Outcomes of three different new generation transcatheter aortic valve prostheses.

AIMS: To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) using three different new-generation devices. BACKGROUND: Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head-to-head comparisons are available among these devices. METHODS: This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF-TAVI for native, severe aortic stenosis using a new-generation transcatheter aortic valve (TAV) with a preprocedural multi-detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS: The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30-day all-cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more-than-trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (plog-rank = 0.534). CONCLUSIONS: TAVI using new-generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more-than-trace PVR. At 1-year, MACCE rates were similar among the three groups.

Immediate outcome after sutureless versus transcatheter aortic valve replacement.

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate-severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1-5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.

Predictors and safety of next-day discharge in patients undergoing transfemoral transcatheter aortic valve implantation.

AIMS: The aim of this study was to evaluate predictors and safety of next-day discharge (NDD) after transfemoral transcatheter aortic valve implantation (TF-TAVI) in unselected patients receiving either balloon-expandable or self-expanding devices. METHODS AND RESULTS: From June 2007 to August 2018, 1,232 consecutive patients undergoing TF-TAVI were discharged alive from our institution. They had a mean age of 80.9±5.4 years and an intermediate estimated surgical mortality risk; they received either balloon-expandable (26.1%) or self-expanding prostheses (73.9%). We compared patients discharged within 24 hours from the procedure (n=160, 13.0%) with those discharged later, and accounted for confounding variables through a propensity matching adjustment. After adjustment, no differences in all-cause mortality (1.2% vs 0.0%, for NDD and no-NDD matched groups, respectively, p=0.16) or permanent pacemaker implantation (PPI) after TAVI (0.6% vs 0.6%, respectively) were encountered at 30 days. At one year, no difference in the composite endpoint of all-cause death and heart failure (HF) rehospitalisation was encountered (Kaplan-Meier [KM] estimates 91.9% vs 90.6% for NDD and no-NDD matched groups, respectively, p=0.69). After excluding patients with post-procedural major complications from the unmatched population, prior PPI (OR 2.06, 95% CI: 1.21-3.51; p<0.01) and availability of preprocedural computed tomography angiography (CTA) (OR 1.71, 95% CI: 1.15-2.54; p<0.01) were found to be predictors of NDD after TAVI. CONCLUSIONS: NDD in unselected patients after TF-TAVI using either balloon-expandable or self-expanding devices was demonstrated to be a safe strategy up to one year in the absence of procedural complications. Patients with prior PPI and undergoing preprocedural CTA had a higher chance of NDD.

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study.

OBJECTIVES: The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment. BACKGROUND: Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking. METHODS: RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR. RESULTS: Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01). CONCLUSIONS: Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204).

Long-term Transcatheter Aortic Valve Durability.

Transcatheter aortic valve implantation (TAVI) has become the standard of care for high-risk and inoperable surgical patients and a valid alternative to surgery for low- and intermediate-risk patients with severe, symptomatic aortic stenosis. It is increasingly being used for younger, lower-risk patients, so it is important to ensure the durability for long-term transcatheter aortic valves. The lack of standard definitions of structural valve degeneration (SVD) had made comparison among studies on prosthetic valve durability problematic. The 2017 standardised definitions of SVD by the European Association of Percutaneous Cardiovascular Intervention), the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery, and the 2018 definitions by the Valve In Valve International Data group, has generated an increased uniformity in evaluations. This article examines the potential mechanisms and rates of SVD of transcatheter bioprostheses and the role of redo TAVI as a treatment option.

Pacemaker dependency after transcatheter aortic valve implantation: incidence, predictors and long-term outcomes.

AIMS: The aims of this study were to determine the appropriateness of permanent pacemaker implantation (PPI) after TAVI through an analysis of PM dependency at follow-up, and to assess long-term outcomes of patients undergoing PPI after TAVI. METHODS AND RESULTS: From June 2007 to February 2018, 1,116 consecutive patients without prior PM underwent TAVI in our institution. We assessed the incidence and predictors of PM dependency of patients who underwent PPI within 30 days, and also the six-year outcomes among patients who did not undergo PPI at 30 days. At 30 days, PPI was reported in 145 patients (13.0%). Rates of PM dependency were 35.7%, 35.8% and 33.3% at 1, 6 and 12 months, respectively. Analysing PPI timing, implantation on day 1 was found to be a predictor of PM dependency at six months (OR 20.7 [95% CI: 3.4-126.7]; p=0.001) and 12 months (OR 7.5 [95% CI: 1.4-40.2]; p=0.019). An interaction between PM dependency and the presence of baseline right bundle branch block (RBBB) at six months (pinteraction=0.024) and 12 months (pinteraction=0.028) was reported when PPI was performed on the same day as TAVI. At six years, patients who received a PM at 30 days showed a higher all-cause death rate (KM estimate 41.7% vs 57%; plog-rank=0.034). CONCLUSIONS: Among patients receiving PPI after TAVI, PM dependency rates were about 33-36% at one year. Patients with a baseline RBBB undergoing PPI at day 0 or at day 1 when severe CDs persisted for 24 hours after TAVI, irrespective of baseline CDs, had a higher chance of being PM-dependent at follow-ups. Finally, PPI after TAVI was associated with increased six-year mortality.

