Publications by authors named "Werner Scholtz"

46 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

Idiopathic pulmonary arterial hypertension phenotypes determined by cluster analysis from the COMPERA registry.

J Heart Lung Transplant 2020 12 30;39(12):1435-1444. Epub 2020 Sep 30.

Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Dresden, Germany.

The term idiopathic pulmonary arterial hypertension (IPAH) is used to categorize patients with pre-capillary pulmonary hypertension of unknown origin. There is considerable variability in the clinical presentation of these patients. Using data from the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension, we performed a cluster analysis of 841 patients with IPAH based on age, sex, diffusion capacity of the lung for carbon monoxide (DLCO; <45% vs ≥45% predicted), smoking status, and presence of comorbidities (obesity, hypertension, coronary heart disease, and diabetes mellitus). A hierarchical agglomerative clustering algorithm was performed using Ward's minimum variance method. The clusters were analyzed in terms of baseline characteristics; survival; and response to pulmonary arterial hypertension (PAH) therapy, expressed as changes from baseline to follow-up in functional class, 6-minute walking distance, cardiac biomarkers, and risk. Three clusters were identified: Cluster 1 (n = 106; 12.6%): median age 45 years, 76% females, no comorbidities, mostly never smokers, DLCO ≥45%; Cluster 2 (n = 301; 35.8%): median age 75 years, 98% females, frequent comorbidities, no smoking history, DLCO mostly ≥45%; and Cluster 3 (n = 434; 51.6%): median age 72 years, 72% males, frequent comorbidities, history of smoking, and low DLCO. Patients in Cluster 1 had a better response to PAH treatment than patients in the 2 other clusters. Survival over 5 years was 84.6% in Cluster 1, 59.2% in Cluster 2, and 42.2% in Cluster 3 (unadjusted p < 0.001 for comparison between all groups). The population of patients diagnosed with IPAH is heterogenous. This cluster analysis identified distinct phenotypes, which differed in clinical presentation, response to therapy, and survival.
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http://dx.doi.org/10.1016/j.healun.2020.09.011DOI Listing
December 2020

Pulmonary Hypertension in Adults with Congenital Heart Disease: Real-World Data from the International COMPERA-CHD Registry.

J Clin Med 2020 05 13;9(5). Epub 2020 May 13.

Missionsärztliche Klinik gGmbH, Abteilung für Innere Medizin, 97074 Würzburg, Germany.

Introduction: Pulmonary hypertension (PH) is a common complication in patients with congenital heart disease (CHD), aggravating the natural, post-operative, or post-interventional course of the underlying anomaly. The various CHDs differ substantially in characteristics, functionality, and clinical outcomes among each other and compared with other diseases with pulmonary hypertension.

Objective: To describe current management strategies and outcomes for adults with PH in relation to different types of CHD based on real-world data.

Methods And Results: COMPERA (Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension) is a prospective, international PH registry comprising, at the time of data analysis, >8200 patients with various forms of PH. Here, we analyzed a subgroup of 680 patients with PH due to CHD, who were included between 2007 and 2018 in 49 specialized centers for PH and/or CHD located in 11 European countries. At enrollment, the patients´ median age was 44 years (67% female), and patients had either pre-tricuspid shunts, post-tricuspid shunts, complex CHD, congenital left heart or aortic disease, or miscellaneous other types of CHD. Upon inclusion, targeted therapies for pulmonary arterial hypertension (PAH) included endothelin receptor antagonists, PDE-5 inhibitors, prostacyclin analogues, and soluble guanylate cyclase stimulators. Eighty patients with Eisenmenger syndrome were treatment-naïve. While at inclusion the primary PAH treatment for the cohort was monotherapy (70% of patients), with 30% of the patients on combination therapy, after a median observation time of 45.3 months, the number of patients on combination therapy had increased significantly, to 50%. The use of oral anticoagulants or antiplatelets was dependent on the underlying diagnosis or comorbidities. In the entire COMPERA-CHD cohort, after follow-up and receiving targeted PAH therapy ( = 511), 91 patients died over the course of a 5-year follow up. The 5-year Kaplan-Meier survival estimate for CHD associated PH was significantly better than that for idiopathic PAH (76% vs. 54%; < 0.001). Within the CHD associated PH group, survival estimates differed particularly depending on the underlying diagnosis and treatment status.

Conclusions: In COMPERA-CHD, the overall survival of patients with CHD associated PH was dependent on the underlying diagnosis and treatment status, but was significantly better as than that for idiopathic PAH. Nevertheless, overall survival of patients with PAH due to CHD was still markedly reduced compared with survival of patients with other types of CHD, despite an increasing number of patients on PAH-targeted combination therapy.
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http://dx.doi.org/10.3390/jcm9051456DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7290703PMC
May 2020

Transcatheter Aortic Valve Implantation in Patients With Pre-Existing Mechanical Mitral Valve Prostheses.

