Aortic valve Replacement compared to Transcatheter Implant and its relationship with COgnitive Impairment (ARTICO) evaluated with neuropsychological and advanced neuroimaging: a longitudinal cohort study.

BACKGROUND: Aortic stenosis is the most common valvulopathy in Western countries. The treatment of choice had been surgery aortic valve replacement (SAVR), but the improvement in endovascular approaches as transcatheter aortic valve implantation (TAVI), initially reserved for patients with very high surgical risk, has been extended to high and intermediate, and recently also to low-risk patients. Stroke and vascular cognitive impairment are the most important complications. It is not entirely clear which technique is best to avoid these complications as well as their impact. Our goal is to evaluate changes in cognitive performance in the early (1-month) and late (1-year) postoperative period in patients undergoing SAVR or TAVI, by extensive neuropsychological study (NRP) and advanced Magnetic Resonance Imaging (MRI). Specifically, to compare early and late cognitive changes after the intervention between both groups, the occurrence of stroke during follow-up and to compare the appearance of silent vascular lesions and changes in brain activity and functional connectivity with functional MRI during follow-up between both groups. METHODS/DESIGN: Prospective longitudinal cohort study. A non-selected representative sample of 80 subjects, 40 SAVR and 40 TAVI to obtain a final sample of 36 eligible subjects in each group, ranging from 70 to 85 years old, with indication for aortic replacement and intermediate or high surgical risk will be studied. At baseline, within one month before the treatment, all individuals will undergo an extensive NRP and advanced MRI study. These studies will also be performed 1-month and 1-year after treatment, to assess the appearance of new vascular lesions, as well as changes in cognitive performance with respect to baseline. DISCUSSION: This study aims to evaluate changes in cognitive performance as well as both clinical and silent vascular events occurring in the early (1-month) and late (1-year) periods after SAVR and TAVI. We will also analyze the correlation between neuropsychological and neuroimaging approaches in order to evaluate cognition. Therefore, it may provide high-quality data of cognitive changes and vascular events for both techniques, and be useful to tailor interventions to individual characteristics and ultimately aiding in decision-making. TRIAL REGISTRATION: This study is register in Clinicaltrials.gov (NCT05235529) on 11th February 2022.

Esperanza de vida después del recambio valvular debido a estenosis aórtica de bajo gradiente con función ventricular conservada / Life expectancy after surgical aortic valve replacement for low-gradient aortic stenosis with preserved ejection fraction

Introducción y objetivos: El recambio valvular aórtico (RVAo) quirúrgico puede modificar la historia natural de la estenosis aórtica grave (EAoG). Sin embargo, comparado con la población general, estos pacientes tienen una pérdida en su esperanza de vida. La esperanza de vida de los pacientes intervenidos de RVAo debido a EAoG de bajo gradiente con fracción de eyección del ventrículo izquierdo (FEVI) conservada se desconoce. Métodos: Se incluyó a todos los pacientes entre 50 y 65 años sometidos a RVAo quirúrgico aislado en 27 centros durante 18 años. Analizamos la supervivencia observada y esperada a los 18 años de pacientes con EAoG de bajo gradiente con FEVI conservada y todos los otros tipos de EAoG. Mediante emparejamiento basado en índice de propensión, comparamos la esperanza de vida de los pacientes con EAoG de bajo gradiente con FEVI conservada vs EAoG de alto gradiente con FEVI conservada. Resultados: Se analizó a 5.084 pacientes, 413 con EAoG de bajo gradiente con FEVI conservada. En estos pacientes, la supervivencia observada a 10, 15 y 18 años fue 86,6% (IC95%, 85,3-87,8), 75% (IC95%, 72,7-77,2) y 63,5% (IC95%, 58,8-67,8). La supervivencia esperada a 10, 15 y 18 años fue 90,2%, 82,1% y 75,7%. En la muestra emparejada, la supervivencia de los pacientes con EAoG de bajo gradiente con FEVI conservada fue similar a la de aquellos con EAoG de alto gradiente con FEVI conservada, test de log-rank p=0,95, HR=1 (IC95%, 0,7–1,4; p=0,95). Conclusiones: Existe una pérdida en la esperanza de vida en todos los tipos de EAoG después del RVAo. Esta pérdida es mayor en los pacientes con disfunción ventricular y menor en los pacientes con EAoG de bajo gradiente o alto gradiente con FEVI conservada. El beneficio de la cirugía es similar entre estos 2 últimos grupos.(AU)

