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Large Bore Vascular Access Closure Device Strategies
Abstract
Background
The optimal strategy for large bore vascular closure following TAVR is a matter of contention as major bleeding and vascular complications remain a challenge. We compared three strategies for post-TAVR vascular closure in terms of safety and efficacy: a dual Proglide based strategy, a hybrid strategy of Proglide and Angioseal, and a MANTA strategy.
Methods
Patients were enrolled to one of three strategies: two Proglides, a single Proglide with an 8F Angioseal, or a single 18F MANTA.
Results
172 patients were enrolled into this study: 86 in the MANTA group, 40 in the Proglide/Angioseal group, 46 in the dual Proglide group. Hemostasis was achieved in 95% of patients. MANTA was associated with vessel occlusion in 2% of cases. The dual Proglide group required an extra device to achieve hemostasis in 35% of cases.
Conclusion
The three strategies of MANTA, dual Proglides, or Proglide/Angioseal are all effective, but there are important differences between them which mandate careful consideration by operators.
... With lower profile delivery catheters, ultrasound-guided puncture, pre-TAVI CT angiography and dedicated large-bore closure devices, vascular access has become safer. [17][18][19] Transapical TAVI was initially the only alternative access if transfemoral access was not possible. Now with slimmer profiles of delivery systems, less stiff guidewires and increased experience with alternative percutaneous access, transapical access is used less often. ...
... We identified 11 studies (2 RCTs and 9 observational studies) for the meta-analysis. 8,[11][12][13][14][15][16][17][18][19][20] The literature search process is detailed in Figure 1. The details of the included studies are illustrated in Table 1. ...
Background: Vascular access closure is essential in large-bore arteriotomy procedures, such as transcatheter aortic valve replacement. Suture-based devices are frequently used for vascular access closure. MANTA (Teleflex) is a collagen plug–based device used to achieve hemostasis with evolving efficacy and safety data. This study aimed to evaluate plug-based versus suture-based closure devices following large-bore arteriotomy procedures.
Methods: We conducted a systematic review searching PubMed, Cochrane Library, and ClinicalTrials.gov (inception through November 2021) for studies evaluating plug-based versus suture-based closure devices following large-bore arteriotomy procedures. We performed a meta-analysis comparing the length of stay, device failure, mortality, bleeding, and vascular complications between these 2 types of devices.
Results: Eleven studies (2 randomized controlled trials and 9 observational studies) with a total of 3123 patients were included in this analysis. Compared with suture-based devices, plug-based devices were associated with a significant decrease in the length of stay (standardized mean difference: −0.14; 95% CI, −0.25 to −0.03) and vascular closure device failure (odds ratio, 0.63; 95% CI, 0.44-0.91) following the procedure. There were no significant differences in all-cause mortality, major or minor bleeding, and major or minor vascular complications between plug-based and suture-based closure devices.
Conclusions: Plug-based vascular closure devices were associated with a shorter length of stay and lower risk of device failure following large-bore arteriotomy procedures without differences in mortality, bleeding, or vascular complications than suture-based closure devices.
Background
The hybrid strategy combining plug‐based and suture‐based vascular closure devices (VCD) was introduced as a promising technique for vascular access hemostasis after transcatheter aortic valve implantation (TAVI) with satisfactory outcomes. However, data comparing two plug‐based VCDs each in the combination with a suture‐based VCD, namely ProGlide/AngioSeal (P/AS) with ProGlide/FemoSeal (P/FS) VCDs, is still lacking.
Aims
To compare the 30‐day outcome of the hybrid strategy using P/AS versus P/FS for vascular access site closure after TAVI.
Methods
A retrospective single‐center observational study included 608 patients recruited from a prospective TAVI registry between 2016 and 2022. The composite endpoint was defined as any VCD‐related major vascular complications and/or bleeding more than type 1 according to Valve Academic Research Consortium criteria.
Results
The current study reported a significantly higher rate of composite endpoint in P/AS group, which was driven by a higher rate of major bleeding (5.4% vs. 1.4%, p = 0.036). We also found a higher rate of VCD‐related minor bleeding in P/AS group (16.3% vs. 8.1%, p = 0.013). Successful access site hemostasis was achieved in 71.7% of P/AS group versus 83.1% in P/FS group ( p = 0.006). The presence of anterior wall calcification at the access site was significantly associated with the composite endpoint (adj odds ratio 2.49; 95% confidence interval (1.08–5.75), p = 0.032).
Conclusion
The hybrid strategy for large bore vascular access closure using P/FS showed a potentially better 30‐day outcomes compared with P/AS. The presence of anterior calcification at the access site carries a significant risk of VCD‐related complications.
TAVI requires a large-bore arteriotomy. Closure is usually performed by the suture system. Some studies report a vascular complication rate of up to 21%. MANTA is a recently developed percutaneous closure system dedicated to large caliber vessels based on an anchoring system. Early studies report a lower rate of vascular complications with MANTA devices. This single-center retrospective study included all patients who underwent femoral TAVI at the Brest University Hospital from 20 November 2019 to 31 March 2021. The primary endpoint is the rate of vascular complications (major and minor) pre and post-TAVI procedure. In total, 264 patients were included. There were no significant differences in vascular complications (major and minor) between the two groups (13.6% in the MANTA group versus 21.2% in the PROSTAR group; p = 0.105), although there was a tendency to have fewer minor vascular complications in the Manta group (12.1% versus 20.5%; p = 0.067). Manta was associated with a lower rate of bleeding complications (3.8% versus 15.2%; p = 0.002), predominantly minor complications with fewer closure failures (4.5% versus 13.6%; p = 0.01), less use of covered stents (4.5% versus 12.9%; p = 0.016), and with no difference in the need for vascular surgery compared to the Prostar group (1.5% versus 2.3%; p = 0.652). On the other hand, Manta was associated with a higher rate of femoral stenosis (4.5% versus 0%; p = 0.013) without clinical significance (1.5% versus 0%; p = 0.156). The Manta and Prostar devices are equivalent in terms of vascular complications. The Manta, compared to the Prostar, is associated with fewer bleeding complications.
Background:
Post-infarction ventricular septal defect (PIVSD) carries a very poor prognosis. Surgical repair offers reasonable outcomes in patients who survive the initial healing period. Percutaneous device implantation remains a potentially effective earlier alternative.
Methods and results:
From March 2018 to May 2022, 11 trans-arterial PIVSD closures were attempted in 9 patients from two centers (aged 67.2 ± 11.1 years; 77.8% male). Two patients had a second procedure. Myocardial infarction was anterior in four patients (44.5%) and inferior in five cases (55.5%). Devices were successfully implanted in all patients. There were no major immediate procedural complications. Immediate shunt grade postprocedure was significant (11.1%), minimal (77.8%), or none (11.1%). Median length of stay after the procedure was 14.8 days. Five patients (55%) survived to discharge and were followed up for a median of 605 days, during which time no additional patients died.
Conclusion:
Single arterial access for percutaneous closure of PIVSD is a good option for these extremely high-risk patients, in the era of effective large-bore arterial access closure. Mortality remains high, but patients who survive to discharge do well in the longer term.
Background: Vascular complications (VCs) after transcatheter aortic valve implantation (TAVI) are associated with impaired outcome. We performed a meta-analysis to determine in-hospital/30-day major VCs rate after transfemoral-TAVI adjudicated by an independent clinical-event-committee, and to compare the major VCs rate with regard to consecutive generations of balloon-expandable and self-expanding platforms, device profile, experience and patient risk-profile.
Methods: A systematic, computerized search with predefined criteria was performed in PubMed, Embase and Cochrane on March 27, 2018. The overall pooled proportion of VC was calculated using a random-effects model. Subgroups were examined based on sheath size (low (≤ 16 French); high-profile (> 16French)), STS-score (high (STS>8%); intermediate-risk (STS 4-8%) studies) and start-date of inclusion (early (< January 2012); late-phase (≥January 2012) studies).
Results: A total of 24 unique studies with 14308 patients were included. The pooled major VCs rate was 7.71% and was lower in low-profile vs. high-profile device studies (5.51% vs. 8.46%, p=0.0015). Major VCs rate decreased significantly with transition to newer generation balloon-expandable valves ((Sapien vs. SapienXT (15.18% vs. 8.48%, p<0.00001); SapienXT vs Sapien3 (8.48% vs. 4.48%, p= 0.005)) and there was a tendency towards fewer major VCs in EvolutR vs. CoreValve (5.98% vs. 7.97%, p=0.094). Major VC rate was lower in late-phase vs. early-phase studies (5.82% vs 7.84%, p=0.048) and a tendency towards a lower rate was seen in intermediate vs. high-risk studies (7.09% vs. 9.62%, p=0.059).
Conclusion: The pooled rate of independently adjudicated major VCs after transfemoral-TAVI was 7.71%. Experience and device profile are associated with fewer major VCs.
