 19.3% at baseline vs. 3.1% and 32.2% after 12 weeks (p=0.001). In a multivariate analysis, NBD treatment was significantly associated with a decline in BNP levels (p<0.01) even after adjustment on daytime systolic BP lowering, heart rate, renal function, age and gender.

Conclusion

In patients with uncontrolled hypertension, intensive nephron blockade with sequential addition of diuretics improves markers of diastolic dysfunction independently of BP lowering.
1418Adverse effects of spironolactone in long-term treatment of resistant arterial hypertension
Authors: Vaclavik J , Jelinek L , Jarkovsky J , Benesova K , Tavacova D , Kamasova M , Kocianova E , Vykoupil K
Published: October 2019

Background

Spironolactone is recommended as a fourth line antihypertensive drug by current hypertension guidelines. This drug had relatively few adverse effects in short term clinical trials, but data about their occurrence during long-term treatment of resistant hypertension are scarce.

Purpose

To evaluate the occurrence and type of adverse effects of spironolactone during long-term treatment and their possible clinical and laboratory predictors.

Methods

We prospectively followed 274 patients with resistant arterial hypertension who started treatment with spironolactone between September 2007 and December 2016. The duration of spironolactone use, its dose, the incidence of adverse events, blood pressure, and laboratory findings were recorded at baseline and during the last clinical examination.

Results

Patients were followed for an average of 35 (± 29) months, the mean dose of spironolactone was 27.5 mg/day. Adverse effects occurred in 72 patients (26.3%) and in 61 (84.7%) lead to discontinuation of spironolactone. The most common adverse reactions were gynaecomastia (30.6%), hyperkalaemia (30.6%) and symptomatic hypotension (26.4%). The mean duration of spironolactone treatment before their occurrence was 25 (± 27) months. According to the Kaplan-Meier curve, the median for the incidence of adverse events would be 97 months (91.5–102.5 months), i.e. 50% of patients could be treated with no adverse events for more than 8 years. Adverse events were more common in the elderly (hazard ratio – HR 1.38, P=0.007), patients with higher baseline serum creatinine (HR 1.12, P=0.035) and patients taking angiotensin receptor blockers (HR 1.65, P=0.040).

Kaplan-Meier estimate – adverse events

Conclusion

During long-term treatment of resistant hypertension with spironolactone, more than a quarter of patients experience adverse reactions that usually require discontinuation of spironolactone.

Acknowledgement/Funding

Supported by the grants of Palacký University in Olomouc Nr. IGA_LF_2016_038 and IGA_LF_2017_029.
1443Safety of red yeast rice supplementation: a systematic review and meta-analysis of randomized controlled trials
Authors: Fogacci F , Banach M , Mikhailidis D P , Bruckert E , Toth P P , Watts G F , Reiner Z , Mancini G B J , Rizzo M , Mitchenko O , Pella D P , Fras Z , Sahebkar A F G , Vrablik M , Cicero A F G
Published: October 2019

Background

Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity.

Purpose

Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve the lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs).

Methods

Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in association with other nutraceutical compounds), monacolin K administered daily dose (≤3, <3–5 and >5 mg/day), follow-up (>12 or ≤12 weeks), with statin therapy or statin-intolerance and type of control treatment (placebo or statin treatment).

Results

Data were pooled from 52 RCTs comprising 110 treatment arms, which included 8503 subjects, with 4421 in the RYR arm and 4287 in the control one. Monacolin K administration was not associated with increased risk of MuD (odds ratio [OR]=0.94, 95% confidence interval [CI] 0.53,1.65). (Figure below presents the forest plot comparing the RYR associated risk of MuD in the entire population). Moreover, we found a reduced risk of Non-MuD (OR=0.59, 95% CI 0.50, 0.69) and SAE (OR=0.54, 95% CI 0.46, 0.64) vs. control. Subgroups analyses confirmed the high tolerability profile of RYR. Furthermore, increasing daily doses of monacolin K were negatively associated with increasing risk of Non-MuD (slope: −0.10; 95% CI: −0.17, −0.03; two-tailed p<0.01).

