Publications by authors named "Stefan Stortecky"

202 Publications

Prevalence of enterococcal groin colonization in patients undergoing cardiac interventions: Challenging antimicrobial prophylaxis with cephalosporins in TAVR patients.

J Hosp Infect 2022 Aug 6. Epub 2022 Aug 6.

Department of Infectious Diseases and Infection Prevention, Kantonsspital Aarau, Aarau, Switzerland. Electronic address:

Background: Cephalosporins are recommended for prophylaxis before transcatheter aortic valve replacement (TAVR). Infective endocarditis (IE) after TAVR is caused by enterococci in up to 30%, especially early after TAVR. Enterococcal colonization in the groin has been postulated as a source of infection, not only because prophylaxis is not covering enterococci but also because most TAVR are performed by transfemoral access. There are few data analysing the groin microbiome to demonstrate the presence of enterococci.

Aim: To assess prevalence of enterococci in groins of cardiological patients receiving transfemoral interventions.

Methods: Prospective cohort study at the University Hospital Basel, Switzerland, between February and August 2020. From consecutive patients with transfemoral cardiac interventions two skin swabs from the groin were taken before antibiotic prophylaxis was administered: each one before/after groin disinfection. Swabs were analysed in the local microbiological laboratory following validated culture methods.

Findings: Of 290 included patients, 245 (84.5%) received coronary angiography, 31 (10.7%) TAVR, eight (2.8%) right heart catheterization, five (1.7%) closure of patent foramen ovale, one (0.3%) MitraClip®. In 48 patients, enterococci were detected before disinfection, in three, enterococci were still cultured after disinfection, and in one enterococci were only detected after disinfection. Enterococcal prevalence was 16.6% before and 1.4% after disinfection. Patients colonized with enterococci had a significantly higher body mass index and more often were diabetic.

Conclusion: Common enterococcal colonization of the groin coupled with frequently isolated enterococci from patients with TAVR-associated IE provide strong evidence to replace currently recommended antimicrobial prophylaxis with cephalosporins before TAVR with a compound that is active against enterococci.
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http://dx.doi.org/10.1016/j.jhin.2022.07.020DOI Listing
August 2022

Risk and Timing of Noncardiac Surgery After Transcatheter Aortic Valve Implantation.

JAMA Netw Open 2022 07 1;5(7):e2220689. Epub 2022 Jul 1.

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.

Importance: Noncardiac surgery after transcatheter aortic valve implantation (TAVI) is a clinical challenge with concerns about safety and optimal management.

Objectives: To evaluate perioperative risk of adverse events associated with noncardiac surgery after TAVI by timing of surgery, type of surgery, and TAVI valve performance.

Design, Setting, And Participants: This cohort study was conducted using data from a prospective TAVI registry of patients at the tertiary care University Hospital in Bern, Switzerland. All patients undergoing noncardiac surgery after TAVI were identified. Data were analyzed from November through December 2021.

Exposures: Timing, clinical urgency, and risk category of noncardiac surgery were assessed among patients who had undergone TAVI and subsequent noncardiac surgery.

Main Outcomes And Measures: A composite of death, stroke, myocardial infarction, and major or life-threatening bleeding within 30 days after noncardiac surgery.

Results: Among 2238 patients undergoing TAVI between 2013 and 2020, 300 patients (mean [SD] age, 81.8 [6.6] years; 144 [48.0%] women) underwent elective (160 patients) or urgent (140 patients) noncardiac surgery after TAVI and were included in the analysis. Of these individuals, 63 patients (21.0%) had noncardiac surgery within 30 days of TAVI. Procedures were categorized into low-risk (21 patients), intermediate-risk (190 patients), and high-risk (89 patients) surgery. Composite end points occurred within 30 days of surgery among 58 patients (Kaplan-Meier estimate, 19.7%; 95% CI, 15.6%-24.7%). There were no significant differences in baseline demographics between patients with the 30-day composite end point and 242 patients without this end point, including mean (SD) age (81.3 [7.1] years vs 81.9 [6.5] years; P = .28) and sex (25 [43.1%] women vs 119 [49.2%] women; P = .37). Timing (ie, ≤30 days from TAVI to noncardiac surgery), urgency, and risk category of surgery were not associated with increased risk of the end point. Moderate or severe prosthesis-patient mismatch (adjusted hazard ratio [aHR], 2.33; 95% CI, 1.37-3.95; P = .002) and moderate or severe paravalvular regurgitation (aHR, 3.61; 95% CI 1.25-10.41; P = .02) were independently associated with increased risk of the end point.

Conclusions And Relevance: These findings suggest that noncardiac surgery may be performed early after successful TAVI. Suboptimal device performance, such as prosthesis-patient mismatch and paravalvular regurgitation, was associated with increased risk of adverse outcomes after noncardiac surgery.
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http://dx.doi.org/10.1001/jamanetworkopen.2022.20689DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9264039PMC
July 2022

Enoxaparin for primary thromboprophylaxis in symptomatic outpatients with COVID-19 (OVID): a randomised, open-label, parallel-group, multicentre, phase 3 trial.

Lancet Haematol 2022 Aug 30;9(8):e585-e593. Epub 2022 Jun 30.

Department of Angiology, University Hospital Zurich, Zurich, Switzerland; University of Zurich, Zurich, Switzerland.

Background: COVID-19 is a viral prothrombotic respiratory infection. Heparins exert antithrombotic and anti-inflammatory effects, and might have antiviral properties. We aimed to investigate whether thromboprophylaxis with enoxaparin would prevent untoward hospitalisation and death in symptomatic, but clinically stable outpatients with COVID-19.

Methods: OVID was a randomised, open-label, parallel-group, investigator-initiated, phase 3 trial and was done at eight centres in Switzerland and Germany. Outpatients aged 50 years or older with acute COVID-19 were eligible if they presented with respiratory symptoms or body temperature higher than 37·5°C. Eligible participants underwent block-stratified randomisation (by age group 50-70 vs >70 years and by study centre) in a 1:1 ratio to receive either subcutaneous enoxaparin 40 mg once daily for 14 days versus standard of care (no thromboprophylaxis). The primary outcome was a composite of any untoward hospitalisation and all-cause death within 30 days of randomisation. Analysis of the efficacy outcomes was done in the intention-to-treat population. The primary safety outcome was major bleeding. The study was registered in ClinicalTrials.gov (NCT04400799) and has been completed.

