Percutaneous Transfemoral Transcatheter Aortic Valve Research Articles

Comparison of patients with occlusive or hemorrhagic access site complications requiring reintervention after percutaneous transfemoral transcatheter aortic valve implantation.

Background: Transcatheter aortic valve implantation (TAVI) via transfemoral (TF) access is increasingly integral to aortic valve disease treatment, expanding beyond high-risk patients. Despite technical advancements, access-related vascular complications, occurring in approximately 10% of TAVI procedures, remain a substantial challenge. Objective: This study investigated the clinical and morphological characteristics of percutaneous TF-TAVI patients experiencing occlusive (OC) and hemorrhagic (HC) complications managed with surgical or endovascular reintervention. Methods: The cohort included patients from a Dutch and a German tertiary referral hospital, managed with TF-TAVI procedures between 2017 and 2021 that required reintervention for OC or HC. Demographics, comorbidities, procedural details, and preoperative imaging data were collected and compared between groups. Results: Among 109 TF-TAVI patients, 32 with OC and 77 with HC required reintervention. The OC group presented significantly smaller access arterial diameters (common femoral artery: OC 6.7 mm vs. HC 8.9 mm, p<.001; external iliac artery: OC 7.2 mm vs. HC 8.3 mm, p<.001; common iliac artery: OC 9.4 mm vs. HC 10.5 mm, p=.012) while the HC group presented higher tortuosity index (TI) (OC 1.24 vs. HC 1.30; p=.017). No differences were observed regarding baseline characteristics, vessel calcification or vascular closure device use. Conclusions: In patients requiring reintervention following TF-TAVI, smaller arterial diameters were associated with OC, while higher TI was linked to HC. These findings emphasize the importance of preoperative imaging in developing individualized prevention strategies.

Vascular complications of ProGlide versus Prostar in transcatheter aortic valve replacement (TAVR) procedures: meta-analysis.

The aim of this study was to compare the vascular complications of ProGlide and Prostar in percutaneous transfemoral transcatheter aortic valve replacement. Electronic databases were searched in July 2022 for studies that compared the vascular complications of ProGlide and Prostar for percutaneous closure in transcatheter aortic valve replacement. The primary outcome was major vascular complications and the secondary outcomes were minor vascular complications, types of access-site vascular complications, device failure, and additional intervention. Estimates of relative effects were pooled to generate ORs and their 95 per cent c.i. using a random-effects model. The risk of bias in non-randomized comparative studies was assessed using the Risk Of Bias In Non-randomized Studies - of Interventions ('ROBINS-I') tool. Nine studies were identified and a total of 7529 patients were included. Among them, 4144 patients received ProGlide and 3385 received Prostar. The pooled data showed that the risk of major vascular complications was significantly lower with ProGlide versus Prostar (OR 0.50, 95 per cent c.i. 0.32 to 0.78). Regarding the types of vascular complications, vascular trauma was the most common complication and the risk was similar between groups (OR 1.02, 95 per cent c.i. 0.55 to 1.91). ProGlide had a lower risk of bleeding complications (OR 0.46, 95 per cent c.i. 0.22 to 0.94), but a higher risk of ischaemia complications (OR 1.90, 95 per cent c.i. 1.10 to 3.27). The risk of device failure was lower in the ProGlide group (OR 0.45, 95 per cent c.i. 0.21 to 0.95). Both groups had a similar risk of having additional interventions for vascular complications (OR 1.02, 95 per cent c.i. 0.75 to 1.39). The use of ProGlide was associated with a lower risk of additional surgical treatments (OR 0.52, 95 per cent c.i. 0.34 to 0.80), but a higher risk of endovascular treatments (OR 2.69, 95 per cent c.i. 1.29 to 5.63). In percutaneous transfemoral transcatheter aortic valve replacement procedures, ProGlide has superior safety and efficacy when compared with Prostar; it is associated with fewer major vascular complications and device failures. The vascular complications of ProGlide are more likely to be dealt with using endovascular treatments than surgical treatments.