Forest plot on RYR link with MuD risk.

Conclusions

Based on our data, RYR use as lipid-lowering dietary supplement seems to be overall tolerable and safe in a large population of moderately hypercholesterolaemic subjects.

Acknowledgement/Funding

None
2140Association of arterial stiffness with left atrial structure and phasic function: a community-based cohort study
Authors: Yoshida Y , Nakanishi K , Daimon M , Ishiwata J , Sawada N , Hirokawa M , Kaneko H , Nakao T , Mizuno Y , Morita H , Di Tullio M R , Yatomi Y , Homma S , Komuro I
Published: October 2019

Background

Increased arterial stiffness is recognized as an independent risk factor for atrial fibrillation, although the pathophysiological mechanisms remain unclear. Cardio-ankle vascular index (CAVI) is emerging as an important tool to assess arterial stiffness noninvasively which is derived from the concept of stiffness β index and is less dependent on blood pressure at the time of measurement than pulse wave velocity.

Purpose

This study aimed to investigate the association of arterial stiffness with left atrial (LA) volume and phasic function in a community-based cohort.

Methods

We included 1,156 participants without overt cardiovascular disease who underwent extensive cardiovascular examination. Arterial stiffness was evaluated by CAVI. Speckle-tracking echocardiography was employed to evaluate LA phasic function including reservoir, conduit and pump strain as well as left ventricular global longitudinal strain (LVGLS).

Results

CAVI was negatively correlated with reservoir and conduit strain (r=−0.37 and −0.45, both p<0.001; Figure), whereas weakly, but positively correlated with LA volume index and pump strain (r=0.12 and 0.09, both p<0.01). In multivariable analysis, CAVI was significantly associated with reservoir and conduit strain independent of traditional cardiovascular risk factors, pertinent laboratory parameters and LV morphology and function including LVGLS (standardized β=−0.22 and −0.26, respectively, both p<0.001), whereas there was no independent association with LA volume index and pump strain. In the categorical analysis, the abnormal CAVI (≥9.0) carried the significant risk of impaired reservoir (<31.4%) and conduit (<12.4%) strain (adjusted odds ratio = 2.63 and 3.71 vs. normal CAVI, both p<0.01) in a fully-adjusted model including laboratory and echocardiographic parameters.

Figure 1

Conclusion

Arterial stiffness was independently associated with LA reservoir and conduit function, even in the absence of overt cardiovascular disease. This association may explain the higher incidence of atrial fibrillation in individuals with increased arterial stiffness.
2167Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results from the SPAIN study
Authors: Baron Esquivias G , Morillo C M , Moya A M , Martinez Alday J D , Ruiz-Granell R , Lacunza J D , Garcia-Civera R , Gutierrez-Carretero E , Romero-Garrido R
Published: October 2019

Background

Reflex vasovagal syncope (VVS) is one of the most common causes of syncope and, when recurrent, can have devastating consequences on the quality of life of patients despite pharmacological interventions. The closed loop stimulation (CLS) pacing algorithm converts, during an incipient VVS, variations in right intracardiac impedance into heart rate adaptation. The study SPAIN was the first randomized, double-blind trial robustly showing a strong reduction in syncopal recurrence in patients paced with dual-chamber (DDD)-CLS. (NCT01621464).

Purpose

To evaluate whether the differences observed in the SPAIN study regarding syncope burden and time to recurrence translate into improvements on quality of life.

Methods

This study analysed quality of life data from the SPAIN study: a randomized, prospective, double-blind, multicenter trial conducted in 10 Spanish and 1 Canadian centers. Ethics Committee approval was obtained at each participating center. Patients aged ≥40 years, with ≥5 VVS episodes and cardioinhibitory response to head-up tilt testing were included. After implant, patients were randomized 1:1 to active DDD-CLS mode for 12 months followed by sham DDI mode for the remaining 12 months or vice-versa. Quality of life was assessed via the Short Form-36 (SF-36) health survey before randomization (baseline), and at 12- and 24-month follow-up. The change in quality of life during the entire follow-up relative to baseline was compared between each pacing mode (DDD-CLS vs. DDI).

