Periprocedural Death Research Articles

Young Patients Undergoing Carotid Endarterectomy Have Increased Rates of Recurrent Disease and Late Neurologic Events

Young Patients Undergoing Carotid Endarterectomy Have Increased Rates of Recurrent Disease and Late Neurologic Events

Disparities in transvenous lead extraction in young adults

Adults with cardiac implantable electronic devices (CIEDs) implanted at an early age constitute a specific group of patients undergoing transvenous lead extraction (TLE). The aim of this study is to assess safety and effectiveness of TLE in young adults. A comparative analysis of two groups of patients undergoing transvenous lead extraction was performed: 126 adults who were 19–29 years old at their first CIED implantation (early adulthood) and 2659 adults who were > 40 years of age at first CIED implantation and < 80 years of age at the time of TLE (middle-age/older adulthood). CIED-dependent risk factors were more common in young adults, especially longer implant duration (169.7 vs. 94.0 months). Moreover younger age of patients at first implantation, regardless of the dwell lead time, is a factor contributing to the greater development of connective tissue proliferation on the leads (OR 2.587; p < 0.001) and adhesions of the leads with the heart structures (OR 3.322; p < 0.001), which translates into worse TLE results in this group of patients. The complexity of procedures and major complications were more common in younger group (7.1 vs. 2.0%; p < 0.001), including hemopericardium (4.8 vs 1.3; p = 0.006) and TLE-induced tricuspid valve damage (3.2 vs.0.3%; p < 0.001). Among middle-aged/older adults, there were 7 periprocedural deaths: 6 related to the TLE procedure and one associated with indications for lead removal. No fatal complications of TLE were reported in young adults despite the above-mentioned differences (periprocedural mortality rate was comparable in study groups 0.3% vs 0.0%; p = 0.739). Predictors of TLE-associated major complications and procedure complexity were more likely in young adults compared with patients aged > 40 to < 80 years. In younger aged patients prolonged extraction duration and higher procedure complexity were combined with a greater need for second line tools. Both major and minor complications were more frequent in young adults, with hemopericardium and tricuspid valve damage being predominant.

ELECTRa Registry Outcome Score (EROS): validation in a single center population

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The ELECTRa Registry Outcome Score (EROS) was developed to identify patients at increased transvenous lead extraction (TLE) risk Purpose Aim of the study is to explore the efficiency of EROS for stratifying patients undergoing TLE. Methods We performed a retrospective analysis of 1293 patients who underwent to TLE in our center. We performed extraction procedures with manual traction or mechanical dilatation. We calculated EROS, and we divided patients into 3 groups depending on the EROS class. For this purpose, we made statistical analysis and comparison between EROS 1+2 vs. EROS 3 groups. We used an X2 for among-group comparisons or Fisher’s exact test if the expected cell count was less than five. Results Our analysis included 1293 patients. EROS-1 counted 726 patients (56,1%), EROS-2 367 (28,4%) patients and EROS-3 200 (15,5%) patients. There was no statistical difference in peri-procedural death between EROS-1+2 and EROS-3 (0.18% vs 1.50%, p=0.134). Major complications (0.82% vs. 3.00%, p=0.014), minor complications (3.11% vs. 6.50%, p=0.019) and use of internal jugular approach (6.13% vs. 14.50%, p&amp;lt;0.001) was significantly higher in EROS 3 patients. Conclusion EROS effectively separates patients at higher risk of complications. Use of internal jugular approach was significantly higher in EROS 3 patients.

Percutaneous Pulmonary Angioplasty for Patients With Takayasu Arteritis and Pulmonary Hypertension

BackgroundPercutaneous transluminal pulmonary angioplasty (PTPA) is a treatment modality for chronic thromboembolic pulmonary hypertension, but whether it can be applied to Takayasu arteritis–associated pulmonary hypertension (TA-PH), another chronic obstructive pulmonary vascular disease, remains unclear. ObjectivesThis study sought to investigate the efficacy and safety of PTPA for TA-PH. MethodsBetween January 1, 2016, and December 31, 2019, a total of 50 patients with TA-PH who completed the PTPA procedure (the PTPA group) and 21 patients who refused the PTPA procedure (the non-PTPA group) were prospectively enrolled in this cohort study. The primary outcome was all-cause mortality. The safety outcomes included PTPA procedure-related complications. ResultsBaseline characteristics and medical therapies were similar between the PTPA group and the non-PTPA group. During a mean follow-up time of 37 ± 14 months, deaths occurred in 3 patients (6.0%) in the PTPA group and 6 patients (28.6%) in the non-PTPA group, contributing to the 3-year survival rate of 93.7% in the PTPA group and 76.2% in the non-PTPA group (P = 0.0096 for log-rank test). The Cox regression model showed that PTPA was associated with a significantly reduced hazard of all-cause mortality in TA-PH patients (HR: 0.18; 95% CI: 0.05-0.73; P = 0.017). No periprocedural death occurred. Severe complications requiring noninvasive positive pressure ventilation occurred in only 1 of 150 total sessions (0.7%). ConclusionsPTPA tended to be associated with a reduced risk of all-cause mortality with acceptable safety profiles and seemed to be a promising therapeutic option for TA-PH patients.

