Rate Of Permanent Pacemaker Implantation Research Articles

Rates of Permanent Pacemaker Implantation in the Elderly in a State-wide Australian Cohort From 2009–2018

Permanent pacemaker implantation (PPI) has become standard of care for significant bradyarrhythmia since the early 1960s. Understanding pacemaker utilisation and projection in our ageing populations has important implications for medical resource utilisation.

R17 Predictors of Pacemaker Insertion Post-Sutureless (Perceval) Aortic Valve Implantation

The use of rapid deployment sutureless aortic valve replacement (AVR) has become a viable alternative to conventional AVR especially in intermediate risk and high-risk patients. However, such has been associated with increased rates of permanent pacemaker (PPM) implantation compared to conventional AVR. The aim of this study was to determine predictive factors for complete heart block requiring insertion of a PPM post-AVR with a Perceval S valve.

Small balloon strategy associated with low pacemaker implantation rate after self-expanding transcatheter valve implantation.

This study aims to investigate whether small balloon aortic valvuloplasty (BAV) reduces the need for permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI). This was a retrospective analysis using data from our local TAVI database. Small BAV was defined as a small balloon size (=18 mm) pre-dilatation. Normal BAV was defined as a balloon size >18 mm. The primary endpoint was the incidence of new PPMI. Of 99 consecutive TAVI patients, five patients were excluded due to pre-existing permanent pacemaker. Patients in the small BAV group (n=57) had a significantly lower PPMI rate compared with the normal BAV group (n=37) (3.5% vs. 18.9%, P=0.026). Moderate or severe aortic valve regurgitation post-procedure was similar between the small BAV and normal BAV groups (5.3% vs. 8.1%, P=0.480); likewise, the mean aortic gradient post-procedure did not differ significantly (11.5±5.2 mmHg vs. 12.2±7.3 mmHg, 1 mmHg=0.133 kPa, P=0.580) between the groups. Device success rates were also similar (94.7% vs. 91.8%, P=0.680). In multivariable analysis, small BAV (P=0.027), the ratio of prosthesis diameter to annulus diameter (P=0.048), and mean aortic gradient by echo in the basement (P=0.021) were independent predictors of PPMI. The small BAV strategy is associated with a low rate of permanent pacemaker implantation after transcatheter self-expanding valve implantation in this single-center observational study.

Short-Term Outcomes of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Kidney Transplant Recipients (from the US Nationwide Representative Study)

Kidney transplant recipients (KTRs) are considered high-risk patients for surgical interventions. Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS) at high operative risk. However, the outcomes of TAVI compared with SAVR KTRs have not been well-studied in nationally representative data. Patients with prior history of functioning kidney transplant who were hospitalized for TAVI and SAVR between January 2012 and December 2017 were identified retrospectively in the Nationwide Readmissions Database. Our study included 762 TAVI and 1,278 SAVR KTRs. Compared with SAVR, TAVI patients generally had higher rates of co-morbidities with lower risk of in-hospital mortality (3.1% vs 6.3, p = 0.002), blood transfusion (11.5% vs 38.6%, p <0.001), acute myocardial infarction (3.9% vs 6.5%, p = 0.16), acute kidney injury (24.5% vs 42.1%, p <0.001), sepsis (3.9% vs 9.5%, p <0.001) and discharge with disability (42.6% vs 68.4%, p <0.001). However, the rate of permanent pacemaker implantation was significantly higher in TAVI group (11.4% vs 3.9%, p <0.001). Of note, in-hospital stroke and 30-day readmission were comparable between both groups. These findings were confirmed after adjusting for other co-morbidities. TAVI is growing as a valid and safe alternative for KTRs with severe AS.

Transcatheter aortic valve replacement after chest radiation: A propensity-matched analysis

BackgroundChest radiation therapy (CRT) for malignant thoracic neoplasms is associated with development of valvular heart disease years later. As previous radiation exposure can complicate surgical treatment, transcatheter aortic valve replacement (TAVR) has emerged as an alternative. However, outcomes data are lacking for TAVR patients with a history of CRT. MethodsWe conducted a retrospective study of all patients who underwent a TAVR procedure at a single institution between September 2012 and November 2018. Among 1341 total patients, 50 had previous CRT. These were propensity-matched in a 1:2 ratio to 100 patients without history of CRT. Thirty-day adverse events were analyzed with generalized estimating equation models. Overall mortality was analyzed with stratified Cox regression modelling. ResultsMedian clinical follow-up was 24 months (interquartile range [IQR], 12–44 months). There was no difference between CRT and non-CRT patients in overall mortality (hazard ratio [HR] 0.84 [0.37–1.90], P = 0.67), 30-day mortality (HR 3.1 [0.49–20.03], P = 0.23), or 30-day readmission rate (HR 1.0 [0.43–2.31], P = 1). There were no differences in the rates of most adverse events, but patients with CRT history had higher rates of postprocedural respiratory failure (HR 3.63 [1.32–10.02], P = 0.01) and permanent pacemaker implantation (HR 2.84 [1.15–7.01], P = 0.02). ConclusionsFor patients with aortic valve stenosis and previous CRT, TAVR is safe and effective, with outcomes similar to those in the general aortic stenosis population. Patients with history of CRT are more likely to have postprocedural respiratory failure and to require permanent pacemaker implantation.

