Complication Of Implantation Research Articles

Outcomes of Baerveldt Glaucoma Drainage Devices in Pediatric Eyes.

Précis:In children, Baerveldt implants showed 84% success at 1 year, but decreased to 32% at 8 years. Age, race, and glaucoma type were not risk factors for failure. Concurrent intraocular surgery was associated with complications.Purpose:Evaluate success and risk factors for failure and complications of Baerveldt glaucoma implants in children.Methods:Retrospective case series of children who underwent Baerveldt implant placement (2012-2019 by single surgeon) with ≥1 year follow-up. Ocular examination and surgical details were collected. Failure defined as intraocular pressure (IOP) <5 mm Hg or >21 mm Hg for 2 consecutive visits, need for IOP related surgery, or visually significant complication.Results:One hundred-six eyes of 76 patients underwent 110 Baerveldt placement at median 6.4 years. Baerveldt placement was combined with additional procedures in 49% with vitrectomy most common (30%). Success of first Baerveldt (per patient) was 64% at final follow-up (median 4.7 y). One-, 5-, and 8-year survival rates were 84%, 60%, and 32%, respectively. There was no difference (P=0.97) in survival between first Baerveldt and all Baerveldt surgeries. Failure of first Baerveldt was not associated with sex, age, ethnicity, prior IOP-lowering surgery, concurrent intraocular surgery, or glaucoma type. Complications occurred in 14% and were associated with concurrent surgery. Twenty-six percent required additional IOP-lowering surgery. At final follow-up, IOP and glaucoma medications were significantly decreased (P<0.0001). Eyes underwent an average of 3.8±2.3 ocular surgeries and 3.0±2.0 glaucoma surgeries.Conclusions:Baerveldt implants showed good success initially, but survival rates declined over time. No risk factors for failure of first implanted Baerveldt were identified. Concurrent surgery was associated with complications. Majority of eyes required multiple surgeries to achieve IOP control and preserve vision.

656 Cough, a rare and not well recognized symptom of lead perforation

Abstract Aims Along with relevant progress in technology, pacemaker implantation is continuously improving its safety and efficacy in treating patients with bradyarrhythmias. Despite this, this procedure has several complications, including haematoma, pneumothorax, lead dislodgement, infection, lead perforation, and tamponade. Methods and results A 64-year-old woman underwent loop recorder implantation, after recurrent loss of consciousness, in order to assess arrhythmic causes of syncope. Two weeks later, an episode of paroxysmal complete AV block, conditioning a pause of 3 s, was recorded. Thus, the patient was scheduled for urgent dual-chamber pacemaker implantation. No complication apparently occurred during the procedure. An active fixation ventricular lead was positioned in right ventricular septal apex while passive fixation atrium lead in the right appendage. Soon after implantation the patient started to suffer by non-productive cough, clearly related to ventricular stimulation, either in DDD or in VVI pacing modality. During spontaneous ventricular activation (RBBB) no symptoms occurred. Transthoracic echocardiography, performed the day after implantation, revealed a small pericardial effusion (diastolic diameter &amp;lt; 10 mm) along the apical segments, near the tip of the right ventricular lead. Suspicion of right ventricular lead perforation arised. The patient underwent urgent contrast chest CT confirming pericardial effusion, and showing an intramyocardium placement of the right ventricular apical lead. No active bleeding in pericardium was observed. Due to persistence of symptoms, we decided to perform right ventricular lead repositioning in right middle septum, with pericardiocentesis back-up promptly available. Post-procedure, palpitation, and cough abruptly disappeared. After 3 months follow-up, no significant symptoms were reported and pericardial effusion gradually disappeared. Conclusions We describe a singular case of cough, as atypical symptom immediately after pacemaker implantation. Pericardial effusion and contrast-CT showing intra-myocardial position of the tip guided our suspicion to a possible right ventricular lead microperforation. Although right ventricular lead parameters were completely normal this findings didn’t exclude RV perforation. The lead perforation is known as a rare complication of device implantation. Typical symptoms of RV lead perforation are chest pain and hypotension. The patient described in our case showed a haemodynamically stable pericardial effusion accompanied by non-productive cough, clearly time-related to RV stimulation. In literature, there is only another similar case report. The cough is a rare and not well recognized symptom of lead perforation. Early diagnosis of RV perforation allows to perform urgently and safely (pericardiocentesis back-up) lead replacement/repositioning. Echocardiography and contrast-CT could be useful in order to assess a possible pericardial effusion or intramyocardial/pericardial position of RV lead tip.

