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The Perceval Sutureless Aortic Valve: Review of Outcomes, Complications, and Future Direction

Powell, Ramsey BEng*; Pelletier, Marc P. MD; Chu, Michael W. A. MD; Bouchard, Denis MD§; Melvin, Kevin N. MD; Adams, Corey MD

Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery: May/June 2017 - Volume 12 - Issue 3 - p 155–173
doi: 10.1097/IMI.0000000000000372
Review Article

Surgical aortic valve replacement with a stented prosthesis has been the standard of care procedure for aortic stenosis. The Perceval (LivaNova, London, United Kingdom) is a sutureless aortic valve bioprosthesis currently implanted in more than 20,000 patients. The purpose of this article was to review the literature available after 9 years of clinical experience of the Perceval aortic valve. PubMED, Embase, and the Cochrane Library databases were searched. A meta-analysis of summary statistics from individual studies was conducted. A total of 333 studies were identified and 84 studies were included. Thirty-day mortality and 5-year survival ranged from 0% to 4.9% and 71.3% to 85.5%, respectively. Compared with stented prosthesis, pooled analysis demonstrated a statistically significant reduction in aortic cross-clamp and cardiopulmonary bypass times (minutes) with Perceval (38.6 vs 63.3 and 61.4 vs 84.9, P < 0.00001, respectively). Compared with transcatheter aortic valve implantation, pooled analysis demonstrated a statistically significant reduction with Perceval in paravalvular leakage (1.26% vs 14.31%) and early mortality (2.3% vs 6.9%). Favorable hemodynamics, acceptable valve durability, and ease of implantation in minimally invasive cases were reported as benefits. A trend toward increased rates of permanent pacemaker implantation and low postoperative platelet count were identified. Special use and off-label procedures described included bicuspid aortic valves, valve-in-valve for homograft and stentless prosthesis failure, concomitant valvular procedures, porcelain aorta, and endocarditis. The Perceval valve has shown safe clinical and hemodynamic outcomes. Outcomes support its continued usage and potential expansion.

Supplemental digital content is available in the text.

From the *Faculty of Medicine, Memorial University of Newfoundland, St. Johns, NL Canada; †Division of Cardiac Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA USA; ‡Division of Cardiac Surgery, Department of Surgery, Western University, London, ON Canada; §Department of Surgery, Montreal Heart Institute, Montreal, PQ Canada; and ∥Division of Cardiac Surgery, Department of Surgery, Memorial University of Newfoundland, St. John's, NL Canada.

Accepted for publication March 25, 2017.

Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s website (www.innovjournal.com).

Corey Adams, MD, acts on behalf of the Canadian Thoracic Aortic Collaborative.

Disclosures: Michael W. A. Chu, MD, is on the speaker's bureau for Medtronic Canada, Brampton, ON Canada, Edwards Lifesciences, Inc, Mississauga, ON Canada, LivaNova, PLC, London, United Kingdom, Symetis SA, Ecublens, Switzerland, and Abbott, Chicago, IL USA. Denis Bouchard, MD, is a proctor for LivaNova, PLC, London, United Kingdom. Ramsey Powell, BEng, Marc P. Pelletier, MD, Kevin N. Melvin, MD, and Corey Adams, MD, declare no conflicts of interest.

Address correspondence and reprint requests to Corey Adams, MD, 300 Prince Philip Dr, St. John's, NL Canada A1B 3V6. E-mail: cadams@munmed.ca.

Surgical aortic valve replacement (SAVR) performed by a median sternotomy has been the surgical standard of care for lesions of the aortic valve (AV).1 Elective SAVR is associated with low mortality and morbidity and results in significant improvement in quality of life.2 Despite such positive outcomes in SAVR up to one third of patients who might benefit from AVR are not suitable surgical candidates because of excess comorbidities and frailty.2,3

Transcatheter AV implantation (TAVI) has shown equivalent results to SAVR for intermediate and high-risk patients4–8 and superior outcomes in inoperable patients when compared with medical therapy.9–11 Current limitations of TAVI include higher rates of permanent pacemaker implantation, vascular complications, concerns over leaflet thrombosis, and paravalvular leakage (PVL).4–8

This changing management for intervention on AV disease toward a less invasive TAVI approach has led to the development of ways of reducing the physiological impact of a SAVR. Sutureless implantation can reduce aortic cross-clamp (CC) and cardiopulmonary bypass (CPB) times and facilitate minimally invasive (MI) SAVR, whereas the lack of a stent enables improved hemodynamics.12–16 The Perceval valve (LivaNova, London, United Kingdom) consists of bovine pericardium leaflets and a self-anchoring, self-expanding and elastic nitinol alloy stent, covered by a thin carbofilm coating for improved biocompatibility.17 For implantation, the valve is collapsed with an atraumatic compression device to ensure that the valve leaflets are not affected.17

The purpose of this article is to review the existing clinical experience of the Perceval valve, including clinical outcomes, postoperative hemodynamics, comparative studies between TAVI and stented AVR, complications, off-label and special access usage, and cost analysis after 9 years of clinical experience.

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METHODS

Inclusion Criteria

Studies were included if any of the following criteria were met: (1) reported clinical outcomes with the Perceval sutureless bioprosthesis; (2) reported outcomes of the Perceval compared with other procedures; (3) reported analysis of complications using the Perceval; (4) reported off-label experience; (5) reported learning curve analysis; (6) reported cost analysis; or (7) reported one or more case of SAVR with the Perceval.

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Exclusion Criteria

Studies were excluded if any of the following criteria were met: (1) reported outcomes of exclusively other sutureless valves; (2) grouped outcomes of the Perceval with other prostheses in the same cohort; (3) reported procedures performed on cadaveric or animal subjects; (4) not published in the English language; (5) not published in a peer-reviewed journal; and (6) was a conference abstract. If there were multiple studies on the same cohort, only the most recent was included.

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Data Extraction

The final search was performed on October 11, 2016. All data were extracted from article texts, tables, and figures. One investigator screened the articles retrieved twice, and the final results were reviewed by all senior investigators. The primary outcomes of each included study were reported.

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Statistical Methods

We conducted a meta-analysis of summary statistics from individual studies included in the systematic review.

Number of events and number of patients at risk for dichotomous outcomes (eg, early mortality), means and standard deviations (SDs) for continuous outcomes (eg, CC time), and survival proportions for time to event outcomes (eg, overall survival) were extracted from each study.

If median, instead of mean, was provided, normality was assumed and median was considered equal to the mean. Similarly, assuming normality, if interquartile range or range were provided, SD was calculated as interquartile range/1.35 and range/4,18 respectively.

For time to event data, the hazard ratio (HR) was calculated from the reported survival proportions, assuming proportionality of hazards. The standard errors for the log(HR) were derived from the reported P values testing differences between proportions, using methods described in Higgins and Green.18

Random effect models were fitted to obtain the pooled estimates of the mean difference for continuous outcomes, the relative risk for dichotomous outcomes, the HR for time to event outcomes, and their corresponding 95% confidence intervals (CIs). Each study estimate was weighted by the inverse of its variance plus the between-study variance component τ2. The moment estimator of τ2 was used.19

The Q test was performed to assess between-study heterogeneity, and the I 2 statistics, which express the percentage of the total observed variability due to heterogeneity, was also calculated.20

The association between continuous variables was evaluated using Pearson correlation coefficient (r).