Predictors of Pacemaker Insertion Post-Sutureless (Perceval) Aortic Valve Implantation

The use of rapid deployment sutureless aortic valve replacement (AVR) has become a viable alternative to conventional AVR especially in intermediate and high-risk patients. However, sutureless AVR has been associated with increased rates of permanent pacemaker (PPM) implantation compared with conventionally implanted aortic valve prostheses. The aim of this study was to determine predictive factors for complete heart block requiring insertion of a PPM post-AVR with a Perceval S sutureless valve (LivaNova, London, UK). Such knowledge will help to improve patient counselling, selection and management of patients undergoing sutureless AVR. A retrospective cohort study assessed all patients who underwent insertion of the Perceval sutureless aortic valve prosthesis between July 2015 and September 2019. Medical records were reviewed for demographic, preoperative electrocardiograph (ECG), and operative features related to postoperative PPM implantation and follow-up in the electrophysiology clinic. One hundred and thirty (130) patients without pre-existing PPM underwent sutureless AVR (66.9% male, average age 74.4±6.6 years). Fifty-seven (57) underwent concomitant cardiac surgical procedures. Eight (8) patients underwent redo cardiac surgery. Nineteen (19) of the 130 (14.6%) patients required insertion of a PPM during their postoperative course. Factors associated with PPM insertion were right bundle branch block (overall n=15, PPM vs No PPM: 8/19 vs 7/111 [42.1 % vs. 6.31 %; p<0.01]), longer QRS duration 113.32ms±22.24 ms vs 100.52±20.96 ms (p=0.017) and longer PR Interval 185.166±42.38 ms vs 169.23±25.70 ms (p=0.03). Insertion of rapid deployment sutureless aortic valves in the setting of pre-existing right bundle branch block, prolonged QRS complex and longer PR intervals is associated with increased risk of postoperative PPM requirement. These factors should be considered when preoperatively counselling and postoperatively managing patients when balloon expandable sutureless valves are used.

Rapid Deployment Valves in Aortic Valve Replacement: Is Brevity the Soul of It?

In this issue of The Annals of Thoracic Surgery, Wiedemann and colleagues1 from Vienna, Austria, present their clinical experience with anterior right thoracotomy and the Intuity (Edwards Lifesciences) rapid deployment aortic valve (RDV).1 In their single-institution, nonrandomized group of patients, the authors demonstrate commendable results with an inhospital mortality of 0.6%, a 10.3% rate of permanent pacemaker implantation, and nearly 90% of patients without any paravalvular regurgitation at 11 months’ median follow-up.

Predictors of pacemaker implantation after transcatheter aortic valve implantation according to kind of prosthesis and risk profile: a systematic review and contemporary meta-analysis.

Permanent pacemaker implantation (PPI) may be required after transcatheter aortic valve implantation (TAVI). Evidence on PPI prediction has largely been gathered from high-risk patients receiving first-generation valve implants. We undertook a meta-analysis of the existing literature to examine the incidence and predictors of PPI after TAVI according to generation of valve, valve type, and surgical risk. We made a systematic literature search for studies with ≥100 patients reporting the incidence and adjusted predictors of PPI after TAVI. Subgroup analyses examined these features according to generation of valve, specific valve type, and surgical risk. We obtained data from 43 studies, encompassing 29 113 patients. Permanent pacemaker implantation rates ranged from 6.7% to 39.2% in individual studies with a pooled incidence of 19% (95% CI 16-21). Independent predictors for PPI were age [odds ratio (OR) 1.05, 95% confidence interval (CI) 1.01-1.09], left bundle branch block (LBBB) (OR 1.45, 95% CI 1.12-1.77), right bundle branch block (RBBB) (OR 4.15, 95% CI 3.23-4.88), implantation depth (OR 1.18, 95% CI 1.11-1.26), and self-expanding valve prosthesis (OR 2.99, 95% CI 1.39-4.59). Among subgroups analysed according to valve type, valve generation and surgical risk, independent predictors were RBBB, self-expanding valve type, first-degree atrioventricular block, and implantation depth. The principle independent predictors for PPI following TAVI are age, RBBB, LBBB, self-expanding valve type, and valve implantation depth. These characteristics should be taken into account in pre-procedural assessment to reduce PPI rates. PROSPERO ID CRD42020164043.

