Great Reward Must Come With Great Risk? Sunshine Heart May Be An Exception

Sunshine Heart (SSH) announced a public offering of 3.8M shares at $10.5/share last week. SSH now has about $54.4 million cash after the offering. Given its current cash burn rate at $4.2M per quarter, the company is funded well into late 2016. Currently the intuitional ownership is about 44.2%. After the offering, the institutional ownership could be well above 60%.

The multi-billion market potential of C-pulse has been elaborated upon several times by different SeekingAlpha authors. You may think that such huge potential reward in Sunshine Heart must come with great risk as well. It appears so on surface. Up to today all we have are the data from 20-patient feasibility study. The study is not a randomized trial and has no control arm. How could we, as skeptical biotech investors that have seen so many failures in bio-land, have much faith in the future success of this device? In this article, I will try to make a comprehensive analysis of the clinical risks of C-pulse and you may be surprised that the clinical risks may not be as high as you originally thought.

Efficacy

Although it's a small 20-patient trial, there is little doubt about the efficacy:

Among the responders, 4 Class III improved to Class I, 7 Class III to Class II, and 1 Class IV to Class II;3 inteterminate patients are those non-complaint with device use < 80%;0% re-hospitalization rate within first 30 days, 5% at 6 months, and 15% at 12 months. The increase of hospitalization rate was actually due to patient non-compliance;MLWHF (quality of life score): 100% responder rate at 12 months;6-minute hall walk: 83% responder rate at 12 months;Two super responders permanently weaned from C-pulse;Two additional super responders have been identified for weaning.

Among the above evidences, 4 super responders out of 20 patients are the definitive signal of efficacy. These patients improved so much that they became asymptomatic and returned to all their normal activities in their daily livings. "Patients with chronic heart failure that is severe in nature after many years of development just don't suddenly get well on their own", said Dr. William Abraham, the PI of the feasibility trial and the U.S. pivotal trial, "such dramatic improvement can't be attributable to placebo effects or spontaneous recovery." As the matter of fact, the C-Pulse design is based on proven balloon counter-pulsation technology that has been used in 1960's. The mechanism is well studied and understood. Efficacy is the least thing I worry about among all the clinical risks.

Safety

Now let's turn to safety. C-pulse is not a drug, but a mechanical device. This would make safety analysis a bit easier, as we all know simple physical process usually is more predictable and transparent than chemical reaction. I will try to make a comprehensive list of potential sources of risks and analyze each of them one by one.

1) Risks of implantation operation.

During the feasibility trial, Sunshine Heart improved the implantation procedure by moving from open chest operation, or full sternotomy, to minimally invasive procedure. This minimally invasive procedure only takes 2-3 inches of incision among the ribs and doctors can implant the cuff through the incision. This new procedure shortened the hospital stay and reduced the infection risks. I see little risk involved in the implantation operation. According to Dr. Thoralf Sundt in Mayo Clinic, with today's technology, even the sternotomy incision is generally well tolerated, and patients are surprised a day or two after surgery that they really are not having much discomfort at all from it.

2) Risks of device failure/loss of power.

Although C-pulse is a new device, each of its component has been around for many years. The inflation/deflation is synchronized to the patients ECG, just like a pacemaker. The balloon counter-pulsation technique has been used in intra-aorta way for many decades. These are all mature technologies. Even if C-pulse stop working for some reason, it does not pose any immediate threats to patients, as the device does not replace the heart functions like LVAD device. The device can be turned on/off at will. In my view, C-pulse has a much larger margin for error/failure than LVADs.

3). Risks of infections at exit site.

This risk is real and very common for devices with exit through the skin. 8 patients had infections in the feasibility trial. The company gave very close attention to this issue. After the feasibility trial, they re-designed the device by adding a so-called "C-Patch" that mobilize the tube to reduce or minimize the gap between the tube and the skin when patients pull the tube. They even formed a special committee to oversee this issue. They asked patients to take pictures of the exit site once in a while and send them back to doctors to preempt the potential infections. I believe with such aggressive infection management strategies, this risk can be minimized.

4). Risks of Neurological events

This is actually the strength of C-Pulse. So far there has been zero neurological events recorded that is related to the device. C-Pulse is non-blood contacting and no need for blood thinning medication. All these reduced the risk infection and potentially stroke risk.

5). Risks of aorta damage/disruption

Based on recent interview with the company's CEO, two physicians that took tissue samples from patients right underneath the balloon and the samples 1cm to the right and 1cm to the left. They compare the tissues and found there were no differences. The earliest patients in the feasibility trial have been using the device safely for over 2-3 years. It appears that at least in short term, the cuff and balloon show no sign of damage to the wall of aorta. There has been no long term study of the effect on the aorta. Honestly, the long term aorta safety issue is the only issue I am not highly confident about. But we need to put this issue in the perspective. In the long run, we are all dead. The 5-year mortality rate for Class III/IV heart failure patients is over 50%. These late stage patients are usually very old already. For them, "long term" may be as long as you think. If C-pulse can give them over 5 years' high quality of life with improved heart function, I would say it is well worth the potential "long term" aorta risk.

6) Risks of other unidentified risks?

Maybe. Any MAJOR unidentified risks? I don't think so. Again, this is a mechanical device that just has so many touch points to patients body. It's not like a drug with unknown mechanism of actions.

To summarize, Sunshine Heart offers the best risk/reward ratio that I have not seen in biotech companies for many years. It's critical for investors to understand the clinical risks involved in the device, particularly as we are entering the phase that we will frequently get updates on European Option HF trial from Sunshine Heart. On Oct 28, the company will present initial EU clinical data at TCT conference in San Francisco. Even though this clinical update will probably only cover 4-5 patients, it's still a highly significant catalyst. According to 2nd quarter earning call, Germany reimbursement decision only requires clinical data from 5 patients. If the data are good, the company will very likely get favorable reimbursement decision in Feb 2014. That would mark the official start of the commercialization of C-pulse in Europe.

Caution: Please do your own research before any buy or sell decisions. Use of information and research in the article above is at your own risk. It's always risky to invest in development stage micro-cap biotech companies. SSH is a highly illiquid public company. The share price could be very volatile. Please check the full list of risk factors in the company's annual report.

Disclosure: I am long SSH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Sunshine Heart Stock Offering: Why Now?

After all, the company is presently quite well funded and the share price has risen considerably on the back of recent announcements.

There are a number of key announcements expected through 1st quarter 2014. These announcements could quite easily be catalysts for significant increases in the share price as each announcement is made. Holding off on a stock offering could avoid unnecessary dilution.

Some possible reasons for a stock offering now:

I would be confident that SSH Management will have very sound reasons for the timing of this stock offering.

The reasons will be strategic, rather than a need for cash right now. They might include:

Positioning to adopt a more aggressive approach to developing the market for C-Pulse;Providing a means for institutional investors to get on board;Taking money because it is presently on offer and available; andPreserving control and independence into the future.

I will address each of the above in more detail below, explaining why they are important considerations.

But first some background information on Sunshine Heart for those readers not familiar with this company.

Sunshine Heart's C-Pulse system:

The Sunshine Heart C-Pulse system is a medical device to treat congestive heart failure by assisting the natural heart's pumping function. To further explain:

The C-Pulse system is not blood-contacting and does not take over from the heart. It employs proven counter-pulsation technology, to reduce the workload of the heart, and to create additional blood flow to the heart muscle. This provides ongoing permanent support and allows a tired heart muscle some opportunity to rest and recover, in a measurable way (NYHA Heart Failure class improvement). For further information see here and here.

