Acute coronary syndrome and khat herbal amphetamine use: an observational report.

BACKGROUND: The khat plant is a stimulant similar to amphetamine and is thought to induce coronary artery spasm. Khat is widely chewed by individuals originating from the Horn of Africa and the Arabian Peninsula. The aim of this study was to evaluate the clinical characteristics and outcome of khat chewers presenting with acute coronary syndrome. METHODS AND RESULTS: From October 1, 2008, through June, 30, 2009, 7399 consecutive patients with acute coronary syndrome were enrolled in the Second Gulf Registry of Acute Coronary Events (Gulf RACE-2). Nineteen percent of patients were khat chewers; 81% were not. Khat chewers were older, more often male, and less likely to have cardiovascular risk factors. Khat chewers were less likely to have a history of coronary artery disease and more likely to present late and to have higher heart rate and advanced Killip class on admission. Khat chewers were more likely to present with ST-segment-elevation myocardial infarction. Overall, khat chewers had higher risk of death, recurrent myocardial ischemia, cardiogenic shock, ventricular arrhythmia, and stroke compared with non-khat chewers. After adjustment for baseline variability, khat chewing was found to be an independent risk factor of death and for recurrent ischemia, heart failure, and stroke. CONCLUSIONS: Our data confirm earlier observations of worse in-hospital outcome among acute coronary syndrome patients who chew khat. This worse outcome persists up to 1 year from the index event. This observational report underscores the importance of improving education concerning the cardiovascular risks of khat chewing.

Impact of anemia on in-hospital, one-month and one-year mortality in patients with acute coronary syndrome from the Middle East.

AIM: The aim of this study was to evaluate the impact of admission anemia on in-hospital, one-month, and one-year mortality in patients from the Middle East with acute coronary syndrome (ACS). METHODS: Data were analyzed from 7922 consecutive patients admitted to hospitals throughout six Middle-Eastern countries with the final diagnosis of ACS, as part of Gulf RACE II (Registry of Acute Coronary Events II). Anemia at admission was defined according to the World Health Organization definition (<13 g/dL in men and <12 g/dL in women). Analyses were conducted using univariate and multivariate statistical techniques. RESULTS: The median age of the cohort was 56 (48-65) years, with the majority being male (79%). Anemia at admission was present in 2241 patients (28%). Patients with anemia were more likely to have in-hospital complications including heart failure, recurrent ischemia, re-infarction, cardiogenic shock, stroke, and major bleed. Even after adjustment, anemia was still associated with mortality at in-hospital (odds ratio [OR]=1.71, 95% confidence interval [CI], 1.34-2.17; P<0.001), at one-month (OR=1.34, 95% CI, 1.06-1.71; P=0.016), and at one-year (OR=1.22, 95% CI, 1.01-1.49; P=0.049) post-admission with ACS. CONCLUSIONS: Admission anemia in patients with ACS from six Middle-Eastern countries was strongly associated with mortality at in-hospital, one-month, and at one-year. Hence, admission anemia must be considered in the initial risk assessment of ACS patients along with other risk scores.

Relation of Frailty to Outcomes in Patients With Acute Coronary Syndromes.

This study examines a national cohort of patients with a diagnosis of acute coronary syndrome (ACS) for the prevalence of frailty, temporal changes over time, and its association with treatments and clinical outcomes. The National Inpatient Sample database was used to identify US adults with a diagnosis of ACS between 2004 and 2014. Frailty risk was determined using a validated Hospital Frailty Risk Score based on ICD-9 codes using the cutoffs <5, 5 to 15, and >15 for low- (LRS), intermediate- (IRS), and high-risk (HRS) frailty scores, respectively. Logistic regression assessed associations of frailty with clinical outcomes, adjusted for patient co-morbidities and hospital characteristics. From 7,398,572 hospital admissions with ACS between 2004 and 2014, 86.5% of patients had LRS, 13.4% had an IRS, and 0.1% had an HRS. From 2004 to 2014, the prevalence of IRS and HRS patients increased from 8.1% to 18.2% and 0.03% to 0.18%, respectively (p <0.001 for both). The proportion of patients treated with percutaneous coronary intervention was greatest among patients with lowest frailty risk scores (LRS 42.9%, IRS 21.0%, and HRS 14.6%). Comparing HRS to LRS, there was a significant increase in bleeding complications (odds ratio [OR] 2.34, 95% confidence interval [CI] 2.03 to 2.69), vascular complications (OR 2.08, 95% CI 1.79 to 2.41), in-hospital stroke (OR 7.84, 95% CI 6.93 to 8.86), and in-hospital death (OR 2.57, 95% CI 2.18 to 3.04). Risk of frailty is common among patients with ACS, is increasing in prevalence, and is associated with differential management strategies, and outcomes during hospitalization. Increased awareness could facilitate frailty-tailored care to minimize the risk of adverse outcomes.