Preprocedural and procedural variables that predict new-onset conduction disturbances after transcatheter aortic valve replacement

BackgroundConduction disturbances are a common complication after transcatheter aortic valve replacement (TAVR). The aim of this study was to investigate the preprocedural and procedural variables that predict new-onset conduction disturbances post-TAVR (hereafter CD/CDs).MethodsConsecutive patients who underwent TAVR during December 2009–March 2021 at the Faculty of Medicine Siriraj Hospital, Mahidol University—Thailand’s largest national tertiary referral center—were enrolled. Patients with prior implantation of a cardiac device, periprocedural death, or unsuccessful procedure were excluded. Clinical and electrocardiographic data, preprocedural imaging, including membranous septum (MS) length, and procedural variables, including implantation depth (ID), were analyzed. CD was defined as new left or right bundle branch block, significant intraventricular conduction disturbance with QRS interval ≥ 120 ms, new high-grade atrioventricular block, or complete heart block. Multivariate binary logistic analysis and receiver operating characteristic (ROC) curve analysis were used to identify independent predictors and the optimal ∆MSID (difference between the MS length and ID) cutoff value, respectively.ResultsA total of 124 TAVR patients (mean age: 84.3 ± 6.3 years, 62.1% female) were included. The mean Society of Thoracic Surgeons score was 7.3%, and 85% of patients received a balloon expandable transcatheter heart valve. Thirty-five patients (28.2%) experienced a CD, and one-third of those required pacemaker implantation. The significant preprocedural and procedural factors identified from univariate analysis included intraventricular conduction delay, mitral annular calcification, MS length ≤ 6.43 mm, self-expanding device, small left ventricular cavity, and ID ≥ 6 mm. Multivariate analysis revealed MS length ≤ 6.43 mm (adjusted odds ratio [aOR] 9.54; 95% CI 2.56–35.47; p = 0.001) and ∆MSID < 0 mm (adjusted odds ratio [aOR] 10.77; 95% CI 2.86–40.62; p = < 0.001) to be independent predictors of CD. The optimal ∆MSID cutoff value for predicting conduction disturbances was less than 0 mm (area under the receiver operating characteristic curve [AuROC]: 0.896).ConclusionThis study identified MS length ≤ 6.43 mm and ∆MSID < 0 mm as independent predictors of CDs. ∆MSID < 0 was the strongest and only modifiable predictor. Importantly, we expanded the CD criteria to cover all spectrum of TAVR-related conduction injury to lower the threshold of this sole modifiable risk. The optimal ∆MSID cutoff value was < 0 mm.Trial registration: TCTR, TCTR20210818002. Registered 17 August 2021—Retrospectively registered, http://www.thaiclinicaltrials.org/show/TCTR 20210818002.

Severity of stenosis in symptomatic patients undergoing carotid interventions might influence perioperative neurologic events