Some results from the C-Pulse 20-person feasibility study (Data sources: Prospectus filed with SEC August 10, 2012 and Sunshine Heart Corporate Presentation October 2012):

NYHA Heart Failure Class improvement - 12 patients (60%) at 6 months. (Subsequent to completion of the feasibility study 2 patients became asymptomatic and were weaned off the device and another 2 are being considered for weaning);Re-hospitalizations at 6 months 5% (compares to recent trial published control group re-hospitalization rate of over 40% with similar patient population at 6 months);Medication Reduction: Diuretics -discontinued, reduced or unchanged for all patients; Inotropes - 4/4 patents successfully weaned (within 48 hours).

Following on the successful completion of the feasibility trial, the FDA has approved a 388-patient pivotal trial with targeted marketing approval in early 2017. The C-Pulse already has CE Mark approval for commercial sale in the EU.

Sunshine Heart's financial metrics compared to Heartware:

In considering reasons for the current stock offering, it is useful to draw some comparisons with Heartware (HTWR). Heartware also operates in the heart assist device space and has been very successful in raising large amounts of capital while minimizing dilution.

Sunshine Heart, in pursuing its objectives, had accumulated losses through end of 2012 of ~$79M. Additional losses of ~$9M were incurred in the six months through 30 June 2013. Cash balance at end of June 2013 was $21.5M. Issued shares increased by ~33% to 12.4M in the six months ended 30 June 2013. Market cap at 13 September 2013 was $137M.

Below are comparative figures for Heartware, whose product is the MVAD, a Left Ventricular Device (LVAD), which addresses the late stage NYHA Class IV CHF market.

Heartware, in pursuing its objectives, had accumulated losses through end of 2012 of ~$270M. Additional losses of ~$26M were incurred in the six months through 30 June 2013. Cash balance at end of June 2013 was $190M. Issued shares increased by ~12.4% to 16.4M in the six months ended 30 June 2013. Market cap at 13 September 2013 was $1.278bn.

Sunshine Heart's target market is over 15 times HTWR's target market. Both have CE Mark for their devices, allowing commercial sales in the EU and other countries accepting the CE Mark. Both have ongoing trials targeting Destination Therapy (DT) approval for their devices in the USA by early 2017. HTWR does have Bridge To Transplant (BTT) approval in the US, but revenue from these sales is insufficient to date to offset the huge and ongoing R&D and trial costs it is incurring.

More comprehensive detail on reasons for a Sunshine Heart stock offering:

1. Positioning to adopt a more aggressive approach to developing the market for C-Pulse:

In 2014, Sunshine Heart will be in a very similar position to Heartware in 2009.

In 2009 Heartware commenced commercial sales in Europe and was heavily involved in its clinical trial for Bridge To Transplant approval in the USA.

Table 1 below shows just how cash hungry Heartware has been in developing its markets, conducting clinical trials, and researching and developing next generation LVADs to compete with Thoratec (THOR).

To date, Sunshine Heart has adopted a conservative approach. But this stock offering could be a sign it is about to aggressively launch its development of the EU market, where it has approval for commercial sales, and perhaps accelerate its enrollments in its US Pivotal trial.

Sunshine Heart should be able to do this with a far lesser level of expenditure than Heartware because it does not have the R&D costs of HTWR and THOR in developing entirely new and different next generation devices (devices that require new trials with risk of failure).

But Sunshine Heart will need to increase expenditures well above past levels to aggressively promote in the EU market and to accelerate its US trial.

Table 1 - Heartware - Loss From Operations 2009 to 2012 and 1st Half 2013

2. Providing a means for institutional investors to get on board:

The importance of this cannot be overstated.

Once institutions are on board, the company has a group of shareholders with a commitment and the means to fund the company to its end objectives.

This can be seen with Heartware when it recently had no difficulty at all in raising in excess of $200M with minimal dilution.

In my recent article, "HeartWare Might Have Missed The Boat: A Hedging Strategy," I described how shareholders in Heartware might hedge their positions in the mechanical heart assist device space by also acquiring some shares in Sunshine Heart.

I described the difficulty for institutional shareholders in carrying out such a hedging strategy as follows:

There are 147 institutional shareholders in HeartWare holding 98.33% of the issued shares.

Only 10 of these institutions already have shares in Sunshine Heart. The value of their combined holdings in Sunshine Heart is roughly 5% of the value of their combined HeartWare and Sunshine Heart shareholdings. So they already have a hedge in place.

The remainder of the institutions would have to acquire between 2.6M and 10.4M shares in Sunshine Heart to implement the above strategy.

So for the majority of these institutions, who are not quick enough to buy on market, the only way to achieve this hedging strategy might be to participate in a capital raising for Sunshine Heart.

If enabling more institutional shareholders to get on board was the sole reason for the current stock offering, it would be a very good reason by itself.

3. Taking money because it is presently on offer and available:

It is a truism in the capital markets that when you need money, no one wants to give it to you. But there will be no shortage of offers of money when you do not need it.

Dave Rosa, CEO of Sunshine Heart, referred to this counter intuitive situation in a recent interview organized by PropThink.

It is, of course, not only a matter of not needing the money, but also being perceived as not needing the money.

4. Preserving control and independence into the future -

In the PropThink interview referred to above, Dave Rosa discussed the desirability or otherwise of sourcing funding through a partnership.

He said, in part:

My own personal philosophy is you control your own fate.

While partnership arrangements are apparently available, the stock offering is obviously the preferred option going forward. It will certainly keep things simpler if there is an acceptable buyout offer in the future.

Other considerations:

If the stock offering takes away any investor concerns of SSH running out of cash, that is likely to have a positive effect on the share price.

Additional shares on issue plus a higher share price might lift SSH's market cap from micro cap to small cap level. That in itself could in turn be a further positive for the share price.

Caution: As always, please do your own research before any buy or sell decisions. Use of information and research in the article above is at your own risk.

Investing in micro cap companies is not suitable for all investors and can be risky. It's important that investors thoroughly perform their own due diligence and analyze the potential risks. Due to illiquidity, share prices can fall despite strong fundamentals and possible inability to raise sufficient additional cash to continue to fund ongoing operations is always a serious concern. Fuller details of risks associated with Sunshine Heart as identified by the company may be found with their form 10-12B/A registration filing with the SEC and their other SEC filings.

Disclosure: I am long SSH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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So You Have Some Questions About Sunshine Heart?

By Jake King

In May, following a $14M equity financing, PropThink outlined why Sunshine Heart (SSH) was an attractive opportunity at less than $6.00 per share and a $60M valuation. Namely the pricing disparity between Sunshine Heart and competing, larger LVAD players offers a clear picture of what Sunshine Heart might look like in five years. You can read the full article here. Additionally, earlier this month we laid out why we're still bullish on SSH following the company's first-ever quarterly conference call, here. Sunshine Heart has a number of catalysts upcoming, despite what looks like a relatively quiet few years as the company awaits key trial results from a domestic study of the C-Pulse device.

Considering the precipitous climb in Sunshine Heart's share price and increasing attention from the healthcare investing community in the last two months, PropThink.com is orchestrating an exclusive conference call and interview with Sunshine Heart Chief Executive Officer David Rosa for the afternoon of September 3rd. Much has been written about Sunshine Heart in the past month, and as with any rapidly appreciating healthcare stock, questions about the underlying technology and business have begun to materialize. Facilitating access to management for an oft-overlooked investing community - retail investors - is one of our goals at PropThink, thus this upcoming conference call will be structured around an open Q&A with Mr. Rosa - interested investors are invited to participate free of cost. Sunshine Heart has been a major win for PropThink since we suggested investors pick up shares around $5.25 in May of this year. SSH opened trading on Friday at $11.01 after hitting a new 52-week high of $13.80 on the 26th. Nevertheless, we continue to like the long-term potential in Sunshine Heart - at $130M, we believe the small company is still attractive in relation to its long-term prospects.

Sunshine Heart takes a novel approach to the treatment of late-stage heart failure in the development of its lead heart assist device, the C-Pulse system, which may mitigate the need for heart replacement surgery in patients with congestive heart failure. Unlike competing products developed by incumbents Thoratec (THOR) and Heartware (HTWR), Sunshine Heart's approach brings a much less invasive product, both in terms of surgical installation and function, to an ailing patient population. While most Left Ventricular Assist Devices (LVADs) used in late-stage heart failure patients improve heart function with a small, constant-flow or pulsatile impeller installed within the patient's bloodstream, the C-Pulse uses a thumbprint-sized balloon and cuff wrapped around the aorta to improve blood flow and reduce burden on the failing heart. With no direct blood contact, C-Pulse may eliminate the need for chronic anticoagulants and antiplatelets in this patient population - and reduce the occurrence of strokes. Furthermore, Sunshine Heart is tackling an unmet market in Stage III heart failure patients, those at risk of progressing to the final and most severe stage of the disease, Class IV. Study results to date indicate that Sunshine Heart's approach may be an ideal methodology.

Sunshine Heart has made significant progress in developing its lead product candidate since (and arguably because) Mr. Rosa joined the small company in 2009. C-Pulse IPO'd in 2004 on the Australian Securities Exchange (ASX), but progress at the firm had been disappointingly slow following a feasibility trial that began enrolling five years after the IPO, in 2009, had initiated just four of 20 planned patients when Rosa joined the company in October of the same year. Twelve months later, 16 patients had been implanted with the new device and SSH was well on its way to completing the design of a smaller external driver and powersource for the C-Pulse. By the time the company listed on the NASDAQ early in 2012, the company had compelling results from its small feasibility study in hand and was preparing for a sizable trial to begin in the U.S. The 388-patient COUNTER-HF trial, which began enrolling patients earlier this year, is designed to establish C-Pulse's safety and efficacy in a large population of Class III and IVa patients ahead of a Premarket Approval Application with the U.S. Food and Drug Administration. Likewise, C-Pulse was granted a CE Mark in Europe, and a 50-patient open-label trial was initiated this year.

Mr. Rosa joined Sunshine Heart in '09 from a position as President and CEO of Milksmart, a privately held agricultural technology firm. But Mr. Rosa's management background has centered predominantly on the cardiovascular medical device space. Prior to his time at Milksmart, Rosa spent four years as VP of Global Marketing for Cardiac Surgery and Cardiology at St. Jude Medical (STJ), and as CEO of the privately held A-Med Systems, a company that designs devices for acute heart failure. Likewise, from '95-'99 he held varying managerial positions at SCIMED Life Systems, another cardiovascular-centric and privately held company that was acquired by Boston Scientific in 1994, where it continues to operate as a subsidiary.

We invite investors to participate in this exclusive conference call with Mr. Rosa on Tuesday, September 3rd, at 3:00PM EDT. Mr. Rosa will offer his insight on the C-Pulse system and Sunshine Heart in a guided interview before the call is turned over to participants for an open Q&A. Details and free registration can be found at Propthink.com/SunshineHeartCall, or by clicking here.

Questions about the event can be directed to editor@propthink.com.

Disclosure: I am long SSH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: PropThink is a team of editors, analysts, and writers. This article was written by Jake King. We did not receive compensation for this article, and we have no business relationship with any company whose stock is mentioned in this article. Use of PropThink’s research is at your own risk. You should do your own research and due diligence before making any investment decision with respect to securities covered herein. You should assume that as of the publication date of any report or letter, PropThink, LLC and persons or entities with whom it has relationships (collectively referred to as "PropThink") has a position in all stocks (and/or options of the stock) covered herein that is consistent with the position set forth in our research report. Following publication of any report or letter, PropThink intends to continue transacting in the securities covered herein, and we may be long, short, or neutral at any time hereafter regardless of our initial recommendation. To the best of our knowledge and belief, all information contained herein is accurate and reliable, and has been obtained from public sources we believe to be accurate and reliable, and not from company insiders or persons who have a relationship with company insiders. Our full disclaimer is available at www.propthink.com/disclaimer.

View the original article here

So You Have Some Questions About Sunshine Heart?

By Jake King

In May, following a $14M equity financing, PropThink outlined why Sunshine Heart (SSH) was an attractive opportunity at less than $6.00 per share and a $60M valuation. Namely the pricing disparity between Sunshine Heart and competing, larger LVAD players offers a clear picture of what Sunshine Heart might look like in five years. You can read the full article here. Additionally, earlier this month we laid out why we're still bullish on SSH following the company's first-ever quarterly conference call, here. Sunshine Heart has a number of catalysts upcoming, despite what looks like a relatively quiet few years as the company awaits key trial results from a domestic study of the C-Pulse device.

Considering the precipitous climb in Sunshine Heart's share price and increasing attention from the healthcare investing community in the last two months, PropThink.com is orchestrating an exclusive conference call and interview with Sunshine Heart Chief Executive Officer David Rosa for the afternoon of September 3rd. Much has been written about Sunshine Heart in the past month, and as with any rapidly appreciating healthcare stock, questions about the underlying technology and business have begun to materialize. Facilitating access to management for an oft-overlooked investing community - retail investors - is one of our goals at PropThink, thus this upcoming conference call will be structured around an open Q&A with Mr. Rosa - interested investors are invited to participate free of cost. Sunshine Heart has been a major win for PropThink since we suggested investors pick up shares around $5.25 in May of this year. SSH opened trading on Friday at $11.01 after hitting a new 52-week high of $13.80 on the 26th. Nevertheless, we continue to like the long-term potential in Sunshine Heart - at $130M, we believe the small company is still attractive in relation to its long-term prospects.

Sunshine Heart takes a novel approach to the treatment of late-stage heart failure in the development of its lead heart assist device, the C-Pulse system, which may mitigate the need for heart replacement surgery in patients with congestive heart failure. Unlike competing products developed by incumbents Thoratec (THOR) and Heartware (HTWR), Sunshine Heart's approach brings a much less invasive product, both in terms of surgical installation and function, to an ailing patient population. While most Left Ventricular Assist Devices (LVADs) used in late-stage heart failure patients improve heart function with a small, constant-flow or pulsatile impeller installed within the patient's bloodstream, the C-Pulse uses a thumbprint-sized balloon and cuff wrapped around the aorta to improve blood flow and reduce burden on the failing heart. With no direct blood contact, C-Pulse may eliminate the need for chronic anticoagulants and antiplatelets in this patient population - and reduce the occurrence of strokes. Furthermore, Sunshine Heart is tackling an unmet market in Stage III heart failure patients, those at risk of progressing to the final and most severe stage of the disease, Class IV. Study results to date indicate that Sunshine Heart's approach may be an ideal methodology.

Sunshine Heart has made significant progress in developing its lead product candidate since (and arguably because) Mr. Rosa joined the small company in 2009. C-Pulse IPO'd in 2004 on the Australian Securities Exchange (ASX), but progress at the firm had been disappointingly slow following a feasibility trial that began enrolling five years after the IPO, in 2009, had initiated just four of 20 planned patients when Rosa joined the company in October of the same year. Twelve months later, 16 patients had been implanted with the new device and SSH was well on its way to completing the design of a smaller external driver and powersource for the C-Pulse. By the time the company listed on the NASDAQ early in 2012, the company had compelling results from its small feasibility study in hand and was preparing for a sizable trial to begin in the U.S. The 388-patient COUNTER-HF trial, which began enrolling patients earlier this year, is designed to establish C-Pulse's safety and efficacy in a large population of Class III and IVa patients ahead of a Premarket Approval Application with the U.S. Food and Drug Administration. Likewise, C-Pulse was granted a CE Mark in Europe, and a 50-patient open-label trial was initiated this year.

Mr. Rosa joined Sunshine Heart in '09 from a position as President and CEO of Milksmart, a privately held agricultural technology firm. But Mr. Rosa's management background has centered predominantly on the cardiovascular medical device space. Prior to his time at Milksmart, Rosa spent four years as VP of Global Marketing for Cardiac Surgery and Cardiology at St. Jude Medical (STJ), and as CEO of the privately held A-Med Systems, a company that designs devices for acute heart failure. Likewise, from '95-'99 he held varying managerial positions at SCIMED Life Systems, another cardiovascular-centric and privately held company that was acquired by Boston Scientific in 1994, where it continues to operate as a subsidiary.

We invite investors to participate in this exclusive conference call with Mr. Rosa on Tuesday, September 3rd, at 3:00PM EDT. Mr. Rosa will offer his insight on the C-Pulse system and Sunshine Heart in a guided interview before the call is turned over to participants for an open Q&A. Details and free registration can be found at Propthink.com/SunshineHeartCall, or by clicking here.

Questions about the event can be directed to editor@propthink.com.

Disclosure: I am long SSH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: PropThink is a team of editors, analysts, and writers. This article was written by Jake King. We did not receive compensation for this article, and we have no business relationship with any company whose stock is mentioned in this article. Use of PropThink’s research is at your own risk. You should do your own research and due diligence before making any investment decision with respect to securities covered herein. You should assume that as of the publication date of any report or letter, PropThink, LLC and persons or entities with whom it has relationships (collectively referred to as "PropThink") has a position in all stocks (and/or options of the stock) covered herein that is consistent with the position set forth in our research report. Following publication of any report or letter, PropThink intends to continue transacting in the securities covered herein, and we may be long, short, or neutral at any time hereafter regardless of our initial recommendation. To the best of our knowledge and belief, all information contained herein is accurate and reliable, and has been obtained from public sources we believe to be accurate and reliable, and not from company insiders or persons who have a relationship with company insiders. Our full disclaimer is available at www.propthink.com/disclaimer.

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Personalized drug dosing necessary for older heart patients

Main Category: Cardiovascular / Cardiology
Also Included In: Seniors / Aging;  Heart Disease
Article Date: 20 Aug 2013 - 0:00 PDT Current ratings for:
Personalized drug dosing necessary for older heart patients

Older heart patients present unique challenges for determining the optimal dosages of medications, so a new study from researchers at Duke Medicine offers some rare clarity about the use of drugs that are used to treat patients with heart attacks.

For certain heart patients older than age 75, a half-dose of the anti-platelet drug prasugrel works about as well as the typical dosage of clopidogrel, according to a team led by the Duke Clinical Research Institute that looked at a sub-study of a large clinical trial.

"As people live longer throughout the world, it's increasingly important to establish appropriate treatments for conditions such as acute coronary syndromes that commonly occur later in life," said Matthew T. Roe, M.D., MHS, associate professor of medicine at Duke and lead author of a study published Aug. 20, 2013, in the journal Circulation.

"These patients are very vulnerable to side effects, including bleeding, if therapies are not properly dosed," Roe said. "Additionally, existing practice guidelines have few specific recommendations for older patients with acute coronary syndromes as little evidence has been accrued from prior clinical trials in this population."

People older than age 75 comprise less than 10 percent of the U.S. population, but account for 35 percent of patients with acute coronary syndrome (ACS), which includes a recent heart attack or unstable chest pain. ACS is typically treated with anti-platelet therapies.

Earlier studies, for example, had shown that the platelet inhibitor prasugrel reduced the risk of adverse outcomes compared with clopidogrel in ACS patients undergoing coronary stent implantation. Those studies used a 60-mg initial dose followed by a 10-mg/day maintenance dose.

At that dosage level, however, patients older than age 75 had an increased risk of intracranial and fatal bleeding, as did younger patients weighing 132 pounds or less. The results led to warnings by the U.S. Food and Drug Administration and the European Medicines Agency for the use of the 10 mg/day maintenance dose of prasugrel in those populations, and consideration of a reduced dose (5 mg/day) to mitigate bleeding complications.

To examine whether older patients might benefit from a lower dosage of prasugrel, the Duke-led researchers analyzed more than 2,000 older patients who participated in a large trial called TRILOGY ACS that compared prasugrel with clopidogrel to manage acute coronary syndromes without coronary stent implantation or coronary bypass surgery.

The findings from this study, the first long-term data on outcomes specifically from elderly patients treated with the reduced dose of prasugrel, determined that a smaller dosage of 5-mg/day of prasugrel presented no greater risk of bleeding problems than the commonly prescribed 75-mg dose of clopidogrel in the elderly population.

"The findings from our study indicate how difficult it is to identify the right dose of anti-clotting medications for the elderly, to improve outcomes after a heart attack," said co-author Magnus Ohman, professor of medicine at Duke and chairman of the TRILOGY ACS study. "While a lower dose seemed intuitive, it was safe but not more effective. Future dedicated studies need to continue to find the right therapies for the vulnerable elderly patients."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cardiovascular / cardiology section for the latest news on this subject.

The Association of Early Physician Follow-up and 30-Day Readmission after Non-ST-Segment Elevation Myocardial Infarction among Older Patients

In addition to Roe and Ohman, study authors include Shaun Goodman; Susanna Stevens; Judith Hochman; Shmuel Gottlieb; Bikur Cholim; Felipe Martinez; Anthony Dalby; William Boden; Harvey White; Dorairaj Prabhakaran; Kenneth Winters; Philip Aylward; Jean-Pierre Bassand; Darren McGuire; Diego Ardissino; Keith A.A. Fox; and Paul Armstrong. CIRCULATIONAHA.113.004569; Published online before print August 14, 2013, doi: 10.1161/?CIRCULATIONAHA.113.004569

The drug companies Eli Lilly and Daiichi Sankyo, which market and make prasugrel, funded the TRILOGY ACS study.

Roe receives grant funding and/or consulting fees from Lilly and Daiichi Sankyo. Ohman receives grant funding and travel expenses from the Lilly and Daiichi Sankyo. More detailed disclosures are provided in the published study.

Duke University Medical Center

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Physician continuity after patients leave hospital for heart failure can help survival rates

Main Category: Primary Care / General Practice
Also Included In: Cardiovascular / Cardiology
Article Date: 19 Aug 2013 - 9:00 PDT Current ratings for:
Physician continuity after patients leave hospital for heart failure can help survival rates

Patients with heart failure who see a physician in the first month after leaving hospital are more likely to survive than those who do not see a doctor, reports a new study in CMAJ (Canadian Medical Association Journal). The effect is slightly more pronounced in patients who see their regular physician rather than an unfamiliar physician.

In the United States and Canada, more than $20 billion is spent every year on patients who are readmitted to hospital within 30 days after discharge. Heart failure is one of the most common reasons for hospitalization and has a high risk of readmission and early death.

To determine whether continuity of care resulted in better outcomes for patients with heart failure, researchers looked at data on all adults aged 20 years and over in Alberta who were discharged after hospitalization for heart failure. Patients were elderly with various health issues and had used the health care system in the year before their hospitalization for heart failure.

"Intuitively, one might consider physician continuity important for heart-failure patients discharged from hospital, given their age, high comorbidity burdens and complex therapy regimens," writes Dr. Finlay McAlister, University of Alberta, Edmonton, with coauthors. "However, a robust evidence base and multiple guidelines with consistent messaging on key management principles have made physician continuity potentially less important."

