Katharina Hellhammer

Initial clinical experience using the EchoNavigator®-system during structural heart disease interventions

AIMnTo present our initial clinical experience using this innovative software solution for guidance of percutaneous structural heart disease interventions.nnnMETHODSnLeft atrial appendage, atrial septal defect and paravalvular leak closure, transaortic valve repair and MitraClip(®) procedures were performed in the catheter laboratory under fluoroscopic and echocardiographic guidance. The two-dimensional and three-dimensional images generated by the transesophageal echocardiography probe were interfaced with the fluoroscopic images in real-time using the EchoNavigator(®)-system.nnnRESULTSnThe application of the novel image fusion technology was safe and led to a better appreciation of multimodality imaging guidance due to improved visualization of the complex relationship between catheter devices and anatomical structures.nnnCONCLUSIONnThe EchoNavigator(®)-system is a feasible and safe tool for guidance of interventional procedures in structural heart disease. This innovative technology may improve confidence of interventional cardiologists in targeting and positioning interventional devices in order to increase safety, accuracy, and efficacy of percutaneous interventions in the catheter laboratory.

Percutaneous mitral valve repair using the MitraClip® system in patients with anemia

BACKGROUNDnPatients with anemia show a negative outcome in percutaneous coronary intervention, transcatheter aortic valve replacement and cardiac surgery. The impact of anemia on periprocedural major adverse cardiac and cerebrovascular events (MACCE) and mortality in patients undergoing treatment of severe mitral regurgitation (MR) with percutaneous mitral valve repair using the MitraClip system is not known.nnnOBJECTIVEnTo assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with anemia.nnnMETHODS AND RESULTSn80 patients with severe and moderate-to-severe MR were included in this open-label observational single-center study. Anemia was prevalent in 51.3% of patients (n=41). MitraClip devices were successfully implanted in 97.6% (n=40) of patients with anemia and in 97.4% (n=38) of patients without anemia (p=0.971). Periprocedural MACCE occurred in 4.9% (n=2) of patients with anemia and 5.1% (n=2) of patients without anemia (p=0.959). Thirty-day mortality was 2.4% (n=1) in patients with anemia and 5.1% (n=2) in patients without anemia (p=0.611). Follow up of up to 12 months showed a significant improvement of NYHA class and quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire in both groups. One-year survival was 80.5% in patients with anemia and 84.6% in patients without anemia (p=0.634).nnnCONCLUSIONnMitral valve repair with the MitraClip system can be performed safely and efficiently in patients with anemia. Anemia does not affect clinical outcome and quality of life in patients undergoing mitral valve repair.

Influence of percutaneous mitral valve repair using the MitraClip® system on renal function in patients with severe mitral regurgitation

Background: In patients with mitral regurgitation (MR), changes in cardiac stroke volume, and thus renal preload and afterload may affect kidney function. Percutaneous mitral valve repair (PMVR) with the MitraClip® system can be a therapeutic alternative to surgical valve repair. The influence of MitraClip® therapy on renal function and clinical outcome parameters is unknown. Methods and Results: Sixty patients with severe MR underwent PMVR using the MitraClip® system in an open‐label observational study. Patients were stratified according to their renal function. All clips have been implanted successfully. Effective reduction of MR by 2–3 grades acutely improved KDOQI class. Lesser MR reduction (MR reduction of 0–1 grades) led to worsening of renal function in patients with pre‐existing normal or mild (KDOQI 1–2) compared to severe (KDOQI 3–4) renal dysfunction. Reduction of MR was associated with improvement in Minnesota Living with Heart Failure Questionnaire (MLHFQ), NYHA‐stadium, and 6‐minute walk test. Conclusion: Successful PMVR was associated with an improvement in renal function. The improvement in renal function was associated with the extent of MR reduction and pre‐existing kidney dysfunction. Our data emphasize the relevance of PVMR to stabilize the cardiorenal axis in patients with severe MR.

Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip® System in Patients with Diabetes Mellitus

Background Patients with diabetes mellitus show a negative outcome in percutaneous coronary intervention, aortic valve replacement and cardiac surgery. The impact of diabetes on patients undergoing treatment of severe mitral regurgitation (MR) using the MitraClip system is not known. We therefore sought to assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with diabetes mellitus. Methods and Results We included 58 patients with severe and moderate-to-severe MR in an open-label observational single-center study. Ninteen patients were under oral medication or insulin therapy for type II diabetes mellitus. MitraClip devices were successfully implanted in all patients with diabetes and in 97.4% (nu200a=u200a38) of patients without diabetes (pu200a=u200a0.672). Periprocedural major cardiac adverse and cerebrovascular events (MACCE) occurred in 5.1% (nu200a=u200a2) of patients without diabetes whereas patients with diabetes did not show any MACCE (pu200a=u200a0.448). 30-day mortality was 1.7% (nu200a=u200a1) with no case of death in the diabetes group. Short-term follow up of three months showed a significant improvement of NYHA class and quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire in both groups, with no changes in the 6-minute walk test. Conclusions Mitral valve repair with the MitraClip system is safe and effective in patients with type II diabetes mellitus. Trial Registration MitraClip Registry NCT02033811

