Periprocedural Safety Research Articles

Left atrial appendage closure using WATCHMAN device in chronic kidney disease and end-stage renal disease patients.

Chronic kidney disease (CKD) and end-stage renal disease are considered independent risk factors for developing atrial fibrillation (AF). Percutaneous occlusion of left atrial appendage (LAAC) using WATCHMAN device is a widely accepted alternative to anticoagulation therapy to prevent ischemic stroke in AF in patients who are not candidates for anticoagulation. There is limited data regarding the utilization and periprocedural safety of this intervention in patients with CKD/ESRD. We retrospectively reviewed all hospitalizations from 2016 to 2017 with (ICD-10) procedure diagnosis code of LAA closure using WATCHMAN procedure with and without a secondary diagnosis of CKD/ESRD in acute-care hospitals across the United States using the national inpatient sample. Demographic variables (gender, race, income, hospital characteristics, medical comorbidities) were collected and compared. The primary outcomes were inpatient mortality, hospital length, and cost of stay. There were over 71 million discharges included in the combined 2016 and 2017 NIS database. Sixteen thousand five hundred five hospitalizations were for adult patients with a procedure code for LAA closure via watchman procedure. Of 16,505 patients, 3245 (19.66%) had CKD and ESRD. There was no statistically significant difference in mortality, length, and cost of stay in patients with and without CKD/ESRD. There were no statistically significant differences in periprocedural cerebrovascular accidents in both groups. Patients with and without ESRD/CKD who undergo LAA occlusion with Watchman have similar procedure related, in-hospital mortality, and complications.

Procedural and short-term follow-up outcomes of Amplatzer Amulet occluder versus Watchman FLX device: A meta-analysis.

Procedural and short-term follow-up outcomes of Amplatzer Amulet occluder versus Watchman FLX device: A meta-analysis.

Novel cryoballoon system for pulmonary vein isolation: multicenter assessment of efficacy and safety - The ANTARCTICA study

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulmonary vein isolation (PVI) either by balloon devices or point by point radiofrequency (RF) and 3D mapping based catheter ablation forms the cornerstone of invasive atrial fibrillation (AF) treatment and has demonstrated high procedural success and encouraging long-term outcomes. Although equally effective cryoballoon (CB) based PVI offers shorter procedure duration as well as lower complication rates compared to RF based PVI. Beside the worldwide established Arctic Front Advance (AFA) cryoablation system a novel CB ablation system, POLARx was recently introduced. The POLARx CB incorporates unique features which may translate into improved efficacy and safety of CB based PVI. However, multicenter assessment of periprocedural efficacy and safety is lacking up to date. Methods From August 5th to october 12th 2020, a total of 317 patients with paroxysmal or persistent atrial fibrillation (AF) underwent POLARx CB based PVI in 5 centers from Germany and Italy. Acute efficacy and safety were assessed. Results In 317 patients (mean age 64±12 years, 209/317 (66%) paroxysmal AF) a total of 1256 pulmonary veins (PV) were identified and 1252 (99,7%) PVs were successfully isolated utilizing the mainly the short tip POLARx CB (82%). The mean minimal cryoballoon temperature was -57.9±7 °C. Real-time PVI was visualized in 72% of PVs. The mean procedure time 92±41 minutes with a mean fluoroscopy time of 15±10 minutes. Concerning periprocedural complications 1 (0.3%) cardiac tamponade successfully treated by pericardial puncture and 4 (1.3%) pericardial effusion without any intervention were detected. A total of 13 phrenic nerve injuries (4.1%) occurred during treatment of the right superior PV (9/13) and right inferior PV (4/13). Phrenic nerve injury recovered in 3/13 (23%) patients until discharge. Two minor bleeding of the groin (0.6%), 1 (0.3%) severe bleeding with intervention, 5 transient air embolism (1.6%) and 3 (0.9%) stroke / TIA has been observed. Conclusions In this large multicenter assessment the novel POLARx CB shows a promising efficacy and safety profile. Further studies are necessary to draw final conclusion.

