Need For Pacemaker Implantation Research Articles

Comparative Analysis of PCI Strategies in Aortic Stenosis Patients Undergoing TAVI: A Systematic Review and Network Meta-Analysis.

Transcatheter aortic valve implantation (TAVI) has been increasingly used in patients with severe aortic stenosis (AS). Since coronary artery disease (CAD) is common among these patients, it is crucial to choose the best method and timing of revascularization. This study aims to compare different timing strategies of percutaneous coronary intervention (PCI) in patients with severe AS undergoing TAVI to clarify whether PCI timing affects the patients' outcomes or not. A frequentist network meta-analysis was conducted comparing three different revascularization strategies in patients with CAD undergoing TAVI. The 30-day all-cause mortality, in-hospital mortality, all-cause mortality at 1 year, 30-day rates of myocardial infarction (MI), stroke, and major bleeding, and the need for pacemaker implantation at 6 months were analyzed in this study. Our meta-analysis revealed that PCI during TAVI had higher 30-day mortality (RR = 2.46, 95% CI = 1.40-4.32) and in-hospital mortality (RR = 1.70, 95% CI = [1.08-2.69]) compared to no PCI. Post-TAVI PCI was associated with higher 1-year mortality compared to other strategies. While no significant differences in major bleeding or stroke were observed, PCI during TAVI versus no PCI (RR = 3.63, 95% CI = 1.27-10.43) showed a higher rate of 30-day MI. Our findings suggest that among patients with severe AS and CAD undergoing TAVI, PCI concomitantly with TAVI seems to be associated with worse 30-day outcomes compared with no PCI. PCI after TAVI demonstrated an increased risk of 1-year mortality compared to alternative strategies. Choosing a timing strategy should be individualized based on patient characteristics and procedural considerations.

Relationship between membranous septum length and need for pacemaker implantation after transcatheter aortic valve implantation

Relationship between membranous septum length and need for pacemaker implantation after transcatheter aortic valve implantation

Mean compression ratio of a self-expandable valve is associated with the need for pacemaker implantation after transcatheter aortic valve replacement

BackgroundThe risk and timing of permanent pacemaker implantation (PPMI) after transcatheter aortic valve replacement (TAVR) is still hard to predict. We aimed to analyze the relationship between the compression ratio of a self-expandable valve (SEV) and the need for PPMI after TAVR.MethodsA total of 106 patients who were implanted with the VitaFlow transcatheter aortic valve system and for whom complete imaging information was available were included in this retrospective cohort study. Eight lines perpendicular to the long axis of the SEV were drawn (the top and bottom of the SEV and the intersection of each row of wires) for measurement purposes. The compression ratio was calculated as 1 − (in vivo meridian/in vitro meridian) and compared between patients undergoing and those not undergoing PPMI after adjusting for implantation depth. Multivariable logistic regression and Cox proportional hazards models were used to assess factors associated with the risk and timing of the need for PPMI.ResultsFifteen (14.2%) patients underwent PPMI after TAVR. Patients with a higher mean compression ratio (20%, odds ratio [OR] = 214.82; p < 0.001) and prior right bundle branch block (OR = 51.77; p = 0.015) had a higher risk of the need for PPMI after TAVR. These two factors were also associated with the timing of PPMI, according to the Cox proportional hazards model.ConclusionsThe compression ratio of the SEV was positively associated with the risk of PPMI after TAVR, and the association was most significant in the annular and supravalvular planes. The compression ratio may also affect the time to PPMI.

Long-term outcomes of cardioneuroablation with and without extra-cardiac vagal stimulation confirmation in severe cardioinhibitory neurocardiogenic syncope.

