Publications by authors named "Eberhard Grube"

284 Publications

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

Catheter Cardiovasc Interv 2021 Jul 31. Epub 2021 Jul 31.

Department of Medicine, University of Bonn, Bonn, Germany.

Objectives: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study.

Background: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce.

Methods: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients.

Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low.

Conclusions: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.
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http://dx.doi.org/10.1002/ccd.29889DOI Listing
July 2021

Transcatheter Triple-Valve Intervention.

JACC Cardiovasc Interv 2021 Jul 30;14(14):e179-e181. Epub 2021 Jun 30.

Heart Center Bonn, Department of Medicine II, University Hospital Bonn, Bonn, Germany.

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http://dx.doi.org/10.1016/j.jcin.2021.05.029DOI Listing
July 2021

Frailty, malnutrition, and the endocrine system impact outcome in patients undergoing aortic valve replacement.

Catheter Cardiovasc Interv 2021 Jun 18. Epub 2021 Jun 18.

Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.

Background: Frailty is a multidimensional syndrome that affects mortality after aortic valve replacement (AVR). Malnutrition is often associated with the development of frailty. However, data regarding the association of frailty with nutritional status and underlying endocrinological dysregulation in patients with severe aortic valve stenosis are limited.

Objectives: We aimed to systematically screen for frailty and malnutrition, to evaluate for underlying endocrinological disorders and inflammation, and to assess the ability of these parameters to predict outcomes after AVR.

Methods: Our study included 373 patients undergoing transcatheter and surgical AVR. Frailty was assessed using the Fried Frailty Phenotype (FFP), Essential Frailty Toolset, Lawton-Brody, and Katz Index. Malnutrition was measured using the Mini Nutritional Assessment (MNA-LF) and Controlling Nutritional Status. Outcomes of interest were 30-day and one-year mortality.

Results: The prevalence of frailty ranged from 6.4% to 65.7% and malnutrition from 5.9% to 10.5%, depending on the evaluation tool. Both parameters were associated with higher levels of cortisol and parathormone as well as lower levels of IGF-1, testosterone, DHEAS, and c-reactive protein. Malnutrition was associated with increased 30-day mortality, and both frailty and malnutrition with increased one-year mortality. In a multivariate analysis, malnutrition measured by the MNA-LF (OR: 2.32 [95%CI: 1.19-4.53], p = 0.01) and frailty as assessed by the FFP (OR: 1.42 [95%CI: 1.02-1.96], p = 0.03) were independent predictors of one-year mortality.

Conclusion: The prevalence of frailty and malnutrition varies significantly depending on the assessment tool. Both syndromes share common endocrinological alterations. Frailty and malnutrition are independent risk factors for mortality after AVR.
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http://dx.doi.org/10.1002/ccd.29821DOI Listing
June 2021

Association of heart failure duration with clinical outcomes after transcatheter mitral valve repair for functional mitral regurgitation.

Catheter Cardiovasc Interv 2021 Sep 19;98(3):E412-E419. Epub 2020 Nov 19.

Heart Center Bonn, Department of Medicine II, University Hospital Bonn, Bonn, Germany.

Background: Little is known about the association of heart failure (HF) chronicity with clinical outcomes after transcatheter mitral valve repair (TMVR) for functional mitral regurgitation (MR).

Methods: From January 2011 to March 2019, consecutive patients with functional MR who underwent a MitraClip procedure were analyzed. The patients were divided into two groups according to HF duration-those with duration ≤18 months and those with >18 months. The primary outcome measure was a composite of all-cause mortality and re-HF rehospitalization within 1 year after the procedure. These outcomes were also assessed separately. A Cox proportional hazard model was conducted for investigating the association of HF duration with the primary outcome.