Shortened fluoroscopy duration and reduced use of contrast dye in cryoballoon-based pulmonary vein isolation procedures using KODEX-EPD’s novel occlusion tool

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Study grant by EPD Solutions, Philips, Netherlands Background The occlusion tool was recently introduced for KODEX-EPD which is a novel dielectric high-resolution cardiac imaging system. The occlusion tool provides information about level of pulmonary vein occlusion by the cryoballoon (CB) in CB-based pulmonary vein isolation (PVI) ablation procedures for atrial fibrillation (AF). Purpose Assess effects of the introduction of the occlusion tool on procedural parameters during CB-PVI such as feasibility, acute efficacy and periprocedural safety of KODEX-EPD in different software versions. Methods and Results 173 consecutive patients (60/173 (35%) paroxysmal AF, 64±12 years, 66/173 (38%) female) underwent CB-PVI with EPD imaging between 08/2019 and 10/2021. 38/173 (22%) of all patients were treated using software version 1.4.6, 33/173 (19%) patients with version 1.4.6a, 41/173 (24%) patients with version 1.4.7 and 61/173 (35%) patients with the latest version 1.4.8. Acute PVI was achieved in all patients. No major periprocedural complications were documented. Software version showed significant effects on procedure duration, fluoroscopy duration and dose area product in ANOVA testing (Figure 1A-C). The largest effect in post-hoc testing was observed for fluoroscopy duration (Figure 1B). Tobit regressions were fitted to model effects of software version on the censored variable contrast volume. All software versions predicted used contrast volume (p<0.00748, Figure 1D). Modelling only effects of procedure date on contrast volume was less accurate than for software version (r²=0.057, p for procedure date = 0.0031) and also a Likelihood-Ratio-Test between different regression models underlined significant effects of software version (p<0.0001). Conclusion CB-based PVI in combination with its PV-occlusion tool is feasible and safe. The present data strongly suggests a steady positive development of the novel wide-band dielectric imaging and mapping system towards a fluoroscopy- and dye-reduced CB-based AF-ablation. Software versions were introduced sequentially. Therefore time (procedure date) needs to be considered as the most relevant confounder of the described results (e.g. due to a learning curve using the system). However, differentiated statistical testing could show that the results are mainly explained by software version and only much weaker by procedure date.

PO-638-07 GUIDING CATHETER ABLATION COMBINED WITH LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE BY FLUOROSCOPY WITH OR WITHOUT TRANSESOPHAGEAL ECHOCARDIOGRAPHY ACHIEVED COMPARABLE OUTCOMES

Several studies published the safety and efficacy of performing catheter ablation (CA) combined with left atrial appendage occlusion (LAAC) guided by transesophageal echocardiography (TEE). However, intra-procedural TEE monitoring could be difficult as some patients are intolerant. To compare safety and efficacy of guiding CA combined with LAAO by digital subtraction angiography (DSA) with or without TEE. From February 2019 to December 2020, 138 patients with non-valvular atrial fibrillation (AF) underwent CA combined with LAAO procedure were consecutively included, and two cohorts were built according to intra-procedural guidance (DSA or DSA with TEE). Periprocedural and follow-up outcomes were compared to investigate the feasibility and safety between the two cohorts. 71 patients and 67 patients were included in DSA cohort and TEE cohort respectively. Age and gender were comparable, despite TEE cohort has a higher proportion of persistent AF [37 (55.2%) VS 26 (36.6%)] and hemorrhage history [9 (13.4%) VS 0]. The procedure time of the DSA cohort was significantly reduced (95.7±27.6 min VS 108.9±30.3 min, P=0.018), with a non-significant longer fluoroscopic time (15.2±5.4 min vs 14.4±7.1 min, P=0.074) All combined procedure was performed successfully in both cohorts. And the overall incidence of peri-procedural complications were similar between cohorts. After an average of 24 months of clinical follow-up, only three patients in the TEE cohort had ≤ 3mm residual flow (P=0.232). Kaplan-Meier estimates showed non-significant differences between the cohorts for freedom from atrial arrhythmia (log-rank P value=0.964), major adverse cardiovascular events (log-rank P value=0.502) and other events. Compared with DSA and TEE guidance, DSA-guided combined procedure could shorten procedural time, while achieve similar periprocedural and long-term feasibility and safety.

