Rate Of Paravalvular Leakage Research Articles

Conduction disorders after transcatheter aortic valve implantation: A comparison between SAPIEN 3 and SAPIEN 3 Ultra balloon-expandable valves.

Conduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve. We included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge. No significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer's guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001). No significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Small Annuli.

Background: Self-expanding transcatheter valves (THV) seem superior to balloon-expanding valves in regard to the incidence of prosthesis–patient mismatch (PPM). Data on the occurrence of PPM with the ACURATE neo/neo2 system as a representative of self-expanding prostheses in very small annuli, even below the applicable instructions for use (IFU), are scarce. Methods: Data from 654 patients with severe native aortic stenosis treated with the smallest size ACURATE neo/neo2 valve (size S, 23 mm) at two German high-volume centers from 06/2012 to 12/2021 were evaluated. We compared clinical and hemodynamic outcomes among patients with implantation in adherence to the recommended sizing (on-label n = 529) and below the recommended sizing range (off-label n = 125) and identified predictors for PPM in the overall population. BMI-adjusted PPM was defined according to VARC-3 recommendations. Results: Post-procedure, the mean gradient (10.0 mmHg vs. 9.0 mmHg, p = 0.834) and the rate of paravalvular leakage (PVL) ≥ moderate (3.2% vs. 2.8%, p = 0.770) were similar between on-label and off-label implantations. The rate of moderate to severe PPM (24%) was comparably low in ACURATE neo/neo2 S, with a very low proportion of severe PPM whether implanted off- or on-label (4.9% vs. 3.8%, p = 0.552). Thirty-day all-cause mortality was higher among patients with off-label implantations (6.5% vs. 2.3%, p = 0.036). In the subgroup of these patients, no device-related deaths occurred, and cardiac causes did not differ (each 5). Besides small annulus area and high BMI, a multivariate analysis identified a greater cover index (OR 3.26), deep implantation (OR 2.25) and severe calcification (OR 2.07) as independent predictors of PPM. Conclusions: The ACURATE neo/neo2 S subgroup shows a convincing hemodynamic outcome according to low mean gradient even outside the previous IFUs without a relevant increase in the rate of PVL or PPM. In addition to known factors such as annulus area and BMI, potential predictors for PPM are severe annulus calcification and implantation depth. Nevertheless, the ACURATE neo/neo2 system seems to be a reliable option in patients with very small annuli.

TAVI for Pure Non-calcified Aortic Regurgitation Using a Self-Expandable Transcatheter Heart Valve.

Objectives: Transcatheter aortic valve implantation (TAVI) is routinely performed in patients with severe aortic stenosis (AS). For patients with pure non-calcified aortic regurgitation (AR) who are not suitable for open heart surgery no clear recommendations exist and use of TAVI has been largely off-label. We herein report a series of patients treated with the self-expandable AcurateNeo and Neo2 (Boston Scientific Co., Marlborough, MS, USA) transcatheter heart valve (THV) for pure AR.Methods: Between 05/2017 and 03/2021, 9 patients (88.8% female, 74.4 ± 7.1 years, logEuroSCORE II 5.5 ± 3.6%, STS PROM 6.2 ± 3.0%) received transfemoral (TF) TAVI for pure non-calcified AR following an adjusted valve sizing algorithm. Data were retrospectively analyzed according to updated Valve Academic Research Consortium (VARC-2) definitions.Results: Device success was 100%. Early safety was 77.7% (7/10), due to two (22.2%) cases of acute kidney injury. Thirty-day mortality was 0%, in seven (77.7%) patients no or trace paravalvular leakage (PVL) was seen and mild PVL in two (22.2%) patients at 30-day follow-up. No permanent pacemaker (PPM) was required during 30-day follow-up.Conclusion: In this series of selected patients using the Acurate neo THV for pure non-calcified AR, safety and efficacy were demonstrated. Thirty-day mortality as well as PPM implantation and PVL rates showed excellent results in this high-risk patient cohort. These results will have to be confirmed in larger patient cohorts.