All statistical analyses were performed using Review Manager 5.3 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration) and SAS 9.3 (SAS Institute, Cary, NC USA).

All reported P values were two-sided.

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RESULTS

A total of 333 studies were identified through database searching and two additional studies were found in the reference lists of those studies (Fig. 1). There were 12 duplicates, and 239 articles were excluded after application of inclusion and exclusion criteria. A total of 89 studies were included. There were no randomized controlled trials, no meta-analyses examining only the Perceval, 17 single-arm studies, 8 studies compared the Perceval with TAVI, 8 studies compared the Perceval with other SAVR, 18 studies examined complications associated with the Perceval, 1 study examined the learning curve of using the Perceval, 2 studies examined off-label usage of the Perceval, two studies performed a cost analysis of the Perceval, and 3 studies have published recommendations for sutureless AVR.

FIGURE 1

FIGURE 1

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Single-Arm Outcomes

Seventeen studies examining outcomes of SAVR with the Perceval without a control group were identified (Table 1). There were two prospective nonrandomized trials, one prospective observational cohort study, 12 retrospective observational cohort studies, and two case series with less than 10 patients.

TABLE 1

TABLE 1

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Short-Term Outcomes

Short-term outcomes were defined as outcomes of 30 days or less. Short-term results were found in 15 studies on nine different cohorts of patients (Table 1). The number of patients ranged from 7 to 658.21,35 Mean ± SD age ranged from 69 ± 11.3 to 82 ± 6 years,28,35 and mean ± SD EuroSCORE ranged from 7.2 ± 8.4% to 13.2 ± 7.3%.23,27 For isolated sutureless AVR in noncase series studies, mean ± SD CC times ranged from 17.8 ± 6.2 to 40.5 ± 11.6 minutes23,26 and mean ± SD CPB times ranged from 46.4 ± 6.7 to 66 ± 23 minutes,22,27 whereas for combined cases, mean ± SD CC time ranged from 44.2 ± 13.3 to 69.6 ± 28.8 minutes23,24 and mean ± SD CPB times ranged from 67.6 ± 32.9 to 88.7 ± 38.4 minutes.23,24 Overall, for isolated and combined cases, mean ± SD CC times ranged from 32.0 ± 14.9 to 50.7 ± 22.8 minutes25,29 and mean ± SD CPB times ranged from 44.7 ± 18.6 to 78.9 ± 32.3 minutes.25,29 Overall, for isolated and combined cases, mean ± SD intensive care unit (ICU) stay ranged from 2 to 3.7 ± 3.9 days,23,26 whereas the total hospital stay ranged from a mean ± SD of 11.4 ± 7.6 to 15 days.23,26

In noncase series studies, 30-day mortality ranged from 0% to 4.9%25,26 and rates of reoperation within 30 days for bleeding and/or valve explantation ranged from 2.5% to 5.0%,22,23 rates of permanent pacemaker implantation ranged from 3.1% to 17%,23,26 and rates of moderate and severe PVL at discharge ranged from 0% to 3.4%.23,24,27 Structural valve deterioration was reported as 0% at 30 days in two studies21,27 with a max follow-up of 2 years.

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Mid- and Long-Term Outcomes

Mid-term outcomes were defined as outcomes occurring between 30 days and 2 years postoperatively. Long-term outcomes were defined as outcomes beyond 2 years. Mid- and long-term follow-up was performed in six cohorts, and outcomes can be found in Table 2. Maximum reported follow-up was 5 years and was found in two cohorts.25,27 One-year survival ranged from 86.4% to 91.7%,21,27 2-year survival ranged from 82.4% to 87%,22,24 and 5-year survival ranged from 71.31% to 85.5%.25,27 At 1 year, rate of reoperation was 4.2% in two studies,22,25 stroke ranged from 0% to 3%,21,26 explantation ranged from 0% to 2.0%,21,26 PVL ranged from 0.6% to 3.85%,21,24 and endocarditis ranged from 0% to 3.33%.25,27 Structural valve deterioration was reported as 0% at mean ± SD of 13.4 ± 11.6 months,2510 ± 20 months,24 and at 1 year21 and 0% in patients who have reached 5-year follow-up.27,36 However, recently, one case report of structural valve deterioration has been published by Bouhout et al.58

TABLE 2

TABLE 2

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Outcomes With Concomitant Procedures

In the only large cohort study of its category, Shrestha et al29 retrospectively examined the outcomes of the Perceval in patients selected for European trials who exclusively underwent concomitant procedures. A total of 243 patients were included, with mean ± SD age of 79.7 ± 5.1 years and mean ± SD EuroSCORE of 9%.29 Of the cases performed, 75% were coronary artery bypass grafting (CABG), 9% were septal myectomy, and 9% were other procedures (tricuspid annuloplasty, atrial ablation, closure of patent foramen ovale, and replacement of ascending aorta).29 Mean ± SD CC and CPB times were 50.7 ± 22.8 and 78.9 ± 32.3 minutes.29 Thirty-day mortality was 2.10%, whereas 6-month, 1-year and 2-year survival rates were 90%, 88%, and 86.4%, respectively.29 At 30 days, rate of reoperation was 6.27% (9 patients for re-exploration for bleeding, 1 with endocarditis, 1 for aortic root bleeding, and 4 for PVL), stroke was 1.3%, explantation was 2.1% (4 patients for PVL and 1 for endocarditis), permanent pacemaker implantation was 5.9%, nonmild PVL was 1.69%, and endocarditis was 0.41%.29 At 2 years, a total of four patients required reoperation (because of endocarditis in all 4).29

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Minimally Invasive Outcomes

Minimally invasive (MI) was defined as a procedure performed through a ministernotomy (MS) or right anterior minithoracotomy. Five studies have reported exclusively on outcomes of MI SAVR with the Perceval without a control group (Table 3), and all were retrospective observational cohort studies.30–34 The number of patients ranged from 35 to 281.30,34 Mean ± SD age ranged from 76.6 ± 7.1 to 80 ± 4 years,32,34 and mean ± SD EuroSCORE I ranged from 8 to 12 ± 9%.30,34 Rates of conversion to full sternotomy ranged from 0% to 1.4%,30,32,34 whereas mean CC time ranged from 34 ± 10 to 59.3 ± 19 minutes32,34 and mean CPB times ranged from 68 ± 18 to 92.3 ± 27 minutes.32,33

TABLE 3

TABLE 3

Thirty-day mortality ranged from 0% to 2.1%31,32,34 and total hospital stay ranged from 7.1 ± 3.1 to 11.6 ± 4.9 days.31,32 At 30 days, reoperation rates ranged from 0% to 5.1%,32,33 stroke rates ranged from 0% to 2.2%,32–34 permanent pacemaker implantation rates ranged from 3.6% to 7.6%,31,32 and PVL ranged from 0% to 1.45%.31–34

