Underweight is associated with inferior short and long-term outcomes after MitraClip implantation: Results from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

BACKGROUND: Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. AIMS: The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. METHODS AND RESULTS: From August 2010 until July 2013, 799 patients (age 75.3 ±â€¯8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). CONCLUSIONS: Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

AIMS: To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. METHODS AND RESULTS: Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. CONCLUSIONS: MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes.

Comparison of collagen-based vascular closure devices in patients with vs. without severe peripheral artery disease.

PURPOSE: To compare complication rates of a collagen-based vascular closure device (VCD) in patients with vs. without significant peripheral artery disease (PAD). METHODS: A total of 382 patients (268 men; mean age 64.6±10.8 years) undergoing either an endovascular procedure of the lower limb (PAD group, n=132) or a percutaneous coronary intervention (PCI group, n=250) via a common femoral artery access were enrolled in this prospective study if hemostasis was achieved using the collagen-based Angio-Seal. In the PCI group, significant PAD was excluded by measurement of the ankle-brachial index. In-hospital major complications (bleeding, large hematoma, pseudoaneurysm, vessel occlusion, dissection) were recorded. RESULTS: Similar and low rates of major complications were observed in both arms of the study: 2 (1.5%) major complications in the PAD group and 3 (1.2%) in the PCI group (p=1.0). There was no significant difference in efficacy of the VCDs in the groups (PAD group 99.2% vs. 100% in PCI group, p=0.35). CONCLUSION: Our study shows no significant differences in the rate of major complications after utilization of a collagen-based VCD for femoral artery access site closure in patients with severe lower limb PAD compared to those without; however, complications in the PAD group tended to be more severe, with the need for surgical repair.

Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a higher risk of neurological events for both the transfemoral and transapical approach than surgical valve replacement. Cerebral magnetic resonance imaging has revealed more new, albeit clinically silent lesions from procedural embolization, yet the main source and predominant procedural step of emboli remain unclear. METHODS AND RESULTS: Eighty-three patients underwent transfemoral (Medtronic CoreValve [MCV(TF)], n=32; Edwards Sapien [ES(TF)], n=26) and transapical (ES(TA): n=25) TAVI. Serial transcranial Doppler examinations before, during, and 3 months after TAVI were used to identify high-intensity transient signals (HITS) as a surrogate for microembolization. Procedural HITS were detected in all patients, predominantly during manipulation of the calcified aortic valve while stent valves were being positioned and implanted. The balloon-expandable ES prosthesis caused significantly more HITS (mean [95% CI]) during positioning (ES(TF), 259.9 [184.8-334.9]; ES(TA), 206.1[162.5-249.7]; MCV(TF), 78.5 [25.3-131.6]; P<0.001) and the self-expandable MCV prosthesis during implantation (MCV(TF), 397.1 [302.1-492.2]; ES(TF), 88.2 [70.2-106.3]; ES(TA), 110.7 [82.0-139.3]; P<0.001). Overall, there were no significant differences between transfemoral and transapical TAVI or between the MCV and ES prostheses. No HITS were detected at baseline or 3-month follow-up. There was 1 major procedural stroke that resulted in death and 1 minor procedural stroke with full recovery at 3-month follow-up in the MCV group. CONCLUSIONS: Procedural HITS were detected by transcranial Doppler in all patients. Although no difference was observed between the transfemoral and the transapical approach with the balloon-expandable ES stent valve, transfemoral TAVI with the self-expandable MCV prosthesis resulted in the greatest number of HITS, predominantly during implantation.

Hemodynamic assessment of paravalvular aortic regurgitation after TAVI: estimated myocardial supply-demand ratio and cardiovascular mortality.

