Publications by authors named "Christoph Kaiser"

170 Publications

Case Report: Nakalanga Syndrome Revisited: Long-Term Follow-Up of a Patient Living in Western Uganda, 1994-2018.

Am J Trop Med Hyg 2020 Dec 21. Epub 2020 Dec 21.

Department of Pediatrics, Regional Referral Hospital, Fort Portal, Uganda.

Nakalanga syndrome is a childhood developmental disorder that has been reported from various parts of sub-Saharan Africa with the major sign of retarded growth, regularly combined with physical deformities, impaired mental and pubertal development, and epilepsy. We present a follow-up over a 24-year period of a patient living in the Itwara onchocerciasis focus of western Uganda. We demonstrate the strong similarity of Nakalanga syndrome to the more recently described Nodding syndrome, and we discuss the possible causation of both disorders by onchocerciasis. We suggest that the growing knowledge about the tight interconnections between Nakalanga and nodding syndrome, other forms of epilepsy, and onchocerciasis should be taken into consideration in a revised classification system.
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http://dx.doi.org/10.4269/ajtmh.20-0979DOI Listing
December 2020

Effect of COVID-19 on acute treatment of ST-segment elevation and Non-ST-segment elevation acute coronary syndrome in northwestern Switzerland.

Int J Cardiol Heart Vasc 2021 Feb 4;32:100686. Epub 2020 Dec 4.

Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Switzerland.

Background: To investigate the effect of the corona virus disease 2019 (COVID-19) pandemic on the acute treatment of patients with ST-segment elevation (STEMI) and Non-ST-segment elevation acute coronary syndrome (NSTE-ACS).

Methods: We retrospectively identified patients presenting to the emergency department (ED) with suspected ACS. We evaluated the number of percutaneous coronary interventions (PCIs) for STEMI, NSTE-ACS, and elective PCI cases. In STEMI patients, we assessed the time from chest pain onset (cpo) to ED presentation, post-infarction left ventricular ejection fraction (LVEF), and time from ED presentation to PCI. We directly compared cases from two time intervals: January/February 2020 versus March/April 2020 (defined as 2 months before and after the COVID-19 outbreak). In a secondary analysis, we directly compared cases from March/April 2020 with patients from the same time interval in 2019.

Results: From January to April 2020, 765 patients presented with acute chest pain to the ED. A dramatic reduction of ED presentations after compared to before the COVID-19 outbreak (31% relative reduction) was observed. Overall, 398 PCIs were performed, 220/398 PCIs (55.3%) before versus 178/398 PCIs (44.7%) after the outbreak. While numbers for NSTE-ACS and elective interventions declined by 21% and 31%, respectively, the number of STEMI cases remained stable. Time from cpo to ED presentation, post-infarction LVEF, and median door-to-balloon time remained unchanged.

Conclusions: In contrast to previous reports, our findings do not confirm the dramatic drop in STEMI cases and interventions in northwestern Switzerland as observed in other regions and hospitals around the world.
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http://dx.doi.org/10.1016/j.ijcha.2020.100686DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734221PMC
February 2021

Prognostic value of texture analysis from cardiac magnetic resonance imaging in patients with Takotsubo syndrome: a machine learning based proof-of-principle approach.

Sci Rep 2020 11 25;10(1):20537. Epub 2020 Nov 25.

Acute Cardiac Care, Andreas Grüntzig Heart Catheterization Laboratories, Department of Cardiology, University Heart Center, University Hospital Zurich, University of Zurich, Raemistrasse 100, 8091, Zurich, Switzerland.

Cardiac magnetic resonance (CMR) imaging has become an important technique for non-invasive diagnosis of takotsubo syndrome (TTS). The long-term prognostic value of CMR imaging in TTS has not been fully elucidated yet. This study sought to evaluate the prognostic value of texture analysis (TA) based on CMR images in patients with TTS using machine learning. In this multicenter study (InterTAK Registry), we investigated CMR imaging data of 58 patients (56 women, mean age 68 ± 12 years) with TTS. CMR imaging was performed in the acute to subacute phase (median time after symptom onset 4 days) of TTS. TA of the left ventricle was performed using free-hand regions-of-interest in short axis late gadolinium-enhanced and on T2-weighted (T2w) images. A total of 608 TA features adding the parameters age, gender, and body mass index were included. Dimension reduction was performed removing TA features with poor intra-class correlation coefficients (ICC ≤ 0.6) and those being redundant (correlation matrix with Pearson correlation coefficient r > 0.8). Five common machine-learning classifiers (artificial neural network Multilayer Perceptron, decision tree J48, NaïveBayes, RandomForest, and Sequential Minimal Optimization) with tenfold cross-validation were applied to assess 5-year outcome including major adverse cardiac and cerebrovascular events (MACCE). Dimension reduction yielded 10 TA features carrying prognostic information, which were all based on T2w images. The NaïveBayes machine learning classifier showed overall best performance with a sensitivity of 82.9% (confidence interval (CI) 80-86.2), specificity of 83.7% (CI 75.7-92), and an area-under-the receiver operating characteristics curve of 0.88 (CI 0.83-0.92). This proof-of-principle study is the first to identify unique T2w-derived TA features that predict long-term outcome in patients with TTS. These features might serve as imaging prognostic biomarkers in TTS patients.
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http://dx.doi.org/10.1038/s41598-020-76432-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689426PMC
November 2020

Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial.

Lancet 2020 11 19;396(10261):1504-1510. Epub 2020 Oct 19.

University Hospital Saarland, Homburg, Germany.

Background: In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention.

Methods: In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing.

Findings: Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance.

Interpretation: There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.

Funding: Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.
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http://dx.doi.org/10.1016/S0140-6736(20)32173-5DOI Listing
November 2020

Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial.

J Am Heart Assoc 2020 10 9;9(20):e017434. Epub 2020 Oct 9.

University Hospital Basel Switzerland.

Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64, =0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68, <0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74, =0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8], =0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00595647.
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http://dx.doi.org/10.1161/JAHA.120.017434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763393PMC
October 2020

Technical success, resection status, and procedural complication rate of colonoscopic full-wall resection: a pooled analysis from 7 hospitals of different care levels.

Surg Endosc 2020 Jul 9. Epub 2020 Jul 9.

Department of Gastroenterology, Hepatology and Gastrointestinal Oncology, Bogenhausen Academic Teaching Hospital, Technical University of Munich, Munich, Germany.

