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Archive for the ‘Cardiac and Cardiovascular Surgical Procedures’ Category

Breakthrough Procedure in Aortic Valve Repair: VIDEO: How to Perform a Transcaval TAVR Procedure

Reporter: Aviva Lev-Ari, PhD, RN

VIEW VIDEO

https://www.dicardiology.com/videos/video-how-perform-transcaval-tavr-procedure

Tiberio Frisoli, M.D., interventional structural cardiologist, senior staff physician, Henry Ford Hospital, explains how his center performs transcaval transcatheter aortic valve replacement (TAVR) access for patients who have suboptimal abdominal aortic and femoral vascular anatomy. Transcaval access was pioneered at Henry Ford Hospital and involves using femoral vein access and then using a surgical radio frequency cutter to bore a hole from the interior venacava into the aorta to allow the TAVR delivery catheter to path through. 

This procedure was developed to enable more patients to receive TAVR via the preferred femoral access route. Some patients are not candidates for femoral artery access because of calcified lesions and heart atherosclerotic plaque, which narrows the vessel lumen, and makes it difficult to thread catheters through. The transcaval access technique can bypass the restricted arteries or heavy calcified plaques to still enable a minimally invasive procedure without the need for surgery. 

This video was produced in partnership from Henry Ford Hospital.

Related Transcaval TAVR Content:

VIDEO: Transcaval Access in TAVR Procedures — Interview with Adam Greenbaum, M.D.

How to Perform Transcaval TAVR Access

VIDEO: Walk Through of the Henry Ford Hospital Structural Heart Cath Lab

Study Deems Transcaval Valve Replacement Pioneered at Henry Ford Hospital Successful

First Transcaval Aortic Valve Replacement Performed in Europe

Additional articles and videos on Henry Ford Hospital 

Find more structural heart technology content

SOURCE

https://www.dicardiology.com/videos/video-how-perform-transcaval-tavr-procedure

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CentraCare First in World to Use 4D Hologram Technology to Successfully Complete Structural Heart Procedure

Reporter: Aviva Lev-Ari, PhD, RN

Published Jun 23, 2021 in Heart & Vascular, Media ReleasesAuthor: CentraCare

EchoPixel’s Pre-Planning and Intra-Operative Technologies

EchoPixel’s pre-planning and intra-operative technologies reduced complex heart procedure time while improving quality of outcomes

CentraCare, one of the largest health systems in Minnesota, has successfully completed the first structural heart procedure in the world using 4D hologram technology, which was developed by EchoPixel. Jacob Dutcher, MD, an interventional cardiologist and director of the structural heart program at CentraCare Heart & Vascular Center, conducted the WATCHMAN implant, which is a one-time, minimally invasive procedure for people with atrial fibrillation who need an alternative to blood thinners to protect them from a stroke. Approximately six million people in the U.S. suffer from atrial fibrillation and many of them are intolerant to blood thinners.

This new approach to the WATCHMAN procedure combines both EchoPixel’s pre-planning True3D software with its intra-operative Holographic Therapy Guidance (HTG) software platform. By leveraging mixed reality capabilities, EchoPixel brings precision to structural heart procedures by utilizing HTG, a transformative 4D technology that enables the entire heart team to interact with a patient’s specific organs and tissues as if they were actual, physical objects. These technologies reduce procedure time, improve accuracy of the procedure, reduce risk of complication and hasten recovery.

CentraCare Heart & Vascular Center is the first in the world to use EchoPixel’s technology both before and during a structural heart procedure. “EchoPixel pre-planning True3D software helped us reduce our procedure times by more than 27% and increase optimal procedure outcome by 20%. EchoPixel-HTG is taking us to the next level,” says Dr. Dutcher. “As one of the world’s largest WATCHMAN implanting sites, we are always looking for new ways to advance and improve patient care, and are proud to be the first center in the world to offer this novel imaging technology.”

“Dr. Dutcher has been very influential in the development and evolution of our HTG technology,” says Sergio Aguirre, CEO of EchoPixel. “Having him on board has helped us hone our device and approach as we draw on his vast experience with this procedure. We are looking forward to continuing to work with him and CentraCare to adapt our software to other structural heart procedures, providing an even greater benefit to patients.”

About CentraCare Heart & Vascular Center

CentraCare Heart & Vascular Center is one of the largest cardiovascular programs in Minnesota, offering the latest advancements in care, technology and treatment. In 2020 U.S. News & World Report rated the program as #41 in the nation for cardiology and heart surgery. It is part of CentraCare, a Minnesota health system that includes eight hospitals in St. Cloud, Long Prairie, Melrose, Monticello, Paynesville, Redwood Falls, Sauk Centre and Willmar. The health system also owns more than 30 clinics along with 18 senior housing facilities and long-term care facilities throughout the region. Learn more about CentraCare Heart & Vascular Center

About EchoPixel

Headquartered in Silicon Valley, EchoPixel is a venture capital-backed startup and a pioneer in creating the operating room of the future. The company’s technologies include the first pre-operative True3D planning platform and intra-operative Holographic Therapy Guidance (HTC) software, which allow physicians to interact with patient-specific organs and tissues as if they were actual, physical objects. EchoPixel’s True3D software platform has already become the standard of care at world-leading congenital heart defect and structural heart centers. Learn more at echopixeltech.com.

Media Contacts:

Birgit Johnston, EchoPixel
birgitjohnston@me.com

SOURCE

https://www.centracare.com/blog/2021/june/centracare-first-in-world-to-use-4d-hologram-tec/

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Cardiac Surgery Recommendations Switch to Patient Blood Management

— Four societies outline pre- to post-op strategies to improve outcomes

by Crystal Phend, Contributing Editor, MedPage Today June 30, 2021

Reporter: Aviva Lev-Ari, PhD, RN

STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management

Published:June 30, 2021 DOI:https://doi.org/10.1016/j.athoracsur.2021.03.033

Switching from “blood conservation” to the broader “patient blood management” (PBM) approach is probably the biggest change, Tibi told MedPage Today.

“Basically we’re considering blood as another vital organ,” he said. “Why that is important is because now we look at a patient’s blood system as an organ that needs to be assessed and treated for the sake of that organ and not simply to decide when or when not to transfuse.”

Recommendations span the entire spectrum from preoperative assessment of bleeding risk and anemia to intraoperative perfusion and blood salvage practices to postoperative treatment with human albumin for volume replacement.

“Most hospitals around the U.S. are acutely aware of patient blood management and, to some degree or another, are implementing many of the things we are talking about,” noted Tibi, who is immediate past president of SABM. Nationwide, the amount of blood transfused in cardiac surgery has dropped 45% in the past 10 to 15 years but still ranges widely from center to center.

SOURCE

https://www.annalsthoracicsurgery.org/article/S0003-4975(21)00556-7/fulltext

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Application of Natural Language Processing (NLP) on ~1MM cases of semi-structured echocardiogram reports: Identification of aortic stenosis (AS) cases – Accuracy comparison to administrative diagnosis codes (IDC 9/10 codes)

Reporter: Aviva Lev-Ari, PhD, RN

Large-Scale Identification of Aortic Stenosis and its Severity Using Natural Language Processing on Electronic Health Records

Background Systematic case identification is critical to improving population health, but widely used diagnosis code-based approaches for conditions like valvular heart disease are inaccurate and lack specificity. Objective To develop and validate natural language processing (NLP) algorithms to identify aortic stenosis (AS) cases and associated parameters from semi-structured echocardiogram reports and compare its accuracy to administrative diagnosis codes. Methods Using 1,003 physician-adjudicated echocardiogram reports from Kaiser Permanente Northern California, a large, integrated healthcare system (>4.5 million members), NLP algorithms were developed and validated to achieve positive and negative predictive values >95% for identifying AS and associated echocardiographic parameters. Final NLP algorithms were applied to all adult echocardiography reports performed between 2008-2018, and compared to ICD-9/10 diagnosis code-based definitions for AS found from 14 days before to six months after the procedure date. Results A total of 927,884 eligible echocardiograms were identified during the study period among 519,967 patients. Application of the final NLP algorithm classified 104,090 (11.2%) echocardiograms with any AS (mean age 75.2 years, 52% women), with only 67,297 (64.6%) having a diagnosis code for AS between 14 days before and up to six months after the associated echocardiogram. Among those without associated diagnosis codes, 19% of patients had hemodynamically significant AS (i.e., greater than mild disease). Conclusion A validated NLP algorithm applied to a systemwide echocardiography database was substantially more accurate than diagnosis codes for identifying AS. Leveraging machine learning-based approaches on unstructured EHR data can facilitate more effective individual and population management than using administrative data alone.