Cardioneuroablation (CNA) is a novel therapeutic approach for functional bradyarrhythmias, specifically neurocardiogenic syncope or atrial fibrillation, achieved through endocardial radiofrequency catheter ablation of vagal innervation, obviating the need for pacemaker implantation. Originating in the nineties, the first series of CNA procedures was published in 2005. Extra-cardiac vagal stimulation (ECVS) is employed as a direct method for stepwise denervation control during CNA. This study aimed to compare the long-term follow-up outcomes of patients with severe cardioinhibitory syncope undergoing CNA with and without denervation confirmation via ECVS. A cohort of 48 patients, predominantly female (56.3%), suffering from recurrent syncope (5.1 ± 2.5 episodes annually) that remained unresponsive to clinical and pharmacological interventions, underwent CNA, divided into two groups: ECVS and NoECVS, consisting of 34 and 14 cases, respectively. ECVS procedures were conducted with and without atrial pacing. Demographic characteristics, left atrial size, and ejection fraction displayed no statistically significant differences between the groups. Follow-up duration was comparable, with 29.1 ± 15 months for the ECVS group and 31.9 ± 20 months for the NoECVS group (p = .24). Notably, syncope recurrence was significantly lower in the ECVS group (two cases vs. four cases, Log Rank p = .04). Moreover, the Hazard ratio revealed a fivefold higher risk of syncope recurrence in the NoECVS group. This study demonstrates that concluding CNA with denervation confirmation via ECVS yields a higher success rate and a substantially reduced risk of syncope recurrence compared to procedures without ECVS confirmation.

OP147 Measuring Health Technology Assessment Impact On The Introduction Of Transcatheter Aortic Valve Replacement In A Private Healthcare System

IntroductionAortic stenosis is an insidious disease that has a high mortality rate when it becomes symptomatic. Surgical valve replacement is the treatment of choice and has predictable risks. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to surgery, which is indicated for high-risk patients.Complications after TAVR include paravalvular leak, cerebrovascular events, and the need for pacemaker implantation. A health technology assessment report carried out by the Health Technology Assessment Unimed-BH group in 2018, two years before it became part of the National Supplementary Health Agency, recommended the introduction of TAVR with the following criteria: indications provided by a group of specialists; forwarding of a report with detailed clinical data; results of imaging exams; and follow-up results for up to one year after the procedure. After the introduction of TAVR with the agreed criteria, it was possible to access TAVR results from the private healthcare system of Unimed-BH.MethodsAdministrative data were collected from the Unimed-BH database. All patients who received a TAVR implant from 2013 to 2017 were included by virtue of a court injunction, and after 2018 by operator concession and within agreed criteria.ResultsFrom July 2013 to June 2019, 83 patients underwent TAVR implantation by Unimed BH. The median age of patients was 83.4 years (interquartile range 66.5 to 97.9), most of whom were women (56%). There was a predominance of patients in New York Heart Association classification III (50%) and IV (29%). There were 36 patients who underwent TAVR before 2018 and 47 patients within the agreed criteria. In the period prior to the agreed criteria, 28 percent needed a pacemaker, compared with 23 percent after 2018. During the follow-up period, 39 patients died: 18 (50%) before 2018 and 11 (23%) after 2018.ConclusionsThe agreement made with the providers, which included the obligation of having a team of specialists responsible for the indication and access to clinical data through the report, improved patient outcomes. This may be due to having a better indication for the procedure or to the greater experience of the professionals involved in its delivery.

Left ventricular mechanical dispersion as a predictor of the need for pacemaker implantation after transcatheter aortic valve implantation: MeDiPace TAVI study.

Permanent pacemaker (PM) implantation is common after transcatheter aortic valve implantation (TAVI). Left ventricular mechanical dispersion (MeDi) by speckle tracking echocardiography is a marker of fibrosis that causes alterations in the conduction system. We hypothesized that MeDi can be a predictor of the need for PM implantation after TAVI. Consecutively, 200 TAVI patients were enrolled. Transthoracic echocardiography and electrocardiography examinations were recorded before TAVI to evaluate global longitudinal strain (GLS), MeDi, and conduction disturbances. PM implantation information was obtained 3 months after TAVI. Patients were stratified into PM or no PM group. Mean age was 80 + 7 years (44% women). Twenty-nine patients (16%) received PM. MeDi, QRS duration, existence of right bundle branch abnormality (RBBB), and first-degree atrioventricular (AV) block were significantly different between groups. MeDi was 57 ± 15 ms and 48 ± 12 ms in PM and no PM groups, respectively (P < 0.001). In multivariate analysis, MeDi predicted the need for PM after TAVI independently of GLS, QRS duration, RBBB, and first-degree AV block [odds ratio (OR): 1.73, 95% confidence interval (CI): 1.22-2.45] with an area under the curve (AUC) of 0.68 in receiver operating characteristic (ROC) curves. Moreover, RBBB was an independent predictor of PM need after TAVI (OR: 8.98, 95% CI: 1.78-45.03). When added to RBBB, MeDi had an incremental predictive value with an AUC of 0.73 in ROC curves (P = 0.01). MeDi may be used as an echocardiographic functional predictor of the need for PM after TAVI.

