Trace Aortic Regurgitation Research Articles

Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication

BackgroundThe balloon expandable Myval transcatheter heart valve (THV) showed encouraging results regarding residual aortic regurgitation (AR) from multiple observational studies. The newly designed Myval Octacor has been introduced recently, aiming for a reduction in AR and improved performance. ObjectivesThe focus of this study is to report the incidence of AR using the validated quantitative Videodensitometry angiography technology (qLVOT-AR%) in the first in human use of the Myval Octacor THV system. MethodologyWe report on the first in human use of the Myval Octacor THV system in 125 patients in 18 Indian centres. Independent retrospective analysis of the final aortograms following implantation of the Myval Octacor was performed using the CAAS-A-Valve software. AR is reported as a regurgitation fraction. The previously validated cutoff values have been used to identify ≥moderate AR (RF% >17%), mild (6% < RF% ≤17%), and none or trace AR (RF% ≤ 6%). ResultsFinal aortogram was analysable for 103 patients (84.4%) among the 122 available aortograms. 64 (62%) patients, had tricuspid aortic valve (TAV), 38 (37%) with bicuspid AV (BAV), and one with unicuspid AV. The median absolute RF% was 2% [1, 6], moderate or more AR incidence was 1.9%, mild AR in 20.4%, and none or trace AR in 77.7%. The two cases with RF% >17% were in the BAV group. ConclusionThe initial results of Myval Octacor using quantitative angiography-derived regurgitation fraction demonstrated a favourable outcome regarding residual AR, possibly due to improved device design. Results must be confirmed in a larger randomised study, including other imaging modalities.

Prevalence of Echocardiographic Evidence of Trace Mitral and Aortic Valve Regurgitation in 50 Clinically Healthy, Young Adult Labrador Retrievers without Heart Murmur.

Background-Though physiologic regurgitation of the right-sided cardiac valves is well recognized in dogs and other mammals, the prevalence of trace insufficiency of the mitral and aortic valves in clinically healthy, young adult dogs is unknown. Methods-In this observational cross-sectional study, 50 clinically healthy, young adult Labrador retrievers without an audible heart murmur were enrolled. All dogs were bred and owned by a single organization. Cardiac screening was requested for all dogs that were intended for breeding. These dogs underwent a cardiac auscultation and transthoracic echocardiography by a veterinary cardiology specialist. If mitral or aortic valve regurgitation was noticed, the jet size was subjectively assessed on color Doppler echocardiography. Pedigree analysis was performed to reveal a possible hereditary background of mitral valve regurgitation. Results-The prevalence of trivial mitral valve regurgitation was 52% with no significant predisposition to gender (p = 0.86) or haircoat color (p = 0.68). The prevalence of aortic valve regurgitation was 4%. Pedigree analysis for mitral valve regurgitation showed familial clustering, suggesting a hereditary background of the trait. Conclusions-The prevalence of silent trace mitral valve regurgitation in young adult Labrador retrievers was high. Because the regurgitant jet was trivial in all dogs, it is probably physiologic.

Association of Mild Valvular Lesions With Long-term Cardiovascular Outcomes Among Black Adults

Little is known about the long-term outcomes of mild valvular lesions. To examine the associations of 3 major types of valvular lesions (aortic stenosis, trace or mild aortic regurgitation, and trace or mild mitral regurgitation) with risk of cardiovascular mortality, coronary heart disease (CHD), stroke, heart failure, and atrial fibrillation. This cohort study analyzed data from the ongoing Atherosclerosis Risk in Communities study and focused on Black participants in the Jackson, Mississippi, site who underwent echocardiography at visit 3 from 1993 to 1995. Data analysis was conducted between April 2021 and February 2022. Three valvular lesions were analyzed: aortic sclerosis, aortic regurgitation (trace or mild), and mitral regurgitation (trace or mild). The outcomes were cardiovascular mortality, coronary heart disease, heart failure, stroke, and atrial fibrillation. Multivariable Cox proportional hazards regression models were used to examine the independent associations between the 3 valvular lesions and these outcomes. A total of 2106 Black participants were included, with a mean (SD) age of 59.1 (5.6) years and 1354 women (64.3%). The baseline prevalence was 7.7% for aortic sclerosis, 15.1% for aortic regurgitation (6.1% with trace, and 9.0% with mild), and 43.0% for mitral regurgitation (29.4% with trace, and 13.6% with mild). During a median (interquartile interval) follow-up of 22.5 (15.6-23.5) years, 890 participants developed at least 1 cardiovascular outcome. Each valvular lesion was significantly associated with at least 1 cardiovascular outcome: aortic sclerosis was associated with cardiovascular mortality (adjusted hazard ratio [HR], 1.54; 95% CI, 1.06-2.22), mild mitral regurgitation was associated with atrial fibrillation (HR, 1.47; 95% CI, 1.09-1.99), and trace or mild aortic regurgitation was associated with all outcomes (HRs ranging from 1.45 [95% CI, 1.17-1.81] to 1.75 [95% CI, 1.29-2.37]) except stroke. The total number of valvular lesions had graded associations with all cardiovascular outcomes except stroke: the HR of cardiovascular mortality was 1.77 (95% CI, 1.18-2.65) for those with 2 to 3 lesions and was 1.44 (95% CI, 1.05-1.96) for those with 1 lesion vs no lesions. Results of this study indicate an association between valvular lesions, even at mild stage, and a long-term risk of cardiovascular events, suggesting the importance of recognizing and monitoring these valvular conditions.

