Contemporary use of balloon aortic valvuloplasty and evaluation of its success in different hemodynamic entities of severe aortic valve stenosis.

OBJECTIVES: To evaluate outcome assessment of percutaneous balloon aortic valvuloplasty (BAV) in different flow and gradient patterns of severe aortic stenosis (AS). BACKGROUND: The mean pressure gradient reduction after BAV is an often-used surrogate parameter to evaluate procedural success. The definition of a successful BAV has not been evaluated in different subgroups of severe AS, which were introduced in the latest guidelines on the management of patients with valvular heart disease. METHODS: In this observational study, consecutive patients from July 2009 to March 2018 undergoing BAV were divided into normal-flow high-gradient (NFHG), low-flow low-gradient (LFLG), and paradoxical low-flow low-gradient (pLFLG) AS. Baseline characteristics, hemodynamic, and clinical information were collected and compared. RESULTS: One-hundred-fifty-six patients were grouped into NFHG (n = 68, 43.5%), LFLG (n = 68, 43.5%), and pLFLG (n = 20, 12.8%) AS. Mean age of the study population was 81 years. Cardiogenic shock or refractory heart failure (46.8%) was the most common underlying reasons for BAV. Spearman correlation revealed that the mean pressure gradient reduction, determined by echocardiography, had a moderate correlation with the increase in the aortic valve area (AVA) in patients with NFHG AS (ρ: 0.529, p < .001) but showed no association in patients with LFLG (ρ: 0.017, p = .289) and pLFLG (ρ: 0.030, p = .889) AS. BAV as bridge to surgical or transcatheter aortic valve replacement was possible in 44.2% of patients, with no difference between groups (p = .070). CONCLUSION: The mean pressure gradient reduction might be an adequate surrogate parameter for BAV success in patients with NFHG AS but is not suitable for patients with other hemodynamic entities.

Predictors of functional mitral regurgitation recurrence after percutaneous mitral valve repair.

We aimed to identify predictors of mitral regurgitation recurrence (MR) after percutaneous mitral valve repair (PMVR) in patients with functional mitral regurgitation (FMR). Patients with FMR were enrolled who underwent PMVR using the MitraClip® device. Procedural success was defined as reduction of MR of at least one grade to MR grade ≤ 2 + assessed at discharge. Recurrence of MR was defined as MR grade 3 + or worse at one year after initially successful PMVR. A total of 306 patients with FMR underwent PMVR procedure. In 279 out of 306 patients (91.2%), PMVR was successfully performed with MR grade ≤ 2 + at discharge. In 11.4% of these patients, MR recurrence of initial successful PMVR after 1 year was observed. Recurrence of MR was associated with a higher rate of heart failure rehospitalization during the 12 months follow-up (52.0% vs. 30.3%; p = 0.029), and less improvement in New York Heart Association (NYHA) functional class [68% vs. 19% of the patients presenting with NYHA functional class III or IV one year after PMVR when compared to patients without recurrence (p = 0.001)]. Patients with MR recurrence were characterized by a higher left ventricular sphericity index {0.69 [Interquartile range (IQR) 0.64, 0.74] vs. 0.65 (IQR 0.58, 0.70), p = 0.003}, a larger left atrium volume [118 (IQR 96, 143) ml vs. 102 (IQR 84, 123) ml, p = 0.019], a larger tenting height 10 (IQR 9, 13) mm vs. 8 (IQR 7, 11) mm (p = 0.047), and a larger mitral valve annulus [41 (IQR 38, 43) mm vs. 39 (IQR 36, 40) mm, p = 0.015] when compared to patients with durable optimal long-term results. In a multivariate regression model, the left ventricular sphericity index [Odds Ratio (OR) 1.120, 95% Confidence Interval (CI) 1.039-1.413, p = 0.003)], tenting height (OR 1.207, 95% CI 1.031-1.413, p = 0.019), and left atrium enlargement (OR 1.018, 95% CI 1.000-1.038, p = 0.047) were predictors for MR recurrence after 1 year. In patients with FMR, baseline parameters of advanced heart failure such as spherical ventricle, tenting height and a large left atrium might indicate risk of recurrent MR one year after PMVR.

