Guideline-endorsed follow-up after percutaneous valve therapies-non-attendance of TAVI and MitraClip patients.

BACKGROUND: Percutaneous valve therapies (PVT) are performed on a large number of patients. With increasing procedural volume, the need for follow-up has also increased. Follow-up in the heart valve clinic is endorsed by recent guidelines but utilization is unknown, making resource allocation in the clinic difficult. Central follow-up in valve centers may not be feasible for all patients in the future. METHODS: In our center, follow-up for PVT patients is scheduled at 1 month and 12 months after the index procedure. Patients are reminded of their appointment by invitation letters or phone calls. We analyzed 150 consecutive patients who underwent transcutaneous aortic valve implantation (TAVI) and MitraClip implantation (n = 300) at our center. RESULTS: At 1 month, 72.7% of patients attended their follow-up, while at 12 months the rate dropped to 58%. Patients who underwent TAVI were older than the MitraClip patients (82.7 vs. 76.1 years) but had lower mean logEuroSCORE (22.6% vs. 25.9%). There was no significant difference in 1­year mortality between TAVI and MitraClip patients (20% vs. 17.3%). By contrast, the rate of missed follow-up visits was higher for TAVI compared to MitraClip patients (52% vs. 33.3%; p = 0.002). Female patients less frequently attended follow-up (p = 0.005), whereas age, EuroSCORE, NYHA class, ejection fraction, and health status (EQ-5DVAS) were not predictors of attendance in multivariable analysis. Although the result of the EQ-5D assessment was not associated with mortality or attendance, completing the questionnaire was associated with overall survival (p < 0.001). CONCLUSION: In our heart valve clinic, we observed a high percentage of missed follow-up appointments (42% at 12 months) despite a structured follow-up plan. Factors significantly associated with non-attendance in multivariable analysis were female gender and having a TAVI rather than MitraClip. Future follow-up concepts should take such findings into account, and decentralized approaches need to be explored.

Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study.

AIMS: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study. METHODS AND RESULTS: Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively. CONCLUSIONS: These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.

Association of transcatheter direct mitral annuloplasty with acute anatomic, haemodynamic, and clinical outcomes in severe mitral valve regurgitation.

AIMS: Several approaches for transcatheter mitral valve repair for functional mitral valve regurgitation are established. Interventional direct annuloplasty is a novel trans-venous, trans-septal approach. While feasibility was proven recently, knowledge on its influence on cardiac dimensions, pressures, biomarkers, and clinical outcomes is sparse. METHODS AND RESULTS: Patients consecutively treated with direct annuloplasty-only procedures between December 2015 and April 2018 were included in this monocentric analysis. Echocardiographic measurements, biomarker levels, clinical status [New York Heart Association (NYHA) class and 6 min walk test] were assessed at baseline, at discharge, and at a 30 day follow-up. Overall, 18 patients (in mean 77.0 ± 7.4 years, 44.4% women) with initially all high-grade mitral valve regurgitation (MR) were included in this study. Procedural success rate was high (94.4%) without severe complications. Direct annuloplasty resulted in MR-reduction (post-procedural-MR mild or no/trace: 72.2%) and the proportion of patients with severe dyspnoea (NYHA III/IV) was reduced (88.9% vs. 50%, P = 0.008). Clinical results were associated with a relevant diminution of left atrial volumes (-16.5%, P < 0.001) and cardiac pressures [left atrial pressure (-32.3%, P = 0.019) and systolic pulmonary arterial pressure (PAP, -15.8%, P = 0.025)]. Patients with lower baseline levels of PAP (P = 0.022) as well as elevated highly sensitive troponin (P = 0.034) were more likely to archive clinical benefit (improvement in NYHA class ≥1 grade) after 1 month, which could not be correlated with the grade of MR-reduction. CONCLUSIONS: Transcatheter mitral valve repair by direct annuloplasty results in a relevant reduction of intracardiac pressures, left atrial volumes, dyspnoea, and MR. Lower PAP and higher troponin values at baseline could be associated to dyspnoea reduction.

