Need For Permanent Pacemaker Implantation Research Articles

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.

Bradyarrhythmias detected by extended rhythm recording in patients undergoing transcatheter aortic valve replacement (Brady-TAVR Study).

Bradyarrhythmias leading to permanent pacemaker (PPM) implantation continue to be a complication after transcatheter aortic valve replacement (TAVR). The purpose of this study was to assess the prevalence of bradyarrhythmias using an electrocardiographic (ECG) extended rhythm recording in patients pre- and post-TAVR and whether they can predict the need for PPM. This was a prospective single-center study in patients undergoing TAVR. Patients received an ECG patch for 2 weeks pre-, immediately post-, and 2-3 months post-TAVR. Caring physicians were blinded to the results of the patch except when predefined urgent arrhythmias were detected. The main outcome was the need for PPM implantation after TAVR. We enrolled 110 patients, of whom 96 underwent TAVR and were included in the final analysis. Bradyarrhythmias, defined as a pause of 3 seconds or more, occurred in 5.2%, 12.7%, and 7% of patients pre-, immediately post-, and 2-3 months post-TAVR, respectively. PPM implantation occurred in 12 patients (12.5%), of whom 9 (9.4%) underwent implantation during their index hospitalization while 3 (3.1%) required implantation postdischarge for indications other than heart block. No patients required PPM after receiving an ECG patch 2-3 months post-TAVR. Significant baseline predictors for the need for PPM included the presence of right bundle branch block and increased QRS duration. Bradyarrhythmias detected by the ECG patch did not predict the need for PPM at either the index hospitalization or the follow-up period. Bradyarrhythmias are common and can be detected with extended ECG monitoring before and after TAVR; however, in our study they did not predict the need for PPM after TAVR (ClinicalTrials.gov identifier: NCT03180073).

Ketamine for Monitored Anesthesia Care During Transcatheter Aortic Valve Replacement

PurposeTo study the feasibility and outcomes of ketamine as an anesthetic adjunct during monitored anesthesia care (MAC) in transcatheter aortic valve replacement (TAVR). DesignThis was a retrospective study. MethodsData from 155 consecutive TAVR patients at a tertiary care high-volume TAVR medical center were reviewed and analyzed. FindingsAmong the 155 TAVR cases under MAC, intravenous ketamine was administered as an adjunct in 126 patients. The most common ketamine dose was 20 mg. There was no significant difference for postoperative stroke, intraoperative conversion to general anesthesia, postoperative delirium, need for permanent pacemaker implantation, perivalvular leak and length of stay between the ketamine and non-ketamine groups. The ketamine group demonstrated a statistically significant lower 30-day mortality (P = .0381) and intraoperative cardiac arrest (P = .0025) rate when compared to the nonketamine group. ConclusionsOur results demonstrated that employing ketamine as an adjunct during MAC for TAVR is a feasible option.

628 Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve intervention: a systematic review and meta-analysis

Abstract Aims As compared with surgery, transcatheter aortic valve implantation (TAVI) is associated with increased need for permanent pacemaker implantation (PPMI). The clinical impact of PPMI post-TAVI has not been fully established. To assess by an updated meta-analysis the clinical outcomes related to PPMI after TAVI at long-term (≥12 months) follow-up (LTF). Methods and results A comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analysis was performed according to Society of Thoracic Surgeon—Predicted Risk of Mortality (STS-PROM) score. A total of 31 studies were identified, providing data on 51 069 patients. The mean duration of follow-up was 22 months. At LTF, PPMI post-TAVI was associated with a higher risk of all-cause death [22.9% vs. 19.6%; risk ratio (RR), 1.18, 95% confidence interval (CI), 1.10–1.25; P &amp;lt; 0.001] and rehospitalization for heart failure (16.6% vs. 15.1%; RR, 1.32; 95% CI, 1.13–1.52; P &amp;lt; 0.001). In contrast, risks of stroke and myocardial infarction were not affected. Among the 20 studies that reported surgical risk, the association between PPMI and LTF all-cause death risk was statistically significant only in studies enrolling patients with high STS-PROM score (RR, 1.25; 95% CI, 1.12–1.40), although there was a similar trend in those at medium and low-risk. Conclusions Patients necessitating PPMI after TAVI have higher long-term risk of all-cause death and rehospitalization for heart failure as compared to those who do not receive PPMI. Thus, strategies aimed at reducing need for PPMI might improve survival after TAVI.

