Gulf implantable cardioverter-defibrillator registry: rationale, methodology, and implementation

Background: The implantable cardioverter-defibrillator [ICD] is effective in the prevention of sudden cardiac death in high-risk patients. Little is known about ICD use in the Arabian Gulf. We designed a study to describe the characteristics and outcomes of patients receiving ICDs in the Arab Gulf region

Methods: Gulf ICD is a prospective, multi-center, multinational, and observational study. All adult patients 18 years or older, receiving a de novo ICD implant and willing to sign a consent form will be eligible. Data on baseline characteristics, ICD indication, procedure and programing, in-hospital, and 1-year outcomes will be collected. Target enrollment is 1500 patients, which will provide adequate precision across a wide range of expected event rates

Results: Fifteen centers in six countries are enrolling patients [Saudi Arabia, United Arab Emirates, Kuwait, Oman, Bahrain, and Qatar]. Two-thirds of the centers have dedicated electrophysiology laboratories, and in almost all centers ICDs are implanted exclusively by electrophysiologists. Nearly three-quarters of the centers reported annual ICD implant volumes of

Conclusions: Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region

Prospective observational studies of the management and outcomes in patients with atrial fibrillation: a systematic review

Atrial fibrillation [AF] is a major global public health problem. Observational studies are necessary to understand patient characteristics, management, and outcomes of this common arrhythmia. Accordingly, our objective was to describe the current status of published prospective observational studies of AF. MEDLINE and EMBASE [to June 2012] and reference lists of eligible studies were searched for English-language prospective observational registries of AF [n >/= 100 and follow-up >/= 6 months]. Two reviewers independently extracted data. Disagreements were resolved by consensus. Eight prospective studies enrolled a total of 17,924 patients with AF [total 41,306 patient-years of exposure; follow-up 11 months to 9.9 years]. The majority of subjects were enrolled in Europe [74%] or North America [21%], and 0.3% had rheumatic AF. The most consistently reported comorbidities were diabetes mellitus [range 5-18%], hypertension [39-68%], heart failure [5-58%], and prior stroke [4-17%]. Three studies did not report all the variables necessary to calculate the currently recommended stroke risk assessment score, and no study reported all the variables required to calculate a recently validated bleeding risk score. The most consistently reported management features were oral anticoagulation [32-64%] and aspirin [28-61%] use. Calcium channel blockers were less frequently used than other rate controlling agents, and digoxin was most common in the single study from Africa [63%]. Total mortality was reported in all studies, while data on stroke/systemic embolism, hospitalizations, and major hemorrhage rates were not always reported. Current literature on real-world management of AF is relatively limited with inadequate data to allow detailed comparisons among reports. Data on rheumatic AF and from Africa and the developing world in general are sparse.

Incidence of ventricular arrhythmia and associated patient outcomes in hospitalized acute coronary syndrome patients in Saudi Arabia: findings from the registry of the Saudi Project for Assessment of Acute Coronary Syndrome [SPACE]

Mortality in acute coronary syndrome [ACS] patients with ventricular arrhythmia [VA] has been shown to be higher than those without VA. However, there is a paucity of data on VA among ACS patients in the Middle Eastern countries. Prospective study of patients admitted in 17 government hospitals with ACS between December 2005 and December 2007. Patients were categorized as having VA if they experienced either ventricular fibrillation [VF] or sustained ventricular tachycardia [VT] or both. Of 5055 patients with ACS enrolled in the SPACE registry, 168 [3.3%] were diagnosed with VA and 151 [98.8%] occurred in-hospital. The vast majority [74.4%] occurred in patients with ST-segment elevation myocardial infarction. In addition, males were twice as likely to develop VA than females [OR 1.7; 95% CI 1.1- 3]. Killip class >I [OR 2.0; 95% CI 1.3-3.1]; and systolic blood pressure <90 mm Hg [OR 6.4; 95% CI 3.5-11.8] were positively associated with VA. Those admitted with hyperlipidemia [OR 0.49; 95% CI 0.3-0.7] had a lower risk of developing VA. Adverse in-hospital outcomes including re-myocardial infarction, cardiogenic shock, congestive heart failure, major bleeding, and stroke were higher for patients with VA [P?.01 for all variables] and signified a poor prognosis. The in-hospital mortality rate was significantly higher in VA patients compared with non-VA patients [27% vs 2.2%; P=.001]. In-hospital VA in Saudi patients with ACS was associated with remarkably high rates of adverse events and increased in-hospital mortality. Using a well-developed registry data with a large number of patients, our study documented for the first time the prevalence and risk factors of VA in unselected population of ACS

In-hospital adverse clinical outcomes of ST elevation myocardial infarction patients with renal dysfunction

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. 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 m[2] [severe renal dysfunction]. 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 30ml/min was 5.3 [95% CI, 1.15-25.51,p=0.0383]. 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

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

To measure the effect of providing a detailed description of coronary angiography risks on obtaining informed consent from Saudi Arabian patients. 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. 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. 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