Impact of balloon post-dilation on valve durability and long-term clinical outcomes after self-expanding transcatheter aortic valve implantation.

BACKGROUND: Balloon post-dilation (BPD) is a widely adopted strategy to optimize acute results of TAVI, with a positive impact on both paravalvular leak and mean gradients. On the other hand, the inflation of the balloon inside prosthetic leaflets may damage them increasing the risk of structural valve deterioration (SVD). Furthermore, the impact of BPD on long-term clinical outcomes and valve hemodynamics is yet unknown. AIMS: To evaluate the impact of BPD on valve durability and long-term clinical outcomes in patients undergoing self-expanding transcatheter valve implantation (TAVI). METHODS: Echocardiographic and clinical data from the ClinicalService (a nation-based data repository and medical care project) were analyzed. Patients were divided into two groups, those who underwent BPD after TAVI and those who did not. Coprimary endpoints were all-cause death and SVD. Cumulative incidence functions for SVD were estimated. RESULTS: Among 1835 patients included in the study, 417 (22.7%) underwent BPD and 1418 (77.3%) did not undergo BPD. No statistically significant differences at 6-year follow-up were found between groups in terms of all-cause mortality (HR: 1.05, 95% CI: 0.9-1.22; p = 0.557) and SVD (2.1% vs. 1.4%, p = 0.381). In addition, BPD did not predispose to higher risk of cardiovascular death, myocardial infarction, valve thrombosis, and endocarditis at 6-year follow-up. CONCLUSIONS: BPD following TAVI with a self-expanding prosthesis does not seem to be associated with an increased risk of adverse clinical outcomes or SVD at 6-year follow-up.

Lumped-parameter model as a non-invasive tool to assess coronary blood flow in AAOCA patients.

Anomalous aortic origin of the coronary artery (AAOCA) is a rare disease associated with sudden cardiac death, usually related to physical effort in young people. Clinical routine tests fail to assess the ischemic risk, calling for novel diagnostic approaches. To this aim, some recent studies propose to assess the coronary blood flow (CBF) in AAOCA by computational simulations but they are limited by the use of data from literature retrieved from normal subjects. To overcome this limitation and obtain a reliable assessment of CBF, we developed a fully patient-specific lumped parameter model based on clinical imaging and in-vivo data retrieved during invasive coronary functional assessment of subjects with AAOCA. In such a way, we can estimate the CBF replicating the two hemodynamic conditions in-vivo analyzed. The model can mimic the effective coronary behavior with high accuracy and could be a valuable tool to quantify CBF in AAOCA. It represents the first step required to move toward a future clinical application with the aim of improving patient care. The study was registered at Clinicaltrial.gov with (ID: NCT05159791, date 2021-12-16).

Morphological Changes of Anomalous Coronary Arteries From the Aorta During the Cardiac Cycle Assessed by IVUS in Resting Conditions.

BACKGROUND: Anomalous aortic origin of coronary artery (AAOCA) with intramural segment is associated with risk of sudden cardiac death, probably related to a compressive mechanism exerted by the aorta. However, the intramural compression occurrence and magnitude during the cardiac cycle remain unknown. We hypothesized that (1) in end diastole, the intramural segment is narrower, more elliptic, and has greater resistance than extramural segment; (2) the intramural segment experiences a further compression in systole; and (3) morphometry and its systolic changes vary within different lumen cross-sections of the intramural segment. METHODS: Phasic changes of lumen cross-sectional coronary area, roundness (minimum/maximum lumen diameter), and hemodynamic resistance (Poiseuille law for noncircular sections) were derived from intravascular ultrasound pullbacks at rest for the ostial, distal intramural, and extramural segments. Data were obtained for 35 AAOCA (n=23 with intramural tract) after retrospective image-based gating and manual lumen segmentation. Differences between systolic and end-diastolic phases in each section, between sections of the same coronary, and between AAOCA with and without intramural tract were assessed by nonparametric statistical tests. RESULTS: In end diastole, both the ostial and distal intramural sections were more elliptical (P<0.001) than the reference extramural section and the correspondent sections in AAOCA without intramural segment. In systole, AAOCA with intramural segment showed a flattening at the ostium (-6.76% [10.82%]; P=0.024) and a flattening (-5.36% [16.56%]; P=0.011), a narrowing (-4.62% [11.38%]; P=0.020), and a resistance increase (15.61% [30.07%]; P=0.012) at the distal intramural section. No-intramural sections did not show morphological changes during the entire cardiac cycle. CONCLUSIONS: AAOCA with intramural segment has pathological segment-specific dynamic compression mainly in the systole under resting conditions. Studying AAOCA behavior with intravascular ultrasound during the cardiac cycle may help to evaluate and quantify the severity of the narrowing.