Sutureless valves-are we there yet? Evidence from the PERSIST-AVR trial.

Sutur eless valves have emerged as another option for implantation of a biological valve. Several benefits of sutureless valves have been reported in the literature. However, concerns have been raised over increased incidence of para-valvular leak and need for permanent pacemaker implantation. Most of the evidence has been obtained from observational and retrospective single institutional series. The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) trial is the first multicentric randomized control trial to compare sutureless valves with standard bio-prosthesis. Evidence from this trial has been critically analyzed in this review.

Heart Team for Optimal Management of Patients with Severe Aortic Stenosis-Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center.

Background: This retrospective study was proposed to investigate outcomes of patients with severe aortic stenosis (AS) after implementation of various treatment strategies following dedicated Heart Team (HT) decisions. Methods: Primary and secondary endpoints and quality of life during a median follow-up of 866 days of patients with severe AS qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and transcather aortic valve replacement (TAVR) or OMT and surgical aortic valve replacement (SAVR) were evaluated. As the primary endpoint composite of all-cause mortality, non-fatal disabling strokes and non-fatal rehospitalizations for AS were considered, while other clinical outcomes were determined as secondary endpoints. Results: From 2016 to 2019, 176 HT meetings were held, and a total of 482 participants with severe AS and completely implemented HT decisions (OMT, TAVR and SAVR for 79, 318 and 85, respectively) were included in the final analysis. SAVR and TAVR were found to be superior to OMT for primary and all secondary endpoints (p < 0.05). Comparing interventional strategies only, TAVR was associated with reduced risk of acute kidney injury, new onset of atrial fibrillation and major bleeding, while the superiority of SAVR for major vascular complications and need for permanent pacemaker implantation was observed (p < 0.05). The quality of life assessed at the end of follow-up was significantly better for patients who underwent TAVR or SAVR than in OMT-group (p < 0.05). Conclusions: We demonstrated that after careful implementation of HT decisions interventional strategies compared to OMT only provide superior outcomes and quality of life for patients with AS.

Transcatheter Mitral Edge-to-Edge Repair in Patients with Primary or Secondary Mitral Regurgitation

&#x0D; Four systematic reviews (SRs) and 6 retrospective cohort studies provided evidence for the clinical effectiveness of transcatheter mitral valve repair (TMVR) versus open heart conventional surgical mitral valve repair or replacement (SMVR) in patients with primary or secondary mitral regurgitation (MR). No relevant evidence regarding the cost-effectiveness of TMVR versus SMVR in patients with primary or secondary MR was identified; therefore, no summary can be provided.&#x0D; There was evidence indicating a statistically significant difference in favour of TMVR over SMVR regarding the odds of post-procedure bleeding, need for permanent pacemaker implantation, 30-day readmission, and a shorter duration of hospitalization.&#x0D; There was evidence suggesting a statistically significant difference in favour of SMVR over TMVR regarding the odds of recurrent MR, the need for reoperation, and mortality rate (i.e., during hospitalization, at 1 year, and &gt; 3 years). Also, compared with TMVR, the likelihood of residual MR grade &gt; 2 or freedom from MR grade ≥ 2 or ≥ 3 at 4 years was statistically significantly lower or higher, respectively, with SMVR.&#x0D; Evidence regarding the comparative clinical effectiveness of TMVR versus SMVR concerning stroke, acute kidney injury (AKI), cardiogenic shock, and death during hospitalization was conflicting and inconclusive.&#x0D; There was no evidence of a significant difference between the 2 interventions regarding overall mortality or mortality at 5 years, overall survival, freedom from cardiac death at 4 years, cardiac arrest, acute myocardial infarction (MI), and respiratory or vascular complications.&#x0D; A major limitation of the evidence was that it derives from studies of low or unknown quality and risk of bias, Furthermore, all the findings are confounded by differences in patient selection, which reflect the approved indications for the interventions but prevent a direct comparison between the TMVR and SMVR groups.&#x0D;

Prognostic impact of percentage of ventricular pacing in patients requiring pacemaker implantation after transcatheter aortic valve replacement

