Rafael Vidal PérezServicio de Cardiología

Hospital Universitario Lucus Augusti@rafavidalperez

La magnitud del problema• Anualmente se estima que:

– 5,7 millones de procedimientos en Europa a pacientes con riesgo aumentado para complicaciones cardiovasculares.

– En el mundo entero, la cirugía no cardíaca se asocia con una tasa media de complicaciones totales del 7–11% y una tasa de mortalidad del 0,8–1,5%, dependiendo de las precauciones de seguridad.

– Para países de la UE: Al menos ocurren 167000 complicaciones cardíacas debido a procedimientos quirúrgicos no cardíacos, de los cuales 19000 pueden amenazar supervivencia.

Data only available at a national level in 23 European countries (41%)

Razones para unas nuevas guías de la ESC/ESA

• Alta incidencia de morbilidad y mortalidad cardíaca peri-operatoria

• Impacto de las enfermedades y comorbilidades vasculares en el resultado postoperatorio

• Impacto de estrategias de disminución del riesgo– Medicaciones: Beta-Bloqueantes, estatinas, IECA,

antiagregantes y anticoagulantes orales– Revascularización coronaria: Stents y duración de la

DAG• Cambios en las técnicas quirúrgicas• Tipo de anestesia

>115 experts have been involved including 24 Task Force members, 26 members of the Committee for Practice Guidelines, 36 National Cardiac Society reviewers, 24 expert peer reviewers, and a number of ESC and ESA Board members.279 referencias bibliográficas

CPG Coordinator

Objetivos de estas guías

• Describir como valorar el riesgo cardíaco perioperatorio empleando los factores de riesgo clínicos y el tipo de procedimiento quirúrgico

• Describir una aproximación por pasos para la valoración del riesgo cardíaco preoperatorio

• Comprender el impacto de las distintas comorbilidades sobre el riesgo perioperatorio

• Describir como reducir el riesgo cardíaco• Ser fáciles de usar por los médicos

Summary of key findings of the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography (DECREASE) series of studies:DECREASE I: In high-risk patients undergoing non-cardiac surgery, perioperative beta-blockade with bisoprolol significantly reduces cardiac death and MI in the short- and long-termDECREASE II: Patients identified as intermediate risk on the basis of a simple clinical assessment do not need pre-operative echocardiographic cardiac stress testing, provided that they receive bisoprolol to maintain resting heart rate at 60–65 b.p.m.DECREASE III: In high-risk patients undergoing major vascular surgery, fluvastatin XL significantly reduces myocardial ischaemia and the combined endpoint of cardiovascular death and MIDECREASE IV: In intermediate-risk patients, bisoprolol significantly reduces cardiac death and MI, with a non-significant trend towards a beneficial effect of fluvastatin XLDECREASE V: In high-risk patients with extensive stress-induced ischaemia, coronary revascularization (added to tight heart rate control with bisoprolol) does not produce any additional reduction in death and MI and delays surgery.

The committee found “several serious errors and protocol violations” in the DECREASE II and DECREASE VI studies and raised the possibility that the blind may have been broken in the DECREASE II, IV, and VI studies. For the DECREASE II and VI studies the committee determined that there was no independent endpoint evaluation. For DECREASE VI the committee found evidence of data fabrication in submitted abstracts for the study (the trial has not been published).

¿Qué hay de nuevo en estas guías?• Un equipo experto multidisciplinar debería ser consultado para la

evaluación preoperatoria de pacientes con enfermedad cardíaca conocida o con alto riesgo de sufrirla cuando vayan a ser sometidos a cirugía de alto riesgo no cardíaca

• La valoración del riesgo quirúrgico, que depende del tipo de procedimiento, ha sido actualizada.

• La valoración del riesgo del paciente ahora incluye no solo el score de Lee sino también otras escalas de riesgo validados tales como NSQIP y recomendaciones sobre biomarcadores (BNP & Troponinas)

• El inicio preoperatorio de beta-bloqueantes no se recomienda en todos los pacientes pero se debería considerar en los apcientes programados para cirugía de alto riesgo y que tengan factores de riesgo clínicos, o en aquellos que tengan enfermedad coronaria conocida o isquemia miocárdica

¿Qué hay de nuevo en estas guías?

• Las recomendaciones sobre el uso de aspirina e inhibidores P2Y12 en pacientes que se van a someter a cirugía no cardíaca se han actualizado.

