Posted in Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, PCI, Stents & Tools on June 8, 2015| Leave a Comment »
Reporter: Aviva Lev-Ari, PhD, RN
Stenting Provides Better Early Outcomes vs Angioplasty Alone for PAD TCTMD The reduction in amputation with stenting was observed across various high-risk subgroups, including elderly patients and those with acute or chronic limb ischemia, chronic…
Sourced through Scoop.it from: www.tctmd.com
See on Scoop.it – Cardiovascular and vascular imaging
Posted in Atrial Fibrilation (a-Fib), Cardiac Pacing and Arrhythmias, Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, PCI on May 19, 2015| Leave a Comment »
Reporter: Aviva Lev-Ari, PhD, RN
The researchers studied 50 patients before and after implantation of the MitraClip over 20 months. There were 68 sustained VT episodes in the patient prior to implantation, and 30 after. The number of long-lasting episodes (those with a cycle length of more than 300 milliseconds) recorded was 46 prior to implantation and 21 episodes following use of the MitraClip.
The number of non-significant VT episodes fell from 56 to 49 after implantation, a statistically insignificant difference.
Studies demonstrating efficacy of the MitraClip are crucial because the device got FDA’s approval in 2013 despite the results from its pivotal trial, which found that MitraClip posted almost no clinical benefits over traditional valve surgery after four years.
On top of this study comparing the device to ICDs, experts at the annual meeting of the American College of Cardiology said post market registry data collected on the MitraClip shows that the device is safe and effective, for the primary clinical benefit of a reduction in mitral regurgitation was achieved in 63.7% of patients.
The MitraClip is meant to treat mitral regurgitation, which is associated with ventricular tachyarrhythmia. Mitral regurgitation involves a leaky heart valve that lets blood flow backward and can cause irregular heartbeats, stroke or heart failure. MitraClip is delivered via catheter through the femoral vein in the leg, and it clips together parts of the mitral valve. The solution is meant to be less invasive than regular surgery.
“The market opportunity for mitral regurgitation is significant but still in its early stages, and MitraClip is the only product on the market to-date that can treat this disease in a minimally invasive way,” said Abbott CEO Miles White during its most recent earnings call.
He said sales of the device increased at a double-digit rate in both the U.S. and abroad.
– read the study
– here’s MassDevice‘s take
Related Articles:
Registry data shows Abbott’s MitraClip transcatheter valve is performing well in real-world settings
Abbott wins Medicare coverage, new tech add-on payments for MitraClip cardiology device
Abbott’s MitraClip heart valve device gains FDA’s long-awaited blessing
Four year results: Abbott’s MitraClip no better than surgery
SOURCE
Posted in Cardiac and Cardiovascular Surgical Procedures, FDA, PCI on April 16, 2015| Leave a Comment »
Reporter: Aviva Lev-Ari, PhD, RN
SILVER SPRING, MD — The Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted 9 to 2, with one member abstaining, that the injectable antiplatelet agent cangrelor (the Medicines Company, Parsippany, NJ) should be approved for reducing thrombotic events in PCI—a reversal from the committee’s vote last year.
Today’s “yes” votes included acting chair Dr Philip Sager (Stanford University School of Medicine, CA). He told heartwire from Medscape after the meeting there was “a lot of good discussion,” and he was impressed that the sponsor responded several times with additional data when asked.
“Everyone was committed to making this a good meeting. And I’d say in the end that the data, taken in totality, showed that cangrelor will have an important role in the armamentarium for a subset of patients undergoing PCI,” said Sager.
Some of the “good discussion” he mentioned sounded more like hearty debate as questions and concerns were brought up throughout the day regarding the trial at the center of the new drug application. CHAMPION-PHOENIX showed positive results in its cangrelor-vs-clopidogrel comparison. However, the previousCHAMPION-PLATFORM and CHAMPION-PCI trials were both negative.
Last year, the committee voted 7 to 2 against recommending cangrelor for PCI because of data problems and they felt that the risk/benefit profile was not sufficiently strong enough. The Medicines Company then underwent further sensitivity analyses and supplied a more simplified application.
Earlier this week, FDA reviewers gave a favorable review that the agent now be approved “in patients in whom treatment with an oral P2Y12 platelet inhibitor prior to PCI is not feasible and when glycoprotein IIb/IIIa receptor antagonists are not anticipated to be used.” They also noted that PHOENIX was sufficient enough as a stand-alone trial to warrant approval of cangrelor[1].
