Publications by authors named "Horst Sievert"

352 Publications

Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE-FMR trial.

ESC Heart Fail 2021 Feb 22. Epub 2021 Feb 22.

Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.

Aims: The objective of this study was to compare functional outcomes through 1 year in patients with core-lab verified moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control in the blinded sham-controlled REDUCE-FMR (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation) study.

Methods And Results: The main outcomes of this analysis were the change in 6 min walk test (6MWT) distance, incidence of heart failure hospitalization or death, change in New York Heart Association (NYHA) class, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 1 year of follow-up. The minimum clinically important difference (MCID) was defined as a ≥30 m increase in 6MWT distance, an NYHA decrease in ≥1 class, and a ≥3 point increase in KCCQ score. The proportion of patients achieving the MCID in each treatment group was compared using Fisher's exact test, and the number needed to treat (NNT) with the Carillon device was calculated. Among 83 patients (62 Carillon and 21 sham), no statistically significant group differences were observed in the baseline characteristics. All outcomes at 1 year numerically favoured the Carillon group, including MCID for the 6MWT distance (59% vs. 23%, P = 0.029; NNT = 2.8), NYHA class (48% vs. 33%, P = 0.38; NNT = 6.9), KCCQ score (69% vs. 47%, P = 0.14; NNT = 4.5), and freedom from heart failure hospitalization or death (60% vs. 48%, P = 0.45; NNT = 8.3).

Conclusions: REDUCE-FMR was the first blinded sham-controlled trial to report outcomes with percutaneous therapy for the treatment of FMR. Trends towards improvement in mean 6MWT distance, KCCQ score, and NYHA class were observed with the Carillon device. A substantially higher number of patients achieved MCID for all patient-centred outcomes with the Carillon device compared with the sham procedure.
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http://dx.doi.org/10.1002/ehf2.13273DOI Listing
February 2021

Transcatheter Tricuspid Valve Intervention in Patients with Previous Left Valve Surgery.

Can J Cardiol 2021 Feb 19. Epub 2021 Feb 19.

Cardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada. Electronic address:

Background: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI).

Objectives: This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI.

Methods: This was a sub-analysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively.

Results: Patients with PLVS were younger (72±10 vs. 78±9 years, p <0.01) and more frequently women (67.1% vs 53.2%, p = 0.02). Similar rates of procedural success (PLVS: 80.5%, no-PLVS: 82.1%, p=0.73), and 30-day mortality (PLVS:2.4%, no-PLVS:3.4% , p=0.99 ) were observed. After matching, there were no significant differences in both all-cause rehospitalization (PLVS: 21.1%, non-PLVS: 26.5%, p=0.60) and all-cause mortality (PLVS: 9.8%, non-PLVS: 6.7%, p=0.58). At last follow-up (median time 5.7 [1.4-11.9] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA class I-II (p= 0.12 vs. no-PLVS group), and TR grade was ≤2 in 82.6% of patients (p= 0.096 vs. no-PVLS group).

Conclusions: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one third of patients required rehospitalization or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo-surgery in patients with PLVS, and suggest the importance of earlier treatment in order to improve clinical outcomes.
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http://dx.doi.org/10.1016/j.cjca.2021.02.010DOI Listing
February 2021

One-year results of the first-in-man study investigating the Atrial-Flow-Regulator for left-atrial shunting in symptomatic heart failure patients: the PRELIEVE study.

Eur J Heart Fail 2021 Feb 8. Epub 2021 Feb 8.

Department of Internal Medicine, Cardiology, Angiology and Intensive Care Medicine, University Clinic Saarland, Homburg, Germany.

Aims: Attenuating exercise-induced elevated left atrial pressure (LAP) with an atrial shunt device is under clinical investigation for treatment of symptomatic heart failure (HF).

