Risk Of Pacemaker Implantation Research Articles

Risk of Pacemaker Implantation After Degenerative Mitral and Concomitant Tricuspid Valve Surgery

A recent multicenter trial showed a reduction in tricuspid regurgitation (TR) progression when tricuspid annuloplasty was performed at the time of surgery for degenerative mitral regurgitation (MR), but with a 14% pacemaker (PPM) rate. We present real-world outcomes at a high-volume center for degenerative MR surgery with/without tricuspid annuloplasty. Patients undergoing first-time degenerative mitral surgery between 2011-2021 were identified (n=1,738). After excluding patients undergoing aortic, aortic valve, or tricuspid replacement procedures, patients were stratified into mitral surgery alone (n=1,068) versus mitral surgery plus tricuspid annuloplasty (n=417). Outcomes including operative mortality, new PPM implantation, and postoperative length of stay as well as risk-adjusted overall mortality were compared. Among 1,485 patients in this study, 98% underwent mitral repair. Compared to concomitant tricuspid annuloplasty patients, those undergoing mitral surgery alone were 6 years younger and had lower median STS PROM. Among concomitant tricuspid repair patients, 85% (355/417) had moderate or less preoperative TR, while 15% (61/417) had severe TR. Operative mortality was 1.4%. The incidence of new PPM implantation was 0.7% (7/1,068) in the mitral only group and 5.5% (23/417) in the concomitant tricuspid group (p<0.001). Although unadjusted cumulative survival was lower in the concomitant tricuspid group, after risk adjustment, concomitant tricuspid surgery was not associated with worse overall mortality (HR 0.80 [95% CI, 0.53-1.19], p=0.27). Concomitant tricuspid annuloplasty is safe, with no difference in mortality and a less than 6% PPM rate at a high-volume mitral center. These data provide real-world context for concomitant tricuspid annuloplasty.

Cerebral Embolic Protection Device protects against stroke during Transcatheter Aortic Valve Replacement (TAVR): An Updated Meta-Analysis

Abstract Background Cerebral Embolic Protection Device (CEPD) is used to capture emboli during Transcatheter Aortic Valve Replacement (TAVR). Previous meta-analyses have yielded conflicting results regarding efficacy and safety of CEPD in TAVR. With recently published pivotal trial and multiple Cohort studies reporting new data, there is a need of re-calibration of available statistical evidence. Aims The aim of our study was to explore the effects of using CEPD on TAVR outcomes. Methods A systematic literature search was conducted across Pubmed, Cochrane, Embase, and clinicaltrials.gov from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR) while continuous outcomes were pooled using Standardized Mean Difference (SMD). Revman 5.4 was used to pool the data using random effects model With Mantel-Haenszel method. Subgroup analysis for study type (RCT vs NRS) was conducted. Sensitivity analysis using leave one out method and multiple exit method was conducted to find out, if unadjusted cohort studies had an impact on the pooled outcomes. Results The initial search revealed 870 articles. After primary and secondary screening, data was included from 17 studies (6 RCTs, 11 cohorts, n= 180187). Use of CEPD was associated with 50% reduced odds of stroke (OR=0.50, 95% CI=0.03-0.75, p=&amp;lt;0.01, I2=32%). There was no significant difference in 30 days mortality between the two groups (OR=0.76, 95% CI=0.44-1.31, p=0.33, I2=18%). On Diffusion Weighted Magnetic Resonance Imaging (DW-MRI), the two groups did not have any significant differences in volume per lesion (SMD=-0.07,CI=-0.28-0.14, p=0.52,I2=71%), Total volume of lesions (SMD=-0.08, p=0.73, CI=-0.53,0.17, I2=84%) and Number of lesions per patient (SMD=-0.15, p=0.45, CI=-0.23,0.10, I2=84%). On subgroup analysis, RCTs were found to have high heterogeneity while NRS had zero heterogeneity. The pooled analysis revealed no significant association with either of the group regarding Acute Kidney Injury (OR=0.84, p=0.43,I2=0%), risk of pacemaker implantation (OR=1.17,p=0.35,I2=0%), major bleed (OR=0.97,p=0.94,I2=62%), Worsening National Institute of Health Stroke Scale (NIHSS) (OR=0.46,p=0.36,I2=76%), and Vascular complications VC (OR=0.85,p=0.35,I2=0%). The results remained insignificant for subgroup analysis for study type and sensitivity analysis using leave one out and exit multiple methods for unadjusted cohort studies. Conclusion The use of CEPD during TAVR was found to be associated with reduced risk of stroke, however, there was no significant association with mortality, DW-MRI findings, AKI, major bleed, minor bleed, risk of pacemaker implantation, worsening NIHSS score and vascular complications. Further, large scale prospective trials are needed to provide definitive evidenceFig 1:Plots for mortality and strokeFig 2:Plots for VC and AKI

