Archive for the ‘Aortic Valve: TAVR, TAVI vs Open Heart Surgery’ Category

Aortic Valve Transplant Via Carotid Artery at Hadassah – An Israel First

Curator and Reporter: Aviva Lev-Ari, PhD, RN

The transplant using the carotid artery as the point of entry was selected. The technique of trans-carotid access, Dr. Planer, Director of Hadassah’s Catheterization Department says, “is not performed in “the majority of medical centers worldwide.”

The Medical Case

A 76-year-old man with a history of critical stenosis of his aortic valve arrived at Hadassah Hospital Ein Kerem in severe cardiac shock. It was clear he needed a valve transplant urgently, but the traditional surgical options were not suitable for him because he also had severe vascular disease, anatomical limitations and had undergone previous heart bypass surgery.

Dr. Planer explains, “Until two decades ago, patients who required an aortic valve replacement had to have surgery that involved opening the chest. The recovery was long and difficult.”

This procedure, says Dr. Planer, “is performed using a hybrid approach, with catheterization specialists and cardiac surgeons.” Using this collaborative approach, Dr. Planer, Dr. Gabby Elbaz-Greener, senior catheterization specialist and head of the Structural Heart Intervention Program; Dr. Amit Korach, senior cardiac surgeon; Prof. Ronen Beeri, director of the Echocardiography Unit and senior anesthesiologist; and Dr. Tamer Abu Jreis, anesthesiology resident, successfully replaced the valve.

“Beyond choosing the right patient and the high technical capacity of the team, in a procedure such as this, it is of utmost importance for us to work harmoniously, despite coming from different disciplines,” says Dr. Planer. “Thankfully, the operation went smoothly and without complications. We are proud to be the first team in Israel to carry it out and pave the way for an additional therapeutic option for these seriously ill patients. Our patient has now been discharged to begin rehabilitation, and we wish him a full recovery.”


Transcarotid Compared With Other Alternative Access Routes for Transcatheter Aortic Valve Replacement

Originally publishedhttps://doi.org/10.1161/CIRCINTERVENTIONS.118.006388 Circulation: Cardiovascular Interventions. 2018;11:e006388




The optimal access for patients undergoing transcatheter aortic valve replacement (TAVR) who are not candidates for a transfemoral approach has not been elucidated. The purpose of this study was to compare the safety, feasibility, and early clinical outcomes of transcarotid TAVR compared with thoracic approaches.


Methods and Results

From a multicenter consecutive cohort of 329 alternative-access TAVR patients (2012–2017), we identified 101 patients who underwent transcarotid TAVR and 228 patients who underwent a transapical or transaortic TAVR. Preprocedural success and 30-day clinical outcomes were compared using multivariable propensity score analysis to account for between-group differences in baseline characteristics. All transcarotid cases were performed under general anesthesia, mainly using the left common carotid artery (97%). Propensity-matched groups had similar rates of 30-day all-cause mortality (2.1% versus 4.6%; P=0.37), stroke (2.1% versus 3.5%; P=0.67; transcarotid versus transapical/transaortic, respectively), new pacemaker implantation, and major vascular complications. Transcarotid TAVR was associated with significantly less new-onset atrial fibrillation (3.2% versus 19.0%; P=0.002), major or life-threatening bleeding (4.3% versus 19.9%; P=0.002), acute kidney injury (none versus 12.1%; P=0.002), and shorter median length of hospital stay (6 versus 8 days; P<0.001).



Transcarotid vascular access for TAVR is safe and feasible and is associated with encouraging short-term clinical outcomes. Our data suggest a clinical benefit of transcarotid TAVR with respect to atrial fibrillation, major bleeding, acute kidney injury, and length of stay compared with the more invasive transapical or transaortic strategies. Randomized studies are required to ascertain whether transcarotid TAVR yields equivalent results to other alternative vascular access routes.


This is the first report of a multicenter propensity score-matched comparison between transcarotid and transthoracic access. The main findings are (1) transcarotid TAVR is safe and feasible in appropriately selected patients with a high rate of device success (87%); (2) compared with transapical and transaortic TAVR, the transcarotid approach was associated with no significant difference in rates of 30-day all-cause mortality, stroke, new pacemaker implantation, major vascular complications, and hemodynamic performance; (3) transcarotid TAVR is associated with significantly less new-onset atrial fibrillation, acute kidney injury, major or life-threatening bleeding, and shorter hospital stay.

TAVR technology has evolved considerably in the last few years allowing for the treatment of 85% to 90% of patients via the transfemoral route.4,15,16 Until recently, the transapical and transaortic approaches were considered the main alternative nontransfemoral routes, with comparable short- and long-term outcomes.17–19 Despite their advantage of simplifying valve positioning, major surgical manipulation of the chest wall is required. Furthermore, these techniques are limited by relative contraindications, such as significant respiratory failure in case of transapical, and porcelain aorta, as well as previous heart surgery, in cases of transaortic. Transcarotid TAVR was first performed in France in 2009,20 and then was subsequently adopted by several other centers.7–9,21,22 These experiences demonstrated that the surgical approach to the carotid artery is safe and relatively uncomplicated because of its superficial location, and operative experience with the carotid arteries is widespread among cardiovascular surgeons. We prefer performing transcarotid TAVR using the left common carotid because it allows superior coaxial alignment of the THV with the aortic annulus, although both sides can be used.9,10,21

In the current study, the 30-day crude stroke or TIA rate in the transcarotid group was 3% (2 disabling and 1 nondisabling stroke), with no significant difference compared with the transapical/transaortic group (as previously described in smaller studies).10,11 This stroke rate is lower than that observed in the cohort of patients included in the multicenter French Transcarotid TAVR Registry and others.8,9 As previously described,8,21 these neurological events are not always localized ipsilateral to the CCA used for TAVR. This suggests that there are other phenomena at play in addition to carotid arterial manipulation, such as new-onset postprocedural atrial fibrillation, periprocedural hypotension, inadequate contralateral carotid perfusion, and the THV deployment itself. Although the rates of preimplant and postimplant balloon valvuloplasty were significantly higher in the transapical/transaortic group even after adjustment, this did not translate to a higher risk of stroke or TIA among the transapical/transaortic patients. The low rate of stroke observed in this study may be attributed to careful patient selection and the intraoperative assessment of the functional integrity of the circle of Willis as used in one center in this study, using indirect methods, such as backflow blood pressure during carotid clamping and cerebral oximetry monitoring.7 However, the optimal preprocedural evaluation and periprocedural neurological monitoring during transcarotid TAVR are yet to be determined. Also, the optimal antithrombotic regimen and the role of embolic protection devices23–25 require further study to determine efficacy in the reduction of the risk of cerebral ischemia, specifically in patients undergoing transcarotid TAVR as literature is scarce in these patients.

Other major findings of this study were that transcarotid TAVR was significantly associated with a reduction in major or life-threatening bleeding and shorter LOS, compared with transapical/transaortic TAVR. This could be explained by (1) less-invasive access site exposure in the case of transcarotid TAVR compared with a minithoracotomy or hemisternotomy in the transapical/transaortic approach; (2) less ventilator use and shorter intensive care unit stay in transcarotid TAVR10; and (3) less pain during the postprocedural recovery and earlier patient mobilization. The lower incidence of new-onset atrial fibrillation among transcarotid TAVR patients may also partly explain shorter LOS. Any incision of the thoracic cavity is associated with various forms of supraventricular arrhythmia, most commonly atrial fibrillation, which may then translate to a prolonged hospital stay.26,27 A reduction of LOS is a critical component of current strategies to control overall costs associated with TAVR and may be the primary driver of reduced expenditure associated with transfemoral TAVR compared with alternative-access TAVR.28–30 Furthermore, severe bleeding may be associated with postprocedural hypovolemia and may explain, in part, the reduction in the rates of severe acute kidney injury in transcarotid cases compared with the transapical/transaortic approach.31,32 Similar findings were previously reported when comparing transapical or transaortic with transfemoral access. Blackstone et al33 reported their results in 501 propensity score-matched patients undergoing transapical versus transfemoral TAVR. More patients in the transapical group experienced adverse procedural events, longer length of stay, slower recovery, and higher transfusion rates. Similar results were published by Arai et al,34 who reported significantly higher rates of life-threatening bleeding when comparing transaortic (n=289) with transfemoral TAVR (n=467; 6% versus 3%, respectively; P=0.021) without a significant difference in other major outcomes. Our data also suggest that the risk of major vascular complications are decreased with a transcarotid TAVR approach (matched analysis, 3.2% versus 10.7%; P=0.05), although the study was underpowered for this specific end point and did not reach statistical significance.

