Publications by authors named "Sabine Bleiziffer"

168 Publications

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

Catheter Cardiovasc Interv 2021 Jul 31. Epub 2021 Jul 31.

Department of Medicine, University of Bonn, Bonn, Germany.

Objectives: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study.

Background: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce.

Methods: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients.

Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low.

Conclusions: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.
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http://dx.doi.org/10.1002/ccd.29889DOI Listing
July 2021

Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry.

J Am Coll Cardiol 2021 May;77(18):2263-2273

Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.

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.
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http://dx.doi.org/10.1016/j.jacc.2021.03.228DOI Listing
May 2021

Five-year outcome in 18 010 patients from the German Aortic Valve Registry.

Eur J Cardiothorac Surg 2021 May 4. Epub 2021 May 4.

Department of Cardiology, Campus Kerckhoff University of Giessen, Bad Nauheim, Germany.

Objectives: To determine the 5-year outcome in patients treated by isolated transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (sAVR)-a prospective observational cohort study.

Methods: A total of 18 010 patients were included (n = 8942 TAVI and n = 9068 sAVR) in the German Aortic Valve Registry (GARY) who were treated in 2011 and 2012 at 92 sites in central Germany. Eligible patients with TAVI and sAVR were matched using propensity scores in a nearest-neighbour approach. Patients with repeat procedures or unequivocal indication for one treatment option (e.g. frailty) were excluded (n = 4785 for TAVI and n = 2 for sAVR). This led to 13 223 patients (4157 TAVI and 9066 sAVR) as an unmatched subcohort. The main outcome measure was the 5-year all-cause mortality.

Results: TAVI patients were significantly older (80.9 ± 6.1 vs 68.5 ± 11.1 years, P < 0.001), had a higher Society of Thoracic Surgeons (STS) score (6.3 ± 4.9 vs 2.6 ± 3.0, P < 0.001) and a higher 5-year all-cause mortality (49.8% vs 16.5%, P < 0.0001). There was no major difference in in-hospital stroke, in-hospital myocardial infarction, or temporary and chronic dialysis. In the propensity score-matched group (n = 3640), there were 763 deaths (41.9%) among 1820 TAVI patients compared with 552 (30.3%) among 1820 treated with sAVR during the 5-year follow-up (hazard ratio 1.51, 95% confidence interval 1.35-1.68; P < 0.0001). New pacemaker implantation was performed in 448 patients (24.6%) after TAVI and in 201 (11.0%) after sAVR (P < 0.0001).

Conclusions: The 5-year follow-up data show that TAVI patients were significantly older and had a higher STS score than sAVR patients. After propensity score matching, TAVI with early-generation prosthesis was associated with significantly higher 5-year all-cause mortality than sAVR.
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http://dx.doi.org/10.1093/ejcts/ezab216DOI Listing
May 2021

Papillary Muscle Heads Focalization for Functional Mitral Regurgitation with Severe Tethering.

Thorac Cardiovasc Surg 2021 Apr 8. Epub 2021 Apr 8.

We performed "Papillary muscle heads focalization" for three patients with severe functional mitral regurgitation with severe leaflet tethering (coaptation distance ≥1 cm and/or posterior leaflet angle ≥45 degrees). All separated papillary muscle heads were sutured together and both the anterolateral and posteromedial papillary muscles were reconstructed as single head papillary muscles. The stitches are positioned to adjust the levels of mitral leaflet tips, concerning the length of the marginal chordae connected to each head. A downsized annuloplasty is performed concomitantly. At discharge, no patient showed moderate/severe mitral regurgitation. Their coaptation lengths were 7.1, 8.5, and 8.3 mm.
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http://dx.doi.org/10.1055/s-0040-1722730DOI Listing
April 2021

Effects of a dual-filter-based cerebral embolic protection device in transcatheter aortic valve replacement on cerebral oxygen saturation: A prospective pilot study.

J Card Surg 2021 Apr 23;36(4):1241-1248. Epub 2021 Jan 23.

Department of Anaesthesiology, German Heart Center Munich, Technische Universität München, Munich, Germany.