Abstract TP162: Long-term Experience With Resolute Onyx Balloon Mounted Stent For Medically Refractory Intracranial Atherosclerotic Disease Evaluated By Wingspan Stent System Post Market Surveillance (WEAVE) Methodology

Background and Purpose: Angioplasty and stenting is a therapeutic option for patients with medically refractory intracranial atherosclerotic disease (ICAD). We previously demonstrated the feasibility of using Resolute (R) Onyx Stent, a drug-eluting balloon mounted coronary stent (DES), for ICAD patients. WEAVE (Wingspan Stent System Post Market Surveillance) trial assessed the periprocedural safety of Wingspan Stents in ICAD patients. We present our on-going experience with R-Onyx in ICAD patients integrating WEAVE styled methodology to assess outcomes in our cohort. Methods: A prospectively maintained neuro-endovascular database was queried for intracranial angioplasty and stenting cases from October 2019 to June 2021. Patients with symptomatic ICAD despite maximum medical management with >70% stenosis who were treated with R-Onyx DES were included. Primary outcomes were assessed according to WEAVE trial criteria (ischemic or hemorrhagic stroke or death within 72 h of the procedure). Secondary outcomes were assessed by occurrence of stroke and/or in-stent restenosis evaluated 30 days post-procedure clinically or angiographically. Results: A total of 58 patients were eligible for analysis with a mean age of 63.66 years, and 63.8% (n=37) were males. A total of 42 patients had an indication for treatment consisting of recurrent stroke while 16 had recurrent transient ischemic attacks. A total of 62 R-onyx DES stents were used to treat 58 patients with symptomatic lesions with an average stenosis of 84.7%. All procedures were completed successfully with <30% residual stenosis and 1.7% (n=1) of patients having hemorrhage and death within 72 h. Out of 41 patients who had a long-term follow-up, 0 had a stroke. In terms of 6-month angiographic follow-ups, 1 patient had in-stent restenosis treated via angioplasty. Conclusion: Our study reinforces the feasibility of R-Onyx DES for treatment of ICAD refractory to maximal medical management by reporting low periprocedural complication rates (1.7%) according to WEAVE methodology, which itself had a periprocedural complication rate of 2.6%, and low long-term frequencies of indications such as strokes and restenosis. These findings perhaps warrant randomized comparative studies between the stents.

Contour-Assisted coiling with jailed microcatheter May result in better occlusion (CoCoJaMBO) in wide-necked intracranial aneurysms: Proof of principle and immediate angiographic results.

Wide-necked bifurcation aneurysms, partially thrombosed, and recurrences of large and giant aneurysms are challenging to treat. We report our preliminary experience with a Contour-assisted coiling technique and discuss the periprocedural safety, feasibility, and effectiveness of the approach. We retrospectively reviewed consecutive patients who received endovascular treatment for intracranial aneurysms with an intra-aneurysmal flow disruptor (Contour) at two neurovascular centres between October 2018 and December 2020 and identified patients treated with a combination of Contour and platinum coils. Clinical and procedural data were recorded. For this analysis, 8 patients (5 female) aged 60.1 ± 9.2 years on average were identified. Three of 8 aneurysms were associated with previous acute subarachnoid hemorrhage (SAH). The mean average dome height was 12.8 ± 7.6 mm, mean maximum dome width 10.3 ± 5.4 mm, and neck width 5.5 ± 2.5 mm. The mean dome-to-neck ratio was 1.9 ± 1.0. Immediate complete occlusion of the aneurysm was seen in 5 of 8 cases. In one SAH patient, a parent vessel was temporarily occluded but could be reopened rapidly. One device detached prematurely without any sequelae. No other procedural adverse events were recorded. From this initial experience, Contour with adjunctive coiling is a safe and technically feasible method for endovascular treatment of large, wide-necked, partially thrombosed, recurrent, or ruptured bifurcation aneurysms. Further studies with larger numbers of patients and longer follow-up are needed to confirm our results.

The impact of education as a marker of socio-economic status on survival of patients after transcatheter aortic valve implantation.

