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To compare in-hospital outcome of Evolut-R 34 mm vs. smaller Evolut-R devices and to identify predictors of paravalvular leak (PVL) and deep implantation specific for Evolut-R 34 mm.This single-center retrospective study included 359 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with Evolut-R 34 mm (N = 84,23.4%) and Evolut-R 23/26/29 mm (N = 275,76.6%) between 2016 and 2019.Patients in Evolut-R 34 mm group were more frequently males, had lower STS score, ejection fraction, and mean aortic gradient compared to the Evolut-R 23/26/29 mm group. Horizontal aorta and large LVOT were more frequent findings in the Evolut-R 34 mm group, whereas calcium volume was comparable among the groups. During TAVR, mean implantation depth and contrast volume were greater in the Evolut-R 34 mm group, compared to the Evolut 23/26/29 mm group. Post-procedurally, 30-day mortality, ≥moderate PVL, device success and pacemaker implantation (PM) rates were comparable between groups. Among independent predictors of ≥moderate PVL, calcium volume (OR:1.04; p0.001) was predictive with different thresholds in both groups, whereas aortic angulation (OR:1.40; p = 0.005) was predictive only in Evolut-R 34 mm group at a cutoff of 60° (AUC:0.73; p = 0.043). Body weight (OR:1.03; p = 0.027), left ventricular outflow tract (LVOT) diameter (OR:1.34; p = 0.001), and mean aortic gradient (OR:0.96; p = 0.006) were independent predictors of deep implantation (mean depth ≥ 6 mm), with LVOT27 mm being predictive specifically for Evolut-R 34 mm (AUC:0.66; p = 0.024).TAVR with Evolut-R 34 mm and Evolut-R 23/26/29 mm showed comparable in-hospital outcome. Aortic angulation60° and LVOT27 mm were predictive respectively of ≥moderate PVL and deep implantation specifically in Evolut-R 34 mm patients.

The new iteration of the Portico transcatheter heart valve delivery system, the FlexNav, has been designed to enhance procedural safety and accuracy of the platform. Major technological advancements were the significant reduction of the insertion profile, allowing a transfemoral access down to 5.0 mm vessels, and the addition of a stability layer, improving deployment accuracy and thus potentially reducing implantation depth and permanent pacemaker implantation rate. Published data on patients undergoing Portico transcatheter heart valve implantation with the new FlexNav delivery system confirms excellent procedural and 30-day safety profile.Lay abstract Transcatheter aortic valve replacement, a minimally invasive alternative to surgical aortic valve replacement, has become an established treatment option for patients with severe aortic stenosis approved across the entire spectrum of risk, from patient’s ineligible for surgery to those at low risk. With the rapid spread of transcatheter aortic valve replacement to younger patients, researchers are focusing on reducing procedural adverse events rates, such as pacemaker implantation or access site-related complication, and increase procedural accuracy. The new FlexNav delivery system, employed to implant the Portico transcatheter heart valve, had recently proved its procedural safety and, with its major technological advancements encompassing a reduced insertion profile and an improved device stability during implant, may significantly reduce pacemaker implantation and access site-related complication rate.

Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500964.

Objectives To investigate paravalvular leak (PVL) and devices success rates according to aortic angle (AA) in patients undergoing transcatheter aortic valve implantation (TAVI) with three new-generation self-expanding devices. Background The impact of aortic angle (AA) on TAVI device success and PVL rates is controversial. Methods This retrospective study included 392 patients submitted to TAVI for severe aortic stenosis with Portico, Evolut-R and Acurate-NEO, and available AA measurements at computed tomography (CT) angiography. AA was calculated from the implantation projection and was defined as the angle between the plane of aortic annulus and an ideal horizontal plane. Aorta was defined horizontal if AA>57° (75th percentile). Results In the horizontal group, the rates of moderate/severe PVL was higher in the Evolut-R group (20.8%), which was also characterized by a lower implant compared to that of Acurate-NEO, whereas device success was comparable among the three devices. AA was a significant predictor of moderate/severe PVLs (AUC 0.72, p = .002) only in the Evolut-R population. On multivariate analysis, calcium volume 850HU, bicuspid aortic valve, and implantation depth at the level of left coronary cusp were independent predictors of moderate/severe PVL. On univariate analysis in the horizontal aorta population, implantation depth was confirmed among the most significant predictors of moderate/severe PVL. Conclusions Despite comparable device success rates, horizontal aorta represented a technical challenge only in the Evolut-R subgroup, which showed higher rates of moderate/severe PVL than Portico and Acurate-NEO, and was associated with a low implant.

