OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

BACKGROUND: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. METHODS: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. RESULTS: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. CONCLUSIONS: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).

Sex-related differences in outcome after left atrial appendage occlusion: Insights from Europe and the EWOLUTION registry.

BACKGROUND: Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex-related differences regarding left atrial appendage occlusion (LAAO). AIMS: The aim of this study was to evaluate the sex-related differences in patients undergoing LAAO in EWOLUTION. METHODS: A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex-related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2-year clinical follow-up. Secondary Endpoints were periprocedural data and overall 2-year survival. RESULTS: Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex-related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile. CONCLUSIONS: Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long-term outcomes between women and men.

Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN.

AIMS: Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. METHODS AND RESULTS: A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy. CONCLUSIONS: Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.

Aortic annulus angulation does not attenuate procedural success of transcatheter aortic valve replacement using a novel self-expanding bioprosthesis.

The objectives of the study were to evaluate the impact of aortic angulation (AA) on success of transcatheter aortic valve replacement (TAVR) with a new generation self-expandable prosthesis (Medtronic Evolut R®). Specific anatomical conditions, such as for example the presence of a horizontal aorta with elevated AA, have seemed to pose a significant challenge for the correct positioning and consequent functioning of self-expandable TAVR prostheses. We assessed 146 patients treated with Evolut R. AA was measured at computed tomography and two groups were identified using as cutoff the mean AA value. Acute outcomes were collected and compared. AA mean value was 49.6 ± 9.4° (AA ≥ 50°: 76 and AA < 50°: 70 patients). Risk profile (Logistic euroSCORE: AA ≥ 50°: 15.7; 75% IQR: 11.1-22.1 vs. AA < 50°: 14.7; 75% IQR: 10.7-24.0; p = 0.8) was equivalent. Perioperative results were similar: valve resheathing (AA ≥ 50°: 21.0% vs. AA < 50°: 24.2%; p = 0.6), recapturing (AA ≥ 50°: 19.7% vs. AA < 50°: 25.7%; p = 0.3), fluoroscopy time (AA ≥ 50°: 11.1 IQR: 8.6-17.0 min. vs. AA < 50°: 11.0 IQR: 8.0-15.7 min.; p = 0.9), and contrast agent use (AA ≥ 50°: 99.0 ± 41.8 ml. vs. AA < 50°: 104.2 ± 38.5 ml.; p = 0.4). At discharge, moderate paravalvular leak was present in 8/76 (10.5%) of the AA ≥ 50° and 6/70 (8.6%) of the AA < 50° (p = 0.7) patients. Severe paravalvular leak, implantation of a second valve, and/or conversion to surgery did not occur. Early safety (AA ≥ 50°: 7.8% vs. AA < 50°: 5.7%; p = 0.6) was similar in the two groups. AA did not affect procedural outcomes and valve performance of the Evolut R prosthesis.

Incidence of pericardial effusion after left atrial appendage closure: The impact of underlying heart rhythm-Data from the EWOLUTION study.

INTRODUCTION: Pericardial effusion/tamponade (PE/PT) is a rare but serious complication following left atrial appendage closure (LAAC). It may be speculated that LAA contraction during sinus rhythm (SR) exerts mechanical force on the device that eventually leads to PE. We sought to determine the incidence and predictors of PE following LAAC using Watchman with special emphasis on the underlying heart rhythm during implant. METHODS AND RESULTS: From 47 centers in 13 European countries 1,020 patients underwent LAAC and data on baseline rhythm were available from 1,010 patients (mean age 73 ± 9 years, 60% male, median CHA2DS2-VASc = 4). Data were collected via electronic case report forms. A Cox proportional hazard model was calculated adjusting for multiple variables: age, gender, number of recaptures, and device oversizing. During implant, 41% and 59% of patients were in SR and atrial fibrillation (AF), respectively. PE/PT rate was significantly lower in patients implanted during AF at day 30 postimplant (n = 1; 0.2% vs. n = 6; 1.5%; P = 0.02). No PE requiring intervention occurred in the AF group compared to 5 events (1.2%) in the SR group (P = 0.01). While univariate analysis identified SR and gender as predictors for PE/tamponade, multivariate analysis only showed a statistical trend for both variables. CONCLUSION: The overall incidence of PE/PT was very low after LAAC using Watchman. Although SR was not identified as an independent predictor of PE/PT, all events requiring intervention occurred in patients with SR. It may be advisable to perform an extended echocardiographic follow-up in that patient population.

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III.

OBJECTIVES: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data. BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. METHODS: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III). RESULTS: Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in-segment and 0.39 ± 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. CONCLUSION: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.

New generation cardioverter-defibrillator lead with a floating atrial sensing dipole: Long-term performance.

OBJECTIVES: The study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany). BACKGROUND: The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock. METHODS: After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik). RESULTS: A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated. CONCLUSIONS: Although the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks.

Shocks after implantable cardioverter-defibrillator implantation in idiopathic cardiomyopathy patients: a myocardial biopsy study.

Prediction of follow-up shock is crucial to stratify patients with dilated cardiomyopathy (DCM) requiring implantable cardioverter defibrillator (ICD). The objective of the article is to assess the predictive value of endo-myocardial biopsy (EMB) towards ICD shock and follow-up mortality. A series of patients with DCM scheduled for ICD implantation underwent EMB to further determine the genesis of DCM. Presence of fibrosis and inflammation was documented and related to outcomes. A total of 240 patients were referred for ICD as primary (56%) and secondary (44%) prophylaxis. EMB showed myocardial fibrosis in 55.4%, inflammation in 55.7%, and viral genomic material in 60%. Median follow-up was 39 months (1-209). Appropriate and inappropriate shocks occurred in 29.2 and 20.4%. At logistic regression, determinants of appropriate shock were ICD indication for secondary prophylaxis (direct relationship: p = 0.009, OR 3.4, CI 1.3-8.8) and presence of inflammation at EMB (inverse relationship: p = 0.04, OR 0.4, CI 0.1-0.9). Moreover, the sole determinant of inappropriate shock was age at implant (inverse relationship: p = 0.003, OR = 0.9, CI 0.90-0.98). Overall mean estimated survival was 168 months and 5-year survival was 83%. Degree of improvement in LVEF% was the sole determinant of follow-up mortality (inverse relationship p = 0.02; HR = 0.9; CI 0.88-0.99). Present selection criteria for ICDs implant rely mainly on LVEF% that lacks sensitivity and specificity. EMB can identify the substrate of increased or reduced life-threatening arrhythmias. Presence of inflammation is a positive prognostic factor for reduced arrhythmogenic risk, independently by the ICD implantation indication.

Transcatheter aortic valve implantation with the direct flow medical prosthesis: Impact of native aortic valve calcification degree on outcomes.

OBJECTIVES: We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes. BACKGROUND: The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure. METHODS: Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II. RESULTS: Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P < 0.0001). CT perimeter derived annular diameter (group I 24.7 ± 2.1 mm vs. group II 24.8 ± 1.9; P = 0.6) and implanted prosthesis size (group I 26.1 ± 1.5 mm vs. group II 25.7 ± 1.5; P = 0.1) were similar. Hemodynamics were similar: mean gradient 16.1 ± 5.9 mm Hg (group I) vs. 17.3 ± 6.5 mm Hg (group II) (P = 0.3). