Prevalence, mechanisms, and prognostic impact of dynamic mitral regurgitation assessed by isometric handgrip exercise.

AIMS: The extent of mitral regurgitation (MR) may vary depending on the haemodynamic situation; thus, exercise testing plays an important role in assessing the haemodynamic relevance of MR. We aim to assess prevalence, mechanisms, and prognostic impact of exercise-induced changes in MR in patients with degenerative MR (DegMR) and functional MR (FMR). METHODS AND RESULTS: We enrolled 367 patients with at least mild MR who underwent standardized echocardiography at rest and during handgrip exercise. Handgrip exercise led to an increase in MR by one grade or more in 19% of DegMR and 28% of FMR patients. In FMR, patients with exercise-induced increases in MR, handgrip exercise led to a reduction in left ventricular stroke volume index, being maintained in DegMR patients. Exercise-induced changes in systolic pulmonary artery pressure were linked to changes in effective regurgitant orifice area (DegMR: r = 0.456; P < 0.001; FMR: r = 0.326; P < 0.001). Thus, 26% of patients with DegMR and FMR developed pulmonary hypertension during exercise. In both cohorts, a significant proportion of patients with non-severe MR at rest and exercise-induced severe MR underwent mitral valve surgery/intervention during follow-up. In FMR patients (but not in DegMR patients), early mitral valve surgery/intervention was independently associated with lower event rates during follow-up [0.177 (0.027-0.643); P = 0.025]. CONCLUSIONS: Handgrip exercise echocardiography provides important information regarding the dynamic nature of MR, exercise-induced changes in left ventricular function, and pulmonary circulation with subsequent consequences for further therapeutic decision making. Thus, it should be considered as a diagnostic tool in symptomatic patients with non-severe MR at rest.

Left ventricular reverse remodeling after transcatheter aortic valve implantation in patients with low-flow low-gradient aortic stenosis.

OBJECTIVES: Left ventricular reverse remodeling (LVRR) is associated with improved outcome in patients with heart failure. Factors associated with and predictive of LVRR in patients with low-flow low-gradient aortic stenosis (LFLG AS) after transcatheter aortic valve implantation (TAVI) and its impact on outcome were assessed. METHODS: Pre- and postprocedural left ventricular (LV) function and volume were investigated in 219 patients with LFLG. LVRR was defined as an absolute increase of ≥10% in LV ejection fraction (LVEF) and reduction of ≥15% in LV end-systolic volume (LVESV). The primary endpoint was the combination of all-cause mortality and rehospitalization for heart failure. RESULTS: The mean LVEF was 35.0 ± 10.0%, with a stroke volume index (SVI) of 25.9 ± 6.0 mL/m2 and LVESV of 94.04 ± 46.0 mL. At a median of 5.2 months (interquartile range, 2.7-8.1 months), 77.2% (n = 169) of the patients showed echocardiographic evidence of LVRR. A multivariate model revealed three independent factors for LVRR after TAVI: SVI of <25 mL/m2 (hazard ratio [HR], 2.31; 95% confidence interval [CI], 1.08-3.58; p < 0.01), LVEF of <30% (HR, 2.76; 95% CI, 1.53-2.91; p < 0.01), and valvulo-arterial impedance (Zva) of <5 mmHg/mL/m2 (HR, 5.36; 95% CI, 1.80-15.98; p < 0.01). Patients without evidence of LVRR showed a significantly higher incidence of the 1-year combined endpoint (32 [64.0%] vs. 75 [44.4%], p < 0.01). CONCLUSIONS: The majority of patients with LFLG AS show LVRR after TAVI, which is associated with favorable outcomes. An SVI of <25 mL/m2, LVEF of <30%, and Zva < 5mmHg/mL/m2 represent predictors of LVRR.

Transcatheter aortic valve implantation with different self-expanding devices-a propensity score-matched multicenter comparison.

OBJECTIVE: Several supra-annular self-expanding transcatheter systems are commercially available for transcatheter aortic valve implantation (TAVI). Comparative data in large-scale multicenter studies are scant. METHODS: This study included a total of 5175 patients with severe aortic stenosis undergoing TAVI with the ACURATE neo (n = 1095), Evolut R (n = 3365), or Evolut PRO (n = 715) by a transfemoral approach at five high-volume centers. Propensity score matching resulted in 654 triplets. Outcomes are reported according to the Valve Academic Research Consortium-3 (VARC-3) consensus. RESULTS: Moderate or severe paravalvular regurgitation (PVR) occurred significantly more often in the ACURATE neo group (5.2%) than in the Evolut R (1.8%) and Evolut PRO (3.3%) groups (p = 0.003). The rates of major vascular-/access-related complications (4.6%, 3.8%, and 5.0%; p = 0.56), type 3 or 4 bleeding (3.2%, 2.1%, and 4.1%; p = 0.12), and 30-day mortality (2.4%, 2.6%, and 3.7%; p = 0.40) were comparable. The rate of new permanent pacemaker implantation (PPI) was significantly lower in the ACURATE neo group (9.5%, 17.6%, and 16.8%; p < 0.001). Independent predictors for 2-year survival were a Society of Thoracic Surgeons (STS) risk score ≥5%, diabetes mellitus, a glomerular filtration rate <30 ml/min, baseline mean transvalvular gradient ≤ 30 mm Hg, treating center, and relevant PVR. CONCLUSION: In this multicenter study, TAVI with the ACURATE neo, Evolut R, or Evolut PRO was feasible and safe. The rate of relevant PVR was more frequent after the ACURATE neo implantation, with, however, lower rates of PPI. Two-year survival was mainly driven by baseline comorbidities.

BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial.

BACKGROUND: Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis. METHODS: The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies. CONCLUSIONS: The BASELINE trial is a head-to-head comparative trial investigating the 2 most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).

Left ventricular-aortic angle is associated with platelet reactivity in patients with aortic stenosis.

The impact of aortic stenosis on platelet reactivity is unclear. Previous studies reported contradicting results. The reason for this is unknown. It is known that flow alterations enhance platelet reactivity. A steep left ventricular-aortic angle (LV-AO-angle) is associated with turbulent flow in the aorta ascendens. Therefore, in this study, we hypothesized that LV-AO-angle is associated with platelet reactivity in patients with severe aortic stenosis. We included 289 patients with severe aortic stenosis and performed cardiac computertomography to assess the LV-AO-angle. Platelet function was evaluated by light transmission aggregometry. Platelet reactivity was higher in patients with a steep LV-AO-angle (ADP: <160°: 66.99% ±â€Š20.72% vs. ≥160°: 60.66% ±â€Š19.85%, P  = 0.009; collagen: <160°: 78.67% ±â€Š13.19% vs. ≥160°: 73.85% ±â€Š14.44%, P  = 0.003). Using Spearman correlation, ADP and collagen-induced aggregation was associated with LV-AO-angle (ADP: r  = -0.19, P  = 0.0009, R2  = 0.022; collagen: r  = -0.21, P  = 0.0004, R2  = 0.027). Apart from platelet reactivity, body weight, history of myocardial infarction and other factors were associated with steep LV-AO-angle. However, multivariate cox-regression (including body weight, comorbidities, history of MI and cardiac surgery, kidney function and laboratory parameters) revealed that LV-AO angle was a robust predictor of ADP and collagen-induced platelet aggregation. Steep LV-AO-angle is associated with enhanced platelet reactivity in patients with aortic stenosis. This could be the reason of contradicting results regarding platelet function in patients with aortic stenosis in previous studies. In addition, enhanced platelet reactivity in steep LV-AO-angle aortic stenosis patients might be a promising target in pathogenesis of aortic stenosis.

Aortic angle distribution and predictors of horizontal aorta in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Horizontal aorta (HA) is an anatomical feature that can pose significant technical challenges for the successful positioning of the bioprosthetic valve during transcatheter aortic valve replacement (TAVR). Physiological range of aortic angle (AA) is unknown; hence there is no cutoff AA for classifying HA. Moreover, patient characteristics predicting HA are under-investigated. METHODS: This was a retrospective analysis of prospective collected data from 16 heart valve centers in Europe. The study utilized a common dataset with a priori agreed-upon definitions and variables. Eligible patients underwent TAVR between 2014 and 2020 and had multidetector computed tomographic imaging data available for determining the AA. The analysis described the distribution of AA and potential predictors of HA. Inter-center variability was also explored. RESULTS: For 4022 patients analyzed, the mean AA ± standard deviation was 49.4° ± 9.4° (median 49°, inter-quartile range [IQR] 12°, range 18-90°). There was no significant difference in mean AA between men and women (49.4° ± 9.1° vs. 49.6° ± 9.3°, respectively; p = 0.53); therefore, 49.4° was accepted as the cutoff value for HA in subsequent analyses. Covariates significantly associated with HA included age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p < 0.001), body mass index (OR: 1.06, 95% CI: 1.05-1.08, p < 0.01), previous cardiac surgery (OR: 0.58, 95% CI: 0.45-0.75, p < 0.001), and porcelain aorta (OR: 0.66, 95% CI: 0.52-0.85, p = 0.001). Some inter-center variability was observed. CONCLUSIONS: We defined 49.4° as the mean AA, and also associated predictors of HA in a large case series of patients with severe aortic stenosis candidates for TAVR.

Factors associated with a high or low implantation of self-expanding devices in TAVR.

OBJECTIVES: Optimizing valve implantation depth (ID) plays a crucial role in minimizing conduction disturbances and achieving optimal functional integrity. Until now, the impact of intraprocedural fast (FP) or rapid ventricular pacing (RP) on the implantation depth has not been investigated. Therefore, we aimed to (1) evaluate the impact of different pacing maneuvers on ID, and (2) identify the independent predictors of deep ID. METHODS: 473 TAVR patients with newer-generation self-expanding devices were retrospectively enrolled and one-to-one propensity-score-matching was performed, resulting in a matching of 189 FP and RP patients in each cohort. The final ID was analyzed, and the underlying functional, anatomical, and procedural conditions were evaluated by univariate and multivariate analysis. RESULTS: The highest ID was reached under RP in severe aortic valve calcification and valve size 26 mm. Multivariate analysis identified left ventricular outflow (LVOT) calcification [OR 0.50 (0.31-0.81) p = 0.005*], a "flare" aortic root [OR 0.42 (0.25-0.71), p = 0.001*], and RP (OR 0.49 [0.30-0.79], p = 0.004*) as independent highly preventable predictors of a deep ID. In a model of protective factors, ID was significantly reduced with the number of protective criteria (0-2 criteria: - 5.7 mm ± 2.6 vs. 3-4 criteria - 4.3 mm ± 2.0; p < 0.0001*). CONCLUSION: Data from this retrospective analysis indicate that RP is an independent predictor to reach a higher implantation depth using self-expanding devices. Randomized studies should prove for validation compared to fast and non-pacing maneuvers during valve delivery and their impact on implantation depth. TRAIL REGISTRATION: Clinical Trial registration: NCT01805739. STUDY DESIGN: Evaluation of the impact of different pacing maneuvers (fast ventricular pacing-FP vs. rapid ventricular pacing-RP) on implantation depth (ID). After one-to-one-propensity-score-matching, independent protective and risk factors for a very deep ID beneath 6 mm toward the LVOT (< - 6 mm) were identified. Stent frame pictures as a courtesy by Medtronic®. AVC aortic valve calcification.

Impact of Transcatheter Aortic Valve Implantation on Thrombin Generation and Platelet Function.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an evolving treatment of severe aortic valve stenosis. However, thromboembolic events such as stroke are common, predominantly early after TAVI. Optimal periprocedural antithrombotic regime is unknown. Especially, as antithrombotic medication enhances bleeding risk, thrombin generation and platelet function are crucial in the pathogenesis of ischemic events. However, the impact of the TAVI procedure on thrombin formation and platelet reactivity is not known by now. METHODS: We evaluated thrombin levels using thrombin-antithrombin (TAT) complexes and prothrombin fragments (PTFs) using enzyme-linked immunosorbent assay. Furthermore, platelet reactivity was measured via light transmission aggregometry before and 2 hours after TAVI in 198 patients. RESULTS: TAT complexes and PTF F1 + 2 substantially increased during TAVI. Postprocedurally, TAT complexes and PTF were significantly higher after TAVI compared with percutaneous coronary intervention due to acute myocardial infarction, while preprocedural TAT complexes and PTF F1 + 2 did not differ. In contrast, platelet reactivity was not altered early after TAVI. Only adenosine diphosphate-induced aggregation was reduced, reflecting preprocedural loading with clopidogrel. CONCLUSION: In this pilot study, we were able to demonstrate that thrombin generation is significantly increased early after TAVI, while platelet function is not affected. Increased thrombin concentrations may contribute to the high risk of postprocedural thromboembolic events. This leads to the hypothesis that extended peri-interventional anticoagulation early after TAVI may be an approach to reduce thromboembolic events.

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.