Large-scale identification of aortic stenosis and its severity using natural language processing on electronic health records

Author links open overlay panel

Matthew D.SolomonMD, PhD∗†GraceTabadaMPH∗AmandaAllen∗Sue HeeSungMPH∗Alan S.GoMD∗‡§‖

Division of Research, Kaiser Permanente Northern California, Oakland, California

Department of Cardiology, Kaiser Oakland Medical Center, Oakland, California

Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, California

§

Departments of Epidemiology, Biostatistics and Medicine, University of California, San Francisco, San Francisco, California

Department of Medicine, Stanford University, Stanford, California

Available online 18 March 2021.

https://www.sciencedirect.com/science/article/pii/S2666693621000256

Background

Systematic case identification is critical to improving population health, but widely used diagnosis code–based approaches for conditions like valvular heart disease are inaccurate and lack specificity.

Objective

To develop and validate natural language processing (NLP) algorithms to identify aortic stenosis (AS) cases and associated parameters from semi-structured echocardiogram reports and compare their accuracy to administrative diagnosis codes.

Methods

Using 1003 physician-adjudicated echocardiogram reports from Kaiser Permanente Northern California, a large, integrated healthcare system (>4.5 million members), NLP algorithms were developed and validated to achieve positive and negative predictive values > 95% for identifying AS and associated echocardiographic parameters. Final NLP algorithms were applied to all adult echocardiography reports performed between 2008 and 2018 and compared to ICD-9/10 diagnosis code–based definitions for AS found from 14 days before to 6 months after the procedure date.

Results

A total of 927,884 eligible echocardiograms were identified during the study period among 519,967 patients. Application of the final NLP algorithm classified 104,090 (11.2%) echocardiograms with any AS (mean age 75.2 years, 52% women), with only 67,297 (64.6%) having a diagnosis code for AS between 14 days before and up to 6 months after the associated echocardiogram. Among those without associated diagnosis codes, 19% of patients had hemodynamically significant AS (ie, greater than mild disease).

Conclusion

A validated NLP algorithm applied to a systemwide echocardiography database was substantially more accurate than diagnosis codes for identifying AS. Leveraging machine learning–based approaches on unstructured electronic health record data can facilitate more effective individual and population management than using administrative data alone.

Keywords

Aortic stenosis Echocardiography Machine learning Population health Quality and outcomes Valvular heart disease

SOURCE

https://www.sciencedirect.com/science/article/pii/S2666693621000256

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Medical Device Representatives coach Surgeons in the Operating Rooms

Reporter: Aviva Lev-Ari, PhD, RN
Medical Device Representatives: The Untold Story

What Reps Don’t Do

As a surgeon and a healthcare executive, I’ve learned that the best device representatives are defined by what they won’t do: push a physician to use their product when it’s inappropriate. Villa says she sometimes sees patients who have blood clots in their arteries. “I will never recommend our product when there’s a clot because you can do more harm than good,” she says. “Ultimately, it’s up to the doctor’s discretion, but I’ll come right out and tell them, ‘I don’t know if CSI is the right product for that.’”

Just like physicians, device sales representatives have reputations to protect. A physician will recommend a helpful and knowledgeable sales representative to a colleague; but if the sales representative is clearly only interested in their bottom line — as opposed to the patient’s well-being — they’ll soon find that their calls go unanswered. For this reason, Nasser says he often finds himself advising physicians that his product isn’t appropriate for a patient. “You might not get the case,” he says, “but you’ll earn the trust of the physician.”

There’s a second — and more important — explanation for why these device representatives won’t push their products to boost sales. Simply put, that’s not why they’re in business. Nasser, for example, got into device sales after his father died of a heart attack. “I approach every case as if that were my family member and I ask what would be best for them,” he says.

“You can’t fake the passion and the caring you have,” adds Staub. “People see through if it’s just a business transaction.” Instead, he attributes his longevity to “engaging physicians in an educational way and getting across that you can be a partner in the care of their patients.”

When asked why she does her job, Villa thinks about the 77-year old woman she helped the day she drove to the hospital early in the morning. When the woman’s foot, which initially had turned grey, started to turn pink after the procedure, Villa says she was overcome with “a wonderful feeling. That patient had a fear of losing her limb and woke up knowing that her leg was still there. Saving limbs and saving lives. That’s the beauty of our job.”

