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1.
J Clin Med ; 13(15)2024 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-39124754

RESUMEN

Background/Objectives: Mitral regurgitation (MR) affects millions worldwide, necessitating timely intervention. There are significant clinical challenges in the conservative management of MR, leaving a knowledge gap regarding the impact of multidisciplinary decision-making on treatment outcomes. This study aimed to provide insights into the impact of multidisciplinary decision-making on the survival outcomes of MR patients, focusing on conservative approaches. Methods: This study retrospectively analyzes 1365 patients evaluated by an expert multidisciplinary heart team (MDT) in a single center from 2015 to 2022. Treatments included surgery, catheter-based interventions, and conservative management. Propensity matching was utilized to compare surgery and conservative approaches. Results: Surgical intervention was associated with superior long-term survival outcomes compared to conservative and catheter-based treatments, particularly for degenerative MR (DMR). Survival rates of patients deemed by the MDT to have non-severe DMR were comparable to surgical patients (HR 1.07, 95% CI: 0.37-3.12, p = 0.90). However, non-severe functional MR (FMR) patients trended towards elevated mortality risk (HR 1.77, 95% CI: 0.94-3.31, p = 0.07). Pharmacological treatment for DMR was associated with significantly higher mortality compared to surgery (HR 8.0, 95% CI: 1.78-36.03, p = 0.001). Functional MR patients treated pharmacologically exhibited a non-significantly higher mortality risk compared to surgical intervention (HR 1.93, 95% CI: 0.77-4.77, p = 0.20). Conclusions: Survival analysis revealed significant benefits for surgical intervention, contrasting with elevated mortality risks associated with conservative management. "Watchful waiting" may be appropriate for non-severe DMR, while FMR may require closer monitoring. Further research is needed to assess the impact of regular follow-up or delayed surgery on survival rates, as pharmacological therapy has limited long-term efficacy for DMR.

2.
JAMA Cardiol ; 2024 Aug 14.
Artículo en Inglés | MEDLINE | ID: mdl-39141396

RESUMEN

Importance: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce. Objective: To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI. Design, Setting, and Participants: The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 3 Australian hospitals between December 2021 and June 2023 with a 1-year follow-up period. All patients accepted for transfemoral TAVI by a multidisciplinary heart team were eligible for enrollment. Interventions: Eligible patients were randomized 1:1 between routine protamine administration and placebo. Main Outcomes and Measures: The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a χ2 test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P values. Results: The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. The median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of 199 patients receiving protamine (34.2%) were female. The median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of 211 patients receiving the placebo (42.2%) were female. Patients receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P = .006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P = .002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P = .01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use. Conclusions and Relevance: In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay duration in patients receiving routine protamine compared with patients receiving placebo. Trial Registration: anzctr.org.au Identifier: ACTRN12621001261808.

3.
Artículo en Inglés | MEDLINE | ID: mdl-39115889

RESUMEN

OBJECTIVES: Myocardial ischaemia following coronary artery bypass grafting (CABG) is a potentially devastating complication. Nevertheless, the incidence, aetiology, and prognostic relevance of unplanned CAG remain understudied. We aimed to investigate the prevalence and outcome of patients undergoing urgent, unplanned coronary angiography in the postoperative period following CABG. METHODS: We screened all patients undergoing isolated elective CABG in an academic referral centre between 2016-2021 and identified patients undergoing unplanned CAG (uCAG) within 30 days of surgery. Within uCAG patients, a distinction was made between patients undergoing re-revascularization (REV) and patients receiving conservative management (CON). The primary outcomes were 30-day mortality and unadjusted and adjusted long-term survival. Secondary outcomes were the indication for and prevalence of uCAG and urgent revascularization. RESULTS: Of the 1918 patients undergoing isolated CABG, 78 individuals needed uCAG (4.1%), of which 45 underwent immediate revascularization (REV-group; 2.3% overall, 57% within the uCAG group, median age 69.9 years) and 33 were treated conservatively (CON-group; 1.7% overall, 42% within the uCAG group, median age 69.1 years). Patients undergoing uCAG (n = 78) had a higher 30-day mortality than patients not undergoing uCAG (n = 1840, 30-day mortality: 9.0% vs 0.4%, p < 0.001). Long-term survival was significantly decreased in patients undergoing uCAG in both unadjusted (hazard ratio [HR] 2.20, 95% CI 1.30-3.73), and EuroSCORE-, age-, and sex-adjusted models (HR uCAG 2.03, 95% CI 1.16-3.56). CONCLUSIONS: Unplanned postoperative CAG is performed in 4.1% of isolated CABG procedures, and patients in need of such urgent invasive evaluation are subjected to decreased short- and long-term survival.

4.
Ann Thorac Surg ; 2024 Jul 02.
Artículo en Inglés | MEDLINE | ID: mdl-38964702

RESUMEN

BACKGROUND: The impact of sex-differences on the release of cardiac biomarkers after coronary artery bypass grafting (CABG) remains unknown. The aim of our study was to (a) investigate the impact of sex-differences in cardiac biomarker release after CABG and (b) determine sex-specific thresholds for high-sensitivity troponin (hs-cTn) and creatine kinase-MB (CK-MB) associated with 30-day major adverse cardiovascular event (MACE) and mortality. METHODS: A consecutive cohort of 3687 patients (female: n= 643 (17.4%); male: 3044 (82.6%) undergoing CABG from 2008-2021 in two tertiary university centers with serial postoperative cTn and CK-MB measurement was analyzed. The composite primary outcome was MACE at 30 days. Secondary endpoints were 30-day mortality and five-year mortality and MACE. Sex-specific thresholds for cTn and CK-MB were determined. RESULTS: Lower levels of cTn were found in women after CABG (69.18 vs. 77.57 xURL; p<0.001). Optimal threshold value for cTn was calculated at 94.36 times the URL for female and 206.07 times the URL for male patients to predict 30-day MACE. Female patients missed by a general threshold had increased risk for MACE or death within 30 days (cTn: MACE: OR 3.78 CI: 1.03-13.08; p=0.035; death: OR 4.98; CI: 1.20.-20.61; p=0.027; CK-MB: MACE: OR 10.04; CI: 2.07-48.75; p<0.001; death: OR 13.59; CI: 2.66-69.47; p=0.002). CONCLUSIONS: We provide evidence for sex-specific differences in the outcome and biomarker release after CABG. Sex-specific cut-offs are necessary for the diagnosis of perioperative myocardial injury to improve outcomes of women after CABG.

5.
Crit Care ; 28(1): 217, 2024 Jul 03.
Artículo en Inglés | MEDLINE | ID: mdl-38961495

RESUMEN

BACKGROUND: The outcomes of several randomized trials on extracorporeal cardiopulmonary resuscitation (ECPR) in patients with refractory out-of-hospital cardiac arrest were examined using frequentist methods, resulting in a dichotomous interpretation of results based on p-values rather than in the probability of clinically relevant treatment effects. To determine such a probability of a clinically relevant ECPR-based treatment effect on neurological outcomes, the authors of these trials performed a Bayesian meta-analysis of the totality of randomized ECPR evidence. METHODS: A systematic search was applied to three electronic databases. Randomized trials that compared ECPR-based treatment with conventional CPR for refractory out-of-hospital cardiac arrest were included. The study was preregistered in INPLASY (INPLASY2023120060). The primary Bayesian hierarchical meta-analysis estimated the difference in 6-month neurologically favorable survival in patients with all rhythms, and a secondary analysis assessed this difference in patients with shockable rhythms (Bayesian hierarchical random-effects model). Primary Bayesian analyses were performed under vague priors. Outcomes were formulated as estimated median relative risks, mean absolute risk differences, and numbers needed to treat with corresponding 95% credible intervals (CrIs). The posterior probabilities of various clinically relevant absolute risk difference thresholds were estimated. RESULTS: Three randomized trials were included in the analysis (ECPR, n = 209 patients; conventional CPR, n = 211 patients). The estimated median relative risk of ECPR for 6-month neurologically favorable survival was 1.47 (95%CrI 0.73-3.32) with a mean absolute risk difference of 8.7% (- 5.0; 42.7%) in patients with all rhythms, and the median relative risk was 1.54 (95%CrI 0.79-3.71) with a mean absolute risk difference of 10.8% (95%CrI - 4.2; 73.9%) in patients with shockable rhythms. The posterior probabilities of an absolute risk difference > 0% and > 5% were 91.0% and 71.1% in patients with all rhythms and 92.4% and 75.8% in patients with shockable rhythms, respectively. CONCLUSION: The current Bayesian meta-analysis found a 71.1% and 75.8% posterior probability of a clinically relevant ECPR-based treatment effect on 6-month neurologically favorable survival in patients with all rhythms and shockable rhythms. These results must be interpreted within the context of the reported credible intervals and varying designs of the randomized trials. REGISTRATION: INPLASY (INPLASY2023120060, December 14th, 2023, https://doi.org/10.37766/inplasy2023.12.0060 ).