Results: A total of 208 patients were analyzed. Patients with HF duration >18 months had a higher rate of the primary outcome compared to those with HF duration ≤18 months (38.1 vs. 19.0%, log-rank p = .003). A longer duration of HF was associated with an increased risk of the primary outcomes (adjusted-HR of >18 months, 2.12 95% CI, 1.14-4.19; p = .03; adjusted-HR (hazard ratios) for 1 year increase, 1.05; 95% CI, 1.02-1.09; p = .004). The association of HF duration with the primary outcomes showed a steep rise during the first 2 years of HF duration and progressive increase after 5 years.

Conclusions: A longer HF duration before TMVR was associated with an increased risk of all-cause mortality or HF rehospitalization. HF duration can be used for the risk stratification marker in patients undergoing TMVR for functional MR.
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http://dx.doi.org/10.1002/ccd.29390DOI Listing
September 2021

Impact of Coronary Artery Disease on Outcomes in Patients Undergoing Percutaneous Edge-to-Edge Repair.

JACC Cardiovasc Interv 2020 09;13(18):2137-2145

Department of Cardiology, University Hospital Bonn, Bonn, Germany. Electronic address:

Objectives: The aim of this observational study was to evaluate the impact of concomitant coronary artery disease (CAD) on outcomes in patients undergoing percutaneous valve repair with the MitraClip system.

Background: Mitral valve regurgitation and CAD are often coexistent in elderly patients undergoing percutaneous mitral valve repair. The impact of CAD and revascularization on outcomes in this patient cohort, however, remains uncertain.

Methods: In 444 MitraClip patients, CAD severity was assessed, represented by the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), as well as the residual SS (rSS) and SYNTAX score II (SS-II). Patients were stratified according to CAD severity and SS-II values (SS ≤3 vs. SS >3 and SS-II ≤45 vs. SS-II >45) and according to remaining CAD burden into 2 groups (rSS = 0 vs. rSS >0) to compare 1-year all-cause mortality.

Results: Higher SS, rSS, and SS-II were associated with mortality (22% for SS >3 vs. 9.6% for SS ≤3 [p < 0.001], 31.4% for rSS >0 vs. 9.6% for rSS = 0 [p < 0.001], and 17.1% for SS-II > 45 vs. 11.2% for SS-II ≤45 [p = 0.044]). The rSS was an independent predictor of 1-year all-cause mortality (p = 0.001) in multivariate analysis.

Conclusions: The complexity of CAD, as assessed using the SS, is associated with outcomes in patients undergoing MitraClip procedures. The burden of residual CAD after percutaneous coronary intervention is an independent predictor of 1-year all-cause mortality. Patients undergoing complete revascularization had the most favorable outcomes independent of mitral regurgitation etiology.
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http://dx.doi.org/10.1016/j.jcin.2020.05.031DOI Listing
September 2020

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

Clin Res Cardiol 2021 Mar 26;110(3):368-376. Epub 2020 Aug 26.

Division of Cardiology, Pulmonology and Vascular Medicine, Department of Internal Medicine, Heinrich Heine University, Medical Faculty, Moorenstr. 5, 40225, Düsseldorf, Germany.

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.
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http://dx.doi.org/10.1007/s00392-020-01731-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907023PMC
March 2021

Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study.

EuroIntervention 2020 11;16(10):850-857

Regional Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom.

Aims: The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice.

Methods And Results: FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge.

Conclusions: The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap. ClinicalTrials.gov Identifier: NCT03417011
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http://dx.doi.org/10.4244/EIJ-D-20-00279DOI Listing
November 2020

Safety and Efficacy of Protamine Administration for Prevention of Bleeding Complications in Patients Undergoing TAVR.

JACC Cardiovasc Interv 2020 06;13(12):1471-1480

Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany. Electronic address:

Objectives: The aim of this study was to evaluate whether protamine administration for heparin reversal after transcatheter aortic valve replacement (TAVR) reduces bleeding complications and affects patient outcomes.

Background: Occurrence of major bleeding complications in patients undergoing TAVR is associated with increased morbidity and mortality.

Methods: This study included 873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal. Standard access management included the use of pre-closure devices, manual compression, and percutaneous transluminal angioplasty or implantation of a covered stent graft, if necessary. The study complied with Good Clinical Practice guidelines and was approved by the local ethics committee. Written informed consent was obtained from all patients.

Results: The primary endpoint, a composite of 30-day all-cause mortality and life-threatening and major bleeding, occurred less frequently in the protamine administration group (3.2%) compared with the control group (8.7%) (p = 0.003). This was driven mainly by lower rates of life-threatening and major bleeding in the protamine group (0.1% vs. 2.6% [p < 0.001] and 1.0% vs. 4.1% [p = 0.008], respectively). Furthermore, protamine administration resulted in a significantly shorter hospital stay (11.1 ± 5.8 days vs. 12.7 ± 7.8 days; p = 0.05). In the overall cohort, stroke was observed in 1.9% and myocardial infarction in 0.2% of patients, with no significant difference between the groups (p > 0.05). Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.

Conclusions: Protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal. Occurrence of stroke and myocardial infarction was not increased by protamine administration.
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http://dx.doi.org/10.1016/j.jcin.2020.03.041DOI Listing
June 2020

Transcatheter aortic valve implantation in nonagenarians - old…but not obsolete!

EuroIntervention 2020 Apr;15(17):1474-1475

Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

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http://dx.doi.org/10.4244/EIJV15I17A268DOI Listing
April 2020

Chimney Stenting for Coronary Occlusion During TAVR: Insights From the Chimney Registry.

JACC Cardiovasc Interv 2020 03;13(6):751-761

Institut Cardiovasculaire de Paris, Massy, France.

Objectives: The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO).

Background: CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication.

Methods: In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR.

Results: To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days.

Conclusions: Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.
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http://dx.doi.org/10.1016/j.jcin.2020.01.227DOI Listing
March 2020

TAVR outcome after reclassification of aortic valve stenosis by using a hybrid continuity equation that combines computed tomography and echocardiography data.

Catheter Cardiovasc Interv 2020 10 19;96(4):958-967. Epub 2020 Mar 19.

Heart Center Bonn, Bonn, Germany.

Background: In the continuity equation, assumption of a round-shaped left ventricular outflow tract (LVOT) leads to underestimation of the true aortic valve area in two-dimensional echocardiography. The current study evaluated whether inclusion of the LVOT area, as measured by computed tomography (CT), reclassifies the degree of aortic stenosis (AS) and assessed the impact on patient outcome after transcatheter aortic valve replacement (TAVR).

Methods And Results: Four hundred and twenty-two patients with indexed aortic valve area index (AVAi) of <0.6 cm /m , assessed by using the classical continuity equation (mean age: 81.5 ± 6.1 years, 51% female, mean left ventricular ejection fraction: 53.2 ± 13.6%), underwent TAVR and were included. After inclusion of the CT measured LVOT area into the continuity equation, the hybrid AVAi led to a reclassification of 30% (n = 128) of patients from severe to moderate AS. Multivariate predictors for reclassification were male sex, lower mean aortic gradient, and lower annulus/LVOT ratio (all p < .01). Reclassified patients had significantly higher sST2 at baseline and higher NT-proBNP values at baseline and 6 months follow-up compared to non-reclassified patients. Acute kidney injury was experienced more frequently after TAVR by reclassified patients, but no significant mortality difference occurred during 2 years of follow-up.

Conclusion: The hybrid AVAi reclassifies a significant portion of low-gradient severe AS patients into moderate AS. Reclassified patients showed increased fibrosis and heart failure markers at baseline compared to non-reclassified patients. But reclassification had no significant impact on mortality up to 2 years after TAVR. Routine assessment of hybrid AVAi seems not to improve further risk stratification of TAVR patients.
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http://dx.doi.org/10.1002/ccd.28852DOI Listing
October 2020

Simplify TAVR?: To Pre-Dilate, or Not to Pre-Dilate, That Is the Question.

JACC Cardiovasc Interv 2020 03;13(5):603-605

Heart Center Bonn, Department of Medicine II, University Hospital Bonn, Bonn, Germany.

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http://dx.doi.org/10.1016/j.jcin.2020.01.213DOI Listing
March 2020

Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry.

JACC Cardiovasc Interv 2020 03 12;13(6):739-747. Epub 2020 Feb 12.

Interventional Cardiology, Mauriziano Hospital, Torino, Italy.

Objectives: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR).

Background: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality.

Methods: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019.

Results: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19).

Conclusions: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.
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http://dx.doi.org/10.1016/j.jcin.2019.11.024DOI Listing
March 2020

Predictive factors and long-term prognosis of transcatheter aortic valve implantation-associated endocarditis.

Clin Res Cardiol 2020 Sep 4;109(9):1165-1176. Epub 2020 Feb 4.

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

Background: There are still limited data regarding transcatheter aortic valve implantation (TAVI) endocarditis.

Objectives: The objective of the present study was to investigate the predictor and long-term outcome of TAVI endocarditis.

Methods: Consecutive patients undergoing TAVI at the University of Bonn were prospectively enrolled in this study. Transcatheter heart valve (THV) endocarditis was defined according to Duke criteria. The primary outcome was all-cause death within a 5-year follow-up.

Results: 1448 successful TAVI patients were eligible for the study and 17 patients (1.2%) developed THV endocarditis during the follow-up period (median 294 days). A multivariable logistic regression analysis identified age (odds ratio [OR] 0.90; P = 0.001) and residual paravalvular leakage (PVL) ≥ 2 after TAVI (OR 5.15; P = 0.015) as the main predictors for the occurrence of TAVI endocarditis. Additional analyses revealed that younger patients were significantly associated with higher rates of diabetes (P = 0.001), hemodialysis (P < 0.001), prior cardiac surgery (P < 0.001), and chronic obstructive pulmonary disease (COPD) (P < 0.001). A Kaplan-Meier analysis showed a significantly worse prognosis in TAVI patients with endocarditis than in patients without (log-rank; P = 0.03) during the 5-year follow-up. A multivariable Cox proportional hazard analysis revealed that TAVI endocarditis is an independent predictor of long-term mortality (hazard ratio 4.17; 95% CI 1.91-9.07; P < 0.001).

Conclusions: Our study identified lower age and residual PVL ≥ 2 as predictors for THV endocarditis, which itself may be considered as an independent predictor of long-term mortality after TAVI.
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http://dx.doi.org/10.1007/s00392-020-01609-wDOI Listing
September 2020

Predictive Value of the Platelet-to-Lymphocyte Ratio in Cancer Patients Undergoing Transcatheter Aortic Valve Replacement.

JACC CardioOncol 2019 Dec 17;1(2):159-169. Epub 2019 Dec 17.

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Germany.

Objectives: The purpose of this study is to investigate the predictive value of the platelet-to-lymphocyte ratio (PLR)in cancer patients undergoing transcatheter aortic valve replacement (TAVR).

Background: The PLR is a promising marker to predict clinical outcomes in various cancer types as well as in cardiovascular disease.

Methods: Consecutive TAVR patients were enrolled in the study. We stratified patients into 2 groups: cancer and noncancer. Baseline complete blood counts with a differential hemogram were collected before TAVR. The primary outcome was all-cause death within a 3-year follow-up.

Results: In total, 240 of 1,204 patients (19.9%) had a cancer history. Cancer patients had a significantly higher baseline PLR than noncancer patients (median [interquartile range], 159.8 [109.6 to 244.6] vs. 150.3 [108.7 to 209.0]; p = 0.024). Kaplan-Meier analysis revealed that cancer patients had worse outcomes than noncancer patients (log-rank p < 0.001). Patients who died had a significantly higher baseline PLR than those who survived both in the cancer (p = 0.009) and noncancer (p = 0.027) groups. Multivariable analyses showed that the PLR (by 100 increase) was an independent predictor of adverse outcomes in both cancer (hazard ratio: 1.07; 95% confidence interval: 1.02 to 1.13; p = 0.006) and noncancer (hazard ratio: 1.20; 95% confidence interval: 1.06 to 1.36; p = 0.004). The highest mortality was observed for patients with cancer and increased PLR (above the median) (log-rank p < 0.001).

