Analytic comments of the initial results of the VISION (Vascular events In noncardiac Surgery patIents cOhort evaluatioN): Association between troponin T and mortality at 30 days in noncardiac surgery patients

Garutti, I.; Paniagua, P.; Cruz, P.; Maestre, M.L.; Fernández-Riveira, C.; Alonso-Coello, P.
doi:10.1016/j.redar.2012.10.015
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The initial results of the VISION study &#40;<span class="elsevierStyleUnderline">V</span>ascular events <span class="elsevierStyleUnderline">I</span>n noncardiac <span class="elsevierStyleUnderline">S</span>urgery pat<span class="elsevierStyleUnderline">I</span>ents c<span class="elsevierStyleUnderline">O</span>hort evaluatio<span class="elsevierStyleUnderline">N</span>&#41; have recently been published in JAMA&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> VISION was proposed&#44; designed&#44; and directed by the team of Dr&#46; Devereaux &#40;McMaster University&#44; Ontario&#44; Canada&#41;&#44; a cardiologist&#8211;epidemiologist who runs a perioperative ischemia research program&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;3</span></a> VISION is a prospective international multicenter cohort study&#44; with more than 20&#44;000 patients recruited to date&#46; The two participating centers in Spain&#44; with over 3700 patients included&#44; are&#44; respectively&#44; Hospital Sant Pau in Barcelona&#44; and Hospital Gregorio Mara&#241;&#243;n&#44; in Madrid&#46; The study initially intended to recruit 40&#44;000 patients&#59; however&#44; due to a change in the type of troponin T &#40;TnT&#41; assay being used in many hospitals &#8211; the fourth-generation TnT assay has been progressively replaced by the ultrasensitive fifth-generation TnT assay &#8211; only fourth-generation troponin T results have been analyzed&#46; VISION is currently ongoing in hospitals of the other countries&#44; although monitoring is now being conducted with the fifth-generation TnT assay&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The VISION design is relatively simple and pragmatic&#46; TnT is monitored in all consecutive patients with 45 years of age or more who undergo noncardiac surgery &#40;scheduled or urgent&#47;emergent&#41; and stay in hospital for at least one night after surgery&#46; In patients who give their consent&#44; TnT is measured four times at 6&#8211;12<span class="elsevierStyleHsp" style=""></span>h on days 1&#44; 2&#44; and 3 after surgery&#46; Patients with TnT<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#46;04<span class="elsevierStyleHsp" style=""></span>ng&#47;mL &#40;that is considered the threshold value&#41; in any of the samples are managed as shown in <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">The main objectives of this study were&#58; &#40;1&#41; analyzing the association between postoperative TnT values and postoperative mortality&#59; &#40;2&#41; analyzing the incidence of major vascular events after surgery &#40;death from vascular cause&#44; nonfatal acute myocardial infarction &#8211; AMI-&#44; cardiac arrest&#44; and syncope&#41;&#59; &#40;3&#41; developing an optimal clinical model for predicting major vascular complications after surgery&#59; and &#40;4&#41; assessing the proportion of patients who experience an AMI at 30 days after surgery which would not have been detected without the monitoring with TnT&#46; Results corresponding to the first objective have now been published with the peak TnT value during the first 3 days after surgery being significantly associated with mortality at 30 days&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">This first analysis included 15&#44;133 patients and adopted a risk model in which the dependent variable was death at 30 days&#44; the incidence being 1&#46;9&#37; &#40;282&#47;15&#44;133&#41;&#46; The model included 24 preoperative variables&#44; of which only 11 were independent risk factors for death at 30 days &#40;age&#44; recent high-risk coronary disease&#44; peripheral vascular disease&#44; stroke&#44; chronic obstructive pulmonary disease&#44; active cancer&#44; urgent or emergency surgery&#44; major general surgery&#44; major neurosurgery&#44; heart failure history&#44; and major vascular surgery&#41;&#46; The variable with the greatest risk was emergency surgery &#40;rate ratio or adjusted hazard ratio 4&#46;62 &#91;95&#37; CI&#44; 3&#46;57&#8211;5&#46;98&#93;&#41;&#46; A second risk model was conducted&#44; using the same variables as the first one&#44; but this time including the variable &#8220;peak TnT during the first 72<span class="elsevierStyleHsp" style=""></span>h&#8221;&#46; Results showed that this was associated with the greatest risk of death at 30 days&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Patients with a peak TnT value of 0&#46;01 or less&#44; 0&#46;02&#44; 0&#46;03&#8211;0&#46;29&#44; and 0&#46;30<span class="elsevierStyleHsp" style=""></span>ng&#47;mL or greater had 30-day mortality rates of 1&#46;0&#37;&#44; 4&#46;0&#37;&#44; 9&#46;3&#37;&#44; and 16&#46;9&#37;&#44; respectively&#46; Peak TnT measurement added incremental prognostic value to discriminate those likely to die within 30 days for the model with peak TnT measurement vs those without&#46; The population-attributable risk suggests that patients showing increased TnT levels suffered 41&#46;8&#37; of deaths during the first 30 days after surgery&#46; During the first 3 days after noncardiac surgery&#44; 1 in 25 patients with a fourth-generation TnT value of 0&#46;02<span class="elsevierStyleHsp" style=""></span>ng&#47;mL would die within a month&#44; as would 1 in 11 with TnT ranging from 0&#46;03<span class="elsevierStyleHsp" style=""></span>ng&#47;mL to 0&#46;29 and 1 in 6 with TnT greater than 0&#46;3<span class="elsevierStyleHsp" style=""></span>ng&#47;mL&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Perioperative cardiovascular complications are an important concern among clinicians responsible for patients&#8217; perioperative care&#46; The only prospective study to date aimed at determining cardiovascular risk in surgery in nonselected patients is that conducted by Lee et al&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Based on their findings&#44; the authors developed the Lee risk index&#44; which is widely used in clinical practice&#46; However&#44; this study was based on 4315 patients recruited from 1989 to 1994&#44; excluded patients undergoing emergency surgery&#44; did not consider syncope as a vascular complication&#44; and used CPK-MB as a biomarker of myocardial damage&#46; These limitations make it&#44; therefore&#44; necessary to establish new risk indexes representative of current perioperative care&#46; The VISION study will deal with this issue in the near future with the development of a risk prediction model that addresses the limitations of the previous ones&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Perioperative myocardial infarctions &#40;PMIs&#41; differ considerably from those observed in nonsurgical patients&#44; and they often go undetected unless cardiac enzymes or troponins are monitored after surgery&#46; A joint analysis of studies investigating this finding showed that only 16&#37; of patients with PMI have the characteristic chest pain&#47;tightness&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#8211;7</span></a> The reasons for this are&#58; &#40;1&#41; most cases of AMI occur during the first 3 days after surgery&#44; when patients usually receive analgesics&#59; &#40;2&#41; a small number of patients &#40;generally with high cardiac risk&#41; remain intubated or sedated during this period of greatest risk&#59; &#40;3&#41; postoperative signs &#40;hypotension&#44; tachycardia&#41; and symptoms &#40;dyspnea&#44; nausea&#41; generally experienced by patients after the surgical procedure that in other circumstances would alert us of a MI are usually attributed to other postoperative complications &#40;e&#46;g&#46; pneumonia&#44; atelectasis&#44; hypovolemia&#44; bleeding&#44; incisional pain or medication side effects&#41;&#46; Thus in this context&#44; specific biomarkers such as TnT become very relevant&#46; To date most studies have evaluated the performance of CPK-MB for the diagnosis of perioperative MI&#46; However&#44; compared with TnT&#44; CPK&#44; being a striated muscle enzyme&#44; yields a high proportion of false positives&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> Furthermore&#44; during the first few days after surgery&#44; CPK levels are high as a result of postsurgical trauma&#59; therefore&#44; the CPK-MB&#47;CPK ratio is usually low&#44; leading to false negatives too&#46; The prognostic value of TnT has been analyzed in a meta-analysis of 14 studies &#40;3318 patients and 459 deaths&#41; by Devereaux&#39;s research group showing the usefulness of monitoring TnT for predicting postoperative mortality during the first year &#40;data on CPK-MB were limited&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">However&#44; no studies to date have investigated the performance of TnT monitoring in a large of nonselected cohort of surgical patients such as those included in the VISION study&#46; Even though TnT is not routinely measured after noncardiac surgery&#44; the simplicity of the test and its performance suggest that it could prove being considerably useful in the immediate postoperative period&#46; However&#44; the type of patient and&#47;or surgery in which the cost-effectiveness ratio would advise routine monitoring of TnT has yet to be determined&#46; The cost-effectiveness of TnT monitoring will be addressed in the near future in the VISION study&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">A key finding from this first VISION analysis is that TnT numbers that are considered