Pacemaker Research Articles

Mitral regurgitation improvement following left bundle branch pacing versus right ventricular septum pacing: a dedication to postoperative amelioration of mitral regurgitation

Abstract Background Mitral regurgitation (MR) is correlated with left ventricular (LV) remodeling and LV function in patients. Left bundle branch pacing (LBBP) exhibits a significant decline in MR in left bundle branch block (LBBB) and cardiomyopathy patients. This research aims to evaluate the influence of LBBP on MR in comparison to right ventricular septal pacing (RVSP) in patients with atrioventricular block (AVB) or sick sinus syndrome (SSS). Methods Sixty consecutive patients with SSS or AVB were enrolled if they underwent pacemaker implantation via LBBP or RVSP. Patients with a history of mitral valve surgery were excluded. Echocardiogram parameters were assessed to measure MR and LV remodeling as well as LV function at baseline and follow-up. Results Thirty-six patients (60 %; mean age: 70.39 ± 14.80 years; 61.1 % male) underwent successful LBBP, and 24 patients (40 %; mean age: 71.58 ± 10.91 years; 66.7 % male) underwent RVSP. The average follow-up duration was relatively comparable between the two groups. In comparison to RVSP, LBBP demonstrated significant changes in MR area, and severity at baseline and follow-up (P<0.05). LBBP independently predicted MR amelioration in patients who underwent pacemaker implantation (HR=0.289, CI=0.087–0.9961; P=0.043). At follow-up, the LBBP subgroup with moderate/severe MR exhibited significantly shorter lead-TVA-dist, higher left atrium (LA) diameters, and mitral E/A ratio (P<0.05) compared to the none/mild MR subgroup. In LBBP with MR amelioration, LV remodeling (ΔLVEDD) was significantly enhanced compared to baseline (P=0.016). Additionally, a non-significant trend toward better improvement in LV function (ΔLVEF and ΔE/A) was observed in patients with MR amelioration. Conclusion LBBP, considered an optimal pacing technique for SSS or AVB patients, may substantially reduce MR and subsequently enhance LV remodeling and function compared to RVSP. This open, observational pilot study warrants confirmation through further investigations.Comparison between LBBP and RVSPKaplan-Meier curves for MR amelioration

Electrical performance of a novel extravascular temporary pacing lead system

Abstract Background An investigational extravascular (EV) cardiac temporary pacing system has been developed that includes a parasternally-positioned temporary pacing lead within the anterior mediastinum. The pacing lead is inserted using a custom delivery tool through a parasternal skin incision. This novel system may provide clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact. Objective The purpose of this study was to evaluate electrical performance of an EV temporary pacing lead over 48 hours. Methods In this single-center study, patients who underwent a transvenous (TV) permanent pacemaker implant or replacement were simultaneously implanted with the investigational EV temporary pacing lead. Electrical performance was evaluated through analysis of capture thresholds, impedance, and R-wave amplitudes during multiple times on the day of the procedure and on the subsequent 2 days of follow-up. Results Lead insertions with acute capture were successful in all 8 patients (40% female, 71 ± 8 years, BMI 27 ± 3 kg/m2). Mean acute measurements for pacing capture threshold at 1.5 ms, impedance and R-wave amplitude were 6.2 mA, 1396 Ω, 5.4 mV, respectively. Pacing capture was maintained in 100% of assessments conducted over 3 days (Figure 1). There were no serious complications during insertion, removal or chronic use of the lead. Conclusions Results support that the investigational EV temporary pacing lead is capable of safely providing temporary pacing with thresholds typically well below the maximum output of temporary pacemakers.

Assessing the impact of implantable loop recorder placement on anxiety level

Abstract Background Anxiety is a prolonged state of apprehension or worry that can be an independent predictor of cardiovascular events, associated with a 48% increased risk of cardiac death. About one-third of patients with arrhythmias present with high anxiety levels, and subsequently worse quality of life. In our experience of patient care, many patients feel anxious about the possibility of an arrhythmia that could lead to their demise, especially if their symptoms are undiagnosed. Purpose Our project aims to explore the change in patients’ anxiety levels following implantable loop recorder (ILR) placement. Methods This is a survey-based observational study that was performed in an outpatient clinic and hospital using validated General Anxiety Disorder-7 (GAD-7) questionnaires. Individuals who met indications to undergo ILR implantation including palpitations, syncope, subclinical atrial fibrillation, and cryptogenic stroke underwent baseline assessment of anxiety prior to implantation. Individuals had repeat assessments at 6 weeks and 12 weeks post-implantation to evaluate the effect of ILR placement. Results Our study included 50 individuals. Out of the initial subjects, 10/25 females and 11/25 males were lost to follow-up. The average initial GAD-7 score was 3.3 (Range 0, 15), average 6-week score was 1.6 (Range 0, 14), and average 12-week score was 0.9 (Range 0, 10). Total decrease in GAD-7 score after 6 weeks of having ILR was 50%. Total decrease in GAD-7 score after 12 weeks of ILR was statistically significant at 73% (P=0.03). Females showed greater improvement of GAD-7 scores in comparison to males at 6 weeks (67% vs 36%) and 12 weeks (81% vs 66%). Conclusion Studies have suggested an overall decreased level of anxiety in patients receiving implantable devices that have the potential to treat arrhythmias such as implantable cardiac defibrillators and pacemakers. Our results suggest that the benefit may extend to implantable devices that seek to provide further diagnostic information and aid in the prognostication of disease burden. As seen in our study population, GAD-7 scores showed dramatic improvement with greater percentage in female than male population. After the placement of loop recorders, many patients experience a sense of security with having a device that monitors them. Our study is the first to address the association between ILR and anxiety. Future studies evaluating this association would help increase the power of the study.Figure 1:Bar graph of GAD-7 Scores

