Transgastric imaging-The key to successful periprocedural TEE guiding for edge-to-edge repair of the tricuspid valve.

Intraprocedural transesophageal echocardiography (TEE) guidance plays an essential role in transcatheter repair therapy of the tricuspid valve (TV). So far, several different imaging concepts are in use. We propose an imaging protocol that fully addresses the morphological complexity of the TV and further offers efficacious workarounds for the frequently occurring restrictions of TV imaging in edge-to-edge repair of the TV. As a tertiary referral center with a large experience of more than 250 cases of transcatheter edge-to-edge repair (TEER) of the TV performed at the Heart Valve Center in Mainz/Germany, we have constantly adapted our peri-interventional echocardiographic approach to accomplish both. As a key measure for success, we intensely rely on the transgastric acoustic windows that not only deliver high-resolution information on the morphology of the TV and all relevant procedural steps but also help to avoid the frequent shadowing artifacts experienced in transesophageal imaging.

Reverse cardiac remodeling in patients undergoing combination therapy of transcatheter mitral valve repair.

Aims: For patients with severe mitral valve regurgitation (MR), different kinds of transcatheter mitral valve repair (TMVr) exist, targeting the leaflets, annulus, and chordae. The concomitant combination (COMBO) therapy of TMVrs is rarely used as treatment, and there are very few publications about this therapeutic strategy. We evaluated the effect of COMBO-TMVr on the cardiac left chambers and clinical data, including survival. Methods: We included 35 patients at high risk who underwent concomitant sequential transcatheter mitral valve edge-to-edge repair (M-TEER) and another TMVr for severe MR in our hospital between March 2015 and April 2018. Of these, 13 had adequate follow-up transthoracic echocardiography (TTE) up to around 1 year after the procedure. Results: Survival for all patients was 83% at 1 year, 71% at 2 years, and 63% at 3 years, respectively. In the 13 patients with adequate TTE follow-up, M-TEER plus either Cardioband (n = 4), Carillon Mitral Contour System (n = 7), or Neochord (n = 2) were used, respectively. Ten patients had secondary, and three patients primary MR. After 1 year, changes [median (Q1, Q3)] of left ventricular (LV) end-systolic diameter of -9.9 cm (-11.1, 0.4), LV end-diastolic diameter of -3.3 cm (-8.5, 0.0), LV end-systolic volume (LVESV) of -17.4 mL (-32.6, -0.4), LV end-diastolic volume (LVEDV) of -13.5 mL (-15.9, -3.2), LV mass of -19.5 g (-24.2, -7.6), and left atrial volume (LAV) index (LAVi) of -16.4 mL (-23.3, -11.3) were observed. A significant reduction was also seen in the change ratios of LVESV, LVEDV, LV mass, and LAVi, respectively. Conclusion: We found that COMBO therapy of TMVr seems feasible and may support reverse remodeling of left cardiac chambers during 1 year after the procedure in a cohort of patients at high risk.

Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial.

BACKGROUND: Tricuspid regurgitation (TR) is a common and progressive valve disease with significant mortality and hospitalization burden. Tricuspid transcatheter edge-to-edge repair provides a treatment option for high-risk patients with primary and secondary TR. METHODS: The TRILUMINATE trial ([Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation]; n=85) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of tricuspid transcatheter edge-to-edge repair with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessment was performed at a core laboratory. Outcomes included safety and clinical effectiveness and echocardiographic assessment of TR. RESULTS: At 2 years, TR was reduced to moderate or less in 60% of subjects, and reduction of at least 1 grade was achieved in 85.4% of subjects. TR reduction was sustained in 75% of the patients. While most metrics suggest the majority of favorable remodeling occurred within the first 30 days post-procedure, both right ventricular end diastolic diameter and tricuspid annular plane systolic excursion show signals of continued favorable remodeling through 2 years. Substantial improvements in 6-minute walking distance, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire score were sustained from 30 days to 2 years. Even with low rates of cardiovascular mortality (15.3%) and all-cause mortality (18.7%) noted at 2 years, all-cause hospitalization rate decreased from 1.30 events per patient-year 1 year before device implantation to 0.66 events per patient-year 2 years after the TriClip procedure, representing a reduction of 49% (P<0.0001). CONCLUSIONS: Tricuspid transcatheter edge-to-edge repair using the TriClip implant was found to be safe and effective, with sustained benefits at 2 years in subjects with symptomatic moderate or greater TR. Repair efficacy was durable at 2 years in 75% of the patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03227757.

Beware of the commissure - transcatheter aortic valve replacement in a rare anomaly of the left main coronary.

