Valve unit instead of intensive or intermediate care unit admission following transcatheter edge-to-edge mitral valve repair is safe and reduces postprocedural complications.

BACKGROUND: Transcatheter edge-to-edge mitral valve repair (M-TEER) is often performed in general anesthesia, and postprocedural monitoring is usually warranted on an intensive or intermediate care unit (ICU/IMC). We evaluated the implications of a dedicated valve unit (VU) instead of an ICU/IMC for monitoring after M-TEER. METHODS AND RESULTS: In total, 624 patients were retrospectively analyzed. A total of 312 patients were primarily transferred to either ICU or IMC following M-TEER, and 312 patients were scheduled for the VU in the absence of indications for ICU/IMC treatment. Hospital stay was significantly shorter in VU patients (median 6.0 days (interquartile range (IQR) 5.0 - 8.0) vs. 7.0 days (IQR 6.0 - 10.0), p < 0.001) and their risk for infections (2.9 vs. 7.7%, p = 0.008) and delirium (0.6 vs. 2.6%, p = 0.056) was substantially lower compared to ICU/IMC patients. In-hospital mortality was similar in both groups (0.6% vs. 1.3%, p = 0.41). Fifty patients (16.0%) in the VU group had to cross over to unplanned ICU/IMC admission. The most frequent indication was prolonged need for catecholamines (52.0%). Patients with ICU/IMC crossover had more advanced stages of heart failure (LV-EF < 30% in 36.0 vs. 16.0%, p = 0.001; severe concomitant tricuspid regurgitation in 48.0 vs. 27.8%, p = 0.005) and an LV-EF < 30% was independently associated with unplanned ICU/IMC admission. CONCLUSIONS: Following M-TEER postprocedural monitoring on a VU instead of an ICU/IMC is safe, reduces complications, and spares ICU capacities. Patients with advanced heart failure have a higher risk for unplanned ICU/IMC treatment after M-TEER.

The effect of a smaller spacer in the PASCAL Ace on residual mitral valve orifice area.

BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is an established treatment for functional mitral regurgitation (FMR) associated with a risk of creating iatrogenic stenosis. OBJECTIVES: To investigate the impact of the P10 and its larger spacer compared to the narrower Ace and its smaller spacer on reduction of mitral valve orifice area (MVOA) during M-TEER. METHODS: Consecutive patients undergoing M-TEER for treatment of severe FMR were screened retrospectively. Patients with a single PASCAL device implantation within the central segments of the MV leaflets, non-complex anatomy, and baseline MVOA ≥ 3.5cm2 were selected. Intraprocedural transesophageal echocardiography was used to compare MVOA reduction with 3D multiplanar reconstruction and direct planimetry. Device selection did not follow a prespecified MVOA threshold. RESULTS: Seventy-two patients (81.0 years, IQR {74.3-85.0}) were included. In 32 patients, the P10 was implanted (44.4%). MR severity (p = 0.66), MR reduction (p = 0.73), and body surface area (p = 0.56) were comparable. Baseline MVOA tended to be smaller in P10 patients with the larger spacer (5.0 ± 1.1 vs. 5.4 ± 1.3cm2, p = 0.18), however, residual MVOA was larger in these patients (2.7 ± 0.7 vs. 2.3 ± 0.6cm2, p = 0.03). Accordingly, relative MVOA reduction was significantly less in P10 patients (- 45.9 ± 7.6 vs. - 56.3 ± 7.0%, p < 0.01). Indirect annuloplasty was more pronounced in Ace patients whereas mean transmitral gradients were similar. CONCLUSION: In FMR patients with non-complex anatomy, the larger spacer of the P10 maintains greater MVOA with similar MR reduction. Hence, the use of the PASCAL Ace device in patients with small MVOAs might correlate with a risk of both clinically relevant orifice reduction and even iatrogenic stenosis.

Impact of cardiac and respiratory motion on the 3D accuracy of image-guided interventions on monoplane systems.

