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1.
Eur Heart J ; 45(21): 1904-1916, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38554125

ABSTRACT

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.


Subject(s)
Aortic Valve Stenosis , Benchmarking , Length of Stay , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/surgery , Male , Female , Aged, 80 and over , Length of Stay/statistics & numerical data , Aged , Critical Pathways , Europe/epidemiology , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Patient Safety
2.
Circ Cardiovasc Imaging ; 15(12): e014901, 2022 12.
Article in English | MEDLINE | ID: mdl-36538596

ABSTRACT

BACKGROUND: Use of the current echocardiography-based indications for aortic regurgitation (AR) surgery might result in late valve replacement at the stage of irreversible myocardial damage. Therefore, we aimed to identify simple models combining multiple echocardiography or magnetic resonance imaging (MRI)-derived indices and natriuretic peptides (BNP [brain natriuretic peptide] or NT-proBNP [N-terminnal pro-B type natriuretic peptide]) to predict early disease decompensation in asymptomatic severe AR. METHODS: This prospective and multicenter study included asymptomatic patients with severe AR, preserved left ventricular ejection fraction (>50%), and sinus rhythm. The echocardiography and MRI images were analyzed centrally in the CoreLab. The study end point was the onset of indication for aortic valve surgery as per current guidelines. RESULTS: The derivative cohort consisted of 127 asymptomatic patients (age 45±14 years, 84% males) with 41 (32%) end points during a median follow-up of 1375 (interquartile range, 1041-1783) days. In multivariable Cox regression analysis, age, BNP, 3-dimensional vena contracta area, MRI left ventricular end-diastolic volume index, regurgitant volume, and a fraction were identified as independent predictors of end point (all P<0.05). However, a combined model including one parameter of AR assessment (MRI regurgitant volume or regurgitant fraction or 3-dimensional vena contracta area), 1 parameter of left ventricular remodeling (MRI left ventricular end-diastolic volume index or echocardiography 2-dimensional global longitudinal strain or E wave), and BNP showed significantly higher predictive accuracy (area under the curve, 0.74-0.81) than any parameter alone (area under the curve, 0.61-0.72). These findings were confirmed in the validation cohort (n=100 patients, 38 end points). CONCLUSIONS: In asymptomatic severe AR, multimodality and multiparametric model combining 2 imaging indices with natriuretic peptides, showed high accuracy to identify early disease decompensation. Further prospective studies are warranted to explore the clinical benefit of implementing these models to guide patient management. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02910349.


Subject(s)
Aortic Valve Insufficiency , Male , Humans , Adult , Middle Aged , Female , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/surgery , Stroke Volume , Ventricular Function, Left , Echocardiography , Magnetic Resonance Imaging , Natriuretic Peptide, Brain
3.
Int J Artif Organs ; 44(11): 838-845, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34541968

ABSTRACT

INTRODUCTION: Inherited thrombophilias represent a concerning risk factor due to a proclivity to an aberrant clot formation. However, in patients with left ventricular assist device (LVAD), their impact on bleeding and thrombotic complications remains still poorly understood. The aim of the present study was to evaluate the effect of thrombophilic mutation directed anticoagulation therapy on adverse clinical outcomes in LVAD patients. MATERIALS AND METHODS: About 138 consecutive patients indicated for LVAD implant (HeartMate II, Abbott, Plymouth, USA) were prospectively screened for three major thrombophilic mutations: factor II (prothrombin), factor V Leiden, and homozygous methylenetetrahydrofolate reductase (MTHFR). Subsequently, discordant individualized anticoagulation targets of INR 2.5-3.0 in thrombophilia positive and INR 1.8-2.2 in negative patients were established; notably without anti-platelet agents given the center standard of care. RESULTS: Mean age was 50 ± 12.7 years, 83% male. Mean duration of support was 464.5 days (SD 482.9; SEM 41.1) and median of 310 days (IQR 162; 546). Full thrombophilia positive cohort analysis has not revealed any significant impact on event free survival. In contrast, detailed analysis of specific thrombophilias subsets has revealed Factor II prothrombin mutation as a significant predisposition for the pump thrombosis risk (SHR 10.48; p = 0.001) despite more aggressive prespecified anticoagulation target. Moreover, the incidence of bleeding events in prothrombin group was also significantly increased (SHR 6.0; p = 0.03). CONCLUSIONS: Our observations suggest that specific thrombophilias in LVAD patients may pose different intensity predisposition for thrombotic complications. Factor II (prothrombin) positive mutation was identified as significant risk factor associated with the pump thrombosis.