Findings: At the predefined formal interim analysis for efficacy (50% of total study population), the independent Data Safety Monitoring Board recommended early termination of the trial on the basis of predefined statistical criteria having considered the very low probability of showing superiority of thromboprophylaxis with enoxaparin for the primary outcome under the initial study design assumptions. Between Aug 15, 2020, and Jan 14, 2022, from 3319 participants prescreened, 472 were included in the intention-to-treat population and randomly assigned to receive enoxaparin (n=234) or standard of care (n=238). The median age was 57 years (IQR 53-62) and 217 (46%) were women. The 30-day risk of the primary outcome was similar in participants allocated to receive enoxaparin and in controls (8 [3%] of 234 vs 8 [3%] of 238; adjusted relative risk 0·98; 95% CI 0·37-2·56; p=0·96). All hospitalisations were related to COVID-19. No deaths were reported during the study. No major bleeding events were recorded. Eight serious adverse events were recorded in the enoxaparin group versus nine in the control group.

Interpretation: These findings suggest thromboprophylaxis with enoxaparin does not reduce early hospitalisations and deaths among outpatients with symptomatic COVID-19. Futility of the treatment under the initial study design assumptions could not be conclusively assessed owing to under-representation of older patients and consequent low event rates.

Funding: SNSF (National Research Programme COVID-19 NRP78: 198352), University Hospital Zurich, University of Zurich, Dr-Ing Georg Pollert (Berlin), Johanna Dürmüller-Bol Foundation.
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http://dx.doi.org/10.1016/S2352-3026(22)00175-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9243568PMC
August 2022

Assessment of New Onset Arrhythmias After Transcatheter Aortic Valve Implantation Using an Implantable Cardiac Monitor.

Front Cardiovasc Med 2022 16;9:876546. Epub 2022 May 16.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Background: Transcatheter aortic valve implantation (TAVI) is associated with new onset brady- and tachyarrhythmias which may impact clinical outcome.

Aims: To investigate the true incidence of new onset arrhythmias within 12 months after TAVI using an implantable cardiac monitor (ICM).

Methods: One hundred patients undergoing TAVI received an ICM within 3 months before or up to 5 days after TAVI. Patients were followed-up for 12 months after discharge from TAVI for the occurrence of atrial fibrillation (AF), bradycardia (≤30 bpm), advanced atrioventricular (AV) block, sustained ventricular and supraventricular tachycardia.

Results: A previously undiagnosed arrhythmia was observed in 31 patients (31%) and comprised AF in 19 patients (19%), advanced AV block in 3 patients (3%), and sustained supraventricular and ventricular tachycardia in 10 (10%) and 2 patients (2%), respectively. Three patients had a clinical diagnosis of sick-sinus-syndrome. A permanent pacemaker (PPM) was implanted in six patients (6%). The prevalence of pre-existing AF was 28%, and 47% of the patients had AF at the end of the study period. AF burden was significantly higher in patients with pre-existing [26.7% (IQR 0.3%; 100%)] compared to patients with new-onset AF [0.0% (IQR 0.0%; 0.06%); = 0.001]. Three patients died after TAVI without evidence of an arrhythmic cause according to the available ICM recordings.

Conclusions: Rhythm monitoring for 12 months after TAVI revealed new arrhythmias, mainly AF, in almost one third of patients. Atrial fibrillation burden was higher in patients with prevalent compared to incident AF. Selected patients may benefit from short-term remote monitoring.

Trial Registration: https://clinicaltrials.gov/: NCT02559011.
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http://dx.doi.org/10.3389/fcvm.2022.876546DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9149277PMC
May 2022

Diagnostic performance of quantitative coronary artery disease assessment using computed tomography in patients with aortic stenosis undergoing transcatheter aortic-valve implantation.

BMC Cardiovasc Disord 2022 04 18;22(1):178. Epub 2022 Apr 18.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.

Background: Computed tomography angiography (CTA) is a cornerstone in the pre- transcatheter aortic valve replacement (TAVI) assessment. We evaluated the diagnostic performance of CTA and coronary artery calcium score (CACS) for CAD evaluation compared to invasive coronary angiography in a cohort of TAVI patients.

Methods: In consecutive TAVI patients without prior coronary revascularization and device implants, CAD was assessment by quantitative analysis in CTA. (a) Patients with non-evaluable segments were classified as obstructive CAD. (b) In patients with non-evaluable segments a CACS cut-off of 100 was applied for obstructive CAD. The reference standard was quantitative invasive coronary angiography (QCA, i.e. ≥ 50% stenosis).

Results: 100 consecutive patients were retrospectively included, age was 82.3 ± 6.5 years and 30% of patients had CAD. In 16% of the patients, adequate visualization of the entire coronary tree (all 16 segments) was possible with CTA, while 84% had at least one segment which was not evaluable for CAD analysis due to impaired image quality. On a per-patient analysis, where patients with low image quality were classified as CAD, CTA showed a sensitivity of 100% (95% CI 88.4-100.0), specificity of 11.4% (95% CI 5.1-21.3), PPV of 32.6% (95% CI 30.8-34.5), NPV of 100% and diagnostic accuracy of 38% (95% CI 28.5-48.3) for obstructive CAD. When applying a combined approach of CTA (in patients with good image quality) and CACS (in patients with low image quality), the sensitivity and NPV remained at 100% and obstructive CAD could be ruled out in 20% of the TAVI patients, versus 8% using CTA alone.

Conclusion: In routinely acquired pre-TAVI CTA, the image quality was insufficient in a high proportion of patients for the assessment of the entire coronary artery tree. However, when adding CACS in patients with low image quality to quantitative CTA assessment in patients with good image quality, obstructive CAD could be ruled-out in 1/5 of the patients and may therefore constitute a strategy to streamline pre-procedural workup, and reduce risk, radiation and costs in selected TAVI patients without prior coronary revascularization or device implants.
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http://dx.doi.org/10.1186/s12872-022-02623-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9014581PMC
April 2022

Mitral Valve Infective Endocarditis after Trans-Catheter Aortic Valve Implantation.

