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1.  Perioperative visual loss after spine surgery 
World Journal of Orthopedics  2014;5(2):100-106.
Perioperative visual loss (POVL) is an uncommon, but devastating complication that remains primarily associated with spine and cardiac surgery. The incidence and mechanisms of visual loss after surgery remain difficult to determine. According to the American Society of Anesthesiologists Postoperative Visual Loss Registry, the most common causes of POVL in spine procedures are the two different forms of ischemic optic neuropathy: anterior ischemic optic neuropathy and posterior ischemic optic neuropathy, accounting for 89% of the cases. Retinal ischemia, cortical blindness, and posterior reversible encephalopathy are also observed, but in a small minority of cases. A recent multicenter case control study has identified risk factors associated with ischemic optic neuropathy for patients undergoing prone spinal fusion surgery. These include obesity, male sex, Wilson frame use, longer anesthetic duration, greater estimated blood loss, and decreased percent colloid administration. These risk factors are thought to contribute to the elevation of venous pressure and interstitial edema, resulting in damage to the optic nerve by compression of the vessels that feed the optic nerve, venous infarction or direct mechanical compression. This review will expand on these findings as well as the recently updated American Society of Anesthesiologists practice advisory on POVL. There are no effective treatment options for POVL and the diagnosis is often irreversible, so efforts must focus on prevention and risk factor modification. The role of crystalloids versus colloids and the use of α-2 agonists to decrease intraocular pressure during prone spine surgery will also be discussed as a potential preventative strategy.
doi:10.5312/wjo.v5.i2.100
PMCID: PMC4017302  PMID: 24829872
Perioperative visual loss; Ischemic optic neuropathy; Central retinal artery occlusion; Cortical blindness; Posterior reversible encephalopathy; Spine surgery; Prone positioning
2.  Postoperative Vision Loss after Spine Surgery: A Single-Institution Case-Control Comparison 
The Ochsner Journal  2014;14(2):179-183.
Background
Postoperative vision loss (POVL) after spine surgery is a rare but devastating outcome. We present the first case-control study from a single institution for POVL with the diagnoses of ischemic optic neuropathy or central vision loss after complex spine surgery.
Methods
POVL cases following spine surgeries between December 1995 and December 2010 at the Cleveland Clinic were identified retrospectively using administrative codes. Each instance of POVL was matched to 5 case-control patients based on age, gender, body mass index, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and hematocrit. Duration of anesthesia, fluid volumes, and hemodynamic measurements were then compared between POVL cases and control cases using Wilcoxon rank sum test.
Results
Six patients developed POVL. These patients had significantly greater blood loss (P=0.002, Wilcoxon test) and a significantly greater volume of red blood cells transfused (P=0.006) than the control patients. No other intraoperative measures differed significantly after Bonferroni correction for multiple outcomes.
Conclusion
We found that patients with POVL had significantly greater blood loss and significantly more red blood cell transfusions than their matched controls.
PMCID: PMC4052583  PMID: 24940126
Optic neuropathy–ischemic; spinal fusion; surgical procedures–operative; vision–ocular
3.  Ischemic Optic Neuropathy Following Spine Surgery 
Perioperative visual loss (POVL) is a devastating injury that has been reported infrequently after nonocular surgery. The most common cause of POVL is ischemic optic neuropathy (ION). Increasing numbers of cases of ION are being reported after spine surgery, but the etiology of postoperative ION remains poorly understood. After a MEDLINE search of the literature, we reviewed published case reports of ION, specifically those reported after spine surgery performed with the patient in the prone position. Most of the cases involved posterior ION (PION, n = 17), and the remainder anterior (AION, n = 5). Most patients had no or few preoperative vascular disease risk factors. All except one PION and 2 of 5 AION cases reported symptom onset within the first 24 hours after surgery. Visual loss was frequently bilateral (40% of AION, 47% of PION cases). Mean operative time exceeded 450 minutes. The lowest average intraoperative mean arterial blood pressure was 64 mm Hg and the mean lowest intraoperative hematocrit was 27%. The average blood loss was 1.7 L for AION and 5 L for PION patients. PION patients received an average of 8 L of crystalloid solution and 2.2 L of colloid intraoperatively. This compilation of case reports suggests that a combination of prolonged surgery in the prone position, decreased ocular perfusion pressure, blood loss and anemia/hemodilution, and infusion of large quantities of intravenous fluids are some of the potential factors involved in the etiology of postoperative ION. However, levels of blood pressure and anemia intraoperatively were frequently at levels considered acceptable in anesthesia practice. The etiology of postoperative ION remains incompletely understood. Potential strategies to avoid this complication are discussed.
PMCID: PMC2699455  PMID: 15632541
ischemic optic neuropathy; optic nerve; spine surgery; visual loss
4.  Anterior ischemic optic neuropathy after conventional coronary artery bypass graft surgery 
Summary
Background
Perioperative optic neuropathy is a disease which can lead to serious, irreversible damage of vision. This complication could be the result of non-ocular surgery, for example, cardiac or spinal procedures.
We present a case of anterior ischemic neuropathy (AION) which occurred following a conventional coronary artery bypass graft procedure.
Case Report
A 57-year-old man, 4 days after Conventional Coronary Artery Bypass Graft surgery as result of multi-vessel stabile coronary artery disease and history of anterolateral wall myocardial infarction, was admitted to the Eye Clinic due to significant loss of vision in his right eye. The patient had hypertension and was a heavy smoker. On admission, the slit lamp examination revealed a relative afferent pupillary defect in the right eye. The fundus examination showed optic disc edema with the presence of flame hemorrhages. Best corrected visual acuity (BCVA) was 0.02. The results of eye examination and fluorescein angiography confirmed the diagnosis of AION. Anti-aggregation and antithrombotic treatment was continued with steroids and vasodilators. After 7 days of this treatment we noticed the improvement of BCVA to 0.2. At 6-month follow-up, the vision was stable, and fundus examination revealed optic disc atrophy.
Conclusions
After cardiac surgical operations, such as coronary artery bypass graft procedures, anterior ischemic optic neuropathy may occur. In those cases, close cooperation between the various specialists is necessary.
doi:10.12659/MSM.881798
PMCID: PMC3539541  PMID: 21629193
coronary artery bypass graft; off-pump coronary artery bypass; perioperative ischemic neuropathy; anterior ischemic optic neuropathy
5.  Amaurosis after spine surgery: survey of the literature and discussion of one case 
European Spine Journal  2010;20(2):171-176.
Postoperative vision loss (POVL) associated with spine surgery is a well known, albeit very rare complication. POVL incidence after spinal surgery ranges from 0.028 to 0.2%; however, due to the increase in number and duration of annual complex spinal operations, the incidence may increase. Origin and pathogenesis of POVL remain frequently unknown. A 73-year-old patient presented with lumbar disc herniation with associated neurological deficits after conservative pre-treatment at a peripheral hospital. Known comorbidities included arterial hypertension, moderate arterial sclerosis, diabetes mellitus type 2, mildly elevated blood lipids and treated prostate gland cancer. During lumbar spine surgery in modified prone position the patient presented with an acute episode of severe hypotension, which required treatment with catecholamines and Trendelenburg positioning. Three hours postoperatively, a visual loss in the right eye occurred, resulting in a complete amaurosis. Antihypertensive medication, arteriosclerosis and intraoperative hypotension are possible causes for the POVL. Intraoperative administration of catecholamines and Trendelenburg positioning for treatment of systemic hypotension might further compromise ocular perfusion. In patients with comorbidities compromising arterial blood pressure, blood circulation and microcirculation, POVL must be considered as a severe postoperative complication. It is recommended to inform patients about such complications and obtain preoperative informed consent regarding POVL. Any recent modification of antihypertensive medication must be reported and analysed for potential intraoperative hemodynamic consequences, prior to spine surgery in prone position.
doi:10.1007/s00586-010-1557-9
PMCID: PMC3030706  PMID: 20809093
Amaurosis; Blood pressure; Spinal surgery; Prone position; Postoperative vision loss (POVL)
6.  Bilateral ischemic optic neuropathy after transurethral prostatic resection: a case report 
BMC Ophthalmology  2006;6:32.
