bluuebunny/crossref_metadata_2025_split huggingface dataset:
Infective endocarditis after transcatheter or surgical aortic valve implantation: pooled results from three randomized controlled trials
Authors: Lanz J , Popma J , Reardon M , Pilgrim T , Stortecky S , Deeb M , Yakubov S , Windecker S 
Published: November 2020

Abstract

Background
Infective endocarditis is a rare complication of aortic valve replacement with high morbidity and mortality. Data of randomized trials comparing the incidence and outcomes between surgical (SAVR) and transcatheter aortic valve replacement (TAVR) are scarce.

Purpose
To compare the frequency, timing and outcomes of infective endocarditis after TAVR and SAVR from 3 prospective randomized trials and examine the clinical outcomes.

Methods
Clinical data from the CoreValve Pivotal High-Risk, the intermediate-risk SURTAVI and the Evolut Low Risk randomized trials, which compared TAVR with a supra-annular, self-expanding transcatheter valve to SAVR, was pooled. Cases of infective endocarditis were independently adjudicated based on Duke's criteria necessitating 2 major criteria, or 1 major and 3 minor criteria, or 5 minor criteria. Baseline clinical and procedural characteristics for patients with and without endocarditis were obtained. The cumulative incidence of endocarditis through 5 years after TAVR or SAVR was determined using death as a competing risk. Kaplan-Meier estimates of all-cause mortality and the composite of all-cause mortality or stroke through 2 years were calculated for both treatment groups.

Results
Among 2249 TAVR patients, 12 cases of endocarditis (0.5%) were documented and among 1828 SAVR patients, 21 (1.1%) over a mean follow-up time of 2.25±1.58 years. Baseline characteristics were well-balanced between the TAVR and SAVR patients with endocarditis. The cumulative incidence of endocarditis at 5 years was significantly different between the two groups (figure). The prevalence of diabetes was significantly higher in patients with endocarditis than in those without (57.6% vs. 34.2%, p=0.005). In endocarditis patients the rate of all-cause mortality was 39.4% for TAVR patients and 67.8% for SAVR patients at 2 years (log-rank p=0.133). The rates of all-cause mortality or stroke were 55.0% for TAVR and 64.6% for SAVR patients (log-rank p=0.078).

Conclusions
In this pooled analysis of three randomized trials comparing TAVR with a supra-annular, self-expanding bioprosthesis to SAVR, overall rates of endocarditis were low. The cumulative incidence of infective endocarditis at 5 years was lower in the TAVR group. Mortality after endocarditis was high.
Figure 1

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Medtronic
Randomized clinical trial comparing a rivaroxaban-based with an antiplatelet-based strategy for cerebral embolization after TAVR (EARTH TAVR)-a magnetic resonance imaging substudy of the GALILEO trial
Authors: Froehlich G.M , Falk V , Endres M , Stangl V , Woehrle J , Steinbeck L , Erbay A , Rudolph T , Geisler T , Leistner D , Nolte C , Hausler G , Fiebach J , Dangas G , Landmesser U 
Published: November 2020

Abstract

Background
Cerebral embolization in patients after Transcatheter Aortic Valve Replacement (TAVR) represents a serious complication, that was related to impaired bioprosthetic leaflet motion and new-onset atrial fibrillation (AFib).

Purpose
Hereafter we present the first randomized study comparing the effect of an anticoagulation plus antiplatelet with a dual antiplatelet antithrombotic treatment in patients after TAVR on cerebral embolizations as assessed by serial cerebral magnetic resonance imaging (MRI).

Methods
The Evaluation of Cerebral Thrombembolism After TAVR (EARTH - TAVR) study was conducted as an investigator initiated substudy of the multicenter, randomized, GALILEO study. After successful TAVR, patients without indication for chronic anticoagulation were randomly assigned to rivaroxaban 10mg plus acetylsalicylic acid 75–100mg once-daily or clopidogrel 75mg plus acetylsalicylic acid 75–100mg once-daily. Cerebral MRI scans were performed pre-TAVR as a baseline, post-TAVR (within 24–48 hours after TAVR) and 90 days after TAVR. The MRI protocol included diffusion-weighted (DWI) and fluid-attenuated inversion recovery (FLAIR) imaging. Cerebral embolic lesions were evaluated by an independent cerebral MRI core lab. The primary outcome measure of this study was the occurrence and extent of cerebral embolizations as measured by total volume of new ischaemic cerebral lesions.

