Transcatheter Aortic Valve Replacement as a bridge to minimally invasive endoscopic mitral valve surgery in Elderly Patients in the era of ERAS and Fast Track TAVI concepts.

In this bicentric study, we report the outcomes of combined transcatheter aortic valve replacement combined with minimally invasive mitral valve surgery. We included a cohort of six patients (79.6 ± 3.2 years, 83% women) with high-risk profiles and deemed to be non-operable with combined mitral and aortic valvular disease. All patients had unsuitable anatomies for transcatheter mitral valve edge-to-edge repair (TEER). Moreover, most of the patients (5/6) suffered a combined aortic valve lesion, which complicates the efficiency of cardioplegia in the case of CBP through minimally invasive incisions. The first stage was implanting a TAVI valve to achieve aortic valve competency and hence facilitate the infusion of cardioplegia after clamping the aorta during endoscopic mitral valve surgery. After one week, we performed the minimally invasive mitral valve repair. Most patients (n = 5; 83%) underwent successful endoscopic mitral valve repair. Intraoperatively, the mean ischemic time was 42 min, and the total bypass time was 72 min. Postoperatively, the mean intubation time was 0 h. Postoperative complications included reoperation for bleeding in one patient (16.7%) and a new heart block requiring pacemaker implantation in one patient (16.7%). There was neither in-hospital mortality nor 1-year mortality.

Transcatheter Aortic Valve Implantation: Addressing the Subsequent Risk of Permanent Pacemaker Implantation.

Transcatheter aortic valve implantation (TAVI) is now a commonly used therapy in patients with severe aortic stenosis, even in those patients at low surgical risk. The indications for TAVI have broadened as the therapy has proven to be safe and effective. Most challenges associated with TAVI after its initial introduction have been impressively reduced; however, the possible need for post-TAVI permanent pacemaker implantation (PPI) secondary to conduction disturbances continues to be on the radar. Conduction abnormalities post-TAVI are always of concern given that the aortic valve lies in close proximity to critical components of the cardiac conduction system. This review will present a summary of noteworthy pre-and post-procedural conduction blocks, the best use of telemetry and ambulatory device monitoring to avoid unnecessary PPI or to recognize the need for late PPI due to delayed high-grade conduction blocks, predictors to identify those patients at greatest risk of requiring PPI, important CT measurements and considerations to optimize TAVI planning, and the utility of the MInimizing Depth According to the membranous Septum (MIDAS) technique and the cusp-overlap technique. It is stressed that careful membranous septal (MS) length measurement by MDCT during pre-TAVI planning is necessary to establish the optimal implantation depth before the procedure to reduce the risk of compression of the MS and consequent damage to the cardiac conduction system.

Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole.

OBJECTIVE: Ventricular secondary mitral regurgitation (SMR) (Carpentier type IIIb) results from left ventricular (LV) remodelling, displacement of papillary muscles and tethering of mitral leaflets. The most appropriate treatment approach remains controversial. We aimed to assess the safety and efficacy of standardised relocation of both papillary muscles (subannular repair) at 1-year follow-up (FU). METHODS: REFORM-MR (Reform-Mitral Regurgitation) is a prospective, multicentre registry that enrolled consecutive patients with ventricular SMR (Carpentier type IIIb) undergoing standardised subannular mitral valve (MV) repair in combination with annuloplasty at five sites in Germany. Here, we report survival, freedom from recurrence of MR >2+, freedom from major adverse cardiac and cerebrovascular events (MACCEs), including cardiovascular death, myocardial infarction, stroke, MV reintervention and echocardiographic parameters of residual leaflet tethering at 1-year FU. RESULTS: A total of 94 patients (69.1% male) with a mean age of 65.1±9.7 years met the inclusion criteria. Advanced LV dysfunction (mean left ventricular ejection fraction 36.4±10.5%) and severe LV dilatation (mean left ventricular end-diastolic diameter 61.0±9.3 mm) resulted in severe mitral leaflet tethering (mean tenting height 10.6±3.0 mm) and an elevated mean EURO Score II of 4.8±4.6 prior to surgery. Subannular repair was successfully performed in all patients, without operative mortality or complications. One-year survival was 95.5%. At 12 months, a durable reduction of mitral leaflet tethering resulted in a low rate (4.2%) of recurrent MR >2+. In addition to a significant improvement in New York Heart Association (NYHA) class (22.4% patients in NYHA III/IV vs 64.5% patients at baseline, p<0.001), freedom from MACCE was observed in 91.1% of patients. CONCLUSIONS: Our study demonstrates the safety and feasibility of standardised subannular repair to treat ventricular SMR (Carpentier type IIIb) in a multicentre setting. By addressing mitral leaflet tethering, papillary muscle relocation results in very satisfactory 1-year outcomes and has the potential to durably restore MV geometry; nevertheless, long-term FU is mandatory. TRIAL REGISTRATION NUMBER: NCT03470155.

Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry.

BACKGROUND: Functional mitral regurgitation (FMR) is one of the most common heart valve diseases that is a sequel of left ventricular remodelling. Although mitral valve annuloplasty is a standard treatment of FMR, the recurrence of FMR is a major drawback and occurs in 10-50% of patients. The REFORM-MR registry aims to investigate the effectiveness of standardized papillary muscle relocation and ring annuloplasty and to identify the risk factors associated with recurrent FMR. METHODS: REFORM-MR is a prospective, multicenter registry that enrols consecutive FMR patients across five sites in Germany. All patients with FMR and restricted movement of leaflets during systole (i.e., type IIIb mitral regurgitation) undergoing standardized subannular repair in combination with mitral valve annuloplasty are included in the study. The primary objective is to examine the effect of combined papillary muscle relocation and ring annuloplasty on the recurrence of FMR at 2 years postoperatively. The secondary objectives are MACCE rate, reinterventions on the mitral valve and cardiac-related mortality in the study cohort. Echocardiography core-lab and MRI core-lab will provide anonymized analysis of the imaging data in the REFORM-MR registry. Student's t-test or Mann-Whitney U test for continuous variables and the Chi-Square or Fisher exact test for categorical variables are used for group comparisons. Kaplan-Meier analyses is performed for survival and safety outcomes. RESULTS: As of May 2021, a total of 97 patients were enrolled across five sites in Germany. CONCLUSIONS: The results of this study will help define the outcomes of combined papillary muscle relocation and ring annuloplasty in the FMR treatment in a multicentre setting and to improve the understanding of the limitations of subannular repair procedures while treating patients with type III FMR. Trial registration clinicaltrials.gov Identifier: NCT03470155.

Transcatheter mitral valve implantation versus conventional redo surgery for degenerated mitral valve prostheses and rings in a multicenter registry.

OBJECTIVES: Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. METHODS: Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. RESULTS: Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P < .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P < .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group. CONCLUSIONS: In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

Transcatheter Aortic Valve Implantation with ACURATE neo: Results from the PROGRESS PVL Registry.

Objectives: The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE neo, a supra-annular self-expanding bioprosthetic aortic valve. Background: While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE neo valve has a pericardial sealing skirt designed to minimize PVL. Methods: The primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE neo. Results: The rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months (P < 0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient (P < 0.001) and effective orifice area (P=0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months. Conclusions: Results from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE neo valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.

Contemporary results of transcatheter mitral valve procedures: bi-centric retrospective analysis.

