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- Escaned, Javier, et al.
(författare)
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Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes
- 2018
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Ingår i: JACC. - : Elsevier. - 1936-8798 .- 1876-7605. ; 11:15, s. 1437-1449
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). BACKGROUND Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. METHODS The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. RESULTS Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). CONCLUSIONS Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year. (C) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
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| 2. |
- Götberg, Matthias, et al.
(författare)
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Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART) : Rationale and design of a multicenter, prospective, registry-based randomized clinical trial
- 2015
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Ingår i: American Heart Journal. - : Mosby-Elsevier. - 0002-8703 .- 1097-6744. ; 170:5, s. 945-950
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Tidskriftsartikel (refereegranskat)abstract
- Background: Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up.Design/Methods: iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1: 1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality.Discussion: The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.
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| 3. |
- Sigurdsson, Martin, I, et al.
(författare)
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Association Between Preoperative Opioid and Benzodiazepine Prescription Patterns and Mortality After Noncardiac Surgery
- 2019
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Ingår i: JAMA Surgery. - : AMER MEDICAL ASSOC. - 2168-6254 .- 2168-6262. ; 154:8
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Tidskriftsartikel (refereegranskat)abstract
- ImportanceThe number of patients prescribed long-term opioids and benzodiazepines and complications from their long-term use have increased. Information regarding the perioperative outcomes of patients prescribed these medications before surgery is limited. ObjectiveTo determine whether patients prescribed opioids and/or benzodiazepines within 6 months preoperatively would have greater short- and long-term mortality and increased opioid consumption postoperatively. Design, Setting, and ParticipantsThis retrospective, single-center, population-based cohort study included all patients 18 years or older, undergoing noncardiac surgical procedures at a national hospital in Iceland from December 12, 2005, to December 31, 2015, with follow-up through May 20, 2016. A propensity score-matched control cohort was generated using individuals from the group that received prescriptions for neither medication class within 6 months preoperatively. Data analysis was performed from April 10, 2018, to March 9, 2019. ExposuresPatients who filled prescriptions for opioids only, benzodiazepines only, both opioids and benzodiazepines, or neither medication within 6 months preoperatively. Main Outcomes and MeasuresLong-term survival compared with propensity score-matched controls. Secondary outcomes were 30-day survival and persistent postoperative opioid consumption, defined as a prescription filled more than 3 months postoperatively. ResultsAmong 41170 noncardiac surgical cases in 27787 individuals (16004 women [57.6%]; mean [SD] age, 56.3 [18.8] years), a preoperative prescription for opioids only was filled for 7460 cases (17.7%), benzodiazepines only for 3121 (7.4%), and both for 2633 (6.2%). Patients who filled preoperative prescriptions for either medication class had a greater comorbidity burden compared with patients receiving neither medication class (Elixhauser comorbidity index >0 for 16% of patients filling prescriptions for opioids only, 22% for benzodiazepines only, and 21% for both medications compared with 14% for patients filling neither). There was no difference in 30-day (opioids only: 1.3% vs 1.0%; P=.23; benzodiazepines only: 1.9% vs 1.5%; P=.32) or long-term (opioids only: hazard ratio [HR], 1.12 [95% CI, 1.01-1.24]; P=.03; benzodiazepines only: HR, 1.11 [95% CI, 0.98-1.26]; P=.11) survival among the patients receiving opioids or benzodiazepines only compared with controls. However, patients prescribed both opioids and benzodiazepines had greater 30-day mortality (3.2% vs 1.8%; P=.004) and a greater hazard of long-term mortality (HR, 1.41; 95% CI, 1.22-1.64; P<.001). The rate of persistent postoperative opioid consumption was higher for patients filling prescriptions for opioids only (43%), benzodiazepines only (23%), or both (66%) compared with patients filling neither (12%) (P<.001 for all). Conclusions and RelevanceThe findings suggest that opioid and benzodiazepine prescription fills in the 6 months before surgery are associated with increased short-and long-term mortality and an increased rate of persistent postoperative opioid consumption. These patients should be considered for early referral to preoperative clinic and medication optimization to improve surgical outcomes.
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| 4. |
- Steingrimsson, Steinn, et al.
(författare)
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Negative-pressure wound therapy for deep sternal wound infections reduces the rate of surgical interventions for early re-infections
- 2012
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Ingår i: Interactive Cardiovascular and Thoracic Surgery. - : Oxford University Press (OUP). - 1569-9285 .- 1569-9293. ; 15:3, s. 406-410
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To evaluate the outcome of treatment for deep sternal wound infection (DSWI) in a nationwide patient cohort, before and after the introduction of negative-pressure wound therapy (NPWT). METHODS: This was a population-based cohort of all patients treated for DSWI in Iceland out of 2446 open heart operations performed between 2000 and 2010. Length of hospital stay, survival and reoperations were compared in (i) 23 patients treated with open and/or closed irrigation before August 2005 (conventional treatment, CvT group) and in (ii) 20 patients treated after this time with NPWT as a first-line therapy (NPWT group). RESULTS: The DSWI rate was 1.8% and did not change during the study period. Demographics were similar for both groups, except for peripheral arterial disease which was less common in the NPWT group. Coagulase-negative staphylococci were also more common (as the only pathogen identified) in the NPWT group (70% vs 30%, P = 0.01). The median length of hospital stay was 43 days in both groups and the sternum could be closed with delayed primary closure in all except 2 patients, one in each group. Eight patients in the CvT group required surgical revision for re-infections, including debridement and rewiring, when compared with 1 patient in the NPWT group (P = 0.02). Furthermore, 6 patients in the CvT group developed late chronic infections of the sternum requiring surgical revision, compared with one in the NPWT group (P = 0.10). The 30-day mortality was not significantly different between groups (4% vs 0%, P > 0.1) and the same was true for 1-year mortality (17% vs 0%, P = 0.11). CONCLUSIONS: NPWT significantly reduces the risk of early re-infections in patients with DSWI. There was a lower rate of late chronic sternal infections and lower mortality in the NPWT group, but the difference was not statistically significant. We conclude that NPWT should be considered as a first-line treatment for most DSWIs.
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