Experiencia multicéntrica de implante valvular aórtico percutáneo discriminada por riesgo en centros de Latinoamérica / Multicenter Experience of Transcatheter Aortic Valve Implantation Stratified by Risk in Latin American Centers

RESUMEN Introducción: El implante valvular aórtico percutáneo ha sido valorado en diferentes escenarios del amplio espectro de la población portadora de estenosis aórtica grave sintomática. La elección del tipo de tratamiento parte de una evaluación del riesgo de un equipo multidisciplinario. Objetivos: El objetivo de este estudio fue analizar las características y conocer los resultados de los pacientes sometidos a IVAP en Latinoamérica según el riesgo. Material y métodos: Se incluyeron a partir de marzo de 2009 a diciembre de 2018 pacientes en forma continua del registro multicéntrico latinoamericano de implante valvular aórtico percutáneo. La indicación de implante valvular aórtico percutáneo fue realizada en cada caso por un equipo multidisciplinario local. Se estratifica la población en función del riesgo quirúrgico evaluado por el puntaje STS-PROM. Se definieron tres grupos en función de los puntos de corte del STS -PROM establecidos: riesgo alto (RA, mayor del 8%), riesgo intermedio (RI, entre el 4% y el 8%) y riesgo bajo (RB, menordel 4%). Resultados: Se incluyeron en el análisis 770 pacientes; la mitad era de sexo femenino (50,2%) con una mediana de edad de 81 años (RIC 75,6-85,7). Del total, 230 pacientes (29,8%) fueron incluidos en el grupo AR (STS-PROM medio 11 [9,3-16,7]); 339 pacientes (44%), al riesgo intermedio (STS-PROM medio 6 [4,8-6,71]); y los restantes 201 (26,1%), al bajo riesgo (STS-PROM medio 2,7 [2-3,24]). La proporción de pacientes de bajo riesgo se incrementó a lo largo del período del registro (ptrend 0,011). Se utilizó acceso femoral (95%), y fue percutáneo en el 69% de los pacientes. Se implantaron en el 80% válvulas autoexpandibles. Del total de válvulas implantadas, el 23% (n = 177) resultaron ser reposicionables sin diferencias a través de los grupos. No se evidenciaron diferencias en mortalidad a los 30 días (RA 10,4%, RI 6,48%, RB 5,9%, p: 0,154) Tanto en el RA como en el de RB se observó una reducción de la mortalidad (RA 13,7%-4,1%, p: 0,001; RB 11,7%-0%; p: 0,0023). Conclusiones: La estratificación de riesgo mediante puntajes quirúrgicos continúa representando una guía de gran utilidad, sin embargo la indicación de implante valvular percutáneo en el mundo real incorpora otros factores no contemplados en la puntuación clásica, que modifica nuestras decisiones en la práctica diaria.

SUMMARY Introduction: Transcatheter aortic valve implantation (TAVI) has been evaluated in different scenarios of the broad spectrum of patients with severe symptomatic aortic stenosis. The choice of treatment starts through a risk assessment guided by a multidisciplinary team. Purpose: The aim of this study was to analyze the population undergoing TAVI in Latin America according to their risk. Methods: From March 2009 to December 2018, consecutive TAVI procedures registered in the Latin American multicenter registry were included. The indication of TAVI was made in each case by a multidisciplinary team set up by each center. The population is stratified according to the surgical risk evaluated by the STS-PROM score. Three groups were defined, based on the established STS-PROM cut-off points: high risk (RA, higher 8%), intermediate risk (IR, between 4%-8%) and low risk (RB, lower 4%). Results: 770 patients were included in the analysis, resulting 50,2% female, with a mean age of 81 y/o (IQR 75.6-85.7). 29.8% were included in the AR group (STS-PROM 11 (9.3-16.7), 44% at intermediate risk (STS-PROM 6 (4.8-6.71) and 26.1% at low risk (STS-PROM 2.7 (2-3.24). The proportion of low-risk patients has increased significantly over the period of inclusion (ptrend 0.011). Femoral access (95%), being percutaneous in 69% of patients. Self-expanding valves were implanted in 80%. 23% of the valves were repositionable without differences across the groups. There was no differences in 30-day mortality (RA 10.4%, IR 6.48%, RB 5.9%, p 0.154). Reduction in mortality were observed (RA 13, 7-4.1%, p0.001; RB 11.7-0%; p 0.0023) during the analyzed period. Conclusions: Risk stratification through surgical "scores" continues to represent a very useful guide, however the indication of TAVI in the real world incorporates other factors not contemplated in the classical score, which modifies our decisions in daily practice.