Postoperative echocardiographic data showed favorable results in both groups, as either access provides direct aortic annular access and may allow superior positioning in particular anatomies (Figure). The observed 30-day mortality in the adjusted analysis (2.1% versus 4.6%; P=0.37; transcarotid versus transapical/transaortic, respectively) was also statistically comparable between groups and lower than that previously reported in transcarotid TAVR cohorts.8,9


Study Limitations

This report consists of a retrospective analysis of prospectively acquired data and is subject to the limitations inherent in this study design. Selection of patients was not random and may not be generalizable to other centers. Other alternative approaches, such as the subclavian route, were not evaluated because of the limited number of patients undergoing TAVR by subclavian access at the participating centers. The superficial position of the carotid artery coupled with the more complex exposure of the subclavian and its proximity to the brachial plexus, and the risks associated with its use if an ipsilateral internal mammary artery was used as a coronary bypass graft, have lead us to favor transcarotid over the subclavian approach. As well, specific end points, such as mortality, stroke, and major vascular complications, may have not reached statistical significance because of the small sample size and short-term follow-up. However, this is the largest multicenter study evaluating the transcarotid approach using a risk-adjusted comparator arm. Small numbers did not permit us to ascertain device-specific outcomes. However, adjusting the analysis for type of THV, we found that the association between decreased major bleeding and the transcarotid approach was modulated, in part, by the use of newer valve types with their lower profile delivery systems but was not entirely explained by this feature of the newer THVs (Appendix in the Data Supplement). Taken further, this association may also be access site specific and not entirely device specific. Accessing proximal high-pressure structures, such the left ventricular apex and ascending aorta, may be associated with less ability to adequately control bleeding compared with distal arterial sites, such as the carotid artery. Device-specific features of the newer TAVR prostheses, such as improved sealing skirts, did not influence postprocedural aortic regurgitation, need for a permanent pacemaker, pressure gradients, and overall procedural success rates in our study, which were similar between the transcarotid and transapical/transaortic groups.

Periprocedural cerebral monitoring was variable among institutions during transcarotid TAVR, reflecting a lack of consensus in the literature, and the rates of neurological events may have been underestimated because systematic evaluation by magnetic resonance imaging was not routinely performed following TAVR. However, the incidence of stroke/TIA was low and did not differ among centers (Table VII in the Data Supplement); the optimal perioperative neuromonitoring technique remains to be prospectively elucidated. However, all clinically significant neurological changes were identified, and all sites had a low-threshold trigger for consultation by a neurologist and the performance of neuroimaging post-TAVR. Preprocedural and postprocedural antiplatelet and anticoagulation therapy were not consistently captured across the study centers, which may confound the association between the approaches studied and outcomes, such as bleeding, cerebrovascular events, and mortality. However, all centers stopped the second antiplatelet agent at least 48 hours before the procedure for patients undergoing transapical or transaortic TAVR. We, therefore, cannot attribute the increased bleeding rates associated with transapical/transaortic solely to preoperative double antiplatelet therapy.



Transcarotid vascular access for TAVR is safe, feasible, and associated with encouraging short-term clinical outcomes in terms of mortality, stroke, and major vascular complications in patients who are not candidates to transfemoral TAVR. Furthermore, the transcarotid approach was associated with lower rates of major or life-threatening bleeding, new-onset atrial fibrillation, acute kidney injury, and shorter LOS compared with transapical or transaortic access. Larger prospective studies with longer follow-up are needed to confirm the safety and clinical efficacy of transcarotid TAVR compared with alternative approaches.




Transcatheter Aortic Valve Replacement via the Transcarotid Access

The Best Alternative?
Originally published
Circulation: Cardiovascular Interventions. 2018;11:e007459

See Editorial by Chamandi et al


Figure. Comparative 30-day/in-hospital outcomes of different access routes for transcatheter aortic valve replacement ( TAVR) according to the VARC definitions.




