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1.
JTCVS Open ; 3: 91-101, 2020 Sep.
Article in English | MEDLINE | ID: mdl-36003865

ABSTRACT

Objective: It remains unclear how often coronary revascularization is necessary after aortic valve interventions, either by surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement. However, these data are relevant for treatment and prosthesis choice. The authors sought to analyze the incidence and characteristics of coronary revascularization after SAVR during follow-up. Methods: Of 2256 patients undergoing isolated SAVR between 1987 and 2015, 420 patients (mean age 56.9 ± 15.5 years, 66.9% male) were followed at the Erasmus Medical Center. Incidence, predictors, and characteristics of coronary revascularization were analyzed. Cumulative incidence of revascularization was assessed using a competing risk approach. Results: Mean follow-up after SAVR was 17.2 years (total of 4541 patient-years). A total of 24 patients underwent 28 procedures of revascularization. The cumulative incidence of revascularization after SAVR was 0.5%, 2.2%, 4.1%, and 6.9% at 1, 5, 10, and 20 years, respectively. The linearized rate of revascularization was 6.2 per 1000 patient-years. Percutaneous coronary intervention was the most common revascularization method (64%; N = 18/28). Revascularization before SAVR (N = 36/420; of whom 27 percutaneous coronary intervention) was an independent predictor of revascularization during follow-up (hazard ratio, 6.6; 95% confidence interval, 2.6-17.1; P < .001). Conclusions: After SAVR, the rate of coronary revascularization was 6.9% (N = 24/420) at 20-year follow-up. Patients were at particular risk if they had undergone previous revascularization before SAVR. These data may furthermore be relevant to the transcatheter aortic valve replacement population.

2.
Circulation ; 140(16): 1296-1305, 2019 Oct 15.
Article in English | MEDLINE | ID: mdl-31476897

ABSTRACT

BACKGROUND: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. METHODS: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. RESULTS: Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P<0.01) and were more likely to be male (65.1% versus 54.2%; P<0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1-22.9 versus 14.0%; 95% CI, 9.2-21.1; P=0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5-14.7 versus 12.3%; 95% CI, 9.8-15.4; P=0.76). CONCLUSIONS: For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT01586910.

3.
N Engl J Med ; 380(5): 489-491, 2019 01 31.
Article in English | MEDLINE | ID: mdl-30699308
4.
J Am Coll Cardiol ; 71(24): 2756-2769, 2018 06 19.
Article in English | MEDLINE | ID: mdl-29802016

ABSTRACT

BACKGROUND: The functional SYNTAX score (FSS) has been shown to improve the discrimination for major adverse cardiac events compared with the anatomic SYNTAX score (SS) while reducing interobserver variability. However, evidence supporting the noninvasive FSS in patients with multivessel coronary artery disease (CAD) is scarce. OBJECTIVES: The purpose of this study was to assess the feasibility of and validate the noninvasive FSS derived from coronary computed tomography angiography (CTA) with fractional flow reserve (FFRCT) in patients with 3-vessel CAD. METHODS: The CTA-SS was calculated in patients with 3-vessel CAD included in the SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study. The noninvasive FSS was determined by including only ischemia-producing lesions (FFRCT ≤0.80). SS derived from different imaging modalities were compared using the Bland-Altman and Passing-Bablok method, and the agreement on the SS tertiles was investigated with Cohen's Kappa. The risk reclassification was compared between the noninvasive and invasive physiological assessment, and the diagnostic accuracy of FFRCT was assessed by the area under the receiver-operating characteristic curve using instantaneous wave-free ratio as a reference. RESULTS: The CTA-SS was feasible in 86% of patients (66 of 77), whereas the noninvasive FSS was feasible in 80% (53 of 66). The anatomic SS was overestimated by CTA compared with conventional angiography (27.6 ± 6.4 vs. 25.3 ± 6.9; p < 0.0001) whereas the calculation of the FSS yielded similar results between the noninvasive and invasive imaging modalities (21.6 ± 7.8 vs. 21.2 ± 8.8; p = 0.589). The noninvasive FSS reclassified 30% of patients from the high- and intermediate-SS tertiles to the low-risk tertile, whereas invasive FSS reclassified 23% of patients from the high- and intermediate-SS tertiles to the low-risk tertile. The agreement on the classic SS tertiles based on Kappa statistics was slight for the anatomic SS (Kappa = 0.19) and fair for the FSS (Kappa = 0.32). The diagnostic accuracy of FFRCT to detect functional significant stenosis based on an instantaneous wave-free ratio ≤0.89 revealed an area under the receiver-operating characteristics curve of 0.85 (95% CI: 0.79 to 0.90) with a sensitivity of 95% (95% CI: 89% to 98%), specificity of 61% (95% CI: 48% to 73%), positive predictive value of 81% (95% CI: 76% to 86%), and negative predictive value of 87% (95% CI: 74% to 94%). CONCLUSIONS: Calculation of the noninvasive FSS is feasible and yielded similar results to those obtained with invasive pressure-wire assessment. The agreement on the SYNTAX score tertile classification improved with the inclusion of the functional component from slight to fair agreement. FFRCT has good accuracy in detecting functionally significant lesions in patients with 3-vessel CAD. (A Trial to Evaluate a New Strategy in the Functional Assessment of 3-Vessel Disease Using SYNTAX II Score in Patients Treated With PCI; NCT02015832).