Early commercial experience with a newly designed balloon-expandable transcatheter heart valve: 30-day outcomes and implications of preprocedural computed tomography.

We herein report a single-centre experience with the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve implantation (TAVI) system. Between March 2019 and January 2020, a total of 79 consecutive patients received transfemoral TAVI using the SAPIEN 3 Ultra device. Data were retrospectively analysed according to updated Valve Academic Research Consortium-2 definitions. Detailed analysis of multislice computed tomography data was conducted to identify potential predictors for permanent pacemaker (PPM) implantation and residual paravalvular leakage (PVL) post TAVI. Device success and early safety were 97.5% (77/79) and 94.9% (75/79) with resulting transvalvular peak/mean pressure gradients of 21.1 ± 8.2/10.9 ± 4.4 and PVL >mild in 0/79 patients (0%). Mild PVL was seen in 18.9% (15/79) of cases. Thirty-day mortality was 2.5% (2/79). The Valve Academic Research Consortium-2 adjudicated clinical end points disabling stroke, acute kidney injury and myocardial infarction occurred in 1.3% (1/79), 5.1% (4/79) and 0% (0/79) of patients. Postprocedural PPM implantation was necessary in 7.6% (6/79) of patients. Multislice computed tomography analysis revealed significantly higher calcium amounts of the right coronary cusp in patients in need for postprocedural PPM implantation and a higher eccentricity index in patients with postinterventional mild PVL. First experience with this newly designed balloon-expandable-transcatheter heart valve demonstrates adequate 30-day outcomes and haemodynamic results with low mortality, low rates of PPM implantation and no residual PVL >mild. The herein-presented multislice computed tomography values with an elevated risk for PPM implantation and residual mild PVL may help to further improve outcomes with this particular transcatheter heart valve in TAVI procedures.

Abstract 17148: Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis: Two-Year Results From the LRT Trial

Objective: To evaluate clinical outcomes and transcatheter heart valve hemodynamics at 2 years after transcatheter aortic valve replacement (TAVR) in low-risk patients. Background: Early results from the Low Risk TAVR (LRT) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis (AS) who are low surgical risk. Methods: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 2 years. Results: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and a low permanent pacemaker implantation rate. At 2-year follow-up, mortality was 4.4%, stroke rate was 4.6%, and permanent pacemaker implantation rate was 9.0%. Four patients (2.3%) presented with endocarditis; two of these underwent surgical reintervention. Of the 14% of TAVR subjects who had evidence of subclinical leaflet thrombosis at 30 days, there was no impact on valve hemodynamics at 2 years or stroke rate (4.8%) versus 4.2% in patients who did not have leaflet thickening. Conclusions: TAVR in low-risk patients with symptomatic severe AS remains safe at 2 years. Subclinical leaflet thrombosis, observed in a minority of TAVR patients at 30 days, did not impact valve hemodynamics in the longer term.

Abstract 12997: Impact of Baseline Atrial Fibrillation/Flutter on Short- and Long-term Outcomes After Transcatheter Aortic Valve Replacement With Sapien-3 Valve

