Incidence Of Paravalvular Leak Research Articles

Impact of SAPIEN3 Ultra RESILIA on improvement of valve performance: Insights from the multicenter registry: a propensity-score matched analysis

Abstract Backgrounds: Transcatheter aortic valve implantation (TAVI) is now a cornerstone treatment for symptomatic severe aortic stenosis across all risk profiles, including low-risk and younger patients. As such, the performance and durability of transcatheter heart valves (THVs) are paramount. SAPIEN3 Ultra RESILIA (S3 UR) is expected to improve hemodynamics compared with SAPIEN3 (S3) due to the use of RESILIA bovine pericardial tissue and modified sawing maneuvers for each of three leaflets in 20 and 23mm valves. Aim The aim of study was to evaluate the hemodynamic improvement with S3 UR compared to S3 who underwent TAVI. Methods In a multicenter TAVI registry, we identified 1,931 patients who received a balloon-expandable valve over the past three years. We focused on post-procedural effective orifice area (EOA), post-procedural indexed EOA (EOAi), incidence of prosthesis-patient mismatch (PPM), paravalvular leakage (PVL) and post-procedural mean pressure gradient (mean PG) as our primary endpoints. We preformed propensity score matching analysis using a 1:1 ratio. Parameters including aortic stenosis severity, % oversizing and post dilatation were incorporated into the matching model. Results Of patients, mean age was 84 years old and 37.9% were male. EOAi was significantly larger in S3 UR group than in the S3 group for both cohorts [overall cohort: 1.21 (1.02 – 1.36) vs. 1.08 (0.93 – 1.26), P = 0.001; propensity matched cohort: 1.21 (1.01 – 1.35) vs. 1.11 (0.91 – 1.27), p = 0.042, respectively] (Figure 1). Similarly, the degree of PVL was significantly less in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, mild PVL was identified in 6.5% vs. 14.7%, and moderate PVL was present in 0.0% vs. 1.6% (p = 0.028). Peak PG and mean PG were significantly lower in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, peak PG was 17.7 (14.3 – 24.5) vs. 23.2 (18.2 – 29.2) (p = 0.001) and mean PG was 9.0 (7.1 – 12.5) vs. 11.5 (8.9 -14.8) (p = 0.005), respectively. The incidence of PVL ≥ mild, mean PG ≥ 20 mmHg, moderate PPM and severe PPM were tend to be lower in S3 UR group than in the S3 group for both cohorts (Figure 2). Conclusion The S3 UR valve exhibits significant hemodynamic improvements compared to the S3 valve, underscoring its potential for improved clinical outcomes in TAVI patients.

The Clinical Impact of Paravalvular Leaks With Transcutaneous Aortic Valve Implantation (TAVI) Versus Surgical Aortic Valve Replacement (SAVR): A Systematic Review and Meta-Analysis

Aortic valve stenosis is a common cardiac condition that requires intervention for symptomatic and/or prognostic reasons. The two most common interventions are surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). The ratio of TAVI:SAVR has increased twofold over the past few years and is now being considered in intermediate-risk patients as well. One of the significant benefits of TAVI is that it is less invasive; however, one of the drawbacks is a high paravalvular leaks (PVLs) rate compared to SAVR. To assess the impact of PVLs on survival, progression of heart failure, and the need for re-intervention. We conducted a comprehensive systematic literature search from the conception of TAVI 2002 until December 2022 through Embase (Ovid), MEDLINE (Ovid), Science Direct, and CENTRAL (Wiley). We followed PRISMA guidelines and checklists. Review protocol registration ID in PROSPERO: CRD42023393742. We identified 28 studies that met our eligibility criteria, and only 24 studies were suitable for pooling in a meta-analysis (including their hazard ratio with a confidence interval of 95%) assessing our primary outcome (all-cause mortality). The remaining four studies were narratively synthesised. RevMan V5.4 (Version 5.4. Cochrane Collaboration, 2020) was utilised to pool meta-analysis data to assess effect estimates of PVLs in both intervention arms, using a random effect model for calculation (hazard ratio 1.14 confidence interval 95% 1.08-1.21 [p<0.0001]), with a follow-up duration between 30 days to 5 years. Patients with mild or higher degrees of PVLs in both intervention arms incurred unfavourable outcomes. The incidence of PVLs was significantly higher with TAVI; even a mild degree led to poor quality of life and increased all-cause mortality on long-term follow-up.

