Safety of transesophageal echocardiography during transcatheter edge-to-edge tricuspid valve repair: A single-center experience.

Objectives: We aimed to determine transesophageal echocardiography (TEE) related complications during Transcatheter edge-to-edge tricuspid valve repair (TTVR). Background: Transesophageal echocardiography is essential to guide structural heart disease (SHD) interventions. TTVR has become an evolving procedure for high-risk patients not suitable for surgery. Whether this complex procedure is associated with TEE related complications is not known so far. Methods: We retrospectively analyzed 64 consecutive patients undergoing TTVR between 2019 and 2021 with the TriClip system (Abbott, Chicago, IL, USA) at our center. All procedures were performed under general anesthesia (GA). TEE related complications were classified as major and minor complications. Results: Transesophageal echocardiography related complications were observed in two patients (3.1%) with one major complication (1.6%) and one minor complication (1.6%). In one patient perforation of the esophageal mucosa requiring red blood cell transfusion was observed, the other patient had hematemesis due to minor esophageal and gastric lesions without the need for blood transfusion. Both patients recovered during hospital stay with no persistent symptoms at discharge. Conclusions: Transesophageal echocardiography related complications during TTVR are clinically relevant occurring in 3.1% of the patients. Further investigations are needed to identify potential risk factors and patients at high risk to develop a TEE related complication in the course of TTVR.

Aortic valve calcification is subject to aortic stenosis severity and the underlying flow pattern.

Sex- and flow-related aortic valve calcification (AVC) studies are still limited in number, and data on the exact calcium quantity and distribution are scarce. Therefore, we aimed to (1) re-define the best threshold of AVC load to distinguish severe from moderate aortic stenosis (AS) in common AS entities and to (2) evaluate differences in the aortic annulus and left ventricular outflow tract (LVOT) calcium load. Nine hundred and thirty-eight patients with contrast-enhanced cardiac MSCT and moderate-to-severe aortic stenosis (AS) were retrospectively enrolled. Patients with severe AS ≤ 1.0 cm2 (n = 841) were further separated into three AS entities: high gradient (HGAS, n = 370, 44.0%), paradoxical low gradient (pLGAS, n = 333, 39.6%), and classical low gradient (LGAS, n = 138, 16.4%). AVC, leaflet, and LVOT calcification were quantified. Aortic valve calcification scores were highest in severe HGAS, and lower in severe pLGAS and classical LGAS. In all severity and AS entities, the non-coronary cusp (NCC) was the most calcified one. LVOT calcification was consistently comparable between gender and AS entities. Accuracy of logistic regression was the highest in HGAS (male vs. female: AVC > 2156 Agatston units (AU), c-index 0.76; vs. AVC > 1292 AU, c-index 0.85; or AVC density > 406 AU/cm2, c-index 0.82; vs. > 259 AU/cm2, c-index 0.86; each p < 0.0001*) to diagnose severe AS. AVC could only be used in men to differentiate between severe LGAS and moderate AS. Data from this retrospective analysis indicate that the NCC is subject to pre-dominant degeneration throughout gender, AS severity, and several AS entities. AVC was consistently comparable in severe pLGAS and classical LGAS, but only AVC in severe LGAS could sufficiently distinguish from moderate AS in men. LVOT calcification failed to be a reliable indicator of accelerating AS.

Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score Matched Analysis.

BACKGROUND: The CoreValve Evolut R and PRO (Medtronic, Minneapolis, MN, USA) are among the newest-generation of self-expandable transcatheter aortic valve replacement (TAVR) devices and show excellent results. Treating patients with severely calcified (SC) native aortic valve anatomy may be challenging because of the increased risk of periprocedural complications. This study investigated the performance of Evolut R and PRO in this special patient subset. METHODS: Patients who underwent TAVR with the CoreValve Evolut R or PRO (n=381) from September 2015 to March 2018 were divided by aortic valve calcification extent. Patients with SC aortic valve anatomy (n=98; men, >2,062 and women, >1,377 Agatston units) were compared with those with non-severely calcified (NCS) aortic valve anatomy after 1:2 propensity score matching. Outcomes were evaluated according to the updated valve academic research consortium criteria. RESULTS: Patients with SC anatomy were older (83 years vs 80 years, p<0.001) and had a smaller aortic valve area (0.63 cm2 vs 0.70 cm2, p=0.028). Pre-dilatation was more often performed (30.6% vs 15.8%, p=0.003) and a permanent pacemaker implantation was more often necessary (32.9% vs 8.8%, p<0.001) in the SC group. None/mild aortic regurgitation (AR) was evenly distributed (SC, 96.9% vs NCS, 99.5%, p=0.109); moderate AR was present in 3.1% of SC patients and in 0.5% of NSC patients. Severe AR was not observed. CONCLUSION: The CoreValve Evolut R and PRO showed good clinical safety profiles and excellent haemodynamic results in patients with SC anatomy and who more often required permanent pacemaker implantation.

