Paravalvular Aortic Regurgitation Research Articles

Intraoperative 2D and 3D transoesophageal echocardiographic predictors of aortic regurgitation after transcatheter aortic valve implantation

BackgroundPost-procedural aortic regurgitation (AR) has been described in a large number of patients receiving transcatheter aortic valve implantation (TAVI).ObjectiveThe aim of this study was to examine the intraoperative 2-dimensional (2D)...

Feasibility of the Engager aortic transcatheter valve system using a flexible over-the-wire design

The aim was to investigate the safety and feasibility of the redesigned Engager™ transcatheter aortic valve implantation (TAVI) system. Transapical aortic valve implantation with the Engager™ valve prosthesis was intended in 11 patients, and performed in 10. Endpoints were defined according to the valve academic research consortium recommendations for reporting outcomes of TAVI in clinical trials. All 10 patients were implanted successfully. No devicerelated or delivery system complications like coronary obstruction or aortic dissection emerged. One patient (10%) died from non-device-related reasons at post-operative day 23 of multi-organ failure. The invasively measured peak-to-peak gradient after valve implantation was 7.1 ± 3.5 mmHg. In 90%, there was no or only trivial (≤grad I) aortic regurgitation due to paravalvular leakage. In 10% of the patients, aortic regurgitation grade I-II was observed. At 30-day follow up, the mean gradient was 15.6 ± 4.9 mmHg, and no more than a mild transvalvular and paravalvular aortic regurgitation was seen as assessed by transthoracic echocardiography. Application of the Engager™ TAVI system is safe and feasible. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and was successful in all patients. No device or delivery-system-related complications emerged. Safety and feasibility endpoints were met. Good results concerning the aortic valve performance after implantation and at 30-day follow up were ascertained. These results encouraged the start of a European Pivotal trial including patients to date.

Transcatheter Aortic Valve Implantation with Corevalve®: A New Mode of Therapy for Surgically High-Risk Patients with Severe or Critical Aortic Stenosis

INTRODUCTION: Aortic Stenosis (AS) is a common and life-threatening disease that presents with angina, heart failure, or syncope. Internationally, transcatheter aortic valve implantation (TAVI) has become accepted as a less invasive percutaneous alternative to surgical replacement for high-risk patients with severe or critical AS. OBJECTIVE: This paper presents the first TAVI case performed at The Heart Institute of the Chinese General Hospital and Medical Center, and reports the first valve-in-valve TAVI case in the Philippines. CASE: An 87-year old diabetic male patient presented with congestive heart failure and a history of coronary artery bypass grafting, chronic obstructive pulmonary disease, and chronic renal insufficiency. A 2-D echocardiogram (2DE) revealed severe AS with normal left ventricular function. Left heart catheterization confirmed severe AS and showed severe triple vessel coronary artery disease with continued patency of all bypass grafts. Surgical aortic valve replacement was recommended but deemed too high-risk. Ancillary studies revealed that the patient was a viable candidate for TAVI. A 29-mm Corevalve® was implanted, with subsequent moderate to severe paravalvular aortic regurgitation (AR). A second 29-mm Corevalve® was implanted within the first Corevalve®. The patient tolerated the procedure well with marked improvement in symptoms. A repeat 2DE showed normal functioning bioprosthetic valve with minimal AR. CONCLUSION: TAVI is an alternative mode of therapy in carefully selected surgically high-risk patients with severe or critical AS. Careful and thorough pre-procedural measurements are key for proper valve sizing. Post TAVI calculation of the aortic regurgitation index is important in determining the short- and long term success of the procedure.

