Overview
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Summary of key evidence on PEARS using mesh to prevent aortic root expansion and aortic dissection in people with Marfan syndrome
Study 1 Van Hoof L (2021)
Study type | Cohort study |
|---|---|
Country | Not reported (data were from 23 centres, including the UK) |
Recruitment period | 2004 to 2019 |
Study population and number | n=200 (147 with Marfan syndrome) Patients who had surgery with intent to use PEARS for primary aortic root dilatation. |
Age and sex | Median 33 years (range 3 to 75 years); 69% (138/200) male |
Patient selection criteria | Not reported |
Technique | Prophylactic treatment with PEARS (ExoVasc personalised mesh support, Exstent Ltd.). 28 patients had concomitant procedures, including mitral valve repair (n=20) and off pump coronary artery bypass grafting (n=3). For 166 isolated aortic PEARS cases, cardiopulmonary bypass was used in 21.1%. |
Follow-up | Median 21.2 months (range 0 to 190.5 months); clinical follow-up beyond 12 months was available for 72.1% (142/197) of patients. |
Conflict of interest/source of funding | One author is the inventor of the ExoVasc device. He was the first patient to have PEARS surgery in 2004 and is a shareholder in Exstent Ltd. |
Analysis
Follow-up issues: Of the 200 patients, 3 (1.5%) were lost to follow up.
Study design issues: Multicentre cohort study evaluating all consecutive patients who had surgery with an intention to perform PEARS for aortic root dilatation. Perioperative outcomes were collected prospectively and clinical follow-up was retrieved retrospectively. Surgeons were asked to provide detailed demographics, in-hospital outcomes and clinical follow-up data via anonymised spreadsheets.
Study population issues: Most patients (73.5%) had Marfan syndrome. Other indications were bicuspid aortic valve (8.5%), Loeys-Dietz syndrome (7.5%), ACTA2 mutation (1%) and idiopathic or other (9.5%). The preoperative aortic regurgitation grade was 0 or 0.5 (none or trivial) in 74.2% (147/198) of patients and 1 or 2 (mild or moderate) in 25.8% (51/198) of patients. The overall median root diameter was 47 mm (range 28 to 60 mm). For the 147 patients with Marfan syndrome, the median root diameter was 47 mm.
Key efficacy findings
Number of patients analysed: 200
Technical success
PEARS completed=97.0% (194/200)
Intraoperative conversion to total root replacement or valve-sparing root replacement=2.5% (5/200)
Procedure abandoned=0.5% (1/200)
Aortic events
No ascending aortic dissections were observed.
A new type B dissection was identified on imaging at 3 year follow-up in 1 asymptomatic patient.
Survival
Late deaths=2.0% (4/200); 1 patient died of heart failure unrelated to PEARS at 7 months postoperatively, 1 patient died from an unknown cause at 14 months, 1 patient died from COVID-19 at 3 years, and the other died in his sleep 4.5 years after the PEARS procedure.
Kaplan-Meier estimates of survival at 1, 2 and 3 years=98.3%, 97.6% and 97.6%
Successful pregnancy
9 patients had 1 or more successful pregnancies without cardiovascular complications after the procedure.
Reoperation
Late reoperation for failure to achieve complete coverage by the implant=1.5% (3/200)
Key safety findings
Perioperative adverse events
Mortality=0.5% (1/200); the patient had Marfan syndrome and a severe pectus deformity. The procedure was abandoned after the left main stem was injured.
Intervention for ischaemia or coronary injury=5.5% (11/200); coronary impingement was caused by the implant in 2 patients and coronary injury happened in 6 patients. In 3 patients, the adverse event was not caused by the implant.