Association Between Left Ventricular Apical-to-Basal Strain Ratio and Conduction Disorders after Aortic Valve Replacement

The aim of the study was to evaluate whether left ventricular apical-to-basal longitudinal strain differences, representing advanced basal interstitial fibrosis, are associated with conduction disorders after aortic valve replacement (AVR) in patients with severe aortic stenosis. Patients with aortic stenosis undergoing AVR were included. The apical-to-basal strain ratio was calculated by dividing the average strain of the basal segments by the average strain of the apical segments. Values >1.9 were considered abnormal, as previously described. All patients were followed-up for the occurrence of complete left or right bundle branch block, or permanent pacemaker implantation within 2 years after AVR. Subgroup analysis was performed in patients undergoing transcatheter AVR. Two hundred seventy-four patients were included (74 years (IQR 65, 80), 46.4% male). During a median follow-up of 12.2 months (IQR 0.2, 24.3), 74 patients (27%) developed complete bundle branch block or were implanted with a permanent pacemaker. These patients more often had an abnormal apical-to-basal strain ratio. Cumulative event-free survival analysis showed worse outcome in patients with an abnormal apical-to-basal strain ratio (Log rank χ2 7.258, p = 0.007). In multivariable cox regression analysis, an abnormal apical-to-basal strain ratio was the only independent factor associated with the occurrence of complete bundle branch block or permanent pacemaker implantation after adjusting for other factors previously shown to be associated with conduction disorders after AVR. Subgroup analysis confirmed the independent association of an abnormal apical-to-basal strain ratio with conduction disorders after transcatheter AVR. The apical-to-basal strain ratio is independently associated with conduction disorders after AVR and could guide risk stratification in patients potentially at risk for pacemaker implantation.

Abstract 13416: Evaluation of Risk Factors for Pacemaker After Tavr Among Patients With a Pre-Existing Right Bundle Branch Block

Background : Pacemaker implantation (PMI) remains a common complication after TAVR. While a pre-existing right bundle branch block (RBBB) is consistently the strongest reported risk factor for PMI, most patients with a RBBB will not require PMI after TAVR. Objective : To identify factors associated with a higher risk of PMI after TAVR among patients with pre-existing RBBB. Methods : We identified all patients at a single institution undergoing first-time TAVR with a balloon-expandable prosthesis without a pre-existing pacemaker or ICD, and pre-existing RBBB (defined as RBBB morphology with QRS &gt;=110ms) from December 2013 to December 2020 (n=219). We evaluated the univariate association for numerous clinical, EKG, imaging, and procedural characteristics with PMI. We included all factors with p=&lt;0.10 in a logistic regression model to assess for independent associations with PMI in the original cohort and 1000 bootstrapped samples. Results : A history of syncope, body mass index, calcium channel blocker use, baseline PR interval, and prosthesis oversizing &gt;16% were associated with PMI on univariate analysis. When included in a logistic regression model, syncope (OR 3.2, 95%CI: 1.1-8.8, p=0.027) and oversizing (OR 3.1, 95% CI: 1.4-6.8, p=0.005) remained independently associated with PMI. These findings were consistent in the bootstrapped samples. Those with both factors (n=4) had a PMI rate of 75% which was higher compared to those with one or neither (43% and 22%, respectively; p&lt;0.001). Conclusion : Among those with pre-existing RBBB, a history of syncope and prosthesis oversizing &gt;16% were independently associated with a higher risk of PMI. These findings warrant external validation.

Incidence and risk factors for pacemaker implantation in light chain and transthyretin cardiac amyloidosis