Asunto(s)
Teorema de Bayes , Reanimación Cardiopulmonar , Paro Cardíaco Extrahospitalario , Humanos , Paro Cardíaco Extrahospitalario/terapia , Paro Cardíaco Extrahospitalario/mortalidad , Reanimación Cardiopulmonar/métodos , Reanimación Cardiopulmonar/normas , Oxigenación por Membrana Extracorpórea/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Resultado del Tratamiento
6.
Resusc Plus ; 18: 100657, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38778803

RESUMEN

Introduction: Extracorporeal cardiopulmonary resuscitation (ECPR) is increasingly used as a supportive treatment for refractory out-of-hospital cardiac arrest (OHCA). Still, there is a paucity of data evaluating favorable and unfavorable prognostic characteristics in patients considered for ECPR. Methods: We performed a previously unplanned post-hoc analysis of the multicenter randomized controlled INCEPTION-trial. The study group consisted of patients receiving ECPR, irrespective of initial group randomization. The patients were divided into favorable survivors (cerebral performance category [CPC] 1-2) and unfavorable or non-survivors (CPC 3-5). Results: In the initial INCEPTION-trial, 134 patients were randomized. ECPR treatment was started in 46 (66%) of 70 patients in the ECPR treatment arm and 3 (4%) of 74 patients in the conventional treatment arm. No statistically significant differences in baseline characteristics, medical history, or causes of arrest were observed between survivors (n = 5) and non-survivors (n = 44). More patients in the surviving group had a shockable rhythm at the time of cannulation (60% vs. 14%, p = 0.037), underwent more defibrillation attempts (13 vs. 6, p = 0.002), and received higher dosages of amiodarone (450 mg vs 375 mg, p = 0.047) despite similar durations of resuscitation maneuvers. Furthermore, non-survivors more frequently had post-ECPR implantation adverse events. Conclusion: The persistence of ventricular arrhythmia is a favorable prognostic factor in patients with refractory OHCA undergoing an ECPR-based treatment. Future studies are warranted to confirm this finding and to establish additional prognostic factors.Clinical trial Registration:clinicaltrials.gov registration number NCT03101787.

7.
Artículo en Inglés | MEDLINE | ID: mdl-38521547

RESUMEN

OBJECTIVES: The aim of surgical treatment of mitral valve disease is to reverse heart failure and to restore life expectancy and quality of life (QoL). In mitral valve surgery, QoL has not been studied extensively, especially regarding the surgical approach. The current study aimed to evaluate QoL after mitral valve surgery through full sternotomy and a minimally invasive approach (MIMVS). METHODS: All patients undergoing mitral valve surgery between 2013-2018 through sternotomy or a MIMVS approach (right anterolateral mini-thoracotomy, sternal-sparing), with or without concomitant tricuspid valve surgery, surgical ablation, or atrial septal defect closure were eligible for inclusion in this multicentre nationwide registry in the Netherlands. Quality of life was measured using the 12- and 36-item short form surveys, before surgery and postoperatively at 1 year. Independent predictors for loss of QoL were evaluated. RESULTS: 485 patients were included (full sternotomy: n = 276, and MIMVS: n = 209). Overall, patients experienced a significant increase in physical component score (56 [42-75] vs 74 [57-88], p < 0.001) and mental component score at 1-year (63 [52-74] vs 70 [59-86], p < 0.001). Baseline QoL scores and new onset of atrial arrhythmia were independently associated with a clinically relevant reduction in physical and mental QoL. CONCLUSIONS: Mitral valve surgery is associated with significant improvement in physical and mental QoL. Baseline QoL scores and new onset of atrial arrhythmia are associated with a clinically relevant reduction in postoperative QoL.