Myocardial infarction=2.5% (5/200)
Intraoperative aortic dissection=0.5% (1/200) (treated conservatively)
Cerebrovascular event with hemiparesis=1.0% (2/200) (attributed to atrial fibrillation after off-pump PEARS; both patients recovered completely)
Study 2 Pepper J (2020)
Study type | Cohort study |
|---|---|
Country | Not reported (data were from 14 surgical teams, including the UK) |
Recruitment period | 2004 to 2017 |
Study population and number | n=117 Patients with life threatening aortic root aneurysm |
Age and sex | Not reported |
Patient selection criteria | Inclusion criteria: aortic root/sinus of Valsalva and ascending aorta asymptomatic dilation of 40 to 50 mm in diameter in patients aged 16 and over. Patients with more than mild aortic regurgitation were excluded. |
Technique | Prophylactic treatment with PEARS (ExoVasc personalised mesh support, Exstent Ltd.). 73% of procedures were done without cardiopulmonary bypass. An undersized mesh (95%) was used in some patients to correct aortic regurgitation. Of the 117 patients, 97 (83%) had personalised aortic root support alone, 12 patients also had mitral valve repair and 3 patients also had coronary artery bypass graft surgery. The operation was converted to a different procedure in 4 patients and was aborted in 1 patient. |
Follow-up | At least 1 year (range 2 to 12 years) |
Conflict of interest/source of funding | One of the authors is the inventor of the device. He was the first patient to have the procedure in 2004, and is a shareholder in Exstent Ltd. |
Analysis
Follow-up issues: The follow up interval was from the date of surgery to the date on which the patient was last clinically assessed or had cardiac investigations. Relatively few patients had long term follow up because most patients were recruited in more recent years. There were no losses to follow up.
Study design issues: Retrospective analysis of prospectively collected multicentre data. The Kaplan-Meier method was used to estimate survival and reoperation rates. Follow up included annual MRI scans.
Study population issues: Of the 177 patients, 94 (80%) had Marfan syndrome. Other aetiologies included Loeys Dietz (n=5), bicuspid aortic valve (n=8), non-syndromic (n=9) and post-mechanical aortic valve replacement (n=1). About 25% of patients had some aortic regurgitation before the procedure.
Key efficacy findings
Number of patients analysed: 117
Survival
At the time of reporting, 94.0% (110/117) of patients were alive with PEARS only, 1.7% (2/117) of patients were alive after revision surgery for progression of aortic regurgitation (at 93 and 105 months) and 1.7% (2/117) of patients had died (1 at day 5, which is described in the safety section below, and the other at 4.5 years after the procedure, which was related to arrhythmia).
In the 2 patients who had progression of aortic regurgitation and needed revision surgery, the right and non-coronary sinuses were not completely covered by the mesh because of deviations from the protocol for intraoperative reasons.
Key safety findings
Perioperative adverse events
Repositioning of external support, n=1
Release of sleeve, n=1
Coronary injury, n=1
Perioperative transient ischaemic attack related to atrial fibrillation, n=2
Intraoperative ischaemic events, n=2 (resulting in 19- and 25-day hospital stays)
Death, n=1 (at day 5, caused by damage to the left main stem at operation; also described above)
Apart from the patient who died, all 7 patients who had perioperative complications made a complete recovery.
There were no major bleeding events and only 1 superficial wound infection.
Study 3 Treasure T (2014)
Study type | Cohort study (and comparison with published meta-analysis) |
|---|---|
Country | UK and Belgium |
Recruitment period | 2004 to 2011 |
Study population and number | n=30 Patients with Marfan syndrome |
Age and sex | Mean 32 years; 67% (20/30) male |
Patient selection criteria | Inclusion criteria were that patients should have little or no aortic regurgitation, and an ascending aortic root diameter of 40 to 45 mm. All patients had at least 1 year of follow up. |
Technique | PEARS procedure. One patient had corrective surgery of a pectus excavatum at the time of the aortic root surgery. |
Follow-up | Mean 4.4 years (range 1.4 to 8.8 years) |
Conflict of interest/source of funding | One author is a shareholder and director of Exstent Ltd, which holds the Intellectual Property in the Personalised External Aortic Root Support project, the originator of the concept and the first recipient of the treatment. One author, as PhD student, worked on software development for CAD modelling (computer aided design), and continues to do this work for Exstent Ltd who manufacture the personalised supports. The project has been funded, to date, by Exstent Limited, a private limited liability company registered in the UK in July 2002. |
Analysis
Follow-up issues: There were no losses to follow up.
