The Journal of Thoracic and Cardiovascular Surgery



Study protocolTitle: Clinical aspects of the del Nido cadioplegia use in isolated aortic valve surgery- 30-day observation.(the del Nido cardioplegia versus cold blood cardioplegia in aortic valve surgery)List of contentsOverview..…………………………………………………………………..……………………………………………………………3Signature site……………..…………………………………………………………………………………………………………….…….4Introduction …………….…………………………………………………………………………………………………………………..5Aims ………………………...............................................................................................................................7Sample size……………………….……………………..………………………………………………………………………………………..8Study design……………..............................................................................................................................9Procedures …………………………….............................................................................................................. 9Hospital admission................................................................................................... 9Surgical procedure ...........................................................................................................9Perioperative period ……………………………........................................................................1030-day clinical evaluation…………. ...................................................................................10Study endpoints …….………………………………............................................................................................10Appendix I Procedural form………….…………….....................................................................................................12Appendix II Definitions .......................................................................................................................................13Appendix IIIPatient information and informed consent form (original Polish version)......................................14Informed consent form……………..………………………………………………………………………………………….,.…..18Appendix IV Declaration of Helsinki…..………………………………………………………………………………………………………….. 19References…………...……………….................................................................................................. 25Overview: Study modelSingle-centre clinical trialResearch centreAmerican Heart of Poland, 1st Department of Cardiac SurgeryAllocationRandomizedPatient numberN=150 (75 in the del Nido cardioplegia group; 75 in the control group)Study durationStudy start date01.06.2016Estimated completion date31.06.2018Inclusion criteriaQualification for isolated aortic valve replacement procedureAge> 18 y.o.Given informed consentExclusion criteriaReoperationAllergy to lidocainePorcelain aortaCoronary artery disease requiring surgical or percutaneous interventionPregnancyEjection fraction<30%Clinical observationHospitalization30-day clinical evaluationStudy endpointsThe primary endpoint includes: -electrical cardiac activity during cross-clamp -ventricular fibrillation during reperfusion-postoperative troponin and creatinine kinase (MB isoenzyme) values at 24h and 48h.The secondary endpoint includes:-ventricular fibrillation during the cardioplegia administration-time from the beginning of cardioplegia administration to cardiac arrest-procedural use of the pacemaker-intraoperative myocardial infarction-new Q waves or LBBB in the perioperative period-fall (>5%) of the ejection fraction in the perioperative period-low cardiac output syndrome-use of the intraaortic balloon pump-perioperative atrial fibrillation-perioperative arrhythmia (other than AF)-postoperative blood product transfusion -perioperative creatinine values and kidney injury-gasometry parameters (pH, lactate, electrolytes, haematocrit, glucose)-use of continuous veno-venous hemodiafiltration-death from any cause in 30-day observation-cardiac death in 30-day observationPrincipal investigatorMarek Cisowski, MD, PhDProtocol signature siteTitle: Clinical aspects of the del Nido cadioplegia use in isolated aortic valve surgery- 30-day observation (the del Nido cardioplegia versus cold blood cardioplegia in aortic valve surgery)Version: 1.0 z from 14.06.2016I have read, accepted and signed the entire protocol:Principal investigator:Signature:…………………………………………..Date:………………………………………………Name: Marek CisowskiAcademic degree : MD; PhDINTRODUCTIONSurgical procedures that are performed on an open heart, with the use of extracorporeal circulation, require adequate myocardial protection. Inadequate protection may lead to myocardial stunning, cell apoptosis and myocardial infarction.A cardioplegia solution reduces myocardial metabolism to prevent intracellular acidosis and calcium ion accumulation during the ischemia. The effect is achieved through cellular membrane depolarization and diastolic myocardial arrest due to high extracellular potassium concentration. The aim is to mitigate the ischemia-reperfusion injury.The techniques of myocardial protection are constantly developed and improved. The cold blood cardioplegia is currently one of the most widely used cardioplegia protocols across the world. The solution contains blood and a crystalloid component in a 4:1 ratio. There are several protocols of preparing the cold blood cardioplegia, but primary protective mechanism is the same- the depolarized arrest caused by high concentration of potassium ions prevents the myocardial injury. Component:Volume [ml]:Mechanism:Plasma-Lyte A 435Base solution (Na 140mmol/l;K 5mmol/l;Mg 3mmol/l;pH 7,4)Mannitol 15%20Osmotic pressure, free radical scavengerNaHCO3 1mEq/ml20pH bufferKCl 2mEq/L25Myocardial depolarizationTab.1 The 4:1 cold blood cardioplegia solution crystalloid component used at 1st Department of Cardiac Surgery, AHPThe temperature of the cardioplegia is 4-12 degrees Celsius (?cold”) and the blood is mixed with crystalloid component in a 4:1 ratio (”blood”). The advantages of the protocol are: highly oxygenated conditions, preventing haemodilution, high buffering capacity, optimal osmotic parameters, physiological pH values and electrolyte balance, presence of endogenous free radical scavengers. The cardioplegia should be administered every 20 minutes throughout the procedure.The del Nido cardioplegia model was primarily designed as a paediatric cardiac surgery cardioprotection protocol. The history of the solution reaches 1990 when it was designed by Pedro del Nido and his team at the University of Pittsburgh. The crystalloid component is mixed with blood in a 4:1 ratio. A single use of 20ml/kg dose ensures satisfactory protection for a period of 90 minutes Component:Volume [ml]:Mechanism:Plasma-Lyte A 1000Base solution (Na 140mmol/l;K 5mmol/l;Mg 3mmol/l;pH 7,4)Mannitol 20%16.3Osmotic pressure, free radical scavengerMgSO4 50%4Calcium channel blocker, prevents contractile activityNaHCO3 1mEq/ml13pH bufferKCl 2mEq/L13Myocardial depolarizationLidocaine 1%13Sodium channel blocker, prevents electrical activityTab2. The del Nido cardioplegia crystalloid component, mixed with blood in a 4:1 ratioWhat is important, there are no calcium ions in the crystalloid component. The only source of calcium ions in the del Nido cardioplegia protocol is autologous blood additive (20% volume).Mannitol is a free radical scavenger and has osmotic capacity, which reduces cellular oedema. The magnesium ion is a natural calcium blocker- it reduces intracellular calcium accumulation during the ischemia. Furthermore, it improves ventricular muscle regeneration [1-2]. Sodium bicarbonate has high pH buffering capacity. The potassium ions ensure cellular depolarization and lead to diastolic cardiac arrest. The potassium concentration in the del Nido cardioplegia is estimated to be higher than in the cold blood cardioplegia (24 mEq/L).The depolarized arrest is efficient, but does not successfully prevent intracellular calcium accumulation, which is believed to be one of the most important factors determining ischemia-reperfusion injury [3]. The del Nido cardioplegia designers addressed this problem by adding the lidocaine into the crystalloid component. The lidocaine blocks sodium channels and reduces sodium influx and calcium accumulation. The blood additive ensures oxygenated environment and improves coronary perfusion during the cardioplegia administration [4]. The animal model (Langendorff isolated rat heart; both young adult and old) provided information about superiority of the del Nico cardioplegia when compared to the blood cardioplegia in terms of: spontaneous electromechanical myocardial activity throughout the cross-clamp, presence of tachyarrhythmia after declamping the aorta, coronary perfusion after declamping the aorta, cardiac output after the reperfusion, biomarker values, cellular oedema [5]. There are several reports of using the del Nido cardioplegia in adult patients [6-7]. However, there are no clinical randomized trials.The absence of electrical or electromechanical activity after the cardioplegia administration (during the cross-clamp) is one of the most direct measurements evaluating the cardioprotection efficiency. The animal model shows superiority of the del Nido cardioplegia in this matter (88% cold blood vs 13% del Nido in the aged hearts; 33% vs 0 % in the young adult hearts) [5].The electromechanical heart activity after declamping the aorta provides valuable information about the extent of ischemia-reperfusion injury. Pehkonen EJ et al. reported that only 26% patients undergoing aortic valve procedure regained primary heart rhythm after declamping the aorta [8]. The ventricular fibrillation during reperfusion is not rare. The arrythmia has negative effect on the coronary perfusion and results in a depletion of myocardial energy reserves [9]. The occurrence of ventricular fibrillation during reperfusion is related to metabolical and biochemical disturbances, which are consequence of energy substrate depletion despite the reduction of subendocardial perfusion and intracellular acidosis [10-13]. Sequential defibrillations even extend the damage [14-15]. The ventricular fibrillation after removing the cross-clamp is estimated to occur in 46.43% valvular procedures with the use of the cold blood cardioplegia [16]. The animal model study showed the superiority of the del Nido cardioplegia in both young adult (0 vs. 17%) and aged hearts (12.5% vs 50%). However, the statistical significance was not shown [5].Not surprisingly, the animal model study underlined that the initial rhythm during reperfusion returned faster in the cold blood cardioplegia group [5]. The difference is visible in both young adult and aged hearts. The superiority of the del Nido cardioplegia in terms of myocardial oedema reduction was statistically insignificant. It seems justified to analyse the frequency of the bradycardia with the use of temporary pacemaker and necessity to implant a permanent pacemaker. The irreversible atrioventricular block requiring pacemaker implantation is estimated to occur in 3.2% patients after aortic valve surgery [17]. The postoperative myocardial damage, including myocardial infarction, is highly related to the efficiency of the cardioprotection model. The difference in the TnI release in the animal studies was statistically