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Left Ventricular Mass Regression

Santarpino et al38 examined left ventricular (LV) mass regression in 78 patients who had undergone SAVR with the Perceval. Mean ± SD age was 77.1 ± 5.3 years.38 Mean ± SD left ventricular mass index decreased from 148.4 ± 48.4 g/m2 to 119.7 ± 38.5 g/m2 (P = 0.002) whereas interventricular septum and V posterior wall thickness decreased from 13.9 ± 2.3 mm to 12.1 ± 2.8 mm (P = 0.02) and 12.1 ± 1.6 mm to 11.3 ± 1.3 mm (P = 0.04) at follow-up.38

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Hemodynamics

Postoperative valve hemodynamics after implantation was reported in eight studies (Table 4). Maximum follow-up was 5 years.25,27 At discharge, mean ± SD effective orifice area (EOA) ranged from 1.4 ± 0.4 to 1.56 ± 0.37 cm,23,24 mean ± SD gradient ranged from 10.3 ± 4.5 to 14 ± 6 mm Hg,21,22 and mean ± SD peak gradient ranged from 19.4 ± 8.1 to 27 ± 11 mm Hg21,22 in noncase series studies. At 1 year, mean ± SD EOA ranged from 1.3 to 1.6 ± 0.3 cm25,26 and mean ± SD gradient ranged from 8.7 ± 3.7 to 9.9 ± 4.6 mm Hg.24,27 Of the 10 patients who reached 5-year hemodynamic follow-up results in the Perceval Pilot Trial, mean ± SD EOA was 1.69 ± 0.42 cm2 and mean ± SD gradient was 9.3 ± 5.5 mm Hg.27

TABLE 4

TABLE 4

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Learning Curve

Murzi et al39 examined the effect of the learning process on outcomes in MI SAVR with the Perceval through a right anterior minithoracotomy at a single institution. A total of 300 patients received the Perceval from six different surgeons.39 Patients were chronologically divided into three groups of 100 patients each.39 No significant differences between groups were found.39 Surgeons A, B, and C exhibited a mild learning curve, whereas surgeons D, E, and F did not.39

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Comparative Studies

Conventional Stented Biological Aortic Valves

To date, eight studies have compared the Perceval with conventional prostheses (Table 5).12–16,40–42 There were no randomized control trials, and all studies were retrospective observational cohort studies. The number of patients who received a Perceval ranged from 14 to 204,14,40 and four studies used propensity matching.13–15,40 Maximum follow-up was 2 years. Baseline characteristics were not different between groups in all studies except 1, in which patients who received the Perceval were significantly older and of a higher EuroSCORE risk.16 Overall, CC and CPB times were significantly shorter using the Perceval than conventional valves in all eight studies.12–16,40–42 The pooled analysis of comparative studies confirmed these results demonstrating significant reduction of CC and CPB times with Perceval [38.6 vs 63.3 minutes, odds ratio (OR) = −20.71, 95% CI = −24.81 to −16.60, P < 0.00001 (Fig. 2), and 61.4 vs 84.9 minutes, OR = −22.83, 95% CI = −27.39 to −18.26, P < 0.00001 (Fig. 3), respectively].

TABLE 5

TABLE 5

FIGURE 2

FIGURE 2

FIGURE 3

FIGURE 3

Short-term outcome data are found in Table 6. Intensive care unit stay was significantly shorter (P < 0.05) using the Perceval in three studies.15,16,40 Thirty-day mortality was lower using the Perceval valve in every study; however, this did not reach statistical significance in any study,12–16,40–42 and the pooled analysis also demonstrated a lower incidence for Perceval but not statistically significant [3.39% (23/678) vs 3.91% (40/1022), OR = 0.99, 95% CI = 0.58 to 1.70, P = 0.98 (Fig. 4)]. Permanent pacemaker implantation rates were significantly higher using the Perceval in four studies.12,13,40,41

TABLE 6

TABLE 6

FIGURE 4

FIGURE 4

Dalén et al43 compared the outcomes of MS and full sternotomy approaches in patients who had undergone isolated SAVR. Fifty-six patients from each group were propensity matched.43 There were no significant differences between baseline characteristics.43 In the MS and full sternotomy groups, mean ± SD CC and CPB times were 44 ± 23 versus 44 ± 18 minutes (P = 0.931) and 69 ± 23 versus 74 ± 28 minutes (P = 0.363), ICU and hospital stays were 2.5 ± 2.8 versus 3.3 ± 3.8 (P = 0.155) and 12.5 ± 6.8 versus 13.4 ± 10.9 (P = 0.569), 30-day mortality and 2-year survival rates were 0% versus 3.6% and 92% versus 91% (P = 0.463), and rates of permanent pacemaker implantation and renal failure were 11.0% versus 3.6% (P = 0.178) and 0% versus 3.6%.43 There was no significant difference between rates of reoperation, stroke, or endocarditis.43 In the Perceval group, less blood transfusion of packed blood cells were reported versus Perimount.43 Another study by Dalén et al13 reported 2-year survival rates of 92% and 92% for the Perceval through a MS compared with the Carpentier Edwards Perimount stented valve through a full sternotomy, whereas a study by König et al14 comparing the Perceval with conventional valves reported survival rates of 97.5% and 96.2% (P = 0.646), respectively, at mean ± SD of 13 ± 6-month follow-up.

Santarpino et al44 compared outcomes of patients undergoing MI-isolated SAVR with the Perceval who were 80 years or older to those younger than 80 years.44 Mean age and EuroSCORE were significantly different between groups.44 In the older group versus the younger group, ICU stay, 30-day mortality, and survival at mean 13.9-month follow-up were 1.9 ± 0.8 versus 2.5 ± 1.4 days, 1.5% versus 0%, and 3% versus 1.5%, respectively.44 Permanent pacemaker implantation rates were 1.5% versus 3% (P = 0.68).44

A subgroup analysis by Forcillo et al12 compared perioperative outcomes of the Perceval with stented valves in elderly patients (>79 years) undergoing SAVR with concomitant CABG. Baseline patient characteristics were similar between groups.12 Mean CC and CPB times were significantly shorter in patients receiving the Perceval (53 vs 88 minutes, P < 0.001, and 67 vs 106 minutes, P < 0.001).12 Thirty-day mortality was similar (3% vs 5%, P = 0.602), and there was no significant difference in ICU length of stay or rates of stroke, acute kidney injury, pacemaker implantation, or paravalvular leak (Figs. 5, 6).12

FIGURE 5

FIGURE 5

FIGURE 6

FIGURE 6

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Comparative Studies

Transcatheter Aortic Valve Implantation

To date, eight studies have compared the Perceval with TAVI.40–42,45–49 There were no randomized control trials, one prospective observational cohort study, and seven retrospective observational cohort studies. The number of patients who received a Perceval ranged from 31 to 214,42,45 and seven studies used propensity matching.40,42,45–49 Maximum follow-up was 2 years.41,42,45,48,49

