Michael Neuss

MitraClip® therapy in patients with end-stage systolic heart failure.

To assess the feasibility, short‐term durability and clinical outcomes of MitraClip® therapy for mitral regurgitation (MR) in patients with end‐stage heart failure and a severely reduced left ventricular (LV) ejection fraction.

Patient selection criteria and midterm clinical outcome for MitraClip therapy in patients with severe mitral regurgitation and severe congestive heart failure.

The implantation of a MitraClip (MC) is a new treatment modality for severe mitral regurgitation (MR) in patients whose condition is inoperable or who are at high conventional operative risk. This study reports the follow‐up data of patients implanted with an MC in our heart centre to find selection criteria for this procedure in patients with severe congestive heart failure.

Influence of pacing configurations, body mass index, and position of coronary sinus lead on frequency of phrenic nerve stimulation and pacing thresholds under cardiac resynchronization therapy

AIMSnPhrenic nerve stimulation (PNS) can affect, and in some cases considerably limit, the long-term success of cardiac resynchronization therapy (CRT) therapy. To address this common problem, the manufacturers of CRT devices offer a range of configurations aimed at preventing high left ventricular pacing thresholds (LVPTs) and PNS.nnnMETHODS AND RESULTSnIn 101 consecutive patients who had undergone implantation of a CRT system, we investigated prospectively the parameters LVPT and PNS threshold in relation to coronary sinus (CS) lead position, CS lead configuration, body position, and body mass index. With the configurations LV tip to right ventricular (RV) coil, LV tip to LV ring, and LV ring to RV coil, the LVPT and PNS threshold of patients with LV pacing were measured in the supine and left lateral body positions. The overall mean LVPT was lowest in LV tip to RV coil and highest in LV ring to RV coil configurations. The lowest PNS thresholds were measured in LV tip to RV coil and the highest in LV tip to ring configurations. The LVPT was not affected by body position and was stable in the standard supine and left lateral positions.nnnCONCLUSIONnFlexible LV pacing configurations are a useful feature of CRT systems for preventing PNS. The optimal LV pacing configuration should be determined on the basis of individual patient testing.

Elevated Mitral Valve Pressure Gradient After MitraClip Implantation Deteriorates Long-Term Outcome in Patients With Severe Mitral Regurgitation and Severe Heart Failure

OBJECTIVESnThis single-center study was performed to analyze the effect of an increased transvalvular gradient after the MitraClip (MC) (Abbott Laboratories, Abbott Park, Illinois) procedure on patient outcome during follow-up.nnnBACKGROUNDnPercutaneous transcatheter repair of the mitral valve with the MC device has been established as a novel technique for patients with severe mitral regurgitation and high surgical risk. This study investigated the influence of an increased pressure gradient after MC implantation on the long-term outcome of patients.nnnMETHODSnA total of 268 patients were enrolled, who received MC implantation between April 2009 and July 2014 in our institution (75 ± 9 years of age, 68% men, weight 76 ± 15 kg, median N-terminal pro-B-type natriuretic peptide 3,696 [interquartile range: 1,989 to 7,711] pg/ml, left ventricular ejection fraction 39 ± 16%, log European System for Cardiac Operative Risk Evaluation score 20% [interquartile range: 12% to 33%]). Pressure in the left atrium and left ventricle were measured during the procedure using fluid-filled catheters. The pressure gradients over the mitral valve were determined simultaneously invasively and echocardiographically directly after MC deployment. A Kaplan-Meier analysis was performed and correlated with the pressure gradients. We used a combined primary endpoint: all-cause-mortality, left ventricular assist device, mitral valve replacement, and redo procedure.nnnRESULTSnThe Kaplan-Meier-analysis showed a significantly poorer long-term-outcome in the case of an invasively determined mitral valve pressure gradient (MVPG) in excess of 5xa0mmxa0Hg at implantation for the combined endpoint (pxa0=xa00.001) and for all-cause mortality (pxa0= 0.018). For the echocardiographically determined MVPG the cutoff value was 4.4 mmxa0Hg. Propensity score matching was used to balance baseline differences between the groups. In a Cox model the increased residual MVPG >5 mmxa0Hg was a significant outcome predictor in univariate and multivariate analysis (hazard ratio: 2.3; 95% confidence interval: 1.4 to 3.8; pxa0=xa00.002, multivariate after adjustment for N-terminal pro-B-type natriuretic peptide, age, and remaining mitral regurgitation).nnnCONCLUSIONSnIt is recommended that the quality of the implantation result be analyzed carefully and repositioningxa0of the MC be considered in the case of an elevated pressure gradient over the mitral valve.