Interventional treatment of patients with hypertrophic obstructive cardiomyopathy: the immediate and long-term results

Abstract Background Alcohol septal ablation (ASA) is a widely accepted and effective procedure for reducing septal thickness in patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) who do not respond to medical treatment and have significant outflow tract gradients. Despite numerous studies confirming its safety and efficacy, as well as current guidelines from 2020 recommending ASA as a class 1 treatment option alongside surgical myectomy[1], the decision between these methods is still a subject of debate. Methods From 2009 to 2022 154 ASA performed in 145 patients (91 males, 54 females) with HOCM at our centre. Mean age of pts. was 42 [6;77] years. All pts. had right ventricle pacing lead with pacemaker backup and myocardial contrast ECHO(MCE) before procedure. Mean peak pressure gradient (PG) on LVOT was 93,5 ± 8,2 mm. Hg. Mitral valve regurgitation (MR) from moderate to severe was in all pts. Mean interventricular septum thickness was 2,5сm [1,6; 3,8]. Results Mean PG on LVOT decreased from 93,5 ± 8,2 mmHg to 31,7±4,3 mmHg. The grade of MR reduced from at least moderate to mild or even trivial. The procedure – related mortality was 1,3%. In 3 cases (2%) the procedure was aborted by he MCE data. Mean follow up for 145pts (100%)was 91±4,6 months. 112(77,3%) pts had PG reduction (to ≤30 mtmHg) – regarded as good result of procedure. 19 (13,1%) pts had PG > 30mmHg, but significant improvement in symptoms. Long term mortality in ASA pts. was 2.7%. 10(6.9%) pts needed redo procedure due to residual LVOTO, which was effective. 13(8,9%) patients had complete AV block and required permanent pacemaker. Mean interventricular wall thickness decreased from 2,5±0,3сm to 1,8±0,2cm. MR decreased from at least moderate to mild or complete disappearance. NYHA class reduced from 2,9 to 1,2. Conclusions ASA is effective and safe method of HOCM treatment. Accumulation of the experience can lead to a reduction in procedure time, a decrease in the number of complications, and an overall improvement in the outcomes of interventional HOCM treatment.

Implementing a novel selection criteria and pathway for same-day discharge after TAVI

Abstract Background The expansion in indications for transcatheter aortic valve implantation (TAVI) has fuelled an increase in demand worldwide. Prolonged waiting lists and waiting list mortalities are not infrequent and often arise from limited hospital capacity and infrastructure. Approaches to address this have included procedural modifications – ‘minimalist TAVI’ and more recently the development of pathways to facilitate early discharge post-TAVI, such as same-day discharge (SDD) post-procedure. Purpose This study aims to evaluate the safety and effectiveness of a novel SDD pathway a large volume tertiary referral cardiac centre. Methods A new SDD pathway was established between March 2023 and February 2024 at a large-volume tertiary cardiac centre in UK. All patients accepted for TAVI were screened for SDD suitability based on three factors: 1) availability of adequate social support, (defined as presence of able-bodies adult individual to assist in home recovery), 2) technically suitable for transfemoral approach and 3) presence of previous pacemaker or low risk for conduction abnormalities (defined as no baseline conduction disturbances). Following TAVI, patients were deemed suitable for SDD if they were clinically stable, the procedure was technically successful and there were no procedural complications. Demographic, clinical, procedural and outcome data were collected for all patients enrolled onto the SDD pathway and reasons for non-SDD were identified. Ethical approval was obtained in accordance with local institutional policies. Results From March 2023 to February 2024, 81 out of 305 patients (26.6%) were enrolled onto the SDD pathway (median age 82 years old, 66.7% male, median STS risk score 2.34%). Indications for TAVI were severe native aortic stenosis (74/81, 91.4%), severe native aortic regurgitation (2/81, 2.5%) and severe surgical valve degeneration (5/81, 6.2%). SDD was feasible for 58/81 (71.6%) of patients, with 10/81 (12.3%) discharged the following day and 13/81 (16.0%%) requiring >24 hours hospital admission (Figure 1). Reasons for non-SDD included new conduction abnormality (10/81, 12.3%), vascular complication (6/81, 7.4%), acute stroke (3/81, 3.7%), patient preference (2/81, 2.5%) and haemodynamic instability (2/81, 2.5%). Out of the 58 SDD patients, 25/58 (43.1%) had no previous permanent pacemaker system and in these patients a balloon-expandable valve was selected for 24/25 (96.0%) of patients (Figure 2). Conclusions Patient selection based on the presence of social support at home, low risk of conduction abnormalities or previous pacemaker combined with appropriate valve selection can facilitate a safe and effective SDD post-TAVI programme.

Impact of atrial fibrillation on progression of tricuspid regurgitation in patients undergoing transcatheter aortic valve replacement