BACKGROUND: Transcatheter mitral valve-in-valve (TMVIV) or valve-in-ring (TMVIR) replacement offer an alternative therapy for high risk patients. We aimed to highlight the operative and postoperative results of TMVIV and TMVIR procedures. RESULTS: We included all patients underwent TMVIV and TMVIR procedures between 2017 and 2020 at two heart centers in Germany. We included a total of 36 high risk patients in our study where 12 received TMVIV and 24 received TMVIR. All patients underwent TMVIV or TMVIR with Edwards Sapien XT or S3 transcatheter valves (Edwards Lifesciences). The mean age was 79 (75-83 years old). The median (IQR) preoperative STS score was 9 (7-13)% and EuroSCORE II was 14.5% (12-16). The majority of our patients were operated via transapical approach (n = 26) and the minority via transseptal approach (n = 10). Out of our records, none of our patients required reopening for bleeding or any other surgical complications. None of our patients required reintervention during the 6 months follow-up period. One mortality was recorded on fifth postoperative day due to low cardiac output syndrome (obviously because of LVOT obstruction by the anterior mitral leaflet). The average blood loss was 200 ml in the first 24 h in patients underwent transapical approach. Average operative time was 93 min and all patients were immediately extubated after the procedure in the operating room (even the patient with echocardiographically documented LVOT obstruction who died on the fifth postoperative day). Length of Intensive Care Unit stay was 2 ± 1.2 days and length of hospital stay was 4.1 ± 1.2 days. In the follow up period, echocardiograms showed normal prosthetic valve function with low transvalvular gradients, no LVOT obstruction in TMVIR cases and no evidence of valve migration or thrombosis (except in one patient). Concerning 6 months readmission, it was recorded in 2 patients due to right sided heart failure symptoms due to preexisting high degree of tricuspid valve regurge which did not disappear or even decrease after the operation and the other patient due to gastrointestinal bleeding. CONCLUSIONS: TMVIV and TMVIR offer an efficient, safe and less invasive alternative in high surgical risk patients.

Extensive calcification of the mitral valve annulus in transcatheter aortic valve implants.

OBJECTIVES: This study sought to report the calcification pattern of the mitral valve annulus and its implications for procedural and safety outcomes in transcatheter aortic valve implantation. METHODS: Between November 2018 and September 2019, a total of 305 patients had transcatheter aortic valve implants at our institution. The extent of calcification of the mitral valve annulus was analysed, and the impact on safety outcomes was evaluated. RESULTS: The prevalence of mitral annular calcification (MAC) was 43%. Calcification of the mitral valve annulus was either less than or at least one-third of the posterior annulus (34% and 32%), the whole posterior annulus (28%) or the extension to the attachment of the anterior leaflets (7%). Severe circumferential MAC revealed moderate paravalvular leaks in 5/8 (63%) patients and was associated with right branch bundle block [odds ratio (OR) 2.01 (0.39-3.06); P = 0.098] and low cardiac output [OR 3.12 (1.39-7.04); P = 0.033]. Subannular calcification at the anterolateral trigonum represented a risk factor for left ventricular outflow tract injury [OR 3.54 (1.38-8.27); P = 0.001] in balloon-expandable valves, associated with relevant rhythm disorders [OR 2.26 (1.17-5.65); P = 0.014] and female gender (7/8, 88%). The 30-day all-cause mortality in circumferential MAC reaching into the anterior annulus (grade IV) compared to patients with less MAC (grade I-III) was 13% vs 2% with a mean valve size of 24.6 vs 25.7 mm. CONCLUSIONS: Extensive MAC was associated with moderate paravalvular leaks, with implications for the prosthesis size and survival in transcatheter aortic valve implants. In severe MAC, we recommend implanting oversized self-expandable prostheses, the goal being to reduce the risk of right branch bundle block and paravalvular leaks. SUBJ COLLECTION: 122, 125.

Cardiac tamponade following aortic root erosion by an Amplatzer PFO-Occluder in a 41-year-old woman: Only a matter of sizing?

A 41-year-old woman who had suffered an acute stroke underwent closure of a persistent patent foramen ovale (PFO) two months later. Eleven months after PFO closure the patient was hospitalized with signs of cardiogenic shock due to cardiac tamponade. Imaging studies showed a correct position of the left occluder disc, whereas the right atrial disc was in direct contact with the aortic root. At day 6, the patient underwent surgery via a minimally invasive route under cardiopulmonary bypass. The left atrial disc of the occluder was in a correct position. A too big right atrial disc together with a sharp angle misalignment toward the right atrial wall led to an erosion of the right atrial wall and of the wall of the aortic root. The occluder was explanted and the PFO closed by direct suture. Given the increasing number of procedures performed, serious and potentially life-threatening complications - even if rare - deserve special attention. Even though device oversizing was the most likely factor causing the erosion, other factors may play a role, as the patient used whole-body vibration starting three months before the incident. This could explain why the event happened as late as 11 months after the initial PFO closure. .

