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1.
J Card Surg ; 36(11): 4024-4029, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34365660

ABSTRACT

INTRODUCTION: Limited data are available about the outcomes of transcatheter mitral valve replacement (TMVR) using transseptal approach in patients with prior mitral valve repair (valve-in-ring) or replacement (valve-in-valve) (TMViVR) and on modes of the prior surgical valve failures. We report our tertiary center TMVR experience in high surgical risk patients with prior mitral valve repair or replacement. METHODS: From December 2016 to January 2020, patients with symptomatic severe mitral valve stenosis and/or insufficiency at increased redo surgical risk were included. TMViVR was performed off-label with Sapien S3 valve (Edwards Lifesciences). Patients were followed within 30-days and 1-year from the procedure. RESULTS: Twenty-seven patients underwent transcatheter mitral valve-in-valve (n = 21) or valve-in-ring (n = 6) replacement. Mean ± SD age was 71.8 ± 11 years with Society of Thoracic Surgeons' calculated mortality 7.1 ± 4.6%. The etiology of valve failure was stenosis in 17 (63%) patients, insufficiency in 4 (14.8%) patients, and both in 6 (22.2%) patients. TMViVR technical success was 100% in all patients. Left ventricular outflow track (LVOT) obstruction was observed in only one (3.7%) patient. Zero patients had moderate or severe central mitral valve regurgitation or paravalvular leak. All patients had symptomatic improvement at 30 days. The mean transmitral diastolic pressure gradient decreased from 14.1 ± 4.6 to 6.9 ± 4.6 mm Hg (p < .001) at 30 days. The one patient with LOVT obstruction required readmission at 5-months. One-year survival was 95%. At 1-year mean gradients remained lower than the baseline (7.0 ± 3.0 vs. 12.4 ± 4.0, p = .002). CONCLUSIONS: Transcatheter mitral valve-in-valve and valve-in-ring replacement is feasible and safe. The improvement in mitral valve hemodynamics appears to be durable.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Insufficiency , Aged , Aged, 80 and over , Cardiac Catheterization , Humans , Middle Aged , Mitral Valve/surgery , Mitral Valve Insufficiency/surgery , Risk Factors , Surgical Instruments , Treatment Outcome
2.
Eur Heart J ; 40(7): 607-617, 2019 02 14.
Article in English | MEDLINE | ID: mdl-30561620

ABSTRACT

AIMS: The role of aspirin in the primary prevention setting is continuously evolving. Recent randomized trials have challenged the role of aspirin in the primary prevention setting. METHODS AND RESULTS: Electronic databases were searched for randomized trials that compared aspirin vs. placebo (or control) in subjects without established atherosclerotic disease. The primary efficacy outcome was all-cause mortality, while the primary safety outcome was major bleeding. Summary estimates were reported using a DerSimonian and Laird random effects model. A total of 11 trials with 157 248 subjects were included. At a mean follow-up of 6.6 years, aspirin was not associated with a lower incidence of all-cause mortality [risk ratio (RR) 0.98, 95% confidence interval (CI) 0.93-1.02; P = 0.30]; however, aspirin was associated with an increased incidence of major bleeding (RR 1.47, 95% CI 1.31-1.65; P < 0.0001) and intracranial haemorrhage (RR 1.33, 95% CI 1.13-1.58; P = 0.001). A similar effect on all-cause mortality and major bleeding was demonstrated in diabetic and high cardiovascular risk patients (i.e. 10-year risk >7.5%). Aspirin was associated with a lower incidence of myocardial infarction (RR 0.82, 95% CI 0.71-0.94; P = 0.006); however, this outcome was characterized by considerable heterogeneity (I2 = 67%), and this effect was no longer evident upon limiting the analysis to the more recent trials. Trial sequential analysis confirmed the lack of benefit of aspirin for all-cause mortality up to a relative risk reduction of 5%. CONCLUSION: Among adults without established cardiovascular disease, aspirin was not associated with a reduction in the incidence of all-cause mortality; however, it was associated with an increased incidence of major bleeding. The routine use of aspirin for primary prevention needs to be reconsidered.


Subject(s)
Aspirin/therapeutic use , Cardiovascular Diseases/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Humans , Randomized Controlled Trials as Topic
3.
Lancet ; 391(10134): 1997-2007, 2018 05 19.
Article in English | MEDLINE | ID: mdl-29759512

ABSTRACT

BACKGROUND: Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. METHODS: Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. FINDINGS: Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. INTERPRETATION: In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy. FUNDING: US Department of Veterans Affairs Cooperative Studies Program.