Impact of diverse aortic pathologies on outcomes after transapical transcatheter aortic valve replacement.

Some patients who undergo transcatheter aortic valve replacement (TAVR) have a concomitant diverse aortic pathologies (AP). They are usually considered high-risk candidates for the procedure and require further assessment to determine the best vascular approach. The impact of these AP on TAVR is not well known as the information is scarce. We aimed to evaluate midterm clinical impact of different AP after transapical (TA)-TAVR. Twenty patients with atherosclerotic/occluding aortic diseases (A/OAD) (porcelain aorta, Leriche Syndrome, penetrating aortic ulcer, and aortic thrombus), 24 patients with aortic morphologic diseases (AMD) (thoracic/abdominal aortic aneurysms, aortic kinking, aortic type B dissection, aortic elongation/tortuosity, and previous aortic intervention), and 11 patients with combined aortic diseases (CAD) underwent TA-TAVR treatment between January 2011 and November 2019 at our center. We conducted up to 5-years clinical follow-up. All patients were classified in the heart team as a high interventional risk. The 30-day mortality and stroke were 5% and 10% in the A/OAD, 8.3% and 0% in the AMD, and 0% and 0% in the CAD, respectively. The median time of freedom from a composite of death and cardio-cerebral adverse events was 22.1 months [95% confidence interval [CI]: 9.9-34.3] in A/OAD versus 34.3 months [95% CI: 15.6-53] in AMD versus 17 months [95% CI: 0-39.4] in CAD; p = .525. We registered neither procedural aortic injury nor aortic syndrome at follow-up. The moderate/severe paravalvular leakage rates were 5%, 0% and 0% in the A/OAD, AMD and CAD, respectively. Independent of underlying AP, the TA-TAVR is a safe method and shows very promising early and midterm outcomes in patients with various AP.

Effectiveness and Safety of the ACURATE Neo Prosthesis in 1,000 Patients With Aortic Stenosis

The ACURATE neo transcatheter heart valve has demonstrated a balanced profile with low rates of permanent pacemaker implantation, low risk of coronary obstruction, and favorable hemodynamic properties whilst having an acceptable rate of ≥moderate paravalvular leakage (PVL). Here, we report in-hospital results and assess the learning curve for implantation of the ACURATE neo device in a large, single-center cohort. The cohort of this retrospective, observational study comprised 1,000 consecutive patients with severe aortic stenosis who underwent transfemoral transcatheter aortic valve implantation using the ACURATE neo prosthesis between May 2012 and December 2019. We determined procedural outcomes with emphasis on PVL and analyzed the learning curve. The median age was 81.9 years [IQR 78.8; 85.1], and the Euroscore II was 4.2% [IQR 2.7; 7.3]. The rate of PVL ≥moderate measured by echocardiography at discharge was 3.7% (37 of 988). We observed a learning curve, with a decline in ≥moderate PVL from 6.7% in the first quartile to 0.8% in the last quartile, that was related to better patient selection, more oversizing, and consideration of the amount and distribution of aortic valve calcification. In this thus far largest single-center experience using the ACURATE neo prosthesis, we demonstrate that after completing a learning curve and observation of precepts that include patient selection, careful sizing, and procedural aspects, the rate of ≥moderate PVL may be reduced to <1%.

The Prognostic Value of C-reactive Protein to Albumin Ratio in Patients with Isolated Degenerative Aortic Valve Stenosis Undergoing Surgical Aortic Valve Replacement.