Abstract Background Despite the continuous developments of transcatheter aortic valve implantation (TAVI), around 15% of the patients (P) who undergo this procedure require permanent pacemaker (PM). Right ventricular pacing (RVP), particularly with a cumulative percentage of ventricular pacing (CVp) above 40%, has been associated with detrimental effects on ventricular function and an increased risk of cardiovascular events in non-TAVI patients. Aim To evaluate the long-term prognostic significance of RVP, regarding overall mortality and the combined endpoint of overall mortality/heart failure hospitalization in P requiring a PM after TAVI. Methods We retrospectively examined P who underwent TAVI with a self-expanding valve from 2009 to 2020 at our institution. All P had pre-procedural clinical evaluation, cardiac computed tomographic angiography, transthoracic echocardiography and electrocardiography performed. CVp was determined from stored PM data. P with previous PM were excluded. Post-TAVI PM implantation was defined as a device implantation during hospital stay or during the first month after discharge. Results 474P, 57% male, mean age 81.7±6.5 years with a mean left ventricular ejection fraction of 51.5±14.6% were analysed. Mean follow-up was 18.7 months. Mean STS score and mean Euroscore II were, respectively, 6.89% and 5.76%. Mean gradient was 51.67 mmHg and mean aortic valve area 0.71 cm2. After TAVI, 104P (21.9%) required PM implantation, with a mean CVp of 65.3±43.4%. Post-TAVI PM was not associated with a worse outcome - overall mortality: HR 1.13, 95% CI 0.72 – 1.78, p=0.57; combined mortality/heart failure hospitalization: HR 1.22, 95% CI 0.87 – 1.70, p=0.24. The follow-up Kaplan-Meier curves according to the need for PM post-TAVI were similar: log rank p=0.24. A CVp cut-off of 40% was not associated with any of the study endpoints - overall mortality: HR 1.72, 95% CI 0.38–7.86, p=0.48; combined mortality/heart failure hospitalization: HR 1.32, 95% CI 0.45–3.91, p=0.61. Also, a CVp cut-off of 40% did not provide an accurate risk stratification as survival free of events was similar between these P and those below this cut-off (log rank p=0.11) and in comparison, with P without PM (log rank p=0.65). Conclusions In P submitted to TAVI with a self-expanding valve, the need for PM implantation is common, but not associated with increased risk of total mortality or heart failure hospitalization during a 18 months follow-up period. A CVp cut-off of 40% showed poor discriminative ability regarding long-term events in this population. Funding Acknowledgement Type of funding sources: None.

Predictive factors of Permanent Pacemaker Implantation following Transcatheter Aortic Valve Replacement: membranous septum length and implantation depth evaluated with preoperative computed tomography

Abstract Background/Introduction In the last decades, transcatheter aortic valve replacement (TAVR) revolutionized the treatment of symptomatic severe aortic stenosis. Cardiac conduction disturbances (CD) and the need for permanent pacemaker implantation (PPMI) remain the most frequent drawback of TAVR.The efficacy and safety of TAVR is proven not only in inoperable and high-risk patients, but TAVR use is increasing rapidly among intermediate- and low-risk populations, including progressively younger patients. In these prospective the risk of new-onset CD becomes increasingly important in clinical management. Several pre-procedural nonmodifiable factors (e.g., right bundle branch block [RBBB]) and modifiable factors (such as valve type and implantation depth) have been associated with conduction disturbances post-TAVR. Purpose The His bundle passes through the membranous septum (MS) and it is therefore not surprising that deeper valve implantation increases the likelihood of mechanical damage of the His bundle, leading to a transient or persistent CD. To date, it remains uncertain whether the association between valve type and CD relates primarily to a valve class effect or it is mainly secondary to differences in valve positioning accuracy and implantation depth between valve types. The aim of this study is to evaluate the length of the membranous septum (MS) and the implant depth (ID) in relation to the risk of permanent pacemaker (PPM) with both balloon-expandable (BE) and self-expanding (SE) transcatheter heart valves. Methods Of the 104 patients in the study, 79 patients underwent TAVIs with BE (44) and SE valves (35). Using preoperative computed tomography (CT) and angiography, MS length and implantation depth (ID) were retrospectively assessed. 14 patients were excluded for the presence of pre-TAVI PPM, 3 for the presence of congenital bicuspid aortic valve, 8 due to the presence of non-evaluable CT angiography. Results In the study population, out of the total of 79 patients, PPMs were implanted in 8 patients (10.12%), of which 7 in 35 (20%) patients undergoing TAVI with SE and 1 in 44 (2.27%) with BE valves. The measurements of MS was 4±2.1 mm for BE vs 3.3±2 mm for SE valves (p=0.141) and ID was 4.9±1.7 mm for BE vs 5.9±3.2 mm for SE valves (p=0.046). At multivariate logistic regression, two significant variables related to the post-TAVI PPMI were identified: MS (p=0.029) and ID (p=0.009), moreover the MS / ID ratio represents an additional predictor for PPMI regardless of the type of valve used (p=0.002). Conclusion(s) The study confirms the importance of the pre-TAVI MS length measurement for both types of valves. The only modifiable factor is the implantation technique which, knowing the PPMI's preoperative risk must be modified according to the patient's septum. Therefore it will be possible to modify the valve ID according to the patient's septum, looking for higher implants in higher-risk cases, particularly with self-expanding valves. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): No fundings