ObjectiveThe carotid artery plaque burden, indirectly measured by the degree of stenosis, quantifies a patient's future embolic risk. In natural history studies, patients with moderate degrees of stenosis have had a lower stroke risk than those with severe stenosis. However, patients with symptomatic carotid stenosis who have experienced transient ischemic attack (TIA) or stroke were found to have both moderate and severe degrees of stenosis. We examined the association of carotid artery stenosis severity with the outcomes for symptomatic patients who had undergone carotid intervention, including carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcervical carotid artery revascularization (TCAR). MethodsThe Society for Vascular Surgery Vascular Quality Initiative database was queried for all patients who had undergone TFCAS, CEA, or TCAR between 2003 and 2020. The patients were stratified into two groups according to stenosis severity—nonsevere (0%-69%) and severe (≥70%). The primary end point was periprocedural neurologic events (stroke and TIA). The secondary end points were periprocedural death, myocardial infarction (MI), and the composite outcomes of stroke/death and stroke/death/MI in accordance with the reporting standards for carotid intervention. ResultsOf the 29,614 included symptomatic patients, 5296 (17.9%) had undergone TCAR, 7844 (26.5%) TFCAS, and 16,474 (55.6%) CEA for symptomatic carotid artery stenosis. In the CEA cohort, the neurologic event rate was significantly lower for the patients with severe stenosis than for those with nonsevere stenosis (2.6% vs 3.2%; P = .024). In the TCAR cohort, the periprocedural neurologic even rate was lower for those with severe stenosis than for those with nonsevere stenosis (3% vs 4.3%; P = .033). No similar difference was noted for the TFCAS cohort, with a periprocedural neurologic event rate of 3.8% in the severe group vs 3.5% in the nonsevere group (P = .518). On multivariable analysis, severe stenosis was associated with significantly decreased odds of postprocedural neurologic events after CEA (odds ratio, 0.75; 95% confidence interval, 0.6-0.92; P = .007) and TCAR (odds ratio, 0.83; 95% confidence interval, 0.69-0.99; P = .039) but not after TFCAS. ConclusionsSevere carotid stenosis, in contrast to more moderate stenosis degrees, was associated with decreased rates of periprocedural stroke and TIA in symptomatic patients undergoing TCAR and CEA but not TFCAS. The finding of increased rates of periprocedural neurologic events in symptomatic patients with lesser degrees of stenosis undergoing TCAR and CEA warrants further evaluation with a particular focus on plaque morphology and brain physiology and their inherent risks with carotid revascularization procedures.

Long-term Outcomes of Catheter Ablation for Ventricular Arrhythmias in Post-Myocarditis Patients: Insights from a Meta-Analysis of Current Data.

BackgroundIn the past decade, catheter ablation (CA) has become a rapidly expanding treatment option for ventricular tachycardia (VT); however it is not commonly utilised for patients with post-myocarditis VT. We aimed to systematically review up-to-date evidence regarding feasibility, effectiveness, and safety of CA, with a specific focus on long-term relapse rate and procedural complications.MethodsA structured electronic database search (PubMed, Embase, Cochrane) of the scientific literature was performed according to PRISMA guidelines for studies describing outcomes at up to 7.3 years after CA. The primary outcome measured was VT recurrence post-ablation. Procedural success was defined as freedom of ventricular arrhythmias (at the end of follow-up after an ablation procedure). The secondary outcome was significant procedural complications which included procedural death, stroke, cardiac tamponade, acute myocardial infarction, major vascular complications, and major bleeding, assessed on a study-by-study basis.ResultsA total of 186 patients were included in analysis with most patients (88%) being male. Over the follow-up period, there was a 18% relapse rate (n = 34) (confidence interval (CI); 0.12–0.24, I2≈0, p = 0.77) with the majority of patients remaining VT free for the duration of follow-up. The overall procedural complication rate was 3.0% (n = 7) (CI; 0.01–0.07, I2≈0, p = 0.44), and of note, there were no peri-procedural deaths or heart transplant surgeries reported. However, a single study reported a mortality of 10% (n = 2) during the follow-up period.ConclusionsCA is an effective and durable long-term therapeutic strategy for post-myocarditis VT patients with limited relapse rate and very low complication rates based on these non-randomised data. Larger randomised-controlled trials with standardised treatment and long follow-up are required to compare CA versus conventional treatment in the post-acute myocardial phase.Supplementary InformationThe online version contains supplementary material available at 10.1007/s42399-022-01137-w.

Refined balloon pulmonary angioplasty for inoperable chronic thromboembolic pulmonary hypertension: a prospective multicenter registry

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): the National Key Research and Development Program of China Background Chronic thromboembolic pulmonary hypertension (CTEPH) is a life-threatening disease with a poor prognosis if left untreated. Pulmonary endarterectomy is the standard treatment for CTEPH, but around 40% of CTEPH patients are non-eligible for surgery. Purpose To investigate the efficacy and safety of refined balloon pulmonary angioplasty (BPA) for inoperable CTEPH in a prospective multicenter registry from China. Methods We conducted a prospective multicenter cohort study using the data from National Rare Disease Registry System of China. Total 140 consecutive patients with inoperable CTEPH who completed BPA between Jan 2016 and Dec 2020 were enrolled. The key efficacy outcomes were changes from baseline to re-evaluation in mean pulmonary arterial pressure, pulmonary vascular resistance, and six-minute walking distance. The safety outcomes were procedure-related complications. The survival outcome was all-cause mortality. Results Among the 140 patients who completed BPA, the mean age at diagnosis was 58 ± 14 years and 60.0% were female. At re-evaluation, the least-squares mean change from baseline was -18.3 mm Hg (95% confidence interval [CI], -19.9 to -16.6, P &amp;lt; 0.001) in mean pulmonary arterial pressure, -5.3 Wood U (95% CI, -5.9 to -4.6, P &amp;lt; 0.001) in pulmonary vascular resistance, and 87 meters (95% CI, 74 to 101, P &amp;lt; 0.001) in six-minute walking distance. BPA procedure-related complications occurred in 109 of 650 BPA sessions (16.8%), but severe complications requiring noninvasive positive pressure ventilation only occurred in 4 (0.6%) BPA sessions. During a mean follow-up time of 32 ± 14 months, 4 patients died, including 2 peri-procedural deaths, contributing to the survival rates of 97.8% (95% CI, 93.4 to 99.3) at 1 year and 96.9% (95% CI, 91.9 to 98.8) at 3 and 5 years. Conclusion Refined BPA appears to be an effective therapeutic option for inoperable CTEPH patients with acceptable safety profiles. Abstract Figure. Images of BPA Efficacy in a Patient Abstract Figure. Efficacy outcomes of BPA