First use of cardiac contractility modulation (CCM) in a patient failing CRT therapy: clinical and technical aspects of combined therapies.

Cardiac contractility modulating (CCM) signals delivered by the OPTIMIZER System are being investigated as a treatment for medically refractory heart failure. Previous chronic studies of CCM have excluded patients with prolonged QRS and a cardiac resynchronization therapy (CRT) device. However, symptoms persist in more than 25% of these CRT patients. CCM may offer a therapeutic option for these non‐responders. Here we report the first use of CCM signals in a patient who did not respond to treatment with a CRT‐D device. We show that the implantation is technically feasible, that the OPTIMIZER and CRT‐D devices can coexist without interference and that acute haemodynamic and clinical improvements can be observed. The results suggest that systematic investigation of CCM treatment in CRT non‐responders is warranted.

Long-term survival after MitraClip® therapy in patients with severe mitral regurgitation and severe congestive heart failure: A comparison among survivals predicted by heart failure models

BACKGROUNDnThe aim of the study was to investigate mortality following transcatheter mitral valve repair with the MitraClip System (MC) (Abbott Vascular, Santa Clara, CA, USA) in patients with mitral regurgitation and moderate-to-severe symptomatic heart failure in comparison to mortality predicted by the Seattle Heart Failure Model (SHFM) and the heart failure calculator of the meta-analysis global group in chronic heart failure (MAGGIC).nnnMETHODS AND RESULTSnThis retrospective study included 194 consecutive patients, who received a MC implantation between 2009 and 2013 at our institution. The observed mortality was compared with that predicted by the SHFM and the MAGGIC after 1 year: 24% observed, 18% by SHFM (p=0.185) and 20.9% by MAGGIC (p=0.542). At 2 years: 32% observed vs. 33% by SHFM (p=0.919). The subgroup of patients with end-stage heart failure and N-terminal pro-B-type natriuretic peptide (NTproBNP) >10,000pg/ml (n=41) had significantly worse mortality after 1 year (49%) than predicted by SHFM (24%, p=0.034) and MAGGIC (24.8%, p=0.041).nnnCONCLUSIONnIn the overall patient cohort defined by 3+ to 4+ mitral valve regurgitation with New York Heart Association III and IV symptomatic heart failure, mortality following MC is consistent with that predicted by SHFM and MAGGIC for patients that are not at high risk. However, the subset of patients with severe heart failure defined by NTproBNP >10,000pg/ml had worse than predicted mortality and may not benefit from MC therapy, mainly due to a high 30-day mortality.

Long-term outcome of cardiac contractility modulation in patients with severe congestive heart failure

AIMSnCardiac contractility modulation (CCM) is a new form of electrical therapy in patients with congestive heart failure. Recently published clinical studies provide evidence of safety and improvements of exercise tolerance and quality of life. In this study, we investigated the impact of CCM on cardiac and all-cause mortality.nnnMETHODS AND RESULTSnFifty-four consecutive patients (age 63 ± 10 years, 91% male, left ventricular ejection fraction 23 ± 6%, baseline peak oxygen consumption 10.0 ± 4.8 mL/min/kg, N-terminal pro-B-type natriuretic peptide 5194 pg/mL, New York Heart Association III/IV) who underwent implantation of an Optimizer system (IMPULSE Dynamics, Orangeburg, NY, USA) at our centre between June 2003 and June 2010 were analysed retrospectively. Patients were followed every 3 months at our outpatient clinic. This study determined long-term outcomes of patients receiving CCM therapy. Twenty-four (44%) patients died during the follow-up period, which included 19 cardiac deaths (3 sudden cardiac deaths and 16 terminal cardiac pump failure deaths). The Kaplan-Meier analysis calculated a median survival time of 992 days (33.1 months) and a mean death rate of 18.4% per year. All-cause mortality for these patients was precisely predicted by the Seattle Heart Failure Model.nnnCONCLUSIONnCardiac contractility modulation appears to be a safe therapeutic option for advanced heart failure patients who have no other therapeutic options. Symptomatic improvement by CCM has been shown in earlier studies but our observational study suggests, for the first time, that there is no adverse effect of CCM on long-term survival.