Temporal trends, patient characteristics and hospital volume outcomes after alcohol septal ablation and septal myectomy for treatment of obstructive hypertrophic cardiomyopathy

Abstract Background Hypertrophic obstructive cardiomyopathy (HOCM) represents a clinically and morphologically diverse hereditary cardiac disease that is frequently associated with poor prognosis. Nationwide data on septal reduction therapy (SRT), alcohol septal ablation (ASA) and septal myectomy (SM), remains scarce. The aim of this study was to investigate (i) temporal trends, (ii) patient characteristics, (iii) in-hospital outcomes, and associations between institutional procedural volumes and outcomes after ASA and SM in a large-scale nationwide cohort. Methods Using data from the German Federal Bureau of Statistics, this study analyzed all patients with HOCM who were hospitalized for ASA or SM in a nationwide inpatient database in Germany between January 1, 2006, through December 31, 2019. Rates of adverse in-hospital events (in-hospital mortality, need for permanent pacemaker) were examined. Multivariate logistic regression analysis was performed to compare overall outcomes after each procedure based on tertiles of hospital volumes of ASA and SM. Results A total of 8,514 patients underwent SRT, of whom 5,293 (62.2%) underwent ASA and 3,221 (37.8%) SM. Annual numbers for SM and ASA steadily increased over time: ASA procedures increased from 329 in 2006 to 451 in 2019 and SM procedures increased from 191 in 2006 to 222 in 2019, respectively. Patients with SM were older (mean 67.4 vs. 60.2 years), less likely female (56.4% vs. 49.9%), and had a higher burden of comorbidities (e.g., diabetes, atrial fibrillation, heart failure, chronic kidney disease) compared to patients with ASA. Over an observational period of 14 years, the majority of both ASA and SM procedures were performed at hospitals in the lowest volume category (≤20 procedures). The overall in-hospital mortality was higher in patients with SM (6.8%) compared to patients with ASA (0.8%), whereas the need for pacemaker implantation was more often observed in patients with ASA (19.3% vs. 13.1%; p&amp;lt;0.001). The lowest tertile of SM volume among hospitals was independently associated with an increased risk of in-hospital mortality (adjusted odds ratio (lowest vs. highest tertile), 2.64; 95% confidence interval, 1.49-4.66), whereas being in the lowest vs. the highest tertile of ASA by volume was not independently associated with risk of in-hospital mortality and adverse events. Conclusion In this contemporary cohort with more than 8,500 cases of SRT between 2006 and 2019, the majority of SRT was performed at centers with a low volume of SM and ASA procedures. Low SM volume was independently associated with increased in-hospital mortality, whereas low ASA volume was not associated with adverse outcomes. Our findings may help to further understand how institutional SRT procedural volumes affects outcomes and might encourage referral of patients with HOCM to centers of excellence for SRT.

Cardiac morbidity and the cause of death in elderly patients with prostate cancer and incidental cardiac uptake on bone scintigraphy.

Cardiac transthyretin amyloidosis (ATTR) is a possible incidental finding on bone scintigraphy imaged due to prostate cancer. We investigated its significance in 1426 elderly prostate cancer patients (>70 years) who underwent bone scintigraphy in three nuclear medicine departments in Finland. Patients with Perugini grade two or three uptakes were considered positive for cardiac uptake. Heart failure diagnoses and pacemaker implantations were collected from the hospital's records. Mortality data were gathered from the Finnish national statistical service (Statistics Finland). The Median follow-up time was 4 years (interquartile range: 2-5 years). Cardiac uptake was detected in 37 individuals (2.6%), and it was associated with an elevated risk of both overall and cardiovascular death in univariable analysis. However, cardiac uptake did not predict overall mortality in the multivariable analysis when adjusted to age, bone metastases or the diagnosis of heart failure (p > 0.05). The risk of heart failure was higher in patients with cardiac uptake (47% vs. 15%, p < 0.001), while the risk of pacemaker implantations was not elevated (5% vs. 5%, p = 0.89). In conclusion, cardiac uptake on bone scintigraphy imaged due to prostate cancer is associated with an elevated risk of heart failure and both overall and cardiovascular death. However, cardiac uptake was not independently associated with overall mortality when adjusted to age, bone metastasis or heart failure. Therefore, they are essential to consider when incidental cardiac uptake is detected on bone scintigraphy. The need for pacemaker implantation was not elevated in patients with cardiac uptake.