Introduction and objectives: Surgical aortic valve replacement (SAVR) can modify the natural history of severe aortic stenosis (SAS). However, compared with the general population, these patients have a loss of life expectancy. The life expectancy of patients who undergo SAVR due to low-gradient SAS with preserved left ventricular ejection fraction (LVEF) is unknown. Methods: We included all patients between 50 and 65 years who underwent isolated SAVR in 27 Spanish centers during an 18-year period. We analyzed observed and expected survival at 18 years in patients with low-gradient SAS with preserved LVEF and all other types of SAS. We used propensity score matching to compare the life expectancy of patients with low-gradient SAS with preserved LVEF vs those with high-gradient SAS with preserved LVEF. Results: We analyzed 5084 patients, of whom 413 had low-gradient SAS with preserved LVEF. For these patients, observed survival at 10, 15 and 18 years was 86.6% (95%CI, 85.3-87.8), 75% (95%CI, 72.7-77.2), and 63.5% (95%CI, 58.8-67.8). Expected survival at 10, 15 and 18 years was 90.2%, 82.1%, and 75.7%. In the matched sample, survival of patients with low-gradient SAS with preserved LVEF was similar to that of patients with high-gradient with preserved LVEF, log-rank test, P=.95; HR=1 (95%CI, 0.7–1.4; P=.95). Conclusions: There is a loss of life expectancy in patients with all types of SAS undergoing SAVR. This loss is higher in patients with left ventricular dysfunction and lower in patients with low-gradient or high-gradient aortic stenosis with preserved LVEF. The benefit of surgery is similar between these last 2 groups.(AU)

Biological versus mechanical prostheses for aortic valve replacement.

OBJECTIVES: Long-term real-world outcomes are critical for informing decisions about biological (Bio) or mechanical (Mech) prostheses for aortic valve replacement, particularly in patients aged between 50 and 65 years. The objective was to compare long-term survival and major adverse cardiac and cardiovascular events (ie, stroke, reoperation, and major bleeding) within this population. METHODS: This was a multicenter observational study including all patients aged between 50 and 65 years who underwent an aortic valve replacement because of severe isolated aortic stenosis between the years 2000 and 2018. A total of 5215 patients from 27 Spanish hospitals were registered with a follow-up of 15 years. Multivariable analyses, including a 2:1 propensity score matching (1822 Mech and 911 Bio) and competing risks analyses were applied. RESULTS: Bio prostheses were implanted in 19% of patients (n = 992). No significant differences were observed between matched groups in long-term survival (hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.88-1.47; P = .33). Stroke rates were higher for Mech prostheses, but not significant (HR, 0.72; 95% CI, 0.50-1.03; P = .07). Finally, higher rates of major bleeding were found in the Mech group (HR, 0.65; 95% CI, 0.49-0.87; P = .004), whereas reoperation was more frequent among the Bio group (HR, 3.04; 95% CI, 1.80-5.14; P < .001). Bio prostheses increased from 13% in the period from 2000 to 2008 to 24% in 2009 to 2018. CONCLUSIONS: Long-term survival was comparable among groups in patients between 50 and 65 years of age. Mech prostheses were associated with a higher risk of major bleeding, whereas Bio prostheses entailed higher reoperation rates. Bio prostheses seem a reasonable choice for patients between 50 and 65 years in Spain.

Life expectancy after surgical aortic valve replacement for low-gradient aortic stenosis with preserved ejection fraction.