Results

Fifty-four patients were enrolled with a mean age of 56.3±10.6 years and a median of 12 syncopal episodes before randomization. Median SF-36 scores greatly increased from baseline in the DDD-CLS group across the 8 domains, whereas the response was variable in the DDI group. Comparing both pacing algorithms, median SF-36 scores were higher in the DDD-CLS group, with differences reaching statistical significance for “physical role” and “vitality” domains (p-value =0.006 and 0.014, respectively). Pacing sequence or treatment period did not significantly influence the response (p-value >0.05 for all the domains).

Conclusions

We demonstrated the beneficial effect of this physiological pacing algorithm on the quality of life of patients, as evidenced by the improvement in all the domains of the SF-36 when stimulated in DDD-CLS as compared to the sham DDI mode.
2225“New-onset atrial fibrillation efter cardiac surgery is associated with increased long-term morbidity and mortality”: a population-based study from the SWEDEHEART-registry
Authors: Taha A , Jeppsson A , Friberg L , Nielsen S , Ahlsson A , Bjorck S , Bergfeldt L
Published: October 2019

Background

New-onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, but the prognostic implications are not settled. In contrast to previous reports, a recent Danish study in coronary bypass surgery (CABG) patients (Butt et al. JAMA Cardiol 2018) did not show any increased risk for thromboembolic complications in POAF patients.

Purpose

To compare long-term outcome in patients with vs. without POAF after CABG.

Methods

All CABG patients in Sweden 2005–2015 (n=38040) were included in a retrospective population-based cohort study. Data from the SWEDEHEART registry, the National Patient Registry and the National Population Registry were merged. POAF was defined as any new-onset atrial fibrillation (AF) episode up to the 30thpostoperative day. Inverse Probability Treatment Weighting (IPTW) adjusted Cox regression models were used to compare outcome variables after the first 30 postoperative days until the end of follow-up (median 5 years, range 0–10). The models were adjusted for age, gender, CHA2DS2-VASc score, co-morbidity, and medications.

Results

The mean age of the entire cohort was 68 years, 79% were men and 90% had a CHA2DS2-VASc score ≥2. The incidence of POAF was 28.5% (10845/38040). During follow-up POAF, patients had a significantly higher adjusted risk for all-cause mortality [Hazard Ratio (HR) 1.16 (95% CI 1.09–1.24)], ischemic stroke [HR 1.19 (1.09–1.30)], transient ischemic attack [HR 1.17 (1.03–1.33)], pulmonary embolism [HR 1.24 (1.01–1.54)], myocardial infarction [HR 1.14 (1.04–1.25)], heart failure hospitalizations [HR.1.46 (1.35–1.59)] and recurrent AF [HR 4.33 (4.09–4.65)].

Conclusions

POAF was in this comparatively large study associated with increased risk for mortality and morbidity during long-term follow-up after CABG and is hence not a trivial complication.
2286Clinical correlates and outcomes of methamphetamine-associated cardiovascular disease among hospitalised patients in California
Authors: Curran L A , Nah G , Crawford M , Parikh N I
Published: October 2019

Background

Methamphetamine abuse is a growing public health crisis, affecting an estimated 33 millions users worldwide. It is associated with the development of several cardiac pathologies, however the incidence and predictors of cardiovascular disease among methamphetamine users remains unclear.

Purpose

We aim to describe the clinical characteristics of methamphetamine users identified from a large cohort of hospitalised patients. Through comparison of methamphetamine users who develop cardiovascular disease (CVD) with those who do not, we aim to identify predictors of these cardiac conditions.

Methods

We studied the clinical and sociodemographic characteristics (via ICD-9 codes) of methamphetamine users using a database of hospitalised patients in California, captured by the Healthcare Cost and Utilization Project (HCUP) between 2005–2011. We used Cox proportional hazards model for incidence of methamphetamine-associated cardiac pathologies (pulmonary hypertension, congestive heart failure, stroke and myocardial infarction) among methamphetamine users.