Abstract Background Recent advancements in interventional cardiology have spurred growing interest in atrial tricuspid regurgitation (TR) as a potential therapeutic target. Atrial TR, a form of secondary TR, arises from the dilatation and dysfunction of the right atrium, frequently seen in the context of atrial fibrillation (AF). While the concept is increasingly recognized, the natural history of TR in relation to AF remains incompletely understood. Purpose This study aims to elucidate the impact of AF on the progression of TR in patients undergoing transcatheter aortic valve replacement (TAVR). Methods Utilizing data from a comprehensive single-center TAVR registry, this study included patients who underwent TAVR between 2016 and 2023, excluding those with severe TR post-TAVR. Subjects were categorized based on the presence or absence of paroxysmal or persistent/permanent AF/atrial flutter (AFL). The study employed the cumulative incidence function to depict the progression to severe TR, considering all-cause mortality as a competing risk. Results Among 981 eligible patients, 169 (17.2%) presented with AF/AFL, with 57 (5.8%) having persistent/permanent and 112 (11.4%) paroxysmal forms. Patients with AF/AFL had a higher surgical risk, a higher prevalence of significant mitral regurgitation and TR, and a lower left ventricular ejection fraction. The median follow-up period was 366 days, with an interquartile range from 36 to 1079 days. Over a 5-year period, 11.7% of patients with AF/AFL experienced progression to severe TR, with 14.2% in those with persistent/permanent AF/AFL and 10.6% in those with paroxysmal AF/AFL, compared to merely 0.8% in patients without AF/AFL (sub-distribution HR: 7.60, 95%CI: 2.86-20.0; P<0.001) (Figure 1). Multivariable Fine-Gray regression analysis showed that AF/AFL was associated with the progression of TR by at least one grade, independently of the TR grade post-TAVR and other echocardiographic parameters (sub-distribution HR: 1.38, 95% CI: 1.06-1.78; p=0.015). Other factors associated with progression included the TR grade post-TAVR (sub-distribution HR: 1.20, 95% CI: 1.05-1.38; p=0.009) and the presence of a permanent pacemaker (sub-distribution HR: 1.53, 95% CI: 1.18-1.71; p=0.001) (Figure 2). Conclusions The presence of AF/AFL significantly increases the risk of developing severe TR in the long-term following TAVR, underscoring the need for vigilant monitoring and potentially preemptive management strategies in this patient cohort.

Survival in very elderly patients with severe aortic stenosis submitted to TAVI compared to the general population

Abstract Introduction Severe aortic stenosis (AS) is the most common acquired valvular heart disease. Transcatheter aortic valve implantation (TAVI) is indicated as an alternative to surgery in patients (pts) with severe AS above 75 years old (yo) regardless of surgical risk. The prevalence of severe AS increases with age. In the very elderly, i.e. > 85yo, the presence of severe AS is often accompanied with important comorbidities and frailty. To improve pts assessment in the heart team, it is essential to characterize the outcomes of previous interventions in this challenging group of patients and that was the goal of the present study. Methods Single-center retrospective analysis, on prospectively collected data, of consecutive patients ≥85yo undergoing TAVI between 2015 to 2021. Successful TAVI, major procedural complications and 1-year mortality rates were defined according to the VARC-3 definition. Observed survival was compared to an age-matched population using life expectancy tables available at the portuguese National Statistics Institute. Simulated survival curves for an age-matched population were performed using an expected hazard rate of 0.14. This was a conservative approach assuming that mortality rate remained constant in the population during follow-up. Results A total of 767 pts underwent TAVI during the study period. Of these, 349 pts were ≥85yo and were included in our study. Median age was 87yo [IQR 86-89], 60% female (n = 211) with a median Euroscore II of 5% [IQR 4-7]. A total of 98 pts (28%) had previous coronary artery disease, 300 pts (85%) had chronic kidney disease and 22 pts (6%) had a previous stroke. Median mean aortic valve gradient was 49mmHg [IQR 42-60] and left ventricle ejection fraction was 55% [IQR 50-56]. 268 pts (77%) underwent an elective TAVI and the remaining 23% were urgent procedures after hospital admission. The transfemoral approach was used in 334 pts (96%) and 258 pts (74%) implanted a self-expanding valve. Median in-hospital time was 6 days [IQR 4-11] and most common complications were permanent pacemaker implantation (n=59, 17%) and major access-related complications (n=17, 5%). All-cause mortality at 30 days and 1 year were 2.1% (n=7) and 13.1% (n=46), respectively. This compares similarly to the group of younger pts (<85yo) which presented a 30 day and 1 year mortality of 2.8% and 12.8%, respectively. Among very-elderly, 35 pts (10%) were readmitted in the first-year post TAVI. The mean survival time in our cohort was 4.9 years compared to expected 6.2 years (figure, log-rank < 0.01). The mortality rate at one year was 13% (n = 46) in our cohort compared to expected mortality of 14% (n = 50), not statistically significant. Conclusion In this study, very old patients submitted to TAVI had a 1-year mortality rate similar to age-matched population and a mean survival time of more than 4 years, albeit inferior to an age-matched population.

Comparison of the effects of pre-dilatation with conventional versus larger balloon sizes on clinical outcomes in transcatheter aortic valve implantation with self-expandable valves

Abstract Background Transcatheter aortic valve implantation (TAVI) is considered an established treatment option for patients with severe aortic stenosis. When implanting self-expandable valve, pre-dilatation is often necessary to facilitate optimal transcatheter heart valve (THV) deployment. Traditionally, balloon sizes chosen for pre-dilatation are smaller than the minimum annulus diameter. Insufficient pre-dilatation can result in under-expansion of the THV, necessitating post-dilatation, and can increase the risk of complications. However, this conventional approach may not always yield the best outcomes, prompting a reassessment of balloon sizing strategies to improve procedural success and patient outcomes. Purpose The aim of this study was to investigate the impact on procedural outcomes of using larger balloons, sized less than the mean annulus diameter, for pre-dilatation compared to the traditional practice of using balloons sized less than the minimum annulus diameter during the implantation of self-expandable valves. Methods We analyzed 785 patients who underwent TAVI with self-expandable valve with pre-dilatation out of a consecutive 3880 cases at 6 centers from 2010 to 2023 (Figure 1). Among them, we divided the patients into two groups: those who underwent pre-dilation with balloons smaller than the minimum annulus diameter defined as the Conventional-size group and those who underwent pre-dilatation with balloons smaller than the mean annulus diameter defined as the Large-size group. The primary endpoint of this study was procedural success, stroke and need for permanent pacemaker implantation as designated by the VARC-3criteria. Results Of patients (69% female; mean age 84.9), there were 563 (71.7%) patients in the Conventional-size group and 222 (28.2%) patients in the Large-size group. There was no annulus rupture in either group. The incidence of post-dilatation was significantly higher in the Conventional-size group than in the Large-size group (109 of 563 [19.4%] vs. 23 of 222 [10.3%], p=0.001) (Figure 2). There was no significant difference in the incidence of primary endpoints (all p > 0.05). In post-echocardiographic outcomes, there was no significant difference in effective orifice area, mean pressure gradient, patients-prosthesis mismatch, or paravalvular leakage between the groups (P > 0.05). Conclusions This study demonstrates that a large-size strategy using a balloon smaller than the mean annulus diameter in the deployment of self-expandable valves is safe and may avoid the need for post-dilatation compared to the traditional strategy using a balloon smaller than the smallest diameter.

