Transcatheter Aortic Valve Implantation Prosthesis Research Articles

Acurate neo2 is associated with a reduced inflammatory response in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

Inflammation following transcatheter aortic valve implantation (TAVI) is associated with an increased risk of adverse outcomes. The aim of this study was to compare the inflammatory response between low radial force valves (Acurate neo2, Boston Scientific) and high radial force valves (Evolut R/Pro, Medtronic; SAPIEN Edwards Lifesciences; and Myval, Meril valves). We conducted a retrospective study of patients with severe aortic stenosis treated with TAVI between 2021 and 2022. The primary endpoint was the difference in the inflammatory response between low radial force valves and high radial force valves, measured as the difference between post-procedural and pre-procedural high-sensitivity C-reactive protein levels (hsCRP delta). A total of 114 patients were included, of which 65 patients (57%) received a low radial force valve. The hsCRP delta was lower in the low radial force valve group compared to the high radial force valve group (8.7 [2.1-15.6] mg/L vs. 18.8 mg/dL [6.4-19] mg/L; P=0.003), due to a lower post-implantation hsCRP (8.9 [5.45-19.6] mg/L vs. 15.8 [9.8-27.3] mg/L; P=0.013). The incidence of new left bundle branch block (LBBB) after TAVI was lower in the low radial force valve group compared to the high radial force valve group (11 [17%] vs. 18 [37%]; P=0.020). Low radial force TAVI prostheses were associated with a lower inflammatory response, and a lower incidence of new LBBB compared to the radial force valve group, suggesting that inflammation may contribute to the increased risk of conduction disturbances.

Acquired Thrombocytopenia in Contemporary Transcatheter Aortic Valve Prosthesis.

Postprocedural thrombocytopenia is a known phenomenon following transcatheter aortic valve implantation (TAVI). The aim of this study is to evaluate whether postinterventional platelet kinetics differ when comparing the current generation of balloon-expandable valve (BEV) and self-expanding valve (SEV) prostheses. We performed a retrospective analysis of patients undergoing TAVI at our facility between 2017 and 2019. Patients were stratified according to the type of prosthesis used: BEV or SEV. Hematocrit-corrected platelet counts were calculated to account for dilution. Nadir platelet counts (lowest recorded platelet count), drop platelet counts (DPC; highest relative platelet drop from baseline), and severity of thrombocytopenia during the discourse and at discharge were assessed. Of the 277 included patients, 212 received SEV and 65 BEV. BEV patients were younger (81.8 ± 4.4 years vs 79.7 ± 6.8 years, p = 0.03). Further demographic characteristics were similar between groups. Implanted SEV were larger (p < 0.001) and had shorter procedural times (p < 0.01). There were no significant differences in postprocedural discourse. Postinterventional platelet drop was more pronounced in BEV patients in several evaluated metrics: mean DPC (24.3 ± 10.9% vs 18.8 ± 14.8%, p < 0.01), patients with DPC > 30% (n = 19, 29.2%, vs n = 33, 15.6%, p = 0.02), and also when comparing platelet kinetics. Despite improvements in outcome, the current generation of balloon-expandable TAVI prostheses carries a predisposition for postprocedural thrombocytopenia even when the effects of dilution are accounted for.

Valve-in-valve transcatheter aortic valve implantation for degenerative stentless versus stented surgical bioprostheses