Impact of Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptors Blockers on Mortality in Acute Heart Failure Patients with Left Ventricular Systolic Dysfunction in the Middle East: Observations from the Gulf Acute Heart Failure Registry (Gulf CARE).

AIMS: To evaluate the impact of Angiotensin-Converting Enzyme Inhibitors (ACEIs)/ Angiotensin Receptors Blockers (ARBs) on in-hospital, 3- and 12-month all-cause mortality in Acute Heart Failure (AHF) patients with left ventricular systolic dysfunction in 7 countries of the Middle East. METHODS AND RESULTS: Data was analysed from 2,683 consecutive patients admitted with AHF and Left Ventricular Ejection Fraction (LVEF) (<40%) from 47 hospitals from February to November 2012. Analyses were evaluated using univariate and multivariate statistics. The overall mean age of the cohort was 58±15, 72% (n=1,937) were males, 62% (n=1,651) had coronary artery disease, 57% (n=1,539) were hypertensives and 47% (n=1,268) had diabetes. Overall cumulative mortality at inhospital, 3- and 12-month follow-up was 5.8% (n=155), 12.6% (n=338) and 20.4% (n=548), respectively. Adjusting for demographic and clinical characteristics as well as medication in a multivariate logistic regression model, ACEIs were associated with lower risk of in-hospital mortality (adjusted odds ratio (aOR), 0.48; 95% Confidence Interval (CI): 0.25 to 0.94; p=0.031). At 3-month follow-up, both ACEIs (aOR, 0.64; 95% CI: 0.43 to 0.95; p=0.025) and ARBs (aOR, 0.34; 95% CI: 0.18 to 0.62; p<0.001) were associated with lower risk of mortality. Additionally, at 12-month follow-up, those prescribed ACEIs (aOR, 0.71; 95% CI: 0.53 to 0.96; p=0.027) and ARBs (aOR, 0.47; 95% CI: 0.31 to 0.71; p<0.001) were still associated with lower risk of mortality. CONCLUSION: ACEIs and ARBs treatments were associated with lower mortality risk during admission and up to 12-month of follow-up in Middle East AHF patients with left ventricular systolic dysfunction.

Systolic Blood Pressure on Admission and Mortality in Patients Hospitalized With Acute Heart Failure: Observations From the Gulf Acute Heart Failure Registry.

We investigated the role of systolic blood pressure (SBP) in relation to in-hospital and postdischarge mortality in patients admitted with acute heart failure (AHF). The SBP of 4848 patients aged ≥18 years admitted with AHF was categorized into 5 groups: ≤90, 91 to 119, 120 to 139, 140 to 161, and >161 mm Hg. After adjusting for several confounders, multivariate logistic regression models showed that admission SBP was a significant predictor of mortality among both patients with preserved left ventricular function (defined as left ventricular ejection fraction [LVEF] ≥40%) and patients with left ventricular dysfunction (LVEF <40%). The adjusted odds ratios of in-hospital, 3-month, and 1-year mortality in the lowest SBP groups were 7.06 (95% confidence interval [CI]: 3.28-15.20; P < .001), 2.59 (95% CI: 1.35-4.96; P = .004), and 3.10 (95% CI: 2.04-4.72; P < .001) times the odds in the highest admission group (SBP > 161 mm Hg), respectively. We conclude that low admission SBP is an independent predictor of mortality in patients with AHF. The higher the admission SBP, the better the prognosis, regardless of age or LVEF.