Left ventricular contrast injection with rotational C-arm CT improves accuracy of aortic annulus measurement during cardiac catheterisation

AIMSnIntroduction of a novel contrast injection protocol during rotational C-arm CT (RCT) in cardiac catheterisation of patients with aortic stenosis for aortic root assessment.nnnMETHODS AND RESULTSnFifty-two patients underwent RCT imaging with contrast injection performed either into the aorta (Ao-RCT, n=25) or into the left ventricle (LV-RCT, n=27). Aortic annulus diameters were assessed in a multiplanar reconstruction view and compared with corresponding multidetector computed tomography (MDCT). LV contrast injection additionally enabled measurement of the left ventricular outflow tract (LVOT). LV-RCT improved the accuracy of annulus measurements and correlated well with MDCT data in comparison with Ao-RCT and MDCT (r=0.91, r=0.76, respectively). The Bland-Altman analysis showed smaller differences in MDCT and LV-RCT annulus measurements than between MDCT and Ao-RCT (LV-RCT: mean=0.4 mm, limits of agreement -1.5-2.3 mm vs. Ao-RCT: mean=0.1 mm, limits of agreement -3.4-3.6 mm). The inter-observer agreement for the annulus measurements was significantly increased for LV-RCT as calculated by the intra-class coefficient (ICC=0.85) in comparison with Ao-RCT (ICC=0.52).nnnCONCLUSIONSnCardiac catheterisation including LV-RCT offers complementary assessment of left ventricular function, aortic valve anatomy, coronary angiography and arterial access routes. LV-RCT for aortic root measurements shows better correlation to MDCT than standard Ao-RCT protocols.

Deep sedation Vs. general anesthesia in 232 patients undergoing percutaneous mitral valve repair using the MitraClip® system

To investigate in a series of 232 patients whether the MitraClip® procedure can be performed safely using deep sedation (DS) without general anesthesia (GA).

severe aortic valve stenosis in the elderly: high prevalence of sleep-related breathing disorders

Background Aortic valve stenosis is common in the elderly, with a prevalence of nearly 3% in patients aged 75 years or older. Despite the fact that sleep-related breathing disorders (SRBD) are thought to be associated with cardiac disease, little is known about their prevalence in this patient cohort. The purpose of this study was to evaluate the prevalence of SRBD in older patients with aortic valve stenosis admitted for transcatheter aortic valve implantation. Methods Forty-eight consecutive patients (mean age 81±6 years; 37.5% male) with symptomatic aortic valve stenosis and considered for transcatheter aortic valve replacement were screened for SRBD. Sleep studies were performed by in-hospital unattended cardiorespiratory polygraphy measuring nasal air flow, chest and abdominal efforts, as well as oxygen saturation and body position. The patients were divided in subgroups dependent on the documented apnea–hypopnea index (AHI; no SRBD was defined as an AHI of <5 events/hour; mild SRBD as AHI 5–15 events/hour, and moderate to severe SRBD as AHI ≥15 events/hour). Results Thirty-seven patients (77%) had SRBD defined as an AHI of ≥5 events/hour. Eleven patients had an unremarkable investigation, with AHI <5 events/hour (mean 3.0±1.3 events/hour). Among patients with sleep apnea, 19 patients had mild SRBD, with an AHI of 5–15 events/hour (mean 9.9±3.4 events/hour) and 18 patients had moderate to severe SRBD (mean 26.6±11.3 events/hour). Mainly, obstructive apneas were found. Subgroups were not different regarding EuroSCORE (European System for Cardiac Operative Risk Evaluation) or aortic valve area. Also, no correlations were found between AHI and the additive or logistic EuroSCORE or aortic valve area. Significant correlations were found for AHI and N-terminal of the prohormone brain natriuretic peptide (r=0.53; P=0.003) and for AHI and glomerular filtration rate (r=−0.39; P=0.007). Conclusion SRBD is common in elderly patients with symptomatic aortic valve stenosis admitted for transcatheter aortic valve replacement. Interestingly, this finding is not reflected by the currently used risk scores. Further randomized studies are needed to evaluate the clinical significance of concomitant SRBD in the management of severe aortic stenosis.