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in failing stented bioprosthetic valves; stentless bioprostheses lack fluoroscopic markers and could be more challenging for transcatheter therapy. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce; thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of patients with stentless (SL) versus stented (ST) aortic bioprosthetic device failure undergoing ViV-TAVI. Methods Patients undergoing ViV-TAVI between 2007 and 2022 (53% of cases after 2015) at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age (SL: 77 (74; 82) vs. ST: 78 (75; 83), p=0.08), sex (male: SL 70% vs. ST 56%, p=0.08), clinically relevant baseline comorbidities and surgical risk (STS PROM SL 10.0 (4.8; 12.5) % vs. ST 9.4 (4.5; 11.3) %, p=0.62). Aortic regurgitation was the mode of failure in 33% of SL vs. 8% in ST (p&amp;lt;0.01). The rate of self-expanding TAVI prostheses was 86% and 76% in SL and ST, respectively (p=0.15). The rates of technical success (SL: 84% vs ST: 80%, p=0.55), device success (SL: 67% vs ST: 54%, p=0.11), and early safety (SL: 74% vs ST: 62%, p=0.30) were comparable between groups. There were higher rates of mild/moderate residual aortic regurgitation in SL (77.5% vs. 35%, p&amp;lt;0.01), whereas the remaining mean gradient was higher in ST (11.2 (6.0; 15.5) mmHg vs. 17.0 (11.0; 22.0) mmHg, p&amp;lt;0.01). The 30-day mortality rate (SL: 7.0% vs. ST: 2.6%, p=0.14) and Kaplan-Meier estimated 1-year mortality rates (SL: 9.3% vs. ST: 8.2%, p=0.63) were comparable between groups. Conclusion Both SL and ST ViV-TAVI have comparable short-term outcomes according to VARC-3- defined endpoints and similar low rates of 1-year all-cause mortality. However, against the background of a relevant rate of residual aortic regurgitation in SL and increased gradients in ST, long-term studies are of utmost importance to determine the clinical relevance of those factors.

Feasibility and outcome of third-generation transcatheter aortic valve implantation in patients with extra-large aortic annulus.

Many patients in need for transcatheter aortic valve implantation (TAVI) present with an aortic annulus size larger than recommended by the manufacturer's instructions for use (IFU). To investigate procedural and short-term safety and efficacy of TAVI in patients with extra-large annuli (ELA). 30-day clinical outcome and valve performance as defined by VARC 3 of 144 patients with an aortic annulus size exceeding the permitted range were compared to a propensity-score matched control cohort of patients with an aortic annulus size consistent with the IFU. Area and perimeter was 730.4 ± 53.9mm2 and 96.7 ± 6.5mm in the ELA group. Technical (96.5% vs. 94.4%) and device success (82.3% vs. 84.5%) were comparable in patients with ELA (annulus area 730.4 ± 53.9mm2) and matched controls (annulus area 586.0 ± 48.2mm2). There was no significant difference in 30-day mortality rate, major intraprocedural complications, type 3 or 4 bleedings, major vascular complications, or stroke. Moderate paravalvular leakage (PVL) occurred more frequent in the ELA group (8.9% vs 2.2%; p = 0.02). The rate of new pacemaker implantation was 7.0% in the ELA cohort and 15.0% in the control cohort, respectively (p = 0.05). Treatment of ELA patients with third-generation TAVI prostheses is feasible and safe, providing similar device success and complication rates as in matched controls with regular-sized aortic annulus. Post-interventional pacemaker implantation rates were low compared to the control group, yet incidence of moderate PVL remains problematic in ELA patients.

Comparison of oral anticoagulation by vitamin-K antagonists and non-vitamin-K antagonists for treatment of leaflet thickening after transcatheter aortic valve implantation (TAVI)

IntroductionHypoattenuated leaflet thickening (HALT), as identified by CT imaging, is not infrequent after transcatheter aortic valve implantation (TAVI). The best choice of oral anticoagulation is unknown. We compared the effectiveness of Direct Oral AntiCoagulants (DOAC) and Vitamin-K Antagonists (VKA) to resolve HALT in patients with serial CT aquisitions. MethodsA total of 46 consecutive TAVI patients in whom anticoagulation had been initiated because of HALT and who underwent follow-up CT were identified. Indication and type of anticoagulation was according to physician discretion. Patients on DOAC were compared to VKA therapy regarding resolution of HALT. ResultsMean age of the 46 patients was 80 ± 6 years (59% men), and the mean duration of anticoagulation was 156 days. Overall, 41 patients (89%) showed resolution of HALT with anticoagulation therapy, whereas HALT persisted in 5 patients (11%). Resolution of HALT was seen in 26 out of 30 (87%) patients receiving VKA and in 15 out of 16 (94%) patients receiving DOAC, respectively. Groups did not differ regarding age, cardiovascular risk factors, TAVI prosthesis type and size or duration of anticoagulation (all p > 0.05). ConclusionAnticoagulation therapy resolves leaflet thickening after TAVI in most patients. Non-Vitamin-K antagonists seem to be an effective alternative to Vitamin-K antagonists. This finding needs to be confirmed in larger prospective trials.

