NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

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1 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Implanting pressure monitors in the pulmonary artery to monitor chronic heart failure Heart failure means the heart does not pump enough blood to meet all the needs of the body, usually because the heart muscle has been damaged. It is often associated with changes in the blood pressure in the pulmonary artery, which takes blood from the heart to the lungs. In this procedure a small pressure monitor is implanted in the pulmonary artery. The monitor transmits information about the pulmonary artery pressure to a computer. Based on this information, the person s condition can be checked and their treatment changed if necessary. Introduction The National Institute for Health and Care Excellence (NICE) has prepared this overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared This overview was prepared in December 2012 and updated in July Procedure name Insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Specialty societies British Cardiovascular Society British Society for Heart Failure. IP overview: insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Page 1 of 21

2 Description Indications and current treatment Heart failure is a complex clinical syndrome of symptoms and signs that occurs when the efficiency of the heart as a pump is impaired. It is caused by structural or functional abnormalities of the heart. Pressures rise within the heart and this leads to a rise in pulmonary artery pressure, which can cause pulmonary oedema and breathlessness. Fluid retention by the kidneys also contributes to high cardiac and pulmonary pressures and can produce peripheral oedema. The most common cause of heart failure in the UK is coronary artery disease. Around 900,000 people in the UK have heart failure. It has a poor prognosis: 30 40% of patients diagnosed with heart failure die within a year but thereafter the mortality is less than 10% per year. There is evidence of a trend in improved prognosis in the past 10 years. The 6-month mortality rate decreased from 26% in 1995 to 14% in Heart failure is often assessed using the New York Heart Association (NYHA) functional classification system; classes I and II describe mild heart failure with no or slight limitation of physical activity, class III describes moderate heart failure with marked limitation of physical activity and class IV describes severe heart failure, when patients are unable to carry out any physical activity without discomfort. Treatment for chronic heart failure involves lifestyle changes such as increased physical activity and dietary restriction of salt and fluids. Pharmacological treatments include angiotensin-converting enzyme inhibitors, beta-blockers, aldosterone antagonists, angiotensin II receptor antagonists, hydralazine in combination with nitrate, and digoxin (see Chronic heart failure: management of chronic heart failure in adults in primary and secondary care [NICE clinical guideline 108]). Diuretics are used for the relief of congestive symptoms, such as breathlessness and leg swelling associated with heart failure. In some patients cardiac resynchronisation therapy is used. Monitoring of patients with chronic heart failure is done to identify signs of deterioration in order to modify treatment, with the aims of improving their quality of life and avoiding admission to hospital. This monitoring typically includes clinical assessment of functional capacity, fluid status (for example by measuring body weight), cardiac rhythm, and cognitive and nutritional status. Clinical monitoring and treatment in the community, usually by nurses, may reduce the incidence of complications and subsequent hospitalisation. Monitoring pulmonary artery pressure using an implantable device has been proposed as a method of monitoring the severity of heart failure and to provide early detection of worsening cardiac function. IP overview: insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Page 2 of 21

3 What the procedure involves The procedure for insertion and use of an implantable pulmonary artery pressure monitor varies according to the device being used. Insertion of implantable pulmonary artery pressure monitors is usually done under local anaesthesia. Using a percutaneous approach, commonly via the femoral vein, a passive radiofrequency sensor without batteries or leads is implanted into a distal branch of the pulmonary artery, with radiological guidance. The sensor is anchored within the artery. Data on pulmonary artery pressure are transmitted from the sensor to an external antenna, which may be housed in a pillow on which the patient can lie. The antenna is connected to a computer that transmits the data to a remote secure database, which can be accessed by the heart failure team. Transmission of data is usually done by the patient in their own home, typically once a day. Transmitted information consists of pressure trend information and pulmonary artery pressure waveforms. The aim of this procedure is to improve management of heart failure and reduce the rate of heart failure and related admissions to hospital. This would be achieved by using pressure trends to anticipate deterioration in cardiac function, and adjust therapy accordingly. Literature review Rapid review of literature The medical literature was searched to identify studies and reviews relevant to insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure. Searches were conducted of the following databases, covering the period from their commencement to 22 April 2013: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. IP overview: insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Page 3 of 21

