Conduction system disease management in patients candidate and/or treated for the aortic valve disease: an Italian Survey promoted by Italian Association of Arrhythmology and Cardiac Pacing (AIAC).

BACKGROUND: Conduction system disorders represent a frequent complication in patients undergoing surgical (surgical aortic valve replacement, SAVR) or percutaneous (transcatheter aortic valve implantation, TAVI) aortic valve replacement. The purpose of this survey was to evaluate experienced operators approach in this clinical condition. METHODS: This survey was independently conducted by the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) and it consisted of 24 questions regarding the respondents' profile, the characteristics of participating centres, and conduction disease management in different scenarios. RESULTS: Fifty-five physicians from 55 Italian arrhythmia centres took part in the survey. Prophylactic pacemaker implantation is rare. In case of persistent complete atrioventricular block (AVB), 49% and 73% respondents wait less than one week before implanting a definitive pacemaker after SAVR and TAVI, respectively. In case of second degree AVB, the respondents wait some days more for definitive implantation. Respondents consider bundle branch blocks, in particular pre-existing left bundle branch block (LBBB), the worst prognostic factors for pacemaker implantation after TAVI. The implanted valve type is considered a relevant element to evaluate. In patients with new-onset LBBB and severe/moderate left ventricular systolic dysfunction, respondents would implant a biventricular pacemaker in 100/55% of cases, respectively. CONCLUSIONS: Waiting time before a definitive pacemaker implantation after aortic valve replacement has reduced compared to the past, and it is anticipated in TAVI vs. SAVR. Bundle branch blocks are considered the worse prognostic factor for pacemaker implantation after TAVI. The type of pacemaker implanted in new-onset LBBB patients without severe left ventricular systolic dysfunction is heterogeneous.

Recent improvement in operative techniques lead to lower pacemaker rate after Perceval implant.

OBJECTIVES: Our goal was to compare pacemaker rate usage following two different operating techniques for implanting the Perceval aortic valve replacement. METHODS: In this retrospective, single-centre study, we studied patients with isolated or concomitant Perceval aortic valve replacement operated on first between April 2013 and January 2016, following traditional operating techniques, with patients operated on between January 2016 and December 2020, after the adoption of a modified protocol based on different annulus sizing, higher positioning of the valve and no ballooning after valve deployment was adopted. The operations were performed by 2 surgeons, and patients were followed-up for a period of 30 days. RESULTS: A total of 286 patients, with a mean age of 77 (4.9) years, had Perceval valves implanted during the study period, of which 79% were isolated aortic valve procedures. Most patients (66.8%) underwent minimally invasive procedures. Cross-clamp time was 55.1 (17.6) min. The overall postoperative pacemaker insertion rate was 8.4%, which decreased decisively after the 2016 change in the implant protocol (16% vs 5.6%; P = 0.005), adjusted odds ratio of 0.31 (95% confidence interval: 0.13-0.74, P = 0.012). Univariable and multivariable analysis showed that larger valve size (P = 0.01) and ballooning (P = 0.002) were associated with higher risk of implanting a pacemaker. Postoperative 30-day mortality was of 4.5%. CONCLUSIONS: Improvement in the operating techniques for implanting the Perceval valve may decrease the rate of pacemakers implanted postoperatively. Although further studies are needed to confirm these results, such a risk reduction may lead to wider use of Perceval valves in the future, potentially benefiting patients who are suitable candidates for minimally invasive surgery.

Procedural Results of Patients Undergoing Transcatheter Aortic Valve Implantation With Aortic Annuli Diameter ≥26 mm: insights from the German Aortic Valve Registry.

