Impact of prosthesis-patient mismatch on 1-year outcomes after transcatheter aortic valve implantation: meta-analysis of 71, 106 patients

Abstract Objectives: This study sought to evaluate the impact of prosthesis-patient mismatch (PPM) on the risk of early-term mortality after transcatheter aortic valve implantation (TAVI). Methods: Databases (Medical Literature Analysis and Retrieval System Online [MEDLINE], Excerpta Medica dataBASE [EMBASE], Cochrane Controlled Trials Register [CENTRAL/CCTR], ClinicalTrials.gov, Scientific Electronic Library Online [SciELO], Latin American and Caribbean Literature on Health Sciences [LILACS], and Google Scholar) were searched for studies published until February 2019. PPM after TAVI was defined as moderate if the indexed effective orifice area (iEOA) was between 0.85 cm2/m2 and 0.65 cm2/m2 and as severe if iEOA ≤ 0.65 cm2/m2. Results: The search yielded 1,092 studies for inclusion. Of these, 18 articles were analyzed, and their data extracted. The total number of patients included who underwent TAVI was 71,106. The incidence of PPM after TAVI was 36.3% (25,846 with PPM and 45,260 without PPM). One-year mortality was not increased in patients with any PPM (odds ratio [OR] 1.021, 95% confidence interval [CI] 0.979-1.065, P=0.338) neither in those with moderate PPM (OR 0.980, 95% CI 0.933-1.029, P=0.423). Severe PPM was separately associated with high risk (OR 1.109, 95% CI 1.041-1.181, P=0.001). Conclusion: The presence of severe PPM after TAVI increased early-term mortality. Although moderate PPM seemed harmless, the findings of this study cannot not rule out the possibility of it being detrimental, since there are other registries that did not address this issue yet.

Prosthesis-patient mismatch negatively affects outcomes after mitral valve replacement: meta-analysis of 10, 239 patients

Abstract Objective: This study sought to evaluate the impact of prosthesis-patient mismatch on the risk of perioperative and long-term mortality after mitral valve replacement. Methods: Databases were researched for studies published until December 2018. Main outcomes of interest were perioperative and 10-year mortality and echocardiographic parameters. Results: The research yielded 2,985 studies for inclusion. Of these, 16 articles were analyzed, and their data extracted. The total number of patients included was 10,239, who underwent mitral valve replacement. The incidence of prosthesis-patient mismatch after mitral valve replacement was 53.7% (5,499 with prosthesis-patient mismatch and 4,740 without prosthesis-patient mismatch). Perioperative (OR 1.519; 95%CI 1.194-1.931, P<0.001) and 10-year (OR 1.515; 95%CI 1.280-1.795, P<0.001) mortality was increased in patients with prosthesis-patient mismatch. Patients with prosthesis-patient mismatch after mitral valve replacement had higher systolic pulmonary artery pressure and transprosthethic gradient and lower indexed effective orifice area and left ventricle ejection fraction. Conclusion: Prosthesis-patient mismatch increases perioperative and long-term mortality. Prosthesis-patient mismatch is also associated with pulmonary hypertension and depressed left ventricle systolic function. The findings of this study support the implementation of surgical strategies to prevent prosthesis-patient mismatch in order to decrease mortality rates.

Desproporción prótesis-paciente luego de reemplazo de válvula aórtica y seguimiento a 6 años / Patient-prosthesis mismatch in aortic valve replacement: a 6 year follow up

Resumen: Introducción: La desproporción prótesis-paciente (DPP) tras cirugía valvular ocurre cuando el área efectiva de orificio protésico (AEO) es fisiológicamente demasiado pequeño en relación con el tamaño del paciente, lo que resulta en gradientes postoperatorios elevados. Material y métodos: Se realizó un estudio observacional retrospectivo. Se analizaron pacientes con estenosis aórtica sometidos a reemplazo de válvula aórtica durante el año 2010. Se calculó AEO/ASC postoperatorio, si AEO/ASC fue menor de 0,85 cm2/ m2 el paciente fue clasificado como desproporción prótesis-paciente. Los eventos clínicos analizados fueron: mortalidad por cualquier causa, recambio valvular, internación por insuficiencia cardiaca y la capacidad funcional al momento de la encuesta. Se realizaron estadísticas descriptivas para analizar las características de la población. Las variables categóricas se expresaron en porcentaje y las variables continuas en promedio y desviación estándar. El análisis estadístico se realizó con el software IBM® SPSS® 19. Resultados: Se analizaron 26 pacientes sometidos a reemplazo de válvula aórtica con un seguimiento a 6 años, 13 de ellos presentaron DPP y mayor porcentaje de disnea, internación por insuficiencia cardiaca y muerte por cualquier causa. La combinación de eventos clínicos en este grupo de pacientes fue del 53,9%. Conclusión: Se observó un mayor número de eventos cardiovasculares en aquellos pacientes que con des- proporción prótesis-paciente.

