Journal: Clin Res Cardiol

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Abstract

Impact of effective regurgitant orifice area on outcome of secondary mitral regurgitation transcatheter repair.

Karam N, Orban M, Kalbacher D, Butter C, ... Hausleiter J, EuroSMR investigators
Objectives
To assess the value of effective regurgitant orifice (ERO) in predicting outcome after edge-to-edge transcatheter mitral valve repair (TMVR) for secondary mitral regurgitation (SMR) and identify the optimal cut-off for patients\' selection.
Methods
Using the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry, that included patients undergoing edge-to-edge TMVR for SMR between November 2008 and January 2019 in 8 experienced European centres, we assessed the optimal ERO threshold associated with mortality in SMR patients undergoing TMVR, and compared characteristics and outcomes of patients according to baseline ERO.
Results
Among 1062 patients with severe SMR and ERO quantification by proximal isovelocity surface area method in the registry, ERO was < 0.3 cm2 in 575 patients (54.1%), who were more symptomatic at baseline (NYHA class ≥ III: 91.4% vs. 86.9%, for ERO < vs. ≥ 0.3 cm2; P = 0.004). There was no difference in all-cause mortality at 2-year follow-up according to baseline ERO (28.3% vs. 30.0% for ERO < vs. ≥ 0.3 cm2, P = 0.585). Both patient groups demonstrated significant improvement of at least one NYHA class (61.7% and 73.8%, P = 0.002), resulting in a prevalence of NYHA class ≤ II at 1-year follow-up of 60.0% and 67.4% for ERO < vs. ≥ 0.3 cm2, respectively (P = 0.05).
Conclusion
All-cause mortality at 2 years after TMVR does not differ if baseline ERO is < or ≥ 0.3 cm2, and both groups exhibit relevant clinical improvements. Accordingly, TMVR should not be withheld from patients with ERO < 0.3 cm2 who remain symptomatic despite optimal medical treatment, if TMVR appropriateness was determined by experienced teams in dedicated valve centres.



Clin Res Cardiol: 03 Mar 2021; epub ahead of print
Karam N, Orban M, Kalbacher D, Butter C, ... Hausleiter J, EuroSMR investigators
Clin Res Cardiol: 03 Mar 2021; epub ahead of print | PMID: 33661372
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Abstract

Imaging strategies for safety surveillance after renal artery denervation.

Cohen DL, Weinberg I, Uretsky S, Popma JJ, ... Cohen SA, Townsend RR
Renal denervation has emerged as a safe and effective therapy to lower blood pressure in hypertensive patients. In addition to the main renal arteries, branch vessels are also denervated in more contemporary studies. Accurate and reliable imaging in renal denervation patients is critical for long-term safety surveillance due to the small risk of renal artery stenosis that may occur after the procedure. This review summarizes three common non-invasive imaging modalities: Doppler ultrasound (DUS), computed tomography angiography (CTA), and magnetic resonance angiography (MRA). DUS is the most widely used owing to cost considerations, ease of use, and the fact that it is less invasive, avoids ionizing radiation exposure, and requires no contrast media use. Renal angiography is used to determine if renal artery stenosis is present when non-invasive imaging suggests renal artery stenosis. We compiled data from prior renal denervation studies as well as the more recent SPYRAL-HTN OFF MED Study and show that DUS demonstrates both high sensitivity and specificity for detecting renal stenosis de novo and in longitudinal assessment of renal artery patency after interventions. In the context of clinical trials DUS has been shown, together with the use of the baseline angiogram, to be effective in identifying stenosis in branch and accessory arteries and merits consideration as the main screening imaging modality to detect clinically significant renal artery stenosis after renal denervation and this is consistent with guidelines from the recent European Consensus Statement on Renal Denervation.



Clin Res Cardiol: 28 Feb 2021; epub ahead of print
Cohen DL, Weinberg I, Uretsky S, Popma JJ, ... Cohen SA, Townsend RR
Clin Res Cardiol: 28 Feb 2021; epub ahead of print | PMID: 33646357
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Abstract

Heart failure and atrial fibrillation in patients with an interatrial shunt.

Park JJ, Cho GY, Choi W, Hwang IC, ... Han MK, Bae HJ
Objective
Congenital interatrial shunt can unload the left atrium (LA) and may lower the risk of new-onset heart failure (HF) or atrial fibrillation (AF). We evaluated the risk of new-onset HF or AF in patients with and without interatrial shunt.
Methods
We enrolled 2660 consecutive patients with acute stroke or transient ischemic attack (TIA) who underwent transesophageal echocardiography at Seoul National University Bundang Hospital from January 1, 2006 to December 31, 2018. The primary outcomes were 10-year new-onset HF, new-onset AF, and new-onset HF or AF composite.
Results
Overall, 466 (17.5%) patients with an interatrial shunt had smaller E velocity (0.66 ± 0.21 vs. 0.69 ± 0.22 m/s, P = 0.037) and smaller E/e\' (9.1 ± 4.0 vs. 10.0 ± 5.0, P = 0.001) than 2194 (82.5%) patients without an interatrial shunt. The 10-year incidence of AF, HF, and AF or HF composite was lower in patients with an interatrial shunt (10-year AF, 11.2 vs. 17.8%, P < 0.001; 10-year HF, 6.2 vs. 10.4%, P = 0.005; 10-year AF or HF composite, 16.5 vs. 23.4%, P = 0.001). In multivariable analysis, the presence of an interatrial shunt was associated with a 38% (HR 0.62, 95% CI 0.40-0.96), 40% (HR 0.60; 95% CI 0.39-0.93), and 26% (HR 0.74; 95% CI 0.57-0.96) reduced risk for new-onset HF, AF, and new-onset HF or AF composite, respectively.
Conclusion
In patients with interatrial shunt, the risk of AF and HF was lower. Interatrial shunt may be beneficial, and the closure of an interatrial shunt should be performed only in carefully selected patients. An interatrial shunt can unload the left atrium. In patients with stroke or TIA, the presence of an interatrial shunt was associated with a reduced risk for new-onset HF and AF. AF atrial fibrillation, HF heart failure, HR hazard ratio, LA left atrium.



Clin Res Cardiol: 28 Feb 2021; epub ahead of print
Park JJ, Cho GY, Choi W, Hwang IC, ... Han MK, Bae HJ
Clin Res Cardiol: 28 Feb 2021; epub ahead of print | PMID: 33649885
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Abstract

Bacterial biofilms in infective endocarditis: an in vitro model to investigate emerging technologies of antimicrobial cardiovascular device coatings.

Lauten A, Martinović M, Kursawe L, Kikhney J, ... Falk V, Moter A
Objective
In spite of the progress in antimicrobial and surgical therapy, infective endocarditis (IE) is still associated with a high morbidity and mortality. IE is characterized by bacterial biofilms of the endocardium, especially of the aortic and mitral valve leading to their destruction. About one quarter of patients with formal surgery indication cannot undergo surgery. This group of patients needs further options of therapy, but due to a lack of models for IE prospects of research are low. Therefore, the purpose of this project was to establish an in vitro model of infective endocarditis to allow growth of bacterial biofilms on porcine aortic valves, serving as baseline for further research.
Methods and results
A pulsatile two-chamber circulation model was constructed that kept native porcine aortic valves under sterile, physiologic hemodynamic and temperature conditions. To create biofilms on porcine aortic valves the system was inoculated with Staphylococcus epidermidis PIA 8400. Aortic roots were incubated in the model for increasing periods of time (24 h and 40 h) and bacterial titration (1.5 × 104 CFU/mL and 1.5 × 105 CFU/mL) with 5 L cardiac output per minute. After incubation, tissue sections were analysed by fluorescence in situ hybridization (FISH) for direct visualization of the biofilms. Pilot tests for biofilm growth showed monospecies colonization consisting of cocci with time- and inocula-dependent increase after 24 h and 40 h (n = 4). In n = 3 experiments for 24 h, with the same inocula, FISH visualized biofilms with ribosome-containing, and thus metabolic active cocci, tissue infiltration and similar colonization pattern as observed by the FISH in human IE heart valves infected by S. epidermidis.
Conclusion
These results demonstrate the establishment of a novel in vitro model for bacterial biofilm growth on porcine aortic roots mimicking IE. The model will allow to identify predilection sites of valves for bacterial adhesion and biofilm growth and it may serve as baseline for further research on IE therapy and prevention, e.g. the development of antimicrobial transcatheter approaches to IE.



Clin Res Cardiol: 27 Feb 2021; 110:323-331
Lauten A, Martinović M, Kursawe L, Kikhney J, ... Falk V, Moter A
Clin Res Cardiol: 27 Feb 2021; 110:323-331 | PMID: 32444905
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Abstract

The diagnostic benefit of 16S rDNA PCR examination of infective endocarditis heart valves: a cohort study of 146 surgical cases confirmed by histopathology.

Armstrong C, Kuhn TC, Dufner M, Ehlermann P, ... Leuschner F, Heininger A
Aims
Upon suspicion of infective endocarditis, the causative microorganism must be identified to optimize treatment. Blood cultures and culturing of removed valves are the mainstay of this diagnosis and should be complemented by growth-independent methods. We assessed the diagnostic benefit of examining removed endocarditis valves by broad-range bacterial PCR to detect causative bacteria in cases where culturing was not available, negative, or inconclusive because a skin commensal was detected, in patients from our clinical routine practice.
Methods and results
Patients from Heidelberg University Hospital with suspicion of endocarditis, followed by valve replacement and analysis by 16S rDNA PCR, between 2015 and 2018, were evaluated. 146 patients with definite infective endocarditis, confirmed by the valve macroscopics and/or histology, were included. Valve PCRs were compared to corresponding blood and valve culture results. Overall, valve PCR yielded an additional diagnostic benefit in 34 of 146 cases (23%) and was found to be more sensitive than valve culture. In 19 of 38 patients with both negative blood and valve cultures, valve PCR was the only method rendering a pathogen. In 23 patients with positive blood cultures detecting skin commensals, 4 patients showed discordant valve PCR results, detecting a more plausible pathogen, and in 11 of 23 cases, valve PCR confirmed commensals in blood culture as true pathogens. Only the remaining 8 patients had negative valve PCRs.
Conclusion
Valve PCR was found to be a valuable diagnostic tool in surgical endocarditis cases with negative blood cultures or positive blood cultures of unknown significance.
Trial registration
S-440/2017 on 28.08.2017 retrospectively registered. Subdividing of all infective endocarditis patients in this study, showing that valve PCR yields valuable information for patients with skin commensals in blood cultures, which were either confirmed by the same detection in valve PCR or refuted by the detection of a different and typical pathogen in valve PCR. Additionally, benefit was determined in patients with negative or not available blood cultures and only positive detection in valve PCR. +: Positive; -: negative; n/a: not available results.



Clin Res Cardiol: 27 Feb 2021; 110:332-342
Armstrong C, Kuhn TC, Dufner M, Ehlermann P, ... Leuschner F, Heininger A
Clin Res Cardiol: 27 Feb 2021; 110:332-342 | PMID: 32488586
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Impact:
Abstract

Machine learning-based risk prediction of intrahospital clinical outcomes in patients undergoing TAVI.

Gomes B, Pilz M, Reich C, Leuschner F, ... Katus HA, Meder B
Background
Currently, patient selection in TAVI is based upon a multidisciplinary heart team assessment of patient comorbidities and surgical risk stratification. In an era of increasing need for precision medicine and quickly expanding TAVI indications, machine learning has shown promise in making accurate predictions of clinical outcomes. This study aims to predict different intrahospital clinical outcomes in patients undergoing TAVI using a machine learning-based approach. The main clinical outcomes include all-cause mortality, stroke, major vascular complications, paravalvular leakage, and new pacemaker implantations.
Methods and results
The dataset consists of 451 consecutive patients undergoing elective TAVI between February 2014 and June 2016. The applied machine learning methods were neural networks, support vector machines, and random forests. Their performance was evaluated using five-fold nested cross-validation. Considering all 83 features, the performance of all machine learning models in predicting all-cause intrahospital mortality (AUC 0.94-0.97) was significantly higher than both the STS risk score (AUC 0.64), the STS/ACC TAVR score (AUC 0.65), and all machine learning models using baseline characteristics only (AUC 0.72-0.82). Using an extreme boosting gradient, baseline troponin T was found to be the most important feature among all input variables. Overall, after feature selection, there was a slightly inferior performance. Stroke, major vascular complications, paravalvular leakage, and new pacemaker implantations could not be accurately predicted.
Conclusions
Machine learning has the potential to improve patient selection and risk management of interventional cardiovascular procedures, as it is capable of making superior predictions compared to current logistic risk scores.



Clin Res Cardiol: 27 Feb 2021; 110:343-356
Gomes B, Pilz M, Reich C, Leuschner F, ... Katus HA, Meder B
Clin Res Cardiol: 27 Feb 2021; 110:343-356 | PMID: 32583062
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Abstract

Risk modeling in transcatheter aortic valve replacement remains unsolved: an external validation study in 2946 German patients.

Wolff G, Shamekhi J, Al-Kassou B, Tabata N, ... Kelm M, Veulemans V
Background
Surgical risk prediction models are routinely used to guide decision-making for transcatheter aortic valve replacement (TAVR). New and updated TAVR-specific models have been developed to improve risk stratification; however, the best option remains unknown.
Objective
To perform a comparative validation study of six risk models for the prediction of 30-day mortality in TAVR METHODS AND
Results:
A total of 2946 patients undergoing transfemoral (TF, n = 2625) or transapical (TA, n = 321) TAVR from 2008 to 2018 from the German Rhine Transregio Aortic Diseases cohort were included. Six surgical and TAVR-specific risk scoring models (LogES I, ES II, STS PROM, FRANCE-2, OBSERVANT, GAVS-II) were evaluated for the prediction of 30-day mortality. Observed 30-day mortality was 3.7% (TF 3.2%; TA 7.5%), mean 30-day mortality risk prediction varied from 5.8 ± 5.0% (OBSERVANT) to 23.4 ± 15.9% (LogES I). Discrimination performance (ROC analysis, c-indices) ranged from 0.60 (OBSERVANT) to 0.67 (STS PROM), without significant differences between models, between TF or TA approach or over time. STS PROM discriminated numerically best in TF TAVR (c-index 0.66; range of c-indices 0.60 to 0.66); performance was very similar in TA TAVR (LogES I, ES II, FRANCE-2 and GAVS-II all with c-index 0.67). Regarding calibration, all risk scoring models-especially LogES I-overestimated mortality risk, especially in high-risk patients.
Conclusions
Surgical as well as TAVR-specific risk scoring models showed mediocre performance in prediction of 30-day mortality risk for TAVR in the German Rhine Transregio Aortic Diseases cohort. Development of new or updated risk models is necessary to improve risk stratification.



Clin Res Cardiol: 27 Feb 2021; 110:368-376
Wolff G, Shamekhi J, Al-Kassou B, Tabata N, ... Kelm M, Veulemans V
Clin Res Cardiol: 27 Feb 2021; 110:368-376 | PMID: 32851491
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Impact:
Abstract

Kidney injury as post-interventional complication of TAVI.

Morcos M, Burgdorf C, Vukadinivikj A, Mahfoud F, ... Schwenger V, Remppis A
Transcatheter aortic valve implantation (TAVI) is an accepted treatment approach of aortic stenosis. In the beginning, this technique was executed in high-risk patients only. Today, intermediate-risk patients are also amenable for TAVI, as long as the transfemoral approach is chosen. Numerous predictors have been identified that could lead to periprocedural complications and are defined by patient co-morbidities as well as being inherent to the technical approach. Although vascular complications and postinterventional paravalvular regurgitation have been minimized over the past years by revised technologies and techniques, there is a prevailing individual risk brought about by the specific pathophysiology of the cardiorenal syndrome.



Clin Res Cardiol: 27 Feb 2021; 110:313-322
Morcos M, Burgdorf C, Vukadinivikj A, Mahfoud F, ... Schwenger V, Remppis A
Clin Res Cardiol: 27 Feb 2021; 110:313-322 | PMID: 32844282
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Abstract

A safe and simple technique for crossing stenotic aortic valves.

Schoels W, Mahmoud MS, Kullmer M, Dia M
Objectives
To describe and to validate a new technique for crossing stenotic aortic valves (AV).
Background
Current techniques for crossing the AV may be time-consuming and hazardous.
Methods
One hundred consecutive patients with severe aortic stenosis treated by transfemoral TAVI were prospectively selected to have an initial attempt of 5 min to cross the AV with a novel pigtail/J-wire technique before switching to the conventional Amplatz®/straight wire approach. For the pigtail/J-wire technique, the catheter is placed 3-4 cm above the AV and turned anteriorly in the 30° RAO view. A J-wire pushed out of the pigtail-catheter will reach the anterior wall of the ascending aorta, forming a u-shaped curve above the AV. The height of the pigtail catheter determines the width of the curve, rotation will help to find an orientation, where the vertex of the curved J-wire easily passes the AV. We analyzed the primary success rate within 5 min and the mean crossing time required.
Results
Patients were 83.5 ± 5.5 years of age and predominantly male (62%). Primary success rate was 86%, AV crossing took 48.2 ± 34.6 s without complications. Fourteen failed cases were successfully managed with AL1- (6) and both, AL1- and AL2-catheters (8), respectively
Conclusions:
The pigtail/J-wire technique for AV crossing is safe, simple and fast. Primary placement of a pigtail catheter into the left ventricle at a success rate of 86% facilitates TAVI procedures.



Clin Res Cardiol: 27 Feb 2021; 110:377-381
Schoels W, Mahmoud MS, Kullmer M, Dia M
Clin Res Cardiol: 27 Feb 2021; 110:377-381 | PMID: 32949287
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Abstract

Transcatheter or surgical aortic valve implantation in chronic dialysis patients: a German Aortic Valve Registry analysis.