Unraveling the spectrum of left bundle branch block in acute myocardial infarction: insights from the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT 2 and 3) trials.

BACKGROUND: Left bundle branch block (LBBB) complicates the diagnosis of acute myocardial infarction (AMI). The Sgarbossa criteria were developed from GUSTO I to surmount this diagnostic challenge but have not been prospectively validated in a large population with presumed AMI. We evaluated their utility in the diagnosis and risk stratification of AMI patients in ASSENT 2 & 3. METHODS: Baseline electrocardiograms (ECG) of LBBB patients were scored using Sgarbossa's criteria (0-10) by 2 readers blinded to the CK/CK-MB data and clinical outcomes; 267 (1.2%) patients had LBBB on their baseline ECG. RESULTS: Among 253 LBBB patients with available peak CK/CK-MB data, 158 (62.5%) had peak CK/CK-MB levels > 2x ULN, thereby qualifying for the diagnosis of AMI. A Sgarbossa score of 3 was shown in 48.7% of LBBB patients with elevated CK/CK-MB versus in 12.6% of those without a CK/CK-MB rise (P < .001). Patients with higher Sgarbossa scores, ie, 3, had a higher mortality compared with those with a score < 3, (23.5% vs 7.7% at 30 days P < .001; and 33.7% vs 20.2% at 1 year, P < .001, respectively). CONCLUSIONS: Our findings validate the utility of Sgarbossa criteria for diagnosing AMI in the setting of LBBB. These criteria provide a simple and practical diagnostic approach to risk stratify this diagnostically challenging high-risk group and optimize risk-benefit of acute therapy.

Comparison of Indian subcontinent and Middle East acute heart failure patients: Results from the Gulf Acute Heart Failure Registry.

OBJECTIVE: To compare Middle East Arabs and Indian subcontinent acute heart failure (AHF) patients. METHODS: AHF patients admitted from February 14, 2012 to November 14, 2012 in 47 hospitals among 7 Middle East countries. RESULTS: The Middle Eastern Arab group (4157) was older (60 vs. 54 years), with high prevalence of coronary artery disease (48% vs. 37%), valvular heart disease (14% vs. 7%), atrial fibrillation (12% vs. 7%), and khat chewing (21% vs. 1%). Indian subcontinent patients (382) were more likely to be smokers (36% vs. 21%), alcohol consumers (11% vs. 2%), diabetic (56% vs. 49%) with high prevalence of AHF with reduced ejection fraction (76% vs. 65%), and with acute coronary syndrome (46% vs. 26%). In-hospital mortality was 6.5% with no difference, but 3-month and 12-month mortalities were significantly high among Middle East Arabs, (13.7% vs. 7.6%) and (22.8% vs. 17.1%), respectively. CONCLUSIONS: AHF patients from this region are a decade younger than Western patients with high prevalence of ischemic heart disease, diabetes mellitus, and AHF with reduced ejection fraction. There is an urgent need to control risk factors among both groups, as well as the need for setting up heart failure clinics for better postdischarge management.

Acute Coronary Syndrome in Indian Subcontinent Patients Residing in the Middle East: Results From Gulf Registry of Acute Coronary Events II.

We compared baseline characteristics, clinical presentation, and in-hospital outcomes between Middle Eastern Arabs and Indian subcontinent patients presenting with acute coronary syndrome (ACS). Of the 7930 patients enrolled in Gulf Registry of Acute Coronary Events II (RACE II), 23% (n = 1669) were from the Indian subcontinent. The Indian subcontinent patients, in comparison with the Middle Eastern Arabs, were younger (49 vs 60 years; P < .001), more were males (96% vs 80%; P < .001), had lower proportion of higher Global Registry of Acute Coronary Events risk score (8% vs 27%; P < .001), and less likely to be associated with diabetes (34% vs 42%; P < .001), hypertension (36% vs 51%; P < .001), and hyperlipidemia (29% vs 39%; P < .001) but more likely to be smokers (55% vs 29%; P < .001). After multivariable adjustment, the Middle Eastern Arabs were less likely to be associated with in-hospital congestive heart failure (odds ratio [OR], 0.65; 95% confidence interval [CI]: 0.50-0.86; P = .003) but more likely to be associated with recurrent ischemia (OR 1.33; 95% CI: 1.03-1.71; P = .026) when compared to the Indian subcontinent patients. Despite the baseline differences, there were largely no significant differences in in-hospital outcomes between the Indians and the Middle Eastern Arabs.

