Major Vascular Complications Research Articles

Abstract 12210: Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation vs Interruption of Peri-Procedural Anticoagulation: A Meta-Analysis

Introduction: Approximately 33% of patients undergoing transcatheter aortic valve replacement (TAVR) have an indication for long-term anticoagulation. In clinical routine, anticoagulation is often discontinued 2 to 4 days before TAVR. The purpose of this meta-analysis was to compare the safety and efficacy of TAVR in patients with per-procedural continuation vs interruption of anticoagulation. Methods: An electronic search was performed using PubMed and Ovid Medline from inception to May 2022. The primary outcome of interest was life-threatening or major bleeding. The secondary outcomes were all-cause mortality, stroke, vascular complications, need for blood transfusion, and closure device failure. Results: Three observational studies were included in our final analysis which consisted of 2,286 patients, with anticoagulation being continued in 1,069 patients and interrupted in 1,217 patients. Although, there was no significant difference in our primary outcome of life-threatening or major bleeding between both groups, there was a trend toward decreased risk of bleeding in patients who were continued on anticoagulation (RR: 0.81; CI: 0.65 to 1.0; I 2 : 0%, p=0.05). There was a significantly lower risk of stroke (RR: 0.55; CI: 0.35 to 0.88; I 2 : 0%, p=0.01) and need for blood transfusion (RR: 0.72; CI: 0.59 to 0.87; I 2 : 0%, p<0.01) in patients who were continued on anticoagulation as compared to those in whom anticoagulation was interrupted. There was no significant difference in the all-cause mortality (RR: 0.76; CI: 0.49 to 1.19; I 2 : 10%, p=0.24), major vascular complications (RR: 0.86; CI: 0.68 to 1.09; I 2 : 0%, p=0.22), or closure device failure (RR: 0.90; CI: 0.51 to 1.59; I 2 : 0%, p=0.72) between both the cohorts. Conclusions: In a patient undergoing TAVR who requires long-term anticoagulation, continuing anticoagulation is superior to interrupting anticoagulation in reducing the risk of stroke without any increase in life-threatening or major bleeding.

Abstract 14407: Clinical Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid versus Tricuspid Aortic Valve Stenosis

Introduction: Transcatheter aortic valve replacement (TAVR) has proven to be safe and efficacious in patients with tricuspid aortic valve (TAV) stenosis. However, due to its anatomic complexity, bicuspid aortic valve (BAV) stenosis has been excluded from previous trials, and data remain limited regarding TAVR in this group of patients. Methods: We searched the databases systematically for relevant studies from inception to March 2022. The primary focus was all-cause mortality at 1-year. Additional outcomes included 30-day mortality, 30-day stroke, and 30-day major vascular complications. Results: We included 28 studies with a total of 346,033 patients who underwent TAVR, of which 17,835 patients had BAV stenosis. The risks of 1-year mortality and 30-day major vascular complications were similar between the 2 groups. However, patients with BAV who underwent TAVR had a higher risk of 30-days mortality (BAV 2.3% vs TAV 2.2%, p=0.02) and 30-day stroke (BAV 2.2% vs TAV 1.8%, p=0.01). A subgroup analysis of 23,623 matched patients of whom 49.5% had BAV stenosis was performed. The risk of 1-year mortality was lower in patients with BAV compared to TAV (BAV 5.8% vs TAV 6.8%, p=0.009). Risks of 30-day mortality, and 30-day major vascular complication were similar between the two groups. However, the risk of 30-day stroke was higher in the BAV group (BAV 2.2% vs TAV 1.7%, p=0.02). Conclusions: In our meta-analysis, among patients who underwent TAVR for aortic stenosis, there was no significant difference between BAV vs TAV in outcomes, except for higher risk of 30-days mortality and stroke. Among matched groups, patients with BAV stenosis undergoing TAVR had comparable outcomes to patients with TAV stenosis except for higher risk of stroke and lower risk of 1-year mortality in BAV group.More studies, specifically randomized trials, are still warranted to further assess efficacy, safety and reassure the long-term outcomes in this group of patients.