However, several panel members voiced concerns both last year and this year that PHOENIX was successful only after the failure of the other two trials. “Is this a pivotal trial or just a third attempt?” asked Dr Scott Emerson (University of Washington, Seattle). “If we don’t like the results, can we just fish through essentially the same population to get a better efficacy point?”
Emerson, along with Dr Julia Lewis (Vanderbilt University School of Medicine, Nashville, TN), cast the two “no” votes today. Lewis also voiced her displeasure with looking only at PHOENIX. “I have a lot of concerns that make me unwilling to accept a single trial for approval,” she said.
The one abstaining vote came from Dr Thomas Fleming (University of Washington, Seattle). “Specifically in this case, it felt more comfortable to abstain because there are issues on both sides of this,” he explained.
Even several of the “yes” voters did so after asking many, many questions throughout the day about the study and treatment procedures, population, and especially the statistical data. Still, the bottom line is that the majority of the committee voted its approval for the medication.
“I think it was important that these different sensitivity analyses were done and that more conservative approaches were statistically examined. It showed that there really is a clinically meaningful benefit of using cangrelor as compared with clopidogrel the way it was administered in the study,” said Sager.
Reference
FDA Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC)
Meeting Date: 15 April 2015
NDA: 204958
Sponsor: The Medicines Company
Drug: KENGREAL (cangrelor) for Injection Proposed Indication KENGREAL is an intravenous P2Y12 platelet inhibitor indicated for for Use: reduction of thrombotic cardiovascular events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI – PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable (P2Y12 is a protein involved in blood clotting. Inhibiting this protein is a key mechanism of action of cangrelor). Title of Study: PHOENIX – A randomized, double-blind, parallel group, superiority study comparing cangrelor to clopidogrel in subjects who require PCI.
The primary objective was to demonstrate that cangrelor reduces the risk of a composite of all-cause mortality, myocardial infarction, ischemia driven revascularization, and stent thrombosis compared to clopidogrel.
Posted in Cardiac and Cardiovascular Surgical Procedures, PCI on February 24, 2015| Leave a Comment »
Reporter: Aviva Lev-Ari, PhD, RN
Anderson SG, Ratib K, Myint PK, et al.Impact of age on access site related outcomes in 469,983 percutaneous coronary intervention procedures: Insights from the British Cardiovascular Intervention Society. Catheter Cardiovasc Interv. 2015; DOI:10.1002/ccd.25896. Abstract
Impact of age on access site related outcomes in 469,983 percutaneous coronary intervention procedures; insights from the British Cardiovascular Intervention Society
DOI: 10.1002/ccd.25896
Copyright © 2015 Wiley Periodicals, Inc., a Wiley company
Objective
We investigate adoption of the TRA in different age groups and study the relationship between age and access site related outcomes in a national cohort of patients undergoing PCI in the UK.
Background
Previous studies have reported conflicting data on radial access site adoption between different age groups, with age an independent predictor of failure of procedures undertaken through the radial approach.
Methods
Age and access site related outcomes (based on transradial (TRA) and transfemoral (TFA) access) were studied in 469,983 PCI procedures undertaken in the UK from 2006-2012 in the age groups; <60, 60-<70, 70-<80 and ≥80 in the British Cardiovascular Intervention Society database.
Results
We studied access site practice in 469,983 patients who underwent PCI procedures in the United Kingdom. TRA utilization increased from 17.5%to 65.6% in the age group <60, and 16.6% to 54.5% in the age group ≥80 between 2006-2012. TRA was independently associated with decreased 30 day mortality in all age groups (<60: OR 0.64; 95% CI 0.54-0.74, P<0.0001; 60 to <70: OR 0.65; 95% CI 0.57-75, P<0.0001,70 to <80: OR 0.58 (0.52-0.65, P<0.0001 and ≥80: OR 0.65 (0.57-0.73, P<0.0001).
Conclusions
Adoption of the TRA for PCI has occurred least in older patients in the UK despite similar associations between TRA use and decreased 30-day mortality observed in all age groups. This article is protected by copyright. All rights reserved.
Posted in Acute Myocardial Infarction, Cardiomyopathy, Frontiers in Cardiology and Cardiovascular Disorders, PCI on December 11, 2014| Leave a Comment »
Magnetic resonance imaging of microvascular obstruction in hypertrophic obstructive cardiomyopathy after percutaneous transluminal septal myocardial ablation
Reporter: Aviva Lev-Ari, PhD, RN
The aim of this study is to assess the relationship between the location of MO and the improvement in symptoms and pressure gradient after percutaneous transluminal septal myocardial ablation (PTSMA) in patients with HOCM. The location of MO identified by MRI may be related to the effectiveness of PTSMA at the short–term follow–up. The left–sided MO is related to complete improvement in clinical symptoms and pressure gradients.
SOURCE
Acta Radiologica
Source: www.mdlinx.com
Posted in Cardiac and Cardiovascular Surgical Procedures, PCI on November 7, 2014| Leave a Comment »
Reporter: Aviva Lev-Ari
Original Study
Iqbal MB, Ilsley C, Kabir T, et al. Culprit vessel versus multivessel intervention at the time of primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction and multivessel disease. Circ Cardiovasc Qual Outcomes 2014; DOI:10.1161/circoutcomes.114.001194. Abstract
LONDON, UK — A real-world analysis of ST-segment-elevation MI (STEMI) patients undergoing primary PCI has shown that treating the culprit lesion only is associated with a lower rate of in-hospital major adverse cardiovascular events (MACE) and lower mortality at 30 days and 1 year compared with individuals who undergo a more comprehensive multivessel intervention[1].
For those undergoing culprit-lesion primary PCI, the in-hospital MACE, 30-day mortality, and 1-year mortality rates were 4.6%, 4.7%, and 7.4%, respectively, whereas the corresponding event rates were 7.2%, 7.7%, and 10.1% for patients undergoing multivessel PCI. These differences were statistically significant and support the current European practice guidelines that recommend culprit-lesion PCI in STEMI patients, according to the researchers.
The results, which are published November 4, 2014 inCirculation: Cardiovascular Quality and Outcomes, contrast with the recent findings from the Complete Versus Lesion-Only Primary PCI Trial (CVLPRIT). As reported by heartwire when the results were presented at the European Society of Cardiology 2014 Congress, CVLPRIT compared an infarct-related artery revascularization strategy against complete revascularization at the time of index admission and showed the more comprehensive approach significantly reduced the risk of MACE at 1 year.
Similarly, the Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) study also showed treating nonculprit lesions in STEMI patients resulted in a significant 65% relative reduction in the MACE risk, a reduction driven by decreases in nonfatal MI and refractory angina.
Speaking with heartwire , Dr Bilal Iqbal (Royal Brompton and Harefield NHS Foundation Trust, Middlesex, UK), the lead investigator of the newest analysis, said both PRAMI and CVLPRIT were excellent studies but pointed out that the end points in those trials were composite end points. In CVLPRIT, the primary MACE end point included all-cause mortality, recurrent MI, heart failure, and repeat revascularizations. In PRAMI, the primary end point included death from cardiac causes, nonfatal MI, and refractory angina.
“The end points that they use in their study are very different from the end point we have used,” said Iqbal. “We looked at mortality, which is a hard end point. If you look at PRAMI and CVLPRIT, they have composite end points, which include death, MI, and more important, include end points like refractory angina and ischemia-driven revascularization. These events can be dictated by the treatment strategy. For example, if you’re not going to be treating bystander coronary disease then you are going to be getting refractory angina. You are going to have ischemia-driven revascularization.”
In PRAMI and CVLPRIT, when all-cause mortality was assessed as an individual end point, there was no difference between culprit-lesion and multivessel coronary revascularization. Iqbal also noted that the CVLPRIT study compared complete revascularization prior to hospital discharge, whereas their analysis compared only culprit- vs multivessel interventions at the time of the index intervention.
“There are differences between all these studies, and it does make it very difficult to compare and generalize,” said Iqbal.
The London Analysis
For their analysis, Iqbal and his collaborators, all of whom are part of the London Heart Attack Center Group, included 3984 STEMI patients with multivessel disease undergoing primary PCI at eight tertiary cardiac centers in London, UK. Of these, 3429 patients underwent culprit-lesion revascularization and 555 patients were treated with complete revascularization.
In their analysis, culprit-lesion PCI was associated with lower mortality at 30 days and 1 year. For in-hospital outcomes, treating the culprit lesion resulted only in lower in-hospital MACE, a reduction that was driven by significant reductions in reinfarction, reintervention, and mortality. In a multivariate-adjusted model, culprit-lesion PCI was an independent predictor of death at 30 days (hazard ratio 0.45;P<0.001) and 1 year (hazard ratio 0.65; P=0.011). For the in-hospital outcomes, culprit-lesion PCI was an independent predictor of MACE, as well as in-hospital reinfarction and in-hospital mortality.
In a propensity-matched analysis adjusted for differences in demographics and clinical, anatomic, and procedural variables, the results were consistent with the overall findings.