P17 MITRAL ANNULUS CALCIFICATION IN TRANSCATHETER AORTIC VALVE IMPLANTS

Abstract Background Mitral annular calcium (MAC) is a common finding in patients undergoing transcatheter aortic valve implantation (TAVI). However, assessment of MAC in the pre–TAVI diagnostic pathway is not among the procedures routinely performed. Aim of the study In this retrospective study conducted in patients undergoing TAVI, we evaluated (1) the presence and extent of MAC using a multimodal imaging approach; (2) the clinical and structural factors associated with it; and (3) the possible prognostic role of MAC. Methods Between 2016 and 2022, 62 patients with severe aortic stenosis underwent TAVI at the Cardiovascular Department of A.O.U. Careggi (Florence, Italy). Baseline and post–TAVI clinical and echocardiographic data were collected at Santo Stefano Hospital (Prato, Italy). MAC assessment was performed by quantitative analysis on echocardiographic and computed tomography (CT) images, obtaining a MAC severity score. A clinical follow–up was conducted at 30–day intervals in all patients. Results MAC was detected in 48 patients (77%), a severe MAC in 16 patients (26%). CT analysis was more accurate in defining the presence and extent of MAC. Patients with MAC were more female, older in age, with greater cardiovascular risk profile and comorbidities; they presented more frequently mitral valvulopathy and arrhythmias. These differences were amplified by stratifying the population according to MAC severity score. Patients with severe MAC had a pattern of ventricular remodeling with predominantly concentric hypertrophy. Post–TAVI, patients with severe MAC had less hemodynamic benefit and a greater need for pacemaker implantation. A trend of increasing all–cause mortality as MAC score increased was noted. Conclusions Assessment of mitral annular calcium and its extension should become an integral part of the patient‘s pre–TAVI risk stratification process. A phenotypic pattern of concentric left ventricular hypertrophy, mainly associated with patients with severe MAC, identifies a category with lower post procedural recovery.

Sutureless vs. rapid-deployment valve: a systemic review and meta-analysis for a direct comparison of intraoperative performance and clinical outcomes.

Sutureless and rapid-deployment valves are bioprostheses anchoring within the aortic annulus with few sutures, and they act as a hybrid of conventional surgical and transcatheter valves under aortic valve replacement. Considering that the 3F Enable valve is now off-market, the only two sutureless and rapid-deployment valves available on the world marketplace are the Perceval and Intuity valves. However, a direct comparison of the function of these two valves eludes researchers. Against this background, we performed this systematic review and meta-analysis comparing the intraoperative performance and early clinical outcomes between the Perceval valve and the Intuity valve under sutureless and rapid-deployment aortic valve replacement. We systematically searched electronic databases through PubMed/MEDLINE, OvidWeb, Web of Science, and Cochrane Central Register of Controlled Trials (from the establishment of the database to November 17, 2022, without language restriction) for studies comparing the sutureless valve (the Perceval) and the rapid-deployment valve (the Intuity) under aortic valve replacement. Our primary outcomes were early mortality and postoperative transvalvular pressure gradients. The secondary outcomes were defined to include aortic cross-clamp and cardiopulmonary bypass time, paravalvular leak (any paravalvular leak, moderate-to-severe paravalvular leak) after aortic valve replacement, need for pacemaker implantation, postoperative neurological events (stroke), and intensive care unit stay. This meta-analysis included ten non-randomized trials with 3,526 patients enrolled (sutureless group = 1,772 and rapid-deployment group = 1,754). Quality assessments were performed, with the mean scores of the studies reading 6.90 (SD = 0.99) out of 9 according to the Newcastle-Ottawa Scale. Compared with rapid-deployment aortic valve replacement, sutureless aortic valve replacement was associated with higher mean and peak transvalvular pressure gradients postoperatively. In contrast, aortic cross-clamp and cardiopulmonary time were needed less in sutureless aortic valve replacement vs. rapid-deployment aortic valve replacement. There was no evidence of significant publication bias observed by the funnel plot and Egger's test. For postoperative hemodynamics, sutureless aortic valve replacement was associated with increased mean and peak transvalvular pressure gradients compared with rapid-deployment aortic valve replacement. In sharp contrast, sutureless aortic valve replacement significantly reduced the amount of time needed for fixing the aortic cross-clamp and the cardiopulmonary bypass procedure. https://www.crd.york.ac.uk/prospero/, identifier CRD42022343884.