Subject(s)
Computed Tomography Angiography , Coronary Artery Disease/diagnostic imaging , Fractional Flow Reserve, Myocardial , Aged , Coronary Artery Disease/physiopathology , Feasibility Studies , Female , Humans , Male , Middle Aged
5.
Eur Heart J ; 39(19): 1687-1697, 2018 05 14.
Article in English | MEDLINE | ID: mdl-28171522

ABSTRACT

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.


Subject(s)
Cardiovascular Surgical Procedures/adverse effects , Clinical Trials as Topic , Nervous System Diseases/diagnosis , Nervous System Diseases/etiology , Catheterization/adverse effects , Endpoint Determination , Humans , Nervous System Diseases/classification , Neurologic Examination , Postoperative Complications , Risk Assessment
6.
N Engl J Med ; 376(14): 1321-1331, 2017 04 06.
Article in English | MEDLINE | ID: mdl-28304219

ABSTRACT

BACKGROUND: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).


Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Bayes Theorem , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Postoperative Complications , Risk Factors , Severity of Illness Index , Stroke/epidemiology , Transcatheter Aortic Valve Replacement/adverse effects
7.
J Am Coll Cardiol ; 69(6): 679-691, 2017 Feb 14.
Article in English | MEDLINE | ID: mdl-28183511

ABSTRACT

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.


Subject(s)
Cardiovascular Diseases/therapy , Endpoint Determination/standards , Cardiovascular Diseases/complications , Cardiovascular Diseases/diagnosis , Clinical Trials as Topic , Humans , Nervous System Diseases/diagnosis , Research Design
9.
Interact Cardiovasc Thorac Surg ; 20(5): 601-4, 2015 May.
Article in English | MEDLINE | ID: mdl-25662958

ABSTRACT

OBJECTIVES: A 3-year follow-up of a retrospective, single-centre clinical study of OPCAB (off-pump coronary artery bypass) no-touch technique with arterial composite grafts and an indirect comparison with clinical outcomes of the 3-year follow-up of the SYNTAX trial. METHODS: A total of 400 consecutive patients ('all-comers') who underwent OPCAB no-touch coronary surgery. Primary endpoint was 3-year MACCE (major adverse cardiovascular and cerebrovascular events). These results were compared with the randomized arms of the SYNTAX trial. RESULTS: The observed 3-year survival was 82.2%. The cumulative 3-year freedom from MACCE was 89.7%. The percentage of MACCE was significantly lower (P < 0.001) in the OPCAB no-touch group (10.3%) compared with both arms of the SYNTAX trial (20.2 and 28.0%, respectively). Repeat revascularization in the OPCAB no-touch group (4.3%) was significantly lower (P < 0.001) compared with both arms of the SYNTAX trial (10.7 and 19.7%, respectively). The percentage of stroke was significantly lower (P = 0.032) in the OPCAB no-touch group compared with the CABG arm in the SYNTAX trial (1.3 vs 3.4%). There was no significant difference of stroke rate between the OPCAB no-touch group and the PCI arm of the SYNTAX trial (1.3 vs 2%, P = 0.347). CONCLUSIONS: The results at the 3-year follow-up showed the safety and efficacy of OPCAB no-touch technique. The OPCAB no-touch technique may improve patients' outcome by minimizing the morbidity and the neurological complications. Prospective controlled trials are needed to confirm these results.


