Risk Of Major Vascular Complications Research Articles

Vascular complications and outcomes following transcatheter aortic valve replacement in patients on chronic steroid therapy: a meta-analysis.

Chronic steroid (CS) therapy was reportedly linked to increased vascular complications following percutaneous coronary intervention. However, its association with vascular complications after transcatheter aortic valve replacement (TAVR) remained uncertain, with conflicting results being reported. The authors aimed to compare the rate of vascular complications and outcomes between patients with and without CS use after TAVR. The authors conducted a comprehensive literature search in PubMed, Embase, and Cochrane databases from their inception until 18th April 2022 for relevant studies. Endpoints were described according to Valve Academic Research Consortium-2 definitions. Effect sizes were pooled using DerSimonian and Laird random-effects model as risk ratio (RR) with 95% CI. Five studies with 6136 patients undergoing TAVR were included in the analysis. The included studies were published between 2015 and 2022. The mean ages of patients in both study groups were similar, with the CS group averaging 80 years and the nonsteroid group averaging 82 years. Notably, a higher proportion of patients in the CS group were female (56%) compared to the nonsteroid group (54%). CS use was associated with a significantly higher risk of major vascular complications (12.5 vs. 6.7%, RR 2.32, 95% CI: 1.73-3.11, P <0.001), major bleeding (16.8 vs. 13.1%, RR 1.61, 95% CI: 1.27-2.05, P <0.001), and aortic annulus rupture (2.3 vs. 0.6%, RR 4.66, 95% CI: 1.67-13.01, P <0.001). There was no significant difference in terms of minor vascular complications (RR 1.43, 95% CI: 1.00-2.04, P =0.05), in-hospital mortality (2.3 vs. 1.4%, RR 1.86, 95% CI: 0.74-4.70, P =0.19), and 30-day mortality (2.9 vs. 3.1%, RR 1.14, 95% CI: 0.53-2.46, P =0.74) between both groups. Our study showed that CS therapy is associated with increased major vascular complications, major bleeding, and annulus rupture following TAVR. Further large multicenter studies or randomized controlled trials are warranted to validate these findings.

Ultrasound-guided deployment of ProGlide™ device in transfemoral transcatheter aortic valve implantation and risk reduction of vascular complications: A propensity-matched cohort study.

ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. We collected relevant clinical data of patients undergoing TAVI in a large volume centre. main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. Five hundred and seventeen patients undergoing TF-TAVI were included. In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.

Chronic systemic glucocorticoid therapy is associated with increased risk of major vascular complications and cardiac tamponade after transcatheter aortic valve implantation: a systematic review and meta-analysis.

TAVI-related complications, such as conduction disturbances, vascular complications or death may be related to increased inflammatory response. The aim of this study was to elucidate the efficacy and safety of the systemic glucocorticoid therapy regarding the adverse events after TAVI deployment. We conducted a systemic search of PubMed, a reference list of relevant articles, and Medline. The main efficacy outcomes of interest were all-cause death, cardiac and non-cardiac death, permanent pacemaker implantation (PPM), new left bundle branch block (LBBB), stroke, and myocardial infarction (MI). Safety endpoints were major vascular complications, major bleeding events, and cardiac tamponade. A total of 7 studies including data from 3439 patients with a median follow-up was 30 days. Systemic glucocorticoid compared to the control group were associated with an increased risk of non-cardiac death (Relative Risk [RR] 5.90 95%CI [2.95; 11.80], P<0.001) major vascular complications (RR 1.78, 95%CI [1.22 - 2.61], P=0.003) and cardiac tamponade (RR 3.42, 95%CI [1.69 - 6.92], P<0.001). However, there were no differences in all-cause death, cardiac death, new LBBB, stroke, MI, or major bleeding events (all P values >0.05). Glucocorticoid therapy before the TAVI procedure was associated with an increase in non-cardiac death, major vascular events and cardiac tamponade. There were no differences in the risk of all-cause death, cardiac death, PPM or LBBB, stroke, or MI.

