Journal: Clin Res Cardiol

Sorted by: date / impact
Abstract

Admission blood glucose level and outcome in patients requiring venoarterial extracorporeal membrane oxygenation.

Bemtgen X, Rilinger J, Jäckel M, Zotzmann V, ... Lother A, Staudacher DL
Background
Patients with cardiogenic shock or cardiac arrest undergoing venoarterial extracorporeal membrane oxygenation (V-A ECMO) frequently present with blood glucose levels out of normal range. The clinical relevance of such findings in the context of V-A ECMO is unknown. We therefore investigated the prognostic relevance of blood glucose at time of cannulation for V-A ECMO.
Methods
We conducted a single-center retrospective registry study. All patients receiving V-A ECMO from October 2010 to January 2020 were included if blood glucose level at time of cannulation were documented. Patients were divided in five groups according to the initial blood glucose level ranging from hypoglycemic (< 80 mg/dl), normoglycemic (80-140 mg/dl), to mild (141-240 mg/dl), moderate (241-400 mg/dl), and severe (> 400 mg/dl) hyperglycemia, respectively. Clinical presentation, arterial blood gas analysis, and survival were compared between the groups.
Results
392 patients met inclusion criteria. Median age was 62 years (51.5-70.0), SAPS II at admission was 54 (43.5-63.0), and 108/392 (27.6%) were female. 131/392 were discharged alive (hospital survival 33.4%). At time of cannulation, survivors had higher pH, hemoglobin, calcium, bicarbonate but lower potassium and lactate levels compared to non-survivors (all p < 0.01). Outcome of patients diagnosed with particularly high (> 400 mg/dl) and low (< 80 mg/dl) blood glucose at time of V-A ECMO cannulation, respectively, was worse compared to patients with normoglycemic, mildly or moderately elevated values (p = 0.02). Glucose was independently associated with poor outcome after adjustment for other predictors of survival and persisted in all investigated subgroups.
Conclusion
Arterial blood glucose at time of V-A ECMO cannulation predicts in-hospital survival of patients with cardiac shock or after ECPR. Whether dysglycemia represents a potential therapeutic target requires further evaluation in prospective studies.



Clin Res Cardiol: 03 May 2021; epub ahead of print
Bemtgen X, Rilinger J, Jäckel M, Zotzmann V, ... Lother A, Staudacher DL
Clin Res Cardiol: 03 May 2021; epub ahead of print | PMID: 33944987
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Influence of sex, age and race on coronary and heart failure events in patients with diabetes and post-acute coronary syndrome.

Rossello X, Ferreira JP, Caimari F, Lamiral Z, ... White WB, Zannad F
Background
Women, older patients and non-White ethnic groups experience a substantial proportion of acute coronary syndromes (ACS), although they have been historically underrepresented in ACS randomized clinical trials (RCTs). To assess the influence of sex, age and race on major adverse cardiovascular events (MACE) and on heart failure events, we studied patients with type 2 diabetes in a large post-ACS trial (EXAMINE).
Methods
Differences in baseline characteristics and the respective composite endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (MACE) and cardiovascular death or heart failure hospitalization (HF events) were evaluated by subgroups in a cohort of post-ACS patients with diabetes, using unadjusted and adjusted Cox regression modelling.
Results
The EXAMINE trial enrolled 5380 patients with 35% aged > 65, 32% female and 27% non-White. The risk of MACE was higher in non-White compared to White patients after adjustment for potential confounding (HR = 1.35; 95% CI 1.04-1.75), but there were no significant differences by sex and age (HR = 1.03; 95% CI 0.87-1.22 for women; HR = 1.14; 95% CI 0.96-1.35 for patients ≥ 65 years). The risk of HF events was higher in non-White patients (HR = 1.56; 95% CI 1.13-2.14), and in patients aged > 65 (HR = 1.33; 95% CI 1.07-1.66) and nominally so in women (HR = 1.23; 95% CI 0.99-1.52). The additive risk of each demographic factor (women, older age and non-White race) was greater for HF events in comparison with MACE. Moreover, non-White elderly patients consistently had poorer prognosis regardless of sex.
Conclusions
Older adults, women and non-White patients with diabetes who are post-ACS are often underrepresented in RCTs. The risk for HF events was higher in older and non-White patients, with a trend towards significance in women, whereas only non-White patients (and not women and older patients) were at higher risk for MACE. Future trials should enrich enrollment of these persons at risk.



Clin Res Cardiol: 29 Apr 2021; epub ahead of print
Rossello X, Ferreira JP, Caimari F, Lamiral Z, ... White WB, Zannad F
Clin Res Cardiol: 29 Apr 2021; epub ahead of print | PMID: 33929598
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Echocardiographic diagnosis of atrial cardiomyopathy allows outcome prediction following pulmonary vein isolation.

Eichenlaub M, Mueller-Edenborn B, Minners J, Allgeier M, ... Arentz T, Jadidi A
Background
Relevant atrial cardiomyopathy (ACM), defined as a left atrial (LA) low-voltage area ≥ 2 cm2 at 0.5 mV threshold on endocardial contact mapping, is associated with new-onset atrial fibrillation (AF), higher arrhythmia recurrence rates after pulmonary vein isolation (PVI), and an increased risk of stroke. The current study aimed to assess two non-invasive echocardiographic parameters, LA emptying fraction (EF) and LA longitudinal strain (LAS, during reservoir (LASr), conduit (LAScd) and contraction phase (LASct)) for the diagnosis of ACM and prediction of arrhythmia outcome after PVI.
Methods
We prospectively enrolled 60 consecutive, ablation-naive patients (age 66 ± 9 years, 80% males) with persistent AF. In 30 patients (derivation cohort), LA-EF and LAS cut-off values for the presence of relevant ACM (high-density endocardial contact mapping in sinus rhythm prior to PVI at 3000 ± 1249 sites) were established in sinus rhythm and tested in a validation cohort (n = 30). Arrhythmia recurrence within 12 months was documented using 72-h Holter electrocardiograms.
Results
An LA-EF of < 34% predicted ACM with an area under the curve (AUC) of 0.846 (sensitivity 69.2%, specificity 76.5%) similar to a LASr < 23.5% (AUC 0.878, sensitivity 92.3%, specificity 82.4%). In the validation cohort, these cut-offs established the correct diagnosis of ACM in 76% of patients (positive predictive values 87%/93% and negative predictive values 73%/75%, respectively). Arrhythmia recurrence in the entire cohort was significantly more frequent in patients with LA-EF < 34% and LASr < 23.5% (56% vs. 29% and 55% vs. 26%, both p < 0.05).
Conclusion
The echocardiographic parameters LA-EF and LAS allow accurate, non-invasive diagnosis of ACM and prediction of arrhythmia recurrence after PVI.



Clin Res Cardiol: 28 Apr 2021; epub ahead of print
Eichenlaub M, Mueller-Edenborn B, Minners J, Allgeier M, ... Arentz T, Jadidi A
Clin Res Cardiol: 28 Apr 2021; epub ahead of print | PMID: 33914144
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial.

Martens P, Ferreira JP, Vincent J, Abreu P, ... Zannad F, Rossignol P
Background
Sodium changes are common in myocardial infarction (MI) complicated with left ventricular systolic dysfunction (LVSD) and/or heart failure (HF). Sodium handling is fine-tuned in the distal nephron, were eplerenone exhibits some of its pleotropic effects. Little is known about the effect of eplerenone on serum sodium and the prognostic relevance of sodium alterations in patients with MI complicated with LVSD and/or HF.
Methods
The EPHESUS trial randomized 6632 patients to either eplerenone or placebo. Hyponatremia and hypernatremia were defined as sodium < 135 mmol/L or > 145 mmol/L, respectively. Linear mixed models and time updated Cox regression analysis were used to determine the effect of eplerenone on sodium changes and the prognostic importance of sodium changes, respectively. The primary outcomes were all-cause mortality and a composite of cardiovascular (CV) mortality and CV-hospitalization.
Results
A total of 6221 patients had a post-baseline sodium measurement, 797 patients developed hyponatremia (mean of 0.2 events/per patient) and 1476 developed hypernatremia (mean of 0.4 events/per patient). Patients assigned to eplerenone had a lower mean serum sodium over the follow-up (140 vs 141 mmol/L; p < 0.0001) and more often developed hyponatremia episodes (15 vs 11% p = 0.0001) and less often hypernatremia episodes (22 vs. 26% p = 0.0003). Hyponatremia, but not hypernatremia was associated with adverse outcome for all outcome endpoints in the placebo group but not in the eplerenone group (interaction p value < 0.05 for all). Baseline sodium values did not influence the treatment effect of eplerenone in reducing the various endpoints (interaction p value > 0.05 for all). Development of new-onset hyponatremia following eplerenone initiation did not diminish the beneficial eplerenone treatment effect.
Conclusion
Eplerenone induces minor reductions in serum sodium. The beneficial effect of eplerenone was maintained regardless of the baseline serum sodium or the development of hyponatremia. Sodium alterations should not refrain clinicians from prescribing eplerenone to patients who had an MI complicated with LVSD and/or HF.
Trail registry
ClinicalTrials.gov identifier: NCT00232180. Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial.



Clin Res Cardiol: 22 Apr 2021; epub ahead of print
Martens P, Ferreira JP, Vincent J, Abreu P, ... Zannad F, Rossignol P
Clin Res Cardiol: 22 Apr 2021; epub ahead of print | PMID: 33893561
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Non-aortic cardiovascular disease in Marfan syndrome: a nationwide epidemiological study.