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 (rSO ) was continuously measured with near-infrared spectroscopy (NIRS). The cumulative perioperative cerebral desaturation was calculated for each patient by multiplying rSO below an individualized desaturation threshold by time. In addition, rSO 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 rSO 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.
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http://dx.doi.org/10.1111/jocs.15355DOI Listing
April 2021

Impact of chronic kidney disease in 29 893 patients undergoing transcatheter or surgical aortic valve replacement from the German Aortic Valve Registry.

Eur J Cardiothorac Surg 2021 04;59(3):532-544

German Center for Cardiovascular Research, DZHK, Partner Site Rhine-Main, Rhine-Main, Germany.

Objectives: Chronic kidney disease (CKD) is a key risk factor in patients undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). We analysed the impact of estimated glomerular filtration rate (eGFR) and CKD stages on their mid-term survival.

Methods: Data from 29 893 patients enrolled in the German Aortic Valve registry from January 2011 to December 2015 receiving TAVI (n = 12 834) or SAVR (n = 17 059) at 88 sites were included. The impact of renal impairment, as measured by eGFR and CKD stages, was investigated. The primary end-point was 1-year cumulative all-cause mortality.

Results: Higher CKD stages were significantly associated to lower in-hospital, 30-day- and 1-year survival rates. Both TAVI- and SAVR-treated patients in CKD 3a, 3b, 4 and 5 stages showed significant and gradually increasing HR values for 1-year all-cause mortality. The same trend persisted in multivariable analysis, although HR values for CKD 3a and 5 did not reach significance in TAVI patients, whereas CKD 4 + 5 did not reach statistical significance in SAVR. Likewise, eGFR as a continuous variable was a significant predictor for 1-year mortality, with the best cut-off points being 47.4 ml/min/1.73 m2 for TAVI and 59.8 ml/min/1.73 m2 for SAVR. Significant 8.6% and 9.0% increases in 1-year mortality were observed for every 5-ml reduction in eGFR for TAVI and SAVR, respectively.

Conclusions: CKD ≥3b and CKD ≥3a are the independent major risk factors for mortality in patients undergoing TAVI and SAVR, respectively. In the overall population of patients with severe aortic stenosis, an appropriate stratification based on CKD substage may contribute to a better selection of patients suitable for such therapies.
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http://dx.doi.org/10.1093/ejcts/ezaa446DOI Listing
April 2021

Transcatheter Versus Rapid-Deployment Aortic Valve Replacement: A Propensity-Matched Analysis From the German Aortic Valve Registry.

JACC Cardiovasc Interv 2020 11;13(22):2642-2654

Department of Cardiac Surgery, University Hospital Lübeck, Lübeck, Germany.

Objectives: This study sought to compare patient characteristics, procedural outcomes, and valve hemodynamics of surgical aortic valve replacement (SAVR) with current-generation rapid-deployment valves (RDVs) versus transcatheter aortic valve replacement (TAVR) with current-generation transcatheter heart valves (THVs).

Background: The patient population currently treated with RDVs may have potential similarities with the current TAVR population, but comparative studies in a large patient population remain scarce.

Methods: A total of 16,473 patients who underwent isolated SAVR using current-generation RDVs or isolated transfemoral TAVR with current-generation THVs between 2011 and 2017 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for RDVs and THVs before and after 1:1 propensity score matching. Furthermore, RDVs and THVs with similar design characteristics were compared with each other.

Results: A total of 1,743 patients received SAVR with an RDV, whereas 14,730 patients were treated with transfemoral TAVR. Patients treated with TAVR were significantly older and had higher surgical risk scores. Following valve replacement, patients treated with an RDV had a significantly higher rate of disabling stroke (1.7% vs. 1.1%; p = 0.03), need for transfusion of >4 red blood cell units (8.5% vs. 1.4%; p < 0.001), and new onset renal replacement therapy (1.9% vs. 1.2%; p = 0.01), whereas the need for a new permanent pacemaker was lower (8.4% vs. 14.9%; p < 0.001). In-hospital mortality was similar (1.6% vs. 1.8%; p = 0.62). These findings persisted after 1:1 propensity score matching, but in-hospital mortality was significantly higher after RDVs (1.7% vs. 0.6%; p = 0.003). Balloon-expandable (BE) RDVs had significantly lower residual gradients compared with BE-THVs, while self-expanding (SE)-RDVs had significantly higher residual gradients compared with SE-THVs.

