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  • 1
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    Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1‐year results from the CHOICE‐MI registry
    Wiley ; 2022
    In:  European Journal of Heart Failure Vol. 24, No. 5 ( 2022-05), p. 887-898
    Details
    In: European Journal of Heart Failure, Wiley, Vol. 24, No. 5 ( 2022-05), p. 887-898
    Abstract: Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE‐MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. Methods and results From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge‐to‐edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI‐ineligible patients referred to bailout‐TEER, high‐risk surgery or medical therapy (MT). The primary composite endpoint was all‐cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0–83.0, EuroSCORE II 4.7% [IQR 2.7–9.7] ), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI‐ineligible patients ( n  = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout‐TEER, high‐risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout‐TEER, in 42.9% of patients undergoing high‐risk surgery and in 47.9% of patients remaining on MT. Conclusion This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI‐ineligible patients, bailout‐TEER and high‐risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.
    Type of Medium: Online Resource
    ISSN: 1388-9842 , 1879-0844
    URL: Issue
    URL: Article
    DOI: 10.1002/ejhf.v24.5
    DOI: 10.1002/ejhf.2492
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 1500332-2
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  • 2
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    Transcatheter mitral valve replacement or repair for secondary mitral regurgitation: a propensity score‐matched analysis
    Wiley ; 2023
    In:  European Journal of Heart Failure Vol. 25, No. 3 ( 2023-03), p. 399-410
    Details
    In: European Journal of Heart Failure, Wiley, Vol. 25, No. 3 ( 2023-03), p. 399-410
    Abstract: This study aimed to compare outcomes after transcatheter mitral valve replacement (TMVR) and mitral valve transcatheter edge‐to‐edge repair (M‐TEER) for the treatment of secondary mitral regurgitation (SMR). Methods and results The CHOICE‐MI registry included 262 patients with SMR treated with TMVR between 2014 and 2022. The EuroSMR registry included 1065 patients with SMR treated with M‐TEER between 2014 and 2019. Propensity score (PS) matching was performed for 12 demographic, clinical and echocardiographic parameters. Echocardiographic, functional and clinical outcomes out to 1 year were compared in the matched cohorts. After PS matching, 235 TMVR patients (75.5 years [70.0, 80.0], 60.2% male, EuroSCORE II 6.3% [interquartile range 3.8, 12.4] ) were compared to 411 M‐TEER patients (76.7 years [70.1, 80.5], 59.0% male, EuroSCORE II 6.7% [3.9, 12.4] ). All‐cause mortality was 6.8% after TMVR and 3.8% after M‐TEER at 30 days ( p  = 0.11), and 25.8% after TMVR and 18.9% after M‐TEER at 1 year ( p  = 0.056). No differences in mortality after 1 year were found between both groups in a 30‐day landmark analysis (TMVR: 20.4%, M‐TEER: 15.8%, p  = 0.21). Compared to M‐TEER, TMVR resulted in more effective mitral regurgitation (MR) reduction (residual MR ≤1+ at discharge for TMVR vs. M‐TEER: 95.8% vs. 68.8%, p   〈  0.001), and superior symptomatic improvement (New York Heart Association class ≤II at 1 year: 77.8% vs. 64.3%, p  = 0.015). Conclusion In this PS‐matched comparison between TMVR and M‐TEER in patients with severe SMR, TMVR was associated with superior reduction of MR and superior symptomatic improvement. While post‐procedural mortality tended to be higher after TMVR, no significant differences in mortality were found beyond 30 days.
    Type of Medium: Online Resource
    ISSN: 1388-9842 , 1879-0844
    URL: Issue
    URL: Article
    DOI: 10.1002/ejhf.v25.3
    DOI: 10.1002/ejhf.2797
    Language: English
    Publisher: Wiley
    Publication Date: 2023
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  • 3
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    A novel anatomic classification to guide transcatheter aortic valve replacement for pure aortic regurgitation
    Wiley ; 2022
    In:  Echocardiography Vol. 39, No. 12 ( 2022-12), p. 1571-1580
    Details
    In: Echocardiography, Wiley, Vol. 39, No. 12 ( 2022-12), p. 1571-1580
    Abstract: The success of transcatheter aortic valve replacement (TAVR) in native aortic regurgitation (AR) is limited by the absence of calcified anchoring structures. We sought to evaluate transfemoral TAVR in patients with native AR using a novel aortic root imaging classification. Methods From March to November 2021, 81 patients with severe AR were prospectively enrolled in 2 cardiac centers in China. All were evaluated using multidetector computed tomography (MDCT) and classified into 4 anatomic types in reference to transcatheter heart valve (THV) anchoring: Type 1: anchoring at the left ventricular outflow tract (LVOT), annulus, and ascending aorta (AA); Type 2: anchoring at the annulus and AA; Type 3: anchoring at the annulus and LVOT; and Type 4: anchoring at only 1 level or none at all. Based on the dual‐anchoring strategy, patients with Types 1–3 were considered TAVR candidates. Procedural and 30‐day outcomes were assessed according to Valve Academic Research Consortium‐3 definitions. Results TAVR was performed in 32 (39.5%) patients (71.9 ± 8.0 years of age, 71.9% were male) using 2 self‐expanding THVs. Types 1, 2, and 3 comprised 13 (40.6%), 11 (34.4%), and 8 (25.0%) cases, respectively. The procedural and device success rates were 100% and 93.8%, respectively, with 2 THV migration. Eight patients (25.0%) required a permanent pacemaker, and 2 (6.3%) developed moderate paravalvular leaks. No deaths or other major complications occurred during the study. Conclusions The novel anatomic classification and dual‐anchoring strategy were associated with a high procedural success rate with favorable short‐term safety and clinical outcomes.
    Type of Medium: Online Resource
    ISSN: 0742-2822 , 1540-8175
    URL: Issue
    URL: Article
    DOI: 10.1111/echo.v39.12
    DOI: 10.1111/echo.15490
    Language: English
    Publisher: Wiley
    Publication Date: 2022
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  • 4
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    The Influence of Cannulation Technique on Blood Flow to the Brain in Rats Undergoing Cardiopulmonary Bypass: A Cautionary “Tail” : THOUGHTS AND PROGRESS
    Wiley ; 2010
    In:  Artificial Organs Vol. 34, No. 6 ( 2010-05-07), p. 498-503
    Details
    In: Artificial Organs, Wiley, Vol. 34, No. 6 ( 2010-05-07), p. 498-503
    Type of Medium: Online Resource
    ISSN: 0160-564X , 1525-1594
    URL: Issue
    URL: Article
    DOI: 10.1111/aor.2010.34.issue-6
    DOI: 10.1111/j.1525-1594.2009.00917.x
    Language: English
    Publisher: Wiley
    Publication Date: 2010
    detail.hit.zdb_id: 2003825-2
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  • 5
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    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
    Wiley ; 2022
    In:  Catheterization and Cardiovascular Interventions Vol. 99, No. 1 ( 2022-01), p. 171-178
    Details
    In: Catheterization and Cardiovascular Interventions, Wiley, Vol. 99, No. 1 ( 2022-01), p. 171-178
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1522-1946 , 1522-726X
    URL: Issue
    URL: Article
    DOI: 10.1002/ccd.v99.1
    DOI: 10.1002/ccd.29889
    Language: English
    Publisher: Wiley
    Publication Date: 2022
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  • 6
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    First‐in‐man study of Heartech® percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction
    Wiley ; 2019
    In:  Catheterization and Cardiovascular Interventions Vol. 94, No. 6 ( 2019-11-15), p. 845-853
    Details
    In: Catheterization and Cardiovascular Interventions, Wiley, Vol. 94, No. 6 ( 2019-11-15), p. 845-853
    Abstract: This first‐in‐man (FIM) study aimed to determine the safety and efficacy of the Heartech® left ventricular partitioning device (LVPD) in patients with chronic heart failure (HF) postmyocardial infarction. Methods Sixteen patients were enrolled from three cardiac intervention centers in China. All patients underwent percutaneous ventricular restoration (PVR) procedures with implantation of the Heartech® LVPD. Safety and immediate success rates were recorded. Major adverse cardiovascular and cerebrovascular events (MACCEs) including all‐cause mortality, myocardial infarction, stroke, emergent or selective surgery or interventional therapy, renal failure requiring hemodialysis, and major bleeding were recorded. Efficacy features included functional status, echocardiographic characteristics, life quality characteristics including peak oxygen consumption of cardiopulmonary exercise testing (CPET), European five‐dimensional health scale (EQ‐5D), 6‐min walk test (6MWT) at baseline and during follow‐up (NCT 02938637). Results The device success rate was 93.75% (15 successes in 16 patients) with 100% safety. During follow‐up of 36 ± 4.5 days, no MACCEs were found. The left ventricular end‐systolic volume index decreased significantly (LVESVi, 72.47 ± 22.77 mL/m 2 vs. 50.13 ± 13.36 mL/m 2 , p   〈  .001) as did left ventricular end diastolic volume index (LVEDVi, 106.27 ± 28.01 mL/m 2 vs. 83.20 ± 16.87 mL/m 2 , p = .001). Left ventricular ejection fraction (LVEF, 32.47 ± 6.98% vs. 40.41 ± 6.15, p   〈  .001), 6MWT (383.13 ± 108.70 vs. 453.47 ± 88.24, p 〈  0.001) and EQ‐5D (65.93 ± 11.25 vs. 78.67 ± 8.35, p   〈  .001) improved significantly. Conclusions Heartech® LVPD appeared to be safe and effective for treatment of HF postmyocardial infarction.
    Type of Medium: Online Resource
    ISSN: 1522-1946 , 1522-726X
    URL: Issue
    URL: Article
    DOI: 10.1002/ccd.v94.6
    DOI: 10.1002/ccd.28366
    Language: English
    Publisher: Wiley
    Publication Date: 2019
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  • 7
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    Anatomic suitability for transapical transcatheter mitral valve implantation using a tether‐based device
    Wiley ; 2023
    In:  Catheterization and Cardiovascular Interventions Vol. 102, No. 2 ( 2023-08), p. 318-327
    Details
    In: Catheterization and Cardiovascular Interventions, Wiley, Vol. 102, No. 2 ( 2023-08), p. 318-327
    Abstract: Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models. Aims This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI. Methods Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end‐systole and end‐diastole, simulated device implantation, and neo‐left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process. Results Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT‐derived left ventricular end‐systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p   〈  0.0001). The mitral inter‐commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions 〈 30 or 〉 50 mm resulting in a negative predictive value of 94.4%. Conclusions MSCT‐derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether‐based TMVI device.
    Type of Medium: Online Resource
    ISSN: 1522-1946 , 1522-726X
    URL: Issue
    URL: Article
    DOI: 10.1002/ccd.v102.2
    DOI: 10.1002/ccd.30752
    Language: English
    Publisher: Wiley
    Publication Date: 2023
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  • 8
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    Transcatheter aortic valve implantation for paradoxical low‐flow low‐gradient aortic stenosis patients
    Wiley ; 2016
    In:  Catheterization and Cardiovascular Interventions Vol. 87, No. 4 ( 2016-03), p. 797-804
    Details
    In: Catheterization and Cardiovascular Interventions, Wiley, Vol. 87, No. 4 ( 2016-03), p. 797-804
    Abstract: We compared the outcomes of transcatheter aortic valve implantation (TAVI) in three different aortic stenosis syndromes: paradoxical low‐flow low‐gradient aortic stenosis (PLFLG), high‐gradient aortic stenosis (HGAS), and low ejection fraction low‐gradient severe aortic stenosis (LEF‐LG). Background Outcomes for PLFLG patients after TAVI procedure are not well known. Methods Between 2010 and 2013, patients with severe (indexed aortic valve area iAVA≤0.6 cm 2 /m 2 ) symptomatic aortic stenosis were consecutively referred to our institution for TAVI because of multiple comorbidities and excessive surgical risk. About 262 patients were split into three groups as following, PLFLG: mean gradient MG≤40 mm Hg, stroke volume index SVI≤35 mL/m 2 , ejection fraction EF≥55%, valvuloarterial impedance Zva 〉 4.5 mm Hg/mL/m 2 , maximal aortic jet velocity MaxV 〈 4 m/s; LEF‐LG: MG≤40 mm Hg, MaxV 〈 4 m/s, EF≤50%, SVI≤35 mL/m 2 ; and HGAS: MaxV 〉 4 m/s, MG 〉 40 mm Hg, EF 〉 55%. The primary endpoint of our study was to evaluate mid‐term global and cardiovascular mortalities; secondary endpoints included recommended VARC‐2 variables. Results PLFLG ( n  = 31) mid‐term survival was similar to HGAS ( n  = 172) (mean follow‐up = 13.2 months [4.6–26]). Conversely LEF‐LG patients ( n  = 59) displayed significant higher rates of all‐cause ( P  = 0.01) and cardiovascular mortalities ( P  = 0.05). Postprocedural outcomes (VARC‐2 criteria) were similar in the PLFLG and HGAS groups except regarding major bleeding ( P  = 0.02), while the LEF‐LG group had more congestive heart failure and a higher BNP before discharge (both P   〈  0.001) than the other groups. 30‐days deaths were significantly more frequent in LEF‐LG and PLFLG in comparison to HGAS ( P  = 0.03). Conclusion As opposed to LEF‐LG patients, mid‐term prognosis after TAVI procedure in PLFLG patients is similar to HGAS patients despite higher perioperative mortality. © 2015 Wiley Periodicals, Inc.