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.

Impact of Combined "CHADS-BLED" Score to Predict Short-Term Outcomes in Transfemoral and Transapical Aortic Valve Replacement.

BACKGROUND: High CHA2DS2-VASC and HAS-BLED scores are linked to increased mortality in structural and nonstructural cardiovascular interventions irrespective of the presence of atrial fibrillation (AF) or oral anticoagulation. We aimed to use the aforementioned scores to quantify the risk of 30-day mortality, major vascular and bleeding events (MVASC/BARC), and cerebrovascular insults (CVI) in patients undergoing different access routes in transcatheter aortic valve replacement (TAVR). METHODS: Out of 1329 patients, 980 transfemoral (TF) TAVR (73.7%) and 349 transapical (TA) TAVR (26.3%) were included. CHA2DS2-VASC, HAS-BLED, and combined "CHADS-BLED" scores were calculated and compared to the predictive value of the established EuroSCORE and STS score. RESULTS: In all-comers TF TAVR patients, the applied risk models showed only poor association with 30-day mortality while, in patients with concomitant AF, a strong association was observed using the combined CHADS-BLED score (c-index: 0.83; 95% CI: 0.76-0.91; p < 0.0001). Concerning 30-day mortality, only the STS score for TF TAVR (c-index: 0.68; 95% CI: 0.59-0.76; p = 0.001) and EuroSCORE for TA TAVR (c-index: 0.66; 95% CI: 0.56-0.76; p = 0.005) could show some predictive value. High CHADS-BLED was associated with enhanced CVI (3.0% vs. 7.2%;p=0.0039 ∗ ) and more frequent MVASC/BARC (3.2% vs. 6.3%; p = 0.0362) in the all-comers TAVR cohort. All risk models failed in the prediction of CVI and MVASC/BARC for TA TAVR patients. CONCLUSION: The combined CHADS-BLED score was a strong predictor for 30-day mortality in TF TAVR patients with AF. A high CHADS-BLED score showed a good predictive value for major vascular and bleeding events as well as CVI in TF TAVR patients. This study is registered at clinical trials (NCT01805739).

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.

Valvuloplasty balloon entrapment in a self-expanding aortic valve stent frame after inadvertent wire passage through the outflow struts.

Transcatheter aortic valve replacement (TAVR) is a leading-edge therapy option for patients with severe aortic stenosis (AS) and high surgical risk. However, this minimally invasive procedure is associated with specific complications that may be life-threatening. Valvuloplasty balloon entrapment during postdilatation in transcatheter self-expanding aortic valve stent frames has not yet been a focus of interest in this context. Although it is a rare event, it may critically influence outcome, and different management strategies can be considered. Hereafter, we present the case of a 67-year-old male who underwent transfemoral TAVR and subsequent postdilatation. The valvuloplasty balloon was entrapped in the self-expanding aortic valve stent frame after inadvertent wire passage through the outflow struts. Since surgical risk was high, we preferred a percutaneous approach and extracted the entrapped balloon with high traction force under rapid pacing after valve stabilization with another balloon, which was placed in the annular position.

Prognostic value of impaired hepato-renal function assessed by the MELD-XI score in patients undergoing percutaneous mitral valve repair.