Subject(s)
Graft Rejection/drug therapy , Percutaneous Coronary Intervention/instrumentation , Saphenous Vein/surgery , Thrombosis/epidemiology , Aged , Double-Blind Method , Drug-Eluting Stents , Female , Humans , Male , Middle Aged , Self Expandable Metallic Stents , Thrombosis/etiology , Treatment Outcome
4.
J Card Surg ; 33(9): 489-496, 2018 Sep.
Article in English | MEDLINE | ID: mdl-30058259

ABSTRACT

BACKGROUND: Bicuspid aortic valve (BAV) stenosis has been considered a relative contraindication to transcatheter aortic valve replacement (TAVR). We compared the outcomes of TAVR in patients with BAV stenosis versus patients with trileaflet aortic valve stenosis. METHODS: From March 2012 to September 2017, 727 patients underwent TAVR. Thirty-two patients with BAV were included in this study and compared to 96 patients with comparable risk factors (1:3) with a trileaflet aortic valve (TAV). Transesophageal echocardiography was used to estimate post-TAVR degree of paravalvular leak (PVL). RESULTS: Mean ± standard deviation Society of Thoracic Surgeons risk was 6.01 ± 3.42 in the BAV group and 6.08 ± 3.76 in the TAV group (P = 0.92). Thirty-day mortality was 4.2% (N = 4) in the TAV group and 6.25% (N = 2) in the BAV group (P = 0.63). Three (3.1%) patients in the TAV group and two (6.25%) patients in the BAV group developed a post operative stroke (P = 0.59). Following TAVR, mean aortic valve gradient significantly decreased in both TAV (42.56 ± 14.93 vs 9.27 ± 5.57, P < 0.001) and BAV (44.12 ± 11.82 vs 9.03 ± 7.29, P < 0.001) groups. No patient had a severe PVL after TAVR, and only two (2.08%) patients in the TAV group and one (3.12%) patient in the BAV group had moderate PVL (P = 1.0). Patient survival rate at 1 and 2 years was 86% in the BAV group and 90% at 1 and 2 years in the TAV group (P = 0.74). CONCLUSIONS: TAVR in BAV disease is feasible with favorable valve performance. Immediate and mid-term outcomes of TAVR in patients with BAV are comparable to those with TAV.


Subject(s)
Aortic Valve Stenosis/surgery , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Echocardiography, Transesophageal , Feasibility Studies , Female , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Risk , Stroke/epidemiology , Survival Rate
7.
Dig Dis Sci ; 62(1): 26-34, 2017 01.
Article in English | MEDLINE | ID: mdl-27830409

ABSTRACT

Patients with advanced liver disease have a high prevalence of cardiovascular risk factors, but many of them are asymptomatic. Cardiovascular risk stratification prior to liver transplant can be done by dobutamine stress echocardiography, stress myocardial perfusion imaging, cardiac computer tomography, and coronary angiography, but there are no clear recommendations regarding what method should be used and who should be screened. Because of this and because of inherent risk profile in this population, the variations in practice are significant. Careful screening and rigorous management of cardiovascular risk factors are important to ensure optimal cardiovascular outcomes in the immediate post-transplantation period and in the long term as well.


Subject(s)
Cardiovascular Diseases/diagnostic imaging , Coronary Vessels/diagnostic imaging , End Stage Liver Disease/surgery , Heart/diagnostic imaging , Liver Transplantation , Perioperative Care/methods , Cardiovascular Diseases/complications , Cardiovascular Diseases/diagnosis , Coronary Angiography , Echocardiography, Stress , End Stage Liver Disease/complications , Humans , Mass Screening , Myocardial Perfusion Imaging , Risk Assessment , Tomography, Emission-Computed, Single-Photon , Tomography, X-Ray Computed
8.
Curr Cardiol Rep ; 19(1): 8, 2017 01.
Article in English | MEDLINE | ID: mdl-28138824

