Valve Academic Research Consortium Definitions Research Articles

Transcatheter aortic valve-in-valve implantation in failed stentless bioprostheses.

To compare the safety and efficacy of transcathether aortic valve-in-valve implantation (ViV-TAVI) in degenerated stentless bioprostheses with failed stented valves and degenerated native aortic valves. Little is known about ViV-TAVI in degenerated stentless valves. Out of 45 ViV-TAVI procedures reported in the POL-TAVI registry, 20 failed stentless valves were compared with 25 stented prostheses and propensity-matched with 45 native TAVI cases. The mean follow-up was 633 (95% confidence interval [CI], 471-795) days and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. Patients with degenerated stentless valves were younger (65.6, CI 58-73.1 years vs 75.6, CI 72.2-78 [stented] vs 80.1, CI 78.7-81.6 y. [native], P < 0.001). Implantation was required later after surgery (11.5, CI 8-14.9 years) in the stentless cohort as compared with the stented one (6.2, CI 4.7-7.6 years, P = 0.006). ViV-TAVI in the stentless group was also associated with larger amount of contrast (211, CI 157-266 mL vs 135, CI 104-167 mL [stented] vs 132 (119-145) mL [native], P = 0.022). Using VARC-2 composite endpoints, ViV-TAVI in stentless prostheses was characterized by a lower device success (50% vs 76% in stented vs 88.9% in native TAVI, P < 0.001), but comparable early safety up to 30 days (73.7% vs 84% vs 81.8%, respectively, log-rank P = 0.667) and long-term clinical efficacy beyond 30 days (72.2% vs 72% vs 73.8%, respectively, log-rank P = 0.963). Despite technical challenges and a lower device success, ViV-TAVI in stentless aortic bioprostheses achieves similar safety, efficacy, and functional improvement as in stented or degenerated native valves.

Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: The randomized ATLANTIS trial

BackgroundAntithrombotic treatment regimen following transcatheter aortic valve replacement (TAVR) is not evidence-based. Apixaban, a non-vitamin K direct anticoagulant (NOAC) was shown to be superior to VKA and superior to aspirin to prevent cardioembolic stroke in non-valvular atrial fibrillation. It may have the potential to reduce TAVR-related thrombotic complications including subclinical valve thrombosis along with a better safety than the standard of care. DesignATLANTIS is a multicenter, randomized, phase IIIb, prospective, open-label, superiority study comparing standard of care (SOC Group) versus an apixaban-based strategy (Anti-Xa Group) after successful TAVR (ClinicalTrials.gov NCT 02664649). Randomization is stratified according to the need for chronic anticoagulation therapy for a reason other than the TAVR procedure. In the experimental arm, patients receive 5 mg bid of apixaban or a reduced dose of 2.5 mg bid according to the drug label or when apixaban is combined with antiplatelet therapy. In the control arm, patients receive VKA therapy if there is an indication for oral anticoagulation or antiplatelet therapy alone (single or dual) or the combination of both if needed. The primary study end point is the composite of all-cause death, TIA/stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism, life-threatening, disabling or major bleeding, according to the Valve Academic Research Consortium definitions. ConclusionsATLANTIS tests the superiority of an apixaban-based strategy versus the recommended standard of care strategy to reduce the risk of post-TAVR thromboembolic and bleeding complications in an all comer population.

Effect of aorto-ventricular angulation on procedural success in transcatheter aortic valve replacements with the Lotus Valve system.

To determine the effect of aorto-ventricular angulation (AA) on procedural success with the Lotus Valve system. AA, the angulation of the aortic valve basal plane, may affect the deployment of transcatheter aortic valve replacements (TAVRs). The Lotus Valve system is fully repositionable and delivered on a pre-shaped catheter which may alter the impact of AA on its deployment. The effect of AA on procedural and clinical outcomes with the Lotus valve is unreported. Consecutive patients who underwent transfemoral TAVR with the Lotus Valve system were analyzed. AA was determined on pre-procedural multi-detector computed tomography imaging. Device success, procedural characteristics, and clinical events were assessed according to Valve Academic Research Consortium-2 (VARC2) definitions. One hundred sixty-five patients were analyzed (48% male, mean age 84 years). The mean AA was 47.8 degrees. Patients were, therefore, divided into low AA (AA < 48°) or high AA (AA ≥ 48°). Baseline characteristics were similar in both cohorts. Device success and procedural outcomes were also similar including procedure time, contrast dose, and need to reposition. There was no difference in degree of moderate or greater para-valvular regurgitation (PVR) (0% vs. 3%, P = 0.09). Clinical outcomes of death, stroke, myocardial infarction, and other major VARC2 endpoints were similar. AA did not affect device success or clinical outcome with the Lotus Valve system. The Lotus' unique design features may have mitigated the impact of AA by improving the accuracy, ease of valve positioning, and reducing PVR.