significant in aged hearts (0.24 ± 0.05 ng/ml in the del Nido groups vs 0.89 ± 0.23 ng/ml in the blood cardioplegia group) and insignificant in young adult hearts (0.67 ± 0.24 ng/ml in the del Nido group vs 1.44 ± 0.38 ng/ml in the blood cardioplegia group) [5]. The human studies do not show statistical significance in this matter [18]. However, analysis of biomarker release, ECG changes and contractility changes should be one of the most important components of randomized, clinical trial.It is worth mentioning that the del Nido cardioplegia animal subjects revealed higher cardiac output when compared to classical blood cardioplegia in aged heart group [5]. The difference was not shown in the young adult heart group. Current human reports regarding the use of the del Nido cardioplegia point at the difference with the use of inotropes in perioperative period (20.4% del Nido; 24.1% blood cardioplegia) with no statistical significance [19]. It may be important to perform investigation towards the low cardiac output syndrome in a randomized group of patients.Perioperative and postoperative arrhythmia are frequent complications following the valvular heart surgery. There are studies reporting lower incidence of perioperative atrial fibrillation and other arrhythmia in the del Nido cardioplegia group with no statistical significance [20].The risk of haemodilution remains one of the concerns when using a crystalloid cardioplegia. It may be important to perform investigation towards perioperative haematocrit values and need for blood product transfusion, as some studies report higher incidence of transfusion in the crystalloid cardioplegia groups [21].Robert A. Sorabella et al. [20] compared the incidence of perioperative kidney injury in patients undergoing aortic valve reoperation and pointed at better results in the del Nido cardioplegia group. The statistical significance was not shown. It is indicated to conduct the analysis on a randomized patient cohort.AimsThe aim of the study is to answer the primary research question:Do patients undergoing aortic valve replacement benefit from using the del Nido cardioplegia instead of the cold blood cardioplegia?The answer to the question and complex analysis towards primary and secondary endpoints shall provide valuable information regarding the use of the del Nido cardioplegia. The patients undergoing aortic valve surgery and any other heart surgery may benefit from the study conclusions. Sample sizeCategorical data (chi-square test)The absence of spontaneous electrical and electromechanical myocardial activity after the cardioplegia administration (during the cross-clamp)- allows to evaluate the efficiency of the cardioprotection model. The animal model shows superiority of the del Nido cardioplegia in this matter (88% cold blood vs 13% del Nido in the aged hearts; 33% vs 0 % in the young adult hearts). If applied for the current study, required total sample size (equal samples for both groups) at 0.95 confidence level and 80% power would be 12 (88% vs 13%) or 38 (33% vs 0%) respectively. Ventricular fibrillation - the ventricular fibrillation after removing the cross-clamp is estimated to occur in 46.43% valvular procedures with the use of the blood cardioplegia [16]. The animal model study showed the superiority of the del Nido cardioplegia in both young adult (0 vs. 17%) and aged hearts (12,5% vs. 50%). If applied for the current study, required total sample size (equal samples for both groups) at 0.95 confidence level and 80% power would be n= 84 (0 vs 17%) or n= 46 (12.5% vs 50%) respectively.Continuous data (independent samples t test with assumption of unequal variances)Biomarker (troponin and CK-MB) release- the difference in the TnI release in the animal studies was statistically significant in aged hearts (0.24 ± 0.05 ng/ml in the del Nido groups vs 0.89 ± 0.23 ng/ml in the blood cardioplegia group) and insignificant in young adult hearts (0.67 ± 0.24 ng/ml in the del Nido group vs 1.44 ± 0.38 ng/ml in the blood cardioplegia group) [5] . If applied for the current study, required total sample size (equal samples for both groups) at 0.95 confidence level and 80% power would be n= 6 or n= 8 respectively.Study designAll the procedures will be conducted after gaining the approval of the local Bioethics Committee and obtaining the consent from each patient.The study was designed as a prospective registry of 150 patients undergoing isolated aortic valve replacement, randomized into either del Nido cardioplegia group or into the cold blood cardioplegia group. It is a homogenous group of patients that should unequivocally describe the differences in the use of cardioplegia models. The programme is prepared for the patients that have no contraindications for the use of any of two models of cardioplegia (see exclusion criteria)Proceduresa) Hospital admission-patient information and obtaining the informed consent form signature-clinical evaluation-lab tests (morphology, electrolytes, creatinine values, CK-MB, hs troponin T)-echocardiography-preoperative anaesthesia consultation-ECGb) Surgical procedure- the procedure will be conducted with reference to actual standards and guidelines. A general anaesthesia will be induced. Before the anaesthesia, invasive blood pressure monitoring (preferably right radial artery) will be obtained. After the intubation, central venous access shall be introduced (preferably right jugular access). The echo probe will be passed into the oesophagus to evaluate morphology and flow parameters of the aortic valve. The Foley catheter will be passed into the bladder.The medial sternotomy will be used for surgical access. The evaluation of the ascending aorta will be performed before the cannulation. If no massive calcifications are present (the ?porcelain aorta”), the patient will be randomized and the heparin will be given in a dose adjusted to patient’s body mass. The cannulation will be performed in a standard technique (aortic cannula in the ascending aorta; two-stage venous cannula in the right atrium). A vent will be passed into the left ventricle through left superior pulmonary vein and the mitral valve. The extracorporeal circulation will start when the activated clotting time (ACT) exceeds 480 seconds. The cardioplegia (del Nido or cold blood, depending on the randomization) will be administered antegrade into the aortic bulb or directly through the coronary ostia if aortic regurgitation is present. After the aortotomy, evaluation of the native aortic valve will be conducted and the replacement procedure (mechanical valve or bioprosthesis) will be performed. Single felt-pledget sutures will be used for the valve implantation. The carbon dioxide will be inflated into the operating field until the aortotomy is closed. The cold blood cardioplegia doses will be repeated every 20-30 minutes; the del Nido cardioplegia will be given in a single dose unless the cross-clamp time exceeds 90 minutes. The aortotomy will be sutured with single- or double-layer continuous suture. Before the cross-clamp removal deairing manoeuvres will be performed. After declamping the aorta, myocardial contractility, effectiveness of deairing manoeuvres and proper valvular function will be evaluated in a transoesophageal echocardiography. When hemodynamic parameters are stable, the patient will be weaned from cardiopulmonary bypass. Venous and arterial cannulas will be removed. The heparinization will be reversed with protamine sulphate. Two epicardial electrodes and one or two chest tubes will be introduced. The chest will be closed after obtaining satisfactory haemostasis. The procedural form (appendix I) will be filled throughout the procedure.c) Perioperative period- after the procedure, the patient will be transferred to the postoperative ward. Constant monitoring of the chest drainage, blood pressure and diuresis will be conducted. The blood test panel (morphology, creatinine, electrolytes, tropoinin, CK-MB) and x-ray will be obtained. The blood gasometry will be performed every hour in the first 24 hours and every 6 hours in the second 24 hours. The chest tube will be removed 24 hours after the procedure and the chest x-ray will be repeated. The patient will be transferred to daily surgical ward 48 hours after the procedure.Following interventions and procedures will take place when appropriate. The patient will have echocardiographic examination, blood test panel, ECG at the day of the discharge. The pharmacotherapy will be adjusted individually. Patients who receive mechanical valve will be given vitamin K antagonist (acenocoumarin or warfarin) with a target INR in a range of 2.5-3.5 and low-weight molecular heparin until the INR >2. The patients who receive bioprosthesis will be given acetylsalicylic acid in a dose of 150mg daily, unless any other indications for anticoagulation are present. e) 30-day clinical evaluation- the physical examination, ECG and lab tests will be conducted.Study endpointsThe primary endpoint includes: -electrical cardiac activity during cross-clamp -ventricular fibrillation during reperfusion-postoperative troponin and creatinine kinase (MB isoenzyme) values at 24h and 48h.The secondary endpoint includes:-ventricular fibrillation during the cardioplegia administration-time from the beginning of cardioplegia administration to cardiac arrest-procedural use of the pacemaker-intraoperative myocardial infarction-new Q waves or LBBB in the perioperative period-fall (>5%) of the ejection fraction in the perioperative period-low cardiac output syndrome-use of the intraaortic balloon pump-perioperative atrial fibrillation-perioperative arrhythmia (other than AF)-postoperative blood product transfusion -perioperative creatinine values and kidney injury-gasometry parameters (pH, lactate, electrolytes, haematocrit, glucose)-use of continuous veno-venous hemodiafiltration-death from any cause in 30-day observation-cardiac death in 30-day observationAppendix I- Procedural formName……………………………………………..Surname…………………………… Documentation number…………………The cardioplegia__cold blood 4:1__del Nido __Haemofilter__BiopumpCardioplegia administration __aorta__ coronary ostia first dose:………………….Time from cardioplegia administration start to the cardiac arrest…………….. __ventricular fibrillation during administrationCross-clampSpontaneous electrical or electromechanical activity __YES __NO__SINGLE IMPULSE__SERIES OF IMPULSES__ Ventricular fibrillationCross-clamp removalTime from cross-clamp removal to the rhythm return (min)………….. (if no arrhythmia)Heart rate (/min)……………..__Ventricular fibrillation__Ventricular tachycardia__Atrial fibrillation_ Bigeminy __other- describe?............Cardioversion__YES_ NODefibrillation__ YES __NONumber of defibrillations__1__2__3__>3Cordarone__YES__NO__bradycardia <60__atrioventricular block__pacemakerReperfusion time (min)………………Gasometry after the cross-clamp removalpH………Na.........K……..Ca……..Hct………Glu……..Lac……..Extracorporeal circulation time (min)…………..Cross-clamp time (min)………….Total cardioplegia dose………………….__1 adm. __2 adm. __3 adm.