Of the total 24 373 discharged patients, 5336 (22%) did not see a physician within the first month, 16 855 (69%) saw a familiar physician (one they had seen at least twice in the year prior) and 2182 (9%) saw an unfamiliar physician. The researchers found that patients who saw a familiar physician had a lower risk of urgent readmission and death compared with patients who saw an unfamiliar physician or who did not visit a doctor.

"Early follow-up was associated with a lower risk of death or urgent readmission over 6 months, compared with no visits in the first month after discharge, regardless of whether the follow-up was with familiar or unfamiliar physicians. However, when we examined follow-up patterns throughout the 6 months after discharge, continuity with a familiar physician was associated with a significantly lower risk of death or readmission than follow-up with an unfamiliar physician, with similar effect estimates for specialist and nonspecialist follow-up," the authors write.

"The absolute reduction of 3% to 8% in risk of death or urgent readmission ... observed over 3?"12 months in association with follow-up in the first month after discharge was in the same range as the absolute benefits seen in placebo-controlled randomized trials of angiotensin-converting-enzyme inhibitor or b-blocker therapy. ... Thus, we believe that physicians should strive to optimize continuity with their heart-failure patients after discharge and that strategies are needed in the health care system to ensure early follow-up after discharge with the patient's regular physician," the authors conclude.

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Safer heart surgery from humble blood pressure cuff

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Academic Journal
Main Category: Surgery
Also Included In: Cardiovascular / Cardiology
Article Date: 16 Aug 2013 - 8:00 PDT Current ratings for:
Safer heart surgery from humble blood pressure cuff

Scientists have discovered that inflating a blood pressure cuff on the upper arm immediately prior to heart bypass surgery could decrease risk of heart injury and increase long-term survival rate.

According to the US Centers for Disease Control and Prevention (CDC), around 395,000 coronary artery bypass graft surgeries were carried out in the US in 2010.

Heart surgery, such as coronary bypass, can often cause heart muscle damage, the researchers say. It is linked to reduced long-term survival and can cause severe health outcomes such as heart attacks.

Researchers from the University School of Medicine, Essen, Germany, analyzed the effects of a procedure called remote ischemic preconditioning on 162 patients scheduled to undergo coronary artery bypass graft surgery.

A control group of 167 patients undergoing heart surgery who did not have remote ischemic preconditioning were also monitored.

Remote ischemic preconditioning is a procedure that involves temporarily cutting off the blood supply, then restoring it to an area away from the heart.

The study, published in the The Lancet, looked at whether this procedure affects long-term survival following bypass surgery, and whether it has effects on other health issues, such as stroke and heart attack.

Blood pressure cuff: blood flow of the heart bypass patients was restricted before surgery by simple use of a sphygmomanometer

The patients undergoing remote ischemic preconditioning were:

Anesthetized prior to surgery and had their blood flow restricted for 5 minutes with a standard blood pressure cuff, which was inflated on their upper left arm.They then had their blood supply restored for 5 minutes as the cuff deflated.This procedure was repeated three times.

Following the surgery, the patients' blood concentrations of a substance called troponin 1 was measured. This substance is a biomarker protein that reveals any damage to the heart muscle. A higher concentration of troponin 1 means extensive damage has occurred.

Additionally, the patients were monitored for up to 4 years after surgery in order to see whether remote ischemic preconditioning had any effects on their long-term health.

Results of the study showed that patients who had remote ischemic preconditioning had troponin 1 levels 17% lower compared with those who did not undergo the treatment 72 hours after surgery.

One year after surgery, the findings showed that: Patients who had remote ischemic preconditioning were 73% less likely to have died of any cause compared with patients who did not have the treatment.They were also 86% less likely to die from a stroke or heart attack.

Professor Gerd Heusch of the Institute of Pathophysiology at the University School of Medicine, says:

"The results of our study are very encouraging that remote ischemic preconditioning not only reduces heart muscle injury but also improves long-term health outcomes for heart bypass patients."

The study authors say that it was already common knowledge that remote ischaemic preconditioning helps reduce injury to heart muscle, but they add that this study is the first randomized control trial to provide evidence that the procedure encourages longer survival in coronary bypass patients.

"The beauty of remote ischemic preconditioning is that it is non-invasive, simple, cheap, and safe," said Dr. Matthias Thielmann of the department of thoracic and cardiovascular surgery at the university.

"This procedure could be a promising and simple strategy to protect patients' heart muscle during surgery and hopefully improve health outcomes after surgery," he said.

But in a comment piece at the end of the study, Professor Michel Ovize of the Louis Pradel Hospital in France says that although this research highlights the benefits of remote ischemic preconditioning directly related to the heart, he believes the findings show the potential of possibilities beyond that.

"The incidence of non-heart-related events, such as sepsis or stroke, was lower in the remote ischemic preconditioning group than in the control group, albeit of few events overall," said Prof. Ovize.

"These findings suggest that the effect on the heart might be only one aspect of a much wider effect, and that remote conditioning, unlike local conditioning, might lead to persistent protection."

Written by Honor Whiteman

Copyright: Medical News Today
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Decellularized mouse heart beats again after regeneration with human heart precursor cells in Pitt project

Main Category: Cardiovascular / Cardiology
Also Included In: Biology / Biochemistry
Article Date: 15 Aug 2013 - 2:00 PDT Current ratings for:
Decellularized mouse heart beats again after regeneration with human heart precursor cells in Pitt project

For the first time, a mouse heart was able to contract and beat again after its own cells were stripped and replaced with human heart precursor cells, said scientists from the University of Pittsburgh School of Medicine. The findings, reported online in Nature Communications, show the promise that regenerating a functional organ by placing human induced pluripotent stem (iPS) cells - which could be personalized for the recipient - in a three-dimensional scaffold could have for transplantation, drug testing models and understanding heart development.

In the United States, one person dies of heart disease every 34 seconds, and more than 5 million people suffer from heart failure, meaning a reduced ability to pump blood, said senior investigator Lei Yang, Ph.D., assistant professor of developmental biology, Pitt School of Medicine. More than half of heart disease patients do not respond to current therapies and there is a scarcity of donor organs for transplant.

"Scientists have been looking to regenerative medicine and tissue engineering approaches to find new solutions for this important problem," Dr. Yang said. "The ability to replace a piece of tissue damaged by a heart attack, or perhaps an entire organ, could be very helpful for these patients."

For the project, the research team first "decellularized," or removed all the cells, from a mouse heart, a process that takes about 10 hours using a variety of agents. Then, they repopulated the remaining heart framework, or scaffold, with multipotential cardiovascular progenitor (MCP) cells. These replacement cells were produced by reverse engineering fibroblast cells from a small skin biopsy to make induced pluripotent stem cells and then treating the iPS cells with special growth factors to further induce differentiation.

"This process makes MCPs, which are precursor cells that can further differentiate into three kinds of cells the heart uses, including cardiomyocytes, endothelial cells and smooth muscle cells," Dr. Yang explained. "Nobody has tried using these MCPs for heart regeneration before. It turns out that the heart's extracellular matrix - the material that is the substrate of heart scaffold - can send signals to guide the MCPs into becoming the specialized cells that are needed for proper heart function."

After a few weeks, the mouse heart had not only been rebuilt with human cells, it also began contracting again, at the rate of 40 to 50 beats per minute, the researchers found. More work must be done to make the heart contract strongly enough to be able to pump blood effectively, and to rebuild the heart's electrical conduction system correctly so that the heart rate speeds up and slows down appropriately.

In the future, it might be possible to take a simple skin biopsy from a patient to derive personalized MCPs that can be used to seed a biologic scaffold and regenerate a replacement organ suitable for transplantation, Dr. Yang noted. The model also could be used as a lab-based method to preclinically test the effect of new drugs on the heart or to study how the fetal heart might develop.