Reporting Clinical Outcomes In Tavi Registries

Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for high surgical risk patients with severe aortic stenosis. However, the fast growth of TAVI has created difficulties in cross-study result comparison. In 2011 and 2013, Valve Academic Research Consortium (VARC) published standardized definitions on reporting endpoints in TAVI studies. The objective of this study is to provide an overview of TAVI registries and the reporting of clinical outcomes based on VARC-2 definitions. A systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients’ characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry’s publications. No publication time restriction was used. 20 TAVI registries were identified in our review with an overall sample size of 12,583 patients. 20 TAVI registries used either EuroScore or Society of Thoracic Surgery Risk Score (STS) or both to record patients’ baseline characteristics and case selection. The 30-day all-cause mortality ranged from 0 to 12.7%. 14 registries reported 30-day cardiovascular mortality, and only 11 registries reported 1-year mortality. Myocardial infarction (MI) should be differentiating into periprocedural MI and spontaneous MI, the author only can identify 11 registries who reported periprocedural MI. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation. Of all 20 TAVI registries, 30% reported 9 of 9 complications, and 55% missed 1-2 complications. VARC and VARC-2 definitions are more and more widely used by TAVI registries. Reporting VARC-2 definitions makes cross-registry comparisons more feasible. Since the introduction of VARC, the number of systematic-review and meta-analysis is dramatically increasing. This transparence will provide better evidence to patients and decision makers such as regulatory bodies, payers and HTA agencies.

FIRST NORTH AMERICAN EXPERIENCE WITH THE SYMETIS TRANSCATHETER AORTIC BIOPROSTHESES FOR THE TREATMENT OF SEVERE AORTIC STENOSIS WITH 1-YEAR FOLLOW UP

Transcatheter aortic valve implantation (TAVI) has become a valuable alternative for the treatment of patients with severe symptomatic aortic stenosis (AS) and deemed not surgical candidates. We present the initial North American experience with the Symetis ACURATE TAVI technology with 1-year follow-up. A total of 112 patients with symptomatic severe AS underwent TAVI using the transapical ACURATE-TA and the transfemoral ACURATE-Neo (Symetis S.A., Ecublens, Switzerland) devises. In-hospital and 30-day outcomes were evaluated and reported according to the Valve Academic Research Consortium-2 definitions. Clinical and echocardiographic follow-up was performed up to 1-year. The mean age was 82.2±7.98. 1 years with a mean logistic-EuroSCORE of 17.92±11.26%. The transapical ACURATE-TA was implanted in 77 patients (68.75), and the transfemoral ACURATE-Neo in 35 patients (31.25%). The procedure was successfully performed in 85 patients. Two patients (1.7%) required an emergency conversion to conventional cardiopulmonary bypass due to valve embolization. There were no coronary obstructions. Residual paravalvular-leak (PVL) was identified in 37 (33%) patients, and evaluated as mild in 36 (32.1%) and moderate in 7(6.25%) patients. The mean peak and mean gradients were 16±8.5 and 8±4.6 mmHg, respectively. 10 (8.9%) patients required a pacemaker implantation. The mean intensive-care unit and length-of-stay were 1±0.9 and 7±5.5 days, respectively. In-hospital mortality was 2.7% (n=3), 30-day mortality was 2.7% (n=3). At a mean follow-up time of 11.5±7.6 months, 10 more patients (8.9%) died with an overall mortality of 14.2% (n=16) at 1 year. Most of the patients were in NYHA class I-II (86.6%). In 41.4% of the patients there was persistent mild PVL and 2.1% a moderate PVL. The rate of readmission to hospital for congestive heart failure was 16.4%. This initial experience with the Symetis ACURATE bioprostheses has demonstrated that this transcatheter valve performs well in a selected subset of patients with comparable or superior short-term results compared to other TAVI devices.

Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes.