irrelevant in clinical practice have shown a poorer prognostic value than what was previously thought&#46; In <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a> we can see that cardiologist was only called when TnT was &#62;0&#46;04<span class="elsevierStyleHsp" style=""></span>ng&#47;mL&#46; However patients with TnT between 0&#46;02 and 0&#46;04<span class="elsevierStyleHsp" style=""></span>ng&#47;mL had a fourfold higher risk of death than patients with values lower than 0&#46;01<span class="elsevierStyleHsp" style=""></span>ng&#47;mL &#40;4&#37; vs 1&#37;&#41;&#46; The findings of VISION must therefore change clinical practice&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Another striking aspect of the initial results of VISION is the association between peak TnT values and mortality due to nonvascular complications&#46; Nonvascular mortality was almost twice that of vascular mortality among patients with a peak TnT value between 0&#46;02 and 0&#46;029<span class="elsevierStyleHsp" style=""></span>ng&#47;mL &#40;1&#46;41&#37; vs 2&#46;63&#37;&#41;&#59; nevertheless&#44; in patients with higher TnT values this difference was not observed&#46; This finding could be based on the assumption that patients with myocardial damage might be expected to have a higher risk of a noncardiologic complication and&#47;or that silent myocardial insult could mean that any nonvascular complication would imply a poorer prognosis &#40;e&#46;g&#46; a patient with pneumonia would be less able to overcome the increased myocardial demand for oxygen&#41;&#46; In other words&#44; by reducing the degree of postoperative silent myocardial damage&#44; we would be improving both the prognosis of vascular complications&#44; and of nonvascular complications&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">As with nonsurgical patients&#44; early diagnosis of postoperative myocardial ischemia makes it possible to apply more effective measures for preventing death &#40;monitoring in critical care units&#44; coronary procedures&#44; and more rigorous correction of hypovolemia&#44; hypoxia&#44; and anemia&#41;&#46; In addition&#44; many patients with high postoperative TnT levels do not receive prophylaxis &#40;aspirin&#44; betablocking drugs&#44; statins&#44; angiotensin-converting enzyme inhibitors&#41;&#44; and treatment could be administered as soon as this peak is detected&#46; However&#44; the optimal approach to managing postoperative myocardial damage is still to be determined in order to improve prognosis&#46; Moreover&#44; adequately powered clinical trials are necessary&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> Finally&#44; it seems clear that a standard diagnostic strategy is insufficient to detect PMIs and that biochemical tests are needed in the noncardiac surgical population&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">As the results of VISION are being analyzed&#44; the available data on other aspects of perioperative cardiac-related risk will represent an important advance for all those working in perioperative medicine&#46;</p></span>"
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            "apendice" => "<p id="par0075" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Hospital Sant Pau &#40;Barcelona&#41;</span>&#58; Pilar Paniagua&#44; Mari Luz Maestre&#44; Pablo Alonso-Coello&#44; Marta De Antonio&#44; Ra&#250;l Gonzalez&#44; Adri&#224; Font&#44; Cecilia Mart&#237;nez&#44; Sonia Mirabet&#44; Xavier Pelaez&#44; Miquel Santal&#243;&#44; Jose Marcial Villamor&#46;</p> <p id="par0080" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Hospital Gregorio Mara&#241;&#243;n Madrid</span>&#58; Ignacio Garutti&#44; Patricia Cruz&#44; Carmen Fern&#225;ndez-Riveira&#44; Maria Palencia&#44; Patricia Pi&#241;eiro&#44; Alberto Varela&#44; Susana D&#237;az&#44; Teresa del Castillo&#44; Angeles de Miguel&#44; Manuel Mu&#241;oz&#44; Maria del Barrio&#44; Gabriel Cusati&#44; Alejandro Fern&#225;ndez&#44; M&#46; Jos&#233; Membrillo&#44; Erika San Juan&#44; Maite Torre&#44; Mercedes Garc&#237;a&#44; Carolina Puertas&#44; Hector Bueno&#44; Pedro Luis S&#225;nchez&#46;</p>"
            "etiqueta" => "Appendix A"
            "titulo" => "Spanish VISION investigators"
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        "titulo" => "Acknowledgements"
        "texto" => "<p id="par0065" class="elsevierStylePara elsevierViewall">Dr&#46; Alonso-Coello and Dr&#46; Garutti have received a grant from the <span class="elsevierStyleGrantSponsor"><span class="elsevierStyleItalic">Fundaci&#243; la Marat&#243;</span></span>&#46;</p> <p id="par0070" class="elsevierStylePara elsevierViewall">Dra&#46; Cruz received a grant from the <span class="elsevierStyleGrantSponsor"><span class="elsevierStyleItalic">Instituto de Salud Carlos III</span></span> &#40;Beca FIS 2008-11&#41;&#46;</p>"
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