Valve Academic Research Consortium Criteria Research Articles

Transcatheter Aortic Valve Replacement for a Degenerated Transcatheter Valve-A Single Center Experience.

The transcatheter valve-in-valve treatment (TAV-in-TAV) of degenerated transcatheter aortic valves is becoming more relevant, as the use of transcatheter aortic valve replacement (TAVR) increases. We report our experience with TAV-in-TAV in patients with a degenerated transcatheter heart valve (THV). We retrospectively analyzed prospectively collected data from our designated TAVR database. Intraprocedural and intrahospital outcomes were reported. Ten patients out of a total of 3,144 TAVR implantations since 2007 presented with a degenerated THV, among those six with an Edwards Sapien XT (Edwards Lifesciences, Irvine, California, United States) valve, treated with a Medtronic Evolut R (Medtronic, Dublin, Ireland) valve. Four patients had severe stenosis, one pure insufficiency, and five combined stenosis and insufficiency. Average time between initial implantation and re-intervention was 6.8 ± 1.3 years. The mean preoperative maximum and mean gradients were 54.2 ± 14.8 mm Hg and 31.6 ± 9.9 mm Hg, respectively. Nine patients underwent transfemoral and one patient underwent transaortic TAV-in-TAV. Mean procedural time was 86.2 ± 51.5 minutes. Post-implantation, the maximum and mean gradients decreased to 18 ± 6.9 mm Hg and 8.4 ± 3.2 mm Hg (16 ± 8 mm Hg and 6.4 ± 1.7 mm Hg in the Evolut-in-Sapien subgroup), respectively. The valve area increased from 0.98 ± 0.28 mm Hg to 1.72 ± 0.32 mm Hg (0.8 ± 0.07 mm Hg to 1.9 ± 0.16 mm Hg in the Evolut-in-Sapien subgroup). Two patients experienced a vascular complication. No further Valve Academic Research Consortium-2 criteria complications occurred during hospitalization. TAV-in-TAV resulted in low procedural and peri-procedural complication rates. In particular, the usage of a supra-annular valve resulted in excellent hemodynamic results. Larger studies are required to validate this observational data and to establish a protocol for this procedure.

Transcatheter valve-in-valve implantation versus surgical redo aortic root replacement in patients with degenerated freestyle aortic bioprosthesis.

Transcatheter aortic valve-in-valve implantation (ViV TAVI) represents a new treatment option for patients with degenerated aortic bioprosthesis. Comparative data to redo surgical aortic valve replacement (redo SAVR) are limited. We investigated feasibility and outcome of ViV TAVI versus redo SAVR in patients with symptomatic degenerated Medtronic Freestyle aortic bioprosthesis (FSB). Between January 2002 and February 2020, 25 patients with failed FSB underwent ViV TAVI and 10 patients with failed FSB underwent redo SAVR. Endpoints were defined according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Age and logistic EuroSCORE II were higher in patients with ViV TAVI (75.4± 1.7 vs. 62.9± 5.1 years, p= .019; 11.5± 1.6 vs. 5.6± 5.6%, p= .007). Valve implantation was successful in all cases. Mean transvalvular pressure gradients were significantly lower in patients with redo SAVR than ViV TAVI (7.6± 1.0 vs. 10.3± 0.8 mmHg, p= .037). Aortic valve regurgitation was absent in 91% and 100% of patients with ViV TAVI and redo SAVR, respectively. Thirty-day mortality rates were 12% in the ViV TAVI cohort versus 0% in the redo SAVR cohort (p= .542). Within the first year after hospital discharge, one patient after ViV TAVI had redo surgical intervention. ViV TAVI and redo SAVR lead to excellent functional results in patients with degenerated FSB. Post-procedural early complications must be considered particularly in patients with ViV TAVI because of higher clinical risk profiles.

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes.

