Prevalence Of Patient-prosthesis Mismatch Research Articles

Frequency of Aortic Root Enlargement to Prevent PPM Patients Undergone Aortic Valve Replacement in Peshawar Institute of Cardiology

Background: Surgical aortic valve replacement (AVR) remains the gold standard for treating symptomatic aortic valve stenosis, aiming to alleviate left ventricular overload, relieve symptoms, and enhance survival. Aortic root enlargement (ARE) is a technique used alongside AVR to accommodate a properly sized prosthetic valve, particularly in patients with a small aortic annulus, to prevent patient-prosthesis mismatch (PPM) and improve clinical outcomes. Objective: This study aimed to evaluate the outcomes of AVR with or without ARE at the Peshawar Institute of Cardiology, focusing on the procedural efficacy, incidence of PPM, and short-term post-operative outcomes. Methods: A retrospective analysis was conducted on 76 patients who underwent AVR, with or without ARE, from December 2020 to March 2023. Data were collected on demographics, clinical manifestations, etiology, comorbidities, operative details, and post-operative outcomes. Statistical analyses included mean ± SD for quantitative variables and frequencies with percentages for qualitative variables, using SPSS 26.0 for data analysis. Results: The average age of patients was 37.53 ± 15.589 years, with a mean BMI of 24.9125 ± 5.07249. Among the procedures, 48.7% were AVR alone, 11.8% AVR with ARE, 10.5% AVR with coronary artery bypass grafting (CABG), and 28.9% AVR with mitral valve replacement (MVR). The mean bypass time for AVR+ARE was 189.3333 ± 77.83155 minutes, compared to 161.9254 ± 64.08737 minutes for other valvular surgeries. Post-operative hospital stay averaged 5.4444 ± 1.74005 days for AVR+ARE cases, against 6.52 ± 2.003 days for other surgeries. Conclusion: AVR with ARE is a feasible and effective strategy for patients with small aortic annuli, demonstrating satisfactory short-term outcomes and potential to reduce PPM. The study highlights the need for cardiac surgeons to gain proficiency in ARE techniques and calls for further research to evaluate long-term outcomes.

In-hospital outcomes after SAVR or TAVI in patients with severe aortic stenosis

There were no data comparing the in-hospital outcomes after transcatheter aortic valve implantation (TAVI) with those after surgical aortic valve replacement (SAVR) in Japan. Among consecutive patients with severe AS between April 2018 and December 2020 in the CURRENT AS Registry-2, we identified 1714 patients who underwent aortic valve replacement (TAVI group: 1134 patients, and SAVR group: 580 patients). Patients in the TAVI group were much older (84.4 versus 73.6 years, P < 0.001) and more often had comorbidities than those in the SAVR group. In-hospital death rate was numerically lower in the TAVI group than in the SAVR group (0.6% versus 2.2%). After excluding patients with dialysis, in-hospital death rate was very low and comparable in the TAVI and SAVR groups (0.6% versus 0.8%). The rates of major bleeding and new-onset atrial fibrillation during index hospitalization were higher after SAVR than after TAVI (72% versus 20%, and 26% versus 4.6%, respectively), while the rate of pacemaker implantation was higher after TAVI than after SAVR (8.1% versus 2.4%). Regarding the echocardiographic data at discharge, the prevalence of patient-prosthesis mismatch was lower in the TAVI group than in the SAVR group (moderate: 9.0% versus 26%, and severe: 2.6% versus 4.8%). In this real-world data in Japan, TAVI compared with SAVR was chosen in much older patients with more comorbidities with severe AS. In-hospital death rate was numerically lower in the TAVI group than in the SAVR group.

Aortic root widening: "pro et contra".

In patients with a small aortic annulus, the clinical benefits of aortic valve replacement depend on avoidance of patient-prosthesis mismatch as it is associated with reduced overall survival. Aortic root widening or enlargement is a useful technique to implant larger valve prosthesis to prevent patient-prosthesis mismatch. Posterior annular enlargement is the commonest technique used for aortic root enlargement. Consistent enlargement of the aortic root requires more extensive procedures like Manouguian or Konno-Rastan techniques. The patients commonly selected are younger patients with good life expectancy. However, caution is advised in applying this procedure in elderly patients, patients with heavily calcified annulus and when performing concomitant procedures. There is no definitive conclusion on the best material to use for the reconstruction of aortic annulus and aorta in aortic root enlargement procedures.