Transcatheter Valve-In-Valve Implantation for Failed Balloon-Expandable Transcatheter Aortic Valves

This study sought to evaluate outcomes after implantation of a second transcatheter heart valve (THV-in-THV) for acute THV failure. Aortic regurgitation after transcatheter aortic valve replacement (TAVR) may be valvular due to prosthetic leaflet dysfunction or paravalvular due to poor annular sealing. Patients undergoing aortic balloon-expandable TAVR at 3 centers were prospectively evaluated at baseline, intraprocedurally, at hospital discharge, and annually. Of 760 patients undergoing TAVR, 21 (2.8%) received a THV-in-THV implant due to acute, severe regurgitation. Aortic regurgitation was paravalvular in 18 patients and transvalvular in the remaining 3 patients. THV-in-THV implantation was technically successful in 19 patients (90%) and unsuccessful in 2 patients (10%), who subsequently underwent open heart surgery. Mortality at 30 days and 1 year was 14.3% and 24%, respectively. After successful THV-in-THV, mean aortic valve gradient fell from 37 ± 12 mm Hg to 13 ± 5 mm Hg (p < 0.01); aortic valve area increased from 0.64 ± 0.14 cm(2) to 1.55 ± 0.27 cm(2) (p < 0.01); and paravalvular aortic regurgitation was none in 4 patients, mild in 13 patients, and moderate in 2 patients. At 1-year follow-up, 1 patient had moderate and the others had mild or no paravalvular leaks. The mean transvalvular gradient was 15 ± 4 mm Hg, which was higher than in patients undergoing conventional TAVR (11 ± 4 mm Hg, p = 0.02). THV-in-THV implantation is feasible and results in satisfactory short- and mid-term outcomes.

Impact of Aortic Regurgitation After Transcatheter Aortic Valve Implantation: Results From the REVIVAL Trial

Understanding the severity of aortic regurgitation (AR) after transcatheter aortic valve implantation, its impact on left ventricular (LV) structure and function, and the structural factors associated with worsening AR could lead to improvements in patient selection, implantation technique, and valve design. Initial studies in patients at high risk of surgical aortic valve replacement have reported both central valvular and paravalvular AR after transcatheter aortic valve implantation. Transthoracic echocardiograms were quantified from 95 patients in the REVIVAL (TRanscatheter EndoVascular Implantation of VALves) trial. Transthoracic echocardiograms were obtained before implantation of the Edwards-Sapien valve (Edwards Lifesciences, Irvine, California) and thereafter at selected intervals. Measurements included LV internal diameters and volumes, ejection fraction, aortic valve area, and the degree of aortic regurgitation. Measures of degree of native leaflet mobility, thickness, and calcification, as well as left ventricular outflow tract, aortic annulus, and aortic root diameters were also made. Eighty-four patients remained after 11 were excluded; 26 (29.8%) died over a period of 3 years. At 24 h post-implantation, 75% had some degree of AR, mostly paravalvular. By 1 year, the mean AR grade increased slightly, but not significantly (1.1 ± 0.8 to 1.3 ± 0.9), and all measures of LV structure and function improved (LV ejection fraction, 50.7 ± 16.1% to 59.4 ± 14.0%). Native aortic leaflet calcification and annulus diameter correlated significantly with the severity of AR at 1 year (p < 0.05). AR after transcatheter aortic valve implantation is frequent but is rarely more than mild. Although AR progresses, it is not associated with a harmful impact on LV structure and function over the first year. Native valve calcification and aortic annulus diameter influence the degree of AR at 6 months.

Predictive Factors, Efficacy, and Safety of Balloon Post-Dilation After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve

This study sought to evaluate the predictive factors, effects, and safety of balloon post-dilation (BPD) for the treatment of significant paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI). Very few data exist on BPD after TAVI with a balloon-expandable valve. A total of 211 patients who underwent TAVI with a balloon-expandable valve were included. BPD was performed after TAVI if paravalvular AR ≥ 2 was identified by transesophageal echocardiography. Clinical events and echocardiographic data were prospectively recorded, and median follow-up was 12 (6 to 24) months. BPD was performed in 59 patients (28%), leading to a reduction in at least 1 degree of AR in 71% of patients, with residual AR <2 in 54% of the patients. The predictors of the need for BPD were the degree of valve calcification and transfemoral approach, with valve calcification volume >2,200 and >3,800 mm(3) best determining the need for and a poor response to BPD, respectively. Patients who underwent BPD had a higher incidence of cerebrovascular events at 30 days (11.9% vs. 2.0%, p = 0.006), with most (83%) events within the 24 h after the procedure occurring in patients who had BPD. No significant changes in valve area or AR degree were observed at follow-up in BPD and no-BPD groups. BPD was needed in about one-fourth of the patients undergoing TAVI with a balloon-expandable valve and was successful in about one-half of them. A higher degree of valve calcification and transfemoral approach predicted the need for BPD. BPD was not associated with any deleterious effect on valve function at mid-term follow-up, but a higher rate of cerebrovascular events was observed in patients who had BPD.

