Conference Lectures

Dr.Ganesan C

ANTI -INFLAMMATORY EFFECTS OF PERIOPERATIVE STATIN THERAPY
Anesthesia  and  surgery  are  associated with a dramatically increased inflammatory response. Most long-termmorbidiyand mortality  following surgeryare due to cardiovascular and  cerebrovascular events .
The growingprevalence of atherosclerosis means that perioperative  myocardial infarction  and strokeis a significant issue for the anaesthesiologist.To  this aim , efforts have been undertaken to reduce the risk of  perioperative  MI  by risk stratification during preoperative assessment and subsequent initiation of preventive medical treatment .

Currentuncertainty over the best approachfor preventing fatal perioperative myocardial
infarctionlies in our inability, despitesophisticated testing methods to detect unstablecoronary plaque prior to surgery. Unstable plaque canbe present in patients with coronary luminathat appearnormal on coronary angiography. Therefore, relianceon medical therapy to blunt inflammation is currentlythe best practice for minimizing the risk that unstableplaque poses.

Atherosclerosis is generally held to be an inflammatory disease of the vascular wall, and it responds to treatment with diverse classes of anti-inflammatory medications, such as aspirin, beta-blockers, HMG-CoA reductase inhibitors (statins).Beyond  lipid-lowering  activity  in the prevention of atherosclerosis, statins exhibit action by improving vascular endothelial function, modulatinginflammatory responses, and maintaining plaque stabilitythereby preventing thrombus formation. These so-called‘‘pleiotropic’’ effects of statins are believed to occur within24 hr after statin initiation and prior to the reduction inserum cholesterol levels (weeks).The rapid onset of thepleiotropic effects was considered potentially useful toprevent perioperative MI, as plaque instability / disruption,most likely associated with perioperative inflammation, has  been recognized as a relevant cause of MI that is potentiallyresponsible for up to 50% of perioperative MIs.Ifstatin therapy can effectively diminish the inflammatoryresponse to surgical trauma, a perioperative MI might beprevented.
ATHEROSCLEROSIS — AN INFLAMMATORY DISEASE
Various factors can damage the endothelium. Diabetes, hypertension, smoking, ischemia and  homocystinemia . High levels of  LDL –C  initiates atherosclerosis , over half of death from atherosclerosis occurs in patients without raised LDL-C , other non traditional risk  factors such as“ inflammation” now considered to play an aggravating factor .

High LDL levels  augments  accumulation of  LDL particles  in the intima of arteries.These lipoproteins undergo various chemical alteration. Oxidised and glycated  LDL are powerful pro inflammatory agents that these chemical alteration induces local chemo-attractant cytokine production that contributes subsequent events that triggers atherosclerosis.

Local  factorsand circulating cytokines  such as  TNF-alpha and inerleukin-1 stimulate certain cell adhesion molecule. When the endothelium is stimulated  by cytokinesand endotoxins ,these  cell adhesion molecule induces attachment of  monocytes and T-lymphocytes to arterial endothelial wall . On entering the intimamonocytes transform into macrophages.Stimulated  macrophages  that ingest the LDL  cholesterol have a characteristic vacuolated appearance termed as “foam cells”. Collections of foam cells termed as “fatty streak”.The macrophage foam cells present in atherosclerotic plaque are metabolically active

These macrophage-foam cells rich source of factor such as smooth muscle cell mitogens, oxygen radicals  andmettalloproteinases. Also these foam cells destroy nitric oxide radicals decreasing the effect of nitricoxide .Smooth muscle cell migration in the tunica media in to arterial intima  .  This smooth muscle cells proliferation  responsible for the production of the fibrous cap that overlies the atherosclerotic plaques .

This fibrous cap exhibits significant metabolic activity and can undergo considerableremodelling and produce cytokines.Inflammatory cytokines cause the death, predominantly by apoptosis,of smooth muscle and foam cells. Necrosis of smooth muscle and foam cells results in the development of a necrotic lipid core in the plaque.
The initial fatty streak  evolves into fibrofatty lesion containing both atherosis and sclerosis  and transforms in to mature plaque.Atherosclerosis causes endothelial dysfunction , reduced levels of nitric oxide, promotes thrombotic status . In general endothelium in atherosclerosis favours aprothrombotic, vasoconstrictory environment,promoting  a greater chance of thrombus formation .

For anaesthesiologists myocardial infarction represents more common acute complication of atherosclerosis with stroke occurring less frequently but  to similar pathology .Fibrous cap fissuring or rupture is responsible for 60-70% of all non-surgical and anesthesia related myocardial infarctions and stroke.If the fibrous cap is thick , the plaque is relatively stable and will not tend to rupture . Should the fibrous cap is thin, the plaque may becomevulnerable to rupture .Indeed vulnerable plaque rupture at maximum wall stress , such increase in wall stress with increase in blood pressure / raise in heart rate.The extracellular matrix confers biomechanical strength to the plaque’s fibrous cap.decreased synthesis and increased degradation of extracellular matrix  in the presence of inflammation results in a thinning and weakening of fibrous cap.