Results
36 patients were enrolled in the EARTH and the GALILEO study. The DWI MRI scans revealed an increase of cerebral lesions and volume post-TAVR by a median of 4.75 (95% NBCI 2.1–8.9) and 0.26cm3 (95% NBCI 0.11–0.59). On FLAIR imaging, lesion number and volume increased by a median of 3 (95% NBCI 1.5–6) and 0.1 cm3 (95% NBCI 0.04–0.31). At the 90 days MRI scan, there was no statistically significant change in cerebral lesions, if compared to the post-TAVR scan, irrespective of the treatment arm.

Conclusion
Thromboembolic events occur largely in the periinterventional phase post TAVR. Thereafter, the risk for additional cerebral embolization is low. An additional rivaroxaban therapy beyond antiplatelet inhibition did not impact on cerebral thromboembolism.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Bayer Pharmaceuticals
Incidence, clinical impact and treatment outcomes of valve thrombosis after transcatheter mitral valve implantation
Authors: Kikoine J , Urena M , Brochet E , Nguyen C , Carrasco J.L , Ducrocq G , Fuchs A , Vahanian A , Iung B , Himbert D 
Published: November 2020

Abstract

Background
Transcatheter mitral valve implantation (TMVI) is a new treatment option for high-risk surgical patients with degenerated bioprosthesis (ViV), failed annuloplasty rings (ViR) and severe mitral annular calcification (ViMAC). However, limited data exist on transcatheter heart valve thrombosis.

Purpose
The aim of this study was to report the incidence, clinical impact and treatment outcomes of transcatheter heart valve (THV) thrombosis in patients undergoing TMVI.

Methods
All consecutive patients undergoing TMVI in our center between July 2010 and September 2019 were included. A transoesophageal echocardiography and a computed tomography (CT) were performed before hospital discharge and at each clinical visit, at 3 months, at 1 year and yearly after. THV thrombosis was defined as the presence of at least one thickened leaflet with restricted motion suggestive of thrombus confirmed by TOE and/or contrast CT. All patients received anticoagulation therapy with vitamin K antagonists (VKA) and a low dose of aspirin for the first 3 months.

Results
A total of 132 patients underwent TMVI (62 ViV, 36 ViR and 34 ViMAC). Among them, 16 (12.1%) patients had a THV thrombosis. Median age was 67 years old and 56.2% of patients were women. Median time to diagnosis of THV thrombosis was 78 days. Early THV thrombosis was observed in 7 (43.7%) and in 13 (81.2%) patients THV thrombosis occurred within the first 6 months after the procedure. 8 out 9 patients with subacute or late THV thrombosis were not anticoagulated or with subtherapeutic anticoagulation. No stroke or thromboembolic events occurred in these patients. No change in mitral gradient was observed in 14 out 16 patients. VKA were indicated in all patients. THV thrombosis resolved in all but one patient.

Conclusion
THV thrombosis is frequent after TMVI, occurs mainly within the first 6-months after the procedure, are mostly subclinical and resolves after optimization of anticoagulation treatment. An anticoagulation therapy for at least 6 months may be necessary.
Timing of THV thrombosis

Funding Acknowledgement
Type of funding source: None
Long term survival in high-risk patients after percutaneous mitral leaflet repair in a single centre: comparable mortality regardless of aetiology
Authors: Connolly L , Rajani P , M-Labbe B , Davies A , Duncan A , Vazir A , Smith R 
Published: November 2020

Abstract

Background
Percutaneous mitral leaflet repair (PMVR) is a safe and effective alternative to conventional surgery in high-risk patients with both degenerative (DMR) and functional (FMR) mitral regurgitation. We present an analysis of a large cohort of consecutive patients treated with PMVR at a high-volume UK centre.

Purpose
We sought to analyse the outcomes of a group of patients undergoing PMVR over a 7-year period at a single centre, where surgery had been excluded. We hypothesised that the long-term mortality in this group would be high and would differ depending on the aetiology of MR.