OBJECTIVES: The objective of this study was to assess the prognostic value of the Model for End-stage Liver Disease (MELD)-XI score in patients undergoing PMVR with the MitraClip system. BACKGROUND: MELD-XI score, which was originally developed for prognostic assessment in patients with advanced liver disease, has been reported as a predictor of outcome in heart failure patients. METHODS: A total of 192 consecutive patients undergoing percutaneous mitral valve repair (PMVR) were included into final analysis. MELD-XI score was calculated on the day of the procedure and patients were categorized into three groups based on MELD-XI score and compared with regards to clinical characteristics and outcomes following PMVR. RESULTS: MELD-XI > 12 was associated with male gender, higher logistic EuroSCORE, reduced left ventricular ejection fraction, enlarged right ventricular end-diastolic diameter, degree of mitral regurgitation, increased NT-proBNP serum levels and elevated right atrial pressures. Youden-Index revealed a cutoff of 16 in the MELD-XI score as best predictor of one-year all-cause mortality. Kaplan-Meier analysis and the log-rank test confirmed increased one-year mortality in patients with critically high score above 16 (mortality MELD-XI score > 16 vs 16-12 vs <12:39% vs 9%. vs 15%; P = 0.005). Compared to patients with lower MELD-XI score, these patients exhibited a more than 3-fold increased one-year mortality after PMVR. CONCLUSION: Given the high mortality in patients with a MELD-XI score > 16, these patients require a high-risk preoperative assessment and should undergo a careful discussion within the heart team for the best treatment option given the considerable one-year mortality following PMVR.

Stent fractures after common femoral artery bail-out stenting due to suture device failure in TAVR.

BACKGROUND: Vascular access site-related complications are frequent in the context of transfemoral transcatheter aortic valve replacement (TAVR). The implantation of a covered stent graft is an effective treatment option for bleeding control. However, the external iliac and common femoral arteries are exposed to flexion of the hip joint. Therefore, stent compression and stent/strut fractures may occur, facilitating stent occlusion. PATIENTS AND METHODS: In all 389 patients who received transfemoral TAVR from 2013-2015 at the Düsseldorf Heart Centre, we monitored the management of vascular access site-related complications. Our analyses focused on immediate technical success and bleeding control, primary patency, and the occurrence of stent/strut fractures after six to 12 months of follow-up. RESULTS: Vascular access site-related complications occurred in 13 % (n = 51), whereof in 10 patients, the bleeding was successfully managed by prolonged compression. In 40 out of 51 patients, a covered stent graft was implanted in the common femoral artery, leading to 100 % immediate bleeding control. After a mean follow-up of 334 ± 188 days, 28 stents out of 29 patients with completed follow-up (excluding e. g. death) were without flow-limiting stenosis (primary patency 97 %) or relevant stent compression (diameter pre/post 8.6/8.1 mm, p = 0.048, late lumen loss 1.1 ± 0.2 mm, mean flow velocity 92 ± 34 cm/s). In four asymptomatic patients, stent/strut fractures were detected (14 %) without flow-limiting stenosis. CONCLUSIONS: The implantation of a covered stent graft is highly effective and safe to control vascular access site-related complications after TAVR. Stent/strut fractures in the flexible segment of the common femoral artery may occur, as consequently verified by X-ray visualization, but show no impairment on flow or clinical parameters after six to 12 months.

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.

Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair.

BACKGROUND: Mitral regurgitation causes left atrial (LA) and left ventricular (LV) dysfunction, dilatation, and remodeling. Following percutaneous mitral valve repair (PMVR) using the MitraClip® approach, reverse cardiac remodeling is desirable. To date, the influence of PMVR on LA and segmental LV function and remodeling has not been investigated in detail. METHODS: Twenty-six patients who received the MitraClip device were enrolled in an open-label, single-center observational study. Patients underwent clinical assessment, conventional echocardiography and global and segmental longitudinal strain analysis of the left atrium and left ventricle by speckle tracking echocardiography at baseline and at a three-month follow up. RESULTS: PMVR improved both LV systolic function (from 40.5 ± 2.5% to 45.0 ± 2.5%, p = 0.04) and LV global longitudinal strain (from -8.9 ± 0.7% to -10.7 ± 0.9%, p = 0.004). Segmental analysis revealed improved myocardial deformation mainly in the basal (basalseptal -8.9 ± 0.8% to -12.9 ± 0.8%, p = 0.0002; basallateral -7.9 ± 1.1% to -13.9 ± 1.4%, p = 0.0005) and midventricular segments (mid-septal -12.7 ± 0.9% to -14.5 ± 1.1%, p = 0.02; mid-lateral -7.5 ± 0.8% to -10.8 ± 1.2%, p = 0.006). In patients with pre-procedural preserved LA function with sinus rhythm the impact of PMVR revealed an improvement in LA global conduit function (from 10.6 ± 1.2% to 13.9 ± 1.6%, p = 0.003) and global contractile function (from -2.1 ± 0.47% to -3.5 ± 0.5%, p = 0.03). The reversed remodeling was not associated with altered levels of the cardiac biomarkers matrix metalloproteinase 2 (MMP-2) and MMP-9, tissue-inhibitors of MMPs (TIMP-2 and ST-2). CONCLUSIONS: PMVR improves global segmental LV and LA function and leads to a reverse remodeling.

