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Posts Tagged ‘Heart valve’


First case in the US: Valve-in-Valve (Aortic and  Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices

Writer: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 9/24/2018

TCT: Long-Term Data Reassuring for Valve-in-Valve TAVR

New valve performs well through 3 years

by Nicole Lou, Contributing Writer, MedPage Today

Transcatheter valve-in-valve replacement had lasting benefits in a high-risk patient population requiring valve reintervention, registry data showed.

Starting with 365 patients who got valve-in-valve transcatheter aortic valve replacement (TAVR), death took its toll in 12.1%, 22.2%, and 32.7% by 12, 24, and 36 months, respectively. Stroke and repeat valve replacement had plateaued to 5.1% and 0.6% over 24 months, rising to 6.2% and 1.9% at the 36-month mark.

Valve performance was sustained the whole time, as effective orifice area had a significant boost from baseline to discharge, staying stable thereafter out to 3 years; mean gradient dropped after the procedure and similarly stayed unchanged over time, according to John Webb, MD, of St. Paul’s Hospital in Vancouver, at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Among survivors, early improvements in functional status were also maintained over the 3-year period, Webb said. Most patients started off in New York Heart Association class 3 and 4 and were reclassified as class 1 and 2 after TAVR. Quality of life also was better, as shown in improved Kansas City Cardiomyopathy Questionnaire overall summary scores: 43.1 at baseline to 70.8 at 30 days (P<0.0001), and staying stable out to 3 years.

The results were not influenced by surgical valve size, failure mode, approach, or residual gradient.

These data are “certainly reassuring out 2-3 years” but the concern lies in anticipation of lower-risk and younger patients who are expected to start getting TAVR in the future, commented Stephan Windecker, MD, of the University of Bern in Switzerland, who was a panelist at the TCT late-breaker trial session.

There are some concerns regarding coronary obstruction, Webb acknowledged. “This is true in surgical valves and it would be every bit as true in transcatheter valves, if not more so.”

Primary Source

Transcatheter Cardiovascular Therapeutics

Source Reference: Webb JG “Late follow-up from the PARTNER aortic valve-in-valve registry” TCT 2018.

SOURCE

https://www.medpagetoday.com/meetingcoverage/tct/75261?xid=nl_mpt_ACC_Reporter_2018-09-23&eun=g5099207d2r

 

UPDATED on 4/13/2014

Replacement of the Mitral Valve: Using the Edwards’ Sapien Aortic Valve Device

https://pharmaceuticalintelligence.com/2014/04/10/replacement-of-the-mitral-valve-using-the-edwards-sapien-aortic-valve-device/

 

 

June 23, 2013

The following is a report of the first case in the US of both aortic and mitral valve transcatheter replacements using transfemoral devices via the transapical approach. 

It is part of a series on the cardiovascular team at the Columbia Univarsity Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation in the Partner trial.

Concomitant Transcatheter Aortic and  Mitral Valve-in-Valve Replacements Using Transfemoral Devices Via the Transapical Approach

Paradis J-M, Kodali SK, Hahn RT, George I, Daneault B, et al.
ColumbiaUniversityMedicalCenter/NewYork-Presbyterian Hospital, New York, NY fJACC:CARDIOVASCULARINTERVENTIONS  2013;6(1):94-96
http://dx.doi.org/10.1016/j.jcin.2012.07.018

Case Presentation

This is an 85 year old man with congestive heart failure (CHF) NYHA class III/IV and hemolytic anemia. He had a previous history of S. viridans bacterial endocarditis that caused severe aortic and mitral regurgitations. Both aortic and mitral valves were replaced in 2002.  A recenttTransesophageal echocardiogram (TEE) showed the left ventricular ejection fraction (LVEF) was 55%.    This was related to severe mitral regurgitation caused by a flail leaflet, and its internal diameters measured 21-23.8 mm.  There was, in addition, severe stenosis of the Carpentir-Edwards valve in the aortic position with an aortic valve area (AVA) of only 0.9 cm, which was 24 mm internal diameter measured by 3-D TEE.

Action Taken

The patient was felt to require reoperative aortic and mitral valve replacements, but he was deemed inoperable by 2 cardiothoracic surgeons.  Therefore they decided to proceed with transapical transcatheter double valve-in-valve implantation using 2 commercially available RetroFlex 3 transfemoral devices (Edwards Lifesciences, Irvine, CA).  A 26-mm Edwards SAPIEN transcatheter heart valve (THV) was placed within the Carpentier-Edwards valve in the aortic position without pre-dilatation under rapid ventricular pacing.  An Edwards SAPIEN 26-mm THV was then deployed within the Hancock modified bioprosthesis in the mitral position with a 2-step inflation technique.  TEE after deplonment of both valves showed excellent function.  The new aortic prosthetic valve had an AVA of 2.08 cm, peak and mean gradients of 12 and 6 mm Hg, respectively, and no aortic insufficiency.  The mitral valve area was 1.65 cm, and there was only trace mitral regurgitation.

Figure 1.TEE Showing the Mitral Bioprosthetic Valve

Transesophageal echocardiogram (TEE) demonstrating (A) color Doppler through the mitral bioprosthetic  valve. Severe intraprosthetic  mitral regurgitation caused by a flail leaflet generates an eccentric regurgitant jet (see Online Video1).The effective regurgitant orifice was calculated  to be 0.42cm. (B) Measurements of the internal dimensions of the mitral bioprosthesis using 3-dimensional reconstruction imaging.

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

Figure 2.TEE Showing  the Aortic Bioprosthetic Valve.

Transesophageal echocardiogram (TEE) showing (A) planimetry of the orifice and (B) measurement of the internal diameter of the aortic bioprosthesis.

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

Figure 3.The 4 Prosthetic Heart Valves.

Final fluoroscopic images showing the 4 prosthetic heart valves (Hancock modified,Carpentier-Edwards, and 2 Edwards SAPIEN transcatheter heart valves) in different angulations

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

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Biomaterials Technology: Models of Tissue Engineering for Reperfusion and Implantable Devices for Revascularization

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Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems

Justin Pearlman MD ME PhD MA FACC, Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

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This image was selected as a picture of the we...

This image was selected as a picture of the week on the Farsi Wikipedia for the 46th week, 2010. (Photo credit: Wikipedia)

legend for transesophageal echocardiogram of m...

legend for transesophageal echocardiogram of mitral valve prolapse (Photo credit: Wikipedia)

Diagram of the human heart 1. Superior Vena Ca...

Diagram of the human heart 1. Superior Vena Cava 2. Pulmonary Artery 3. Pulmonary Vein 4. Mitral Valve 5. Aortic Valve 6. Left Ventricle 7. Right Ventricle 8. Left Atrium 9. Right Atrium 10. Aorta 11. Pulmonary Valve 12. Tricuspid Valve 13. Inferior Vena Cava (Photo credit: Wikipedia)

An artificial heart valve may be used to surgi...

An artificial heart valve may be used to surgically replace a patient’s damaged valve. (Photo credit: Wikipedia)

Mitral valve prolapse 2

Mitral valve prolapse 2 (Photo credit: Wikipedia)

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Treatment for Infective Endocarditis

Curator: Larry H Bernstein, MD, FACP

UPDATED on 3/4/2019

WATCH VIDEO

https://consultqd.clevelandclinic.org/tricuspid-valve-reconstruction-for-infective-endocarditis-operative-highlights-video/amp/?__twitter_impression=true

Tricuspid Valve Reconstruction for Infective Endocarditis: Operative Highlights (Video)

There are no easy solutions for acute infective tricuspid valve endocarditis in IV drug users, as the risk of prosthetic endocarditis in this population is high. Complete valve resection without replacement is feasible but leads to progressive right-sided heart failure. Reconstruction of the tricuspid valve with autologous pericardium is an alternative option, as demonstrated in the video case study below.

A 29-year-old female drug abuser with fever, hemoptysis and MRSA bacteremia was started on IV antibiotics. She looked frail and had prominent jugular venous pressure as well as 95 percent saturation on 2 liters of nasal cannula oxygen. She was not on inotropes and had a pulmonary artery pressure of 40/20 mmHg with a good cardiac index. Chest CT showed a large left pleural effusion with associated atelectasis of the left lung. The right lung had manifestations of septic emboli and a smaller pleural effusion.

A Cleveland Clinic surgical team led by cardiothoracic surgeon Faisal Bakaeen, MD, proceeded to excise the patient’s extensive infected and devitalized tissue around the tricuspid valve, leaving only a portion of the anterior leaflet to serve as a reference for reconstruction using autologous pericardium. Dr. Bakaeen walks us through the essential surgical steps — and their underlying rationale — in the narrated operative video below.

SOURCE

https://consultqd.clevelandclinic.org/tricuspid-valve-reconstruction-for-infective-endocarditis-operative-highlights-video/amp/?__twitter_impression=true

 

An article that appeared in NEJM compares early surgery versus conventional treatment for infective endocarditis.
Early Surgery versus Conventional Treatment for Infective Endocarditis
Duk-Hyun Kang, Yong-Jin Kim, Sung-Han Kim, Byung Joo Sun, et al.

N Engl J Med June 28, 2012; 366:2466-2473. http://doi.org/10.1056/NEJMoa1112843

Background and Purpose: While current guidelines advocate surgical management for complicated left-sided infective endocarditis and early surgery for patients with infective endocarditis and congestive heart failure, the indications for surgical intervention to prevent systemic embolism remain unclear. Surgery is favored by experience with complete excision of infected tissue and valve repair, and low operative mortality, but it does not remove concerns about residual active infection, which results in two sets of guidelines, the 2006 ACC-AHA for class IIa indication only for recurrent emboli and persistent vegetation, and the 2009 ESC guidelines for class IIb indication for very large, isolated vegetations. The Early Surgery versus Conventional Treatment in Infective Endocarditis (EASE) trial was conducted to determine whether early surgical intervention woulddecrease rate of death or embolic events.

Patient Enrollment: The study enrolled 76 consecutive patients, 18 years of age or older, with left-sided, native-valve infective endocarditis and a high risk of embolism. For all patients with suspected infective endocarditis, blood cultures were obtained and transthoracic echocardiography was performed within 24 hours after hospitalization. Patients were only eligible for enrollment if they had received a diagnosis of definite infective endocarditis and had severe mitral valve or aortic valve disease and vegetation with a diameter greater than 10 mm. Patients were excluded if they had moderate-to-severe congestive heart failure, infective endocarditis complicated by heart block, annular or aortic abscess, destructive penetrating lesions requiring urgent surgery, or fungal endocarditis, or were over 80 years age, or coexisting major embolic stroke with a risk of hemorrhagic transformation at the time of diagnosis, and a serious coexisting condition. Patients were also excluded if they had infective endocarditis involving a prosthetic valve, right-sided vegetations, or small vegetations (diameter, ≤10 mm) or had been referred from another hospital more than 7 days after the diagnosis of infective endocarditis.
The protocol specified that patients who were assigned to the early-surgery group should undergo surgery within 48 hours after randomization. Patients assigned to the conventional-treatment group were treated according to the AHA guidelines, and surgery was performed only if complications requiring urgent surgery developed during medical treatment or if symptoms persisted after the completion of antibiotic therapy. Details of the study procedures are provided in the Supplementary Appendix, available at NEJM.org.

Study End Points: The primary end point was a composite of in-hospital death or clinical embolic events that occurred within 6 weeks after randomization. An embolic event was defined as a systemic embolism fulfilling both prespecified criteria: the acute onset of clinical symptoms or signs of embolism and the occurrence of new lesions, as confirmed by follow-up imaging studies. Prespecified secondary end points, at 6 months of follow-up, included death from any cause, embolic events, recurrence of infective endocarditis, and repeat hospitalization due to the development of congestive heart failure.

Clinical and Echocardiographic Characteristics of the Patients at Baseline, According to Treatment Group:

The mean age of the patients was 47 years, and 67% were men. The mitral valve was involved in 45 patients, the aortic valve in 22, and both valves in 9. Severe mitral regurgitation was observed in 45 patients, severe aortic regurgitation in 23, severe aortic stenosis in 3, severe mitral regurgitation and stenosis in 1, and both severe mitral regurgitation and aortic regurgitation in 4. The median diameter of vegetation was 12 mm (interquartile range, 11 to 17). All patients met the Duke criteria for definite endocarditis; the most common pathogens in both groups were viridans streptococci (in 30% of all patients), other streptococci (in 30%), and Staphylococcus aureus (in 11%). Characteristics of Antibiotic Therapy, According to Treatment Group: There were no significant between-group differences in terms of control of the underlying infection, the antibiotic regimen used, or the duration of antibiotic therapy.

Surgical Procedures: All patients in the early-surgery group underwent valve surgery within 48 hours after randomization; the median time between randomization and surgery was 24 hours (interquartile range, 7 to 45). Of the 22 patients with involvement of the mitral valve, 8 patients underwent mitral-valve repair and 14 underwent mitral-valve replacement with a mechanical valve. Of the 15 patients with involvement of the aortic valve or both the mitral and aortic valves, 14 underwent mechanical-valve replacement and 1 underwent valve replacement with a biologic prosthesis. Concomitant coronary-artery bypass grafting at the time of valve surgery was performed in 2 patients (5%).

Conventional Therapy: Of the 39 patients assigned to the conventional-treatment group, 30 (77%) underwent surgery during the initial hospitalization (27 patients) or during follow-up (3). The surgical procedures included 11 mitral-valve repairs, 6 mitral-valve replacements (with 5 patients receiving a mechanical valve and 1 a biologic prosthesis), 11 aortic-valve replacements (with 9 patients receiving a mechanical valve and 2 a biologic prosthesis), and 2 combined aortic-valve replacements (with 1 patient receiving a mechanical valve and 1 a biologic prosthesis) and mitral-valve repairs. In 8 patients (21%), indications for urgent surgery developed during hospitalization (median time to surgery after randomization, 6.5 days [interquartile range, 6 to 10]). Elective surgery was performed in an additional 22 patients owing to symptoms or left ventricular dysfunction more than 2 weeks after randomization. Surgical results are shown in the Supplementary Appendix.

Primary End Point: The primary end point of in-hospital death or embolic events within the first 6 weeks after randomization occurred in one patient (3%) in the early-surgery group, as compared with nine (23%) in the conventional-treatment group (hazard ratio, 0.10; 95% confidence interval [CI], 0.01 to 0.82; P=0.03). In the early-surgery group, one patient died in the hospital and no patients had embolic events; in the conventional-treatment group, one patient died in the hospital and eight patients had embolic events (Table 3TABLE 3).
http://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/2012/nejm_2012.366.issue-26/nejmoa1112843/production/images/small/nejmoa1112843_t3.gif

At 6 weeks after randomization, the rate of embolism was 0% in the early-surgery group, as compared with 21% in the conventional-treatment group (P=0.005). No patient in either group had an embolic event or was hospitalized for congestive heart failure during follow-up. Recurrence of infective endocarditis within 6 months after discharge was not observed in any patient in the early-surgery group but was reported in 1 patient in the conventional-treatment group. Among the 11 patients (28%) in the conventional-treatment group who were treated medically and discharged without undergoing surgery, 1 (3%) died suddenly, 7 (18%) had symptoms related to severe valve disease or recurrence of infective endocarditis (3 of whom underwent surgery during follow-up), and 3 (8%) had no symptoms or embolic events (Table S3 in the Supplementary Appendix).
There was no significant difference between the early-surgery and conventional-treatment groups in all-cause mortality at 6 months (3% and 5%, respectively; hazard ratio, 0.51; 95% CI, 0.05 to 5.66; P=0.59) (Figure 2AFIGURE 2).
http://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/2012/nejm_2012.366.issue-26/nejmoa1112843/production/images/small/nejmoa1112843_f2.gif
Kaplan–Meier Curves for the Cumulative Probabilities of Death and of the Composite End Point at 6 Months, According to Treatment Group.

At 6 months, the rate of the composite of death from any cause, embolic events, recurrence of infective endocarditis, or repeat hospitalization due to the development of congestive heart failure was 3% in the early-surgery group, as compared with 28% in the conventional-treatment group (hazard ratio, 0.08; 95% CI, 0.01 to 0.65; P=0.02). The estimated actuarial rate of end points was significantly lower in the early-surgery group than in the conventional-treatment group (P=0.009 by the log-rank test) (Figure 2B).

Conclusion: Early surgery performed within 48 hours after diagnosis reduced the composite primary end point of death from any cause or embolic events by effectively reducing the risk of systemic embolism. Moreover, these improvements in clinical outcomes were achieved without an increase in operative mortality or recurrence of infective endocarditis.

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Early Surgery May Benefit Some With Heart Infection

Reporter: Aviva Lev-Ari, RN

 

Early Surgery May Benefit Some With Heart Infection, but doctors say findings only apply to a certain few

June 27, 2012 

By Denise Mann
HealthDay Reporter

http://health.usnews.com/health-news/news/articles/2012/06/27/early-surgery-may-benefit-some-with-heart-infection?page=2

WEDNESDAY, June 27 (HealthDay News) — People with an advanced form of a heart infection called endocarditis may do better if they undergo early surgery than if they are treated with antibiotics initially, a new study suggests.

Infective or bacterial endocarditis occurs when bacteria settles in the heart lining or heart valve. In advanced cases, the abnormal bacterial growth, often called vegetation, can be large enough to break off and travel elsewhere in the body, such as to the brain, where it may cause a stroke. Advanced infective endocarditis can also damage the heart valve.

People with existing heart disease or heart-valve problems are most likely to develop endocarditis.

In a new study published June 28 in the New England Journal of Medicine, researchers evaluated close to 80 people, average age 47, with advanced infective endocarditis.

Of these, 37 had early surgery within 48 hours of their diagnosis, and 39 received conventional therapy with antibiotics while they were monitored to see if the infection abated. Thirty people placed in the conventional treatment group eventually had surgery.

Early surgery reduced the risk of developing an embolism (or clot) and did not increase the risk of in-hospital death, the study showed.

After six months, the rate of adverse events, including death, repeat hospitalization for congestive heart failure or a recurrence of endocarditis, was 3 percent in the early-surgery group versus 28 percent in the conventionally treated patients.

“Early surgery can be the preferred option to further improve clinical outcomes of infective endocarditis, which is associated with considerable morbidity and mortality,” said study author Dr. Duk-Hyun Kang, a cardiologist at University of Ulsan College of Medicine in Seoul, South Korea.

“If a patient with infective endocarditis has large vegetations and severe valve disease, we would advise them to request early referral to medical centers with adequate experience and resources for early surgery,” Kang said.

Surgery for infective endocarditis aims to remove all infected tissue, repair the heart tissue and repair or replace the affected valve.

Others experts said only certain patients would warrant early surgery.

The new study “showed that patients with the combination of large vegetations and valve dysfunction, even if they are stable and not in heart failure, have a high risk of suffering serious embolic events or to progress to heart failure with need for emergency surgery and that early surgery prevented these complications,” said Dr. Gosta Pettersson, co-author of an accompanying journal editorial and vice chair of thoracic and cardiovascular surgery at the Cleveland Clinic in Ohio.

Surgery does have its share of risks, however. “Historically, surgery for infective endocarditis was high-risk surgery, and the risk of recurrent infection on the replacement valve was also high,” he said.

“Today, several publications have demonstrated that the added risk of operating on a patient with active infection has been more or less neutralized,” Pettersson added.