Färber G, Bleiziffer S, Doenst T, Bon D, ... Fichtlscherer S, GARY Executive Board
Objectives
The aim of this study was to compare outcomes of transcatheter and surgical aortic valve implantation in chronic dialysis patients with aortic valve stenosis (AS).
Background
Chronic dialysis patients undergoing heart valve surgery are at higher risk for morbidity and mortality. Whether interventional techniques can reduce this risk is unclear because dialysis patients have thus far been excluded from randomized trials.
Methods
Chronic dialysis patients with AS enrolled in the German Aortic Valve Registry (GARY) between 2012 and 2015 were analyzed to compare transcatheter aortic valve implantation (TAVI n = 661) with surgical aortic valve replacement (SAVR n = 457). Propensity scores for inverse probability of treatment weighting (IPTW) were used to adjust the comparison of the two treatment groups for potential confounders.
Results
TAVI patients were older (78 ± 7.3 vs. 69 ± 10.2 years, p < 0.01, unadjusted) and had more comorbidities. Mortality at 1 year was the same (TAVI: 33.4% vs. SAVR 35.0%, p = 0.72, IPTW-adjusted) while it was lower with TAVI at 30 days (8.6% vs. 15.0%, p = 0.02, IPTW-adjusted). TAVI patients required more pacemaker implantation and showed more aortic regurgitation. SAVR patients required more blood transfusions and had longer hospital stay. Diabetes mellitus, atrial fibrillation, previous PCI, urgent procedure and EuroSCORE were associated with elevated 30-day mortality. Atrial fibrillation and older age were independent risk factor of 1-year mortality in both groups.
Conclusions
Chronic dialysis patients with AS undergoing TAVI or SAVR had the same 1-year mortality, although survival at 30 days was better with TAVI. These results suggest that TAVI may improve peri-procedural outcomes.



Clin Res Cardiol: 27 Feb 2021; 110:357-367
Färber G, Bleiziffer S, Doenst T, Bon D, ... Fichtlscherer S, GARY Executive Board
Clin Res Cardiol: 27 Feb 2021; 110:357-367 | PMID: 32965556
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Impact:
Abstract

Metabolomic profiling of patients with high gradient aortic stenosis undergoing transcatheter aortic valve replacement.

Haase D, Bäz L, Bekfani T, Neugebauer S, ... Franz M, Schulze PC
Aim
Aim of our study was to evaluate metabolic changes in patients with aortic stenosis (AS) before and after transcatheter aortic valve replacement (TAVR) and to assess whether this procedure reverses metabolomic alterations.
Methods
188 plasma metabolites of 30 patients with severe high-gradient aortic valve stenosis (pre-TAVR and 6 weeks post-TAVR) as well as 20 healthy controls (HC) were quantified by liquid chromatography tandem mass spectrometry. Significantly altered metabolites were then correlated to an extensive patient database of clinical parameters at the time of measurement.
Results
Out of the determined metabolites, 26.6% (n = 50) were significantly altered in patients with AS pre-TAVR compared to HC. In detail, 5/40 acylcarnitines as well as 10/42 amino acids and biogenic amines were mainly increased in AS, whereas 29/90 glycerophospholipids and 6/15 sphingomyelins were mainly reduced. In the post-TAVR group, 10.1% (n = 19) of metabolites showed significant differences when compared to pre-TAVR. Moreover, we found nine metabolites revealing reversible concentration levels. Correlation with clinically important parameters revealed strong correlations between sphingomyelins and cholesterol (r = 0.847), acylcarnitines and brain natriuretic peptide (r = 0.664) and showed correlation of acylcarnitine with an improvement of left ventricular (LV) ejection fraction (r = - 0.513) and phosphatidylcholines with an improvement of LV mass (r = - 0.637).
Conclusion
Metabolic profiling identified significant and reversible changes in circulating metabolites of patients with AS. The correlation of circulating metabolites with clinical parameters supports the use of these data to identify novel diagnostic as well as prognostic markers for disease screening, pathophysiological studies as well as patient surveillance.



Clin Res Cardiol: 27 Feb 2021; 110:399-410
Haase D, Bäz L, Bekfani T, Neugebauer S, ... Franz M, Schulze PC
Clin Res Cardiol: 27 Feb 2021; 110:399-410 | PMID: 33057764
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Impact:
Abstract

Risk of mortality following transcatheter aortic valve replacement for low-flow low-gradient aortic stenosis.

Wilde N, Sugiura A, Sedaghat A, Becher MU, ... Veulemans V, Tiyerili V
Background
Low-flow low-gradient (LF-LG) aortic stenosis (AS) is associated with high mortality, even after transcatheter aortic valve replacement (TAVR). Further knowledge of risk indicators is needed and a clinical risk score would be desirable for optimizing patient selection and therapeutic strategy.
Methods
The study cohort comprised of 219 consecutive LF-LG AS patients undergoing TAVR from 2008 to 2018 in two high-volume German centers. Predictive factors for one-year all-cause mortality were defined according to a Cox proportional hazard model.
Results
At one-year follow-up after TAVR, 28% of patients had died. A multivariate model revealed six independent predictors of one-year mortality: history of myocardial infarction (HR 2.05, 95%CI 1.13-3.72), eGFR < 30 ml/min/1.73m2 (HR 2.75, 95%CI 1.48-5.11), tricuspid regurgitation moderate or more (HR 2.06, 95%CI 1.14-3.72), stroke volume index < 25 mL/m2 (HR 2.03, 95%CI 1.14-3.62), self-expandable device (HR 2.72, 95%CI 1.17-6.27), and non-transfemoral approach (HR 3.42, 95%CI 1.28-9.14). The Rhineland Risk Score (RRS) consisting of these variables (c statistic 0.75, 95%CI 0.68-0.82, p < 0.001) was superior to the EuroSCORE II (c statistic 0.63) and STS-PROM score (c statistic 0.69) at predicting one-year mortality. Patients with a RRS ≥ 8 had a prohibitive risk of one-year mortality of 67.6% (95%CI 52.0-82.4%).
Conclusion
In patients with LF-LG AS, history of myocardial infarction, renal dysfunction, tricuspid regurgitation, a low stroke volume index, self-expandable device, and non-femoral approach were associated with increased 1-year mortality after TAVR. The RRS might serve as a helpful tool for risk prediction and patient selection for TAVR in patients with LF-LG AS.



Clin Res Cardiol: 27 Feb 2021; 110:391-398
Wilde N, Sugiura A, Sedaghat A, Becher MU, ... Veulemans V, Tiyerili V
Clin Res Cardiol: 27 Feb 2021; 110:391-398 | PMID: 33052475
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Impact:
Abstract

Early results of a real-world series with two transapical transcatheter mitral valve replacement devices.

Ludwig S, Kalbacher D, Schofer N, Schäfer A, ... Lubos E, Conradi L
Aims
Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices.
Methods and results
A total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.
Conclusions
TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.



Clin Res Cardiol: 27 Feb 2021; 110:411-420
Ludwig S, Kalbacher D, Schofer N, Schäfer A, ... Lubos E, Conradi L
Clin Res Cardiol: 27 Feb 2021; 110:411-420 | PMID: 33074368
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Impact:
Abstract

Elevated high-sensitivity troponin T levels at 1-year follow-up are associated with increased long-term mortality after TAVR.

Seoudy H, Lambers M, Winkler V, Dudlik L, ... Frey N, Frank D
Background
Elevated pre-procedural high-sensitivity troponin T (hs-TnT) levels predict adverse outcomes in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). It is unknown whether elevated troponin levels still provide prognostic information during follow-up after successful TAVR. We evaluated the long-term implications of elevated hs-TnT levels found at 1-year post-TAVR.
Methods and results
The study included 349 patients who underwent TAVR for severe AS from 2010-2019 and for whom 1-year hs-TnT levels were available. Any required percutaneous coronary interventions were performed > 1 week before TAVR. The primary endpoint was survival time starting at 1-year post-TAVR. Optimal hs-TnT cutoff for stratifying risk, identified by ROC analysis, was 39.4 pg/mL. 292 patients had hs-TnT < 39.4 pg/mL (median 18.3 pg/mL) and 57 had hs-TnT ≥ 39.4 pg/mL (median 51.2 pg/mL). The high hs-TnT group had a higher median N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, greater left ventricular (LV) mass, higher prevalence of severe diastolic dysfunction, LV ejection fraction < 35%, severe renal dysfunction, and more men compared with the low hs-TnT group. All-cause mortality during follow-up after TAVR was significantly higher among patients who had hs-TnT ≥ 39.4 pg/mL compared with those who did not (mortality rate at 2 years post-TAVR: 12.3% vs. 4.1%, p = 0.010). Multivariate analysis identified 1-year hs-TnT ≥ 39.4 pg/mL (hazard ratio 2.93, 95% CI 1.91-4.49, p < 0.001), NT-proBNP level > 300 pg/mL, male sex, an eGFR < 60 mL/min/1.73 m2 and chronic obstructive pulmonary disease as independent risk factors for long-term mortality after TAVR.
Conclusions
Elevated hs-TnT concentrations at 1-year after TAVR were associated with a higher long-term mortality.



Clin Res Cardiol: 27 Feb 2021; 110:421-428
Seoudy H, Lambers M, Winkler V, Dudlik L, ... Frey N, Frank D
Clin Res Cardiol: 27 Feb 2021; 110:421-428 | PMID: 33098469
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Impact:
Abstract

Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve.

Husso A, Airaksinen J, Juvonen T, Laine M, ... Valtola A, Biancari F
Objectives
To compare the outcomes after surgical (SAVR) and transcatheter aortic valve replacement (TAVR) for severe stenosis of bicuspid aortic valve (BAV).
Methods
We evaluated the early and mid-term outcome of patients with stenotic BAV who underwent SAVR or TAVR for aortic stenosis from the nationwide FinnValve registry.
Results
The FinnValve registry included 6463 AS patients and 1023 (15.8%) of them had BAV. SAVR was performed in 920 patients and TAVR in 103 patients with BAV. In the overall series, device success after TAVR was comparable to SAVR (94.2% vs. 97.1%, p = 0.115). TAVR was associated with increased rate of mild-to-severe paravalvular regurgitation (PVR) (19.4% vs. 7.9%, p < 0.0001) and of moderate-to-severe PVR (2.9% vs. 0.7%, p = 0.053). When newer-generation TAVR devices were evaluated, mild-to-severe PVR (11.9% vs. 7.9%, p = 0.223) and moderate-to-severe PVR (0% vs. 0.7%, p = 1.000) were comparable to SAVR. Type 1 N-L and type 2 L-R/R-N were the BAV morphologies with higher incidence of mild-to-severe PVR (37.5% and 100%, adjusted for new-generation prostheses p = 0.025) compared to other types of BAVs. Among 75 propensity score-matched cohorts, 30-day mortality was 1.3% after TAVR and 5.3% after SAVR (p = 0.375), and 2-year mortality was 9.7% after TAVR and 18.7% after SAVR (p = 0.268)
Conclusions:
In patients with stenotic BAV, TAVR seems to achieve early and mid-term results comparable to SAVR. Type 1 N-L and type 2 L-R/R-N BAV morphologies had higher incidence of PVR. Larger studies evaluating different phenotypes of BAV are needed to confirm these findings.
Clinical trial registration
ClinicalTrials.gov Identifier: NCT03385915.



Clin Res Cardiol: 27 Feb 2021; 110:429-439
Husso A, Airaksinen J, Juvonen T, Laine M, ... Valtola A, Biancari F
Clin Res Cardiol: 27 Feb 2021; 110:429-439 | PMID: 33099681
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Impact:
Abstract

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

Kozlik-Feldmann R, Lorber A, Sievert H, Ewert P, ... Galal O, Meinertz T
Objective
This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm.
Background
The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects.
Methods
In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD.
Results
The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2-65) years and a median body weight of 26.7 (10-109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients).
Conclusion
The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.



Clin Res Cardiol: 27 Feb 2021; 110:382-390
Kozlik-Feldmann R, Lorber A, Sievert H, Ewert P, ... Galal O, Meinertz T
Clin Res Cardiol: 27 Feb 2021; 110:382-390 | PMID: 33128576
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Impact:
Abstract

Impact of cancer history on clinical outcome in patients undergoing transcatheter edge-to-edge mitral repair.

Tabata N, Weber M, Sugiura A, Öztürk C, ... Nickenig G, Sinning JM
Background
Little is known about the prevalence of a history of cancer and its impact on clinical outcome in mitral regurgitation (MR) patients undergoing transcatheter mitral valve repair (TMVR).
Objectives
The purpose of this study is to investigate the prevalence of cancer, baseline inflammatory parameters, and clinical outcome in MR patients undergoing TMVR.
Methods
Consecutive patients undergoing a MitraClip procedure were enrolled, and the patients were stratified into two groups: cancer and non-cancer. Baseline complete blood counts (CBC) with differential hemograms were collected prior to the procedure to calculate the platelet-to-lymphocyte ratio (PLR) and neutrophil-to-lymphocyte ratio (NLR). All-cause death within a one-year was examined.
Results
In total, 82 out of 446 patients (18.4%) had a history of cancer. Cancer patients had a significantly higher baseline PLR [181.4 (121.1-263.9) vs. 155.4 (109.4-210.4); P = 0.012] and NLR [5.4 (3.5-8.3) vs. 4.0 (2.9-6.1); P = 0.002] than non-cancer patients. A Kaplan-Meier analysis revealed that cancer patients had a significantly worse prognosis than non-cancer (estimated 1-year mortality, 20.2 vs. 9.2%; log-rank P = 0.009), and multivariable analyses of three models showed that cancer history was an independent factor for 1-year mortality. Patients who died during follow-up had a significantly higher baseline PLR [214.2 (124.2-296.7) vs. 156.3 (110.2-212.1); P = 0.007] and NLR [6.4 (4.2-12.5) vs. 4.0 (2.9-6.2); P < 0.001] than survivors.
Conclusions
In MitraClip patients, a history of cancer was associated with higher inflammatory parameters and worse prognosis compared to non-cancer patients. Central Illustration. Clinical outcomes and baseline PLR and NLR values accord-ing to one-year mortality. (Left) Patients who died within the follow-up period had a significantly higher baseline PLR (214.2 [124.2-296.7] vs 156.3 [110.2-212.1]; P = 0.007) and NLR (6.4 [4.2-12.5] vs 4.0 [2.9-6.2]; P < 0.001) than patients who survived. PLR, platelet-to-lymphocyte ratio; NLR, neutrophil-to-lymphocyte ratio (Right) A Kaplan-Meier analysis revealed that cancer patients had a significantly worse prognosis than non-cancer patients (estimated one-year mortality, 20.2 vs 9.2%; log-rank P = 0.009).



Clin Res Cardiol: 27 Feb 2021; 110:440-450
Tabata N, Weber M, Sugiura A, Öztürk C, ... Nickenig G, Sinning JM
Clin Res Cardiol: 27 Feb 2021; 110:440-450 | PMID: 33169224
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Impact:
Abstract

PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis.

Sugiura A, Vogelhuber J, Öztürk C, Schwaibold Z, ... Nickenig G, Weber M
Background
Transcatheter tricuspid valve repair (TTVR) is a promising technique for the treatment of tricuspid regurgitation (TR). Data comparing the performance of novel edge-to-edge devices (PASCAL and MitraClip-XTR) are scarce.
Methods
We identified 80 consecutive patients who underwent TTVR using either the PASCAL or MitraClip-XTR system to treat symptomatic TR from July 2018 to June 2020. To adjust for baseline imbalances, we performed a propensity score (PS) 1:1 matching. The primary endpoint was a reduction in TR severity by at least one grade at 30 days.
Results
The PS-matched cohort (n = 44) was at high-surgical risk (EuroSCORE II: 7.5% [interquartile range (IQR) 4.8-12.1%]) with a mean TR grade of 4.3 ± 0.8 and median coaptation gap of 6.2 mm [IQR 3.2-9.1 mm]. The primary endpoint was similarly observed in both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p = 0.99). No periprocedural death or conversions to surgery occurred, and 30-day mortality (5.0% vs. 5.0%, log-rank p = 0.99) and 3-month mortality (10.0% vs. 5.0%, log-rank p = 0.56) were similar between both groups. During follow-up, functional NYHA class, 6-min walking distance, and health status improved in both groups.
Conclusions
Both TTVR devices, PASCAL and MitraClip-XTR, appeared feasible and comparable for an effective TR reduction. Randomized head-to-head comparisons will help to further define the appropriate scope of application of each system.



Clin Res Cardiol: 27 Feb 2021; 110:451-459
Sugiura A, Vogelhuber J, Öztürk C, Schwaibold Z, ... Nickenig G, Weber M
Clin Res Cardiol: 27 Feb 2021; 110:451-459 | PMID: 33313975
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Impact:
Abstract

Aortic valve replacement in Germany in 2019.

Gaede L, Blumenstein J, Husser O, Liebetrau C, ... Achenbach S, Möllmann H
Aims
Both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are established options to treat aortic valve stenosis. We present the outcome of the complete cohort of all patients undergoing SAVR or TAVI in Germany during the calendar year 2019.
Methods and results
Data concerning all isolated aortic valve procedures performed in Germany in 2019 were retrieved from the mandatory nationwide quality control program: 22,973 transvascular (TV)-TAVI procedures, 7905 isolated SAVR (iSAVR), and 1413 transapical (TA)-TAVI. Data was complete in 99.9% (n = 32,156). In-hospital mortality after TV-TAVI (2.3%) was significantly lower when compared with iSAVR (2.8%, p = 0.007) or TA-TAVI (6.3%; p < 0.001). Expected mortality was calculated with a new version of the German Aortic valve score (AKL Score) based on the data of either catheter-based (AKL-CATH) or surgical (AKL-CHIR) aortic valve replacements in Germany in 2018. TV-TAVI and iSAVR both showed lower observed mortality in 2019 than expected based on their respective performance in 2018, yielding an observed/expected (O/E) mortality ratio < 1. This was particularly apparent for patients at low risk. After exclusion of emergency procedures, in-hospital mortality after TV-TAVI (2.1%) and after iSAVR (2.1%) was identical, even though patients undergoing TV-TAVI showed a considerably higher perioperative risk profile.
Conclusion
After excluding emergency procedures, in-hospital mortality of TV-TAVI and iSAVR in 2019 in Germany was identical. In 2019, TV-TAVI and iSAVR both show lower matched mortality ratios compared with 2018, which suggests technical improvements of both therapies.



