Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

BACKGROUND: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. AIM: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. METHODS: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. RESULTS: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. CONCLUSIONS: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.

Incidence of Prosthesis-Patient Mismatch in Valve-in-Valve with a Supra-Annular Valve.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for a degenerated surgical bioprosthesis (valve-in-valve [ViV]) has become an established procedure. Elevated gradients and patient-prosthesis mismatch (PPM) have previously been reported in mixed TAVR cohorts. We analyzed our single-center experience using the third-generation self-expanding Medtronic Evolut R prosthesis, with an emphasis on the incidence and outcomes of PPM. METHODS: This is a retrospective analysis of prospectively collected data from our TAVR database. Intraprocedural and intrahospital outcomes are reported. RESULTS: Eighty-six patients underwent ViV-TAVR with the Evolut R prosthesis. Mean age was 75.5 ± 9.5 years, 64% were males. The mean log EuroScore was 21.6 ± 15.7%. The mean time between initial surgical valve implantation and ViV-TAVR was 8.8 ± 3.2 years. The mean true internal diameter of the implanted surgical valves was 20.9 ± 2.2 mm. Post-AVR, 60% had no PPM, 34% had moderate PPM, and 6% had severe PPM. After ViV-TAVR, 33% had no PPM, 29% had moderate, and 39% had severe PPM. After implantation, the mean transvalvular gradient was reduced significantly from 36.4 ± 15.2 to 15.5 ± 9.1 mm Hg (p < 0.001). No patient had more than mild aortic regurgitation after ViV-TAVR. No conversion to surgery was necessary. Estimated Kaplan-Meier survival at 1 year for all patients was 87.4%. One-year survival showed no significant difference according to post-ViV PPM groups (p = 0.356). CONCLUSION: ViV-TAVR using a supra-annular valve resulted in low procedural and in-hospital complication rates. However, moderate or severe PPM was common, with no influence on short-term survival. PPM may not be a suitable factor to predict survival after ViV-TAVR.

Propensity matched analysis of vascular complications using integrated or expandable sheaths for TAVR.

OBJECTIVES: Vascular access site complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). BACKGROUND: Medtronic's EnVeo PRO® low-profile sheath concept and Edwards' expandable eSheath® aim to lower vascular trauma and access site complications. This study aims to compare Valve Academic Research Consortium (VARC)-3 defined access-related vascular complications using the two different transcatheter heart valve (THV) delivery concepts. METHODS: We performed a retrospective, propensity-matched study to compare access site vascular complications in 756 consecutive patients who underwent a transfemoral TAVR using a Medtronic Evolut-R®/Evolut-PRO® or an Edwards Sapien3®/Sapien3ultra® THV. RESULTS: Propensity score matching resulted in 275 patient pairs. The primary endpoint of major VARC-3 vascular complication was 7.6% in the Medtronic group and 12.7% in the Edwards group (p = 0.066). Minor VARC-3 vascular complications were 9.1% and 8%, respectively (p = 0.76). VARC-3 bleeding complications (8.4% vs. 12.7%, p = 0.129) length of hospital stay (7.6 + 5.4 vs. 7.5 + 3.7 days, p = 0.783) and in-hospital mortality (1.1% vs. 0.4%, p = 0.624) were comparable between both groups. CONCLUSIONS: In a propensity-matched TAVR population, patients treated with the integrated sheath showed a trend towards fewer major vascular complications than patients treated with an expandable sheath, however, the difference was not statistically significant.

Stroke after transcatheter aortic valve replacement: A severe complication with low predictability.

