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Objective Since the beginning of the transcatheter aortic valve implantation (TAVI) era, many prosthetic valves have entered clinical practice. TAVI prostheses differ regarding stent design and some may potentially interfere with diagnostic or interventional catheters. The aim of our analysis was to evaluate the feasibility of coronary angiography (CA) or percutaneous coronary intervention (PCI) in patients with prior TAVI. Methods From 2011 to 2014, 1,000 patients were treated by TAVI at our center using eight different valve prostheses (Symetis ACURATE TA and ACURATE TF; Medtronic CoreValve and Engager; JenaValve, SJM Portico; Edwards Lifesciences SAPIEN and SAPIEN XT). In this analysis, all patients were included who underwent either CA or PCI after TAVI. CA or PCI were rated as fully feasible when coronary ostia could be fully intubated, partially feasible when coronary arteries could be displayed only unselectively or unfeasible when coronary arteries could not be displayed. Results A total of 35 patients underwent CA/PCI after TAVI at our hospital. In all patients with valves implanted in a subcoronary position (SAPIEN n  = 19; JenaValve n  = 1), selective intubation was feasible using standard catheters. Out of 15 patients with valve types that are placed over the coronary ostia (CoreValve n  = 10, ACURATE n  = 4, Portico n  = 1), selective intubation of coronary arteries was not possible in 9 cases, even with the use of different diagnostic catheters. Full accessibility was possible only in 3 cases. In 2 cases, display of the right CA was only feasible using unselective aortography. In 1 case, coronary arteries could not be displayed at all immediately after a valve-in-valve procedure. Conclusion CA or PCI after TAVI is usually feasible. Devices that are placed in a partially supracoronary position, however, can interfere with diagnostic or guiding catheters and impede straightforward intervention, especially when the prosthesis is not implanted in the correct position.

AimsApproximately every fifth patient undergoing transcatheter aortic valve implantation (TAVI) requires a permanent pacemaker (PPM) after the procedure. The aim of this study was to analyse predictors of atrioventricular block III° (AVBIII) persistence with concurrent PPM dependency after TAVI.Methods and resultsBetween 2010 and 2015 a total of 1198 patients underwent TAVI at the Kerckhoff Heart and Thorax Center, Germany. After exclusion of patients with prior PPM (n = 173) 14.7% (n = 176) of the patients underwent PPM implantation after the procedure. Independent predictors of PPM implantation were pre-existing right bundle branch block (RBBB, p < 0.001) and implantation of a CoreValve prosthesis (p < 0.001). A subgroup of patients with a newly implanted PPM (n = 102) were followed-up for a median of 73 (IQR 62–85) days. The leading indication for PPM implantation was AVBIII in 74.5% (76/102). Of these patients only 22.4% (17/76) had persistent AVBIII at follow-up. Predictors of AVBIII persistence were prior RBBB (p = 0.04), postdilatation (p = 0.006) and higher mean aortic valve gradient prior to implantation (p = 0.013). PPMs were implanted earlier in patients with persisting AVBIII [1 day (IQR0–2.5) vs. 4 days (IQR2–7); p < 0.001]. Early PPM implantation after TAVI was the only independent predictor of persistent AVBIII [OR 1.36 (95% 1.05–1.75); p = 0.02].ConclusionThe long-term persistence of AVBIII is generally low after TAVI. Therefore, it may be wise to postpone the indication for PPM implantation for a couple of days. The only predictors of a lack of recovery of the AVB are prior RBBB, higher mean aortic valve gradients and postdilatation of the prosthesis.

Aims We analysed the number of procedures, indications, and in-hospital mortality rates of all patients undergoing isolated surgical aortic valve replacement (sAVR) or transvascular (TV-) and transapical (TA-) transcatheter aortic valve implantation (TAVI) from 2012 to 2015 in Germany. Methods and results More than 31,000 aortic valve procedures were performed in 2015 in Germany, representing a total increase of 4.5% over 2014. TV-TAVI accounts for 13,108 of these procedures, with an increase of 21%, whereas the numbers of isolated sAVR and TA-TAVI decreased slightly. Age, frailty, high risk, and patients’ choice were the main reasons for a catheter-based intervention. In 2015, the in-hospital mortality rate after TV-TAVI decreased to 3.4%, approaching that of sAVR (2.9%), despite a considerably higher baseline risk. A stratified analysis according to the German aortic valve (AKL) score demonstrated a further decrease of the in-hospital mortality for TV-TAVI, showing a lower in-hospital mortality rate than expected in all risk groups. Importantly, this also accounts for the lowest risk group with an AKL score <3% showing an in-hospital mortality rate of 1.7%, which is now comparable to that of sAVR (1.5%). In all other risk groups, the in-hospital mortality in patients undergoing TV-TAVI was lower than in patients undergoing sAVR. Conclusions Mortality after TV-TAVI keeps decreasing over the last years and equals that of SAVR in the lowest risk cohort in the meanwhile. All TV-TAVI patients have significantly lower observed than expected mortality, which will further lead to a redefinition of standard of care.