Results

Amongst 20,249,026 persons in HCUP, we identified n=66,199 patients as methamphetamine users. Methamphetamine users were younger (33±11.6 years) and more frequently male (63.3%) when compared to non-users (45±19.5 years, 44.4% male). They were also more likely to smoke (26% vs 4%) and concurrently abuse alcohol (7% vs 1%).

Methamphetamine use was associated with a 32% increased risk of CVD (HR 1.32, CI 1.26–1.38); higher than those who abuse alcohol (HR 1.28, CI 1.27–1.38), but lower than in those who abuse cocaine (HR 1.47, CI 1.40–1.54), when compared to non-users. Of the 4 CVD types studied, methamphetamine use was most strongly associated with the development of congestive heart failure (HR 1.53) and pulmonary hypertension (HR 1.42). Whilst male gender (HR 1.73) was a significant predictor of myocardial infarction among methamphetamine users, female gender was not found to be a significant risk factor for the development of any of the studied pathologies. Chronic Kidney Disease (HR 2.38, CI 1.74–3.25) and hypertension (HR 2.26, CI 2.03–2.51) were the risk factors most strongly associated with development of CVD among methamphetamine users.

A Kaplan-Meier plot was constructed (figure 1), comparing the time-to-event for development of CVD among users of either methamphetamine, alcohol or cocaine, with non-users. Methamphetamine and cocaine users both had a higher incidence of CVD after 5 years, when compared to those who abuse alcohol only.

Conclusions

Methamphetamine users are at increased risk of CVD when compared to the general hospitalised population. They have a similar risk of CVD as users of cocaine and a higher risk than those who abuse alcohol. Whilst male gender appears to be a risk factor for myocardial infarction among methamphetamine users, there was no significant association found between female gender and the development of CVD in this population.
2373Effect of ethninicty on in-hospital outcomes of takotsubo cardiomyopathy, data from the national inpatient sample database
Authors: Zaghlol R , Desale S , Barac A
Published: October 2019

Background

The effect of ethnicity on in-hospital outcomes of takotsubo cardiomyopathy (TC) is unknown.

Purpose

To investigate ethnic variations in hospital outcomes of TC in a large nationwide sample.

Methods

The National Inpatient Sample (NIS) database was searched from 2004 to 2014 for the ICD-9-CM code 429.83 to obtain weighted estimates of TC hospitalizations. Based on self-reported ethnicity, African-Americans (AA) and Hispanics were compared to Caucasians for differences in baseline characteristics and in-hospital outcomes. Multivariate regression models were used to adjust for potential confounders.

Results

Of 103891 hospital admissions identified, 89624 (86.3%) were Caucasians, 8026 (7.7%) were AA and 6241 (6%) were Hispanics. Caucasians were older with more females as compared to AA and Hispanics (67.5 [0.13] vs 61.8 [0.45] vs 63.2 [0.52] years, p<0.0001) and (78135 [87.2%] vs 6672 [83.1%] vs 5196 [83.3%], p<0.0001) respectively. Patients' demographics and baseline characteristics are shown in table 1. In unadjusted analysis (Figure 1), compared to Caucasians, AA had more cardiac arrests (304 [3.79%] vs 2569 [2.87%], p=0.038), invasive mechanical ventilation (1671 [20.8%] vs 15897 [17.7%], p<0.002) and tracheostomies (242 [3%] vs 1600 [1.8%], p=0.0009). When comparing Hispanics to Caucasians, Hispanics had higher mortality (426 [6.83%] vs 4573 [5.1] deaths, p=0.007). In adjusted analysis for baseline characteristics differences and hospital location/teaching status, AA had less cardiogenic shocks (OR=0.71 [95% CI 0.56–0.91], p=0.006) and intraaortic balloon pump support (OR= 0.6 [95% CI 0.39- 0.93], p=0.023) but required longer hospitalization (1.64 vs 1.56 log transformed-days, p=0.0001) as compared to Caucasians. Hispanics still had higher mortality than Caucasians (OR =1.27 [95% CI 1.01–1.61], p=0.04).

