Severe consequences of Receiving a Contaminated Human Heart Valve Allograft

The Kenneth J. Alesescu Story

Elective Heart Valve Surgery

On July 17, 2001 forty-nine year old husband and father of our two teenage sons, Ken Alesescu underwent elective heart valve replacement for a congenital malformation of his aortic valve. His doctor presented him with several options to correct the defect and his increasing aortic insufficiency. Being a former chiropractor, Ken knew the type of questions to ask his cardiac surgeon and both discussed the pros and cons of each option. One very important concern for Ken was the sterility, durability and the probability of infection with each valve option. He specifically asked about the sterility techniques in the processing of a human heart valve allograft. His surgeon reassured him that human heart valve allografts are sterilized and stored in liquid nitrogen. The surgeon went on to say, “No organisms could survive such cold temperatures.” So after careful evaluation Ken chose to accept a human heart valve allograft. This choice would change his life forever.

First Signs of Endocarditis

Ken did not recover from his surgery as anticipated. In fact he felt much worse after the valve replacement than he did prior to his surgery. He found himself in the hospital emergency room on August 6, 27, 28-29, then again on September 2 with complaints of extreme weakness, shortness of breath, anemia, low potassium levels, night sweats, an unexplained weight loss and chronic diarrhea lasting for weeks. His cardiologist explained away his symptoms as probably residual effects stemming from his heart valve surgery, so we accepted that explanation and looked forward to the day when Ken would feel better. That day never came. He continued to feel worse and had to extend his medical leave of absence from his employment. Due to a permanent wrist and shoulder injury incurred from an automobile accident a year previously, Ken was forced to retire as a chiropractor and had acquired a job as a sales representative for a long-term care insurance company. Unfortunately, Ken was let go from his position with the firm on December 1 due to his inability to work. He muddled his way through the holidays; however, a new symptom started to emerge. He started to complain of neck pain. Trying to make the best of our children’s Christmas break, Ken decided to take our 15 year old skiing to Lake Tahoe. He was only gone for the weekend of January 5-6, 2002. When he arrived back to our San Luis Obispo home he felt progressively worse and his neck pain had increased substantially. The kids returned to school on Monday, January 7th and Ken slept most of the day. We just thought the quick trip to Lake Tahoe had exhausted him. That evening Ken’s neck really started to throb. Hoping from some relief, he decided to get into the shower and allow the warm water to run down the back of his neck. Unbeknownst to him this would be the last time he would ever walk into a shower.

Devastating Consequences

After a few minutes Ken started to have an unusual numbing sensation travel up his left leg, so he decided to get out of the shower. What became troubling to him was that he could barely lift his leg over the shower stall. He progressively got weaker and weaker. He managed to drag himself to the bathroom counter where he grabbed a hold of the sink to try and support himself. He now felt the numbing sensation begin to travel up the left side of his body into his arm…Frightened, Ken held tight to the sink and started to yell for help as his left leg began to slowly buckle out from underneath him. Fighting to stay upright, one by one each finger lost its grip sending Ken slithering to the cold bathroom floor. Ken was rushed to the hospital at approximately 10pm. By the time paramedics got him to the emergency room the whole left side of his face was paralyzed and he was having difficulty speaking. Approximately 11pm on January 7, 2002 we got the devastating news that Ken had suffered an acute hemorrhagic cerebrovascular accident, which left him paralyzed on the entire left side of his body. Smoldering for months, the nightmare of that fateful decision he made on July 17, 2001 was just starting to reveal itself; however, it still would take physicians approximately another 4 weeks before they could determine the cause of the stroke as a fungal vegetation breaking off his aortic valve replacement due to fungal contamination by a rare form of Candida spp., Candida tropicalis.

As the days rolled on the magnitude of the fungal infection started to become painstakingly clear. There was fungus in Ken’s blood stream, in his urine, and in his cerebral spinal fluid bathing his brain and spine. Ken remained in critical condition and by week’s end; neurologically Ken had become less and less responsive to the point of lapsing into a pre-coma state. At that point, on January 12, 2002 a neurosurgeon was called in to conduct life-saving brain surgery to relieve the extreme pressure on the brain from a blood clot the size of plum, which had formed due to the continuation of bleeding into Ken’s brain. The surgery was successful and miraculously, Ken made it through yet another critical health crisis. However, a new crisis was just around the corner.