Permanent pacemaker implantation following transcatheter aortic valve implantation: a systematic review and Bayesian network meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Permanent pacemaker implantation (PPI) remains a common complication after transcatheter aortic valve implantation (TAVI). Different transcatheter heart valves (THVs) exist, and newly approved devices are growing. A comparison according to the mechanisms of TAVI prosthesis with longer follow-up needs to be made. We address this issue using a systematic review and a Bayesian network meta-analysis (NMA). Methods A systematic literature review was carried out up to Oct 31, 2022, to identify studies reporting the use of balloon-expandable valves (BEVs), self-expandable valves (SEVs), and mechanically expandable valves (MEVs). We compared the various THVs, or standard medical treatment (STD), with a common comparator of surgical aortic valve replacement (SAVR) concerning PPI. Data at the most extended follow-up for each study were extracted. A random-effects Bayesian NMA was used to calculate odds ratios (OR) and 95% credible intervals (CrI) using MetInsight V4.0.0. The surface under the cumulative ranking area (SUCRA) probabilities was selected to calculate the ranking and hierarchy of the different treatments. The larger SUCRA indicates the greater likelihood of becoming the best intervention. Results We included 15 RCTs comprising 12.783 patients, among whom 8.585 underwent TAVI using various commercially available THVs, including BEVs (Sapien &amp; Sapien XT, Sapien 3), MEVs (Corevalve, Evolut &amp; Pro/R, Acurate Neo, Portico), and MEVs (Lotus). The median follow-up was 2.5 years (IQR 1-5). No significant differences in the risk of PPI were observed between STD: 1.70 [0.556, 5.39], Sapien &amp; Sapien XT: 1.39 [0.834, 2.41], Sapien 3: 1.70 [0.977, 2.88], and Acurate Neo: 1.68 [0.768, 3.789], compared with SARV. All the other THVs (Corevalve: 3.07 [1.99. 4.959]; Evolut &amp; Pro/R: 3.19 [1.80, 6.03]; Lotus: 5.22 [2.08, 13.7]; Portico: 7.22 [2.85, 19.4]) showed significant differences in the risk of PPI compared with SARV. In Bayesian ranking results, Sapien &amp; Sapien XT had the highest chance (77%) of providing a lower PPI rate. Meanwhile, Portico THV was ranked the worst (5%) regarding the likelihood of PPI rate (Figure 1). According to the mechanism, all the THVs showed a higher risk for PPI than SARV (BEVs: 1.60 [1.01, 2.54]; SEVs: 3.09 [1.97, 4.96]; and MEV: 5.30 [1.62, 17.7]). STD: 1.92 [0.518, 7.14] had a non-significant PPI rate compared with SARV. SUCRA plot showed that SARV was the intervention with the lowest (95%) probability of PPI, followed by BEVs (65%), STD (55%), SEVs (27%) and MEVs (7%) (Figure 2). In both analyses, the assessment of inconsistency between direct and indirect estimates was not significant (P &amp;gt; 0.05). Conclusions This NMA of RCTs includes a more significant number of patients with longer follow-up. We demonstrated that BEVs are associated with lower PPI rates than SEVs and MEVs. Some newer generations of THVs (Acurate Neo, Evolut R/Pro) performed better than the older ones, reducing the PPI rate.

Detrimental consequences after intimal disruption of subclavian artery during transcathether aortic valve implantation

BackgroundTAVI via the left subclavian artery is considered a bail-out strategy in cases where a transfemoral approach is not feasible. However, since this route is only scarcely used, major complications can arise. We describe such an adverse course and present our proceeding.Case presentationA 65-year-old man with severe aortic valve stenosis (AS) was referred for transcatheter aortic valve implantation (TAVI) via left subclavian artery. After uneventful deployment of the TAVI prosthesis, consequent valve assessment with transeosophageal echocardiography and angiography showed a highly mobile and tubular structure shifting within the valve. We went for a surgical extraction via sternotomy on cardiopulmonary bypass (CPB). A 6 cm longish intimal cylinder was hassle-free extracted. 4 days postoperatively the left sided radial pulse was missing. In a subsequent computed tomography angiography (CTA) scan a proximal dissection as well as an intimal flap, causing a subtotal stenosis of the left subclavian artery, was detected. Consecutively the intimal cylinder was removed using a Fogarty-balloon. Pre-discharge control revealed recurrence of peripheral radial pulse and an unimpeded function of the TAVI prosthesis. The patient presented no sequela at discharge.ConclusionThough TAVI is a well-advanced technique complications are not completely avertable. It is thus advisable to have patients discussed in the heart team encompassing all potentially involved specialties.