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.

PO-05-068 MAJOR VASCULAR COMPLICATIONS IN A LARGE COHORT OF PATIENTS UNDERGOING CATHETER ABLATION FOR VPB/VT IN A HIGH-VOLUME, TERTIARY EP CENTER

Catheter ablation is an established treatment method both in patients with idiopathic premature ventricular complexes (PVC) or ventricular tachycardia (VT) and in structural heart disease (SHD) VT. Major vascular complications (MVCs) are the most frequent in these populations. A retrospective study investigating the incidence of MVCs in large-volume, specialized VT center and analyzing their predictors. We included PVC/VT patients who had their first ablation procedure between August 2006 - December 2020. The procedures were performed under conscious sedation except for patients who were on mechanical ventilation because of hemodynamical or electrical instabilit. Activation mapping supported by an electroanatomic mapping system was used in idiopathic cases. In SHD, substrate mapping using an electroanatomic mapping system and pacemapping was employed as a prerequisite for complete substrate modification during spontaneous rhythm or pacing. Activation and entrainment mapping for well-tolerated VTs were rarely used. The goal of ablation was to abolish all inducible VTs. A specific institutional tracking system for complications of invasive procedures was used to collect all periprocedural complications that were subsequently adjudicated. MVCs were defined as those that result in permanent injury or death, require intervention or treatment, prolong hospitalization (>48 hrs) or require new hospitalization. Idiopathic PVC/VT ablation was performed in 656 pts (males: 50%, age: 51 ± 17 years, re-ablations: 15%). SHD VT was ablated in 1637 pts (males: 88%, age: 63 ± 13 years, re-ablations: 30%, ischemic cardiomyopathy: 65%, left ventricular ejection fraction: 34 ± 13%, electrical storm: 24%). In idiopathic PVC/VT, MVCs were observed in 2.4 % (4.0% in males vs. 0.9% in females, P <0.01). In SHD, the rate of MVCs reached 3.5 % (2.8% in males vs. 9.4% in females, P <0.00001). Based on the multivariable regression model, the composite risk score to predict MVCs was proposed that was calculated as a sum of risk points for age (0, 1, 2, and 3 points for <50, 50–59, 60–69, and ≥70 years, respectively), female gender (2 points), and serum creatinine >1.3mg/dL (2 points), range 0–7 (Figure). While in an idiopathic setting, MVCs were more frequent in males, which may reflect a higher proportion of more complex LV ablations and arterial access, there was a significant female predominance in MVCs in SHD. The composite risk score predicts the risk of MVCs independently of VT cause.

Vascular access for transcatheter aortic valve replacement: A network meta-analysis

BackgroundThe choice of an alternative access for transcatheter aortic valve replacement (TAVR) remains controversial when transfemoral (TF) access is not feasible. MethodsWe conducted a network meta-analysis to compare the outcomes of TAVR via various peripheral vascular accesses. MEDLINE and EMBASE were searched through July 2022 to identify studies that investigated outcomes in patients who underwent TAVR via TF, trans-subclavian (Tsc), transcarotid (TC), or transcaval (Tcav) access. A network meta-analysis was conducted via random-effects model. Outcomes of interest were major or life-threatening bleeding, stroke, major vascular complication, and 30-day mortality. ResultsNo randomized trial was identified. Our analysis included 33 observational studies that enrolled a total of 43,455 patients who underwent TAVR via TF (n = 36,202), Tsc (n = 3869), TC (n = 3066), or Tcav (n = 318) access. The risk of major or life-threatening bleeding was higher via Tsc compared with TF [odds ratio (OR); 95 % confidence interval (CI) =1.51 (1.03–2.23), p = 0.034]. The risk of stroke was higher via Tsc compared with TF and Tcav [OR (95 % CI) =2.00 (1.14–3.52), p = 0.018, OR (95 % CI) =2.43 (1.03–5.74), p = 0.044, respectively]. The risk of major vascular complications was lower via TC compared with Tsc, and Tcav and higher with Tcav compared with TF and Tsc. 30-day mortality was higher via Tsc compared with TF. Tsc was associated with higher risk of major or life-threatening bleeding compared with TF, and higher risk of stroke compared to TF and Tcav. Tcav had the highest risk of major vascular complications. ConclusionIn patients who underwent TF, Tsc, TC, or Tcav TAVR, Tsc had a higher rate of stroke compared to TF and Tcav, and major or life-threatening bleeding compared to TF. The rate of major vascular complications in Tcav was the highest among the four approaches.

