Percutaneous Transcatheter Aortic Valve Research Articles

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.

Impact of Transcatheter Aortic Valve Implantation on Kidney Function.

BackgroundChronic kidney disease (CKD) is frequently present in patients with aortic valve disease. Decreased kidney perfusion as a consequence of reduced cardiac output may contribute to renal dysfunction in this setting.ObjectiveGiven the potential reversibility of kidney hypoperfusion after valve repair, this study aimed to analyze the impact of percutaneous transcatheter aortic valve implantation (TAVI) on kidney function.MethodsWe performed a retrospective analysis of 233 consecutive patients who underwent TAVI in a single center between November 2008 and May 2016. We assessed three groups according to their baseline estimated glomerular filtration rate (eGFR) (mL/min/1.73 m2): Group 1 with eGFR ≥ 60; Group 2 with 30 ≤ eGFR < 60; and Group 3 with eGFR < 30. We analyzed the eGFR one month and one year after TAVI in these three groups, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula to calculate it.ResultsPatients from Group 1 had a progressive decline in eGFR one year after the TAVI procedure (p < 0.001 vs. pre-TAVI). In Group 2 patients, the mean eGFR increased one month after TAVI and continued to grow after one year (p = 0.001 vs. pre-TAVI). The same occurred in Group 3, with the mean eGFR increasing from 24.4 ± 5.1 mL/min/1.73 m2 before TAVI to 38.4 ± 18.8 mL/min/1.73 m2 one year after TAVI (p = 0.012).ConclusionsFor patients with moderate-to-severe CKD, kidney function improved one year after the TAVI procedure. This outcome is probably due to better kidney perfusion post-procedure. We believe that when evaluating patients that might need TAVI, this ‘reversibility of CKD effect’ should be considered.

Plug-based closure in completely percutaneous right-sided transaxillary transcatheter aortic valve implantation.

Plug-based closure in completely percutaneous right-sided transaxillary transcatheter aortic valve implantation.

Comparison of Complication and Success Rates of ProGlide Closure Device in Patients Undergoing TAVI and Endovascular Aneurysm Repair.

Introduction Usage of the Perclose ProGlide® (PP: Abbott Laboratories, Chicago, IL, USA) closure device is becoming increasingly prevalent during percutaneous endovascular aortic repair (EVAR) and transcatheter aortic valve implantation (TAVI). The respective conditions treated via these procedures, abdominal aortic aneurysm and aortic valve stenosis, share risk factors but are two different physiopathological problems. Aim Our aim was to compare the complication and success rates of PP closure device use in patients undergoing EVAR and TAVI. Materials and Methods A total of 74 patients, including 58 undergoing TAVI and 16 undergoing EVAR, were analysed in our study. Results Of the TAVI patients treated using the PP closure device, two (3.4%) had access to site-related bleeding complications and two (3.4%) experienced device failure. Of the EVAR patients who received the PP closure device, three (18.8%) had bleeding complications and three (18.8%) experienced device failure. Conclusion Due to the underlying diffuse aortic wall pathology, the success rate of PP closure device use was lower and the complication rate of PP closure device was higher in the EVAR group versus the TAVI group.

Antiplatelet Treatment for Catheter-Based Interventions in High-Risk Patients: Current Guidelines and Expert Opinion.

Catheter-based interventions have revolutionized treatment of both coronary artery disease and aortic valve disease. Yet, these procedures are accompanied by thromboembolic and bleeding complications. Antiplatelet agents and anticoagulants with tolerable risk of bleeding complications are required to protect from recurrent thromboembolic events. Although guidelines for antithrombotic treatment in patients undergoing percutaneous coronary intervention (PCI) and transcatheter aortic valve replacement (TAVR) are available, scarce evidence exists regarding therapeutic recommendations for patients at high risk for thromboembolic events or major bleeding. The choice of optimal antiplatelet therapy after PCI in patients with complex coronary artery disease and concomitant atrial fibrillation often poses a clinical challenge. The antiplatelet therapy in patients undergoing TAVR is so far based mostly on expert consensus. The present review addresses state-of-the-art antithrombotic therapy, particularly focusing on patients at high risk of thromboembolic and bleeding events, and aims to provide recommendations for clinical practice.

Use of Bivalirudin for Anticoagulation in Interventional Cardiovascular Procedures

Anticoagulation is imperative to reduce the incidence of thrombotic complications in patients undergoing percutaneous interventional cardiovascular procedures; however, this is at the expense of increased risk of bleeding. The optimal anticoagulation strategy for these procedures remains unclear. Unfractionated heparin is the most commonly used anticoagulant during interventional procedures, but has several limitations, such as relatively high incidence of bleeding events, occurrence of heparin-induced thrombocytopenia, and a paradoxical thrombotic effect. Contemporary studies have demonstrated that bivalirudin decreases the occurrence of bleeding complications, but potentially increases the risk of acute stent thrombosis. This review discusses the pharmacology of bivalirudin and its current clinical application in patients undergoing percutaneous coronary intervention and transcatheter aortic valve replacement procedures.

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.

Percutaneous transcatheter aortic valve replacement induces femoral artery shrinkage: angiographic evidence and predictors for a new side effect.

We sought to investigate the possible impact of transaortic valve replacement (TAVR) on common femoral artery (CFA) integrity as assessed by angiography. CFA represents the most adopted access for TAVR but various degrees of vascular damage may be induced by the procedure. Patients underwent percutaneous transfemoral TAVR who had both pre- and post-TAVR access-site angiography were retrospectively selected. Clinical and procedural data (including technique and complications) were prospectively recorded into a structured TAVR database. Pre-TAVR and post-TAVR angiograms were analyzed using a quantitative angiographic analysis software to assess reference diameters, minimum luminal diameter (MLD), and percentage of diameter stenosis (DS). A total of 124 patients entered the study (mean age: 85 years, mean Euroscore II: 10%). ProStar (13.5%) and double ProGlide (82.2%) preclosure were the main hemostatic techniques. CFA exhibited a significant shrinkage with TAVR as assessed by significant MLD reduction (5.6 mm after TAVR vs. 6.8 mm before, P < .001) and DS increase (30.3% after vs. 17.0%, P < .001). Such differences remained statistically significant after exclusion of 18 patients (14.2%) who had (minor or major) vascular complications. At multivariable analysis, pre-TAVR DS (P = .03) and history of peripheral arterial disease (P = .01), were significantly associated with vascular complications. Percutaneous TAVR induces an angiographically detectable CFA lumen reduction. Such findings call for further studies assessing clinical impact of this phenomenon and open the door for further refinements of the TAVR access management aimed at preserving vessel integrity.

PP48 - Acute kidney injury (AKI) as predictor of mortality in patients after percutaneous transcatheter aortic valve implantation (TAVI)

PP48 - Acute kidney injury (AKI) as predictor of mortality in patients after percutaneous transcatheter aortic valve implantation (TAVI)

An In Vitro Feasibility Study of the Influence of Configurations and Leaflet Thickness on the Hydrodynamics of Deformed Transcatheter Aortic Valve.

Clinically, the percutaneous transcatheter aortic valve (TAV) has been reported to be deformed in a noncircular configuration after its implant. The deformation is universal and various, and it leads to serious leakage and durability problems. Even in the same deformation, the leaflets made in different tissue thicknesses may cause different hydrodynamic performances. Simulating the left heart cardiac conditions by a pulse duplicator system, the present study investigated the effects of the aortic annulus deformation and the leaflet tissue thickness on the hydrodynamics of the TAV. Three 22 mm self-expanding TAV samples were fabricated with three different leaflet thicknesses (0.25, 0.4, 0.55 mm). Every sample was successively deformed to be elliptical, triangular, and undersized circular shapes. The hydrodynamics of the TAV were assessed through a quasi-physiological artery pulsatile flow duplicator system. The transvalvular pressure difference, effective orifice area, and regurgitation flow were determined. High-speed video recordings were taken to investigate the leaflet kinematics. The results showed that the triangular deformation produced the poorest valve function while the elliptical deformation led to the slightest difference from the nominal. With increasing leaflet thickness, the effect of configuration deformation on the regurgitation increased. The thinner leaflets were better than the thicker ones in adapting to the deformation but had a higher risk of deterioration.

