CoreValve Prosthesis Research Articles

Immediate outcomes of transcatheter aortic valve implantation in patients with horizontal aorta

Background: Transcatheter aortic valve implantation (TAVI) is an effective and safe procedure for severe aortic stenosis. Increased aortic root angulation is an important anatomical feature that may cause technical difficulties and negatively affect immediate and long-term outcomes.Objective: To evaluate immediate outcomes of TAVI in patients with increased aortic root angulation.Methods: Our retrospective single-center study included 412 patients with severe aortic stenosis who underwent TAVI using self-expanding bioprostheses from 2015 to 2022. Patients with aortic root angulation ≥ 49° were included in group 1 (n = 200), and those with aortic root angulation < 49° comprised group 2 (n = 212).Results: The mean age of the patients was 75.2 ± 7.2 years. In a subgroup with the first-generation CoreValve prosthesis and a ≥ 49° angle, we observed moderate aortic regurgitation significantly more often (7.4% vs 0.0%, P = .010) and technical success significantly less often (90.1% vs 98.9%, P = .010) compared with a similar subgroup with a < 49° angle. In subgroups with CoreValve Evolute R and ACURATE neo prostheses, there were no significant differences in terms of the mentioned parameters. Independent predictors of technical failure were the aortic root angle [OR for each degree increase: 0.44, 95% CI: 0.30-0.63, P < .001], no postdilation [OR: 5.0, 95% CI: 1.33-20.00, P = .074], indexed mass of the left ventricular myocardium [OR: 1.02, 95% CI: 1.01-1.03, P = .003], and higher implantation relative to the aortic annulus [OR for every 1 mm decrease in implantation depth: 0.44, 95% CI: 0.30-0.63, P < .001].Conclusion: Increased aortic angulation ≥ 49° negatively affected the technical success of TAVI only in patients with the first-generation CoreValve prostheses. Independent predictors of technical failure in TAVI were the aortic root angle, no postdilation, indexed mass of the left ventricular myocardium, and higher implantation relative to the aortic annulus. Received 9 January 2023. Revised 10 May 2023. Accepted 30 May 2023. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. BadoianData collection and analysis: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. BadoianStatistical analysis: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. BadoianDrafting the article: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, S.N. Manukian, A.Yu. Tsydenova, M.A. MakhmudovCritical revision of the article: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, S.N. Manukian, A.Yu. Tsydenova, M.A. MakhmudovFinal approval of the version to be published: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, S.N. Manukian, A.Yu. Tsydenova, M.A. Makhmudov

Complexity assessment and technical aspect of coronary angiogram and percutaneous coronary intervention following transcatheter aortic valve implantation.

BackgroundPerforming selective coronary angiogram (CA) and percutaneous coronary intervention (PCI) post transcatheter aortic valve implantation (TAVI) may be challenging with various success rates of coronary ostia engagement.MethodsAmong all patients who underwent CA and/or PCI after TAVI from our single center TAVI registry, ostia cannulation success was reported according to the quality of ostia engagement and artery opacification, and was classified as either selective, partially selective or non-selective but sufficient for diagnosis.ResultsAmong the 424 consecutive TAVI procedures performed at the aforementioned institution, 20 (4.7%) CA were performed in 19 (4.5%) patients at a median time of 464 days post TAVI (25–75% IQ: 213–634 days). CA were performed in 7 CoreValve, 9 Evolut R, 1 Evolut PRO and 2 Edwards Sapien 3 devices. Transradial vascular approach was attempted in 9 procedures (45%, right n = 6 and left n = 3) and was successful in 8 (40%) patients. A total of 20 left main artery ostium cannulation were attempted leading to a diagnostic CA in all of them with selective engagement in 65%. Engagement of the right coronary artery in 2 out of 15 attempted cases failed due to a low ostium in conjunction with a high implantation of a CoreValve prosthesis. 11 PCI (55% of CA) including 2 left main lesions were performed. In 4 patients (36.4% of the PCI), an extension catheter was required to engage the left main. All planned PCI were successful.ConclusionsPost TAVI CA and PCI are challenging but feasible even after supra-annular self-expandable valve implantation.

Valve-in-Valve Implantation of Medtronic CoreValve Prosthesis in Patients With Failing Bioprosthetic Aortic Valves: Mid-term Outcomes From the Italian CoreValve Clinical Service Project.

