Men and women who have undergone heart valve replacement with artificial heart valves have a new "accompaniment" which wasn't there before the operation and which may even be audible at complete physical rest: the clicking of the valve. Usually the valve has a soft, high-pitched click. Increasing blood pressure causes the heart to beat more forcefully and thus makes the sound become louder. This is quite normal with the materials used and there is no need for you or your partner to worry.

When the "clicking" signals a sense of achievement

What is new, however, is that the "state" of the person with the artificial valve - whether agitation or annoyance, joy or arousal- can be recognized more quickly by the other/another person if he or she listens carefully. This may, of course, be a disadvantage if a person does not wish to reveal his or her feelings. On the other hand it can also be a source of pleasure, e.g. if the reaction to a loving experience is also audible or if the clicking signals confirmation or a sense of achievement. As always, this depends on the situation and the relationship between the partners.

A faster pulse under stress is normal

If you are able to cope with normal everyday stresses there is no reason for you or your partner to get worried if you breathe more deeply or have a faster, stronger pulse when sexually aroused or during sexual activity. As we all know - this is all part of our normal response. However, after a previous poor state of health - when the same reactions could be a sign of deterioration or particular stress - it is quite understandable if you or your partner find it difficult to regard these reactions as normal after the operation.

There is only one thing to remember for the early phase after the operation: that is that the opened breastbone needs a few weeks for complete bony repair and that therefore not every position will be possible at the very beginning. On the other hand, if both partners want to continue an active sexual life but some sexual practices are too stressful (e.g. if the heart has not regained its full strength), it should not be difficult to come to an understanding that the "weaker" partner can assume the more passive role and may need a different position so that both can experience and enjoy sexual pleasure without risk.

The only thing that is "forbidden" is, of course, something that one partner does not like it or that puts him or her at risk.

Dr. med. Artur Bernardo, Medical Superintendent, Clinic Gais, Gais (Switzerland) (2003)

Notice to patients:
Please speak to your Doctor before taking any medication other than that which has been prescribed by them. Please always tell the pharmacist that you are on oral anticoagulation therapy when purchasing any medication over the counter. This applies to creams and gels als well as tablets.

Speak to your Doctor before applying any therapy subsequent to the aforementioned information.

It's holiday time at last! Time to plan where to spend your holidays this year. And in the family its just like in politics. One person wants to go to one place, the other wants to go somewhere else. A consensus has to be reached. But then there's the new heart valve! What about the long mountain hikes in the Alps now, the lazy beach holiday under palm trees, the long cycling tours in Mecklenburg, the cruise with a luxury liner or the family holiday by the sea? The same question comes up again and again: what can I ask of myself and my new heart valve? And as so often, the opinions on this vary. In principle you can assume that it is all the same to your heart valve where you spend your holidays. Once the valve is properly implanted and the heart muscle is strong - whether this is the case will emerge very soon after the operation – it can travel by plane, cycle, swim and play tennis.What is more important is how you feel. Has your doctor found that you have high blood pressure, or is your heartbeat still irregular? In other words: ask your cardiologist or family doctor for advice on how much you can do. If your doctor gives you the go-ahead, there is practically nothing to stop you going on the holiday of your choice - apart from the question of your anticoagulant therapy while you are away.Of course, you can just carry on taking the same dosage of anticoagulants as usual for these "best three weeks of the year". And then, shortly after you come back, have your INR/prothrombin value checked by the doctor. By this time four weeks are sure to have gone by. But you don't know what your INR/prothrombin value was doing during this time. Even if you adhere to your prescribed daily dose of anticoagulants, climatic changes, different food and even diarrhoea can influence coagulation. We do not know why these factors influence coagulation but they do.In order to prevent possible complications such as bleeding or thromboembolism it is advisable to use coagulation self-monitoring. People who already use coagulation self-monitoring appreciate being able to check their clotting values at more frequent intervals on holiday than when they are at home. The CoaguCheck system available for this is very handy and takes up little space in your luggage. If you are travelling by air you should be sure to take the meter onto the plane with you as hand luggage. Nothing could be more unpleasant than if your luggage - for whatever reason - did not arrive at your destination until a few days later. You should always carry your medication in your hand luggage too.A few tips: buy a pill container for your hand bag or pocket which holds at least enough medication for a few days. Wrap sufficient test strips in aluminium foil and - if you are travelling to a warm country- put them in the Minibar when you get to the hotel.

On this note, have a good holiday!

Christian Schaefer (2003)

Notice to patients:
Please speak to your doctor before taking any medication other than that which has been prescribed by him. Please always tell the pharmacist that you are on oral anticoagulation therapy when purchasing any medication over the counter. This also applies to creams and gels as well as to tablets.

Speak to your doctor before applying any therapy subsequent to the aforementioned information.