4 Table 1 Inclusion criteria for identification of relevant studies Characteristic Publication type Patient Intervention/test Outcome Language Criteria Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patients with chronic heart failure. Insertion and use of implantable pulmonary artery pressure monitor. Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. List of studies included in the overview This overview is based on approximately 630 patients from 1 randomised controlled trial, 1 non-randomised controlled trial and 3 case series 1 5. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. IP overview: insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Page 4 of 21

5 Table 2 Summary of key efficacy and safety findings on insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Abbreviations used: CI, confidence interval; NNT, number needed to treat; NYHA, New York Heart Association. Study details Key efficacy findings Key safety findings Comments Abraham WT (2011) 1 Number of patients analysed: 550 (270 vs 280) Randomised controlled trial (CHAMPION trial) Device: pulmonary artery pressure monitor (Champion, CardioMEMS, USA) USA Recruitment period: Study population: patients with moderate heart failure for at least 3 months, and a hospitalisation for heart failure within the past 12 months n=550 (270 management with implantable monitor vs 280 control) Age: mean 61 years, Sex: 73% (399/550) male Patient selection criteria: aged 18 years, moderate (NYHA functional class III) heart failure for at least 3 months, irrespective of left ventricular ejection fraction or cause, and a hospitalisation for heart failure within the past 12 months. Exclusion criteria included a history of recurrent pulmonary embolism or deep venous thrombosis, cardiac resynchronisation with device implantation within the preceding 3 months, and stage IV or V chronic kidney disease. Technique: pulmonary artery pressure monitor (Champion, CardioMEMS, USA) was used (consisting of passive, radiofrequency sensor without batteries or leads, and external electronic reader). Follow-up: mean 15 months Conflict of interest/source of funding: authors include consultants to CardioMEMS, Medtronic, St Jude Medical and CHF Solutions, employees of CardioMEMS, and research grants were received from CardioMEMS, Medtronic, St Jude Medical and Gilead Number of heart failure-related hospitalisations up to 6 months (primary end point): Treatment group=84 Control group=120 Hazard ratio 0.72 (95% CI: 0.60 to 0.85), p<0.0001, NNT=8 Number of heart failure-related hospitalisations during entire randomised follow-up: Treatment group=158 Control group=254 Hazard ratio 0.63 (95% CI: 0.52 to 0.72), p<0.0001, NNT=4 Change from baseline in pulmonary artery mean pressure at 6 months (mmhgxdays; mean area under the curve): Treatment group=-156 Control group=33 p=0.008 Number of patients admitted to hospital for heart failure at 6 months: Treatment group=20% (55/270) Control group=29% (80/280) Relative risk 0.71 (95% CI: 0.53 to 0.96), p=0.03 Days alive outside hospital at 6 months (mean): Treatment group=174.4 Control group=172.1 p=0.02 Minnesota Living with Heart Failure Questionnaire at 6 months (mean): Serious adverse events : Device-related or systemrelated complications=1% (8/575) Procedure-related adverse events=1% (7/575) These events included: Groin haematomas (n=2) Epistaxis (n=1) Haemoptysis (n=1) Hospitalisation related to anticoagulation treatment (n=3) Prolonged hospitalisation secondary to resumption of therapeutic anticoagulation (n=1) Exacerbation of pre-existing atrial arrhythmias during right-heart catheterisation (n=2) Febrile illnesses (n=2) Pulmonary in situ thrombus during right-heart catheterisation (treated with anticoagulation) (n=1) Cardiogenic shock (n=1) Atypical chest pain (n=1) Delivery-system failure that needed a snare to remove the delivery system (n=1) There were no pressure sensor failures. failure Page 5 of 21 IP 972 [IPG463] Study design issues: Prospective, multicentre, single-blind randomised controlled trial. Patients in the control group had monitors implanted but access to the pulmonary artery pressure readings was blocked. Randomisation was done before hospital discharge. Patients were masked to their assignment group and all patients were asked to take pressure readings every day. These measurements were sent through a modem to a secure patient database. In the treatment group, drug changes were based on the sensor haemodynamic data as well as patients symptoms. In the control group, drug changes were made in response to patients clinical signs and symptoms. Investigators were aware of the assignment group and this may have introduced some bias. All analyses were by intention to treat. Study population issues: The groups were similar with respect to baseline characteristics. Other issues: An additional 25 patients had rightheart catheterisation but the device was not implanted; these patients were not enrolled in the study but were included in the safety outcome analysis. The authors noted that the rate of heart failure-related hospitalisations

