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Background Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). Objectives The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. Methods Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. Results A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). Conclusions In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

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 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.

Transcatheter aortic valve replacement is an established treatment for high- or intermediate-risk patients with symptomatic aortic valve stenosis. As more low-risk patients are being treated, transcatheter heart valve durability is gaining importance. Data on structural valve deterioration beyond 8 years after transcatheter aortic valve replacement is limited.To evaluate the outcomes of transcatheter aortic valve replacement in high-risk patients with a follow-up of ≥10 years, focusing on survival and structural valve deterioration, according to the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery definitions.Only patients with a follow-up of ≥ 10 years were included in this study (n=510). Using serial echocardiographic data, the cumulative incidences of structural valve deterioration and bioprosthetic valve failure were analysed. Receiver operating characteristic analysis was used for predictor assessment.Mean age was 79.6±6.7 years, with a mean logistic EuroSCORE of 19.8±12.7%. Immediate procedural mortality was 2.9%, and 30-day mortality was 7.8%. Kaplan-Meier-estimated survival at 10 years was 10.3±1.5%. At 10 years, the cumulative incidences of severe and moderate structural valve deterioration were 4.3% and 13%, respectively, for the total population. The cumulative incidence of bioprosthetic valve failure at 10 years was 9.0%. There was a significant difference in the rates of structural valve deterioration and bioprosthetic valve failure depending on valve type: structural valve deterioration, SAPIEN 8.9% vs CoreValve 2.2% at 10 years (P=0.001); bioprosthetic valve failure, SAPIEN 13.9% vs CoreValve 6.7% at 10 years (P=0.021).Structural valve deterioration and bioprosthetic valve failure of early transcatheter heart valves was low at 10 years. The identified differences between valve types must be validated using current-generation devices in younger patients.

Vascular access site complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR).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.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.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.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.

Background A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve. Methods and results This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe). Conclusions TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.

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°.

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.

Background There is a growing use of cerebral protection devices in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed to analyze if the use of these devices itself has an impact on the complexity and the risk of TAVR. Methods Between February 2016 and July 2017, 391 patients underwent transfemoral TAVR with Medtronic CoreValve Evolut R (n = 196) or Edwards Sapien 3 (n = 195). In 39 patients, the Claret Sentinel™ embolic protection device (CS-EPD) was used. Prospectively collected data were retrospectively analyzed, comparing fluoroscopy/operation time, amount of contrast used, vascular events, and postprocedural renal function in TAVR patients with (n = 39) and without (n = 352) CS-EPD. Results The CS-EPD was placed through the right radial (n = 35) or brachial (n = 4) artery. Procedural success rate defined as correct deployment and retraction of both filters was 94.9%. No device-related vascular complications occurred. TAVR patients with CS-EPD showed a significantly higher total operation time, total fluoroscopy time, and amount of used contrast (85.4 ± 39.3 vs. 64 ± 29.8 minutes, p = 0.002; 20.7 ± 9.3 vs. 13.7 ± 7 minutes, p ≤ 0.001; 133.7 ± 42.6 vs. 109.7 ± 44.5 mL, p = 0.001). Comparing the initial third of patients receiving a CS-EPD with the last third of CS-EPD cases, procedural time had decreased significantly (102.5 ± 34.9 vs. 67 ± 11.9; p = 0.002). There were no differences in postprocedural renal failure (p = 0.80). Conclusion Our data add evidence that the application of the CS-EPD is not associated with an additional risk for the patient. Although procedural time and amount of contrast are still higher when using the CS-EPD, there were no device-related complications or increased incidence of renal failure.

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 Conclusion Surgical cutdown for vascular access avoids vascular complications in patients with small or severely calcified femoral arteries.

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.

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.

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.

Aims Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. Methods and results A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2–12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02–1.13)], age [HR 1.21 (95% CI 1.01–1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11–1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis–patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31–14.39)], device malposition [SHR 3.75 (95% CI 1.36–10.35)], EBEV [SHR 3.34 (95% CI 1.26–8.85)], and age [SHR 0.59 (95% CI 0.44–0.78)]. Conclusions The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.