Long-Term Assessment of Survival After Transcatheter Aortic Valve Implantation - Insights From the International Transcatheter Aortic Valve Implantation Registry.

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS), but despite estimates of life expectancy after TAVI being essential in heart team discussion, these data are scarce. Therefore, the current study sought to assess long-term survival and its trends in relation to chronological age, surgical risk, and treatment period.Methods and Results: We included 2,414 consecutive patients who underwent TAVI for severe symptomatic AS between 2008 and 2021 at 2 international centers. For the analysis, long-term survival was evaluated according to age, surgical risk, and treatment period categorized into 3 groups, respectively. The longest follow-up was 13.5 years. Overall survival was 67.6% at 5 years and 26.9% at 10 years. Younger patients, lower surgical risk, and later treatment period showed better survival (log-rank P<0.001, respectively). In the multivariate analysis, age <75years, lower surgical risk, and later time period were significantly associated with better survival. The incidence of paravalvular leakage ≥moderate, red blood cell transfusion, and acute kidney injury were independently associated with increasing risk of 5-year death. In a real-world registry, survival was substantial following TAVI, especially in younger and lower surgical-risk patients, with improving outcomes over time. This should be considered in heart team discussions of life-long management for AS patients after TAVI.

Mitral Kapak Replasmanında Sütür Tekniklerinin Karşılaştırmalı Değerlendirilmesi: Klinik Sonuçlar Üzerindeki Etkisi

Background: This study aimed to compare the outcomes of mitral valve replacement (MVR) using the intermittent simple suture technique versus the horizontal matrix suture technique with pledgeted in terms of paravalvular leakage and infective endocarditis. Methods: A retrospective analysis was conducted on 422 patients who underwent MVR between 2019 and 2023. Patients were divided into two groups based on the suture technique used: group B (simple suture technique) and group P (horizontal matrix suture technique with pledgeted). Propensity score matching was performed to balance the groups, resulting in 62 case pairs for comparative analysis. Results: There were no intraoperative mortalities, and the duration of cardiopulmonary bypass and cross-clamp time did not significantly differ between the two groups. No significant differences were observed in terms of total hospitalization time, early mortality, cerebrovascular events, and arrhythmias. Postoperative echocardiography revealed minimal paravalvular leakage in both groups, with non-serious leakage observed in 4 patients in group B and 2 patients in group P. The incidence of infective endocarditis was 1 in group B and 2 in group P. Hemolysis indicators showed higher mean values in the simple suture technique group, although not statistically significant. Conclusions: The study findings suggest that there is no significant difference in the incidence of paravalvular leak and infective endocarditis between the intermittent simple suture technique and the horizontal matrix suture technique with pledgeted. Both techniques can be safely employed in MVR.

Transcatheter Aortic Valve Implantation in Mixed Aortic Valve Disease: A Multicenter Study

Mixed aortic valve disease (MAVD), defined by the concurrent presence of aortic stenosis (AS) and insufficiency is frequently seen in patients who have undergone transcatheter aortic valve implantation (TAVI). However, studies comparing the outcomes of TAVI in MAVD versus isolated AS have demonstrated conflicting results. Therefore, we aim to assess the outcomes of TAVI in patients with MAVD in comparison with those with isolated severe AS. Patients who underwent native valve TAVI for severe AS at 3 tertiary care academic centers between January 2012 and December 2020 were included and categorized into 3 groups based on concomitant aortic insufficiency (AI) as follows: group 1, no AI; group 2, mild AI; and group 3, moderate to severe AI. Outcomes of interest included all-cause mortality and all-cause readmission rates at 30days and 1year. Other outcomes include bleeding, stroke, vascular complications, and the incidence of paravalvular leak at 30days after the procedure. Of the 1,588 patients who underwent TAVI during the study period, 775 patients (49%) had isolated AS, 606 (38%) had mild AI, and 207 (13%) had moderate to severe AI. Society of Thoracic Surgeons risk scores were significantly different among the 3 groups (5% in group 1, 5.5% in group 2, and 6% in group 3, p=0.003). Balloon-expandable valves were used in about 2/3 of the population. No statistically significant differences in 30-day or 1-year all-cause mortality and all-cause readmission rates were noted among the 3 groups. Post-TAVI paravalvular leak at follow-up was significantly lower in group 1 (2.3%) and group 2 (2%) compared with group 3 (5.6%) (p=0.01). In summary, TAVI in MAVD is associated with comparable outcomes at 1 year compared with patients with isolated severe AS.