There is only rare, and no current, scientific data on travel habits or travel-associated incidence of bleeding or thrombo-embolic episodes”, pointed out Heinz Völler, MD, of Rüdersdorf, Germany, in his talk. "The major consequence for the patient should be intensified INR testing while traveling to identify relevant changes at an early stage, enabling the taking of adequate counteractive measures." Changes in INR can be caused by drug-drug interactions, e.g. for tetracycline the bleeding risk is ninefold. "But patients should definitely not be discouraged from taking an adequate antibiotic and malaria prophylaxis or having the required vaccinations," said Völler. Formerly, vaccinations in patients on treatment with VKAs were all given subcutaneously until it was recognized that adjuvants induced an unacceptable rate of local reactions and that the intramuscular route was possibly associated with a better immune response.Infectious diseases lead to a procoagulant or hypocoagulant status, and are associated with an increase in the activity of some clotting factors, especially fibrinogen and factor VIII. This means an increase of thrombophilic risk, although the INR may remain unaltered. Völler strongly suggests an optimal protection against infectious diseases such as hepatitis.In addition, changes in lifestyle can change the INR, including several exotic foods and increased consumption of alcohol. Climatic influences also play a role: High temperature increases the bleeding tendency due to vasodilatation. High altitude (>2500m) means a 2.7-fold increased risk for lower INR values. "If traveling by air, the self-testing device, all equipment and all drugs should be carried in the hand luggage" Völler advised those patients present. "X-ray at the airport does not harm the functioning of the device, and it’s important not to forget: a reliably working refrigerator is required at the destination."

Report by Thomas Klein, MD, MSc (Nov. 2009)

In his second talk of the day, Scott Kaatz elaborated on the multiple modalities available to manage patients who are anticoagulated with Vitamin K antagonists, such as patient education, patient self-testing and patient self-management. Kaatz examined how these different systems affect the patient’s quality of life. 
"There has been much scientific emphasis on clinical outcomes of thrombo-embolic and hemorrhagic complications. In contrast the direct impact on patients’ quality of life has been less well investigated," said Kaatz.

Kaatz had no doubt that the most accurate way to measure the effect of different management modalities on patients' quality of life is through randomized clinical trials. However, clear answers are prevented by the low availability of studies, especially for the comparison between usual care and anticoagulation management service, as well as multiple evaluation tools and global quality-of-life questionnaires, which may not be precise enough. However, given these limitations, one questionnaire, specifically designed to evaluate the effects of patient self-testing or management on quality of life has been used in several trials and has shown consistent improvement in patients’ well being.

"As compared to usual anticoagulation monitoring, patients enrolled in anticoagulation management service have a perception of improvement in their care. Patients empowered to perform patient self testing or management have further gains in their quality of life," concluded Kaatz.

Report by Thomas Klein, MD, MSc (Nov. 2009)

Telephone interviews were conducted last year in England by ACE (AnticoagulationEurope) and AFA (Atrial Fibrillation Association) with 104 patients with atrial fibrillation. The results, even with this small sample, represent the problems associated with the treatment of patients with atrial fibrillation. For 72% of patients the treatment with Vitamin-K-Antagonists started immediately; for 20% however, it started only after a longer period of time (up to one year). 75% of the interviewed patients were verbally informed about the treatment, whereas only 36% were able to explain that anticoagulation can prevent strokes. Only 25% sought further information. "Doctors should take stronger influence on the insufficient INR-controls and make patients to equal partners in the handling of their treatment with anticoagulants," says Eve Knight (ACE).

Patients need information they can understand. Information provided verbally – often very quickly – are not always fully understood. Especially given the complexity of anticoagulation more than verbal information is needed. Many globally available medical publications address the question how the patient can be involved to cooperate. Proposals are plentiful. Prof. Dr. med G. Lip et al: "Patients need clear and simple information, tailor made to their personality (Thromb. Haemost 2011, 106:997-1011)."

However, anticipating that – as shown in the survey – only 25% of patients seek further information, meaning they are interested and want to cooperate, it is not surprising that the essential treatment with anticoagulants is a “red rag” for both doctors and patients. Anticoagulation-self-management could be the key to effective patient cooperation. M. Schwebe et al, University of Greifswald write: "Incomprehension exists even within experts that only 20% of all patients in Germany on anticoagulation therapy practice Patient-Self-Management (PSM)" (PharmacoEconomics – German Research Articles 2012: 10 (1)).

Doesn't motivation for the weekly INR-Test start with the questions: Am I within the therapeutic range? If not, what did I do incorrect and what can I change and potentially improve with my lifestyle?

Dr. med. Hugo ten Cate nails it: "Quality of life and time within therapeutic range can be influenced positively through Self-Management" (Thrombosis and Haemostasis 107.5/2012).

