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INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has put tremendous pressure on healthcare systems. Most transcatheter aortic valve implantation (TAVI) centres have adopted different triage systems and procedural strategies to serve highest-risk patients first and to minimise the burden on hospital logistics and personnel. We therefore assessed the impact of the COVID-19 pandemic on patient selection, type of anaesthesia and outcomes after TAVI. METHODS: We used data from the Netherlands Heart Registration to examine all patients who underwent TAVI between March 2020 and July 2020 (COVID cohort), and between March 2019 and July 2019 (pre-COVID cohort). We compared patient characteristics, procedural characteristics and clinical outcomes. RESULTS: We examined 2131 patients who underwent TAVI (1020 patients in COVID cohort, 1111 patients in pre-COVID cohort). EuroSCORE II was comparable between cohorts (COVID 4.5⯱ 4.0 vs pre-COVID 4.6⯱ 4.2, pâ¯= 0.356). The number of TAVI procedures under general anaesthesia was lower in the COVID cohort (35.2% vs 46.5%, pâ¯< 0.001). Incidences of stroke (COVID 2.7% vs pre-COVID 1.7%, pâ¯= 0.134), major vascular complications (2.3% vs 3.4%, pâ¯= 0.170) and permanent pacemaker implantation (10.0% vs 9.4%, pâ¯= 0.634) did not differ between cohorts. Thirty-day and 150-day mortality were comparable (2.8% vs 2.2%, pâ¯= 0.359 and 5.2% vs 5.2%, pâ¯= 0.993, respectively). CONCLUSIONS: During the COVID-19 pandemic, patient characteristics and outcomes after TAVI were not different than before the pandemic. This highlights the fact that TAVI procedures can be safely performed during the COVID-19 pandemic, without an increased risk of complications or mortality.
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Although there is robust evidence that revascularisation of non-culprit vessels should be pursued in patients presenting with an acute coronary syndrome (ACS) and multivessel coronary artery disease (MVD), the optimal timing of complete revascularisation remains disputed. In this systematic review and meta-analysis our results suggest that outcomes are comparable for immediate and staged complete revascularisation in patients with ACS and MVD. However, evidence from randomised controlled trials remains scarce and cautious interpretation of these results is recommended. More non-biased evidence is necessary to aid future decision making on the optimal timing of complete revascularisation.
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AIM: To evaluate the distribution of a generic diastolic pressure ratio (dPR) after angiographically successful percutaneous coronary intervention (PCI) and to assess its association with the 2year incidence of target vessel failure (TVF), defined as a composite of cardiac mortality, target vessel revascularisation, target vessel myocardial infarction and stent thrombosis. METHODS: The dPR SEARCH study is a post hoc analysis of the prospective single-centre FFR-SEARCH registry, in which physiological assessment was performed after angiographically successful PCI in a total of 1000 patients, using a dedicated microcatheter. dPR was calculated offline with recently validated software in a subset of 735 patients. RESULTS: Mean post-PCI dPR was 0.95⯱ 0.06. Post-PCI dPR was ≤â¯0.89 in 15.2% of the patients. The cumulative incidence of TVF at 2year follow-up was 9.4% in patients with a final post-PCI dPR ≤â¯0.89 as compared to 6.1% in patients with a post-PCI dPR >â¯0.89 (adjusted hazard ratio [HR] for dPR ≤â¯0.89: 1.53; 95% CI 0.74-3.13; pâ¯= 0.249). dPR ≤â¯0.89 was associated with significantly higher cardiac mortality at 2 years; adjusted HR 2.40; 95% CI 1.01-5.68; pâ¯= 0.047. CONCLUSIONS: In a real-world setting, despite optimal angiographic PCI results, 15.2% of the patients had a final post-PCI dPR of ≤â¯0.89, which was associated with a higher incidence of TVF and a significantly higher cardiac mortality rate.