Introduction: Pre-existing atrial fibrillation has been linked with poor outcomes among patients undergoing transcatheter aortic valve replacement (TAVR). Objective: We sought to study the impact of baseline atrial fibrillation/flutter (AF) on outcomes after TAVR with SAPIEN-3 (S3) valve. Methods: All consecutive patients with severe symptomatic aortic stenosis who underwent TAVR with S3 valve at the Cleveland Clinic between April 2015 and December 2018 were included. Results: We included 1028 consecutive patients. Overall, the mean age of our study population was 81 ± 8.9 years, 58.8% were males, 95.8% were Caucasians. Pre-existing AF was present in 432 patients (42%). STS risk score was higher with AF compared to no AF (6.7 ± 3.8% vs. 5.4 ± 3.4%; p &lt; 0.001). Baseline left ventricular ejection fraction (LVEF) was lower with AF (54% vs. 58%; p &lt; 0.001). The rates of 30-day permanent pacemaker (PPM) implantation were similar between AF and no AF (11.4% vs. 9.4%; p = 0.326), as were the rates of new-onset left bundle branch block (LBBB) at discharge (9.6% vs. 9.4%; p = 0.901). There was also no difference in stroke rates at 30 days between the 2 groups (1.6% vs. 1%; p = 0.385). Post-TAVR mild or greater aortic regurgitation (AR) was higher with AF compared to no AF (21.5% vs. 16%; p = 0.022). LVEF was lower with AF at both 30 days (56% vs. 58.5%; p &lt; 0.001) and 1 year (56% vs. 59%; p &lt; 0.001). However, the change in LVEF (Δ) after TAVR was similar between AF and no AF (+1.1% vs. +1.4%; p = 0.624). At 2 years, all-cause death was higher with AF (22.9% vs. 12.8%; log-rank p = 0.011). There was no mortality difference between persistent versus paroxysmal AF (log-rank p = 0.714). Conclusions: Among our S3 TAVR patients, AF did not affect PPM, new-onset LBBB or stroke rates after the procedure. AF was associated with higher mild or greater AR at 30 days, as well as lower LVEF at both 30 days and 1 year compared to no AF. There was significantly higher all-cause mortality in the AF group at 2 years after TAVR.

Overcoming the transcatheter aortic valve replacement Achilles heel: conduction abnormalities-a systematic review.

Transcatheter aortic valve replacement (TAVR) has been shown to be a good alternative to surgery for treating severe symptomatic aortic stenosis (AS) across the whole range of surgical risk patients. Whereas most periprocedural TAVR complications have significantly decreased over time, conduction disturbances remain high. Approaches to decrease this shortcoming are under continuous investigation. We conducted a systematic review focusing on modifiable factors impacting post-TAVR conduction disturbances, such as balloon aortic valvuloplasty (BAV), type of new-generation transcatheter valve and implantation depth (ID). Search strategies were based on the best available evidence from each study. Primary endpoints were post-TAVR need of permanent pacemaker implantation (PPI) and new onset left bundle branch block (NOLBBB). Data from 35 studies with a total of 29,982 patients were analyzed. BAV did not negatively impact PPI rates after TAVR. In propensity-matched and randomized trials, the Evolut R valve was associated with higher rates of PPI compared to the Sapien 3 valve (25% vs. 19.2% in propensity-matched studies; 22.9% vs. 19% in a randomized trial). The Acurate Neo valve was associated with the lowest PPI rate in observational studies (10.4%), but a PPI rate similar to Sapien 3 was reported in a randomized trial (10% vs. 9%). The Portico valve system was associated with a higher PPI risk (PPI rate of 21.9% and 27.7% in propensity-matched and randomized studies, respectively). ID and its relation with the membranous septum (MS) length predicted post-TAVR conduction disturbances, particularly with Evolut R and Sapien 3 valves. Pre-TAVR BAV did not increase the risk of conduction disturbances post-TAVR. Among the new-generation transcatheter valve systems, Sapien 3 and Acurate Neo valves were associated with the lowest PPI rates followed by the Evolut and Portico valves. A deeper valve implantation and a shorter MS length determined an increased risk of conduction disturbances post-TAVR.

Rates of permanent pacemaker implantation for complete heart block complicating pregnancy: a nationwide analysis of 20,451,108 pregnant patients in the USA

