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1.
Expert Rev Med Devices ; : 1-14, 2019 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-31594416

RESUMO

Introduction: Coronary chronic total occlusions (CTO) represent a challenging subset in interventional cardiology. Areas covered: During the last decade, improvements in materials, techniques, and meticulous pre-procedural lesion assessment have increased the success rate in CTO lesions. Several scores have been developed to address overall lesion evaluation and help select the most appropriate treatment strategy. In addition, specific algorithms such as the hybrid algorithm have been introduced to provide a framework for CTO operators and a rapid management of the various challenging aspects of the procedure. The hybrid approach requires operator's ability to switch from one treatment strategy to another when the first one appears to be unsuccessful. Adequate training and operators' experience remain crucial to improve the likelihood of success. Expert opinion: The aim of this review is to provide insights and guidance for operators on current approaches for treatment of CTO and complication management.

2.
Nat Rev Cardiol ; 2019 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-31527743

RESUMO

Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of symptomatic severe aortic valve stenosis. Current guidelines recommend TAVI in patients at increased operative risk of death. Advanced imaging planning, new transcatheter valve platforms, procedure streamlining and growing operator experience have improved procedural safety and bioprosthetic valve performance. As a result, TAVI has been explored for other indications. Two randomized trials published in 2019 to assess TAVI in patients with symptomatic severe aortic stenosis at low operative risk have set the stage for a new wave of indications. In younger and low-risk patients, TAVI had an early safety benefit over surgical aortic valve replacement and was associated with faster discharge from hospital and recovery and fewer rehospitalizations. In patients with symptomatic severe aortic stenosis, TAVI has now been explored across the entire spectrum of operative risk, from inoperable to low-risk populations, in properly designed, randomized clinical trials, although data on the long-term durability of these valves are lacking. The use of TAVI in severe bicuspid aortic valve stenosis, asymptomatic severe aortic stenosis, moderate aortic stenosis in combination with heart failure with reduced ejection fraction, and isolated pure aortic regurgitation is now under investigation in clinical trials. In this Review, we provide our perspective on these evolving indications for TAVI, discuss relevant available data from clinical trials, and highlight procedural implications and caveats of new and future indications.

3.
Eur Heart J ; 2019 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-31511897

RESUMO

Tricuspid regurgitation (TR) is a frequent and complex problem, commonly combined with left-sided heart disease, such as mitral regurgitation. Significant TR is associated with increased mortality if left untreated or recurrent after therapy. Tricuspid regurgitation was historically often disregarded and remained undertreated. Surgery is currently the only Class I Guideline recommended therapy for TR, in the form of annuloplasty, leaflet repair, or valve replacement. As growing experience of transcatheter therapy in structural heart disease, many dedicated transcatheter tricuspid repair or replacement devices, which mimic well-established surgical techniques, are currently under development. Nevertheless, many aspects of TR are little understood, including the disease process, surgical or interventional risk stratification, and predictors of successful therapy. The optimal treatment timing and the choice of proper surgical or interventional technique for significant TR remain to be elucidated. In this context, we aim to highlight the current evidence, underline major controversial issues in this field and present a future roadmap for TR therapy.

4.
Artigo em Inglês | MEDLINE | ID: mdl-31515695

RESUMO

Valve size selection for transcatheter aortic valve replacement (TAVR) is currently based on cardiac CT-scan. At variance with patient-specific computer simulation, this does not allow the assessment of the valve-host interaction. We aimed to compare clinical valve size selection and valve size selection by an independent expert for computer simulation. A multicenter retrospective analysis of valve size selection by the physician and the independent expert in 141 patients who underwent TAVR with the self-expanding CoreValve or Evolut R. Baseline CT-scan was used for clinical valve size selection and for patient-specific computer simulation. Simulation results were not available for clinical use. Overall true concordance between clinical and simulated valve size selection was observed in 47 patients (33%), true discordance in 15 (11%) and ambiguity in 79 (56%). In 62 (44%, cohort A) one valve size was simulated whereas two valve sizes were simulated in 79 (56%, cohort B). In cohort A, concordance was 76% and discordance was 24%; a smaller valve size was selected for simulation in 10 patients and a larger in 5. In cohort B, a different valve size was selected for simulation in all patients in addition to the valve size that was used for TAVR. The different valve size concerned a smaller valve in 45 patients (57%) and a larger in 34 (43%). Selection of the valve size differs between the physician and the independent computer simulation expert who used the same source of information. These findings indicate that valve sizing in TAVR is still more intricate than generally assumed.