Surgical outcome of repair of aortic valve prolapse and regurgitation associated with ventricular septal defect.

Objective:To analyze the outcome of repair of aortic valve disease associated with various types of ventricular septal defect.Methods:In a retrospective observational study design, data of seventy-two patients of ventricular septal defect (VSD) associated with aortic valve prolapse (AVP) and aortic regurgitation (AR) who was operated in Punjab Institute of cardiology from May 2016 to April 2020 was collected. Depending on presence of AR, all patients were divided in four groups. Group-I (VSD and AVP but no AR) had fifteen patients. Only VSD was closed in this group. Group-II (VSD and Mild AR) had forty patients, only VSD was closed in this group as well. Group-III (VSD and Moderate AR) had ten patients, VSD closure and aortic valve repair was done. Group-IV (VSD and severe AR) had seven patients. Aortic valve was repaired in five patients and replaced (AVR) in two patients along with VSD closure. Associated anomalies were addressed as well.Results:Group-I: Twelve out of fifteen patients (80%) showed no post-operative AR. While two patients (13.3%) showed Trace AR. Single patient (6.6%) showed mild AR. There results were unchanged after mean follow up of 36 months. Group-II: Eight out of forty patients (20%) had no AR, while eight (20%) had trace AR. Twenty-three (57.5%) patients had mild AR. Single (2.5%) patient had moderate AR. After follow up of 24 months the patient with moderate AR progressed to severe AR. We are planning to do Aortic Valve Replacement (AVR) in this case. Rest of cases showed no progression of disease. Group-III: Two out of ten patients (20%) had no AR, four (40%) had trace AR, while four (40%) had mild AR. Mean follow up was 42 months (2.5 years). Neither trace nor mild AR progressed to severe or moderate AR. Group-IV: Among seven patients, five underwent repair while two had AVR. Out of five patients who underwent aortic valve repair, four patients (57.1%) were declared mild AR, while severe AR was converted to moderate AR in single patient (14.28%). Mean follow up was 18 months. The moderate AR patient has progressed to severe AR for last six months and we are planning to do AVR in this patient. Postoperative echo of patients with AVR showed adequately functioning aortic valve with AVPG mean 10 mmHg and 15 mm Hg respectively, with no residual AR.Conclusions:Aortic regurgitation associated with VSD is a congenital lesion with continuously active aortic valve disease resulting in significant morbidity and mortality. Early diagnosis, effective treatment and meticulous follow up decelerate and in most cases arrest the disease process.

Identification of the intermittent nature of trace mitral and/or aortic regurgitation: long-term longitudinal echocardiogram study in children with Dravet syndrome treated with fenfluramine