Supplemental Table 7, http://links.lww.com/INNOV/A128, shows population and short-term outcome data for the Perceval compared with TAVI. Baseline patient characteristics were similar between groups except in one study in which mean EuroSCORE was found to be significantly higher in the Perceval group.49 Intensive care unit stay was found to be significantly shorter in TAVI in one study (mean = 2 vs 1 day, P < 0.00145), whereas total hospital stay was found to be shorter in TAVI in two studies (11 vs 7 days, P < 0.001,47 and 8 vs 5.5 days, P < 0.00149). However, pooled analysis demonstrated no statistically difference in ICU stay [1.73 vs 1.54 days, OR = 0.16, 95% CI = −0.67 to 0.99, P = 0.71 (Supplemental Figure 9, http://links.lww.com/INNOV/A132)]; thirty-day mortality was higher in the TAVI group in all eight studies, and pooled analysis confirmed these results demonstrating statistically significant reduction in early mortality with Perceval over TAVI [2.98% (19/636) vs 6.91% (44/636), OR = 0.48, 95% CI = 0.28 to 0.82, P = 0.007 (Fig. 7)]. Rates of nonmild PVL were significantly higher in TAVI in all eight studies,40–42,45–49 and pooled analysis confirmed to be statistically lower with Perceval than TAVI, either early events (<30 days) [0.94% (6/636) vs 10.22% (65/636), OR = 0.13, 95% CI = 0.06 to 0.28, P < 00001 (Fig. 8)] as well as when considering overall events [1.26% (8/636) vs 14.31% (91/636), OR = 0.12, 95% CI = 0.06 to 0.25, P < 00001 (Supplemental Figure 10, http://links.lww.com/INNOV/A133)]. The rate of renal failure was significantly higher in the TAVI group in one study (5.3% vs 11.7%, P = 0.03840). Rate of permanent pacemaker implantation was significantly higher in the TAVI group in one study [9.8% vs 14.7%, P < 0.00140]; pooled analysis favored TAVI, however this was not statistically significant [9.75% (62/636) vs 9.28% (59/636), OR = 1.36, 95% CI = 0.62 to 2.98, P = 0.45 (Supplemental Figure 11, http://links.lww.com/INNOV/A134)] for bleeding or explantation was higher when using the Perceval in one study (4.2% vs 0.0%, P = 0.01345), and vascular complications were more common in TAVI in one study (0% vs 10.40%, P < 0.000146). Stroke rates were similar between groups in all studies40–42,45–49; however, pooled analysis demonstrated lower incidence for Perceval but the difference was not statistically significant [1.57% (10/636) vs 2.83% (18/636), OR = 0.63, 95% CI = 0.29 to 1.36, P = 0.24 (Supplemental Figure 12, http://links.lww.com/INNOV/A135)].

FIGURE 7

FIGURE 7

FIGURE 8

FIGURE 8

One-year survival was higher when using the Perceval; however, this was not significant (94.2% vs 90.6%, P = 0.16,45 and 91.6% vs 78.6%, P = 0.149). Two-year survival rates were higher when using the Perceval in four studies, statistically significant in two studies (91.6% vs 66.2%, P = 0.1,49 90.6% vs 87.3%, P = 0.46,42 97.3% vs 86.5%, P = 0.015,49 94.9% vs 79.5%, P = 0.02840).

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Complications

There have been several publications on complications experienced with the Perceval. These include increased permanent pacemaker implantation, PVL, platelet decrease, and structural valve deterioration.

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Permanent Pacemaker Implantation

Five studies investigated the predicting factors for permanent pacemaker implantation after SAVR with the Perceval, two of which examined the effect of modifying surgical technique on permanent pacemaker implantation.50–54

Vogt et al50 examined the predictors of permanent pacemaker implantation in 258 patients who had undergone SAVR using the Perceval, 27 (10%) of which underwent postoperative permanent pacemaker implantation. Age and the presence of preoperative right bundle branch block (RBBB) were determined to be significantly different between the groups on univariate analysis (80 ± 5 vs 77 ± 5 years, P = 0.009, and 33% vs 4.8%, P < 0.001), whereas only preoperative RBBB was significantly different on multivariate analysis (OR = 11.3, P = 0.0002).50 Another study by van Boxtel et al51 examined 31 patients who had undergone SAVR with the Perceval, four (13.3%) of which received a permanent pacemaker postoperatively. It was found that all patients who had undergone postoperative permanent pacemaker implantation had either pre-existing left bundle branch block (LBBB) (n = 1) or new LBBB (n = 3).51

Bouhout et al52 examined the occurrence of conduction disorders in 102 patients who had undergone SAVR with the Perceval, in the early experience, in patients with a mean ± SD of 79.2 ± 4.8 years. Postoperatively, new-onset AV block occurred in 52% (first-degree AV in 34%, Mobitz II AV block in 2%, and complete AV block in 16%).52 New-onset LBBB and RBBB occurred in 33% and 22% of patients, respectively.52 The rate of in-hospital permanent pacemaker implantation was 23%.52 The authors report that the present cohort represents most patients enrolled in a previously published Canadian multicenter study in which their center showed a significantly higher rate of PPM implantation compared with other centers across the country.52 Independent predictors of new-onset conductive disorder or permanent pacemaker implantation were preoperative RBBB (P = 0.03), small preoperative EOA (P = 0.02), and age younger than 85 years (P = 0.03).52

Toledano et al53 investigated the predictors of permanent pacemaker implantation and effect of modifying surgical technique in 140 patients. The modification in surgical technique involved a more thorough, symmetrical decalcification and higher positioning guiding sutures to the intra-annular level.53 Overall incidence of permanent pacemaker implantation was 12%, whereas incidence in each of the standard technique and modified technique were 21% and 8%, respectively.53 Independent predictors of permanent pacemaker implantation were baseline first-degree atrioventricular block (P < 0.01), left QRS axis deviation (P = 0.03), and standard surgical technique (P = 0.02).53

Yanagawa et al54 examined the effect of a modification in operative technique on permanent pacemaker implantation. In their first cohort of 25 patients with the Perceval, a permanent pacemaker implantation rate of 28% was experienced.54 Upon examination of echocardiographic data, it was found that in patients who received a permanent pacemaker, the sealing collar was situated a significantly greater distance from the aortic annulus (7.3 ± 1.5 vs 4.7 ± 1.0 mm, P = 0.001) than those who did not.54 In the second cohort of 18 patients, the guiding sutures were placed at the nadir of each cusp instead of 2 to 3 mm below.54 The permanent pacemaker implantation rate in the second cohort was 0%.54

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Paravalvular Leakage

Fleissner et al55 reported two patients after Perceval implantation that developed moderate to severe leakage. The first patient presented symptomatically on postoperative day 3, and the other was discovered on routine echocardiography at postoperative day 8. Stent distortion at the noncoronary sinus was found in both cases.55 One patient was reoperated with replacement using a conventional biological valve, and the other patient received interventional balloon dilatation of the bioprosthesis.55 The authors commented on the importance of correct sizing in sutureless AV implantation.55