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

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Volume Six: Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment. On com since 12/24/2018 https://lnkd.in/e_CTb4R


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TricValve Transcatheter Bicaval Valves System – Interventional cardiologists at Cleveland Clinic have successfully completed the first implantation in North America

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 7/22/2022

Cardiothoracic surgeons at UC San Francisco performed the first robotically assisted mitral valve prolapse surgery in San Francisco.

Reporter: Aviva Lev-Ari, PhD, RN



The Patient for this historic procedure:

An 82-year-old man presenting with severe symptomatic tricuspid regurgitation (TR) and right heart failure (RHF).

Expert Opinion: The Voice of Dr. Justin D. Pearlman, MD, PhD, FACC

The TricValve addresses the problem of severe ìncompetance of the tricuspid valve with a relatively simple procedure.

Instead of the challenge of replacing the defective valve, a catheter procedùre places valves at the two venous intake locations, the superior and ìnferior vena cava. A valve at the superior vena cava entrance to the right atrium occurs occasionally in nature, but is usually absent or fenestrated, covering the medial end if the crista supraventricularis.

A similar termed valve is occasionally found in nature on the inferior vena cava. These supernumerary valves can arrest back flow of pressure and volume from the right atrium to the upper and lower venous systems, and alleviate in particular congestion of the liver.

Normally the right atrial pressure is low, in which case this would offer no significant advantage for reproductive success natural selection to offset potential interference with blood flow into the right atrium that might promote thrombosis [Folia Morphology Morphology 66(4):303-6, MRuso].

However, in a setting of right heart failure, such as occurs from pulmonary hypertension, the tricuspid valve often becomes incompetent, and placement of the pair of vena cava valves can alleviate upstream consequences, albeit at the cost of risk of thrombosis and future impediment to other future procedures such as ablation of supraventricular arrhythmia.

The vena cava valves placed by catheter at the Cleveland Clinic helped an 80 year old man alleviate his pressing issue of hepatic congestion. Unlike a replacement tricuspid valve this procedure does not alleviate high pressures dilatìng the right atrium. Instead, it can worsen that problem.

The CLASP II TR trial is investigating the Edwards PASCAL transcatheter repair system [CLASP II TR, Edwards Lifesciences Corp, NIH NCT 0497145]

Survival data for surgìcal tricuspid valve replacements reported 37+-10 percent ten year survival, with average all cause survival of just 8.5 years [Z HIscan, Euro J CT Surgery 32(2) Aug 2007]. None-the‐less,  comparison of patients with vs without intervention for incompetance of the trìcuspid valve favored mechanical intervention [G Dreyfus Ann Thorac Surg 49:706-11,1990, D Adams, JACC 65:1931-8, 2015]. Time will tell which interventìon will prevail, and when these catheter alternatives to open chest surgery should be deployed.

The first implantation in North America: TricValve Transcatheter Bicaval Valves System

The structural heart procedure occurred in February 2022.

Rishi Puri, MD, PhD, an interventional cardiologist with Cleveland Clinic, and Samir Kapadia, MD, chair of cardiovascular medicine at Cleveland Clinic, performed the procedure. Puri has years of experience with the TricValve system, participating in a thorough analysis of its safety and effectiveness in 2021.

The TricValve system features two biological valves designed to be implanted via femoral vein access into the patient’s superior vena cava and inferior vena cava. This allows a therapy without impacting the patient’s native tricuspid valve. It is available in multiple sizes, allowing cardiologists to choose the best option for each individual patient.

Cleveland Clinic’s statement detailing the successful procedure notes that patients with severe TR and RHF have typically had limited treatment options. Tricuspid valve surgery is associated with significant risks, for instance, and prescribing diuretics is problematic when the patient also presents with kidney problems.

“TricValve can potentially provide an effective and low-risk solution for many patients who currently have no treatment options,” Puri said, adding that the workflow is quite similar to transcatheter aortic valve replacement.

The TricValve Transcatheter Bicaval Valves System was developed by P+F Products + Features GmbH, a healthcare technology company based out of Vienna, Austria. The solution was granted the FDA’s Breakthrough Device designation in December 2020, but it has still not gained full FDA approval.

