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1.
J Card Surg ; 35(6): 1186-1194, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32349178

RESUMEN

BACKGROPUND AND AIM: Postoperative thrombocytopenia after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) and aggravating causes were the aim of this retrospective study. METHODS: Data of all patients treated with SAVR (n = 1068) and TAVR (n = 816) due to severe aortic valve stenosis was collected at our center from 2010 to 2017. Preprocedural and postprocedural values were collected from electronic patient records. RESULTS: There was a significant drop in platelets in both groups, the TAVR group showed overall superior platelet preservation compared to the AVR group (P < .001). In the SAVR subgroup analysis, a significant difference in platelet preservation was observed between the valve types (P < .001), particularly with the Freedom SOLO valve. In the TAVR subgroup analysis, the valve type did not influence platelet count (PLT) reduction (P = .13). In the SAVR subgroup analyses, PLT was found to be worsened with cardiopulmonary bypass (CPB) duration. CONCLUSION: Thrombocytopenia frequently occurs after implantation of a biological heart valve prosthesis, with a higher frequency observed in patients after cardiac surgery rather than TAVR. Although some surgical bioprosthetic models are more susceptible to this phenomenon, CPB duration seems to be a major determinant for the development of postoperative thrombocytopenia.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Bioprótesis/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Prótesis Valvulares Cardíacas/efectos adversos , Complicaciones Posoperatorias/etiología , Trombocitopenia/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Puente Cardiopulmonar/efectos adversos , Femenino , Humanos , Masculino , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Trombocitopenia/sangre , Trombocitopenia/epidemiología , Factores de Tiempo
2.
Europace ; 21(5): 787-795, 2019 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-30629159

RESUMEN

AIMS: To assess the contribution of aortic valve calcification to the occurrence of transient or permanent atrioventricular block (AVB) and the need for permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) in a large single-centre cohort. METHODS AND RESULTS: We retrospectively analysed pre-operative contrast-enhanced multidetector computed tomography scans of patients who underwent TAVI in our centre between 2012 and 2016. Calcium volume was calculated for each aortic cusp above (aortic valve), and below [left ventricular outflow tract (LVOT)] the basal plane. Clinical and procedural data as well as pre-operative electrocardiograms were evaluated. Multivariate analysis was performed to evaluate risk factors for transient and permanent AVB. A total of 342 patients receiving a balloon-expandable prosthesis were included in the study. Overall incidence of transient and permanent AVB was 4% (n = 14) and 7.6% (n = 26), respectively. On logistic regression analysis, baseline right bundle branch block [odds ratio (OR) 7.36, 95% confidence interval (CI) 2.6-20.6; P < 0.01], degree of oversizing (OR 1.04, 95% CI 1.01-1.07 P = 0.02), prior percutaneous coronary intervention (OR 2.8, 95% CI 1.1-7.3), and LVOT calcification beneath the non-coronary cusp (OR for an increase of 10 mm3 = 1.06, 95% CI 1-1.1; P = 0.03) were found to be independently associated with permanent AVB and PPI, whereas calcification of LVOT beneath the right coronary cusp (OR for an increase of 10 mm3 = 1.16, 95% CI 1.02-1.3; P = 0.02) and balloon post-dilation (OR 3.8, 95% CI 1.2-11.8; P = 0.02) were associated with reversible AVB. CONCLUSION: Left ventricular outflow tract calcifications are associated with transient and non-reversible AVB after TAVI, and its evaluation could help in predicting onset and reversibility of AVB.


Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica/patología , Bloqueo Atrioventricular , Fascículo Atrioventricular/lesiones , Calcinosis , Estimulación Cardíaca Artificial , Complicaciones Intraoperatorias , Tomografía Computarizada Multidetector/métodos , Complicaciones Posoperatorias , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Bloqueo Atrioventricular/diagnóstico , Bloqueo Atrioventricular/etiología , Calcinosis/diagnóstico , Calcinosis/epidemiología , Calcinosis/cirugía , Estimulación Cardíaca Artificial/métodos , Estimulación Cardíaca Artificial/estadística & datos numéricos , Electrocardiografía/métodos , Femenino , Alemania , Humanos , Complicaciones Intraoperatorias/etiología , Complicaciones Intraoperatorias/prevención & control , Masculino , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/terapia , Valor Predictivo de las Pruebas , Periodo Preoperatorio , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/métodos
3.
J Heart Valve Dis ; 26(3): 255-261, 2017 05.
Artículo en Inglés | MEDLINE | ID: mdl-29092108

