Cusp-overlap view reduces conduction disturbances and permanent pacemaker implantation after transcatheter aortic valve replacement even with balloon-expandable and mechanically-expandable heart valves.

Background: Conduction disturbances demanding permanent pacemaker implantation (PPI) remain a common complication after transcatheter aortic valve replacement (TAVR). Optimization of the implantation depth (ID) by introducing the cusp-overlap projection (COP) technique led to a reduced rate of PPI when self-expanding valves were used. Objectives: The aim of the present study was to determine if using the novel COP view is applicable for all types of TAVR prosthesis and results in a higher ID and reduced incidence of new conduction disturbances and PPI. Methods: In this prospective case-control study 586 consecutive patients undergoing TAVR with either balloon-expandable Edwards SAPIEN S3 (n = 280; 47.8%), or mechanically expandable Boston LOTUS Edge heart valve prostheses (n = 306; 52.2%) were included. ID as well as rates of periprocedural PPI and left bundle branch block (LBBB) were compared between the conventional three-cusp coplanar (TCC) projection and the COP view for implantation. Results: Of 586 patients, 282 (48.1%) underwent TAVR using COP, whereas in 304 patients (51.9%) the TCC view was applied. Using COP a significantly higher ID was achieved in Edwards SAPIEN S3 TAVR procedures (ID mean difference -1.0 mm, 95%-CI -1.9 to -0.1 mm; P = 0.029), whereas the final platform position did not differ significantly between both techniques when a Boston LOTUS Edge valve was used (ID mean difference -0.1 mm, 95%-CI -1.1 to +0.9 mm; P = 0.890). In Edwards SAPIEN S3 valves, higher ID was associated with a numerically lower post-procedural PPI incidence (4.9% vs. 7.3%; P = 0.464). Moreover, ID was significantly deeper in patients requiring PPI post TAVR compared to those without PPI [8.7 mm (6.8-10.6 mm) vs. 6.5 mm (6.1-7.0 mm); P = 0.005]. In Boston LOTUS Edge devices, COP view significantly decreased the incidence of LBBB post procedure (28.1% vs. 47.9%; P < 0.001), while PPI rates were similar in both groups (21.6% vs. 25.7%; P = 0.396). Conclusion: The present study demonstrates the safety, efficacy and reproducibility of the cusp-overlap view even in balloon-expandable and mechanically-expandable TAVR procedures. Application of COP leads to significantly less LBBB in repositionable Boston LOTUS Edge valves and a numerically lower PPI rate in Edwards SAPIEN S3 valves post TAVR compared to the standard TCC projection. The results should encourage to apply the COP view more widely in clinical practice.

Drug-coated balloon: an effective alternative to stent strategy in small-vessel coronary artery disease-a meta-analysis.

Background: Small-vessel coronary artery disease (CAD) is frequently observed in coronary angiography and linked to a higher risk of lesion failure and restenosis. Currently, treatment of small vessels is not standardized while having drug-eluting stents (DES) or drug-coated balloons (DCBs) as possible strategies. We aimed to conduct a meta-analytic approach to assess the effectiveness of treatment strategies and outcomes for small-vessel CAD. Methods: Comprehensive literature search was conducted using PubMed, Embase, MEDLINE, and Cochrane Library databases to identify studies reporting treatment strategies of small-vessel CAD with a reference diameter of ≤3.0 mm. Target lesion revascularization (TLR), target lesion thrombosis, all-cause death, myocardial infarction (MI), and major adverse cardiac events (MACE) were defined as clinical outcomes. Outcomes from single-arm and randomized studies based on measures by means of their corresponding 95% confidence intervals (CI) were compared using a meta-analytic approach. Statistical significance was assumed if CIs did not overlap. Results: Thirty-seven eligible studies with a total of 31,835 patients with small-vessel CAD were included in the present analysis. Among those, 28,147 patients were treated with DES (24 studies) and 3,299 patients with DCB (18 studies). Common baseline characteristics were equally distributed in the different studies. TLR rate was 4% in both treatment strategies [0.04; 95% CI 0.03-0.05 (DES) vs. 0.03-0.07 (DCB)]. MI occurred in 3% of patients receiving DES and in 2% treated with DCB [0.03 (0.02-0.04) vs. 0.02 (0.01-0.03)]. All-cause mortality was 3% in the DES group [0.03 (0.02-0.05)] compared with 1% in the DCB group [0.01 (0.00-0.03)]. Approximately 9% of patients with DES developed MACE vs. 4% of patients with DCB [0.09 (0.07-0.10) vs. 0.04 (0.02-0.08)]. Meta-regression analysis did not show a significant impact of reference vessel diameter on outcomes. Conclusion: This large meta-analytic approach demonstrates similar clinical and angiographic results between treatment strategies with DES and DCB in small-vessel CAD. Therefore, DES may be waived in small coronary arteries when PCI is performed with DCB.

