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Background: An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis., Methods: Patients with symptomatic HF with any left ventricular ejection fraction (LVEF) were randomized 1:1 to transcatheter shunt implantation versus a placebo procedure, stratified by reduced (≤40%) versus preserved (>40%) LVEF. The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days compared with a prespecified performance goal of 11%. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient worsening HF events, and change in quality of life from baseline measured by the Kansas City Cardiomyopathy Questionnaire overall summary score through maximum 2-year follow-up, assessed when the last enrolled patient reached 1-year follow-up, expressed as the win ratio. Prespecified hypothesis-generating analyses were performed on patients with reduced and preserved LVEF., Results: Between October 24, 2018, and October 19, 2022, 508 patients were randomized at 94 sites in 11 countries to interatrial shunt treatment (n=250) or a placebo procedure (n=258). Median (25th and 75th percentiles) age was 73.0 years (66.0, 79.0), and 189 patients (37.2%) were women. Median LVEF was reduced (≤40%) in 206 patients (40.6%) and preserved (>40%) in 302 patients (59.4%). No primary safety events occurred after shunt implantation (upper 97.5% confidence limit, 1.5%; P <0.0001). There was no difference in the 2-year primary effectiveness outcome between the shunt and placebo procedure groups (win ratio, 0.86 [95% CI, 0.61-1.22]; P =0.20). However, patients with reduced LVEF had fewer adverse cardiovascular events with shunt treatment versus placebo (annualized rate 49.0% versus 88.6%; relative risk, 0.55 [95% CI, 0.42-0.73]; P <0.0001), whereas patients with preserved LVEF had more cardiovascular events with shunt treatment (annualized rate 60.2% versus 35.9%; relative risk, 1.68 [95% CI, 1.29-2.19]; P =0.0001; P interaction <0.0001). There were no between-group differences in change in Kansas City Cardiomyopathy Questionnaire overall summary score during follow-up in all patients or in those with reduced or preserved LVEF., Conclusions: Transcatheter interatrial shunt implantation was safe but did not improve outcomes in patients with HF. However, the results from a prespecified exploratory analysis in stratified randomized groups suggest that shunt implantation is beneficial in patients with reduced LVEF and harmful in patients with preserved LVEF., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03499236.

Background: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality., Aims: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study., Methods: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team., Results: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001)., Conclusions: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

Background: In recent studies, a 5-stage cardiac damage classification in severe aortic stenosis (AS) based on echocardiographic parameters has shown to provide predictive value regarding clinical outcome. The objective of this study was to investigate the prognostic impact of a cardiac damage classification based on invasive hemodynamics in patients with AS undergoing transcatheter aortic valve replacement (TAVR)., Methods: A total of 1400 patients with symptomatic AS and full invasive hemodynamic assessment before TAVR were included. Patients were categorized according to their cardiac damage stage into five groups that are defined as: stage 0, no cardiac damage; stage 1, left ventricular damage; stage 2, left atrial and/or mitral valve damage; stage 3, pulmonary vasculature and/or tricuspid valve damage; stage 4, right ventricular damage., Results: 9.9% patients were classified as stage 0, 23.6% as stage 1, the majority of patients as stage 2 (33.5%), 23.1% as stage 3 and 10% as stage 4. One- and 4-year mortality were 10.1%/29.5% in stage 0, 16.1%/60.6% in stage 1, 17.3%/39.4% in stage 2, 22%/54.6% in stage 3, 27.1%/62.2% in stage 4 (p = 0.001/p < 0.001). The extent of cardiac damage was independently associated with increased mortality after TAVR (HR 1.16 per each increment in stage, 95% confidence interval 1.03-1.18; p = 0.018)., Conclusions: Cardiac damage staging in severe AS patients based on invasive hemodynamics appears to show strong association between the extent of cardiac damage and post-TAVR mortality. This staging classification provides predictive value and may improve risk stratification, therapy management and decision-making in patients with AS. Invasive Staging Classification of Cardiac Damage in Severe Symptomatic Aortic Stenosis has an Impact on Outcome after TAVR. (Top) Invasive staging criteria for cardiac damage in five stages using left ventricular end-diastolic pressure (LVEDP) for stage 1 (red), post-capillary wedge pressure (PCWP) for stage 2 (green), systolic pulmonary artery pressure (SPAP) for stage 3 (purple) and right atrial pressure (RAP) for stage 4 (yellow). The cake chart shows the distribution of the different stage in the whole cohort. (Bottom) Survival Analyses According to Stage of Cardiac Damage after Transcatheter Aortic Valve Replacement using Invasive Criteria. Kaplan-Meier plots comparing overall (left) and cardiovascular (right) 4-year survival showing with the more advancing stage a higher mortality rate.