Abstract Introduction Complete heart block (CHB), also known as third-degree heart block, occurs when there is complete dissociation of the atria and ventricles. CHB during pregnancy is extremely rare and one possible mechanism may be related to the stretching of the atria during pregnancy causing conduction defects Purpose There is limited data on the rates of CHB and pacemaker (PPM) use in pregnant patients, with only a few case reports published. In this study we sought to define the rates of permanent pacemaker implantation for CHB complicating pregnancy. Methods The Nationwide Inpatient Sample was queried from 2010 to 2014 using the International Classification of Diseases, 9th revision diagnosis codes for pregnancy and CHB and procedure codes for PPM in any procedure field for patients 18 years or older. Results From 2010 to 2014, we identified 20,451,108 pregnancies in patients above the age of 18 years. The overall rates of CHB were 643 (0.0031%). The sample consisted of 643 patients (Mage= 29.28±6.42 years) with CHB, the majority of whom were Caucasians 328 (51%). Average length of stay (LOS) (M ± SD) was 4.94±7.859 and total hospitalization charges were 51,715.04±112,345.98 ($). Moreover, the occurrence of other conditions which could lead to the development of CHB was: sarcoidosis 0 (0%), systemic lupus erythematosus 5 (0.8%), prior myocardial infarction 25 (3.8%), Lyme disease 0 (0%). Among patients with CHB, PPM implantation was done in 60 (9.3%), and TVP were 5 (0.8%). The overall composite mortality rates were 21 (3.2%). On comparing the non-PPM group to the PPM group, rates of in-hospital mortality were 3.6% vs 0%; p=0.059, LOS were 4.49±5.01 vs 12.50±15.35; p&amp;lt;0.001, complications such as congestive heart failure 0% vs 8.4%; p&amp;lt;0.001, cardiogenic shock 1% vs 8.4%; p&amp;lt;0.001, respiratory failure needing mechanical ventilation 1.7% vs 0; p&amp;lt;0.04, sudden cardiac death 3.4% vs 0; p&amp;lt;0.05. Conclusions The overall rates of CHB were 3.1 in 100,000 pregnancies. There were no reported in-hospital deaths among pregnant patients with CHB who received PPM and TVP. Relatively lower rates of PPM implantation in these patients might indicate that CHB during pregnancy is less severe and patients may have a stable narrow complex junctional escape rhythm. PPM implantation is recommended for those who are symptomatic or have a slow wide QRS complex rhythm indicating a block below the bundle of His.With this study we attempt to better define the occurrence of CHB during pregnancy, which could lead to better understanding and management of this condition. Funding Acknowledgement Type of funding source: None

Pacemaker implantation after balloon- or self-expandable transcatheter aortic valve replacement in patients with aortic stenosis

Abstract Background The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with different devices available in recent years remains a matter of debate. Methods Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. Results A total of 49,201 patients with aortic stenosis treated with transcatheter aortic valve replacement (TAVR) using the balloon-expandable (BE) Edwards SAPIEN valve or the self-expanding (SE) Medtronic CoreValve were found in the database. Patients treated with early BE or SE valves had higher Charlson comorbidity and frailty indexes than those treated with later BE or SE valves, and slightly higher EuroSCORE II. Patients treated with SE valves had higher rates of previous pacemaker or defibrillator than those treated with BE valves. Mean (SD) follow-up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1–2.0] years). PPI after the procedure was reported in 13,289 patients, among whom 11,010 (22.4%) had implantation during the first 30 days (figure 1). In multivariable analysis, using early BE TAVR as reference, adjusted OR (95% CI) for PPI during the first 30 days was 0.88 (0.81–0.95) for latest BE TAVR, 1.40 (1.27–1.55) for early SE TAVR and 1.17 (1.07–1.27) for latest SE TAVR. Compared to early BE TAVR, adjusted HR for PPI during the whole follow-up was 1.01 (0.95–1.08) for latest BE TAVR, 1.30 (1.21–1.40) for early SE TAVR and 1.25 (1.18–1.34) for latest SE TAVR. Conclusion In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. However, this was less apparent than previously reported in this large analysis of unselected patients seen in “real life” practice. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow-up. Funding Acknowledgement Type of funding source: None

Prevalence and prognostic impact of left ventricular outflow tract calcification in patients with severe aortic stenosis undergoing transfemoral TAVI using second-generation devices

Abstract Introduction Left ventricular outflow tract (LVOT) calcification is known to be associated with adverse outcomes after TAVI in patients receiving first-generation transcatheter heart valves (THV). Second-generation THV have been shown to improve outcomes of TAVI patients. Thus, aim of this study is to assess the prevalence of LVOT calcification as well as its impact on procedural and clinical outcomes in patients with severe aortic stenosis undergoing transfemoral TAVI with second-generation THV in a real-world patient cohort. Methods In this retrospective single-center analysis patients receiving transfemoral TAVI with second-generation THV for the treatment of aortic stenosis (AS) between 05/2012 and 06/2018 and with adequate CT data were included (n=836). Amount of LVOT calcification was measured quantitatively from contrast-enhanced multislice CT using a dedicated software. Baseline characteristics and outcomes were compared according to presence of significant LVOT calcification (none/≤10 mm3 vs. &amp;gt;10 mm3). Procedural and clinical outcome were assessed in accordance with VARC-2 criteria. All-cause mortality was assessed by Kaplan-Meier method, median follow-up was 1.4 years. Results Significant LVOT calcification was present in 37.0% of patients. Patients with LVOT calcification were older (all results as follows without (w/o) vs. with (w) LVOT calcification: 81.4 (77.1, 84.8) vs. 82.3 (78.0, 86.3) years, p=0.006), but presented similar STS scores compared to those without LVOT calcification (5.4±4.7 vs. 5.4±3.5%, p=0.94). Moreover, patients with LVOT calcification had higher mean transvalvular gradients at baseline (30.0 (21.0, 41.0) vs. 37.0 (25.7, 47.0) mmHg, p&amp;lt;0.001) and higher aortic valve calcium volume (380.7 (226.8, 632.1) vs. 663.6 (364.5, 1070.3) mm3, p&amp;lt;0.001). There were no significant differences in rate of device success (97.0 vs. 94.2%, p=0.11), renal failure (2.6 vs. 2.3%, p=1.00), myocardial infarction (0.9 vs. 1.2%, p=1.00) or rate of permanent pacemaker implantation at 30 days after TAVI (16.6 vs. 17.2%, p=0.91). However, rate of TIA/stroke was significantly higher in patients with LVOT calcification (2.1 vs. 6.2%, p=0.0098). Furthermore, patients with LVOT calcification had a higher rate of more than mild paravalvular leakage at discharge (3.8 vs. 7.6%, p=0.033). Rate of 1 year all-cause mortality (17.8 vs. 21.2%, p=0.23) was not significantly different between both groups. Conclusions Significant LVOT calcification is present in a substantial proportion of patients receiving TAVI. In such patients, higher rates of cerebrovascular events and more than mild PVL occurred compared to those without significant LVOT calcification even with currently available second-generation THV. Although these findings did not translate into higher mortality rates in the present study, they underline the need for further optimization of THV technology in order to improve outcomes among all TAVI patients. Figure 1. 1-year mortality Funding Acknowledgement Type of funding source: None