Transcatheter vs. surgical aortic valve replacement in patients with aortic stenosis and cardiogenic shock.

Patients with aortic stenosis (AS) and cardiogenic shock (CS) are an extremely high-risk population with a poor prognosis in the absence of definitive therapy. We aimed to compare the outcomes of transcatheter aortic valve replacement (TAVR) with those of surgical aortic valve replacement (SAVR) in patients with AS-CS. We queried the Nationwide Readmission Database (2016-21) to identify patients hospitalized for AS-CS who underwent isolated TAVR or SAVR. In-hospital outcomes of TAVR vs. SAVR were compared using multivariable regression and propensity-matching analyses. Ninety-day readmissions were compared using a Cox proportional hazards regression model. A total of 16 161 patients were hospitalized for AS-CS, of whom 6470 (40.0%) underwent isolated TAVR and 9691 (60.0%) underwent isolated SAVR. From 2016 through 2021, the proportion of TAVR increased from 29.5 to 46.5% and the proportion of SAVR correspondingly decreased in AS-CS (Ptrend < 0.01). After adjustment for baseline characteristics, TAVR was associated with lower odds of stroke [adjusted odds ratio (aOR) 0.63, 95% confidence interval (CI) 0.47-0.84], acute kidney injury (aOR 0.80, 95% CI 0.69-0.93), and major bleeding (aOR 0.54, 95% CI 0.40-0.71) and higher odds of vascular complications (aOR 1.56, 95% CI 1.23-1.97) compared with SAVR. In-hospital mortality, myocardial infarction, permanent pacemaker placement, and 90-day all-cause and heart failure readmissions showed similar rates between TAVR and SAVR. However, hospital length of stay was shorter and total costs and non-home discharges were lower with TAVR than with SAVR. This nationwide observational analysis showed that TAVR is increasingly performed in patients with AS-CS and is associated with similar rates of in-hospital mortality and 90-day readmissions but lower rates of in-hospital complications and resource utilization compared with SAVR.

Echocardiographic evaluation of right ventricle to pulmonary artery coupling in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis

Abstract Background Right Ventricle to Pulmonary Artery (RV/PA) uncoupling, which depicts the inability of RV contractility to match the increasing RV afterload, has recently gained recognition as a simple echocardiography parameter to aid prognosis judgment in patients with RV dysfunction. In Aortic Stenosis (AS) patients, the extent of RV dysfunction and Pulmonary Hypertension (PH) has been linked with poor outcomes, but the prognostic value of RV/PA uncoupling in AS patients undergoing TAVI has not been well-defined. Purpose To investigate the prognostic value of RV/PA uncoupling and its association with echocardiographic parameters in AS patients undergoing TAVI. Methods We conducted a systematic search through Pubmed and Embase to include studies up to February 2024. Studies were eligible if they evaluated the prognostic performance of RV/PA uncoupling in AS patients undergoing TAVI. Random-effects model were employed to pool the adjusted Hazard Ratio (aHR) with inverse-variance weighting method or Relative Risk (RR) with 95% Confidence Interval (95% CI) using Mantel-Haenszel test for categorical outcomes or Weighted Mean Difference (WMD) for numerical outcomes. Risk of bias assessment was conducted using the Newcastle Ottawa Scale (NOS). Results Thirteen studies were included. Out of 4,146 patients, 55.21% were reported to have RV-PA uncoupling prior to TAVI. RV/PA uncoupling was customarily assessed with TAPSE/PASP ratio, with threshold for uncoupling ranging between &amp;lt;0.31–&amp;lt;0.63 mm/mmHg. Follow-up period ranged between 6–65 months. Patients with baseline RV/PA uncoupling had lower LVEF (WMD -9.94% [-4.36– -15.53%]; I2 = 78%), lower TAPSE (WMD -4.98 mm [95% CI -1.15– -8.80]; I2 = 95%), and higher PASP (WMD 19.77 [95% CI 17.02–22.51]; I2 = 0%) compared to patients with RV/PA coupling at baseline. Baseline RV-PA uncoupling was an independent predictor of all-cause mortality (pooled aHR = 2.26 (95% CI 1.36–3.76); I2 = 77%) and composite endpoint of mortality and adverse cardiac or cerebrovascular events (pooled aHR = 2.07 (1.30–3.29); I2 = 24%). However, RV/PA uncoupling was not significantly associated with a higher risk of permanent pacemaker implantation after TAVI (pooled Risk Ratio 1.02 [0.70–1.47]; I2 = 0%). Conclusion Pre-procedural RV/PA uncoupling emerges as an independent predictor of worse prognosis in AS patients undergoing TAVI, contributing to a better understanding of the impact of this parameter on patient outcomes.