Conclusions: In a large all-comers' registry, TAVR with current-generation THVs was associated with improved in-hospital outcomes compared with SAVR with current-generation RDVs. The pacemaker rate is significantly higher with TAVR. Post-procedural hemodynamic function varied between individual RDVs and THVs.
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http://dx.doi.org/10.1016/j.jcin.2020.09.018DOI Listing
November 2020

Contemporary management of severe symptomatic bicuspid aortic valve stenosis: the BiTri Registry.

J Cardiovasc Med (Hagerstown) 2021 Jun;22(6):492-495

Clinique Pasteur, Toulouse, France.

Aims: A greater number of patients with bicuspid aortic valves (BAV) may be identified and treated as indications for transcatheter aortic valve implantation (TAVI) are expected to expand to younger patients. We evaluated the contemporary frequency and management of symptomatic patients with stenotic BAV in a multicenter European registry.

Methods: Between November 2017 and February 2018, all consecutive patients admitted for symptomatic aortic stenosis across six high-volume European hospitals were prospectively enrolled in the BiTri registry.

Results: Of the 832 patients, 17% (n = 138) had a BAV. The most frequent BAV phenotypes were type 1 (left--right coronary cusps fusion 64%) and type 1 (right-noncoronary cusps fusion 17%). Type 0 and type 2 accounted for 12 and 2%, respectively. When compared with tricuspid patients (n = 694), BAV patients were younger, with lower surgical risk. The transthoracic echocardiography (TTE) identified BAV in 64% of patients. Multisliced computed tomography (MSCT) additionally completed the diagnosis in 20% of patients. Surgical inspection finally identified the remaining undiagnosed 16% of BAV. A combination of TTE and MSCT was the most common diagnosis method for BAV. Surgical aortic valve replacement (SAVR) was the predominant therapeutic option for BAV (70%) whilst TAVI was performed in 26%.

Conclusion: BAV is frequently observed in symptomatic patients with aortic stenosis. These patients are younger, have a lower risk profile and are predominantly treated with SAVR as compared with tricuspid patients. However, TAVI is performed in almost one-third of BAV patients in contemporary European practice. TTE combined with MSCT identified 84% of BAV.
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http://dx.doi.org/10.2459/JCM.0000000000001134DOI Listing
June 2021

Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial.

Circulation 2020 Dec 15;142(25):2431-2442. Epub 2020 Oct 15.

Department of General Surgery and Medical-Surgical Subspecialties, University of Catania, Italy (C.T., D.C.).

Background: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement.

Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days.

Results: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; =0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; =0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; =0.03) and 1 year (8.4% versus 3.9%; =0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; =0.002) were significantly increased in the ACURATE neo group.

Conclusions: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.051547DOI Listing
December 2020

Long-Term Clinical Outcome in Elderly Patients Undergoing Mitral Valve Repair.

Thorac Cardiovasc Surg 2020 Sep 30. Epub 2020 Sep 30.

Department of Cardio-Thoracic Surgery, Heart and Diabetes Center North Rhine Westphalia, Bad Oeynhausen, Nordrhein-Westfalen, 32545, Germany.

Background:  Long-term data on patients over 75 years undergoing mitral valve (MV) repair are scarce. At our high-volume institution, we, therefore, aimed to evaluate mortality, stroke risk, and reoperation rates in these patients.

Methods:  We investigated clinical outcomes in 372 patients undergoing MV repair with ( = 115) or without ( = 257) tricuspid valve repair. The primary endpoint was the probability of survival up to a maximum follow-up of 9 years. Secondary clinical endpoints were stroke and reoperation of the MV during follow-up. Univariate and multivariable Cox regression analysis was performed to assess independent predictors of mortality. Mortality was also compared with the age- and sex-adjusted general population.