OBJECTIVES: We aimed to describe stroke and transient ischemic attacks (TIAs) after transcatheter aortic valve replacement (TAVR) and to identify associated risk factors. BACKGROUND: Stroke/TIA after TAVR is a major complication. METHODS: A total of 1919 concomitant patients underwent TAVR in a single center from 2007 to 2017. Pre-, intra-, and postprocedural data were collected prospectively in a database and analyzed retrospectively. Stroke and TIA were documented according to the Valve Academic Research Consortium-II criteria. Logistic regression was used to determine risk factors for stroke after TAVR. RESULTS: Mean age was 79.5 ± 6.8 years, mean logistic EuroScore was 17.6% ± 12.8%, and 51.8% (n = 994) of the patients were female. Stroke/TIA occurred in 76 patients (3.9%), 1.9% were disabling, and 1.6% nondisabling. The predominant type of stroke were territorial ischemic lesions (82.4%), with primary bleeding in 4.4% and border zone infarctions in 4.4%. Left-sided lesions were more common (45.6% left sided vs. 25% right sided) and 13.2% of the lesions were bilateral (4.4% no finding and 11.8% missing data). In multivariate logistic regression, prior stroke (odds ratio [OR] = 1.83, p = 0.046) and initial experience (first 300 TAVR implanted at our center) were identified as independent risk factors for stroke/TIA during the first 30 days (OR = 1.95, p = 0.045). Overall, the occurrence of stroke had a highly significant impact on a 30-day mortality (13.2% vs. 4.9% in patients without stroke (p = 0.005). CONCLUSION: Stroke within the first 30 days after TAVR severely impairs 30-day survival. We identified prior stroke and initial experience as significant independent risk factors for the occurrence of stroke after TAVR.

Surgical explantation of failed transcatheter heart valves: indications and results.

Given the recent surge in transcatheter heart valve replacement (THVR), cardiac surgeons will surely face the challenge of eventual explantation. The aim of this study was to determine indications for reoperation, while exploring pertinent technical aspects and survival after THV explantation in a cohort originally deemed high risk or even inoperable. Between February 2008 and March 2019, 31 patients with failed transcatheter aortic valve replacement (TAVR) underwent surgical explantations at our facility. Data were prospectively collected for retrospective analysis of procedural indications, technical issues, and postoperative survival. The major reason for TAVR removal was bioprosthetic valve failure (BVF) due to infective endocarditis (IE: 16/31 [51.6%]), non-structural (NSVD: 14/31 [45.2%]) and structural (SVD: 1/31 [3.2%]) valve deterioration accounting for the rest. Mean age at THV explantation was 76.3 ± 8.3 years, and median time from TAVR to explantation was 153 days (0 days-56.6 months). Median ICU and hospital stay were 6 days (1-44 days) and 23 days (8-62 days), respectively. Thirty-day and 1-year survival rates were 74.2% and 67.2%, respectively. Median follow-up interval after explantation was 364 days (3 days-80 months). Mean cardiopulmonary bypass time was 124.6 ± 46.8 min, and mean aortic cross-clamp time was 84.3 ± 32.9 min. There was no need for unplanned aortic root repair owing to tissue damage during dissection of the TAVR from surrounding tissue. The most common reason for THV explantation was (a) BVF for IE and (b) BVF secondary to NSVD. Although 30-day and 1-year mortality rates in this multimorbid cohort were predictably high, no procedural mortalities occurred.

Surgical Cutdown Avoids Vascular Complications in Transcatheter Aortic Valve Replacement in Calcified and Small Femoral Arteries.

BACKGROUND: Third-generation transcatheter heart valves (THV) are predominantly implanted through a percutaneous, transfemoral access. To reduce vascular complications, we selectively performed surgical vascular access (cutdown) in patients with particular calcified or small femoral arteries. We aim to review our experience with this approach. METHODS: All patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with a third-generation THV at our institution between March 2014 and April 2019 were included in the study. All available computerized tomography studies were reassessed for access vessel diameter and visual graduation of calcifications. Vascular complications are reported according to Valve Academic Research Consortium-2 criteria. RESULTS: A total of 944 patients were included. Among them, 879 patients underwent a percutaneous access and 65 patients underwent surgical cutdown. Also, 459 Evolut R/PRO and 420 Sapien 3/ultra were implanted percutaneously and 40 Evolut R/PRO and 25 Sapien 3 were implanted with a surgical cutdown. Patients with surgical cutdown were older (80.0 ± 7.5 vs. 83.8 ± 7.5 years, p < 0.001), had smaller femoral arteries (8.0 ± 1.6 vs. 7.6 ± 1.6 mm, p = 0.034) and more severe vessel calcifications (17.5 vs. 1.0%, p < 0.001). Procedure time was similar for cutdown and percutaneous access (64.0 vs. 64.5 minutes, p = 0.879). With percutaneous access, 80 major vascular complications (10%) occurred, whereas with surgical cutdown, no major vascular complications occurred (p < 0.005). No wound infection occurred after surgical cutdown. The mean length of stay was 8 days in both groups. CONCLUSION: Surgical cutdown for vascular access avoids vascular complications in patients with small or severely calcified femoral arteries.

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

BACKGROUND: 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). METHODS: We retrospectively analyzed prospectively collected data from our designated TAVR database. Intraprocedural and intrahospital outcomes were reported. RESULTS: 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. CONCLUSION: 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.

Access site related vascular complications with third generation transcatheter heart valve systems.

OBJECTIVES: This study examines the impact of anatomical and procedural factors on Valve Academic Research Consortium-2-defined vascular complications at the femoral access site in transcatheter aortic valve replacement (TAVR) with third generation transcatheter heart valve (THV)-systems. BACKGROUND: Randomized clinical trials reported on vascular complications with current THV-systems. However, clinical presentation and consequences of these events are not well studied. METHODS: All patients who underwent a transfemoral TAVR using an Edwards Sapien3®/Sapien3ultra® or a Medtronic Evolut-R®/Evolut-PRO® have been identified from our institutional database. Only procedures utilizing the PerClose-ProGlide® vascular closure device were included. Risk factors for vascular complications were analyzed with a logistic regression model. Preoperative and procedural data were collected. The postoperative course of patients with and without vascular complications was compared. RESULTS: A total of 878 patients met the inclusion criteria. Of these, 152 patients (17.3%) had an access-site related vascular complication (87 major complications, 9.9%). Sheath-to-femoral-artery-ratio (SFAR) (OR per 0.1 increase = 1.35, p < .001) and more than 2 vessel entries with large bore sheaths (OR = 1.76, p = .029) were independent risk factors for vascular complications. Female gender (OR = 1.44, p = .07) and two vessel entries with large bore sheaths (OR = 1.2, p = .53) increased the risk, although no statistical significance was shown. Age (OR = 1.07, p = .62), body mass index (OR = 1.1 per 5 points, p = .32) and vessel wall calcification at puncture site (OR = 0.93, p = .7) had no influence on vascular complications. Patients with vascular complications had a higher need for blood transfusion (p < .001) and a higher in-hospital mortality (2.6 vs. 0.4%, p = .019). CONCLUSIONS: Procedural risk assessment should include SFAR calculation and consider the need for large bore sheath exchange. This might reduce the vascular trauma, lower vascular complication rates and improve the clinical outcome after TAVR.

Effects of a dual-filter-based cerebral embolic protection device in transcatheter aortic valve replacement on cerebral oxygen saturation: A prospective pilot study.

PURPOSE: The Sentinel Cerebral Protection System (Sentinel-CPS) is increasingly used in transcatheter aortic valve replacement (TAVR). However, the impact of inserting the Sentinel-CPS inside the brain-supplying arteries on cerebral perfusion and oxygenation is unknown. METHODS: Twenty patients undergoing transfemoral TAVR with (n = 10) and without (n = 10) cerebral embolic protection using the Sentinel-CPS were prospectively observed. All patients received conscious sedation and cerebral oxygen saturation (rSO2 ) was continuously measured with near-infrared spectroscopy (NIRS). The cumulative perioperative cerebral desaturation was calculated for each patient by multiplying rSO2 below an individualized desaturation threshold by time. In addition, rSO2 values at the time of Sentinel-CPS insertion, filter positioning, and device retraction were analyzed. RESULTS: There was no significant difference in cumulative cerebral desaturation in patients with Sentinel-CPS (median [IQR]) (0 [0/81] s%) and without (median [IQR]) (0 [0/23] s%), p = .762. A total of 6 patients (33.3%) experienced a perioperative decrease in rSO2 below the individualized desaturation threshold (n = 3 with Sentinel-CPS, n = 3 without Sentinel-CPS; p = 1.000). Cerebral desaturation was detected during valve deployment (n = 5) and after postdilatation (n = 1). No desaturation events occurred during Sentinel-CPS insertion, filter positioning, or retraction. CONCLUSION: Our pilot study revealed no difference in cumulative perioperative cerebral desaturation between TAVR with and without Sentinel-CPS. Catheter- and filter-based manipulations in the brain-supplying arteries for Sentinel-CPS application were not associated with a decrease of cerebral perfusion and oxygenation.

Anatomical reasons for failure of dual-filter cerebral embolic protection application in TAVR: A CT-based analysis.

