Periprocedural Adverse Events Research Articles

SPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT

IntroductionPersistent spine pain syndrome type 2 (PSPS2) represents a significant burden to the individual and society. Treatment options include revision surgery, stabilisation surgery of the spine, neuromodulation, analgesics and cognitive...

Steroid supplementation before minor oral surgical procedures in patients taking long-term glucocorticoids: A triple-blinded, randomized, placebo-controlled trial

BackgroundPatients undergoing long-term glucocorticoid therapy are administered additional glucocorticoids before minor dental procedures, although this is not supported by evidence. The authors designed this study to validate the hypothesis that routine blanket glucocorticoid supplementation is unnecessary during minor oral surgical procedures under local anesthesia. MethodsThe authors recruited 270 patients into 3 groups (1:1:1 allocation) from the dental outpatient department. Primary outcomes were changes in hemodynamic parameters and frequency of adverse events among the 3 groups. The secondary outcome was the association of preprocedural stress and procedural pain with periprocedural adverse events in the long-term glucocorticoid therapy group (groups I and II). ResultsNo clinically relevant changes in hemodynamic parameters among the 3 groups were found. The authors also found low periprocedural adverse events in all 3 groups combined (n = 1), so they did not explore the secondary outcomes further. ConclusionsAmong patients undergoing long-term glucocorticoid therapy for indications other than primary adrenal insufficiency, elective minor oral surgical procedures can be performed safely with only their daily dose of glucocorticoid when their medical conditions are optimized. Routine additional glucocorticoid supplementation appears unnecessary. The results of the study also revealed opportunities for value addition by means of integrating oral health care with medical follow-up for patients with multiple co-occurring medical conditions. Practical ImplicationsRoutine blanket glucocorticoid supplementation among patients taking a long-term glucocorticoid for indications other than primary adrenal insufficiency appears unnecessary before minor oral surgical procedures under local anesthesia. This clinical trial was registered at Clinical Trial Registry-India. The registration number is CTRI/2017/02/007779.

Impact of periprocedural major adverse events on 10-year mortality after revascularisation.

The long-term prognostic impact of a composite of periprocedural major adverse events (PMAE) following revascularisation for patients with complex coronary artery disease (CAD) has not yet been established. This study aimed to assess the impact on 10-year mortality of non-fatal PMAE following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Other objectives were to evaluate 1) whether PMAE affect mortality predicted by the SYNTAX score II 2020 (SSII-2020) and 2) whether optimal medical therapy (OMT) positively affects the prognosis of patients with non-fatal PMAE. The association between 10-year mortality and non-fatal PMAE occurring within 30 days of PCI or CABG in patients with three-vessel disease and/or left main disease enrolled in the SYNTAXES study was investigated. The main findings are that non-fatal PMAE occurred less frequently following PCI than CABG (11.2% vs 28.2%; p<0.001) and that non-fatal PMAE were an independent predictor of all-cause mortality in the first year post-procedure, but not at 5 or 10 years, in both treatment modalities. PMAE substantially alter the individual predictions of 10-year mortality by the SSII-2020. In patients with non-fatal PMAE, OMT may provide survival benefits during the first year post-procedure as well as in the long term. In patients with complex CAD, non-fatal PMAE were more common following CABG than PCI, but their prognostic impact was similar, being significant in the first year and then diminishing out to 10 years. Patients with non-fatal PMAE may therefore require more careful follow-up and additional preventive treatment in the first year post-procedure.

Periprocedural adverse events after revascularisation: the importance of getting off to a good start.

Periprocedural adverse events after revascularisation: the importance of getting off to a good start.

Patterns of Care and Outcomes of Ambulatory Endovascular Interventions in Lower Extremity Peripheral Arterial Disease

Lower extremity endovascular intervention (LE-EVI) is gaining popularity as the primary treatment modality for patients with symptomatic peripheral artery disease refractory to noninvasive management. We examined the contemporary patterns of care, regional variation, and outcomes of ambulatory LE-EVI in the United States. The National Ambulatory Surgery Sample was analyzed to identify 266,563 records with peripheral artery disease and LE-EVI between January 1, 2016 and December 31, 2017. The mean age of the study cohort was 68.9years and 40.5% were women. The majority of the endovascular interventions were performed at large (58.1%), urban teaching (64.1%), private not-for-profit (76.8%) centers, and the southern region accounted for most cases (43%). Periprocedural major adverse renal and cardiovascular events and other complications were 0.5% and 3.3%, respectively. Most patients (97.6%) were discharged home after the procedure. Age, female gender, uncontrolled hypertension, ischemic heart disease, heart failure, arrhythmia, chronic kidney disease, malnutrition, non-Medicare insurance, private for-profit, urban teaching facilities, and southern and midwest regions were associated with higher odds of major adverse renal and cardiovascular events. The mean charges per patient encounter were $56,500, with significant differences across various patient and facility characteristics. In conclusion, our study demonstrates the use, patterns of care, financial aspect, and overall safety of ambulatory LE-EVIs in a real-world setting.