Andersen NH, Groth KA, Berglund A, Hove H, Gravholt CH, Stochholm K
Objectives
Studies indicate that other cardiovascular problems than aortic disease are a burden for patients with Marfan syndrome (MFS). The aim of the study was to assess the extent of this issue.
Methods
A registry-based population study of patients with a Ghent II verified MFS diagnosis. Each patient was matched with up to 100 controls on age and sex. From the Danish healthcare system, we identified 407 MFS patients (from 1977 to 2014) and their cardiovascular events and compared them with those in 40,700 controls. Total follow-up time was 16,439 person years.
Results
Mitral valve disease was significantly more common in MFS [HR: 58.9 (CI 38.1-91.1)] and happened earlier and more often in women than men with MFS [age at first registration: 22 vs. 38 years, HR: 2.1 (CI 1.0-4.4)]. Heart failure/cardiomyopathy was also more common in MFS [HR: 8.7 (CI 5.7-13.4)] and men were more affected than women, and at younger age [39 vs. 64 years, HR: 0.18 (CI 0.06-0.55)]. In all cases, atrioventricular block [HR: 4.9 (1.5-15.6)] was related to heart surgery. Supraventricular [HR: 9.7 (CI 7.5-12.7)] and ventricular tachycardia [HR: 7.7 (CI 4.2-14.3)] also occurred more often than in the control group. The risk of sudden cardiac death was increased [HR: 8.3 (CI 3.8-18.0)] but the etiology was unclear due to lack of autopsies.
Conclusion
Non-aortic cardiovascular disease in patients with MFS is exceptionally prevalent and the range of diseases varies between women and men. Physicians caring for MFS patients must be aware of this large spectrum of cardiovascular diseases.



Clin Res Cardiol: 21 Apr 2021; epub ahead of print
Andersen NH, Groth KA, Berglund A, Hove H, Gravholt CH, Stochholm K
Clin Res Cardiol: 21 Apr 2021; epub ahead of print | PMID: 33885997
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Global longitudinal strain improves risk assessment after ST-segment elevation myocardial infarction: a comparative prognostic evaluation of left ventricular functional parameters.

Holzknecht M, Reindl M, Tiller C, Reinstadler SJ, ... Metzler B, Mayr A
Aim
We aimed to investigate the comparative prognostic value of left ventricular ejection fraction (LVEF), mitral annular plane systolic excursion (MAPSE), fast manual long-axis strain (LAS) and global longitudinal strain (GLS) determined by cardiac magnetic resonance (CMR) in patients after ST-segment elevation myocardial infarction (STEMI).
Methods and results
This observational cohort study included 445 acute STEMI patients treated with primary percutaneous coronary intervention (pPCI). Comprehensive CMR examinations were performed 3 [interquartile range (IQR): 2-4] days after pPCI for the determination of left ventricular (LV) functional parameters and infarct characteristics. Primary endpoint was the occurrence of major adverse cardiac events (MACE) defined as composite of death, re-infarction and congestive heart failure. During a follow-up of 16 [IQR: 12-49] months, 48 (11%) patients experienced a MACE. LVEF (p = 0.023), MAPSE (p < 0.001), LAS (p < 0.001) and GLS (p < 0.001) were significantly related to MACE. According to receiver operating characteristic analyses, only the area under the curve (AUC) of GLS was significantly higher compared to LVEF (0.69, 95% confidence interval (CI) 0.64-0.73; p < 0.001 vs. 0.60, 95% CI 0.55-0.65; p = 0.031. AUC difference: 0.09, p = 0.020). After multivariable analysis, GLS emerged as independent predictor of MACE even after adjustment for LV function, infarct size and microvascular obstruction (hazard ratio (HR): 1.13, 95% CI 1.01-1.27; p = 0.030), as well as angiographical (HR: 1.13, 95% CI 1.01-1.28; p = 0.037) and clinical parameters (HR: 1.16, 95% CI 1.05-1.29; p = 0.003).
Conclusion
GLS emerged as independent predictor of MACE after adjustment for parameters of LV function and myocardial damage as well as angiographical and clinical characteristics with superior prognostic validity compared to LVEF.



Clin Res Cardiol: 20 Apr 2021; epub ahead of print
Holzknecht M, Reindl M, Tiller C, Reinstadler SJ, ... Metzler B, Mayr A
Clin Res Cardiol: 20 Apr 2021; epub ahead of print | PMID: 33884479
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Outcomes of patients treated with a biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stents after rotational atherectomy.

Mankerious N, Hemetsberger R, Traboulsi H, Toelg R, ... Richardt G, Allali A
Objective
To compare Orsiro biodegradable-polymer sirolimus-eluting stent (Orsiro BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) regarding target lesion failure (TLF) after rotational atherectomy (RA), with a focus on small stents (diameter ≤ 3 mm) where Orsiro BP-SES has 60 µm strut thickness, while DP-EES remains with 81 µm strut thickness.
Background
New-generation drug-eluting stent (DES) is superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Recently, the Orsiro BP-SES was superior to a DP-EES in an all comer\'s population.
Methods
Among patients who underwent RA at a single center, 121 were treated with Orsiro BP-SES and 164 with DP-EES (Promus and Xience). Those treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of TLF was assessed.
Results
After 2 years, the TLF rate in Orsiro BP-SES and DP-EES groups was 10% and 18%, respectively (adjusted HR 0.55, 95%CI 0.26-1.16, p = 0.115). The rate of TLF was significantly lower in small Orsiro BP-SES with ultra-thin struts as compared to DP-EES with the same diameters (adjusted HR 0.19, 95% CI 0.04-0.87, p = 0.032), driven by lower rates of clinically driven target lesion revascularization (log-rank p = 0.022). Age (p = 0.035), total stent length (p = 0.007) and diabetes mellitus (p = 0.011) emerged as independent predictors of TLF in the whole population.
Conclusion
In the whole cohort, Orsiro BP-SES and DP-EES had comparable rates of long-term TLF after RA. In the small stent subgroup, the Orsiro BP-SES with ultra-thin struts showed significant lower rate of TLF at 2 years.



Clin Res Cardiol: 15 Apr 2021; epub ahead of print
Mankerious N, Hemetsberger R, Traboulsi H, Toelg R, ... Richardt G, Allali A
Clin Res Cardiol: 15 Apr 2021; epub ahead of print | PMID: 33861369
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Early onset of hyperuricemia is associated with increased cardiovascular disease and mortality risk.

Li L, Zhao M, Wang C, Zhang S, ... Wu S, Xue H
Background
Hyperuricemia is associated with cardiovascular mortality, but the association of the age at hyperuricemia onset with cardiovascular disease (CVD) and mortality is still unclear.
Objective
The purpose of this study was to examine the associations of hyperuricemia onset age with CVD and all-cause mortality.
Methods
A total of 82,219 participants free of hyperuricemia and CVD from 2006 to 2015 in the Kailuan study were included. The analysis cohort comprised 18,311 new-onset hyperuricemia patients and controls matched for age and sex from the general population. Adjusted associations were estimated using Cox models for CVD and all-cause mortality across a range of ages.
Results
There were 1,021 incident cases of CVD (including 215 myocardial infarctions, 814 strokes) and 1459 deaths during an average of 5.2 years of follow-up. Patients with hyperuricemia onset at an age < 45 years had the highest hazard ratios (HRs) (1.78 (1.14-2.78) for CVD and 1.64 (1.04-2.61) for all-cause mortality relative to controls). The HRs of CVD and all-cause mortality were 1.32 (1.05-1.65) and 1.40 (1.08-1.81) for the 45-54 years age group, 1.23 (0.97-1.56) and 1.37 (1.11 to 1.72) for the 55-64 years age group, and 1.10 (0.88-1.39) and 0.88 (0.76-1.01) for the ≥ 65 years age group, respectively.
Conclusions
The age at hyperuricemia onset was identified as an important predictor of CVD and all-cause mortality risk, and the prediction was more powerful in those with a younger age of hyperuricemia onset. Early onset of hyperuricemia is associated with increased cardiovascular disease and mortality risk.



Clin Res Cardiol: 11 Apr 2021; epub ahead of print
Li L, Zhao M, Wang C, Zhang S, ... Wu S, Xue H
Clin Res Cardiol: 11 Apr 2021; epub ahead of print | PMID: 33846840
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Echocardiographic assessment of mitral regurgitation: discussion of practical and methodologic aspects of severity quantification to improve diagnostic conclusiveness.

Hagendorff A, Knebel F, Helfen A, Stöbe S, ... Merke N, Ewen S
The echocardiographic assessment of mitral valve regurgitation (MR) by characterizing specific morphological features and grading its severity is still challenging. Analysis of MR etiology is necessary to clarify the underlying pathological mechanism of the valvular defect. Severity of mitral regurgitation is often quantified based on semi-quantitative parameters. However, incongruent findings and/or interpretations of regurgitation severity are frequently observed. This proposal seeks to offer practical support to overcome these obstacles by offering a standardized workflow, an easy means to identify non-severe mitral regurgitation, and by focusing on the quantitative approach with calculation of the individual regurgitant fraction. This work also indicates main methodological problems of semi-quantitative parameters when evaluating MR severity and offers appropriateness criteria for their use. It addresses the diagnostic importance of left-ventricular wall thickness, left-ventricular and left atrial volumes in relation to disease progression, and disease-related complaints to improve interpretation of echocardiographic findings. Finally, it highlights the conditions influencing the MR dynamics during echocardiographic examination. These considerations allow a reproducible, verifiable, and transparent in-depth echocardiographic evaluation of MR patients ensuring consistent haemodynamic plausibility of echocardiographic results.



Clin Res Cardiol: 10 Apr 2021; epub ahead of print
Hagendorff A, Knebel F, Helfen A, Stöbe S, ... Merke N, Ewen S
Clin Res Cardiol: 10 Apr 2021; epub ahead of print | PMID: 33839933
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Incidence, predictors, and outcomes associated with acute kidney injury in patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 randomized trial.