Eight-year single-center experience with transcatheter aortic valve implantation (TAVI)

The first TAVI implantation was performed in 2002 by Cribier and colleagues. From then, we have seen significant progress in technology, with the appearance of new generations &amp;ndash; lower-profile, longer-lasting and more stable during positioning TAVI prostheses. The present publication presents single-center results and experience with TAVI procedures over an eight-year period. During the period 2013 &amp;ndash; November 2022 a total of 354 TAVI procedures were performed in Acibadem City Clinical Cardiovascular Center. Two operating strategies are used &amp;ndash; standard and minimalist approach. From the first procedure in 2013 until mid-2018 the standard approach (surgical vascular access, general anesthesia, direct valve implantation where possible) was mostly used. Then, the minimalist approach (percutaneous access, no intubation anesthesia, mandatory valve predilation and use of rapid pacing) was introduced as a standard approach in the center.

Transcatheter mitral valve replacement in native mitral valve with severe mitral annular calcification: Skirting the Sapien 3 to reduce the risk of paravalvular leaks

Mitral annular calcification (MAC) may represent a significant challenge for heart surgeons with an extremely high perioperative risk during mitral valve (MV) surgery. The risk is further increased when patients fail to be eligible for any percutaneous treatment, particularly because circumferential calcifications involving the anterior leaflet suggest a critical obstruction of the left ventricular outflow tract (LVOT). The objective of this study was to evaluate residual mitral regurgitation (MR) after surgical mitral valve replacement using a Sapien 3 Ultra (Edwards Lifesciences, CA, USA) transcatheter aortic valve implantation (TAVI) prosthesis, reinforced with a pericardial skirt, in high-risk selected patients with severe MAC. Since 2020, five high-risk patients (mean age 70 years; 63-76; four women) with severe mitral disease in the context of severe MAC (computed tomography-based mean MAC Score 8.2 ± 1.1) were operated on after we adopted this novel technique. The operations were performed under general anesthesia, using a transapical TAVI delivery system to position the Sapien 3 in the mitral position under direct vision. To reinforce and avoid paravalvular leakages, a pericardial skirt was previously sewn around the prosthesis, securing it to the annulus and perivalvular atrial surface. Sapien 3 Ultra implantation was successful without residual MR in all five patients (mild paravalvular leak in one case). Four patients had a 29-mm valve implanted, while one had a 26-mm valve implanted. Predilatation of the native annulus was never performed. Perfusion and clamping times were 134 ± 53 mins and 108 ± 43 mins, respectively. The presence of the pericardial skirt reduced the risk of leakage between the prosthesis and the rigid calcium surface, with final mean and maximal gradients of the TAVI prosthesis of 4.1 and 10.8 mmHg, respectively. There were no left ventricular outflow tract obstructions (mean LVOT gradient of 8 ± 1 mmHg). All patients were discharged, and neither mortality nor prosthetic dysfunction, nor residual mitral regurgitation was recorded. During follow-up, the last patient treated (MAC Score 10, severe calcification of the mitro-aortic junction) returned to our attention with a significant recurrent jet originating from the anterolateral commissure, currently medically treated, given the prohibitive redo risk. Direct open surgical implantation of the Sapien 3 valve can be safely done in patients with severe MAC in dedicated centers. Reinforcing the TAVI prosthesis by sewing a pericardial skirt led to satisfactory perioperative and early postoperative results, reducing paravalvular leakages. Complex anatomies have a CERTAIN risk of recurrence.

