The two most common organisms found in infective endocarditis following transcatheter aortic valve implantation (TAVI-IE) are
(EC-IE) and
(SC-IE). We aimed to compare clinical characteristics and ...outcomes of patients with EC-IE and SC-IE.
TAVI-IE patients from 2007 to 2021 were included in this analysis. The 1-year mortality was the primary outcome measure of this retrospective multi-center analysis.
Out of 163 patients, 53 (32.5%) EC-IE and 69 (42.3%) SC-IE patients were included. Subjects were comparable with regard to age, sex, and clinically relevant baseline comorbidities. Symptoms at admission were not significantly different between groups, except for a lower risk for presenting with septic shock in EC-IE than SC-IE. Treatment was performed in 78% by antibiotics alone and in 22% of patients by surgery and antibiotics, with no significant differences between groups. The rate of any complication, in particular heart failure, renal failure, and septic shock during treatment for IE, was lower in EC-IE compared with SC-IE (
< 0.05). In-hospital (EC-IE: 36% vs. SC-IE: 56%,
= 0.035) and 1-year mortality (EC-IE: 51% vs. SC-IE: 70%,
= 0.009) were significantly lower in EC-IE compared with SC-IE.
EC-IE, compared with SC-IE, was associated with a lower morbidity and mortality. However, absolute numbers are high, a finding that should trigger further research in appropriate perioperative antibiotic management and improvement of early IE diagnosis in the case of clinical suspicion.
Die hochgradige Aortenklappenstenose ist die häufigste therapiebedürftige Klappenerkrankung in Europa. Mit steigendem Lebensalter geht ein erhöhtes operatives Risiko einher, sodass sich der ...minimalinvasive, transferorale Transkatheteraortenklappenersatz (TAVI) in den letzten Jahren zu einem etablierten Therapieverfahren entwickelte. Mit steigendem Alter erhöht sich ebenfalls die Prävalenz eines Vorhofflimmerns, woraus sich in der Regel die Indikation zur oralen Antikoagulation ergibt. Der Umgang mit einer oralen Antikoagulation in einem periinterventionellen Setting bei TAVI steht im Spannungsfeld von erwartetem Blutungs- und thrombembolischem Risiko. In dieser Arbeit wurden retrospektiv anhand eines monozentrischen Registers am Herzzentrum Leipzig unterschiedliche Antikoagulationsregime in Hinblick auf einen kombinierten Sicherheitsendpunkt anhand der VARC 2 Kriterien nach 30 Tagen und die 1-Jahresmortalität untersucht.:1 Einleitung
1.1 Prävalenz und Prognose der Aortenklappenstenose
1.2 Ätiologie und Pathogenese der Aortenklappenstenose
1.3 Therapiemöglichkeiten der hochgradigen Aortenklappenstenose
1.3.1 medikamentöse Therapie
1.3.2 perkutane Ballonvalvuloplastie
1.3.3 offen- chirurgischer Aortenklappenersatz
1.3.4 interventioneller Aortenklappenersatz
1.4 Therapieplanung zur Behandlung der Aortenklappenstenose
1.5 Vorhofflimmern als Komorbidität
1.5.1 Rationale zur oralen Antikoagulation und Risikostratifizierung
bei Vorhofflimmern
1.6 orale Antikoagulation
1.6.1 Vitamin K Antagonisten
1.6.2 Direkte orale Antikoagulanzien
1.7 Periinterventioneller Umgang mit einer oralen Antikoagulation
1.8 Komplikationen bei TAVI Eingriffen
1.8.1 zerebral-embolische Komplikationen
1.8.2 Blutungskomplikationen
1.9 Einordnung von periprozeduralen Komplikationen anhand der
VARC-2 Kriterien
1.10 Aufbau des TAVI Registers am Herzzentrum Leipzig
1.11 Datenerhebung
1.12 Zielsetzung
2 Publikationsmanuskript
2.1 Allgemeine Information
2.2 Manuskript
3 Zusammenfassung
The role of continued versus interrupted oral anticoagulation (OAC) in patients with atrial fibrillation (AF) who underwent transfemoral transcatheter aortic valve implantation (TF-TAVI) for severe ...aortic stenosis is uncertain. The aim of this retrospective investigation was to evaluate the impact (1) of continued versus interrupted OAC on early safety and (2) of postoperative anticoagulant management on the 1-year mortality in patients with AF who underwent TF-TAVI. Consecutive patients with AF and on OAC at admission (n = 598) were stratified according to interrupted (iVKA) versus continued vitamin K antagonist (cVKA) versus continued direct oral anticoagulants (DOAC) at the time of TF-TAVI. Valve Academic Research Consortium-2 early safety was the primary outcome measure. Patients with iVKA (n = 299), cVKA (n = 117), and DOAC (n = 182) had comparable baseline characteristics including age (p = 0.25), gender (p = 0.33), and STS-Score (p = 0.072). The proportion of patients having a CHA2DS2-VASc-Score ≥3 (p = 0.791) and HAS-BLED-Score ≥3 (p = 0.185) was not different between groups. The rate of early safety events (with lower values