Subject(s)
Cause of Death , Coronary Artery Bypass, Off-Pump/mortality , Coronary Stenosis/mortality , Coronary Stenosis/surgery , Hospital Mortality/trends , Aged , Coronary Angiography/methods , Coronary Artery Bypass, Off-Pump/methods , Coronary Stenosis/diagnostic imaging , Disease-Free Survival , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Netherlands , Postoperative Complications/mortality , Postoperative Complications/physiopathology , Risk Assessment , Severity of Illness Index , Stroke/etiology , Stroke/mortality , Survival Rate , Time Factors , Touch
10.
Interact Cardiovasc Thorac Surg ; 19(5): 777-81, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25074233

ABSTRACT

OBJECTIVES: The transaortic (TAo) approach has been introduced as an alternative to transapical and transaxillary aortic valve implantation for patients with symptomatic severe aortic stenosis in whom a transfemoral approach is not feasible. However, only very limited data from a minimal number of specialized centres are available on this approach. Therefore, the aim of this study was to evaluate the early postoperative 30-day outcomes of the direct aortic approach performed by a single-centre multidisciplinary Heart Team. METHODS: Between May 2011 and July 2013, 159 patients underwent transcatheter aortic valve implantation (TAVI) at our institution; of which, 44 were believed to benefit most from the TAo as assessed by a multidisciplinary Heart Team. All patients underwent an upper 'J' median hemi-sternotomy through a 6-cm incision. The evaluation of early operative results was made according to the Valve Academic Research Consortium (VARC) consensus criteria. These include device success endpoints and combined safety endpoints at 30 days. RESULTS: The mean age of the patients was 78 years, the mean logistic EuroSCORE was 25.9 ± 14.4% and the mean Society of the Thoracic Surgeons score 5.8 ± 4.5%. Seventeen patients (39%) underwent redo operations; 4 (9%) received a transcatheter valve in a degenerated bioprosthesis. The procedure was performed using the Medtronic CoreValve Revalving system in 36 patients, with the Edwards SAPIEN XT in 7 cases and the St Jude Medical Portico valve in 1. Device success was achieved in 90.8% of the cases. Complications included; major stroke (n = 1), re-exploration for cardiac tamponade (n = 3), transient renal failure requiring temporary haemodialysis (n = 1) and permanent pacemaker implantation (n = 5). There were no myocardial infarctions. The total 30-day mortality rate was 6.8% (3 patients). Postoperative intensive care unit stay was 2.6 ± 3.6 days, and the mean hospitalization was 12 ± 9.6 days. CONCLUSIONS: The TAo TAVI approach is feasible and offers a safe alternative for patients in whom a transfemoral approach is not feasible or desirable.


Subject(s)
Aortic Valve Stenosis/surgery , Bioprosthesis , Heart Valve Prosthesis , Patient Care Team , Transcatheter Aortic Valve Replacement/methods , Aged , Aorta, Thoracic , Aortic Valve Stenosis/diagnosis , Echocardiography , Female , Follow-Up Studies , Humans , Length of Stay/trends , Male , Prosthesis Design , Retrospective Studies , Tomography, X-Ray Computed , Treatment Outcome
11.
Eur Heart J ; 35(38): 2639-54, 2014 Oct 07.
Article in English | MEDLINE | ID: mdl-25062953

ABSTRACT

This article provides an overview on procedure-related issues and uncertainties in outcomes after transcatheter aortic valve implantation (TAVI). The different access sites and how to select them in an individual patient are discussed. Also, the occurrence and potential predictors of aortic regurgitation (AR) after TAVI are addressed. The different methods to quantify AR are reviewed, and it appears that accurate and reproducible quantification is suboptimal. Complications such as prosthesis-patient mismatch and conduction abnormalities (and need for permanent pacemaker) are discussed, as well as cerebrovascular events, which emphasize the development of optimal anti-coagulative strategies. Finally, recent registries have shown the adoption of TAVI in the real world, but longer follow-up studies are needed to evaluate the outcome (but also prosthesis durability). Additionally, future studies are briefly discussed, which will address the use of TAVI in pure AR and lower-risk patients.