Abstract Background Previous studies have identified the presence of trace valvular regurgitation; however, these studies are typically cross-sectional assessments at a single point in time and provide no information regarding the natural history of trace aortic or mitral regurgitation (AR, MR). To our knowledge no study has assessed valve function in growing children with longitudinal echocardiogram (ECHO) assessments. Purpose To monitor cardiac valve function with regular, standardized ECHOs in patients with Dravet syndrome (DS) treated with fenfluramine for up to 3 years. Methods Patients with DS who completed either of two double-blind Phase 3 clinical trials were eligible to enroll in the open label extension (OLE) study. Patients were to be excluded from entry into the double-blind trials if they exhibited any degree of AR or MR, including trace; or pulmonary artery hypertension (PAH). However, trace MR or AR were not exclusion criteria for continuation into the OLE study. All patients had an ECHO prior to initiation of treatment in the double-blind study, after 6 to 8 weeks of treatment, and at the end of that study. In the OLE study, ECHOs were performed at study week 4, 5, or 6, and every 3 months thereafter. Valve morphology was also examined. Results As of September 1, 2019 a total of 330 patients had enrolled in the OLE study and received at least one dose of fenfluramine. The average age of patients at enrollment was 9.0±4.6 years, 27.6% were &amp;lt;6 years old, and 54.5% were male. The median duration of treatment with fenfluramine in the OLE study was 631 days (min, max; 7, 1086 days), and a total of 2,691 ECHOs had been performed. The point prevalence of trace MR was 10.6% at OLE study entry and ranged from 2.8% to 12.9% thereafter. All instances of trace MR were transient events that reverted to absent or oscillated between trace and absent at later study visits. Four patients demonstrated trace AR at one or more visits and all had reverted to absent at their most recent examination. No changes in valve morphology were observed. Conclusions In this long-term longitudinal ECHO study in DS children treated with fenfluramine, we identified that trace MR and AR were intermittent and not predictive of future valve disease. In all cases trace reverted to absent regurgitation at subsequent ECHOs. No valve morphological changes were seen. The intermittent and transient nature of trace regurgitation observed in this study is consistent with current ECHO guidelines, which consider trace regurgitation to be a normal physiologic phenomenon. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Zogenix, Inc.

Utility of the Mitral Valve Doppler Velocity Index in Detecting Significant Mitral Regurgitation Post-Surgical Mitral Valve Repair

Background: The mitral valve (MV) Doppler velocity index (DVI) (velocity time integral ratio of the continuous-wave MV and pulsed-wave left ventricular outflow tract (LVOT) measurements) is useful in the detection of MV prosthesis dysfunction (stenosis or regurgitation). The value of this Doppler velocity index (DVI) in the detection of significant mitral regurgitation (MR) post-surgical MV repair is investigated in this large dataset. Methods: A retrospective database search for surgical MV repair transthoracic echocardiograms performed between 2004 and 2019 at the Prince Charles Hospital was executed. Two groups (Group 1 - moderate or more MR and Group 2 - trace or no MR) were compared. DVI was calculated in studies with no or trace aortic regurgitation and no significant LVOT or MV obstruction. For Group 2, studies with a mean MV pressure gradient >3 mmHg were also excluded. Results: Of 7,739 MV repair studies in the database, 1,303 studies in 728 patients (aged 62 ± 17 years, 67% males) met the study criteria. There were 561 studies in Group 1 and 741 studies in Group 2. There was a significant difference in DVI between Group 1 (2.21 ± 0.68) and Group 2 (1.92 ± 0.48, p < 0.0001). The receiver operator curve (ROC) analysis identified a cut-off of 2.13 for differentiating between Groups 1 and 2 with a sensitivity and specificity of 51.69% and 70.72%, respectively and an area under the curve (AUC) of 0.634. Conclusions: A DVI >2.13 may be useful in detecting significant MR following MV repair, especially when MR severity is difficult to evaluate by traditional methods.

EP07 AORTIC VALVE REPAIR TECHNIQUES: AN EARLY EXPERIENCE FROM A SINGLE UK CENTRE

Background and aim: Aortic valve repair (AVr) is an evolving area with only few European centres reporting a large volume experience. Very few other surgical units have adopted this approach, even in patients with pure aortic regurgitation (AR). Our aim is to report our early experience with AVr techniques. Method: 59 patients with a mean age of 49 years (range 19–85) underwent AVr for either primary (cusp prolapse or perforation) or secondary (aortic root and/or ascending aneurysms) AR. 14 patients had a bicuspid aortic valve. Standard repair techniques were used including: sub-commissural annuloplasty, STJ remodelling, free-edge plication, commissural resuspension, raphe resection, free-edge reinforcement and VSRR. Results: All patients underwent successful AVr including 1 patient who required a 2nd pump run. The post-bypass TOE demonstrated no/trace AR in 49 (83%) cases, mild central AR in 8 (13.6%) and mild eccentric AR in only 2 (3.4%) cases. 30 day survival was 100%. 2 patients suffered post-operative strokes, none required PPM insertion. At a mean clinical follow-up of 4.7 ± 2.7 years all patients are alive and well. Echo follow-up (2.3 ± 1.9 y) showed: no or trace AR in 25 patients (42.4%), mild AR in 22 patients (37.3%), moderate AR in 11 patients (18.6%), severe AR in 1 patient (1.7%), who underwent re-do AVR 5 years after VSRR. Freedom from re-operation was 87% at 8 years. Conclusion: Despite achieving an excellent immediate (post-bypass) technical result, we remain cautious about the long-term durability of AVr procedures. We therefore continue to carefully evaluate AVr in our practice.

Evaluation of the intraoperative transesophageal echocardiography for the aortic valve reconstruction

Objective: To explore the value of the intraoperative transesophageal echocardiography during the aortic valve reconstruction. Methods: The echocardiographic features were retrospectively summarized in 19 patients (male: 15 cases; female: 4 cases; age ranged from 12 to 65 years, mean age: 37.7 years) with aortic valve reconstruction at Beijing Anzhen Hospital between October 2014 and October 2016. Results: The findings of the neo-aortic valve on the transesophageal echocardiography included the slightly thickened and hyperechogenicity of the commission, especially the central coaptation point of the neo-valve. Trace aortic regurgitation was noted in 9 cases after operation, mild aortic regurgitation in 1 case and no aortic regurgitation in 9 cases. The velocity of the aortic valve increased significantly in 2 cases. Compared with pre-operation, the diameter of ascending aorta[(32.7±6.1) mm vs (36.4±6.3) mm, P<0.001]and the inner diameter of left ventricle[(48.3±6.1) mm vs (59.1±7.3) mm, P<0.001]decreased significantly after operation, the coaptation length of aortic valve[(6.6±1.3) mm vs (2.2±0.7) mm, P<0.001]significantly increased than that of pre-operation. The mean immediate velocity after operation (175 cm/s) was slightly higher than that (165 cm/s) of 3-month follow-up after surgery, but with no significant difference (P=0.367). Severe aortic regurgitation was found 15 days after operation in 1 case and 12 months after operation in 2 cases. Conclusion: Intraoperative transesophageal echocardiography is a useful tool to evaluate the result of the aortic valve reconstruction.

Aortic valve construction using pericardial tissue: short-term single-centre outcomes†

Aortic valve construction using pericardial tissue has been known since the late 1960s. The procedure was re-introduced by Ozaki in 2010 and is currently used to treat specific aortic valve diseases. The exact sizing of the neo-cusps and the insertion of the commissures remain the keys to success when performing this procedure. We evaluated our experience using modified custom-made templates. In this prospective single-centre study, we evaluated 52 consecutive patients who underwent aortic valve construction between September 2015 and March 2017 using either autologous (16 patients, 30.8%) or tissue-engineered pericardium (36 patients, 69.2%). Most patients (34, 65.4%) presented with aortic stenosis or endocarditis (5, 9.6%). Twenty patients had bicuspid and 5 had unicuspid valves. A modified sizing technique with specially designed templates was used. The primary end point was early death; the secondary end points were major adverse cardiac and cerebrovascular events, freedom from reoperation and overall mortality rate. Echocardiographic follow-up was performed intraoperatively and at 12-month intervals. The mean age was 60 ± 14 years; 63.5% were men; and 34 (65.4%) patients had combined procedures. The mean cross-clamp time was 99 ± 17 min. Early outcomes included 1 stroke, 2 patients needing short-term dialysis and 1 death. During follow-up (mean 11.2 ± 4.8 months), trace aortic regurgitation was observed in 4 patients; the mean pressure gradient was 6.8 ± 2.9 mmHg. Three patients died later (of non-cardiac reasons), and 5 patients needed reoperation due to endocarditis. Aortic valve construction using pericardial tissue could be an alternative in middle-age patients presenting with aortic valve disease in whom valve repair was not possible. The newly designed templates allow exact sizing of the neo-cusps and optimal commissure implantation; however, long-term follow-up in a larger cohort is warranted to assess the durability of the neo-valves.

Safety and feasibility of sheathless transfemoral aortic valve implantation

Objective: To investigate the safety and feasibility of sheathless transfemoral aortic valve replacement (TAVR). Methods: In this prospective study, we enrolled 23 patients with severe aortic stenosis (AS) who were inoperable or at high-risk for surgical aortic valve replacement operation in Fuwai hospital From September 2012 to June 2015. Multislice spiral CT and angiography of femoral artery showed that all patients had minimal femoral artery diameters (<6.5 mm) and severe calcification which was not suitable for transfemoral TAVR through sheath. We attempted to apply the sheathless transfemoral TAVR using Venus-A prosthesis without sheath insertion, and procedure related complication during the procedure and hospital stay were observed. Results: The 6 mm×30 mm balloon was used for femoral artery predilation in 1 patient with iliofemoral artery stenosis before delivery system was transported. In the other 22 patients, the delivery system was transported directly. A total of 21 patients finished TAVR with transfemoral sheathless technique. In 2 patients, prosthesis was unable to fully expand after release due to severe valve calcification, and patients received urgent surgical aortic valve replacement. One patient had valve dislocation into the ascending aorta that was not related to the sheathless replacement technique, and delivery system and Venus-A valve were removed after femoral artery was opened surgically, and repeated sheathless TAVR implantation was performed and was successful. Moderate aortic regurgitation occurred in 2 patients immediately after procedure, and trace or mild aortic regurgitation was detected in rest of the patients. One patient had puncture site rupture and bleeding after procedure, and was successfully treated by balloon compression without blood transfusion. Complete atrioventricular block occurred in 3 patients within 24 hours after procedure and lasted after 48-72 hours, permanent pacemakers were implanted in these patients. Conclusion: The sheathless transfemoral technique in TAVR is safe and feasible in severe aortic stenosis patients with small access vessel diameter.

Transthoracic Echocardiography to Assess Aortic Regurgitation after TAVR: A Comparison with Periprocedural Transesophageal Echocardiography

Background: We aimed to compare periprocedural transesophageal echocardiography (TEE) with postprocedural transthoracic echocardiography (TTE) for the diagnosis of aortic regurgitation (AR). Methods and Results: TEE and TTE images of 163 transcatheter aortic valve replacement (TAVR) patients (mean age 81 ± 8 years; 56% men) were reviewed separately and blinded to each other as well as to all clinical data. The median time between TEE during TAVR (TEE/TAVR) and TTE was 4 days (IQR 2-10 days). After TAVR, 48% of the patients had at least trace AR by TEE, 56% by angiography and 67% by TTE. The majority of AR was paravalvular (78%). More patients were classified with mild-to-moderate AR by TTE than by TEE (44 vs. 22%, p < 0.01). When examining the 46 patients with AR by TTE which was not at TEE/TAVR, both systolic and diastolic blood pressure (SBP and DBP) were significantly higher during TTE than during TEE (mean ΔSBP = 9 ± 4 mm Hg and mean ΔDBP = 6 ± 2 mm Hg, p < 0.01 for both). No differences in BP between TEE and TTE were found among patients with no AR or among those who had AR in both studies. At a median follow-up of 185 days (IQR 39-424 days), the overall mortality was 17%, but this was not associated with the presence of AR on TTE or TEE. Conclusions: Patients' hemodynamic conditions may result in underdiagnosis of paravalvular regurgitation in periprocedural TEE. Our findings suggest that a postprocedural evaluation for AR by TTE could serve as a reasonable alternative to TEE for the evaluation of AR.

The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation

BackgroundResidual paravalvular moderate or severe aortic regurgitation (AR) has been an independent risk factor for mortality after transcatheter aortic valve implantation (TAVI). The design of the third generation Edwards Sapien 3 (ES3; Edwards Lifesciences, Irvine, CA, USA) valve was optimized with an outer skirt to address the issue of paravalvular AR. Methods and resultsWe compared 100 consecutive patients treated with the ES3 for severe aortic stenosis with 100 patients treated with the Medtronic CoreValve (CV; Medtronic, Minneapolis, MN, USA) (Clinical Trial Registration: NCT02162069). We evaluated post-procedural AR, rate of permanent pacemaker implantation, device success, and 30-day clinical outcome according to the criteria of the Second Valve Academic Research Consortium (VARC-2). Frequency of post-procedural moderate or severe AR was significantly lower with ES3 compared to CV (0% vs. 20%, p<0.01), none or trace AR significantly higher with ES3 (69% vs. 38%, p<0.01) as well as device success (97% vs. 73%, p<0.01). There was a significantly lower need for permanent pacemaker implantation with ES3 compared with CV (14% vs. 31%, p<0.01). Cardiovascular mortality at 30 days was significantly lower with ES3 (0% vs. 6%, p=0.01), and the combined endpoint “early safety” was met significantly less with ES3 (10% vs. 21% with CV, p=0.03). ConclusionsTransfemoral TAVI with the ES3 compared with the CV was associated with a significantly lower rate of moderate or severe AR, significantly lower need for pacemaker implantation, and a significantly higher rate of device success according to VARC-2.

