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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.

Structural heart disease interventions have undergone an enormous development and many innovative approaches have become routinely performed procedures. Consequently, procedural standardization for the purpose of quality assurance is of increasing relevance. Interventional echocardiography plays a major role for the quality of structural heart procedures. At the same time, echocardiographic guiding can be extremely demanding for the echocardiographer and the understanding of the employed devices and procedural steps is an essential prerequisite. The present position paper summarizes these aspects with the goal of a standardized approach to interventional echocardiography. Its content will serve as the basis of future seminars by the German Cardiac Society. These courses will be mandatory to obtain the competence certificate for interventional echocardiography by the German Cardiac Society. Apart from the abovementioned aspects of quality assurance, the goal of the present initiative is to promote the perception of interventional echocardiography as a newly formed competence equivalent to the performance of interventional procedures.

The second manual on indications for and performance of echocardiography focusses on specific echocardiographic modalities and special problems in several patient cohorts. Practical aspects are discussed with priority. Established echocardiographic modalities are transesophageal, stress and contrast echocardiography. Modern technologies, such as 3D echocardiography and deformation imaging play an important role in nearly all scenarios of clinical echocardiography. This complete echocardiographic spectrum is incorporated into emergency and intensive care medicine, monitoring interventions of structural heart diseases, cardiac surgery, patients with cardiac assist devices, adult patients with congenital heart diseases and the care of highly infectious patients in pandemics. The diagnostic procedures of conventional and modern echocardiography are highlighted in this manual. The use of 3D echocardiography to characterize cardiac morphology and the application of deformation imaging to objectify cardiac function are already established in clinical practice. Stress echocardiography to detect myocardial ischemia and viability or to diagnose valvular heart diseases, assessment of coronary flow reserve to analyze myocardial perfusion and contrast echocardiography for left ventricular opacification and tumor characterization are increasingly being used to improve diagnostics. As mentioned for conventional echocardiography in the last manual of echocardiography in 2009, the modern features in echocardiography require standardized documentation and acquisition of certain images with optimized ultrasound settings, because conclusive and reproducible data analysis can only be performed if the image quality is sufficient.

Aims: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report oneand 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.

The second manual on indications for and performance of echocardiography focusses on specific echocardiographic modalities and special problems in several patient cohorts. Practical aspects are discussed with priority. Established echocardiographic modalities are transesophageal, stress and contrast echocardiography. Modern technologies, such as 3D echocardiography and deformation imaging play an important role in nearly all scenarios of clinical echocardiography. This complete echocardiographic spectrum is incorporated into emergency and intensive care medicine, monitoring interventions of structural heart diseases, cardiac surgery, patients with cardiac assist devices, adult patients with congenital heart diseases and the care of highly infectious patients in pandemics. The diagnostic procedures of conventional and modern echocardiography are highlighted in this manual. The use of 3D echocardiography to characterize cardiac morphology and the application of deformation imaging to objectify cardiac function are already established in clinical practice. Stress echocardiography to detect myocardial ischemia and viability or to diagnose valvular heart diseases, assessment of coronary flow reserve to analyze myocardial perfusion and contrast echocardiography for left ventricular opacification and tumor characterization are increasingly being used to improve diagnostics. As mentioned for conventional echocardiography in the last manual of echocardiography in 2009, the modern features in echocardiography require standardized documentation and acquisition of certain images with optimized ultrasound settings, because conclusive and reproducible data analysis can only be performed if the image quality is sufficient., Das zweite Manual zur Indikation und Durchführung der Echokardiographie bezieht sich auf spezifische Anwendungen der Echokardiographie und besondere Fragestellungen bei speziellen Patientengruppen. Dabei stehen v. a. praktische Aspekte im Vordergrund. Methodisch etabliert sind die transösophageale Echokardiographie, die Stressechokardiographie und die Kontrastechokardiographie. Bei nahezu allen echokardiographischen Untersuchungen spielen aktuell 3‑D-Echokardiographie und Deformationsbildgebung eine Rolle. Das gesamte Spektrum der echokardiographischen Möglichkeiten wird derzeit in Notfall- und Intensivmedizin, bei der Überwachung und Führung von Katheterinterventionen, bei strukturellen Herzerkrankungen, bei herzchirurgischen Operationen, bei der Nachsorge von kardialen Unterstützungssystemen, bei kongenitalen Vitien im Erwachsenenalter und bei der Versorgung von hochinfektiösen Patienten in Pandemiezeiten angewandt. Die diagnostischen Fortschritte der konventionellen und modernen echokardiographischen Anwendungen stehen im Fokus dieses Manuals. Die 3‑D-Echokardiographie zur Charakterisierung der kardialen Morphologie und die Deformationsbildgebung zur Objektivierung der kardialen Funktion sind bei vielen Indikationen im klinischen Alltag etabliert. Die Stressechokardiographie zur Ischämie‑, Vitalitäts- und Vitiendiagnostik, die Bestimmung der koronaren Flussreserve und die Kontrastechokardiographie bei der linksventrikulären Wandbewegungsanalyse und kardialen Tumordetektion finden zunehmend klinische Anwendung. Wie für die konventionelle Echokardiographie im ersten Manual der Echokardiographie 2009 beschrieben, erfordert der Einsatz moderner echokardiographischer Verfahren die standardisierte Dokumentation und Akquisition bestimmter Bildsequenzen bei optimierter Geräteeinstellung, da korrekte und reproduzierbare Auswertungen nur bei guter Bildqualität möglich sind., Title in Web of Science: Manual on indications and performance of specific echocardiographic applications