Patients presenting with severe aortic stenosis and large aortic annuli are challenging to treat because of the size limitations of available transcatheter heart valves. In this study, we aimed to determine clinical and hemodynamic outcomes in patients presenting with large aortic annuli who underwent transcatheter aortic valve implantation (TAVI). Patients from the German Aortic Valve Registry who underwent TAVI either with the Edwards Sapien (ES) or Medtronic CoreValve (MCV) systems from 2011 to 2017 were included. They were further stratified into a large (aortic annulus diameter 26 to 29 mm for ES; 26 to 30 mm for MCV) and extra-large (aortic annulus diameter >29 mm for ES; >30 mm for MCV) group and analyzed using propensity score adjustment. Extra-large was set beyond the sizing limitations according to the manufacturer's instructions for use. Patients in the large (n = 5,628) and extra-large (n = 509) groups were predominantly male (large: 92.6% vs extra-large: 91.9%). The 30-day mortality was comparable (large: 3.9% vs extra-large: 5.0%, p = 0.458). Procedure duration (large: 78.9 minutes ± 0.82 vs extra-large: 86.4 minutes ± 1.9, p <0.001) was longer in the extra-large group. Likewise, vascular complications (large: 6.2% vs extra-large: 12%, p = 0.002) and the need for a permanent pacemaker implantation (large: 18.8% vs extra-large: 26.0%, p = 0.027) were more often present in the extra-large group. Aortic regurgitation ≥II after valve implantation was numerically higher (large: 3.0% vs extra-large: 5.3%, p = 0.082) in patients with extra-large anatomy. In conclusion, patients with large and extra-large aortic annulus diameters who underwent TAVI have comparable 30-day mortality. Beyond the recommended annulus range, there is a higher risk for vascular complications and permanent pacemaker implantation.

Outcomes of supraventricular tachycardia ablation: Results from the Singapore ablation and cardiac devices registry.

BACKGROUND: The Singapore Cardiac Databank was designed to monitor the performance and outcomes of catheter ablation. We investigated the outcomes of paroxysmal supraventricular tachycardia (PSVT)-ablation in a prospective, nationwide, cohort study. METHODS: Atrioventricular nodal re-entrant tachycardia (AVNRT), atrioventricular re-entry tachycardia (AVRT), or atrial tachycardia (AT)-ablations in Singapore from 2010 to 2018 were studied. Outcomes include acute success, periprocedural-complications, postoperative pacing requirement, arrhythmic recurrence and 1-year all-cause mortality. RESULTS: Among 2260 patients (mean age 45 ± 18 years, 50% female, 57% AVNRT, 37% AVRT, 6% AT), overall acute success rates of PSVT-ablation was 98.4% and increased in order of AT, AVRT, and AVNRT (p < .001). Periprocedural cardiac tamponade occurred in two AVRT patients. A total of 15 pacemakers (6 within first 30-days, 9 after 30-days) were implanted (seven AV block, eight sinus node dysfunction [SND]), with the highest incidence of pacemaker implantation after AT-ablation (5% vs. 0.6% AVNRT vs. 0.1% AVRT, p < .001). Repeat ablations (0.9% AVNRT, 7% AVRT, 4% AT, p < .001) were performed in 78 (3.5%) patients and 13 (0.6%) patients died within a year of ablation. Among outcomes considered adjusting for age, sex, PSVT-type and procedure-time, AT was independently associated with 6-fold increased odds of total (adjusted odds ratio [AOR] 6.32, 95% confidence interval [CI] 1.95-20.53) and late (AOR 6.38, 95% CI 1.39-29.29) pacemaker implantation, while AVRT was associated with higher arrhythmic recurrence with repeat ablations (AOR 4.72, 95% CI 2.36-9.44) compared to AVNRT. CONCLUSIONS: Contemporary PSVT ablation is safe with high acute success rates. Long-term outcomes differed by nature of the PSVT.

Effect of Radiolucent Line-Guided Balloon-Expandable Transcatheter Aortic Valve Implantation on Subsequent Pacemaker Rate.

In the era of expanding transcatheter aortic valve implantation (TAVI) indications for low surgical risk patients, conduction disturbances requiring permanent pacemaker implantation (PPI) after TAVI remain a serious concern. We aimed to assess the impact of the radiolucent line-guided technique for the SAPIEN 3 implantation on reducing the rates of new-onset PPI after TAVI. A total of 326 patients treated with the SAPIEN 3 using either the radiolucent line-guided technique (lucent group, 170 patients [52.1%]) or the center marker-guided technique (conventional group, 156 patients [47.9%]) were prospectively included in our database. The prosthesis position, and 30-day and 3-year clinical outcomes were retrospectively assessed. Compared with the conventional group, the lucent group had a higher prosthesis position (1.7 ± 0.9 mm vs 4.2±1.5 mm, p <0.001) and lower 30-day PPI rates (2.9% vs 13.5%, p <0.001). The other periprocedural complications including valve dislodgement and coronary obstruction, and 30-day and 3-year mortality were comparable between the groups. However, the prosthesis frame extending above sinotubular junction was more frequently observed in the lucent group on the side of left coronary sinus (53.4% vs 31.4%, p <0.001) and right coronary sinus (35.0% vs 20.2%, p = 0.001), signifying a potential risk for "subsequent difficulties to access coronary ostia" and "coronary obstruction during future redo TAVI." In conclusion, the radiolucent line-guided technique predictably provided an extremely high position of the SAPIEN 3, reducing the postprocedural PPI rates compared with the center marker-guided technique.

