Periprocedural Events Research Articles

Real-world safety and efficacy of WATCHMAN LAA closure at one year in patients on dual antiplatelet therapy: results of the DAPT subgroup from the EWOLUTION all-comers study.

The study aimed to confirm the efficacy and safety of WATCHMAN LAA closure in atrial fibrillation patients unsuitable for oral anticoagulation. The EWOLUTION registry prospectively collects all clinical data on 1,005 European patients implanted with a WATCHMAN device. Following the procedure, 605 patients (60.2%) received dual antiplatelet therapy according to the local standard; DAPT was discontinued in 85% of patients within one year. CHA2DS2-VASc and HAS-BLED scores were 4.61.6 and 2.41.2, respectively. The periprocedural SAE rate was 3.3% (2.0% major adverse cardiac events), mostly resolving without sequelae. Device embolisation or pericardial effusion occurred in one (0.2%) and two (0.3%) patients, respectively. TEE (median 62 days post implant, IQR: 47-97) confirmed effective sealing (no leak >5 mm) in 99.2% of patients. Device thrombus was present in 22 patients (4.0%), one patient developed a stroke. One-year mortality in the DAPT group was 9.6% (N=58) reflecting the advanced age and comorbidities in this population. The ischaemic stroke rate at one year was 1.4% (expected based on CHA2DS2-VASc: 7.5%), none fatal. The major bleeding rate was 2.5%, or 2.1% excluding periprocedural events (expected rate on VKA based on HAS-BLED: 5.1%). LAA closure with the WATCHMAN device followed by DAPT therapy in a high-risk patient population is safe. At one year, the intervention is associated with a substantial risk reduction regarding ischaemic stroke and major bleeding compared to the expected rate based on CHA2DS2-VASc and HAS-BLED scores.

Impella support following emergency percutaneous balloon aortic valvuloplasty in patients with severe aortic valve stenosis and cardiogenic shock

BackgroundTo investigate the feasibility and outcomes of Impella 2.5 support in patients with severe aortic valve stenosis (AS) and cardiogenic shock (CS), who underwent emergency percutaneous balloon aortic valvuloplasty (BAV) with or without percutaneous coronary intervention (PCI). Methods and resultsWe retrospectively analyzed a consecutive series of patients with severe AS and CS who underwent Impella 2.5 support following emergency BAV with or without subsequent PCI. Outcome data included 30-day outcomes, periprocedural as well as throughout the circulatory support period complications. Eight patients with severe AS and CS were identified. Impella 2.5 implantation was successful following emergency BAV in all patients attempted. Additional PCI was performed in four patients. No periprocedural deaths or periprocedural neurologic events occurred. Mean procedure time was 125.9 min (range 64–210 min). Mortality at 30 days was 50%. ConclusionsImpella 2.5 can be used as hemodynamic support in patients with severe AS and CS following emergency percutaneous BAV and may help to improve tolerability of PCI in these high-risk patients.

Comparison between activated clotting time and anti-activated factor X activity for the monitoring of unfractionated heparin therapy in patients with aortic aneurysm undergoing an endovascular procedure

ObjectiveCurrent guidelines recommend administration of unfractionated heparin (UFH) and measurement of activated clotting time (ACT) during endovascular procedures. The aim of this study was to compare ACT and anti-activated factor X (anti-Xa) measurements for monitoring of UFH therapy during an aortic endograft procedure and to assess the association of peak ACT and peak anti-Xa activity with periprocedural bleeding. MethodsWe retrospectively studied 104 patients with aortic aneurysm undergoing endovascular procedures with repeated coagulation measurements. After a UFH bolus, further UFH doses were given according to ACT (target range, ≥250 seconds) in clinical routine, and in parallel to each ACT (Hemochron; Accriva Diagnostics, Newport Beach, Calif) measurement, we determined anti-Xa activity (HemosIL Liquid anti-Xa; Instrumentation Laboratory, Bedford, Mass). UFH redosing was solely based on the ACT measurements. We defined periprocedural bleeding as a drop in hemoglobin level ≥3 g/dL or red blood cell transfusion within 24 hours. ResultsAfter the initial UFH bolus (median, 67 IU/kg body weight), ACT and anti-Xa measurements showed a weak correlation (rs, 0.46; P < .001). Median ACT was 233 seconds (range, 127-374 seconds; interquartile range [IQR], 204-257 seconds); median anti-Xa activity was 1.0 IU/mL (range, 0.5-2.0 IU/mL; IQR, 0.9-1.2 IU/mL). Only 31% of the patients had an ACT value ≥250 seconds, whereas all patients had an anti-Xa activity ≥0.5 IU/mL. Accordingly, ACT triggered redosing of UFH frequently. Consequently, we saw a median total UFH use of 90 IU/kg during the procedure, a median peak ACT of 255 seconds (IQR, 234-273 seconds), and a median peak anti-Xa activity of 1.2 IU/mL (IQR, 1.0-1.4 IU/mL). Periprocedural bleeding occurred in 40 (38%) patients. Peak ACT ≥250 seconds was not associated with bleeding (odds ratio, 1.05; 95% confidence interval, 0.41-2.70; P = .952), whereas peak anti-Xa activity ≥1.2 IU/mL was independently associated with bleeding (odds ratio, 4.95; 95% confidence interval, 1.82-13.48; P = .002). Moreover, no periprocedural thromboembolic event occurred. ConclusionsIn this retrospective study of patients with aortic aneurysm undergoing an endovascular procedure, ACT and anti-Xa measurements showed poor correlation; only increased peak anti-Xa activity was independently associated with periprocedural bleeding, not increased ACT. Our findings also suggest that monitoring of UFH therapy with anti-Xa during aortic endograft procedures may reduce total UFH use. We further speculate that this approach could reduce periprocedural bleeding.

Duration of hospital admission, need of on-demand analgesia and other peri-procedural and short-term outcomes in sub-cutaneous vs. transvenous implantable cardioverter–defibrillators

BackgroundPost-procedural recovery following sub-cutaneous ICD (S-ICD) implantation is feared to be more painful and to require more prolonged hospital admission. The purpose of this study was to compare peri-procedural and short clinical outcomes of the S-ICD vs. the Transvenous ICD (TV-ICD). MethodsWe conducted a single-center cross-sectional study including all consecutive patients who underwent S-ICD implantation by the same operator since January 2016 and a gender and age-matched control group with all single chamber TV-ICD implanted patients over a contemporary time period. ResultsThirty-one patients (sex ratio 1/5; mean age 58.7±13.2years) with S-ICD were compared to 31 matched TV-ICD patients. Duration of the implant procedure was significantly longer for the S-ICD (58.0±24.4min vs 41.7±20.8min TV-ICD, p<0.01). Mean fluoroscopy time for the TV-ICD was 3.5±3.6min vs 0.1±0.01min for all S-ICD patients (p<0.01). Requirement of on-demand analgesia administration, and duration of hospitalization (1.5days for both groups; p=NS) were similar in the two groups. No peri-procedural events were reported, and after a mean follow-up of 6months, the only complication was a pocket infection requiring reintervention in the TV-ICD group. ConclusionsThe S-ICD appears to be as effective and safe as the conventional single chamber TV-ICD. Duration of hospital admission and need of on-demand analgesia are also comparable for S-ICD patients.

Comparison of the Efficacy and Safety of Orbital and Rotational Atherectomy in Calcified Narrowings in Patients Who Underwent Percutaneous Coronary Intervention

We aimed to compare the safety and efficacy of rotational atherectomy (RA) and orbital atherectomy (OA) during percutaneous coronary intervention in an all-comer population with severely calcified lesions. We included all patients who underwent percutaneous coronary intervention with OA or RA in our institution from October 2013 until October 2016. Comparison of baseline and procedural characteristics, along with acute complication rates and postprocedural cardiac enzyme elevation, was performed. There were 191 RA and 57 OA patients. Other than creatinine clearance, which was lower in patients with OA (p = 0.01), there were no differences in baseline characteristics. OA was more frequent in left anterior descending artery lesions (p = 0.02), whereas RA was more common in right coronary artery lesions (p = 0.01). Intracoronary imaging rates were above 60% in both groups. There was a higher rate of coronary dissections with OA compared with RA (p = 0.003), but there was no difference in periprocedural events. Maximal troponin levels were similar in both groups. Residual stenosis measured by intravascular ultrasound in 29 patients revealed no significant differences between OA and RA (p = 0.58). In conclusion, RA and OA have similar safety and efficacy profiles in treating patients with calcified coronary lesions, and intracoronary imaging is highly beneficial in identifying coronary injury after atherectomy procedures.