Meta-Analysis on Transcarotid Versus Transfemoral and Other Alternate Accesses for Transcatheter Aortic Valve Implantation

Transcarotid access has emerged as the preferred access site for transcatheter aortic valve implantation (TAVI) in patients with prohibitive iliofemoral anatomy. This study aimed to compare outcomes with transcarotid with those of other accesses in patients who underwent TAVI. Cochrane, EMBASE, and MEDLINE databases were searched for all published studies that compared outcomes with transcarotid with those of other accesses (transfemoral, transaxillary/subclavian, transaortic, and transapical) in patients who underwent TAVI. The primary outcome was all-cause mortality. Secondary outcomes included major bleeding, major vascular complications, stroke, myocardial infarction, permanent pacemaker implantation, and peri-aortic valve insufficiency. We included 22 observational studies with a total of 11,896 patients. Outcomes were reported during hospitalization and at 1-month follow-up. The transcarotid approach had higher mortality at 1month (3.7% vs 2.6%, p=0.02) but lower major vascular complications during hospitalization (1.5% vs 3.4%, p=0.04) than did transfemoral access. The transcarotid approach had lower major vascular complications (2% vs 2.3%, p=0.04) than did the transaxillary/subclavian but higher major bleeding (5.3% vs 2.6%, p=0.03). The transaortic approach was associated with higher in-hospital (11.7% vs 1.9%, p=0.02) and 1-month mortality (14.4% vs 3.9%, p=0.007) rates than was transcarotid access. The transcarotid approach numerically reduced mortality and the risk of major vascular complications and major bleeding compared with the transapical approach; however, this did not reach statistical significance. The transcarotid approach did not increase the risk of stroke compared with transfemoral or the other alternative accesses. In conclusion, the transcarotid or transaxillary/subclavian approach had associated comparable outcomes that were better than those of the transapical and transaortic approaches. There was no difference in stroke risk between transcarotid access and other accesses.

Abstract 143: Sepsis And Risk Of Major Postoperative Vascular Complications

Introduction: Stroke, myocardial infarction (MI), and pulmonary embolism (PE) greatly increase postoperative morbidity and mortality. Sepsis has been linked to increased risk of major vascular events, but the risk related to sepsis exposure throughout the postoperative period is uncertain. Hypothesis: Perioperative sepsis exposure increases the 30-day risk of postoperative stroke, myocardial infarction (MI), and pulmonary embolism (PE). Methods: Data were obtained from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), a formulaic sampling of surgical cases from participating United States institutions that prospectively collects demographic, clinical, surgical and 30-day outcome data. Sepsis was defined by systemic inflammatory response syndrome with either positive blood culture or evidence for infection found intraoperatively, and severe sepsis/shock as sepsis with evidence of organ dysfunction or circulatory dysfunction. We used mixed-effects Cox proportional hazard models, treating type of surgery as a random effect, to estimate the hazard ratios for major vascular complications due to sepsis and severe sepsis/shock exposure, adjusting for otherrisk factors. Results: We studied 6,614,937 surgical procedures. There were 201,230 cases with sepsis and an additional 78,052 cases of severe sepsis/shock. Outcomes included 13,939 strokes, 23,600 MIs, 21,893 PEs, and 1690 cases with multiple major vascular complications. Exposure to sepsis (HR 1.98, 95% confidence interval 1.91 to 2.06) or severe sepsis/shock (HR 3.27, 3.14 to 3.40) increased the risk of major vascular complications with larger effect than other established risks. Sepsis improvement within the preoperative period was associated with reduced risk (HR 0.82, 0.77 to 0.88). These findings were consistent in separate models for each complication. Conclusions: Sepsis approximately doubles and severe sepsis or shock triples the 30-day postoperative risk of major vascular complications. Improvement in sepsis severity prior to operation is associated with a 20% risk reduction.