Prevention of Contrast-Induced Acute Kidney Injury by Furosemide With Matched Hydration in Patients Undergoing Interventional Procedures: A Systematic Review and Meta-Analysis of Randomized Trials

ObjectivesThe objective of this meta-analysis of randomized trials was to evaluate if the administration of furosemide with matched hydration using the RenalGuard System reduces contrast-induced acute kidney injury (CI-AKI) in patients undergoing interventional procedures. BackgroundCI-AKI is a serious complication following angiographic procedures and a powerful predictor of unfavorable early and long-term outcomes. MethodsOnline databases were searched up to October 1, 2016, for randomized controlled trials. The primary outcome was the incidence of CI-AKI, and the secondary outcomes were need for renal replacement therapy, mortality, stroke, and adverse events. ResultsA total of four trials (n = 698) published between 2011 and 2016 were included in the analysis and included patients undergoing percutaneous coronary procedures and transcatheter aortic valve replacement. RenalGuard therapy was associated with a lower incidence of CI-AKI compared with control treatment (27 of 348 [7.76%] patients vs. 75 of 350 [21.43%] patients; odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.19 to 0.50; I2 = 4%; p < 0.00001) and with a lower need for renal replacement therapy (2 of 346 [0.58%] patients vs. 12 of 348 [3.45%] patients; OR: 0.19; 95% CI: 0.05 to 0.76; I2 = 0%; p = 0.02). No major adverse events occurred in patients undergoing RenalGuard therapy. ConclusionsThe main finding of this meta-analysis is that furosemide with matched hydration by the RenalGuard System may reduce the incidence of CI-AKI in high-risk patients undergoing percutaneous coronary intervention or transcatheter aortic valve replacement. However, further independent high-quality randomized trials should elucidate the effectiveness and safety of this prophylactic intervention in interventional cardiology.

Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients

ObjectivesTranscatheter Aortic Valve Implantation (TAVI) can be performed via the transaxillary approach, but data about complications and procedural outcome is limited. IntroductionTAVI is an established treatment option for patients at high risk for conventional aortic valve replacement. Nowadays, the transfemoral approach is the most commonly used access for TAVI. Nevertheless, the transfemoral access is not suitable in many patients necessitating alternative approaches. MethodsWe analyzed the outcome of 100 consecutive cases receiving percutaneous transaxillary TAVI at two different hospitals. Data were retrospectively analyzed by means of procedural, hemodynamic and clinical outcome. In addition, 1st versus 2nd generation devices were analyzed. ResultsMean age was 78.2±2.1years and the logEuroSCORE I was 24.6±13.9%. Transaxillary TAVI was performed in 85% via the left and in 15% via the right axillary artery. Device success was achieved in 95%. In general, there was a clear learning curve with this approach. No patient experienced a major and 11% a minor access site complication. There was one procedural death (annular rupture) and one peri-procedural TIA. 23% of the patients received a new pacemaker. At discharge, effective orifice area was 1.94±0.16cm2 and the mean aortic gradient was 6.8±2.1mmHg. Moderate aortic regurgitation/paravalvular leakage was documented in two patients. Mortality rates at 30days and one year were 6% and 14.8%. Last but not least, 2nd generation devices showed improved procedural outcomes. ConclusionsThe percutaneous transaxillary access for TAVI is technically feasible and safe thereby yielding excellent clinical results. Condensed abstractWe investigated In 100 consecutive patients undergoing percutaneous transaxillary transcatheter aortic valve implantation thereby demonstrating that this approach is technically feasible and safe with acceptable numbers of minor vascular complications.

Primary Mitral Valve Regurgitation Outcome in Patients With Severe Aortic Stenosis 1 Year After Transcatheter Aortic Valve Implantation: Echocardiographic Evaluation.