6 Abbreviations used: CI, confidence interval; NNT, number needed to treat; NYHA, New York Heart Association. Study details Key efficacy findings Key safety findings Comments Sciences. Treatment group=45 Control group=51 p=0.02 Number of changes to drugs for heart failure: Treatment group=2468 (mean 9.1 per patient) Control group=1061 (mean 3.8 per patient) p< IP 972 [IPG463] was very low in the control group, reflecting the high-quality management provided by the trial sites. failure Page 6 of 21

7 Abbreviations used: CI, confidence interval; NNT, number needed to treat; NYHA, New York Heart Association. Study details Key efficacy findings Key safety findings Comments Hoppe UC (2009) 2 Number of patients analysed: 31 The location of all permanent implants remained stable at Case series (PAPIRUS II trial) fluoroscopic follow-up at 6 months. Device: pulmonary artery pressure monitor (ImPressure) Germany, Belgium, Israel Recruitment period: not reported Study population: patients with chronic heart failure (NYHA class III IV) n=40 Age: median 68 years, Sex: 70% (28/40) male Patient selection criteria: aged 18 years; NYHA class III or IV chronic heart failure. Technique: Pulmonary artery pressure monitoring system used (ImPressure, Remon Medical Technologies; now Boston Scientific) comprising a miniature pressure-sensor implant and an external hand-held unit that stores pulmonary artery pressure curves. Ultrasonic energy is used for communication between the external unit and the implant. The pressure monitor was permanently implanted in 78% (31/40) of patients (in 2 patients the device was recaptured percutaneously because the position was deemed to be unstable and in 7 patients the pulmonary artery anatomy was assessed as being unsuitable for permanent implantation). During the 6 months of follow-up, there were 16 admissions to hospital in 12 patients (3 for decompensated chronic heart failure, 4 for angina pectoris and 9 for non-cardiovascular causes). Two heart failure-related admissions occurred before the patient had received the home unit (in 1 of these patients, there was a transient increase in diastolic pulmonary artery pressure of 15 mmhg). 95% limits of agreement between pressure catheter and implanted monitor were -3 to 6.4 mmhg (n=10). All individual accuracy measurements were within the defined accuracy end point limits of 10 mmhg. Variations of pulmonary artery diastolic pressure were observed in relation to posture. 1 patient developed a mild contrast allergic reaction. The pressure sensor failed in 1 patient because of a fault in implant electronics (the problem was identified and fixed for all subsequent implants). Study design issues: Prospective, multicentre study. The pulmonary artery pressure waveforms were collected by handheld home units and downloaded to the clinic systems during clinic visits. The primary objective of the study was to demonstrate safety in the delivery system and during followup. Secondary end points included accuracy of the measured diastolic pulmonary artery pressure compared with a catheter reading (aim of absolute difference 10 mmhg). Follow-up: 6 months Conflict of interest/source of funding: Remon Medical Technologies, now part of Boston Scientific, funded the trial. Median compliance with home monitoring=86% (range %) failure Page 7 of 21

