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MitraClip implantation has become the standard transcatheter mitral valve repair (TMVR) technique for severe mitral regurgitation (MR). However, approximately one third of patients have poor outcomes, with MR recurrence at follow-up. The aim of this study was to investigate whether quantitative analysis of mitral valve (MV) geometry on three-dimensional (3D) echocardiography can identify geometric parameters associated with the recurrence of severe functional MR (FMR) versus organic MR (OMR) at 6-month follow-up after TMVR using the MitraClip.Sixty-one patients with severe FMR (n = 45) or OMR (n = 16) who underwent transesophageal 3D echocardiography before and 6 months after TMVR were retrospectively analyzed. MV geometry was quantified using 3D echocardiography software. Vena contracta area (VCA) at 6-month follow-up was used to define two outcome groups: patients with good results with VCA 0.6 cmMR recurrence was found in 34% of all study patients (21 of 61). In patients with FMR, significant differences between MR 0.6 and MR ≥ 0.6 were found at baseline for tenting index (1.13 vs 1.23, P = .004), tenting volume (2.8 vs 4.0 ml, P = .04), indexed left ventricular (LV) end-diastolic volume (68.0 vs 99.9 ml/mMR recurrence after TMVR in patients with FMR is associated with advanced LV dilation and MV tenting before TMVR, which provides clinical implications for a point of no return beyond which progressive LV dilation with MV geometry dilation and tethering cannot be effectively prevented by TMVR. In contrast, no significant determinants of MR recurrence and progressive MV annular dilation could be identified in patients with OMR.

OBJECTIVES Little data have been published on the midterm effect of transapical/transfemoral-transcatheter aortic valve replacement (TA-/TF-TAVR) using the Edwards SAPIEN 3 valve (S3). We aimed to compare the outcomes after TA-/TF-TAVR utilizing the S3 (TA-/TF-S3) valve with those after surgical aortic valve replacement utilizing the rapid deployment Edwards INTUITY valve (RD-SAVR). METHODS Between March 2012 and April 2018, 122 patients with aortic stenosis underwent TA-S3, 77 patients underwent TF-S3 and 182 patients underwent RD-SAVR through partial sternotomy at our institution. We conducted clinical and echocardiographic midterm follow-ups. The primary outcomes of the study were the incidence of new pacemakers permanent pacemaker implantation (PPI), the occurrence of paravalvular leakage (PVL) and the hemodynamic performance of the valves. RESULTS All study groups were at intermediate surgical risk. The 30-day all-cause mortality and stroke rates in the TA-S3, TF-S3, and RD-SAVR groups were 4.1% and 1.6%, 3.9% and 2.6%, and 3.8% and 2.2%, respectively. The RD-SAVR group had significantly smaller PVL and PPI rates than did the TA-/TF-S3 group (p

The prevalence of aortic valve stenosis is increasing due to the continuously growing geriatric population. Data on procedural success and mortality of very old patients are sparse, raising the question of when this population may be deemed as "too old even for transcatheter aortic valve replacement (TAVR)." We, therefore, sought to evaluate the influence of age on outcome after TAVR and the impact of direct implantation.The data of 394 consecutive patients undergoing TF-TAVR were analyzed. Patients were divided into four age groups: ≤75 (group 1, n = 28), 76-80 (group 2, n = 107), 81-85 (group 3, n = 148), and85 (group 4, n = 111) years. Direct implantation was performed when possible according to current recommendations. Survival was evaluated by Kaplan-Meier analysis.Mortality at 30 days and 1 year was not significantly different between the four age groups (3.6 vs. 6.7 vs. 5.4 vs. 2.7% and 7.6 vs. 17 vs. 14.5 vs. 13%m respectively, log-rank p = 0.59). Direct implantation without balloon aortic valvuloplasty was more frequently performed on patients aged85 vs. ≤85 years (33.3 vs. 14.1%, p 0.001). the incidence of procedural complications frequently associated with advanced age (stroke, vascular complications) was not significantly increased in group 4.Outcome after TF-TAVR is comparable among different age cohorts, even in very old patients. Direct implantation simplifies the procedure and could therefore play a role in reducing the incidence of peri-interventional complications in patients of advanced age.HINTERGRUND: Die Prävalenz der Aortenklappenstenose steigt durch eine kontinuierlich wachsende geriatrische Bevölkerung. Daten über prozeduralen Erfolg sowie Mortalität von sehr alten Patienten sind gering, sodass sich die Frage stellt, wann diese Population „als bereits zu alt“ für einen Transkatheter-Aortenklappenersatz (TAVR) anzusehen wäre. Ziel dieser Studie war es, den Einfluss der direkten Implantation auf die Ergebnisse nach transfemoraler (TF-)TAVR bei Patienten in fortgeschrittenem Alter zu evaluieren.Dazu wurden die Daten von 394 konsekutiven Patienten nach TF-TAVR ermittelt. Die Patienten wurden in 4 Altersgruppen eingeteilt: ≤75 Jahre (Gruppe 1, n = 28), 76–80 Jahre (Gruppe 2, n = 107), 81–85 Jahre (Gruppe 3, n = 148) und85 Jahre (Gruppe 4, n = 111). Sofern es die aktuellen Empfehlungen erlaubten, wurde eine direkte Implantation durchgeführt. Das Überleben wurde mittels Kaplan–Meier-Analyse evaluiert.Zwischen den 4 Altersgruppen waren keine signifikanten Unterschiede der Mortalität nach 30 Tagen und nach einem Jahr zu verzeichnen (entsprechend 3,6 vs. 6,7 vs. 5,4 vs. 2,7 % und 7,6 vs. 17 vs. 14,5 vs. 13 %; p = 0,59 für Log-Rank-Test). Eine direkte Implantation ohne Ballonvalvuloplastie wurde bei Patienten85 Jahre häufiger durchgeführt als ≤85 Jahre (33,3 vs. 14,1 %; p 0,001). Die Inzidenz von häufig mit fortgeschrittenem Patientenalter assoziierten prozeduralen Komplikationen (Schlaganfall, vaskuläre Komplikationen) war in der Gruppe 4 nicht signifikant erhöht.In verschiedenen Alterskollektiven zeigen sich vergleichbare Ergebnisse nach TF-TAVR, dies gilt sogar für Patienten sehr hohen Alters. Die direkte Implantation kann die Prozedur vereinfachen und zu einer konsekutiven Reduktion der Inzidenz von periprozeduralen Komplikationen bei Patienten mit fortgeschrittenem Alter führen.