Oral Anticoagulant Type and Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of the study was to investigate the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR). BACKGROUND: Non-vitamin K oral anticoagulants (NOACs) are superior to vitamin K antagonists (VKAs) in nonvalvular atrial fibrillation (AF), while their comparative performance among patients in need of OAC undergoing TAVR is underinvestigated. METHODS: The study enrolled 962 consecutive patients who underwent TAVR in 4 tertiary European centers and were discharged on either NOACs (n = 326) or VKAs (n = 636). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding. RESULTS: Mean age and Society of Thoracic Surgeons score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range: 3.0% to 7.3%); 52.5% were women and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, myocardial infarction, and any cerebrovascular event at 1-year after TAVR, was 21.2% with NOACs versus 15.0% with VKAs (hazard ratio [HR]: 1.44; 95% confidence interval [CI]: 1.00 to 2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium bleeds and all-cause mortality were comparable between the NOAC and VKA groups, 33.9% versus 34.1% (HR: 0.97; 95% CI: 0.74 to 1.26; p = 0.838, IPTW-adjusted) and 16.5% versus 12.2% (HR: 1.36; 95% CI: 0.90 to 2.06; p = 0.136, IPTW-adjusted), respectively. CONCLUSIONS: Chronic use of both NOACs and VKAs among patients in need of OAC after TAVR are comparable regarding 1-year bleeding risk. The higher ischemic event rate observed with NOACs needs to be evaluated in large randomized trials.

Incidence of Long-Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement.

Background Long-term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long-term (8-year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement ( TAVR ) who reached at least 5-year follow-up. Methods and Results Consecutive patients with at least 5-year follow-up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/ European Society of Cardiology/European Association for Cardio-Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre- TAVR ) to 10.5±4.5 mm Hg (in-hospital post- TAVR ) ( P<0.001). There was a small, not significant, increase in the transaortic gradient throughout follow-up. Bioprosthetic valve failure was observed in a total of 11 patients (8-year cumulative incidence function: 4.51%; 95% confidence interval , 1.95%-8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8-year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%-5.71%) and 13 patients (8-year cumulative incidence function: 5.87%; 95% confidence interval , 3.06%-9.96%), respectively. Aortic valve reintervention (redo TAVR ) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis. Conclusions In an aged population of patients with symptomatic severe aortic stenosis treated with first-generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.

Clinical Outcomes and Prognosis Markers of Patients With Liver Disease Undergoing Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Analysis.

BACKGROUND: Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients. METHODS AND RESULTS: This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score-matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P=0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P=0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P=0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03-1.17; P=0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47-6.56; P=0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate <60 mL/min and Child-Pugh B or C). CONCLUSIONS: These findings suggested that TAVR is a feasible treatment for severe aortic stenosis in patients with early-stage liver disease or as bridge therapy before a curative treatment of the hepatic condition. Patients with Child-Pugh class B-C, especially in combination with renal impairment, had a very low survival rate, and TAVR should be carefully considered to avoid a futile treatment. These results may contribute to improve the clinical decision-making process and management in patients with liver disease.

Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli: A multicenter study.

INTRODUCTION: Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm CRS with other valve sizes. METHODS: Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31mm and other valve sizes (i.e., 23, 26, and 29mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed. RESULTS: In total, 2069 patients (n=169 [8%] in the 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p=0.030) and device-success (88.5% vs. 97.1%, p=0.016), longer procedural time (120 [80-180] min. vs. 90 [60-120] min., p<0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p=0.027). The rates of permanent pacemaker implantation in the 31mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p=0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31mm valve group through 2-years (3.8% vs. 13.5%, respectively, p=0.014). CONCLUSIONS: The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term 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.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

AIMS: Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. METHODS AND RESULTS: Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). CONCLUSIONS: Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

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.

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.

Comparison of suture-based vascular closure devices in transfemoral transcatheter aortic valve implantation.

AIMS: The aim of this study was to compare outcomes with the use of two haemostasis strategies after transfemoral transcatheter aortic valve implantation (TAVI) - one Prostar® vs. two ProGlide® devices (Abbott Vascular Inc., Santa Clara, CA, USA). METHODS AND RESULTS: This was a retrospective study enrolling consecutive patients undergoing fully percutaneous transfemoral TAVI in our centre (Ferrarotto Hospital, Catania, Italy) from January 2012 to October 2014. All patients were dichotomised according to the vascular closure device (VCD) used for common femoral artery haemostasis (Prostar vs. ProGlide). All outcomes were defined according to VARC-2 criteria. The study population encompassed a total of 278 patients. Of these, 153 (55.1%) underwent TAVI using the Prostar, and 125 (44.9%) using two ProGlide devices. Vascular complications occurred in 48 patients (17.3%), being more frequent in the ProGlide group (11.8% vs. 24.0%, p=0.007). Patients who had TAVI using the ProGlide were also more likely to have a higher rate of percutaneous closure device failure (4.6% vs. 12.8%, p=0.013). Percutaneous peripheral intervention was performed in 13.7% and 28.0% of Prostar and ProGlide cases, respectively (p=0.003). CONCLUSIONS: Patients undergoing transfemoral TAVI had significantly lower rates of vascular complications and percutaneous closure device failures when the Prostar was used compared with two ProGlide devices.

Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation).

OBJECTIVES: The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored. METHODS: The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure. RESULTS: The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days. CONCLUSIONS: Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR.