Jay Giri - Academia.edu (original) (raw)

Papers by Jay Giri

Research paper thumbnail of Does Surgical Repair of Moderate Ischemic Mitral Regurgitation Improve Survival? A Systematic Review

Current cardiology reports, 2016

Mitral regurgitation (MR) is one of the common complications in myocardial infarction (MI) patien... more Mitral regurgitation (MR) is one of the common complications in myocardial infarction (MI) patients. Almost half of the post MI patients have MR (ischemic MR)(17) which is moderate to severe (grade II-IV). Whether there is a mortality benefit of performing mitral valve repair (MVR) along with coronary artery bypass grafting (CABG) in patients with post MI moderate MR remains inconclusive. Literature search was done from PubMed, Google scholar, Ovid, and Medline databases. Studies which included post MI patients with moderate ischemic MR and reported mortality outcomes of performing CABG and MVR were chosen for the systematic review. Our preliminary literature search identified 194 studies, of which 11 studies met our inclusion criteria. Nine studies showed no survival benefit of performing simultaneous MVR and CABG. One study demonstrated survival benefit of performing CABG plus MVR only in the New York Heart Association (NYHA) class III-IV, and one study suggested survival benefit ...

Research paper thumbnail of Transradial Versus Transfemoral Access in Patients Undergoing Rescue Percutaneous Coronary Intervention After Fibrinolytic Therapy

JACC. Cardiovascular interventions, Jan 21, 2015

The purpose of this study was to assess usage patterns of transradial access in rescue percutaneo... more The purpose of this study was to assess usage patterns of transradial access in rescue percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) and associations between vascular access site choice and outcomes. Transradial access reduces bleeding and mortality in STEMI patients undergoing primary PCI. Little is known about access site choice and outcomes in patients undergoing rescue PCI after receiving full-dose fibrinolytic therapy for STEMI. Patients in the National Cardiovascular Data Registry's CathPCI Registry undergoing rescue PCI for STEMI between 2009 and 2013 were studied. Patients were divided on the basis of access site. Patterns of access use and baseline demographics were noted. Unadjusted and propensity-matched analyses were performed comparing in-hospital bleeding, vascular complications, and mortality outcomes among transradial and transfemoral access patients. The falsification endpoint of gastrointestinal bleeding was spe...

Research paper thumbnail of Statin Use and Functional Decline in Patients With and Without Peripheral Arterial Disease

J Amer Coll Cardiol, 2006

We determined whether statin use (vs. non-use) is associated with less annual decline in lower-ex... more We determined whether statin use (vs. non-use) is associated with less annual decline in lower-extremity functioning in patients with and without lower-extremity peripheral arterial disease (PAD) over three-year follow-up.It is unclear whether statin use is associated with less functional decline in patients with PAD.Participants included 332 men and women with an ankle brachial index (ABI) <0.90 and 212 with ABI 0.90 to 1.50. Functional outcomes included 6-min walk distance and usual and rapid-pace 4-m walking velocity. A summary performance score combined performance in walking speed, standing balance, and time for five repeated chair rises into an ordinal score ranging from 0 to 12 (12 = best).Adjusting for age, race, gender, comorbidities, education, health insurance, total cholesterol/high-density lipoprotein level, body mass index, pack-years of smoking, leg symptoms, immediately previous year functioning, statin use/non-use, ABI, and change in ABI, the PAD participants using statins had less annual decline in usual-pace walking velocity (0.002 vs. −0.024 m/s/year, p = 0.013), rapid-pace walking velocity (−0.006 vs. −0.042 m/s/year, p = 0.006), 6-min walk performance (−34.5 vs. −57.9 feet/year, p = 0.088), and the summary performance score (−0.152 vs. −0.376, p = 0.067) compared with non-users. These associations were attenuated slightly by additional adjustment for high-sensitivity C-reactive protein levels. Among non-PAD participants, there were no significant associations between statin use and functional decline.The PAD patients on statins have less annual decline in lower-extremity performance than PAD patients who are not taking statins.

Research paper thumbnail of Endovascular therapy for acute ischaemic stroke: a systematic review and meta-analysis of randomized trials

European heart journal, Jan 12, 2015

Evidence from randomized controlled trials (RCTs) evaluating possible benefits of endovascular th... more Evidence from randomized controlled trials (RCTs) evaluating possible benefits of endovascular therapy (EVT) for acute ischaemic stroke has shown conflicting results. The purpose of this meta-analysis was to systematically examine clinical outcomes in RCTs comparing the use of intravenous (IV) fibrinolysis alone to IV fibrinolysis plus EVT, for the treatment of acute ischaemic stroke. We selected English language RCTs, comparing EVT plus IV tissue-type plasminogen activator (tPA) (if eligible) with IV tPA alone in eligible patients for the treatment of acute ischaemic stroke. The primary endpoint was good functional outcome [modified Rankin Scale (mRS) of 0-2]. Other major endpoints of interest were all-cause mortality and symptomatic intracerebral haemorrhage (sICH). The meta-analysis included 8 RCTs that randomized 2423 patients with large-vessel, anterior-circulation stroke. EVT significantly improved the rate of functional independence (90-day mRS of 0-2) when compared with IV f...

Research paper thumbnail of Outcomes of transcatheter aortic valve replacement in patients with chronic liver disease

Catheterization and Cardiovascular Interventions, 2015

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to high-risk surgery ... more Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to high-risk surgery in patients with comorbid conditions. The role of TAVR in patients with liver disease has not been examined. We examined the procedural and intermediate to long-term follow-up outcomes of patients with severe symptomatic aortic valve stenosis and chronic liver disease, identified by liver biopsy or from a combination of clinical findings. All patients were treated with balloon-expandable transfemoral (TF) or transapical (TA) TAVR between November 2007 and February 2014. A total of 17 of 706 (2.41%) patients treated at our institution with TF [n = 14] or TA [n = 3] TAVR had chronic liver disease (mean age 77.65 ± 9.06 years, 7 women, mean STS score 8.37, mean Charlson score 5.00, mean MELD score 11.35, Child-Turcotte-Pugh (CTP) Class A [n = 11], B [n = 6], C [n = 0], biopsy proven liver disease [n = 5]). Median follow-up was 466 days (range = 12-1,403 days). The mean post-procedure length of hospital stay was 5.88 ± 3.08 days. Procedural success was achieved in all cases. In-hospital mortality was 5.88% and 90-day mortality was 17.65%. Safety and efficacy endpoints as defined by the valve academic research consortium (VARC) were significant for one perioperative death from a proximate cardiac cause (post-operative day 14), one death after hospital discharge of unknown cause (post-operative day 12), two late deaths from non-cardiac causes (post-operative days 50 and 487, respectively), and one late death of unknown cause (post-operative day 1,005). There were no life-threatening or major bleeding complications. One patient had an MI, one had a transient ischemic attack, four had transient, Stage I, acute kidney injury and one had transient, Stage II, acute kidney injury. TF and TA TAVR are feasible methods for treating aortic stenosis in patients with chronic liver disease. In patients with mild to moderate chronic liver disease there are acceptable rates of early and late complications, however, outcomes in patients with advanced liver disease (MELD &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;20 or CTP class C) warrant further study. © 2015 Wiley Periodicals, Inc.

Research paper thumbnail of Anti-platelet and anti-hypertension medication use in patients with fibromuscular dysplasia: Results from the United States Registry for Fibromuscular Dysplasia

Vascular medicine (London, England), Jan 11, 2015

Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hype... more Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular ...

Research paper thumbnail of Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device

JAMA Internal Medicine, 2015

The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-ti... more The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. Procedural adverse events and procedural success. In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA exclusion. Formal, controlled investigations into the safety and efficacy of the device for this indication are warranted.

Research paper thumbnail of Beyond blood pressure: percutaneous renal denervation for the management of sympathetic hyperactivity and associated disease States

Journal of the American Heart Association, 2015

Research paper thumbnail of Novel Anti-platelet Agents in Acute Coronary Syndrome: Mechanisms of Action and Opportunities to Tailor Therapy

Current atherosclerosis reports, 2015

Dual anti-platelet therapy, most commonly aspirin and clopidogrel, has been the standard of care ... more Dual anti-platelet therapy, most commonly aspirin and clopidogrel, has been the standard of care for over a decade in patients who have experienced acute coronary syndrome, particularly when treated with coronary stenting. However, residual risk in patients receiving dual anti-platelet therapy post-acute coronary syndrome raises an unmet need for alternative therapy to clopidogrel. Consequently, novel anti-platelets agents including the P2Y12 receptor antagonists, such as prasugrel and ticagrelor, have emerged. Furthermore, using new methods to assess genetic polymorphisms and functional phenotypic assessments of platelet reactivity may become important in the development of personalized medicine and in developing tailored approaches to individual treatment. While robust large-scale evidence for genotypic- and phenotypic-guided therapy in improving outcomes is currently lacking, tremendous interest from various stakeholders including researchers, funding agencies, and industry conti...

Research paper thumbnail of Associations of Known Complications With Transcatheter Implantation of First-Generation Balloon Expandable Edwards-Sapien Aortic Valves With Peri-Procedural Mortality: An Insight From 2011-2014 Reports From the Fda Maude Database

Journal of the American College of Cardiology, 2015

Research paper thumbnail of Mortality, Expense and Length of Stay With Transcatheter Versus Surgical Aortic Valve Replacement in the First Year After Approval in the Us: An Analysis of the National Inpatient Sample Database

Journal of the American College of Cardiology, 2015

Research paper thumbnail of Treatment Discontinuations With New Oral Agents for Long-term Anticoagulation: Insights From a Meta-analysis of 18 Randomized Trials Including 101,801 Patients

Mayo Clinic Proceedings, 2014

To systematically examine discontinuation rates with new US Food and Drug Administration-approved... more To systematically examine discontinuation rates with new US Food and Drug Administration-approved oral anticoagulants (NOACs) in patients with various indications for long-term anticoagulation. Poor adherence to medications is considered a potential and frequent cause of treatment failure. We searched the PubMed, Cochrane Central Register of Controlled Trials, EMBASE, EBSCO, Web of Science, and CINAHL databases for articles published from January 1, 2001, through September 15, 2013. The following Medical Subject Heading terms and/or keywords were used for our database searches: rivaroxaban, dabigatran, apixaban, new oral anticoagulants, oral thrombin inhibitors, and oral factor Xa inhibitors. Articles in English that focused on randomized controlled trials (RCTs) comparing NOACs (apixaban, dabigatran, and rivaroxaban) with conventional therapy or placebo were abstracted. Independent extraction of relevant data was performed by 2 authors. The primary end point of interest was discontinuation due to all causes. Other end points of interest were discontinuation due to adverse events, consent withdrawal, and nonadherence. Eighteen RCTs including a total of 101,801 patients were included for analysis. Total study drug discontinuation rates were not statistically different with NOACs in comparison to pharmacologically active comparators for treatment of venous thromboembolism/pulmonary embolism (risk ratio [RR], 0.91; 95% CI, 0.74-1.13; P=.40) and for NOACs in comparison to warfarin and aspirin for prevention of stroke in patients with atrial fibrillation (RR, 1.01; 95% CI, 0.87-1.17; P=.92). In contrast, in acute coronary syndromes, total study drug discontinuation with NOACs was significantly higher than with placebo (RR, 1.40; 95% CI, 1.07-1.83; P=.01). Overall discontinuations were comparable to those with active comparators. Study drug discontinuations with NOACs were not significantly different from those with conventional drugs in treatment of venous thromboembolism/pulmonary embolism and prevention of stroke in patients with atrial fibrillation but were worse in acute coronary syndromes as noted in evidence from contemporary RCTs.

Research paper thumbnail of Risk of major bleeding in different indications for new oral anticoagulants: Insights from a meta-analysis of approved dosages from 50 randomized trials

International Journal of Cardiology, 2015

Research paper thumbnail of CRT-803 TAVR in Patients with Liver Disease

JACC: Cardiovascular Interventions, 2015

Research paper thumbnail of Intervention strategies for multi-vessel disease in patients with ST-segment elevation myocardial infarction: A meta-analysis of randomized trials

International Journal of Cardiology, 2015

Multi-vessel disease (MVD) is common in patients with ST-segment elevation myocardial infarction ... more Multi-vessel disease (MVD) is common in patients with ST-segment elevation myocardial infarction (STEMI), with prevalence ranging from 30% to 80% [2]. Current consensus guidelines recommend intervention on only culprit vessels during primary percutaneous coronary intervention (PCI) for STEMI, unless hemodynamic compromise is present . This recommendation is based on a combination of older randomized trials (RCTs), observational data, and expert opinion. However, more recent RCTs have contradicted this guideline with benefits in combined cardiovascular (CV) endpoints seen in cohorts of patients treated with complete revascularization during STEMI . Hence, there is uncertainty regarding the relative benefits of complete revascularization for STEMI patients with MVD. Additionally in question is the proper timing of intervention on non-infarct lesions if a strategy of complete revascularization is opted for. Two different strategies can be adopted for complete revascularization, multivessel single-setting PCI during the index catheterization, or PCI on noninfract arteries at a later time as a staged procedure 2]. In order to address these issues, we performed a meta-analysis of all randomized trials (RCTs) to compare the various intervention strategies for MVD in STEMI.

Research paper thumbnail of Early Aneurysm Formation After Everolimus-Eluting Stent Implantation

Circulation: Cardiovascular Interventions, 2014

Research paper thumbnail of Factors Associated With Vascular Complications in Patients Undergoing Balloon-Expandable Transfemoral Transcatheter Aortic Valve Replacement via Open Versus Percutaneous Approaches

Circulation: Cardiovascular Interventions, 2014

Vascular complications after transfemoral transcatheter aortic valve replacement are common and a... more Vascular complications after transfemoral transcatheter aortic valve replacement are common and associated with significant morbidity and mortality. Little is known about the effect of access approach on vascular complications. Between 2007 and 2013, 331 patients underwent transfemoral transcatheter aortic valve replacement via open surgical (OS) or fully percutaneous (PC) approaches. Patient data and clinical outcomes were collected. Valve Academic Research Consortium-defined vascular complications were noted. Multivariable analysis with propensity matching was performed, and vascular complications, mortality, and length of stay were assessed. One hundred twenty patients were treated with the OS approach and 211 patients via the PC approach. There were fewer major vascular complications (11% versus 20%; P=0.03) and shorter length of stay (7.5 versus 9.9 days; P=0.003) in the PC group when compared with those in the OS group. In multivariable analysis, vascular complications were more likely in women (odds ratio, 2.2; P=0.02) and with increasing differences between sheath outer diameter and minimal artery diameter (overall vascular complications: odds ratio, 1.4; P=0.02 and major vascular complications: odds ratio, 2.0; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.001). Propensity-matched analysis demonstrated no difference in vascular complications between the OS and the PC groups (22% versus 19%; P=0.73) but significantly reduced length of stay in the PC group (7.9 versus 10.0 days; P=0.04). Transfemoral transcatheter aortic valve replacement performed via the PC route is associated with similar risk of vascular complications and significantly lower postprocedural length of stay than the OS route. The degree of sheath oversizing with respect to iliofemoral minimal artery diameter and female sex are associated with vascular complications regardless of access approach.

Research paper thumbnail of Thrombectomy using suction filtration and veno-venous bypass: Single center experience with a novel device

Catheterization and Cardiovascular Interventions, 2014

Objectives. To describe the first single center experience with a novel aspiration thrombectomy d... more Objectives. To describe the first single center experience with a novel aspiration thrombectomy device. Background. The appearance of inferior vena cava or right-sided intracardiac thrombus may prompt consideration of percutaneous thrombectomy as a method to prevent new or worsening pulmonary embolism (PE). The AngioVac is a novel thrombectomy device composed of a cannula and extracorporeal circuit with filter for pump-assisted removal of intravascular debris which is coupled with a reinfusion catheter for return of blood to the patient. The device has been approved by the United States Food and Drug Administration since 2009. This report represents the first significant case series describing its use, feasibility and outcomes in evacuating large caval thrombi or intracardiac masses in PE. Methods. This is a retrospective analysis of patient and case characteristics and in-hospital clinical outcomes of AngioVac thrombectomy in 14 consecutive patients treated between April 2010 and July 2013 at our institution. Results. Fourteen consecutive patients (mean age 50, 64% female) underwent 15 AngioVac procedures over 40 months. Indications included intracardiac mass (73%), acute pulmonary embolism (33%) and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Peri-procedure mortality was 0% and in-hospital mortality was 13% at a mean follow-up of 23 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. Though 73% had a post procedural drop in hematocrit, only two bleeding events were related to access site and required a transfusion. Conclusions. AngioVac thrombectomy is feasible in critically ill patients with acute DVT or PE and large caval thrombi or intracardiac masses. © 2014 Wiley Periodicals, Inc.

Research paper thumbnail of Raising Lazarus: reassessing renal denervation after SIMPLICITY HTN 3

Interventional Cardiology, 2014

Research paper thumbnail of Thrombolysis for Pulmonary Embolism and Risk of All-Cause Mortality, Major Bleeding, and Intracranial Hemorrhage

JAMA, 2014

Thrombolytic therapy may be beneficial in the treatment of some patients with pulmonary embolism.... more Thrombolytic therapy may be beneficial in the treatment of some patients with pulmonary embolism. To date, no analysis has had adequate statistical power to determine whether thrombolytic therapy is associated with improved survival, compared with conventional anticoagulation. To determine mortality benefits and bleeding risks associated with thrombolytic therapy compared with anticoagulation in acute pulmonary embolism, including the subset of hemodynamically stable patients with right ventricular dysfunction (intermediate-risk pulmonary embolism). PubMed, the Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from inception through April 10, 2014. Eligible studies were randomized clinical trials comparing thrombolytic therapy vs anticoagulant therapy in pulmonary embolism patients. Sixteen trials comprising 2115 individuals were identified. Eight trials comprising 1775 patients specified inclusion of patients with intermediate-risk pulmonary embolism. Two reviewers independently extracted trial-level data including number of patients, patient characteristics, duration of follow-up, and outcomes. The primary outcomes were all-cause mortality and major bleeding. Secondary outcomes were risk of recurrent embolism and intracranial hemorrhage (ICH). Peto odds ratio (OR) estimates and associated 95% CIs were calculated using a fixed-effects model. Use of thrombolytics was associated with lower all-cause mortality (OR, 0.53; 95% CI, 0.32-0.88; 2.17% [23/1061] vs 3.89% [41/1054] with anticoagulants; number needed to treat [NNT] = 59) and greater risks of major bleeding (OR, 2.73; 95% CI, 1.91-3.91; 9.24% [98/1061] vs 3.42% [36/1054]; number needed to harm [NNH] = 18) and ICH (OR, 4.63; 95% CI, 1.78-12.04; 1.46% [15/1024] vs 0.19% [2/1019]; NNH = 78). Major bleeding was not significantly increased in patients 65 years and younger (OR, 1.25; 95% CI, 0.50-3.14). Thrombolysis was associated with a lower risk of recurrent pulmonary embolism (OR, 0.40; 95% CI, 0.22-0.74; 1.17% [12/1024] vs 3.04% [31/1019]; NNT = 54). In intermediate-risk pulmonary embolism trials, thrombolysis was associated with lower mortality (OR, 0.48; 95% CI, 0.25-0.92) and more major bleeding events (OR, 3.19; 95% CI, 2.07-4.92). Among patients with pulmonary embolism, including those who were hemodynamically stable with right ventricular dysfunction, thrombolytic therapy was associated with lower rates of all-cause mortality and increased risks of major bleeding and ICH. However, findings may not apply to patients with pulmonary embolism who are hemodynamically stable without right ventricular dysfunction.

Research paper thumbnail of Does Surgical Repair of Moderate Ischemic Mitral Regurgitation Improve Survival? A Systematic Review

Current cardiology reports, 2016

Mitral regurgitation (MR) is one of the common complications in myocardial infarction (MI) patien... more Mitral regurgitation (MR) is one of the common complications in myocardial infarction (MI) patients. Almost half of the post MI patients have MR (ischemic MR)(17) which is moderate to severe (grade II-IV). Whether there is a mortality benefit of performing mitral valve repair (MVR) along with coronary artery bypass grafting (CABG) in patients with post MI moderate MR remains inconclusive. Literature search was done from PubMed, Google scholar, Ovid, and Medline databases. Studies which included post MI patients with moderate ischemic MR and reported mortality outcomes of performing CABG and MVR were chosen for the systematic review. Our preliminary literature search identified 194 studies, of which 11 studies met our inclusion criteria. Nine studies showed no survival benefit of performing simultaneous MVR and CABG. One study demonstrated survival benefit of performing CABG plus MVR only in the New York Heart Association (NYHA) class III-IV, and one study suggested survival benefit ...

Research paper thumbnail of Transradial Versus Transfemoral Access in Patients Undergoing Rescue Percutaneous Coronary Intervention After Fibrinolytic Therapy

JACC. Cardiovascular interventions, Jan 21, 2015

The purpose of this study was to assess usage patterns of transradial access in rescue percutaneo... more The purpose of this study was to assess usage patterns of transradial access in rescue percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) and associations between vascular access site choice and outcomes. Transradial access reduces bleeding and mortality in STEMI patients undergoing primary PCI. Little is known about access site choice and outcomes in patients undergoing rescue PCI after receiving full-dose fibrinolytic therapy for STEMI. Patients in the National Cardiovascular Data Registry's CathPCI Registry undergoing rescue PCI for STEMI between 2009 and 2013 were studied. Patients were divided on the basis of access site. Patterns of access use and baseline demographics were noted. Unadjusted and propensity-matched analyses were performed comparing in-hospital bleeding, vascular complications, and mortality outcomes among transradial and transfemoral access patients. The falsification endpoint of gastrointestinal bleeding was spe...

Research paper thumbnail of Statin Use and Functional Decline in Patients With and Without Peripheral Arterial Disease

J Amer Coll Cardiol, 2006

We determined whether statin use (vs. non-use) is associated with less annual decline in lower-ex... more We determined whether statin use (vs. non-use) is associated with less annual decline in lower-extremity functioning in patients with and without lower-extremity peripheral arterial disease (PAD) over three-year follow-up.It is unclear whether statin use is associated with less functional decline in patients with PAD.Participants included 332 men and women with an ankle brachial index (ABI) <0.90 and 212 with ABI 0.90 to 1.50. Functional outcomes included 6-min walk distance and usual and rapid-pace 4-m walking velocity. A summary performance score combined performance in walking speed, standing balance, and time for five repeated chair rises into an ordinal score ranging from 0 to 12 (12 = best).Adjusting for age, race, gender, comorbidities, education, health insurance, total cholesterol/high-density lipoprotein level, body mass index, pack-years of smoking, leg symptoms, immediately previous year functioning, statin use/non-use, ABI, and change in ABI, the PAD participants using statins had less annual decline in usual-pace walking velocity (0.002 vs. −0.024 m/s/year, p = 0.013), rapid-pace walking velocity (−0.006 vs. −0.042 m/s/year, p = 0.006), 6-min walk performance (−34.5 vs. −57.9 feet/year, p = 0.088), and the summary performance score (−0.152 vs. −0.376, p = 0.067) compared with non-users. These associations were attenuated slightly by additional adjustment for high-sensitivity C-reactive protein levels. Among non-PAD participants, there were no significant associations between statin use and functional decline.The PAD patients on statins have less annual decline in lower-extremity performance than PAD patients who are not taking statins.

Research paper thumbnail of Endovascular therapy for acute ischaemic stroke: a systematic review and meta-analysis of randomized trials

European heart journal, Jan 12, 2015

Evidence from randomized controlled trials (RCTs) evaluating possible benefits of endovascular th... more Evidence from randomized controlled trials (RCTs) evaluating possible benefits of endovascular therapy (EVT) for acute ischaemic stroke has shown conflicting results. The purpose of this meta-analysis was to systematically examine clinical outcomes in RCTs comparing the use of intravenous (IV) fibrinolysis alone to IV fibrinolysis plus EVT, for the treatment of acute ischaemic stroke. We selected English language RCTs, comparing EVT plus IV tissue-type plasminogen activator (tPA) (if eligible) with IV tPA alone in eligible patients for the treatment of acute ischaemic stroke. The primary endpoint was good functional outcome [modified Rankin Scale (mRS) of 0-2]. Other major endpoints of interest were all-cause mortality and symptomatic intracerebral haemorrhage (sICH). The meta-analysis included 8 RCTs that randomized 2423 patients with large-vessel, anterior-circulation stroke. EVT significantly improved the rate of functional independence (90-day mRS of 0-2) when compared with IV f...

