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.

BACKGROUND: 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. METHODS: Between 2002 and 2008, 482 consecutive UDLM patients treated with drug eluting stent (sirolimus and paclitaxel) were evaluated. RESULTS: During follow-up period (median 52.6 months), MB-ISR occurred in 29, SB-ISR in 65, and MB/SB-ISR in 24. Multivariable analysis demonstrated that the independent predictors of MB-ISR were calcification (HR 2.284, p = 0.016), true-bifurcation (HR 2.331, p = 0.024), insulin-dependent diabetes mellitus (insulin-DM) (HR 2.259, p = 0.048). Furthermore, final proximal postdilatation (FPPD) (HR 0.548, p = 0.077), full LM cover approach (FCA) (HR 0.605, p = 0.093) and greater MLD (HR 0.611, p = 0.062) had a tendency to reduce MB-ISR. Furthermore, the occurrence of MB-ISR within 1-year was associated with cardiac-death (HR 2.734, p = 0.017). CONCLUSIONS: The patients with MB-ISR had more comorbidities and complex lesions, resulting in higher risk of cardiac mortality as compared to the patients without MB-ISR. Presence of calcification, true-bifurcation and insulin-DM were associated with MB-ISR following UDLM intervention, while FCA, FPPD, and greater MLD seemed to be associated with the low occurrence of MB-ISR.

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.

"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.

Midterm Outcomes in Patients With Aortic Stenosis Treated With Contemporary Balloon-Expandable and Self-Expanding Valves: Does Valve Size Have an Impact on Outcome?

Background No data currently exist comparing the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results In this retrospective registry, periprocedural outcomes and midterm all-cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years (Plog-rank=0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3±8 mm Hg SE versus 21.9±8 mm Hg BE) and mean (8.8±5 mm Hg SE versus 11.5±5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P<0.001). In patients treated with small transcatheter heart valves (≤26 mm for SE and ≤23 mm for BE; N=284 for SE and N=260 for BE), survival was higher among patients treated with SE valves at both 1 (96.7% SE versus 92.1% BE) and 3 (91.8% SE versus 82.2% BE) years (Plog-rank=0.042). In propensity-matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), Plog-rank=0.096). Conclusions Real-world comparison of the latest-generation SE and BE devices demonstrated similar survival up to 3 years' follow-up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.

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.

Iatrogenic perforation of the medial circumflex artery following femoral venous cannulation for transcatheter aortic valve replacement, presenting with retroperitoneal hematoma and successfully managed by percutaneous embolization and coiling.

Vascular complications are a major concern during transcatheter aortic valve replacement and can occur independently of introducer size. Arterial and venous access must be meticulous to avoid potentially life-threatening bleeding, which most commonly results from injury to the common femoral or iliac arteries. We report an unusual case of perforation of the medial circumflex branch of the common femoral artery resulting from attempted femoral venous cannulation. Injury to this vessel is characteristically associated with silent retroperitoneal extravasation and is notoriously difficult to recognize and treat. Despite identification of the perforation on contrast-enhanced computed tomography, the anatomical site could only be localized to the medial circumflex branch on highly selective contrast angiography. Thereafter, it was successfully treated percutaneously by embolization and coiling.

Effect of the COVID-19 pandemic on ST-elevation myocardial infarction presentation and survival.

Presentation and outcomes of patients with ST-elevation myocardial infarction (STEMI) may change during viral pandemics. We compared symptom-tocall (STC), call-to-balloon (CTB), doorto-balloon (DTB) times; high-sensitivity troponin (hs-cTnI) levels; and survival of patients (n=39) during the first wave of the COVID-19 pandemic (defined as a 'COVID period' starting four weeks before lockdown) to historical controls from a 'pre-COVID period' (n=45). STEMI admissions fell one week before lockdown by 29%. Median STC times began to rise one month before lockdown (54 vs. 25 min, p=0.06), with peak increases between 9 March and 5 April (166 vs. 59 min, p=0.04). Median CTB and DTB times were unchanged. Mean peak hs-cTnI increased during COVID-19 (15,225 vs. 8,852 ng/ml, p=0.004). Six-month survival following all STEMI reduced (82.1% vs. 95.6%, p<0.05). STC times are the earliest indicator that STEMI-patient behaviour changed four weeks before lockdown, correlating with higher troponin levels and reduced survival. These early signals could guide public health interventions during future pandemics.

Differences in airway cytokine profile in severe asthma compared to moderate asthma.

BACKGROUND: Some studies of severe asthma suggest that persistence or alteration in the pattern of inflammation may be associated with the severity of the disease. Whether there are differences in the expression of the principal cytokines and chemokines relevant to eosinophilic and neutrophilic inflammation in the airway tissues of severe compared to moderate asthmatics has not been determined. The aim of this study was to compare the patterns of expression of representative T-helper (Th) type 1 (interferon [IFN]-gamma) and Th-2 cytokines (interleukin [IL]-4, IL-5) and the neutrophil- and eosinophil-associated chemokines (IL-8 and eotaxin) in the airway tissues of patients with severe and moderate asthma. METHODS: Subjects with severe asthma (n = 24) and a comparison moderate asthma group (n = 26) were assessed using spirometry, induced sputum, exhaled nitric oxide, and bronchial biopsy. The expression of proteins of interest in the epithelium and subepithelium of the airway wall was examined by immunocytochemistry. RESULTS: Subjects with severe asthma were more symptomatic, had a lower FEV(1), and had more sputum neutrophilia (p = 0.007) and eosinophilia (p = 0.001). Exhaled nitric oxide was similar between groups. IL-8 and IFN-gamma expression were increased and IL-4 expression was decreased in severe asthma compared to moderate disease (p < 0.001 for each comparison). Eotaxin and IL-5 expression did not differ between the groups. CONCLUSION: Patients with severe asthma have increases in neutrophils and eosinophils in the sputum, and differ in airway cytokine/chemokine expression from moderate asthmatics. Excess neutrophilia may be explained by increased expression of IL-8, but differences in eosinophilia do not appear to be associated with IL-5 and eotaxin expression.

An early phase of slow myocardial activation may be necessary in order to benefit from cardiac resynchronization therapy.

BACKGROUND: Not all patients with a QRS duration longer than 140 milliseconds respond to cardiac resynchronization therapy (CRT). The same QRS duration may correspond to different spatiotemporal patterns of myocardial activation that influence response to CRT. METHODS: Electrocardiographic imaging based on 80 chest wall electrodes was used to construct the spatiotemporal myocardial activation map in 46 consecutive patients before CRT. The cumulative percentage of myocardium activated was plotted against time expressed in terms of quintiles of the overall QRS duration. Changes in the left ventricular ejection fraction and end-diastolic diameter, maximum oxygen consumption per minute, brain natriuretic peptide level, and 6-minute walk distance after 6 months of CRT were compared across different patterns with 1-way analysis of variance. RESULTS: Data from 34 patients were available for analysis. Four spatiotemporal patterns of myocardial activation could be identified: triphasic (fast-slow-fast) (13), uniform (8), fast-slow (7), and slow-fast (6). The overall QRS duration was similar in the 4 groups (166 +/- 19 vs 138 +/- 21 vs 157 +/- 26 vs 152 +/- 37 milliseconds, P = not significant [NS]). The ejection fraction showed a trend of greater increases for the triphasic (6.5% +/- 7.0%) and slow-fast (15.5% +/- 6.4%) patterns than for the uniform (4.0% +/- 13.3%) and fast-slow (8.0% +/- 6.1%) patterns (P = NS). The end-diastolic diameter showed a trend of greater decreases for the triphasic (-3.7% +/- 5.3%) and slow-fast (-7.0% +/- 6.7%) patterns than for the uniform (0.8% +/- 6.7%) and fast-slow (0.0% +/- 4.6%) patterns (P = NS). The maximum oxygen consumption per minute showed a trend of greater increases for the triphasic (1.2 +/- 4.2 mL/kg/min) and slow-fast (4.1 +/- 2.7 mL/kg/min) patterns than for the uniform (0.1 +/- 4.1 mL/kg/min) and fast-slow (1.0 +/- 2.1 mL/kg/min) patterns (P = NS). The brain natriuretic peptide level decreased significantly more for the triphasic (-450 +/- 1269) and slow-fast (-3121 +/- 1512) patterns than for the uniform (762 +/- 1036) and fast-slow (718 +/- 2530) patterns (P = .0003). The 6-minute walk distance increased significantly more for the triphasic (29 +/- 89) and slow-fast (40 +/- 23) patterns than for the uniform (6 +/- 87) and fast-slow (37 +/- 45) patterns (P = .0003). CONCLUSIONS: Different spatiotemporal patterns of myocardial activation exist among patients with broad QRS complex and may affect response to CRT. An early phase of slow myocardial activation (the triphasic fast-slow-fast and the slow-fast patterns) may be necessary for a patient to benefit from CRT.

