171 Definitive pacemaker requirement after percutaneous Edwards Sapien aortic valve implantation: a rare complication

In 2009, more than 6000 patients have been treated with percutaneous aortic valve implantation using one of the two commercialized models of bioprothesis. The occurrence of complete atrioventricular block (AV-Block) requiring a pacemaker was described after implantation, particularly with the Corevalve (up to 25%).Purpose of the StudyTo evaluate the occurrence of conduction abnormalities and requirements for permanent pacing after Edwards Sapien aortic valve implantation.MethodsWe analyzed the standard 12-lead electrocardiograms (ECGs) of 55 consecutive Pts in whom an Edwards Sapien aortic valve was successfully implanted between June 2006 and December 2008 using either trans-femoral or trans-apical approach. We examined the ECGs before treatment, at day 1, and at one-month and analyzed the presence of a second or third-degree AV-block.ResultsMean age was 82 +/- 8.4 years and 46% were female. Logistic Euroscore was 27.8 + 14.9%. We noted a slight increase in HR at day-1 (78.8 + 16 vs 74.9 + 13 b / min, p=0.005) with decrease in QT interval (395±47.7 vs 416.8±40.2 ms, p=0.02). These values returned to baseline values at 1 month. There was no change in PR interval (198.8±42.4 vs 199.7±45.7 ms at day 1, p=0.98 and 199.3±39.8 ms at day 30, p=0.56) and QRS duration (113.3±26.2 vs 116.8±28 ms at day 1, p=0.14 and 113.2±25.4 ms at day 30, p=0.63) neither in the occurrence of hemiblocks. A new left bundle branch developed in 5 Pts (9%) at day one but was not present anymore at day-30. A permanent pacemaker was implanted in 2 cases (4.1%) for 3-degree AV-block: at day 3 one for persistent AV-Block developed immediately after aortic valve predilatation and at day 10 in the second case due to the delayed occurrence of 3-degree AV-Block.ConclusionsIn our experience, conductive disorders and the requirement of a definitive pacemaker after implantation of an Edwards-Sapien bioprothesis are unfrequent (4.1%)

Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction, Resuscitated Cardiac Arrest, and Cardiogenic Shock The Role of Primary Multivessel Revascularization

ObjectivesThis study sought to assess the impact of multivessel (MV) primary percutaneous coronary intervention (PCI) on clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) presenting with cardiogenic shock (CS) and resuscitated cardiac arrest (CA).BackgroundThe safety and efficacy of MV primary PCI in patients with STEMI and refractory CS is unknown.MethodsWe conducted a multicenter prospective observational study of consecutive STEMI patients presenting to 5 French centers. Patients were classified as having single-vessel (SVD) or multivessel (MVD) coronary disease, and underwent culprit-only or MV primary PCI. Baseline characteristics and 6-month survival were compared.ResultsAmong 11,530 STEMI patients, 266 had resuscitated CA and CS. Patients with SVD (36.5%) had increased 6-month survival compared to those with MVD (29.6% vs. 42.3%, p = 0.032). Baseline characteristics were similar in those with MVD undergoing culprit-only (60.9%) or MV (39.1%) primary PCI. However, 6-month survival was significantly greater in patients who underwent MV PCI (43.9% vs. 20.4%, p = 0.0017). This survival advantage was mediated by a reduction in the composite of recurrent CA and death due to shock (p = 0.024) in MV PCI patients. In those with MVD, culprit artery PCI success (hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.41 to 0.96, p = 0.030) and MV primary PCI (HR: 0.57; 95% CI: 0.38 to 0.84, p = 0.005) were associated with increased 6-month survival.ConclusionsThe results of this study suggest that in STEMI patients with MVD presenting with CS and CA, MV primary PCI may improve clinical outcome. Randomized trials are required to verify these results

M004 In aortic stenosis, 2D speckle tracking differentiates left ventricular dysfunction load- to remodelling-dependant

BackgroundIn aortic stenosis, it is not known which between longitudinal, radial and circumferential contraction is influenced by loading conditions or remodelling. To test our hypothesis and to understand left ventricular function recovery, we investigated patients at early, i.e. 7 days (contractility enhancement load-dependant) and at late follow-up, i.e. 3 months (contractility enhancement remodelling-dependant) after transcutaneous aortic valve implantation (TAVI).Methods and ResultsTwenty-three subjects (AS: valve orifice < or =0.7cm2; 14 female; mean age, 84+/-6 years) were studied. All subjects of the study had conventional 2D-Doppler echocardiography and speckle tracking analysis (GE HealthCare). Speckle tracking was sampled in short-axis view for radial and circumferential strain and in apical 4, 3 and 2-chamber view for averaged longitudinal strain. Measurements were performed before, 7 days and 3 months after TAVI. Mean pressure gradient decreased from 41±20mmHg to 10±3mmHg (p<0.001) while aortic valve area increased from 0.6±0.1 to 1.7±0.2cm2 (p<0.001) after implantation. Biplane Simpson EF was 50±10 %, 51±13 and 58±11 % at baseline, 7-day and 3-month follow-up (p=0.01), respectively. Improvement of circumferential strain found 7 days after TAVI is sustained at 3 months. Radial strain increased shortly after TAVI, then decreased at 3 months and was compensated by improvement of longitudinal strain (see figure).ConclusionIn patients with aortic stenosis, radial contraction is load dependant, circumferential contraction is both load- and remodelling-dependant, whereas longitudinal contraction is remodeling-dependant

Multicenter Evaluation of Edwards SAPIEN Positioning During Transcatheter Aortic Valve Implantation With Correlates for Device Movement During Final Deployment

