Transcatheter and Surgical Aortic Valve Replacement in Patients with Recent Acute Heart Failure

Background. Patients with severe aortic stenosis and heart failure have poor prognosis, and their outcomes may be suboptimal even after transcatheter (TAVR) and surgical aortic valve replacement (SAVR). Methods. This is an analysis of the nationwide FinnValve registry, which included patients who underwent primary TAVR or SAVR with a bioprothesis for aortic stenosis. We evaluated the outcome of patients with acute heart failure (AHF) within 60 days prior to TAVR or SAVR. Results. The prevalence of recent AHF was 11.4% (484 of 4241 patients) in the SAVR cohort and 11.3% (210 of 1855 patients) in the TAVR cohort. In the SAVR cohort, AHF was associated with lower 30-day survival (91.3% vs 97.0%; adjusted odds ratio 1.801, 95% confidence interval [CI] 1.125-2.882) and 5-year survival (64.0% vs 81.2%; adjusted hazard ratio 1.482, 95% CI 1.207-1.821). SAVR patients with AHF had higher risk of major bleeding, need of mechanical circulatory support, acute kidney injury, prolonged hospital stay, and composite end-point (30-day mortality, stroke and/or acute kidney injury). Patients with AHF had a trend toward lower 30-day survival (crude rates 95.2% vs 97.9%; adjusted odds ratio 2.028, 95% CI 0.908-4.529) as well as significantly lower 5-year survival (crude rates 45.3% vs 58.5%; adjusted hazard ratio 1.530, 95% CI 1.185-1.976) also after TAVR. AHF increased the risk of acute kidney injury, prolonged hospital stay, and composite end-point after TAVR. Conclusions. Recent AHF is associated with increased risk of mortality and morbidity after SAVR and TAVR. These findings suggest that aortic stenosis patients should be referred for invasive treatment before the development of clinically evident heart failure.Peer reviewe

Indicatori PNE. Ieri, oggi e domani

L’edizione 2019 di PNE analizza 176 indicatori (72 di esito/processo, 74 di volumi di attività e 30 di ospedalizzazione), coprendo 11 aree cliniche. In questo articolo, riportiamo a titolo esemplificativo una selezione di indicatori riguardanti 4 aree cliniche con il duplice intento di rappresentare alcuni dei contenuti del PNE e di illustrare i cambiamenti temporali che è possibile apprezzare attraverso questo strumento di valutazione

Comparative Analysis of Prothrombin Complex Concentrate and Fresh Frozen Plasma in Coronary Surgery

BackgroundRecent studies suggested that prothrombin complex concentrate (PCC) might be more effective than fresh frozen plasma (FFP) to reduce red blood cell (RBC) transfusion requirement after cardiac surgery.MethodsThis is a comparative analysis of 416 patients who received FFP postoperatively and 119 patients who received PCC with or without FFP after isolated coronary artery bypass grafting (CABG).ResultsMixed-effects regression analyses adjusted for multiple covariates and participating centres showed that PCC significantly decreased RBC transfusion (67.2% vs. 87.5%, adjusted OR 0.319, 95%CI 0.136–0.752) and platelet transfusion requirements (11.8% vs. 45.2%, adjusted OR 0.238, 95%CI 0.097–0.566) compared with FFP. The PCC cohort received a mean of 2.7 ± 3.7 (median, 2.0, IQR 4) units of RBC and the FFP cohort received a mean of 4.9 ± 6.3 (median, 3.0, IQR 4) units of RBC (adjusted coefficient, −1.926, 95%CI −3.357–0.494). The use of PCC increased the risk of KDIGO (Kidney Disease: Improving Global Outcomes) acute kidney injury (41.4% vs. 28.2%, adjusted OR 2.300, 1.203–4.400), but not of KDIGO acute kidney injury stage 3 (6.0% vs. 8.0%, OR 0.850, 95%CI 0.258–2.796) when compared with the FFP cohort.ConclusionsThese results suggest that the use of PCC compared with FFP may reduce the need of blood transfusion after CABG.</p