IntroductionAn association exists between low socio-economic status (SES) and increased cardiovascular and all-cause mortality worldwide.AimTo evaluate the impact of educational level as a marker of socio-economic status (SES) on the clinical condition of patients before transcatheter aortic valve implantation (TAVI) and survival after TAVI.Material and methodsWe conducted a retrospective observational study involving patients with severe aortic stenosis (AS) who underwent TAVI. We divided patients based on their level of education into lower (LLE) and higher educational level (HLE) groups. We evaluated periprocedural (combined endpoints of device success (DS) and early safety (ES), according to VARC2 criteria) and mid-term outcomes (all-cause and cardiovascular mortality).ResultsOf the 379 study patients, 212 were in the LLE group. The mean follow-up was 2.1 ±1.8 years. Patients with a LLE were younger (77.4 ±7.2 vs. 79.4 ±6.5 years, p = 0.006) and more often female (58% vs. 40%, p < 0.001). They had higher body mass index (29.5 ±5.7 vs. 28.3 ±4.8, p = 0.037), more often type 2 diabetes mellitus (43% vs. 31%, p = 0.013) and moderate or severe aortic regurgitation (8% vs. 2%, p = 0.026), and some patients’ condition required urgent TAVI (5% vs. 0%, p = 0.003). There were no differences in combined procedural endpoints. The all-cause mortality during mid-term follow-up was 25% in the LLE group and 24% in the HLE group (log-rank, p = 0.941). Cardiovascular mortality was 19% in both groups (log-rank, p = 0.925).ConclusionsPatients with an LLE required TAVI at a younger age, had more comorbidities and had a more risky profile. Level of education did not influence periprocedural and mid-term outcomes.

Catheter ablation for atrial fibrillation in elderly patients: Systematic review and a meta-analysis.

Catheter ablation (CA) is established therapy for patients with atrial fibrillation (AF); however, there is a limited understanding of CA in elderly patients. We studied the long-term efficacy and periprocedural safety of radiofrequency and cryoballoon CA for elderly patients with AF. PubMed and Embase were searched through April 2021 to investigate the comparative outcomes between elderly and non-elderly patients who underwent CA for AF. The primary efficacy and safety endpoints were AF recurrence and procedure-related complications, respectively. Subgroup analyses were performed by procedure type of CA. The search identified 20 observational studies with 110,606 patients, including 8009 elderly patients (7.2%). The risk of AF recurrence was not significantly different between elderly and non-elderly patients (hazard ratio, 1.37; 95% confidence interval [CI], 0.94-2.00; p=.10, I2 =70%). However, relative to the non-elderly, elderly patients had significantly higher major complications (risk ratio [RR], 1.32; 95% CI, 1.14-1.54], p<.01, I2 =0%) and overall complications (RR, 1.26; 95% CI, 1.00-1.57; p=.05, I2 =56%) with higher cerebrovascular events (RR, 1.68; 95% CI, 1.25-2.25; p=<.01, I2 =0%). Subgroup analysis with cryoballoon CA showed that procedure-related complications in elderly patients were similar to those in non-elderly patients but not with radiofrequency CA. CA for AF in elderly patients has comparable long-term efficacy compared to that in non-elderly patients; however, the incidence of procedure-related complications were higher in elderly patients. Cryoballoon CA did not confer a higher procedure-related risk in elderly patients.

Long-term mortality in asymptomatic patients with stable ischemic heart disease undergoing percutaneous coronary intervention

Patients with stable ischemic heart disease (SIHD) may present with a variety of symptoms including typical angina, angina equivalents such as dyspnea or no symptoms. We sought to determine whether symptom status affects periprocedural safety and long-term mortality in patients undergoing PCI. Prospectively enrolled consecutive patients undergoing PCI for SIHD at six hospitals in Australia between 2005 to 2018 as part of the Melbourne Interventional Group registry. Symptom status was recorded at the time of PCI and patients undergoing staged PCI were excluded. Overall, 11,730 patients with SIHD were followed up for a median period of 5 years (maximum 14.0 years, interquartile range 2.2-9.0 years) with 1,317 (11.2%) being asymptomatic. Asymptomatic patients were older, and more likely to be male, have triple-vessel disease, with multiple comorbidities including renal failure, diabetes and heart failure (all P < .01). These patients had significantly higher rates of periprocedural complications and major adverse cardiovascular events at 30-days. Long-term mortality was significantly higher in asymptomatic patients (27.2% vs 18.0%, P < .001). On cox regression for long-term mortality, after adjustment for more important clinical variables, asymptomatic status was an independent predictor (Hazard ratio (HR) 1.39 95% CI 1.16-1.66, P < .001). In a real-world cohort of patients undergoing revascularization for SIHD, absence of symptoms was associated with higher rates of periprocedural complications and, after adjustment for more important clinical variables, was an independent predictor of long-term mortality. As the primary goal of revascularization in SIHD remains angina relief, the appropriateness of PCI in the absence of symptoms warrants justification.