Influence of percutaneous mitral valve repair using the MitraClip® system on renal function in patients with severe mitral regurgitation.

BACKGROUND: In patients with mitral regurgitation (MR), changes in cardiac stroke volume, and thus renal preload and afterload may affect kidney function. Percutaneous mitral valve repair (PMVR) with the MitraClip® system can be a therapeutic alternative to surgical valve repair. The influence of MitraClip® therapy on renal function and clinical outcome parameters is unknown. METHODS AND RESULTS: Sixty patients with severe MR underwent PMVR using the MitraClip® system in an open-label observational study. Patients were stratified according to their renal function. All clips have been implanted successfully. Effective reduction of MR by 2-3 grades acutely improved KDOQI class. Lesser MR reduction (MR reduction of 0-1 grades) led to worsening of renal function in patients with pre-existing normal or mild (KDOQI 1-2) compared to severe (KDOQI 3-4) renal dysfunction. Reduction of MR was associated with improvement in Minnesota Living with Heart Failure Questionnaire (MLHFQ), NYHA-stadium, and 6-minute walk test. CONCLUSION: Successful PMVR was associated with an improvement in renal function. The improvement in renal function was associated with the extent of MR reduction and pre-existing kidney dysfunction. Our data emphasize the relevance of PVMR to stabilize the cardiorenal axis in patients with severe MR.

Baseline HV-interval predicts complete AV-block secondary to transcatheter aortic valve implantation.

PURPOSE: Development of AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). To date little is known about the predictive value of the HV-interval prior to TAVI with respect to the risk of AV-block development. METHODS AND RESULTS: HV-interval was determined in 25 consecutive elderly patients with severe aortic valve stenosis (AS) before and immediately after TAVI. All patients subsequently underwent TAVI and 8 of these 25 patients (32%) developed complete AV-block during the TAVI procedure requiring permanent pacemaker implantation. Six of these 8 patients (75%) had marked HV prolongation (>54 ms). Pre-procedural HV-interval was significantly prolonged in the subgroup developing complete AV-block (62.1 ms±13.0 vs 49.2 ms±12.9; P=0.029). Prolongation of the HV-interval above 54 ms was associated with a higher rate of complete AV-block (sensitivity 75.0%, specificity 77.8%, P=0.01). CONCLUSIONS: HV-interval was prolonged in approximately one third of our elderly patients with aortic valve stenosis and associated with a high rate of complete AV-block following TAVI. HV-interval is easily obtained during TAVI screening procedures, thus facilitating identification of patients at risk for complete AV-block due to TAVI and consequently enabling bespoke risk management.

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.

Iatrogenic atrial septal defect persistence after percutaneous mitral valve repair: a meta-analysis.