Objectives: The aim of this study was to investigate reliability and accuracy of noninvasive measurement method by echocardiography compared to invasive measurement of systolic pulmonary artery pressure (SPAP) in a large cohort of aortic stenosis (AS) patients., Background: Pulmonary hypertension (PH) is common in patients with cardiac disease, especially in left heart disease like severe AS. Invasive measurement by right heart catheterization (RHC) is the gold standard to assess pulmonary pressures. Nevertheless, echocardiography is widely used in everyday practice for estimation of pulmonary pressures and diagnosing PH., Methods: A total of 1400 patients with AS and full invasive hemodynamic assessment by RHC and noninvasive measurements by Doppler echocardiography were included., Results: Mean patient age was 81.5 ± 6.8 years, and 46.3% were males. SPAP was 44.7 ± 15.1 mm Hg by echocardiography and 45.3 ± 15.2 mm Hg by RHC. Pearson's correlation coefficient was r = .820 (P < .0001). Bland-Altman analysis showed a bias of -0.56 mm Hg (95% limits of agreement -18.38 to + 17.26 mm Hg) and 80.6% measurement accuracy. Pulmonary hypertension defined by RHC as a mean PAP ≥25 mm Hg was reliably diagnosed via an echocardiographically measured SPAP of >40 mm Hg (82.2% sensitivity, 80.2% specificity, 83.1% positive predictive value, 79.2% negative predictive value)., Conclusions: In a large cohort of patients with severe aortic stenosis, we could demonstrate a very good correlation of SPAP between Doppler echocardiography and invasive RHC measurement. Pulmonary hypertension could be diagnosed by echocardiography with high sensitivity and specificity., (© 2020 Wiley Periodicals, Inc.)

Aims: Approximately 40% of severe aortic stenosis (AS) patients have a low-gradient (<40 mmHg) AS (LG-AS). The aim of this study was to investigate the invasively measured haemodynamic changes and long-term outcome after transcatheter aortic valve replacement (TAVR) in the subgroups of LG-AS., Methods and Results: A total of 600 LG-AS patients with haemodynamic assessment by left and right heart catheterisation were divided into three groups: normal-flow (NFLG-AS; n=296), paradoxical low-flow (PLFLG-AS; n=153), and classic low-flow (CLFLG-AS; n=151). Post TAVR, PLFLG-AS and CLFLG-AS showed a significant reduction in global afterload (p<0.005), as well as a significant elevation of stroke volume index (SVI), and left and right ventricular stroke work index (p<0.001). NFLG-AS was associated with an elevation of global afterload and a decrease of SVI (p<0.05). Overall survival was highest in NFLG-AS, followed by PLFLG-AS and CLFLG-AS. All subgroups experienced similar symptomatic improvement., Conclusions: NFLG-AS was the most prevalent form of LG severe AS and was associated with adequate left ventricular compensation and good prognosis. On the other hand, CLFLG-AS represents the heart failure with reduced ejection fraction (HFrEF) form of AS and was associated with the worst prognosis, whereas PLFLG-AS represents the heart failure with preserved ejection fraction (HFpEF) form of AS with intermediate prognosis. Both groups showed early haemodynamic reverse response after TAVR.

Objectives: The aim of this study was to investigate the prognostic impact and development of pulmonary hypertension (PH) in the different hemodynamic subtypes of PH in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR)., Background: PH is a frequent finding in patients with severe AS and predicts outcome after TAVR. Nevertheless, outcomes among PH subtypes and the impact of residual PH after TAVR are controversial., Methods: A total of 1,400 patients with symptomatic AS and full invasive hemodynamic assessment before and after TAVR were included. Patients were stratified into 4 groups: no PH (n = 658); isolated pre-capillary PH (n = 139), isolated post-capillary PH (Ipc-PH; n = 534), and combined post-capillary and pre-capillary PH (n = 69)., Results: The mean overall patient age was 81.5 ± 6.8 years, and 46.3% were men. Acute device success was achieved in 94.9%. Patients without PH showed significantly lower mortality rates compared with patients with PH (1 year, 13.8% vs. 22.4% [p < 0.001]; 4 years, 37.2% vs. 51.5% [p < 0.001]). Patients with pre-capillary PH showed 1.9-fold increased 1-year mortality and those with Ipc-PH showed 1.5-fold increased 1-year mortality compared with patients without pH (p = 0.001). No differences regarding survival were found among the subgroups. Only in patients with Ipc-PH, residual PH was associated with 2.1-fold increased mortality (p = 0.010). All patients benefited in terms of functional capacity after TAVR., Conclusions: Patients with pre-capillary PH and those with Ipc-PH showed significantly higher risk for death after TAVR compared with those without PH. Reversible PH had no benefit for survival except in patients with Ipc-PH. Hemodynamic stratification of PH is helpful for risk and response prediction in patients with AS undergoing TAVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We sought to assess the impact of different manifestations of heart failure (HF) at baseline on the short- and long-term outcomes of transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS)., Methods and Results: Of 361 patients undergoing TAVI between May 2013 and April 2015, 185 (51%) showed clinical signs of HF at the time of admission. HF was diagnosed as isolated left ventricular (LV) and biventricular in 63 (34%) and 122 patients (66%), respectively. Acute device success (VARC-2) was achieved in 97% of patients without HF, in all patients with LV HF, and in 97% of patients with biventricular HF. Follow-up for a median of 427 days revealed significantly poorer survival in patients with biventricular HF (1-year estimate, 72.1% [95% confidence interval, 64.0-80.2%]) than in patients with LV HF (84.5% [75.2-93.8%]; p = 0.0203) or no HF (94.3% [90.7-97.9%]; p < 0.0001). Survival in the latter two patient subgroups was statistically not different. A diagnosis of biventricular HF was associated with a hazard ratio of 2.62 (p = 0.0089) vs. no HF in the likelihood of death; NT-proBNP and the logistic EuroSCORE were not significantly associated with survival. Half of all deaths in patients with biventricular HF occurred within 42 days of TAVI., Conclusion: Biventricular HF is a strong predictor of mortality following TAVI for severe AS. AS in patients with LV HF should be treated without delay to avoid progression to biventricular HF. Patients with AS and biventricular HF should be monitored closely after TAVI to possibly prevent early death.

