Publications by authors named "Roman Pfister"

168 Publications

Transcatheter Treatment of Secondary Tricuspid Regurgitation With Direct Annuloplasty: Results From a Multicenter Real-World Experience.

Circ Cardiovasc Interv 2021 Jul 30:CIRCINTERVENTIONS120010019. Epub 2021 Jul 30.

Department of Internal Medicine III, Division of Cardiology, Pneumology, Angiology and Intensive Care, University of Cologne, Germany (M.I.K., S.B., R.P.).

Background: Treatment options for secondary tricuspid regurgitation (TR) remain limited. Early real-world data of a new percutaneous direct annuloplasty system for tricuspid repair were examined.

Methods: The first 60 patients treated with the Cardioband tricuspid valve repair system at 4 centers were included in this retrospective study. The primary efficacy end point was technical success with reduction of TR ≥2 grades at discharge. Combined primary safety end point was major adverse events (death, myocardial infarction, cardiothoracic surgery, and stroke) at 30 days.

Results: Median patient age was 76 years (73-82), median EuroScore II was 3.9% (2.2-8.1), heart failure with preserved ejection fraction was present in 78%, and 81.7% were in the New York Heart Association class III/IV. Massive or torrential TR was found in 51.7%, and severe TR in 48.3%. The primary efficacy end point was achieved in 45%, while 60.3% of patients had less-than-severe TR at discharge. Vena contracta was reduced by 47% from 12.9±4.8 to 7.0±3.4 mm (<0.001). Overall, the majority of patients (81.7%) improved at least by 1 New York Heart Association class. At follow-up 81.3% of patients presented in the New York Heart Association class I or II. The primary safety end point occurred in 4 patients with 2 in-hospital deaths, both not device related. Right coronary artery complications (vessel perforation or stent implantation) occurred in 9 patients (15%). Procedural time decreased from 298 to 185 minutes (<0.001) with efficacy remaining stable (=0.817) when comparing procedure numbers 11 or more to the earliest 5 procedures per center.

Conclusions: This first real-world experience suggests that transcatheter treatment of advanced secondary TR using direct annuloplasty is feasible and reasonably safe early in the learning curve, with significant symptomatic benefit. Further studies are warranted to provide data on long-term outcome and patient prognosis.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010019DOI Listing
July 2021

Risk Stratification of Patients Undergoing Percutaneous Repair of Mitral and Tricuspid Valves Using a Multidimensional Geriatric Assessment.

Circ Cardiovasc Qual Outcomes 2021 Jul 30:CIRCOUTCOMES120007624. Epub 2021 Jul 30.

Division of Cardiology, Pneumology, Angiology, and Intensive Care, Department III of Internal Medicine (M.S., M.I.K., R.V., V.M., C.I., C.M., H.t.F., S.B., R.P.), Faculty of Medicine and University Hospital Cologne, University of Cologne, Germany.

Background: Given their advanced age and high comorbidity, individual risk assessment is crucial in patients undergoing transcatheter mitral and tricuspid valve repair. Therefore, we evaluated the use of a comprehensive geriatric assessment score, the multidimensional prognostic index (MPI), for risk stratification in these patients.

Methods: We conducted a prospective, observational single-center study, including 226 patients undergoing percutaneous repair for mitral or tricuspid regurgitation. The MPI was calculated preprocedural and covers 8 domains (activities of daily living, instrumental activities of daily living, mental status, nutrition, risk of pressure ulcers, comorbidity, medication, and marital/cohabitation status). We sought to identify an association of MPI score with procedural outcomes and 6-month mortality.

Results: A total of 53.1% of patients were stratified as low risk according to MPI (MPI-1 group), 44.2% as medium risk (MPI-2 group), and 2.7% as high risk (MPI-3 group). Procedural efficacy and safety were similar between groups. The estimated survival rate at 6 months was 97±2% in MPI-1 group, 79±4% in MPI-2 group (hazard ratio, 6.90 [95% CI, 2.36-12.2]; ≤0.001) and 50±20% in MPI-3 group (hazard ratio, 20.3 [95% CI, 4.51-91.3]; <0.001). An increase in 1 SD of the MPI score (0.14 points, possible range of MPI score 0-1) was associated with a hazard ratio of 2.13 (95% CI, 1.58-2.73; ≤0.001) for death after 6 months. The risk association of the MPI with mortality remained significant in multivariate analysis including risk factors, such as peripheral artery disease and NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels.

Conclusions: A comprehensive geriatric assessment with the MPI score provides additional information on mortality risk beyond established cardiovascular risk factors.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007624DOI Listing
July 2021

Impact of Atrial Fibrillation on Outcome in Takotsubo Syndrome: Data From the International Takotsubo Registry.

J Am Heart Assoc 2021 Jul 28:e014059. Epub 2021 Jul 28.

Department of Cardiology Intensive Care Medicine and Angiology Vincentius-Diakonissen-Hospital Karlsruhe Germany.

Background Atrial fibrillation (AF) is a major risk factor for mortality. The prevalence, clinical correlates, and prognostic impact of AF in Takotsubo syndrome (TTS) have not yet been investigated in a large patient cohort. This study aimed to investigate the prevalence, clinical correlates, and prognostic impact of AF in patients with TTS. Methods and Results Patients with TTS were enrolled from the International Takotsubo Registry, which is a multinational network with 26 participating centers in Europe and the United States. Patients were dichotomized according to the presence or absence of AF at the time of admission. Of 1584 patients with TTS, 112 (7.1%) had AF. The mean age was higher (<0.001), and there were fewer women (=0.046) in the AF than in the non-AF group. Left ventricular ejection fraction was significantly lower (=0.001), and cardiogenic shock was more often observed (<0.001) in the AF group. Both in-hospital (<0.001) and long-term mortality (<0.001) were higher in the AF group. Multivariable Cox regression analysis revealed that AF was independently associated with higher long-term mortality (hazard ratio, 2.31; 95% CI, 1.50-3.55; <0.001). Among patients with AF on admission, 42% had no known history of AF before the acute TTS event, and such patients had comparable in-hospital and long-term outcomes compared with those with a history of AF. Conclusions In patients presenting with TTS, AF on admission is significantly associated with increased in-hospital and long-term mortality rates. Whether antiarrhythmics and/or cardioversion are beneficial in TTS with AF should thus be tested in a future trial. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01947621.
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http://dx.doi.org/10.1161/JAHA.119.014059DOI Listing
July 2021

Clinical deterioration after implantation of an interatrial shunt device: case report of an unexpected aetiology.