J Invasive Cardiol 2019 Sep;31(9):260-264

Herz- und Diabeteszentrum NRW, Clinic for General and Interventional Cardiology/Angiology, Georgstr. 11, D-32545 Bad Oeynhausen, Germany.

Objectives: Transcatheter aortic valve implantation (TAVI) has become standard therapy for aortic stenosis patients with intermediate or high operative risk. Treatment of patients with pre-existing mechanical mitral valve replacement (MVR) is challenging due to possible interference between the TAVI prosthesis and MVR. We present our single-center experience with this special patient cohort.

Methods: A total of 1960 patients underwent TAVI at our institution between 2009 and March 2018; of these, 16 patients had pre-existing mechanical MVR. Device success and adverse events were analyzed according to the Valve Academic Research Consortium (VARC)-2 criteria. Patients were followed for at least 12 months.

Results: Mean patient age was 81.5 ± 4.4 years. The patients had a mean logistic EuroScore of 37.1 ± 13.5% and STS score of 7.1 ± 3.2%. Successful valve deployment was achieved in all patients, peri-interventional stroke rate was 0.0%, and permanent pacemaker was implanted in 2 patients (12.5%). Two patients experienced major complications, with blockage of the MVR disc in 1 patient and annulus rupture in 1 patient. Hence, 30-day mortality was 12.5% and 1-year mortality was 25.0%.

Conclusion: TAVI in patients with mechanical MVR is challenging and requires careful preparation and choice of TAVI device. Repositionable and retrievable devices seem to be a safer option.
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September 2019

Feasibility of Transfemoral Aortic Valve Implantation in Patients With Aortic Disease and Simultaneous or Sequential Endovascular Aortic Repair.

J Invasive Cardiol 2019 Oct 15;31(10):289-295. Epub 2019 Aug 15.

Heart Center Bergmannsheil, Department of Cardiology and Angiology, Ruhr University Bochum, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany.

Objectives: The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF-TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR.

Methods: Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed.

Results: Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months.

Conclusion: TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.
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October 2019

Outcomes of left main revascularization in patients with acute coronary syndromes and stable ischemic heart disease: Analysis from the EXCEL trial.

Am Heart J 2019 08 4;214:9-17. Epub 2019 May 4.

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY. Electronic address:

Background: Prompt revascularization is often required in acute coronary syndromes (ACS), whereas stable ischemic heart disease (SIHD) may allow for more measured procedural planning. Whether the acuity of presentation preferentially affects outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with left main coronary artery disease (LMCAD) is unknown. We investigated whether the acuity of presentation discriminated patients who derived a differential benefit from PCI versus CABG in the randomized Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial.

Methods: We used multivariable Cox models to assess the interaction between the acuity of presentation, type of revascularization and outcomes in patients with low or intermediate SYNTAX scores enrolled in EXCEL.

Results: At baseline, 1151 patients (60.7%) presented with SIHD and 746 patients (39.3%) presented with an ACS. The acuity of presentation was not associated with the primary endpoint of all-cause death, MI, or stroke at 3 years (multivariable adjusted hazard ratio [HR] 0.94; 95% CI 0.70-1.26, P = .64). The primary endpoint rate was similar in patients assigned to PCI versus CABG whether they presented with SIHD (adjusted HR 1.04; 95% CI 0.73-1.48]) or with ACS (HR 0.82; 95% CI 0.54-1.26) (P = .34).

Conclusions: The acuity of presentation did not predict outcomes in patients with LMCAD undergoing revascularization, nor did it discriminate patients who derive greater event-free survival from PCI versus CABG.
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http://dx.doi.org/10.1016/j.ahj.2019.04.016DOI Listing
August 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

Minimally invasive versus transapical versus transfemoral aortic valve implantation: A one-to-one-to-one propensity score-matched analysis.

J Thorac Cardiovasc Surg 2018 11 5;156(5):1825-1834. Epub 2018 May 5.

Clinic of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.

Objectives: Although transcatheter aortic valve implantation was the treatment of choice in inoperable and high-risk patients, the effect of transcatheter aortic valve implantation relative to conventional aortic valve replacement via ministernotomy in patients with moderate surgical risk remains unclear.

Methods: We consecutively enrolled patients who underwent minimally invasive aortic valve replacements via ministernotomy (n = 1929), transapical (n = 607), and transfemoral (n = 1273) aortic valve implantations from a single center during the period from July 2009 to July 2017. Of those, we conducted a 1:1:1 propensity score matching according to 23 preoperative risk factors.