BACKGROUND: Percutaneous mitral valve repair (PMVR) requires a puncture of the atrial septum, resulting in iatrogenic atrial septal defect (iASD), which usually causes a transient left-to-right shunt. However, the influencing risk factors for iASD persistence and functional consequences are not fully understood. This meta-analysis aimed to summarise available data on the persistence of iASD following PMVR. METHODS: The authors conducted a literature search in PubMed/MEDLINE and EMBASE databases to identify studies investigating iASD persistence in PMVR patients. RESULTS: Six observational studies (n = 361) met inclusion criteria for the final analysis. Prevalence of persistent iASD was documented with 28% after 12 months follow-up. iASD size increased over time with a diameter of 5.3 ± 0.76 mm after one month and 6.5 ± 0.21 mm after 12 months. Possible predictors of iASD persistence after PMVR appeared to be pre-existing AF (RR 1.24; p = .03), residual mitral regurgitation > II° (RR 2.06; p = .03) and prolonged fluoroscopic time (RR 8.27; p = .01). Patients with iASD persistence had a higher risk for development of right heart overload regarding the increased area of the right atrium (MD 5.24; p = .004) and enlarged diameter of the right ventricle (MD 3.33; p < .0001). Rehospitalization was more frequently reported in iASD patients (RR 9.52; p = .004). CONCLUSIONS: This meta-analysis proved iASD persistence in 28% of PMVR after 12 months follow-up with a higher risk for right heart volume overload and more frequent rehospitalization compared to patients without iASD persistence. Since percutaneous catheter-based treatments with transseptal approaches are rising, further evidence about the hemodynamic impact of persistent iASD is warranted.

Multi-Slice Computed Tomography Analysis in Patients Undergoing Transcatheter Aortic Valve Replacement - Impact of Workflows on Measurement of Virtual Aortic Annulus and Valve Size.

Exact and reliable measurements of anatomical dimensions in pre-procedural multi-slice computed tomography (MSCT) scans are crucial for optimal valve sizing and clinical results of transcatheter aortic valve replacement (TAVR). This study aimed to investigate interrater reliability between routinely used workflows for pre-procedural analysis. MSCT scans of 329 patients scheduled for TAVR were analyzed using both a 3mensio and SECTRA IDS7 platform. The results were retrospectively compared using the intraclass correlation coefficient, revealing excellent correlation in the analysis of simple diameters and poor correlation in the assessment of more complex structures with impact on calculated valve size.

Safety of transoesophageal echocardiography during structural heart disease interventions under procedural sedation: a single-centre study.

AIMS: The aim of this study was to determine the incidence of transoesophageal echocardiography (TOE)-related adverse events (AEs) during structural heart disease (SHD) interventions and to identify potential risk factors. METHODS AND RESULTS: We retrospectively analysed 898 consecutive patients undergoing TOE-guided SHD interventions under procedural sedation. TOE-related AEs were classified as bleeding complications, mechanical lesions, conversion to general anaesthesia with intubation, and the occurrence of pneumonia. A follow-up was conducted up to 3 months after the intervention. TOE-related AEs were observed in 5.3% of the patients (n = 48). The highest rate of AEs was observed in the percutaneous mitral valve repair (PMVR) group with 8.2% (n = 32), whereas 4.8% (n = 11) of the patients in the left atrial appendage group and 1.8% (n = 5) in the patent foramen ovale/atrial septal defect group developed a TOE-related AE (P = 0.001). The most frequent AE was pneumonia with an incidence of 2.6% (n = 26) in the total cohort. Bleeding events occurred in 1.8% (n = 16) of the patients, mostly in the PMVR group with 2.1% (n = 8). In the multivariate regression analysis, we found a lower haemoglobin {odds ratio (OR) [95% confidence interval (CI)]: 8.82 (0.68-0.98) P = 0.025} and an obstructive sleep apnoea syndrome (OSAS) [OR (95% CI): 2.51 (1.08-5.84) P = 0.033] to be associated with AE. Furthermore, AEs were related to procedural time [OR (95% CI): 1.01 (1.0-1.01) P = 0.056] and oral anticoagulation [OR (95% CI): 1.97 (0.9-4.3) P = 0.076] with borderline significance in the multivariate regression analysis. No persistent damages were observed. CONCLUSION: TOE-related AEs during SHD interventions are clinically relevant. It was highest in patients undergoing PMVR. A lower baseline haemoglobin level and an OSAS were found to be associated with the occurrence of a TOE-related AE.