Abstract Background The incidence and risk factors of pacemaker (PM) implantation in patients with cardiac amyloidosis (CA) are largely unexplored. Purpose We sought to characterise the trends in the incidence of permanent PM and to identify baseline predictors of future PM implantation in light chain (AL) and transthyretin (ATTR) CA. Methods Multicentre, retrospective, observational study. Consecutive patients with AL and ATTR-CA diagnosed or referred at participating Centres between 2017 and 2020 were included. Clinical data recorded within ± 1 month from baseline evaluation were collected from electronic medical records. The primary outcome of the study was the need for clinically-indicated PM implantation. Reversible causes of conduction system disease were systematically ruled out before PM implantation. Patients with PM (n=41) and/or permanent defibrillator in situ (n=13) at the time of CA diagnosis were excluded. Results The study population consisted of 405 patients: 29.4% AL, 14.6% variant ATTR and 56% wild-type ATTR; 82.5% were males, with median age 76 years. During a median follow-up of 33 months (interquartile range 21–46), 36 (8.9%) patients experienced the primary outcome: 10 patients with AL-CA, 2 with variant ATTR-CA and 24 with wild-type ATTR-CA (p=0.08). At multivariable analysis, history of atrial fibrillation (hazard ratio [HR] 3.80, p=0.002), PR interval (HR 1.013, p=0.002) and QRS &amp;gt;120 ms (HR 4.7, p=0.001) on baseline ECG were independently associated with PM implantation (Figure 1). In the individual patient, the contemporary presence of these 3 factors yielded the highest risk of PM implantation (HR 6.26, p=0.003). Conclusion In a large cohort of AL and ATTR-CA, the incidence of PM implantation was high accounting for ≈9% of patients in the 3 years following the diagnosis. History of atrial fibrillation, longer PR interval and QRS &amp;gt;120 ms identified CA patients at high-risk of future PM implantation (Figure 2). CA patients with these features might need close monitoring during follow-up for the development of conduction system disease requiring PM implantation. Funding Acknowledgement Type of funding sources: None.

Risk of pacemaker implantation after radiotherapy for breast cancer: A study based on French nationwide health care database sample.

BackgroundAmong cardiac complications of breast cancer radiotherapy (BC RT), there are very limited data on arrhythmia and conduction disorders, in particular severe cases requiring permanent pacemaker implantation (PPMI). Therefore, this exploratory study aimed to evaluate the risk of PPMI for BC patients treated with RT, compared with the general population and with BC patients not treated with RT.MethodsThe study was performed on a 1/97 representative sample of the French health care database (EGB database). Adult women with a first BC treated with or without RT between 2008 and 2016 were included, followed until 2018, and de novo PPMI were identified. We compared the PPMI incidence in BC cohort relative to the general population with standardized incidence ratio (SIR) and evaluated the risk of PPMI in RT patients compared to patients without RT with a competing risk survival analysis.ResultsA total of 3853 BCE patients were included. Among BC patients treated with RT, 28 PPMI cases were observed compared with 13 expected cases, corresponding to a SIR of 2.18 [95% CI: 1.45–3.06]. For BC patients not treated with RT, the SIR was 1.01 [95% CI: 0.40–1.90]. Patients treated with RT showed a borderline significant higher risk of PPMI compared with those not treated with RT (subdistribution Hazard Ratio = 2.08, 95% CI 0.87–4.97, p = 0.09).ConclusionsOur exploratory findings indicate that, over the last decade in France, BC patients treated with RT appeared to be at higher risk of PPMI than general population. Further studies are needed to expand on this topic.

Breast cancer radiotherapy and risk of pacemaker implantation: an epidemiologic analysis using the French nationwide claims database

Abstract Background Radiotherapy (RT) is a major treatment for breast cancer (BC), but it is also associated with an increased long-term (&amp;gt;5–10 years) risk of cardiac complications. Specific data on cardiac arrhythmias and conduction disorders are warranted. Purpose To evaluate whether pacemaker (PM) implantation risk is higher in BC patients treated with RT compared to the general population or population of BC patients treated without RT. Methods Our study was based on the Echantillon Généraliste de Bénéficiaires (EGB), the 1/97 random sample of the French nationwide health insurance claims database. The population of patients treated for BC consisted of adult women with a first BC identified by the ICD-10 diagnosis codes between 2008 and 2016, and followed through 2018. PM implantations and RT were identified with medical procedures codes in the french Common Classification of Medical Procedures (CCAM). For each year from 2008 to 2018, the reference population included all adult women of the EGB database. History of PM or BC was an exclusion criteria. Annual incidence rates of PM implantations were evaluated between 2008 and 2018 in the reference populations. The number of PM cases observed in BC patients at least one year after BC diagnosis was compared with the expected number of PM cases calculated by using reference incidence rates with age standardization. We then computed the standardized incidence ratio (SIR) as the ratio of the observed number of PM to the expected number of PM, with 95% confidence intervals (CIs). Thereafter, a survival analysis was performed in BC patients using a Cox regression model (Hazard Ratio – HR) in order to evaluate the risk of PM associated with treatment including RT (RT) compared with treatment not including RT (no RT). Results A total of 3,853 patients were included in the population of patients treated for BC between 2008 and 2016 with a mean age of 60 years old and a mean follow-up of 5.6 years. In this population, 35 cases of PM were observed, compared with 19.9 expected cases of PM, corresponding to a significant SIR=1.76 (95% CI: 1.22 - 2.39). This excess risk was carried by the RT group of 2973 patients (77% of BC population): 28 observed PM vs 12.9 expected, SIR=2.18 (95% CI: 1.45–3.06). In Cox regression analysis, after adjustment on age, RT was associated with an increased risk of PM compared with no RT, but this result did not reach statistical significance (HR=1.73; p-value=0.21). Conclusion Based on our study, BC patients receiving RT appeared to be at higher risk of PM implantation than general female population and BC patients without RT, illustrating a potential association between cardiac exposure during BC RT and conduction disorders. Funding Acknowledgement Type of funding sources: None.

New Onset of AV- Nodal Reentrant Tachycardia (AVNRT) in the elderly – an uncommon diagnosis?

Abstract Background Arrhythmias in elderly patients (&amp;gt;70 years) are common in daily clinical practice. Most frequently, they are based on atrial fibrillation or other atrial tachycardia with an indication for oral anticoagulation and specific antiarrhythmic medications. The electrographic (ECG) documentation related to symptoms is essential before therapy initiation. In case of suspected AVNRT based on surface ECG, an electrophysiological study (EP) with ablation as curative strategy should be planned. Methods We analysed all patients &amp;gt;70 years with AVNRT diagnosed by electrophysiologic (EP) studies between May 2018 and December 2020. Results An EP study for suspected AVNRT was performed in 27 patients &amp;gt;70 years. The diagnosis of AVNRT was confirmed in 20 patients (75%). From all EP- studies with the diagnosis of AVNRT (n=93) in this period, 20 patients (22%) were older than 70 years (mean age 77 years with a range of 70–85 years), 12 were women. In most of the patients, the duration of symptoms was short (3 month). Only 4 patients had symptoms of paroxysmal tachycardia longer than 10 years. Except for 2 patients, all patients had at least one ECG- documentation (12- lead- ECG, Holter- ECG, telemetric ECG and/or in the loop recorder). In 12 patients, a 12- lead- ECG- documentation was available, in 5 patients the tachycardia has been registered in the Holter-ECG and in 1 in a loop recorder. In the 12- lead- ECG before ablation in sinus rhythm the PQ interval was with 196 (120- 300) ms in the upper range. In 16/ 20 patients was during the EP- study a sustained AVNRT (CL 410, 314- 538 ms) inducible. In the others, up to 3 typical AV- nodal- echo beats were induced in the EP- study. A slow pathway ablation/ modification was performed in all patients in typical position. In 2 patients, the implantation of a dual- chamber- pacemaker was necessary due to intermittent high- degree AV-nodal-block during the same hospital stay. In both patients, a first degree AV-block with PQ- interval of 250 and 300 ms was pre-existing. Discussion Especially for the elderly patients with new onset of clinical symptoms of arrhythmia, clinical anamnesis including an ECG- documentation is required for planning the therapeutic strategy. A borderline long PQ- interval as sign of an age- dependent fibrosis in the AV- node and, therefore, altered conduction properties in the AV node can be a cause of AVNRT in these older patients. In patients with pre-existing long PQ- interval (&amp;gt;250 ms), the risk of pacemaker implantation after successful ablation is higher. In this group of patients, medical therapeutic options are limited and often associated with the need of pacemaker implantation. Funding Acknowledgement Type of funding sources: None.

Relationship between septo-valvular angle and risk of pacemaker implantation after transcatheter aortic valve implantation: a preliminary study.

Pre-transcatheter aortic valve implantation (TAVI) computed tomography (CT) has proven to be crucial in identifying pre- and post-procedural predicting factors predisposing the onset of major arrhythmias that require permanent pacemaker (PPM) implantation caused by the compressive effects of the prostheses on the conduction system at the membranous septum (MS) and the muscular crest of the interventricular septum.Our analysis aims to verify if the pre-TAVI assessment of the angle between the MS and the aortic annulus (SVA) might be a predictive factor for the onset of arrhythmias that requires PPM. Two cardiovascular specialist radiologists retrospectively and double-blind evaluated a randomized list of preprocedural CT of 57 patients who underwent TAVI with a self-expandable valve from April 2019 to February 2020. Two anatomical features were measured by readers: width of the SVA and MS length (MSL). A PPM was implanted in 18 patients (31%) after the procedure. There was no significant difference in the anatomical measurements performed between the two observers, regarding both anatomical measurements (intraclass correlation coefficient was 0.944 for the SVA and 0.774 for the MSL]. Receiver-operating characteristic curves (ROC) performed for both measurements have documented: for the SVA sensitivity 94% and Negative predictive value (NPV) 96% (area under the curve: 0.77; 95% confidence interval 0.66-0.90). The MSL ROC was not significant. The mean SVA value stratified for patients who did not undergo PPM implantation and patients who did resulted as significant (P < 0.005). Measurement of the SVA performed in preprocedural CT scans has proven to be related to the onset of major arrhythmias after TAVI requiring permanent pacemaker implantation with high sensitivity (94%) and NPV (96%).