Methods And Results: PRELIEVE was a prospective, non-randomized, multi-center, first-in-man study in symptomatic HF patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction and pulmonary capillary wedge pressure (PCWP) ≥15mmHg at rest or ≥25mmHg during exercise. Here, we provide follow-up data up to one year after implantation of the Atrial Flow Regulator (AFR). The AFR was successfully implanted in 53 patients (HFrEF n=24 and HFpEF n=29). Two patients were not enrolled due to an unsuccessful transseptal puncture. There was one device embolization into the left atrium, which required surgical removal. One patient experienced a serious procedure-related adverse event (postprocedural bleeding and syncope). All patients with sufficient echocardiography-readout confirmed device patency with left-right shunt both at three (n=47/51, 92%) and 12 (n=45/49, 92%) months. At three months, rest-PCWP decreased by 5 (-12, 0) mmHg (p=0.0003, median (Q1, Q3). No patient developed a stroke, worsening of right heart function or significant increase of the pulmonary artery pressure. Six (6/53, 11%) patients were hospitalised for worsening of HF and three (3/53, 6%) patients died. We observed improvements in functional NYHA class, 6-minute walking distance and quality of life (KCCQ) in certain patients.

Conclusions: Implantation of the AFR device in HF patients was feasible. No shunt occlusion, stroke or new right HF was observed during the one-year follow-up, with clinical improvements in certain patients.
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http://dx.doi.org/10.1002/ejhf.2119DOI Listing
February 2021

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

Circ Cardiovasc Interv 2021 Feb 5;14(2):e009685. Epub 2021 Feb 5.

Cardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (G.M.-C., F. Philippon, R.P., J.R.-C.).

Background: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients.

Methods: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg.

Results: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, <0.001).

Conclusions: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009685DOI Listing
February 2021

Interdisciplinary management of acute ischaemic stroke: Current evidence training requirements for endovascular stroke treatment: Position Paper from the ESC Council on Stroke and the European Association for Percutaneous Cardiovascular Interventions with the support of the European Board of Neurointervention.

Eur Heart J 2021 Jan;42(4):298-307

Cardiocenter, Third Faculty of Medicine, Charles University, Prague, Czech Republic.

This ESC Council on Stroke/EAPCI/EBNI position paper summarizes recommendations for training of cardiologists in endovascular treatment of acute ischaemic stroke. Interventional cardiologists adequately trained to perform endovascular stroke interventions could complement stroke teams to provide the 24/7 on call duty and thus to increase timely access of stroke patients to endovascular treatment. The training requirements for interventional cardiologists to perform endovascular therapy are described in details and should be based on two main principles: (i) patient safety cannot be compromised, (ii) proper training of interventional cardiologists should be under supervision of and guaranteed by a qualified neurointerventionist and within the setting of a stroke team. Interdisciplinary cooperation based on common standards and professional consensus is the key to the quality improvement in stroke treatment.
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http://dx.doi.org/10.1093/eurheartj/ehaa833DOI Listing
January 2021

European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

Eur Heart J 2021 Jan 28. Epub 2021 Jan 28.

Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.
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http://dx.doi.org/10.1093/eurheartj/ehaa1070DOI Listing
January 2021

European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

EuroIntervention 2021 01 28. Epub 2021 Jan 28.

S. Filippo Neri Hospital ASL Roma 1, Rome, Italy.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.
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http://dx.doi.org/10.4244/EIJ-D-20-00785DOI Listing
January 2021

Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry.

Catheter Cardiovasc Interv 2021 Jan 8. Epub 2021 Jan 8.

Cardiology Department, St Antonius Hospital, Nieuwegein, the Netherlands.

Background: In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device-related thrombus in a large multi-center real-world cohort undergoing LAAc with the WATCHMAN device.

Methods And Results: We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74 ± 9 y/o and were at high risk for stroke and bleeding (CHA2DS2-VASC-Score 4.3 ± 1.7; HAS-BLED-Score 2.3 ± 1.2). Device-related thrombus was detected in 4.1% (34/835) after a median of 54 days (IQR 42-111 days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long-standing, non-paroxysmal atrial fibrillation (82.4 vs. 64.9%, p < .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p = .03) and larger LAA diameters at the ostium (22.8 ± 3.5 vs. 21.1 ± 3.5 mm, p < .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non-paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No-DRT 2.2%/year, p = .8).

Conclusions: In real-world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post-procedural regimen and was not associated with an increased risk of stroke or SE. While long-standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.
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http://dx.doi.org/10.1002/ccd.29458DOI Listing
January 2021

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

J Am Coll Cardiol 2021 Jan;77(1):1-14

Centres for Heart Valve and Cardiovascular Innovation, St. Paul's and Vancouver General Hospital, Vancouver, British Columbia, Canada. Electronic address:

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.

Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).

Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.

Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm vs. 1.37 ± 0.5 cm; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).

Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
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http://dx.doi.org/10.1016/j.jacc.2020.10.053DOI Listing
January 2021

Imaging for Native Mitral Valve Surgical and Transcatheter Interventions.

JACC Cardiovasc Imaging 2021 Jan;14(1):112-127

Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.

There has been rapid progress in transcatheter therapies for mitral regurgitation. These developments have elevated the need for the imager to have a core understanding of the functional mitral valve anatomy. Pre- and intraoperative echocardiography for surgical mitral valve repair for mitral regurgitation has defined contemporary interventional imaging in many ways. The central tenets of these principles apply to interventional imaging of transcatheter mitral valve interventions. However, the heightened emphasis on procedural planning and procedural imaging is one of the new challenges posed by transcatheter interventions. This need for accurate and reliable information has required the imager to be agnostic to the imaging modality. Cardiac computed tomography has become critical in procedural planning in this new paradigm. The expanded use of pre-procedural cardiac magnetic resonance to quantify mitral regurgitation and characterize the left ventricle is another illustration of this newer approach. Other illustrations of the new world of interventional imaging include the expanded use of 3-dimensional (3D) transesophageal echocardiography and real-time fusion of echocardiography and fluoroscopy images. Imaging data are also the basis for computational modeling, 3D printing, and artificial intelligence. These technologies are being increasingly explored to improve therapy selection and prediction of procedural outcomes. This review provides an update of the essentials in present interventional imaging for surgical and transcatheter interventions for mitral regurgitation.
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http://dx.doi.org/10.1016/j.jcmg.2020.11.021DOI Listing
January 2021

Predictors of high residual gradient after transcatheter aortic valve replacement in bicuspid aortic valve stenosis.

Clin Res Cardiol 2021 Jan 3. Epub 2021 Jan 3.

Interventional Cardiology Unit, GVM Care and Research, Maria Cecilia Hospital, via della Corriera 1, 48033, Cotignola, Ravenna, Italy.

Objectives: To define the incidence of high residual gradient (HRG) after transcatheter aortic valve replacement (TAVR) in BAVs and their impact on short term outcome and 1-year mortality.

Background: Transcatheter heart valves (THVs) offer good performance in tricuspid aortic valves with low rate of HRG. However, data regarding their performance in bicuspid aortic valves (BAV) are still lacking.

Methods: The BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry included 353 consecutive patients who underwent TAVR (Evolut R/PRO or Sapien 3 valves) in BAV between June 2013 and October 2018. The primary endpoint was device unsuccess with post-procedural HRG (mean gradient ≥ 20 mmHg). The secondary endpoint was to identify the predictors of HRG following the procedure.

Results: Twenty patients (5.6%) showed HRG after TAVR. Patients with HRG presented higher body mass index (BMI) (30.7 ± 9.3 vs. 25.9 ± 4.8; p < 0.0001) and higher baseline aortic mean gradients (57.6 ± 13.4 mmHg vs. 47.7 ± 16.6, p = 0.013) and more often presented with BAV of Sievers type 0 than patients without HRG. At multivariate analysis, BMI [odds ratio (OR) 1.12; 95% confidence interval (CI) 1.05-1.20, p = 0.001] and BAV type 0 (OR 11.31, 95% CI 3.45-37.06, p < 0.0001) were confirmed as independent predictors of high gradient.

Conclusion: HRG following TAVR in BAVs is not negligible and is higher among patients with high BMI and with BAV 0 anatomy.
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http://dx.doi.org/10.1007/s00392-020-01793-9DOI Listing
January 2021

Transcatheter Treatment of Residual Significant Mitral Regurgitation Following TAVR: A Multicenter Registry.

JACC Cardiovasc Interv 2020 Dec;13(23):2782-2791

Department of Cardiology, Rabin Medical Centre, Petach-Tikva, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Objectives: The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit.

Background: The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging.

Methods: This was an international registry of 23 TAVR centers.

Results: In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05).

Conclusions: For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274).
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http://dx.doi.org/10.1016/j.jcin.2020.07.014DOI Listing
December 2020

Interdisciplinary management of acute ischaemic stroke: Current evidence training requirements for endovascular stroke treatment.

Eur Heart J 2020 Nov 7. Epub 2020 Nov 7.

Cardiocenter, Third Faculty of Medicine, Charles University, Prague, Czech Republic.