Fungus destroys vertebra - Fungus on the heart valve

As Ken became more aware of his body, the pain in his neck he had been experiencing for a couple of weeks now became intolerable. Doctors, nurses, physical therapists would try to move him and he would let out blood curdling screams of agony day after day. Finally, an MRI was conducted and yet another devastating blow was revealed. The fungus had entered Ken’s neck and virtually had eaten away two vertebra which left his spinal cord exposed and pinched. Any wrong movement could have transformed Ken from a hemiplegic to a quadriplegic. Due to the precarious state of his neck once again Ken had to endure yet another surgery. This time it was reconstructive neck surgery. Doctors started to suspect that if the fungus was in the bloodstream, in the spinal fluid, and in bone then there is a good probability that the fungus was also in his heart. An echocardiogram was conducted and sure enough doctors finally found the culprit of the fungal infection: the heart valve allograft. The valve was covered in fungal growth with large vegetations hanging precariously from it. One false move could send yet another mycotic aneurysm to the brain. After weeks of IV Amphotericin B (a powerful anti-fungal medication) it was determined the treatment was not successful in eradicating the fungus from the allograft; subsequently, the valve needed to be replaced. The surgery would be quite extensive and high risk; unfortunately there were no doctors in our area willing to undertake such a difficult surgery, so Ken was transferred to Northern California and away from his family.

Transferred 300 miles away from family for second heart valve surgery

On February 25, 2002, Ken was transferred to a Northern California hospital for his second dangerous heart valve replacement surgery. Our sons and myself clung to each other as we wept and watched helplessly as they loaded Ken into an ambulance for the six-hour journey to Northern California. It would be seven grueling months before he could return to his home in San Luis Obispo. He was faced yet again with his third high risk surgery since January 12, 2002. In the ambulance the mood was solemn and quiet. Ken could hear soft music playing in the background as he stared at the ambulance ceiling. Occasionally he would glance at the IV and watched the solution drip silently down into a plastic tube which was inserted into his chest. The six-hour drive allowed Ken a substantial amount of time for reflection and contemplation, which turned to uncontrollable fear and weeping over where he had been and what he was about to face. On March 4, 2002 Ken underwent his second heart valve replacement using yet again another human heart valve allograft from the same company that was used initially. I was quite concerned about this decision. A month previously I had started to research the use of human heart valve allografts and I came across three other cases of alleged contamination by this same tissue processor, one in 1995, 1996, and again in 1998. I discussed my concerns with his cardiac surgeon, and he tried to assure me these were isolated cases and Ken would be receiving the “Cadillac of heart valves.” Reluctantly, on the advice of the surgeon we accepted his recommendation and moved ahead with the surgery. Unbeknownst to us once the surgeon opened up Ken’s chest and took one look at the condition of the valve, the amount of fungal growth isolated only on the valve and the lack of involvement of the prosthetic ring placed on the mitral valve the surgeon drew the conclusion that indeed the aortic valve allograft was the culprit of the disseminated fungal attack on Ken’s riddle body. The treating physicians had not disclosed their findings to us. However, within eleven days the story would be revealed.

Puzzle pieces starting to fit.

In the months leading up to Ken’s surgery I had been doing a little investigating myself and had voiced my concerns to a good friend. Approximately in mid-March this same friend called to inform me her husband had just read a news article about a young-man who died after receiving a contaminated knee allograft from the same company I had concerns about. This confirmed in my mind my suspicions surrounding this company were valid so I immediately contacted the FDA and CDC to report Ken’s infection and voice my concerns. Much to my surprise, I spoke with the lead investigator, Dr. Marion Kainer from CDC and she informed me that an unidentified nurse had contacted her regarding Ken’s infection and an investigation had already been initiated. Over the next several months I had learned about the serious problems, which plagued the tissue industry and the lack of safe guards in place to ensure the highest quality standards were being utilized and enforced in the processing of human tissue. To date, the Food and Drug Administration, (FDA) has very few regulations in place to ensure that tissue processors engage in the safe handling, processing, and distribution of human tissue for transplantation. Ken and I had become painfully aware of the consequences surrounding the lack of regulations imposed by the FDA. Searching for answers, I was able to track down the procurement agency through a certificate provided by the tissue processor which was included in Ken’s medical records. What I had learned is the tissue was sent to two processors; one who tested the tissue upon arrival to their facility and the other did not. Subsequently, it was discovered that upon pre-testing, one processor discovered the pericardium of the heart and an Achilles tendon had fungal contamination and discarded the tissue while the other tissue processor chose not to pre-test and instead processed the tissue and distributed to the Northern California hospital where it was implanted into Ken. Pre-testing of tissue is the industry standard; however, it is only recommended by FDA and is not required. Had pre-testing been a requirement perhaps it could have saved the lives and limbs of many people.

