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Abstract
Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.
Highlights
Significant differences were found in NYHA class, prior valvuloplasty, peak aortic gradient, aortic valve area, aortic regurgitation, porcelain aorta, family history of CAD, hypertension, current smoking, prior CAD, angiographic CAD, prior acute pulmonary edema, prior myocardial infarction, prior percutaneous coronary intervention, syncope, carotid artery disease, peripheral artery disease, systolic blood pressure, diastolic blood pressure, hematocrit, oxygen dependency, prior cancer, LVEDV, LVESV, bicuspid aortic valve, and ilio-femoral tortuosity
At unadjusted analysis using tertiles, instituions at high overall volume showed lower rates of major adverse events, death, and myocardial infarction than other centers, whereas pacemaker implantations (PPI) appeared less common in low volume institutions (p = 0.009)
All recent reports reaffirm the safety of Transcatheter aortic valve implantation (TAVI), confirming its established role in patients with aortic stenosis at intermediate to prohibitive surgical risk, and sustaining recent trials testing the role of TAVI in low risk patients[2,3]
Summary
The main aim of this RISPEVA subanalysis was to compare patients undergoing attempted implantation of Acurate, Evolut, Lotus, Portico, or Sapien[3] devices, focusing on short-term (procedural, peri-procedural, and 1-month) outcomes. All patients in whom TAVI was attempted at participating centers and willing to provide consent were offered inclusion in the study, without any additional selection criterion. Procedural outcomes included: contrast volume, fluoroscopy time, procedural time, device success, procedural success, death, valve migration, anulus rupture, surgical conversion, coronary occlusion, myocardial infarction, pericardial tamponade, aortic dissection, major vascular complication, and major bleeding. Details on the following clinically relevant outcomes were systematically collected: death, cardiac death, surgical aortic valve replacement, valve thrombosis, valve degeneration, endocarditis, coronary occlusion, myocardial infarction, pericardial effusion, stroke, transient ischemic attack, major vascular complication, amputation, major bleeeding, renal failure, and PPI. Computations were performed with Stata 13 (StataCorp, College Station, TX)
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