RESUMEN

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI), especially via the transfemoral (TF) route, is increasingly performed in patients considered in the 'gray zone' between TAVI and surgery. However, the best treatment option in this patient population remains to be established. METHODS: Since 2010, a total of 923 patients underwent either TAVI (n = 538) or sutureless aortic valve replacement (AVR) (n = 385) at the authors' institutions. Among these patients, 79 treated with TF-TAVI were compared with 79 propensity score-matched patients who had undergone elective isolated AVR with the sutureless Perceval bioprosthesis. RESULTS: In-hospital mortality did not differ significantly between patients who underwent sutureless AVR or TF-TAVI (none versus three; 3.8%; p = 0.123). Similarly, postoperative complications were comparable between groups. Atrioventricular block requiring postoperative pacemaker implantation occurred in seven patients (9.2%) of the sutureless group and in eight patients (11.1%) of the TF-TAVI group (p = 0.455). The use of blood products varied between groups in terms of red blood cell transfusions (1.7 ± 2 versus 0.3 ± 0.9 units for the sutureless group versus TF-TAVI group; p <0.001). Paravalvular leakage at discharge was present in three patients (3.8%) in the sutureless group and in 26 patients (32.9%) in the TF-TAVI group (p <0.001). The mean follow up was longer for sutureless AVR (36 ± 21 versus 27 ± 20 months; p = 0.003). Survival rates were 97.5% and 84.8% in the sutureless and TF-TAVI groups, respectively (p = 0.001). CONCLUSIONS: Both, TF-TAVI and sutureless AVR are well-standardized, safe and effective procedures. TF-TAVI seems to be a valuable alternative to surgical AVR for frail patients, reducing the need for perioperative blood transfusion. In contrast, in patients with a favorable long-term survival outcome, minimally invasive AVR remains the procedure of choice as it is associated with better long-term results.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Procedimientos Quirúrgicos sin Sutura , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Bloqueo Atrioventricular/etiología , Bloqueo Atrioventricular/fisiopatología , Bloqueo Atrioventricular/terapia , Bioprótesis , Pérdida de Sangre Quirúrgica/prevención & control , Transfusión Sanguínea , Estimulación Cardíaca Artificial , Distribución de Chi-Cuadrado , Femenino , Alemania , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Mortalidad Hospitalaria , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Análisis Multivariante , Selección de Paciente , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Factores de Riesgo , Procedimientos Quirúrgicos sin Sutura/efectos adversos , Procedimientos Quirúrgicos sin Sutura/mortalidad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
4.
J Card Surg ; 32(7): 407-409, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28589570

RESUMEN

Despite advances in surgical techniques for mitral valve repair, more than 20% of patients require reoperation within 10 years due to recurrence of severe mitral regurgitation. However, reoperations on the mitral valve are often associated with increased morbidity and mortality. We report a transapical mitral valve-in-ring implantation in a patient who had undergone mitral valve repair for ischemic mitral regurgitation using a complete semi-rigid Memo 3D mitral ring (LivaNova Group, Milan, Italy).


Asunto(s)
Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Anuloplastia de la Válvula Mitral , Insuficiencia de la Válvula Mitral/cirugía , Anciano , Humanos , Persona de Mediana Edad , Resultado del Tratamiento
5.
Heart Surg Forum ; 19(4): E169, 2016 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-27585194

RESUMEN

Thrombocytopenia occurring after surgical bioprosthetic valve implantation is a phenomenon that has been long investigated, and various explanations have been provided [Santarpino 2012a]. Our group has been addressing this topic over several years, extending back to the original description of this phenomenon in Freedom Solo (Sorin Group, Saluggia, Italy). However, we observed that this was a transitory and self-limited phenomenon without clinical consequence [Santarpino 2011; Santarpino 2012a]. Our center began implanting the Perceval aortic valve (Sorin Group, Saluggia, Italy) in 2010, and we have gained a vast experience in sutureless aortic valve replacement with Perceval, with more than 300 implants performed to date [Fischlein 2015].


