Carmelo Sgroi

5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.

OBJECTIVES The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). BACKGROUND There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. METHODS Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria. RESULTS All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported. CONCLUSIONS TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.

Early discharge after transfemoral transcatheter aortic valve implantation

Background The aim of this study was to assess the feasibility and the safety of early discharge (within 72 h) after transfemoral transcatheter aortic valve implantation (TAVI) and to identify baseline features and/or peri-procedural variables, which may affect post-TAVI length-of-stay (LoS) duration. Methods and results Patients discharged within 72 h of TAVI (early discharge group) were compared with consecutive patients discharged after 3 days (late discharge group). Propensity-matched cohorts of patients with a 2:1 ratio were created to better control confounding bias. Among 465 patients, 107 (23.0%) were discharged within 3 days of the procedure. Multivariable regression analysis of unmatched patients demonstrated that baseline New York Heart Association (NYHA) class IV (OR: 0.22, 95% CI 0.05 to 0.96; p=0.045) and any bleeding (OR: 0.31, 95% CI 0.74 to 0.92; p=0.031) were less likely to be associated with early discharge after TAVI. Conversely, the year of procedure (OR: 1.66, 95% CI 1.25 to 2.20; p<0.001) and the presence of a permanent pacemaker (PPM) before TAVI (OR: 2.80, 95% CI 1.36 to 5.75; p=0.005) were associated with a higher probability of early discharge. In matched populations, patients in the early discharge group reported lower incidence of in-hospital bleeding (7.9% vs 19.4%, p=0.014), major vascular complications (2.3% vs 9.1%, p=0.038) and PPM implantation (7.9% vs18.5%, p=0.021), whereas after discharge, at 30-day, no significant differences were reported between groups in terms of death (2.2% vs 1.7%, p=0.540), bleeding (0.0% vs 1.1%, p=0.444), PPM implantation (1.1% vs 0.0%, p=0.333) and re-hospitalisation (1.1% vs 1.1%, p=1.000). Conclusions Early discharge (within 72 h) after transfemoral TAVI is feasible and does not seem to jeopardise the early safety of the procedure, when performed in a subset of patients selected by clinical judgement. Patients undergoing TAVI in unstable haemodynamic compensation and patients experiencing bleeding after the procedure demonstrated to be poorly suitable to this approach, whereas increasing experience in post-TAVI management was associated with a reduction of LoS.

Outcomes of Redo Transcatheter Aortic Valve Replacement for the Treatment of Postprocedural and Late Occurrence of Paravalvular Regurgitation and Transcatheter Valve Failure

Background—Transcatheter aortic valves can degenerate in a manner similar to surgical bioprostheses. Methods and Results—Clinical and echocardiographic outcomes of patients who underwent redo transcatheter aortic valve replacement (TAVR) procedures >2 weeks post procedure were collected from 14 centers. Among 13 876 patients, 50 (0.4%) underwent redo TAVR procedure at participating centers. Indications for redo TAVR were moderate–severe prosthetic aortic valve stenosis (n=10, 21.7%), moderate–severe central prosthetic aortic valve regurgitation (n=13, 28.3%), and moderate–severe paraprosthetic aortic valve regurgitation (n=25, 50.0%). The index TAVR was most commonly a Medtronic CoreValve (N=38, 76.0%), followed by Edwards SAPIEN-type valves (n=12, 24.0%) and Portico (n=1, 2.0%). The redo TAVR device was most commonly a CoreValve/Evolut R (n=29, 58.0%), followed by a SAPIEN-type valve (n=20,40.0%) or a Boston Lotus valve (n=1, 2.0%). In 40 patients (80.0%), redo TAVR was performed using the identical device type or that of the succeeding generation. Valve performance was uniformly good after redo TAVR (mean transvalvular gradient post redo TAVR: 12.5±6.1 mm Hg). At hospital discharge, all patients remained alive, with 1 nondisabling stroke (2.0%) and 1 life-threatening bleed (2.0%). Permanent pacemaker implantation was required in 3 out of 35 patients without a prior pacemaker (8.6%). Late survival was 85.1% at a median follow-up of 1589 days (range: 31–3775) after index TAVR and 635 days (range: 8–2460) after redo TAVR. Conclusions—Redo TAVR for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter aortic valve prosthesis failure seems to be safe, and it is associated with favorable acute and midterm clinical and echocardiographic outcomes.