Background: Many candidates with ischaemic functional mitral regurgitation (FMR) have previously undergone coronary artery bypass grafting (CABG), in which transcatheter mitral valve repair can be reasonable for ameliorating the deteriorated hemodynamic and heart failure symptoms. We sought to elucidate the outcomes of MitraClip (MC) implantation in patients with symptomatic ischaemic FMR after CABG., Methods: We investigated clinical characteristics, outcomes and predictive impact of previous CABG on mortality in ischaemic FMR patients who underwent MC implantation from two high-volume centres in Germany., Results: We enrolled 159 patients who previously underwent CABG. Compared with a reference group that did not previously undergo CABG (n = 182), the cohort consisted of more elderly patients (75.0, standard deviation [SD] 7.7 versus 72.9, SD 9.6 years, p = 0.028), more men (84% vs. 69%, p < 0.001), and reduced tricuspid annular plane systolic excursion (14.0, SD 4.0, vs. 16.6, SD 4.6 mm, p < 0.0001). The CABG group showed similar outcomes regarding procedural success (91% vs. 94%, p = 0.24) and 30-day mortality (5.0% vs. 6.0%, p = 0.68), but worse survival after MC implantation (log-rank p = 0.019, hazard ratio 1.56 [95% confidence interval (CI) 1.08-2.26]). After propensity score matching (n = 224), the hazard ratio was 1.18 [95%CI 0.76-1.84] without statistical significance (p = 0.46)., Conclusions: Transcatheter mitral valve repair using the MC is a viable treatment option for patients with symptomatic ischaemic FMR after CABG. Although the baseline characteristics seemed to point to sick patients, CABG itself had only a modest impact on survival., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Introduction: Transcatheter edge-to-edge mitral valve repair using the MitraClip has been widely performed in surgical high-risk patients with reduced left ventricular systolic function and severe functional mitral regurgitation (FMR). Ischaemic heart disease is the leading aetiology of heart disease worldwide. We aimed to assess the clinical implications of ischaemic aetiology in patients with severe FMR who underwent MitraClip implantation., Methods and Results: From two high-volume centres in Germany, we retrospectively compared the clinical outcomes and clinical predictors of all-cause mortality after MitraClip implantation in patients with ischaemic (I-FMR) and non-ischaemic FMR (NI-FMR). In the overall FMR cohort (n = 575), there were 336 (58%) patients with I-FMR and 239 (42%) with NI-FMR. There was no significant difference in survival between the two groups (log-rank p = 0.78). In a multivariable Cox regression analysis of all-cause mortality, different predictors were observed for either group. In I-FMR patients, decreasing tricuspid annular systolic excursion [adjusted hazard ratio (HR adj ) 1.06, 95% confidence interval (95% CI) 1.01-1.14 /1 mm, p = 0.028] and increasing logistic EuroSCORE (HR adj 1.02, 95% CI 1.00-1.03, p = 0.037) were independent predictors, whereas in NI-FMR patients, NT-pro BNP (HR adj 1.05, 95% CI 1.02-1.08, p = 0.001) and age (HR adj 1.06, 95% CI 1.01-1.11, p = 0.013) were independently predictive of mortality., Conclusions: Despite the similar survival between ischaemic and non-ischaemic FMR, different predictors of all-cause mortality were demonstrated. Further clinical studies are mandated to focus on each FMR subgroup with stratification by ischaemic origin.

