Need For Permanent Pacemaker Implantation Research Articles

Técnica de superposición de cúspides en TAVI con el sistema autoexpandible Portico FlexNav

Introduction and objectivesThe cusp overlap technique (COT) has been proposed to reduce conduction disturbances (CD) after transcatheter aortic valve implantation (TAVI) with self-expanding supra-annular devices, but there are scarce data on COT with intra-annular valves. The aim of this study was to determine whether the use of the COT during Portico implantation results in higher valve implantation and lower rates of CD. MethodsWe included 85 patients undergoing TAVI with the Portico FlexNav system: 43 retrospective patients using the standard 3-cusp view and 42 prospective patients with the COT. Primary endpoints were implantation depth and new-onset CD (composite outcome of new-onset left bundle branch block and new permanent pacemaker implantation). ResultsCOT resulted in a higher implantation depth (noncoronary cusp: 4.9±3.9 vs 7.4±3.0; P=.005) and lower new-onset CD (31.0% vs 58.1%; P=.012), with a tendency toward a lower need for permanent pacemaker implantation (14.3% vs 30.2%, P=.078; 7.7% vs 31.0%; P=.011 in patients without pre-existing right bundle branch block). Transvalvular aortic gradients were slightly lower with COT (8.7±3.7 vs 11.0±6.1; P=.044). There were no differences in technical success or major procedure-related complications. On multivariate analysis, COT use was associated with a lower risk of new-onset CD. ConclusionsUse of the COT during Portico implantation is feasible and facilitates a higher valve implant, which in turn may help to reduce rates of new-onset CD.

PO-03-110 NEW INSIGHTS FROM HIS VENTRICULAR INTERVALS IN PATIENTS UNDERGOING TAVR AND IMPLICATIONS FOR PERMANENT PACING

Trans catheter aortic valve replacement (TAVR) represents a revolutionary treatment for patients with severe symptomatic aortic stenosis who are at high surgical risk. The rate of periprocedural complications has decreased over time. However, the incidence of conduction disease requiring permanent pacemaker (PPM) implantation has failed to decrease. The decision for PPM for conduction disease post TAVR is usually made based on ECG. It’s not uncommon for patients with conduction disease without evidence for infra-nodal block to receive a PPM, and pacing has been shown to have deleterious effects. To assess the utility of His Ventricular Interval (HVI) studies in predicting the need for PPM implantation. We included patients who underwent assessment of the AV nodal (AH interval) and the HVI pre and/or post TAVR and were continuously monitored until discharge and after discharge for 2 weeks. Repeat EP study was performed in the presence of new conduction disease during in-hospital or as an outpatient. PPM was recommended in the presence of complete heart block (CHB), infra-Hisian block or with an HV > 70 ms (discretion of the physician). Patients receiving PPM before 30 days were documented. Total of 71 patients who had pre and post TAVR EP study had follow up for at least 30 days. The Cohort predominantly male with an average age of 77 years. Forty-six patients received Edwards and 25 Medtronic valve. A total of 6 patients received PPM, 5 out of 6 within the index hospitalization, and 1 patient 5 days post discharge. Four out of 6 patients with PPM had Edwards and 2 out of 6 had Medtronic valve. Four out of 6 patient who received PPM, developed CHB during TAVR and HVI post TAVR was not measured; in 1 patient HVI could not be measured reliably because of atrial fibrillation and the other had normal pre and post HVI. Ten of 71 patients had pre-existing Bundle Branch Block (BBB). Four had right bundle branch block (RBBB) of which 1 required PPM, and 6 had left bundle branch block (LBBB) of which 1 required PPM. Six of 71 patients had new BBB post TAVR. 5 developed LBBB of which 2 required PPM, and 1 developed RBBB of which none required PPM In patients undergoing TAVR, pre and post TAVR EP study is very useful in determining the need for PPM. In the absence of significant infra-Hisian disease, Pre-TAVR RBBB or LBBB and new RBBB or LBBB are not an indication for PPM.Tabled 1HVI in pre-existing (Old)and post TAVR (new) Bundle Branch block (PO-03-110)Pre-existing LBBBPre-existing RBBBPost-TAVR (new) LBBBPost-TAVR (new) RBBBPatientPre-HVI (ms)Post-HVI (ms)PPM (yes/no)PatientPre-HVI (ms)Post-HVI (ms)PPM (yes/no)PatientPre-HVI (ms)Post-HVI (ms)PPM (yes/no)PatientPre-HVI (ms)Post-HVI (ms)PPM (yes/no)16063no155CHByes15255no14043no25060no25053no24871no35558yes35055no35058yes44548no44045no46063no55560no54859yes66373no Open table in a new tab

Blood versus crystalloid cardioplegia during triple valve surgery: A single center experience.

