Showing papers by "Tanja K. Rudolph published in 2021"

Transcatheter mitral valve replacement after surgical repair or replacement comprehensive midterm evaluation of valve-in-valve and valve-in-ring implantation from the VIVID registry

Abstract: Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or repl...

Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR

Abstract: Objectives The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR). Background Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences. Methods In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included. Results Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement. Conclusions CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality.

Temporal trends of TAVI treatment characteristics in high volume centers in Germany 2013–2020

Abstract: To assess temporal trends of patient baseline characteristics, risk profile and outcome of transcatheter aortic valve implantation (TAVI) between 2013 and 2020. Guideline recommendations and increasing confidence in TAVI therapy may have changed the selection of TAVI patients. Baseline risk profile and VARC-2 outcome of 15,344 patients undergoing TAVI at 5 high volume centers in Germany over the time period 2013–2020 was analyzed. Over the 8 years, annual TAVI volumes more than doubled from 1071 in 2013 to 2996 in 2020. The baseline surgical risk estimated by the Society of Thoracic Surgeons (STS) score declined from 7.2 ± 6.2% to 4.6 ± 3.7% (P 8% 2013 7.5%; 2020 6.9%; P = 0.778). From 2013 to 2020, mortality and burden of complications following TAVI procedure significantly decreased in a large multicenter registry from Germany. Proportion of elderly patients remained stable, while the surgical risk profile decreased.

Incidence, Risk Factors and Impact on Long-Term Outcome of Postoperative Delirium After Transcatheter Aortic Valve Replacement.

Abstract: Background: The aim of the present study was to analyze incidence, risk factors, and association with long-term outcome of postoperative delirium (POD) after transcatheter aortic valve replacement (TAVR). Methods: Six hundred and sixty one consecutive patients undergoing TAVR were prospectively enrolled from January 2016 to December 2017. POD was assessed regularly during ICU-stay using the CAM-ICU test. Results: The incidence of POD was 10.0% (n = 66). Patients developing POD were predominantly male (65%), had higher EuroSCORE II (5.4% vs. 3.9%; P = 0.041) and were more often considered frail (70% vs. 26%; P < 0.001). POD was associated with more peri-procedural complications including vascular complications (19.7 vs. 9.4; P = 0.017), bleeding (12.1 vs. 5.4%; P = 0.0495); stroke (4.5 vs. 0.7%; P = 0.025), respiratory failure requiring ventilation (16.7% vs. 1.8%; P < 0.001), and pneumonia (34.8% vs. 7.1%; P < 0.001). Consequently, patients with POD had significantly longer ICU- (7.9 vs. 3.2 days P < 0.001) and hospital-stay (14.9 vs. 9.0 days; P < 0.001), and higher in-hospital mortality (6.1 vs. 2.1%; P = 0.017). Logistic regression analysis identified male sex (odds ratio (OR) 2.2 [95% confidence interval (CI) 1.2-4.0); P = 0.012], atrial fibrillation [OR 3.0 (CI 1.6-5.6); P < 0.001], frailty [OR 4.3 (CI 2.4-7.9); P < 0.001], pneumonia [OR 4.4 (CI 2.3-8.7); P < 0.001], stroke [OR 7.0 (CI 1.2-41.6); P = 0.031], vascular complication [OR 2.9 (CI 1.3-6.3); P = 0.007], and general anesthesia [OR 2.0 (CI 1.0-3.7); P = 0.039] as independent predictors of POD. On Cox proportional hazard analysis POD emerged as a significant predictor of 2-year mortality [HR 1.89 (CI 1.06-3.36); P = 0.030]. Conclusion: POD is a frequent finding after TAVR and is significantly associated with reduced 2-year survival. Predictors of delirium include not only peri-procedural parameters like stroke, pneumonia, vascular complications and general anesthesia but also baseline characteristics as male sex, atrial fibrillation and frailty.