OZONE THERAPY IN THE COMPLEX TREATMENT OF DENTAL IMPLANTATION COMPLICATIONS

Abstract: Dental implantation is an effective method of treating secondary adentia due to the complete restoration of the functional activity of the maxillary system and a pronounced aesthetic effect by replacing the removed tooth with an artificial one using a special design fixed inside the alveolar process. Currently, the use of dental implants for independent or additional supports of fixed prostheses has greatly expanded the capabilities of orthopedic dentists. But the problem of instability of the processes of osseointegration of implants and the long-term preservation of the connection of the implant and the surrounding bone tissue, especially in patients with various occlusive disorders, remains one of the most important and needs new solutions. The analysis of studies shows that excessive and uneven chewing load causes a weakening or violation of the processes of stabilization of the state of the bone connection zone with the implant, which provokes resorption of the alveolar process. Functional overload and insufficiency of the dentition are caused by occlusive disorders due to the uneven distribution of masticatory pressure on the tissues surrounding the implants and supporting teeth. These factors have an adverse effect on the state of regional blood circulation. According to some authors, with dental implantation, complications are observed in 7-19% of cases, mainly of inflammatory genesis. In connection with the above data, it is very important to optimize the processes of osseointegration of dental implants, as well as, in particular, to prevent inflammatory complications. The use of ozone therapy in the complex treatment of complications of dental implantation allows us to achieve these goals, and the use of ozone therapy for the prevention of complications of dental implantation allows us to achieve a reduction in the occurrence of complications.

CT Image Feature Diagnosis on the Basis of Deep Learning Algorithm for Preoperative Patients and Complications of Transcatheter Aortic Valve Implantation.

This work was aimed to explore the role of CT angiography information provided by deep learning algorithm in the diagnosis and complications of the disease focusing on congenital aortic valve disease and severe aortic valve stenosis. 120 patients who underwent ultrasound cardiography for aortic stenosis and underwent transcatheter aortic valve implantation (TAVI) in hospital were selected as the research objects. Patients received CT examination of deep learning algorithm within one week. The measurement methods were long and short diameter method, area method, and perimeter method. The deep learning algorithm was used to measure the long and short diameter, area, and perimeter of the target area before CT image processing. The results showed that the average diameter of long and short diameter measurement was 95% CI (0.84, 0.92), the average diameter of perimeter measurement was 95% CI (0.68, 0.87), and the average diameter of area measurement was 95% CI (0.72, 0.91). Among the 52 patients, 35 cases were hypertension (67%), 13 cases were diabetes (25%), 6 cases were chronic renal insufficiency (Cr > 2 mg/dL) (11%) (2 cases were treated with hemodialysis, 3.8%), 11 patients had chronic pulmonary disease (21%), 9 patients had cerebrovascular disease (17.3%) and atrial flutter and atrial fibrillation. Deep learning can achieve excellent results in CT image processing, and it was of great significance for the diagnosis of TAVI patients, improving the success rate of treatment and the prognosis of patients.

P095 ARE POLYPROPYLENE MESH IMPLANTS ASSOCIATED WITH SYSTEMIC AUTOIMMUNE/INFLAMMATORY SYNDROMES?

Abstract Aim Worldwide there is a lot of commotion about the effects and complications of mesh implants. The surgical implantation of polypropylene (PP) meshes has been linked to the occurrence of systemic autoimmune disorders (SAIS). We performed a systematic review to determine whether PP implants for inguinal, ventral hernia or pelvic floor surgery are associated with the development of SAIS. Material and Methods We searched Embase, Medline, Web of Science, Scopus, Cochrane library, clinicaltrialsregister.eu, clinicaltrails.gov and WHO-ICTR platform. Forward and backward reference searching was performed to avoid missing relevant papers. All types of studies, except case studies, reporting SAIS in patients having a PP implant for either pelvic floor surgery, ventral or inguinal hernia repair were included. Animal studies were excluded. We intended to perform a meta-analysis. The quality of evidence was assessed with the Newcastle-Ottawa Scale. This study was registered at Prospero (CRD42020220705). Results Of 1938 records identified, 3 were eligible. Two studies involving retrospective matched cohorts focused on mesh surgery for vaginal prolapse or inguinal hernia compared to hysterectomy and colonoscopy, respectively. These reports had a low risk of bias. The third study was a case-series with a high risk of bias, with a sample of 714 patients with systemic disease, 40 of them had PP mesh implanted. A meta-analysis showed no association when comparing systemic disease between mesh and control groups. Calculated Risk Ratio was 0.9 (95%CI 0.78-1.04). Conclusions To date, there is no evidence to suggest a causal relationship between being implanted with a PP mesh and the occurrence of SAIS.

Periprocedural complications of cardiac implantable electronic device implantation in very elderly patients with cognitive impairment: A prospective study.