Transcatheter aortic valve replacement in severe aortic stenosis and cardiac amyloidosis: a systematic review and meta-analysis

Abstract Background Aortic stenosis (AS) and cardiac amyloidosis (CA) are typical degenerative diseases of the elderly. According to recent studies, up to 16% of patients referred to transcatheter aortic valve replacement (TAVR) have a concomitant diagnosis of CA. Until recently, TAVR in patients with CA and AS has been considered futile, following the results of small observational studies. However, few studies recently suggested a beneficial impact of TAVR in patients with AS and CA as compared with medical therapy alone. Purpose To clarify the efficacy and safety profile of TAVR in CA-AS patients. Methods We performed a systematic review and meta-analysis of studies evaluating the risk of mortality after TAVR in CA-AS patients as compared with medical therapy. Moreover, we performed a systematic review and descriptive meta-analysis of studies reporting outcomes and complication rates of TAVR in CA-AS patients as compared with patients with AS alone. Results We identified 4 observational studies reporting data on mortality in CA-AS patients treated with either TAVR or medical therapy. Mortality was significantly lower in patients undergoing TAVR (OR 0.23, 95% CI 0.07–0.73, I2=0%, NNT=2.6) as compared with medical therapy. A sensitivity analysis with hazard ratio as effect estimate showed consistent results. Then, we identified 4 observational studies reporting data on mortality, re-hospitalizations and periprocedural complications of TAVR in CA-AS patients as compared with patients with AS alone. We found higher rates of mortality, cardiovascular hospitalization and need for permanent pacemaker implantation in CA-AS patients as compared to lone AS patients undergoing TAVR. Conversely, no differences were found in terms of stroke, acute kidney injury and vascular complications. Conclusions Our analysis rejects the idea of futility of TAVR in CA-AS patients showing a clear survival benefit of CA-AS patients undergoing TAVR as compared with medical therapy. Moreover, these patients may undergo TAVR with an acceptable procedural risk, that is substantially comparable to lone AS patients, except for a higher incidence of permanent pacemaker implantation. Funding Acknowledgement Type of funding sources: None.

Does age influence follow-up after alcohol septal ablation in hypertrophic obstructive cardiomyopathy?