To heartwire , Iqbal said their study is a registry study, but the results are in line with other registry analyses showing that culprit-vessel revascularization at the time of the index intervention is associated with better outcomes. He pointed out that despite adjustments to their risk models, registry studies are subject to potential confounding, which is one of the drawbacks. He suggests their results should be viewed as hypothesis generating.
“CVLPRIT and PRAMI have certainly provided a lot of evidence in the treatment of multivessel disease in the context of STEMI, but there are more trials under way, particularly the COMPLETE trial,” said Iqbal. “PRAMI and CVLPRIT, those are randomized trials — those are hard data — but we still need to wait for other trials to come in so we can refine our treatment strategy for these patients.”
Officially known as the Complete vs Culprit-Only Revascularization to Treat Multi-vessel Disease After Primary PCI for STEMI, the COMPLETE study is being led by researchers at the Population Health Research Institute out of McMaster University in Ontario. The investigators plan to enroll approximately 4000 patients, and full results are expected in 2018.
SOURCE
http://www.medscape.com/viewarticle/834510?nlid=69312_1984&src=wnl_edit_medn_card&uac=93761AJ&spon=2
Posted in Atherogenic Processes & Pathology, Cardiac and Cardiovascular Surgical Procedures, Cerebrovascular and Neurodegenerative Diseases, Innovations in Neurophysiology & Neuropsychology, PCI on October 15, 2014| Leave a Comment »
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 8/5/2018
Takeaway
Why this matters
Key results
Study design
Limitations
SOURCE
UPDATED on 7/17/2016
Significant bleeding risk may outweigh any benefit
PERSONAL NOTE
In August 2007, I shadowed KAI U. FRERICHS, MD, performing interventional procedures at the Stroke and Cerebrovascular Center which is part of the Institute for the Neurosciences at Brigham and Women’s Hospital
KAI U. FRERICHS, MD, an endovascular neurosurgeon, uses leading multimodality approaches for cerebrovascular disease treatment, including coil embolization of cerebral aneurysms, intra-arterial interventions for clot thrombolysis and removal in acute stroke, carotid and intracranial stenting and angioplasty, and cerebral and spinal AVM. Dr. Frerichs’ research focus includes the development of novel neuroprotective strategies for stroke and neurotrauma.
http://www.brighamandwomens.org/Departments_and_Services/neurology/services/stroke/default.aspx
STUDY CONCLUSIONS by the German government report
SOURCE
www.iqwig.de — Institute for Quality and Efficiency in Health Care, Germany
Address of publisher:
Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany
Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: http://www.iqwig.de
IQWiG Reports – Commission No. N14-01
Stents for the treatment of intracranial artery stenosis1
2014-10-09
The risk of having another stroke is higher if patients, after dilation of their blood vessels in the brain, not only receive clot-inhibiting drugs, but also have small tubes called stents inserted. However, studies have provided no hint of a benefit from stenting, which is also referred to with the abbreviation “PTAS”. This is the conclusion reached in the rapid report of the German Institute for Quality and Efficiency in Health Care (IQWiG), as published on 9 October 2014.
Blood vessels in the brain that are narrowed or blocked can cause stroke. If patients have already had a stroke or temporary ischaemia (transient ischaemic attack, TIA), there is a high risk that this occurs again. These patients therefore receive drugs that prevent blood clotting. Another option is to additionally widen the narrowed vessels.
Nowadays this is often done using a small balloon in a procedure known as percutaneous transluminal angioplasty (PTA). But even after PTA and simultaneous blood-thinning medication, vessels often remain narrow (stenosis) or new narrowing occurs (restenosis). The treatment has therefore been expanded to include stenting (percutaneous transluminal angioplasty and stenting, PTAS): Small wire mesh tubes are inserted to support the widened blood vessels and prevent restenosis. This stenting has been available for approximately 10 years.
The Federal Joint Committee (G-BA) had commissioned IQWiG to assess the benefit of PTASfor patients with symptoms of narrowed blood vessels in the brain (symptomatic intracranial stenosis). PTAS was to be compared with drug treatment with blood-thinning medications alone and with balloon dilatation without stenting (PTA). Like PTAS, PTA always involves administration of blood-thinning drugs.
IQWiG identified a total of four randomized controlled trials (RCTs) that included patients with symptomatic intracranial stenosis. In three studies, PTAS was compared with drug treatment alone. One study tested PTAS versus PTA.
The SAMMPRIS study was relevant for the assessment of PTAS in comparison with drug treatment alone. SAMMPRIS included a total of 451 participants and is the largest study currently available. It is also the only study to provide data both on mortality and side effects and on stroke in all areas of the brain.