Very elderly people (over 80 years) with cardiac implantable electronic devices (CIEDs) indications often have a higher prevalence of aging comorbidity, among which cognitive impairment is not uncommon. This study aimed to investigate periprocedural complications of CIED implantation among very elderly patients with and without cognitive impairment. One hundred eighty patients ≥80 years of age indicated for CIED implantation were included in our study. During hospitalization, the cognitive evaluation was performed according to the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). According to the cognitive test results, patients were divided into 2 groups (90 patients with normal cognitive function and 90 patients with cognitive impairment). Meanwhile, their physical parameters and laboratory measurements were completed. The procedural data and periprocedural complications were collected from both groups. The association between cognitive impairment and periprocedural complications was analyzed using univariate and multiple logistic regression analyses. During a one-month follow-up, the most frequent periprocedural complications in very elderly patients were pocket hematoma and thrombosis events. Cognitively impaired patients had a higher incidence of complications than normal cognitive patients. Multivariate regression analysis showed that cognitive impairment was positively correlated with periprocedural complications in very elderly patients. Cognitive impairment is associated with increased periprocedural complications of CIED implantation in very elderly patients.

Abstract 9338: In-hospital Complications During 35747 Permanent Pacemaker Implantations from 2009-2018: A Statewide Australian Cohort Study

Background: Permanent pacemaker implantation (PPI) is standard of care for significant bradyarrhythmia since the early 1960’s. Understanding its utilisation and projection in our ageing populations has important implications on medical resource utilisation. This study reports the rates of PPI in the state of New South Wales (NSW), Australia from 2009-2018. Hypothesis: We hypothesized PPI in patients ≥80yrs has increased faster than in &lt;80yrs over past decade. Methods: We examined the prevalence of PPI from Jan 2009 to Dec 2018 by extracting administrative details of all permanent pacemakers implanted statewide, including patient’s characteristics and in-hospital complications using the NSW Centre-for-Health-Record-Linkage datasets. All analysis was stratified by age &lt;80yrs vs ≥80yrs old. Results: A total of 35747 admissions involved PPI (60% males) during the study period. The mean ±SD implantation rate and age was 3574±311 PPI per annum and 78±10yrs respectively. 18187 (50.9%) of PPI were in patients ≥80yrs. The mean annual rate of PPI was 593.4±57.6 per 100000 persons for ≥80yrs, compared to 24.5±2.1 per 100000 persons in &lt;80yrs (p=0.0001). The overall mean rate of increase in PPI from 2009-2018 for ≥80yrs old was 2.6±3.7% compared to 1.7±3.2% per annum in &lt;80yrs (p=0.001). The median (interquartile range [IQR]) length of stay (LOS) in patients ≥80yrs requiring emergency PPI was 8 (5-14) days, compared to 1 (1-3) days in those who had an elective PPI procedure, p&lt;0.05. For patients &lt;80yrs old, the median (IQR) LOS was 7 (4-12) days compared to 1 (1- 2) days, p&lt;0.05 respectively. Overall, complications of pacemaker implantation excluding death was 8%. Although overall in-hospital mortality was low, it was higher for patients ≥80yrs compared to the &lt;80yrs group (0.9% vs 0.6%; p&lt;0.001). Overall complication rates declined only in last two years of the study period, with no significant change for in hospital death. Conclusion: Overall PPI increased between 2009-2018, with the increase greatest in patients ≥80yrs. Overall complication rates remained elevated, with in-hospital mortality higher in the older group. Future studies should examine strategies that reduce in-hospital complications during pacemaker implantations.

Abstract 9153: Predictive and Protective Factors of Early, Late, and Very Late Stent Thrombosis in Acute Coronary Syndrome Patients Undergoing Coronary Stent Implantation: Findings from the Atlas Acs 2-timi 51 Trial

Introduction: Stent thrombosis (ST) is an uncommon but serious complication of stent implantation. The aim of this analysis was to explore predictive and protective factors of early, late, and very late ST. Methods: This was a post-hoc analysis of the ATLAS ACS 2-TIMI 51 trial, which included acute coronary syndrome patients who received stent placement. Incidence of ST was assessed by Kaplan-Meier estimates at 30 days, 31 to 360 days, 361 to 720 days, and up to 720 days, with day 1 defined as the day of stent implantation. Multivariable associations with ST were explored by fitting Cox proportional hazards models. The covariates included patient characteristics, baseline laboratory tests (i.e., cardiac biomarkers, hemoglobin, platelet count, white blood cell [WBC]), and ST treatment (i.e., drug-eluting stent [DES] vs. bare-metal stent and anticoagulant with rivaroxaban vs. placebo). Results: Among 8,741 stented patients, a total of 155 ST events (2.25%) occurred by day 720. The cumulative incidence of early, late, and very late ST was 0.80%, 0.81%, and 0.77%, respectively. After multivariable adjustment, age ≥75 years (HR=2.13 [95% CI: 1.26-3.60]), a history of prior myocardial infarction (MI) (HR=1.81 [95% CI: 1.22-2.68]), low hemoglobin (HR=2.34 [95% CI: 1.59-3.44]), high WBC (HR=1.58 [95% CI: 1.02-2.46]), DES (HR=0.56 [95% CI: 0.38-0.83]), and rivaroxaban (HR=0.63 [95% CI: 0.44-0.88]) were associated with overall ST. Low hemoglobin (HR=2.35 [95% CI: 1.34-4.12]) and high WBC (HR=2.11 [95% CI: 1.17-3.81]) were predictive of early ST. Low hemoglobin (HR=2.32 [95% CI: 1.26-4.27]), prior MI (HR=2.98 [95% CI: 1.67-5.31]), and DES (HR=0.33 [95% CI: 0.16-0.67]) were associated with late ST. Age ≥75 years was predictive of very late ST (HR=3.71 [95% CI: 1.12-12.3]). Conclusions: The study identified factors with positive and negative associations with early, late, and very late ST that may be useful in constructing risk assessment models for ST.