Predictors of safety and success in minimally invasive surgery for degenerative mitral disease.

The aim of this study was to identify predictors of periprocedural success and safety in minimally invasive mitral valve surgery and to determine the impact of pathology localization and repair technique on reoperation-free survival. We isolated 686 patients (mean age 60.5, standard deviation 12.3 years, 69.4% male) who underwent surgery for mitral valve prolapse between 2002 and 2020 in a single institution. Patients with concomitant disease, redo or mitral pathology other than degenerative mitral disease were excluded from the analysis. Periprocedural safety was defined as: freedom from perioperative death, myocardial infarction, stroke, use of extracorporeal membrane oxygenation or reoperation for bleeding. Operative success was defined as: successful primary mitral repair without conversion to replacement or to larger thoracic incisions, without residual mitral regurgitation > mild at discharge or reoperation within 30 days. Predictors for perioperative success and safety were identified using univariable and multivariable analyses. The impact of prolapse localization and repair technique on reoperation-free survival was assessed by Cox regression. The mitral repair rate and the need for concomitant tricuspid repair were 94.6% and 16.5%, respectively. Perioperative mortality occurred in 5 patients (0.7%). The criteria for perioperative safety and success were met in 646/686 (94.2%) and 648/686 (94.5%) patients, respectively. The absence of tricuspid disease requiring repair was the only independent predictor of safety in this cohort [hazard ratio (HR) 0.460 (0.225-0.941), P = 0.033]. The only independent predictor of operative success was the use of chordal replacement [0.27 (0.09-0.83), P = 0.022]. Reoperation-free survival was 98.5%, 94.5% and 86.9% at 1, 5 and 10 years, respectively. Posterior leaflet pathology demonstrated a higher reoperation-free survival as compared to other localizations (log-rank P = 0.002). The localization of leaflet pathology but not the repair method was an independent predictor for reoperation-free survival (HR 1.455, 95% confidence interval 1.098-1.930; P = 0.009). In minimally invasive mitral surgery for degenerative disease, chordal replacement yields higher rates of periprocedural success than leaflet resection. Posterior leaflet pathology is an independent predictor of reoperation-free survival.

Abstract 1122‐000113: Periprocedural Safety of Intracranial Aneurysm Embolization with Extra Soft Coils: Interim Analysis of SURF Study

This meeting abstract was removed due to the OA licensing requirements of this journal. The full abstract is listed here : https://www.svin.org/files/SVIN_2021_Abstracts_for_Web.pdf

Intravascular lithotripsy in calcified peripheral lesions: the real-world single-center JEN-experience

Abstract Objective Peripheral vascular disease (PVD) is a major cause of morbidity and mortality with increasing need for interventional therapies. Vascular calcification increases risk of complications and may impair the effect of antiproliferative therapy. Intravascular lithotripsy (IVL) using pulsatile sonic pressure waves to modify intimal and medial calcium is a promising approach for those patients to overcome the drawbacks of vascular calcification. Purpose A single-center, prospective registry of patients undergoing peripheral lithotripsy was established. Periprocedural safety events as well as short and long term follow-up clinical data were evaluated. Methods A prospective review of cases using IVL was performed for the period from December 2018 to January 2021 at our center. Angiographic images were quantified by using the QVA 8.0 module, Medis Suite Version 3.2.60.4 developed by Medis Imaging Systems. Results 61 cases of IVL were performed in 51 patients with Rutherford class 3. Mean age was 71 years with 78% (28) of the patients being men. Diabetes was present in 80% and renal insufficiency in 47% of the cases. The median calcified lesion length treated was 82 mm (10; 390 mm) with a PACCS sore of 3 (1; 3), indicating a highly calcified status. In 41% (n=25), predilation was necessary. We treated 8 iliac-, 19 common femoral-, 52 superficial femoral-, 5 deep femoral-, 29 popliteal- and 2 crural- lesions with balloon sizes ranging from 4.0 to 7.0 mm. In 35 (57%) cases IVL was used as a stand-alone therapy, in the remaining 26 an adjunctive therapy (DCB and/or stent) was used. We were able to reach an acute luminal gain of 2.5 mm. A ballon rupture occurred in 6 (10%) cases. There were no other complications. Mean ABI improved from 0.6 to 0.8 (p&amp;lt;0.0001) immediate after the intervention. Follow-up after 6 months again demonstrated an improved ABI of 0.8 (p&amp;lt;0.0001 vs. baseline). Conclusion This first real-world data of IVL reports compelling safety of IVL in a complex, difficult-to-treat patient cohort. For the first time, clinical follow-up data were presented and demonstrated a sustained improved ABI after 6 months. This innovative approach will gain more interest in the future, especially since long term effects of paclitaxel eluting devices are controversially discussed. Funding Acknowledgement Type of funding sources: None. ABI initial follow-up