Am J Cardiol 2022 06 3;172:90-97. Epub 2022 Apr 3.

Sunnybrook Health Science Center, Toronto, Ontario, Canada.

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up.
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http://dx.doi.org/10.1016/j.amjcard.2022.02.034DOI Listing
June 2022

Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial.

JAMA 2022 05;327(18):1771-1781

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Importance: Coronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inhibitor alirocumab added to statin therapy on plaque burden and composition remains largely unknown.

Objective: To determine the effects of alirocumab on coronary atherosclerosis using serial multimodality intracoronary imaging in patients with acute myocardial infarction.

Design, Setting, And Participants: The PACMAN-AMI double-blind, placebo-controlled, randomized clinical trial (enrollment: May 9, 2017, through October 7, 2020; final follow-up: October 13, 2021) enrolled 300 patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals.

Interventions: Patients were randomized to receive biweekly subcutaneous alirocumab (150 mg; n = 148) or placebo (n = 152), initiated less than 24 hours after urgent percutaneous coronary intervention of the culprit lesion, for 52 weeks in addition to high-intensity statin therapy (rosuvastatin, 20 mg).

Main Outcomes And Measures: Intravascular ultrasonography (IVUS), near-infrared spectroscopy, and optical coherence tomography were serially performed in the 2 non-infarct-related coronary arteries at baseline and after 52 weeks. The primary efficacy end point was the change in IVUS-derived percent atheroma volume from baseline to week 52. Two powered secondary end points were changes in near-infrared spectroscopy-derived maximum lipid core burden index within 4 mm (higher values indicating greater lipid content) and optical coherence tomography-derived minimal fibrous cap thickness (smaller values indicating thin-capped, vulnerable plaques) from baseline to week 52.

Results: Among 300 randomized patients (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] low-density lipoprotein cholesterol level, 152.4 [33.8] mg/dL), 265 (88.3%) underwent serial IVUS imaging in 537 arteries. At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001). Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 μm with alirocumab vs 33.19 μm with placebo (difference, 29.65 μm [95% CI, 11.75-47.55]; P = .001). Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo.

Conclusions And Relevance: Among patients with acute myocardial infarction, the addition of subcutaneous biweekly alirocumab, compared with placebo, to high-intensity statin therapy resulted in significantly greater coronary plaque regression in non-infarct-related arteries after 52 weeks. Further research is needed to understand whether alirocumab improves clinical outcomes in this population.

Trial Registration: ClinicalTrials.gov Identifier: NCT03067844.
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http://dx.doi.org/10.1001/jama.2022.5218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8978048PMC
May 2022

Transcatheter aortic valve implantation in patients with rheumatic aortic stenosis.

Heart 2022 Jul 13;108(15):1225-1233. Epub 2022 Jul 13.

Cardiology, Inselspital, University of Bern, Bern, Switzerland

Background: Rheumatic heart disease (RHD) accounts for the highest number of deaths from valvular heart disease globally. Yet, rheumatic aortic stenosis (AS) was excluded from landmark studies investigating the safety and efficacy of transcatheter aortic valve implantation (TAVI). We aimed to describe the clinical and anatomical characteristics of patients with rheumatic AS undergoing TAVI, and to compare procedural and clinical outcomes with patients undergoing TAVI for degenerative AS.

Methods: In a prospective TAVI registry, patients with rheumatic AS were identified based on International Classification of Diseases version 10 codes and/or a documented history of acute rheumatic fever and/or the World Heart Federation criteria for echocardiographic diagnosis of RHD, and were propensity score-matched in a 1:4 ratio to patients with degenerative AS.

Results: Among 2329 patients undergoing TAVI, 105 (4.5%) had rheumatic AS. Compared with patients with degenerative AS, patients with rheumatic AS were more commonly female, older, had higher surgical risk and more commonly suffered from multivalvular heart disease. In the unmatched cohort, both technical success (85.7% vs 85.9%, p=0.887) and 1-year cardiovascular mortality (10.0% vs 8.6%; HR 1.16, 95% CI 0.61 to 2.18, p=0.656) were comparable between patients with rheumatic and degenerative AS. In contrast, patients with rheumatic AS had lower rates of 30-day and 1-year cardiovascular mortality compared with matched patients with degenerative AS (1.9% vs 8.9%, adjusted HR (HR) 0.18, 95% CI 0.04 to 0.80, p=0.024; and 10.0% vs 20.3%, HR 0.44, 95% CI 0.24 to 0.84, p=0.012, respectively).

Conclusion: TAVI may be a safe and effective treatment strategy for selected elderly patients with rheumatic AS.

Trial Registration Number: NCT01368250.
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http://dx.doi.org/10.1136/heartjnl-2021-320531DOI Listing
July 2022

Impact of first-phase ejection fraction on clinical outcomes in patients undergoing transcatheter aortic valve implantation.

Cardiovasc Revasc Med 2022 Feb 26. Epub 2022 Feb 26.

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address:

Background: First-phase left ventricular ejection fraction (LVEF1) is an early marker of left ventricular remodeling. Reduced LVEF1 has been associated with adverse prognosis in patients with aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF). It remains to be determined, whether reduced LVEF1 differentiates clinical outcomes after aortic valve replacement.

Objectives: We investigated the impact of LVEF1 on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) for symptomatic severe AS with preserved LVEF (≥ 50%).

Methods: In the prospective Bern TAVI registry, we retrospectively categorized patients according to LVEF1 as assessed by transthoracic echocardiography. Clinical outcomes of interest were all-cause mortality and residual heart failure symptoms (New York Heart Association (NYHA) functional class III or IV) at 1 year after TAVI.