Research paper thumbnail of Outcomes of transcatheter aortic valve replacement in patients with chronic liver disease

Catheterization and Cardiovascular Interventions, 2015

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to high-risk surgery ... more Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to high-risk surgery in patients with comorbid conditions. The role of TAVR in patients with liver disease has not been examined. We examined the procedural and intermediate to long-term follow-up outcomes of patients with severe symptomatic aortic valve stenosis and chronic liver disease, identified by liver biopsy or from a combination of clinical findings. All patients were treated with balloon-expandable transfemoral (TF) or transapical (TA) TAVR between November 2007 and February 2014. A total of 17 of 706 (2.41%) patients treated at our institution with TF [n = 14] or TA [n = 3] TAVR had chronic liver disease (mean age 77.65 ± 9.06 years, 7 women, mean STS score 8.37, mean Charlson score 5.00, mean MELD score 11.35, Child-Turcotte-Pugh (CTP) Class A [n = 11], B [n = 6], C [n = 0], biopsy proven liver disease [n = 5]). Median follow-up was 466 days (range = 12-1,403 days). The mean post-procedure length of hospital stay was 5.88 ± 3.08 days. Procedural success was achieved in all cases. In-hospital mortality was 5.88% and 90-day mortality was 17.65%. Safety and efficacy endpoints as defined by the valve academic research consortium (VARC) were significant for one perioperative death from a proximate cardiac cause (post-operative day 14), one death after hospital discharge of unknown cause (post-operative day 12), two late deaths from non-cardiac causes (post-operative days 50 and 487, respectively), and one late death of unknown cause (post-operative day 1,005). There were no life-threatening or major bleeding complications. One patient had an MI, one had a transient ischemic attack, four had transient, Stage I, acute kidney injury and one had transient, Stage II, acute kidney injury. TF and TA TAVR are feasible methods for treating aortic stenosis in patients with chronic liver disease. In patients with mild to moderate chronic liver disease there are acceptable rates of early and late complications, however, outcomes in patients with advanced liver disease (MELD &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;20 or CTP class C) warrant further study. © 2015 Wiley Periodicals, Inc.

Research paper thumbnail of Anti-platelet and anti-hypertension medication use in patients with fibromuscular dysplasia: Results from the United States Registry for Fibromuscular Dysplasia

Vascular medicine (London, England), Jan 11, 2015

Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hype... more Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular ...

Research paper thumbnail of Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device

JAMA Internal Medicine, 2015

The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-ti... more The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. Procedural adverse events and procedural success. In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA exclusion. Formal, controlled investigations into the safety and efficacy of the device for this indication are warranted.

Research paper thumbnail of Beyond blood pressure: percutaneous renal denervation for the management of sympathetic hyperactivity and associated disease States

Journal of the American Heart Association, 2015

Research paper thumbnail of Novel Anti-platelet Agents in Acute Coronary Syndrome: Mechanisms of Action and Opportunities to Tailor Therapy

Current atherosclerosis reports, 2015

Dual anti-platelet therapy, most commonly aspirin and clopidogrel, has been the standard of care ... more Dual anti-platelet therapy, most commonly aspirin and clopidogrel, has been the standard of care for over a decade in patients who have experienced acute coronary syndrome, particularly when treated with coronary stenting. However, residual risk in patients receiving dual anti-platelet therapy post-acute coronary syndrome raises an unmet need for alternative therapy to clopidogrel. Consequently, novel anti-platelets agents including the P2Y12 receptor antagonists, such as prasugrel and ticagrelor, have emerged. Furthermore, using new methods to assess genetic polymorphisms and functional phenotypic assessments of platelet reactivity may become important in the development of personalized medicine and in developing tailored approaches to individual treatment. While robust large-scale evidence for genotypic- and phenotypic-guided therapy in improving outcomes is currently lacking, tremendous interest from various stakeholders including researchers, funding agencies, and industry conti...

Research paper thumbnail of Associations of Known Complications With Transcatheter Implantation of First-Generation Balloon Expandable Edwards-Sapien Aortic Valves With Peri-Procedural Mortality: An Insight From 2011-2014 Reports From the Fda Maude Database

Journal of the American College of Cardiology, 2015

Research paper thumbnail of Mortality, Expense and Length of Stay With Transcatheter Versus Surgical Aortic Valve Replacement in the First Year After Approval in the Us: An Analysis of the National Inpatient Sample Database

Journal of the American College of Cardiology, 2015

Research paper thumbnail of Treatment Discontinuations With New Oral Agents for Long-term Anticoagulation: Insights From a Meta-analysis of 18 Randomized Trials Including 101,801 Patients