Clin Res Cardiol: 27 Feb 2021; 110:460-465
Gaede L, Blumenstein J, Husser O, Liebetrau C, ... Achenbach S, Möllmann H
Clin Res Cardiol: 27 Feb 2021; 110:460-465 | PMID: 33389039
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Impact:
Abstract

Combined renal and common hepatic artery denervation as a novel approach to reduce cardiometabolic risk: technical approach, feasibility and safety in a pre-clinical model.

Kiuchi MG, Ganesan K, Keating J, Carnagarin R, ... Adams L, Schlaich MP
Background
Cardiovascular and metabolic regulation is governed by neurohumoral signalling in relevant organs such as kidney, liver, pancreas, duodenum, adipose tissue, and skeletal muscle. Combined targeting of relevant neural outflows may provide a unique therapeutic opportunity for cardiometabolic disease.
Objectives
We aimed to investigate the feasibility, safety, and performance of a novel device-based approach for multi-organ denervation in a swine model over 30 and 90 days of follow-up.
Methods
Five Yorkshire cross pigs underwent combined percutaneous denervation in the renal arteries and the common hepatic artery (CHA) with the iRF Denervation System. Control animals (n = 3) were also studied. Specific energy doses were administered in the renal arteries and CHA. Blood was collected at 30 and 90 days. All animals had a pre-terminal procedure angiography. Tissue samples were collected for norepinephrine (NEPI) bioanalysis. Histopathological evaluation of collateral structures and tissues near the treatment sites was performed to assess treatment safety.
Results
All animals entered and exited the study in good health. No stenosis or vessel abnormalities were present. No significant changes in serum chemistry occurred. NEPI concentrations were significantly reduced in the liver (- 88%, p = 0.005), kidneys (- 78%, p < 0.001), pancreas (- 78%, p = 0.018) and duodenum (- 95%, p = 0.028) following multi-organ denervation treatment compared to control animals. Histologic findings were consistent with favourable tissue responses at 90 days follow-up.
Conclusions
Significant and sustained denervation of the treated organs was achieved at 90 days without major safety events. Our findings demonstrate the feasibility of multi-organ denervation using a novel iRF Denervation System in a single procedure.



Clin Res Cardiol: 25 Feb 2021; epub ahead of print
Kiuchi MG, Ganesan K, Keating J, Carnagarin R, ... Adams L, Schlaich MP
Clin Res Cardiol: 25 Feb 2021; epub ahead of print | PMID: 33635438
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Impact:
Abstract

Critical appraisal of the 2020 ESC guideline recommendations on diagnosis and risk assessment in patients with suspected non-ST-segment elevation acute coronary syndrome.

Giannitsis E, Blankenberg S, Christenson RH, Frey N, ... Wollert KC, Huber K
Multiple new recommendations have been introduced in the 2020 ESC guidelines for the management of acute coronary syndromes with a focus on diagnosis, prognosis, and management of patients presenting without persistent ST-segment elevation. Most recommendations are supported by high-quality scientific evidence. The guidelines provide solutions to overcome obstacles presumed to complicate a convenient interpretation of troponin results such as age-, or sex-specific cutoffs, and to give practical advice to overcome delays of laboratory reporting. However, in some areas, scientific support is less well documented or even missing, and other areas are covered rather by expert opinion or subjective recommendations. We aim to provide a critical appraisal on several recommendations, mainly related to the diagnostic and prognostic assessment, highlighting the discrepancies between Guideline recommendations and the existing scientific evidence.



Clin Res Cardiol: 25 Feb 2021; epub ahead of print
Giannitsis E, Blankenberg S, Christenson RH, Frey N, ... Wollert KC, Huber K
Clin Res Cardiol: 25 Feb 2021; epub ahead of print | PMID: 33635437
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Impact:
Abstract

Preload dependence of pulmonary haemodynamics and right ventricular performance.

Gual-Capllonch F, Lupón J, Bancu I, Graterol F, ... Juncà G, Bayes-Genis A
Aims
Systolic pulmonary artery pressure (SPAP) and right heart adaptation in relation to pre-existing preload are often disregarded. To determine volume-related changes in the pulmonary-right ventricle (RV) unit and the preload dependence of its components, we analysed pulmonary haemodynamics and right ventricular performance, taking advantage of the plasma volume removal associated to haemodialysis (HD).
Methods and results
Fifty-three stable patients on chronic HD with LVEF > 50% and without heart failure were recruited (mean age 63.0 ± 12.4 years; 31.2% women; hypertension in 89% and diabetes in 53%) and evaluated just before and after HD (mean ultrafiltration volume 2.4 ± 0.7 l). SPAP from both times were available in 39 patients. After HD, SPAP decreased (42.2 ± 12.6 to 33.7 ± 11.6 mmHg, p < 0.001) without modification of non-invasive pulmonary vascular resistance (1.75 ± 0.44 to 1.75 ± 0.40 eWU, p = 0.94). Age and drop in the E/e\' ratio were the variables associated with greater reduction in PASP (p = 0.022 and p = 0.049, respectively). A significant reduction of right chamber sizes was observed, along with a diminution in measures of RV contractility, excluding RV longitudinal strain. Functional tricuspid regurgitation (FTR) diminution was observed in 26% of patients, occurring in every case with more than mild FTR. On multivariate analyses, left atrial size was the only predictor of pulmonary hypertension (defined as SPAP > 40 mmHg) (OR 1.29 (1.07-1.56), p = 0.006).
Conclusion
Rapid volemic changes may affect FTR grading, RV size and contractility, with RV longitudinal strain being less variable than conventional parameters. SPAP decreases after HD, and this reduction is related to age and greater diminution of the E/e\' ratio.



Clin Res Cardiol: 23 Feb 2021; epub ahead of print
Gual-Capllonch F, Lupón J, Bancu I, Graterol F, ... Juncà G, Bayes-Genis A
Clin Res Cardiol: 23 Feb 2021; epub ahead of print | PMID: 33624153
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Impact:
Abstract

The importance of including uric acid in the definition of metabolic syndrome when assessing the mortality risk.

Pugliese NR, Mengozzi A, Virdis A, Casiglia E, ... Borghi C, Working Group on Uric Acid and Cardiovascular Risk of the Italian Society of Hypertension
Introduction
Serum uric acid (SUA) has been depicted as a contributory causal factor in metabolic syndrome (MS), which in turn, portends unfavourable prognosis.
Aim
We assessed the prognostic role of SUA in patients with and without MS.
Methods
We used data from the multicentre Uric Acid Right for Heart Health study and considered cardiovascular mortality (CVM) as death due to fatal myocardial infarction, stroke, sudden cardiac death, or heart failure.
Results
A total of 9589 subjects (median age 58.5 years, 45% males) were included in the analysis, and 5100 (53%) patients had a final diagnosis of MS. After a median follow-up of 142 months, we observed 558 events. Using a previously validated cardiovascular SUA cut-off to predict CVM (> 5.1 mg/dL in women and 5.6 mg/dL in men), elevated SUA levels were significantly associated to a worse outcome in patients with and without MS (all p < 0.0001) and provided a significant net reclassification improvement of 7.1% over the diagnosis of MS for CVM (p = 0.004). Cox regression analyses identified an independent association between SUA and CVM (Hazard Ratio: 1.79 [95% CI, 1.15-2.79]; p < 0.0001) after the adjustment for MS, its single components and renal function. Three specific combinations of the MS components were associated with higher CVM when increasing SUA levels were reported, and systemic hypertension was the only individual component ever-present (all p < 0.0001).
Conclusion
Increasing SUA levels are associated with a higher CVM risk irrespective of the presence of MS: a cardiovascular SUA threshold may improve risk stratification.



Clin Res Cardiol: 17 Feb 2021; epub ahead of print
Pugliese NR, Mengozzi A, Virdis A, Casiglia E, ... Borghi C, Working Group on Uric Acid and Cardiovascular Risk of the Italian Society of Hypertension
Clin Res Cardiol: 17 Feb 2021; epub ahead of print | PMID: 33604722
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Impact:
Abstract

Pathomechanisms and therapeutic opportunities in radiation-induced heart disease: from bench to bedside.

Sárközy M, Varga Z, Gáspár R, Szűcs G, ... Kahán Z, Csont T
Cancer management has undergone significant improvements, which led to increased long-term survival rates among cancer patients. Radiotherapy (RT) has an important role in the treatment of thoracic tumors, including breast, lung, and esophageal cancer, or Hodgkin\'s lymphoma. RT aims to kill tumor cells; however, it may have deleterious side effects on the surrounding normal tissues. The syndrome of unwanted cardiovascular adverse effects of thoracic RT is termed radiation-induced heart disease (RIHD), and the risk of developing RIHD is a critical concern in current oncology practice. Premature ischemic heart disease, cardiomyopathy, heart failure, valve abnormalities, and electrical conduct defects are common forms of RIHD. The underlying mechanisms of RIHD are still not entirely clear, and specific therapeutic interventions are missing. In this review, we focus on the molecular pathomechanisms of acute and chronic RIHD and propose preventive measures and possible pharmacological strategies to minimize the burden of RIHD.



Clin Res Cardiol: 15 Feb 2021; epub ahead of print
Sárközy M, Varga Z, Gáspár R, Szűcs G, ... Kahán Z, Csont T
Clin Res Cardiol: 15 Feb 2021; epub ahead of print | PMID: 33591377
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Impact:
Abstract

Pacemaker lead-associated tricuspid regurgitation in patients with or without pre-existing right ventricular dilatation.

Riesenhuber M, Spannbauer A, Gwechenberger M, Pezawas T, ... Hengstenberg C, Gyongyosi M
Background
Transcatheter tricuspid valve intervention became an option for pacemaker lead-associated tricuspid regurgitation. This study investigated the progression of tricuspid regurgitation (TR) in patients with or without pre-existing right ventricular dilatation (RVD) undergoing pacemaker implantation.
Methods
Patients were included if they had implantation of transtricuspid pacemaker lead and completed echocardiography before and after implantation. The cohort was divided in patients with and without RVD (cut-off basal RV diameter ≥ 42 mm). TR was graded in none/mild, moderate, and severe. Worsening of one grade was defined as progression. Survival analyses were plotted for 10 years.
Results
In total, 990 patients were analyzed (24.5% with RVD). Progression of TR occurred in 46.1% of patients with RVD and in 25.6% of patients without RVD (P < 0.001). Predictors for TR progression were RV dilatation (OR 2.04; 95% CI 1.27-3.29; P = 0.003), pre-existing TR (OR 4.30; 95% CI 2.51-7.38; P < 0.001), female sex (OR 1.68; 95% CI 1.16-2.43; P = 0.006), single RV lead (OR 1.67; 95% CI 1.09-2.56; P = 0.018), mitral regurgitation (OR 2.08; 95% CI 1.42-3.05; P < 0.001), and enlarged left atrium (OR 1.98; 95% CI 1.07-3.67; P = 0.03). Survival-predictors were pacemaker lead-associated TR (HR 1.38; 95% CI 1.04-1.84; P = 0.028), mitral regurgitation (HR 1.34; 95% CI 1.02-1.77; P = 0.034), heart failure (HR 1.75; 95% CI 1.31-2.33; P < 0.001), kidney disease (HR 1.62; 95% CI 1.25-2.11; P < 0.001), and age ≥ 80 years (HR 2.84; 95% CI 2.17-3.71; P < 0.001).
Conclusions
Patients with RVD receiving pacemaker suffered from increased TR progression, leading to decreased survival.



Clin Res Cardiol: 09 Feb 2021; epub ahead of print
Riesenhuber M, Spannbauer A, Gwechenberger M, Pezawas T, ... Hengstenberg C, Gyongyosi M
Clin Res Cardiol: 09 Feb 2021; epub ahead of print | PMID: 33566185
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Impact:
Abstract

Impact of sinus rhythm versus atrial fibrillation on left ventricular remodeling after transcatheter aortic valve replacement.

Ledwoch J, Fröhlich C, Olbrich I, Poch F, ... Kupatt C, Hoppmann P
Aims
Atrial fibrillation (AF) is associated with increased mortality after transcatheter aortic valve replacement (TAVR). Cerebrovascular complications and bleeding events associated with anticoagulation therapy are discussed to be possible causes for this increased mortality. The present study sought to assess whether AF is associated with impaired left ventricular (LV) reverse remodeling representing another possible mechanism for poor outcome.
Methods
All patients who underwent TAVR in our institution and had 1-year echocardiography follow-up were included. LV mass index (LVMI) at baseline and follow-up as well as LVMI change at 1 year were assessed with respect to the presence of AF (either at baseline or during hospitalization after TAVR) and sinus rhythm (SR).
Results
A total of 213 patients (n = 95 in AF; n = 118 in SR) were enrolled in the present study. Patients with AF had higher LVMI at 1 year compared to those with SR (173 ± 61 g/m2 vs. 154 ± 55 g/m2; p = 0.02) and they showed lower relative LVMI change at 1 year (- 2 ± 28% vs. - 9 ± 29%; p = 0.04). In linear regression analysis, AF was independently associated with relative LVMI change (regression coefficient ß 0.076 [95% CI 0.001-0.150]; p = 0.04). With respect to clinical outcome depending on AF and LVMI regression, the Kaplan-Meier estimated event-free of death or cardiac rehospitalization at 3 years was lowest among patients with AF and no LVMI regression.
Conclusions
The present study identified a significant association of AF with changes in LVMI after TAVR, which was also shown to be associated with clinical outcome.



Clin Res Cardiol: 09 Feb 2021; epub ahead of print
Ledwoch J, Fröhlich C, Olbrich I, Poch F, ... Kupatt C, Hoppmann P
Clin Res Cardiol: 09 Feb 2021; epub ahead of print | PMID: 33566184
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Impact:
Abstract

Prognostic value of NT-proBNP for myocardial recovery in peripartum cardiomyopathy (PPCM).

Hoevelmann J, Muller E, Azibani F, Kraus S, ... Sliwa K, Viljoen CA
Introduction
Peripartum cardiomyopathy (PPCM) is an important cause of pregnancy-associated heart failure worldwide. Although a significant number of women recover their left ventricular (LV) function within 12 months, some remain with persistently reduced systolic function.
Methods
Knowledge gaps exist on predictors of myocardial recovery in PPCM. N-terminal pro-brain natriuretic peptide (NT-proBNP) is the only clinically established biomarker with diagnostic value in PPCM. We aimed to establish whether NT-proBNP could serve as a predictor of LV recovery in PPCM, as measured by LV end-diastolic volume (LVEDD) and LV ejection fraction (LVEF).
Results
This study of 35 women with PPCM (mean age 30.0 ± 5.9 years) had a median NT-proBNP of 834.7 pg/ml (IQR 571.2-1840.5) at baseline. Within the first year of follow-up, 51.4% of the cohort recovered their LV dimensions (LVEDD < 55 mm) and systolic function (LVEF > 50%). Women without LV recovery presented with higher NT-proBNP at baseline. Multivariable regression analyses demonstrated that NT-proBNP of ≥ 900 pg/ml at the time of diagnosis was predictive of failure to recover LVEDD (OR 0.22, 95% CI 0.05-0.95, P = 0.043) or LVEF (OR 0.20 [95% CI 0.04-0.89], p = 0.035) at follow-up.
Conclusions
We have demonstrated that NT-proBNP has a prognostic value in predicting LV recovery of patients with PPCM. Patients with NT-proBNP of ≥ 900 pg/ml were less likely to show any improvement in LVEF or LVEDD. Our findings have implications for clinical practice as patients with higher NT-proBNP might require more aggressive therapy and more intensive follow-up. Point-of-care NT-proBNP for diagnosis and risk stratification warrants further investigation.



Clin Res Cardiol: 07 Feb 2021; epub ahead of print
Hoevelmann J, Muller E, Azibani F, Kraus S, ... Sliwa K, Viljoen CA
Clin Res Cardiol: 07 Feb 2021; epub ahead of print | PMID: 33555408
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Impact:
Abstract

Acute chest pain with ST-segment elevation in lead V1-V3: when you hear hoofbeats, also look for zebras.

Pascale P, Pavon AG, Bogaert J, Bennett J, ... Schwitter J, Masci PG
ST-segment elevation (STE) in the anterior precordial leads is the hallmark of anterior myocardial infarction. In rare cases, this ECG pattern may be due to isolated infarction of the right ventricle since leads V1-V3 directly overlie the right ventricular free wall. Herein, we aimed to provide clues to recognize and understand this diagnostic pitfall through a series of 4 patients presenting with STE in the anterior leads.



Clin Res Cardiol: 05 Feb 2021; epub ahead of print
Pascale P, Pavon AG, Bogaert J, Bennett J, ... Schwitter J, Masci PG
Clin Res Cardiol: 05 Feb 2021; epub ahead of print | PMID: 33547960
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Impact:
Abstract

Prognostic impact of mean heart rate by Holter monitoring on long-term outcome in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention.

Shen J, Liu G, Yang Y, Li X, ... Huang B, Luo S
Background
Previous studies have shown elevated admission heart rate (HR) was associated with worse outcome in patients with myocardial infarction (MI). However, the prognostic value of mean heart rate (MHR) with Holter monitoring remains unclear.
Objectives
Our present study aims to evaluate the impact of MHR by Holter monitoring on long-term mortality in patients with ST-segment elevation myocardial infarction (STEMI).
Methods
1013 STEMI patients were divided into four groups according to the quartiles of MHR by Holter monitoring, Q1 (< 66 bpm), Q2 66-72 bpm), Q3 (73-78 bpm), and Q4 (> 78 bpm). The endpoint was long-term all-cause mortality. The predictive value of admission HR, discharge HR, and MHR was compared with receiver operating characteristic (ROC) curves.
Results
Patients in Q4 were more likely to present with anterior MI, high Killip class, relatively lower admission blood pressure, significantly increased troponin I, B-type natriuretic peptide, and decreased left ventricular ejection fraction. During a median of 28.3 months follow up period, 91 patients (8.9%) died. The mortality in Q4 was significantly higher than in the other three groups (P < 0.001). After multivariate adjustment, Q4 was associated with a 1.0-fold increased risk of long-term all-cause mortality (HR = 2.096, 95% CI 1.190-3.691, P = 0.010). ROC analysis shows MHR with Holter (AUC = 0.672) was superior to admission HR (AUC = 0.556) or discharge HR (AUC = 0.578).
Conclusions
MHR based on Holter monitoring provided important prognostic value and MHR > 78 bpm was independently associated with increased risk of long-term all-cause mortality in patients with STEMI, and its predictive validity was superior to admission or discharge HR.



Clin Res Cardiol: 05 Feb 2021; epub ahead of print
Shen J, Liu G, Yang Y, Li X, ... Huang B, Luo S
Clin Res Cardiol: 05 Feb 2021; epub ahead of print | PMID: 33547959
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Impact:
Abstract

Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial.

Richardt G, Abdelghani M, Allali A, Toelg R, ... Stoll HP, Urban P
Aims
To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS.
Methods
This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR).
Results
Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178-1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079-0.996], p = 0.036), and BARC 3-5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012-12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947).
Conclusions
Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.



Clin Res Cardiol: 30 Jan 2021; 110:162-171
Richardt G, Abdelghani M, Allali A, Toelg R, ... Stoll HP, Urban P
Clin Res Cardiol: 30 Jan 2021; 110:162-171 | PMID: 32440723
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Impact:
Abstract

Different vasoreactivity of arterial bypass grafts versus native coronary arteries in response to acetylcholine.

Pirozzolo G, Seitz A, Martínez Pereyra V, Athanasiadis A, ... Sechtem U, Ong P
Background
Coronary angiography is often performed in patients with recurrent angina after successful coronary artery bypass grafting (CABG) in search of the progression of atherosclerosis. However, in many of these patients, no relevant stenosis can be detected. We speculate that coronary spasm may be associated with angina in these patients.
Methods
From 2307 patients with unobstructed coronaries who underwent intracoronary acetylcholine spasm provocation testing (ACh-test) between 2012 and 2016, 54 consecutive patients who fulfilled the following inclusion criteria were included in this cohort study: previous left internal thoracic artery (LITA) bypass on the left anterior descending (LAD) coronary artery, ongoing/recurrent angina pectoris, no significant (< 50%) coronary artery or bypass stenosis. In all participants, the ACh-test was performed via the LITA bypass.
Results
In 14 patients (26%) the ACh-test elicited epicardial spasm of the LAD distal to the anastomosis (≥ 90% diameter reduction with reproduction of the patient\'s symptoms and ischemic ECG shifts). Microvascular spasm (reproduction of symptoms and ischemic ECG-changes but no epicardial spasm) was seen in 30 patients (55%). The ACh-test was normal in the remaining 10 patients (19%). ACh-testing did not elicit any relevant vasoconstriction in the LITA bypasses in contrast to the LAD on quantitative coronary analyses (4.89 ± 7.36% vs. 52.43 ± 36.07%, p < 0.01).
Conclusion
Epicardial and microvascular coronary artery spasm are frequent findings in patients with ongoing or recurrent angina after CABG but no relevant stenosis. Vasoreactivity to acetylcholine is markedly different between LITA bypasses and native LAD arteries with vasoconstriction almost exclusively occurring in the LAD.



Clin Res Cardiol: 30 Jan 2021; 110:172-182
Pirozzolo G, Seitz A, Martínez Pereyra V, Athanasiadis A, ... Sechtem U, Ong P
Clin Res Cardiol: 30 Jan 2021; 110:172-182 | PMID: 32613293
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Impact:
Abstract

The impact of SSRIs on mortality and cardiovascular events in patients with coronary artery disease and depression: systematic review and meta-analysis.

Fernandes N, Prada L, Rosa MM, Ferreira JJ, ... Pinto FJ, Caldeira D
Background
Depression is common in patients after acute coronary syndromes (ACS) and with stable coronary artery disease (CAD) and has been associated with increased mortality and morbidity. However, it is unclear whether selective serotonin receptor inhibitors (SSRIs) reduce mortality or cardiac events in patients with CAD and depression.
Objective
We conducted a systematic review and meta-analysis to assess the effects of SSRIs on cardiovascular events in depressed CAD patients.
Methods
The CENTRAL, MEDLINE, and PsycINFO databases were searched (April 2020) for randomized controlled trials (RCTs) and extended follow-up analyses of RCTs that compared SSRIs with placebo or no intervention in patients with CAD and depression. The primary outcomes were all-cause mortality, cardiovascular mortality, and myocardial infarction incidence. The results were calculated through random-effect meta-analyses and reported in terms of risk ratio (RR) with 95% confidence intervals (CI).
Results
We retrieved 8 RCTs (2 of which with extended follow-up analyses), comprising a total of 1148 patients. 7 studies only included post-ACS patients. SSRIs were associated with a significantly lower risk of myocardial infarction in patients with CAD and depression (RR 0.54, 95% CI 0.34-0.86), and in post-ACS patients with depression (RR 0.56, 95% CI 0.35-0.90). We found no statistically significant difference in all-cause mortality, cardiovascular mortality, hospitalizations, angina, congestive heart failure, or stroke incidence.
Conclusion
The use of SSRIs in post-ACS patients with depression was associated with a 44% relative risk reduction of myocardial infarction. No difference in mortality was found. Given that the quality of the evidence was low, further research is warranted.



Clin Res Cardiol: 30 Jan 2021; 110:183-193
Fernandes N, Prada L, Rosa MM, Ferreira JJ, ... Pinto FJ, Caldeira D
Clin Res Cardiol: 30 Jan 2021; 110:183-193 | PMID: 32617669
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Impact:
Abstract

Instant rule-out of suspected non-ST-segment elevation myocardial infarction using high-sensitivity cardiac troponin T with Copeptin versus a single low high-sensitivity cardiac troponin T: findings from a large pooled individual data analysis on 10,329 patients.

Giannitsis E, Huber K, Hamm CW, Möckel M
Background
Evidence is sparse and inconsistent on the role of a dual marker strategy (DMS) combining Copeptin with cardiac troponin T (cTnT) for instant rule-out of a non-ST-segment myocardial infarction (NSTEMI) when high sensitivity cardiac troponin T (hs-cTnT) is used.
Methods
Data on 10,329 patients from 5 trials were pooled to evaluate initial Copeptin in combination with hs-cTnT against a single marker strategy (SMS) based on hs-cTnT < limit of detection. Endpoints were sensitivities and negative predictive values (NPV) for rule-out of NSTEMI, 30-day all-cause mortality and rates of applicability for DMS or SMS.
Results
NPV for rule-out of NSTEMI was high, exceeding 99.0% for the lower limits of the 95% confidence intervals (99.0% vs 99.2%) for DMS and SMS, and NPV for all cause death at 30 days was similar with very low mortality after rule-out [0.07% (0.0-0.4%) vs 0.0% (0.0-1.2%), p = 1.0], but applicability was 2.4-fold higher [64.6% (63.0-66.2%) vs 27.9% (26.2%-29.7%), p < 0.001] with DMS than SMS. In a secondary analysis on DMS after inclusion of high risk patients, performance and applicability were similar.
Conclusion
Findings corroborate the 2015 European Society of Cardiology recommendation to use dual marker strategy for instant rule-out of NSTEMI, extending evidence to hs-cTnT. Novel data demonstrate a comparably safe and effective instant rule-out with Copeptin in combination with hs-cTnT versus a single marker strategy based on very low hs-cTnT but a more than twofold higher applicability of the dual marker strategy without the need to exclude very early presenters or other important subgroups. Dual marker strategy using hs-cTnT at 99th percentile and Copeptin versus ESC 0-h immediate rule-out based on hs-cTnT < limit of detection.



Clin Res Cardiol: 30 Jan 2021; 110:194-199
Giannitsis E, Huber K, Hamm CW, Möckel M
Clin Res Cardiol: 30 Jan 2021; 110:194-199 | PMID: 32671467
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Impact:
Abstract

New technologies for intensive prevention programs after myocardial infarction: rationale and design of the NET-IPP trial.

Wienbergen H, Fach A, Erdmann J, Katalinic A, ... Hambrecht R, Langer H
Introduction
Current health care data reveal suboptimal prevention in patients with coronary artery disease and an unmet need to develop effective preventive strategies. The New Technologies for Intensive Prevention Programs (NET-IPP) Trial will investigate if a long-term web-based prevention program after myocardial infarction (MI) will reduce clinical events and risk factors. In a genetic sub study the impact of disclosure of genetic risk using polygenic risk scores (PRS) will be assessed.
Study design
Patients hospitalized for MI will be prospectively enrolled and assigned to either a 12-months web-based intensive prevention program or standard care. The web-based program will include telemetric transmission of risk factor data, e-learning and electronic contacts between a prevention assistant and the patients. The combined primary study endpoint will comprise severe adverse cardiovascular events after 2 years. Secondary endpoints will be risk factor control, adherence to medication and quality of life. In a genetic sub study genetic risk will be assessed in all patients of the web-based intensive prevention program group by PRS and patients will be randomly assigned to genetic risk disclosure vs. no disclosure. The study question will be if disclosure of genetic risk has an impact on patient motivation and cardiovascular risk factor control.
Conclusions
The randomized multicenter NET-IPP study will evaluate for the first time the effects of a long-term web-based prevention program after MI on clinical events and risk factor control. In a genetic sub study the impact of disclosure of genetic risk using PRS will be investigated.



Clin Res Cardiol: 30 Jan 2021; 110:153-161
Wienbergen H, Fach A, Erdmann J, Katalinic A, ... Hambrecht R, Langer H
Clin Res Cardiol: 30 Jan 2021; 110:153-161 | PMID: 32734504
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Impact:
Abstract

Genetically determined intelligence and coronary artery disease risk.

Li L, Pang S, Zeng L, Güldener U, Schunkert H
Background
Epidemiological studies have shown inverse association between intelligence and coronary artery disease (CAD) risk, but the underlying mechanisms remain unclear.
Methods
Based on 242 SNPs independently associated with intelligence, we calculated the genetic intelligence score (gIQ) for participants from 10 CAD case-control studies (n = 34,083) and UK Biobank (n = 427,306). From UK Biobank, we extracted phenotypes including body mass index (BMI), type 2 diabetes (T2D), smoking, hypertension, HDL cholesterol, LDL cholesterol, measured intelligence score, and education attainment. To estimate the effects of gIQ on CAD and its related risk factors, regression analyses was applied. Next, we studied the mediatory roles of measured intelligence and educational attainment. Lastly, Mendelian randomization was performed to validate the findings.
Results
In CAD case-control studies, one standard deviation (SD) increase of gIQ was related to a 5% decrease of CAD risk (odds ratio [OR] of 0.95; 95% confidence interval [CI] 0.93 to 0.98; P = 4.93e-5), which was validated in UK Biobank (OR = 0.97; 95% CI 0.96 to 0.99; P = 6.4e-4). In UK Biobank, we also found significant inverse correlations between gIQ and risk factors of CAD including smoking, BMI, T2D, hypertension, and a positive correlation with HDL cholesterol. The association signals between gIQ and CAD as well as its risk factors got largely attenuated after the adjustment of measured intelligence and educational attainment. The causal role of intelligence in mediating CAD risk was confirmed by Mendelian randomization analyses.
Conclusion
Genetic components of intelligence affect measured intelligence and educational attainment, which subsequently affect the prevalence of CAD via a series of unfavorable risk factor profiles.



Clin Res Cardiol: 30 Jan 2021; 110:211-219
Li L, Pang S, Zeng L, Güldener U, Schunkert H
Clin Res Cardiol: 30 Jan 2021; 110:211-219 | PMID: 32740755
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Impact:
Abstract

Assessment of coronary artery disease during hospitalization for cancer treatment.

Mrotzek SM, Lena A, Hadzibegovic S, Ludwig R, ... Anker MS, Totzeck M
Background
With improvement of cancer-specific survival, comorbidities and treatment-related side effects, particularly cardiovascular toxicities, need close attention. The aim of the present study was to evaluate clinical characteristics and outcomes of cancer patients requiring coronary angiography during inpatient care.
Methods
We performed a retrospective analysis of patients hospitalized between 02/2011 and 02/2018 in our two university hospital cancer centers. From a cohort of 60,676 cancer patients, we identified 153 patients (65.7 ± 11.6 years, 73.2% male), who underwent coronary angiography and were eligible for analysis. These were compared to a control group of 153 non-cancer patients pair-matched with respect to age, sex, and indication for catheterization.
Results
Cancer patients presented in 66% with an acute coronary syndrome (ACS). The most prevalent cancer entities were lymphoma (19%) and lung cancer (18.3%). The rate of primary percutaneous coronary interventions (PCI) was significantly lower in the cancer cohort (40.5% vs. 53.6%, p = 0.029), although manifestation of coronary artery disease (CAD) and PCI results were comparable (SYNergy between PCI with TAXus and cardiac surgery (SYNTAX)-score, delta pre- and post-PCI - 9.8 vs. - 8.0, p = 0.2). Mortality was remarkably high in cancer patients (1-year mortality 46% vs. 8% in non-cancer patients, p < 0.001), particularly with troponin-positive ACS (5-year mortality 71%).
Conclusion
Strategies to effectively control cardiovascular risks in cancer patients are needed. Additionally, suspected CAD in cancer patients should not prevent prompt diagnostic clarification and optimal revascularization as PCI results in cancer patients are comparable to non-cancer patients and occurrence of troponin-positive ACS leads to a significantly increased risk of mortality.



Clin Res Cardiol: 30 Jan 2021; 110:200-210
Mrotzek SM, Lena A, Hadzibegovic S, Ludwig R, ... Anker MS, Totzeck M
Clin Res Cardiol: 30 Jan 2021; 110:200-210 | PMID: 32743679
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Impact:
Abstract

Differential clinical impact of chronic total occlusion revascularization based on left ventricular systolic function.

Kook H, Yang JH, Cho JY, Jang DH, ... Choi SH, Yu CW
Background
The effect of chronic total occlusion (CTO) revascularization on survival remains controversial. Furthermore, data regarding outcome differences for CTO revascularization based on left ventricular systolic function (LVSF) are limited. The differential outcomes from CTO revascularization in patients with preserved LVSF (PLVSF) versus reduced LVSF (RLVSF) were assessed.
Methods
A total of 2,173 CTO patients were divided into either a PLVSF (n = 1661, Ejection fraction ≥ 50%) or RLVSF (n = 512, < 50%) group. Clinical outcomes were compared between successful CTO revascularization (SCR) versus optimal medical therapy (OMT) within each group. The primary endpoint was a composite of all-cause death or non-fatal myocardial infarction. Inverse probability of treatment weighting for endpoint analysis and a contrast test for comparison of survival probability differences according to LVSF were used.
Results
Patients with RLVSF had a mean 37% ejection fraction (EF) and 19% had EF < 30%. The median follow-up duration was 1,138 days. Regardless of LVSF, the primary endpoint incidence was significantly lower in patients treated with SCR [RLVSF: 29.7% vs. 49.7%, hazard ratio (HR) = 0.46, 95% confidence interval (CI): 0.36-0.62, p < 0.0001; PLVSF 7.3% vs. 16.9%, HR = 0.68, 95% CI: 0.54-0.93, p = 0.0019], which was mainly driven by a reduction in cardiac death. The difference in survival probability was greater and became more pronounced over time in patients with RLVSF than with PLVSF (1-year, p = 0.197; 3-years, p = 0.048; 5-years, p = 0.036).
Conclusions
SCR was associated with better survival benefit than OMT regardless of LVSF. The benefit was greater and became more significant over time in patients with RLVSF versus PLVSF.



Clin Res Cardiol: 30 Jan 2021; 110:237-248
Kook H, Yang JH, Cho JY, Jang DH, ... Choi SH, Yu CW
Clin Res Cardiol: 30 Jan 2021; 110:237-248 | PMID: 32880002
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Impact:
Abstract

Impact of real-time angiographic co-registered optical coherence tomography on percutaneous coronary intervention: the OPTICO-integration II trial.

Schneider VS, Böhm F, Blum K, Riedel M, ... Landmesser U, Leistner DM
Aims
Longitudinal geographic mismatch (LGM) as well as edge dissections are associated with an increased risk of adverse events after percutaneous coronary intervention (PCI). Recently, a novel system of real-time optical coherence tomography (OCT) with angiographic co-registration (ACR) became available and allows matched integration of cross-sectional OCT images to angiography. The OPTICO-integration II trial sought to assess the impact of ACR for PCI planning on the risk of LGM and edge dissections.
Methods
A total of 84 patients were prospectively randomized to ACR-guided PCI, OCT-guided PCI (without co-registration), and angiography-guided PCI. Primary endpoint was a composite of major edge dissection and/or LGM as assessed by post-PCI OCT.
Results
The primary endpoint was significantly reduced in ACR-guided PCI (4.2%) as compared to OCT-guided PCI (19.1%; p = 0.03) and angiography-guided PCI (25.5%; p < 0.01). Rates of LGM were 4.2%, 17.0%, and 22.9% in the ACR-guided PCI, in the OCT-guided PCI, and the angiography-guided PCI groups, respectively (ACR vs. OCT p = 0.04; ACR vs. angiography p = 0.04). The number of major edge dissections was low and without significant differences among the study groups (0% vs. 2.1% vs. 4.3%).
Conclusion
This study for the first time demonstrates superiority of ACR-guided PCI over OCT- and angiography-guided PCI in reducing the composite endpoint of major edge dissection and LGM, which was meanly driven by a reduction of LGM.



Clin Res Cardiol: 30 Jan 2021; 110:249-257
Schneider VS, Böhm F, Blum K, Riedel M, ... Landmesser U, Leistner DM
Clin Res Cardiol: 30 Jan 2021; 110:249-257 | PMID: 32889633
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Impact:
Abstract

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study.

Merinopoulos I, Gunawardena T, Wickramarachchi U, Richardson P, ... Vassiliou VS, Eccleshall SC
Objectives
We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI).
Background
Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel.
Methods
We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan-Meier curves and Cox regression statistical models.
Results
We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis.
Conclusion
We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.