Eur Heart J Case Rep 2021 Feb 8;5(2):ytab009. Epub 2021 Feb 8.

Department of Cardiology, Heart Center, University of Cologne, Kerpener Str. 62, D-50937, Cologne, Germany.

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http://dx.doi.org/10.1093/ehjcr/ytab009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276606PMC
February 2021

Prognostic value of hepatorenal function following transcatheter edge-to-edge mitral valve repair.

Clin Res Cardiol 2021 Jul 12. Epub 2021 Jul 12.

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.

Background: Hepatorenal dysfunction is a strong prognostic predictor in patients with heart failure. However, the prognostic impact of the hepatorenal dysfunction in patients undergoing transcatheter mitral valve repair (TMVR) has not been well studied.

Methods: In consecutive patients who underwent edge-to-edge TMVR at three German centers, the model for end-stage liver disease excluding international normalized ratio (MELD-XI) score was calculated as 5.11 × ln [serum total bilirubin (mg/dl)] + 11.76 × ln [serum creatinine (mg/dl)] + 9.44. Patients were stratified into high (> 11) or low (≤ 11) MELD-XI score of which an incidence of the composite outcome, consisting of all-cause mortality and heart failure hospitalization, within 2 years after TMVR was assessed.

Results: Of the 881 patients, the mean MELD-XI score was 11.0 ± 5.9, and 415 patients (47.1%) had high MELD-XI score. The MELD-XI score was correlated with male, effective regurgitant orifice area, and tricuspid regurgitation severity and inversely related to left ventricular ejection fraction. Patients with high MELD-XI score had a higher incidence of the composite outcome than those with low MELD-XI score (47.7% vs. 29.8%; p < 0.0001), and in multivariable analysis, the high MELD-XI score was an independent predictor of the composite outcome [adjusted hazard ratio (HR) 1.34; 95% confidence interval (CI) 1.02-1.77; p = 0.04). Additionally, the MELD-XI score as a continuous variable was also an independent predictor (adjusted HR 1.02; 95% CI 1.00-1.05; p = 0.048).

Conclusions: The MELD-XI score was associated with clinical outcomes within 2 years after TMVR and can be a useful risk-stratification tool in patients undergoing TMVR.
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http://dx.doi.org/10.1007/s00392-021-01908-wDOI Listing
July 2021

Rationale and design of the EPCHF trial: the early palliative care in heart failure trial (EPCHF).

Clin Res Cardiol 2021 Jul 9. Epub 2021 Jul 9.

Department of Cardiology, Angiology, Pneumology and Medical Intensive Care, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.

The progressive nature of heart failure (HF) coupled with high mortality and poor quality-of-life (QoL) mandates greater attention to palliative care (PC) as a routine component of HF management. Limited evidence exists from randomized controlled trials supporting the use of interdisciplinary palliative care in the progressive course of HF. The early palliative care in heart failure trial (EPCHF) is a prospective, controlled, nonblinded, multicenter study of an interdisciplinary palliative care intervention in 200 patients with symptomatic HF characterized by NYHA ≥ 2. The 12-month EPCHF intervention includes monthly consultations by a palliative care team focusing on physical and psychosocial symptom relief, attention to spiritual concerns and advance care planning. The primary endpoint is evaluated by health-related QoL questionnaires after 12 months of treatment. First the functional assessment of chronic illness therapy palliative care (FACIT-Pal) score evaluating QoL living with a chronic disease and second the Kansas City cardiomyopathy questionnaire (KCCQ) measuring QoL living with heart failure will be determined. Secondary endpoints are changes in anxiety/depression (HADS), symptom burden score (MIDOS), spiritual well-being functional assessment of chronic illness therapy spiritual well-being scale (FACIT-Sp), medical resource and cost assessment. EPCHF will help evaluate the efficacy and cost-effectiveness of palliative care in symptomatic HF using a patient-centered outcome as well as clinical and economic endpoints. EPCHF is funded by the Bundesministerium für Bildung und Forschung (BMBF, 01GY17).
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http://dx.doi.org/10.1007/s00392-021-01903-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8266990PMC
July 2021

Mitral Regurgitation International Database (MIDA) Score Predicts Outcome in Patients With Heart Failure Undergoing Transcatheter Edge-to-Edge Mitral Valve Repair.

J Am Heart Assoc 2021 Jul 30;10(13):e019548. Epub 2021 Jun 30.

Department of Internal Medicine II University Hospital Bonn Bonn Germany.

Background Optimizing risk stratification in patients undergoing transcatheter mitral valve repair is an ongoing challenge. The Mitral Regurgitation International Database (MIDA) score represents a user-friendly mortality risk stratification tool that is validated on a large-scale registry of patients with degenerative mitral regurgitation (MR). We here assessed the potential benefit of the MIDA risk score for patients with functional or degenerative MR undergoing transcatheter mitral valve repair. Methods and Results In total, 680 patients undergoing MitraClip implantation were stratified according to MIDA score tertiles into a low (0-7), intermediate (8-9), and a high (10-12) MIDA score group. MR was assessed in follow-up echocardiograms in 416 patients at 323±169 days after transcatheter mitral valve repair. During 2-year follow-up, 8.2% (15/182) of patients with low, 21.3% (64/300) with intermediate, and 26.3% (52/198) with high MIDA score died (log-rank test <0.001). Hazard of all-cause mortality increased by 13% (95% CI, 3%-25%) with every additional point of the MIDA score. Subanalysis of 431 patients with functional MR showed similar results. Furthermore, rates of a combined end point of mortality and hospitalization for heart failure were higher with increasing MIDA score (30% [54/182], 38% [113/300] and 48% [94/198], respectively, log-rank test =0.001). Frequency of residual MR ≥II at follow-up increased with increasing MIDA score group (33%, 44%, and 59%, respectively, <0.001). Conclusions The MIDA mortality risk score maintains its predictive utility in patients undergoing transcatheter mitral valve repair, regardless of MR cause. Moreover, it was predictive of worse event-free survival regarding a combined end point of mortality and hospitalization for heart failure, and was associated with postprocedural residual MR ≥II and MR recurrence.
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http://dx.doi.org/10.1161/JAHA.120.019548DOI Listing
July 2021

Periinterventional inflammation and blood transfusions predict postprocedural delirium after percutaneous repair of mitral and tricuspid valves.