This ESC Council on Stroke/EAPCI/EBNI position paper summarizes recommendations for training of cardiologists in endovascular treatment of acute ischaemic stroke. Interventional cardiologists adequately trained to perform endovascular stroke interventions could complement stroke teams to provide the 24/7 on call duty and thus to increase timely access of stroke patients to endovascular treatment. The training requirements for interventional cardiologists to perform endovascular therapy are described in details and should be based on two main principles: (i) patient safety cannot be compromised, (ii) proper training of interventional cardiologists should be under supervision of and guaranteed by a qualified neurointerventionist and within the setting of a stroke team. Interdisciplinary cooperation based on common standards and professional consensus is the key to the quality improvement in stroke treatment.
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http://dx.doi.org/10.1093/eurheartj/ehaa833DOI Listing
November 2020

Early Multinational Experience of Transcatheter Tricuspid Valve Replacement for Treating Severe Tricuspid Regurgitation.

JACC Cardiovasc Interv 2020 Nov;13(21):2482-2493

Department of Surgical, Medical and Molecular Pathology and Critical Care, University of Pisa, Pisa, Italy.

Objectives: The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk.

Background: Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality.

Methods: Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected.

Results: At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events.

Conclusions: Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy.
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http://dx.doi.org/10.1016/j.jcin.2020.07.008DOI Listing
November 2020

Procedural and clinical outcomes of type 0 versus type 1 bicuspid aortic valve stenosis undergoing trans-catheter valve replacement with new generation devices: Insight from the BEAT international collaborative registry.

Int J Cardiol 2021 Feb 22;325:109-114. Epub 2020 Oct 22.

GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy; EMO GVM Centro Cuore Columbus, Milan, Italy.

Background: Although bicuspid aortic valve (BAV) is not considered a "sweet spot" to trans-catheter aortic valve replacement (TAVR), a certain number of BAV underwent TAVR. Whether BAV phenotype affects outcomes following TAVR remains debated. We aimed at evaluating the impact of BAV phenotype on procedural and clinical outcomes after TAVR using new generation trans-catheter heart valves (THVs).

Methods: patients included in the BEAT registry were classified according to the BAV phenotype revealed at multi-slice computed tomography (MSCT) in type 0 (no raphe) vs. type 1 (1 raphe). Primary end-point was Valve Academic Research Consortium-2 (VARC-2) device success. Secondary end-points included procedural complications, rate of permanent pacemaker implantation, clinical outcomes at 30-day and 1-year.

Results: Type 0 BAV was present in 25(7.1%) cases, type 1 in 218(61.8%). Baseline characteristics were well balanced between groups. Moderate-severe aortic valve calcifications at MSCT were less frequently present in type 0 vs. type 1 (52%vs.71.1%,p = 0.05). No differences were reported for THV type, size, pre and post-dilation between groups. VARC-2 success tended to be lower in type 0 vs. type 1 BAV (72%vs86.7%;p = 0.07). Higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 group (24%vs6%,p = 0.007). No differences were reported in the rate of post-TAVR moderate-severe aortic regurgitation and clinical outcomes between groups.

Conclusions: Our study confirms TAVR feasibility in both BAV types, however a trend toward a lower VARC-2 device success and a higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 BAV.
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http://dx.doi.org/10.1016/j.ijcard.2020.10.050DOI Listing
February 2021

Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system.

Clin Res Cardiol 2021 Mar 31;110(3):382-390. Epub 2020 Oct 31.

Head of Clinical Trial and Member of the Data Safety and Monitoring Board, Cardiological-Internal Practice, Hamburg, Germany.

Objective: This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm.

Background: The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects.

Methods: In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD.

Results: The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2-65) years and a median body weight of 26.7 (10-109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients).

Conclusion: The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.
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http://dx.doi.org/10.1007/s00392-020-01750-6DOI Listing
March 2021

A current and future outlook on upcoming technologies in remote monitoring of patients with heart failure.

Eur J Heart Fail 2020 Oct 27. Epub 2020 Oct 27.

Division of Cardiology and Metabolism - Heart Failure, Cachexia & Sarcopenia, Department of Cardiology, Campus Virchow-Klinikum, Charité - Medical School, Berlin, Germany.