Abstract TP128: Multicenter Experience With Stenting for Carotid Webs

Background: Carotid web is a shelf-like lesion in the posterior aspect of the internal carotid bulb and represents an intimal variant of fibromuscular dysplasia. Carotid webs have been associated with recurrent strokes and traditionally treated with surgical excision. We report a multicenter experience of stenting in patients with symptomatic carotid webs. Methods: Retrospective review of patients admitted to three comprehensive stroke centers identified to have a carotid web with otherwise negative stroke workup that underwent stenting. A carotid web was defined by the presence of a shelf-like/linear, smooth filling defect in the posterior aspect of the carotid bulb diagnosed by neck CT/MR angiography and confirmed with conventional angiography. Results: Twenty patients with symptomatic (80% Stroke/20% TIA) carotid webs were stented. Median age was 48[41-61] years, 7(35%) were male, and 15(75%) Black. Median NIHSS was 11[2-16] while ASPECTS 8[7-8]. Eight (40%) received intravenous thrombolysis and 10 (50%) thrombectomy. All patients were stented on dual antiplatelets (aspirin and clopidogrel[17] or ticagrelor[3]) at a median 9[4-30]days after the last vascular event. Closed-cell stents were used in 75% of cases (XACT [14] and Wallstent [1]) while open-cell stents in 25% (Acculink[5]). No cases required angioplasty for residual stenosis had to be performed. DIstal embolic protection was used in 19 cases (SpiderFX[18] and Emboshield_NAV6[1]) while proximal protection in 1 (MoMa). No periprocedural events occurred with the exception of two cases of hypotension/bradycardia (one requiring 24-hour vasopressors). No parenchymal hematomas were observed but one patient developed vaginal hemorrhage requiring discontinuation of one antiplatelet at 2 months. Modified Rankin Scale 0-2 (independence) at 90 days was recorded in 95% of patients. Clinical follow-up post stent occurred for a median of 4 [2-12] months and no follow-up cerebrovascular events were noted. Follow-up vascular imaging was performed in 95% patients at a median of 3[2-12]months and were all unremarkable. Conclusions: Stenting for symptomatic carotid web appears to be a valid, safe, and effective alternative to surgical piecemeal resection. Further studies are warranted.

Incidence and prognostic factors related to major adverse cerebrovascular events in patients with complex aortic diseases treated by the chimney technique

ObjectiveEndovascular aneurysm repair (EVAR) with the chimney technique (ch-EVAR) has been used for the treatment of aortic aneurysms as an alternative approach to fenestrated endografting or open repair. Nonetheless, the need for an upper extremity arterial access may contribute to a higher risk for periprocedural cerebrovascular events. This study reports on the perioperative cerebral and major adverse cardiac and cerebrovascular events (MACCE) after ch-EVAR. MethodsThe PERICLES registry (PERformance of the chImney technique for the treatment of Complex aortic pathoLogiES) is an international, retrospective multicenter study evaluating the performance of ch-EVAR for the treatment of complex aortic pathologies. For the purpose of the current analysis, 425 patients treated by ch-EVAR between 2008 and 2014 were included. The primary outcome of this analysis was the incidence of procedure related cerebrovascular events defined as transient ischemic attack or stroke. The secondary end point was in-hospital MACCE, including acute coronary syndrome, stroke, and death of any cause. ResultsThe incidence of clinical relevant cerebrovascular events was 1.9% (8/425). A postoperative transient ischemic attack was observed in four patients (0.95%) and a stroke in additional four (0.95%). Three patients died during the hospital stay secondary to sequelae from postoperative stroke. A prior history of stroke/transient ischemic attack, atrial fibrillation, previous carotid revascularization, or known carotid artery disease did not significantly increase the risk for adverse neurologic events. The overall MACCE rate amounted to 8.5% (36/425). Logistic regression analysis revealed that the use of bilateral upper extremity access (odds ratio [OR], 2.79; 95% confidence interval [CI], 1.04-7.45]), aneurysm rupture (OR, 5.33; 95% CI, 1.74-16.33), and a prolonged operation time (>290 minutes; OR, 1.005; 95% CI, 1.001-1.008) were associated with a significantly increased risk for MACCE. ConclusionsThis analysis demonstrates that ch-EVAR is associated with a relatively low rate of cerebrovascular events. However, a postoperative stroke is associated with increased mortality. Ruptured aneurysms, bilateral upper extremity access as in case of multiple chimney graft placement, and longer operative times were identified as independent risk factors for MACCE.

Coronary dominance and predictors of adverse events during coronary interventional procedures: an observational study

Background: Coronary dominance is associated with adverse peri-procedural events during coronary interventions. There are limited data regarding events during coronary angiography in Nepal.Aims and methods: The aim of this article is to get information regarding events during invasive procedures of this region which has a large feeder population. All the cases undergone cardiac interventional procedures were included and analyzed.Results: Out of 200 cardiac interventional procedures, 160 cases underwent coronary angiography (CAG) and 20 percutaneous coronary intervention (PCI). 54% of the study populations were male. The mean age of study population was 61.2 years (range: 29-85 years). Most common indication for performing CAG was for post ACS (69%) followed by chronic stable angina (CSA) (16%). Most common finding in CAG was SVD (35%) LAD was the commonest (55% of SVD), DVD (19%), non-critical CAD (13%), TVD (14%) and left main (2%). Myocardial bridging was seen in 2% and 15% had normal coronaries. Commonest risk factor for CAD was Hypertension (45%) followed by smoking (35%) and diabetes (16%). CAG was most commonly performed from right radial (70%) followed by right femoral (24%), left radial (5%) and left femoral (1%). 78% of patients had right dominance, 16% had left dominance while 6% had co-dominance. Out of 40 non-right dominant (left or co-dominant) patient twenty three (57.5%) were female. There was no significant association of left dominance with the gender although the odds ratio was high (1.8) in female gender (P=0.12). Considering Left dominant patients only, the odds ratio of Tiger catheter versus Judkins Right (JR) is 8.33 but not statistically significant (P=0.17). Major complications encountered were ventricular tachycardia (VT) in 4 cases. The odds for VT with left dominance and right dominance was high with statistical significance [OR: 53.48, C.I :( 2.79-1023.4); P=0.002].Conclusion: Ventricular tachycardia which is among the major complication is found to be significantly associated with left dominance. Further studies are necessary to evaluate the evidence provided by this study.

Complete filter-based cerebral embolic protection with transcatheter aortic valve replacement.

To evaluate the value of left vertebral artery filter protection in addition to the current filter-based embolic protection technology to achieve complete cerebral protection during TAVR. The occurrence of cerebrovascular events after transcatheter aortic valve replacement (TAVR) has fueled concern for its potential application in younger patients with longer life expectancy. Transcatheter cerebral embolic protection (TCEP) devices may limit periprocedural cerebrovascular events by preventing macro and micro-embolization to the brain. Conventional filter-based TCEP devices cover three extracranial contributories to the brain, yet leave the left vertebral artery unprotected. Patients underwent TAVR with complete TCEP. A dual-filter system was deployed in the brachiocephalic trunk and left common carotid artery with an additional single filter in the left vertebral artery. After TAVR all filters were retrieved and sent for histopathological evaluation by an experienced pathologist. Eleven patients received a dual-filter system and nine of them received an additional left vertebral filter. In the remaining two patients, the left vertebral filter could not be deployed. No periprocedural strokes occurred. We found debris in all filters, consisting of thrombus, tissue derived debris, and foreign body material. The left vertebral filter contained debris in an equal amount of patients as the Sentinel filters. The size of the captured particles was similar between all filters. The left vertebral artery is an important entry route for embolic material to the brain during TAVR. Selective filter protection of the left vertebral artery revealed embolic debris in all patients. The clinical value of complete filter-based TCEP during TAVR warrants further research.

323 Comparison Between Balloon-Assisted and Stent-Assisted Technique for Treatment of Unruptured Internal Carotid Artery Aneurysms

