Short-Term Clinical Outcomes of Transcatheter Aortic Valve Replacement in a Developing Country.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis in all surgical risk groups. Reports of clinical outcomes post-TAVR in developing countries are scarce. We aimed to address the clinical outcomes and safety profile of TAVR in a developing country. METHODS: We conducted a single-center, retrospective study on patients undergoing TAVR at the American University of Beirut Medical Center (AUBMC) from January 2016 to April 2023. We included a total of 399 patients. Our primary endpoint was to assess the rate of TAVR in-hospital and 30-day mortality, neurologic events, and new permanent pacemaker implantation (PPI) in patients, stratified by the Society of Thoracic Surgeons (STS) risk of mortality score. RESULTS: Survival rates were 98.7% (394) at discharge vs. 97.5% (389) at 30 days post-procedure. The technical success rate was 95% (379) at the end of the procedure. Device success and early safety rates were 93.5% (373) and 83% (331), respectively at 30 days post-procedure. The all-cause mortality rate increased from 1.3% (5) at discharge to 2.5% (10) at 30-day intervals. The rate of ischemic stroke was 1.3% (five) at discharge and increased to 2% (eight) at 30 days post-procedure. PPI was needed in 5.8% (23) of patients at discharge with an increase to 7% (28) at one-month interval. Overall, the rates of TAVR outcomes among the three risk groups were comparable including neurologic events, valve-related complications, bleeding problems, vascular and access-related complications, and myocardial infarction. CONCLUSION: This study at AUBMC highlights the successful implementation of the TAVR program in a developing country, showcasing its efficacy and safety within 30 days post-operation, despite challenges such as financial constraints and limited access to specialized training. Larger cohorts and longer follow-up periods are needed to accurately represent clinical outcomes in developing countries.

Structural valve deterioration of the Labcor Dokimos aortic prosthesis: a single-centre experience.

OBJECTIVES: The goal of this study was to assess the performance and incidence of the deterioration of the Labcor Dokimos bioprosthetic aortic valve. METHODS: We performed a retrospective medical chart review of 116 patients who underwent surgical aortic valve replacement with the Labcor Dokimos aortic valve between 2010 and 2018. Abstracted data included patient demographic and echocardiographic data. Patients were divided into 2 groups: patients with structural valve deterioration (SVD) and patients without SVD. RESULTS: Among the patients with complete follow-up (n = 95), 10 patients were excluded because they died within a year; 85 patients were included in the final analysis. Of the 85 patients, 32 (38%) developed SVD; 22 (26%) had severe SVD, 15 (18%) of whom underwent reintervention. The most common aetiology of SVD was severe central aortic regurgitation, which was detected in 91% of the patients who had severe SVD. The average time from operation to severe SVD was 4.7 years with a minimum of 1.5 years and a maximum of 7.9 years. CONCLUSIONS: Bioprosthetic aortic valve deterioration due to severe aortic regurgitation is common and occurs early with the Labcor Dokimos valve. This occurrence needs to be furthered investigated in larger registries.

EAPCI Core Curriculum for Percutaneous Cardiovascular Interventions (2020): Committee for Education and Training European Association of Percutaneous Cardiovascular Interventions (EAPCI). A branch of the European Society of Cardiology.

The proposed 2020 Core Curriculum for Percutaneous Cardiovascular Interventions aims to provide an updated European consensus that defines the level of experience and knowledge in the field of percutaneous cardiovascular intervention (PCI). It promotes homogenous education and training programmes among countries, and is the cornerstone of the new EAPCI certification, designed to support the recognition of competencies at the European level and the free movement of certified specialists in the European Community. It is based on a thorough review of the ESC guidelines and of the EAPCI textbook on percutaneous interventional cardiovascular medicine. The structure of the current core curriculum evolved from previous EAPCI core curricula and from the "2013 core curriculum of the general cardiologist" to follow the current ESC recommendations for core curricula. In most subject areas, there was a wide - if not unanimous - consensus among the task force members on the training required for the interventional cardiologist of the future. The document recommends that acquisition of competence in interventional cardiology requires at least two years of postgraduate training, in addition to four years devoted to cardiology. The first part of the curriculum covers general aspects of training and is followed by a comprehensive description of the specific components in 54 chapters. Each of the chapters includes statements of the objectives, and is further subdivided into the required knowledge, skills, behaviours, and attitudes.