Dilatation of the ascending aorta is associated with presence of aortic regurgitation in patients after repair of tetralogy of Fallot

To evaluate the association between aortic morphology and elasticity with aortic regurgitation in surgically corrected of tetralogy of Fallot (TOF) patients. We retrospectively identified 72 consecutive patients with surgically corrected TOF and 27 healthy controls who underwent cardiac MRI evaluation. Velocity-encoded cine MRI was used to quantify degree of aortic regurgitation (AR) in TOF patients. Ascending aorta diameters were measured at standard levels on MRA images. Aortic pulse-wave velocity (PWV) was quantified with MRI. Morphological and functional MRI variables were compared between groups of TOF patients with and without clinically relevant AR and controls. The association between aortic morphology and elasticity with the presence of AR was evaluated using univariate and multivariate logistic regression. The majority of TOF patients had only trace AR. Nine TOF patients (12 %) had an AR fraction higher than 15 %. Indexed aorta diameter at the sinotubular junction (p = 0.007), at the RPA level (p = 0.006), and low left ventricular ejection fraction (LVEF) (p = 0.015) showed the strongest associations with the presence of at least mild AR, which persisted after controlling for age and gender. Increased ascending aorta dimension is associated with AR in patients after repair of TOF. LVEF was also low in the group of patients with relevant AR compared to those without, suggesting even mild to moderate AR may contribute to LV dysfunction in these patients. Enlarged ascending aorta may be an indication for precise quantification of regurgitant fraction with MRI, since symptomatic patients may need aortic valve repair when moderate regurgitation is present.

Transfemoral valve-in-valve implantation for degenerated bioprosthetic aortic valves using the new balloon-expandable Edwards Sapien 3 valve.

Surgical aortic bioprosthetic valves deteriorate 10 to 20 years after operation. Valve-in-valve implantation with first generation transcatheter aortic valve implantation (TAVI) devices has shown to be feasible. We report a first case series with the new Edwards Sapien 3 valve for transfemoral aortic valve-in-valve implantation. Nine patients underwent valve-in-valve-TAVI with the Edward Sapien 3 valve. Seven patients presented with severe aortic stenosis and two patients with severe aortic insufficiency of surgical aortic bioprosthesis. Procedures were performed in local anaesthesia under fluoroscopic guidance with pre-procedural 256 multislice computed tomography for procedural planning. In all patients the Edwards Sapien 3 was successfully implanted decreasing the mean echocardiographic gradient from 42 ± 22mmHg to 18 ± 7mmHg (p < 0.01). Device success according to VARC 2 criteria was achieved in 8 out of 9 patients. There was no death, coronary obstruction, use of second valve or need for post-dilation. Furthermore there were no access-site complications, no minor or major bleedings or vascular injury. Two patients required pacemaker implantation within the first 7 days after valve-in-valve TAVI. Post-procedural echocardiography demonstrated no or trace aortic regurgitation. Early safety events within 30 days according to VARC-2 definition occurred in 1 patient. The Edwards Sapien 3 valve for treatment of failed surgical bioprostheses is feasible and is associated with no relevant post-procedural aortic regurgitation and a low risk of access site complications. © 2016 Wiley Periodicals, Inc.

Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve.

We aimed to demonstrate the feasibility and investigate the safety of a novel, self-expanding trans-catheter heart valve in a selected patient population with severe aortic stenosis. Between January and September 2013, a total of 21 patients with symptomatic severe aortic stenosis were eligible for transcatheter aortic valve implantation (TAVI) with the self-expanding NVT Allegra bioprosthesis (New Valve Technology, Hechingen, Germany) at two cardiovascular centres. Patients were elderly (age 83.8±4 years), predominantly female (95.2%), and all were considered to be at prohibitive risk for surgical aortic valve replacement (logistic EuroSCORE 30.4±11%). Procedural and device success was achieved in 95.2% and 85.7%, respectively. Echocardiographic assessment at discharge showed favourable haemodynamic results with a reduction of the mean transvalvular aortic gradient from 48.0±21 mmHg to 8.9±3 mmHg. In the majority of patients (90.5%), none or trace aortic regurgitation was recorded. Permanent pacemaker implantation was required in 23.8% of patients within the first 30 days of follow-up. Apart from one procedural death, no other serious adverse events were observed during the periprocedural period. TAVI with the NVT Allegra system was highly effective in alleviating symptoms and reducing NYHA functional class at 30-day follow-up. The first-in-human experience with the NVT Allegra transcatheter heart valve prosthesis was associated with a high rate of procedural success. Furthermore, the NVT Allegra bioprosthesis was able to achieve favourable haemodynamic results and effectively alleviate symptoms at 30-day follow-up. The larger, multicentre NAUTILUS study will provide further information on the safety and efficacy of this novel, second-generation transcatheter aortic bioprosthesis.