ABSTRACT

PURPOSE OF REVIEW: Nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most widely used medications worldwide. There has been growing concern regarding the cardiovascular risks associated with NSAID use (both selective cyclooxygenase [COX]-2 inhibitors and nonselective NSAIDs). This review will examine the evidence pertaining to cardiovascular safety and bleeding risk related to nonaspirin NSAIDs. RECENT FINDINGS: Earlier studies exposed the cardiovascular risks associated with use of selective COX-2 inhibitors; however, further studies have shown that even nonselective COX inhibition may lead to an increased risk of cardiovascular events. Data have also suggested that nonaspirin NSAIDs carry a higher bleeding risk in patients on antithrombotic therapy. Nonaspirin NSAIDs may confer an increased risk of both adverse cardiovascular outcomes and bleeding complications, regardless of COX selectivity and duration of use. Thus, it remains important to limit their use whenever possible, especially in patients with established cardiovascular disease.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Cardiovascular Diseases/drug therapy , Cyclooxygenase 2 Inhibitors/adverse effects , Hemorrhage/chemically induced , Humans , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors
10.
Catheter Cardiovasc Interv ; 88(4): 501-505, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26524970

ABSTRACT

OBJECTIVES: To perform an updated meta-analysis to determine whether complete revascularization of significant coronary lesions at the time of primary percutaneous coronary intervention (PCI) would be associated with better outcomes compared with culprit-only revascularization. BACKGROUND: Individual trials have demonstrated conflicting evidence regarding the optimum revascularization strategy at the time of primary PCI. METHODS: Clinical trials that randomized ST elevation myocardial infarction (STEMI) patients with multi-vessel disease to a complete versus culprit-only revascularization strategy were included. Random effects summary risk ratios (RR) were constructed using a DerSimonian-Laird model. The primary outcome of interest was mortality or myocardial infarction (MI). RESULTS: A total of seven trials with 1,939 patients were included in the analysis. Compared with culprit-only revascularization, complete revascularization was associated with a non-significant reduction in the risk of mortality or MI (RR 0.69, 95% confidence interval (CI) 0.42-1.12, P = 0.14). Complete revascularization was associated with a reduced risk of major adverse cardiac events (MACE) (RR 0.61, 95% CI 0.45-0.81, P < 0.001), due to a significant reduction in urgent revascularization (RR 0.46, 95% CI 0.29-0.70, P < 0.001). The risk of major bleeding and contrast-induced nephropathy was similar with both approaches (RR 0.83, 95% CI 0.41-1.71, P = 0.62, and RR 0.94, 95% CI 0.42-2.12, P = 0.82). CONCLUSIONS: Complete revascularization of all significant coronary lesions at the time of primary PCI was associated with a reduction in the risk of MACE due to reduction in the risk of urgent revascularization. This approach appears to be safe, with no excess major bleeding, or contrast-induced nephropathy. © 2015 Wiley Periodicals, Inc.


Subject(s)
Coronary Artery Disease/therapy , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/therapy , Aged , Contrast Media/adverse effects , Coronary Angiography/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Female , Hemorrhage/etiology , Humans , Kidney Diseases/chemically induced , Male , Middle Aged , Odds Ratio , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Randomized Controlled Trials as Topic , Recurrence , Risk Assessment , Risk Factors , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/mortality , Time Factors , Treatment Outcome
11.
Catheter Cardiovasc Interv ; 88(5): 765-774, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27515910

ABSTRACT

OBJECTIVES: To perform an updated systematic review comparing a routine invasive strategy with a selective invasive strategy for patients with non-ST-elevation acute coronary syndromes (NSTE-ACS) in the era of stents and antiplatelet therapy. BACKGROUND: Recent meta-analyses comparing both strategies have shown conflicting results. METHODS: Electronic databases were searched for randomized trials that compared a routine invasive strategy (i.e., routine coronary angiography +/- revascularization) versus a selective invasive strategy (i.e., medical stabilization and coronary angiography +/- revascularization if objective evidence of ischemia or refractory ischemia) in patients with NSTE-ACS. Summary odds ratios (OR) were primarily constructed using Peto's model. RESULTS: Twelve trials with 9,650 patients were included. Compared with a selective invasive strategy, a routine invasive strategy was associated with a reduction in the composite of all-cause mortality or myocardial infarction (MI) [OR: 0.86, 95% confidence interval (CI) 0.77-0.96] at a mean follow-up of 39 months, primarily due to a reduction in the risk of MI (OR: 0.78, 95% CI: 0.68-0.88). The risk of all-cause mortality was non-significantly reduced with a routine invasive strategy (OR: 0.88, 95% CI: 0.77-1.01). The risk of recurrent angina was reduced with a routine invasive strategy (OR: 0.55, 95% CI: 0.49-0.62), as well as the risk of future revascularization procedures (OR: 0.35, 95% CI: 0.30-0.39). CONCLUSION: In patients with NSTE-ACS, a routine invasive strategy reduced the risk of ischemic events, including the risk of mortality or MI. Routine invasive therapy reduced the risk of recurrent angina and future revascularization procedures. © 2016 Wiley Periodicals, Inc.