Incidence of Conduction Disorders and Requirements for Permanent Pacemaker After Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or non-operable patients with severe symptomatic aortic stenosis. Atrioventricular conduction disturbances requiring permanent pacemaker (PPM) are a common and clinically important complication. Objectives: To evaluate the incidence of conduction disorders (CDs) after TAVI and the need for subsequent PPM implantation. To identify the predictors of postoperative PPM implantation. Methods: Retrospective study. All patients who underwent TAVI in a public hospital from December/2011 to June/2016 were included. Multivariate analysis was conducted to establish the predictor of permanent pacemaker implantation. Survival curves were constructed by the Kaplan-Meyer method. Statistically significant variables were those with p value < 0.05. Results: 64 patients with AS underwent TAVI. Eleven patients were excluded. TAVI induced a new CD in 40 (77%) of the remaining 53 patients. The most common new CDs were 3rd degree AV block (32%) and left bundle branch block (30%). Sixteen patients (30,2%) underwent PPM implantation during the index hospitalization. On univariate analysis the risk factors for PPM implantation were CoreValve® use (OR: 1,76; P = 0,005), larger prosthesis implantation (P = 0,015), presence of a QRS ≥ 120 ms (OR: 5,62; P = 0,012), and 1st degree AV block (OR: 13; P = 0.008). On multivariate analysis the presence of 1st degree AV block predicted the need for PPM. Conclusion: TAVI induced CDs requiring PPM in 30% of the patients. The presence of 1st degree AV block predicted the need for PPM

Balloon Repositioning of Transcatheter Aortic Valve after Migration into the Left Ventricular Outflow Tract, Followed by Valve-in-Valve Procedure.

Transcatheter aortic valve replacement is an established option for treating patients with symptomatic aortic stenosis; however, severe, life-threatening complications, such as valve migration, are possible. We report the case of an 82-year-old woman whose Edwards Sapien XT valve migrated into the left ventricular outflow tract one day after transcatheter aortic valve replacement. We used an inflated balloon to adjust the position of the migrated valve before performing a valve-in-valve procedure via a transapical approach, which resulted in a good valve implantation.

Transcatheter Aortic Valve Implantation in a Patient with Unicuspid Aortic Valve.

Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valves has been successfully performed, but there is a lack of published experience in percutaneous treatment of patients with unicuspid valves and severe aortic stenosis. We describe a case of TAVR in such a patient. A 31-year-old woman with Turner syndrome-who had undergone coarctation repair via subclavian flap at age 7 days and an aortic valvotomy at age 6 weeks-presented with severe symptomatic aortic stenosis. She was deemed inoperable because of her severe pulmonary hypertension and numerous comorbidities; consequently, a 20-mm Edwards Sapien 3 Transcatheter Heart Valve was offered for compassionate use. Postdeployment angiography and transesophageal echocardiography and aortography revealed no aortic insufficiency. Transcatheter aortic valve replacement for unicuspid aortic valve stenosis is technically feasible. Before implantation, particular attention should be paid to the interplay between the large single leaflet, coronary ostia, and stented valve, to select the correct size and position of the device. Some degree of intraoperative aortic migration should be anticipated.

Successful transfemoral aortic valve implantation through aortic stent graft after endovascular repair of abdominal aortic aneurysm.

The patient was a 91-year-old woman presenting with severe aortic valve stenosis. Pre-procedural computed tomography scan revealed a 45-mm abdominal aortic aneurysm (AAA). Transfemoral transcatheter aortic valve implantation (TF-TAVI) was performed after endovascular aortic repair (EVAR) of the AAA. The 23-mm Edwards Sapien XT system passed through the aortic stent graft smoothly. This is the first case report showing that successful TF-TAVI can be performed through a prior abdominal aortic stent graft. TF-TAVI after EVAR of AAA is a feasible option for patients with extremely poor access.

Delayed-Onset Left Main Coronary Artery Obstruction More than 24 Hours after Balloon-Expandable Transcatheter Aortic Valve Replacement.

Coronary obstruction during or after transcatheter aortic valve replacement is a rare and catastrophic sequela that occurs most frequently just after valve implantation. Even rarer is the delayed clinical presentation, in some few patients, of coronary obstruction on the day after self-expandable valve implantation. Here we describe a case of balloon-expandable (not self-expandable) transcatheter aortic valve replacement, followed by partial obstruction of the left main coronary artery on the day after that procedure in a 93-year-old man, despite normal left ventricular contraction just after valve implantation. Visual evaluation of the echocardiogram for left ventricular wall motion was not sufficient, by itself, to achieve early diagnosis of the obstruction. We performed emergency percutaneous coronary intervention. Ninety days after the procedure, the patient was in New York Heart Association functional class I.