PURPOSE: Image-guided intervention (IGI) systems have the potential to increase the efficiency in interventional cardiology but face limitations from motion. Even though motion compensation approaches have been proposed, the resulting accuracy has rarely been quantified using in vivo data. The purpose of this study is to investigate the potential benefit of motion-compensation in IGS systems. METHODS: Patients scheduled for left atrial appendage closure (LAAc) underwent pre- and postprocedural non-contrast-enhanced cardiac magnetic resonance imaging (CMR). According to the clinical standard, the final position of the occluder device was routinely documented using x-ray fluoroscopy (XR). The accuracy of the IGI system was assessed retrospectively based on the distance of the 3D device marker location derived from the periprocedural XR data and the respective location as identified in the postprocedural CMR data. RESULTS: The assessment of the motion-compensation depending accuracy was possible based on the patient data. With motion synchronization, the measured accuracy of the IGI system resulted similar to the estimated accuracy, with almost negligible distances of the device marker positions identified in CMR and XR. Neglection of the cardiac and/or respiratory phase significantly increased the mean distances, with respiratory motion mainly reducing the accuracy with rather low impact on the precision, whereas cardiac motion decreased the accuracy and the precision of the image guidance. CONCLUSIONS: In the presented work, the accuracy of the IGI system could be assessed based on in vivo data. Motion consideration clearly showed the potential to increase the accuracy in IGI systems. Where the general decrease in accuracy in non-motion-synchronized data did not come unexpected, a clear difference between cardiac and respiratory motion-induced errors was observed for LAAc data. Since sedation and intervention location close to the large vessels likely impacts the respiratory motion contribution, an intervention-specific accuracy analysis may be useful for other interventions.

Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial; NCT03706833) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. METHODS: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. RESULTS: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). CONCLUSIONS: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study.

BACKGROUND: A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy. OBJECTIVES: The aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk. METHODS: This prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory. RESULTS: A total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg). CONCLUSIONS: The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363).

Predictors of Improvement in Concomitant Tricuspid Regurgitation Following Transcatheter Edge-to-Edge Mitral Valve Repair.

BACKGROUND: Improvement in concomitant tricuspid regurgitation (TR) after mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation (MR) occurs frequently; however factors determining the post-procedural course of TR are not well understood. We investigated the parameters associated with TR improvement after M-TEER. METHODS AND RESULTS: A total of 300 patients were consecutively included in this retrospective analysis. MR and TR severity as well as heart chamber metrics were assessed before the procedure and at follow-up. Device success was achieved in 97.3% of patients. TR decreased in 30.2% of patients. Patients with improved TR were more often female, had more severe TR at baseline, and their right heart dimensions at baseline trended to be smaller. Female sex (odds ratio (OR) 2.997), baseline MR-Grade (OR 3.181) and baseline TR-Grade (OR 2.653) independently predicted TR reduction. More pronounced right heart reverse remodeling was observed in patients with improved TR. TR regression independently predicted lower mortality (hazard ratio (HR) 0.333, 95% confidence interval 0.112-0.996, p = 0.049). CONCLUSIONS: A reduction in concomitant TR severity after M-TEER occurred mainly in females and in patients with high-grade TR and MR at baseline. TR regression is associated with better survival after M-TEER.

Transcatheter edge-to-edge-repair of functional mitral regurgitation induces significant remodeling of mitral annular geometry.

Background: Mitral annular alterations in the context of heart failure often lead to severe functional mitral regurgitation (FMR), which should be treated with transcatheter edge-to-edge repair (M-TEER) according to current guidelines. M-TEER's effects on mitral valve (MV) annular remodeling have not been well elucidated. Methods: 141 consecutive patients undergoing M-TEER for treatment of FMR were included in this investigation. Comprehensive intraprocedural transesophageal echocardiography was used to assess the acute effects of M-TEER on annular geometry. Results: Average patient age was 76.2 ± 9.6 years and 46.1% were female patients. LV ejection fraction was reduced (37.0% ± 13.7%) and all patients had mitral regurgitation (MR) grade ≥III. M-TEER achieved optimal MR reduction (MR ≤ I) in 78.6% of patients. Mitral annular anterior-posterior diameters (A-Pd) were reduced by -6.2% ± 9.5% on average, whereas anterolateral-posteromedial diameters increased (3.7% ± 8.9%). Overall, a reduction in MV annular areas was observed (2D: -1.8% ± 13.1%; 3D: -2.7% ± 13.7%), which strongly correlated with A-Pd reduction (2D: r = 0.6, p < 0.01; 3D: r = 0.65, p < 0.01). Patients that achieved A-Pd reduction above the median (≥6.3%) showed significantly lower rates of the composite endpoint rehospitalization for heart failure or all-cause mortality than those with less A-Pd reduction (9.9% vs. 28.6%, p = 0.037, log-rank p = 0.039). Furthermore, patients reaching the composite endpoint had an increase in annular area (2D: 3.0% ± 15.4%; 3D: 1.9% ± 15.3%), whereas those not reaching the endpoint showed a decrease (2D: -2.7% ± 12.4%; 3D: -3.6% ± 13.3%), although residual MR after M-TEER was similar between these groups (p = 0.57). In multivariate Cox regression adjusted for baseline MR, A-Pd reduction ≥6.3% remained a significant predictor of the combined endpoint (OR: 0.35, 95% CI: 0.14-0.85, p = 0.02). Conclusion: Our findings indicate that effects of M-TEER in FMR are not limited to MR reduction, but also have significant impact on annular geometry. Moreover, A-Pd reduction, which mediates annular remodeling, has a significant impact on clinical outcome independent of residual MR.

Diabetes Mellitus in Patients Undergoing Mitral Transcatheter Edge-to-Edge Repair-A Decade Experience in 1000+ Patients.

BACKGROUND: Diabetes mellitus worsens outcomes in patients suffering from heart disease undergoing cardiac procedures. OBJECTIVES: To investigate the impact of diabetes in patients undergoing mitral transcatheter edge-to-edge repair (M-TEER). METHODS: 1118 patients treated with M-TEER for functional (FMR) and degenerative (DMR) mitral regurgitation (MR) between 2010 and 2021 were analyzed using the combined endpoint of death/rehospitalization for heart failure (HFH). RESULTS: Among diabetics (N = 306; 27.4%), comorbidities such as coronary artery disease (75.2% vs. 62.7%; p < 0.001) and progressed (stage III/IV) chronic kidney disease (79.5% vs. 72.6%; p = 0.018) were more frequent. The rate of FMR was higher in diabetics (71.9% vs. 64.5%; p < 0.001). The combined endpoint occurred more frequently in diabetics (40.2% vs. 35.6%; log-rank = 0.035). While no difference was observed in FMR patients (36.8% vs. 37.6%; log-rank p = 0.710), rates of the combined endpoint differed significantly between diabetics and non-diabetics in DMR patients (48.8% vs. 31.9%; log-rank p = 0.001) only. However, diabetes did neither predict the combined endpoint in the overall (OR: 0.97; 95% CI 0.65-1.45; p = 0.890) nor in the DMR cohort (OR: 0.73; 95% CI 0.35-1.51; p = 0.389). Among diabetics treated with M-TEER, troponin (OR: 2.32; 95% CI 1.3-3.7; p = 0.002) and estimated glomerular filtration rate (OR: 0.52; 95% CI 0.3-0.88; p = 0.018) independently predicted the combined endpoint. CONCLUSIONS: Diabetes is associated with adverse outcomes after M-TEER, particularly in DMR patients. However, diabetes does not predict the combined endpoint. In diabetics undergoing M-TEER, biochemical markers associated with organ function and damage independently predict the combined endpoint of death and rehospitalization.

MRI-based training model for left atrial appendage closure.

PURPOSE: Percutaneous closure of the left atrial appendage (LAA) reduces the risk of embolic stroke in patients with atrial fibrillation. Thereby, the optimal transseptal puncture (TSP) site differs due to the highly variable anatomical shape of the LAA, which is rarely considered in existing training models. Based on non-contrast-enhanced magnetic resonance imaging (MRI) volumes, we propose a training model for LAA closure with interchangeable and patient-specific LAA enabling LAA-specific identification of the TSP site best suited. METHODS: Based on patient-specific MRI data, silicone models of the LAAs were produced using a 3D-printed cast model. In addition, an MRI-derived 3D-printed base model was set up, including the right and left atrium with predefined passages in the septum, mimicking multiple TSP sites. The various silicone models and a tube mimicking venous access were connected to the base model. Empirical use of the model allowed the demonstration of its usability. RESULTS: Patient-specific silicone models of the LAA could be generated from all LAA patient MRI datasets. The influence of various combinations regarding TSP sites and LAA shapes could be demonstrated as well as the technical functionality of the occluder system. Via the attached tube mimicking the venous access, the correct handling of the deployment catheter even in case of not optimal puncture site could be practiced. CONCLUSION: The proposed contrast-agent and radiation-free MRI-based training model for percutaneous LAA closure enables the pre-interventional assessment of the influence of the TSP site on the access of patient-specific LAA shapes. A straightforward replication of this work is measured by using clinically available imaging protocols and a widespread 3D printer technique to build the model.