Procedural Characteristics and Clinical Outcomes Associated with Chronic Total Occlusion Percutaneous Coronary Intervention in Patients with a History of Prior Coronary Artery Bypass Graft: A Meta-Analysis.

Owing to advances in procedural techniques and the training of interventional staff in catheterization labs, recent work has demonstrated the safety of percutaneous coronary intervention (PCI) as a treatment for patients suffering from chronic total occlusion (CTO). However, there has been little research focused on systematic comparisons of PCI outcomes in CTO patients that did or did not exhibit a history of previous coronary artery bypass grafting (CABG). Electronic databases were systematically searched for all studies comparing CTO-PCI outcomes for patients with and without a history of CABG, with event rates subsequently being compared via random-effects models with forest plots and odds ratios with 95% confidence intervals (CI), owing to the assumption of between-studies heterogeneity. In total, 8 observational studies enrolling 13,509 CTO patients were identified, including 3389 and 10,120 patients with and without a history of prior CABG, respectively. Patients were enrolled in these studies from 1999-2018. Pooled analyses indicated that CABG history was not linked to a lower proportion of radial access 24 (95% CI 0.52-1.03, p = 0.08), and a prior CABG history was linked to a greater contrast volume (95% CI 0.12-0.44, p 0.001), higher radiation dose (95% CI 0.27-0.40, p 0.001), longer fluoroscopy time (95% CI 0.42-0.61, p 0.001), longer procedural time (95% CI 0.38-0.64, p 0.001), a higher number of implanted stents (95% CI 0.41-0.60, p 0.001), longer total stent length (95% CI 0.21-0.60, p 0.001), higher technical failure rates (95% CI 1.46-1.85, p 0.001), and higher rates of procedural failure (95% CI 1.42-1.79, p 0.001). The in-hospital mortality (95% CI 1.50-4.03, p 0.001) and periprocedural mortality (95% CI 1.63-3.73, p 0.001) of patients with a history of CABG were also higher. While stroke incidence was comparable in both groups (95% CI 0.80-4.47, p = 0.15), periprocedural major adverse cardiovascular and cerebrovascular events (MACCE) rates were significantly higher among patients exhibiting a history of CABG (95% CI 1.66-2.94, p 0.001). These results suggest that CTO-PCI procedures may be more challenging and associated with lower rates of success in CABG patients relative to procedures performed in patients without any history of CABG. Moreover, in-hospital outcomes including MACCE and mortality were worse for patients that had undergone prior CABG.

Abstract P183: Systolic Dysfunction is Associated With Increased Occurrence and Worse Outcomes of Periprocedural Cardiovascular Adverse Events After Transcatheter Aortic Valve Replacement

Background: Transcatheter aortic valve replacement (TAVR) rate continues to ascend nationwide as per the transcatheter valve therapy registry, and this calls for even better strategies to aim for negligible complication rates. Current practice relies on surgically derived risk models. We set out to assess the impact of systolic dysfunction on perioperative cardiovascular adverse events. Hypothesis: The presence of systolic dysfunction is associated with increased frequency and poorer outcomes of periprocedural cardiovascular adverse events among patients undergoing TAVR. Method: A retrospective cohort study was designed using data obtained from the 2016 to 2018 combined National Inpatient Sample (NIS) database. The current procedural terminology (CPT) Codes of ICD-10 were used to identify patients admitted for TAVR. They were then dichotomized into two cohorts based on the presence of systolic dysfunction. Primary outcomes were death, length of stay, total charge, composite of all cardiovascular perioperative adverse events and composite of all cardiovascular perioperative adverse events and death. Secondary outcomes were individual cardiovascular perioperative adverse events for all TAVR admissions and subsequently for patients with post-TAVR cardiac dysfunction. Multivariate linear and logistic regressions were used to adjust for confounders. Results: There was a total of 145,640 admissions for TAVR among whom were 16,980 with systolic dysfunction. Details of outcomes of study are summarized in table 1 below. Conclusion: Among inpatients who underwent TAVR, systolic dysfunction is associated with higher odds of mortality, composite of all cardiovascular adverse events and composite of death and all cardiovascular adverse events. There was increased odds of periprocedural cardiac dysfunction, particularly with increased cardiogenic shock. There was increased length of stay and total charge.

Impact of Periprocedural Adverse Events After PCI and CABG on 5-Year Mortality: The EXCEL Trial

BackgroundThe relative risks for different periprocedural major adverse events (MAE) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) on subsequent mortality have not been described. ObjectivesThe aim of this study was to assess the association between periprocedural MAE occurring within 30 days postprocedure and early and late mortality after left main coronary artery revascularization by PCI and CABG. MethodsIn the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, patients with left main disease were randomized to PCI vs CABG. The associations between 12 prespecified nonfatal MAE and subsequent 5-year all-cause and cardiovascular death in 1,858 patients were examined using logistic regression. ResultsOne or more nonfatal MAE occurred in 111 of 935 patients (11.9%) after PCI and 419 of 923 patients (45.4%) after CABG (P < 0.0001). Patients with MAE were older and had more baseline comorbidities. Within 5 years, all-cause death occurred in 117 and 87 patients after PCI and CABG, respectively. Experiencing an MAE was a strong independent predictor of 5-year mortality after both PCI (adjusted OR: 4.61; 95% CI: 2.71-7.82) and CABG (adjusted OR: 3.25; 95% CI: 1.95-5.41). These associations were present within the first 30 days and between 30 days and 5 years postprocedure. Major or minor bleeding with blood transfusion ≥2 U was an independent predictor of 5-year mortality after both procedures. Stroke, unplanned revascularization for ischemia, and renal failure were significantly associated with mortality only after CABG. ConclusionsIn the EXCEL trial, nonfatal periprocedural MAE were strongly associated with early and late mortality after both PCI and CABG for left main disease.

Mechanical thrombectomy of large vessel occlusion using adjustable vs. self-expanding stent-retriever-Comparison of Tigertriever device with stent-like stent-retrievers: A propensity score analysis.

Stent-retrievers used for mechanical thrombectomy are self-expanding tubular stent-like devices with modified mesh structures for clot removal. Tigertriever is designed to provide manual control of its diameter and curvature. A retrospective single-center study was performed to compare Tigertriever with SolitaireX and pRESET (stent-like stent-retrievers group) using propensity score analysis. Patients treated in a comprehensive stroke center due to large vessel occlusion between January 2016 and August 2021 were evaluated. Baseline characteristics and treatment results were compared between these groups before and after pair matching. There were 140 patients (60 in Tigertriever and 80 in the stent-like stent-retriever group). In propensity score analysis, 52 matched pairs were selected in Tigertriever and stent-like stent-retriever groups. The Tigertriever group had a better successful first pass revascularization rate [46 vs. 23%, OR (95% CI): 1.7 (1.1-2.9), p = 0.013] and 14-min shorter groin-to-revascularization time (51 vs. 65 min. p = 0.017). There were no significant differences between Tigertriever and stent-like stent-retriever groups in the following: favorable mRS 3 months, favorable recanalization rate, and symptomatic intracerebral hemorrhages. There were no observed periprocedural adverse events related to Tigertriever, SolitaireX, or pRESET. Tigertriever had a significantly better successful first pass revascularization rate and shorter groin-to-revascularization time in the analysis done before and after propensity score matching with stent-like stent-retrievers. Tigertriever is comparable to stent-like stent-retrievers regarding mortality at 3 months, favorable mRS at 3 months, favorable recanalization rate, or symptomatic cerebral hemorrhagic events.

1108 PERI-PROCEDURAL COMPLICATIONS AND LONG-TERM OUTCOMES IN ATRIAL FIBRILLATION PATIENTS STRATIFIED FOR CHRONIC KIDNEY DISEASE SEVERITY UNDERGOING LEFT ATRIAL APPENDAGE OCCLUSION: RESULTS FROM AN INTERNATIONAL, MULTICENTRE REGISTRY

Abstract Background Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thromboembolic events. CKD concomitantly contributes to several pathophysiological changes predisposing towards a pro-haemorrhagic state. Objective To evaluate the impact of kidney function on peri-procedural complications and clinical outcomes in AF patients undergoing left atrial appendage occlusion (LAAO) with a Watchman device. Methods 2124 consecutive AF patients undergoing Watchman implantation at 8 different centers were categorized into CKD stage 1+2 (n=1089), CKD stage 3 (n=796), CKD stage 4 (n=170), CKD stage 5 (n=69) based on the estimated glomerular filtration rate at baseline. The primary efficacy endpoint included a composite of cardiovascular (CV) mortality, stroke, transient ischemic attack, peripheral thromboembolism (TE), and major bleeding. Results A non-significant higher incidence of major peri-procedural adverse events (1.7% vs. 2.3% vs. 4.1% vs. 4.3%) was observed with worsening baseline kidney function (p=0.14). The mean follow-up period was 13 ± 7 months [2226 patient-years (PY)]. In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank p-value= 0.04), CKD stage 4 (log-rank p-value= 0.01), and CKD stage 5 (log-rank p-value= 0.001). A non-significant increase in event rates for stroke/TIA and clinically relevant bleeding was observed among the four groups. LAAO led to a TE risk reduction of 72%, 66%, 62%, and 41% in each group. The relative risk reduction in the incidence of major bleeding was 58%, 44%, 51%, and 52%, respectively. Conclusion Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative risk reduction in the incidence of TE and major bleeding was consistent across CKD groups, irrespective of the very different risk profiles at baseline.

Use of Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention

The use of mechanical circulatory support (MCS) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We analyzed the clinical and angiographic characteristics, and procedural outcomes of 7,171 CTO PCIs performed between 2012 and 2021 at 35 international centers. Mean age was 64.5 ± 10 years, mean left ventricular ejection fraction was 50 ± 13%. MCS was used in 4.5%, prophylactically in 78.7%, and urgently in 21.3%. The most common type of MCS overall was Impella CP (Abiomed) (55.5%), followed by intra-aortic balloon pump (14.8%) and TandemHeart (LivaNova Inc.) (10.0%). Prophylactic MCS patients were more likely to have diabetes mellitus (55% vs 42%, p <0.001) and had more complex lesions compared with cases without prophylactic MCS (Japan-CTO score: 2.80 ± 1.22 vs 2.39 ± 1.27, p <0.001). Cases with prophylactic MCS had similar technical (86% vs 87%, p=0.643) but lower procedural (80% vs 86%, p=0.028) success rates and higher rates of periprocedural major cardiac adverse events compared with no prophylactic MCS use (6.55% vs 1.68%, p <0.001). Urgent MCS use was associated with lower technical (68% vs 87%, p <0.001) and procedural (39% vs 86%, p <0.001) success rates and higher major cardiac adverse events compared with no-MCS use (32.26% vs 1.68%, p <0.001). The differences persisted in multivariable analyses. In summary, in this contemporary multicenter registry, MCS was used in 4.5% of CTO PCIs, mostly prophylactically (78.7%). Elective MCS cases had similar technical success but a higher risk of complications. Urgent MCS cases had lower technical and procedural success and higher periprocedural major complication rates.

Novel application of intravascular lithotripsy in stent under-expansion: A single-center experience.

Stent under-expansion due to calcification is associated with a less durable result. The development of intravascular lithotripsy (IVL) has provided clinicians with a readily available, simple-to-use treatment option for coronary calcification, but the use of IVL within a previously stented segment is currently off-license. There are, however, developing data suggesting that the use of IVL can be an effective treatment option for patients with calcific stent under-expansion. This was a single-center study of all patients treated with IVL for calcific stent under-expansion between January 2019 and June 2021. The impact of IVL on quantitative coronary angiography (QCA) stenosis and on the minimal stent area (MSA) derived from intracoronary imaging were recorded. The presence of periprocedural complications and adverse cardiovascular events was obtained from the clinical record during the study timeframe. Thirty-nine patients underwent IVL for calcific stent under-expansion during the study time frame with one patient treated with more than one lesion in the same session. In all lesions, there was an improvement in the QCA stenosis with 37 (92.5%) having a residual stenosis of ≤30%. The mean QCA stenosis pre-IVL was 68 ± 21% and following IVL the mean QCA was 18 ± 9% (p < 0.001). In all lesions, there was an improvement in the MSA, with 26 (92.9%) achieving an MSA of more than 4.5 mm2. The mean MSA pre-IVL was 3.88 ± 1.51 mm2 and following IVL the mean MSA was 7.41 ± 2.34 mm2 (p < 0.001). There were no major procedural complications. Over a mean follow-up of 506 ± 277 days, one patient died from ventricular arrhythmia but there were no other major adverse cardiovascular events. This single-center study demonstrates that IVL is a safe and effective treatment for calcific stent under-expansion with good medium-term results.