Prosthesis/annulus discongruence assessed by three-dimensional transoesophageal echocardiography: A predictor of significant paravalvular aortic regurgitation after transcatheter aortic valve implantation

Paravalvular aortic regurgitation (AR) is common after transcatheter aortic valve implantation (TAVI). This study aimed to assess the prosthesis/aortic annulus discongruence by three-dimensional (3D) transoesophageal (TOE) planimetry of aortic annulus and its impact on the occurrence of significant AR after TAVI. We included 33 patients who underwent TAVI with a balloon expandable device for severe aortic stenosis. To appraise the prosthesis/annulus discongruence, we defined a 'mismatch index' expressed as: annulus area - prosthesis area. The aortic annulus area was planimetered with 3D TOE, and approximated by circular area formula (π r(2)) using annulus diameter obtained by two-dimensional (2D) TOE. After TAVI, 13 patients (39.3%) developed significant AR (≥2/4). The occurrence of significant AR was associated to the 3D planimetered annulus area (P = 0.04), and the 'mismatch index' obtained through 3D planimetered annulus area (P = 0.03), but not to 'mismatch index' derived of 2D annulus diameter. In multivariate analysis, 'mismatch index' for 3D planimetered annulus area was the only independent predictor of significant AR (odds ratio: 10.614; 95% CI: 1.044-17.21; P = 0.04). The area under the receiver operating characteristic curve for the 'mismatch index' by the 3D planimetered annulus area was 0.76 (95% CI: 0.54-0.92), whereas for 'mismatch index' obtained by the 2D circular area was 0.36 (95% CI: 0.17-0.55). Using the 3D planimetered annulus area as the reference parameter to decide the prosthetic size, the choice would have been different in 21 patients (63%). Three-dimensional TOE planimetry of aortic annulus improves the assessment of prosthesis/annulus discongruence and predicts the appearance of significant AR after TAVI.

Transapical transcatheter aortic valve implantation using the JenaValve system: acute and 30-day results of the multicentre CE-mark study

Transcatheter aortic valve implantation (TAVI) has shown promising results in patients with severe aortic stenosis (AS) at high risk for conventional heart surgery. The safety and efficacy of transapical aortic valve implantation using the JenaValve™, a second-generation TAVI device, were evaluated. The system consists of a tested porcine root valve mounted on a nitinol stent with feeler-guided positioning and clip fixation on the diseased leaflets. This multicentre, prospective, single-arm study, conducted at seven German sites, enrolled 73 patients (mean age 83.1 ± 3.9), European System for Cardiac Operative Risk Evaluation (EuroSCORE) (28.4 ± 6.5%) of whom 67 patients underwent elective TAVI. Three sizes were used for annular diameters up to 23 mm (n = 21), 25 mm (n = 31) and 27 mm (n = 15). Clinical and echocardiographic evaluations were performed at baseline, post-procedure, discharge and 30 days, and also at 3, 6 and 12 months. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints were procedural success, major adverse cardiac and cerebrovascular events and echocardiographic performance. TAVI with the JenaValve™ device was successful in 60 patients (procedural success rate 89.6%). The overall mortality at 30 days was 7.6%. Conversion to surgery was necessary in four patients (6%), two patients underwent valve-in-valve implantations (3%), one patient was withdrawn per protocol after conversion to TAVI using a balloon-expandable valve (1.5%) since the patient did not receive the study device. Perioperative stroke occurred in two cases (3%). Pacemaker implantation for new onset conduction disorders was necessary in six patients (9.1%). No ostial coronary obstructions were seen. Post-procedure TAVI resulted in favourable reduction of mean transvalvular gradients (40.6 ± 15.9 vs. 10.0 ± 7.2 mmHg, P < 0.0001) and increase in valve opening area (0.7 ± 0.2 vs. 1.7 ± 0.6 cm², P < 0.0001). The majority of successfully treated patients revealed no or minimal paravalvular aortic regurgitation (86.4%); none of the patients had severe post-procedural regurgitation (>2+). Transapical JenaValve™ implantation was safe and effective in the treatment of severe AS in elderly patients at high risk for surgery. Active clip fixation on the native leaflets and anatomically correct feeler-guided positioning led to good functionality and prevented ostial coronary impairment. Implantation without the need for rapid pacing prevented haemodynamic compromise during valve implantation.

