In-hospital Outcomes of Rotational Atherectomy in ST-Elevation Myocardial Infarction: Results From the Multicentre ROTA-STEMI Network.

BACKGROUND: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI). METHODS: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed. RESULTS: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001). CONCLUSIONS: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality.

Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. METHODS: We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. RESULTS: We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. CONCLUSIONS: Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).

Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses.

Debulking techniques are often necessary for successful lesion preparation in percutaneous coronary intervention. The aim of this study was to compare plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). ROTA.shock was a 1:1 randomized, prospective, double-arm, multicenter noninferiority trial designed to compare final minimal stent area after IVL with RA for lesion preparation in percutaneous coronary interventional treatment of severely calcified lesions. On the basis of OCT acquired before and immediately after IVL or RA in 21 of the 70 patients included, we performed a detailed analysis of the modification of the calcified plaque. After RA and IVL, calcified plaque fractures were present in 14 of the patients (67%), with a significantly greater number of fractures after IVL (3.23 ± 0.49) than after RA (1.67 ± 0.52; p < 0.001). Plaque fractures after IVL were longer than after RA (IVL: 1.67 ± 0.43 mm vs RA: 0.57 ± 0.55 mm; p = 0.01), resulting in a greater total volume of the fractures (IVL: 1.47 ± 0.40 mm3 vs RA: 0.48 ± 0.27 mm3; p = 0.003). Use of RA was associated with a greater acute lumen gain than was use of IVL (RA: 0.46 ± 0.16 mm2 vs IVL: 0.17 ± 0.14 mm2; p = 0.03). In conclusion, we were able to show differences in plaque modification of calcified coronary lesions by OCT: although RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial.

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.

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Patients with Porcelain Aorta.

BACKGROUND: Severe calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear. METHODS: Data from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population. RESULTS: Technical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [2.10;11.87]), severe bleeding (OR 1.79 [1.11;2.89]), and major structural cardiac complications (OR 3.37 [1.32;8.57]) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2. CONCLUSION: A porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients.

[Bifurcation lesions : Are new strategies and devices needed?] / Bifurkationsläsionen : Braucht es neue Strategien und Devices?

Interventional treatment of bifurcation lesions, especially true complex bifurcation lesions, continue to be a challenge for interventional cardiologists. A primary one stent strategy is always preferred for simple bifurcation lesions, whereas studies in recent years have shown that a two stent strategy may be advantageous for true bifurcations, i.e. those involving at least the distal main branch as well as the side branch. This seems to be even more pronounced when the lesion presents as complex, i.e., the side branch shows high-grade stenosis over longer stretches and the complete lesion fulfils certain criteria, e.g., severe calcification and a bifurcation angle < 45° or > 70°. According to the latest randomized trials and meta-analyses, the double kissing (DK) crush and double kissing mini-crush (DKMC) techniques in particular seem to be advantageous for these lesions; however, in recent years the established techniques have been continuously refined and further developed. The DK culotte technique and the nano-crush technique deserve special attention. Both techniques seem to further improve and simplify the existing underlying strategies; however, further studies to prove the superiority of these techniques over the established ones are still pending. Overall, the implementation of the available randomized study results, the further development of the techniques and also of the materials can continuously improve the outcome of the patients after interventional treatment of bifurcation lesions. This is also confirmed by the latest registry data, which for the first time could show equal event rates in patients after treatment of complex lesions compared to simple lesions in the clinical practice.

Multi-Center Comparison of Two Self-Expanding Transcatheter Heart Valves: A Propensity Matched Analysis.