Subject(s)
Heart-Assist Devices , Thrombophilia , Thrombosis , Adult , Female , Heart-Assist Devices/adverse effects , Humans , Male , Middle Aged , Prospective Studies , Prothrombin , Thrombophilia/diagnosis , Thrombophilia/genetics , Thrombosis/genetics
4.
EuroIntervention ; 17(4): e274-e286, 2021 Jul 20.
Article in English | MEDLINE | ID: mdl-34057071

ABSTRACT

There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.


Subject(s)
Cardiovascular System , Heart-Assist Devices , Percutaneous Coronary Intervention , Consensus , Heart-Assist Devices/adverse effects , Humans , Percutaneous Coronary Intervention/adverse effects , Shock, Cardiogenic/therapy
5.
Eur Heart J Acute Cardiovasc Care ; 10(5): 570-583, 2021 Jun 30.
Article in English | MEDLINE | ID: mdl-34057173

ABSTRACT

There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.


Subject(s)
Heart-Assist Devices , Percutaneous Coronary Intervention , Consensus , Hemodynamics , Humans , Intra-Aortic Balloon Pumping , Shock, Cardiogenic/therapy
7.
Open Heart ; 8(1)2021 01.
Article in English | MEDLINE | ID: mdl-33419934

ABSTRACT

AIMS: There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). METHODS: Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age. RESULTS: Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001). CONCLUSIONS: The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.


Subject(s)
Aortic Valve Stenosis/epidemiology , Aortic Valve/surgery , Heart Valve Prosthesis , Registries , Risk Assessment/methods , Transcatheter Aortic Valve Replacement/methods , Age Factors , Aged , Aged, 80 and over , Aortic Valve Stenosis/surgery , Europe/epidemiology , Female , Follow-Up Studies , Humans , Incidence , Male , Retrospective Studies , Risk Factors , Severity of Illness Index , Sex Factors , Time Factors
8.
Open Heart ; 8(1)2021 01.
Article in English | MEDLINE | ID: mdl-33431618

ABSTRACT

OBJECTIVE: Approximately 3.4% of adults aged >75 years suffer from aortic stenosis (AS). Guideline indications for aortic valve replacement (AVR) distinguish between patients with symptomatic and asymptomatic severe AS. The present analysis aims to assess contemporary practice in the treatment of severe AS across Europe and identify characteristics associated with treatment decisions, namely denial of AVR in symptomatic patients and assignment of asymptomatic patients to AVR. METHODS: Participants of the prospective, multinational IMPULSE database of patients with severe AS were grouped according to AS symptoms, and stratified into subgroups based on assignment to/denial of AVR. RESULTS: Of 1608 symptomatic patients, 23.8% did not undergo AVR and underwent medical treatment. Denial was independently associated with multiple factors, including severe frailty (p=0.024); mitral (p=0.002) or tricuspid (p=0.004) regurgitation grade III/IV, and the presence of renal impairment (p=0.017). Of 392 asymptomatic patients, 86.5% had no prespecified indication for AVR. Regardless, 36.3% were assigned to valve replacement. Those with an indexed aortic valve area (AVA; p=0.045) or left ventricular ejection fraction (LVEF; p<0.001) below the study median; or with a left ventricular end systolic diameter above the study median (p=0.007) were more likely to be assigned to AVR. CONCLUSIONS: There may be considerable discrepancies between guideline-based recommendations and clinical practice decision-making in the treatment of AS. It appears that guidelines may not fully capture the complete clinical spectrum of patients with AS. Thus, there is a need to find ways to increase their acceptance and the rate of adoption.


Subject(s)
Aortic Valve Stenosis/surgery , Disease Management , Practice Guidelines as Topic , Quality of Health Care , Transcatheter Aortic Valve Replacement/standards , Aged , Aortic Valve Stenosis/diagnosis , Echocardiography , Female , Follow-Up Studies , Humans , Male , Prospective Studies , Severity of Illness Index
9.
Appl Radiat Isot ; 166: 109313, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32758707

ABSTRACT

There is a lack of reliable experiments aiming at the prompt fission neutron spectrum of 235U for energies higher than 10 MeV. The presented experiment performed at the LVR-15 light water reactor aimed at the measurement of very high threshold reactions spectral averaged cross sections such as 55Mn (n,2n)54Mn, 197Au (n,2n)196Au, 197Au (n,3n)195Au, 209Bi(n,3n)207Bi, 209Bi(n,4n)206Bi. 209Bi(n,3n)207Bi and 209Bi(n,4n)206Bi reactions were measured for the first time. 58Ni(n,p)58Co reaction was used as a monitor reaction. The experimental spectral averaged cross sections are derived from reaction rates measured by means of high purity Germanium spectroscopy at the well defined detector. The experimental spectral averaged cross sections are compared with calculations using either ENDF/B-VIII.0 or JEFF-3.3 235U prompt fission neutron spectrum and IRDFF-II cross sections. The discrepancy is higher with higher mean response energy for JEFF-3.3 unlike ENDF/B-VIII.0, where the agreement is good within broad range of mean response energy. Moreover, due to the high thermal neutron flux in the reactor, the experimental reaction rate is compared with calculated 198Au (n,g)199Au reaction rate. The difference of -55.3% for double capture reaction was found in comparison with ROSFOND-2010 calculations.

10.
Open Heart ; 7(2)2020 07.
Article in English | MEDLINE | ID: mdl-32709699

ABSTRACT

BACKGROUND: Contemporary data regarding the impact of comorbidities on the clinical presentation and management of patients with severe aortic stenosis (AS) are scarce. METHODS: Prospective registry of severe patients with AS across 23 centres in nine European countries. RESULTS: Of the 2171 patients, chronic kidney disease (CKD 27.3%), left ventricular ejection fraction (LVEF) <50% (22.0%), atrial fibrillation (15.9%) and chronic obstructive pulmonary disease (11.4%) were the most prevalent comorbidities (49.3% none, 33.9% one and 16.8% ≥2 of these). The decision to perform aortic valve replacement (AVR) was taken in a comparable proportion (67%, 72% and 69%, in patients with 0, 1 and ≥2 comorbidities; p=0.186). However, the decision for TAVI was more common with more comorbidities (35.4%, 54.0% and 57.0% for no, 1 and ≥2; p<0.001), while the decision for surgical AVR (SAVR) was decreased with increasing comorbidity burden (31.9%, 17.4% and 12.3%; p<0.001). The proportion of patients with planned AVRs that were performed within 3 months was significantly higher in patients with 1 or ≥2 comorbidities than in those without (8.7%, 10.0% and 15.7%; p<0.001). Furthermore, the mean time to AVR was significantly shorter in patients with one (30.5 days) or ≥2 comorbidities (30.8 days) than in those without (35.7 days; p=0.012). Patients with reduced LVEF tended to be offered an AVR more frequently and with a shorter delay while patients with CKD were less frequently treated. CONCLUSIONS: Comorbidities in severe patients with AS affect the presentation and management of patients with severe AS. TAVI was offered more often than SAVR and performed within a shorter time period.


Subject(s)
Aortic Valve Stenosis/epidemiology , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/trends , Time-to-Treatment/trends , Transcatheter Aortic Valve Replacement/trends , Aged , Aged, 80 and over , Aortic Valve Stenosis/physiopathology , Atrial Fibrillation/epidemiology , Clinical Decision-Making , Comorbidity , Europe/epidemiology , Female , Humans , Male , Prevalence , Prospective Studies , Pulmonary Disease, Chronic Obstructive/epidemiology , Registries , Renal Insufficiency, Chronic/epidemiology , Risk Assessment , Risk Factors , Severity of Illness Index , Stroke Volume , Time Factors , Treatment Outcome , Ventricular Function, Left
11.
ESC Heart Fail ; 7(4): 1976-1981, 2020 08.
Article in English | MEDLINE | ID: mdl-32485066