Results: We were able to find 177 triplets (n = 531). The median European System for Cardiac Operative Risk Evaluation II was 3.0% versus 3.4% versus 2.9%, and Society of Thoracic Surgeons Predicted Risk of Mortality was 3.2% versus 3.6% versus 3.4%, respectively. According to the Valve Academic Research Consortium 2 criteria, there were no significant periprocedural differences regarding 30-day mortality (2.3% minimally invasive aortic valve replacement vs 4.5% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P = .34), stroke (1.1% minimally invasive aortic valve replacement vs 0.6% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P = .84), or myocardial infarction (0.6% minimally invasive aortic valve replacement vs 0.0% transapical transcatheter aortic valve implantation vs 0.0% transfemoral transcatheter aortic valve implantation, P = .83). Both intensive care and hospitalization times were significantly longer in the transapical group. Regarding midterm survival, transapical transcatheter aortic valve implantation was associated with a tendency toward a less favorable outcome (hazard ratio, 1.48; 95% confidence interval, 0.95-2.31; P = .17) compared with minimally invasive aortic valve replacement.

Conclusions: In this real-world propensity score-matched minimally invasive aortic valve replacement, transapical transcatheter aortic valve implantation, transfemoral transcatheter aortic valve implantation cohort of intermediate-risk patients, early mortality was not significantly different, whereas the rates of periprocedural complications were different depending on the approach. During follow-up, there was a tendency in the transapical transcatheter aortic valve implantation group toward a less favorable survival outcome, although there was no significant difference among the 3 groups.
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http://dx.doi.org/10.1016/j.jtcvs.2018.04.104DOI Listing
November 2018

Repeated thrombolysis in a patient with a thrombosed tricuspid valve prosthesis.

Clin Res Cardiol 2018 Nov 9;107(11):1079-1081. Epub 2018 May 9.

Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

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http://dx.doi.org/10.1007/s00392-018-1271-xDOI Listing
November 2018

Delayed Coronary Obstruction After Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2018 04;71(14):1513-1524

Quebec Heart and Lung Institute, Quebec City, Quebec, Canada.

Background: Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR).

Objectives: The aim of this study was to describe the incidence and pathophysiological features of DCO after TAVR, obtained from a large international multicenter registry.

Methods: Data were retrospectively collected from an international multicenter registry consisting of 18 centers between November 2005 and December 2016.

Results: During the study period, 38 DCO (incidence 0.22%) cases were identified from a total of 17,092 TAVR procedures. DCO occurred more commonly after valve-in-valve procedures (0.89% vs. 0.18%; p < 0.001) and if self-expandable valves were used during the index procedure (0.36% vs. 0.11% balloon expandable; p < 0.01). DCO was most likely to occur ≤24 h after the TAVR procedure (47.4%; n = 18); 6 (15.8%) cases occurred between 24 h and ≤7 days, with the remaining 14 (36.8%) at ≥60 days. The most frequent presentation was cardiac arrest (31.6%; n = 12), followed by ST-segment elevation myocardial infarction (23.7%; n = 9). The left coronary artery was obstructed in most cases (92.1%; n = 35). Percutaneous coronary intervention was attempted in the majority of cases (74.3% left main; 60% right coronary), and stent implantation was successful in 68.8%. The overall in-hospital death rate was 50% (n = 19), and was higher if DCO occurred ≤7 days from the index procedure (62.5% vs. 28.6%; p = 0.09).

Conclusions: DCO following TAVR is a rare phenomenon that is associated with a high in-hospital mortality rate. Clinicians should be aware that coronary obstruction can occur after the original TAVR procedure and have a low threshold for performing coronary angiography when clinically suspected.
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http://dx.doi.org/10.1016/j.jacc.2018.01.066DOI Listing
April 2018

Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut R for degenerated small versus bigger bioprostheses.

J Interv Cardiol 2018 Jun 28;31(3):384-390. Epub 2018 Feb 28.

Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

Objectives: We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow-up in patients with degenerated bioprostheses.

Methods: From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow-up were entered into a dedicated database.

Results: Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1-year follow-up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013.

Conclusion: ViV-TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.
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http://dx.doi.org/10.1111/joic.12498DOI Listing
June 2018

Impact of procedure-related conduction disturbances after transcatheter aortic valve implantation on myocardial performance and survival evaluated by conventional and speckle tracking echocardiography.

Echocardiography 2018 05 13;35(5):621-631. Epub 2018 Feb 13.

Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

Objectives: Although procedure-related new cardiac conduction disturbances (CCDs) remain an important issue in transcatheter aortic valve implantation (TAVI), their effect on myocardial function and overall patient outcome remains unclear. The goal of this study was to analyze the influence of procedure-related CCDs on systolic and diastolic LV performance and on patient survival after TAVI.