Optimized Screening of Coronary Artery Disease With Invasive Coronary Angiography and Ad Hoc Percutaneous Coronary Intervention During Transcatheter Aortic Valve Replacement

Background— We sought to describe an optimized approach to coronary artery disease (CAD) screening and management in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and Results— When invasive coronary angiography showed CAD, the treatment strategy and completeness of revascularization was determined based on coronary anatomy. TAVR was performed in the same setting if percutaneous coronary intervention (PCI) was uncomplicated; otherwise TAVR was postponed. A total of 604 patients undergoing CAD screening at the time of TAVR procedure were prospectively included in this study. Severe CAD was found in 136 patients (22.5%). Among patients with severe CAD, 53 patients (8.8%) underwent uncomplicated PCI. After PCI, TAVR was postponed in 2 patients (0.3%). In 83 patients (13.8%), coronary angiography showed severe CAD that was left untreated. After TAVR, all-cause and cardiovascular 30-day mortality rates were 2.4% and 1.4%, respectively. Disabling stroke, myocardial infarction, and life-threatening bleeding occurred in 0.5%, 0.8%, and 4.0% of patients, respectively. Acute kidney injury II or III rate was 3.3%. At 2 years, all-cause mortality rate was 14.1%. Disabling stroke and myocardial infarction occurred in 2.5% and 1.8% of patients, respectively. Patients undergoing TAVR and PCI in the same session had similar rate of the composite of death, disabling stroke, and myocardial infarction when compared with patients without CAD, and patients with severe CAD left untreated (TAVR+PCI: 10.4%; severe CAD left untreated: 15.4%; no-CAD: 14.8%; P=0.765). Conclusions— In patients undergoing TAVR, screening of CAD with invasive coronary angiography and ad hoc PCI during TAVR is feasible and was not associated with increased periprocedural risks. PCI followed by TAVR in the same session had similar outcomes than TAVR in which PCI was not performed.

Comparison of aortic root anatomy and calcification distribution between Asian and Caucasian patients who underwent transcatheter aortic valve implantation.

The current transcatheter aortic valve implantation (TAVI) devices have been designed to fit Caucasian and Latin American aortic root anatomies. We evaluated the racial differences in aortic root anatomy and calcium distribution in patients with aortic stenosis who underwent TAVI. We conducted a multicenter study of 4 centers in Asia and Europe, which includes consecutive patients who underwent TAVI with preprocedural multidetector computed tomography. Quantitative assessment of aortic root dimensions, calcium volume for leaflet, and left ventricular outflow tract were retrospectively performed in a centralized core laboratory. A total of 308 patients (Asian group, n = 202; Caucasian group, n = 106) were analyzed. Compared to Caucasian group, Asian group had smaller annulus area (406.3 ± 69.8 vs 430.0 ± 76.8 mm(2); p = 0.007) and left coronary cusp diameter (30.2 ± 3.2 vs 31.1 ± 3.4 mm; p = 0.02) and lower height of left coronary artery ostia (12.0 ± 2.5 vs 13.4 ± 3.4 mm; p <0.001). Of baseline anatomic characteristics, body height showed the highest correlation with annulus area (Pearson correlation r = 0.64; p <0.001). Co-existence of lower height of left coronary artery ostia (<12 mm) and small diameter of left coronary cusp (<30 mm) were more frequent in Asian group compared with Caucasian group (35.6% vs 20.8%; p = 0.02). In contrast, there were no differences in calcium volumes of leaflet (367.2 ± 322.5 vs 359.1 ± 325.7 mm(3); p = 0.84) and left ventricular outflow tract (8.9 ± 23.4 vs 10.1 ± 23.8 mm(3); p = 0.66) between 2 groups. In conclusion, judicious consideration will be required to perform TAVI for short patients with lower height of left coronary artery ostia and small sinus of Valsalva.

Predictors for Paravalvular Regurgitation After TAVR With the Self-Expanding Prosthesis: Quantitative Measurement of MDCT Analysis.

Paravalvular regurgitation (PVR) remains a major concern of transcatheter aortic valve replacement (TAVR) as it is associated with poorer outcomes. PVR after TAVR results from several factors, including, device undersizing, aortic valve calcification, and prosthesis malposition [(1)][1]. We sought

New insights on acute expansion and longitudinal elongation of bioresorbable vascular scaffolds in vivo and at bench test: A note of caution on reliance to compliance charts and nominal length

We performed systematic optical coherence tomography (OCT) analyses after bioresorbable vascular scaffolds (BVS) implantation in a “real world” setting aiming at evaluating scaffold expansion and longitudinal integrity.

Usefulness of the logistic clinical SYNTAX score for predicting 1-year mortality in patients undergoing percutaneous coronary intervention of the left main coronary artery

To externally validate the logistic clinical SYNTAX in patients undergoing percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA).