Aims: Conduction abnormalities (CA), in particular complete atrioventricular block (CAVB), requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS). However, the potential mechanisms are still incompletely understood. The objective of this retrospective study was to determine further predictors of CAVB after TAVI in patients without the known predictors., Methods and Results: This study included patients without prior CA/PPM who underwent TAVI of a balloon-expandable valve (Sapien or Sapien XT or Sapien 3). Of 563 patients (81.2 ± 6.9 years, 245 men [43.5%], logistic EuroSCORE 22.2 ± 14.1%, STS PROM 5.9 [3.4-8.0]) who were treated by TAVI at our institution between July 2008 and January 2016, 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18-3.55; p = 0.010) was identified as an independent predictor for new CAVB after TAVI. Moreover, patients with more pronounced TR presented with increased left and right ventricular overload (left ventricular (LV) end-diastolic diameter, LV end-diastolic pressure), pulmonary pressures, NT-proBNP, and prevalence of mitral regurgitation ≥II, whereas LV ejection fraction, TAPSE and cardiac output were decreased., Conclusions: PPM implantation is a frequent complication in patients undergoing TAVI. Increasing severity of TR seems to be a consequence of left and right ventricular overload caused by severe AS and is a significant predictor of new CAVB after TAVI., Condensed Abstract: Conduction abnormalities (CA) requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI). This study included patients without prior CA/PPM who underwent TAVI. Of 563 patients 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18-3.55; p = 0.010) was identified as an independent predictor for new CAVB. Therefore, in patients with moderate/severe TR utmost care should be taken to avoid procedural factors conducive to mechanical irritation of the conduction system, resulting in pacemaker dependency., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Aims: The recently released Medtronic CoreValve Evolut R 34 mm is the largest self-expanding transcatheter heart valve ever developed. Clinical data for this device size are scarce. We therefore aimed to evaluate the clinical performance and safety of the new device., Methods and Results: We report on the first 101 consecutive patients treated with transfemoral transcatheter aortic valve implantation (TAVI) using the 34 mm Evolut R device in a multicentre registry. Clinical parameters were determined before the procedure and echocardiography was performed at baseline and discharge. VARC-2 criteria were assessed at 30 days. Mean age was 80.7 years; mean logistic EuroSCORE was 19.8%. Procedural duration was 71.6 min. Echocardiography at discharge revealed a mean AVA of 2.0 cm2, moderate aortic regurgitation (AR) in 4.0% and severe AR in 1.0%. VARC-2 device success was achieved in 92.1%, while the early safety endpoint occurred in 11 patients (10.9%). New permanent pacemakers were implanted in 17 patients (18.7%). Thirty-day mortality was 2.0%, a stroke occurred in 3.0%, with a disabling stroke in one patient. The incidence of major vascular complications and bleeding was 1.0% and 5.0%, respectively., Conclusions: Initial experience with the new self-expanding CoreValve Evolut R 34 mm valve is characterised by high procedural success, good haemodynamic performance and a low early complication rate.

Background: In high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) diabetes mellitus (DM) is a common comorbidity. It is known to increase the risk of arteriosclerosis and adversely affect morbidity, mortality for all types of cardiovascular disease, and post-procedural outcome after percutaneous and surgical procedures. Moreover, DM is known to facilitate the genesis of renal failure (RF). Pre-existing RF seems to increase the rate of acute kidney injury (AKI), which is a powerful short- and midterm predictor of mortality in patients undergoing TAVR. Therefore, the aim of the present study was to investigate the impact of DM on AKI, short- and midterm prognosis after TAVR, especially in patients with pre-existing RF., Methods and Results: In 337(30%) of 1109 patients DM was documented. The incidence of RF at baseline (GFR <60mL/min) was statistically similar in both patient groups (no DM vs. DM: 54% vs. 61%; p=0.057). Also, the incidence of AKI stage 3 was similar in all patients (no DM vs. DM: 1.6% vs. 1.8%; p=0.799). There were no significant differences regarding the procedure-related complications according to VARC-2 and mortality between patients neither with nor without DM. Even after differentiating patients according to baseline renal function, similar incidence of AKI and midterm mortality were documented., Conclusion: In patients undergoing TAVR, neither in case of preserved nor impaired renal function, we couldn't find any evidence for influence of DM on overall acute and midterm prognosis nor the incidence of AKI., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: The study sought to assess outcomes of transcatheter mitral valve-in-valve implantation (TMVIV) for degenerated bioprostheses and transcatheter mitral valve-in-ring implantation (TMVIR) for failed annuloplasty rings according to access route and the Mitral Valve Academic Research Consortium (MVARC) criteria., Methods and Results: Twenty-four patients (72±13 years; eight men [33%]) underwent TMVIV (n=14) or TMVIR (n=10) for mitral regurgitation (MR; n=17) or stenosis (n=7) using balloon-expandable bioprostheses. Transapical (TA) access was chosen in 13, and transseptal (TS) access in 11 patients. MVARC technical success, device success and procedural success were 95.8%, 41.7% and 33.3%, respectively, with no differences between access routes. Cardiac output (CO) increased significantly by 1.1±0.8 l/min in TS patients, but not in TA patients (ΔCO=0.0±0.5 l/min; p=0.0051). Overall three-year survival was estimated at 57.6% (95% confidence interval: 33.9-81.3; TA 35.5% [5.2-65.9]; TS 90.9% [73.9-100]). Survival up to four years according to vascular access showed a clear benefit in patients treated transseptally (p=0.045)., Conclusions: Regardless of the access route, TMVIV/TMVIR was associated with high technical success yet impaired device success. In the long term, TA access had a significant adverse impact on survival.