ABSTRACT

A 19-year-old woman with no previous cardiac history was admitted to the hospital with third-degree atrioventricular block and left ventricular dysfunction. Her condition quickly deteriorated to severe biventricular failure and cardiogenic shock requiring mechanical circulatory support. An endomyocardial biopsy revealed lymphocytic myocarditis with no PCR-detectable viral genomes, with CD8 T-cell predominance and pro-inflammatory macrophage expansion shown by myocardial flow cytometry. The therapy consisted of immunosuppression (high-dose methylprednisolone) and temporary mechanical circulatory support with enhanced ability to achieve left ventricular unloading by combination of extracorporeal membrane oxygenation with Impella (ECMELLA). After 2 weeks of support, complete and sustained recovery from myocarditis was observed.


Subject(s)
Heart-Assist Devices , Myocarditis , Adult , CD8-Positive T-Lymphocytes , Female , Humans , Immunosuppression Therapy , Myocarditis/diagnosis , Myocarditis/etiology , Myocarditis/therapy , Treatment Outcome , Young Adult
12.
Eur Heart J ; 41(12): 1286-1297, 2020 03 21.
Article in English | MEDLINE | ID: mdl-31435675

ABSTRACT

Ventricular pressure-volume (PV) analysis is the reference method for the study of cardiac mechanics. Advances in calibration algorithms and measuring techniques brought new perspectives for its application in different research and clinical settings. Simultaneous PV measurement in the heart chambers offers unique insights into mechanical cardiac efficiency. Beat to beat invasive PV monitoring can be instrumental in the understanding and management of heart failure, valvular heart disease, and mechanical cardiac support. This review focuses on intra cardiac left ventricular PV analysis principles, interpretation of signals, and potential clinical applications.


Subject(s)
Heart Failure , Heart Ventricles , Cardiac Volume , Heart , Heart Ventricles/diagnostic imaging , Humans , Myocardial Contraction , Stroke Volume , Ventricular Function, Left , Ventricular Pressure
13.
J Clin Med ; 8(10)2019 Oct 11.
Article in English | MEDLINE | ID: mdl-31614523

ABSTRACT

Background: Determining the value of new imaging markers to predict aortic valve (AV) surgery in asymptomatic patients with severe aortic regurgitation (AR) in a prospective, observational, multicenter study. Methods: Consecutive patients with chronic severe AR were enrolled between 2015-2018. Baseline examination included echocardiography (ECHO) with 2- and 3-dimensional (2D and 3D) vena contracta area (VCA), and magnetic resonance imaging (MRI) with regurgitant volume (RV) and fraction (RF) analyzed in CoreLab. Results: The mean follow-up was 587 days (interquartile range (IQR) 296-901) in a total of 104 patients. Twenty patients underwent AV surgery. Baseline clinical and laboratory data did not differ between surgically and medically treated patients. Surgically treated patients had larger left ventricular (LV) dimension, end-diastolic volume (all p < 0.05), and the LV ejection fraction was similar. The surgical group showed higher prevalence of severe AR (70% vs. 40%, p = 0.02). Out of all imaging markers 3D VCA, MRI-derived RV and RF were identified as the strongest independent predictors of AV surgery (all p < 0.001). Conclusions: Parameters related to LV morphology and function showed moderate accuracy to identify patients in need of early AV surgery at the early stage of the disease. 3D ECHO-derived VCA and MRI-derived RV and RF showed high accuracy and excellent sensitivity to identify patients in need of early surgery.