BACKGROUND: The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment. AIM OF THE STUDY: We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application. METHODS: Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application. RESULTS: The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92-324] vs. 150 [42-252], p = .046), a higher brachiocephalic tortuosity index (27 [5-51] vs. 10 [0-102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22-80] vs. 39° [7-104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups. CONCLUSIONS: Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°.

Successful treatment of a paravalvular leak with balloon cracking and valve-in-valve TAVR.

Transcatheter heart valve implantation into degenerated bioprosthetic valves (ViV-THV implantation) has become an established procedure for high risk patients. In general, paravalvular leak (PVL) is a contraindication for valve-in-valve-TAVR (ViV-TAVR). Herein, we report on a 81-year-old patient presenting with acute heart failure for a failing aortic bioprosthesis (Medtronic Mosaic 27 mm). Intraoperative transesophageal echocardiography during urgent ViV-TAVR revealed a PVL previously not detected. After transfemoral implantation of a 26 mm-Evolut-R, balloon-fracturing of the bioprosthetic ring was performed using a 24 mm True Dilatation balloon for treatment of the PVL. Afterward, left ventricular to aortic peak-to-peak pressure gradient measured 2-4mmHg. Transesophageal echocardiography merely revealed trace PVL. Aortic root angiography showed no PVL. At discharge, echocardiography measured a transprosthetic mean gradient of 5mmHg detecting no PVL. Intentional ring-fracturing of an aortic valve prostheses may prove not only to be effective in lowering transvalvular gradients after valve-in-valve-TAVR, but may also be a tool to treat PVL alongside degenerated surgical aortic bioprostheses in certain patients.

Percutaneous nitinol-based vascular closure device for large bore arterial access hemostasis: Results of a prospective multicenter study.

BACKGROUND: Vascular complications during transcatheter aortic valve replacement (TAVR) still pose a significant concern regarding procedural safety. Designated closure devices for large-bore vascular access are needed. METHODS: Patients undergoing TAVR were prospectively enrolled into the study. The InSeal vascular closure device (VCD) achieves hemostasis by utilizing a crescent-shaped nitinol scaffold covered by a biodegradable membrane, which is delivered at the arterial puncture site. The coprimary endpoints were predefined as hemostasis within 15 min following vessel access site closure and after activated clotting time falls below 200 s and the rate of related major vascular adverse events in first month. RESULTS: A total of 50 patients were prospectively enrolled into the study, with an average age of 80.8 ± 7.4 years and 62% males. Hemostasis with the Inseal VCD was achieved in 94% of the patients with average time-to-hemostasis of 51 ± 97 s. The rates of in-hospital vascular complications were 12% mostly driven by minor vascular complications (10%). Femoral artery stents were used in three patients due to failed hemostasis. CONCLUSIONS: Initial clinical experience indicates that a novel, nitinol-based, large-bore vascular closure device is safe and effective in achieving hemostasis after TAVR.

TAVR in Patients on Hemodialysis: Outcome of A High-Risk Patient Group.

BACKGROUND: Perioperative mortality is high and long-term survival is poor for patients on hemodialysis undergoing surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) offers a safe and effective therapy for high-risk patients suffering from aortic valve stenosis. However, in patients on hemodialysis only limited information is available on the outcome following TAVR. METHODS: Of the 2613 consecutive patients in our single-center TAVR registry, all hemodialysis patients, were identified. Demographics, procedural details, clinical outcomes, mortality, and complications were evaluated. RESULTS: Forty-two hemodialysis patients with a mean age of 75.2±8.2 years, a mean STS predicted risk of mortality of 11.1±9.5% and a mean logEuroScore of 27.9±18.8% underwent TAVR. Mean duration on hemodialysis prior to intervention was 62.8±49.6 months. A transfemoral access was chosen in 24 patients, a transapical in 16, and a transaxillary and a transaortic in one patient, respectively. Estimated survival at 30 days, one, three and five years was 83.3%, 68.3%, 37.7% and 18.9%, respectively. Estimated median survival was 1.8±0.4 years. VARC-2 defined perioperative complications included stroke in 7.1% (3/42), major bleeding in 16.7% (7/42), and vascular complications in 7.1% (3/42). In two patients, echocardiographic examination at three and four years, respectively, showed evidence for structural valve deterioration. CONCLUSION: A high number of patients with ESRD undergoing TAVR require a non-transfemoral access. Predominantly, bleeding events contribute to the perioperative morbidity. An estimated median survival of less than two years after TAVR allows only limited assessment of valve prosthesis durability. Cardiovascular and non-cardiovascular mortality contribute equally to the causes of death beyond the first year after TAVR.

Early outcomes of transapical mitral valve implantation versus surgical replacement in matched elderly patients at intermediate surgical risk.

BACKGROUND: Data comparing transcatheter mitral valve implantation (TMVI) with surgical mitral valve replacement (SMVR) are lacking. AIMS: This study sought to compare the 30-day Valve Academic Research Consortium (VARC)-3 device success of TMVI with that of SMVR. METHODS: Matching protocol combined exact matching (sex, atrial fibrillation, previous surgical aortic valve replacement [SAVR] or coronary artery bypass grafting [CABG]), coarsened exact matching (age) and propensity score matching (body mass index, mitral valve pathology and concomitant tricuspid regurgitation). RESULTS: A total of 40 Tendyne TMVI and 80 SMVR patients with similar baseline characteristics were analysed (TMVI vs SMVR): age (78 years [interquartile range [{IQR} 75; 80] vs 78 years [IQR 73; 80]; p=0.8), female (60% vs 60%; p=1.0), atrial fibrillation (67.5% vs 63.7%; p=0.8), previous SAVR (12.5% vs 10.0%; p=0.8), previous CABG (20.0% vs 16.2%; p=0.8), body mass index (25.54 kg/m² vs 25.24 kg/m²; p=0.7) and valve pathology (mitral regurgitation: 70.0% vs 73.8%, mitral stenosis: 7.5% vs 3.8%, and mixed disease: 22.5% vs 22.5%; p=0.6). Most baseline characteristics not included in the matching model were balanced among the TMVI/SMVR cohorts: European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (5.8% [IQR 2.9; 7.5] vs 4.2% [IQR 2.4; 6.8]; p=0.3) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score (5.2% [IQR 3.2; 8.6] vs 4.1% [IQR 3.3; 6.1]; p=0.076). Coronary artery disease (67.5% vs 32.5%; p<0.001) and previous percutaneous coronary intervention (47.5% vs 25.0%; p=0.023) differed among groups. Mitral VARC (MVARC) device success at 30 days was achieved in 82.5% of patients after TMVI and 57.5% of patients after SMVR (p=0.04). MVARC procedural success at 30 days was 75.0% after TMVI versus 52.5% after SMVR (p=0.07). Thirty-day mortality (2.5% vs 3.8%; p=0.47), technical success (97.5% vs 97.5%; p=1.0), major bleeding (17.5% vs 18.7%; p=0.087), stroke (5.0% vs 4.9%; p=1.0) and postoperative haemodialysis (7.5% vs 5.2%; p=0.4) were similar in both groups. CONCLUSIONS: Patients with intermediate surgical risk, according to STS-PROM and EuroSCORE II, demonstrated higher rates of MVARC device at 30 days after TMVI compared to 30 days after SMVR. Rates of survival and procedural success, neurological, renal and bleeding complications were similar. Transfusion count and length of stay were lower after TMVI. For elderly patients at intermediate risk, a TMVI eligibility assessment may be considered.

Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry.

BACKGROUND: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. OBJECTIVES: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. METHODS: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. RESULTS: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. CONCLUSIONS: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335).

Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli.