Results: A total of 644 patients undergoing TAVI between January 2014 and December 2019 were included in the present analysis. Patients with low LVEF1 had a lower LVEF (62.0 ± 6.89% vs. 64.3 ± 7.82%, P < 0.001) and a higher left ventricular mass index (129.3 ± 39.1 g/m vs. 121.5 ± 38.0 g/m; P = 0.027) compared to patients with high LVEF1. At 1 year, the incidence of all-cause/cardiovascular death, and NYHA III or IV were comparable between patients with low and high LVEF1 (8.3% vs. 9.2%; P = 0.773, 3.9% vs. 6.0%; P = 0.276, 12.9% vs. 12.2%; P = 0.892, respectively).

Conclusions: Reduced LVEF1 was not associated with adverse clinical outcomes following TAVI in patients with symptomatic severe AS with preserved LVEF.

Clinical Trial Registration: https://www.

Clinicaltrials: gov. NCT01368250.
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http://dx.doi.org/10.1016/j.carrev.2022.02.023DOI Listing
February 2022

Surgical Treatment of Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.

J Am Coll Cardiol 2022 03;79(8):772-785

Sunnybrook Health Science Center, Toronto, Ontario, Canada.

Background: The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain.

Objectives: The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB).

Methods: Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry.

Results: Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HR: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HR: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HR: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HR: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock.

Conclusions: In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications.
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http://dx.doi.org/10.1016/j.jacc.2021.11.056DOI Listing
March 2022

Self-reported non-adherence to P2Y12 inhibitors in patients undergoing percutaneous coronary intervention: Application of the medication non-adherence academic research consortium classification.

PLoS One 2022 16;17(2):e0263180. Epub 2022 Feb 16.

Department of Cardiology, Bern University Hospital, Bern, Switzerland.

Aims: The Non-adherence Academic Research Consortium (NARC) has recently developed a consensus-based standardized classification for medication non-adherence in cardiovascular clinical trials. We aimed to assess the prevalence of NARC-defined self-reported non-adherence to P2Y12 inhibitors and its impact on clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).

Methods And Results: Using a standardized questionnaire administered at 1 year after PCI, we assessed the 4 NARC-defined non-adherence levels including type, decision-maker, reasons, and timing within the Bern PCI registry. The primary endpoint was the patient-oriented composite endpoint (POCE) defined as a composite of death, myocardial infarction, stroke, and any revascularization at 1 year. The recommended P2Y12 inhibitor duration was 12 months. Among 3,896 patients, P2Y12 inhibitor non-adherence was observed in 647 (17%) patients. Discontinuation was permanent in the majority of patients (84%). The decision was mainly driven by a physician (94%), and rarely by patients (6%). The most frequent reason was risk profile change (43%), followed by unlisted reasons (25%), surgery (17%), and adverse events (14%). Non-adherence occurred early (<30 days) in 21%, late (30-180 days) in 45%, and very late (>180 days) in 33%. The majority of POCE events (n = 421/502, 84%) occurred during adherence to the prescribed P2Y12 inhibitor. Permanent discontinuation, doctor-driven non-adherence, and risk profile change emerged as independent predictors for POCE.

Conclusions: In real-world PCI population treated with 1-year DAPT, non-adherence was observed in nearly one-fifth of patients. Non-adherence to P2Y12 inhibitors was associated with worse clinical outcomes, while the risk was related to underlying contexts.

Clinicaltrials.gov Identifier: NCT02241291.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0263180PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8849552PMC
February 2022

Cardiovascular outcomes in patients with left atrial enlargement undergoing transcatheter aortic valve implantation.

Catheter Cardiovasc Interv 2022 05 16;99(6):1908-1917. Epub 2022 Feb 16.

Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.

Background: Increased left ventricular afterload resulting from severe aortic stenosis (AS) leads to progressive cardiac remodeling. Left atrial enlargement (LAE) is an early manifestation in a series of maladaptive changes and may affect clinical outcomes after valvular replacement therapy. The aim of this study is to determine the impact of LAE on clinical outcomes in symptomatic patients with severe AS undergoing transcatheter aortic valve implantation (TAVI).

Methods: In a prospective single-center TAVI registry, we analyzed LA dimensions measured by echocardiography before intervention. Patients with atrial fibrillation or concomitant mitral valve disease were excluded. LAE was defined as indexed LA volume >34 ml/m . The primary endpoint was cardiovascular death (CVD) at 1 year.

Results: Among 1663 patients undergoing TAVI between August 2007 and December 2016, 768 (46.2%) were eligible for the present analysis and 486 patients had LAE. The prevalence of LAE was higher in males (68.3%) as compared to females (58.8%). Patients with LAE were older (82.3 ± 6.7 years vs. 80.0 ± 6.4 years) and had a higher STS-PROM score (6.1 ± 4.7% vs. 4.7 ± 2.9%). After adjustment, patients with LAE had an increased risk of CVD at 1-year compared to patients with normal LA dimensions (49 [10.4%] vs. 8 [2.9%]; HR , 3.52; 95% CI, 1.66-7.44)]. In multivariable analysis, LAE was independently associated with an increased risk of CVD at 1-year (HR , 3.52; 95% CI, 1.66-7.44).

Conclusions: LAE secondary to AS was documented in a significant proportion of patients undergoing TAVI and was associated with a more than threefold increased risk of CVD at 1-year.
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http://dx.doi.org/10.1002/ccd.30132DOI Listing
May 2022

Reproducibility of 4D cardiac computed tomography feature tracking myocardial strain and comparison against speckle-tracking echocardiography in patients with severe aortic stenosis.

J Cardiovasc Comput Tomogr 2022 Jul-Aug;16(4):309-318. Epub 2022 Jan 31.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address:

Background: Myocardial strain is an established parameter for the assessment of cardiac function and routinely derived from speckle tracking echocardiography (STE). Novel post-processing tools allow deformation imaging also by 4D cardiac computed tomography angiography (CCT). This retrospective study aims to analyze the reproducibility of CCT strain and compare it to that of STE.

Methods: Left (LV) and right ventricular (RV), and left atrial (LA) ejection fraction (EF), dimensions, global longitudinal (GLS), circumferential (GCS) and radial strain (GRS) were determined by STE and CCT feature tracking in consecutive patients with severe aortic stenosis evaluated for transcatheter aortic valve implantation.