__>3Additional information…………………………………………………………………………………………………………………………………………Appendix II- DefinitionsCardiac death- any death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia). Death from an unknown cause will be considered a cardiac deathPerioperative myocardial infarction- according to the Third Universal Definition of Myocardial Infraction [22], it is justified to use the same criteria for myocardial infarction in both CABG and other cardiac procedures. For the diagnosis cTn values should exceed 10 x 99th percentile URL during the first 48 h following the procedure, occurring from a normal baseline cTn value (≤99th percentile URL). In addition, either (I) new pathological Q waves or new LBBB, or (II) angiographically documented new graft or new native coronary artery occlusion, or (III) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, should be considered as diagnostic of a procedural-related MILow cardiac output syndrome- the most common definition of LCOS includes decreases in the cardiac index (CI) to 2.0 L/min/m2 and a systolic blood pressure of 90 mmHg, in conjunction with signs of tissue hypoperfusion (cold periphery, clammy skin, confusion, oliguria, elevated lactate level) in the absence of hypovolemia. Patients requiring only small doses of dopamine (<3 μg/kg) and patients who have catecholamine support for a raise of peripheral vascular resistance with the presence of normal or high cardiac output (≥2,5l/min/m2) are excluded from this groupAcute kidney injury- the creatinine elevation >25% or >0.5mg/dl in any of the tests was considered significant and described as kidney injury.Acute renal failure- according to the RIFLE [23], acute renal failure is defined as a three-fold increase of serum creatinine or decrease in GFR of >75% or a urine output of <0.3 ml/kg per h for >24 h or anuria for >12 h. Alternatively, failure also is defined by a serum creatinine of >4 mg/dl (353.6 μmol/L) with an acute rise of 0.5 mg/dl (42.2 μmol/L).Appendix III- Patient information and informed consent form (original Polish version)Imi? i nazwisko lekarza prowadz?cego ……………………………………………………….……… Nazwa o?rodka prowadz?cego: I Oddzia? Kardiochirurgii, American Heart of Poland, Bielsko-Bia?aINFORMACJE O CELU I SPOSOBIE PRZEPROWADZENIA BADANIAPana/Pani lekarz (nazywany tutaj ?lekarzem prowadz?cym badanie”) prosi Pana/Pani? o wzi?cie udzia?u w badaniu, którego celem jest porównanie dwóch stosowanych w praktyce klinicznej roztworów kardiopleginy.W trakcie, oraz po badaniu, nie zostan? opublikowane ?adne informacje, które umo?liwi?yby Pana/Pani identyfikacj?, lecz najwy?ej podsumowanie wyników badania. Niniejszy dokument to ?Informacja dla Pacjenta i Formularz ?wiadomej zgody”; zawiera informacje na temat tego badania, ryzyka, mo?liwych korzy?ci oraz Pana/Pani praw, o ile zgodzi si? Pan/Pani na wzi?cie udzia?u w tej próbie badawczej. Prosz? przeczyta? niniejszy formularz uwa?nie i w ca?o?ci. Je?eli ma Pan/Pani pytania lub czego? nie rozumie, prosz? zapyta? si? swojego lekarza prowadz?cego badanie. INFORMACJE WPROWADZAJ?CEZabieg, któremu zostanie Pan/Pani poddana jest przeprowadzany przy zatrzymanej akcji serca. Jego funkcja jest przejmowana przez maszyn? do kr??enia pozaustrojowego. W trakcie zatrzymania akcji serca musi by? ono chronione przed chemicznym uszkodzeniem powstaj?cym w trakcie beztlenowych szlaków metabolicznych.W tym celu stosuje si? roztwory zwane kardioplegin?. Powoduj? one zatrzymanie serca w rozkurczu i chroni? go przed patologicznymi zmianami podczas zabiegu. Na ca?ym ?wiecie stosuje si? kilka rodzajów kardiopleginy, ka?dy charakteryzuje si? pewn? specyfik?. Rodzaj zastosowanej karidopleginy nie ma wp?ywu na plan zabiegu i ca?okszta?t techniczny procedury operacyjnej. Jedyn? zmieniaj?c? si? komponent? jest sk?ad roztworu podawanego do naczyń wieńcowych w celu ochrony serca oraz zmienne odst?py czasowe pomi?dzy jego kolejnymi podaniami, charakterystyczne dla ka?dego z roztworów.Przedstawiony Panu/Pani projekt ma za zadanie porównanie ?ródzabiegowych parametrów oraz przeprowadzenie 30-dniowej obserwacji u chorych, u których podano dwa ró?ne rodzaje kardiopleginy. Jak dotychczas nie wykazano jasnej przewagi któregokolwiek z nich w zabiegach z powodu Pana/Pani choroby, obydwa s? z powodzeniem stosowane w o?rodkach kardiochirurgicznych na ca?ym ?wiecie.Po zabiegu b?dzie Pan/Pani monitorowany i poddany ?cis?ej obserwacji w trakcie pobytu wewn?trzszpitalnego, podobnie jak wszyscy pacjenci po zabiegu nieb?d?cy obj?ci badaniem. Podobnie jak u wszystkich pacjentów pooperacyjnych zapewniona jest kontrola lekarska 30 dni po zabiegu.PROCEDURAJak ju? wy?ej wspomniano, przeprowadzona u Pana/Pani procedura zabiegowa nie b?dzie ró?ni?a si? od standardowego post?powania w chorobach zastawki aortalnej, jedyn? zmienn? zwi?zan? z prezentowanym projektem b?dzie rodzaj kardioplegii stosowanej do ochrony mi??nia sercowego.Metod? zabiegowego leczenia zastawki aortalnej jest najcz??ciej jej wymiana (aortic valve repleacement- AVR). Operacja polega na usuni?ciu zniszczonej zastawki aortalnej i zast?pienie jej protez? mechaniczn? lub biologiczn?. Wybór rodzaju protezy jest kwesti? bardzo indywidualn? i zostanie z Pani?/Panem omówiona przy konsultacji lekarskiej.W rzadkich przypadkach istnieje mo?liwo?? naprawy w?asnej zastawki aortalnej- kwestia ewentualnej mo?liwo?ci naprawy zostanie z Pani?