¹ O’Connor B, Pollner F, Fugh-Berman A (2016) Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLoS ONE 11(8): e0158510. https://doi.org/10.1371/journal.pone.0158510

² White, T. Stanford Medicine Magazine, 2006, Fall Issue. Father of invention – Stanford Medicine Magazine – Stanford University School of Medicine

³ Gawande, A. The New Yorker, October 3, 2011. The Coach in the Operating Room | The New Yorker

 

SOURCE

 

https://www.cardiovascularbusiness.com/sponsored/2052/medical-device-representatives-untold-story

From: Cardiovascular Business <announcements@mail.cardiovascularbusiness.com>

Reply-To: Cardiovascular Business <announcements@mail.cardiovascularbusiness.com>

Date: Monday, March 1, 2021 at 10:30 AM

To: “Aviva Lev-Ari, PhD, RN” <AvivaLev-Ari@alum.berkeley.edu>

Subject: The Untold Story of Medical Device Reps: A Physician’s Perspective

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Bioresorbable Stent Clinical Trials with New Esprit Below-the-knee Scaffold

Reporter: Irina Robu, PhD

Abbott announced on September 3, 2020, the beginning of the LIFE-BTK clinical trial to evaluate effectiveness and safety of  the Esprit BTK Everolimus Eluting Resorbable Scaffold System. The Esprit BTK System consists of a thin strutted scaffold made of poly-L-lactide, a semi-crystalline bioresorbable polymer engineered to resist vessel recoil and provide a platform for drug delivery. The scaffold is coated with poly-D, L-lactide (PDLLA) and the cytostatic drug, everolimus.

This trial is the first Investigational Device Exemption in the US to assess a fully bioresorbable stent to treat blocked arteries below the knees, also known as critical limb ischemia in people battling advanced stages of peripheral artery disease. For people with CLI, blocked vessels weaken blood flow to the lower extremities, which can lead to severe pain, wounds, and in severe cases, limb amputation.

At this time, the standard of care for patients battling critical limb ischemia is balloon angioplasty, which depend on on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. Yet, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many cases the vessels become blocked again, lacking additional treatment.

Patients treated with balloon angioplasty often require several procedures on treated arteries, and  a drug eluting resorbable device is if at all possible suited to provide mechanical support, decrease the chance of the vessel re-narrowing and then slowly disappear over time. At this time, there are no drug eluding stents, drug coated balloons or bare metal stents approved for use below the knee. Since, there is a limited number of options for stents below the knee, the FDA has granted Esprit BTK breakthrough device designation, which simplifies review and pre-market approval timelines.

According to Abbott, Espirit BTK System is not a permanent implant, but it does provide support to an artery right after a balloon angioplasty, stopping the vessel from reclosing. As soon as it is implanted, the scaffold distributes a drug over a few months that encourages healing and keeps the artery open. The scaffold is naturally resorbed into the body over time, like dissolving sutures, and eventually leaves only a healed artery behind.

The LIFE-BTK trial is the first Investigational Device Exemption trial in the U.S. to evaluate a fully dissoluble device to treat critical limb ischemia in people battling advanced stages of peripheral artery disease (PAD). The trial will be run by principal investigators Brian DeRubertis, M.D. (vascular surgeon, UCLA), Sahil Parikh M.D., (interventional cardiologist, New York-Presbyterian/Columbia University Irving Medical Center.

SOURCE

https://www.dicardiology.com/article/abbott-restarts-bioresorbable-stent-clinical-trials-new-esprit-below-knee-scaffold

 

 

 

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Targeting Atherosclerotic Plaques with Stents made of Drug-eluting Biomaterials

Reporter: Daniel Menzin, BSc BioMedical Engineering, expected, May 2021, Research Assistant 4, Core Applications Developer and Acting CTO 

 

Atherosclerosis is a chronic cardiovascular disease with a multitude of different implications. A coronary artery plaque may lead to congestive heart failure while an aortic plaque may cause angina. Both can quite possibly lead to a heart attack unless properly managed. One way to manage this condition is through the use of stents made of a mesh that is expanded following placement into the diseased vessel.

Unfortunately, stents are oftentimes initially effective but eventually restenosis occurs. Restenosis is a condition in which the affected vessel becomes blocked again. Cholesterol-rich blood vessel environments oftentimes lead to an irritation that results in white blood cells aggregating in the area and releasing proinflammatory chemokines and cytokines, which cause fibrosis. To make matters worse, the cholesterol plaques undergo compression against the vessel wall which causes vessel injury and further inflammation. This leads to thrombus formation and may potentiate neointimal hyperplasia, an abnormal proliferation and migration of smooth muscle cells in the tunica intima. Neointimal hyperplasia plays a major role in restenosis.