Abstract INTRODUCTION Balloon and stent are representative of assistant devices for wide-neck aneurysm coiling. To date, there were no studies comparing balloon-assisted (BAC) and stent-assisted coiling (SAC) for the treatment of internal carotid artery unruptured aneurysms (ICA-UA). METHODS We sought to characteristics of patients and aneurysms, and clinical and angiographic prognosis between groups. Total number of ICA-UA was 227 in 190 patients. Two groups were separted into BAC group (141 ICA-UA in 120 patients) and SAC group (86 ICA-UA in 70 patients). RESULTS &gt;In SAC, aneurysm size and neck diameter tended to be larger than in BAC, but aneurysm volume and packed density of coil were not different between groups. Immediate angiographic occlusion grade was better for BAC than for SAC. Periprocedural thromboembolic events were more frequent during SAC (11.6%) than BAC (2.4%) per aneurysm, but hemorrhagic events were the opposite (2.4% for BAC and none for SAC per aneurysm) (P &lt; 0.05). At discharge, treatment-related morbi-mortality rates were 1.6% for BAC and 1.4% per patient for SAC. At clinical follow-up (BAC, 118 patients [98.3%] for a mean of 48.4 months; SAC, 69 patients [98.6%], for a mean of 37.4 months), 1 additional treatment-related infarction occurred during SAC, resulting in a modified Rankin scale score of 4. Thus, overall treatment-related morbidity-mortality rates were 1.7% in BAC and 2.9% in SAC. At imaging follow-up (BAC, 135 aneurysms [95.7%] for 28.3 months; SAC, 81 aneurysms [94.1%] for 23.9 months), BAC and SAC showed stable or improved occlusion in 94.1% and 95.0%, minor recurrence in 4.4% and 2.5%, and major recurrence in 1.5% and 2.5%, respectively. CONCLUSION Both BAC and SAC were safe and effective techniques for ICA-UA. There were no differences in morbidity, mortality and recurrence rates between groups, despite their opposite trends.

Thrombo-embolic prevention after transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has emerged as a valuable treatment alternative to surgical aortic valve replacement among patients with symptomatic aortic stenosis at increased surgical risk. The rapid technological evolution from early to current-generation TAVI systems with low-profile delivery catheters, bioprosthetic valves with proven midterm durability, and improved positioning and retrieval features have made important contributions to the widespread clinical use of this minimal invasive therapy. Although peri-procedural and long-term thrombotic and bleeding events after TAVI remain a relevant concern, the optimal antithrombotic strategy and duration to mitigate these risks remain unclear. This review provides an overview of recent insights in this field, and highlights current and future antithrombotic trials focusing on optimizing outcomes in patients undergoing TAVI.

Predictors of pre-procedural concentrations of direct oral anticoagulants: a prospective multicentre study.

Patients receiving direct oral anticoagulants (DOACs) frequently undergo elective invasive procedures. Their management is challenging. We aimed to determine the optimal duration of DOAC discontinuation that ensures a minimal anticoagulant effect during the procedure. This prospective multicentre study included 422 DOAC-treated patients requiring an invasive procedure. Pre-procedural DOAC concentration ([DOAC]) and routine haemostasis assays were performed to determine i/the proportion of patients who achieved a minimal pre-procedural [DOAC] (≤30 ng/mL) according to the duration of DOAC discontinuation, ii/the predictors of minimal [DOAC] and, iii/the ability of routine assays to predict minimal [DOAC]. Lastly, we assessed the predictors of peri-procedural bleeding events. The duration of DOAC discontinuation ranged from 1 to 218 h and pre-procedural [DOAC] from ≤30 to 527 ng/mL. After a 49-72-h discontinuation, 95% of the [DOAC] were ≤30 ng/mL. A 72-h discontinuation predicted concentrations ≤30 ng/mL with 91% specificity. In multivariable analysis, duration of DOAC discontinuation, creatinine clearance <50 mL/min and antiarrhythmics were independent predictors of minimal pre-procedural [DOAC] (concordance statistic 0.869; 95% confidence interval: 0.829-0.912). Conversely, routine haemostasis assays were poor predictors. Last, creatinine clearance <50 mL/min, antiplatelets and high-bleeding risk procedures were predictors of bleeding events. A last DOAC intake 3 days before a procedure resulted in minimal pre-procedural anticoagulant effect for almost all patients. Moderate renal impairment, especially in dabigatran-treated patients, and antiarrhythmics in anti-Xa-treated patients should result in a longer DOAC interruption. In situations requiring testing, routine assays should not replace DOAC concentration measurement.

Outcomes after catheter ablation and cardioversion in patients with non-valvular atrial fibrillation: results from the prospective, observational XANTUS study.