The efficacy of different cardioplegia solutions on outcomes of complex cardiac operations such as triple valve surgery (TVS) is scarce. Here we compared the outcomes in TVS patients receiving either crystalloid (Bretschneider) or blood (Calafiore) cardioplegia. Screening of our institutional database with prospectively entered data identified 471 consecutive patients (mean age 70.3 ± 9.2 years; 50.9% male), who underwent TVS (replacement or repair of aortic, mitral and tricuspid valve) between December 1994 and January 2013. In 277 patients, cardiac arrest was induced with HTK-Bretschneider solution (HTK, n = 277, 58.8%), whereas 194 received cold blood cardioplegia (BCP) according to Calafiore (n = 194, 41.2%). Comparisons of perioperative and follow up outcomes were made between cardioplegia groups. Preoperative patient characteristics and comorbidities were equally balanced between groups. 30-days mortality was similar between groups (HTK: 16.2%; BCP: 18.2%; p = 0.619). Incidence of the cumulative endpoint (30days mortality, myocardial infarction (MI), arrhythmia, low cardiac output syndrome or need for permanent pacemaker implantation) was also comparable (HTK: 47.6%; BCP: 54.8%, p = 0.149). In patients with reduced left ventricular ejection fraction (LVEF <40%), 30days mortality was higher in the HTK group (HTK 18/71 22.5%; BCP 5/50 10%; p = 0.037). Five-year survival was similar between groups (52 ± 6% for HTK and 55 ± 5% for BCP patients). In-Hospital mortality was best predicted by length of surgery and reperfusion ratio. Decreased age, shorter bypass time, preserved LVEF and concomitant surgical procedures have been found to be protective from long-term mortality. Myocardial protection with HTK shows equivalent outcomes compared to BCP during TVS. Patients with reduced left ventricular function may benefit from BCP during TVS.

Cusp-overlap technique during TAVI using the self-expanding Portico FlexNav system

Introduction and objectivesThe cusp overlap technique (COT) has been proposed to reduce conduction disturbances (CD) after transcatheter aortic valve implantation (TAVI) with self-expanding supra-annular devices, but there are scarce data on COT with intra-annular valves. The aim of this study was to determine whether the use of the COT during Portico implantation results in higher valve implantation and lower rates of CD. MethodsWe included 85 patients undergoing TAVI with the Portico FlexNav system: 43 retrospective patients using the standard 3-cusp view and 42 prospective patients with the COT. Primary endpoints were implantation depth and new-onset CD (composite outcome of new-onset left bundle branch block and new permanent pacemaker implantation). ResultsCOT resulted in a higher implantation depth (noncoronary cusp: 4.9±3.9 vs 7.4±3.0; P=.005) and lower new-onset CD (31.0% vs 58.1%; P=.012), with a tendency toward a lower need for permanent pacemaker implantation (14.3% vs 30.2%, P=.078; 7.7% vs 31.0%; P=.011 in patients without pre-existing right bundle branch block). Transvalvular aortic gradients were slightly lower with COT (8.7±3.7 vs 11.0±6.1; P=.044). There were no differences in technical success or major procedure-related complications. On multivariate analysis, COT use was associated with a lower risk of new-onset CD. ConclusionsUse of the COT during Portico implantation is feasible and facilitates a higher valve implant, which in turn may help to reduce rates of new-onset CD.

Reduction of permanent pacemaker implantation by using the cusp overlap technique in transcatheter aortic valve replacement: a meta-analysis

BackgroundThe need for permanent pacemaker (PPM) implantation is a common complication after transcatheter aortic valve replacement (TAVR). Deep implantation position is a risk factor for PPM implantation. Thus, in the field of self-expandable (SE) transcatheter heart valves (THV) cusp overlap projection (COP) technique was implemented to reduce parallax, allowing a more precise guidance of implantation depth.AimsThis meta-analysis aims to report the outcome of patients undergoing TAVR with SE THV using COP versus conventional implantation technique (CIT).MethodsSystematical search in MEDLINE and EMBASE yielded five observational controlled studies comparing both implantation techniques for the SE Evolut prosthesis (Medtronic Intern. Ltd., CA, USA) and fulfilling the inclusion criteria for meta-analysis.ResultsTotally, 1227 patients were included, comprising 641 who underwent COP and 586 CIT TAVR. Incidence of post-procedural need for PPM implantation was significantly lower in COP group (9.8% vs 20.6%; OR = 0.43; p < 0.00001). This was accompanied by significantly higher implantation position in COP group (mean difference distance from distal end of the intraventricular portion of the THV to the non-coronary cusp (NCC): − 1.03 mm; p = 0.00001). Incidence of new-onset left bundle branch block did not differ. Regarding procedural and 30-day mortality, technical success, post-procedural aortic regurgitation, and rates of multiple device implantation, no difference between COP and CIT was found.ConclusionCOP is an effective and safe implantation technique to reduce the need for a permanent pacemaker implantation during TAVR with SE Evolut prosthesis.Graphical abstract

