Transcatheter aortic valve implantation: the evidence

Abstract

Transcatheter aortic valve implantation (TAVI) is the new standard-of-care for inoperable patients with better outcome than conservative management, including balloon valvuloplasty only. In high-risk patients, TAVI has clearly shown non-inferiority compared with surgical aortic valve replacement. Although data from national multicentre registries are very encouraging and we are already speculating about the use of TAVI in intermediate-risk patients, it is of note that the two commercially available and used transcatheter heart valves (THVs) have not yet been assessed by randomised clinical trials in those patients. Technological advances promise to simplify TAVI and to improve outcome by reducing the rate of TAVI-specific issues such as stroke, peri-prosthetic aortic regurgitation, acute kidney injury, vascular complications and conduction disturbances. Therefore, results from ongoing trials with the available THVs are urgently awaited. In future trials, screening, treatment and follow-up of TAVI patients will need to follow a standardised protocol to achieve better comparability of study data to address, decisively, the question of whether intermediate-risk or low-risk patients may also profit from a less invasive TAVI approach.

Almanac 2013: novel non-coronary cardiac interventions

“…Importantly, TAVI should currently not be performed in patients at intermediate surgical risk until more data for this group of patients are available, for example, from the ongoing SURTAVI (Surgery and Transcatheter Aortic Valve Implantation) trial (NCT01586910). 34 treba izvoditi u bolesnika sa srednjim rizikom od kirurπkog zahvata dok ne bude dostupno viπe podataka za ovu skupinu bolesnika, primjerice podaci trenutnog istraaeivanja SURTAVI (Kirurπka i transkateterska implantacija aortalne valvule) (NCT01586910). 34 Smjernice American College of Cardiology (ACC) iz 2012. su vrlo sliËne i jednako podraeavaju odluku multidisciplinarnog tima za bolesnike s visokim rizikom za operacije, definirajuÊi "previsoki rizik za operaciju" kao procijenjeni pojavu ≥50% rizik od smrti ili ireverzibilnog morbiditeta u prvih 30 dana.…”

“…34 treba izvoditi u bolesnika sa srednjim rizikom od kirurπkog zahvata dok ne bude dostupno viπe podataka za ovu skupinu bolesnika, primjerice podaci trenutnog istraaeivanja SURTAVI (Kirurπka i transkateterska implantacija aortalne valvule) (NCT01586910). 34 Smjernice American College of Cardiology (ACC) iz 2012. su vrlo sliËne i jednako podraeavaju odluku multidisciplinarnog tima za bolesnike s visokim rizikom za operacije, definirajuÊi "previsoki rizik za operaciju" kao procijenjeni pojavu ≥50% rizik od smrti ili ireverzibilnog morbiditeta u prvih 30 dana. 35 Iako su ove smjernice novijeg datuma, s rastuÊim iskustvom indikacija za TAVR se brzo πiri u nekim zemljama.…”

Transcatheter aortic valve replacement

“…This result could have been due to a statistical coincidence or insufficient preoperative imaging; nevertheless, the results of this study should be taken into account before prematurely suggesting TAVR to lower-risk patients. 8,23 Long …”

“…Risk factors for acute kidney injury may include peripheral vascular disease, bleeding, blood transfusion, post-procedural aortic regurgitation, and the use of high amounts of contrast medium. 6,8,34,[98][99][100][101] valve malpositioning, embolization, and other complications Malpositioning of the valve can lead to aortic regurgitation, coronary artery obstruction, injury to the aorta or to the mitral valve, arrhythmia or conduction disturbances, and embolization of the valve. 44 In their meta-analysis on adverse events after TAVR, Khatri et al reported an overall rate of valve in valve implantation for implant failure of 2.2% with a higher rate among patients receiving a CoreValve implantation.…”

“…However, registries allow the inclusion of large patient samples and observation of patient outcomes in a real-world setting. 7,8 Major registries and important outcome data are summarized in Table 1. The French Aortic National CoreValve and Edwards (FRANCE) 2 registry is currently the largest published registry and includes 3195 patients.…”