Percutaneous treatment of mitral regurgitation in patients with impaired ventricular function: Impact of intracardiac electronic devices (from the German Transcatheter Mitral Valve Interventions Registry).

OBJECTIVES: To identify prevalence/impact of previous implantation of cardiac electronic devices (CEDs), such as cardioverter defibrillator (ICD) and cardiac resynchronization (CRT), in a group of MitraClip (MC) candidates with LVEF < 30%. BACKGROUND: MC therapy is nowadays often considered in patients with depressed left ventricular ejection fraction (LVEF%) and symptomatic severe secondary MR. METHODS: Data from the German Transcatheter Mitral Valve Interventions (TRAMIs) registry were analyzed. Patients with pre-procedural LVEF <30% were selected and divided according to the presence of CEDs. Pre-procedural, peri-procedural, and 1-year follow-up data were analyzed. RESULTS: Out of 689 MC patients, 235 had LVEF<30%. Of these, 23% (54/235) had CRT, 36.6% (86/235) ICD, and 40.4% (95/235) had no CEDs. Risk profile was similar (median STS score CRT 6.0 (IQR: 3.0-12.0); ICD 7.0 (IQR: 4.0-12.0); No-CED 6.5 (IQR: 2.0-10.0); p = 0.8). No procedural mortality was observed and hospital mortality was 5.6% in CRT, 2.3% in ICD, and 3.2% in No-CED (p = 0.5). At discharge, severe MV regurgitation was reported in 3.8% of CRT, 3.7% of ICD, and 1.1% of No-CED (p = 0.9). One year estimated survival (CRT 75.7%; ICD 75.8%; No-CED 78%; p = 0.94) and freedom from MACCE (CRT 73.6%; ICD 75.8%; No-CED 74.5%; p = 0.88) were similar. CONCLUSIONS: A third of patients have been already submitted to CEDs implantation at time of referral for MC therapy and 40% of those with severely depressed LVEF% arrive to MC therapy before ICD/CRT implantation. The presence of CED does not impair acute MC therapy success. Mid-term follow-up outcomes are similar in patients with and without CEDs.

Prognosis associated with redo cardiac resynchronization therapy following complete device and lead extraction due to device-related infection.

Aims: An increase in the number of cardiac resynchronization therapy (CRT) device implantations worldwide has led to a consequent increase in the number of infections associated with the device, making extraction of the CRT device inevitable. Redo CRT implantation after treatment and recovery following device extraction is challenging. This study aimed to evaluate the success rate, complications, and long-term prognosis of redo CRT implantation, including the rates of subclavian, cava, and coronary sinus (CS) vein thrombosis as well as re-infection. Methods and results: Between 2007 and 2014, 1712 lead extractions were performed in 537 patients with device-related infection at Heart Center Brandenburg. Of the 537 patients, 125 (23%) underwent CRT device and lead extraction, including extraction of the left ventricular lead from the coronary sinus. Of these 125, 62 (50%) patients underwent redo CRT implantation (mean age, 68 ± 10 years); 34 patients had coronary artery disease (CAD) while 28 had dilated cardiomyopathy (DCM). The mean left ventricular ejection fraction was 27% ± 7%. The mean QRS duration of the left bundle branch block was 158 (range, 147-162) ms, and 25 patients had atrial fibrillation (AF). All these patients were followed up for a median duration of 29.6 (range, 15-43) months. In 53 of the 62 patients (85%), the CRT system was successfully re-implanted; however, the original CS vein could be used again only in 28 (45%) patients. The all-cause mortality rate was 7.1% after 1 year, and it was significantly higher in patients whose N-terminal pro B-type natriuretic peptide level was ≥3,000 pg/mL (P < 0.001), those who were aged ≥64 years (P = 0.028), those who had CAD (P = 0.042) or chronic kidney insufficiency (P = 0.001), those with AF (P = 0.001) and those whose blood cultures were positive for Staphylococcus aureus (P = 0.014). Conclusion: Redo CRT implantation after device extraction owing to device-related infection has a low success rate and shows a higher rate of re-infection than that observed in patients who undergo CRT implantation for the first time. Further, patients whose blood cultures are positive for S. aureus show a particularly poor outcome.

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 (39 %) had severe LVD (LV ejection fraction ≤30 %). 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 ≥75 years, those with NT-proBNP >5000 pg/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.