Introduction: Endoscopic full-thickness resection (eFTR) using the full-thickness resection device (FTRD®) is a novel minimally invasive procedure that allows the resection of various lesions in the gastrointestinal tract including the colorectum. Real-world data outside of published studies are limited. The aim of this study was a detailed analysis of the outcomes of colonoscopic eFTR in different hospitals from different care levels in correlation with the number of endoscopists performing eFTR.

Material And Methods: In this case series, the data of all patients who underwent eFTR between November 2014 and June 2019 (performed by a total of 22 endoscopists) in 7 hospitals were analyzed retrospectively regarding rates of technical success, R0 resection, and procedure-related complications.

Results: Colonoscopic eFTR was performed in 229 patients (64.6% men; average age 69.3 ± 10.3 years) mainly on the basis of the following indication: 69.9% difficult adenomas, 21.0% gastrointestinal adenocarcinomas, and 7.9% subepithelial tumors. The average size of the lesions was 16.3 mm. Technical success rate of eFTR was achieved in 83.8% (binominal confidence interval 78.4-88.4%). Overall, histologically complete resection (R0) was achieved in 77.2% (CI 69.8-83.6%) while histologically proven full-wall excidate was confirmed in 90.0% (CI 85.1-93.7%). Of the resectates obtained (n = 210), 190 were resected en bloc (90.5%). We did not observe a clear improvement of technical success and R0 resection rate over time by the performing endoscopists. Altogether, procedure-related complications were observed in 17.5% (mostly moderate) including 2 cases of acute gangrenous appendicitis requiring operation.

Discussion: In this pooled analysis, eFTR represents a feasible, effective, and safe minimally invasive endoscopic technique.
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http://dx.doi.org/10.1007/s00464-020-07772-5DOI Listing
July 2020

Changes in epilepsy burden after onchocerciasis elimination in a hyperendemic focus of western Uganda: a comparison of two population-based, cross-sectional studies.

Lancet Infect Dis 2020 11 26;20(11):1315-1323. Epub 2020 Jun 26.

Global Health Institute, University of Antwerp, Belgium. Electronic address:

Background: In 1994, prevalence and incidence of epilepsy were high in the Itwara onchocerciasis focus (western Uganda), and cases of nodding and Nakalanga syndrome were documented. Onchocerciasis transmission was interrupted successfully in 2001. 17 years later, we re-investigated the epilepsy burden in this area.

Methods: From Dec 11 to Dec 15, 2018, a door-to-door survey was done in the three villages (Kabende Centre, Masongora South, and Rwesenene) with the highest epilepsy rates in 1994 to identify people with suspected epilepsy. Epilepsy diagnoses were confirmed by an interview and physical examination by a study clinician. The prevalence and incidence of epilepsy were measured using methods consistent with those used in 1994. Results from 2018 were compared with those from 1994.

Findings: The overall crude prevalence of epilepsy in the study villages decreased from 3·0% (35 of 1169) in 1994 to 1·2% (27 of 2325) in 2018 (p=0·0002), with a concomitant decrease in the proportion of people with epilepsy with unknown cause (p=0·037). Between 1994 and 2018, the overall incidence of epilepsy decreased from 418 cases per 100 000 person-years (95% CI 265-626) to 73 new cases per 100 000 person-years (32-114; p<0·0001); this reduction was more pronounced for cases having the first seizure between ages 3 years and 18 years (p<0·0001). No new case of nodding or Nakalanga syndromes had occurred since the interruption of onchocerciasis transmission.

Interpretation: Our findings support the existence of a negative association between onchocerciasis elimination and epilepsy burden in previously hyperendemic areas. Therefore, onchocerciasis elimination efforts should be intensified in endemic regions with a high prevalence of epilepsy, which might reduce the burden of epilepsy.

Funding: Flemish University Development Cooperation and the European Research Council.
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http://dx.doi.org/10.1016/S1473-3099(20)30122-5DOI Listing
November 2020

Causes of death after treatment of small coronary artery disease with paclitaxel-coated balloons.

Clin Res Cardiol 2021 02 4;110(2):307-311. Epub 2020 Jun 4.

Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany.

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http://dx.doi.org/10.1007/s00392-020-01674-1DOI Listing
February 2021

Coexistence and outcome of coronary artery disease in Takotsubo syndrome.

Authors:
L Christian Napp Victoria L Cammann Milosz Jaguszewski Konrad A Szawan Manfred Wischnewsky Sebastiano Gili Maike Knorr Susanne Heiner Rodolfo Citro Eduardo Bossone Fabrizio D'Ascenzo Michael Neuhaus Jennifer Franke Ioana Sorici-Barb Michel Noutsias Christof Burgdorf Wolfgang Koenig Behrouz Kherad Annahita Sarcon Lawrence Rajan Guido Michels Roman Pfister Alessandro Cuneo Claudius Jacobshagen Mahir Karakas Alexander Pott Philippe Meyer Jose D Arroja Adrian Banning Florim Cuculi Richard Kobza Thomas A Fischer Tuija Vasankari K E Juhani Airaksinen Christian Hauck Carla Paolini Claudio Bilato Yoichi Imori Ken Kato Yoshio Kobayashi Grzegorz Opolski Monika Budnik Rafal Dworakowski Philip MacCarthy Christoph Kaiser Stefan Osswald Leonarda Galiuto Wolfgang Dichtl Christina Chan Paul Bridgman Daniel Beug Clément Delmas Olivier Lairez Ibrahim El-Battrawy Ibrahim Akin Ekaterina Gilyarova Alexandra Shilova Mikhail Gilyarov John D Horowitz Karolina Polednikova Petr Tousek Petr Widimský David E Winchester Jan Galuszka Christian Ukena Gregor Poglajen Pedro Carrilho-Ferreira Carlo Di Mario Abhiram Prasad Charanjit S Rihal P Christian Schulze Matteo Bianco Filippo Crea Martin Borggrefe Lars S Maier Fausto J Pinto Ruediger C Braun-Dullaeus Wolfgang Rottbauer Hugo A Katus Gerd Hasenfuß Carsten Tschöpe Burkert M Pieske Holger Thiele Heribert Schunkert Michael Böhm Stephan B Felix Thomas Münzel Jeroen J Bax Johann Bauersachs Eugene Braunwald Thomas F Lüscher Frank Ruschitzka Jelena R Ghadri Christian Templin

Eur Heart J 2020 Sep;41(34):3255-3268

University Heart Center, Department of Cardiology, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland.