INTRODUCTION AND OBJECTIVES: Surgical aortic valve replacement (SAVR) can modify the natural history of severe aortic stenosis (SAS). However, compared with the general population, these patients have a loss of life expectancy. The life expectancy of patients who undergo SAVR due to low-gradient SAS with preserved left ventricular ejection fraction (LVEF) is unknown. METHODS: We included all patients between 50 and 65 years who underwent isolated SAVR in 27 Spanish centers during an 18-year period. We analyzed observed and expected survival at 18 years in patients with low-gradient SAS with preserved LVEF and all other types of SAS. We used propensity score matching to compare the life expectancy of patients with low-gradient SAS with preserved LVEF vs those with high-gradient SAS with preserved LVEF. RESULTS: We analyzed 5084 patients, of whom 413 had low-gradient SAS with preserved LVEF. For these patients, observed survival at 10, 15 and 18 years was 86.6% (95%CI, 85.3-87.8), 75% (95%CI, 72.7-77.2), and 63.5% (95%CI, 58.8-67.8). Expected survival at 10, 15 and 18 years was 90.2%, 82.1%, and 75.7%. In the matched sample, survival of patients with low-gradient SAS with preserved LVEF was similar to that of patients with high-gradient with preserved LVEF, log-rank test, P=.95; HR=1 (95%CI, 0.7-1.4; P=.95). CONCLUSIONS: There is a loss of life expectancy in patients with all types of SAS undergoing SAVR. This loss is higher in patients with left ventricular dysfunction and lower in patients with low-gradient or high-gradient aortic stenosis with preserved LVEF. The benefit of surgery is similar between these last 2 groups.

Mechanical complications in STEMI: prevalence and mortality trends in the primary PCI era. The Ruti-STEMI registry.

INTRODUCTION AND OBJECTIVES: Mechanical complications confer a dreadful prognosis in ST-elevation myocardial infarction (STEMI). Their prevalence and prognosis are not well-defined in the current era of primary percutaneous coronary intervention (pPCI) reperfusion networks. We aimed to analyze prevalence and mortality trends of post-STEMI mechanical complications over 2 decades, before and after the establishment of pPCI networks. METHODS: Prospective, consecutive registry of STEMI patients within a region of 850 000 inhabitants over 2 decades: a pre-pPCI period (1990-2000) and a pPCI period (2007-2017). We analyzed the prevalence of mechanical complications, including ventricular septal rupture, papillary muscle rupture, and free wall rupture (FWR). Twenty eight-day and 1-year mortality trends were compared between the 2 studied decades. RESULTS: A total of 6033 STEMI patients were included (pre-pPCI period, n=2250; pPCI period, n=3783). Reperfusion was supported by thrombolysis in the pre-pPCI period (99.1%) and by pPCI in in the pPCI period (95.7%). Mechanical complications developed in 135 patients (2.2%): ventricular septal rupture in 38 patients, papillary muscle rupture in 24, and FWR in 73 patients. FWR showed a relative reduction of 60% in the pPCI period (0.8% vs 2.0%, P<.001), without significant interperiod changes in the other mechanical complications. After multivariate adjustment, FWR remained higher in the pre-pPCI period (OR, 1.93; 95%CI, 1.10-3.41; P=.023). At 28 days and 1 year, mortality showed no significant changes in all the mechanical complications studied. CONCLUSIONS: The establishment of regional pPCI networks has modified the landscape of mechanical complications in STEMI. FWR is less frequent in the pPCI era, likely due to reduced transmural infarcts.

Long-term outcomes with the On-X bileaflet mitral valve: clinical events up to 17 years in 661 patients.

OBJECTIVES: This study reports long-term clinical outcomes-up to 17 years-among patients undergoing mitral valve replacement with the On-X bileaflet mechanical valve. Prior data regarding long-term outcomes with the On-X mitral valve have been limited. METHODS: This retrospective observational study included all patients who underwent mitral valve replacement with the On-X (Standard or Conform-X) valve at 2 major Spanish cardiac surgery centres between 2001 and 2018. The primary study end point was freedom from death. The secondary study end points included surgical mortality and freedom from any valve-related events. Data were obtained from an institutional database, medical records review, direct telephone interviews or the Spanish population registry. Statistical and Kaplan-Meier analyses were performed. RESULTS: A total of 661 patients (mean age 63.1 ± 10.9 years, 63% female) were followed for a mean of 5.6 years (range, 0-17.4 years). Survival at 5, 10 and 15 years was 85%, 71% and 63%, respectively. Surgical mortality was 7.3% (48/661). The linearized rate of global mortality was 1.3% patient-year. Freedom from reoperation was 97%, 95% and 92% at 5, 10 and 15 years, respectively; freedom from anticoagulation-related events was 94%, 89% and 89%, respectively. Multivariable analysis showed that mortality increased with total length of stay, age, smoking history, severe pulmonary hypertension and a permanent pacemaker. Patients who received the On-X 25 -mm valve had decreased long-term survival relative to patients who received other On-X valve sizes, possibly due to underlying risk factors. CONCLUSIONS: Patients in this study showed good long-term survival and freedom from valve-related events.

