Background-Permanent pacemaker (PPM) requirement is a recognized complication of transcatheter aortic valve implantation. We assessed the UK incidence of permanent pacing within 30 days of CoreValve implantation and formulated an anatomic and electrophysiological model. Methods and Results-Data from 270 patients at 10 centers in the United Kingdom were examined. Twenty-five patients (8%) had preexisting PPMs; 2 patients had incomplete data. The remaining 243 were 81.3Ϯ6.7 years of age; 50.6% were male. QRS duration increased from 105Ϯ23 to 135Ϯ29 milliseconds (PϽ0.01). Left bundle-branch block incidence was 13% at baseline and 61% after the procedure (PϽ0.001). Eighty-one patients (33.3%) required a PPM within 30 days.Rates of pacing according to preexisting ECG abnormalities were as follows: right bundle-branch block, 65.2%; left bundle-branch block, 43.75%; normal QRS, 27.6%. Among patients who required PPM implantation, the median time to insertion was 4.0 days (interquartile range, 2.0 to 7.75 days). Multivariable analysis revealed that periprocedural atrioventricular block (odds ratio, 6.29; 95% confidence interval, 3.55 to 11.15), balloon predilatation (odds ratio, 2.68; 95% confidence interval, 2.00 to 3.47), use of the larger (29 mm) CoreValve prosthesis (odds ratio, 2.50; 95% confidence interval, 1.22 to 5.11), interventricular septum diameter (odds ratio, 1.18; 95% confidence interval, 1.10 to 3.06), and prolonged QRS duration (odds ratio, 3.45; 95% confidence interval, 1.61 to 7.40) were independently associated with the need for PPM. Conclusion-One third of patients undergoing a CoreValve transcatheter aortic valve implantation procedure require a PPM within 30 days. Periprocedural atrioventricular block, balloon predilatation, use of the larger CoreValve prosthesis, increased interventricular septum diameter and prolonged QRS duration were associated with the need for PPM. (Circulation. 2011;123:951-960.)Key Words: aortic stenosis Ⅲ electrocardiography Ⅲ pacemakers Ⅲ transcatheter aortic valve Ⅲ transcatheter aortic valve implantation A ortic stenosis (AS) is the most common valvular disease in Europe, 1,2 and age is a significant factor in its natural history. 2 Severe AS occurs in 2% to 4% of adults Ͼ65 years of age. 3,4 Current guidelines recommend aortic valve replacement (AVR) surgery for these patients when they become symptomatic or develop impaired left ventricular systolic function with an ejection fraction Ͻ50%. 5,6 However, the aging population generates greater numbers of patients with severe AS and significant comorbidities, 3 prohibitively raising their perioperative risks for surgical AVR. Since the first successful implant in 2002,7 transcatheter aortic valve implantation (TAVI) has become an increasingly common technology in this cohort. The initial surveillance has been encouraging with respect to procedural success, improvement in quality of life, and short-term and medium-term mortality. 8 -10 Clinical Perspective on p 960Aortic valvular disease is itself associated with cond...
TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
BackgroundRecent recommendations suggest that in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and coexistent significant coronary artery disease, the latter should be treated before the index procedure; however, the evidence basis for such an approach remains limited. We performed a systematic review and meta‐analysis to study the clinical outcomes of patients with coronary artery disease who did or did not undergo revascularization prior to transcatheter aortic valve implantation.Methods and ResultsWe conducted a search of Medline and Embase to identify studies evaluating patients who underwent transcatheter aortic valve implantation with or without percutaneous coronary intervention. Random‐effects meta‐analyses with the inverse variance method were used to estimate the rate and risk of adverse outcomes. Nine studies involving 3858 participants were included in the meta‐analysis. Patients who underwent revascularization with percutaneous coronary intervention had a higher rate of major vascular complications (odd ratio [OR]: 1.86; 95% confidence interval [CI], 1.33–2.60; P=0.0003) and higher 30‐day mortality (OR: 1.42; 95% CI, 1.08–1.87; P=0.01). There were no differences in effect estimates for 30‐day cardiovascular mortality (OR: 1.03; 95% CI, 0.35–2.99), myocardial infarction (OR: 0.86; 95% CI, 0.14–5.28), acute kidney injury (OR: 0.89; 95% CI, 0.42–1.88), stroke (OR: 1.07; 95% CI, 0.38–2.97), or 1‐year mortality (OR: 1.05; 95% CI, 0.71–1.56). The timing of percutaneous coronary intervention (same setting versus a priori) did not negatively influence outcomes.ConclusionsOur analysis suggests that revascularization before transcatheter aortic valve implantation confers no clinical advantage with respect to several patient‐important clinical outcomes and may be associated with an increased risk of major vascular complications and 30‐day mortality. In the absence of definitive evidence, careful evaluation of patients on an individual basis is of paramount importance to identify patients who might benefit from elective revascularization.
The National Institute for Health Research Health Technology Assessment programme.
Background-Postinfarction ventricular septal defect carries a grim prognosis. Surgical repair offers reasonable outcomes in patients who survive a healing phase. Percutaneous device implantation represents a potentially attractive early alternative. Methods and Results-Postinfarction ventricular septal defect closure was attempted in 53 patients from 11 centers (1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012); aged 72±11 years; 42% female). Nineteen percent had previous surgical closure. Myocardial infarction was anterior (66%) or inferior (34%). Time from myocardial infarction to closure procedure was 13 (first and third quartiles, 5-54) days. Devices were successfully implanted in 89% of patients. Major immediate complications included procedural death (3.8%) and emergency cardiac surgery (7.5%). Immediate shunt reduction was graded as complete (23%), partial (62%), or none (15%). Median length of stay after the procedure was 5.0 (2.0-9.0) days. Fifty-eight percent survived to discharge and were followed up for 395 (63-1522) days, during which time 4 additional patients died (7.5%).
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