Prevalence of iatrogenic atrial septal defects (iASD) after mitral valve (MV) transcatheter edge-to-edge repair (TEER) in the long-term follow-up.

OBJECTIVES: To investigate prevalence of iatrogenic atrial septal defects (iASDs) after mitral valve (MV) transcatheter edge-to-edge repair (TEER) with the MitraClip in the long-term follow-up. BACKGROUND: MV TEER requires transseptal puncture using a large 22 F sheath. Prevalence, impact and haemodynamic effects of these iASDs remain unknown in the long-term follow-up. METHODS: This prospective study enrolled patients who had undergone first-time TEER at our university hospital between January 2017 and June 2018 for a clinical long-term follow-up study. Prevalence of iASD was investigated 12 months post-TEER using transoesophageal echocardiography (TEE). Study protocol further consisted of transthoracic echocardiography (TTE) and exercise testing. Incidence of all-cause death was compared 12 months post-TEE follow-up. This study was approved by local ethics committee. RESULTS: 48 patients participated in clinical follow-up examinations. Median time between TEER and clinical follow-up examination (TEE, TTE, exercise testing) was 19.5 (IQR: 7.0) months after TEER. Persistent iASD was found in 41.7% of patients. TEER was found to be equally effective in reducing MR and clinical symptoms in both groups at baseline as well as follow-up. Procedural fluoroscopy and device times were significantly longer in the iASD group. MR reduction and functional status (New York Heart Association Class, 6 Minute Walking Test distance) were similar in both groups. Nevertheless, a significant decrease in systolic pulmonary artery pressure (sPAP) and significantly smaller atrial diameters were observed in patients with iASD at follow-up. CONCLUSION: Prevalence of iASDs after TEER in long-term follow-up was about 41%. Although a significant reduction of sPAP and better left atrial reverse remodelling were accomplished in patients with iASD, clinical impact appears low. Manipulation at the atrial septum might play a key role in creating persisting iASD.

Percutaneous edge-to-edge mitral valve repair for mitral regurgitation improves heart failure symptoms in heart failure with preserved ejection fraction patients.

AIMS: Therapeutic options for patients with heart failure with preserved ejection fraction (HFpEF) are sparse. Mitral regurgitation (MR) is a common feature of HFpEF and worsens heart failure symptoms and prognosis. Our study examines the outcome of patients with preserved left ventricular ejection fraction (LVEF) and elevated left atrial (LAP) or left ventricular filling pressures (LVEDP), indicative of HFpEF, after undergoing percutaneous edge-to-edge mitral valve repair (pMVR) for moderate-severe MR. METHODS AND RESULTS: Two hundred eleven patients with preserved LVEF (>50%), who underwent pMVR, were dichotomized by LAP (< / ≥15 mmHg) and LVEDP (< / ≥16 mmHg). Forty-nine per cent of patients showed elevated LAP, and LVEDP was elevated in 55%, both indicating HFpEF. Patients with elevated filling pressures featured typical clinical characteristics of HFpEF, higher N-terminal pro-brain natriuretic peptide levels (5544.9 pg/mL in high LAP group vs. 3071.7 pg/mL in normal LAP group, P = 0.06; 5061.0 pg/mL in high LVEDP group vs. 3230.3 pg/mL in normal LVEDP group, P = 0.08), and higher prevalence of pulmonary hypertension (mean pulmonary artery pressure 36.4 mmHg in high LAP group vs. 26.3 mmHg in normal LAP group, P < 0.001; 35.2 mmHg in high LVEDP group vs. 29.7 mmHg in normal LVEDP group, P = 0.004) and atrial fibrillation (78.8% in normal LAP group vs. 61.0% in high LAP group, P = 0.04; 75.3% in high LVEDP group vs. 67.5% in normal LVEDP group, P = 0.25). Pre-treatment MR grade and New York Heart Association (NYHA) class were similar in both normal filling pressure and HFpEF groups. pMVR in HFpEF patients achieved effective heart failure symptom relief comparable with patients with normal filling pressures: significant decrease of MR grade and NYHA class, as well as significant reduction of heart failure hospitalizations 12 months after compared with 12 months before MitraClip. CONCLUSION: Percutaneous edge-to-edge mitral valve repair for moderate-severe MR is an effective treatment option for symptom relief in HFpEF patients.