Maybe asymptomatic carotid disease is not as benign as we think.

In this issue of JVS, Turner et al1Turner A.D. Zhu J. Rao A. Ting W. Han D. Tadros R. et al.Carotid stenosis patients with a remote history of cerebrovascular events have increased risk of major adverse events over asymptomatic patients.J Vasc Surg. 2022; 76: 1625-1632Google Scholar provide some additional insight into the impact of a remote history of cerebrovascular events as a marker for increased periprocedural adverse events after carotid stenting. The default definition of “asymptomatic” extracranial carotid disease is the absence of clinical signs and symptoms of a transient ischemic attack or stroke. As this report shows, although most asymptomatic patients are truly asymptomatic, a subset do indeed have a prior history of a neurologic event that occurred more than 180 days before an intervention but are still typically categorized as asymptomatic. This current report demonstrates that at least among patients treated with carotid stenting (transfemoral vs transcarotid), the periprocedural outcomes more closely resemble the symptomatic rather than the asymptomatic patient population. For years, we have tried a variety of imaging techniques to identify the unstable asymptomatic plaque including computed tomographic evaluation, magnetic resonance plaque characterization, ultrasound gray scale median, and transcranial Doppler.2Kakkos S.K. Griffin M.B. Nicolaides A.N. Kyriacou E. Sabetai M.M. Tegos T. et al.Asymptomatic Carotid Stenosis and Risk of Stroke (ACSRS) study group. The size of juxtaluminal hypoechoic area in ultrasound images of asymptomatic carotid plaques predicts the occurrence of stroke.J Vasc Surg. 2013; 57 (discussion: 617-8): 609-618.e1Abstract Full Text Full Text PDF PubMed Scopus (127) Google Scholar,3Saba L. Antignani P.L. Gupta A. Cau R. Paraskevas K.I. Poredos P. et al.International Union of Angiology (IUA) consensus paper on imaging strategies in atherosclerotic carotid artery imaging: from basic strategies to advanced approaches.Atherosclerosis. 2022; 354: 23-40Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Unfortunately, none are broadly recognized as an accurate predictor. In my institution, transcranial Doppler is used quite frequently by the stroke neurologists, yet it has not made a noticeable impact on the current treatment algorithm for most patients. Hopefully, upcoming prospective studies such as the Carotid Artery Multimodality imaging Prognostic study may provide more valuable insight of the unstable asymptomatic plaque with contemporary imaging techniques.4Gargani L. Baldini M. Berchiolli R. Bort I.R. Casolo G. Chiappino D. et al.Detecting the vulnerable carotid plaque: the Carotid Artery Multimodality imaging Prognostic study design.J Cardiovasc Med (Hagerstown). 2022; 23: 466-473Crossref Scopus (1) Google Scholar Although the current report demonstrates improved outcomes among the transcarotid treated patient population vs transfemoral stenting using the Vascular Quality Initiative database, some concerns exist in regard to the data quality and sample size. Important unknowns include adherence and implementation of currently accepted optimal medical therapy, operator expertise, and objective neurologic assessment before and after the procedure. Nevertheless, the important message is that asymptomatic patients with any prior history of a remote neurologic event tend to have less favorable outcomes as compared those with no prior history of a neurologic event, and this information should be taken into consideration as part of the treatment algorithm. The opinions or views expressed in this commentary are those of the authors and do not necessarily reflect the opinions or recommendations of the Journal of Vascular Surgery or the Society for Vascular Surgery. Carotid stenosis patients with a remote history of cerebrovascular events have increased risk of major adverse events over asymptomatic patientsJournal of Vascular SurgeryVol. 76Issue 6PreviewAsymptomatic patients with a remote history of transient ischemic attack (TIA) or stroke are not well studied as a separate population from asymptomatic patients with no prior history of TIA or stroke. We compared in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) among symptomatic patients, patients with a remote history of neurologic symptoms, and asymptomatic patients. Full-Text PDF

The Safety and Long-Term Efficacy of Carotid Artery Stenting: An All-Comers Registry.