We evaluated the acute and two-year safety and efficacy of using the Corevalve, Evolut R, and Evolut PRO valves for treating failed surgical bioprosthesis from the Italian CoreValve Clinical Service Project. Valve-in-valve (ViV) TAVR is an emerging treatment option for failed surgical bioprosthesis. Choice of transcatheter valve is an important determinant of procedural and clinical outcomes, however, longer-term data are lacking. The Clinical Service Project is a national clinical data repository evaluating the use of implantable devices across Italy. The present multi-center analysis includes consecutive patients who underwent ViV-TAVR with the Medtronic CoreValve series between October 2008 to June 2019. Evaluated endpoints included rates of overall mortality, cardiovascular mortality, myocardial infarction, and cerebrovascular accidents at 2-year follow-up. Procedural success, complications, and echocardiographic outcomes were reported according to VARC-2 criteria. A total of 139 patients (mean age, 80 ± 7 years; 47.5% male; mean STS score, 10.0 ± 9.7%) underwent ViV-TAVR with CoreValve (28.5%), Evolut R (68.6%), and Evolut Pro (2.9%) valves. Device success was achieved in 68% and acute coronary obstruction requiring PCI was observed in 4 patients (2.9%). Moderate PVL was observed in 3.7% and 2.8% of patients at 30-day and 2-year follow-up and moderate structural valve degeneration seen only 5 patients (3.6%). All-cause and cardiovascular mortality were 3.6% and 2.9% at 30 days, respectively, and 20.6% and 10.2% at 2-year follow-up. This real-world nationwide analysis demonstrates the acute and longer-term safety and efficacy of using the self-expanding Medtronic THV for ViV-TAVR.

Association between fragmented QRS and post-procedural rhythm disturbances in patients who underwent transcatheter aortic valve implantation with CoreValve system

Abstract Background Transcatheter aortic valve implantation (TAVI) is a less invasive and safe therapeutic alternative in patients who are at very high surgical risk or in whom there are contraindications to open surgery (1,2).On the other hand, life threatening complications including stroke, paravalvular leak, and rhythm disturbances that require permanent pacing still persist (3).Fragmented QRS (fQRS) is defined as RSR' pattern with different morphologies of QRS complexes with or without the Q wave on a resting 12-lead electrocardiogram (ECG) (4). Purpose In this study, we examined association between fQRS and post-procedural rhythm disturbances and the need for permanent pacing in patients who underwent TAVI with CoreValve system. Methods We analysed standard 12-lead electrocardiographic recordings of 124 consecutive patients in whom a CoreValve prosthesis (MedronicInc; Minneapolis; USA) was implanted. Patients having bundle branch block or QRS duration ≥120 ms in baseline ECG recordings and patients with prior history of permanent pacing were excluded from the study. We examined 12-lead ECGs before and after procedure along with one month and six month follow up. We documented QRS fragmentation and post-procedural rhythm disturbances. Results Based on our data, 39 out of 71 patients (54.9%) with fQRS developed temporary rhythm disturbances. However, only 4 out of 29 patients (13.7%) without fQRS developed temporary rhythm disturbances.The difference between two groups in terms of temporary rhythm disturbances was statistically significant (59.4% vs 13.7%, p=0.002). Furthermore, 28 out of 71 patients (39.4%) with fQRS and 1 out of 29 patients (3.4%) without fQRS developed permanent rhythm disturbances, (39.4% vs 3.4%, p<0.001).The difference in permanent rhythm disturbances was also maintained in 1st month and 6th-month follow-ups (37.1% vs 0%, p<0.0001, and 38.7% vs 0%; p<0.0001). According to our data, presence of QRS in anterior derivations was the only independent factor associated with development of post-procedural rhythm disturbances (p<0.05). Conclusion Our data showed an increased risk for development of new-onset LBBB and AV blocks following TAVI in patients whose baseline ECG recordings demonstrated fQRS. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Ankara Ataturk Training and Research Hospital

Association between fragmented QRS and postprocedural rhythm disturbances in patients who underwent transcatheter aortic valve implantation.

According to recent studies, the rate of atrioventricular block requiring permanent pacing in patients following transcatheter aortic valve implantation varied between 5.7% and 42.5%. Fragmented QRS is a useful marker of myocardial scar and can predict adverse cardiac events. In this study, we examined association between f ragmented QRS and postprocedural rhythm disturbances and the need for permanent pacing in patients who underwent transcatheter aortic valve implantation. In this study, we examined association between fragmented QRS and postprocedural rhythm disturbances and the need for permanent pacing in patients who underwent transcatheter aortic valve implantation' sentence is enough for it. We retrospectively analyzed standard 12-lead electrocardiographic recordings of 124 consecutive patients in whom a CoreValve prosthesis was implanted. We examined 12-lead electrocardiogram before and after procedure along with one- and six-month follow-up. We documented QRS fragmentation and postprocedural rhythm disturbances. There was a significant increase in the frequency of left bundle branch block, (21.1 versus 0%, p<0.05) and the incidence of atrioventricular blocks requiring permanent pacing (21.1 versus 0%, p<0.05) following transcatheter aortic valve implantation in patients whose preprocedural electrocardiogram recordings revealed fragmented QRS compared to those without fragmented QRS. Based our collected data, the presence of QRS fragmentation in anterior derivations was the only independent factor associated with postprocedural rhythm disturbances (B-value 0.217; OR 0.805; 95%CI 0.136-4.78; p=0.004). Our data showed an increased risk for the development of new-onset left bundle branch block and atrioventricular blocks following transcatheter aortic valve implantation in patients whose baseline electrocardiogram recordings demonstrated QRS fragmentation.

Long-term outcomes after transcatheter aortic valve replacement in nonagenarians: a multicenter age-based analysis.

To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR). We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (≥90 vs. 80-89 years vs. 70-79 vs. <70 years) and to compare outcomes up to 4 years after TAVR. At 4 years, survival estimates showed no difference in terms of overall survival [Kaplan-Meier estimates (KM est.) 49.9 vs. 58.1% vs. 57.0 vs. 69.3%; Plogrank = 0.28] among the four groups. After 2 years from the procedure, landmark analysis showed an age-based difference in overall survival (KM est. 63.8 vs. 75.0% vs. 75.1 vs. 88.7%; Plogrank = 0.025) but no difference in terms of survival from cardiovascular death (KM est. 87.8 vs. 87.4% vs. 86.1 vs. 96.1%; Plogrank = 0.43). Finally, age itself was not correlated with overall mortality at 4 years (hazard ratio 1.06, 95% confidence interval 0.86-1.30, P = 0.591). TAVR with self-expanding CoreValve and Evolut prostheses was demonstrated to have good long-term outcomes, regardless of the patient's age. At 4 years, no difference in overall mortality was reported among age-based groups, while a higher overall mortality was reported in nonagenarians after 2 years from the procedure. TAVR showed good long-term outcomes even in nonagenarian patients, and it could be the therapy of choice for selected elderly patients.

Coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement with medtronic self-expanding prosthesis: Insights from correlations with computer tomography

ObjectivesWe aim to describe the feasibility, challenges, success rates and techniques utilized in coronary angiography (CA) and percutaneous coronary intervention (PCI) in patients post transcatheter aortic valve replacement (TAVR). BackgroundCA and PCI after TAVR are becoming increasingly encountered in clinical practice. There have been technical difficulties reported in re-accessing the coronary arteries through the self-expanding CoreValve prosthesis. MethodsFrom January 2012 to November 2017, 672 patients who underwent TAVR with a self-expanding prosthesis were retrospectively reviewed and those who had a CA and/or PCI post TAVR were analysed. Clinical characteristics, angiographic and procedural details were obtained. A subgroup of patients had computed tomographic angiography (CTA) post TAVR to evaluate positions of the coronary ostia relative to the self-expanding prosthesis. Study endpoint was successful selective engagement of coronary ostia for CA and PCI. ResultsThirty-two patients (4.8%) had attempted 46 CA and 26 PCI after TAVR with a self-expanding valve. Mean age was 85.2 years and 41% were females. Selective left and right coronary angiography using standard catheters could be achieved in 50% and 28% of cases respectively. Successful PCI was performed in 25 cases (96%); however, significant technique modification was required in 64% of cases. CTA in 9 patients confirmed the difficulty in coronary re-access was due to a combination of the sealing skirt relationship to coronary ostia and sinotubular junction as well as commissural post orientation and significant native leaflet calcification. ConclusionsCA and PCI post TAVR with self-expanding CoreValve is technically challenging but feasible with modification of standard techniques.

Global and regional myocardial function and outcomes after transcatheter aortic valve implantation for aortic stenosis and preserved ejection fraction.