Life expectancy after aortic valve replacement in young patients.

INTRODUCTION AND OBJECTIVES: In young patients with severe aortic stenosis, it is unknown whether their life expectancy restored after aortic valve replacement (AVR) is unknown. METHODS: We analyzed all patients aged between 50 and 65 years who underwent isolated AVR in 27 Spanish centers during an 18-year period. We compared observed and expected survival at 15 years of follow-up. We repeated all analyses for patients without complications in the postoperative period. RESULTS: A total of 5084 patients were analyzed. For the overall sample, observed survival at 10 and 15 years was 85.3% (95%CI, 84.1%-86.4%) and 73.7% (95%CI, 71.6%-75.6%), respectively. Expected survival was 90.1% and 82.1%. Cumulative relative survival for 1, 5, 10 and 15 years of follow-up was 97.4% (95%CI, 96.9%-97.9%), 96.5% (95%CI, 95.7%-97.3%), 94.7% (95%CI, 93.3%-95.9%), and 89.8% (95%CI, 87.3%-92.1%). For patients without complications, cumulative relative survival for 1, 5, 10 and 15 years was 100.3% (95%CI, 99.8%-100.5%), 98.9% (95%CI 97.6% -99.9%), 97.3% (95%CI, 94.9%-99.4%), and 91.9% (95%CI, 86.5%-96.8%). CONCLUSIONS: Life expectancy in young patients who have severe aortic stenosis and undergo AVR is lower than that of the general population. Life expectancy of individuals without complications during the postoperative period is also reduced. Therefore, baseline characteristics are likely the main factors that explain the reduction in life expectancy.

Differences in life expectancy between men and women after aortic valve replacement.

OBJECTIVES: Some researchers have observed an increased number of deaths during the follow-up of young patients who undergo aortic valve replacement due to severe aortic stenosis, suggesting that this procedure does not restore their life expectancy. Our goal was to confirm these findings and explore sex-based differences. METHODS: All patients between 50 and 65 years of age who underwent isolated aortic valve replacement in 27 Spanish centres during an 18-year period were included. We compared observed and expected survival at 15 years of follow-up and estimated the cumulative incidence of death from a competing risks point of view. We stratified by sex and analysed if being a woman was an independent risk factor for death. RESULTS: For men, the observed survival at 10 and 15 years of follow-up was 85% [95% confidence interval (CI) 83.6%-86.4%] and 72.3% (95% CI 69.7%-74.7%), respectively whereas the expected survival was 88.1% and 78.8%. For women, the observed survival at 10 and 15 years was 85% (95% CI 82.8%-86.9%) and 73% (95% CI 69.1%-76.4%), whereas the expected survival was 94.6% and 89.4%. At 15 years of follow-up, the cumulative incidence of death due to the disease in men and women was 8.2% and 16.7%, respectively. In addition, being a woman was an independent risk factor for death (hazard ratio = 1.23 (95% CI 1.02-1.48; P = 0.03). CONCLUSIONS: After the aortic valve replacement, men and women do not have their life expectancy restored, but this loss is much higher in women than in men. In addition, being a woman is a risk factor for long-term death. Reasons for these findings are unknown and must be investigated.

Thromboembolism and bleeding in patients with cancer and mechanical heart valves.

Mechanical heart valves (MHV) require life-long anticoagulation with vitamin K antagonists (VKA), but anticoagulation management is complex in patients with cancer due to a high risk of thrombosis and bleeding. This is a retrospective, single-center study to assess anticoagulation management and thrombotic (stroke/valve thrombosis) and bleeding events in patients with active cancer and MHV. The incidence of thrombotic complications was compared to a control group (matched 1:1) of patients with MHV but without cancer. We included 48 patients, 60% of whom had aortic prostheses, 23% mitral prostheses and 17% both types. All patients received VKA as anticoagulant. With a median follow-up of 5.12 years, we observed two arterial thrombotic events (two strokes and no heart valve thrombosis). The 5-year incidence (95% confidence interval [CI]) of stroke/valve thrombosis was 5.7% (0.9-17.9%). The control group had a similar incidence of stroke/valve thrombosis (5-year incidence 7.9% [95%CI 2-19.8], p = 0.16). There were also 15 major bleeding episodes in the cancer group, 11 of which were related to a surgical procedure. The 5-year incidence (95% CI) of major bleeding was 32.9% (18.5-48%), and that of major bleeding unrelated to any procedure was 10.3% (3-23%). We found a low incidence of thrombotic events in this series of patients with active cancer and MHV who were anticoagulated with VKA. However, the incidence of bleeding was high, particularly in relation to invasive procedures.