Anomalies of the coronary ostia are a potential challenge to the interventionalist. Commissural alignment has recently been introduced as concept for transcatheter aortic valve replacement (TAVR) to avoid potential coronary obstruction and to facilitate future coronary re-access. Here, we report a case of TAVR in a patient with a rare anomaly of the left coronary artery (LCA)-ostium, originating from the commissure between left- and noncoronary sinus, illustrating a potential pitfall for contemporary TAVR-implantation protocols and discuss the final choice of prosthesis suiting the demands of this distinct anatomical variance.

Right ventricular dysfunction predicts outcome after transcatheter mitral valve repair for primary mitral valve regurgitation.

AIMS: Right ventricular dysfunction (RVD), as expressed by right ventricular to pulmonary artery coupling, has recently been identified as a strong outcome predictor in patients undergoing mitral valve edge-to-edge repair (M-TEER) for secondary mitral regurgitation (MR). The aim of this study was to define RVD in patients undergoing M-TEER for primary MR (PMR) and to evaluate its impact on procedural MR reduction, symptomatic development and 2-year all-cause mortality. METHODS AND RESULTS: This multicentre study included patients undergoing M-TEER for symptomatic PMR at nine international centres. The study cohort was divided into a derivation (DC) and validation cohort (VC) for calculation and validation of the best discriminatory value for RVD. A total of 648 PMR patients were included in the study. DC and VC were comparable regarding procedural success and outcomes at follow-up. Sensitivity analysis identified RVD as an independent predictor for 2-year mortality in the DC (hazard ratio [HR] 2.37, 95% confidence interval [CI] 1.47-3.81, p < 0.001), which was confirmed in the VC (HR 2.06, 95% CI 1.36-3.13, p < 0.001). Procedural success (MR ≤2+) and symptomatic improvement at follow-up (New York Heart Association [NYHA] class ≤II) were lower in PMR patients with RVD (MR ≤2+: 82% vs. 93%, p = 0.002; NYHA class ≤II: 57.3% vs. 66.5%, p = 0.09 for with vs. without RVD). In all PMR patients, the presence of RVD significantly impaired 2-year survival after M-TEER (HR 2.23, 95% CI 1.63-3.05, p < 0.001). CONCLUSIONS: Mitral valve edge-to-edge repair is an effective treatment option for PMR patients. The presence of RVD is associated with less MR reduction, less symptomatic improvement and increased 2-year mortality. Accordingly, RVD might be included into pre-procedural prognostic considerations.

Minimizing Paravalvular Regurgitation With the Novel SAPIEN 3 Ultra TAVR Prosthesis: A Real-World Comparison Study.

Objectives: We investigated performance and outcome of the latest-generation balloon-expandable SAPIEN 3 Ultra prosthesis (S3U) compared to the established SAPIEN 3 prosthesis (S3) in a real-world cohort, with focus on paravalvular regurgitation (PVR). Background: PVR is an adverse prognostic indicator of short- and long-term survival after transcatheter aortic valve replacement (TAVR). The S3U has been designed to improve sealing. Methods: We enrolled 343 consecutive patients presenting with severe native aortic valve stenosis eligible for a balloon-expandable prosthesis. The established S3 was implanted in the first 200 patients, the following 143 patients received the novel S3U after introduction in our institution. Primary endpoint was PVR after TAVR. Furthermore, we investigated procedural parameters and in-hospital and 30-day outcome. Results: PVR was significantly lower in the S3U cohort compared to the S3 cohort. They differed in their rate of mild PVR (11.2 vs. 48.0%, p < 0.001), whereas at least moderate PVR was similarly low in both cohorts (0.7 vs. 0.5%, p = 0.811). A significant reduction of post-dilatation rate, fluoroscopy time, and amount of contrast was observed in patients treated with the novel S3U (p < 0.001). The rate of adverse events in the in-hospital course and at 30 days were similarly low. At 30 days more patients receiving S3U improved in NYHA class (improvement ≥2 grades 34.6 vs. 19.9%, p = 0.003). Conclusion: The current study provides evidence that the novel S3U strongly minimizes PVR, thereby demonstrating the efficacy of improved sealing. Further studies will have to address if the observed reduction of PVR with S3U has prognostic significance.

Early symptomatic benefit indicates long-term prognosis after transcatheter mitral valve edge-to-edge repair in functional and degenerative etiology.

BACKGROUND: Mitral regurgitation (MR) is common in patients with heart failure and constitutes an independent risk factor for adverse prognosis besides NYHA-class. The predictive value of dyspnea reduction after transcatheter mitral valve repair (TMVr) on outcome has not been investigated up to now. METHODS AND RESULTS: We enrolled 627 consecutive patients (47.0% female, 57.4% functional MR; median follow-up 486 days[IQR 157/961]; survival status available in 96.8%; symptoms assessed in n = 556 at baseline / n = 406 at 1 month) treated with isolated percutaneous mitral valve edge-to-edge repair in our center from 06/2010-03/2018 (exclusion of combined forms of TMVr) in a monocentric retrospective analysis. Survival was 97.6% at discharge, 73.9% after 1, 54.5% after 3, 37.6% after 5 and 21.7% after 7-years. Before TMVr, NYHA-classes III/IV were found in 89.0%. Of these, 74.7% reported symptomatic relief (reduction in NYHA-class) one month after procedure (NYHA class recorded in 406 patients at 30 days). NYHA-classes III/IV were documented in 37.2% (p < 0.001) at 30 days and in 36.6% (p < 0.001) at 1 year without significant changes between the follow-ups. Dyspnea reduction was accompanied by significantly improved long-term survival (1 year, 89.1 vs 71.2%, p = 0.001, 2 years: 75.5 vs 58.7%, p = 0.039) and was identified as an independent predictor for lower mortality (1-year HR for increased mortality by missing symptomatic improvement 2.94 [95%CI 1.53-5.65], p = 0.001; long-term HR 1.95 [95%CI 1.29-2.94], p = 0.001) independently in both etiologies of MR. CONCLUSION: TMVr by edge-to-edge therapy enables early and sustainable symptomatic improvement in nearly 75% of the symptomatic patients. The simple assessment of postinterventional changes in NYHA-class might serve as an independent predictor for mid- and long-term prognosis in both FMR and DMR.

Impact of Mitral Annular Dilation on Edge-to-Edge Therapy With MitraClip-XTR.

[Figure: see text].

Reversibility of severe mitral valve regurgitation after left ventricular assist device implantation: single-centre observations from a real-life population of patients.

OBJECTIVES: This study evaluates the impact of untreated preoperative severe mitral valve regurgitation (MR) on outcomes after left ventricular assist device (LVAD) implantation. METHODS: Of the 234 patients who received LVAD therapy in our centre during a 6-year period, we selected those who had echocardiographic images of good quality and excluded those who underwent mitral valve replacement prior to or mitral valve repair during LVAD placement. The 128 patients selected were divided into 2 groups: Group A with severe MR (n = 65) and Group B with none to moderate MR (n = 63, 28 with moderate MR). We evaluated transthoracic echocardiography preoperatively [15 (7-28) days before LVAD implantation; median (interquartile range)] and postoperatively up to the last available follow-up [501 (283-848) days after LVAD]. We collected mortality, complications and clinical status indicators of the patient cohort. RESULTS: We observed a significant decrease in the severity of MR after LVAD implantation (severe MR 51% pre- vs 6% post-LVAD implantation, P < 0.001). There was no difference between groups in terms of right heart failure, rate of urgent heart transplantation, pump thrombosis or ventricular arrhythmias. There was no difference in 1-year survival and 3-year survival (87.7% vs 88.4% and 71.8% vs 66.6% for Groups A and B, respectively, P = 0.97). CONCLUSIONS: Preoperative severe MR resolves in the majority of patients early on after LVAD implantation and is not associated with worse clinical outcomes or intermediate-term survival.

Influence of aortic valve opening in patients with aortic insufficiency after left ventricular assist device implantation.

OBJECTIVES: Aortic valve insufficiency (AI) following left ventricular assist device (LVAD) implantation can potentially limit the success of mechanical circulatory support. We examined the prevalence of significant AI in the new generation of LVADs and analysed the role of aortic valve opening in the development of AI in these patients. METHODS: Currently, 102 patients that received a continuous flow LVAD (cf-LVAD) between July 2009 and December 2013 are being treated in our outpatient clinic with an HeartWare ventricular assist device (HVDA) (n = 77) or HeartMate II (HMII, n = 25) and were included and analysed in a retrospective study. The mean age of the 12 female and 90 male patients was 54 ± 12 years. Ischaemic cardiomyopathy was diagnosed in 40% of patients. Echocardiographic measurements were reviewed before and after implantation. AI was considered significant if it was more than mild. RESULTS: Mean LVAD support duration was 572 ± 437 days. Significant AI was found in 32 patients (31.4%). De novo AI occurred in mean after 183 ± 246 days of support. One patient presented severe AI and received an aortic valve replacement. A permanently closed aortic valve correlates with a greater prevalence of AI when compared with intermittent or complete opening of aortic valve (P = 0.004). Aetiology of the cardiomyopathy and the type of device had no influence on the development of AI. Smaller left ventricle end-diastolic diameter and lower body surface area were significantly associated with the development of aortic insufficiency in our cohort. CONCLUSION: Aortic insufficiency has a high prevalence following assist device continuous flow support. Echocardiographic parameters are an integral part of ambulatory care of these patients and can guide the optimal setting for LVAD. An aortic valve that does not open should be avoided in order to prevent AI. Patients with HMII or HVAD did not show any differences terms of the prevalence of aortic insufficiency prevalence.

Barlow's Mitral Valve Disease: A Comparison of Neochordal (Loop) and Edge-To-Edge (Alfieri) Minimally Invasive Repair Techniques.