Risk of mortality following transcatheter aortic valve replacement for low-flow low-gradient aortic stenosis.

BACKGROUND: Low-flow low-gradient (LF-LG) aortic stenosis (AS) is associated with high mortality, even after transcatheter aortic valve replacement (TAVR). Further knowledge of risk indicators is needed and a clinical risk score would be desirable for optimizing patient selection and therapeutic strategy. METHODS: The study cohort comprised of 219 consecutive LF-LG AS patients undergoing TAVR from 2008 to 2018 in two high-volume German centers. Predictive factors for one-year all-cause mortality were defined according to a Cox proportional hazard model. RESULTS: At one-year follow-up after TAVR, 28% of patients had died. A multivariate model revealed six independent predictors of one-year mortality: history of myocardial infarction (HR 2.05, 95%CI 1.13-3.72), eGFR < 30 ml/min/1.73m2 (HR 2.75, 95%CI 1.48-5.11), tricuspid regurgitation moderate or more (HR 2.06, 95%CI 1.14-3.72), stroke volume index < 25 mL/m2 (HR 2.03, 95%CI 1.14-3.62), self-expandable device (HR 2.72, 95%CI 1.17-6.27), and non-transfemoral approach (HR 3.42, 95%CI 1.28-9.14). The Rhineland Risk Score (RRS) consisting of these variables (c statistic 0.75, 95%CI 0.68-0.82, p < 0.001) was superior to the EuroSCORE II (c statistic 0.63) and STS-PROM score (c statistic 0.69) at predicting one-year mortality. Patients with a RRS ≥ 8 had a prohibitive risk of one-year mortality of 67.6% (95%CI 52.0-82.4%). CONCLUSION: In patients with LF-LG AS, history of myocardial infarction, renal dysfunction, tricuspid regurgitation, a low stroke volume index, self-expandable device, and non-femoral approach were associated with increased 1-year mortality after TAVR. The RRS might serve as a helpful tool for risk prediction and patient selection for TAVR in patients with LF-LG AS.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

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.

Novel insights on outcome in horizontal aorta with self-expandable new-generation transcatheter aortic valve replacement devices.

BACKGROUND: The impact of a horizontal aorta (HA) on adverse events (AE) following in transcatheter aortic valve replacement (TAVR) is dealt controversially. Using new-generation self-expandable devices, we aimed to reevaluate an appropriate threshold of the aortic root angulation (ARA) in terms of HA and its impact on outcome. METHODS: The 466 consecutive patients, who underwent transfemoral TAVR with self-expandable new-generation devices, were analyzed. Patients were classified into cases with HA (ARA ≥ 51°; n = 225; 48%) and without HA (ARA <51°; n = 241; 52%). Primary endpoints were device success and 30-day mortality. Secondary endpoints were specific AE according to VARC-2 definitions. RESULTS: Contrast use (107.6 ± 50.1 vs. 94.1 ± 46.1 ml; p = .033) and radiation dose (3,176 [1,928-5,596] vs. 2,651 [1,643-4,394] Gyxcm2 ; p = .016) were higher in HA. Primary device success was comparable (97.1 vs. 97.8%; p = .773). A 30-day mortality (3.3 vs. 0.4%; p = .038, plogrank = 0.025), stroke (7.1 vs. 2.7%; p = .033), and major vascular complications (MVASC) (6.6 vs. 2.7%; p = .050) were more frequent in HA. Pronounced calcification of the noncoronary cusp and left ventricular outflow tract, the condition of HA, as well as repositioning maneuvers were independent predictors for overall specific AE. CONCLUSION: An HA above 51° is associated with an increased rate of stroke, MVASC, and 30-day mortality. Valve size and asymmetric calcification affect the incidence of repositioning maneuvers and subsequent VARC-2 AE, indicating that an HA-together with specific anatomic features-remains a crucial factor for TAVR-related outcome with self-expandable new-generation devices.

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

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

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

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

Predictors of Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement.