Aims We sought to determine the long-term outcome of high-risk patients who underwent transcatheter aortic valve replacement (TAVR) with first-generation devices with a focus on the identification of predictors for mortality and valve durability. Methods and results Consecutive patients in our prospective single-centre registry undergoing TAVR with first-generation devices (n=214 CoreValve; n=86 SAPIEN) between 06/2007 and 07/2009 were retrospectively analysed (n=300, mean age 81.43±6.55 years, mean STS score 6.5±4.5%). Kaplan-Meier estimates of survival and the Cox proportional hazards model were used to identify independent predictors of all-cause-mortality. At 1, 5, and 7 years, estimated survival rates were 76.0%, 40.2%, and 23.2%, respectively. Age-adjusted baseline predictors of mortality included atrial fibrillation, impaired kidney function, peripheral artery disease, and mitral regurgitation (≥moderate). Baseline risk-adjusted procedure-related predictors for all-cause mortality included acute kidney injury, neurological events, major vascular complications, and major/life-threatening bleeding. At both five and six years, 78.2% of surviving patients were in NYHA Class I or II. PVL was ≤mild in the majority of patients at discharge and throughout follow-up. At seven years, the overall crude cumulative incidence of structural valve deterioration according to the 2017 EAPCI/ESC/EACTS definition was 14.9% (CoreValve 11.8% vs. SAPIEN 22.6%; p=0.01). Conclusions Seven years after TAVR, 23.2% of high-risk patients were still alive. Independent predictors of all-cause mortality included both patient- and procedure-related factors. With a cumulative incidence of 14.9% at seven years, there is some suggestion that SVD post TAVR may become increasingly relevant during longer-term follow-up.

Objectives Simultaneous surgical off-pump coronary revascularization and transcatheter aortic valve implantation (TAVI) as a hybrid procedure may be a therapeutic option for patients with a TAVI indication who are not suitable for percutaneous coronary intervention and for patients who have an indication for combined surgical aortic valve implantation and coronary artery bypass grafting but present with a porcelain aorta. Early outcomes of these patients are analysed in this study. Methods From February 2011 to April 2017, hybrid TAVI/off-pump coronary artery bypass (OPCAB) was performed in 12 (60%) patients, hybrid TAVI/minimally invasive direct coronary artery bypass in 6 (30%) patients and staged TAVI/OPCAB in 2 (10%) patients. Endpoints of this study were 30-day mortality, device success and postoperative adverse events as defined by the updated Valve Academic Research Consortium (VARC-2). Results The median age at the time of surgery was 77 years [interquartile range (IQR), 70-81] with a median logistic EuroSCORE and Society of Thoracic Surgeons' Predicted Risk score of 16.1% (IQR, 9.3-28.1) and 3.9% (IQR, 2.2-5.6), respectively. The median Synergy between PCI with Taxus and Cardiac Surgery score was 16.5 (IQR, 9.8-22.8). TAVI implantation routes were transaortic in 9 (45%) patients, transapical and transfemoral in 5 (25%) patients each and trans-subclavian in 1 (5%) patient. Complete myocardial revascularization was achieved in 75% of patients. Device success rate was 100%. Paravalvular aortic regurgitation did not exceed mild in any patient. Stroke/transient ischaemic attack, vascular complications and myocardial infarction were not observed. Re-exploration for bleeding was required in 1 (5%) patient. Thirty-day mortality was 0%. Conclusions Hybrid OPCAB/MIDCAB and TAVI prove to be a safe and effective alternative treatment option in selected higher risk patients.

Transkatheter-Aortenklappenimplantationen (TAVI) nehmen jahrlich deutlich zu, verbunden mit einem Wandel der Patientenselektion zu jungeren und gesunderen Patienten. Darstellung der aktuellen Herausforderungen und Zukunftsperspektiven von TAVI. Umfassende Literatursuche, Vorstellung aktueller Studien und Diskussion von Schwerpunktthemen. In den letzten 8 Jahren hat sich die Zahl an durchgefuhrten TAVI in Deutschland verzwanzigfacht. Die Effektivitat bei Hochrisikopatienten wurde wissenschaftlich nachgewiesen, und erste Studien zu Patienten mit einem mittleren Risiko zeigen ebenfalls gute Ergebnisse. Schwerwiegende Komplikationen sind sehr selten geworden. Dank der Entwicklung neuer Klappendesigns und Implantationstechniken konnen Komplikationen wie vaskulare Verletzungen, Schlaganfall oder paravalvulare Lecks deutlich reduziert werden. Die Schrittmacherimplantationsrate ist aktuell noch hoher als bei beim chirurgischen Aortenklappenersatz. Neuere Untersuchungen haben auf das Thema Klappenthrombose aufmerksam gemacht, das noch ausfuhrlicherer Untersuchung bedarf. Die rasche Weiterentwicklung und der Zugewinn an Erfahrung lassen eine Ausdehnung der Indikationsstellungen zu. Die TAVI hat sich als sichere und effektive Behandlungsoption fur Hochrisikopatienten entwickelt. Die zunehmende Erfahrung und Verbesserung der Technologien erlauben eine kontinuierliche Abnahme der periprozeduralen Komplikationen. Vor dem Einsatz bei Patienten mit einem niedrigen operativen Risiko bedarf es allerdings noch weiterfuhrender Studien.