The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear.
To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy.
The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics.
Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007).
Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.
Transcatheter aortic valve implantation (TAVI) has emerged as a new therapy for patients with severe aortic stenosis who are inoperable or at very high risk of open heart surgery. Vascular complications are a potential limitation of TAVI and have been associated with bleeding, transfusions, and mortality. Transfemoral TAVI can be considered the least invasive approach and is therefore the most widely used access for TAVI. With the current 18-F to 24-F sheaths, the majority of patients can be treated via the transfemoral route. Initially, open surgical access was routinely used to introduce the large sheaths and catheters. Subsequently, percutaneous techniques have emerged as the new standard, resulting in a less invasive, fully percutaneous procedure. Stiff wires allow insertion of the sheath and delivery of the device without causing trauma to the artery. Given the high burden of vascular disease in TAVI candidates, increasing the effectiveness of pre-procedural screening is key. This often begins with conventional angiography, but computed tomography allows visualization of the artery in 3 dimensions, thereby overcoming some of the limitations of conventional angiography. Approximately one third of patients do not have adequate anatomy to allow safe transfemoral access. In such patients, alternative access routes such as the transapical, transaxillary, or direct aortic access are preferred. These alternative routes all have specific advantages and disadvantages.
The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection.
A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous.
Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints.
This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).
Introduction:
Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR.
Methods:
Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria.
Results:
A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups.
Conclusion:
Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk.
Objectives
The aim of this paper is to report insights from the first 100 consecutive cardiovascular procedures with MANTA closure.
Background
The collagen-based MANTA vascular closure device (Teleflex, Wayne, Pennsylvania) has recently been approved for the closure of large-bore femoral access.
Methods
Procedural and access site–related complications were analyzed according to Valve Academic Research Consortium–2 criteria. Duration of bleeding after device closure was recorded.
Results
Patients underwent transcatheter aortic valve replacement (n = 75), endovascular aortic replacement (n = 21), or Impella left ventricular support (n = 4). In these 100 patients, a total of 122 MANTA devices were used (22 patients had bilateral large-bore access). None of the patients received protamine. Immediate hemostasis was achieved in 70 patients and hemostasis within 5 min in 87 patients. There were 7 patients with major and 4 patients with minor MANTA-associated vascular complications: femoral artery occlusion in 2, ongoing bleeding in 5, and pseudoaneurysm formation in 4 patients. One patient was treated with covered stent implantation, 7 required surgical revision, and 4 received thrombin injection. Complications occurred significantly more often in patients with peripheral artery disease and a minimal artery diameter <6 mm. Careful review of these complications suggests 3 distinct failure mechanisms. In vessels with narrow femoral artery diameters, elevation of the toggle may lead to occlusion of the artery, incomplete apposition of the plug may lead to perivascular (potentially retroperitoneal) bleeding, or pseudoaneurysm formation may occur.
Conclusions
In this paper, MANTA-associated complications are addressed, 3 distinct failure mechanisms are suggested, and strategies to avoid these complications and improve procedural outcomes are discussed.
Objectives:
To evaluate the clinical utility and feasibility of a hybrid technique for obtaining vascular hemostasis by combining a suture- and a collagen-mediated system after transfemoral transcatheter aortic valve implantation (TF TAVI) in a real-world setting.
Methods:
In 75 consecutive TF TAVI procedures, we investigated a hybrid closing method to achieve hemostasis at the large bore puncture site using a combination of one presuture closure system (ProGlide) and one collagen-mediated system (Angio-Seal). Vascular complications at puncture site were recorded until discharge.
Results:
Successful hemostasis by the hybrid technique was achieved in 74 out of 75 patients, and the method was well tolerated by all patients. In 73 patients, (97.3%) neither puncture site related complications nor serious early or late bleedings were observed during a median hospital stay of 2 days postprocedure.
Conclusion:
This single-center registry study indicates that a percutaneous hybrid closure technique is safe and efficacious in closing large bore arteriotomies. It is an easy and reliable technique that may contribute to simplifying TAVI procedures.
Study registration:
The data was collected from an internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål.
Background:
Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device.
Methods and results:
A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%).
Conclusions:
In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices.
Clinical trial registration:
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.
Background/Objective:
Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear.
Methods
The BRAVO‐3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30‐day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke).
Results
A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37–0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death.
Conclusions
Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.
Aims:
Vascular and bleeding complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). However, data regarding the efficacy and safety of the percutaneous vascular closure device, MANTA is scarce.