9.
Ann Cardiothorac Surg ; 13(1): 54-70, 2024 Jan 30.
Artículo en Inglés | MEDLINE | ID: mdl-38380145

RESUMEN

In this state-of-the art review on hybrid atrial fibrillation (AF) ablation, we briefly focus on the pathophysiology of AF, the rationale for the hybrid approach, its technical aspects and the efficacy and safety outcomes after hybrid AF ablation, both from meta-analyses and randomized control trial data. Also, we performed a systematic search to provide a provisional overview of real-world hybrid AF ablation efficacy and safety outcomes. Furthermore, we give an insight into the 'Maastricht approach', an approach that allows us to tailor the ablation procedure to the individual patient. Finally, we reflect on future perspectives with the objective to continue improving our thoracoscopic hybrid AF ablation approach. Based on the review of the available literature, we believe it is fair to state that thoracoscopic hybrid AF ablation is a valid alternative to catheter ablation for the treatment of patients with more persistent forms of AF.

10.
Clin Nutr ESPEN ; 59: 162-170, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38220371

RESUMEN

BACKGROUND: The PRECISe trial is a pragmatic, multicenter randomized controlled trial that evaluates the effect of high versus standard enteral protein provision on functional recovery in adult, mechanically ventilated critically ill patients. The current protocol presents the rationale and analysis plan for an evaluation of the primary and secondary outcomes under the Bayesian framework, with an emphasis on clinically important effect sizes. METHODS: This protocol was drafted in agreement with the ROBUST-statement, and is submitted for publication before database lock and primary data analysis. The primary outcome is health-related quality of life as measured by the EQ-5D-5L health utility score and is longitudinally assessed. Secondary outcomes comprise the 6-min walking test and handgrip strength over the entire follow-up period (longitudinal analyses), and 60-day mortality, duration of mechanical ventilation, and EQ-5D-5L health utility scores at 30, 90 and 180 days (cross-sectional). All analyses will primarily be performed under weakly informative priors. When available, informative priors elicited from contemporary literature will also be incorporated under alternative scenarios. In all other cases, objectively formulated skeptical and enthusiastic priors will be defined to assess the robustness of our results. Relevant identified subgroups were: patients with acute kidney injury, severe multi-organ failure and patients with or without sepsis. Results will be presented as absolute risk differences, mean differences, and odds ratios, with accompanying 95% credible intervals. Posterior probabilities will be estimated for clinically important benefit and harm. DISCUSSION: The proposed secondary, pre-planned Bayesian analysis of the PRECISe trial will provide additional information on the effects of high protein on functional and clinical outcomes in critically ill patients, such as probabilistic interpretation, probabilities of clinically important effect sizes, and the integration of prior evidence. As such, it will complement the interpretation of the primary outcome as well as several secondary and subgroup analyses.


Asunto(s)
Enfermedad Crítica , Calidad de Vida , Adulto , Humanos , Teorema de Bayes , Enfermedad Crítica/terapia , Fuerza de la Mano , Estudios Transversales , Cuidados Críticos/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto
11.
Resuscitation ; 194: 110033, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37923112

RESUMEN

BACKGROUND: Evidence for extracorporeal cardiopulmonary resuscitation (CPR) in refractory out-of-hospital cardiac arrest (OHCA) remains inconclusive. Recently, the INCEPTION-trial, comparing extracorporeal with conventional CPR, found no statistically significant difference in neurologically favorable survival. Since protocol deviations were anticipated, a pre-specified per-protocol analysis was foreseen. METHODS: The per-protocol analysis of the INCEPTION trial excluded patients not meeting inclusion or exclusion criteria, amongst which time-to-cannulation of >60 minutes, and achieving a return of spontaneous circulation before hospital arrival. Crossovers were excluded as well. The primary outcome (30-day survival in a neurologically favorable condition; cerebral performance category [CPC] 1-2) was primarily analyzed under a frequentist statistical framework. In addition, Bayesian analysis under a minimally informative prior was performed. RESULTS: Eighty-one patients were included in the per-protocol analysis (extracorporeal CPR n = 33, conventional CPR n = 48). Thirty-day survival with CPC1-2 was 15% in the extracorporeal CPR group versus 9% in the conventional CPR group (adjusted OR 1.9; 95% CI 0.4-9.3; p-value 0.393). Bayesian analysis showed an 84% posterior probability of any ECPR benefit and a 61% posterior probability of a 5% absolute risk reduction for the primary outcome. CONCLUSION: A pre-planned, pre-specified per-protocol analysis of the INCEPTION-trial, found a higher survival with favorable neurological in patients undergoing ECPR versus CCPR for refractory shockable OHCA. This difference did not reach statistical significance, but results should be interpreted with care, in the light of the small remaining sample size.


Asunto(s)
Reanimación Cardiopulmonar , Paro Cardíaco Extrahospitalario , Humanos , Paro Cardíaco Extrahospitalario/terapia , Reanimación Cardiopulmonar/métodos , Teorema de Bayes , Factores de Tiempo , Probabilidad
12.
Eur Heart J Acute Cardiovasc Care ; 13(2): 191-200, 2024 Feb 16.
Artículo en Inglés | MEDLINE | ID: mdl-37872725

RESUMEN

AIMS: Previously, we performed the multicentre INCEPTION trial, randomizing patients with refractory out-of-hospital cardiac arrest (OHCA) to extracorporeal cardiopulmonary resuscitation (ECPR) or conventional cardiopulmonary resuscitation (CCPR). Frequentist analysis showed no statistically significant treatment effect for the primary outcome; 30-day survival with a favourable neurologic outcome (cerebral performance category score of 1-2). To facilitate a probabilistic interpretation of the results, we present a Bayesian re-analysis of the INCEPTION trial. METHODS AND RESULTS: We analysed survival with a favourable neurologic outcome at 30 days and 6 months under a minimally informative prior in the intention-to-treat population. Effect sizes are presented as absolute risk differences (ARDs) and relative risks (RRs), with 95% credible intervals (CrIs). We estimated posterior probabilities at various thresholds, including the minimal clinically important difference (MCID) (5% ARD), based on expert consensus, and performed sensitivity analyses under sceptical and literature-based priors. The mean ARD for 30-day survival with a favourable neurologic outcome was 3.6% (95% CrI -9.5-16.7%), favouring ECPR, with a median RR of 1.22 (95% CrI 0.59-2.51). The posterior probability of an MCID was 42% at 30 days and 42% at 6 months, in favour of ECPR. CONCLUSION: Bayesian re-analysis of the INCEPTION trial estimated a 42% probability of an MCID between ECPR and CCPR in refractory OHCA in terms of 30-day survival with a favourable neurologic outcome. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03101787, registered 5 April 2017).


Asunto(s)
Reanimación Cardiopulmonar , Oxigenación por Membrana Extracorpórea , Paro Cardíaco Extrahospitalario , Humanos , Teorema de Bayes , Oxigenación por Membrana Extracorpórea/métodos , Reanimación Cardiopulmonar/métodos , Paro Cardíaco Extrahospitalario/terapia , Probabilidad , Estudios Retrospectivos
13.
Artículo en Inglés | MEDLINE | ID: mdl-37982737

RESUMEN

OBJECTIVES: The concept of non-inferiority is widely adopted in randomized trials comparing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). However, uncertainty exists regarding the long-term outcomes of TAVR, and non-inferiority may be difficult to assess. We performed a systematic review and meta-analysis of randomized trials comparing TAVR and SAVR, with a specific emphasis on the non-inferiority margin for 5-year all-cause mortality. METHODS: A systematic search was applied to 3 electronic databases. Randomized trials comparing TAVR and SAVR were included. Bayesian methods were implemented to evaluate the posterior probability of non-inferiority at different trial non-inferiority margins under either a vague, Cauchy, or a literature-based prior. Primary outcomes were 5-year actuarial all-cause mortality, and the probability of non-inferiority at various transformed trial non-inferiority margins. Secondary outcomes were long-term survival and 1- and 2-year actuarial survival. RESULTS: Eight trials (n = 8698 patients) were included. Kaplan-Meier-derived 5-year survival was 61.6% (95% CI 59.8-63.5%) for TAVR, and 63.7% (95% CI 61.9-65.6%) for SAVR. Six trials (n = 6370 patients) reported all-cause mortality at 5-year follow-up. Under a vague prior, the posterior median relative risk for all-cause mortality of TAVR was 1.14, compared to SAVR (95% credible interval 1.06-1.22, probability of relative risk <1.00 = 0.01%, I2 = 0%). Similar results in terms of point estimate and uncertainty measures were obtained using frequentist methods. Based on the various trial non-inferiority margins, the results of the analysis suggest that non-inferiority at 5 years is no longer likely. CONCLUSIONS: It is unlikely that TAVR is still non-inferior to SAVR at 5 years in terms of all-cause mortality.

