Mills-Peninsula Health Services

Change of Heart: Sutter Health is Poised for New Era in Cardiology Care

Posted on Mar 29, 2019 in Affiliates, Alta Bates Summit Medical Center, California Pacific Medical Center, Carousel, Mills-Peninsula Health Services

BURLINGAME, Calif. — Change can be sudden or slow, in this case it’s both. Sutter Health has been at the forefront of a decade-long journey to offer more patients with aortic valve stenosis an alternative to open-heart surgery. With new research presented last week at one of the world’s top cardiology meetings that goal seems achievable almost overnight.

Aortic stenosis is a serious cardiac condition in which the aortic valve in the heart narrows, limiting blood flow to the body. Doctors can treat aortic stenosis by replacing the patient’s faulty valve either during open-heart surgery or through a minimally invasive procedure called TAVR (Transcatheter Aortic Valve Replacement).

David Daniels, M.D.

It is estimated that 100,000 TAVR procedures have been performed over the past decade, yet open-heart surgery remained the standard of care. “This meant that I could only offer TAVR if open-heart surgery would put my patient at an unnecessarily high risk for complications,” said interventional cardiologist David Daniels, M.D., co-director of Sutter’s Structural Heart Program in the Bay Area and a Sutter Health clinician-investigator.

Recently a major clinical trial[1] showed that a reversal may be in order; going forward TAVR may be the routine treatment or ‘gold standard’ for aortic stenosis, and open-heart surgery may be the exception.

Sutter Health not only participated in the recently completed trial, but under a continued access protocol, three Sutter Health hospitals are able to continue offering TAVR to a broader group of patients—even while the U.S. Food and Drug Administration examines the trial’s data.

The three Bay Area hospitals participating in the continued access protocol are: Mills-Peninsula Medical Center (Burlingame), California Pacific Medical Center (San Francisco), and Alta Bates Summit Medical Center (Oakland).

“I want to stress that TAVR is not a new procedure. I’ve successfully treated over 950 patients with this technique,” remarked Dr. Daniels. “The new part of this is that we can now offer TAVR, which is done through a small incision in the groin, to even more patients than before—giving them an option that is often safer, and often has a faster recovery time, than open-heart surgery.”

A typical hospital stay for open-heart surgery is a week to 10 days. TAVR patients often go home within 24 hours and are back to their usual activities within a few days instead of six weeks or longer for open-heart surgery patients.

Remarkable Clinical Trial Results 

Sutter Health’s cardiovascular teams have been involved with TAVR since its inception and have continued to pioneer the procedure as the artificial valves themselves have evolved. Over the years, several Sutter Health hospitals have participated in studies that confirmed the safety and efficacy of TAVR in patients who have intermediate or high risk of complication from open-heart surgery.

However, the most recent trial, called the PARTNER 3 trial, specifically looked at patients for whom open-heart surgery carries a relatively low risk of complications.[2]

Sutter Health affiliated combined sites Mills-Peninsula Medical Center (MPMC) and Alta Bates Summit Medical Center (ABSMC) were major contributors to the PARTNER 3 trial and the second largest enrollment site in the state (trailing Cedars-Sinai in Los Angeles). MPMC achieved a zero percent complication rate (one year post procedure) among its low risk patients who received TAVR as part of the trial. Sutter Medical Center Sacramento and Alta Bates Summit Medical Center also participated in the PARTNER 3 trial.

“The PARTNER 3 results are remarkable. There was a statistically significant 60 percent reduction in risk of death and stroke in TAVR compared to surgery, and this was carried out to one year,” Dr. Daniels remarked.

The study looked at rehospitalization associated with death, stroke or heart failure, and found that these negative results were 50 percent lower (half as likely) when the patient had TAVR instead of open-heart surgery. Beyond these results, there were significantly lower rates of renal failure, life threatening hemorrhage and reduced length of hospital stay among the patients in the TAVR group compared to the open-heart surgery patients.

The Future is Here

“Presently we are in the gap between the end of the PARTNER 3 trial and a decision by the FDA that might officially extend approval of TAVR to the low risk patient group,” explained Dr. Daniels. Today, the artificial valves used in the TAVR procedure are FDA-approved only for patients who are considered too old or frail to have open-heart surgery.