Patient with sick sinus syndrome and implanted dual-chamber pacemaker with reduced P-wave duration following low interatrial septal pacing: Case report.

INTRODUCTION: A dual-chamber pacemaker (DDD/R) for a sinus node disease is sometimes referred to as a physiological pacemaker as it maintains atrioventricular synchrony, however several clinical trials have proved its inferiority to a nonphysiological single-chamber ventricular back-up pacing. PATIENT CONCERNS: A subject of the study is a 74-year-old woman with a sick sinus syndrome (SSS) and a previously implanted physiological DDD/R pacemaker. The SSS was diagnosed because of patient's very slow sinus rhythm of about 36 bpm, and due to several episodes of dizziness. After the DDD/R implantation the percentage of atrial pacing approached 100%, with almost none ventricular pacing. DIAGNOSES: Sick sinus syndrome, complete Bachmann's bundle block, atrial fibrillation, atrial flutter. INTERVENTIONS: The patient was previously implanted with a physiological DDD/R pacemaker. Several years after the implantation, the atrial fibrillation was diagnosed and the pulmonary vein isolation was then performed by cryoablation. During the follow-up after pulmonary vein isolation, the improvement of mitral filling parameters was assessed using echocardiography. Shortly thereafter the patient developed the persistent paroxysm of a typical atrial flutter which was successfully terminated using a radiofrequency ablation. No recurrence thereof has been observed ever since (24 months). OUTCOMES: The atrial electrode of the pacing system was implanted within the low interatrial septal region that resulted in a reduced P-wave duration compared to native sinus rhythm P-waves. The said morphology was deformed because of the complete Bachmann bundle block. That approach, despite a nonphysiological direction of an atrial activation, yielded relatively short P-waves (paced P-wave: 179 ms vs intrinsic sinus P-wave: 237 ms). It also contributed to a significantly shorter PR interval (paced PR: 204 ms vs sinus rhythm PR: 254 ms). CONCLUSIONS: The authors took into consideration different aspects of alternative right atrial pacing sites. This report has shown that in some patients with a sinus node disease, low interatrial septal pacing can reduce the P-wave duration but does not prevent from the development of atrial arrhythmias.

Long-term prognosis of patients with permanent cardiac pacemaker indication in three referral cardiac centers in Cameroon: Insights from the National pacemaker registry.

BACKGROUND: There is evidence that cardiac pacemakers improve symptoms and quality of life in patients with severe bradycardia. Globally, the number of pacemaker implantations is on the rise. However, the associated high-cost limits pacemaker's accessibility in low resource settings. This study aimed to investigate access to pacemakers and the long-term outcome of patients requiring a pacemaker. METHOD: We conducted a cohort study in 03 health care structures in Cameroon. Participants aged at least 18 years with indication for a permanent pacemaker between January 2010 and May 2016 were included. Clinical profile, electrocardiography, pacemaker implantation parameters were recorded. Long-term survival was studied by event-free analysis using the Kaplan-Meier method. RESULTS: In total, 147 participants (mean age 67.7±13.7 years, female 58.5%) were included. Fatigue (78.7%), dyspnoea (77.2%), dizziness (47.1%) and palpitations (40.4%) were the main symptoms while syncope was present in 35.7% of patients. The main indication for cardiac pacemaker was atrioventricular block (85.3%). Forty (27.2%) could not be implanted with 34 (85%) of participants highlighting cost of intervention as main reason. VVIR was the main mode of stimulation (70.5%). Of 125 patients in which follow-up was ascertained, 17(13.5%) died after a median survival time of 2.8 years post diagnosis [IQR: 1.8-4.2]. The survival curve was better in participants with a pacemaker with a Hazard ratio of 2.7 [CI: 1.0-7.3, P=0.045]. CONCLUSION: Our patients with severe heart blocks presented late and more than a quarter did not have access to pacemaker but its implantation multiplied the survival rate by 2.7 times at approximately 3 years post diagnosis. Improving early detection of heart blocks and access to cardiac pacing to reduce mortality shall be a key future priority.