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Platelet Count

Jiritano et al56 compared rates of thrombocytopenia after SAVR between the Intuity (n = 27) and Perceval (n = 16) sutureless bioprostheses. Baseline patient characteristics were similar.56 No risk factors that may have predisposed to platelet dysfunction were described in either group.56 More red blood cell transfusions were given to the Perceval group as compared with the Intuity (10 vs 7 U, P = 0.012) as well as platelets (4 vs 0 U, P < 0.01).56 Platelet counts at postoperative days 3 and 5 as well as at discharge were significantly lower in the Perceval group (P = 0.004, P < 0.001, P = 0.001).56 Platelet count at discharge for Perceval was 102.18 ± 29.34.56 In addition, mean platelet volume was significantly larger in the Perceval group on postoperative days 1, 3, and 5 (P = 0.04, P = 0.001, P = 0.015), whereas platelet distribution width was significantly larger in the Perceval group on postoperative days 3 and 5 (P = 0.018, P = 0.026).65 Clinical outcomes were similar.56

In an early study (2008) on outcomes of 32 patients who had undergone implantation of the Perceval, Flameng et al26 reported no significant difference in platelet levels immediately postoperatively but a moderate decrease (>100 × 109 total) in platelets 6 to 12 months postoperatively (P < 0.001). Reticulocyte count and serum lactate dehydrogenase were elevated at 6 to 12 months postoperatively (P < 0.001).26

Stanger et al57 compared the maximum postoperative decrease in platelet count between the Perimount Magna (n = 199), sutureless 3 F Enable (n = 3), Freedom SOLO (n = 366), mechanical ATS (n = 199), and Perceval (n = 48). It was found that mechanical, Perimount, and 3 F enable valves resulted in significantly smaller decreases in postoperative platelet counts (44 ± 12%, 50 ± 11%, 53 ± 12%, respectively) compared with the Pericarbon Freedom, Perceval, and SOLO (61 ± 14%, 60 ± 10%, 64 ± 12%, respectively).57 Overall, Sorin valves resulted in a 13% greater drop in platelet counts compared with non-Sorin valves; however, these were associated with a lower need for red blood cell (P < 0.001) or platelet (P = 0.001) transfusions.57

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Structural Valve Deterioration

Bouhout et al58 reported a case of early structural valve deterioration of a Perceval prosthesis. A 54-year-old man with symptomatic AS underwent SAVR with a size extra large Perceval.58 The postoperative course was uneventful, and the patient was discharged on postoperative day 4.58 Two years later, the patient presented with a reoccurrence of symptoms and echocardiography showed immobile leaflets and a mean aortic gradient of 84 mm Hg.58 A redo SAVR was performed.58 Intraoperative examination revealed stiffened leaflets with no tear and no thrombus; however, the prosthesis was tightly embedded.58 Removal of the prosthesis required 52 minutes, followed by implantation of a mechanical prosthesis.58

Votsch et al59 reported valvular thrombosis of the noncoronary leaflet of a medium Perceval valve several months after implantation. The patient had undergone reoperation and implantation of 21-mm Edwards Perimount valve.59 It was suspected that high-dose cortisol therapy after implantation of the Perceval may have contributed to the valve thrombosis.59

In large single-arm studies examining outcomes of the Perceval, no structural valve degeneration has yet been reported at 30 days (658 patients),21 13.4 ± 11.6 months (143 patients),25 and 10 ± 20 months (208 patients).24 In the largest cohort of patients studied to date, combining results of all 3 European trials with a total of more than 700 patients and follow-up up to 5 years, no structural valve deterioration has been reported.36

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Special Use and Off-Label Experience

Small Aortic Roots and Patient-Prosthesis Mismatch

One prospective randomized study, five retrospective cohort studies, and one case study examined Perceval in small aortic roots.

Shrestha et al66 retrospectively compared SAVR with the Perceval (n = 50) with stented AVR (n = 70) in patients with small roots (<22 mm). In the Perceval group compared with the stented AVR group, rates of 30-day mortality and 5-year mortality were similar (0% vs 5.3% and 14% vs 17.4%, respectively), whereas mean EOA was significantly larger in the Perceval group (1.5 ± 0.25 vs 1.3 ± 0.2 cm2, P < 0.001).66 Shalabi et al65 also compared the Perceval (n = 22) with stented AVR (n = 22) in patients with small aortic annulus (<21 mm) in a propensity-matched retrospective cohort study. Mortality and complication rates were similar between groups.65 Postoperative peak transvalvular gradient was significantly lower in the Perceval group (15 ± 7 vs 20 ± 11 mm Hg, P = 0.02), whereas indexed EOA (IEOA) was significantly higher in the Perceval group (1.12 ± 0.2 vs 0.82 ± 0.1 cm2/m2, P = 0.02).65

Ghoneim et al67 compared the results of stented AVR (n = 259), aortic root enlargement (n = 20), stentless SAVR (n = 23), and sutureless AVR (n = 49) in patients with a small aortic annulus (≤21 mm). Patients who received a stentless prosthesis had the lowest postoperative gradient (10.9 ± 6.2 mm Hg, P < 0.001).67

Beckmann et al60 retrospectively compared outcomes of aortic root enlargement (n = 36) with SAVR with the Perceval (n = 92). Postoperative IEOA was lower in patients who received the Perceval (0.83 ± 0.14 vs 0.91 ± 0.2 cm2/m2, P = 0.040), whereas rates of patient-prosthesis mismatch and 30-day mortality were similar.60 One-year and 5-year survival were 92% and 54% for the Perceval and 76% and 76% for aortic root enlargement, respectively.60

Villa et al61 compared outcomes of SAVR in patients receiving the small Perceval (n = 47) with patients receiving the medium and large Perceval (n = 229). No significant differences were found in mortality or complication rates as well as peak pressure and IEOA between the groups.61

Baikoussis et al62 reported SAVR with the Perceval in an achondroplastic dwarf. Preoperative EOA was 0.5 cm2, and after decalcification, the aortic annulus was estimated to be 11 mm.62 A small Perceval valve was implanted successfully, and postoperative course was uneventful.62

Dedeilias et al63 performed a prospective, randomized study comparing outcomes between SAVR with the Perceval (n = 25) and the Sorin Soprano stented valve (n = 25) in patients with an aortic annulus of less than 30 mm. Baseline patient characteristics were similar.63 Mortality rates were similar; however, three patients in the stented group presented with New York Heart Association functional classification (NYHA) class 3 symptoms within 6 months.63 The postoperative EOA of the Perceval group was larger than the stented group (1.5 ± 0.3 vs 1.1 ± 0.5 cm2, P = 0.002).63

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Aortic Regurgitation

Gilmanov et al64 reported a case series of 11 patients who received the Perceval for isolated aortic regurgitation (AR) lesions. Mean EuroSCORE was 15.2, and three patients had a LV ejection fraction of 30% or more.64 A single patient died at postoperative day 24.64 No paravalvular or transvalvular leakage was present at 12-month follow-up.64 They concluded that the Perceval is an acceptable valve selection in this population.