Valve-in-valve transcatheter aortic valve implantation with fracturing of a failed small surgical aortic bioprosthesis: a case report.

BackgroundFailure of a small surgical aortic bioprosthesis represents a challenging clinical scenario with valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) often resulting in patient-prosthesis mismatch. Bioprosthetic valve fracture (BVF) performed as a part of the ViV TAVI has recently emerged as an alternative approach with certain types of surgical bioprostheses.Case summaryAn 81-year-old woman with a history of three surgical aortic valve procedures presented with heart failure. Aortic bioprosthesis degeneration with severe stenosis and moderate regurgitation was found. The patient was deemed a high-risk surgical candidate and the heart team decided that ViV TAVI was the preferred treatment option. Due to the very small 19 mm stented surgical aortic bioprosthesis Mitroflow 19 mm (Sorin Group, Italy) we decided to perform BVF as a part of ViV TAVI to prevent patient-prosthesis mismatch. Since this was the first BVF procedure in our centre, an ex vivo BVF of the same kind of bioprosthetic valve was performed first. Subsequently, successful BVF with implantation of Evolut R 23 mm (Medtronic, USA) self-expandable transcatheter valve was performed. Excellent haemodynamic result was achieved and no periprocedural complications were present. The patient had an immediate major improvement in clinical status and remains asymptomatic after 6 months.DiscussionBioprosthetic valve fracture together with ViV TAVI is a safe and effective emerging technique for treatment of small surgical aortic bioprosthesis failure. Bioprosthetic valve fracture allows marked oversizing of implanted self-expandable transcatheter aortic valves, leading to excellent haemodynamic and clinical results. An ex vivo BVF can serve as an important preparatory step when introducing the new method.

Aortic root enlargement: When and how.

Aortic valve replacement is the definitive management for severe aortic stenosis. Intraoperatively, an aortic root enlargement (ARE) may be used to facilitate the implementation of a suitably sized prosthetic valve. This is to prevent patient prosthesis mismatch (PPM), a condition that causes a left ventricular outflow obstruction. There are four main techniques that are used to perform ARE, namely, Nicks, Manouguian, Nunez (modified Manouguian), and Kanno-Rastan procedures. They each involve incisions through different anatomical structures and allow a variety of valve sizes to be implanted. Studies prove that ARE effectively reduces the incidence of PPM. In addition, they show that there is no definitive link between ARE and perioperative mortality or other complications. There is a scarcity of literature exploring the comparative outcomes of each surgical technique. Therefore, further research is warranted for these procedures to be compared adequately. This review aims to summarise the available literature surrounding ARE with respect to three main questions. (1) What are the indications for ARE, (2) what surgical techniques exist to facilitate ARE, and (3) are there significant differences in patient outcomes when these surgical techniques are employed?

Invited Commentary

Invited Commentary

The Prevalence of Patient-Prosthesis Mismatch Can Be Reduced Using the Trifecta Aortic Prosthesis

Some important studies have shown that patient-prosthesis mismatch is a frequent occurrence after surgical aortic valve replacement that impairs survival. The Trifecta valve (St. Jude Medical Inc, St. Paul, MN) has special architecture designed to achieve the best hemodynamic profile. The aim of this study was to determine the prevalence of mismatch when using this prosthesis. This study included 1,302 patients at 3 months postoperatively, 339 patients with a Trifecta prosthesis and 963 patients (the control group) with a Mitroflow aortic valve (Sorin Group Inc, Mitroflow Division, Vancouver, Canada). Multinomial multivariate logistic regression was calculated to estimate the association between the Trifecta prosthesis and moderate or severe patient-prosthesis mismatch. Any degree of mismatch was present in 5.9% of the Trifecta group and in 42.4% in the Mitroflow group. Moderate patient-prosthesis mismatch was present in 3.8% of the patients with a Trifecta valve and in 32.6% in the Mitroflow group. Severe mismatch was present in 2.1% of the patients with a Trifecta prosthesis and in 9.8% of the patients with a Mitroflow valve. All differences were statistically significant (p < 0.001). The odds ratio of the Trifecta prosthesis as protector against mismatch was 16.9 (95% confidence interval, 9.5 to 30.4) and 11.9 (95% confidence interval, 5.3 to 26.7) for moderate or severe mismatch, respectively. The prevalence of patient-prosthesis mismatch using the Trifecta aortic prosthesis is extraordinary low. This finding may have great clinical repercussions in patients undergoing surgical aortic valve replacement.