Background: Histopathological analyses of debris captured by a cerebral protection system during transcatheter aortic valve replacement have been reported, but the origin of the captured debris was not determined and risk factors were not defined., Methods and Results: Embolic debris was analyzed from 322 filters used in a dual-cerebral-filter protection system implemented during transcatheter aortic valve replacement for 161 patients (mean age 81 years, 82 male [51%], logistic EuroSCORE 19% [interquartile range 12-31%]). The debris capture rate was high, with debris from 97% of all patients (156 of 161). No differences by filter location were found (brachiocephalic trunk 86% [139 of 161], left carotid artery 91% [147 of 161]; adjusted P=0.999). Five prevalent types of debris were identified: thrombus (91%), arterial wall tissue (68%), valve tissue (53%), calcification (46%), and foreign material (30%). Female sex (P=0.0287, odds ratio 1.364, 95% CI 1.032-1.812) and diabetes mellitus (P=0.0116, odds ratio 1.474, 95% CI 1.089-2.001) were significant risk factors for embolic debris. Additional analysis showed significantly more valve tissue in patients with predilation (P=0.0294). Stroke and transient ischemic attack rates were 0.6% each (1 of 161)., Conclusion: This study showed a high rate of embolic debris consisting of typical anatomic structures known to be altered in patients with aortic stenosis undergoing transcatheter aortic valve replacement. Female patients with diabetes mellitus have increased risk of embolic debris and should be protected by a cerebral protection system during transcatheter aortic valve replacement. Because valve tissue embolizes more often in patients with predilation, procedural planning should consider this finding. Both cerebral arteries (brachiocephalic trunk, left carotid artery) should be protected in the same way., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Objective: Histological analyses of debris captured by a cerebral protection system (CPS) during transcatheter valve-in-valve (VIV) procedures have not been reported., Methods: Fifteen consecutive patients with stenotic aortic (n=13) or mitral (n=2) surgical or transcatheter bioprostheses were treated with implantation of a transcatheter heart valve (THV) in the presence of a dual-filter CPS. Mean patient age was 75 years; mean logistic EuroSCORE was 31%. Filters were collected and histological assessment of debris was performed. Patients were followed clinically until discharge., Results: Debris captured by either or both filters was detected in all patients. Acute thrombus was the most common type of debris, found in all patients, followed in frequency by arterial wall tissue (n=12 patients (80%)), calcification (n=11 (73%)) and valve tissue (n=9 (60%)). Less frequently found were organised thrombus (n=5 (30%)), foreign material (n=4 (27%)) and myocardium (n=2 (13%)). A median of 123 debris particles per patient was detected, with a trend towards a greater median number of particles collected in proximal filters (78 vs 39, p=0.065). The average maximum particle diameter was 88 (range 56-175) µm, with a median of 20 particles ≥150 µm. No stroke or transient ischaemic attack (TIA) had occurred by the time of discharge (mean 8 days)., Conclusions: Transcatheter VIV procedures were associated with the release of particulate debris into the cerebral circulation in all patients. The type of debris suggests that debris originates predominantly from arterial and valvular passage of the THV., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Aims: To assess outcomes of TAVR as a rescue therapy in patients with cardiogenic shock due to acutely decompensated aortic stenosis., Methods and Results: Of 771 high-risk patients who underwent TAVR, 27 (3.5%; 78±9 years; 12 men) were treated emergently due to acutely decompensated aortic stenosis with cardiogenic shock. SAPIEN and CoreValve prostheses were implanted in 11 and 16 patients, respectively: the transfemoral access route was used in 25. Three patients died within 72 hours of successful valve deployment, and a further six died within a month, giving a 30-day mortality of 33.3%, which was significantly higher than in electively treated patients (7.7%, p<0.0001). Univariate predictors of 30-day mortality in cardiogenic-shock patients were baseline cardiac output <3.0 l/min, reduced cardiac power index, impaired renal function, and mechanical ventilation, as well as severe acute kidney injury after TAVR. Estimated one-year survival was 59.3% in emergently and 82.7% in electively treated patients (p=0.0009). However, 30-day landmark analysis showed no difference in cumulative survival between TAVR modalities. In cardiogenic-shock patients without concomitant reduced cardiac output and impaired renal function at baseline (n=22), estimated one-year survival was 72.7%., Conclusions: TAVR should be considered a reasonable rescue therapy in patients with cardiogenic shock secondary to decompensated aortic stenosis.

Background: Low-flow and low-gradient (LFLG) aortic stenosis (AS), which can occur with reduced or preserved left ventricular ejection fraction (LVEF), represents a challenging patient subset. Since outcomes in patients with LFLG AS are worse following surgical aortic valve replacement, we analyzed outcomes in patients after transcatheter aortic valve implantation (TAVI) in our large database., Methods and Results: Among 841 treated patients, a total of 676 patients with complete dataset of invasive right- and left-sided hemodynamics were analyzed. Patients were subdivided into normal flow, high-gradient AS (NFHG: dPmean >40 mmHg, LVEF > 50%), paradoxical LFLG AS (PLFLG: dPmean ≤ 40 mmHg, LVEF > 50%, stroke volume index ≤ 35 ml/m(2)), and classical LFLG AS (CLFLG: dPmean ≤ 40 mmHg, LVEF ≤ 30%). Finally, global hemodynamics and patient outcomes and were compared. Patients with CLFLG AS had a higher prevalence of comorbidities and much higher logistic euro SCORE (35.8 ± 21.7) compared to PLFLG AS (20.0 ± 13.1) and NFHG AS (17.0 ± 11.9). Despite high procedural success rates in all groups, patients with CLFLG AS demonstrated a much higher 30-day and 1-year mortality (NFHG/PLFLG/CLFLG 30-day: 5.9/9.6/18.3 %; 1-year: 11.4/22.4/38.2%). Nevertheless, nearly all survivors demonstrated an improvement of functional capacity (NYHA class) and a decrease of NTproBNP levels during the follow-up., Conclusion: The higher mortality in patients with CLFLG AS reflects an advanced disease state, possibly indicating a futile condition before TAVI. Nevertheless, high procedural success rates and a functional improvement in nearly all survivors support the concept of TAVI.