To investigate the effects of transcatheter aortic valve implantation (TAVI) on early recovery of global and segmental myocardial function in patients with severe symptomatic aortic stenosis and preserved left ventricular ejection fraction (LVEF) and to determine if parameters of deformation correlate with outcomes. The echocardiographic (strain analysis) and outcome (hospitalizations because of heart failure and mortality) data of 62 consecutive patients with preserved LVEF (64.54 ± 7.97%) who underwent CoreValve prosthesis implantation were examined. Early after TAVI (5 ± 3.9 days), no significant changes in LVEF or diastolic function were found, while a significant drop of systolic pulmonary artery pressure (PAP) occurred (42.3 ± 14.9 vs. 38.1 ± 13.9 mmHg, P = 0.028). After TAVI global longitudinal strain (GLS) did not change significantly, whereas significant improvement in global mid-level left ventricular (LV) radial strain (GRS) was found (-16.71 ± 2.42 vs. -17.32 ± 3.25%; P = 0.33; 16.57 ± 6.6 vs. 19.48 ± 5.97%, P = 0.018, respectively). Early significant recovery of longitudinal strain was found in basal lateral and anteroseptal segments (P = 0.038 and 0.048). Regional radial strain at the level of papillary muscles [P = 0.038 mid-lateral, P < 0.001 mid-anteroseptum (RSAS)] also improved. There was a significant LV mass index reduction in the late follow-up (152.42 ± 53.21 vs. 136.24 ± 56.67 g/m, P = 0.04). Mean follow-up period was 3.5 ± 1.9 years. Parameters associated with worse outcomes in univariable analysis were RSAS pre-TAVI, LV end-diastolic diameter after TAVI, relative wall thickness, and mitral E and E/A after TAVI. Global and regional indices of myocardial function improved early after TAVI, suggesting the potential of myocardium to recover with a reduced risk for clinical deterioration.

P5986Clinical outcomes of age in patients with severe aortic stenosis treated with Transcatheter Aortic Valve Replacement

Abstract Transcatheter Aortic valve Replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement for patients considered at high or prohibitive operative risk. It is widely known the short and mid-term outcomes, however, is limited about long-term outcomes in according to age. The aim of this study was to determine the survival and the clinical outcomes on based of age. after TAVR with the CoreValve prosthesis. Methods From April 2008 to December 2017, the CoreValve and Sapiens 3 prosthesis were implanted in 667 patients with symptomatic severe aortic stenosis with deemed high risk on base to age, &lt;80 years and ≥80 years old Results The mean age in patients &lt;80 compared with ≥80 years, was 73.6±7 vs. 83.4±2.8 years and the logistic EuroSCORE and STS score were 16.3±11% vs. 18.1±11%. In-hospital mortality was 3.4%, and the combined endpoint of death, vascular complications, myocardial infarction, majopr bleeding or stroke had a rate of 18.3%. The late mortality (beyond 30 days) was 40.5%. When compared both groups, there were no differences for the presence of threatening bleeding 3.5% vs. 3.6% (HR = 1.033 [IC95% 0.452–2.360], p=0.557), myocardial infarction4.2% vs. 2.9% (HR = 0.67 [IC95% 0.290–1,530], p=0.0.226), stroke 8.9% vs. 9.4% (HR = 1.067 [IC95% 0.625–1.821], p=0.814) and mortality 44.5% vs. 41.1% (HR=0.971388 [IC95% 0.639–1.188], p=0.214) and there was difference in between groups in hospitalizations for heart failure 13.8% vs. 7.7% (HR = 1.374 [IC95% 1.037–1.821], p=0.008. Survival at 1, 2, 3, 4, 5 were similar in both groups (86.9% vs. 89.8%, 78.4 vs. 78.3%, 65.5 vs. 72.5%, 57.9% vs. 62.8% and 51.1 vs. 52.8%&gt;; log Rank 0.992, p=0.319), respectively, after a mean follow-up of 43.9±27 months. Conclusions TAVR is associated with significant survival benefit throughout 3.2 years of follow-up. Survival during follow-up was similar in patients with &lt;80 compared with ≥80 years old.