This procedure was completed under a compassionate-use clearance from the FDA.

Image Source:


Related Structural Heart Disease Content:

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VIDEO: TAVR durability outperforms surgical valves

How the continued rise of TAVR has impacted SAVR outcomes

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Older LAAO patients, especially women, face a higher risk of complications




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

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 7/21/2022

VIDEO: TAVR’s long-term impact on patient care

Dave Fornell | June 23, 2022 | TAVR

We spoke with Azeem Latib, MD, section head and director of interventional cardiology and director of structural heart interventions for Montefiore Health System. Latib also served as a program director for the 2022 Transcatheter Valve Therapeutics (TVT) Structural Heart Summit.

In our chat, he summarized the key advances in transcatheter aortic valve replacements (TAVR) therapy and explained a key TAVR trend that came out of TVT for “lifetime patient management.”

It was clear at the meeting that the standard-of-care thinking on TAVR replacements has shifted from just getting a valve implanted and managing immediate complications to looking decades down the road and considering next steps with that same patient. TAVR now makes up about 70% or more of the procedure volume for aortic valve replacements. Latib said the focus of many sessions at TVT was on the longer-term management of valve patients since it is clear TAVR is becoming the standard of care. If a patient gets surgical or TAVR valve today, they will likely need a replacement in 10-20 years. More times than not, Latib explained, this replacement will come in the form of another TAVR valve deployed inside the first valve.

Latib said several sessions discussed what strategy is best, with many experts favoring surgical valve replacement first and two TAVR procedures later in life to eliminate the need for open heart surgery when the patient is much older and more frail. However, many experts admitted this might not be the strategy that gets adopted as a practical standard of care because most patients want the less invasive option versus surgery. 

“I think all the companies have realized that they need to move their technologies in that direction,” Latib explained. “The bar has been set really high and so we are going to see a lot of new technologies or iterations of technology.”

The Edwards Lifesciences Sapien X4, the forth generation of the Sapien valve, is about to start the ALLIANCE pivotal trial. It is designed specifically for lower-risk patients with a lower frame height for better coronary access and it is the first balloon-expandable valve that allows the operator to turn the valve to align the commissures, which also will aid further coronary access. The valve is also designed to reduce the need to use oversized valves to ensure a good fit in the anatomy

“What this means is when you do the next valve you are not going to have issues with coronary access and having a more physiologically aligned valve on the commissures made help the valve last longer,” Latib said. 

He said the Abbott Portico and Boston Scientific Acurate Neo2 TAVR systems are also undergoing revisions to make them more user friendly and compatible with the shifting needs of TAVR.

More resources:

VIDEO: What is needed to build a structural heart program — Interview with Charles Davidson, MD

VIDEO: TAVR durability outperforms surgical valves — Interview with Michael Reardon, MD

How the continued rise of TAVR has impacted SAVR outcomes

Is TAVR a sensible choice for patients with moderate, symptomatic aortic stenosis? Medtronic aims to find out

Left bundle branch block after TAVR hurts outcomes, even when no permanent pacemaker is required

Find more TAVR content

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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

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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.



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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 and Curator: 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.



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.


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.


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.


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).


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.


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



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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*




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.


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.


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.


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.”



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




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Post TAVR: Management of conduction disturbances and number of valve recapture and/or repositioning attempts – Optimize self-expanding transcatheter aortic valve replacement (TAVR) positioning reduced the need for permanent pacemaker (PPM) implants down the road

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 4/14/2021

Specialists complete first procedure in historic head-to-head TAVR study

A study with significant implications for the future of patient care is officially underway. Specialists at Penn Medicine in Philadelphia have reported completing the first procedure in a global head-to-head study comparing the safety and effectiveness of two leading transcatheter aortic valve replacement (TAVR) systems.

The Small Annuli Randomized to Evolut or Sapien (SMART) post-market trial is designed to compare the safety and effectiveness of self-expanding TAVR systems manufactured by Medtronic and balloon-expandable systems manufactured by Edwards Lifesciences when treating patients with small annuli. More than 90 different facilities are taking part in the trial, and approximately 700 patients with severe symptomatic aortic stenosis are expected to participate. A majority of study participants are expected to be women due to the trial’s focus on individuals with small annuli.