Acute Coronary Syndrome in a Male with Elevated Anti-Cyclic Citrullinated Peptide and no Evidence of Longstanding Rheumatoid Arthritis.

A 55-year-old male, previously known to be healthy, presented to the emergency department with a 30-minute history of chest pain radiating to the upper extremities. Vital signs were within normal limits. Four days prior to this presentation, the patient presented for acute onset of polyarthritis and morning stiffness. Significantly elevated titres of anti-cyclic citrullinated peptides (anti-CCP) were found. In the emergency department, electrocardiography showed ST segment elevations in leads V1 to V5 and aVL. Cardiac enzymes were elevated. The patient underwent cardiac catheterization. A coronary angiography revealed an ectatic proximal left anterior descending (LAD) coronary artery with critical (90-99%) stenosis at the mid segment. A drug-eluting stent was successfully inserted in the LAD without any residual stenosis. Although it is known that anti-CCP positivity is a key element in the pathogenesis of atherosclerosis in RA patients, this case report adds to the existing body of literature which demonstrates that anti-CCP positivity is an independent risk factor for development of cardiovascular events.

Effects of clopidogrel therapy on oxidative stress, inflammation, vascular function, and progenitor cells in stable coronary artery disease.

BACKGROUND: Traditional cardiovascular risk factors lead to endothelial injury and activation of leukocytes and platelets that initiate and propagate atherosclerosis. We proposed that clopidogrel therapy in patients with stable coronary artery disease imparts a pleiotropic effect that extends beyond antiplatelet aggregation to other atheroprotective processes. METHODS: Forty-one subjects were randomized in a double-blind, placebo-controlled, crossover study to receive either clopidogrel 75 mg daily or placebo for 6 weeks and then transitioned immediately to the other treatment for an additional 6 weeks. We assessed (1) endothelial function as flow-mediated dilation of the brachial artery, (2) arterial stiffness and central augmentation index using applanation tonometry, (3) vascular function as fingertip reactive hyperemia index, (4) inflammation by measuring plasma CD40 ligand and serum high-sensitivity c-reactive protein levels, (5) oxidative stress by measuring plasma aminothiols, and (6) circulating progenitor cells, at baseline and at the end of each 6-week treatment period. RESULTS: Clopidogrel therapy resulted in a significant reduction in soluble CD40 ligand (P = 0.03), a prothrombotic and proinflammatory molecule derived mainly from activated platelets. However, clopidogrel therapy had no effect on endothelial function, arterial stiffness, inflammatory and oxidative stress markers, or progenitor cells. CONCLUSIONS: Our findings suggest a solitary antiplatelet effect of clopidogrel therapy in patients with stable coronary artery disease, with no effect on other subclinical markers of cardiovascular disease risk.

Acute coronary syndromes: clinical characteristics, management, and outcomes at the American University of Beirut Medical Center, 2002-2005.