Clin Res Cardiol 2021 Jun 1. Epub 2021 Jun 1.

Department of Internal Medicine III, Division of Cardiology, Pneumology, Angiology and Intensive Care, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

Objectives: The aim of this study was to examine predictors and impact of postoperative delirium (POD) on outcome after percutaneous repair of mitral and tricuspid valves.

Background: POD is common in elderly patients and contributes to increased health care costs and worse outcome. Predictors of POD in percutaneous mitral or tricuspid valve procedures are unclear.

Methods: In a prospective single-center study, patients were screened for POD using the Confusion Assessment Method on the first and second postprocedural days, and up until 7 days in patients with clinical suspicion of delirium. Associations of POD with baseline characteristics, periprocedural outcome and mid-term mortality were examined.

Results: One hundred and seventy-seven patients were included (median age 78 years [72-82], 41.8% female) and median (IQR) follow-up was 489 (293-704) days. Patients developing POD (n = 16, 9%) did not differ in baseline and procedural characteristics but more often received postinterventional blood transfusions (37.5% vs. 9.9%, p value = 0.007) and suffered from infections (43.8% vs. 9.9%, p value = 0.001). Patients with POD showed worse survival (HR: 2.71 [1.27-5.78]; p = 0.01), with an estimated 1-year survival of 46 ± 13% compared to 80 ± 3% in patients without POD (log-rank p value 0.007). In multivariate Cox regression, POD remained a significant predictor of mid-term mortality (HR 4.75 [1.97-11.5]; p = 0.001).

Conclusion: After percutaneous mitral or tricuspid valve repair, POD was independently associated with worse mid-term survival. Procedure- rather than patient-associated characteristics such as blood transfusions and infections emerged as important risk factors for development of POD. Considering the substantial prognostic impact of POD, further studies on its prevention are warranted to improve patient outcome.
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http://dx.doi.org/10.1007/s00392-021-01886-zDOI Listing
June 2021

Ethnic comparison in takotsubo syndrome: novel insights from the International Takotsubo Registry.

Clin Res Cardiol 2021 May 19. Epub 2021 May 19.

Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.

Background: Ethnic disparities have been reported in cardiovascular disease. However, ethnic disparities in takotsubo syndrome (TTS) remain elusive. This study assessed differences in clinical characteristics between Japanese and European TTS patients and determined the impact of ethnicity on in-hospital outcomes.

Methods: TTS patients in Japan were enrolled from 10 hospitals and TTS patients in Europe were enrolled from 32 hospitals participating in the International Takotsubo Registry. Clinical characteristics and in-hospital outcomes were compared between Japanese and European patients.

Results: A total of 503 Japanese and 1670 European patients were included. Japanese patients were older (72.6 ± 11.4 years vs. 68.0 ± 12.0 years; p < 0.001) and more likely to be male (18.5 vs. 8.4%; p < 0.001) than European TTS patients. Physical triggering factors were more common (45.5 vs. 32.0%; p < 0.001), and emotional triggers less common (17.5 vs. 31.5%; p < 0.001), in Japanese patients than in European patients. Japanese patients were more likely to experience cardiogenic shock during the acute phase (15.5 vs. 9.0%; p < 0.001) and had a higher in-hospital mortality (8.2 vs. 3.2%; p < 0.001). However, ethnicity itself did not appear to have an impact on in-hospital mortality. Machine learning approach revealed that the presence of physical stressors was the most important prognostic factor in both Japanese and European TTS patients.

Conclusion: Differences in clinical characteristics and in-hospital outcomes between Japanese and European TTS patients exist. Ethnicity does not impact the outcome in TTS patients. The worse in-hospital outcome in Japanese patients, is mainly driven by the higher prevalence of physical triggers.

Trial Registration: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT01947621.
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http://dx.doi.org/10.1007/s00392-021-01857-4DOI Listing
May 2021

Impact of Residual Mitral Regurgitation on Survival After Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation.

JACC Cardiovasc Interv 2021 Jun 12;14(11):1243-1253. Epub 2021 May 12.

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; Munich Heart Alliance, Partner Site German Center for Cardiovascular Disease, Munich, Germany. Electronic address:

Objectives: The aim of this study was to assess the impact of residual mitral regurgitation (resMR) on mortality with respect to left ventricular dilatation (LV-Dil) or right ventricular dysfunction (RV-Dys) in patients with secondary mitral regurgitation (SMR) who underwent mitral valve transcatheter edge-to-edge repair (TEER).

Background: The presence of LV-Dil and RV-Dys correlates with advanced stages of heart failure in SMR patients, which may impact the outcome after TEER.

Methods: SMR patients in a European multicenter registry were evaluated. Investigated outcomes were 2-year all-cause mortality and improvement in New York Heart Association functional class with respect to MR reduction, LV-Dil (defined as LV end-diastolic volume ≥159 ml), and RV-Dys (defined as tricuspid annular plane systolic excursion-to-systolic pulmonary artery pressure ratio of <0.274 mm/mm Hg).

Results: Among 809 included patients, resMR ≤1+ was achieved in 546 (67%) patients. Overall estimated 2-year mortality rate was 32%. Post-procedural resMR was significantly associated with mortality (p = 0.031). Although the improvement in New York Heart Association functional class persisted regardless of either LV-Dil or RV-Dys, the beneficial treatment effect of resMR ≤1+ on 2-year mortality was observed only in patients without LV-Dil and RV-Dys (hazard ratio: 1.75; 95% confidence interval: 1.03 to 3.00).

Conclusions: Achieving optimal MR reduction by TEER is associated with improved survival in SMR patients, especially if the progress in heart failure is not too advanced. In SMR patients with advanced stages of heart failure, as evidenced by LV-Dil or RV-Dys, the treatment effect of TEER on symptomatic improvement is maintained, but the survival benefit appears to be reduced.
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http://dx.doi.org/10.1016/j.jcin.2021.03.050DOI Listing
June 2021

Sex-Related Clinical Characteristics and Outcomes of Patients Undergoing Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation.

JACC Cardiovasc Interv 2021 Apr 31;14(8):819-827. Epub 2021 Mar 31.