3-year outcomes of self-expanding Corevalve prosthesis - The Italian Registry

Transcatheter aortic valve implantation (TAVI) is an emerging, catheter-based technology that allows for implantation of a prosthetic valve without open heart surgery for the treatment of severe aortic stenosis (AS) (1). The recently published Placement of Aortic Trans Catheter Valves (PARTNER) randomized controlled trial cohort B demonstrated that TAVI remarkably reduced the mortality, as compared with standard therapy, in patients deemed unsuitable for surgery (2). In addition, PARTNER cohort A results showed that 1-year outcomes after TAVI compare favorably with surgical aortic valve replacement (3). While a number of large single-arm registries demonstrated encouraging short and mid-term effectiveness of TAVI (4-9), there is a paucity of data on the benefits of this technique at longer follow-up (10-11). The lack of evidence for the long-term durability of currently available transcatheter heart valves is one of the main issues preventing TAVI being used in younger and lower risk patients. The present study evaluated the medium- to long-term outcomes of an early cohort undergoing transcatheter aortic valve implantation with the third generation (18-Fr) CoreValve prosthesis (CRS) (Medtronic Incorporation, MN, USA) at 12 centers across Italy, with all patients evaluated by follow-up at a minimum of 3 years from the procedure. Device success, cardiovascular death, peri-procedural and spontaneous myocardial infarction, strokes, bleeding, combined safety and efficacy endpoints and echocardiographic criteria post-TAVI were defined according to the Valve Academic Research Consortium (VARC) (12). The mean age of the entire population was 80.9±6.1 years. All patients had severe symptomatic AS [mean aortic valve area (AVA) 0.61±0.23 cm2]. Overall, the population was at high surgical risk with a predicted 30-day mortality of 24.0±13.5% by Logistic EuroScore and 11.4±9.9% by STS-mortality score. Trans-femoral access was used in 172 patients (95.0%); in 9 patients (5.0%) where the trans-femoral approach was not feasible, a trans-subclavian approach was employed. Clinical follow-up was available in 178 patients (98.3%) at a mean of 41±3 months (range 36 to 51 months) after TAVI. All-cause mortality rates at 1, 2, and 3 years were 23.6%, 30.3%, and 34.8%, respectively (Figure 1A). Cardiovascular mortality rates at 1, 2, and 3 years were 11.2%, 12.1%, and 13.5%, respectively (Figure 1B). The bulk of late mortality in this high-risk cohort was due to significant comorbidities and was generally unrelated to aortic valve disease. The actuarial rate of a composite of death, major stroke, myocardial infarction and life-threatening bleeding was 30.1% at 1 year, 36.5% at 2 years, and 40.3% at 3 years. Patients with renal insufficiency did not present significant differences in term of 30-day mortality (3.8% vs. 7.8%; P=0.332) compared with those without, whereas they had higher mortality at 3-year follow-up (51.0% vs. 29.2%, P=0.007); on the other hand, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already at 30 days (21.6% vs. 2.8%; P<0.001) and this result was sustained at 3-year follow-up (62.2% vs. 28.4%; P<0.001). Moreover, the study demonstrated excellent durability, no evidence of structural valvular failure, and preserved hemodynamics. No changes in valve area and transvalvular gradients were documented, which were generally different to those in previously published surgical series that reported on bioprosthetic valves in the aortic position. Patients showed significant improvement in functional state, which appeared to be preserved over time. Postprocedural aortic regurgitation was generally mild and did not appear to worsen over time. Echocardiographic study at follow-up also demonstrated no evidence of valve fracture, deformation, or valve migration. Figure 1 All-cause (A) and cardiovascular (B) mortality after TAVI among the entire population The central finding of this study is that 3-year survival after TAVI with the CRS prosthesis amounted to 65%. This data is not surprising, given the baseline risk profile of the subjects undergoing the procedure during the early TAVI experience which was extremely high. Therefore, patients died during follow-up either because of their comorbidities or secondary to conditions associated with advanced age, as proved by the 13% of cardiovascular death rate at 3 years, which mostly occurred during the first month after TAVI, due to procedural complications. This poses an obvious challenge for longer-term real effectiveness of TAVI in such a population and raises questions about whether this procedure could improve long-term results in lower-risk patients, as actually suggested by recent reports (9,13). According to our findings, since three out of five patients died due to non-cardiovascular causes at a median of 11 months, almost half of those patients should be denied the procedure in agreement of 2008 European position statement on TAVI, which pointed out that this procedure should not be performed in patients whose life expectancy is less than 1 year (14). Therefore, in the future it will be crucial to identify patient populations that can derive most advantage from the application of this technology in the perspective of a cost-benefit ratio. Overall, when used in patients who are deemed to be poor surgical candidates, transcatheter aortic valve implantation appears to offer an adequate and lasting resolution of symptomatic aortic stenosis.

Managing Bioabsorbable Vascular Scaffold Failure: Combined Scaffold Restenosis and Late-Acquired Coronary Aneurysm Treated With Self-Expandable Stent

A 50-year-old man underwent coronary angiography for stable angina with evidence of chronic total occlusion of the right coronary artery. Chronic total occlusion recanalization was performed with implantation of 4 overlapping bioresorbable vascular scaffolds. At 12 months, elective follow-up coronary angiography documented an asymptomatic 90% in-scaffold restenosis of the right coronary artery located in the mid portion of a newly late-acquired aneurysm. To address the challenging issue introduced by the varying reference vessel diameters, a self-expandable stent was implanted.