Background: Clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is currently in the focus of clinical research. Patients with small aortic annulus are at higher risk to display PPM. Data on incidence and clinical consequences of PPM after TAVR with either balloon-expandable (BEV) or self-expanding (SEV) transcatheter heart valves in small aortic annulus are sparse. Methods: Patients with small aortic annulus (perimeter < 72 mm or aortic annulus area < 400 mm2) who underwent BEV or SEV with contemporary transcatheter heart valve types were identified from the institutional TAVR database. Propensity score matching was applied for imbalanced baseline characteristics between patients undergoing BEV or SEV. Echocardiography and clinical follow-up beyond 3 years was reported following VARC-3 recommendations. Primary endpoint was the incidence of pre-discharge PPM and its association with 3-year mortality. Results: From a total of 507 patients with small aortic annulus, 192 matched patient pairs with SEV or BEV were identified. Mean age was 81 ± 7 (SEV) vs. 81 ± 6 (BEV) years (p = 0.5), aortic annulus perimeter was 69 ± 3 vs.69 ± 3 mm, (p = 0.8), annulus area was 357 ± 27 vs.357 ± 27 mm2 (p = 0.8), and EuroScore II was 5.8 ± 6.6 vs.5.7 ± 7.2 (p = 0.9). SEV resulted in less moderate (20% vs. 31%, p < 0.001) and severe pre-discharge PPM (9% vs.18%, p < 0.001) compared to BEV. At discharge (7 ± 4 vs. 12 ± 9 mmHg, p = 0.003) and at 1-year follow-up (7 ± 5 vs.13 ± 3 mmHg, p < 0.001), SEV displayed lower mean gradients compared to BEV. Estimated survival after SEV was 85% (95% confidence interval (CI): 80%-90%) at 1 year, 80% (95% CI: 75%-86%) at 2 years, and 71% (95% CI: 65%-78%) at 3 years; estimated survival after BEV was 87% (95% CI: 82%-92%) at 1 year, 81% (95% CI: 75%-86%) at 2 years, and 72% (95% CI: 66%-79%) at 3 years, with no significant difference among the groups (p = 0.9) Body surface area (OR: 1.35, p < 0.001), implantation of BEV (odds ratio (OR): 3.32, p < 0.001), and the absence of postdilatation (OR: 2.16, p < 0.001) were independent risk factors for any PPM. At 3 years, patients without PPM had a higher 3-year survival compared with patients with ≥moderate PPM (77% vs. 67%, p = 0.03). Conclusion: BEV implantation in patients with small annulus was associated with a twofold higher incidence of pre-discharge severe PPM compared to SEV implantation. Survival at 3 years after TAVR was similar after BEV and SEV. However, patients with the absence of pre-discharge PPM had a higher 3-year survival compared to patients with ≥moderate PPM.

Results of new-generation balloon vs. self-expandable transcatheter heart valves for bicuspid aortic valve stenosis.

Background: Data comparing new-generation self-expandable (SEV, Evolut R/PRO) vs. balloon-expandable (BEV, SAPIEN 3/3Ultra) transcatheter heart valve replacement (TAVR) in bicuspid aortic valve stenosis (BAV) is limited. Our aim was to compare 30-day results of SEV and BEV implantations in patients with BAV. Methods: A total of 2009 patients underwent TAVR between April 2015 and June 2021 at our Centre. From our institutional registry, we identified 106 consecutive patients with BAV who underwent TAVR using SEV and BEV. Results: A 106 patients (n = 68 BEV; n = 38 SEV) were included. Mean age was 74.6 ± 8.8 years (BEV) vs.75.3 ± 8.7 years (SEV) (p = 0.670) and Society of Thoracic Surgeons score was 2.6 ± 1.9 (BEV) vs. 2.6 ± 1.6 (SEV) (p = 0.374), respectively. Device landing zone calcium volume (DLZ-CV) was 1168 ± 811 vs. 945 ± 850 mm3 (p = 0.192). Valve Academic Research Consortium (VARC)-3 device success at 30 days was similar (BEV 80.9% vs. SEV 86.8%; p = 0.433). More post-dilatations were performed in SEVs (23.5% BEV vs. 52.6% SEV; p = 0.002). Overall mean gradient at 30 days follow-up was 11.9 ± 4.6 mmHG (BEV) vs. 9.2 ± 3.0 mmHG (SEV) (p = 0.002). A mild-moderate degree of paravalvular leak (PVL) was detected more often in the SEV group (7.4% vs. 13.2%; p = 0.305). A trend towards higher rate of permanent pacemaker implantation was observed in SEV (11.8% vs. 23.7%; p = 0.109). Conclusions: Treatment of BAV revealed similar performance using BEV and SEV. In this retrospective cohort study, hemodynamics were more favorable with the SEV, although there was a trend toward more PVL and significantly more post-dilations.

Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology.

BACKGROUND: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. METHODS: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. RESULTS: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07). CONCLUSIONS: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology.

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR). AIMS: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry. METHODS: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality. RESULTS: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality. CONCLUSIONS: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.