Abstract: Background: Prosthesis-patient mismatch (PPM) after aortic valve replacement is related to inferior long-term outcomes. The study aim was to describe the rate of cardiovascular events in patients with or without PPM. Methods: The study was based on a retrospective analysis of information obtained from the electronic medical record. All patients undergoing aortic valve replacement, with or without revascularization surgery during 2010 were included. The effective orifice area (EOA) of the prothesis was obtained based on prosthetic valve data from echocardiography recommendations, was related to body surface area (BSA). PPM was diagnosed when EOA / BSA was < 0.85 cm2/m2. Clinical results were evaluated in January 2017 through our electronic medical record data base and a telephone interview. Helsinki criteria for clinical research were respected. Results: 26 patients were analyzed (20 males) with mean age 64 (SD 11.5) years old. A mechanical prosthesis was implanted in 10 patients and a biological one in the remaining subjects. 13 patients had DPP (EOA/BSA 0.77 ± 0.06). At a mean follow up period of 2190 days 44% were in functional class (NYHA) II-III, 31% had been re-hospitalized for heart failure and 8% had died from cardiac causes (overall death rate 31%). The combined outcome rate (overall death, hospitalization for heart failure or re-replacement of the valve) was 54%. Among the 13 patients without PPM, 31% were in functional class II-III, there were no hospitalizations for heart failure and only 4 patients had died from cardiac causes. Combined outcome rate was 23%. Conclusions: PPM was a marker of poorer clinical results on a long term follow up of patients undergoing aortic valve replacement. Inferential statistical analysis was not performed due to the relatively low number of patients included.

Incidence of prosthesis-patient mismatch and early postoperative outcome in elderly patients undergoing aortic valve replacement / 中国胸心血管外科临床杂志

@#Objective    To analyze the incidence of valve prosthesis-patient mismatch (PPM) and ventricular remodeling of elderly patients after aortic valve replacement (AVR). Methods    We retrospectively analyzed the clinical data of 134 patient aged over 65 years who underwent AVR for the aortic stenosis or regurgitation at our hospital between January 2016 and December 2016. There were 73 males and 61 females aged 69.7±3.6 years ranging from 65-79 years. The clinical and ultrasound cardiography data were evaluated. PPM was defined as an effective orifice area index (EOAI) of ≤ 0.85 cm2/m2. The incidence of PPM and the left ventricular remodeling after surgical AVR in the patients with aortic stenosis and aortic regurgitation was analyzed, and the outcomes of aortic valve mechanical prosthesis and aortic valve bioprosthesis were compared. Results    The incidence of PPM was 32.5% in aortic stenosis and 13.0% in aortic regurgitation (P<0.05). One patient died in the early post-operation, and the incidence of severe PPM was 6.0%. Conclusion    The incidence of PPM after AVR in the patients with aortic regurgitation is less than that in the patients with aortic stenosis.

