Influence of experience on procedure steps, safety, and functional results in edge to edge mitral valve repair-a single center study.

OBJECTIVES: We sought to determine the effects of experience on the Mitraclip® procedure steps as well as procedure safety and functional results. BACKGROUND: MR has proven deleterious in heart failure. Mitraclip® therapy evolved an important option in patients with severely reduced left ventricular function (LVEF). METHODS: Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results. RESULTS: The median logistic EuroScore was 32% (7-40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF <30%. Groups were homogeneous as to their baseline NYHA status and right heart catheterization data. Echocardiography data are comparable, albeit with a decreasing effective regurgitant orifice area (0.44 ± 0.21 group I vs. 0.34 ± 0.22 group III, P = 0.02). Frailty was less frequent and baseline 6 min walking test results improved from group I to group III. Duration of a first clip placement decreased from 106 ± 50 to 50 ± 21 min (P < 0.001). Total procedure time decreased from 221 ± 70 to 144 ± 68 (P < 0.001). The number of clips implanted increased from 66 to 79 (P = 0.02). MitraClip® implantation was effective in either group but the combined safety endpoint was reached less frequent in group III (P = 0.01). There was no difference in MACCE rate, 30 day- or intrahospital-mortality between groups. CONCLUSION: Safety and duration of procedure steps improved substantially with experience. MR reduction was sustained from the beginning without further improvement. Patient selection is a key factor for success. © 2016 Wiley Periodicals, Inc.

Left ventricular ejection fraction of < 20%: Too bad for MitraClip© ?

OBJECTIVES: This study sought to investigate whether the percutaneous mitral regurgitation (MR) reduction with the MitraClip® system in end-stage heart failure patients with a left ventricular ejection fraction (LVEF) of <20% also effects beneficial outcome or whether the underlying myogenic problem is leading and therefore of prognostic relevance. BACKROUND: The interventional treatment of functional mitral regurgitation (FMR) with the MitraClip® system could improve the clinical and hemodynamic outcome in patients with severely impaired left ventricular function. MATERIALS AND METHODS: Between 2011 and 2016, a total of 147 patients with FMR were treated with MitraClip® at our institution. The cohort was divided into two groups: LVEF ≥ 20% (N = 126) and <20% (N = 21). Follow-up assessments included exercise capacity, 6-min walk test, probrain natriuretic peptide-measurement (ProBNP), echocardiography and right heart catheterization. Only three patients with an LVEF ≥ 20% and one patient with an LVEF < 20% were lost for follow-up. RESULTS: In the vast majority of patients, a reduction from severe to mild MR was demonstrated with no difference between both groups (P = 0.422). At follow-up, both subgroups experienced similar improvements in exercise capacity and hemodynamics. Patients with an LVEF < 20% were on average 5.8 years younger, while mortality rates were comparable in both groups (P = 0.760). CONCLUSION: By careful selection, even patients in the end stage of advanced LV dysfunction as the result of the underlying myogenic problem and the additional harmful effects of the high volume loading due to the FMR can exhibit significant clinical and hemodynamic improvement after MitraClip© therapy.

Hemodynamic Improvement at Three Months after MitraClip® Treatment in End-Stage Heart Failure Patients with Functional Mitral Regurgitation.