Chandrasekhar J, Sartori S, Mehran R, Aquino M, ... Anthopoulos P, Dangas GD
Background
Acute kidney injury (AKI) is not uncommon in patients undergoing transcatheter aortic valve replacement (TAVR).
Objective
We examined the incidence, predictors, and outcomes of AKI from the BRAVO 3 randomized trial.
Methods
The BRAVO-3 trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin vs. unfractionated heparin (UFH). The primary endpoint of the trial was Bleeding Academic Research Consortium (BARC) type ≥ 3b bleeding at 48 h. Total follow-up was to 30 days. AKI was adjudicated using the modified RIFLE (Valve Academic Research Consortium, VARC 1) criteria through 30-day follow-up, and in a sensitivity analysis AKI was assessed at 7 days (modified VARC-2 criteria). We examined the incidence, predictors, and 30-day outcomes associated with diagnosis of AKI. We also examined the effect of procedural anticoagulant (bivalirudin or unfractionated heparin, UFH) on AKI within 48 h after TAVR.
Results
The trial population had a mean age of 82.3 ± 6.5 years including 48.8% women with mean EuroScore I 17.05 ± 10.3%. AKI occurred in 17.0% during 30-day follow-up and was associated with greater adjusted risk of 30-day death (13.0% vs. 3.5%, OR 5.84, 95% CI 2.62-12.99) and a trend for more BARC ≥ 3b bleeding (15.1% vs. 8.6%, OR 1.80, 95% CI 0.99-3.25). Predictors of 30-day AKI were baseline hemoglobin, body weight, and pre-existing coronary disease. AKI occurred in 10.7% at 7 days and was associated with significantly greater risk of 30-day death (OR 6.99, 95% CI 2.85-17.15). Independent predictors of AKI within 7 days included pre-existing coronary or cerebrovascular disease, chronic kidney disease (CKD), and transfusion which increased risk, whereas post-dilation was protective. The incidence of 48-h AKI was higher with bivalirudin compared to UFH in the intention to treat cohort (10.9% vs. 6.5%, p = 0.03), but not in the per-protocol assessment (10.7% vs. 7.1%, p = 0.08).
Conclusion
In the BRAVO 3 trial, AKI occurred in 17% at 30 days and in 10.7% at 7 days. AKI was associated with a significantly greater adjusted risk for 30-day death. Multivariate predictors of AKI at 30 days included baseline hemoglobin, body weight, and prior coronary artery disease, and predictors at 7 days included pre-existing vascular disease, CKD, transfusion, and valve post-dilation. Bivalirudin was associated with greater AKI within 48 h in the intention to treat but not in the per-protocol analysis.



Clin Res Cardiol: 10 Apr 2021; epub ahead of print
Chandrasekhar J, Sartori S, Mehran R, Aquino M, ... Anthopoulos P, Dangas GD
Clin Res Cardiol: 10 Apr 2021; epub ahead of print | PMID: 33839885
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation.

Gerçek M, Roder F, Rudolph TK, Fortmeier V, ... Rudolph V, Friedrichs KP
Background
The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow\'s disease.
Methods
38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint.
Results
Patient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5-85.3] years (PASCAL) and 82.5 [76.5-86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68-0.83] cm2 (PASCAL) and 0.70 [0.50-0.90] cm2 (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured.
Conclusion
In this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.



Clin Res Cardiol: 09 Apr 2021; epub ahead of print
Gerçek M, Roder F, Rudolph TK, Fortmeier V, ... Rudolph V, Friedrichs KP
Clin Res Cardiol: 09 Apr 2021; epub ahead of print | PMID: 33837469
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Minimally-invasive mitral valve repair of symmetric and asymmetric Barlow´s disease.

Faerber G, Tkebuchava S, Diab M, Schulze C, Bauer M, Doenst T
Objectives
Barlow´s disease represents a wide spectrum of mitral valve pathologies associated with regurgitation (MR), excess leaflet tissue, and prolapse. Repair strategies range from complex repairs with annuloplasty plus neochords through resection to annuloplasty-only. The latter requires symmetric prolapse patterns and central regurgitant jets. We aimed to assess repair success and durability, survival, and intraoperative outcomes with symmetric and asymmetric Barlow\'s disease.
Methods
Between 09/10 and 03/20, 103 patients (of 1939 with mitral valve surgery) presented with Barlow´s disease. All received surgery through mini-thoracotomy with annuloplasty plus neochords (n = 71) or annuloplasty-only (n = 31). One valve was replaced for endocarditis (repair rate: 99%).
Results
Annuloplasty-only patients were older (64 ± 16 vs. 55 ± 11 years, p = 0.008) and presented with higher risk (EuroSCORE II: 4.2 ± 4.9 vs. 1.6 ± 1.7, p = 0.007). Annuloplasty-only patients had shorter cross-clamp times (53 ± 18 min vs. 76 ± 23 min, p < 0.001) and received more tricuspid annuloplasty (15.5% vs. 48.4%, p < 0.001). Operating times were similar (170 ± 41 min vs. 164 ± 35, p = 0.455). In three patients, annuloplasty-only caused intraoperative systolic anterior motion (SAM), which was fully resolved by neochords to the posterior leaflet. There were no conversions to sternotomy or deaths at 30-days. Three patients required reoperation for recurrent MR (at 25 days, 2.8 and 7.8 years). At the latest follow-up, there was no MR in 81.4%, mild in 14.7%, and moderate in 2.9%. Three patients died due to non-cardiac reasons. Surviving patients report the absence of relevant symptoms.
Conclusions
Minimally-invasive Barlow\'s repair is safe with good durability. Annuloplasty-only may be a simple solution for complex but symmetric pathologies. However, it may carry an increased risk of intraoperative SAM.



Clin Res Cardiol: 31 Mar 2021; epub ahead of print
Faerber G, Tkebuchava S, Diab M, Schulze C, Bauer M, Doenst T
Clin Res Cardiol: 31 Mar 2021; epub ahead of print | PMID: 33792775
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic impact of atrial fibrillation in hypertrophic cardiomyopathy: a systematic review.

Alphonse P, Virk S, Collins J, Campbell T, ... Semsarian C, Kumar S
Background
Atrial fibrillation (AF) is an important arrhythmia in hypertrophic cardiomyopathy (HCM).
Objectives
To conduct a systematic review of published literature to: (a) assess the incidence of AF in HCM and (b) examine the impact of AF on risk of thromboembolism, heart failure, sudden death and mortality in HCM.
Methods
Search of all major databases (Pubmed, MEDLINE, Embase, Cochrane, Scopus, Web of Science) was performed to April 2020 using the search terms \"atrial fibrillation\" AND/OR \"hypertrophic cardiomyopathy\" in the title or abstract. 51 of the 1,565 citations met the inclusion criteria.
Results
Using random-effects modelling, the estimated pooled prevalence of AF amongst 21,887 HCM patients (36 studies) was 22.3% (95%, 19.9-24.8) and the pooled incidence of AF was 2.5 cases per person-years (95% CI 1.9-3.0). 15,444 patients from 28 studies were included in analysis of outcome data (mean age was 49.9 years; 32.7% female; mean LVEF 69%). Over a median follow up duration of 6.9 years (range 2.8-11.7 years), AF, compared to sinus rhythm (SR), was associated with significantly increased risk of thromboembolism [relative risk (RR) 7.0; 95% CI 4.6-10.7; I2 = 57%], heart failure (RR 2.8; 95% CI 1.6-4.6; I2 = 82%), sudden death (RR 1.7; 95% CI 1.3-2.3; I2 = 0%), and all-cause mortality (RR 2.5; 95% CI 1.8-3.4; I2 = 69%).
Conclusions
AF is highly prevalent in patients with HCM. The presence of AF is associated with major adverse clinical outcomes. These findings suggest that both, aggressive screening and treatment of AF, are likely to have major prognostic impact on outcomes in HCM. Incidence, prevalence and prognostic impact of AF in HCM. In this systematic review, AF incidence was 2.5 cases per-person years, prevalence was 22.3%. AF in HCM was associated with a seven-fold increased risk of thromboembolism, 2.8-fold increased risk of heart failure, 1.7-fold increased risk of sudden death and 2.5-fold increased risk of all-cause mortality.



Clin Res Cardiol: 30 Mar 2021; 110:544-554
Alphonse P, Virk S, Collins J, Campbell T, ... Semsarian C, Kumar S
Clin Res Cardiol: 30 Mar 2021; 110:544-554 | PMID: 32880676
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic implications of pericardial and pleural effusion in patients with cardiac amyloidosis.

Binder C, Duca F, Binder T, Rettl R, ... Badr Eslam R, Bonderman D
Background
Pericardial and pleural effusion are common findings in patients with cardiac amyloidosis (CA). It is not known, whether effusions correlate with right ventricular (RV) function in these patients. Furthermore, data on the prognostic significance of pleural and pericardial effusion in CA is scarce.
Methods
Patients with transthyretin (ATTR) and light chain (AL) CA were included in a clinical registry. All patients underwent transthoracic echocardiography at baseline. The presence of pericardial and pleural effusion was determined in every patient. The clinical endpoint was defined as cardiac death or heart failure hospitalization.
Results
In total, 143 patients were analysed. Of these, 85 patients were diagnosed with ATTR and 58 patients with AL. Twenty-four patients presented with isolated pericardial effusion and 35 with isolated pleural effusion. In 19 patients, both pericardial and pleural effusion were found and in 65 patients no effusion was present at baseline. The presence of pleural effusion correlated well with poor RV function, measured by global RV free-wall strain (p = 0.007) in patients with AL, but not in ATTR. No such correlation could be found for pericardial effusion in either amyloidosis subtype. Patients with AL presenting with pleural effusion had worse outcomes compared to patients with pericardial effusion alone or no effusion at baseline. In the ATTR group, there was no difference in outcomes according to presence and type of effusion.
Conclusion
More than 50% of patients with CA presented with pleural and/or pericardial effusions. While pleural effusion was clearly associated with poor RV function in AL, we were not able to detect this association with pericardial effusion.



Clin Res Cardiol: 30 Mar 2021; 110:532-543
Binder C, Duca F, Binder T, Rettl R, ... Badr Eslam R, Bonderman D
Clin Res Cardiol: 30 Mar 2021; 110:532-543 | PMID: 32914241
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Diagnostic value of cardiovascular magnetic resonance in comparison to endomyocardial biopsy in cardiac amyloidosis: a multi-centre study.