Unidad de cuidados intermedios tras la cirugía cardiaca: impacto en la estancia media y la evolución clínica / Intermediate care unit after cardiac surgery: impact on length of stay and outcomes

Introducción y objetivos: El posoperatorio de cirugía cardiaca incluye el traslado desde la unidad de cuidados intensivos (UCI) a la sala convencional. Las unidades de cuidados intermedios (UCIn) permiten la optimización de recursos hospitalarios. Se ha analizado el impacto de una UCIn en las estancias medias (en la UCI y hospitalaria) y los resultados (mortalidad hospitalaria y reingresos a los 30 días) tras la cirugía cardiaca (UCIn-CC). Métodos: Desde noviembre de 2012 hasta abril de 2015, ingresaron para cirugía cardiaca 1.324 pacientes consecutivos. Se implementó una UCIn-CC (mayo de 2014). Los pacientes se clasificaron en 2 grupos: pre-UCIn-CC (noviembre de 2012 a abril de 2014; n = 674) y post-UCIn-CC (mayo de 2014 a abril de 2015; n = 650). Resultados: No se observaron diferencias significativas en edad, sexo, factores de riesgo, EuroSCORE 2, fracción de eyección o tipo de cirugía (el 53% valvular, el 26% coronaria, el 11,5% valvular y coronaria y el 1,8% de aorta). La estancia en la UCI disminuyó del pre-UCIn-CC al post-UCIn-CC una media ± desviación estándar de 4,9 ± 11 a 2,9 ± 6 días (p < 0,001); de una mediana [Q1-Q3] de 2 [1-4] a 1 [0-3]; la estancia hospitalaria disminuyó de 13,5 ± 15 a 12,7 ± 11 días (p = 0,01); de 9 [7-13] a 9 [7-11]. No hubo diferencias estadísticamente significativas en la mortalidad intrahospitalaria (4,9 frente al 3,5%; p = 0,28) ni la readmisión a 30 días (4,3 frente al 4,2%; p = 0,89). Conclusiones: Tras la implementación de una UCIn-CC para el cuidado del posoperatorio de cirugía cardiaca, se observó una reducción de las estancias medias en la UCI y hospitalaria, sin que aumentaran la mortalidad hospitalaria ni los reingresos a los 30 días

Introduction and objectives: Current postoperative management of adult cardiac surgery often comprises transfer from the intensive care unit (ICU) to a conventional ward. Intermediate care units (IMCU) permit hospital resource optimization. We analyzed the impact of an IMCU on length of stay (both ICU and in-hospital) and outcomes (in-hospital mortality and 30-day readmissions) after adult cardiac surgery (IMCU-CS). Methods: From November 2012 to April 2015, 1324 consecutive patients were admitted to a university hospital for cardiac surgery. In May 2014, an IMCU-CS was established for postoperative care. For the purposes of this study, patients were classified into 2 groups, depending on the admission period: pre-IMCU-CS (November 2012-April 2014, n = 674) and post-IMCU-CS (May 2014-April 2015, n = 650). Results: There were no statistically significant differences in age, sex, risk factors, comorbidities, EuroSCORE 2, left ventricular ejection fraction, or the types of surgery (valvular in 53%, coronary in 26%, valvular plus coronary in 11.5%, and aorta in 1.8%). The ICU length of stay decreased from 4.9 ± 11 to 2.9 ± 6 days (mean ± standard deviation; P < .001); 2 [1-4] to 1 [0-3] (median [Q1-Q3]); in-hospital length of stay decreased from 13.5 ± 15 to 12.7 ± 11 days (mean ± standard deviation; P = .01); 9 [7-13] to 9 [7-11] (median [Q1-Q3]), in pre-IMCU-CS to post-IMCU-CS, respectively. There were no statistically significant differences in in-hospital mortality (4.9% vs 3.5%; P = .28) or 30-day readmission rate (4.3% vs 4.2%; P = .89). Conclusions: After the establishment of an IMCU-CS for postoperative cardiac surgery, there was a reduction in ICU and in-hospital mean lengths of stay with no increase in in-hospital mortality or 30-day readmissions

Intermediate Care Unit After Cardiac Surgery: Impact on Length of Stay and Outcomes.