Perioperative left ventricular perforation in incomplete TAVI and completion of the procedure after surgical repair

BackgroundThe use of transcatheter aortic valve implantation (TAVI) continues to grow worldwide. Despite increased operator experience, evolution of the technique, and deflectable catheters, major complications still occur in ≤ 6% up to 8% of cases. Such major complications have been associated with a 2- to threefold increase in 30-day mortality. Complications specifically involving the aorta, aortic valve annulus, or left ventricle are rare, occurring in only 0.2–1.1% of cases.Case presentationWe report the case of a 65-year-old female patient with left ventricular lateral wall perforation during incomplete implantation of a TAVI device, and successive percutaneous completion after surgical repair of the lesion under cardiopulmonary bypass. The surgical strategy and the type of surgical treatment depend on the type of perforation. In general, repair of the lesion and aortic valve replacement are performed. Removal of the TAVI prosthesis and excision of the native aortic valve are standard parts of this repair.ConclusionHere we propose a safe alternative for the completion of the TAVI approach after surgical repair, which requires close coordination between the members of the heart team (anesthesiologist, perfusionist, cardiologist, nurse and cardiac surgeon).

How to use the aortic valve calcium score to improve the results of transcatheter aortic valve implantation with a self-expanding prosthesis

In recent years, transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI) has become the preferred method for implanting TAVI prostheses. Appropriate patient selection is important to avoid suboptimal outcomes and associated complications. To evaluate whether aortic valve calcification measured with computed tomography predicts suboptimal results from direct TAVI with a self-expanding prosthesis. Single-centre retrospective analysis of patients who received a CoreValve™ prosthesis (Medtronic, Minneapolis, MN, USA) in a direct TAVI procedure between January 2018 and March 2019. Aortic valve calcification assessment (aortic valve calcium score, calcium volume and calcium mass) was calculated from the computed tomography scan before TAVI. Procedural characteristics, need for postdilation and complications were analysed. Of 168 included patients, 18 were postdilated. Aortic valve calcium score (4259 vs. 2578; P<0.001), calcium volume (1184 vs. 647mm3; P<0.001) and calcium mass (642 vs. 368mg; P<0.001) were higher in patients needing postdilation. Aortic valve calcium score (odds ratio 9.73; P=0.004), calcium volume (odds ratio 8.48; P=0.006) and calcium mass (odds ratio 6.21; P=0.006) were independent predictors of suboptimal direct TAVI outcomes. A high aortic valvular calcium score, assessed by computed tomography scan, is an independent predictor of suboptimal prosthesis implantation outcomes in direct TAVI.

Surgical Treatment of Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation

BackgroundThe optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain. ObjectivesThe goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB). MethodsCrude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry. ResultsAmong 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HRunadj: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HRunadj: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HRadj: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HRadj: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock. ConclusionsIn this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients’ characteristics, pathogen, and IE-related complications.

High-degree atrioventricular block after valve-in-valve transcatheter aortic valve implantation: incidence and predictors

Abstract Background High-degree atrioventricular (AV) block and permanent pacemaker (PPM) implantation represent major complications after transcatheter aortic valve implantation (TAVI). Data on the incidence of AV block for patients undergoing valve-in-valve (ViV) TAVI are scarce. We examined the incidence and predictors of periinterventional AV conduction disturbances in a cohort of subjects undergoing ViV TAVI compared to subjects undergoing TAVI of native aortic valves. Methods In 50 consecutive patients who underwent ViV TAVI, clinical characteristics, incidence and predictors for AV conduction disturbances as well as intrahospital outcome were assessed. Applying a matched pair approach for age, gender, type and size of transcatheter valve, these subjects were compared to 50 patients undergoing TAVI of native tricuspid aortic valves. Results Mean age in both groups was 80±6 years and 50% of subjects were male. In the ViV group, 22 patients (44%) had a stented bioprosthesis, 10 patients (20%) a stentless bioprosthesis and 18 patients (36%) a previous TAVI prosthesis (balloon-expandable: n=15, self-expandable n=3). The majority of subjects (92% in each group) were treated using balloon-expandable valves (ViV group: Sapien XT, n=20 or Sapien 3, n=26, control group: Sapien XT, n=19 or Sapien 3, n=27). Periinterventional, non-reversible 3rd degree AV-block occurred in 6 patients within each group (12%), and all of the affected patients underwent PPM implantation. Among the 32 patients who underwent ViV-TAVI of a surgically placed bioprosthesis, only 2 (6%) developed a high-degree AV block (1/22 with a stented bioprosthesis and 1/10 with a stentless bioprosthesis). In contrast, high-degree AV block occurred in 4/18 patients (22%) who underwent ViV TAVI of a prior TAVI prosthesis. There was a significant difference in the occurrence of total high-degree AV blocks requiring postinterventional PPM implantation (p=0.033) between subjects who received TAVI of stented bioprostheses and those who received re-TAVI. In logistic regression analysis, pre-existing RBBB represented a significant predictor for periinterventional 3rd degree AV block across the whole cohort (p=0.001, Exp(B)=10.667), both in ViV subjects (p=0.016, Exp(B)=12.0) and in the control group (p=0.018, Exp(B)=10.0). Conclusion Periinterventional AV block occurs infrequently in subjects undergoing ViV TAVI for treatment of degenerated surgical bioprostheses. However, patients undergoing ViV TAVI for degenerated transcatheter prostheses as well as subjects with pre-existing RBBB are at substantial risk for the occurence of AV block and require close peri-interventional monitoring. Funding Acknowledgement Type of funding sources: None.