ObjectiveTo evaluate the prognostic value of C-reactive protein to albumin ratio (CAR) in patients with severe aortic valve stenosis undergoing surgical aortic valve replacement (AVR).MethodsFour hundred seventy-six patients with severe degenerative aortic stenosis who underwent successful isolated surgical AVR were enrolled. Hospitalization due to heart failure, surgical aortic reoperation, paravalvular leakage rates, and long-term mortality were evaluated in the whole study group. The participants were divided into two groups, as 443 patients without mortality (group 1) and 33 patients with mortality (group 2) during the follow-up time.ResultsCAR was lower in patients without mortality than in those with mortality during the follow-up time (0.84 [0.03-23.43] vs. 2.50 [0.22-26.55], respectively, P<0.001). Age (odds ratio [OR]: 1.062, confidence interval [CI]: 1.012-1.114, P=0.014), CAR (OR: 1.221, CI: 1.125-1.325, P<0.001), ejection fraction (OR: 0.956, CI: 0.916-0.998, P=0.042), and valve type (OR: 2.634, CI: 1.045-6.638, P=0.040) were also found to be independent predictors of long-term mortality. Additionally, rehospitalization (0.86 [0.03-26.55] vs. 1.6 [0.17-24.05], P=0.006), aortic reoperation (0.87 [0.03-26.55] vs. 1.6 [0.20-23.43], P=0.016), and moderate to severe aortic paravalvular leakage (0.86 [0.03-26.55] vs. 1.86 [0.21-19.50], P=0.023) ratios were associated with higher CAR.ConclusionIt was firstly described that CAR was strongly related with increased mortality rates in patients with isolated severe aortic stenosis after surgical AVR. Additionally, rehospitalization, risk of paravalvular leakage, and aortic reoperation rates were higher in patients with increased CAR than in those without it.

Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part I: Paravalvular Leakage.

While transcatheter mitral valve (TMV) replacement technology has great clinical potential for surgically inoperable patients suffering from mitral regurgitation, no TMV has yet achieved regulatory approval. The diversity of devices currently under development reflects a lack of consensus regarding optimal design approaches. In Part I of this two-part study, a test system was developed for the quantification of paravalvular leakage (PVL) following deployment of a TMV or TMV-like device in pressurized, explanted porcine hearts (N=7). Using this system, PVL rate was investigated as a function of steady trans-mitral pressure (ΔP), TMV shape, and TMV-annular oversizing, using a series of "mock TMV plug" devices. Across all devices, PVL was found to approximately trend with the square of ΔP. PVL rates were approximately 0-15mL/s under hypotensive pressure, 10-40mL/s under normotension, and 30-85mL/s under severe hypertension. D-shaped devices significantly reduced PVL vs. circular devices; however, this effect was diminished upon oversizing to the annulus by 6mm inter-trigonal distance. In conclusion, this steady pressure, in vitro test system was effective to compare PVL performance across TMV-like designs. PVL exhibited complex dynamics in terms of its response to transvalvular pressure and TMV profile.

Comparative analysis of balloon- versus mechanically-expandable transcatheter heart valves considering landing zone calcification

BackgroundThe balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. MethodsThis retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access. Outcome was assessed according to VARC II definitions. Rate of paravalvular leakage (PVL), periprocedural stroke, and permanent pacemaker implantation (PPI) was adjusted for THV landing zone calcification as calculated by multi-slice computed tomography. ResultsThere was no difference in preoperative risk (all results as follows S3 vs. Lotus: STS-PROM 5.9±5.6% vs. 4.8±2.6%, p=0.14), rate of device success (95.3% vs. 95.1%, p=0.67), 30-day mortality (1.9% vs. 4.9%, p=0.16), periprocedural stroke (1.4% vs. 4.9%, p=0.27), and major access site complications (9.4% vs. 9.8%, p=0.93). PPI was more frequent (19.4% vs. 34.4%, p=0.01) and significant PVL was less frequent (≥mild PVL: 17.6% vs. 3.7%, p=0.04) after Lotus implantation. No association was found between landing zone calcification and periprocedural stroke rate (OR 1.19, 95%CI 0.92–1.54, p=0.17) or need for PPI (OR 1.04, 95%CI 0.91–1.18, p=0.57). The extent of landing zone calcification was associated with risk for PVL ≥mild (OR 1.21, 95%CI 1.03–1.42, p=0.02). After adjusting for landing zone calcification risk for PVL ≥mild was lower with the Lotus valve (OR 0.15, 95%CI 0.02–0.54, p=0.01). ConclusionBoth THVs yield comparable procedural and clinical outcomes except for a higher PPI rate with the Lotus valve, which is independent from the extent of landing zone calcification. The extent of landing zone calcification is associated with an increased risk for PVL for both THV, but is significantly reduced with the Lotus valve.