INTRODUCTION AND OBJECTIVES: Current postoperative management of adult cardiac surgery often comprises transfer from the intensive care unit (ICU) to a conventional ward. Intermediate care units (IMCU) permit hospital resource optimization. We analyzed the impact of an IMCU on length of stay (both ICU and in-hospital) and outcomes (in-hospital mortality and 30-day readmissions) after adult cardiac surgery (IMCU-CS). METHODS: From November 2012 to April 2015, 1324 consecutive patients were admitted to a university hospital for cardiac surgery. In May 2014, an IMCU-CS was established for postoperative care. For the purposes of this study, patients were classified into 2 groups, depending on the admission period: pre-IMCU-CS (November 2012-April 2014, n=674) and post-IMCU-CS (May 2014-April 2015, n=650). RESULTS: There were no statistically significant differences in age, sex, risk factors, comorbidities, EuroSCORE 2, left ventricular ejection fraction, or the types of surgery (valvular in 53%, coronary in 26%, valvular plus coronary in 11.5%, and aorta in 1.8%). The ICU length of stay decreased from 4.9±11 to 2.9±6 days (mean±standard deviation; P<.001); 2 [1-4] to 1 [0-3] (median [Q1-Q3]); in-hospital length of stay decreased from 13.5±15 to 12.7±11 days (mean±standard deviation; P=.01); 9 [7-13] to 9 [7-11] (median [Q1-Q3]), in pre-IMCU-CS to post-IMCU-CS, respectively. There were no statistically significant differences in in-hospital mortality (4.9% vs 3.5%; P=.28) or 30-day readmission rate (4.3% vs 4.2%; P=.89). CONCLUSIONS: After the establishment of an IMCU-CS for postoperative cardiac surgery, there was a reduction in ICU and in-hospital mean lengths of stay with no increase in in-hospital mortality or 30-day readmissions.

Incidence and predictors of new-onset atrioventricular block requiring pacemaker implantation after sutureless aortic valve replacement.

OBJECTIVES: In high-risk patients with severe aortic stenosis, aortic valve replacement (AVR) with a sutureless Perceval prosthesis (SU-AVR) can be performed instead of conventional AVR or transcatheter aortic valve implantation. Little data are available regarding postoperative conduction disorders after SU-AVR. We aimed to determine the incidence and predictors of new-onset complete atrioventricular block (NO-AVB) requiring permanent cardiac stimulation following SU-AVR. METHODS: We studied consecutive patients who underwent SU-AVR between 2013 and 2015. Early patients underwent partial aortic decalcification and subannular valve implantation (standard technique), while later patients underwent complete/symmetrical decalcification and intra-annular valve deployment (modified technique). Predictive baseline and procedural variables and electrocardiographic parameters were identified using a logistic regression model. RESULTS: We included 140 patients (mean age, 78 ± 6.5 years; mean Log EuroSCORE II, 8.9 ± 10%; 28.6% concomitant myocardial revascularization). The most common postoperative conduction disturbances were LBBB (25%), NO-AVB (12.1%) and first-degree atrioventricular block (AVB) (7.9%). The incidence of NO-AVB was 61% lower with the modified versus the standard technique (P= 0.04). NO-AVB predominantly appeared within 24 h post-surgery, occurring >24 h post-surgery in only 2 patients (both with baseline conduction defects). Independent predictors of NO-AVB included baseline left QRS axis deviation (LaQD; P= 0.03), first-degree AVB (P< 0.01) and standard surgical technique (P= 0.02). CONCLUSIONS: NO-AVB is a frequent complication following SU-AVR, and its incidence strongly depends on the surgical technique. Baseline first-degree AVB and LaQD independently predict NO-AVB and should be considered when deciding the duration of postoperative electrocardiographic monitoring.