The two other studies (Miao 2012 and Gao 2013) only reported strokes that occurred in the territory of the treated vessels. However, it is relevant for the patients whether strokes occur at all – irrespective of their localization. Hence only data from the SAMMPRIS study were available for the outcome “stroke” as well.
Besides mortality (all-cause mortality and from stroke), the burden of disease in the form of stroke, TIA, and other physical or psychological impairments from ischaemia, the patient-relevant outcomes of this assessment also include side effects (e.g. bleeding events or myocardial infarction) and dependence on others or requiring care. However, these were not fully reported in any of the studies. None of the four studies provided results on further criteria that are important for patients such as health-related quality of life, hospitalization or physical endurance.
As the SAMMPRIS data showed, a new stroke is considerably more common in patients who have received an intracranial stent than in patients who only received medication: This was the case in 59 participants (26.3%) in the PTAS group, and in only 42 participants (18.5%) in the comparator group.
Differentiated by type of stroke, these differences can be determined in haemorrhagic stroke, i.e. stroke caused by bleeding, but not in ischaemic stroke, which is caused by narrowing. The haemorrhagic strokes were often periprocedural events occurring within 30 days of the intervention. In many cases, these strokes were apparently caused by mechanical manipulation during the placement of the stent.
These disadvantages are not accompanied by advantages in other outcomes: There was no relevant difference between the treatment groups in mortality (all-cause mortality and cerebrovascular mortality). The IQWiG report came to the same conclusion with regard to repeated revascularization, i.e. the necessity to widen narrowed vessels again.
All the studies included by IQWiG were subject to uncertainty and their results might be biased. The main reasons were unclear issues regarding randomization and the premature unplanned termination of the studies.
This is also true for SAMMPRIS, which started in November 2008, but was ended prematurely in April 2011 because considerably more events (counting deaths and strokes) had occurred in the PTAS group. Even though this decision is comprehensible, the results can be biased because of the premature termination of the study.
Despite the uncertainty described, IQWiG overall considers there to be a hint of harm fromPTAS in comparison with drug treatment alone.
The interpretation of the SAMMPRIS results was made more difficult because the drugs were not used according to the specifications in the Summary of Product Characteristics valid in Germany: The patients in both groups received a combination of two clot-inhibiting drugs, acetylsalicylic acid (ASA) and clopidogrel (dual antiplatelet therapy). This combination is used in Germany, but is not approved for stroke because it is known to increase the risk of bleeding. It can also not be excluded that there is an interaction between the drugs and stent placement (PTAS), which particularly might influence the occurrence of bleeding.
PTAS is another example that high-quality studies are needed for risk class III medical devices, which also include stents: In the United States, intracranial stents had at first been approved for treatment of a specific, relatively small group of fewer than 4000 patients affected. This approval was based on case series and on the Humanitarian Device Exemption. However, Medicare, an American health insurance for elderly and disabled people, then demanded anRCT as prerequisite for its reimbursement of stents.
So the SAMMPRIS study, funded by the National Institutes of Health, was initiated. Only thisRCT, i.e. a study with a higher level of evidence, revealed that more strokes occurred under the new, allegedly innovative Treatment.
This confirmed the conclusion already drawn in the case of antibody-coated stents inserted in coronary vessels: Not only the medical device is decisive, but also its manner of application. “The entire application including its accompanying factors has to be investigated, and not only the stents themselves, to obtain reliable knowledge about the benefit stents have for patients”, concludes Stefan Sauerland, Head of the IQWiG Department of Non-Drug Interventions.
The Federal Joint Committee (G-BA) commissioned IQWiG on 28 February 2014 to prepare the report in an accelerated process, known as a “rapid report”. Unlike the normal procedure, no preliminary reports are published in this case. Although a draft version of the report is reviewed by external experts, no hearing at which all interested parties can comment takes place. The report (version 1.0) was sent to the commissioning agency on 11 September.
An overview of the background, methods and further results of the report is provided in the following executive summary.
Posted in Cardiac and Cardiovascular Surgical Procedures, PCI on October 10, 2014| Leave a Comment »
Angioplasty.Org
FFR and iFR: Roadmapping Your Heart, With Traffic
Angioplasty.Org
The angiogram may show a narrowing, but that narrowing may not be causing a reduced flow of blood to the heart, a.k.a.
Source: www.ptca.org
See on Scoop.it – Cardiovascular and vascular imaging
UPDATED on 10/10/2016
Reporter: Aviva Lev-Ari, PhD, RN
2012pharmaceutical
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