14.
J Am Heart Assoc ; 8(19): e013160, 2019 10.
Article in English | MEDLINE | ID: mdl-31549578

ABSTRACT

Background Many patients with severe aortic stenosis are referred late with advanced symptoms or inappropriately denied intervention. The objective was to investigate whether a structured communication to referring physicians (facilitated data relay) might improve the rate and timeliness of intervention. Methods and Results A prospective registry of consecutive patients with severe aortic stenosis at 23 centers in 9 European countries with transcatheter as well as surgical aortic valve replacement being available was performed. The study included a 3-month documentation of the status quo (phase A), a 6-month intervention phase (implementing facilitated data relay), and a 3-month documentation of a legacy effect (phase-B). Two thousand one hundred seventy-one patients with severe aortic stenoses were enrolled (phase A: 759; intervention: 905; phase-B: 507). Mean age was 77.9±10.0 years, and 80% were symptomatic, including 52% with severe symptoms. During phase A, intervention was planned in 464/696 (67%), 138 (20%) were assigned to watchful waiting, 8 (1%) to balloon aortic valvuloplasty, 60 (9%) were listed as not for active treatment, and in 26 (4%), no decision was made. Three hundred sixty-three of 464 (78%) patients received the planned intervention within 3 months. Timeliness of the intervention improved as shown by the higher number of aortic valve replacements performed within 3 months (59% versus 51%, P=0.002) and a significant decrease in the time to intervention (36±38 versus 30±33 days, P=0.002). Conclusions A simple, low-cost, facilitated data relay improves timeliness of treatment for patients diagnosed with severe aortic stenosis, resulting in a shorter time to transcatheter aortic valve replacement. This effect was mainly driven by a significant improvement in timeliness of intervention in transcatheter aortic valve replacement but not surgical aortic valve replacement. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02241447.


Subject(s)
Aortic Valve Stenosis/therapy , Balloon Valvuloplasty , Heart Valve Prosthesis Implantation , Nurse's Role , Referral and Consultation , Time-to-Treatment , Transcatheter Aortic Valve Replacement , Watchful Waiting , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/nursing , Balloon Valvuloplasty/adverse effects , Clinical Decision-Making , Cross-Sectional Studies , Echocardiography , Eligibility Determination , Europe , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Patient Selection , Prospective Studies , Registries , Severity of Illness Index , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
15.
Heart ; 105(22): 1709-1716, 2019 11.
Article in English | MEDLINE | ID: mdl-31302639

ABSTRACT

OBJECTIVE: Contemporary data on patients with previously undiagnosed severe aortic stenosis (AS) are scarce. We aimed to address this gap by gathering data from consecutive patients diagnosed with severe AS on echocardiography. METHODS: This was a prospective, multicentre, multinational, registry in 23 tertiary care hospitals across 9 European countries. Patients with a diagnosis of severe AS were included using echocardiography (aortic valve area (AVA) <1 cm2, indexed AVA <0.6 cm2/m2, maximum jet-velocity (Vmax) >4 m/s and/or mean transvalvular gradient >40 mm Hg). RESULTS: The 2171 participants had a mean age of 77.9 years and 48.0% were female. The mean AVA was 0.73 cm2, Vmax4.3 m/s and mean gradient 47.1 mm Hg; 62.1% had left ventricular hypertrophy and 27.3% an ejection fraction (EF) <50%. 1743 patients (80.3%) were symptomatic (shortness-of-breath 91.0%; dizziness 30.2%, chest pain 28.9%). Patients had a EuroSCORE II of 4.0; 25.3% had a creatinine clearance <50 mL/min, and 3.2% had an EF <30%. Symptomatic patients were older and had more comorbidities than asymptomatic patients. Despite European Society of Cardiology 2017 valvular heart disease guideline class I recommendation, in only 76.2% a decision was made for an intervention (transcatheter 50.4%, surgical aortic valve replacement 25.8%). In asymptomatic patients, 57.7% with a class I/IIa indication were scheduled for a procedure, while 36.3% patients without an indication had their valve replaced. CONCLUSIONS: The majority of patients with severe AS presented at an advanced disease stage. Management of severe AS remained suboptimal in a significant proportion of contemporary patients with severe AS. TRIAL REGISTRATION NUMBER: NCT02241447;Results.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/therapy , Aortic Valve/diagnostic imaging , Echocardiography , Age Factors , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Stenosis/physiopathology , Asymptomatic Diseases , Comorbidity , Cross-Sectional Studies , Europe , Female , Hemodynamics , Humans , Male , Predictive Value of Tests , Prognosis , Prospective Studies , Registries , Risk Assessment , Risk Factors , Severity of Illness Index , Ventricular Function, Left
16.
Int J Cardiol ; 291: 96-104, 2019 09 15.
Article in English | MEDLINE | ID: mdl-31155332