14.
Heart ; 2023 Nov 23.
Artículo en Inglés | MEDLINE | ID: mdl-37996242

RESUMEN

OBJECTIVES: The use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis of randomised CEP trials, focusing on a clinically relevant reduction in disabling stroke. METHODS: A systematic search was applied to three electronic databases, including trials that randomised TAVI patients to CEP versus standard treatment. The primary outcome was the risk of disabling stroke. Outcomes were presented as relative risk (RR), absolute risk differences (ARDs), numbers needed to treat (NNTs) and the 95% credible intervals (CrIs). The minimal clinically important difference was determined at 1.1% ARD, per expert consensus (NNT 91). The principal Bayesian meta-analysis was performed under a vague prior, and secondary analyses were performed under two informed literature-based priors. RESULTS: Seven randomised studies were included for meta-analysis (n=3996: CEP n=2126, control n=1870). Under a vague prior, the estimated median RR of CEP use for disabling stroke was 0.56 (95% CrI 0.28 to 1.19, derived ARD 0.56% and NNT 179, I2=0%). Although the estimated posterior probability of any benefit was 94.4%, the probability of a clinically relevant effect was 0-0.1% under the vague and informed literature-based priors. Results were robust across multiple sensitivity analyses. CONCLUSION: There is a high probability of a beneficial CEP treatment effect, but this is unlikely to be clinically relevant. These findings suggest that future trials should focus on identifying TAVI patients with an increased baseline risk of stroke, and on the development of new generation devices. PROSPERO REGISTRATION NUMBER: CRD42023407006.

16.
Eur J Cardiothorac Surg ; 64(4)2023 10 04.
Artículo en Inglés | MEDLINE | ID: mdl-37812245

RESUMEN

OBJECTIVES: Literature is scarce on the management of patients using direct oral anticoagulants (DOACs) undergoing elective, urgent and emergency surgery. Therefore, we summarize the current evidence and provide literature-based recommendations for the management of patients on DOACs in the perioperative phase. METHODS: A general literature review was conducted on the pharmacology of DOACs and for recommendations on the management of cardiac surgical patients on DOACs. Additionally, we performed a systematic review for studies on the use of direct DOAC reversal agents in the emergency cardiac surgical setting. RESULTS: When surgery is elective, the DOAC cessation strategy is relatively straightforward and should be adapted to the renal function. The same approach applies to urgent cases, but additional DOAC activity drug level monitoring tests may be useful. In emergency cases, idarucizumab can be safely administered to patients on dabigatran in any of the perioperative phases. However, andexanet alfa, which is not registered for perioperative use, should not be administered in the preoperative phase to reverse the effect of factor Xa inhibitors, as it may induce temporary heparin resistance. Finally, the administration of (activated) prothrombin complex concentrate may be considered in all patients on DOACs, and such concentrates are generally readily available. CONCLUSIONS: DOACs offer several advantages over vitamin K antagonists, but care must be taken in patients undergoing cardiac surgery. Although elective and urgent cases can be managed relatively straightforwardly, the management of emergency cases requires particular attention.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Hemorragia , Humanos , Administración Oral , Anticoagulantes/uso terapéutico , Dabigatrán/uso terapéutico , Heparina
17.
J Am Coll Cardiol ; 82(13): 1301-1312, 2023 09 26.
Artículo en Inglés | MEDLINE | ID: mdl-37730286