/Panem omówiona przy kwalifikacji i konsultacji lekarskiej.Zabieg odbywa si? na sali operacyjnej, w znieczuleniu ogólnym. Najcz??ciej stosowanym dost?pem jest sternotomia po?rodkowa (przeci?cie mostka w linii po?rodkowej cia?a). W trakcie procedury pacjent jest pod??czany do kr??enia pozaustrojowego, które ma za zadanie zast?pienie funkcji serca i rozprowadzenie krwi po organizmie.. Po operacji zostanie Pani/Pan przeniesiona/y na Oddzia? Pooperacyjny, gdzie wszystkie funkcje i parametry ?yciowe s? ?ci?le monitorowane. W przeci?gu nast?pnej doby trafi Pani/Pan z powrotem na Oddzia? Kardiochirurgii (pocz?tkowo sala intensywnego nadzoru, nast?pnie sale dzienne), gdzie b?dzie nast?powa?o stopniowe uruchomienie i pocz?tek rehabilitacji. W trakcie hospitalizacji do Pani/Pana dyspozycji pozostanie wykwalifikowany zespó? lekarski i piel?gniarski oraz rehabilitacyjny. W razie konieczno?ci istnieje mo?liwo?? skorzystania z porady psychologa, a tak?e w razie potrzeby wykonania dodatkowej konsultacji w ramach innych lekarskich dziedzin specjalistycznych.Po zakończeniu pobytu wewn?trzszpitalnego (zazwyczaj oko?o tygodnia) istnieje mo?liwo?? nieodp?atnego skorzystania z pobytu w O?rodku Rehabilitacji Kardiologicznej w Ustroniu (turnusy dwutygodniowe lub trzytygodniowe). Wszelkie zalecenia dotycz?ce post?powania, trybu ?ycia i leczenia po zabiegu operacyjnym zostan? z Pani?/Panem omówione przed opuszczeniem Oddzia?u Kardiochirurgii i odnotowane w karcie wypisowej.POTENCJALNE RYZYKORyzyko oko?ooperacyjne zosta?o dla Pani/Pana oszacowane wed?ug specjalnych skal ryzyka (Euroscore, Logistic Euroscore, Euroscore II) przy kwalifikacji do zabiegu operacyjnego. Nie wykazuje ono zale?no?ci od rodzaju podanej kardiopleginy, która jest przedmiotem niniejszego badania. Ryzyko oko?ozabiegowe jest w g?ównej mierze zale?ne od chorób towarzysz?cych i stopnia uszkodzenia mi??nia sercowego, a tak?e od kompleksowo?ci zabiegu.Ryzyko zwi?zane z znieczuleniem zostanie z Pani?/Panem omówione przy konsultacji anestezjologicznej. Mo?liwe, lecz rzadkie powik?ania zabiegu to: krwawienie, powik?ania zakrzepowo-zatorowe, infekcyjne zapalenie wsierdzia, gromadzenie si? p?ynu w osierdziu i op?ucnych, powik?ania infekcyjne, nieprawid?owe funkcjonowanie sztucznej zastawki, reoperacja, zaburzenia rytmu serca, zaburzenia funkcji innych narz?dów (np. nerki, w?troba, p?uca), zawa? serca, zgon.Literatura medyczna szacuje ryzyko ci??kich powik?ań oko?ooperacyjnych, w tym zgonu, na 3-4,8% w przypadku izolowanej wymiany zastawki aortalnej. Jak wcze?niej wspomniano, zostanie ono indywidualnie obliczone dla Pani/Pana przy u?yciu specjalistycznych skal oceny ryzyka.W przypadku koniecznej do wykonania u Pana/Pani procedury podawane roztwory kardiopleginy mog? wykazywa? pewne ró?nice co do oko?ooperacyjnej warto?ci markerów uszkodzenia mi??nia sercowego, cz?sto?ci pojawiania si? zmian w EKG, cz?sto?ci wykazywania obecno?ci nowych zaburzeń kurczliwo?ci mi??nia sercowego, cz?sto?ci konieczno?ci stosowania leków inotropowych w okresie oko?ooperacyjnym, cz?sto?ci wyst?powania zespo?u niskiego rzutu, cz?sto?ci konieczno?ci stosowania kontrapulsacji wewn?trzaortalnej, konieczno?ci stosowania stymulacji serca, cz?sto?ci wyst?powania zaburzeń rytmu w trakcie zatrzymywania serca podczas operacji, cz?sto?ci wyst?powania zaburzeń rytmu przy zakończeniu operacji, cz?sto?ci wyst?powania oko?ozabiegowych zaburzeń rytmu serca, cz?sto?ci wyst?powania oko?ooperacyjnych zawa?ów serca. Dotychczas przy zabiegach zastawki aortalnej u doros?ych nie wykazano jednoznacznie przewagi ?adnej z nich w tym zakresie.POTENCJALNE KORZY?CI Pacjent musi zdawa? sobie spraw?, ?e informacje uzyskane w wyniku tego badania mog? zosta? u?yte, aby pomóc innym. Zasadnicz? korzy?? stanowi sama w sobie korekcja chirurgiczna wady aortalnej, co eliminuje zagro?enie zdrowia i ?ycia zwi?zane z jej chorob?.POUFNO?? I OCHRONA DANYCH OSOBOWYCHPrzeprowadzenie niniejszego badania nie jest mo?liwe bez zgromadzenia i wykorzystania niektórych informacji z Pana/Pani dokumentacji medycznej, takich jak (lecz nie tylko) wiek, p?e? i dane kliniczne. Pana/Pani uczestnictwo w niniejszym badaniu pozostanie poufne. Poza dokumentacj? medyczn? b?dzie Pan/Pani identyfikowany(-a) wy??cznie poprzez przyznany Panu/Pani numer [numer identyfikacyjny, który nie ujawnia bezpo?rednio Pana/Pani to?samo?ci]. Przestrzegane b?d? zasady dotycz?ce ochrony danych, zgodnie z polsk? ustaw? o ochronie danych osobowych z 29/08/1997. Je?eli b?dzie Pan/Pani mie? jakie? pytania zwi?zane z ochron? danych osobowych, mo?na skontaktowa? si? z Generalnym Inspektorem Ochrony Danych Osobowych, ul. Stawki 2,00-193 Warszawa, .pl.Wykorzystywanie, przechowywanie, przesy?anie i niszczenie Państwa danych b?dzie zgodne z europejsk? dyrektyw? dotycz?c? ochrony danych osobowych 95/46 EC i zwi?zanymi z ni? przepisami poszczególnych krajów.Komisja Bioetyczna, która akceptuje badania dla tego szpitala, zatwierdzi?a nasz udzia? w tym badaniu. Osoby wyznaczone i inne upowa?nione osoby mog? mie? wgl?d do historii choroby oraz wyników badań, aby sprawdzi?, czy przedstawione informacje s? kompletne i poprawne. B?dziemy te? informowa? lekarza prowadz?cego pacjenta lub jego prowadz?cego kardiologa o uczestnictwie w tym badaniu. Podpisanie formularza zgody na badanie obejmuje te? zgod? na udost?pnienie swoich danych osobowych wy?ej wymienionym osobom. Zapewniamy, ?e poufno?? historii choroby zostanie zachowana przez ca?y czas. W momencie, gdy opublikowane zostan? wyniki badań, to?samo?? pacjenta pozostanie ca?kowicie utajniona.NOWE INFORMACJEW przypadku, gdy dost?pne b?d? jakiekolwiek informacje, jakie mog?yby mie? wp?yw na uczestnictwo pacjenta w badaniu, zobowi?zujemy si? jak najszybciej powiadomi? o tym pacjenta.UCZESTNICTWO I REZYGNACJA Z BADA?Udzia? w badaniu jest dobrowolny. Odmowa udzia?u nie wp?ynie w ?aden sposób na dalsze leczenie oraz korzy?ci wynikaj?ce z pobytu w tym szpitalu. Po wyra?eniu zgody na udzia? w badaniu mo?na w dowolnym momencie przerwa? udzia?, bez wp?ywu na dalsz? opiek? medyczn?. Udzia? w badaniu nie b?dzie mie? w ?aden sposób wp?ywu na koszty leczenia pacjenta. Pacjent b?dzie mie? prawo do wycofania si? z próby w dowolnym momencie, bez konieczno?ci podawania powodu. Nie b?dzie to mie? wp?ywu na relacj? z kardiologiem pacjenta lub z personelem piel?gniarskim w jakimkolwiek czasie. Nie wp?ynie to tak?e na jego normalne leczenie i opiek? nad pacjentem. Wycofanie si? z próby nie usuwa automatycznie zezwolenia, którego udzieli?