Surgeons have become adept at removing all infected tissue and foreign material and determining how best to reconstruct the heart, he explained. “Taking care of this patient is a team work with close collaboration between infectious disease specialists, cardiologists and cardiac surgeons,” he said. Importantly, he noted, “surgery is a complement to antibiotics not an alternative.”

Not everyone with infective endocarditis should have surgery, Pettersson said. For example, the stable patient with small vegetations, preserved valve function and growth of bacteria sensitive to antibiotics does not need surgery. Severely ill patients who are unlikely to survive an operation or those who have irreversible brain damage from embolism would not be surgical candidates either, he pointed out.

Dr. Stephen Green, chief of cardiology at North Shore University Hospital in Manhasset, N.Y., said that the new findings only apply to a select few. “Patients in the study had very large vegetation and severe valve pathology,” Green said. “These tend to be the worst of the worst.”

Most people with infective endocarditis are treated with antibiotics. “We reserve surgery for people whose infections don’t resolve, have fever or bacteria in the bloodstream or whose valves get destroyed,” Green noted.

“Many people with milder forms can be treated with antibiotics and monitored long term to see if they need surgery,” he added. This study suggests that “if you get a really bad clump of stuff on a valve, even if it’s antibiotic-sensitive, maybe we should go to surgery earlier.”

More information

Learn more about infective endocarditis at the American Heart Association.

Copyright © 2012 HealthDay. All rights reserved.

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Curator: Aviva Lev-Ari, PhD, RN

Edwards Lifesciences Corporation, Irvine, California delivers acute hemodynamic monitoring & heart valves. Their new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve diseases. Their embolectomy catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Edwards Lifesciences Reports Strong 2012 Fourth Quarter Results

February 5, 2013

IRVINE, CA, February 04, 2013 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended December 31, 2012, of $91.1 million, or $0.77 per diluted share, compared to net income of $63.1 million, or $0.53 per diluted share, for the same period in 2011.

During the quarter, the company recorded a global realignment pretax charge of $9.0 million, primarily related to severance costs. Additionally, in its non-GAAP results for the quarter, the company included an $8.4 million tax benefit, which represents the portion of the recently renewed Federal research and development (R&D) tax credit that is retroactive to the beginning of 2012. In the quarter ending March 31, 2013, the company will record the 2012 tax credit as required, but will exclude it from non-GAAP results. The impact of these special items was $0.13 per diluted share.

Adjusting for special items from both periods detailed in the reconciliation table below, fourth quarter diluted earnings per share were $0.90, compared to $0.62 in the prior year quarter, an increase of 45.2 percent.

Fourth quarter net sales increased 18.7 percent to $510.5 million compared to the same period last year. Sales growth excluding the impact of foreign exchange was 21.2 percent.

“Our fourth quarter capped a year of significant progress as we introduced our innovative SAPIEN technology to the U.S.,” said Michael A. Mussallem, chairman and CEO. “We are very proud that more than 5,000 patients in the U.S. have been treated with our transcatheter valves since launch, and we are aggressively investing to expand the availability of this important therapy. In spite of a difficult economic environment, underlying(1) sales were up 16 percent in 2012 driven by a strong finish in each of our product lines.”

Sales Results
For the fourth quarter, the company reported Surgical Heart Valve Therapy product group sales of $197.7 million, which included $29.1 million of cardiac surgery systems sales. Sales grew 3.8 percent over the fourth quarter last year, or 5.5 percent excluding the impact of foreign exchange. Growth outside the U.S. was 4.0 percent, or 7.2 percent excluding the impact of foreign exchange, while sales in the U.S. grew 3.5 percent.

Sales of transcatheter heart valves (THV) were $161.0 million for the quarter, a 72.8 percent growth over the fourth quarter last year, or 77.2 percent excluding the impact of foreign exchange. These results were driven by the ongoing U.S. launch of the SAPIEN valve, with total U.S. THV sales of $80.7 million. Outside the U.S., sales grew by 5.5 percent, or 10.0 percent excluding the impact of foreign exchange.

“We continue to expect underlying transcatheter heart valve sales to grow 30 to 45 percent in 2013. This would result in global sales of $710 million to $790 million, which includes $390 million to $440 million of sales in the U.S.,” Mussallem said.

Critical Care product group sales were $151.8 million for the quarter, including vascular sales of $13.8 million. Critical care sales were $138.0 million, representing growth of 3.5 percent, or 6.0 percent excluding the impact of foreign exchange. Growth was driven primarily by advanced monitoring products in Japan and the U.S.

Domestic and international sales for the fourth quarter were $224.9 million and $285.6 million, respectively.

Additional Operating Results
For the quarter, Edwards’ gross profit margin was 75.4 percent, compared to 72.2 percent in the same period last year. This improvement was driven primarily by a more profitable product mix and the impact from foreign exchange.

Selling, general and administrative expenses were $177.9 million for the quarter, or 34.8 percent of sales, compared to $163.4 million, or 38.0 percent of sales, in the same period last year. The increase in expenses was driven primarily by U.S. transcatheter launch-related investments.

Research and development for the quarter grew 23.4 percent to $74.9 million, or 14.7 percent of sales. This increase was the result of additional investments in clinical studies and new product development efforts in all of the company’s product lines.

Free cash flow for the quarter was $70.6 million, defined as cash flow from operating activities of $126.4 million, less capital spending of $55.8 million.

Cash and cash equivalents and short-term investments were $521.4 million at the end of the quarter. Total debt at December 31, 2012, was $189.3 million.

During the quarter, the company repurchased approximately 2.1 million shares of common stock for $186.9 million. At December 31, 2012, approximately $248 million was available for share repurchase under the company’s existing share repurchase authorization.

Twelve-Month Results
For the twelve months ended December 31, 2012, the company recorded net income of $293.2 million, or $2.48 per diluted share, compared to $236.7 million, or $1.98 per diluted share, for the same period in 2011. On a non-GAAP basis, earnings per diluted share were $2.69, compared to $2.02, a 33.2 percent increase.

Net sales for the twelve months of 2012 increased 13.2 percent to $1.90 billion. Underlying sales growth was 16.2 percent.

Domestic and international sales for the twelve months were $812.1million and $1,087.5 million, respectively.

Free cash flow for the year was $253.1 million, defined as cash flow from operating activities of $373.8 million, less capital spending of $120.7 million.

During 2012, the company repurchased approximately 4.0 million shares of common stock for $353.2 million.

Outlook
“We expect another exciting year for Edwards Lifesciences with continued strong sales growth, greater operating leverage, and progress on a number of important clinical milestones,” Mussallem said. “To strengthen our leadership position we plan to continue investing substantially in the development of transcatheter valves and other structural heart disease therapies, as well as in critical care technologies. We believe our focused innovation strategy, together with our global presence and strong financial footing, uniquely position us to drive strong, sustainable growth, while we help treat additional patients.

