Patients undergoing heart valve replacement have a high risk of experiencing valve related adverse events such as acute failure of the valve mechanism, valve thrombosis, and peripheral emboli. Immediate availability of information about valves for any valve patient presenting at outpatient clinics, general practitioner surgeries, or acutely at accident and emergency departments may lead to early suspicion and diagnosis of specific complications known to be associated with particular heart valves.1–3 Postoperative surveillance is therefore crucial.
Valve manufacturers have established schemes to provide patients with cards that give details of the valve prosthesis. The process has four to five steps and can fail at any stage, for example when the implanting centre sends implant details to the valve manufacturer (usually via the UK distributor), or when the valve manufacturer sends the implant card to the patient via the implanting centre.
Clinicians have been concerned that current distribution systems may be less than optimal; although valve card schemes have been in place for many years, they have not been independently evaluated. We surveyed a cohort of UK patients who had had heart valves replaced to determine what proportion received an implant card, and when they received it relative to their implant date.
Methods and results
The UK heart valve registry prospectively collects data on all valve replacements carried out in the United Kingdom.4,5 Currently >79 000 patients and >88 000 heart valves are registered. Patients who underwent heart valve replacement between 1 January 1998 and 31 December 1998 were identified from the database and checked against national registers (England, Scotland, Wales, and Northern Ireland) for deceased patients and those lost to follow up. The 2582 patients identified were sent an anonymised questionnaire and asked the date of their operation, if they had received an implant card, and the interval between operation and card receipt.
A total of 1914 patients (74%) responded to the questionnaire. Of these, 47% (n=898) had not received an implant card 12 months postoperatively (figure). In all, 14% had received their implant card one month postoperatively, 30% three months postoperatively, and 43% six months postoperatively. A small number of patients (⩽1%) could not remember how long after surgery the card had arrived. 45% identified themselves and were matched against valve manufacturer and implanting centre; 60% of these (n=519) did not receive an implant card. Three of nine valve manufacturers achieved >50% (range 53-71%) success in getting implant cards to patients within a year postoperatively; the remainder achieved 0-45% success. Although certain patients were identified against their individual implanting centre, it seems that some implanting centres are better than others at forwarding implant cards to patients.
Comment
Present implant card schemes are falling well below acceptable standards. Nearly half of the patients sampled had not received an implant card 12 months postoperatively. Furthermore, patients who had not received the implant card by six months postoperatively were unlikely ever to do so. It would be unfair, however, to blame valve manufacturers alone. Implanting hospitals may fail to send details to the manufacturer or the card to the patient.
We believe that the situation could easily be improved. Currently, UK cardiac centres send implant details to the heart valve registry. Authorising the registry to send the implant card to the patient would remove the manufacturer and clinician from the process. The manufacturer would receive anonymised implant information for postmarket surveillance and patients would receive their cards quickly. This centralised system would be cost effective, could be financed through a small charge per valve implanted, and would contribute to patient surveillance.
Supplementary Material
Figure.
Implant cards received by patients over time
Acknowledgments
We are grateful to all staff involved with the UK heart valve registry for assimilating and maintaining the national database. All participating hospitals do so voluntarily (see BMJ 's website for a list of hospitals involved).
Footnotes
Funding: None.
Competing interests: None declared.
A list of participating hospitals is available on the BMJ's website
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