Comparison of direct oral anticoagulants to vitamin-K antagonists as treatment for leaflet thrombosis after Transcatheter Aortic Valve Implantation (TAVI)

Abstract Introduction Leaflet thrombosis can occur following transcatheter aortic valve implantation (TAVI). While a frequent finding in post-TAVI CT scans, leaflet thrombosis is usually clinically silent and the decision to initiate anticoagulation depends on clinical considerations. Best treatment is unknown. We compared the effectiveness of direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) to resolve leaflet thrombosis in patients with serial CT imaging following TAVI. Methods Consecutive TAVI patients who had undergone routine follow-up cardiac CT after TAVI procedures were screened for inclusion in this analysis. A total of 44 patients diagnosed with leaflet thrombosis and available follow-up CT after anticoagulation therapy were identified. Leaflet thrombosis on cardiac CT was defined as presence of hypoattenuated leaflet thickening with or without leaflet motion restriction, as previously described. The indication and type of anticoagulation was according to physician discretion. We compared patients on DOAC with patients on VKA therapy for the resolution of leaflet thrombosis. Results Mean age of the 44 patients was 80±6 years (59% men), and the median time interval from TAVI to index CT was 107 days (IQR: 91–189 days). Overall, 39 patients (90%) showed resolution of leaflet thrombosis with anticoagulation therapy, whereas leaflet thrombosis persisted in 5 patients (10%). Resolution of leaflet thrombosis was seen in 26 out of 30 (87%) patients receiving VKA and in 13 out of 14 (93%) patients receiving DOAC, respectively. Groups did not differ regarding age (p=0.97), cardiovascular risk factors (all p&amp;gt;0.1), creatinine levels (p=0.19) TAVI prosthesis type (p=0.54) and size (p=0.66). Also, no difference existed for duration of anticoagulation (median 103 vs. 110 days; p=0.76). The relative risk reduction for persisting leaflet thrombosis using DOACs was 46% in comparison to VKA, however with no statistical significance due to the limited number of patients (p=0.55). Conclusion Anticoagulation therapy resolves leaflet thrombosis after TAVI in the majority of patients. In our exploratory analysis, direct oral anticoagulants seem to be an effective alternative to vitamin-K antagonists. This result is hypothesis generating and needs to be confirmed in larger prospective trials. Funding Acknowledgement Type of funding sources: None.