6.
Circulation ; 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31476897

RESUMO

BACKGROUND: For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach. METHODS: The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years. RESULTS: Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76). CONCLUSIONS: For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG. CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov Unique Identifier: NCT01586910.

7.
EuroIntervention ; 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31475906

RESUMO

AIMS: Stent thrombosis (ST) is a rare but potentially fatal complication of coronary artery stenting. Little is known about the optimal treatment strategy at the time of a ST event. We identified the incidence and predictors of adverse cardiac events after treatment of a definite ST. METHODS AND RESULTS: 695 patients with definite ST were included between 1996 and 2017 in 2 academic medical centres. The primary endpoint was the composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) (MACE). Mean age was 62.8 ± 12.1 years and 76.3% were male. ST occurred at a median of 22 days (IQR 3-551 days); 50.8% were early and 49.2% were late/very late ST. At 60 months follow-up, MACE was 43.7%, cardiac death 19.5%, MI 17.9%, TVR 24.8%, and repeat definite ST was 12.1% (10.5% in target vessel). Independent predictors of MACE were cardiogenic shock (HR 2.54; 95%CI 1.75-3.70; p<0.001), ST in LAD (HR 1.76; 95%CI 1.32-2.35; p<0.001) prior CVA/TIA (HR 1.68; 95%CI 1.08-2.62; p=0.020), peripheral vascular disease (HR 1.55; 95%CI 1.00-2.39; p=0.046), multivessel disease (HR 1.53; 95%CI 1.12-2.08; p=0.007), and final TIMI flow 2-3 (HR 0.54; 95% CI 0.34-0.85; p=0.009). No specific treatment of ST influenced MACE, however, new generation P2Y12 inhibitors reduced the risk of MI (HR 0.56; 95% CI 0.32-0.99; p=0.049). CONCLUSIONS: The incidence of adverse events remains high after a first episode of ST. New generation P2Y12 inhibitors reduce the risk of MI. Additional stenting, GpIIb/IIIa inhibitors and thrombectomy did not improve outcomes following ST.

8.
Br J Anaesth ; 123(5): 565-569, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31547970

RESUMO

This case series presents 10 patients undergoing vascular surgery with asymptomatic elevated high-sensitivity troponin T concentrations, measured at outpatient clinic before surgery. Patients were included in the RAVE (Rotterdam Antiplatelet therapy in Vascular patiEnts) pilot study. All included patients underwent coronary angiography before surgery to identify significant obstructive coronary artery disease. We identified five out of 10 patients with high-grade stenosis and high-risk angiographic features of left main and/or proximal left anterior descending coronary artery disease. The study was terminated prematurely before any subject reached the study endpoint of 1 yr follow-up. This case series provides more insight into the meaning of preoperative troponin elevation and coronary angiographic features in vascular surgery patients. TRIAL REGISTRY NUMBER: NL5803.


Assuntos
Angiografia Coronária/métodos , Doença da Artéria Coronariana/sangue , Doença da Artéria Coronariana/diagnóstico por imagem , Cuidados Pré-Operatórios/métodos , Troponina T/sangue , Procedimentos Cirúrgicos Vasculares , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/cirurgia , Método Duplo-Cego , Feminino , Humanos , Masculino , Projetos Piloto , Fatores de Risco
9.
Interv Cardiol Clin ; 8(4): 393-402, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31445723

RESUMO

Multiple transcatheter heart valve iterations have created an interesting range of options with which to perform transcatheter aortic valve replacement. The Lotus valve has several attractive features. The ability to eradicate even mild paravalvular leak mirrors the outcomes of surgical aortic valve replacement. New design iterations of the Lotus valve and refined sizing algorithms may help mitigate the need for permanent pacemaker implantation and consolidate its best-in-class results in terms of paravalvular leak. Ongoing trials should help define the safety and efficacy of the Lotus transcatheter heart valve in contemporary practice.

