Percutaneous treatment of abdominal aortic aneurysm and aortic valve stenosis with 'staged' EVAR and TAVR: a case series.

Symptomatic aortic valve stenosis (AS) and abdominal aortic aneurysm (AAA) are critical clinical conditions, increasingly more prevalent with aging of the population. Calcific aortic stenosis is the most common structural cardiac disease in the elderly population, and medical management of severe aortic stenosis of the elderly population is associated with poor outcomes as compared to surgical treatment. Transcatheter aortic valve replacement (TAVR) is a treatment of choice in inoperable, often elderly, patients with symptomatic severe AS and in intermediate-to-high surgical risk patients. It is not yet clarified the incidence of AAA and its impact on procedural and clinical outcomes among patients undergoing TAVR. It is known that after AS resolution with aortic valve replacement or TAVR there is an increase in blood pressure that increases the risk of dissection or abdominal aortic aneurysm rupture if AAA repair is delayed. The purpose of this report is to describe the anatomical details and technical and procedural considerations when proposing totally endovascular strategies dedicated to the treatment of patients with AS and AAA.

Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial.

BACKGROUND: Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes. OBJECTIVES: The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex. METHODS: EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age. RESULTS: Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints. CONCLUSIONS: At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).

Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study.

AIMS: Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. METHODS: One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. RESULTS: A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. CONCLUSION: Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).

Assessing the Impact of Transcatheter Aortic Valve Implantation on Cardiac Catheterisation: A Multicentric Study.

BACKGROUND: The success rate of coronary angiography (CA) after transcatheter aortic valve implantation (TAVI) is variable. Our aim was to investigate CA difficulty, outcomes, and predictors of difficult CA after TAVI. METHOD: This was an international multicentric retrospective cohort study that included patients with TAVI and subsequent CA between January 2010 and December 2019. Difficulty with CA was graded as 1 (normal), 2 (partial engagement, complete vessel opacification), 3 (partial engagement, incomplete vessel opacification), and 4 (unsuccessful angiography). Patients were grouped as (a) "easy" (grade 1 for left and right) or (b) "difficult" (grade >1 for either). We compared baseline characteristics and outcomes, and performed multivariate logistic regression for predictors of difficult CA. RESULTS: Of 96 patients included (mean age 77.4±8.7 years, 48 [50%] male), 88 (92%) had successful CA. Right CA was successful in 80 (83%) patients and left CA in 91 (95%) (p<0.0001). The "difficult" group (n=41 [43%]) had higher Society of Thoracic Surgery (STS) scores (7.6±4.9 vs 5.4±4.0; p=0.022), smaller annulus perimeters (72.4±5.4 mm vs 76.2±9.4 mm; p=0.049), greater use of self-expanding valves (83% vs 18%; p<0.0001), increased valve size (26.8±2.1 mm vs 25.6±3.0 mm; p=0.032), and increased oversizing for area (44.3%±17.4% vs 23.6%±22.0%; p=0.0002) and perimeter (17.5%±8.2% vs 7.1%±10.8%; p<0.0001). There was no difference in outcomes except for increased major bleeding (7.3% vs 0.0%; p=0.042). The strongest predictor for "difficult" CA was self-expanding valves when compared to balloon-expandable valves (adjusted odds ratio [aOR], 15.23; 95% confidence interval [CI], 2.27-102.40). Society of Thoracic Surgery score was borderline predictive (aOR, 1.26; 95% CI, 1.04-1.52). CONCLUSIONS: Our results show that after TAVI, CA success rate is high, right CA is more difficult than left, self-expanding valves predispose to difficult CA, and STS score weakly predicts difficult CA. This study is hypothesis-generating and more research is required to confirm these findings.

Comparing the Safety and Effectiveness of Five Leading New-Generation Devices for Transcatheter Aortic Valve Implantation: Twelve-Month Results From the RISPEVA Study.

OBJECTIVES: The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices. METHODS: We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs). RESULTS: A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05). CONCLUSION: Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up.

Impella 5.0 supported oncological surgery as bridge to LVAD.

We describe the case of a 58-year-old man presenting with myocardial infarction complicated by cardiogenic shock, treated with Impella CP which was escalated to an axillary 5.0 due to lack of cardiac recovery. Weaning from Impella 5.0 failed, and the patient was evaluated for heart transplantation (HTx) or left ventricular assist device (LVAD). HTx was excluded because of a rectal adenocarcinoma. The patient underwent colorectal surgery while on Impella. Perioperative course was uneventful. After 61 days of Impella, when the LVAD implantation was scheduled, the patient died due to K. pneumoniae infection.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. RESULTS: 82 patients (5%) were discharged with ≤3-month DAPT (57 ±â€¯27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ±â€¯75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). CONCLUSIONS: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

Pulmonary embolism with migrating thrombus through patent foramen ovale: A case for a mixed pharmacological and percutaneous management.

A 61-year-old man, admitted to our hospital for bilateral pulmonary embolism, complicated by right renal ischemia and multiple splenic infarcts due to a mobile thrombus entrapped in a patent foramen ovale, has been successfully treated with apixaban 5 mg twice daily followed by transcatheter patent foramen ovale closure. .

Long-term follow-up of total arterial versus conventional and hybrid myocardial revascularization: A propensity score matched analysis.

PURPOSE: To evaluate the impact of the revascularization technique (by means of conventional, total arterial or hybrid myocardial revascularization) in patients with multivessel coronary artery disease. METHODS: A propensity-score analysis of patients undergoing myocardial revascularization from 1998 to 2012 was performed based on the surgical technique utilized, either total arterial (Group1, G1,n°â€¯= 89), conventional CABG(LIMA on LAD plus veins, Group2, G2,n°â€¯= 89), or hybrid revascularization (LIMA on LAD plus PTCA on non-LAD vessels, Group3, G3, n°â€¯= 89). Primary end-points were overall survival and cardiac-related death while secondary composite end-point was survival freedom from major adverse cardiac and cerebrovascular events (MACCEs) defined as myocardial infarction, cardiac death, stroke and repeated target vessel revascularization. RESULTS: Study population was mostly affected by double-vessels disease (G1 = 2.35 vs G2 = 2.3 vs G3 = 2.4, p = 0.14) with a preserved LV function(G1 = 48% vs G2 = 49% vs G3 = 50%, p = 0.12). Hospital mortality was 0% in all groups. At a mean follow-up of 6 ±â€¯2 years overall survival was significantly better in patients receiving total arterial myocardial revascularization (G1 = 90.4 ±â€¯3.5% vs G2 = 82.3 ±â€¯4.2% vs G3 = 82.1 ±â€¯5.9%, p = 0.049) as well as freedom from MACCEs (G1 = 95.2 ±â€¯2.4% vs G2 = 86.5 ±â€¯4% vs G3 = 68 ±â€¯6.9%, p = 0.001) while survival free from cardiac-related death was similar(G1 = 97.7 ±â€¯1.6% vs G2 = 95.1 ±â€¯2.4% vs G3 = 89.5 ±â€¯5.4%, p = 0.08). Conversely, at 10 years follow-up only freedom from MACCEs was significantly better in patients of Group 1(G1 = 78.9 ±â€¯8.6% vs G2 = 72.4 ±â€¯5.7% vs G3 = 52 ±â€¯8.7%, p < 0.001). CONCLUSIONS: Total arterial revascularization provides improved outcomes at mid and long term follow-up compared with conventional or hybrid revascularization. The latter technique is particularly associated with a significantly higher incidence of late myocardial infarction and repeat revascularization.

A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study.

OBJECTIVES: The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention. METHODS: This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days. RESULTS: During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported. CONCLUSIONS: A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781).

A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in "real-world" patients with aortic stenosis and intermediate- to high-risk profile.

OBJECTIVE: We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate- to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation. METHODS: Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2. RESULTS: Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P< .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P< .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% ± 2.4% vs sutureless = 94.9% ± 2.1% vs transcatheter aortic valve replacement = 79.5% ± 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly better in patients undergoing surgical aortic valve replacement and sutureless valve implantation than in patients undergoing transcatheter aortic valve replacement (surgical aortic valve replacement = 92.6% ± 2.3% vs sutureless = 96% ± 1.8% vs transcatheter aortic valve replacement = 77.1% ± 4.2%; P < .001). Multivariate Cox regression analysis identified transcatheter aortic valve replacement as an independent risk factor for overall mortality hazard ratio (hazard ratio, 2.5; confidence interval, 1.1-4.2; P = .018). CONCLUSIONS: The use of transcatheter aortic valve replacement in patients with an intermediate- to high-risk profile was associated with a significantly higher incidence of perioperative complications and decreased survival at short- and mid-term when compared with conventional surgery and sutureless valve implantation.

Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Treating the patients in the 'grey-zone' with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement.

