Incidence Of Paravalvular Regurgitation Research Articles

Hemodynamics and Conduction Disturbance After Transcatheter Aortic Valve Implantation With SAPIEN3 Ultra Versus SAPIEN3: The HomoSAPIEN 2 Study

The optimal percent oversizing (%OS) using the SAPIEN3 Ultra (S3U) weighing the incidence of paravalvular regurgitation (PVR) ≥ mild against the risk of conduction disturbance (CD) is not known. This study sought to define an optimal extent of the annulus area %OS suitable for transcatheter aortic valve implantation with the S3U compared with the SAPIEN3 (S3). A total of 350 patients with the S3U were compared with 606 patients with the S3. Patients were categorized depending on the degree of %OS. PVR ≥ mild was observed in 8.9% of patients with the S3U and in 21.8% of those with the S3 (p <0.001). The S3U demonstrated a sustainably lower incidence of PVR ≥ mild than the S3 in any extent of %OS. There was an inverse proportional relation between the extent of %OS and frequency of PVR ≥ mild in the S3, whereas the S3U group provided little change. The incidences of PVR ≥ mild were steady >5%OS in the S3 (5% to 10%OS: 13.3%, and >10%OS: 12.1%) and >0%OS in the S3U (0% to 5%OS: 5.9%, 5% to 10%OS: 6.0%, and >10%OS: 6.1%). An increasing %OS was independently associated with the occurrence of CD (<0%OS: 9.8%, 0% to 5%OS: 13.1%, 5% to 10%OS: 16.6%, and >10%OS: 19.2%, p=0.012). The incidence of PVR ≥ mild and/or CD was the lowest (10.1%) in the 0% to 5%OS in patients with the S3U. In conclusion, the HomoSAPIEN2 study suggests that the S3U tolerates a lesser degree of %OS for mitigating PVR ≥ mild than the S3. Minimal %OS, ranging from 0% to 5%, may be optimal for the S3U with balancing the risk of PVR and CD. Trial Identifier: UMIN000040413/URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046115.

Impact of Annular Oversizing on Paravalvular Regurgitation and ValveHemodynamics: New Insights From PARTNER 3.

This study sought to investigate the impact of computed tomography (CT)-based area and perimeter oversizing on the incidence of paravalvular regurgitation (PVR) and valve hemodynamics in patients treated with the SAPIEN 3 transcatheter heart valve (THV). The incremental value of considering annular perimeter or left ventricular outflow tract measurements and the impact of THV oversizing on valve hemodynamics are not well defined. The PARTNER 3 (Placement of Aortic Transcatheter Valves 3) trial included 495 low-surgical-risk patients with severe aortic stenosis who underwent THV implantation. THV sizing was based on annular area assessed by CT. Area- and perimeter-based oversizing was determined using systolic annular CT dimensions and nominal dimensions of the implanted THV. PVR, effective orifice area, and mean gradient were assessed on 30-day transthoracic echocardiography. Of 485 patients with available CT and echocardiography data, mean oversizing was 7.9 ± 8.7% for the annulus area and 2.1 ± 4.1% for the perimeter. A very low incidence of≥moderate PVR (0.6%) was observed, including patients with minimal annular oversizing. Incidence of≥mild PVR and need for procedural post-dilatation were inversely related to the degree of oversizing. For patients with annular dimensions suitable for 2 THV sizes, the larger THV with both area and perimeter oversizing was associated with the lowest incidence of≥mild PVR (12.0% vs 43.4%; P<0.0001). Left ventricular outflow tract area oversizing was not associated with PVR. THV prosthesis size, rather than degree of oversizing, had greatest impact on effective orifice area and mean gradient. In low-surgical-risk patients, a low incidence of≥moderate PVR was observed, including patients with minimal THV oversizing. The degree of prosthesis oversizing had the greatest impact on reducing mild PVR and incidence of post-dilatation, without impacting valve hemodynamics. In selected patients with annular dimensions in between 2 valve sizes, the larger THV device oversized to both the annular area and perimeter reduced PVR and optimized THV hemodynamics.