Four‐year mortality in women and men after transfemoral transcatheter aortic valve implantation using the SAPIEN 3

Abstract: Objectives To investigate 4-year, post-transcatheter aortic valve implantation (TAVI) survival and predictors of survival by sex, in a real-world cohort that underwent transfemoral TAVI with SAPIEN 3 transcatheter heart valve. Background Previous TAVI investigations of first-generation devices demonstrated an early- to mid-term survival advantage in women compared with men. Methods SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) is a post-approval, multicentre, observational registry. Patients (N = 1,694, 49.2% women, age 81.7 ± 6.7 years) with severe aortic stenosis and high surgical risk (logistic EuroSCORE 17.8%) underwent TAVI between 2014 and 2015. Kaplan-Meier event estimates were used to determine mortality by sex. Predictors of overall mortality were identified using a cox multivariate proportional hazard model. Results At 4 years, women had lower all-cause mortality than men (36.0 vs 39.7%; p = .0911; HR: 0.87 [95% CI: 0.75-1.02]). No difference was observed for cardiac mortality between women 24.2% and men 24.7% (p = .76; HR: 0.97 [95% CI: 0.79-1.19]). When adjusted for baseline characteristics (age, height, weight, NYHA functional class, renal insufficiency, EuroScore, and tricuspid regurgitation), sex had no impact on mortality. Conclusions In this large, real-world cohort, all-cause mortality trended lower in women than men at 4 years post TAVI; however, several baseline factors, but not sex, were predictors of mortality. No difference between sexes was observed for cardiovascular mortality.

PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation.

Abstract: The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow’s disease. 38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint. Patient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5–85.3] years (PASCAL) and 82.5 [76.5–86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68–0.83] cm2 (PASCAL) and 0.70 [0.50–0.90] cm2 (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured. In this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.

IMPULSE: the impact of gender on the presentation and management of aortic stenosis across Europe.

Abstract: Aims There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). Methods Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age. Results Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001). Conclusions The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.

Management of patients with severe aortic stenosis in the TAVI-era: how recent recommendations are translated into clinical practice.

Abstract: Objective Approximately 3.4% of adults aged >75 years suffer from aortic stenosis (AS). Guideline indications for aortic valve replacement (AVR) distinguish between patients with symptomatic and asymptomatic severe AS. The present analysis aims to assess contemporary practice in the treatment of severe AS across Europe and identify characteristics associated with treatment decisions, namely denial of AVR in symptomatic patients and assignment of asymptomatic patients to AVR. Methods Participants of the prospective, multinational IMPULSE database of patients with severe AS were grouped according to AS symptoms, and stratified into subgroups based on assignment to/denial of AVR. Results Of 1608 symptomatic patients, 23.8% did not undergo AVR and underwent medical treatment. Denial was independently associated with multiple factors, including severe frailty (p=0.024); mitral (p=0.002) or tricuspid (p=0.004) regurgitation grade III/IV, and the presence of renal impairment (p=0.017). Of 392 asymptomatic patients, 86.5% had no prespecified indication for AVR. Regardless, 36.3% were assigned to valve replacement. Those with an indexed aortic valve area (AVA; p=0.045) or left ventricular ejection fraction (LVEF; p<0.001) below the study median; or with a left ventricular end systolic diameter above the study median (p=0.007) were more likely to be assigned to AVR. Conclusions There may be considerable discrepancies between guideline-based recommendations and clinical practice decision-making in the treatment of AS. It appears that guidelines may not fully capture the complete clinical spectrum of patients with AS. Thus, there is a need to find ways to increase their acceptance and the rate of adoption.

Comparison of Self-Expanding RDV Perceval S versus TAVI ACURATE neo/TF.

Abstract: Background Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo/TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort. Methods A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes. Results Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p = 0.752). However, higher numbers of PVL (mild-PER = 0.0% vs. NEO = 55.9%, p = 0.001; moderate or higher-PER = 0.0% vs. NEO = 6.8%, p = 0.119) after TAVI with NEO were observed. Conclusion Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL.