OBJECTIVE This study sought to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation for failed surgical bioprostheses (TAVI-ViV) with Portico device. BACKGROUND Limited evidence coming from early experience on Portico system does not allow to fully assess safety and efficacy of this device in this ViV patients. METHODS From January 2016 up to June 2019, 56 consecutive patients undergoing TAVI-ViV with Portico were prospectively included in our institutional TAVI database. RESULTS The prevalent mechanism of failure was stenosis (58.9%); true internal diameter (ID) was

Background In HFrEF patients, high pulmonary vascular resistances (PVR) imply a combined increase of both pre- and post-capillary pressures, associated with worse outcome. Mitral regurgitation (MR) may play a role in this complex physiopathology. We sought to investigate MR impact on lung DLCO and pulmonary vascular hemodynamic in HFrEF patient. Methods 27 HFrEF patients (age 69 ± 9; LV EF 34 ± 6) underwent right heart catheterization, rest and exercise echocardiography, right ventricle 3D assessment and lung alveolo-capillary membrane DLCO. We identified 2 subgroups divided by normal (3 WU, n = 7) PVR. Results Abnormal PVR patients showed increased pulmonary artery pressures and TPG, reduced CO and pulmonary artery compliance. Total DLCO was not significantly different between groups. The membrane component (Dm) and the alveolar volume (Va) were significantly reduced in abnormal PVR group, while the capillary volume (VC) showed a strong trend toward higher values. Abnormal PVR group had a very high percentage of moderate-to-severe MR. The TASPE/SPAP ratio and the circumferential component of RV systolic function were significantly reduced in abnormal PVR group. Conclusion The presence of severe MR is associated with alveolar-capillary membrane remodeling (lower Dm), worse hemodynamic profile (higher PA pressures, lower PA compliance and higher PA resistance) and worse right ventricle to pulmonary circulation coupling (lower TAPSE/SPAP and lower 3D RV circumferential EF) in this cohort of HFrEF patients. These results confirm the adequacy of using therapeutic strategies aimed to solve valvular disease.

Background the TAPSE/SPAP ratio has gained a role as an easy-to-use surrogate of right ventricle-to-pulmonary circulation (RV-PC) coupling, showing a strong prognostic significance in heart failure (HF) patients. The hemodynamic determinants of TAPSE/SPAP ratio, as assessed by invasive approach, have not been fully clarified. Aim To identify the right heart hemodynamic variables correlated with TAPSE/SPAP in a HF with reduced EF (HFrEF) cohort, both at rest and during exercise. Methods 30 HFrEF patients (age 68 ± 10 years LV EF 28 ± 7) underwent to rest and exercise echocardiography and performed right heart catheterization within 24 hours. Bivariate correlations between TAPSE/SPAP ratio (at rest and during exercise), right heart hemodynamic variables, RV systolic function and NTproBNP have been explored. Results TAPSE/SPAP ratio at rest showed a moderate correlation with pulmonary artery wedge pressure (PAWP: r= 0.441; p= 0.039), pulmonary artery pressures (PAP systolic: r = 0.481; p= 0.026; PAP diastolic: r= 0.434; p= 0.043; mPAP: r= 0.476; p= 0.025), pulmonary vascular resistance and compliance (r= 0.475; p= 0.041). A stronger correlation was identified with right atrial (RAP systolic: r= 0.586; p= 0.017; RAP diastolic: r= 0.681; p= 0.006) and right ventricular pressures- in particular diastolic ones (RVP systolic: r= 0.584; p= 0.004; RAP diastolic: r= 0.652; p= 0.002). No significant correlation with NTproBNP and RV 3D EF emerged. Exercise TAPSE/SPAP ratio significantly correlated with right atrium (RAP systolic: r= 0.564; p= 0.036) and right ventricle systolic pressures only (RVP systolic: r= 0.789; p< 0.001). Conclusions TAPSE/SPAP ratio at rest showed a stronger correlation with invasively derived diastolic right heart pressure rather than pulmonary vascular bed pressures. A similar correlation was also observed for exercise TAPSE/SPAP ratio. This tight correlation with RV, rather than with vascular pressures, supports the significance of this ratio as a marker of RV adaptation to vascular overload.

