A Change in Myocardial Preservation Strategies using the Quest Medical MPS 2 System

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A Change in Myocardial Preservation Strategies using the Quest Medical MPS 2 System Jim MacDonald, CPC,CCP Clinical Perfusion Services, London Health Sciences Centre London, Ontario, Canada

Why the Change from variable ratio to the Quest MPS system A platform that would allow the flexibility to meet our demands today while allowing for future considerations. Potential to meet some of the perfusion best practice recommendations. Murkin et al, 2006

Process of Change? The time had come to proceed from discussion of philosophy and the theory of change to our clinical initiation of change merger process. Factors that influenced change: discussions with Quest Medical Inc, the experiences and clinical outcomes previously published, surgeons and perfusionists willingness to change, clinical observations of the MPS 2 System with the Clinical Perfusionists at the Toronto General Hospital.

A 46 year old female, Rheumatic fever at age 2 87kg, 155cm with a BSA of 1.94 Presented with dyspnea on fatigue, hypertension, chronic atrial fibrillation, suggestion of previous TIA. New York Heart Association class 3. Echocardiogram and TEE identified mitral valve regurgitation, mitral valve stenosis plus aortic stenosis and insufficiency secondary to rheumatic heart disease. She was scheduled for replacement of Aortic and Mitral Valve.

Equipment Used A Jostra HL 20 Heart Lung Machine. Terumo SX25 Oxygenator. Quart Arterial Line Filter. Newly acquired Quest MPS cardioplegia delivery system

Surgical Course A clean arch noted by TEE prior to cannulation. Aortic cannulation, bicaval venous cannula Retrograde cardioplegia into coronary sinus confirmed with TEE Initiation of extracorporeal circulation followed by delivery of cardioplegia via the Quest MPS system.

Surgical Course The aorta was opened and cardioplegia delivered antegrade via hand held cannula into the coronary ostia. Once satisfactory arrest was established attention was given to the rheumatic mitral valve. Which was replaced with a 25mm St.Jude Mechanical valve The mitral valve was seated uneventfully and attention was then given to the Aortic Valve. Myocardial protection maintained via intermittent doses of retrograde cardioplegia

Surgical Challenges The Aortic Valvectomy was then performed and it became evident the sino tubular diameter of the patient was quite small. A 23 mm sizer was able to be inserted and hence a 23 St Jude valve was selected and brought into place. Upon seating the left side of the aortic valve it became evident that the right coronary ostia could not be visualized thus the valve could not be seated and was removed.

Challenges Continue 21mm St Jude valve was then selected and sutured into place. Upon attempting to seat the valve issues with size the sino tubular junction created seating challenges once again! The aortotomy was then extended through the sinotubular ridge down to the non coronary sinus the valve was removed and new sutures placed and the valve was then seated. Myocardial preservation maintained throughout with intermittent doses of cardioplegia during the entire seating of the valve

Surgical Challenges The aortotomy was then closed under protection of retrograde cardioplegia De airing was performed with the patient in trendelenburg. Antegrade cardioplegia was then given to test the suture line of the aortotomy which required reinforcing.

Surgical Outcomes A cross clamp time of 4 hours and 30 minutes. 15 infusions of microplegia for a total of 16,129 cc s via the MPS system. The patient resumed normal sinus rhythm shortly after the removal of the cross clamp. During the case Glucose and K + levels within normal limits. The patient was transferred to the Intensive care unit in a stable condition with minimal Intropic support.

Results that impressed us with this case report Normal glucose levels were maintained over this time frame. No need for Hemoconcentration during the case. Return of spontaneous rhythm shortly after removal of the cross clamp. The patient was successfully weaned from extracorporeal circulation with minimal intropic support and without the need of an IABP.

Cardioplegia Challenges at LHSC Merger of 2 hospitals with 3 different solutions Crystalloid 2 different variable ratio solutions Cold intermittent Continuous normothermic

In all my work I have tried to embody the passionate conviction the world of ideas and the world of action are not separate as some would have us think, but inseparable parts of each other. Ideas in particular, are truly potent forces that shape the world Avedis Donabdian The incorporation of new technology into practice is not a trivial matter but none the less critical for ensuring evidence based practices. The link between scholarly work and putting it into action is the responsibility of the provider. It is also the responsibility of the provider to have a means to evaluate the change. This is critical for evidence based practice. Likosky J. Extra Corpor Technol.2006;38:297 301

An evidence based review of the practice of cardiopulmonary bypass in adults: A focus on neurological injury, glycemic control, hemodilution and the inflammatory response. Shann et al Journal of Thoracic and Cardiovascular Surgery. Aug 2006 Maintenance of Euglycemia. Murkin There is both experimental and clinical evidence that hyperglycemia is associated with exacerbation of neurological injury and a variety of other adverse outcomes including wound infection and mortality. Hemodilution Defoe and colleuges. Patients undergoing a single HCT value of 19% or less during CPB had twice the mortality as those who had a HCT of 25%. Significant association with intraoperative or post operative placement of an IABP.