Continuous Suture Technique for Aortic Valve Replacement in Patients with Severe Aortic Valve Stenosis / 日本心臓血管外科学会雑誌

<b>Objective</b> : The aim of the present study is to show the continuous suture technique in which the aortic valve replacement can be safely performed to insert prosthetic valves of an appropriate size in patients with aortic stenosis associated with a small annulus. <b>Patients and Methods</b> : Thirteen patients with severe aortic valve stenosis (aortic valve area <1.0 cm²) underwent aortic valve replacement with the continuous suture technique using three 2/0 non-absorbable monofilament polypropylene sutures. Transthoracic echocardiogram was performed before and after surgery in all patients to determine how large a prosthetic valve could be used compared to the preoperative annular size. <b>Results</b> : The mean size of the prosthetic valve implanted was 23.3 mm, while the preoperative mean value of aortic annulus was 21.7 mm. The 19 mm size prosthetic valves were never used even when the preoperative aortic annular diameter was less than 19 mm (in 2 patients). The duration of procedure time was adequate and the post-operative echocardiography showed excellent results with good prosthetic valve function and no adverse events. <b>Conclusions</b> : Using our continuous suture technique, prosthetic valves of an appropriate size can be safely and effectively inserted at an aortic position in patients with severe aortic stenosis.

Prevention of prosthesis-patient mismatch during aortic valve replacement / 中华胸心血管外科杂志

Objective The prosthesis used for aortic valve replacement (AVR) can be too small in relation to body size,thus causing valve prosthesis-patient mismatch (PPM).The aim of this article was to summarize the preventive strategy of PPM during AVR.Methods A total of 357 patients [203 males,154 females; mean age (54.9 ± 18.7 ) years ] underwent AVR between February.2010 and December 2011.The weight and body surface area (BSA) of the group is( 60.1 ± 11.4 )kg and (1.67 ± 0.21 )m2 respectively.The aortic valve prosthesis effective orifice area (EOA) was divided by body surface area (BSA) to obtain the EOA index (EOAI).PPM was then defined as none or mild if EOAI was ＞ 0.85 cm2/m2,as moderate for (0.65 - 0.85 ) cm2/m2 and as severe for ＜ 0.65 cm2/m2.To avoid PPM,a simple three-step algorithm was applied:Step 1,Calculate the patient's BSA from weight and height;Step 2,Calculate the minimal valve EOA required based on the BSA to ensure an EOAI ＞0.85 cm2/m2 ; Step 3,Select the type and size of prosthesis that has reference values for EOA greater or equal to the minimal EOA value obtained in step 2.For patients with a small aortic root,the following three methods was used:( 1 ) Replace aortic valve with simple interrupted suture technique ; (2) Apply new type and high-performance prosthetic valves such as St.Jude Medical Regent mechanical valve ; (3) Enlarge the narrowed aortic root when necessary.Results Of all 357 patients,272 patients received mechanical AVR and 85 bioprosthetic AVR.Among the 49 patients who received AVR with simple interrupted suture technique.St.Jude Medical Regent mechanical valve was implanted in 38 patients and the aortic root enlargement was performed in 11 patients.The total prevalence of PPM was 6.4％ and there was no severe PPM.The prevalence of PPM with mechanical AVR and bioprosthetic AVR was 1.8％ and 21.2％ respectively.There were 4 deaths during early period of operation,and the operative mortality was 1.1％.Conclusion Prosthesis-patient mismatch can be effectively prevented at the time of AVR with appropriate measurement.

Current status of prosthesis-patient mismatch after valve replacement / 国际外科学杂志

Valve replacement is the primary means of treatment of valvular disease. With the further research of artificial valve, Prosthesis-patient mismatch is becoming a hot research hotspot. This paper reviews research status of Prosthesis-patient mismatch.

Prosthesis-patient mismatch: Recent progress / 第二军医大学学报

Prosthesis-patient mismatch occurs when the effective orifice area of the prothesis is too small according to the patient's body size after insertion, which may consequently result in consistent presence of eignificant residual transvalvular pressure gradients postoperativtly, hampeeing the prognoses of patients. Currency the indexed effective oeitice area measured by postoperative transthoracic echocardiography is considered the only appropriate parameter which can accurately desceibe the mismatch. Valves of various types can have very different indexed effective orifice areas, so the incidence of mismatch also vaeies. Recently, the mismatch following transcatheter aortic valve implantation is drawing increasing attention. The clinical implication of prosthesis-patient mismatch is still debated. Many factors, including the indices, standard and other mixing factors, together with the age, preoperative cardiac function and types of valve disease of patients can be related to the mismatch, the previous conclusions have been various. Prosthesis-patient mismatch may cause a greater influence to patients with left heart dysfunction and young patients. It can be largtly prevented by choosing prostheses of appropriate size or by enlarging the aortic root by operation if necessary; a final decision should be made according to the patients' condition. Severe mismatch and mismatch in patients with severe cardiac dysfunction should be avoided. In this paper we reviews the recent progress on prosthesis-patient mismatch.