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project.

Background: A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown. Aim: We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR. Materials and methods: The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Results: Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases. Conclusion: After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality. Clinical trial registration: [https://clinicaltrials.gov], identifier [NCT04500964].

Myocardial infarction with non-obstructive disease and anomalous coronary origin: look for the common in the uncommon.

Management of congenital coronary artery anomalies (CAA) is not standardized due to the variety of conditions included and their rare prevalence. Detection of CAA during myocardial infarction with non-obstructive coronary arteries (MINOCA) may induce clinicians to address the patient for surgery as CAA is not included in any algorithm1,2 for the management of MINOCA and American Association for Thoracic Surgery evidence-based guidelines suggest surgical repair for patients with anomalous aortic origin of a coronary artery and symptoms compatible with myocardial ischaemia.3 We present the case of a 35-year-old man with an anomalous origin of left coronary artery from right Valsalva sinus with pre-pulmonic course detected during urgent coronary angiography for suspected myocardial infarction. Stress cardiac magnetic resonance did not show signs of ischaemia at high-dose dobutamine but did reveal a recent myocarditis. This clinical case highlights the need for accurate risk stratification in CAA especially when confounding clinical scenarios co-exist.

In-Hospital Outcomes and Predictors of Paravalvular Leak and Deep Implantation With the Evolut R 34-mm Device: A Comparison With Smaller Evolut R Sizes.

PURPOSE: 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. METHODS: 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. RESULTS: 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; p < 0.001) 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 LVOT>27 mm being predictive specifically for Evolut-R 34 mm (AUC:0.66; p = 0.024). CONCLUSIONS: TAVR with Evolut-R 34 mm and Evolut-R 23/26/29 mm showed comparable in-hospital outcome. Aortic angulation >60° and LVOT >27 mm were predictive respectively of ≥moderate PVL and deep implantation specifically in Evolut-R 34 mm patients.

Impact of Nodular Calcifications in the Aortic Annulus and Left Ventricular Outflow Tract on TAVI Outcome with New-Generation Devices.