Clin Res Cardiol: 30 Jan 2021; 110:220-227
Merinopoulos I, Gunawardena T, Wickramarachchi U, Richardson P, ... Vassiliou VS, Eccleshall SC
Clin Res Cardiol: 30 Jan 2021; 110:220-227 | PMID: 32876814
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Impact:
Abstract

Dual-axis rotational coronary angiography versus conventional coronary angiography: a randomized comparison.

Hell MM, Gilg MD, Röther J, Blachutzik F, Achenbach S, Schlundt C
Background
Dual-axis of rotational coronary angiography (RA), with one single cine acquisition during continuous C-arm motion along a pre-described path, is an alternative to conventional coronary angiography (CA). We assessed the performance of RA versus CA in a modern, experienced cath lab setting.
Methods
Sixty-seven patients with suspected coronary artery disease undergoing invasive coronary angiography were randomized to CA (n = 35) or dual-axis RA (n = 32). CA was performed with four left and two right coronary artery acquisitions with manual contrast medium injection. In RA, one cine acquisition each was performed for the left (5 projections) and right coronary artery (3 projections) with a fixed amount of contrast medium applied by a power injector. In both groups, single cine acquisitions in additional angulations were performed to fully interpret the coronary system, if necessary. Procedural parameters and outcome were compared.
Results
Mean age was 63 ± 12 years (64% males). Six additional projections were required in the RA group compared to 13 in the CA group (p = 0.173). Fluoroscopy duration (CA: 3 ± 3 min, RA: 3 ± 2 min, p = 0.748) and dose area product (CA: 1291 ± 761 µGym2, RA: 1476 ± 679 µGym2, p = 0.235) did not differ significantly between both groups. For CA, the amount of contrast medium (42 ± 13 vs. 46 ± 8 ml, p = 0.022) and procedure time (8 ± 5 vs. 11 ± 3 min, p < 0.001) were significantly lower. No major adverse event occurred during hospital stay.
Conclusions
Dual-axis RA represents a feasible and safe alternative method to CA for obtaining coronary angiograms. However, no superiority was observed when performed by an experienced interventionalist with a modern system.



Clin Res Cardiol: 30 Jan 2021; 110:258-269
Hell MM, Gilg MD, Röther J, Blachutzik F, Achenbach S, Schlundt C
Clin Res Cardiol: 30 Jan 2021; 110:258-269 | PMID: 32936322
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Impact:
Abstract

Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies.

Blachutzik F, Honton B, Escaned J, Hill JM, ... Hamm C, Nef HM
Background
The aim of this study was to assess the safety and effectiveness of intravascular lithotripsy (IVL) in treating eccentric calcified coronary lesions.
Methods
Between December 2015 and March 2019, 180 patients were enrolled in the Disrupt CAD I and CAD II studies across 19 sites in 10 countries. Patient-level data were pooled from these two studies (n = 180), within which 47 eccentric lesions (26%) and 133 concentric lesions were identified.
Results
Clinical success, defined as residual stenosis < 50% after stenting and no in-hospital MACE, was similar between the eccentric and concentric cohorts (93.6% vs. 93.2%, p = 1.0). There were no perforations, abrupt closure, slow flow or no reflow events observed in either group, and there were low rates of flow-limiting dissections (Grade D-F: 0% eccentric, 1.7% concentric; p = 0.54). Final acute gain and percent residual stenosis were similar between the two groups. Final residual stenosis of 8.6 ± 9.8% in eccentric and 10.0 ± 9.0% (p = 0.56) in concentric stenosis confirms the significant effect of IVL in calcified coronary lesions.
Conclusion
In this first report from a pooled patient-level analysis of coronary IVL from the Disrupt CAD I and CAD II studies, IVL use was associated with consistent improvement in procedural and clinical outcomes in both eccentric and concentric calcified lesions.



Clin Res Cardiol: 30 Jan 2021; 110:228-236
Blachutzik F, Honton B, Escaned J, Hill JM, ... Hamm C, Nef HM
Clin Res Cardiol: 30 Jan 2021; 110:228-236 | PMID: 32948882
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Impact:
Abstract

Prognostic impact of coronary chronic total occlusion on recurrences of ventricular tachyarrhythmias and ICD therapies.

Behnes M, Mashayekhi K, Kuche P, Kim SH, ... Lang S, Akin I
Background
Despite a few studies evaluating the prognostic impact of coronary chronic total occlusion (CTO) in implantable cardioverter defibrillator (ICD) recipients, the impact of CTO on different types of recurrences of ventricular tachyarrhythmias, as well as their predictors has not yet been investigated in CTO patients.
Methods
A large retrospective registry was used including all consecutive patients with ventricular tachyarrhythmias undergoing coronary angiography at index from 2002 to 2016. Only ICD recipients with CTO were compared to patients without (non-CTO). Kaplan-Meier and Cox regression analyses were applied for the primary end point of first recurrence of ventricular tachyarrhythmias at 5 years. Secondary end points comprised of the different types of recurrences, first appropriate ICD therapy and all-cause mortality at 5 years.
Results
From a total of 422 consecutive ICD recipients with ventricular tachyarrhythmias at index, at least one CTO was present in 25%. CTO was associated with the primary end point of first recurrence of ventricular tachyarrhythmias at 5 years (55% vs. 39%; log rank p = 0.001; HR = 1.665; 95% CI 1.221-2.271; p = 0.001), as well as increased risk of first appropriate ICD therapy (40% vs. 31%; log rank p = 0.039; HR = 1.454; 95% CI 1.016-2.079; p = 0.041) and all-cause mortality at 5 years (26% vs. 16%; log rank p = 0.011; HR = 1.797; 95% CI 1.133-2.850; p = 0.013). Less developed collaterals (i.e., either ipsi- or contralateral compared to bilateral) and a J-CTO score ≥ 3 were strongest predictors of recurrences in CTO patients at 5 years.
Conclusion
A coronary CTO even in the presence of less developed collaterals and more complex CTO category is associated with increasing risk of recurrent ventricular tachyarrhythmias at 5 years in consecutive ICD recipients.



Clin Res Cardiol: 30 Jan 2021; 110:281-291
Behnes M, Mashayekhi K, Kuche P, Kim SH, ... Lang S, Akin I
Clin Res Cardiol: 30 Jan 2021; 110:281-291 | PMID: 33150467
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Impact:
Abstract

Impact of the COVID-19 pandemic on cardiovascular mortality and catherization activity during the lockdown in central Germany: an observational study.

Nef HM, Elsässer A, Möllmann H, Abdel-Hadi M, ... Dörr O, CoVCAD –Study Group
Aims
During the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region.
Methods and results
Data from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99-1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01-1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05-1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures.
Conclusion
During the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.



Clin Res Cardiol: 30 Jan 2021; 110:292-301
Nef HM, Elsässer A, Möllmann H, Abdel-Hadi M, ... Dörr O, CoVCAD –Study Group
Clin Res Cardiol: 30 Jan 2021; 110:292-301 | PMID: 33219854
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Impact:
Abstract

\"Get with the Guidelines Heart Failure Risk Score\" for mortality prediction in patients undergoing MitraClip.

Iliadis C, Spieker M, Kavsur R, Metze C, ... Baldus S, Pfister R
Background
Reliable risk scores in patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) are lacking. Heart failure is common in these patients, and risk scores derived from heart failure populations might help stratify TMVR patients.
Methods
Consecutive patients from three Heart Centers undergoing TMVR were enrolled to investigate the association of the \"Get with the Guidelines Heart Failure Risk Score\" (comprising the variables systolic blood pressure, urea nitrogen, blood sodium, age, heart rate, race, history of chronic obstructive lung disease) with all-cause mortality.
Results
Among 815 patients with available data 177 patients died during a median follow-up time of 365 days. Estimated 1-year mortality by quartiles of the score (0-37; 38-42, 43-46 and more than 46 points) was 6%, 10%, 23% and 30%, respectively (p < 0.001), with good concordance between observed and predicted mortality rates (goodness of fit test p = 0.46). Every increase of one score point was associated with a 9% increase in the hazard of mortality (95% CI 1.06-1.11%, p < 0.001). The score was associated with long-term mortality independently of left ventricular ejection fraction, NYHA class and NTproBNP, and was equally predictive in primary and secondary mitral regurgitation.
Conclusion
The \"Get with the Guidelines Heart Failure Risk Score\" showed a strong association with mortality in patients undergoing TMVR with additive information beyond traditional risk factors. Given the routinely available variables included in this score, application is easy and broadly possible.



Clin Res Cardiol: 30 Jan 2021; epub ahead of print
Iliadis C, Spieker M, Kavsur R, Metze C, ... Baldus S, Pfister R
Clin Res Cardiol: 30 Jan 2021; epub ahead of print | PMID: 33517496
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Impact:
Abstract

Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study.

Wang R, Takahashi K, Garg S, Thuijs DJFM, ... Holmes DR, Serruys PW
Background
Coronary bypass artery grafting (CABG) has a higher procedural risk of stroke than percutaneous coronary intervention (PCI), but may offer better long-term survival. The optimal revascularization strategy for patients with prior cerebrovascular disease (CEVD) remains unclear.
Methods and results
The SYNTAXES study assessed the vital status out to 10 year of patients with three-vessel disease and/or left main coronary artery disease enrolled in the SYNTAX trial. The relative efficacy of PCI vs. CABG in terms of 10 year all-cause death was assessed according to prior CEVD. The primary endpoint was 10 year all-cause death. The status of prior CEVD was available in 1791 (99.5%) patients, of whom 253 patients had prior CEVD. Patients with prior CEVD were older and had more comorbidities (medically treated diabetes, insulin-dependent diabetes, metabolic syndrome, peripheral vascular disease, chronic obstructive pulmonary disease, impaired renal function, and congestive heart failure), compared with those without prior CEVD. Prior CEVD was an independent predictor of 10 year all-cause death (adjusted HR: 1.35; 95% CI: 1.04-1.73; p = 0.021). Patients with prior CEVD had a significantly higher risk of 10 year all-cause death (41.1 vs. 24.1%; HR: 1.92; 95% CI: 1.54-2.40; p < 0.001). The risk of 10 year all-cause death was similar between patients receiving PCI or CABG irrespective of the presence of prior CEVD (p-interaction = 0.624).
Conclusion
Prior CEVD was associated with a significantly increased risk of 10 year all-cause death which was similar in patients treated with PCI or CABG. These results do not support preferential referral for PCI rather than CABG in patients with prior CEVD.
Trial registration
SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.



Clin Res Cardiol: 29 Jan 2021; epub ahead of print
Wang R, Takahashi K, Garg S, Thuijs DJFM, ... Holmes DR, Serruys PW
Clin Res Cardiol: 29 Jan 2021; epub ahead of print | PMID: 33517534
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Impact:
Abstract

Outcomes in patients with acute myocardial infarction and new atrial fibrillation: a nationwide analysis.

Fauchier L, Bisson A, Bodin A, Herbert J, ... Danchin N, Cottin Y
Background
In patients with acute myocardial infarction (AMI), history of atrial fibrillation (AF) and new onset AF during the early phase may be associated with a worse prognosis. Whether both conditions are associated with similar outcomes is a matter of debate.
Methods
We collected information for all patients with AMI seen in French hospitals between 2010 and 2019. Among 797,212 patients seen with STEMI or NSTEMI, 75,701 (9.5%) had history of AF, and 34,768 (4.4%) had new AF diagnosed between day 1 and day 30 after AMI.
Results
Patients with new AF were older and had more comorbidities than those with no AF but were younger and had less comorbidities than those with history of AF. During follow-up [mean (SD) 1.8 (2.4) years, median (interquartile range) 0.7 (0.1-3.1) years], 163,845 deaths and 30,672 ischemic strokes were recorded. Using Cox multivariable analysis, compared to patients with no AF, history of AF was associated with a higher risk of death during follow-up (adjusted hazard ratio HR 1.17, 95% CI 1.16-1.19) and this was also the case for patients with new AF (adjusted HR 2.11, 2.07-2.15). Both history of AF and new AF were associated with a higher risk of ischemic stroke compared to patients with no AF: adjusted HR 1.19 (1.15-1.23) for history of AF, adjusted HR 1.78 (1.68-1.88) for new AF. New AF was associated with a higher risk of death and of ischemic stroke than history of AF: adjusted HR 1.74 (1.70-1.79) and 1.32 (1.23-1.42), respectively.
Conclusions
In a large and systematic nationwide analysis, AF first recorded in the first 30 days after AMI was independently associated with higher risks of death and ischemic stroke than those in patients with no AF or previously known AF.



Clin Res Cardiol: 27 Jan 2021; epub ahead of print
Fauchier L, Bisson A, Bodin A, Herbert J, ... Danchin N, Cottin Y
Clin Res Cardiol: 27 Jan 2021; epub ahead of print | PMID: 33507390
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Impact:
Abstract

Impaired in vitro growth response of plasma-treated cardiomyocytes predicts poor outcome in patients with transthyretin amyloidosis.

Hein S, Furkel J, Knoll M, Aus dem Siepen F, ... Kristen AV, Konstandin MH
Objectives
Direct toxic effects of transthyretin amyloid in patient plasma upon cardiomyocytes are discussed. However, no data regarding the relevance of this putative effect for clinical outcome are available. In this monocentric prospective study, we analyzed cellular hypertrophy after phenylephrine stimulation in vitro in the presence of patient plasma and correlated the cellular growth response with phenotype and prognosis.
Methods and results
Progress in automated microscopy and image analysis allows high-throughput analysis of cell morphology. Using the InCell microscopy system, changes in cardiomyocyte\'s size after treatment with patient plasma from 89 patients suffering from transthyretin amyloidosis and 16 controls were quantified. For this purpose, we propose a novel metric that we named Hypertrophic Index, defined as difference in cell size after phenylephrine stimulation normalized to the unstimulated cell size. Its prognostic value was assessed for multiple endpoints (HTX: death/heart transplantation; DMP: cardiac decompensation; MACE: combined) using Cox proportional hazard models. Cells treated with plasma from healthy controls and hereditary transthyretin amyloidosis with polyneuropathy showed an increase in Hypertrophic Index after phenylephrine stimulation, whereas stimulation after treatment with hereditary cardiac amyloidosis or wild-type transthyretin patient plasma showed a significantly attenuated response. Hypertrophic Index was associated in univariate analyses with HTX (hazard ratio (HR) high vs low: 0.12 [0.02-0.58], p = 0.004), DMP: (HR 0.26 [0.11-0.62], p = 0.003) and MACE (HR 0.24 [0.11-0.55], p < 0.001). Its prognostic value was independent of established risk factors, cardiac TroponinT or N-terminal prohormone brain natriuretic peptide (NTproBNP).
Conclusions
Attenuated cardiomyocyte growth response after stimulation with patient plasma in vitro is an independent risk factor for adverse cardiac events in ATTR patients.



Clin Res Cardiol: 21 Jan 2021; epub ahead of print
Hein S, Furkel J, Knoll M, Aus dem Siepen F, ... Kristen AV, Konstandin MH
Clin Res Cardiol: 21 Jan 2021; epub ahead of print | PMID: 33481097
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Impact:
Abstract

Short-term cardiac outcome in survivors of COVID-19: a systematic study after hospital discharge.

Sechi LA, Colussi G, Bulfone L, Brosolo G, ... Tascini C, Catena C
Background
COVID-19 has caused considerable morbidity and mortality worldwide and cardiac involvement has been reported during infection. The short-term cardiac outcome in survivors of COVID-19 is not known.
Objective
To examine the heart of patients who survived COVID-19 and to compare the cardiac outcome between patients who recovered from mild-to-moderate or severe illness.
Methods
With use of ECG and echocardiography, we examined the heart of 105 patients who had been hospitalized with COVID-19 and were consecutively recruited after hospital discharge while attending follow-up visits. Survivors of COVID-19 were compared with 105 matched controls. We also compared the cardiac outcome and lung ultrasound scan between COVID-19 patients who had mild-to-moderate or severe illness.
Results
Cardiac data were collected a median of 41 days from the first detection of COVID-19. Symptoms were present in a low percentage of patients. In comparison with matched controls, no considerable structural or functional differences were observed in the heart of survivors of COVID-19. Lung ultrasound scan detected significantly greater residual pulmonary involvement in COVID-19 patients who had recovered from severe than mild-to-moderate illness. No significant differences were detected in ECG tracings nor were found in the left and right ventricular function of patients who had recovered from mild-to-moderate or severe illness.
Conclusions
In a short-term follow-up, no abnormalities were identified in the heart of survivors of COVID-19, nor cardiac differences were detected between patients who had different severity of illness. With the limitations of a cross-sectional study, these findings suggest that patients who recover from COVID-19 do not have considerable cardiac sequelae.



Clin Res Cardiol: 21 Jan 2021; epub ahead of print
Sechi LA, Colussi G, Bulfone L, Brosolo G, ... Tascini C, Catena C
Clin Res Cardiol: 21 Jan 2021; epub ahead of print | PMID: 33481096
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Impact:
Abstract

Diagnosis and treatment of cardiac amyloidosis: position statement of the German Cardiac Society (DGK).

Yilmaz A, Bauersachs J, Bengel F, Büchel R, ... Aus dem Siepen F, Frey N
Systemic forms of amyloidosis affecting the heart are mostly light-chain (AL) and transthyretin (ATTR) amyloidoses. The latter is caused by deposition of misfolded transthyretin, either in wild-type (ATTRwt) or mutant (ATTRv) conformation. For diagnostics, specific serum biomarkers and modern non-invasive imaging techniques, such as cardiovascular magnetic resonance imaging (CMR) and scintigraphic methods, are available today. These imaging techniques do not only complement conventional echocardiography, but also allow for accurate assessment of the extent of cardiac involvement, in addition to diagnosing cardiac amyloidosis. Endomyocardial biopsy still plays a major role in the histopathological diagnosis and subtyping of cardiac amyloidosis. The main objective of the diagnostic algorithm outlined in this position statement is to detect cardiac amyloidosis as reliably and early as possible, to accurately determine its extent, and to reliably identify the underlying subtype of amyloidosis, thereby enabling subsequent targeted treatment.