In patients with atrial fibrillation, catheter ablation and cardioversion carry a risk of peri-procedural thromboembolic events; current guidelines recommend anticoagulation in these settings. This study aimed to report the baseline demographics and clinical characteristics of patients enrolled in the prospective, observational XANTUS study who underwent catheter ablation or cardioversion, and adverse outcomes with each of these procedures in patients treated with rivaroxaban. Data collected included information on catheter ablation and cardioversion, and adverse outcomes occurring within 30 days of these procedures: incidence of treatment-emergent adjudicated symptomatic thromboembolic events and major bleeding; and cardiovascular and all-cause death. Incidence of these adverse outcomes at 42 days after cardioversion was also analysed. Patients undergoing either procedure had significantly lower mean CHA2DS2-VASc and HAS-BLED scores than those who did not, and were more frequently hospitalized at study baseline. Within a period of 30 days after intervention, symptomatic thromboembolic events were reported in 1.2% and 0.6% of patients undergoing ablation or cardioversion, respectively; major bleeding events were reported in 2.9% and 0.4% of patients undergoing ablation or cardioversion, respectively. No patients died within 30 days of intervention. Incidence of symptomatic thromboembolic and major bleeding events remained low at 42 days after cardioversion. Similar to the results of prospective and non-interventional studies, the low rates of symptomatic thromboembolic events and major bleeding in patients with atrial fibrillation undergoing ablation or cardioversion and treated with rivaroxaban in XANTUS suggest that its use is associated with an acceptable benefit-risk profile in this setting. Clinicaltrials.gov: NCT01606995.

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves.

Transcatheter mitral valve replacement (TMVR) is a novel approach for treatment of severe mitral regurgitation. A number of TMVR devices are currently undergoing feasibility trials using both transseptal and transapical routes for device delivery. Overall experience worldwide is limited to fewer than 200 cases. At present, the 30-day mortality exceeds 30% and is attributable to both patient- and device-related factors. TMVR has been successfully used to treat patients with degenerative mitral stenosis (DMS) as well as failed mitral bioprosthesis and mitral repair using transcatheter mitral valve-in-valve (TMViV)/valve-in-ring (ViR) repair. These patients are currently treated with devices designed for transcatheter aortic valve replacement. Multicenter registries have been initiated to collect outcomes data on patients currently undergoing TMViV/ViR and TMVR for DMS and have confirmed the feasibility of TMVR in these patients. However, the high periprocedural and 30-day event rates underscore the need for further improvements in device design and multicenter randomized studies to delineate the role of these technologies in patients with mitral valve disease.

Cerebral white matter lesion burden is associated with the degree of aortic valve calcification and predicts peri-procedural cerebrovascular events in patients undergoing transcatheter aortic valve implantation (TAVI).

To investigate the impact of aortic valve calcification and brain morphology on acute peri-procedural cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve implantation (TAVI). Aortic valve calcification and stenosis can be assessed with echocardiography. Cerebral magnetic resonance imaging (MRI) depicts and quantifies morphological signs of hypoperfusion and vascular embolism, which is of special interest in patients with severe aortic stenosis. Furthermore, subjects who undergo TAVI are prone to suffer of clinically silent peri-procedural CVEs. A total of 119 patients referred to TAVI were investigated for aortic valve calcification using trans-esophageal echocardiography. Cerebral MRI prior to and immediate after implantation was performed in all patients using a dedicated scan protocol. Prior to TAVI, brain morphology was characterized. Post TAVI, brains were investigated for the onset of acute peri-procedural CVEs using diffusion weighted imaging (DWI). Seventy-eight patients (65.5%) revealed acute peri-procedural CVEs on MRI after TAVI with a favor of the left hemisphere (57.5%). The degree of valve calcification was associated with peri-procedural CVEs. Patients with a high WML burden had an increased risk for CVEs ((OR) 2.36 (95% CI: 1.09-5.15; P = 0.037)), especially when distributed periventricular ((OR: 3.27; 95% CI: 1.47-7.26; P = 0.0038)). In patients undergoing TAVI, the degree of aortic valve calcification and periventricular WML burden were correlated with acute peri-procedural CVEs. Future studies are needed to evaluate their independent value for the long-term clinical outcome.

Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Previous Major Gastrointestinal Bleeding (from the Amplatzer Cardiac Plug Multicenter Registry)

History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed. Patients with previous MGIB as indication for LAAO were compared with patients without previous MGIB. A total of 151 patients (14.4%) with previous MGIB were identified. Periprocedural major bleeding events were more frequent in patients with previous MGIB (4.0% vs 0.8%, p= 0.001). With an average follow-up of 1.3years, the observed annual rate of stroke/transient ischemic attack and major bleeding for patients with previous MGIB were 2.1% (61.4% relative reduction according to the Congestive Heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65-74, and Sex (female) [CHA2DS2-VASc] score) and 4.6% (20.1% relative reduction according to the expected rate based on the Hypertension, Abnormal renal/liver function (1 point each), Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs/alcohol concomitantly (1 point each) [HAS-BLED] score), respectively. In conclusion, in patients with non-valvular atrial fibrillation and previous MGIB, LAAO was associated with a low annual rate of stroke/transient ischemic attack. Periprocedural major bleeding events were more frequent in this specific population although the annual major bleeding rate showed a 20.1% relative risk reduction according to the HAS-BLED score.