Baseline HV-interval predicts complete AV-block secondary to transcatheter aortic valve implantation.

Purpose Development of AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). To date little is known about the predictive value of the HV-interval prior to TAVI with respect to the risk of AV- block development. Methods and results HV-interval was determined in 25 consecutive elderly patients with severe aortic valve stenosis (AS) before and immediately after TAVI. All patients subsequently underwent TAVI and 8 of these 25 patients (32%) developed complete AV-block during the TAVI procedure requiring permanent pacemaker implantation. Six of these 8 patients (75%) had marked HV prolongation (> 54 ms). Pre-procedural HV-interval was signifi cantly prolonged in the subgroup developing complete AV-block (62.1 ms ± 13.0 vs 49.2 ms ± 12.9; P = 0.029). Prolongation of the HV-interval above 54 ms was associated with a higher rate of complete AV-block (sensitivity 75.0%, specifi city 77.8%, P = 0.01). Conclusions HV-interval was prolonged in approximately one third of our elderly patients with aortic valve stenosis and associated with a high rate of complete AV-block following TAVI. HV-interval is easily obtained during TAVI screening procedures, thus facilitating identifi cation of patients at risk for complete AV-block due to TAVI and consequently enabling bespoke risk management.

High body mass index is a risk factor for difficult deep sedation in percutaneous mitral valve repair

Background The safety and efficacy of deep sedation (DS) in MitraClip® procedures have been shown previously. However, clinical experience demonstrates that in some patients DS is difficult to achieve. We hypothesize that some patient characteristics can predict difficult DS. Methods We prospectively analysed 69 patients undergoing MitraClip® procedures using DS. Application of DS was graded as simple (group 1) or difficult (group 2) depending on a cumulative score based on one point for each of the following criteria: decrease in oxygen saturation, retention of carbon dioxide, disruptive body movements, and the need for catecholamines. Patients with one point or less were classified as group 1, and patients with two or more points were classified as group 2. Results In 58 of 69 patients (84.1%), the performance of DS was simple, while in 11 patients (15.9%), DS was difficult to achieve. Patients with difficult DS were characterized by a higher body mass index (33.7 ± 6.0 kg/m2 vs. 26.1 ± 4.1; p = 0.001), younger age (67 ± 13 years vs. 75 ± 13 years; p = 0.044), and reduced left ventricular ejection fraction (36% ± 10 vs. 45% ± 14; p = 0.051) and presented more often with an obstructive sleep apnoea syndrome (6.9% vs. 45.5%; p = 0.003). In the multivariate analysis, body mass index was an independent predictor of difficult DS. Using a body mass index of 31 kg/m2 as a cut-off value, the sensitivity of predicting difficult DS was 73%, and the specificity was 88%. Using a body mass index of 35 kg/m2 as a cut-off value, the specificity increased to 97%, with a sensitivity of 36%. Conclusion In patients with a higher body mass index who undergo MitraClip® procedures, DS might be difficult to perform.

Red cell distribution width in anemic patients undergoing transcatheter aortic valve implantation

AIMnTo determine the impact of red blood cell distribution width on outcome in anemic patients undergoing transcatheter aortic valve implantation (TAVI).nnnMETHODSnIn a retrospective single center cohort study we determined the impact of baseline red cell distribution width (RDW) and anemia on outcome in 376 patients with aortic stenosis undergoing TAVI. All patients were discussed in the institutional heart team and declined for surgical aortic valve replacement due to high operative risk. Collected data included patient characteristics, imaging findings, periprocedural in hospital data, laboratory results and follow up data. Blood samples for hematology and biochemistry analysis were taken from every patient before and at fixed intervals up to 72 h after TAVI including blood count and creatinine. Descriptive statistics were used for patients characteristics. Kaplan-Meier survival curves were used for time to event outcomes. A recursive partitioning regression and classification was used to investigate the association between potential risk factors and outcome variables.nnnRESULTSnMean age in our study population was 81 ± 6.1 years. Anemia was prevalent in 63.6% (n = 239) of our patients. Age and creatinine were identified as risk factors for anemia. In our study population, anemia per se did influence 30-d mortality but did not predict longterm mortality. In contrast, a RDW > 14% showed to be highly predictable for a reduced short- and longterm survival in patients with aortic valve disease after TAVI procedure.nnnCONCLUSIONnAge and kidney function determine the degree of anemia. The anisocytosis of red blood cells in anemic patients supplements prognostic information in addition to that derived from the WHO-based definition of anemia.