Stent valve implantation in conventional redo aortic valve surgery to prevent patient–prosthesis mismatch

The goal was to show the technical details, feasibility and clinical results of balloon-expandable stent valve implantation in the aortic position during conventional redo open-heart surgery in selected obese patients with a small aortic prosthesis and severe patient-prosthesis mismatch. Two symptomatic overweight patients (body mass index of 31 and 38), each with a small aortic prosthesis (a 4-year-old, 21-mm Hancock II biological valve and a 29-year-old, 23-mm Duromedic mechanical valve), increased transvalvular gradients (59/31 and 74/44 mmHg) and a reduced indexed effective orifice area (0.50 and 0.43 cm 2 /m 2 ) underwent implantation of two 26-mm balloon-expandable Sapien 3 valves during standard on-pump redo valve surgery. Using full re-sternotomy, cardiopulmonary bypass and cardioplegic arrest, the two balloon-expandable stent valves were implanted under direct view using a standard aortotomy, after prosthesis removal and without annulus enlargement. Aortic cross-clamp times were 162 and 126 min; cardiopulmonary bypass times were 178 and 180 min; total surgical times were 360 and 318 min. At discharge, echocardiograms showed transvalvular peak and mean gradients of 13/9 and 23/13 mmHg and indexed effective orifice areas of 0.64 and 1.08 cm 2 /m 2 . The 3-month echocardiographic follow-up showed transvalvular peak and mean gradients of 18/9 and 19/11 mmHg and indexed effective orifice areas of 0.78 cm 2 /m 2 and 0.84 cm 2 /m 2 , with improved symptoms (New York Heart Association class 1). Implantation of a balloon-expandable stent valve during redo aortic valve surgery is feasible in selected cases and prevents patient-prosthesis mismatch in obese patients without need for aortic annulus enlargement. Moreover, in the case of stent valve degeneration, this approach permits additional valve-in-valve procedures with large stent valves and prevents re-redo surgery.

Invited Commentary

Rapid deployment and sutureless valves are being implanted with increasing frequency—particularly in Europe—but specific patient populations for these devices remain to be defined. Theron and colleagues [1Theron A. Gariboldi V. Grisoli D. et al.Rapid deployment of aortic bioprosthesis in elderly patients with small aortic annulus.Ann Thorac Surg. 2016; 101: 1434-1442Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar] have focused on the use of rapid deployment valves in a clinically important subgroup of patients in this issue of The Annals, namely, elderly patients with a small aortic annulus. Severe aortic stenosis is often accompanied by fibrosis and calcification of the aortic root in elderly patients, resulting in an inability to insert an adequately sized prosthesis. Simple implantation of a hemodynamically superior valve would be preferable to annular enlargement procedures in elderly patients. Aortic annular enlargement is associated with prolonged aortic cross-clamp and cardiopulmonary bypass times [2Kulik A. Al-Saigh M. Chan V. et al.Enlargement of the small aortic root during aortic valve replacement: is there a benefit?.Ann Thorac Surg. 2008; 85: 94-100Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar] and can be particularly challenging in patients with a calcified aortic root. Previous studies have demonstrated excellent hemodynamic performance for rapid deployment and sutureless valves [3Folliguet T.A. Laborde F. Zannis K. et al.Sutureless Perceval aortic valve replacement: results of two European centers.Ann Thorac Surg. 2012; 93: 1483-1488Abstract Full Text Full Text PDF PubMed Scopus (173) Google Scholar, 4Borger M.A. Moustafine V. Conradi L. et al.A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement.Ann Thorac Surg. 2015; 99: 17-25Abstract Full Text Full Text PDF PubMed Scopus (150) Google Scholar]. Furthermore, a recent randomized clinical trial demonstrated significant reductions in early transvalvular gradients and prevalence of patient-prosthesis mismatch—despite a relatively small sample size—in patients receiving a rapid deployment valve compared with similarly sized conventional bioprostheses [4Borger M.A. Moustafine V. Conradi L. et al.A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement.Ann Thorac Surg. 2015; 99: 17-25Abstract Full Text Full Text PDF PubMed Scopus (150) Google Scholar]. The hemodynamic benefits of these devices, combined with their rapid implantation times and subsequent reduction in myocardial ischemia [3Folliguet T.A. Laborde F. Zannis K. et al.Sutureless Perceval aortic valve replacement: results of two European centers.Ann Thorac Surg. 2012; 93: 1483-1488Abstract Full Text Full Text PDF PubMed Scopus (173) Google Scholar, 4Borger M.A. Moustafine V. Conradi L. et al.A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement.Ann Thorac Surg. 2015; 99: 17-25Abstract Full Text Full Text PDF PubMed Scopus (150) Google Scholar, 5Schlomicher M. Haldenwang P.L. Moustafine V. Bechtel M. Strauch J.T. Minimal access rapid deployment aortic valve replacement: initial single-center experience and 12-month outcomes.J Thorac Cardiovasc Surg. 2015; 149: 434-440Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar], may make them an ideal option in elderly patients with a small aortic annulus. In addition, rapid deployment valves appear to facilitate minimally invasive operations. Minimally invasive rapid deployment valve implantation may represent an effective and financially attractive alternative to transcatheter aortic valve replacement procedures in medium-risk elderly patients. One may expect lower paravalvular leak rates and possibly decreased pacemaker implantation requirements compared with transcatheter aortic valve replacement. Results of two large, nearly completed U.S. Food and Drug Administration approval trials will hopefully shed more light on the use of these devices in elderly patients with small aortic annuli and whether they represent a good alternative to transcatheter aortic valve replacement in this patient population. Rapid Deployment of Aortic Bioprosthesis in Elderly Patients With Small Aortic AnnulusThe Annals of Thoracic SurgeryVol. 101Issue 4PreviewAortic valve replacement in elderly patients with a small aortic annulus remains challenging. Patient–prosthesis mismatch (PPM) should be prevented without impacting operative mortality. Hemodynamic benefits resulting from rapid-deployment aortic valve replacement with the Edwards Intuity bioprosthesis for this indication were evaluated. Full-Text PDF

Aortic Root Enlargement in Octogenarian Patients Results in Less Patient Prosthesis Mismatch

Aortic root enlargement has not been well studied as a modality to prevent patient prosthesis mismatch in octogenarian patients with a small aortic root. We reviewed the records of 117 octogenarian patients who received surgical aortic valve replacement (AVR) between 1993 and 2010. From this group, 87 patients received a 19-mm AVR (small aortic valve, SAV group) and 30 received an aortic root enlargement and a 21-mm AVR (aortic root enlargement, ARE group). The median age of the patients was 84 years (range, 80 to 93) and there were 111 women (95%). Aortic cross-clamp time was 50 minutes (26 to 116) in the SAV group and 67 (26 to 136) in the ARE group (p=0.02). There were no differences in the operative morbidity or morality rates between the groups. Postoperative aortic valve area index was 0.77 cm2/m2 (0.25 to 1.47) in the SAV group and 1.06 (0.51 to 1.94) in the ARE group (p<0.001). Severe patient prosthesis mismatch occurred in 23 patients (32%) in the SAV group in comparison with 3 (12%) in the ARE group (p=0.04). There were no differences in the mid-term outcomes of New York Heart Association functional class (p=0.230) or survival between patients with or without mismatch (p=0.84). Aortic root enlargement in octogenarian patients allows for insertion of larger aortic valve prostheses without any apparent increase in operative morbidity or mortality. The larger prostheses demonstrate better hemodynamic performance and less patient prosthesis mismatch, but no apparent functional or survival advantage.