Total Thrombus-formation Analysis System Predicts Periprocedural Bleeding Events in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention.

BackgroundPeriprocedural bleeding events are common after percutaneous coronary intervention. We evaluated the association of periprocedural bleeding events with thrombogenicity, which was measured quantitatively by the Total Thrombus‐formation Analysis System equipped with microchips and thrombogenic surfaces (collagen, platelet chip [PL]; collagen plus tissue factor, atheroma chip [AR]).Methods and ResultsBetween August 2013 and March 2016, 313 consecutive patients with coronary artery disease undergoing elective percutaneous coronary intervention were enrolled. They were divided into those with or without periprocedural bleeding events. We determined the bleeding events as composites of major bleeding events defined by the International Society on Thrombosis and Hemostasis and minor bleeding events (eg, minor hematoma, arteriovenous shunt and pseudoaneurysm). Blood samples obtained at percutaneous coronary intervention were analyzed for thrombus formation area under the curve (PL24‐AUC10 for PL chip; AR10‐AUC30 for AR chip) by the Total Thrombus‐formation Analysis System and P2Y12 reaction unit by the VerifyNow system. Periprocedural bleeding events occurred in 37 patients. PL24‐AUC10 levels were significantly lower in patients with such events than those without (P=0.002). Multiple logistic regression analyses showed association between low PL24‐AUC10 levels and periprocedural bleeding events (odds ratio, 2.71 [1.22–5.99]; P=0.01) and association between PL24‐AUC10 and periprocedural bleeding events in 176 patients of the femoral approach group (odds ratio, 2.88 [1.11–7.49]; P=0.03). However, PL24‐AUC10 levels in 127 patients of the radial approach group were not significantly different in patients with or without periprocedural bleeding events.ConclusionsPL24‐AUC10 measured by the Total Thrombus‐formation Analysis System is a potentially useful predictor of periprocedural bleeding events in coronary artery disease patients undergoing elective percutaneous coronary intervention.

Pretreatment with and ongoing use of omega-3 fatty acid ethyl esters reduce the slow-flow phenomenon and prevent in-stent restenosis in patients undergoing carotid artery stenting

ObjectiveCarotid artery stenting (CAS) is a less invasive alternative to carotid endarterectomy, but it is essential to prevent thromboembolic complications during CAS and to suppress in-stent restenosis (ISR) after CAS because of the relatively high risk of periprocedural and follow-up stroke events. Clinical trials have demonstrated the strong relationship of carotid plaque vulnerability with the subsequent risk of ipsilateral ischemic stroke and thromboembolic complications during CAS. Recent studies demonstrated that both low eicosapentaenoic acid (EPA) and low docosahexaenoic acid (DHA) levels were significantly associated with lipid-rich coronary and carotid plaques, but little is known about the effect of administration of omega-3 fatty acids (O-3FAs) containing EPA and DHA before and after CAS for stabilizing carotid plaque, preventing thromboembolic complications, and suppressing ISR. In this study, the efficacy of pretreatment with and ongoing daily use of O-3FA in addition to statin treatment was evaluated in patients undergoing CAS. MethodsThis study was a nonrandomized prospective trial with retrospective analysis of historical control data. From 2012 to 2015, there were 100 consecutive patients with hyperlipidemia undergoing CAS for carotid artery stenosis who were divided into two groups. Between 2012 and 2013 (control period), 47 patients were treated with standard statin therapy. Between 2014 and 2015 (O-3FA period), patients were treated with statin therapy and add-on oral O-3FA ethyl esters containing 750 mg/d DHA and 1860 mg/d EPA from 4 weeks before CAS, followed by ongoing daily use for at least 12 months. In all patients, the plaque morphology by virtual histology intravascular ultrasound, the incidence of new ipsilateral ischemic lesions on the day after CAS, the slow-flow phenomenon during CAS, and ISR within 12 months after CAS were compared between the periods. ResultsThe slow-flow phenomenon during CAS with filter-type embolic protection devices decreased in the O-3FA period (1 of 53 patients [2%]) compared with the control period (7 of 47 patients [15%]; P = .02). Furthermore, ISR for 12 months after CAS was significantly decreased in the O-3FA period (1 of 53 patients [2%]) compared with the control period (10 of 47 patients [21%]; P = .01). On virtual histology intravascular ultrasound analysis, the fibrofatty area was significantly smaller and the fibrous area was significantly greater in the O-3FA period. On multivariate logistic regression analysis, a low EPA/arachidonic acid ratio and a symptomatic lesion were the factors related to vulnerable plaque (P = .01 [odds ratio, 5.24; 95% confidence interval, 1.65-16.63] and P = .01 [odds ratio, 11.72; 95% confidence interval, 2.93-46.86], respectively). ConclusionsPretreatment with O-3FA reduces the slow-flow phenomenon generated by plaque vulnerability during CAS, and on-going daily use of O-3FA suppresses ISR after CAS.