OBJECTIVES: Although the use of transcatheter aortic valve replacement (TAVR) has recently become an attractive strategy in extremely high-risk patients undergoing aortic valve replacement (AVR), the most appropriate treatment option in patients with an intermediate- to high-risk profile with conventional surgery (sAVR), TAVR or novel options, such as sutureless valves, has been widely debated. METHODS: One hundred and sixty-three consecutive patients with intermediate to high risk were prospectively enrolled and selected to undergo sAVR (Group 1: G1, n = 55), sutureless valve implantation (Group 2: G2, n = 53) or TAVR (Group 3: G3, n = 55) following a multidisciplinary evaluation including frailty, anatomy and degree of atherosclerotic disease of the aorta/peripheral vessels. The mean logistic EuroSCORE (G1 = 21.3 ± 12.7 vs G2 = 16 ± 11.7 vs G3 = 20.4 ± 12.7, P = 0.06) and preoperative demographics, such as age, gender and left ventricular ejection fraction, were similar: of note, chronic obstructive pulmonary disease was more frequent in TAVI patients (G1 = 27.2% vs G2 = 15.1% vs G3 = 47%; P <0.01). The Perceval S sutureless valve was used in Group 2, whereas TAVR was performed with a Corevalve prosthesis. RESULTS: Post-procedural pacemaker implantation (G1 = 1.8% vs G2 = 2% vs G3 = 25.5%, P <0.001) and peripheral vascular complications (G1 = 0% vs G2 = 0% vs G3 = 14.5%, P <0.001) occurred more frequently in patients undergoing TAVR. Hospital mortality was similar among the groups (G1 = 0% vs G2 = 0% vs G3 = 1.8%, P = NS). At the 24-month follow-up, overall survival free from major adverse cardiac and cerebrovascular events and prosthetic regurgitation was better in patients who had undergone sAVR and sutureless valves than those who had undergone TAVR (G1 = 95.2 ± 3.3% vs G2 = 91.6 ± 3.8% vs G3 = 70.5 ± 7.6%; P = 0.015). CONCLUSIONS: This preliminary study suggests that the use of TAVR in patients with an intermediate- to high-risk profile is associated with a higher rate of perioperative complications and decreased survival at the 24-month follow-up compared with the use of conventional surgery or sutureless valves.

Hybrid coronary revascularization in 100 patients with multivessel coronary disease.

BACKGROUND: Hybrid coronary revascularization, meaning, left mammary artery on left anterior descending artery combined with non-left anterior descending artery percutaneous coronary intervention stenting, is considered a viable alternative to conventional coronary artery bypass graft surgery or to multivessel percutaneous coronary intervention, to perform a functionally complete revascularization. METHODS: One hundred consecutive patients underwent hybrid coronary revascularization. Coronary risk was assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score. Long-term outcomes, major adverse cardiac and cerebrovascular events (MACCE) rate, and repeated target vessels revascularization (TVR) rate were evaluated. RESULTS: Mean age was 66.3±12.0 years. Mean SYNTAX score was 28.22±7. Mean European System for Cardiac Operative Risk Evaluation II score was 4.05±1.83. Percutaneous coronary intervention was performed in all patients (n=100), in 75% of cases before and in 25% of cases after surgery (interval, 2.2±1.3 months). No in-hospital mortality was reported. At follow-up, 1 cardiac death of acute MI occurred. At 3.5±1.3 years follow-up, overall population freedom from MACCE rate was 82.6% (95% confidence interval [CI]: 79.5% to 85.7%) and the freedom from TVR rate was 86.1% (95% CI: 82.9% to 89.3%). MACCE and TVR rates were higher in patients with intermediate and high coronary risk than in patients with SYNTAX score of 22 or less, although not statistically significant (p>0.05). Cox regression analysis showed a significant increment of risk for TVR on overall population in patients with diabetes mellitus (OR 2.4, 95% CI 1.3-3.5, p=0.03) and in patients with non-left anterior descending artery stented lesions (OR 4.5, with 95% CI 2.8-6.2, p=0.02). CONCLUSIONS: Hybrid coronary revascularization is a viable option to perform a minimally invasive, functionally complete revascularization in high-risk patients for conventional revascularization, with better results when performed on patients with a SYNTAX score of 22 or less.

Hybrid revascularization in multivessel coronary artery disease.