Safety and efficacy of transcatheter aortic valve implantation (TAVI) for pure aortic regurgitation; a systematic review and meta-analysis

Abstract Background Although Transcatheter Aortic Valve Implantation (TAVI) has gained ground in the management of severe aortic stenosis (AS), evidence about its safety and efficacy for patients with pure native aortic regurgitation (AR) remains limited. Purpose The aim of the study is to systematically review and summarize available data regarding the safety and the outcomes of TAVI in pure AR. Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 1, 2024, for studies assessing the characteristics and outcomes of patients undergoing TAVI for pure AR. Primary endpoint of our systematic review and meta-analysis is the in-hospital, 30-days and 1-year mortality rates. Secondary endpoints comprised in-hospital stroke, major bleeding, and permanent pacemaker implantation (PPM) implantation. Endpoint definitions followed the Valve Academic Research Consortium 2 criteria. The cumulative incidence of primary and secondary endpoints and the corresponding 95% confidence intervals (CI) were estimated. A random effects model (DerSimonian-Laird) was used to account for heterogeneity among the included studies. Results Our meta-analysis included a total of 22 studies and 6,710 patients undergoing TAVI for pure-AR. Our analysis showed that patients undergoing TAVI for pure AR had 3.4% (95% CI: 2%-4.7%), 7.9% (95% CI: 5.2%-10.6%) and 15.5% (95% CI: 9.9%-21.2%) in-hospital, 30-days and 1-year all-cause mortality. In-hospital stroke occurred in 1.9% (95% CI: 1.5%-2.2%) of the patients, while 4.9% (95% CI: 3.3%-6.6%) of the patients suffered from major bleeding events. Finally, considering the PPM implantation rates, patients had a 10.7% (95% CI: 7.4%-13.9%) in-hospital incidence. Conclusion Our systematic review and meta-analysis shows a promising safety profile for TAVI treating pure AR. It demonstrated relatively low in-hospital, 30-days and 1-year mortality incidence, comparable to the TAVI treating severe AS, according to the existing literature. Taking into consideration that TAVI for pure-AR might be the only therapeutic option for an increasing number of patients, further studies are needed to further assess the safety and efficacy of the procedure.TAVI for pure AR mortality rates

TAVI for treating severe aortic valve disease in cardiogenic shock: a single centre experience

Abstract Introduction Recent evidence shows the safety and efficacy of TAVI in patients with aortic valve disease (AVD) presenting in cardiogenic shock (CS). However, there is limited data regarding CS management in the cardiac intensive care unit (CICU) and its outcomes. We aimed to describe the CS features, pre-TAVI management and short-term clinical outcomes of a cohort of CS patients (pts) submitted to TAVI. Methods Single-centre retrospective registry of consecutive pts with AVD undergoing TAVI in CS, from January 2020 to October 2023. CS was defined as pre-procedural hypotension/hypoperfusion requiring vasoactive drugs or mechanical circulatory support (MCS) devices. The severity of CS was defined according to the SCAI classification. Procedural related outcomes according to the VARC-3 criteria and 30-day mortality were assessed. Results A total of 16 pts (1% of our global TAVI cohort, 62% male, mean age 79±5 years) meet the inclusion criteria. The majority (n=13) presented severe aortic stenosis, two had degenerated aortic bioprosthesis with severe regurgitation and one had native valve severe regurgitation. 6 pts (38%) had isolated left ventricle (LV) dysfunction and 10 (62%) had biventricular dysfunction. The admission LVEF was 33±8% and the mean transaortic gradient for those with aortic stenosis was 46±13mmHg. The EuroSCORE II estimated for a single non-CABG emergency procedure was 37±15%. All patients were refused for surgical treatment upon Heart Team discussion. At admission, 12 (75%) patients presented in CS SCAI-C, 1 (6%) in SCAI-D and 3 (19%) in SCAI-E. These last 3 patients presented in cardiac arrest upon admission to the CICU (time to ROSC from 2 to 15 minutes). The peak lactate level at 48 hours was 3.4 mmol/L [2.1-5.1] and the highest Vasoactive-Inotropic Score (VIS) during admission was 21 [11-45]. None of the patients needed MCS pre-TAVI. 5 (31%) patients required invasive mechanical ventilation and 5 (31%) renal replacement therapy. Median time between CICU admission and transfemoral TAVI was 2.5 days [IQR 1-7]. Procedural success was 100%, with 57% receiving a balloon-expandable and 43% a self-expandable valve. Post-TAVI CICU length of stay was 6 days [IQR 5-9]. Most common procedural complication were the need for permanent pacemaker implantation (n=2, 12%) and access-related bleeding (n=2, 12%). Hospital length-of-stay was 20±15 days. Thirty-day mortality was 12% (n=2). Conclusion In this cohort of CS patients selected for TAVI treatment, procedural success was achieved in all cases. While complications were similar to the general TAVI population, in-hospital mortality remained high but very acceptable. These results suggest that, if correctly selected, aortic valve disease patients in CS represent a niche for whom brief stabilization and urgent percutaneous valve treatment might impact their dismal prognosis.

Impact of aortic valve calcium score on conductive disturbances after transcatheter aortic valve implantation: a monocentre retrospective study

Abstract Introduction Conductive disorders requiring permanent pacemaker implantation (PPI) remain an important issue after transcatheter aortic valve implantation (TAVI). Aims To assess the impact of aortic valve calcium score (AVCS) on conductive disorders requiring PPI after TAVI. Methods All patients who underwent TAVI with an available AVCS from the pre-procedural CT-scan report from 2016 to 2022 were included in this retrospective single-centre study. The primary endpoint was the occurrence of a conductive disorder requiring PPI at 30 days. The association between PPI and AVCS was analyzed using multivariable logistic regression and receiver operating characteristics (ROC) curves analyses. Results Seven hundred and sixty-one patients were included, of whom 125 (16%) patients required a PPI at 30 days. AVCS score was significantly higher in patients requiring PPI (3788 (2487-5218) vs. 3050 (2043-4367) AU, p&amp;lt;0.001). Using multivariable analysis, pre-procedural right bundle branch block (OR=6.61, 95%CI=3.82-11.5, p&amp;lt;0.001), first atrioventricular block (OR=1.71, 95%CI=1.03-2.83, p=0.037), the use of a self-expanding valve (OR=3.25, 95%CI=1.17-9.09, p=0.025), and AVCS &amp;gt;4510 AU (OR=1.83, 95%CI=1.04-3.20, p=0.035) were independently associated with PPI. The area under the curve for ACVS to predict PPI was 60.3% (95%CI=54.7%-65.9%), indicating moderate discrimination. Of note, AVCS had an incremental discriminative value (C-index 0.79 vs 0.77, LR test p=0.036) over and above traditional PPI risk factors. Conclusion The results of our study suggest that a high AVCS is associated with an increased risk of PPI after TAVI.Central illustration

Safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with previous TAVI; a systematic review and meta-analysis

Abstract Background Transcatheter Aortic Valve Implantation (TAVI) has gained ground in the management of severe aortic stenosis, even in low-surgical risk patients. However, TAVI prostheses, like bioprostheses, have a finite lifetime; thus, TAVI in patients with previous TAVI (TAVI-in-TAVI) rates are radically increased. Although data regarding TAVI indicate low mortality and stroke rates within the first year, TAVI-in-TAVI is less studied. Purpose The aim of the study is to systematically review and summarize available data regarding the safety and the outcomes of TAVI-in-TAVI. Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 10, 2024, for studies assessing the characteristics and outcomes of patients undergoing TAVI-in-TAVI. Primary endpoint of our systematic review and meta-analysis is the in-hospital, 30-days and 1-year mortality rates. Secondary endpoints comprised in-hospital, 30-days and 1-year stroke rates, in-hospital vascular complications, conversion to surgery, coronary compression or obstruction, and perforation with or without tamponade, and in-hospital and 30-days permanent pacemaker implantation (PPM) implantation. Endpoint definitions followed the Valve Academic Research Consortium 3 criteria. The cumulative incidence of primary and secondary endpoints and the corresponding 95% confidence intervals (CI) were estimated. A random effects model (DerSimonian-Laird) was used to account for heterogeneity among the included studies. Results Our meta-analysis included a total of 5 studies and 2,145 patients undergoing TAVI-in-TAVI, 72.9% (N=1,564) of whom were treated with a balloon-expandable valve. Our analysis showed that patients undergoing TAVI-in-TAVI had 3.7% (95% CI: 1.6%-5.9%), 3.9% (95% CI: 3%-4.7%) and 12.5% (95% CI: 11%-14%) in-hospital, 30-days and 1-year all-cause mortality, while stroke occurred in 1.8% (95% CI: 1.2%-2.4%), 2.1% (95% CI: 1.4%-2.9%) and 3% (95% CI: 2.3%-3.8%) of the patients in-hospital, 30-days and 1-year, respectively. Notalby, conversion to surgery, coronary compression/obstruction and perforation with or without tamponade occurred in &amp;lt;1% of the patients, while 6.1% (95% CI: 2.2%-9.9%) of the patients had vascular complications during the procedure. Considering the PPM implantation rates, patients had a 1.8% (95% CI: 1.2%-2.4%) for in-hospital and a 6.8% (95% CI: 5.2%-8.3%) for 30-days incidence. Conclusion Our systematic review and meta-analysis is the first to present that TAVI-in-TAVI has an acceptable safety profile with relatively low in-hospital, 30-days and 1-year mortality and stroke rates, comparable to the native-valve-TAVI. Taking into consideration that TAVI-in-TAVI might be the only therapeutic approach for an increasing number of patients, further studies are warranted to further assess its safety and efficacy and to provide additional procedural techniques.TAVI-in-TAVI mortality rates

Permanent pacemaker implantation is associated with an increased risk of heart failure hospitalization in transcatheter aortic valve implantation patients with reduced systolic function

Abstract Background The impact of permanent pacemaker implantation (PPI) on outcome of patients following transcatheter aortic valve implantation (TAVI) is not fully understood. Purpose This study aimed to assess the impact of PPI on risk of two-year mortality and hospitalization due to heart failure (HF) in TAVI patients. Methods A total of 1275 consecutive patients who underwent TAVI at our hospital between 2009 and 2021 were enrolled in this study (mean age 81.4±5.6 years, 51.8% male). The primary endpoint was defined as two-year all-cause death after TAVI. The second endpoints included cardiovascular (CV) death and HF related hospitalization after TAVI. Results Among the 1275 patients following TAVI, 297 (23.3%) patients received PPI, with 134 receiving PPI before TAVI and 163 receiving PPI after TAVI. The patients were categorized into two groups: no PPI group (n=978) and PPI group (n=297). Compared to patients without PPI, patients who received PPI were more likely to be male (60.9% vs. 49.1%, P&amp;lt;0.001), higher prevalence of atrial fibrillation (51.2% vs. 43.3%, P=0.016), coronary artery disease (61.6% vs. 53.8%, P=0.017), use aldosterone receptor antagonists (MRAs, 25.3% vs. 15.2%, P&amp;lt;0.001), and lower left ventricular ejection fraction (LVEF, 54.9±13.1% vs. 57.5±11.4%, P&amp;lt;0.001). There were no significant differences in all-cause mortality (16.6% vs. 18.5%), CV mortality (11.3% vs. 13.5%), as well as HF hospitalization rate (18.5% vs, 21.2%) between the two groups (P&amp;gt;0.05). In this cohort, 1012 (79.4%) TAVI patients had a preserved LVEF (≥50%), 122 (9.6%) had a mildly reduced LVEF (41-49%), and 141 (11.1%) had reduced LVEF (≤40%). Their primary and secondary outcomes were similar among LVEF subgroups (all P&amp;gt;0.05). In the subgroup of reduced LVEF, the HF related hospitalization rate after TAVI was significantly higher in TAVI patients with PPI compared to those without PPI (30.6% vs. 13.0%, P=0.003). Multivariable Cox regression models demonstrated a 3-fold increased risk of HF related hospitalization in TAVI patients with PPI in comparison to those without PPI in the subgroup of LVEF≤40% (HR 3.057, 95% CI 1.311-7.130, P=0.010) after adjusting for age, sex, TAVI approach, atrial fibrillation, coronary artery disease, and the use of MRAs. Conclusion All-cause mortality and CV mortality are similar between TAVI patients with and without PPI. However, in the subset of TAVI patients with reduced LVEF (≤40%), PPI is associated with an increased risk of HF hospitalization. Efforts are thus needed to reduce the risk of HF hospitalization in these patients.