Abstract 14277: Comparison of Three Vascular Closure Devices for Vascular Access Closure After Cardiac Electrophysiology Procedures

Introduction: Vascular closure devices are commonly used for EP procedures to achieve rapid hemostasis. Different devices using different mechanisms of action are available, but the potential contribution of each type to the incidence of vascular complications is not clear. Methods: This is a single center, prospective study in which 138 contemporaneous patients undergoing EP procedures were categorized according to the vascular closure device type used: Vascade (collagen plug, n=57), Perclose (suture, n=41), and SiteSeal (external compression, n=40). The primary endpoint was access-related major vascular complications. Secondary endpoints included time to ambulation and delayed access-site bleeding requiring additional manual pressure. Results Mean age and BMI 68±11 years and 29.7±6.2 Kg/m 2 , 46 (33%) were female, 121 (88%) were on uninterrupted antithrombotic therapy (71% OAC, 14% OAC/APLT, 3% APLT). Femoral vein access was obtained in all, bilaterally in 113 (82%), with a mean of 3±1 access sites per patient and a sheath size ranging from 6- to 23-Fr. Femoral arterial access was obtained in 14 (10%), once per patient, with a sheath size ranging from 5- to 8-Fr. There were no arterial access complications. On the venous side, hematomas occurred in 3/57 (5%) of the Vascade group, 1/41 (2%) of the Perclose group, and 0/40 (0%) of the SiteSeal group (p=ns for all comparisons). Delayed access-site bleeding occurred in 5/57 (9%) of the Vascade group, 5/41 (12%) of the Perclose group, and 7/40 (18%) of the SiteSeal group (p=ns for all comparisons). Time to ambulation was comparable between groups (minutes: 139±51 Vascade, 137±34 Perclose, 123±11 SiteSeal, p=ns). Conclusion Vascade, Perclose, and SiteSeal are comparable in term of vascular complications and time to ambulation for patients undergoing EP procedures.

Abstract 12367: Tavr Outcomes in Overweight and Obese Patients: Systematic Review and Meta-Analysis

Introduction: In recent years, the “obesity paradox” has been shown in studies demonstrating better outcomes in overweight and obese patients undergoing percutaneous or surgical cardiovascular procedures. This study compares the effect of body-mass index (BMI) on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Methods: A comprehensive systematic search was conducted in PubMed, Web of Science, and Cochrane library for relevant studies. Studies were included if they had categories for BMI (normal-weight, overweight, and obese) and reported the outcomes of TAVR in each group. Random-effects using STATA was performed for the meta-analysis. Results: 34 studies with 96,093 patients were included in our study. Overweight and obese patients had a significantly lower rate of 1-year all-cause mortality, long-term all-cause mortality and moderate to severe aortic regurgitation compared to normal-weight patients (Figure 1). Incidence of 30-day myocardial infarction was lower in overweight patients, and 1-year stroke incidence was significantly lower in obese patients compared with normal cases. In contrast, permanent pacemaker implantation was more observed in overweight and obese patients. There was no significant difference in outcomes in underweight patients compared to normal-weight ones except for a higher rate of major vascular complications in underweight cases. Conclusions: Our analysis showed improved outcomes in terms of all-cause mortality and aortic regurgitation in overweight and obese patients undergoing TAVR compared to normal-weight patients.

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<0.001), major bleeding (RR 1.61, 95% CI 1.27-2.05, p<0.001) and aortic annulus rupture (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 (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.

