Risk Factors For Pacemaker Implantation Research Articles

Electrocardiographic changes after TAVR and their clinical impact according to new ESC Pacing Guidelines

Abstract Conduction disturbances after transcatheter aortic valve replacement (TAVR) remain one of the most frequent complications. The aim of this study was to analyze ECG changes after TAVR using contemporary valves and to detect risk factors for the need of further clinical evaluation according to new ESC pacing guidelines to evaluate pacemaker implantation. In this retrospective analysis we included 850 patients (mean age 80±9 years, 51% female), who underwent TAVR in our institution from January 2019 until December 2020. A mean follow-up of 8.9±8.4 months and 217 (25.5%) patients was performed. 55% of the implanted valves were self-expandable, 45% balloon-expandable. After TAVR, 77 (9.1%) patients developed new LBBB and QRS >150ms, 26 (3.1%) new PR-time >240ms. Prolongation of PR-time and prolongation of QRS duration >20ms were seen in 20 (2.4%) and 90 (10.6%) patients with preexisting conduction disturbances. 152 (17.9%) patients needed pacemaker implantation post TAVR. Developing a PR-prolongation of >20ms was associated with calcification of the annulus (OR 1.2 CI 95% 1.004–1.4; p=0.04). New LBBB (OR 0.45; CI 95% 0.25–0.79; p=0.006) and pacemaker implantation (OR 0.4; CI 95% 0.2–0.8; p=0.009) were correlated with the implantation of a self-expandable valve. Coronary heart disease (OR 3, CI 95% 1.07–8.2; p=0.04) and peripheral arterial disease (OR 2.6 CI 95% 1.18–5.6; p=0.02) were associated with prolongation of QRS >20ms. New LBBB with QRS >150ms was seen more often after post-dilatation (OR 1.03, CI 95% 1.01–1.05; p=0.05). Pre-existing AV block I° (OR 2.8, CI 95% 1.4–5.6; p<0.001), pre-existing RBBB (OR 20.5, CI 95% 7.5–56; p<0.001), nicotine abuse (OR 2, CI 95% 1.05–3.8; p=0.04), prosthesis oversizing (OR 1.06, CI 95% 1.006–1.11; p=0.03) and implantation depth (OR 1.13, CI 95% 1.006–1.26; p=0.04) were independent risk factors for pacemaker implantation. During the follow-up 161 patients (18.9%) were hospitalized in 270 inpatient stays [cardiac decompensation (n=36, 13%), pacemaker implantation (n=9, 3.3%), acute coronary syndrome (n=12, 4.4%)]. 8 patients (80%) received a pacemaker implantation because of AV Block III° and 1 (10%) patient because of sick-sinus-syndrome (SSS). Analyzing the post TAVR ECG 5 (50%) had a new LBBB (3 (30%) with QRS >150ms) and 4 (40%) patients showed LBBB together with AV Block I°. According to new guidelines 213 (25.1%) patients would have needed further clinical evaluation (EP study or ECG monitoring) after TAVR. AV-conduction abnormalities were associated with annulus calcification. Self-expandable valves were associated with new LBBB and pacemaker implantation. There seems to be a correlation between arteriosclerotic diseases and QRS width post TAVR. Pre-existing RBBB, AV block I°, implantation depth and prosthesis oversizing are important risk factors for pacemaker implantation post TAVR. New LBBB after TAVR is associated with a higher risk for pacemaker implantation in the long-term analysis. Funding Acknowledgement Type of funding sources: None.

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 >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 >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.

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

The incidence and risk factors of pacemaker (PM) implantation in patients with cardiac amyloidosis (CA) are largely unexplored. We sought to characterize 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. Consecutive patients with AL and ATTR-CA diagnosed at participating centres (2017-2020) were included. Clinical data recorded within ±1month from diagnosis were collected from electronic medical records. The primary study outcome was the need for clinically-indicated PM implantation. Patients with PM (n=41) and/or permanent defibrillator in situ (n=13) at CA diagnosis were excluded. The study population consisted of 405 patients: 29.4% AL, 14.6% variant ATTR and 56% wild-type ATTR; 82.5% were male, 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 AL-CA, 2 variant ATTR-CA and 24 wild-type ATTR-CA (p=0.08 at time-to-event analysis). 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 >120 ms (HR 4.7, p=0.001) on baseline electrocardiogram were independently associated with PM implantation. The absence of these three factors had a negative predictive value of 92% with an area under the curve of 91.8% at 6months. In a large cohort of AL and ATTR-CA patients, 8.9% received a PM within 3 years after diagnosis. History of atrial fibrillation, PR >200 ms and QRS >120 ms predicted future PM implantation.