Mortality rates in patients undergoing urgent versus elective transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Background Patients with severe aortic stenosis (AoS) often present with acute heart failure and compensation, leading frequently to cardiogenic shock. Transcatheter Aortic Valve Replacement (TAVR) has been recently performed as a bailout treatment in such patients. The aim of our meta-analysis is to compare urgent TAVR to elective procedures. Methods We systematically screened three databases searching for studies comparing urgent versus elective TAVR. Primary endpoint is the 30-days mortality. Secondary endpoints included in-hospital mortality, device success, periprocedural vascular complications, 30-day stroke, 30-day acute kidney injury (AKI), permanent pacemaker implantation (PPM), moderate or severe paravalvular leakage and 30-day bleedings. Results Seventeen studies were included, with a total of 84,495 patients. Urgent TAVR was associated with an increased risk for 30-days mortality (RR: 2.53, 95% CI: 1.81 – 3.54), in-hospital mortality (RR: 2.67, 95% CI: 1.94 – 3.68), periprocedural vascular complications (RR: 1.91, 95% CI: 1.28 – 2.85) and AKI (RR: 2.83, 95% CI: 1.93 – 4.14), compared to elective procedure. No differences were observed in the rest secondary endpoints. Conclusions Urgent TAVR was associated with higher in-hospital and 30-day mortality, possibly driven by the increased incidence of AKI and vascular complications in urgent TAVR. The results highlight the importance of early TAVR in stable AoS patients.

Predisposing and precipitating factors of post-operative delirium after transfemoral TAVI

Abstract Background Transcatheter aortic valve implantation (TAVI) represents the treatment of choice for aortic stenosis (AS) patients at higher age (&amp;gt; 75y) or with relevant comorbidities. Post-operative delirium (POD) is a frequent complication which has been associated with worse outcome. Thus, preventive options are highly needed. The aim of our single-center study was to investigate predisposing and precipitating factors of POD after transfemoral TAVI, with a focus on the influence of anaesthesia. Methods Risk factors for POD after TAVI were analysed in 2 merged cohorts of 480 study patients (43% women; mean age 80 years), enrolled in 2017-2022 (n=375, TAVI in 95% in general anaesthesia) and in 2022-2024 (n=105, TAVI in 91% in local anaesthesia). Incidence of POD was evaluated retrospectively by nursing documentation, medical records, and DRG coding. The association of demographics, comorbidities, echo parameters, procedural parameters, anaesthesia, and peri-procedural complications with POD incidence was investigated. Results In total, 29 patients (6%) developed POD, with a tendency towards a lower incidence in the later cohort (6.7% vs. 3.8%; p=0.28). Regarding baseline characteristics, patients experiencing POD were more likely to be male (p=0.03), frail (Katz Index &amp;lt;6, p=0.049), and to suffer from low-gradient AS (p=0.005 for paradoxical, p=0.02 for classical low-flow, low-gradient AS; see also fig. 1A). Total procedure time was significantly longer in patients with POD (median, 86 vs. 62 min, p=0.004; fig 1B), and a tendency towards a more frequent implantation of other than ballon-expandable valves could be observed (p=0.07). Concerning the role of anaesthesia, POD did not differ significantly after general anaesthesia (n=24/360, 6.7%), conscious sedation (n=1/19, 5.3%), and local anaesthesia (n=4/100, 4%) (p=0.38). Regarding procedural complications, POD patients were characterized by lower minimum hemoglobin post-TAVI (9.3 vs. 10.1 g/dl, p=0.05; fig. 1C) and higher incidences of intra-procedural resuscitation (11% vs. 2%, p=0.03), cerebrovascular accidents (10% vs. 2%, p=0.04) and new permanent pacemaker implantations (25% vs. 10%, p=0.02). In POD patients, long-term survival after TAVI was significantly reduced, with a median survival of only 2 years (Kaplan-Meier curves in fig. 2; p=0.001). Conclusions POD after TAVI stays common and unfavourable. The role of anaesthesia seems less pronounced than expected. Total procedure time and relevant anaemia after TAVI emerged as most important modifiable risk factors. Future research is warranted, since strategies to reduce precipitating factors for POD may have a significant impact on post-TAVI outcomes.Selected risk factors for PODConsequence of POD: Reduced Survival

Contemporary implantation protocols enable markedly lower pacemaker rate for selfexpandable TAVR