Trend, Predictors, and Outcomes of Transcatheter Aortic Valve Implantation in Patients With End-Stage Renal Disease: Insights From the Nationwide Readmissions Database

BackgroundTranscatheter aortic valve implantation (TAVI) is the standard of care for patients with severe aortic valve stenosis (AS). However, evidence on its safety in patients with end-stage renal disease (ESRD) is limited. MethodsThe Nationwide Readmissions Database (NRD) from 2015 to 2019 was queried to identify patients undergoing TAVI in ESRD versus patients with no ESRD. The in-hospital, 30-day and 180-day outcomes were assessed using a propensity-score matched (PSM) analysis to calculate adjusted odds ratios (aOR). ResultsA total of 198,816 underwent TAVI, of which 34,546 patients (TAVI-ESRD 16,986 vs. non-ESRD 17,560) were selected using PSM analysis. The adjusted odds of net adverse cardiovascular events (NACE) (aOR 1.65, 95 % CI 1.49–1.82), in-hospital mortality (aOR 2.99, 95 % CI 2.52–3.55), major bleeding (aOR 1.21, 95 % CI 1.05–1.40), postprocedural cardiogenic shock (aOR 1.54, 95 % CI 1.11–2.13), and need for permanent pacemaker implantation (PPM) (aOR 1.24, 95 % CI 1.15–1.38) were significantly higher in TAVI-ESRD patients compared with non-ESRD patients at index admission. There was no significant difference in the odds of stroke (aOR 1.09, 95 % CI 0.86–1.34) and cardiac tamponade (aOR 1.06, 95 % CI 0.78–1.45) between the two groups. At 30- and 180-day follow-up, the odds of readmission, NACE, and mortality remained high in TAVI-ESRD patients. ConclusionESRD patients undergoing TAVI have a high risk of NACE, in-hospital mortality, and major bleeding compared with patients with no ESRD.

Atrial approaches in mitral valve surgery: a propensity analysis of differences in the incidence of clinically relevant adverse effects

BackgroundThe lack of evidence on complications using mitral valve approaches leaves the choice of risk exposure to the surgeon’s preference, based on individual experience, speed, ease, and quality of exposure.MethodsThe present study analysed patients undergoing mitral valve surgery using a superior transseptal approach or a left-atrial approach between 2006 and 2018. We included first-time elective mitral valve procedures, isolated, or combined, without a history of rhythm disturbances. We used propensity score matching based on 26 perioperative variables. The primary endpoint was the association between the superior transeptal approach and clinically significant adverse outcomes, including arrhythmias, need for a permanent pacemaker, cerebrovascular events, and mortality.ResultsA total of 652 patients met the inclusion criteria; 391 received the left atrial approach, and 261 received the superior transseptal approach. After matching, 96 patients were compared with 69 patients, respectively. The distribution of the preoperative and perioperative variables was similar. There was no difference in the incidence of supraventricular tachyarrhythmias or the need for treatment. The incidence of nodal rhythm (p = 0.008) and length of stay in intensive care (p = 0.04) were higher in the superior transseptal group, but the need for permanent pacemaker implantation was the same. Likewise, there was no difference in the need for anticoagulation due to arrhythmia, the incidence of cerebrovascular events or mortality in the postoperative period or in the long-term follow-up.ConclusionWe did not find an association with permanent heart rhythm disorders or any other significant adverse clinical outcome. Therefore, the superior transeptal approach is useful and safe for mitral valve exposure.