Abstract 14790: Impact of Pre-Frailty and Frailty in Women Undergoing TAVR: Insights From the WIN-TAVI Registry

Background: Frailty has been shown to significantly affect outcomes after transcatheter aortic valve replacement (TAVR). The impact of pre-frailty on TAVR outcomes in women is still unclear. Aim: To assess the impact of pre-frailty and frailty on outcomes in women enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry. Materials and methods: WIN-TAVI was a multinational, prospective, observational registry, which enrolled women at intermediate or high preoperative risk undergoing TAVR. Patients included in this registry were divided into three groups, based on the number of fulfilled Fried frailty criteria: non-frail (no criteria, reference group), pre-frail (1-2 criteria) and frail (≥3 criteria). The primary outcome was the Valve Academic Research Consortium (VARC)-2 efficacy endpoint at 1-year after TAVR. The key secondary outcome was VARC-2 safety endpoint. Results: Out of 1,019 patients, 264 (25.9%) were pre-frail and 33 (3.2%) frail. The risk of VARC-2 efficacy endpoint at 1-year was increased in pre-frail (19.7%, HR 1.36, 95% CI 0.98-1.89) and frail (24.2%, HR 1.74, 95% CI 0.85-3.57) as compared to non-frail patients (14.9%, reference group), although it didn’t reach statistical significance. The risk of VARC-2 safety endpoint was significantly higher in pre-frail (25.8%, HR 1.43, 95% CI 1.07-1.91) and frail (42.4%, HR 2.77, 95% CI 1.60-4.80) than in non-frail subjects (19%, reference group); this difference was driven by an excess of major vascular complications and life-threatening or major bleeding in the pre-frail and frail group. In addition, in pre-frail patients hospitalizations for heart failure or valve-related symptoms at 1-year were higher than in non-frail patients. Conclusion: In women at intermediate or high preoperative risk undergoing TAVR, pre-frailty and frailty increased the risk of safety endpoints such as vascular complications and major bleeding.

Trajectories of Cardiac Function Following Treatment With an Impella Device in Patients With Acute Anterior ST-Elevation Myocardial Infarction

BackgroundLeft ventricular (LV) unloading via the percutaneous micro-axial Impella pump is increasingly used in patients with anterior ST-segment elevation myocardial infarction (STEMI) and overt cardiogenic shock. In this context, the evolution of cardiac function and dimensions beyond hospital discharge remains uncertain. We aimed to characterize echocardiographic changes over time in patients with acute anterior STEMI treated with an Impella device. MethodsFrom an ongoing prospective registry, consecutive patients with acute anterior STEMI managed with an Impella device were extracted. Transthoracic echocardiography was performed at index hospitalization and at first outpatient follow-up. Predictors of response, defined as a ≥ 10% absolute increase in left ventricular ejection fraction (LVEF) at follow-up, were sought. ResultsA total of 66 patients (89.4% male, aged 64.3 ± 11.6 years) with anterior STEMI were treated with an Impella device in the first 24 hours of hospitalization, from 2014 to 2022. In-hospital mortality was 24%. Major bleeding and vascular complications requiring surgery occurred in 24% and 11% of patients, respectively. At baseline, mean LVEF was 34% ±12%. At follow-up, survivors showed a significant increase in LVEF (P < 0.0001), whereas LV dimensions, diastolic parameters, and measures of right ventricular dimension and function remained stable. Overall, 28 patients had a ≥ 10% absolute increase in LVEF at follow-up. Baseline creatinine was the only significant predictor of response at univariate analysis. ConclusionsAmong patients with anterior STEMI requiring mechanical hemodynamic support with an Impella device, the majority of survivors showed a sustained increase in LV function, without evidence of adverse remodelling. This signal warrants further investigation in dedicated trials.

Impact of prior coronary artery bypass grafting on periprocedural and short-term outcomes of patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis.