Conclusions: Cancer patients undergoing TAVR had a significantly higher PLR than those without cancer. Higher PLR was associated with a worse outcome following TAVR.
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http://dx.doi.org/10.1016/j.jaccao.2019.10.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8352187PMC
December 2019

Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry.

Circ Cardiovasc Interv 2019 11 11;12(11):e008154. Epub 2019 Nov 11.

Heart Center Trier, Krankenhaus der Barmherzigen Brüder Trier, Germany (J.L., N.W.).

Background: Optimal plaque preparation of calcified coronary lesions is key to prevent stent failure. The purpose of this study was to determine the strategy success and safety of intravascular lithotripsy (IVL) in calcified lesions of an all-comers cohort.

Methods: Patients with calcified coronary lesions were screened in 3 centers. Seventy-one patients were eligible for IVL. Patients were assigned to (group A) primary IVL therapy for patients with calcified de-novo lesions (n=39 lesions), (group B) secondary IVL therapy for patients with calcified lesions in which noncompliant balloon dilatation failed (n=22 lesions), and (group C) tertiary IVL therapy in patients with stent underexpansion after previous stenting (n=17 lesions). Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis) and safety outcomes (procedural complications, in-hospital major adverse cardiovascular event).

Results: Seventy-eight calcified lesions were treated using the Shockwave C balloon. Mean diameter stenosis of calcified lesions was 71.8±13.1% at baseline, decreased to 45.1±17.4% immediately after IVL, and to 17.5±15.2% after stenting. Mean minimal lumen diameter was 1.01±0.49 mm at baseline and increased to 1.90±0.61 after IVL, and to 2.88±0.56 mm after stenting. The primary end point of strategy success was reached in 84.6% (group A), 77.3% (group B), and 64.7% (group C). Device delivery and IVL treatment were possible in all lesions. Four type b dissections were observed without further sequelae. No patient suffered from in-hospital major adverse cardiovascular event. Seven Shockwave balloons ruptured during treatment without any sequelae.

Conclusions: IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008154DOI Listing
November 2019

Fractional flow reserve in patients with coronary artery disease undergoing TAVI: a prospective analysis.

Clin Res Cardiol 2020 Jun 2;109(6):746-754. Epub 2019 Nov 2.

Heart Center Bonn, Department of Medicine II, University Hospital Bonn, Sigmund-Freud-Str. 25, 53105, Bonn, Germany.

Objectives: To determine the true prevalence of CAD in AS patients, to detect changes of the hemodynamic significance of coronary lesions following TAVI, to explore to what extent FFR-positive CAD might influence outcome and finally to develop a management algorithm for this patient subset.

Methods: From May 2016 to March 2018, diagnostic coronary angiography was performed in 246 patients before TAVI. In the presence of coronary lesions with a diameter stenosis ≥ 50%, FFR was measured. In patients with positive FFR ≤ 0.80, a control angiography was performed 6-8 weeks after TAVI.

Results: The study cohort was 81.0 ± 6.1 years old, 48.4% of the patients were male. 53.3% had concomitant CAD. 35.9% of these patients underwent PCI before TAVI due to functionally significant left main CAD and/or severe stenosis ≥ 90%. 31 patients underwent FFR measurements in cumulative 38 coronary lesions. Prior to TAVI, a negative FFR could be detected in 18 lesions, whereas a positive FFR was found in entirely 20 lesions. A control angiography and FFR measurement was performed in cumulative 13 lesions. Comparing the FFR values, there was no significant difference (0.77 ± 0.04 vs. 0.76 ± 0.08; p = 0.11).