Results:  During a median follow-up period of 37 months (range: 0.1-108 months), 90 patients died. The following parameters were independently associated with mortality: double valve repair (hazard ratio, confidence interval [HR, 95% CI]: 2.15, 1.37-3.36), advanced age (HR: 1.07, CI: 1.01-1.14 per year), diabetes (HR: 1.97, CI: 1.13-3.43), preoperative New York Heart Association (NYHA) functional class (HR: 1.41, CI: 1.01-1.97 per class), and operative creatinine levels (HR: 1.32, CI: 1.13-1.55 per mg/dL). The risk of stroke in the isolated MV and double valve repair groups at postoperative year 5 was 5.0 and 4.1%, respectively ( = 0.65). The corresponding values for the risk of reoperation were 4.0 and 7.0%, respectively ( = 0.36). Nine-year survival was comparable with the general population (53.2 vs. 53.1%).

Conclusion:  Various independent risk factors for mortality in elderly MV repair patients could be identified, but overall survival rates were similar to those of the general population. Consequently, our data indicates that repairing the MV in elderly patients represents a suitable and safe surgical approach.
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http://dx.doi.org/10.1055/s-0040-1716324DOI Listing
September 2020

TAVR in Patients on Hemodialysis: Outcome of A High-Risk Patient Group.

Heart Surg Forum 2020 Aug 28;23(5):E611-E616. Epub 2020 Aug 28.

Department of Cardiovascular Surgery, German Heart Center Munich, TUM, Munich, Germany.

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.
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http://dx.doi.org/10.1532/hsf.3129DOI Listing
August 2020

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.

Circulation 2021 Jan 25;143(2):104-116. Epub 2020 Sep 25.

Escola Paulista de Medicina - Universidade Federal de São Paulo, São Paulo, Brazil (M.Simonato, J.H.P., D.F.G.).

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 replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR.

Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate.

Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; <0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; =0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; =0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; =0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; <0.001) were both independently associated with repeat mitral valve replacement.

Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.049088DOI Listing
January 2021

Transcatheter or surgical aortic valve implantation in chronic dialysis patients: a German Aortic Valve Registry analysis.

Clin Res Cardiol 2021 Mar 23;110(3):357-367. Epub 2020 Sep 23.

Department of Cardiology, University Hospital Frankfurt am Main, Frankfurt, Germany.

Objectives: The aim of this study was to compare outcomes of transcatheter and surgical aortic valve implantation in chronic dialysis patients with aortic valve stenosis (AS).

Background: Chronic dialysis patients undergoing heart valve surgery are at higher risk for morbidity and mortality. Whether interventional techniques can reduce this risk is unclear because dialysis patients have thus far been excluded from randomized trials.

Methods: Chronic dialysis patients with AS enrolled in the German Aortic Valve Registry (GARY) between 2012 and 2015 were analyzed to compare transcatheter aortic valve implantation (TAVI n = 661) with surgical aortic valve replacement (SAVR n = 457). Propensity scores for inverse probability of treatment weighting (IPTW) were used to adjust the comparison of the two treatment groups for potential confounders.

Results: TAVI patients were older (78 ± 7.3 vs. 69 ± 10.2 years, p < 0.01, unadjusted) and had more comorbidities. Mortality at 1 year was the same (TAVI: 33.4% vs. SAVR 35.0%, p = 0.72, IPTW-adjusted) while it was lower with TAVI at 30 days (8.6% vs. 15.0%, p = 0.02, IPTW-adjusted). TAVI patients required more pacemaker implantation and showed more aortic regurgitation. SAVR patients required more blood transfusions and had longer hospital stay. Diabetes mellitus, atrial fibrillation, previous PCI, urgent procedure and EuroSCORE were associated with elevated 30-day mortality. Atrial fibrillation and older age were independent risk factor of 1-year mortality in both groups.

Conclusions: Chronic dialysis patients with AS undergoing TAVI or SAVR had the same 1-year mortality, although survival at 30 days was better with TAVI. These results suggest that TAVI may improve peri-procedural outcomes.
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http://dx.doi.org/10.1007/s00392-020-01717-7DOI Listing
March 2021

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

Catheter Cardiovasc Interv 2021 04 4;97(5):876-884. Epub 2020 Sep 4.

Department of Cardiothoracic Surgery, King's College Hospital, London, UK.