Aims: Hypertrophic obstructive cardiomyopathy (HOCM) with left ventricular outflow tract obstruction frequently involves a systolic anterior motion (SAM) of the anterior mitral leaflet. We hypothesised that SAM could be a new target for MitraClip therapy., Methods and Results: Three patients with HOCM were chosen for MitraClip therapy, due to significant SAM with subsequent mitral regurgitation. Invasive haemodynamic studies (right heart catheterisation, simultaneous transaortic pressure recording, and administration of nitroglycerine) were performed before and after MitraClip implantation, and a six-week follow-up was undertaken. MitraClip implantation was successfully performed with significant reduction of mitral regurgitation and SAM in all patients. Basal peak gradients (before clip: 65±25.5 mmHg; after clip: 7.7±5.0 mmHg) as well as provoked pressure gradients (before clip: 145.3±8.1 mmHg; after clip: 23.2±7.6 mmHg) were significantly reduced after MitraClip implantation. Right heart catheterisation data did not reveal major changes. At six-week follow-up, all patients presented in a persistently improved clinical state (NYHA Class I-II) with insignificant residual MR and continuously reduced LVOT gradients., Conclusions: This is the first catheter-based study targeting primarily a SAM in HOCM to reduce LVOT obstruction. The results prove the concept that SAM is more than an epiphenomenon in HOCM. Thus, SAM-induced obstruction might be a valuable target for the MitraClip.

Background: We compare the feasibility and outcomes of "off-label" transcatheter aortic valve implantation (TAVI) patients with a standard "on-label" TAVI population., Methods: A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria., Results: The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%)., Conclusion: Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.

Objectives: This study sought to investigate the prevalence of abnormal von Willebrand multimers (AbM) in patients undergoing transcatheter aortic valve replacement (TAVR) and the impact of TAVR on the underlying factor variances., Background: An association between the acquired von Willebrand syndrome (aVWS) and valvular aortic stenosis (AS) has been established in the past and surgical aortic valve replacement (SAVR) shown to lead to factor recovery. Prevalence and course of AbM in patients treated with TAVR though has not yet been described comprehensively., Methods: Ninety-five consecutive patients underwent TAVR at our institution. Hemostaseologic testing was performed before and up to 1 week after TAVR. Transvalvular and right heart hemodynamics as well as bleeding episodes were recorded and analyzed with descriptive statistics., Results: Baseline prevalence of AbM was 42% with an average high-molecular-weight multimer (HMWM) count of 16.2 ± 3.3%. Pressure gradients correlated significantly with the extent of HMWM deficiency (r = -0.63 [p < 0.0001]). Following valve implantation, HMWM increased proportional to the drop in mean pressure gradient and normalized in most of the patients. However, residual aortic regurgitation/leakage led to inferior HMWM recovery but prosthesis-patient mismatch (PPM) was rare and left HMWM uninfluenced. We saw no association of transfusion with AbM and 1-year mortality was unaffected by AbM., Conclusions: AbM in patients with AS undergoing TAVR is frequent. However, TAVR is capable of correcting AbM and therefore possibly aVWS in patients with AS. As opposed to SAVR, bleeding and transfusion requirement in TAVR patients was not associated with severe HMWM deficiency; PPM was rare and HMWM were uninfluenced by the procedure. Aortic regurgitation after TAVR adversely influenced HMWM recovery., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is accumulating evidence that up to 20% of the implanted devices after TAVI are associated with a significant degree of paravalvular leaks, which appear to be associated with a negative clinical outcome., Methods: A total of 355 patients with severe aortic valvular stenosis (AVS) were treated by TAVI (Corevalve n = 222, Edwards Sapien n = 133). Survival, NT-proBNP and the grade of PVL were quantified up to 12 months after implantation., Results: Technical success rate was 97.8%. Thirty-day mortality was 9.6%. Post-procedural transvalvular aortic regurgitation was seen only in a minority of cases (5%), whereas PVL were frequently observed (grade: <1+ in 58.2%, ≥1-<2 in 33.9%, and ≥2 in 7.9%). There was a clear relation-ship between PVL and adverse outcome (P < 0.001). After a transient increase, NT-proBNP showed a significant decline. Interestingly, a PVL ≥2+ was associated with a much higher rise in NT-proBNP compared to the other groups (P < 0.01), and a post-procedural increase in NT-proBNP by more than 1640 ng L(-1) within 5 days was associated with a significant increase in rate of death (P < 0.01)., Conclusions: TAVI is an efficient treatment option for high-risk patients with severe AVS. The incidence of PVL is an inacceptable clinical problem. Serial measurement of NT-proBNP can be used for risk-stratification in patients with a significant PVL. In general, PVL graded ≥2+ is associated with a dramatically increased 6-month mortality. Therefore, any action to reduce paraprosthetical regurgitation is highly recommended., (© 2013 Wiley Periodicals, Inc.)

Background: Transcatheter aortic valve implantation (TAVI) is a proven alternative to open heart surgery in elderly patients. Pulmonary hypertension (PH) is known as a significant risk factor in patients with severe aortic stenosis (AS) undergoing surgical aortic valve replacement. However, the prognostic impact of PH in high-risk patients undergoing TAVI is still unknown. The aim of this study was to gain more insight in the clinical outcome and mortality of patients with PH after TAVI., Methods and Results: Between July 2009 and September 2012, a total of 439 patients were treated by TAVI in conjunction with a complete invasive right heart study at our institution. Patients were divided into two groups with regard to their pulmonary arterial mean pressure (PAMP) before TAVI (A: PAMP < 25 mmHg and B: PAMP ≥ 25 mmHg). Patients with baseline PH had a significantly higher logES (A: 19.40 vs. B: 28.17 %; p < 0.001) and were more frequently in NYHA functional class IV (A: 15.4 vs. B: 25.1 %; p = 0.013). Invasive right heart data demonstrated an immediate improvement after TAVI in patients with PH. Despite a similar clinical benefit among survivors, 30-day and 1-year mortality were higher in patients with PH (30-day mortality: A: 4.8 vs. B: 10.4 %; p = 0.021, 1 year mortality: A: 13.9 vs. B: 23.4 %; p = 0.014)., Conclusions: Pulmonary hypertension is an independent risk factor for survival after TAVI. Nevertheless, TAVI leads to an acute improvement of nearly all invasively assessed variables in patients with PH, with a similar improvement in functional NYHA class compared to patients without PH, indicating a similar benefit among survivors.

Aims: Transcatheter aortic valve implantation (TAVI) is an accepted alternative for patients with severe aortic valve stenosis who cannot undergo surgery. Acute kidney injury (AKI) is a serious complication in any invasive cardiovascular intervention. The objectives of the study were to determine (i) the influence of kidney function before TAVI and (ii) the impact of changes in kidney function after TAVI, including acute kidney injury (AKI), on mortality., Methods and Results: A total of 540 patients undergoing TAVI were included. Patients were divided into three groups according to glomerular filtration rate (GFR) before TAVI (A: normal renal function i.e. GFR ≥60ml/min; B: impaired renal function i.e. GFR 30-59ml/min; C: severe impaired renal function i.e. GFR <30ml/min). Multivariate analysis showed a significant impact of GFR on mortality (p<0.0008). Subgroup analysis showed significant differences between the groups in 30-day (A: 5.4%, B: 9.0%, C: 25.0%) and 12-month mortality (A: 15.0%, B: 32.0%, C: 49%). Patients who had an increase in GFR after TAVI by more than 22% (p=0.0068) had an improved survival rate, whereas a decrease in GFR by more than 15% was associated with an increased mortality rate (p=0.0051). AKI occurred in 30 patients (5.6%), of which 22 patients (73.3%) died within 12months., Conclusion: Outcome is significantly related to pre-procedural kidney function. In addition, changes in kidney function after TAVI have a significant impact on mortality. Due to a very poor prognosis in patients with AKI, any effort to prevent this serious complication after TAVI needs to be taken., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Aims: Transcatheter mitral valve-in-valve implantation (TMViVI) for the treatment of failing mitral xenografts or recurrent mitral regurgitation after surgical ring implantation is an emerging therapy for patients in need of repeated mitral valve surgery. Despite the fact that these procedures have been shown to be feasible and effective, haemodynamic data after TMViVI are still limited in the literature., Methods and Results: Twelve patients (logES: 39.2±23.5%) were treated either by transapical (n=7) or transseptal (n=5) TMViVI, as a valve-in-valve (ViV, n=8) or valve-in-ring (ViR, n=4) implantation. Left atrial pressures (LAP), transmitral gradients and right heart haemodynamics (Swan-Ganz catheterisation) were studied before and after TMViVI. Procedural success was 100%, mitral regurgitation after TMViVI was mild in one, trace in five and absent in six patients. Thirty-day mortality was 0%. Left atrial pressures decreased significantly after valve implantation (before LAPmean/v-wave: 24.3/44.1 mmHg; after LAP/v-wave 15.9/22.1 mmHg; p<0.001) and cardiac output increased significantly. Transmitral gradients corresponded to mitral surface areas between 1.7 and 3.5 cm2, and were thus very acceptable in terms of the high surgical risk population., Conclusions: In conclusion, TMViVI with the balloon-expandable SAPIEN XT valve for ViV or ViR implantation is feasible with promising acute transmitral haemodynamic data. Nevertheless, sustained long-term performance remains to be demonstrated in the future.