Recent research has found that interfacing drug eluting biomaterials with stents may help prevent restenosis. One study showed that rapamycin delivered with acid labile and ROS-sensitive forms of Beta-cyclodextrin produced promising results when treating atherosclerosis in rat models (Dou, et al). In this promising new paradigm of treatment, non-proinflammatory biomaterials are interfaced with stents. Once inflammation appears the biomaterial will begin to degrade, slowly releasing the drug which suppresses the underlying immune reaction and the resulting inflammation.

 

SOURCE

Dou Y;Chen Y;Zhang X;Xu X;Chen Y;Guo J;Zhang D;Wang R;Li X;Zhang J; “Non-Proinflammatory and Responsive Nanoplatforms for Targeted Treatment of Atherosclerosis.” Biomaterials, U.S. National Library of Medicine, 29 July 2017, pubmed.ncbi.nlm.nih.gov/28778000/.

 

Other related articles published in this Open Access Online Scientific Journal include: 

75 articles found in the search 

https://pharmaceuticalintelligence.com/?s=drug+eluting+stents

 

Among them:

Stent Design and Thrombosis:  Bifurcation Intervention, Drug Eluting Stents (DES) and Biodegrable Stents

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/06/stent-design-and-thrombosis-bifurcation-intervention-drug-eluting-stents-des-and-biodegrable-stents/

 

Drug Eluting Stents: On MIT‘s Edelman Lab’s Contributions to Vascular Biology and its Pioneering Research on DES

Author: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/25/contributions-to-vascular-biology/

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Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement

Reporter: Aviva Lev-Ari, PhD, RN

Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

 

January 29, 2020
DOI: 10.1056/NEJMoa1910555

List of authors.

  • Raj R. Makkar, M.D.,
  • Vinod H. Thourani, M.D.,
  • Michael J. Mack, M.D.,
  • Susheel K. Kodali, M.D.,
  • Samir Kapadia, M.D.,
  • John G. Webb, M.D.,
  • Sung-Han Yoon, M.D.,
  • Alfredo Trento, M.D.,
  • Lars G. Svensson, M.D., Ph.D.,
  • Howard C. Herrmann, M.D.,
  • Wilson Y. Szeto, M.D.,
  • D. Craig Miller, M.D.,
  • et al.,

for the PARTNER 2 Investigators*

 

Abstract

BACKGROUND

There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.

METHODS

We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.

RESULTS

At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P=0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.

CONCLUSIONS

Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313. opens in new tab.)

 

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Comparison between balloon-expandable (Sapien XT or Sapien 3 valve, Edwards Lifesciences) vs self-expanding (CoreValve, Medtronic) TAVR from 2013 to 2015, Results: Lower mortality rate and other advantages with balloon-expandable valves over self-expanding valves.

Reporter: Aviva Lev-Ari, PhD, RN

 

French Studies Point to Inherent Differences in TAVR Valves

FRANCE-TAVI database was funded and managed by the French Society of Cardiology and French Working Group of Interventional Cardiology. Edwards Lifesciences and Medtronic partly funded the registry, but had no role in data collection, analysis, or manuscript drafting. Van Belle, Dehara, Abdel-Wahab, and Thiele report no relevant conflicts of interest.

Circulation. Published online November 16, 2019. AbstractAbstractEditorial

American Heart Association (AHA) Scientific Sessions 2019; presented November 16, 2019.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.

Patrice Wendling

November 25, 2019

The coprimary end point of at least moderate paravalvular regurgitation (PVR) at discharge and/or in-hospital mortality was more common with a self-expanding (SE) valve than with a balloon-expandable (BE) valve (19.8% vs 11.9%; relative risk [RR], 1.68). This related to nearly twofold more PVR (15.5% vs 8.3%; RR, 1.90) and a 1.4% absolute mortality difference (5.6% vs 4.2%; RR, 1.33).

Need for a permanent pacemaker (22.3% vs 11.0%; P < .0001) and a second transcatheter heart valve (3.7% vs 1.0%; P < .0001) was more frequent with SE valves.

