In a multivariate binary logistic regression analysis, chronic hemodialysis (hazard ratio HR: 8.37; 95% confidence interval CI: 2.54 to 27.63; p < 0.001) and peripheral artery disease (HR: 3.77; 95% ...CI: 1.88 to 7.58; p < 0.001) remained the only independent predictors for developing IE. Negative imaging 15/47 (31.9) Total patients with affected prosthetic valve 22/47 (46.8) Vegetation only on prosthetic valve 12/47 (25.5) Vegetation on prosthetic valve and other valve 7/47 (14.9) Vegetation on prosthetic valve and PM/ICD lead 1/47 (2.1) Vegetation on prosthetic valve, PM/ICD lead and other valve 2/47 (4.3) Paravalvular abscess 9/47 (19.1) Vegetation on other valve than prosthetic valve 4/47 (8.5) Vegetation on PM/ICD lead 3/47 (6.4) Vegetation on PM/ICD lead and other valve 3/47 (6.4) Table 1 Characteristics of Patients Without and With Development of Infective Endocarditis Values are mean ± SD, median (interquartile range), or n (%).AR = aortic regurgitation; CKD = chronic kidney disease stage; COPD = chronic obstructive lung disease; ICD = implantable cardioverter-defibrillator; IE = infective endocarditis; PAD = peripheral artery disease; PM = pacemaker; STS = Society of Thoracic Surgeons; TOE = transesophageal echocardiography; ViV = valve-in-valve.
Significant coronary artery disease (CAD) is a common finding in patients undergoing transcatheter aortic valve implantation (TAVI). Assessment of CAD prior to TAVI is recommended by current ...guidelines and is mainly performed via invasive coronary angiography (ICA). In this study we analyzed the ability of coronary CT-angiography (cCTA) to rule out significant CAD (stenosis ≥ 50%) during routine pre-TAVI evaluation in patients with high pre-test probability for CAD.
In total, 460 consecutive patients undergoing pre-TAVI CT (mean age 79.6 ± 7.4 years) were included. All patients were examined with a retrospectively ECG-gated CT-scan of the heart, followed by a high-pitch-scan of the vascular access route utilizing a single intravenous bolus of 70 ml iodinated contrast medium. Images were evaluated for image quality, calcifications, and significant CAD; CT-examinations in which CAD could not be ruled out were defined as positive (CAD
). Routinely, patients received ICA (388/460; 84.3%; Group A), which was omitted if renal function was impaired and CAD was ruled out on cCTA (Group B). Following TAVI, clinical events were documented during the hospital stay.
cCTA was negative for CAD in 40.2% (188/460). Sensitivity, specificity, PPV, and NPV in Group A were 97.8%, 45.2%, 49.6%, and 97.4%, respectively. Median coronary artery calcium score (CAC) was higher in CAD
-patients but did not have predictive value for correct classification of patients with cCTA. There were no significant differences in clinical events between Group A and B.
cCTA can be incorporated into pre-TAVI CT-evaluation with no need for additional contrast medium. cCTA may exclude significant CAD in a relatively high percentage of these high-risk patients. Thereby, cCTA may have the potential to reduce the need for ICA and total amount of contrast medium applied, possibly making pre-procedural evaluation for TAVI safer and faster.
: Coronary artery disease (CAD) is a frequent comorbidity in patients undergoing transcatheter aortic valve implantation (TAVI). If significant CAD can be excluded on coronary CT-angiography (cCTA), ...invasive coronary angiography (ICA) may be avoided. However, a high plaque burden may make the exclusion of CAD challenging, particularly for less experienced readers. The objective was to analyze the ability of machine learning (ML)-based CT-derived fractional flow reserve (CT-FFR) to correctly categorize cCTA studies without obstructive CAD acquired during pre-TAVI evaluation and to correlate recategorization to image quality and coronary artery calcium score (CAC).
: In total, 116 patients without significant stenosis (≥50% diameter) on cCTA as part of pre-TAVI CT were included. Patients were examined with an electrocardiogram-gated CT scan of the heart and high-pitch scan of the torso. Patients were re-evaluated with ML-based CT-FFR (threshold = 0.80). The standard of reference was ICA. Image quality was assessed quantitatively and qualitatively.
