In-hospital Vascular Complications Research Articles

Safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with previous TAVI; a systematic review and meta-analysis

Abstract Background Transcatheter Aortic Valve Implantation (TAVI) has gained ground in the management of severe aortic stenosis, even in low-surgical risk patients. However, TAVI prostheses, like bioprostheses, have a finite lifetime; thus, TAVI in patients with previous TAVI (TAVI-in-TAVI) rates are radically increased. Although data regarding TAVI indicate low mortality and stroke rates within the first year, TAVI-in-TAVI is less studied. Purpose The aim of the study is to systematically review and summarize available data regarding the safety and the outcomes of TAVI-in-TAVI. Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 10, 2024, for studies assessing the characteristics and outcomes of patients undergoing TAVI-in-TAVI. Primary endpoint of our systematic review and meta-analysis is the in-hospital, 30-days and 1-year mortality rates. Secondary endpoints comprised in-hospital, 30-days and 1-year stroke rates, in-hospital vascular complications, conversion to surgery, coronary compression or obstruction, and perforation with or without tamponade, and in-hospital and 30-days permanent pacemaker implantation (PPM) implantation. Endpoint definitions followed the Valve Academic Research Consortium 3 criteria. The cumulative incidence of primary and secondary endpoints and the corresponding 95% confidence intervals (CI) were estimated. A random effects model (DerSimonian-Laird) was used to account for heterogeneity among the included studies. Results Our meta-analysis included a total of 5 studies and 2,145 patients undergoing TAVI-in-TAVI, 72.9% (N=1,564) of whom were treated with a balloon-expandable valve. Our analysis showed that patients undergoing TAVI-in-TAVI had 3.7% (95% CI: 1.6%-5.9%), 3.9% (95% CI: 3%-4.7%) and 12.5% (95% CI: 11%-14%) in-hospital, 30-days and 1-year all-cause mortality, while stroke occurred in 1.8% (95% CI: 1.2%-2.4%), 2.1% (95% CI: 1.4%-2.9%) and 3% (95% CI: 2.3%-3.8%) of the patients in-hospital, 30-days and 1-year, respectively. Notalby, conversion to surgery, coronary compression/obstruction and perforation with or without tamponade occurred in <1% of the patients, while 6.1% (95% CI: 2.2%-9.9%) of the patients had vascular complications during the procedure. Considering the PPM implantation rates, patients had a 1.8% (95% CI: 1.2%-2.4%) for in-hospital and a 6.8% (95% CI: 5.2%-8.3%) for 30-days incidence. Conclusion Our systematic review and meta-analysis is the first to present that TAVI-in-TAVI has an acceptable safety profile with relatively low in-hospital, 30-days and 1-year mortality and stroke rates, comparable to the native-valve-TAVI. Taking into consideration that TAVI-in-TAVI might be the only therapeutic approach for an increasing number of patients, further studies are warranted to further assess its safety and efficacy and to provide additional procedural techniques.TAVI-in-TAVI mortality rates

Impacto del sexo en los resultados hospitalarios y a largo plazo tras el implante percutáneo de válvula aórtica: un análisis del registro español de TAVI

Introduction and objectivesImpact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. MethodsThis analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. ResultsThe study included 12 253 consecutive TAVI patients with a mean age of 81.2±6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0±7.0 vs 6.2±6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P <.001) and cardiac tamponade (1.5% vs 0.6%; P=.009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P=.009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted OR, 1.01; 95%CI, 0.83-1.23; P=.902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P=.564) or at 1 year (11% vs 13%, adjusted HR, 0.94; 95%CI, 0.80-1.11; P=.60). ConclusionsWomen treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

Impact of gender on in-hospital and long-term outcomes after transcatheter aortic valve implantation: an analysis of the Spanish TAVI registry

Introduction and objectivesImpact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. MethodsThis analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. ResultsThe study included 12 253 consecutive TAVI patients with a mean age of 81.2±6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0±7.0 vs 6.2±6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P <.001) and cardiac tamponade (1.5% vs 0.6%; P=.009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P=.009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted OR, 1.01; 95%CI, 0.83-1.23; P=.902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P=.564) or at 1 year (11% vs 13%, adjusted HR, 0.94; 95%CI, 0.80-1.11; P=.60). ConclusionsWomen treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

Vascular Complications in Transcatheter Aortic Valve Replacement With Plug-Based vs Suture-Based Closure Devices.