ObjectivesThis study sought to evaluate the exact location of Edwards SAPIEN (Edwards Lifesciences, Irvine, California) devices in different stages of implantation and to quantify possible operator-independent device movement during final deployment.BackgroundAccurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results.MethodsThis multicenter study consisted of 68 procedures with reliable pacemaker capture. Device positions were assessed using fluoroscopic images and the C-THV system (Paieon Medical, Rosh Ha'Ayin, Israel).ResultsThe location after implantation was significantly higher than in the final stage of rapid pacing: 16.7 ± 16.3% of device height below the plane of the lower sinus border versus 32.6 ± 13.8%, p < 0.0001. Operator-independent device-center upper movement during final deployment was 2 ± 1.43 mm, range: −1.3 to 4.6 mm. Device movement was asymmetrical, occurring more in the lower part of the device than in its upper part (3.2 ± 1.4 mm vs. 0.75 ± 1.5 mm, p < 0.001), resulting in device shortening. Multivariate analysis revealed that moderate and severe aortic valve calcification had 49% higher upward movement than mild calcification (p = 0.03), and aortic sinus volume was negatively correlated with movement size (r = −0.35, p = 0.005). This movement was independent of device version (SAPIEN vs. SAPIEN XT), procedural access (transfemoral vs. transapical), and interventricular septum width.ConclusionsThe final Edwards SAPIEN position is mostly aortic in relation to the lower sinus border. There is an operator-independent upward movement of the device center during the final stage of implantation. Anticipated upward movement of the device should influence its positioning before final deployment

Prognostic significance of vascular and valvular calcifications in low- and high-gradient aortic stenosis

International audienceAims In low-gradient aortic stenosis (LGAS), the high valvulo-arterial impedance observed despite low valvular gradient suggests a high vascular load. Thoracic aortic calcifications (TACs) and valvular aortic calcifications (VACs) are, respectively, surrogates of aortic load and aortic valvular gradient. The aim of this study was to compare the respective contributions of TAC and VAC on 3-year cardiovascular (CV) mortality following TAVI in LGAS vs. high-gradient aortic stenosis (HGAS) patients. Methods and results A total of 1396 consecutive patients were included. TAC and VAC were measured on the pre-TAVI CT-scan. About 435 (31.2%) patients had LGAS and 961 (68.8%) HGAS. LGAS patients were more prone to have diabetes, coronary artery disease (CAD), atrial fibrillation (AF), and lower left ventricular ejection fraction (LVEF), P&lt;0.05 for all. During the 3 years after TAVI, 245(17.8%) patients experienced CV mortality, 92(21.6%) in LGAS and 153(16.2%) in HGAS patients, P=0.018. Multivariate analysis adjusted for age, gender, diabetes, AF, CAD, LVEF, renal function, vascular access, and aortic regurgitation showed that TAC but not VAC was associated with CV mortality in LGAS, hazard ratio (HR) 1.085 confidence interval (CI) (1.019–1.156), P=0.011, and HR 0.713 CI (0.439–1.8), P=0.235; the opposite was observed in HGAS patients with VAC but not TAC being associated with CV mortality, HR 1.342 CI (1.034–1.742), P=0.027, and HR 1.015 CI (0.955–1.079), P=0.626. Conclusion TAC plays a major prognostic role in LGAS while VAC remains the key in HGAS patients. This confirms that LGAS is a complex vascular and valvular disease

Impact of Preexisting Left Bundle Branch Block in Transcatheter Aortic Valve Replacement Recipients

BACKGROUND The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR. METHODS AND RESULTS This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12-2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84-2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75-1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68-1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up ( P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB ( P=0.327). CONCLUSIONS Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB

One year follow-up of the multi-centre European PARTNER transcatheter heart valve study

BackgroundTranscatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis.AimsPARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach.Methods and resultsPrimary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7, P <0.0005) and more peripheral disease (49.3 vs. 16.4, P< 0.0001). Procedures were aborted in four TA (5.8) and six TF cases (9.8). Valve implantation was successful in the remaining patients in 95.4 and 96.4, respectively. Thirty days and 6 months survival were 81.2 and 58.0 (TA) and 91.8 and 90.2 (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8 of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7 had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively.ConclusionThis first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes

Inadequacy of Existing Clinical Prediction Models for Predicting Mortality after Transcatheter Aortic Valve Implantation

Background: The performance of emerging transcatheter aortic valve implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry. Methods: The calibration and discrimination of each CPM were analyzed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route, and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analyzed at an individual patient level. Results: The observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss's kappa values between 0.17 and 0.50. Conclusions: Although the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries

Sex-Specific Considerations in Degenerative Aortic Stenosis for Female-Tailored Transfemoral Aortic Valve Implantation Management

The impact of sex on pathophysiological processes, clinical presentation, treatment options, as well as outcomes of degenerative aortic stenosis remain poorly understood. Female patients are well represented in transfemoral aortic valve implantation (TAVI) trials and appear to derive favorable outcomes with TAVI. However, higher incidences of major bleeding, vascular complications, and stroke have been reported in women following TAVI. The anatomical characteristics and pathophysiological features of aortic stenosis in women might guide a tailored planning of the percutaneous approach. We highlight whether a sex-based TAVI management strategy might impact on clinical outcomes. This review aimed to evaluate the impact of sex from diagnosis to treatment of degenerative aortic stenosis, discussing the latest evidence on epidemiology, pathophysiology, clinical presentation, therapeutic options, and outcomes. Furthermore, we focused on technical sex-oriented considerations in TAVI including the preprocedural screening, device selection, implantation strategy, and postprocedural management