Methods And Results: Ninety-five patients who underwent TAVI for severe symptomatic aortic stenosis (AS) and had a complete follow-up were evaluated with respect to procedure-related CCDs. Left ventricular (LV) performance was measured using standard echocardiographic parameters and speckle tracking analysis. Survival was assessed during longer-term follow-up (mean: 29.1 ± 16.9 months). After TAVI, the improvement of global LV function expressed as ejection fraction (LVEF; from 45.5 ± 10.0 to 47.8 ± 13.9%, P = .13) was not significant. New CCDs were found in 35.7% of TAVI recipients. A comparison between patients with and without new CCDs showed that LV systolic function improved in those without CCDs, while it tended to deteriorate in patients with CCDs (change in LVEF: 5.5 ± 12.3% vs -4.9% ± 11.5%, P = .001; change in global longitudinal strain (GLS): -1.1 ± 4.6% vs 1.2 ± 4.5%, P = .01). Changes in diastolic function did not differ significantly between the groups (changes in transmitral E/A-ratio: -0.3 ± 0.6 vs -0.5 ± 0.5, P = .1). Kaplan-Meier survival analysis revealed no significant differences between the two cohorts (P = .795).

Conclusion: Procedure-related conduction abnormalities after TAVI lead to an LBBB-related dyssynchrony with impairment of LV performance but not of overall survival.
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http://dx.doi.org/10.1111/echo.13823DOI Listing
May 2018

Impact of sheath diameter of different sheath types on vascular complications and mortality in transfemoral TAVI approaches using the Proglide closure device.

PLoS One 2017 24;12(8):e0183658. Epub 2017 Aug 24.

Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

Objective: Evaluation of the impact of the sheath diameter on vascular complications and mortality in transfemoral aortic valve implantation.

Method: Between 2012 and 2014, 183 patients underwent the procedure using a sheath diameter of 18-24 F. This collective was divided into two groups: group 1, with a sheath diameter of 18F (G1, n = 94), consisted of patients with 18F Medtronic Sentrant and 18 F Direct Flow sheaths, and group 2 with a sheath diameter of 19-24 F (G2, n = 89) consisted of patients with Edwards expandable e-sheath and Solopath sheaths. Perclose-Proglide® was used as a closure device in all patients.

Results: G1 had significantly more female patients (64.9% vs. 46.1% in G2, p = 0.01) and the average BMI was lower (26 ± 4.5% vs. 27.4 ± 4.7%, p = 0.03). There was no significant difference in the incidence of major and minor vascular complications (G1: 12.8% vs. G2: 12.4%, p = 0.9). 30-day mortality was similar in both groups (G1: 6.4 ± 2.5% [95% CI: 0.88-0.98], G2: 3.7 ± 1.9% [95% CI: 0.92-0.99]. The Kaplan Meier analysis of survival revealed no significant differences either.

Conclusion: The difference in sheath diameter had no effect on either incidence or severity of vascular complications. There was no impact on mortality either.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0183658PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5570351PMC
October 2017

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study.

J Am Coll Cardiol 2017 Aug;70(7):845-853

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

Background: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking.

Objectives: This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice.

Methods: The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents.

Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients.

Conclusions: TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
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http://dx.doi.org/10.1016/j.jacc.2017.06.045DOI Listing
August 2017

Transcatheter Aortic Valve Implantation in Nonagenarians: Procedural Outcome and Mid-Term Results.

Heart Lung Circ 2018 Jun 15;27(6):725-730. Epub 2017 Jun 15.

Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

Background: For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians.

Methods: From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians. In nonagenarians, mean age was 91.9±1.4years and compared to octogenarians showed a significantly higher logistic EuroScore (27.7±14.8% vs. 23.1±14.4, p=0.005) and STS Score (8.5±4.8% vs. 6.3±6.7, p=0.001).

Results: There were no significant differences with regard to stroke rate, pacemaker implantation rate and major vascular complications between the two groups. Thirty-day mortality was 9.8% in nonagenarians and 4.1% in octogenarians (p=0.04). At 1 year, all-cause mortality increased to 30.9% vs. 18.6% (n.s.).

Conclusion: Nonagenarians showed an increased periprocedural mortality during TAVI and higher mortality in follow-up compared to octogenarians. Age alone is not a predictive factor but indication for treatment should be carefully evaluated by the heart team on an individual basis.
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http://dx.doi.org/10.1016/j.hlc.2017.05.137DOI Listing
June 2018

Impact of closure devices on vascular complication and mortality rates in TAVI procedures.

Int J Cardiol 2017 Aug 15;241:133-137. Epub 2017 Jan 15.

Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

Background: Currently two closure devices are available for the vascular access in TAVI procedures. Their impact on vascular complications and mid-term mortality is yet unknown.

Methods: Between 2009 and 2014, 398 patients underwent TAVI TF procedures in which two different closure devices were used, Prostar® XL (n=215) and Perclose-Proglide® (n=183). In the cases with Prostar we used one device and in cases with Perclose-Proglide, two devices. The two groups were compared with respect to the criteria of the Valve Academic Research Consortium (VARC) II. The mean follow-up period was 679.7±481.8 (727) days.