Coronary physiology in the catheter laboratory

Abstract: Die Regulation des koronaren Flusses erfolgt im Wesentlichen in den Widerstandsgefasen der Mikrozirkulation, sodass sich die funktionelle Relevanz einer Koronarstenose aus dem Wechselspiel zwischen Stenose und nachgeschalteter Mikrozirkulation ergibt. Diese Zusammenhange werden durch koronarphysiologische Messungen, wie die Bestimmung der iwFR („instantaneous wave-free ratio“) oder der fraktionellen Flussreserve (FFR), sehr prazise erfasst. Im Gegensatz dazu fuhren rein visuelle Beurteilungen der koronaren Anatomie oft zu Fehlinterpretationen und moglicherweise zu falschen Revaskularisationsentscheidungen. Entsprechend findet sich in den aktuellen Revaskularisierungsleitlinien der European Society of Cardiology (ESC) fur die FFR und die iwFR eine Klasse-IA-Indikation bei intermediaren Koronarstenosen mit unklarer hamodynamischer Relevanz. Dennoch wird die Methodik im klinischen Alltag oftmals nicht eingesetzt. Neben der rein hamodynamischen Beurteilung konnen neuartige Methoden wie Koregistrierung und koronares Mapping auch zur Planung einer perkutanen transluminalen Koronarangioplastie (PTCA), insbesondere bei Gefasen mit diffusen Veranderungen oder seriellen Stenosen, angewandt werden. Daruber hinaus stratifiziert die invasive Flussmessung auch zwischen konservativ und interventionell zu behandelnden Patienten im akuten Koronarsyndrom, bei denen im Vergleich zur stabilen koronaren Herzkrankheit weitere Faktoren der Flusslimitation wie Spasmus, Thrombus und akute Mikrozirkulationsstorungen hinzukommen.

Valve-in-Valve TAVR versus Redo Surgical Aortic Valve Replacement: Early Outcomes.

Abstract: OBJECTIVE This study aimed to assess short-term outcomes of patients with failed aortic valve bioprosthesis undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) or redo surgical aortic valve replacement (rSAVR). METHODS Between 2009 and 2019, 90 patients who underwent ViV-TAVR (n = 73) or rSAVR (n = 17) due to failed aortic valve bioprosthesis fulfilled the inclusion criteria. Groups were compared regarding clinical end points, including in-hospital all-cause mortality. Patients with endocarditis and in a need of combined cardiac surgery were excluded from the study. RESULTS ViV-TAVR patients were older (78.0 ± 7.4 vs. 62.1 ± 16.2 years, p = 0.012) and showed a higher prevalence of baseline comorbidities such as atrial fibrillation, diabetes mellitus, hyperlipidemia, and arterial hypertension. In-hospital all-cause mortality was higher for rSAVR than in the ViV-TAVR group (17.6 vs. 0%, p < 0.001), whereas intensive care unit stay was more often complicated by blood transfusions for rSAVR patients without differences in cerebrovascular events. The paravalvular leak was detected in 52.1% ViV-TAVR patients compared with 0% among rSAVR patients (p < 0.001). CONCLUSION ViV-TAVR can be a safe and feasible alternative treatment option in patients with degenerated aortic valve bioprosthesis. The choice of treatment should include the patient's individual characteristics considering ViV-TAVR as a standard of care.

Transkatheter-Herzklappen: welche Prothese für welchen Patienten?

Abstract: Seit Einfuhrung der Transkatheter-Aortenklappenimplantation (TAVI) zur Behandlung von Aortenklappenvitien gab es eine immense Entwicklung der Indikationen, Implantationsmethoden und der verfugbaren Klappenprothesen. Ziel des vorliegenden Beitrags ist, die aktuell in Deutschland auf dem Markt befindlichen, zugelassenen TAVI-Prothesen zu charakterisieren und ihre klinischen Einsatzbereiche differenziert zu beschreiben. Literaturrecherche. Diskussion aktueller Daten, gewonnen aus randomisierten und vergleichenden Studien, Serien sowie Fallberichten. Die verfugbaren TAVI-Prothesen unterscheiden sich bezuglich der Schrittmacherraten, der paravalvularen Leckagen, der Zugangswege, der Eignung in besonderen Anatomien und weiterer Eigenschaften wie der Moglichkeit eines spateren Koronarzugangs. Anhand der Eigenschaften der Prothesen lasst sich die Eignung fur individuelle Patientencharakteristika darstellen und beschreiben, dabei verbleibt jedoch eine subjektive Komponente. Direkte Prothesenvergleiche waren sinnvoll, um offene Fragen zur-Prothesenwahl zu klaren.

Beneficial effects of atrial fibrillation ablation in patients with angina pectoris and coronary sinus reducer.

Abstract: Limited data exists about the effectiveness of the coronary sinus reducer (CSR) device in patients with angina pectoris and atrial fibrillation (AF). This case demonstrates beneficial effects of AF ablation in a patient with CSR. We report four major findings: Rhythm control has a relevant effect on angina pectoris symptoms in patients with coronary artery disease and AF. In these patients, AF ablation should be considered at an early stage. Patients with persistent angina pectoris and CSR may require sinus rhythm for an optimal effect of the device. Selected coronary sinus (CS) interventions can still be performed through the mesh of the CSR device.