Real-time echocardiography-fluoroscopy fusion imaging for left atrial appendage closure: prime time for fusion imaging?

BACKGROUND: Real-time echocardiography-fluoroscopy fusion imaging (FI) merges real-time echocardiographic imaging with fluoroscopic images allowing intuitive anatomical spatial orientation during structural heart disease interventions. We aimed to assess the safety and efficacy of FI during percutaneous left atrial appendage closure (LAAC). METHODS: 34 consecutive patients before (-FI) and 121 patients after (+FI) the introduction of FI for LAAC were included in a single-centre study. In-hospital safety parameters were analysed according to adverse event (AE) definition of the Munich consensus document and procedure-related parameters were assessed for efficacy. An ANCOVA was performed to investigate the influence of a learning curve. RESULTS: Time until successful transseptal puncture was significantly reduced as well as total procedure time and the amount of contrast agent used (+FI/-FI:17 ± 6.35 min vs. 22 ± 8.33 min, p = 0.001; +FI/-FI: 50 min IQR 43 min - 60 min vs. 57 min IQR 45 min -70 min; p = 0.013; +FI/-FI: 70 mL, IQR 55 ml-90 mL vs. 152 mL, IQR 107 mL - 205 mL; p < 0.001). However, fluoroscopy time and dose-area product did not differ between both groups. There was no significant difference in the occurrence of in-hospital adverse events (+FI/-FI: 2.5% vs. 0%; p = 0.596). The ANCOVA revealed that the learning curve does not affect procedural efficacy parameters such as procedure time, time to transseptal puncture, amount of contrast agent and dose-area product. CONCLUSIONS: FI for LAAC reduces the total procedure time, the time to successful transseptal puncture and periprocedural amount of contrast agent.

Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study.

OBJECTIVE: To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS). BACKGROUND: Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO. METHODS: Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared. RESULTS: Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p<0.001), total amount of contrast medium (GA: 105±81 mL vs CS: 86±66 mL, p<0.001) and fluoroscopic time (GA: 13±9 min vs CS: 12±13 min, p<0.001) were less in CS cases. Procedure-related or device-related serious adverse events during the first 7 days were numerically higher in the CS group (GA: 4.9% vs CS: 7.6%, p=0.114). Peridevice residual flow was absent or ≤5 mm 1-3 months after the procedure in 99.7% of the GA and in 100% of the CS group (p=1.000). CONCLUSIONS: In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases. TRIAL REGISTRATION NUMBER: NCT02447081; Results.

Short- and Mid-Term Outcomes in Patients Deemed Inoperable Undergoing Transapical and Transfemoral TAVR with an STS-PROM below Four Percent.

Transapical (TA) TAVR is known to be associated with increased mortality and vascular complications compared with transfemoral (TF) TAVR in high-risk and inoperable patients. However, safe alternative access methods remain crucial. We aimed to (1) evaluate the 30-day and 1-year outcomes comparing TA and TF TAVR in patients with an STS-PROM of <4% deemed inoperable and (2) determine dependent and independent predictors for all-cause one-year mortality. Data were collected from a single-center registry consisting of 340 eligible patients. One-to-one propensity score matching was performed (n = 50 TA, n = 50 TF). Primary endpoints were all-cause mortality, stroke, and major bleeding. Predictors for all-cause one-year mortality were evaluated. Thirty-day mortality (TF vs. TA: 0.0% vs. 4.0%; p = 0.153) was comparable in both cohorts. One-year all-cause mortality was twice as high in TA patients (TF vs. TA: 10.0% vs. 20.0%, p logrank = 0.165, HR 2.10). Cerebrovascular events and major bleeding during one-year follow-up were similar. The multivariate analysis identified hemoglobin <12 g/dL at admission and dual antiplatelet therapy as strong predictors for one-year mortality. Although femoral access is the primary access with favorable 30-day and 1-year results, transapical access was successful for patients unsuitable for TF TAVR, showing acceptable short- and mid-term results in inoperable patients with low-risk profiles.