Trends in Transfemoral Aortic Valve Implantation Related Thrombocytopenia.

Background: TAVI related thrombocytopenia (TAVI-rTP) is still very common. The aim of this study was to compare the incidence, characteristics and impact of reduced platelet counts (RPC) after TAVI between an earlier and contemporary period. Methods: the patients enrolled were those experiencing severe symptomatic aortic stenosis who underwent TAVI between January 2010 and December 2019. The exclusion criteria were no available blood tests and periprocedural death. Results: 334 patients (mean age 81.9 ± 6.7 years) were enrolled. For the earlier period, the mean RPC was 33 ± 15%, and in the contemporary period (2016–2019) it was 26 ± 14%. In the early group, we found that 62% of the patients had decreased platelet counts of more or equal to 30% in comparison to 33% in the contemporary period. The time of the procedure and the amount of the contrast that had been used in the later period were associated with significant RPCs (p value = 0.002 and 0.028, respectively). An RPC of 30% or more was associated with the increased risks of life-threatening bleeding, vascular complications and death within 30 days. Conclusion: contemporary TAVI-rTP continued to be a common phenomenon in our cohort. However, severe thrombocytopenia was significantly less frequent. An RPC of 30% or more is associated with a poor 30-day outcome.

Sex-related differences and rotational atherectomy: Analysis of 5 177 percutaneous coronary interventions based on a large national registry from 2014 to 2020

Patients undergoing percutaneous coronary interventions (PCI) with rotational atherectomy (RA) have massively calcified coronary arteries and their prognosis differs between sexes. The aim of the study was to evaluate the trends in the percentage of sexes in the subsequent years, to compare demographic characteristics between men and women, and to identify factors associated with the risk of periprocedural complications and death. We analyzed data on 751 113 patients treated with PCI between 2014 and 2020 from the Polish National Registry of Percutaneous Coronary Interventions (ORPKI). We extracted data on 5 177 (0.7%) patients treated with RA of whom 3 552 (68.6%) were men. To determine risk factors of periprocedural complications and death, a multivariable analysis was performed. The proportion of PCIs involving RA increased between 2014 and 2020 (P <0.001). Almost twice as many RA procedures were performed on men (68.55%), and that proportion did not change in the following years. The female patients were older (75.2 [8.3] vs. 70.5 [9.2] years; P <0.001). When considering periprocedural complications, their overall rate (3.45% vs. 2.31%; P = 0.01) and death rate (0.68% vs. 0.17%; P = 0.006) were greater among women. Also, via multivariable analysis, female sex was found to be a risk factor for greater periprocedural mortality (P = 0.02) and overall complication rate (P = 0.007). The majority of patients treated with RA are men and sex-related distribution was stable during the analyzed period. Female sex is a risk factor for greater periprocedural complications and mortality in patients treated with RA.

Computed Tomography Texture Analysis of Carotid Plaque as Predictor of Unfavorable Outcome after Carotid Artery Stenting: A Preliminary Study

Novel biomarkers are advocated to manage carotid plaques. Therefore, we aimed to test the association between textural features of carotid plaque at computed tomography angiography (CTA) and unfavorable outcome after carotid artery stenting (CAS). Between January 2010 and January 2021, were selected 172 patients (median age, 77 years; 112/172, 65% men) who underwent CAS with CTA of the supra-aortic vessels performed within prior 6 months. Standard descriptors of the density histogram were derived by open-source software automated analysis obtained by CTA plaque segmentation. Multiple logistic regression analysis, receiver operating characteristic (ROC) curve analysis and the area under the ROC (AUC) were used to identify potential prognostic variables and to assess the model performance for predicting unfavorable outcome (periprocedural death or myocardial infarction and any ipsilateral acute neurological event). Unfavorable outcome occurred in 17/172 (10%) patients (median age, 79 years; 12/17, 70% men). Kurtosis was an independent predictor of unfavorable outcome (odds ratio, 0.79; confidence interval, 0.65–0.97; p = 0.029). The predictive model for unfavorable outcome including CTA textural features outperformed the model without textural features (AUC 0.789 vs. 0.695, p = 0.004). In patients with stenotic carotid plaque, kurtosis derived by CTA density histogram analysis is an independent predictor of unfavorable outcome after CAS.