Is alcohol septal ablation in women performed too late?

Abstract Introduction Alcohol septal ablation (PTSMA) was introduced as interventional alternative to surgical myectomy for symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) 25 years ago. As gender differences in diagnosis and treatment of HOCM are still unclear we analyzed baseline characteristics and results of PTSMA in a large single center cohort with respect to gender. Methods and results Between 05/2000 and 06/2017 first PTSMA in our center was performed in 952 patients with symptomatic HOCM. We treated less 388 (40.8%) women and 564 (59.2%) men. All patients underwent clinical follow-up. At the time of the intervention women were older (61.2±14.9 vs. 51.9±13.7 years; p&amp;lt;0.0001) and suffered more often from NYHA grade III/IV dyspnea (80.9% vs. 68.1%; p&amp;lt;0.0001), whereas angina pectoris was comparable in women (62.4%) and men (59.9%). Echocardiographic baseline gradients were comparable in women (rest 65.0±38.1 mmHg and Valsalva 106.2±45.7 mmHg) and men (rest 63.1±38.3 mmHg and Valsalva 103.6±42.8 mmHg). But, women had smaller diameters of the left atrium (44.3±6.9 vs. 47.2±6.5 mm; p&amp;lt;0001), maximal septum thickness (20.4±3.9 vs. 21.4±4.5 mm; p&amp;lt;0.01), and maximal thickness of the left ventricular posterior wall (12.7±2.8 vs. 13.5±2.9 mm; p&amp;lt;0.0001). In women, more septal branches (1.3±0.6 vs. 1.2±0.5; p&amp;lt;0.05) had to be tested to identify the target septal branch. The amount of injected alcohol was comparable (2.0±0, 4 in women vs. 2.1±0.4 ml in men). The maximum CK increase was lower in women (826.0±489.6 vs. 903.4±543.0 U / l; p&amp;lt;0.05). During hospital stay one woman and one man died, each (n.s.). The frequency of total AV blocks in the cathlab showed no significant difference between women (41.5%) and men (38.3%). Furthermore, the rate of permanent pacemaker implantation during hospital stay did not differ (12.1% in women vs. 9.4% in men). Follow-up periods of all patients showed no significant difference between women (5.7±4.9 years) and men (6.2±5.0 years). Overall, 37 (9.5%) women died during this period compared to only 33 (5.9%) men (p&amp;lt;0.05). But, cardiovascular causes of death were not significantly different between women (2.8%) and men (1.6%). Furthermore, the rates of surgical myectomy after failed PTSMA (1.3% in women vs. 2.3% in men), ICD implantation for primary prevention of sudden cardiac death according to current guidelines (4.1% in women vs. 5.9% in men) or pacemaker implantation (3.6% in women vs. 2.0% in men) showed no significant differences. Summary PTSMA in women with HOCM was performed at more advanced age with more pronounced symptoms compared to men. While there were no differences in acute outcomes, overall long-term mortality was higher in women without differences in cardiovascular mortality. Therefore, women may require more intensive diagnostic approaches in order not to miss the correct time for gradient reduction treatment. Funding Acknowledgement Type of funding source: None