Background
Nonarteritic ischemic optic neuropathy affects the anterior portion of the optic nerve and is characterized by sudden, painless visual loss. The affected eye has a relative afferent pupillary defect. The typical funduscopic appearance includes optic disc edema, with associated nerve fiber layer hemorrhage. Risk factors include advanced age, systemic hypertension, nocturnal hypotension, diabetes mellitus, and a small cup-to-disc ratio. Bilateral presentation is rare. Postoperative optic neuropathy has been associated with nonocular surgery; risk factors include a combination of prolonged surgical times, acute systemic hypotension, anemia due to blood loss, or prone positioning. We report for the first time a patient with bilateral, simultaneous anterior ischemic optic neuropathy after elective transurethral prostatic resection.
Case presentation
A 66-year old man underwent surgery for benign prostatic hyperplasia. The preoperative blood pressure was 140/85 mmHg, hemoglobin 15.9 g/dL, and hematocrit 48.6%. Two hours postoperatively, the blood pressure, hemoglobin, and hematocrit dropped dramatically. One day later, transient horizontal diplopia developed. Funduscopy showed a congenitally small cup-to-disc ratio without papillary edema. Other ocular findings were unremarkable. By 4 days postoperatively, sudden and painless amaurosis bilaterally developed when the patient awoke with nausea and vomiting. Visual acuity was no light perception bilaterally. The optic discs were swollen with small hemorrhages. Scans of the head and orbits and electrolyte levels were normal. There were no responses on visual evoked potentials bilaterally. The blood pressure was 90/50 mm Hg, the hemoglobin 7.0 g/dL, and the hematocrit 22.9%, necessitating infusion of three units of packed red blood cells. The blood pressure, hematocrit, and hemoglobin increased to normal levels. Three months later the visual acuity remained no light perception. The pupils were unreactive and there was marked optic disc atrophy bilaterally.
Conclusion
Bilateral and simultaneous acute ischemic optic neuropathy may be a rare but devastating surgical complication. The combination of anemia and hypotension may increase the risk of anterior ischemic optic neuropathy postoperatively after transurethral prostatic resection.
doi:10.1186/1471-2415-6-32
PMCID: PMC1624848  PMID: 17034630
7.  Transient bilateral post-operative visual loss in spinal surgery 
European Spine Journal  2011;21(Suppl 4):495-498.
Background
Post-operative visual loss (POVL) following spinal surgery is a rare but devastating complication. Although a number of intra-operative and post-operative factors have been implicated, the exact etiology may still remain unclear.
Purpose
To report a unique case of transient bilateral POVL in a patient who had undergone lumbar surgery in the prone position.
Study design/setting
This patient was followed up prospectively for 1 year.
Methods
Prospective follow-up of a single patient following spinal surgery, who developed transient bilateral POVL.
Results
This patient’s visual loss improved within 48 h.
Conclusion
This is the only documented case of POVL to have resolved completely within 48 h.
doi:10.1007/s00586-011-2117-7
PMCID: PMC3369061  PMID: 22170448
Post-operative; Visual loss; Spinal surgery
8.  Effects of on- and off-pump coronary artery surgery on graft patency, survival, and health-related quality of life: Long-term follow-up of 2 randomized controlled trials 
Objective:
Off-pump coronary artery bypass grafting reduces postoperative morbidity and uses fewer resources than conventional surgical intervention with cardiopulmonary bypass. However, only 15% to 20% of coronary artery bypass grafting operations use off-pump coronary artery bypass. One reason for not using off-pump coronary artery bypass might be the surgeon's concern about the long-term patency of grafts performed with this technique. Therefore our objective was to compare long-term outcomes in patients randomized to off-pump coronary artery bypass or coronary artery bypass grafting with cardiopulmonary bypass.
Methods:
Participants in 2 randomized trials comparing off-pump coronary artery bypass and coronary artery bypass grafting with cardiopulmonary bypass were followed up for 6 to 8 years after surgical intervention to assess graft patency, major adverse cardiac-related events, and health-related quality of life. Patency was assessed by using multidetector computed tomographic coronary angiographic analysis with a 16-slice scanner. Two blinded observers classified proximal, body, and distal segments of each graft as occluded or not. Major adverse cardiac-related events and health-related quality of life were obtained from questionnaires given to participants and family practitioners.
Results:
Patency was studied in 199 and health-related quality of life was studied in 299 of 349 survivors. There was no evidence of attrition bias. The likelihood of graft occlusion was no different between off-pump coronary artery bypass (10.6%) and coronary artery bypass grafting with cardiopulmonary bypass (11.0%) groups (odds ratio, 1.00; 95% confidence interval, 0.55–1.81; P>.99). Graft occlusion was more likely at the distal than the proximal anastomosis (odds ratio, 1.11; 95% confidence interval, 1.02–1.20). There were also no differences between the off-pump coronary artery bypass and coronary artery bypass grafting with cardiopulmonary bypass groups in the hazard of death (hazard ratio, 1.24; 95% confidence interval, 0.72–2.15) or major adverse cardiac-related events or death (hazard ratio, 0.84; 95% confidence interval, 0.58–1.24), or mean health-related quality of life across a range of domains and instruments.
Conclusions:
Long-term health outcomes with off-pump coronary artery bypass are similar to those with coronary artery bypass grafting with cardiopulmonary bypass when both operations are performed by experienced surgeons.
doi:10.1016/j.jtcvs.2008.09.046
PMCID: PMC2836483  PMID: 19185140
9.  Fenestrated Endovascular Grafts for the Repair of Juxtarenal Aortic Aneurysms 
Executive Summary
Endovascular repair of abdominal aortic aneurysm (AAA) allows the exclusion of the dilated aneurismal segment of the aorta from the systematic circulation. The procedure requires, however, that the endograft extends to the healthy parts of the aorta above and below the aneurysm, yet the neck of a juxtarenal aortic aneurysm (JRA) is too short for a standard endovascular repair. Fenestrated endovascular aortic repair (f—EVAR) provides a solution to overcome this problem by enabling the continuation of blood flow to the renal and visceral arteries through holes or ‘fenestrations’ in the graft. These fenestrations are designed to match the ostial diameter of the renal and visceral arteries.
There are three varieties fenestration, small, large, and scallop, and their location needs to be customized to fit the anatomy of the patient. If the device is not properly designed, if the alignment is inaccurate, or if the catheterization of the visceral arteries is not possible, the procedure may fail. In such cases, conversion to open surgery may become the only option as fenestrated endografts are not retrievable.
It is recommended that a stent be placed within each small fenestration to the target artery to prevent shuttering of the artery or occlusion. Many authors have noted an increased risk of vessel occlusion in unstented fenestrations and scallops.
Once placed in a patient, life-long follow-up at regular intervals is necessary to ensure the graft remains in its intended location, and that the components have adequate overlap. Should the need arise, routine follow-up allows the performance of timely and appropriate intervention through detection of events that could impact the long-term outcomes.
Alternative Technology
The technique of fenestrated endovascular grafting is still in evolution and few studies have been with published mid-term outcome data. As the technique become more common in vascular surgery practices, it will be important to determine if it can provide better outcomes than open surgical repair (OSR).
In an OSR approach, aortic clamping above one or both renal arteries, or above the visceral arteries, is required. The higher the level of aortic clamping, the greater the risk of cardiac stress and renal or visceral ischemia. During suprarenal or supraceliac aortic clamping, strain-induced myocardial ischemia may also occur due to concomitant rise in cardiac afterload and a decrease in cardiac output. Reports indicate that 6% of patients undergoing surgical repair develop myocardial infarction. The ideal level of clamp location remains controversial with conflicting views having been reported.
Method
A search of electronic databases (OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library, and the International Agency for Health Technology Assessment [INAHTA] database was undertaken to identify evidence published from January 1, 2004 to December 19, 2008. The search was limited to English-language articles and human studies. The automatic search alerts were received and reviewed up to March 23, 2009.
The literature search and automatic search update identified 320 citations, of which 13 met inclusion/exclusion criteria. One comparative study presented at an international seminar, five single-arm studies on f—EVAR, and 7 studies on OSR (one prospective and six retrospective) were considered for this analysis.
To grade the strength of the body of evidence, the grading system formulated by the GRADE working group and adopted by MAS, was applied. The GRADE system classifies evidence quality as high (Grade A), moderate (Grade B), or low (Grade C) according to four key elements: study design, study quality, consistency across studies, and directness.
A summary of the characteristics of the f—EVAR and OSR studies found through the literature search is shown in Table ES-1.