Clinical Equivalence of Trubond® and Ethibond® Braided Polyester Sutures for Valvular Prosthesis Fixation During Aortic or Mitral Valve Replacement: A Single-Blind Randomized Controlled Trial.

Background Paravalvular leak (PVL) following valve replacement is a serious cardiovascular complication that increases morbidity and mortality. Valve replacement with the interrupted suture technique using polyester suture provides adequate tensile strength and reduces the probability of tissue reaction. This study compared the clinical equivalence of Trubond®(Healthium) and Ethibond® (Ethicon, Johnson & Johnson) braided polyester sutures for valvular prosthesis fixation using interrupted suturing, with respect to the proportion of subjects having PVL after aortic valve (AV) or mitral valve (MV) replacement. Methodology Patients undergoing AV/MV replacement were enrolled and randomized in this study. The primary endpoint of this prospective, multicentric, two-arm, randomized (1:1), parallel-group, single-blind study (December 2020-October 2022) was the presence of PVL in Trubond® (n = 40) and Ethibond® (n = 42) groups within 26 weeks of surgery. The secondary endpoints included event rate of all-cause mortality, cardiac death, stroke, myocardial infarction, re-hospitalization, re-intervention, wound infection, operative time, intraoperative suture parameters, postoperative hospital stay, time to resume normal activities and work, quality of life, patient satisfaction, and adverse events in both groups. Results Patients who underwent AV/MV replacement and were followed up until 26 weeks had no incidence of PVL or other postoperative complications. No requirement for readmission or re-intervention was noted in both groups. Intraoperative suture handling characteristics, operative time, and hospital stay were also comparable between the groups. With each follow-up, subjects in both groups exhibited improved postoperative functional abilities, quality of life, and health status. Conclusions Trubond® braided polyester suture is clinically equivalent to Ethibond® braided polyester suture. Trubond® suture is safe and effective for valvular prosthesis fixation in patients undergoing AV or MV replacement.

Quantity and location of aortic valve calcification predicts paravalvular leakage after transcatheter aortic valve replacement: a systematic review and meta-analysis.

Transcatheter 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. We 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. Twenty-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. Our 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. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=354630, identifier: CRD42022354630.

Early and Long-Term Clinical and Echocardiographic Outcomes of Sutureless vs. Sutured Bioprosthesis for Aortic Valve Replacement

Objective: The goal of this manuscript is to compare clinical and echocardiographic outcomes of patients undergoing aortic valve replacement (AVR) with Perceval sutureless bioprosthesis (SU-AVR) and sutured bioprosthesis (SB). Methods: Following the PRISMA statement, data were extracted from studies published after August 2022 and found in PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, ClinicalTrials.gov, SciELO, LILACS, and Google Scholar. The primary outcome of interest was post-procedural permanent pacemaker implantation, and the secondary outcomes were new left bundle branch block (LBBB), moderate/severe paravalvular leak (PVL), valve dislocation (pop-out), need for a second transcatheter heart valve, 30-day mortality, stroke, and echocardiographic outcomes. Results: Twenty-one studies were included in the analysis. When SU-AVR was compared to other SB, mortality ranged from 0 to 6.4% for Perceval and 0 to 5.9% for SB. Incidence of PVL (Perceval 1-19.4% vs. SB 0-1%), PPI (Perceval 2-10.7% vs. SB 1.8-8.5%), and MI (Perceval 0-7.8% vs. SB 0-4.3%) were comparable. In addition, the stroke rate was lower in the SU-AVR group when compared to SB (Perceval 0-3.7% vs. SB 1.8-7.3%). In patients with a bicuspid aortic valve, the mortality rate was 0-4% and PVL incidence was 0-2.3%. Long-term survival ranged between 96.7 and 98.6%. Valve cost analysis was lower for the Perceval valve and higher for sutured bioprosthesis. Conclusions: Compared to SB valves, Perceval bioprosthesis has proved to be a reliable prosthesis for surgical aortic valve replacement due to its non-inferior hemodynamics, implantation speed, reduced cardiopulmonary bypass time, reduced aortic cross-clamp time, and shorter length of stay.