PO-04-016 FIRST REPORT OF LEADLESS PACEMAKER IMPLANTATION IN A PATIENT WITH BOTH A TRANSCATHETER TRICUPID VALVE REPAIR (TRICLIP) AND SURGICAL TRICUSPID VALVE ANNULOPLASTY

An increasing number of patients with valvular heart disease are undergoing novel structural valve interventions with subsequent need for pacemaker implantation. Leadless cardiac pacemakers (LCP) may be particularly suitable in patients with prior tricuspid valve interventions. However, the process of navigating previously repaired tricuspid valves (surgical or percutaneous) can be challenging. To our knowledge, implantation of an LCP in a patient with both surgical TV repair (annuloplasty) and transcatheter TV repair (TriClip, TTVr) has not been reported. In this case, intracardiac echocardiography (ICE) was used to navigate the LCP to its final implant position. To describe the feasibility of implanting an LCP in a patient with surgical and percutaneous tricuspid valve repairs, and the utility of ICE-guided implantation. N/A A 69 year old female with prior inferior vena cava (IVC) filter, percutaneous mitral valve repair (MitraClip) and transcatheter tricuspid valve repair (TriClip) underwent a BioBentall procedure with tricuspid valve repair (annuloplasty band). The existing clips were not removed at the time of surgery. She ultimately developed an indication for back-up ventricular pacing (intermittent high-degree AV block) and an LCP was recommended (Micra, Medtronic Inc., Minneapolis, MN). Under fluoroscopic guidance, the LCP introducer sheath (27 French outer diameter) was first traversed through the IVC filter into the right atrium. Then, using ICE to visualize the tricuspid valve and taking note of the clip position, the deflectable delivery system was maneuvered through the residual tricuspid valve orifice into the right ventricle while avoiding the clips via a superior and anterior approach. Positioning of the delivery system in the apical right ventricular septum in respect to the annuloplasty band and clips was confirmed on ICE imaging and fluoroscopy before and after deployment. LCP sensing, pacing threshold and impedance values were within normal limits. The severity of pre-existing moderate residual tricuspid regurgitation remained unchanged on follow up transthoracic echocardiography. Implantation of a leadless pacemaker after both transcatheter tricuspid valve repair and surgical tricuspid valve annuloplasty band is feasible. Steering through an anatomically challenging tricuspid valve neo-orifices can be performed safely and effectively under intracardiac echocardiography guidance.

Outcomes Associated With Early vs. Delayed Invasive Strategy in NSTEMI Complicated by High Degree AV Block: A Nationwide Analysis.