Cardiac magnetic resonance imaging for preprocedural planning of percutaneous left atrial appendage closure.

Introduction: Percutaneous closure of the left atrial appendage (LAA) facilitates stroke prevention in patients with atrial fibrillation. Optimal device selection and positioning are often challenging due to highly variable LAA shape and dimension and thus require accurate assessment of the respective anatomy. Transesophageal echocardiography (TEE) and x-ray fluoroscopy (XR) represent the gold standard imaging techniques. However, device underestimation has frequently been observed. Assessment based on 3-dimensional computer tomography (CTA) has been reported as more accurate but increases radiation and contrast agent burden. In this study, the use of non-contrast-enhanced cardiac magnetic resonance imaging (CMR) to support preprocedural planning for LAA closure (LAAc) was investigated. Methods: CMR was performed in thirteen patients prior to LAAc. Based on the 3-dimensional CMR image data, the dimensions of the LAA were quantified and optimal C-arm angulations were determined and compared to periprocedural data. Quantitative figures used for evaluation of the technique comprised the maximum diameter, the diameter derived from perimeter and the area of the landing zone of the LAA. Results: Perimeter- and area-based diameters derived from preprocedural CMR showed excellent congruency compared to those measured periprocedurally by XR, whereas the respective maximum diameter resulted in significant overestimation (p < 0.05). Compared to TEE assessment, CMR-derived diameters resulted in significantly larger dimensions (p < 0.05). The deviation of the maximum diameter to the diameters measured by XR and TEE correlated well with the ovality of the LAA. C-arm angulations used during the procedures were in agreement with those determined by CMR in case of circular LAA. Discussion: This small pilot study demonstrates the potential of non-contrast-enhanced CMR to support preprocedural planning of LAAc. Diameter measurements based on LAA area and perimeter correlated well with the actual device selection parameters. CMR-derived determination of landing zones facilitated accurate C-arm angulation for optimal device positioning.

Computed tomography angiography/magnetic resonance imaging-based preprocedural planning and guidance in the interventional treatment of structural heart disease.

Preprocedural planning and periprocedural guidance based on image fusion are widely established techniques supporting the interventional treatment of structural heart disease. However, these two techniques are typically used independently. Previous works have already demonstrated the benefits of integrating planning details into image fusion but are limited to a few applications and the availability of the proprietary tools used. We propose a vendor-independent approach to integrate planning details into periprocedural image fusion facilitating guidance during interventional treatment. In this work, we demonstrate the feasibility of integrating planning details derived from computer tomography and magnetic resonance imaging into periprocedural image fusion with open-source and commercially established tools. The integration of preprocedural planning details into periprocedural image fusion has the potential to support safe and efficient interventional treatment of structural heart disease.

Case Report: Myocarditis After COVID-19 Vaccination - Case Series and Literature Review.