Results: 106 patients (mean age 79.9 ​± ​7.8, 44.3% females) underwent CCT at a median of 3 days (IQR 0-28 days) after STE. In CCT, strain measures showed good to excellent reproducibility (intra- and inter-reader intraclass correlation coefficient ≥0.75) consistently in the LV, RV and LA. In STE, only LV GLS and LA GLS yielded good reproducibility, whereas LV GCS and LV GRS showed moderate, and RV GLS and free wall longitudinal strain (FWLS) poor reproducibility. Agreement between CCT and STE was strong for LV GLS only, while other strain features displayed moderate (LV GCS, LA GLS) or weak (LV GRS, RV GLS and FWLS) inter-modality correlation.

Conclusion: LV, RV and LA CCT strain assessments were highly reproducible. While a strong agreement to STE was found for LV GLS, inter-modality correlation was moderate or weak for LV GCS, LV GRS, and RV and LA longitudinal strain, possibly related to poor reproducibility of STE measurements.
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http://dx.doi.org/10.1016/j.jcct.2022.01.003DOI Listing
July 2022

Frequency and Outcomes of Periprocedural MI in Patients With Chronic Coronary Syndromes Undergoing PCI.

J Am Coll Cardiol 2022 02;79(6):513-526

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address:

Background: Definitions of periprocedural myocardial infarction (MI) differ with respect to biomarker threshold as well as ancillary criteria for myocardial ischemia and are limited in terms of validation.

Objectives: This study evaluated the frequency and impact of periprocedural MI by using various MI definitions among patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI).

Methods: Between 2010 and 2018, periprocedural MIs were assessed according to the third and fourth Universal Definition of Myocardial Infarction (UDMI), Academic Research Consortium-2 (ARC-2), and Society for Cardiovascular Angiography and Interventions (SCAI) criteria based on high-sensitivity troponin in patients with CCS undergoing PCI enrolled into the Bern PCI registry. The primary endpoint was cardiac death at 1 year.

Results: Among 4,404 patients with CCS, periprocedural MI defined by the third UDMI, fourth UDMI, ARC-2, and SCAI were observed in 18.0%, 14.9%, 2.0%, and 2.0% of patients, respectively. Among patients with periprocedural MI defined by the third UDMI, fourth UDMI, ARC-2, and SCAI, cardiac mortality at 1 year was 2.9%, 3.0%, 5.8%, and 10.0%. The ARC-2 (HR: 3.90; 95% CI: 1.54-9.93) and SCAI (HR: 7.66; 95% CI: 3.64-16.11) were more relevant compared with the third UDMI (HR: 1.76; 95% CI: 1.04-3.00) and fourth UDMI (HR: 1.93; 95% CI: 1.11-3.37) for cardiac death at 1 year.

Conclusions: Among patients with CCS undergoing PCI, periprocedural MI defined according to the ARC-2 and SCAI criteria was 7 to 9 times less frequent compared with the third and fourth UDMI. Periprocedural MI defined by using the ARC-2 and SCAI were more prognostic for cardiac death at 1 year compared with the third and fourth UDMI. (CARDIOBASE Bern PCI Registry; NCT02241291).
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http://dx.doi.org/10.1016/j.jacc.2021.11.047DOI Listing
February 2022

Validation of the VARC-3 Technical Success Definition in Patients Undergoing TAVR.

JACC Cardiovasc Interv 2022 02 31;15(4):353-364. Epub 2022 Jan 31.

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address:

Objectives: The authors aimed to investigate the rates, predictors, and prognostic impact of technical success in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: The Valve Academic Research Consortium-3 (VARC-3) has introduced a composite endpoint to assess the immediate technical success of TAVR.

Methods: In the prospective Bern TAVR registry, patients were stratified according to VARC-3 technical success. Technical failure differentiated between vascular and cardiac complications.

Results: In a total of 1,624 patients undergoing TAVR between March 2012 and December 2019, 1,435 (88.4%) patients had technical success. Among 189 patients with technical failure, 140 (8.6%) had vascular and 49 (3.0%) had cardiac technical failure. Female, larger device landing zone calcium volume, and the early term of the study period were associated with an increased risk for cardiac technical failure, whereas higher body mass index and the use of the Prostar (Abbott Vascular Inc) MANTA (Teleflex) (compared with the ProGlide [Abbott Vascular Inc]) were predictors of vascular technical failure. In multivariable analysis, technical failure conferred an increased risk for cardiovascular death or stroke (HR: 2.01; 95% CI: 1.37-2.95). The adverse effect remained when stratified to cardiac (HR: 2.62; 95% CI: 1.38-4.97) or vascular technical failure (HR: 1.95; 95% CI: 1.28-2.95) and limited to the periprocedural period (0-30 days: HR: 3.42 [95% CI: 2.05-5.69]; 30-360 days: HR: 1.36 [95% CI: 0.79-2.35]; P for interaction = 0.002).

Conclusions: Technical failure according to VARC-3 was observed in 1 of 10 patients undergoing TAVR and was associated with a 2-fold increased risk of the composite outcome at 1 year after TAVR. (Swiss TAVI Registry; NCT01368250).
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http://dx.doi.org/10.1016/j.jcin.2021.11.013DOI Listing
February 2022

Acute coronary syndromes in young patients: Phenotypes, causes and clinical outcomes following percutaneous coronary interventions.

Int J Cardiol 2022 03 13;350:1-8. Epub 2022 Jan 13.

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Background: The prevalence of acute coronary syndromes (ACS) among young individuals is increasing, but the phenotypic characteristics, causes and clinical outcomes in this group have not been well described.

Methods: Between 2009 and 2017, 8712 ACS patients underwent percutaneous coronary intervention (PCI) and were prospectively enrolled. We defined a young patient as female <50 years and male <45 years. The causes of ACS were defined by an adjudication committee. The primary endpoint was the patient-oriented composite endpoint (POCE) of all-cause mortality, myocardial infarction or any revascularization at 12 months.