Abstract Introduction Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease. Since its introduction in 1995 alcohol septal ablation (PTSMA) was discussed as treatment option only in elderly patients with symptomatic obstructive HCM (HOCM). We report on long-term follow-up after PTSMA with respect to patient's age. Methods and results Between 5/2000 and 6/2017 we treated 952 consecutive symptomatic HOCM patients (pts) with first PTSMA in our center. 132 (13.9%) pts were &amp;lt;40 years of age (Group A; mean age 30.3±7.7), 421 (44.2%) pts between ≥40 to &amp;lt;60 years of age (Group B; mean age 50.5±5.9) and 399 (41.9%) pts ≥60 years of age (Group C; 69.6±6.3). Family history (FH) of HCM was more often seen in Group A (50% vs. 25.7% (B) and 13.3% (C); p&amp;lt;0.ehab724.17611) as FH of sudden cardiac death (SCD) (17.4% vs. 11.2% (B) and 7.0% (C); p&amp;lt;0.01). Pts in Group C were more often in NYHA class III/IV (80.7%; p&amp;lt;0.001 each) compared to Group A (68.2%) and B (67.9%). At the time of PTSMA an ICD for primary SCD prevention had been more often implanted in Group A (19.8%; p&amp;lt;0.0001) compared to Group B (10.1%) and C (5.9%). Echocardiographic measurements showed higher maximal septal thickness in Group A (23.9±5.7 mm; p&amp;lt;0.ehab724.17611 each) compared to Group B (20.9±4.0 mm) and C (20.1±3.5 mm). Pts of Group B had lower resting gradients (60.0±35.3 mmHg; p&amp;lt;0.01 each) compared to Group A (69.5±34.8 mmHg) and C (66.4±41.6 mmHg). Total heart block at PTSMA was less often seen in Group A (28.8%; p&amp;lt;0.05 each) compared to Group B (39.4%) and C (43.4%). Due to persistent total heart block need of permanent pacemaker implantation was lowest in Group A (3.8%, p&amp;lt;0.01 each) compared to Group B (9.3%) and C (14.0%) during hospital stay. One patient in Group A and C died during hospital stay, each. Follow-up was longer in Group A (6.7±5.2 years) compared to Group C (5.5±4.8 years; p&amp;lt;0.05) and was comparable to Group B (6.2±5.1 years). Re-PTSMA was more often performed in Group A (22.7%; p&amp;lt;0.01 each) compared to Group B (12.8%) and Group C (10.5%). Reported clinical improvement at latest follow-up was comparable (93.3% Group A, 93.8% Group B, and 95.5% Group C). Mortality was highest in Group C (12.5%; p&amp;lt;0.0001 each) compared to Group A (1.5%) and B (4.0%). In Group A no pt died from cardiac reason, whereas 5 pts died from cardiac reasons in Group B and C, each. SCD was not observed in Group A, whereas 2 pts in Group B and 1 pt in Group C suffered SCD. Conclusion PTSMA is feasible even in young pts with symptomatic HOCM. Mortality after PTSMA is mainly due to non-cardiac reasons and more often seen in elderly pts. Especially, SCD could be observed in younger pts &amp;lt;40 years of age. Funding Acknowledgement Type of funding sources: None.

Two-year incidence of PPMI post SAVR, modified SAVR and TAVR

Abstract Background Moderate and high risk patients presenting with aortic stenosis are offered surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) as therapeutic options. However, both techniques are associated with postoperative conduction abnormalities necessitating permanent pace maker implantation (PPMI). Many factors have been implicated in increasing the risk of atrioventricular (AV) block and subsequent PPMI. The stress on the conduction system seems to be a major cause of this complication. Methods We conducted a study to compare the incidence of PPMI between two groups of patients. In group A, 62 patients underwent the classic SAVR and in group B, 92 patients underwent a simple modified SAVR technique (3–4 pledgeted ethibond sutures were placed above the annulus, at the commissure between the right and non coronary sinuses) that aims to decrease the mechanical trauma to the conduction system. Results The results revealed a significant lower PPMI rate in group B as compared to group A,at thirty days (2.17% versus 14.5%) as well as at two years (2.17% versus 17.7%) postoperatively. The statistical analysis showed that the operative technique was a strong predictor of the need for PPMI. The odds of needing pace maker implantation was significantly lower in the group of patients who underwent the simple modified SAVR technique. Of note is that the reported incidence of PPMI in the literature, at thirty days and two- years post classic SAVR were 6.1% and 11%. In addition, the rate observed in group B, was lower than the post-TAVR incidence of PPMI (9.3% at thirty days and 13% at two years post procedure), as reported by numerous studies, whether self expandable or balloon expandable valves were used. Conclusion This reproducible and reliable simple technique should be recommended whenever SAVR is performed.On the other hand,the low incidence of PPMI (2.17%) observed after a modified SAVR technique should be adopted as a benchmark whenever TAVR is offered as a therapeutic option. Moreover, this less traumatic procedure may be taken into consideration whenever stent design modifications for TAVR are considered. Funding Acknowledgement Type of funding sources: None.