Rapid-Deployment Aortic Valve Replacement: Patient Selection and Special Considerations.

Sutureless or rapid deployment valves in the setting of aortic valve replacement (AVR) is an emerging surgical technique using the transcatheter valve technology, which may lead to reduction in cross-clamp time and potentially better hemodynamics compared to a stented bioprosthetic valve. The absence of subannular pledgets results to excellent hemodynamic performance with reduced turbulent flow and larger effective orifice area. However, complications from both surgical and transcatheter AVR may still occur and impact survival. The incidence of paravalvular leakage and permanent pacemaker implantation are not low. Although technical modifications can improve these outcomes, there is a learning curve effect. Therefore, technical and anatomical considerations as well as better patient selection are paramount for better outcomes. In this review, we discuss the use of sutureless or rapid deployment valves in setting of (1) complex procedures, (2) minimally invasive AVR, and (3) small aortic annulus. The advantage of sutureless or rapid deployment valves in terms of mortality remains to be clarified; therefore, it is necessary to accumulate long-term outcomes in an appropriate patient cohort.

Transthoracic echocardiographic assessment of cardiac valves in patients with Behçet's disease.

The main objectives of the current study are to investigate valvular involvement in patients with cardiac Behçet's disease (BD) and find out the risk factors of valvular involvement in cardiac BD. We retrospectively assessed the clinical and echocardiographic data in the medical records of 121 patients with BD admitted to Beijing Anzhen Hospital from January 2015 to January 2022. We evaluated the valvular structure and function mainly by echocardiography. A total of 77 BD patients (77/121, 63.64%) had cardiac valvular involvement. Valvular lesions occurred more frequently in males (p = 0.022). Aortic regurgitation (AR) (62/77, 80.52%) was the most common finding and severe AR occupied 80.65% (50/62). The most common manifestations of BD patients with severe AR was aortic valve prolapse (25/50, 50%), followed by echo-free spaces within the aortic annulus (11/50, 22%), vegetation-like lesions (10/50, 20%), and aortic root aneurysm (10/50, 20%). The incidence of paravalvular leaks (PVL) in BD patients was 14.29% (7/49). The diameter of the sinus of Valsalva and proximal ascending aorta, and total cholesterol (TCHO) were the independent risk factors of moderate-severe aortic valvular regurgitation (p < 0.01). Left ventricular end-diastolic dimension (LVEDD), left ventricular ejection fraction (LVEF) and brain natriuretic peptide (BNP) were significantly associated with moderate-severe mitral valvular regurgitation (p < 0.01). The most common valvular abnormality in BD is AR. Echocardiography has great value in the comprehensive evaluation and accurate diagnosis of valvular involvement in BD patients.

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve:A rapid deployment bioprosthesis. A systematic review of the literature.

To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement(TAVR). The incidence of paravalvular leak(PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation(Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction(MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%. This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.

30-Day Outcomes after Surgical or Transapical Aortic Valve Replacement in Symptomatic Aortic Regurgitation.