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.
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http://dx.doi.org/10.1002/ccd.29257DOI Listing
April 2021

Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2020 09;76(9):1018-1030

Structural Heart Division, University Heart Center, Hamburg, Hamburg, Germany.

Background: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials.

Objectives: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices.

Methods: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications.

Results: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016).

Conclusions: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).
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http://dx.doi.org/10.1016/j.jacc.2020.07.005DOI Listing
September 2020

Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves.

Eur Heart J 2020 08;41(29):2731-2742

Dipartimento di Scienze Cardiologiche Toraciche e Vascolari, Università degli Studi di Padova, Via Giustiniani, 2 - 35128 Padova, Italy.

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.
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http://dx.doi.org/10.1093/eurheartj/ehaa544DOI Listing
August 2020

Prognostic Impact of Underweight (Body Mass Index <20 kg/m) in Patients With Severe Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Implantation or Surgical Aortic Valve Replacement (from the German Aortic Valve Registry [GARY]).

Am J Cardiol 2020 08 13;129:79-86. Epub 2020 May 13.

Clinic for Thoracic and Cardiovascular Surgery, Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany.

According to the Valve Academic Resortium, underweight is one parameter in the definition of frailty, which is associated with increased mortality after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). Aims of our study were (1) to examine the impact of underweight on mortality after TAVI and SAVR and (2) to determine the effect of intervention mode (TAVI vs SAVR) on mortality in underweight patients from the German Aortic Valve Registry. Overall, 35,109 patients treated with TAVI or SAVR were studied. Outcomes of underweight (body mass index [BMI] <20 kg/m) TAVI and SAVR patients were compared using propensity score weighting. Prevalence of underweight was 5.7% in patients who underwent TAVI and 2.9% in patients who underwent SAVR. Underweight patients had significantly increased mortality rates for both treatment strategies compared with normal weight patients (BMI 20 to 30 kg/m). Comparing underweight TAVI and SAVR-patients using propensity score weighting, no statistically significant differences regarding mortality rates were observed. Subgroup analysis of severely underweight patients (BMI <18.5 kg/m²) revealed no significant increase of mortality after TAVI compared with underweight patients (BMI <20 kg/m), whereas severely underweight SAVR patients showed twofold increased mortality rates. In conclusion, underweight in patients who underwent TAVI or SAVR is rare, but it is associated with increased mortality. Especially severely underweight SAVR patients showed excess mortality rates.
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http://dx.doi.org/10.1016/j.amjcard.2020.05.002DOI Listing
August 2020

Insights on Embolic Protection, Repositioning, and Stroke: A Subanalysis of the RESPOND Study.

J Interv Cardiol 2020 17;2020:3070427. Epub 2020 May 17.

Erasmus University Medical Center, Office Bd 171-'s Gravendijkwal 230 3015 CE, Rotterdam, Netherlands.

RESPOND is a prospective, single-arm study enrolling 1014 transcatheter aortic valve replacement (TAVR) patients. The objective of this analysis is to assess the impact of cerebral embolic protection (CEP) devices and prosthetic valve repositioning on the risk of neurologic complications in patients treated with the fully repositionable Lotus Valve in the RESPOND postmarket study. Valve repositioning and CEP use were at the operators' discretion. Stroke events were adjudicated by an independent medical reviewer. This analysis assessed the baseline differences among patients according to CEP use and valve repositioning and evaluated the neurological complications at 72 hours after TAVR, hospital discharge, and 30-day follow-up. A multivariate analysis was performed to identify the potential predictors of stroke. Of the 996 patients implanted with the Lotus Valve (mean age: 80.8 years, 50.8% female, STS score 6.0 ± 6.9), 92 cases (9.2%) used CEP. The overall rate of acute stroke/transient ischemic attack (TIA) was 3.0% at 72 hours after TAVR. The 72-hour stroke/TIA rate was 1.1% in patients who had CEP and 3.2% in those who did not. Use of CEP was associated with a 2.1% absolute reduction in the risk of acute neurological events (relative risk reduction: 65.6%), although the difference was not statistically significant (=0.51). Repositioning of the Lotus Valve occurred in 313/996 procedures (31.4%). The 72-hour rate of stroke/TIA was similar in patients who had valve repositioning (2.9%) compared with those who did not (3.1%; =0.86). The selective use of a CEP device in the RESPOND study was associated with a nonsignificantly lower risk for stroke within 72 hours. The use of the repositioning feature of the Lotus Valve did not increase the stroke risk.
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http://dx.doi.org/10.1155/2020/3070427DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251468PMC
November 2020

Daytime Variation in Aortic Valve Surgery and Clinical Outcome: A Propensity Score-Matched Analysis.

