HOME AGAIN
We were delighted on our return from holiday to see the letter below from the lovely team in Israel who developed the machine to enable denervation to be carried out. On reading it there seems to be a positive for this procedure to be continued so hopefully in the future we will see more having this op done. The op itself has proven to be safe ( something I know as I came through it unscathed) so praying for all to continue down this path
It is very rare indeed to receive a letter such as this and I have done endless studies and trials so it was very touching. I count myself fortunate to have been given the opportunity for this so no thanks were needed but nice anyway to let us know where we were up to with it.
Firstly, Sonivie, the Sponsor of this study would like to sincerely thank you for your participation in the very first clinical trial evaluating the Therapeutic Intra-vascular Ultrasound (TIVUS") System for pulmonary artery denervation in patients with pulmonary hypertension. It is because of the involvement of participants like you that we are able to take the first steps to evaluate this new potential treatment for pulmonary hypertension. Without you, this would not be possible.
We would like to share the main results that you and the other participants have allowed the Sponsor to generate. In total,14 participants were enrolled in the CLNS01-001 study for an initial one-year hospital visit follow-up which was then followed by a long-term surveillance at 36 months after the pulmonary artery denervation procedure date.
Pulmonary Arterial Hypertension occurs when the blood pressure in your pulmonary arteries (thevessels that bring blood to your lungs) is increased due to narrowing of the small arteries of the lungs. In this study, the TIVUS" System was used to carry out a new procedure called pulmonary artery denervation. By deactivating some of the nerves around the pulmonary arteries, pulmonary artery denervation was hoped to lead to reduced blood pressure in the lungs, improved heart function, exercise capacity, activity levels and wellbeing. The pulmonary artery denervation procedure used ultrasonic (high frequency sound) energy during a right heart catheterization procedure.
The main aim of this study was to collect information about the safety of the denervation treatment of the TIVUS System in adult patients with pulmonary hypertension. We are happy to let you know that the results of the Trophy-1 Study demonstrated initial safety of the TIVUS" System when used for the treatment of pulmonary arterial hypertensive patients. The treatment was well tolerated by most of the patients, with pain well managed when present during the treatment and during the study no device-related or procedure-related serious adverse events were reported which demonstrated the safety of the procedure.
The pre-specified effectiveness endpoints noted in the Patient Information Sheet were for haemodynamic evaluation, quality of life score and the 6 Minute Walk Distance. At the 4-month follow-up a statistically significant reduction was identified in the haemodynamic measurements for the mean pulmonary artery pressure, pulmonary vascular resistance and the right atrial pressure. Improvement was also identified in the patient cardiac output, activity levels using the wrist actigraphy data collection device, the 6-minute walking distance completed and the quality of life questionnaire score. In addition, the procedure was well tolerated by the patients, the catheter was easy to use, and the pulmonary artery denervation procedure was around 30 minutes in duration
long-term follow-up of the participants indicated a potential benefit of the TIVUS" System treatment up to 18 months following treatment. These very first results are promising and support future clinical studies to the confirm the good safety profile previously seen and to see if a repeat treatment from18-24 months could be beneficial to patients.
Thank you again for your valuable help with the first steps of the development of the TIVUS" System for pulmonary artery denervation in patients with pulmonary hypertension.
SIX WEEKS ENDED TOO QUICKLY
Our holiday in Spain went exceedingly well and I was fortunate enough to enjoy reasonable health throughout. It was such a delight to see all of our friends made since we lived in Spain and indeed some we made since leaving Spain. We had good weather except for one day so cannot complain. Each day we walked to the Port for coffee and later walked along the Arenal so I could get my steps in. I did wish I had had the opportunity to have my ferrinject infusion before I went but we coped. However had I had this I know I would have had more stamina.
I received lots of e mails giving me dates to see various specialists when we were on the ferry travelling over to Spain. Although we had been told we would see a specialist urgently we were assured that it would be at least two months so decided to just go for it and have our holiday. We were shocked when we could have them so early and had to ring each and every one and explain that this holiday was important and we could not make them. New appointments were made and we knew there was such much ahead for us once back in the UK so we tried to put it all to the back of our minds and enjoy each and every day of our precious time in Spain.
