Sequential TAV-in-TAV Resolves LVOT Pseudoaneurysm-Related Paravalvular Leak.

Paravalvular leak (PVL) is a complication of transcatheter aortic valve replacement. Despite its marked clinical impact, no previous study has reported how PVL affects the intraventricular fluid dynamics. This study aims to delineate vortex interaction between PVL and transmitral flow and the influence of PVL orifice location on intraventricular fluid dynamics using Echocardiographic Particle Image Velocimetry. Three different conditions of no PVL, anterior PVL and posterior PVL were experimentally studied and clinically compared. Circulation, impulse, kinetic energy (KE) and change in KE (ΔKE) were calculated. As well, vortex formation analyses and streamline description were performed to study vortex interactions. The anterior PVL jet streamed into the LV and interfered with the transmitral flow. Posterior PVL jet formed a large clockwise vortex and collided with transmitral flow, which resulted in flow disturbance. Compared to no PVL condition, average circulation, impulse, KE and ΔKE increased in presence of PVL. In conclusion, we found that PVL jets lead to abnormal vortex formation that interfere with natural advancement of transmitral flow, and negatively affect the LV fluid dynamics parameters. PVL orifice location strongly affects the intraventricular vortex formation, and posterior PVL may have more negative effects compared to anterior PVL.

Paravalvular Leak After Transcatheter Aortic Valve Implantation: Results From 3600 Patients.

Paravalvular leak (PVL) is a relatively rare, but serious complication occurring in up to 10% of patients after prosthetic aortic valve replacement and in up to 17% of patients after prosthetic mitral valve replacement. Up to 5% of patients will present with symptoms of congestive heart failure or mechanical haemolytic anaemia due to PVL and need further surgical or interventional treatment. Surgical repair is often technically challenging and carries a high mortality and morbidity risk. Catheter-based closure of PVL has emerged as an alternative approach especially for patients with relevant comorbidities at high surgical risk. Interventional closure of PVL is a complex procedure, which needs to be performed by an experienced team of interventional cardiologist, echocardiographer and anesthesiologist. To date available clinical results are promising showing low complication rates and high technical or clinical success rates of catheter-based closure of PVL (60-90%). Compared to surgical closure of PVL lower mortality rates (30-days mortality rate: 4,6%) have been documented in patients treated by catheter-based closure of PVL in clinical practice. Therefore interventional closure seems to be a promising option, which need to be discussed with every symptomatic patient suffering from PVL prior to therapeutical decision making. To date only sparse clinical data is available regarding indication and clinical outcome of patients undergoing catheter-based PVL in clinical practice. Therefore interventional closure of PVL should be limited to experienced interventional cardiologist at present. All patients treated should further be enrolled into a clinical registry to evaluate the safety and efficacy of catheter-based closure of PVL in clinical practice.

Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort).

Valve oversizing has been associated with reduced paravalvular leaks (PVL) and valve migration risk. However, no optimal cut-off oversizing value has been defined for the Evolut system (Medtronic). The aim of this study was to assess the relationship between the degree of oversizing and moderate-to-severe PVL and determine the optimal oversizing cut-off value. We conducted a multicenter study that included 740 consecutive patients with multidetector computed tomography (CT) data. Valve size was selected according to manufacturer recommendations, with oversizing ranging from 10% to 30%. The primary endpoint was moderate-to-severe PVL. The median age was 84 years (79-87 years), with 58.4% women, and a median EuroSCORE II of 4.1% (2.4-7.3%). Moderate-to-severe PVL was observed in 7.0% of the patients. An inverse relationship was found between oversizing and both PVL (11.3%, 8.6%, 5.4%, and 2.7% for quartiles Q1 to Q4; P = .007) and the need for post-dilation (P = .016). The multivariable analysis showed an association between oversizing and PVL (OR: 0.915 for each 1%-increase, P = .002). The optimal oversizing cut-off value to predict PVL was 20%, and PVL was significantly higher in patients with oversizing less than 20% (10.5% vs.4.2%, P less than .001). There were no differences in major clinical events according to the degree of oversizing, and a higher oversizing did not translate into an increased risk of permanent pacemaker (18.4% vs18.3%, P = .976). In TAVR with the Evolut valve, a higher oversizing was associated with lower rates of moderate-to-severe PVL and a lower need for post-dilation, with no negative impact on procedural and early clinical outcomes. A 20% oversizing threshold could be suggested to reduce PVLs. Further prospective studies are warranted to validate optimal oversizing for this valve system.