Permanent Pacemaker Insertion Reduction and Optimized Temporary Pacemaker Management After Contemporary Transcatheter Aortic Valve Implantation With Self-Expanding Valves (from the Pristine TAVI Study)

Permanent pacemaker implantation (PPMI) reduction and optimal management of newly acquired conduction disturbances after transcatheter aortic valve implantation (TAVI) are crucial. We sought to evaluate the relation between transcatheter heart valve (THV) implantation depth and baseline and newly acquired conduction disturbances on PPMI after TAVI. This study included 1,026 consecutive patients with severe symptomatic aortic stenosis (mean age 79.7±8.4years; 47.4% female) who underwent TAVI with the newer-generation self-expanding THVs Primary outcomes were early and late PPMI defined as the need for PPMI during the index admission and between discharge and 30days, respectively. Early and late PPMI was required for 115 (11.2%) and 21 patients (2.0%), respectively. Early PPMI rates decreased from 26.7% in 2015 and 2016 to 5.7% in 2021, and so did the mean THV depth from 4.4±2.4mm to 1.8±1.6mm. Receiver operator characteristics curve analyses showed THV depth had significant discriminatory value for early and late PPMI with cutoff values of 3.0 and 2.2mm, respectively. Rates of early and late PPMI were significantly lower for patients with shallower compared with deeper implantations (5.1% vs 22.6% and 0.4% vs 4.1%, p<0.001 for both, respectively). Furthermore, rates of early PPMI were lower with shallower implantations in patients with new left bundle branch block after TAVI (2.4% vs 15.9%; p<0.001) and those with baseline right bundle branch block (7.5% vs 29.6%; p=0.017). Lower rates of PPMI with shallower THV implantation were consistently observed, including in patients with baseline and newly acquired conduction disturbances. Our findings might help optimize the management of a temporary pacemaker after TAVI.

Trends and In-Hospital Outcomes of Patients With Baseline Right Bundle Branch Block Who Underwent Transcatheter Aortic Valve Implantation

This study aimed to explore contemporary in-hospital outcomes and trends of transcatheter aortic valve implantation (TAVI) outcomes in patients with baseline right bundle branch block (RBBB) using data collected from a nationwide sample. Using the National Inpatient Sample, we identified patients hospitalized for an index TAVI procedure from 2016 to 2019. Primary outcomes included in-hospital all-cause mortality, complete heart block, and permanent pacemaker (PPM) implantation. A total of 199,895 hospitalizations for TAVI were identified. RBBB was present in 10,495 cases (5.3%). Patients with RBBB were older (median age 81 vs 80years, p <0.001) and less likely to be female (35% vs 47.4%, p <0.001). After adjusting for differences in baseline characteristics and elective versus nonelective admission, patients with RBBB had a higher incidence of complete heart block (adjusted odds ratio [aOR] 4.77, confidence interval [CI] 4.55 to 5.01, p <0.001) and PPM implantation (aOR 4.15, CI 3.95 to 4.35, p <0.001) and no difference in-hospital mortality rate (aOR 0.85, CI 0.69 to 1.05, p=0.137). Between 2016 and 2019, there was a 3.5% and 2.9% decrease in in-hospital PPM implantation in patients with and without RBBB, respectively. In conclusion, from 2016 to 2019, the rate of in-hospital PPM implantation decreased during index TAVI hospitalization in both patients with and without RBBB. However, in those with baseline RBBB, complete heart block complication rates requiring PPM implantation remain relatively high. Further research and advances are needed to continue to reduce complication rates and the need for PPM implantation.

Abstract 11555: Risk Factors Associated With Pacemaker Implant Following Hospital Discharge, Within 30 Days of TAVR

Introduction: Delayed conduction abnormalities can occur after transcatheter aortic valve replacement (TAVR) in a small but significant group of patients and may be associated with out-of-hospital adverse events including syncope and need for urgent permanent pacemaker (PPM) implantation. There are limited data on the factors associated with need for PPM implantation following TAVR hospital discharge. Methods: A single-center retrospective analysis of TAVR patients (2011-2019) was performed. Exclusion criteria included presence of a PPM prior to TAVR, PPM implant during index admission for TAVR, and absence of pre-TAVR ECG data. The primary endpoint was PPM implantation occurring after hospital discharge, within 30 days of TAVR (late PPM). Results: Of 1148 TAVR procedures performed during the study period, 850 (79.7 ± 9.3 years old, 53.8% male) were included in analysis. There were 16 patients (1.88%) who required late PPM implantation. The median duration of time between discharge and late PPM was 4 (2.8-9.3) days. Univariate analysis revealed that pre-existing right bundle branch block, and change in PR interval from pre-TAVR through day of discharge was associated with late PPM (Figure). Notably, new left bundle branch block was not associated with late PPM. Multivariate analysis demonstrated that change in PR interval from pre-TAVR through day of discharge was independently associated with late PPM. The rate of late PPM increased linearly with greater PR prolongation (y=1.10x-1.01, r2=0.93), and patients with PR increase &gt;20ms had a 4.8% rate of late PPM implantation (Figure). Conclusions: PR prolongation through day of discharge independently predicted need for late PPM following TAVR in our single center experience. Patients with PR increase &gt;20ms from baseline are at particularly high risk for late PPM and should be counseled about the potential need for future PPM.