Chatzantonis G, Bietenbeck M, Elsanhoury A, Tschöpe C, ... Kelle S, Yilmaz A
Background
Cardiac amyloidosis (CA) is an infiltrative disease characterised by accumulation of amyloid deposits in the extracellular space of the myocardium-comprising transthyretin (ATTR) and light chain (AL) amyloidosis as the most frequent subtypes. Histopathological proof of amyloid deposits by endomyocardial biopsy (EMB) is the gold standard for diagnosis of CA. Cardiovascular magnetic resonance (CMR) allows non-invasive workup of suspected CA. We conducted a multi-centre study to assess the diagnostic value of CMR in comparison to EMB for the diagnosis of CA.
Methods
We studied N = 160 patients characterised by symptoms of heart failure and presence of left ventricular (LV) hypertrophy of unknown origin who presented to specialised cardiomyopathy centres in Germany and underwent further diagnostic workup by both CMR and EMB. If CA was diagnosed, additional subtyping based on EMB specimens and monoclonal protein studies in serum was performed. The CMR protocol comprised cine- and late-gadolinium-enhancement (LGE)-imaging as well as native and post-contrast T1-mapping (in a subgroup)-allowing to measure extracellular volume fraction (ECV) of the myocardium.
Results
An EMB-based diagnosis of CA was made in N = 120 patients (CA group) whereas N = 40 patients demonstrated other diagnoses (CONTROL group). In the CA group, N = 114 (95%) patients showed a characteristic pattern of LGE indicative of CA. In the CONTROL group, only 1/40 (2%) patient showed a \"false-positive\" LGE pattern suggestive of CA. In the CA group, there was no patient with elevated T1-/ECV-values without a characteristic pattern of LGE indicative of CA. LGE-CMR showed a sensitivity of 95% and a specificity of 98% for the diagnosis of CA. The combination of a characteristic LGE pattern indicating CA with unremarkable monoclonal protein studies resulted in the diagnosis of ATTR-CA (confirmed by EMB) with a specificity of 98% [95%-confidence interval (CI) 92-100%] and a positive predictive value (PPV) of 99% (95%-CI 92-100%), respectively. The EMB-associated risk of complications was 3.13% in this study-without any detrimental or persistent complications.
Conclusion
Non-invasive CMR shows an excellent diagnostic accuracy and yield regarding CA. When combined with monoclonal protein studies, CMR can differentiate ATTR from AL with high accuracy and predictive value. However, invasive EMB remains a safe invasive gold-standard and allows to differentiate CA from other cardiomyopathies that can also cause LV hypertrophy.



Clin Res Cardiol: 30 Mar 2021; 110:555-568
Chatzantonis G, Bietenbeck M, Elsanhoury A, Tschöpe C, ... Kelle S, Yilmaz A
Clin Res Cardiol: 30 Mar 2021; 110:555-568 | PMID: 33170349
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Longitudinal diastolic strain slope as an early sign for systolic dysfunction among patients with active cancer.

Hochstadt A, Arnold J, Rosen R, Sherez C, ... Topilsky Y, Laufer-Perl M
Background
Diastolic dysfunction is a common finding in patients receiving cancer therapy. This study evaluated the correlation of diastolic strain slope (Dss) with routine echocardiography diastolic parameters and its role in early detection of systolic dysfunction and cardiovascular (CV) mortality within this population.
Methods
Data were collected from the Israel Cardio-Oncology Registry (ICOR), a prospective registry enrolling adult patient receiving cancer therapy. All patients performed at least three echocardiography exams (T1, T2, T3), including left ventricle Global Longitudinal Strain (LV GLS) and Dss. Systolic dysfunction was determined by either LV GLS relative reduction of ≥ 15% or LV ejection fraction reduction > 10% to < 53%. Dss was assessed as the early lengthening rate, measured by the diastolic slope (delta%/sec).
Results
Among 144 patients, 114 (79.2%) were female with a mean age of 57.31 ± 14.3 years. Dss was significantly correlated with e\' average. Mid segment Dss change between T1 and T2 showed significant association to systolic dysfunction development (Odds Ratio (OR) = 1.04 [1.01,1.06]. p = 0.036). In multivariate prediction, Dss increase was a significant predictor for the development of systolic dysfunction (OR = 1.06 [1.03,1.1], P < 0.001).An 8% increase in Dss between T1 and T2 was associated with a trend in increased CV mortality (HR = 3.4 [0.77,15.4], p = 0.085).
Conclusions
This study is the first to use the novel measurement of Dss in patients treated with cancer therapies and to show significant correlation between routine diastolic dysfunction parameters and Dss. Changes in the mid segment were found to have significant independent early predictive value for systolic dysfunction development in univariate and multivariate analyses.



Clin Res Cardiol: 30 Mar 2021; 110:569-578
Hochstadt A, Arnold J, Rosen R, Sherez C, ... Topilsky Y, Laufer-Perl M
Clin Res Cardiol: 30 Mar 2021; 110:569-578 | PMID: 33219853
Go to: DOI | PubMed | PDF | Google Scholar |
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: 30 Mar 2021; 110:579-590
Hein S, Furkel J, Knoll M, Aus dem Siepen F, ... Kristen AV, Konstandin MH
Clin Res Cardiol: 30 Mar 2021; 110:579-590 | PMID: 33481097
Go to: DOI | PubMed | PDF | Google Scholar |
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: 30 Mar 2021; 110:479-506
Yilmaz A, Bauersachs J, Bengel F, Büchel R, ... Aus dem Siepen F, Frey N
Clin Res Cardiol: 30 Mar 2021; 110:479-506 | PMID: 33459839
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of pulse pressure on clinical outcome in extracorporeal cardiopulmonary resuscitation (eCPR) patients.

Rilinger J, Riefler AM, Bemtgen X, Jäckel M, ... Staudacher DL, Wengenmayer T
Background
Hemodynamic response to successful extracorporeal cardiopulmonary resuscitation (eCPR) is not uniform. Pulse pressure (PP) as a correlate for myocardial damage or recovery from it, might be a valuable tool to estimate the outcome of these patients.
Methods
We report retrospective data of a single-centre registry of eCPR patients, treated at the Interdisciplinary Medical Intensive Care Unit at the Medical Centre, University of Freiburg, Germany, between 01/2017 and 01/2020. The association between PP of the first 10 days after eCPR and hospital survival was investigated. Moreover, patients were divided into three groups according to their PP [low (0-9 mmHg), mid (10-29 mmHg) and high (≥ 30 mmHg)] at each time point.
Results
One hundred forty-three patients (age 63 years, 74.1% male, 40% OHCA, average low flow time 49 min) were analysed. Overall hospital survival rate was 28%. A low PP both early after eCPR (after 1, 3, 6 and 12 h) and after day 1 to day 8 was associated with reduced hospital survival. At each time point (1 h to day 5) the classification of patients into a low, mid and high PP group was able to categorize the patients for a low (5-20%), moderate (20-40%) and high (50-70%) survival rate. A multivariable analysis showed that the mean PP of the first 24 h was an independent predictor for survival (p = 0.008).
Conclusion
In this analysis, PP occurred to be a valuable parameter to estimate survival and maybe support clinical decision making in the further course of patients after eCPR.



Clin Res Cardiol: 28 Mar 2021; epub ahead of print
Rilinger J, Riefler AM, Bemtgen X, Jäckel M, ... Staudacher DL, Wengenmayer T
Clin Res Cardiol: 28 Mar 2021; epub ahead of print | PMID: 33779810
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

CMR feature tracking strain patterns and their association with circulating cardiac biomarkers in patients with hypertrophic cardiomyopathy.

Cavus E, Muellerleile K, Schellert S, Schneider J, ... Avanesov M, Patten M
Aims
CMR feature tracking strain (CMR-FT) provides prognostic information. However, there is a paucity of data in hypertrophic cardiomyopathy (HCM). We sought to analyze global CMR-FT parameters in all four cardiac chambers and to assess associations with NT-proBNP and cardiac troponin T (hsTnT) in patients with HCM.
Methods
This retrospective study included 144 HCM patients and 16 healthy controls with CMR at 1.5 T. Analyses were performed on standard steady-state free precession cine (SSFP) CMR data using a commercially available software. Global left ventricular (LV) strain was assessed as longitudinal (LVLAX-GLS), circumferential (LVLAX-GCS) and radial strain (LVLAX-GRS) on long -axis (LAX) and as LVSAX-GCS and LVSAX-GRS on short- axis (SAX). Right ventricular (RV-GLS), left atrial (LA-GLS) and right atrial (RA-GLS) strain were assessed on LAX.
Results
We found LVLAX-GLS [- 18.9 (- 22.0, - 16.0), - 23.5 (- 25.5, - 22.0) %, p = 0.0001), LVSAX-GRS [86.8 (65.9-115.5), 119.6 (91.3-143.7) %, p = 0.001] and LALAX-GLS [LA2CH-GLS 29.2 (19.1-37.7), LA2CH-GLS 38.2 (34.3-47.1) %, p = 0.0036; LA4CH-GLS 22.4 (14.6-30.7) vs. LA4CH-GLS 33.4 (28.4-37.3) %, p = 0.0033] to be impaired in HCM compared to healthy controls despite normal LVEF. Furthermore, LV and LA strain parameters were impaired in HCM with elevated NT-proBNP and/or hsTnT, despite preserved LVEF compared to HCM with normal biomarker levels. There was a moderate correlation of LV and LA CMR-FT with levels of NT-proBNP and hsTnT.
Conclusion
CMR-FT reveals LV and LA dysfunction in HCM despite normal LVEF. The association between impaired LV strain and elevated NT-proBNP and hsTnT indicates a link between unapparent functional abnormalities and disease severity in HCM. Typical CMR-FT findings in patients with hypertrophic cardiomyopathy.



Clin Res Cardiol: 28 Mar 2021; epub ahead of print
Cavus E, Muellerleile K, Schellert S, Schneider J, ... Avanesov M, Patten M
Clin Res Cardiol: 28 Mar 2021; epub ahead of print | PMID: 33779809
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Physical activity, sedentary behavior and risk of coronary artery disease, myocardial infarction and ischemic stroke: a two-sample Mendelian randomization study.

Bahls M, Leitzmann MF, Karch A, Teumer A, ... Baumeister SE, Baurecht H
Aims
Observational evidence suggests that physical activity (PA) is inversely and sedentarism positively related with cardiovascular disease risk. We performed a two-sample Mendelian randomization (MR) analysis to examine whether genetically predicted PA and sedentary behavior are related to coronary artery disease, myocardial infarction, and ischemic stroke.
Methods and results
We used single nucleotide polymorphisms (SNPs) associated with self-reported moderate to vigorous PA (n = 17), accelerometer based PA (n = 7) and accelerometer fraction of accelerations > 425 milli-gravities (n = 7) as well as sedentary behavior (n = 6) in the UK Biobank as instrumental variables in a two sample MR approach to assess whether these exposures are related to coronary artery disease and myocardial infarction in the CARDIoGRAMplusC4D genome-wide association study (GWAS) or ischemic stroke in the MEGASTROKE GWAS. The study population included 42,096 cases of coronary artery disease (99,121 controls), 27,509 cases of myocardial infarction (99,121 controls), and 34,217 cases of ischemic stroke (404,630 controls). We found no associations between genetically predicted self-reported moderate to vigorous PA, accelerometer-based PA or accelerometer fraction of accelerations > 425 milli-gravities as well as sedentary behavior with coronary artery disease, myocardial infarction, and ischemic stroke.
Conclusions
These results do not support a causal relationship between PA and sedentary behavior with risk of coronary artery disease, myocardial infarction, and ischemic stroke. Hence, previous observational studies may have been biased.



Clin Res Cardiol: 26 Mar 2021; epub ahead of print
Bahls M, Leitzmann MF, Karch A, Teumer A, ... Baumeister SE, Baurecht H
Clin Res Cardiol: 26 Mar 2021; epub ahead of print | PMID: 33774696
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Catheter ablation of short-coupled variant of torsade de pointes.

Steinfurt J, Nazer B, Aguilar M, Moss J, ... Tedrow UB, Bogossian H
Background
The short-coupled variant of torsade de pointes (sc-TdP) is a malignant arrhythmia that frequently presents with ventricular fibrillation (VF) electrical storm. Verapamil is considered the first-line therapy of sc-TdP while catheter ablation is not widely adopted. The aim of this study was to determine the origin of sc-TdP and to assess the outcome of catheter ablation using 3D-mapping.
Methods and results
We retrospectively analyzed five patients with sc-TdP who underwent 3D-mapping and ablation of sc-TdP at five different institutions. Four patients initially presented with sudden cardiac arrest, one patient experienced recurrent syncope as the first manifestation. All patients demonstrated a monomorphic premature ventricular contraction (PVC) with late transition left bundle branch block pattern, superior axis, and a coupling interval of less than 300 ms. triggering recurrent TdP and VF. In four patients, the culprit PVC was mapped to the free wall insertion of the moderator band (MB) with a preceding Purkinje potential in two patients. Catheter ablation using 3D-mapping and intracardiac echocardiography eliminated sc-TdP in all patients, with no recurrence at mean 2.7 years (range 6 months to 8 years) of follow-up.
Conclusion
3D-mapping and intracardiac echocardiography demonstrate that sc-TdP predominantly originates from the MB free wall insertion and its Purkinje network. Catheter ablation of the culprit PVC at the MB free wall junction leads to excellent short- and long-term results and should be considered as first-line therapy in recurrent sc-TdP or electrical storm.



Clin Res Cardiol: 25 Mar 2021; epub ahead of print
Steinfurt J, Nazer B, Aguilar M, Moss J, ... Tedrow UB, Bogossian H
Clin Res Cardiol: 25 Mar 2021; epub ahead of print | PMID: 33770204
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Alcohol-induced right bundle branch block is associated with a benign outcome in HOCM after alcohol septum ablation (ASA).

Lawin D, Lawrenz T, Radke K, Wolff A, Stellbrink C
Introduction
Alcohol septum ablation (ASA) is a treatment option for hypertrophic obstructive cardiomyopathy (HOCM). We examined the impact of ASA-induced bundle branch block (BBB) on clinical and hemodynamic features.
Methods and results
We retrospectively analysed 98 HOCM patients with regard to ASA-induced BBB. Clinical examination was performed at baseline, early after ASA and at chronic follow-up (FU). ASA reduced left ventricular outflow tract gradient (LVOTG) during chronic FU (69.2 ± 41.6 pre vs. 31.8 ± 30.3 mmHg post ASA; p < 0.05) and interventricular septal diameter (21.7 ± 3.4 pre vs. 18.7 ± 5.0 mm post ASA; p < 0.05). ASA-induced early right BBB (RBBB) until discharge was observed in 44.9% and chronic RBBB at FU in 32.7%. Left BBB (LBBB) occurred in 13.3% early after ASA and in only 4.1% at chronic FU. Chronic RBBB was associated with more pronounced exercise-induced LVOTG reduction (102.1 ± 55.2 with vs. 73.6 ± 60.0 mmHg without; p < 0.05). 6-min-walk-test (6-MWT) and NYHA class were not affected by RBBB. LBBB had no influence on LVOTG, 6-MWT and symptoms. More ethanol was injected in patients with early RBBB (1.1 ± 0.4 vs. 0.8 ± 0.3 ml without; p < 0.05), who also showed higher mean CK release (827 ± 341 vs. 583 ± 279 U/l without; p < 0.05). Pacemaker implantation during FU was necessary in 11.5% of patients with early RBBB, 3.1% with chronic RBBB, 7.7% with early LBBB and 0% with chronic LBBB (p = n.s. for BBB vs. no BBB).
Conclusion
ASA-induced RBBB is associated with a higher volume of infused ethanol and higher maximum CK release. RBBB does not adversely affect the clinical outcome or need for pacemaker implantation but was associated with higher exercise-induced LVOTG reduction during chronic FU.



Clin Res Cardiol: 25 Mar 2021; epub ahead of print
Lawin D, Lawrenz T, Radke K, Wolff A, Stellbrink C
Clin Res Cardiol: 25 Mar 2021; epub ahead of print | PMID: 33772362
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Incidence and outcomes of perioperative myocardial infarction/injury diagnosed by high-sensitivity cardiac troponin I.

Gualandro DM, Puelacher C, Lurati Buse G, Glarner N, ... Mueller C, BASEL-PMI Investigators
Background
 Perioperative myocardial infarction/injury (PMI) diagnosed by high-sensitivity troponin (hs-cTn) T is frequent and a prognostically important complication of non-cardiac surgery. We aimed to evaluate the incidence and outcome of PMI diagnosed using hs-cTnI, and compare it to PMI diagnosed using hs-cTnT.
Methods
We prospectively included 2455 patients at high cardiovascular risk undergoing 3111 non-cardiac surgeries, for whom hs-cTnI and hs-cTnT concentrations were measured before surgery and on postoperative days 1 and 2. PMI was defined as a composite of perioperative myocardial infarction (PMIInfarct) and perioperative myocardial injury (PMIInjury), according to the Fourth Universal Definition of Myocardial Infarction. All-cause mortality was the primary endpoint.
Results
Using hs-cTnI, the incidence of overall PMI was 9% (95% confidence interval [CI] 8-10%), including PMIInfarct 2.6% (95% CI 2.0-3.2) and PMIInjury 6.1% (95% CI 5.3-6.9%), which was lower versus using hs-cTnT: overall PMI 15% (95% CI 14-16%), PMIInfarct 3.7% (95% CI 3.0-4.4) and PMIInjury 11.3% (95% CI 10.2-12.4%). All-cause mortality occurred in 52 (2%) patients within 30 days and 217 (9%) within 1 year. Using hs-cTnI, both PMIInfarct and PMIInjury were independent predictors of 30-day all-cause mortality (adjusted hazard ratio [aHR] 2.5 [95% CI 1.1-6.0], and aHR 2.8 [95% CI 1.4-5.5], respectively) and, 1-year all-cause mortality (aHR 2.0 [95% CI 1.2-3.3], and aHR 1.8 [95% CI 1.2-2.7], respectively). Overall, the prognostic impact of PMI diagnosed by hs-cTnI was comparable to the prognostic impact of PMI using hs-cTnT.
Conclusions
Using hs-cTnI, PMI is less common versus using hs-cTnT. Using hs-cTnI, both PMIInfarct and PMIInjury remain independent predictors of 30-day and 1-year mortality.



Clin Res Cardiol: 24 Mar 2021; epub ahead of print
Gualandro DM, Puelacher C, Lurati Buse G, Glarner N, ... Mueller C, BASEL-PMI Investigators
Clin Res Cardiol: 24 Mar 2021; epub ahead of print | PMID: 33768367
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Intravenous iron for heart failure with evidence of iron deficiency: a meta-analysis of randomised trials.

Graham FJ, Pellicori P, Ford I, Petrie MC, Kalra PR, Cleland JGF
Background
The recent AFFIRM-AHF trial assessing the effect of intravenous (IV) iron on outcomes in patients hospitalised with worsening heart failure who had iron deficiency (ID) narrowly missed its primary efficacy endpoint of recurrent hospitalisations for heart failure (HHF) or cardiovascular (CV) death. We conducted a meta-analysis to determine whether these results were consistent with previous trials.
Methods
We searched for randomised trials of patients with heart failure investigating the effect of IV iron vs placebo/control groups that reported HHF and CV mortality from 1st January 2000 to 5th December 2020. Seven trials were identified and included in this analysis. A fixed effect model was applied to assess the effects of IV iron on the composite of first HHF or CV mortality and individual components of these.
Results
Altogether, 2,166 patients were included (n = 1168 assigned to IV iron; n = 998 assigned to control). IV iron reduced the composite of HHF or CV mortality substantially [OR 0.73; (95% confidence interval 0.59-0.90); p = 0.003]. Outcomes were consistent for the pooled trials prior to AFFIRM-AHF. Whereas first HHF were reduced substantially [OR 0.67; (0.54-0.85); p = 0.0007], the effect on CV mortality was uncertain but appeared smaller [OR 0.89; (0.66-1.21); p = 0.47].
Conclusion
Administration of IV iron to patients with heart failure and ID reduces the risk of the composite outcome of first heart failure hospitalisation or cardiovascular mortality, but this outcome may be driven predominantly by an effect on HHF. At least three more substantial trials of intravenous iron are underway.