Ann Thorac Surg 2020 08 9;110(2):558-566. Epub 2020 Jan 9.

Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Bad Oeynhausen, Germany.

Background: Time of day potentially impacts outcomes in cardiac surgery. Therefore, the goal of this study was to assess whether elective aortic valve replacement surgery performed in the morning versus the afternoon is associated with differences in risk-adjusted morbidity and mortality.

Methods: We performed a propensity score-matched analysis on 2720 consecutive patients (1360 pairs) who underwent elective aortic valve replacement with or without coronary artery bypass grafting at our institution between July 2009 and December 2016. The primary endpoint was a composite of death, myocardial infarction, or heart failure up to a maximum follow-up of 500 days. Secondary endpoints were perioperative troponin concentrations and in-hospital mortality.

Results: The primary endpoint did not differ between the morning surgery group (8.5%; n = 113) and the afternoon surgery group (8.4%, n = 111), with a hazard ratio for the morning surgery group (reference: afternoon surgery group) of 1.01 (95% confidence interval, 0.78-1.32; P = .93). Event risks of the components of the primary endpoint were also similar between the study groups (all P > .05). The postoperative troponin decline was slightly more pronounced in the morning surgery group than in the afternoon surgery group (P < .001), whereas in-hospital mortality was similar between study groups (P > .99).

Conclusions: In our propensity score-matched analysis on 2720 patients undergoing elective isolated aortic valve replacement or combined aortic valve replacement and coronary artery bypass grafting, time of day variation had no significant impact on clinical outcomes. Thus our study refutes the need to consider the timing of elective aortic valve surgery to improve clinical outcomes.
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http://dx.doi.org/10.1016/j.athoracsur.2019.11.026DOI Listing
August 2020

Patient eligibility for application of a two-filter cerebral embolic protection device during transcatheter aortic valve implantation: does one size fit all?

Interact Cardiovasc Thorac Surg 2020 04;30(4):605-612

Department of Cardiovascular Surgery, German Heart Centre Munich, Technische Universität München, Munich, Germany.

Objectives: This study sought to determine the percentage of patients potentially eligible for implantation of the Sentinel™ Cerebral Protection System (Sentinel-CPS) during transcatheter aortic valve implantation (TAVI) and to identify the reasons for treatment exclusion.

Methods: We retrospectively performed an analysis of pre-TAVI multislice computed tomography (MSCT) aortograms and data review of all patients undergoing a TAVI procedure in 2017 (n = 317). MSCT evaluation included the assessment of aortic arch anatomy and the vascular dimensions of the brachiocephalic and left common carotid artery. Data analysis focused on comorbid conditions, precluding 6-Fr sheath radial access and filter deployment due to history of previous artery interventions.

Results: MSCT and data analysis showed Sentinel-CPS compatibility in 61.5% of patients (n = 195). Sentinel-CPS would have been contraindicated in 38.5% (n = 122) due to one or more of the following: (i) measured diameters of the filter-landing zones <9 or >15 mm in the brachiocephalic artery and <6.5 or >10 mm in the left common carotid artery (n = 116; 88 with carotid dimensions too small); (ii) significant subclavian artery stenosis (n = 4) or an aberrant subclavian artery (n = 3) precluding Sentinel-CPS implantation and (iii) clinical characteristics including hypersensitivity to nickel-titanium (n = 1), radial artery occlusion (n = 1) or previous left common carotid artery interventions (n = 5).

Conclusions: MSCT and clinical data supported Sentinel-CPS compatibility in 61.5% of patients. The most common reason for treatment exclusion was inappropriate diameter within the target landing zone of the left carotid artery. Future device development should address this limitation.
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http://dx.doi.org/10.1093/icvts/ivz306DOI Listing
April 2020

[Interventional Aortic Valve Treatment - Update and Challenges 2019].