MitraClip in CRT non-responders with severe mitral regurgitation

BACKGROUNDnSevere mitral regurgitation (MR) ≥ 3+ and left ventricular dyssynchrony in heart failure patients are markers of CRT non response. The MitraClip (MC) implantation is a therapy for MR ≥ 3+ in patients with high surgical risk of mitral valve reconstruction.nnnMETHODS AND RESULTSnWe investigated 42 patients with CRT and MR ≥ 3+ who received an MC device at our center. One and two year mortality rates were compared with the predicted mortality by Seattle Heart Failure Model (SHFM) and meta-analysis global group in chronic heart failure (MAGGIC), using the baseline characteristics of patients at the time of MC implantation. The median time interval between CRT and MC implantation was 20.1 (4.5-43.3) months. In 19 patients we observed a functional regurgitation with normal leaflets and in 23 patients a degenerative mechanism for mitral regurgitation. There was no change in mean QRS duration by biventricular pacing or MC implantation. The use of MC led to significant reductions in: median N-terminal pro-brain natriuretic peptide (NT-proBNP) level (pg/ml) from 3923 to 2636 (p = 0.02), tricuspid regurgitation pressure gradient (TRPG) from 43 to 35 mmHg (p = 0.019) and in left ventricular end-diastolic volume (LVEDV) by MC (p = 0.008). At the 2 year follow-up interval the all-cause mortality was 25%.nnnCONCLUSIONnMC implantation leads to an improvement of NT-proBNP level, TRPG and LVEDV in both functional and degenerative MR but does not influence QRS duration. Two year all-cause mortality was 25% and did not differ significantly from that predicted by SHFM and MAGGIC.

Impact of left ventricular systolic dysfunction on the outcomes of percutaneous edge-to-edge mitral valve repair using MitraClip.

Left ventricular systolic dysfunction (LVD) is associated with poor outcomes after mitral regurgitation (MR) surgery. MitraClip (MC) is a novel treatment option for MR patients with a high surgical risk. However, outcomes of LVD patients underwent MC remain unclear. In total of 194 patients after MC implantation, 75 patients (39xa0%) had severe LVD (LV ejection fraction ≤30xa0%). Patients with severe LVD were primarily male and also younger. Logistic euroSCOREs were comparable between the two groups. Functional MR was more common in patients with severe LVD, while New York Heart Association (NYHA) class was similar between the two groups. N-terminal pro-B-type natriuretic peptide (NT-proBNP) was significantly higher in patients with LVD. In addition to similar improvements in MR severity, NYHA class, and NT-proBNP levels, the survival rates were not different between patients with and without severe LVD. Among patients with severe LVD, the long-term survival rates were significantly lower in patients aged ≥75xa0years, those with NT-proBNP >5000xa0pg/mL, and those with atrial fibrillation (AF). In conclusion, severe LVD was not associated with the mortality after MC implantation. MC might be feasible and effective even in the patients with severe MR and low LVEF. However, we need to carefully observe severe LVD patients who are elderly, have a high NT-proBNP level, and have AF, as these might be considered high-risk subjects.

Interaction between renal function and percutaneous edge-to-edge mitral valve repair using MitraClip

BACKGROUNDnMitraClip (MC; Abbott Vascular, Menlo Park, CA, USA) is a treatment option for mitral regurgitation. Renal dysfunction is closely associated with cardiovascular disease. However, the influence of renal function in MC remains not fully understood. In this study, we aimed to clarify the association between renal function and MC.nnnMETHODS AND RESULTSnWe examined 206 consecutive patients who underwent MC and divided patients into 3 groups according to estimated glomerular filtration rate (eGFR), normal eGFR (≥60mL/min/1.73m2) (n=70), mild chronic kidney disease (CKD) (30-59mL/min/1.73m2) (n=106), and severe CKD (<30mL/min/1.73m2) (n=30). N-terminal pro-B type natriuretic peptide (NT-pro BNP) levels increased with decreasing eGFR. Kaplan-Meier curves revealed that the long-term survival rate significantly decreased with eGFR. After adjustment with the covariates, severe CKD was still associated with mortality. Improved renal function was observed in 30% and associated with baseline lower NT-pro BNP levels. Patients with improved renal function had higher chronic phase survival rate.nnnCONCLUSIONnRenal dysfunction is common in MC patients and the survival rate decreased with eGFR in association with increased NT-pro BNP levels. MC may improve renal function in approximately 30% of MC patients. Improved renal function is associated with lower NT-pro BNP levels and results in satisfactory prognosis. These results implies a close association between renal function and MC treatment.