Methods and results:
We performed a retrospective, propensity score-matched study to compare vascular and bleeding complications in 325 consecutive patients who underwent TAVR using MANTA and ProGlide. The 1:1 propensity score-matching resulted in 111 matched pairs. For MANTA- versus ProGlide-treated patients, all-cause mortality (0% vs. 4%, p=0.02), vascular complications (14% vs. 21%, p=0.21), and bleeding complications (18% vs. 33%, p=0.01) were observed. Access site vascular injury was significantly less frequent in patients who received MANTA versus ProGlide (8% vs. 17%, p=0.04). MANTA presented significantly lower hemoglobin decrease (16.4 vs. 20.0 g/l, p=0.04) and shorter hospital stay after TAVR (3.3 vs. 5.8 days, p=0.02). It also predicted fewer bleeding complications (OR: 0.44; 95% CI: 0.23 - 0.83; p=0.01). Moreover, significant decreases of all endpoints were not seen across the procedure date tertiles in the MANTA group.
Conclusions:
MANTA resulted in a significantly lower complication rate, especially for bleeding, than did ProGlide despite the operators' inexperience in the use of MANTA.
Background: The MANTA system is a novel vascular closure device (VCD) and its safety and efficacy were compared to the ProGlide VCD in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI).
Methods: This is a retrospective study including 222 patients who underwent transfemoral TAVI at three Finnish University Hospitals. The MANTA VCD was used in 107 patients and their outcome was compared with that of 115 patients in whom the arterial access was closed with the ProGlide VCD.
Results: VARC-2 VCD failure occurred less frequently in the MANTA cohort (3.7% vs. 7.8%, p=0.378), but the difference did not reach statistical significance. When adjusted for the introducer outer diameter, the MANTA cohort had similar rates of VARC-2 major vascular complications (9.3% vs. 12.2%, adjusted: p=0.456), VARC-2 life-threatening/disabling bleeding (9.3% vs. 6.1%, adjusted: p=0.296) and need of invasive treatment of bleeding (4.7% vs. 7.0%, adjusted: p=0.416) compared to the ProGlide cohort. Additional VCDs were more frequently needed in the ProGlide cohort (58.3% vs. 1.9%, p<0.0001).
Conclusions: In patients undergoing transfemoral TAVI, the MANTA VCD showed a similar risk of VARC-2 vascular and bleeding complications compared to the ProGlide VCD, but it reduced significantly the need of additional VCDs for completion of hemostasis.
Objectives
To evaluate the feasibility of fully percutaneous closure using a novel collagen‐based vascular closure device after transfemoral aortic valve replacement (TAVR).
Background
TAVR is utilized increasingly for the treatment of severe symptomatic aortic stenosis. Vascular complications related to access and closure dominate the adverse event profile of the procedure despite progressively reducing arteriotomy caliber. The advent of a novel collagen‐based device (MANTATM) and preliminary data suggest this could be used as a routine percutaneous closure device.
Methods
A prospective observational study of unselected consecutive patients undergoing TAVR in a single center. Data were collected via hospital electronic records and the SWEDEHEART registry. The primary clinical outcome was closure success and time to hemostasis. Secondary outcomes included VARC‐2 defined major and minor vascular and bleeding complications within 30 days using suture‐based closure with Prostar‐XL within the same center.
Results
A consecutive cohort of 346 patients underwent TAVR via the transfemoral approach. Vascular closure with MANTATM was successful in all with a mean time to hemostasis of 42 sec (SD 115.5, range 0–600). The composite of all‐cause mortality and major complications related to the main access site was similar between the groups (1.1% vs 1.9%, P = .61). Major bleeding occurred less frequently with MANTA TM (1.1% vs 7.8%, P = .02).
Conclusion
The novel use of a collagen‐based vascular closure device for large caliber arteriotomy is feasible in an unselected population undergoing transfemoral TAVR and appears efficacious compared to percutaneous suture‐based closure. These data should prompt larger studies to evaluate efficacy and safety.
Objectives:
The authors sought to study the safety and efficacy of the MANTA Vascular Closure Device (VCD), a novel collagen-based technology dedicated to closure of large-bore arteriotomies.
Background:
Novel transfemoral therapeutic interventions requiring large-bore catheters have become valid minimally invasive options but have inherent access management challenges. To date, no dedicated vascular closure devices exist for large arteriotomies.
Methods:
A prospective, single-arm clinical investigation enrolling patients who underwent elective percutaneous interventions with large-bore catheters and planned percutaneous arteriotomy closure in 3 European institutions.