The NeoChord echo-guided transapical beating heart repair is a promising early-stage minimally invasive surgical procedure for degenerative mitral valve (MV) regurgitation (DMR) correction. The technique has been improved since its inception following procedure standardization, patient selection optimization, and learning curve stabilization. We hereby present the mid-term clinical results through three years of our large single center experience. All consecutive patients with severe symptomatic DMR due to prolapse or flail of one or both mitral leaflets that underwent the NeoChord procedure between November 2013 and June 2019 were included. Patients were categorized according to MV anatomy; Type A isolated central posterior leaflet prolapse and/or flail, Type B posterior multi-segment prolapse and/or flail, Type C anterior and/or bi-leaflet prolapse or flail, Type D paracommissural prolapse and/or flail and/or significant leaflet and/or annular calcifications. Patients underwent clinical and echocardiographic follow-up at one, three, six, twelve months and yearly thereafter. Clinical outcomes and the composite primary endpoint (patient success) were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria. Mitral regurgitation (MR) severity was graded as absent, mild, moderate and severe according to American Society of Echocardiography (ASE) and European Society of Cardiology (ESC) guidelines. Two hundred and three patients were included; median follow-up was 24 months [interquartile range (IQR), 9-36]. Median age was 64 years (IQR, 54-74 years), median Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) was 0.60% (IQR, 0.32-1.44%). There were 106 Type A patients (52.2%), 68 Type B (33.5%), 16 Type C (7.9%), and 13 Type D (6.4%). Kaplan-Meier estimate of survival was 99.0%±0.7% at one and two years and 94.0%±2.9% at three years. At one-year follow-up patient success was 91.2%±2.0% and 111 patients (74%) presented a residual MR mild or less (1+). At three-year follow-up patient success was 81.2%±3.8% and 32 patients (64%) had a residual MR mild or less (1+). Patient success was significantly different according to anatomical type (P=0.001). Echocardiographic analysis showed a significant acute left ventricle and left atrial reverse remodeling that was maintained up to three years. The NeoChord echo-guided transapical beating heart repair procedure demonstrated good clinical outcomes and echocardiographic results up to three-year follow-up.

Abstract 16322: Safety and Efficacy of Transapical Transcatheter Aortic Valve Replacement in the Treatment of Pure Non-calcified Native Aortic Regurgitation

Background: Transcatheter aortic valve replacement (TAVR) in patients with pure aortic regurgitation (AR) is still “off-label” use due to the lack of suitable transcatheter heart valve. This study aimed to evaluate the safety and efficacy of TAVR with J-Valve TM (JieCheng Medical Technology Co., Ltd., Suzhou, China) transcatheter heart valve for the treatment of patients with pure non-calcified native AR. Methods: The clinical and follow-up data of patients with pure non-calcified native AR treated by TAVR with J-Valve TM between April 2014 and November 2019 in the West China Hospital were summarized. Procedural results and clinical outcomes were analyzed using Valve Academic Research Consortium-2 criteria. Results: A total of 123 patients were enrolled with a mean age of 72.1±6.4 years. There were 28 cases with bicuspid aortic valve and 95 cases with trilobal aortic valve. The median follow-up period was 18 months. Transapical implantation with J-Valve TM was successful in all patients (100%). By the end of the follow up, the rate of all-cause mortality was 5.7%, among which 5 cases died during the perioperative period. Other results include stroke (1.6%), new permanent pacemaker implantation (8.9%), major bleeding (6.5%), acute kidney injury (2.4%) and aortic valve-related re-intervention (3.3%, they were given surgical aortic valve replacement for thrombosis of artificial valve (2 cases) or severe post-procedural paravalvular leakage (2 cases)). Among the 112 survival cases without re-intervention, Echocardiography revealed that none of them had moderate or severe paravalvular leakage; mild and mild-moderate paravalvular leakage occurred in 9.8% and 8.0% cases, respectively. Mean transvalvular gradient after valve implantation was 9.2±3.5 mmHg. At 6 months of follow up, left ventricular end diastolic diameter was remarkably smaller compared to that before procedure (53.5±8.2 mm vs 64.3±8.9 mm, P<0.001) and left ventricular ejection fraction was significantly increased (56.3±11.8 % vs 54.2±12.4 %, P=0.031). Conclusions: TAVR with J-Valve TM transcatheter heart valve system for treatment of patients with pure non-calcified native AR is safe and effective which may be a reasonable option in the future treatment.

Unique technical challenges in patients undergoing TAVR for failed aortic homografts.

Surgical reoperation for aortic homograft structural valve degeneration (SVD) is a high-risk procedure. Transcatheter aortic valve replacement (TAVR) for homograft-SVD is an alternative to reoperation, but descriptions of implantation techniques are limited. This study compares outcome in patients undergoing into two groups by the type of previously implanted aortic valve prosthesis: TAVR for failed aortic homografts (TAVR-H) or for stented aortic bioprostheses (TAVR-BP). From 2015 to 2017, TAVR was performed in 41 patients with SVD. Thirty-three patients in the TAVR-BP group (six for SVD of valved conduits), and eight patients in the TAVR-H group. The Valve Academic Research Consortium criteria were used for outcome reporting purposes. The patients with TAVR-BP had predominant prosthetic stenosis (94%, p = .002), whereas TAVR-H individuals presented mostly with regurgitation (88%, p = <.001). Patients with TAVR-H received: Sapien-3 (6), Sapien-XT (1), and CoreValve (1) devices. Low, 40% ventricular fixation in relation to homograft annulus was attempted to anchor the prosthesis on the homograft suture-line. One patient with TAVR-BP experienced intraoperative distal prosthesis migration and Type-B aortic dissection, and two patients in the TAVR-H group had late postoperative proximal device migration. In both groups, there was zero 30-day mortality, stroke, or pacemaker implantation. TAVR for failing aortic homografts may be a feasible and safe alternative to high-risk surgical reintervention. Precise, 40%-ventricular device positioning appears crucial for prevention of late paravalvular leak/late prosthesis migration and minimizing the risk of repeat surgical intervention.

Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial

The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis. The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000,137-40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR. The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.

The effect of underweight on mid-term outcome following transcatheter aortic valve implantation: an insight from multicenter registry

Abstract Background Obesity has the adverse prognostic impact in the general population, whereas paradoxical effect of obesity has been reported in patients with heart failure. Several studies have suggested the same obesity paradox in patients undergoing transcatheter aortic valve implantation (TAVI), however, they included limited number of underweight patients. Purpose The aim of this study was to clarify the effect of underweight on outcome following TAVI. Methods We retrospectively analyzed consecutive 1,027 patients undergoing TAVI between April 2010 and June 2019. The patients were categorized according to body mass index (BMI) as follows: underweight (&amp;lt;18.5 kg/m2, n=150), normal weight (18.5 to 25 kg/m2, n=657), and overweight (&amp;gt;25 kg/m2, n=220). BMI was defined as body weight (kg) divided by the square of body height (m) measured at the hospital admission. We compared the short- and mid-term outcome after TAVI among three groups, and all clinical events were accordance with Valve Academic Research Consortium-2 criteria. Results Underweight patients were more often female, and had a higher prevalence of hypertension, dyslipidemia, peripheral artery disease, anemia, and hypoalbuminemia. They also presented lower ejection fraction, smaller aortic valve area, and higher surgical risk score. In procedural findings, device unsuccess and major vascular complication more occurred in underweight patients, but 30-day mortality was equivalent among three groups. The mid-term survival of the underweight was inferior to the other two groups (figure).In the multivariate analysis, female (hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.37–0.73, P=0.0002), atrial fibrillation (HR 2.22, 95% CI 1.56–3.17, P&amp;lt;0.0001), albumin value (HR 0.37 per 1-g/dl increase, 95% CI 0.25–0.55, P&amp;lt;0.0001), Society of Thoracic Surgeons score (HR 1.06 per 1% increase, 95% CI 1.02–1.06, P=0.0039), 30-day combined endpoint (HR 2.12, 95% CI 1.33–3.38, P=0.0017), and underweight (HR 1.59, 95% CI 1.04–2.37, P=0.026) were associated with the survival after TAVI. Conclusion The underweight had a worse mid-term prognosis, representing the obesity paradox in the TAVI population. Kaplan-Meier curves Funding Acknowledgement Type of funding source: None

Transapical approach versus transcervical approach for transcatheter aortic valve replacement: a retrospective monocentric study.

Transfemoral approach is the standard access-route for transcatheter aortic valve replacement (TAVR). However, alternative approaches are needed in a number of patients and accesses such as transapical (TA) TAVR or transcervical (TC) are used. We aimed to compare clinical and echocardiographic outcomes after TA-TAVR or TC-TAVR. All patients who underwent TA- and TC-TAVR for severe aortic stenosis in our institution between 2008 and 2020 were retrospectively included. End points included 30-day all-cause mortality, procedural complications (according to the Valve Academic Research Consortium-2 criteria), procedure duration, intensive care unit (ICU) length of stay (LOS) and overall hospital LOS. For 30-day all-cause mortality, we furthermore used a Cox proportional-hazards model to adjust for significant between-group differences in baseline characteristics as well as difference in year of intervention. TAVR was performed in 176 patients, using a TA approach (n = 127) or a TC approach (n = 49). Baseline clinical and echocardiographic characteristics were comparable between the 2 groups, except age and peripheral artery disease. All-cause 30-day mortality rates were not significantly different (8.5% in the TA group vs 2.3% in the TC group, P = 0.124). TC approach was associated with significantly shorter procedure duration {71.0 [interquartile range (IQR) 52.5-101.0] vs 93 [IQR 80.0-120.0] min, P < 0.001}, shorter ICU LOS [0.0 (IQR 0.0-0.0) vs 1.0 (IQR 1.0-3.0) days, P < 0.001] and shorter hospital LOS [7.0 (IQR 5.0-9.5) vs 14.0 (IQR 10.0-22.0) days, P < 0.001]. The TC approach may be a good first-choice alternative in case of contraindications to transfemoral-TAVR.

Contemporary Transcatheter Mitral Valve Replacement for Mitral Annular Calcification or Ring.

The aim of this study was to evaluate outcomes of commercial transcatheter mitral valve replacement (TMVR) for annular rings and calcification using contemporary techniques. TMVR is evolving in the absence of other viable treatment options for severe mitral annular calcification and failing ring repairs. The concomitant use of laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction and pre-emptive alcohol septal ablation is not well studied in clinical practice. A single-center study was conducted of valve-in-mitral annular calcification (ViMAC) and valve-in-ring (ViRing) TMVR from September 2015 to April 2020. In-hospital and 30-day outcomes were assessed. Forty patients underwent TMVR (28 ViMAC and 12 ViRing). Sixteen ViMAC (57%) and 5 ViRing (42%) patients underwent attempted laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction. Three patients underwent pre-emptive alcohol septal ablation. The median index hospitalization was 7days. Six patients died within 30days of the procedure, 6 (21%) in the ViMAC group and none in the ViRing group. Five patients (13%) had left ventricular outflow tract obstruction: 4 (14%) in the ViMAC cohort and 1 (8%) in the ViRing cohort. Five patients (13%) had either intraprocedural valve embolization or late migration (4 ViMAC and 1 ViRing). Technical success defined according to Mitral Valve Academic Research Consortium criteria was present in 25 patients (63%): 9 (75%) in the ViRing cohort and 16 (57%) in the ViMAC cohort. At 30days, the mitral valve gradient was significantly reduced (5.5 ± 2.1 vs. 10.6 ± 4.8; p<0.01). Three patients (8%) had at least moderate residual mitral regurgitation. Transcatheter ViMAC and ViRing can be successfully performed but frequently require the use of contemporary adjunctive techniques.

Transcatheter Aortic Valve Implantation With J-Valve: 2-Year Outcomes From a Multicenter Study

We report the 2-year follow-up outcomes of the J-Valve in the treatment of either aortic stenosis (AS) or pure aortic insufficiency (AI) from a multicenter study. From March 2014 to October 2016, 107 patients with either AS (n= 63) or pure AI (n= 44) were enrolled in a trial and were treated by transcatheter aortic valve implantation with the J-Valve system. All patients except 1 completed a 2-year clinical and echocardiographic follow-up (follow-up rate of 99%). The procedural and clinical outcomes were presented according to Valve Academic Research Consortium-2 criteria. The success rate of the device was 91.5%. All-cause mortality was 4.7% and 10.3% at 30 days and 2 years, respectively. Echocardiographic follow-up showed mild prosthetic valve regurgitation in 1.0% and 6.8% of patients at 30 days and 2 years, respectively. No patient showed more than mild aortic prosthetic regurgitation. At the 2-year follow-up, 97.6% of patients had mild or less than mild paravalvular leak and 99.8% of patients experienced notable improvement in heart failure symptoms (at least 1 NYHA level reduction). We found no major differences in echocardiographic and clinical follow-up between AS and AI, except for a significantly higher transvalvular gradient in the AS cohort (P= .01). This study demonstrated good midterm outcomes of transcatheter aortic valve implantation with the J-Valve system in the treatment of patients with either AS or AI. It suggests that the J-Valve system is a promising alternative therapy in high-risk patients.

Double transcatheter balloon-expandable valve implantation for severe valve dysfunction in high-risk patients: initial experience.

Concomitant valvular heart valve disease is a frequent finding, with higher morbidity and mortality among patients undergoing redo surgical procedures. Our goal was to report our initial experience with combined transcatheter Inovare bioprosthesis implants for severe valve dysfunction. Among 300transcatheter procedures, a total of 6 patients had concurrent simultaneous transcatheter bioprosthesis implants for severe mitral bioprosthesis failure (valve-in-valve), with a second valve procedure that included native aortic (n = 2) or degenerated bioprostheses in the aortic position (n = 4). During the procedures, all patients were treated with a balloon-expandable Inovare transcatheter valve, using the transapical approach. Patients were highly symptomatic [New York Heart Association (NYHA) functional class IV: 100%], with a mean age of 62 ± 5 years, yielding a mean European System for Cardiac Operative Risk II (EuroSCORE II) of 24.0 ± 10.1%. There was a mean of 1.6 ± 0.4 prior valve operations/patient, with a median time from prior mitral bioprosthesis surgery of 13.0 (9.2-20.0) years. Device success was 100% according to the Mitral Valve Academic Research Consortium and the Valve Academic Research Consortium-2 criteria. During the hospital stay, only 1 patient required dialysis, and the median intensive care unit and hospital lengths of stay were 5.0 (3.2-6.7) days and 16.0 (12.2-21.2) days, respectively. No deaths occurred at 30 days; at a median follow-up of 287 (194-437) days, 1 patient died of a non-cardiac cause and the rest of patients were in NYHA functional class I or II, with normofunctioning bioprostheses. Transcatheter double valve interventions using the Inovare bioprosthesis in this initial series were shown to be a reasonable alternative to redo surgical operations. The short- and mid-term clinical and echocardiographic outcomes demonstrate promising results, although future studies with a larger number of patients and longer follow-up are warranted.

One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve

Bioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients. To assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement. In this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data. Mitral valve-in-valve for degenerated bioprosthetic mitral valves. The primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance. A total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg. Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal.

Background The prevalence of peripheral vascular disease has led to the re-emergence of percutaneous axillary vascular access as a suitable alternative access site to femoral artery. We sought to investigate the efficacy and safety of manual hemostasis in the axillary artery. Methods Data were collected from a prospective internal registry of patients who had a Maquet® (Rastatt, Germany) Mega 50 cc intra-aortic balloon pumps (IABP) placed in the axillary artery position. They were anticoagulated with weight-based intravenous heparin to maintain an activated partial thromboplastin time (aPTT) of 50–80 seconds. Anticoagulation was discontinued 2 hours prior to the device explantation. Manual compression was used to achieve the hemostasis of the axillary artery. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. Results 29 of 46 patients (63%) achieved axillary artery homeostasis via manual compression. The median duration of IABP implantation was 12 days (range 1–54 days). Median compression time was 20 minutes (range 5–60 minutes). There were no major vascular or bleeding complications as defined by the VARC-2 and BARC-2 criteria, respectively. Conclusion Manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Large prospective randomized control trials may be needed to corroborate these findings.

Late Adverse Cardiorenal Events of Catheter Procedure-Related Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Data regarding the longitudinal effect of catheter procedure-related acute kidney injury (AKI) on clinical outcomes are limited. This study aimed to assess the late adverse cardiorenal events of AKI following transcatheter aortic valve implantation (TAVI). A total of 2,518 patients who underwent TAVI, excluding in-hospital deaths, were enrolled from the Japanese multicenter registry. The definition of AKI was determined using the Valve Academic Research Consortium-2 criteria. The incidence, predictors, major adverse renal and cardiac events (MARCE), and all-cause mortality of AKI were evaluated. MARCE included readmission for renal and heart failure (HF), hemodialysis requirement, and cardiovascular-renal death during the follow-up period. The incidence of AKI was 9.7% in the entire cohort. The significant predictive factors of AKI were men, diabetes mellitus, hypertension, chronic kidney disease, low albumin, overdose of contrast media, nontransfemoral approach, transfusion, vascular complications, and new pacemaker implantation. The rates of HF readmission and future hemodialysis were significantly higher in patients with AKI than in those without AKI (19.7% vs 9.0%, p <0.001, 3.3% vs 0.4%, p <0.001, respectively). Cox regression multivariate analysis showed that AKI occurrence was an independent predictive factor for the incremental risk of both MARCE and late mortality up to 4 years (hazard ratio [HR] 1.59, 95% confidence interval [CI] 0.75 to 1.20, p <0.001, HR 2.18, 95% CI 1.70 to 2.79; p <0.001, respectively). In conclusion, AKI occurrence was significantly associated with late adverse cardiorenal events after TAVI. Adequate clinical management can be expected to reduce AKI-related late phase cardiorenal damage even after successful TAVI.

Comparison of Frequency of Vascular Complications With Ultrasound-Guided Versus Fluroscopic Roadmap-Guided Femoral Arterial Access in Patients Who Underwent Transcatheter Aortic Valve Implantation

To compare outcomes of ultrasound guidance (USG) versus fluoroscopy roadmap guidance (FG) angiography for femoral artery access in patients who underwent transfemoral (TF) transcatheter aortic valve implantation (TAVI) to determine whether routine USG use was associated with fewer vascular complications. Vascular complications are the most frequent procedural adverse events associated with TAVI. USG may provide a decreased rate of access site complications during vascular access compared with FG. Patients who underwent TF TAVI between July 2012 and July 2017 were reviewed and outcomes were compared. Vascular complications were categorized by Valve Academic Research Consortium-2 criteria and analyzed by a multivariable logistic regression adjusting for potential confounding risk factors including age, gender, body mass index, peripheral vascular disease, Society of Thoracic Surgeons score and sheath to femoral artery ratio. Of the 612 TAVI patients treated, 380 (63.1%) were performed using USG for access. Routine use of USG began in March 2015 and increased over time. Vascular complications occurred in 63 (10.3%) patients and decreased from 20% to 3.9% during the study period. There were fewer vascular complications with USG versus FG (7.9% vs 14.2%, p = 0.014). After adjusting for potential confounding risk factors that included newer valve systems, smaller sheath sizes and lower risk patients, there was still a 49% reduction in vascular complications with USG (odds ratio 0.51, 95% confidence interval 0.29 to 0.88, p = 0.02). In conclusion, USG for TF TAVI was associated with reduced vascular access site complications compared with FG access even after accounting for potential confounding risk factors and should be considered for routine use for TF TAVI.

Outcomes of Transcatheter Aortic Valve Replacement in Transplant Recipients

ABSTRACT Background Transcatheter aortic valve replacement (TAVR) has become the mainstay in the treatment of patients with severe calcific aortic stenosis. However, little is known about the outcomes of TAVR in transplant recipients. Methods Patients who underwent TAVR and transplant were compared to a control group of TAVR patients who did not have a transplant, between 2014 and 2017. The primary endpoints were all-cause mortality and the onset of prosthetic valve endocarditis. The secondary endpoints were based on the Valve Academic Research Consortium-2 (VARC-2) criteria. Propensity score matching, based on age, race, and gender, was used to compare the outcomes between transplant and non-transplant patients. Results 35 patients underwent TAVR as well as organ transplants (26 solid organ and 9 bone marrow). Compared to non-transplant patients (n = 1,366), transplant patients underwent TAVR at a younger age. After matching, transplant patients (n = 34) were more likely to develop prosthetic valve endocarditis compared to non-transplant patients (n = 68) (p = 0.04); however, the majority were on immunosuppressive agents. Transplant patients had a higher 3-year mortality rate, but not 30-day and 1-year mortality (p < 0.001). NYHA after TAVR was also higher in transplant patients (p = 0.04). There was no significant difference in other outcomes based on VARC-2 criteria. Conclusion Transplant patients undergo TAVR at a younger age, yet are at an increased risk of post-TAVR complications. In transplant patients, survival is similar to non-transplant patients at 30 days and 1-year. TAVR is a viable treatment option for patients with organ transplantation and severe symptomatic aortic stenosis. Abbreviations AR: Aortic Regurgitation; AS: Aortic Stenosis; AVR: Aortic Valve Replacement; CHF: congestive heart failure; IQR: Interquartile Ranges; NYHA: New York Heart Association; PVR: Paravalvular Regurgitation; TAVR: Transcatheter Aortic Valve Replacement; VARC: Valve Academic Research Consortium

Feasibility and safety of a fully percutaneous transcatheter aortic valve replacement program.