8 Abbreviations used: CI, confidence interval; NNT, number needed to treat; NYHA, New York Heart Association. Study details Key efficacy findings Key safety findings Comments Verdejo HE (2007) 3 Number of patients analysed: 12 There were no adverse effects associated with device Technical success=100% (12/12) implantation. Non-randomised comparative study (selfcontrolled) USA Recruitment period: not reported Study population: ambulatory patients with heart failure n=12 (implantable monitor vs fluid-filled catheter vs echocardiography) Age: mean 63 years, Sex: 92% (11/12) male Patient selection criteria: NYHA functional class III or IV heart failure. Exclusion criteria included recent acute coronary syndrome, coronary artery bypass surgery, or percutaneous coronary angioplasty within the last 3 months; mechanical right heart valves; pulmonary or tricuspid stenosis, pulmonary embolism, or pulmonary infarction within the last 3 months. Technique: Implantable haemodynamic monitoring system (CardioMEMS, USA) was used (consisting of passive, wireless radiofrequency sensor without batteries or leads, and external electronic reader). Follow-up: median 62 days (range ) Implantable monitor versus measurement by catheterisation Systolic pulmonary artery pressure at implantation Implantable monitor=64±22 mmhg Fluid-filled catheter=58±22 mmhg Correlation coefficients at implantation=0.90 Correlation coefficient at follow-up=0.94 Mean difference=6.2±4.5 mmhg Diastolic pulmonary artery pressure at implantation Implantable monitor=23±14 mmhg Fluid-filled catheter=28±16 mmhg Correlation coefficients at implantation=0.88 Correlation coefficient at follow-up=0.48 Mean difference=-1.6±6.8 mmhg Implantable monitor versus measurement by echocardiography Systolic pulmonary artery pressure at implantation Implantable monitor=60±20 mmhg Fluid-filled catheter=62±12 mmhg Correlation coefficients at implantation=0.75 Mean difference=-2.6±11 mmhg There was no significant variation over time in the difference between both methods. Study design issues: Prospective, multicentre study. The study was self-controlled by using paired data from the implantable monitor and a Swan- Ganz catheter, and echocardiography (for systolic pulmonary artery pressure). Measurement of pulmonary artery pressure by implantable monitor was done by 2 blinded evaluators. Echocardiography was done by a trained operator blinded for other measurements. Conflict of interest/source of funding: not reported Echocardiography determination of diastolic pulmonary artery pressure was only possible in 2 patients. failure Page 8 of 21

9 Abbreviations used: CI, confidence interval; NNT, number needed to treat; NYHA, New York Heart Association. Study details Key efficacy findings Key safety findings Comments Abraham WT (2011) 4 Number of patients analysed: 17 There were no reported cases of pulmonary infarction or Case series Technical success=100% (17/17) thromboembolism, vascular complications, or other adverse USA events related to the device during implantation or follow-up. Recruitment period: Study population: patients with symptomatic heart failure n=17 Age: mean 61 years (range 44 86) Sex: 82% (14/17) male Patient selection criteria: age>18 years, stable NYHA class III heart failure for at least 30 days before enrolment, estimated life expectancy of at least 1 year. Exclusion criteria: medically unstable, unable to tolerate right-heart catheterisation, likely to undergo heart transplantation or cardiac surgery within 2 months of enrolment, permanent indwelling central venous catheter, history of myocardial infarction, unstable angina, stroke, transient ischaemic attacks or intractable arrhythmias within the preceding 2 months. Other exclusion criteria included a history of congenital heart disease or prosthetic right-heart valve, history of deep venous thrombosis or pulmonary emboli, unstable hypertension, known coagulopathy, hypersensitivity to aspirin and/or clopidogrel, active lung infection, elevated white blood count, chronic renal insufficiency. Technique: Implantable haemodynamic monitoring system (CardioMEMS, USA) was used (consisting of passive, wireless radiofrequency sensor without batteries or leads, and external electronic reader). Follow-up: 60 days Conflict of interest/source of funding: study was funded by CardioMEMS Inc (USA) There was excellent agreement between the pulmonary artery pressure sensor and Swan- Ganz catheter for systolic, diastolic and mean pulmonary artery pressures with correlation coefficients of 0.94, 0.85 and 0.95 respectively (all p values <0.0001). The average difference for systolic, diastolic and mean pulmonary artery pressures for the implanted sensor in comparison with the Swan-Ganz catheter was -4.4±0.3, 2.5±1.0 and -0.8±1.3 mmhg respectively. The overall daily patient adherence to home monitoring was 90% (871/968 days) in the 60 days after implantation. One patient died on day 50 after implantation of pulmonary artery pressure monitor the investigator determined that the death was unrelated to the study device or procedure. A post-mortem analysis of the sensor in a patient who died 12 months after implantation demonstrated complete endothelialisation and no evidence of thrombosis. Study design issues: The study was designed to establish the safety and feasibility of implantable pulmonary artery pressure monitoring. Study population issues: 11 patients had pre-existing implanted cardioverter/defibrillator or cardiac resynchronisation therapy devices in place. failure Page 9 of 21