The second manual on indications for and performance of echocardiography focusses on specific echocardiographic modalities and special problems in several patient cohorts. Practical aspects are discussed with priority. Established echocardiographic modalities are transesophageal, stress and contrast echocardiography. Modern technologies, such as 3D echocardiography and deformation imaging play an important role in nearly all scenarios of clinical echocardiography. This complete echocardiographic spectrum is incorporated into emergency and intensive care medicine, monitoring interventions of structural heart diseases, cardiac surgery, patients with cardiac assist devices, adult patients with congenital heart diseases and the care of highly infectious patients in pandemics. The diagnostic procedures of conventional and modern echocardiography are highlighted in this manual. The use of 3D echocardiography to characterize cardiac morphology and the application of deformation imaging to objectify cardiac function are already established in clinical practice. Stress echocardiography to detect myocardial ischemia and viability or to diagnose valvular heart diseases, assessment of coronary flow reserve to analyze myocardial perfusion and contrast echocardiography for left ventricular opacification and tumor characterization are increasingly being used to improve diagnostics. As mentioned for conventional echocardiography in the last manual of echocardiography in 2009, the modern features in echocardiography require standardized documentation and acquisition of certain images with optimized ultrasound settings, because conclusive and reproducible data analysis can only be performed if the image quality is sufficient.

Aims: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report oneand 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.

OBJECTIVES The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI). BACKGROUND The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR. METHODS The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width >= 14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR <= 2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year. RESULTS Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly tower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio:1.91; 95% confidence interval:1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048). CONCLUSIONS Baseline massive or torrential TR is associated with an increased risk for all-caus

OBJECTIVES The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system. BACKGROUND The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture. METHODS Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE). RESULTS Among the 309 patients (mean age 77 +/- 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 +/- 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was <= 2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class <= II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%). CONCLUSIONS Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status. (C) 2020 by the American College of Cardiology Foundation.

The new manual on indications for and performance of echocardiography focuses primarily on the transthoracic echocardiographic approach. The performance of a standardized documentation in transthoracic echocardiography includes the acquisition of several cineloops and Doppler spectra with consecutive measurements illustrated by figures and a scheme of an echocardiographic report. The extended documentation in transthoracic echocardiography is presented with respect to specific pathological alterations of the heart. This includes alterations of the left ventricular wall thickness, the global and regional reduction of left ventricular function, diastolic dysfunction with normal left ventricular systolic function, pressure and volume overload of the right ventricle and the reduction of right ventricular function and pathological alterations of the heart valves. Echocardiography performed in the presence of aortic valve stenosis and regurgitation, mitral valve stenosis and regurgitation, tricuspid valve regurgitation as well as less common heart valve diseases and endocarditis is presented in special sections. The manual ends with sections describing additional echocardiographic modalities, the reporting and the use of emergency echocardiography.

OBJECTIVES The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI). BACKGROUND The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR. METHODS The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width >= 14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR <= 2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year. RESULTS Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly tower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio:1.91; 95% confidence interval:1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048). CONCLUSIONS Baseline massive or torrential TR is associated with an increased risk for all-caus

OBJECTIVES The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system. BACKGROUND The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture. METHODS Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE). RESULTS Among the 309 patients (mean age 77 +/- 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 +/- 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was <= 2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class <= II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%). CONCLUSIONS Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status. (C) 2020 by the American College of Cardiology Foundation.

Aims The Cardioband (TM) (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016. Methods and results Sixty patients with moderate or severe secondary MR (72 7 years, 60% ischaemic origin) on guideline recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year [but worsened by at least one grade in 11 patients (22%)]. Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (-19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MVVT) improved significantly (all P < 0.01). Conclusion In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-direct

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 cm(2) vs. 0.4 cm(2); 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 s

BACKGROUND Tricuspid regurgitation is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unknown. OBJECTIVES The purpose of this study was to investigate the potential benefit of TTVI over medical therapy in a propensity score matched population. METHODS The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers who underwent TTVI from 2016 to 2018. A control cohort formed by 2 large retrospective registries enrolling medically managed patients with >= moderate tricuspid regurgitation in Europe and North America (n = 1,179) were propensity score 1:1 matched (distance +/- 0.2 SD) using age, EuroSCORE II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite. RESULTS After matching, 268 adequately matched pairs of patients were identified. Compared with control subjects, TTVI patients had lower 1-year mortality (23 +/- 3% vs. 36 +/- 3%; p = 0.001), rehospitalization (26 +/- 3% vs. 47 +/- 3%; p < 0.0001), and composite endpoint (32 +/- 4% vs. 49 +/- 3%; p = 0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.79; p = 0.003 unadjusted), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR: 0.39; 95% CI: 0.26 to 0.59; p < 0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR: 0.35; 95% CI: 0.23 to 0.54; p < 0.0001). CONCLUSIONS In this propensity-matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these

Aims The Cardioband (TM) (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016. Methods and results Sixty patients with moderate or severe secondary MR (72 7 years, 60% ischaemic origin) on guideline recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year [but worsened by at least one grade in 11 patients (22%)]. Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (-19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MVVT) improved significantly (all P < 0.01). Conclusion In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-direct

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 cm(2) vs. 0.4 cm(2); 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 s

BACKGROUND Tricuspid regurgitation is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unknown. OBJECTIVES The purpose of this study was to investigate the potential benefit of TTVI over medical therapy in a propensity score matched population. METHODS The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers who underwent TTVI from 2016 to 2018. A control cohort formed by 2 large retrospective registries enrolling medically managed patients with >= moderate tricuspid regurgitation in Europe and North America (n = 1,179) were propensity score 1:1 matched (distance +/- 0.2 SD) using age, EuroSCORE II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite. RESULTS After matching, 268 adequately matched pairs of patients were identified. Compared with control subjects, TTVI patients had lower 1-year mortality (23 +/- 3% vs. 36 +/- 3%; p = 0.001), rehospitalization (26 +/- 3% vs. 47 +/- 3%; p < 0.0001), and composite endpoint (32 +/- 4% vs. 49 +/- 3%; p = 0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.79; p = 0.003 unadjusted), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR: 0.39; 95% CI: 0.26 to 0.59; p < 0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR: 0.35; 95% CI: 0.23 to 0.54; p < 0.0001). CONCLUSIONS In this propensity-matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these

Aims Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. Methods and results The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 +/- 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 +/- 4.8 to 29 +/- 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR <= 2+. Conclusions This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.