BACKGROUND: The ongoing COVID-19 pandemic demands a series of measures and, above all, the vaccination of a substantial proportion of the population. Acute myocarditis is a rare complication of the widely used mRNA-based vaccines. CASE PRESENTATION: We present a case series of four patients (three men and one woman, 16 to 47 years old) with acute pericarditis/myocarditis 3 to 17 days after mRNA vaccination. They presented with chest pain, fever, and flu-like symptoms. Diagnosis was made based on the synopsis of clinical presentation, elevated levels of troponin T and NT-proBNP, impaired systolic function on echocardiography, and findings in non-invasive tissue characterization by cardiovascular magnetic resonance imaging. Two patients also underwent endomyocardial biopsies. As none of the patients showed signs of cardiogenic shock, they were discharged from ward care only a few days after their initial presentations. CONCLUSIONS: Our data are consistent with other case reports of myocarditis early after mRNA vaccination and demonstrate the need for multimodal diagnostics. In view of its rarity and mild course, the risk-benefit ratio of vaccination remains positive compared to potential SARS-CoV-2 infection.

Vascular Access-Site Choice and Outcomes in Patients With Previous Coronary Artery Bypass Surgery Undergoing Coronary Catheterization in a High-Volume Transradial Center.

BACKGROUND: Transradial access for coronary angiography was observed to be superior to femoral access. Nevertheless, femoral artery access is still frequently used, especially in challenging subgroups with high procedural complexity, like patients with previous coronary artery bypass grafting (CABG). PURPOSE: We analyzed access-site choice and outcomes of CABG patients undergoing coronary catheterization in different clinical settings. METHODS: A total of 1206 consecutive CABG patients undergoing coronary angiography and intervention were included in this study. Procedural and clinical outcomes were compared between transradial and transfemoral access. Multivariate logistic regression analysis was performed to identify predictors of access-site choice. RESULTS: Coronary catheterization was performed via radial access in 753 patients (63.1%) and via femoral access in 442 patients (36.9%). During the study period, femoral artery utilization dropped from 55.2% to a minimum of 28.2% per year (P<.01). Short stature (odds ratio [OR], 1.62; P<.01), peripheral artery disease (OR, 1.42; P=.04), cardiopulmonary resuscitation (CPR) (OR, 4.17; P<.001), ST-segment elevation myocardial infarction (STEMI) (OR, 2.56; P=.01), and coexisting left and right internal mammary artery (LIMA/RIMA) bypass grafts (OR, 2.67; P<.001) were independently associated with femoral access-site choice. Study outcomes including access-site complications (4.3% vs 1.6%; P<.01) as well as short- and long-term mortality (30-day mortality: 6.8% vs 2.0%; hazard ratio, 3.52; 95% confidence interval, 1.84-6.70; P<.001) were more likely to occur with femoral access. Length of stay was shorter in the radial cohort (3.7 ± 5.1 days vs 5.3 ± 7.2 days; P<.001). CONCLUSION: Radial access appears to be favorable even in complex CABG patients. Although radial access was set as the standard vascular approach, femoral access was chosen in one-third of all patients. Independent predictors for femoral access were short stature, peripheral artery disease, acute settings like CPR and STEMI, as well as coexisting LIMA and RIMA grafts.

Imaging Challenges in Patients with Severe Aortic Stenosis and Heart Failure: Did We Find a Way Out of the Labyrinth?

Aortic stenosis (AS) is the most frequent degenerative valvular disease in developed countries. Its incidence has been constantly rising due to population aging. The diagnosis of AS was considered straightforward for a very long time. High gradients and reduced aortic valve area were considered as "sine qua non" in diagnosis of AS until a growing body of evidence showed that patients with low gradients could also have severe AS with the same or even worse outcome. This completely changed the paradigm of AS diagnosis and involved large numbers of parameters that had never been used in the evaluation of AS severity. Low gradient AS patients may present with heart failure (HF) with preserved or reduced left ventricular ejection fraction (LVEF), associated with changes in cardiac output and flow across the aortic valve. These patients with low-flow low-gradient or paradoxical low-flow low-gradient AS are particularly challenging to diagnose, and cardiac output and flow across the aortic valve have become the most relevant parameters in evaluation of AS, besides gradients and aortic valve area. The introduction of other imaging modalities in the diagnosis of AS significantly improved our knowledge about cardiac mechanics, tissue characterization of myocardium, calcium and inflammation burden of the aortic valve, and their impact on severity, progression and prognosis of AS, not only in symptomatic but also in asymptomatic patients. However, a variety of novel parameters also brought uncertainty regarding the clinical relevance of these indices, as well as the necessity for their validation in everyday practice. The aim of this review is to summarize the prevalence of HF in patients with severe AS and elaborate on the diagnostic challenges and advantages of comprehensive multimodality cardiac imaging to identify the patients that may benefit from surgical or transcatheter aortic valve replacement, as well as parameters that may help during follow-up.