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Procedimientos Quirúrgicos sin Sutura/métodos , Trombocitopenia/etiología , Anciano , Estenosis de la Válvula Aórtica/complicaciones , Humanos , Recuento de Plaquetas , Diseño de Prótesis , Trombocitopenia/sangre
6.
Thorac Cardiovasc Surg ; 63(6): 467-71, 2015 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-26177222

RESUMEN

INTRODUCTION: Despite increased operative time, minimally invasive cardiac surgery is associated with a lower morbidity than conventional aortic valve replacement (AVR). On the other hand, sutureless aortic bioprostheses have the potential of simplifying implantation, as it reduces the ischemic time. Our aim was to investigate the outcome of a sutureless AVR through a mini-sternotomy. MATERIALS AND METHODS: Since March 2010, a total of 262 patients affected by aortic valve stenosis underwent AVR with a sutureless bioprosthesis (Perceval, Sorin Group, Saluggia, Italy). Of these, 145 patients (mean age 77.8 ± 4.7 years, 80 women) underwent surgical AVR through a mini J-sternotomy. Clinical and echocardiographic data were evaluated. RESULTS: Patients received a size: S(12), M(49), L(67), or XL(17) prostheses, either as isolated (131) or combined procedures (14) including 2 redo patients who had undergone coronary artery bypass grafting via full sternotomy previously. Mean logistic EuroSCORE (I) was 9.9 ± 5.9%, and mean aortic cross-clamp time was 38 ± 12 minutes (35 ± 11 minutes in isolated procedures). Two conversions to full sternotomy were necessary because of bleeding. Thirty-day mortality was 2.1% (all noncardiac deaths); mean hospital stay was 11.6 ± 4.9 days. We recorded 11 pacemaker implantations (7.6%). At follow-up (23.5 ± 14.4 months), five patients were dead (three noncardiac and two cardiac deaths). At echocardiographic control, mean transprosthetic gradients were as follows: 12.8 ± 4.9, 12.5 ± 4.5, 11.8 ± 4.7 mm Hg, postoperatively at 6 months, 1 year, and 2 years, respectively. No paravalvular leaks were recorded. CONCLUSION: The sutureless bioprosthesis shows satisfactory clinical and hemodynamic results. Owing to its simple implantation technique, it represents a good support for minimally invasive access surgery via J-sternotomy.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Esternotomía/métodos , Técnicas de Sutura , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Diseño de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento
8.
Monaldi Arch Chest Dis ; 82(2): 112-4, 2014 Jun.
Artículo en Italiano | MEDLINE | ID: mdl-25845096

RESUMEN

The implantation of sutureless bioprosthesis is currently not recommended in patients affected by bicuspid aortic valve because lacking data and follow up. We report the first case of a patient affected by bicuspid aortic valve stenosis and aneurysm of non coronary sinus of Valsalva that underwent a successful substitution of aneurysmatic sinus and minimal invasive sutureless implantation.


Asunto(s)
Aneurisma de la Aorta/complicaciones , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Seno Aórtico , Anciano , Válvula Aórtica/anomalías , Estenosis de la Válvula Aórtica/complicaciones , Enfermedad de la Válvula Aórtica Bicúspide , Enfermedades de las Válvulas Cardíacas/complicaciones , Prótesis Valvulares Cardíacas , Humanos , Masculino , Procedimientos Quirúrgicos Mínimamente Invasivos
9.
J Heart Valve Dis ; 22(5): 615-20, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24383371