TAVR-related echocardiographic assessment - status quo, challenges and perspectives.

Transcatheter aortic valve replacement (TAVR) is an emerging and a well-established procedure for high-risk and inoperable patients worldwide. Recent studies revealed furthermore that TAVR is equal or even superior to surgical valve replacement in intermediate risk patients. Therefore, a successful procedure is not only dependent on precise preprocedural patient selection but also on careful intraprocedural multimodal imaging guidance and adequate postprocedural follow-up. Up to date, 2D/3D transthoracic and/or transoesophageal echocardiography is an easy and goal-oriented tool for periprocedural TAVR-assessment regarding annulus measurements, cardiac function and concomitant valve diseases. Further procedural success is directly related to prevention of severe early and late complications. Thus, a careful intra- and postprocedural echocardiographic guidance is crucial to evaluate prosthetic function, position and its haemodynamic implication and changes in the integrity of the left ventricle during intra- and postprocedural management. We explored the role of echocardiography for pre-, intra- and postprocedural TAVR-assessment, illustrated by cases and possible algorithms, in a comprehensive literature review. Furthermore, we describe the role of fusion imaging, that is, real-time fusion of transoesophageal echocardiography and fluoroscopy (EchoNavigator Release System® I and II) during TAVR.

Contrary to Expectations: Off-Label Transcatheter Aortic Valve Replacement in the Case of Left Ventricular Outflow Tract Obstruction.

We present the case of a 71-year-old woman who showed recurrent signs of congestive heart failure with the need of rehospitalization after double valve (mitral and aortic) replacement. Extensive diagnostic workup revealed a moderate aortic stenosis and additionally a significant left ventricular outflow tract obstruction. The tissue overgrowth might be attributed to an inflammatory reaction with extensive pannus deposit after aortic valve surgery. With no-option for re-do surgery we performed the first-in-man off-label valve-in-left ventricular outflow tract procedure with an Edwards Sapien III 23 mm in deep orientation.

Balloon Valvuloplasty Followed by Transcatheter Aortic Valve Implantation as a Staged Procedure in Patients With Low-Flow Low-Gradient Aortic Stenosis.

OBJECTIVE: Balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve implantation (TAVI) is a well-established treatment option in patients who are in a critical state or who suffer from underlying comorbidities that disguise the severity of aortic stenosis (AS). If convalescence is achieved, TAVI can be performed with good results in high-gradient aortic stenosis (HG-AS) patients. Whether this approach is safe and effective in low-flow low-gradient aortic stenosis (LFLG-AS) has not been analyzed; therefore, we investigated whether BAV followed by TAVI as a staged procedure is an effective treatment option in patients with LFLG-AS. METHODS: Patients with severe AS who received BAV followed by staged TAVI were identified. Baseline data, periprocedural and postprocedural information, echocardiographic data, and follow-up data were collected. The patient population was divided into LFLG-AS and HG-AS groups. RESULTS: From July 2009 until September 2017, we identified 38 eligible patients (16 LFLG-AS and 22 HG-AS). Log EuroScore I (51.8 ± 20.9% LFLG-AS vs 33.7 ± 19.1% HG-AS; P<.01) differed significantly between groups, as did baseline echocardiographic data that were used to categorize groups. BAV and staged TAVI were carried out 100% successfully with comparable results. Instant symptom relief and pressure gradient reduction were accomplished after both procedures. Thirty-day mortality rates (0% LFLG-AS vs 9% HG-AS; P=.21) and 1-year mortality rates (18.8% LFLG-AS vs 27.2% HG-AS; P=.54) did not differ between groups. CONCLUSION: BAV followed by staged TAVI is a safe and effective treatment option in sick or questionable candidates, irrespective whether LFLG-AS or HG-AS is present.

Deep sedation Vs. general anesthesia in 232 patients undergoing percutaneous mitral valve repair using the MitraClip® system.

OBJECTIVES: To investigate in a series of 232 patients whether the MitraClip® procedure can be performed safely using deep sedation (DS) without general anesthesia (GA). BACKGROUND: Transcatheter mitral valve repair using the MitraClip® system is a safe and effective therapy for severe mitral regurgitation (MR) in patients who are at high operative risk or are unsuitable for surgery. For these patients, avoidance of GA might be beneficial. METHODS: Between 2011 and 2015, we performed 232 MitraClip® procedures for the treatment of severe MR. Of those, 76 procedures were performed using GA, while the remaining 156 procedures were performed using DS. RESULTS: Age, logistic EuroScore, severity of MR, left and right ventricular function, and renal function did not differ between the groups. The primary combined safety endpoint, which was defined as the occurrence of major adverse cardiac and cerebrovascular events, conversion to surgery, major vascular complications or pneumonia, did not differ between MitraClip® procedures performed using GA and MitraClip® procedures performed using DS. Intraprocedural conversion to GA was required in 2% of the patients in the DS group. There were no differences in procedural success or clinical outcome between the groups at the 3-month follow-up. Preparation time in the catheterization laboratory and intensive care unit (ICU) stay were shorter in the DS group compared to the GA group. CONCLUSION: The MitraClip® implantation performed using DS is as safe and effective as MitraClip® implantation performed using GA. © 2017 Wiley Periodicals, Inc.

Percutaneous mitral valve repair using the MitraClip system in patients with anemia.

BACKGROUND: Patients with anemia show a negative outcome in percutaneous coronary intervention, transcatheter aortic valve replacement and cardiac surgery. The impact of anemia on periprocedural major adverse cardiac and cerebrovascular events (MACCE) and mortality in patients undergoing treatment of severe mitral regurgitation (MR) with percutaneous mitral valve repair using the MitraClip system is not known. OBJECTIVE: To assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with anemia. METHODS AND RESULTS: 80 patients with severe and moderate-to-severe MR were included in this open-label observational single-center study. Anemia was prevalent in 51.3% of patients (n=41). MitraClip devices were successfully implanted in 97.6% (n=40) of patients with anemia and in 97.4% (n=38) of patients without anemia (p=0.971). Periprocedural MACCE occurred in 4.9% (n=2) of patients with anemia and 5.1% (n=2) of patients without anemia (p=0.959). Thirty-day mortality was 2.4% (n=1) in patients with anemia and 5.1% (n=2) in patients without anemia (p=0.611). Follow up of up to 12 months showed a significant improvement of NYHA class and quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire in both groups. One-year survival was 80.5% in patients with anemia and 84.6% in patients without anemia (p=0.634). CONCLUSION: Mitral valve repair with the MitraClip system can be performed safely and efficiently in patients with anemia. Anemia does not affect clinical outcome and quality of life in patients undergoing mitral valve repair.

Safety and efficacy of percutaneous mitral valve repair using the MitraClip® system in patients with diabetes mellitus.

BACKGROUND: Patients with diabetes mellitus show a negative outcome in percutaneous coronary intervention, aortic valve replacement and cardiac surgery. The impact of diabetes on patients undergoing treatment of severe mitral regurgitation (MR) using the MitraClip system is not known. We therefore sought to assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with diabetes mellitus. METHODS AND RESULTS: We included 58 patients with severe and moderate-to-severe MR in an open-label observational single-center study. Ninteen patients were under oral medication or insulin therapy for type II diabetes mellitus. MitraClip devices were successfully implanted in all patients with diabetes and in 97.4% (n = 38) of patients without diabetes (p = 0.672). Periprocedural major cardiac adverse and cerebrovascular events (MACCE) occurred in 5.1% (n = 2) of patients without diabetes whereas patients with diabetes did not show any MACCE (p = 0.448). 30-day mortality was 1.7% (n = 1) with no case of death in the diabetes group. Short-term follow up of three months showed a significant improvement of NYHA class and quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire in both groups, with no changes in the 6-minute walk test. CONCLUSIONS: Mitral valve repair with the MitraClip system is safe and effective in patients with type II diabetes mellitus. TRIAL REGISTRATION: MitraClip Registry NCT02033811.