Subject(s)
Aortic Valve Stenosis/surgery , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/prevention & control , Arrhythmias, Cardiac/etiology , Arrhythmias, Cardiac/therapy , Bioprosthesis , Cardiac Imaging Techniques , Fibrinolytic Agents/therapeutic use , Forecasting , Humans , Pacemaker, Artificial , Patient Selection , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Prognosis , Prosthesis Failure , Stroke/etiology , Stroke/prevention & control , Treatment Outcome
12.
Eur Heart J ; 35(38): 2627-38, 2014 Oct 07.
Article in English | MEDLINE | ID: mdl-25062952

ABSTRACT

An exponential increase in the use of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis has been witnessed over the recent years. The current article reviews different areas of uncertainty related to patient selection. The use and limitations of risk scores are addressed, followed by an extensive discussion on the value of three-dimensional imaging for prosthesis sizing and the assessment of complex valve anatomy such as degenerated bicuspid valves. The uncertainty about valvular stenosis severity in patients with a mismatch between the transvalvular gradient and the aortic valve area, and how integrated use of echocardiography and computed tomographic imaging may help, is also addressed. Finally, patients referred for TAVI may have concomitant mitral regurgitation and/or coronary artery disease and the management of these patients is discussed.


Subject(s)
Aortic Valve Stenosis/surgery , Patient Selection , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnosis , Cardiac Imaging Techniques , Coronary Artery Disease/complications , Heart Valve Prosthesis , Humans , Mitral Valve Insufficiency/complications , Mitral Valve Insufficiency/surgery , Prosthesis Design , Risk Assessment , Treatment Outcome , Vascular Calcification/diagnosis , Ventricular Dysfunction, Left/etiology
13.
N Engl J Med ; 369(13): 1206-14, 2013 Sep 26.
Article in English | MEDLINE | ID: mdl-23991661

ABSTRACT

BACKGROUND: Dabigatran is an oral direct thrombin inhibitor that has been shown to be an effective alternative to warfarin in patients with atrial fibrillation. We evaluated the use of dabigatran in patients with mechanical heart valves. METHODS: In this phase 2 dose-validation study, we studied two populations of patients: those who had undergone aortic- or mitral-valve replacement within the past 7 days and those who had undergone such replacement at least 3 months earlier. Patients were randomly assigned in a 2:1 ratio to receive either dabigatran or warfarin. The selection of the initial dabigatran dose (150, 220, or 300 mg twice daily) was based on kidney function. Doses were adjusted to obtain a trough plasma level of at least 50 ng per milliliter. The warfarin dose was adjusted to obtain an international normalized ratio of 2 to 3 or 2.5 to 3.5 on the basis of thromboembolic risk. The primary end point was the trough plasma level of dabigatran. RESULTS: The trial was terminated prematurely after the enrollment of 252 patients because of an excess of thromboembolic and bleeding events among patients in the dabigatran group. In the as-treated analysis, dose adjustment or discontinuation of dabigatran was required in 52 of 162 patients (32%). Ischemic or unspecified stroke occurred in 9 patients (5%) in the dabigatran group and in no patients in the warfarin group; major bleeding occurred in 7 patients (4%) and 2 patients (2%), respectively. All patients with major bleeding had pericardial bleeding. CONCLUSIONS: The use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefit and an excess risk. (Funded by Boehringer Ingelheim; ClinicalTrials.gov numbers, NCT01452347 and NCT01505881.).


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Benzimidazoles/administration & dosage , Heart Valve Prosthesis , Stroke/prevention & control , Thromboembolism/prevention & control , Warfarin/administration & dosage , beta-Alanine/analogs & derivatives , Aged , Anticoagulants/adverse effects , Benzimidazoles/adverse effects , Dabigatran , Female , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Thromboembolism/chemically induced , Warfarin/adverse effects , beta-Alanine/administration & dosage , beta-Alanine/adverse effects
14.
Eur J Cardiothorac Surg ; 44(4): 605-14, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23371972

ABSTRACT

Clinical registries will have an increasingly important role to play in health-care, with a number already established in cardiac surgery. This review covers the fundamentals of establishing and managing clinical registries, including legal and ethical frameworks along with intellectual property attribution. Also discussed are important issues relating to the processing of data, data extraction and conducting analyses using registry data.


Subject(s)
Intellectual Property , Registries , Biomedical Research , Ethics, Professional , Humans , Management Information Systems
15.
Cardiol Rev ; 20(6): 279-87, 2012.
Article in English | MEDLINE | ID: mdl-22858831

ABSTRACT

Remote ischemic conditioning (RIC) is an intervention, in which intermittent episodes of ischemia and reperfusion in an organ or tissue distant from the target organ requiring protection, provide armour against lethal ischemia-reperfusion injury. Although the exact mechanisms underlying the protection mediated through RIC have not been clearly established, the release of humoral factors and the activation of neural pathways have been implicated. There is now clinical evidence suggesting that this form of protection can be induced by a simple, noninvasive, and cost-effective procedure such as inflation and deflation of a blood pressure cuff and that this intervention provides increased organ protection in a variety of clinical scenarios, for example, in myocardial infarction. Here we provide an overview of the history and evolution of RIC, the potential mechanisms underlying its protective effects, and published randomized clinical trials in cardiovascular procedures.