Incidence of and risk factors for pacemaker implantation after the modified Cryo-Maze procedure for atrial fibrillation

ObjectivesThe Maze procedure is a well-established treatment for atrial fibrillation. However, it is sometimes associated with bradycardia requiring pacemaker implantation. We assessed the rates of in-hospital and late-onset pacemaker implantation after the modified Cryo-Maze procedure and explored the risk factors for pacemaker implantation. MethodsThis study enrolled a series of 751 patients who underwent the modified Cryo-Maze procedure at our institution between 2001 and 2020. Multivariable Fine-Gray regression was used to analyze the risk factors for late-onset pacemaker implantation. ResultsTwelve patients (1.6%) underwent in-hospital pacemaker implantation, and 55 patients (7.3%) underwent late-onset pacemaker implantation during a median follow-up of 4.5 years (interquartile range, 1.4-10.0). The most common primary indication for pacemaker implantation was sick sinus syndrome (56 patients [7.5%]), followed by complete atrioventricular block (11 patients [1.5%]). The cumulative incidence of late-onset pacemaker implantation with death as a competing risk was 2.8% at 1 year, 7.7% at 5 years, and 10.8% at 10 years. Risk factors for late-onset pacemaker implantation included a longer preoperative atrial fibrillation duration (hazard ratio, 1.14; P < .001) and an older age (hazard ratio, 1.05; P = .001). The mortality, cumulative incidence of cerebrovascular accidents, and rate of atrial fibrillation recurrence were not significantly different between patients with and without pacemaker implantation. ConclusionsLonger preoperative atrial fibrillation duration and older age are risk factors for late-onset pacemaker implantation after the modified Cryo-Maze procedure. However, the incidence of pacemaker implantation is not associated with increased morbidity or atrial fibrillation recurrence.

Short term clinical outcomes and analysis of risk factors for pacemaker implantation: a single center experience of self-expandable TAVI valves

ObjectivesTranscatheter aortic valve implantation is a recognized treatment for patients with severe aortic stenosis at all risk groups. However, permanent pacemaker rates remain high for self expandable transcatheter valves and permanent pacemaker implantation has been associated with increased morbidity. In this analysis we aim to evaluate short term clinical outcomes post self expandable transcatheter aortic valve implantation and determine risk factors for permanent pacemaker implantation.Methods88 patients with severe aortic stenosis with transcatheter aortic valve implantation performed between the year 2016–2018 were retrospectively analyzed. Outcomes of interest included 1- year all cause mortality, 30-day major adverse cardiovascular events, permanent pacemaker and paravalvular leak rates. Survival analysis was performed with Kaplan Meier analysis and risk factors for survival and permanent pacemaker rates were identified with log rank test and regression analysis.ResultsThe mean age of the cohort was 80.3 +/− 6.9 years. The mean STS score was 9.25. The 30 day all-cause mortality was 5.7% and 1-year all cause mortality was 16.7%. 80 patients had transfemoral transcatheter aortic valve implantation, and a majority of the patients (85.2%) were implanted with Corevalve Evolut R device. The device success rate was 88.6%. Multivariate analysis identified concomitant severe coronary artery disease (OR = 18.2 +/− 0.9; P = 0.002), pre transcatheter aortic valve implantation atrial fibrillation (OR = 8.6 +/− 0.91; P = 0.02) and post procedural disabling stroke (OR = 32.6 +/− 1.35; P = 0.01) as risk factors for 1-year mortality. The 30-day pacemaker rate was 17.6%. The presence of right bundle branch block (OR 11.1 +/− 0.86; P = 0.005), non-coronary cusp implantation depth (OR = 1.34 +/− 0.15; P = 0.05) and a non coronary cusp implantation depth / membranous septal length ratio of more than 50% were associated with post procedural pacemaker implantation (OR = 29.9 +/− 1.72; P = 0.05). Among the 15 patients with post procedural pacemaker implantation, 40% were found to be non-pacemaker dependent at 1 year.ConclusionShort term outcomes of transcatheter aortic valve implantation in severe aortic stenosis patients are promising. Pacemaker rates remain high. More studies are needed to evaluate the factors that influence pacemaker rates and dependence to further improve transcatheter aortic valve implantation outcomes.