Abstract 14282: Outcomes Following Aortic Valve Replacement Among Kidney Transplant Recipients. A Systematic Review and Meta-Analysis

Introduction: While kidney transplant recipients (KTR) are high risk candidates for valve replacements, the safety of transcatheter aortic valve replacement (TAVR) is limited among this population as they are excluded from major trials. We aimed to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) among KTR by a systematic review and meta-analysis. Methods: We comprehensively searched PubMed, Embase, and Cochrane Library from its inception until April 20, 2022 for relevant studies. Outcomes were pooled using the DerSimonian and Laird random-effects model and reported as odd ratios (OR) or standardized mean difference (SMD) and 95% confidence intervals (CI). Results: 6 studies involving 5,452 patients (1,956 TAVR, 3,496 SAVR) were included in the analysis. TAVR patients were older (69.4 years vs 62.8 years), were less likely to be male (66.7% vs 67.9%) and had a higher prevalence of most comorbidities including coronary artery diseases (78% vs 58%), heart failure (71% vs 42%) and diabetes mellitus (52% vs 45%). Compared with SAVR, KTR undergoing TAVR had significantly lower risk of in-hospital all-cause mortality (OR 0.51, 95% CI: 0.39 to 0.67, p&lt;0.001), acute kidney injury (RR 0.49, 95% CI: 0.34 to 0.71, p&lt;0.001), blood transfusion (OR 0.29, 95% CI: 0.19 to 0.55, p&lt;0.001) and a shorter length of hospital stay (SMD -0.67, 95% CI: -1.10 to -0.24, p=0.002). In contrast, there was a higher need for permanent pacemaker implantation among the TAVR cohort compared to SAVR cohort (OR 3.44, 95% CI: 2.67-4.43, p&lt;0.001). Conclusions: TAVR appeared to be a safe alternative compared to SAVR in KTR, with a lower rate of short-term mortality, AKI and length of hospitalization but a higher rate of permanent pacemaker implantation. Further studies are encouraged to study the long-term outcomes among these patients.

Sex-based differences of the impact of aortic valve calcium score on mortality and post-procedural outcomes after trans-catheter aortic valve replacement

Abstract Introduction Sex based differences exist in the presentation, outcomes, and management of cardiovascular diseases. Although aortic valve calcium (AVC) score has been postulated to be associated with post-procedural outcomes after transcatheter aortic valve replacement (TAVR), data on the impact of AVC score on procedural outcomes after TAVR based on sex have been scarce. Objective The aim of the present study was to elucidate sex related differences in the prognostic impact of AVC score as a 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 calculated retrospectively. Primary outcome was 1-year mortality. 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 AVC Score group [women &amp;gt;1200 AU and men &amp;gt;2000 AU]. Cox-regression model was used to predict effect of variables on 1-year mortality in male and female patients. Results Among 466 patients included, 268 patients were male and 198 were female (57.5% vs 42.5%). When compared with males, female patients had significantly lower AVC score (p&amp;lt;0.001), aortic valve area (AVA) (p&amp;lt;0.001), obstructive CAD (p&amp;lt;0.001), and history of previous PCI (p&amp;lt;0.004), and CABG (&amp;lt;0.001) but had a significantly higher STS score (6.7±3.2 vs 5.8±3.3 P=0.01). There was no difference between need for permanent pacemaker (PPM) implantation (11% vs 9.6%, p=0.4), major complications (16% vs 15%, p=0.9), stroke (0.8% vs 1.6%, p=0.7), 30-day (3.7% vs 4%, p=0.9), and 1-year mortality (14% vs 12%, p=0.6) between males and females, respectively. Female patients required smaller bio-prosthetic valves compared with males (26±3.2 vs 30±3, p&amp;lt;0.001). Cox regression analysis for female patients showed BMI, hemoglobin level, and AVA independently predicted 1-year mortality, while there was no impact of severe AVC score (&amp;gt;1200 AU) on 1-year mortality in females. Similarly, Cox regression analysis for male patients showed there was no impact of severe AVC score (&amp;gt;2000 AU) on 1-year mortality in males. When males in the severe AVC group were compared with female patients in the severe AVC group, there was no difference in 30 day (4.3% vs 3.3%, p=0.82) and 1-year mortality (14.2% vs 13.3%, p=0.77). Similarly, in the severe AVC group there was no difference between need for PPM implantation (12.8% vs 12.1%, p=0.9), major complications (19.7% vs 15.8%, p=0.4), and stroke (2.2% vs 1%, p=0.6) between males and females, respectively. Conclusion There were no sex differences in the impact of AVC score on mortality and post-procedural outcomes after TAVR. Funding Acknowledgement Type of funding sources: None.