Desproporción prótesis-paciente en la cirugía de sustitución valvular aórtica y mortalidad quirúrgica / Disproportion prosthesis-patient surgery for aortic valve replacement and surgical mortality

La incidencia de desproporción prótesis-paciente (DPP), expresada como área del orificio efectivo indexada (AOEI), varía entre 19%-70% y su efecto sobre la morbimortalidad es controvertido. Esto es de interés debido a la frecuencia del procedimiento. Objetivo: determinar la incidencia acumulada de DPP y mortalidad quirúrgica en pacientes elegidos para cirugía de sustitución valvular aórtica (CSVA). Material y método: entre enero de 2004 y junio de 2007 se realizaron 131 CSVA en portadores de estenosis aórtica. Caso incidente de DPP: si AOEI < 0,85 cm2/m2; moderada, entre 0,85- 0,65 y severa < 0,65. En 13 (9,9%) no fue posible determinar el área del orificio efectivo (AOE). La mortalidad quirúrgica se considera según la Society of Thoracic Surgeons (EE.UU.). Las incidencias acumuladas (IC95%) se calcularon estratificadas por severidad de la DPP. La asociación DPP - mortalidad quirúrgica se exploró por probabilidad exacta. Resultado: la incidencia acumulada de DPP fue 41/118 (34,7%, IC95%: 26%-44%), moderada en 26/118 pacientes (22,0%, IC95%: 15%-31%) y severa en 15/118 (12,7%, IC95%: 7%-20%). En todos, la mortalidad quirúrgica fue 10/131 (7,6%, IC95%: 4%-14%), y en los que se estimó DPP fue 9/118 (7,6%, IC95%: 4%-14%). En los pacientes sin DPP fue 6/77 (7,8%, IC95%: 3%-17%) similar a los con DPP que fue 3/41 (7,3%, IC95%: 2%-20%), p=1. En la DPP moderada la mortalidad quirúrgica fue 1/26 (3,8% IC95%: 1%-19%) y en DPP severa 2/15 (13%, IC95%: 2%-40%). Conclusión: más del 30% de los pacientes con CSVA tuvieron DPP, siendo severa en 13%. No se encontró asociación entre DPP y mortalidad quirúrgica.

The incidence of prosthesis-patient mismatch (PPM) expressed as the indexed effective orifice area (IEOA) varies between 19%-70% and its effect on morbidity and mortality is controversial. This is of interest because the frequency of the procedure.Objective: determine cumulative incidence of PPM and surgical mortality in patients selected for aortic valve replacement surgery (AVRS). Material and method: between January 2004 and June 2007, 131 surgeries for aortic stenosis were done. PPM incident case if AOEI <0,85 cm2/m2; moderate between 0,85-0,65 and severe <0,65. In 13 (9,9%) was not possible to determine EOA. Surgical mortality is considered as the Society of Thoracic Surgeons, USA. The cumulative incidence (95% CI) were calculated stratified by severity of the PPM. The association PPM - surgical mortality was explored by exact test. Results: The cumulative incidence of PPM was 41/118 (34,7%, 95% CI: 26%-44%), moderate in 26/118 patients (22,0%, 95% CI: 15%-31%) and severe in 15/118 (12,7 %, 95% CI: 7%-20%). In all the surgical mortality was 10/131 (7,6%, 95% CI: 4%-14%), and the PPM was estimated to be 9 / 118 (7,6%, 95% CI: 4%-14%). In patients without PPM was 6 / 77 (7,8%, 95% CI: 3%-17%) similar to the PPM which was 3 / 41 (7,3%, 95% CI: 2%-20%), p=1. In the PPM moderate surgical mortality was 1/26 (3,8%, 95% CI: 1%-19%) and severe PPM 2/15 (13%, 95% CI: 2%-40%). Conclusion: more than 30% of patients with AVRS had PPM, being severe in 13%. No association was found between PPM and surgical mortality.