Heart failure is a major health and economic challenge in both developing and developed countries. Despite advances in pharmacological and device therapies for patients with a reduced left ventricular ejection fraction (LVEF) and heart failure, their quality of life and exercise capacity are often persistently impaired, morbidity and mortality remain high and the health economic and societal costs are considerable. For patients with heart failure and preserved LVEF, diuretic management has an essential role for controlling congestion and symptoms, even if no intervention has convincingly shown to reduce morbidity or mortality. Remote monitoring might improve care delivery and clinical outcomes for patients regardless of LVEF. A great variety of innovative remote monitoring technologies and algorithms are being introduced, including patient self-managed testing, wearable devices, technologies either integrated into established clinically indicated therapeutic devices, such as pacemakers and defibrillators, or as stand-alone are in development providing the promise of further improvements in service delivery and clinical outcomes. In this article, we will discuss unmet needs in the management of patients with heart failure, how remote monitoring might contribute to future solutions, and provide an overview of current and novel remote monitoring technologies.
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http://dx.doi.org/10.1002/ejhf.2033DOI Listing
October 2020

Post-market clinical follow-up with the patent foramen ovale closure device IrisFIT (Lifetech) in patients with stroke, transient ischemic attack or other thromboembolic events.

Cardiovasc Revasc Med 2020 Sep 24. Epub 2020 Sep 24.

CardioVascular Center Frankfurt, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, United Kingdom. Electronic address:

Background: A patent foramen ovale (PFO) has been associated with embolic strokes and transient ischemic attacks (TIAs). Catheter closure of PFO is effective in preventing recurrent events. Residual shunts and procedure or device related complications can occur, including atrial fibrillation and thrombus formation. This study examines the initial experience with a new PFO closure device, the IrisFIT PFO-Occluder (Lifetech Scientific, Shenzhen, China).

Methods: 95 patients with indications for PFO closure underwent percutaneous closure with the IrisFIT PFO-Occluder. The primary endpoint was the rate of accurate device placement with no/small residual shunt at 3 or 6 months follow-up. All patients underwent transoesophageal echocardiography (TEE) after 1 to 6 months. In case of a residual shunt, an additional TEE was performed after 12 months. Clinical follow-up was performed up to a mean of 33.1 ± 3.6 months.

Results: The device was successfully implanted in 95 (100%) patients with no relevant procedural complications. At final TEE follow-up (7.6 ± 3.9 months) the effective closure rate was 96.8% with 1 moderate and 2 large residual shunts. There were 8 cases of new onset atrial fibrillation and 2 TIAs. There were no cases of device embolization or erosion.

Conclusion: The IrisFIT occluder is a new PFO closure device with several advantages compared to other devices. In this small study cohort, technical success rate, closure rate and adverse event rate were comparable to other devices. The rate of new onset atrial fibrillation was higher in comparison to other studies and warrants further investigation.
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http://dx.doi.org/10.1016/j.carrev.2020.09.031DOI Listing
September 2020

Deep Sedation versus General Anaesthesia for Transcatheter Mitral Valve Repair: An Individual-Patient Data Meta-analysis of Observational Studies.

EuroIntervention 2020 Oct 13. Epub 2020 Oct 13.

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, and Leipzig Heart Institute, Leipzig, Germany.

Aims: To compare general anaesthesia (GA) and deep sedation (DS) with regard to safety and length of intensive care unit (ICU) stay in patients undergoing percutaneous edge-to-edge mitral valve repair (PMVR).

Methods And Results: Four studies comparing GA and DS in patients undergoing PMVR were included in an individual patient data meta-analysis. Data were pooled after multiple imputation. The composite safety endpoint of all-cause death, stroke, pneumonia, or major to life-threatening bleeding occurred in 87 of 626 (13.9%) patients with no difference between patients treated with DS as compared to GA (56 and 31 events in 420 and 206 patients, respectively). In this regard, the odds ratio was 1.27 (95% confidence interval, 0.78 to 2.09; p = 0.338) and 1.26 (95% confidence interval, 0.49 to 3.22; p = 0.496) following the one-stage and two-stage approach, respectively. Length of ICU stay was longer after GA as compared to DS (ratio of days 3.08, 95% confidence interval, 2.18 to 4.36, p < 0.001 and 2.88, 95% confidence interval, 1.45 to 5.73, p = 0.016 following the one-stage and two-stage approach, respectively).