There are conflicting data regarding the efficacy and safety of suture vs plug-based vascular closure devices (VCDs) for large-bore catheter management in patients undergoing transcatheter aortic valve replacement (TAVR). We compared the rates of vascular complications (VCs) associated with 2 commonly used VCDs in a large cohort of patients undergoing TAVR. We conducted a single-centre, all-comer, prospective registry study, enrolling patients undergoing TAVR for symptomatic severe aortic stenosis (AS) between the years 2009 and 2022. Clinical outcomes were compared between patients undergoing closure of the femoral access point using the MANTA VCD (M-VCD) (Teleflex, Wayne, PA) vs the ProGlide VCD (P-VCD) (Abbott Vascular, Abbott Park, IL). The main outcome measures were researcher adjudicated events of VARC-2 defined major and minor VCs. Overall, 2368 patients were enrolled in the registry; 1315 (51.0% male, 81.0 ± 7.0 years) patients were included in the current analysis. P-VCD was used in 813 patients, whereas M-VCD was used in 502 patients. In-hospital VCs were more frequent in the M-VCD vs the P-VCD group (17.3% vs 9.8%; P < 0.001). This outcome was mainly driven by elevated rates of minor VCs in the M-VCD group, whereas no significant difference was observed for major VCs (15.1% vs 8.4%; P < 0.001 and 2.2% vs 1.5%; P= 0.33, respectively). In patients undergoing TAVR for severe AS, M-VCD was associated with higher rates of VCs. This outcome was mainly driven by minor VCs. The rate of major VCs was low in both groups.

How brachial access compares to femoral access for invasive cardiac angiography when radial access is not feasible: A meta-analysis.

Trans-radial access is considered the best approach for cardiac catheterization. The choice of an alternative access route may be complex and trans-femoral access (TFA) is generally preferred. However, trans-brachial approach (TBA) may represent another feasible alternative. We therefore aimed to compare TBA and TFA in terms of access site bleeding and complications in a meta-analysis study. We systematically searched principal databases for studies comparing femoral and brachial approach in terms of in-hospital vascular complications in patients undergoing cardiac catheterization (coronary angiography or percutaneous coronary intervention). Five retrospective studies and one randomized study were identified for the meta-analysis; 2756 patients undergoing a TBA and 331.208 patients undergoing a TFA for cardiac catheterization were included in the final study. No significant differences between access routes were found in terms of risk of any vascular complications (relative risk 1.18; 95% CI: 0.91-1.53; p n.s.). Brachial access was associated with a significantly lower risk of access site bleeding (relative risk 0.46; 95% CI 0.24-0.88, p = 0.02). TBA for cardiac catheterization was associated with a lower risk of access site bleeding and a comparable risk of any vascular complications compared with TFA. TBA may be considered a reasonable alternative access route for cardiac catheterization, at least as femoral approach.