It appears that inflammation plays a central role at all stages of atherosclerosis and makes plaques more vulnerable to rupture . Inflammation that is in adventitia of arteries and systemic inflammatory process are so important. Indeed systemic inflammation predict severity of atherosclerosis and future coronary events .

HS-CRP  levels have been shown to be an extremely useful predictor of  overall levels of inflammation, plaque stability and future cardiac events even in adults without known coronary artery disease. HS-CRP levels of 1.0 mg/L,1.0 mg/L to 3.0 mg/L and 3.0 mg/L represent low, medium and high cardiovascular risk respectively.

Large epidemiological studies have also found increased risk of vascular events in subjects withelevated basal levels of other inflammatory mediators such as the cytokines IL-6 and TNF-alpha. The focus on inflammation and the vulnerable plaque is an important aspect of current thinking about pathophysiology of atherosclerosis.

PATHOPHYSIOLOGY OF PERIOPERATIVE   MYOCARDIAL  INFARCTION:
Early PMI, the highest incidence occurring immediatelypostoperatively, is associated with the presence of high grade coronary lesions. Ischemia and infarction associated with this type of lesion are due to perioperative stress (most often during laryngoscopy and intubation, or extubation) causing tachycardia and hypertension that results in myocardial ischemia

The other 50% of PMI’s are caused by vulnerable coronary plaque rupture or endothelial desquamation with subsequent  thrombosis and occlusion of coronary arteries. This type of PMI is spread out over the perioperative period. They can even occur in the late postoperative period as long as 3 to 4 days after surgery. It has been suggested that the transformation  from a chronic stable atherosclerotic lesion to a vulnerable  plaque can indeed be an acute event. In this regard,it has been proved that  perioperative inflammatory response with release of inflammatory cytokines TNF alpha and IL-1 and IL-6 may make plaques more  vulnerable and explain late PMI.

Perioperative MI % of total

Causes of peri op   MI

Coronary    stenosis

Time  of death

Therapeutic options

54%

Stress

High grade

Days 1-3

Beta-blockers

46%

Plaque rupture

Absent or low grade

Evenly spread over perioperative period

Statins

STATINS   MECHANISMS  OF  ACTIONS ; Statins  competitively inhibit HMG-CoA reductase , the rate limiting step in  cholesterol biosynthesis in the liver. The reduction in cholesterol in hepatocytes causes an increase  in the expression of cell surface LDL receptors, resulting in improved extraction of LDL cholesterol from the circulation .Inhibition of this enzyme further prevents the conversion of  HMG Co-A to mevalonate, thus, preventing the downstream production of the isoprenoidgeranylpyrophosphate . The reduction of isoprenoid intermediates affect theG-proteins Rho, Rac, and Ras, which have a role in many intracellular signalling pathways.

The  multiple non-LDL mediated effects of statins predominantly promote anti-inflammatory and anti-coagulant processes. This  results in less inflammation, greater endothelial health and  ultimately, greater plaque stability. The plethora of non-LDL effects have been called the“pleiotropic” effects of statins . (The word “pleiotropy”, which is derived from two Greek words,  pleion and tropos, meaning “many turns”, was originally used  in genetics to describe the ability of a single gene to affect  multiple phenotypic effects in an organism.) That the pleiotropic  effects of statins are dose dependent and occur within hours of administration, is potentially of great importance to  anesthesiologists.


 

Inhibition of the isoprene pathway and also lowering of LDL cholesterol by statins has 3 main consequences in atherosclerotic tissue ;

1.Statin  therapy reduces inflammation,the anti-inflammatory effects are related to the
lower levels of LDL cholesterol and oxidised LDL, but also to better functioning of the endothelium, especially greater levels of nitric oxide.  Nitric oxide is not only a vasodilatory agent, but also possesses atheroprotective and anti-inflammatory properties. This is because nitric oxide decreases endothelial cell over-expression of leukocyte adhesion molecules, an important promoter of the atherosclerotic process  and a  process that makes plaques vulnerable to rupture . The result is that fewer macrophages become adherent to the endothelium, endothelial adhesion of leukocytes being a hallmark of inflammation.Less apoptosis of smooth muscle cells and greater production of collagen and elastin. Greater amounts of smooth muscle cells result in more collagen being present in plaques which enhances the strength of the fibrous cap.