• Se ha incluido una sección sobre el manejo de los nuevos anticoagulantes orales en pacientes que se van someter a cirugía no cardíaca.

• Se han actualizado las recomendaciones al respecto del momento de la cirugía no cardíaca tras una revascularización.

• La sección sobre enfermedades concomitantes se ha actualizado

• La sección sobre monitorización perioperatoria se ha actualizado y expandido con la ayuda de anestesistas expertos

Surgical risk estimate is a broad approximation of 30-day risk of cardiovascular death and myocardial infarction that takes into account only the specific surgical intervention, without considering the patient’s comorbidities

http://www.mdcalc.com/revised-cardiac-riskindex-for-pre-operative-risk/

Lee ScoreLee Score

To predict post-operative myocardial infarction, pulmonary oedema, ventricular fibrillation or cardiac arrest, and complete heart block

http://www.surgicalriskcalculator.com/miorcardiacarrest

NSQIPNSQIP

To assess the risk of intra-operative/post-operative myocardial infarction or cardiac arrest, using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database

Therefore, the NSQIP and Lee risk index models provide complementary prognostic perspectives and can help the clinician in the decision-making process.

Risk models do not dictate management decisions but should be regarded as one piece of the puzzle to be evaluated, in concert with the more traditional information at the physician’s disposal

Based on the existing data, assessment of serum biomarkers for patients undergoing non-cardiac surgery cannot be proposed for routine use, but may be considered in high-risk patients (METs ≤4 or with a revised cardiac risk index value >1 for vascular surgery and >2 for non-vascular surgery).

Va a ser raro que ya no estuviera tomando

Aspirin should be discontinued if the bleeding risk outweighs the potential cardiovascular benefit.121,123–125 For patients undergoing spinal surgery or certain neurosurgical or ophthalmological operations, it is recommended that aspirin be discontinued for at least seven days

Doble antiagregación• 5-25% de los pacientes con stents requieren cirugía no cardíaca en los 5

años siguientes. • El pronóstica de la trombosis del stent parece ser peor que la de una

oclusión coronaria de novo, y el cese prematuro de la DAG en pacientes con un implante de stent reciente es el predictor más poderoso para trombosis del stent

• El manejo de la DAG y la programación de cirugía debe discutirse con el cirujano para balancear el riesgo de sangrado mortal por antiagregantes (más conocido por cirujanos) y el riesgo mortal de la trombosis del stent sin DAG

• Para reducir el riesgo de sangrado y transfusión se recomienda demorar cirugía hasta completar DAG y en la medida de lo posible operar sin interrumpir aspirina.

• Elective surgery should be postponed for a minimum of 4 weeks and ideally for up to 3 months after BMS implantation. CONTRADICTORIO

• It is recommended that DAPT be administered for at least 1 month after BMS implantation in stable CAD, for 6 months after new-generation DES implantation, and for up to 1 year in patients after ACS, irrespective of revascularization strategy. Importantly, a minimum of 1 (BMS) to 3 (new-generation DES) months of DAPT might be acceptable, independently of the acuteness of coronary disease, in cases when surgery cannot be delayed for a longer period

Doble antiagregación• In patients needing surgery within a few days, current ESC

Guidelines recommend withholding clopidogrel and ticagrelor for five days and prasugrel for seven days prior to surgery unless there is a high risk of thrombosis. No tienen valor los test de función plaquetaria

• For patients with a very high risk of stent thrombosis, bridging therapy with intravenous, reversible glycoprotein inhibitors, such as eptifibatide or tirofiban, should be considered

• The use of low-molecular-weight heparin (LMWH) for bridging in these patients should be avoided.

• Dual anti-platelet therapy should be resumed as soon as possible after surgery and, if possible, within 48 hours

• Reversal of anti-platelet therapy: For patients receiving anti-platelet therapy, who have excessive or life-threatening peri-operative bleeding, transfusion of platelets is recommended.