BackgroundMitral valve regurgitation (MR), present in up to 74% of the patients with severe aortic stenosis (AS), can be a negative prognostic factor when moderate or severe. The outcome of MR after percutaneous transcatheter aortic valve implantation (TAVI) and predictors associated with that outcome have not been well established in the literature.ObjectiveTo assess the outcome of primary MR in patients submitted to TAVI and to identify associated factors.MethodsObservational study of patients with symptomatic severe AS submitted to TAVI from January 2009 to April 2015 at two specialized centers. Echocardiographic outcome was assessed with data collected before and 1 year after TAVI.ResultsOf the 91 patients with MR submitted to TAVI and followed up for at least 12 months, 67 (73.6%) had minimum/mild MR before the procedure and 24 (26.4%) had moderate/severe MR. Of those with minimum/mild MR, 62 (92.5%) had no change in the MR grade (p < 0.001), while 5 (7.5%) showed worsening. Of those with moderate/severe MR, 8 (33.3%) maintained the same grade and 16 (66.7%) improved it (p = 0.076). Patients with moderate/severe MR who improved MR grade had lower EuroSCORE II (p = 0.023) and STS morbidity (p = 0.027) scores, as compared to those who maintained the MR grade.ConclusionMR grades change after TAVI. This study suggests a trend towards improvement in moderate/severe MR after TAVI, which was associated with lower preoperative risk scores.

Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation

BackgroundTranscaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. ObjectivesThe authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access. MethodsA total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%. ResultsTranscaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge. ConclusionsTranscaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824)

TCT-697 Comparison of Outcomes of Transcatheter Aortic Valve Replacement plus Percutaneous Coronary Intervention versus Transcatheter Aortic Valve Replacement Alone in the United States

Transcatheter aortic valve replacement (TAVR) in combination with percutaneous coronary intervention (PCI) has emerged as a less invasive and feasible therapeutic option for this high surgical risk patient population with AS and CAD. The aim of this study is to determine the outcomes of TAVR when

Comparison of Outcomes of Transcatheter Aortic Valve Replacement Plus Percutaneous Coronary Intervention Versus Transcatheter Aortic Valve Replacement Alone in the United States

Transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) has emerged as a less-invasive therapeutic option for high surgical risk patients with aortic stenosis and coronary artery disease. The aim of this study was to determine the outcomes of TAVR when performed with PCI during the same hospitalization. We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. A total of 22,344 TAVRs were performed between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR+ PCI group). Among the TAVR+ PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel, and 1.6% had 3-vessel PCI. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). TAVR+ PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%) and complications: vascular injury requiring surgery (8.2% vs 4.2%), cardiac (25.4% vs 18.6%), respiratory (24.6% vs 16.1%), and infectious (10.7% vs 3.3%), p <0.001% for all, compared with the TAVR group. The mean length of hospital stay and cost of hospitalization were also significantly higher in the TAVR+ PCI group. The propensity score-matched analysis yielded similar results. In conclusion, performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications, and cost compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR.

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.

Percutaneous transcatheter aortic valve implantation for degenerated surgical bioprostheses: the first case series in Asia with one-year follow-up.

Percutaneous transcatheter aortic valve implantation (TAVI) has become an established therapy for inoperable and high-surgical-risk patients with severe aortic stenosis. Although TAVI in patients with degenerated surgical aortic bioprostheses (i.e. valve-in-valve TAVI) is increasingly reported in Western studies, such data is lacking in Asian patients. We describe the initial experience of valve-in-valve TAVI in Asia. Eight patients who underwent valve-in-valve TAVI due to degenerated aortic bioprostheses were enrolled. The mechanism of bioprosthetic valve failure was stenotic, regurgitation or mixed. All procedures were performed via transfemoral arterial access, using the self-expanding CoreValve prosthesis or balloon-expandable SAPIEN XT prosthesis. The mean age of the patients was 71.6 ± 13.2 years and five were male. Mean duration to surgical bioprosthesis degeneration was 10.2 ± 4.1 years. Valve-in-valve TAVI was successfully performed in all patients. CoreValve and SAPIEN XT prostheses were used in six and two patients, respectively. There were no deaths, strokes or permanent pacemaker requirement at 30 days, with one noncardiac mortality at one year. All patients experienced New York Heart Association functional class improvement. Post-procedure mean pressure gradients were 20 ± 11 mmHg and 22 ± 8 mmHg at 30 days and one year, respectively. Residual aortic regurgitation (AR) of more than mild severity occurred in one patient at 30 days. At one year, only one patient had mild residual AR. In our experience of valve-in-valve TAVI, procedural success was achieved in all patients without adverse events at 30 days. Good clinical and haemodynamic outcomes were sustained at one year.