Impact of Valve Academic Research Consortium 3 (VARC-3) minor access site vascular complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation.

The aim of this study was to investigate the impact of Valve Academic Research Consortium 3 minor access site vascular complications (VCs) in patients who underwent percutaneous transfemoral (TF) transcatheter aortic valve implantation (TAVI). This single-centre retrospective study included consecutive patients who underwent percutaneous TF-TAVI from 2009 to 2021. A propensity score-matched analysis was performed to compare early and long-term clinical results between patients with VC and without VC (nVC). A total of 2161 patients were included, of whom 284 (13.1%) experienced access site VC. Propensity score analysis allowed to match 270 patients from the VC group with 727 patients from the nVC group. In the matched cohorts, the VC group showed longer operative times (63.5 vs 50.0 min, P < 0.001), higher operative and in-hospital mortality (2.6% vs 0.7%, P = 0.022; and 6.3% vs 3.2%, P = 0.040, respectively), longer hospital length of stay (8 vs 7 days, P = 0.001) and higher rates of blood transfusion (20.4% vs 4.3%, P < 0.001) and infectious complications (8.9% vs 3.8%, P = 0.003). Overall survival during follow-up was significantly lower in the VC group (hazard ratio 1.37, 95% CI 1.03-1.82, P = 0.031) with 5-year survival rates being 58.0% (95% CI 49.5-68.0%) and 70.7% (95% CI 66.2-75.5%) for the VC and nVC groups, respectively. This retrospective study observed that minor access site VCs during percutaneous TF-TAVI can be serious events affecting early and long-term outcomes.

Obesity and vascular complication in percutaneous transfemoral transcatheter aortic valve insertion.

Obesity has been associated with an increased risk of vascular complication during percutaneous coronary intervention, but there are no data on the risk of vascular complication during percutaneous transfemoral transcatheter aortic valve insertion (TAVI). We hypothesized there would be a similar increased risk associated with TAVI. We reviewed the records of 1176 patients who received percutaneous transfemoral transcatheter aortic valve insertion from September 2015 to September 2020. All patients received 1) preoperative computed tomoraphy angiography assessment of the abdomen and pelvis to delineate iliofemoral artery anatomy, 2) ultrasound-guided percutaneous femoral arterial access, and 3) pre-closure of the delivery sheath femoral access site. Vascular complication was recorded based on definitions set forth by Valve Academic Research Consortium 3. The median age of patients was 81 years, and 60% were men. The median body mass index (BMI) was 29 kg/m2 (range, 11-67), and 91 (8%) patients had a value ≥40 kg/m2 (i.e., morbid obesity). Delivery sheath size was 14-French in 859 (73%) patients, 16-French in 311 (26%), and 18-French in 6 (1%). Vascular complication occurred in 53 (5%) patients, including 39 (7%) among the first half of procedures and 14 (2%) among the second half (p < 0.001). When stratified by obesity status (BMI < or ≥30 kg/m2 , p < 0.001), the complication rate was 4% in nonobese patients and 5% in obese patients. Multivariable analysis showed no overall association between risk of vascular complication and BMI categories (p = 0.583)BMI continuous values (p = 0.529), or sheath size (p = 0.217). Obesity is not associated with a vascular complication during percutaneous transfemoral transcatheter aortic valve insertion. The operation should not be denied in obese patients.

Totally Percutaneous Transfemoral Transcatheter Aortic Valve Replacement Despite Failure to Deploy a Vascular Closure Device: A Single-Centre Case Series