BACKGROUND: During the last years, several transcatheter aortic heart valves entered the clinical market and are commercially available. The prostheses differ regarding several technical and functional aspects. However, little is known regarding head-to-head comparative data of the ACURATE neo and the PORTICO valve prostheses. OBJECTIVES: The aim of this study was to compare two self-expanding transcatheter aortic heart valves (THV), the ACURATE neo and the PORTICO, with regard to in-hospital and 30-day outcomes, as well as early device failures. METHODS: A total of 1591 consecutive patients with severe native aortic valve stenosis from two centers were included in the analyses and matched by 1:1 nearest neighbor matching to identify one patient treated with PORTICO (n = 344) for each patient treated with ACURATE neo (n = 344). RESULTS: In-hospital complications were comparable between both valves, including any kind of stroke (ACURATE neo = 3.5% vs. PORTICO = 3.8%; p = 1.0), major vascular complications (ACURATE neo = 4.5% vs. PORTICO = 5.4%; p = 0.99) or life-threatening bleeding (ACURATE neo = 1% vs. PORTICO = 2%; p = 0.68). The rate of device failure defined by the VARC-2 criteria were comparable, including elevated gradients and moderate-to-severe paravalvular leakage (ACURATE neo = 7.3% vs. PORTICO = 7.6%; p = 1.0). However, the need for permanent pacemaker implantation (PPI) was significantly more frequent after the use of PORTICO THV (9.5% vs. 18.7%; p = 0.002). CONCLUSIONS: In this two-center case-matched comparison, short-term clinical and hemodynamic outcomes showed comparable results between PORTICO and ACURATE neo prostheses. However, PORTICO was associated with a significant higher incidence of PPI.

Comparison of adenosine-independent pressure indices to fractional flow reserve in stent-jailed bifurcation side branches.

OBJECTIVES AND BACKGROUND: This study aims to evaluate whether the high correlation and classification agreement of the instantaneous wave-free ratio (iFR) and the resting distal coronary to aortic pressure ratio (Pd /Pa ) with the fractional flow reserve (FFR) can be confirmed in stent-jailed side branches (J-SB). METHODS: Consecutive patients (n = 49) undergoing provisional stenting were prospectively enrolled and a physiological assessment of the J-SB (n = 51) was performed. FFR, iFR, and Pd /Pa were measured and the hemodynamic relevance was determined using cutoff values of ≤0.80, ≤0.89, and ≤0.92, respectively. RESULTS: Both iFR (r = 0.75) and Pd /Pa (r = 0.77) correlated closely with FFR. Classification agreement with FFR was 78% for iFR (81% sensitivity, 77% specificity) and 75% for Pd /Pa (63% sensitivity and 80% specificity). However, angiographic diameter stenosis and pressure indices correlated poorly. For a threshold of ≥70% stenosis, agreement concerning hemodynamic relevance was found in 59% for FFR, 69% for iFR, and 61% for Pd /Pa . CONCLUSION: As reported for other lesion types, FFR and the adenosine-independent pressure indices iFR and Pd /Pa show close correlation and a high classification agreement of approximately 75%-80% in J-SB. Therefore, iFR can be regarded as a recommendable alternative to FFR for the guidance of provisional stenting in bifurcation lesions.

[Myocardial revascularization : Controversy over noninvasive and invasive detection of ischemia]. / Myokardiale Revaskularisation : Kontroverse um den nicht-invasiven und den invasiven Ischämienachweis.

With some exceptions, myocardial revascularization in patients with chronic coronary syndrome (CCS) is generally decided on the basis of the extent of myocardial ischemia. Current data indicate that a patient will benefit from revascularization if ischemia is present in more than 10% of the myocardium. Accordingly, all patients presenting with CCS should undergo a noninvasive ischemia test that can answer this question before diagnostic coronary angiography. In order to be able to make a recommendation for revascularization based on scientific data even in those patients who previously had no clear evidence of ischemia, e.g., because of discrepant findings, measurement of the hemodynamic significance of coronary stenoses with a lumen diameter reduction ≥ 50% should be performed during coronary angiography. A decision to revascularize based on hemodynamic significance was shown to be beneficial to patients in several studies.

Towards a FHIR-Based Data Model for Coronary Angiography Observations.

Coronary heart disease is among the most frequent causes of death globally. Thus, our research project aims to develop prognostic models, to predict the risk of spontaneous myocardial infarctions based on a combination of clinical parameters and image data sets (invasive coronary angiograms). To train such models we use data from more than 30,000 coronary angiograms acquired at the cardiology department of Erlangen University Hospital. To linking such proprietary data with additional clinical parameters and to harmonize it for future cross-hospital federated machine learning approaches we defined a mapping for coronary angiography based on the symptom/ clinical phenotype HL7® FHIR® module of the German medical informatics initiative. In this paper we describe the final design of the coronary angiography information model and our mapping approach to ICD-10 and SNOMED CT. From the database we use a subset of 15 required values patient characteristics to create the HL7® FHIR® resource.

