6 research outputs found
Obasanjo and the verdict of history: an assessment of Obasanjo’s administration in Nigeria 1999-2007
The history of modern Nigeria cannot be complete without a mention of Chief Olusegun Obasanjo. This is certainly because of the roles he had played in the leadership of Nigeria. He ruled Nigeria as a military Head of State from 1976 to 1979 and as a civilian president from 1999-2007, a feat no other Nigerian had accomplished.
The essence of this paper is to ascertain the verdict of history on Obasanjo as a military Head of State and more especially as a civilian president from 1999-2007. His term as a civilian president was a major litmus test for the future of Nigeria’s fledgling democracy. Set as a critical conjecture characterized by high popular expectation and international goodwill on the one hand, and weak institutions and deep seated social cleavages exacerbated by years of military rule on the other, his administration was expected to quickly deliver the dividends of democracy. How far did he go and how positively or negatively had he impacted on Nigerians and the Nigerian nation
Transcatheter or surgical aortic-valve replacement in intermediate-risk patients
BACKGROUND:
Previous trials have shown that among high-risk patients with aortic stenosis, survival
rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aorticvalve
replacement. We evaluated the two procedures in a randomized trial involving
intermediate-risk patients.
METHODS:
We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57
centers, to undergo either TAVR or surgical replacement. The primary end point was death
from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would
not be inferior to surgical replacement. Before randomization, patients were entered into
one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were
included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.
RESULTS:
The rate of death from any cause or disabling stroke was similar in the TAVR group and
the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event rates
were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR
group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoralaccess
cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery
(hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access
cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve
areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding,
and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications
and less paravalvular aortic regurgitation.
CONCLUSIONS:
In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with
respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences;
PARTNER 2 ClinicalTrials.gov number, NCT01314313
Outcomes in 937 Intermediate-Risk Patients Undergoing Surgical Aortic Valve Replacement in PARTNER-2A.
BACKGROUND: The Placement of Aortic Transcatheter Valves 2A (PARTNER-2A) randomized trial compared outcomes of transfemoral transcatheter and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the present study was to perform an in-depth analysis of outcomes after SAVR in the PARTNER-2A trial.
METHODS: From January 2012 to January 2014, 937 patients underwent SAVR at 57 centers. Mean age was 82 ± 6.7 years and 55% were men. Less-invasive operations were performed in 140 patients (15%) and concomitant procedures in 198 patients (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years.
RESULTS: Operative mortality was 4.1% (n = 38, Society of Thoracic Surgeons predicted risk of mortality: 5.2% ± 2.3%), observed to expected ratio (O/E) was 0.8, and in-hospital stroke was 5.4% (n = 51), twice expected. Aortic clamp and bypass times were 75 ± 30 minutes and 104 ± 46 minutes, respectively. Patients having severe prosthesis-patient mismatch (n = 260, 33%) had similar survival to patients without (p \u3e 0.9), as did patients undergoing less-invasive SAVR (p = 0.3). Risk factors for death included cachexia (p = 0.004), tricuspid regurgitation (p = 0.01), coronary artery disease (p = 0.02), preoperative atrial fibrillation (p = 0.001), higher white blood cell count (p \u3c 0.0001), and lower hemoglobin (p = 0.0002).
CONCLUSIONS: In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment after the procedure. No pronounced structural valve deterioration was found during 2-year follow-up. Continued long-term surveillance remains important
Transcathter aortic valve replacement versus surgical valve replacement in intermediate-risk patients : a propensity score analysis
Background: Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical
outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report
longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediaterisk
patients given surgical aortic valve replacement.
Methods: In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were
assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and
Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic
valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for
intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011,
and Nov 6, 2013, using a prespecifi ed propensity score analysis to account for between-trial diff erences in baseline
characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both
studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or
severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score
quintiles to calculate pooled weighted proportion diff erences for outcomes.
Findings: At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure
had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in
24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the
propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve
replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation,
TAVR was both non-inferior (pooled weighted proportion diff erence of –9·2%; 90% CI –12·4 to –6; p<0·0001) and
superior (–9·2%, 95% CI –13·0 to –5·4; p<0·0001) to surgical valve replacement.
Interpretation: TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low
mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a signifi cant superiority for our
composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment
alternative in intermediate-risk patients
Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.
BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.
METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.
RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.
CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)