10 Abbreviations used: CI, confidence interval; NNT, number needed to treat; NYHA, New York Heart Association. Study details Key efficacy findings Key safety findings Comments Rozenman Y (2007) 5 Number of patients analysed: 10 (1 patient was excluded after enrolment because No device-related complications occurred during 6 months of Case series pulmonary angiography revealed a pulmonary follow-up. artery diameter >25 mm) India Recruitment period: not reported Study population: patients with chronic heart failure n=11 Age: mean 45 years (range 25 58) Sex: 91% (10/11) male Patient selection criteria: patients with class III or IV chronic heart failure. Exclusion criteria included patients with pacemakers, creatinine >2.5 mg/dl, expected survival <6 months. Technique: Implantable acoustic haemodynamic monitoring system (Remon Medical Technologies, USA) was used (consisting of a pressure sensor without wires, and external communication/analysis unit). Follow-up: 6 months Conflict of interest/source of funding: study was supported by Remon Medical Technologies, Israel. Implantation was successful in 10 patients. Pressure measurements were successfully obtained from all implants. Study design issues Pilot trial. The authors note that the device used in this trial contains no energy source and needs to be charged before use. It is, therefore, not suitable for home monitoring. Future designs include a miniature battery, which simplifies interrogation and makes the system suitable for home monitoring. failure Page 10 of 21

11 Efficacy Heart failure-related hospitalisations A randomised controlled trial of 550 patients treated by management with pulmonary artery pressure monitoring or standard management reported 84 and 120 heart failure related hospitalisations, respectively at 6 months follow-up (p<0.0001) 1. During the entire follow-up (mean 15 months) there were 158 heart failure related hospitalisations in the treatment group versus 254 in the control group (p<0.0001). Survival The randomised controlled trial of 550 patients reported 174 and 172 mean days alive outside hospital in the pressure monitor and control groups respectively at 6-month follow-up (p=0.02) 1. Quality of life The randomised controlled trial of 550 patients treated by management with pulmonary artery pressure monitoring or standard management reported mean scores of 45 and 51, respectively, on the Minnesota Living with Heart Failure Questionnaire (lower scores indicate a better quality of life, a 5-point difference is stated as the minimally important difference by the scale developers) at 6-month follow-up (p=0.02) 1. Safety System-related complications Delivery-system failure that needed a snare to remove the delivery system was reported in 1 patient in the randomised controlled trial of 550 patients 1. Pressure sensor failure was reported in 1 patient in a case series of 40 patients at 6-month follow-up 2. Cardiac complications Cardiogenic shock was reported in 1 patient in the randomised controlled trial of 550 patients 1. Exacerbation of pre-existing atrial arrhythmias during right-heart catheterisation was reported in less than 1% (2/550) of patients in the same study 1. Infection Febrile illness was reported in less than 1% (2/550) of patients in the randomised controlled trial of 550 patients 1. failure Page 11 of 21