ABSTRACT

For patients with myocardial infarct-related cardiogenic shock (CS), urgent percutaneous coronary intervention is the recommended treatment strategy to limit cardiac and systemic ischemia. However, a specific therapeutic intervention is often missing in non-ischemic CS cases. Though drug treatment with inotropes and/or vasopressors may be required to stabilize the patient initially, their ongoing use is associated with excess mortality. Coronary intervention in unstable patients often leads to further hemodynamic compromise either during or shortly after revascularization. Support devices like the intra-aortic balloon pump failed to improve clinical outcomes in infarct-related CS. Currently, more powerful and active hemodynamic support devices unloading the left ventricle such as transvalvular microaxial pumps are available and are being increasingly used. However, as for other devices large randomized trials are not yet available, and device use is based on registry data and expert consensus. In this article, a multidisciplinary group of experienced users of transvalvular microaxial pumps outlines the pathophysiological background on hemodynamic changes in CS, the available mechanical support devices, and current guideline recommendations. Furthermore, different hemodynamic situations in several case-based scenarios are used to illustrate candidate settings and to provide the theoretic and scientific rationale for left-ventricular unloading in these scenarios. Finally, organization of shock networks, monitoring, weaning, and typical complications and their prevention are discussed.


Subject(s)
Heart Failure/epidemiology , Heart Failure/therapy , Heart-Assist Devices/trends , Shock, Cardiogenic/epidemiology , Shock, Cardiogenic/therapy , Europe/epidemiology , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/trends , Heart Failure/diagnosis , Hemodynamics/physiology , Humans , Intra-Aortic Balloon Pumping/methods , Intra-Aortic Balloon Pumping/trends , Shock, Cardiogenic/diagnosis
17.
J Heart Lung Transplant ; 38(4): 339-343, 2019 04.
Article in English | MEDLINE | ID: mdl-30945635

ABSTRACT

The drive-line to power contemporary ventricular assist devices exiting the skin is associated with infection, and requires a holstered performance of the cardiac pump, which reduces overall quality of life. Attempts to eliminate the drive-line using transcutaneous energy transfer systems have been explored but have not succeeded in viable widespread application. The unique engineering of the coplanar energy transfer system is characterized by 2 large rings utilizing a coil-within-the-coil topology, ensuring robust resonance energy transfer while allowing for a substantial (>6 hours) unholstered circulatory support powered by an implantable battery source. Herein we report the first known human experience with this novel technology, coupled with a continuous-flow assist left ventricular assist device, in 2 consecutive patients evaluated with the primary end-point of system performance at 30 days post-implantation.


Subject(s)
Energy Transfer , Heart Failure/surgery , Heart-Assist Devices , Prosthesis Design , Wireless Technology , Female , Humans , Male , Middle Aged , Young Adult
18.
J Card Fail ; 25(1): 36-43, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30472281

ABSTRACT

BACKGROUND: The Heartmate 3 (HM3) is a Conformiteé Européenne mark-approved left ventricular (LV) assist device (LVAD) with fully magnetically levitated rotor and features consisting of a wide range operational speeds, wide flow paths, and artificial pulse. We performed a hemodynamic-echocardiographic speed optimization evaluation in HM3-implanted patients to achieve optimal LV- and right ventricular (RV) shape. METHODS AND RESULTS: Sixteen HM3 patients underwent pump speed ramp tests with right heart catheterization. Three-dimensional echocardiographic (3DE) LV and RV datasets (Philips) were acquired, and volumetric (Tomtec) and shape (custom software) analyses were performed (LV: sphericity, conicity; RV: septal and free-wall curvatures). Data were recorded at up to 13 speed settings. Speed changes were in 100-rpm steps, starting at 4600 rpm and ramping up to 6200 rpm. 3DE was feasible in 50% of the patients. Mean original speed was 5306 ± 148 rpm. LV end-diastolic (ED) diameter (-0.15 ± 0.09 cm/100 rpm) and volumes (ED: 269 ± 109 mL to 175 ± 90 mL; end-systolic [ES]: 234 ± 111 mL to 146 ± 81 mL) progressively decreased as the shape became less spherical and more conical; RV volumes initially remained stable, but at higher speeds increased (ED: from 148 ± 64 mL to 181 ± 92 mL; ES: 113 ± 63 mL to 130 ± 69 mL). On average, the RV septum became less convex (bulging toward the LV) at the highest speeds. CONCLUSIONS: LV and RV shape changes were noted in HM3-supported patients. Although a LV volumetric decrease and shape improvement was consistently noted, RV volumes grew in response to increase in speed above a certain point. A next concern would be whether understanding of morphologic and function changes in LV and RV during LVAD speed change assessed with the use of 3DE helps to optimize LVAD speed settings and improve clinical outcomes.