Study design issues: Results from the first 30 patients to have a PEARS procedure were compared with a published meta-analysis of 1,385 patients who had aortic root replacement (Benedetto et al., 2011). Survival and the incidence of aortic valve-related events were compared between the 2 studies. Kaplan-Meier analysis was used for overall non-parametric survival estimates. Linearised occurrence rates were calculated by dividing the number of events by accumulated patient years and expressed as % per patient year.
Study population issues: Of the 30 patients, 29 were in NYHA class 1, and were either working or pursuing full-time study. One patient was in NYHA class 3 and unfit for work because of comorbidity predating surgery and unrelated to his aortic root disease. 87% (26/30) of patients were on medication, mostly protective treatment for their Marfan aortic disease: 19 patients were on beta blocker medication, 3 patients had ACE inhibitor or angiotensin II antagonist medication, 2 patients combined beta blocker medication with an ACE inhibitor or angiotensin II antagonist. One patient was on antidepressants and 1 was on warfarin, diuretics and beta blocker therapy. Mild aortic regurgitation was reported in 27% (8/30) patients before the procedure, 70% (21/30) had no aortic regurgitation and data was missing for 1 patient. The mean preoperative aortic root diameter was 46.2 mm (range 40 to 54 mm).
Other issues: The authors noted that patients with severe aortic regurgitation are more likely to have total root replacement and are not candidates for external support of the aortic root using mesh, so cannot be directly compared. The external support is used at smaller aortic root size, and therefore, earlier in progression of the aortopathy than standard treatments.
Key efficacy findings
Number of patients analysed: 30
Outcome | Result |
|---|---|
Procedural duration, mean (range) | 160 minutes (85 to 414 minutes) |
Cardiopulmonary bypass, n (%); minutes | 1 (3%); 20 minutes |
Blood loss (n=27), mean (range) | 287 ml (50 to 950 ml) |
Blood products, n (%) | Blood 1 (3%); fresh frozen plasma 1 (3%); other 2 (6%) |
Intensive care unit stay, mean (range) | 25 hours (0 to 71 hours) |
Postoperative hospital stay, mean (range) | 6.6 days (4 to 16 days) |
Total hospital stay, mean (range) | 9.0 days (5 to 33 days) |
Cumulative survival at 7 years=100%
During follow up, there were no cerebrovascular, aortic or valve-related events.
There was 1 late death after completion of the analysis. A patient operated on in December 2008 at the age of 26 with an aortic diameter of 42 mm was found dead in bed in May 2013. The aorta and valve were intact and the external support was closely applied and firmly adherent to the aorta. There was no evidence of dissection. The coronaries were free of disease and without evidence of thrombosis or any other abnormality. The forensic pathologist found no cause of death but presumed this was a sudden cardiac death in the context of Marfan syndrome.
Outcome | PEARS (n=30) | Total root replacement (n=972) | Valve-sparing root replacement (n=413) |
|---|---|---|---|
Mean patient age, years (SD) | 31 (12) | 35 (0.5) | 33 (0.64) |
Mean preoperative aortic root diameter, mm (SD) | 46.2 (3.4) | 61 (0.7) | 52 (0.3) |
Proportion of patients with dissection | 0 | 0.30 (0.01) | 0.18 (0.02) |
Early mortality, % (95% CI) | 0 | 4.1% (1.9 to 7.7) | 3.2% (0.5 to 17.9) |
Reintervention on aortic valve, % per year (95% CI) | 0 | 0.3% per year (0.1 to 0.5) | 1.3% per year (0.3 to 2.2) |
Thromboembolic event, % per year (95% CI) | 0 | 0.7% per year (0.5 to 0.9) | 0.3% per year (0.1 to 0.6) |
Endocarditis, % per year (95% CI) | 0 | 0.3% per year (0.2 to 0.5) | 0.2% per year (0 to 0.3) |
Composite valve-related event, % per year (95% CI) | 0 | 1.3% per year (0.6 to 2.0) | 1.9% per year (0.8 to 2.9) |
Key safety findings
Perioperative serious adverse events
1 patient had recurrent ischaemia on several attempts to close the suture line in the external support. It was known that there was a small non-dominant right coronary artery, which raised the suspicion of short left main coronary anatomy. The chest was closed and the patient recovered. Coronary angiography confirmed the suspicion, and with the imaging available, the support was safely positioned a few days later.
1 patient had a ventricular fibrillation arrest in the intensive care unit. The emergency team released the closing suture, and the heart rhythm became stable with restoration of a normal ECG. Subsequent imaging showed the aortic dimensions to be stable.
Although there were no perioperative deaths in the first 30 patients included in the planned analysis, there was a subsequent postoperative death of the intended 34th patient, 5 days after surgery. The left main coronary artery was tortuous with an upward loop and was injured during the surgical dissection. Access was limited because of severe pectus excavatum. The situation was rapidly retrieved with a suture but transoesophageal echocardiography showed turbulent flow and loss of myocardial contractility. Cardiopulmonary bypass was instated, and an internal mammary artery graft placed. The aorta was opened, and the coronary orifice inspected. Excellent flow was confirmed in the native vessel and in the graft, but myocardial contractility did not recover as expected, and myocardial stunning was thought to be a factor. The external support was not positioned. Biventricular support was instituted, and after 3 to 4 days, there was good myocardial recovery, but 5 days after surgery, there was acute onset fixed dilation of the pupils caused by an intracerebral bleed.
Serious adverse events
1 patient had exercise-induced constricting chest pain 6.7 years after the procedure (linearised occurrence rate 0.75% per patient year). It was found to be unrelated to the aortic root pathology or surgery. Coronary angiography showed an atherosclerotic left anterior descending coronary artery stenosis which was successfully stented. Aortography and coronary angiography done at that time showed widely patent coronary orifices with no sign of impingement of the external support on the smooth lumen of his coronary arteries.
Study 4 Izgi C (2018)
Study type | Case series |
|---|---|
Country | UK |
Recruitment period | 2004 to 2012 |
Study population and number | n=24 Patients with Marfan syndrome |
Age and sex | Mean 33 years (range 16 to 58 years); 67% (16/24) male |
Patient selection criteria | Eligibility criteria were an aortic root size of 40 to 55 mm and no or only mild aortic regurgitation. |
Technique | Device: (ExoVasc Personalized External Aortic Root Support, Exstent Limited, UK) |
Follow-up | Mean 6.3 ± 2.6 years (79% [19/24] of patients had at least 5 years of follow up) |
Conflict of interest/source of funding | None |
Analysis
Follow-up issues: An additional 3 patients were treated during the study period but were excluded from the analysis. In 2 of these patients, the baseline and follow up imaging was by CT (1 patient had metallic spinal roads that caused significant artefacts and 1 patient had severe claustrophobia that precluded imaging by CMR). The third patient was living abroad and follow up imaging studies were not available.
Study design issues: Prospective single centre case series. The main aim of the study was to test stability of the aortic root size after the procedure, based on measurements by CMR. Patients had CMR before the operation, at 6 and 12 months after the operation and annually thereafter. A batch of 120 anonymised CMR studies was formed, including the baseline and the latest CMR studies of all the 24 patients as well as randomly selected studies of the patients acquired at any time during their follow up to try and minimise any possible measurement bias. A single operator measured the aorta size on these individual anonymised studies following a stringent, pre-defined protocol.
Study population issues: The mean of the largest aortic root diameter was 44.9 mm (range 41 to 52 mm).
Other issues: The authors noted that the cutoff size of 40 mm is lower than the recommended cutoff size for aortic root replacement, because the procedure was developed as a prophylactic surgery to prevent dilatation of the aortic root at an early point in the natural history of Marfan syndrome.