Impact of gender on 10-year outcome after coronary artery bypass grafting

OBJECTIVES Our goal was to evaluate the impact of gender on the 10-year outcome of patients after isolated coronary artery bypass grafting (CABG) included in the Italian nationwide PRedictIng long-term Outcomes afteR Isolated coronary arTery bypass surgery (PRIORITY) study. METHODS The PRIORITY project was designed to evaluate the long-term outcomes of patients who underwent CABG and were included in 2 prospective multicentre cohort studies. The primary end point of this analysis was major adverse cardiac and cerebrovascular events. Baseline differences between the study groups were balanced with propensity score matching and inverse probability of treatment. Time to events was analysed using Cox regression and competing risk analysis. RESULTS The study population comprised 10 989 patients who underwent isolated CABG (women 19.6%). Propensity score matching produced 1898 well-balanced pairs. The hazard of major adverse cardiac and cerebrovascular event was higher in women compared to men [adjusted hazard ratio (HR) 1.13, 95% confidence interval (CI) 1.03–1.23; P = 0.009]. The incidence of major adverse cardiac and cerebrovascular event in women was significantly higher at 1 year (HR 1.31, 95% CI 1.11–1.55; P &lt; 0.001) and after 1 year (HR 1.11, 95% CI 1.00–1.24; P = 0.05). Mortality at 10 years in the matched groups was comparable (HR 1.04, 95% CI 0.93–1.16; P = 0.531). Women have significantly a higher 10-year risk of myocardial infarction (adjusted HR 1.40, 95% CI 1.17–1.68; P = 0.002) and percutaneous coronary intervention (adjusted HR 1.32, 95% CI 1.10–1.59; P = 0.003). CONCLUSIONS The present study documented an excess of non-fatal cardiac events after CABG among women despite comparable 10-year survival with men. These findings suggest that studies investigating measures of tertiary prevention are needed to decrease the risk of adverse cardiovascular events among women

Five-year outcomes of transfemoral transcatheter aortic valve replacement or surgical aortic valve replacement in a real world population final results from the OBSERVANT study

Abstract Background: The OBSERVANT study (Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study. Methods and Results: The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P=0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12–1.69; P=0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11–1.63; P=0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years. Conclusions: The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. These data need to be confirmed in randomized trials using new-generation TAVR devices

Transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with anaemia

Abstract Objectives: We compared the outcome of anaemic patients undergoing transcatheter (TAVI) and surgical aortic valve replacement (SAVR) for severe aortic valve stenosis. Methods: Anaemic patients (haemoglobin &lt;13.0 g/dL in men and &lt;12.0 g/dL in women) undergoing TAVI and SAVR from the OBSERVANT study were the subjects of this analysis. Results: Preoperative anaemia was an independent predictor of 3-year mortality after either TAVI (HR 1.37, 95% CI 1.12–1.68) and SAVR (HR 1.63, 95% CI 1.37–1.99). Propensity score matching resulted in 302 pairs with similar characteristics. Patients undergoing SAVR had similar 30-d mortality (3.6% versus 3.3%, p = .81) and stroke (1.3% versus 2.0%, p = .53) compared with TAVI. The rates of pacemaker implantation (18.6% versus 3.0%, p &lt; .001), major vascular damage (5.7% versus 0.4%, p &lt; .001) and mild-to-severe paravalvular regurgitation (47.4% versus 9.3%, p &lt; .001) were higher after TAVI, whereas acute kidney injury (50.7% versus 27.9%, p &lt; .001) and blood transfusion (70.0% versus 38.6%, p &lt; .001) were more frequent after SAVR. At 3-year, survival was 74.0% after SAVR and 66.3% after TAVI, respectively (p = .065), and freedom from MACCE was 67.6% after SAVR and 58.7% after TAVI, respectively (p = .049). Conclusions: These results suggest that TAVI is not superior to SAVR in patients with anaemia