Howard C. Herrmann, MD, a professor of cardiovascular diseases at the University of Pennsylvania’s Perelman School of Medicine, is leading the trial.

“Penn Medicine has been in on the ground floor of many of the early and landmark trials in TAVR research since performing one of the first investigational procedures in 2007, and, since then, we have completed thousands of these procedures,” he said in a prepared statement. “Subsequently, multiple devices have been FDA approved, and the procedure has grown to become the predominant one for all patients with aortic stenosis. The outcome of this study will help cardiac teams to make more tailored decisions about which kind of valve to use on which patients.”

The SMART trial’s estimated primary completion date is May 2023. The estimated study completion date, meanwhile, is May 2028.

  • The PPM rate dropped from 9.7% to 3.0% (P=0.035), according to a team led by Hasan Jilaihawi, MD, of NYU Langone Health in New York City.
  • the PARTNER 3 and CoreValve Low Risk trials in patients at low surgical risk showed PPM implant rates of 17.4% with the Evolut line, 6.6% with the balloon-expandable Sapien 3, and 4.1%-6.1% with surgery.
  • “The His bundle passes through the membranous septum, a few millimeters beneath the non-coronary/right coronary cusps. It is therefore not surprising that a deeper valve implantation increases the likelihood of mechanical damage of the His bundle leading to a transient or persistent conduction disturbance,” according to Rodés-Cabau.

To capture factors that contributed to need for PPM implantation, Jilaihawi and colleagues performed a detailed restrospective analysis on 248 consecutive Evolut recipients at Langone treated with the standard TAVR approach — aiming for 3-4 mm implant depth (in relation to the non-coronary cusp) and recapturing and repositioning when the device landed considerably lower. Patients with prior PPM implantation were excluded. Devices used were Medtronic’s Evolut R, Evolut Pro, and Evolut 34XL.

This analysis revealed that use of the large Evolut 34XL (OR 4.96, 95% CI 1.68-14.63) and implant depth exceeding membranous septum length (OR 8.04, 95% CI 2.58-25.04) were independent predictors of later PPM implantation.

From there, operators came up with the MIDAS technique and applied it prospectively to another 100 consecutive patients.

Besides bringing down the PPM implant rate to 3.0%, there were no more cases of valve embolization, dislocation, or need for a second valve.

The standard and MIDAS groups shared similar membranous septum lengths but diverged in average actual device depth, such that the standard group tended to have Evolut devices positioned deeper (3.3 mm vs 2.3 mm, P<0.001).



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Mitralign and Corvia, Tewksbury, Mass – Investment and Acquisition by Edwards Lifesciences


Reporter: Aviva Lev-Ari, PhD, RN


Edwards LifesciencesEdwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets.

Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said.

“We are extremely pleased to have the support of the global leader in patient-focused innovations for structural heart disease as we continue to advance this novel treatment for heart failure,” Corvia president & CEO George Fazio said in prepared remarks. “We are proud of our accomplishments to date and look forward to completing the pivotal study with the support of our global clinical investigators.”

The Irvine, Calif.-based company also said it bought “certain” Mitralign assets, including intellectual property and associated clinical and regulatory experience. Mitralign, also based in Tewksbury, is developing an annuloplasty system for treating functional mitral and tricuspid regurgitation.

Edwards said the transactions are not expected to affect its financial outlook for 2019.



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Reporter: Gail S. Thornton

This article appeared on the website of Cardiovascular Business

‘Patient No. 1’ from a Hep C heart transplant study shares his story

By the time three transplant physicians approached Tom Giangiulio Jr. about being the first patient in a new clinical trial to accept a heart from a Hepatitis C-positive donor, Giangiulio didn’t have much of a choice.

He had already been on the heart transplant waitlist for more than two years, he was a live-in at the Hospital of the University of Pennsylvania and he had a body size (6-foot-2, 220 pounds) and blood type (O-positive) that was difficult to match to a donor.

It took Giangiulio less than 24 hours to speak to his previous cardiologist and his family and decide to enroll in the program. The doctors at Penn explained to him that because of new medications that can cure Hepatitis C, they were confident the virus could be eradicated post-transplant.