Background Carotid artery stenting (CAS) has emerged as a less invasive alternative to carotid endarterectomy (CEA) for the prevention of future cerebrovascular events in patients with carotid artery stenosis. Despite multiple randomized controlled trials (RCTs) comparing CAS and CEA for carotid disease, real-world data outside the rigorous environment of trials is scarce. Methods The present study is a prospectiveobservational study conducted at a tertiary care center, wherein all patients who underwent CAS between January 2007 and December 2019 were included. All patients were followed up for one year of the last enrolled patient at an interval of one, six, and 12 months and then yearly thereafter. The primary composite outcome was defined as a combination of periprocedural (until 30 days of procedure) major adverse cardiac and cerebrovascular events (MACCEs) and the long-term incidence of ipsilateralstroke. The secondary outcome included the rate of restenosis. Results A total of 115 patients (86 males and 29females) (147 lesions) who underwent CAS between 2007 and 2019 were followed up for a median of 80.5 months. Seventy-seven (67.27%) patients were symptomatic, and 38/115 (33%) were asymptomatic. PeriproceduralMACCEs were noted in six patients, and four patients had ipsilateral stroke on long-term follow-up; hence, the primary composite outcome was observed in 10 (8.7%) patients. Higher age was found to be significantly associated with the primary composite outcome (p-value = 0.005). Five (4.34%) patients were lost to follow-up, while four (3.48%) patients developed restenosis. Conclusion CAS is a safe and less invasive intervention in patients with significant carotid artery stenosis and is equally effective in preventing future strokes. The incidence of primary outcome rises with an increase in age.

Initial experience, feasibility, and technical development with an electromagnetic navigation assistance in percutaneous pelvic bone cementoplasty: retrospective analysis.

To assess the feasibility and technical outcomes of pelvic bone cementoplasty using an electromagnetic navigation system (EMNS) in standard practice. Monocentric retrospective study of all consecutive patients treated with cementoplasty or reinforced cementoplasty of the pelvic bone with EMNS-assisted procedures. The endpoints were periprocedural adverse events, needle repositioning rates, procedure duration, and radiation exposure. A detailed description of the technical steps is provided. Thirty-three patients (68 years ± 10) were treated between February 2016 and February 2020. Needle repositioning was required for 1/33 patients (3%). The main minor technical adverse event was soft tissue PMMA cement leaks. No major adverse event was noted. The median number of CT acquisitions throughout the procedures was 4 (range: 2 to 8). Radiation exposure and mean procedure duration are provided. Electromagnetic navigation system-assisted percutaneous interventions for the pelvic bone are feasible and lead to low rates of minor technical adverse events and needle repositioning. Procedure duration and radiation exposure were low. • Initial experience for 33 patients treated with an electromagnetic navigation assistance for pelvic cementoplasty shows feasibility and safety. • The use of an electromagnetic navigation system does not expose to high procedure duration or radiation exposure. • The system is efficient in assisting the radiologist for extra-axial planes in challenging approaches.

Combined atrial fibrillation ablation and left atrial appendage closure: Watchman vs. LAmbre devices

Left atrial appendage closure (LAAC) combined with radiofrequency catheter ablation is an emerging one-stop hybrid procedure for non-valvular atrial fibrillation (AF). This study was performed to compare the efficacy and safety of the Watchman device vs. the LAmbre device for this combined procedure. Two hundred and thirty two patients with AF who underwent the combined procedure were enrolled and divided into two subgroups depending on the device choice: the Watchman-combined group (n = 118) and the LAmbre-combined group (n = 114). The periprocedural and follow-up adverse events in both groups were documented. The mean CHA2DS2-VASc score and HAS-BLED score in the Watchman-combined group and LAmbre-combined group were 3.7 ± 1.5 vs. 3.8 ± 1.5 and 2.5 ± 1.1 vs. 2.3 ± 1.1, respectively (all P > 0.05). Successful LAAC was achieved in all patients. The rate of major periprocedural complications and AF recurrence at 6 months post-procedure were similar between the Watchman-combined group and LAmbre-combined group (0.8 vs. 0.9%, P = 1.00; 22.0 vs. 15.8%, P = 0.23). During 2.6 ±0 .7 vs.1.6 ± 1.6 years follow-up, the rate of major clinical adverse events, including stroke and major bleeding, were comparable between the Watchman-combined group and the LAmbre-combined group (2.6 vs. 1.1% per 100 patient-years, P = 0.33). The intraprocedural peri-device leakage (PDL) rate was similar between the Watchman-combined group and the LAmbre-combined group (5.1 vs. 6.1%, P = 0.73), but the PDL rate was significantly higher at 3-6 months transesophageal echocardiography (TEE) follow-up than the intraprocedural PDL rate in both groups (21.6 vs. 5.1%; 36.6 vs. 6.1%, respectively), with a more obvious increase in minimal PDL rate in the LAmbre-combined group than the Watchman-combined group (36.6 vs. 21.6%, P < 0.05). The Watchman and LAmbre devices were comparable in efficacy and safety for the combined procedure. The minimal PDL rate at short-term TEE follow-up was higher in the LAmbre-combined group than the Watchman-combined group.