Clin Res Cardiol: 22 Mar 2021; epub ahead of print
Graham FJ, Pellicori P, Ford I, Petrie MC, Kalra PR, Cleland JGF
Clin Res Cardiol: 22 Mar 2021; epub ahead of print | PMID: 33755777
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Is there a benefit of ICD treatment in patients with persistent severely reduced systolic left ventricular function after TAVI?

Nies RJ, Frerker C, Adam M, Kuhn E, ... Baldus S, Schmidt T
Background
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and heart failure with severely reduced ejection fraction, prediction of postprocedural left ventricular ejection fraction (LVEF) improvement is challenging. Decision-making and timing for implantable cardioverter defibrillator (ICD) treatment are difficult and benefit is still unclear in this patient population.
Objective

Aims:
of the study were to analyse long-term overall mortality in TAVI-patients with a preprocedural LVEF ≤ 35% regarding LVEF improvement and effect of ICD therapy.
Methods and results
Retrospective analysis of a high-risk TAVI-population suffering from severe AS and heart failure with a LVEF ≤ 35%. Out of 1485 TAVI-patients treated at this center between January 2013 and April 2018, 120 patients revealed a preprocedural LVEF ≤ 35% and had sufficient follow-up. 36.7% (44/120) of the patients suffered from persistent reduced LVEF without a postprocedural increase above 35% within 1 year after TAVI or before death, respectively. Overall mortality was neither significantly reduced by LVEF recovery above 35% (p = 0.31) nor by additional ICD treatment in patients with persistent LVEF ≤ 35% (p = 0.33).
Conclusion
In high-risk TAVI-patients suffering from heart failure with LVEF ≤ 35%, LVEF improvement to more than 35% did not reduce overall mortality. Patients with postprocedural persistent LVEF reduction did not seem to benefit from ICD treatment. Effects of LVEF improvement and ICD treatment on mortality are masked by the competing risk of death from relevant comorbidities.



Clin Res Cardiol: 22 Mar 2021; epub ahead of print
Nies RJ, Frerker C, Adam M, Kuhn E, ... Baldus S, Schmidt T
Clin Res Cardiol: 22 Mar 2021; epub ahead of print | PMID: 33758967
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic value of the chest X-ray in patients hospitalised for heart failure.

Pan D, Pellicori P, Dobbs K, Bulemfu J, ... Cleland JGF, Clark AL
Background
Patients admitted to hospital with heart failure will have had a chest X-ray (CXR), but little is known about their prognostic significance. We aimed to report the prevalence and prognostic value of the initial chest radiograph findings in patients admitted to hospital with heart failure (acute heart failure, AHF).
Methods
The erect CXRs of all patients admitted with AHF between October 2012 and November 2016 were reviewed for pulmonary venous congestion, Kerley B lines, pleural effusions and alveolar oedema. Film projection (whether anterior-posterior [AP] or posterior-anterior [PA]) and cardiothoracic ratio (CTR) were also recorded.
Trial registration
ISRCTN96643197
Results:
Of 1145 patients enrolled, 975 [median (interquartile range) age 77 (68-83) years, 61% with moderate, or worse, left ventricular systolic dysfunction, and median NT-proBNP 5047 (2337-10,945) ng/l] had an adequate initial radiograph, of which 691 (71%) were AP. The median CTR was 0.57 (IQR 0.53-0.61) in PA films and 0.60 (0.55-0.64) in AP films. Pulmonary venous congestion was present in 756 (78%) of films, Kerley B lines in 688 (71%), pleural effusions in 649 (67%) and alveolar oedema in 622 (64%). A CXR score was constructed using the above features. Increasing score was associated with increasing age, urea, NT-proBNP, and decreasing systolic blood pressure, haemoglobin and albumin; and with all-cause mortality on multivariable analysis (hazard ratio 1.10, 95% confidence intervals 1.07-1.13, p < 0.001).
Conclusions
Radiographic evidence of congestion on a CXR is very common in patients with AHF and is associated with other clinical measures of worse prognosis. Signs of heart failure are highly prevalent in patients presenting to hospital with acute heart failure and when combined into a chest x-ray score, relate to a worse long term risk of death.



Clin Res Cardiol: 21 Mar 2021; epub ahead of print
Pan D, Pellicori P, Dobbs K, Bulemfu J, ... Cleland JGF, Clark AL
Clin Res Cardiol: 21 Mar 2021; epub ahead of print | PMID: 33754159
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Outcome of aortic stenosis according to invasive cardiac damage staging after transcatheter aortic valve replacement.

Schewel J, Kuck KH, Frerker C, Schmidt T, Schewel D
Background
In recent studies, a 5-stage cardiac damage classification in severe aortic stenosis (AS) based on echocardiographic parameters has shown to provide predictive value regarding clinical outcome. The objective of this study was to investigate the prognostic impact of a cardiac damage classification based on invasive hemodynamics in patients with AS undergoing transcatheter aortic valve replacement (TAVR).
Methods
A total of 1400 patients with symptomatic AS and full invasive hemodynamic assessment before TAVR were included. Patients were categorized according to their cardiac damage stage into five groups that are defined as: stage 0, no cardiac damage; stage 1, left ventricular damage; stage 2, left atrial and/or mitral valve damage; stage 3, pulmonary vasculature and/or tricuspid valve damage; stage 4, right ventricular damage.
Results
9.9% patients were classified as stage 0, 23.6% as stage 1, the majority of patients as stage 2 (33.5%), 23.1% as stage 3 and 10% as stage 4. One- and 4-year mortality were 10.1%/29.5% in stage 0, 16.1%/60.6% in stage 1, 17.3%/39.4% in stage 2, 22%/54.6% in stage 3, 27.1%/62.2% in stage 4 (p = 0.001/p < 0.001). The extent of cardiac damage was independently associated with increased mortality after TAVR (HR 1.16 per each increment in stage, 95% confidence interval 1.03-1.18; p = 0.018).
Conclusions
Cardiac damage staging in severe AS patients based on invasive hemodynamics appears to show strong association between the extent of cardiac damage and post-TAVR mortality. This staging classification provides predictive value and may improve risk stratification, therapy management and decision-making in patients with AS. Invasive Staging Classification of Cardiac Damage in Severe Symptomatic Aortic Stenosis has an Impact on Outcome after TAVR. (Top) Invasive staging criteria for cardiac damage in five stages using left ventricular end-diastolic pressure (LVEDP) for stage 1 (red), post-capillary wedge pressure (PCWP) for stage 2 (green), systolic pulmonary artery pressure (SPAP) for stage 3 (purple) and right atrial pressure (RAP) for stage 4 (yellow). The cake chart shows the distribution of the different stage in the whole cohort. (Bottom) Survival Analyses According to Stage of Cardiac Damage after Transcatheter Aortic Valve Replacement using Invasive Criteria. Kaplan-Meier plots comparing overall (left) and cardiovascular (right) 4-year survival showing with the more advancing stage a higher mortality rate.



Clin Res Cardiol: 19 Mar 2021; epub ahead of print
Schewel J, Kuck KH, Frerker C, Schmidt T, Schewel D
Clin Res Cardiol: 19 Mar 2021; epub ahead of print | PMID: 33744987
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Iron deficiency and short-term adverse events in patients with decompensated heart failure.

Palau P, Llàcer P, Domínguez E, Tormo JP, ... Bayés-Genís A, Núñez J
Background
For patients with heart failure (HF), iron deficiency (ID) is a common therapeutic target. However, little is known about the utility of transferrin saturation (TSAT) or serum ferritin for risk stratification in decompensated HF (DHF) or the European Society of Cardiology\'s (ESC) current definition of ID (ferritin < 100 μg/L or TSAT < 20% if ferritin is 100-299 μg/L). We evaluated the association between these potential markers of ID and the risk of 30-day readmission for HF or death in patients with DHF.
Methods
We retrospectively included 1701 patients from a multicenter registry of DHF. Serum ferritin and TSAT were evaluated 24-72 h after hospital admission, and multivariable Cox regression was used to assess their association with the composite endpoint.
Results
Participants\' median (quartiles) age was 76 (68-82) years, 43.8% were women, and 51.7% had a left ventricular ejection fraction > 50%. Medians for NT-proBNP, TSAT, and ferritin were 4067 pg/mL (1900-8764), 14.1% (9.0-20.3), and 103 ug/L (54-202), respectively. According to the current ESC definition, 1,246 (73.3%) patients had ID. By day 30, there were 177 (10.4%) events (95 deaths and 85 HF readmission). After multivariable adjustment, lower TSAT was associated with outcome (p = 0.009) but serum ferritin was not (HR 1.00; 95% confidence interval 0.99-1.00, p = 0.347).
Conclusions
Lower TSAT, but not ferritin, was associated with a higher risk of short-term events in patients with DHF. Further research is needed to confirm these findings and the utility of serum ferritin as a marker of ID in DHF.



Clin Res Cardiol: 14 Mar 2021; epub ahead of print
Palau P, Llàcer P, Domínguez E, Tormo JP, ... Bayés-Genís A, Núñez J
Clin Res Cardiol: 14 Mar 2021; epub ahead of print | PMID: 33721056
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Colchicine in ischemic heart disease: the good, the bad and the ugly.

