Joanne Shannon

Transcatheter vs surgical aortic valve replacement in intermediate- surgical-risk patients with aortic stenosis: A propensity score-matched case-control study

BACKGROUND Limited real-world data comparing outcomes after transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with aortic stenosis are available. METHODS We identified 182 consecutive patients who underwent TAVR via the transfemoral (TF) route (November 2007-February 2011) and 111 moderate-to-high-risk historical case controls undergoing SAVR (August 2003-July 2008). Using propensity score matching based on clinical characteristics and surgical risk scores, we compared clinical outcomes in 111 matched patients. Valve Academic Research Consortium definitions were applied for end point adjudication. RESULTS Baseline clinical characteristics, in particular Logistic European System for Cardiac Operative Risk Evaluation (23.2 ± 15.1 vs 24.4 ± 13.4) and Society of Thoracic Surgeons score (4.6 ± 2.3 vs 4.6 ± 2.6), were well matched between groups. Transfemoral TAVR was associated with more vascular complications (33.3% vs 0.9%, P < .001). On the other hand, acute kidney injury was more frequent after SAVR (8.1% vs 26.1%, P < .001). The rates of all-cause mortality in both TF-TAVR and SAVR groups was1.8% at 30 days (P = 1.00) and 6.4% and 8.1%, respectively, at 1 year (P = .80). At 1 year, the rate of cerebrovascular events was similar in the 2 groups (4.6% vs 9.1%, P = .19). CONCLUSIONS In this real-world cohort of intermediate-surgical-risk patients with aortic stenosis, TF-TAVR and SAVR were associated with similar mortality rates during follow-up but with a different spectrum of periprocedural complications. Furthermore, the survival rate after TF-TAVR in this group of elderly patients with intermediate Society of Thoracic Surgeons score was encouraging.

Transcatheter valve-in-valve implantation with the Edwards Sapien in patients with bioprosthetic heart valve failure: The Milan experience

AIMS Reoperation for bioprosthetic heart valve failure is associated with significant morbidity and mortality, particularly in high-risk patients. Transcatheter valve-in-valve (VIV) implantation may offer a less invasive alternative. The aim of this study was to report our initial experience with transcatheter VIV implantation to treat degenerated tissue valves. METHODS AND RESULTS VIV implantation with the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifesciences Inc, Irvine, CA, USA) was performed in 18 high-risk patients (STS 8.2±5.2%; logistic EuroSCORE 37.4±20.8%) with symptomatic bioprosthetic failure (17 aortic, one mitral). Valve Academic Research Consortium (VARC) definitions were applied for endpoint adjudication. Transfemoral access was the preferred vascular approach (16 patients, with the mitral VIV delivered anterogradely through the femoral vein; one transaxillary and one transapical). The majority (83%) of procedures were performed under local anaesthesia and sedation. Device success was achieved in all but one patient who had a final transaortic gradient ≥20mmHg. Acute kidney injury occurred in three patients (Stage 3 in 1), life-threatening or major bleeding in four patients, while major vascular complications occurred in one patient. Permanent pacemaker implantation was required in two patients. There were no deaths or neurological events at 30-day follow-up. At a median follow-up of 11 months (interquartile range 6-16), the mortality rate was 5.6% and all patients were in NYHA class II or lower. CONCLUSIONS Transcatheter implantation of the Edwards THV within a degenerated aortic bioprosthesis, performed predominantly via the transfemoral route, is feasible and associated with good periprocedural and clinical outcomes in high-risk surgical patients.

Clinical and Procedural Predictors of Suboptimal Outcome After the Treatment of Drug-Eluting Stent Restenosis in the Unprotected Distal Left Main Stem The Milan and New-Tokyo (MITO) Registry