Patients receiving an SE valve also had higher rates of myocardial infarction (0.4% vs 0.2%; P = .02) but had a lower mean transprosthetic gradient than those receiving a BE valve (7 vs 10; P < .0001).

At 2 years, use of a self-expanding valve was associated with a higher risk for all-cause mortality (29.8% vs 26.6%; hazard ratio, 1.17; 95% CI, 1.06 – 1.28) and cardiovascular death (23.3% vs 20.9%; P = .001). This is explained by a 36% excess risk for death during the first 3 months (= .0001), with the two mortality curves remaining parallel thereafter, Van Belle said.

The findings were consistent across subgroups, although the difference in the primary composite end point was stronger for those who received transfemoral TAVR and for those treated at the end of the study in 2015.

On multivariable analysis, independent predictors of all-cause mortality were valve design and PVR severity, according to the study, simultaneously published online in Circulation.

Limitations include the use of observational data, potential unmeasured residual confounders, site-reported PVR grading and clinical events (except mortality), and a lack of newer valve designs, Van Belle said.

“The present study strongly supports conducting a randomized trial in order to compare head-to-head the most recent iterations of SE and BE THVs on all-cause mortality,” he concluded.

The study, he said, “points out, if nothing else, that perhaps there is an inherent difference between the TAVR valves. It may be incorrect to assume it is a class effect.”

A second propensity-matched analysis, also published online in Circulation but not presented at AHA, used the nationwide French administrative hospital-discharge database to compare 10,459 matched pairs who underwent TAVR with the balloon-expandable Sapien 3 or self-expanding Evolut R (Medtronic) valve from 2014 to 2018.

Over a mean follow-up of 358 days, use of the BE vs the SE valve was associated with a lower yearly incidence of all-cause death (rate ratio, 0.88; corrected P = .005), cardiovascular death (rate ratio, 0.82; corrected P = .002), and rehospitalization for heart failure (rate ratio, 0.84; corrected P < .0001).

Pacemaker implantation was also lower with the balloon-expandable valve (rate ratio, 0.72; corrected < .0001), Pierre Deharo, MD, PhD, CHU Timone, Marseille, France, and colleagues report.

In an editorial accompanying the two analyses, Mohamed Abdel-Wahab, MD, and Holger Thiele, MD, both with the Heart Center Leipzig at the University of Leipzig, Germany, praised the authors for reporting what is currently the largest published dataset comparing the two valve designs. The limitations of registry-based analyses, however, are “obvious, and the findings should therefore be considered thought-provoking but by no means definite.”

SOURCE

https://www.medscape.com/viewarticle/921791?nlid=132763_3866&src=WNL_mdplsfeat_191126_mscpedit_card&uac=93761AJ&spon=2&impID=2182575&faf=1

Other related articles published in this Open Access Online Scientific Journal include the following 73 articles:

https://pharmaceuticalintelligence.com/?s=TAVR

 

 

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Risks from Dual Antiplatelet Therapy (DAPT) may be reduced by Genotyping Guidance of Cardiac Patients

Reporter: Aviva Lev-Ari, PhD, RN

 

Genotyping Cardiac Patients May Reduce Risks From DAPT

-STEMI patient study reaches noninferiority mark for adverse cardiac events

In the investigational arm, all 1,242 patients were tested for CYP2C19 loss-of-function alleles *2 or *3. Carriers received ticagrelor or prasugrel, while noncarriers received clopidogrel, considered to be less powerful.

No genetic testing was performed in the standard treatment arm (n=1,246), in which patients largely went on to receive ticagrelor or prasugrel. Nearly all patients in both cohorts received dual antiplatelet therapy (DAPT) with aspirin.

Following primary PCI, patients went on to the P2Y12 inhibitor for at least 12 months, with drug adherence similar between the genotype-guided (84.5%) and standard groups (82.0%).

For patients with CYP2C19 loss-of-function alleles in the genotype-guided arm, 38% received ticagrelor and 1% received prasugrel. The remaining 61% of patients — the noncarriers — received clopidogrel. In the control arm, 91% were treated with ticagrelor, 2% with prasugrel, and 7% with clopidogrel, according to local protocol.

Ten Berg said that prasugrel is not typically used in the Netherlands, where eight of the centers in the trial were located, but that this might change given that the drug lowered rates of ischemic events versus ticagrelor in the head-to-head ISAR REACT 5 trial, which was also presented at ESC.

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

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