Theories of Microplegia Reduced myocardial edema Reduced systemic hemodilution Improved metabolic and systemic recovery Better 0 2 delivery and buffering capacities Improved K+ and glucose control Reduced transfusion rates??? Distribution (Menasche, 1996)

Learning curves Hyperglycemia is no longer an issue Its all about the additive Normothermic continuous cardioplegia was the greatest challenge with breakthrough beating, despite high K + levels We have contacted at least 10 institutions

LHSC Formula 50cc syringe 15cc D50 8cc Nacl 15u insulin 100mg xylocaine 10cc MgSO4 6mg Adenocard At 5cc Delivers/liter 1.5cc (750mg) 2cc 1.5 units 10 mg 2.0 gm 0.6 mg

Intraoperative Blood Conservation Techniques During CPB: Have We Reached A Plateau Ralley F, Allen P, McKay C, Quantz M, & Berta D. Poster presentation at SABM Annual Meeeting; Sept 6 9, 6 2007 ; Hollwood California. Retrospective analysis 230 patients undergoing elective/urgent cardiac surgery Aortic procedures, patients with a preoperative hgb 100g/L or less were excluded Demographic data, CPB transfusion rates, use of IABP, use of ultrafiltration were recorded. 6 weeks prior to the Quest MPS vs 6 weeks after the institution of the MPS (allowing for a 2 week training period)

Demographics Demographics P Values 0 20 40 60 80 100 120 140 BMI * PreOp Hgb Low Hgb CPB (min) X/C (min) * Ratio C/P MPS.009 71.9 (32.1) 59.0 (30.2) X/C (min).212 107.7 (40.2) 99.7 (42.7) CPB (min).784 83.3 (13.2) 82.7 (12.9) Low Hgb.811 137.8 (14.6) 137.3 (14.3) Pre Op Hgb.027 28.4 (4.2) 30.7 (6.9) BMI P value MPS Ratio C/P

Results 6000 P values 5000 4000 Ratio C/P MPS P value 3000 2000 Ratio C/P MPS Total C/P (mls) 4618.8 (3821) 5251.7 (4028).303 1000 Crystalloid (mls) 688.4 (428.5) 61.1 (31.0) <.001 0 Total C/P (mls) Cryst. * (mls)

RBC Transfusion & U/F P values 45 40 Ratio C/P MPS P value 35 # of patients Transfused with RBC s # of patients requiring U/F 10/79 12.7% 35/79 44.3% 11/87 12.6% 20/87 23.0%.998.004 30 25 20 15 10 5 0 % Pts RBC % Pts U/F * Ratio C/P MPS

Utilization of IABP 4 month period prior to and post initiation of Quest MPS. # pts requiring IABP Ratio C/P 27/369 7.3% MPS 19/402 4.7% P value 0.17 8 7 6 5 4 3 2 1 0 7.3 4.7 % pts requiring IABP Ratio C/P MPS

Points of Clinical Interest Decrease in use of hemoconcentration during CPB. Greater control of glucose and potassium during CPB. Early findings have shown a trend (36%) toward decrease in IABP. 97% of patients who required an IABP received RBC transfusion. 53% of the patients who required an IABP received >4 units of PRBC

In Retrospect! Did this change in myocardial startegies follow the guidelines of a local quality improvement project as well as tracking our practice as it relates to evidence based best practices? Could we have been more structured in our transition from theory into clinical practice? Have we been successful in enchancing our standard of clinical practice as it relates to evidence based guidelines?

In Conclusion In our experience to date, the change to the MPS has provided us the ability to address a number of areas of concern for our patients that reach beyond myocardial protection which are consistent with best practice. Special thanks to the team back home

Adds small titrations of myocardial protecting and arresting agents to achieve an aerobic diastolic arrest during cardiac surgery.

MPS Draws blood from the arterial line of the extra corporeal circuit. Uses Piston Pumps to deliver undiluted blood, arresting agents and additive solutions through the system.

Demographics 140 120 100 80 60 40 Ratio MPS 20 0 #pts hbg bmi X clamp CPB

Additional examples of high volume CP Procedure C/P Amount Crystalloid (mls mls) X clamp time (min) Blood Product s IABP U/F K + Range mmol/l Gluc. Range mmol/l AVR/Cabg 17.1 L 108 ml 88 None No No 4.0 6.0 4.3 6.2 Redo MVR 22.7 L 200 ml 103 3 No Yes 4.2 7.1 7.0 12.6 Bentall/Cabg 22.6 L 174 ml 201 None No Yes 4.6 5.8 5.9 7.0 AVR 15.5 L 123 ml 76 None No No 4.3 6.9 6.1 8.4 Bentall 29 L 1150 ml 117 None No Yes 3.9 5.5 3.4 13.0 MVR/AVR 16.1 L 200 ml 270 4 No No 5.1 7.5 5.7 9.4

Results of study Hbg 8.2 vs 8.3 # Units 3 vs 2 #uf 44/95 vs 24/97 %IABP 7.3 vs 4.7 45 40 35 30 25 20 15 10 5 0 <hbg units ufilter IABP Ratio MPS

Intraoperative Blood Conservation Techniques During CPB: Have We Reached A Plateau Ralley et al poster presentatin at SABM Annual Meeeting; ; Sept 6 9, 6 2007 ; Hollwood California. Retrospective analysis 230 patients undergoing elective/urgent cardiac surgery Aortic procedures and patients with a preoperative hbg 100 or less were excluded Demographic data, CPB data transfusion rates, use of IABP, use of ultrafiltration were recorded. 6 weeks prior to the Quest MPS vs 6 weeks after the institution of the MPS (allowing for a 2 week training period)

Points of Interest Ratio C/P group: Longer CPB times were associated with RBC transfusions (p =.014 and.017 multivariable analysis) Ratio C/P group: U/F associated with RBC tx (p =.027) MPS group: U/F not associated with RBC tx (p =.267) Early findings have shown a 36% decrease in IABP requirements. 97% of patients who required an IABP received RBC transfusion. 53% of the patients who required an IABP received >4 units of PRBC

Conclusions No change in transfusion rates to date Gained tighter ranges in K + and glucose levels Reduced U/F Trend towards reduced IABP utilization

Quest Microplegia System MPS The MPS utilizes the theory that enhanced myocardial protection is offered by limiting the dilution load to only the drugs delivered, thus reducing myocardial edema and associated hemodilution. Oxygen delivery is enhanced as a result of the higher hct of the cardioplegia perfused.