RESUMEN

BACKGROUND AND AIM OF THE STUDY: The study aim was to report the results of a single-center cohort of patients who underwent aortic valve replacement (AVR) with a sutureless prosthesis in case of cardiac reoperation (REDO). METHODS: Between March 2010 and December 2011, a total of 83 patients underwent AVR with the Perceval S sutureless aortic bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy) at the authors' institution. Thirteen of these patients (six males, seven females; mean age 75.2 +/- 5.6 years) had previously undergone cardiac surgery and represented the study population. Preoperative, periprocedural and echocardiographic parameters, as well as clinical outcomes, were analyzed for all patients. RESULTS: The primary procedure was AVR, using a bioprosthesis in six patients (46%) and coronary artery bypass grafting in seven (54%). The logistic EuroSCORE was 19.4 +/- 10.7%. Surgery was always performed via a full sternotomy; the mean implanted valve size was 23.6 +/- 1.3 mm (the previous valve size was 23.2 +/- 3.2 mm; p = 0.66). The mean cross-clamp time was 44 +/- 16 min, and the mean intensive care unit stay was 3.3 +/- 2.3 days. No intraoperative or in-hospital deaths occurred, and all patients were alive at a mean follow up of 8.5 months. Two postoperative events included transient ischemic attack in one patient, and the need for pacemaker implantation in one patient. On echocardiographic evaluation, no patient showed signs of paraprosthetic leak. The mean transvalvular gradient was 10.3 +/- 1.5 mmHg. CONCLUSION: Use of the Perceval S sutureless AVR offers a fast and safe procedure, even in high-risk REDO surgery, providing a good hemodynamic performance with excellent clinical recovery, demonstrated at a follow up of six months. Although the sample size was limited, the results were encouraging and support the use of sutureless valves in the frame of REDO surgery for aortic valve disease.


Asunto(s)
Válvula Aórtica/cirugía , Bioprótesis , Puente de Arteria Coronaria , Enfermedad Coronaria/cirugía , Enfermedades de las Válvulas Cardíacas/cirugía , Prótesis Valvulares Cardíacas , Técnicas de Sutura , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Enfermedad Coronaria/complicaciones , Ecocardiografía , Femenino , Estudios de Seguimiento , Enfermedades de las Válvulas Cardíacas/complicaciones , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Humanos , Masculino , Reoperación , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento
10.
J Heart Valve Dis ; 22(4): 455-9, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-24224406

RESUMEN

BACKGROUND AND AIM OF THE STUDY: The introduction of transcatheter aortic valve implantation (TAVI), coupled with the increasing number of elderly patients requiring cardiac surgery, has given rise to an intense debate on the most appropriate treatment strategy for this high-risk population. The study aim was to compare clinical outcomes in older versus younger patients undergoing minimally invasive aortic valve replacement (AVR). METHODS: Between March 2010 and July 2012, 66 patients undergoing minimally invasive isolated AVR with the sutureless Perceval S bioprosthesis (Sorin Group, Saluggia, Italy) were allocated to two groups according to age > or = 80 years (group A, n = 25) or < 80 years (group B, n = 41). In-hospital and follow up data were collected for all patients, including an evaluation of the patients' quality of life, using the SF-36 questionnaire. RESULTS: Mean age and logistic EuroSCORE were statistically different between groups (p < 0.001 and p = 0.002, respectively). The length of intensive care unit stay was similar in groups A and B (1.9 +/- 0.8 and 2.5 +/- 1.4 days, respectively; p = 0.061). In-hospital mortality occurred in only one patient of group A (1.5%). Postoperative transient cerebral ischemic events occurred with similar frequency in both groups (two in group A and four in group B; p = 0.59). One patient in group A and two patients in group B required pacemaker implantation (1.5 versus 3%; p = 0.68). The mean follow up was 13.9 +/- 7.4 months, during which time three patients died (two in group A, one in group B). All enrolled patients answered the SF-36 questionnaire, and there were no significant differences between groups in all eight domains of the test. CONCLUSION: Within the setting of minimally invasive isolated AVR, the study results showed that the clinical outcomes and quality of life in patients aged > or = 80 years were comparable to those of younger patients. Therefore, advanced age per se does not preclude successful AVR through a minimally invasive approach.


Asunto(s)
Estenosis de la Válvula Aórtica , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Complicaciones Posoperatorias , Factores de Edad , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/estadística & datos numéricos , Contraindicaciones , Femenino , Alemania , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/estadística & datos numéricos , Mortalidad Hospitalaria , Humanos , Cuidados Intraoperatorios/métodos , Masculino , Procedimientos Quirúrgicos Mínimamente Invasivos , Evaluación de Resultado en la Atención de Salud , Selección de Paciente , Medición de Riesgo , Resultado del Tratamiento
11.
J Geriatr Cardiol ; 19(3): 167-176, 2022 Mar 28.
Artículo en Inglés | MEDLINE | ID: mdl-35464642

RESUMEN

OBJECTIVES: To assess the impact of prosthesis choice and aortic valve calcifications on the occurrence of conduction disturbances after transcatheter aortic valve implantation (TAVI). METHODS: We retrospectively analyzed the preoperative clinical characteristics, electrocardiograms, contrast-enhanced multidetector computed tomography scans and procedural strategies of patients who underwent TAVI in our center between January 2012 and June 2017. Quantification of calcium volume was performed for each aortic cusp above (aortic valve) and below (left ventricular outflow tract, LVOT) the basal plane. Multivariate analysis was performed to evaluate risk factors for the onset of new bundle branch block (BBB), transient and permanent atrioventricular block (tAVB, pAVB). RESULTS: A total of 569 patients were included in the study. Six different prostheses were implanted (Edwards Sapien XT, n = 162; Edwards Sapien 3, n = 240; Medtronic CoreValve, n = 27; Medtronic CoreValve Evolut R, n = 21; Symetis Acurate, n = 56; Symetis Acurate neo, n = 63). The logistic regression analysis for BBB showed association with baseline left anterior hemiblock. The logistic regression for tAVB, found the prior valvuloplasty and the balloon post-dilatation associated with the outcome. Baseline left and right BBB, degree of oversizing, and LVOT calcification beneath the non-coronary cusp were associated with pAVB. Neither the prosthesis model, nor the use of a self-expandable prosthesis showed statistical significance with the above-mentioned outcomes on univariate analysis. CONCLUSIONS: LVOT calcification beneath the non-coronary cusp, baseline left anterior hemiblock, right BBB, balloon post-dilatation, prior valvuloplasty and oversizing are independently associated with postprocedural conduction disturbances after TAVI. Use of a self-expandable prosthesis may show a lower incidence of AVB, if applied in lower calcified aortic valves.

12.
Int J Cardiol ; 368: 56-61, 2022 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-35944771

RESUMEN

BACKGROUND: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS). METHODS: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches. RESULTS: 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%). CONCLUSIONS: Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis.


Asunto(s)
Estenosis de la Válvula Aórtica , Fibrilación Atrial , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Diseño de Prótesis , Estudios Retrospectivos , Esternotomía/métodos , Resultado del Tratamiento
13.
Eur J Cardiothorac Surg ; 62(4)2022 09 02.
Artículo en Inglés | MEDLINE | ID: mdl-35290444

RESUMEN

OBJECTIVES: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS: PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS: The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS: Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697.


Asunto(s)
Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Bioprótesis/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Marcapaso Artificial/efectos adversos , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Resultado del Tratamiento
14.
Front Cardiovasc Med ; 9: 844876, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35252408

RESUMEN

OBJECTIVE: Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab. METHODS: Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance. RESULTS: The site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups. CONCLUSION: At 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

16.
J Thorac Cardiovasc Surg ; 161(3): 920-932, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33478837

RESUMEN

OBJECTIVE: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. METHODS: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year. RESULTS: At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar. CONCLUSIONS: Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Procedimientos Quirúrgicos sin Sutura , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , Tempo Operativo , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Estudios Prospectivos , Diseño de Prótesis , Reoperación , Índice de Severidad de la Enfermedad , Procedimientos Quirúrgicos sin Sutura/efectos adversos , Procedimientos Quirúrgicos sin Sutura/mortalidad , Factores de Tiempo , Resultado del Tratamiento
17.
Acta Crystallogr B ; 66(Pt 1): 27-33, 2010 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20101080

RESUMEN

Rb(1.3711)MnO(2) (Rb(11)Mn(8)O(16)) has been synthesized via the azide/nitrate route from a stoichiometric mixture of the precursors Mn(2)O(3), RbNO(3) and RbN(3). The structure of this extremely air- and moisture-sensitive compound can best be described in terms of an incommensurate composite structure, built up by a honeycomb-like framework of Rb ions, as one subsystem and by a second subsystem of chains, consisting of edge-sharing MnO(4/2) tetrahedra. These two composite substructures interpenetrate in such a way that the manganate chain polyanions centre the channels of the Rb-honeycomb framework. Crystals transform by an aging process into Rb(1.3636)MnO(2) (Rb(15)Mn(11)O(22)), which has a similar structure but a different commensurate modulation. Two reasons can be established for the origin of the modulations: the charge ordering of Mn(2+)/Mn(3+) on one hand, and the incompatibility of the Mn-Mn and Rb-Rb separations on the other.