Thromboembolic complications in transfemoral aortic valve implantation due to aortic wall thrombus and shaggy aorta syndrome.

OBJECTIVES: Aortic wall thrombus (AWT) can affect suitability to endovascular repair, while its most aggressive entity is better known as shaggy aorta syndrome. Primary objective was to study the procedural and clinical outcome with regard to atherothrombotic AWT in transfemoral aortic valve implantation. METHODS: In a retrospective, single-centre analysis, a qualitative 0-10 AWT score classification system was used. The most severely affected aortic area in computed tomography angiography cross-section was assessed for the number of affected segments, thrombus type, thickness, area and circumference. Primary endpoints were 30-day mortality, neurologic, renal and pulmonary events and signs of solid organ infarction. RESULTS: Between November 2017 and September 2019, 604 patients underwent transfemoral transcatheter aortic valve implantation in our institution. Computed tomography-guided analysis revealed AWT in 11.3% and shaggy aorta syndrome in 6 patients (1.0% with 83.3% male). AWT was mainly present in the descending thoracic and abdominal aorta and was associated with acute renal failure (11.8% vs 3.2%, P ≤ 0.001) and a seven-fold increased rate of disabling peri-interventional stroke (4.4% vs 0.6%, P ≤ 0.001). In all patients with disabling peri-interventional stroke a balloon-expandable prosthesis was used (P ≤ 0.001). In case of shaggy aorta, mortality was more than six-fold increased (2.8% vs 16.7%, P = 0.046). CONCLUSIONS: Severe and irregular thrombus of the descending thoracic and abdominal aorta has been strongly associated with acute respiratory failure and peri-interventional stroke in transfemoral aortic valve implantation, being more likely using balloon-expandable devices. Our results imply important changes with regard to device design and present international transcatheter aortic valve implantation guidelines.

Double-Hit Mutations in Bicuspid Aortic Valve and Blunt Traumatic Acute Aortic Dissection.

We report on a young patient with a bicuspid aortic valve operated on for type A acute aortic dissection because of a blunt thoracic trauma. Aortic root replacement and ascending aortic and total arch repair together with the postoperative course were uneventful. Multigenerational genetic analyses revealed mutations in the NOTCH1 and ACTA2 genes in the patient and his father. The screening of his parents and children revealed no bicuspid aortic valve or aortic root dilation. This exceptionally rare case of double-hit mutations and the presence of blunt trauma reveals the complex etiology of aortic dissection in patients with a bicuspid aortic valve.

Comparison of microstructural alterations in the proximal aorta between aortic stenosis and regurgitation.

OBJECTIVE: We aimed to analyze the association among flow patterns, gene expression, and histologic alterations of the proximal aorta in patients with aortic valve disease. METHODS: A total of 131 patients referred for aortic valve replacement were grouped by valve dysfunction (aortic stenosis vs aortic regurgitation) and valve morphology (bicuspid vs tricuspid). On the basis of magnetic resonance imaging, aortic tissue from outer and inner curvature was collected for gene expression and histologic analysis. To identify differences in aortic remodeling, age- and sex-adjusted data for inflammation (CCL2, VCAM1, inflammation and atherosclerosis) and medial degeneration (COL1A1, ELN, fibrosis, elastin fragmentation, and cystic medial necrosis) were compared. RESULTS: First, we compared all patients with aortic regurgitation (n = 64) and patients with aortic stenosis (n = 67). In patients with aortic regurgitation, COL1A1 expression and all histologic markers were significantly increased. With respect to aortic diameter, all subsequent analyses were refined by considering only individuals with aortic diameter 40 mm or greater. Second, patients with bicuspid aortic valve were compared, resulting in a similar aortic diameter. Although patients with aortic regurgitation were younger, no differences were found in gene expression or histologic level. Third, valve morphology was compared in patients with aortic regurgitation. Although aortic diameter was similar, patients with regurgitant bicuspid aortic valve were younger than patients with regurgitant tricuspid aortic valve. Inflammatory markers were similar, whereas markers for medial degeneration were increased in patients with regurgitant tricuspid aortic valve. CONCLUSIONS: Our results indicate that the proximal aorta in patients with aortic regurgitation showed an increased inflammation and medial degeneration compared with patients with aortic stenosis. Refining both groups by valve morphology, in patients with bicuspid aortic valve, no difference except age was detected between aortic regurgitation and aortic stenosis. In patients with aortic regurgitation, tricuspid aortic valve revealed increased markers for medial degeneration but no differences regarding inflammatory markers.

Transcatheter Aortic Valve Replacement Without the Use of Contrast Medium: An Alternative Safe Implantation Technique.

BACKGROUND: New transcatheter equipment and accumulated experience have stimulated further refinements in implantation techniques. We aimed to compare the outcomes of transfemoral transcatheter aortic valve replacement (TF-TAVR) with and without the use of contrast medium (CM) in patients with glomerular filtration rate (GFR) <30 mL/min/1.73 m². METHODS: This single-center, retrospective study included all patients who underwent TF-TAVR procedure with Edwards Sapien balloon-expandable bioprostheses between September 2017 and September 2018 at the Zentralklinik Bad Berka Germany, and compared outcomes of TF-TAVR with and without the use of CM. RESULTS: A total of 98 consecutive patients were included in this study; 25 patients underwent TF-TAVR without the use of CM and 73 patients underwent TF-TAVR with the use of CM. Acute kidney injury was significantly higher in patients who received CM (15 patients [20.5%] in the control group vs 1 patient [4%] in the study group; P=.04). Other procedure-related complications were equally distributed between both groups. CONCLUSION: TF-TAVR without the use of CM can be considered a safe and reproducible alternative technique. Furthermore, it reduced the incidence of postoperative acute kidney injury in patients with GFR <30 mL/min/1.73 m².

Functional impairment assessed by the Barthel Index influenced outcomes after transcatheter aortic valve implantation.

Objective. We investigated the influence of functional impairment assessed by the Barthel index (BI) on the three-month outcomes after transfemoral-transcatheter aortic valve intervention (TF-TAVI) under general anesthesia. Design. We included retrospectively analyzed 336 patients undergoing TAVI between January 2017 and January 2018 in central hospital, Bad Berka, Germany. All patients were followed up at three-month in our center's outpatient clinic. We stratified the patients according to the BI. Results. At baseline, 76 patients had a BI <80. Patients with a BI <80 were characterized by advanced age (80.6 ± 5.6 vs. 83 ± 4.1 years. p = .027), diabetes mellitus on insulin and higher surgical risk scores. A prior cerebral ischemic event was recorded more in patients with a BI ≥80. Regarding intermediate outcomes, three-month mortality was significantly higher in patients with a BI <80. Patients with a BI <80 developed significantly more postoperative cardiac decompensation, delirium and strokes. Patients with BI <80 had lower hemoglobin level preoperative and needed more blood transfusion postoperative. Other valve academic research consortiums (VARCs) complications were equally distributed in both groups. A BI <80 was associated with prolonged postoperative hospital stay and was an independent predictor of FT protocol failure (OR 4; CI 95% 1.3-11. p .02). Conclusions. A BI <80 is associated with increased mortality and risk of neurological events and cardiac decompensations after TF TAVI. A BI <80 is an independent predictor of failure in fast track TAVI.

Implantation of Perceval in Trifecta ring: A new perspective.

We report a case of a 67-year-old woman who underwent an aortic valve replacement with a 23-mm Trifecta prosthesis (St. Jude Medical, St. Paul, MN, USA). We implanted Perceval S (LenoNova, London, UK) after resecting the degenerated leaflets three years later after the first operation. This strategy enabled us to reduce the ischemic time and hence simplify the surgical procedure in addition to providing excellent postoperative hemodynamics. .

Novel Association of a Familial TGFBR1 Mutation in Loeys-Dietz Syndrome with Concomitant Hematologic Malignancy.

Concomitant Loeys-Dietz syndrome (LDS) and hematologic malignancies are exceptionally rare. This is the first report of a patient operated on for aortic root dilation who had been previously diagnosed with LDS and B-cell-lymphoma. After completion of chemotherapy and complete remission, an elective valve-sparing aortic root replacement (using the David-V method) was performed. Due to the positive family history, pre-operative genetic counseling was conducted, and revealed LDS with a TGFBR1 (transforming growth factor beta receptor type I) mutation in 6 probands of the family, albeit in 1 of them posthumously. This missense mutation has been previously described in relation to aortic dissection, but a causative relationship to malignancy has so far neither been proposed nor proven.

Impact of Hierarchy on Multidisciplinary Heart-Team Recommendations in Patients with Isolated Multivessel Coronary Artery Disease.

Background: The Heart Team (HT) discussion has been incorporated in the current guidelines for myocardial revascularization in order to optimize treatment decisions for patients with multivessel coronary disease (MVD). There are no data in the literature, whether hierarchical issues do have an impact on HT decisions. We aimed to analyze the therapeutic recommendations of the multidisciplinary "Heart Team" (HT) for coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) if: (a) The head of cardiovascular surgery (HOS) and the head of cardiology (HOC) were present during the HT meeting, (b) both directors were absent, (c) only HOS or HOC was present. Methods: Retrospective analysis of all HT discussions between 2012 and 2015 in patients with isolated MVD (without any other cardiac problems requiring surgery). Results: During the study period, we analyzed 209 HT discussions in patients with isolated MVD. If neither HOS nor HOC was present at the HT discussion, the therapeutic recommendation was in 69% CABG and 31% PCI. If HOS and HOC were present in 77% CABG and 23% PCI was recommended (p = 0.34). If only HOS was present therapeutic recommendation was in 83% CABG and 17% PCI, and if only HOC was present the recommendation was in 54% CABG and 46% PCI (p < 0.0001). This difference did not attenuate during the study period. Conclusions: The hierarchy of the participating physicians significantly impacts treatment recommendations of a multidisciplinary HT in patients with isolated MVD. This impact did not attenuate after several years of Heart Team interaction.

Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expandable prosthesis.

AIMS: In the absence of randomised data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prosthesis using propensity matching. METHODS AND RESULTS: From 2012 to 2016, 1,306 patients at three German centres received either the ACURATE/ACURATE neo prosthesis (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighbour matching with exact allocation for access route and centre, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years old on average and had a logistic EuroSCORE I of 19%. Predilatation and post-dilatation were more frequent in the ACURATE group (97.6% versus 52.1%, p<0.001 for predilatation and 40.4% versus 11.6%, p<0.001 for post-dilatation), but rapid pacing for implantation was used less frequently (37.1% versus 98.2%, p<0.001). More-than-mild aortic regurgitation at postoperative echocardiography was 12.0% for the ACURATE group and 3.1% for the SAPIEN group, p≤0.001). More-than-mild aortic regurgitation in the ACURATE group differed amongst the centres with 6.0% (3/50) in centre A, 34.1% (29/85) in centre B and 3.4% (6/181) in centre C. Patients in the ACURATE group less frequently had pacemaker implantation compared to the SAPIEN 3 group (11.9% versus 18.5%, p=0.020), 30-day mortality was 4.6% versus 2.1%, respectively, p=0.134, and one-year survival was 83.1% (95% CI: 77.6-87.4) versus 88.8% (95% CI: 84.0-92.2). CONCLUSIONS: In this propensity score analysis, patients treated with the transapical ACURATE or transfemoral ACURATE neo prosthesis less frequently had pacemakers at 30 days but had more aortic regurgitation and lower one-year survival.

The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients.

OBJECTIVES: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. BACKGROUND: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far. METHODS: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. RESULTS: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. CONCLUSIONS: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.