Publications by authors named "Thomas Pilgrim"

273 Publications

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

Int J Cardiol 2022 Jan 13. Epub 2022 Jan 13.

Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, 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
January 2022

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

EuroIntervention 2021 Dec 22. Epub 2021 Dec 22.

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
December 2021

Valve-in-Valve Transcatheter Aortic Valve Replacement for the Treatment of Paravalvular Leak Due to Ring Dehiscence.

JACC Cardiovasc Interv 2021 Dec 24;14(24):2746-2748. Epub 2021 Nov 24.

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

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http://dx.doi.org/10.1016/j.jcin.2021.09.015DOI 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
December 2021

Differential Effects of Newer-Generation Ultrathin-Strut Versus Thicker-Strut Drug-Eluting Stents in Chronic and Acute Coronary Syndromes.

JACC Cardiovasc Interv 2021 Nov;14(22):2461-2473

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

Objectives: The authors sought to compare the differential effects of ultrathin-strut and thicker-strut drug-eluting stents (DES) in patients with chronic (CCS) versus acute (ACS) coronary syndromes.

Background: Newest-generation ultrathin-strut DES reduce target lesion failure (TLF) compared with thicker-strut second-generation DES in patients undergoing percutaneous coronary intervention.

Methods: PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized controlled trials comparing newer-generation ultrathin-strut (<70 μm) versus thicker-strut (≥70 μm) DES. Patients were divided based on baseline clinical presentation (CCS versus ACS). The primary endpoint was TLF, a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization (TLR).

Results: A total of 22,766 patients from 16 randomized controlled trials were included, of which 9 trials reported TLF rates in ACS patients. At a mean follow-up of 12.2 months, the risk of TLF was lower among patients treated with ultrathin-strut compared with thicker-strut DES (risk ratio [RR]: 0.85; 95% CI: 0.75-0.95; P = 0.006). The difference was driven by a lower risk of clinically-indicated TLR (RR: 0.75; 95% CI: 0.63-0.89; P < 0.001) among patients treated with ultrathin-strut DES. The treatment effect was consistent between patients presenting with CCS and ACS (relative RR: 0.97; 95% CI: 0.73-1.31; P for interaction = 0.854). In patients with ST-segment elevation myocardial infarction, TLF risk was lower among those treated with ultrathin- compared with thicker-strut DES (RR: 0.74; 95% CI: 0.54-0.99; P = 0.049).

Conclusions: Ultrathin-strut DES reduce the risk of TLF compared with thicker-strut second-generation DES in patients undergoing percutaneous coronary intervention, a difference caused by a lower risk of ischemia-driven TLR. The treatment effect was consistent among patients with CCS and ACS.
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http://dx.doi.org/10.1016/j.jcin.2021.09.028DOI Listing
November 2021

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

Am Heart J 2022 Feb 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 2021 Oct 28. 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
October 2021

Prevalence of latent structural heart disease in Nepali schoolchildren.

Cardiol Young 2021 Nov 4:1-3. Epub 2021 Nov 4.

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

Background: The present study aimed to quantify the burden of structural heart disease in Nepali children.

Methods: We performed a school-based cross-sectional echocardiographic screening study with cluster random sampling among children 5-16 years of age.

Results: Between December 2012 and January 2019, 6573 children (mean age 10.6 ± 2.9 years) from 41 randomly selected schools underwent echocardiographic screening. Structural heart disease was detected in 14.0 per 1000 children (95% CI 11.3-17.1) and was congenital in 3.3 per 1000 (95% CI 2.1-5.1) and rheumatic in 10.6 per 1000 (95% CI 8.3-13.4). Rates of rheumatic heart disease were higher among children attending public as compared to private schools (OR 2.8, 95% CI 1.6-5.2, p = 0.0001).

Conclusion: Rheumatic heart disease accounted for three out of four cases of structural heart disease and was more common among children attending public as compared to private schools.
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http://dx.doi.org/10.1017/S1047951121004479DOI Listing
November 2021

Transcatheter paravalvular leak closure: catch me if you can.

EuroIntervention 2021 Oct;17(9):699-700

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

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http://dx.doi.org/10.4244/EIJV17I9A121DOI Listing
October 2021

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

Comparison of Transvalvular Aortic Mean Gradients Obtained by Intraprocedural Echocardiography and Invasive Measurement in Balloon and Self-Expanding Transcatheter Valves.

J Am Heart Assoc 2021 10 29;10(19):e021014. Epub 2021 Sep 29.

The Heart Hospital Baylor Plano Plano TX.

Background Concerns about discordance between echocardiographic and invasive mean gradients after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEVs) versus self-expanding valves (SEVs) exist. Methods and Results In a multicenter study, direct-invasive and echocardiography-derived transvalvular mean gradients obtained before and after TAVR were compared as well as post-TAVR and discharge echocardiographic mean gradients in BEVs versus SEVs in 808 patients. Pre-TAVR, there was good correlation (=0.614; <0.0001) between direct-invasive and echocardiography-derived mean gradients and weak correlation (=0.138; <0.0001) post-TAVR. Compared with post-TAVR echocardiographic mean gradients, both valves exhibit lower invasive and higher discharge echocardiographic mean gradients. Despite similar invasive mean gradients, a small BEV exhibits higher post-TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post-TAVR and discharge mean gradients. An ejection fraction <50% (=0.028) and higher Society of Thoracic Surgeons predicted risk of mortality score (=0.007), but not invasive or echocardiographic mean gradient ≥10 mm Hg (=0.378 and =0.341, respectively), nor discharge echocardiographic mean gradient ≥20 mm Hg (=0.393), were associated with increased 2-year mortality. Conclusions Invasively measured and echocardiography-derived transvalvular mean gradients correlate well in aortic stenosis but weakly post-TAVR. Post-TAVR, echocardiography overestimates transvalvular mean gradients compared with invasive measurements, and poor correlation suggests these modalities cannot be used interchangeably. Moreover, echocardiographic mean gradients are higher on discharge than post-TAVR in all valves. Despite similar invasive mean gradients, a small BEV exhibits higher post-TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post-TAVR and discharge mean gradients. Immediately post-TAVR, elevated echocardiographic-derived mean gradients should be assessed with caution and compared with direct-invasive mean gradients. A low ejection fraction and higher Society of Thoracic Surgeons score, but not elevated mean gradients, are associated with increased 2-year mortality.
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http://dx.doi.org/10.1161/JAHA.120.021014DOI Listing
October 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
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

Anatomical and Technical Predictors of Three-Dimensional Mitral Valve Area Reduction After Transcatheter Edge-To-Edge Repair.

J Am Soc Echocardiogr 2022 Jan 11;35(1):96-104. Epub 2021 Oct 11.

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

Background: Among current transcatheter therapies for the treatment of mitral regurgitation, the MitraClip (MC; Abbott Vascular, Abbott Park, IL) system is the most commonly used. MitraClip implantation is usually contraindicated in patients with a mitral valve area (MVA) < 4.0 cm. However, little is known about the real impact of MC implantation on MVA. Our goal was to investigate the factors influencing MVA reduction and derive the minimal MVA required to prevent the development of a clinically significant mitral stenosis (MVA < 1.5 cm) in different clinical scenarios.

Methods: Using three-dimensional data sets, the annulus and leaflet anatomy and MVA before clip implantation (MVA) were assessed. After each MC implant (NTR or XTR), the relative MVA reduction and the absolute residual MVA were measured and their predictors evaluated.