Anticoagulación y AVK-HBPM• If the international normalized ratio(INR) is ≤1.5, surgery can be performed safely;

however, in anticoagulated patients with a high risk of thrombo-embolism—for example, patients with:– AF with a CHA2DS2-VASc [Cardiac failure, Hypertension, Age ≥75 (Doubled), Diabetes, Stroke

(Doubled) – Vascular disease, Age 65–74 and Sex category (Female)] score of ≥4– mechanical prosthetic heart valves, newly inserted biological prosthetic heart valves– mitral valvular repair (within the past 3 months)– recent venous thrombo-embolism (within 3 months) – thrombophilia,

• Discontinuation of VKAs is hazardous and these patients will need bridging therapy with unfractionated heparin (UFH) or therapeutic-dose LMWH. In general, there is better evidence for the efficacy and safety of LMWH

• In patients with a high thrombo-embolic risk, therapeutic doses of LMWH twice daily are recommended, and prophylactic once-daily doses in low-risk patients. The last dose of LMWH should be administered no later than 12 hours before the procedure

• LMWH or UFH is resumed at the pre-procedural dose 1–2 days after surgery, depending on the patient’s haemostatic status, but at least 12 hours after the procedure. VKAs should be resumed on day 1 or 2 after surgery— depending on adequate haemostasis

• In patients undergoing surgery with a low risk of serious bleeding, such as cataract- or minor skin surgery, no change in oral anticoagulation therapy is needed; however, it is wise to keep INR levels in the lower therapeutic range

Anticoagulación y NACO´s

• Have a well-defined ‘on’ and ‘off’ action, ‘bridging’ to surgery is in most cases unnecessary, due to their short biological half-lives. The overall recommendation is to stop NOACs for 2–3 times their respective biological half-lives prior to surgery in surgical interventions with ‘normal’ bleeding risk, and 4–5 times the biological half-lives before surgery in surgical interventions with high bleeding risk.

• Because of the fast ‘on’-effect of NOACs (in comparison with VKAs), resumption of treatment after surgery should be delayed for 1–2 (in some cases 3–5) days, until post-surgical bleeding tendency is diminished.

Anticoagulación y NACO´s

• For procedures with immediate and complete haemostasis, the NOAC can be resumed 6–8 h after the intervention. The same applies after atraumatic spinal/epidural anaesthesia or clean lumbar puncture (i.e. non-bloody tap).

• For many surgical interventions, however, resuming full dose anticoagulation within the first 48–72 h after the procedure may carry a bleeding risk that could outweigh the risk of cardio-embolism

Anticoagulación y sangrado• Patients who are receiving VKAs and who require reversal of

the anticoagulant effect for an urgent surgical procedure, low-dose (2.5–5.0 mg) intravenous or oral vitamin K is recommended. The effect of vitamin K on INR will first be apparent after 6–12 hours. If more immediate reversal of the anticoagulant effect of VKAs is needed, treatment with fresh-frozen plasma or prothrombin complex concentrate (PCC), is recommended, in addition to low-dose intravenous or oral vitamin K.

• In patients who are receiving LMWHs, the anticoagulant effect may be reversed within eight hours of the last dose because of the short half-life. If immediate reversal is required, intravenous protamine sulphate can be used, but anti-Xa activity is never completely neutralized (maximum 50%).

• When severe bleeding complications occur under the influence of NOACs, symptomatic treatment should be initiated (Figure 2) because of the lack of specific antidotes (these are currently under development). Preliminary data have shown a potential benefit for the use of PCC or activated PCC when bleeding occurs under the direct factor Xa inhibitor rivaroxaban, and is also applicable to apixaban and dabigatran, whereas haemodialysis is an effective method for eliminating dabigatran from the circulation but does not help when a direct factor Xa inhibitor has been used

Vacíos en la evidencia / Gaps in evidence

• ¿Cuál es el tipo óptimo, dosis y duración de los beta-bloqueantes en la cirugía de alto riesgo y sus beneficios en pacientes con riesgo quirúrgico intermedio?

• ¿Beneficios de las estatinas en cirugía de alto riesgo?• Estudio de intervención o resultados para biomarcadores,

hemodinámica perioperatoria y profundidad de la anestesia.• Cómo los factores de riesgo no cardíacos (fragilidad,

extremadamente bajo o muy alto IMC, anemia, situación inmunológica) interaccionan con los factores de riesgo CV e impactan sobre los resultados de la cirugía no cardíaca.

• Las escalas de riesgo que puedan predecir mortalidad por causas no cardíacas.

• Efectos de la situación del paciente, factores de riesgo no cardíacos, tamaño o habilidades del equipo quirúrgico, y la invasividad de los procedimientos sobre los resultados pronósticos.

European Heart Journal (2014) 35, 2781–2788

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