Results: There were no significant differences in the baseline characteristics of both patient groups. In the Prostar® group, complications were more frequent (26.6% vs. 12.6%, p=0.005); in detail, these were bleeding (14.9% vs. 7.1%, [p]=0.02), suture rupture (4.7% vs. 1.3%, p=0.04), and pseudoaneurysms (10.2% vs. 1.2%, p<0.001). Multivariate regression analysis revealed two predictors for vascular complications: female sex (OR 2.3; 95% CI 1.3-3.8, p=0.002) and closure devices (OR 0.5; 95% CI 0.3-0.8, p=0.007) in favour of Proglide®. There was no significant difference in 30-day mortality (Prostar: 5.6±1.6% vs. Proglide: 4.9±1.6%). However, Kaplan-Meier survival analysis showed a significantly higher survival rate over the entire follow-up period for the Proglide® group (p=0.03).

Conclusion: Vascular complications occurred more often in the Prostar® group. Although 30-day mortality showed no significant difference between the groups, the mortality over complete follow-up was significantly lower in the Proglide® group.
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http://dx.doi.org/10.1016/j.ijcard.2017.01.088DOI Listing
August 2017

Left ventricular adaptation after TAVI evaluated by conventional and speckle-tracking echocardiography.

Int J Cardiol 2017 Feb 9;228:633-637. Epub 2016 Nov 9.

Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

Objective: Our study aimed to evaluate myocardial adaption and outcome after transfemoral aortic valve implantation (TAVI TF) for severe aortic stenosis by LV ejection fraction (LVEF) and speckle tracking analysis.

Methods And Results: From 168 patients who underwent TAVI TF between 2010 and 2013 in our institution, n=95 with a follow-up period ≥3months were included and grouped (G) according to baseline left ventricular ejection fraction (LVEF; G1: LVEF<40%, G2: 40%-55%, G3: >55%). LV function was evaluated using conventional and speckle-tracking based parameters. Mortality was tracked up to 60months. Aortic valve orifice diameter and mean aortic gradient improved significantly after TAVI. LV dimensions and LVEF remained largely unchanged. Systolic function significantly improved in G1 (LVEF, p<0.001, global longitudinal strain [GLS], p=0.02) but deteriorated in G3 (LVEF, p=0.004, GLS, p=0.03). It did not change in G2. Diastolic function parameters improved significantly only in G3. Changes of LVEF and GLS were also statistically significant between G1 and G3 (LVEF p<0.0001, GLS p=0.004). Patients exhibited a higher survival rate with an LVEF increase >8% than with LVEF deterioration >8% (p=0.04). GLS changes had no significant impact on mortality.

Conclusion: In patient with aortic stenosis and LVEF impairment at baseline, TAVI results in an improved LVEF, while patients with a high LVEF at baseline experience a normalization of LVEF after TAVI. Independent of the baseline value, a deterioration of LVEF leads to a significant increase in mortality.
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http://dx.doi.org/10.1016/j.ijcard.2016.11.035DOI Listing
February 2017

Pre-Capillary, Combined, and Post-Capillary Pulmonary Hypertension: A Pathophysiological Continuum.

J Am Coll Cardiol 2016 07;68(4):368-78

Clinic III for Internal Medicine (Cardiology), and Center for Molecular Medicine Cologne (CMMC), University of Cologne, Cologne, Germany; Cologne Cardiovascular Research Center (CCRC), University of Cologne, Cologne, Germany.

Background: Pulmonary hypertension (PH) is hemodynamically classified as pre-capillary (as seen in idiopathic pulmonary arterial hypertension [IPAH]) or post-capillary (as seen in heart failure with preserved ejection fraction [HFpEF]). Overlaps between these conditions exist. Some patients present with risk factors for left heart disease but pre-capillary PH, whereas patients with HFpEF may have combined pre- and post-capillary PH.

Objectives: This study sought to further characterize similarities and differences among patient populations with either PH-HFpEF or IPAH.

Methods: We used registry data to analyze clinical characteristics, hemodynamics, and treatment responses in patients with typical IPAH (<3 risk factors for left heart disease; n = 421), atypical IPAH (≥3 risk factors for left heart disease; n = 139), and PH-HFpEF (n = 226) receiving PH-targeted therapy.

Results: Compared with typical IPAH, patients with atypical IPAH and PH-HFpEF were older, had a higher body mass index, had more comorbidities, and had a lower 6-min walking distance, whereas mean pulmonary artery pressure (46.9 ± 13.3 mm Hg vs. 43.9 ± 10.7 mm Hg vs. 45.7 ± 9.4 mm Hg, respectively) and cardiac index (2.3 ± 0.8 l/min/m(2) vs. 2.2 ± 0.8 l/min/m(2) vs. 2.2 ± 0.7 l/min/m(2), respectively) were comparable among groups. After initiation of targeted PH therapies, all groups showed improvement in exercise capacity, functional class, and natriuretic peptides from baseline to 12 months, but treatment effects were less pronounced in patients with PH-HFpEF than typical IPAH; with atypical IPAH in between. Survival rates at 1, 3, and 5 years were almost identical for the 3 groups.