Membranous septum length as predictor for permanent pacemaker implantation after TAVI

Abstract Background High-degree atrioventricular (AV) block and permanent pacemaker (PPM) implantation represent major complications after transcatheter aortic valve implantation (TAVI). Extension of indication for TAVI towards subjects with lower surgical risk requires to reduce the likelihood for the requirement of permanent pacemaker (PPM) implantation. Data on the role of membranous septum length as potential predictor for AV block after TAVI are scarce. Purpose We examined the role of membranous septum length as potential predictor for AV block and the need for PPM implantation in a large cohort of consecutive subjects after TAVI. Methods In a cohort of 1365 patients without prior permanent pacemaker who underwent transfemoral TAVI, clinical and procedural characteristics were assessed systematically. Based on cardiac computed tomography performed prior to TAVI, membranous septum length was measured orthogonal to the anulus plane (see figure). Results Median age of subjects was 81 (IQR 7) years, 50% were male. Logistic euroSCORE was 12.8 (IQR 15.7), STS score 3 (2.7). 9,8% of subjects had a pre-interventional complete right bundle branch block (RBBB). 71% of patients received a balloon-expandable, 29% a self-expandable valve. In n=153 patients (11.2%), PPM implantation was necessary due to high-degree AV block. Median membranous septum length was 2.9 mm (IQR 2.5mm) in subjects who received a PPM versus 4.3 mm (IQR 3.2 mm) in subjects who did not need a PPM (p=0.061). In univariate regression analysis, pre-interventional complete RBBB (p&amp;lt;0.001, OR 7.8), implantation of a self-expandable prosthesis (p=0002, OR 1.7) and membranous septum length (p=0.027, OR 0.9 per 1 mm) were identified as significant predictors for PPM implantation. In multivariate regression analysis, all parameters remained significant, including membranous septum length (p=0.009, OR 0.9 per 1 mm). Conclusion In a large cohort of consecutive patients, we were able to confirm the significant independent predictive value of membranous septum length, in addition to pre-interventional complete RBBB or implantation of a self-expandable prosthesis, regarding the occurrence of post-procedural AV block with the need for PPM implantation. The results may contribute to improved risk stratification for potential PPM implantation after TAVI. Funding Acknowledgement Type of funding sources: None.

Trends in outcomes, complications and readmission rates in patients undergoing transcatheter aortic valve implantation: a nationwide analysis from 2012 to 2019

Abstract Background Transcatheter aortic valve implantation (TAVI) has evolved over the years from a procedure requiring surgical vascular access and general anesthesia, to one that can be completed entirely percutaneously with conscious sedation. Advancement in procedural techniques and operator experience has resulted in better outcomes for patients undergoing TAVI. Purpose The purpose of our study was to analyze the trends over the years in outcomes, complications and unplanned readmission rate in patients undergoing TAVI. Methods The United States Nationwide Readmission Database for the years 2012 to 2019 was queried to identify all adult patients who underwent elective TAVI. The primary outcome of the study was inpatient mortality during TAVI hospitalization. Secondary outcomes included periprocedural complications (like acute kidney injury, bleeding requiring transfusion, need for permanent pacemaker implantation, stroke), length of stay, hospitalization cost, and unplanned 30-day readmission rate. Appropriate International Classification of Diseases (ICD-9 and ICD-10) codes were used to identify comorbidities and complications. Results A total of 283,409 patients who underwent TAVI were included in the study. The baseline characteristics of these patients are shown in picture 1. The inpatient mortality during TAVI admission declined steadily and significantly from 5.3% in the year 2012 to 0.0% in the year 2019 (p value for trend &amp;lt;0.001). There was a significant reduction in peri-TAVI occurrence of acute kidney injury (from 18.1% in 2012 to 8.7% in 2019), bleeding requiring transfusion (from 28.0% in 2012 to 4.3% in 2019), and stroke (from 1.8% in 2012 to 0.1% in 2019) (p value for trend &amp;lt;0.001 for all). Periprocedural conduction abnormalities requiring permanent pacemaker implantation increased from 7.4% in 2012 to 12.1% in 2015, before coming down to 8.9% in 2019 (p value for trend &amp;lt;0.001). The mean length of hospital stay and inflation-adjusted costs during admission for TAVI decreased from 9.6 days and $64,695 in the year 2012, to 3.6 days and $49,710 in the year 2019, respectively (p value for both &amp;lt;0.001). The unplanned 30-day all-cause readmission rate after TAVI also reduced steadily and significantly from 18.2% in 2012 to 11.5% in 2019 (p value &amp;lt;0.001). Conclusion Over the years, there has been a significant reduction in inpatient mortality, periprocedural complications (such as acute kidney injury, need for blood transfusion, stroke), length of hospital stay, and inflation-adjusted hospital costs in patients undergoing transcatheter aortic valve implantation. Furthermore, there has been a significant decline in the 30-day unplanned readmission rate after transcatheter aortic valve implantation. 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]).