Clin Res Cardiol: 17 Jan 2021; epub ahead of print
Yilmaz A, Bauersachs J, Bengel F, Büchel R, ... Aus dem Siepen F, Frey N
Clin Res Cardiol: 17 Jan 2021; epub ahead of print | PMID: 33459839
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Impact:
Abstract

Concomitant tricuspid regurgitation severity and its secondary reduction determine long-term prognosis after transcatheter mitral valve edge-to-edge repair.

Geyer M, Keller K, Bachmann K, Born S, ... Münzel T, von Bardeleben RS
Background
Concomitant tricuspid regurgitation (TR) is a common finding in mitral regurgitation (MR). Transcatheter repair (TMVR) is a favorable treatment option in patients at elevated surgical risk. To date, evidence on long-term prognosis and the prognostic impact of TR after TMVR is limited.
Methods
Long-term survival data of patients undergoing isolated edge-to-edge repair from June 2010 to March 2018 (combinations with other forms of TMVR or tricuspid valve therapy excluded) were analyzed in a retrospective monocentric study. TR severity was categorized and the impact of TR on survival was analysed.
Results
Overall, 606 patients [46.5% female, 56.4% functional MR (FMR)] were enrolled in this study. TR at baseline was categorized severe/medium/mild/no or trace in 23.2/34.3/36.3/6.3% of the cases. At 30-day follow-up, improvement of at least one TR-grade was documented in 34.9%. Severe TR at baseline was identified as predictor of 1-year survival [65.2% vs. 77.0%, p = 0.030; HR for death 1.68 (95% CI 1.12-2.54), p = 0.013] and in FMR-patients also regarding long-term prognosis [adjusted HR for long-term mortality 1.57 (95% CI 1.00-2.45), p = 0.049]. Missing post-interventional reduction of TR severity was predictive for poor prognosis, especially in the FMR-subgroup [1-year survival: 92.9% vs. 78.3%, p = 0.025; HR for death at 1-year follow-up 3.31 (95% CI 1.15-9.58), p = 0.027]. While BNP levels decreased in both subgroups, TR reduction was associated with improved symptomatic benefit (NYHA-class-reduction 78.6 vs. 65.9%, p = 0.021).
Conclusion
In this large study, both, severe TR at baseline as well as missing secondary reduction were predictive for impaired long-term prognosis, especially in patients with FMR etiology. TR reduction was associated with increased symptomatic benefit.



Clin Res Cardiol: 11 Jan 2021; epub ahead of print
Geyer M, Keller K, Bachmann K, Born S, ... Münzel T, von Bardeleben RS
Clin Res Cardiol: 11 Jan 2021; epub ahead of print | PMID: 33433670
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Impact:
Abstract

Impact of oral anticoagulation on clinical outcomes of COVID-19: a nationwide cohort study of hospitalized patients in Germany.

Fröhlich GM, Jeschke E, Eichler U, Thiele H, ... Landmesser U, Günster C
Objectives
The aim of this study was to investigate the impact of concomitant long-term medication-with a focus on ACE inhibitors and oral anticoagulation-on clinical outcomes in patients hospitalized with coronavirus disease 2019.
Methods
This is a retrospective cohort study using claims data of the biggest German health insurance company AOK, covering 26.9 million people all over Germany. In particular, patient-related characteristics and co-medication were evaluated. A multivariable logistic regression model was adopted to identify independent predictors for the primary outcome measure of all-cause mortality or need for invasive or non-invasive ventilation or extracorporeal membrane oxygenation.
Results
6637 patients in 853 German hospitals were included. The primary outcome occurred in 1826 patients (27.5%). 1372 patients (20.7%) died, 886 patients (13.3%) needed respiratory support, and 53 patients (0.8%) received extracorporeal membrane oxygenation. 34 of these patients survived (64.2%). The multivariable model demonstrated that pre-existing oral anticoagulation therapy with either vitamin-K antagonists OR 0.57 (95% CI 0.40-0.83, p = 0.003) or direct oral anticoagulants OR 0.71 (95% CI 0.56-0.91, p = 0.007)-but not with antiplatelet therapy alone OR 1.10 (95% CI 0.88-1.23, p = 0.66)-was associated with a lower event rate. This finding was confirmed in a propensity match analysis.
Conclusions
In a multivariable analysis, a therapy with both direct oral anticoagulants or vitamin-K antagonists-but not with antiplatelet therapy-was associated with improved clinical outcomes. ACE inhibitors did not impact outcomes. Prospective randomized trials are needed to verify this hypothesis.



Clin Res Cardiol: 07 Jan 2021; epub ahead of print
Fröhlich GM, Jeschke E, Eichler U, Thiele H, ... Landmesser U, Günster C
Clin Res Cardiol: 07 Jan 2021; epub ahead of print | PMID: 33416918
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Impact:
Abstract

Estimated plasma volume status in heart failure: clinical implications and future directions.

Kobayashi M, Girerd N, Duarte K, Chouihed T, ... Zannad F, Rossignol P
Congestion is one of the main predictors of poor outcome in patients with heart failure (HF). Assessing and monitoring congestion is essential for optimizing HF therapy. Among the various available methods, serial measurements of estimated plasma volume (ePVS) using routine blood count and/or body weight (e.g., the Strauss, Duarte, Hakim formulas) may be useful in HF management. Further prospective study is warranted to determine whether ePVS can help optimize decongestion therapy (loop diuretics, mineralocorticoid receptor antagonists, SGLT2i) in various HF settings. This narrative review summarizes the recent evidence supporting the association of ePVS with clinical congestion and outcome(s) and discusses future directions for monitoring ePVS in HF.



Clin Res Cardiol: 05 Jan 2021; epub ahead of print
Kobayashi M, Girerd N, Duarte K, Chouihed T, ... Zannad F, Rossignol P
Clin Res Cardiol: 05 Jan 2021; epub ahead of print | PMID: 33409701
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Impact:
Abstract

Effect of frailty on treatment, hospitalisation and death in patients with chronic heart failure.

Sze S, Pellicori P, Zhang J, Weston J, Squire IB, Clark AL
Background
Frailty is common in patients with chronic heart failure (CHF) and is associated with poor outcomes. The natural history of frail patients with CHF is unknown.
Methods
Frailty was assessed using the clinical frailty scale (CFS) in 467 consecutive patients with CHF (67% male, median age 76 years, median NT-proBNP 1156 ng/L) attending a routine follow-up visit. Those with CFS > 4 were classified as frail. We investigated the relation between frailty and treatments, hospitalisation and death in patients with CHF.
Results
206 patients (44%) were frail. Of 291 patients with HF with reduced ejection fraction (HeFREF), those who were frail (N = 117; 40%) were less likely to receive optimal treatment, with many not receiving a renin-angiotensin-aldosterone system inhibitor (frail: 25% vs. non-frail: 4%), a beta-blocker (16% vs. 8%) or a mineralocorticoid receptor antagonist (50% vs 41%). By 1 year, there were 56 deaths and 322 hospitalisations, of which 25 (45%) and 198 (61%), respectively, were due to non-cardiovascular (non-CV) causes. Most deaths (N = 46, 82%) and hospitalisations (N = 215, 67%) occurred in frail patients. Amongst frail patients, 43% of deaths and 64% of hospitalisations were for non-CV causes; 58% of cardiovascular (CV) deaths were due to advancing HF. Among non-frail patients, 50% of deaths and 57% of hospitalisations were for non-CV causes; all CV deaths were due to advancing HF.
Conclusion
Frailty in patients with HeFREF is associated with sub-optimal medical treatment. Frail patients are more likely to die or be admitted to hospital, but whether frail or not, many events are non-CV.



Clin Res Cardiol: 04 Jan 2021; epub ahead of print
Sze S, Pellicori P, Zhang J, Weston J, Squire IB, Clark AL
Clin Res Cardiol: 04 Jan 2021; epub ahead of print | PMID: 33399955
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Impact:
Abstract

Energy intake during hospital stay predicts all-cause mortality after discharge independently of nutritional status in elderly heart failure patients.

Katano S, Yano T, Kouzu H, Ohori K, ... Katayose M, Miura T
Objective
Malnutrition is associated with an increased risk of mortality in heart failure (HF) patients. Here, we examined the hypothesis that assessment of energy intake in addition to nutritional status improves the stratification of mortality risk in elderly HF patients.
Methods
We retrospectively examined 419 HF patients aged ≥ 65 years (median 78 years, 49% female). Nutritional status was assessed by the Mini Nutritional Assessment Short Form (MNA-SF), and daily energy intake was calculated from intake during 3 consecutive days before discharge.
Results
During a median 1.52-year period (IQR 0.96-2.94 years), 110 patients (26%) died. Kaplan-Meier survival curves showed that patients with low tertile of daily energy intake had a higher mortality rate than did patients with high or middle tertile of daily energy intake. In multivariate Cox regression analyses, low daily energy intake was independently associated with higher mortality after adjustment for the model including age, sex, BNP, Charlson Comorbidity Index, history of HF hospitalization, and cachexia in addition to MNA-SF. Inclusion of both MNA-SF and energy intake into the adjustment model improved the accuracy of prediction of the mortality after discharge (continuous net reclassification improvement, 0.355, p = 0.003; integrated discrimination improvement, 0.029, p = 0.003). Results of a fully adjusted dose-dependent association analysis showed that risk of all-cause mortality was lowest among HF patients who consumed 31.5 kcal/kg/day of energy.
Conclusions
Energy intake during hospital stay is an independent predictor of the mortality in elderly HF patients, and its assessment together with established predictors improves the mortality risk stratification.



Clin Res Cardiol: 04 Jan 2021; epub ahead of print
Katano S, Yano T, Kouzu H, Ohori K, ... Katayose M, Miura T
Clin Res Cardiol: 04 Jan 2021; epub ahead of print | PMID: 33399954
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Impact:
Abstract

Guideline-directed medical therapy in real-world heart failure patients with low blood pressure and renal dysfunction.

Chen X, Cui X, Thunström E, Pivodic A, Dahlström U, Fu M
Background
Among patients with heart failure and reduced ejection fraction (HFrEF), angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEI/ARB), β-blockers (BB) and mineralocorticoid receptor antagonist (MRA) are known as guideline-directed medical therapy to improve prognosis. However, low blood pressure (BP) and renal dysfunction are often challenges prevent clinical implementation, so we investigated the association of different combinations of GDMT treatments with all-cause mortality in HFrEF population with low BP and renal dysfunction.
Methods
This study initially included 51, 060 HF patients from the Swedish Heart Failure Registry, and finally 1464 HFrEF patients with low BP (systolic BP ≦ 100 mmHg) and renal dysfunction (estimated glomerular filtration rate (eGFR) ≦ 60 ml/min/1.73m2) were ultimately enrolled. Patients were receiving oral medication for HF at study enrollment, and divided into four groups (group 1-4: ACEI/ARB + BB + MRA, ACEI/ARB + BB, ACEI/ARB + MRA or ACEI/ARB only, and other). The outcome is time to all-cause mortality.
Results
Among the study patients, 485 (33.1%), 672 (45.9%), 109 (7.4%) and 198 (13.5%) patients were in group 1-4. Patients in group 1 were younger, had highest hemoglobin, and most with EF < 30%. During a median of 1.33 years follow-up, 937 (64%) patients died. After adjustment for age, gender, LVEF, eGFR, hemoglobin when compared with the group 1, the hazard ratio for all-cause mortality in group 2 was 1.04 (0.89-1.21) (p = 0.62), group 3 1.40 (1.09-1.79) (p = 0.009), and group 4 1.71 (1.39-2.09) (p < 0.001).
Conclusions
In real-world HFrEF patients with low BP and renal dysfunction, full medication of guideline-directed medical therapy is associated with improved survival. The benefit was larger close to the index date and decreased with follow-up time.



Clin Res Cardiol: 03 Jan 2021; epub ahead of print
Chen X, Cui X, Thunström E, Pivodic A, Dahlström U, Fu M
Clin Res Cardiol: 03 Jan 2021; epub ahead of print | PMID: 33394127
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Impact:
Abstract

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

Bugani G, Pagnesi M, Tchetchè D, Kim WK, ... Colombo A, Mangieri A
Objectives
To define the incidence of high residual gradient (HRG) after transcatheter aortic valve replacement (TAVR) in BAVs and their impact on short term outcome and 1-year mortality.
Background
Transcatheter heart valves (THVs) offer good performance in tricuspid aortic valves with low rate of HRG. However, data regarding their performance in bicuspid aortic valves (BAV) are still lacking.
Methods
The BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry included 353 consecutive patients who underwent TAVR (Evolut R/PRO or Sapien 3 valves) in BAV between June 2013 and October 2018. The primary endpoint was device unsuccess with post-procedural HRG (mean gradient ≥ 20 mmHg). The secondary endpoint was to identify the predictors of HRG following the procedure.
Results
Twenty patients (5.6%) showed HRG after TAVR. Patients with HRG presented higher body mass index (BMI) (30.7 ± 9.3 vs. 25.9 ± 4.8; p < 0.0001) and higher baseline aortic mean gradients (57.6 ± 13.4 mmHg vs. 47.7 ± 16.6, p = 0.013) and more often presented with BAV of Sievers type 0 than patients without HRG. At multivariate analysis, BMI [odds ratio (OR) 1.12; 95% confidence interval (CI) 1.05-1.20, p = 0.001] and BAV type 0 (OR 11.31, 95% CI 3.45-37.06, p < 0.0001) were confirmed as independent predictors of high gradient.
Conclusion
HRG following TAVR in BAVs is not negligible and is higher among patients with high BMI and with BAV 0 anatomy.



Clin Res Cardiol: 02 Jan 2021; epub ahead of print
Bugani G, Pagnesi M, Tchetchè D, Kim WK, ... Colombo A, Mangieri A
Clin Res Cardiol: 02 Jan 2021; epub ahead of print | PMID: 33389062
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Impact:
Abstract

Midregional pro atrial natriuretic peptide: a novel important biomarker for noise annoyance-induced cardiovascular morbidity and mortality?

Hahad O, Wild PS, Prochaska JH, Schulz A, ... Daiber A, Münzel T
Background
Environmental noise exposure has been associated with increased cardiovascular morbidity and mortality. Recently, noise annoyance was shown to induce atrial fibrillation, which was accompanied by significantly increased levels of midregional pro atrial natriuretic peptide (MR-proANP). Therefore, the aim of the present study was to analyze the association between noise annoyance, MR-proANP, incident cardiovascular events, and all-cause mortality.
Methods
Levels of MR-proANP were measured in the first 5000 participants of the population-based Gutenberg Health Study. Annoyance was assessed separately for aircraft, road traffic, railway, neighborhood, and industrial/construction noise during the day and sleep.
Results
In cross-sectional analyses, aircraft noise annoyance during day and sleep, industrial/construction noise annoyance during day, and railway noise annoyance during sleep were independently associated with increased levels of MR-proANP after multivariable adjustment. After a 5-year follow-up period, there were 43 cases of incident atrial fibrillation and 103 of incident cardiovascular disease (comprising atrial fibrillation, coronary artery disease, myocardial infarction, heart failure, or stroke). Moreover, there were 301 deaths after a mean follow-up of 7.42 ± 1.66 years. An odds ratio (OR) of 2.82 ([95% confidence interval (CI) 1.86; 4.35], p < 0.0001) for incident atrial fibrillation and an OR of 1.49 ([95% CI 1.13; 1.96], p = 0.0046) for incident cardiovascular disease per 1-standard deviation (SD) increase in MR-proANP levels were found. A 36% (hazard ratio: 1.36 [95% CI 1.19; 1.55], p < 0.0001) higher risk of death was found per 1-SD increase in MR-proANP levels.
Conclusions
Noise annoyance may contribute to cardiovascular morbidity and mortality and is characterized by increased levels of MR-proANP.



Clin Res Cardiol: 30 Dec 2020; 110:29-39
Hahad O, Wild PS, Prochaska JH, Schulz A, ... Daiber A, Münzel T
Clin Res Cardiol: 30 Dec 2020; 110:29-39 | PMID: 32306084
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Impact:
Abstract

Left atrial appendage closure in patients with chronic kidney disease: results from the German multicentre LAARGE registry.

Fastner C, Brachmann J, Lewalter T, Zeymer U, ... Senges J, Akin I
Objectives
Chronic kidney disease (CKD) is associated with an increased complication rate after cardiac interventions. Although CKD has a high prevalence among atrial fibrillation patients, the impact of CKD on periprocedural complications and the outcome after an interventional left atrial appendage closure (LAAC) is unclear. The present study, therefore, aimed to investigate whether CKD influences the procedure\'s effectiveness and safety.
Methods
LAARGE is a prospective, non-randomised registry. LAAC was conducted with different standard commercial devices, and the follow-up period was one year. CKD was defined by an eGFR < 60 mL/min/1.73 m2, and subgroups were further analysed (i.e. eGFR < 15, 15-29, and 30-59 mL/min/1.73 m2, respectively).
Results
Two hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHA2DS2-VASc score (4.9 vs. 4.2), and HAS-BLED score (4.3 vs. 3.5) was significantly higher in CKD patients (each p < 0.001). Implantation success was similarly high across all GFR groups (97.9%). Periprocedural MACCE (0.7 vs. 0.3%), and other major complications (4.7 vs. 3.7%) were comparably infrequent. Survival free of stroke was significantly lower among CKD patients within 1 year (82.0 vs. 93.0%; p < 0.001; consistent after adjustment for confounding factors), without significant accentuation in advanced CKD (i.e. eGFR < 30 mL/min/1.73 m2; p > 0.05  vs. eGFR 30-59 mL/min/1.73 m2). Non-fatal strokes were absolutely infrequent during follow-up (0 vs. 1.1%). Severe non-fatal bleedings were observed only among CKD patients (1.4 vs. 0%; p = 0.021).
Conclusions
Despite an increased cardiovascular risk profile of CKD patients, device implantation was safe, and LAAC was associated with effective stroke prevention across all CKD stages.