Feasibility of a MPR-based 3DTEE guidance protocol for transcatheter direct mitral valve annuloplasty.

OBJECTIVES: Several interventional approaches have been established for the treatment of severe mitral regurgitation (MR) in patients at elevated risk for surgery. Direct annuloplasty is a relatively novel option in transcatheter mitral valve repair dedicated to reverse pathology in specific subsets of MR. With regard to echocardiographic guidance, this procedure presents with higher efforts in comparison with edge-to-edge therapy to enable safe and exact positioning of the device's anchors; evidence on optimal peri-interventional imaging is sparse. We tested a specific 3D-echo-guidance protocol implementing single-beat multiplanar reconstruction (MPR) and evaluated its feasibility. METHODS: Overall, 16 patients consecutively treated with transcatheter direct annuloplasty for severe MR (87.5% functional/6.3% degenerative/6.3% mixed pathology) were entered in this monocentric analysis. Of these, two patients received a combined procedure including edge-to-edge repair. For all implantations, a 3D-echo-guidance protocol inheriting MPR was employed. RESULTS: Periprocedural device time decreased continuously (overall mean 140 ± 55.1 minutes, 213 ± 38 minutes in the first 4 vs 108 ± 33 minutes in the last 4 procedures, P = .018) using the MPR-based echo protocol, going along with reduced fluoroscopy times and doses. Technical success rate was high (93.8%) without any serious cardiac-related adverse events. MR could be relevantly improved. CONCLUSION: Echocardiographic guidance of transcatheter direct annuloplasty using a real time MPR-based protocol is feasible and safe. Optimized imaging might enable reduced implantation times and potentially increases safety.

Advanced Protocol for Three-Dimensional Transesophageal Echocardiography Guidance Implementing Real-Time Multiplanar Reconstruction for Transcatheter Mitral Valve Repair by Direct Annuloplasty.

Transcatheter direct annuloplasty has been introduced as a novel interventional treatment option for severe mitral valve regurgitation. Until now, only one direct annuloplasty device (Edwards Cardioband) has been commercially available, being implanted in more than 250 patients worldwide. Yet this procedure poses greater challenges regarding optimal fluoroscopic and echocardiographic guidance compared with edge-to-edge repair: correct localization and orientation of the anchors upon penetration into the fibrous mitral annulus tissue and the basal left ventricular myocardium are preconditions for an optimal result and essential to avoid damage of the neighboring structures (atrioventricular node, circumflex artery, coronary sinus). Real-time single-beat multiplanar reconstruction has become available as an additional imaging tool for three-dimensional transesophageal echocardiography in most recent echo machines. In this review, we introduce a three-dimensional transesophageal echocardiography-based imaging protocol implementing real-time multiplanar reconstruction for transcatheter direct annuloplasty procedures, which optimizes and also simplifies echocardiographic guidance during the implantation. The advanced echocardiographic protocol might also help to expedite implantation times and potentially increase the safety of the procedure. In this "how-to" article, we describe in detail this novel approach for optimized guidance and compare its advantages and challenges to "conventional" echocardiographic imaging for transcatheter mitral valve repair.

6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation.

BACKGROUND: Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. OBJECTIVES: The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study. METHODS: Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events. RESULTS: Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm2 vs. 0.4 cm2; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01). CONCLUSIONS: Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; NCT02981953).

Therapeutic implications of a combined diagnostic workup including endomyocardial biopsy in an all-comer population of patients with heart failure: a retrospective analysis.