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

Background Aortic valve repair (AV-repair) is an alternative treatment option for patients with aortic regurgitation (AR), but durability is still reason for concern, especially for bicuspid aortic valves (BAV). We retrospectively evaluated mid-term results after AV-repair in patients with BAV or tricuspid aortic valves (TAV), including reoperation rates, recurrence of regurgitation, and survival. Methods Patients undergoing AV-repair between November 2004 and March 2016 without procedures involving the aortic root were included. Echocardiographic examinations were performed before and after the operation and at follow-up. Repair techniques were recorded and evaluated. Results Of 150 patients, 89 (59.3%) had TAV and 61 (40.7%) BAV. AR ≥ moderate was found in 66 patients with TAV (74.2%) and 49 with BAV (80.3%). At discharge, 74 TAV-patients had ≤ mild AR (84.4%), 11 (12.4%) moderate. 57 patients (93.4%) with BAV had ≤ mild AR, 1 (1.6%) moderate and 2 (3.3%) severe. Mean follow-up was 4.4±2.7 years with ≤ mild AR in 56 TAV patients (73.7%) and moderate in 18 (20.2%). In patients with BAV, 43 (76.8%) had ≤ mild AR and 4 (6.6%) moderate. Survival in patients with TAV was significantly decreased compared to BAV (P=0.033), but reoperation-rates did not differ significantly (P=0.651). Conclusions AV-repair is a safe and feasible option in patients with AR and can achieve similar results in patients with TAV and BAV. The complexity of the repair technique predicts repair failure.

Background/Purpose With the growing use of transcatheter aortic valve replacement (TAVR), we need to determine if repeat TAVR (TAV-in-TAV) is comparable or even superior to surgical aortic valve replacement followed by TAVR (TAV-in-SAV). Although TAV-in-SAV procedures were shown to provide an almost complete sealing of paravalvular leakage at the expense of elevated gradients, data for TAV-in-TAV are lacking. Hence, we compared echocardiographic and clinical outcome in all TAV-in-TAV and TAV-in-SAV procedures in our institution between Oct. 2007 and July 2017. Methods 130 consecutive valve-in-valve patients out of 2351 TAVR-patients were identified. 24 patients were excluded. Patient data were analysed from our prospectively collected, institutional database. 93% underwent routine out-patient follow-up at 12 months. Results 75 TAV-in-SAV (75±8 years, male 60%; STS score 5.2±4.0%) and 31 TAV-in-TAV patients (78±8 years, male 65%; STS score 4.6±2.8%) formed the final study population. The type of TAV was similarly distributed in both groups (self-/balloon-expandable valves [%] 57/43 vs. 61/39) with transfemoral being the most frequent access site (68% vs. 87%). The mode of prosthesis failure was mainly stenosis in the TAV-in-SAV group (77%), whereas it was mainly intraoperative paravalvular regurgitation (90%) in the TAV-in-TAV group. 10% TAV-in-TAV patients (78±10 years, 33% male, STS score 5.1±1.5%) underwent redo-TAVR for prosthesis-degeneration after a mean time of 2614±862 days. The TAV-in-TAV group (90% single session vs. 10% staged: mean gradient 10±4 mmHg vs. 15±3 mmHg, p=0.096; aortic valve area 1.62±0.36 cm2 vs. 1.45±0.18 cm2, p=0.240) showed lower gradients and larger aortic valve areas (Table 1). No major intraprocedural complications occurred in either group. 30-day mortality was 0%. Table 1 75 TAV-in-SAV discharge 31 TAV-in-TAV discharge p-value 69 TAV-in-SAV 12mFU 30 TAV-in-TAV 12mFU p-value AVA (cm2) * 1.18±0.32 1.61±0.35 Conclusion Indications for TAV-in-TAV differ from those for TAV-in-SAV. TAV-in-TAV results in significantly lower gradients and larger aortic valve areas with no relevant aortic regurgitation. Accordingly, failed TAV valves may be treated with TAV-in-TAV in the future.

