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Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited.We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI.We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria.Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08).A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

Percutaneous coronary intervention (PCI) is indispensable in cardiology; however, exposure to potentially harmful ionising radiation remains a concern.This study was designed to assess the PCI-related radiation dose over the last decade and to identify predictors of increased dose exposure.The PROcedural radiaTion dose Exposure in percutaneous Coronary intervenTION (PROTECTION VIII) study included all PCIs reported to a German quality assurance programme between 2008 and 2018. Dose area product (DAP) and radiation time were analysed. Effective dose (ED) was estimated (ED=DAP*k; conversion coefficient k=0.0022 mSv/cGy*cmWe enrolled 3,704,986 patients undergoing PCI (median age 70 years, 30% female). Indications were chronic coronary syndrome (37.5%), unstable angina pectoris and non-ST-segment elevation myocardial infarction (non-STEMI; 33.2%) and STEMI (18.5%). Median DAP was 4,203 (interquartile range [IQR] 2,313-7,300) cGy*cm, ED was 9.2 mSv and median radiation time was 9.2 (IQR 5.8-15.0) min. Within the 10-year period, radiation exposure was reduced by 36% (p0.001) and resulted in a median DAP of 3,070 cGy*cm (ED 6.8 mSv) in 2018. A significant 5.3-fold variability of median DAP was observed between catheterisation laboratories (p0.001). We identified patient-related (gender, coronary artery bypass graft surgery, heart failure) and procedure-related (coronary occlusion PCI, ostial lesion PCI, left main PCI, multivessel PCI) predictors of increased radiation dose (all p0.001).This radiation dose survey demonstrates a considerable reduction of PCI radiation exposure during the last decade. However, large variability between catheterisation laboratories underlines the need for further radiation dose reduction.

Aims Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularisation but has plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downward spiral towards death, which becomes difficult to reverse. We aimed to test in a robust, prospective, randomised controlled trial whether early support with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides clinical benefit by improving mortality and morbidity. Methods and results The EURO SHOCK trial will test the benefit or otherwise of mechanical cardiac support using VA-ECMO, initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomise 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or standard pharmacotherapy alone. It will be conducted in 39 European centres. The primary endpoint is 30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure. Cost-effectiveness analysis (including quality of life measures) will be embedded. Mechanistic and hypothesis-generating substudies will be undertaken. Conclusions The EURO SHOCK trial will determine whether early initiation of VA-ECMO in patients presenting with ACS-CGS persisting after PCI improves mortality and morbidity.

Aims The aim of this study was to compare the outcome of patients with a post-procedural tricuspid valve gradient (TVG) of >3 mmHg vs ≤3 mmHg after transcatheter edge-to-edge tricuspid valve repair (TTVR). Methods and results Between March 2016 and October 2018 we treated 145 patients with severe tricuspid regurgitation (TR) with TTVR by placing 2.2±0.7 clips per patient. Device success (TR reduction ≥1° to at least moderate) was achieved in 125 patients (86.2%). TTVR resulted in an elevated TVG >3 mmHg in 25 (17.2%) patients. Device success (84% vs 86.7%, p=0.9), number of clips implanted (2.3±0.7 vs 2.2±0.7, p=0.33), clinical improvement including NYHA class (III/IV 24% vs 28%, p=0.92) and increase in six-minute walking test at one month (67 m [IQR 5-103 m] vs 56 m [IQR 8-97 m], p=0.93), mortality (HR 1.07, 95% CI: 0.43-2.65, plogrank=0.88) and the combined endpoint mortality and hospitalisation for heart failure at one year (HR 1.07, 95% CI: 0.46-2.48, plogrank=0.88) were similar between patients with a TVG >3 mmHg versus patients with a TVG ≤3 mmHg. Conclusions A small cohort of patients demonstrated an elevated TVG higher than 3 mmHg at discharge. This elevation had no impact on clinical improvement, mortality or hospitalisation for heart failure.

AIMS: Clopidogrel is the P2Y12 inhibitor of choice in patients who undergo PCI and have an indication for oral anticoagulation (OAC). Prediction of the bleeding risk is of major interest in this population. The aim of this analysis was to investigate whether an enhanced platelet inhibition by clopidogrel measured by platelet function testing (PFT) with the Multiplate analyzer is associated with an increased bleeding risk in patients on triple antithrombotic therapy.METHODS AND RESULTS: This investigation was performed in a cohort of 524 patients from the randomized ISAR TRIPLE trial and 458 (87.4%) had PFT results available in the first 24 hours after PCI. Patients belonging to the lowest quintile according to PFT were considered as enhanced responders to clopidogrel. The primary endpoint was major bleeding according to TIMI criteria at 9 months. The median of ADP-induced platelet aggregation in the whole population was 163 AU*min [107-241]. Patients in the lowest quintile had values below 93 AU*min. These enhanced responders (92 patients) had a significantly higher risk of TIMI Major Bleeding (hazard ratio [HR]: 3.13, [95% confidence interval: 1.38-7.09], p=0.01) and overall mortality (HR: 3.42, [1.55-7.52], p=0.004) compared with the remaining patients (366 patients). No significant difference was observed for the secondary combined ischemic endpoint (HR: 1.27, [0.47-3.47], p=0.64).CONCLUSIONS: Enhanced platelet inhibition delivered by clopidogrel is associated with an increased risk for major bleeding and death in patients on OAC that undergo PCI. These results support the use of PFT to identify patients with an increased risk for bleeding.

Aims Women and men suffering from coronary artery disease differ in their risk profiles. We sought to investigate the impact of sex on two-year outcomes after BVS implantation in routine clinical practice. Methods and results Sex-based analysis of clinical outcomes was carried out by pooling the individual patient data of the ISAR-ABSORB and KUM-ABSORB registries performed in four high-volume tertiary centres in Munich. Of the total of 1,032 patients, 259 (25.1%) were women. The primary composite endpoint of death, target vessel myocardial infarction (TV-MI) and target lesion revascularisation (TLR) up to two years occurred in 13.2% of women and 17.9% of men (p=0.12). Compared to men, women experienced numerically lower rates of TLR and definite or probable BVS thrombosis - 7.5% vs 12.4% (p=0.051) and 1.2% and 2.7% (p=0.20), respectively. Independent predictors of increased risk for TLR were use of smaller size BVS (HR 1.28, 95% CI: 1.02-1.62), while being a woman was a protective factor (HR 0.59, 95% CI: 0.35-1.00). Conclusions BVS used in a routine setting tend to perform better among women compared to men, which might be partially related to the lower complexity of their coronary artery disease.

Aims: The aim of this study was to investigate the procedural feasibility and short-term durability of the transcatheter tricuspid valve edge-to-edge repair technique in highly symptomatic patients with severe tricuspid regurgitation (TR). Methods and results: Eighteen consecutive patients suffering from severe right-sided heart failure (NYHA Class III-IV), primarily due to moderate to severe tricuspid regurgitation, were included in the study. Applying a modified steering technique for the clip delivery system, six patients were treated for isolated severe TR, while 12 patients were treated for moderate to severe TR and concomitant severe mitral regurgitation. The primary objectives were procedural success, defined as reduction of at least one TR grade, and 30-day echocardiographic and clinical outcomes. A total of 41 clips (2.3 +/- 0.7 per patient) were placed into the tricuspid valve of high surgical risk patients (EuroSCORE II: 10 +/- 8%). Procedural success was achieved in all patients;no MACCE occurred in hospital. The presence of a TR grade >= 3 was reduced from 94% (17 patients) before the procedure to 33% (six patients) at 30-day follow-up (p< 0.001). Sixteen patients (89%) reported an improvement in NYHA functional class at 30 days. Conclusions: Applying a modified steering technique, the edge-to-edge repair technique can be successfully used for the treatment of TR. At 30-day follow-up, the short-term durability of TR reduction appeared promising and the majority of patients improved clinically. Further studies with larger patient populations and longer follow-up have to define the role of this novel treatment option for patients with right-sided heart failure and severe TR.

Aims: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. Methods and results: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p

Aims To evaluate the characteristics and clinical outcome of patients with new formation of left ventricular (LV) thrombus after percutaneous edge-to-edge mitral valve repair. Methods and results Between 2009 and 2012 we intended to treat 150 patients with severe mitral regurgitation (MR) with percutaneous edge-to-edge mitral valve repair in our centre. Post-procedural transthoracic echocardiographic examinations scheduled during the hospital stay revealed the new formation of LV thrombi in three out of 150 patients. All three patients suffered from end-stage systolic heart failure with a LV ejection fraction (LVEF) below 20% and were successfully treated in terms of MR reduction (reduction of at least two MR grades). No thrombus formation was observed in patients with a LVEF >20% treated in our centre (a total of 136 patients). The frequency of new LV thrombus formation in the cohort of patients with a LVEF ≤20% treated in our centre was 21% (three out of 14 patients). Conclusions New formation of LV thrombus was detected in patients with severely depressed LVEF (≤20%) after successful reduction of MR following percutaneous edge-to-edge mitral valve repair. This phenomenon could be a play of chance, but percutaneous edge-to-edge mitral valve repair using the MitraClip¨ system is a new procedure. Special care is needed when performing new procedures, and the unexpected post-procedural finding of LV thrombus formation in approximately 20% in this cohort is worth reporting.

AIMS Thirty-day results of the double-blind, randomised Intracoronary Stenting and Antithrombotic Regimen -Rapid Early Action for Coronary Treatment (ISAR-REACT) 4 trial showed no difference in ischaemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). A longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy. METHODS AND RESULTS The primary outcome for this analysis was the composite of death, myocardial infarction or target vessel revascularisation one year after randomisation. Secondary outcome was the composite of death or myocardial infarction. At one year, the primary outcome occurred in 21.3% of patients assigned to abciximab and heparin versus 21.5% assigned to bivalirudin (hazard ratio [HR] 0.99; 95% confidence interval [CI]: 0.80-1.21; p=0.94). The combined incidence of death or myocardial infarction was 15.7% in the abciximab and heparin group versus 16.0% in the bivalirudin group (HR 0.99; 95% CI: 0.78-1.26; p=0.94). The mortality rates were 4.0% and 4.7%, respectively (HR 0.85; 95% CI: 0.54-1.34; p=0.48). At one year, no significant differences in the primary outcome were observed with abciximab and heparin versus bivalirudin in any of the subgroups analysed. CONCLUSIONS In patients with NSTEMI undergoing PCI, abciximab with heparin and bivalirudin provide comparable outcomes at one year, although bivalirudin reduced the rate of bleeding at 30 days. CLINICAL TRIAL REGISTRATION INFORMATION URL www.clinicaltrials.gov; Unique identifier NCT00373451.

Single leaflet clip attachment (SLA) is a prevalent complication in percutaneous edge-to-edge repair of the mitral valve, leading to the recurrence of significant mitral regurgitation. The objective of this retrospective analysis was to evaluate a novel 3-D transoesophageal echocardiographic method for the assessment of clip attachment to the mitral leaflets.We analysed a total of 87 patients treated for symptomatic mitral regurgitation. In 47 patients, clip attachment to the leaflets was assessed by conventional 2-D transoesophageal echocardiography supported by biplane TEE images (biplane TEE group). In 40 patients, clip attachment to the leaflets was assessed by the intraprocedural 3-D volume method in addition to the conventional method (volumetric TEE group). The primary endpoint was defined as clip complications consisting of SLA and clip displacement at any time after clip implantation. Clip complications occurred in nine patients (19.1%) in the biplane TEE group and in two patients (5%) in the volumetric TEE group (p=0.06). Regarding the grade of mitral regurgitation, in the follow-up period we observed a more pronounced deterioration in the biplane TEE group than in the volumetric TEE group.These findings suggest that the additional use of 3-D volumetric transoesophageal echocardiography for the assessment of clip attachment to the mitral leaflets may contribute to a reduced rate of subsequent clip complications.