Subject(s)
Coronary Artery Bypass/adverse effects , Ischemic Preconditioning, Myocardial/adverse effects , Myocardial Infarction/prevention & control , Myocardial Reperfusion Injury/complications , Humans , Ischemic Preconditioning, Myocardial/methods , Myocardial Infarction/etiology , Myocardial Reperfusion Injury/prevention & control , Time Factors
16.
Circ J ; 76(10): 2392-404, 2012.
Article in English | MEDLINE | ID: mdl-22785338

ABSTRACT

BACKGROUND: Although remote ischemic conditioning (RIC) by transient limb ischemia in percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) has shown favorable effects on myocardial (ischemia-reperfusion) injury, recent trials provide inconsistent results. The aim of the present study was to assess the effect of RIC in PCI or CABG. METHODS AND RESULTS: Medline/Embase/conference reports were searched for randomized RIC trials and were included if they reported on biomarkers of myocardial injury (CK-MB/troponin T/I), after which, standardized mean differences (SMDs) were calculated (Hedges g statistic). Meta-analysis of 4 studies on PCI, involving 557 patients, indicated reduced biomarkers for myocardial injury with RIC compared to control (random effects model: SMD, -0.21; 95% confidence interval [CI]: -0.66 to 0.24). Analysis of primary PCI studies, involving 314 patients, indicated a highly significant positive effect of RIC on myocardial injury (SMD, -0.55; 95% CI: -0.77 to -0.32). The 13 CABG studies taken together, involving 891 patients, indicated a significant effect of RIC on myocardial injury (SMD, -0.34; 95% CI: -0.59 to -0.08). The statistical tests indicated moderate to high heterogeneity across the studies (Q-statistic: PCI, P=0.0006, I(2)=83%; CABG, P<0.0001, I(2)=69%). CONCLUSIONS: In patients undergoing PCI or CABG, RIC with transient episodes of limb ischemia is associated with lower biomarkers of myocardial injury compared to control, but this effect failed to reach statistical significance in the overall PCI analysis.


Subject(s)
Ischemic Preconditioning, Myocardial/methods , Percutaneous Coronary Intervention/methods , Reperfusion Injury/prevention & control , Biomarkers/blood , Coronary Artery Bypass , Female , Humans , MEDLINE , Male , Randomized Controlled Trials as Topic , Reperfusion Injury/blood
17.
Interact Cardiovasc Thorac Surg ; 9(2): 227-31, 2009 Aug.
Article in English | MEDLINE | ID: mdl-19447793

ABSTRACT

The aim of this study was to evaluate short- and long-term outcome in patients undergoing coronary artery bypass grafting (CABG), who received an intra-aortic balloon pump (IABP) prior to surgery. Between January 1990 and June 2004, all patients (n=154) who received an IABP prior to on-pump CABG in our center were included. Patients received the IABP for vital indications (i.e. either unstable angina refractory to medical therapy or cardiogenic shock; group 1: n=99) or for prophylactic reasons (group 2: n=55). A Cox proportional hazards model was used to identify predictors of long-term all-cause mortality. Compared with the EuroSCORE predictive model, observed 30-day mortality in group 1 (15.2%) was slightly higher than predicted (10.3%). A decrease in 30-day mortality occurred in group 2 (median predicted mortality was 7.2% and observed was 0%). Cumulative 1-, 5-, and 6-year survival was 82.8+/-3.8%, 70.1+/-4.9%, and 67.3+/-5.1% for group 1 vs. 98.2+/-1.8%, 84.0+/-5.6% and 84.0+/-5.6% for group 2 (Log-rank: P=0.02). Logistic EuroSCORE (HR 1.03 [1.01-1.05], P=0.007) was an independent predictor of long-term all-cause mortality.