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INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has matured to the treatment of choice for most patients with aortic stenosis (AS). We sought to identify trends in patient and procedural characteristics, and clinical outcomes in all patients who underwent TAVI between 2005 and 2020. METHODS: A single-centre analysis was performed on 1500 consecutive patients who underwent TAVI, divided into three tertiles (T) of 500 patients treated between November 2005 and December 2014 (T1), January 2015 and May 2018 (T2) and June 2018 and April 2020 (T3). RESULTS: Over time, mean age and gender did not change (T1 to T3: 80, 80 and 79 years and 53%, 55% and 52% men, respectively), while the Society of Thoracic Surgeons risk score declined (T1: 4.5% to T3: 2.7%, pâ¯< 0.001). Use of general anaesthesia also declined over time (100%, 24% and 1% from T1 to T3) and transfemoral TAVI remained the default approach (87%, 94% and 92%). Median procedure time and contrast volume decreased significantly (186, 114 and 56â¯min and 120, 100 and 80â¯ml, respectively). Thirty-day mortality (7%, 4% and 2%), stroke (7%, 3% and 3%), need for a pacemaker (19%, 22% and 8%) and delirium (17%, 12% and 8%) improved significantly, while major bleeding/vascular complications did not change (both approximately 9%, 6% and 6%). One-year survival was 80%, 88% and 92%, respectively. CONCLUSION: Over our 15 years' experience, patient age remained unchanged but the patient risk profile became more favourable. Simplification of the TAVI procedure occurred in parallel with major improvement in outcomes and survival. Bleeding/vascular complications and the need for pacemaker implantation remain the Achilles' heel of TAVI.
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INTRODUCTION: The aim of the present study was to assess the safety and efficacy of renal sympathetic denervation (RDN) in patients with heart failure with reduced ejection fraction (HFrEF). METHODS: We randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤â¯35% and NYHA class ≥â¯II, in a 1:1 ratio, to either RDN and optimal medical therapy (OMT) or OMT alone. The primary safety endpoint was the occurrence of a combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6 months. The primary efficacy endpoint was the change in iodine-123 meta-iodobenzylguanidine (123IMIBG) heart-to-mediastinum ratio (HMR) at 6 months. RESULTS: Mean age was 60⯱ 9 years, 86% was male and mean LVEF was 33⯱ 8%. At 6 months, the primary safety endpoint occurred in 8.3% vs 8.0% in the RDN and OMT groups, respectively (pâ¯= 0.97). At 6 months, the mean change in late HMR was -0.02 (95% CI: -0.08 to 0.12) in the RDN group, versus -0.02 (95% CI: -0.09 to 0.12) in the OMT group (pâ¯= 0.95) whereas the mean change in washout rate was 2.34 (95% CI: -6.35 to 1.67) in the RDN group versus -2.59 (95% CI: -1.61 to 6.79) in the OMT group (p-value 0.09). CONCLUSION: RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using 123IMIBG.
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OBJECTIVE: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs). METHODS: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database. RESULTS: TAVI was performed with CoreValve (nâ¯= 116), Evolut R (nâ¯= 160) or Evolut PRO (nâ¯= 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, pâ¯= 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31-5.94, pâ¯= 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, pâ¯= 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (Râ¯+ PRO) (OR 2.46, 95% CI 0.98-6.16, pâ¯= 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, pâ¯= 0.10), stroke (6% vs 3% vs 2%, pâ¯= 0.21) or major vascular complications (10% vs 12% vs 4%, pâ¯= 0.14) were observed. CONCLUSIONS: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.
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BACKGROUND: The integration of computed tomography (CT)-derived left ventricular outflow tract area into the echocardiography-derived continuity equation results in the reclassification of a significant proportion of patients with severe aortic stenosis (AS) into moderate AS based on aortic valve area indexed to body surface area determined by fusion imaging (fusion AVAi). The aim of this study was to evaluate AS severity by a fusion imaging technique in patients with low-gradient AS and to compare the clinical impact of reclassified moderate AS versus severe AS. METHODS: We included 359 consecutive patients who underwent transcatheter aortic valve implantation for low-gradient, severe AS at two academic institutions and created a joint database. The primary endpoint was a composite of all-cause mortality and rehospitalisations for heart failure at 1 year. RESULTS: Overall, 35% of the population (nâ¯= 126) were reclassified to moderate AS [median fusion AVAi 0.70 (interquartile range, IQR 0.65-0.80)â¯cm2/m2] and severe AS was retained as the classification in 65% [median fusion AVAi 0.49 (IQR 0.43-0.54) cm2/m2]. Lower body mass index, higher logistic EuroSCORE and larger aortic dimensions characterised patients reclassified to moderate AS. Overall, 57% of patients had a left ventricular ejection fraction (LVEF) <50%. Clinical outcome was similar in patients with reclassified moderate or severe AS. Among patients reclassified to moderate AS, non-cardiac mortality was higher in those with LVEF <50% than in those with LVEF ≥50% (log-rank pâ¯= 0.029). CONCLUSIONS: The integration of CT and transthoracic echocardiography to obtain fusion AVAi led to the reclassification of one third of patients with low-gradient AS to moderate AS. Reclassification did not affect clinical outcome, although patients reclassified to moderate AS with a LVEF <50% had worse outcomes owing to excess non-cardiac mortality.