“We continue to expect full year sales of $2.1 billion to $2.2 billion and earnings per diluted share, excluding special items, of $3.21 to $3.31,” said Mussallem. “For the first quarter 2013, we project total sales of $505 million to $530 million and diluted earnings per share, excluding the $0.07 benefit from the 2012 R&D tax credit and any other special items, between $0.74 and $0.78.”

 

SOURCE:

http://www.fiercemedicaldevices.com/press-releases/edwards-lifesciences-reports-strong-fourth-quarter-results?utm_medium=nl&utm_source=internal

Read more: Edwards Lifesciences Reports Strong Fourth Quarter Results – FierceMedicalDevices http://www.fiercemedicaldevices.com/press-releases/edwards-lifesciences-reports-strong-fourth-quarter-results#ixzz2K3FNImH7

History of Edwards Lifesciences

 Edwards Lifesciences’ roots date to 1958, when Miles “Lowell” Edwards set out to build the first artificial heart.

Edwards was a 60-year-old, recently retired engineer holding 63 patents in an array of industries, with an entrepreneurial spirit and dreams of helping patients with heart disease.  His fascination with healing the heart was sparked in his teens, when he suffered through two bouts of rheumatic fever, which can scar heart valves and eventually cause the organ to fail.

With a background in hydraulics and fuel pump operations, Edwards believed the human heart could be mechanized.  However, when he presented the concept to Dr. Albert Starr, a young surgeon at the University of Oregon Medical School, the idea was met with hesitation.  Instead, Starr encouraged Edwards to focus first on developing an artificial heart valve, for which there was an immediate need.  

After only two years, the first Starr-Edwards mitral valve- which is not longer available for sale – was designed, developed, tested, and successfully placed in a patient.  Newspapers around the world reported on what they termed a “miraculous” heart surgery.  

This innovation spawned a company, Edwards Laboratories, which set up shop in Santa Ana, Calif. — not far from where Edwards Lifesciences’ global headquarters is located today.

Edwards Lifesciences’ heart valve expertise has led to the development of one of the most exciting opportunities in the cardiovascular field – transcatheter heart valve replacement.  The specially-designed valve and delivery system*  is being evaluated in clinical studies in which high-risk patients receive a valve replacement without traditional open-heart surgery and while their heart continues to beat.  Clinicians replace a patient’s aortic valve via a catheter inserted into a small incision in either the leg or between the ribs.  Edwards Lifesciences’ leadership in transcatheter heart valve replacement includes a commitment to rigorous scientific study of the procedure and to extensive clinician training and education.

Consistent with this effort to explore less invasive surgery, the company is committed to providing tools for minimally invasive cardiac surgery that allow cardiac surgeons to perform heart valve operations through small openings, or “ports,” in the spaces between the ribs.

http://cardiovascular.eng.uci.edu/edwardslifesciences/history

In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

This study is currently recruiting participants.

Verified May 2012 by Edwards Lifesciences

 First Received on March 7, 2011.   Last Updated on May 23, 2012   History of Changes

Sponsor:

Edwards Lifesciences

Information provided by (Responsible Party):

Edwards Lifesciences

ClinicalTrials.gov Identifier:

NCT01314313

  Purpose

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems: NovaFlex (transfemoral access) and Ascendra2 (transapical access) in patients with symptomatic, calcific, severe aortic stenosis.

Condition Intervention Phase
Symptomatic Severe Aortic Stenosis Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: AVR with a surgical heart valveDevice: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis Phase 3
Study Type: Interventional
Study Design: Allocation: RandomizedEndpoint Classification: Safety/Efficacy StudyIntervention Model: Parallel AssignmentMasking: Open LabelPrimary Purpose: Treatment
Official Title: The PARTNER II Trial “Placement of AoRTic TraNscathetER” Valves Trial” (US) [Edwards Study 2010-12]

http://www.clinicaltrials.gov/ct/show/NCT01314313?order=4

Unparalleled Commitment to Research

The research vision for The Edwards Lifesciences Center for Advanced Cardiovascular Technology is a dynamic process and will be developed and implemented by the Center and faculty.

The broad vision will encompass basic research and development of new technologies focused on the treatment of cardiovascular disease. 

The breadth of this vision will allow the flexibility to recruit the most outstanding faculty in the cardiovascular field, as well as allow the Center’s research activity to move quickly into new areas while remaining focused in the cardiovascular system.  Potential areas of expertise and focus will include, but are not limited to:

  •       Valve replacement technology
  •       Regenerative and degenerative cardiovascular medicine (including tissue engineering and stem cell biology)
  •       Non-invasive (wireless) cardiovascular monitoring, intervention, and imaging
  •       Novel stent or catheter-based therapies including new biological coatings

The engineering expertise that will be applied to these areas include Micro-Electro-Mechanical Systems (MEMS), nanotechnology, biophotonics, biomaterials, systems biology, and computation/modeling.

Core Facilities

The Center has three fully functional core research facilities, and a fourth facility in the final planning stages.  The facilities will provide unique and/or synergistic instrumentation and expertise for the campus and community.  Access to the core facilities is limited to faculty members who are members of the Center and their trainees. The core facilities are briefly described below, and more information about the instrumentation, access, training, and reservations can be found on each facility’s page:

1.    Surgical and Imaging Facility (SIF).  The SIF is currently in a planning stage.  This facility could potentially provide a major resource to the campus, not only for cardiovascular research, but other organ systems that need small and large animal models, as well as training opportunities for UC Irvine and community-based cardiologists, scientists, or sales representatives from local companies.  The planned facility will include the following functionalities:

Complete catheterization including hemodynamic monitoring with bi-plane fluoroscopic imaging

Ultrasound

MicroCT

MicroPET (positron emission tomography)

MicroSPECT (single positron emission computed tomography)

OCT (optical computed tomography)

In addition to the catheterization lab, a fully functional operating room for both acute and chronic procedures are planned.

2.    Cell and Tissue Facility (CTF) The Cell and Tissue Facility, located in  Engineering Hall rooms 2110 and 2128, is a complete cell-culturing facility.  The center offers six biosafety cabinets, two water baths, six CO2 incubators – including one for oxygen tension control – two benchtop incubators – including one for oxygen tension control – centrifuges with refrigeration capabilities, three cell culture microscopes, refrigeration, -80C and -20C freezers, liquid nitrogen storage, and a purified water source.