    Type of Medium: Online Resource
    ISSN: 1522-1946 , 1522-726X
    URL: Issue
    URL: Article
    DOI: 10.1002/ccd.v87.4
    DOI: 10.1002/ccd.26253
    Language: English
    Publisher: Wiley
    Publication Date: 2016
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  • 9
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    Transcatheter aortic valve implantation using the left transcarotid approach in patients with previous ipsilateral carotid endarterectomy
    Wiley ; 2015
    In:  Catheterization and Cardiovascular Interventions Vol. 85, No. 7 ( 2015-06)
    Details
    In: Catheterization and Cardiovascular Interventions, Wiley, Vol. 85, No. 7 ( 2015-06)
    Abstract: To assess the feasibility and safety of transcatheter aortic valve implantation (TAVI) through a left transcarotid approach in patients previously operated on for ipsilateral carotid endarterectomy (CEA). Background The healthcare impact of extracranial carotid artery disease is essential as stroke is the third‐leading cause of death in industrialized nations and CEA is often present in the history of patients awaiting TAVI. Methods The primary endpoint was to evaluate 30‐day mortality and freedom from major TAVI‐related complications in an observational analysis. Results From December 2011 to February 2014, we performed 9 TAVI. The mean age was 84.6 years. The procedure was performed without any technical complication or vascular injury in every patient. There was neither intraoperative mortality nor intraoperative major complications. One (11.1%) patient experienced spatial‐temporal disorientation but cerebral computed tomography did not show any sign of stroke. Two (22.2%) patients needed the implantation of a pacemaker due to third‐degree atrioventricular block appearance. Three (33.3%) patients were transfused with packed red blood cells and 1 (11.1%) patient developed a groin hematoma. Only 1 (11.1%) patient showed a residual paravalvular regurgitation ≥ 2. At 30‐day follow‐up there was neither mortality nor other TAVI‐related complications and echocardiography parameters remained stable. Conclusions TAVI through a left transcarotid approach in patients previously operated on for ipsilateral CEA is feasible and safe. The presence of a previous ipsilateral CEA represents no more a limitation to the utilization of this promising access route. At short‐term follow‐up, mortality and major complications rates are low. © 2014 Wiley Periodicals, Inc.
    Type of Medium: Online Resource
    ISSN: 1522-1946 , 1522-726X
    URL: Issue
    URL: Article
    DOI: 10.1002/ccd.v85.7
    DOI: 10.1002/ccd.25779
    Language: English
    Publisher: Wiley
    Publication Date: 2015
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  • 10
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    A dedicated Y‐shaped percutaneous ECMO cannula for femoral 2‐in‐1 vascular access during high‐risk procedures
    Wiley ; 2021
    In:  Catheterization and Cardiovascular Interventions Vol. 97, No. 5 ( 2021-04), p. 959-961
    Details
    In: Catheterization and Cardiovascular Interventions, Wiley, Vol. 97, No. 5 ( 2021-04), p. 959-961
    Abstract: High‐risk transcatheter procedures requiring hemodynamic support are growing and require multiple vascular access that may be challenging in cases of peripheral artery disease or lack of radial access and exposure to a higher risk of vascular complications. We report the novel utilization of a Y‐shaped arterial extracorporeal membrane oxygenation (ECMO) cannula used as a single femoral access to perform percutaneous coronary intervention (PCI) and aortography during high‐risk transcatheter aortic valve replacement (TAVR). The utilization of this 2‐in‐1 ECMO cannula may simplify vascular access and reduce vascular and bleeding complications during high‐risk ECMO‐supported transcatheter procedures.
    Type of Medium: Online Resource
    ISSN: 1522-1946 , 1522-726X
    URL: Issue
    URL: Article
    DOI: 10.1002/ccd.v97.5
    DOI: 10.1002/ccd.29299
    Language: English
    Publisher: Wiley
    Publication Date: 2021
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