"One of our next goals is to see if it's feasible to make a patch of human heart muscle," he added. "We could use patches to replace a region damaged by a heart attack. That might be easier to achieve because it won't require as many cells as a whole human-sized organ would."

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Visit our cardiovascular / cardiology section for the latest news on this subject.

The project was funded by the University of Pittsburgh, the American Heart Association, and the National Science Council (Taiwan).

Repopulation of decellularized mouse heart with human induced pluripotent stem cell-derived cardiovascular progenitor cells

Nature Communications 4, Article number: 2307 doi:10.1038/ncomms3307

Tung-Ying Lu, Bo Lin, Jong Kim, Mara Sullivan, Kimimasa Tobita, Guy Salama & Lei Yang

University of Pittsburgh

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Cardiovascular researchers examine habits that can lead to obesity, future heart risk

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Pediatrics / Children's Health;  Heart Disease
Article Date: 14 Aug 2013 - 0:00 PDT Current ratings for:
Cardiovascular researchers examine habits that can lead to obesity, future heart risk

Among middle-school children, the behaviors most often linked with obesity are school lunch consumption and two hours or more of daily TV viewing, according to a new look at the dramatic increase in childhood obesity.

The findings by the University of Michigan Frankel Cardiovascular Center will be published in the September issue of Pediatrics.

While some habits were the same for all overweight and obese children, the study found some gender differences in the habits influencing body weight.

Data from 1,714 sixth grade students enrolled in Project Healthy Schools showed girls who drank two servings of milk each day were less likely to be obese, and boys who played on a sports team were also at a healthier weight.

"Additional work is needed to help us understand the beneficial impact of improving school lunches and decreasing screen time," says cardiologist and senior study author Elizabeth Jackson, M.D., M.P.H., assistant professor of internal medicine at the University of Michigan Medical School. "Presumably playing video games, or watching TV replaces physical activity."

Students enrolled in sixth grade at 20 schools in the southeastern Michigan communinities of Detroit, Ann Arbor, Ypsilanti and Owosso were eligible for participation in this study. The median age was 11.

Obese boys and girls had poor cardiovascular profiles with lower HDL-cholesterol, higher triglycerides, higher blood pressure and higher heart rate recovery - indicating a lower level of fitness - compared to normal weight kids.

"Cardiovascular disease doesn't just start in adulthood, and there may be factors that could help us identify during youth or adolescence who might be at increased risk for developing health problems later on," Jackson says.

Other studies have linked eating school lunch with obesity, but a major issue with such studies, Jackson says, is the influence of socioeconomic status. Poor children eligible for free or reduced school lunch may already be overweight, considering the link between obesity and lower socioeconomic status.

"Although we were not able to examine the specific nutritional content of school lunches, previous research suggests school lunches include nutrient-poor and calorie-rich foods," Jackson says.

The University of Michigan study adds a new element in the fight to reduce childhood obesity by providing a real-world view of the gender differences in obesity risk factors.

Milk consumption seemed to protect girls from obesity, but made no difference for boys. A possible explanation would be a reduction in sugary drinks, which girls replaced with milk.

In the study, 61 percent of obese boys and 63 percent of obese girls reported watching television for two or more hours a day. The assumption is watching television mediates physical activity, but there were gender differences in how children spent their so-called "screen time."

When asked, obese girls were more likely than any other group to use a computer. Obese boys reported playing video games more often than normal weight boys, although the association was not as strong as in other studies.

"We did not find a significant association between time spent playing video games and obesity among boys, which has been observed in other studies," says study lead author Morgen Govindan, an investigator with the Michigan Cardiovascular Research and Reporting Program at the U-M. "Although we saw a similar trend, the association was not as strong perhaps due to our smaller sample size."

She adds: "Exploring such gender-related differences in a larger group may help in refining the interventions to promote weight loss and prevent obesity among middle school children."

The Project Healthy Schools program is designed to teach sixth graders heart-healthy lifestyles including eating more fruits and vegetables, making better beverage choices, engaging in 150 minutes of exercise per week, eating less fast food and less fatty foods, plus reducing time spent in front of computer and video game screens.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our obesity / weight loss / fitness section for the latest news on this subject.

Funding: Project Healthy Schools’ wellness efforts have been generously supported by a number of health systems, foundations, and individuals, including the University of Michigan Health System, the Thompson Foundation, the Hewlett Foundation, the Mardigian Foundation, the Memorial Healthcare Foundation, the William Beaumont Health System Foundation, the Robert C. Atkins Foundation, the Ann Arbor Area Community Foundation, the Allen Foundation, AstraZeneca HealthCare Foundation, Borders, Inc. and the Robert Beard Foundation.

Gender Differences in Physiologic Markers and Health Behaviors Associated With Childhood Obesity

Additional University of Michigan authors: Morgen Govindan; Roopa Gurm; Sathish Mohan; Eva Kline-Rogers, RN; Nicole Corriveau; Caren Goldberg, M.D.; Jean DuRussel-Weston, RN, M.P.H. and Kim A. Eagle, M.D. Pediatrics, Volume 132, Number 3, September 2013. Published online August 12, 2013. (doi: 10.1542/peds.2012-2994)

University of Michigan Health System

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Children of obese mothers at greater risk of early heart death as adults

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Cardiovascular / Cardiology
Article Date: 14 Aug 2013 - 0:00 PDT Current ratings for:
Children of obese mothers at greater risk of early heart death as adults

Children of obese and overweight women have a higher risk of early cardiovascular death as adults, finds a study published on bmj.com.

The findings highlight the urgent need for strategies to prevent obesity in women of childbearing age and the need to assess the offspring of obese mothers for their cardiovascular risk, say the authors.

Rates of maternal obesity have risen rapidly in the past two decades. In the United States, about 64% of women of reproductive age are overweight and 35% are obese, with a similar pattern in Europe.

Many studies have shown a link between maternal obesity and disease later in life, but it is still not clear whether maternal obesity is associated with increased death in offspring from cardiovascular causes.

Using birth and death records from 1950 to the present day, a team of researchers from the Universities of Edinburgh and Aberdeen in Scotland identified 28,540 women - whose body mass index (BMI) was recorded at their first antenatal visit - and their 37,709 offspring who were aged between 34 and 61 at the time of follow up.

BMI was defined as underweight (BMI 18.5 or less), normal weight (BMI 18.5-24.9), overweight (BMI 25-29.9), and obese (BMI 30 or more).

Relevant details about the pregnancy were collated, including the mother's age at delivery, number of previous pregnancies, mother and father's social class and infant sex, birth weight and gestation at delivery.

Among the mothers, 21% were overweight and 4% were obese. Among the 37,709 offspring there were 6551 premature deaths from any cause and, among the deceased, 294 had had obese mothers at birth.

The researchers found that the risk of premature death was 35% higher in the adult offspring of obese mothers compared to those whose mothers had had normal weight. This was after adjusting the results for factors including the mother's age at delivery, number of previous pregnancies, mother and father's social class and infant sex, birth weight and gestation at delivery.

They also found a 42% increased risk (adjusted for the same factors) of a hospital admission for a cardiovascular event in the adult offspring of obese mothers compared with offspring of mothers with normal BMI.

The offspring of overweight mothers also had a higher risk of adverse events later in life.

It is thought that being overweight in pregnancy may cause permanent changes in appetite control and energy metabolism in the offspring, leading to a greater risk of heart problems later in life.

With rising rates of excess weight among pregnant women, the authors say their findings are "a major public health concern" and indicate that the offspring of obese mothers are a high risk group who should be assessed for cardiovascular risk, and actively encouraged to maintain a healthy lifestyle.