Right ventricular dysfunction (RVdy) is negatively associated with survival after left heart valve surgery. It is unclear whether RVdy has the same impact in patients undergoing transcatheter aortic valve implantation (TAVI). We sought to evaluate the prognostic impact of different grades of RVdy on TAVI, with and without concomitant left ventricular dysfunction (LVdy), and the possible impact of TAVI on RVdy.Among 870 consecutive patients with severe symptomatic aortic stenosis undergoing TAVI, 226 patients (26%) presented with a concomitant diagnosis of RVdy. Patients were divided into three groups, Group 1: normal RV systolic function, i.e., tricuspid annular plane systolic excursion (TAPSE)16 mm (n=644, 74%); Group 2: mild-to-moderate RVdy, i.e., TAPSE 10-16 mm (n=180, 20.6%); Group 3: severe RVdy, i.e., TAPSE10 mm (n=46, 5.2%). Patients in Groups 1 and 2 showed a similar overall mortality rate at one month (5% vs. 8%, OR 1.1 [0.7-1.55], p=0.2) and at one-year follow-up (15% vs. 19%, HR 1.5 [0.84-2.2], p=0.09), respectively. Compared to Groups 1 and 2, patients in Group 3 showed a significantly higher overall mortality at one month (22%, OR 3.3 [1.8-4.1], p0.001, and OR 2.1 [1.7-3.1], p=0.02, respectively) as well as at one-year follow-up (45%, HR 2.6 [2.1-3.45], p0.001, and HR 1.9 [1.5-2.7], p=0.02), respectively. Pulmonary hypertension60 mmHg (HR 1.5 [1.1-2.2], p=0.03), AF (HR 1.6 [1.1-2.4], p=0.01), creatinine clearance30 mL/min (HR 1.92 [1.3-2.5], p=0.003), LVEF30% (HR 1.5 [1.1-2.9], p=0.03), severe RVdy (HR 2.9 [2.7-3.3], p=0.002), severe RV dilation (HR 1.7 [1.2-2.2], p=0.005) and severe biventricular dysfunction (HR 3.9 [2.7-4.1], p=0.002) were independent predictors of one-year mortality. Among survivors, the majority of patients in Groups 2 and 3 experienced a significant improvement in NYHA class.Severe RVdy limits the expected benefit of TAVI. In current risk scores right heart failure is not considered. The present study advocates the evaluation of this strong predictor in a more complete pre-procedural work-up.

Background In HFrEF patients, high pulmonary vascular resistances (PVR) reflect a combined increase of pre- and post-capillary pressures, associated with worse outcome. Mitral regurgitation (MR) may play a role in this complex physiopathology. We sought to investigate MR impact on lung DLCO and pulmonary vascular hemodynamic in HFrEF patient. Methods 22 HFrEF patients (age 67±11; LV EF) underwent right heart catheterization, rest and exercise echocardiography, right ventricle 3D assessment and lung alveolo-capillary membrane DLCO. We identified 2 subgroups according to normal (3 WU, n=5) PVR. Results Abnormal PVR patients showed increased pulmonary artery pressures and TPG, reduced CO and pulmonary artery compliance. Total DLCO was not significantly different between groups. The membrane component (Dm) and the alveolar volume (Va) were significantly reduced in abnormal PVR group, while the capillary volume (VC) showed a strong trend toward higher values. Abnormal PVR group had a very high percentage of moderate-to-severe MR. The TASPE/SPAP ratio and the circumferential component of RV systolic function were significantly reduced in abnormal PVR group. Normal PVR (n=17) Abnormal PVR (n=5) p NTproBNP, ng/L 3021±2527 7023±8785 0.55 MR moderate-to-severe, n (%) 3 (19%) 4 (80%) 0.025 TAPSE/SPAP, mm/mmHg 0.4761±0.1695 0.2956±0.0739 0.019 3D RV global EF, % 40.616±9.350 29.486±14.062 0.119 3D RV longitudinal EF, % 15.611±7.773 12.086±9.694 0.497 3D RV circumferential EF, % 31.0567±6.5744 21.1746±11.5823 0.019 Lung diffusion of CO (DLCO), ml/min/mmHg 19.021±4.643 15.233±1.761 0.197 Dm ml/min/mmHg 26.8±8.2 17.8±4.1 0.047 VC, ml 110±77 247±152 0.121 Graphics Conclusion The presence of severe MR, in this cohort of HFrEF patients, is associated with alveolar-capillary membrane remodeling (lower Dm), worse hemodynamic profile (higher PA pressures, lower PA compliance and higher PA resistance) and worse right ventricle to pulmonary circulation coupling (lower TAPSE/SPAP and lower 3D RV circumferential EF), confirming the use of therapeutic strategies aimed at correction of valvular disease.