Patient Characteristics: f–EVAR Studies versus OSR Studies
JRA, Juxtarenal aortic aneurysm; SRA, Suprarenal aortic aneurysm; TAA, Thoracic aortic aneurysm
Mortality Outcomes
The pooled estimate for 30-day mortality was 1.8% among the f—EVAR studies and 3.1% among the OSR studies that reported data for the repair of JRA separately. The pooled estimate for late mortality was 12.8% among the f—EVAR studies and 23.7% among the OSR studies that reported data for JRA separately.
Visceral Artery Events Reported in f—EVAR Studies
Renal Events during f-EVAR
A total of three main renal arteries and two accessory renal arteries became occluded during the procedure. These were all due to technical issues, except one accessory renal artery in which the artery was intentionally covered. One patient required open surgery following the procedure.
Renal Events During the follow-up
A total of 12 renal arteries (12 patients) were found to be occluded during follow-up. In two patients, the same side accessory renal artery was also occluded. Four (1.5%) patients lost one kidney and five (2.3%) patients underwent dialysis, three (1.4%) of which became permanent.
A total of 16 cases of renal artery stenosis (16 patients) occurred during follow-up. Eight of these were treated and eight were observed. Segmental renal infarcts were found in six patients but renal function was not impaired.
Mesenteric Events during f-EVAR
Three mesenteric events occurred during the f—EVAR procedures resulting in two deaths. One patient developed bowel ischemia due to embolization of the superior mesenteric artery (SMA); this patient died 13 days after the procedure from multiorgan failure. One patient died eights days after the procedure from mesenteric ischemia and bowel perforation. The third SMA event occurred during surgery with subsequent occlusion in early follow-up.
Mesenteric Events during Follow-up
During follow-up, five (1.8%) SMA occlusions/partial occlusions and one SMA stenosis were noted. Three of the five patients with SMA occlusion/partial occlusion remained asymptomatic and no further intervention was necessary. One patient underwent SMA bypass surgery and in two patients, the problem solved by SMA stenting. A summary of the outcomes reported in the f—EVAR and OSR studies is shown in Table ES-2.
Summary of Outcomes: Fenestrated Endovascular Graft Versus Open Surgical Repair for Treatment of Juxtarenal Aortic Aneurysm
Summary
Short- and medium-term results (up to 2 years) of f—EVAR for the repair of JRA showed that outcomes in f—EVAR series compare favourably with the figures for the OSR series; however, uncertainty remains regarding the long-term results. The following observations are based on low quality evidence.
F—EVAR has lower 30-day mortality than OSR (1.8% vs. 3.1%) and a lower late-mortality over the period of time that patients have been followed (12.8% vs. 23.7%).
There is a potential for the loss of target vessels during or after f—EVAR procedures. Loss of a target vessel may lead to loss of its respective end organ. The risk associated with this technique is mainly due to branch vessel ischemia or occlusion (primarily among the renal arteries and SMA). Ischemia or occlusion of these arteries can occur during surgery due to technical failure and/or embolization or it may occur during follow-up due to graft complications such as graft migration, component separation, or arterial thrombosis. The risk of kidney loss in this series of f—EVAR studies was 1.5% and the risk of mesenteric ischemia was 3.3%. In the OSR studies, the risk of developing renal insufficiency was 14.4% and the risk of mesenteric ischemia was 2.9%.
F—EVAR has a lower rate of postoperative cardiac and pulmonary complications.
Endoleak occurs in 22.5% of patients undergoing f—EVAR (all types) and about 8% of these require treatment. Most of the interventions performed to treat such endoleaks conducted using a minimally invasive approach.
Due to the complexity of the technique, patients must be appropriately selected for f—EVAR, the procedure performed by highly experienced operators, and in centers with advanced, high-resolution imaging systems to minimize the risk of complications.
Graft fenestrations have to be custom designed for each patient to fit and match the anatomy of their visceral arteries. Planning and sizing thus requires scrutiny of the target vessels with a high degree precision. This is important not only to prevent end organ ischemia and infarction, but to avoid prolonging procedures and subsequent adverse outcomes.
Assuming the average cost range of FEVAR procedure is $24,395-$30,070 as per hospital data and assuming the maximum number of annual cases in Ontario is 116, the average estimated cost impact range to the province for FEVAR procedures is $2.83M-$3.49M annually.
PMCID: PMC3377528  PMID: 23074534
10.  Human Erythropoietin Effect in Postoperative Visual Loss Following Spine Surgery: A Case Report 
Introduction:
Postoperative visual loss (POVL) has become the focus of attention for anesthesiologists as a hallmark of perioperative management in spine surgery. A number of Intraoperative and postoperative factors has been documented but the exact etiology is still unclear. Nowadays, perioperative management and also complete curing of POLV is a big question of ophthalmologists and anesthesiologists. The purpose of this case report is to present a unique experience of complete curing the POLV.
Case Presentation:
Our patient was a 61-year-old man, with 75 kg weight and 180 cm height. The patient had no history of visual impairment except mild cataract in his right eye. The patient had a history of diffuse idiopathic skeletal hyperostosis (DISH). The patient had undergone lumbar surgery in prone position. The operation time was about 6 hours. About 30 minutes after transferring to postanesthesia care unit (PACU), patient was awake and complained of losing his eyesight. There was no vision and light perception in his right eye on primary examination. Urgent ophthalmologist consultation was requested. In ophthalmology examinations, the pupil reflex to light was absent in the right eye. After obtaining patients and his family informed consent, four hours after the operation, 40000 I.U. of recombinant human erythropoietin (rhEPO) was administered for patient in PACU (IV infusion, in 30 min). An ophthalmologist visited him every 6 hours after administration of rhEPO. The patient was transferred to intensive care unit (ICU) one hour later with total visual loss in the right eye. Ophthalmologic examination after the second dose of rhEPO, 30 hours after the operation, reported pupil reflex enhancement and light perception in his right eye. Finally the third dose of rhEPO (40000 I.U., IV infusion) was administered on the third day. Ophthalmologic examination after the third dose of rhEPO, 60 hours after the operation, reported normal pupillary light reflex of the right eye and visual acuity improvement to 20/20. The patient was discharged from hospital after six days, with normal visual acuity and without any new complications except surgical site pain.
Conclusions:
Our case report showed the therapeutic effect of rhEPO in complete curing of POVL. Regarding the side effects of EPO such as thrombogenic effects or mild hemodynamic changes like transient sinus tachycardia during infusion, it seems that beneficial effects of EPO is more than its disadvantages and expenses, for patients with POVL.
doi:10.5812/aapm.7291
PMCID: PMC3997951  PMID: 24790903
Complications; Optic Neuropathy, Ischemic; Postoperative Period; Postoperative; Spinal Cord Ischemia; Vision Disorders
11.  A surgical approach to coexistent coronary and carotid artery disease. 
Heart  1997;77(2):164-167.
OBJECTIVE: To assess the early results of combined coronary artery bypass graft surgery and carotid endarterectomy. DESIGN: Retrospective and ongoing analysis of patients who underwent combined coronary artery bypass graft surgery and carotid endarterectomy. SETTING: Cardiothoracic unit in a London teaching hospital. PATIENTS: From June 1987 to March 1995, 64 patients were identified. They were patients who were scheduled to have coronary artery bypass graft surgery or required urgent coronary revascularisation and who were found to have significant coexistent carotid disease. (Unilateral carotid stenosis > 70%, bilateral carotid stenosis > 50%, or unilateral carotid stenosis > 50% with contralateral occlusion.) INTERVENTIONS: Both procedures were performed during one anaesthesia: the carotid endarterectomy was performed first without cardiopulmonary bypass. After completion of carotid endarterectomy, coronary artery bypass graft surgery was performed. MAIN OUTCOME MEASURES: The incidence of stroke, transient ischaemic attack, and myocardial infarction in the early postoperative period was analysed. RESULTS: Myocardial revascularisation was successful in all 64 patients. There were no perioperative infarcts. In three patients (4.7%) a new neurological deficit developed postoperatively: two recovered fully before hospital discharge. CONCLUSIONS: Combined coronary artery bypass graft surgery and carotid endarterectomy were performed safely and with good results.
PMCID: PMC484667  PMID: 9068401
12.  Intravascular Ultrasound to Guide Percutaneous Coronary Interventions 
Executive Summary
Objective
The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of using intravascular ultrasound (IVUS) as an adjunctive imaging tool to coronary angiography for guiding percutaneous coronary interventions.