Table 1. Patients' demographics and baseline characteristics Parameter Caucasians African Americans Hispanics Total p-value Age, years 67.46 (0.13) 61.77 (0.45) 63.15 (0.52) 66.76 (0.12) <0.0001 Females 78,135 (87.18%) 6,672 (83.13%) 5,196 (83.25%) 90,003 (86.63%) <0.0001 Congestive heart failure 20,693 (23.09%) 2,066 (25.73%) 1,395 (22.36%) 24,155 (23.25%) 0.055 Chronic lung disease 26,815 (29.92%) 1,971 (24.54%) 1,200 (19.22%) 29,986 (28.86%) <0.0001 Diabetes mellitus 15,295 (17.07%) 2,071 (25.79%) 1,711 (27.41%) 19,077 (18.36%) <0.0001 Chronic kidney disease 9,065 (10.11%) 1,315 (16.37%) 795 (12.74%) 11,174 (10.76%) <0.0001 Smoking 29,535 (32.95%) 2,660 (33.13%) 1,303 (20.87%) 33,498 (32.24%) <0.0001

Figure 1. In-Hospital Outcomes

Conclusion

There is ethnic variation in hospital outcomes of takotsubo cardiomyopathy, some of which may be related to differences in patients' demographics and baseline characteristics.

Acknowledgement/Funding

Medstar Georgetown University Hospital/ Washington Hospital Center graduate medical education department funded the purchase of the database
2404The use of wearable cardioverter defibrillator in France
Authors: Marijon E , Garcia R , Gras D , Sadoul N , Guedon-Moreau L , Leclercq C , Extramiana F , Lellouche N , Defaye P , Combes N
Published: October 2019

Background

The wearable cardioverter defibrillator (WCD) has been shown to be useful during transient periods of high sudden cardiac death risk, and the issue of compliance recently pointed out. This Registry was designed to provide real-world data on WCD use in France, in terms of compliance, potential adverse events, as well as efficacy.

Methods and results

Multicenter evaluation (WEARIT FRANCE Registry) was conducted in France between January 2017 and March 2018. Overall, 1,157 patients were analyzed: 950 with ischemic heart disease (82%, including 647 patients after myocardial infarction), 119 after ICD explant (10%), and 88 pre-transplant (8%). The median age was 61 years; the median ejection fraction was 25%. Median WCD wear time was 62 days, with median daily use of 23.4 hours. Less than 1% of patients did not wear WCD at least 4 hours per day. During follow-up, a total of 42 sustained ventricular tachyarrhythmias (VT/VF) occurred in 36 patients, of whom 50% (n=18) received appropriate WCD shocks, giving an incidence of appropriate therapy of 1.56%. The rate of all VT/VF episodes were 3.1% among patients with ischemic cardiomyopathy (n=29/950) versus 3.4% for the others (n=7/207). Of the ischemic patients wearing beyond 30 days (N=784), 5 received appropriate therapy of VT/VF episodes. Overall shock survival was 100%. At the end of the WCD period, 586 patients (51%) were implanted with an implantable cardioverter defibrillator. Eight patients (0.69%) received inappropriate WCD shocks. Regarding the apparent very low proportion of women considered for WCD therapy, we aimed to appreciate in which extent

Conclusions

In this multicenter nationwide WCD evaluation, 3.1% of patients presented with sustained VT/VF with 47% of those patients developing VT/VF after 30 days. The incidence of inappropriate therapy was low. The compliance to WCD in this real life evaluation was very high. These data suggest that the WCD, when worn appropriately, may be helpful in the arsenal to protect high-risk patients against SCD, especially in case of transient risk situations.