Background The TAPSE/SPAP ratio has gained a role as an easy-to-use surrogate of right ventricle-to-pulmonary circulation (RV-PC) coupling, showing a strong prognostic significance in heart failure (HF) patients. The hemodynamic determinants of TAPSE/SPAP ratio, as assessed by invasive approach, have not been fully elucidated. Aim To identify the right heart hemodynamic variables correlated with TAPSE/SPAP in a HF with reduced EF (HFrEF) cohort, at rest and during exercise. Methods 24 HFrEF patients (age 67±11 years LV EF 27±7) underwent to rest and exercise echocardiography and performed right heart catheterization within 24 hours. Bivariate correlations between TAPSE/SPAP ratio (at rest and exercise), right heart hemodynamic variables, RV systolic function and NTproBNP have been explored. Results TAPSE/SPAP ratio at rest showed a moderate correlation with pulmonary artery wedge pressure (PAWP: r=0.432; p=0.039), pulmonary artery pressures (PAP systolic: r=0.474; p=0.026; PAP diastolic: r=0.434; p=0.043; mPAP: r=0.476; p=0.025), pulmonary vascular resistance and compliance (r=0.475; p=0.041), while a stronger correlation was identified with right atrial (RAP systolic: r=0.571; p=0.017; RAP diastolic: r=0.675; p=0.006) and right ventricular pressures- in particular diastolic ones (RVP systolic: r=0.584; p=0.004; RAP diastolic: r=0.646; p=0.002). No significant correlation was found with NTproBNP and RV 3D EF. Exercise TAPSE/SPAP ratio significantly correlated with right atrium (RAP systolic: r=0.564; p=0.036) and right ventricle systolic pressures only (RVP systolic: r=0.765; p TAPSE/PAPS correlation graphics Conclusions TAPSE/SPAP ratio at rest showed a stronger correlation with invasively derived diastolic right heart pressure rather than pulmonary vascular bed pressures. A similar correlation was also observed for exercise TAPSE/SPAP ratio. This tight correlation with RV, rather than vascular pressures, supports the significance of the ratio as a marker of RV adaptation to vascular overload.

The introduction into clinical practice of transcatheter aortic valve implantation (TAVI) has led to a significant change in the therapeutic paradigm for patients with valvular aortic stenosis. However, in parallel with the benefits obtained in prognosis and quality of life, an inherent risk of major cerebral thromboembolic events has been observed. In different studies this risk has been estimated between 2% and 6%. In order to reduce the incidence of cerebrovascular accidents during TAVI, several brain protection systems have been developed but, to date, none has obtained sufficient clinical evidence to be implemented on a large scale, and they are therefore used only in selected cases. Furthermore, periprocedural drug therapy and follow-up are still the subject of extensive discussion in the scientific community. This paper reviews the topic of stroke prevention in patients undergoing TAVI for both the periprocedural and postprocedural aspects.