Results: The present analysis included 116 patients. An MC XTR was the first device implanted in 50% of the subjects, and 53% were treated with a single implant. The MVA reduction following one XTR was 57% ± 7% versus 52% ± 8% after one NTR (P = .001). A lower MVA reduction was observed when the MC was placed commissural/central versus paracentral (50% ± 8% vs 57% ± 7%, P < .0001). After a second device, the additional MVA reduction was higher when creating a triple-compared with a double-orifice morphology (34% ± 11% vs 25% ± 9%, P = .001). The MVA after one MC correlated with MVA as well as with the clip type and position (r = 0.91, P < .0001). The MVA, orifice morphology, and first device position predicted MVA after two implants (r = 0.82, P < .0001). Based on the mathematical relationship between these parameters, the minimal MVA needed in eight different clinical scenarios was summarized in a decision algorithm: the values ranged from 3.5 to 4.7 cm for one and 4.5 to 6.3 cm for two MC strategies.

Conclusions: The minimal native MVA preventing clinically relevant MS after transcatheter edge-to-edge repair is predicted by the number and location of clip(s), orifice morphology, and device type. Based on these parameters, an algorithm has been derived to optimize patient selection and preprocedural planning.
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http://dx.doi.org/10.1016/j.echo.2021.08.021DOI Listing
January 2022

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

Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR.

N Engl J Med 2021 12 28;385(23):2150-2160. Epub 2021 Aug 28.

From the Department of Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands (N.M.V.M., E.B.); Daiichi Sankyo, Basking Ridge, NJ (M.U., J.J., A.D., C.C.); the Department of Internal Medicine II, Division of Cardiology, Vienna General Hospital, Medical University, Vienna (C.H., I.L.); the Department of Internal Medicine, St. Johannes Hospital, Dortmund (H.M.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Internal Medicine-Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig (H.T.), Bremer Institute for Heart and Circulation Research at Klinikum Links der Weser, Bremen (R.H.), the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg (F.M.), Daiichi Sankyo Europe, Munich (P.L., H.L.), the Department of Neurology, Alfried Krupp Krankenhaus, Essen (R.V.), and the Department of Neurology, University Hospital Heidelberg, Heidelberg (R.V.) - all in Germany; Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York (R. Mehran, G.D.D.); the Department of Cardiology, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela (D.L.-O.), the Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos (L.N.-F.), the Department of Cardiology, University Hospital La Paz (R. Moreno), and the Department of Cardiology, University Hospital Ramon y Cajal (J.L.Z.), Madrid - all in Spain; the Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.S.); the Department of Cardiology, Toyohashi Heart Center, Toyohashi (M.Y.), the Department of Cardiology, Teikyo University School of Medicine (Y.W.), and the Department of Cardiology, Keio University School of Medicine (K.H.), Tokyo, and the Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura (S.S.) - all in Japan; the Department of Cardiology, Jessa Hospital, Hasselt, Belgium (P.V.); Quebec Heart and Lung Institute, Laval University, Quebec, QC, Canada (J.R.-C.); the Division of Cardiovascular Medicine, University Hospital of Strasbourg, Strasbourg, France (P.O.); the Division of Cardiology, Policlinico Hospital, University of Catania, Catania, Italy (P.C.); the Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea (H.-S.K.); the Department of Cardiology, University of Bern, Bern (T.P.), and Cardiocentro Ticino Institute and Department of Biomedical Sciences, University of Italian Switzerland, Lugano (M.V.) - both in Switzerland; the Department of Cardiology, University Hospital of Wales, Cardiff (R.A.), and the Division of Brain Sciences, Imperial College London, London (R.V.) - both in the United Kingdom; the Cardiology Section, University of Oklahoma Health Sciences Center, Oklahoma City (U.B.); and National and Kapodistrian University of Athens, School of Medicine, Athens (G.D.D.).

Background: The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied.

Methods: We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding.

Results: A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P = 0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P = 0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11).

Conclusions: In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).
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http://dx.doi.org/10.1056/NEJMoa2111016DOI Listing
December 2021

Surgical versus transcatheter repair for secondary mitral regurgitation: A propensity score-matched cohorts comparison.

J Thorac Cardiovasc Surg 2021 Jul 28. Epub 2021 Jul 28.

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

Objectives: To compare the efficacy and clinical outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) and surgical mitral valve repair (SMVr) among patients with secondary mitral regurgitation (SMR).