AIMS The Valve Academic Research Consortium (VARC) endpoint definitions were established to standardise the reporting of clinical outcomes following transcatheter aortic valve implantation (TAVI). It remains unclear, however, to what extent and in which manner these definitions are applied. Therefore, we sought to investigate the utilisation and adherence to VARC guidelines since their introduction in 2011 across peerreviewed TAVI-related publications. METHODS AND RESULTS We performed a systematic literature review to identify TAVI-related manuscripts published between February 2011 and February 2014. Manuscripts were categorised into three groups: a "compliant" group of manuscripts using only VARC-defined endpoints, a "non-compliant" group of manu scripts with only non-VARC-defined endpoints, and a "mixed compliant" group of manuscripts with both VARC- and non-VARC-defined endpoints. Multivariate analyses were performed to identify predictors of VARC use. Among 5,023 published manuscripts, 498 were included in the final analysis. At least one VARC definition was used in 275 (54%), while 223 (43%) did not use any VARC definitions. After publication of the first VARC manuscript (VARC-1, January 2011), VARC use increased from 31% (n=15) at six months to 69% (n=84) at 36 months. Following the publication of VARC-2 (October 2012), VARC-1 use declined (from 58% [n=47] to 36% [n=24]), while VARC-2 use increased from 4% (n=3) at six months to 35% (n=23) at 18 months. Of the manuscripts using VARC, 49 (10%) were classified as compliant and 226 (46%) as mixed compliant. The following endpoints were more often defined using VARC vs. non-VARC: myocardial infarction (64% vs. 36%); stroke (56% vs. 44%); bleeding (79% vs. 21%); vascular complications (70% vs. 30%); acute kidney injury (63% vs. 37%); reintervention (67% vs. 33%); and composite endpoints (52% vs. 48%). Mortality, valve dysfunction, TAVI-related complications, and quality of life were more often defined using non-VARC criteria. CONCLUSIONS Implementation of VARC criteria in peer-reviewed manuscripts has increased over time. There remain, however, a considerable number (43%) of publications that do not report outcomes according to VARC. These data will inform the future development of VARC criteria.

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.

Patients with multivalvular disease (MVD) are common and often present with heterogeneous valve defects. Evaluation is complicated by interactions among various valve pathologies. Trials and guidelines focus primarily on single-valve disease, providing few recommendations for the treatment of patients with MVD. This article provides an insight into percutaneous treatment possibilities for this heterogeneous patient population.

Objectives During the last decade, various plate fixation systems have been developed for the treatment of complicated sternal dehiscence after open-heart surgery. One of them is the Modular Sternal Cable System© (MSCS), which promises optimal distribution of forces along the whole sternum by using plates, cannulated screws and cables. However, in comparison with other systems, there is a lack of outcome data. Methods Sternal reconstruction with the MSCS was performed in 11 patients (male n = 10, age 72.0 ± 7.3 years) with complicated sternal dehiscence following cardiac surgery, and 73% of them had a history of sternal infection. Sternal reconstruction included bilateral longitudinal plating and thoracic re-closure with 4-9 cables. Patients received postoperative examination, focusing on sternal wound conditions and clinical stability. If there was any suspicion of recurrent wound infection, computed tomographic scans were done in the early postoperative period or in the long term, in order to evaluate bony consolidation and integrity of osteosynthetic material. Results The mean operation time was 165 ± 59 min, the mean intubation time 4.7 ± 5.3 min and the mean intensive care unit length of stay was 1 day (median) (range 1-23 days), with a total hospital stay of 9 days (median) (range 5-64 days). Operative mortality was 0%. One patient died on the 65th postoperative day of a non-MSCS-related cause. Sternal wound infection occurred in 6 patients (54.5%) and made hardware removal necessary in 5 of them early postoperatively (median 14 days) and in 1 patient late postoperatively (1058 days). In another patient, material was removed 715 days after MSCS application due to persisting sternal pain. Conclusions A high incidence of postoperative wound infections was observed after implantation of the MSCS. It may be speculated that hardware design (e.g. the absence of a locking system, large screws) compromises osseous microcirculation, favouring the development of infection. This should be kept in mind for further development of sternal reconstruction systems.