Discharged! but only short lived

July 3, 2002- Independence Day- Ken’s. At last, after seven months of being in the hospital Ken was finally able to come home. However, his stay would only be brief due to another smoldering pocket of this relentless bone eating fungus. Ken was home for only a week when he started to experience seizures. Once again he was transferred back to the hospital and under went multiple testing to determine what was triggering his seizures. It was revealed that Ken had sustained permanent brain damage from his initial stroke which now was triggering seizures. This would be a life long problem for him. He was prescribed anti-seizure medication which would only decrease the frequency of the seizures and not get rid of them entirely. Once doctors found a suitable dosage of anti-seizure medications for Ken, he slowly started to tackle the difficult task of living with a disability through physical therapy. As a couple of weeks passed, a new pain emerged. This time in the low back. Ken tried to live with the pain; however, it got progressively worse and began to interfere with his physical therapy. The pain became unbearable and once again we found ourselves in a hospital emergency room. An MRI of his low back was performed and it was discovered the very same fungus had now emerged in his low back eating away his spine. The drill became all too familiar to us. Yet another spine reconstructive surgery, the fifth in a year and another hospital stay this time lasting for two months. Late August Ken once again had to endure another regime of anti-fungal therapy using the potent anti-fungal: Amphotericin B to try and rid his body of the fungus once and for all. This time around the medication started to have toxic affects on Ken’s kidneys. Each time they would hook him up to the medication Ken’s body would shiver and shake as if the medication was freezing him from the inside. Nurses would have to wrap him in warm blankets to try and reduce the shaking which Ken endured. This went on for 6 weeks. Finally in late October Ken was released from the hospital, but again his freedom would be fleeting.

Second round of endocarditis - second heart valve is failing

Ken started to get weaker and weaker. His doctor became concerned and starting running more tests. It was determined that Ken once again became very anemic. We started to get quite nervous for fear the relentless foe had returned. His doctor order him to go to the local hospital as an outpatient to receive blood transfusions. Thinking Ken would only need a couple of units we expected to remain in the hospital for a very short period of time. However, after each unit was transfused they would check his red blood cell count and it remained low. They continued into the night giving blood trying to get his count up to an acceptable level. The signs of a second bout of endocarditis became painstakingly clear.

Ken never left the hospital and remained for another month getting progressively weaker and entering into congestive heart failure. Once again an echocardiogram was ordered and once again it was revealed that Ken had another heart valve infection. This time it was a ferocious bacteria. The horrible nightmare he underwent the beginning of the year started all over again at the end of the year- this time it would be much more difficult. He was faced again with another failing heart valve allograft which was being destroyed by a brutal bacteria. We were told in order for Ken to survive he would have to endure yet another heart valve replacement surgery. His cardiologist also informed us it was highly unlikely we would find another surgeon to take on his difficult case. With regret, the cardiologist informed us there is nothing more he could do, but agreed Ken's best bet was to once again endure a third regime of long-term IV antibiotic therapy and hope for the best. We requested for Ken to be allowed to come home for the holidays which what we thought would be our last. With the help of a home health nurse I learned how to administer his IV antibiotics and give him injections of medication which would try to initiate red blood cell production. Ken grew weaker and weaker. He lost over 100 pounds, he could not keep his food down and lost control of bowel and bladder function.

Losing his mind - Prognosis is grave

By the end of January 2003 Ken started to lose his memory and could no longer recognize his children. At this point I received the devastating news from Ken’s cardiologist without the removal of his infected heart valve allograft Ken would only survive another 3-6 months, so he referred us to Hospice. Even if I could find a doctor willing to operate the mortality rate of a man in Ken’s condition would be 70-90% and it would be quite doubtful that any surgeon would be willing to operate under such conditions. I watched my husband slowly slip away and became a mere shadow of his former self.