Conclusions: Patients with atypical IPAH share features of both typical IPAH and PH-HFpEF, suggesting that there may be a continuum between these conditions.
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http://dx.doi.org/10.1016/j.jacc.2016.05.047DOI Listing
July 2016

First Explantation of Direct Flow Medical Transcatheter Valve.

J Heart Valve Dis 2015 May;24(3):342-4

Next-generation transcatheter heart valves are designed to overcome procedure-related adverse events such as vascular complications and annulus rupture, and to minimize paravalvular regurgitation. The Direct Flow Medical valve is fully repositionable and shows promising results. The case is presented of Direct Flow Medical valve implantation in a patient with a functional bicuspid aortic valve. Multiple repositioning maneuvers failed to overcome the anatomic difficulties, and this resulted in a moderately high persisting gradient and moderate paravalvular leakage. Surgical valve explantation was necessary which, to the present authors' knowledge, is the first such case of Direct Flow Medical valve explantation to be performed.
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May 2015

Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation.

Eur Heart J Cardiovasc Imaging 2016 Dec 12;17(12):1385-1393. Epub 2016 Jan 12.

Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Georgstraße 11, Bad Oeynhausen 32545, Germany.

Aims: New-onset conduction disturbances still represent a considerable problem after transcatheter aortic valve implantation (TAVI). The aim of this study was to identify calcification patterns with an elevated risk for permanent pacemaker implantation (PPI) after TAVI and investigate underlying mechanisms in an ex vivo setting.

Methods And Results: One hundred and sixty-two patients who underwent TAVI with the Edwards SAPIEN XT or Medtronic CoreValve at our institution were analysed. The calcium load of the device landing zone was quantified with 3mensio, and calcium patterns with an elevated risk for PPI were identified. Ex vivo simulations of balloon valvuloplasty were performed in 3D-printed silicone annuli of patients matching the identified risk profile. Patients with a calcium load of the left coronary cusp (LCC) above 209 mm had a higher rate of PPI than patients below this threshold (16.7 vs. 2.6%, P = 0.003). Multivariate regression revealed pre-existing right bundle branch block (RBBB) and increased LCC calcification as independent predictors for PPI. Simulation of the TAVI procedure in a silicone annulus revealed an off-centreline shift of the valvuloplasty balloon and transcatheter heart valve away from the LCC towards the commissure between right- and non-coronary cusp.

Conclusion: Pre-existing RBBB and elevated LCC calcification were identified as independent predictors for PPI. These two risk factors enabled us to distinguish between patients according to their risk for PPI after TAVI. Ex vivo simulations suggested an off-centreline shift of the balloon as a possible explanation.
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http://dx.doi.org/10.1093/ehjci/jev343DOI Listing
December 2016

Prosthetic Valve Escaping During Transcatheter Aortic Valve Implantation.

Innovations (Phila) 2015 Nov-Dec;10(6):425-7

From the Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany.

We performed transapical transcatheter aortic valve implantation on an 87-year-old woman with severe aortic valve stenosis. Because of the narrow left ventricular outflow tract, annular positioning of the prosthetic valve proved challenging. During positioning, the prosthetic valve was accidentally dislodged from the balloon catheter and dropped into the left ventricle. Attempted catheter retrieval was unsuccessful. We therefore converted to open surgery without delay. After aortotomy, to our surprise, the prosthesis could not be found, neither in the left ventricle nor in the ascending aorta. Transesophageal echocardiography failed to reveal the location of the missing prosthesis. Fluoroscopy finally displayed the prosthesis in the descending aorta at the level of the left atrium. We proceeded with aortic and mitral valve replacement and closed the sternum. Under fluoroscopic guidance, the prosthetic valve was secured to the wall of the abdominal aorta in an infrarenal position by dilatation with a balloon catheter. This case shows that we should be alert to septum hypertrophy or a narrow left ventricular outflow tract during transapical aortic valve implantation. In such anatomical situations, we recommend advancing the sheath of the application system directly below the annular plane and positioning the prosthesis from this point.
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http://dx.doi.org/10.1097/IMI.0000000000000210DOI Listing
October 2016

Interventional ASD II closure in the presence of an abnormally localized left main coronary artery.

Clin Res Cardiol 2016 Feb 1;105(2):182-5. Epub 2015 Oct 1.

Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Georgstr. 11, D-32545, Bad Oeynhausen, Germany.

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http://dx.doi.org/10.1007/s00392-015-0923-3DOI Listing
February 2016

In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

Innovations (Phila) 2015 Jul-Aug;10(4):276-8

From the Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany.