Abstract 14335: Vascular Complications and Outcomes Following Transcatheter Aortic Valve Replacement in Patients on Chronic Steroids Therapy. A Meta-Analysis

Introduction: Chronic steroids therapy was reportedly linked to increased vascular complications (VC) following invasive vascular procedures. However, its association with VC after transcatheter aortic valve replacement (TAVR) remained uncertain, with conflicting results being reported. We aimed to compare the rate of vascular complications and outcomes between patients with and without chronic steroid use after TAVR. Methods: We conducted a comprehensive literature search in PubMed, Embase and Cochrane databases for relevant studies. Endpoints were described according to Valve Academic Research Consortium-2 definitions and were assessed within 30 days of TAVR. Effect sizes were pooled using the DerSimonian and Laird random-effects model as risk ratio (RR) with 95% confidence intervals (CI). Results: 5 studies with 6136 patients undergoing TAVR (328 steroids, 5808 non-steroids) were included in the analysis. Patients on chronic steroids were younger (mean age 80.2 vs 82.3 years) and were more likely to be female (56% vs 54%). Patients on chronic steroids had a higher risk of major vascular complications (RR 2.32, 95% CI 1.73-3.11, p&lt;0.001), major bleeding (RR 1.61, 95% CI 1.27-2.05, p&lt;0.001) and aortic annulus rupture (RR 4.66, 95% CI 1.67-13.01, p&lt;0.001). There was no significant difference in terms of minor vascular complications (RR 1.43, 95% CI 1.00-2.04, p=0.05), in-hospital mortality (RR 1.86, 95% CI 0.74-4.70, p=0.19) and 30-day mortality (RR 1.14, 95% CI 0.53-2.46, p=0.74) between both groups. Conclusion: Chronic steroid therapy is associated with increased rate of major VCs, major bleeding and aortic annulus rupture following TAVR. Further randomized controlled trials were encouraged to confirm these findings.

Delayed Diagnosis of Brachiocephalic Pseudoaneurysm and Carotid Artery Dissection Following Invasive Coronary Angiography

The transradial artery approach is the preferred access route for coronary angiography. The risk of major vascular complications is 0.2% and typically involves hematomas arising from the radial, brachial, or subclavian artery, with pseudoaneurysms of the radial artery previously described.1,2 Brachiocephalic pseudoaneurysm is a rare and anatomically challenging clinical entity from a diagnostic and therapeutic perspective.3 To date, brachiocephalic artery pseudoaneurysms with carotid artery involvement as a complication of coronary angiography have been unreported, with a paucity of literature to guide management.

Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Implantation.

During the last decade, transcatheter aortic valve implantation (TAVI) has evolved as a well-established therapy for aging patients suffering from symptomatic severe aortic valve stenosis. This is also reflected in the recently updated international guidelines on managing patients with valvular heart disease. A transfemoral(TF) TAVIapproach has proven superior to alternative access strategies. With the introduction of intravascular lithotripsy (IVL), patients with calcified iliofemoral vascular disease and borderline intraluminal diameters have also become candidates for percutaneous TF-TAVI. Moreover, IVL reduces the risk of major vascular complications by modifying the superficial and deep vascular calcium, thereby changing the vessel compliance and controlling luminal expansion. In this way, IVL has shown to safely facilitate TF delivery of TAVI devices in patients with calcified peripheral artery disease. The present article aims to provide a detailed step-by-step description on how to perform IVL-assisted TF-TAVI safely and efficiently. Furthermore, a literature review on the outcomes obtained with this technology is included, along with a concise discussion on this unique TAVI approach.