Transcatheter aortic valve implantation (TAVI) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis. Given the unique characteristics of Asian populations, questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed. We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions. This prospective study recruited 59 patients from a major academic medical centre in Singapore. The main outcomes were two-year survival rates, peri-procedural complications, symptom improvement, valvular function and assessment of learning curve. Mean age was 76.8 years (61.0% male), mean body surface area 1.6 m2 and mean logistic EuroSCORE 18.7%. Survival was 93.2%, 86.0% and 79.1% at 30 days, one year and two years, respectively. At 30 days post TAVI, the rate of stroke was 1.7%, life-threatening bleeding 5.1%, acute kidney injury 25.0%, major vascular complication 5.1%, and new permanent pacemaker implantation 6.8%. 29.3% of TAVI patients were rehospitalised (47.1% cardiovascular-related) within one year. These composite outcomes were measured: device success (93.2%); early safety (79.7%); clinical efficacy (66.1%); and time-related valve safety (84.7%). Univariate analysis found these predictors of two-year all-cause mortality: logistic EuroSCORE (hazard ratio [HR] 1.07; p < 0.001); baseline estimated glomerular filtration rate (HR 0.97; p = 0.048); and acute kidney injury (HR 5.33; p = 0.022). Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality (HR 14.64; p = 0.008). Despite the unique clinical differences in Asian populations, this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI.

Long-term outcomes and prosthesis performance after transcatheter aortic valve replacement: results of self-expandable and balloon-expandable transcatheter heart valves.

Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariable analysis. Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

BackgroundClinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. ObjectivesThis study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. MethodsThe FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. ResultsMean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. ConclusionsTAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study

Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system. In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions. Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II. This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes. None.

Procedural Characteristics and Outcomes of Transcatheter Aortic Valve Implantation: A Single-Center Experience of the First 100 Inoperable or High Surgical Risk Patients with Severe Aortic Stenosis.

This is the first study of a Taiwanese population reporting transcatheter aortic valve implantation (TAVI) outcomes of the first 100 cases from a single center offering two different transcatheter heart valve technologies via six types of approaches. We herein report the 30-day and one-year outcomes in our first 100 TAVI patients at Taipei Veterans General Hospital. From May 2010 to April 2016, 100 consecutive patients with severe aortic stenosis (AS) who were considered unsuitable or at high risk for surgical aortic valve replacement underwent TAVI. Patient outcomes were classified according to the Valve Academic Research Consortium-2 (VARC-2) definitions. The device performance was assessed using transthoracic echocardiography by independent investigators. The mean patient age was 81.1 years, where 54% were female, and the mean Logistic EuroSCORE was 21.5%. The Medtronic CoreValve was used in 84 patients and the Edwards Sapien or Sapien XT valve (ESV) in 16. The transfemoral approach was the most frequently used route (83%), followed by transapical (9%) access. Overall, there was no procedural death. The VARC-2 outcomes were as follows: device success, 95%; stroke, 1%; major vascular complication, 3%; a need for pacemaker implantation, 5.1%. At discharge, the incidence of postoperative mild, moderate or severe paravalvular leak was 30%, 3% and 0%, respectively. At one year, the all-cause mortality rate was 14.0%, and no valve-related dysfunction was observed. Through multivariable analysis, non-transfemoral access [hazard ratios (HR) 4.81; 95% confidence interval (CI) 1.66-14.09; p = 0.004] and advanced chronic kidney disease (stages 4-5), (HR 3.13; 95% CI 1.07-9.09; p = 0.036) were independently associated with an increased risk of one-year mortality. We demonstrated that TAVI shows good early and mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance in high-risk patients with severe AS.

Association Between Blood Transfusions and 12-Month Mortality After Transcatheter Aortic Valve Implantation.

Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.

Independent Risk Factors Contributing to Acute Kidney Injury According to Updated Valve Academic Research Consortium-2 Criteria After Transcatheter Aortic Valve Implantation: A Meta-analysis and Meta-regression of 13 Studies

This study aimed to examine the risk factors for transcatheter aortic valve implantation (TAVI)-associated acute kidney injury (AKI) according to the AKI definition from the Valve Academic Research Consortium-2 (VARC-2). A meta-analysis. A total of 661 patients with post-TAVI AKI according to the VARC-2 definition and 2,012 controls were included in the meta-analysis. Patients undergoing TAVI were included in this meta-analysis. Multiple electronic databases were searched using predefined criteria. The diagnosis of AKI was based on the VARC-2 classification. The authors found that preoperative New York Heart Association class IV (odds ratio [OR], 7.77; 95% confidence interval [CI], 3.81-15.85), previous chronic renal disease (CKD) (OR, 2.81; 95% CI, 1.96-4.03), and requirement for transfusion (OR, 2.03; 95% CI, 1.59-2.59) were associated significantly with an increased risk for post-TAVI AKI. Furthermore, previous peripheral vascular disease (PVD), hypertension, atrial fibrillation, congestive heart failure, diabetes mellitus, and stroke were also risk factors for TAVI-associated AKI. Additionally, transfemoral access significantly correlated with a reduced risk for post-TAVI AKI (OR, 0.43; 95% CI, 0.33-0.57). The potential confounders, including Society of Thoracic Surgeons Score, the logistic European System for Cardiac Operative Risk Evaluation, aortic valve area, mean pressure gradient, left ventricular ejection fraction, age, body mass index, contrast volume, and valve type, had no impact on the association between the risk factors and post-TAVI AKI. Subgroup analysis of the eligible studies presenting multivariate logistic regression analysis on the independent risk factors for post-TAVI AKI revealed that previous CKD, previous PVD, and transapical access were independent risk factors for TAVI-associated AKI. The current meta-analysis suggested that previous CKD, previous PVD, and transapical access may be independent risk factors for TAVI-associated AKI.