BACKGROUND: Barlow's mitral valve (MV) disease remains a surgical challenge. We compared short- and medium-term outcomes of neochordal ("loop") versus edge-to-edge ("Alfieri") minimally invasive MV repair in patients with Barlow's disease. METHODS: From January 2009 to April 2014, 123 consecutive patients with Barlow's disease (defined as bileaflet billowing or prolapse [or both], excessive leaflet tissue, and annular dilatation with or without calcification) underwent minimally invasive MV operations for severe mitral regurgitation (MR) at our institution. Three patients (2.4%) underwent MV replacement during the study period and were excluded from subsequent analysis. The loop MV repair technique was used in 68 patients (55.3%) and an edge-to-edge repair was performed in 44 patients (35.8%). Patients who underwent a combination of these 2 techniques (n = 8 [6.5%]) were excluded. The median age was 48 years, and 62.5% of patients were men. Concomitant procedures included closure of a patent foramen ovale or atrial septal defect (n = 19), tricuspid valve repair (n = 5), and atrial fibrillation ablation (n = 15). Follow-up was performed 24.7 ± 17 months postoperatively and was 98% complete. RESULTS: No deaths occurred perioperatively or during follow-up. Aortic cross-clamp time (64.1 ± 17.6 minutes versus 95.9 ± 29.5 minutes) and cardiopulmonary bypass (CPB) time (110.0 ± 24.2 minutes versus 146.4 ± 39.1 minutes) were significantly shorter (p < 0.001) in patients who received edge-to-edge repair. Although patients who underwent edge-to-edge repair received a larger annuloplasty ring (38.6 ± 1.5 mm versus 35.8 ± 2.7 mm; p < 0.001), the early postoperative resting mean gradients were higher (3.3 ± 1.2 mm Hg versus 2.6 ± 1.2 mm Hg; p = 0.007) and the mitral orifice area tended to be smaller in this group (2.8 ± 0.7 cm(2) versus 3.0 ± 0.7 cm(2); p = 0.06). The amount of residual MR was similar between groups (0.3 ± 0.6 versus 0.6 ± 1.0 for edge-to-edge versus loop procedures, respectively; p = 0.08). More than mild MR requiring early MV reoperation was present in 3 patients who underwent loop procedures (4.4%) and in no patients who had edge-to-edge procedures (p = 0.51). During follow-up, 2 patients (1 in each group) required MV replacement for severe MR. The 4-year freedom from MV reoperation was 92.8% ± 5.0% in the Alfieri group compared with 90.9% ± 4.6% in the loop group (p = 0.94). CONCLUSIONS: Minimally invasive MV repair can be accomplished with excellent early and medium-term outcomes in patients with Barlow's disease. The edge-to-edge (Alfieri) repair can be performed with reduced operative times when compared with the loop technique, but it results in mildly increased transvalvular gradients and mildly decreased valve opening areas without any difference in residual MR.

Impact of perfusion strategy on outcome after repair for acute type a aortic dissection.

BACKGROUND: The impact of antegrade versus retrograde perfusion during cardiopulmonary bypass on short- and long-term outcome after repair for acute type A aortic dissection is controversial. METHODS: We reviewed 401 consecutive patients (age, 59.2 ± 14 years) with acute type A aortic dissection who underwent aggressive resection of the intimal tear and aortic replacement (March 1995 through July 2011). Arterial perfusion was antegrade in 78% (n = 311), either by means of the right axillary artery (n = 297) or through direct aortic cannulation (n = 15). Retrograde perfusion through the femoral artery was used in 22% (n = 90). RESULTS: Of the 401 patients with acute type A aortic dissection, 16% (n = 64) presented in critical condition and 10% (n = 39) entered the operating room under cardiopulmonary resuscitation. In 14% (n = 54) the dissection did not extend beyond the ascending aorta (DeBakey II); 82% of dissections did involve at least the aortic arch (n = 326, DeBakey I+III). Mean age was not significantly different between patients undergoing antegrade (59.4 ± 14 years) versus retrograde (59.2 ± 13 years; p = 0.489) perfusion. Operative mortality was 20% and did not differ significantly between the groups (p = 0.766); postoperative stroke occurred also with a similar prevalence (antegrade, 15% versus retrograde, 18%; p = 0.623). Patients undergoing antegrade perfusion had a better long-term survival. Survival at 10 years after discharge was 71% versus 51% (p = 0.025) in favor of antegrade perfusion. Retrograde perfusion was identified to be an independent risk factor for late mortality in multivariate analysis (hazard ratio = 2; p = 0.009). CONCLUSIONS: Survival during the initial perioperative period was equivalent comparing antegrade and retrograde perfusion. Antegrade perfusion to the true lumen, however, appears to be associated with superior long-term survival after hospital discharge.