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; Munich Heart Alliance, Partner Site German Center for Cardiovascular Disease (DZHK), Munich, Germany. Electronic address:

Objectives: The authors sought to assess sex-based differences in characteristics and outcomes of patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for secondary mitral regurgitation (SMR).

Background: Subgroup analysis from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial indicated potential sex-related differences in outcomes after TMVR. The impact of sex on results after TMVR in a real-world setting is unknown.

Methods: The authors assessed clinical outcomes and echocardiographic parameters in women and men undergoing TMVR for SMR between 2008 and 2018 who were included in the large, international, multicenter real-world EuroSMR registry (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation).

Results: A total of 1,233 patients, including 445 women (36%) and 788 men (64%), were analyzed. Although women were significantly older and had fewer comorbidities than men, TMVR was equally effective in women and men (mitral regurgitation [MR] grade ≤2+ at discharge: 93.2% vs. 94.6% for women vs. men; p = 0.35). All-cause mortality at 1 year (17.9% vs. 18.9%, adjusted hazard ratio: 0.806; p = 0.46) and at 2-year follow-up (26.5% vs. 26.4%, adjusted hazard ratio: 0.757; p = 0.26) were similar in women versus men after multivariate regression analysis. Durability of MR reduction, improvement in symptoms, quality of life, and functional capacity did also not differ during follow-up.

Conclusions: Results from the EuroSMR registry confirmed effective and similar MR reduction with TMVR in women and men. There were no sex-related differences in clinical outcomes up to 2 years of follow-up.
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http://dx.doi.org/10.1016/j.jcin.2020.12.042DOI Listing
April 2021

Prognostic impact of acute pulmonary triggers in patients with takotsubo syndrome: new insights from the International Takotsubo Registry.

ESC Heart Fail 2021 06 13;8(3):1924-1932. Epub 2021 Mar 13.

Department of Cardiology, Charité, Campus Rudolf Virchow, Berlin, Germany.

Aims: Acute pulmonary disorders are known physical triggers of takotsubo syndrome (TTS). This study aimed to investigate prevalence of acute pulmonary triggers in patients with TTS and their impact on outcomes.

Methods And Results: Patients with TTS were enrolled from the International Takotsubo Registry and screened for triggering factors and comorbidities. Patients were categorized into three groups (acute pulmonary trigger, chronic lung disease, and no lung disease) to compare clinical characteristics and outcomes. Of the 1670 included patients with TTS, 123 (7%) were identified with an acute pulmonary trigger, and 194 (12%) had a known history of chronic lung disease. The incidence of cardiogenic shock was highest in patients with an acute pulmonary trigger compared with those with chronic lung disease or without lung disease (17% vs. 10% vs. 9%, P = 0.017). In-hospital mortality was also higher in patients with an acute pulmonary trigger than in the other two groups, although not significantly (5.7% vs. 1.5% vs. 4.2%, P = 0.13). Survival analysis demonstrated that patients with an acute pulmonary trigger had the worst long-term outcome (P = 0.002). The presence of an acute pulmonary trigger was independently associated with worse long-term mortality (hazard ratio 2.12, 95% confidence interval 1.33-3.38; P = 0.002).

Conclusions: The present study demonstrates that TTS is related to acute pulmonary triggers in 7% of all TTS patients, which accounts for 21% of patients with physical triggers. The presence of acute pulmonary trigger is associated with a severe in-hospital course and a worse long-term outcome.
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http://dx.doi.org/10.1002/ehf2.13165DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8120351PMC
June 2021

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

Clin Res Cardiol 2021 May 4;110(5):732-739. Epub 2021 Mar 4.

Medizinische Klinik und Poliklinik I, Ludwig Maximilians Universität München, Munich, Germany.

Objectives: To assess the value of effective regurgitant orifice (ERO) in predicting outcome after edge-to-edge transcatheter mitral valve repair (TMVR) for secondary mitral regurgitation (SMR) and identify the optimal cut-off for patients' selection.

Methods: Using the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry, that included patients undergoing edge-to-edge TMVR for SMR between November 2008 and January 2019 in 8 experienced European centres, we assessed the optimal ERO threshold associated with mortality in SMR patients undergoing TMVR, and compared characteristics and outcomes of patients according to baseline ERO.

Results: Among 1062 patients with severe SMR and ERO quantification by proximal isovelocity surface area method in the registry, ERO was < 0.3 cm in 575 patients (54.1%), who were more symptomatic at baseline (NYHA class ≥ III: 91.4% vs. 86.9%, for ERO < vs. ≥ 0.3 cm; P = 0.004). There was no difference in all-cause mortality at 2-year follow-up according to baseline ERO (28.3% vs. 30.0% for ERO < vs. ≥ 0.3 cm, P = 0.585). Both patient groups demonstrated significant improvement of at least one NYHA class (61.7% and 73.8%, P = 0.002), resulting in a prevalence of NYHA class ≤ II at 1-year follow-up of 60.0% and 67.4% for ERO < vs. ≥ 0.3 cm, respectively (P = 0.05).

Conclusion: All-cause mortality at 2 years after TMVR does not differ if baseline ERO is < or ≥ 0.3 cm, and both groups exhibit relevant clinical improvements. Accordingly, TMVR should not be withheld from patients with ERO < 0.3 cm who remain symptomatic despite optimal medical treatment, if TMVR appropriateness was determined by experienced teams in dedicated valve centres.
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http://dx.doi.org/10.1007/s00392-021-01807-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099828PMC
May 2021

Fate of Tricuspid Regurgitation in Patients Undergoing Transcatheter Edge-to-Edge Mitral Valve Repair.

EuroIntervention 2021 03 2. Epub 2021 Mar 2.

Department of Internal Medicine II, University Hospital Bonn, Bonn, Germany.

Background: Mitral valve repair may lead to alterations of tricuspid regurgitation (TR).

Aims: We investigated alterations, predictors and prognostic relevance of TR evolution in a large-scale multicentre population of patients undergoing transcatheter mitral valve repair (TMVR) via MitraClip.

Methods: In total, we included 531 TMVR-patients with at least one available follow-up echocardiography. TR-improvement was defined as a TR ≥II at baseline, which showed a decline of at least one TR-categorization.