Transcatheter aortic valve replacement (TAVR) is preferably performed as a completely percutaneous procedure via transfemoral access. Suture-mediated vascular closure devices are deployed prior to sheath insertion (pre-closure). Inability to perform pre-closure may necessitate surgical vascular repair of the femoral artery. Patients at increased risk of vascular surgery complications may benefit from a percutaneous method for achieving access site haemostasis. Stent graft implantation is commonly used for treating access site injury following TAVR. This study assessed the feasibility of a strategy of planned stent graft implantation within the femoral artery for achieving access site haemostasis in patients undergoing transfemoral TAVR and in whom vascular pre-closure was not possible. A prospective institutional TAVR registry was retrospectively analysed and a cohort of patients were identified who were selected for transfemoral valve delivery and in whom pre-closure failed and access site haemostasis was achieved by stent graft implantation. This strategy was used for achieving access site haemostasis in 11 patients (1.5% of 744 patients undergoing transfemoral TAVR). These patients were considered to be at increased risk of vascular surgery complications due to advanced age, frailty, comorbidities, or immobility. Stent graft implantation achieved access site haemostasis in all patients. During follow-up, 30-day mortality was zero, 1-year mortality was 27%, and none of the patients required additional vascular interventions. The preliminary data suggest that planned stent graft implantation within the femoral artery may achieve access site haemostasis and enable a totally percutaneous TAVR procedure, despite failure to perform pre-closure with a suture-based vascular closure device.

Successfully Managed Access-Site Complication Was Not Associated With Worse Outcome After Percutaneous Transfemoral Transcatheter Aortic Valve Implantation: Up-to-Date Insights From the OCEAN-TAVI Registry

BackgroundAccess-site complications during transfemoral transcatheter aortic valve implantation (TF-TAVI) cause serious issues in the future, if unresolved, but the best strategies to manage these complications remains unclear. This study aimed to comprehensively assess access-site complications during percutaneous TF-TAVI in terms of their management. MethodsUsing the prospective, multicentre, observational registry OCEAN (Optimized Transcatheter Valvular Intervention), 1497 patients who underwent percutaneous TF-TAVI between October 2013 and May 2017 were identified. The incidence, predictors, temporal changes, and prognosis of access-site complications along with its treatment strategy and re-intervention rate were evaluated. ResultsAccess-site complications occurred in 105 patients (7.0%) and was predicted with lower body-mass-index (OR, 0.94; 95% CI; 0.89–0.99; p = 0.03) and higher sheath-to-femoral-artery-ratio (OR, 1.12; 95% CI, 1.03–1.24; p < 0.002). The incidence of access-site complications declined over time, irrespective of the increasing number of percutaneous TF-TAVI cases. Access-site complications were treated by conservative therapy (n = 19, 18%), interventional procedures (n = 42, 40%), rescue surgical repair (SR) (n = 10, 10%), and primary SR (n = 34, 32%). The severity of complications differed but the re-intervention rate was similar among 4 groups (p = 0.46). Re-intervention was not needed, except for a case of common femoral artery stenosis/occlusion induced by ProGlide. The need for all SRs decreased annually. Access-site complications were not associated with 30 days- and 1 year-survival rate. ConclusionsThe incidence of access-site complications was not low but has declined annually. Access-site complications are not related to worse outcomes after successful management. Interventional procedure is acceptable as the first-line strategy to treat access-site complications.

Comparison of a Single Versus Double Perclose Technique for Percutaneous Transfemoral Transcatheter Aortic Valve Replacement.

The optimal strategy for arterial closure in percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR) remains under debate. Single-center, prospective, observational study of consecutive patients undergoing TF-TAVR between March 2018 and December 2019 who underwent closure with an upfront single vs double Perclose device. Device success, access-site vascular, and bleeding complications were defined according to the Valvular Academic Research Consortium (VARC)-2 criteria. Inverse-probability of treatment weighting (IPTW) was used to balance baseline characteristics between groups. A total of 241 patients (mean age, 81.4 ± 8.5 years, 47% women) were included, of which 127 underwent an upfront single-Perclose (SP) strategy and 114 underwent an upfront double-Perclose (DP) strategy. Fifty-six percent of patients were treated with a CoreValve (Medtronic). The SP group was less likely to be on dialysis and on aspirin, but were more likely to receive a CoreValve, with larger valve sizes and larger delivery sheaths. Baseline characteristics were well balanced after IPTW adjustment. Device success rate was comparable between groups (96% in the SP group vs 93% in the DP group; P=.39). The SP technique was associated with fewer vascular complications (8.7% in the SP group vs 26.3% in the DP group; P<.01; IPTW relative risk [RR], 0.34; 95% confidence Interval [CI], 0.16-0.71) and bleeding complications (2.4% in the SP group vs 12.3% in the DP group; P<.01; IPTW RR, 0.21; 95% CI, 0.06-0.76) compared with the DP technique. There were no differences in 30-day mortality. An upfront SP technique is equally efficacious and not associated with increased vascular and bleeding complications compared with an upfront DP technique in patients undergoing percutaneous TF-TAVR.