Clin Res Cardiol: 30 Dec 2020; 110:12-20
Fastner C, Brachmann J, Lewalter T, Zeymer U, ... Senges J, Akin I
Clin Res Cardiol: 30 Dec 2020; 110:12-20 | PMID: 32296971
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Impact:
Abstract

Re-introducing immunotherapy in patients surviving immune checkpoint inhibitors-mediated myocarditis.

Peleg Hasson S, Salwen B, Sivan A, Shamai S, ... Wolf I, Laufer-Perl M
Background
Immune checkpoint inhibitors (ICI) have transformed the standard care of cancer treatment. Recent case reports describe ICI-mediated myocarditis with an atypical presentation and fatal potential which lead to permanent interruption of immunotherapy.
Objectives
To characterize ICI-mediated myocarditis and re-introduction to immunotherapy.
Methods
During 2019, 849 patients were treated with ICI at Tel Aviv Sourasky Medical Center for the diagnosis of lung adenocarcinoma, gastric adenocarcinoma, urothelial carcinoma, and hepatocellular carcinoma. Overall, seven (0.8%) patients were diagnosed with ICI-mediated myocarditis, according to the European Society of Cardiology guidelines of myocarditis 2013. We retrospectively evaluated their presentation, severity, and clinical outcomes.
Results
Among the seven patients, only one had a history of cardiac disease. The majority were diagnosed with lung adenocarcinoma and treated with anti-programmed death-1 antibody. All patients were treated with single-agent ICI. Most patients presented with cardiac symptoms, elevated troponin and typical cardiac magnetic resonance; however, only three had reduced ejection fraction. Overall, three patients were chosen for re-introduction with concomitant low dose steroids and weekly troponin follow-up. Two patients diagnosed with grade I and II renewed therapy successfully with no recurrence of symptoms and improvement in disease burden. The one patient diagnosed with grade III developed worsening of cardiac symptoms after the 1st cycle and, therefore, therapy was interrupted permanently.
Conclusions
ICI-mediated myocarditis is potentially fatal and leads to permanent interruption of life-saving cancer therapy. The current data suggest that re-introduction may be considered in low-grade patients; however, a better definition of the diagnosis and grading is needed.



Clin Res Cardiol: 30 Dec 2020; 110:50-60
Peleg Hasson S, Salwen B, Sivan A, Shamai S, ... Wolf I, Laufer-Perl M
Clin Res Cardiol: 30 Dec 2020; 110:50-60 | PMID: 32296970
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Impact:
Abstract

Global longitudinal strain by feature tracking for optimized prediction of adverse remodeling after ST-elevation myocardial infarction.

Reindl M, Tiller C, Holzknecht M, Lechner I, ... Metzler B, Reinstadler SJ
Background
The role of left ventricular (LV) myocardial strain by cardiac magnetic resonance feature tracking (CMR-FT) for the prediction of adverse remodeling following ST-elevation myocardial infarction (STEMI), as well as its prognostic validity compared to LV ejection fraction (LVEF) and CMR infarct severity parameters, is unclear. This study aimed to evaluate the independent and incremental value of LV strain by CMR-FT for the prediction of adverse LV remodeling post-STEMI.
Methods
STEMI patients treated with primary percutaneous coronary intervention were enrolled in this prospective observational study. CMR core laboratory analysis was performed to assess LVEF, infarct pathology and LV myocardial strain. The primary endpoint was adverse remodeling, defined as ≥ 20% increase in LV end-diastolic volume from baseline to 4 months.
Results
From the 232 patients included, 38 (16.4%) reached the primary endpoint. Global longitudinal strain (GLS), global radial strain, and global circumferential strain were all predictive of adverse remodeling (p < 0.01 for all), but only GLS was an independent predictor of adverse remodeling (odds ratio: 1.36[1.03-1.78]; p = 0.028) after adjustment for strain parameters, LVEF and CMR markers of infarct severity. A GLS > - 14% was associated with a fourfold increase in the risk for LV remodeling (odds ratio: 4.16[1.56-11.13]; p = 0.005). Addition of GLS to a baseline model comprising LVEF, infarct size and microvascular obstruction resulted in net reclassification improvement of 0.26 ([0.13-0.38]; p < 0.001) and integrated discrimination improvement of 0.02 ([0.01-0.03]; p = 0.006).
Conclusions
In STEMI survivors, determination of GLS using CMR-FT provides important prognostic information for the development of adverse remodeling that is incremental to LVEF and CMR markers of infarct severity.
Clinical trial registration
NCT04113356.



Clin Res Cardiol: 30 Dec 2020; 110:61-71
Reindl M, Tiller C, Holzknecht M, Lechner I, ... Metzler B, Reinstadler SJ
Clin Res Cardiol: 30 Dec 2020; 110:61-71 | PMID: 32296969
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Impact:
Abstract

Analysis of length of stay after transfemoral transcatheter aortic valve replacement: results from the FRANCE TAVI registry.

Durand E, Avinée G, Gillibert A, Tron C, ... Le Breton H, Eltchaninoff H
Background
Currently, there are no recommendations regarding the minimum duration of in-hospital monitoring after transfemoral (TF) transcatheter aortic valve replacement (TAVR) and practices are extremely heterogeneous. We, therefore, aimed to evaluate length of stay (LOS) and predictive factors for late discharge after TF TAVR using data from the FRANCE TAVI registry.
Methods
TAVR was performed in 12,804 patients in 48 French centers between 2013 and 2015. LOS was evaluated in 5857 TF patients discharged home. LOS was calculated from TAVR procedure (day 0) to discharge. The study population was divided into three groups based on LOS values. Patients discharged within 3 days constituted the \"very early\" discharge group, patients with a LOS between 3 and 6 days constituted the \"early\" discharge group, and patients with a length of stay > 6 days constituted the \"late\" discharge group.
Results
The median LOS was 7 (5-9) days and was extremely variable among centers. The proportion of patients discharged very early, early, and late was 4.4% (n = 256), 33.7% (n = 1997), and 61.9% (n = 3624) respectively. Variables associated with late discharge were female sex, co-morbidities, major complications, self-expandable valve, general anesthesia, and a significant center effect. In contrast, history of previous pacemaker was a protective factor. The composite of death and re-admission in the very early and early versus late discharge groups was similar at 30 days (3.3% vs. 3.5%, p = 0.66).
Conclusions
LOS is extremely variable after TF TAVR in France. Co-morbidities and complications were predictive factors of late discharge after TAVI. Interestingly, the use of self-expandable prosthesis and general anesthesia may also contribute to late discharge. Our results confirm that early discharge is safe.



Clin Res Cardiol: 30 Dec 2020; 110:40-49
Durand E, Avinée G, Gillibert A, Tron C, ... Le Breton H, Eltchaninoff H
Clin Res Cardiol: 30 Dec 2020; 110:40-49 | PMID: 32335689
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Impact:
Abstract

Hypothermia in patients with acute myocardial infarction: a meta-analysis of randomized trials.

Alushi B, Ndrepepa G, Lauten A, Lahmann AL, ... Kastrati A, Cassese S
Background
In patients with acute myocardial infarction (MI) receiving percutaneous coronary intervention (PCI), the role of systemic therapeutic hypothermia remains controversial. We sought to investigate the role of systemic therapeutic hypothermia versus standard of care in patients with acute MI treated with PCI.
Methods
This is a study-level meta-analysis of randomized trials. The primary outcome was all-cause death. The main secondary outcome was infarct size. Other secondary outcomes were recurrent MI, ischemia-driven target vessel revascularization (TVR), major adverse cardiovascular events, and bleeding.
Results
A total of 1012 patients with acute MI receiving a PCI in nine trials (503 randomly assigned to hypothermia and 509 to control) were available for the quantitative synthesis. The weighted median follow-up was 30 days. As compared to controls, patients assigned to hypothermia had similar risk of all-cause death (risk ratio, [95% confidence intervals], 1.25 [0.80; 1.95], p = 0.32), with a trend toward higher risk of ischemia-driven TVR (3.55 [0.80; 15.87], p = 0.09) mostly due to acute or subacute stent thrombosis. Although in the overall cohort, infarct size was comparable between groups (standardized mean difference [95% Confidence intervals], 0.06 [- 0.92; 1.04], p = 0.92), patients effectively achieving the protocol-defined target temperature in the hypothermia group had smaller infarct size as compared to controls (p for interaction = 0.016). Treatment strategies did not differ with respect to the other outcomes.
Conclusions
As compared to standard of care, systemic therapeutic hypothermia in acute MI patients treated with PCI provided similar mortality with a signal toward more frequent repeat revascularization. Among patients assigned to hypothermia, those effectively achieving the protocol-defined target temperature displayed smaller infarct size.
Trial registration
PROSPERO, CRD42019138754.



Clin Res Cardiol: 30 Dec 2020; 110:84-92
Alushi B, Ndrepepa G, Lauten A, Lahmann AL, ... Kastrati A, Cassese S
Clin Res Cardiol: 30 Dec 2020; 110:84-92 | PMID: 32303830
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Impact:
Abstract

Clinical outcomes and thrombus resolution in patients with solid left atrial appendage thrombi: results of a single-center real-world registry.

Nelles D, Lambers M, Schafigh M, Morais P, ... Hammerstingl C, Sedaghat A
Background
Data on thrombus resolution and clinical outcome data after a therapy of LAA thrombus with novel oral anticoagulants (NOACs) are scarce.
Methods
In this single-center study, we retrospectively analyzed 78 patients diagnosed with a solid LAA thrombus by transesophageal echocardiography (TEE). We assessed baseline clinical and echocardiographic characteristics, the anticoagulatory regimens and outcomes of patients with (responders) and without (non-responders) thrombus resolution.
Results
Mean age was 76.1 ± 8.3 years, patients were male in 57.7% and presented with a high risk for thromboembolism (CHA2DS2-VASc: 4.3 ± 1.1). At thrombus diagnosis, 44.9% patients were treated with a NOAC, while 41.0% were under therapy with a VKA. Complete thrombus resolution was achieved after a mean of 116 ± 79 days in a total of 51.3% of patients, 35.9% showed a reduction of thrombus size, whereas 12.8% showed no changes in thrombus dimensions. There was no statistically significant difference in the rate of LAA thrombus resolution between VKA and NOACs (41.2 vs. 57.1%, p = 0.18). However, in cases in which only the therapy with a NOAC led to complete thrombus resolution, the time needed was significantly shorter than with VKA (81 ± 38 vs. 129 ± 46 days, p = 0.03). Regarding safety outcomes, no differences in bleeding or thromboembolism were observed between patients with and without thrombus resolution.
Conclusions
In this registry, approximately 85% of LAA thrombi were diagnosed in patients with ongoing OAC. Thrombus resolution was observed in nearly 50% of cases. Although there was no difference in the rate of LAA thrombus resolution between VKA and NOACs, the resolution time was shorter in patients prescribed a NOAC.



Clin Res Cardiol: 30 Dec 2020; 110:72-83
Nelles D, Lambers M, Schafigh M, Morais P, ... Hammerstingl C, Sedaghat A
Clin Res Cardiol: 30 Dec 2020; 110:72-83 | PMID: 32307589
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Impact:
Abstract

Cardiac sympathetic denervation in patients with nonischemic cardiomyopathy and refractory ventricular arrhythmias: a single-center experience.

Yalin K, Liosis S, Palade E, Fink T, ... Vogler J, Tilz RR
Introduction
Cardiac sympathetic denervation (CSD) is an effective therapy for selected patients with drug refractory ventricular arrhythmias (VA). Data about the role of CSD in patients with structural heart disease and VAs are sparse. We herein present our experience of CSD in patients with nonischemic cardiomyopathy and VAs despite prior ablation procedure and/or antiarrhythmic drug (AAD) therapy.
Methods
A total of ten patients (mean age 61.6 ± 19.6, mean LVEF 29.5 ± 12.1%) with nonischemic dilated cardiomyopathy (NICM) (n = 9) and hypertrophic cardiomyopathy (HCM) (n = 1) underwent CSD (left sided in six and bilateral in four patients) due to refractory VA despite multiple AADs (mean number of AADs was 1.6 ± 0.7) and prior VT ablation (mean number of procedures per patient was 1.5 ± 1.3).
Results
Mean follow-up was 10.1 ± 6.9 months. The median number of VA and ICD shocks decreased significantly from 9.0 and 2.5 episodes 6 months prior to CSD to 0 and 0 episodes within 6 months after CSD (p = 0.012 and p = 0.011). Five patients remained free from sustained VA recurrences. Two patients experienced single ICD shock due to a polymorphic VT (triggered by severe hypokalemia in one patient) and one patient a single shock due to monomorphic VT. One patient had five episodes of slow VT under amiodarone therapy (three of them terminated by antitachycardia pacing) and underwent endo- epicardial re-ablation. Two patients died 1 month after CSD. One of them due to electrical storm and cardiogenic shock and the second one due to refractory cardiogenic shock, without recurrence of VAs though. No major complications of CSD occurred. No patient suffered from Horner syndrome.
Conclusion
In this study, CSD was effective for treatment of VAs in patients with structural heart disease refractory to antiarrhythmic drugs and catheter ablation. Further larger studies are required to confirm these findings.



Clin Res Cardiol: 30 Dec 2020; 110:21-28
Yalin K, Liosis S, Palade E, Fink T, ... Vogler J, Tilz RR
Clin Res Cardiol: 30 Dec 2020; 110:21-28 | PMID: 32328735
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Impact:
Abstract

Diagnostic value of the novel CMR parameter \"myocardial transit-time\" (MyoTT) for the assessment of microvascular changes in cardiac amyloidosis and hypertrophic cardiomyopathy.

Chatzantonis G, Bietenbeck M, Florian A, Meier C, ... Reinecke H, Yilmaz A
Background
Coronary microvascular dysfunction (CMD) is present in various non-ischemic cardiomyopathies and in particular in those with left-ventricular hypertrophy. This study evaluated the diagnostic value of the novel cardiovascular magnetic resonance (CMR) parameter \"myocardial transit-time\" (MyoTT) in distinguishing cardiac amyloidosis from other hypertrophic cardiomyopathies.
Methods
N = 20 patients with biopsy-proven cardiac amyloidosis (CA), N = 20 patients with known hypertrophic cardiomyopathy (HCM), and N = 20 control patients without relevant cardiac disease underwent dedicated CMR studies on a 1.5-T MR scanner. The CMR protocol comprised cine and late-gadolinium-enhancement (LGE) imaging as well as first-pass perfusion acquisitions at rest for MyoTT measurement. MyoTT was defined as the blood circulation time from the orifice of the coronary arteries to the pooling in the coronary sinus (CS) reflecting the transit-time of gadolinium in the myocardial microvasculature.
Results
MyoTT was significantly prolonged in patients with CA compared to both groups: 14.8 ± 4.1 s in CA vs. 12.2 ± 2.5 s in HCM (p = 0.043) vs. 7.2 ± 2.6 s in controls (p < 0.001). Native T1 and extracellular volume (ECV) were significantly higher in CA compared to HCM and controls (p < 0.001). Both parameters were associated with a higher diagnostic accuracy in predicting the presence of CA compared to MyoTT: area under the curve (AUC) for native T1 = 0.93 (95% confidence interval (CI) = 0.83-1.00; p < 0.001) and AUC for ECV = 0.95 (95% CI = 0.88-1.00; p < 0.001)-compared to the AUC for MyoTT = 0.76 (95% CI = 0.60-0.92; p = 0.008). In contrast, MyoTT performed better than all other CMR parameters in differentiating HCM from controls (AUC for MyoTT = 0.93; 95% CI = 0.81-1.00; p = 0.003 vs. AUC for native T1 = 0.69; 95% CI = 0.44-0.93; p = 0.20 vs. AUC for ECV = 0.85; 95% CI = 0.66-1.00; p = 0.017).
Conclusion
The relative severity of CMD (measured by MyoTT) in relationship to extracellular changes (measured by native T1 and/or ECV) is more pronounced in HCM compared to CA-in spite of a higher absolute MyoTT value in CA patients. Hence, MyoTT may improve our understanding of the interplay between extracellular/intracellular and intravasal changes that occur in the myocardium during the disease course of different cardiomyopathies.



Clin Res Cardiol: 30 Dec 2020; 110:136-145
Chatzantonis G, Bietenbeck M, Florian A, Meier C, ... Reinecke H, Yilmaz A
Clin Res Cardiol: 30 Dec 2020; 110:136-145 | PMID: 32372287
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Impact:
Abstract

Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry.

Veltmann C, Winter S, Duncker D, Jungbauer CG, ... Kutyifa V, Klein HU
Background
The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death.
Methods and results
781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown.
Conclusions
Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation.



Clin Res Cardiol: 30 Dec 2020; 110:102-113
Veltmann C, Winter S, Duncker D, Jungbauer CG, ... Kutyifa V, Klein HU
Clin Res Cardiol: 30 Dec 2020; 110:102-113 | PMID: 32377784
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Impact:
Abstract

Noncalcified plaque burden quantified from coronary computed tomography angiography improves prediction of side branch occlusion after main vessel stenting in bifurcation lesions: results from the CT-PRECISION registry.

Grodecki K, Cadet S, Staruch AD, Michalowska AM, ... Dey D, Opolski MP
Objectives
To assess the incremental value of quantitative plaque features measured from computed tomography angiography (CTA) for predicting side branch (SB) occlusion in coronary bifurcation intervention.
Methods
We included 340 patients with 377 bifurcation lesions in the post hoc analysis of the CT-PRECISION registry. Each bifurcation was divided into three segments: the proximal main vessel (MV), the distal MV, and the SB. Segments with evidence of coronary plaque were analyzed using semi-automated software allowing for quantitative analysis of coronary plaque morphology and stenosis. Coronary plaque measurements included calcified and noncalcified plaque volumes, and corresponding burdens (respective plaque volumes × 100%/vessel volume), remodeling index, and stenosis.
Results
SB occlusion occurred in 28 of 377 bifurcation lesions (7.5%). The presence of visually identified plaque in the SB segment, but not in the proximal and distal MV segments, was the only qualitative parameter that predicted SB occlusion with an area under the curve (AUC) of 0.792. Among quantitative plaque parameters calculated for the SB segment, the addition of noncalcified plaque burden (AUC 0.840, p = 0.003) and low-density plaque burden (AUC 0.836, p = 0.012) yielded significant improvements in predicting SB occlusion. Using receiver operating characteristic curve analysis, optimal cut-offs for noncalcified plaque burden and low-density plaque burden were > 33.6% (86% sensitivity and 78% specificity) and > 0.9% (89% sensitivity and 73% specificity), respectively.
Conclusions
CTA-derived noncalcified plaque burden, when added to the visually identified SB plaque, significantly improves the prediction of SB occlusion in coronary bifurcation intervention.
Trial registration
ClinicalTrials.gov Identifier: NCT03709836 registered on October 17, 2018.