Complications of balloon pulmonary angioplasty for chronic thromboembolic pulmonary disease according to the classification proposed by the 6th world symposium on pulmonary hypertension

Abstract Introduction Balloon pulmonary angioplasty (BPA) is a complex procedure and not risk free. In an attempt to standardize reports of BPA complications in the several centers, a classification of complications was proposed by the task force on chronic thromboembolic hypertension (CTEPH) in the 6th World Symposium on Pulmonary Hypertension (WSPH). Purpose To determine the prevalence of BPA complications according to the classification of 6th WSPH and to identify its predictors. Methods Detailed procedural and technical aspects were collected for consecutive patients (pts) with inoperable, residual/recurrent chronic thromboembolic disease, undergoing BPA at a single institution from December/2017 to December/2020. Per procedure logistic regression analysis was used to evaluate the predictive variables for complications. Results A total of 76 BPA sessions in 15 pts were performed (mean age 63.2±14.0 years; 60.0% women; 86.7% CTEPH). Mean pulmonary artery pressure and pulmonary vascular resistance before the first BPA session were 33.1±13.3 mmHg and 4.8±3.2 woods unit, respectively (73.3% of pts under vasodilator therapy). Femoral access was used for all pts. Mean vessels treated per procedure were 4.3±1.9 (324 vessels in total). Webs, subtotal occlusions, ring-like stenosis and total occlusions were noted in 215 (66.4%), 58 (17.9%), 31 (9.6%) and 20 (6.2%) treated vessels, respectively. We performed 21 pressure-wire-guided sessions (27.6%). Intravascular imaging was used in 6 procedures (7.9%). Average time of fluoroscopy was 60.3±14.0 minutes and volume of contrast 273.0±73.0 mL per session. Procedure-related adverse events occurred in 25.0% of the interventions (27.6% in the first two years vs 16.7% in the last two). Pulmonary artery vascular injuries were noted in 6 BPA vessels (7.9% per procedure and 1.9% per treated vessel): haemoptysis in all, but perforation was only detected angiographically in 3 of them (balloon inflation was performed for 2 distal perforations, and 1 perforation sealed without any intervention). Vascular dissection in distal lesions occurred in 4 cases (5.3%) with no need of transcatheter or surgical procedures. We had 3 lung injuries, all grade 2. None of the pts required oral intubation or mechanical ventilation. Extra-pulmonary complications were illustrated in table. Importantly, there was no peri-procedural death. The occurrence of vascular or lung injuries was 0% in pressure-wire-guided BPA versus 14.5% in non-guided (p=0.098). Multivariate analysis revealed that age (OR 1.05; CI 1.01–1.10; p=0.030) was the only independent predictor of complications. Conclusions In our experience, BPA can be safely performed in inoperable, residual or recurrent CTEPH or CTED pts, with 25% minor procedural-related complications but no major adverse event. Age was the strongest factor related to the occurrence of complications. Funding Acknowledgement Type of funding sources: None.

Long-term outcomes of catheter ablation for ventricular arrhythmias in post- myocarditis patients; Insights from a meta-analysis of current datv

Abstract Background In the past decade, catheter ablation (CA) has become a rapidly expanding treatment option for ventricular tachycardia (VT), however it is not commonly utilized for patients with post-myocarditis VT. We aimed to systematically review up-to-date evidence regarding feasibility, effectiveness, and safety of CA, with a specific focus on long-term relapse rate and procedural complications. Methods A structured electronic database search (PubMed, Embase, Cochrane) of the scientific literature was performed for studies describing outcomes at up to 7.3 years after CA. The primary outcome measured was VT recurrence post-ablation. Procedural success was defined as freedom of ventricular arrhythmias (at the end of follow-up after an ablation procedure). The secondary outcome was significant procedural complications which included procedural death, stroke, cardiac tamponade, acute myocardial infarction, major vascular complications, and major bleeding, assessed on a study-by-study basis. Results A total of 186 patients were included in analysis with most patients (88%) being male. Over the follow up period there was a 18% relapse rate (n=34) (Confidence Interval (CI); 0.12–0.24, I2≈0, p=0.77) with the majority of patients remaining VT free for the duration of follow up. Only one study recorded the percentage of re-do procedures. The overall procedural complication rate was 3.0% (n=7, (CI; 0.01–0.07, I2≈0, p=0.44) and of note, there were no peri-procedural deaths or heart transplant surgeries reported. However, a single study reported a mortality of 10% (n=2) during the follow up period. Conclusions CA is an effective and durable long-term therapeutic strategy for post myocarditis VT patients with limited relapse rate and very low complication rates based on these non-randomised data. Larger randomised-controlled trials with standardised treatment and long follow-up are required to compare CA versus conventional treatment in the post-acute myocardial phase. Funding Acknowledgement Type of funding sources: None. Relapse rate during follow-upProcedural complication rate