Impact of tapered-shaped left ventricular outflow tract on permanent pacemaker implantation after the third-generation balloon-expandable valve implantation

Abstract Background In the era of transcatheter aortic valve implantation (TAVI) for patients with lower surgical risk, conduction disturbances requiring permanent pacemaker implantation (PPI) after TAVI remain a serious concern. The association between tapered-shaped left ventricular outflow tract (LVOT) and PPI after TAVI has not been elucidated. Purposes This study sought to identify predictors for PPI after TAVI with the third-generation balloon-expandable valve, with focus on LVOT morphology. Methods Of 272 consecutive patients treated with the third-generation balloon-expandable valve, 256 patients without previous PPI or bicuspid valve were retrospectively analyzed. Results PPI was implanted after TAVI in 20 (7.8%) patients. Patients requiring PPI had smaller LVOT area (356.3 mm2 vs. 399.4 mm2, p=0.011). Moreover, receiver-operating characteristic (ROC) statistics showed that LVOT area /annulus area possessed significantly higher predictive ability than LVOT area (area under the curve: 0.91 [95% confidence interval [CI]: 0.84 to 0.95] vs. 0.67 [95% CI: 0.57 to 0.77], p&amp;lt;0.001). Multivariable analysis revealed LVOT area /annulus area (odds ratio [OR]: 1.93 [95% CI: 1.38–2.71]; p&amp;lt;0.001 per % of decreasing), the difference between membranous septum length and implantation depth (ΔMSID) (OR: 6.82 [95% CI 2.39–19.48]; p&amp;lt;0.001 per mm of decreasing) and pre-existing complete right bundle branch block (CRBBB) (OR: 32.38 [95% CI 2.30–455.63]; p=0.002) as independent predictors of PPI. Further analysis using ROC statistics revealed LVOT area / annulus area of 88.5% and ΔMSID of 1.8 mm as the optimal cutoff points for prediction of PPI after the third-generation balloon-expandable valve implantation, with high negative predictive values of 98.1% and 99.0%, respectively. Figure shows the PPI rates stratified by the number of following predictors: LVOT area /annulus area &amp;lt;88.5%, ΔMSID &amp;lt;1.8 mm and pre-existing CRBBB. Patients with 2 or more predictors had significantly higher PPI rates than those with 1 or less predictor (67% [18 of 27 patients] vs. 1% [2 of 229 patients], p&amp;lt;0.001). Conclusions LVOT area /annulus area, ΔMSID and pre-existing CRBBB were identified as powerful independent predictors for PPI after TAVI. Higher valve implantation is important to prevent excessive PPI especially for patients with pre-procedural tapered-shaped LVOT, short membranous septum or pre-existing CRBBB. PPI rates stratified by predictors Funding Acknowledgement Type of funding source: None

Procedural and clinical outcomes of type 0 versus type 1 bicuspid aortic valve stenosis treated with transcatheter valve replacement: insights from the BEAT international collaborative registry

Abstract Background Transcatheter aortic valve replacement (TAVR) is an established therapy for symptomatic severe aortic stenosis. Bicuspid aortic valves (BAV) were generally excluded from randomized trials due to anatomic features that may challenge TAVR (valve morphology, annulus geometry and size and severe calcifications). Nevertheless real-world registries have shown that a consistent number of BAV has been treated with TAVR. Whether BAV phenotype may affect acute or long-term outcomes following TAVR still remains unclear. Purpose Evaluate the impact of BAV phenotype on procedural and clinical outcomes after TAVR with new generation valves. Methods Patients included in the BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry were classified according to the BAV phenotype. Procedural and clinical outcomes of type 0 (2 cusps, 1 commissure, no raphe) vs type 1 (1 raphe) BAV are here reported. Primary endpoint was post-procedural device success, according to Valve Academic Research Consortium–2 (VARC-2) criteria. Secondary endpoints included procedural complications, rate of permanent pacemaker (PM) implantation and assessment of clinical outcomes at 30-day and 1-year follow-up. Results BAV 0 phenotype was present in 25 (7.1%) cases, and BAV 1 in 218 (61.8%). 3 (0.9%) patients with BAV 2 phenotype and 105 (29.8%) patients in whom BAV phenotype was undeterminable were excluded. Baseline characteristics of the two populations were well balanced. Mean STS score tended to be lower in type 0 vs type 1 BAV (3.35% ±1.8 vs 4.5% ± 3.0, p=0.062). Mean transvalvular gradient, aortic valve area (AVA), and left ventricular ejection fraction didn't differ between groups. According to CT findings moderate-severe aortic valve calcifications were less frequently present in type 0 vs type 1 (52% vs 71.1%, p=0.01). TAVR was performed under conscious sedation in most patients (89.7%), no differences were noted in terms of valve type, valve size, pre and postdilation between groups. There was no significant difference in any peri-procedural complication including pericardial tamponade, second valve implantation, valve embolization, annular rupture, aortic dissection, coronary occlusion, conversion to open surgery, and need of PM between groups however VARC-2 success tended to be lower in type 0 BAV versus type 1 (72% vs 86.7%; p=0.07). A higher rate of mean transvalvular gradient&amp;gt;20 mmHg was observed in the type 0 vs type 1 groups (respectively 24% vs 6%, p=0.007), while no differences were reported in the rate of moderate-severe aortic regurgitation. At 30-day and 1-year follow-up we did not find differences in clinical outcomes. Conclusions Our study confirms the feasibility of TAVR in both type 0 and type 1 BAV, however despite a lower rate of moderate-severe calcifications, a trend toward a lower VARC device success and a higher rate of mean transvalvular gradient &amp;gt;20 mmHg was observed in type 0 vs type 1 BAV. Funding Acknowledgement Type of funding source: None