An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.
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http://dx.doi.org/10.1097/IMI.0000000000000173DOI Listing
June 2016

Device landing zone calcification and its impact on residual regurgitation after transcatheter aortic valve implantation with different devices.

Eur Heart J Cardiovasc Imaging 2016 May 9;17(5):576-84. Epub 2015 Jul 9.

Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.

Aims: Calcification of the device landing zone is linked to paravalvular regurgitation after transcatheter aortic valve implantation (TAVI). The mechanisms remain incompletely understood and the performance of next-generation transcatheter heart valves (THV) has not been investigated. We evaluated the impact of calcification patterns on residual aortic regurgitation (AR) after TAVI with different THV in patients with severe aortic stenosis.

Methods And Results: TAVI was performed in 537 patients at two centres. Devices implanted were the Edwards Sapien XT (n = 254), Medtronic CoreValve (n = 123), JenaValve (n = 62), Medtronic Engager (n = 56), and Symetis Acurate (n = 42) prostheses. Calcification of the device landing zone was retrospectively assessed from contrast-enhanced multidetector computed tomography data and correlated with echocardiographic and clinical data. Calcium volumes of the aortic valve and left-ventricular outflow tract were associated with residual AR: No AR, 604 mm(3) (inter-quartile range, IQR 349-916); trace AR, 639 mm(3) (IQR 368-948); mild AR, 710 mm(3) (IQR 412-2078); ≥moderate AR, 1041 mm(3) (IQR 791-1417, P = 0.001). Device landing zone calcium, particularly if located in the left-ventricular outflow tract, and a low cover index were predictive of AR. Differences in the incidence of AR were observed with regard to THV type. Higher calcium volume was associated with the need for post-dilation (n = 134, median 852 [IQR 342-945] vs. 604 [IQR 542-1207] mm(3), P < 0.001).

Conclusion: Calcification of the device landing zone, particularly if located inferior to the annulus, was independently associated with residual AR after TAVI with all evaluated THV; however, the incidence of paravalvular leakage differed significantly between the devices implanted.
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http://dx.doi.org/10.1093/ehjci/jev174DOI Listing
May 2016

Uncommon intracardiac finding after cardiac transplantation mimicking pacemaker leads.

Eur Heart J Cardiovasc Imaging 2015 May 31;16(5):571. Epub 2014 Dec 31.

Department of Cardiovascular Surgery, Heart and Cardiovascular Centre North Rhine-Westphalia, Ruhr University Bochum, Georgstr. 11, Bad Oeynhausen 32545, Germany.

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http://dx.doi.org/10.1093/ehjci/jeu303DOI Listing
May 2015

A differentiated morphological parameter-coding system to describe the suitability of mitral valve stenoses intended for percutaneous valvotomy.

Heart Vessels 2015 Sep 27;30(5):632-41. Epub 2014 Jun 27.

Department of Cardiology, Heart Center North Rhine-Westphalia, Ruhr University Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany.

Percutaneous balloon-mitral-valvotomy (PBMV) is an alternative to surgery in selected patients with mitral valve (MV) stenosis (MS). Applying echocardiography, suitability for PBMV is assessed by detailed morphological description. Echo-scores alone are suboptimal to describe MV morphology, because single parameters, important for a decision concerning PBMV, are not distinguishable out of a score number. The aim was to design a tool (coding-system), which combines a number for a stenotic MV like scores (for statistical options) and decodable, generally applied parameters describing the MS morphology. The reproducibility of the MS morphology using the coding-system has to be tested in 90 patients. A separate group of 297 patients (pts) with MS, scheduled for PBMV, should be investigated prospectively applying the coding-system and a comparable score. We chose the Wilkins score (WS) as representative of scores. The coding-system is designed as a parameter sequencing set consisting of 6 digits. The first digit indicates a decision code concerning suitability for PBMV. The following 5 digits indicate generally accepted morphological parameters, which are partially also used in the WS. Therefore, the MS morphology can be "read" retrospectively by decoding. 201/297 patients were found suitable for PBMV. Applying the coding-system all 201 suitable patients were correctly distinguished from 96 morphologically unsuitable patients. Astonishingly 48/96 of the rejected patients showed a WS ≤8 whereas 28/201 of the suitable patients demonstrated a WS >8. 25/28 of them showed a successful initial outcome. Applying the generally known threshold of "8" when predicting suitability of a MS, the WS demonstrated an initial success rate of 62 %, sensitivity of 0.87, specificity of 0.45, precision of 0.79, and accuracy of 0.78. Applying the coding-system, the initial success rate was 70.8 %, sensitivity = 0.96, specificity = 1.0, precision = 1.0, and accuracy = 0.97. The coding-system is an advanced diagnostic aid, is statistically applicable, offers a decodable morphological description, includes a decision code regarding suitability for PBMV, and can be used for comparing different groups of patients with MS by calculating "mean morphologies" of groups.
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http://dx.doi.org/10.1007/s00380-014-0536-1DOI Listing
September 2015

Transfemoral aortic valve-in-valve implantation with the CoreValve Evolut for small degenerated stented bioprosthesis.