Background Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for severe aortic stenosis (AS). AS and coronary artery disease frequently coincide, and therefore some patients may require coronary angiography (CAG) and/or intervention (PCI) post-TAVR. Due to valve stent design, most self-expanding prostheses always cover the coronary ostium, and therefore may hinder future access. The objective of this research was to evaluate the incidence, safety and feasibility of CAG/PCI in patients with prior self-expanding TAVR valves. Methods Among 2170 patients (age 82 ± 6 years, 43% male) who underwent TAVR with Corevalve or Evolut prostheses, as part of the Italian CoreValve ClinicalService® framework (data from 13 Italian centers), the occurrence of CAG/PCI following TAVR and periprocedural characteristics were examined. Results During median follow-up of 379 days, 41 patients (1.9%) required CAG and/or PCI (total 46; 16 CAG, 14 PCI, 16 both PCI/CAG). 56.5% of the procedures were performed under emergency/urgency settings. Left system coronary angiography was successfully performed in most cases (28/32, 87.5%), while right coronary angiography was successful only in 50.0% (16/32). PCI procedures (20 for left system, 3 for right system, 4 for graft) were successfully performed in 93.3% (28/30) of the procedures. No CAG/PCI procedure-related complications including prosthesis dislodgment or coronary ostium dissection occurred. Conclusions CAG and PCI procedures following CoreValve TAVR is safe and mostly feasible, although the success rate of selective right coronary angiography was relatively low when compared to the left system. Further investigations are required to explore this issue.

Transcatheter aortic valve replacement determined a paradigm shift in the treatment of high-risk patients with severe symptomatic aortic valve stenosis. Notwithstanding the impressive results of the first-generation prostheses, a fast-paced technological evolution is taking place to overcome their limitations, in particular the vascular access damage and the paravalvular leak. Nowadays, with the availability of several different devices, the expert operator can select the right prosthesis for the specific anatomical and clinical situation. As ‘One does not fit all’, the ‘Tailored TAVR Approach’ we describe will conceivably become the future of this therapy.

From the first quarter of 2014, a new generation of transcatheter valves (Fig. 8.1) has CE mark approval for clinical use in Europe and under scrutiny for FDA approval in the United States. These new valves aim to overcome or to reduce the major limitations of first-generation valves (Edwards XT and CoreValve) as paravalvular leak, vascular complications, cardiac rhythm disturbances, and stroke. We describe below the technical features and the first clinical results of the new transfemoral devices.

Background Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. Methods Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. Results Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p=0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. Conclusion In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning.

Patient Initials or Identifier Number LMR ### Relevant Clinical History and Physical Exam 49 years, female cardiovascular risk factors: former smoker comorbidities: multifactorial anemia 2014: NSTEMI → PCI +DES in obtuse marginal 2017: aspecific thoracic pain → coronary CT scan →

Vitamin K antagonists have been the only available orally active anticoagulants for decades. Although effective, their numerous limitations have driven the introduction of new oral anticoagulants (NOAs) that showed effectiveness at fixed doses without the need for routine coagulation monitoring. However, the safety and efficacy observed in controlled clinical trials may be hard to translate in clinical practice. Clinical conditions as well as drug interactions may considerably impact on patient outcomes. Moreover, the inability to monitor the pharmacological activity of NOAs and the absence of any antidote in the setting of bleeding or emergent invasive procedures may limit their use. Vitamin K antagonists will be still used in many circumstances, including patients with an optimal control of the INR, with mechanical heart valves, and other indications for which these new agents have not been investigated. Nevertheless, these new agents will reduce the burden of anticoagulation management at the patient as well as Health Care level.

Background— Severe pulmonary hypertension (PH) is considered to negatively affect the outcome after transcatheter aortic valve replacement. However, a clear understanding of the pattern, evolution, and clinical impact of different grades of PH in this setting is lacking. Methods and Results— A total of 990 consecutive patients were enrolled in 6 high-volume centers and analyzed as follows: group 1, systolic pulmonary artery pressure (sPAP) 60 mm Hg (218 patients; 22%). At 1 month, mortality rate did not differ across the groups. When compared with groups 1 and 2, patients in group 3 had a higher-rate of New York Heart Association 3 to 4 (26% versus 12% and 10%), and a higher-rate of hospitalization for heart failure (7% versus 3% and 3%). At 1 year, when compared with patients in group 1, patients in group 2 and 3 had both a higher overall mortality (hazard ratio [HR], 1.5 [1.3–3.2]; P =0.01 and HR, 2.3 [1.8–2.8]; P =0.001) and a higher cardiac mortality (HR, 1.3 [1.1–2.1]; P =0.01 and HR, 1.7 [1.3–2.5]; P =0.002). After 1 month, the sPAP decreased ≥15 mm Hg in 32% and 35% of the patients in groups 2 and 3. Baseline sPAP >60 mm Hg (HR, 1.6 [1.1–2.3]; P =0.03) and, in a larger extent, a persistent severe PH after 1 month (HR, 2.4 [1.5–2.8]; P =0.004), independently predicted 1-year mortality, whereas the 1-month reduction of the sPAP did not. Conclusions— The persistence of severe PH after transcatheter aortic valve replacement is a stronger predictor of 1-year mortality than baseline severe PH. The early reduction of sPAP is not associated with a reduced mortality. The benefit of transcatheter aortic valve replacement in terms of quality of life is substantial in patients with and without a reduction of sPAP at early follow-up.