Subject(s)
Acute Coronary Syndrome/surgery , Non-ST Elevated Myocardial Infarction/etiology , Randomized Controlled Trials as Topic , Acute Coronary Syndrome/complications , Acute Coronary Syndrome/diagnosis , Coronary Angiography , Humans , Myocardial Revascularization , Non-ST Elevated Myocardial Infarction/diagnosis , Non-ST Elevated Myocardial Infarction/surgery
12.
J Card Surg ; 31(7): 416-22, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27212701

ABSTRACT

BACKGROUND: Acute kidney injury (AKI) during transcatheter aortic valve replacement (TAVR) increases morbidity and mortality. In this study, we investigated the incidence and risk factors for AKI in patients undergoing TAVR. METHODS: Two hundred ninety consecutive patients underwent TAVR. Valve Academic Research Consortium (VARC)-I criteria for AKI diagnosis at 72 hours, and VARC-II criteria at seven days were employed. RESULTS: Overall AKI incidence was 24.62% (65/264): 50 patients at 72 hours and 15 patients at seven days. Multivariate logistic regression determined transapical (TA) approach (OR: 4.46 [1.37-7.63]), preprocedural glomerular filtration rate less than 45 mL/min (OR: 3.47 [1.35-14.70]), and blood transfusion (OR: 3.34 [1.58-11.09]) as independent predictors for AKI at 72 hours; and prior coronary artery bypass grafting (OR: 3.02 [1.007-9.09]) and peripheral artery disease (PAD) (OR: 3.53 [1.06-11.62]) for AKI at seven days. In-hospital and 30-day mortality was higher in AKI patients. Non-AKI patients' survival was 93% at six months, 89% at 12 months, and 86% at 24 months, whereas survival in AKI at 72 hours was 66% at 6, 12, and 24 months (HR AKI vs. non-AKI: 3.9 [CI: 2.0-7.6]), and survival in AKI at seven days was 64% at 6, 12, and 24 months, HR: 3.13 (CI: 1.42-6.92). For the 12 dialysis patients survival was 82% at 6, 12, and 24 months. CONCLUSIONS: AKI after TAVR is associated with worse outcomes. Blood transfusion should be administered restrictively in TAVR. Patients with CKD, PAD, prior CABG, and TA approach require close surveillance as they are at risk for AKI through seven days after TAVR. doi: 10.1111/jocs.12768 (J Card Surg 2016;31:416-422).


Subject(s)
Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , Aortic Valve/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Transcatheter Aortic Valve Replacement , Acute Kidney Injury/mortality , Aged , Aged, 80 and over , Female , Humans , Incidence , Male , Peripheral Arterial Disease , Postoperative Complications/mortality , Renal Insufficiency, Chronic , Risk Factors , Survival Rate , Time Factors
15.
Am Heart J ; 167(6): 826-32, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24890531

ABSTRACT

UNLABELLED: Endothelial dysfunction is highly prevalent and associated with adverse outcomes among patients without obstructive coronary artery disease (CAD). Angiotensin II inhibition may improve endothelial function, but with continued treatment, "aldosterone escape" may occur. Thus, it is unknown if adding aldosterone blockade further improves endothelial function. METHODS: In a double-blind, parallel-group, repeated-measures study, women with symptoms and signs of ischemia, no significant CAD, and coronary endothelial dysfunction receiving an angiotensin-converting enzyme inhibitor or receptor blocker were randomized to aldosterone blockade or placebo. The primary outcome at 16 weeks was percent change in coronary diameter to acetylcholine, and secondary outcome, coronary flow reserve to adenosine, both adjusted for baseline reactivity. RESULTS: Forty-one women completed the treatment period with repeat coronary reactivity testing. Their mean age was 54 ± 10 years; body mass index, 30 ± 7.4 kg/m2; 12% had diabetes; and 15% had metabolic syndrome. There were no significant differences between treatment groups. At baseline, the percent change in reference vessel coronary diameter to acetylcholine was -5.0% in the aldosterone blockade group and -3.4% in the placebo group and, at 16 weeks, -7.2% in the aldosterone blockade group versus -14.3% in the placebo group (P = .15). At 16 weeks, the change in coronary flow reserve to intracoronary adenosine was -0.13 in the aldosterone blockade group versus -0.25 in the placebo group (P = .66). CONCLUSION: Adding aldosterone receptor blockade to angiotensin II inhibition did not improve coronary endothelial or microvascular function among women with signs and symptoms of ischemia in the setting of nonobstructive CAD.