Circulation : Cardiovascular Imaging

<i>Circulation</i> : <i>Cardiovascular Imaging</i>

Stability of aortic annulus enlargement during aortic valve replacement using a bovine pericardial patch: An 18-year clinical, echocardiographic, and angio–computed tomographic follow-up

Enlargement of the aortic annulus may be required during aortic valve replacement to avoid patient-prosthesis mismatch. We reviewed patients with enlargement of the aortic annulus with the aim of assessing the stability of the procedure by means of echocardiographic and angio-computed tomography studies. A series of 53 consecutive patients underwent aortic valve replacement and enlargement of the aortic annulus from 1994 to 2012. The mean age was 68±11 years (range, 29-84 years), and 85% (45 patients) were female. The predominant valvular lesion was aortic stenosis. The mean logistic European System for Cardiac Operative Risk Evaluation was 11.2±13.0. Enlargement of the aortic annulus was performed by extending the aortotomy incision to separate the commissure between the left and noncoronary sinuses into the anterior mitral leaflet and closing the resulting defect with an adequately tailored patch of bovine pericardium. Hospital mortality was 2%, with 20 late deaths mostly due to noncardiac causes. At a maximum follow-up of 18 years (mean, 8.9±5.0 years), actuarial survival is 37%±9%. No cases of severe patient-prosthesis mismatch were observed, and only 2 patients had moderate patient-prosthesis mismatch. At discharge, the mean aortic root diameter was 30.0±2.3 mm and the mean diameter at the sinotubular junction was 31.5±5.0 mm. At follow-up, the mean aortic root diameter was 31.0±3.4 mm and the mean diameter at the sinotubular junction was 31.7±4.5 mm (P=not significant) with no cases of late aneurysm formation on angio-computed tomography. Enlargement of the aortic annulus is a safe and effective procedure and should be indicated in patients with a small aortic annulus; particularly, it should be considered to prevent patient-prosthesis mismatch and its potential deleterious long-term effects.

Stentless aortic bioprostheses: their role in the treatment of aortic endocarditis should not be underestimated

We read with great interest the comprehensive review article of Funder [1] on the clinical and experimental data surrounding the use of stentless aortic bioprostheses and fully agree with his conclusions. There is no doubt that they are ideal substitutes in patients with small aortic roots to prevent patient–prosthesis mismatch. In this context, they should be implanted in a ‘fullroot’ type of technique to minimize the postoperative aortic regurgitation that may occur due to distortion of the prosthesis [2] and to facilitate both prosthesis over-sizing and the optimization of haemodynamic results [3]. However, we were surprised that Funder did not comment on the value of stentless valves in the context of aortic endocarditis, particularly in patients with root abscesses and prosthetic valve endocarditis. Homografts have been the gold-standard for valve and root replacement in aortic endocarditis for a long time. Although they result in excellent haemodynamics and a low incidence of re-infection after surgery, the need for homograftrelated reoperation should not be underestimated and has been reported to be around 20% at 2 years, most often due to aortic regurgitation [4]. In addition, in these patients, for whom surgery is most often urgent, availability is limited, leading to delay in treatment. In 2003, Siniawski et al. [5] reported on their results using stentless bioprostheses in the setting of complex aortic endocarditis and made a comparison with their experience using homografts. Early mortality, freedom from re-infection and postoperative haemodynamics were not different between the two groups. However, they saw additional benefits of the stentless prosthesis, in that the surgery itself has a more standardized and therefore possibly easier technique. Moreover, limited availability, which may result in delayed surgery using homografts, is not an issue with stentless bioprostheses. If stentless valves are equivalent early after surgery, the question remains of how they compare with homografts in the longer term? Yacoub et al. [6] recently reported the outcomes of a prospective randomized trial including aortic root replacement using Freestyle stentless bioprostheses (Medtronic Inc., Minneapolis, MN, USA) and homografts. Over a median followup of 7.6 years, a significantly higher freedom from valve dysfunction in the stentless group (86 vs 37%) was noted. Consequently, reoperations due to structural valve degeneration were more common after homograft implantation (0 vs 10%). We conclude therefore, that the early outcome of stentless bioprostheses is comparable with homografts in patients suffering from aortic valve endocarditis. As long-term durability and freedom from reoperation are improved using stentless bioprostheses, and because their availability is not restricted, they are ideal substitutes, particularly in patients with complex aortic valve endocarditis.