In hospital outcomes among diabetics undergoing transcarotid artery revascularisation vs transfemoral carotid artery stenting &amp; carotid endarterectomy

Abstract Background Transcarotid artery revascularisation (TCAR) is a novel procedure to intervene on carotid artery stenosis. It has previously shown to have lower rates of periprocedural adverse events compared to transfemoral carotid artery stenting (TFCAS) and carotid endartectomy (CEA). To date, no study has examined outcomes among diabetics undergoing TCAR compared to TFCAS and CEA. Purpose We sought to determine the rates of adverse periprocedural outcomes related to TCAR, TFCAS and CEA in diabetics. Methods The Vascular Quality Initiative Database was queried for all patients from March 2009 to April 2021 for diabetic patients undergoing carotid artery revascularisation via TCAR, TFCAS or CEA. Baseline demographic information as well as periprocedural outcomes were obtained. Results A total of 57,716 diabetic patients underwent carotid artery revascularisation. Of these 11.3% underwent TCAR (n=6569), 8.1% (n=4703) underwent TFCAS, and 80.4% (n=46,444) underwent CEA. 39% (n=22,528) were female and 87.3% (n=50,377) were white. Compared to TFCAS, TCAR demonstrated lower rates of stroke (1.6% vs 2.2%, p=0.026), stroke/transient ischemic attack (2.2% vs 3.0%, p&amp;lt;0.001), and death (0.4% vs 1.3%, p&amp;lt;0.001) but remained higher than CEA for both stroke (1.6% vs 1.3%), stroke/TIA (2.2% vs 1.9%) and death (0.4% vs 0.3%). Conclusions TCAR appears to be a safe revascularisation procedure for carotid artery stenosis with lower rates of stroke, stroke/TIA, and death in diabetics compared to TFCAS. However, rates remain higher than CEA. TCAR may thus be a viable alternative in diabetics who otherwise would be poor candidates for revascularisation via CEA. Funding Acknowledgement Type of funding sources: None.

Long-term outcomes following transcatheter pulmonary valve implantation with the sapien 3 valve: an international multicentre registry

Abstract Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract dysfunction related to congenital heart disease. Long-term outcomes following TPVI with the new-generation SAPIEN 3 valve are not well documented. Purpose We investigated mid-term outcomes in a large cohort of patients who underwent TPVI using the SAPIEN 3 valve. Methods We retrospectively analysed data from a multicentre observational registry of patients who underwent TPVI with SAPIEN 3 in 30 centres in 12 countries from Europe, the Middle East, and Canada. Patient-related, procedural, and mid-term-outcome data were assessed. Results We obtained data for 713 patients treated in 2014–2021. Number of procedures performed among centres varied from 1 to 190 with a median of 15. Median age was 29.4-year-old [19.0–42.8]. The most common underlying diagnosis was cono-truncal defect (68.9%), with a native or patched right-ventricular outflow tract, a bioprosthetic valve, a homograft and a conduit, in 50.8%, 19.6%, 16.5% and 13.2% patients, respectively. Pre-stenting was performed in 74.8% patients. The 20-mm, 23-mm, 26-mm, and 29-mm valves were used in 0.4%, 28.2%, 31.2%, and 40.2% of patients, respectively. Valve implantation was successful in 98.6% patients. Life-threatening peri-procedural adverse events occurred in 3.7% patients, including 0.6% peri-procedural death. Median follow-up was 1.4 years (maximum, 5.9 years; 1160 patient-years), At last follow-up, pulmonary regurgitation grade 2, 3 and 4 was noted in 6.9%, 0.9% and 0.0% patients, respectively. Median maximal gradient at last follow-up was 18 mmHg. Six patients experienced infective endocarditis (0.5 per 100 patient-years) of whom 1 died and 2 required pulmonary valve replacement. Nine patients (0.8 per 100 patient-years) had secondary pulmonary valve replacement (including 2 by valve-in-valve TPVI; 7 patients had 23-mm and 2 had 26-mm valves). Four patients experienced pulmonary valve thrombosis (0.6 per 100 patient-year) of whom one died and 3 resolved under anticoagulation therapy. Cumulative incidences of infective endocarditis, secondary pulmonary valve replacement and valve thrombosis were 0.7%, 1.3% and 1.3%; 0.4%, 1.3% and 4.6%; 0.5%, 0.5% and 0.8% at 1, 3 and 5 years after TPVI respectively. Conclusion TPVI with the SAPIEN 3 valve was feasible and safe in a wide range of patients with congenital heart defects, most of whom had large native right-ventricular outflow tracts. Mid-term outcomes were favourable. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): The study is promoted and financially supported by a Research grant of the Groupe Hospitalier Paris Saint Joseph

Coronary Microcirculatory Function Indicated by Coronary Angiography-Derived Index of Microvascular Resistance in Patients Undergoing Rotational Atherectomy.