Subject(s)
Acetylcholine/pharmacology , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Coronary Artery Disease/drug therapy , Endothelium, Vascular/drug effects , Mineralocorticoid Receptor Antagonists/therapeutic use , Spironolactone/analogs & derivatives , Vasodilator Agents/pharmacology , Adult , Aged , Cardiac Catheterization , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Vessels/diagnostic imaging , Coronary Vessels/drug effects , Double-Blind Method , Drug Therapy, Combination , Eplerenone , Female , Humans , Middle Aged , National Heart, Lung, and Blood Institute (U.S.) , Spironolactone/therapeutic use , Treatment Outcome , United States , Vasodilation
16.
Catheter Cardiovasc Interv ; 84(6): 973-7, 2014 Nov 15.
Article in English | MEDLINE | ID: mdl-24782350

ABSTRACT

OBJECTIVES: We sought to update our meta-analysis on clinical outcomes with aspiration thrombectomy prior to primary percutaneous coronary intervention (PPCI) compared with conventional PPCI alone due to the availability of additional trial data. BACKGROUND: The clinical efficacy of adjunctive aspiration thrombectomy in ST-elevation myocardial infarction (STEMI) patients undergoing PPCI remains controversial. A recent large-scale randomized trial showed no benefit in terms of mortality at 30 days. METHODS: Clinical trials that randomized STEMI patients to aspiration thrombectomy prior to PPCI compared with conventional PPCI alone were included. RESULTS: A total of 11,321 patients from 20 randomized controlled trials were included. The composite major adverse cardiac event (MACE) endpoint was lower in the aspiration thrombectomy arm compared with conventional PPCI alone (risk ratio [RR] = 0.81, 95% CI 0.70-0.94; P = 0.006). Although all-cause mortality was similar between the adjunctive aspiration thrombectomy arm and PPCI arms (RR = 0.83, 95% CI 0.67-1.01; P = 0.06), late mortality (6-12 months) was significantly reduced (RR = 0.64; 95% CI 0.44-0.92; P = 0.016). Reinfarction (RR = 0.64, 95% CI 0.44-0.92; P = 0.017) and stent thrombosis (RR = 0.54; 95% CI 0.32-0.91; P = 0.021) were similarly lower. Differences in target vessel revascularization were of borderline significance (RR = 0.83, 95% CI 0.68-1.01; P = 0.06). CONCLUSIONS: Our meta-analysis including all randomized controlled trials on aspiration thrombectomy to date demonstrates a significant reduction in adverse clinical outcomes including stent thrombosis compared with conventional PCI alone.


Subject(s)
Coronary Thrombosis/therapy , Myocardial Infarction/therapy , Percutaneous Coronary Intervention , Thrombectomy/methods , Coronary Thrombosis/diagnosis , Coronary Thrombosis/mortality , Humans , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Odds Ratio , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Randomized Controlled Trials as Topic , Recurrence , Risk Assessment , Risk Factors , Suction , Thrombectomy/adverse effects , Thrombectomy/mortality , Time Factors , Treatment Outcome
17.
Catheter Cardiovasc Interv ; 84(6): 978-86, 2014 Nov 15.
Article in English | MEDLINE | ID: mdl-24948465