Background
Intravascular Ultrasound
Intravascular ultrasound is a procedure that uses high frequency sound waves to acquire 3-dimensional images from the lumen of a blood vessel. The equipment for performing IVUS consists of a percutaneous transducer catheter and a console for reconstructing images. IVUS has been used to study the structure of the arterial wall and nature of atherosclerotic plaques, and obtain measurements of the vessel lumen. Its role in guiding stent placement is also being investigated. IVUS is presently not an insured health service in Ontario.
Clinical Need
Coronary artery disease accounts for approximately 55% of cardiovascular deaths, the leading cause of death in Canada. In Ontario, the annual mortality rate due to ischemic heart disease was 141.8 per 100,000 population between 1995 and 1997. Percutaneous coronary intervention (PCI), a less invasive approach to treating coronary artery disease, is used more frequently than coronary bypass surgery in Ontario. The number of percutaneous coronary intervention procedures funded by the Ontario Ministry of Health and Long-term Care is expected to increase from approximately 17, 780 in 2004/2005 to 22,355 in 2006/2007 (an increase of 26%), with about 95% requiring the placement of one or more stents. Restenosis following percutaneous coronary interventions involving bare metal stents occurs in 15% to 30% of the cases, mainly because of smooth muscle proliferation and migration, and production of extracellular matrix. In-stent restenosis has been linked to suboptimal stent expansion and inadequate lesion coverage, while stent thrombosis has been attributed to incomplete stent-to-vessel wall apposition. Since coronary angiography (the imaging tool used to guide stent placement) has been shown to be inaccurate in assessing optimal stent placement, and IVUS can provide better views of the vessel lumen, the clinical utility of IVUS as an imaging tool adjunctive to coronary angiography in coronary intervention procedures has been explored in clinical studies.
Method
A systematic review was conducted to answer the following questions:
What are the procedure-related complications associated with IVUS?
Does IVUS used in conjunction with angiography to guide percutaneous interventions improve patient outcomes compared to angiographic guidance without IVUS?
Who would benefit most in terms of clinical outcomes from the use of IVUS adjunctive to coronary angiography in guiding PCIs?
What is the effectiveness of IVUS guidance in the context of drug-eluting stents?
What is the cost-effectiveness ratio and budget impact of adjunctive IVUS in PCIs in Ontario?
A systematic search of databases OVID MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) database for the period beginning in May 2001 until the day of the search, November 4, 2005 yielded 2 systematic reviews, 1 meta-analysis, 6 randomized controlled trials, and 2 non-randomized studies on left main coronary arteries. The quality of the studies ranged from moderate to high. These reports were combined with reports from a previous systematic review for analysis. In addition to qualitative synthesis, pooled analyses of data from randomized controlled studies using a random effect model in the Cochrane Review Manager 4.2 software were conducted when possible.
Findings of Literature Review & Analysis
Safety
Intravascular ultrasound appears to be a safe tool when used in coronary interventions. Periprocedural complications associated with the use of IVUS in coronary interventions ranged from 0.5% in the largest study to 4%. Coronary rupture was reported in 1 study (1/54). Other complications included prolonged spasms of the artery after stenting, dissection, and femoral aneurysm.
Effectiveness
Based on pooled analyses of data from randomized controlled studies, the use of intravascular ultrasound adjunctive to coronary intervention in percutaneous coronary interventions using bare metal stents yielded the following findings:
For lesions predominantly at low risk of restenosis:
There were no significant differences in preintervention angiographic minimal lumen diameter between the IVUS-guided and angiography-guided groups.
IVUS guidance resulted in a significantly larger mean postintervention angiographic minimal lumen diameter (weighted mean difference of 0.11 mm, P = .0003) compared to angiographic guidance alone.
The benefit in angiographic minimal lumen diameter from IVUS guidance was not maintained at 6-month follow-up, when no significant difference in angiographic minimal lumen diameter could be detected between the two arms (weighted mean difference 0.08, P = .13).
There were no statistically significant differences in angiographic binary restenosis rates between IVUS-guidance and no IVUS guidance (Odds ratio [OR] 0.87 in favour of IVUS, 95% Confidence Interval [CI] [0.64–1.18], P = 0.37).
IVUS guidance resulted in a reduction in the odds of target lesion revascularization (repeat percutaneous coronary intervention or coronary bypass graft) compared to angiographic guidance alone. The reduction was statistically significant at a follow-up period of 6 months to 1 year, and at a follow-up period of 18 month to 2 years (OR 0.52 in favour of IVUS, 95% CI [0.33–0.81], P = .004).
Total revascularization rate (either target lesion or target vessel revascularization) was significantly lower for IVUS-guided patients at 18 months to 2.5 years after intervention (OR 0.43 in favour of IVUS, 95% CI [0.29–0.63], p < .0001).
There were no statistically significant differences in the odds of death (OR 1.36 in favour of no IVUS, P =0.65) or myocardial infarction (OR 0.95 in favour of IVUS, P = 0.93) between IVUS-guidance and angiographic guidance alone at up to 2.5 years of follow-up
The odds of having a major cardiac event (defined as death, myocardial infarction, and target lesion or target vessel revascularization) were significantly lower for patients with IVUS guidance compared to angiographic guidance alone during follow-up periods of up to 2.5 years (OR 0.53, 95% CI [0.36–0.78], P = 0.001). Since there were no significant reductions in the odds of death or myocardial infarction, the reduction in the odds of combined events reflected mainly the reduction in revascularization rates.
For lesions at High Risk of Restenosis:
There is evidence from one small, randomized controlled trial (n=150) that IVUS-guided percutaneous coronary intervention in long de novo lesions (>20 mm) of native coronary arteries resulted in statistically significant larger minimal lumen Diameter, and statistically significant lower 6-month angiographic binary restenosis rate. Target vessel revascularization rate and the rate of combined events were also significantly reduced at 12 months.
A small subgroup analysis of a randomized controlled trial reported no benefit in clinical or angiographic outcomes for IVUS-guided percutaneous coronary interventions in patients with diabetes compared to those guided by angiography. However, due to the nature and size of the analysis, no firm conclusions could be reached.
Based on 2 small, prospective, non-randomized controlled studies, IVUS guidance in percutaneous coronary interventions of left main coronary lesions using bare metal stents or drug-eluting stents did not result in any benefits in angiographic or clinical outcomes. These findings need to be confirmed.
Interventions Using Drug-Eluting Stents
There is presently no evidence on whether the addition of IVUS guidance during the implantation of drug-eluting stents would reduce incomplete stent apposition, or improve the angiographic or clinical outcomes of patients.
Ontario-Based Economic Analysis
Cost-effectiveness analysis showed that PCIs using IVUS guidance would likely be less costly and more effective than PCIs without IVUS guidance. The upfront cost of adjunctive use of IVUS in PCIs ranged from $1.56 million at 6% uptake to $13.04 million at 50% uptake. Taking into consideration cost avoidance from reduction in revascularization associated with the use of IVUS, a net saving of $0.63 million to $5.2 million is expected. However, since it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS can be generalized to clinical settings in Ontario, further analysis on the budget impact and cost-effectiveness need to be conducted once Ontario-specific revascularization rates are verified.
Factors to be Considered in the Ontario Context
Applicability of Findings to Ontario
The interim analysis of an Ontario field evaluation that compared drug-eluting stents to bare metal stents showed that the revascularization rates in low-risk patients with bare metal stents were much lower in Ontario compared to rates reported in randomized controlled trials (7.2% vs >17 %). Even though IVUS is presently not routinely used in the stenting of low-risk patients in Ontario, the revascularization rates in these patients in Ontario were shown to be lower than those reported for the IVUS groups reported in published studies. Based on this information and previous findings from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rates from IVUS guidance can be generalized to Ontario. In light of the above findings, it is advisable to validate the reported benefits of IVUS guidance in percutaneous coronary interventions involving bare metal stents in the Ontario context.
Licensing Status
As of January 16, 2006, Health Canada has licensed 10 intravascular ultrasound imaging systems/catheters for transluminal intervention procedures, most as class 4 medical devices.