Christian Schaefer (July 2012)

A plus in quality of life happened for Heike Sichmann, the pioneer in INR self-management, in 1986. It was and is the independence of continuous INR tests at the doctor’s office. This "Plus" was successfully implemented by Dr. med Carola Halhuber and Dr. med. Angelika Bernardo by taking up the concept of coagulation self-management. The first patient trainings were conducted in Bad Berleburg, patient seminars – exemplary at that time – explained the handling of anticoagulants, patient advisors and scientific studies followed. The first globally shared results from Dr. med. Angelika Bernardo showed that 83.1% of INR values (called Quick.value back then) performed by patients themselves during 1986 and 1992 were within the therapeutic range. The recommendations which came from Bad Berleburg at that time are still valid today. Looking at international scientific literature with regard to this topic - based on countless studies – indicates that it was not believed, what was initiated in Bad Berleburg, Germany. The sentence: "Additional big studies must confirm these results" appears constantly at the end of almost every study. In Germany, however, INR self-management developed further; even though there were and still are some questions on the conclusiveness of the evidence. "The mature and responsive anticoagulated patient does not exist." After all – according to the opinion of well-known scientists – half of the anticoagulated patients would be able to perform self-management (Thomas Decker Christensen, Dan Med Bull 2011; T58(5): B4284). Taking numbers from Germany as the base, 20% of patients are testing their INR by themselves, but on a global basis only 0.05% do. Studies on INR self-management since the last 20 years cover the patient’s quality of life only limited. More important was first to determine how often INR values fall within the therapeutic range; is there an increased bleeding rate? Are there more thromboembolic events? Are the coagulation meters safe? Are patients able to dose themselves? Everything is always in comparison with professional testing. Nevertheless there are few studies which confirmed an improved quality of life. And this "Plus" in quality of life is what we experience ourselves daily.

Christian Schaefer (Oct. 2011) 

"For every long-term treatment patient compliance is of the essence. It has been proven that compliance is improved, if patients are educated about the risk and benefits of the respective treatment", so Prof. Dr. W. Wuillemin (Schweiz. Med. Forum No. 17 v. 25thApril, 2001).

How is the situation regarding patient education? Is the current practice sufficient to achieve compliance in life-long treatment?

Prof. Wuillemin continues: "Unfortunately, patient education is often insufficient in patients on oral anticoagulation treatment." Insufficient patient education often results in an  irregular intake of the medication, potentially leading to a thrombo-embolic event. Compliance is not only relevant for patients on oral anticoagulation, but also for other indications. According the study "Compliance of patients with hypertension" done by Dr. Christian Schäfer, Johannes Gutenberg-Universität Mainz, Germany, two out of three patients insufficiently follow their HCP’s instructions and therefore jeopardize therapy success (press release German Heart Foundation, May 2010). Similar results could be shown by B. Vrijens, Belgium (BMJ 2008; 336:1114-1117) in his study on 4’783 patients with hypertension. Although these patients participated in clinical trials and electronic drug dispensers were available, it could be shown that not following instructions by HCPs was a main issue for insufficient compliance. The trial looked at anti-hypertension drugs which had to be taken once daily. After one year, almost half of the patients discontinued treatment, although it was planned as long-term treatment. Within one year, 48% of patients temporarily stopped treatment for several days (“drug holidays”) and 13% temporarily discontinued treatment six times for several days. Close to 95% forgot to take at least one dose within one year.

Most cases of non-compliance occur on weekends. Patients normally taking their dose in the morning, tend to miss drug intake on Sunday morning, those taking their drug in the evening, tend to miss drug intake on Saturday evening.

Lack of compliance is a major issue for clinicians. Writing a prescription is easy, education on therapy goals and importance of compliance is still a challenge.

Christian Schaefer (May 2011)

Millions of patients globally are treated with oral anticoagulants. Challenges associated with this treatment are dose finding and the INR monitoring, so Prof. Sogkwan Silaruks, Thailand on the "Asia Pacific Cardiology Forum" on June 15, 2010 in Beijing. The situation of anti-coagulated patients in Thailand can hardly be compared to the situation of patients in developed countries. Compliance of patients is influenced by many factors. Level of education is important, but also the ability of patients to care for themselves, low income, transport issues in rural areas, and the  cost of treatment. Therefore, a team was formed in Thailand, consisting of physicians, pharmacists and specially trained nurses. Goal of this "Anticoagulation Forum" is to improve management of anti-coagulated patients. Oral anticoagulants safe lives, but there are also some risks associated with them. To minimize these risks, the time patients spend in therapeutic range needs to be increased.

South Korea is more advanced in this respect. Travelling to hospitals for INR monitoring is inconvenient for patients, due to travel and waiting time, so Prof. Yong Seo Oh, Seoul. Patient self management can significantly simplify this process. To find the best suitable testing model depends on the individual patient. "Frequent monitoring is more important than the question where testing takes place. Here, patient self management offers a very good alternative."

In addition, anti-coagulated patients start being active themselves in Seoul: they have established a patient association.

Christian Schaefer, Oct. 2010