A first dedicated heart valve unit: safe and streamlined patient care for the rapidly growing field of transcatheter heart valve interventions

Abstract Background A dedicated Heart Valve Unit was launched in 2018 to meet the demands of the growing transcatheter heart valve program by optimizing patient care in a single dedicated unit. Purpose To assess the performance of the heart valve unit (all steps of patient care in a single unit with intermediate care facilities) over a conventional approach (preparation on a normal ward, postprocedural intensive care unit (ICU) monitoring and transfer to an additional monitoring ward before discharge) in a high volume center. Methods Retrospective analysis including patients undergoing transcatheter mitral or tricuspid valve repair who were admitted to the Heart Valve Unit (02/2018–01/2020) compared to a conventional patient care approach (02/2016–01/2018). Patients who were already preprocedurally admitted to the ICU or in whom ICU monitoring postprocedurally was mandatory (direct annuloplasty, valve replacement) were excluded. The Heart Valve Unit patient care algorithm is presented in figure 1. We assessed procedural numbers, length of hospital stay, length and need for ICU monitoring, patient transfers between wards and periprocedural safety including in-hospital mortality. Results We observed a 164% increase in procedures (521 vs. 316 in total, 369 vs 282 with mitral valve procedures and 152 vs 34 tricuspid valve procedures) with the launch of the Heart Valve Unit over the 2-year-interval compared to the earlier time period. Length of in-hospital stay was significantly decreased compared to a conventional approach (9±7 vs. 12±11 days, p&amp;lt;0.001). In particular, postprocedural stay could be shortened from 7±7 to 5±6 days (p&amp;lt;0.001). Patients were less transferred between different wards in the Heart Valve Unit setting (p&amp;lt;0.001). Whereas all patients were postprocedurally transferred to the ICU in the conventional setting, only 16% of patients required an ICU bed immediately after the procedure due to complex interventions, intraprocedural events or high-risk comorbidities. The length of stay on ICU declined from 1.4±1.4 to 0.5±2.2 days. Among the patients re-transferred to the Heart Valve Unit directly after the procedure, 2% (10 patients) required an ICU bed in the further course due to hemodynamic instability (2), severe bleeding (4), seizures (1), ventricular fibrillation (1), anaesthetic overhang (1) or after urgent surgery due to a atrioventricular fistula (1). After stabilization, all patients were re-transferred to the Heart Valve Unit and discharged hereinafter. There was no intra-hospital death among these patients. Conclusions A dedicated Heart Valve Unit allows a safe and optimized patient care structure for transcatheter valvular interventions by combining all pre- and postprocedural steps in a single unit, thereby decreasing length of in-hospital stay to meet increasing economic demands. ICU capacity can be specifically used for complex procedures aftercare and complication monitoring. Funding Acknowledgement Type of funding sources: None.

Long-term outcomes and periprocedural safety and efficacy of percutaneous left atrial appendage closure in a United Kingdom tertiary center: An 11-year experience.