Percutaneous closure of femoral pseudaneurysm after TAVR.

Fully percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR) is currently the standard of the catheter-based treatment of severe aortic stenosis patients. Even though experience, lower delivery catheters profile and improved vascular closure devices performances have resulted in an overall reduction of both vascular and bleeding complications after TAVR, femoral pseudoaneurysm due to incomplete local hemostasis may occur, prolonging the in-hospital length of stay, causing discomfort to the patient and potentially evolving in serious consequences affecting the outcome. We report two successful percutaneous ultrasound-guided closure of both the main and secondary femoral access pseudoaneurysm.

Covered Stents as a First-Line Treatment for Vascular Access Complications During Transfemoral Transcatheter Aortic Valve Implantation: Eight-Year Experience From a Single Center.

We report 8-year experience with vascular access complications (VACs) after percutaneous transfemoral transcatheter aortic valve implantation (TAVI). From January 2010 to January 2018, patients with iliofemoral VAC treated by an intervention following percutaneous transfemoral TAVI were included. Major VAC was defined according to the Valve Academic Research Consortium 2 classification. As first-line strategy, VACs were treated using covered nitinol stents (CS). Among 795 percutaneous transfemoral TAVI, 74 (9.3%) patients (female, 57%; 82 ± 8 years) with VAC treated by CS and/or open repair were included in this study: 59 CS cases and 15 open repair cases. Two CS patients were converted to open repair. Technical success for stent implantation was 97%. The main VAC was a persistent bleeding related to percutaneous closure device failure (72%). Thirty-day mortality in the study cohort was 5.4% (4/74), including 1 VAC-related death. One patient had postoperative lower limb ischemia successfully treated by open repair. No amputation, new-onset claudication or in-stent occlusion was recorded. Endovascular intervention using self-expandable nitinol covered stent is safe and effective as a first-line strategy for the treatment of VAC in percutaneous transfemoral TAVI. However, open repair is needed in case of unfeasibility or failure of endovascular therapy.

Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement

ObjectivesTo 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). BackgroundLimited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14–16 French (F) sheaths. MethodsWe 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. ResultsThe final sample consisted of 303 percutaneous TF-TAVRs. Median age was 80 years, 51% were male, 86% Caucasian, 33% had diabetes mellitus (DM) and mean STS score was 5.8 ± 3.8%. Baseline characteristics were similar in patients with vs. without VCs, other than coronary artery disease (CAD) (69% vs. 54%, respectively; p = 0.029) and DM (21% vs. 36%, respectively; p = 0.02). There were 65 (21%) vascular complications: 19 major VCs [6.3%], 29 minor [VCs 9.6%] and 17 PCDFs [5.6%]. Overall, 30-day mortality was low (2.6%). Major VCs were associated with higher mortality (42% vs. 0%, p < 0.0001) while minor VCs (3% vs. 0%, mortality p = 0.99) and PCDFs (3% vs. 0% mortality, p = 0.99) were not. PCDFs were associated with a longer median LOS (4 vs. 3 days, p = 0.02). The independent predictors of major VCs were pelvic vessel tortuosity (OR 3.1; 95% CI 1.1–9.2) and presence of CAD (OR 8.2; 95% CI 1.8–37). Female gender showed a strong trend toward increased risk (OR 3.4; CI 0.84–14; p = 0.086). There were no independent predictors of PCDF. ConclusionContemporary percutaneous TF-TAVR is associated with a low risk of mortality, major VCs and PCDFs. Major VCs confer increased mortality and PCDFs prolong LOS. Pelvic vessel tortuosity and a history of CAD predict major VCs; there were no predictors of PCDFs. These results provide a contemporary update on the incidence and implications of these important vascular complications in the current era of percutaneous TF-TAVR using 14-16F vascular sheaths.