Key efficacy findings
Number of patients analysed: 24
Technical failure=8.3% (2/24); the mesh support did not fully cover the aortic root because of identifiable technical failures. These 2 patients were taken as outliers. In 1 patient, ischaemia with compromise of right coronary flow was suspected after the procedure. The chest was urgently reopened, and the seam of the mesh support was opened to release any possible impingement on the coronary arteries. The aortic root dilated in the uncovered area at follow up. In the second patient, there was localised dilation of the right coronary cusp of the aortic root where the opening for the coronary ostia was inadvertently cut large, leaving this region not adequately supported.
Measurement | Preoperative | Follow up | Change | 95% CI | p value |
|---|---|---|---|---|---|
Annulus diameter, mm | 28.9 (2.2) | 28.4 (2.3) | -0.42 | -1.03 to 0.19 | 0.17 |
Sinus of Valsalva maximum diameter, mm | 44.9 (2.8) | 45.4 (4.0) | 0.50 | -0.97 to 1.97 | 0.49 |
Sinus of Valsalva mean diameter, mm | 43.6 (2.3) | 43.9 (3.8) | 0.36 | -0.92 to 1.64 | 0.57 |
Sinus of Valsalva area, cm2 | 16.3 (1.9) | 16.5 (2.9) | 0.11 | -0.85 to 1.06 | 0.82 |
Ascending aorta diameter, mm | 32.4 (3.5) | 32.4 (3.5) | 0.00 | -0.78 to 0.78 | 1.00 |
Ascending aorta area, cm2 | 8.2 (1.7) | 8.5 (1.8) | 0.23 | -0.14 to 0.60 | 0.21 |
Arch diameter, mm | 24.2 (2.0) | 24.6 (2.7) | 0.38 | -0.54 to 1.29 | 0.40 |
Descending aorta diameter, mm | 22.6 (2.5) | 23.9 (3.1) | 1.25 | 0.65 to 1.85 | <0.001 |
Descending aorta area, cm2 | 4.0 (0.9) | 4.4 (1.0) | 0.35 | 0.13 to 0.57 | 0.003 |
Measurement | Preoperative | Follow up | Change | 95% CI | p value |
|---|---|---|---|---|---|
Annulus diameter, mm | 28.9 (2.3) | 28.5 (2.4) | -0.39 | -1.05 to 0.27 | 0.24 |
Sinus of Valsalva maximum diameter, mm | 44.9 (2.9) | 44.5 (3.0) | -0.37 | -1.23 to 0.51 | 0.40 |
Sinus of Valsalva mean diameter, mm | 43.5 (2.4) | 43.2 (3.0) | -0.38 | -1.16 to 0.40 | 0.33 |
Sinus of Valsalva area, cm2 | 16.3 (2.0) | 15.9 (2.4) | -0.42 | -1.05 to 0.21 | 0.18 |
Ascending aorta diameter, mm | 32.4 (3.6) | 32.3 (3.7) | -0.10 | -0.92 to 0.74 | 0.82 |
Ascending aorta area, cm2 | 8.2 (1.7) | 8.4 (1.8) | 0.19 | -0.20 to 0.59 | 0.33 |
Arch diameter, mm | 24.1 (2.0) | 24.5 (2.8) | 0.41 | -0.56 to 1.37 | 0.39 |
Descending aorta diameter, mm | 22.9 (2.4) | 24.2 (3.0) | 1.32 | 0.70 to 1.94 | <0.001 |
Descending aorta area, cm2 | 4.1 (0.9) | 4.4 (1.0) | 0.35 | 0.12 to 0.58 | 0.004 |
There was no increase in the percentage of patients with mild aortic regurgitation (33% [8/24] at baseline), and no patient had an increase in the severity of aortic regurgitation at follow up.
2 female patients each had an uneventful pregnancy after the procedure without any significant changes in their aorta sizes.
Key safety findings
1 patient, whose procedure was described as a technical failure, had intractable hypotension in the recovery ward after the operation and noted to have ST-segment changes in the inferior electrocardiogram leads along with hypokinesia of the right ventricle on the echocardiogram. The chest was urgently reopened, and the seam of the mesh support was opened to release any possible impingement on the coronary arteries. The electrocardiogram changes immediately resolved with haemodynamic stability postoperatively.