Changes in Mitral Annular Displacement and Other Echocardiographic Parameters After TAVI: Philippine Experience

OBJECTIVE: The aim of this study was to describe the use of speckle-tracking echocardiography derived mitral annular displacement (STE-MAD) in the assessment of left ventricular (LV) systolic function in patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI). METHODS: This was a retrospective case series that included patients with severely symptomatic AS who underwent TAVI who had baseline transthoracic 2D echocardiography (TTE) and one TTE study ≤ 30-day post-TAVI. In all patients who qualified, STE MAD was then measured in apical 4- and 2-chamber views. RESULTS: Out of 105 severely symptomatic AS patients who underwent TAVI, 33 patients fulfilled the inclusion criteria. Majority of included patients were male (64%). The average age was 77.15 ± 8.46 years. The most commonly implanted valves were the Lotus valve (39%), the CoreValve prosthesis (33%) and the CoreValve Evolut R prosthesis (28%). There were improvements in the STE-MAD measurements of post-TAVI patients, ranging from 1.433–2.384 mm and 1.935–2.845 mm in the 2C and 4C views, respectively. There was good interobserver and intraobserver agreement in measurements pre- and post-TAVI. Two patients (6.1%) died and seven patients (21.2%) experienced heart failure during the 30-day follow-up period. CONCLUSIONS: STE-MAD is useful in assessing improvements in systolic function in patients with severe AS post-TAVI.

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

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. 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. 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. 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.

Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk.

The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years. Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria. Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test P=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm2 versus 1.2 cm2, P<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P<0.001) and a new pacemaker (43.7% versus 8.7%, P<0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes. These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR. URL: https://clinicaltrials.gov. Unique identifier: NCT01057173.

TAVR in Patients with Left Ventricular Assist Device: Case Report and Literature Review

ABSTRACT The use of left ventricular assist devices (LVADs) as a bridge-to-transplant or destination therapy in patients with end-stage heart failure has been increased during the last years. However, a potential obstacle to the success of long-term LVAD support is represented by the development of de novo aortic valve lesions leading to aortic regurgitation or, more rarely, to commissural fusion and stenosis. The paper addresses the main pathophysiological factors in the development of aortic valvular regurgitation in patients with LVAD and describes an updated review of all transcatheter aortic valve replacement (TAVR) cases to treat aortic regurgitation currently available. We also report on a case of a patient with a Jarvik 2000 requiring transcatheter aortic valve replacement for aortic regurgitation. The procedure was performed using a 31-mm CoreValve prosthesis. The first check after the positioning of the prosthetic valve revealed a good result. However, a second 10-min check, performed as per protocol at the end of the procedure, showed a sliding of the prosthetic valve downward toward the apex of the left ventricle with a severe periprosthetic regurgitation. Therefore, a second 31-mm CoreValve was deployed within the previous valve prosthesis and a 10-min check revealed a stable position and a mild residual leak. The management of LVAD patients with aortic regurgitation remains challenging. Although transcatheter techniques have demonstrated feasibility in these patients, technical adjustments and further expertise are needed to optimize these procedures.

RF11 CALCIUM LOADING AS RISK FACTOR FOR POST IMPLANTATION LEAKAGE IN TAVI PROCEDURES

Abstract Background and Aims: To assess aortic valve calcification with a reproducible method and the performance of different prostheses in relation to the occurrence of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) in a large single-center cohort. Methods: We retrospectively analyzed preoperative contrast-enhanced CT scans of patients who underwent TAVI in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve (AV), in the left ventricular outflow tract (LVOT) and device-landing zone (DLZ). Multivariate analysis was performed to evaluate the risk factors for intraoperative PVL. Results: 539 patients were included in the study (Edwards SapienXT, n = 192; Edwards Sapien3, n = 206; Medtronic CoreValve EvolutR, n = 44; Symetis Acurate, n = 97). Median calcium volume in the DLZ was 757 mm3 (IQR 734.2), with no significant differences among the four prosthesis groups. None of the patients had severe PVL. The overall incidence of mild-to-moderate PVL was 15.8%. On multiple linear regression analysis, DLZ calcification, non-coronary cusp in LVOT calcification, transapical access, and use of the CoreValve and Acurate prostheses were found to be independently associated with PVL. In contrast, degree of oversizing, and use of Sapien3 were independently associated with a lower incidence of PVL. Conclusions: DLZ and non-coronary cusp in LVOT calcification are independently associated with PVL occurrence after TAVI. Among prostheses, Sapien3 seems to be associated with a lower incidence of PVL regardless of calcium volume.