FFR result post PCI is suboptimal in long diffuse coronary artery disease.

AIMS: The aim of this study was to evaluate the functional result immediately post PCI and at nine-month follow-up, and to ascertain how often a functionally optimal result of >0.95 can be achieved in long coronary lesions treated with long second- or newer-generation DES. METHODS AND RESULTS: Patients receiving DES measuring ≥30 mm with FFR value ≤0.8 were included in the study. Stent length was defined as long (30 to 49 mm; L-DES) and ultra-long (≥50 mm; UL-DES). Angiographic and FFR evaluation was performed before and after PCI and at nine-month follow-up. A total of 74 patients each received a mean stent length of 50.72±14.6 mm. Mean FFR post PCI was 0.88±0.06. An optimal post PCI FFR value of >0.95 was achieved in only 9/74 patients (12.2%), and was not achieved in any UL-DES patients. Only 12/74 (16.2%) had FFR post PCI of 0.91 to 0.95; 8/74 (10.8%) patients remained ischaemic (≤0.8). FFR gradient across the stent was higher in UL-DES patients compared to L-DES patients (0.07±0.03 vs. 0.04±0.03; p=0.001). At follow-up, the angiographic restenosis rate was 4.7%, and the functional restenosis rate was 15.1%. CONCLUSIONS: The FFR result post PCI was suboptimal in the majority of patients treated with long DES and was particularly poor when the total stent length exceeded 50 mm.

Impact of gender on long-term mortality in patients with unprotected left main disease: The Milan and New-Tokyo (MITO) Registry.

BACKGROUND: Although percutaneous intervention (PCI) for ULM is common, the impact of gender remains unclear. This study aimed to clarify the impact of gender in patients treated with drug-eluting stents (DES) for unprotected left main (ULM) disease. METHODS: Between April 2002 and August 2011, 1026 consecutive patients (212 women and 814 men) undergoing PCI using first or second generation DES for ULM stenosis were analyzed. Study endpoints included major adverse cardiac events (MACE) defined as composite of all-cause death, myocardial infarction (MI), and target lesion revascularization (TLR). Individual components of MACE and cardiac death were also evaluated. RESULTS: Women had greater comorbidity and more complex lesions, resulting in a higher incidence of cardiac death, TLR and MI {[HR, 1.94 (95% CI, 1.22-3.09, p=0.005)], [HR, 1.31 (95% CI 0.96-1.81), p=0.09] and [HR, 2.04 (95% CI, 0.98-4.25), p=0.06], respectively}. Propensity score matching identified 131 matched pairs. There were no differences in MACE [HR, 1.04 (95% CI, 0.68-1.61, p=0.85)], all-cause death [HR, 0.96 (95% CI, 0.52-1.77), p=0.89] or MI [HR, 0.84 (95% CI, 0.21-3.50, p=0.84)]. However, cardiac death [HR, 2.70 (95% CI, 0.98-7.49, p=0.056] and TLR [HR, 1.62 (95% CI, 0.93-2.84), p=0.09] showed a trend to being higher in women compared to men. CONCLUSIONS: In patients with ULM disease, women had greater comorbidity and more complex lesions, resulting in an increased risk of clinical events. However after propensity matching, there was no difference in the occurrence of MACE but cardiac death showed a trend to being higher in women compared to men.

Discrepancies in vessel sizing between angiography and intravascular ultrasound varies according to the vessel evaluated.