Initial heart rate and cardiovascular outcomes in patients presenting with acute coronary syndrome.

OBJECTIVES: To assess the impact of on-admission heart rate (HR) in patients presenting with acute coronary syndrome (ACS). METHODS: Data were collected retrospectively from the second Gulf Registry of Acute Coronary Events. Patients were divided according to their initial HR into: (I: < 60, II: 60-69, III: 70-79, IV: 80-89 and V: ≥ 90 bpm). Patients' characteristics and hospital and one- and 12-month outcomes were analyzed and compared. RESULTS: Among 7939 consecutive ACS patients, groups I to V represented 7%, 13%, 20%, 23.5%, and 37%, respectively. Mean age was higher in groups I and V. Group V were more likely males, diabetic and hypertensive. ST-elevation myocardial infarction was the main presentation in groups I and V. Reperfusion therapies were less likely given to group V. Beta blockers were more frequently prescribed to group III in comparison to groups with higher HR. Groups I and V were associated with worse hospital outcomes. Multivariate analysis showed initial tachycardia as an independent predictor for heart failure (OR 2.2; 95%CI: 1.39-3.32), while bradycardia was independently associated with higher one-month mortality (OR 2.0; 95%CI: 1.04-3.85) CONCLUSION: The majority of ACS patients present with tachycardia. However, low or high HR is a marker of high risk that needs more attention and management.

Gender disparities in the presentation, management and outcomes of acute coronary syndrome patients: data from the 2nd Gulf Registry of Acute Coronary Events (Gulf RACE-2).

BACKGROUND: Gender-related differences in mortality of acute coronary syndrome (ACS) have been reported. The extent and causes of these differences in the Middle-East are poorly understood. We studied to what extent difference in outcome, specifically 1-year mortality are attributable to demographic, baseline clinical differences at presentation, and management differences between female and male patients. METHODOLOGY/PRINCIPAL FINDINGS: Baseline characteristics, treatment patterns, and 1-year mortality of 7390 ACS patients in 65 hospitals in 6 Arabian Gulf countries were evaluated during 2008-2009, as part of the 2nd Gulf Registry of Acute Coronary Events (Gulf RACE-2). Women were older (61.3±11.8 vs. 55.6±12.4; P<0.001), more overweight (BMI: 28.1±6.6 vs. 26.7±5.1; P<0.001), and more likely to have a history of hypertension, hyperlipidemia or diabetes. Fewer women than men received angiotensin-converting enzyme inhibitors (ACE), aspirin, clopidogrel, beta blockers or statins at discharge. They also underwent fewer invasive procedures including angiography (27.0% vs. 34.0%; P<0.001), percutaneous coronary intervention (PCI) (10.5% vs. 15.6%; P<0.001) and reperfusion therapy (6.9% vs. 20.2%; P<0.001) than men. Women were at higher unadjusted risk for in-hospital death (6.8% vs. 4.0%, P<0.001) and heart failure (HF) (18% vs. 11.8%, P<0.001). Both 1-month and 1-year mortality rates were higher in women than men (11% vs. 7.4% and 17.3% vs. 11.4%, respectively, P<0.001). Both baseline and management differences contributed to a worse outcome in women. Together these variables explained almost all mortality disparities. CONCLUSIONS/SIGNIFICANCE: Differences between genders in mortality appeared to be largely explained by differences in prognostic variables and management patterns. However, the origin of the latter differences need further study.

Clinical Profile and Mortality of ST-Segment Elevation Myocardial Infarction Patients Receiving Thrombolytic Therapy in the Middle East.