12 Thromboembolism Pulmonary in situ thrombus during right-heart catheterisation (treated with anticoagulation) was reported in 1 patient in the randomised controlled trial of 550 patients 1. Validity and generalisability of the studies The randomised controlled trial reported a lower rate of heart-failure events in the control population than expected 1. The procedures in this study were done at centres with dedicated heart-failure programmes. It is likely that the increased patient contact in this trial contributed to the lower than expected event rate observed. Existing assessments of this procedure There were no published assessments from other organisations identified at the time of the literature search. Related NICE guidance Below is a list of NICE guidance related to this procedure. Appendix B gives details of the recommendations made in each piece of guidance listed. Technology appraisals Cardiac resynchronisation therapy for the treatment of heart failure. NICE technology appraisal guidance 120 (2007). Clinical guidelines Chronic heart failure: management of chronic heart failure in adults in primary and secondary care. NICE clinical guideline 108 (2010). Specialist Advisers opinions Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. The advice received is their individual opinion and does not represent the view of the society. Professor Andrew Clark, Professor Martin Cowie (British Cardiovascular Society); Professor John Cleland, Dr Roy Gardner, Dr Simon Williams (British Society for Heart Failure) failure Page 12 of 21

13 None of the specialist advisers have performed the procedure. Four specialist advisers consider the procedure to be the first in a new class of procedure; 1 specialist adviser considers the procedure to be definitely novel and of uncertain safety and efficacy. Two specialist advisers stated that the Food and Drug Administration (FDA) did not approve use of the Champion device in December In addition, a third Specialist Adviser noted that the FDA raised concerns about the CHAMPION trial. Comparators to this procedure include other forms of home monitoring such as weight scales, pacemaker readings (remote monitoring), hospital visits, heart failure nurse review, standard (optimal) heart failure pharmacological therapy, and right-heart catheterisation. Theoretical adverse events include embolism of the device into the peripheral pulmonary tree, infection, pulmonary embolism, rupture of branch pulmonary artery, movement of the device, faulty communication of data, and errors in clinical decision-making based on measurements (even if the measurements are accurate). Anecdotal adverse events include excessive reduction in blood pressure and renal dysfunction caused by aggressive treatment of pulmonary artery pressure. Key efficacy outcomes include reduction in heart failure-related hospitalisations, improved quality of life, and reduced mortality. There are uncertainties about the efficacy of the procedure. Three specialist advisers considered the procedure to potentially have a moderate impact on the NHS, in terms of numbers of patients eligible for treatment and use of resources; 1 specialist adviser thought the potential impact was major and 1 thought the potential impact was minor. Patient Commentators opinions NICE s Patient and Public Involvement Programme was unable to gather patient commentary for this procedure. failure Page 13 of 21

14 Issues for consideration by IPAC There are a number of other implantable intravascular or intracardiac devices available, which measure right ventricular pressure or left atrial pressure. failure Page 14 of 21

15 References 1. Abraham WT, Adamson PB, Bourge RC et al. (2011) Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 377: Hoppe UC, Vanderheyden M, Sievert H et al. (2009) Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: multicentre experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II study. Heart 95: Verdejo HE, Castro PF, Concepcion R et al. (2007) Comparison of a radiofrequency-based wireless pressure sensor to swan-ganz catheter and echocardiography for ambulatory assessment of pulmonary artery pressure in heart failure. Journal of the American College of Cardiology 50: Abraham WT, Adamson PB, Hasan A et al. (2011) Safety and accuracy of a wireless pulmonary artery pressure monitoring system in patients with heart failure. American Heart Journal 161: Rozenman Y, Schwartz RS, Shah H et al. (2007) Wireless acoustic communication with a miniature pressure sensor in the pulmonary artery for disease surveillance and therapy of patients with congestive heart failure. Journal of the American College of Cardiology 49: failure Page 15 of 21