BACKGROUND/OBJECTIVES: Quantitative coronary analysis (QCA) of the coronary artery and stent size may be influenced by anatomical location in relation to both calibration point and the X-ray tube. The impact of this phenomenon on lesion assessment is undetermined. METHODS: In total, 427 consecutive patients who underwent PCI with intravascular ultrasound (IVUS)-guidance were enrolled. The minimum stent diameter (MSD) was measured using QCA (MSDQCA) and IVUS (MSDIVUS) analysis. We used reference objects positioned at a different height from the X-ray source to validate our approach. RESULTS: A statistically positive moderate correlation was observed between MSDQCA and MSDIVUS (r=0.649, p=0.001). The mean MSDQCA and MSDIVUS were 3.04±0.49 mm and 2.68±0.47 mm respectively. The difference between MSDQCA and MSDIVUS of >0.75 mm was more frequently observed in the LCx rather than in the LAD (7.4% in the LAD vs. 24.3% in the LCx, p=0.001). The discrepancy between the MSDQCA and MSDIVUS for the LCx was larger than for the LAD, and tended to be larger than for the RCA (13.3% vs. 18.5%, p=0.05 and 18.5% vs. 14.5%, p=0.17). A discrepancy >20% was more frequently observed in the small (≤2.5 mm) than in the large MSDIVUS group (52.7% vs. 25.1%, p=0.001). This discrepancy was more common in the LCx than in the LAD or RCA (48.6% vs. 30.9% vs. 31.2%, p=0.03). CONCLUSIONS: Assessment of the MSDQCA is more likely to overestimate in the LCx than in the LAD, particularly when the MSDIVUS is <2.5 mm. Therefore, we should be less aggressive in oversizing balloons and stents based on QCA for the LCx or small vessel intervention.

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.

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.

Incidence of overall bleeding in patients treated with intra-aortic balloon pump during percutaneous coronary intervention: 12-year Milan experience.

OBJECTIVES: This study aims to report a "real-world" experience of in hospital complications and clinical outcome of a large cohort of consecutive patients who underwent percutaneous coronary intervention (PCI) with intra-aortic balloon pump counterpulsation (IABP) support, from a tertiary care center over a 12-year period. BACKGROUND: The incidence of vascular complications in patients treated with PCI and IABP is expected to be higher due to simultaneous puncture of femoral arteries, larger IABP sheath size, and longer duration of IABP therapy. METHODS: A total of 360 consecutive patients (mean age of 65.9 ± 11.2 years; 80.6% male) who required an IABP support during percutaneous PCI were classified into 3 groups: Urgent: 133 patients (36.9%) admitted with acute coronary syndrome in whom IABP therapy was started before urgent PCI; Emergent: 56 patients (15.6%) in whom emergent IABP insertion was required to manage hypotension during PCI; and Elective: 171 patients (47.5%) with stable angina pectoris in whom IABP was inserted before elective PCI. Overall bleeding was defined according to the newest the Bleeding Academic Research Consortium (BARC) definition criteria. RESULTS: BARC bleeding occurred in 68 patients (19%), with the highest incidence noted in the Urgent group (31.1%), in comparison with the Emergent (26.8%) and Elective (7%) groups, p < 0.0001. Bleeding related to the IABP access site was 7.5%, which accounted for 82% of any access site-related bleeding. It was significantly higher in the Urgent group (12.8%) compared with the Elective (4.1%) and Emergent (5.4%) groups. At multivariate analysis, IABP treatment duration and renal impairment were the only independent predictors of BARC bleeding. CONCLUSIONS: Bleeding related to the IABP access site was significantly higher in the Urgent group and accounted for more than two-thirds of overall access site-related bleeding. IABP treatment duration and renal impairment were independent predictors of overall bleeding.

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.

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.

The inverse problem utilizing the boundary element method for a nonstandard female torso.

This paper proposes a new method of rapidly deriving the transfer matrix for the boundary element method (BEM) forward problem from a tailored female torso geometry in the clinical setting. The method allows rapid calculation of epicardial potentials (EP) from body surface potentials (BSP). The use of EPs in previous studies has been shown to improve the successful detection of the life-threatening cardiac condition--acute myocardial infarction. The MRI scanning of a cardiac patient in the clinical setting is not practical and other methods are required to accurately deduce torso geometries for calculation of the transfer matrix. The new method allows the noninvasive calculation of tailored torso geometries from a standard female torso and five measurements taken from the body surface of a patient. This scaling of the torso has been successfully validated by carrying out EP calculations on 40 scaled torsos and ten female subjects. It utilizes the BEM in the calculation of the transfer matrix as the BEM depends only upon the topology of the surfaces of the torso and the heart, the former can now be accurately deduced, leaving only the latter geometry as an unknown.

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.