"As one in five women in the UK is currently obese at antenatal booking, strategies to optimise weight before pregnancy are urgently required," they conclude.

Dr Sohinee Bhattacharya, of the University of Aberdeen, said: "This study highlights the importance of weight management in mothers and their offspring. We need to find out how to help young women and their children control their weight better so that chronic disease risk is not transmitted from generation to generation."

Jacqui Clinton, Health Campaigns Director at Tommy's, said: "This new study adds to a growing body of evidence that obesity during pregnancy can have a long term impact on children, affecting their adult weight, health and even their life expectancy. If we are to tackle obesity in the UK, we need to start at conception and help mums to limit the impact of their weight on their babies - research shows that eating a healthy diet and taking moderate exercise while pregnant can make a big difference. Looking after a baby's health while in the womb may not only increase the chances of a healthy birth, but of a longer, healthier life."

In an accompanying editorial, Dr Factor-Litvak from the Department of Epidemiology in New York, says that this study leaves open two questions. Firstly, what is the role of the early post natal environment and secondly, what is the role of parental obesity? She asks what the implications of the study are, concluding that along with recommended weight gain for overweight and obese women, "interventions should begin before pregnancy".

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Earlier surgical correction of heart valve disorder associated with greater long-term survival, lower risk of heart failure risk

Main Category: Cardiovascular / Cardiology
Article Date: 13 Aug 2013 - 13:00 PDT Current ratings for:
Earlier surgical correction of heart valve disorder associated with greater long-term survival, lower risk of heart failure risk

In a study that included patients with mitral valve regurgitation due to a condition known as flail mitral valve leaflets, performance of early surgical correction compared with initial medical management was associated with greater long-term survival and lower risk of heart failure, according to a study in the August 14 issue of JAMA.

"Degenerative mitral regurgitation [backflow of blood from the left ventricle to the left atrium due to mitral valve insufficiency] is common and can be surgically repaired in the vast majority of patients, improving symptoms and restoring normal life expectancy. Despite the safety and efficacy of contemporary surgical correction, an ongoing international debate persists regarding the need for early intervention in patients without American College of Cardiology (ACC)/American Heart Association (AHA) guideline class I triggers (no or minimal symptoms and absence of left ventricular dysfunction). This is in part propagated by discordant views of the prognostic consequences of uncorrected severe mitral regurgitation; considered as benign by those supporting medical watchful waiting (nonsurgical observation until a distinct event is encountered) vs. conveying excess mortality and morbidity (including heart failure and atrial fibrillation) by those advocating early surgical intervention," according to background information in the article.

To understand the comparative effectiveness of early surgery vs. initial medical management strategies, Rakesh M. Suri, M.D., D.Phil., of the Mayo Clinic College of Medicine, Rochester, Minn., and colleagues conducted a study to ascertain the comparative effectiveness of initial medical management (nonsurgical observation) vs. early mitral valve surgery following the diagnosis of mitral regurgitation due to flail leaflets (an abnormality of the mitral valve in which a portion of the valve has lost its normal support). For the study, the researchers used data from the Mitral Regurgitation International Database (MIDA) registry, which includes 2,097 patients with flail mitral valve regurgitation (1980-2004) receiving routine cardiac care from 6 tertiary centers (France, Italy, Belgium, and the United States). Of 1,021 patients with mitral regurgitation without ACC and AHA guideline class I triggers, 575 patients were initially medically managed and 446 underwent mitral valve surgery within 3 months following detection.

Within 3 months following diagnosis, 8 patients died, 5 (1.1 percent) after early surgery vs. 3 (0.5 percent) during initial medical management; 9 patients developed heart failure, 4 (0.9 percent) after early surgery vs. 5 (0.9 percent) during initial medical management; and 30 patients developed new-onset atrial fibrillation, 6.2 percent after early surgery vs. 1.2 percent during initial medical management.

Ninety-eight percent of patients were followed up from diagnosis until death or at least 5 years. A total of 319 deaths were observed during an average follow-up time of 10.3 years. "Survival among the entire unmatched cohort for early surgery was 95 percent at 5 years, 86 percent at 10 years, 63 percent at 20 years vs. 84 percent at 5 years, 69 percent at 10 years, and 41 percent at 20 years for initial medical management, favoring early surgery," the authors write. Early surgical correction of mitral valve regurgitation was associated with a 5-year reduction in mortality of 53 percent.

With class II triggers (atrial fibrillation or pulmonary hypertension), survival was again better with early surgery, both overall and in the matched cohort at 10 years.

During follow-up, 167 patients incurred at least 1 incident episode of heart failure representing a rate of 16 percent at 10 years and 27 percent at 20 years. In the overall cohort, heart failure was less frequent after early surgery (7 percent for early surgery vs. 23 percent for initial medical management at 10 years and 10 percent for early surgery vs. 35 percent for initial medical management at 20 years), with a heart failure risk reduction of approximately 60 percent.

Reduction in late-onset atrial fibrillation was not observed.

"These findings emanate from institutions that together provide a very high rate of mitral valve repair (>90 percent) with low operative mortality, emphasizing that such results might also be achieved in routine practice at many advanced repair centers," the authors write. "The advantages associated with early surgical correction of mitral valve regurgitation were confirmed in both unmatched and matched populations, using multiple statistical methods."

In an accompanying editorial, Catherine M. Otto, M.D., of the University of Washington School of Medicine, Seattle, comments on how the findings of this study may influence patient care.

"The study group is atypical compared with most patients with chronic severe mitral regurgitation seen in clinical practice who are referred for surgical intervention at symptom onset or when serial imaging shows early left ventricular (LV) dysfunction. In patients with severe mitral regurgitation due to mitral valve prolapse, early surgery is reasonable if surgical risk is low and the likelihood of successful valve repair is high, which is often the case for patients with a flail leaflet; the new data support this recommendation."

"However, if surgical risk is high or if the likelihood of valve repair is low, it remains uncertain whether early surgical intervention is appropriate in the asymptomatic patient with severe mitral regurgitation due to a flail leaflet when LV size and systolic function are normal. Although the majority of these patients will develop clear indications for valve surgery within 2 years, it may be reasonable to postpone the risks of having an intervention and having a prosthetic valve as long as possible."

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Article - JAMA. 2013;310(6):609-616

Editorial - JAMA. 2013;310(6):587-588

JAMA

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Premature infants may have higher risk of heart disease

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Academic Journal
Main Category: Pregnancy / Obstetrics
Also Included In: Heart Disease
Article Date: 14 Aug 2013 - 8:00 PDT Current ratings for:
Premature infants may have higher risk of heart disease

Babies who are born prematurely experience differences in how their heart forms and works as an adult, compared with babies who are born at full-term. According to a study published in the journal Circulation, this leads to a higher risk of cardiovascular disease later in life.

Researchers from the University of Oxford in England studied 102 premature infants from birth, alongside 132 infants who were born at full-term with no complications.

Of the premature infants, 14% were born at less than 28 weeks, 58% were born between 28 and 31 weeks, and 31% were born between 32 and 36 weeks.

All infants were born in the 1980s and tracked until they were between 23 and 28 years of age.

As well as standard heart health evaluations, which included measurements of blood pressure and cholesterol, the researchers used magnetic resonance imaging (MRI) techniques in order to measure the participants' hearts and blood vessels.

They used computer programs to create models of the hearts, enabling them to investigate their structure and see how much blood was being pumped around the body.

Results of the analysis revealed that the right ventricle - the part of the heart that receives deoxygenated blood from the right atrium and pumps it to the lungs - was significantly different in the adults who were premature babies, compared with the hearts of adults who were born at full-term.

The premature babies had hearts that were smaller, heavier and had thicker walls with reduced pumping activity.