Aims: Takotsubo syndrome (TTS) is an acute heart failure syndrome, which shares many features with acute coronary syndrome (ACS). Although TTS was initially described with angiographically normal coronary arteries, smaller studies recently indicated a potential coexistence of coronary artery disease (CAD) in TTS patients. This study aimed to determine the coexistence, features, and prognostic role of CAD in a large cohort of patients with TTS.

Methods And Results: Coronary anatomy and CAD were studied in patients diagnosed with TTS. Inclusion criteria were compliance with the International Takotsubo Diagnostic Criteria for TTS, and availability of original coronary angiographies with ventriculography performed during the acute phase. Exclusion criteria were missing views, poor quality of angiography loops, and angiography without ventriculography. A total of 1016 TTS patients were studied. Of those, 23.0% had obstructive CAD, 41.2% had non-obstructive CAD, and 35.7% had angiographically normal coronary arteries. A total of 47 patients (4.6%) underwent percutaneous coronary intervention, and 3 patients had acute and 8 had chronic coronary artery occlusion concomitant with TTS, respectively. The presence of CAD was associated with increased incidence of shock, ventilation, and death from any cause. After adjusting for confounders, the presence of obstructive CAD was associated with mortality at 30 days. Takotsubo syndrome patients with obstructive CAD were at comparable risk for shock and death and nearly at twice the risk for ventilation compared to an age- and sex-matched ACS cohort.

Conclusions: Coronary artery disease frequently coexists in TTS patients, presents with the whole spectrum of coronary pathology including acute coronary occlusion, and is associated with adverse outcome.

Trial Registration: ClinicalTrials.gov number: NCT01947621.
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http://dx.doi.org/10.1093/eurheartj/ehaa210DOI Listing
September 2020

Age-Related Variations in Takotsubo Syndrome.

Authors:
Victoria L Cammann Konrad A Szawan Barbara E Stähli Ken Kato Monika Budnik Manfred Wischnewsky Sara Dreiding Rena A Levinson Davide Di Vece Sebastiano Gili Rodolfo Citro Eduardo Bossone Michael Neuhaus Jennifer Franke Benjamin Meder Miłosz Jaguszewski Michel Noutsias Maike Knorr Susanne Heiner Fabrizio D'Ascenzo Wolfgang Dichtl Christof Burgdorf Behrouz Kherad Carsten Tschöpe Annahita Sarcon Jerold Shinbane Lawrence Rajan Guido Michels Roman Pfister Alessandro Cuneo Claudius Jacobshagen Mahir Karakas Wolfgang Koenig Alexander Pott Philippe Meyer Marco Roffi Adrian Banning Mathias Wolfrum Florim Cuculi Richard Kobza Thomas A Fischer Tuija Vasankari K E Juhani Airaksinen L Christian Napp Rafal Dworakowski Philip MacCarthy Christoph Kaiser Stefan Osswald Leonarda Galiuto Christina Chan Paul Bridgman Daniel Beug Clément Delmas Olivier Lairez Ekaterina Gilyarova Alexandra Shilova Mikhail Gilyarov Ibrahim El-Battrawy Ibrahim Akin Karolina Poledniková Petr Toušek David E Winchester Jan Galuszka Christian Ukena Gregor Poglajen Pedro Carrilho-Ferreira Christian Hauck Carla Paolini Claudio Bilato Yoshio Kobayashi Toshihiro Shoji Iwao Ishibashi Masayuki Takahara Toshiharu Himi Jehangir Din Ali Al-Shammari Abhiram Prasad Charanjit S Rihal Kan Liu P Christian Schulze Matteo Bianco Lucas Jörg Hans Rickli Gonçalo Pestana Thanh H Nguyen Michael Böhm Lars S Maier Fausto J Pinto Petr Widimský Stephan B Felix Ruediger C Braun-Dullaeus Wolfgang Rottbauer Gerd Hasenfuß Burkert M Pieske Heribert Schunkert Martin Borggrefe Holger Thiele Johann Bauersachs Hugo A Katus John D Horowitz Carlo Di Mario Thomas Münzel Filippo Crea Jeroen J Bax Thomas F Lüscher Frank Ruschitzka Jelena R Ghadri Grzegorz Opolski Christian Templin

J Am Coll Cardiol 2020 04;75(16):1869-1877

University Heart Center, Department of Cardiology, University Hospital Zurich, Zurich, Switzerland. Electronic address:

Background: Takotsubo syndrome (TTS) occurs predominantly in post-menopausal women but is also found in younger patients.

Objectives: This study aimed to investigate age-related differences in TTS.

Methods: Patients diagnosed with TTS and enrolled in the International Takotsubo Registry between January 2011 and February 2017 were included in this analysis and were stratified by age (younger: ≤50 years, middle-age: 51 to 74 years, elderly: ≥75 years). Baseline characteristics, hospital course, as well as short- and long-term mortality were compared among groups.

Results: Of 2,098 TTS patients, 242 (11.5%) patients were ≤50 years of age, 1,194 (56.9%) were 51 to 74 years of age, and 662 (31.6%) were ≥75 years of age. Younger patients were more often men (12.4% vs. 10.9% vs. 6.3%; p = 0.002) and had an increased prevalence of acute neurological (16.3% vs. 8.4% vs. 8.8%; p = 0.001) or psychiatric disorders (14.1% vs. 10.3% vs. 5.6%; p < 0.001) compared with middle-aged and elderly TTS patients. Furthermore, younger patients had more often cardiogenic shock (15.3% vs. 9.1% vs. 8.1%; p = 0.004) and had a numerically higher in-hospital mortality (6.6% vs. 3.6% vs. 5.1%; p = 0.07). At multivariable analysis, younger (odds ratio: 1.60; 95% confidence interval: 0.86 to 3.01; p = 0.14) and older age (odds ratio: 1.09; 95% confidence interval: 0.66 to 1.80; p = 0.75) were not independently associated with in-hospital mortality using the middle-aged group as a reference. There were no differences in 60-day mortality rates among groups.

Conclusions: A substantial proportion of TTS patients are younger than 50 years of age. TTS is associated with severe complications requiring intensive care, particularly in younger patients.
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http://dx.doi.org/10.1016/j.jacc.2020.02.057DOI Listing
April 2020

A Randomized Trial of Recombinant Human C1-Esterase-Inhibitor in the Prevention of Contrast-Induced Kidney Injury.

JACC Cardiovasc Interv 2020 04 11;13(7):833-842. Epub 2020 Mar 11.

Division of Internal Medicine, University Hospital Basel, Basel, Switzerland; Department of Clinical Research and Department of Biomedicine, University of Basel, Basel, Switzerland. Electronic address:

Objectives: This study sought to determine the efficacy profile and safety of recombinant human C1 esterase inhibitor (rhC1INH) in the prevention of contrast-associated acute kidney injury after elective coronary angiography.

Background: Contrast-associated acute kidney injury is caused by tubular cytotoxicity and ischemia/reperfusion injury. rhC1INH is effective in reducing renal ischemia/reperfusion injury in experimental models.

Methods: In this placebo-controlled, double-blind, single-center trial 77 patients with chronic kidney disease were randomized to receive 50 IU/kg rhC1INH before and 4 h after elective coronary angiography or placebo. The primary outcome was the peak change of urinary neutrophil gelatinase-associated lipocalin within 48 h, a surrogate marker of kidney injury.

Results: Median peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = 0.039 corresponding to a median proportion peak change of 11% vs. 205%; p = 0.002). The incidence of a cystatin C increase ≥10% within 24 h was lower in the rhC1INH group (16% vs. 33%; p = 0.045), whereas the frequency of contrast-associated acute kidney injury was comparable. Adverse events during a 3-month follow-up were similarly distributed.

Conclusions: Administration of rhC1INH before coronary angiography may attenuate renal injury as reflected by urinary neutrophil gelatinase-associated lipocalin and cystatin C. The safety profile of rhC1INH was favorable in a patient population with multiple comorbidities. (Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects [PROTECT]; NCT02869347).
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http://dx.doi.org/10.1016/j.jcin.2019.11.021DOI Listing
April 2020

Electrophysiology Testing to Stratify Patients With Left Bundle Branch Block After Transcatheter Aortic Valve Implantation.

J Am Heart Assoc 2020 03 22;9(5):e014446. Epub 2020 Feb 22.

Cardiology/Electrophysiology University Hospital Basel University Basel Basel Switzerland.

Background Left bundle branch block (LBBB) is common after transcatheter aortic valve implantation (TAVI) and is an indicator of subsequent high-grade atrioventricular block (HAVB). No standardized protocol is available to identify LBBB patients at risk for HAVB. The aim of the current study was to evaluate the safety and efficacy of an electrophysiology study tailored strategy in patients with LBBB after TAVI. Methods and Results We prospectively analyzed consecutive patients with LBBB after TAVI. An electrophysiology study was performed to measure the HV-interval the day following TAVI. In patients with normal His-ventricular (HV)-interval ≤55 ms, a loop recorder was implanted (ILR-group), whereas pacemaker implantation was performed in patients with prolonged HV-interval >55 ms (PM-group). The primary end point was occurrence of HAVB during a follow-up of 12 months. Secondary end points were symptoms, hospitalizations, adverse events because of device implantation or electrophysiology study, and death. Of 373 patients screened after TAVI, 56 patients (82±6 years, 41% male) with LBBB were included. HAVB occurred in 4 of 41 patients (10%) in the ILR-group and in 8 of 15 patients (53%) in the PM-group (<0.001). We did not identify other predictors for HAVB than the HV interval. The negative predictive value for the cut-off of HV 55 ms to detect HAVB was 90%. No HAVB-related syncope occurred in the 2 groups. Conclusions An electrophysiology study tailored strategy to LBBB after TAVI with a cut-off of HV >55 ms is a feasible and safe approach to stratify patients with regard to developing HAVB during a follow-up of 12 months.
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http://dx.doi.org/10.1161/JAHA.119.014446DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335581PMC
March 2020

Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial.

Clin Res Cardiol 2020 Sep 29;109(9):1114-1124. Epub 2020 Jan 29.

Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland.

Background: The randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase.

Methods: Eight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints.

Results: One-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009).

Conclusions: The clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group.

Clinical Trial Registration: www.clinicaltrials.gov ; number, NCT01574534.
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http://dx.doi.org/10.1007/s00392-020-01603-2DOI Listing
September 2020

In vivo relationship between near-infrared spectroscopy-detected lipid-rich plaques and morphological plaque characteristics by optical coherence tomography and intravascular ultrasound: a multimodality intravascular imaging study.

Eur Heart J Cardiovasc Imaging 2020 Jan 28. Epub 2020 Jan 28.

Cardiology Department, Bern University Hospital, University of Bern, 3012 Bern, Switzerland.

Aims: We assessed morphological features of near-infrared spectroscopy (NIRS)-detected lipid-rich plaques (LRPs) by using optical coherence tomography (OCT) and intravascular ultrasound (IVUS).

Methods And Results: IVUS-NIRS and OCT were performed in the two non-infarct-related arteries (non-IRAs) in patients undergoing percutaneous coronary intervention for treatment of an acute coronary syndrome. A lesion was defined as the 4 mm segment with the maximum amount of lipid core burden index (maxLCBI4mm) of each LRP detected by NIRS. We divided the lesions into three groups based on the maxLCBI4mm value: <250, 250-399, and ≥400. OCT analysis and IVUS analysis were performed blinded for NIRS. We measured fibrous cap thickness (FCT) by using a semi-automated method. A total of 104 patients underwent multimodality imaging of 209 non-IRAs. NIRS detected 299 LRPs. Of those, 41% showed a maxLCBI4mm <250, 39% a maxLCBI4mm 251-399, and 19% a maxLCBI4mm ≥400. LRPs with a maxLCBI4mm ≥400, as compared with LRPs with a maxLCBI4mm 250-399 and <250, were more frequently thin-cap fibroatheroma (TCFA) (42.1% vs. 5.1% and 0.8%; P < 0.001) with a smaller minimum FCT (80 μm vs. 110 μm and 120 μm; P < 0.001); a higher IVUS-derived percent atheroma volume (53% vs. 53% and 44%; P < 0.001) and a higher remodelling index (1.08 vs. 1.02 and 1.01; P < 0.001). MaxLCBI4mm correlated with OCT-derived FCT (r = 0.404; P < 0.001) and was the best predictor for TCFA with an optimal cut-off value of 401 (area under the curve = 0.882; P < 0.001).

Conclusion: LRPs with increasing maxLCBI4mm exhibit OCT and IVUS features of presumed plaque vulnerability including TCFA morphology, increased plaque burden, and positive remodelling.
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http://dx.doi.org/10.1093/ehjci/jez318DOI Listing
January 2020

Drug-coated balloons in cardiovascular disease: benefits, challenges, and clinical applications.

Expert Opin Drug Deliv 2020 02 15;17(2):201-211. Epub 2020 Jan 15.

Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.

: Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, their efficacy is limited by in-stent restenosis and stent thrombosis. Drug-coated balloons (DCB) are a treatment option for in-stent-restenosis and for certain clinical and anatomical situations in de novo diseases such as small coronary arteries, bifurcation lesions, and high bleeding risk situations.: This review summarizes the current clinical status of DCB angioplasty in coronary artery disease.: DCB deliver an anti-proliferative drug into the vessel wall without implanting a stent and are a promising and technique in the treatment of coronary artery disease. Several studies and meta-analysis have demonstrated the safety and efficacy of DCB angioplasty for several indications such as in-stent restenosis, small-vessel disease, and high bleeding risk. Due to absent short- and long-term complications of stent implantation and a short dual antiplatelet therapy duration, DCB angioplasty has the potential to achieve a clear role in the interventional field in clinical settings with a comparable or even a superior efficacy in comparison with DES use.
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http://dx.doi.org/10.1080/17425247.2020.1714590DOI Listing
February 2020

Using High-Sensitivity Cardiac Troponin for the Exclusion of Inducible Myocardial Ischemia in Symptomatic Patients: A Cohort Study.

Ann Intern Med 2020 02 7;172(3):175-185. Epub 2020 Jan 7.

Cardiovascular Research Institute Basel, University Hospital Basel, and University of Basel, Basel, Switzerland (J.W., J.D., L.K., T.Z., J.B., U.H., I.S., R.T., M.A., T.N., D.W., C.P., M.Z., G.F., R.J., C.K., C.M.).

Background: The optimal noninvasive method for surveillance in symptomatic patients with stable coronary artery disease (CAD) is unknown.

Objective: To apply a novel approach using very low concentrations of high-sensitivity cardiac troponin I (hs-cTnI) for exclusion of inducible myocardial ischemia in symptomatic patients with CAD.

Design: Prospective diagnostic cohort study. (ClinicalTrials.gov: NCT01838148).

Setting: University hospital.

Patients: 1896 consecutive patients with CAD referred with symptoms possibly related to inducible myocardial ischemia.

Measurements: Presence of inducible myocardial ischemia was adjudicated using myocardial perfusion imaging with single-photon emission computed tomography, as well as coronary angiography and fractional flow reserve measurements where available. Staff blinded to adjudication measured circulating hs-cTn concentrations. An hs-cTnI cutoff of 2.5 ng/L, derived previously in mostly asymptomatic patients with CAD, was assessed. Predefined target performance criteria were at least 90% negative predictive value (NPV) and at least 90% sensitivity for exclusion of inducible myocardial ischemia. Sensitivity analyses were based on measurements with an hs-cTnT assay and an alternative hs-cTnI assay with even higher analytic sensitivity (limit of detection, 0.1 ng/L).

Results: Overall, 865 patients (46%) had inducible myocardial ischemia. The hs-cTnI cutoff of 2.5 ng/L provided an NPV of 70% (95% CI, 64% to 75%) and a sensitivity of 90% (CI, 88% to 92%) for exclusion of inducible myocardial ischemia. No hs-cTnI cutoff reached both performance characteristics predefined as targets. Similarly, using the alternative assays for hs-cTnI or hs-cTnT, no cutoff achieved the target performance: hs-cTnT concentrations less than 5 ng/L yielded an NPV of 66% (CI, 59% to 72%), and hs-cTnI concentrations less than 2 ng/L yielded an NPV of 68% (CI, 62% to 74%).

Limitation: Data were generated in a large single-center diagnostic study using central adjudication.

Conclusion: In symptomatic patients with CAD, very low hs-cTn concentrations, including hs-cTnI concentrations less than 2.5 ng/L, do not generally allow users to safely exclude inducible myocardial ischemia.

Primary Funding Source: European Union, Swiss National Science Foundation, Kommission für Technologie und Innovation (Innosuisse), Swiss Heart Foundation, Cardiovascular Research Foundation Basel, University of Basel, University Hospital Basel, Roche, Abbott, and Singulex.
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http://dx.doi.org/10.7326/M19-0080DOI Listing
February 2020

Impact of aspirin on takotsubo syndrome: a propensity score-based analysis of the InterTAK Registry.

Eur J Heart Fail 2020 02 20;22(2):330-337. Epub 2019 Dec 20.

Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.

Aims: The aim of the present study was to investigate the impact of aspirin on prognosis in takotsubo syndrome (TTS).

Methods And Results: Patients from the International Takotsubo (InterTAK) Registry were categorized into two groups based on aspirin prescription at discharge. A comparison of clinical outcomes between groups was performed using an adjusted analysis with propensity score (PS) stratification; results from the unadjusted analysis were also reported to note the effect of the PS adjustment. Major adverse cardiac and cerebrovascular events (MACCE: a composite of death, myocardial infarction, TTS recurrence, stroke or transient ischaemic attack) were assessed at 30-day and 5-year follow-up. A total of 1533 TTS patients with known status regarding aspirin prescription at discharge were included. According to the adjusted analysis based on PS stratification, aspirin was not associated with a lower hazard of MACCE at 30-day [hazard ratio (HR) 1.24, 95% confidence interval (CI) 0.50-3.04, P = 0.64] or 5-year follow-up (HR 1.11, 95% CI 0.78-1.58, P = 0.58). These results were confirmed by sensitivity analyses performed with alternative PS-based methods, i.e. covariate adjustment and inverse probability of treatment weighting.

Conclusion: In the present study, no association was found between aspirin use in TTS patients and a reduced risk of MACCE at 30-day and 5-year follow-up. These findings should be confirmed in adequately powered randomized controlled trials. ClinicalTrials.gov Identifier: NCT01947621.
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http://dx.doi.org/10.1002/ejhf.1698DOI Listing
February 2020

The structure and oxidation of the eye lens chaperone αA-crystallin.

Nat Struct Mol Biol 2019 12 2;26(12):1141-1150. Epub 2019 Dec 2.

Center for Integrated Protein Science Munich at the Department Chemie, Technische Universität München, Garching, Germany.

The small heat shock protein αA-crystallin is a molecular chaperone important for the optical properties of the vertebrate eye lens. It forms heterogeneous oligomeric ensembles. We determined the structures of human αA-crystallin oligomers by combining cryo-electron microscopy, cross-linking/mass spectrometry, NMR spectroscopy and molecular modeling. The different oligomers can be interconverted by the addition or subtraction of tetramers, leading to mainly 12-, 16- and 20-meric assemblies in which interactions between N-terminal regions are important. Cross-dimer domain-swapping of the C-terminal region is a determinant of αA-crystallin heterogeneity. Human αA-crystallin contains two cysteines, which can form an intramolecular disulfide in vivo. Oxidation in vitro requires conformational changes and oligomer dissociation. The oxidized oligomers, which are larger than reduced αA-crystallin and destabilized against unfolding, are active chaperones and can transfer the disulfide to destabilized substrate proteins. The insight into the structure and function of αA-crystallin provides a basis for understanding its role in the eye lens.
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http://dx.doi.org/10.1038/s41594-019-0332-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7115824PMC
December 2019

Intraventricular Thrombus Formation and Embolism in Takotsubo Syndrome: Insights From the International Takotsubo Registry.

Arterioscler Thromb Vasc Biol 2020 01 26;40(1):279-287. Epub 2019 Nov 26.

From the Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland (K.J.D., V.L.C., K.A.S., B.E.S., D.D.V., F.R., J.R.G., C. Templin).

Objective: Takotsubo syndrome (TTS) is characterized by acute left ventricular dysfunction, which can contribute to intraventricular thrombus and embolism. Still, prevalence and clinical impact of thrombus formation and embolic events on outcome of TTS patients remain unclear. This study aimed to investigate clinical features and outcomes of patients with and without intraventricular thrombus or embolism. Additionally, factors associated with thrombus formation or embolism, as well as predictors for mortality, were identified. Approach and Results: TTS patients enrolled in the International Takotsubo Registry at 28 centers in Australia, Europe, and the United States were dichotomized according to the occurrence/absence of intraventricular thrombus or embolism. Patients with intraventricular thrombus or embolism were defined as the ThrombEmb group. Of 1676 TTS patients, 56 (3.3%) patients developed intraventricular thrombus and/or embolism following TTS diagnosis (median time interval, 2.0 days [range, 0-38 days]). Patients in the ThrombEmb group had a different clinical profile including lower left ventricular ejection fraction, higher prevalence of the apical type, elevated levels of troponin and inflammatory markers, and higher prevalence of vascular disease. In a Firth bias-reduced penalized-likelihood logistic regression model apical type, left ventricular ejection fraction ≤30%, previous vascular disease, and a white blood cell count on admission >10×10 cells/μL emerged as independent predictors for thrombus formation or embolism.

Conclusions: Intraventricular thrombus or embolism occur in 3.3% of patients in the acute phase of TTS. A simple risk score including clinical parameters associated with intraventricular thrombus formation or embolism identifies patients at increased risk.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01947621.
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http://dx.doi.org/10.1161/ATVBAHA.119.313491DOI Listing
January 2020

Five-Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents.

J Am Heart Assoc 2019 11 7;8(22):e013607. Epub 2019 Nov 7.

Department of Cardiology Bern University Hospital Bern Switzerland.

Background The choice of optimal drug-eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long-term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus-eluting stents (BP-SES) versus durable polymer everolimus-eluting stents (DP-EES) in patients with DM. Methods and Results In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization) trial (NCT01443104), patients randomly assigned to ultrathin-strut BP-SES or thin-strut DP-EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM. Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (risk ratio, 1.23; 95% CI, 0.87-1.73 [=0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (risk ratio, 0.98; 95% CI, 0.77-1.26 [=0.90; for interaction=0.31]). Cumulative 5-year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP-SES or DP-EES. There was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusions In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin-strut BP-SES or thin-strut DP-EES. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01443104.
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http://dx.doi.org/10.1161/JAHA.119.013607DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6915288PMC
November 2019

Clinical Predictors and Prognostic Impact of Recovery of Wall Motion Abnormalities in Takotsubo Syndrome: Results From the International Takotsubo Registry.

J Am Heart Assoc 2019 11 1;8(21):e011194. Epub 2019 Nov 1.

University Heart Center Department of Cardiology University Hospital Zurich Zurich Switzerland.

Background Left ventricular (LV) recovery in takotsubo syndrome (TTS) occurs over a wide-ranging interval, varying from hours to weeks. We sought to investigate the clinical predictors and prognostic impact of recovery time for TTS patients. Methods and Results TTS patients from the International Takotsubo Registry were included in this study. Cut-off for early LV recovery was determined to be 10 days after the acute event. Multivariable logistic regression was used to assess factors associated with the absence of early recovery. In-hospital outcomes and 1-year mortality were compared for patients with versus without early recovery. We analyzed 406 patients with comprehensive and serial imaging data regarding time to recovery. Of these, 191 (47.0%) had early LV recovery and 215 (53.0%) demonstrated late LV improvement. Patients without early recovery were more often male (12.6% versus 5.2%; =0.011) and presented more frequently with typical TTS (76.3% versus 67.0%, =0.040). Cardiac and inflammatory markers were higher in patients without early recovery than in those with early recovery. Patients without early recovery showed unfavorable 1-year outcome compared with patients with early recovery (=0.003). On multiple logistic regression, male sex, LV ejection fraction <45%, and acute neurologic disorders were associated with the absence of early recovery. Conclusions TTS patients without early LV recovery have different clinical characteristics and less favorable 1-year outcome compared with patients with early recovery. The factors associated with the absence of early recovery included male sex, reduced LV ejection fraction, and acute neurologic events. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01947621.
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http://dx.doi.org/10.1161/JAHA.118.011194DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6898832PMC
November 2019

Do ultrathin strut bare-metal stents with passive coating improve efficacy in large coronary arteries? Insights from the randomized, multicenter BASKET-PROVE trials.

BMC Cardiovasc Disord 2019 10 16;19(1):226. Epub 2019 Oct 16.

Department of Cardiology, University Hospital Bispebjerg and Frederiksberg, DK-2400, Copenhagen, NV, Denmark.

Background: The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest higher rates of symptomatic restenosis in patients receiving the newer generation BMS. We investigated the efficacy of a newer generation ultrathin strut silicon-carbide coated cobalt-chromium (CoCr) BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0 mm).

Methods: All patients randomized to SCC- (n = 761) or UC-BMS (n = 765) in the two BASKET-PROVE trials were included. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis (ST) were also assessed. We used inverse probability weighted proportional hazards Cox regressions adjusting for known confounders.

Results: Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. The risk for clinically driven TVR was increased om the SCC-BMS group compared to the UC-BMS group (cumulative incidence, 10.6% vs. 8.4%; adjusted relative hazard [HR], 1.49 [95% CI, 1.05-2.10]). No differences in safety endpoints were detected, cardiac death (1.6% vs. 2.8%; HR, 0.62 [CI, 0.30-1.27]), non-fatal MI (3.2% vs. 2.5%; HR, 1.56 [CI, 0.83-2.91]), and definite/probable ST (0.8% vs. 1.1%; HR, 1.17 [CI, 0.39-3.50]). Differences in strut thickness between the two stents did not explain the association between stent type and clinically driven TVR.