ABSTRACT

OBJECTIVES: To conduct a meta-analysis on surrogate and clinical outcomes with myocardial ischemic postconditioning (IPoC) following revascularization with primary percutaneous intervention (PPCI) for ST-segment myocardial infarction (STEMI) compared with PPCI alone. BACKGROUND: Reperfusion injury remains an important problem following PPCI for STEMI. Trials of IPoC have mainly focused on cardiac biomarkers; the impact on clinical outcomes is unknown. METHODS: Clinical trials that randomized STEMI patients to IPoC as compared with conventional PPCI were included for analysis. RESULTS: A total of 15 randomized trials with 1,545 patients met our selection criteria (785 underwent IPoC + PPCI, 760 PPCI alone). Mean follow-up for clinical outcomes was 4.7 months. The mean ischemic time was 225 min. ST-segment resolution (Relative Risk [RR] = 0.98; 95% Confidence Intervals [CI] 0.85-1.13; P = 0.75) and infarct size (Weighted mean difference [WMD] = -2.53%, 95% CI -6.10 to 1.05; P = 0.17) were similar between the IPoC + PPCI vs. PPCI arms. Left ventricular ejection fraction at follow-up was marginally higher in the IPoC (WMD = 4.15%, 95% CI 0.19-8.12%, P = 0.04). No differences were noted in any of the clinical outcomes studied, including mortality (RR = 1.52; 95% CI 0.77-2.99; P = 0.23), recurrent MI (RR = 3.04; 95% CI 0.74-12.54; P = 0.12); stent thrombosis (RR = 1.24, 95% CI 0.51-3.04; P = 0.83) or the composite MACE outcome (RR = 1.53; 95% CI 0.89-2.63; P = 0.13). CONCLUSIONS: IPoC following PPCI is not associated with improvements in surrogate or clinical outcomes at 5 months as compared with PPCI alone. Our findings indicate no role for IPoC in the routine management of patients with STEMI.


Subject(s)
Ischemic Postconditioning , Myocardial Infarction/therapy , Myocardial Reperfusion Injury/prevention & control , Percutaneous Coronary Intervention/adverse effects , Humans , Ischemic Postconditioning/adverse effects , Ischemic Postconditioning/mortality , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Myocardial Reperfusion Injury/diagnosis , Myocardial Reperfusion Injury/etiology , Myocardial Reperfusion Injury/mortality , Percutaneous Coronary Intervention/mortality , Randomized Controlled Trials as Topic , Recurrence , Risk Factors , Time Factors , Treatment Outcome
18.
JACC Cardiovasc Interv ; 17(4): 505-515, 2024 Feb 26.
Article in English | MEDLINE | ID: mdl-38340102

ABSTRACT

BACKGROUND: A single, multitiered valve center designation has been proposed to publicly identify centers with expertise for all valve therapies. The correlation between transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (MTEER) procedures is unknown. OBJECTIVES: The authors sought to examine the relationship between site-level volumes and outcomes for TAVR and MTEER. We further explored variability between sites for MTEER outcomes. METHODS: Using the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) national registry, TAVR and MTEER procedures at sites offering both therapies from 2013 to 2022 were examined. Sites were ranked into deciles of adjusted in-hospital and 30-day outcomes separately for TAVR and MTEER and compared. Stepwise, hierarchical multivariable models were constructed for MTEER outcomes, and the median OR was calculated. RESULTS: Between 2013 and 2022, 384,394 TAVRs and 53,274 MTEERs (median annualized volumes: 93.6 and 18.8, respectively) were performed across 453 U.S. sites. Annualized TAVR and MTEER volumes were moderately correlated (r = 0.48; P < 0.001). After adjustment, 14.3% of sites had the same decile rank for TAVR and MTEER 30-day composite outcome, 50.6% were within 2 decile ranks; 35% had more discordant outcomes for the 2 procedures (P = 0.0005). For MTEER procedures, the median OR for the 30-day composite outcome was 1.57 (95% CI: 1.51-1.64), indicating a 57% variability in outcome by site. CONCLUSIONS: There is modest correlation between hospital-level volumes for TAVR and MTEER but low interprocedural correlation of outcomes. For similar patients, site-level variability for mortality/morbidity following MTEER was high. Factors influencing outcomes and "centers of excellence" as a whole may differ for TAVR and MTEER.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , United States , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/etiology , Treatment Outcome , Registries , Hospitals , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Risk Factors
19.
Am J Cardiol ; 221: 19-28, 2024 06 15.
Article in English | MEDLINE | ID: mdl-38583700