BACKGROUND: Aetiology of heart failure (HF) often remains obscure. We therefore evaluated the usefulness of a combined diagnostic approach including cardiac magnetic resonance imaging (CMRI) and endomyocardial biopsy (EMB) to assess the cause of unexplained cardiomyopathy underlying HF. METHODS AND RESULTS: We retrospectively investigated 100 consecutive patients (36% women, mean age 53.6 ± 18.8 years) presenting with unexplained cardiomyopathy (HF with reduced ejection fraction or left ventricular hypertrophy; excluding ischaemic and valvular heart disease; left ventricular ejection fraction 31.6 ± 13.9%, Left ventricular end-diastolic pressure 18.2 ± 9.3 mmHg, heart rate 89 ± 26.6 b.p.m.; mean ± SEM) at the University Medical Center Mainz. We performed electrocardiography, echocardiography, CMRI, and cardiac catheterization with EMB analysed at a Food and Drug Administration-approved reference centre in 100%, 94%, 69%, and 100% of patients, respectively. On the basis of CMRI findings, electrocardiography, echocardiography, and medical history, the exact cause of cardiomyopathy remained uncertain in 37 of 69 cases (53.6%). In EMB, 25% of patients had viral replication, 23% had inflammation defined as lymphocytic infiltrations without active virus replication, 1% had giant cell myocarditis, and 1% had eosinophilic myocarditis. After diagnostic workup including EMB findings, the cause of cardiomyopathy remained unidentified in 14% of the cases, classified as idiopathic dilated cardiomyopathy or hypertrophic cardiomyopathy in 10% or 4%, respectively. EMB helped to discuss a causal treatment strategy of HF involving immunosuppression or antiviral treatment in 53% of patients, which was opted for in 12% of the patients. CONCLUSIONS: A comprehensive workup including imaging and EMB in an all-comer population of patients with HF may help physicians to improve diagnostics of unexplained cardiomyopathy in the majority of cases.

NOX2 amplifies acetaldehyde-mediated cardiomyocyte mitochondrial dysfunction in alcoholic cardiomyopathy.

Alcoholic cardiomyopathy (ACM) resulting from excess alcohol consumption is an important cause of heart failure (HF). Although it is assumed that the cardiotoxicity of the ethanol (EtOH)-metabolite acetaldehyde (ACA) is central for its development and progression, the exact mechanisms remain obscure. Murine cardiomyocytes (CMs) exposed to ACA or EtOH showed increased superoxide (O2(•-)) levels and decreased mitochondrial polarization, both being normalized by NADPH oxidase (NOX) inhibition. C57BL/6 mice and mice deficient for the ACA-degrading enzyme mitochondrial aldehyde dehydrogenase (ALDH-2(-/-)) were fed a 2% EtOH diet for 5 weeks creating an ACA-overload. 2% EtOH-fed ALDH-2(-/-) mice exhibited a decreased cardiac function, increased heart-to-body and lung-to-body weight ratios, increased cardiac levels of the lipid peroxidation product malondialdehyde (MDA) as well as increased NOX activity and NOX2/glycoprotein 91(phox) (NOX2/gp91(phox)) subunit expression compared to 2% EtOH-fed C57BL/6 mice. Echocardiography revealed that ALDH-2(-/-)/gp91(phox-/-) mice were protected from ACA-overload-induced HF after 5 weeks of 2% EtOH-diet, demonstrating that NOX2-derived O2(•-) contributes to the development of ACM. Translated to human pathophysiology, we found increased gp91(phox) expression in endomyocardial biopsies of ACM patients. In conclusion, ACM is promoted by ACA-driven mitochondrial dysfunction and can be improved by ablation of NOX2/gp91(phox). NOX2/gp91(phox) therefore might be a potential pharmacological target to treat ACM.

Feasibility and safety of left ventricular endomyocardial biopsy via transradial access: Technique and initial experience.

BACKGROUND: Endomyocardial biopsy constitutes an essential part of the diagnostic algorithm in patients with heart failure of unknown origin, but usually requires transfemoral access. METHODS AND RESULTS: Here, we describe a novel method that allows interventional cardiologists to obtain left ventricular biopsies via transradial access with a 7.5F sheathless multipurpose (MP1.0) guiding catheter. This approach was successfully conducted in 37 consecutive patients at our institution with only one intraprocedural minor complication (ventricular fibrillation during insertion of the guiding catheter). CONCLUSIONS: Transradial access to obtain left ventricular endomyocardial biopsies is a feasible and safe option for experienced radial operators.