Left atrial appendage occlusion (LAAO) has been widely adopted as a strategy for stroke prevention in patients with atrial fibrillation ineligible for oral anticoagulation. The purpose of this study was to explore longer-term "real-world" safety and efficacy outcomes in patients undergoing LAAO given varied practices in antithrombotic regimens and adoption of same-day discharge. Analysis of acute procedural and long-term outcome data was performed for all patients undergoing LAAO implant in a United Kingdom tertiary center over an 11-year period. Rates of adverse events were calculated and compared to predicted rates in historical cohorts according to CHA2DS2-VASc and HAS-BLED scores. Device implantation was attempted in 229 patients, with an acute procedural success rate of 98.2% and low rate of major procedural complications of 2.6% at 30 days, including 1.3% procedure-related mortality. In the last year of enrollment, 75% of patients were discharged on the same day of the procedure. A strategy of early cessation of antithrombotic therapy was adopted, with a low rate of device-related thrombus. Over total follow-up of 889 patient-years, there were low rates of thromboembolic events (2.2/100 patient-years) and of significant bleeding events (intracranial bleed 0.6/100 patient-years; nonprocedural major bleeding 2.3/100 patient-years). LAAO with a same-day discharge strategy and early cessation of antiplatelet therapy seems to be safe and effective in reducing the risk of stroke and major bleeding over mean follow-up approaching 4 years. Although these data are reassuring, results from randomized trials with strict shorter periods of postprocedural antithrombotic therapy are eagerly awaited.

REtrospective Multicenter INdian Study of Derivo Embolization Device (REMIND): Periprocedural Safety.

PurposeThe treatment of aneurysms with characteristics such as complex morphology, fusiform, blister-like, wide neck, or large size has been revolutionized with the introduction of flow diverters. Though flow diverters have several advantages over coiling, they also have certain important disadvantages such as the lack of immediate protection against rupture, the risk of ischemic stroke, the need for antiplatelet therapy, and long latency for complete effect. The Derivo Embolization Device (DED) is a second-generation self-expanding device that is claimed to be less thrombogenic than conventional devices. We retrospectively evaluated the periprocedural safety and risks associated with the DED across 5 centers in India.Materials and MethodsThis is a multicentric, retrospective, observational study of DED, conducted at 5 high volume endovascular therapy centers in India from May 2018 to June 2020. Periprocedural demographic, clinical, and angiographic data were collected from a retrospective review of patient charts.ResultsA total of 96 patients, including 56 (58.3%) females, aged between 16–80 years (60±12.7 years) harboring 106 aneurysms were studied. Seven (7.3%) were noted to harbor multiple aneurysms: 6 had 3 aneurysms each, while 1 patient had 5 aneurysms. The following aneurysm characteristics were noted: average size, 9.8±8.2 mm; average neck size, 6.9±8.5 mm; wide-necked (>4 mm), 63 (59.4%); giant (>25 mm), 8 (7.5%); and anterior circulation location, 98 (92.5%). Eighteen (17%) of these were ruptured. Additional balloon angioplasty was performed in 5 (5.2%) patients. Intraprocedural problems were encountered in 3 (3.1%), of which only 1 had clinical implications, the device fish-mouthing with stent thrombosis resulting in a malignant middle cerebral artery territory infarction. The modified Rankin scale at 3 months was worse in 1 patient.ConclusionDED is a newer generation flow diverter stent with a low periprocedural complication rate.

Safety of the transradial approach to carotid stenting.

The multicenter prospective CREST-2 Registry (C2R) provides recent experience in performing carotid artery stenting (CAS) for interventionists to ensure safe performance of CAS. To determine the periprocedural safety of CAS performed using a transradial approach relative to CAS performed using a transfemoral approach. Patients with ≥70% asymptomatic and ≥50% symptomatic carotid stenosis, ≤80 years of age and at standard or high risk for carotid endarterectomy (CEA) are eligible for the C2R. The primary endpoint was a composite of severe access-related complications. Comparisons were made using propensity-score matched logistic regression. The mean age of the cohort was 67.6 ± 8.2 years and 1906 (35.1%) were female. Indications for CAS included 4063 (74.9%) for primary atherosclerosis. A total of 2868 (52.8%) cases underwent CAS for asymptomatic disease. Transradial access was used in 213 (3.9%) patients. The transradial cohort had lower use of general anesthesia (1.5% vs. 6.3%, p=0.007) and higher use of distal embolic protection (96.7% vs. 89.4%, p=0.0004). There were no significant differences between radial and femoral access groups in terms of a composite of major access-related complications (0% vs. 1.1%) or a composite of periprocedural stroke or death (3.3% vs. 2.4%; OR=1.4 [confidence intervals 0.6, 3.1]; p=0.42). We found no significant differences in rates of major access-related complications or periprocedural stroke or death with CAS performed using transradial compared to transfemoral access. Our results support incorporation of the transradial approach to clinical trials comparing CAS to other revascularization techniques.