Acknowledgement/Funding

Zoll
2405When do cardiac rhythm management device complications occur?
Authors: Brough C E P , Wright D J
Published: October 2019

Background

The rate of implantation of cardiac rhythm management devices continues to increase but it is difficult to compare the complication rates of routine cardiac implantable electronic device procedures as the follow-up durations published in literature vary widely (peri-procedure to 3 years).

Purpose

We demonstrate the appropriate follow-up duration for a complication to be attributed to an index procedure, by analysing the complications within the first year of routine cardiac implantable electronic device procedures (primary implant, generator replacement, lead revision only, generator and lead revision, system upgrade and reburial) and the timing of complication interventions.

Methods

A retrospective database was constructed of all de novo CIED operations performed at a tertiary cardio-thoracic centre between April 2008 – March 2016. Procedures were identified from theatre logbooks, with demographic and procedural data extracted from contemporaneously maintained health records (paper and electronic). Objective complications were defined as follows; 1. Any pneumothorax identified on chest x-ray, 2. Any pericardial effusion identified on transthoracic echocardiogram performed post procedure due to intra-operative clinical concern, 3. Haematoma requiring surgical evacuation, 4. Device pocket revision or system reburial, 5. Lead intervention requiring repositioning or placement of a new lead and 6. System explant/ extraction due to any indication. Post-operative complications were identified through theatre log books and cross-referenced with 3 contemporaneously maintained records (clinical health records, TOMCAT electronic database, audit department archive). All data collection was performed by a single investigator, independent of the procedures performed and operating physicians.

Results

10,125 procedures were reviewed; 6,583 primary implant procedures, 2,170 generator replacements, 382 lead revisions, 253 generator and lead interventions, 575 system upgrades and 162 reburial procedures. The procedures involved 3,403 female patients and 6,722 male, with a median age 73 years (±13.7). 2,303 procedures were acute and 7,822 elective. The complication rates were; 4.3% primary implant, 4.0% generator replacements, 12.6% lead revisions, 13.0% generator and lead interventions, 6.9% system upgrades and 22.8% reburial procedures. The timing of complication intervention varied significantly (Figure 1).

Timing of Complication Intervention

Conclusion

Complications within the first year of any cardiac implantable electronic device intervention is common, particularly system reburials, lead revisions and generator and lead procedures. 10% of complications after generator replacement, system upgrades or reburial procedures occurred at between 36–52 weeks. For lead and combined generator and lead procedures this figure rose to approximately 15%.
2407Influence of transvenous lead extraction procedure on function of tricuspid apparatus
Authors: Polewczyk A , Nowosielecka D , Tomaszewski A , Brzozowski W , Szczesniak Stanczyk D , Tulecki L , Tomkow K , Czajkowski M , Jachec W , Kutarski A
Published: October 2019

Background

Accidental damage of tricuspid apparatus remain known complication of TLE procedure but our knowledge is limited due lack of separate analysis in the literature.

Purpose

The goal of this study was analysis of the appearance of lead extraction related tricuspid valve dysfunction using trans-chest and trans-oesophageal echocardiography.

Methods

Between March 2006 and December 2018 we performed 2900 TLE procedures using conventional mechanical sheaths in 1760 male and 1140 female patients (mean age 66.6y). 4811 leads (mean implant duration 91.5 months) were removed due to non-infective indications in 65.3%. Full radiological success was obtained in 95.7% procedures, partial in 4.0%, clinical success in 98.0%, full procedural success in 96.1%. Major complications (MC) appeared in 8 (1.8%).

Results

Results are presented in the table

Conclusions

TLE using conventional mechanical sheaths is effective. Tricuspid valve dysfunction different degree is frequent finding in candidates for TLE. TLE procedure brings risk (7.2%) of different degree damage of tricuspid leflet (significant in 1.5%) or even chordae tendinae (4%). Patients with severe lead extraction related tricuspid valve dysfunction needs exact follow-up and some of them can be candidates for cardiac surgery. On the other hand in not so rare cases of lead related tricuspid valve dysfunction – lead removal/replacement can to bring improvement of tricuspid valve function (6.1%).