"Piggyback Pigtails": Simplifying secondary transradial access for TAVR.

Minimalist approaches have evolved for TAVR over the last years with impact on in-hospital stay and patient safety. As part of this concept, transradial secondary arterial access is capable of reducing vascular and bleeding complications. Yet, steering of the marker pigtail catheter in the descending aorta might by fluoroscopic imaging sometimes be challenging. In our manuscript, we present a very simple "piggyback" technique, simplifying management of transradial secondary access in transfemoral TAVR.

Transcatheter Aortic Valve Replacement for Isolated Aortic Regurgitation Using a New Self-Expanding TAVR System.

BACKGROUND: Patients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. OBJECTIVES: The authors describe the initial commercial experience of the first Conformité Européenne-marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR. METHODS: This multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions. RESULTS: The mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%. CONCLUSIONS: Treatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery.

A heart valve dedicated for aortic regurgitation: Review of technology and early clinical experience with the transfemoral Trilogy system.

Aortic regurgitation (AR) is associated with morbidity and premature mortality. Surgical aortic valve replacement is not an option for many patients due to an adverse surgical risk profile, whilst transcatheter aortic valve implantation with most available prostheses has demonstrated suboptimal implantation success and outcomes. The JenaValve Trilogy™ system provides an attractive solution for such patients as it utilizes clips that directly attach onto the native valve leaflets to anchor. Initially designed for transapical delivery, the current transfemoral delivery system is under investigation in the United States and approved for aortic stenosis and regurgitation in Europe. We present an expert review on the technical aspects of the Trilogy system, provide a guide for implantation, discuss the available evidence for the technology and provide illustrative case examples.

Quality of life in patients with transcatheter aortic valve implantation: an analysis from the INTERVENT project.

Background: Transcatheter aortic valve implantation (TAVI) is a standard treatment for patients with aortic valve stenosis due to its very low mortality and complication rates. However, survival and physical integrity are not the only important factors. Quality of life (QoL) improvement is a crucial part in the evaluation of therapy success. Methods: Patients with TAVI were questioned about their QoL before, one month and one year after the intervention as part of the INTERVENT registry trial at Mainz University Medical Center. Three different questionnaires were included in the data collection (Katz ADL, EQ-5D-5l, PHQ-D). Results: We included 285 TAVI patients in the analysis (mean age 79.8 years, 59.4% male, mean EuroSCORE II 3.8%). 30-day mortality was 3.6%, complications of any kind occurred in 18.9% of the patients. Main finding was a significant increase in the general state of health measured on the visual analog scale by an average of 4.53 (± 23.58) points (BL to 1-month follow-up, p = 0.009) and by 5.19 (± 23.64) points (BL to 12-month follow-up, p = 0.016). There was also an improvement of depression symptoms, which was reflected in a decrease in the total value of the PHQ-D by 1.67 (± 4.75) points (BL to 12-month follow-up, p = 0.001). The evaluation of the EQ-5D-5l showed a significant improvement in mobility after one month (M = -0.41 (± 1.31), p < 0.001. Regarding the independence of the patients, no significant difference could be found. Apart from that, patients with risk factors, comorbidities or complications also benefited from the intervention despite their poor starting position. Conclusion: We could show an early benefit of QoL in TAVI patients with significant improvement in the subjective state of health and a decrease in symptoms of depression. These findings were consistent over 1 year of follow up.

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.

3-Dimensional CT Planning for TAVR With a Novel Self-Expandable Valve in a Calcified Anatomy.

Recently, a novel transfemoral self-expandable valve (JenaValve Trilogy) was granted a CE mark as a dedicated device for transfemoral treatment of both aortic valve stenosis and regurgitation. Here, we highlight the importance of 3-dimensional preprocedural planning for the optimal choice of a prosthesis in challenging anatomies by reporting an unusual case of a heavily calcified aortic sinus.

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.

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.

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.

Long-Term Outcome with New Generation Prostheses in Patients Undergoing Transcatheter Aortic Valve Replacement.

The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014-2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications.

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

[Figure: see text].

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.

Percutaneous puncture of an aorto-bifemoral bypass graft and successful closure with MANTA® device in transfemoral TAVR.

Transfemoral aortic valve replacement (TAVR) has become a standard therapeutic option for patients with symptomatic severe aortic stenosis. Special anatomies can pose distinct challenges for vascular access and later closure of the access site, for example, in preoperated patients. Here, we elucidate a case of transfemoral TAVR with vascular access by direct puncture of an aorto-bifemoral bypass graft and illustrate the feasibility of vascular closure by an anchored collagen-plug vascular closure device (Teleflex MANTA® ).

Concomitant tricuspid regurgitation severity and its secondary reduction determine long-term prognosis after transcatheter mitral valve edge-to-edge repair.

BACKGROUND: Concomitant tricuspid regurgitation (TR) is a common finding in mitral regurgitation (MR). Transcatheter repair (TMVR) is a favorable treatment option in patients at elevated surgical risk. To date, evidence on long-term prognosis and the prognostic impact of TR after TMVR is limited. METHODS: Long-term survival data of patients undergoing isolated edge-to-edge repair from June 2010 to March 2018 (combinations with other forms of TMVR or tricuspid valve therapy excluded) were analyzed in a retrospective monocentric study. TR severity was categorized and the impact of TR on survival was analysed. RESULTS: Overall, 606 patients [46.5% female, 56.4% functional MR (FMR)] were enrolled in this study. TR at baseline was categorized severe/medium/mild/no or trace in 23.2/34.3/36.3/6.3% of the cases. At 30-day follow-up, improvement of at least one TR-grade was documented in 34.9%. Severe TR at baseline was identified as predictor of 1-year survival [65.2% vs. 77.0%, p = 0.030; HR for death 1.68 (95% CI 1.12-2.54), p = 0.013] and in FMR-patients also regarding long-term prognosis [adjusted HR for long-term mortality 1.57 (95% CI 1.00-2.45), p = 0.049]. Missing post-interventional reduction of TR severity was predictive for poor prognosis, especially in the FMR-subgroup [1-year survival: 92.9% vs. 78.3%, p = 0.025; HR for death at 1-year follow-up 3.31 (95% CI 1.15-9.58), p = 0.027]. While BNP levels decreased in both subgroups, TR reduction was associated with improved symptomatic benefit (NYHA-class-reduction 78.6 vs. 65.9%, p = 0.021). CONCLUSION: In this large study, both, severe TR at baseline as well as missing secondary reduction were predictive for impaired long-term prognosis, especially in patients with FMR etiology. TR reduction was associated with increased symptomatic benefit.

Predictors of short- and long-term outcomes of patients undergoing transcatheter mitral valve edge-to-edge repair.

OBJECTIVES: Transcatheter mitral valve repair (TMVR) by edge-to-edge therapy is an established treatment for severe mitral valve regurgitation (MR). BACKGROUND: Symptomatic and prognostic benefit in functional MR has been shown recently; nevertheless, data on long-term outcomes are sparse. METHODS AND RESULTS: We analyzed survival of patients treated with isolated edge-to-edge repair from June 2010 to March 2018 (primarily combined edge-to-edge repair with other mitral valve interventions was excluded) in a retrospective monocentric study. Overall, 627 consecutive patients (47.0% females, 78.6 years in mean) were included. Leading etiology was functional MR (57.4%). Follow-up regarding survival was available in 97.0%. While 97.6% were discharged alive, 75.7% were alive after a 1-year, 54.5% after 3-year, 37.6% after 5-year and 21.7% after 7-year follow-up. Higher logistic Euroscores and comorbidities such as COPD and renal insufficiency were associated with higher in-hospital and 1-year mortality. Importantly, in-hospital survival increased over the years. CONCLUSIONS: With the present study we established high survival rates at discharge and after 1 year of patients treated with TMVR. This goes along with high implantation numbers, increased interventional experience and a better in-hospital survival over the years. Long-term mortality in turn was substantially influenced by comorbidities.

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.