Study 5 Treasure T (2012)
Study type | Non-randomised comparative study |
|---|---|
Country | UK |
Recruitment period | 2004 to 2009 |
Study population and number | n=40 (20 PEARS, 20 aortic root replacement) Patients with Marfan syndrome |
Age and sex |
|
Patient selection criteria | All patients in the study would have been candidates for either external support or root replacement. The external root support patients, by protocol, had aortic root diameters of 4 to 5.5 cm and no more than grade 1 (trivial) aortic regurgitation. |
Technique |
|
Follow-up | To hospital discharge |
Conflict of interest/source of funding | Development costs were met by Exstent who manufacture the custom made devices for each patient. Costs per device were partly recovered from NHS purchasing. One author is a shareholder and director of Exstent, which holds the intellectual property rights in the external aortic root support project. He was the originator of the concept and the first recipient of the device. No other author has any pecuniary interests or any other conflict of interests. |
Analysis
Study design issues: Non-randomised retrospective comparative study. The comparison group were selected from patients who were operated on during the same time frame, in other hospitals where external aortic root support was not available. A matched comparison group, of similar age, aortic size and aortic valve function to those having external aortic root support, was constructed by minimisation. The main outcomes were hospital stay, blood loss and blood product usage.
Study population issues: The study includes the first 20 patients to have the PEARS procedure. There was a poor match for sex between the groups. The mean aortic diameter at baseline was 46 mm in the external aortic root support group (range 40 to 54 mm) and 48 mm in the control group (range 38 to 58 mm).
Key efficacy findings
Number of patients analysed: 40 (20 PEARS, 20 aortic root replacement)
Outcome | PEARS | n | Aortic root replacement | n | p |
|---|---|---|---|---|---|
Operation time (min) | 148 (125 to 415) | 20 | 240 (150 to 414) | 19 | Not reported |
Bypass time (min) | 0 (0 to 20) | 20 | 134 (52 to 316) | 20 | Not reported |
Ischaemic time (min) | 0 (0 to 0) | 20 | 114 (41 to 250) | 20 | Not reported |
Postoperative days in hospital | 6 (4 to 16) | 20 | 7 (4 to 17) | 20 | Not significant |
Chest tube drainage up to 4 hours after surgery (ml) | 50 (25 to 400) | 20 | 230 (85 to 735) | 18 | <0.02 |
Chest tube drainage up to 12 hours after surgery (ml) | 120 (25 to 925) | 20 | 385 (200 to 1010) | 18 | <0.02 |
Key safety findings
Transfusion product | PEARS, n=20 | Aortic root replacement, n=18 | p |
|---|---|---|---|
Red cell | 1 (single unit) | 9 (mean 2.0 units per transfused patient) | 0.002 |
Platelet | 0 | 9 (mean 1.6 units per transfused patient) | <0.001 |
Fresh frozen plasma | 0 | 12 (mean 4.8 units per transfused patient) | <0.001 |
5 of the patients who had root replacement were prescribed oral anticoagulants, which will be mandatory for life for those with a mechanical heart valve.
Study 6 Pepper J (2015)
Study type | Case report |
|---|---|
Country | UK |
Recruitment period | 2008 |
Study population and number | n=1 Patient with Marfan syndrome |
Age and sex | 26 year old male |
Patient selection criteria | Not applicable |
Technique | PEARS with a macroporous mesh. |
Follow-up | 4.5 years |
Conflict of interest/source of funding | None declared. |
Key efficacy findings
The patient died 4.5 years after having a PEARS procedure. He was the first patient to die with an implant. At autopsy, there were expected pericardial adhesions but no blood in the pericardium or mediastinum. The aortic arch and descending aorta appeared normal. The external aortic mesh was fully incorporated in the adventitia and could not be separated from it. There was no aortic dissection. There was no impingement on the coronary arteries or their orifices by the external support. The examining pathologist found no reason to suspect that the mesh support had contributed to death. The mesh position was stable and it was fully incorporated by collagen. Examination of the heart confirmed a dilated cardiomyopathy presumed to be related to Marfan syndrome, as was the cause of death in his mother.