Predictors for permanent pacemaker implantation following transcatheter aortic valve implantation: trends over the past decade.

This study sought to identify risk factors for permanent pacemaker implantation (PPMI) after Transcatheter aortic valve implantation (TAVI) and explain their trends over the last decade. TAVI is performed nowadays for severe aortic stenosis in more patients with lower surgical risk. While most TAVI complications have been reduced, PPMI remains common. In this observational, retrospective cohort analysis, 338 TAVI patients treated between 2008 and 2017 were reviewed. Risk factors were compared between the early (2008-2013) and late years (2014-2017), and a multivariable logistic regression model was used. A decreasing trend in PPMI over time was observed (p for trend = 0.008), as was a lower rate of PPMI in the late period (19.3% vs. 31.7%, p = 0.009). Three variables were identified as independent risk factors for PPMI that also decreased significantly in the late period: valve implantation depth ≥ 8mm (OR = 4.3, 95% CI 2.3-8.2, p < 0.001), use of self-expandable valves (OR = 2.8, 95% CI 1.4-5.5, p = 0.004), and patient risk assessed by EuroSCORE II (OR = 1.07, 95% CI 1.0-1.1, p = 0.034). Indications for PPMI were also shown to change over time, with an increase in the prevalence of complete AVB as the main indication for PPMI (p = 0.048), and a trend towards a decrease in LBBB alone (p = 0.061). The decrease in post-TAVI PPMI over the past decade is multifactorial and can be explained by (1) lower baseline patient surgical risk, (2) modified procedural variables including decreased implantation depth and increased use of balloon-expandable valves, and (3) refined indications for PPMI.

Procedural and clinical outcomes of type 0 versus type 1 bicuspid aortic valve stenosis undergoing trans-catheter valve replacement with new generation devices: Insight from the BEAT international collaborative registry

BackgroundAlthough bicuspid aortic valve (BAV) is not considered a “sweet spot” to trans-catheter aortic valve replacement (TAVR), a certain number of BAV underwent TAVR. Whether BAV phenotype affects outcomes following TAVR remains debated. We aimed at evaluating the impact of BAV phenotype on procedural and clinical outcomes after TAVR using new generation trans-catheter heart valves (THVs). Methodspatients included in the BEAT registry were classified according to the BAV phenotype revealed at multi-slice computed tomography (MSCT) in type 0 (no raphe) vs. type 1 (1 raphe). Primary end-point was Valve Academic Research Consortium–2 (VARC-2) device success. Secondary end-points included procedural complications, rate of permanent pacemaker implantation, clinical outcomes at 30-day and 1-year. ResultsType 0 BAV was present in 25(7.1%) cases, type 1 in 218(61.8%). Baseline characteristics were well balanced between groups. Moderate-severe aortic valve calcifications at MSCT were less frequently present in type 0 vs. type 1 (52%vs.71.1%,p = 0.05). No differences were reported for THV type, size, pre and post-dilation between groups. VARC-2 success tended to be lower in type 0 vs. type 1 BAV (72%vs86.7%;p = 0.07). Higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 group (24%vs6%,p = 0.007). No differences were reported in the rate of post-TAVR moderate-severe aortic regurgitation and clinical outcomes between groups. ConclusionsOur study confirms TAVR feasibility in both BAV types, however a trend toward a lower VARC-2 device success and a higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 BAV.