ObjectiveWe aimed to analyse the incidence of prosthesis–patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event.MethodsA total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls).ResultsModerate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta −0.023; 95% CI −0.032 to –0.014; PConclusionsSevere PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.

Minimally invasive mitral valve repair with placement of artificial chordae for mitral valve regurgitation has become the standard of care. In some cases, such as Barlow's disease or bileaflet prolapse, papillary muscle exposure may be difficult. By using a valve sizer to retract both leaflets, visualization can be optimized, thus simplifying suture placement and thereby minimizing cross-clamp and cardiopulmonary bypass times. This technique is simple, is cost effective, and can be applied quickly.

Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an increase of patients presenting with failing bioprosthetic surgical valves in need of a reoperation is to be expected. Redo surgery may pose a high-risk procedure. Transcatheter aortic valve-in-valve implantation is an innovative, less-invasive treatment alternative for these patients. However, a comprehensive evaluation of the outcome of consecutive patients after a valve-in-valve TAVI [transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV)] as compared to a standard reoperation [surgical aortic valve redo-operation (SAV-in-SAV)] has not yet been performed. The goal of this study was to compare postoperative outcomes after TAV-in-SAV and SAV-in-SAV in a single center setting.All SAV-in-SAV and TAV-in-SAV patients from January 2001 to October 2014 were retrospectively reviewed. Patients with previous mechanical or transcatheter valves, active endocarditis and concomitant cardiac procedures were excluded. Patient characteristics, preoperative data, post-procedural complications, and 30-day mortality were collected from a designated database. Mean values ± SD were calculated for all continuous variables. Counts and percentages were calculated for categorical variables. The Chi-square and Fisher exact tests were used to compare categorical variables. Continuous variables were compared using the t-test for independent samples. A 2-sided P value0.05 was considered statistically significant.A total of 102 patients fulfilled the inclusion criteria, 50 patients (49%) underwent a transcatheter valve-in-valve procedure, while 52 patients (51%) underwent redo-surgery. Patients in the TAV-in-SAV group were significantly older, had a higher mean logistic EuroSCORE and exhibited a lower mean left ventricular ejection fraction than patients in the SAV-in-SAV group (78.1±6.7 vs. 66.2±13.1, P0.001; 27.4±18.7 vs. 14.4±10, P0.001; and 49.8±13.1 vs. 56.7±15.8, P=0.019 respectively). Postoperative pacemaker implantation and chest tube output were higher in the SAV-in-SAV group compared to the TAV-in-SAV group [11 (21%) vs. 3 (6%), P=0.042 and 0.9±1.0 vs. 0.6±0.9, P=0.047, respectively]. There was no significant difference in myocardial infarction, stroke or dialysis postoperatively. Thirty-day mortality was not significantly different between the two groups [TAV-in-SAV2 (4%) vs. SAV-in-SAV0, P=0.238]. Kaplan-Meier (KM) 1-year survival was significantly lower in the TAV-in-SAV group than in the SAV-in-SAV group (83% vs. 96%, P0.001).The present investigation shows that both groups, irrespective of different baseline comorbidities, show very good early clinical outcomes. While redo surgery is still the standard of care, a subgroup of patients may profit from the transcatheter valve-in-valve procedure.

With great interest, we read the recent paper by Del Trigo et al. [(1)][1], being the first study to systematically scrutinize valve hemodynamic deterioration (VHD) in a multicenter cohort of patients after transcatheter aortic valve replacement (TAVR). Because there is some evidence suggesting

Redo surgery for degeneration of biological aortic valve prostheses can be a high-risk procedure. Transcatheter aortic valve-in-valve implantation poses a less-invasive treatment alternative for these patients. We aim to present our clinical outcomes of consecutive patients after a valve-in-valve

AIMS Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. METHODS AND RESULTS From 05/2014 to 03/2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalisation after 1 year. Among 746 patients included (78.5 years [IQR 72.0-83.0], EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with ten different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (N = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. CONCLUSION This registry included the largest number of patients treated with TMVI to date. TMVI with ten dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes. This article is protected by copyright. All rights reserved.