362 research outputs found

    Transcatheter aortic valve implantation and bleeding: incidence, predictors and prognosis

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    Peri-procedural bleeding complications are feared adverse events in patients undergoing transcatheter aortic valve implantation (TAVI). Little is known about the implications of peri-procedural bleeding on clinical outcome. In a prospective single-center registry of consecutive patients undergoing TAVI, we investigated incidence, predictors and clinical consequences of life-threatening and major bleeding as defined by the Valve Academic Research Consortium. Among 389 consecutive patients undergoing TAVI by a transfemoral (79.2%), transapical (19.6%) or trans-subclavian (1.3%) approach between July 2007 and October 2011, life-threatening or major peri-procedural bleeding events occurred in 64 (16.4%) and 125 patients (32.1%), respectively. Patients with peri-procedural bleeding events had a higher logistic EuroSCORE, more advanced renal disease, and were more symptomatic as assessed by New York Heart Association functional class at baseline as compared to patients with no bleeding. Life-threatening bleeding was associated with a higher all-cause (17.2 vs 5.6 vs 3.0%, p<0.001) and cardiovascular mortality (10.9 vs 5.6 vs 2.5%, p=0.02) at 30days compared to patients with major bleeding or no bleeding. Multivariate analysis identified transapical access (OR 2.6, 95% CI 1.4-4.8; p=0.002), glomerular filtration rate <30ml/min (OR 2.3, 95% CI 1.1-4.7, p=0.031), and diabetes (OR 1.8, 95% CI 1.001-3.2, p=0.049) as independent predictors of life-threatening, peri-procedural bleeding. Life-threatening bleeding complications in patients undergoing TAVI are associated with increased mortality. Renal impairment, diabetes, and transapical approach were identified as independent risk factors for life-threatening bleeding event

    Valve-in-valve TAVI and risk of coronary obstruction: Validation of the VIVID classification.

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    BACKGROUND The Valve-in-Valve International Data (VIVID) registry proposed a simplified classification to assess the risk of coronary obstruction during valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) based on preprocedural multi-detector computed tomography (MDCT). We investigated the validity of the VIVID classification in patients undergoing ViV-TAVI for degenerated bioprostheses. METHODS Patients undergoing ViV-TAVI for degenerated bioprostheses were prospectively included in this study. The risk of coronary obstruction among patients treated with stented valves was retrospectively evaluated based on anatomical assessment on pre-procedural MDCT. RESULTS Among a total of 137 patients that underwent ViV-TAVI between August 2007 and June 2021, 109 patients had stented, sutureless, or transcatheter degenerated bioprosthesis of which 96 (88%) had adequate MDCT data for risk assessment. High-risk anatomy for coronary obstruction (VIVID type IIB, IIIB, or IIIC) in either the left or right coronary artery was observed in 30 patients (31.3%). Of the 30 patients with high-risk anatomy, coronary protection using wire protection or BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) was performed in 3 patients (10.0%). Three patients treated with stentless valves and one patient treated with a stented valve with externally mounted leaflets had coronary obstruction. None of the patients with high risk anatomy according to MDCT had coronary obstruction even without coronary protection. CONCLUSIONS Coronary obstruction occurred in none of the patients classified as high-risk patients according to the VIVID classification despite the absence of coronary protection. Refined tools are required to assess the risk of coronary obstruction. CLINICAL TRIAL REGISTRATION https://www. CLINICALTRIALS gov. NCT01368250

    Quality of life in high-risk patients: comparison of transcatheter aortic valve implantation with surgical aortic valve replacement†

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    OBJECTIVES To compare health-related quality of life (QoL) in patients undergoing transcatheter aortic valve implantation via transapical access (TA TAVI) with patients undergoing surgical aortic valve replacement (SAVR). METHODS One hundred and forty-four high-risk patients referred for aortic valve replacement underwent TAVI screening and were assigned to either TA TAVI (n=51, age 79.7±9.2 years, logistic EuroSCORE 26.5±16.1%, 51% males) or SAVR (n=93, age 81.1±5.3 years, logistic EuroSCORE 12.1±9.3%, 42% males) by the interdisciplinary heart team. QoL was assessed using the Short Form 36 (SF-36) Health Survey Questionnaire and the Hospital Anxiety and Depression Scale. Furthermore, current living conditions and the degree of independence at home were evaluated. RESULTS Patients undergoing TA TAVI were at higher risk as assessed by EuroSCORE (26.5±16 vs. 12.1±9, P<0.001) and STS score (6.7±4 vs. 4.4±3, P<0.001) compared with SAVR patients. At the 30-day follow-up, the rate of mortality was similar and amounted to 7.8% for TA TAVI and 7.5% for SAVR patients and raised to 25.5% in TA TAVI and 18.3% in SAVR patients after a follow-up period of 15±10 months. Assessment of QoL revealed no differences in terms of anxiety and depression between TA TAVI and SAVR patients. The SF-36 mental health metascore was similar in both groups (65.6±19 vs. 68.8±22, P=0.29), while a significant difference was observed in the physical health metascore (49.7±21 vs. 62.0±21, P=0.015). After adjustment for baseline characteristics, this difference disappeared. However, every added point in the preoperative risk assessment with the STS score decreased the SF-36 physical health dimension by two raw points at the follow-up assessment. CONCLUSIONS Selected high-risk patients undergoing TAVI by using a transapical access achieve similar clinical outcomes and QoL compared with patients undergoing SAVR. Increased STS scores predict worse QoL outcome