3.    Mechanical Testing Facility (MTF).  This core facility provides two basic instruments for investigating mechanical properties.  The Synergie 100 system performs tension or compression testing, while the rheometer provides the capability to study dynamic and shear properties. The instruments are housed in Engineering Hall room 2115.

4.    Microscopy Core Facility (MCF).  Microscopy Core Facility has multiple imaging capabilities, including confocal, fluorescence, differential interference contrast, phase contrast, darkfield, and brightfield microscopy. This core facility is equipped with a Nikon Eclipse TE300 Inverted Scope with Nikon PCM2000 Confocal Attachment, an Inverted Eclipse TE300, and an Upright Eclipse E800 w/ VFM epi-fluorescence attachment.  Each microscopy is equipped with a 12-bit CCD camera; specifications can be found on the facility’s website.

http://cardiovascular.eng.uci.edu/book/export/html/12

Executive Compensation in the Cardiology and Cardiac Surgery Medical Devices Market: Comparison of Edwards Lifesciences Corporation with other Suppliers – Analysis of the SAPIEN Contribution

Edwards Lifesciences Corporation

NOTICE OF 2012 ANNUAL MEETING OF STOCKHOLDERS

To be held on Thursday, May 10, 2012

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

Definition of a Comparator Group for Determination of Executive Compensation. Edwards Lifesciences 2011 Comparator Group include:

Allergan, Inc.

Masimo Corp.

Becton Dickinson & Co.

Medtronic, Inc.

Boston Scientific Corp.

PerkinElmer, Inc.

C. R. Bard, Inc.

ResMed, Inc.

CareFusion, Inc.

St. Jude Medical, Inc.

Covidien plc

Stryker Corp.

Gen-Probe, Inc.

Thoratec Corp.

Hospira, Inc.

Varian Medical Systems, Inc.

Illumina, Inc.

Zimmer Holdings, Inc.

Integra Lifesciences Holding Corp.

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

p.28

In the Chairman of the board address:  2011 Performance was Strong. The year 2011 was one of significant investment and major milestones. Successful PARTNER trial results culminated in U.S. regulatory approval to begin commercially offering the SAPIEN transcatheter heart valve to many inoperable patients. We developed a rigorous training program to promote the teamwork of cardiac surgeons and interventional cardiologists, and to emphasize excellent clinicalresults. To support expected growth, we expanded our heart valve manufacturing capacity, and made additional enhancements to our infrastructure, including our information and quality systems.As a result of the combined efforts of our management team and their employees, in 2011, theCompany delivered another year of strong financial performance. The company-wide financial measures usedto determine 2011 incentive compensation consisted of goals for revenue growth, net income, and free cashflow.

The following table shows the 2011 results for these three metrics compared against the 2011 targets and the comparable performance measures for 2010 and 2009:

                                                                        2011     2011     2010    2009

                                                                        Actual Target Actual Actual

Revenue Growth* . . . . . . . . . . . . . . . . . . . . . 11.0%** 11.4%** 12.7% 11.4%

Net Income* . . . . . . . . . . . . . . . . . . . . . . . . $259.6** $244.0** $218.9 $181.5

Free Cash Flow* . . . . . . . . . . . . . . . . . . . . . $215.0** $215.0** $196.2 $178.1

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

p.25

Comparison of Cumulative Five Year Total Stock Return

2007

2008

2009

2010

2011

Edwards Life Sciences

98

117

185

344

301

S&P

104

64

79

89

89

Morgan Stanley  Health Care Products

103

82

102

109

115

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.26

Pay for Performance Philosophy.The Compensation Committee strongly believes that executive compensation should be tied to performance and strives to create a pay for performance culture. Our compensation objectives are to offer programs that emphasize performance-based compensation and align the financial interests of our executives with those of the Company’s stockholders. Accordingly, approximately 80% of the total direct compensation of our Chairman of the Board and Chief Executive Officer (the ‘‘Chairman and CEO’’) and our Named Executive Officers is at risk based upon the performance of the Company. p.26

Company

CEO TDC (Average) (in thousands)

Most Recent FY

Last 3 FYs

Last 5 FYs

2011 Comparatoe Group

90th Percentile

$10,627

$11,110

$10,398

75th Percentile

$9,590

$10,012

$9,143

Median

$7,839

$7,748

$7,836

25th Percentile

$5,011

$5,008

$5,228

Edwadrs Lifesciences

$5,829

$5,789

$5,567

Percentile

36.60%

33.90%

26.60%

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.29

When compared to the competitive data based on the 2011 Comparator Group, the average base salary compensation paid to the Named Executive Officers for the 2011 fiscal year was approximately 2.5% below the median, the total cash compensation was at the median, and total direct compensation was approximately at the median. The following chart illustrates the total direct compensation of our Chairman and CEO.

The total stockholder return (TSR) for the Company’s common stock for the previous one, three, and five years, compared to the data of our 2011 Comparator Group:

2011 Edwards Most Recent Return: -11.8%, 42 percentile

Last 3 FYs 55.6%, maximum percentile

Last 5 FYs 37.3%, maximum percentile

2011 Comparator Group: 90th percentile subgroup, Most Recent TSR 7.6%

Last 3 FYs 18.9%

Last 5 FYs 8.5%

Executive compensation at Edwards in 2012 will increase significantly as a direct results from the Edwards’ stock soars after FDA panel nod on expanded Sapien valve use

On June 14, 2012:

Stock Price and Trading Volume 7/2011 to 6/14/2012

http://www.dailyfinance.com/quote/nyse/edwards-lifesciences-corp/ew/charts

Stock Price and Trading Volume 5/21/2012 to 6/14/2012

http://www.dailyfinance.com/quote/nyse/edwards-lifesciences-corp/ew/charts

Edwards Lifesciences Corp. (EW) won the backing of U.S. advisers for an expanded use of the company’s Sapien heart valve as an alternative to open-heart surgery. Edwards’ transcatheter aortic heart valve may soon have two indications: for aortic stenosis patients who are both inoperable and at high risk for surgery.

Smith, PARTNER trial’s principal investigator of Cohort A during the sponsor presentation, urged that the higher frequency of neurological events that occurred within the TAVR group should not be “trivialized” in either treatment group. Smith called aortic stenosis “one of the conditions we understand best in cardiovascular disease.” He called transcatheter aortic valve replacement (TAVR) a “miracle therapy,” and said that outcomes for the procedure will only continue to improve. And while most of the day’s conversation gave kudos to the PARTNER trial and its findings, concerns did focus on gender differences and neurological events.