Current Funding
IVUS is presently not an insured procedure under the Ontario Health Insurance Plan and there are no professional fees for this procedure. All costs related to the use of IVUS are covered within hospitals’ global budgets. A single use IVUS catheter costs approximately $900CDN and the procedure adds approximately 20 minutes to 30 minutes to a percutaneous coronary intervention procedure.
Diffusion
According to an expert consultant, current use of IVUS in coronary interventions in Ontario is probably limited to high-risk cases such as interventions in long lesions, small vessels, and bifurcated lesions for which images from coronary angiography are indeterminate. It was estimated that IVUS is being used in about 6% of all percutaneous coronary interventions at a large Ontario cardiac centre.
Expert Opinion
IVUS greatly enhances the cardiac interventionists’ ability to visualize and assess high-risk lesions such as long lesions, narrow lesions, and bifurcated lesions that may have indeterminate angiographic images. Information from IVUS in these cases facilitates the choice of the most appropriate approach for the intervention.
Conclusion
The use of adjunctive IVUS in PCIs using bare metal stents in lesions predominantly at low risk for restenosis had no significant impact on survival, myocardial infarction, or angiographic restenosis rates up to 2.5 years after intervention.
The use of IVUS adjunctive to coronary angiography in percutaneous coronary interventions using bare metal stents in lesions predominantly at low risk for restenosis significantly reduced the target lesion and target vessel revascularization at a follow-up period of 18 months to 2.5 years.
One small study suggests that adjunctive IVUS in PCIs using bare metal stents in long lesions (>20 mm) significantly improved the 6-month angiographic restenosis rate and one-year target lesion revascularization rate. These results need to be confirmed with large randomized controlled trials.
Based on information from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS in the placement of bare metal stents can be generalized to clinical settings in Ontario.
There is presently insufficient evidence available to determine the impact of adjunctive IVUS in percutaneous interventions in high-risk lesions (other than long lesions) or in PCIs using drug-eluting stents.
PMCID: PMC3379536  PMID: 23074482
13.  Patients' Perspective on Full Disclosure and Informed Consent Regarding Postoperative Visual Loss Associated With Spinal Surgery in the Prone Position 
Mayo Clinic Proceedings  2011;86(9):865-868.
OBJECTIVE: To determine patients' opinions regarding the person, method, and timing for disclosure of postoperative visual loss (POVL) associated with high-risk surgery.
PATIENTS AND METHODS: On the basis of findings of a pilot study involving 219 patients at Mayo Clinic in Florida, we hypothesized that at least 80% of patients would prefer disclosure of POVL by the surgeon, during a face-to-face discussion, before the day of scheduled surgery. To test the hypothesis, we sent a questionnaire to 437 patients who underwent prolonged prone spinal surgical procedures at Mayo Clinic in Rochester, MN, or Mayo Clinic in Arizona from December 1, 2008, to December 31, 2009.
RESULTS: Among the 184 respondents, 158 patients gave responses supporting the hypothesis vs 26 with at least 1 response not supporting it, for an observed incidence of 86%. The 2-sided 95% confidence interval is 80% to 91%.
CONCLUSION: At least 80% of patients prefer full disclosure of the risk of POVL, by the surgeon, during a face-to-face discussion before the day of scheduled surgery. This finding supports development of a national patient-driven guideline for disclosing the risk of POVL before prone spinal surgery.
doi:10.4065/mcp.2011.0279
PMCID: PMC3258003  PMID: 21878598
14.  Bilateral anterior ischemic optic neuropathy after bilateral neck dissection 
Purpose:
The risk of visual loss after nonocular surgeries is very low, between 0.2% and 4.5%. According to the American Society of Anesthesiologists, ischemic optic neuropathy has been reported mostly after spinal surgery (54.2%), followed by cardiac surgery and radical neck dissection (13.3%). It may occur in association with some conditions that include systemic hypotension, acute blood loss and hypovolemia.
Case report:
A 46-year-old woman, whose diagnosis was laryngeal squamous cell carcinoma, complained of visual loss in her right eye two days after surgery (laryngectomy with bilateral radical neck dissection and left jugular ligature) and one day later in her left eye. The diagnosis was nonarteritic anterior ischemic optic neuropathy.
Conclusion:
Anterior ischemic optic neuropathy related to nonocular surgery is usually bilateral and its prognosis is very poor, resulting in blindness or severe visual loss. Although rare, patients should be warned about this complication, which has a profound impact on quality of life, since no therapeutic measure, including correction of hypotension and anemia, seems to improve the prognosis of this complication.
PMCID: PMC2835530  PMID: 20234774
ischemic optic neuropathy; visual loss; radical neck dissection; blood loss
15.  Arterial bypass grafting of the coronary circulation 
Surgical coronary bypass has evolved continually, and recent developments favor performing coronary grafts with all-arterial conduits in order to obtain better long-term graft patencies. With bilateral internal mammary artery grafts and both radial arteries, four excellent arterial conduits exist for revascularization of the majority of multivessel disease patients, including those with valve disorders.
Using contemporary surgical techniques, it is possible to obtain greater than 95% overall long-term graft patencies that translate into better outcomes, including improved survival, freedom from myocardial infarction, percutaneous coronary intervention , and redo coronary bypass.
Two-thirds of patients receive a right internal mammary artery to the left anterior descending , a left internal mammary artery to the circumflex coronary artery system, and a radial artery to the right coronary artery Using newer management techniques, early postoperative complications, including the incidence of sternal infections, are extremely uncommon, and all-arterial grafts currently are used in over 75% of multivessel patients including those with concomitant valve disease. Because patencies and outcomes are so much better than with standard coronary bypass or percutaneous coronary intervention, referring physicians frequently favor all-arterial bypass as the primary therapy for patients with prognostically serious multivessel obstruction. Thus, all-arterial bypass could play an increasingly important role in the future treatment of severe coronary atherosclerosis.
PMCID: PMC3563437  PMID: 23439991
coronary artery bypass; IMA grafts; coronary artery disease; graft patency; outcome analysis
16.  Bilateral internal thoracic artery grafting 
Annals of Cardiothoracic Surgery  2013;2(4):485-492.
The effectiveness of the left internal mammary artery graft to the anterior descending coronary artery as a surgical strategy has been shown to improve the survival rate and decrease the risk of adverse cardiac events in patients undergoing coronary bypass surgery. These clinical benefits appear to be related to the superior short and long-term patency rates of the internal thoracic artery graft. Although the advantages of using of both internal thoracic arteries (ITA) for bypass grafting have taken longer to prove, recent results from multiple data sets now support these findings. The major advantage of bilateral ITA grafting appears to be improved survival rate, while the disadvantages of complex ITA grafting include the increased complexity of operation, and an increased risk of wound complications. While these short-term disadvantages have been mitigated in contemporary surgical practice, they have not eliminated. Bilateral ITA grafting should be considered the procedure of choice for patients undergoing coronary bypass surgery that have a predicted survival rate of longer than ten years.
doi:10.3978/j.issn.2225-319X.2013.07.04
PMCID: PMC3741891  PMID: 23977627
Coronary bypass surgery; bilateral internal thoracic artery grafting
17.  Surgery for nonarteritic anterior ischemic optic neuropathy 
The Cochrane database of systematic reviews  2012;1:10.1002/14651858.CD001538.pub3.
Background
Nonarteritic ischemic optic neuropathy (NAION) is characterized by sudden and painless loss of vision in the eye, accompanied by pallid swelling of the optic disc. Its etiology is unknown and no medical therapy has been proven effective in treating this condition. Optic nerve decompression surgery, a proposed treatment for NAION, involves making two or more slits or a window in the tissue surrounding the optic nerve, thereby allowing cerebrospinal fluid to escape, and theoretically reducing the pressure surrounding the optic nerve.
Objectives
The objective of this review was to assess the safety and efficacy of surgery compared with other treatment or no treatment in people with nonarteritic ischemic optic neuropathy.
Search methods
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 11), MEDLINE (January 1950 to November 2011), EMBASE (January 1980 to November 2011), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (http://clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 19 November 2011.
Selection criteria
All randomized trials of surgical treatment of NAION were eligible for inclusion in this review.
Data collection and analysis
We obtained full copies of all potentially relevant articles. One author extracted data which was verified by another author. No data synthesis was required.
Main results
The one included trial randomized 258 participants and was stopped early for futility. At the time of the 24-month report the follow-up rate was 95.3% for six months and 67.4% for 24 months (174 participants; 89 careful follow up and 85 surgery). There was no evidence of a benefit of surgery on visual acuity. Measurements of visual acuity and visual fields were performed by a technician masked to the treatment received. At six months 32.0% of the surgery group had improved visual acuity by three or more lines compared with 42.6% of the careful follow up group (unadjusted relative risk (RR) 0.75, 95% confidence interval (CI) 0.54 to 1.04). At 24 months 29.4% of the surgery group had improved compared with 31.0% of the careful follow up group (unadjusted RR 0.95, 95% CI 0.60 to 1.49). Participants who underwent surgery had a greater risk of losing three or more lines of vision, although the increased risk was not statistically significant. At six months 18.9% in the surgery group had worsened compared with 14.8% in the careful follow up group (RR 1.28; 95% CI 0.73 to 2.24). At 24 months 20.0% in the surgery group had worsened compared with 21.8% in the careful follow up group (RR 0.92; 95% CI 0.51 to 1.64). Participants who received surgery experienced both intraoperative and postoperative adverse events, including central retinal artery occlusion during surgery and light perception vision at six months (one participant); and immediate loss of light perception following surgery and loss of vision that persisted to the 12-month visit (two participants). In the careful follow-up group, two participants had no light perception at the six-month follow-up visit; one of these had improved to light perception at 12 months. Pain was the most common adverse event in the surgery group (17% in surgery group versus 3% in the careful follow-up group at one week). Diplopia (double-vision) was the next most common complication (8% in the surgery group versus 1% in the careful follow-up group at one week); at three months there was no statistically significant difference in proportion of participants with diplopia between the two groups.
Authors' conclusions
Results from the single trial indicate no evidence of a beneficial effect of optic nerve decompression surgery for NAION. Future research should focus on increasing our understanding of the etiology and prognosis of NAION. New treatment options should be examined in the context of randomized clinical trials.
doi:10.1002/14651858.CD001538.pub3
PMCID: PMC3845212  PMID: 22258945
18.  Perioperative vision loss: A complication to watch out 
Postoperative vision loss, a rare but devastating complication, has been reported after spine, cardiac, and head–neck surgeries. Its incidence following spine surgeries exceeds that after cardiothoracic surgeries. Various causes attributed to postoperative blindness include ischemic optic neuropathy, central or branch retinal artery occlusion, cortical blindness, and rarely external ocular injury. Other contributory factors described are microvascular diseases and intraoperative hemodynamic compromise. However, the exact association of these factors with postoperative blindness has not yet been confirmed. In this review, we describe causes, presentation, and treatment of postoperative blindness and also recommend practical guidelines to avoid this complication. The search strategies for this review included both search of electronic databases as well as manual search of relevant articles.
doi:10.4103/0970-9185.92427
PMCID: PMC3275941  PMID: 22345938
Postoperative blindness; spine surgery; vision loss
19.  Enhanced External Counterpulsation (EECP) 
Executive Summary
Objective
To assess the effectiveness, and cost effectiveness of EECP in patients with severe anginal symptoms, secondary to chronic coronary disease, who are unresponsive to exhaustive pharmacotherapy and not candidates for surgical/percutaneous revascularization procedures (e.g., angioplasty, coronary bypass surgery).
To assess the effectiveness, and cost effectiveness of EECP in patients with heart failure.
Clinical Need
Angina
Angina is a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back or arm. Angina usually occurs in patients with coronary artery disease (CAD) involving ≥1 large epicardial artery. However it can also occur in people with valvular heart disease, hypertrophic cardiomyopathy, and uncontrolled hypertension.
Conventional approaches to restoring the balance between oxygen supply and demand focus on the disruption of the underlying disease through: drug therapy (β blockers, calcium channel blockers, nitrates, antiplatelet agents, ACE inhibitors, statins); life-style modifications (smoking cessation, weight loss); or revascularization techniques such as coronary artery bypass graft surgery (CABG) or percutaneous coronary interventions (PCI). (1) Limitations of each of these approaches include: adverse drug effects, procedure-related mortality and morbidity, restenosis after PCI, and time dependent graft attrition after CABG. Furthermore, an increasing number of patients are not appropriate candidates for standard revascularization options, due to co-morbid conditions (HF, peripheral vascular disease), poor distal coronary artery targets, and patient preference. The morbidity and mortality associated with repeat surgical revascularization procedures are significantly higher, and often excludes these patients from consideration for further revascularizations. (2)
Patients with CAD who have chronic ischemic symptoms that are unresponsive to both conventional medical therapy and revascularization techniques have refractory angina pectoris. It has been estimated that greater than 100,000 patients each year in the US may be diagnosed as having this condition. (3) Patients with refractory angina have marked limitation of ordinary physical activity or are unable to perform any ordinary physical activity without discomfort (CCS functional class III/IV). Also, there must be some objective evidence of ischemia as demonstrated by exercise treadmill testing, stress imaging studies or coronary physiologic studies. (1)
Dejongste et al. (4)estimated that the prevalence of chronic refractory angina is about 100,000 patients in the United States. This would correspond to approximately 3,800 (100,000 x 3.8% [Ontario is approximately 3.8% of the population of the United States]) patients in Ontario having chronic refractory angina.
Heart Failure
Heart failure results from any structural or functional cardiac disorder that impairs the ability of the heart to act as a pump.
A recent study (5) revealed 28,702 patients were hospitalized for first-time HF in Ontario between April 1994 and March 1997. Women comprised 51% of the cohort. Eighty-five percent were aged 65 years or older, and 58% were aged 75 years or older.
Patients with chronic HF experience shortness of breath, a limited capacity for exercise, high rates of hospitalization and rehospitalization, and die prematurely. (6) The New York Heart Association (NYHA) has provided a commonly used functional classification for the severity of HF (7):
Class I: No limitation of physical activity. No symptoms with ordinary exertion.
Class II: Slight limitations of physical activity. Ordinary activity causes symptoms.
Class III: Marked limitation of physical activity. Less than ordinary activity causes symptoms. Asymptomatic at rest.
Class IV: Inability to carry out any physical activity without discomfort. Symptoms at rest.
The National Heart, Lung, and Blood Institute (7) estimates that 35% of patients with HF are in functional NYHA class I; 35% are in class II; 25%, class III; and 5%, class IV. Surveys (8) suggest that from 5% to 15% of patients with HF have persistent severe symptoms, and that the remainder of patients with HF is evenly divided between those with mild and moderately severe symptoms.
To date, the diagnosis and management of chronic HF has concentrated on patients with the clinical syndrome of HF accompanied by severe left ventricular systolic dysfunction. Major changes in treatment have resulted from a better understanding of the pathophysiology of HF and the results of large clinical trials. Treatment for chronic HF includes lifestyle management, drugs, cardiac surgery, or implantable pacemakers and defibrillators. Despite pharmacologic advances, which include diuretics, angiotensin-converting enzyme inhibitors, beta-blockers, spironolactone, and digoxin, many patients remain symptomatic on maximally tolerated doses. (6)
The Technology
Patients are typically treated by a trained technician in a medically supervised environment for 1 hour daily for a total of 35 hours over 7 weeks. The procedure involves sequential inflation and deflation of compressible cuffs wrapped around the patient’s calves, lower thighs and upper thighs. In addition to 3 sets of cuffs, the patient has finger plethysmogram and electrocardiogram (ECG) attachments that are connected to a control and display console.
External counterpulsation was used in the United States to treat cardiogenic shock after acute myocardial infarction. (9;10) More recently, an enhanced version namely “enhanced external counterpulsation” (EECP) was introduced as a noninvasive procedure for outpatient treatment of patients with severe, uncontrollable cardiac ischemia. EECP is said to increase coronary perfusion pressure and reduce the myocardial oxygen demand. Currently, EECP is not applicable for all patients with refractory angina pectoris. For example, many patients are considered ineligible for therapy due to co-morbidities, including those with severe pulmonary vascular disease, deep vein thrombosis, phlebitis and irregular heart rhythms, and heart failure. (1)
Very recently, investigation began into EECP as an adjunctive treatment for patients with HF. Anecdotal reports suggested that EECP may benefit patients with coronary disease and left ventricular dysfunction. The safety and effectiveness of EECP in patients with symptomatic heart failure and coronary disease and its role in patients with nonischemic heart failure secondary to LV dysfunction is unclear. Furthermore, the safety and effectiveness of EECP in the different stages of HF and whether it is only for patients who are refractive to pharmacotherapy is unknown.