This study aimed to assess the feasibility and safety of conducting an entire transcatheter aortic valve replacement (TAVR) program by using percutaneous techniques only. Surgically assisted transthoracic TAVR has been reported to be associated with more complications and longer hospital stays. During 2019, all TAVR at a single center were performed by standard transfemoral (TF), intravascular lithotripsy-assisted TF, transaxillary (TAx), or transcaval approach using percutaneous techniques only. No patients were denied TAVR because of access. Procedural and clinical endpoints were categorized using Valve Academic Research Consortium-2 criteria. In total, 306 consecutive TAVR patients were enrolled (mean age 78.9 ± 7.2 years). Most patients were treated by TF approach (94.8%)-of these, nine (2.9%) were pre-treated with intravascular lithotripsy. A percutaneous TAx and transcaval approach were used in 12 (3.9%) and four patients (1.3%), respectively. There were no procedural deaths and one peri-procedural stroke. Valve performance was satisfying in 298 patients (97.4%); six patients had a moderate aortic regurgitation and two patients had a mean gradient ≥20 mmHg following valve-in-valve procedure. The 30-day major vascular complication and major bleeding rate was 2.3% and 3.9%, respectively. A new permanent pacemaker was implanted in 41 patients (13.4%). Of all patients, 81% were discharged within two days post-TAVR, including 11 out of 12 TAx patients and all transcaval cases. A fully percutaneous TAVR program is feasible and safe with favorable immediate and early clinical outcomes and allowing a short hospital stay.

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System

The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system. Transseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair. Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria. Fourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8mmHg (median). New York Heart Association functional class improved to≤II in 9 patients (81.8%). This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.

Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score Matched Analysis

The CoreValve Evolut R and PRO (Medtronic, Minneapolis, MN, USA) are among the newest-generation of self-expandable transcatheter aortic valve replacement (TAVR) devices and show excellent results. Treating patients with severely calcified (SC) native aortic valve anatomy may be challenging because of the increased risk of periprocedural complications. This study investigated the performance of Evolut R and PRO in this special patient subset. Patients who underwent TAVR with the CoreValve Evolut R or PRO (n=381) from September 2015 to March 2018 were divided by aortic valve calcification extent. Patients with SC aortic valve anatomy (n=98; men, >2,062 and women, >1,377 Agatston units) were compared with those with non-severely calcified (NCS) aortic valve anatomy after 1:2 propensity score matching. Outcomes were evaluated according to the updated valve academic research consortium criteria. Patients with SC anatomy were older (83 years vs 80 years, p<0.001) and had a smaller aortic valve area (0.63 cm2 vs 0.70 cm2, p=0.028). Pre-dilatation was more often performed (30.6% vs 15.8%, p=0.003) and a permanent pacemaker implantation was more often necessary (32.9% vs 8.8%, p<0.001) in the SC group. None/mild aortic regurgitation (AR) was evenly distributed (SC, 96.9% vs NCS, 99.5%, p=0.109); moderate AR was present in 3.1% of SC patients and in 0.5% of NSC patients. Severe AR was not observed. The CoreValve Evolut R and PRO showed good clinical safety profiles and excellent haemodynamic results in patients with SC anatomy and who more often required permanent pacemaker implantation.

Early Outcome in Patients Requiring Conversion to General Anesthesia During Transfemoral Transcatheter Aortic Valve Implantation

Transfemoral Transcatheter Aortic Valve Implantation (tf-TAVI) has become an established therapy-option for patients with symptomatic severe aortic stenosis. Conscious sedation (CS) has proven to be an alternative to general anesthesia . So far, the outcome of patients undergoing unplanned periprocedural conversion from CS to general anesthesia has not been investigated. All patients undergoing transfemoral transcatheter aortic valve implantation in CS between 2014 and 2019 were included. The primary end point was early safety at 30 days according to Valve Academic Research Consortium-2 criteria. The reasons for conversion and length of ICU-/ hospital stay were further analyzed. Of 1,058 included patients 35 (3.3%) required a conversion. The end point was documented in 13 (37%) of the converted and 110 (11%) of nonconverted patients (p < 0.001). The causes were: unrest in 11/35 patients, procedural complications in 10/35 patients, respiratory distress in 8/35, and cardiovascular decompensation in 6 patients (17.1%). Compared with the group without conversion (Median (interquartile range ), 4 [4-5] days), length of hospital stay was longest in the group with procedural complications (6 [1-11] days) followed by cardiovascular decompensation (5 [4-7] days). In conclusion, the conversion rate to general anesthesia was low in a large cohort of unselected transcatheter aortic valve implantation patients. Additionally, hospital stay was longer dependent on the reason for conversion.