This study was performed to assess the acute intraprocedural effects of transcatheter direct mitral annuloplasty using the Cardioband device on 3-dimensional (3D) anatomy of the mitral annulus. Of 45 patients with functional mitral regurgitation (MR) enrolled in a single arm, multicenter, prospective trial, 22 had complete pre- and post-implant 3D transesophageal echocardiography (TEE) images stored in native data format that allowed off-line 3D reconstruction. Images with the highest volume rate and best image quality were selected for analysis. Multiple measurements of annular geometry were compared from baseline to post-implant using paired t tests with Bonferroni correction to account for multiple comparisons. The device was successfully implanted in all patients, and MR was reduced to moderate in 2 patients, mild in 17 patients, and trace in 3 patients after final device cinching. Compared with preprocedural TEE, postprocedural TEE showed statistically significantly reductions in annular circumference (137 +/- 15 vs 128 +/- 17 mm; p = 0.042), intercommissural distance (42.4 +/- 4.3 vs 38.6 +/- 4.4 mm; p = 0.029), anteroposterior distance (40.9 +/- 5.4 vs 37.0 +/- 5.7 mm; p = 0.025), and aortic-mitral angle (117 +/- 8 degrees vs 112 +/- 8 degrees; p = 0.032). This study demonstrates that transcatheter direct mitral annuloplasty with the Cardioband device results in acute remodeling of the mitral annulus with successful reduction of functional MR. (C) 2016 Elsevier Inc. All rights reserved.

OBJECTIVES This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment. BACKGROUND Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device. METHODS Thirty-one patients (71.8 +/- 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 +/- 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 +/- 11%) were prospectively enrolled. RESULTS Procedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 +/- 0.5 cm at baseline to 2.5 +/- 0.4 cm after 1 month and to 2.4 +/- 0.4 cm after 6 months, respectively (p<0.001). Percentage of patients with FMR >= 3 was reduced from 77.4% to 10.7% 1 month after the procedure (p < 0.001) and 13.6% (p < 0.001) at 7 months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% after 7 months (p<0.001); exercise capacity as assessed by 6-min walking test increased from 250 +/- 107 m to 332 +/- 118 m (p<0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (p < 0.001). CONCLUSIONS In this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with the Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms and demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554) (C) 2016 by the American College of Cardiology Foundation.

Aims Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. Methods and results The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 +/- 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 +/- 4.8 to 29 +/- 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR <= 2+. Conclusions This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.

This study was performed to assess the acute intraprocedural effects of transcatheter direct mitral annuloplasty using the Cardioband device on 3-dimensional (3D) anatomy of the mitral annulus. Of 45 patients with functional mitral regurgitation (MR) enrolled in a single arm, multicenter, prospective trial, 22 had complete pre- and post-implant 3D transesophageal echocardiography (TEE) images stored in native data format that allowed off-line 3D reconstruction. Images with the highest volume rate and best image quality were selected for analysis. Multiple measurements of annular geometry were compared from baseline to post-implant using paired t tests with Bonferroni correction to account for multiple comparisons. The device was successfully implanted in all patients, and MR was reduced to moderate in 2 patients, mild in 17 patients, and trace in 3 patients after final device cinching. Compared with preprocedural TEE, postprocedural TEE showed statistically significantly reductions in annular circumference (137 +/- 15 vs 128 +/- 17 mm; p = 0.042), intercommissural distance (42.4 +/- 4.3 vs 38.6 +/- 4.4 mm; p = 0.029), anteroposterior distance (40.9 +/- 5.4 vs 37.0 +/- 5.7 mm; p = 0.025), and aortic-mitral angle (117 +/- 8 degrees vs 112 +/- 8 degrees; p = 0.032). This study demonstrates that transcatheter direct mitral annuloplasty with the Cardioband device results in acute remodeling of the mitral annulus with successful reduction of functional MR. (C) 2016 Elsevier Inc. All rights reserved.

OBJECTIVES This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment. BACKGROUND Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device. METHODS Thirty-one patients (71.8 +/- 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 +/- 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 +/- 11%) were prospectively enrolled. RESULTS Procedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 +/- 0.5 cm at baseline to 2.5 +/- 0.4 cm after 1 month and to 2.4 +/- 0.4 cm after 6 months, respectively (p<0.001). Percentage of patients with FMR >= 3 was reduced from 77.4% to 10.7% 1 month after the procedure (p < 0.001) and 13.6% (p < 0.001) at 7 months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% after 7 months (p<0.001); exercise capacity as assessed by 6-min walking test increased from 250 +/- 107 m to 332 +/- 118 m (p<0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (p < 0.001). CONCLUSIONS In this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with the Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms and demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554) (C) 2016 by the American College of Cardiology Foundation.