Why not "Simplify" TAVI?

, FACC, FSCA Aortic stenosis among the elderly is associated with a substantial increase in morbidity and mortality once symptoms such as angina, syncope, or heart failure develop. Since 2002, transcatheter aortic valve implantation (TAVI) has been established as an emerging therapeutic approach for patients with unacceptable surgical risk and a less invasive alternate treatment option for patients at high risk for openheart surgery. Meanwhile, more than 60,000 patients underwent TAVI procedures worldwide and the dramatic growth in TAVI will possibly continue over the next years. New technology advances promise to simplify TAVI and to improve outcome by reducing the rate of TAVI-specific issues such as stroke, paravalvular aortic regurgitation, acute kidney injury, vascular complications, and conduction disturbances. Mendiz and co-workers report about their initial

Super size me? Annular size and paravalvular leak after TAVR

Paravalvular aortic regurgitation (PAR) after transcatheter aortic valve replacement is common and independently associated with increased morbidity and mortality. The determinants of PAR are uncertain, but new data extend our understanding, and a simple practice change in preprocedural imaging could help dramatically to reduce the incidence of this important complication.

Aortic valve calcium load before TAVI: Is it important?

Aortic valve calcium load before TAVI: Is it important?

3-Dimensional Aortic Annular Assessment by Multidetector Computed Tomography Predicts Moderate or Severe Paravalvular Regurgitation After Transcatheter Aortic Valve Replacement: A Multicenter Retrospective Analysis

This study sought to analyze multidetector computed tomography (MDCT) 3-dimensional aortic annular dimensions for the prediction of paravalvular aortic regurgitation (PAR) following transcatheter aortic valve replacement (TAVR).Moderate or severe PAR after TAVR is associated with increased morbidity and mortality.A total of 109 consecutive patients underwent MDCT pre-TAVR with a balloon expandable aortic valve. Differences between transcatheter heart valve (THV) size and MDCT measures of annular size (mean diameter, area, and circumference) were analyzed concerning prediction of PAR. Patients with THV malposition (n = 7) were excluded. In 50 patients, MDCT was repeated after TAVR to assess THV eccentricity (1 - short diameter/long diameter) and expansion (MDCT measured THV area/nominal THV area).Moderate or severe PAR (13 of 102) was associated with THV undersizing (THV diameter - mean diameter = -0.7 ± 1.4 mm vs. 0.9 ± 1.8 mm for trivial to mild PAR, p < 0.01). The difference between THV size and MDCT annular size was predictive of PAR (mean diameter: area under the curve [AUC]: 0.81, 95% confidence interval [CI]: 0.68 to 0.88; area: AUC: 0.80, 95% CI: 0.65 to 0.90; circumference: AUC: 0.76, 95% CI: 0.59 to 0.91). Annular eccentricity was not associated with PAR (AUC: 0.58, 95% CI: 0.46 to 0.75). We found that 35.3% (36 of 102) and 45.1% (46 of 102) of THVs were undersized relative to the MDCT mean diameter and area, respectively. THV oversizing relative to the annular area was not associated with THV eccentricity or underexpansion (oversized vs. undersized THVs; expansion: 102.7 ± 5.3% vs. 106.1 ± 5.6%, p = 0.03; eccentricity: median: 1.7% [interquartile range: 1.4% to 3.0%] vs. 1.7% [interquartile range: 1.1% to 2.7%], p = 0.28).MDCT-derived 3-dimensional aortic annular measurements are predictive of moderate or severe PAR following TAVR. Oversizing of THVs may reduce the risk of moderate or severe PAR.