Abstract 14036: Post Transcatheter Aortic Valve Replacement (TAVR) Electrophysiologic (EP) Study Trends and Its Implication on Permanent Pacemaker (PPM) Implantation Rate: Insights From National Inpatient Sample Database

Introduction: High-risk conduction (HRC) disorders are frequently encountered post transcatheter aortic valve replacement (TAVR). There is a robust expert consensus statement about the management of such patients (e.g.performance of an electrophysiology (EP) study). Yet, it is unclear what the real-world practices are and how they might be influencing outcomes. Hypothesis: Accordingly, we sought to study the trends and implications of EP study post TAVR on the PPM implantation rate. Methods: The National Inpatient Sample (2011-2018) database was queried, using ICD-9 and ICD-10 codes, for individuals who underwent a TAVR procedure. Patients with a history of PPM were excluded. Outcomes of interest were postprocedural EP study, PPM implantation, mortality, and other non-cardiac complications. Logistic and linear regression models were employed to study hospital outcomes. Results: A total of 1,95162 (median age 82 yrs, 47.9% female) underwent TAVR. HRC abnormality and CHB were seen in 19.5% and 11 % of patients, respectively. A total of 12.1% had PPM implantation post-procedure, and 0.77% had an EP study during the same hospitalization. Of all PPM implantations, 2% underwent a prior EP study. Among patients with HRC features (N=33,381), the odds of receiving a PPM were ~3 higher (OR [95% CI] =2.74 [1.92, 3.90], p&lt;0.0001) in those who underwent an EP study (vs. no EP study). Among patients with CHB (N=21,324), there was a 60% (OR [95% CI] =0.39 [0.23, 0.67], p=0.001) decrease in PPM implantation rate in those who underwent an EP study (vs. no EP study). EP study was associated with a longer length of stay (p&lt;0.001) and higher hospital charges (p=0.001) with no difference in mortality rates (p=0.16). The yearly trend of EP study and PPM implantation is shown in figure 1. Conclusions: Depending on the type of conduction disorder, EP study has a significant and variable influence on the rate of PPM implantation post TAVR. The clinical implication of such impact needs further studies.

Association Between Previous or Active Cancer and Clinical Outcomes in TAVR Patients: A Systematic Review and Meta-Analysis of 255,840 Patients

Background: It has been proposed that transcatheter aortic valve replacement (TAVR) may be an option for patients with cancer and severe aortic stenosis. We assessed the association between previous or active cancer and clinical outcomes in TAVR patients.Methods: We searched four electronic databases from inception to March 05, 2021. The primary outcome was all-cause mortality. Secondary outcomes were cardiovascular mortality, myocardial infarction, stroke, acute kidney injury, pacemaker implantation, major bleeding, and vascular complications. All meta-analyses were performed using a random-effects model. Relative risks (RRs) and adjusted hazard ratios (aHRs) with their 95% confidence interval (95% CI) were pooled.Results: Thirteen cohort studies involving 255,840 patients were included. The time period for mortality ranged from inpatient to 10 years. Patients with active cancer had a higher risk of all-cause mortality using both crude (RR, 1.46; 95% CI, 1.13–1.88) and adjusted (aHR, 1.79; 95% CI, 1.43–2.25) estimates compared to non-cancer group. In contrast, the risk of cardiovascular mortality (RR, 1.26; 95% CI, 0.58–2.73), myocardial infarction (RR, 0.94; 95% CI, 0.34–2.57), stroke (RR, 0.90; 95% CI, 0.75–1.09), pacemaker implantation (RR, 0.87; 95% CI, 0.50–1.53), acute kidney injury (RR, 0.88; 95% CI, 0.74–1.04), major bleeding (RR, 1.15; 95% CI, 0.80–1.66), and vascular complications (RR, 0.96; 95% CI, 0.79–1.18) was similar between patients with or without cancer.Conclusion: Our review shows that TAVR patients with active cancer had an increased risk of all-cause mortality. No significant association with secondary outcomes was found.

Control of a Mechanical Blood Pump based on a Trade-off between Aortic Valve Dynamics and Cardiac Outputs.