Programma Nazionale Esiti (PNE)

Il lavoro di monitoraggio e supporto che da diversi anni AGENAS svolge attraverso il Piano Nazionale Esiti a livello nazionale e regionale, in favore dei decisori e dei professionisti sanitari impegnati nell’assistenza sanitaria, si arricchisce quest’anno di un valore aggiunto: i risultati dell’edizione 2021 offrono uno spaccato sull’emergenza epidemiologica e sulle dinamiche che il COVID-19 ha determinato rispetto all’organizzazione dei servizi, attraverso un confronto ampio e particolareggiato dei dati di attività relativi all’anno 2020 con quelli della fase pre-pandemica. La sistematicità e la capillarità dell’approccio PNE nel valutare comparativamente l’efficacia, l’appropriatezza, l’equità e la sicurezza delle cure garantite dal servizio Sanitario Nazionale contribuiscono, infatti, a mostrare in che misura e rispetto a quali ambiti i sistemi sanitari regionali abbiano tenuto di fronte all’urto pandemico, continuando a garantire alla popolazione l’erogazione dei servizi essenziali, e quanto sia stato invece differito. Quest’anno, inoltre, accanto ai tradizionali indicatori di performance, sono state introdotte nuove misure volte a valutare i volumi per singolo operatore, il timing di effettuazione di prestazioni chirurgiche salvavita e le disuguaglianze nell’assistenza sanitaria. I dati, elaborati attraverso il calcolo di 184 indicatori per svariati ambiti nosologici e setting assistenziali, ci mostrano la grande resilienza del SSN, a dispetto delle difficoltà che pure insistono sull’organizzazione sanitaria e che la pandemia ha esacerbato; e ci indicano la strada da battere per riprogrammare la sanità del futuro a partire da alcune criticità quali la frammentarietà della casistica ospedaliera, l’inappropriatezza clinica, la bassa tempestività e la disomogeneità nell’accesso ai trattamenti, per aree territoriali e con riferimento ai gruppi più vulnerabili della popolazione. Quanto ottenuto risulta particolarmente prezioso per la programmazione futura delle attività da parte delle Regioni e delle Province Autonome, i cui servizi sanitari sono stati gravati da questa situazione di crisi, in un’ottica di accompagnamento e re-indirizzo delle azioni volti prevalentemente al recupero delle prestazioni sanitarie non erogate e all’abbattimento dei tempi di attesa. Per il futuro, l’intento di AGENAS è quello di proseguire con le attività di monitoraggio e valutazione, anche nella prospettiva di sostenere la riorganizzazione del SSN dopo la pandemia, in una chiave di maggiore efficienza ed efficacia, facendo emergere e mettendo a sistema le esperienze virtuose, per contribuire alla diffusione delle buone prassi esistenti e orientare il cambiamento

Lo studio PRIORITY - PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY

La ripartizione delle risorse cliniche ed economiche è un problema emergente nella gestione della salute. Un aggiornamento utile dipende necessariamente dalla valutazione dei risultati a lungo termine delle procedure diagnostiche e terapeutiche, che possa consentire di evidenziare i limiti, migliorare la qualità delle cure e ridurre i costi sanitari. Lo studio PRIORITY (PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY) rappresenta il primo passo verso l’aggiornamento della gestione della salute in uno specifico campo, la chirurgia per la malattia coronarica, che è una delle più diffuse malattie e richiede allocazione di risorse ad alto costo, sebbene le informazioni sui risultati a lungo termine siano limitate. Gli obiettivi dello studio PRIORITY sono l’identificazione dei fattori di rischio preoperatori per risultati a lungo termine e lo sviluppo di score di rischio clinici e amministrativi che possano guidare i medici e il sistema sanitario nazionale al fine di ottenere migliori risultati clinici e ridurre i costi