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease/surgery , Intra-Aortic Balloon Pumping , Aged , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Coronary Artery Disease/mortality , Female , Follow-Up Studies , Humans , Intra-Aortic Balloon Pumping/adverse effects , Intra-Aortic Balloon Pumping/mortality , Kaplan-Meier Estimate , Male , Middle Aged , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment Outcome
18.
Catheter Cardiovasc Interv ; 74(2): 302-10, 2009 Aug 01.
Article in English | MEDLINE | ID: mdl-19360865

ABSTRACT

OBJECTIVES: In a single center experience, we retrospectively evaluated the short-term safety and efficacy of the TandemHeart percutaneous transseptal left ventricular assist (PTVA) system to deliver extracorporeal circulatory support during catheter based treatment of the unprotected left main coronary artery (ULMCA). BACKGROUND: Percutaneous Coronary Intervention (PCI) of the ULMCA usually has been restricted to patients who are hemodynamically unstable or ineligible for coronary artery bypass grafting (CABG). High-risk patients for CABG should be considered at increased risk for PCI as well. In these patients the TandemHeart PTVA System (p-LVAD) may provide a valuable safeguard to reduce procedural risks. METHODS AND RESULTS: Between July 2002 and May 2008 the TandemHeart was used in 9 very high risk patients (Logistic Euro score: 13.64 (7.46-29.67); Syntax score:43 (41-50); Mayo Clinic Risk score (MCRS) 7 (6-8); age: median 65 (range 55-71) undergoing elective PCI for the novo lesions on the ULMCA. All patients were declined for CABG by a heart team. A ''true'' percutaneous insertion technique was used in all patients, technical success rate was 100%. The median (range) time for implementation of circulatory support was 27 min (24-30). A median (range) pump flow up to 4.36 (3.40-5.54) L/min was achieved with significant reduction of left ventricular filling pressures, pulmonary capillary wedge pressure and a small increase of systemic arterial pressures. Median (range) duration of support was 93 min (50.4-102). Successful weaning was achieved in all patients. There was no in hospital death, survival at 6 months was (89%), whereas vascular access site complications were seen in 4 patients (44.4%). CONCLUSIONS: In very high risk PCI, assisted circulation using the TandemHeart-PTVA provides effective, total left ventricular support and may contribute to a reduced procedural risk and improved survival. The rate of device related cardiac and vascular complications was acceptable.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Bypass , Coronary Artery Disease/therapy , Extracorporeal Circulation/instrumentation , Heart-Assist Devices , Patient Selection , Stents , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/instrumentation , Contraindications , Coronary Artery Disease/physiopathology , Extracorporeal Circulation/adverse effects , Female , Heart-Assist Devices/adverse effects , Hemodynamics , Humans , Male , Middle Aged , Patient Care Team , Prosthesis Design , Retrospective Studies , Risk Assessment , Time Factors , Treatment Outcome
20.
Interact Cardiovasc Thorac Surg ; 7(4): 634-7, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18487235

ABSTRACT

The aim of the study was to validate a newly-designed epicardial coronary artery Doppler probe and test its detection of changes in coronary blood flow velocity. Left anterior descending (LAD) coronary blood flow and flow velocity were evaluated in four pigs with a pericoronary transit time flow (TTF) probe and a newly-designed epicardial Doppler micro-probe. Four consecutive measurements were taken for each of the following conditions: basal, partial stenosis, occlusion, and reperfusion of the LAD. Mean TTF value (ml/min) was 23.2+/-6.6 in basal condition, 16.2+/-5.7 after partial LAD stenosis, 0.1+/-0.3 during LAD occlusion, and 67.4+/-23.3 at reperfusion (P<0.001). Similar patterns were recorded in terms of Doppler velocity (cm/s) with values of 4.0+/-1.9 in basal condition, 3.5+/-2.3 after partial LAD stenosis, 0.5+/-1.4 during LAD occlusion, and 11.1+/-5.5 at reperfusion (P<0.001). No significant differences in both TTF and Doppler velocity were detected between basal condition and partial LAD stenosis (P=ns). Epicardial coronary arterial Doppler represents a valuable tool to detect coronary arterial flow velocity in basal condition. Although changes in flow velocity are easily recorded after coronary occlusion and reperfusion, modifications after partial coronary stenosis are not clearly defined.


Subject(s)
Coronary Circulation , Coronary Occlusion/diagnostic imaging , Coronary Stenosis/diagnostic imaging , Coronary Vessels/diagnostic imaging , Echocardiography, Doppler , Laser-Doppler Flowmetry , Animals , Blood Flow Velocity , Coronary Occlusion/physiopathology , Coronary Stenosis/physiopathology , Coronary Vessels/physiopathology , Disease Models, Animal , Echocardiography, Doppler/instrumentation , Equipment Design , Laser-Doppler Flowmetry/instrumentation , Pericardium , Reproducibility of Results , Swine , Time Factors
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