Conclusion: Concomitant CAD was diagnosed in 53.3% of TAVI patients. FFR did not significantly change after TAVI, confirming the validity of FFR to evaluate coronary lesions in this specific clinical setting. Given the low rates of cardiac adverse events, it might therefore be considered to treat coronary stenoses not involving left main and those with a diameter stenosis < 90% after TAVI.
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http://dx.doi.org/10.1007/s00392-019-01563-2DOI Listing
June 2020

Peripheral perfusion of lower limb after transcatheter aortic valve implantation (TAVI) in patients with peripheral artery disease.

Int J Cardiol 2019 12 7;297:36-42. Epub 2019 Sep 7.

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

Background: In TAVI patients, peripheral arterial disease (PAD) is a common concomitant disease. Given the fact that calcified severe aortic stenosis (AS) limits the blood flow that reaches the periphery, it is conceivable that the treatment of AS may positively influence the peripheral perfusion.

Aim: To evaluate whether, and if so, how the peripheral perfusion changes after TAVI in patients with PAD comparing with patients without PAD.

Methods: On the basis of objective vascular tests, peripheral perfusion in the lower extremities were studied in 108 TAVI patients with or without concomitant PAD.

Results: 108 consecutive patients with a median logistic EuroSCORE of 12.7 (IQR: 8.5 to 22.0) % underwent TAVI with an extensive pre- and post-procedural assessment of the peripheral perfusion. In patients without PAD, the time to peak flow (tPF) did not differ before (6.45 ± 5.24 s) and after (6.45 ± 5.91 s) TAVI (p = 1.000). In PAD patients, however, the tPF was significantly shortened following TAVI (9.51 ± 9.45 s vs. 8.33 ± 8.16 s, p < 0.001), thereby reflecting an improvement in peripheral blood flow. The resting arterial blood flow before and after TAVI showed the highest level at the beginning (0 s) and constantly decreased afterwards. No improvement in the peak flow was achieved.

Conclusions: In PAD patients, TAVI led to improved peripheral blood flow as reflected by shortened time to peak flow measurements.
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http://dx.doi.org/10.1016/j.ijcard.2019.09.008DOI Listing
December 2019

Comparison of a Complete Percutaneous versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results from the Randomized SURTAVI Trial.

Circulation 2019 Sep 3. Epub 2019 Sep 3.

Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Background: For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach.

Methods: The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years.

Results: Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76).

Conclusions: For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG.

Clinical Trial Registration: URL: www.clinicaltrials.gov Unique Identifier: NCT01586910.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.118.039564DOI Listing
September 2019

Early versus newer generation transcatheter heart valves for transcatheter aortic valve implantation: Echocardiographic and hemodynamic evaluation of an all-comers study cohort using the dimensionless aortic regurgitation index (AR-index).

PLoS One 2019 31;14(5):e0217544. Epub 2019 May 31.

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

Aims: More than mild paravalvular aortic regurgitation (pAR) negatively impacts prognosis after transcatheter aortic valve implantation (TAVI). "Newer generation" transcatheter heart valves (THVs) including Direct Flow Medical, Medtronic Evolut R, Boston Lotus, and Edwards SAPIEN 3 valve system promise to improve outcome by reducing the rate of TAVI-related issues such as pAR. Aim was to evaluate and compare the hemodynamic performance with AR index of "early" vs. "newer generation" THVs and its impact on outcome.

Methods And Results: In 805 patients undergoing TAVI, the degree of pAR was assessed using imaging modalities (angiography, echocardiography) and hemodynamic measurements (aortic regurgitation index, ARI ratio). Severity of pAR and outcome were assessed according to the VARC-2 criteria. 805 patients underwent TAVI with use of the CoreValve (n = 400), SAPIEN XT (n = 48), Direct Flow Medical (n = 38), Evolut R (n = 114), Lotus (n = 104), or SAPIEN 3 (n = 101) prosthesis. TTE post TAVI revealed that a total of 7.3% of the patients showed moderate/severe pAR. The occurrence of greater than mild pAR occurred less frequently in patients treated with "newer generation" THVs (p<0.001): CoreValve (11.3%), SAPIEN XT (12.5%), Direct Flow Medical (5.3%), Evolut R (5.3%), Lotus (0.0%), and SAPIEN 3 (0.0%). The AR index was significantly higher (p<0.001) in patients receiving "newer generation" prostheses compared to those in whom "earlier generation" THVs were used. However, the ARI was only predictive of cumulative all-cause mortality at 1 and 3 years in "early generation", but not in "newer generation" THVs. In the overall cohort, 30-day and 1-year mortality was 4.8% and 20.1%, respectively. In patients treated with "newer generation" devices, the respective mortality rates remained substantially below those of patients treated with "earlier generation" THVs (30-day mortality: 2.5% vs. 6.7%, p< 0.001; 1-year mortality: 11.2% vs. 27.2%, p<0.001).