Background: We aimed to analyze the short-term clinical outcomes of transapical aortic valve replacement (TA-TAVR) compared with surgical aortic valve replacement (SAVR) in symptomatic aortic regurgitation (AR) patients to draw preliminary conclusions about the advantages and disadvantages of TA-TAVR compared with SAVR and to provide evidence for future use of TA-TAVR in AR patients. Method: From September 2016 to September 2021, 69 patients undergoing TA-TAVR with J-valve implantation and 42 patients undergoing SAVR at the Second Hospital of Zhejiang University School of Medicine were analyzed for clinical data and 30-day follow-up outcomes to analyze and compare the differences in clinical endpoints between the two procedures. Results: At 30-day follow-up, there were no significant differences in mortality or neurological events between the two groups before and after the PSM. In secondary endpoints there were significant differences between the pre-match TAVR and SAVR groups, such as the incidence of paravalvular leaks (33.8% vs. 4.8%, p < 0.05), which also remained after the PSM (37.5% vs. 0, p < 0.05). In addition, the incidence of major bleeding was 7.4% in the TAVR group and 26.2% in the SAVR group before matching (p < 0.05). After matching, the statistical difference still remained. In longitudinal comparison, significant improvements in postoperative cardiac ultrasound indices and NYHA classification occurred in both groups. Conclusion: The TA-TAVR approach is safe and reliable, with similar clinical efficacy to SAVR, and has advantages in bleeding rate and speed of recovery.

Biomechanics of Transcatheter Aortic Valve Implant.

Transcatheter aortic valve implantation (TAVI) has grown exponentially within the cardiology and cardiac surgical spheres. It has now become a routine approach for treating aortic stenosis. Several concerns have been raised about TAVI in comparison to conventional surgical aortic valve replacement (SAVR). The primary concerns regard the longevity of the valves. Several factors have been identified which may predict poor outcomes following TAVI. To this end, the lesser-used finite element analysis (FEA) was used to quantify the properties of calcifications which affect TAVI valves. This method can also be used in conjunction with other integrated software to ascertain the functionality of these valves. Other imaging modalities such as multi-detector row computed tomography (MDCT) are now widely available, which can accurately size aortic valve annuli. This may help reduce the incidence of paravalvular leaks and regurgitation which may necessitate further intervention. Structural valve degeneration (SVD) remains a key factor, with varying results from current studies. The true incidence of SVD in TAVI compared to SAVR remains unclear due to the lack of long-term data. It is now widely accepted that both are part of the armamentarium and are not mutually exclusive. Decision making in terms of appropriate interventions should be undertaken via shared decision making involving heart teams.

Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis.

Objective: To highlight the main target points covered by clinical studies on the Perceval sutureless valve for surgical aortic valve replacement (SAVR) and raise a point of discussion for further expansion of its use when compared with stented bioprostheses (SB) and transcatheter aortic valve replacement (TAVR).Methods: We reviewed clinical trials and retrospective studies published up to date and compared the outcomes in terms of mortality, myocardial infarction (MI) stroke, paravalvular leak (PVL), permanent pacemaker implantation (PPI), bleeding and long-term outcomes.Results: Clinical studies showed that 30-day mortality ranged from 0–4% for Perceval and 2.9–7% for TAVR. The incidence of PVL (Perceval 1.9–19.4 vs. TAVR 9–53.5%), PPI (Perceval 2–11.2 vs. TAVR 4.9–25.5%), stroke (Perceval 0 vs. TAVR 0–2.8%), MI (Perceval 0 vs. TAVR 0–3.5%), were all higher in the TAVR group. Compared to other SB, mortality ranged from 0–6.4% for Perceval and 0–5.9% for SB. The incidence of PVR (Perceval 1–19.4 vs. SB 0–1%), PPI (Perceval 2–10.7 vs. SB 1.8–8.5%), stroke (Perceval 0–3.7 vs. SB 1.8–7.3%) and MI (Perceval 0–7.8 vs. SB 0–4.3%) were comparable among the groups. In patients with a bicuspid aortic valve, mortality rate was (0–4%) and PVL incidence was (0–2.3%). However, there was a high incidence of PPI (0–20%), and stroke (0–8%). Long-term survival ranged between 96.7–98.6%.Conclusions: The Perceval bioprosthesis has proved to be a reliable prosthesis for surgical aortic valve replacement due to its implantation speed, the reduced cardiopulmonary bypass time, the reduced aortic cross-clamp time and the shorter intensive care unit and hospital length of stay.

Transcatheter Aortic Valve Replacement in Patients With a Small Annulus - From the Japanese Nationwide Registry (J-TVT).

The details and consequences of a small aortic annulus among transcatheter aortic valve replacement (TAVR) patients remain uncertain. This study investigated the short-term outcomes in patients with small annular size and compared the 30-day outcome between intra- and supra-annular devices, with similar outer casing diameter in this subgroup. Cases registered in the Japanese national TAVR registry between August 2013 and December 2017 were analyzed. Among a total of 5,870 registered patients, 647 (11.0%) had small annulus (area ≤314 mm2) measured by multi-detector computed tomography. Patients with a small annulus had a significantly smaller indexed effective orifice area (iEOA, 1.10 cm2/m2[0.92-1.35] vs. 1.16 cm2/m2[0.96-1.39], P<0.001) and higher mean pressure gradient (mPG, 10.0 mmHg [6.9-14.2] vs. 8.5 mmHg [6.0-11.5], P<0.001) compared with a normal-sized annulus. Among patients with a small annulus, those receiving a 20 mm intra-annular device had a smaller iEOA (0.94 cm2/m2[0.78-1.06] vs. 1.07 cm2/m2[0.8-1.24], P=0.001) and higher mPG (14.0 mmHg [10.0-18.5] vs. 11.0 [7.0-14.0], P<0.001) compared with those receiving a 23-mm supra-annular device, although the incidence of paravalvular leakage (≥moderate) was similar (14.4% vs. 16.5%, P=0.69). Patients with a small annulus were associated with less hemodynamic improvement. A supra-annular device is associated with better echocardiographic improvement in patients with a small annulus, without increasing paravalvular leakage.

Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis.

BackgroundThis meta-analysis was conducted to compare the procedural and early outcomes of aortic valve replacement (AVR) using rapid deployment valve (RD group) versus sutureless valve (SU group).MethodsA literature search of 5 online databases was conducted. The primary outcomes were mean transvalvular pressure gradient (MPG) after AVR, the incidence of paravalvular leak (PVL) and the need for a permanent pacemaker implantation (PPI). The secondary outcomes included aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) times, early mortality and other postoperative complications, such as atrial fibrillation, bleeding reoperation and stroke.ResultsEight articles were included, and all outcomes except MPG after AVR in matched valve sizes were extracted from 7 studies (RD group =842 patients and SU group =1,386 patients). The pooled analysis demonstrated a lower MPG in the RD group than in the SU group, with mean difference (MD) of 2.64 mmHg. The pooled risk ratios of any PVL and grade ≥2 (or moderate) PVL were not significantly different between the groups; however, the incidence of PPI was significantly lower in the RD group than in the SU group, with a risk ratio of 0.69. The pooled analyses showed that the ACC and CPB times were significantly longer in the RD group than in the SU group, with weighted MDs of 8.74 (P<0.001) and 9.94 (P<0.001) minutes, respectively. The risks of early mortality and other postoperative complications were not significantly different between the groups.ConclusionsAVR using RD valve was associated with better valve hemodynamics in terms of the MPG than AVR using SU valve, and better outcomes were observed in the RD group regarding PPI. Procedural times were longer in AVR using RD valve than SU valve. Early clinical outcomes showed no difference between RD and SU valve.

Feasibility and safety of oversizing self-expandable valves for transcatheter aortic valve implantation, according to aortic annulus maximal diameter

Abstract Background Transcatheter aortic valve implantation (TAVI) can lead to paravalvular leak (PVL) in 15% to 20% of cases, which remains an important prognostic factor and an independent predictor of mortality in short and long-term follow-up. Objectives To evaluate feasibility and safety of oversizing Medtronic Self-Expandable Valve (Dvalve), calculated according to the aortic annulus maximal diameter (Dmax), on the incidence of PVL and in-hospital mortality after TAVI. Methods We retrospectively analyzed the data of 610 patients treated with TAVI between January 2016 and December 2018. A group of 45 patients of the oversized group (October 2017 to December 2018) accordingly to the Dmax, when (Dvalve − Dmax) | &amp;lt;2 mm in the absence of contraindication was compared to a control group of 213 patients whose prosthesis size had been chosen according to the aortic annulus perimeter (January 2016 to September 2017). Results In the “oversized” group, no patient had a significant PVL after TAVI compared with the control group (0% vs. 7.51%; p=0.041). Balloon post-dilatation was significantly less frequent in the “oversized” group (0% vs. 10.3%; p=0.012). Per-procedural irradiation and the average length of in-hospital stay were significantly lower (PDS = 2,296.05±1,667.94 cGy·mm2 vs. 4,568±1,352.84 cGy·mm2; p&amp;lt;0.001; and 5.23±1.74 days vs. 6.33±3.23 days; p=0.029, respectively). No case of annulus rupture occurred in the “oversized” group. The incidences of high-degree atrioventricular block with definitive pacing and in-hospital mortality were similar between the two groups. Conclusion Oversizing the self-expandable valve, according to the aortic annulus maximal diameter, significantly reduced PVL after TAVI, balloon post-dilatation, per-procedural irradiation, and the length of hospital stay, without increasing the risk of mechanical, rhythmic, conductive and coronary occlusion complications. It does not increase the in-hospital mortality rate either. Randomized controlled trials are needed to establish a firm conclusion about its feasibility and safety. Funding Acknowledgement Type of funding source: None