Comparison of postoperative outcomes following multidetector computed tomography based vs transesophageal echocardiography based annulus sizing for transcatheter aortic valve replacement: A systematic review and meta-analysis.

BackgroundThe purpose of this paper was to evaluate the difference in postoperative outcomes following multidetector computed tomography (MDCT) and transesophageal echocardiography (TEE)‐based annulus sizing for transcatheter aortic valve replacement (TAVR).MethodsElectronic search of PubMed, Biomed Central, Scopus, and Google Scholar databases was conducted until August 15, 2019. We included all types of studies comparing MDCT‐based annulus sizing with TEE‐based annulus sizing and assessing paravalvular regurgitation (PVR). Data were summarized using the Mantel‐Haenszel odds ratio (OR) with 95% confidence intervals (CI).ResultsA total of six studies were included. Pooled analysis of 431 participants in the MDCT group and 509 participants in the TEE group demonstrated that MDCT‐based annulus sizing is associated with a significantly lower incidence of more than moderate PVR as compared to 2DTEE‐based sizing (OR: 0.31, 95% CI: 0.18‐0.54, P < .0001; I 2 = 0%). There was no statistical difference in annulus rupture (OR: 0.57, 95% CI: 0.12‐2.66, P = .91; I 2 = 0%), procedural mortality (OR: 0.97, 95% CI: 0.19‐4.86, P = .97; I2 = 0%), and 30‐day mortality (OR: 0.63, 95% CI: 0.26‐1.50, P = .29; I 2 = 0%) with MDCT or 2DTEE‐based annulus sizing. Compared with 3DTEE, the incidence of PVR in the MDCT group was lower, but there was no statistical difference in 30‐day mortality.ConclusionUse of MDCT in comparison with 2DTEE is associated with significantly lower incidence of more than moderate PVR after TAVR. There seems to be no difference in annulus rupture and 30‐day mortality with either imaging modality.

Impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement with different next-generation devices

ObjectiveResidual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on...

Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Comparing Transthoracic versus Transesophageal Echocardiographic Guidance

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in cardiac catheterization laboratories using transthoracic echocardiography (TTE) to guide valve deployment. The risk of paravalvular regurgitation (PVR) remains a concern. We retrospectively reviewed 454 consecutive patients (mean age, 82±8; 58% male) who underwent transfemoral TAVR at Emory Healthcare from 2007 to 2014. Two hundred thirty-four patients underwent TAVR in the cardiac catheterization laboratory with TTE guidance (TTE-TAVR; mean Society of Thoracic Surgeons score, 10%), while 220 patients underwent the procedure in the hybrid operating room with transesophageal echocardiography (TEE) guidance (TEE-TAVR; mean Society of Thoracic Surgeons score, 11%). All patients received an Edwards valve (SAPIEN 55%, SAPIEN-XT 45%). Clinical and procedural characteristics, echocardiographic parameters, and incidence of PVR were compared. The incidence of at least mild PVR at discharge was comparable between TTE-TAVR and TEE-TAVR (33% vs 38%, respectively; P=.326) and did not differ when stratified by valve type. However, in the TTE-TAVR group, there was a higher incidence of second valve implantation (7% vs 2%; P=.026) and postdilation (38% vs 17%; P<.001) during the procedure. Although not independently associated with PVR at discharge (odds ratio = 1.12; 95% CI, 0.69-1.79), TTE-TAVR was associated with PVR-related events: the combined outcome of mild PVR at discharge, intraprocedural postdilation, and second valve insertion (odds ratio= 1.58; 95% CI, 1.01-2.46). There were no significant differences in PVR at 30days, 6months, and 1year between the two groups. TTE-TAVR in a high-risk group of patients was associated with increased incidence of intraprocedure PVR-related events, although it was not associated with higher rates of PVR at follow-up. Multicenter randomized trials are required to confirm the cost-effectiveness and safety of TTE-TAVR.

Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments

BackgroundParavalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair.ObjectivesTo compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure.MethodsThis is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure.ResultsThe group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08).ConclusionSurgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk.

Intentional Computed Tomography-based Oversizing in Balloon-expandable Transcatheter Aortic Valve Implantation - Incidence of Paravalvular Regurgitation and Post-deployment Geometry

Ziele: To evaluate the outcome in regard to paravalvular regurgitation and post-deployment geometry of intentional computed tomography (CT)-based oversizing of Transcatheter Heart Valves (THV) in Transcatheter Aortic Valve Implantation (TAVI) using pre- and post-deployment dual-source CT. Methode: Seventy-nine patients with severe aortic stenosis (mean age 81 ± 8 years, mean aortic valve area 0.69 ± 0.18 cm2) underwent retrospectively gated DSCT for THV sizing prior to TAVI. Aortic annulus dimensions were quantified by means of planimetry and area-derived diameter calculation (calculated average annulus diameter, CAAD = 2 x (area/pi) at the level of the basal attachment points of the aortic cusps during systole. THV selection was CAAD-based (EdwardSAPIEN XT 23 mm THV for CAAD <22mm, 26mm THV for CAAD 22–25mm, 29mm THV for CAAD >25 mm). Post-deployment CT was performed in 70 patients. Stent-unfolding was assessed planimetrically at the inlet, outlet and level of the native annulus. Relative oversizing and relative changes in annulus dimensions were calculated. Ergebnis: Average pre-deployment CAAD was 24.1 ± 1.7 mm, average post-deployment CAAD was 23.9 ± 1.5 mm (p = n.s.). Average relative change in CAAD was -0.4 ± 3.4%. Mean relative oversizing was 9.2 ± 4.8%. Mean diameter at the THV outlet was significantly larger than at the THV inlet (24.5 ± 1.7 mm vs. 23.9 ± 1.6 mm, p<0.001). Mild to moderate paravalvular regurgitation was observed in 6 patients (9%). There was no moderate or severe paravalvular regurgitation or uncontained aortic root rupture. Schlussfolgerung: Intentional oversizing of the THV based on an area-derived annulus diameter in CT and an adapted incremental sizing scheme is safe and is associated with a lower incidence of relevant paravalvular regurgitation, as compared to published landmark trials with echocardiography-based THV-sizing.

Paravalvular regurgitation one year after transcatheter aortic valve implantation

The aim of this study was to assess the natural history of paravalvular regurgitation at 1 year in patients undergoing TAVI. The immediate incidence of paravalvular regurgitation is estimated to be between 65 and 85% following transcatheter aortic valve implantation (TAVI). There is limited data as to whether this deteriorates during follow-up. Forty-six patients were recruited from a TAVI programme at our institute. All patients underwent an assessment of prosthetic valve function periprocedurally with aortography and immediately postprocedurally with transthoracic echocardiography. Twenty-one patients with a median age was 83 (66-91) years of whom 14 were male reached 1 year follow-up, 13 of whom were available for repeat transthoracic echocardiography. The incidence of paravalvular regurgitation immediately following TAVI was 86%. Of them 57% had < or = mild regurgitation and 29% had > mild regurgitation. At 1 year the incidence of paravalvular regurgitation was 77%. 54% had < or = mild regurgitation and 34% > mild regurgitation. No patient had severe regurgitation. The degree of regurgitation reduced in 6 (46%), stayed the same in 3 (23%), and increased in 4 (31%) of patients. Patients undergoing TAVI have an immediate postprocedural risk of regurgitation of 86%. In the majority of cases the degree of paravalvular CoreValve regurgitation is mild, and remains stable in 70% of patients during medium term follow-up.