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

IntroductionLittle 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. MethodsConsecutive 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. ResultsIn 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). ConclusionsThe acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.

One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation.

In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p<0.001), closure device failure (0.8% vs. 2.3%, p=0.04), any bleeding (BARC: 36.8% vs. 53.9%, p<0.001; VARC-2: 30.8% vs. 34.9%, p=0.59). Furthermore, one-year mortality was significantly lower in the ProGlide SMCD group, 14.8% vs. 19.5% in the Prostar SMCD group, log-rank p=0.04. However, VARC-2 major vascular complications but not ProGlide use were identified as an independent predictor of one-year mortality (adjusted odds ratio 1.54, 95% CI: 1.01-2.34 and 1.01, 95% CI: 0.65-1.55, respectively). In this analysis, the use of ProGlide SMCD was associated with a reduced risk of vascular and bleeding complications following TAVI compared to Prostar SMCD usage. However, major vascular complications but not ProGlide use did independently predict long-term mortality.

Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study

Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation.

One-Year Outcomes of Transcatheter Aortic Valve Implantation Using the Direct Aortic Approach

The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice. Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory. From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p< 0.01). The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.

Relation Between Clinical Best Practices and 6-Month Outcomes After Transcatheter Aortic Valve Implantation With CoreValve (from the ADVANCE II Study)

Best practices for transcatheter aortic valve implantation with CoreValve include patient screening and valve size selection using multislice computed tomography, adherence to manufacturer recommendations for oversizing, control of implant depth to 6mm or less, and management of conduction disturbances according to international guidelines. The ADVANCE II study implemented these strategies and demonstrated their relation to clinical outcomes. From October 2011 to April 2013, 200 patients with severe aortic stenosis were enrolled, and 194 were implanted. All imaging and electrocardiographic data were analyzed by an independent core laboratory, and adverse events were adjudicated to valve academic research consortium-2 definitions. The mean age was 80.2 ± 6.7years and the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 7.2 ± 6.8% for the enrolled patients. At 6months, all-cause mortality was 9.2%, stroke was 2.6%, and permanent pacemaker implantation was 19.2% for class I and II indications. In patients with implant depth ≤6mm, both mortality and permanent pacemaker implantation were lower than in patients with depth >6mm (2.5% vs 14.5%, p<0.01 and 18.1% vs 31.7%, p= 0.03, respectively). The rate of moderate and severe paravalvular leak was 9.8% at 7days after transcatheter aortic valve implantation, decreasing to 4.3% at 6months (p= 0.02). Valves were significantly more oversized in patients with mild or less paravalvular leak at day 7 compared with those with moderate or severe (15.8 ± 8.0% vs 11.8 ± 4.9%, p= 0.01). In conclusion, findings from the ADVANCE II study reinforce that adherence to best clinical practices improves patient outcomes.

Early and Midterm Clinical and Hemodynamic Outcomes of Transcatheter Valve-in-Valve Implantation: Results From a Multicenter Experience