Transcatheter versus surgical aortic valve replacement for stenotic bicuspid aortic valve: Systematic review and meta-analysis

ObjectivesBicuspid aortic valves have been excluded from randomized trials comparing transcatheter aortic valve replacement with surgical aortic valve replacement. We aimed to evaluate the outcomes of transcatheter aortic valve replacement versus surgical aortic valve replacement in patients with severe bicuspid aortic valve stenosis using a meta-analysis. MethodsMEDLINE and EMBASE were searched through March 2022 to identify observational studies comparing transcatheter aortic valve replacement and surgical aortic valve replacement for severe bicuspid aortic valve stenosis. Outcomes of interest were in-hospital outcomes, including all-cause mortality, stroke, vascular complication, permanent pacemaker implantation, acute kidney injury, blood transfusion, paravalvular leak, and all-cause mortality during follow-up. ResultsFour propensity score–matched studies and 54,047 patients (transcatheter aortic valve replacement, n = 3841; surgical aortic valve replacement, n = 50,206) yielding 3142 pairs using propensity score were included. Median follow-up periods were 21 to 24 months. There were no significant differences in in-hospital mortality (risk ratio, 0.69; 95% confidence interval, 0.40-1.20; P = .19) or stroke (risk ratio, 0.86; 95% confidence interval, 0.64-1.14; P = .29). Although transcatheter aortic valve replacement was associated with higher risks of permanent pacemaker implantation rate (risk ratio, 1.87; 95% confidence interval, 1.23-2.84; P = .0003), transcatheter aortic valve replacement was associated with lower risks of acute kidney injury (risk ratio, 0.58; 95% confidence interval, 0.38-0.88; P = .01) and transfusion (risk ratio, 0.25; 95% confidence interval, 0.21-0.29; P = .0001). There were no significant differences in in-hospital vascular complication, paravalvular leak, and all-cause mortality during follow-up. ConclusionsIn selected patients with severe bicuspid aortic valve stenosis, no significant differences in in-hospital mortality or stroke were observed between transcatheter aortic valve replacement and surgical aortic valve replacement. Further investigations with long-term follow-up and morphological features are warranted.

Transcatheter aortic valve replacement in obese patients: procedural vascular complications with the trans-femoral and trans-carotid access routes.

OBJECTIVESObesity may increase the risk of vascular complications in transfemoral (TF) transcatheter aortic valve replacement (TAVR) procedures. The transcarotid (TC) approach has recently emerged as an alternative access in TAVR. We sought to compare vascular complications and early clinical outcomes in obese patients undergoing TAVR either by TF or TC vascular access.METHODSMulticentre registry including obese patients undergoing TF- or TC-TAVR in 15 tertiary centres. All patients received newer-generation transcatheter heart valves. For patients exhibiting unfavourable ileo-femoral anatomic characteristics, the TC approach was favoured in 3 centres with experience with it. A propensity score analysis was performed for overcoming unbalanced baseline covariates. The primary end point was the occurrence of in-hospital vascular complications (Valve Academic Research Consortium-2 criteria).RESULTSA total of 539 patients were included, 454 (84.2%) and 85 (15.8%) had a TF and TC access, respectively. In the propensity-adjusted cohort (TF: 442 patients; TC: 85 patients), both baseline and procedural valve-related characteristics were well-balanced between groups. A significant decrease in vascular complications was observed in the TC group (3.5% vs 12% in the TF group, odds ratio: 0.26, 95% CI: 0.07–0.95, P = 0.037). There were no statistically significant differences between groups regarding in-hospital mortality (TC: 2.8%, TF: 1.5%), stroke (TC: 1.2%, TF: 0.4%) and life-threatening/major bleeding events (TC: 2.8%, TF: 3.8%).CONCLUSIONSIn patients with obesity undergoing TAVR with newer-generation devices, the TC access was associated with a lower rate of vascular complications. Larger randomized studies are warranted to further assess the better approach for TAVR in obese patients.

B-PO02-154 FIGURE OF EIGHT SUTURES IN FULLY ANTICOAGULATED PATIENTS AFTER LEFT ATRIAL APPENDAGE OCCLUSION MAY OBVIATE NEED FOR ANTICOAGULATION REVERSAL

There are limited data regarding vascular access site management after left atrial appendage occlusion (LAAO). Intravenous protamine is widely used to reverse anticoagulation but has potential for serious adverse reactions including anaphylaxis, thrombosis, and stroke. To evaluate the safety and effectiveness of a single figure-of-eight suture in securing hemostasis after LAAO. 112 consecutive patients who underwent LAAO with a Watchman device between 2016 and 2020 were included. Ultrasound-guided, right femoral venous access was obtained. IV heparin bolus was given prior to trans-septal access targeting ACT >350 seconds. At the end of the case, a subcutaneous figure-of-eight suture was applied and watchman delivery sheath removed without reversal with protamine. Patients laid flat for 6 hours and figure of 8 sutures were removed the following day (figure 1). We evaluated the rates of in-hospital vascular complications with our protocol Mean age was 75 (8.5) yr, 52 (46%) women, 106 (95%) Caucasian, 67 (60%) had paroxysmal atrial fibrillation. Mean hemoglobin was 12.7 (2) mg/dl, creatinine 1.2 (0.9) mg/dl, platelet count was 205k (61k). 18 (16%) were on uninterrupted antiplatelet drug, 52 (46%) were on warfarin with mean INR 2.5 (0.5), 60 (54%) were on a direct oral anticoagulant. 1 patient had retroperitoneal hematoma which was conservatively managed. There were no significant hematomas, pseudoaneurysms or AV fistulas. In anticoagulated patients undergoing LAAO, hemostasis was obtained with figure-of-eight sutures with low rate of vascular complications without the need for anticoagulation reversal.

Rates, predictors and the impact of cannabis misuse on in-hospital outcomes among patients undergoing percutaneous coronary intervention (from the National Inpatient Sample).

Whether cannabis use worsens outcomes in coronary heart disease is unknown and no previous study has evaluated the outcomes for patients who undergo percutaneous coronary intervention (PCI) according to cannabis use. We analysed patients in the National Inpatient Sample between 2004 and 2014 who underwent PCI and evaluated rates, predictors and outcomes of patients according to cannabis misuse defined by cannabis abuse or dependence. A total of 7306012 patients were included and 32765 cannabis misusers (0.4%). Cannabis misusers were younger (49.5 vs 64.6years, P<.001) and were more likely to be male (82.7% vs 66.3%, P<.001). There was also a greater proportion of patients who were of black ethnicity in the cannabis misuse group (27.7% vs 7.9%, P<.001) and fewer elective admissions (7.8% vs 27.6%, P<.001). There was no difference in in-hospital mortality (OR 1.06 95% CI 0.80-1.40, P=.67), bleeding (OR 0.94 95% CI 0.77-1.15, P=.55) and stroke/transient ischaemic attack (OR 1.19 95% CI 0.98-1.45, P=.084) compared with non-cannabis misusers. Cannabis misusers had significantly lower odds of in-hospital vascular complications (OR 0.73 95% CI 0.58-0.90, P=.004). Our results suggest that cannabis misusers are more likely to be male, of black ethnicity and from the lowest quartile of income, but there was no evidence that cannabis misuse is associated with worse periprocedural outcomes following PCI when controlling for key proxies of health status.

Percutaneous nitinol-based vascular closure device for large bore arterial access hemostasis: Results of a prospective multicenter study.

Vascular complications during transcatheter aortic valve replacement (TAVR) still pose a significant concern regarding procedural safety. Designated closure devices for large-bore vascular access are needed. Patients undergoing TAVR were prospectively enrolled into the study. The InSeal vascular closure device (VCD) achieves hemostasis by utilizing a crescent-shaped nitinol scaffold covered by a biodegradable membrane, which is delivered at the arterial puncture site. The coprimary endpoints were predefined as hemostasis within 15 min following vessel access site closure and after activated clotting time falls below 200 s and the rate of related major vascular adverse events in first month. A total of 50 patients were prospectively enrolled into the study, with an average age of 80.8 ± 7.4 years and 62% males. Hemostasis with the Inseal VCD was achieved in 94% of the patients with average time-to-hemostasis of 51 ± 97 s. The rates of in-hospital vascular complications were 12% mostly driven by minor vascular complications (10%). Femoral artery stents were used in three patients due to failed hemostasis. Initial clinical experience indicates that a novel, nitinol-based, large-bore vascular closure device is safe and effective in achieving hemostasis after TAVR.

Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

Vascular and bleeding complications were commonly reported in transcatheter aortic valve replacement clinical trials. Little is known about complication rates in contemporary US clinical practice or clinical outcomes associated with these complications. In the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we evaluated patients undergoing transcatheter aortic valve replacement from November 1, 2011 to June 30, 2016. The primary outcomes were in-hospital vascular complications and bleeding events. Secondary outcomes included all-cause mortality, stroke, and rehospitalization at 1 year. P values for trends were calculated for rates over time, and multivariable logistic regression was used to determine the association between vascular/bleeding complications and in-hospital clinical outcomes. Overall, 34 893 patients undergoing transcatheter aortic valve replacement at 445 hospitals were analyzed. Of these, 9.3% (n=3257) experienced a vascular complication while 7.6% (n=2651) had an in-hospital bleeding event. Rates of both vascular complications and bleeding events decreased over time (P value for trend test <0.0001); however, there was significant variation in rates across hospital sites (adjusted median rate, 11.4%; IQR, 8.9-14.5). Vascular complications were independently associated with 30-day death (adjusted HR, 2.23 [95% CI, 1.80-2.77]) and death (adjusted HR, 1.17 [95% CI, 1.05-1.30]) and rehospitalization (adjusted HR, 1.14 [95% CI, 1.07-1.22]) at 1 year. Bleeding events were also associated with 30-day death (adjusted HR, 3.71 [95% CI, 2.94-4.69]), and with death (adjusted HR, 1.39 [95% CI, 1.23-1.56]) and hospital readmission (adjusted HR, 1.19 [95% CI, 1.11-1.27]) at 1 year. In patients undergoing transcatheter aortic valve replacement in the US, vascular complications and in-hospital bleeding events were common, but rates have declined over time with significant variation in complication rates across hospital sites. Vascular and bleeding complications are both associated with worse short- and long-term clinical outcomes including all-cause mortality. Further innovation to reduce sheath sizes and optimize antithrombotic therapy is necessary to reduce the incidence of these detrimental complications.

P6510Frailty and in-hospital outcomes in percutaneous coronary interventions

Abstract Background Frailty may be an important marker for poor outcomes in percutaneous coronary intervention (PCI) and there is limited literature on outcomes based on frailty from national cohorts. Purpose This study evaluates the prevalence of frailty, changes in frailty over time and outcomes associated with frailty in a national American cohort of patients who underwent PCI. Methods The study included adults who underwent PCI in the National Inpatients Sample between 2004 and 2014. Frailty risk was determined using a validated Hospital Frailty Risk Score (HFRS) using the cutoffs &lt;5, 5–15 and &gt;15 corresponding to low, intermediate and high HFRS. Results There were 7,306,007 PCI admissions in this cohort. A total of 94.58%, 5.39% and 0.03% of admissions were for low HFRS, intermediate HFRS and high HFRS, respectively. The proportion of intermediate or high frailty risk patients increased over time from 1.9% in 2004 to 11.7% in 2014. In-hospital death increased from 1.0% with low HFRS to 13.9% with high HFRS and average length of stay increased from 2.9±3.3 days to 17.1±15.5 days from low to high HFRS. Greater frailty risk was associated with greater average inpatient cost which was $17,743±11,059, $38,824±34,809 and $56,119±49,772 for low, intermediate and high HFRS, respectively. There were increased adverse outcomes with high frailty including greater in-hospital death (OR 9.91 95% CI 7.17–13.71), in-hospital bleeding complications (OR 4.99 95% CI 3.82–6.51), in-hospital vascular complications (OR 3.96 95% CI 3.00–5.23) and in-hospital stroke (OR 10.49 95% CI 8.28–13.29) comparing high to low HFRS. Conclusions More than 1 in 20 patients who undergo PCI have intermediate or high risk of frailty which has significantly increased over time. There are poor outcomes and increased inpatient costs associated with greater frailty. Improvements in education of healthcare workers and increased awareness of frailty could facilitate frailty-tailored care to minimise risk of adverse outcomes and its associated costs. Acknowledgement/Funding Research and Development Department at the Royal Stoke Hospital, Keele University and Biosensors International