Methods
We identified 246 consecutive patients over the duration of the PMVR programme, where follow up and pre-procedural data were available. We collected baseline characteristics including age at procedure, left ventricular ejection fraction (LVEF), left ventricular indexed diastolic volumes (LVEDVi) and aetiology of MR. Post procedural data included MR at end of procedure, all-cause mortality and duration of follow up.

Results
Baseline characteristics for the group, as a whole, were as follows: mean age 76±11 years, 170 (69%) male, DMR 136 (55%) vs. FMR 110 (45%), LVEF 49±15%. Baseline data by aetiology subgroup: mean age DMR 80±9 vs. FMR 71±11 (p&lt;0.001), LVEF DMR 58±10 vs. FMR 40±14 (p&lt;0.001), LVEDVi DMR 71±25 FMR 85±25 (p&lt;0.001). 99% of patients were treated with the MitraClip® device (Abbott, US), 1% received the Pascal device (Edwards, US). Post-procedural MR grade was similar for both groups (DMR 1.5±0.8 vs. 1.4±0.8, p=NS). Overall procedural mortality was 0.4% and at a mean follow up of 1097 days (median 1021, IQR 289–1555) was 30.8%. Mortality was identical regardless of aetiology (DMR 30.9% vs. FMR 30.8%, p=NS).

Conclusions
This analysis of consecutive “real world” patients demonstrates encouraging survival outcome at a mean of 3 years after PMVR, regardless of MR aetiology. DMR patients tended to be older but with lower LVEDVi and significantly higher LVEF. These data compare favourably with the published literature, where mortality for mixed and similarly high-risk populations at 12 months averages approximately 20–25%. Mortality in our FMR group at 3 years was also similar to that seen in the recently published COAPT study at 2 years. We have demonstrated that PMVR is a safe option for our cohort of unselected high-risk patients presenting with either degenerative or functional MR. We hypothesise that the absence of survival difference could relate to the younger age of FMR patients despite the significantly lower baseline LVEF and higher ventricular volumes. This analysis encourages the more routine use of PMVR for FMR in the UK, where currently only DMR is commissioned.

Funding Acknowledgement
Type of funding source: None
Prior surgical mitral commissurotomy and echocardiographic score influence in mitral balloon valvuloplasty. Immediate post procedure results
Authors: Aragao I , Peixoto E.C.S , Peixoto R.T.S , Peixoto R.T.S , Dos Anjos I.L.P.B , Bandeira L.L.B , Macedo T.L.S , Dos Santos S.C.M , Santos C.T , Machado R.F.S , Aragao A.A.B 
Published: November 2020

Abstract

Introduction
Percutaneous mitral balloon valvuloplasty is effective in mitral stenosis. Objectives: to evaluate prior mitral surgical commissurotomy (PMC) and echocardiographic score (ES) in the results and complications of mitral balloon valvuloplasty (MBV).

Methods
From 1987 to 2013, 526 procedures with Inoue balloon, double or single Balt balloon technique; 480 without PMC named primary MBV group (PMBVG) and 46 that have been submitted to PMC, the PMC group. The PMCG was older than PMBVG (42.7±12.4 vs 36.9±12.5 years, p=0.0030). Gender, atrial fibrilation and NYHA functional class were similar. In PMBVG and PMCG, respectively, ES were 7.2±1,4 and 7.7±1.5 points (p=0.0158) and mitral valve area (MVA) 0.94±0.21 and 1.00±0.22 cm2 (p=0.0699).

Results
Pre-MBV: mean pulmonary artery pressures (MPAP) were 37.8±14.2 and 37.6±14.4 mmHg, p=0.9515; mean gradient (MG) 19.6±6.9 and 18.3±6.9 mmHg, p=0.2342; MVA 0.90±0.21 and 0.93±0.19 cm2, p=0.4092, respectively, whem compare PMBVG and PMCG. Post-MBV: MPAP were 26.8±10.2 and 26.6±10.9 mmHg, p=0.9062; MG 5.4±3.5 and 6.3±4.2 mmHg, p=0.1492; MVA 2.04±0.42 and 1.92±0.41 cm2, p=0.0801, respectively. Mitral regurgitation (MR) were similar pre and post-MBV. Severe MR post-MBV in 10 patients: 8 in PMBVG and 2 in PMCG, p=0.2048. As there were not found significant diferences, the total group were divided in ES ≤8 and &gt;8 groups: Pre-MBV: MPAP 37.5±13.9 and 39.3±16.6 mmHg, p=0.4041; MG 19.7±6.8 and 18.3±7.3 mmHg, p=0.1753; MVA 0.90±0.21 and 0.94±0.20 cm2, p=0.0090 respectively. Post-MBV: MPAP 26.7±10.1 and 28.0±10.6 mmHg, p=0.3730, MG 5.5±3.6 and 5.5±3.3 mmHg, MVA 2.06±0.42 and 1.90±0.40 cm2, p=0.0090.