Percutaneous transluminal pulmonary angioplasty for hypertensive pulmonary Takayasu's arteritis

Abstract Background Percutaneous transluminal pulmonary angioplasty (PTPA) is a treatment modality for chronic thromboembolic pulmonary hypertension, but whether it can be applied to patients with hypertensive pulmonary Takayasu's arteritis (PTA), another chronic obstructive pulmonary vascular disease, remains unclear. Purpose To investigate the potential efficacy and safety of PTPA for hypertensive PTA. Methods All consecutive patients with hypertensive PTA who completed PTPA in our center between January 1, 2016 and December 31, 2019 were prospectively enrolled. Hemodynamics, exercise capacity and oxygen saturation were measured at baseline and at least 3 months after the last PTPA session. PTPA procedure related complications, restenosis and all-cause deaths during follow-up were recorded. Results A total of 50 patients were enrolled, with the median age of 41 (IQR, 30–49) years and female predominance (82.0%). After PTPA, significant improvements in hemodynamics including mean pulmonary artery pressure (from median 48 [39–60] to 37 [31–42] mm Hg, p&amp;lt;0.001) and pulmonary vascular resistance (from 9.6 [7.0–11.8] to 4.8 [3.6–6.4] Wood U, p&amp;lt;0.001) were achieved. Furthermore, PTPA also significantly improved the WHO functional class (p&amp;lt;0.001), six-minute walking distance (from 412 [313–470] to 492 [430–539] meters, p&amp;lt;0.001) and arterial oxygen saturation (from 91.3 [86.9–94.1] to 93.9 [91.8–95.3] %, p&amp;lt;0.001). No peri-procedural death occurred. The most common complication was pulmonary artery injury (27/150 PTPA sessions, 18.0%), which was always asymptomatic and without further clinical sequelae. Pulmonary angiography during follow-up revealed complete self-healing in 26 out of 27 (96.3%) vessels. Restenosis occurred in 5 out of 360 treated vessels (1.4%). Three patients died during follow-up, and the 1-year, 2-year and 3-year survival rates were 98.0%, 95.7% and 92.8%, respectively. Conclusion PTPA appears to be a promising therapeutic option for patients with hypertensive PTA. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): the National Key Research and Development Program of China Efficacy of PTPA

A Study of Major and Minor Complications of 1500 Transvenous Lead Extraction Procedures Performed with Optimal Safety at Two High-Volume Referral Centers.

Background: Transvenous lead extraction (TLE) is the preferred management strategy for complications related to cardiac implantable electronic devices. TLE sometimes can cause serious complications. Methods: Outcomes of TLE procedures using non-powered mechanical sheaths were analyzed in 1500 patients (mean age 68.11 years; 39.86% females) admitted to two high-volume centers. Results: Complete procedural success was achieved in 96.13% of patients; clinical success in 98.93%, no periprocedural death occurred. Mean lead dwell time in the study population was 112.1 months. Minor complications developed in 115 (7.65%), major complications in 33 (2.20%) patients. The most frequent minor complications were tricuspid valve damage (TVD) (3.20%) and pericardial effusion that did not necessitate immediate intervention (1.33%). The most common major complication was cardiac laceration/vascular tear (1.40%) followed by an increase in TVD by two or three grades to grade 4 (0.80%). Conclusions: Despite the long implant duration (112.1 months) satisfying results without procedure-related death can be obtained using mechanical tools. Lead remnants or severe tricuspid regurgitation was the principal cause of lack of clinical and procedural success. Worsening TR(Tricuspid regurgitation) (due to its long-term consequences), but not cardiac/vascular wall damage; is still the biggest TLE-related problem; when non-powered mechanical sheaths are used as first-line tools.