2003 Health Technology Assessment by the Medical Advisory Secretariat
The Medical Advisory Secretariat health technology assessment (originally published in February 2003) reported on the effectiveness of EECP for patients with angina and HF. The report concluded that there was insufficient evidence to support the use of EECP in patients with refractory stable CCS III/IV angina as well as insufficient evidence to support the use of EECP in patients with HF.
Review Strategy
The aim of this literature review was to assess the effectiveness, safety, and cost effectiveness of EECP for the treatment of refractory stable CCS III/IV angina or HF.
The standard search strategy used by the Medical Advisory Secretariat was used. This included a search of all international health technology assessments as well as a search of the medical literature from December 2002 to March 2006.
A modification of the GRADE approach (11) was used to make judgments about the quality of evidence and strength of recommendations systematically and explicitly. GRADE provides a framework for structured reflection and can help to ensure that appropriate judgments are made. GRADE takes into account a study’s design, quality, consistency, and directness in judging the quality of evidence for each outcome. The balance between benefits and harms, quality of evidence, applicability, and the certainty of the baseline risks are considered in judgments about the strength of recommendations.
Summary of Findings
The Cochrane and INAHTA databases yielded 3 HTAs or systematic reviews on EECP treatment (Blue Cross Blue Shield Technology Evaluation Center [BCBS TEC], ECRI, and the Centers for Medicare and Medicaid Services [CMS]). A search of Medline and Embase December 2005 – March 2006 (after the literature search cutoff from the most recent HTA) was conducted using key words enhanced external counterpulsation, EECP, angina, myocardial ischemia, congestive heart failure. This search produced 1 study which met the inclusion criteria. This level 4a study was inferior in quality to the RCT which formed the basis of the 2003 Medical Advisory Secretariat recommendation.
BCBS reviewed the evidence through November 2005 to determine if EECP improves health outcomes for refractory chronic stable angina pectoris or chronic stable HF. (12) BCBS concluded that the available evidence is not sufficient to permit conclusions of the effect of EECP on health outcomes. Both controlled trials had methodologic flaws (MUST EECP and MUST EECP quality of life studies). The case series and observational studies for both indications while suggestive of a treatment benefit from EECP have shortcomings as well.
On March 20 2006, CMS posted their proposed coverage decision memorandum for external counterpulsation therapy. (13) Overall, CMS stated that the evidence is not adequate to conclude that external counterpulsation therapy is reasonable and necessary for:
Canadian Cardiovascular Society Classification (CCSC) II angina
Heart failure
NYHA class II/III stable HF symptoms with an EF≤35%
NYHA class II/III stable HF symptoms with an EF≤40%
NYHA class IV HF
Acute HF
Cardiogenic shock
Acute MI
In January 2005, ECRI (14) stated that there was insufficient evidence available to draw conclusions about the long-term effectiveness of EECP, with respect to morbidity, survival, or quality of life, for any coronary indication (refractory angina, congestive heart failure, cardiogenic shock and acute MI).
GRADE Quality of the Studies
According to the GRADE Working Group criteria, the quality of the trials was examined (Table 1). (11)
Quality refers to the criteria such as the adequacy of allocation concealment, blinding and followup.
Consistency refers to the similarity of estimates of effect across studies. If there is important unexplained inconsistency in the results, our confidence in the estimate of effect for that outcome decreases. Differences in the direction of effect, the size of the differences in effect and the significance of the differences guide the decision about whether important inconsistency exists.
Directness refers to the extent to which the people interventions and outcome measures are similar to those of interest. For example, there may be uncertainty about the directness of the evidence if the people of interest are older, sicker or have more comorbidity than those in the studies.
As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence. (11)
GRADE Quality of Studies
Economic Analysis - Literature Review
No economic analysis of EECP was identified in the published literature.
Estimated Prevalence of Angina in Ontario
3,800 patients with chronic refractory angina:
The number of patients with chronic refractory angina in the US is estimated to be approximately 100,000 (4), this corresponds to about 3,800 patients in Ontario (3.8% × 100,000) with refractory angina.
3,800 patients × $7,000 Cdn (approximate cost for a full course of therapy) ~ $26.6M Cdn.
Estimated Prevalence of Heart Failure in Ontario
23,700 patients EF ≤ 0.35:
This estimate is from an expert (personal communication) at the Institute for Clinical Evaluative Sciences (ICES), where they examined a sample of echocardiography studies drawn from a diagnostic lab in 2001. They found that the prevalence of EF ≤ 0.35 was 8.3%, and if generalized to all patients undergoing echocardiography, there would be 23,700 patients.
23,700 patients with EF ≤35% × $7,000 Cdn ~ $166 M Cdn.
Conclusions
There is insufficient evidence to support the effectiveness and safety of EECP treatment for patients with refractory stable CCS III-IV angina or HF.
As per the GRADE Working Group, overall recommendations consider 4 main factors. (11)
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome.
The quality of the evidence.
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise.
Uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. (11) Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 2 is the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For angina and heart failure, the overall GRADE and strength of the recommendations is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $26.6 M Cdn or $166 M Cdn respectively while the cost-effectiveness of EECP is unknown and difficult to estimate considering that there are no high quality studies of effectiveness.
Overall GRADE and Strength of Recommendation (Including Uncertainty)
PMCID: PMC3379533  PMID: 23074496
20.  Simultaneous coronary artery bypass and carotid endarterectomy. Determinants of outcome. 
Texas Heart Institute Journal  1994;21(2):119-124.
From January of 1988 to May of 1993, simultaneous single-stage coronary revascularization and carotid endarterectomy was performed in 33 patients (mean age, 69 years). Thirty-one patients (94%) were in New York Heart Association class III or IV, 15 (46%) had unstable angina, and 7 (21%) were operated on because of evolving myocardial infarction. One or more previous myocardial infarctions were present in 18 patients (54%). Nineteen patients (58%) presented with neurologic symptoms, and 22 (67%) had severe bilateral carotid stenosis. Thirty (91%) had triple-vessel or left main coronary artery disease. Sequential reconstruction of the carotid artery followed by coronary artery bypass grafting was performed in all patients. In 4 cases, additional cardiac procedures were performed. Operative mortality (6%) was cardiac related. Perioperative morbidity included myocardial infarction in 1 patient (3%) and neurologic deficit in 6 (18%), with permanent functional impairment in 2 patients (6%). The stroke rate was higher in the bilateral than in the unilateral carotid stenosis group (22.7% vs 9.1%, p = 0.047). Previously completed stroke influenced the operative outcome (55.6% vs 4.2%, p = 0.003). Low ejection fraction (33.5% +/- 7.5% vs 52.8% +/- 3.5%, p = 0.03) and left main coronary artery disease (36% vs 5%, p = 0.03) also predicted postoperative neurologic complications. During a mean follow-up of 24.6 +/- 3.5 months, 3 patients died. The 5-year life-table survival rate was 85%. Eighty-nine percent of long-term survivors were free of cardiovascular disease symptoms. Our results show that the out come of simultaneous carotid endarterectomy/coronary artery bypass grafting in this high-risk population depends upon the preoperative absence or presence of completed stroke or bilateral carotid stenosis, upon the preoperative ejection fraction, and upon the extent of the left main coronary artery disease.
PMCID: PMC325145  PMID: 8061536
21.  Steroid management in giant cell arteritis 
The British Journal of Ophthalmology  2001;85(9):1061-1064.
AIM—Ocular involvement in giant cell arteritis (GCA) is an ophthalmic emergency which, if untreated, can progress to permanent blindness. There is little evidence in the literature to support current protocols for the acute treatment of GCA with steroids. The authors sought to review the effects of intravenous and oral steroids in GCA.
METHODS—This retrospective study reviewed the records of 100 consecutive patients with biopsy proved giant cell arteritis. 73 patients with visual loss who were treated at the Royal Victorian Eye and Ear Hospital (RVEEH) and St Vincent's Hospital were included in the final series. The authors studied the management of the patients in the first week after presentation, analysing types of treatment, dose, effect on visual acuity, and complications.