426 Percutaneous or surgical access for transfemoral transcatheter aortic valve implantation: a propensity matched analysis of a multicentre registry

Abstract Aims The transfemoral (TF) approach appeared to be the safest and the broadest used approach in TAVI, characterized by a lower rate of periprocedural bleedings and vascular complications and is currently recommended by the guidelines as a first line approach when feasible. If in the early experience TF access was achieved using a surgical cutdown approach, through the last years, there has been increasing evidence of the safety and efficacy of a fully percutaneous approach over a surgical access, albeit available evidences are controverting and mostly including first generation prostheses and high risk patients. The aim of the study is to compare percutaneous and surgical access in a large, real-word, multicentre of TF TAVI. Methods and results Consecutive patients undergoing successful TF TAVI were prospectively enrolled in local clinical registries of five high volume centres in Italy: IRCCS Ospedale Policlinico San Martino (Genoa), IRCCS Policlinico San Donato (Milan), Città Della Salute e della Scienza, (Turin), Ospedale Niguarda Ca’ Granda (Milan), Magna Graecia University, (Catanzaro), between January 2014 to December 2019. Univariate and multivariate analysis using IPTW were performed. A total of 1946 TF TAVI patients (female 42.8%) were prospectively included. Patients underwent surgical access had a significantly higher surgical risk (STS score of 8.9 vs. 6.4, P &amp;lt; 0.001, and EuroSCORE of 15.1 vs. 8.7, P &amp;lt; 0.001, respectively). Overall survival was comparable between the two groups (HR: 1.14, 95% CI: 0.76–1.71). Patients who underwent surgical access experienced more VARC-2 major and VARC-2 minor vascular complications (13% vs. 7%, P = 0.003 and 11% vs. 6.1%, P = 0.007, respectively) and more VARC-2 major/life threatening and minor bleeding (27.4% vs. 17.8, P = 0.001, and 9.6% vs. 2.1%, P &amp;lt; 0.001, respectively). After IPTW adjustment, surgical access was associated with an increased risk of major vascular complications (HR: 3.32, 95% CI: 1.84–5.97), minor bleeding (HR: 4.24, 95% CI: 1.16–15.54) and stage 2–3 AKI (HR: 2.60, 95% CI: 1.07–6.33). Conclusions The performance of the percutaneous transfemoral TAVI approach was safe and feasible and resulted in fewer major vascular complications, bleedings and AKI than the surgical femoral isolation. Procedural time and hospital length were also lower in the percutaneous group. Routine application of the percutaneous approach might reduce acute complications in patients undergoing transfemoral TAVI and reduce procedural time and hospital length.

Radial versus femoral secondary access for transcatheter aortic valve replacement: A systematic review and meta-analysis.

We aimed to evaluate the risk of procedural complications after TAVR using secondary radial access (RA) versus femoral access (FA) through a systematic review and meta-analysis of the published literature. Transcatheter aortic valve replacement (TAVR) entails both large-bore arterial access for device delivery and secondary arterial access for hemodynamic and imaging assessments. It is unknown whether RA versus FA for this secondary access reduces the risk of procedural complications. We searched PubMed, Embase, the Cochrane Library, and Web of Science for observational studies comparing TAVR procedural complications in RA versus FA. Event rates were compared via weighted summary odds ratios using the Mantel-Haenszel method. Six manuscripts encompassing 6132 patients were included. Meta-analysis showed that RA reduced the risk of major vascular complications (OR 0.58, 95% CI 0.43-0.77, p< 0.001, I2 0%) and major/life-threatening bleeding (OR 0.46, 95% CI 0.36-0.59, p< 0.001, I2 0%) as compared to FA for secondary TAVR access. We also observed a reduction 30-day mortality (OR 0.55, 95% CI 0.38-0.79, p= 0.001, I2 0%), acute kidney injury (OR 0.45, 95% CI 0.34-0.60, p< 0.001, I2 0%), and stroke and transient ischemic attack (OR 0.43, 95% CI 0.27-0.67, p< 0.001, I2 0%). RA reduced the risk of major vascular and bleeding complications when compared to FA for secondary access in TAVR. RA is associated with reduced risk of other adverse outcomes including mortality, but these associations may be related to selection bias and confounding given the observational study designs.