The South African SHARE-TAVI registry: incidence and risk factors leading to conduction disturbances requiring permanent pacemaker implantation

Background: One of the most common complications post transcatheter aortic valve implantation (TAVI) is the development of heart block requiring permanent pacemaker implantation (PPM). The incidence of PPM in international registries ranges from 13% - 17.5%. Methods: The aim of this observational study was to report the PPM rate in the SHARE-TAVI registry and determine the clinical, electrocardiographic and procedural predictors of PPM as well as the effect of PPM on clinical outcomes. Results: Three hundred and fi ve subjects were analysed. The PPM rate was 9%. Third degree atrioventricular block at the time of implant was the most common indication for PPM. Self-expanding valves (PPM rate 14% vs. 6% for balloon-expandable valves, p=0.02) were correlated with the need for PPM. Baseline ECG predictors of PPM were axis deviation, QRS duration and conduction delay, most notably a pre-existing right bundle branch block (OR 15.88, p&lt;0.01). PPM infl uenced functional class at 30 days, but not the need for repeat hospitalisation or mortality at 30-day and 1-year follow-up. Conclusions: A PPM rate lower than that reported in large international registries was found. Predictors of PPM and the infl uence of PPM on outcomes were similar to those reported in the international data.

Conduction delays after transcatheter aortic valve implantation with balloon-expandable prosthesis and high implantation technique

Performing transcatheter aortic valve implantation with high implantation technique, i.e. with an aorto-ventricular ratio > 60/40, reduces the need of permanent pacemaker implantation. Valve calcification and prosthesis oversizing are predictors of permanent pacemaker implantation, but there are no available data on their role when transcatheter aortic valve implantation is performed with an aorto-ventricular ratio > 60/40. The aim of this study was to evaluate the effect of leaflets/annulus calcification and prosthesis oversizing on the incidence of permanent pacemaker implantation after transcatheter aortic valve implantation with a high implantation technique. Transcatheter aortic valve implantation was performed in 48 patients implanting a balloon-expandable transcatheter heart valve with an aorto-ventricular ratio > 60/40. Calcium burden was assessed by preprocedural multidetector computed tomography. An invasive electrophysiological study was performed before and after transcatheter aortic valve implantation. Five patients (10.4%) needed permanent pacemaker implantation. At univariate analysis, baseline right bundle branch block and postprocedural PR, QRS and His-ventricular interval elongation significantly predicted permanent pacemaker implantation (p < 0.05). Receiver-operating characteristic curve analysis showed a correlation between transcatheter heart valve oversizing and permanent pacemaker implantation need, with the best cut-off being 17% (AUC = 0.72, p = 0.033). Linear regression analysis demonstrated that QRS complex elongation was related to total, left and non-coronary leaflet calcification (p < 0.05). This study demonstrates that, when transcatheter aortic valve implantation is performed using a balloon-expandable transcatheter heart valve deployed with an aorto-ventricular ratio > 60/40, the presence of leaflets/annulus calcification or the need to oversize the prosthesis correlate with the occurrence of pathological cardiac conduction delays.

Transcatheter aortic valve replacement: impact of pre-procedural FEops HEARTguide assessment on device size selection in borderline annulus size cases.

ObjectivesThe aim of this study is to evaluate device size selection in patients within the borderline annulus size range undergoing transcatheter aortic valve replacement (TAVR) and to assess if pre-procedural patient-specific computer simulation will lead to the selection of a different device size than standard of care.BackgroundIn TAVR, appropriate device sizing is imperative. In borderline annulus size cases no standardised technique for tailored device size selection is currently available. Pre-procedural patient-specific computer simulation can be used, predicting the risk for paravalvular leakage (PVL) and need for permanent pacemaker implantation (PPI).MethodsIn this multicentre retrospective study, 140 patients in the borderline annulus size range were included. Hereafter, device size selection was left to the discretion of the operator. After TAVR, in 24 of the 140 patients, patient-specific computer simulation calculated the most appropriate device size expected to give the lowest risk for PVL and need for PPI. In these 24 patients, device size selection based on patient-specific computer simulation was compared with standard-of-care device size selection relying on a standardised matrix (Medtronic).ResultsIn a significant proportion of the 140 patients (26.4%) a different device size than recommended by the matrix was implanted. In 10 of the 24 patients (41.7%) in whom a computer simulation was performed, a different device size was recommended than by means of the matrix.ConclusionsDevice size selection in patients within the borderline annulus size range is still ambiguous. In these patients, patient-specific computer simulation is feasible and can contribute to a more tailored device size selection.

