Multimodality imaging for intraprocedural guidance of a transcatheter tricuspid valve replacement.

Intraprocedural multimodality imaging, combining TEE with CT-fluoro fusion and ICE, can promote TTVR procedural success by improved guidance of critical steps of the device implantation.

Arrythmia-Mediated Valvular Heart Disease.

The aging population is rising at record pace worldwide. Along with it, a steep increase in the prevalence of atrial fibrillation and heart failure with preserved ejection fraction is to be expected. Similarly, both atrial functional mitral and tricuspid regurgitation (AFMR and AFTR) are increasingly observed in daily clinical practice. This article summarizes all current evidence regarding the epidemiology, prognosis, pathophysiology, and therapeutic options. Specific attention is addressed to discern AFMR and AFTR from their ventricular counterparts, given their different pathophysiology and therapeutic needs.

Survival benefit of overweight patients undergoing MitraClip® procedure in comparison to normal-weight patients.

BACKGROUND: The number of MitraClip® implantations increased significantly in recent years. Data regarding the impact of weight class on survival are sparse. HYPOTHESIS: We hypothesized that weight class influences survival of patients treated with MitraClip® implantation. METHODS: We investigated in-hospital, 1-year, 3-year, and long-term survival of patients successfully treated with isolated MitraClip® implantation for mitral valve regurgitation (MR) (June 2010-March 2018). Patients were categorized by weight classes, and the impact of weight classes on survival was analyzed. RESULTS: Of 617 patients (aged 79.2 years; 47.3% females) treated with MitraClip® implantation (June 2010-March 2018), 12 patients were underweight (2.2%), 220 normal weight (40.1%), 237 overweight (43.2%), and 64 obesity class I (11.7%), 12 class II (2.2%), and 4 class III (0.7%). Preprocedural Logistic EuroScore (21.1 points [IQR 14.0-37.1]; 26.0 [18.5-38.5]; 26.0 [18.4-39.9]; 24.8 [16.8-33.8]; 33.0 [25.9-49.2]; 31.6 [13.1-47.6]; p = .291) was comparable between groups. Weight class had no impact on in-hospital death (0.0%; 4.1%; 1.5%; 0.0%; 7.7%; 0.0%; p = .189), 1-year survival (75.0%; 72.0%; 76.9%; 75.0%; 75.0%; 33.3%; p = .542), and 3-year survival (40.0%; 36.8%; 38.2%; 48.6%; 20.0%; 33.3%; p = .661). Compared to normal weight, underweight (hazard ratio [HR]: 1.35 [95% confidence interval [CI]: 0.65-2.79], p = .419), obesity-class I (HR: 0.93 [95% CI: 0.65-1.34], p = .705), class II (HR: 0.39 [95% CI: 0.12-1.24], p = .112), and class III (HR: 1.28 [95% CI: 0.32-5.21], p = .726) did not affect long-term survival. In contrast, overweight was associated with better survival (HR: 1.32 [95% CI: 1.04-1.68], p = .023). CONCLUSION: Overweight affected the long-term survival of patients undergoing MitraClip® implantation beneficially compared to normal weight.

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience.

AIMS: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. METHOD AND RESULTS: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p = 0.41). CONCLUSION: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Treating symptoms and reversing remodelling: clinical and echocardiographic 1-year outcomes with percutaneous mitral annuloplasty for mild to moderate secondary mitral regurgitation.

AIMS: To determine the effects of percutaneous mitral annuloplasty on symptoms, walk distance and left ventricular (LV) structure and function in patients with mild or moderate secondary mitral regurgitation (SMR). METHODS AND RESULTS: This was a pooled analysis of patients (n = 68) who, despite guideline-directed medical therapy had symptomatic heart failure (HF) with mild (n = 25) or moderate (n = 43) SMR treated with percutaneous mitral annuloplasty as part of the TITAN, TITAN II, or REDUCE-FMR trials. Primary outcomes were changes in symptoms, 6-min walk distance, and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) after 1 year. Secondary analyses included changes in LV structure and function. At 1 year, New York Heart Association class status was maintained (48%) or improved (46%) in most patients, mean KCCQ scores increased from baseline by 10 units [95% confidence interval (CI) 3 to17; P < 0.01] and mean 6-min walk test distance increased by 34 m (95% CI 12 to 57; P < 0.01). SMR grade improved in 25% of patients and was maintained in 58% of patients with changes in mean regurgitant volume of -7 mL (95% CI -11 to -3; P < 0.001), vena contracta -0.11 cm (95% CI -0.20 to -0.02; P < 0.05), and effective regurgitant orifice area -0.03 cm2 (95% CI -0.06 to -0.01; P < 0.05). There were non-significant improvements in LV ejection fraction and volumes. Survival over 1 year was 89% with no difference between mild (96%) and moderate (86%) SMR (log-rank P = 0.22). Progression-free survival was 70% (82% in mild vs. 63% in moderate SMR; P = 0.16). Freedom from HF hospitalization was 73% (87% in mild SMR vs. 66% in moderate SMR; P = 0.07). CONCLUSION: Among patients with symptomatic HF and mild or moderate SMR on guideline-directed medical therapy, percutaneous mitral annuloplasty was associated with improvements in symptoms, SMR, a stabilization of LV structure and function, and high survival rates.

