Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement (original) (raw)
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Journal of the American Heart Association, 2020
Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year fo...
Cardiovascular Revascularization Medicine, 2020
Objectives: To determine the incidence, prognosis, and predictors of major Valve Academic Research Consortium (VARC-2) vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) following contemporary percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR). Background: Limited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14-16 French (F) sheaths. Methods: We recorded clinical and procedural characteristics, computer tomography (CT) angiographic data, 30-day VCs, mortality, and length of stay (LOS) in all consecutive percutaneous TF-TAVRs at a single center from June 2016 to October 2018. CT measures included common femoral artery (CFA) and external iliac artery (EIA) diameters, sheath to CFA and EIA ratios (SFAR and SEIAR), depth of CFA, extent and location of CFA calcification and pelvic vessel tortuosity (2 bends ≥90°). Multivariable regression was used to predict major VCs and percutaneous closure device failure (PCDF), respectively.
Catheterization and Cardiovascular Interventions, 2012
Background: Percutaneous aortic valve treatments, balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI), are effective ways to treat patients with symptomatic aortic stenosis when open surgical repair is not feasible or considered too high risk. Large bore vascular access is required, and successful management of this arterial access is key to overall procedural success. We report outcomes and complications using the Prostar vascular closure device following BAV and TAVI. Methods: During the period under consideration, 54 patients underwent BAV and 64 patients underwent TAVI (n 5 118). Procedural data and outcomes were collected prospectively on a dedicated database. Results: Patients were aged 80 6 6.9 years (BAV) and 80.8 6 6.1 years (TAVI) and 46.2% (BAV) and 46.8% (TAVI) were male, respectively. Primary success (hemostasis achieved immediately after deployment of the Prostar system on the table and persisting for a minimum of 24 hr in the absence of major or minor bleeding complications) was achieved in 94.4% (n 5 54) of the patients undergoing BAV and 92.2% (n 5 64) of the patients undergoing TAVI, respectively. The combined success rate was 93.3%. Major bleeding (see definitions section) was seen in 1.9% of cases in the BAV group and 4.7% of cases in the TAVI group. Minor bleeding (see definitions section) was seen in 3.7% of cases in the BAV group and 3.1% of cases in the TAVI group. Conclusions: Use of the Prostar vascular closure system to achieve hemostasis following percutaneous aortic valve interventions is associated with a high primary success rate and acceptable level of bleeding complications.
Circulation: Cardiovascular Interventions, 2014
Background— Vascular complications after transfemoral transcatheter aortic valve replacement are common and associated with significant morbidity and mortality. Little is known about the effect of access approach on vascular complications. Methods and Results— Between 2007 and 2013, 331 patients underwent transfemoral transcatheter aortic valve replacement via open surgical (OS) or fully percutaneous (PC) approaches. Patient data and clinical outcomes were collected. Valve Academic Research Consortium–defined vascular complications were noted. Multivariable analysis with propensity matching was performed, and vascular complications, mortality, and length of stay were assessed. One hundred twenty patients were treated with the OS approach and 211 patients via the PC approach. There were fewer major vascular complications (11% versus 20%; P =0.03) and shorter length of stay (7.5 versus 9.9 days; P =0.003) in the PC group when compared with those in the OS group. In multivariable analy...
Cut-down outperforms complete percutaneous transcatheter valve implantation
Asian Cardiovascular and Thoracic Annals, 2018
Background The ideal approach for transfemoral transcatheter aortic valve implantation is still widely debated. The objective of this study was to compare access and bleeding complications of complete percutaneous versus the surgical cut-down approach for transfemoral transcatheter aortic valve implantation. Methods The study included 667 consecutive patients from November 2008 to December 2016, 466 in the percutaneous group and 201 in the cut-down group. There were no significant differences in baseline characteristics between the 2 groups. Primary study endpoints were vascular access site and bleeding complications according to the Valve Academic Research Consortium II criteria. Results Mean procedure time was shorter in the cut-down group: 93.5 ± 22.0 (percutaneous) vs. 69 ± 19 min (cut-down), p
Heart Research – Open Journal, 2021
Aims Access site vascular complications remain a recognised complication following transcatheter aortic valve implantation (TAVI). Suture-based vascular closure devices (VCDs) such as ProGlide® (Abbott Vascular Inc., Santa Clara, CA, USA) are widely used in order to achieve rapid haemostasis. The MANTATM (Essential Medical Inc., Malvern, PA, USA) is a collagen plug-based VCD which can be used as an alternative to traditional suture-based devices, but is significantly more expensive per-unit. We compare the efficacy, safety and total cost associated with the use of the MANTATM and ProGlide® VCDs. Methods This retrospective study included all consecutive patients who underwent transfemoral (TF) TAVI between November 2017-June 2018. The primary endpoints were primary access site-related VARC-2 vascular complications, VARC-2 bleeding and the overall per-patient cost incorporating treatment for complications or use of additional VCDs. Results A total of 136 patients were included in this...
[Percutaneous aortic valve replacement]
Herz, 2006
Surgical aortic valve replacement has been the gold standard for treatment of symptomatic aortic valve disease. However, the success of this approach depends on various patient- and situation-specific risk predictors; thus, the perioperative mortality can reach up to 50%. Percutaneous valve replacement might offer a new less invasive alternative. Since 2002, a balloon-expandable valve prosthesis is under evaluation in symptomatic high-risk patients with aortic valve stenosis. After modifications of both the implantation technique as well as the design of the prosthesis, procedural success rates of > 75% and adverse event rates of < 20% at 30-day follow-up have been reported. A new alternative to this approach is the self-expanding valve prosthesis. The recently reported First-in-Man Study demonstrated the feasibility of this technique. However, the strict inclusion criteria for both procedures limit the number of potential candidates. New devices are currently under developmen...
Texas Heart Institute Journal
Background Vascular complications (VCs) after transfemoral transcatheter aortic valve implantation (TAVI) have an increased mortality risk, and vascular closure device (VCD) use is mandatory. The percutaneous MANTA VCD (Teleflex) is a novel collagen-based technology for closure of large-bore arteriotomies. We compared the MANTA VCD with the suture-based ProGlide VCD (Abbott Vascular). Methods A retrospective review was performed on all consecutive patients who underwent transfemoral TAVI in our center from January 1, 2015, to February 28, 2021, and 30-day outcomes were recorded. Major adverse cardiovascular events (MACE) were cardiac death, disabling stroke, and/or major VCs. Access site–related VCs were VCs related to the access site vessel from which the transcatheter valve was introduced and advanced. Results The MANTA VCD was used in 99 patients and the ProGlide in 224. There was 4.0% MACE in the MANTA group and 4.9% in the ProGlide group (P = .999). Overall VCs were 10.1% vs 7....