Conclusion: TAVI with use of "newer generation" THVs showed significantly reduced pAR and improved outcomes compared to "early generation" devices that could at least in part be explained by more favorable hemodynamics.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0217544PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6544262PMC
February 2020

Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial.

Catheter Cardiovasc Interv 2019 Jun 22;93(7):1374-1381. Epub 2019 May 22.

Science and Strategy Consulting Group, Basking Ridge, New Jersey.

Background/objective: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear.

Methods: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke).

Results: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death.

Conclusions: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.
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http://dx.doi.org/10.1002/ccd.28295DOI Listing
June 2019

Impact of Hemodynamic Support on Outcome in Patients Undergoing High-Risk Percutaneous Coronary Intervention.

Am J Cardiol 2019 07 10;124(1):20-30. Epub 2019 Apr 10.

Department of Medicine II, Heart Center, University Hospital Bonn, Bonn, Germany. Electronic address:

The use of left-ventricular (LV) hemodynamic support might facilitate high-risk percutaneous coronary interventions (PCI) in patients with complex coronary artery disease. The impact on outcome is a matter of ongoing debate. We assessed the outcome of high-risk patients who underwent protected PCI in comparison to patients who underwent unprotected high-risk PCI. One hundred and thirty nine patients underwent nonemergent high-risk PCI; 24 (17%) patients underwent protected PCI. To address selection bias, we performed a propensity score matched subanalysis. The primary end point was the occurrence of a major adverse cardiac event during the first year. Patients with protected PCI had a higher logistic EuroSCORE (logES) (protected PCI: 19% vs unprotected PCI: 12%; p = 0.01), a higher SYNTAX score (45 vs 36, p = 0.07), and significantly more often reduced LV function (40% vs 55%; p < 0.001). In protected PCI patients, complete revascularization was more often achieved (87% vs 58%, p = 0.007) without the occurrence of death at 30 days of follow-up (0% vs 4%, p = 0.31). After propensity score matching, patients who underwent protected PCI had a similar 1-year major adverse cardiac event rate compared with patients who underwent unprotected PCI (21% vs 17%, p = 0.67), despite significantly higher procedural complexity for example, more often complex left main bifurcation lesions (71% vs 29%; p = 0.004). In conclusion, 1-year outcome of patients who underwent protected PCI was not different from that in patients with less complex procedures without hemodynamic support, despite more complex coronary anatomy, a higher comorbidity burden, and more often reduced LV function.
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http://dx.doi.org/10.1016/j.amjcard.2019.03.050DOI Listing
July 2019

The "Big Five" Complications After Transcatheter Aortic Valve Replacement: Do We Still Have to Be Afraid of Them?

JACC Cardiovasc Interv 2019 02;12(4):370-372

Heart Center Bonn, Department of Medicine II, University Hospital Bonn, Bonn, Germany.

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http://dx.doi.org/10.1016/j.jcin.2018.12.019DOI Listing
February 2019

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study.

JACC Cardiovasc Interv 2018 11;11(22):2326-2334

Department of Innovative Interventions in Cardiology, University of Bonn, Bonn, Germany.

Objectives: This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice.

Background: The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking.

Methods: This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms.

Results: The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%.

Conclusions: The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
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http://dx.doi.org/10.1016/j.jcin.2018.07.032DOI Listing
November 2018

Unbreak My Heart (Valve): Can Ultrasound Be Used for the Treatment of a Degenerated Surgical Bioprosthesis?