Left ventricular assist device (LVAD) is a therapeutic option for advanced heart failure (HF) patients. This mechanical device assists a failing heart to circulate blood in the human body by adjusting its pump speed according to cardiac output. However, to use an LVAD for bridge-to-recovery, other criteria (e.g., aortic valve function) should be also considered to reduce complications of the LVAD implantation. In this work, we present an optimization-based control approach to meet the circulatory demand of blood, while maintaining the aortic valve to open and close repeatedly in a cardiac cycle. To validate the performance of the control method, several case studies were investigated, which incorporate different levels of HF severity and physical activity. The results show that the optimization-based control algorithm can quantify the trade-off between the aortic valve function and the blood flow, which will meet clinicians' long quest to improve the myocardial functions for the use of an LVAD as bridge-to-recovery.Clinical Relevance-The efficacy of the control algorithm was validated with computer experiments, showing its potential as a bridge to recovery or as a long-term treatment plan for HF.

A Novel Technique for Autologous Supratip Augmentation: Septal Gap Graft.

Although it has been common to use artificial implant to augment nasal dorsum in Asian rhinoplasty, the demand for not using it is increasing due to the long-term complications of implants. However, if only the tip is raised without raising the dorsum with implant, it is difficult to avoid supratip depression, so it is difficult to obtain good cosmetic results. The authors would like to report good results, performing an augmentation rhinoplasty that raises the supratip area using the nasal septal cartilage without using an implant. Septal gap graft was used in 22 patients undergoing nasal tip surgery from January 2019 to April 2021. Septal gap graft refers to a graft that increases the height of the supratip area by using septal cartilage. Firstly, the authors perform a septal extension graft using the septal cartilage, then the authors fix the lower lateral cartilage in an ideal position, and lastly the authors heighten the nasal tip with onlay graft. The height difference between the nasal bone and the nasal tip, is solved by placing the septal cartilage. Before, during and after surgery, photometric analysis was done by taking clinical pictures. Through the septal gap graft, the supratip depression index was decreased and the nasal tip projection was increased. It was confirmed that the septal gap graft was well maintained at long-term follow-up, and the patients' postoperative satisfaction was also high. The authors presented a new technique for augmentation rhinoplasty in Asians. Septal gap graft can be used safely and effectively to raise supratip area without using implant.

Experience with various occluder types for endovascular hemodynamic isolation of the left atrium appendage in patients with non-valvular atrial fibrillation

The aimof our study was to evaluate implantation efficacy and safety across various occluder types and to identify factors determining device selection.Methods. This single-site prospective observational study included patients above the age of 40 years with non-valvular atrial fibrillation (AF) and high thromboembolic risk, undergoing endovascular isolation of the left atrium appendage (LAA) with Watchman or Amplatzer Cardiac Plug/Amulet devices. Occluders were implanted to patients without either had contraindications to anticoagulant therapy (ACT) or refused ACT. We evaluated technical aspects of device implantation, short- and long-term outcomes of the intervention over 3 years of follow-up.Results. 90 patients were enrolled in the study (62 into the Watchman arm and 28 into the Amplatzer arm). Interventions were technically successful in 89 cases. In 1 patient (1/90, 1.1%) technical success was not achieved due to device migration (Amplatzer Amulet). The incidence of early (occurring within˂ 24 hours) implantation complications was 0% in the Watchman arm, and 3.6% in the Amplatzer arm (1/28) (р=0.135) (device migration). The cumulative incidence of all in-hospital complications was 11.3% and 14.3%, respectively (р=0.734). No significant differences between arms were found in the incidence of device thrombosis within 90 days post-implantation (3.3% in the Watchman’s arm and 8.3% in the Amplatzer arm, р=0.316). During the observation period, there were no significant differences in comparison groups in the incidence of net clinical efficacy endpoint events (р=0.58). The bleeding rate was 17.7% and 14.3%, respectively, р=0.769. No factors influencing the choice of the device could be identified reliably; however, there was a trend towards Watchman preference for appendage anatomic variants such as broccoli and cactus. Amplatzer was preferred in patients with contraindications to ACT.Conclusion.Implantation of Watchman and Amplatzer Amulet occluders is equally effective and safe in preventing thromboembolism in patients with AF not receiving ACT for various reasons. The individual choice of a device may be influenced by appendage anatomy and indications to occluder implantation.

Stents in the Management of Stenotic and Occlusive Lesions in the Venous System.

Occlusive disease of the iliac veins or major intrathoracic veins have traditionally been managed by conservative management or by major vascular reconstructive procedures. Over the past 15-20 years, these lesions have become amenable to management with venous stents. Lesions in the iliac venous system are typically due to thrombus secondary to deep vein thrombosis, and lesions in the superior vena cava are due to either malignant intrathoracic lesions, indwelling central venous catheters, pacemaker leads, or enlarged nodes due to granulomatous disease. The success rate for implantation is between 92% and 95% and associated implantation complications vary between 2% and 5%. Primary patency of iliac stents is 70-90% at three years. Venous stents have higher patency in the treatment of stenotic lesions compared to totally occlusive lesions. Primary patency of stents placed in the superior vena cava is also about 70-90% and generally lower in lesions due to malignancy likely related to life expectancy. Stents in the venous system are associated with few complications at the time of insertion and have excellent long-term patency.