European Society of Hypertension position paper on renal denervation 2021.

This ESH Position Paper 2021 with updated proposed recommendations was deemed necessary after the publication of a set of new pivotal sham-controlled randomized clinical trials (RCTs), which provided important information about the efficacy and safety of endovascular device-based renal denervation (RDN) for hypertension treatment. RDN is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity. Five independent, fully completed, sham-controlled RCTs provide conclusive evidence that RDN lowers ambulatory and office blood pressure (BP) to a significantly greater extent than sham treatment. BP-lowering efficacy is evident both in patients with and without concomitant antihypertensive medication. The average decrease of 10 mmHg in office BP is estimated to lower the incidence of cardiovascular events by 25-30%, based on meta-analyses of RCTs using pharmacological treatment. Neither peri-procedural, nor short-term or long-term adverse events or safety signals (available up to 3 years) have been observed. Implementing RDN as an innovative third option in the armamentarium of antihypertensive treatment requires a structured process that ensures the appropriate performance of the endovascular RDN procedure and adequate selection of hypertensive patients. The latter should also incorporate patients' perspective and preference that needs to be respected in a shared decision-making process.

Impact of atrial fibrillation pattern on outcomes after left atrial appendage closure: lessons from the prospective LAARGE registry

BackgroundNon-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death.MethodsComparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE).ResultsA total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02–2.72, p = 0.041).ConclusionAtrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality.Graphic abstract

Periprocedural safety and efficacy after left atrial appendage closure in a large UK tertiary centre: 10-year experience

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage (LAA) thrombus is responsible for up 90% of atrial fibrillation (AF) related ischaemic strokes. Mechanical closure of the LAA is an alternative stroke prevention strategy in patients with non-valvular AF who are at a high risk of bleeding. LAA morphology is highly variable which may affect acute procedural success rates. Purpose This study sought to examine the periprocedural safety and efficacy, and short-term outcomes in patients undergoing left atrial appendage occlusion (LAAO) device implantation in a large UK tertiary centre. Methods This retrospective study included all patients listed for a LAAO device in our institution from January 2010 to December 2020. Medical notes, procedural and imaging reports were reviewed and adverse event rates were calculated at discharge, 30 and 90 days. A Cox regression model was used for multivariable analysis with pre-specified covariates to assess outcomes at 90 days. Results Of 237 patients listed for a LAAO device, 8 (3.4%) had a LAA thrombus and the procedure was abandoned (4 had a successful implant at a later date). In 225 (94.9%) patients a LAAO device was implanted and 4 (1.7%) had unsuitable anatomy precluding device deployment. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 major or life-threatening bleeding episodes). The mean procedural and fluoroscopy time were 52.5 ± 30.5 and 8.0 ± 5.9 minutes, respectively. Three different LAAO devices were used (136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac Plug) with no significant difference in acute procedural success (97.8%, 98.2% and 94.4%, p = 0.41, respectively). Complete seal was achieved in 202 (92%) patients with only 1 (0.4%) moderate leak. Procedure-related mortality was 1.3% and non-fatal serious adverse events occurred in 5 (2.1%) patients. At 90 days, 28 patients experienced an adverse event (KM 12.5%; 95% CI, 8%-16.1%) and 16 patients suffered a serious adverse event (KM 7.1%; 95% CI, 3.7%-10.4%). In a covariate-adjusted Cox model, CHA2DS2-VASc score less than 4 had hazard ratio of 0.21 (95% CI, 0.06 -0.71, p = 0.01) for serious events at 90 days. Conclusion The acute procedural success rate was high (97%) with a low number of periprocedural complications. Serious adverse events at both 30 and 90-days were low in keeping with other published registries. Abstract Figure.