Rotational angiography for preinterventional imaging in transcatheter aortic valve implantation.

OBJECTIVE: To evaluate the clinical value of 3D rotational angiography, as a tool for imaging and measuring 3D anatomy, coupled with transesophageal echocardiogram (TEE) as preinterventional imaging for transcatheter aortic valve implantation (TAVI) procedures. BACKGROUND: TAVI is a growing field in cardiology. An understanding of the 3D anatomy of the aortic root is crucial for patient selection and for the optimal planning and guidance of such procedures. Current techniques include 3D imaging (with MSCT MRI and 3D TEE) combined with multiplane TEE. Nevertheless, a gold standard of 3D imaging is yet not defined. 3D rotational angiography provides 3D anatomy information in the cathlab. Initially designed for nonmoving anatomical structures, one can adapt the protocol to temporarily minimize the heart anatomy motion during rotational angiography. METHODS: Ninety-nine consecutive patients (61 females, 38 males, age 80.9 ± 5.2 years) with symptomatic aortic stenosis underwent 3D rotational angiography to assess the anatomical suitability of potential TAVI candidates. 3D rotational angiography with a C-Arm (Innova 3100(IQ) , GE Healthcare, Chalfont St Giles, UK) was performed to create the 3D anatomy of the aortic root. Coronary angiography and pelvic vessel angiography were performed during the same examination. Measurements of the aortic annulus and the sinotubular junction were made on the 3D cross-sections and were compared to TEE. Radiation dose to the patient was also monitored. RESULTS: In all 99 patients, 3D rotational angiography was performed successfully with good imaging of the aortic root and measurements of the aortic annulus. In patients scheduled for SAPIEN valve implantation, the distances from the annulus to the coronary ostia were also measured. Of 99 patients, 80 subsequently underwent successful implantation. There is a good correlation to the TEE in the measured aortic annulus (22.13 ± 2.09 mm in rotational angio, 21.58 ± 2.09 mm TEE, Spearman r = 0.88, 95% IC [0.83;0.92], P < 0.0001) and sinotubular junction (26.19 ± 2.71 mm in rotational angio, 26.22 ± 2.73 mm TEE, Spearman r = 0.83, 95% IC [0.75;0.88], P < 0.0001). The effective dose is a fraction of the X-ray dose required for multi-slice computed tomography. CONCLUSION: Given that this technology is available in the cathlab at reasonable dose levels, 3D rotational angiography has proven to be a suitable preinterventional 3D imaging modality for TAVI procedures. Together, the raw angiographic data and the reconstructed 3D volume provide all the necessary anatomical information necessary for this procedure, including the measurements.

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

AIMS: Cardiac 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. METHODS AND RESULTS: Fifty-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. CONCLUSION: Cardiac 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.

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.

AIMS: Phrenic 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. METHODS AND RESULTS: In 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. CONCLUSION: Flexible 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.

Radiation exposure of patient and physician during implantation and upgrade of cardiac resynchronization devices.

BACKGROUND: Cardiac resynchronization therapy (CRT) is often associated with extended fluoroscopic exposure during placement of the devices. The objective of this study was to measure the radiation exposure sustained by different parts of the body of patients and operators during fluoroscopically guided cardiac resynchronization device implantation. METHODS: Dosimetry data were prospectively recorded in a series of 104 consecutive patients, who underwent resynchronization device implantation or upgrade in our cardiac catheterization laboratory. Five Chipstrate dosimeters were fixed to the patient's skin around the thorax (right and left paravertebral, right and left parasternal, and sternal positions), one dosimeter was attached to the forehead, and one to the pubis. The operator was equipped with one dosimeter on the forehead at eye level and a ring dosimeter was worn on the right hand. RESULTS: Based on the maximum radiation dose of 9.2 mSv measured at the operator's hand in a single implantation session, it might be recommended to conservatively limit the number of implantations to four per month (an annual limit value of 500 mSv). At a mean dose of 1.2 mSv, this number can be increased sevenfold. CONCLUSION: In patients, incipient deterministic radiation effects can theoretically be observed at dose area product >400 Gy*cm(2), a dose applied in 2.9% of CRT implantation procedures. Special follow-up programs are considered necessary for these patients and for operators, as the latter may be exposed over many years given the unknown long-term impact of chronic radiation exposure and the nature of current complex electrophysiology and device procedures.

Different impact of aortic regurgitation assessed by aortic root angiography after transcatheter aortic valve implantation according to baseline left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide.