Background A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical–transcatheter aortic valve replacement (TA-TAVR). Methods Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort. Results The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality. Conclusion Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.

Multipoint pacing [Multipoint™ Pacing (MPP), Abbott] via a single left ventricular lead (Quartet™ LV lead, Abbott) improves acute left ventricular (LV) function and response to cardiac resynchronization therapy (CRT). Aim of this study was to examine additional benefits in terms of LV reverse remodeling and CRT response by activating MPP in responders and non-responders to conventional biventricular pacing (CONV). 43 consecutive patients receiving CRT (Quadra Assura MP™, Abbott) received LV dP/dtmax optimized CONV programming for 6 months. MPP programming with large anatomical electrode separation (> 30 mm) and basal LV1 pacing location was activated afterwards. Echocardiographic and clinical parameters were obtained at baseline, 6- and 12-month follow-up (FU). The response was defined as an improvement of LVESV ≥ 15% and super-response as improvement ≥ 30% relative to baseline. 41 patients completed FU (one died of non-cardiac cause and one was lost to FU) and after 6 months CONV, 26 patients (63%) were classified as CRT responders. With MPP, the response rate increased to 90% (p

Introduction Though transfemoral (TF) access has emerged as a gold standard access for patients with aortic stenosis who undergo transcatheter aortic valve implantation (TAVI), there has been no study that has characterized patients who cannot undergo TF access in detail. We aim to evaluate the contraindications for TF access, their incidence, classify them, and provide the outcomes of patients who failed to be TF candidates. Methods From 925 patients who underwent TAVI between February 2014 and May 2020 at our heart center, 130 patients failed to be TF candidates and underwent transapical-transcatheter aortic valve implantation (TA-TAVI). In this study, we included all those patients who failed to be TF candidates and underwent TA-TAVI using the third-generation balloon expandable valve (Edwards SAPIEN 3 valve [S3]) (116 patients; STS score 6.07 ± 4.4; age 79.4 ± 7). Results The incidence of patients unsuitable for TF access at our heart center was 14%. We classified this TAVI population into absolute contraindication for TF access n = 84 (72.5%) and increased interventional risk for TF access n = 32 (27.5%). After TA-TAVI of this specific population using S3, the in-hospital mortality and stroke were 1.7 and 1.7%, respectively. The vascular injury rate was 1.7%. We registered no paravalvular leakage ≥2. The pacemaker rate was 7.4%. The mean transvalvular pressure gradient was 8.7 mm Hg. Conclusion The incidence of patients who cannot undergo TF access or who are at high interventional risk is considerably high. TA-TAVI, supported with sufficient interventional experience and appropriate valve system, represents an excellent alternative for patients with distinct vasculopathy.