Comparison of Baseline Characteristics and Outcomes in Men Versus Women With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Female gender has been linked to increased risk of adverse events after surgical aortic valve replacement; however, the evidence regarding the role of gender differences on clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI) is still debated. This retrospective study included 910 consecutive patients with severe, symptomatic aortic stenosis who underwent TAVI in 2 institutions from January 2012 to July 2016. The primary end point was all-cause mortality at 1 year after TAVI in women versus men. Women had a higher incidence of in-hospital vascular complications (7.8% vs 4.1%) and major or life-threatening bleeding (4.0% vs 1.6%) than men. At 1 year, women showed a lower mortality rate than men (7.0% vs 12.7%, adjusted hazard ratio [HR] 0.42, 95% confidence interval [CI] [0.23 to 0.76], p = 0.004). When stratifying by specific subgroups of interest, the survival benefit in women persisted in (1) patients with a Society of Thoracic Surgery risk score ≤ 8 (adjusted HR 0.35, 95% CI [0.14 to 0.88], p = 0.026); (2) patients treated with first-generation devices (adjusted HR 0.46, 95% CI [0.24 to 0.86], p = 0.016); and (3) patients treated with balloon-expandable valves (adjusted HR 0.40, 95% CI [0.19 to 0.86], p = 0.019). In conclusion, in this large patient cohort, women had lower 1-year mortality after TAVI than men, particularly with an STS score ≤ 8, or treated with first-generation and balloon-expandable devices.

Ankle-brachial pressure index as a predictor of the 2-year outcome after transcatheter aortic valve replacement: data from the Japanese OCEAN-TAVI Registry.

Peripheral artery disease plays a pivotal role for access site selection in transcatheter aortic valve replacement (TAVR). Abnormal ankle-brachial index (ABI) is a generalized mortality marker in many cardiovascular scenarios. However, the long-term outcomes in high-risk TAVR populations remain unclear. We investigated the association between low ABI and 2-year outcome after TAVR. Of 1613 patients enrolled in the OCEAN-TAVI registry, 1458 (90.4%) who underwent ABI before TAVR were divided into groups: patients with (1) ABI≥0.9 in both legs and (2) ABI<0.9 in either leg. Primary endpoint was all-cause death within 2years. ABI<0.9 was noted in 304 patients (20.8%). ABI<0.9-group had more frequent and severe comorbidities. Primary endpoint in ABI<0.9-group was significantly higher than that in ABI≥0.9-group (15.8 vs. 8.7%, p<0.001). This trend continued in the transfemoral (TF)-approach (14.9 vs. 7.5%, p<0.001), but not in the alternative approach (17.2 vs. 15.8%, p=0.815). Within 30days, ABI<0.9-group had a higher cardiac death rate (3.1 vs. 1.0%, p=0.033), whereas between 31days and 2years, non-cardiovascular death was more frequently observed (9.2 vs. 5.1%, p=0.003). In ABI<0.9-group, in-hospital vascular complications (11.9 vs. 4.9%, p<0.001) and acute kidney injury (10.8 vs, 5.7%, p=0.009) were more frequently found when using the transfemoral-approach. In multivariate analysis, ABI<0.9 was an independent predictor of 2-year mortality (adjusted hazard ratio 1.495, 95% CI 1.007-2.220, p=0.046). Pre-procedure ABI<0.9 is a useful prognostic marker for all-cause mortality, even in high-risk TAVR populations.