Prevalence of and Risk Factors for Permanent Pacemaker Implantation After Aortic Valve Replacement

Damage to the cardiac conduction system requiring permanent pacemaker implantation is a complication of aortic valve replacement (AVR) that may importantly affect quality of life. We investigated the prevalence of and preprocedure risk factors for new permanent pacemakers after surgical (SAVR) and transcatheter AVR (TAVR) at a single institution. Preoperative variables and baseline electrocardiograms were reviewed for 5807 patients undergoing elective SAVR, with or without coronary artery bypass grafting, and 1292 undergoing TAVR, with or without percutaneous coronary intervention, from 2006 to 2017 at Cleveland Clinic. Patients with previous permanent pacemakers were excluded. Risk factors for permanent pacemaker implantation were identified using multivariable logistic regression analysis. New permanent pacemakers were implanted in 151 (2.6%) after SAVR and in 125 (9.7%) after TAVR (whole group SAVR vs TAVR, P <.0001). Risk factors forpacemaker implantation after TAVR included preoperative conduction disturbances and type of prosthesis (SAPIEN, 9.5%; SAPIEN XT, 4.8%; SAPIEN 3, 10% [Edwards Lifesciences, Irvine, CA]; CoreValve, 30% [Medtronic, Minneapolis, MN]; and other TAVR, 10%). There were no reliable risk factors for pacemaker implantationafter SAVR. Bicuspid valves, mechanical vsbioprosthetic valves, higher Society of Thoracic Surgeonsrisk score, and concomitant coronary artery bypass grafting were not associated with elevated risk. At a high-volume institution in the current era, establishing a baseline for pacemaker implantation after AVR is necessary. Preoperative conduction disturbances and transcatheter valve type affect its prevalence. These data provide a benchmark that should be taken into account when considering TAVR in low-risk patients.

Pediatric heart transplantation-What are the risk factors for pacemaker implantation and how much pacing is required?

In an attempt to improve pacemaker therapy after pediatric transplantation, we investigated risk factors, indication for pacing, and pacing burden after pediatric heart transplantation. In this retrospective study, 139 pediatric heart transplant recipients, of whom 122 did not and 17 did require pacemakers, were investigated. Eleven of the 17 patients requiring a permanent pacemaker (PPM) received their heart from a female donor (68.8%); this compares to 48 of 122 patients (43.2%, P = 0.082) in the group not requiring a pacemaker (No PPM). The donor age and height were significantly greater in the PPM group at a median of 25.26 years (16.29-48.00) and 160cm (153-170) compared with 11.96 years (1.73-19.95) and 141cm (89-165) in the No PPM group (P = 0.003 and 0.015, respectively). Of the 17 patients requiring pacemakers, 13 presented with sinus node dysfunction (SND) and four with atrioventricular block. The atrial pacing burden in patients with SND remained above 60% within the 5 years of follow-up investigated. There was no significant difference in mortality between those patients requiring a PPM and those not (Log-Rank test: P = 0.672). We found that in our cohort donor characteristics were key risk factors for pacemaker implantation in transplanted children. The data suggest that when patients require a pacemaker in posttransplant SND, they will require a relevant amount of pacing for at least 5 years. The pacing burden after this point remains to be investigated. Mortality does not differ between pediatric heart transplant patients with and without pacemakers.

Incidence, indications and predicting factors of permanent pacemaker implantation after transcatheter aortic valve implantation: A retrospective study