Paravalvular Leak Assessment: Challenges in Assessing Severity and Interventional Approaches.

With increasing use of prosthetic valves to treat degenerative valvular heart disease (VHD) in an aging population, the incidence and adverse consequences of paravalvular leaks (PVL) are better recognized. The present work aims to provide a cohesive review of the available literature in order to better guide the evaluation and management of PVL. Despite gains in operator experience and design innovation, significant PVL remains a significant complication that may present with congestive heart failure and/or hemolytic anemia. To date, clear consensus or guidelines on the evaluation and management of PVL remain lacking. Although the evolution of transcatheter valve therapies has had a tremendous impact on the management of patients with VHD, the limitations and complications of such techniques, including PVL, present further challenges. Incidence of PVL, graded as moderate or greater, ranges from 4 to 7.4% in surgical and transcatheter valve replacements, respectively. Improved imaging modalities and the advent of novel surgical and percutaneous therapies have undoubtedly yielded a better understanding of PVL including its anatomical location, mechanism, severity, and treatment options. Echocardiography, used in conjunction with cardiac computed tomography and cardiac magnetic resonance, provides essential details for diagnosis and management of PVL. Transcatheter intervention has become a favored approach in lieu of surgical intervention in select patients after previous surgical or percutaneous valve replacement. PVL treatment with vascular plugs, balloon post-dilation, and the valve-in-valve methods have shown technical success with promising clinical outcomes in appropriately selected patients.

Effect of a fourth-generation transcatheter valve enhanced skirt on paravalvular leak.

The aim of this study was to assess the 30 day incidence of paravalvular leak (PVL) and need for aortic valve reintervention of a fourth generation balloon expandable transcatheter valve with enhanced skirt (4G-BEV) (SAPIEN 3 Ultra) compared with a third generation balloon expandable transcatheter valve (3G-BEV) (SAPIEN 3). The incidence of PVL has steadily declined with iterative improvements in transcatheter aortic valve replacement (TAVR) technology and implantation strategies. Patients who underwent TAVR at Mayo Clinic from 7/2018 to 7/2019 were included in a prospective institutional registry. 4G-BEV has been utilized since 2/2019, and, after this date, 3G-BEV and 4G-BEV were simultaneously used. 4G-BEV had three sizes (20, 23, and 26 mm) while 3G-BEV included four sizes (20, 23, 26, and 29 mm). Both cohorts were evaluated at 30 days post-TAVR with a transthoracic echocardiogram to assess for PVL. A total of 260 consecutive patients were included. Of these, 101 patients received a 4G-BEV and 159 patients received a 3G-BEV. There were more females (p = .0005) and a lower aortic valve calcium score (p = .02) in the 4G-BEV cohort at baseline. Age, STS risk score, NYHA Class, and aortic valve mean gradient did not differ between groups. 4G-BEV was associated with a lower incidence of mild PVL (10.8 vs. 36.5%; p < .0001) and moderate PVL (0 vs. 5.8%) compared to the 3G-BEV at 30 days. There was no association between PVL and valve size in either cohort. Utilization of 4G-BEV is associated with reduced PVL at 30 days post-TAVR compared with 3G-BEV.

Discussion

Discussion