Background: High degree atrioventricular block (HDAVB) is an uncommon complication of non-ST-segment elevation myocardial infarction (NSTEMI) that frequently necessitates pacemaker implantation. This contemporary analysis compares need for pacemaker implantation based on the timing of intervention in acute NSTEMI complicated by HDAVB.Methods: We used 2016-2017 National Inpatient Sample database to identify admissions with NSTEMI and HDAVB. Time to coronary intervention from initial admission was used to segregate the admissions into two groups: early invasive strategy (EIS) (<24 hours) and delayed invasive strategy (DIS) (>24 hours). Multivariable linear and logistic regression analysis was performed to compare in-hospital outcomes among the two groups.Results: Out of 949,984 NSTEMI related admissions, coexistent HDAVB was present in 0.7% (n=6725) patients. Amongst those, 55.61% (n=3740) hospitalizations included invasive intervention (EIS=1320, DIS=2420). Patients treated with EIS were younger (69.95 years vs. 72.38 years, P<0.05) and had concomitant cardiogenic shock. Contrarily, prevalence of chronic kidney disease, heart failure, and pulmonary hypertension was higher in DIS group. EIS was associated with lower length of stay and total hospitalization cost. In-hospital mortality and pacemaker implantation rates were not significantly different between patients in the EIS and DIS groups.Conclusion: HDAVB is a rare complication of NSTEMI and often associated with right coronary artery disease. The timing of revascularization does not appear to influence the rate of pacemaker placement in NSTEMI complicated by HDAVB. Further studies are needed to assess if early invasive strategy can benefit all patients with NSTEMI and HDAVB.

Pacemaker Implantation following Heart Transplantation: Analysis of a Nation-Wide Database.

The 2018 United-Network-for-Organ-Sharing (UNOS) allocation-system changes resulted in greater recognition of mechanical circulatory support (MCS), leading to more heart transplantations (HTx) in patients with MCS. We aimed to investigate the effect of the new UNOS allocation system on the need for a permanent pacemaker and associated complications following HTx. The UNOS Registry was questioned, to identify patients that received HTx in the US between 2000 and 2021. The primary objectives were to identify risk factors for the need for a pacemaker implantation following HTx. 49,529 HTx patients were identified, 1421 (2.9%) requiring a pacemaker post-HTx. Patients who required a pacemaker were older (53.9 ± 11.5 vs. 52.6 ± 12.8 years, p < 0.001), more frequently white (73% vs. 67%; p < 0.001) and less frequently black (18% vs. 20%; p < 0.001). In the pacemaker group, UNOS status 1A (46% vs. 41%; p < 0.001) and 1B (31% vs. 27%; p < 0.001) were more prevalent, and donor age was higher (34.4 ± 12.4 vs. 31.8 ± 11.5 years; p < 0.001). One-year survival was no different between the groups (HR: 1.08; 95% CI: 0.85, 1.37; p = 0.515). An era effect was observed (per year: OR: 0.97; 95% CI: 0.96, 0.98; p = 0.003), while ECMO pre-transplant was associated with lower risk of a pacemaker (OR: 0.41; 95% CI: 0.19, 0.86; p < 0.001). While associated with various patient and transplant characteristics, pacemaker implantation does not seem to impact one-year survival after HTx. The need for pacemaker implantation was lower in the more recent era and in patients who required ECMO pre-transplant, a finding explained by recent advances in perioperative care.

Syncope After Transcatheter Aortic Valve Implantation: Pace or Not?

Syncope After Transcatheter Aortic Valve Implantation: Pace or Not?

Hybrid Ablation Versus Repeated Catheter Ablation in Persistent Atrial Fibrillation: A Randomized Controlled Trial

BackgroundAlthough catheter ablation (CA) is successful for the treatment of paroxysmal atrial fibrillation (AF), results are less satisfactory in persistent AF. Hybrid ablation (HA) results in better outcomes in patients with persistent atrial fibrillation (persAF), as it combines a thoracoscopic epicardial and transvenous endocardial approach in a single procedure. ObjectivesThe purpose of this study was to compare the effectiveness and safety of HA with CA in a prospective, superiority, unblinded, randomized controlled trial. MethodsForty-one ablation-naive patients with (long-standing)-persAF were randomized to HA (n = 19) or CA (n = 22) and received pulmonary vein isolation, posterior left atrial wall isolation and, if needed, a cavotricuspid isthmus ablation. The primary efficacy endpoint was freedom from any atrial tachyarrhythmia >5 minutes off antiarrhythmic drugs after 12 months. The primary and secondary safety endpoints included major and minor complications and the total number of serious adverse events. ResultsAfter 12 months, the freedom of atrial tachyarrhythmias off antiarrhythmic drugs was higher in the HA group compared with the CA group (89% vs 41%, P = 0.002). There was 1 pericarditis requiring pericardiocentesis and 1 femoral arteriovenous-fistula in the HA group. In the CA arm, 1 bleeding from the femoral artery occurred. There were no deaths, strokes, need for pacemaker implantation, or conversions to sternotomy, and the number of (serious) adverse events was comparable between groups (21% vs 14%, P = 0.685). ConclusionsHybrid AF ablation is an efficacious and safe procedure and results in better outcomes than catheter ablation for the treatment of patients with persistent AF. (Hybrid Versus Catheter Ablation in Persistent AF [HARTCAP-AF]; NCT02441738)

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.