10.
Eur Heart J ; 2019 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-31435675

RESUMO

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.

11.
Artigo em Inglês | MEDLINE | ID: mdl-31301161

RESUMO

OBJECTIVE AND BACKGROUND: The study aim is to provide long-term clinical outcome after percutaneous coronary intervention (PCI) for unprotected left main coronary arteries (ULMCA) stenosis with the first-generation (1st -gen) drug-eluting stents (DES) in comparison to 2nd -gen DES, since this is largely unknown. METHODS: Between May 2002, and December 2014, a consecutive series of 656 all-comer patients underwent a PCI for ULMCA stenosis at the Erasmus Medical Center. A total of 235 patients were treated with 1st -gen DES, while a total of 421 patients were treated with 2nd -gen DES. RESULTS: Overall, the population consisted of 73% males and 58% presented with an acute coronary syndrome. Median follow-up time was 1,361 days (range from 0 to 5,031). At 5 years, the cumulative incidence of major adverse clinical events (the primary composite endpoint of all-cause death, any myocardial infarction or target lesion revascularization; MACE) did not differ between 1st - and 2nd -gen DES (36.8 vs. 38.6%, respectively, Log Rank p = .79, adjusted hazard ratio [HR] = 1.28 [95% confidence interval (CI) 0.94-1.74]). No difference was found in the individual endpoints of all-cause mortality (29.5 vs. 29% respectively, p = .88, adjusted HR = 1.19 [95% CI, 0.84-1.68]), target vessel myocardial infarction (5.0 vs. 8.4%, p = 0.17, adjusted HR = 1.75 [95% CI, 0.78-3.96]) and target lesion revascularization (8.1 vs. 9.8%, p = .94, adjusted HR = 1.16 [95% CI, 0.59-2.29]) between the 1st - and 2nd -gen DES cohorts, respectively. CONCLUSIONS: In this large cohort of consecutive patients treated for ULMCA stenosis, no significant differences were found in the safety and efficacy of 1st versus 2nd -gen DES at 5 years follow-up.

12.
EuroIntervention ; 15(5): 420-426, 2019 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-31147307

RESUMO

AIMS: Quantitative aortography using videodensitometry is a valuable tool for quantifying paravalvular regurgitation after TAVI, especially in the minimalist approach - without general anaesthesia. However, retrospective assessment of aortograms showed moderate feasibility of assessment. We sought to determine the prospective feasibility of quantitative aortography after a protocol of acquisition. METHODS AND RESULTS: This was a multicentre registry in Japan, Canada, the Netherlands and Germany including consecutive patients with Heart Team indication to undergo TAVI over a median period of 12 months. Operators performed final aortograms according to a pre-planned projection (either by CT or visually - Teng's rule). An independent core laboratory (Cardialysis) analysed all images for feasibility and for regurgitation assessment. From the four centres included in the present analysis, a total of 354 patients underwent TAVI following the acquisition protocol and all the aortograms were analysed by the core lab. The analyses were feasible in 95.5% (95% confidence interval [CI]: 93.2% to 97.5%) of the cases. This rate of analysable assessment was significantly higher than the feasibility in previous validation studies, such as in the RESPOND population (95.5% vs. 57.5%, p<0.0001). No differences were observed among different planning strategies (CT 96.5% vs. Teng's rule 93%, p=0.159; or Circle 98.5% vs. 3mensio 95.8% vs. Teng's rule 93%, p=0.247). CONCLUSIONS: ASSESS-REGURGE showed a high feasibility of assessment of regurgitation with quantitative aortography with protocoled acquisition. This may be of great importance for quantifying regurgitation in TAVI procedures (optimisation, guidance of post-dilatation), and in future clinical trials, in order to address sealing features of novel devices for TAVI objectively. ClinicalTrials.gov Identifier: NCT03644784.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica , Insuficiência da Valva Aórtica/cirurgia , Aortografia , Humanos , Valor Preditivo dos Testes , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
13.
Circ Cardiovasc Interv ; 12(6): e007605, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31195822