Risk of Pacemaker Implantation after Radiotherapy for Breast Cancer: A Study Based on French Nationwide Health Care Database Sample

Risk of Pacemaker Implantation after Radiotherapy for Breast Cancer: A Study Based on French Nationwide Health Care Database Sample

Risk of pacemaker implantation in patients treated for breast cancer: A study based on French nationwide health database sample

Cardiotoxicity of some medical anti-cancer treatments and radiotherapy for breast cancer (BC) patients is well known, but knowledge for conduction disorders or sinus node disease remains poor. To examine the risk of pacemaker (PM) implantation subsequent to BC treatment by comparing PM incidence in BC patients to that in the general population on an age-specific basis. Our study was based on the Échantillon généraliste de bénéficiaires (EGB), the 1/97 random sample, the French nationwide health database (SNDS). The study population consisted of adult women treated for a primo BC between 2008 and 2014, with no previous history of PM implantation, followed until 2016. For each year from 2008 to 2016, the reference population included all women present in the EGB with no PM or BC implantation. PM implantations were identified according to the Classification commune des actes médicaux . The standardised incidence ratio (SIR) was calculated as the ratio of the observed number of PM in the BC population to the expected number of PM computed using annual age-specific PM incidence rates from the reference population, weighted according to the age structure of the BC population. Between 2008 and 2016, the annual reference population consisted of nearly 193,000 individuals with an incidence rate of PM implantation that varied from 1case/100,000 in the younger category (< 40 years) to 552 cases/100,000 for women ≥ 85 years. The BC population included 2821 patients (approximately 400 per year, 50% aged > 60 years) in whom 18 PM implantations were observed compared with 11.5 expected yielding a SIR of 1.56 (95% CI: 0.93–2.36), indicating a 56% higher incidence of PM in the BC population. These preliminary results indicate that treatment for BC may be associated with an increased risk of PM implantation. Further analysis according to the type of treatment (radiotherapy, chemotherapy…) is ongoing.

The effects of transcatheter aortic valve implantation on cardiac electrical properties

IntroductionTranscatheter aortic valve implantation (TAVI) is associated with cardiac electrical disturbances. However, beyond the risks of pacemaker implantation, few studies have performed a detailed assessment of the effects of TAVI on several cardiac electrical properties. ObjectivesTo assess the frequency and type of electrocardiographic disturbances following TAVI, according to the type of prostheses and to assess predictors of these disturbances. MethodsWe performed a detailed retrospective analysis of all electrocardiograms in patients who underwent TAVI, before and after the procedure, at a tertiary center from August 2007 to October 2016. Patients with permanent pacemakers were excluded. ResultsWe included 182 patients (78±8 years; 56% female) and self-expanding prostheses (SEP) were implanted in 54%. Most patients (80%) were in sinus rhythm at baseline. After TAVI, 21% of patients developed new-onset atrial fibrillation and there was a significant increase in PR interval at discharge (186±41 ms vs. 176±32; p=0.003), which was not maintained after at six-month follow-up (181±35 ms, p=0.06). There was also a significant increase in QRS duration at discharge (129±28 ms vs. 114±25 at baseline p<0.0001), which persisted at six-months (122±28 ms, p<0.0001). New-onset left-bundle branch block (LBBB) was observed in 25% of patients. The depth of valve implantation was a predictor of new LBBB at discharge after multivariate analysis (OR 37.6, 95% CI 14.6–65.2, p=0.001). ConclusionsThe main electrocardiographic disturbances post TAVI were PR prolongation, increased QRS and new-onset LBBB. These disturbances were more pronounced in patients undergoing SEP implantation and tended to improve at six-month follow-up. The depth of valve implantation was a predictor of conduction disturbances.