Vascular Access Site Complications Do Not Correlate With Large Sheath Diameter in TAVI Procedures With New Generation Devices.

Background: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) are associated with morbidity and mortality. However, consistent predictors have not been identified yet. The size of the implantation sheath seems to play a role, though especially with new generation TAVI devices and their improved sheaths and delivery systems this remains uncertain. Objectives: This study aimed to determine the incidence and predictors of access site-related vascular complications (VC) in the era of new generation TAVI devices. Methods and Results: Four hundred consecutive patients receiving TAVI in an experienced tertiary care center were analyzed. VC occurred in 89 patients (22.25%) with the majority being minor VC (21%) and only 1.25% major VC. Possible predictors for VC were tested, and only peri-interventional dual antiplatelet therapy (DAPT) showed to be predictive for VC [OR 2.11 (95% CI 1.10-4.06, p = 0.025)]. The female gender [OR 0.75 (95% CI 0.44-1.3), p = 0.31], sheath to femoral artery ratio >1.05 [OR 1.18 (95% CI 0.66-2.08, p = 0.58)], calcification of the access site vessel [OR 0.83 (95% CI 0.48-1.42, p = 0.48)], known peripheral artery disease [OR 0.95 (95% CI 0.4-2.25, p = 0.9)], and BMI ≥ 25 kg/m2 [OR 0.69 (95% CI 0.41-1.19, p = 0-19)] were not predictive of VC. The larger sheath with 20 French even showed less VC than the smaller sheath with 16 French [OR 0.43 (95% CI 0.25-0.74, p = 0.002)]. Conclusions: Overall, the rate of major and minor VC was low in this study population (for major VC: rate of 1.25%). Predefined risk factors were not associated with the occurrence of VC, except for peri-interventional treatment with DAPT. Especially, larger sheath size could not be identified as a predictor for VC in the setting of TAVI procedures performed with contemporary devices.

Impact of extent of coronary artery disease and percutaneous revascularization assessed by the SYNTAX score on outcomes following transcatheter aortic valve replacement.

OBJECTIVES: The aim of the study was to analyze the impact of concomitant coronary artery disease (CAD) assessed by the SYNTAX score (SS) and periprocedural percutaneous coronary intervention (PCI) on outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND: Due to controversial data regarding the effect of CAD on outcomes after TAVR, proper revascularization strategies remain a matter of debate. METHODS: 553 patients with severe aortic stenosis undergoing TAVR were included in this study. SS was calculated for each patient at baseline and after PCI. Primary outcome was one-year all-cause mortality. RESULTS: 60.2% of patients (N = 333) exhibited CAD with a mean SS of 10.8 ± 8.8. Of those, 120 patients (36.0%) received periprocedural PCI. In the treatment group, mean SS was decreased from 14.9 ± 9.1 to 6.3 ± 6.7. Patients with concomitant CAD suffered more frequently from myocardial infarction (MI) post TAVR compared to those without CAD (2.1% vs. 0.0%; P < 0.01). In the CAD cohort, MI rates were comparable between patients with and without PCI (2.2% vs. 2.5%; P = 0.71). Regarding SS, patients with a residual SS < 8 showed significant lower rates of one-year mortality (9.0% vs. 18.2%; P = 0.016) and MACCE (16.5% vs. 32.2%; P = 0.001). Besides left bundle brunch, predictors for an increased one-year mortality were a residual SS ≥ 8 in the CAD group (OR = 3.17; P = 0.011) and a EuroSCORE ≥ 4% in the entire study population (OR = 2.18; P = 0.017). CONCLUSION: Our results suggest that a residual SS-guided revascularization strategy may improve prognosis after TAVR in patients with concomitant CAD. PCI aiming for a residual SS < 8 was associated with improved one-year clinical outcomes.