“There was no hesitation at all, not with me,” said Carin Giangiulio, Tom’s wife of 33 years. “Because I knew what the alternative was and we didn’t have too much choice except for going on a VAD (ventricular assist device) … and he didn’t want to do that. I said, ‘If they have a cure, then it’s a no-brainer. Let’s just do it.’ And I’m glad we did because I don’t think he would’ve been here today.”

Tom, 59, is set to celebrate his second anniversary with his new heart in June. He received the heart the day after Father’s Day in 2017 and subsequently contracted Hepatitis C, which was promptly wiped out with a 12-week regimen of elbasvir/grazoprevir (Zepatier).

Some of Giangiulio’s doctors at Penn published in February their experience with the first 10 patients in the clinical trial, called USHER, in the American Journal of Transplantation. All nine patients who survived were cured of Hepatitis C thanks to the antiviral therapy.

The implications of the research are massive, said Rhondalyn McLean, MD, MHS, the medical director of Penn’s heart transplant program and lead author of the recently published study. For the past two decades, the U.S. has struggled to increase the number of heart transplants above about 3,000 per year. And every year, patients die waiting for a heart transplant or become too sick to handle a transplant surgery.

McLean estimated 700 hearts from donors with Hepatitis C are discarded each year in the U.S. If even half of those are suitable for transplant, it would increase by 10 percent the number of organs that are available for implantation.

“There are so many people who have end-stage heart failure who die waiting for transplant, so anytime that we can increase our access to organs then I think we’re all going to be happy about that,” McLean said. “I think the people believe in the medicine, they believe that Hepatitis C is curable, so the risk to these folks is low. With the results of the study, I think we’ve proven that we can do this safely and the medications have great efficacy.”

Transplanting Hepatitis C-positive hearts isn’t a new idea, McLean explained.

“We used to do this all the time (with) the thinking that Hepatitis C usually doesn’t cause a problem for many, many years, so if hearts are only going to last 13 years or so and Hepatitis C doesn’t usually cause a problem for 30 years in someone, it should be an OK thing to do,” she said.

But then a study published in the 1990s found Hepatitis C-negative patients who accepted a heart from a donor with Hepatitis C actually had an increased risk of death compared to those who received normal hearts, and the practice of using these organs ceased.

However, with the new medications—the first commercially available treatment for Hepatitis C was approved by the FDA in 2014—McLean and her team are systematically studying the safety of implanting these hearts and then wiping out the virus once it’s contracted. And they’re optimistic about the program, which showed the first 10 patients had no evidence of the virus after their 12-week medication regimens.

“That met the criteria for sustained virologic response and those patients are deemed to be cured,” she said. “There’s no reason to think that this population would be any different than your normal, nontransplant population (in terms of Hepatitis C reappearing) so I think it was a pretty successful study.”

Penn researchers are also studying a similar approach in kidney and lung transplant candidates, which could help patients stuck on waitlists for those organs as well.

McLean described the increasing availability of these organs as an “unfortunate benefit” of the opioid epidemic. Through sharing needles, many opioid users are contracting Hepatitis C and dying young. Organs from young donors tend to perform better and often have no other problems, so solving the Hep C issue through medication could have a huge impact if this strategy is eventually rolled out on a broader scale.

“It’s hard when you have single-center studies,” McLean said. “They’re always promising, but in order to get a better assessment of what we’re doing and how the drug is doing I think you need to combine numbers so there has to be a registry that looks at all of the patients who have received these drugs and then using numbers to determine whether this is a successful strategy for us. And I believe that it will be.”

Those are the large-scale implications of this research. Tom Giangiulio can share the personal side.

Patient No. 1

Giangiulio said he feels “extremely gifted” to be Patient No. 1 in the USHER program. He knows he may not be alive if he wasn’t.

He recalls going into ventricular tachycardia about a week before his transplant and said it “scared the daylights” out of him.

“The amount of red tape, meetings and research, technology, and things that had to happen at a very precise moment in time for me to be the first … it’s mind-boggling to think about it,” he said. “But for all that to happen and for it to happen when it happened—and for me to get the heart when I got it—there was a lot of divine intervention along with a lot of people that were involved.”