Abstract 13606: Platelet Activation is Less Enhanced in the New Balloon Expandable Edwards Sapien 3 Valve Compared to Its Predecessor Model (Edwards Sapien XT)

Aim of the study: Stroke and thromboembolic events after transfemoral aortic valve replacement (TAVR) continue to be a problem. The aim of our study was to compare platelet aggregation (Agg) and platelet activation (PA) observed with two different catheter valves, the ESV-XT and the newer ESV-3 valve in patients (pts) undergoing TAVR on dual antiplatelet therapy (DAPT). Methods and results: 174 pts with severe aortic stenosis and high surgical risk underwent successfully TAVR (60 ESV-XT; 114 ESV-3). Platelet Agg and PA (CD62P expression) were evaluated before and for the following 3 days after TAVR under DAPT. Platelet Agg was inhibited to the same extent in both valve types and there was no significant difference in platelet drop between both valve types between day 0 and day 3 [ESV-XT versus ESV-3: median (25th-75th percentile): platelet count (x 1000 ): 55 (42-74) versus 61(42-93), p=0.280]. However there was an enhanced CD62P expression directly after TAVR with the ESV-XT compared to the ESV-3 [CD62P (MIF): 7.4 (6.8-8.6) versus 6.6 (6-7.9), p=0.014 ]. Surface expression of platelet CD62P was associated with the occurrence of residual aortic regurgitation (AR) and was significantly higher in pts with residual AR [ CD62P (Mild AR) versus CD 62 P (no or trace AR): 7.9 (7.3-9.1) versus 7.1 (6.4 -8.0), p &lt; 0.001)]. Conclusion: Although platelet inhibition was similar in both valve types, platelet activation was significantly enhanced in pts with the ESV-XT compared to the ESV-3 valve and was associated to the amount of residual AR which was significantly reduced by ESV-3, which may have implications for thromboischemic events following TAVR procedure.

Clinical outcomes of combined aortic root reimplantation technique and total arch replacement.

The goal of this study was to evaluate early and late outcomes of combined valve-sparing aortic root replacement and total arch replacement (TAR). From October 1999 to May 2014, 195 patients underwent valve-sparing operations using the David reimplantation technique. Thirty-one patients underwent combined TAR for aortic regurgitation (AR) with extended aortic aneurysm from the aortic root to the aortic arch. Aetiologies included acute type A aortic dissection in 12 cases, chronic aortic dissection in 8 cases and non-dissecting aneurysm in 11 cases. There were 9 patients with Marfan syndrome. The preoperative severity of AR was mild in 4, moderate in 16 and severe in 11. Even though half of those were emergent operations for acute aortic dissection, preoperative haemodynamic conditions were stable in all patients. No hospital deaths occurred. Postoperative complications included prolonged mechanical ventilation (>48 h) in 1 case and re-exploration for bleeding in 2 cases. Other complications, such as neurological dysfunction or low cardiac output syndrome, were not observed. At hospital discharge, 2 patients had mild AR, 22 had trace AR and 7 had no AR. During follow-up, 2 patients had moderate AR, 7 had mild AR, 18 had trace AR and 3 had no AR. Follow-up was completed in 95.1% of patients, and the mean follow-up period was 60.5 ± 9.1 months. No late death and thromboembolic complication occurred during follow-up. One patient required reoperation for AR. Freedom from reoperation at 5 and 10 years was 100 ± 0 and 83.3 ± 3.5%, respectively. Freedom from moderate or severe AR at 3 and 5 years was 83.3 ± 3.5 and 83.3 ± 3.5%, respectively. Early outcomes of combined aortic root reimplantation and TAR were satisfactory and provided excellent freedom from thromboembolic complication. The rate of freedom from reoperation during long-term follow-up was acceptable. Further follow-up is required to evaluate this procedure.

Clinical impact of aortic regurgitationafter transcatheter aorticvalve replacement: insights into the degree and acuteness of presentation.