AimsBoth surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are established options to treat aortic valve stenosis. We present the outcome of the complete cohort of all patients undergoing SAVR or TAVI in Germany during the calendar year 2019.Methods and resultsData concerning all isolated aortic valve procedures performed in Germany in 2019 were retrieved from the mandatory nationwide quality control program: 22,973 transvascular (TV)-TAVI procedures, 7905 isolated SAVR (iSAVR), and 1413 transapical (TA)-TAVI. Data was complete in 99.9% (n = 32,156). In-hospital mortality after TV-TAVI (2.3%) was significantly lower when compared with iSAVR (2.8%, p = 0.007) or TA-TAVI (6.3%; p < 0.001). Expected mortality was calculated with a new version of the German Aortic valve score (AKL Score) based on the data of either catheter-based (AKL-CATH) or surgical (AKL-CHIR) aortic valve replacements in Germany in 2018. TV-TAVI and iSAVR both showed lower observed mortality in 2019 than expected based on their respective performance in 2018, yielding an observed/expected (O/E) mortality ratio < 1. This was particularly apparent for patients at low risk. After exclusion of emergency procedures, in-hospital mortality after TV-TAVI (2.1%) and after iSAVR (2.1%) was identical, even though patients undergoing TV-TAVI showed a considerably higher perioperative risk profile.ConclusionAfter excluding emergency procedures, in-hospital mortality of TV-TAVI and iSAVR in 2019 in Germany was identical. In 2019, TV-TAVI and iSAVR both show lower matched mortality ratios compared with 2018, which suggests technical improvements of both therapies.

AimsTo examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results.Methods and resultsA total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7 mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications.ConclusionPASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.Graphic abstract

BackgroundTranscatheter aortic valve implantation (TAVI) is emerging as the standard of care for patients with severe aortic stenosis. Recent results have been favourable even for patients with low periprocedural risk.MethodsWe analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing isolated aortic valve replacement in 2017 in Germany, focussing especially on transvascular (TV) TAVI. Patients were stratified according the German Aortic Valve Score (AKL) into the risk classes low, intermediate, high and very high (≥ 10%).ResultsA total of 17,956 TV-TAVI and 9011 isolated surgical aortic valve replacements (iSAVR) were performed in Germany in 2017. Although the total rate of intraprocedural complications after TV-TAVI was the same as in 2016 (both 7.4%), fewer patients experienced an arterial vascular complication in 2017 (2017: 6.0%; 2016: 7.1%; p < 0.001). Likewise, the rate of new pacemaker implantation decreased (2017: 9.6%; 2016:11.4%; p < 0.001). In-hospital mortality after TV-TAVI and iSAVR was equal (2.7%) in 2017, despite the much higher risk profile of TV-TAVI patients. Using the AKL score as reference, TV-TAVI showed a more favourable observed-to-expected mortality (O/E) ratio (0.89) than iSAVR (1.14)- even more pronounced in patients at low risk (0.81 vs. 1.14).ConclusionsThe rates of major complications like bleeding and permanent pacemaker implantation after TV-TAVI keep declining. In 2017 patients undergoing TV-TAVI had a low in-hospital mortality rate with an O/E ratio < 1, indicating that the results were again better than those of all TAVI and SAVR of the previous year.Graphic abstractOverall in-hospital mortality after transvascular TAVI and isolated aortic valve repair 2017 in Germany stratified to risk groups by the German Aortic Valve Score (German AV Score/AKL Score): low risk group (AKL 0– < 3%), intermediate risk group (AKL 3– < 6%), high risk group (AKL 6– < 10%) and very high risk group (AKL ≥ 10%)