Cardiopulmonary Hemodynamic Profile Predicts Mortality After Transcatheter Tricuspid Valve Repair in Chronic Heart Failure.

OBJECTIVES: This study was designed to assess hemodynamic changes in response to transcatheter tricuspid valve edge-to-edge repair (TTVR) and to identify hemodynamic predictors associated with mortality. BACKGROUND: Severe tricuspid regurgitation (TR) is associated with high mortality. TTVR effectively alleviates heart failure symptoms, but comprehensive hemodynamic characterization of patients undergoing TTVR is currently lacking. METHODS: This international, multicenter study included 236 patients undergoing TTVR. Data from clinical assessment, echocardiography, intraprocedural right heart catheterization, and noninvasive cardiac output measurement were analyzed. Hemodynamic predictors for mortality were identified using linear Cox regression analysis and were used for stratification of patients with subsequent analysis of survival time. RESULTS: Patients (median age 78 years, 53% women) were symptomatic (89% in New York Heart Association functional class III or IV) because of severe TR (grade ≥3+ in 100%). TTVR significantly reduced TR at discharge (grade ≥3+ in 16%; p < 0.001), with a corresponding 19% reduction of the right atrial v wave (21 mm Hg vs. 16 mm Hg; p < 0.001) and an improvement in cardiac output (from 3.5 to 4.0 l/min; p < 0.01). Invasive mean pulmonary artery pressure, transpulmonary gradient, pulmonary vascular resistance, and right ventricular stroke work were significant predictors of 1-year mortality (p < 0.05 for all). Hemodynamic stratification by mean pulmonary artery pressure and transpulmonary gradient best predicted 1-year survival (p < 0.001). Although patients with pre-capillary dominant pulmonary hypertension showed an unfavorable prognosis (1-year survival 38%), patients without or with post-capillary pulmonary hypertension had favorable outcome (1-year survival 92% or 78%, respectively). CONCLUSIONS: Invasive assessment of cardiopulmonary hemodynamic status predicts survival after TTVR. Invasive hemodynamic characterization may help identify patients profiting most from TTVR.

Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?

OBJECTIVES: To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry. BACKGROUND: The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse. METHODS: In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year. RESULTS: Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02). CONCLUSIONS: TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.

5-Year Experience of In-Hospital Outcomes After Percutaneous Left Atrial Appendage Closure in Germany.

OBJECTIVES: The aim of this study was to evaluate 5-year in-hospital trends and safety outcomes of left atrial appendage (LAA) closure in the German nationwide inpatient sample. BACKGROUND: The safety and efficacy of percutaneous LAA closure have been demonstrated in randomized trials and prospective cohort studies, but results from large samples are missing. METHODS: Data on patient characteristics and in-hospital safety outcomes for all percutaneous LAA closures performed in Germany between 2011 and 2015 were analyzed. Overall, 15,895 inpatients were included. RESULTS: The annual number of LAA occlusions increased from 1,347 in 2011 to 4,932 in 2015 (ß = 1.00; 95% confidence interval [CI]: 0.95 to 1.01; p < 0.001), with a nonsignificant uptrend of in-hospital mortality (from 0.5% in 2011 to 0.9% in 2015; ß = 0.01; 95% CI: -0.09 to 0.32; p = 0.271). Patient characteristics shifted toward older age and higher prevalence of comorbidities such as heart failure, chronic obstructive pulmonary disease, and chronic renal insufficiency over time. Important independent predictors of in-hospital mortality were cancer (odds ratio [OR]: 2.49; 95% CI: 1.00 to 6.12; p = 0.050), heart failure (OR: 2.42; 95% CI: 1.72 to 3.41; p < 0.001), stroke (OR: 5.39; 95% CI: 2.76 to 10.53; p < 0.001), acute renal failure (OR: 13.28; 95% CI: 9.08 to 19.42; p < 0.001), pericardial effusion (OR: 5.65; 95% CI: 3.76 to 8.48; p < 0.001), and shock (OR: 45.11; 95% CI: 31.01 to 65.58; p < 0.001). CONCLUSIONS: The use of percutaneous LAA closure increased 3.6-fold from 2011 to 2015, with a nonsignificant uptrend of in-hospital mortality rate in this real-world setting. Important predictors of in-hospital death were acute renal failure, pericardial effusion, and ischemic stroke during hospitalization.

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).

Safety and efficacy of MitraClip™ therapy in patients with severely impaired left ventricular ejection fraction: results from the German transcatheter mitral valve interventions (TRAMI) registry.

AIMS: The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function. METHODS AND RESULTS: Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failure patients. CONCLUSION: In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function.

Effects of atrial fibrillation and heart rate on percutaneous mitral valve repair with MitraClip: results from the TRAnscatheter Mitral valve Interventions (TRAMI) registry.

AIMS: In patients undergoing percutaneous edge-to-edge mitral valve repair for mitral valve regurgitation (MR), our aim was to evaluate acute and follow-up differences with pre-existing sinus rhythm (SR) or atrial fibrillation (AF), as well as comparisons stratified by baseline heart rate. METHODS AND RESULTS: Seven hundred and sixty patients who underwent a MitraClip procedure were prospectively enrolled in the TRAnscatheter Mitral valve Interventions (TRAMI) registry, and stratified according to baseline heart rhythm and heart rate with a cut-off value of 70 beats per minute. Technical success, procedural characteristics and MR reduction were similar throughout the subgroups. Overall, in-hospital adverse event rates were low in this high-risk patient collective. At 12 months, survival was higher in SR (83.5%) than AF patients (74.9%, p<0.05), while the cumulative major adverse cardio-cerebrovascular event rate did not differ, and a sustained improvement of NYHA functional class occurred in all subgroups. CONCLUSIONS: These registry data, comprising the largest number of unselected "real-world" MitraClip patients, suggest that the intervention can be performed safely and effectively, and reduces MR in the majority of patients irrespective of baseline rhythm or heart rate. While 12-month survival was higher for patients with SR, overall MACCE and clinical improvement did not differ between the subgroups.

Temporal Trends in the Prevalence of Infective Endocarditis in Germany Between 2005 and 2014.

Infective endocarditis (IE) is a potentially life-threatening disease. Little is known about temporal trends in its prevalence in Germany. In 2009, recommendations for antibiotic prophylaxis were deescalated in the revised European Society of Cardiology guideline to include only patients at high risk of IE. We selected patients with the discharge diagnosis of IE based on the International Classification of Diseases code I33 in the nationwide database of the Federal Statistical Office of Germany. We identified 94,364 patients with a diagnosis of IE from January 2005 to December 2014. Mean prevalence was 11.6 per 100,000 citizens per year in this 10-year-period. The annual IE prevalence showed a continuous small increase from 2006 to 2010 (9.5 to 10.6 IE diagnoses per 100,000 citizens) and a larger increase from 2011 to 2014 (11.1 to 14.4 IE diagnoses per 100,000 citizens; linear regression: ß 2.9, 95% confidence interval 1.1 to 4.6; p = 0.006). The prevalence of IE in Germany was lower compared to the United States but higher compared to England. Overall, 15,995 patients (17%) died in hospital. Case fatality rate after a diagnosis of IE remained largely constant from 2005 to 2014. In conclusion, the annual prevalence of IE continuously increased during the observed period with more pronounced trend after the revised 2009 European Society of Cardiology guideline.

Inflammation in right ventricular dysfunction due to thromboembolic pulmonary hypertension.

OBJECTIVES AND BACKGROUND: Activation of the immune system is well established in patients with chronic heart failure (CHF) and impaired left ventricular function. High levels of pro-inflammatory cytokines are associated with a poor prognosis. Chronic thromboembolic pulmonary hypertension (CTEPH) frequently leads to impaired right ventricular function. It is not known whether such patients display chronic immune activation as well. METHODS AND RESULTS: We studied 49 patients with CTEPH (50±2 years, right ventricular ejection fraction [RVEF] 29±2%, left ventricular ejection fraction [LVEF] 51±3%, mean±SEM) and compared their results with 17 patients with CHF (71±2 years, LVEF 23±1%) and 34 age-matched control subjects (age 57±2 years). We studied serum levels of tumor necrosis factor-α (TNFα), its soluble receptors 1 and 2 (sTNFR1 and 2), interleukin-10 (IL-10) and plasma N-terminal-pro-B-type natriuretic peptide (NT-proBNP). Serum TNFα was not different in CTEPH compared with CHF patients (p=0.67) but both their levels were significantly higher than in controls (both p<0.001). Similar results were obtained for sTNFR1, sTNFR2, and IL-10. Levels of NT-proBNP were not different in patients with CTEPH or CHF (p=0.54), but significantly higher than in control subjects (both p<0.001). There were significant correlations between RVEF as assessed by magnetic resonance imaging and sTNFR1, sTNFR2, IL-6, high sensitivity C-reactive protein, and NT-proBNP (all p<0.05) in patients with CTEPH. CONCLUSION: Similar levels of immune activation as reflected by high levels of pro-inflammatory cytokines are present in patients with isolated right ventricular dysfunction due to CTEPH and patients with CHF and left ventricular dysfunction.