Comparison of 1-Year Outcome in Patients With Severe Aorta Stenosis Treated Conservatively or by Aortic Valve Replacement or by Percutaneous Transcatheter Aortic Valve Implantation (Data from a Multicenter Spanish Registry)

The factors that influence decision making in severe aortic stenosis (AS) are unknown. Our aim was to assess, in patients with severe AS, the determinants of management and prognosis in a multicenter registry that enrolled all consecutive adults with severe AS during a 1-month period. One-year follow-up was obtained in all patients and included vital status and aortic valve intervention (aortic valve replacement [AVR] and transcatheter aortic valve implantation [TAVI]). A total of 726 patients were included, mean age was 77.3 ± 10.6 years, and 377 were women (51.8%). The most common management was conservative therapy in 468 (64.5%) followed by AVR in 199 (27.4%) and TAVI in 59 (8.1%). The strongest association with aortic valve intervention was patient management in a tertiary hospital with cardiac surgery (odds ratio 2.7, 95% confidence interval 1.8 to 4.1, p <0.001). The 2 main reasons to choose conservative management were the absence of significant symptoms (136% to 29.1%) and the presence of co-morbidity (128% to 27.4%). During 1-year follow-up, 132 patients died (18.2%). The main causes of death were heart failure (60% to 45.5%) and noncardiac diseases (46% to 34.9%). One-year survival for patients treated conservatively, with TAVI, and with AVR was 76.3%, 94.9%, and 92.5%, respectively, p <0.001. One-year survival of patients treated conservatively in the absence of significant symptoms was 97.1%. In conclusion, most patients with severe AS are treated conservatively. The outcome in asymptomatic patients managed conservatively was acceptable. Management in tertiary hospitals is associated with valve intervention. One-year survival was similar with both interventional strategies.

The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement

The objective of this study was to describe and evaluate the adjunctive technique of Angio-Seal (AS) use to augment the dual Perclose ProGlide (PP) in achieving haemostasis in patients undergoing transfemoral percutaneous transcatheter aortic valve replacement (TAVR). All patients who underwent TAVR from May 2007 to January 2015 via a planned transfemoral percutaneous approach with a dual PP pre-close strategy were retrospectively analysed. This cohort was divided into two groups: dual PP versus dual PP with adjunctive AS (PP+AS) use based on the specific status of intraprocedural haemostasis. The baseline and procedural characteristics and in-hospital outcomes were prospectively collected and retrospectively compared. Overall, a total of 387 consecutive patients (55% male, mean age 83 years) with dual PP (n=179) vs. dual PP+AS (n=208) were evaluated. There were no statistically significant differences between the dual PP vs. dual PP+AS groups with regard to the in-hospital Valve Academic Research Consortium-2 (VARC-2) primary endpoints of major vascular complications (8.0% vs. 6.6%, p=0.592), minor vascular complications (18.4% vs. 13.7%, p=0.218), life-threatening or disabling bleeding (5.1% vs. 3.0%, p=0.291), major bleeding (1.7% vs. 1.5%, p=1.000), and minor bleeding (14.4% vs. 10.6%, p=0.271). The adjunctive Angio-Seal technique to augment the dual PP pre-close strategy for patients undergoing percutaneous femoral closure following TAVR is feasible and safe and may be considered as a bail-out or an alternative strategy when the dual PP closure technique fails to obtain complete haemostasis.