J Invasive Cardiol 2014 Jun;26(6):291-4

Heart and Diabetes Center North Rhine-Westphalia, Department of Cardiology, Georgstr. 11, D-32545 Bad Oeynhausen, Germany.

Transcatheter aortic valve-in-valve implantation represents one interesting therapeutic option for high-risk surgical patients with degenerated bioprostheses. The procedure is less invasive and can be performed without thoracotomy and general anesthesia, if the femoral approach is used. Until recently, failing small bioprostheses could only be treated percutaneously by underexpanding the CoreValve (Medtronic, Inc) or Edwards Sapien valve (Edwards Lifesciences). Underexpansion of these valves might compromise the hemodynamic performance and potentially limit its durability. Herein, we report our initial experience with the 23 mm CoreValve Evolut in 4 patients with degenerated 21 mm Mitroflow valves. The CoreValve prosthesis was successfully implanted in all 4 patients, with no major complications and no mortality at 3-month follow-up exam. However, 2 of the 4 patients developed mildly elevated transvalvular gradients. Therefore, despite our promising results, caution is necessary when considering patients with small degenerated bioprostheses for a valve-in-valve procedure.
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June 2014

Delayed coronary ischemia after transfemoral aortic valve implantation.

J Heart Valve Dis 2013 Nov;22(6):762-6

Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.

Transcatheter aortic valve implantation (TAVI) offers a less invasive treatment alternative to surgical aortic valve replacement for high-risk patients. Although the procedure can be performed at low risk, life-threatening complications may arise in single cases during or even months after the procedure. Here, the details are presented of two patients who underwent TAVI by a transfemoral approach with Medtronic CoreValve prostheses and suffered myocardial ischemia months later. The patients' anatomy with small aortic root, narrow sinus of Valsalva and small distance between the annulus base and coronary arteries and/or the relative oversizing of the CoreValve prosthesis with a high positioning may have contributed to this late complication. Hence, caution is mandatory in this type of patient, with exact pre-procedural planning and close follow up required.
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November 2013

Patent foramen ovale closure challenged by left atrial chord.

J Am Coll Cardiol 2014 Feb 27;63(5):490. Epub 2013 Nov 27.

Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.

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http://dx.doi.org/10.1016/j.jacc.2013.07.116DOI Listing
February 2014

Intermediate follow-up results from the multicenter engager European pivotal trial.

Ann Thorac Surg 2013 Dec 7;96(6):2095-100. Epub 2013 Sep 7.

Department of Cardiovascular Surgery and Department of Internal Medicine/Cardiology, Heart Center Leipzig, Leipzig, Germany. Electronic address:

Background: Optimal transcatheter aortic valve (TAVI) results require accurate valve positioning, including anatomically correct orientation and secure fixation within the aortic annulus, thereby potentially decreasing paravalvular regurgitation. The new Engager (Medtronic 3F Therapeutics, Santa Ana, CA) transapical valve system captures the native leaflets for sealing and allows for tactile feedback during valve placement. We report initial safety and performance outcomes of the Engager system through 6 months in patients with severe aortic valve stenosis at high risk for surgical aortic valve replacement.

Methods: An interim analysis was performed on the first 61 enrolled September 2011 through May 2012. Inclusion criteria comprised severe aortic stenosis, New York Heart Association functional class of II or greater, logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 20% or greater, or contraindication to surgical aortic valve replacement. The primary endpoint was all-cause mortality at 30 days. Patients were evaluated 24 to 48 hours post-procedure, at hospital discharge, 30 days and 6 months. Follow-up is planned annually through five years.

Results: Baseline characteristics for the 61 patients were mean age 81.9 ± 4.4 years, 62.3% female, 88.5% New York Heart Association class III/IV, 52.5% coronary artery disease, and 54.2% extracardiac arteriopathy. For all of the attempted implantations (n = 60), the Engager prosthesis was positioned in the correct anatomic position without conversions to surgery, second valve implantation, device malposition, aortic annular rupture, or coronary obstruction. All-cause mortality was 9.9% at 30 days and 16.9% at 6 months. The baseline mean aortic valve gradient was 43.7 ± 16.7 mm Hg and 11.5 ± 5.0 mm Hg at 30 days, and showed similar reduction at 6 months (13.9 ± 6.2 mm Hg). There was no paravalvular regurgitation greater than mild through 6 months.

Conclusions: Early postoperative results support implantation success and valve safety. Analysis for 6 month outcomes shows stable hemodynamic performance and clinical outcome. (Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System-the Engager European Pivotal Trial; NCT01348438).
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http://dx.doi.org/10.1016/j.athoracsur.2013.06.089DOI Listing
December 2013
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