Methods: Consecutive patients with SMR treated using either TMVr (n = 199) or SMVr (n = 222) at 2 centers were included and retrospectively analyzed. To account for differences in patient demographic characteristics, 1:1 propensity score matching was performed. The primary endpoint was all-cause death within 2 years after the procedure.

Results: The study population consisted of 202 matched patients. At 2 years, all-cause mortality was 24.3% for TMVr and 23.0% for SMVr (hazard ratio, 0.97; 95% confidence interval, 0.55-1.71; P = .909). Severe heart failure symptoms at 2 years were less prevalent after SMVr (New York Heart Association functional class III or IV: 13.5% vs 29.5%; P = .032) than after TMVr. A higher proportion of the SMVr patients had SMR reduction to none or mild at discharge (90.8% vs 72.0%; P < .001) and 2 years (86.5% vs 59.6%; P < .001). Among patients who achieved none or mild MR at discharge, 7 patients (10.1%) in the SMVr group and 15 (34.9%) in the TMVr group had progression to moderate or greater MR at 2 years (P = .003). Left ventricular ejection fraction (LVEF) significantly improved (+10.1% ± 11.1%; P < .001) after SMVr (LVEF at 2 years: 45.7% ± 12.8%), whereas it remained unchanged (-1.3% ± 8.9%; P = .260) after TMVr (LVEF at 2 years: 34.0% ± 13.2%).

Conclusions: In this propensity score-matched analysis, there was no significant difference in 2-year survival between TMVr and SMVr, despite greater and more durable SMR reduction, as well as LVEF improvement in the surgical group.
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http://dx.doi.org/10.1016/j.jtcvs.2021.07.029DOI Listing
July 2021

Permanent pacemaker implantation late after transcatheter aortic valve implantation.

Heart Rhythm 2021 12 16;18(12):2033-2039. Epub 2021 Aug 16.

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

Background: Impairment of atrioventricular (AV) conduction may occur late after transcatheter aortic valve implantation (TAVI), and progression to complete AV block is a matter of concern.

Objective: The purpose of this study was to describe the incidence of permanent pacemaker (PPM) implantation late after TAVI.

Methods: In a prospective TAVI registry, we retrospectively identified patients with PPM implantation after hospital discharge for TAVI and analyzed serial electrocardiograms for AV conduction impairment before PPM implantation.

Results: Among 1059 patients discharged after TAVI without PPM between January 2012 and December 2017, 62 patients (5.9%) underwent PPM implantation at a median of 305 days after discharge for TAVI. Indications for PPM implantation late after TAVI were AV conduction impairment in 46 patients (74.2%); sick sinus syndrome in 10 (16.1%); cardiac resynchronization or implantable cardioverter-defibrillator indication in 2 (3.2%); and a pace and ablate strategy in 4 (6.5%). Clinical symptoms leading to PPM implantation late after TAVI included syncope in 19 patients (30.7%), presyncope in 7 (11.3%), and dyspnea in 8 (12.9%). First-degree AV block and new left bundle branch block (LBBB) after TAVI as well as valve-in-valve procedure during follow-up were independent predictors of PPM implantation late after TAVI due to AV conduction impairment.

Conclusion: PPM implantation late after TAVI is infrequent and is associated with clinical symptoms in half of patients. Impairment of AV conduction was the indication in three-quarters of patients. First-degree AV block and new LBBB after TAVI as well as valve-in-valve procedure during follow-up emerged as independent predictors.
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http://dx.doi.org/10.1016/j.hrthm.2021.08.010DOI Listing
December 2021

Integrative echocardiographic assessment of patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair.

Catheter Cardiovasc Interv 2021 12 18;98(7):1404-1412. Epub 2021 Aug 18.

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

Objectives: To investigate whether the integrative echocardiographic criteria used in the cardiovascular outcomes assessment of the mitraclip percutaneous therapy (COAPT) for heart failure patients with functional mitral regurgitation study predict outcomes after edge-to-edge trancatheter mitral valve repair (TMVr) for the treatment of secondary mitral regurgitation (SMR).