Clin Res Cardiol: 30 Dec 2020; 110:114-123
Grodecki K, Cadet S, Staruch AD, Michalowska AM, ... Dey D, Opolski MP
Clin Res Cardiol: 30 Dec 2020; 110:114-123 | PMID: 32385529
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Impact:
Abstract

Predictors for low TAVI-prosthesis position assessed by fusion imaging of pre- and post-procedural CT angiography.

Breitbart P, Pache G, Minners J, Hein M, ... Neumann FJ, Ruile P
Background
Low prosthesis position after transcatheter aortic valve implantation (TAVI) is associated with higher rates of new onset conduction disturbances and permanent pacemaker implantations. Purpose of this study was to investigate possible predictors of a low prosthesis position of the SAPIEN 3 (Edwards Lifesciences, Irvine, California, USA) valve type using fusion imaging of pre- and post-procedural computed tomography angiography (CTA).
Methods
CTA fusion imaging was performed in 120 TAVI-patients with 3D-reconstruction of the transcatheter heart valve (THV) position within the device landing zone. A low implantation position was defined according to the manufacturer\'s recommendations as > 30% of the prosthesis below the native annulus plane.
Results
A low THV position was found in 17 patients (14%). Patients with low THV position had less calcification of the annulus region and a smaller annulus size compared to patients with a normal or high THV position (P = 0.003 and 0.041, respectively). The only independent predictor of a low THV position in multivariate logistic regression analysis was the extent of calcification of the cusp region (odds ratio [CI] 0.842 [0.727-0.976], P = 0.022).
Conclusions
Fusion imaging of pre-and post-procedural CTA identified reduced calcification of the cusp region as an independent predictor of a low THV position of the SAPIEN 3. This should be considered when planning the TAVI procedure. Correlation of cusp region calcification and prosthesis position after TAVI.



Clin Res Cardiol: 30 Dec 2020; 110:93-101
Breitbart P, Pache G, Minners J, Hein M, ... Neumann FJ, Ruile P
Clin Res Cardiol: 30 Dec 2020; 110:93-101 | PMID: 32399896
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Impact:
Abstract

Cryoballoon pulmonary vein isolation-mediated rise of sinus rate in patients with paroxysmal atrial fibrillation.

Wagner L, Darche FF, Thomas D, Lugenbiel P, ... Katus HA, Schweizer PA
Background
Modulation of the cardiac autonomic nervous system by pulmonary vein isolation (PVI) influences the sinoatrial nodal rate. Little is known about the causes, maintenance and prognostic value of this phenomenon. We set out to explore the effects of cryoballoon PVI (cryo-PVI) on sinus rate and its significance for clinical outcome.
Methods and results
We evaluated 110 patients with paroxysmal atrial fibrillation (AF), who underwent PVI using a second-generation 28 mm cryoballoon by pre-, peri- and postprocedural heart rate acquisition and analysis of clinical outcome. Ninety-one patients could be included in postinterventional follow-up, indicating that cryo-PVI resulted in a significant rise of sinus rate by 16.5% (+ 9.8 ± 0.9 beats/min, p < 0.001) 1 day post procedure compared to preprocedural acquisition. This effect was more pronounced in patients with initial sinus bradycardia (< 60 beats/min.) compared to patients with faster heart rate. Increase of rate was primarily driven by ablation of the right superior pulmonary vein and for a subset of patients, in whom this could be assessed, persisted ≥ 1 year after the procedure. AF recurrence was neither predicted by the magnitude of the initial rate, nor by the extent of rate change, but postprocedural sinus bradycardia was associated with higher recurrence of AF in the year post PVI.
Conclusions
Cryo-PVI causes a significant rise of sinus rate that is more pronounced in subjects with previous sinus bradycardia. Patient follow-up indicates persistence of this effect and suggests an increased risk of AF recurrence in patients with postprocedural bradycardia.



Clin Res Cardiol: 30 Dec 2020; 110:124-135
Wagner L, Darche FF, Thomas D, Lugenbiel P, ... Katus HA, Schweizer PA
Clin Res Cardiol: 30 Dec 2020; 110:124-135 | PMID: 32405738
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Impact:
Abstract

One- and 3-year outcomes of percutaneous bifurcation left main revascularization with modern drug-eluting stents: a systematic review and meta-analysis.

Rigatelli G, Zuin M, Nikolov P, Mileva N, Vassilev D
Aims
Optimal percutaneous coronary intervention (PCI) strategy for coronary left main (LM) bifurcation lesions remains controversial. We performed systematic review and meta-analysis comparing one and 3-year clinical outcomes of 1- and 2- stent strategies using modern drug eluting stents (DESs) for revascularization of LM bifurcation disease.
Methods
We systematically identified all investigations published between January 2015 and February 2020 comparing the use of single versus double-stent strategies for the revascularization of LM bifurcation lesions. The primary endpoint was 1- and 3-years all-cause mortality. Secondary outcomes included target lesion revascularization (TLR), target lesion failure (TLF), major adverse cardiovascular vents (MACEs) and cardiovascular (CV) mortality while the tertiary outcome was overall occurrence of stent thrombosis (ST) at 1- and 3-years.
Results
No significant differences were observed between the two groups in terms of all-cause mortality rate both at 1 and 3-year follow-up. Single stent strategy was associated with a significantly lower risk of TLR (OR 0.78, 95% CI 0.62- 0.97, p = 0.03, I2 = 61%) as well as of MACEs (OR 0.78, 95% CI 0.63-0.97, I2 = 24%) compared to 2-stent strategy. Conversely no significant differences between the two groups were observed in terms of TLF, CV mortality and ST during the same follow-up period.
Conclusions
In patients with LM bifurcation disease, single stent strategy demonstrated lower rate of MACEs and TLR but was not superior to 2-stent strategy in terms of CV mortality, TLF and ST at 1 and 3-year follow-up.



Clin Res Cardiol: 30 Dec 2020; 110:1-11
Rigatelli G, Zuin M, Nikolov P, Mileva N, Vassilev D
Clin Res Cardiol: 30 Dec 2020; 110:1-11 | PMID: 32474643
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Impact:
Abstract

Functional and prognostic implications of cardiac magnetic resonance feature tracking-derived remote myocardial strain analyses in patients following acute myocardial infarction.

Lange T, Stiermaier T, Backhaus SJ, Boom PC, ... Eitel I, Schuster A
Background
Cardiac magnetic resonance myocardial feature tracking (CMR-FT)-derived global strain assessments provide incremental prognostic information in patients following acute myocardial infarction (AMI). Functional analyses of the remote myocardium (RM) are scarce and whether they provide an additional prognostic value in these patients is unknown.
Methods
1034 patients following acute myocardial infarction were included. CMR imaging and strain analyses as well as infarct size quantification were performed after reperfusion by primary percutaneous coronary intervention. The occurrence of major adverse cardiac events (MACE) within 12 months after the index event was defined as primary clinical endpoint.
Results
Patients with MACE had significantly lower RM circumferential strain (CS) compared to those without MACE. A cutoff value for RM CS of - 25.8% best identified high-risk patients (p < 0.001 on log-rank testing) and impaired RM CS was a strong predictor of MACE (HR 1.05, 95% CI 1.07-1.14, p = 0.003). RM CS provided further risk stratification among patients considered at risk according to established CMR parameters for (1) patients with reduced left ventricular ejection fraction (LVEF) ≤ 35% (p = 0.038 on log-rank testing), (2) patients with reduced global circumferential strain (GCS) > -  18.3% (p = 0.015 on log-rank testing), and (3) patients with large microvascular obstruction ≥ 1.46% (p = 0.002 on log-rank testing).
Conclusion
CMR-FT-derived RM CS is a useful parameter to characterize the response of the remote myocardium and allows improved stratification following AMI beyond commonly used parameters, especially of high-risk patients.
Trial registration
ClinicalTrials.gov, NCT00712101 and NCT01612312 Defining remote segments (R) in the presence of infarct areas (I) for the analysis of remote circumferential strain (CS). Remote CS was significantly lower in patients who suffered major adverse cardiac events (MACE) and a cutoff value for remote CS of - 25.8% best identified high-risk patients. In addition, impaired remote CS ≥ - 25.8 % (Remote -) and preserved remote CS < - 25.8 % (Remote +) enabled further risk stratification when added to established parameters like left ventricular ejection fraction (LVEF), global circumferential strain (GCS) or microvascular obstruction (MVO).



Clin Res Cardiol: 30 Dec 2020; 110:270-280
Lange T, Stiermaier T, Backhaus SJ, Boom PC, ... Eitel I, Schuster A
Clin Res Cardiol: 30 Dec 2020; 110:270-280 | PMID: 33083869
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Impact:
Abstract

Antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement. A meta-analysis of randomized controlled trials.

Pellegrini C, Xhepa E, Ndrepepa G, Alvarez-Covarrubias H, ... Joner M, Cassese S
Aims
To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR).
Methods and results
This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio-RR = 0.83, 95% Confidence intervals-CI (0.57-1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61-2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27-3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke.
Conclusions
In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation.



Clin Res Cardiol: 22 Dec 2020; epub ahead of print
Pellegrini C, Xhepa E, Ndrepepa G, Alvarez-Covarrubias H, ... Joner M, Cassese S
Clin Res Cardiol: 22 Dec 2020; epub ahead of print | PMID: 33367949
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Abstract

Impact of frailty on periprocedural health care utilization in patients undergoing transcatheter edge-to-edge mitral valve repair.

Iliadis C, Schwabe L, Müller D, Stock S, Baldus S, Pfister R
Background
Frailty is a common characteristic of patients undergoing transcatheter mitral valve repair (TMVR). It is unclear whether the physical vulnerability of frail patients translates into increased procedural health care utilization.
Methods and results
Frailty was assessed using the Fried criteria in 229 patients undergoing TMVR using the MitraClip system at our institution and associations with total costs and costs by cost centers within the hospital incurred during periprocedural hospitalization were examined. Frail patients (n = 107, 47%) compared to non-frail patients showed significantly higher total costs [median/interquartile range, excluding implant costs: 7,337 € (5,911-9,814) vs 6,238 € (5,584-7,499), p = 0.001], with a difference in means of 2,317 €. Frailty was the only clinical baseline characteristic with significant association with total costs. Higher total costs in frail patients were attributable primarily to longer stay on intermediate/intensive care unit (3.8 ± 5.7 days in frail vs 2.1 ± 1.7 days in non-frail, p = 0.003), but also to costs of clinical chemistry and physiotherapy. The prolonged stay on intermediate/intensive care unit in frail patients was attributable to postprocedural complications such as bleeding, kidney injury, infections and cardiovascular instability.
Conclusion
Frailty is associated with a mean 32% increase of hospital costs in patients undergoing TMVR, which is primarily the result of a prolonged recovery and increased vulnerability to complications. These findings are valuable for a hospital\'s total cost calculation and resource allocation planning. Since frailty is regarded a potentially reversible health state, preventive interventions may help reduce costs in frail patients.



Clin Res Cardiol: 16 Dec 2020; epub ahead of print
Iliadis C, Schwabe L, Müller D, Stock S, Baldus S, Pfister R
Clin Res Cardiol: 16 Dec 2020; epub ahead of print | PMID: 33336304
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Abstract

Predictors of response to cardiac resynchronization therapy in patients with chronic right ventricular pacing.

Rath B, Willy K, Wolfes J, Ellermann C, ... Eckardt L, Frommeyer G
Background
The benefits of de novo cardiac resynchronization therapy (CRT) in patients with QRS-prolongation and impaired left-ventricular function (LVEF) are well established. Current guidelines also recommend CRT-upgrade in patients requiring permanent or frequent right ventricular pacing (RVP) with symptomatic heart failure and reduced LVEF. Whereas several predictors of response to de novo CRT-implantation such as female gender, QRS-duration, non-ischemic cardiomyopathy (NICM) are known due to large prospective trials, similar factors regarding CRT-upgrade are currently lacking.
Methods and results
We examine 114 patients 3-6 months after CRT-upgrade due to frequent RVP (> 50%) and symptomatic heart failure. Response to CRT was evaluated by improvement in NYHA class referring to the Minnesota Living With Heart Failure Questionnaire. Only cardiomyopathy type and use of Angiotensin-converting-enzyme (ACE) inhibitor had an impact on response to CRT-upgrade in a linear regression model. Patients with NICM presented a greater responder rate than patients with ischemic cardiomyopathy (ICM) (80.4 vs. 60.3%, p < 0.05). Other traditional response predictors in de novo CRT recipients (e.g. QRS-width, female gender) showed no effect on CRT-response in this cohort.
Conclusion
Only underlying heart disease (NICM vs. ICM) and the use of ACE inhibitor were significant predictors of response to CRT-upgrade. In contrast to de novo CRT-recipients, where pre-implant QRS-duration is a key predictor, QRS-duration during RV-pacing has no significant impact on CRT-response in this cohort.



Clin Res Cardiol: 14 Dec 2020; epub ahead of print
Rath B, Willy K, Wolfes J, Ellermann C, ... Eckardt L, Frommeyer G
Clin Res Cardiol: 14 Dec 2020; epub ahead of print | PMID: 33320290
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Abstract

Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction.

Shen L, Jhund PS, Anand IS, Carson PE, ... Zile MR, McMurray JJV
Background
Sudden death (SD) and pump failure death (PFD) are leading modes of death in heart failure and preserved ejection fraction (HFpEF). Risk stratification for mode-specific death may aid in patient enrichment for new device trials in HFpEF.
Methods
Models were derived in 4116 patients in the Irbesartan in Heart Failure with Preserved Ejection Fraction trial (I-Preserve), using competing risks regression analysis. A series of models were built in a stepwise manner, and were validated in the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM)-Preserved and Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trials.
Results
The clinical model for SD included older age, men, lower LVEF, higher heart rate, history of diabetes or myocardial infarction, and HF hospitalization within previous 6 months, all of which were associated with a higher SD risk. The clinical model predicting PFD included older age, men, lower LVEF or diastolic blood pressure, higher heart rate, and history of diabetes or atrial fibrillation, all for a higher PFD risk, and dyslipidaemia for a lower risk of PFD. In each model, the observed and predicted incidences were similar in each risk subgroup, suggesting good calibration. Model discrimination was good for SD and excellent for PFD with Harrell\'s C of 0.71 (95% CI 0.68-0.75) and 0.78 (95% CI 0.75-0.82), respectively. Both models were robust in external validation. Adding ECG and biochemical parameters, model performance improved little in the derivation cohort but decreased in validation. Including NT-proBNP substantially increased discrimination of the SD model, and simplified the PFD model with marginal increase in discrimination.
Conclusions
The clinical models can predict risks for SD and PFD separately with good discrimination and calibration in HFpEF and are robust in external validation. Adding NT-proBNP further improved model performance. These models may help to identify high-risk individuals for device intervention in future trials.
Clinical trial registration
I-Preserve: ClinicalTrials.gov NCT00095238; TOPCAT: ClinicalTrials.gov NCT00094302; CHARM-Preserved: ClinicalTrials.gov NCT00634712.



Clin Res Cardiol: 09 Dec 2020; epub ahead of print
Shen L, Jhund PS, Anand IS, Carson PE, ... Zile MR, McMurray JJV
Clin Res Cardiol: 09 Dec 2020; epub ahead of print | PMID: 33301080
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Abstract

Determinants of soluble angiotensin-converting enzyme 2 concentrations in adult patients with complex congenital heart disease.

Raedle-Hurst T, Wissing S, Mackenstein N, Obeid R, ... Wagenpfeil S, Abdul-Khaliq H
Background
Angiotensin-converting enzyme (ACE) 2 is known to be a functional receptor for SARS-CoV-2 in the current pandemic. Soluble ACE2 (sACE2) concentrations are elevated in patients with various cardiovascular disorders including heart failure.
Methods
In a total of 182 consecutive adult patients with complex congenital heart disease (CHD) and 63 healthy controls, sACE2 concentrations were measured in serum using the Human ACE2® assay by Cloud-Clone Corporation and associated with clinical, laboratory and echocardiographic parameters.
Results
Median sACE2 levels were increased in patients with complex CHD as compared to healthy controls (761.9 pg/ml vs 365.2 pg/ml, p < 0.001). Moreover, sACE2 concentrations were significantly elevated in patients with a higher NYHA class ≥ III (1856.2 pg/ml vs 714.5 pg/ml in patients with NYHA class I/II, p < 0.001). Using linear regression analysis, higher sACE2 levels were associated with a higher NYHA class ≥ III, more severe CHD, a morphological left systemic ventricle, higher creatinine and the use of mineralocorticoid receptor antagonists (MRA) in the univariable model. The use of ACE inhibitors or angiotensin receptor blockers (ARB) was associated with lower sACE2 levels. In the multivariable model, higher sACE2 levels were independently associated with a higher NYHA class ≥ III (p = 0.002) and lower sACE2 levels with the use of ACE inhibitors or ARB (p = 0.001).
Conclusion
Soluble ACE2 concentrations were significantly increased in all types of complex CHD with highest levels found in patients with NYHA class ≥ III. Moreover, a higher NYHA class ≥ III was the most significant determinant that was independently associated with elevated sACE2 concentrations.



Clin Res Cardiol: 04 Dec 2020; epub ahead of print
Raedle-Hurst T, Wissing S, Mackenstein N, Obeid R, ... Wagenpfeil S, Abdul-Khaliq H
Clin Res Cardiol: 04 Dec 2020; epub ahead of print | PMID: 33280062
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This program is still in alpha version.