Results: Distribution of pre-procedural TR severity was TR0/I 41% (220/531), TRII 39% (209/531) and TR≥III 19% (102/531), respectively. Follow-up echocardiography was at 308±187days. TR severity improved to TR0/I 49% (259/531), TRII 35% (183/531) and TRIII 17% (89/531), p=0.003. Out of 311 patients with TR≥II at baseline, 41% (127/311) showed TR-improvement. Atrial fibrillation (AF), residual mitral regurgitation ≥II (rMR) and tricuspid annular diameter (TAD) remained variables which prevented TR-improvement [odds ratio 0.49(0.29-0.84), 0.47(0.27-0.81) & 0.97(0.93-0.997), respectively]. TR-improvement was associated with better event-free survival regarding post-procedural heart-failure hospitalization (HHF) [hazard ratio 0.6(0.38-0.94)]. The main changes of TR-severity occurred within 3-month post TMVR (p=0.006), while there were only minor TR-changes between 3 and 12-month of follow-up (p=0.813).

Conclusions: TR-improvement was frequent after TMVR. Predictors preventing TR-improvement were AF, post-procedural rMR, and TAD. Furthermore, TR-improvement was an early phenomenon primarily occurring within the first three months post TMVR and served as a suitable marker of reduced HHF.
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http://dx.doi.org/10.4244/EIJ-D-20-01094DOI Listing
March 2021

Extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest: first results and outcomes of a newly established ECPR program in a large population area.

Perfusion 2021 Feb 24:267659121995995. Epub 2021 Feb 24.

Department of Cardiothoracic Surgery, University Hospital Cologne, Heart Centre, Cologne, Germany.

Objectives: Out-of-hospital cardiac arrest (OHCA) is associated with excessively high mortality rates. Recent studies suggest benefits from extracorporeal cardiopulmonary resuscitation (ECPR) performed in selected patients. We sought to present the first results from our interdisciplinary ECPR program with a particular focus on early outcomes and potential risk factors associated with in-hospital mortality.

Methods: Between January 2016 and December 2019, 44 patients who underwent ECPR selected according to our institutional ECPR protocol were retrospectively analyzed regarding pre-hospital, in-hospital, and early outcome parameters. Patients were divided into survivors (S) and non-survivors (NS). Statistical analysis of risk factors regarding in-hospital mortality of the patient cohort analyzed was performed.

Results: The mean age of the population was 53 ± 12 years, with most patients being male ( = 40). The leading cause of cardiac arrest (CA) was myocardial infarction ( = 24, 55%). The median hospital stay was 1 (1;13) day. Twenty-three percent of patients ( = 10) were discharged from hospital including eight patients (18%) with CPC 1-2. Survivors showed a trend toward shorter pre-hospital CPR duration (60 (59;60) min (S) vs 60 (55;90) min (NS), p = 0.07).

Conclusion: Establishing ECPR programs in large population areas offers the option to improve survival rates for OHCA patients. Stringent compliance of institutional criteria (mainly age, witnessed arrest, and time of pre-hospital resuscitation) and providing ECPR to strictly selected patients seems to be a vital factor for such programs' success. Pre-clinical settings and therapeutic measures must be adjusted in this regard to improve outcomes for this highly demanding patient cohort.
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http://dx.doi.org/10.1177/0267659121995995DOI Listing
February 2021

Impact of Right Ventricular Dysfunction on Outcomes After Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation.

JACC Cardiovasc Imaging 2021 Apr 10;14(4):768-778. Epub 2021 Feb 10.

Department of Cardiology, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; Munich Heart Alliance, Partner Site, German Center for Cardiovascular Disease, Munich, Germany. Electronic address:

Objectives: This study sought to assess the impact of right ventricular dysfunction (RVD) as defined by impaired right ventricular-to-pulmonary artery (RV-PA) coupling, on survival after edge-to-edge transcatheter mitral valve repair (TMVR) for severe secondary mitral regurgitation (SMR).

Background: Conflicting data exist regarding the benefit of TMVR in severe SMR. A possible explanation could be differences in RVD.

Methods: Using data from the EuroSMR (European Registry on Outcomes in Secondary Mitral Regurgitation) registry, this study compared the characteristics and outcomes of SMR patients undergoing TMVR, according to their RV-PA coupling, assessed by tricuspid annular plane systolic excursion-to-systolic pulmonary artery pressure (TAPSE/sPAP) ratio.

Results: Overall, 817 patients with severe SMR and available RV-PA coupling assessment underwent TMVR in the participating centers. RVD was present in 211 patients (25.8% with a TAPSE/sPAP ratio <0.274 mm/mm Hg). Although all patients demonstrated significant improvement in their New York Heart Association (NYHA) functional class, there was a trend toward a lower rate of NYHA functional class I or II among patients with RVD (56.5% vs. 65.5%, respectively; p = 0.086) after TMVR. Survival rates at 1 and 2 years were lower among patients with RVD (70.2% vs. 84.0%, respectively; p < 0.001; and 53.4% vs. 73.1%, respectively; p < 0.001). On multivariate analysis, a reduced TAPSE/sPAP ratio was a strong predictor of mortality (odds ratio: 1.62; 95% confidence interval: 1.14 to 2.31; p = 0.007).

Conclusions: RVD, as shown by impairment of RV-PA coupling, is a major predictor of adverse outcome in patients undergoing TMVR for severe SMR. The often neglected functional and anatomic RV parameters should be systematically assessed when planning TMVR procedures for patients with severe SMR.
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http://dx.doi.org/10.1016/j.jcmg.2020.12.015DOI Listing
April 2021

One-year results of the first-in-man study investigating the Atrial Flow Regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study.

Eur J Heart Fail 2021 05 5;23(5):800-810. Epub 2021 Mar 5.

Department of Internal Medicine, Cardiology, Angiology and Intensive Care Medicine, University Clinic Saarland, Homburg, Germany.

Aims: Attenuating exercise-induced elevated left atrial pressure with an atrial shunt device is under clinical investigation for treatment of symptomatic heart failure (HF).