Conclusion
The groups with and without prior mitral commissurotomy in MBV were compare and no differences were found in pre- and post-procedure, as mean pulmonary artery pressure, mean mitral gradient, mitral valve area, and mitral regurgitation. Although PMCG was older, with higher ES, its hemodynamics datas were similar. Whem the entire group was divided based on echo scores, those with echo scores &gt;8 had highse MV (p=0.0090). and smaler mitral valve areas post-valvuloplasty. The valve anatomy were more important than prior commissurotomy.

Funding Acknowledgement
Type of funding source: None
Acute hemodynamic effects of iatrogenic inter-atrial shunts after percutaneous edge-to-edge mitral valve repair
Authors: Koschutnik M , Goliasch G , Nitsche C , Kammerlander A.A , Dona C , Dannenberg V , Schneider M , Bartko P , Mora B , Bartunek A , Andreas M , Hengstenberg C , Mascherbauer J 
Published: November 2020

Abstract

Background
Implantable interatrial shunt devices improve pulmonary vascular function in patients with heart failure by transferring richly oxygenated blood to the right heart. Whether iatrogenic atrial septum defects (iASDs) after percutaneous edge-to-edge mitral valve repair (pMVR) are also associated with beneficial hemodynamic effects has not been investigated.

Methods
We consecutively enrolled patients with relevant functional (FMR) and degenerative mitral regurgitation (DMR) scheduled for pMVR. Invasive hemodynamic assessments were performed prior to and immediately after the procedure.

Results
97 consecutive patients (75.4±9.1 years; 58% female) were prospectively included, 65 (66%) presented with relevant FMR. At baseline when compared to the DMR group, FMR was associated with worse left ventricular (LV) function (LV ejection fraction: 39 vs. 49%; p=0.001), higher NT-proBNP levels (7404 vs. 5214 pg/mL; p=0.023), worse renal function (serum creatinine: 1.7 vs. 1.3 mg/dL; p=0.019), and higher usage of spironolactone (68 vs. 42%; p=0.018) and sacubitril/valsartan (33 vs. 0%; p&lt;0.001).
Following pMVR, cardiac output (CO) and systemic blood flow (Qs) increased significantly (CO: 4.6 to 5.5 L/min; p&lt;0.001; Qs: 4.9 to 5.8 L/min; p=0.002), with more pronounced changes in the FMR subgroup (ΔCO: 1.0 vs. 0.6 L/min; Figure 1A; ΔQs: 1.2 vs. 0.1 L/min), when compared to DMR. Pulmonary blood flow (Qp) increased by 26% (4.3 to 5.4 L/min; p=0.008), accompanied by a raise in pulmonary artery (PA) oxygen (O2) saturation from 73 to 77% (p&lt;0.001). Arterial O2 saturation levels remained unchanged (98.3 to 98.7%; p=0.165), confirming no significant changes in systemic oxygenation. These changes were associated with a slight decline in pulmonary vascular resistance (PVR: 250 to 225 dynes*sec/cm5; p=0.369, Figure 1B), and a tendency towards improvement of pulmonary compliance (PAC: 3.6 to 4.0 mL/mmHg; p=0.414).