OBJECTIVE: Little is known about thrombolytic therapy patterns in patients with ST-elevation myocardial infarction (STEMI) in the Middle East. The objective of this study was to evaluate the clinical profile and mortality of STEMI patients who arrived in hospital within 12 hours from pain onset and received thrombolytic therapy. PATIENTS AND METHODS: This was a prospective, multinational, multi-centre, observational survey of consecutive acute coronary syndrome patients admitted to 65 hospitals in six Middle Eastern countries during the period between October 2008 and June 2009, as part of Gulf RACE-II (Registry of Acute Coronary Events). Analyses were performed using univariate statistics. RESULTS: Out of 2,465 STEMI patients, 66% (n = 1,586) were thrombolysed with namely: streptokinase (43%), reteplase (44%), tenecteplase (10%), and alteplase (3%). 22.7% received no reperfusion. Median age of the study cohort was 50 (45-59) years with majority being males (91%). The overall median symptom onset-to-presentation and door-to-needle times were 165 (95- 272) minutes and 38 (24-60) minutes, respectively. Generally, patients presenting with higher GRACE risk scores were treated with newer thrombolytic agents (reteplase and tenecteplase) (P < 0.001). The use of newer thrombolytic agents was associated with a significantly lower mortality at both 1-month (0.8% vs. 1.7% vs. 4.2%; P = 0.014) and 1-year (0% vs. 1.7% vs. 3.4%; P = 0.044) compared to streptokinase use. CONCLUSIONS: Majority of STEMI patients from the Middle East were thrombolysed with streptokinase and reteplase in equal numbers. Nearly one-fifth of patients did not receive any reperfusion therapy. There was inappropriately long symptom-onset to hospital presentation as well as door-to-needle times. Use of newer thrombolytic agents in high risk patients was appropriate. Newer thrombolytic agents were associated with significantly lower mortality at 1-month and 1-year compared to the older agent, streptokinase.

Are acute coronary syndrome patients admitted during off-duty hours treated differently? An analysis of the Saudi Project for Assessment of Acute Coronary Syndrome (SPACE) study.

BACKGROUND AND OBJECTIVES: It is often suggested that acute coronary syndrome (ACS) patients admitted during off-duty hours (OH) have a worse clinical outcome than those admitted during regular working hours (RH). Our objective was to compare the management and hospital outcomes of ACS patients admitted during OH with those admitted during RH. DESIGN AND SETTING: Prospective observational study of ACS patients enrolled in the Saudi Project for Assessment of Acute Coronary Syndrome study from December 2005 to December 2007. PATIENTS AND METHODS: ACS patients with available date and admission times were included. RH were defined as weekdays, 8 AM-5 PM, and OH was defined as weekdays 5 PM-8 AM, weekends, during Eid (a period of several days marking the end of two major Islamic holidays), and national days. RESULTS: Of the 2825 patients qualifying for this analysis, 1016 (36%) were admitted during RH and 1809 (64%) during OH. OH patients were more likely to present with heart failure and ST elevation myocardial infarction (STEMI) and to receive fibrinolytic therapy, but were less likely to undergo primary percutaneous coronary interventions (PCI). The median door to balloon time was significantly longer (P<.01) in OH patients (122 min) than in RH patients. No differences were observed in hospital outcomes including mortality between the two groups, except for higher heart failure rates in OH patients (11.1% vs 7.2%, P<.001). CONCLUSIONS: STEMI patients admitted during OH were disadvantaged with respect to use and speed of delivery of primary PCI but not fibrinolytic therapy. Hospitals providing primary PCI during OH should aim to deliver it in a timely manner throughout the day.

Prior antiplatelet use and cardiovascular outcomes in patients presenting with acute coronary syndromes.