Methods And Results: PRELIEVE was a prospective, non-randomised, multicentre, first-in-man study in symptomatic HF patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg during exercise. Here, we provide follow-up data up to 1 year after implantation of the Atrial Flow Regulator (AFR) device. The AFR was successfully implanted in 53 patients (HFrEF n = 24 and HFpEF n = 29). Two patients were not enrolled due to an unsuccessful transseptal puncture. There was one device embolisation into the left atrium, which required surgical removal. One patient experienced a serious procedure-related adverse event (post-procedural bleeding and syncope). All patients with sufficient echocardiography readout confirmed device patency with left-right shunt both at 3 (n = 47/51, 92%) and 12 (n = 45/49, 92%) months. At 3 months, rest PCWP decreased by 5 (-12, 0) mmHg (P = 0.0003, median Q1, Q3). No patient developed a stroke, worsening of right heart function or significant increase of pulmonary artery pressure. Six (6/53, 11%) patients were hospitalised for worsening of HF and three (3/53, 6%) patients died. We observed improvements in New York Heart Association functional class, 6-min walking distance and quality of life (Kansas City Cardiomyopathy Questionnaire) in certain patients.

Conclusions: Implantation of the AFR device in HF patients was feasible. No shunt occlusion, stroke or new right HF was observed during the 1-year follow-up, with clinical improvements in certain patients.
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http://dx.doi.org/10.1002/ejhf.2119DOI Listing
May 2021

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

Clin Res Cardiol 2021 Jan 31. Epub 2021 Jan 31.

Department of Cardiology, Angiology, Pneumology and Medical Intensive Care, Heart Center of the University of Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

Background: Reliable risk scores in patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) are lacking. Heart failure is common in these patients, and risk scores derived from heart failure populations might help stratify TMVR patients.

Methods: Consecutive patients from three Heart Centers undergoing TMVR were enrolled to investigate the association of the "Get with the Guidelines Heart Failure Risk Score" (comprising the variables systolic blood pressure, urea nitrogen, blood sodium, age, heart rate, race, history of chronic obstructive lung disease) with all-cause mortality.

Results: Among 815 patients with available data 177 patients died during a median follow-up time of 365 days. Estimated 1-year mortality by quartiles of the score (0-37; 38-42, 43-46 and more than 46 points) was 6%, 10%, 23% and 30%, respectively (p < 0.001), with good concordance between observed and predicted mortality rates (goodness of fit test p = 0.46). Every increase of one score point was associated with a 9% increase in the hazard of mortality (95% CI 1.06-1.11%, p < 0.001). The score was associated with long-term mortality independently of left ventricular ejection fraction, NYHA class and NTproBNP, and was equally predictive in primary and secondary mitral regurgitation.

Conclusion: The "Get with the Guidelines Heart Failure Risk Score" showed a strong association with mortality in patients undergoing TMVR with additive information beyond traditional risk factors. Given the routinely available variables included in this score, application is easy and broadly possible.
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http://dx.doi.org/10.1007/s00392-021-01804-3DOI Listing
January 2021

Case report: Transcatheter valve repair with Cardioband: a new treatment option for secondary tricuspid regurgitation in cardiac transplant patients.

Eur Heart J Case Rep 2020 Dec 13;4(6):1-4. Epub 2020 Dec 13.

Department of Cardiology, Heart Center, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

Background: Tricuspid regurgitation (TR) is the most frequent valvular complication after cardiac transplantation. As in native hearts, the role of surgical therapy particularly in secondary TR is unclear due to high procedural risk and unsatisfying results. Currently, percutaneous techniques are under development for TR repair with less procedural risk and promising preliminary results.

Case Summary: We present a 67-year-old man who underwent heart transplantation (biatrial anastomosis) because of ischaemic heart disease 15 years ago and aortic valve replacement in 2010. Because of progressive severe dyspnoea (New York Heart Association Class III) in 2018 and signs of right heart failure with ascites he underwent transthoracic echocardiography which showed normal graft function, but massive TR of functional aetiology. The heart team decision was an interventional approach using the Cardioband System (Edwards Lifesciences) to treat TR based on the high risk associated with a third cardiac surgery and impaired right ventricular function. The procedure was performed in general anaesthesia with transoesophageal echocardiography and fluoroscopic guidance. Tricuspid regurgitation improved from massive to mild with a mean pressure gradient of 2.9 mmHg.

Discussion: This is the first case report of Cardioband implantation in tricuspid position in a heart transplant patient with the good technical and clinical result, suggesting that this technique might offer a treatment option to highly selected post-transplant patients with secondary severe TR and high surgical risk.
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http://dx.doi.org/10.1093/ehjcr/ytaa451DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7793238PMC
December 2020

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

Clin Res Cardiol 2021 May 17;110(5):658-666. Epub 2020 Dec 17.

Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, Heart Center, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.

Background: Frailty is a common characteristic of patients undergoing transcatheter mitral valve repair (TMVR). It is unclear whether the physical vulnerability of frail patients translates into increased procedural health care utilization.

Methods And Results: Frailty was assessed using the Fried criteria in 229 patients undergoing TMVR using the MitraClip system at our institution and associations with total costs and costs by cost centers within the hospital incurred during periprocedural hospitalization were examined. Frail patients (n = 107, 47%) compared to non-frail patients showed significantly higher total costs [median/interquartile range, excluding implant costs: 7,337 € (5,911-9,814) vs 6,238 € (5,584-7,499), p = 0.001], with a difference in means of 2,317 €. Frailty was the only clinical baseline characteristic with significant association with total costs. Higher total costs in frail patients were attributable primarily to longer stay on intermediate/intensive care unit (3.8 ± 5.7 days in frail vs 2.1 ± 1.7 days in non-frail, p = 0.003), but also to costs of clinical chemistry and physiotherapy. The prolonged stay on intermediate/intensive care unit in frail patients was attributable to postprocedural complications such as bleeding, kidney injury, infections and cardiovascular instability.

Conclusion: Frailty is associated with a mean 32% increase of hospital costs in patients undergoing TMVR, which is primarily the result of a prolonged recovery and increased vulnerability to complications. These findings are valuable for a hospital's total cost calculation and resource allocation planning. Since frailty is regarded a potentially reversible health state, preventive interventions may help reduce costs in frail patients.
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http://dx.doi.org/10.1007/s00392-020-01789-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099800PMC
May 2021

German Multicenter Experience With a New Leaflet-Based Transcatheter Mitral Valve Repair System for Mitral Regurgitation.

JACC Cardiovasc Interv 2020 12;13(23):2769-2778

Department of Cardiology, Heart Centre, Faculty of Medicine, University of Cologne, Cologne, Germany. Electronic address:

Objectives: The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system.