16 Appendix A: Additional papers on insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure The following table outlines the studies that are considered potentially relevant to the overview but were not included in the main data extraction table (table 2). It is by no means an exhaustive list of potentially relevant studies. Article Number of patients/ Direction of conclusions Reasons for noninclusion in table 2 follow-up Castro PF, Concepcion R, Bourge RC et al. (2007) A wireless pressure sensor for monitoring pulmonary artery pressure in advanced heart failure: initial experience. The journal of heart and lung transplantation 26: 85 8 Case report n=1 The results of pulmonary artery pressure obtained by the sensor were similar to echo-doppler and Swan-Ganz measurements. There were no complications. The patient improved from NYHA class IV status to class III without further heart failurerelated hospital admissions. Case report. Klersy C, De Silvestri A, Gabutti G et al. (2009) A meta-analysis of remote monitoring of heart failure patients. Journal of the American College of Cardiology 54: Review and meta-analysis n=8612 All remote patient monitoring systems Remote patient monitoring conferred a significant protective clinical effect in patients with chronic heart failure compared with usual care. Included all types of remote patient monitoring (remote external, wearable or implantable electronic devices). failure Page 16 of 21

17 Appendix B: Related NICE guidance for insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Guidance Technology appraisals Recommendations Cardiac resynchronisation therapy for the treatment of heart failure. NICE technology appraisal guidance 120 (2007). This guidance should be read in conjunction with 'Implantable cardioverter defibrillators for arrhythmias' (NICE technology appraisal guidance 95 see appendix C). This guidance on cardiac resynchronisation therapy provides additional treatment options for some of the groups of people covered in the guidance on implantable cardioverter defibrillators (ICDs) 1.1 Cardiac resynchronisation therapy with a pacing device (CRT- P) is recommended as a treatment option for people with heart failure who fulfil all the following criteria. Clinical guidelines They are currently experiencing or have recently experienced New York Heart Association (NYHA) class III IV symptoms. They are in sinus rhythm: o either with a QRS duration of 150 ms or longer o estimated by standard electrocardiogram (ECG) or with a QRS duration of ms estimated by ECG and mechanical dyssynchrony that is confirmed by echocardiography. They have a left ventricular ejection fraction of 35% or less. They are receiving optimal pharmacological therapy. 1.2 Cardiac resynchronisation therapy with a defibrillator device (CRT-D) may be considered for people who fulfil the criteria for implantation of a CRT-P device in section 1.1 and who also separately fulfil the criteria for the use of an ICD device as recommended in NICE technology appraisal guidance 95. Chronic heart failure: management of chronic heart failure in adults in primary and secondary care. NICE clinical guideline 108 (2010). 1.4 Monitoring Clinical review All patients with chronic heart failure require monitoring. This monitoring should include: a clinical assessment of functional capacity, fluid status, cardiac rhythm (minimum of examining the pulse), cognitive status and nutritional status a review of medication, including need for changes and possible side effects serum urea, electrolytes, creatinine and egfr*. [2003, failure Page 17 of 21

18 amended 2010] More detailed monitoring will be required if the patient has significant comorbidity or if their condition has deteriorated since the previous review. [2003] The frequency of monitoring should depend on the clinical status and stability of the patient. The monitoring interval should be short (days to 2 weeks) if the clinical condition or medication has changed, but is required at least 6-monthly for stable patients with proven heart failure. [2003] Patients who wish to be involved in monitoring of their condition should be provided with sufficient education and support from their healthcare professional to do this, with clear guidelines as to what to do in the event of deterioration. [2003] When a patient is admitted to hospital because of heart failure, seek advice on their management plan from a specialist in heart failure. [new 2010] * This is a minimum. Patients with comorbidities or co-prescribed medications will require further monitoring. Monitoring serum potassium is particularly important if a patient is taking digoxin or an aldosterone antagonist. failure Page 18 of 21