The aim of this study was to determine the impact of the degree of residual aortic regurgitation (AR) and acuteness of presentation of AR after transcatheter aortic valve replacement (TAVR) on outcomes. The degree of residual AR after TAVR leading to excess mortality remains controversial, and little evidence exists on the impact of the acuteness of presentation of AR. A total of 1,735 patients undergoing TAVR with balloon-expandable or self-expanding valves were included. The presence and degree of AR were evaluated by transthoracic echocardiography; acute AR was defined as an increase in AR severity of ≥1 degree compared with pre-procedural echocardiography. Residual AR was classified as mild in 761 patients (43.9%) and moderate to severe in 247 patients (14.2%). The presence of moderate to severe AR was an independent predictor of mortality at a mean follow-up of 21 ± 17 months compared with none to trace (adjusted hazard ratio [HR]: 1.81, 95% confidence interval [CI]: 1.32 to 2.48; p < 0.001) and mild AR (adjusted HR: 1.68, 95% CI: 1.27 to 2.24; p < 0.001) groups. There was no increased risk in patients with mild AR compared with those with none to trace AR (p = 0.393). In patients with moderate to severe AR, acute AR was observed in 161 patients (65%) and chronic AR in 86 patients (35%). Acute moderate to severe AR was independently associated with increased risk of mortality compared with none/trace/mild AR (adjusted HR: 2.37, 95% CI: 1.53 to 3.66; p < 0.001) and chronic moderate to severe AR (adjusted HR: 2.24, 95% CI: 1.17 to 4.30; p = 0.015) [corrected]. No differences in survival rate were observed between patients with chronic moderate to severe and none/trace/mild AR (p > 0.50). AR occurred very frequently after TAVR, but an increased risk of mortality at ∼2-year follow-up was observed only in patients with acute moderate to severe AR.

Absence of significant aortic regurgitation seven years after closure of patent foramen ovale

BackgroundIt has been suggested that there is an increase in aortic regurgitation (AR) in the short and medium term after percutaneous closure of patent foramen ovale (PFO). The aim of this study is to determine the long-term effect of percutaneous closure of PFO on the prevalence of AR. MethodsPatients with cryptogenic stroke or transient ischemic attack who had undergone percutaneous closure of PFO more than five years before the study were invited to an echocardiographic examination. ResultsOut of 83 invited patients, 64 accepted the invitation and were examined with echocardiography. Mild AR was found in one patient (2%), but this was already evident in the patient's echocardiographic result before PFO closure. Trace AR was detected in 11 patients (17%). No case of moderate or severe AR was detected. Patients with AR were more often hypertensive (six out of 12 patients with AR, compared to nine of the 52 without AR, p = 0.025), and the indexed sinus of Valsalva was larger in patients with AR (18.6 mm/m2, SD 1.6, as compared to 17.3 mm/m2, SD 1.6, p = 0.02). ConclusionIn this long-term study with a minimum follow-up of 5.6 years and a mean of 7.1 years, we found negligible levels of AR. Where present, AR was associated with hypertension and mild dilatation of the aortic root, but there was no indication that device closure per se increased the risk of developing AR.

Bicuspid aortic valve repair by complete conversion from “raphe'd” (type 1) to “symmetric” (type 0) morphology

An anterior cusp with a median raphe and false commissure is the most common bicuspid aortic valve phenotype. The cusp is typically restricted and its annular attachment malpositioned, often resulting in significant aortic regurgitation. A novel valve repair strategy was designed to create a symmetric valve to improve both function and durability. The technique involves converting the valve into a "symmetric" bicuspid valve by resection of the median raphe, with shortening of the anterior cusp's leading edge; resection of the false commissure with complete anterior annular detachment; enlargement, reinforcement, and translocation of the anterior cusp deeper into the left ventricular outflow tract; and valve-sparing aortic root replacement with concomitant annuloplasty. A total of 32 patients with a bicuspid valve, aortic insufficiency, and aortic dilatation have undergone valve repair with root replacement. No operative deaths or strokes occurred, and no permanent pacemakers were required. Thirteen patients underwent complete conversion from "raphe'd" to "symmetric" morphology; the others underwent less complex repairs without translocation. The postoperative transvalvular gradients remained normal. Freedom from grade >1+ aortic regurgitation and valve-related reoperation was 100%. All 13 symmetric conversion patients have continued to have no or trace aortic regurgitation (grade < 1+) at a mean follow-up of 2.9 years (range, 0.4-7). Repair of the common, "raphe'd" bicuspid phenotype by reconfiguration into "symmetric" morphology is both feasible and desirable, regardless of the degree of preoperative aortic regurgitation. This repair strategy appears durable at the mid-term without evolving signs of deterioration or stenosis, offering a potentially superior option over prosthetic root replacement for younger patients.