Impact of anemia on short-term outcomes after TAVR: A subgroup analysis from the BRAVO-3 randomized trial.

To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. The BRAVO-3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels <13 g/dl in men and <12 g/dl in women) or absence of anemia. The primary outcomes were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or bleeding) and major bleeding (Bleeding Academic Research Consortium ≥3b) at 30 days. Among 798 patients with available baseline hemoglobin levels, 427 (54%) were anemic of whom 221 (52%) received bivalirudin. There were no significant differences in NACE and major bleeding at 30 days between patients with and without anemia, irrespective of the type of anticoagulant used (pinteraction =0.71 for NACE, pinteraction =1.0 for major bleeding). However, anemic patients had a higher risk of major vascular complications (adjusted OR 2.43, 95% CI 1.42-4.16, p=0.001), and acute kidney injury (adjusted OR 1.74, 95% CI 1.16-2.59, p=0.007) compared to non-anemic patients at 30 days. Anemia was not associated with a higher risk of NACE or major bleeding at 30 days after TAVR without modification of the treatment effects of periprocedural anticoagulation with bivalirudin versus UFH.

Gender differences in major vascular complications of catheter ablation for atrial fibrillation.

Catheter ablation (CA) for atrial fibrillation (AF) has a considerable risk of procedural complications. Major vascular complications (MVCs) appear to be the most frequent. This study investigated gender differences in MVCs in patients undergoing CA for AF in a high-volume tertiary center. A total of 4734 CAs for AF (65% paroxysmal, 26% repeated procedures) were performed at our center between January 2006 and August 2018. Patients (71% males) aged 60 ± 10 years and had a body mass index of 29 ± 4 kg/m2 at the time of the procedure. Radiofrequency point-by-point ablation was employed in 96.3% of procedures with the use of three-dimensional navigation systems and facilitated by intracardiac echocardiography. Pulmonary vein isolation was mandatory; cavotricuspid isthmus and left atrial substrate ablation were performed in 22% and 38% procedures, respectively. MVCs were defined as those that resulted in permanent injury, required intervention, or prolonged hospitalization. Their rates and risk factors were compared between genders. A total of 112 (2.4%) MVCs were detected: 54/1512 (3.5%) in females and 58/3222 (1.8%) in males (p < .0001). On multivariate analysis, lower body height was the only risk factor for MVCs in females (p = .0005). On the contrary, advanced age was associated with MVCs in males (p = .006). Females have a higher risk of MVCs following CA for AF compared to males. This difference is driven by lower body size in females. Low body height in females and advanced age in males are independent predictors of MVCs. Ultrasound-guided venipuncture lowered the MVC rate in males.

Transcatheter versus surgical aortic valve replacement: an updated systematic review and meta-analysis with a focus on outcomes by sex