Conclusions: Both, DS and GA might offer a similar safety profile. However, ICU stay seems to be shorter after DS.
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http://dx.doi.org/10.4244/EIJ-D-20-00607DOI Listing
October 2020

Alcohol-mediated renal sympathetic neurolysis for the treatment of hypertension: The Peregrine™ infusion catheter.

Cardiovasc Revasc Med 2020 Sep 7. Epub 2020 Sep 7.

CardioVascular Center Frankfurt, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, UK. Electronic address:

Renal sympathetic denervation using conventional non-irrigated radiofrequency catheters has potential technical shortcomings, including limited penetration depth and incomplete circumferential nerve damage, potentially impacting therapeutic efficacy. Against this background, second generation multi-electrode, radiofrequency and ultrasound renal denervation systems have been developed to provide more consistent circumferential nerve ablation. Irrigated catheters may allow deeper penetration while minimizing arterial injury. In this context, catheter-based chemical denervation, with selective infusion of alcohol, a potent neurolytic agent, into the perivascular space, may minimize endothelial, intimal and medial injury while providing circumferential neurolysis. Animal studies demonstrate pronounced renal norepinephrine level reductions and consistent renal nerve injury after perivascular alcohol infusion using the Peregrine Catheter. Early clinical studies demonstrated significant blood pressure reductions and a reasonable safety profile. Randomized sham-controlled trials (NCT03503773, NCT02910414) are underway to examine whether the aforementioned theoretical advantages of alcohol-medicated denervation with the Peregrine System™ Kit translate into clinical benefits.
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http://dx.doi.org/10.1016/j.carrev.2020.09.003DOI Listing
September 2020

Comparison in Patients < 75 Years of Age - Versus - Those > 75 Years on One-year-Events With Atrial Fibrillation and Left Atrial Appendage Occluder (From the Prospective Multicenter German LAARGE Registry).

Am J Cardiol 2020 12 15;136:81-86. Epub 2020 Sep 15.

Klinikum Ludwigshafen, Ludwigshafen, Germany; Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.. Electronic address:

Left atrial appendage closure (LAAC) is an alternative to oral anticoagulation therapy in patients with non-valvular atrial fibrillation for the prevention of embolic stroke and systemic embolism. Although elderly patients (>75 years) have both higher ischemic and bleeding risk as compared with younger patients, they benefit from optimal anticoagulation. The subanalysis aimed to assess the indications, the safety, efficacy, and 1-year outcomes of interventional LAAC in elderly patients (≥ 75 years) compared with younger (< 75 years) patients in clinical practice. We analyzed data from the prospective Left-Atrium-Appendage Occluder Registry Germany. A total of 638 patients were included in the registry, 402 (63%) were aged ≥ 75 years. Compared with younger subjects, patients aged ≥75 were more likely to have higher CHA2DS2-VASC and HAS-BLED scores. Procedural success rate was high und similar in both groups (97.6%). Periprocedural adverse events were not statistically significant in groups (11.9% in <75 years vs 12.9% in ≥75 years; p = 0.80). At 1 year follow-up, all-cause mortality was higher in patients aged ≥75 compared withwith younger group (13.0% vs 7.8 %,p = 0.04), mainly due to non-cardiovascular causes (10.6% vs 6.0%). No significant differences in major bleeding, stroke, systemic embolism were observed. In conclusion, LAAC is feasible and safe in patients with AF at high stroke risk and with contraindications for OAC and should be considered as candidates for LAA closure. Elderly patients often present these characteristics and could benefit from this novel therapy.
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http://dx.doi.org/10.1016/j.amjcard.2020.09.017DOI Listing
December 2020

Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention.

JACC Cardiovasc Interv 2020 09;13(17):1999-2009

Department of Cardiac Surgery, University Hospital Zurich, Zurich, Switzerland. Electronic address:

Objectives: The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI).

Background: The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR.

Methods: The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year.

Results: Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048).

Conclusions: Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166).
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http://dx.doi.org/10.1016/j.jcin.2020.05.011DOI Listing
September 2020

CT-overlay hybrid imaging to facilitate Sentinel cerebral protection system deployment in the presence of an anomalous vertebral artery originating from the aortic arch during transcatheter aortic valve implantation.

Cardiovasc Revasc Med 2020 Jul 31. Epub 2020 Jul 31.