RESUMEN

BACKGROUND: The relevance of perioperative myocardial injury (PMI) after cardiac surgery for 30-day mortality and long-term survival remains to be determined. OBJECTIVES: This study assessed the association of PMI after cardiac surgery, reflected by postoperative troponin release, with 30-day mortality and long-term survival after: 1) coronary artery bypass grafting (CABG); 2) isolated aortic valve replacement (AVR) surgery; and 3) all other cardiac surgeries. METHODS: A consecutive cohort of 8,292 patients undergoing cardiac surgery with serial perioperative high-sensitivity cardiac troponin T (hs-cTnT) measurements was retrospectively analyzed. The relationship between postoperative hs-cTnT release and 30-day mortality or 5-year mortality was analyzed after adjustment with EuroSCORE II using a Cox proportional hazards model. hs-cTnT thresholds for 30-day and 5-year mortality were determined for isolated CABG (32.3%), AVR (14%), and other cardiac surgery (53.8%). RESULTS: High postoperative hs-cTnT levels were associated with higher 30-day mortality but not 5-year mortality. In CABG, median peak concentration of postoperative hs-cTnT was 1,044 ng/L, in AVR it was 502 ng/L, and in other cardiac surgery it was 1,110 ng/L. hs-cTnT thresholds defining mortality-associated PMI were as follows: for CABG, 2,385 ng/L (170× the upper reference limit of normal in a seemingly healthy population [URL]); for AVR, 568 ng/L (41× URL); and for other cardiac procedures, 1,873 ng/L (134× URL). hs-cTnT levels above the cutoffs resulted in an HR for 30-day mortality for CABG of 12.56 (P < 0.001), for AVR of 4.44 (P = 0.004), and for other cardiac surgery of 3.97 (P < 0.001). CONCLUSIONS: PMI reflected by perioperative hs-cTnT release is associated with the expected 30-day mortality but not 5-year mortality. Postoperative hs-cTnT cutoffs to identify survival-relevant PMI are higher than suggested in current definitions.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Lesiones Cardíacas , Humanos , Troponina T , Estudios Retrospectivos , Puente de Arteria Coronaria/efectos adversos , Miocardio
18.
Eur Heart J ; 44(41): 4357-4372, 2023 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-37638786

RESUMEN

BACKGROUND AND AIMS: The current study proposes a novel volume-outcome (V-O) meta-analytical approach to determine the optimal annual hospital case volume threshold for cardiovascular interventions in need of centralization. This novel method is applied to surgery for acute type A aortic dissection (ATAAD) as an illustrative example. METHODS: A systematic search was applied to three electronic databases (1 January 2012 to 29 March 2023). The primary outcome was early mortality in relation to annual hospital case volume. Data were presented by volume quartiles (Qs). Restricted cubic splines were used to demonstrate the V-O relation, and the elbow method was applied to determine the optimal case volume. For clinical interpretation, numbers needed to treat (NNTs) were calculated. RESULTS: One hundred and forty studies were included, comprising 38 276 patients. A significant non-linear V-O effect was observed (P < .001), with a notable between-quartile difference in early mortality rate [10.3% (Q4) vs. 16.2% (Q1)]. The optimal annual case volume was determined at 38 cases/year [95% confidence interval (CI) 37-40 cases/year, NNT to save a life in a centre with the optimal volume vs. 10 cases/year = 21]. More pronounced between-quartile survival differences were observed for long-term survival [10-year survival (Q4) 69% vs. (Q1) 51%, P < .01, adjusted hazard ratio 0.83, 95% CI 0.75-0.91 per quartile, NNT to save a life in a high-volume (Q4) vs. low-volume centre (Q1) = 6]. CONCLUSIONS: Using this novel approach, the optimal hospital case volume threshold was statistically determined. Centralization of ATAAD care to high-volume centres may lead to improved outcomes. This method can be applied to various other cardiovascular procedures requiring centralization.


Asunto(s)
Disección Aórtica , Hospitales de Alto Volumen , Humanos , Resultado del Tratamiento , Disección Aórtica/cirugía , Estudios Retrospectivos
20.
Eur Heart J Acute Cardiovasc Care ; 12(8): 540-547, 2023 Aug 24.
Artículo en Inglés | MEDLINE | ID: mdl-37480551

RESUMEN

Extracorporeal cardiopulmonary resuscitation is a promising treatment for refractory out-of-hospital cardiac arrest. Three recent randomized trials (ARREST trial, Prague OHCA study, and INCEPTION trial) that addressed the clinical benefit of extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest yielded seemingly diverging results. The evidence for extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest, derived from three recent randomized controlled trials, is not contradictory but rather complementary. Excellent results can be achieved with a very high level of dedication, provided that strict selection criteria are applied. However, pragmatic implementation of extracorporeal cardiopulmonary resuscitation does not necessarily lead to improved outcome of refractory out-of-hospital cardiac arrest. Centres that are performing extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest or aspire to do so should critically evaluate whether they are able to meet the pre-requisites that are needed to conduct an effective extracorporeal cardiopulmonary resuscitation programme.


Asunto(s)
Reanimación Cardiopulmonar , Paro Cardíaco Extrahospitalario , Humanos , Paro Cardíaco Extrahospitalario/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto
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