Additionally, the scientists found that the earlier the former premature babies were born, the bigger the impact was on the size and function of the right ventricle.

Professor Paul Leeson, a cardiologist at the Cardiovascular Clinical Research Facility of the University of Oxford, says that around 10% of today's adults are born prematurely and appear to be at higher risk of cardiovascular problems in adulthood.

He says:

"We wanted to understand why this occurs so that we can identify the small group of patients born premature who may need advice from their healthcare provider about this cardiovascular risk.

The changes we have found in the right ventricle are quite distinct and intriguing."

The scientists say that in older adults, changes in the structure of the right ventricle may lead to increased risk of heart failure and cardiovascular death.

But they add that there was no evidence of such problems in the young people who participated in the study.

The study authors conclude that further analysis is needed to enhance understanding of the structure of the hearts in premature babies, and how their risk of cardiovascular can increase in adulthood.

"We are trying to dig deeper into what's different about the hearts of those born preterm," says Adam Lewandowski, first author of the study.

"The potential scientific explanations for why their hearts are different are fascinating and our study adds to the growing understanding of how premature birth shapes future heart health."

Written by Honor Whiteman

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our pregnancy / obstetrics section for the latest news on this subject.

Right ventricular systolic dysfunction in young adults born preterm doi: 10.1161/ CIRCULATIONAHA.113.002583, published in the journal Circulation, 12 August 2013.

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Study identifies characteristics of heart failure patients more likely to benefit from implantation of cardiac resynchronization device

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 13 Aug 2013 - 13:00 PDT Current ratings for:
Study identifies characteristics of heart failure patients more likely to benefit from implantation of cardiac resynchronization device

In a large population of Medicare beneficiaries with heart failure who underwent implantation of a cardiac resynchronization therapy defibrillator, patients who had the cardiac characteristics of left bundle-branch block and longer QRS duration had the lowest risks of death and all-cause, cardiovascular, and heart failure readmission, according to a study in the August 14 issue of JAMA.

"Clinical trials have shown that cardiac resynchronization therapy (CRT) improves symptoms and reduces mortality and readmission among selected patients with heart failure and left ventricular systolic dysfunction. Following broad implementation of CRT, it was recognized that one-third to one-half of patients receiving the therapy for heart failure do not improve. Identification of patients likely to benefit from CRT is particularly important, because CRT defibrillator (CRT-D) implantation is expensive, invasive, and associated with important procedural risks. A primary question regarding optimal patient selection for CRT is whether patients with longer QRS duration or left bundle-branch block (LBBB) morphology derive greater benefit than others," according to background information in the article. QRS duration is a measurement of the electrical conducting time of the heart on an electrocardiogram. Left bundle-branch block is a cardiac conduction abnormality.

Pamela N. Peterson, M.D., M.S.P.H., of Denver Health Medical Center, Denver, and colleagues conducted a study to determine the long-term outcomes of patients undergoing CRT-D implantation and associations between combinations of QRS duration and presence of LBBB and outcomes, including all-cause mortality; all-cause, cardiovascular, and heart failure readmission; and complications. The study included Medicare beneficiaries in the National Cardiovascular Data Registry's ICD Registry between 2006 and 2009 who underwent CRT-D implantation. Patients were stratified according to whether they were admitted for CRT-D implantation or for another reason, then categorized as having either LBBB or no LBBB and QRS duration of either 150 ms or greater or 120 to 149 ms. Patients underwent follow-up for up to 3 years, through December 2011.

Mortality rates in the primary overall study cohort were 0.8 percent at 30 days, 9.2 percent at 1 year, and 25.9 percent at 3 years. Rates of all-cause readmission were 10.2 percent at 30 days and 43.3 percent at 1 year. The researchers found that after adjustment for demographic and clinical factors, compared with patients with LBBB and QRS duration of 150 ms or greater, the other 3 groups had significantly higher risks of mortality and all-cause, cardiovascular, and heart failure readmission. The adjusted risk of 3-year mortality was lowest among patients with LBBB and QRS duration of 150 ms or greater (20.9 percent), compared with LBBB and QRS duration of 120 to 149 ms (26.5 percent), no LBBB and QRS duration of 150 ms or greater (30.7 percent), and no LBBB and QRS duration of 120 to 149 ms (32.3 percent). The adjusted risk of l-year all-cause readmission were also lowest among patients with LBBB and QRS duration of 150 ms or greater (38.6 percent), compared with LBBB and QRS duration of 120 to 149 ms (44.8 percent), no LBBB and QRS duration of 150 ms or greater (45.7 percent), and no LBBB and QRS duration of 120 to 149 ms (49.6 percent).

There were no observed associations with complications.

"Although prior data regarding the effects of CRT as a function of QRS duration are largely limited to meta-analyses of clinical trials, this study provides an important perspective on the role of QRS duration in outcomes after CRT implantation in clinical practice," the authors write.

"These findings support the use of QRS morphology and duration to help identify patients who will have the greatest benefit from CRT-D implantation."

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Promising compound could offer new treatment for heart failure

Main Category: Cardiovascular / Cardiology
Article Date: 03 Aug 2013 - 0:00 PDT Current ratings for:
Promising compound could offer new treatment for heart failure

Heart failure occurs when the heart cannot pump enough blood to meet the body's needs. It's a very common condition, affecting about six million people in the United States, but current therapies are not adequately effective at improving health and preventing deaths. A study published by Cell Press August 1st in the journal Cell reveals the key role of a family of molecules known as bromodomain and extraterminal domain (BET) proteins in activating genes that contribute to heart failure. The study also demonstrates that a BET-inhibiting drug can protect against heart failure in mice, opening up promising new avenues for the treatment of this devastating condition.

"New insights into the biology of heart failure are desperately needed to prompt new types of targeted therapeutic agents," says senior study author James Bradner of the Dana-Farber Cancer Institute and Harvard Medical School. "Our findings comprise significant progress toward fulfilling this clinical need, which is great news for heart failure patients."

Heart failure is a debilitating condition that causes fatigue, shortness of breath, organ damage, and early death. It is triggered by the activation of a large set of genes that cause the walls of the heart to thicken and develop scar tissue, impairing the organ's ability to pump blood normally. BET proteins can have a huge impact on gene activity because they belong to a class of molecules called epigenetic readers, which recognize special marks on DNA-protein complexes and attract gene-activating proteins to those spots. Bradner and his collaborators recently developed a potent BET inhibitor called JQ1, which shows promise as a potential anticancer therapy. But until now, nothing was known about the role of BET proteins in heart function.

To address this question, Bradner teamed up with study senior author Saptarsi Haldar of Case Western Reserve University School of Medicine and University Hospitals Case Medical Center. They found that BET proteins regulate the growth of heart muscle cells and activate a broad set of genes involved in heart failure. Treatment with JQ1 inhibited this abnormal pattern of gene activity and protected against heart-wall thickening, the formation of scar tissue, and pump failure in a mouse model of cardiac disease.

"Based on our findings, we are highly motivated to bring a drug-like derivative of JQ1 forward as a new type of heart failure drug for humans," Haldar says. "These compounds will shortly enter the clinic for therapeutic development in cancer, and we expect they can also be immediately developed into therapies for heart failure."

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Cell, Anand et al.: "BET Bromodomains Mediate Transcriptional Pause Release in Heart Failure."

Cell Press

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Broken heart: Can grief damage your heart?

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Your grandfather passes away and your grandmother begins complaining of chest pain. Is there a connection? Some people, especially women age 50 and older, sustain heart injury after hearing bad news. It's known as broken heart syndrome. While people who have broken heart syndrome usually recover, play it safe. If a loved one complains of chest pain after a traumatic event, encourage him or her to seek emergency medical care.

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