Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: A Community Hospital Pilot Study.

BACKGROUND: Patients with heart failure with preserved ejection fraction (HFpEF) experience poor exercise tolerance and quality of life. Little is known about the feasibility or effects of HFpEF exercise training (ET) in a community hospital setting. OBJECTIVE: The aim of this study was to examine the feasibility and pilot data of a community-based HFpEF ET intervention. METHODS: This was a single-group (n = 16), pretest-posttest, 9-week ET intervention. The Minnesota Living With Heart Failure Questionnaire, Patient Health Questionnaire-9, cardiopulmonary exercise test (peak VO2), and 6-minute walk test were used for evaluation. RESULTS: Participants (n = 16) attended 88% of prescribed ET sessions and 94% completed all pretest-posttest assessments. Significant improvements in Minnesota Living With Heart Failure Questionnaire (P = .01), Patient Health Questionnaire-9 (P ≤ .01), exercise test time (P = .01) and 6-minute walk test (P = .001), but not in peak VO2 (P = .16), were found. CONCLUSIONS: The ET intervention was feasible and safe, and findings support improved quality of life, depressive symptoms, and exercise tolerance. Larger controlled trials are warranted.

Differential outcomes after sirolimus-eluting stent implantation: comparing on-label versus off-label patients in the 'real world'.

BACKGROUND: Randomized controlled trials indicate that sirolimus-eluting stents (SES) reduce the rates of restenosis and need for subsequent revascularization procedures, but patients enrolled in randomized trials represent a highly selected population. This study examined the performance of SES in a 'real world' setting by comparing the outcomes of trial-eligible versus ineligible patients undergoing percutaneous coronary intervention. METHODS: From the US commercial introduction of SES in April 2003 until December 2003, all patients that received an SES at our institution were followed in a prospective registry (n=838). For the purpose of this analysis, the registry population was divided into two groups based on the inclusion and exclusion criteria of the stenosis in a native coronary artery (SIRIUS) trial. The primary endpoint of the study was the rate of target lesion revascularization (TLR) at follow-up. Secondary endpoints included major adverse cardiac events (MACE) such as cardiac death, myocardial infarction, and target vessel revascularization. Clinical follow-up was complete for 92% of patients with a median duration of 14.2 months. RESULTS: Overall, 296 patients (35.3%) met entry criteria for the SIRIUS trial and thus comprised the SIRIUS eligible group. Patients in the SIRIUS ineligible group (n=542) were more likely to have chronic kidney disease and earlier bypass surgery and had longer mean stent length. At 1 year, TLR occurred in 3.0% of the SIRIUS eligible population and in 9.2% of the SIRIUS ineligible group (P=0.001). The secondary endpoint of cumulative MACE occurred in 6.6% of the SIRIUS eligible versus in 17.7% of the SIRIUS ineligible population (P<0.001). Two patients (0.4%) in the SIRIUS ineligible group had a late stent thrombosis on days 39 and 99, respectively, versus none in the SIRIUS eligible group. CONCLUSION: Among 'real world' patients treated with SES, the incidence of TLR and MACE at 1 year was substantially greater among SIRIUS ineligible patients compared with SIRIUS eligible patients. These findings confirm that pivotal clinical trials of drug-eluting stents tend to enroll low-risk patients and that the estimated rates of TLR and MACE derived from such trials may not reflect subsequent outcomes with unrestricted clinical use.

Comparison of outcomes using sirolimus-eluting stenting in diabetic versus nondiabetic patients with comparison of insulin versus non-insulin therapy in the diabetic patients.