The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement: Matched Comparison of the Evolut PRO and Evolut R

ObjectivesThe aim of this study was to investigate the hemodynamic and clinical performance of the Evolut PRO compared with its direct predecessor, the Evolut R. BackgroundRecently, the newest commercially available generation of the self-expandable Medtronic CoreValve prosthesis, the CoreValve Evolut PRO, was introduced to the market. This prosthesis is based on the previous Evolut R model and specifically designed to mitigate paravalvular leakage. Because of the design changes, the Evolut PRO needs a larger sheath size (16-F vs. 14-F). MethodsPatients receiving either the Evolut R (n = 148) or the Evolut PRO (n = 74) from September 2015 to January 2018 were compared in a 2:1 fashion after propensity score matching. Baseline characteristics, cardiovascular imaging, and pre- and periprocedural outcomes were prospectively collected and assessed. ResultsBoth cohorts represent a high-risk, real-world collective with increased perioperative mortality risk (logistic European System for Cardiac Operative Risk Evaluation score, Evolut R vs. Evolut PRO: 24.7 ± 13.7% vs. 25.1 ± 12.5%; p = 0.881). Procedural success was 100%, and the mean transvalvular pressure gradient was substantially reduced (Evolut R vs. Evolut PRO: 7.9 ± 3.9 mm Hg vs. 7.5 ± 3.5 mm Hg; p = 0.348). Mild paravalvular leakage was observed in 16.2% of Evolut R patients and in 14.9% of Evolut PRO patients (p = 0.794). In the Evolut R group, moderate aortic regurgitation was documented in 2 patients (Evolut R vs. Evolut PRO: 1.4% vs. 0%; p = 1.000). No differences regarding clinical parameters, such as major bleeding events (Evolut R vs. Evolut PRO: 1.4% vs.1.3%; p = 0.868) and vascular complications were observed. ConclusionsBoth prostheses show excellent hemodynamic performance with a low incidence of paravalvular leakage and comparable clinical outcomes.

Incidence, Predictors, and Midterm Clinical Outcomes of Myocardial Injury After Transcatheter Aortic-Valve Implantation.

Our aim was to assess the clinical effects of myocardial injury after transcatheter aortic-valve implantation (TAVI). Between October 2013 and July 2016, 157 patients underwent TAVI with Sapien XT, Sapien 3, or CoreValve prostheses at our institute. Of these, 130 patients for whom the transapical approach was not used were included in this study. Myocardial injury was defined as a peak troponin I level of ≥1.5 ng/mL within 48 hours after TAVI. We evaluated the predictors of myocardial injury and compared the clinical outcomes of 82 patients classified as the myocardial injury group and 44 patients classified as the non-myocardial injury group. The patients were aged 85 ± 6 years. Myocardial injury occurred in 82 patients (65.1%). Age (per 1 increase) (odds ratio [OR]: 1.11, 95% confidence interval [CI]: 1.01-1.22, P = 0.041), female sex (OR: 3.88, 95% CI: 1.23-12.22, P = 0.021), valve type (Sapien XT; OR: 4.22, 95% CI: 1.15-15.47, P = 0.03, Core valve; OR: 18.12, 95% CI: 2.86-114.59, P = 0.002), balloon aortic valvuloplasty as a bridge therapy (OR: 0.10, 95% CI: 0.02-0.42, P = 0.002), and left ventricular end-diastolic volume (LVEDV) (per 1 increase) (OR: 0.97, 95% CI: 0.95-0.99, P = 0.003) were associated with myocardial injury in a multivariate model. The myocardial injury group did not have a higher rate of midterm (365-day) mortality (log-rank test P = 0.57) than the non-myocardial injury group on Kaplan-Meier analysis. Myocardial injury after TAVI was not associated with midterm mortality.