: ML-based CT-FFR was successfully performed in 94.0% (109/116) of patients, including 436 vessels. With CT-FFR, 76/109 patients and 126/436 vessels were falsely categorized as having significant CAD. With CT-FFR 2/2 patients but no vessels initially falsely classified by cCTA were correctly recategorized as having significant CAD. Reclassification occurred predominantly in distal segments. Virtually no correlation was found between image quality or CAC.
: Unselectively applied, CT-FFR may vastly increase the number of false positive ratings of CAD compared to morphological scoring. Recategorization was virtually independently from image quality or CAC and occurred predominantly in distal segments. It is unclear whether or not the reduced CT-FFR represent true pressure ratios and potentially signifies pathophysiology in patients with severe aortic stenosis.
Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. ...Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce.
The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis.
A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 95% CI, 1.07-2.44,
=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 95%CI: 0.91-2.73,
=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, 95% CI, 0.40-1.82,
=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 32-180 versus 240 174-316 seconds,
<0.001).
Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.
Background
Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial.
Aims
...We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide).
Methods
We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately.
Results
Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 95%CI 0.43–0.89,
p
= 0.01,
I
2
= 0%), but more frequent in the analysis of RCT data (RR 1.70 95%CI 1.16–2.51,
p
= 0.01,
I
2
= 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 95%CI 0.32–1.02,
p
= 0.06,
I
2
= 70%; and RCT: RR 1.37 95%CI 0.82–2.28,
p
= 0.23,
I
2
= 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 95%CI 1.07–11.33,
p
= 0.04,
I
2
= 0%).
Conclusions
While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique.
Graphical abstract
The aim of this study was to examine the predictive value of preprocedural computed tomography (CT)-based risk stratification of coronary obstruction during transcatheter aortic valve replacement ...(TAVR) on the basis of geometric measurements on postprocedural CT.
Proper patient selection for additional procedures to prevent coronary obstruction during TAVR has not been adequately evaluated.
Pre- and postprocedural computed tomographic scans of 28 patients treated using bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and TAVR were analyzed. Using the postprocedural computed tomographic images, threatened coronary obstruction (TCO) was defined as: 1) ostial obstruction (adherence of the transcatheter heart valve THV to the coronary ostium with leaflet extension above the ostium); and/or 2) sinus sequestration (THV adherence to the sinotubular junction STJ with leaflet extension above the STJ) and was substratified into complete and incomplete types.
A total of 51 leaflets were evaluated (88% surgical tissue valves) after excluding leaflets not visible on CT (n = 5). On postprocedural CT, complete TCO was observed in 25.4% (13 of 51 leaflets). On preprocedural CT, leaflets were at high risk for complete TCO (incidence 53%) if the virtual THV-to-coronary distance (VTC) was <3.0 mm, or if the virtual THV-to-STJ distance (VTSTJ) was <1.0 mm with STJ height - leaflet length <0 mm (leaflet-STJ mismatch). Leaflets were at low risk (incidence 0%) if the VTC was ≥3 mm and VTSTJ was ≥3.0 mm or STJ height - leaflet length was ≥+2.0 mm. Of 28 leaflets treated using BASILICA, complete TCO was seen in 35.7% (n = 10), due to sinus sequestration (100%) with coexisting ostial obstruction (30%). Actual coronary events occurred in 7.1% (n = 2) because of leaflet prolapse, corresponding to an absolute risk reduction by BASILICA of 29% (P = 0.021).
Risk assessment of coronary obstruction after TAVR may improve with a multiparametric approach incorporating VTC, VTSTJ, and leaflet-STJ mismatch. BASILICA appeared to reduce actual coronary events even in leaflets with anticipated coronary obstruction.
Vascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a ...novel option to achieve haemostasis for large-bore arterial access sites.
We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD.
From February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition.
Overall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32–0.91, p = 0.022).
The M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.
•The plug-based Manta closure device is a new option for large-bore arterial access.•Access site-related vascular complications were less frequently with the Manta device.•The ProGlide device is associated with more severe bleeding complications.
PDF