“We are proud to continue to offer the TAVR procedure to low risk patients as part of our participation in the valve manufacturer’s continued access protocol.” Three Sutter Health hospitals: Mills-Peninsula Medical Center, California Pacific Medical Center and Alta Bates Summit Medical Center — are the only facilities in Northern California currently participating in the continued access protocol.

“Common sense told us that even patients with a low risk of complications from open-heart surgery may benefit significantly from treatment with TAVR instead,” Dr. Daniels said. “Results from the PARTNER 3 trial indicate that, for many patients, this has proven to be true. We are pleased to be able to offer TAVR to all patient risk groups.”

These groundbreaking clinical results are an example of how Sutter Health is leading the transformation of healthcare. If you are suffering from severe aortic valve stenosis talk to your cardiologist to see if valve replacement with TAVR is right for you.

[1] Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019 Mar 17. doi: 10.1056/NEJMoa1814052. [Epub ahead of print]

[2] The PARTNER 3 trial was sponsored by the makers of the Sapien artificial valve, Edwards Lifesciences of Irvine, Calif. Dr. Daniels is a consultant for Edwards Lifesciences.

Your Gifts Help Us Bring the Emergency Department to the Patient

Posted on Mar 20, 2019 in Expanding Access, Innovation, Mills-Peninsula Health Services, Quality, Research, Scroll Images

Stroke is the fifth leading cause of death in the U.S. and the leading cause of adult disability, affecting 800,000 people a year. Time is critical for people who experience a stroke—every minute saves 2 million brain cells.

 

Every minute counts when treating a patient who has had a stroke. Donor support for the Mobile Stroke Unit gives us the tools to help ensure that patients in our community not only survive, but also avoid the debilitating effects of a stroke. Through a research trial this project will also help to inform best practices in stroke treatment nationwide —impacting the care of thousands.

The Mills-Peninsula Hospital Foundation has launched a $2.4 million fundraising campaign to underwrite the cost of operating the Unit for the first 2 years, while a randomized controlled trial is conducted to gauge the effectiveness of the program compared to conventional care.

Invest in the Mobile Stroke Unit.

Preliminary studies have indicated that a Mobile Stroke Unit can reduce the time from ambulance dispatch to treatment to as little as 11 minutes. Sutter Health affiliated Mills-Peninsula Medical Center is the only hospital in Northern California and one of only two hospitals in the state to have a Mobile Stroke Unit.

Research at Sutter Health Shows New Treatment Approach Improves Survival, Reduces Metastasis in High-Risk Prostate Cancer

Posted on Mar 20, 2019 in Affiliates, Alta Bates Summit Medical Center, California Pacific Medical Center, Innovation, Mills-Peninsula Health Services, Palo Alto Medical Foundation, Research, Scroll Images, Sutter Auburn Faith Hospital, Sutter Medical Foundation

SAN FRANCISCO – Prostate cancer impacts one in every nine men in the U.S. Although death rates from the disease have declined over the last two decades, over 25,000 men die from prostate cancer annually.

Docetaxel, a chemotherapy drug commonly used to treat other types of cancer, has improved overall survival with limited toxicity in men whose prostate cancers have metastasized and who are no longer sensitive to androgen suppression therapy (i.e., patients are hormone resistant).

Researchers at Sutter Health and other leading centers across the U.S. and Canada hypothesized that adding docetaxel to standard therapy could potentially improve overall survival and other clinical outcomes in men with localized, high-risk prostate cancer.

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To Mend a Broken Heart: Sutter Health Starts eCPR Protocol in San Mateo County

Posted on Mar 15, 2019 in Cardiac, Community Benefit, Innovation, Mills-Peninsula Health Services, Scroll Images, Uncategorized

BURLINGAME, Calif. — If you’ve ever watched a televised medical drama, you’ve probably seen a doctor yell “clear” before delivering a jolt of electricity to re-start a patient’s heart. Unfortunately the shows make it seem like the defibrillator works every time. In reality, it doesn’t. Sometimes a faulty heart rhythm won’t return to normal even after multiple shocks, and if the problem is a blocked artery, no amount of shocks will help. In these cases, a patient’s only hope is to receive CPR while they are rushed to a hospital, and once there, receive advanced life support until doctors can repair their heart.

