الفهرس 
Patients and MethodsOnly 14 pages are availabe for public view
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Abstract
his is an observational study conducted at two centers in Egypt: Al-Mokattam and Nasr City Health Insurance Hospitals. The study included patients aged over 55 years with symptomatic severe aortic valve (AV) stenosis who were scheduled to undergo transfemoral TAVI. Severe AS was defined as a mean pressure gradient exceeding 40 mmHg, jet velocity exceeding 4.0 m/s, and valvular orifice area less than 1.0 cm2 or 0.6 cm2/m2. Patients with concurrent percutaneous coronary intervention (PCI) and other combined procedures, life expectancy of less than one year, severe mental disabilities, and insufficient data were excluded from the study.
The following items explain the meaning of R2CHA2DS2-VASc, which was used in the calculation: C stands for congestive heart failure; R2 stands for pre-existing kidney dysfunction (eGFR 60 mL/min/1.73 m2 or serum creatinine > 200 mol/L) or pre-existing conduction abnormality such as right bundle branch block (RBBB) or left bundle branch block (LBBB) on preprocedural ECG; H stands for hypertension; A2 for an age of 75 years or more; D for diabetes mellitus; S2 for ischemic stroke or TIA history; V for vascular disease; A for an age of 65 to 74 years; Sc for the female sex. The highest R2CHA2DS2-VASc score achievable is eleven points.
All patients underwent a full history taking, including age, sex, hypertension, congestive heart failure, stroke, diabetes mellitus (DM), transient ischemic attack (TIA), vascular disease (peripheral artery disease, prior MI, or aortic plaque), thromboembolism, and renal disease. A complete physical examination was conducted for all patients, which included (a) signs of heart failure such as shortness of breath, weakness, fatigue, swelling, rapid or irregular pulse, cough, weight increase, chest discomfort, nausea, and diminished alertness; (b) assessment of peripheral artery disease; and (c) signs of neurological deficit. Various investigations were performed, including renal function tests, hematocrit level, WBC count, platelet count, fasting blood sugar, echocardiography, and CT chest.
The heart team determined the valve selection, and transfemoral access was the default method for TAVR. The procedure was performed under general anesthesia or sedoanalgesia, guided by echocardiography in the cardiac catheterization laboratory. Before the procedure, each patient received 75 mg of aspirin and at least 300 mg of clopidogrel, and heparin was used during the procedure. Clopidogrel was continued for at least one month after surgery, and aspirin was continued as long as possible. Mortality statistics were obtained from Al-Mokattam and Nasr City Health Insurance Hospitals as part of routine clinical practice at a 6-month follow-up. Stroke, bleeding complications, myocardial infarction (MI), acute renal injury, conduction abnormalities, vascular complications, and arrhythmias were categorized as cerebrovascular events.
The results showed that the mean age of the studied patients was 76 ± 4 years, with approximately two-thirds being males (58.6%). DM and hypertension were observed in 35.7% and 60% of the patients, respectively. Only 10% were smokers, and 15.7% had dyslipidemia. Heart failure, cerebrovascular disease, and COPD were present in 32.9%, 8.6%, and 22.9% of the patients, respectively. AF was present in only 5.7% of the patients. The most common NYHA classification was class II (50%), followed by class III (21.4%), class I (18.6%), and class IV (10%).
The mean AV area was 0.7 ± 0.1 cm2, and the mean AV gradient was 50 ± 5 mmHg. The mean LVEF was 50 ± 5%, the mean PASP was 43 ± 6 mmHg, and the mean eGFR was 56 ± 11 ml/min. Bundle branch block was present in 18.6% of the patients. The mean hematocrit was 36 ± 2%, the mean WBC count was 7.5 ± 2.2 103/μl, and the mean platelet count was 239 ± 46 103/μl. The median CHA2DS2-VASc score was 3, ranging from 1 to 7, while the median R2CHA2DS2-VASc score was 4, ranging from 1 to 9. The median EuroScore was 2.76, ranging from 1.23 to 10.08.
Patients who experienced the composite endpoint showed significantly higher prevalence of DM, smoking, dyslipidemia, history of heart failure, cerebrovascular disease, AF, bundle branch block, CHA2DS2-VASc score, R2CHA2DS2-VASc score, and EuroScore II compared to patients who did not experience the composite endpoint. No statistically significant differences were found regarding other parameters.
All patients received sedation during the procedure. Pre-dilatation and post-dilatation were reported in 45.7% and 54.3% of the cases, respectively. The mean implantation depth was 5.29 ± 0.45 mm. Paravalvular leakage occurred in 7.1% of the cases, while major vascular complications and bleeding complications were reported in 2.9% and 4.3% of the cases, respectively. No pericardial tamponade was reported. Acute renal failure was observed in 8.6% of the patients, and a permanent pacemaker was placed in 5.7% of the cases.
Patients who experienced the composite endpoint had s