19 Appendix C: Literature search for insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure Databases Date searched Version/files No. retrieved Cochrane Database of Systematic 22/04/2013 Issue 3 of 12, Mar Reviews CDSR (Cochrane Library) Database of Abstracts of Reviews 22/04/2013 Issue 1 of 4, Jan of Effects DARE HTA database 22/04/2013 Issue 1 of 4 Jan Cochrane Central Database of 22/04/2013 Issue 3 of 12, March Controlled Trials CENTRAL (Cochrane Library) MEDLINE (Ovid) 22/04/2013 Ovid MEDLINE(R) 1946 to 10 April Week MEDLINE In-Process (Ovid) 22/04/2013 Ovid MEDLINE(R) In- 9 Process & Other Non- Indexed Citations April 19, 2013 EMBASE (Ovid) 22/04/ to 2013 Week CINAHL (NLH Search 2.0 or EBSCOhost) 22/04/ Trial sources searched on 15/11/2012 Current Controlled Trials metaregister of Controlled Trials mrct Clinicaltrials.gov National Institute for Health Research Clinical Research Network Coordinating Centre (NIHR CRN CC) Portfolio Database Websites searched National Institute for Health and Clinical Excellence (NICE) Food and Drug Administration (FDA) - MAUDE database French Health Authority (FHA) Australian Safety and Efficacy Register of New Interventional Procedures Surgical (ASERNIP S) Australia and New Zealand Horizon Scanning Network (ANZHSN) Conference search Evidence Updates (NHS Evidence) General internet search failure Page 19 of 21

20 The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases. 1 heart failure/ 2 cardiomyopathy, dilated/ 3 shock, cardiogenic/ 4 ventricular dysfunction/ 5 cardiac output, low/ 6 ((heart* or cardiac* or myocardial or cardio* or ventric*) adj3 (failure or decompensation or insufficient* or dysfunct* or "stand still")).tw. 7 ((congestive or chronic) adj3 "heart failure").tw. 8 ((dilated or congestive) adj3 cardiomyopath*).tw. 9 "cardiogenic shock".tw. 10 (("left ventricular" or "left ventricle") adj3 (failure or insufficien* or dysfunction*)).tw. 11 (lvsd or hf or chf).tw. 12 or/ exp telemetry/ 14 Wireless Technology/ 15 wireless*.tw. 16 (telemetr* or biotelemetr* or radiotelemet* or teleradiometr* or telemonitor*).tw. 17 telemedicine/ 18 (telemed* or telehealth or ehealth).tw. 19 electrodes, implanted/ 20 (implant* adj3 (electrode* or sensor* or pressur*)).tw. 21 "Prostheses and Implants"/ 22 ((implant* or prosthe*) adj3 (pulmonary arter* or pulmonary valve* or pulmonary trunk*)).tw. 23 blood vessel prosthesis/ failure Page 20 of 21

21 24 blood vessel prosthesis implantation/ 25 or/ blood pressure monitoring, ambulatory/ 27 ((pulmonary or heart or blood) adj3 pressur* adj3 (monitor* or measure* or determination* or record*)).tw. 28 (continuous adj3 ambulatory adj3 (monitor* or pressur*)).tw. 29 monitoring, physiological/ 30 (physiologic* adj3 (monitor* or measure*)).tw. 31 hemodynamics/ 32 (hemodynamic* or haemodynamic*).tw. 33 pulmonary wedge pressure/ 34 (wedge adj3 pressur*).tw. 35 blood pressure determination/ 36 or/ ((champion or chronicle) adj3 (heart or cardia* or sensor* or implant*)).tw. 38 (remon or cardiomems).tw or and 25 and or Animals/ not Humans/ not 42 failure Page 21 of 21