These two life-saving steps form the basis for a new emergency response protocol, called eCPR, which has the potential to decrease deaths from sudden cardiac arrest by 30 percent. Sutter Health affiliated Mills-Peninsula Medical Center is the first hospital on the West Coast to adopt this new protocol, which was proven effective in a 2016 study by Minneapolis-St. Paul area hospitals.

 

‘Hands Free’ Device Performs CPR During Transport

Until recently, it’s been next to impossible to perform effective CPR while in transit. “Our protocol has been to perform CPR at the scene and start transport only if we can stabilize the patient,” said John Kammeyer, Fire Chief, San Mateo Central Fire. Unfortunately many patients never stabilize – and 95 percent of sudden cardiac arrest victims die before they even reach a hospital.

The widespread use of a mechanical CPR device is set to change that. The device, known as LUCAS (Lund University Cardiac Arrest System), continuously delivers the same 2-inch chest compressions that a human hand would during traditional CPR, but the machine makes the process “hands free.” This means that emergency medical technicians (EMTs) can start their drive to the hospital sooner. A LUCAS device is carried on every San Mateo Fire rig that serves the county and two of the LUCAS devices now in the field were donated by Mills-Peninsula Medical Center community benefit.

ECMO Buys Time for Treatment

Once a patient arrives at Mills-Peninsula Medical Center the second life-saving step – advanced life support – comes in. A special machine called ECMO or extracorporeal membrane oxygenation, pumps oxygenated blood through the patient’s body, allowing the heart and lungs to rest while an emergency cardiac procedure is performed.

ECMO can support patients for days to weeks while doctors treat their underlying heart condition and give the heart time to heal. “Historically ECMO has only been used in support of a planned cardiac procedure,” said Joe Walsh, M.D., an interventional cardiologist with Palo Alto Medical Foundation. “Under this new protocol we’re using ECMO on an emergency basis, but time is still of the essence.”  This expanded use of ECMO can only be accomplished if the hospital has trained supportive personnel at the ready – which Mills-Peninsula Medical Center does.

Mills-Peninsula Medical Center launched its ECMO program in 2017 and has treated approximately 25 adults per year with the technology. Dr. Walsh is director of the ECMO Program and has seen first-hand that gallant CPR efforts and rapid use of ECMO can save lives.

Sutter Health a Leading Site Enrolling Patients to the PARTNER 3 Trial for Treatment of Aortic Value Stenosis

Posted on Feb 28, 2019 in Affiliates, Alta Bates Summit Medical Center, California Pacific Medical Center, Cardiac, Eden Medical Center, Innovation, Mills-Peninsula Health Services, Novato Community Hospital, Palo Alto Medical Foundation, Research, Scroll Images, Sutter Davis Hospital, Sutter Gould Medical Foundation, Sutter Medical Center, Sacramento, Sutter Medical Foundation, Transformation

SAN FRANCISCO – Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure done without open-heart surgery to replace a narrowed aortic valve. The procedure is one of several research breakthroughs and interventional cardiology advances being pioneered at Sutter Health through the research of David Daniels, MD, an interventional cardiologist at Mills-Peninsula Medical Center and California Pacific Medical Center who directs Sutter’s Structural Heart Program, and collaborators across Sutter.

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A Focus on STRIVE: Sutter Health Leads its Largest-enrolling Clinical Trial to Date

Posted on Feb 20, 2019 in Alta Bates Summit Medical Center, California Pacific Medical Center, Eden Medical Center, Innovation, Mills-Peninsula Health Services, Novato Community Hospital, Palo Alto Medical Foundation, Research, Scroll Images, Sutter East Bay Medical Foundation, Transformation

SAN FRANCISCO – Several Sutter Health sites participated in STRIVE, a study that is evaluating a new tool for the detection of early-stage breast cancer. Begun in 2017 and now closed to enrollment, the study recruited the highest number of Sutter patients of any trials to date, regardless of therapeutic area.

The multicenter study will evaluate a new blood test potentially complementary to mammography for early detection of breast cancer. The test is being developed by GRAIL, Inc., and the study recruited women at mammography centers across Sutter Health and the Mayo Clinic.

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