The effect of prior coronary artery bypass graft (CABG) on the outcomes of transcatheter aortic valve replacement (TAVR) remains incompletely characterized. In this meta-analysis, we investigated the impact of prior CABG on TAVR outcomes. A systematic search was conducted in PubMed, Google Scholar, and Cochrane databases from inception to 24 July 2022, using the search terms 'TAVR', 'CABG', 'peri-procedural complications', and 'mortality'. The major outcomes were peri-procedural complications, intraprocedural mortality, 30-day mortality, and 30-day cardiac mortality. We used random-effects models to aggregate data and to calculate pooled incidence and risk ratios with 95% confidence intervals (CIs). Among 116 results from the systematic search, a total of 8 studies (5952 patients) were included. Compared to patients without previous CABG, patients with prior CABG undergoing TAVR were younger, predominantly male sex, had more comorbidities, higher rates of peri-procedural myocardial infarction (MI) [relative risk (RR) 1.93; 95% CI, 1.09-3.43; P = 0.03], but lower rates of stroke (RR 0.71; 95% CI, 0.51-0.99; P = 0.04), major vascular complications (RR 0.70; 95% CI, 0.51-0.95; P = 0.02), and major bleeding (RR 0.70; 95% CI, 0.56-0.88; P = 0.002). There were no significant differences between the two cohorts in rates of pacemaker implantation, cardiac tamponade, acute kidney injury, intra-procedural mortality, 30-day mortality, and 30-day cardiac mortality. Among patients undergoing TAVR, a history of prior CABG was not associated with an increased risk of periprocedural complications (except for acute MI) or short-term mortality compared to those without CABG.

Incidence, Clinical Characteristics, and Impact of Absent Echocardiographic Signs in Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.

Echocardiography is the primary imaging modality for diagnosis of infective endocarditis (IE) in prosthetic valve endocarditis (PVE) including IE after transcatheter aortic valve implantation (TAVI). This study aimed to evaluate the characteristics and clinical outcomes of patients with absent compared with evident echocardiographic signs of TAVI-IE. Patients with definite TAVI-IE derived from the Infectious Endocarditis after TAVI International Registry were investigated comparing those with absent and evident echocardiographic signs of IE defined as vegetation, abscess, pseudo-aneurysm, intracardiac fistula, or valvular perforation or aneurysm. Among 578 patients, 87 (15.1%) and 491 (84.9%) had absent (IE-neg) and evident (IE-pos) echocardiographic signs of IE, respectively. IE-neg were more often treated via a transfemoral access with a self-expanding device and had higher rates of peri-interventional complications (eg, stroke, major vascular complications) during the TAVI procedure (P < .05 for all). IE-neg had higher rates of IE caused by Staphylococcus aureus (33.7% vs 23.2%; P = .038) and enterococci (37.2% vs 23.8%; P = .009) but lower rates of coagulase-negative staphylococci (4.7% vs 20.0%, P = .001). IE-neg was associated with the same dismal prognosis for in-hospital mortality in a multivariate binary regression analysis (odds ratio: 1.51; 95% confidence interval [CI]: .55-4.12) as well as a for 1-year mortality in Cox regression analysis (hazard ratio: 1.10; 95% CI: .67-1.80). Even with negative echocardiographic imaging, patients who have undergone TAVI and presenting with positive blood cultures and symptoms of infection are a high-risk patient group having a reasonable suspicion of IE and the need for an early treatment initiation.

Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices

BackgroundProcedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described. ObjectivesThe aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device. MethodsThe National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX. ResultsThe study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001). ConclusionsTranscatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.

Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation

The failure rate of vascular closure devices remains a significant cause of major vascular complications in contemporary transcatheter aortic valve implantation practice. This research aimed to evaluate use of the Angio-Seal device in a bailout context in the setting of incomplete hemostasis following use of dual Perclose ProGlide devices in patients undergoing transfemoral transcatheter aortic valve implantation. A total of 185 patients undergoing transfemoral transcatheter aortic valve implantation with either dual Per-close ProGlide (n = 139) or a combination of dual Perclose ProGlide and Angio-Seal (n = 46) were retrospectively analyzed. The baseline, procedural characteristics, and all outcomes (defined according to Valve Academic Research Consortium-2 criteria) were compared. No significant differences were seen between the dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups with regard to the in-hospital Valve Academic Research Consortium-2 primary end points of major vascular complications (n = 13 [9.4%] vs n = 2 [4.3%]; P = .36), minor vascular complications (n = 13 [9.4%] vs n = 8 [14.7%]; P = .14), major bleeding (n = 16 [11.5%] vs n = 2 [4.3%]; P = .25), and minor bleeding (n = 9 [6.5%] vs n = 5 [10.9%]; P = .34), with higher rates of hematoma in the dual Perclose ProGlide+Angio-Seal group (n = 4 [2.9%] vs n = 5 [10.9%]; P = .044). Finding from the current study suggest that adjunctive Angio-Seal deployment may be feasible and safe, especially in patients with incomplete hemostasis following dual Perclose ProGlide use, and can be an optimal "bailout" procedure.

Dual ProGlide versus ProGlide and FemoSeal for vascular access haemostasis after transcatheter aortic valve implantation.

Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited. We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI. We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria. Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08). A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

How accurate are manufacturers’ recommendations in determining ineligibility for transfemoral transcatheter aortic valve implantation?

IntroductionUp to one-third of patients indicated for transcatheter aortic valve implantation (TAVI) may be unsuitable for transfemoral TAVI (TF-TAVI) according to manufacturers’ recommendations and numerous professional societies. ObjectiveThis study aimed to investigate the predictive value of manufacturers’ guidelines for major vascular access site complications using the Perclose ProGlide device. MethodsAmong 208 patients undergoing TF-TAVI, 144 patients (69.2%) were deemed eligible for TF-TAVI according to the manufacturer's instructions. A minimal lumen diameter (MLD) of the femoral artery below the manufacturer's specified limits and/or the presence of circumferential calcification were the reasons for ineligibility. Calcium score (CS), sheath-to-femoral artery ratio (SFAR) and MLD were estimated from computed tomography imaging. Vascular complications (VCs) (defined according to VARC-2 criteria) were retrospectively compared. ResultsPatients in the ineligible group had higher SFAR (1.13±0.15 vs. 0.88±0.107, p<0.001) and CS (1.66±0.99 vs. 1.24±0.73; p=0.003), and significantly lower MLD (7.72±1.03 vs. 6.31±0.96 mm; p<0.001) compared to the eligible group. Major (6.3% vs. 12.3%, p=0.13) and minor VCs (10.4% vs. 15.6%, p=0.29) were similar in the eligible and ineligible groups. The ineligible group had higher rates of rupture (0.7% vs. 6.3%; p=0.03). SFAR was the only independent predictor of major VCs (OR 469.1, 95% CI 4.95-44466.57, p=0.008). ConclusionThe TAVI team should not decide whether the patient is suitable for a femoral approach based solely on the manufacturer's criteria, and should incorporate additional factors that could be predictive of major VCs.

Incidence of vascular complications for electrophysiology procedures in the ultrasound era: a single-centre experience over 10,000 procedures in the long term.

Ultrasound (US) is being increasingly used to guide vascular access for electrophysiology (EP) procedures in many centres. Nonetheless, the incidence and predictors of vascular complications in the US era are limited. In this study, we describe our experience of vascular access-related complications associated with EP procedures which were performed with the routine use of US-guided vascular access. A total of 10,158 consecutive EP procedures in 8361 patients performed from April 2014 (when our centre moved to a policy of routine US-guided vascular access for EP procedures) to March 2022 were included. The outcome of interest was any vascular access-related complication that occurred within 7days of the procedure; these were classified as severe if surgical intervention and/or blood transfusion was required, major if non-surgical intervention or delayed hospital discharge was required, or minor if it did not fulfil the criteria for severe or major. During the study period, 2 (0.02%) severe vascular complications occurred, including 1 pseudo-aneurysm requiring surgery and 1 retroperitoneal haemorrhage requiring blood transfusion. Nine (0.09%) major complications occurred, including 6 hematomas managed by compression devices, 1 type B aortic dissection, 1 AV fistula managed conservatively and 1 haematoma managed conservatively but delayed hospital discharge. Eighteen (0.18%) minor haematomas were seen that did not require any intervention or delayed hospital discharge. On multivariable analysis, female sex [OR (95% CI): 2.5 (1.2, 5.4)] and use of an arterial access [OR (95% CI): 19.3 (7.1, 52.3)] were seen to be independent predictors of the 29 vascular complications. With the use of US-guided vascular access in EP procedures, major vascular complications are exceedingly rare, particularly those needing surgical intervention. Our results provide additional evidence for scientific guidelines to support US use.