Sex-Based Differences in Outcomes With Transcatheter Aortic Valve Therapy: TVT Registry From 2011 to 2014

BackgroundA differential impact of sex has been observed in transcatheter aortic valve replacement (TAVR) outcomes from small observational studies and subgroup analyses of randomized trials. ObjectivesThe goal of this study was to compare the in-hospital and 1-year outcomes in male and female subjects from the U.S. nationwide TAVR registry. MethodsNational data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were used for in-hospital outcomes, and data linked from the Centers for Medicare & Medicaid Services were used to provide 1-year events. Multivariable logistic regression adjustment was performed for in-hospital outcomes. Fine-Gray models were used for nonfatal 1-year outcomes to account for the competing risk of death. ResultsFrom 2011 to 2014, a total of 11,808 (49.9%) women and 11,844 (51.1%) men underwent TAVR. Compared with male patients, female patients were older, with a lower prevalence of coronary artery disease, atrial fibrillation, and diabetes but a higher rate of porcelain aorta, lower glomerular filtration rate, and higher mean Society of Thoracic Surgeons score (9.0% vs. 8.0%; all p < 0.001). Women were treated more often by using nontransfemoral access than men (45.0% vs. 34.0%). Despite using smaller device sizes, women achieved valve cover index ≥8% more often than men (66% vs. 54%). In-hospital vascular complications were higher in women (8.27% vs. 4.39%; adjusted hazard ratio [HR]: 1.70; 95% CI: 1.34 to 2.14; p < 0.001) and a trend toward higher bleeding (8.01% vs 5.96%; adjusted HR: 1.19; 95% CI: 0.99 to 1.44; p = 0.06) was observed; however, 1-year mortality was lower (21.3% vs. 24.5%; adjusted HR: 0.73; 95% CI: 0.63 to 0.85; p < 0.001) in women than in men. ConclusionsFemale patients undergoing TAVR had a different risk profile compared with male patients. Notwithstanding a greater adjusted risk for in-hospital vascular complications, 1-year adjusted survival was superior in female patients.

Surgical Versus Percutaneous Femoral Access for Delivery of Large-Bore Cardiovascular Devices (from the PARTNER Trial)

It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p= 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p= 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p= 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.

Angioplasty and Provisional Stent Treatment of Common Femoral Artery Lesions

PurposeIsolated atherosclerotic common femoral artery (CFA) disease is a rare cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice, little is known about outcomes of percutaneous treatment. Materials and MethodsA prospectively maintained single-center database was retrospectively analyzed for outcomes of consecutive patients undergoing isolated percutaneous revascularization of CFA disease between 1996 and 2007. In all cases, the intended strategy was balloon angioplasty with provisional stent placement in case of poor angioplasty results. Among 516 consecutive procedures involving the CFA, 419 were excluded because of nonatherosclerotic disease (n = 156) or treatment of additional vascular segments during the same procedure (n = 263). Procedural success (ie,<30% residual stenosis), in-hospital vascular complications (major [requiring surgical or percutaneous treatment] or minor [treated conservatively]), and 12-month restenosis and target lesion revascularization (TLR) rates were assessed for the remaining 97 interventions. ResultsCFA bifurcation lesions were present in 40 cases (41.2%) and required treatment of the deep femoral artery in 25 (25.8%). Chronic total CFA occlusions accounted for 11 cases (11.3%). Balloon angioplasty was performed in 96 cases (98.9%), and provisional stent placement was necessary in 37 (38.1%). The procedure was successful in 89 cases (91.8%). Minor and major vascular complications at 30 days occurred in three (3.1%) and four (4.1%) cases, respectively. At 12 months, restenosis greater than 50% and TLR were observed in 19.5% and 14.1% of procedures, respectively. ConclusionsThis series shows that isolated CFA lesions may be safely and efficaciously treated with angioplasty and provisional stent placement.