A relevant (at least moderate) paravalvular regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is found in up to 20% of cases and associated with increased mortality. The ratio of the diastolic over the systolic pressure time integral (DPTI:SPTI) has been proposed to reflect an estimate of myocardial oxygen supply versus demand and the propensity for myocardial ischemia. We have now evaluated the potential of this ratio to predict PAR-associated cardiovascular mortality after TAVI, retrospectively analyzing data from 167 consecutive TAVI patients. PAR was graded angiographically, and the myocardial supply-demand ratio was estimated from the planimetric integration of the diastolic and systolic pressure-time area (DPTI and SPTI), respectively. PAR was observed in 113 patients (67%) and angiographically graded as mild in 89 (78.8%), moderate in 21 (18.6%) or moderate to severe in 3 (2.7%) cases. The DPTI:SPTI ratio decreased with increasing Sellers grade of PAR (P < 0.001). A DPTI:SPTI of ≤0.7 predicted cardiovascular mortality (area under the curve = 0.96). Cardiovascular mortality at 30 days and 1 yr was increased in patients with DPTI:SPTI ≤ 0.7 over those with DPTI:SPTI > 0.7 (42 vs. 2% and 63 vs. 3%, respectively; P < 0.001). In conclusion, DPTI:SPTI provides an excellent cutoff value of ≤0.7 for the prediction of PAR-associated mortality.

Suture-mediated arterial access site closure after transfemoral aortic valve implantation.

OBJECTIVES: To evaluate feasibility, safety and efficacy of percutaneous arterial access site closure after transfemoral, transcatheter aortic valve implantation (TF-TAVI) using a single, commercially available six French monofilament suture-mediated vascular closure device (VCD) in "preclosure" technique. BACKGROUND: Currently, TF-TAVI is evolving into a completely percutaneous procedure. However, percutaneous access site closure still remains a major technical challenge with room for improvement. METHODS: 94 of 144 consecutive patients underwent completely percutaneous TF-TAVI using following technique for access site closure: After puncture of the common femoral artery using fluoroscopy and contralateral angiography for guidance, the VCD was deployed prior further predilatation of the vessel and insertion of the large-bore introducer sheath. At the end of the procedure, the preloaded sutures were tied for final hemostasis and crossover angiography was used for postprocedural evaluation of the access vessel. RESULTS: Application of the VCD was technically successful in all cases, resulting in an efficient hemostasis with cessation of any bleeding within 10 min of final knot-tying in 83 of the 94 patients, and there was only one closure-failure with continuous bleeding despite prolonged manual compression requiring endovascular treatment. In addition, we observed four closure-related access vessel stenoses of hemodynamic relevance requiring endovascular treatment in three and surgical repair in one patient. However, interventional and surgical repair was not associated with death or irreversible end-organ damage and all patients recovered without sequelae. CONCLUSION: "Preclosure" of the arterial access site with a single six French suture-mediated VCD is relatively easy, safe and efficient method for access site closure after TF-TAVI which, along with ongoing profile reductions of TAVI devices, should further simplify and broaden the way toward a routine, completely percutaneous procedure.

Incidence, predictors, origin and prevention of early and late neurological events after transcatheter aortic valve implantation (TAVI): a comprehensive review of current data.

Transcatheter aortic valve implantation (TAVI) is a novel treatment option for patients with severe, symptomatic aortic valve stenosis considered inoperable or at high risk for surgical aortic valve replacement. Despite rapid adoption of this technology into clinical application, however, recent randomized controlled clinical trials have raised safety concerns regarding an increased risk of neurological events with TAVI compared to both medical treatment and conventional, surgical aortic valve replacement. Moreover, neuro-imaging studies have revealed an even higher incidence of new, albeit clinically silent cerebral lesions as a surrogate for procedural embolization. In this article, we review currently available data on the incidence, timing, predictors, prognostic implications and potential mechanisms of neurological events after TAVI.

Towards real-time cardiovascular magnetic resonance guided transarterial CoreValve implantation: in vivo evaluation in swine.