A comparison of results of carotid endarterectomy in octogenarians and nonagenarians to younger patients from the Mid-America Vascular Study Group and the Society for Vascular Surgery Vascular Quality Initiative

ObjectiveCarotid endarterectomy (CEA) reduces stroke risk in selected patients. However, CEA risk profile may be different in older patients. We compared characteristics and outcomes of octogenarians and nonagenarians with those of younger patients. MethodsDeidentified data from CEA patients were obtained from the Society for Vascular Surgery Vascular Quality Initiative (VQI) database. Prior CEA, carotid artery stent, or combined CEA and coronary artery bypass were excluded, yielding 7390 CEAs in octogenarians and nonagenarians (≥80 years of age) and 35,303 CEAs in younger patients (<80 years of age). We compared post-CEA outcomes, including periprocedural cerebral ischemic events and death, and details such as operative time, bleeding, and return to surgery. ResultsOctogenarians and nonagenarians were more likely to have pre-CEA neurologic symptoms (51.4% vs 45.6%; P < .001) and to have never smoked (37.8% vs 22.0%; P < .001), and they were slightly more likely to have required urgent CEA (16.1% vs 13.4%; P < .001). Stenosis ≥70% was similar (octogenarians and nonagenarians, 94.2%; younger patients, 94.4%; P = .45). Perioperative ipsilateral neurologic events and ipsilateral stroke were slightly more common among octogenarians and nonagenarians (1.6% vs 1.1% [P < .001] and 1.2% vs 0.8% [P = .002]). Multivariate modeling (logistic regression) showed that pre-CEA neurologic symptoms (odds ratios, 1.35 [P = .005] and 1.42 [P = .007]), pre-CEA ipsilateral cortical ischemic event (odds ratios, 1.18 [P < .001] and 1.20 [P < .001]), and urgency (odds ratios, 1.75 [P < .001] and 1.67 [P < .001]) remained strong predictors of any ipsilateral neurologic event and any ipsilateral stroke, respectively. However, age ≥80 years remained a significant predictor of these outcomes (odds ratios, 1.37 [P = .003] and 1.44 [P = .004]). Kaplan-Meier estimated survival was lower for octogenarians and nonagenarians at 30 days and 1 year (98.6% vs 99.4% and 93.7% vs 97.0%; log-rank, P < .001). Age ≥80 years was also associated with a greater rate of discharge to other than home after CEA, a difference that was only partially explained by comorbidities in multivariate modeling. ConclusionsCEA was performed with low rates of perioperative neurologic events and mortality. Multivariate testing showed that the higher rate of neurologic complications in octogenarians and nonagenarians appeared partially related to symptomatic status and urgent surgery; but after adjusting for these factors, age ≥80 years still predicted a slightly higher rate. Periprocedural CEA outcomes appear similar in comparing older and younger patients, although longer term survival is lower for older patients, and older patients are at greater risk of discharge to other than home. CEA was associated with slightly higher risk of neurologic complications in older patients but may be considered appropriate for selected octogenarians and nonagenarians.

CRT-800.28 The CIN-IT Study: - Contrast Induced Nephropathy In Patients Undergoing Transcatheter Aortic Valve Replacement

Patients with chronic kidney disease have worse outcomes following TAVR (Transcatheter Aortic Valve Replacement). They are older, have more comorbidities and are exposed to significant volumes of contrast and risk for peri-procedural thromboembolic events. Identifying patients we can provide the