Long leisurely lunches were the order of the day with me then going back to our apartment to rest. Tiredness would just become overwhelming and no matter where we were I would have no option but to go home. Lack of ferritin is awful and the tiredness we get is so unlike a normal type. We with pah suffer so much from it as for lots of us our bodies do not absorb iron and these infusions are a very necessary part of our treatment. Our friends are all so lovely and would be so understanding so when I had so rest I had no worries around them at all. They totally understood.
Colin is planning on returning in September to lead a few walks but I do not wish to fly so will be happy to stay here safely at home.
AN ABSOLUTE TSUNAMI OF COMPEX ISSUES
Not for me a nice gentle pattering of rain that gives you time to get a raincoat on before the heavens open. No my tsunami of issues rained down on me so hard and fast I barely had time to take a breath, pelting me with one thing and then another. Since our return home we have had endless rounds of hospital visits, x rays, blood tests, echos etc we have barely drawn breath. It seems that on top of needing oxygen at night and my carpel tunnel in both hands I now have been diagnosed with systemic scleroderma. My specialists says this a rare form that attacks my internal organs. Oh whoopy do indeed. On top of that I am told there is something else showing in my blood that needs to be diagnosed yet. They have not got to the bottom of it. What joy lays ahead. I am shortly to get my muscle conduction tests too to see why my muscles are wasting away. It appears my weight loss is due to my muscles disappearing. No wonder I cannot lift my leg onto a buffet to tie shoe laces or indeed even get up if laying on the floor after doing my denervation test. It takes me so long as I do not even have much use of my arms as my carpel tunnel prevents me from putting too much weight on them. On the plus side my infusion is working and I have much more energy now three weeks after it took place.
Next step for me is to see my ph specialist at the end of this month and to have an MRI plus the barrage of other tests, walking, breathing etc that most of us know so well is part and parcel of having ph. Before then I am to have my injections for shingles, pneumonia top up and my fourth covid one. These need to be in place before the new tablets I have begun to suppress my immune system take full effect. I have only been on them a week and I was told it takes four months to work efficiently. Apparently the "norm" if there is such a thing would be to develop the systemic sclerosis first and later develop ph but I did it the other way round 12 yers after diagnosis. She says it is all very puzzling. When I asked the question would this kill me she was very diplomatic and said "we will talk about that later" Quite why I asked the question when I am already suffering a life shortening illness I don't know. On my second visit I forgot to ask her so still the question sits silently in the background.
None of these will spoil my zest for living. I will not let it leave me in a heap on the floor. We have to make the most of our lives and make the most of every precious moment and I intend to do just that. Covid has helped somewhat with this as we have all got used to wearing masks, something I will need to continue as my immune system gets less and less. Our friends already are good at letting us know if they are feeling unwell so we stay away from them but apart from that we must live our lives. So much to see and do yet.
JUNE CELEBRATIONS
We decided this year due to so many hospital visits etc to not do much about veg. We have planted potatoes in the raised bed and onions in the other and also dotted onions all around the garden in the hope they keep the aphids at bay. Maybe next year we will grow more but this will suffice, We still have two apples trees, a pear tree and blueberry bushes so it just must do us for now. I have bought tomato plats though as I love tomatoes.
I am still walking daily. Today I got Izzy to school for 7.45 and parked up and walked into town to collect something I needed. I then walked back to the car and by then I had done 12200 steps so was pleased with that. I may go out for a small walk this afternoon. We shall see as my son is supposed to be coming but if he leaves early I will go for Izzy early and walk around the park. I still remain very positive.
Izzy continues to be a delight but to my dismay she is growing up so fast she is almost galloping. I bemoan the fact I have lost my baby but she just says "well grandma that is just how it is, we must grow up" and of course she is right but it pains me anyway. Somewhere in the back of my mind is the saying that I blinked and there before me stood a man, the same has happened with her. We just turned around and our curly haired little dot that absolutely adored us is now very capable and does to need us quite the same. Such is life.
Though it has been a long time in coming this blog I cannot think of anything else to tell you so I will love you and leave you and of course thank you for reading this. Take the best care.
Warm love
Carole xxx