Background: Two randomized controlled trials comparing TMVr to medical treatment reported conflicting findings. Differences in patient selection criteria may have contributed to these diverging results.

Methods: Patients undergoing TMVr were stratified following the integrative COAPT echocardiographic criteria in noneligible and eligible patients who were further classified into three tiers according to effective regurgitant orifice (EROA) (Tier 1: EROA ≥ 0.3cm ; Tier 2: EROA 0.2cm and 0.29cm ; Tier 3: EROA<0.2cm ) combined with several other severity criteria. We assessed between group differences in all-cause mortality, successful SMR reduction, and symptom relief from baseline to 2-year follow-up.

Results: Between March 2011 and March 2018, 138 patients (mean age 75 years) satisfying the inclusion criteria underwent TMVr for treatment of symptomatic SMR. The mean EROA area was 0.35 ± 0.17 mm . Ten patients (7%) died within 30 days, 29 (21%) within 12 months, and 41 (30%) within 2 years. After stratification according to the COAPT echocardiographic criteria that were fulfilled in 72% of the studied population, Tier 2 patients (45%), as well as noneligible patients (38%) had a higher mortality rate compared to those in Tier 1 (19%).

Conclusions: SMR patients stratified into tiers according to the COAPT integrative echocardiographic criteria have diverging prognostic and symptomatic benefit after edge-to-edge TMVr.
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http://dx.doi.org/10.1002/ccd.29916DOI Listing
December 2021

Pulmonary Artery Pressure Ventricularization in a Patient With Carcinoid Heart Disease.

JACC Case Rep 2020 Jul 15;2(8):1200-1204. Epub 2020 Jul 15.

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

Ventricularization of the pulmonary artery pressure curve is shown, characterized by a steep diastolic pressure fall with mid-diastolic pressure equalization with the right ventricle, which was caused by severe pulmonary valvular regurgitation in a patient with carcinoid heart syndrome. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.05.057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311688PMC
July 2020

Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR.

JACC Cardiovasc Interv 2021 07;14(14):1578-1590

Department of Cardiology, St. Johannes Hospital, Dortmund, Germany.

Objectives: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR).

Background: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences.

Methods: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included.

Results: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement.

Conclusions: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality.
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http://dx.doi.org/10.1016/j.jcin.2021.05.007DOI Listing
July 2021

Effect of Paroxetine-Mediated G-Protein Receptor Kinase 2 Inhibition vs Placebo in Patients With Anterior Myocardial Infarction: A Randomized Clinical Trial.

JAMA Cardiol 2021 10;6(10):1171-1176

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

Importance: Left ventricular remodeling following acute myocardial infarction results in progressive myocardial dysfunction and adversely affects prognosis.

Objective: To investigate the efficacy of paroxetine-mediated G-protein-coupled receptor kinase 2 inhibition to mitigate adverse left ventricular remodeling in patients presenting with acute myocardial infarction.

Design, Setting, And Participants: This double-blind, placebo-controlled randomized clinical trial was conducted at Bern University Hospital, Bern, Switzerland. Patients with acute anterior ST-segment elevation myocardial infarction with left ventricular ejection fraction (LVEF) of 45% or less were randomly allocated to 2 study arms between October 26, 2017, and September 21, 2020.

Interventions: Patients in the experimental arm received 20 mg of paroxetine daily; patients in the control group received a placebo daily. Both treatments were provided for 12 weeks.

Main Outcomes And Measures: The primary end point was the difference in patient-level improvement of LVEF between baseline and 12 weeks as assessed by cardiac magnetic resonance tomography. Secondary end points were changes in left ventricular dimensions and late gadolinium enhancement between baseline and follow-up.