Aortic systolic blood pressure predicts periprocedural myocardial injury after transcatheter aortic valve implantation

Abstract Background/Introduction Periprocedural myocardial injury (PPMI) is a complication of transcatheter aortic valve implantation (TAVI) associated with worse outcome. Central (aortic) systolic blood pressure (SBP) is an independent predictor of cardiovascular events. Purpose We sought to investigate the effect of TAVI on peripheral and central hemodynamics, as well as the predictive ability of brachial and aortic SBP for PPMI. Methods We enrolled 70 patients (mean age 79.9±8.7 years, 50% males) with severe symptomatic aortic valve stenosis (AVS) undergoing TAVI. Brachial pressures were measured with an oscillometric device and central pressures were assessed by arterial tonometry at baseline and after the procedure at discharge. PPMI was identified based on Valve Academic Research Consortium (VARC-2) criteria. Biomarkers for MI (cardiac troponin and creatinine kinase MB) were analyzed and signs and symptoms according to VARC-2 criteria were collected from clinical records. Stepwise multivariable regression analysis was performed for the prediction of PPMI. Results According to VARC-2 definition, 38 (54%) patients had PPMI. In stepwise multivariable regression analysis, brachial SBP at baseline was not predictive of PPMI (p=0.07) after adjusting for age, sex and history of coronary artery disease. On the contrary, aortic SBP predicted PPMI even after adjustment for the abovementioned confounders (Odds ratio [OR]=1.032, 95% Confidence Interval [CI] 1.004–1.061, p=0.026). Interestingly, both SBP and aortic SBP were higher at discharge in patients with PPMI compared to patients without PPMI after adjustment (p=0.021 and p=0.006, respectively). On the contrary, the periprocedural changes of aortic SBP and SBP were not different between patients with PPMI and without PPMI. Conclusions Aortic SBP, as assessed by tonometry, is an independent predictor stronger than brachial SBP for PPMI in AVS patients treated with TAVI. This finding suggests the possible clinical role of aortic pressures as a risk stratification tool for PPMI prior to TAVI, as well as, warrants further investigation on their role as therapeutic targets to decrease the incidence of PPMI. Funding Acknowledgement Type of funding sources: None.

Predicting pacemaker dependency after TAVI with pre-procedural MSCT

Abstract Background and aim High degree conduction disturbances is a burdensome complication of transcatheter aortic valve implantation (TAVI). There is limited data whether such disorders are permanent or reversible. Anatomic surrogates, such as membranous septum [MS, a distance marker from aortic annulus to His-bundle surge] and calcium distribution within aortic valve have been associated with pacemaker (PM) implantation. The aim of our study was to assess predictors of long-term pacemaker dependency following TAVI. Methods Single center prospectively included patients that underwent pacemaker implantation following TAVI (March 2017 to September 2020). Patients who were lost to follow up, with bicuspid aortic valve, previously implanted PM and non-available or low quality MSCT exam were excluded. On MSCT, MS length was measured on modified coronal view, the aortic-valvular complex (AVC) was characterized by leaflet sector and calcium distribution was assessed on a J-score threshold of 850-Hounsfield units. Pacemaker dependency was assessed by reducing ventricular pacing to 30 bpm and defined by subsequent complete AV dissociation in patients in sinus rhythm or an escape rhythm &amp;lt;50 bpm in atrial fibrillation, in addition of &amp;gt;90% pacing percentage since implantation. Results From the 352 patients with inclusion criteria, 67 underwent PM implantation (19%) and 55 included in the analysis (male 33.9%, median age=85) (Figure). Median time for pacemaker implantation was 3 days [interquartile range (IQR) 3–5 days], mostly due to complete auriculo-ventricular block (76.4%, N=42). PM dependency occurred in 14 out of 55 (25.5%) patients at mean follow up of 500±363 days. Patients with PM dependency tended to have deeper implantation depth, (6.2 mm vs 5.5 mm, p=0.096) and a significantly shorter MS (5.8 mm vs 6.8 mm, P-value = 0.031) (Table). Increasing MS length was independently associated with a lower risk of PM dependency [odds ratio (OR) 0.58 per mm; 95% CI: 0.35–0.98, p=0.04] regardless prosthesis choice. MS length under 5 mm had 97.6% specificity (95% CI: 87.1–99.9) and 85.7% positive predictive value for pacemaker dependency (AUC=76.7; 95% CI 63.3–87). Conclusion Our findings highlight the importance of MSCT-derived MS length to stratify the risk of long term need for pacemaker. Patients with short MS (&amp;lt;5mm) in addition to conduction abnormality following TAVI had a high likelihood of PM dependency on the long term and should be considered for prompt PM implantation. Funding Acknowledgement Type of funding sources: None.