RESULTS—All the patients except one had visual loss due to anterior ischaemic optic neuropathy (AION). 17 patients (23%) had bilateral eye involvement. Visual acuity improved in 21 of 73 patients (29%) by a mean of two Snellen chart lines after commencement of steroids. There was an increased likelihood of improved vision in the group who had intravenous steroids (40%) compared with those who received oral steroids (13%). In all except four patients (95%) vision remained stable at 1 month review.
CONCLUSIONS—Prompt treatment of GCA with steroids leads to improvement of visual acuity in a significant number of cases. Intravenous steroids may offer a greater prospect of improvement compared with oral steroids. A prospective trial comparing intravenous with oral steroids is needed to validate these findings and would not expose elderly patients to unacceptable risks.


doi:10.1136/bjo.85.9.1061
PMCID: PMC1724128  PMID: 11520757
22.  Early results of coronary artery bypass grafting with coronary endarterectomy for severe coronary artery disease 
Background
Despite the existence of controversial debates on the efficiency of coronary endarterectomy (CE), it is still used as an adjunct to coronary artery bypass grafting (CABG). This is particularly true in patients with endstage coronary artery disease. Given the improvements in cardiac surgery and postoperative care, as well as the rising number of elderly patient with numerous co-morbidities, re-evaluating the pros and cons of this technique is needed.
Methods
Patient demographic information, operative details and outcome data of 104 patients with diffuse calcified coronary artery disease were retrospectively analyzed with respect to functional capacity (NYHA), angina pectoris (CCS) and mortality. Actuarial survival was reported using a Kaplan-Meyer analysis.
Results
Between August 2001 and March 2005, 104 patients underwent coronary artery bypass grafting (CABG) with adjunctive coronary endarterectomy (CE) in the Department of Thoracic-, Cardiac- and Vascular Surgery, University of Goettingen. Four patients were lost during follow-up. Data were gained from 88 male and 12 female patients; mean age was 65.5 ± 9 years. A total of 396 vessels were bypassed (4 ± 0.9 vessels per patient). In 98% left internal thoracic artery (LITA) was used as arterial bypass graft and a total of 114 vessels were endarterectomized. CE was performed on right coronary artery (RCA) (n = 55), on left anterior descending artery (LAD) (n = 52) and circumflex artery (RCX) (n = 7). Ninety-five patients suffered from 3-vessel-disease, 3 from 2-vessel- and 2 from 1-vessel-disease. Closed technique was used in 18%, open technique in 79% and in 3% a combination of both. The most frequent endarterectomized localization was right coronary artery (RCA = 55%). Despite the severity of endstage atherosclerosis, hospital mortality was only 5% (n = 5). During follow-up (24.5 ± 13.4 months), which is 96% complete (4 patients were lost caused by unknown address) 8 patients died (cardiac failure: 3; stroke: 1; cancer: 1; unknown reasons: 3). NYHA-classification significantly improved after CABG with CE from 2.2 ± 0.9 preoperative to 1.7 ± 0.9 postoperative. CCS also changed from 2.4 ± 1.0 to 1.5 ± 0.8
Conclusion
Early results of coronary endarterectomy are acceptable with respect to mortality, NYHA & CCS. This technique offers a valuable surgical option for patients with endstage coronary artery disease in whom complete revascularization otherwise can not be obtained. Careful patient selection will be necessary to assure the long-term benefit of this procedure.
doi:10.1186/1749-8090-4-52
PMCID: PMC2756249  PMID: 19772645
23.  Arterial end-to-side grafting in coronary artery bypass grafting: the Tector procedure 
Netherlands Heart Journal  2010;18(1):7-11.
Background. The current treatment of choice in patients with three-vessel coronary disease is coronary artery bypass grafting. The use of the left internal mammary artery in bypass grafting has shown superior long-term outcomes compared with venous grafting. In our study we assess the safety and feasibility of all-arterial coronary artery bypass graft surgery using the procedure as described by Tector et al. in 2001.
Methods. Between June 2001 and February 2007, we studied 133 patients eligible for non-emergency surgical revascularisation. Primary endpoints were death or re-infarction within a 30-day period. Secondary endpoints were the need for emergency coronary surgery, angioplasty and mediastinitis. Long-term follow-up had a mean duration of 33 months postoperatively.
Results. All 133 patients were successfully revascularised, 98% with the off-pump technique. In 93% of the patients (n=124) full arterial grafting was achieved using both internal mammary arteries. Thirty-day mortality was 1.5% (n=2), ten re-thoracotomies were performed, one myocardial infarction and one case of mediastinitis were reported. In the next four years six additional patients died. Most of these deaths were due to non-cardiovascular causes. Two patients required angioplasty because of distal bypass graft failure and one for new native coronary artery disease. Conclusion. All-arterial bypass grafting using both internal mammary arteries with the technique as described by Tector is safe and feasible without excess deep sternal wound infections. Late major adverse cardiac events are rare and due to distal graft dysfunction, which can be treated by percutaneous coronary intervention. (Neth Heart J 2010;18:7-11.)
PMCID: PMC2810029  PMID: 20111637
coronary artery disease; bypass grafting; angina; all arterial revascularisation; off-pump CABG
24.  Protocol for the Arterial Revascularisation Trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation [ISRCTN46552265] 
Trials  2006;7:7.
Background
Standard coronary artery bypass graft surgery uses a single internal mammary artery and supplemental vein or radial artery grafts. Several observational studies have suggested a survival benefit with two internal mammary artery grafts compared to a single internal mammary artery graft, but this has not been tested in a randomised trial. The Arterial Revascularisation Trial is a Medical Research Council and British Heart Foundation funded, multi-centre international trial comparing single internal mammary artery grafting versus bilateral internal mammary artery grafting.
Methods/Design
Twenty centres in the UK, Australia, Poland and Brazil are planning to randomise 3000 coronary artery bypass graft surgery patients to single or bilateral internal mammary artery grafting. Supplemental grafts may be either saphenous vein or radial artery. Coronary artery bypass grafting can be performed as an on-pump or off-pump procedure. The primary outcome is survival at 10 years and secondary end-points include clinical events, quality of life and cost effectiveness. The effect of age, left ventricular function, diabetes, number of grafts, vein grafts and off-pump surgery are pre-specified subgroups.
Discussion
The Arterial Revascularisation Trial is one of the first randomised trials to evaluate the effects on survival and other clinical outcomes of single internal mammary artery grafting versus bilateral internal mammary artery grafting, and will help to establish the best approach for patients requiring coronary artery bypass graft surgery.
doi:10.1186/1745-6215-7-7
PMCID: PMC1450314  PMID: 16573820
25.  Transient Visual Loss in a Hepatitis C Patient Treated With Pegylated Interferon Alfa-2a and Ribavirin 
Hepatitis Monthly  2014;14(2):e15124.
Introduction:
Patients with Hepatitis C are commonly treated with combination of Pegylated Interferon alfa-2a and Ribavirin. Less than 1% of patients receiving this treatment experience very uncommon ophthalmological side effects such as optic neuropathy and vision disorder, which are usually subclinical, mild and reversible, not requiring the withdrawal of the treatment. Retinopathy is the most commonly reported ocular side effect of interferon use, usually presenting with cotton wool spots and retinal hemorrhages.
Case Presentation:
We represent a case of severe retinopathy and optic neuropathy in a patient with chronic hepatitis C genotype 3a infection, treated with the combination of PEG-IFN alfa-2a (180 mkg once weekly) and Ribavirin (1200 mg daily). Bilateral visual loss of both eyes developed at 11th week of therapy and changes in retina and optic nerve were observed. Fluorescein angiography and optical coherence tomography showed bilateral anterior ischemic optic neuropathy and macular edema. Visual acuity improved 1 month and fundoscopic changes were no longer present 6 months after the urgent permanent discontinuation of PEG-IFN treatment and the pulse steroid therapy followed by a 2 week course of oral prednisone.
Discussion:
In case of interferon-associated retinopathy discontinuation of the therapy and treatment with high dose steroids can be beneficial. The prognosis of interferon-associated opthalmological side effects remains uncertain: in some patients visual acuity improves, other continues with poor visual outcome. Considering that, all patients should undergo ophthalmologic examination before treatment with interferon and their ophthalmological status should be monitored regularly while receiving this therapy.
doi:10.5812/hepatmon.15124
PMCID: PMC3950629  PMID: 24693308
Hepatitis C, Chronic; Peginterferon alfa-2a; Optic Nerve Diseases; Pulse Therapy, Drug

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