Influence of deep implantation on conduction disturbances after transcatheter aortic valve implantation

HintergrundReizleitungsstörungen sind häufige Komplikationen der Transkatheter-Aortenklappenimplantation (TAVI). Ein Einflussfaktor ist die bisher nicht standardisiert bestimmte Implantationstiefe.FragestellungGibt es Unterschiede zwischen den anatomischen Regionen bei tiefer Implantation hinsichtlich neuer Reizleitungsstörungen und Überleben?Material und MethodenRetrospektive Kohortenanalyse, 420 Patienten mit transfemoraler TAVI mit Klappenprothesen der neuen Generation, davon 352 Patienten ohne vorbestehenden Schrittmacher für Analysen zur neuen Schrittmacherimplantation. Auswertung der fluoroskopisch gemessenen Implantationstiefen an der non- (NCC) und der links-koronaren Tasche (LCC) sowie der aus Patientenakten ersichtlichen Verläufe. Die tiefe Implantation definierte sich als tiefes Quartil der Implantationstiefe der jeweiligen Prothese. Das Überleben ergab sich aus einem 2‑jährigen Follow-up.Ergebnisse und DiskussionDie tiefe Implantation war nur am NCC mit erhöhter Schrittmacherimplantationsrate assoziiert (p = 0,013), am LCC mit dem häufigeren Auftreten eines permanenten Linksschenkelblocks (p = 0,014). Neue oder vorbestehende Schrittmacherimplantationen hatten keinen Einfluss auf das 2‑jährige Überleben. Eine tiefe Implantation war nicht mit einer schlechteren Überlebensprognose assoziiert. Die Implantationstiefe könnte bezüglich der Bedeutung für neue Schrittmacherimplantationen standardisiert am NCC gemessen werden. In der Eingriffsplanung könnte eine Abschätzung der Implantationstiefe am NCC oder LCC relevant für den Verlauf nach TAVI sein. Die Schrittmacherimplantation kann wie auch die tiefe Implantation am LCC oder NCC, bei Abwesenheit von mittel- bis hochgradigen paravalvulären Leckagen, als prognostisch sicher gewertet werden.

Occurrence and Persistency of Conduction Disturbances during Transcatheter Aortic Valve Implantation.

Background and Objectives: Conduction disturbances such as left bundle branch block (LBBB) and complete atrio-ventricular block (cAVB) are relatively frequent complications following trans-catheter aortic valve implantation (TAVI). We investigated the dynamics of these conduction blocks to further understand luxating factors and predictors for their persistency. Materials and Methods: We prospectively included 157 consecutive patients who underwent a TAVI procedure. Electrocardiograms (ECGs) were obtained at specific time points during the TAVI procedure and at follow-up until at least six months post-procedure. Results: Of the 106 patients with a narrow QRS complex (nQRS) before TAVI, ~70% developed LBBB; 28 (26.4%) being classified as super-transient (ST-LBBB), 20 (18.9%) as transient (T-LBBB) and 24 (22.6%) as persistent (P-LBBB). Risk of LBBB was higher for self-expandable (SE) than for balloon-expandable (BE) prostheses and increased with larger implant depth. During the TAVI procedure conduction disturbances showed a dynamic behavior, as illustrated by alternating kinds of blocks in 18 cases. Most LBBBs developed during balloon aortic valvuloplasty (BAV) and at positioning and deployment of the TAVI prosthesis. The incidence of LBBB was not significantly different between patients who did and did not undergo BAV prior to TAVI implantation (65.3% and 74.2%, respectively (p = 0.494)). Progression to cAVB was most frequent for patients with preexisting conduction abnormalities (5/34) patients) and in patients showing ST-LBBB (6/28). Conclusions: During the TAVI procedure, conduction disturbances showed a dynamic behavior with alternating types of block in 18 cases. After a dynamic period of often alternating types of block, most BBBs are reversible while one third persist. Patients with ST-LBBB are most prone to progressing into cAVB. The observation that the incidence of developing LBBB after TAVI is similar with and without BAV suggests that a subgroup of patients has a substrate to develop LBBB regardless of the procedure.

Heart valve sizing and clinical outcomes in patients undergoing transcatheter aortic valve implantation.