Conclusions: In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of clinically driven repeat revascularization compared to the UC-BMS with no signs of an offsetting safety benefit.
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http://dx.doi.org/10.1186/s12872-019-1199-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6796469PMC
October 2019

Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the BIOSCIENCE Randomized Trial.

Circ Cardiovasc Interv 2019 08 6;12(8):e008024. Epub 2019 Aug 6.

Department of Cardiology, Inselspital, University of Bern, Bern University Hospital, Switzerland (J.H., S.W., T.P.).

Background: Randomized trials evaluating the Orsiro biodegradable polymer sirolimus-eluting stent (BP-SES; 60 and 80 μm strut thickness for stent diameters ≤3 and >3 mm, respectively) did not stratify according to vessel size and failed to specify the impact of ultrathin-strut thickness on long-term clinical outcomes compared with durable polymer everolimus-eluting stents (DP-EES). We sought to assess the long-term effect of ultrathin-strut (60 μm) BP-SES versus thin-strut (81 μm) DP-EES on long-term outcomes in patients undergoing percutaneous coronary revascularization for small vessel disease.

Methods: In a subgroup analysis of the randomized, multicenter, noninferiority BIOSCIENCE trial, patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with BP-SES or DP-EES were stratified according to vessel size (≤3 mm versus >3 mm) as a surrogate to compare patients treated with ultrathin-strut versus thin-strut drug-eluting stent. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years.

Results: Among 2109 patients, 1234 (59%) were treated for small vessel disease. At 5 years, target lesion failure occurred in 124 patients (cumulative incidence, 22.3%) treated with ultrathin-strut BP-SES and 109 patients (18.3%) treated with thin-strut DP-EES (rate ratio, 1.22; 95% CI, 0.94-1.58; =0.13). Cumulative incidences of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization and definite stent thrombosis at 5 years were similar in patients treated with ultrathin-strut BP-SES and thin-strut DP-EES. After adjustment for potential confounders, there was no significant interaction between vessel size and treatment effect of BP-SES versus DP-EES.

Conclusions: We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008024DOI Listing
August 2019

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial.

Lancet 2019 10 2;394(10205):1243-1253. Epub 2019 Sep 2.

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

Background: Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with biodegradable polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.

Methods: The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bülach, Switzerland) consisted of an ultrathin strut cobalt-chromium metallic stent platform releasing sirolimus from a biodegradable polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt-chromium stent platform that releases everolimus from a durable polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov, number NCT02579031.

Findings: Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with biodegradable polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with biodegradable polymer sirolimus-eluting stents and 626 (96%) patients treated with durable polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with biodegradable polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable polymer everolimus-eluting stents (difference -1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37-0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up.

Interpretation: In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents.

Funding: Biotronik.
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http://dx.doi.org/10.1016/S0140-6736(19)31877-XDOI Listing
October 2019

Prediction of short- and long-term mortality in takotsubo syndrome: the InterTAK Prognostic Score.

Authors:
Manfred B Wischnewsky Alessandro Candreva Beatrice Bacchi Victoria L Cammann Ken Kato Konrad A Szawan Sebastiano Gili Fabrizio D'Ascenzo Wolfgang Dichtl Rodolfo Citro Eduardo Bossone Michael Neuhaus Jennifer Franke Ioana Sorici-Barb Milosz Jaguszewski Michel Noutsias Maike Knorr Susanne Heiner Christof Burgdorf Behrouz Kherad Carsten Tschöpe Annahita Sarcon Jerold Shinbane Lawrence Rajan Guido Michels Roman Pfister Alessandro Cuneo Claudius Jacobshagen Mahir Karakas Wolfgang Koenig Alexander Pott Philippe Meyer Jose David Arroja Adrian Banning Florim Cuculi Richard Kobza Thomas A Fischer Tuija Vasankari K E Juhani Airaksinen L Christian Napp Monika Budnik Rafal Dworakowski Philip MacCarthy Christoph Kaiser Stefan Osswald Leonarda Galiuto Christina Chan Paul Bridgman Daniel Beug Clément Delmas Olivier Lairez Ibrahim El-Battrawy Ibrahim Akin Ekaterina Gilyarova Alexandra Shilova Mikhail Gilyarov Martin Kozel Petr Tousek David E Winchester Jan Galuszka Christian Ukena Gregor Poglajen Pedro Carrilho-Ferreira Christian Hauck Carla Paolini Claudio Bilato Abhiram Prasad Charanjit S Rihal Kan Liu P Christian Schulze Matteo Bianco Lucas Jörg Hans Rickli Thanh H Nguyen Yoshio Kobayashi Michael Böhm Lars S Maier Fausto J Pinto Petr Widimský Martin Borggrefe Stephan B Felix Grzegorz Opolski Ruediger C Braun-Dullaeus Wolfgang Rottbauer Gerd Hasenfuß Burkert M Pieske Heribert Schunkert Holger Thiele Johann Bauersachs Hugo A Katus John Horowitz Carlo Di Mario Thomas Münzel Filippo Crea Jeroen J Bax Thomas F Lüscher Frank Ruschitzka Jelena R Ghadri Christian Templin

Eur J Heart Fail 2019 11 27;21(11):1469-1472. Epub 2019 Aug 27.

Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.

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http://dx.doi.org/10.1002/ejhf.1561DOI Listing
November 2019

Clinical Features and Outcomes of Patients With Malignancy and Takotsubo Syndrome: Observations From the International Takotsubo Registry.

J Am Heart Assoc 2019 08 17;8(15):e010881. Epub 2019 Jul 17.

University Heart Center Department of Cardiology University Hospital Zurich Zurich Switzerland.