Subject(s)
Echocardiography, Three-Dimensional/trends , Heart Failure/diagnostic imaging , Heart Failure/therapy , Heart Ventricles/diagnostic imaging , Heart-Assist Devices/trends , Magnetic Field Therapy/trends , Aged , Cardiac Catheterization/methods , Cardiac Catheterization/trends , Female , Heart Ventricles/surgery , Humans , Magnetic Field Therapy/methods , Male , Middle Aged , Prospective Studies
19.
Biosci Rep ; 38(3)2018 06 29.
Article in English | MEDLINE | ID: mdl-29743195

ABSTRACT

Cardiac atrophy is the most common complication of prolonged application of the left ventricle (LV) assist device (LVAD) in patients with advanced heart failure (HF). Our aim was to evaluate the course of unloading-induced cardiac atrophy in rats with failing hearts, and to examine if increased isovolumic loading obtained by intraventricular implantation of an especially designed spring expander would attenuate this process. Heterotopic abdominal heart transplantation (HTx) was used as a rat model of heart unloading. HF was induced by volume overload achieved by creation of the aorto-caval fistula (ACF). The degree of cardiac atrophy was assessed as the weight ratio of the heterotopically transplanted heart (HW) to the control heart. Isovolumic loading was increased by intraventricular implantation of a stainless steel three-branch spring expander. The course of cardiac atrophy was evaluated on days 7, 14, 21, and 28 after HTx Seven days unloading by HTx in failing hearts sufficed to substantially decrease the HW (-59 ± 3%), the decrease progressed when measured on days 14, 21, and 28 after HTx Implantation of the spring expander significantly reduced the decreases in whole HW at all the time points (-39 ± 3 compared with -59 ± 3, -52 ± 2 compared with -69 ± 3, -51 ± 2 compared with -71 ± 2, and -44 ± 2 compared with -71 ± 3%, respectively; P<0.05 in each case). We conclude that the enhanced isovolumic heart loading obtained by implantation of the spring expander attenuates the development of unloading-induced cardiac atrophy in the failing rat heart.


Subject(s)
Atrophy/prevention & control , Heart Failure/surgery , Heart Transplantation , Heart Ventricles/surgery , Tissue Expansion Devices , Animals , Aorta/surgery , Atrial Natriuretic Factor/genetics , Atrial Natriuretic Factor/metabolism , Atrophy/metabolism , Atrophy/physiopathology , Atrophy/surgery , Biomarkers/metabolism , Disease Models, Animal , Equipment Design , Fibroblast Growth Factor 2/genetics , Fibroblast Growth Factor 2/metabolism , Fistula , Gene Expression , Glucose Transporter Type 1/genetics , Glucose Transporter Type 1/metabolism , Heart/physiopathology , Heart Failure/metabolism , Heart Failure/physiopathology , Heart Failure/therapy , Heart Ventricles/physiopathology , Humans , Implants, Experimental , Male , Rats , Rats, Inbred Lew , Sarcoplasmic Reticulum Calcium-Transporting ATPases/genetics , Sarcoplasmic Reticulum Calcium-Transporting ATPases/metabolism , Transplantation, Heterotopic , Vena Cava, Superior/surgery
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