Transcatheter-based aortic valve replacement vs. isolated surgical aortic valve replacement in 2020.

BACKGROUND: Based on the results of several recent randomized trials, European and American guidelines on valvular heart disease management have substantially expanded the indications for transcatheter aortic valve implantation (TAVI). We present an all-comer data on peri-operative risk profile and in-hospital outcomes from Germany for patients treated by TAVI or isolated surgical aortic valve replacement (iSAVR) in 2020, providing an opportunity to compare study data with data from daily clinical practice. METHODS: Data concerning all isolated aortic valve procedures performed in Germany in 2020 were retrieved from the mandatory nationwide quality control program. Expected mortality was calculated with the annually revised German Aortic valve score (AKL-score) based on the data of either catheter-based (AKL-CATH) or isolated surgical (AKL-CHIR) aortic valve replacement in Germany from the previous year (2019). RESULTS: In 2020 21,903 TAVI procedures (20,810 transvascular (TV; vs. 2019: 22.973; - 9.4%), 1093 transapical (TA; vs. 2019: 1413; - 22.6%)) and 6144 (vs. 2019 7905; - 22.5%) iSAVR were performed in Germany. Patients who received TAVI showed a significantly higher perioperative risk profile than patients undergoing iSAVR based on older age and more severe co-morbidities. While in-hospital mortality after TAVI (2.3%) was numerically lower than in 2019 (2.5%), this difference was not significant (p = 0.11). In-hospital mortality after iSAVR was identical in 2020 and 2019 (2.8%) and thus higher than after TAVI (p = 0.003), resulting in an observed expected mortality ratio of 1.02 after TAVI and 1.05 after iSAVR. After exclusion of the emergency procedures, in-hospital mortality did not differ significantly between the groups (TAVI 2.2% vs. iSAVR 1.9%, p = 0.26). CONCLUSION: Total numbers of both iSAVR and TAVI in Germany were lower in 2020 than in 2019, most likely due to the COVID-19 pandemic. However, the relative number of patients treated by TAVI as compared to iSAVR continues to increase. Despite older age and more severe comorbidities compared to patients undergoing iSAVR the in-hospital mortality after TAVI continued to decrease in 2020 and remains significantly lower than after iSAVR.

Rotational atherectomy via the transradial access: success rates, procedural parameters and complications.

Radial access is recommended for percutaneous coronary intervention (PCI), but rotational atherectomy remains frequently performed via femoral access. Analyzing the procedural parameters, success rate and complications of rotational atherectomy, performed via radial in comparison to femoral access. We retrospectively analyzed 427 consecutive patients undergoing rotational atherectomy. Procedural parameters and outcome were determined in 171 patients, scheduled for radial and compared to 256 patients with femoral access use. In the radial access group (74 ± 9 years, 84% male), the LAD was most frequently treated (49%). Sheath size was 7F in 59% and 6F in 41%, burr size was 1.5 mm in 46% and 1.25 mm in 14% of patients. A temporary pacemaker was inserted in 14%. Procedural success rate stood at 97%. Access site complications occurred in 4% of patients, which was significantly less frequent than in in 256 patients treated via femoral access (13% p = 0.003). Compared to radial access, femoral access was associated with the use of larger sheaths (p < 0.001), more frequent treatment of non-LAD vessels (58.2% vs. 44.4%, p = 0.013) and a higher rate of temporary pacemaker use (27%; p = 0.001). No differences could be seen in procedural success (p = 0.83) and burr size (p = 0.51). Femoral access (OR 3.33; 95% CI 1.40-7.93), and female sex (OR3.40 95% CI 1.69-6.63) were independent predictors for access site complications. For coronary rotational atherectomy, radial access has a high success rate with overall use of smaller sheaths, but of equally sized burrs as well as a significant lower rate of access site-related complications than femoral access.

Aortic valve replacement in Germany in 2019.

AIMS: Both 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 RESULTS: Data 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. CONCLUSION: After 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.