Background: The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture.

Methods: Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE).

Results: Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%).

Conclusions: Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status.
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http://dx.doi.org/10.1016/j.jcin.2020.08.025DOI Listing
December 2020

Impact of cleft-like indentations on procedural outcome of percutaneous edge-to-edge mitral valve repair.

Catheter Cardiovasc Interv 2021 May 1;97(6):1236-1243. Epub 2020 Oct 1.

Clinic III for Internal Medicine, Department of Cardiology, Heart Center, Medical Faculty, University Hospital of Cologne, Cologne, Germany.

Objectives And Background: Percutaneous edge-to-edge mitral valve (MV) repair (PMVR) is broadly applied in high-risk patients with relevant mitral regurgitation (MR). We investigated the incidence of cleft-like indentations (CLI) and their impact on PMVR.

Methods And Results: In a retrospective single center analysis including 263 patients undergoing PMVR with the MitraClip®-system between 11/2012 and 7/2016, MV anatomy was assessed by 3-dimensional transesophageal echocardiography. CLI were present in 37/263 patients (14.1%). Of these, 62.2% had 1 CLI, 27% had 2 CLI, and 10.8% had 3 CLI, mostly concerning segment P2 or P2/3 of the MV. Baseline characteristics were similarly distributed. Interestingly, most patients with CLI suffered from secondary MR (n = 29, 78%). The number of deployed MitraClips was higher in patients with CLI (2 [1.25-2] vs. 2 [1, 2], p = .035), whereas procedural as well as clinical success was similar: MR grade (1.2 vs. 1.5, p = .061), vena contracta width (4.2 vs. 4.5 mm, p = .293), dPmean (4.2 vs. 4.0 mmHg, p = .618) at discharge and NYHA class at 30 days did not differ between groups. Periprocedural complications were rare and equally distributed between groups. At 30 days, MR reduction persisted in patients with CLI (95.8% of these selected patients had a MR grade ≤ 2).

Conclusions: CLI of the MV are common in patients undergoing PMVR, also when presenting mainly with secondary MR. While the number of clips needed to address MR is slightly higher in patients with CLI, procedural success rates appear not to be affected. PMVR seems to be a safe treatment option for patients with CLI.
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http://dx.doi.org/10.1002/ccd.29286DOI Listing
May 2021

Pulmonary angiosarcoma: a rare cause of right ventricular outflow tract obstruction.

J Cardiovasc Med (Hagerstown) 2021 Aug;22(8):664-667

Department of Acute and Emergency Care, St.-Antonius-Hospital gGmbH, Eschweiler, Germany.

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http://dx.doi.org/10.2459/JCM.0000000000001105DOI Listing
August 2021

Impact of Proportionality of Secondary Mitral Regurgitation on Outcome After Transcatheter Mitral Valve Repair.

JACC Cardiovasc Imaging 2021 Apr 26;14(4):715-725. Epub 2020 Aug 26.

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; Munich Heart Alliance, Partner Site German Center for Cardiovascular Disease, Munich, Germany. Electronic address:

Objectives: The purpose of this paper was to evaluate the impact of proportionality of secondary mitral regurgitation (SMR) in a large real-world registry of transcatheter edge-to-edge mitral valve repair (TMVr) BACKGROUND: Differences in the outcomes of recent randomized trials of TMVr for SMR may be explained by the proportionality of SMR severity to left ventricular (LV) volume.

Methods: The ratio of pre-procedural effective regurgitant orifice area (EROA) to LV end-diastolic volume (LVEDV) was retrospectively assessed in patients undergoing TMVr for severe SMR between 2008 and 2019 from the EuroSMR registry. A recently proposed SMR proportionality scheme was adapted to stratify patients according to EROA/LVEDV ratio in 3 groups: MR-dominant (MD), MR-LV-co-dominant (MLCD), and LV-dominant (LD). All-cause mortality was assessed as a primary outcome, secondary heart failure (HF) outcomes included hospitalization for HF (HHF), New York Heart Association (NYHA) functional class, N-terminal pro-B-type natriuretic peptide (NT-proBNP), 6-min-walk distance, quality of life and MR grade.

Results: A total of 1,016 patients with an EROA/LVEDV ratio were followed for 22 months after TMVr. MR was reduced to grade ≤2+ in 92%, 96%, and 94% of patients (for MD, MLCD, and LD, respectively; p = 0.18). After adjustment for covariates including age, sex, diabetes, kidney function, body surface area, LV ejection fraction, and procedural MR reduction (grade ≤2+), adjusted rates of 2-year mortality in MD patients did not differ from those for MLCD patients (17% vs. 18%, respectively), whereas it was higher in LD patients (23%; p = 0.02 for comparison vs. MD+MLCD). The adjusted first HHF rate differed between groups (44% in MD, 56% in MLCD, 29% in LD; p = 0.01) as did the adjusted time for first death or HHF rate (66% in MD, 82% in MLCD, 68% in LD; p = 0.02). Improvement of NYHA functional class was seen in all groups (p < 0.001). Values for 6-min-walk distances, quality of life and NT-proBNP improved in most patients.

Conclusions: MD and MLCD patients had a comparable, adjusted 2-year mortality rate after TMVr which was slightly better than that of LD patients. Patients treated with TMVr had symptomatic improvement regardless of EROA/LVEDV ratio.
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http://dx.doi.org/10.1016/j.jcmg.2020.05.042DOI Listing
April 2021

Contrast-Enhanced Ultrasound for the Detection of Abdominal Complications in Infective Endocarditis: First Experience From a Prospective Cohort.

Ultrasound Med Biol 2020 11 26;46(11):2965-2971. Epub 2020 Aug 26.

University of Cologne, Department I of Internal Medicine, Division of Infectious Diseases, Cologne, Germany.

Embolic events are associated with increased mortality in patients with infective endocarditis (IE). The goal of this study was to gain experience with the application of contrast-enhanced ultrasound (CEUS) in IE to detect abdominal complications. CEUS was performed in 40 patients from a prospective register of IE. CEUS was able to detect abdominal embolic events or metastatic infection in 12 patients (30%). Most commonly seen were splenic infarctions (n = 10), followed by renal infarction (n = 2), liver abscess (n = 1) and mycotic aneurysm (n = 1). Six out of 14 lesions were only detected by CEUS and not by conventional ultrasound. Abdominal complications revealed by CEUS were associated with a detectable valve vegetation (p = 0.04) and larger vegetation size (p = 0.01). In three patients, a non-IE related abdominal lesion (two hepatocellular carcinomas, one psoas hematoma) was detected. CEUS is a feasible diagnostic method in detection of abdominal complications of IE.
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http://dx.doi.org/10.1016/j.ultrasmedbio.2020.07.027DOI Listing
November 2020

Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system.