Minneapolis Veterans Affairs Medical Center, Minneapolis, MN, USA; University of Minnesota, Minneapolis, MN, USA; CardioVascular Center Frankfurt, Frankfurt, Germany. Electronic address:

Stroke remains an important risk during transcatheter aortic valve implantation (TAVI). Though the use of the double-filter Sentinel cerebral protection system (Boston Scientific, Marlborough, MA, USA) may lower the stroke risk, the deployment of this device requires manipulation within the aortic arch and cranial arch vessels potentially causing dislodgment of atherosclerotic debris in the process thereby possibly offsetting its benefit with regards to reducing cerebral embolization. Apart from patient selection, minimizing maneuvering during deployment may improve the safety of device deployment. In this context, we illustrate a case using three-dimensional computed tomography (CT) - overlay to facilitate Sentinel cerebral protection system deployment during TAVI. Emphasis in this case rests on demonstration of how aforementioned periprocedural imaging may facilitate negotiation of anatomical variants and avoid inadvertent cannulation of an anomalous left vertebral artery originating from the aortic arch. Imaging guidance with this concept may minimize device manipulation and reduce the risk of cerebral embolization. Further systematic evaluation is needed to demonstrate whether this approach improves clinical outcomes.
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http://dx.doi.org/10.1016/j.carrev.2020.07.034DOI Listing
July 2020

Mechanical thrombectomy for ischemic stroke: "time is brain" is a no-brainer.

Kardiol Pol 2020 08 25;78(7-8):801-802. Epub 2020 Aug 25.

CardioVascular Center Frankfurt (CVC), Sankt Katharinen Hospital, Frankfurt, Germany

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http://dx.doi.org/10.33963/KP.15567DOI Listing
August 2020

Outcomes following endovascular therapy for acute stroke by interventional cardiologists.

Catheter Cardiovasc Interv 2020 Nov 10;96(6):1296-1303. Epub 2020 Aug 10.

Department of Cardiology, Ochsner Clinical School, University of Queensland, St Lucia, Australia.

Objectives: To summarize the outcomes of acute ischemic stroke (AIS) intervention by interventional cardiologists (IC) working on a stroke team.

Background: There is a geographic maldistribution of dedicated neuro-interventionalists (NI) to treat large vessel occlusion (LVO) AIS.

Methods: Results of 166 consecutive patients who received endovascular therapy (EVT) for AIS due to LVO by IC at three centers between 2009 and 2019 are reported. A modified Rankin score (mRs) of ≤ 2 at 90 days after EVT was used as the primary measurement of a good neurological outcome. Univariate logistic regression was used to evaluate predictors of the mRS > 2 and mortality. Those variables with significance of p < .2 from the univariate analysis were included in a multivariate analysis.

Results: All-cause mortality at 30 days was 22%. A favorable clinical outcome, mRS ≤ 2 at 90 days, was 49%. After multivariate analysis and controlling for confounders, a higher baseline NIHSS was predictive of 30-day mortality (OR 1.20 [95% CI 1.09-1.32] p < .001) and unfavorable clinical outcome (mRS > 2) at 90 days (OR 1.16 [95% CI 1.07-1.25] p < .001).

Conclusion: Outcomes for carotid stent capable IC performing EVT for AIS are comparable to those achieved by NI physicians in major randomized clinical trials. Our data supports conducting a clinical trial of carotid stent capable IC working on multidisciplinary stroke teams to perform EVT for AIS due to LVO in communities and hospitals without timely access (<60 min by ground transport) to dedicated NI.
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http://dx.doi.org/10.1002/ccd.29180DOI Listing
November 2020

Transcatheter Mitral Valve-in-Ring Implantation in the Flexible Adjustable Attune Annuloplasty Ring.

Cardiovasc Revasc Med 2020 Nov 18;21(11S):54-59. Epub 2020 Jul 18.