OBJECTIVES: Minimally invasive hybrid revascularization (MIHR) by means of the left mammary artery on the left anterior descending artery [minimally invasive direct coronary artery bypass (MIDCAB)] combined with percutaneous coronary interventions (PCI) stenting may be an alternative to conventional coronary artery bypass grafting through sternotomy or multiple PCI. The purpose of this study is to retrospectively evaluate the long-term outcomes of this strategy. METHODS: Since May 1997 up to January 2011, 810 MIDCAB have been performed as isolated revascularization in 644 patients. Since 2004, MIDCAB, as a part of hybrid revascularization, was associated with PCI in 166 patients. RESULTS: In the MIDCAB group, mean age was 64.6 ± 12.0, with 83.8% males. Two-vessel disease was 62.4%, three-vessel disease 37.6%. Overall mortality was 0.24%, perioperative acute myocardial infarction-1.6%, early reoperation-0.74%, reopening for bleeding-1.2%, case rate of haemotrasfusion-3.1%, with a mean hospital postoperative stay of 4 ± 2.5 days. Postoperative angiographic control prior to PCI and in symptomatic patients showed patent left internal mammary artery in 100% of cases. PCI was performed in 166 patients, 64.2% before MIDCAB and 35.8% after surgery (interval 2.2 ± 1.3 months). The mean follow-up in the MIDCAB group was 8.4 ± 3.2 years. In the MIHR group, at the mean follow-up of 4.5 ± 2.3 years, freedom from related cardiac death was 93% with freedom from cardiac reintervention of 83%. CONCLUSIONS: Our 13-year experience with MIDCAB demonstrates that the operation is safe and associated with a very low incidence of early and late complications. The hybrid approach provided excellent long-term outcome in terms of freedom from cardiac death and reoperation. Accurate patient selection, as well the timing of the hybrid procedure, is mandatory to optimize surgical and PCI results.

A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study.

OBJECTIVES: The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels. BACKGROUND: DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de novo disease. METHODS: BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicenter trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary endpoints were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. RESULTS: Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter <2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21; 95% CI: -0.34 to -0.09; p(noninferiority) < 0.001; p(superiority) = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (10% vs. 14.6%; p = 0.35), [corrected] target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). [corrected]. CONCLUSIONS: Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).

Endovascular treatment of thoracic aortic disease: mid-term follow-up.

OBJECTIVE: The aim of this study was to evaluate the mid-term follow-up in a cohort of patients with acute or chronic descending aortic disease treated by stent-graft repair. BACKGROUND: Since 1999, endovascular stent-graft placement has been reported as an alternative treatment to surgical approach for a variety of thoracic aortic diseases; however, results beyond initial short-term follow-up are not widely available for the broad range of applications. METHODS: From March 2001, 43 consecutive patients with traumatic aortic transection (group A = 16) and complicated type B aortic dissection or aneurysm (group B = 27) underwent stent-graft implantation. All patients underwent computed tomography (CT) scan as preoperative assessment and in 26 a transesophageal echo (TEE) exam was performed. RESULTS: Technically successful stent-graft deployment was achieved in all patients. No patient required surgical conversion and no cases of paraplegia occurred. The overall in-hospital mortality was 9.3%. A residual endoleak (type II) was detected in one group B patient who was managed conservatively. The mean follow-up was 29 +/- 8 months (range 10-48 months). No patient died during late follow-up after hospital discharge. At 12 months, one patient (2.5%) who had stent graft repair of an aortic dissection developed an asymptomatic type I endoleak. Three asymptomatic patients with chronic dissection had a persistent retrograde perfusion of the thoracic false lumen via a distal tear(s) in the dissection septum. CONCLUSION: Our results of stent-graft treatment of complicated and uncomplicated diseases of the descending aorta confirms that this alternative to open repair is a safe, less invasive, and relatively low risk approach. Medium-term follow-up results suggest that it is effective and durable therapy with low associated mortality and morbidity rates.

Drug-eluting versus bare metal coronary stents: long-term human pathology. Findings from different coronary arteries in the same patient.

A 71-year-old woman underwent right coronary artery (RCA) bare metal stenting during an acute myocardial infarction. Seven months later the patient received a sirolimus-eluting stent as treatment for an 80% left anterior descending coronary artery (LAD) stenosis. She remained asymptomatic until she presented with unstable angina 16 months later. Angiography demonstrated subtotal occlusion of the left obtuse marginal branch. The LAD sirolimus-eluting stent showed 0% stenosis. The RCA stent showed 30% restenosis. The left obtuse marginal branch lesion was successfully stented, but the patient suffered a fatal stroke 24 hours after the coronary intervention. At autopsy the 16-month-old LAD sirolimus-eluting stent was widely patent with a minute thrombus near the ostium of a small side branch. The stent surface appeared free of any other irregularities. Scanning light microscopy showed mild neointimal thickening. Scanning electron microscopy showed > 80% endothelialization of the stent. The 24-month-old RCA bare metal stent showed mild to moderate neointimal growth with > 90% endothelialization.