Transcatheter valve-in-valve (VIV) implantation is an alternative option in inoperable or high-risk patients with prosthetic valve dysfunction. Aim of this retrospective multicenter study was to evaluate early and midterm clinical and hemodynamic outcomes of patients undergoing aortic (VIV-A) and mitral VIV (VIV-M). We analyzed data of 66 procedures performed in 65 patients who underwent VIV procedures in the VIV-A and VIV-M position at 5 Italian institutions from January 2008 to May 2015. VIV-A and VIV-M were 44 (68%) and 22 (32%), respectively; 1 patient underwent combined mitroaortic VIV. Study devices were both balloon-expandable and self-expandable. Outcomes were defined according to the updated Valve Academic Research Consortium definitions. Overall all-cause 30-day mortality was 6% (4patients), and it was 4.5% and 9% in VIV-A and VIV-M, respectively (2 patients in each group). Mean follow-up was 14 ± 14 months. Kaplan-Meier survival of the entire cohort at 1, 2, 3, and 4 years was 84.4% ± 4.9%, 80.5% ± 6%, 74.3 ± 8.1%, and 62% ± 13.2%, respectively. Age (hazard ratio: 1.1; 95% confidence interval: 1.0 to 1.3; p= 0.035) and diabetes (hazard ratio: 7.2, 95% confidence interval: 2.1 to 23.7; p= 0.001) were identified as independent predictors of mortality. Degenerated surgical aortic prostheses with an internal diameter (ID) less than 20 mm had significantly higher gradients if compared to prostheses with ID 21 to 23 mm and greater than 23 mm. After VIV-A, a severe stenosis (mean gradient greater than 35 mm Hg) was detected in 3 (6.8%) cases, all with ID less than 20 mm. VIV provides good early and midterm results in high-risk or inoperable patients with mitral or aortic bioprosthesis dysfunction. Age and diabetes are independently associated with mortality. Size of bioprosthesis ID has a significant impact on postoperative gradients.

Age-Related Differences in 1- and 12-Month Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation (from a Large Multicenter Data Repository)

Scarce data are available on the impact of age on transcatheter aortic valve implantation (TAVI) outcomes. We therefore, analyzed 1,845 consecutive patients from 9 Italian centers who underwent TAVI with the Corevalve Revalving System from September 2007 to March 2014; patients were dichotomized according to their age in the date of the procedure, as follows: 75 to 85 years old and >85 years old. End points were defined according to Valve Academic Research Consortium definitions. In-hospital, 30-day, and 1-year clinical and echocardiographic data were available for 100% of the patients included. Propensity matching was performed. Procedural success rates were high (>94%) and comparable between groups. Although worse baseline renal function was observed in the older group, the incidence of acute kidney injury after procedure was comparable (17.1% and 17.4%, respectively for the 75- to 85- and >85-year-old group, p= 0.877); importantly, >99% of acute kidney injury episodes in both groups were grades 1 and 2. Procedural complications rates were low without between-group differences. In-hospital death (3.7% and 4.6%, p=0.379) and stroke/transient ischemic attack (1.9% and 1.9%, respectively, p= 0.960) were comparable. The 1-year death rates were 14.9% and 17.2% (p= 0.197) in the 75- to 85- and >85-year-old group, respectively. Cardiovascular death was observed in 7.8% and 7% (p= 0.542), while stroke/transient ischemic attack was demonstrated in 5.2% and 4.4% (p= 0.496), respectively. Results were sustained after propensity matching. In conclusion, advanced age did not negatively impact the outcomes of TAVI through 1-year after procedure.

Aortic Angulation Attenuates Procedural Success Following Self-Expandable But Not Balloon-Expandable TAVR

ObjectivesThe aim of this study was to evaluate the impact of increased aortic angulation (AA) on acute procedural success following transcatheter aortic valve replacement (TAVR). BackgroundThe degree of angulation between the aorta and the heart can make accurate positioning of the bioprosthesis during TAVR more demanding, particularly in instances of an extremely angulated or horizontal aortic root. Nonetheless, there are limited data on the impact of AA on the acute success of TAVR. MethodsWe assessed 582 patients who underwent TAVR at our institute and had contrast computed tomography available for AA evaluation. TAVR endpoints, device success, and adverse events were considered according to the Valve Academic Research Consortium-2 definitions. ResultsThe mean angulation of the aorta was 47.3 ± 8.7°. Patients were therefore divided into 2 groups: AA <48° and AA ≥48°. AA in the 480 patients who underwent balloon-expandable (BE) TAVR did not influence acute procedural success or short-term clinical outcome. In contrast, increased AA among the 102 patients who underwent self-expandable (SE) TAVR was found to significantly attenuate procedural success (area under the curve: 0.73; 95% confidence interval: 0.61 to 0.85; p = 0.008). The numerical cutoff for AA with the highest sum of sensitivity and specificity for device success was ≥48° (sensitivity 85%, specificity 61%). Moreover, patients whose AA was ≥48° were also associated with an increased need for a second valve and post-dilation, had increased fluoroscopy time and increased valve embolization, and had increased post-procedural paravalvular regurgitation greater than or equal to mild following SE TAVR. Major complications at 30 days, including mortality were similar between AA groups. Six-month mortality was also similar between both AA groups. ConclusionsIncreased aortic root angulation adversely influences acute procedural success following SE but not BE TAVR. Because of these data, BE valves may be preferred when evaluating patients with high AA before TAVR.