BackgroundWithin the last years TAVI—especially transfemoral/transvascular TAVI—has proven to be a valuable therapeutic option for most patients suffering from AS. Here, we present the outcome of a complete dataset of all patients undergoing aortic valve replacement in Germany in 2018.MethodsThe data of all aortic valve procedures performed in Germany in 2018 derive from the mandatory nationwide quality control program. Patients were stratified with a new version of the German Aortic valve score (AKL Score) divided in different risk stratification depending on the treatment with either a catheter based (TV-TAVI) or surgical (iSAVR) approach. In-hospital outcomes have been compared between the two approaches.Results19,317 transvascular (TV)–TAVI procedures were carried out. In contrast to this steady growth, the number of iSAVR andtransapical (TA) -TAVI procedures declined. In-hospital mortality after TV-TAVI (2.5%) was lower when compared to iSAVR (3.1%) as well as TA-TAVI (5.7%) in-hospital mortality after TV-TAVI was significantly lowest (Fig. 2) with an in-hospital mortality rate of 2.5%. TV-TAVI was the only approach with an observed vs. expected mortality ratio < 1 according to the used risk prediction model.ConclusionTV-TAVI is more often performed and shows lower in-hospital mortality than iSAVR. TV-TAVI has replaced iSAVR as the gold-standard concerning in-hospital outcome in aortic stenosis management.

Background A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist‘s toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. Methods The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. Discussion Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. Trial registration number ClinicalTrials.gov Identifier: NCT04470934.

AimsThe 2015 Heart Valve Disease Awareness Survey showed a low knowledge and awareness about heart valve disease in the general population despite its high prevalence and morbidity. The 2017 survey was conducted to re-evaluate concern and knowledge about heart valve disease after 2 years of rapidly increasing patient numbers presenting with heart valve disease.Methods and resultsA total of 12,820 people aged 60 years or older in 11 European countries took part in the survey. While the number of people concerned most about heart valve disease increased significantly (2015:1.7% vs. 2017:2.1%; p < 0.001), it is still very low compared to cancer (28.8%) or Alzheimer’s disease (20.9%). More people claim to be familiar with heart valve disease in general (2015: 17.1% vs. 2017: 20.0%; p < 0.001) and the majority claims to know of at least one therapy for heart valve disease (61.9%). Nevertheless, only 3.8% could correctly identify aortic stenosis (AS), which is significantly less than in 2015 (7.2%; p < 0.001). As before, the majority of the respondents claimed to rarely or never undergo a stethoscope check from their general practitioner (2015: 54.2% vs. 2017: 50.6%, p < 0.001); nevertheless, a positive trend can be seen. People wish heart valve disease to be part of regular checks by the general practitioners.ConclusionThe general population’s knowledge of heart valve disease in general slightly increased over the last 2 years. However, detailed understanding of aortic stenosis and its treatment options is still low, as is the level of concern shown for heart valve disease. Nevertheless, the general population cites heart valve disease as a condition they wish to be checked for regularly.

Die interventionelle Therapie von Bifurkationsläsionen – insbesondere von wahren, komplexen Bifurkationsläsionen – stellt weiterhin für den:die Interventionalisten:in eine Herausforderung dar. Während bei einfachen Bifurkationsläsionen eine primäre 1‑Stent-Strategie zu bevorzugen ist, haben die Studien der letzten Jahre gezeigt, dass bei wahren Bifurkationen, also Läsionen mit mindestens Beteiligung des distalen Hauptastes und des Seitastes, eine 2‑Stent-Strategie von Vorteil sein kann. Noch deutlicher scheint dies der Fall, wenn die Läsion sich als komplex darstellt, d. h. der Seitast hochgradig und längerstreckig stenosiert ist und die gesamte Läsion zudem bestimmte Kriterien aufweist, z. B. eine starke Kalzifizierung und einen Bifurkationswinkel von weniger als 45° oder mehr als 70°. Gemäß den neuesten randomisierten Studien und Metaanalysen scheint besonders die DK(„double kissing“)-Crush- bzw. die DK-Mini-Crush(DKMC)-Technik bei eben diesen Läsionen von Vorteil zu sein. Die etablierten Techniken wurden jedoch in den letzten Jahren immer wieder verfeinert und weiterentwickelt. Besondere Aufmerksamkeit verdienen hier die DK-Culotte-Technik sowie die Nano-crush-Technik. Beide Techniken scheinen die zugrunde liegenden Strategien zu vereinfachen und zu verbessern. Weiterführende Studien, die eine Überlegenheit dieser Techniken gegenüber den etablierten Techniken beweisen, sind jedoch noch ausstehend. Zusammenfassend kann durch die Umsetzung der vorliegenden Ergebnisse aus randomisierten Studien und durch die Weiterentwicklung der Techniken, aber auch des Materials, das Outcome der Patienten nach interventioneller Therapie einer Bifurkationsläsion immer weiter verbessert werden. Dies bestätigen auch die neuesten Registerdaten, die erstmalig gleiche Ereignisraten bei Patienten nach der Therapie von komplexen im Vergleich zu einfachen Läsionen im klinischen Alltag zeigen konnten.