BACKGROUND: Functional mitral regurgitation (FMR) is common in patients with advanced heart failure and impaired left ventricular function. The study aim was to examine functional and hemodynamic effects at three months after MitraClip® implantation in high-risk surgical patients with FMR. METHODS: A group of 93 patients was rejected for surgical treatment by heart-team decisions due to an inacceptable risk for conventional mitral valve surgery. Between October 2011 and May 2015, 89 of these patients (96%) were treated successfully with MitraClip implantation. A subsequent complete follow up was performed over three months in 32 patients with FMR, including pro-brain natriuretic peptide (pro-BNP) measurements, six-minute walk test, echocardiography, and right heart catheterization. RESULTS: The patients (mean age 73 ± 7 years) presented with a mean left ventricular ejection fraction (LVEF) of 32 ± 13%, and mitral regurgitation (MR) grade ≥3 in 30 of 32 cases (93%). All patients suffered from severe FMR and were highly symptomatic (NYHA functional class III or IV). The mean logistic EuroSCORE was 33%. MitraClip implantation resulted in a significant clinical improvement and reverse cardiac remodelling with a decrease in LV end-diastolic and LV endsystolic diameters, while LVEF was unchanged. In addition, a statistically relevant reduction of systolic, diastolic and mean pulmonary artery pressures (PAPsystolic -7.2 mmHg, p = 0.011; PAPdiastolic -4.5 mmHg, p = 0.003; and PAPmean -5.3 mmHg, p = 0.007) were measured, while the cardiac index (+0.3 l/min/m2, p <0.001) and cardiac output (+0.5 l/min, p <0.001) were increased significantly. The 30-day mortality was 8.6% (n = 8). CONCLUSIONS: Among the study population, MitraClip implantation led to clinical improvement, reverse cardiac remodeling, and a sustained hemodynamic benefit during the three-month follow up period.

Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures.

BACKGROUND: The choice of radiographic contrast media for use in patients at increased risk of contrast-induced nephropathy (CIN) is of ongoing interest. METHODS: The current study is a prospective, multicenter, randomized, double-blind design comparing the renal effects of the non-ionic, iso-osmolal agent, iodixanol, versus the non-ionic, low-osmolal agent, iopamidol, in 526 subjects with impaired baseline renal function (chronic kidney disease) and diabetes mellitus undergoing diagnostic and/or therapeutic coronary angiographic procedures. The co-primary end points were the peak increase in serum creatinine (SCr) and the incidence of CIN (increase > or =0.5 mg/dL) in SCr from baseline within 3 days of receiving contrast media. RESULTS: In 418 evaluable subjects with complete postcontrast media SCr data, the median peak increase in SCr in the iodixanol arm was 0.10 mg/dL, whereas in the iopamidol arm, the median peak increase was 0.09 mg/dL (P = .13). The overall CIN incidence was 10.5% (11.2% % in the iodixanol arm and 9.8% in the iopamidol arm, P = .7). The volume of contrast media, volume of saline administered, frequency of coronary interventional procedures, and severity of baseline kidney disease and of diabetes mellitus were similar between treatments. CONCLUSIONS: In the present study, the overall rate of CIN in patients with chronic kidney disease and DM undergoing coronary angiographic procedures was 10.5%. There was no significant difference between iodixanol and iopamidol in either peak increase in SCr or risk of CIN.

Coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD): diagnostic impact and clinical consequences in the German Cardiac CT Registry depending on stress test results.

To evaluate diagnostic impact of clinical use of coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD) and its consequences in daily practice for patient management, depending on stress test results in daily practice. Between 2009 and 2014 of a total population of 1352 patients of the German Cardiac Computed Tomography (CT) Registry who had previously undergone stress tests, CCTA visualizations were carried out on the coronary arteries with suspected stable CAD. Patients were divided into three groups according to stress test results: Group 1 with inconclusive (n = 178, 13.2%), Group 2 with ischemia in stress test (n = 372, 27.5%) and Group 3 without ischemia in stress test (n = 802, 59.3%). The test of preference was the stress electrocardiogram (ECG), which was performed more frequently in patients without ischemia in stress test as compared to those with ischemia (96.3% vs. 93.0%, p = 0.015). The incidence of detected obstructive CAD was lower in patients with suggested ischemia in stress test as compared to patients with inconclusive results (14.1% vs. 21.1%, p = 0.037). There was no difference in the incidence of an obstructive CAD in patients with and without ischemia in stress test (14.1% vs. 15.8%, p = 0.440). CCTA is a reliable, non-invasive option for ruling-out obstructive CAD irrespective of the stress test result.

Decreasing incidence of coronary heart disease in extreme obesity (BMI≥40)-A single centre experience.