BACKGROUND: Real-time cardiovascular magnetic resonance (rtCMR) is considered attractive for guiding TAVI. Owing to an unlimited scan plane orientation and an unsurpassed soft-tissue contrast with simultaneous device visualization, rtCMR is presumed to allow safe device navigation and to offer optimal orientation for precise axial positioning. We sought to evaluate the preclinical feasibility of rtCMR-guided transarterial aortic valve implatation (TAVI) using the nitinol-based Medtronic CoreValve bioprosthesis. METHODS: rtCMR-guided transfemoral (n = 2) and transsubclavian (n = 6) TAVI was performed in 8 swine using the original CoreValve prosthesis and a modified, CMR-compatible delivery catheter without ferromagnetic components. RESULTS: rtCMR using TrueFISP sequences provided reliable imaging guidance during TAVI, which was successful in 6 swine. One transfemoral attempt failed due to unsuccessful aortic arch passage and one pericardial tamponade with subsequent death occurred as a result of ventricular perforation by the device tip due to an operating error, this complication being detected without delay by rtCMR. rtCMR allowed for a detailed, simultaneous visualization of the delivery system with the mounted stent-valve and the surrounding anatomy, resulting in improved visualization during navigation through the vasculature, passage of the aortic valve, and during placement and deployment of the stent-valve. Post-interventional success could be confirmed using ECG-triggered time-resolved cine-TrueFISP and flow-sensitive phase-contrast sequences. Intended valve position was confirmed by ex-vivo histology. CONCLUSIONS: Our study shows that rtCMR-guided TAVI using the commercial CoreValve prosthesis in conjunction with a modified delivery system is feasible in swine, allowing improved procedural guidance including immediate detection of complications and direct functional assessment with reduction of radiation and omission of contrast media.

Measurement of the aortic annulus size by real-time three-dimensional transesophageal echocardiography.

We sought to determine the level of agreement and the reproducibility of two-dimensional (2D) transthoracic (2D-TTE), 2D transesophageal (2D-TEE) and real-time three-dimensional (3D) transesophageal echocardiography (RT3D-TEE) for measurement of aortic annulus size in patients referred for transcatheter aortic valve implantation (TAVI). Accurate preoperative assessment of the dimensions of the aortic annulus is critical for patient selection and successful implantation in those undergoing TAVI for severe aortic stenosis (AS). Annulus size was measured using 2D-TTE, 2D-TEE and RT3D-TEE in 105 patients with severe AS referred for TAVI. Agreement between echocardiographic methods and interobserver variability was assessed using the Bland-Altman method and regression analysis, respectively. The mean aortic annuli were 21,7 ± 3 mm measured with 2D-TTE, 22,6 ± 2,8 mm with 2D-TEE and 22,3 ± 2,9 mm with RT3D-TEE. The results showed a small but significant mean difference and a strong correlation between the three measurement techniques (2D-TTE vs. 2D-TEE mean difference 0,84 ± 1,85 mm, r = 0,8, p < 0,0001; 2D-TEE vs. 3D-TEE 0,27 ± 1,14 mm, r = 0,91, p < 0,02; 2D-TTE vs. 3D-TEE 0,58 ± 2,21 mm, r = 0,72, p = 0,02); however, differences between measurements amounted up to 6,1 mm. Interobserver variability for 2D-TTE and 2D-TEE was substantially higher compared with RT3D-TEE. We found significant differences in the dimensions of the aortic annulus measured by 2D-TTE, 2D-TEE and RT3D-TEE. Thus, in patients referred for TAVI, the echocardiographic method used may have an impact on TAVI strategy.

Recurrence of Functional Versus Organic Mitral Regurgitation After Transcatheter Mitral Valve Repair: Implications from Three-Dimensional Echocardiographic Analysis of Mitral Valve Geometry and Left Ventricular Dilation for a Point of No Return.

BACKGROUND: 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. METHODS: 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 cm2 (MR < 0.6) and those with MR recurrence with VCA ≥ 0.6 cm2 (MR ≥ 0.6). RESULTS: MR 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/m2, P = .001), and VCA (0.71 vs 1.00 cm2, P = .003); no significant parameters of MR recurrence were found in patients with OMR. Multivariate analysis identified indexed LV end-diastolic volume as the strongest independent determinant of MR recurrence. Receiver operating characteristic analysis identified a tenting index of 1.185 (area under the curve 0.79) and indexed LV end-diastolic volume of 88 ml/m2 (area under the curve 0.76) to best discriminate between MR < 0.6 and MR ≥ 0.6. CONCLUSIONS: MR 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.