As the number of transcatheter aortic valve implantation (TAVI) procedures is constantly increasing, it is important to consider common complications, such as pacemaker (PM) implantation, and their specific risk factors. Echocardiographic, computed tomography and electrocardiographic data were analysed to determine the predicting factors, if any, associated with PM implantation. This retrospective study included patients referred to Nancy University Hospital for a TAVI procedure from January 2013 to December 2015. Both Medtronic CoreValve and Edwards SAPIEN valves were implanted. Patients with preprocedurally implanted PMs and/or referred from another institution were excluded. Of 208 TAVI patients, 23 had a pre-existing PM and were excluded. A new PM was required in 38 patients (20.5%). Pre-existing right bundle branch block (RBBB), the use of the Medtronic CoreValve and large prostheses were identified as predictors of PM implantation (P=0.0361, P=0.0004 and P=0.0019, respectively). Using logistic regression, predictors of PM implantation included first-degree atrioventricular block (odds ratio 3.7, 95% confidence interval 1.5-9.1; P=0.0054) and large aortic annulus diameter in echocardiography (odds ratio 1.2, 95% confidence interval 1-1.4; P=0.0447), with a threshold of 24.1mm. For the combination of preTAVI PR duration >220ms and QRS duration >120ms, the positive predictive value for PM implantation reached 80%. Use of the Medtronic CoreValve, RBBB and first-degree atrioventricular block are major risk factors for post-TAVI PM implantation. In addition, large aortic annulus and large valvular prosthesis are independent risk factors for PM implantation. The combination of preTAVI prolonged PR interval and increased QRS duration could be used as a marker for periprocedural PM implantation.

The influence of native aortic valve calcium and transcatheter valve oversize on the need for pacemaker implantation after transcatheter aortic valve insertion

ObjectiveNative aortic valve calcium and transcatheter aortic valve oversize have been reported to predict pacemaker implantation after transcatheter aortic valve insertion. We reviewed our experience to better understand the association. MethodsWe retrospectively reviewed the records of 300 patients with no prior permanent pacemaker implantation who underwent transcatheter aortic valve insertion from November 2008 to February 2015. Valve oversize was calculated using area. The end point of the study was 30-day postoperative pacemaker implantation. ResultsPatient data included age of 81.1 ± 8.4 years, female sex in 135 patients (45%), atrial fibrillation in 74 patients (24.7%), Society of Thoracic Surgeons predicted risk of mortality of 7.6% (interquartile range [IQR], 5.3-10.6), aortic valve calcium score of 2568 (IQR, 1775-3526) Agatston units, and annulus area of 471 ± 82 mm2. Balloon-expandable valves were inserted in 244 patients (81.3%). Transcatheter aortic valve oversize was 12.8% (IQR, 3.9-23.3). Pacemaker implantation was performed in 59 patients (19.7%). Aortic valve calcium score (adjusted P = .275) and transcatheter valve oversize (adjusted P = .833) were not independent risk factors for pacemaker implantation when controlling for preoperative right bundle branch block (adjusted odds ratio, 3.49; 95% confidence interval, 1.61-8.55; P = .002), implantation of self-expanding valve (adjusted odds ratio, 4.09; 95% confidence interval, 1.53-10.96; P = .005), left bundle branch block (adjusted P = .331), previous percutaneous coronary intervention (adjusted P = .053), or valve surgery (adjusted P = .111), and PR interval (adjusted P = .350). ConclusionsRight bundle branch block and implantation of a self-expanding prosthesis were predictive of pacemaker implantation, but not native aortic valve score or transcatheter valve oversize.

Incidence and risk factors for pacemaker implantation following aortic valve replacement

Our aim was to identify the predictive factors for permanent pacemaker (PM) implantation in patients undergoing isolated aortic valve replacement (AVR). A total of 3534 patients received an AVR between January 1990 and December 2003 in our institution. Permanent PM implantation was performed in 234 (6.6%) patients, over median time of three days (range one to 24days). This patient population was compared to a random sample of 191 patients undergoing AVR without permanent PM implantation. The overall mean age was 63.5years (±14.2) and 261 patients (62%) were male. Univariate and multivariate logistic regression analysis of pre- and perioperative data were performed. Overall the 30days mortality was 4.2% (10/234) in patients with PM and 1% (2/191) in the control group (P=0.046). Patients with PMs were older (P<0.001), had more additional coronary artery bypass grafting (CABG) surgery or mitral valve replacement (MVR) (P<0.001), complete right bundle branch block (RBBB) prior to surgery, and more frequently underwent re-operations compared to patients without PMs (P<0.001). The multivariate logistic regression model with PM implantation as the dependent variable demonstrated that older age was not independently associated with PM implantation. As independent predictors concomitant severe mitral valve insufficiency, CABG, subaortic stenosis (SAS) or re-do operations were identified.