RESUMO

Background We aimed to compare the rate of neurological events in patients with or without cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR). Methods and Results Data on clinical end points including neurological events ≤30 days post-TAVR were collected for all patients who underwent transfemoral TAVR in 2 academic tertiary care institutions. Patients were matched through propensity scoring, which resulted in 333 pairs of patients with versus without CEP out of a total of 831 consecutive patients. The median age was 81 (76-85) years, and the median logistic EuroScore was 14% (9%-20%). The CEP group experienced less neurological events at 24 hours (1% versus 4%; P=0.035) and at 30 days (3% versus 7%; P=0.029). There were significantly more disabling strokes in unprotected patients at 30 days (1% versus 4%; P=0.039). CEP was associated with significantly fewer neurological events at 24 hours after TAVR (odds ratio, 0.20; 95% CI, 0.06-0.73; P=0.015) by multiple regression analysis, while age and valve type did not contribute significantly. Overall, 67% (2 of 3) in the CEP versus 83% (10 of 12) in the non-CEP cohort experienced neurological events in protected areas (ie, not dependent on the left vertebral artery). Conclusions The use of filter-based CEP during TAVR was associated with less neurological events, especially in CEP-protected brain territories.

15.
Can J Cardiol ; 35(9): 1114-1123, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31202537

RESUMO

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.

16.
EuroIntervention ; 15(7): 586-593, 2019 09 20.
Artigo em Inglês | MEDLINE | ID: mdl-31147306

RESUMO

AIMS: The haemodynamic effects of primary implantation of an intra-aortic balloon pump (IABP) versus inotropes in decompensated heart failure and low output (DHF-LO), but without an acute coronary syndrome, have not been investigated. We therefore aimed to investigate the effect of primary IABP implantation as compared to inotropes on haemodynamics in DHF-LO with no acute ischaemia. METHODS AND RESULTS: Patients (n=32) with DHF-LO despite IV diuretics were randomised to primary 50 mL IABP or inotropes (INO: enoximone or dobutamine). The primary endpoint was the improvement of organ perfusion assessed by ∆ mixed-venous oxygen saturation (SvO2) at 3 hours; secondary endpoints included ∆ cardiac power output (CPO), NT-proBNP proportional change, cumulative fluid balance and ∆ dyspnoea severity score, all at 48 hours. Data are presented as median (IQR). Patients were 60 (48-69) years old and 72% were male. Baseline SvO2 was 44 (39-53)%. ∆SvO2 was higher in the IABP group (+17 [+9; +24] vs. +5 [+2; +9]%, p<0.05). IABP patients had a higher ∆CPO, a greater relative reduction in NT-proBNP, a more negative cumulative fluid balance, and a greater reduction in dyspnoea severity score. There were no IABP-related serious adverse events (SAEs). Thirty-day mortality was 23% (IABP) vs. 44% (INO). CONCLUSIONS: Primary circulatory support by IABP showed a significant increase in improved organ perfusion assessed by SvO2.


Assuntos
Débito Cardíaco/fisiologia , Cardiotônicos/uso terapêutico , Dobutamina/uso terapêutico , Enoximona/uso terapêutico , Insuficiência Cardíaca/cirurgia , Hemodinâmica/fisiologia , Balão Intra-Aórtico/métodos , Idoso , Débito Cardíaco/efeitos dos fármacos , Feminino , Coração Auxiliar , Hemodinâmica/efeitos dos fármacos , Humanos , Balão Intra-Aórtico/efeitos adversos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
17.
JAMA Cardiol ; 2019 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-31215985

RESUMO

Importance: Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative. Objective: To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery. Design, Setting, and Participants: In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017. Interventions: A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR. Main Outcomes and Measures: The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year. Results: Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04). Conclusions and Relevance: Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up. Trial Registration: ClinicalTrials.gov identifier: NCT01586910.