Towards real-time cardiovascular magnetic resonance-guided transarterial aortic valve implantation: in vitro evaluation and modification of existing devices.

BACKGROUND: Cardiovascular magnetic resonance (CMR) is considered an attractive alternative for guiding transarterial aortic valve implantation (TAVI) featuring unlimited scan plane orientation and unsurpassed soft-tissue contrast with simultaneous device visualization. We sought to evaluate the CMR characteristics of both currently commercially available transcatheter heart valves (Edwards SAPIEN™, Medtronic CoreValve®) including their dedicated delivery devices and of a custom-built, CMR-compatible delivery device for the Medtronic CoreValve® prosthesis as an initial step towards real-time CMR-guided TAVI. METHODS: The devices were systematically examined in phantom models on a 1.5-Tesla scanner using high-resolution T1-weighted 3D FLASH, real-time TrueFISP and flow-sensitive phase-contrast sequences. Images were analyzed for device visualization quality, device-related susceptibility artifacts, and radiofrequency signal shielding. RESULTS: CMR revealed major susceptibility artifacts for the two commercial delivery devices caused by considerable metal braiding and precluding in vivo application. The stainless steel-based Edwards SAPIEN™ prosthesis was also regarded not suitable for CMR-guided TAVI due to susceptibility artifacts exceeding the valve's dimensions and hindering an exact placement. In contrast, the nitinol-based Medtronic CoreValve® prosthesis was excellently visualized with delineation even of small details and, thus, regarded suitable for CMR-guided TAVI, particularly since reengineering of its delivery device toward CMR-compatibility resulted in artifact elimination and excellent visualization during catheter movement and valve deployment on real-time TrueFISP imaging. Reliable flow measurements could be performed for both stent-valves after deployment using phase-contrast sequences. CONCLUSIONS: The present study shows that the Medtronic CoreValve® prosthesis is potentially suited for real-time CMR-guided placement in vivo after suggested design modifications of the delivery system.

Undersizing but overfilling eliminates the gray zones of sizing for transcatheter aortic valve replacement with the balloon-expandable bioprosthesis.

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 physicians 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.

Combined Tricuspid and Mitral Versus Isolated Mitral Valve Repair for Severe MR and TR: An Analysis From the TriValve and TRAMI Registries.

OBJECTIVES: The aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation (TR) in the TriValve (Transcatheter Tricuspid Valve Therapies) and TRAMI (Transcatheter Mitral Valve Interventions) registries. BACKGROUND: Transcatheter mitral edge-to-edge valve repair (TMVR) has been shown to be successful in patients with severe MR. Lately, edge-to-edge repair has also emerged as a possible treatment for severe TR in patients at high risk for cardiac surgery. In patients with both severe MR and TR, the yield of concomitant transcatheter mitral and tricuspid valve repair (TMTVR) for patients at high surgical risk is unknown. METHODS: The characteristics, procedural data, and 1-year outcomes of all patients in the international multicenter TriValve registry and the German multicenter TRAMI registry, who presented with both severe MR and TR, were retrospectively compared. Patients in TRAMI (n = 106) underwent isolated TMVR, while those in TriValve (n = 122) additionally underwent concurrent TMTVR in compassionate and/or off-label use. RESULTS: All 228 patients (mean age 77 ± 8 years, 44.3% women) presented with significant dyspnea at baseline (New York Heart Association functional class III or IV in 93.9%), without any differences in the rates of pulmonary hypertension and chronic pulmonary disease. The proportion of patients with left ventricular ejection fraction <30% was higher in the TMVR group (34.9% vs. 18.0%; p < 0.001), while patients in the TMTVR group had lower glomerular filtration rates. At discharge, MR was comparably reduced in both groups. At 1 year, overall all-cause mortality was 34.0% in the TMVR group and 16.4% in the TMTVR group (p = 0.035, Cox regression). On multivariate analysis, TMTVR was associated with a 2-fold lower mortality rate (hazard ratio: 0.52; p = 0.02). The rate of patients in New York Heart Association functional class ≤II at 1 year did not differ (69.4% vs. 67.0%; p = 0.54). CONCLUSIONS: Concurrent TMTVR was associated with a higher 1-year survival rate compared with isolated TMVR in patients with both MR and TR. Further randomized trials are needed to confirm these results.