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Bicuspid AV

The first reported implantation of a Perceval in a patient with a bicuspid aortic valve was by Santarpino et al.37 The patient successfully underwent SAVR with a 23-mm Perceval, and subsequent postoperative course was uneventful.37 Nguyen et al68 reported 25 patients with a bicuspid aortic valve using a Perceval. Mean ± SD age was 77.8 ± 5.4 years, whereas mean ± SD EuroSCORE II was 3.4 ± 2.6%.68 Rates of in-hospital mortality, permanent pacemaker implantation, stroke, and PVL were 4%, 20%, 8%, and 0%, respectively.68

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Redo Procedures

Santarpino et al69 compared the outcomes of SAVR with the Perceval (n = 8) with valve-in-valve TAVI (ViV-TAVI) (n = 6) in patients undergoing redo procedures. In the Perceval and ViV-TAVI group, mean ± SD age was 78.8 ± 3 and 80.2 ± 2.3 years, whereas mean ± SD EuroSCORE was 36.4 ± 24.1% and 33.8 ± 13.8%.69 There were no in-hospital deaths, postoperative complication rates were similar, and hemodynamic parameters were similar at follow-up.69

Santarpino et al70 examined the outcomes of 13 patients who had undergone redo SAVR with the Perceval. Mean ± SD age was 75.2 ± 5.6 years, and logistic EuroSCORE was 19.4 ± 10.7%.70 Six patients had previously undergone SAVR, whereas seven patients had previously undergone CABG.70 Intensive care unit stay was 3.3 ± 2.3 days, there were no in-hospital deaths, one patient had a permanent pacemaker implantation, and one patient underwent a transient ischemic attack.70 All patients were alive at a mean of 8.5-month follow-up.70

Christ et al71 reported a case study of an 84-year-old patient who had undergone TAVI 2 years ago with an Edwards SAPIEN XT 23-mm valve and subsequently undergone SAVR with the Perceval. The patient had developed pannus overgrowth of the previously implanted bioprosthesis resulting in a narrowed LV outflow tract (12 mm) and a peak pressure gradient of 74 mm Hg.71 The bioprosthesis and native valve were excised, and the Perceval valve was implanted.71 The postoperative course was uncomplicated.71

Poels et al72 reported a 69-year-old female patient who had undergone TAVI with a 23-mm SAPIEN valve and postprocedure had a mean gradient of 13 mm Hg. Nine months later, the patient presented with progressive dyspnea and syncope.72 Echocardiography revealed AS with a mean gradient of 53 mm Hg and mild AR.72 Intraoperatively, the TAVI prosthesis was found to be severely thrombosed.72 A medium Perceval valve was implanted with a lower gradient of 9 mm Hg and no AR.72 The postoperative course was uneventful.72

Five cases have reported the use of the Perceval in redo SAVR for stentless bioprostheses failure. The first two cases, reported by Lio et al,73 were patients who were originally treated for a type A aortic dissection. The first was a 72-year-old woman who had undergone aortic root and ascending aorta replacement with a number 25 Freestyle root (Medtronic, Inc, Minneapolis, MN USA) and number 30 Dacron graft (Maquet Cardiovascular, La Ciotat, France), and the second was an 83-year-old woman who had undergone implantation of a number 27 Freestyle root and number 26 Dacron InterGard graft.73 A larger Perceval was successfully implanted in both patients.73 Both patients were discharged on postoperative day 9.73

The third case was a patient who had an aortic root and ascending aorta replacement with a 25-mm stentless bioprosthesis (Prima Plus; Edwards Lifesciences, Irvine, CA USA) and a 26-mm Hemashield graft 12 years ago.74 At the time of sutureless AVR, the patient was 78 years old with an LV ejection fraction of 49% and severe AR.74 The bioprosthetic valve leaflets were excised, and the Perceval valve was implanted within the existing bioprosthesis.74 Postoperative course was uneventful, and at 3-month follow-up, the patient was in good condition with NYHA class I.74

The fourth case of redo sutureless AVR with the Perceval for stentless bioprosthesis failure was a patient who had undergone MVR and AVR at the age of 40 years followed by repeat MVR and AVR with aortic root replacement using a size 21-mm Freestyle aortic root at the age of 51 years.75 At the time of sutureless AVR, the patient was 63 years old with root narrowing, LV outflow tract narrowing, and commissural rupture between the left and right coronary leaflets.75 Bioprosthetic leaflets were excised, and a small Perceval valve was implanted.75 The postoperative course was uneventful.75

The fifth case of redo SAVR for stentless bioprosthesis failure was in an 82-year-old patient who had undergone AV and root replacement with the Freedom Solo prosthesis at the age of 72 years.76 The patient experienced blunt chest trauma from being run over by a farm tractor, which manifested as progressive dyspnea.76 Two months after, the incident transesophageal echocardiography revealed a 21-mm annulus with a right coronary leaflet tear causing severe AI.76 Intraoperatively, cusps were removed, and a large Perceval valve was implanted.76 Postoperative course was uneventful, and the patient was discharged on postoperative day 7.76

Three case studies reported on the use of Perceval in redo calcified homograft replacement. The first case was a 71-year-old man who received an aortic homograft 19 years ago.77 The patient had severe AR with a logistic EuroSCORE of 23.9%.77 Intraoperatively, a heavily calcified aortic root and torn right coronary leaflet were found.77 Bioprosthetic leaflets were excised, and a large Perceval valve was implanted.77 The postoperative course was complicated by re-exploration for bleeding, and the patient was discharged on postoperative day 8.77

The second case of Perceval use for homograft failure was a 70-year-old woman with severe AS of an aortic homograft that was implanted 9 years ago.78 Logistic EuroSCORE was 10.77%.78 Valve leaflets were excised, and a medium Perceval valve was implanted.78 The postoperative course was uneventful, and the patient was discharged on postoperative day 8.78

The third case of Perceval use for homograft failure was a 62-year-old man who underwent total root replacement with a 23-mm aortic homograft 12 years ago.78 Intraoperatively, a heavily calcified aortic root and prolapsed noncoronary cusp was found.79 Leaflets were removed, and a 25-mm Perceval valve was implanted.79 Postoperative course was uneventful, and at 6-month follow-up, the patient was classified as NYHA class I.79

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Porcelain Aorta

Perceval implantation has been successful in patients with a porcelain aorta. Santarpino et al80 reported a 72-year-old woman with severe AS (AV area = 0.8 cm2), coronary artery disease, and porcelain aorta. The patient underwent CABG, removal of the ascending aorta, and implantation of a 23-mm Perceval and FlowWeave Bioseal 24-mm prosthesis (Jotec, Hechingen, Germany).80 Postoperative course was uneventful, and the patient was discharged on postoperative day 12.80

Gatti et al81 reported the use of Perceval in four patients with porcelain aorta. All patients were discharged within postoperative day 20 and, at 1 to 6-month, were alive with improvements in symptoms.81