There are scarce published data reporting the effect of rotational atherectomy (RA) on coronary microcirculation function. We aimed to evaluate coronary microcirculation function indicated by the coronary angiography-derived index of microvascular resistance (caIMR) in patients undergoing RA. RA procedures between January 2013 and December 2021 were retrospectively analyzed. We investigated coronary microcirculation function indicated by caIMR as well as peri-procedural adverse events among the study population. All caIMR measurements were performed using a FlashAngio system. The primary outcome was a composite of post-RA thrombolysis in myocardial infarction (TIMI) flow grade 3 in the target vessel, myocardial injury, procedure-related myocardial infarction, and cardiac death during hospitalization. A total of 155 RA procedures were analyzed. The post-RA caIMRs were significantly higher than pre-RA caIMRs in the target vessels (16.0 7.0 vs. 14.5 7.5, p = 0.029). Patients with post-RA caIMR 25 accounted for nearly 12% of those with pre-RA caIMR 25. Patients with post-RA thrombolysis in myocardial infarction (TIMI) flow grade 3 had a significantly higher pre-RA caIMR (23.5 10.2 vs. 13.7 6.6, p = 0.005), and the proportion of patients with pre-RA caIMR 25 in the group with TIMI flow grade 3 was greater (61.5% vs. 38.5%, p 0.001) than that in the group with TIMI flow grade of 3. Maximum RA time of each pass (odds ratio: 1.127, 95% confidence interval: 1.025-1.239, p = 0.014) and pre-RA caIMR 25 (odds ratio: 3.254, 95% confidence interval: 1.054-10.048, p = 0.040) were identified to be the independent predictors of the primary outcome for patients who underwent RA. There were significant changes in the coronary microcirculation function of the target vessels after receiving RA as indicated by increased post-RA caIMR compared to pre-RA caIMR. Patients with baseline coronary microcirculatory dysfunction were more likely to have post-RA TIMI flow grade 3, whereas those with pre-RA caIMR 25 experienced worse outcomes.

Immediate outcomes after transcatheter atrial septal defect closure by Amplatzer septal occluder in a large single centre cohort: The ASOlong study

Transcatheter closure of ostium secundum atrial septal defects (ASDs) with Amplatzer septal occluder (ASO) is the preferred technique when anatomically feasible. New devices, reported to be softer or with new design have been developed aiming to reduce the risk of adverse events. We aimed to assess the procedural outcomes after transcatheter closure of ASD with the ASO device in a large single centre registry including consecutively all children and adults ( n = 2280, median age, 27 years [11; 49]; weight, 56 kg [32; 70]) from 1998 to 2021 (ASOlong registry). Most patients had balloon ASD sizing using the pull-through technique. Since 2005, nearly all procedures were guided using transthoracic echocardiography allowing procedures under local anesthesia in older children and adults. In four (0.2%) patients, ASD was closed from a jugular approach. Median ASO size was 22 mm [18; 28]. ASD closure was obtained with two and three devices in 71 and 1 cases respectively. Device/weight ratio was 0.4 [0.3–0.6], with a ratio ≥ 1.5 in 25 children (0.1%). Overall procedural success rate was 97.1% (95% CI: 96.4–97.8%) underestimated by patients with ASD considered not eligible after balloon calibration only. Device migration occurred in 17 (0.7%) patients successfully retried transcatheter in 13 cases and surgically in 4. No death was observed. Major peri-procedural adverse events occurred in 7 (0.3% 95% CI: 0.1–0.6) patients including 4 repaired arteriovenous fistulas. Life-threatening adverse events occurred in 3 patients (2 acute aortic erosion with haemopericardium, on day 2 after catheterization and 1 sigmoid colon dissection of unclear mechanism, requiring emergency surgery). There was a trend toward a higher rate of major events among children with device/weight ratio ≥ 1.5 (4.0% versus 0.4%, P = 0.1). Transcatheter ASD closure using ASO is efficient in a large spectrum of patients. Long-term outcomes are awaited from this study.