BACKGROUND: Although antiplatelet therapy effectively reduces ischemic events, the cardiovascular (CV) outcome in some cases is still unpredictable. OBJECTIVE: The objective of this study was to evaluate the impact of prior single or dual antiplatelet (PAP) use in patients presenting with acute coronary syndromes (ACS). METHODS: Data were collected from the 2nd Gulf Registry of Acute Coronary Events between October 2008 and June 2009. Patients were grouped according to whether they were PAP users or not (NAP). Patients' characteristics and outcomes were analyzed and compared. Mortality was assessed at 1 and 12 months. RESULTS: Among 7827 consecutive ACS patients, 41% were PAP users (70% aspirin, 1% clopidogrel, and 29% dual antiplatelet agents). In comparison with NAP use, PAP use was associated with a higher rate of co-morbidities, atypical presentation, severe left ventricular dysfunction, three-vessel disease, and a high GRACE risk score. After adjustment for relevant covariates, PAP use was an independent predictor for recurrent ischemia in unstable angina (odds ratio [OR] 1.7; 95% CI 1.17, 2.57) and non-ST-elevation myocardial infarction (NSTEMI) [OR 1.9; 95% CI 1.38, 2.65] and for heart failure in NSTEMI (OR 1.5; 95% CI 1.11, 2.15) and STEMI (OR 1.4; 95% CI 1.08, 1.93). Although PAP use was associated with high mortality in STEMI and NSTEMI, it was not an independent predictor for mortality. Among PAP patients, percutaneous coronary intervention independently reduced the risk of hospital (adjusted OR 0.25; 95% CI 0.20, 0.32), 1-month (OR 0.31; 95% CI 0.26, 0.37), and 12-month mortality (OR 0.28; 95% CI 0.24, 0.33). CONCLUSION: PAP use identified a high-risk population across the ACS spectrum. Early coronary revascularization may improve CV outcomes in these patients.

In-hospital adverse clinical outcomes of ST elevation myocardial infarction patients with renal dysfunction. Insights from the Saudi Project for Assessment of Coronary Events.

OBJECTIVE: To explore the prognostic value of baseline estimated glomerular filtration rate (eGFR) in Saudi patients presenting with ST elevation myocardial infarction (STEMI), and its impact on hospital therapies. METHODS: The STEMI patients with a baseline serum Creatinine enrolled in the SPACE (Saudi Project for Assessment of Coronary Events) registry were analyzed. This study was performed in several regions in Saudi Arabia between December 2005 to December 2007. Based on eGFR levels, patients were classified into: more than 90.1 ml/min (normal renal function), 90-60.1 (borderline/mildly impaired renal function), 60-30 (moderate renal dysfunction), and less than 30 ml/min/1.73 m2 (severe renal dysfunction). RESULTS: Two thousand and fifty-eight patients qualified for this study. Of these, 1058 patients had renal dysfunction. Patients with renal dysfunction were older, and had a higher prevalence of risk factors for atherosclerosis. Patients with moderate or severe renal dysfunction were less likely to be treated with beta blockers, angiotensin converting enzymes inhibitors, statins, or reperfusion therapies. Significantly worse outcomes were seen with lower eGFR in a stepwise fashion. The adjusted odds ratio of in-hospital death in patients with eGFR less than 30 ml/min was 5.3 (95% CI, 1.15-25.51, p=0.0383). CONCLUSION: A low baseline eGFR in STEMI patients is an independent predictor of all major adverse cardiovascular outcomes, and a marker for less aggressive in-hospital therapy.

Diagnostic yield and therapeutic impact of transthoracic echocardiography in patients with potential cardiac sources of cerebral embolism.

OBJECTIVE: To explore the diagnostic yield of transthoracic echocardiography (TTE), and assess the effect of echocardiographic findings on subsequent therapy. METHODS: In this retrospective study, we reviewed TTE reports and hospital records of patients diagnosed with a stroke or transient ischemic attack (TIA), screening for potential cardiac sources of embolism (CSE) from January 2006 to December 2008 at King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia by considering at least 15 predefined TTE criteria. The therapeutic interventions employed as a consequence of the TTE findings were sought. RESULTS: We analyzed 240 patients (mean patient age 58.514) out of 10563 TTEs. While only one patient exhibited a definite CSE on TTE, potential CSEs were found in 35 patients (14.6%), most commonly caused by left ventricular (LV) systolic dysfunction (31.4%), followed by LV regional wall motion abnormalities (25.7%). Multivariate analysis revealed 2 independent predictors for identifying a CSE on TTE: history of coronary artery disease (odds ratio [OR] 6.2, 95% confidence interval [CI]:2.6-14.8, p=0.0001), and nationality (OR 0.16, 95% CI: 0.3-0.7, p=0.019). The TTE findings affected therapy in only 3 patients (1.2%). CONCLUSION: The TTE performed to exclude a CSE in patients with stroke or TIA resulted in low diagnostic yield, and had little impact on therapeutic decisions. Future refinement of clinical strategies to predict a CSE is needed to improve diagnosis, and possibly cost-effectiveness, of TTE.