To investigate the impact of transcatheter heart valve (THV) sizing on procedural results and clinical outcomes following transcatheter aortic valve implantation (TAVI). The impact of individual THV sizing for patients with borderline aortic annulus anatomy remains unclear. In the prospective BernTAVI registry, THV sizing conditions were retrospectively evaluated, and patients were categorized into three groups based on the recommendations and the sizing chart of the manufacturers: optimal sizing, borderline sizing (THV size located within 5% to each border of the optimal sizing recommendation), and suboptimal sizing (THV size outside the recommended range). The latter two groups were further subcategorized into THV-oversizing and THV-undersizing. The primary endpoint was a composite of all-cause death and unplanned repeat intervention at 1year. Out of a total of 1,638 patients who underwent TAVI, 9.5 and 15.6% of patients were categorized into the borderline and suboptimal sizing group, respectively. Device success was achieved in 87.4, 88.9, and 83.6% of patients with optimal, borderline, and suboptimal sizing, respectively. The primary endpoint occurred in 12.3% of patients with optimal sizing, 14.9% of patients with borderline sizing (HRadj 1.35, 95%CI 0.87-2.09), and in 17.4% of patients with suboptimal sizing (HRadj 1.42, 95%CI 1.01-1.99). Within the suboptimal sizing cohort, unfavorable outcomes were mainly associated with THV undersizing (device success: 76.4%, primary endpoint: 23.9%, HRadj 1.98, 95%CI 1.36-2.87). Suboptimal TAVI prosthesis sizing is associated with an increased risk of all-cause death and unplanned repeat intervention within 1year largely attributable to undersized THV prostheses.

Surgical treatment of transcatheter aortic valve infective endocarditis.

There is growing interest in infections occurring after transcatheter aortic valve implantation (TAVI). The incidence, and clinical and anatomical features suggest many similarities with prosthetic valve endocarditis. The survival of patients with an infected TAVI prosthesis is generally poor; however, only a minority of them (10%) have undergone treatment with surgical explantation of the infected prosthesis. A literature search was performed using online databases. Papers reporting surgical treatment of TAVI prosthesis infections were retrieved, focusing on pre- and intraoperative characteristics and early outcome. Thirty-seven papers ultimately provided information on 107 patients. Their mean ± standard deviation (SD) age was 76 ± 8 years and 72% were male. The mean ± SD time interval between the TAVI procedure and reoperation was 10 ± 10 months. Annular abscess formation was described in 34% of cases and mitral valve involvement in 31%. All patients underwent TAVI prosthesis explantation and surgical aortic valve replacement; concomitant mitral valve replacement was necessary in 22% of cases. Postoperative in-hospital mortality was 28%. Surgical explantation of infected TAVI prostheses was associated with a high postoperative mortality, although these initial experiences included elderly and high-risk patients. Considering the expansion of TAVI procedures towards younger and lower-risk patients, surgical treatment of TAVI endocarditis may represent the best option for a life-saving procedure.Electronic supplementary materialThe online version of this article (10.1007/s12471-020-01494-y) contains supplementary material, which is available to authorized users.

Intravascular haemolysis after transcatheter aortic valve implantation with self-expandable prosthesis: incidence, severity, and impact on long-term mortality.

We aimed to determine the incidence, severity, and long-term impact of intravascular haemolysis after self-expanding transcatheter aortic valve implantation (TAVI). We believe this should be evaluated before extending the indications of TAVI to younger low-risk patients. Prospective, academic, single centre study of 94 consecutive patients treated with supra-annular self-expandable TAVI prosthesis between April 2009 and January 2014. Haemolysis at 1-year post-TAVI was defined per the published criteria based on levels of haemoglobin, reticulocyte and schistocyte count, lactate dehydrogenase (LDH), and haptoglobin. All patients had long-term clinical follow-up (6 years). The incidence of haemolysis at 1-year follow-up varied between 9% and 28%, based on different haemolysis definitions. Haemolysis was mild in all cases, no patient had markedly increased LDH levels. The presence of moderate/severe paravalvular aortic regurgitation was associated with haemolysis (7.7% vs. 23.1%, P = 0.044) and aortic valve area post-TAVI did not differ between groups with or without haemolysis (1.01 vs. 0.92 cm2/m2, P = 0.23) (definition including schistocyte count). The presence of haemolysis did not have any impact on patient prognosis after 6 years with log-rank test P = 0.80. Intravascular haemolysis after TAVI with self-expandable prosthesis is present in 9–28% of patients depending on the definition of haemolysis. The presence of haemolysis is associated with moderate/severe paravalvular aortic regurgitation but not with post-TAVI aortic valve area. Haemolysis is mild with no impact on prognosis.

Impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement with different next-generation devices

ObjectiveResidual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on...