Results: Among 8712 ACS patients, 472 (5.4%) patients were young (26% female). The main cause of ACS in young patients was atherosclerosis (86.5%), followed by coronary artery embolism (9%), and spontaneous coronary artery dissection (SCAD) (4.5%). POCE occurred less frequently in young compared to old patients (8.5% vs. 16.7%, hazard ratio 0.48 (95% confidence interval 0.35-0.66), p < 0.001). The rates of the individual components of the POCE were lower in young including all-cause mortality (3.2% versus 9.5%, 0.32 (0.19-0.54), p < 0.001), myocardial infarction (1.9% versus 3.7%, 0.49 (0.25-0.95), p = 0.035) and any revascularization (5.1% versus 7.4%, 0.65 (0.43-0.97), p = 0.037). Young patients with SCAD had a higher rate of death as compared to those with atherosclerosis, mainly attributed to cardiac deaths.

Conclusions: One out of 20 ACS patients undergoing PCI was young and the principal cause was atherosclerosis. Young carry a lower risk for future events compared to older ACS patients. The underlying cause leading to ACS should be considered in appropriate risk stratification of young patients.

Clinical Trial Registration: Clinicaltrials.gov. NCT02241291.
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http://dx.doi.org/10.1016/j.ijcard.2022.01.018DOI Listing
March 2022

Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.

EuroIntervention 2022 May;18(1):33-42

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.

Background: Mild paravalvular regurgitation (PVR) remains a frequent and underappreciated adverse event after transcatheter aortic valve implantation (TAVI) despite remarkable progress in device technology and implantation technique.

Aims: This study sought to investigate the impact of mild PVR after TAVI on five-year clinical outcomes.

Methods: In a prospective TAVI registry, PVR prior to discharge was retrospectively assessed in an echocardiographic core laboratory. Patients with ≥moderate PVR were excluded. Mild PVR was categorised into mild and mild-to-moderate PVR using a recently proposed unifying 5-class grading scheme.

Results: A total of 1,128 patients undergoing TAVI between 2007 and 2015 were enrolled. Of these, 560 patients had mild PVR, including 433 with mild (5-class) PVR and 127 with mild-to-moderate PVR. Patients with mild PVR were older (83 years vs 82 years, p=0.013) and had a higher surgical risk compared to patients with none/trace PVR (STS-PROM: 6.49±4.68 vs 5.41±3.48, p<0.001). At five years, patients with mild PVR had a higher risk of mortality than those with none/trace PVR (54.6% vs 43.8%; HR 1.26, 95% CI: 1.06-1.50). When applying the 5-class grading scheme, only mild-to-moderate PVR was associated with an increased risk of mortality at five years (mild PVR: HR 1.19, 95% CI: 0.99-1.43, mild-to-moderate PVR: HR 1.56, 95% CI: 1.20-2.02). The effect of mild PVR on five-year mortality was consistent across major subgroups.

Conclusions: Mild PVR was associated with an increased risk of mortality at five years after TAVI. The detrimental effect was primarily driven by mild-to-moderate PVR using the 5-class grading scheme.

Clinical Trial Registration: https://www.

Clinicaltrials: gov. NCT01368250.
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http://dx.doi.org/10.4244/EIJ-D-21-00784DOI Listing
May 2022

Perivalvular Extension of Infective Endocarditis after Transcatheter Aortic Valve Replacement.

Clin Infect Dis 2021 Dec 11. Epub 2021 Dec 11.

Sunnybrook Health Science Center, Toronto, Canada.

Background: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients.

Methods: This multicenter study included a total of 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm or fistula confirmed by transthoracic/transophageal echocardiography, computed tomography or peri-operative findings.

Results: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (ORadj: 2.08; 95% CI: [1.27-3.41], p=0.003) and IE secondary to coagulase-negative staphylococci (ORadj: 2.71; 95% CI: [1.57-4.69], p<0.001) was associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs. 15.2% in patients without PEE, p<0.001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality risk were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj<0.05 for all).

Conclusion: PEE occurred in about one fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited very high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.
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http://dx.doi.org/10.1093/cid/ciab1004DOI Listing
December 2021

Effect of Timing of Staged Percutaneous Coronary Intervention on Clinical Outcomes in Patients With Acute Coronary Syndromes.

J Am Heart Assoc 2021 12 24;10(23):e023129. Epub 2021 Nov 24.

Department of Cardiology Bern University HospitalUniversity of Bern Bern Switzerland.

Background Complete revascularization reduces cardiovascular events in patients with acute coronary syndromes (ACSs) and multivessel disease. The optimal time point of non-target-vessel percutaneous coronary intervention (PCI) remains a matter of debate. The aim of this study was to investigate the impact of early (<4 weeks) versus late (≥4 weeks) staged PCI of non-target-vessels in patients with ACS scheduled for staged PCI after hospital discharge. Methods and Results All patients with ACS undergoing planned staged PCI from 2009 to 2017 at Bern University Hospital, Switzerland, were analyzed. Patients with cardiogenic shock, in-hospital staged PCI, staged cardiac surgery, and multiple staged PCIs were excluded. The primary end point was all-cause death, recurrent myocardial infarction and urgent premature non-target-vessel PCI. Of 8657 patients with ACS, staged revascularization was planned in 1764 patients, of whom 1432 patients fulfilled the eligibility criteria. At 1 year, there were no significant differences in the crude or adjusted rates of the primary end point (7.8% early versus 10.8% late, hazard ratio [HR], 0.72 [95% CI, 0.47-1.10], =0.129; adjusted HR, 0.80 [95% CI, 0.50-1.28], =0.346) and its individual components (all-cause death: 1.5% versus 2.9%, HR, 0.52 [95% CI, 0.20-1.33], =0.170; adjusted HR, 0.62 [95% CI, 0.23-1.67], =0.343; recurrent myocardial infarction: 4.2% versus 4.4%, HR, 0.97 [95% CI, 0.475-1.10], =0.924; adjusted HR, 1.03 [95% CI, 0.53-2.01], =0.935; non-target-vessel PCI, 3.9% versus 5.7%, HR, 0.97 [95% CI, 0.53-1.80], =0.928; adjusted HR, 1.19 [95% CI, 0.61-2.34], =0.609). Conclusions In this single-center cohort study of patients with ACS scheduled to undergo staged PCI after hospital discharge, early (<4 weeks) versus late (≥4 weeks) staged PCI was associated with a similar rate of major adverse cardiac events at 1 year follow-up. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.
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http://dx.doi.org/10.1161/JAHA.121.023129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9075355PMC
December 2021

A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).