Results: Fifty patients (mean [SD] age, 62 [13] years; 41 men [82%]) with acute anterior myocardial infarction were randomly allocated to paroxetine or placebo, of whom 38 patients underwent cardiac magnetic resonance imaging both at baseline and 12 weeks. There was no difference in recovery of LVEF between the experimental group (mean [SD] change, 4.0% [7.0%]) and the control group (mean [SD] change, 6.3% [6.3%]; mean difference, -2.4% [95% CI, -6.8% to 2.1%]; P = .29) or changes in left ventricular end-diastolic volume (mean difference, 13.4 [95% CI, -12.3 to 39.0] mL; P = .30) and end-systolic volume (mean difference, 11.4 [95% CI, -3.6 to 26.4] mL; P = .13). Late gadolinium enhancement as a percentage of the total left ventricular mass decreased to a larger extent in the experimental group (mean [SD], -13.6% [12.9%]) compared with the control group (mean [SD], -4.5% [9.5%]; mean difference, -9.1% [95% CI, -16.6% to -1.6%]; P = .02).

Conclusions And Relevance: In this trial, treatment with paroxetine did not improve LVEF after myocardial infarction compared with placebo.

Trial Registration: ClinicalTrials.gov Identifier: NCT03274752.
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http://dx.doi.org/10.1001/jamacardio.2021.2247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8281020PMC
October 2021

Systemic corticosteroid exposure and atrioventricular conductance delays after transcatheter aortic valve implantation.

Cardiovasc Revasc Med 2021 Jul 1. Epub 2021 Jul 1.

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

Background: Atrioventricular conduction delays (AVCD) are common after transcatheter aortic valve implantation (TAVI) and frequently require implantation of a permanent pacemaker (PPM). Autopsy studies demonstrated the role of ischemia, inflammation, and oedema in the pathogenesis of AVCD. Corticosteroids (CS) reduce inflammation and oedema and hence might lead to a lower rate of AVCD.

Methods: Based on a prospective single-center registry, we performed a propensity score (PS) matched analysis of subjects treated with or without systemic CS (>2.5 mg prednisolone-equivalent per day) at the time of TAVI. The primary endpoint was a composite of PPM-implantation and new-onset left bundle branch block (LBBB) within 30 days after TAVI.

Results: Among 2213 consecutive patients undergoing TAVI (51.5% female, mean age 82.1 ± 6.1 years) 89 patients were treated with systemic CS, of which 87 were included in the PS matched analysis. At 30 days, rates of the composite of PPM and LBBB were comparable between patients with versus without CS both in the overall cohort (33.7% versus 33.0%, p = 0.89) and the PS matched cohort (34.5% versus 40.2%, p = 0.443). There were no differences in a composite of major or minor vascular complications and major or life-threatening bleeding events between patients with versus without CS in the overall cohort (34.8% versus 26.6%, p = 0.088) or the PS matched cohort (33.3% versus 33.3%, p ≥ 0.999).

Conclusion: In this exploratory study, intake of systemic CS among patients undergoing TAVI was not associated with differences in rates of AVCD, vascular complications, or bleeding events after TAVI.
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http://dx.doi.org/10.1016/j.carrev.2021.06.127DOI Listing
July 2021

Anaesthesia for minimally invasive cardiac procedures in the catheterization lab.

Curr Opin Anaesthesiol 2021 Aug;34(4):437-442

Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Purpose Of Review: The share of cardiac procedures performed in settings involving nonoperating room anaesthesia (NORA) continues to grow rapidly, and the number of publications related to anaesthetic techniques in cardiac catheterization laboratories is substantial. We aim to summarize the most recent evidence about outcomes related to type of anaesthetic in minimally invasive cardiac procedures.

Recent Findings: The latest studies, primarily focused on transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVr), demonstrate the need for reliable monitoring and appropriate training of the interdisciplinary teams involved in this high-risk NORA setting.

Summary: Inappropriate sedation and concurrent inadequate oxygenation are main risk factors for claims involving NORA care. Current evidence deriving from TAVR shows that monitored anaesthesia care (MAC) is associated with shorter length of stay and lower mortality.
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http://dx.doi.org/10.1097/ACO.0000000000001007DOI Listing
August 2021

The impact of obesity on left ventricular hypertrophy and diastolic dysfunction in children and adolescents.