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Concomitant Valvular Procedures

Mazine et al82 reported the use of the Perceval in six patients who had undergone triple-valve surgery. Age ranged from 78 to 85 years, and EuroSCORE II ranged from 12.0% to 52.1%.82 The technique first involved tricuspid valve repair, then aortotomy, followed by AV excision and sizing, followed by MVR, and finally resizing of AV and implantation of Perceval.82 There were no in-hospital mortality, two cases of permanent pacemaker implantation, and two cases of acute kidney injury, and ICU length of stay ranged from 1 to 6 days.82

Minh et al83 reported a case series of 10 patients who had undergone Perceval implantation with concomitant MVR. Median age was 79 years, and median EuroSCORE II was 6.2%.83 Surgical technique involved aortotomy and excision of the native valve, followed by AV sizing; then, MVR was performed, the AV was resized, and finally the Perceval valve was implanted.83 All cases were successfully performed.83 There was no 30-day mortality or PVL, and two patients underwent permanent pacemaker implantation.83 At mean ± SD of 8 ± 4-month follow-up, overall survival was 80% and mean ± SD aortic gradient and EOA had improved to 11.1 ± 4.6 mm Hg and 1.5 ± 0.3 cm.83

Moriggia et al84 reported the use of the Perceval with concomitant MVR in a patient with a small aortic root. A 77-year-old woman (body surface area = 1.44 m2, echocardiographic aortic annulus = 19 mm) presenting with severe AS and severe mitral regurgitation was scheduled for MVR and SAVR.84 Intraoperatively, MVR was performed (25-mm Hancock) followed by aortotomy, removal of the native valve, and annular decalcification.84 Sizing was unsuccessful with the smallest conventional biological valve sizer present (19-mm Mitroflow).84 A small Perceval valve was implanted.84 At 4-month follow-up, echocardiography noted normal mitral and aortic prosthesis function and acceptable gradients.84

Lio et al85 reported the use of the Perceval with concomitant MV repair in a patient with severe aortic root calcification. A 68-year-old man presented with severe AS and moderate to severe mitral regurgitation.85 Mitral annuloplasty was performed using a 32-mm CG Future ring (Medtronic, Inc, Minneapolis, MN USA), and a large Perceval valve was implanted.85 Postoperative course was uneventful.85

Mazine et al86 reported the use of the Perceval with concomitant tricuspid valve repair in a patient who had undergone previous MVR with a 29-mm Carbomedics mechanical prosthesis (LivaNova) 21 years ago. The patient was 75 years old with EuroSCORE II of 19.7%, severe AV stenosis (EOA 0.3 cm2, mean gradient 39 mm Hg), and severe tricuspid regurgitation.86 The patient underwent beating-heart tricuspid annuloplasty with a 30-mm Carpentier Edwards Physio ring (Edwards Lifesciences Corp, Irvine, CA USA) followed by sutureless Perceval.86 The patient underwent an uneventful postoperative course and was discharged on postoperative day 15, with an EOA of 1.9 cm2 and mean aortic gradient of 11.6 mm Hg.86

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Endocarditis

Lio et al87 reported a case series of five patients who had undergone SAVR with the Perceval for prosthetic valve endocarditis. Successful implantation occurred in all patients with one in-hospital death.87 There was one in-hospital death due to septic shock and organ failure.87 At median follow-up of 1 month, no death occurred and freedom from reoperation, relapse, and reinfection was 100%.87

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Endoscopic AV Implantation

Vola et al88 reported the first in-human totally endoscopic Perceval valve implantation. The patient was an 83-year-old woman with a mean EuroSCORE II of 2.72.88 Exposure was provided by four ports in the second, third, and fifth intercostal spaces with fem-fem CPB.88 A medium Perceval valve was implanted with a CC and CPB time of 80 and 166 minutes, respectively.88 At 5-month follow-up, echocardiography was satisfactory.88

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Valve-in-Valve TAVI

Three cases of ViV-TAVI within a Perceval for bioprosthesis failure have been reported. Di Eusanio et al89 reported the case of an 80-year-old woman who presented with severe AS and a history of percutaneous coronary intervention for double-vessel coronary disease. The patient underwent SAVR with a medium Perceval.89 Postoperatively, the only complication was moderate renal insufficiency (creatinine peak = 2.2 mg/dL, preoperative baseline = 0.9 mg/dL).89 Transthoracic echocardiography revealed severe aortic paravalvular regurgitation on postoperative day 5.89 Computed tomography scan revealed that the Perceval had collapsed at the noncoronary sinus.89 Percutaneous ballooning was attempted first, but the stent immediately recollapsed and an Edwards SAPIEN XT 23 mm (Edwards Lifesciences Corp) was successfully deployed.89 The postprocedural course was uneventful.89

Durand et al90 reported a case of a 78-year-old woman in cardiogenic shock with severe acute AR. Three years ago, the patient underwent SAVR with a 21-mm Perceval with concomitant CABG.90 A 23-mm Edwards SAPIEN 3 valve was successfully implanted into the Perceval.90 Postoperative course was uneventful, and at 30-day follow-up, the patient was asymptomatic.90

Landes et al91 reported an 80-year-old woman with severe symptomatic AR who had previously undergone SAVR with a Perceval prosthesis. Computed tomography revealed deformation of the valve, and the patient subsequently underwent ViV-TAVI with a 23-mm Edwards SAPIEN XT.91 The patient was asymptomatic at 6-month follow-up.91

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Economic Analyses

Pollari et al15 compared the cost of SAVR with the Perceval (n = 82) with stented AVR (n = 82) in a propensity-matched cost analysis. Costs were collected from normal ward, ICU, dialysis unit, operating room, anesthesia, cardiac diagnostic therapy, endoscopic diagnostics, radiology, laboratory, other diagnostics, and the three main cost element groups of labor, material, and infrastructure.15 The device cost was not included.15 The Perceval was less expensive in all three categories of operating room, hospital stay and diagnostic, radiology, and laboratory costs resulting in an overall cost of US $14,373 compared with US $19,066 for stented AVR, a total cost difference of 25%.15

Santarpino et al92 compared the cost of SAVR with the Perceval (n = 102) with TAVI (n = 102) in a propensity-matched cost analysis. Preprocedural and postprocedural cost data were collected retrospectively from electronic patient records.92 Costs were collected from normal ward, ICU, dialysis unit, operating room, anesthesia, cardiac diagnostic therapy, endoscopic diagnostics, radiology, laboratory, other diagnostics, and the three main cost element groups of labor, material, and infrastructure.92 When the cost of the device was not included, the total cost was not significantly different between the Perceval and TAVI (US $17,195 ± $12,463 vs US $15,082 ± $6,148, P = 0.217).92 However, when the cost of the device was included, SAVR using the Perceval was 32% less expensive (US $23,907 ± $12,463 vs US $35,009 ± $6,547, P < 0.001).92

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Guidelines and Recommendations

In 2015, an International Valvular Surgery Study Group was formed to assess the current evidence for sutureless AVR.93 At the same time, two additional groups of experts recently published two consensus papers on sutureless and rapid deployment valve in standard approach and in MI approaches.17,94 The first series of recommendations concern sutureless AVR in comparison with stented AVR are found in Supplemental Table 8, http://links.lww.com/INNOV/A129.17 The second series of recommendations concern MI sutureless AVR and are found in Supplemental Table 9, http://links.lww.com/INNOV/A130.94

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DISCUSSION

This systematic review provides a comprehensive critique on the clinical outcomes, hemodynamic performance, and practice patterns of the Perceval sutureless biological valve after 9 years of clinical experience from 2007 to 2016.