EuroIntervention 2021 May;17(1):81-87

Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.

Background: The Cardioband tricuspid valve reconstruction system is a size-adjustable tricuspid reconstruction device for interventional treatment of tricuspid regurgitation (TR). Contraction of the device after successful implantation can be associated with an acute deformation of the right coronary artery (RCA).

Aims: The aim of this study was to provide data on the persistence and clinical significance of acute RCA deformation following Cardioband implant procedures.

Methods: Data from all patients with intraprocedural RCA deformation during Cardioband implantation were collected from four centres between October 2018 and January 2020. Control angiographies were performed in all of these patients before discharge.

Results: RCA deformation occurred in 14 out of 51 patients. Follow-up coronary angiography showed a complete resolution of deformation in all cases while patients remained clinically asymptomatic and had an uneventful post-interventional course. Intraprocedural coronary stent implantation was performed in two of the earlier cases according to the personal assessment of the implanters.

Conclusions: RCA deformation is relatively frequent following interventional tricuspid annuloplasty but appears to be completely reversible in the absence of flow impairment or vascular damage. Based on our early experience watchful waiting is the most appropriate strategy to avoid unnecessary coronary interventions.
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http://dx.doi.org/10.4244/EIJ-D-20-00305DOI Listing
May 2021

Association of iron deficiency, anaemia, and functional outcomes in patients undergoing edge-to-edge mitral valve repair.

ESC Heart Fail 2020 10 3;7(5):2379-2387. Epub 2020 Jul 3.

Faculty of Medicine and University Hospital Cologne, Department III of Internal Medicine, Heart Center, University of Cologne, Cologne, Germany.

Aims: Patients undergoing percutaneous mitral valve repair (PMVR) show a substantial heterogeneity of prognostic and symptomatic benefit. Iron deficiency and anaemia are associated with worse outcomes in heart failure patients. We investigated the impact of these comorbidities on functional and clinical outcome after PMVR.

Methods And Results: Iron deficiency and anaemia were prospectively assessed in 130 patients undergoing PMVR with MitraClip. Associations with functional outcomes at 6 weeks [6 min walking distance (6MWD), Short-Form-36 physical component score, and Minnesota Living with Heart Failure Questionnaire score, New York Heart Association class] and long-term clinical outcome were examined. Iron deficiency and anaemia were frequent with 52% and 50%, respectively. Patients with anaemia showed significant worse baseline functional measures, whereas patients with iron deficiency showed only a trend for lower baseline 6MWD. The benefit in functional outcomes after PMVR was notable and did not differ significantly by iron deficiency or anaemia status (range of median changes in 6MWD 35 to 45 m, physical component score 5.6 to 7.2, Minnesota Living with Heart Failure Questionnaire -8.0 to -10.5; improvement of ≥1 New York Heart Association class 69% to 80%). Anaemia was associated with higher risk for the combined endpoint of mortality and heart failure hospitalization (hazard ratio: 2.51; 95% confidence interval: 1.24-5.1; P = 0.01), whereas iron deficiency showed a trend towards more heart failure hospitalizations (hazard ratio: 2.94; 95% confidence interval: 0.94-9.03; P = 0.09).

Conclusions: The prevalence of iron deficiency and anaemia is high in patients undergoing MitraClip. Clinical baseline status and long-term outcome were worse particularly in patients with anaemia. However, the functional benefit of PMVR was equal in patients with and without iron deficiency and anaemia.
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http://dx.doi.org/10.1002/ehf2.12778DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7524056PMC
October 2020

Coexistence and outcome of coronary artery disease in Takotsubo syndrome.

Eur Heart J 2020 09;41(34):3255-3268

Department of Cardiology, Kantonsspital Lucerne, Lucerne, Switzerland.

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

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

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

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

Impact of COAPT trial exclusion criteria in real-world patients undergoing transcatheter mitral valve repair.

Int J Cardiol 2020 10 26;316:189-194. Epub 2020 May 26.

University of Cologne, Faculty of Medicine and University Hospital Cologne, Department III of Internal Medicine, Heart Center, Germany.

Background: The generalizability of the COAPT trial results on the benefit of TMVR in patients with secondary mitral regurgitation is unclear.

Methods: Functional and long-term clinical outcome were examined in 122 consecutive patients with secondary mitral regurgitation and reduced ejection fraction undergoing TMVR. "COAPT-like" patients were defined according to principal COAPT inclusion/exclusion criteria if all of the following was fulfilled: symptomatic mitral regurgitation grade 3+ or more according to American guidelines; left ventricular ejection fraction ≥ 20%, left ventricular end-systolic dimension ≤ 70 mm, estimated pulmonary artery systolic pressure ≤ 70 mmHg, mitral valve orifice area ≥ 4 cm, no prior mitral valve procedure, no right sided congestive heart failure, no COPD requiring home oxygen therapy and NYHA class less than IVb.

Results: 51% of 122 patients (mean age 74 ± 10 years, 76% male) showed COAPT-like characteristics. COAPT-like patients showed a significantly lower hazard for the composite endpoint of mortality and heart failure hospitalization (HR 0.51, 95%CI 0.30-0.89, p = .017) during a mean follow-up of 16 ± 6 months, with an estimated 1-year event rate of 20% vs 43%, respectively. The improvement in functional outcomes 6 min walking distance (76 ± 136 m vs. 31 ± 90 m), Minnesota Living with Heart Failure Questionnaire (-6 ± 19 vs. -10 ± 23) and Short Form 36 physical component score (3.8 ± 10 vs. 5.5 ± 11) was similar in COAPT-like and the other patients.

Conclusion: In this first real world cohort half of the patients undergoing TMVR showed COAPT-like characteristics and these patients showed a substantially better clinical outcome. The mid-term functional benefit was similar in COAPT-like and other patients.
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http://dx.doi.org/10.1016/j.ijcard.2020.05.061DOI Listing
October 2020
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