Sci Rep 2021 06 22;11(1):13022. Epub 2021 Jun 22.

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

Childhood obesity continues to escalate worldwide and may affect left ventricular (LV) geometry and function. The aim of this study was to investigate the impact of obesity on prevalence of left ventricular hypertrophy (LVH) and diastolic dysfunction in children. In this analysis of prospectively collected cross-sectional data of children between 5 and 16 years of age from randomly selected schools in Peru, parameters of LV geometry and function were compared according to presence or absence of obesity (body mass index z-score > 2). LVH was based on left ventricular mass index (LVMI) adjusted for age and sex and defined by a z-score of > 2. LV diastolic function was assessed using mitral inflow early-to-late diastolic flow (E/A) ratio, peak early diastolic tissue velocities of the lateral mitral annulus (E'), early diastolic transmitral flow velocity to tissue Doppler mitral annular early diastolic velocity (E/E') ratio, and left atrial volume index (LAVI). Among 1023 children, 681 children (mean age 12.2 ± 3.1 years, 341 male (50.1%)) were available for the present analysis, of which 150 (22.0%) were obese. LVH was found in 21 (14.0%) obese and in 19 (3.6%) non-obese children (p < 0.001). LVMI was greater in obese than that in non-obese children (36.1 ± 8.6 versus 28.7 ± 6.9 g/m, p < 0.001). The mean mitral E/E' ratio and LAVI were significantly higher in obese than those in non-obese individuals (E/E': 5.2 ± 1.1 versus 4.9 ± 0.8, p = 0.043; LAVI 11.0 ± 3.2 versus 9.6 ± 2.9, p = 0.001), whereas E' and E/A ratio were comparable. Childhood obesity was associated with left ventricular hypertrophy and determinants of diastolic dysfunction.ClinicalTrials.gov Identifier: NCT02353663.
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http://dx.doi.org/10.1038/s41598-021-92463-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219764PMC
June 2021

Impact of clinical presentation on bleeding risk after percutaneous coronary intervention and implications for the ARC-HBR definition.

EuroIntervention 2021 Dec 3;17(11):e898-e909. Epub 2021 Dec 3.

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

Background: The identification of bleeding risk factors in patients undergoing percutaneous coronary intervention (PCI) is essential to inform subsequent management. Whether clinical presentation per se affects bleeding risk after PCI remains unclear.

Aims: We aimed to assess whether clinical presentation per se predisposes to bleeding in patients undergoing PCI and if the Academic Research Consortium (ARC) High Bleeding Risk (HBR) criteria perform consistently in acute (ACS) and chronic (CCS) coronary syndrome patients.

Methods: Consecutive patients undergoing PCI from the Bern PCI Registry were stratified by clinical presentation. Bleeding events at one year were compared in ACS versus CCS patients, and the originally defined ARC-HBR criteria were assessed.

Results: Among 16,821 patients, 9,503 (56.5%) presented with ACS. At one year, BARC 3 or 5 bleeding occurred in 4.97% and 3.60% of patients with ACS and CCS, respectively. After adjustment, ACS remained associated with higher BARC 3 or 5 bleeding risk (adjusted HR 1.21, 95% CI: 1.01-1.43; p=0.034), owing to non-access site-related occurrences, which accrued mainly within the first 30 days after PCI. The ARC-HBR score had lower discrimination among ACS compared with CCS patients, and its performance slightly improved when ACS was computed as a minor criterion.

Conclusions: ACS presentation per se predicts one-year major bleeding risk after PCI. The ARC-HBR score discrimination appeared lower in ACS than CCS, and its overall performance improved numerically when ACS was computed as an additional minor risk criterion.
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http://dx.doi.org/10.4244/EIJ-D-21-00181DOI Listing
December 2021

Sex-Based Differences in Bleeding Risk After Percutaneous Coronary Intervention and Implications for the Academic Research Consortium High Bleeding Risk Criteria.