Corticosteroid treatment before TAVI and the risk of pacemaker implantation: A 2:1 matching study

Conductive disorders after TAVI remain frequent, leading to a 10-20% risk of permanent pacemaker implantation (PPI). Pre-existing conduction disorders or anatomical features can offer a good prediction of the risk of PPI, however, inflammatory and hemorrhagic process are responsible of transient abnormalities and 1/3 of the patients does not need the pacemaker at follow-up. In this setting, corticosteroid could be an interesting treatment to prevent or reduce the need of PPI. We aim to assess the influence of chronic or acute corticosteroid treatment in the occurrence of PPI after TAVI. All TAVI performed in our center 2013 and 2018 were prospectively included in the study. Patient treated either with chronic or acute corticosteroid before TAVI were gathered through medical database claim of the University Hospital of Dijon, France. They were matched 1:2 on sex, age, and the valve implanted. Preoperative parameters, corticosteroids dose and indication, and PPI rates after TAVI were collected. Among the 691 patients included, 18 (2.6%) patients had a corticosteroid prescription before TAVI procedure. 11(61%) had a chronic corticosteroid prescription, when the remaining patients were treated before and a few days after TAVI as prevention of contrast iodinated product allergy. When compared to the matched population ( n = 36), no significant difference was found on PPI rates during hospitalization (2 (11%) vs. 6 (17%), P = 0.70). Among others parameters collected, the only significant difference between the two groups was that corticosteroids patients less frequently had previous diabetes (3 (17%) 17 vs. 18(50%), P = 0.021). Corticosteroid treatment is uncommon before TAVI, reducing the statistical power of this analysis. Given the safety of this drug prescription on short duration prescription, a prospective randomized study could be performed to confirm our hypothesis.

2211Prevalence, incidence and prognostic implications of left bundle branch block in patients with stable coronary artery disease. an analysis from the CLARIFY registry

Abstract Background The prevalence, and prognostic implication of left bundle branch block (LBBB) in general population and patients admitted for acute myocardial infarction (MI) as been extensively studied. However, data are scarce about patients with stable coronary artery disease (CAD) and it remains unclear whether LBBB is only a marker of a severe cardiomyopathy or an independent predictor of events in these patients. Purpose We aimed to describe the prevalence, incidence and prognostic implications of LBBB in patients with stable CAD. Additionally, we aimed to describe the incidence of newly diagnosed LBBB that occurred without recent myocardial infarction. Methods CLARIFY is an international registry of more than 30.000 patients with stable CAD. LBBB was collected at baseline and at each follow-up visit, and patients were considered to have LBBB if the length of the QRS complex was of more than 120 milliseconds. Patients with previous pacemaker implantation of internal cardiac defibrillator were excluded. The primary outcome was a composite of cardiovascular (CV) Death, MI or stroke, and secondary outcomes included hospitalization for heart failure (HF) or the need for pacemaker implantation. Results From the 23.457 patients with available data regarding LBBB status, 1.041 (4.4%) had LBBB at baseline and 1.237 (5.3%) had at least one LBBB assessed during 5-year follow-up. Only 21 patients with newly diagnosed LBBB overtime, had a documented MI the same year. Compared to patients without LBBB, patients with LBBB had a higher risk profile regarding age (67.2±10.1 versus 63.6±10.4 years, p&lt;0.0001), history of coronary artery bypass grafting (29.2% vs 23.7%, p&lt;0.0001), diabetes (35.1% vs 28.4%, p&lt;0.0001), and HF (25.2% vs 16.8%, p&lt;0.0001) (Table). In unadjusted analysis, patients with LBBB had a higher risk of primary outcome (13.4% vs 8.7%, p&lt;0.0001) and each secondary outcome. In multivariate analysis taking into account several possible confounders, there was no difference in the rate of CV death, MI or stroke between LBBB or no-LBBB patients (adjusted HR 1.04, 95% CI 0.85–1.29). However, patients with LBBB had a higher rate of pacemaker implantation (adjusted HR 2.21, 95% CI 1.55–3.15, p&lt;0.0001) and hospitalization for HF (adjusted HR 1.53, 95% CI 1.25–1.88, p&lt;0.0001) (Figure). Outcomes according to LBBB status Conclusion The prevalence of LBBB in patients with stable CAD was 4.4% and 5.3% with 5-year follow-up. The overwhelming majority of newly diagnosed LBBB were not contemporary of documented myocardial infarction. LBBB was not associated with a higher rate of major adverse cardiovascular events, including all cause mortality but with a higher risk of pacemaker implantation and hospitalization for heart failure. To our knowledge this is the first study reporting such results in a broad population of stable CAD patients. Acknowledgement/Funding None

Etiology of tricuspid valve disease is a predictor of bradyarrhythmia after tricuspid valve surgery.