Mayo Clinic Proceedings, 2014

To systematically examine discontinuation rates with new US Food and Drug Administration-approved... more To systematically examine discontinuation rates with new US Food and Drug Administration-approved oral anticoagulants (NOACs) in patients with various indications for long-term anticoagulation. Poor adherence to medications is considered a potential and frequent cause of treatment failure. We searched the PubMed, Cochrane Central Register of Controlled Trials, EMBASE, EBSCO, Web of Science, and CINAHL databases for articles published from January 1, 2001, through September 15, 2013. The following Medical Subject Heading terms and/or keywords were used for our database searches: rivaroxaban, dabigatran, apixaban, new oral anticoagulants, oral thrombin inhibitors, and oral factor Xa inhibitors. Articles in English that focused on randomized controlled trials (RCTs) comparing NOACs (apixaban, dabigatran, and rivaroxaban) with conventional therapy or placebo were abstracted. Independent extraction of relevant data was performed by 2 authors. The primary end point of interest was discontinuation due to all causes. Other end points of interest were discontinuation due to adverse events, consent withdrawal, and nonadherence. Eighteen RCTs including a total of 101,801 patients were included for analysis. Total study drug discontinuation rates were not statistically different with NOACs in comparison to pharmacologically active comparators for treatment of venous thromboembolism/pulmonary embolism (risk ratio [RR], 0.91; 95% CI, 0.74-1.13; P=.40) and for NOACs in comparison to warfarin and aspirin for prevention of stroke in patients with atrial fibrillation (RR, 1.01; 95% CI, 0.87-1.17; P=.92). In contrast, in acute coronary syndromes, total study drug discontinuation with NOACs was significantly higher than with placebo (RR, 1.40; 95% CI, 1.07-1.83; P=.01). Overall discontinuations were comparable to those with active comparators. Study drug discontinuations with NOACs were not significantly different from those with conventional drugs in treatment of venous thromboembolism/pulmonary embolism and prevention of stroke in patients with atrial fibrillation but were worse in acute coronary syndromes as noted in evidence from contemporary RCTs.

Research paper thumbnail of Risk of major bleeding in different indications for new oral anticoagulants: Insights from a meta-analysis of approved dosages from 50 randomized trials

International Journal of Cardiology, 2015

Research paper thumbnail of CRT-803 TAVR in Patients with Liver Disease

JACC: Cardiovascular Interventions, 2015

Research paper thumbnail of Intervention strategies for multi-vessel disease in patients with ST-segment elevation myocardial infarction: A meta-analysis of randomized trials

International Journal of Cardiology, 2015

Multi-vessel disease (MVD) is common in patients with ST-segment elevation myocardial infarction ... more Multi-vessel disease (MVD) is common in patients with ST-segment elevation myocardial infarction (STEMI), with prevalence ranging from 30% to 80% [2]. Current consensus guidelines recommend intervention on only culprit vessels during primary percutaneous coronary intervention (PCI) for STEMI, unless hemodynamic compromise is present . This recommendation is based on a combination of older randomized trials (RCTs), observational data, and expert opinion. However, more recent RCTs have contradicted this guideline with benefits in combined cardiovascular (CV) endpoints seen in cohorts of patients treated with complete revascularization during STEMI . Hence, there is uncertainty regarding the relative benefits of complete revascularization for STEMI patients with MVD. Additionally in question is the proper timing of intervention on non-infarct lesions if a strategy of complete revascularization is opted for. Two different strategies can be adopted for complete revascularization, multivessel single-setting PCI during the index catheterization, or PCI on noninfract arteries at a later time as a staged procedure 2]. In order to address these issues, we performed a meta-analysis of all randomized trials (RCTs) to compare the various intervention strategies for MVD in STEMI.

Research paper thumbnail of Early Aneurysm Formation After Everolimus-Eluting Stent Implantation

Circulation: Cardiovascular Interventions, 2014

Research paper thumbnail of Factors Associated With Vascular Complications in Patients Undergoing Balloon-Expandable Transfemoral Transcatheter Aortic Valve Replacement via Open Versus Percutaneous Approaches

Circulation: Cardiovascular Interventions, 2014

Vascular complications after transfemoral transcatheter aortic valve replacement are common and a... more Vascular complications after transfemoral transcatheter aortic valve replacement are common and associated with significant morbidity and mortality. Little is known about the effect of access approach on vascular complications. Between 2007 and 2013, 331 patients underwent transfemoral transcatheter aortic valve replacement via open surgical (OS) or fully percutaneous (PC) approaches. Patient data and clinical outcomes were collected. Valve Academic Research Consortium-defined vascular complications were noted. Multivariable analysis with propensity matching was performed, and vascular complications, mortality, and length of stay were assessed. One hundred twenty patients were treated with the OS approach and 211 patients via the PC approach. There were fewer major vascular complications (11% versus 20%; P=0.03) and shorter length of stay (7.5 versus 9.9 days; P=0.003) in the PC group when compared with those in the OS group. In multivariable analysis, vascular complications were more likely in women (odds ratio, 2.2; P=0.02) and with increasing differences between sheath outer diameter and minimal artery diameter (overall vascular complications: odds ratio, 1.4; P=0.02 and major vascular complications: odds ratio, 2.0; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.001). Propensity-matched analysis demonstrated no difference in vascular complications between the OS and the PC groups (22% versus 19%; P=0.73) but significantly reduced length of stay in the PC group (7.9 versus 10.0 days; P=0.04). Transfemoral transcatheter aortic valve replacement performed via the PC route is associated with similar risk of vascular complications and significantly lower postprocedural length of stay than the OS route. The degree of sheath oversizing with respect to iliofemoral minimal artery diameter and female sex are associated with vascular complications regardless of access approach.