OBJECTIVES: Data on acute coronary syndromes (ACS) in developing countries is scarce. In this report, we analyze the temporal trends in the management and outcomes of a large series of ACS patients hospitalized at the American University of Beirut Medical Center (AUBMC), a tertiary referral university hospital located in a middle income Middle Eastern developing country. METHODS: A total of 1025 consecutive patients hospitalized and discharged with the diagnosis of ACS were enrolled between 2002 and 2005. The utilization of evidence-based therapies and in-hospital outcomes were determined. RESULTS: The study enrolled 228 patients (22%) with ST-elevation myocardial infarction (STEMI), 275 patients (27%) with non-ST-elevation myocardial infarction (NSTEMI), and 522 patients (51%) with unstable angina. The STEMI group was younger and had a higher percentage of men. The utilization rates of coronary angiography and percutaneous coronary intervention (PCI) were highest in the STEMI group. Comparison to earlier ACS data (1997-1998) from the same hospital, showed an increase in the utilization of reperfusion therapy, coronary angioplasty, bypass surgery, aspirin, beta-blockers, angiotensin-converting enzymes (ACE), angiotensin receptor blockers (ARB), and statins over the past decade (P < .05). This was associated with a significant decrease in hospital mortality (13%-7.7%, P < .01). CONCLUSIONS: This study analyzes one of the largest series of ACS patients reported from a single center in a developing country. The utilization of evidence-based therapies in the management of ACS at AUBMC has improved significantly over the past decade with an associated decrease in hospital mortality.

Usefulness of serum high-density lipoprotein cholesterol level as an independent predictor of one-year mortality after percutaneous coronary interventions.

Low levels of high-density lipoprotein (HDL) cholesterol are a marker of coronary artery disease progression and are associated with cardiovascular events. However, whether low HDL cholesterol is a useful prognostic indicator after percutaneous coronary intervention (PCI) is not known. In a sample of 4,088 patients who underwent PCI we evaluated 1-year mortality and repeat revascularization as a function of baseline HDL levels classified into approximate quartiles of very low (<35 mg/dl), low (35 to 40 mg/dl), medium (41 to 47 mg/dl) and high (48 to 120 mg/dl) HDL cholesterol. Decreasing levels of HDL cholesterol were associated with younger age, male gender, smoking, diabetes mellitus, and a history of bypass surgery (p <0.0001 for all). One-year mortality and coronary revascularization were significantly higher in the very low HDL cholesterol group compared with the other groups (very low HDL cholesterol 6.5% and 25.4%, respectively; low HDL cholesterol 3.1% and 20.8%; medium HDL cholesterol 4.3% and 22.7%; high HDL cholesterol 3.1% and 20.6%, p = 0.0001 and p = 0.007). One-year mortality was significantly higher in men with an HDL cholesterol level <33 mg/dL and in women with an HDL cholesterol level <38 mg/dL. In multivariable analysis, very low HDL was associated with nearly twofold the risk of death after adjusting for other independent predictors of outcome. In conclusion, in patients with coronary artery disease undergoing PCI, a baseline HDL cholesterol level <35 mg/dl is an important prognostic indicator. Baseline HDL cholesterol levels <33 mg/dl for men and <38 mg/dl were associated with higher one-year mortality after PCI.

The evolution of percutaneous coronary intervention: from balloons to drug eluting stents.

Percutaneous coronary balloon angioplasty was pioneered by Andreas Gruentzig who designed and assembled balloon dilatation catheters in his own kitchen. In 1976, he reported the successful application in canine coronary experiments. He performed the first successful coronary angioplasty in a patient in September 1977 in Zurich. The dilation catheter consisted of a balloon attached to a long shaft and a short wire attached to its tip. Since then, remarkable refinement in the technology paved the way for the emergence of new percutaneous coronary devices that include coronary atherectomy catheters, laser and stents. The 1980's and early 1990's was primarily a balloon angioplasty era.

Integrated coronary revascularization with drug-eluting stents: immediate and seven-month outcome.

OBJECTIVE: We sought to demonstrate the safety and feasibility of an integrated coronary revascularization strategy that combines minimally invasive left internal thoracic artery to left anterior descending coronary artery anastomosis with drug-eluting stent implantation to non-left anterior descending coronary artery lesions. METHODS: Over 18 months, 47 consecutive patients with multivessel coronary artery disease underwent thoracoscopic harvesting of the left internal thoracic artery to graft the left anterior descending coronary artery. Anastomoses were constructed by hand, off-pump, and under direct vision through a 4-cm non-rib-spreading, muscle-sparing chest incision. Non-left anterior descending coronary artery lesions were then treated percutaneously using sirolimus- or paclitaxel-eluting stents. Angiographic follow-up was performed in all patients. RESULTS: Within the first 90 days of hospitalizations, there were no deaths, myocardial infarctions, neurologic events, or wound complications. Forty patients underwent left internal thoracic artery to left anterior descending coronary artery grafting, and 7 patients underwent left internal thoracic artery to left anterior descending coronary artery/diagonal sequential grafting for a total of 54 anastomoses. Angiographic patency scores were FitzGibbon A 96.2% (52/54) and FitzGibbon A + B 100% (54/54). A total of 65 drug-eluting stents were implanted in 61 non-left anterior descending coronary artery coronary lesions of which 49.1% (30/61) were type B2 or C lesions, including 5 left main lesions. Diabetes was present in 53.2% of patients (25/47). At a mean follow-up time of 7.0 +/- 4.8 months, the target lesion or vessel repeat revascularization rate was 6.6% (4/61) for drug-eluting stents and 1.9% (1/54) for left internal thoracic artery to left anterior descending coronary artery grafting. One anastomosis required balloon dilation, but no patients have required repeat coronary artery bypass grafting. CONCLUSIONS: Integrated coronary revascularization using drug-eluting stents is feasible and safe. There are sufficient data to justify a randomized comparison of integrated coronary revascularization with standard coronary artery bypass grafting.

Impact of diabetes on five-year outcomes after vein graft interventions performed prior to the drug-eluting stent era.

OBJECTIVE: The aim of this study was to evaluate the differences in 5-year outcomes among diabetic and nondiabetic patients undergoing saphenous vein graft (SVG) percutaneous coronary intervention (PCI) prior to the era of distal protection and drug-eluting stents. BACKGROUND: PCI of native coronary arteries is known to be associated with higher rates of adverse outcomes in diabetic patients compared to nondiabetic patients. However, the impact of diabetes on long-term outcomes after SVG interventions is not as well established. We conducted an evaluation of 5-year outcomes after SVG PCI in the two decades prior to the availability of distal protection devices and drug-eluting stents. METHODS: Data on 2,556 subjects (1,780 nondiabetic and 776 diabetic) undergoing SVG PCI at Emory Hospital from 1981 to 2001 were collected and entered into a computerized database and analyzed for adverse cardiovascular outcomes. RESULTS: Compared to the nondiabetic group, the diabetic group had worse 1-year (87.7% vs. 94.9%; p < 0.0001) and 5-year survival rates (62.9% vs. 78.5%; p < 0.0001). In the subset of patients receiving stents, 5-year survival remained significantly worse in the diabetic group (78.2% vs. 87.1%; p = 0.009). After multivariate analysis, diabetes was an independent predictor of 5-year mortality (hazard ratio = 1.8; 95% CI = 1.5-2.5; p < 0.0001). CONCLUSION: Diabetic patients undergoing vein graft PCI prior to the distal protection and drug-eluting stent era had significantly worse long-term outcomes compared to nondiabetic patients. The effect on long-term outcomes using these newer devices in diabetic subjects undergoing SVG PCI must be established for a true assessment of their impact.

Coronary stent restenosis in patients treated with cilostazol.