Background: Vit-K antagonists are the therapy of choice to prevent thromboembolic events due to atrial fibrillation since many years. New oral anticoagulants (NOA) showed encouraging results vs. warfarin but there are no data directly comparing different NOA. We performed an adjusted indirect meta-analysis. Methods: Randomized controlled trials (RCTs) were searched. Efficacy end points were the cumulative rate of thomboembolic stroke (TES) and systemic embolism (SE). Main safety end point was the rate of hemorrhagic stroke (HS). Results: Three RCTs (50578 patients) were included. Overall, NOA were comparable to warfarin according to the cumulative risk of TES and SE, as well as for TES alone. NOA were associated with a reduced rate of SE [OR 0.64 (0.44, 0.94], P = 0.02]. Compared to warfarin, NOA were associated with a significantly reduced risk of HS [OR 0.43 (0.34, 0.55), P 0.05). Rivaroxaban showed superiority in the prevention of SE. Dabigatran 150 mg/twice daily was associated with the largest reduction in the risk of HS vs. warfarin and vs. other NOA. Overall mortality was quite comparable across NOA. Conclusions: Overall superiority of NOA over warfarin is largely influenced by the reduction of HS. Dabigatran 150 mg/twice daily seems to have the best risk/benefit profile.

This report describes the case of previous type-A aortic dissection treated with the placement of a termino-terminal prosthesis, which developed a large peri-prosthetic pseudoaneurysmatic sac, detected by CT, performed 2 years after the surgery. This raised the suspicion of a communication between the pseudoaneurysmatic sac and the aortic lumen, but was not able to show it directly. Transthoracic echocardiography confirmed the presence of the fistula, showing a systo-diastolic color Doppler jet signal connecting these two structures.The complementary role of these two diagnostic techniques allowed a complete evaluation of this complex pathology.

Background— Conduction disturbances are relatively common after transcatheter aortic valve implantation. Previous data demonstrated an adverse impact of persistent left bundle-branch block (LBBB) after surgical aortic valve replacement. It is unclear whether new-onset LBBB may also impact the prognosis of patients after transcatheter aortic valve implantation. Methods and Results— Among 1060 patients treated with a CoreValve Revalving System transcatheter aortic valve implantation between October 2007 and April 2011 in high-volume centers in Italy, we analyzed those without LBBB or pacemaker at admission (879 patients [82.9%]). We further excluded those who underwent permanent pacemaker implantation within 48 hours after the procedure (61 patients [7%]), for a final study population of 818 patients. Among them, 224 patients (group A; 27.4%) developed a persistent LBBB and the remaining 594 (group B; 72.6%) did not. Clinical characteristics were similar between groups. A low implantation was significantly more frequent in group A (15% versus 9.8%, P =0.02). No patients were censored before 1 year (median follow-up period 438 days, interquartile range 174–798 days). Survival analyses and inherent log-rank tests showed that LBBB was not associated with higher all-cause mortality, cardiac mortality, or hospitalization for heart failure at 30 days or 1 year. At 30 days, but not at 1 year, group A had a significantly higher rate of pacemaker implantation. Conclusions— In this registry of high-volume centers, persistent LBBB after CoreValve Revalving System transcatheter aortic valve implantation showed no effect on hard end points. On the other hand, LBBB was associated with a higher short-term rate of pacemaker implantation.