The Predictive Value of Right Ventricular Longitudinal Strain in Pulmonary Hypertension, Heart Failure, and Valvular Diseases.

Right ventricular (RV) systolic function has an important role in the prediction of adverse outcomes, including mortality, in a wide range of cardiovascular (CV) conditions. Because of complex RV geometry and load dependency of the RV functional parameters, conventional echocardiographic parameters such as RV fractional area change (FAC) and tricuspid annular plane systolic excursion (TAPSE), have limited prognostic power in a large number of patients. RV longitudinal strain overcame the majority of these limitations, as it is angle-independent, less load-dependent, highly reproducible, and measure regional myocardial deformation. It has a high predictive value in patients with pulmonary hypertension, heart failure, congenital heart disease, ischemic heart disease, pulmonary embolism, cardiomyopathies, and valvular disease. It enables detection of subclinical RV damage even when conventional parameters of RV systolic function are in the normal range. Even though cardiac magnetic resonance-derived RV longitudinal strain showed excellent predictive value, echocardiography-derived RV strain remains the method of choice for evaluation of RV mechanics primarily due to high availability. Despite a constantly growing body of evidence that support RV longitudinal strain evaluation in the majority of CV patients, its assessment has not become the part of the routine echocardiographic examination in the majority of echocardiographic laboratories. The aim of this clinical review was to summarize the current data about the predictive value of RV longitudinal strain in patients with pulmonary hypertension, heart failure and valvular heart diseases.

The Prognostic Importance of Right Ventricular Longitudinal Strain in Patients with Cardiomyopathies, Connective Tissue Diseases, Coronary Artery Disease, and Congenital Heart Diseases.

Right ventricular (RV) systolic function represents an important independent predictor of adverse outcomes in many cardiovascular (CV) diseases. However, conventional parameters of RV systolic function (tricuspid annular plane excursion (TAPSE), RV myocardial performance index (MPI), and fractional area change (FAC)) are not always able to detect subtle changes in RV function. New evidence indicates a significantly higher predictive value of RV longitudinal strain (LS) over conventional parameters. RVLS showed higher sensitivity and specificity in the detection of RV dysfunction in the absence of RV dilatation, apparent wall motion abnormalities, and reduced global RV systolic function. Additionally, RVLS represents a significant and independent predictor of adverse outcomes in patients with dilated cardiomyopathy (CMP), hypertrophic CMP, arrhythmogenic RV CMP, and amyloidosis, but also in patients with connective tissue diseases and patients with coronary artery disease. Due to its availability, echocardiography remains the main imaging tool for RVLS assessment, but cardiac magnetic resonance (CMR) also represents an important additional imaging tool in RVLG assessment. The findings from the large studies support the routine evaluation of RVLS in the majority of CV patients, but this has still not been adopted in daily clinical practice. This clinical review aims to summarize the significance and predictive value of RVLS in patients with different types of cardiomyopathies, tissue connective diseases, and coronary artery disease.

Long-term clinical outcome of persistent left bundle branch block after transfemoral aortic valve implantation.

OBJECTIVE: The impact of persistent left bundle-branch block (pLBBB) on long-term clinical outcome remains to be determined. BACKGROUND: New-onset of pLBBB occurs frequently after transfemoral aortic valve implantation (TAVI). METHODS: Seven hundred and seven consecutive patients who underwent TAVI were analyzed for baseline and procedural characteristics and clinical outcome in an up to 2-year follow-up. Patients were divided into either a group with pLBBB until hospital discharge or a group without LBBB. We performed propensity-score matching and analyzed baseline characteristics, procedural data and clinical outcome of both groups. Patients received balloon-expandable valves in 56.4%, mechanically expandable valves in 37.5%, and self-expandable valves in 6.3%. RESULTS: A new-onset, pLBBB was observed in 47.5% of patients after TAVI. The implantation of a mechanically expandable valve was associated with higher rate of pLBBB (54.2% vs. 20.8%, P < 0.001), whereas implantation of a balloon-expandable valve was associated with lower incidence of pLBBB (39.8% vs. 73.1%, P < 0.001). Deeper ventricular implantation at left-coronary side led to higher rates of pLBBB (7.5 ± 2.5 vs. 6.7 ± 2.6 mm, P < 0.001). The occurrence of pLBBB was associated with higher rates of permanent pacemaker implantation (40.9% vs. 15.9%, P < 0.001). By multivariate analysis, implantation of a mechanically expandable valve (Boston Scientific Lotus valve) was identified as independent predictor of occurrence of pLBBB (odds ratio 4.7, confidence interval 3.2-7.0, P < 0.001). In the 2-year follow-up, there were no significant differences between "pLBBB" and "no LBBB"-groups regarding mortality and rehospitalization due to heart failure. CONCLUSIONS: The occurrence of pLBBB is associated with the choice of valve type and implantation depth and requires significantly higher rates of permanent pacemaker implantations. Importantly, there are no differences in the 2-year follow-up regarding mortality and rehospitalization due to heart failure.