2. Endothelial dysfunction is  improved because of  increase in endothelial nitric oxide levels

3. Statin therapy lowers the risk of thrombosis and  facilitates  fibrinolysis. A decrease in LDL cholesterol reduces endothelial and intimal inflammation reducing expression of    factor 7 while improving nitric oxide production.Decreasing LDL levels also reduces
excessive platelet aggregation.

Statins have reduced expressions of cytokines, chemokines, and adhesion molecules and a lowering of C-reactive protein (CRP) levels. CRP levels  have been shown to correlate with cardiovascular disease risk.  In  patients  with  elevated high-sensitivity CRP levels,
but  withouthyperlipidemia, treatment with statins decreased the incidence of stroke, myocardial infarction (MI) , and death from cardiovascular causes . Many of these pleiotropic effects of statins occur before a significant reduction in serum cholesterol levels . In normocholesterolemicand  hypercholesterolemic patients, endothelial function improved within 24 hours of statin  initiation , prior to  significant serum cholesterol reduction.

PERIOPERATIVE STATIN USE, PRACTICAL  CONSIDERATIONS  ;
Inflammation, not cholesterol, should be the target  .The optimal statin  choice and the target level of LDL cholesterol immediately  prior to surgery remain  controversial .  Regardless, the purpose of perioperative statin use should be reduction of the inflammatory  stress response to surgery ,  with the long-term goal  being  achievement of recommended  target lipid levels.

Patients with multiple cardiac risk factors represent  an especially high-risk group that benefits the most from statin therapy prior to vascular surgery, as they are likely to have more extensive disease and more extensive  inflammation in the coronary artery tree. Given the low incidence of side effects associated with statins, initiating a statin in patients with multiple cardiacrisk factors who are undergoing intermediate risk surgery may seem to be appropriate.It isadvisbaleto initiate a statin preferably as long before surgery as possible .

BEWARE THE REBOUND EFFECT WITH STATIN WITHDRAWAL

Statin  withdrawal  for several days following non cardiac surgery is a common practice . Acute withdrawal has been associated with an increase in markers of inflammation and oxidative stress, and an increase in cardiac events  when compared with continuation of statin therapy.For these reasons, a long-acting statin is preferred preoperatively in patients whose oral intake will be  compromised for several days after surgery  (eg, in gastric surgery).
Not all statins have similar effects on reducing LDL cholesterol levels. For example  although atorvastatin is extremely effective in lowering LDL-cholesterol, it does not increase HDL -C  as much as simvastatin.There  may also be differences between statins  in terms of their pleiotropic effects . An example of  this is that all  statins powerfully  inhibit  apoptosis of smooth muscle cells in atherosclerotic plaque, thereby improving plaque stability . However, pravastatin seems to be superior to  simvastatin  and  lovastain in this respect.

Drugs

Solubility

Daily dose
 (Mg)

Bioavailability
   (%)

Protein binding
(%)

Metabolism

 Elimination                    half-life (hr)

   Renal excretion

Lovastatin

Lipophilic

20-80

5

>90

CYP3A4

2-3

10

Simvastatin

Lipophilic

10-80

5

95-98

CYP3A4

1-3

13

Pravastatin

Hydrophilic

10-40

20

43-67

Sulfation

2-3

20

Flucastatin

Lipophilic

20-80

24

98

CYP2C9

0.5-3.0

6

Atorvastatin

Lipophilic

10-80

12

98

CYP3A4

13-16

2

Rosuvastatin

Hydrophilic

10-40

20

90

CYP2C9

19

10

Pitavastatin

Lipophilic

1-8

80

96

Hepatic
Uptake

11

NA

Cerivastatin

Lipophilic

0.2 -0.3

60

99

CYP3A4

2-3

30

SAFETY OF PERIOPERATIVE STATINS
Statins are well tolerated , side effects such as skeletal muscle and hepatic toxicities, which are rare but can be severe. Skeletal muscle toxicity associated with statin use can range from myalgiasto myositis (11 per 100 000 patient years)and, most  severely , rhabdomyolysis (1.6 to 3.4 per 100 000 patient years).Cerivastatin was withdrawn from the market in 2001 because of an increased incidence of rhabdomyolysis and associated fatalities. During the perioperative period, patients may be at higher risk for drug interactions ; in addition , perioperative use of analgesics may mask symptoms of
myalgia. Asymptomatic elevation of hepatic transaminases ( 110 per 100 0000 patient years) is quite common in statin users whichseems to be dose related and comparable among different statins .

CONTRAINDICATIONS TO PERIOPERATIVE STATIN THERAPY
As in the nonoperative setting, statins should not be initiated in patients with chronic liver disease, inflammatory muscle disease, severe renal disease, on concurrenttreatment with cyclosporine , fibrates, or high dose niacin, or in females with child bearing potential.