[The elderly patient with acute coronary syndrome]. / Der alte Patient mit akutem Koronarsyndrom ­ Konservative oder interventionelle Therapie?

The elderly patient with acute coronary syndrome (ACS) is often not treated on an evidence based basis due to age, previous illnesses and also an increased risk of bleeding. This applies to both drug and interventional therapy. However, valid data clearly show that elderly patients in particular benefit from guideline-adherent therapy, especially interventional revascularisation.

Left ventricular contraction patterns in Takotsubo Syndrome and their correlation with long-term clinical outcome.

BACKGROUND: Takotsubo Syndrome (TTS) is diagnosed in 1-2% of all patients presenting with acute coronary syndrome. Next to the typical apical manifestation, other locations of left ventricular contraction abnormality are possible, but their relationship to patient characteristics, clinical correlates as well as long-term outcome are poorly understood. METHODS & RESULTS: We retrospectively analyzed 126 patients presenting TTS. Cases were categorized according to left ventricular contraction abnormality patterns: typical apical pattern (71%, n = 89) vs. atypical patterns (29%, n = 37). Cases with typical TTS showed significantly higher levels of troponin I (3.12 ng/ml vs. 1.32 ng/ml, p = 0.013) and creatin kinase (CK) on admission (461 (±1207)U/l vs. 173 (±177) U/l, p = 0.03) as well as peak CK (973 (±2860)U/l vs. 301 (±328) U/l, p = 0.03) and more often ischemia related ECG changes (p = 0.02). Follow-up data was available for 85% of the patients. Median FU time was 4.4 years (IQR 1.4-7.7 years). All-cause mortality during follow-up was 39%, with no significant difference between patients with typical or atypical TTS (43% vs. 29%, p = 0.17). In multivariate logistic regression analysis, only anemia was predictive for long-term mortality (OR 3.93, 95%CI 1.02-2.08, p = 0.015). The majority of surviving patients (69%) reported good quality of life, even though only 56% reported being symptom-free. CONCLUSION: Patients with TTS have poor long-term prognosis with an overall mortality of 39.1% within 4 years and nearly half of all patients report persisting symptoms. Even though the apical contraction pattern is associated with higher elevation of serum markers for myocardial damage, it was not associated with higher long-term mortality.

European heart health survey 2019.

BACKGROUND: Rising life expectancy in the western population is increasing the prevalence of heart valve diseases (HVD). HYPOTHESIS: The level of awareness and initial screening for HVD should be sufficient. The potential impact of HVD on the daily activities of the elderly population in Europe might affect our society. METHODS AND RESULTS: A survey was conducted, including a total of 12 832 people aged ≥ 60 years in 11 European countries. Of all the people surveyed, 5.6% could correctly describe aortic valve stenosis. Most participants (75.0%) claimed they regularly do activities like sports or social activities, 29.2% provide care for a family member, friend or acquaintance. The majority (69.2%) would be prevented from doing these activities by symptoms such as chest pain, fatigue or shortness of breath. Having chest pain (76.5%) and shortness of breath (57.8%) were reasons for most people to arrange an appointment with their GP, whereas only 26.2% would visit a GP for fatigue. 67.6% of respondents claimed to be checked with a stethoscope by their GP occasionally, never, or only when they ask. The preferred treatment option for HVD is a keyhole procedure (45.8%), whereas open heart surgery would only be preferred by 7.0%. CONCLUSION: Knowledge about HVD is still low. Neither appointments with a GP driven by symptoms nor regular use of a stethoscope are a reliable guarantee for early diagnosis. With the over 60s in Europe playing an active role in social life, awareness campaigns and regular heart health checks may guarantee early diagnosis and treatment of HVD.

Lower mortality in an all-comers aortic stenosis population treated with TAVI in comparison to SAVR.

BACKGROUND: Within 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. METHODS: The 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. RESULTS: 19,317 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. CONCLUSION: TV-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.

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience.

AIMS: To 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 RESULTS: A 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. CONCLUSION: PASCAL 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.

Transvascular transcatheter aortic valve implantation in 2017.

BACKGROUND: Transcatheter 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. METHODS: We 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%). RESULTS: A 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). CONCLUSIONS: The 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. Overall 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%).