The tricuspid valve is situated in close proximity to cardiac conduction tissue and damage to this tissue can affect postoperative rhythm. The aim of this study was to quantify the incidence of pacemaker requirement after tricuspid valve surgery and investigate predictors. Data were collected via our operative data collection system and patient files. All patients who underwent surgical procedures of the tricuspid valve from 2004 until 2017 and lacked a pacemaker preoperatively were included in the study. In our cohort of 505 patients 54 required a pacemaker in the first 50 days after surgery. We calculated a 17.5% (95% confidence interval [CI], 13.5-21.3) risk of pacemaker implantation at 4 years postoperatively. Multivariate analysis identified preoperative active endocarditis (odds ratio 3.17; CI, 1.32-7.65; P = 0.010) and "inadequate pacemaker dependent rhythm" (defined as any intrinsic heart rate below 45 per minute requiring pacing) upon admission to the intensive care unit after surgery (odds ratio 5.924; CI, 2.82-12.44; P = 0.001) as predictors for pacemaker requirement in the first 50 days after surgery. Twenty-six pacemakers (48%) were implanted for atrioventricular block, 16 (30%) for sinus node dysfunction and 12 (22%) for atrial fibrillation. Kaplan-Meier analysis showed no difference in survival between the pacemaker and no pacemaker group. Surgery of the tricuspid valve has a high burden of postoperative pacemaker requirement. Preoperative active endocarditis and the initial postoperative rhythm are predictors. Understanding this allows for better decision-making regarding further medical/device therapy.

P455Rate lowering and anti-arrhythmic drugs as monotherapy or dual therapy on the risk of pacemaker implantation in patients with atrial fibrillation

P455Rate lowering and anti-arrhythmic drugs as monotherapy or dual therapy on the risk of pacemaker implantation in patients with atrial fibrillation

22 Incidence and predictors of permanent pacemaker insertion after perceval sutureless aortic valve implantation – a retrospective single-centre study

Background Sutureless aortic valve replacement surgery (SAVR) is considered in patients with aortic stenosis who would benefit from reduced cross clamp time, such as elderly and high-risk patients. It serves as an alternative surgical approach to standard surgical AVR and TAVI (Figure 1). Objective The purpose of this study was to evaluate the incidence of PM implantation following sutureless aortic valve replacement using the Perceval S bioprosthesis (Sorin Group, Saluggia, Italy). In addition we sought to evaluate whether there were any pre-operative predictive indicators to identify those patients at higher risk of PM implantation using this technique. Methods During the study period a total amount of 58 consecutive patients (male 43%, age 77.9 ± 4.9 years) with severe aortic stenosis having undergone SAVR were included. Twenty-eight patients (48%) underwent an isolated AVR procedure; in the rest of study population AVR was performed in combination with coronary artery bypass graft (CABG) in 26 patients (45%), surgical pulmonary vein isolation in 2 (3%), tricuspid valve replacement (TVR) in 1 (2%) and both TVR and mitral valve replacement (MVR) in 1 (2%). Full median sternotomy was performed in all patients. Results During a mean follow up of 13.8 ± 5.0 months (median 13 months), 14 patients (24.1%) underwent dual-chamber pacemaker (PM) implantation after the SAVR procedure. The mean time to PM implantation was 5.4 ± 3.6 days (median 5 days). Ten out of 14 (71%) were found completely PM-dependent after PM implantation. The comparison of pre-operative characteristics between PM group and no PM group highlighted that QRS duration, EuroSCORE II index and chronic renal dysfunction were significantly associated with postoperative PM implantation (respectively, p = 0.01, p = 0.02 and p = 0.03). Conclusions In conclusion, we have found that chronic renal disease and QRSd are significant predictors of PM insertion post-Perceval SAVR.

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis.