ABSTRACT

Cardiogenic shock after acute myocardial infarction (AMI-CS) carries significant mortality despite advances in revascularization and mechanical circulatory support. We sought to identify the process-based and structural characteristics of centers with lower mortality in AMI-CS. We analyzed 16,337 AMI-CS cases across 440 centers enrolled in the National Cardiovascular Data Registry's Chest Pain-MI Registry, a retrospective cohort database, between January 1, 2015, and December 31, 2018. Centers were stratified across tertiles of risk-adjusted in-hospital mortality rate (RAMR) for comparison. Risk-adjusted multivariable logistic regression was also performed to identify hospital-level characteristics associated with decreased mortality. The median participant age was 66 (interquartile range 57 to 75) years, and 33.0% (n = 5,390) were women. The median RAMR was 33.4% (interquartile range 26.0% to 40.0%) and ranged from 26.9% to 50.2% across tertiles. Even after risk adjustment, lower-RAMR centers saw patients with fewer co-morbidities. Lower-RAMR centers performed more revascularization (92.8% vs 90.6% vs 85.9%, p <0.001) and demonstrated better adherence to associated process measures. Left ventricular assist device capability (odds ratio [OR] 0.78 [0.67 to 0.92], p = 0.002), more frequent revascularization (OR 0.93 [0.88 to 0.98], p = 0.006), and higher AMI-CS volume (OR 0.95 [0.91 to 0.99], p = 0.009) were associated with lower in-hospital mortality. However, several such characteristics were not more frequently observed at low-RAMR centers, despite potentially reflecting greater institutional experience or resources. This may reflect the heterogeneity of AMI-CS even after risk adjustment. In conclusion, low-RAMR centers do not necessarily exhibit factors associated with decreased mortality in AMI-CS, which may reflect the challenges in performing outcomes research in this complex population.


Subject(s)
Hospital Mortality , Myocardial Infarction , Registries , Shock, Cardiogenic , Humans , Female , Male , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality , Shock, Cardiogenic/therapy , Middle Aged , Aged , Myocardial Infarction/complications , Myocardial Infarction/mortality , Retrospective Studies , United States/epidemiology , Hospitals, High-Volume , Myocardial Revascularization/statistics & numerical data
20.
Circ Cardiovasc Interv ; 17(2): e013298, 2024 02.
Article in English | MEDLINE | ID: mdl-38235547

ABSTRACT

BACKGROUND: Frailty associates with worse outcomes after transcatheter aortic valve replacement (TAVR). Sarcopenia underlies frailty, but the association between a comprehensive assessment of sarcopenia-muscle mass, strength, and performance-and outcomes after TAVR has not been examined. METHODS: From a multicenter prospective registry of patients with symptomatic severe aortic stenosis undergoing TAVR, 445 who had a preprocedure computed tomography and clinical assessment of frailty were included. Cross-sectional muscle (psoas and paraspinal) areas were measured on computed tomography and indexed to height. Gait speed and handgrip strength were obtained, and patients were dichotomized into fast versus slow; strong versus weak; and normal versus low muscle mass. As measures of body composition, cross-sectional fat (subcutaneous and visceral) was measured and indexed to height. RESULTS: The frequency of patients who were slow, weak, and had low muscle mass was 56%, 59%, and 42%, respectively. Among the 3 components of sarcopenia, only slower gait speed (muscle performance) was independently associated with increased post-TAVR mortality (adjusted hazard ratio, 1.12 per 0.1 m/s decrease [95% CI, 1.04-1.21]; P=0.004; adjusted hazard ratio, 1.38 per 1 SD decrease [95% CI, 1.11-1.72]; P=0.004). Meeting multiple sarcopenia criteria was not associated with higher mortality risk than fewer. Lower indexed visceral fat area (adjusted hazard ratio, 1.48 per 1 SD decrease [95% CI, 1.15-1.89]; P=0.002) was associated with mortality but indexed subcutaneous fat was not. Death occurred in 169 (38%) patients. CONCLUSIONS: Among patients with symptomatic severe aortic stenosis and comprehensive sarcopenia and body composition phenotyping, gait speed was the only sarcopenia measure associated with post-TAVR mortality. Lower visceral fat was also associated with increased risk pointing to an obesity paradox also observed in other patient populations. These findings reinforce the clinical utility of gait speed as a measure of risk and a potential target for adjunctive interventions alongside TAVR to optimize clinical outcomes.


Subject(s)
Aortic Valve Stenosis , Frailty , Sarcopenia , Transcatheter Aortic Valve Replacement , Humans , Sarcopenia/diagnostic imaging , Sarcopenia/complications , Frailty/diagnosis , Frailty/complications , Treatment Outcome , Hand Strength , Cross-Sectional Studies , Risk Assessment , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Body Composition , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Risk Factors
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