BACKGROUND: Restenosis after implantation of coronary artery stents remains a significant clinical problem. We undertook a randomized, double-blind, placebo-controlled trial to determine whether cilostazol, a drug that suppresses intimal proliferation, would reduce renarrowing in patients after stent implantation in native coronary arteries. METHODS AND RESULTS: We assigned 705 patients who had successful coronary stent implantation to receive, in addition to aspirin, cilostazol 100 mg BID or placebo for 6 months; clopidogrel 75 mg daily was administered to all patients for 30 days. Restenosis was determined by quantitative coronary angiography at 6 months. The minimal luminal diameter at 6 months for cilostazol-treated patients was 1.77 mm for the analysis segment (stent plus 5-mm borders) compared with 1.62 mm in the placebo group (P=0.01). Restenosis, defined as > or =50% narrowing, occurred in 22.0% of patients in the cilostazol group and in 34.5% of the placebo group (P=0.002), a 36% relative risk reduction. Restenosis was significantly lower in cilostazol-treated diabetics (17.7% versus 37.7%, P=0.01) and in those with small vessels (23.6% versus 35.2%, P=0.02), long lesions (29.9% versus 46.6%, P=0.04), and left anterior descending coronary artery site (19.3% versus 39.8%, P=0.001). There was no difference in bleeding, rehospitalization, target-vessel revascularization, myocardial infarction, or death. CONCLUSIONS: Treatment with the drug cilostazol resulted in a significantly larger minimal luminal diameter and a significantly lower binary restenosis rate compared with placebo-treated patients. These favorable effects were apparent in patients at high risk for restenosis.

Comparison of outcomes of percutaneous coronary intervention of ostial versus nonostial narrowing of the major epicardial coronary arteries.

Outcomes of percutaneous coronary intervention (PCI) of the ostia of the major epicardial coronary arteries in the modern era of stenting have not been clearly defined. We evaluated data from all PCIs performed from 1998 to 2001 in the proximal segments of the major epicardial coronary arteries entered into a large cardiac database and compared ostial with nonostial PCI outcomes. Of 2,484 patients who underwent PCI of a proximal coronary artery (left anterior descending, left circumflex, or right coronary), 223 patients had ostial narrowing and 2,261 patients had proximal, nonostial narrowing. Baseline characteristics were similar between the 2 groups, except that patients with ostial narrowing tended to be older and have shorter narrowings than did patients with nonostial narrowings. Stenting occurred in 89% of all patients and was similar in patients with ostial or nonostial narrowings. Procedural success was the same for ostial and nonostial PCI (96% vs 95%, p = 0.95). One-year event-free survival rate was lower in patients who underwent ostial PCI (69% vs 80%, p = 0.0019), largely due to a greater need for repeat PCI (19% vs 10%, p <0.0001). Multivariate analysis showed that ostial location, age, angina class, and number of diseased vessels were independent predictors of the occurrence of cardiac events. PCI of ostial narrowings of the major epicardial coronary arteries was relatively safe. However, at 1 year, patients who underwent ostial PCI had an increased rate of repeat revascularization compared with patients who underwent nonostial, proximal PCI.

Angiographic variables predict increased risk for adverse ischemic events after coronary stenting with glycoprotein IIb/IIIa inhibition: results from the TARGET trial.

OBJECTIVES: We sought to assess whether pre-procedural angiographic characteristics are associated with adverse clinical outcomes after coronary stenting with glycoprotein IIb/IIIa inhibition. BACKGROUND: Ischemic complications after balloon angioplasty are associated with pre- and post-procedural angiographic variables. However, in the current era of stenting with IIb/IIIa inhibition, it is unknown whether angiographic features assessed before intervention confer an increased risk of adverse procedural and subsequent clinical outcomes. METHODS: In the Do Tirofiban and ReoPro Give Similar Efficacy Outcomes? Trial (TARGET), 4,809 patients undergoing planned stenting were randomized to tirofiban or abciximab. Baseline demographic, clinical, and angiographic variables were obtained. Clinical end points were recorded at 30 days and six months. The relationship between angiographic variables and adverse clinical outcomes was assessed. RESULTS: Patients with the combination of thrombus, lesion eccentricity, and lesion length >20 mm had a 21.4% composite incidence of death, myocardial infarction, or urgent target vessel revascularization (TVR) at 30 days, compared with 4.2% in those patients without these high-risk features (hazard ratio [HR] 3.24, p < 0.001). After adjustment, the risk was independently associated with thrombus (HR 1.40, p = 0.034), eccentricity (HR 1.67, p < 0.001), and lesion length >20 mm (HR 1.89, p < 0.001). The risk of six-month TVR was independently associated with left anterior descending coronary artery lesions (HR 1.46, p < 0.001), restenotic lesions at baseline (HR 1.58, p = 0.006), and lesion length (HR 1.19, p = 0.03). CONCLUSIONS: Patients with thrombus, eccentric lesions, or lesion length >20 mm are at high risk for ischemic outcomes after coronary stenting, despite IIb/IIIa inhibition. Further research into novel anti-thrombotic therapies or procedural strategies is necessary for these patients.

Prognostic implication of creatine kinase release after elective percutaneous coronary intervention in the pre-IIb/IIIa antagonist era.

BACKGROUND: The significance of mild elevations in cardiac enzymes after an elective percutaneous coronary intervention (PCI) still remains controversial. We evaluated the significance of creatine phosphokinase level (CPK) elevations in a large cohort of patients who had undergone an elective PCI before the IIb/IIIa receptor antagonist era. METHODS: All patients enrolled in the Emory databank from 1981 to 1996 who had an elective PCI were evaluated. We identified 15,637 patients who met our inclusion and exclusion criteria. Patients were divided into 4 groups on the basis of the magnitude of the CPK elevation noted in the post-PCI period: group I (CPK <250 mg/dL, n = 14,512); group II (CPK 250-500 mg/dL, n = 715); group III (CPK 500-750 mg/dL, n = 164); and group IV (CPK >750 mg/dL, n = 246). RESULTS: CPK elevations were associated with a significant increase in the periprocedure angiographic complications. Angiographic complication rates were 14.6%, 30.5%, 40.2%, and 43.5% in groups I, II, III, and IV, respectively (P <.001). Long-term survival also correlated inversely with the magnitude of CPK elevations. The 10-year survival rates were 73%, 71%, 69%, and 55% in groups I, II, III, and IV, respectively (P <.0001). After multivariate analysis to correct for clinical factors, a CPK elevation of at least 3-times normal (group IV) was found to be an independent predictor of diminished 30-day and long-term survival (hazard ratio 1.84, 95% CI 1.41-2.41, P <.0001). Elevations in CPK <3-times normal (groups II and III) were not independently predictive of poor long-term survival. CONCLUSION: A CPK level >3-times normal after an elective PCI is a strong independent predictor of poor long-term prognosis.

Outcomes of repeat revascularization in diabetic patients with prior coronary surgery.

OBJECTIVES: This study evaluated both short- and long-term outcomes of diabetic patients who underwent repeat coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) after initial CABG. BACKGROUND: Although diabetic patients who have multivessel coronary disease and require initial revascularization may benefit from CABG as compared with PCI, the uncertainty concerning the choice of revascularization may be greater for diabetic patients who have had previous CABG. METHODS: Data were obtained over 15 years for diabetic patients undergoing PCI procedures or repeat CABG after previous coronary surgery. Baseline characteristics were compared between groups, and in-hospital, 5-year, and 10-year mortality rates were calculated. Multivariate correlates of in-hospital and long-term mortality were determined. RESULTS: Both PCI (n = 1,123) and CABG (n = 598) patients were similar in age, gender, years of diabetes, and insulin dependence, but they varied in presence of hypertension, prior myocardial infarction, angina severity, heart failure, ejection fraction, and left main disease. In-hospital mortality was greater for CABG, but differences in long-term mortality were not significant (10 year mortality, 68% PCI vs. 74% CABG, p = 0.14). Multivariate correlates of long-term mortality were older age, hypertension, low ejection fraction, and an interaction between heart failure and choice of PCI. The PCI itself did not correlate with mortality. CONCLUSIONS: The increased initial risk of redo CABG in diabetic patients and the comparable high long-term mortality regardless of type of intervention suggest that, except for patients with severe heart failure, PCI be strongly considered in all patients for whom there is a percutaneous alternative.