Conclusions
Invasively measured CO, Qs, Qp, and mixed-venous PA O2 saturation increased immediately after pMVR, alongside with potentially beneficial effects on pulmonary vasculature with marked improvements in PVR and PAC. These changes were more pronounced in the FMR subgroup. Further studies are required to assess long-term hemodynamic effects and underlying mechanisms of persistent iASDs on pulmonary vascular function.
Figure 1. Invasive hemodynamics

Funding Acknowledgement
Type of funding source: None
Percutaneous mitral balloon valvuloplasty. Single versus Inoue balloon. long term follow-up
Authors: Aragao I , Peixoto E.C.S , Peixoto R.T.S , Peixoto R.T.S , Dos Anjos I.L.P.B , Macedo T.L.S , Dos Santos S.C.M , Santos C.T , Machado R.F.S , Bandeira L.L.B 
Published: November 2020

Abstract

Introduction
The single balloon (SB) is the less expensive technique to perform mitral balloon valvuloplasty (MBV). Objectives: This study aimed to demonstrate that MBV with the Balt single (BSB) and Inoue ballon, the wordwire accepted technique, had similar outcome and long-term follow-up (FU).

Methods
From 1987 to 2013, 526 procedures were performed, being 312 with a FU, 56 (17,9%) with Inoue balloon (IB) and 256 (82,1%) with BSB. The mean FU 156±144 months, p&lt;0.0001. Univariate analysis (UA) and multivariate Cox analysis (MCA) to determine independent predict variables of survival and event free survival (EFS) of death, cardiac surgery and new MBV, in both techniques groups.

Results
In IB and BSB groups there were, respectively: female 42 (75.0%) and 222 (86.7%); mean age 37.3±10.0 (19 to 63) and 38.0±12.6 (13 to 83) years, p=0.7138; sinus rhythm 51 (91.1%) and 215 (84.0%), p=0.1754; echo score (ES) 7.6±1.3 (5 to 10) and 7.2±1.5 (4 to 14) points, p=0.0528; echo mitral valve area (MVA) pre-MBV 0.96±0.18 and 0.93±0.21 cm2, p=0.2265; post-MBV mean MVA (Gorlin) were 2.00±0.52 and 2.02±0.37 cm2, p=0.9554; MBV dilatation área 6,09±0,27 and 7,02±0,30, p&lt;0,0001. At the end of the FU, there were in IB and BSB groups, respectively: echo MVA 1.71±0.41 and 1.54±0.51 cm2, p=0.0552; new severe mitral regurgitation in 5 (8.9%) and 17 (6.6%) patients, p=0.5633; new MBV in 1 (1.8%) and 13 (5.1%), p=0.4779; mitral valve surgery in 3 (5.4%) and 27 (10.4%), p=0.3456; deaths 2 (3.6%) and 11 (4.3%), p=1.000; cardiac deaths 1 (1.8%) and 9 (3.5%), p=1.000; ME 5 (8.9%) and 46 (18.0%), p=0.1449. In UA and MCA the BSB or IB technique do not predict survival or EFS. The independent risk factors to survival were: age &lt;50 years (p=0.016, HR=0.233, 95% IC 0.071- 0.764), ES ≤8 (p&lt;0.001, HR=0.105, 95% IC 0.34–0.327), MBV dilatation area (p&lt;0.001, HR 16.838, 95% IC 3.353–84.580) and no mitral valve surgery in the FU (p=0.001, HR0.152, 95% IC 0.050–0.459). Independent risk factors to EFS: no prior commissurotomy (p=0.012, HR=0.390, 95% IC 0.187–0.813) and post-MBV MVA ≥1.50 cm2 (p=0.001, HR=7.969, 95% IC 3.413–18.608).

Conclusion
In 25 years, survival and EFS were similar in BSB and IB technique. Independent predictors of surviva: age &lt;50 years, ES≤8 points, MBV dilatation area &gt;7 mm2 and no mitral valve surgery in the FU. Independent predictors of EFS: no prior commissurotomy and post-MBV MVA≥1.50 cm2

Funding Acknowledgement
Type of funding source: None
Impact of left atrial appendage closure on left atrial hemodynamics: a prospective single center study
Authors: Mertens E , Bouziri N , Guedeney P , Duthoit G , Redheuil A , Ceccaldi A , Chicheportiche T , Isnard R , Silvain J , Montalescot G , Hammoudi N 
Published: November 2020

Abstract

Background
Percutaneous left atrial (LA) appendage closure is increasingly used to prevent strokes in patients with atrial fibrillation (AF). While LA appendage plays a key role in LA physiology, data regarding the impact of LA appendage occlusion on LA hemodynamics are lacking. The alteration of LA compliance by LA appendage occlusion may represent a clinical issue in AF patients which are at high risk of heart failure.