Predictors of pacemaker implantation after TAVI in a registry including self, balloon and mechanical expandable valves.

The need for permanent pacemaker implantation (PPMI) is a burdensome complication of transcatheter aortic valve implantation (TAVI). The aim of our study was to evaluate different anatomical, clinical, electrocardiographic, and procedural variables associated with the development of conduction abnormalities after TAVI across the entire device spectrum.Single-center prospective cohort of consecutive patients who underwent TAVI since March 2017. Final cohort was studied to detect areas of calcium within aortic valve characterized by leaflet sector and region. Membranous septum (MS) length was assessed throughout a modified coronal view. Device selection and positioning were performed according to the operator criteria.Device selection and positioning were performed according to the operator criteria. From the 273 patients included, 57 underwent PPMI (20.8%). Univariate analysis determined right bundle branch block (RBBB), QRS duration, MS length and calcium within LVOT of non-coronary cuspid as independent predictors. After multivariable logistic regression, both RBBB (OR 6.138; 95% CI 1.23-30.73, P = 0.027) and MS length (OR 0.259; 95% CI 0.164-0.399, P < 0.005) emerged as statistically significant. As a model, they could predict PPMI in 88.7%, independently of which valve used. Youden index analysis yielded 7.69 mm as the optimal cut-off with a negative and positive predictive value of 94.7 and 71.9%, respectively.In our experience, both RBBB pattern and short membranous septum (< 8 mm) were strongly and independently associated with new permanent pacemaker implantation, regardless of the device type. Our findings suggest that this simple evolved measure of MS length may guide device selection and implantation technique and facilitate early discharge.

Evaluation and Management of Heart Block After Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) has developed substantially since its inception. Improvements in valve design, valve deployment technologies, preprocedural imaging and increased operator experience have led to a gradual decline in length of hospitalisation after TAVR. Despite these advances, the need for permanent pacemaker implantation for post-TAVR high-degree atrioventricular block (HAVB) has persisted and has well-established risk factors which can be used to identify patients who are at high risk and advise them accordingly. While most HAVB occurs within 48 hours of the procedure, there is a growing number of patients developing HAVB after initial hospitalisation for TAVR due to the trend for early discharge from hospital. Several observation and management strategies have been proposed. This article reviews major known risk factors for HAVB after TAVR, discusses trends in the timing of HAVB after TAVR and reviews some management strategies for observing transient HAVB after TAVR.

Impact of Left Ventricular Outflow Tract Calcification on Outcomes Following Transcatheter Aortic Valve Replacement

BackgroundWe aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses. Materials/methodsWe conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable. ResultsWe included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% (p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99–1.02). ConclusionsTAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR.

Transcatheter aortic valve replacement using the new Evolut-Pro system: a prospective comparison with the Evolut-R device.

BackgroundEvolut Pro (EVP) is a novel self-expandable aortic valve. This prosthesis consists of an external porcine pericardial wrap designed to reduce paravalvular leak (PVL), maintaining the benefits of its predecessor, the Evolut R (EVR). The aim was to compare the functional and clinical results in the short and medium term of the new EVP with the EVR system.MethodsConsecutive patients receiving either the EVR (n=50) or the EVP (n=33) from June 2015 to October 2018 were compared. Baseline characteristics, cardiovascular imaging, procedural outcomes, short and mid-term follow-up outcomes were prospectively collected and assessed.ResultsResidual mild PVL was common and comparable in the two groups (EVR 79% vs. EVP 70%; P=0.4). In the EVR group, the presence of PVL was directly related to prosthesis size, but this correlation was not observed in the EVP group. Conduction abnormalities were more prevalent with the EVP, but these did not translate into a higher need of permanent pacemaker implantation. Vascular and bleeding complications were infrequent in both groups. At mid-term clinical follow-up (median survival time: EVR 11±0.3 months, EVP 12±0.2 months), the 1-year rate of adverse events was similar (EVR: 24%, EVP: 33%; P=0.3).ConclusionsBoth protheses are effective for the treatment of severe aortic stenosis with excellent results at mid-term clinical follow up. The EVP remains associated with a significant rate of residual mild PVL that appears to be similar to that observed with EVR.