The comparative benefits and harms of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for patients with aortic stenosis are unclear. To compare clinical outcomes, including early (≤30-day) and midterm (≤1-year) mortality, in adults with severe aortic stenosis undergoing either TAVI or SAVR. MEDLINE, Cochrane, and Scopus databases (without language restrictions) from April 2002 to 5 April 2016; multiple registries and Web sites; scientific meeting presentations. Five randomized trials and 31 observational matched studies comparing mortality outcomes after TAVI or SAVR. Two investigators independently extracted study data and rated risk of bias. 16638 patients were analyzed. Overall, there was no statistically significant difference between TAVI and SAVR in early (odds ratio [OR], 1.01 [95% CI, 0.81 to 1.26]) or midterm (OR, 0.96 [CI, 0.81 to 1.14]) all-cause mortality. Analyses restricted to trials (early: OR, 0.80 [CI, 0.51 to 1.25]; midterm: OR, 0.90 [CI, 0.64 to 1.26]) were inconclusive, with wide CIs, whereas analyses of matched studies were similar to the overall results. Transfemoral TAVI provided mortality benefits over SAVR in trials. Analyses restricted to studies of patients at low to intermediate risk showed statistically nonsignificant reductions in early (OR, 0.67 [CI, 0.42 to 1.07]) and midterm (OR, 0.91 [CI, 0.67 to 1.23]) mortality with TAVI. Incidence of periprocedural myocardial infarction, major bleeding, acute kidney injury, and new-onset atrial fibrillation was lower with TAVI, but risk for pacemaker implantation, vascular complications, and paravalvular leak increased. Overall, there was a statistically nonsignificant increased risk in long-term (2- to 5-year) all-cause mortality with TAVI (OR, 1.28 [CI, 0.97 to 1.69]), whereas long-term mortality outcomes in patients at low to intermediate risk were inconclusive, with wide CIs (OR, 1.06 [CI, 0.59 to 1.91]). The number of trials was limited, and study designs and patient characteristics were heterogeneous. Compared with SAVR, TAVI may have similar or better early and midterm outcomes for adults with aortic stenosis, including those at low to intermediate risk. None.

Pacemaker implantation after catheter ablation for atrial fibrillation.

Sinus node dysfunction requiring pacemaker implantation is commonly associated with atrial fibrillation (AF), but may not be clinically apparent until restoration of sinus rhythm with ablation or cardioversion. We sought to determine frequency, time course, and predictors for pacemaker implantation after catheter ablation, and to compare the overall rates to a matched cardioversion cohort. We conducted a retrospective analysis using a large US commercial insurance database and identified 12,158 AF patients who underwent catheter ablation between January 1, 2005 and December 31, 2012. Over an average of 2.4 years of follow-up, 5.6 % of the patients underwent pacemaker implantation. Using the Cox proportional hazards models, we found that risk of risks of pacemaker implantation was associated with older age (50-64 and ≥65 versus <50 years), female gender, higher CHADS2 score (≥2 and 1 versus 0), higher Charlson index (≥2 versus 0-1), certain baseline comorbidities (conduction disorder, coronary atherosclerosis, and congestive heart failure), and the year of ablation. There was no significant difference in the risk of pacemaker implantation between ablation patients and propensity score (PS)-matched cardioversion groups (3.5 versus. 4.1 % at 1 year and 8.8 versus 8.3 % at 5 years). Overall, pacemaker implantation occurs in about 1/28 patients within 1 year of catheter ablation. The overall implantation rate decreased between 2005 and 2012. Furthermore, the risk after ablation is similar to cardioversion, suggesting that patients require pacing due to a common underlying electrophysiologic substrate, rather than the ablation itself.

Is pre-TAVI EP study useful to predict risk of post-procedure pacemaker implantation?

Introduction: Recent studies have shown that Transcatheter Aortic Valve Implantation (TAVI) can induced severe conduction disorders. However, the usefulness and the time of electrophysiology (EP) study is still unclear. Methods: This single-center prospective study took place from December 2010 to Mai 2012 and included 81 patients. An ECG was realized before, immediately after and 24 hours after the procedure along with the registry of the electric modifications during the procedure. EP study was realized before and/or after TAVI. A follow up at one month with an ECG and clinical advents has been realized. Results: Out of the 81 patients, 74% were implanted with an Edwards valve and 26% with a Corevalve. The pacemaker implantation rate was respectively 16% and 35% (p=0.03). 30% of them underwent an EP study before and after TAVI. Risk factors correlated to a higher risk of permanent pacing are male gender (p=0.04), pre-existing right bundle branch block (p 200 ms (p=0.008), QRS width >120 ms (p=0.01), left axis deviation (p=0.003), larger valve diameter (26mm vs 24mm; p=0.04), prolonged HV interval (67.7 vs 57 ms; p=0.01), Corevalve (p=0.03), and renal insufficiency (p=0.04). The HV interval was significantly prolonged after TAVI (58.9 ms to 68.8ms, p=0.007). None of the patients with an initial HV interval below 60ms was implanted with a pacemaker. Furthermore, no patient with a pre-TAVI QRS width below 120 ms and a HV interval below 65 ms necessitated pacemaker implantation with a 100% positive predictive value. Conclusions: Some clinical and EP factors seem to be identified as risk factors for the implantation of a pacemaker post TAVI, such as male gender, a pre-TAVI wide QRS particularly RBBB, a prolonged PR interval, chronic renal failure, a larger valve diameter and the use of a Corevalve. QRS width combined to a pre-TAVI EP study appears to predict the risk of pacemaker implantation. However, these results need to be confirmed by larger studies.