Background— Little is known of the prognostic significance of mitral regurgitation (MR) on transcatheter aortic valve replacement (TAVR), the impact of TAVR on MR severity, and the variables associated with possible post-TAVR improvement in MR. We evaluated these issues in a multicenter registry of patients undergoing CoreValve Revalving System–TAVR. Methods and Results— Among 1007 consecutive patients, 670 (66.5%), 243 (24.1%), and 94 (9.3%) presented with no/mild, moderate, and severe MR, respectively. At 1 month after TAVR, patients with severe or moderate MR showed comparable mortality rates (odds ratio, 1.1; 95% confidence interval [95% CI], 0.7–1.55; P =0.2), but both were significantly higher compared with patients with mild/no MR (odds ratio, 2.2; 95% CI, 1.78–3.28; P P =0.02, respectively). One-year mortality was also similar between patients with severe and those with moderate MR (hazard ratio, 1.4; 95% CI, 0.94–2.4; P =0.06) and still significantly higher compared with patients with mild/no MR (hazard ratio, 1.7; 95% CI, 1.2–3.41; P P =0.03, respectively). Severe pulmonary hypertension, atrial fibrillation, and MR more than mild, but not an improvement of ≥1 grade in MR severity, were independent predictors of mortality at 1 year. At 1 year, an improved MR was observed in 47% and 35% of patients with severe and moderate MR, respectively. The rate of low implantation was consistent across groups with improved, unchanged, or worsened MR. A functional type of MR and the absence of severe pulmonary hypertension and atrial fibrillation independently predicted the improvement in MR severity. Conclusions— Baseline MR greater than mild is associated with higher mortality after CoreValve Revalving System–TAVR. A significant improvement in MR was more likely in patients with functional MR and without severe pulmonary hypertension or atrial fibrillation. The improvement in MR did not independently predict mortality.

We appreciate the interest of Prinzen et al about our article,1 but some of their comments need to be addressed. Prinzen et al analyzed a mixed population of patients treated with CoreValve or Edwards Sapien prostheses.2 Of note, their different influence on the cardiac conduction system is well known,3 with the CoreValve being more prone to determine conduction disturbances as a consequence of the larger frame. Accordingly, we decided to specifically focus on the CoreValve, pooling >800 patients, which is more than double the population considered by Prinzen et al. It is clear that the internal and external validity (ie, the extent of systematic biases and the generalizability of the results) are highly affected by the sample size. Prinzen et al excluded patients who underwent pacemaker implantation within 30 days after transcatheter aortic valve replacement, which, in our opinion, makes little …

ARTICLE Sir, The new era of oral anticoagulation has begun, at least for those patients requiring anticoagulation but showing a suboptimal international normalized ratio control. The comments from Drs Harenberg and Lip suggest a different interpretation of available information but actually highlight the difficulty of discriminating the truth among a huge amount of data. The same amount of data they successfully contributed to provide, as being part of several trials published over the last …

Little evidence is available on antithrombotic strategies after transcatheter aortic valve implantation (TAVI). We aimed to evaluate the use and clinical impact of different antithrombotic regimens after TAVI. Patients with severe aortic stenosis undergoing TAVI with CoreValve™ (Medtronic, MN)

Aims Arterial access selection is crucial during transcatheter aortic valve implantation. When traditional femoral access has been deemed unfeasible the left subclavian artery has been used successfully. In cases where even the latter was ineligible, we opted, despite the lack of any data, for the right subclavian approach. We hereby present the results of the first series available. Our aim was to evaluate the feasibility and performance of the CoreValve ReValving System (CRS) implantation via the right subclavian artery in patients with contraindication to femoral and left subclavian accesses. Methods and results Among 300 patients who have undergone CRS implantation, 70 (23%) have been treated via the subclavian approach, 10 via the right subclavian artery and 60 via the left. Demographic features were quite similar except for the presence of significant left subclavian disease in all patients treated via the right subclavian artery. The success rate was 100% for both groups. At 30-day follow-up, there was no significant difference in terms of all-cause mortality and cardiac mortality between right vs. left subclavian approach (0% vs. 6.6% and 0% vs. 6.6%, respectively). Consistent results were observed at a mean follow-up of 12±7.9 months (all-cause mortality: 10% vs. 15%). Incidences of new AV block requiring PM implantation were also statistically equivalent. Conclusions CRS implantation via the right subclavian artery was as feasible and safe as the left subclavian approach. It poses very particular technical issues but should be considered when more conventional approaches are inadequate in order to provide patients with a further chance to be treated effectively.