Outcomes of leadless pacemaker implantation in patients with mechanical heart valves

Abstract Introduction Device-related infections constitute a major complication of transvenous pacemaker implantation. Mechanical heart valves (MHV) increase the risk of infective endocarditis (IE) and pacemaker infection, worsening their outcomes.Leadless pacemakers (LP) have been associated with low infection rates and thus pose an attractive option in MHV patients requiring permanent pacing. Methods and results This is a multicenter, observational, retrospective study including all consecutive patients implanted with an LP at 5 tertiary referral centers between June 2015 and January 2020.Procedural outcomes, complications, performance during follow-up and episodes of bacteremia and IE were recorded and compared between patients with and without a MHV (MHV and non-MHV groups).Four hundred fifty-nine patients were included (74 in the MHV group, 16.1%, and 385 in the non-MHV group, 83.9%).Implantation success, procedural outcomes and acute electrical performance were comparable between groups.Vascular complications and cardiac perforation occurred in 2.7 vs. 2.3% (p=1) and 0% vs. 0.8% (p=1) in the MHV group and non-MHV group, respectively.During a median post-implant follow-up of 308 days for the MHV group and 416 days for non-MHV patients (p=0.029), one case of IE was reported in the MHV group and 2 in the non-MHV group. All three occurred in patients with abandoned transvenous leads. Conclusion LP implantation is feasible and safe in patients with MHV, with procedural outcomes and electrical performance comparable to the general LP population. Device-related infections, including IE, are rare in patients receiving an LP, including those with an MHV. LP implantation should be considered in MHV patients with an indication for pacing. Funding Acknowledgement Type of funding sources: None. Procedural outcomes and complicationsBaseline and follow-up parameters

Identifying predictive risk factors for permanent pacemaker implantation up to 30 days post-TAVI

Abstract Background Conduction system abnormalities, including AV block, are amongst the most common complications of transcatheter aortic valve implantation (TAVI). Post-TAVI high degree AV block necessitates permanent pacemaker (PPM) implantation. Purpose To assess the ability of standardly available pre-, intra- and post-TAVI factors to predict PPM implantation within 30-days post procedure. Methods Demographic and clinical (pre-, intra-, and post-procedural) data including ECG parameters were collected from all patients who underwent TAVI at our centre from August 2017 to November 2020. Patients with pre-existing PPM were excluded from the study. Predictive factors were selected through univariate analysis, and selected characteristics were incorporated into a multivariate binomial logistic regression model, in order to create a 30-day PPM risk-prediction model. The Akaike information criterion (AIC) and area under receiver operating curve (AUC/C-statistic) were used to assess discriminative performance. Results In total, data from a total of 446 patients were analysed. Of these, 40 (8.97%) received PPM implantation within 30 days of the procedure. The mean age of the patients was 81.5 (±7.3 SD) years; 99 (22.2%) had pre-existing first degree AV block, 55 (12.3%) had pre-existing left bundle branch block (LBBB) and 50 (11.2%) had pre-existing right bundle branch block (RBBB). Intra-procedurally 40 (9.0%) developed LBBB, 21 (4.7%) developed 3rd degree AV block, and 95 (21.3%) patients required temporary pacing wire (TPW) pacing. Post-procedurally, 138 (30.9%) exhibited AV block, 107 (24.0%) LBBB and 50 (11.2%) RBBB. The following factors met significance at multivariate logistic regression analysis: pre-TAVI RBBB (OR 6.62 [95% CI, 1.37–36.51]), intra-TAVI 3rd degree AV block (OR 12.80 [95% CI, 3.44–53.34]), intra-TAVI LBBB (OR 4.02 [95% CI, 1.28–12.53]), use of TPW pacing (OR 8.58 [95% CI, 3.19–25.12]) and post-TAVI LBBB (OR 7.84 [95% CI, 2.75–24.46]) (Table). Finally, variables were incorporated into a multivariate logistic regression model with the outcome variable of 30-day PPM implantation (Figure 1a). A model incorporating five factors (pre-TAVI RBBB, intra-TAVI 3rd degree AV block, intra-TAVI LBBB, use of TPW pacing and post-TAVI LBBB) demonstrated excellent discriminative ability (accuracy 0.925 and an AUC of 0.952) at predicting PPM implantation (Figure 1b). Conclusions Following variable selection, the best performing model incorporated five factors including pre-TAVI RBBB, intra-TAVI AV block (3rd degree), intra-TAVI LBBB, use of TPW pacing and post-TAVI LBBB. We aim to validate this model using an external cohort. Funding Acknowledgement Type of funding sources: None. Table 1Figure 1

Predictors of cardiac implantable electronic device infection in the United States