Cross-Sectional Computed Tomographic Assessment Improves Accuracy of Aortic Annular Sizing for Transcatheter Aortic Valve Replacement and Reduces the Incidence of Paravalvular Aortic Regurgitation

In an effort to define the gold standard for annular sizing for transcatheter aortic valve replacement (TAVR), we sought to critically analyze and compare the predictive value of multiple measures of the aortic annulus for post-TAVR paravalvular (PV) regurgitation and then assess the impact of a novel cross-sectional computed tomographic (CT) approach to annular sizing. Recent studies have shown clear discrepancies between conventional 2-dimensional (2D) echocardiographic and CT measurements. In terms of aortic annular measurement for TAVR, such findings have lacked the outcome analysis required to inform clinical practice. The discriminatory value of multiple CT annular measures for post-TAVR PV aortic regurgitation was compared with 2D echocardiographic measures. TAVR outcomes with device selection according to aortic annular sizing using a traditional 2D transesophageal echocardiography-guided or a novel CT-guided approach were also studied. In receiver-operating characteristic models, cross-sectional CT parameters had the highest discriminatory value for post-TAVR PV regurgitation: This was with the area under the curve for [maximal cross-sectional diameter minus prosthesis size] of 0.82 (95% confidence interval: 0.69 to 0.94; p < 0.001) and that for [circumference-derived cross-sectional diameter minus prosthesis size] of 0.81 (95% confidence interval: 0.7 to 0.94; p < 0.001). In contrast, traditional echocardiographic measures were nondiscriminatory in relation to post-TAVR PV aortic regurgitation. The prospective application of a CT-guided annular sizing approach resulted in less PV aortic regurgitation of grade worse than mild after TAVR (7.5% vs. 21.9%; p = 0.045). Our data lend strong support to 3-dimensional cross-sectional measures, using CT as the new gold standard for aortic annular evaluation for TAVR with the Edwards SAPIEN device.

Doppler haemodynamics and effective orifice areas of Edwards SAPIEN and CoreValve transcatheter aortic valves

Transcatheter aortic valve implantation (TAVI) is a new therapy for severe aortic stenosis in high-risk patients. So far, no reference values for the echocardiographic assessment of this new class of heart valves have been established. The aim of our study was to determine Doppler haemodynamics and the effective orifice area (EOA). We retrospectively analysed the earliest transthoracic echocardiographic examinations of 146 stable patients after successful TAVI (median 8±20 days). Doppler examinations were analysed for peak instantaneous velocity, peak, and the mean systolic gradient. EOA was determined using the continuity equation. Patients with severe paravalvular aortic or mitral valve regurgitation were excluded. The overall peak instantaneous velocity (n=146) was 2.0±0.4 m/s with a peak systolic gradient of 17.1±7.4 mmHg and a mean gradient of 9.3±4.5 mmHg. The mean EOA was 1.82±0.43 cm2 with an indexed EOA of 1.0±0.27 cm2/m2. In general, all prostheses showed similar values-with the exception of the Edwards Sapien 23 mm which was associated with higher velocities and peak pressure gradients. Our study establishes the normal range for Doppler haemodynamics of four transcatheter aortic valve prostheses. Compared with previously published data of surgically implanted bioprostheses percutaneous valves tend to have similar EOA values but lower mean peak velocities and pressure gradients. In comparison with physiological haemodynamics; however, this new class of heart valves is still associated with a mild obstruction.

Predictores clínicos y ecocardiográficos de regurgitación aórtica periprotésica tras el implante de la prótesis aórtica percutánea CoreValve

PurposeThe purpose of this study was to determine the clinical and echocardiographic predictors of aortic regurgitation of at least of grade 2 after transcatheter aortic valve implantation (TAVI). MethodsFrom a total of 88 patients with severe aortic stenosis treated with TAVI with the Medtronic CoreValve® bioprosthesis, we analysed 79 consecutive procedures in which we obtained comprehensive echocardiographic examinations at baseline and at discharge. Aortic regurgitation (AR) was assessed by transthoracic echocardiography according to current echocardiography guidelines. ResultsAt discharge, paravalvular AR was absent in 22 patients (28%), grade 1/4 in 29 (37%), 2/4 in 23 (29%), and 3/4 5 (6%). Occurrence of AR ≥2/4 was related to gender (64% males vs. 36% females, P=.02), larger sino-tubular junction (25±5 vs. 23±3mm; P<.05), aortic sinus diameter (31±4 vs. 29±4; P<.05) and asymmetric calcification of the aortic annulus (61% vs 39%; P<.05). ConclusionsThe occurrence of aortic regurgitation ≥2/4 was more frequent in males, with a large aortic root and asymmetric calcification aortic annulus.