Permanent pacemaker implantation after valve and arrhythmia surgery in patients with preoperative atrial fibrillation.

Among patients referred for cardiac surgery, atrial fibrillation (AF) is a common comorbidity and a risk factor for postoperative arrhythmias (eg, sinus node dysfunction, atrioventricular heart block), including those requiring permanent pacemaker (PPM) implantation. The purpose of this study was to evaluate the prevalence and long-term survival of postoperative PPM implantation in patients with preoperative AF who underwent valve surgery with or without concomitant procedures. Presented analysis pertains to the HEIST (HEart surgery In atrial fibrillation and Supraventricular Tachycardia) registry. During the study period, 11,949 patients underwent valvular (aortic, mitral, or tricuspid valve replacement or repair) surgery and/or surgical ablation (SA) and were stratified according to postoperative PPM status. PPM implantation after surgery was necessary in 2.5% of patients, with significant variation depending on the type of surgery (from 1.1% in mitral valve repair to 3.3% in combined mitral and tricuspid valve surgery). In a multivariate logistic regression model, tricuspid intervention (P <.001), cardiopulmonary bypass time (P = .024), and endocarditis (P = .014) were shown to be risk factors for PPM. Over long-term follow-up, PPM was not associated with increased mortality compared to no PPM (hazard ratio 0.96; 95% confidence interval 0.77-1.19; P = .679). SA was not associated with PPM implantation. However, SA improved survival regardless of PPM status (log rank P <.001). In patients with preoperative AF, the need for PPM implantation after valve surgery or SA is not an infrequent outcome, with SA not affecting its prevalence but actually improving long-term survival.

Multi-Center Comparison of Two Self-Expanding Transcatheter Heart Valves: A Propensity Matched Analysis.

Background: During the last years, several transcatheter aortic heart valves entered the clinical market and are commercially available. The prostheses differ regarding several technical and functional aspects. However, little is known regarding head-to-head comparative data of the ACURATE neo and the PORTICO valve prostheses. Objectives: The aim of this study was to compare two self-expanding transcatheter aortic heart valves (THV), the ACURATE neo and the PORTICO, with regard to in-hospital and 30-day outcomes, as well as early device failures. Methods: A total of 1591 consecutive patients with severe native aortic valve stenosis from two centers were included in the analyses and matched by 1:1 nearest neighbor matching to identify one patient treated with PORTICO (n = 344) for each patient treated with ACURATE neo (n = 344). Results: In-hospital complications were comparable between both valves, including any kind of stroke (ACURATE neo = 3.5% vs. PORTICO = 3.8%; p = 1.0), major vascular complications (ACURATE neo = 4.5% vs. PORTICO = 5.4%; p = 0.99) or life-threatening bleeding (ACURATE neo = 1% vs. PORTICO = 2%; p = 0.68). The rate of device failure defined by the VARC-2 criteria were comparable, including elevated gradients and moderate-to-severe paravalvular leakage (ACURATE neo = 7.3% vs. PORTICO = 7.6%; p = 1.0). However, the need for permanent pacemaker implantation (PPI) was significantly more frequent after the use of PORTICO THV (9.5% vs. 18.7%; p = 0.002). Conclusions: In this two-center case-matched comparison, short-term clinical and hemodynamic outcomes showed comparable results between PORTICO and ACURATE neo prostheses. However, PORTICO was associated with a significant higher incidence of PPI.

Generational Differences in Outcomes of Self-Expanding Valves for Transcatheter Aortic Valve Replacement.