IntroductionTranscatheter aortic valve replacement (TAVR) is the first-line treatment for patients with moderate-to-high surgical risk of severe aortic stenosis. Paravalvular leakage (PVL) is a serious complication of TAVR, and aortic valve calcification contributes to the occurrence of PVL. This study aimed to investigate the effect of location and quantity of calcification in the aortic valve complex (AVC) and left ventricular outflow tract (LVOT) on PVL after TAVR.MethodWe performed a systematic review and meta-analysis to evaluate the effect of quantity and location of aortic valve calcification on PVL after TAVR using observational studies from PubMed and EMBASE databases from inception to February 16, 2022.ResultsTwenty-four observational studies with 6,846 patients were included in the analysis. A high quantity of calcium was observed in 29.6% of the patients; they showed a higher risk of significant PVL. There was heterogeneity between studies (I2 = 15%). In the subgroup analysis, PVL after TAVR was associated with the quantity of aortic valve calcification, especially those located in the LVOT, valve leaflets, and the device landing zone. A high quantity of calcium was associated with PVL, regardless of expandable types or MDCT thresholds used. However, for valves with sealing skirt, the amount of calcium has no significant effect on the incidence of PVL.ConclusionOur study elucidated the effect of aortic valve calcification on PVL and showed that the quantity and location of aortic valve calcification can help predict PVL. Furthermore, our results provide a reference for the selection of MDCT thresholds before TAVR. We also showed that balloon-expandable valves may not be effective in patients with high calcification, and valves with sealing skirts instead of those without sealing skirts should be applied more to prevent PVL from happening.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=354630, identifier: CRD42022354630.

Different Clinical Outcome of Paravalvular Leakage After Aortic or Mitral Valve Replacement

The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses. © 2016 Wiley Periodicals, Inc.

Transcatheter aortic valve replacement (TAVR) has become the standard treatment of multimorbid patients with severe aortic valve stenosis. One frequently observed complication after TAVR procedure is the occurence of paravalvular leakage (PVL). PVL is caused by a gap between the vessel wall and the TAVR stent, enabling blood to flow from the aorta back to the ventricle during diastolic phase. A high PVL rate leads to increased mortality of TAVR patients. To avoid this complication, pericardial skirts were developed by manufacturers to seal the leakage gap. Furthermore, the aim is to improve the conforming expansion of the TAVR stent to the vessel wall, especially for the self-expanding TAVR consisting of nitinol. One factor for the expansion is the size and shape of the TAVR stent cells, which vary between 9 and 15 cells in the circumferential direction for established TAVR devices. To quantify the impact of different cell sizes on the occurence of PVL, we performed numerical studies with different TAVR designs and investigated the PVL for each TAVR design. For this purpose, we developed three different TAVR designs with 9, 12 and 15 stent cells in the circumferential direction of the TAVR. These were deployed into a generic aortic root model with standardized calcification in the annulus region using finite element simulations. Afterwards, the PVL was calculated using numerical flow simulations. We found that the TAVR stent design with nine cells had the highest PVL rate (11.2mLs−1). In contrast, the TAVR stent design with 15 cells had the lowest PVL (4.8mLs−1). Our study thus showed a decisive impact of cell size on the sealing behavior of the TAVR stent and, accordingly, the PVL.

Incidence, Clinical Implications, and Predictors of Paravalvular Leak Following Transcatheter Tricuspid Valve Replacement: The TRIPLACE Registry.

Potential role of closure time with adenosine diphosphate in the diagnosis of mitral prosthetic paravalvular leak and prognosis after repair.

Paravalvular leakage (PVL) is one of the complications of transcatheter aortic valve implantation (TAVI), and its occurrence has been reported to affect long-term prognosis. We investigated whether the aortic valve calcification measured on preoperative CT is useful in predicting PVL after TAVI using the fifth-generation self-expanding valves. We analyzed 88 consecutive patients who underwent TAVI with the fifth-generation self-expanding valve from March 2023 to March 2024. Significant PVL was defined as PVL of mild or greater based on postoperative echocardiography results. We performed logistic regression analysis to evaluate whether patient background, and aortic valve calcification volume (AVCa-Vol), maximum CT value (AVCa-Max), mean CT value (AVCa-Ave), Agatston score (AV-Aga) and left ventricular outflow tract (LVOT) calcification volume measured by ECG-gated non-contrast CT were significant predictors. Mild or greater PVL was observed in 26 patients (29.5%). AVCa-Vol (1948.9mm3 vs 1427.9mm3, P < 0.01), AV-Aga (2412.8 vs 1743.7, P < 0.01), and LVOT calcification volume (109.8 vs 28.6, P < 0.01) were significantly higher in the PVL group. Univariate logistic regression analysis identified AVCa-Vol and AV-Aga as significant predictors, and they remained independent predictors after adjustment for age and sex (AVCa-Vol: odds ratio (OR) 2.91 (95% Confidence Interval (CI) 1.36-6.20), P < 0.01, AV-Aga: OR 2.24 (95% CI 1.25-4.03), P < 0.01). Receiver operating characteristic analysis showed optimal cutoff values for AVCa-Vol at 1665.13 mm3 (Area under the curve (AUC) = 0.73) and AV-Aga at 1908.59 (AUC = 0.72). AVCa-Vol and AV-Aga were identified as significant predictors of PVL occurrence after TAVI using the fifth-generation self-expandable valve.