In January 2003 Ken once again found himself in the hospital in heart failure and the doctors would once again start the unloading process of fluid build-up around his failing heart. During this hospital trip Ken also was diagnosed with hydrocephalous (fluid build up around the brain due to the infectious process) He was beginning to surrender to his failing state. In order to stop the progressive fluid build up around his brain Ken would have to undergo another brain surgery for cerebral shunt placement allowing fluid to drain into his stomach. However, due to Ken’s failing health no doctor would accept this challenge. Once again Ken was sent back home. I would sit at his bedside watching him struggle to breath. I was told this pattern of breathing was called Cheyne-Stokes respiration. It is a type of breathing pattern a person settles in to when they are experiencing severe heart failure. I could not sit back and do nothing. I decided to drag him back to Northern California to an infectious disease doctor and begged him for help. Fortunately for Ken, this doctor saw a very faint glimmer of hope. It was determined that Ken should have immediate brain surgery to relieve the fluid build-up and pressure around his brain. This would be the first step in making him a more suitable candidate for heart surgery. This doctor called on the treating physicians in San Luis Obispo and was able to convince them to proceed and accept the challenge of a cerebral shunt placement surgery. If Ken could survive this surgery he could possibly become a slightly better candidate for cardiac surgery. The push was on to find a cardiac surgeon.

Searching for a third cardiac surgeon - No takers!

I spoke to numerous cardiac surgeons from Southern California to Northern California and still could not find a surgeon willing to tackle this risky procedure. Ken’s case was even featured before a conference at the world-renowned Stanford University Heart Center. Again I was informed no surgeon would accept his case. I turned back to the Northern Californian infectious disease physician who was instrumental in getting doctors in San Luis to place cerebral shunts in Ken’s brain pleading for help yet again. It is now March and time is ticking away. He approached a couple of doctors- still no takers. Ken was in and out of the hospital almost every month fighting for his life. Then in late March Ken became very ill. He was running a 107-degree fever and was rushed to the hospital and placed in ICU in critical condition. He went into septic shock and was not expected to make it through the night. At about 4am he went into respiratory distressed and enters into a coma. I remained at his bedside and held him rocking him gently while I quietly wept and whispered to him how much I love him while the nurses prepared to place him on a ventilator. The nurse placed a tongue guard in his mouth and began to insert the tube down his throat when Ken opened his eyes startling everyone. Another miraculous recovery started to emerge stunning his doctor and the ICU nurses. Around this hospital everyone knows about Ken Alesescu, the man with nine lives. Still we were faced with the issues of Ken’s failing heart. It is late March and no doctor in site to conduct his life saving valve replacement surgery. With each passing month my awareness of June, the six-month mark became painfully acute.

Finally a surgeon comes forward - Third and final heart valve surgery

Finally, in May with one month to spare a cardiac surgeon emerged and accepted to conduct this extremely difficult surgery. We spoke to this surgeon and expressed our wishes not to receive another human heart valve from this company. Thankfully, he respected our wishes and used a porcine valve. Still this doctor was faced with the insurmountable task of operating on a man who had been written off as good as dead by all doctors before him. We were elated that he agreed to do the surgery but we were soberly aware of the high mortality rate of such a procedure. We chose to move forward and on May 16, 2003 Ken underwent his third and final heart valve replacement surgery. I sat in the OR waiting room on pins and needles second-guessing our decisions. One doctor actually told me if I pushed to have someone operate on Ken I would have sentenced him to a painful death with his last days in a hospital room on a ventilator. I kept glancing up to the clock watching the time creep slowly by hoping and praying the prediction of this previous doctor would not be realized. I could no longer sit idly by in the waiting room listening to my questioning voice. I began to pace up and down the halls, I sat on a gurney outside the swinging OR doors, I would walked back to the waiting room only to turn around and start my trek all over again. Finally I saw the surgeon emerge from the swinging doors of the OR. My heart was in my throat as I watched him walk towards me. From a distance I tried to read his body language and facial expressions-searching for any clue that the surgery was a success. It was probably the longest minute of my life. As he got closer he removed his mask which revealed a confident smile. At that moment not a word was spoken and I burst into tears realizing his satisfaction and proceeded to hug him. He informed me he really had to beat Ken up but felt the surgery was successful. I looked to the sky and thanked God because without him and the willingness of this surgeon Ken would not have survived.

One day at a time

As I write this it is now April 2004 one month shy from the one-year anniversary of Ken’s last heart valve surgery he remains home and infection free with his family. This will be the longest stretch of time to be home since his July 17, 2001 initial heart valve surgery, which started this whole nightmare. He has not escaped his battle unscathed. He remains on lifetime antifungal therapy to suppress any reoccurring fungal infection- so far it appears to be working. Due to the attack of both fungal and bacterial endocarditis and multiple heart valve replacements Ken remains in heart failure, however it is currently being managed with medication. He still is very weak and remains bedridden with brief periods of sitting up in a wheel chair. We look at everyday as a gift and treasure our time together. We both realize his time here has been drastically cut short but for the moment we have been given a reprieve and the luxury of a long good-bye which we will savory each and every day.

Ken and Pam Alesescu