The role of imaging in percutaneous mitral valve repair.

Percutaneous, transcatheter mitral valve repair has recently been introduced and various strategies--loosely based on surgical techniques--are currently under clinical and preclinical evaluation. Since percutaneous mitral valve repair techniques are rather specific regarding both the underlying cause of mitral regurgitation and patient anatomy, careful preinterventional imaging using various techniques is required for appropriate patient selection and essential for procedural success. While echocardiography is the dominant imaging modality for determination of mitral regurgitation severity and etiology, other imaging modalities like contrast-enhanced multidetector computed tomography, magnetic resonance imaging, and fluoroscopy/angiography may play an important role in the preinterventional evaluation process. In addition, imaging is of utmost importance for procedural guidance and the combined use of various imaging modalities, commonly fluoroscopy and echocardiography, is needed in the catheterization laboratory to ensure safety and efficacy of mitral valve repair procedures. Finally, imaging is essential for an adequate patient follow-up aiming to control stable device positioning, persistency of the geometric modifications induced, and continuous reduction of mitral regurgitation. This review highlights the role of various imaging techniques during preinterventional evaluation, procedural guidance and follow-up in the setting of percutaneous mitral valve repair with special focus on edge-to-edge leaflet repair and indirect annuloplasty via the coronary sinus as the best-studied approaches to date.

Guidance of percutaneous transcatheter aortic valve implantation by real-time three-dimensional transesophageal echocardiography--A single-center experience.

Percutaneous transcatheter aortic valve implantation (TAVI) is an evolving interventional therapy for high-risk, non-surgical patients with severe, symptomatic aortic valve stenosis (AS). As a standard procedure, 2D transesophageal echocardiography has been used for the preinterventional assessment of the native valve and measurement of the aortic annulus as well as for intraprocedural guidance. Recently, a new matrix array, transesophageal probe for real-time three-dimensional echocardiography (RT3D-TEE) has been introduced. We applied this new technique to monitor percutaneous aortic valve implantation and described our initial experiences with this method in patients undergoing TAVI. We hypothesized that RT3D-TEE provides improved evaluation of the native aortic valve and annulus dimension due to unlimited scan plane orientation. This new technology should also enable accurate guiding of percutaneous cardiac interventions by providing immediate information on prosthesis position and function in real-time. In our preliminary clinical experience real-time three-dimensional transesophageal echocardiography (RT3D TEE) was demonstrated to provide improved guiding of percutaneous aortic valve replacement by superior spatial visualisation of the cardiac structures and facilitated the detection of procedure-related complications. Due to the advantages of real-time 3D TEE monitoring, this technique might improve the outcome of patients treated with percutaneous aortic valve replacement.

Feasibility of Transfemoral Aortic Valve Implantation in Patients With Aortic Disease and Simultaneous or Sequential Endovascular Aortic Repair.

OBJECTIVES: The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF-TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR. METHODS: Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed. RESULTS: Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months. CONCLUSION: TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.

Long-term outcome, survival and predictors of mortality after MitraClip therapy: Results from the German Transcatheter Mitral Valve Interventions (TRAMI) registry.