In-Hospital Outcomes in Patients With a History of Malignancy Undergoing Transcatheter Aortic Valve Implantation.

A history of malignancy is incorporated in the Society of Thoracic Surgeons score to assess presurgical risk in patients undergoing surgical aortic valve replacement, however data on the prognostic importance in those undergoing transcatheter aortic valve implantation (TAVI) remains limited. We sought to investigate the utilization and in-hospital outcomes of TAVI in patients with a history of malignancy. The National Inpatient Sample Database was queried from 2012 to 2017 to identify patients who underwent TAVI using International Classification of Diseases (ICD) 9 and ICD-10 procedure codes. Between 2012 and 2017, there were 123,070 patients who underwent TAVI, of these 23,670 patients (19.2%) had a previous history of malignancy. The proportion of patients undergoing TAVI with a history of malignancy trended upward between 2012 and 2017. Patients with a history of malignancy were similar in age to those without (81.1 ± 7.9 vs 80.1 ± 6.7 years old, p <0.001), with a higher prevalence of tobacco use and major depressive disorder (p <0.001 for both). Patients with a history of malignancy had higher rates of post-TAVI pacemaker implantation (p <0.001), otherwise periprocedural complication rates were similar to those without. Using a multivariate logistic regression model to adjust for confounding factors, a history of malignancy was predictive of decreased odds of death in patients underwent TAVI (OR: 0.67, 95% CI, 0.60 to 0.76, p <0.001) and higher odds of pacemaker implantation (OR: 1.14, 95% CI, 1.09 to 1.19, p <0.001). In conclusion, with time the proportion of TAVI patients with a history of malignancy trended upward. Despite a greater prevalence of previous tobacco use and major depressive disorder, patients with a history of malignancy had TAVI safely with a low in-hospital all-cause mortality, yet greater cost of hospitalization and more frequent implantation of pacemaker devices.

Determinants of In-Hospital Death Among the Very Elderly with Acute Myocardial Infarction.

Since the number of elderly patients suffering from acute myocardial infarction (AMI) has been increasing in developed countries, primary percutaneous coronary intervention (PCI) for the very elderly aged ≥80 years old is already common. The study aimed to examine the determinants of in-hospital death among the very elderly with AMI in current PCI era. We included 412 consecutive AMI patients aged ≥ 80 years old who received PCI to the culprit lesion; however, 42 patients (10.2%) died during the index hospitalization. Thus, univariate and multivariate logistic regression analyses were performed to identify the determinants of in-hospital death. Of note, the modified KATZ index, which is a seven-point scale ranging from 0 to 6 (0 point indicating no dependence and six points indicating full dependence), was calculated to evaluate pre-admission activity of daily living (ADL). In multivariate analysis, cardiac arrest (OR 4.642, 95% CI 1.177-18.305, P = 0.028), Killip class IV (versus Killip class I: OR 5.732, 95% CI 1.076-16.630, P = 0.001), modified KATZ index (OR 1.212, 95% CI 1.001-1.469, P = 0.049), hemoglobin levels (OR 0.803, 95% CI 0.656-0.983, P = 0.033), use of temporary pacemaker (OR 2.603, 95% CI 1.010-6.709, P = 0.048), final Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 (versus TIMI ≤ 2: OR 0.240, 95% CI 0.093-0.618, P = 0.003), and mechanical circulatory support (OR 4.264, 95% CI 1.818-10.005, P = 0.001) were found to be significantly associated with in-hospital death. In conclusion, in-hospital outcomes of the very elderly with AMI were still poor in the current PCI era. Poor pre-admission ADL as well as cardiogenic shock and anemia were determined to be strongly associated with in-hospital death.

"Preventive" pacing in patients with tachy-brady syndrome (TBS): Confirming a common practice.