Abstract Background and purpose Women at increased surgical risk have been shown to have better outcomes with transcatheter aortic valve implantation (TAVI) as compared to surgical valve replacement (SAVR). With the scope of TAVI moving into low-surgical risk patients we aimed to update the current literature to include the new low-risk randomized controlled trial data in investigating outcomes by sex. Methods We systematically searched MedlineOVID, PubMed, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and reference lists for relevant randomised controlled trials (RCTs) comparing TAVI to SAVR published prior to October 7th 2019. Data extraction was performed by two independent authors and included trial design details, baseline characteristics and outcome data stratified by sex. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Quantitative synthesis of pooled data was performed using Mantel-Haenszel fixed or random effects model. Q-statistic and the I2 test were used for assessment of heterogeneity. Results Our search yielded eight RCTs included in the final quantitative synthesis. The overall pooled cohort was 8,040, of whom 41.4% were female. Women had significantly lower rates of one-year all-cause mortality and one-year composite endpoint with TAVI as compared to SAVR. The selective mortality benefit with TAVI over SAVR in women did not persist to five-years. At 30-days, women demonstrated lower rates of major bleeding and acute kidney injury following TAVI compared to SAVR. For men, these outcomes were similar regardless of type of intervention. Both sexes were at increased risk of major vascular complications with TAVI as compared to SAVR, however women demonstrated nearly double the odds of major vascular complication with TAVI compared to men. Conclusion Our updated meta-analysis demonstrates that at one-year women undergoing TAVI have significantly lower mortality and better safety outcomes compared to those undergoing SAVR. These benefits are not seen in men. In the new low-risk era, these results are ever more important for guiding appropriate patient selection. Composite endpoint at one-year Funding Acknowledgement Type of funding source: None

Transcatheter Versus Surgical Aortic Valve Replacement: An Updated Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex

Women at increased surgical risk have been shown to have better outcomes with transcatheter aortic valve implantation (TAVI) as compared to surgical valve replacement (SAVR). With the scope of TAVI moving into low-surgical risk patients, we aimed to update the current literature to include the new low-risk randomised controlled trial (RCT) data in investigating outcomes by sex. We systematically searched MEDLINE (Ovid), PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and reference lists for relevant RCTs comparing TAVI to SAVR published prior to 4 May 2020. Data extraction was performed by two independent authors and included trial design details, baseline characteristics and outcome data stratified by sex. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool. Quantitative synthesis of pooled data was performed using Mantel-Haenszel fixed or random effects model. Q-statistic and the I2 test were used for assessment of heterogeneity. Our search yielded eight RCTs included in the final quantitative synthesis. The overall pooled cohort was 8,040, of whom 41.4% were female. Women had significantly lower rates of one-year all-cause mortality (12.2% vs 17.7%, pooled OR 0.59, 95% CI 0.40-0.86) and one-year composite endpoint (9.7% vs 12.4%, pooled OR 0.73, 95% CI 0.58-0.92) with TAVI as compared to SAVR. The selective mortality benefit with TAVI over SAVR in women did not persist to 5 years (pooled HR 1.01, 95% CI 0.87-1.17). At 30 days, women demonstrated lower rates of major bleeding and acute kidney injury following TAVI compared to SAVR. For men, these outcomes were similar regardless of type of intervention. Both sexes were at increased risk of major vascular complications with TAVI as compared to SAVR, however women demonstrated nearly double the odds of major vascular complication with TAVI compared to men. Our updated meta-analysis demonstrates that at one-year women undergoing TAVI have significantly lower mortality and better safety outcomes compared to those undergoing SAVR. These benefits are not seen in men. In the new low-risk era, these results are ever more important for guiding appropriate patient selection.

Meta-analysis Comparing Transradial Versus Transfemoral Secondary Access in Transcatheter Aortic Valve Implantation

Up to a quarter of vascular complications during transcatheter aortic valve implantation (TAVI) result from secondary access via the femoral artery (FA). The radial artery (RA) is increasingly used as an alternative to the FA for secondary access in TAVI. Limited data exist on the outcomes of RA secondary access versus FA secondary access. We therefore conducted a systematic review and meta-analysis comparing secondary access sites. PubMed, EMBASE, Scopus, Cochrane library and CINAHL were searched systematically for studies comparing RA and FA as secondary access sites for TAVI. Primary outcomes of interest were vascular complications and major bleeding. Secondary outcomes included all-cause mortality, stroke and myocardial infarction (MI). Risk ratio (RR), standardized mean difference and corresponding 95% confidence intervals (CI) were calculated using a random effects model. Six observational studies comprising 6,373 patients (RA: 1,514, FA: 4,859) met inclusion criteria. Secondary access was utilized for aortography during valve deployment and to manage primary access site complications. Procedural characteristics were similar in both groups. RA was associated with a lower risk of major bleeding (RR: 0.51, 95% CI: 0.40 to 0.64, p <0.00001). No statistically significant difference was observed in the incidence of overall vascular complications, however, the risk of major vascular complications was lower with RA (RR: 0.45, 95% CI: 0.32 to 0.63, p <0.00001). The incidence of stroke and all-cause mortality was lower in RA, whereas no difference was observed in the risk of MI. In conclusion, our meta-analysis suggests that RA secondary access is associated with better outcomes for TAVI than FA.