Background: Transcatheter aortic valve implantation (TAVI) requires appropriate vascular access. Access site complications remain an important clinical issue. We report a new access site technique for management of puncture site visualization, reduction in use of contrast dye, in addition to several treatment options for management of vascular complications., Methods: Between August 2008 and November 2011, a total of 323 high-risk patients underwent a TAVI procedure at our institution. A new ipsilateral double-puncture technique was used in 189 patients. In case of any vascular complication the distal puncture was intentionally used for retrograde balloon blocking or stent implantation., Results: Overall mortality at 30 days was 8.7%. The rate of a major vascular complication was 7.1% (standard group 6.7% vs. double access group 7.4%, P = 0.59), resulting in death within 30 days in the standard group in 55.6% as compared to 21.4% in the double access group (P = 0.10), respectively. There was a numerical lower rate of surgical repair within the double access group as compared with the standard group (3.7% vs. 2.1%, P = 0.38). Occurrence of minor vascular complication was higher in the double access group (7.5% vs. 22.2%, P < 0.05). The use of contrast dye was significant lower with the new approach (200.9 ± 94.7 ml vs. 156.6 ± 79.0 ml, P < 0.05), resulting to a significant reduction of acute kidney injury (13.4% vs. 8.5%, P < 0.05). Occurrence of acute kidney injury was associated with a significantly higher 30-day mortality (20.6% vs. 7.3%, P < 0.05) irrespective of the puncture technique used., Conclusion: There was a significant reduction of acute kidney injury and contrast use with using the double access technique. The rate of minor vascular complication was higher within the double access group. In contrast, major vascular complication and subsequent surgical repair was numerically lower within the double access group. However, 30-day mortality was statistically not different with using the double access technique. Performing a distal puncture to the principal access site serves as a safety net to economize the use of contrast dye and to maintain an open lumen for percutaneous treatment of a vascular complication., (Copyright © 2012 Wiley Periodicals, Inc.)

Valve-in-valve implantation for degenerated surgical bioprosthetic valves is becoming an increasingly accepted approach in selected high-risk patients. In the past, valve-in-valve implantations have been mainly performed in aortic position and only rarely in mitral position. We describe the case of an 81-year-old female patient with severe mitral regurgitation of a degenerated Carpentier-Edwards biological prosthesis treated by transfemoral and transseptal implantation of a SAPIEN-XT valve., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study questioned whether transaxillary transcatheter aortic valve implantation (TAVI) is feasible as a true percutaneous approach using percutaneous closure devices., Background: Transaxillary TAVI is gaining increasing acceptance as an alternative to the transfemoral route; however, the access has always been done via surgical cutdown so far., Methods: Between August 2010 and September 2011, a total of 24 high-risk patients with severe aortic valvular stenosis underwent a percutaneous TAVI procedure by direct puncture of the axillary artery without surgical cutdown. For safety reasons and as a target for the puncture, a wire was advanced via the ipsilateral brachial artery. Moreover, a balloon was placed into the subclavian artery via the femoral artery for temporary vessel blockade before percutaneous vessel closure. Vascular closure was performed using either the ProStar XL system (Abbott Vascular Devices, Redwood City, California) or 2 ProGlide systems (Abbott Vascular Devices)., Results: The true percutaneous approach was successfully completed in all patients (14 left and 8 right axillary artery cases). Overall mortality at 30 days was 8.3%. Acute vascular closure device success was achieved in 17 patients (71%). Vascular closure device success rate was 100% for the ProGlide device and 37% for the ProStar device, respectively. Seven patients (29%) with failing closure devices were treated by endovascular stent graft implantation without the need for surgical repair. For the last 12 treated patients, direct closure was achieved in 11 patients., Conclusions: Direct puncture of the axillary artery for TAVI is feasible and safe if a wire is placed into the subclavian artery via the ipsilateral brachial artery., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Standard therapy of advanced mitral valve regurgitation currently consists of mitral valve reconstruction through heart surgery including heart-lung machine employment. Typically, a ring is implanted and a leaflet reduced, if necessary, to approximate the posterior and anterior mitral valve leaflets to each other. Because of high comorbidity among this patient population, new and less burdening catheter-based techniques have been developed. Clinical etiology of mitral valve regurgitation is divided into two categories: "structural" versus "functional". The MONARC system of the Edwards Lifesciences company consists of three components--distal stent, bridge with bioabsorbing coating, proximal stent--and is implanted into the coronary sinus. The underlying principle is an indirect annuloplasty of the mitral valve annulus resulting from resorption of the bridge coating and leading to a reduction and indirect tightening of the mitral valve annulus. The EVOLUTION I (EV I) study in patients suffering from functional mitral regurgitation to a degree between 2+ and 4+ revealed--12 months after the MONARC implantation--a mitral valve regurgitation reduction from 2.48 to 1.78. The EV I study found interaction of the foreshortening bridge with the coronary arteries in some patients. This problem is most widely excluded by previous computed tomographic or angiographic examinations in the ongoing follow-up study EV II. Direct annuloplasty is made possible in case of functional mitral regurgitation by using the Mitralign Percutaneous Annuloplasty System (MPAS) of the Mitralign company. In doing so, an improved coadaptation of the mitral valve leaflet is achieved by inserting three sutures into the posterior mitral valve annulus and subsequent plicating.The MitraClip of the Evalve company uses the principle of the edge-to-edge technique. In doing so, the posterior and anterior leaflets are joined by implanting a clip, resulting in a reduction of mitral regurgitation with two diastolic orifices. In contrast to strukthe other two procedures, the MitraClip can be used for both functional and structural mitral valve regurgitation. The EVEREST I study and the EVEREST II study, as far as it has already been published, show that this procedure is secure and its results are very positive. The previous results of all three procedures show that catheter-based techniques for treating high-risk patients suffering from mitral valve regurgitation arrive at positive results in part, so that possibly a real alternative to conventional heart surgery will be available in the future.