Transcatheter aortic valve implantation (TAVI) is an alternative therapeutic option for severe aortic stenosis. Aortic regurgitation (AR) is commonly observed after TAVI and increases the mortality rate. We hypothesized that the influence of significant AR, defined as that more severe than mild AR, on survival rate after TAVI might differ according to the baseline left ventricular ejection fraction (LVEF) and N-terminal pro-B-type natriuretic peptide (NT-pro BNP) level. We categorized 856 patients who underwent transfemoral TAVI into 2 groups according to their baseline LVEF (<40 and ≥40%) and NT-pro BNP levels (≤5000 and >5000 pg/mL). Significant AR was observed in 92 patients (11%). Among patients with significant AR, the proportion of patients with CoreValve/EvolutR implantation was higher than that of patients with SAPIEN XT/3 implantation. Kaplan-Meier curves and the log-rank test showed that significant AR was not associated with 1-year mortality in patients with LVEF ≥40% and those with NT-pro BNP level ≤5000 pg/mL. On the other hand, it was significantly associated with a higher 1-year mortality in patients with LVEF <40% (p = 0.003) and those with NT-pro BNP level >5000 pg/mL (p = 0.011). Similarly, multivariate Cox regression analysis showed that the presence of AR was significantly associated with a higher 1-year mortality in patients with LVEF <40% [p = 0.005, hazard ratio (HR) = 3.626] and NT-pro BNP level >5000 pg/mL (p = 0.004, HR = 3.221). However, AR was not significantly associated with a higher 1-year mortality in patients with LVEF ≥40% and NT-pro BNP level ≤5000 pg/mL. Thus, the impact of significant AR on mortality after TAVI seems to be considerable in patients with reduced LVEF or high NT-pro BNP levels, but not those with preserved LVEF or low NT-pro BNP levels, suggesting that the influence of AR differs depending on the baseline LVEF and NT-pro BNP level.

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

OBJECTIVES: This 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. BACKGROUND: Percutaneous 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. METHODS: A 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. RESULTS: The 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 5 mm Hg at implantation for the combined endpoint (p = 0.001) and for all-cause mortality (p = 0.018). For the echocardiographically determined MVPG the cutoff value was 4.4 mm Hg. Propensity score matching was used to balance baseline differences between the groups. In a Cox model the increased residual MVPG >5 mm Hg was a significant outcome predictor in univariate and multivariate analysis (hazard ratio: 2.3; 95% confidence interval: 1.4 to 3.8; p = 0.002, multivariate after adjustment for N-terminal pro-B-type natriuretic peptide, age, and remaining mitral regurgitation). CONCLUSIONS: It is recommended that the quality of the implantation result be analyzed carefully and repositioning of the MC be considered in the case of an elevated pressure gradient over the mitral valve.

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

BACKGROUND: MitraClip (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. METHODS AND RESULTS: We 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. CONCLUSION: Renal 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.

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.

BACKGROUND: The 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). METHODS AND RESULTS: This 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). CONCLUSION: In 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.

Increased Prevalence of Diastolic Heart Failure in Patients with Rheumatoid Arthritis Correlates with Active Disease, but Not with Treatment Type.

OBJECTIVE: Although heart failure (HF) is a major cause of premature mortality, there is little information regarding its prevalence and associated risk factors in patients with rheumatoid arthritis (RA). In this study, we evaluated the prevalence of HF in a community-based RA cohort. Further, we investigated the effect of RA activity and present treatment on HF rate and cardiac structure. METHODS: A diagnostic workup for HF according to the European Society of Cardiology recommendations was performed in 157 patients with RA fulfilling the American College of Rheumatology/European League Against Rheumatism criteria (68% women, age 61 ± 13 yrs) from our outpatient clinic and in 77 age- and sex-matched controls. RESULTS: The prevalence of HF in patients with RA (24%) was unexpectedly high and differed significantly from the control sample (6%, p = 0.001). Diastolic HF was the dominant type (23% vs 6%), and clinical symptoms alone were of low diagnostic value. Active RA (28-joint Disease Activity Score ≥ 2.6: OR 3.4, 95% CI 1.3-9.8) was an independent risk factor of HF, as well as systemic inflammation (erythrocyte sedimentation rate > 16 mm/h: OR 5.4, 95% CI 2.1-16; C-reactive protein > 10 mg/l: OR 2.6, 95% CI 0.8-8.0) and RA duration > 10 years (OR 2.6, 95% CI 1.2-5.8). HF in RA was associated with concentric hypertrophy (48% vs 17%, p < 0.001) and reduced longitudinal strain (-17.2% vs -19.7%, p < 0.001). However, the prevalence of HF was equivalent between the treatment groups [conventional synthetic disease-modifying antirheumatic drugs (DMARD) 25%, tumor necrosis factor inhibitors 22%, other biological DMARD 27%]. CONCLUSION: Recognition of all diastolic HF in RA requires a complex diagnostic approach. Active rather than inactive RA places patients at a higher risk for HF, whereas influence of RA treatment on HF risk needs to be elucidated in further studies.