Mark Hollmer explains that Edwards Lifesciences ($EW) scored a major win on Wednesday, successfully making its case before an FDA panel of experts that its Sapien transcatheter heart valve should be used in a broader class of patients. The agency’s Circulatory Systems Advisory Committee voted 11-0 (one panelist abstained) that the benefits outweighed any risks in using the valve for patients with severe aortic stenosis who are high-risk but could otherwise undergo surgery.

Investors reacted favorably, driving Edwards’ stock up more than 8% to $98.55 by midday on June 14. Bloomberg, MedPage Today, The Associated Press, CardiovascularBusiness and many others covered the day-long panel meeting and final vote. While the FDA doesn’t have to follow the panel’s recommendation, it usually does. Panel members also voted 12-0 that Sapien is effective and 10-2 that the valve is safe.

When the FDA comes out with its final decision is anyone’s guess, but Bloomberg predicts final action could come in October, based on the timeline for Sapien’s initial approval in 2011 (panel meeting in July; regulatory approval in November). Sapien initially gained FDA approval for patients with limited classes of stenosis who can’t have surgery.

To make its case during the 8-hour-plus hearing, Edwards Life Sciences relied on the “Cohort B” part of its pivotal PARTNER trial, which compared transcatheter aortic valve implantation (TAVI) with surgery. (“Cohort A” was used for the initial approval in November.) PARTNER recruited 699 high-risk older patients with severe aortic stenosis and randomly assigned them to TAVI (n=348) or surgery. About two-thirds of the TAVI patients underwent transfemoral procedures, where the device was threaded through the femoral artery, while 103 had transapical access procedures, where the device was inserted directly into the tip of the left ventricle of the heart.

Death rates were essentially the same at 1 year for the Sapien group and the control group. When divided up by type of valve implantation compared with matched surgery controls, the death rate for Sapien implanted via a transfemoral approach was 24.2% versus 26.8% for surgery; and for the transapical approach the 1-year mortality rate was 22.2% for the Sapien group and 26.4% for the open-heart surgery group. Although the death rate was very similar, TAVI patients had double the rate of stoke during the 30-day period following the procedure. With the transapical approach, there appeared to be an even greater increased risk for early stroke, which the panel chalked up to the fact that patients who received TAVI via transapical approach were sicker patients, so their outcomes were poorer than those who were implanted via a transfemoral approach.

The trial involved 699 older patients of high risk with severe aortic stenosis who were randomly assigned to the TAVI procedure or surgery. Among the findings: the death rate was similar for both, but patients who had transcatheter aortic valve implantation faced double the rate of stroke over the initial 30-day period after the surgery. That finding concerned both FDA scientists and panel members, though Edwards countered that stroke rates evened out after another year, Bloomberg notes. Regulators in advance of the hearing were also bothered by how the company chose patients and categorized them for the trial, arguing that it constituted bias to some degree, and potentially skewed the results.

Edwards wants to do a post-approval study to follow patients from the trial and also create a registry to enroll new patients. FDA staff members agree, and urged at least 5 years of follow-up for subjects from the trial.

http://www.fiercemedicaldevices.com/story/edwards-lifesciences-argue-expanded-sapien-valve-use/2012-06-12?utm_medium=nl&utm_source=internal

 http://www.medpagetoday.com/Cardiology/PCI/33263

Transcatheter Heart Valve Replacement Market: A Market of $2.5 Billion in the US

The market for transcatheter valves may total $2.5 billion in the U.S., said Jason Mills, a San Francisco-based analyst with Canaccord Adams Inc. The initial FDA approval of Sapien in November boosted Edwards’s sales 67 percent in the first quarter to $122 million, Michael Mussallem, the company’s chairman and chief executive officer, said in an April 24 earnings call.

The device is meant to treat aortic stenosis. The debilitating condition is caused by a narrowing valve that restricts the ability of blood to enter the aorta, the main artery that carries blood from the heart, according to the National Institutes of Health.

“A broader indication for high-risk patients would enable multidisciplinary heart teams to choose the approach best suited to their patients’ needs,” Mussallem said in a statement after the panel’s vote. “We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis.”

The FDA may decide on approval in October if reviewers follow the same timeline they did when they cleared the valve for inoperable patients. Advisers met in July to consider the device for inoperable patients and approved it in November.

http://www.cardiovascularbusiness.com/index.php?option=com_articles&view=article&id=34321:sapien-makes-more-headway-in-aortic-stenosis-world

Another point of concern, as Bloomberg points out: FDA staff noted that patients treated with Sapien faced twice the stroke risk in the initial month after the implant procedure, compared to patients who had open-heart surgery instead.

The FDA wants the company to commit to a long-term follow up, post-approval study that tracks patients for at least 5 years to address its concerns. Edwards appears to be on the same page, having proposed a post-approval study that would follow patients from its pivotal trial, as well as a new patient registry, according to the story.

http://www.fiercemedicaldevices.com/story/edwards-lifesciences-argue-expanded-sapien-valve-use/2012-06-12?utm_medium=nl&utm_source=internal

Edwards won a PMA for the Sapien device for inoperable patients with aortic stenosis, a hardening and narrowing of the aortic valve, in November 2011.* FDA reviewers said the arm of the study covering the high-risk patients may have been flawed by the inconsistencies.

“FDA notes that screening and subsequent enrollment practices were not homogenous. The large variation between the ratios of those screened to those enrolled may represent different selection criteria among sites,” according to documents released ahead of the meeting scheduled for Wednesday. “Enrollment practices related to identification of ‘inoperable’ and ‘high risk’ patients were not homogenous across sites.”

https://www.massdevice.com/news/fda-possible-selection-bias-issues-confound-edwards-sapien-study

FDA Panel

There was “no significant difference” in mortality between patients treated with surgery vs. treatment with the Sapien valve, according to the documents. But some patients who were slated for traditional open heart surgery were treated with the TAVI device, and vice-versa, making it difficult to evaluate the study’s endpoints.

“[T]he issue of [surgery] patients not receiving [surgery], [Sapien] patients receiving [surgery], and [surgery] patients undergoing concomitant operations makes evaluation of these endpoint results difficult,” according to the FDA reviewers. “Although the primary endpoint was met, issues related to potential selection bias confound the interpretation of these results.”

“We believe the Partner trial was well-designed and executed. We are proud of the efforts of the leading heart teams that supported this ground-breaking trial and what it means for patients,” an Edwards spokeswoman told MassDevice.com via email. “We are reserving further comment on this or related matters until the Advisory Committee scheduled for June 13.”