Percutaneous left ventricular support for high-risk PCI and cardiogenic shock: who gets what?

Temporary use of a percutaneous left ventricular assist device (PLVAD) may be beneficial in patients undergoing high-risk percutaneous coronary intervention (PCI) and those with cardiogenic shock (CS). Seventy-four consecutive patients undergoing high-risk PCI and those with CS receiving intraaortic balloon pump (IABP), TandemHeart (TH), or Impella device (IMP) were enrolled. Patient undergoing high-risk PCI (n=57) and those treated for CS (n=17) were analyzed as separate cohorts. Patients undergoing IABP-assisted PCI were compared to those undergoing PLVAD (TH and IMP)-assisted PCI. The primary end point was in-hospital major adverse cardiovascular events, and the secondary end point was in-hospital vascular complications. For the high-risk PCI cohort (n=57), 22 received PLVAD and 35 received IABP. Patients receiving IABP were younger and less likely to have a prior myocardial infarction (MI) and less likely to be on dialysis compared to those receiving PLVAD support. Patients receiving PLVAD support had a higher baseline Syntax score, had a higher prevalence of unprotected left main disease, underwent treatment of more coronary lesions, received more coronary stents, and more likely received drug-eluting stents compared to those receiving IABP support. The primary and secondary end points were similar between both groups. For the CS cohort (n=17), 4 received PLVAD and 13 received IABP. Patients receiving PLVAD support were more likely to have a prior MI, had a lower ejection fraction, underwent treatment of more coronary lesions, and received more coronary stents compared to those receiving IABP support. The primary and secondary end points were similar between both groups. IABP compared with PLVAD use for high-risk PCI and CS is associated with significantly different baseline patient, clinical, procedural, and angiographic characteristics. In-hospital clinical outcome was similar between both groups in both the high-risk PCI and the CS cohorts. When physicians have access to each of these devices, short-term clinical outcome appears to be similar.

Safety evaluation of vascular closure devices in femoral artery access

ObjectiveThe aim of the study was to evaluate the in-hospital and long term safety performance of vascular closure devices (VCDs) in femoral artery access.MethodsOne thousand and seventy eight patients who...

The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization

This study aimed at exploring access site-related vascular complication rates associated with the use of the vascular closure device (VCD) Angio-Seal™ in an unselected patient population undergoing elective as well as emergency coronary angiography or intervention. The VCD Angio-Seal™ is widely used to achieve hemostasis after diagnostic and interventional cardiac procedures. There are only little data on the frequency of vascular complications after the use of the VCD Angio-Seal™ in patients in non-elective settings. In-hospital vascular complications were prospectively assessed in 4,653 consecutive cardiac catheterization procedures, which included 2,772 elective diagnostic and 960 elective percutaneous coronary interventions (PCI), and 921 emergency cardiac catheterizations in patients with NSTEMI/STEMI. In 2,077 procedures manual compression (MC) and in 2,576 procedures VCD was applied. Complication rates for manual compression and VCD use were studied and multivariate analyses performed to disclose predictors for access site-related vascular complications. Vascular complication rates in patients receiving MC to achieve hemostasis were similar to those receiving a VCD (MC 3.4% vs. VCD 3.2%, p=n.s.). Separate analysis of vascular complication rates for subgroups revealed a significant reduction in vascular complications for the PCI group using a VCD (MC 7.7% vs. VCD 3.2%, p=0.003). In emergencies VCD use lead to a rise in vascular complications (MC 0.9% vs. VCD 6.3%, p<0.001). In contrast to elective settings, the risk of access site-related vascular complications is significantly increased after application of the VCD Angio-Seal™ in patients undergoing emergency catheterizations for NSTEMI/STEMI compared with manual compression.