Detailed disclosure to Saudi Arabian patients on risks related to an invasive procedure.

OBJECTIVE: To measure the effect of providing a detailed description of coronary angiography risks on obtaining informed consent from Saudi Arabian patients. METHODS: This randomized controlled trial was conducted at King Khalid University Hospital, Riyadh, Saudi Arabia from August 2006 to June 2007. Patients were randomized to either an information sheet containing brief information on procedure-related risks (brief sheet), or full disclosure of risks (detailed sheet). Both groups completed a brief questionnaire following exposure to either sheet. Primary endpoint was refusal to consent to coronary angiography. Secondary endpoints were anxiety following exposure to the detailed sheet and appropriateness of the amount of risk disclosure contained in both information sheets. RESULTS: One hundred and six Saudi patients were enrolled, 6 patients were later excluded. Mean age was 58 years; 45 patients (45%) were illiterate. Fifty-three patients were randomized to the brief sheet, and 47 to the detailed sheet. Only one patient (1.8%) given the brief sheet refused consent, compared to 5 patients (10.6%) given the detailed sheet (p=0.06, 95% confidence interval 1.2 to 2.8). Ninety-four patients responding to the questionnaire felt that the information given was enough, including all of the patients randomized to the brief sheet. Twenty-two patients randomized to the detailed sheet indicated increased anxiety after hearing procedure-related risks. CONCLUSION: We found no significant difference in consent status between the detailed and brief disclosure of procedure-related risk groups. Most patients did not require detailed risk disclosure.

Prosthesis-patient mismatch after aortic valve replacement predominantly affects patients with preexisting left ventricular dysfunction: effect on survival, freedom from heart failure, and left ventricular mass regression.

OBJECTIVE: The effect of prosthesis-patient mismatch on clinical outcome and left ventricular mass regression after aortic valve replacement remains controversial. Data on whether the clinical effect of prosthesis-patient mismatch depends on left ventricular function at the time of aortic valve replacement are lacking. This study examined the long-term clinical and echocardiographic effects of prosthesis-patient mismatch in patients with and without left ventricular systolic dysfunction at the time of aortic valve replacement. METHODS: Preoperative and serial postoperative echocardiograms were performed in 805 adults who underwent aortic valve replacement between 1990 and 2003 and who were subsequently followed up in a dedicated valve clinic (follow-up, mean +/- SD, 5.5 +/- 3.5 years; maximum, 14.2 years). Preoperative left ventricular function was defined as normal (ejection fraction > or =50%) in 548 patients and impaired (ejection fraction <50%) in 257 patients. RESULTS: Patients with impaired preoperative left ventricular function and prosthesis-patient mismatch (indexed effective orifice area < or =0.85 cm2/m2) had a decreased overall late survival (hazard ratio, 2.8; P = .03), decreased freedom from heart failure symptoms or heart failure death (odds ratio of 5.1 at 3 years after aortic valve replacement; P = .009), and diminished left ventricular mass regression compared with patients with impaired preoperative left ventricular function and no prosthesis-patient mismatch. These effects of prosthesis-patient mismatch were not observed in patients with normal preoperative left ventricular function. CONCLUSIONS: Prosthesis-patient mismatch at an indexed effective orifice area of 0.85 cm2/m2 or less after aortic valve replacement primarily affects patients with impaired preoperative left ventricular function and results in decreased survival, lower freedom from heart failure, and incomplete left ventricular mass regression. Patients with impaired left ventricular function represent a critical population in whom prosthesis-patient mismatch should be avoided at the time of aortic valve replacement.