Paravalvular leaks (PVLs) after transcatheter aortic valve replacement have a significant prognostic impact, and valve oversizing, particularly with self-expanding valves, may prevent postprocedural PVL occurrence. Recent iterations of the Evolut valve system are intended to reduce PVL, but the effects of oversizing with such valves on PVL are largely unknown. We aimed to assess, in a real-world contemporary setting, the impact of Evolut valve oversizing on PVL after transcatheter aortic valve replacement. This was a multicenter observational ambispective study of patients undergoing transcatheter aortic valve replacement with the Evolut PRO/PRO+/FX valves. Aortic annulus perimeter, as determined by multidetector computed tomography, was used to estimate the oversizing degree. The primary end point was the presence of PVL (mild/moderate-severe), as determined by echocardiography at hospital discharge. Secondary end points included in-hospital outcomes as defined by the Valve Academic Research Consortium-3 recommendations. A total of 762 patients were included (Evolut PRO/PRO+/FX, 55.5%/34.8%/9.7%), and the median valve oversizing was 20 (17-25)%, with no differences in baseline characteristics between low (≤20%, n=381) and high (>20%, n=381) valve oversizing recipients. In-hospital mortality and stroke rates were 2.4% and 4.3%, respectively, with no oversizing-related differences in clinical outcomes. Permanent pacemaker rates were similar in patients with low (19.4%) and high (15.8%) valve oversizing, P=0.21. PVL was found in 35.6% of patients (mild: 32.6%, moderate-severe: 3.0%), with a higher incidence of PVL in patients with low (40.9%) versus high (30.2%) oversizing, P=0.002. In a multivariable analysis, a higher oversizing degree was associated with a lower risk of PVL (odds ratio, 0.95 [0.92-0.99] for each 1% increase in oversizing, P=0.006). In transcatheter aortic valve replacement with recent Evolut valve iterations (PRO/PRO+/FX), a higher oversizing degree was associated with a lower frequency of PVL without increasing the risk of other complications (including permanent pacemaker). These data suggest that a low degree of valve oversizing should probably be avoided when using Evolut valves, particularly in borderline cases.

Background Despite extensive pre-procedure evaluation, greater than mild paravalvular leak (PVL) occurs in over 10% of patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with worse outcomes. Echocardiography, the standard method of imaging PVL, often has limited utility due to frequently multiple eccentric regurgitant jets. Acoustic shadowing from the valve stent and native aortic valve calcification may lead to further underestimation of PVL. Cardiovascular magnetic resonance (CMR) is considered the gold standard for quantification of valvular regurgitation. We evaluated the utility of CMR to grade PVL severity and predict outcomes in patients with suboptimal echocardiography. Methods Seventeen non-operative post-TAVR patients (NYHA class III-IV; age 84 ± 5 yrs) underwent CMR due to PVL and symptoms out of proportion to echocardiographic findings or suboptimal echocardiographic study. CMR was performed on a Siemens Avanto 1.5 T with velocity phase imaging in the ascending aorta for flow quantification. CMR PVL severity was graded by regurgitant fraction (RF; mild≤20%, moderate 21-39%, severe ≥40%). Short- and intermediate-term follow-up was conducted after CMR. Patients were followed-up for symptoms and a composite outcome of repeat invasive therapy, heart failure hospitalization, or death.

Paravalvular leak (PVL) occurs in 5% to 17% of patients following surgical valve replacement. Percutaneous device closure represents an alternative to repeat surgery. All UK and Ireland centers undertaking percutaneous PVL closure submitted data to the UK PVL Registry. Data were analyzed for association with death and major adverse cardiovascular events (MACE) at follow-up. Three hundred eight PVL closure procedures were attempted in 259 patients in 20 centers (2004-2015). Patient age was 67±13 years; 28% were female. The main indications for closure were heart failure (80%) and hemolysis (16%). Devices were successfully implanted in 91% of patients, via radial (7%), femoral arterial (52%), femoral venous (33%), and apical (7%) approaches. Nineteen percent of patients required repeat procedures. The target valve was mitral (44%), aortic (48%), both (2%), pulmonic (0.4%), or transcatheter aortic valve replacement (5%). Preprocedural leak was severe (61%), moderate (34%), or mild (5.7%) and was multiple in 37%. PVL improved postprocedure (P<0.001) and was none (33.3%), mild (41.4%), moderate (18.6%), or severe (6.7%) at last follow-up. Mean New York Heart Association class improved from 2.7±0.8 preprocedure to 1.6±0.8 (P<0.001) after a median follow-up of 110 (7-452) days. Hospital mortality was 2.9% (elective), 6.8% (in-hospital urgent), and 50% (emergency) (P<0.001). MACE during follow-up included death (16%), valve surgery (6%), late device embolization (0.4%), and new hemolysis requiring transfusion (1.6%). Mitral PVL was associated with higher MACE (hazard ratio [HR], 1.83; P=0.011). Factors independently associated with death were the degree of persisting leak (HR, 2.87; P=0.037), New York Heart Association class (HR, 2.00; P=0.015) at follow-up and baseline creatinine (HR, 8.19; P=0.001). The only factor independently associated with MACE was the degree of persisting leak at follow-up (HR, 3.01; P=0.002). Percutaneous closure of PVL is an effective procedure that improves PVL severity and symptoms. Severity of persisting leak at follow-up is independently associated with both MACE and death. Percutaneous closure should be considered as an alternative to repeat surgery.