Transcarotid Versus Transfemoral Transcatheter Aortic Valve Replacement (from a Propensity-Matched Comparison)

Previous reports comparing transcarotid (TC) versus transfemoral (TF) approaches for patients undergoing transcatheter aortic valve replacement have had inconsistent conclusions. We compared in-hospital and 1-year clinical outcomes, changes in quality of life, and direct hospital costs for 138 TC versus 1,926 TF procedures. Propensity matching based on the Society of Thoracic Surgery Predicted Risk of Mortality was used to compare 130 patients who underwent TC with 813 patients who underwent TF. Matched TC versus TF cohorts did not differ with respect to in-hospital mortality (0.0% vs 1.4%, p=0.380), stroke (2.3% vs 2.5%, p=0.917), major vascular complications (0.8% vs 2.2%, p=0.268), composite bleeding complications (4.6% vs 6.4%, p=0.647), requirement for permanent pacemaker (14.6% vs 12.9%, p=0.426), postoperative hospital length of stay (3.3 ± 3.4 vs 3.1 ± 3.3 days, p=0.467), or direct hospital costs ($52,899 ± 9,560 vs $50,464 ± 10,997, p=0.230). Similarly, at 1-year, patients who underwent TC versus patients who underwent TF did not differ with respect to all-cause mortality (7.6% vs 6.4%, p=0.659), hospital readmission (20.0% vs 23.9%, p=0.635), or quality of life as measured by the Kansas City Cardiomyopathy Questionnaire score (84.0 ± 17.1 vs 88.4 ± 13.9, p=0.062). Patients who underwent TC and TF did not differ with respect to in-hospital complications, length of hospital stay, and direct hospital costs, as well as 1-year mortality, readmission, and quality of life. These data add to ongoing support for the TC approach as the optimal alternative access for patients with transcatheter aortic valve replacement deferred from a transfemoral approach.

Transcatheter aortic valve replacement with or without anesthesiologist: results from a high-volume single center.

Local instead of general anesthesia has become the standard approach in many centers for transfemoral transcatheter aortic valve replacement (TAVR). New generation devices and an increase in operator skills had led to a drastic reduction in periprocedural complications, bringing in the adoption of a minimalist approach. In our study, we aimed to compare patients treated with TAVR under local anesthesia with or without the presence of an anesthesiologist on site (AOS). We compare procedural aspects and results of patients treated with TAVR with an AOS against patients treated with TAVR with an anesthesiologist on call (AOC). From January 2019 to December 2020, all consecutive patients undergoing transfemoral TAVR with either the self-expandable Evolut (Medtronic, MN, USA) or balloon-expandable SAPIEN 3 (Edwards Lifesciences, CA, USA) were collected. Of 332 patients collected, 96 (29%) were treated with TAVR with AOS, while 236 (71%) were treated with TAVR with AOC. No differences in procedural time, fluoroscopy time and amount of contrast medium were observed. No procedural death and conversion to open-chest surgery was reported. The rate of stroke/transient ischemic attacks and major vascular complications was similar in the two groups. No patients in both groups required conversion to general anesthesia. Two patients (0.8%) in the AOC group required urgent intervention of the anesthesiologist. In the AOC group, there was a greater use of morphine (55.9% vs. 33.3%, P = 0.008), but with a lower dose for each patient (2.0 vs. 2.8 mg, P = 0.006). On the other hand, there was a lower use of other painkiller drugs (3.4% vs. 20.8%, P = 0.001). No difference in inotropic drugs use was observed. In patients at low or intermediate risk undergoing transfemoral TAVR, a safe procedure can be performed under local anesthesia without the presence of an anesthesiologist in the catheterization laboratory.

Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement

BackgroundTranscatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke.MethodsWe randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR.ResultsA total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, −0.6 percentage points; 95% confidence interval, −1.7 to 0.5; P=0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site.ConclusionsAmong patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.)

Early and mid-term outcome of patients with low-flow-low-gradient aortic stenosis treated with newer-generation transcatheter aortic valves.

Patients with non-paradoxical low-flow–low-gradient (LFLG) aortic stenosis (AS) are at increased surgical risk, and thus, they may particularly benefit from transcatheter aortic valve replacement (TAVR). However, data on this issue are still limited and based on the results with older-generation transcatheter heart valves (THVs). The aim of this study was to investigate early and mid-term outcome of TAVR with newer-generation THVs in the setting of LFLG AS. Data for the present analysis were gathered from the OBSERVANT II dataset, a national Italian observational, prospective, multicenter cohort study that enrolled 2,989 consecutive AS patients who underwent TAVR at 30 Italian centers between December 2016 and September 2018, using newer-generation THVs. Overall, 420 patients with LVEF ≤50% and mean aortic gradient <40 mmHg were included in this analysis. The primary outcomes were 1-year all-cause mortality and a combined endpoint including all-cause mortality and hospital readmission due to congestive heart failure (CHF) at 1 year. A risk-adjusted analysis was performed to compare the outcome of LFLG AS patients treated with TAVR (n = 389) with those who underwent surgical aortic valve replacement (SAVR, n = 401) from the OBSERVANT I study. Patients with LFLG AS undergoing TAVR were old (mean age, 80.8 ± 6.7 years) and with increased operative risk (mean EuroSCORE II, 11.5 ± 10.2%). VARC-3 device success was 83.3% with 7.6% of moderate/severe paravalvular leak. Thirty-day mortality was 3.1%. One-year all-cause mortality was 17.4%, and the composite endpoint was 34.8%. Chronic obstructive pulmonary disease (HR 1.78) and EuroSCORE II (HR 1.02) were independent predictors of 1-year mortality, while diabetes (HR 1.53) and class NYHA IV (HR 2.38) were independent predictors of 1-year mortality or CHF. Compared with LFLG AS treated with SAVR, TAVR patients had a higher rate of major vascular complications and permanent pacemaker, while SAVR patients underwent more frequently to blood transfusion, cardiogenic shock, AKI, and MI. However, 30-day and 1-year outcomes were similar between groups. Patients with non-paradoxical LFLG AS treated by TAVR were older and with higher surgical risk compared with SAVR patients. Notwithstanding, TAVR was safe and effective with a similar outcome to SAVR at both early and mid-term.

Major vascular complications are reduced by ultrasound guided venous puncture compared to conventional technique in cardiac catheter ablation: a meta-analysis