Significant Differences in Debris Captured by the Sentinel Dual-Filter Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Among Different Valve Types.

OBJECTIVES: The aim of this study was to evaluate the debris captured by the Claret Sentinel cerebral embolic dual-filter protection device during transfemoral transcatheter aortic valve replacement (TAVR) with different valve types. BACKGROUND: Risk for embolization of debris during TAVR may vary by TAVR device. METHODS: The filters of 100 consecutive patients were collected and captured debris was analyzed by histopathology and histomorphometry. Three valve types were implanted: the balloon-expandable Edwards SAPIEN 3 (n = 42), the self-expandable Medtronic Evolut R (n = 35), and the mechanically implantable Boston Scientific Lotus (n = 23). RESULTS: Among the 3 groups there was no difference in baseline data, including Society of Thoracic Surgeons score for mortality, calcification, or pre-dilation. The type of captured debris did not differ among the 3 valve types in the proximal or distal filter. With the balloon-expandable valve, there were significantly more patients with large debris measuring ≥1,000 µm. The number of particles in the proximal filter was significantly lower with the Lotus (89.8 ± 106.3) compared with the Evolut R (187.3 ± 176.9) and Edwards SAPIEN 3 (172.3 ± 133.5) valves (p = 0.035). Total tissue area in the proximal filter was significantly smaller for the Lotus compared with the other 2 valve types (7.1 ± 6.3, 20.1 ± 19.0, and 21.3 ± 15.1 mm2; p = 0.0014). In contrast, for the distal filter, there were no differences with respect to valve type for total tissue area, particle size, and number of particles. CONCLUSIONS: A significant difference was observed in the size and number of captured tissue particles with the double-filter embolic protection device among different valve types in patients undergoing TAVR. The largest particles were observed in patients treated with a balloon-expandable valve.

Improved Registration of 3D CT Angiography with X-ray Fluoroscopy for Image Fusion During Transcatheter Aortic Valve Implantation.

The fusion of 3D anatomical models derived from high-fidelity pre-interventional computed tomography angiography (CTA), and x-ray (XR) fluoroscopy to facilitate anatomical guidance is of huge interest for complex cardiac interventions like TAVI procedures with cerebral protection. Co-registration of CTA and XR has been introduced either based on additional intraoperative non-/contrast-enhanced cone-beam computed tomography (CBCT) or two separate aortograms. With the related increase of radiation exposure and/or contrast agent (CA) dose, a potential additional risk for the patient is introduced. Here, we propose a modified co-registration approach making use of arteriograms of the iliofemoral arteries, routinely performed during the femoral puncture and sheath introduction. On-the-fly refinement of the co-registration during the on-going procedure enables accurate co-registration without any additional angiograms, thus reducing CA, XR dose and procedure time, while simultaneously improving operator confidence and procedure safety.

New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome.