Risk Factors for Closure Failure following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation

The percutaneous access site of transfemoral transcatheter aortic valve implantation (TAVI) procedures is commonly closed using a preclosure technique with suture-type closure devices. We sought to evaluate the predictors and outcomes of percutaneous closure device (PCD) failure during transfemoral TAVI. This single-center retrospective analysis included 184 patients who underwent transfemoral TAVI using 2 ProGlide sutures for severe aortic stenosis between July 2011 and September 2018. PCD failure was observed in 11.4%. The causes of PCD failure included 5 cases of insufficient hemostasis, 13 cases of arterial stenosis or occlusion, and 3 cases of dissection. Closure failures were managed by surgical repair in 10 patients and endovascular treatment in 11 patients. In a multivariate binary logistic model, a minimum lumen diameter of the common femoral artery (CFA) (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.15-0.83, P=0.017) and left femoral access (OR 2.89, 95% CI 1.01-8.30, P=0.048) was identified as a predictor of PCD failure. PCD failure was not associated with increased mortality (0% vs. 2.5%, P=1.000) or a major adverse cardiovascular event (MACE; 4.8% vs. 4.3%, P=1.000) at 30days. PCD failures were not uncommon in patients undergoing percutaneous transfemoral TAVI. Small CFA diameter and left femoral access are predictors of PCD failure. However, PCD failures were not associated with increased mortality or MACE.

The ARAHKEY technique: A novel method for the management of access site bleeding during percutaneous transfemoral transcatheter aortic valve replacement.

This retrospective study assessed the safety and efficacy of the ARAHKEY (ARterial sealing with Additional Hemostatic device Kissing with Extravascular and suture-based device deeplY) technique during transcatheter aortic valve replacement (TAVR). Access site complications are still a major issue to be solved during TAVR using a large caliber sheath. From February 2014 to June 2019, a total of 302 patients underwent TAVR in our hospital. Twenty-five patients (10.2% of patients who underwent percutaneous transfemoral TAVR [n = 246]) were treated using the ARAHKEY technique, which is the additional use of Exoseal for the common femoral artery puncture site when hemostasis was not achieved with ProGlide alone. Complete hemostasis was achieved in all patients (100%). The mean procedural time for hemostasis was 9.8 ± 4.5 min. No complications, including recurrent bleeding, infection, and late acquired hematoma, were observed in this study cohort. The ARAHKEY technique is a safe method and should be considered as a secondary option when hemostasis is not achieved with ProGlide during TAVR.

Computed Tomographic Angiography-Derived Risk Factors for Vascular Complications in Percutaneous Transfemoral Transcatheter Aortic Valve Implantation

Transfemoral aortic valve implantation (TAVI) has become a viable alternative to surgical valve implantation, particularly for higher risk patients; however, vascular complications (VCs) remain a concern in transfemoral TAVI. We aimed to determine clinical and computed tomographic angiography-derived risk factors associated with Valve Academic Research Consortium (VARC)-2 criteria VCs in patients who underwent TAVI. From 2011 to 2017, 481 patients underwent percutaneous transfemoral TAVI at the Minneapolis Heart Institute and were screened for procedural and postprocedural access-related VC according to VARC-2 criteria. Clinical and clinical and computed tomographic angiography-derived data were collected to establish risk factors for VC. A total of 99 (21%) patients had VARC-2 VCs. Closure device failure (CDF) occurred in 56 of 99 (57%), minor VCs in 37 of 99 (37%), and major VCs occurred in 6 of 99 (6%). Access site-related VCs were preceded by CDF in 18 of 43 (42%) patients and the risk of major/minor VCs was 14 times greater in patients who experienced closure complications. The incidence of CDF was higher in common femoral artery (CFA) access sites with circumferential vessel wall calcification of more than 90° (p = 0.02) and when skin-surface to CFA access-site distance at an optimal access angle of 45° exceeded 80 mm (p = 0.03). In conclusion, both the degree of circumferential CFA access site calcification and distance to skin surface at an optimal access angle may improve risk stratification of access planning in patients who underwent percutaneous transfemoral TAVI.