In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; P<0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; P=0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P=0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P<0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P=0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P<0.001). TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Predictors of pacemaker implantation in patients with myocardial infarction and heart block

The aim of the study was to identify predictors of early and delayed pacemaker (PM) implantation in patients with myocardial infarction (MI) and heart block, allowing the development of models for predicting the feasibility of its implantation.Methods. A randomized selection method was used to form a cohort of patients with MI complicated by cardiac conduction disorders. The first (control) group included 72 patients who did not have a PM implanted, the second (n=46) and third (n=68) groups consisted of patients with MI, having, respectively, indications for early (in the acute period of MI) and delayed (average after 3 years) PM implantation. All patients underwent endovascular revascularization of the infarct-dependent artery during hospitalization. Demographic, clinical, and morphological predictors of PM implantation in patients of the second and third groups were evaluated in comparison with the control group. Multiple logistic regression was used to identify factors associated with the need for PM implantation in the short term (hospital period) and in the long-term period.Results. Factors that determine the expediency of a permanent PM in the acute period of MI at the hospital stage, delayed pacemaker implantation 3.2±1.9 years after myocardial infarction, as well as predictors that do not require a permanent PM throughout the entire observation period, were identified. The main factors that require permanent PM implantation in the acute period were identified: 3rd degree atrioventricular (AV) block in NSTEMI, GRACE score 96 or higher, development of 3rd degree AV block in MI of any localization except postero-inferior. Predictors for the need for PM implantation after 3.2±1.9 years (delayed period) were STEMI of anterior localization; at the same time, age had an inversely proportional relationship in predicting the fact of permanent pacing. The factors that determine the need for PM implantation are the presence of anterior MI, the multiple coronary artery lesions.Conclusion. In the acute (hospital) period of NSTEMI, PM implantation is indicated at a high risk of adverse cardiovascular complications (GRACE scale of 96 points and above), in the presence of the 3rd degree AV block in any MI localization, except for the inferior one. Indications for permanent pacing 3.2±1.9 years after an acute coronary event are STEMI of anterior localization and multiple coronary artery lesions.

Predictive Role of Aortic Valve Calcium score on post-procedural outcomes and mortality after Transcatheter aortic valve replacement

Abstract Introduction Extent of aortic valve (AV) calcium increases as degenerative aortic valve stenosis progresses. Initial studies postulated AV calcium (AVC) score to be a predictor of complications such as need for pacemaker implantation, paravalvular regurgitation and mortality after Trans-catheter Aortic valve Replacement (TAVR). However, evidence regarding the impact of AVC score as a predictor of post-procedural complications and mortality has been conflicting. Objective This study aimed to determine the prognostic impact of AVC as predictor of post-procedural outcomes and mortality in patients with severe aortic stenosis (AS) who underwent TAVR. Methods We retrospectively abstracted the records of 497 patients with severe AS who underwent TAVR between January 2016 and July 2019 at our institution. All patients underwent a non-contrast cardiac CT scan on a Siemens Somatom Definition Flash 128 slice scanner. AVC score using the Agatston method was obtained retrospectively. Patients were divided into two groups: 1) Non-severe AVC score group [women &amp;lt;1200 Agatston unit (AU) and men &amp;lt;2000 AU]; 2) Severe AV Calcium Score group [women &amp;gt;1200 AU and men &amp;gt;2000 AU]. Primary outcome was 1-year mortality. Results Among 466 patients included in the analysis, 352 patients were included severe AVC group while 114 patients were in the non-severe AVC group. Patients in the severe AVC group were older (81±8 vs 79±8 years), were predominantly males (79% vs 71%), and had less diabetes mellitus (31% vs 42%, p=0.02). Post-TAVR AV dimensionless index (0.58±0.13 vs 0.58±0.12, p=0.8) and AV mean gradient (9.5±4.9 vs 9.2±5.4 mmHg) were not statistically different between both groups. There was no statistical difference in the need for PPM (12% vs 7%, p=0.16), post-TAVR stroke (1.5% vs 0%), post-TAVR major complications (17.4% vs 10%, p=0.07), 30 day (3.7% vs 4.4%), and 1-year mortality (13.6 vs 11.4, p=0.6) between both groups. Conclusion Our study report that the severity of AVC score does not have a prognostic impact on major post-procedural outcomes and mortality after TAVR. Funding Acknowledgement Type of funding sources: None.