Abstract Background Even in a low-risk cohort, the Evolut low-risk trial has reported a still rather high pacemaker implantation rate over 20%. In the recent years, contemporary implantation protocols have been introduced aiming on a higher implantation position. Purpose Data on a reduction of pacemaker rate in contemporary implantation practice is still limited. Methods We retrospectively analyzed baseline-characteristics and pacemaker-implantation rates after TAVR in patients being treated with a Medtronic Evolut Prosthesis for aortic valve stenosis in our center in the years 2018 (conventional implantation in 3-cusp view) vs. 2023 (contemporary implantation in cusp overlap technique). Results 160 Patients were retrospectively included. We found out, that contemporary implantation lead to a marked reduction of pacemaker rate (8.7 vs. 20.9%, p=0.047; HR 0.36[IQR 0.14-0.96; p=0.041]). While most baseline-parameters including age (83.5 (79.2/87.3) vs. 82.8 (79.4/86.2), p=0.654), LVEF (55.0 (54.3/57.8) vs. 55.0 (51.0/59.0), p=0.992) and overall risk score (Euroscore II 3.5 (2.5/4.7) vs. 3.6 (2.3/5.7), p= 0.726) had no relevant impact on pacemaker rate, female patients were less prone to receive a pacemaker (8.6% vs. 21.3%, p=0.030). Of all conduction disturbances before procedure, a pre-existing RBBB was strongly associated with a relevantly higher pacemaker rate (50.0% vs. 11.3% (p&amp;lt;0.001), HR 7.88 (IQR 2.73/22.74; p&amp;lt;0.001)). Furthermore, more severe leaflet calcification (p=0.049), a deeper implantation depth (6.0 (5.0/6.5) vs. 5.0 (4.0/60.), p=0.042), larger annular dimensions (perimeter 79.7 (75.2/87.7) 76.8 (71.9/80.7), vs. p=0.047) and prostheses sizes (Evolut 34 vs. smaller sizes 28.1 vs. 12.5%, p=0.053), higher BNP (547 (314/1488) vs. 396 (208/856)), p=0.039 and body weight (78.0 (71.3/90.0) vs. 73.0 (63.5/84.5), p=0.030) were attributed to a higher pacemaker rate. Conclusions In our retrospective database we demonstrated that a contemporary implantation protocol enabling higher implantation position leads to a significant reduction in pacemaker rate, even in the high-risk collective of patients with pre-existing RBBB (58.3 vs. 15.2%, p=0.002 compared to 33.3 vs. 6.3%, p=0.081).

Transcatheter aortic valve replacement with balloon-expandable and self-expandable valves in Japanese patients with large annulus: the OCEAN-TAVI registry

Abstract Background East Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve replacement (TAVR) outcomes in Asian patients with a large annulus. Purpose We aimed to compare the acute and long-term outcomes of TAVR using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. Methods We retrospectively analyzed the data from the Optimized transCathEter vAlvular interveNtion Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. A large annulus was defined by annular area ≥ 500 mm2 and average diameter ≥ 25 mm in computed tomography scans. The primary endpoint was the 3-year all-cause mortality. Secondary endpoints were 3-year heart-failure rehospitalization (HFR) after TAVR, acute outcomes of TAVR, and changes in valve function on echocardiography 2 years after TAVR. Results Among 773 patients, 671 (86.8%) underwent BEV-TAVR. The SEV-TAVR group showed a significantly higher incidence of above-moderate perivalvular leakage (2.1% vs. 7.8%; P &amp;lt; 0.001), and included a significantly greater percentage of patients who required postoperative pacemaker implantation (6.1% vs. 11.8%; P = 0.035). The incidence of moderate-to-severe prosthesis–patient mismatch did not differ between the two groups. The Kaplan–Meier curve showed no significant intergroup differences in the 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and the echocardiography-indexed effective orifice area and mean transaortic valve pressure gradient at 2 years post-TAVR did not differ significantly between the two groups. Conclusions The benefits of BEV-TAVR may outweigh those of SEV-TAVR in patients with a large annulus.

Long-term outcomes in women with a history of peripartum cardiomyopathy

Abstract Background Peripartum cardiomyopathy (PPCM) remains an important cause of cardiac-related maternal morbidity and mortality in previously healthy young women. Data on the long-term clinical course of PPCM are sparse. In this study, we report the long-term outcomes in patients with PPCM. Methods and Results Long-term follow-up (median 9.6, min 5, and max 24 years) was available in 72 women with PPCM followed in a cardio-obstetrics clinic. Five-year follow-up data were available for 19 PPCM patients, 10-year follow-up data for 24 PPCM patients, and more than 15 years of follow-up data for 24 PPCM patients. Seven patients were lost to cardiac follow-up but are known to be alive. The mean age at diagnosis was 35 ± 7 years, and 85% were Caucasian. The mean parity was 2.2 ± 1.3, and gravidity was 2.7 ± 1.7. Twin pregnancies were reported in 13% of cases. Pre-eclampsia was present in 25% of the patients and the development of hypertension in the long-term was documented in 18%. The mean LVEF was 34.5 ± 9.9% at diagnosis. One-year LVEF data were available in 72 patients: 54 patients (75%) experienced LV recovery (LVEF≥ 50%). After 1 year, the mean LVEF was 53.4± 8.2%. Among patients remained with LV&amp;lt;50% at one year (n=10) no LV function recovery was reported at long-term follow-up. At a median follow-up of 9.6 years (n=66) mean LVEF was 52.1±10.4%, nine patients had a reduction in LVEF (&amp;lt;50%) function in the long-term follow-up with a mean LVEF of 46.1± 2.1%. Out of 72 PPCM patients, 3 patients developed arrhythmia, in one woman coronary artery disease occurred and 7 underwent pacemaker implantation. Almost half of patients (n=65) remained with long term treatment of b-blockers, 38% received medications for hypertension or heart failure. No cases of myocardial infarctions, cardiovascular death, or heart transplantations were reported. Two women died during follow-up: one with normal LVEF died from breast cancer, and another patient with reduced LVEF and severe diabetes. The cause of her death remained unclear. During follow-up, 30 women had ≥ 1 subsequent pregnancy (SSP), and there was no reduction in their mean LVEF before SSP 57.0 ± 5.4% and at long-term follow-up was 59.6± 1.3% (p=ns). Conclusion Our study demonstrates favorable long-term outcomes with high and stable recovery rates with low mortality rates, and no impact of subsequent pregnancies on the clinical course of the condition. Nevertheless, persisting or new diagnosis of hypertension and use of cardiovascular medications were noted in the long term follow up.