Background: The impact of nodular calcifications in left ventricular outlow tract (LVOT) and aortic annulus on the procedural outcome of transcatheter aortic valve implantation (TAVI) with new-generation devices is yet to be elucidated. Similarly, computational simulations may provide a novel insight into the biomechanical features of TAVI devices and their interaction with nodular calcifications. Methods: This retrospective single-center study included 232 patients submitted to TAVI with Evolut-R (53.4%), Portico (33.6%) and Lotus (13.0%) devices with available preoperative computed tomography (CT) angiography and evidence of nodular calcifications in aortic annulus and/or LVOT. Calcification severity was defined ≥ moderate in presence of at least two nodules or one nodule ≤ 5 mm. Three virtual simulation models of aortic root presenting a nodular calcification of increasing size were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. Results: At least moderate calcifications were found in 123 (53.0%) patients, with no sex differences. Among the ≥ moderate calcification group, lower device success rate was evident (87.8% vs. 95.4%; p = 0.039). Higher rates of ≥ moderate paravalvular leak (PVL) (11.4% vs. 3.7%; p = 0.028) and vascular complications (9.8% vs. 2.8%; p = 0.030) were also observed. Among the Evolut-R group, higher rates of at ≥ moderate PVL (12.1%) were observed compared to Portico (3.8%; p = 0.045) and Lotus (0.0%; p = 0.044) groups. Calcification of both annulus and LVOT (odds ratio [OR] 0.105; p = 0.023) were independent predictors of device success. On computational simulations, Portico exhibited homogeneous stress distribution by increasing calfications and overall a larger paravalvular orifice areas compared to Evolut-R and Lotus. Evolut-R showed higher values of average stress than Portico, although with a more dishomogeneous distribution leading to greater paravalvular orifice areas by severe calcifications. Lotus showed overall small paravalvular orifice areas, with no significant increase across the three models. Conclusions: At least moderate nodular calcifications in the annulus/LVOT region significantly affected TAVI outcome, as they were independent predictors of device success. Lotus and Portico seemed to perform better than Evolut-R as for device success and ≥ moderate PVL. Computational simulations revealed unique biomechanical features of the investigated devices in terms of stent compliance and radial force.

Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project.

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.

Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bio prostheses 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.

Improved transfemoral accessibility and positioning of the Portico transcatheter heart valve with the new FlexNav delivery system.

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.

Impact of aortic angle on transcatheter aortic valve implantation outcome with Evolut-R, Portico, and Acurate-NEO.

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.

One-year safety and efficacy profile of transcatheter aortic valve-in-valve implantation with the portico system.

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 <21 mm in 71.4% of cases. Device success rate were 69.6% with 14 (25%) patients showing a residual gradient ≥20 mmHg, 2 (3.6%) a PVL ≥ moderate and 1 (1.8%) required a second THV implantation due to device embolization. At 1-year follow-up 5 patients (8.9%) died whereas moderate SVD was reported in 2 (3.6%). Patients with a post-procedural mean gradient ≥20 mmHg showed a significantly higher rate of CV hospitalization (21.4% vs. 2.4%, p = .02) whereas no differences in procedural and 1-year outcomes were noticed according to true ID diameter or degeneration mode. Chimney stenting (ChT) was performed in 23 (41%) patients without significant differences in procedural and 1-year outcomes compared to non-ChT group. CONCLUSIONS: TAVI-ViV with Portico valve was associated with good procedural and 1-year outcomes, even in patients with features of high procedural and anatomical complexity.

Incidence, Technical Safety, and Feasibility of Coronary Angiography and Intervention Following Self-expanding Transcatheter Aortic Valve Replacement.

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 ±â€¯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.

[Epidemiology of stroke and cerebral protection in patients undergoing transcatheter aortic valve replacement]. / Epidemiologia e prevenzione dell'ictus in pazienti sottoposti ad impianto transcatetere di valvola aortica.

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.

Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison.

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.

The failing right heart: implications and evolution in high-risk patients undergoing transcatheter aortic valve implantation.

AIMS: 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. METHODS AND RESULTS: 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., TAPSE <10 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], p<0.001, 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], p<0.001, and HR 1.9 [1.5-2.7], p=0.02), respectively. Pulmonary hypertension >60 mmHg (HR 1.5 [1.1-2.2], p=0.03), AF (HR 1.6 [1.1-2.4], p=0.01), creatinine clearance <30 mL/min (HR 1.92 [1.3-2.5], p=0.003), LVEF <30% (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. CONCLUSIONS: 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.

Persistence of Severe Pulmonary Hypertension After Transcatheter Aortic Valve Replacement: Incidence and Prognostic Impact.

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) <40 mm Hg (346 patients; 35%); group 2, sPAP 40 to 60 mm Hg (426 patients; 43%); and group 3, 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.

Transcatheter aortic valve replacement-state of the art and a glimpse to the future: 'the Tailored Approach'.

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.