Dtsch Med Wochenschr 2019 11 28;144(22):1547-1552. Epub 2019 Oct 28.

Aortic valve stenosis is the most common valvular heart disease requiring treatment in Europe. Transcatheter aortic valve implantation (TAVI) has already been established as a standard therapy in patients with high but also intermediate risk.In the meantime, it is even being performed more frequently than surgical replacement in Germany.This article presents current data, indications and future challenges.
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http://dx.doi.org/10.1055/a-0832-5666DOI Listing
November 2019

Clinical experience with a novel large bore vascular closure device after transfemoral transcatheter aortic valve replacement.

EuroIntervention 2020 Jun;16(3):262-265

Department of Cardiovascular Surgery, INSURE (Institute for Translational Cardiac Surgery), German Heart Center, TUM, Munich, Germany.

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http://dx.doi.org/10.4244/EIJ-D-19-00523DOI Listing
June 2020

Current Generation Balloon-Expandable Transcatheter Valve Positioning Strategies During Aortic Valve-in-Valve Procedures and Clinical Outcomes.

JACC Cardiovasc Interv 2019 08;12(16):1606-1617

Division of Cardiac Surgery, Escola Paulista de Medicina - Universidade Federal de São Paulo, São Paulo, Brazil.

Objectives: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies.

Background: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients.

Methods: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%.

Results: A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R of 0.48 and 0.14; p < 0.001 and p = 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth.

Conclusions: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.
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http://dx.doi.org/10.1016/j.jcin.2019.05.057DOI Listing
August 2019

Transcatheter Aortic Valve Replacement Outcomes in Patients With Native vs Transplanted Kidneys: Data From an International Multicenter Registry.

Can J Cardiol 2019 09 18;35(9):1114-1123. Epub 2019 Jan 18.

Ceders Sinai Medical Centre, Los Angeles, California, USA.

Background: Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function.

Methods: This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls).

Results: The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P < 0.001), with a greater effect among RTRs than controls (P for interaction = 0.022).

Conclusion: s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs.
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http://dx.doi.org/10.1016/j.cjca.2019.01.003DOI Listing
September 2019

Impact of new pacemaker implantation following surgical and transcatheter aortic valve replacement on 1-year outcome.

Eur J Cardiothorac Surg 2020 01;57(1):151-159

Department of Internal Medicine III, University of Cologne, Cologne, Germany.

Objectives: The purpose of this study was to evaluate the incidence of new pacemaker implantation (NPMI) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), and investigate its influence on 1-year mortality.

Methods: Patients who were enrolled in 'The German Aortic Valve Registry' undergoing isolated TAVR or SAVR between 2011 and 2015 were analysed. The rate of NPMI was analysed for both groups and multivariable Cox regression analysis was performed to investigate the possible independent association between NPMI and 1-year mortality.

Results: Twenty thousand eight hundred and seventy-two patients who underwent TAVR and 17 750 patients who received SAVR were included in this study. The rate of NPMI was 16.6% after TAVR and 3.6% after SAVR. In the TAVR group, NPMI was associated with significantly increased 1-year mortality in univariable Cox regression analysis [hazard ratio (HR) 1.29, confidence interval (CI) 1.18-1.41; P < 0.001]. This association persisted after adjustment for confounding factors (HR 1.29, CI 1.16-1.43; P < 0.001). In the SAVR group, NPMI significantly increased 1-year mortality in univariable analysis as well (HR 1.55, CI 1.08-2.22; P = 0.02), whereas after multivariable adjustment, NPMI did not emerge as an independent risk factor (HR 1.29, 0.88-1.89; P = 0.19). NPMI was not associated with 30-day mortality in both procedure groups.

Conclusions: The rate of NPMI was markedly higher after TAVR compared with SAVR and was independently associated with 1-year mortality after TAVR, whereas this was not significant after SAVR. As 30-day mortality was not different for TAVR and SAVR, the subsequent procedure of an NPMI itself seems not to increase the risk of mortality.
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http://dx.doi.org/10.1093/ejcts/ezz168DOI Listing
January 2020

The Clinical Impact of Psoas Muscle Cross-Sectional Area on Medium-Term Mortality After Transcatheter Aortic Valve Implantation.