Giangiulio has also experienced some powerful moments since receiving the transplant. After a bit of written correspondence with his donor’s family, he met the young man’s family one weekend in December of 2018.

He said riding over to the meeting was probably the most tense he’s ever been, but once he arrived the experience far exceeded his expectations.

“We were there for 2 ½ hours and nobody wanted to leave,” Giangiulio said.

The donor’s mother got Giangiulio a gift, a ceramic heart with a photograph of her son. A fellow transplant patient had told Giangiulio about a product called Enso, a kidney-shaped object you can hold in your hand which plays a recording of a user’s heartbeat.

Giangiulio decided to give it to her.

“I was very cautious at the advice of the people here at Penn,” he said. “Nobody knew how she would react to it. It might bother her, she could be thrilled to death. And she was, she was thrilled to death with it and she sleeps with it every night. She boots up the app and she listens to my heartbeat on that app every night.”

Another moment that sticks out to Giangiulio is meeting Patient No. 7 in the USHER program, who he remains in touch with. They ran into each other while waiting to get blood work done, and began talking about their shared experience as transplant recipients.

The clinical trial came up and Giangiulio slow-played his involvement, asking Patient No. 7 about the trial and not letting on that he was ultra-familiar with the program.

When Giangiulio finally told him he was Patient No. 1, Patient No. 7 “came launching out of his chair” to hug him.

“He said, ‘I owe you my life,’” Giangiulio recalled.

After Giangiulio responded that it was the doctors he really owed, Patient No. 7 said he had specifically asked how Patient No. 1 was doing when McLean first offered the program to him.

“She explained that I was going to be No. 7. … I didn’t care about 6, 5, 4, 3 or 2. I wanted to know how No. 1 was doing,” Giangiulio recalled of the conversation. “He said, ‘That was you. … They told me how well you were doing and that if I wanted you’d come here and talk to me, so I owe you.’”

Giangiulio feels strongly about giving back and reciprocating the good fortune he’s had. That’s why he talks to fellow patients and the media to share his story—because it could save other people’s lives, too.

He can’t do as much physical labor as he used to, but he remains involved in the excavating company he owns with his brothers and is the Emergency Management Coordinator for Waterford Township, New Jersey. He also serves on the township’s planning board and was previously Director of Public Safety.

“To me, he’s Superman,” Carin Giangiulio said. “It was insane, completely insane what the human body can endure and still survive.”

That now includes being given a heart with Hepatitis C and then wiping out the virus with the help of modern medicine.

“I would tell (other transplant candidates) to not fear it, especially if you’re here at Penn,” Giangiulio said. “I know there’s a lot of good hospitals across the country, but my loyalty kind of lies here for understandable reasons.”

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


People with blood type O have been reported to be protected from coronary heart disease, cancer, and have lower cholesterol levels.



A Patient’s Perspective: On Open Heart Surgery from Diagnosis and Intervention to Recovery


No evidence to change current transfusion practices for adults undergoing complex cardiac surgery: RECESS evaluated 1,098 cardiac surgery patients received red blood cell units stored for short or long periods



ACC/AHA Guidelines for Coronary Artery Bypass Graft Surgery


On Devices and On Algorithms: Arrhythmia after Cardiac SurgeryPrediction and ECG Prediction of Paroxysmal Atrial Fibrillation Onset



Editor’s note:

I wish to encourage the e-Reader of this Interview to consider reading and comparing the experiences of other Open Heart Surgery Patients, voicing their private-life episodes in the ER that are included in this recently published volume, The VOICES of Patients, Hospital CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures.



I also wish to encourage the e-Reader to consider, if interested, reviewing additional e-Books on Cardiovascular Diseases from the same Publisher, Leaders in Pharmaceutical Business Intelligence (LPBI) Group, on Amazon.com.

  • Perspectives on Nitric Oxide in Disease Mechanisms, on Amazon since 6/2/12013


  • Cardiovascular, Volume Two: Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation, on Amazon since 11/30/2015


  • Cardiovascular Diseases, Volume Three: Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics, on Amazon since 11/29/2015


  • Cardiovascular Diseases, Volume Four: Regenerative and Translational Medicine: The Therapeutics Promise for Cardiovascular Diseases, on Amazon since 12/26/2015


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