Implications of concomitant obstructive or restrictive pulmonary diseases on functional and clinical results after MitraClip.

OBJECTIVES: We investigated the impact of underlying pulmonary limitations (PL) on symptoms and clinical outcomes after transcatheter mitral valve repair (TMVr). BACKGROUND: Patients with pulmonary disease and patients with symptomatic mitral regurgitation (MR) suffer common symptoms like dyspnea and reduced exercise capacity. METHODS: Datasets from the TMVr Ulm registry were retrospectively analyzed by a blinded specialist in pneumology. Patients were dichotomized according to an unambiguous manifestation of concomitant pulmonary disease in a PL-group and a non-PL-group and were analyzed regarding baseline characteristics and clinical follow-up. RESULTS: Overall, 483 patients were included in the study of which 32.3% (n = 156) showed an underlying pulmonary disease. Patients in the PL-group were similar to patients in the non-PL-group, including Euro SCORE II (8.2 vs. 8.4, p = 0.39), New York Heart Association (NYHA) classification (3.2 ± 0.7 in both groups, p = 0.65) and the incidence of moderate-to-severe or severe MR after TMVr (5.8 vs. 8.3%, p = 0.32). Equal and significant symptom relief after TMVr was experienced in both cohorts according to NYHA functional class (2.24 ± 0.84 vs. 2.24 ± 0.86, p = 0.93) and rate of hospitalization during 2 years of follow-up decreased comparably from 61.1 to 19.3%. However, all-cause mortality for 2 year follow-up was significantly higher in the PL-group compared to the non-PL-group (31.4 vs. 21.4%, p = 0.018). CONCLUSION: In patients with MR and concomitant pulmonary disorders, a significant increase of exercise capacity and a significant decrease of rehospitalization rate were observed after TMVr. Nevertheless, all-cause mortality remains significantly increased within a follow-up period of 2 years compared to patients without pulmonary disorders.

Predictors of left ventricular reverse remodeling after percutaneous therapy for mitral regurgitation with the MitraClip system.

OBJECTIVES: To investigate the predictors and clinical impact of left ventricular reverse remodeling (LVRR) after MitraClip (MC) therapy for degenerative (DMR) and functional mitral regurgitation (FMR). BACKGROUND: MC therapy induces LVRR in patients with mitral regurgitation (MR) at high-risk for surgery. However, specific data on predictors of LVRR therapy are limited. METHODS: This study included 164 patients treated by MC implantation with complete clinical and echocardiographic evaluation at baseline, 6 months, and 12 months. LVRR was defined as a decrease of ≥10% of the left ventricular end-diastolic diameter after 12 months and was found in 49% of the patients. RESULTS: LVRR was associated with significantly reduced event rate 2 years after MC procedure. In the total cohort, multivariate regression analysis determined severe recurrent/residual MR after 12 months (p = .010, odds ratio [OR] = 0.26), male gender (p = .050, OR = 0.49) and left ventricular ejection fraction (LVEF) <20% (p = .046, OR = 0.24) as predictors of absence of LVRR. In the subgroup analysis according to etiology of MR, multivariate regression analysis revealed severe recurrent/residual MR after 12 months (p = .04, OR = 0.184) to inversely predict LVRR only in the DMR subgroup. In FMR, residual severe tricuspid regurgitation (TR) inversely predicts LVRR (p = .032, OR = 0.361). CONCLUSIONS: LVRR occurs in half of the patients after MC and is associated with reduced MACCE rates at follow-up. Combined information on residual/recurrent MR, baseline LVEF and gender predict LVRR after MC procedure. While residual/recurrent MR is the independent predictor for the absence of LVRR in DMR, in FMR only severe residual TR independently predict LVRR.