Background. Previous research reported adverse clinical outcomes in association with systemic inflammation (SI) after transcatheter aortic valve replacement (TAVR). However, data characterizing the impact of SI, as reflected by postprocedural routine inflammatory parameters (pRIP), on clinical outcome of patients undergoing TAVR are sparse. Objectives. In light of this, the present work aimed to analyze incidence and clinical significance of pRIP after transapical (TA) and transfemoral (TF)-TAVR. Methods and Results. Data of 81 high-risk consecutive patients undergoing TAVR in our center from 2017 to 2018 were analyzed in a retrospective manner. 40 out of 81 patients (49, 4%) were treated via TF access (group A) and 41 patients via TA access (group B). Incidence, cause, and amplitude of pRIP were analyzed in relation to pre- and peri-interventional data. Assessment of outcomes was conducted according to the valve academic research consortium (VARC-2). Postprocedural C-reactive protein (pCRP) and leucocytes (pL) were significantly increased in patients undergoing TA-TAVR (group B) vs. TF-TAVR (group A; 12.1 ± 9.7 vs. 22.1 ± 7.9 mg/dl, p p = 0.002); however, there was no significant difference regarding incidence of postprocedural fever (pF) ≥38.0°C (12.5% vs. 22%, p = 0.37). Furthermore, we observed a vast (though insignificant) trend towards a longer fever duration in group B vs. group A (9.9 ± 14.9 vs. 3.2 ± 5.9 hours, p = 0.06). Further analysis identified pCRP >30 mg/dl (hazard ratio (HR) 3.15, confidence interval (CI) 1.22–8.14, p = 0.018) and European System for Cardiac Operative Risk Evaluation (logistic EuroSCORE I (ES)) >20% (HR 2.95, CI 1.17–7.47, p = 0.02) as predictors of mortality; in this context, we also discovered a marginally significant trend for pL > 14/nl (HR 2.44, CI 0.97–6.14, p = 0.05). Multivariate analysis by use of the fisher`s exact test revealed a significant association between pCRP >30 mg/dl and ES >20% ( p 30 mg/dl, ES>20%, and pL > 14/nl are hallmark of adverse prognosis and require further investigation.

OBJECTIVES Patients scheduled for transcatheter aortic valve implantation (TAVI) treatment frequently present with concomitant aortic diseases, in which case they are usually considered to be at high interventional risk and, in particular, unable to undergo the transfemoral TAVI approach. Since the establishment of the ‘transfemoral first’ strategy for TAVI, there has been an evidence gap with regard to the outcomes of such patients. We aimed to evaluate the mid-term outcomes after transapical TAVI in patients with diverse aortic diseases. METHODS Fifty-five consecutive elderly patients (78.4 years; standard deviation: 8.6 years) at intermediate surgical risk with severe aortic stenosis and aortic diseases (porcelain aorta 36%, ascending aneurysm 15%, descending aneurysm 26%, type-B dissection 4%, aortic thrombus 7%, Leriche syndrome 4%, aortic kinking 11%, aortic ulcer 2%, previous aortic operation 20%, aortic elongation/tortuosity 4%) underwent transapical TAVI treatment between January 2011 and November 2019 at our institution. We used the second-and third-generation self- and balloon-expanding valves. The follow-up time was 92.6 patient-years. RESULTS The Society of Thoracic Surgery-Predicted Risk of Mortality score was 7% (standard deviation: 4%). The 30-day mortality and all-stroke rates were 6% and 4%, respectively. The median survival time was 24.9 months (95% confidence interval 17.6–32.3). The median time of freedom from a composite of death and cardio-cerebral adverse events was 24.3 months (95% confidence interval 11.9–36.8). The rate of moderate/severe paravalvular leakage was 2%. The pacemaker rate was 10%. No early or late aortic syndrome occurred. CONCLUSIONS Transapical TAVI is a safe method and shows very promising early and mid-term outcomes, without early/late aortic syndrome, in patients with aortic diseases for whom transfemoral TAVI as the first-line transcatheter method might be contraindicated or not feasible.

Highlights • Transcatheter heart valve size selection is still challenging. • The overlap between two different prosthesis sizes for borderline annuli remains. • Undersizing but overfilling improves sizing in borderline annulus cases. • Undersizing but overfilling decreases the postprocedural THV-pressure gradient. • Prospective studies are needed considering the TAVR expansion to younger patients., Background Current recommendations for valve size selection are based on multidimensional annular measurements, yet the overlap between two different transcatheter heart valve (THV) sizes remains. We sought to evaluate whether undersizing but overfilling eliminates the gray zones of valve sizing. Methods Data of 246 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable bioprosthesis with either conventional sizing and nominal filling (group 1 (NF-TAVR), n = 154) or undersizing but overfilling under a Less Is More (LIM)-Principle (group 2 (LIM-TAVR), n = 92) were compared. Paravalvular leakage (PVL) was graded angiographically and quantitatively using invasive hemodynamics. Results Annulus rupture (AR) occurred only in group 1 (n = 3). Due to AR adequate evaluation of PVL was possible in 152 patients of group 1. More than mild PVL was found in 13 (8.6%) patients of group 1 and 1 (1.1%) patient of group 2 (p = 0.019). Postdilatation was performed in 31 (20.1%) patients of group 1 and 6 patients (6.5%) of group 2 (p = 0.003). For patients with borderline annulus size in group 1 (n = 35, 22.7%) valve size selection was left to the physiciańs choice resulting in selection of the larger prosthesis in 10 (28.6%). In group 2 all patients with borderline annulus (n = 36, 39.1%) received the smaller prosthesis (LIM-TAVR). The postprocedural mean transvalvular pressure gradient was significantly higher in the NF-TAVR-group (11.7 ± 4 vs. 10.1 ± 3.6 mmHg, p = 0.005). Conclusion LIM-TAVR eliminates the gray zones of sizing and associated PVL, can improve THV-performance, reduce incidence of annular rupture and simplify the procedure especially in borderline cases.