New generation devices for transcatheter aortic valve replacement have been optimized to improve clinical outcome. We compared procedural, in-hospital, 30 days and 12 months outcome of the new generation repositionable Boston Lotus Valve and the balloon-expandable Edwards Sapien 3 valve with the last generation self-expandable Medtronic CoreValve and the balloon-expandable Edwards Sapien XT. Between 2010 and 2015 consecutive patients treated with the Medtronic CoreValve (N = 100), Edwards Sapien XT (N = 100), Edwards Sapien S3 (N = 100) and Boston Lotus device (N = 100) were enrolled. There was no moderate or severe AR with the new generation devices as compared with 11.5% with last generation devices (p < 0.01). None or trace aortic regurgitation was lowest with the Lotus valve. Pacemaker implantation due to II° or III° atrioventricular block was comparable for the self-expandable CoreValve (21%) and the mechanically deployed Lotus Valve (23%) and lower for the Sapien 3 (15%) and XT valve (8%; p < 0.01). Early safety endpoint at 30 days (21 vs. 9%, p < 0.01), major vascular complications (12 vs. 2.5%, p < 0.01), all-cause mortality (9.5 vs. 2%, p < 0.01) and rate of disabling and non-disabling stroke (7.5 vs. 3.5%, p < 0.01) were significantly lower with the new generation devices. In multivariate analyses, valve type was an independent predictor for 30 days early safety endpoint and 12 months all-cause mortality. TAVR with the new generation Edwards Sapien 3 and Boston Lotus valves was associated with no moderate and severe aortic regurgitation, significantly lower major vascular complications and a significant improvement in 30 days and 12 months outcome.Clinicaltrials.gov NCT02162069.

Transfemoral aortic valve implantation is more successful with the Edwards Sapien 3 compared with the Edwards XT for the treatment of symptomatic severe aortic stenosis.

BACKGROUND: Residual aortic regurgitation (AR) after transfemoral aortic valve implantation (TAVI) is associated with increased mortality. The new Edwards Sapien 3 valve (ES3) is designed to reduce paravalvular AR. AIM: To compare a new-generation and a late-generation balloon-expandable transcatheter heart valve. METHODS: In this study, 100 consecutive patients treated with the ES3 for symptomatic native severe aortic stenosis were compared with 100 consecutive patients treated with the Edwards Sapien XT valve (EXT); all valves were implanted via transfemoral access. We compared residual AR, rate of permanent pacemaker implantation, device success according to the second Valve Academic Research Consortium (VARC-2) criteria and 30-day follow-up. RESULTS: With the ES3, the risk of moderate/severe AR was lower (0% vs 3%), the risk of mild AR was lower (31% vs 40%) and the final result with no AR was higher (P=0.07). The mean aortic gradient was significantly higher with the ES3 (12.2±4.6 vs 9.4±3.9mmHg; P<0.01). Device success according to the VARC-2 criteria was high with the ES3 and the EXT (97% vs 95%; P=0.48). Pacemaker implantation because of higher-grade atrioventricular block was similar: 9.3% after ES3 implantation and 6.9% after EXT implantation (P=0.56). There was significantly less major or life-threatening bleeding with the ES3: 5% vs 14% (P=0.03) and 0% vs 8% (P<0.01), respectively. After 30 days, the VARC-2 early-safety endpoint was significantly lower with the ES3 (P<0.01). CONCLUSIONS: In conclusion, TAVI with the ES3 in patients with symptomatic severe aortic stenosis was associated with no moderate/severe AR, a trend towards a lower rate of mild AR, a significantly lower rate of major or life-threatening bleeding and early safety according to VARC-2 criteria within 30 days compared with the EXT.

Predictors of permanent pacemaker implantation after transfemoral aortic valve implantation with the Lotus valve.