Results:
A total of 50 patients with a mean age of 79.5 ± 8.3 years underwent high-risk percutaneous coronary intervention, balloon aortic valvuloplasty, or transcatheter aortic valve replacement with large-bore catheters sized 12-F to 19-F. MANTA closure was performed by 9 different operators. The 14-F MANTA VCD was deployed in one-third of the overall cohort (16 of 50, 32%), and the 18-F MANTA VCD in the remainder. The MANTA VCD was deployed successfully in all patients. The mean time to hemostasis was 2 min, 23 s. One patient had a major vascular and major bleeding complication with prolonged femoral bleeding that was successfully treated with a covered stent and eventual surgical repair. There were no other access site-related complications.
Conclusions:
This first multicenter experience demonstrates rapid and reliable hemostasis and low complication rates with the use of the plug-based MANTA VCD for large-bore arteriotomy closure.
Objectives:
This study aimed to assess the feasibility of percutaneous arterial access site closure after percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI) using single versus double Perclose ProGlide devices.
Backgrounds:
Although suturing with the preclose technique has been widely adopted during TF-TAVI, the optimal vascular closure strategy is still under debate.
Methods:
Data from 279 patients who underwent TF-TAVI, obtained from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicenter registry. Technical, procedural, and clinical outcomes were compared between the single ProGlide group (n = 99) and double ProGlide group (n = 180). They were also analyzed by propensity adjusted matching model (single [n = 69] vs. double [n = 69]). All patients were treated through a 16-Fr to 20-Fr eSheath. Technical success of the closure device was defined as hemostasis not requiring alternative invasive treatment. Access site-related vascular complications, bleedings, and other procedural complications were defined according to the Valvular Academic Research Consortium-2 (VARC-2) criteria.
Results:
The rates of technical success and access site-related vascular complications were similar in the 2 groups (94.9% vs. 91.6%, p = 0.44; 5.0% vs. 7.7%, p = 0.54, respectively). The prevalence of bleeding complications did not differ between the 2 groups (1.0% vs. 3.3%, p = 0.43). Thirty-day mortality rate also showed no difference between the 2 groups (2.0% vs. 1.1%, p = 0.95), although these events were not associated with access site failure. These results were not attenuated in the propensity matching model.
Conclusions:
Vascular closure with a single ProGlide in TF-TAVI could achieve equivalent, acceptable rates of technical success and procedural complications compared with the double ProGlide technique. © 2016 Wiley Periodicals, Inc.
Catheter-based interventions have become a less invasive alternative to conventional surgical techniques for a wide array of cardiovascular diseases but often create large arteriotomies. A completely percutaneous technique is attractive as it may reduce the overall complication rate and procedure time. Currently, large bore arteriotomy closure relies on suture-based techniques. Access-site complications are not uncommon and often seem related to closure device failure. The MANTA VCD is a novel collagen-based closure device that specifically targets arteriotomies between 10 and 22 Fr. This technical report discusses the MANTA design concept, practical instructions for use and preliminary clinical experience.
Background:
Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.
Methods:
In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes.
Findings:
At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of -9·2%; 90% CI -12·4 to -6; p<0·0001) and superior (-9·2%, 95% CI -13·0 to -5·4; p<0·0001) to surgical valve replacement.
Interpretation:
TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients.
Funding:
None.
Background
Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.
Methods
We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.
Results
The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.
Conclusions
In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)
This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR).
VC after TF-TAVR are frequent and may be associated with unfavorable prognosis.
From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed.
Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p = 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p = 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p = 0.002) were identified as independent predictors of 1-year mortality.
Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
Advances in percutaneous coronary intervention (PCI) during the past decade have led to more widespread use of these procedures in older and sicker patients. Refinement of periprocedural antithrombotic therapy has played a particularly important role in reducing ischemic complications to very low levels in routine practice. Although the use of more powerful antiplatelet agents has been associated with increased risk of bleeding (especially among the elderly and patients with serious comorbidities), such complications have traditionally been viewed as benign in nature. Recent studies, however, have identified major bleeding after PCI as an important predictor of increased mortality. Whether this relationship between bleeding and risk of death is cause-and-effect, or merely an association based on shared risk factors, remains unclear. In this review, we examine the basis for a possible causal link between post-PCI bleeding and subsequent mortality. Possible mechanisms underpinning such a link are discussed, including a potential adverse role for blood transfusion in this setting. A framework for further clinical evaluation of this issue is presented.