18.
J Cardiovasc Comput Tomogr ; 14(4): 307-313, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-31874792

RESUMEN

BACKGROUND: Aortic valve calcification is supposed to be a possible cause of embolic stroke or subclinical valve thrombosis after transcatheter aortic valve replacement (TAVR). We aimed to assess the role of aortic valve calcification in the occurrence of in-hospital clinical complications and survival after TAVR. METHODS: We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent TAVR on the native aortic valve in our center. Calcium volume was calculated for each aortic cusp, above and below the aortic annulus. Outcomes were recorded according to VARC-2 criteria. RESULTS: Overall, 581 patients were included in the study (SapienXT = 192; Sapien3 = 228; CoreValve/EvolutR = 45; Engager = 5; Acurate = 111). Median survival was 4.98 years (interquartile range 4.41-5.54). Logistic regression identified calcium load beneath the right coronary cusp in left ventricular outflow tract (LVOT) as significantly associated with stroke (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.03-1.3; p = 0.0019) and in-hospital mortality (OR 1.1; 95% CI 1.004-1.2; p = 0.04), whereas total calcium volume of the LVOT was associated with both in-hospital and 30 day-mortality (OR 1.2; 95% CI 1.01-1.4; p = 0.03, and OR 1.2; 95% CI 1.02-1.43; p = 0.029, respectively). Cox regression identified total calcium of LVOT (hazard ratio [HR] 1.18; 95% CI 1.02-1.38; p = 0.026), male sex (HR 1.88; 95% CI 1.06-3.32; p = 0.031), baseline creatinine clearance (HR 0.96; 95% CI 0.93-0.98; p < 0.001), and baseline severe aortic regurgitation (HR 7.48; 95% CI 2.76-20.26; p < 0.001) as risk factors associated with lower survival. CONCLUSION: LVOT calcification is associated with increased risk of peri-procedural stroke and mortality as well as shorter long-term survival.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/patología , Válvula Aórtica/cirugía , Calcinosis/cirugía , Accidente Cerebrovascular/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Calcinosis/diagnóstico por imagen , Calcinosis/mortalidad , Calcinosis/fisiopatología , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Tomografía Computarizada Multidetector , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/fisiopatología , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
20.
Ann Thorac Surg ; 108(1): 99-105, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-30684479

RESUMEN

BACKGROUND: Several studies reported high rates of postoperative permanent pacemaker (PPM) implantation, which has been described as the "Achilles' heel" of sutureless aortic valve replacement (AVR). METHODS: From July 2010 to December 2017, 3,158 patients with symptomatic, severe aortic valve stenosis were referred to the Department of Cardiac Surgery (Klinikum Nürnberg - Paraclesus Medical University, Nuremberg, Germany), and 512 received a Perceval sutureless bioprosthesis (LivaNova PLC, London, United Kingdom). Thirty-nine patients who had been discharged with concomitant PPM implantation were reevaluated. RESULTS: After a cumulative follow-up of 1,534 months (100% complete, median 50 months, interquartile range 30 months, maximum 76 months, minimum 3 months), a total of 22 patients were still pacemaker dependent. Kaplan-Meier analysis showed pacemaker-dependent rhythm in 92.0%, 80.0%, 49.4%, and 32.3% of patients at 1, 2, 4, and 5 years, respectively. At Cox regression analysis, pressure during valve deployment (hazard ratio, 79.41; p = 0.0003) and "late-onset" atrioventricular block were found to be independent predictors of sinus rhythm restoration (hazard ratio, 0.16; p = 0.0061). Log-rank test showed significantly lower pacemaker dependency rates in patients with "low-pressure" prosthesis implantation (p < 0.0001). CONCLUSIONS: This study shows that several technical measures, including appropriate annulus decalcification, precise positioning of guiding sutures, release of traction sutures applied to the valve commissures, and ballooning with reduced pressure, all reduce the rate of PPM implantation after sutureless AVR. Furthermore, a high proportion of patients were found to be no longer pacemaker dependent at follow-up.


Asunto(s)
Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Marcapaso Artificial , Técnicas de Sutura , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Modelos de Riesgos Proporcionales
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