Comparison of transcarotid vs. complex transfemoral access in patients undergoing transcatheter aortic-valve implantation (TAVI)

Transfemoral (TF) access is considered as the default approach in patients undergoing TAVI. However, ilio-femoral anatomic considerations as diameter, tortuosities and calcifications have to be taken into account and alternatives routes as transcarotid (TC) may be considered. This study compare outcomes between “complex” TF (cTF) and TC in patients undergoing TAVI. All consecutive patients undergoing TAVI via cTF and TC in our center between 2015 and 2018 were included in this retrospective study. A cTF approach was defined as a common femoral artery < 6.5 mm of diameter with at least severe calcifications or severe tortuosity assessed by CT scan. TF or TC approach was performed according to the heart team decision. The primary endpoint was 1-month outcomes including mortality, major vascular complications, bleeding and stroke. The study included 131 patients with 51 of them who underwent cTF TAVI (39,2%) whereas 80 patients underwent TC TAVI (60,8%). The mean age was 81.7 ± 6.9 years. Patients in the TC group had a higher operative risk profile (STS score 5.5 vs 7.7; P = 0.01), a lower left ventricular fraction (44% vs 53%; P ≤ 0.001) and a higher incidence of coronary artery disease (61% vs 38%, P = 0.04) compared with cTF patients. Prevalence of female was higher in the cTF group compared to the TC group (66% vs 31% P ≤ 0.0001). There were no significant differences in term of 30 day mortality (1.9% vs. 2.5%; P = 1) or stroke rate (1.9% vs. 2.5%; P = 1) or bleeding rate (11.7% vs. 7.5%; P = 0.53) between the cTF group and the TC group but major vascular complications occurred with a higher frequency in the cTF group (cTF:11.7%; TC:2.5%; P = 0.05) Despite a higher risk profile patients, the TC approach provided similar results in term of mortality, stroke, bleeding but was associated with a lower risk of major vascular complications. Carotid access could be considered in challenging femoral anatomy for TAVI procedures.

Access site complications following Impella-supported high-risk percutaneous coronary interventions

Mechanical circulatory support (MCS) devices are increasingly used to provide hemodynamic stability for patients with severe coronary artery disease, comorbidities, and/or impaired hemodynamics during high-risk percutaneous coronary interventions (PCI). Vascular access site complications, particularly those due to the use of large-bore sheaths, may limit outcomes in these patients. The aim of this study was to investigate the incidence and predictors of vascular complications in protected high-risk PCIs. Therefore, we included patients undergoing high-risk PCI with an Impella device from January 2016 to August 2018. Vascular complications were graded according to ‘Valve Academic Research Consortium-2’, a definition routinely used in transcatheter valve implantation procedures. In total, 61 patients (mean age 72 ± 11 years, 79% male, SYNTAX score 33 ± 7) were included, and angiographic- and fluoroscopic-guided vascular access was used for Impella implantation in all patients. Major vascular complications occurred in 5 male patients (8%). All major vascular complications were treated conservatively without the need for surgical intervention, and only one patient received a transfusion of three erythrocyte concentrates. Regression analysis revealed that patients with peripheral arterial disease of the lower extremities are at higher risk of major vascular complications. In conclusion, the utilization of Impella using a standardized protocol for angiographic- and fluoroscopic-guided vascular access was associated with a low rate of vascular complications.