Sutureless aortic valve replacement to prevent patient–prosthesis mismatch in the era of valve-in-valve implantation

Sutureless aortic valve replacement to prevent patient–prosthesis mismatch in the era of valve-in-valve implantation

Aortic root enlargement in patients undergoing double valve replacement for rheumatic etiology–preliminary results

Introduction Combined aortic and mitral valve disease is usually of rheumatic origin. In these patients we often encounter problem of small valve annuli particularly with aortic annulus. It is still debated whether a small prosthesis should be used or aortic root should be enlarged to prevent Patient Prosthesis Mismatch (PPM). This study was undertaken to review our strategy and feasibility of Aortic Root Enlargement (ARE) in patient undergo Double Valve Replacement (DVR) to avoid mismatch without increase in cost of treatment, morbidity or mortality.

Does the Use of Stentless Aortic Valves in a Subcoronary Position Prevent Patient-Prosthesis Mismatch for Small Aortic Annulus?

Freestyle stentless bioprostheses have shown excellent hemodynamic performance. However, small size subcoronary implants have yet to prove their clinical usefulness. The aim of this study was to determine the incidence of patient-prosthesis mismatch [PPM = Indexed Effective Orifice Area (iEOA) < or = 0.85 cm2/m2] after aortic valve replacement (AVR) with 19-mm and 21-mm stentless bioprostheses and to evaluate clinical and hemodynamic outcomes. From January 1993 to December 2000, 419 patients who had undergone Freestyle bioprostheses implantation were prospectively followed. Sixty-eight patients (16%) received a 19-21-mm prosthesis. The EOA was calculated and indexed to the patient's body surface area to obtain the iEOA. Clinical as well as echographic measures were recorded at discharge and at one and five years. PPM was present in 91% and 80% of patients with 19-mm and 21-mm prostheses, respectively. Severe mismatch (iEOA < or = 0.65 cm2/m2) was present in 58% and 17%. Mean gradients at discharge were 22 +/- 11 mmHg for the 19-mm prostheses and 14 +/- 7 mmHg for the 21-mm prostheses. Perioperative mortality was 33% (4/12 pts) for 19-mm prosthesis and 7% (4/56 pts) for 21-mm prostheses. Five-year actuarial survival was 58% for patients with 19-mm prosthesis and 82% for patients with 21-mm prosthesis (p = 0.04). AVR with small size Freestyle subcoronary implants is associated with a high incidence of PPM and high mortality.

Patient–prosthesis mismatch may be irrelevant after aortic valve replacement with the 19-mm Perimount pericardial bioprosthesis in patients aged 65 years or older

The prevalence of patient-prosthesis mismatch (PPM) and its influence on clinical midterm results were examined in elderly patients whose activity was supposed to be less than that of younger patients. We evaluated valve function and the effects of PPM on the midterm results of the 19-mm Carpentier-Edwards Perimount (CEP) pericardial aortic valve in patients aged 65 years or older. Between August 1996 and May 2005, 51 patients underwent aortic valve replacement with the 19-mm CEP valve. The mean follow-up was 2.4 +/- 1.8 years, involving a total of 134.4 patient-years. The mean age and body surface area at operation were 74.0 +/- 5.0 years and 1.41 +/- 0.14 m(2). There were two (3.9%) operative deaths. Three patients (5.9%) underwent enlargement of their small aortic annuli. The actuarial survival rate at 8 years, including operative mortality, averaged 90.2% +/- 4.7%. The freedom from thromboembolism, reoperation, and valve-related mortality averaged 75.0% +/- 21.7%, 97.8% +/- 2.2%, and 95.3% +/- 3.2%, respectively, at 8 years. High preoperative peak and mean transvalvular pressure gradients were significantly improved after the operation (peak, 93 +/- 35 versus 28 +/- 12 mmHg; mean, 58 +/- 19 versus 17 +/- 7 mmHg, respectively; P < 0.01). The mean left ventricular mass index was reduced from 192 +/- 44 to 142 +/- 46 g/m(2) at late follow-up (P < 0.01). The prevalence of PPM was low (17.6%) when an indexed effective orifice area of less than 0.85 cm(2)/m(2) was taken as the definition of PPM. The clinical results, postoperative pressure gradients, and reduction in left ventricular mass index were not different between the PPM and no-PPM groups. The 19-mm CEP valve produced satisfactory midterm clinical outcomes in patients aged 65 years or older whose activity was supposed to be less than that of younger patients, regardless of the presence or absence of PPM. Moderate PPM was rare and it did not adversely impact on the midterm results. The application of annulus enlargement could be limited to the small number of patients for whom the 19-mm CEP valves are not able to be inserted.