MitraClip in CRT non-responders with severe mitral regurgitation.

BACKGROUND: Severe 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. METHODS AND RESULTS: We 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%. CONCLUSION: MC 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.

[Pacemaker dependant and/or repetitive ICD therapies. How to solve the dilemma of lead extraction?]. / Schrittmacherabhängigkeit und/oder rezidivierende ICD-Therapien. Wie löst man dieses Problem nach Systemexplantation?

Bridging pacemaker-dependent patients or patients with repetitive ICD therapies after device and lead extraction is often challenging. Temporary pacing by means of an active fixation lead connected to an external reusable permanent pacemaker, or of a subxiphoidally implanted pacemaker with an epicardial lead is a safe option for bridging pacemaker-dependent patients after device and lead explantation. The wearable cardioverter defibrillator (WCD; LifeVest(®)) is a safe and effective tool for patients who need a continuous monitoring and ICD backup after device explantation.

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

AIMS: 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. METHODS AND RESULTS: This study included 163 implantation procedures in 157 patients between March 2009 and November 2012. The severe MR was caused by functional or organic valve disease. The patients had no surgical treatment option or dramatically increased surgical operative risk due to reduced LVEF or concomitant diseases. Three (2%) implantation procedures were unsuccessful. Eleven (7%) patients died during the first 30 days after MC implantation, and 9 (6%) additional patients died during the first 6 months, both groups mainly due to severe, therapy-resistant end-stage heart failure. The 111 patients who were followed up showed significant improvement in NT-proBNP, LVEF, NYHA class, 6 min walk test, and quality of life. Ten (6%) patients needed conventional heart surgery despite high operative risk due to persistent symptomatic MR after MC implantation. CONCLUSION: The interventional implantation of an MC is a new treatment for severe MR with acceptable periprocedural risk and results in clinical improvement in the majority. Patients with end-stage heart failure and an NT-proBNP value >10 000 pg/mL have a high mortality despite MC implantation, and their treatment should be based on a very individualized decision. Based on this experience, a clinical algorithm for patient selection is proposed.

Baseline vectorcardiography as a predictor of invasively determined acute hemodynamic response to cardiac resynchronization therapy.

AIMS: Identifying potential responders to cardiac resynchronization therapy (CRT) may be sometimes difficult and time consuming. Searching for a simple method, we chose vectorcardiography (VCG) for our study. The aim was to evaluate whether a VCG parameter can be used to predict invasively measured acute hemodynamic changes after CRT onset. METHODS AND RESULTS: Baseline VCG data were prospectively recorded just before initiation of CRT in a series of 126 consecutive patients (♂74 %, DCMP 60 %, ICMP 40 %, NYHA class III 100 %, QRS width 161 ± 27 ms, LV-EF 25 ± 6.5 %) prior to implantation at our specialized center. The time interval (TI) between the maximum vector and the end of the vector loop (initial description by Koglek W.) was correlated with acute hemodynamic change after CRT onset. Positive response to CRT was defined as an increase in dp/dt max >10 % or pulse pressure >5 %. According to these invasive hemodynamic parameters, 25 patients (20 %) were defined as non-responders. Using ROC analysis, the threshold value of the TI for responders was found to be 64 ms. TI is a predictor of acute hemodynamic response with a sensitivity of 96 %, a specificity of 76 %, a positive predictive value of 94 %, and a negative predictive value of 79 %. More non-responders are identified by TI than by using conventional QRS width in the 12-lead surface ECG. CONCLUSION: TI is a new method of evaluation based on baseline VCG analysis. It may be a useful diagnostic test for predicting acute hemodynamic response to CRT.