Paravalvular regurgitation after transcatheter aortic valve replacement: Diagnosis, clinical outcome, preventive and therapeutic strategies

Paravalvular regurgitation is a common, potentially life-threatening complication of transcatheter aortic valve replacement. Previous studies report a 65%-94% rate of paravalvular leakage after transcatheter implantation, mostly of mild degree. The rate of significant (≥ +2) paravalvular regurgitation varies in large clinical trials, and is associated with worse clinical outcome. There is less agreement regarding the significance of mild regurgitation (grade 1+). There are anatomical and procedural correlates for paravalvular leak-most importantly, severe valve calcification, patient prosthetic mismatch, and device malposition. The following review details the current knowledge on paravalvular regurgitation after transcatheter aortic valve replacement, including diagnosis, correlates, clinical outcome, preventive and therapeutic strategies related to this complication.

Transcatheter aortic valve implantation after previous coronary artery bypass grafting: a potential gold standard of care

Ducrocq et al. [1] present in their article the results of 201 patients undergoing transcatheter aortic valve implantation (TAVI). The group was divided into 54 patients with previous coronary artery bypass grafting (CABG) and 147 without. The perioperative and postoperative results were compared. The authors conclude that the TAVI procedure may be ‘an attractive option in the population of high-risk patients with aortic stenosis and previous CABG’. They should be congratulated for achieving these encouraging results. Nevertheless, their article suggests several questions. First, as shown by Tamburino et al., the rate of paravalvular leakage has an independent impact upon follow-up mortality [2]. Unfortunately, Ducrocq et al. do not present the rate of postoperative aortic insufficiency [1]. As known, the choice of valve implanted and the implantation technique will influence the rate of paravalvular leakage [3]. Ducrocq et al. state that, in the group with previous CABG, 43% received transapical valve implantation and had lower perioperative mortality, whereas in the group without previous CABG only 26% had transapical valve implantation [1]. Nevertheless, the transapical approach was an independent predictor of 2-year mortality, possibly resulting from negative selection. The choice of valve and implantation technique should not be guided only by the degree of peripheral vessel disease, but should be aimed at achieving more precise handling and positioning of the valve, resulting in a lower rate of paravalvular leakage and consequently improved early and late outcome [4, 5]. Additionally, patients with previous heart surgery often present with reduced left ventricular function. Although there was no significant difference between the groups presented by Ducrocq et al. [1], paravalvular insufficiency will influence their late mortality [2]. Secondly, in three patients, PCI on a graft was performed before the TAVI procedure as part of a staged procedure. Why does their team not perform the coronary or graft intervention during the TAVI procedure? To eliminate the risk of complications due to the pathological feature left untreated during the waiting time for the second procedure, the treatment of both pathologies simultaneously should be considered as an alternative [6]. As a matter of fact I believe that untreated coronary artery disease, in this particular cohort of patients that presents a complex co-morbidity profile, could negatively impact intraoperative and late mortality. As shown by Ducrocq et al. [1] 41% of the patients in the non-CABG group presented coronary artery disease, whereas only 15% were previously treated by PCI. Could this be interpreted as a sign of incomplete myocardial revascularization? As already emphasized, I believe not only that TAVI can be safely performed in patients with previous CABG, but also that TAVI combined with PCI should be performed to treat the most significant coronary lesion(s) that could put at jeopardy large myocardial areas [6]. As shown by Ducrocq et al. [1], TAVI is an attractive option in the population of high-risk patients with aortic stenosis and previous CABG. Future studies will show whether TAVI will become the ‘gold standard of care’ in all patients after previous heart surgery.