JACC Basic Transl Sci 2017 Aug 28;2(4):384-385. Epub 2017 Aug 28.

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

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http://dx.doi.org/10.1016/j.jacbts.2017.06.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6034450PMC
August 2017

Combination of high-sensitivity C-reactive protein with logistic EuroSCORE improves risk stratification in patients undergoing TAVI.

EuroIntervention 2018 Aug;14(6):629-636

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

Aims: The aim of this study was to assess the clinical value of biomarkers to identify TAVI patients at high risk for adverse outcome, to assess whether these biomarkers provide prognostic information beyond that of established clinical risk scores, and to assess whether a combined multi-marker strategy can improve clinical decision making.

Methods And Results: In 683 TAVI patients, biomarkers reflecting various pathophysiologic systems were measured before TAVI. The primary endpoint was one-year all-cause mortality. Other outcomes were recorded according to the VARC-2 criteria. Thirty-day and one-year mortality was 2.9% and 12.0%, respectively. Non-survivors at one year had higher risk scores and increased median biomarker levels. Logistic EuroSCORE in combination with hs-CRP had the highest predictive value for 30-day (AUC 0.740 [95% CI: 0.667-0.812], p=0.1117) and one-year mortality (AUC 0.631 [95% CI: 0.569-0.693], p=0.0403). In multivariate regression analysis, logistic EuroSCORE in combination with hs-CRP showed the strongest association with one-year mortality. Combinations of increasing medians of logistic EuroSCORE results and hs-CRP levels allowed the stratification of the TAVI patients into subgroups with one-year mortality rates ranging from 6.6% up to 18.2%.

Conclusions: hs-CRP alongside the logistic EuroSCORE was an independent predictor of one-year all-cause mortality in TAVI patients. A combination of both might help to predict procedural risk and outcome better.
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http://dx.doi.org/10.4244/EIJ-D-18-00059DOI Listing
August 2018

Complete percutaneous approach versus surgical access in transfemoral transcatheter aortic valve implantation: results from a multicentre registry.

Kardiol Pol 2018 13;76(1):202-208. Epub 2017 Nov 13.

Department of Medicine II, Heart Centre Bonn, University Hospital Bonn, Bonn, Germany

Background: Although the femoral approach is the most common route utilised in transcatheter aortic valve implantation (TAVI), it still carries a substantial risk of severe bleeding and vascular complications.

Aim: The aim of our study was to compare the safety and efficacy of the complete percutaneous (CPC) approach with surgical cut-down and closure (SCC) in TAVI patients.

Methods: The study population comprised 683 patients with severe aortic stenosis, who underwent transfemoral TAVI. Bleeding and vascular complications were defined according to the Valve Academic Research Consortium (VARC-2) criteria. Propensity-matched cohorts were created to reduce the potential bias of non-random assignment to the type of vascular access technique (SSC, n = 203 vs. CPC, n = 203).

Results: The rate of minor vascular complications was higher in the CPC cohort (18.2% vs. 9.9%, p = 0.02). There were no differences in major vascular complications or in any type of bleedings between the two groups. Age (odds ratio [OR] 1.044; 95% confidence interval [CI] 1.003-1.09, p = 0.046), preprocedural haemoglobin (OR 0.849; 95% CI 0.760-0.944, p = 0.03), and baseline estimated glomerular filtration rate < 30 mL/min (OR 3.216; 95% CI 1.176-8.741, p = 0.021) were independent predictors of life-threatening/disabling and major bleedings. Diabetes remained the only independent predictor of major vascular complications (OR 1.695; 95% CI 1.014-3.156, p = 0.046).

Conclusions: In this retrospective analysis both vascular access and closure techniques were associated with a similar risk of severe bleeding and major vascular events. However, these findings should be further confirmed in a multicentre, randomised study.
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http://dx.doi.org/10.5603/KP.a2017.0205DOI Listing
November 2018
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