Early Versus Late Catheter Ablation of Atrial Fibrillation and Risk of Permanent Pacemaker Implantation in Patients With Underlying Sinus Node Dysfunction.

BackgroundAtrial fibrillation (AF) is associated with anatomical and electrical remodeling. Some patients with AF have concomitant sick sinus syndrome and may need permanent pacemaker (PPM) implantation. Association between catheter ablation of AF timing and need for PPM in sick sinus syndrome has not been assessed.Methods and ResultsWe used pooled electronic health data to perform retrospective cross‐sectional analysis of 66, 595 patients with AF and sick sinus syndrome to assess the need of PPM implantation temporally, with AF performed divided into earlier within 5 years (group 1), 5 to 10 years (group 2), or beyond 10 years (group 3) of diagnosis. PPM implantation was lowest among those who had catheter ablation within 5 years of sick sinus syndrome diagnosis: group 1 versus group 2 (18.15% versus 27.21%) and group 1 versus group 3 (18.15% versus 27.22%). Interestingly, there was no difference in risk of PPM between group 2 and group 3 (27.21% versus 27.22%; odds ratio [OR], 1.00 [95% CI, 0.85–1.20]).ConclusionsEven after controlling known risk factors that increase the need for pacemaker implantation, timing of AF ablation was the strongest predictor for need for PPM. Patients adjusted OR of PPM was lower if patients had catheter ablation within 5 years of diagnosis compared with later than 5 years (adjusted OR, 0.64 [95% CI, 0.59–0.70]).

Comparison of Outcomes of Transcatheter Aortic Valve Implantation in Patients With Versus Without Mitral Annular Calcium

There are limited data regarding the impact of mitral annular calcium (MAC) on the outcomes of patients who underwent transcatheter aortic valve implantation (TAVI). We performed a retrospective analysis of patients who underwent TAVI in 2018 and divided them into 2 groups based on the presence or absence of MAC, using a validated MAC computed tomography-based scoring system. Among 468 patients who underwent TAVI in 2018, 271 patients (58%) had MAC present compared with 197 patients (42%) without MAC. Compared with patients without MAC, patients in the MAC group were older (81 vs 79, p=0.012), had a higher body mass index (29.30 vs 28.05, p=0.031), lower left ventricular end-diastolic diameter (4.47 vs 4.80, p &lt;0.001), higher mitral valve mean gradient (4.54 vs 3.01, p=0.031), and a higher Society of Thoracic Surgeons risk score (5.69 vs 4.91, p=0.127). There was no significant difference in the with versus without MAC groups in the all-cause mortality (at 1 year: 9% vs 6%, p=0.8; at 2 years: 15% vs 13%, p=0.47), incidence of myocardial infarction (1% vs 2%, p=0.417), stroke (1% vs 3%, p=0.4), and major adverse cardiac and cerebrovascular events (17% vs 19%, p=0.53) at 1 year. Although the rate of new-onset left bundle branch block was higher in patients with MAC, there was no significant difference between the 2 groups in the rates of complete atrioventricular block (5% vs 3%, p=0.483) or the need for pacemaker implantation (6% vs 3%, p=0.168). The post-TAVI peak aortic valve gradient was comparable between the groups with and without MAC (22.52 vs 22.60, p=0.931). In conclusion, TAVI is a safe alternative for patients with severe aortic stenosis and concomitant MAC, with comparable outcomes to patients without MAC.