    Transcranial Doppler-detected cerebral embolic load during transcatheter aortic valve implantation†

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    OBJECTIVES Transcatheter aortic valve implantation (TAVI) is an alternative to surgery for high-risk patients with severe aortic valve stenosis. Periprocedural stroke is reported at an incidence up to 10%. Magnetic resonance imaging studies have identified new onset of clinically silent ischaemic cerebral lesions more frequently (68-84%). So far, few data are available about cerebral embolism during TAVI. The aim of this study was to determine the frequency of high-intensity transient signals (HITS) and to explore differences in the HITS pattern between transfemoral and transapical access and between self-expanding (SE) and balloon-expandable (BE) deployment technique. METHODS Transcranial Doppler (TCD) ultrasound recordings of 44 patients undergoing TAVI (age 78±6 years; logistic EuroSCORE 28±15%; transfemoral access, n=32; transapical access, n=12; SE, n=27; BE, n=17) were analysed for HITS during the following intervals: (i) instrumentation prior to valvuloplasty, (ii) balloon valvuloplasty, (iii) prosthesis deployment (DP) and (iv) post-implantation (PI) including any re-dilatation episodes. The total procedural load of HITS and HITS frequency in procedural intervals were compared between different access routes and DP techniques. Periprocedural neurocognitive impairment was assessed clinically and by the confusion assessment method (CAM) prior to TAVI and on post-procedural days 1 and 4-6. RESULTS TCD recordings demonstrated the occurrence of HITS in all patients. DP was associated with the highest load of HITS. Access route did not significantly influence the total burden of periprocedural HITS. During procedures using the SE type, a slightly larger total load of HITS was observed than with the BE type (P=0.024). This was mainly due to more HITS during the DP (P=0.027) and the PI interval (P=0.002). No incidence of delirium was detected by CAM ratings. Two patients suffered a new onset of stroke within the 2 weeks following the procedure. In-hospital death and 30-day mortality were 0/44. CONCLUSIONS HITS are observed during all procedural intervals in TAVI. The embolic events appear to peak during DP. In our series, the overall cerebral embolic load did not differ between the transfemoral and the transapical access route. TCD monitoring in TAVI is useful to identify periods and manipulations associated with an increased cerebral embolic load and may help to further enhance the safety of this procedur

    Mortality, Stroke, and Hospitalization Associated With Deferred vs Expedited Aortic Valve Replacement in Patients Referred for Symptomatic Severe Aortic Stenosis During the COVID-19 Pandemic.

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    This cohort study evaluates the outcomes associated with deferred vs expedited aortic valve replacement in patients with severe aortic stenosis during the COVID-19 pandemic

    SGLT2 inhibitor therapy for transthyretin amyloid cardiomyopathy: early tolerance and clinical response to dapagliflozin.