Diabetes mellitus is not associated with worse vascular outcome following percutaneous transfemoral transcatheter aortic valve implantation

Background: Transcatheter aortic valve implantation (TAVI) is an alternative to open surgical aortic valve replacement and the impact of diabetes on vascular outcomes is worth of investigation. The aim of our study was to determine if diabetic patients had distinct pre-operative characteristics compared to non-diabetics and to evaluate the impact of the disease on vascular outcomes.Methods: Four hundred consecutive patients who underwent TAVI with percutaneous transfemoral access were retrospectively included. Vascular outcomes were classified according to the Valve Academic Research Consortium 2 classification.Results: Seventy-eight (19.5%) patients were diabetics. Compared to non-diabetics, diabetic patients were younger and had significantly higher body mass index (29.7+/– 0.7 kg/m2 vs 26.8+/– 0.3, p < .0001), higher proportion of associated dyslipidemia (34.6% vs 11.5%, p < .0001) and arterial hypertension (60% vs 38.2%, p = .0009). Anatomical characteristics of the vascular access and procedural characteristics did not differ among the groups. No significant difference was observed in the incidence of major and minor vascular complications and 30-day post-operative mortality between diabetic and non-diabetic patients (2.6% vs 1.9%, p = .6916).Conclusion: Diabetes is not associated with worse vascular outcome following TAVI suggesting that the vascular access can be managed safely in these patients.

Ultrasound Guided Technique for Percutaneous Transfemoral Transcatheter Aortic Valve Implantation

Aim/objective: The aim of this study was to determine the outcomes of ultrasound-guided technique for patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI) to prevent vascular complications. Method: We report a single centre analysis of 154 patients of a prospectively collected cohort between who underwent transfemoral TAVI using the balloon-expandable Edwards SAPIEN 3 transcatheter heart valve. Patients were divided into two groups (non ultrasound-guided puncture group who underwent TAVI n = 86 compared to those patients who underwent ultrasound-guided puncture n = 68.) The incidence of major vascular complications as defined by The Valve Academic Research Consortium - 2 Criteria (VARC2 criteria) and bleeding complications as defined by the Bleeding Academic Research Consortium (BARC) were used as outcome measures. Results: The incidence of major access site related complications were low and were numerically reduced with ultrasound guided puncture (4.65% vs 0.0%; p = 0.135.) BARC Bleeding criteria greater or equal to 3 was similar between groups (2.33% vs 1.47%; p = NS). Conclusion: This study demonstrates a numerical trend to improved outcomes following the use of ultrasound-guided percutaneous transfemoral puncture for TAVI. This technique has been shown to prevent vascular complications as defined by VARC2 criteria.

The novel echo-guided ProGlide technique during percutaneous transfemoral transcatheter aortic valve implantation.

The aim of this study was to assess clinical benefit of the Echo-guided ProGlide technique in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI). The efficacy of the Echo-guided ProGlide technique during percutaneous TF-TAVI was not previously clarified. A total of 121 consecutive patients who underwent percutaneous TF-TAVI at our institution between February 2014 and July 2017 were enrolled in this study. According to the introduction of this novel technique in March 2016, patients were divided into two groups (echo-guided group who underwent TAVI from March 2016 to July 2017, n = 63; not echo-guided group who underwent TAVI from February 2014 to February 2016, n = 58). The incidence of major vascular complications, defined per the Valve Academic Research Consortium-2 criteria, and ProGlide complications including acute femoral artery stenosis or occlusion and bleeding requiring any intervention. The incidence of major vascular complication and ProGlide complication were significantly lower in the echo-guided group than in not echo-guided group (1.6% vs 17.2%, P < 0.002; 1.6% vs 15.5%, P = 0.003; respectively). Use of the Echo-guided ProGlide technique was independently associated with prevention of ProGlide complications (odds ratio, 0.11; 95% confidential interval, 0.01-0.76; P = 0.03). This novel Echo-guided ProGlide technique was associated with a lower rate of major vascular complications, particularly ProGlide complications during percutaneous TF-TAVI.

Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation

BackgroundManagement of femoral access site is an important issue in transfemoral transcatheter aortic valve implantation (TAVI) and crucial for acute and long-term outcome. Data on vascular closure devices in this setting are limited. We evaluated safety and efficacy of the Prostar XL compared to the ProGlide suture-based vascular closure device. Methods and resultsWe enrolled 585 patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TAVI). Outcomes were defined according to Valve academic research consortium (VARC)-2 criteria. In 237 (40.5%) patients femoral access site closure was performed using the Prostar and in 348 patients (59.6%) using the ProGlide vascular closure device. There was no significant difference in patient baseline characteristics including single and dual antiplatelet therapies. Sheath outer diameter was significantly larger in the ProGlide compared with the Prostar group (7.7±1.5 vs. 7.9±0.5mm; p=0.001). Closure device failure according to VARC-2 criteria was significantly more frequent with the Prostar versus ProGlide device (19% vs. 4.6%; p<0.01). Need for surgical repair (11.8% vs. 0%, p<0.01), major (12.2% vs. 2.3%, p<0.01) and minor (17.3% vs. 5.7%, p<0.01) vascular complications and bleeding complications (5.5% vs. 2.0%, p=0.02) occurred significantly more often with the Prostar device compared with the ProGlide system. In addition, in-hospital mortality was higher with Prostar compared with ProGlide (5.9% vs. 2.0%; p=0.01). ConclusionFemoral access site closure with the ProGlide device compared with the Prostar device in transfemoral aortic valve implantation was associated with significantly lower rates of closure device failure, minor and major bleedings and a significantly lower in-hospital mortality.Clinical Trial Registration:clinicaltrials.govNCT02162069.

Impact of Mean Platelet Volume on Combined Safety Endpoint and Vascular and Bleeding Complications following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation

Background. Vascular and bleeding complications remain important complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI). Platelets play an important role in bleeding events. Mean platelet volume (MPV) is an indicator of platelet activation. The objective of this study was to assess whether low MPV is an indicator of major vascular and bleeding complications following TF-TAVI. Methods. A retrospective cohort study of 330 subjects undergoing TF-TAVI implantation was performed. The primary study endpoint was the occurrence of combined safety endpoint (CSEP); secondary endpoints included major vascular complications and life-threatening bleeding. Endpoints were defined according to Valve Academic Research Consortium 2. Results. The CSEP at 30 days was reached in 30.9%; major vascular complications were observed in 14.9% while life-threatening bleeding occurred in 20.6%. Logistic Euroscore and MPV were independent predictors of CSEP. Predictors of vascular complications were female sex, previous myocardial infarction, red blood cell distribution width (RDW), and MPV while predictors of life-threatening bleeding were peripheral arterial disease, RDW, and MPV. Conclusion. A low baseline MPV was shown for the first time to be a significant predictor of CSEP, major vascular complications, and life-threatening bleeding following TF-TAVI.

A simple percutaneous technique for hemostasis and closure after transcatheter aortic valve implantation

Access closure is a key element to successful retrograde percutaneous transfemoral transcatheter aortic valve implantation. It requires large-bore femoral arterial access (18Fr-28Fr) which most operators manage with surgical access and closure under general anesthesia. We report a case example of how, using our center's peripheral interventional experience, we have developed a simple five step technique to achieve hemostasis percutaneously.