Purpose
To describe the impact of LA appendage occlusion on LA hemodynamics.

Material and methods
From july 2015 to january 2020, all patients undergoing LA occlusion procedure at Pitié-Salpêtrière Hospital (Paris, France) in whom LA pressure curves were recorded, before and immediately after device implantation, were included. The LA mean pressure was measured at baseline and after LA appendage occlusion during the same procedure. Abnormal LA mean pressure was defined as &gt;15mmHg. We also recorded cardiovascular death and hospitalization for congestive heart failure at longest follow-up.

Results
We enrolled 85 patients (78±8 years, 46 men), the CHA2DS2-VASc score was 5±1 and the HAS-BLED score was 4±1. The mean LA volume index was 51±15mL/m2, the left ventricular ejection fraction was 60±7%. The LA mean pressure increased significatively after LA appendage closure from 12.6±3.9mmHg to 15.5±5.2mmHg (p&lt;0.0001, Figure). The prevalence of abnormal LA pressure was 20% (17/85) at baseline and 45% (38/85) after LA appendage closure (p=0.005). Post procedural LA pressure elevation was not related to procedure duration nor to fluid expansion volume.
During a median follow-up of 364 [124–726] days, 3 (3.5%) patients died from a cardiovascular cause. Hospitalization for heart failure occurred in 6 (16%) of the 38 patients with abnormal postprocedural LA pressure, whereas no congestive episode was observed in the rest of the study population (p=0.006).

Conclusion
Catheter-based LA appendage occlusion induces an acute alteration of LA hemodynamics. Post procedural abnormal LA pressure may be linked to heart failure episodes in some patients. Further studies are warranted to investigate heart failure as a potential late complication of LA appendage closure.
Variations of mean LA pressure

Funding Acknowledgement
Type of funding source: None
Outcomes after coronary artery bypass graft surgery: systematic review and meta-analysis comparing bilateral versus single internal thoracic artery grafts
Authors: Stefil M , Gaudino M , Benedetto U , Gray A , Gerry S , Lees B , Krzych L , Seevanayagam S , Taggart D , Flather M 
Published: November 2020

Abstract

Background
Patients with diabetes and/or obesity are at higher risk of adverse outcomes following coronary artery bypass grafting (CABG). The use of bilateral internal thoracic arteries (BITA) can potentially offer survival benefit in higher risk patients compared to single internal thoracic artery (SITA) in patients undergoing CABG, but the overall evidence base for BITA has not influenced guidelines, and there are concerns over increased risk of sternal wound complications.

Methods
We conducted a systematic review of the literature to identify observational studies and randomised controlled trials (RCT) comparing the efficacy (mortality) and safety (sternal wound infection) of BITA and SITA in diabetic and obese patients.

Results
We identified 18 observational studies and one RCT to obtain data comparing BITA and SITA in 19,589 diabetic patients, and two observational studies and one RCT comparing BITA and SITA in 6972 obese patients. Pooled analysis demonstrated significant mortality benefit of BITA compared to SITA in diabetic patients (risk ratio [RR] 0.79; 95% confidence interval [CI] 0.70, 0.90; Z=3.62, p=0.0003; I2=88%) (Figure 1a). Pooled analysis in obese patients found no significant difference in mortality rates between BITA and SITA (RR 0.73, 95% CI 0.47, 1.12; Z=1.43, p=0.15; I2=78%) (Figure 1b). A significantly higher rate of sternal wound complications following BITA was observed in diabetic (RR 1.53, 95% CI 1.23, 1.90; Z=3.86, p=0.0001; I2=4%) and obese patients (RR 2.24, 95% CI 1.63, 3.07; Z=5.00, p&lt;0.00001; I2=0%).

Conclusions
BITA is associated with better long-term survival in diabetic patients, but most of the supportive data comes from observational studies. The effects of BITA grafting in patients who are obese is uncertain due to low numbers. BITA is associated with higher rates of sternal wound complications than SITA in both diabetic and obese patients. Further research is needed to understand if BITA has a role in higher risk patients undergoing CABG.
Figure 1. Pooled all-cause mortality

Funding Acknowledgement
Type of funding source: None