In-hospital and one-year outcomes are similar for women and men following transcarotid artery revascularization in symptomatic and asymptomatic patients

ObjectiveIn randomized controlled trials and retrospective series, women have higher rates of periprocedural stroke and death following carotid endarterectomy and transfemoral carotid artery stenting compared with men. We sought to compare outcomes by sex following transcarotid artery revascularization (TCAR) among patients in the Vascular Quality Initiative (VQI). MethodsWe reviewed all patients in the VQI who underwent TCAR from 2017 to 2020. We stratified the analysis by symptom status. The primary outcome was in-hospital stroke/death, and secondary outcomes were in-hospital stroke and death and 1-year stroke/death, stroke, and death. We used multivariable logistic and Cox regression models to assess the association of sex with in-hospital and 1-year outcomes after adjusting for preoperative and intraoperative characteristics. ResultsWe identified 15,851 patients who underwent TCAR, of whom 7391 (47%) were symptomatic (2708 or 37% female) and 8460 (53%) were asymptomatic (3097 or 37% female). Women were less frequently considered anatomic high risk than men in both groups (symptomatic: 43% vs 46%; P = .004; asymptomatic: 44% vs 48%; P = .004). Among symptomatic patients, women more often had severe ≥70% stenosis (89% vs 87%; P = .02). There were no differences in in-hospital death, stroke, or stroke/death for women vs men following TCAR among symptomatic or asymptomatic patients (all P > .05). After adjusting for baseline differences between groups, female sex was not associated with in-hospital stroke/death in either symptomatic (odds ratio, 1.05; 95% confidence interval, 0.72-1.56) or asymptomatic (odds ratio, 0.93; 95% confidence interval, 0.53-1.63) patients undergoing TCAR. There were also no differences in 1-year stroke, death, or stroke/death risk for women compared with men with and without symptoms on unadjusted or adjusted analyses (P > .05). ConclusionsWe found no sex differences in in-hospital or 1-year stroke/death following TCAR, regardless of symptom status. TCAR appears to be as safe of a surgical procedure for women as for men in patients with both symptomatic and asymptomatic carotid artery disease.

The Incidence of Endoscopic Retrograde Cholangiopancreatography-Related Complications in Patients With Liver Transplant: A Meta-Analysis and Systematic Review.

BackgroundExisting literature on post-endoscopic retrograde cholangiopancreatography (ERCP) complications in patients with liver transplant remains scarce and largely inconsistent. We therefore aimed to systematically review and analyze the literature on complication rates associated with ERCP in patients with liver transplant.MethodsWe performed a comprehensive literature search in PubMed, PubMed Central, Embase, and ScienceDirect databases from inception through March 2020 to identify all the studies that evaluated post-ERCP complications in patients with liver transplant. Effect estimates from the individual studies were extracted and combined using the random effect, generic inverse variance method of DerSimonian and Laird, and a pooled odds ratio (OR) and event rates were calculated. Forest plots were generated, and publication bias was assessed for using conventional techniques.ResultsFourteen studies with a total of 1,787 patients were analyzed. In total, 3,192 ERCPs were performed on these patients. The pooled all-complication rate was 5.2% (95% confidence interval (CI): 0.035 - 0.075). Procedural complications analyzed included post-ERCP pancreatitis 3.4% (95% CI: 0.025 - 0.047), bleeding 1.1% (95% CI: 0.006 - 0.020), infections 0.2% (95% CI: 0.025 - 0.047), and cholangitis 0.8% (95% CI: 0.004 - 0.020). No cases of periprocedural death were reported. The pooled OR for post-ERCP pancreatitis in patients with liver transplant compared to patients without liver transplant was 1.289 (95% CI: 0.455 - 3.653, P = 0.633, I2 = 72.88%).ConclusionPost-ERCP complication rates in liver transplant patients are comparable to the general population and hence, peri-procedural evaluation and management may follow the current standards of care in this patient population.

The long-term efficacy and safety of combining ablation and left atrial appendage closure: A systematic review and meta-analysis.