Risk factors for paravalvular leak after transcatheter aortic valve replacement

ObjectiveTo assess risk factors for paravalvular leak (PVL) after transcatheter aortic valve implantation in a large single-center cohort, including measurement of aortic valve calcification using a reproducible method. MethodsWe retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent transcatheter aortic valve implantation in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve, left ventricular outflow tract, and device landing zone. ResultsOverall, 539 patients were included in the study who had experience with 4 prothesis types (SapienXT [Edwards Lifesciences, Irvine, Calif] [n = 192], Sapien3 [Edwards Lifesciences] [n = 206], CoreValve EvolutR [Medtronic, Minneapolis, Minn] [n = 44], and Acurate [Symetis, Ecublens, Switzerland] [n = 97]). Median calcium volume in the device landing zone was 757 mm3, with no significant differences among the 4 prosthesis groups. None of the patients had severe PVL. The overall incidence of mild-to-moderate PVL was 15.8% (95% confidence interval [CI], 12.8%-19.1%). On multivariate logistic regression, device landing zone calcification (P = .00006; odds ratio for an increase of 100 mm3, 1.08; 95% CI, 1.04-1.13) and use of the CoreValve (P = .0028; odds ratio, 4.1; 95% CI, 1.6-10 with SapienXT as reference) prosthesis were found to be associated with mild or greater PVL. In contrast, degree of oversizing (P = .002; odds ratio, 0.97; 95% CI, 0.95-0.99), and use of Sapien3 (P = .00005; odds ratio, 0.23; 95% CI, 0.11-0.47 with SapienXT as reference) were associated with a lower incidence of mild or greater PVL. ConclusionsAortic calcification volume in the device landing zone is associated with residual PVL after transcatheter aortic valve implantation. When taking calcification into account, the balloon-expandable prosthesis Sapien3 seems to be associated with a lower incidence of PVL.

Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis

The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p = 0.27), major stroke (2.6% vs 2.2%, p = 0.54), major vascular complications (6.9% vs 8.0%, p = 0.37), major bleeding (24.4% vs 26.1%, p = 0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p = 0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics.

Transcatheter Aortic Valve Replacement: OPTIMIZING OUTCOMES FOR HEALTHY RECOVERY.

Transcatheter aortic valve replacement (TAVR) has been approved in the United States for intermediate and high-risk patients with severe symptomatic aortic stenosis. More than 80 000 TAVR procedures have been performed in the United States and the number is growing every year. Two valve designs are approved in the United States including the balloon expandable Edwards Sapien prosthesis and self-expanding CoreValve prosthesis. The PARTNER trial of the Sapien valve, involving patients who were considered inoperable, reported a 19% absolute risk reduction in mortality compared with medical therapy, with a number needed to treat of 5. Randomized controlled trials in patients with high and intermediate risk of inhospital mortality based on the Society of Thoracic Surgeons score showed noninferiority of TAVR compared with surgical aortic valve replacement. Major complications associated with TAVR include a 2% to 3% risk of stroke at 30 d, 8% to 25% risk of permanent pacemaker implantation depending on valve design, and 6% risk of major vascular complications. There are some concerns regarding valve durability as this technology is extended to younger patients with lower risk. Five-year follow-up data from the initial PARTNER trials noted appropriate valve performance and hemodynamics in survivors; however, longer follow-up is required to assess the true incidence of structural deterioration. Approximately one-third of TAVR patients are transferred to a transitional care facility after TAVR, and more than 50% of the patients are frail. Cardiac rehabilitation has been reported to be safe in post-TAVR patients and was associated with significant improvements in exercise capacity, functional independence, and frailty.

Development and Application of a System Based on Artificial Intelligence for Transcatheter Aortic Prosthesis Selection.

IntroductionThe interest in Expert systems has increased in the medical area. Some of them are employed even for diagnosis. With the variability of transcatheter prostheses, the most appropriate choice can be complex. This scenario reveals an enabling environment for the use of an Expert system. The goal of the study was to develop an Expert system based on artificial intelligence for supporting the transcatheter aortic prosthesis selection.MethodsThe system was developed on Expert SINTA. The rules were created according to anatomical parameters indicated by the manufacturing company. Annular aortic diameter, aortic area, aortic perimeter, ascending aorta diameter and Valsalva sinus diameter were considered. After performing system accuracy tests, it was applied in a retrospective cohort of 22 patients with submitted to the CoreValve prosthesis implantation. Then, the system indications were compared to the real heart team decisions.ResultsFor 10 (45.4%) of the 22 patients there was no concordance between the Expert system and the heart team. In all cases with discordance, the software was right in the indication. Then, the patients were stratified in two groups (same indication vs. divergent indication). The baseline characteristics did not show any significant difference. Mortality, stroke, acute myocardial infarction, atrial fibrillation, atrioventricular block, aortic regurgitation and prosthesis leak did not present differences. Therefore, the maximum aortic gradient in the post-procedure period was higher in the Divergent Indication group (23.9 mmHg vs. 11.9 mmHg, P=0.03), and the mean aortic gradient showed a similar trend.ConclusionThe utilization of the Expert system was accurate, showing good potential in the support of medical decision. Patients with divergent indication presented high post-procedure aortic gradients and, even without clinical repercussion, these parameters, when elevated, can lead to early prosthesis dysfunction and the necessity of reoperation.