Transcatheter aortic valve implantation despite challenging vascular access.

We describe transcatheter aortic valve implantation in a patient who had severe peripheral artery disease. The patient's vascular condition required additional preliminary peripheral intervention to enable adequate vascular access. A 78-year-old man with severe aortic stenosis, substantial comorbidities, and severe heart failure symptoms was referred for aortic valve replacement. The patient's 20-mm aortic annulus necessitated the use of a 23-mm Edwards Sapien valve inserted through a 22F sheath, which itself needed a vessel diameter of at least 7 mm for percutaneous delivery. The left common femoral artery was selected for valve delivery. The left iliac artery and infrarenal aorta underwent extensive intervention to achieve an intraluminal diameter larger than 7 mm. After aortic valvuloplasty, valve deployment was successful, and the transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The patient was discharged from the hospital 4 days postoperatively. We conclude that transcatheter aortic valve implantation can be successfully performed in patients with obstructed vascular access, including stenosis of the infrarenal aorta and the subclavian and coronary arteries.

Contemporary use of balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation.

The development of transcatheter aortic valve implantation (TAVI) has increased the use of balloon aortic valvuloplasty (BAV) in treating aortic stenosis. We evaluated our use of BAV in an academic tertiary referral center with a developing TAVI program. We reviewed 69 consecutive stand-alone BAV procedures that were performed in 62 patients (mean age, 77 ± 10 yr; 62% men; baseline mean New York Heart Association functional class, 3 ± 1) from January 2009 through December 2012. Enrollment for the CoreValve(®) clinical trial began in January 2011. We divided the study cohort into 2 distinct periods, defined as pre-TAVI (2009-2010) and TAVI (2011-2012). We reviewed clinical, hemodynamic, and follow-up data, calculating each BAV procedure as a separate case. Stand-alone BAV use increased 145% from the pre-TAVI period to the TAVI period. The mean aortic gradient reduction was 13 ± 10 mmHg. Patients were successfully bridged as intended to cardiac or noncardiac surgery in 100% of instances and to TAVI in 60%. Five patients stabilized with BAV subsequently underwent surgical aortic valve replacement with no operative deaths. The overall in-hospital mortality rate (17.4%) was highest in emergent patients (61%). The implementation of a TAVI program was associated with a significant change in BAV volumes and indications. Balloon aortic valvuloplasty can successfully bridge patients to surgery or TAVI, although least successfully in patients nearer death. As TAVI expands to more centers and higher-risk patient groups, BAV might become integral to collaborative treatment decisions by surgeons and interventional cardiologists.

Left main coronary artery obstruction by dislodged native-valve calculus after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement can be an effective, reliable treatment for severe aortic stenosis in surgically high-risk or ineligible patients. However, various sequelae like coronary artery obstruction can occur, not only in the long term, but also immediately after the procedure. We present the case of a 78-year-old woman whose left main coronary artery became obstructed with calculus 2 hours after the transfemoral implantation of an Edwards Sapien XT aortic valve. Despite percutaneous coronary intervention in that artery, the patient died. This case reminds us that early recognition of acute coronary obstruction and prompt intervention are crucial in patients with aortic stenosis who have undergone transcatheter aortic valve replacement.

Cerebral protection against left ventricular thrombus during transcatheter aortic valve replacement in a patient with critical aortic stenosis.

Transcatheter aortic valve replacement is an increasingly common treatment of critical aortic stenosis. Many aortic stenosis patients have concomitant left ventricular dysfunction, which can instigate the formation of thrombus resistant to anticoagulation. Recent trials evaluating transcatheter aortic valve replacement have excluded patients with left ventricular thrombus. We present a case in which an 86-year-old man with known left ventricular thrombus underwent successful transcatheter aortic valve replacement under cerebral protection.

Transcatheter aortic valve replacement in a nonagenarian.

Approximately 30% to 40% of elderly patients with severe, symptomatic aortic valve stenosis are deemed ineligible for surgery because of high perioperative risk. We describe the use of an alternative transfemoral approach known as transcatheter aortic valve implantation in a nonagenarian patient with severe aortic stenosis. Our patient recovered successfully, and by the time of her most recent follow-up visit, 7 months after the procedure, she had regained a substantial degree of function. This result suggests that transcatheter aortic valve implantation can enable some high-risk patients who are ineligible for surgery to undergo valve replacement, thereby regaining both quality and length of life.