Background Clinical characteristics and outcomes of takotsubo syndrome (TTS) patients with malignancy have not been fully elucidated. This study sought to explore differences in clinical characteristics and to investigate short- and long-term outcomes in TTS patients with or without malignancy. Methods and Results TTS patients were enrolled from the International Takotsubo Registry. The TTS cohort was divided into patients with and without malignancy to investigate differences in clinical characteristics and to assess short- and long-term mortality. A subanalysis was performed comparing long-term mortality between a subset of TTS patients with or without malignancy and acute coronary syndrome (ACS) patients with or without malignancy. Malignancy was observed in 16.6% of 1604 TTS patients. Patients with malignancy were older and more likely to have physical triggers, but less likely to have emotional triggers compared with those without malignancy. Long-term mortality was higher in patients with malignancy (P<0.001), while short-term outcome was comparable (P=0.17). In a subanalysis, long-term mortality was comparable between TTS patients with malignancies and ACS patients with malignancies (P=0.13). Malignancy emerged as an independent predictor of long-term mortality. Conclusions A substantial number of TTS patients show an association with malignancy. History of malignancy might increase the risk for TTS, and therefore, appropriate screening for malignancy should be considered in these patients. Clinical Trial Registration URL: http://www.clinicaltrial.gov. Unique identifier: NCT01947621.
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http://dx.doi.org/10.1161/JAHA.118.010881DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6761645PMC
August 2019

Biodegradable polymer drug-eluting stent vs. contemporary durable polymer drug-eluting stents in patients with diabetes: a meta-analysis of randomized controlled trials.

Eur Heart J Qual Care Clin Outcomes 2020 01;6(1):81-88

Lifespan Cardiovascular Institute, Rhode Island Hospital, Providence, RI, USA.

Aims: The biodegradable polymer drug-eluting stents (BP-DES) offer controlled drug elution and complete degradation of the polymer over time, eventually lowering the risk for chronic inflammation and neoatherosclerosis, which can be particularly helpful in patients with diabetes. While BP-DES and durable polymer drug-eluting stents (DP-DES) have demonstrated comparable efficacy in all-comers population, their efficacy and safety in patients with diabetes remains uncertain.

Methods And Results: Electronic databases were systematically searched for randomized controlled trials (RCTs) comparing BP-DES with contemporary DP-DES in patients with diabetes. Study investigators were contacted to obtain additional data. The primary outcome was efficacy in terms of target-vessel revascularization (TVR) and target-lesion revascularization (TLR). We also evaluated the following safety outcomes separately: all-cause mortality, cardiac mortality, myocardial infarction (MI), and definite or probable stent thrombosis. Eleven RCTs including 5190 diabetic patients were included. At the longest available follow-up (mean 2.7 years), there was no significant difference in TLR [relative risk (RR): 1.02, 95% confidence interval (CI): 0.85-1.24; P = 0.80] or TVR (RR: 1.04, 95% CI: 0.81-1.34; P = 0.76). Safety outcomes of all-cause mortality, cardiac mortality, and MI were similar between the two groups. Stent thrombosis rates were also similar between BP-DES and DP-DES groups (1.66% vs. 1.83%; RR: 0.84, 95% CI: 0.54-1.31; P = 0.45). The heterogeneity was low and fixed-effect model yielded similar results. Meta-regression analysis showed no relationship between insulin requiring diabetes and difference in TLR or stent thrombosis between BP-DES and DP-DES.

Conclusion: Overall, BP-DESs have similar safety and efficacy profiles compared to contemporary DP-DES in patients with diabetes.
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http://dx.doi.org/10.1093/ehjqcco/qcz031DOI Listing
January 2020

Drug-eluting stents in large coronary vessels improve both safety and efficacy compared with bare-metal stents in women: a pooled analysis of the BASKET-PROVE I and II trials.

Open Heart 2019;6(1):e000986. Epub 2019 May 14.

Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.

Background: Drug-eluting stents (DES) have proven superior to bare-metal stents (BMS) in terms of safety and efficacy. However, inference to the female subgroup has been limited by low enrolment rates of women in clinical trials. The objective of this study was to investigate the safety and efficacy of DES versus BMS in women and men.

Methods: In a pooled analysis of two all-comers randomised trials (Basel Stent Kosten-Effektivitäts Trial-Prospective Validation Examination (BASKET-PROVE) and BASKET-PROVE II) (n=4605), we examined safety and efficacy of DES versus BMS according to sex. Patients were followed 2 years for a composite endpoint of cardiac death, non-fatal myocardial infarction (MI) and clinically driven target-vessel revascularisation not related to MI.

Results: Among the 1076 women and 3529 men included in the analysis, 65.6% of the women and 67.2% of the men were randomised to receive DES. At baseline, men had more complex coronary artery disease than women. After 2 years, DES reduced rates of major adverse cardiac events (MACE) compared with BMS in both women (cumulative incidence, 6.1% vs 14.7%; adjusted HR 0.36 (95% CI 0.24 to 0.54)) and men (7.7 vs 12.1%, HR 0.62 (0.50 to 0.77)), although the reduction in MACE rates was more pronounced in women (adjusted p=0.02 for sex-stent interaction). Event rates were lower in DES for both safety and efficacy outcomes, with the largest effect seen for non-MI TVR, in both women (2.3 vs 9.2%, adjusted HR 0.24 (0.13 to 0.44)) and men (4.0 vs 7.8%, adjusted HR 0.48 (0.36 to 0.64)) (adjusted p=0.049 for sex-stent interaction).

Conclusions: In patients requiring stenting of large coronary arteries, DES were associated with improved safety in women and superior efficacy in both sexes as compared with BMS.
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http://dx.doi.org/10.1136/openhrt-2018-000986DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6546185PMC
February 2021

Onchocerciasis-associated epilepsy: another piece in the puzzle from the Mahenge mountains, southern Tanzania.

Infect Dis Poverty 2019 05 24;8(1):35. Epub 2019 May 24.

Global Health Institute, University of Antwerp, Antwerp, Belgium.

In a study from the onchocerciasis-endemic area of Mahenge in southern Tanzania, Mmbando et al. [Inf Dis Poverty. 2018;7:64] demonstrate that in four selected villages the overall epilepsy prevalence was high, and significantly more elevated in the two villages of higher onchocerciasis endemicity compared to those of lower endemicity. This is replicating earlier findings from many other areas of tropical Africa. The authors are also providing data indicating that in the Mahenge focus, the prevalence of nodding syndrome may be related to that of onchocerciasis in the same way as epilepsy in general. The application of a clinical case definition for onchocerciasis-associated epilepsy (OAE) as used in the study of Mmbando et al. [Inf Dis Poverty. 2018;7:64] faces some difficulties; indeed, its precision in discerning cases of OAE from epilepsy due to other etiologies is not known, and it does not allow for a specific diagnosis in the individual patient. Because an operational surveillance tool for assessing the number of patients in the population could mean substantial advance for better estimating the burden of OAE, the proposed definition should be tried in different settings and its performance reviewed in the process.
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http://dx.doi.org/10.1186/s40249-019-0545-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6533739PMC
May 2019