18.
J Clin Monit Comput ; 2019 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-31089844

RESUMO

Evaluation of a new Windkessel model based pulse contour method (WKflow) to calculate stroke volume in patients undergoing intra-aortic balloon pumping (IABP). Preload changes were induced by vena cava occlusions (VCO) in twelve patients undergoing cardiac surgery to vary stroke volume (SV), which was measured by left ventricular conductance volume method (SVlv) and WKflow (SVwf). Twelve VCO series were carried out during IABP assist at a 1:2 ratio and seven VCO series were performed with IABP switched off. Additionally, SVwf was evaluated during nine episodes of severe arrhythmia. VCO's produced marked changes in SV over 10-20 beats. 198 paired data sets of SVlv and SVwf were obtained. Bland-Altman analysis for the difference between SVlv and SVwf during IABP in 1:2 mode showed a bias (accuracy) of 1.04 ± 3.99 ml, precision 10.9% and limits of agreement (LOA) of - 6.94 to 9.02 ml. Without IABP bias was 0.48 ± 4.36 ml, precision 11.6% and LOA of - 8.24 to 9.20 ml. After one thermodilution calibration of SVwf per patient, during IABP the accuracy improved to 0.14 ± 3.07 ml, precision to 8.3% and LOA to - 6.00 to + 6.28 ml. Without IABP the accuracy improved to 0.01 ± 2.71 ml, precision to 7.5% and LOA to - 5.41 to + 5.43 ml. Changes in SVlv and SVwf were directionally concordant in response to VCO's and during severe arrhythmia. (R2 = 0.868). The SVwf and SVlv methods are interchangeable with respect to measuring absolute stroke volume as well as tracking changes in stroke volume. The precision of the non-calibrated WKflow method is about 10% which improved to 7.5% after one calibration per patient.

19.
EuroIntervention ; 2019 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-31085504

RESUMO

AIMS: To validate novel software to calculate vessel Fractional Flow Reserve (vFFR) based on 3D-QCA and to assess inter-observer variability in patients who underwent routine pre procedural FFR assessment for intermediate coronary artery stenosis. METHODS AND RESULTS: In-vitro validation was performed in an experimental model. Clinical validation was performed in an observational, retrospective, single-center cohort study. A total of 100 patients presenting with stable angina or non-ST segment elevation myocardial infarction and an indication to perform FFR between Jan 2016 and Oct 2016 were included. vFFR was calculated based on the aortic root pressure along with two angiographic projections and validated against pressure wire-derived FFR. Mean FFR and vFFR were 0.82±0.08 and 0.84±0.07 respectively. A good linear correlation was found between FFR and vFFR (r=0.89; p<0.001). Assessment of vFFR had a low inter-observer variability (r=0.95; p<0.001). The diagnostic accuracy of vFFR in identifying lesions with an FFR≤0.80 was higher as compared with 3D-QCA: AUC 0.93 (95% CI: 0.88-0.97) vs. 0.66 (95% CI: 0.55-0.77) respectively. CONCLUSIONS: The 3D-QCA derived vFFR has a high linear correlation to invasively measured FFR, a high diagnostic accuracy to detect FFR ≤ 0.80 and a low inter-observer variability.

20.
Am Heart J ; 213: 66-72, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31128504

RESUMO

BACKGROUND: Post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is a significant predictor of major adverse cardiac events (MACE). The rationale for low post procedural FFR values often remains elusive based on angiographic findings alone, warranting further assessment using an FFR pullback or additional intravascular imaging. It is currently unknown if additional interventions intended to improve the PCI, decrease MACE rates. STUDY DESIGN: The FFR REACT trial is a prospective, single-center randomized controlled trial in which 290 patients with a post PCI FFR <0.90 will be randomized (1:1) to either standard of care (no additional intervention) or intravascular ultrasound (IVUS)-directed optimization of the FFR (treatment arm). Eligible patients are those treated with angiographically successful PCI for (un)stable angina or non-ST elevation myocardial infarction (MI). Assuming 45% of patients will have a post PCI FFR <0.90, approximately 640 patients undergoing PCI will need to be enrolled. Patients with a post PCI FFR ≥ 0.90 will be enrolled in a prospective registry. The primary end point is defined as a composite of cardiac death, target vessel MI and clinically driven target vessel revascularisation (target vessel failure) at 1 year. Secondary end points will consist of individual components of the primary end point, procedural success, stent thrombosis and correlations on clinical outcome, changes in post PCI Pd/Pa and FFR and IVUS derived dimensions. All patients will be followed for 3 years. CONCLUSION: The FFR-REACT trial is designed to explore the potential benefit of HD-IVUS-guided PCI optimization in patients with a post PCI FFR <0.90 (Dutch trial register: NTR6711).

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