In developing a biological AV prosthesis that could be deployed without the need for conventional suture implantation, the hypothesis was that surgical time and trauma could be decreased. Hypothesized benefits of the Perceval included quicker operating time, decreased CPB time, and a potential for overall improved clinical outcome. The results of this review and pooled estimates of current meta-analysis support the hypothesis of a shorter operating, CPB, and aortic cross-clamp times with the Perceval compared with standard biological AV implantation techniques.12–16,40–42 Pooled estimates reported CC and CPB times of 38.6 and 61.4 minutes, respectively, for standard AVR using Perceval, which compared favorably with standard prostheses (63.3 and 84.9 minutes). Ranucci et al95 have previously shown that CC time is an independent predictor of severe cardiovascular morbidity, with an increased risk of 1.4% per 1-minute increase in CC time. This further motivates the use of sutureless aortic bioprostheses that are now proven to reduce CC time.

The case of reduced CC and CPB time is also relevant in combined valvular and coronary artery bypass cases. This seems particularly beneficial in older patients where Forcillo and Strestha have shown some benefits.12,29

The hemodynamics of the Perceval also seems to be favorable. The lack of a sewing cuff and near-stentless design allows for a larger EOA and improved hemodynamic performance. The immediate postoperative gradients reported in single-arm studies are adequate, and at long-term follow-up, they appear stable.21–27 Moreover, the benefits of this design are especially evident in patients with small aortic roots who are at risk for patient-prosthesis mismatch. Implantation of the Perceval has resulted in significantly better hemodynamics than conventional AVR55–58 in patients with small aortic roots, and 1- and 5-year survival rates have been proven significantly higher than aortic root replacement.58

One complication of the Perceval is higher than expected permanent pacemaker implantation rates; the reported range is 3.1% to 23%.23,51 The exact reason for this phenomenon is unclear; however, it seems that implantation technique may have an effect. Two studies have modified surgical technique with the aim of reducing pacemaker implantation rates; through more careful decalcification and by placing the guiding sutures slightly higher in the aortic annulus, the rate of permanent pacemaker implantation was reduced.52,53

A platelet drop after Perceval implantation has been reported in small series.26,61,67 This does not seem to have resulted in any clinically significant adverse events.26,61,67 Recently, thrombocytopenia after SAVR with the Edwards SAPIEN valves was reported as a frequent phenomenon and generally self-limited process.96 The etiology of this phenomenon is, as for any type of AV prosthesis, unknown.

In comparison with conventional stented biological valves, it seems that the Perceval has clinical equipoise. However, the use of the Perceval has shown several potential advantages during MI approaches and in simplifying several procedures such as redo cases for failed aortic prostheses, homograft failure, combined procedures, calcified annuli, small annuli, and cases of patients at prosthesis mismatch risk. In comparative studies, 30-day mortality ranged from 0% to 5.8% for the Perceval and from 0% to 6% for conventional SAVR.12–16,40–42 The mortality results were not significantly different in any study12–16,40–42 despite that Perceval patients were in some studies sicker and older.14,16 Our pooled analysis demonstrated lower incidence of 30-day mortality for Perceval, but this was not statistically significant (3.4% vs 3.9%).

In today's management of AV disease, TAVI continues to evolve as a promising and less invasive alternative to standard surgery. However, there are limitations of TAVI, and the results of SAVR have a long-standing history of excellent outcomes with low mortality and morbidity. The results of our meta-analysis suggest that compared with TAVI, Perceval is associated with a reduction of early mortality (2.98% vs 6.9%), early PVL (0.94% vs 10.22%), and overall PVL (1.3% vs 14.3%). Stroke rates also proved to be lower with Perceval, but the difference was not statistically different (1.57% vs 2.83%). However, it is possible that there is a patient selection bias, which influences these outcomes.

We also identified additional unique benefits of this Perceval in its ability to be used in technically challenging redo cases. A calcified aortic root, which is often the case in structural valve degeneration of either stented or stentless biological valves, can be very technically challenging. Suture placement can be difficult, and often an undersized valve is implanted in an elderly and high-risk patient. Because the Perceval avoids the need for suture placement, procedural complexity and operating times can be greatly reduced in these procedures. Several studies have shown the benefit of this, especially in previously implanted stented valves, stentless bioprosthesis failure, calcified homograft replacement, and porcelain aorta37,68–79; in these situations, sutureless AVR should be strongly considered as an alternative to conventional procedures. This benefit may also be apparent in patients with previous coronary bypass surgery and patent grafts. The ability to quickly implant the Perceval may lower the ischemic time that would be occurring with patent internal mammary grafts during a redo operation.

Perceval was shown to reduce the learning curve for MI techniques. This was demonstrated by Murzi et al39 where the first, second, and third group of 100 patients who underwent SAVR with the Perceval at their institution did not display any significant differences in clinical outcomes. Although the exact time for learning curve may require more study, the premise of sizing and placement of the three guiding sutures at the nadir of each commissure followed by postimplant deployment are concepts that can be learned quickly and are familiar to most surgeons.

The health economics of the Perceval are highly dependent on the health care system in which the procedure is occurring; however, the ability to facilitate MI surgery will enhance its cost-effectiveness. Compared with conventional SAVR, shorter operations and hospital stays have the potential to reduce overall cost, whereas the prostheses used in TAVI are generally more expensive compared with the Perceval.15,92

The Perceval AV bioprosthesis has many proven and theoretical advantages over conventional prostheses; however, a randomized control study has not yet been conducted. This is currently being addressed by the PERSIST study. The PERSIST study, the largest randomized controlled study in cardiac surgery after 30 years, is comparing the Perceval with stented valves and is currently ongoing. If PERSIST results confirm some of the positive outcomes that have been reported, the use of the Perceval may increase in many cardiac surgery centers.

Based on this extensive review of the current Perceval valve, it seems that the Perceval has good clinical outcomes and allows surgeons to simplify SAVR while facilitating MI approaches and helping decrease CPB time. It also has potential benefits in technically challenging aortic surgery cases, favorable freedom from structural valve degeneration, and better hemodynamics in patients with small aortic roots. Altogether, these features are likely to result in the increase of its use as surgeons continuously seek to improve the outcomes of AVR and minimize the surgical approaches for their patients.

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Keywords:

Aortic valve replacement; Sutureless aortic valve prosthesis; Rapid deployment prosthesis; Minimally invasive cardiac surgery; Aortic stenosis

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