OBJECTIVES: The aim of this study was to evaluate the predictors of left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). BACKGROUND: LVOT obstruction is a major concern with TMVR, but limited data exist regarding its predictors and impact on outcomes. METHODS: Patients with pre-procedural multidetector row computed tomography (MDCT) undergoing TMVR for failed mitral bioprosthetic valves (valve-in-valve), annuloplasty rings (valve-in-ring), and mitral annular calcification (valve-in-MAC) were included in this study. Echocardiographic and procedural characteristics were recorded, and comprehensive assessment with MDCT was performed to identify the predictors of LVOT obstruction (defined as an increment of mean LVOT gradient ≥10 mm Hg from baseline). The new LVOT (neo-LVOT) area left after TMVR was estimated by embedding a virtual valve into the mitral annulus on MDCT, simulating the procedure. RESULTS: Among 194 patients with pre-procedural MDCT undergoing TMVR (valve-in-valve, 107 patients; valve-in-ring, 50 patients; valve-in-MAC, 37 patients), LVOT obstruction was observed in 26 patients (13.4%), with a higher rate after valve-in-MAC than valve-in-ring and valve-in-valve (54.1% vs. 8.0% vs. 1.9%; p < 0.001). Patients with LVOT obstruction had significantly higher procedural mortality compared with those without LVOT obstruction (34.6% vs. 2.4%; p < 0.001). Receiver-operating characteristic curve analysis showed that an estimated neo-LVOT area ≤1.7 cm2 predicted LVOT obstruction with sensitivity of 96.2% and specificity of 92.3%. CONCLUSIONS: LVOT obstruction after TMVR was associated with higher procedural mortality. A small estimated neo-LVOT area was significantly associated with LVOT obstruction after TMVR and may help identify patients at high risk for LVOT obstruction.

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

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

Secondary right heart failure due to haemodynamically relevant iatrogenic atrial septal defect: does the sequence of structural interventions sometimes matter? A case report.

BACKGROUND: Edge-to-edge mitral valve repair is a common procedure for treating severe symptomatic mitral valve regurgitation in patients not eligible for surgery. CASE SUMMARY: After necessary transseptal puncture during the MitraClip procedure, an iatrogenic atrial septal defect (iASD) routinely remains and closes spontaneously in most cases. We present a case in which this shunt persisted due to increased left heart pressure, causing repeated rehospitalization, and ultimately requiring interventional closure: after successful transcatheter edge-to-edge repair of severe, symptomatic mitral regurgitation, the iASD persisted presumably due to underestimated paradoxical low-flow, low-gradient aortic valve stenosis. Despite transcatheter aortic valve implantation, the iASD became haemodynamically relevant requiring successful interventional iASD closure in the end after a long period of rehospitalizations. We evaluated the symptoms, haemodynamic, and functional characteristics of the patient using several diagnostic tools, as well as the comorbidities of the patient, in terms of their potential to favour the persistence and haemodynamic relevance of iASDs. DISCUSSION: The combination of sophisticated diagnostic tools, such as cardiac magnetic resonance imaging and transoesophageal echocardiography (TOE), physical examination, and symptoms can be used to identify patients vulnerable to the development of a haemodynamic-relevant iASD that will need early interventional treatment.

SeQuent Please vs. Pantera Lux drug coated balloon angioplasty in real life: Results from the Düsseldorf DCB registry.

BACKGROUND: In-stent restenosis (ISR) is still a major concern in interventional cardiology. Drug coated balloon (DCB) angioplasty has been shown to be a promising option in treatment of ISR. However heterogeneity of different DCBs in suppression of neointimal growth has been described in a porcine model of coronary ISR. Therefore, in this registry analysis, we compared two frequently used paclitaxel eluting DCBs, the SeQuent Please and the Pantera Lux DCB. METHODS: 571 patients were treated with DCB angioplasty at the Heinrich-Heine University Düsseldorf between 2009 and 2012. Follow-up was conducted during ambulatory care at our department. Major adverse cardiac events (death, myocardial infarction [MI] and target lesion revascularization) were registered during hospitalization and follow-up. RESULTS: Patient characteristics, prior diseases, clinical presentation, ejection fraction, procedural success and lost-for-follow-up did not differ between patients treated with the SeQuent Please and. The Pantera Lux DCB. MACE during hospital course were similar as well (Pantera Lux: 6 patients [1.6%] vs. SeQuent®Please: 3 patients [1.5%], relative risk 1.06, 95% confidence interval 0.3-4.2, P=0.93). Event free survival was significantly longer in patients treated with the Pantera Lux DCB as compared to SeQuent Please DCB (Hazard ratio: 0.65, 95% confidence interval 0.43-0.98; P value of log-rank test: 0.0405). CONCLUSION: MACE free survival was longer in Pantera Lux DCB treated patients as compared to SeQuent Please treated patients. This finding has to be confirmed in future clinical trials.

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.