Temporal changes in left ventricular function and paravalvular aortic regurgitation after transcatheter aortic valve implantation: a cardiac magnetic resonance imaging study

Background Transcatheter aortic valve implantation (TAVI) has been established as a therapeutic alternative in patients with severe aortic stenosis at high risk for surgery. Paravalvular aortic regurgitation (AR) is frequent after TAVI. Yet, little data is available about temporal changes of AR and the impact of TAVI on left ventricular (LV) function and dimensions. We used cardiac MRI to evaluate LV function, volumes and mass, the occurrence and degree of AR in the early and medium-term follow-up after TAVI.

Case of the mysterious signal

A 76-year-old man underwent direct aortic CoreValve® (Medtronic Inc., Minneapolis, MN, USA). After successful implantation of the CoreValve, a transoesophageal echocardiogram showed mean and peak gradients of 5 and 14 mmHg, respectively, along with mild valvular and paravalvular aortic regurgitation. Prior to discharge from the hospital, a transthoracic echocardiogram …

Transcatheter Aortic Valve-in-Valve-in-Valve Implantation for a Failed Xenograft

A 78-year-old gentleman with a diagnosis of symptomatic severe xenograft aortic stenosis with multiple comorbidities was referred for transcatheter aortic valve implantation, that is, a "valve-in-valve" procedure. Transcatheter aortic valve implantation was performed by transapical approach using a balloon-expandable bioprosthesis. During valve deployment, the prosthesis moved toward the left ventricle and a second balloon-expandable valve was implanted within the first one-a "valve-in-valve-in-valve" to avoid further ventricular embolization of the first bioprosthesis. Echocardiography at hospital discharge showed a residual mean transvalvular gradient of 17 mm Hg and trivial paravalvular aortic regurgitation. At 1 year follow-up, the patient was in New York Heart Association functional class II.

Aortic Annular Eccentricity Index Assessed on Computed Tomography is Related to Paravalvular Aortic Regurgitation Post Transcatheter Aortic Valve Implantation With CoreValve

Aortic Annular Eccentricity Index Assessed on Computed Tomography is Related to Paravalvular Aortic Regurgitation Post Transcatheter Aortic Valve Implantation With CoreValve

Transcatheter Aortic Valve Implantation: Early Experience in Korea

Background and ObjectivesTranscatheter aortic valve implantation (TAVI) was recently introduced in Korea. The present report describes the experience of early TAVI cases.Subjects and MethodsBetween March, 2010 and October, 2011, 48 patients with severe symptomatic aortic stenosis (AS) were screened at the Asan Medical Center to determine their suitability for surgical intervention. Of these, 23 were considered unsuitable and underwent TAVI. Procedural success rates, procedure-related complications, and clinical outcomes were evaluated in the TAVI patients.ResultsTransfemoral (n=20) or transapical (n=3) TAVI was performed. The mean age of patients was 75.9±5.4 years and 57% were females. The mean logistic European System for Cardiac Operative Risk Evaluation was 25.6±5.1%. Implantation was successful in 22 patients (19 transfemoral, three transapical). After successful implantation, the mean aortic valve area increased from 0.68±0.14 cm2 to 1.45±0.33 cm2. There were no procedure-related complications or mortality. The patients showed no paravalvular aortic regurgitation with ≥ moderate degree and remained stable without progression during follow-up. During follow-up (interquartile range, 1.1-12.9), all patients were alive without any occurrence of valve failure.ConclusionTAVI procedure is feasible in patients with inoperative symptomatic AS leading to hemodynamic and clinical improvement. With accumulation of experience, proper patient selection and development of device technologies, TAVI should decrease adverse events and expand the indications in the near future.