D\'Amario D, Cappetta D, Cappannoli L, Princi G, ... Liuzzo G, Crea F
Inflammation is the main pathophysiological process involved in atherosclerotic plaque formation, progression, instability, and healing during the evolution of coronary artery disease (CAD). The use of colchicine, a drug used for decades in non-ischemic cardiovascular (CV) diseases and/or systemic inflammatory conditions, stimulated new perspectives on its potential application in patients with CAD. Previous mechanistic and preclinical studies revealed anti-inflammatory and immunomodulatory effects of colchicine exerted through its principal mechanism of microtubule polymerization inhibition, however, other pleiotropic effects beneficial to the CV system were observed such as inhibition of platelet aggregation and suppression of endothelial proliferation. In randomized double-blinded clinical trials informing our clinical practice, low doses of colchicine were associated with the significant reduction of cardiovascular events in patients with stable CAD and chronic coronary syndrome (CCS) while in patients with a recent acute coronary syndrome (ACS), early initiation of colchicine treatment significantly reduced major adverse CV events (MACE). On the other hand, the safety profile of colchicine and its potential causal relationship to the observed increase in non-CV deaths warrants further investigation. For these reasons, postulates of precision medicine and patient-tailored approach with regards to benefits and harms of colchicine treatment should be employed at all times due to potential toxicity of colchicine as well as the currently unresolved signal of harm concerning non-CV mortality. The main goal of this review is to provide a balanced, critical, and comprehensive evaluation of currently available evidence with respect to colchicine use in the setting of CAD.



Clin Res Cardiol: 12 Mar 2021; epub ahead of print
D'Amario D, Cappetta D, Cappannoli L, Princi G, ... Liuzzo G, Crea F
Clin Res Cardiol: 12 Mar 2021; epub ahead of print | PMID: 33713178
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of chronic obstructive pulmonary disease on 10-year mortality after percutaneous coronary intervention and bypass surgery for complex coronary artery disease: insights from the SYNTAX Extended Survival study.

Wang R, Tomaniak M, Takahashi K, Gao C, ... Onuma Y, Serruys PW
Aims
To evaluate the impact of chronic obstructive pulmonary disease (COPD) on 10-year all-cause death and the treatment effect of CABG versus PCI on 10-year all-cause death in patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) and COPD.
Methods
Patients were stratified according to COPD status and compared with regard to clinical outcomes. Ten-year all-cause death was examined according to the presence of COPD and the revascularization strategy.
Results
COPD status was available for all randomized 1800 patients, of whom, 154 had COPD (8.6%) at the time of randomization. Regardless of the revascularization strategy, patients with COPD had a higher risk of 10-year all-cause death, compared with those without COPD (43.1% vs. 24.9%; hazard ratio [HR]: 2.03; 95% confidence interval [CI]: 1.56-2.64; p < 0.001). Among patients with COPD, CABG appeared to have a slightly lower risk of 10-year all-cause death compared with PCI (42.3% vs. 43.9%; HR: 0.96; 95% CI: 0.59-1.56, p = 0.858), whereas among those without COPD, CABG had a significantly lower risk of 10-year all-cause death (22.7% vs. 27.1%; HR: 0.81; 95% CI: 0.67-0.99, p = 0.041). There was no significant differential treatment effect of CABG versus PCI on 10-year all-cause death between patients with and without COPD (p interaction = 0.544).
Conclusions
COPD was associated with a higher risk of 10-year all-cause death after revascularization for complex coronary artery disease. The presence of COPD did not significantly modify the beneficial effect of CABG versus PCI on 10-year all-cause death.
Trial registration
SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.



Clin Res Cardiol: 11 Mar 2021; epub ahead of print
Wang R, Tomaniak M, Takahashi K, Gao C, ... Onuma Y, Serruys PW
Clin Res Cardiol: 11 Mar 2021; epub ahead of print | PMID: 33710385
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Re-appraisal of the obesity paradox in heart failure: a meta-analysis of individual data.

Marcks N, Aimo A, Januzzi JL, Vergaro G, ... Emdin M, Brunner-La Rocca HP
Background
Higher body mass index (BMI) is associated with better outcome compared with normal weight in patients with HF and other chronic diseases. It remains uncertain whether the apparent protective role of obesity relates to the absence of comorbidities. Therefore, we investigated the effect of BMI on outcome in younger patients without co-morbidities as compared to older patients with co-morbidities in a large heart failure (HF) population.
Methods
In an individual patient data analysis from pooled cohorts, 5,819 patients with chronic HF and data available on BMI, co-morbidities and outcome were analysed. Patients were divided into four groups based on BMI (i.e. ≤ 18.5 kg/m2, 18.5-25.0 kg/m2; 25.0-30.0 kg/m2; 30.0 kg/m2). Primary endpoints included all-cause mortality and HF hospitalization-free survival.
Results
Mean age was 65 ± 12 years, with a majority of males (78%), ischaemic HF and HF with reduced ejection fraction. Frequency of all-cause mortality or HF hospitalization was significantly worse in the lowest two BMI groups as compared to the other two groups; however, this effect was only seen in patients older than 75 years or having at least one relevant co-morbidity, and not in younger patients with HF only. After including medications and N-terminal pro-B-type natriuretic peptide and high-sensitivity cardiac troponin concentrations into the model, the prognostic impact of BMI was largely absent even in the elderly group with co-morbidity.
Conclusions
The present study suggests that obesity is a marker of less advanced disease, but does not have an independent protective effect in patients with chronic HF. Categories of BMI are only predictive of poor outcome in patients aged > 75 years or with at least one co-morbidity (bottom), but not in those aged < 75 years without co-morbidities (top). The prognostic effect largely disappears in multivariable analyses even for the former group. These findings question the protective effect of obesity in chronic heart failure (HF).



Clin Res Cardiol: 10 Mar 2021; epub ahead of print
Marcks N, Aimo A, Januzzi JL, Vergaro G, ... Emdin M, Brunner-La Rocca HP
Clin Res Cardiol: 10 Mar 2021; epub ahead of print | PMID: 33704552
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Continuation or discontinuation of oral anticoagulants after HAS-BLED scores increase in patients with atrial fibrillation.

Chao TF, Chan YH, Chiang CE, Tuan TC, ... Lip GYH, Chen SA
Background
The bleeding risk profile of patients with atrial fibrillation (AF) may change over time, and the increment of HAS-BLED score is perceived to result in discontinuations of oral anticoagulants (OACs).
Objectives
To investigate the changes of HAS-BLED scores of AF patients initially with a low bleeding risk. The associations between continuation or discontinuation of OACs and clinical outcomes after patients\' bleeding risk profile worsened (ie HAS-BLED increased) were studied.
Methods
The present study used Taiwan nationwide health insurance research database. From year 2000 to 2015, a total of 24,990 AF patients aged ≥ 20 years with a CHA2DS2-VASc score  ≥ 1 (males) or  ≥ 2 (females) having an HAS-BLED score of 0-2 who were treated with OACs were identified and followed up for changes of the HAS-BLED scores. Patients who did not refill OACs within 90 days after their HAS-BLED scores increased to  ≥ 3 were defined as discontinuations of OACs. The risks of clinical outcomes were compared between patients who continued or stopped OACs once their HAS-BLED scores increased to  ≥ 3.
Results
Mean HAS-BLED score of study population increased from 1.54 to 3.33. At end of 1 year, 5,229 (20.9%) patients had an increment of their HAS-BLED scores to  ≥ 3, mainly due to newly diagnosed hypertension, stroke, bleeding, and concomitant drug therapies. Among 4777 patients who consistently had an HAS-BLED score  ≥ 3, 1,062 (22.2%) stopped their use of OACs. Patients who kept on OACs (n = 3715; 77.8%) even after their HAS-BLED scores increased to ≥ 3 were associated with a lower risk of ischemic stroke (aHR 0.60, 95%CI 0.53-0.69), major bleeding (aHR 0.78, 95%CI 0.67-0.91), all-cause mortality (aHR 0.88, 95%CI 0.79-0.97), and any adverse events (aHR 0.75, 95%CI 0.68-0.82) adjusted for age, sex, heart failure, and HAS-BLED score. These results were consistent among the cohorts after propensity matching.
Conclusions
For patients whose HAS-BLED scores increased to ≥ 3, the continuation of OACs was associated with better clinical outcomes. An increased HAS-BLED score in anticoagulated AF patients may not be the only reason to withhold OACs, but reminds physicians to correct modifiable bleeding risk factors and follow up patients more closely. Associations between Continuation or Discontinuation of Oral Anticoagulants and Risks of Clinical Outcomes after HAS-BLED Scores Increased AF atrial fibrillation; aHR adjusted hazard ratio; ICH intra-cranial hemorrhage; OACs oral anticoagulants.



Clin Res Cardiol: 10 Mar 2021; epub ahead of print
Chao TF, Chan YH, Chiang CE, Tuan TC, ... Lip GYH, Chen SA
Clin Res Cardiol: 10 Mar 2021; epub ahead of print | PMID: 33704551
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Analysis of causes of death in patients with implanted defibrillators.

Nägele H, Gröene E, Stierle D, Nägele MP
Aims
Implantable cardioverter defibrillators (ICDs) are used for primary or secondary prevention of sudden cardiac death. We sought to clarify prognosis and causes of death after ICD implantation.
Methods and results
A total of 2743 patients with ICDs implanted during 1990-2020 were analyzed. Median age was 68.5 (59.6-74.6) years; 21% women, median left ventricular ejection fraction (LVEF) was 30 (23-35), 52% had an ischemic etiology and 77% had a primary preventive indication. Mortality rate after 10 years was 22, 44, 55, and 72% in the 1st, 2nd, 3rd, and 4th age quartile, respectively. The calculated median sex and age adjusted loss of life years compared to the average German population was 9.7 (6.1-14.0) years. Prognosis was independently related to sex, age, LVEF, and glomerular filtration rate. 713 out of 852 deaths could be classified to a specific cause. Congestive heart failure (CHF) accounted for death in 214 (30%) and sudden death (SD) for 144 patients (20%). Postmortem interrogation of devices in 74 patients revealed VT/VF in 39 and no episodes in 35 patients. Cancer was identified as the cause of death in 121 patients (17% of cases), of which 36 were bronchial carcinomas. 73 (10%) of patients died due to infection. 67 patients (9%) died within 24 h of procedures. Compared to other causes, significantly more life years were lost associated with procedures and SD: 9.3 (5.7-12.9) versus 12.1 (7.4-15.2) and 11.9 (7.6-17.8) years.
Conclusion
Life expectancy of ICD patients is lower than for the general population. Mortality is predominantly due to CHF, but there is still a considerable rate of SD. The occurrence of cancers, most importantly bronchial carcinomas, and infections, warrants protective measures. Some deaths during procedures are possibly preventable. Patients with ICDs comprise a vulnerable cohort, and treatment has to be optimized in many directions to improve prognosis.