(-a) Pan/Pani lekarzowi przeprowadzaj?cemu prób? na wykorzystywanie i ujawnianie Pana/Pani danych personalnych. Aby temu zapobiec, lekarz przeprowadzaj?cy prób? musi otrzyma? pismo, w którym o?wiadcza Pan/Pani, ?e nie zgadza si? na dalsze wykorzystywanie swoich informacji osobistych. Pana/Pani o?wiadczenie nie b?dzie dotyczy?o informacji przekazanych uprzednio ani zebranych przed otrzymaniem Pana/Pani o?wiadczenia.Lekarz pacjenta mo?e tak?e wycofa? go z badania bez pozwolenia samego pacjenta, je?li uzna, ?e jest to w najlepszym interesie pacjenta.CZYNNIKI DYSKWALIFIKUJ?CEProcedura badania nie zostanie przeprowadzona, je?li pacjent/ka nie wyra?a zgody na badanie, ma inne towarzysz?ce wady zastawkowe wymagaj?ce chirurgicznej korekcji, ?ródzabiegowo zostanie stwierdzona ?porcelanowa aorta”, zabieg b?dzie reoperacj?, chory/a ma mniej ni? 18 lat, w wywiadzie istnieje uczulenie na lignokain?, pacjent/ka choruje na chorob? niedokrwienn? serca wymagaj?c? interwencji chirurgicznej, pacjentka jest w ci??y.REKOMPENSATA ZA UDZIA? W BADANIUUczestnictwo w niniejszym projekcie jest zupe?nie dobrowolne; nie otrzyma Pan/Pani za nie ?adnego wynagrodzenia. Nie b?dzie Pana/Pani p?aci?(a) za ?adne z procedur ani testy przeprowadzone podczas badania, w czasie Pana/Pani udzia?u w badaniu klinicznym. PROBLEMY LUB PYTANIAJe?li pacjent pragnie uzyska? wi?cej informacji na temat tego badania lub ryzyk, korzy?ci lub alternatyw medycznych, nale?y skontaktowa? si? ze swoim lekarzem. Nale?y te? poinformowa? lekarza o przebytej chorobie lub hospitalizacji z dowolnego powodu w czasie badania.Je?li pojawi? si? jakiekolwiek problemy lub pytania w zwi?zku z badaniem, dotycz?ce praw pacjenta jako uczestnika w badaniu lub w zwi?zku z jak?kolwiek poniesion? szkod? wynikaj?c? z badania, nale?y skontaktowa? si? z lekarzem.Imi? i nazwisko……………………………………………………………….Numer telefonu………………………………………………………………Osoby, które zosta?y zakwalifikowane do programu lub ju? s? jego uczestnikami posiadaj? uprawnienia, które wynikaj? z Praw Pacjenta zamieszczonych w Karcie Praw Pacjenta. Informacji na ten temat mo?e udzieli? powo?ane przez Ministra Zdrowia Biuro Rzecznika Praw Pacjenta, Aleja zjednoczenia 25, 01-829 Warszawa, pod numerem infolinii 0800 190?590.DOKUMENT ZGODYNale?y zachowa? kopi? tego dokumentu dla w?asnej dokumentacji.FORMULARZ ?WIADOMEJ ZGODYTakNiePotwierdzam, ?e zapozna?em si? i zrozumia?em informacje dotycz?ce badania ?Ocena 30-dniowa klinicznych efektów zastosowania kardioplegii del Nido w chirurgii zastawki aortalnej” i mia?am/em mo?liwo?? zadawania pytań. FORMCHECKBOX FORMCHECKBOX Wiem, ?e Komisja Bioetyczna zapozna?a si? z tym badaniem i wyrazi?a pozytywn? opini?. FORMCHECKBOX FORMCHECKBOX Rozumiem, ?e wszystkie dokumenty znajduj?ce si? w karcie lekarskiej pozostan? obj?te ?cis?? tajemnic? lekarsk?. Wiem te?, ?e z notatkami medycznymi dotycz?cymi mnie mog? zapozna? si?: osoba odpowiedzialna z American Heart of Poland S.A.. lub reprezentant organy/w?adze ochrony zdrowia.Wyra?am zgod?, aby takie osoby mia?y dost?p do moich danych. FORMCHECKBOX FORMCHECKBOX Zdaj? sobie spraw?, ?e moje uczestnictwo jest dobrowolne i ?e mog? wycofa? si? w dowolnym terminie, bez podawania powodu, bez uszczerbku dla przys?uguj?cej mi opieki medycznej lub praw. W dowolnej chwili mog? ??da? dodatkowych wyja?nień. FORMCHECKBOX FORMCHECKBOX Ja, ni?ej podpisany wyra?am dobrowolnie zgod? na uczestnictwo w badaniu: Ocena 30-dniowa klinicznych efektów zastosowania kardioplegii del Nido w chirurgii zastawki aortalnej zgodnie z opisem w Informacjach dla Uczestnika Badania.Otrzyma?am/em kopi? informacji dla pacjenta oraz formularza zgody, podpisan? przez lekarza.Pacjent:Podpis:Data: Lekarz:O?wiadczam niniejszym, i? poinformowa?em pacjenta o celu, potencjalnym ryzyku oraz konsekwencjach powy?szego badania.Imi? i nazwisko:______ Podpis: __ Data:Appendix IVWMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTSPreamble1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.General Principles3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.5. Medical progress is based on research that ultimately must include studies involving human subjects.6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.11. Medical research should be conducted in a manner that minimises possible harm to the environment.12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.Risks, Burdens and Benefits16. In medical practice and in medical research, most interventions involve risks and burdens.Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.Vulnerable Groups and Individuals19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.All vulnerable groups and individuals should receive specifically considered protection.20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.Scientific Requirements and Research Protocols21. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.22. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.Research Ethics Committees23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.Privacy and Confidentiality24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal rmed Consent25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.All medical research subjects should be given the option of being informed about the general outcome and results of the study.27. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.Use of Placebo33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; orWhere for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an interventionand the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.Extreme care must be taken to avoid abuse of this option.Post-Trial Provisions34. In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.Research Registration and Publication and Dissemination of Results35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.Unproven Interventions in Clinical Practice37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.References1.Rebeyka IM, Axford-Gatley RA, Bush BG, del Nido PJ, Mickle DA, Romaschin AD, Wilson GJ. Calcium paradox in an in vivo model of multidose cardioplegia and moderate hypothermia. Prevention with diltiazem or trace calcium levels. J Thorac Cardiovasc Surg. 1990 Mar;99(3):475-83.2.Brown PS Jr, Holland FW, Parenteau GL, Clark RE. Magnesium ion is beneficial in hypothermic crystalloid cardioplegia Ann Thorac Surg. 1991 Mar;51(3):359-663.Dobson GP1, Jones MW. Adenosine and lidocaine: a new concept in nondepolarizing surgical myocardial arrest, protection, and preservation. J Thorac Cardiovasc Surg. 2004 Mar;127(3):794-805.4.Suaudeau J, Shaffer B, Daggett WM, Austen WG, Erdmann AJ 3rd. Role of procaine and washed red cells in the isolated dog heart perfused at 5 degrees C. J Thorac Cardiovasc Surg. 1982 Dec;84(6):886-96.indapillai A, Hua R, Rose R, Friesen CH, O'Blenes SB. Protecting the aged heart during cardiac surgery: use of del Nido cardioplegia provides superior functional recovery in isolated hearts. J Thorac Cardiovasc Surg. 2013 Oct;146(4):940-8. doi: 10.1016/j.jtcvs.2013.05.032. Epub 2013 Aug 156.Kuna Kim, BS Clifford Ball, BS Patrick Grady, BS and Stephanie Mick, MD Use of del Nido Cardioplegia for Adult Cardiac Surgery at the Cleveland Clinic: Perfusion Implications J Extra Corpor Technol. 2014 Dec; 46(4): 317–323.7.Gregory S. Matte, BS, CCP, LP, FPP and Pedro J. del Nido, MD History and Use of del Nido Cardioplegia Solution at Boston Children’s Hospital, J Extra Corpor Technol. 2012 Sep; 44(3): 98–1038. Pehkonen EJ, Anttonen OM, Tarkka MR. Blood and crystalloid cardioplegia in aortic valve surgery Ann Chir Gynaecol. 1994;83(4):292-5.9. Wallace SR, Baker AB. Incidence of ventricular fibrillation after aortic cross- clamp elease using lignocaine cardioplegia. Anaesth Intensive Care 1994; 22: 442-6.10. Hottenrott C, Maloney JV, Buckberg G. Studies of effects of ventricular fibrillation on the adequacy of regional myocardial flow. Part III. Mechanisms of ischemia. J Thorac Cardiovasc Surg 1974; 68: 634-45.11. Buckberg GD, Hottenrott CE. Ventricular fibrillation: its effect on myocardial flow, distribution and performance. Ann Thorac Surg 1975; 20: 76-85.12.Khuri SF, Marston WA, Josa M, Braunwald NS, Cavanaugh AC, Hunt H, Barsamian EM. Observations on 100 patients with continuous intraoperative monitoring of intramyocardial pH: the adverse effects of ventricular fibrillation and reperfusion. J Thorac Cardiovasc Surg 1985; 89: 170-82.13. Lockermen ZS, Rose DM, Cunningham JN, Lichstein E . Repefusion ventricular fibrillation during coronary artery bypass operations and ist association with postoperative enzyme release. J Thorac Cardiovasc Surg 1987; 93: 247-52.14.Baraka A, Hirt N, Dabbous A, Taha S, Rouhana C, el-Khoury N, Ghabash M, Jamhoury M, Sibaii A. Lidocaine cardioplegia for prevention of reperfusion ventricular fibrillation. Ann Thorac Surg 1993; 55: 1529-33.15.Dahl CF, Ewy GA, Warner ED, Thomas ED. Myocardial necrosis from direct current countershock. Circulation 1974; 50: 956-61.16. Kar SK, Dasgupta CS, Goswami A. Effect of prophylactic amiodarone in patients with rheumatic valve disease undergoing valve replacement surgery. Ann Card Anaesth. 2011 Sep-Dec;14(3):176-82. doi: 10.4103/0971-9784.83986.17.G Limongelli, V Ducceschi, A D’Andrea, A Renzulli, B Sarubbi, M De Feo, F Cerasuolo, R Calabrò, and M Cotrufo Risk factors for pacemaker implantation following aortic valve replacement: a single centre experience Heart. 2003 Aug; 89(8): 901–904.18.Mick SL, Robich MP, Houghtaling PL, Gillinov AM, Soltesz EG, Johnston DR, Blackstone EH4, Sabik JF 3rd. del Nido versus Buckberg cardioplegia in adult isolated valve surgery. J Thorac Cardiovasc Surg. 2015 Feb;149(2):626-634; discussion 634-6. doi: 10.1016/j.jtcvs.2014.10.085. Epub 2014 Oct 22.19.Ota T, Yerebakan H, Neely RC, Mongero L, George I, Takayama H, Williams MR, Naka Y, Argenziano M, Bacha E, Smith CR, Stewart AS. Short-term outcomes in adult cardiac surgery in the use of del Nido cardioplegia solution. Perfusion. 2016 Jan;31(1):27-33. doi: 10.1177/0267659115599453. Epub 2015 Jul 30.20.Robert A. Sorabella, MD, Hiro Akashi, MD, Halit Yerebakan, MD, Marc Najjar, MD, Ayesha Mannan, BS, Mathew R. Williams, MD, Craig R. Smith, MD, and Isaac George, MD Myocardial Protection Using del Nido Cardioplegia Solution in Adult Reoperative Aortic Valve Surgery J Card Surg. 2014 Jul; 29(4): 445–449.21.Günday M, Bing?l H Is crystalloid cardioplegia a strong predictor of intra-operative hemodilution? J Cardiothorac Surg. 2014 Jan 27;9:23. doi: 10.1186/1749-8090-9-23.22.Expert Consensus Document Third universal definition of myocardial infarction European Heart Journal (2012) 33, 2551–256723.KDIGO Clinical Practice Guideline for Acute Kidney Injury, VOL 2 | SUPPLEMENT 1 | MARCH 2012 ................
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