Abstract Background Puncture site vascular complications are relatively common during invasive electrophysiology. One of the most promising measures to minimize these adverse events is the use of vascular ultrasound during puncture. Objective We aimed to carry out a meta-analysis comparing conventional, anatomically guided femoral venous puncture to ultrasound-guided puncture during electrophysiology procedures, which, in contrast to, the previous meta-analyses, used a uniform endpoint and involved novel trials resulting in higher patients numbers. Methods We conducted a systematic search in relevant electronic databases for articles reporting the rate of vascular complications during EP procedures both with and without ultrasound guidance. We defined major vascular complications (MVCs, as defined in the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus) as the primary endpoint. Secondary endpoints were arteriovenous fistula, pseudoanerurysm and major bleeding separately, and minor vascular complications and accidental arterial punctures. Statistical analysis was performed using a random effect model with the Mantel-Haenszel method. Results A total of 23605 patients were included in the 14 articles matching our selection criteria, and there were data on the primary outcome in 15160 of them (in 11 articles), with 236 (1.6%), who reached the primary endpoint of an MVC. Routine application of ultrasound guidance significantly reduced the incidence of major vascular complications (42/5645 vs. 194/9515, OR 0.36 [0.23–0.55], p&amp;lt;0.001). Furthermore, we found significantly lower incidence in several of our secondary endpoints: for total vascular complications the OR was 0.27 [0.13–0.53] (p&amp;lt;0.001), for major bleedings the OR was 0.42 [0.24–0.74] and for inadvertent artery puncture the OR was 0.24 [0.15–0.38] (p&amp;lt;0.001). Data was insufficiently reported in respect of arteriovenous fistulae and of pseudoanerurysms specifically. Conclusion With more than double of the number of patients compared to the previous meta-analyses, and with a more consistent MVC definition, we showed that ultrasound guidance for femoral venous puncture has significant benefits, most importantly reduces the incidence of major vascular complications and total vascular complications. Our results underscore the need for a randomized controlled trial in the question, with potentially important implications for daily clinical practice and patient safety. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Project no. NVKP_16-1–2016-0017 (“National Heart Program”) has been implemented with the support provided by the Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund of Hungary, financed under the NVKP_16 funding scheme. -Project no. MEC_R-141548 has been implemented with the support provided by the Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund, financed under the MEC_R_21 funding scheme.

Large multicenter evaluation of clinical outcomes of transcatheter aortic valve implantation in different age groups: results from the Israeli TAVI registry

Abstract Introduction Transcatheter aortic valve implantation (TAVI) is becoming the preferred treatment for elderly patients with severe aortic stenosis. Clinical outcomes of these patients according to different age groups and especially in the very old population are under reported. Purpose To describe clinical characteristics at baseline, according to different age groups, and to compare clinical outcomes in the very old population with other patients undergoing the procedure. Methods Data was extracted from the Israeli National TAVI Registry. Clinical outcomes in very old patients (above the age of 90 years) were compared with younger patients. Multivariable analysis for 30-day and 1-year mortality were performed. Procedural complication was defined as one or more of the following: need for permanent pacemaker, major vascular complication, severe acute kidney injury and major stroke. Results A total of 5,936 patients who underwent TAVI from 2008 to 2021 were analyzed (age 81.6±7.1 years, 50.6% female). Patients older than 90 years of age had more comorbidities than the younger population (STS score for mortality 6.4%±3.8% vs. 4.1%±4.8%, p&amp;lt;0.001). Independent correlates for 30-day mortality included STS score (OR=1.01, 95% CI [1.03–1.13], p&amp;lt;0.001) and procedural complication (OR=4.29, 95% CI [2.24–8.20], p&amp;lt;0.0001). Independent correlates for 1-year mortality included chronic obstructive pulmonary disease (OR=1.83, 95% CI [1.28–2.60]; p=0.001), atrial fibrillation (OR=1.71, 95% CI [1.31–2.23]; p&amp;lt;0.001 (STS score); OR=1.13 95% CI [1.09–1.18]; p&amp;lt;0.001), and procedural complication) OR=2.58, 95% [1.89–3.50]; p&amp;lt;0.001). Conclusions Although older patients undergoing TAVI had a higher risk profile, short- and long-term survival of these patients were associated significantly more with procedural complications than with patient age. It seems that extreme patient age alone should not be viewed as a consideration for not performing valve replacement, as long as the risk for procedural complications does not seem to be severely elevated. Funding Acknowledgement Type of funding sources: None.