Clin Res Cardiol: 08 Mar 2021; epub ahead of print
Nägele H, Gröene E, Stierle D, Nägele MP
Clin Res Cardiol: 08 Mar 2021; epub ahead of print | PMID: 33687520
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic benefit from an early invasive strategy in patients with non-ST elevation acute coronary syndrome (NSTEACS): evaluation of the new risk stratification in the NSTEACS European guidelines.

Martinón-Martínez J, Álvarez Álvarez B, González Ferrero T, García-Rodeja Arias F, ... Gude Sampedro F, González Juanatey JR
Objectives
The objective of our work is to evaluate the prognostic benefit of an early invasive strategy in patients with high-risk NSTACS according to the recommendations of the 2020 clinical practice guidelines during long-term follow-up.
Methods
This retrospective observational study included 6454 consecutive NSTEACS patients. We analyze the effects of early coronary angiography (< 24 h) in patients with: (a) GRACE risk score > 140 and (b) patients with \"established NSTEMI\" (non ST-segment elevation myocardial infarction defined by an increase in troponins) or dynamic ST-T-segment changes with a GRACE risk score < 140.
Results
From 2003 to 2017, 6454 patients with \"new high-risk NSTEACS\" were admitted, and 6031 (93.45%) of these underwent coronary angiography. After inverse probability of treatment weighting, the long-term cumulative probability of being free of all-cause mortality, cardiovascular mortality and MACE differed significantly due to an early coronary intervention in patients with NSTEACS and GRACE > 140 [HR 0.62 (IC 95% 0.57-0.67), HR 0.62 (IC 95% 0.56-0.68), HR 0.57 (IC 95% 0.53-0.61), respectively]. In patients with NSTEACS and GRACE < 140 with established NSTEMI or ST/T-segment changes, the benefit of the early invasive strategy is only observed in the reduction of MACE [HR 0.62 (IC 95% 0.56-0.68)], but not for total mortality [HR 0.96 (IC 95% 0.78-1.2)] and cardiovascular mortality [HR 0.96 (IC 95% 0.75-1.24)].
Conclusions
An early invasive management is associated with reduced all-cause mortality, cardiovascular mortality and MACE in NSTEACS with high GRACE risk score. However, this benefit is less evident in the subgroup of patients with a GRACE score < 140 with established NSTEMI or ST/T-segment changes.



Clin Res Cardiol: 08 Mar 2021; epub ahead of print
Martinón-Martínez J, Álvarez Álvarez B, González Ferrero T, García-Rodeja Arias F, ... Gude Sampedro F, González Juanatey JR
Clin Res Cardiol: 08 Mar 2021; epub ahead of print | PMID: 33687519
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Heart failure re-hospitalizations and subsequent fatal events in coronary artery disease: insights from COMMANDER-HF, EPHESUS, and EXAMINE.

Ferreira JP, Cleland JG, Lam CSP, Anker SD, ... Greenberg B, Zannad F
Background
Patients with coronary artery disease (CAD) are at increased risk of developing and being hospitalised for heart failure (HFH). However, the risk of HFH versus ischemic events may vary among patients with CAD, depending on whether acute myocardial infarction (MI), left ventricular dysfunction or decompensated HF is present at baseline.
Aims
We aim to explore the risk of non-fatal events (HFH, MI, stroke) and subsequent death in 3 landmark trials, COMMANDER-HF, EPHESUS and EXAMINE that, together, included patients with CAD with and without reduced ejection fraction and acute MI.
Methods
Events, person-time metrics and time-updated Cox models.
Results
In COMMANDER-HF the event-rate for the composite of AMI, stroke or all-cause death was 13.5 (12.8-14.3) events/100 py. Rates for AMI and stroke were much lower (2.2 [2.0-2.6] and 1.3 [1.1-1.6] events/100 py, respectively) than the rate of HFH (16.9 [16.1-17.9] events/100 py). In EPHESUS, the rates of MI and stroke were also lower than the rate of HFH: 7.2 (6.7-7.8), 1.9 (1.7-2.3), and 10.6 (9.9-11.3) events/100 py, but this was not true for EXAMINE with 4.4 (4.0-4.9), 0.7 (0.6-0.9), and 2.4 (2.0-2.7) events/100 py, respectively. In all 3 trials, a non-fatal event (HFH, MI or stroke) during follow-up doubled the risk of subsequent mortality. This most commonly followed a HFH.
Conclusions
A first or recurrent HFH is common in patients with CAD and AMI or HFrEF and indicates a poor prognosis. Preventing the development of heart failure after AMI and control of congestion in patients with CAD and HFrEF are key unmet needs and therapeutic targets.
Registration
ClinicalTrials.gov Identifier: NCT01877915. URL: https://clinicaltrials.gov/ct2/show/NCT01877915 .



Clin Res Cardiol: 07 Mar 2021; epub ahead of print
Ferreira JP, Cleland JG, Lam CSP, Anker SD, ... Greenberg B, Zannad F
Clin Res Cardiol: 07 Mar 2021; epub ahead of print | PMID: 33686472
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Soluble triggering receptor expressed on myeloid cells-1 is a marker of organ injuries in cardiogenic shock: results from the CardShock Study.

Kimmoun A, Duarte K, Harjola VP, Tarvasmäki T, ... Gibot S, CardShock Investigators and the GREAT network
Aims
Optimal outcome after cardiogenic shock (CS) depends on a coordinated healing response in which both debris removal and extracellular matrix tissue repair play a crucial role. Excessive inflammation can perpetuate a vicious circle, positioning leucocytes as central protagonists and potential therapeutic targets. High levels of circulating Triggering Receptor Expressed on Myeloid cells-1 (TREM-1), were associated with death in acute myocardial infarction confirming excessive inflammation as determinant of bad outcome. The present study aims to describe the association of soluble TREM-1 with 90-day mortality and with various organ injuries in patients with CS.
Methods and results
This is a post-hoc study of CardShock, a prospective, multicenter study assessing the clinical presentation and management in patients with CS. At the time of this study, 87 patients had available plasma samples at either baseline, and/or 48 h and/or 96-120 h for soluble TREM-1 (sTREM-1) measurements. Plasma concentration of sTREM-1 was higher in 90-day non-survivors than survivors at baseline [median: 1392 IQR: (724-2128) vs. 621 (525-1233) pg/mL, p = 0.008), 48 h (p = 0.019) and 96-120 h (p = 0.029). The highest tertile of sTREM-1 at baseline (threshold: 1347 pg/mL) was associated with 90-day mortality with an unadjusted HR 3.08 CI 95% (1.48-6.42). sTREM-1 at baseline was not associated to hemodynamic parameters (heart rate, blood pressure, use of vasopressors or inotropes) but rather with organ injury markers: renal (estimated glomerular filtration rate, p = 0.0002), endothelial (bio-adrenomedullin, p = 0.018), myocardial (Suppression of Tumourigenicity 2, p = 0.002) or hepatic (bilirubin, p = 0.008).
Conclusion
In CS patients TREM-1 pathway is highly activated and gives an early prediction of vital organ injuries and outcome.



Clin Res Cardiol: 06 Mar 2021; epub ahead of print
Kimmoun A, Duarte K, Harjola VP, Tarvasmäki T, ... Gibot S, CardShock Investigators and the GREAT network
Clin Res Cardiol: 06 Mar 2021; epub ahead of print | PMID: 33677708
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Who is who in cardiovascular research? What a review of Nobel Prize nominations reveals about scientific trends.

Drobietz M, Loerbroks A, Hansson N
Background
Since 1901, at least 15 scholars who contributed to cardiovascular research have received a Nobel prize in physiology or medicine.
Methods
Using the Nobel nomination database (nobelprize.org), which contains 5950 nominations in the accessible period from 1901 to 1953 in physiology or medicine, we listed all international nominees who contributed to cardiovascular research. We subsequently collected nomination letters and jury reports of the prime candidates from the archive of the Nobel Committee in Sweden to identify shortlisted candidates.
Results
The five most frequently nominated researchers with cardiovascular connections from 1901 to 1953 were, in descending order, the surgeon René Leriche (1879-1955) (FR) with a total of 79 nominations, the physiologist and 1924 Nobel laureate Willem Einthoven (1860-1927) (NL) (31 nominations), the surgeon Alfred Blalock (1899-1964) (US) (29 nominations), the pharmacologist and 1936 Nobel laureate Otto Loewi (1873-1961) (DE, AT, US) (27 nominations) and the paediatric cardiologist Helen Taussig (1898-1986) (US) (24 nominations). The research of these scholars merely hints at the width of topics brought up by nominators ranging from the physiological and pathological basics to the diagnosis and (surgical) interventions of diseases such as heart malformation or hypertension.
Conclusion
We argue that an analysis of Nobel Prize nominations can reconstruct important scientific trends within cardiovascular research during the first half of the twentieth century.



Clin Res Cardiol: 05 Mar 2021; epub ahead of print
Drobietz M, Loerbroks A, Hansson N
Clin Res Cardiol: 05 Mar 2021; epub ahead of print | PMID: 33675420
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
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
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:

This program is still in alpha version.