BACKGROUND: MitraClip therapy is increasingly used in patients deemed inoperable to treat severe mitral regurgitation (MR), but long-tern data is scarce. AIMS: The multicentre, industry-independent German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises the largest prospectively enrolled cohort of patients treated by MitraClip therapy. The current analysis is focusing on long-term mortality rates, cardiac rehospitalization and reintervention. METHODS AND RESULTS: Long-term follow-up (median time 1037 days) in the TRAMI registry was available for 722 patients treated at 20 German centres. Improvements in New York Heart Association (NYHA) functional class (I/II long-term: 65% vs. 1-year follow-up: 63.3%) and self-rated health-status (EuroQuol visual analogue scale [EQ VAS] long-term: 60 [50-70] vs. 1-year follow-up: 60 [50; 70]) were pertained over time. Estimated mortality rates by Kaplan-Meier method were 19.7% for 1-year, 31.9% for 2-year and 53.1% for 4-year follow-up without differences found for MR aetiology. Multivariable Cox-regression analysis identified previous aortic valve implantation (hazard ratio [HR] = 2.21; p < 0.0001), NYHA class IV (HR = 1.78; p < 0.001), prior cardiac decompensation (HR = 1.63; p < 0.001), creatinine > 1.5 mg/dl (HR = 1.63; p < 0.0001) and left ventricular ejection fraction < 30% (HR = 1.60; p < 0.001) as most predictive for long-term mortality. CONCLUSIONS: Long-term outcome in the TRAMI registry confirmed lasting clinical improvements and low intervention rates. Long-term mortality was strongly influenced by cardiac and non-cardiac co-morbidities and was found comparable for both MR aetiologies.

Recurrent infective endocarditis with uncommon Gram-negative Pasteurella multocida and Pseudomonas aeruginosa: a case report.

Infective endocarditis (IE) due to Gram-negative bacteria is a rare occurrence, with a relative frequency of less than 10% compared to that caused by Gram-positive bacteria. Herein is presented the fatal case of a 66-year-old man who had undergone mechanical aortic valve replacement 10 years previously, and developed aortic valve IE after sepsis with Pasteurella multocida caused by a cat bite at the left medial ankle. In addition, the patient suffered five months later from mitral and aortic valve endocarditis caused by Pseudomonas aeruginosa. Recurrent surgical therapy was mandatory. This unique case of recurrent Gram-negative IE shows that the condition must still be regarded as complex and often fatal, despite adequate medical and surgical treatment.

Impact of cardiac comorbidities on early and 1-year outcome after percutaneous mitral valve interventions: data from the German transcatheter mitral valve interventions (TRAMI) registry.

AIMS: The use of the MitraClip system has gained widespread acceptance for the treatment of patients with mitral regurgitation (MR) who are not suitable for the conventional surgery. This study sought to investigate the early and 1-year outcome after MitraClip therapy of patients with MR and cardiac comorbidities. METHODS AND RESULTS: Outcomes through 12-month follow-up of patients (n = 528) who underwent MitraClip implantation were obtained from the German transcatheter mitral valve interventions (TRAMI) registry. The majority of these patients (n = 409, 77.5 %) also suffered from coronary artery disease (CAD). Patients with a dilated cardiomyopathy (DCM, n = 65, 12.3 %) or concomitant valvular aortic disease (AV, n = 54, 10.2 %) were less frequent. Although the prevalent pathogenesis was functional MR, patients with DCM had significantly more frequent a functional MR (96.9 %) compared to patients with CAD (74.9 %) or AV (62.5 %, p < 0.001). Technical success was achieved in 97.5 % of patients. Procedural echocardiograms demonstrated in the vast majority of patients a reduction from severe MR III to mild MR I with no difference between the groups (p = 0.83). The peri-procedural complication rate was very low. At 30-day and 12-month follow-up, the majority of patients were in NYHA functional class II or lower. The rate of death, stroke, and myocardial infarction (MACCE) was comparable in the three patient groups during 12-month follow-up (DCM 26.9 %, CAD 30.3 % and AV 27.5 %, p = 0.85). CONCLUSIONS: The MitraClip implantation is feasible and safe even in high-risk patients with MR and cardiac comorbidities.