AIM: The aim of our comprehensive single centre analysis was to evaluate the incidence of coronary heart disease (CHD) in extremely obese patients. METHODS AND RESULTS: Between 2005 and 2015 we investigated retrospectively 23,359 patients undergoing cardiac catheterisation in our institution. Patients were divided in six weight classes according to World Health Organization (WHO) criteria [1] (WHO, 2000). Cardiovascular risk factors, comorbidities, CCS stadium [2] (Cox and Naylor, 1992) and NYHA functional class [3] (The Criteria Committee of the New York Heart Association, 1994) were retrieved from electronic patient records. Using multivariable analysis the odds ratio for the target variable CHD with presence of >50% angiographic stenosis was ≥1 with regard to age (OR 1.049, 95% CI 1.045-1.052), male sex (OR 2.507, 95% CI 2.329-2.699), cardiovascular risk factors, atherosclerosis (OR 1.651, 95% CI 1.498-1.820), and presence of angina (OR 4.408, 95% CI 3.892-4.993). NYHA functional class I-IV, absence of angina (OR 0.818, 95% CI 0.729-0.918), and BMI≥40 (OR 0.592, 95% CI 0.494-0.709) resulted in an odds ratio of ≤1. Underweight patients had a higher (5.3%) and overweight (1.2%) and obese patients (class I 0.9% and II 1.1%) a slightly lower all-cause in-hospital mortality compared to extremely obese patients (1.6%). CONCLUSION: Severely obese patients treated in our hospital surprisingly showed a decreased incidence of CHD (46.1% in normal weight and 38.6% in extremely obese patients) while comorbidities increased CHD as expected. Although CHD burden was lower, obesity and associated comorbidities resulted in higher all-cause-in-hospital mortality.

Electrophysiological characteristics of septal hypertrophy in patients with hypertrophic obstructive cardiomyopathy and moderate to severe symptoms.

BACKGROUND: In hypertrophic obstructive cardiomyopathy, regional hypertrophy, myocardial replacement scarring, expanded interstitial fibrosis, and myocardial disarray can be found. The electrophysiological consequences of this substrate have not yet been investigated. Thus, the aim of this study was to assess the local electrophysiological characteristics of regional left ventricular (LV) septal hypertrophy. METHODS AND RESULTS: In 9 patients with hypertrophic obstructive cardiomyopathy, electroanatomic voltage mapping of the LV was performed during sinus rhythm to determine the regional voltage amplitude. In addition, the morphology of the regional bipolar endocardial electrogram was assessed. During multisite LV stimulation, the stimulus-to-V intervals in both septal hypertrophy and the lateral LV myocardium were determined. Bipolar electroanatomic voltage mapping revealed a significant reduction in regional voltage amplitude in septal hypertrophic areas compared with lateral LV areas without evidence of hypertrophy (0.41+/-0.24 versus 13.5+/-1.85 mV; P<0,001). Local bipolar electrogram analysis demonstrated fractionated and prolonged endocardial potentials in septal hypertrophic areas (with split potentials present in 6 patients) that were not revealed at lateral myocardial sites (110.1+/-24.6 versus 80.1+/-6.6 ms; P=0.005). The stimulus-to-V interval was significantly longer (62.9+/-10.3 versus 24.1+/-9.1 ms; P=0.005) in septal hypertrophic areas compared with the lateral LV. CONCLUSIONS: In LV regions with extensive hypertrophy, a marked reduction of bipolar voltage amplitude can be found, as well as local conduction delay and conduction block. This result is consistent with the findings of regional myocardial scarring and may contribute to the increased incidence of ventricular tachyarrhythmias in patients with hypertrophic obstructive cardiomyopathy.

Role of transcoronary ablation of septal hypertrophy in patients with hypertrophic cardiomyopathy, New York Heart Association functional class III or IV, and outflow obstruction only under provocable conditions.

BACKGROUND: Transcoronary ablation of septal hypertrophy (TASH) for hypertrophic cardiomyopathy seems to be an effective alternative to surgical myectomy. It remains a point of debate whether an outflow obstruction at rest is a necessary criterion for interventional therapy. METHODS AND RESULTS: TASH was compared in 45 consecutive patients with no resting gradient and a provocable gradient of > or =30 mm Hg (group I) and in 84 consecutive patients with a resting gradient of > or =30 mm Hg (80+/-33 mm Hg) (group II). At baseline, all patients were in NYHA functional class (FC) III or IV, unresponsive to medical treatment. Patients in group I were older (63+/-12 versus 55+/-17 years, P=0.005) and had a lower postextrasystolic gradient (110+/-44 versus 171+/-40 mm Hg, P<0.001). The groups were similar with respect to NYHA FC (3.1+/-0.3 versus 3.1+/-0.3), basal septal thickness (22+/-4 versus 23+/-3 mm), maximal oxygen consumption (13.1+/-4.6 versus 14.5+/-5.0 mL/kg per minute), and pulmonary artery mean pressure at workload (42+/-9 versus 42+/-10 mm Hg) (P>0.05). Median follow-up was 7 months after TASH. The 2 groups showed a significant and similar improvement in provocable obstruction (to 24+/-24 and 56+/-51 mm Hg, respectively), basal septal thickness (to 12+/-3 and 12+/-4 mm, respectively), NYHA FC (to 1.7+/-0.6 and 1.5+/-0.6, respectively), maximal oxygen consumption (to 16.0+/-5.3 and 16.6+/-6.0 mL/kg per minute, respectively), and pulmonary artery mean pressure at workload (to 36+/-9 and 34+/-9 mm Hg, respectively) (P>0.05). CONCLUSIONS: TASH seems to have beneficial clinical and hemodynamic effects in patients with either provocable or resting outflow obstruction.

Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy: the Cardiomyopathy Trial (CAT).

BACKGROUND: Patients with idiopathic dilated cardiomyopathy (DCM) and impaired left ventricular ejection fraction have an increased risk of dying suddenly. METHODS AND RESULTS: Patients with recent onset of DCM (< or =9 months) and an ejection fraction < or =30% were randomly assigned to the implantation of an implantable cardioverter-defibrillator (ICD) or control. The primary end point of the trial was all-cause mortality at 1 year of follow-up. The trial was terminated after the inclusion of 104 patients because the all-cause mortality rate at 1 year did not reach the expected 30% in the control group. In August 2000, the vital status of all patients was updated by contacting patients, relatives, or local registration offices. One hundred four patients were enrolled in the trial: Fifty were assigned to ICD therapy and 54 to the control group. Mean follow-up was 22.8+/-4.3 months, on the basis of investigators' follow-up. After 1 year, 6 patients were dead (4 in the ICD group and 2 in the control group). No sudden death occurred during the first and second years of follow-up. In August 2000, after a mean follow-up of 5.5+/-2.2 years, 30 deaths had occurred (13 in the ICD group and 17 in the control group). Cumulative survival was not significantly different between the two groups (93% and 80% in the control group versus 92% and 86% in the ICD group after 2 and 4 years, respectively). CONCLUSIONS: This trial did not provide evidence in favor of prophylactic ICD implantation in patients with DCM of recent onset and impaired left ventricular ejection fraction.

Magnetic-guided percutaneous coronary intervention enabled by two-dimensional guidewire steering and three-dimensional virtual angioscopy: initial experiences in daily clinical practice.

AIMS: Percutaneous coronary intervention (PCI) has been broadly established and often includes highly complex stenoses that require difficult navigation. The purpose of this study is to assess the feasibility of a new magnetic navigation system (MNS) to enable intracoronary guidewire deployment and PCI in daily clinical practice and to compare the 2D guidance to the virtual 3D angioscopy feature. METHODS AND RESULTS: We included 30 consecutive patients (pt) in whom 36 coronary arteries were PCI targets. Patients were randomized to guidewire steering by either 2D guidance or virtual 3D angioscopy (33%). In 31/36 (86%) interventions the MNS guidewire successfully passed the culprit stenosis and the procedure was accomplished by PCI. In 5/30 pt an MNS multivessel intervention was performed. Three of 5 unsuccessful procedures failed due to an unsuccessful recanalization of a subtotal chronic occlusion including 1 pt who required surgical intervention. In 2/36 procedures the magnetic guided intervention was performed effectively after prior conventional failure related to complex anatomy. The contrast medium amount needed to position the magnetic guidewire was 60 +/- 101 mL in 2D accomplished interventions vs. 14 +/- 15 mL in 3D procedures (p < 0.05). In 3 pt the MNS did not harm the implanted pacemaker or defibrillator system. CONCLUSION: Magnetic guided PCI is useful in selected patients. In our experience, success is less likely in evidence of a subtotal occlusion.

[Interventional treatment in hypertrophic cardiomyopathy]. / Hypertrophische Kardiomyopathie Myektomie, Schrittmacher, TASH oder ICD?

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease phenotypically expressed in the general population at about 0.2%. Annual mortality rate is about 1% in unselected patients, 3-6% in patients with severe symptoms, and 17% following resuscitation from ventricular tachycardia (VT)/ventricular fibrillation (VF). 50-80% of deaths are sudden. Beneath effective treatment in severe symptoms of heart failure (most common in midlife and beyond) the prevention of sudden death (most common in young patients) continues to be a major challenge. The highest risk has been associated with any of the following markers: 1. prior cardiac arrest or spontaneous sustained VTs, 2. a family history of premature HCM-related death, 3. extreme left ventricular hypertrophy (> or = 30 mm), 4. syncope, 5. multiple bursts of nonsustained VTs, 6. hypotensive blood pressure response to exercise, and 7. marked septal scarring (hyperenhancement in magnetic resonance imaging). Treatment options in patients with drug-refractory symptoms or increased risk of sudden death are surgical myectomy, transcoronary ablation of septal hypertrophy (TASH), dual-chamber pacing, ablation of atrial fibrillation (or the AV node), and the implantable cardioverter defibrillator (ICD). 1. Surgical myectomy effectively improves symptoms, hemodynamics and probably prognosis. Long-term results are well known, but patients' preference and the number of experienced surgical centers are fading. Randomized studies are missing. 2. TASH induces quite similar improvements in symptoms and hemodynamics. It is remarkably evaluated for a postprocedural follow-up of up to 10 years, and it is the preferred mode of treatment in patients. However, information on long-term prognosis, rhythmogenic effects and randomized studies are missing. For the prevention of sudden death, TASH has to be combined with an ICD. 3. Dual-chamber pacing was evaluated in randomized crossover studies, but symptomatic and hemodynamic improvements and patients' preference are substantially lower than for TASH. 4. The ICD has the potential to alter prognosis in secondary (class I indication) and primary prevention. HCM patients should undergo a risk stratification assessment. Prophylactic implants base on a clinical profile with two or more risk markers (sometimes one risk marker). 5. Ablation of atrial fibrillation or the AV node is indicated to improve symptoms in patients with fast ventricular rates despite medical treatment. For the prevention of sudden death, it has to be combined with an ICD.

Congenital anomalies of the coronary arteries: imaging with contrast-enhanced, multidetector computed tomography.

The objective of this study is to evaluate multidetector CT (MDCT) in detecting and characterizing anomalous coronary arteries. Forty-four patients with anomalies of the coronaries were selected from a total of 1758 individuals examined with ECG-gated 4- and 16-row MDCT including thinMIP, MPR and VRT post-processing. Twenty-eight patients showed origin and course anomalies of the central coronary segments, and in this subgroup 13 were judged as "malignant" because of interarterial courses between the aortic root and the pulmonary trunk, either of the right coronary artery (n=11) or the left coronary artery (n=2). Twelve non-hemodynamic anomalies were found, affecting the coronary origins only (n=10) or the peripheral vessels courses (n=2). Four arteriovenous fistulas were present, all of them with complex arterial feeders. Regardless of vessel anatomy, coronary opacification was always possible by means of the systemic contrast agent, and the aberrant coronary arteries were visualized synoptically in direct relation to the great mediastinal vessels. In contrast to MDCT, selective cannulation and final diagnosis was possible in only 11 of the 20 catheter angiograms performed (accuracy of 55.0%). In conclusion, its non-invasiveness and precise visualization makes MDCT the standard of reference for evaluating anomalous coronary arteries.