J Am Heart Assoc 2021 06 8;10(12):e021965. Epub 2021 Jun 8.

Department of Cardiology Bern University Hospital Bern Switzerland.

Background Female sex was not included among the high bleeding risk (HBR) criteria by the Academic Research Consortium (ARC) as it remains unclear whether it constitutes an HBR condition after percutaneous coronary intervention. We investigated whether female sex associates with HBR and assessed the performance of ARC HBR criteria separately in women and men. Methods and Results Among all consecutive patients undergoing percutaneous coronary intervention between 2009 and 2018, bleeding occurrences up to 1 year were prospectively collected and centrally adjudicated. All but one of the originally defined ARC HBR criteria were assessed, and the ARC HBR score generated accordingly. Among 16 821 patients, 25.6% were women. Compared with men, women were older and had lower creatinine clearance and hemoglobin values. After adjustment, female sex was independently associated with access-site (adjusted hazard ratio, 2.14; 95% CI, 1.22-3.74; =0.008) but not with overall or non-access-site 1-year Bleeding Academic Research Consortium 3 or 5 bleeding. This association remained consistent when the femoral but not the radial approach was chosen. The ARC HBR score discrimination, using the original criteria, was lower among women than men (c-index 0.644 versus 0.688; =0.048), whereas a revised ARC HBR score, in which age, creatinine clearance, and hemoglobin were modeled as continuous rather than dichotomized variables, performed similarly in both sexes. Conclusions Female sex is an independent predictor for access-site bleeding but not for overall bleeding events at 1 year after percutaneous coronary intervention. The ARC HBR framework shows an overall good performance in both sexes, yet is lower in women than men, attributable to dichotomization of age, creatinine clearance, and hemoglobin values, which are differently distributed between sexes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.
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http://dx.doi.org/10.1161/JAHA.121.021965DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8477884PMC
June 2021

Refined staging classification of cardiac damage associated with aortic stenosis and outcomes after transcatheter aortic valve implantation.

Eur Heart J Qual Care Clin Outcomes 2021 Oct;7(6):532-541

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

Aims : A new staging classification of aortic stenosis (AS) characterizing the extent of cardiac damage was established and validated in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to validate an updated classification system in patients undergoing TAVI.

Methods And Results: In a prospective TAVI registry, AS patients were categorized into the following stages: no cardiac damage (Stage 0), left ventricular damage (Stage 1), left atrial or mitral valve damage (Stage 2), pulmonary vasculature or tricuspid valve damage (Stage 3), or right ventricular (RV) damage or low-flow state (Stage 4). Stage 3 was sub-divided into Stage 3a (≤moderate pulmonary hypertension) and Stage 3b (severe pulmonary hypertension). Stage 4 was sub-divided into Stage 4a (low-flow without RV dysfunction), Stage 4b (RV dysfunction without low-flow), and Stage 4c (RV dysfunction with low-flow). The primary endpoint was all-cause death at 1 year. Among 1156 eligible patients, 14 were classified as Stage 0, 38 as Stage 1, 105 as Stage 2278 as Stage 3, and 721 as Stage 4. There was a stepwise increase in mortality according to advancing stages of cardiac damage: 3.9% (Stage 0-1), 9.6% (Stage 2), 14.1% (Stage 3), and 17.4% (Stage 4) (P = 0.002). After multivariable adjustment, only Stage 3b, Stage 4b, and Stage 4c conferred a significantly increased risk of mortality compared to Stage 0-1.

Conclusion : More than one-third of patients had advanced cardiac damage (severe pulmonary hypertension or RV dysfunction) before TAVI, associating with a five- to seven-fold increased risk of mortality at 1 year.

Clinical Trial Registration: https://www.clinicaltrials.gov. NCT01368250.
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http://dx.doi.org/10.1093/ehjqcco/qcab041DOI Listing
October 2021
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