EuroIntervention 2022 Jun 3;18(2):e132-e139. Epub 2022 Jun 3.

University Hospital Zurich, Zurich, Switzerland.

Background: Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy.

Aims: The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate.

Methods: BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up.

Results: Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration.

Conclusions: The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.
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http://dx.doi.org/10.4244/EIJ-D-21-00537DOI Listing
June 2022

Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

Am Heart J 2022 02 14;244:94-106. Epub 2021 Nov 14.

Department of Cardiac Surgery, Inselspital, University of Bern, Bern, Switzerland.

Background: Ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT). However, its clinical significance has not been adequately studied. We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI).

Methods: In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter indexed to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year.

Results: Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83 ± 6 vs 82 ± 6 vs 81 ± 6; P < .001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3 ± 3.8 vs 5.1 ± 3.1 vs 4.9 ± 3.5; P < .001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs 4.5% vs 3.5%; P < .001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.62; 95% CI: 1.19-2.21; P = .002) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.02-1.65; P = .035).

Conclusions: Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in patients undergoing TAVI.
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http://dx.doi.org/10.1016/j.ahj.2021.11.004DOI Listing
February 2022

Clinical outcomes following transcatheter aortic valve implantation in patients with porcelain aorta.

J Cardiovasc Comput Tomogr 2022 May-Jun;16(3):215-221. Epub 2021 Oct 28.

Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland. Electronic address:

Background: Current guidelines favor transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement in patients with porcelain aorta (PAo). The clinical relevance of PAo in patients undergoing TAVI is however incompletely understood. The purpose of this study is to evaluate clinical outcome of patients with PAo undergoing TAVI.

Methods: Consecutive patients undergoing TAVI were enrolled in a prospective single-center registry. Presence of PAo was evaluated by ECG-gated multi-slice computed tomography prior to the intervention. The primary endpoint was disabling stroke.

Results: Among 2199 patients (mean age, 82.0 ​± ​6.3 years; 1135 females [51.6%]) undergoing TAVI between August 2007 and December 2019, 114 patients (5.2%) met VARC-2 criteria for PAo. Compared to individuals without PAo, patients with PAo were younger (79.4 ​± ​7.4 years vs. 82.1 ​± ​6.2 years; p ​< ​0.001), had a lower left ventricular ejection fraction (51.8 ​± ​14.9% vs. 55.3 ​± ​14.2%; p ​= ​0.009) and higher STS-PROM Scores (6.5 ​± ​4.3% vs. 4.9 ​± ​3.4%; p ​< ​0.001). At 1 year, disabling stroke occurred more often in patients with PAo (7.2%) than in those without (3.0%) (HR, 2.49; 95% CI, 1.12-5.55). The risk difference emerged within 30 days after TAVI (HR, 3.70; 95% CI, 1.52-9.03), and was driven by a high PAo-associated risk of disabling stroke in patients with alternative access (HR, 5.79; 95% CI, 1.38-24.3), not in those with transfemoral (HR, 1.47; 95% CI 0.45-4.85).

Conclusions: TAVI patients with PAo had a more than three-fold increased risk of periprocedural disabling stroke compared to patients with no PAo. The difference was driven by a higher risk of stroke in patients treated by alternative access.
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http://dx.doi.org/10.1016/j.jcct.2021.10.006DOI Listing
April 2022

Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement.

Can J Cardiol 2022 01 21;38(1):102-112. Epub 2021 Oct 21.

Emory University School of Medicine, Atlanta, Georgia, USA.

Background: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR).

Methods: Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE.

Results: SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038).

Conclusions: SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.
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http://dx.doi.org/10.1016/j.cjca.2021.10.004DOI Listing
January 2022

Potential Candidates for Transcatheter Tricuspid Valve Intervention After Transcatheter Aortic Valve Replacement: Predictors and Prognosis.

JACC Cardiovasc Interv 2021 10 29;14(20):2246-2256. Epub 2021 Sep 29.

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address:

Objectives: The aims of this study were to document the prevalence of concomitant tricuspid regurgitation (TR) before and after transcatheter aortic valve replacement (TAVR), to quantify potential eligibility for transcatheter tricuspid valve intervention (TTVI), and to report clinical outcomes as a function of the severity of TR and potential candidacy for TTVI.

Background: The importance of concomitant TR in patients with severe aortic stenosis undergoing TAVR remains unclear.

Methods: In a prospective TAVR registry, the severity of TR before and after TAVR was retrospectively evaluated in an echocardiography core laboratory.

Results: Among 2,008 eligible patients, 1,659 patients (82.6%) had mild or less TR, 242 (12.1%) had moderate TR, 57 (2.8%) had severe TR, and 50 (2.5%) had massive TR. More than one-half of patients with moderate or greater TR had a reduction in TR, while a small proportion of patients with severe or less of TR had worsening of TR after TAVR. In contrast to TR at baseline, severe TR (adjusted HR [HR]: 1.90; 95% CI: 1.03-3.49) and massive TR (HR: 2.17; 95% CI: 1.10-4.30) after TAVR conferred an increased risk for mortality compared with mild or less TR at 1 year after TAVR. After TAVR, 63 patients (3.1%) were deemed potential candidates for TTVI. They had a 2-fold increased risk for mortality between 30 days and 1 year (HR: 1.93; 95% CI: 1.15-3.25) and a higher risk for persistent heart failure symptoms (adjusted risk ratio: 2.80; 95% CI: 1.78-4.40).

Conclusions: A non-negligible proportion of patients were considered potential candidates for TTVI after TAVR and had impaired prognosis and persistently impaired functional status at 1 year. (SwissTAVI Registry; NCT01368250).
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http://dx.doi.org/10.1016/j.jcin.2021.07.030DOI Listing
October 2021

Interventional Reperfusion Strategies for Acute Pulmonary Embolism.

Praxis (Bern 1994) 2021 Sep;110(13):743-751

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern.