indicating superior safety) was lowest in DOAC (13.2%) and not increased in cVKA (19.7%) compared to iVKA (23.1%) (p = 0.029). Valve Academic Research Consortium-2 defined stroke (p = 0.527) and bleeding (p = 0.097) did not differ between groups. Renal failure occurred more often in iVKA compared to cVKA and DOAC (p = 0.02). All-cause 1-year mortality was 20.1% in iVKA, 13.7% in cVKA, and 8.8% in DOAC (p = 0.015). Multivariate analysis revealed DOAC to be associated with reduced all-cause 1-year mortality (HR 0.56 (95%-CI 0.32 to 0.99), p = 0.047) whereas cVKA was comparable to iVKA (HR 0.75 (95%-CI 0.43 to 1.31), p = 0.307). In conclusion, cVKA did not increase the rate for the composite end point of early safety at 30 days in this cohort of patients. Treatment with a DOAC was associated with a significantly reduced rate of early safety end points at 30 days and lower 1-year mortality.
This study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural ...interruption of anticoagulation.
A significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown.
Consecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality.
Of 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio OR: 0.86; 95% confidence interval CI: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 13.7% vs. 130 17.7%; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36).
Continuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation.
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Vascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a ...novel option to achieve haemostasis for large-bore arterial access sites.
We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD.
From February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition.
Overall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32–0.91, p = 0.022).
The M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.
•The plug-based Manta closure device is a new option for large-bore arterial access.•Access site-related vascular complications were less frequently with the Manta device.•The ProGlide device is associated with more severe bleeding complications.
The use of bioprostheses for surgical aortic valve replacement increased substantially within the last years. In case of prosthesis failure, re-SAVR is standard of care, whereas valve-in-valve ...deployment of a transfemoral transcatheter aortic valve prosthesis (VinV-TFAVI) has recently emerged as an alternative. We sought to evaluate early safety, clinical efficacy, and all-cause 1-year-mortality of VinV-TFAVI and redo surgery for failing aortic bioprostheses (re-SAVR).
Patients receiving either VinV-TFAVI (n = 147) or re-SAVR (n = 111) for a degenerated aortic bioprosthesis between 01/2006 and 05/2017 were included in this analysis. All-cause 1-year mortality was the primary outcome measure. Early safety and clinical efficacy according to VARC-2 endpoint definitions were evaluated at 30 days.
Baseline characteristics differed significantly between both groups including age, STS-PROM, and incidence of relevant comorbidities. Re-stenosis was the predominant mode of failure in 45.9% of re-SAVR and 63.1% of VinV-TFAVI patients. The rate of “early safety” endpoints was lower with VinV-TFAVI (17.7% vs. 64.9%, p < 0.01), the rate of “clinical efficacy” endpoints was lower, e.g. better with re-SAVR (53.1% vs. 32.4%, p < 0.01). All-cause 1-year-mortality (VinV-TFAVI 8.8% vs re-SAVR 9.9%, p = 0.84) was not different. Treatment strategy was not associated with 1-year-mortality in a Cox regression analysis. The incidence of prosthesis-patient-mismatch was higher in VinV-TFAVI compared to re-SAVR.
VinV-TFAVI represents a viable alternative for treatment of degenerated aortic bioprostheses in patients at increased surgical risk. However, in patients at low risk for reoperation, a better clinical efficacy and acceptable safety may favour re-SAVR.
•VinV-TAVI is a safe and effective treatment for degenerated aortic bioprosthesis.•Data comparing this procedure to redo surgery (re-SAVR) are scarce.•Comparable 1-year-mortality between re-SAVR and VinV-TFAVI.•Incidence of bleeding and renal failure was higher with re-SAVR.•Postoperative transvalvular gradients were higher after VinV-TFAVI.
Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of ...infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR.
Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort HC: before 2014; contemporary cohort CC: after 2014).
Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all).
Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.
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