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    AIMS Sodium-glucose cotransporter 2 inhibitors (SGLT2i) improve clinical outcomes in heart failure patients with reduced and preserved left ventricular ejection fraction (LVEF), but have not yet been investigated in transthyretin amyloid cardiomyopathy (ATTR-CM). This study aimed to evaluate tolerability, clinical outcomes, and changes in NT-proBNP levels and glomerular filtration rate (GFR) in ATTR-CM patients treated with dapagliflozin. METHODS AND RESULTS Patients with stable, tafamidis-treated ATTR-CM were retrospectively evaluated at the initiation of dapagliflozin and 3 months thereafter. Tafamidis-treated ATTR-CM patients without SGLT2i served as a reference cohort. Overall, SLGT2i therapy was initiated in 34 patients. Seventeen patients with stable disease on tafamidis, who were subsequently started on dapagliflozin, were included in the analysis. Patients selected for SGLT2i presented with signs of advanced disease, evidenced by higher Gillmore disease stage (stage ≥2: 53% vs. 27.5%; P = 0.041), baseline median NT-proBNP [median (IQR) 2668 pg/mL (1314-3451) vs. 1424 (810-2059); P = 0.038] and loop diuretic demand (76.5% vs. 45% of patients; P = 0.044), and lower LVEF (46.6 ± 12.9 vs. 53.7 ± 8.7%; P = 0.019) and GFR (51.8 ± 16.5 vs. 68.5 ± 18.6 mL/min; P = 0.037) compared with the reference cohort. At 3-month follow-up, a numerical decrease in NT-proBNP levels was observed in 13/17 (76.5%) patients in the dapagliflozin (-190 pg/mL, IQR: -1,028-71, P = 0.557) and 27/40 (67.5%) of patients in the control cohort (-115 pg/mL, IQR: -357-105, P = 0.551). Other disease parameters remained stable and no adverse events occurred. CONCLUSIONS In tafamidis-treated ATTR-CM patients, initiation of dapagliflozin was well tolerated. The efficacy of SGLT2i therapy in patients with ATTR-CM needs to be studied in randomized controlled trials

    Impact of first-phase ejection fraction on clinical outcomes in patients undergoing transcatheter aortic valve implantation.

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    BACKGROUND First-phase left ventricular ejection fraction (LVEF1) is an early marker of left ventricular remodeling. Reduced LVEF1 has been associated with adverse prognosis in patients with aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF). It remains to be determined, whether reduced LVEF1 differentiates clinical outcomes after aortic valve replacement. OBJECTIVES We investigated the impact of LVEF1 on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) for symptomatic severe AS with preserved LVEF (≥ 50%). METHODS In the prospective Bern TAVI registry, we retrospectively categorized patients according to LVEF1 as assessed by transthoracic echocardiography. Clinical outcomes of interest were all-cause mortality and residual heart failure symptoms (New York Heart Association (NYHA) functional class III or IV) at 1 year after TAVI. RESULTS A total of 644 patients undergoing TAVI between January 2014 and December 2019 were included in the present analysis. Patients with low LVEF1 had a lower LVEF (62.0 ± 6.89% vs. 64.3 ± 7.82%, P < 0.001) and a higher left ventricular mass index (129.3 ± 39.1 g/m2 vs. 121.5 ± 38.0 g/m2; P = 0.027) compared to patients with high LVEF1. At 1 year, the incidence of all-cause/cardiovascular death, and NYHA III or IV were comparable between patients with low and high LVEF1 (8.3% vs. 9.2%; P = 0.773, 3.9% vs. 6.0%; P = 0.276, 12.9% vs. 12.2%; P = 0.892, respectively). CONCLUSIONS Reduced LVEF1 was not associated with adverse clinical outcomes following TAVI in patients with symptomatic severe AS with preserved LVEF. CLINICAL TRIAL REGISTRATION https://www. CLINICALTRIALS gov. NCT01368250

    Preinterventional screening of the TAVI patient: how to choose the suitable patient and the best procedure

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    Transcatheter aortic valve implantation (TAVI) is a novel therapy, which has transformed the management of inoperable patients presenting with symptomatic severe aortic stenosis (AS). It is also a proven and less invasive alternative therapeutic option for high-risk symptomatic patients presenting with severe AS who are otherwise eligible for surgical aortic valve replacement. Patient age is not strictly a limitation for TAVI but since this procedure is currently restricted to high-risk and inoperable patients, it follows that most patients selected for TAVI are at an advanced age. Patient frailty and co-morbidities need to be assessed and a clinical judgment made on whether the patient will gain a measureable improvement in their quality of life. Risk stratification has assumed a central role in selecting suitable patients and surgical risk algorithms have proven helpful in this regard. However, limitations exist with these risk models, which must be understood in the context of TAVI. When making final treatment decisions, it is essential that a collaborative multidisciplinary "heart team” be involved and this is stressed in the most recent guidelines of the European Society of Cardiology. Choosing the best procedure is contingent upon anatomical feasibility, and multimodality imaging has emerged as an integral component of the pre-interventional screening process in this regard. The transfemoral route is now considered the default approach although vascular complications remain a concern. A minimal vessel diameter of 6mm is required for currently commercial available vascular introducer sheaths. Several alternative access routes are available to choose from when confronted with difficult iliofemoral anatomy such as severe peripheral vascular disease or diffuse circumferential vessel calcification. The degree of aortic valve leaflet and annular calcification also needs to be assessed as the latter is a risk factor for post-procedural paravalvular aortic regurgitation. The ultimate goal of patient selection is to achieve the highest procedural success rate while minimizing complications and to choose patients most likely to derive tangible benefit from this procedure
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