Abstract Background Cardiac implantable electronic devices (CIED) are important tools for managing arrhythmias, improving hemodynamics, and preventing sudden cardiac death. Device infection (DI) remains a significant complication of CIED and is associated with high morbidity, mortality, and healthcare cost. Purpose To analyze predictors of DI and its in-hospital outcomes. Methods National Inpatient Sample 2011–2018 database was analyzed for admissions for CIED implantation or DI. Baseline and hospital level characteristics were derived. The Chi-square test and student t-test were used for comparison of categorical and continuous variables respectively. Variables with p&amp;lt;0.20 from univariate analysis were included in the multivariate logistic regression to identify independent predictors of DI. Results A total of 1,604,173 admissions for CIED implantations and 71,007 (4.4%) admissions for DI were reported during 2011–2018. There was no significant change in annual admissions for DI (range 8550 to 9307, p for trend=0.98). Those with DI were more likely to be male (69.3 vs 57%, p&amp;lt;0.001) and had higher Charlson comorbidity index score ≥3 (46.6%-vs-36.8%, p&amp;lt;0.001). Multivariate analysis identified post-procedural hematoma (odds ratio (OR)=3.96; 95% Confidence Interval (CI)=3.46–4.54), congestive heart failure (CHF; OR=2.80, 95% CI=2.66–2.96), age group 45–60 years (OR=2.46, 95% CI=2.30–2.63), malnutrition (OR=1.99, 95% CI=1.85–2.15), coagulopathy (OR=1.75, 95% CI=1.64–1.86), end-stage renal disease (OR=1.65, 95% CI=1.53–1.78), atrial fibrillation (OR=1.42; 95% CI=1.35–1.49), non-Hispanic race (OR=1.25; 95% CI=1.16–1.36), coronary artery disease (OR=1.21; 95% CI=1.15–1.26), and thyroid disease (OR=1.15; 95% CI=1.09–1.12) [all p&amp;lt;0.001] as independent predictors of DI. Prevalence of CHF, malnutrition, and atrial fibrillation increased in those admitted with DI over the observation period as shown in Figure 1 (p for trend &amp;lt;0.001). Prevalence of diabetes mellitus also increased during the observation period although it was not an independent predictor of DI (p for trend &amp;lt;0.001). Pulmonary embolism and deep vein thrombosis were most common complications in those with DI (4.1 and 3.6% respectively). Annual in-hospital mortality ranged from 3.9 to 5.7% (mean 4.4%, p for trend=0.07). Conclusion DI is relatively common and continues to be associated with high morbidity and mortality. Prevalence of DI has not changed significantly despite technical and technological advances in device implantation. Evaluation of risk factors for DI and management of modifiable comorbidities may be needed to reduce the incidence of this important complication of CIED implantation. Funding Acknowledgement Type of funding sources: None.

Long-term morphological appearance of transcatheter valves left in the ascending aorta after valve dislocation during transcatheter aortic valve implantation

Abstract Background Transcatheter valve embolization and migration (TVEM) is a potential complication of transcatheter aortic valve implantation (TAVI) (1). Registries suggest low incidence but clinical relevance due to increased acute and mid-term mortality with the majority embolizing in the aorta. However, there is little data on potential late complications such as leaflet and stent thrombosis or aortic wall alterations by migrated valves. Purpose The aim of our study was to analyze the incidence and clinical characteristics of TVEM in a large single center cohort of TAVI patients and to examine dislocated valves by ECG-gated computed tomography (CT). Methods and results Between July 2009 and May 2020, 40 TVEM occurred in 3387 TAVI procedures performed in our center (1.18%). TVEM was defined according to Valve Academic Research Consortium-2 (VARC-2) criteria (3). Majority of TVEM were left in the ascending aorta (31 ascending, 3 arch, 1 descending aorta). 90% of TVEM occurred with a self-expanding valve (SEV), with no difference between older and newer valve generations, 10% with a ballon-expandable valve. Analyzing a TAVI sample cohort (n=200), horizontal aorta (p&amp;lt;0.001, OR 11.7, 95% CI: [3.9:34.8]), defined as aortic angulation &amp;gt;48°(4), as well as the use of SEV (p&amp;lt;0.001, OR 12.8, 95% CI: [3.1:53.9]) were identified as a predisposing risk factor for TVEM. OR in SEV was severely increased when isolating the analysis for patients with horizontal aorta only (p=0.003, OR 23.75, 95% CI: [2.8:129]). No other predisposing risk factors were identified in this cohort. Out of 35 patients still alive, 6 patients were willing to participate in our imaging sub-study. CT exams were performed on average 47 months after TAVI (IQR 50 months [25%Q: 16.8, 75%Q: 72.8]). We detected no leaflet or stent thrombosis, yet CT identified pin protrusions in the aorta in 3 out of 6 patients. Conclusions TVEM is a rare complication of TAVI. TVEM was significantly associated to the use of self-expanding valves and the presence of horizontal aorta. CT did detect pin protrusions in several cases which could bear the possible risk of perforation but showed no signs of long-term damage. Funding Acknowledgement Type of funding sources: None. Representative CT images after TVEM