Acute pulmonary embolism (APE) is a common, potentially life-threatening cardiovascular emergency, and represents the third leading cause of cardiovascular mortality after myocardial infarction and stroke. Risk stratification is important to guide the management of APE, as an early reperfusion strategy is associated with improved clinical outcomes in specific high-risk conditions. Pulmonary artery reperfusion is commonly achieved by systemic intravenous administration of thrombolytic drugs, but catheter-directed thrombolysis (CDThr) and interventional techniques of catheter-based embolectomy provide novel therapeutic approaches with an improved risk-benefit ratio. Future trials will help to determine when to use these different devices in massive or sub-massive APE, and which patient population is likely to benefit from interventional treatment.
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http://dx.doi.org/10.1024/1661-8157/a003737DOI Listing
September 2021

Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement.

J Am Heart Assoc 2021 10 28;10(19):e020368. Epub 2021 Sep 28.

Department of Cardiology InselspitalBern University Hospital Bern Switzerland.

Background Data comparing the frequency and outcomes of infective endocarditis (IE) after transcatheter (TAVR) to surgical aortic valve replacement (SAVR) are scarce. The objective of this study is to compare the incidence and outcomes of IE after TAVR using a supra-annular, self-expanding platform (CoreValve and Evolut) to SAVR. Methods and Results Data of 3 randomized clinical trials comparing TAVR to SAVR and a prospective continued TAVR access study were pooled. IE was defined on the basis of the modified Duke criteria. The cumulative incidence of IE was determined by modeling the cause-specific hazard. Estimates of all-cause mortality were calculated by means of the Kaplan-Meier method. Outcomes are reported for the valve-implant cohort. During a mean follow-up time of 2.17±1.51 years, 12 (0.5%) of 2249 patients undergoing TAVR and 21 (1.1%) of 1828 patients undergoing SAVR developed IE. Patients with IE more frequently had diabetes mellitus than those without (57.6% versus 34.2%; =0.005). The cumulative incidence of IE was 1.01% (95% CI, 0.47%-1.96%) after TAVR and 1.58% (95% CI, 0.97%-2.46%) after SAVR (=0.047) at 5 years. Among patients with IE, the rate of all-cause mortality was 27.3% (95% CI, 1.0%-53.6%) in the TAVR and 51.8% (95% CI, 28.2%-75.3%) in the SAVR group at 1 year (log-rank =0.15). Conclusions Pooled prospectively collected data comparing TAVR with a supra-annular, self-expanding device to SAVR showed a low cumulative risk of IE irrespective of treatment modality, although the risk was lower in the TAVR implant group. Once IE occurred, mortality was high. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01240902, NCT01586910, NCT02701283.
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http://dx.doi.org/10.1161/JAHA.120.020368DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8649131PMC
October 2021

Deep learning-based prediction of early cerebrovascular events after transcatheter aortic valve replacement.

Sci Rep 2021 09 21;11(1):18754. Epub 2021 Sep 21.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Cerebrovascular events (CVE) are among the most feared complications of transcatheter aortic valve replacement (TAVR). CVE appear difficult to predict due to their multifactorial origin incompletely explained by clinical predictors. We aimed to build a deep learning-based predictive tool for TAVR-related CVE. Integrated clinical and imaging characteristics from consecutive patients enrolled into a prospective TAVR registry were analysed. CVE comprised any strokes and transient ischemic attacks. Predictive variables were selected by recursive feature reduction to train an autoencoder predictive model. Area under the curve (AUC) represented the model's performance to predict 30-day CVE. Among 2279 patients included between 2007 and 2019, both clinical and imaging data were available in 1492 patients. Median age was 83 years and STS score was 4.6%. Acute (< 24 h) and subacute (day 2-30) CVE occurred in 19 (1.3%) and 36 (2.4%) patients, respectively. The occurrence of CVE was associated with an increased risk of death (HR [95% CI] 2.62 [1.82-3.78]). The constructed predictive model uses less than 107 clinical and imaging variables and has an AUC of 0.79 (0.65-0.93). TAVR-related CVE can be predicted using a deep learning-based predictive algorithm. The model is implemented online for broad usage.
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http://dx.doi.org/10.1038/s41598-021-98265-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8455675PMC
September 2021

Clinical impact of left atrial appendage filling defects in patients undergoing transcatheter aortic valve implantation.

Eur Heart J Cardiovasc Imaging 2021 Aug 31. Epub 2021 Aug 31.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010 Bern, Switzerland.

Aims: Incidental detection of left atrial appendage (LAA) filling defects is a common finding on multi-detector computed tomography in aortic stenosis patients under evaluation for transcatheter aortic valve implantation (TAVI). We aimed to investigate the incidence of LAA filling defects before TAVI and its impact on clinical outcomes.

Methods And Results: In a prospective registry, LAA filling defects were retrospectively evaluated and categorized into one of four sub-types: thrombus-like, heterogeneous, horizontal, and Hounsfield Unit (HU)-run-off. The primary endpoint was the composite of cardiovascular death or disabling stroke up to 1-year follow-up. Among 1621 patients undergoing TAVI between August 2007 and June 2018, LAA filling defects were present in 177 patients (11%), and categorized as thrombus-like in 22 (1.4%), heterogeneous in 37 (2.3%), horizontal in 80 (4.9%), and HU-run-off in 38 (2.4%). Compared to patients with normal LAA filling, patients with LAA filling defects had greater prevalence of atrial fibrillation (84.7% vs. 26.4%, P < 0.001) and history of cerebrovascular events (16.4% vs. 10.9%, P = 0.045). The primary endpoint occurred in 131 patients (9.2%) with normal LAA filling and in 36 patients (21.2%) with LAA filling defects (P < 0.001). Subgroup analysis suggested that the risk of disabling stroke was greatest in the thrombus-like pattern (23.0%), followed by the HU-run-off (8.0%), the heterogeneous (6.2%), and the horizontal pattern (1.2%).

Conclusion: LAA filling defects were observed in 11% of aortic stenosis patients undergoing TAVI and associated with an increased risk of cardiovascular death and disabling stroke up to 1 year following TAVI.

Trial Registration: https://www.clinicaltrials.gov. NCT01368250.
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http://dx.doi.org/10.1093/ehjci/jeab142DOI Listing
August 2021
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