BACKGROUND: Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation is of high clinical relevance, but PPMI rates differ widely between valve types. Although the Lotus valve can be repositioned, reported rates for PPMI are high. The predictors of PPMI after Lotus valve implantation have not been defined yet. METHODS: We analyzed the impact of preexisting conduction disturbances, depth of implantation, oversizing, and amount of calcification on PPMI in 216 patients with severe symptomatic aortic stenosis underdoing Lotus valve implantation. RESULTS: PPMI was required in 39.8% of patients. Patients with need for PPMI compared with patients without need for PPMI had more often the following criteria: male gender (P=.035); preprocedural right bundle-branch block (RBBB) (16.3% vs 0, P<.001); atrioventricular (AV) block first degree (26.7% vs 10.1%, P=.004); higher calcium volume of the left coronary cusp (63.1±87.5 mm3 vs 42.8±49.3 mm3, P=.05); and deeper valve implantation at right coronary (P=.011), noncoronary (P=.026), and left coronary (P=.012) position. Oversizing in relation to annulus and left ventricular outflow tract did not have an impact on need for PPMI. By multiple regression analysis, preprocedural AV block first degree (P=.005), RBBB (P<.001), and depth of implantation (P=.006) were independent risk factors for need of PPMI. CONCLUSIONS: In patients with severe aortic stenosis receiving transfemoral Lotus valve, preexisting AV block first degree, RBBB, and implantation depth are independent predictors of PPMI, highlighting the importance of careful valve positioning.

Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures.

OBJECTIVES: The aim of this study was to evaluate the impact of cerebral embolic protection on stroke-free survival in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Imaging data on cerebral embolic protection devices have demonstrated a significant reduction in number and volume of cerebral lesions. METHODS: A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc., Santa Rosa, California) was used in 34.9% (n = 280) of consecutive patients. In 65.1% (n = 522) of patients TAVR was performed in the identical setting except without cerebral embolic protection. Neurological follow-up was done within 7 days post-procedure. The primary endpoint was a composite of all-cause mortality or all-stroke according to Valve Academic Research Consortium-2 criteria within 7 days. Propensity score matching was performed to account for possible confounders. RESULTS: Both filters of the device were successfully positioned in 280 of 305 (91.8%) consecutive patients. With use of cerebral embolic protection rate of disabling and nondisabling stroke was significantly reduced from 4.6% to 1.4% (p = 0.03; odds ratio: 0.29, 95% confidence interval: 0.10 to 0.93) in the propensity-matched population (n = 560). The primary endpoint occurred significantly less frequently, with 2.1% (n = 6 of 280) in the protected group compared with 6.8% (n = 19 of 280) in the control group (p = 0.01; odds ratio: 0.30; 95% confidence interval: 0.12 to 0.77). In multivariable analysis Society of Thoracic Surgeons score for mortality (p = 0.02) and TAVR without protection (p = 0.02) were independent predictors for the primary endpoint. CONCLUSIONS: In patients undergoing TAVR use of a cerebral embolic protection device demonstrated a significant higher rate of stroke-free survival compared with unprotected TAVR.

Outcome With the Repositionable and Retrievable Boston Scientific Lotus Valve Compared With the Balloon-Expandable Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve Replacement.

BACKGROUND: New generation devices for transfemoral aortic valve replacement were optimized on valve positioning and reduction of residual aortic regurgitation. We compared 30-day, 12-month, and 24-month outcomes of the Boston Scientific Lotus valve (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) valve. Primary end point was all-cause mortality or disabling stroke within 12 months. METHODS AND RESULTS: Between 2014 and 2016, 537 patients were enrolled at our center, and 202 patients received Lotus and 335 ES3. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation was lower with the repositionable and retrievable Lotus valve compared with the ES3. Rate of pacemaker implantation was significantly higher with the Lotus valve compared with the ES3 valve (36.1% versus 14.9%, P<0.01). Valve Academic Research Consortium-2 early safety end point at 30 days was 7.4% with both devices with no difference in all-cause mortality (Lotus, 1.9%; ES3, 1.8%; P=0.87), rate of disabling stroke (Lotus, 1.5%; ES3, 2.1%; P=0.62), or major vascular complications (Lotus, 2.9%; ES3, 2.4%; P=0.69). The primary end point at 12 months was similar between groups. In a propensity score-matched comparison, there was no difference in the primary end point within 12 months (Lotus, 15.5%; ES3, 18.6%; P=0.69) and 24 months (Lotus, 21.9%; ES3, 26.4%; P=0.49). CONCLUSIONS: Transfemoral aortic valve replacement with the ES3 and the Lotus were associated with similar 30-day, 12-month, and 24-month clinical outcomes. Need for permanent pacemaker implantation was significantly higher with the repositionable Lotus device. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02162069.