University of Minnesota, Minneapolis, MN, USA; Minneapolis Veterans Affairs Medical Center, Minneapolis, MN, USA; CardioVascular Center Frankfurt, Frankfurt, Germany. Electronic address:

Transcatheter mitral valve-in-ring implantation (TMViR) poses unique challenges when compared to valve-in-valve implantation due to the large variation in the different annuloplasty rings used. Annuloplasty rings are often classified according to whether they are complete or incomplete, rigid, semi-rigid, or flexible, and whether their three-dimensional geometry is saddle-shaped or flat. A limited number of annuloplasty rings are available which are adjustable allowing the surgeon to increase or decrease the size of the ring once it has been sutured in place. To our knowledge there has been no description of TMViR in such adjustable complete rings and recommendations on THV sizing and implantation are not available on the Valve-in-Valve application. Here we report a case of TMViR in an adjustable annuloplasty ring (Attune ring, Abbott, Chicago, IL, USA) and review the literature on TMViR.
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http://dx.doi.org/10.1016/j.carrev.2020.07.011DOI Listing
November 2020

Balloon Versus Self-Expandable Valve for the Treatment of Bicuspid Aortic Valve Stenosis: Insights From the BEAT International Collaborative Registrys.

Circ Cardiovasc Interv 2020 07 10;13(7):e008714. Epub 2020 Jul 10.

GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy (A.M., F.G., A.L., F.G., A.C.).

Background: Large data comparing the performance of new-generation self-expandable versus balloon-expandable transcatheter heart valves in bicuspid aortic stenosis are lacking. We aim to compare the safety and performance of balloon-expandable and self-expandable transcatheter heart valves in the treatment of bicuspid aortic stenosis.

Methods: The BEAT (balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis) registry included 353 consecutive patients who underwent transcatheter aortic valve implantation using new-generation Evolut R/PRO or Sapien 3 valves in bicuspid aortic valve.

Results: A total of 353 patients (n=242 [68.6%] treated with Sapien 3 and n=111 [68.6%] treated with Evolut R (n=70)/PRO [n=41]) were included. Mean age was 77.8±8.3 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality was 4.4±3.3%. Valve Academic Research Consortium-2 device success was similar between Sapien 3 and Evolut R/PRO (85.6% versus 87.2%; =0.68). In the Sapien 3 group, 4 patients experienced annular rupture whereas this complication did not occur in the Evolut R/PRO group. After propensity score matching, Valve Academic Research Consortium-2 device success was similar between both groups (Sapien 3=85.7% versus Evolut R/Pro=84.4%; =0.821). Both in the overall and in the matched population, no differences in the rate of permanent pacemaker implant were observed. At 1-year follow-up, the rate of overall death and cardiovascular death were similar between the 2 groups. In the unmatched population, the 1-year echocardiographic follow-up demonstrated similar rate of moderate-to-severe paravalvular aortic regurgitation (Evolut R/PRO 10.5% versus Sapien 3 4.2%, =0.077); however, after propensity matching, the rate of moderate-to-severe paravalvular leak became significantly higher among patients treated with self-expandable valves (9.3% versus 0%; =0.043).

Conclusions: Our study confirms the feasibility of both Sapien 3 and Evolut R/PRO implantation in bicuspid aortic valve anatomy; a higher rate of moderate-severe paravalvular aortic regurgitation was observed in the Evolut R/PRO group at 1-year follow-up in the matched cohort, although patients treated with balloon-expandable valve had a higher rate of annular rupture.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008714DOI Listing
July 2020

Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN.

Europace 2020 07;22(7):1036-1043

CardioVascular Center CVC, Seckbacher Landstraße 65, 60389 Frankfurt, Germany.

Aims: Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study.

Methods And Results: A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy.

Conclusions: Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.
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http://dx.doi.org/10.1093/europace/euaa074DOI Listing
July 2020

WATCHMAN versus ACP or Amulet devices for left atrial appendage occlusion: a sub-analysis of the multicentre LAARGE registry.

EuroIntervention 2020 Dec 4;16(11):e942-e949. Epub 2020 Dec 4.

CardioVascular Center CVC, Frankfurt, Germany.

Aims: Several left atrial appendage (LAA) closure systems are available. Due to differences in device design, the results of specific occluders derived from trials cannot simply be generalised to all devices. The present analysis sought to assess two contemporary LAA closure devices in clinical practice.

Methods And Results: The work represents a non-randomised sub-analysis of the prospective, multicentre, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the AMPLATZER Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed. A total of 641 patients at 38 centres were enrolled. Of these, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs 97% in group 2; p=0.55). The Kaplan-Meier estimated one-year composite of death or stroke was 12.0% and 12.9%, respectively (p=0.79).

Conclusions: Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences with respect to procedural safety and long-term effectiveness.
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http://dx.doi.org/10.4244/EIJ-D-19-01027DOI Listing
December 2020