Combined ablation and left atrial appendage closure (LAAC) is an alternative for atrial fibrillation patients with a high risk of stroke. However, the long-term outcomes of this combined procedure remain elusive. PubMed, Embase, Cochrane Library, and Web of Science were systematically searched from the establishment of databases to 1 January 2021. Studies on the long-term (defined as a mean follow-up of approximately 12 months or longer) efficacy and safety outcomes of combined ablation and LAAC were included. A total of 16 studies comprising 1428 patients were enrolled. The pooled long-term freedom rate from atrial arrhythmia was 0.66 (95% confidence interval [CI]: 0.59-0.71), long-term successful rate sealing of LAAC was 1.00 (95% CI: 1.00-1.00), and ischemic stroke/transient ischemic attack/systemic embolism during follow-up was 0.01 (95% CI: 0.00-0.02). Meanwhile, of the periprocedural adverse events, phrenic nerve palsy, intracoronary air embolus, device embolization, and periprocedural death had a rate of 0.00 (95% CI: 0.00-0.00), procedure-related bleeding events of 0.03 (95% CI: 0.02-0.04), and pericardial effusion requiring or not requiring intervention of 0.00 (95% CI: 0.00-0.01). Moreover, for the long-term adverse events, device dislocation, intracranial bleeding, pericardial effusion requiring or not requiring intervention, and all-cause mortality had a rate of 0.00 (95% CI: 0.00-0.00), device embolization of 0.01 (95% CI: 0.00-0.01), and other bleeding events of 0.01 (95% CI: 0.00-0.03). This meta-analysis suggests that the combined atrial ablation and LAAC is an effective and safe strategy with long-term benefits.

Access options for transcatheter mitral valve implantation in patients with prior surgical bioprosthesis.

Transcatheter mitral valve-in-valve (TMVIV) procedure, either transapical (TA) or trans-septal (TS) has become a valuable alternative to conventional redo surgery in case of failing mitral bioprosthesis with good clinical outcomes. Here we present our fourteen-year institutional experience. All consecutive patients treated with TMVIV with either TA or TS access at our centre between July 2007 and July 2020 were included. Periprocedural and 30-day follow-up (FU) results are reported and TA and TS data are compared. Eighty-two patients were included, of those 60 (73.2%) were TA while 22 (26.8%) were TS. Men represented 51.2% of the population with a mean age of 77.3±9.0 years. STS score and EuroSCORE II were 11.4%±6.2% and 11.5%±6.5% respectively. Baseline characteristics of TA and TS groups were comparable. TMVIV was performed at a median time of 9.3 years [interquartile range (IQR), 7.9-12.0 days] from the initial mitral valve surgery. Balloon expandable transcatheter heart valve (THV) prostheses (Edwards LifeSciences Corp., Irvine, CA, USA) were used exclusively. Technical success was 97.6% (96.7% and 100.0% for TA and TS respectively) with two (2.4%) periprocedural death, both in the TA group (P=0.533). We observed four (4.9%) left ventricular outflow tract (LVOT) obstructions with one being hemodynamically significant. Six (7.3%) major bleeding occurred in the TA group, not significantly different from TS group (P=0.279). The median length of stay was 6 days (IQR, 4-12 days, 1.5 vs. 7.0 days for TS and TA groups respectively, P=0.001). The overall 30-day mortality rate was 3.7%. We also observed three (3.7%) structural valve deteriorations and in one (1.2%) case the patient required redo mitral surgery at two months. Eighty-seven-point-eight percent of patients were I-II New York Heart Association (NYHA) class. At 30-day FU mean transmitral valve gradient was 7.3±2.7 mmHg and one patient (1.2%) had mitral regurgitation greater than mild. TA and TS groups were comparable. Our 14-year single-center experience with TMVIV confirms procedural safety and is an effective alternative to redo surgery with comparable results with both TA and TS. With device, technical improvements and increasing operators' experience, TS is the preferred option for TMVIV. However, in some highly selected patient, TA may still play an important role.

Transcatheter mitral valve replacement for degenerated mitral bioprostheses: a systematic review.

Treatment of degenerated mitral bioprostheses with transcatheter mitral valve-in-valve (MVIV) implantation is increasingly used. The goal of this review was to evaluate the one-year outcomes of this therapy using the most recent evidence. A MEDLINE, Cochrane database and SCOPUS search was performed of published observational studies involving patients undergoing transcatheter MVIV for degenerated bioprosthesis to determine procedural success, thirty-day and one-year survival. A total of 2,684 patients undergoing transcatheter MVIV were identified from five studies with mean age of 73-75 years, 57-63% female and Society for Thoracic Surgery (STS) risk score ranging from 9-13%. Procedural technical success ranged from 94-98%, with 1-3% rates of periprocedural death, 0-2% stroke and 1-5% risk of left ventricular outflow tract (LVOT) obstruction. Thirty-day post-procedure mean mitral prosthetic gradient ranged from 6-7 mmHg and residual mitral regurgitation was mild or less in 96-100% of patients. Thirty-day survival and one-year survival ranged from 93-97% and 83-89% respectively. Transcatheter MVIV is an effective treatment for structural degeneration of biologic mitral valve replacement with low complication rates and favorable one-year outcomes. Accordingly, MVIV should be considered as a reasonable alternative to re-do surgical mitral valve replacement in high risk patients with comorbidities. Further study of long-term outcomes of this treatment is needed.