AIMS: Many tachy-brady syndrome (TBS) patients, are implanted a permanent pacemaker (PPM) to allow continuation of anti-arrhythmic drug (AAD) therapy to maintain sinus rhythm. Many of these PPM's are implanted as a preventive measure, in absence of symptomatic bradycardia. Our primary aim was to evaluate pacing use among these patients and find predictors for PPM use. Our secondary aim was to appreciate the portion of these patients who progress to permanent atrial fibrillation (AF). METHODS: Retrospective study of TBS patients implanted a PPM as preventive measure, dividing cases into defined categories regarding highest percent atrial and ventricular pacing documented in PPM clinic visits during 3 year follow-up (F/U) period. Patients' baseline characteristics and AAD therapy were compared between cases with a major (>90%) pacing use and cases with <90% pacing use to find predictors for pacing use. Multivariable logistic regression was applied to identify independent variables associated with major pacing use. RESULTS: Our study included 119 TBS patients. Most (86.5%) TBS patients had a moderate (>50%) pacing use and 58% had a major pacing use. Significant association was found between pre-implant severe sinus bradycardia (<40 bpm), first degree atrioventricular block and amiodarone treatment to major pacing use on univariate analysis and severe sinus bradycardia was significantly associated with major pacing on multivariate analysis as well. Only minority (16.8%) of TBS patients progressed to permanent AF during the study F/U period. CONCLUSION: Our study reveals most TBS patients succeed to maintain sinus rhythm using an AAD with a significant pacing use, suggesting preventive PPM implantation might be advantageous in these cases. Pre-implant severe sinus bradycardia (<40 bpm) is a possible predictor for major pacing use in this population.

Meta-analysis Comparing Outcomes of Self-Expanding Versus Balloon-Expandable Valves for Transcatheter Aortic Valve Implantation.

There are two commercially available transcatheter heart valve systems: balloon expandable valves (BEV) and self-expanding valves (SEV). However, there is a paucity of randomized trials comparing both systems. Electronic databases (Medline, the Cochrane Library, Web of Science, and clinicaltrials.gov) and major conference proceedings were searched for randomized trials of patients with symptomatic severe aortic stenosis and received transcatheter aortic valve implantation (TAVI) with a SEV or BEV or surgical aortic valve replacement. The main efficacy outcomes were all-cause mortality and stroke at the longest available follow-up. The main analysis was performed using a random-effects network meta-analysis complemented by several subgroup and sensitivity analyses. Ten trials with 9,439 patients (mostly undergoing transfemoral TAVI) were included. At a median of 27 months, there was no difference between BEV and SEV valves in terms of all-cause mortality (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.79 to 1.42). The incidence of any stroke was higher with BEV (OR 1.51, 95% CI 1.01 to 2.26), but there was no difference in the incidence of disabling stroke. At 30-days, BEV valves were associated with lower incidence of new permanent pacemaker placement (OR 0.50, 95% CI 0.32 to 0.79) and moderate/severe paravalvular regurgitation (OR 0.39, 95% CI 0.22 to 0.68). In conclusion, in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI, SEV and BEV were associated with similar all-cause mortality. BEV were associated with a higher incidence of any stroke driven by nondisabling strokes, but lower incidence of new permanent pacemaker placement and moderate/severe paravalvular regurgitation compared with SEV.

Arrhythmias in Relation to Mortality After Transcatheter Aortic Valve Replacement.

BACKGROUND: The purpose of this study was to identify predictors of mortality and potentially modifiable factors related to arrhythmias in patients that undergo transcatheter aortic valve replacement (TAVR). Patients that undergo TAVR are at risk for complete heart block requiring pacemaker implant. Additionally, other arrhythmias, specifically atrial fibrillation (AF), are common in this population. It is unclear how arrhythmias and their management contribute to mortality risk. METHODS: The study analyzed 176 patients who underwent TAVR at a single center. Factors associated with pacemaker implantation within 30 days were analyzed by logistic regression. Factors associated with mortality were analyzed by Kaplan-Meier and Cox regression analyses. RESULTS: Mean age was 80 ± 8.5 years. AF was present in 69 patients, and 39 received anticoagulation. Post-TAVR, a pacemaker was implanted in 25 patients within 30 days. Over a follow up of 566 ± 496 days, 49 patients died. In multivariable analysis, right bundle branch block remained significant (odds ratio 4.212, P = 0.012) for pacemaker implant within 30 days. The AF (hazard ratio [HR] 3.905, P = 0.001), albumin level (HR 0.316, P = 0.034), and diabetes (HR 2.323, P = 0.027) were predictors of death in a multivariate analysis, while pacemaker implant within 30 days was not. Patients with AF who were anticoagulated had improved survival in a stratified Kaplan-Meier analysis compared with those who were not anticoagulated (P = 0.0001). CONCLUSION: AF, diabetes, and low albumin levels are independently associated with mortality after TAVR. In particular, patients with AF who are not anticoagulated are at highest risk for death. Efforts to identify AF and consider anticoagulation should be emphasized.