The supported aortic root had the histological appearance of a normal aorta. The histological appearance suggested the possibility that the incorporated support of the aortic root allowed recovery of the microstructure of the media.
Study 7 Kockova R (2019) - conference abstract
Study type | Non-randomised comparative study |
|---|---|
Country | Czech Republic |
Recruitment period | 1998 to 2017 |
Study population and number | n=27 (13 PEARS, 14 standard prophylactic aortic root surgery) Patients with Marfan syndrome or non-Marfan genetic aortopathy |
Age and sex | Not reported |
Patient selection criteria | Not reported |
Technique |
|
Follow-up | Not reported |
Conflict of interest/source of funding | Not reported |
Analysis
Study design issues: Retrospective, single centre, non-randomised comparative study. The main aim was to compare the severity of inflammatory response of PEARS against standard prophylactic aortic root surgery.
Study population issues: Patient baseline characteristics were similar in the 2 groups, except aortic root was statistically significantly larger in the standard surgery group than in the PEARS group (60±12 mm compared with 48±5 mm; p=0.003). Most patients in both groups had Marfan syndrome (62% in the PEARS group compared with 79% in the standard surgery group).
Other issues: Study was published as a conference abstract, so there is limited information.
Key safety findings
Postprocedural inflammatory characteristics | PEARS, n=13 | Standard prophylactic aortic root surgery, n=14 | p value |
|---|---|---|---|
Peak level of C-reactive protein (mg/L) | 264.5±84.4 | 184.6±89.6 | 0.034 |
Peak white blood cell count (109/L) | 15.2±3.8 | 11.9±3.3 | 0.029 |
ST elevation, n (%) | 11 (85) | 6 (43) | 0.024 |
Early fever needing hospital readmission, n (%) | 10 (77) | 5 (36) | 0.032 |
Recurrent fever needing hospital readmission, n (%) | 6 (46) | 1 (7) | 0.020 |
Early pericarditis needing hospital readmission, n (%) | 4 (31) | 0 (0) | 0.024 |
Recurrent pericarditis needing hospital readmission, n (%) | 4 (31) | 0 (0) | 0.024 |
All surgical procedures were successful and without major complications.
Study 8 Nemec P (2020)
Study type | Case series |
|---|---|
Country | 9 countries, including UK |
Recruitment period | 2004 to 2020 |
Study population and number | n=317 Patients who had PEARS |
Age and sex | Not reported |
Patient selection criteria | Not reported |
Technique | PEARS (ExoVasc Ltd.) |
Follow-up | 871 patient years |
Conflict of interest/source of funding | None declared. |
Analysis
Study design issues: The main aim of the study was to summarise aspects of the procedure including indications, surgical technique and safety. It includes a brief summary of data held by the manufacturer of the external aortic root support in a prospective database.
Study population issues: The most common indication was Marfan syndrome (57%).
Key efficacy and safety findings
Number of patients analysed: 317
The long-term experience comprises 871 patient/years with 1 patient living for 15 years and 19 patients living for more than 10 years.
Adverse events
Perioperative mortality=0.3% (1/317); the patient had severe pectus excavatum and died 5 days after surgery because of an injury to the left coronary artery. The support was not placed during the surgery.
Injury to the right coronary artery, n=1; successfully resolved with coronary artery bypass grafting.
Reoperation because of hypotension while in the intensive care unit, n=1. The axial suture line of the mesh
implant was partially released. After 6 years, aortic valve regurgitation developed, and the patient had surgery to correct dilation of the non-coronary sinus. The mesh-reinforced aortic wall was identified and could be cut and sewn safely.
One patient died 4.5 years after the procedure from an unrelated cause: the reason was probably malignant arrhythmia. A second patient died 6.5 months after the procedure from chronic heart failure. He had a history of alcoholic cardiomyopathy. Immediately after the external aortic root support procedure, he had acute heart failure because of occlusion of his circumflex artery. It was managed successfully by a reoperation, adjustment of the support and implantation of a stent in the circumflex artery.
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