Research paper thumbnail of Thrombectomy using suction filtration and veno-venous bypass: Single center experience with a novel device

Catheterization and Cardiovascular Interventions, 2014

Objectives. To describe the first single center experience with a novel aspiration thrombectomy d... more Objectives. To describe the first single center experience with a novel aspiration thrombectomy device. Background. The appearance of inferior vena cava or right-sided intracardiac thrombus may prompt consideration of percutaneous thrombectomy as a method to prevent new or worsening pulmonary embolism (PE). The AngioVac is a novel thrombectomy device composed of a cannula and extracorporeal circuit with filter for pump-assisted removal of intravascular debris which is coupled with a reinfusion catheter for return of blood to the patient. The device has been approved by the United States Food and Drug Administration since 2009. This report represents the first significant case series describing its use, feasibility and outcomes in evacuating large caval thrombi or intracardiac masses in PE. Methods. This is a retrospective analysis of patient and case characteristics and in-hospital clinical outcomes of AngioVac thrombectomy in 14 consecutive patients treated between April 2010 and July 2013 at our institution. Results. Fourteen consecutive patients (mean age 50, 64% female) underwent 15 AngioVac procedures over 40 months. Indications included intracardiac mass (73%), acute pulmonary embolism (33%) and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Peri-procedure mortality was 0% and in-hospital mortality was 13% at a mean follow-up of 23 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. Though 73% had a post procedural drop in hematocrit, only two bleeding events were related to access site and required a transfusion. Conclusions. AngioVac thrombectomy is feasible in critically ill patients with acute DVT or PE and large caval thrombi or intracardiac masses. © 2014 Wiley Periodicals, Inc.

Research paper thumbnail of Raising Lazarus: reassessing renal denervation after SIMPLICITY HTN 3

Interventional Cardiology, 2014

Research paper thumbnail of Thrombolysis for Pulmonary Embolism and Risk of All-Cause Mortality, Major Bleeding, and Intracranial Hemorrhage

JAMA, 2014

Thrombolytic therapy may be beneficial in the treatment of some patients with pulmonary embolism.... more Thrombolytic therapy may be beneficial in the treatment of some patients with pulmonary embolism. To date, no analysis has had adequate statistical power to determine whether thrombolytic therapy is associated with improved survival, compared with conventional anticoagulation. To determine mortality benefits and bleeding risks associated with thrombolytic therapy compared with anticoagulation in acute pulmonary embolism, including the subset of hemodynamically stable patients with right ventricular dysfunction (intermediate-risk pulmonary embolism). PubMed, the Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from inception through April 10, 2014. Eligible studies were randomized clinical trials comparing thrombolytic therapy vs anticoagulant therapy in pulmonary embolism patients. Sixteen trials comprising 2115 individuals were identified. Eight trials comprising 1775 patients specified inclusion of patients with intermediate-risk pulmonary embolism. Two reviewers independently extracted trial-level data including number of patients, patient characteristics, duration of follow-up, and outcomes. The primary outcomes were all-cause mortality and major bleeding. Secondary outcomes were risk of recurrent embolism and intracranial hemorrhage (ICH). Peto odds ratio (OR) estimates and associated 95% CIs were calculated using a fixed-effects model. Use of thrombolytics was associated with lower all-cause mortality (OR, 0.53; 95% CI, 0.32-0.88; 2.17% [23/1061] vs 3.89% [41/1054] with anticoagulants; number needed to treat [NNT] = 59) and greater risks of major bleeding (OR, 2.73; 95% CI, 1.91-3.91; 9.24% [98/1061] vs 3.42% [36/1054]; number needed to harm [NNH] = 18) and ICH (OR, 4.63; 95% CI, 1.78-12.04; 1.46% [15/1024] vs 0.19% [2/1019]; NNH = 78). Major bleeding was not significantly increased in patients 65 years and younger (OR, 1.25; 95% CI, 0.50-3.14). Thrombolysis was associated with a lower risk of recurrent pulmonary embolism (OR, 0.40; 95% CI, 0.22-0.74; 1.17% [12/1024] vs 3.04% [31/1019]; NNT = 54). In intermediate-risk pulmonary embolism trials, thrombolysis was associated with lower mortality (OR, 0.48; 95% CI, 0.25-0.92) and more major bleeding events (OR, 3.19; 95% CI, 2.07-4.92). Among patients with pulmonary embolism, including those who were hemodynamically stable with right ventricular dysfunction, thrombolytic therapy was associated with lower rates of all-cause mortality and increased risks of major bleeding and ICH. However, findings may not apply to patients with pulmonary embolism who are hemodynamically stable without right ventricular dysfunction.