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BACKGROUND: Functional mitral regurgitation (FMR) can be subclassified based on its proportionality relative to left ventricular function and end-diastolic volume. FMR proportionality could help identify responders to transcatheter edge-to-edge mitral valve repair (MitraClip) in terms of residual FMR and/or clinical improvement. METHODS: This single-centre retrospective cohort study evaluated the feasibility of determining FMR proportionality in symptomatic heart failure patients with reduced left ventricular function who were treated with MitraClip forâ¯≥ moderate-to-severe FMR. Baseline proportionate (pFMR) and disproportionate FMR (dFMR) were distinguished. Patient characteristics and MitraClip procedural outcomes were described. RESULTS: From an overall cohort of 81 eligible FMR patients, 23/81 (28%) had to be excluded due to missing transthoracic echocardiogram parameters, 22/81 were excluded based on FMR severity. The remaining cohort, of 36/81 patients (44%), could be classified into dFMR (nâ¯= 26) or pFMR (nâ¯= 10). Conduction disorders were numerically increased in dFMR. All cases requiring >â¯2 clips were in the dFMR group and absence of FMR reduction occurred more frequently with dFMR. POINT OF VIEW/CONCLUSION: Important limitations in terms of imaging acquisition affect the translation of the FMR proportionality concept to a real-world data set. We did observe different demographic and FMR response patterns in patients with proportionate and disproportionate FMR that warrant further investigation.
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In the analysis of composite endpoints in a clinical trial, time to first event analysis techniques such as the logrank test and Cox proportional hazard test do not take into account the multiplicity, importance, and the severity of events in the composite endpoint. Several generalized pairwise comparison analysis methods have been described recently that do allow to take these aspects into account. These methods have the additional benefit that all types of outcomes can be included, such as longitudinal quantitative outcomes, to evaluate the full treatment effect. Four of the generalized pairwise comparison methods, ie, the Finkelstein-Schoenfeld, the Buyse, unmatched Pocock, and adapted O'Brien test, are summarized. They are compared to each other and to the logrank test by means of simulations while specifically evaluating the effect of correlation between components of the composite endpoint on the power to detect a treatment difference. These simulations show that prioritized generalized pairwise comparison methods perform very similarly, are sensitive to the priority rank of the components in the composite endpoint, and do not measure the true treatment effect from the second priority-ranked component onward. The nonprioritized pairwise comparison test does not suffer from these limitations and correlation affects only its variance.
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Determinação de Ponto Final/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Bioestatística , Simulação por Computador , Interpretação Estatística de Dados , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Humanos , Modelos Estatísticos , Estatísticas não Paramétricas , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter , Resultado do TratamentoRESUMO
INTRODUCTION: Together with antiplatelet therapy, anticoagulants are vital to improve outcomes in patients presenting with ST-segment elevation myocardial infarction. Challenges lie in finding the optimal balance between the risk of bleeding and preventing thrombotic complications such as reinfarction or stent thrombosis. During the last decade, bivalirudin was introduced as a valid alternative to heparin for patients undergoing primary percutaneous coronary intervention. Several trials have been conducted to identify the agent with the best antithrombotic results at the lowest bleeding complication rate. In a rapidly evolving field with changes in vascular access, available P2Y12 inhibitors, and indications for glycoprotein IIb/IIIa inhibitor administration, conflicting evidence became available. AREAS COVERED: This paper mainly focuses on the evidence above and gives brief discussion to the recent literature on anticoagulation in fibrinolytic therapy and advances in antiplatelet therapy. EXPERT OPINION: To date, no robust evidence is available challenging unfractionated heparin as the primary choice for anticoagulation in patients presenting with ST-segment elevation myocardial infarction. Further research should include efforts to refine anticoagulation strategies on an individual patient level. For patients undergoing primary percutaneous coronary intervention, bivalirudin could be used as an alternative to unfractionated heparin, while enoxaparin or fondaparinux is an alternative agent for patients treated with fibrinolytic therapy.
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Anticoagulantes/uso terapêutico , Heparina/uso terapêutico , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Hemorragia/induzido quimicamente , Hirudinas , Humanos , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea/métodos , Proteínas Recombinantes/uso terapêutico , Terapia Trombolítica/métodos , Trombose/prevenção & controle , Resultado do TratamentoRESUMO
We report the first patient experiences with the CardioMEMS device in the Erasmus MC Thorax Center in the Netherlands. In line with clinical trial evidence, the device is applicable in patients with chronic heart failure in functional New York Heart Association class III with at least 1 admission for heart failure in the past 12 months. CardioMEMS has been shown to be safe and reliable, and effective in reducing the number of hospitalisations for heart failure by guided therapy based on pulmonary artery pressures.
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OBJECTIVES: Renal sympathetic denervation has been studied as a potential therapeutic option for patients with therapy-resistant hypertension; however, a significant proportion of patients do not show a significant reduction in blood pressure and are classified as non-responders. The objective of the present study was to assess whether a redo renal denervation procedure increases response rates. METHODS: We present a case series of three consecutive renal denervation non-responders treated with the multi-electrode radiofrequency St. Jude EnligHTN catheter after an average of 22 months. Patients were followed for 6 months. RESULTS: Mean age was 66 years and two patients were male. Patients were previously treated using either ReCor's Paradise system, the Vessix V2 system or the Covidien OneShot system. Mean office blood pressure one year after the initial procedure was 187/102 mm Hg with a mean 24 h ambulatory blood pressure of 166/102 mm Hg. All patients underwent a successful redo procedure using the EnligHTN system because of persistent therapy-resistant hypertension. At 6 months a significant drop in both office and ambulatory blood pressure of -27/-6 mm Hg and -15/-13 mm Hg, respectively, was observed. No significant renal artery stenosis was observed at 6 months. CONCLUSIONS: In patients with therapy-resistant hypertension who do not respond to an initial renal denervation procedure, a redo procedure using the St. Jude EnligHTN system may help to significantly improve blood pressure control.
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PURPOSE: Data on MitraClip procedural safety and efficacy in the Netherlands are scarce. We aim to provide an overview of the Dutch MitraClip experience. METHODS: We pooled anonymised demographic and procedural data of 1151 consecutive MitraClip patients, from 13 Dutch hospitals. Data was collected by product specialists in collaboration with local operators. Effect on mitral regurgitation was intra-procedurally assessed by transoesophageal echocardiography. Technical success and device success were defined according to modified definitions of the Mitral Valve Academic Research Consortium (MVARC). RESULTS: Median age was 76 (interquartile range 69-82) years and 59% were males. Patients presented with ≥moderate mitral regurgitation and a predominance of functional mitral regurgitation (72%). Overall, 611 (53%) patients were treated with one Clip, 486 (42%) with ≥2 Clips and 54 (5%) received no Clip. The number of patients with ≥2 Clips increased from 22% in 2009 to 52% in 2016. Device success and technical success were 91 and 95%, respectively, and were consistent over the years. Significant reduction of mitral regurgitation by MitraClip was achieved in 94% of patients and was observed more often in patients with functional mitral regurgitation (95% vs. 91%, p = 0.025). Device time declined from 145 min in 2009 to 55 min in 2016. CONCLUSION: MitraClip experience in the Netherlands is growing with excellent technical success and device success. Over the years, device time decreased and more patients were treated with ≥2 Clips.
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Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. The objective of this paper is to present such a model and illustrate its potential clinical utility via a few case studies.
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OBJECTIVES: To investigate one-year outcomes after implantation of a bioresorbable vascular scaffold (BVS) in patients presenting with acute coronary syndrome (ACS) compared to stable angina patients. BACKGROUND: Robust data on the outcome of BVS in the setting of ACS is still scarce. METHODS: Two investigator initiated, single-center, single-arm BVS registries have been pooled for the purpose of this study, namely the BVS Expand and BVS STEMI registries. RESULTS: From September 2012-October 2014, 351 patients with a total of 428 lesions were enrolled. 255 (72.6%) were ACS patients and 99 (27.4%) presented with stable angina/silent ischemia. Mean number of scaffold/patient was 1.55±0.91 in ACS group versus 1.91±1.11 in non-ACS group (P=0.11). Pre- and post-dilatation were performed less frequent in ACS patients, 75.7% and 41.3% versus 89.0% and 62.0% respectively (P=0.05 and P=0.001). Interestingly, post-procedural acute lumen gain and percentage diameter stenosis were superior in ACS patients, 1.62±0.65mm (versus 1.22±0.49mm, P<0.001) and 15.51±8.47% (versus 18.46±9.54%, P=0.04). Major adverse cardiac events (MACE) rate at 12months was 5.5% in the ACS group (versus 5.3% in stable group, P=0.90). One-year definite scaffold thrombosis rate was comparable: 2.0% for ACS population versus 2.1% for stable population (P=0.94), however, early scaffold thromboses occurred only in ACS patients. CONCLUSIONS: One-year clinical outcomes in ACS patients treated with BVS were similar to non-ACS patients. Acute angiographic outcomes were better in ACS than in non-ACS, yet the early thrombotic events require attention and further research.
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Implantes Absorvíveis , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/cirurgia , Sistema de Registros , Alicerces Teciduais , Síndrome Coronariana Aguda/mortalidade , Adulto , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Taxa de Sobrevida/tendênciasRESUMO
Contact force (CF) is one of the major determinants for sufficient lesion formation. CF-guided procedures are associated with enhanced lesion formation and procedural success. We report our initial experience in epicardial ventricular tachycardia (VT) ablation with a force-sensing catheter using a new approach with an angioplasty balloon. Two patients with arrhythmogenic right ventricular cardiomyopathy who underwent prior unsuccessful endocardial ablation were treated with epicardial VT ablation. CF data were used to titrate force, power and ablation time.
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AIMS: Transcatheter aortic valve implantation (TAVI) is frequently complicated by new left bundle branch block (LBBB). We investigated the development and persistence of LBBB during follow-up and its clinical consequences. METHODS AND RESULTS: ECGs at baseline, within 24 hours, before discharge and at 12 months after TAVI were assessed in 476 patients without pre-existing LBBB and/or pacemaker before or after TAVI. TAVI-induced new LBBB was categorised based on the timing of the occurrence (within 24 hours [acute], after 24 hours but before discharge [subacute], and after discharge [late]), in addition to persistence (transient or persistent). A total of 175 patients (36.8%) developed new LBBB of which 85.7% occurred within 24 hours after TAVI, 12.0% before and 2.3% after hospital discharge, and was persistent in 111 patients (63.4%). Implantation of the Medtronic CoreValve System (MCS) more frequently led to new LBBB than the balloon-expandable Edwards SAPIEN valve (ES) (53.8% versus 21.7%) with less recovery during follow-up (39.0% versus 9.5%). Late new LBBB was only seen in four patients (0.8%). During a median follow-up of 915 (578-1,234) days, persistent LBBB was associated with a significant increase in mortality as compared to no LBBB and temporary LBBB combined (hazard ratio 1.49, 95% confidence interval, 1.10-2.03; p=0.01). CONCLUSIONS: TAVI-induced new LBBB occurs in almost 40% of patients, almost all before hospital discharge. It occurs three times more frequently after MCS than after ES valve implantation and has a twofold lower tendency to resolve during follow-up. Persistent LBBB is associated with a higher mortality.
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Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/epidemiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Bloqueio de Ramo/mortalidade , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Eletrocardiografia , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Incidência , Masculino , Prognóstico , Estudos Prospectivos , Estudos Retrospectivos , Taxa de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Percutaneous transluminal septal myocardial ablation using microsphere embolisation is a new interventional technique to treat patients with hypertrophic obstructive cardiomyopathy. METHODS AND RESULTS: In two patients, considered at high risk for myectomy, targeted septal perforators were occluded with microsphere embolisation instead of alcohol ablation to reduce left ventricular outflow gradient. In both cases the left ventricular outflow tract gradient was immediately reduced. No adverse events occurred. CONCLUSION: This is the first clinical experience with Embozene® Microspheres in the Netherlands as an alternative for alcohol septal ablation. In both cases it resulted in immediate improvement in the haemodynamics, without any adverse events.
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Transcatheter aortic valve implantation (TAVI) implies the introduction, positioning, and deployment of a stented bioprosthesis in the (calcified) native aortic valve. We report an at first glance uneventful TAVI with the Medtronic Corevalve System, which was followed by transient electrocardiographic changes suggesting acute left main stem disease. The diagnosis of acute left main stem dissection extending from the left coronary cusp was firmly established by intravascular ultrasound. The ostium of the left main stem was successfully treated with intravascular ultrasound-guided placement of a drug eluting stent.