Background— Few data are available regarding the optimal revascularization strategy for unprotected distal left main coronary artery (UDLM) in-stent restenosis (ISR). Methods and Results— Between April 2002 and December 2008, UDLM-ISR following drug-eluting stent (DES) implantation occurred in 92 of 474 patients (19.4%). Of these, 8 (8.7%) who underwent a coronary artery bypass graft (CABG) were excluded, and the remaining 84 (91.3%) who underwent percutaneous coronary intervention (PCI) (43 plain old balloon angioplasty [POBA] and 41 DES) were analyzed to assess the feasibility of PCI for UDLM-ISR. The overall cardiac death, myocardial infarction (MI), and major adverse cardiac events during the follow-up period (median, 24 months) occurred in 4, 2, and 31 patients, respectively. Repeat target lesion revascularization (TLR) occurred in 28 patients. The incidence of repeat TLR was higher following PCI with POBA than with DES (hazard ratio [HR], 2.79; 95% CI, 1.23–6.34; P=0.014). On Cox regression analysis, the independent predictors of repeat TLR were treatment with POBA (HR, 3.29; 95% CI, 1.41–7.69; P=0.006) and EuroSCORE (European System for Cardiac Operative Risk Evaluation) >6 (HR, 2.53; 95% CI, 1.02–6.28; P=0.045). More complex lesions requiring a 2-stent strategy were associated with a higher occurrence of TLR for restenosis of the left circumflex coronary artery ostium (LCX-ISR) (HR, 2.51; 95% CI, 1.59–3.97; P=0.001) as well as repeat TLR for recurrent LCX-ISR (HR, 4.32; 95% CI, 0.97–19.20; P=0.05) compared to a 1-stent strategy. No cardiac death at 2 years occurred in patients with LCX-ISR. Conclusions— UDLM restenosis is better treated with DES than with POBA. The rate of recurrent ISR following repeat PCI was high, whereas the rates of MI and death were relatively low. Complex lesions requiring a 2-stent strategy had a higher recurrence rate at the ostial LCX but without an associated increased risk of MI and death.

Impact of residual chronic total occlusion of right coronary artery on the long-term outcome in patients treated for unprotected left main disease: the Milan and New-Tokyo registry.

Background—The presence of chronic total occlusion of the right coronary artery (CTO-RCA) in patients undergoing percutaneous interventions for unprotected left main (ULM) disease may affect the prognosis. In this study, we evaluated the immediate results and follow-up of patients with ULM-percutaneous interventions and with or without associated CTO-RCA. Methods and Results—Between March 2002 and December 2008, a total of 568 consecutive patients with ULM stenosis treated with drug-eluting stent were included in this analysis. The mean EuroScore and SYNTAX scores were 4.05±2.62 and 28.12±10.82, respectively. Of these, 522 had ULM lesions without residual CTO-RCA (493 ULM without CTO-RCA+29 ULM with treated CTO-RCA), and 46 patients had residual CTO-RCA. At 1466 days (interquartile range, 1150–1917) follow-up, the cardiac-death occurred in 41 patients (7.2%). Cardiac-death was more frequently observed in patients with ULM and residual CTO-RCA as compared with those without residual CTO-RCA (adjusted hazard ratios, 2.163 [95% confidence interval, 1.018–4.597]; P=0.045). However, target lesion revascularization occurred less frequently in patients with residual CTO-RCA (adjusted hazard ratios, 0.321 [95% confidence interval, 0.13–0.794]; P=0.014), resulting in the similar major adverse cardiovascular events rates between the 2 groups. When we analyzed patients with concomitant ULM and CTO-RCA, cardiac-death was significantly higher in patients with residual as compared with treated CTO-RCA (log-rank P=0.01) despite no difference in baseline characteristics. Conclusions—Cardiac-death occurred more frequently in patients with residual CTO-RCA as compared with those without residual CTO-RCA. These findings suggest that recanalization of CTO-RCA has significant impact on the long-term cardiac-mortality in patients undergoing ULM-percutaneous interventions probably by offering reserve coronary circulation, if in-stent restenosis were to occur in the treated left main.

Procedural trauma risks longitudinal shortening of the Promus Element™ stent platform.

This case series raises further awareness of the potential for longitudinal shortening with the Promus Element™ (Boston Scientific, MN) drug‐eluting stent (DES) platform. With safety at the forefront of DES development, newer generation systems are utilizing thinner platforms with little or no polymer. Although these contemporary, ultrathin platforms also improve conformability and deliverability, specific design characteristics might inadvertently reduce longitudinal strength. To date, there are no randomized data addressing this issue in vivo for any stent platform, with opinion based on individual experience and bench testing. We report five cases of longitudinal shortening with the Promus Element stent occurring in our institution over a 15‐month period. During the same period, we experienced only isolated cases with other second generation DES platforms. Our experience supports recently published bench‐top data correlating the two‐link design of this platform with the risk of compression.

Hybrid Procedures Have Proven Clinical Utility and Are the Wave of the Future

The optimal revascularization strategy for multivessel coronary artery disease remains controversial, especially when there is diffuse disease involving the proximal segment of the left anterior descending artery (LAD). Coronary artery bypass graft surgery (CABG) remains the gold standard approach, although the evidence is increasingly being challenged by technological and procedural advances in percutaneous coronary intervention (PCI). The well-established survival benefit of surgery1–3 is conferred by the left internal mammary arterial (LIMA) graft to the LAD, which, through its resistance to thrombosis and atherosclerosis,4 has demonstrated patency rates of 95% to 98% at 10 years.5,6 Moreover, the LIMA has been shown to protect the proximal LAD territory against further ischemic injury from progressive disease.4 However, the incremental benefit of concomitant saphenous vein grafts (SVGs) supplying non-LAD territories is less clear.2,3 The longevity of vein grafts is relatively poor, with reported failure rates averaging 20% at 1 year and reaching up to 70% at 15 years.6–8 Interestingly, the Project of Ex-vivo Vein graft Engineering via Transfection IV (PREVENT IV) trial investigators reported an SVG failure rate of 45% at 12- to 18-month angiographic follow-up,7 a figure that, in the modern era, seems unacceptable. Response by Leacche et al on p 2503 So, is CABG a double-edged sword? It certainly seems plausible that the prognostic benefit conferred by the longevity of the LIMA-to-LAD graft might, in some way, be offset by the disappointing survival rates of SVG to non-LAD vessels. Although vein graft occlusion is certainly as frequent as stent thrombosis,9 stent thrombosis is characteristically associated with a higher incidence of major adverse cardiac events. Vein graft narrowing, in contrast, is at least 2 or 3 times more frequent than stent restenosis, although both tend to be …

Recognition and management of complications during transcatheter aortic valve implantation.

In the field of interventional cardiology, transcatheter aortic valve implantation is the newest and most exciting development of recent years. With a growing evidence base for both prognostic and symptomatic benefit, more and more interventionalists are keen to learn the procedure. However, the concomitant risk associated with a technically challenging procedure in a high-risk patient population is significant, and complications can arise suddenly and often unexpectedly. It is essential that new, and even established, operators are meticulously aware of the potential for complications, are able to identify them at an early stage, and manage them quickly and effectively. We have significant experience with transcatheter aortic valve implantation, through the implantation of 260 devices, which brings first-hand experience of most major complications. This article provides insight into the potential for complications, offering advice on effective treatment, recognition, and ultimately, prevention. It also suggests a number of procedural and technical modifications, which might improve outcomes in the future.

Drug-Eluting Balloon in the Treatment of In-Stent Restenosis and Diffuse Coronary Artery Disease: Real-World Experience from Our Registry

OBJECTIVES To report a single-center experience of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease. BACKGROUND DEB are emerging as an alternative treatment for coronary stenosis especially when metal scaffolding is undesirable (in-stent restenosis and small-vessel de novo disease). Although there are various randomized trials and registry studies, the data from real-world cohorts are lacking. METHODS Consecutive patients treated with the In.Pact Falcon™ (Medtronic Inc., Minneapolis, MN, USA) paclitaxel-eluting balloon between January 2009 and December 2011 were retrospectively studied. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TVR. RESULTS A total of 275 lesions were successfully treated in 184 patients. The mean age was 66.2 ± 9.6 years, and 87% were males. The predominant indication for DEB use was ISR (62%), with de novo lesions accounting for the remainder (38%). A mean of 1.48 ± 0.9 DEB were used per patient. Bailout stenting was required in 24% of lesions. The median clinical follow-up was 14.6 months (IQR 12-23). The overall rates of cardiac death, MI, TLR, TVR, and MACE were 3.8%, 1.6%, 16.8%, 17.9%, and 21.7%, respectively. The overall rate of stent thrombosis was 0.5% (n = 1). CONCLUSION Our results suggests that DEB can be considered in lesions where the use of stents is not desirable, especially restenotic lesions. Further long-term follow-up of these patients will provide us more insights on the long-term outcomes.

The impact of main branch restenosis on long term mortality following drug-eluting stent implantation in patients with de novo unprotected distal left main bifurcation coronary lesions: the Milan and New-Tokyo (MITO) Registry.

In‐stent restenosis (ISR) remains one of the main limitations for percutaneous coronary intervention of unprotected distal left main (UDLM). This study aims to demonstrate the impact of main‐branch ISR (MB‐ISR) on mortality and to clarify the optimal strategy.

Revascularization in multivessel CAD: a functional approach.

The primary objective of invasive treatment strategies for multivessel coronary artery disease is complete anatomical revascularization—traditionally considered the strongest predictor of improved clinical outcome in this setting. This concept, however, is being challenged by evidence suggesting that addressing ischemia is the key to reducing mortality, myocardial infarction, and life-limiting angina. As objective evidence of ischemia can be provided by a functional assessment on the basis of fractional flow reserve, the focus of contemporary treatment should arguably shift from anatomical to functional revascularization. Moreover, the decision to revascularize specific lesions should be made after consideration of the degree of myocardial viability, ischemic burden, overall clinical risk, and technical feasibility. Most importantly, however, the revascularization strategy should be tailored to the individual patient and the expertise of the institution, and use contemporary techniques combined with modern pharmacotherapy. This Perspectives article summarizes the data supporting contemporary functional revascularization and its applicability to real-world practice.