Risk Prediction Model for Cardiac Implantable Electronic Device Implantation After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to develop and validate a risk prediction model for high-grade atrioventricular block requiring cardiac implantable electronic device (CIED) implantation after transcatheter aortic valve replacement (TAVR). BACKGROUND: High-grade atrioventricular block requiring CIED remains a significant sequelae following TAVR. Although several pre-operative characteristics have been associated with the risk of post-operative CIED implantation, an accurate and validated risk prediction model is not established yet. METHODS: This was a single center, retrospective study of consecutive patients who underwent TAVR from March 10, 2011, to October 8, 2018. This cohort sample was randomly divided into a derivation cohort (group A) and a validation cohort (group B). A scoring system for risk prediction of post-TAVR CIED implantation was devised using logistic regression estimates in group A and the calibration and validation were done in group B. RESULTS: A total of 1,071 patients underwent TAVR during the study period. After excluding pre-existing CIED, a total of 888 cases were analyzed (group A: 507 and group B: 381). Independent predictive variables were as follows: self-expanding valve (1 point), hypertension (1 point), pre-existing first-degree atrioventricular block (1 point), and right bundle branch block (2 points). The resulting score was calculated from the total points. The internal validation in group B showed an ideal linear relationship in calibration plot (R2 = 0.933) and a good predictive accuracy (area under the curve: 0.693; 95% confidence interval: 0.627 to 0.759). CONCLUSIONS: This prediction model accurately predicts post-operative risk of CIED implantation with simple pre-operative parameters.

Outcomes of Standard Permanent Active Fixation Leads for Temporary Pacing.

OBJECTIVES: This study investigated the performance of Temporary Pacing via an Externalized Active-Fixation (TPEAF) lead. BACKGROUND: The incidence of cardiac implantable electronic device infections is increasing, which necessitates the need for transvenous lead extraction (TLE). Pacemaker-dependent patients require temporary pacing during the guideline-recommended waiting period before reimplantation. Data regarding safety and efficacy of TPEAF leads are very limited. METHODS: We evaluated patients implanted with TPEAF leads post-TLE at our center between April 2004 and December 2017. RESULTS: TPEAF leads were placed in 158 patients. The mean age was 74 ± 11 years. The median duration of the temporary lead was 6 days (range 1 to 29). There were 4 procedural complications (2.5% incidence): 1 patient had cardiac arrest from hyperkalemia, 2 developed cardiac tamponade, and 1 had profuse bleeding from the entry point of the leads. There were 13 complications post-implantation (8.2% incidence): 8 lead dislodgments, 1 elevated pacing threshold, 2 vegetations on the temporary lead, 1 pneumothorax, and 1 loss of capture due to the generator "safety switch." All dislodgements occurred within 24 h, except 1 on day 3. Sixteen patients died during the hospital stay: 10 due to septic shock, 2 due to hyperkalemic cardiac arrest, 3 due to ventricular tachycardia, and 1 due to a massive cerebrovascular accident. CONCLUSIONS: The use of TPEAF leads is safe and efficacious in pacemaker-dependent patients post-TLE. Dislodgement can occur within the first 24 h. The presence of persistent fever and positive blood cultures should raise concern for vegetation on the temporary lead.

Effect of Ventricular Pacing on Morbidity in Adults After Fontan Repair.

Implantation of a permanent pacemaker is a negative prognostic marker in patients with Fontan palliation; however, data delineating outcomes in adult patients with pacemaker requirements are lacking. We hypothesize that high ventricular pacing burden is associated with adverse outcomes in adult Fontan patients. We performed a retrospective review comprising adult patients with history of Fontan repair. A high burden of ventricular pacing was defined as ≥40% pacing. Major adverse clinical events (MACE) were defined as all-cause mortality or need for advanced cardiac therapies (ventricular assist device or heart transplant). A total of 145 adult patients with Fontan were studied for a median of 3.1 years. Twenty (14%) patients had implanted pacemakers with ≥40% ventricular pacing. Twelve events occurred in those with ≥40% ventricular pacing (incidence 60.0%) versus 11 in those without (incidence 8.8%). In multivariable analysis, ≥40% ventricular-pacing (odds ratio 12.51, confidence interval [CI] 3.56 to 43.83, p <0.001) was associated with MACE independent of initial Fontan type, New York Heart Association functional class at baseline, or history of atrial tachyarrythmia. In survival analysis, patients with ≥40% ventricular pacing had nearly 8 times the risk of MACE compared with those with a lower ventricular pacing burden (hazard ratio 7.79, 95% CI 2.56 to 23.66, p <0.001), whereas patients with atrial-only or <40% ventricular pacing burden had a trend toward higher hazard of MACE compared with those without permanent pacemaker (hazard ratio 3.38, 95% CI 0.92 to 12.47, p = 0.07) that did not meet statistical significance. These findings suggest that high ventricular pacing burden contributes to poor outcomes in the adult Fontan patients and bear consideration when determining optimal treatment of tachyarrhythmias in this population.