The effect of insulin therapy on adverse cardiovascular outcomes in diabetic patients has been debated and a reduced benefit in clinical restenosis outcomes after sirolimus stenting has been reported among diabetic patients requiring insulin therapy. We analyzed 297 diabetic patients receiving sirolimus-eluting stents, including 115 (39%) on insulin therapy, and compared outcomes with 541 nondiabetic patients treated consecutively during the same interval. The rates of target lesion revascularization (9.5% vs 3.5%, p = 0.003) and cardiac death or myocardial infarction (MI, 7.1% vs 3.1%, p = 0.012) were significantly higher for diabetic patients. Insulin treatment was independently associated with increased risk for target lesion revascularization (odds ratio [OR] 2.48, 95% confidence interval [CI] 1.22 to 5.00) and cardiac death or MI (hazard ratio [HR] 2.85, 95% CI 1.41 to 5.77), whereas the adjusted risk for diabetic patients not treated with insulin was not significantly different from patients without diabetes for target lesion revascularization (OR 1.32, 95% CI 0.66 to 2.62) or cardiac death or MI (HR 1.04, 95% CI 0.50 to 2.17). In conclusion, diabetes mellitus is associated with increased risk for target lesion revascularization and cardiac death or MI after receiving sirolimus-eluting stenting, and is significantly exaggerated by the requirement for insulin therapy.

Suture-mediated closure of a patent foramen ovale during surgery without cardiopulmonary bypass.

A patent foramen ovale (PFO) is associated with an increased risk of recurrent ischemic strokes and transient ischemic attacks due to paradoxical emboli in patients with prior neurological events. We report a case of a surgical suture-mediated of a PFO closure without cardiopulmonary bypass in a patient with recurrent cerebral ischemic events, who was intolerant of medical therapy, was a poor candidate for catheter-based PFO closure, and presented as a potentially high risk for poor wound healing from traditional surgical closure.

Effect of diabetes mellitus on five-year clinical outcomes after single-vessel coronary stenting (a pooled analysis of coronary stent clinical trials).

Diabetes mellitus (DM) increases the risk of clinically driven, repeat revascularization of the stented lesion in the first year after coronary stenting. The effect of DM on the risk of repeat revascularization of the stented lesion beyond 1 year, revascularization at other coronary sites, and clinical outcomes of cardiac death and myocardial infarction (MI) has not been reported. We pooled primary data from 4 multicenter trials of second-generation coronary stents that included 1,228 patients, 263 of whom (21%) had DM. Patients were followed annually to assess for prespecified end points, including repeat revascularization procedures, death, or MI. Repeat revascularization of the stented lesion was performed more frequently during the first year in patients with DM (16.0% vs 10.9%, p = 0.01) but decreased to a low frequency (1.8% vs 1.3% per year) thereafter in patients with and without DM. Repeat revascularization of other coronary segments was more frequent in patients with DM during the first and subsequent years (5-year rates, 32.2% vs 24.1%, p = 0.005). Cardiac death or MI was also more frequent among patients with DM (5-year rates, 25.4% vs 17.9%, p = 0.008) and remained significant after adjustment for all differences in baseline characteristics (hazard ratio 1.5, 95% confidence interval 1.1 to 2.0, p = 0.01). In conclusion, diabetic patients are at increased risk for revascularization of the stented lesion only in the first year after single-lesion stenting but are at increased risk for other clinical events, including cardiac death and MI, over the next 4 years.

The association between blood pressure and mortality in patients with heart failure.

BACKGROUND: The association between low blood pressure and prognosis in the general population has been controversial, with some reports suggesting an increased mortality for patients with the lowest blood pressures. Whereas many standard heart failure therapies decrease blood pressure, the relationship between mortality and blood pressure in patients with heart failure has not been previously evaluated. METHODS: We used the Digitalis Investigation Group trial database to evaluate retrospectively the relationship among systolic blood pressure (SBP), diastolic blood pressure (DBP), and survival among 5747 patients with New York Heart Association class II or III heart failure and left ventricular ejection fraction < or = 0.45. Cox proportional hazards models were used to identify covariates predictive of long-term mortality. RESULTS: The adjusted all-cause mortality rate during the entire study period for patients in the lowest SBP group (< 100 mm Hg) was 50% and was significantly higher than that of the reference group of patients with SBP of 130 to 139 mm Hg, which had a mortality rate of 32% (hazard ratio 1.65, 95% CI 1.25-2.17, P < .001). The relationship between SBP and mortality was significant (P < .001) and nonlinear (P = .009). The relationship between DBP and mortality was significant (P < .001), with the highest mortality seen in patients with DBP < 60 mm Hg. CONCLUSIONS: In patients with systolic dysfunction (left ventricular ejection fraction < or = 0.45) and New York Heart Association classes II and III symptoms, lower SBPs and DBPs were associated with greater mortality.