Heart Lung Circ 2020 Jun 23;29(6):904-913. Epub 2019 May 23.

Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; Department of Cardiology, Medizinische Universität Wien, Vienna, Austria. Electronic address:

Aim: Psoas muscle cross-sectional area (CSA) is a proposed marker of frailty associated with mortality after transcatheter aortic valve implantation (TAVI). We assessed the impact of psoas CSA on medium-term mortality over 5 years in a large cohort, adjusted for pre-procedural variables.

Method: This single-centre registry-derived analysis assessed 1,731 consecutive TAVI patients between 2007 and 31 April 2015 with available abdominal computed tomography scans. Sex-stratified, height-adjusted psoas CSA was measured mid-body of the fourth lumbar vertebra. Kaplan-Meier survival distributions across psoas CSA quartiles were compared. Cox and logistic regression models were used to assess baseline variables associated with the primary outcome, which was mortality within 5 years.

Results: Median age was 81 years (interquartile range, 77 - 85); 52.5% were women. The primary endpoint occurred in 555 patients over a mean follow-up of 775 days. Lower psoas CSA quartile patients were older, had a lower body mass index, lower creatinine clearance, and lower rates of previous cardiac surgery, with higher rates of diabetes, coronary artery disease, pacemaker, anaemia, hypoalbuminaemia, and higher European System for Cardiac Operative Risk Evaluation (EuroSCORE). Unadjusted survival by psoas CSA quartile was significantly different in men (log rank p=0.041) but not women (p=0.099). In Bonferroni-adjusted multivariate analysis, psoas CSA quartiles were not significantly associated with mortality. Hypoalbuminaemia (hazard ratio [HR], 2.10; 95% confidence interval [CI], 1.53 - 2.87 [p<0.001]) and increasing age (HR, 1.03 per year; 95% CI, 1.01 - 1.05 [p=0.002]) were associated with increased risk; female sex (HR, 0.63; 95% CI 0.51 - 0.78 [p<0.001]), and hypercholesterolaemia (HR, 0.67; 95%, CI 0.54 0.83 [p<0.001]) with reduced risk.

Conclusions: Psoas CSA was not significantly associated with mortality after adjusting for pre-procedural variables. Hypoalbuminaemia, sex, hypercholesterolaemia, and age were significantly associated with mortality after TAVI.
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http://dx.doi.org/10.1016/j.hlc.2019.05.095DOI Listing
June 2020

Impact of a Two-Filter Cerebral Embolic Protection Device on the Complexity and Risk of Transcatheter Aortic Valve Replacement.

Thorac Cardiovasc Surg 2020 10 15;68(7):616-622. Epub 2019 May 15.

Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany.

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 ( = 196) or Edwards Sapien 3 ( = 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 ( = 39) and without ( = 352) CS-EPD.

Results: The CS-EPD was placed through the right radial ( = 35) or brachial ( = 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,  = 0.002; 20.7 ± 9.3 vs. 13.7 ± 7 minutes, ≤ 0.001; 133.7 ± 42.6 vs. 109.7 ± 44.5 mL,  = 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;  = 0.002). There were no differences in postprocedural renal failure ( = 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.
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http://dx.doi.org/10.1055/s-0039-1688483DOI Listing
October 2020

Surgical Explantation of a Dehiscent Cardioband.

JACC Cardiovasc Interv 2019 05 27;12(9):e79-e80. Epub 2019 Feb 27.

Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany; Insure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany.

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http://dx.doi.org/10.1016/j.jcin.2018.12.038DOI Listing
May 2019

Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study.

Catheter Cardiovasc Interv 2019 05 17;93(6):1116-1123. Epub 2019 Feb 17.

Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, CE, Rotterdam, The Netherlands.

Aims: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry.

Methods And Results: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm to 1.7 ± 0.4 cm (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naïve patients was 22.2% (6/27).

Conclusions: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.
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http://dx.doi.org/10.1002/ccd.28120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593645PMC
May 2019
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