Usefulness of Serum Free Thyroxine Concentration to Predict Ventricular Arrhythmia Risk in Euthyroid Patients With Structural Heart Disease.

The aim of the present study was to determine whether free thyroxine (FT4) and calculated thyroid parameters predict the incidence of ventricular arrhythmias in euthyroid heart failure patients with implantable cardioverter-defibrillators (ICD). In this open-label prospective cohort study, 115 consecutive euthyroid patients (mean age 62.9 ± 1.3 years; 87% male; ischemic cardiomyopathy 63%) scheduled for primary prevention ICD implantation or exchange were enrolled. Serum concentrations of thyrotropin (thyroid-stimulating hormone) and FT4 were measured 1 day before device operation. Primary and secondary end points were defined as occurrence of appropriate ICD therapy (AIT) and cardiovascular death, respectively. During a mean follow-up of 1,191 ± 35 days, 24 patients (21%) experienced AIT, and cardiovascular death was observed in 10 patients (9%). Patients with AIT had higher FT4 concentrations compared with those without AIT (18.9 ± 0.48 vs 16.2 ± 0.22 pmol/L, p <0.001). FT4 was an independent predictor of AIT in an adjusted Cox regression (hazard ratio = 1.47, p <0.001). Kaplan-Meier analysis demonstrated that Jostel's thyroid-stimulating hormone index, reflecting the central component of the hypothalamus-pituitary-thyroid loop, and SPINA-GT as surrogate markers for thyroid's secretory capacity predicted AIT incidences. None of the indices predicted cardiovascular death. In conclusion, FT4 concentration predicts an increased incidence of ventricular arrhythmias in euthyroid patients receiving ICDs for primary prevention. Our data suggest that both impending primary hyperthyroidism and an increased thyroid homeostasis set point may increase the rate of AIT in this patient population.

Transcatheter aortic valve implantation in nonagenarians: insights from the German Aortic Valve Registry (GARY).

OBJECTIVE: The aim of this study was to compare the outcome of nonagenarians (≥ 90 years) with that of younger (< 90 years) patients undergoing transcatheter aortic valve implantation (TAVI) in current practice. METHODS: Data are collected from the German Aortic Valve Registry (GARY), which was designed to evaluate current practice in the invasive treatment of patients with aortic valve diseases in Germany. Data were analyzed regarding procedural outcome, 30-day, and 1-year outcomes of nonagenarians in comparison to that of younger patients. RESULTS: Between 2011 and 2015, 2436/33,051 (7.3%) nonagenarians underwent TAVI and were included in GARY. Nonagenarians were significantly more often male (45.2% vs. 40.0%, p < 0.001), frail (38.7% vs. 34.7%, p < 0.001), and had higher EuroSCORE scores than younger patient group (23.2% vs. 17.0%). Nonagenarians were significantly less often treated via transapical access (16.3% vs. 22.3%, p < 0.001). Procedure was performed significantly less often in general anesthesia (58.2% vs. 60.7%, p = 0.02) in nonagenarians, while necessity of pacemaker implantation was significantly higher in nonagenarians (27.2% vs. 24.8%, p > 0.001). The incidence of other typical postprocedural complications such as severe bleeding events and vascular complications were comparable between groups. However, 30-day (5.2% vs. 3.9%) and 1-year (22.7% vs. 17.7%) mortality rates were significantly higher among nonagenarians and age ≥ 90 years could be identified as an isolated risk factor for mortality. CONCLUSION: TAVI is a highly standardized procedure that can be performed safely with high procedural success even in very old patients. Although mortality is significantly higher in these patients-most probably due to the intrinsic higher risk profile of the very old patients-the results are still acceptable. To optimize outcome, especially elderly patients seem to profit from a procedure under local anesthesia or conscious sedation, to minimize the rate of postoperative delirium and the length of stay and to facilitate early mobilization.