The Medtronic Evolut Pro valve (EPV) is a new-generation self-expanding valve (SEV), particularly designed to reduce paravalvular leak (PVL) rates in transcatheter aortic valve replacement (TAVR). We aimed to compare the safety and efficacy of EPV with older-generation SEVs, in particular, postprocedural PVL and permanent pacemaker (PPM) implantation rates. We performed a retrospective, multicenter, propensity-matched analysis of the Israeli TAVR registry between September 2008 and June 2019. Two independent propensity score-matched comparisons were performed comparing EPV with the first-generation CoreValve (CV), and comparing EPV with the second-generation Evolut R valve (ERV). The registry included 2591 patients who were propensity-matched into 3 cohorts: EPV (n = 222), CV (n = 212), and ERV (n = 213). Moderate and above PVL rates were lower for EPV (angiographic PVL [aPVL], 0.6%; echocardiographic PVL [ePVL], 3.0%) as compared with CV (aPVL, 7.8% [P<.001] and ePVL, 11.6% [P<.01]), but not as compared with ERV (aPVL, 6.4% [P<.01] and ePVL, 4.4% [P=.57]). Lower rates of PPM were noted for EPV (16.3%) as compared with both CV (33.5%; P<.001) and ERV (24.4%; hazard ratio, 0.61; 95% confidence interval, 0.37-0.995; P=.046). Other safety and efficacy outcome rates were excellent, with significant improvements as compared with older-generation SEVs. The EPV demonstrates excellent procedural safety and efficacy outcomes. Moderate and above PVL rates were significantly reduced in comparison with CV; however, not significantly reduced as compared with ERV. The need for PPM implantation was lower as compared with both older-generation valves.

Incidence and Risk Assessment of Infolding Using Self-Expandable Devices in TAVR

BackgroundTranscatheter aortic valve replacement is an evolving interventional therapy for patients with symptomatic severe aortic stenosis. Infolding (INF) as wrinkling along the valve frame is only seen in self-expandable transcatheter valves or surgical sutureless prostheses and is known to be a very rare event during delivery but probably underreported. Therefore, we aimed to (1) determine the frequency of events, (2) identify potential predictors of INF, and (3) evaluate the potential clinical impact of this adverse event. MethodsINF cases of 2 centers were retrospectively analyzed in an all-comer cohort of 1416 patients with older- and newer-generation self-expandable (SEV) devices. The underlying functional, anatomical, and procedural conditions were evaluated by univariate analysis. ResultsINF+ was observed in 14 patients (1.0%) with the following valve size distribution: SEV-26: 14.3%, SEV-29: 28.6%, and SEV-34: 57.4%. Several dependent predictors of INF were pointed out, such as severe peripheral kinking, severe aortic calcification, resheathing maneuvers, valve-in-valve procedures, and the use of the largest valve size. INF+ patients showed a higher incidence of acute kidney injury (INF− vs. INF+: 12.3% vs. 35.7%; p = 0.008), of a new atrioventricular block (INF− vs. INF+: 14.8% vs. 42.9%; p = 0.003), and a higher need of permanent pacemaker implantation (INF− vs. INF+: 14.9% vs. 35.7%; p = 0.031). ConclusionsIdentifying potential predictors of INF can probably influence the implantation strategy and improve safety algorithms and clinical outcomes. Even being a rare but potentially life-threatening and underreported event, safety rules must be established when expanding transcatheter aortic valve replacement treatment to younger patients.

Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut

BackgroundDirect comparisons of latest-generation balloon-expandable versus self-expanding transcatheter heart valves (THV) are scarce. To compare outcomes after transcatheter aortic valve replacement (TAVR) with SAPIEN 3 Ultra (Ultra) versus Evolut R or Pro (Evolut) THVs. Methods1612 consecutive patients undergoing TAVR with either Ultra (n = 616) or Evolut (n = 996) were included. After propensity score matching (PSM), 467 and 205 matched pairs were identified in the entire cohort and with latest-generation THVs, respectively. Outcomes were investigated up to 30 days after TAVR. ResultsAfter PSM, baseline characteristics were comparable in the entire cohort (n = 934). Device success (92.7% vs. 87.6%; p = 0.011) and need for permanent pacemaker implantation (PPI) (15.2% vs. 8.4%; p = 0.002) were higher for Evolut compared with Ultra. Elevated gradients (≥20 mm Hg) were less frequent (1.6% vs. 10.4%; p < 0.001), whereas rates of ≥ moderate paravalvular leakage (PVL II+) were more frequent for Evolut compared with Ultra (3.7% vs. 1.3%; p = 0.019).With latest-generation THVs (n = 410), device success was comparable (93.2% vs. 89.8%; p = 0.216), whereas the need for PPI was higher for Evolut Pro compared with Ultra (15.6% vs. 9.8%; p = 0.075). Elevated gradients were less frequent (0% vs. 8%; p < 0.001), whereas rates of PVL II+ were more frequent for Evolut compared with Ultra (5.4% vs. 1.5%; p = 0.028). ConclusionsDevice success rates were high with both THV platforms with low rates of adverse events up to 30 days after TAVR. Compared with Ultra, Evolut was associated with higher pacemaker rates as well as PVL II+, but with less elevated gradients.