The FDA also wants the circulatory devices panel to consider better ways to construct future trials of similar devices and to come up with appropriate endpoints for a post-market surveillance study. The panel is scheduled to vote on whether the device is as safe and effective as surgery and whether its benefits outweigh its risks for the high-risk cohort.

https://www.massdevice.com/news/fda-possible-selection-bias-issues-confound-edwards-sapien-study?page=2

Medicare to Cover Edwards’ Sapien Heart Valve

On May 2, 2012 Mark Hollmer reported that for medical device companies, gaining Medicare reimbursement for surgical procedures involving their implants can be a sort of financial holy grail. After all, an implant won’t be used much if the cost can’t be covered. Edwards Lifesciences ($EW) has reached that point now that the Centers for Medicare & Medicaid Services has agreed to pay for surgery involving its Sapien transcatheter heart valve. Ssince Sapien’s U.S. debut in November. As a result, sales should get a boost, Wells Fargo analyst Larry Biegelsen said, as quoted by Bloomberg in its coverage of the news.

Specifically, CMS approved reimbursement of transcatheter aortic valve replacement therapy when the device is used to treat symptomatic aortic valve stenosis. The coverage determination is flexible and authorizes current and future FDA approved indications, the company notes, as well as coverage for clinical studies.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA. Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Sapien valve is usually threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. An alternate procedure inserts the valve through a small incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve. In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

http://www.mercurynews.com/business/ci_20850361/fda-panel-backs-broader-use-edwards-heart-valve

Two cardiac surgeons must independently evaluate the patient first, and hospitals offering the procedure must have an on-site heart valve surgery program, plus a cardiac catheterization lab or a lab/operating room hybrid with appropriate imaging systems. And as Bloomberg points out, the guidelines limit who can conduct the procedure to a multidisciplinary team of doctors that must include at least one heart surgeon and interventional cardiologist. And those experts must perform the surgery at least 20 times annually to remain certified.

CMS also requires the heart team and hospital to take part in a post-surgery clinical trial, a national registry that follows patients who have the procedure for at least one year. This study will look at variables including strokes, death, heart attacks, kidney injuries, any repeat procedures and overall quality of life.

Sapien, generated $41 million in sales during the first quarter, the first full quarter the device has been on the market.

http://www.fiercemedicaldevices.com/story/medicare-cover-edwards-sapien-heart-valve/2012-05-02?utm_medium=nl&utm_source=internal

June 13, 2012 – FDA panel votes in favor of Sapien valve.  The FDA’s Circulatory System Devices Committee gave Edwards Lifesciences ($EW) a win Wednesday with a vote recommending the devicemaker’s Sapien transcatheter heart valve after an epic session. The panel voted 9-0–with one member abstaining–that the device’s benefits outweighed its risks, 7-3 in favor of its safety, and 9-1 for its effectiveness. The FDA will make a decision on the valve at a later date.

Earlier in the week, the FDA released a report showing the valve, which can be implanted without major surgery, significantly reduced death rates versus standard therapy in people with severe aortic stenosis. However, there was a higher incidence of major strokes and major vascular events seen in the group receiving the Sapien valve in a study.

Indeed, neurological events represented a major issue in the meeting, as heartwire notes, with several panel members pointing out that older, frail patients are far more concerned about strokes than death. Furthermore, mortality reduction with TAVI is, as the FDA terms it, impressive, but most treated patients die within two years. That said, panel members concluded that the benefits of transcatheter valve replacement in these frail patients offset the stroke risk.

“We are pleased with the panel’s strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from The PARTNER Trial. This represents another important step on the path to what we hope will lead to FDA approval of SAPIEN,” Michael Mussallem, Edwards’ chairman and CEO, says in a statement. “We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy.”

Edwards has marketed Sapien in Europe since 2007 and could start selling it in the U.S. in Q4, 2012. Analysts note the worldwide market for heart valves could ultimately grow to $2 billion in annual sales, as the Orange County Business Journal reports.

http://www.fiercemedicaldevices.com/story/fda-panel-votes-favor-sapien-valve/2011-07-20

The valve SAPIEN is currently approved for patients who aren’t healthy enough to undergo the more invasive open-heart surgery, which has been used to replace the aortic valve for decades. On June 13, 2012 – the implant is approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.

Irvine, Calif.-based Edwards plans to conduct two follow-up studies to evaluate long-term safety as well as differences in gender outcomes per FDA panel on June 13, 2012.

Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions described in

https://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

CONCLUSIONS

 The Pay for Performance Philosophy at Edwards Lifesciences will support a substantial reward for the Chairman and CEO in 2012. His $5.8 Million in total compensation in 2011, occurred for a average of Five Year Total Stockholders Return of 301% while at the same time S&P delivered an anemic Five Year Total Stock Return of 89% per 2011 Edwards Most Recent Return: -11.8%, 42 percentile as reported in 2011 Edwards Annual Report. With the potential of EW symbol exceeding $100 per share in the second half of 2012, CEOs total compensation may move Edwards from the 36 percentile to the median in the Comparator Group selected for determination of Executive compensation at Edwards. . In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

FDA’s broadening definition of patients eligible for TAVR to include other patients than the ones with aortic stenosis that can’t undergo open heart surgery, will have an immediate effect on the total cost that these procedures will bear by having the procedure been covered by Medicare and Medicaid. An increase in the Healthcare cost and its National burden is expected. Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve.

The Procedure will have a major improvement in the quality of life of patients undergoing TAVR with a favorable impact on their longevity.

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Reporter: Aviva Lev-Ari, PhD, RN
The Edwards SAPIEN transcatheter heart valve is an investigational device which is placed either through a transfemoral (RetroFlex 3 Transfemoral Delivery System) or transapical (Ascendra Transapical Delivery System) approach. The Edwards SAPIEN valve is being evaluated in the treatment of patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-heart valve replacement surgery.

Cohort A of the PARTNER (Placement of AoRTic traNscatheterER valves) Trial is designed for patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-chest valve replacement due to the risk surgery might pose to them. These patients may be eligible to participate in a new, investigational transcatheter valve replacement procedure that is performed without

 http://www.edwards.com/products/investigationaldevices/Pages/SapienTHV.aspx

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Reporter: Aviva Lev-Ari, PhD, RN
The Edwards SAPIEN transcatheter heart valve is an investigational device which is placed either through a transfemoral (RetroFlex 3 Transfemoral Delivery System) or transapical (Ascendra Transapical Delivery System) approach. The Edwards SAPIEN valve is being evaluated in the treatment of patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-heart valve replacement surgery.Cohort A of the PARTNER (Placement of AoRTic traNscatheterER valves) Trial is designed for patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-chest valve replacement due to the risk surgery might pose to them. These patients may be eligible to participate in a new, investigational transcatheter valve replacement procedure that is performed without

Read Full Post »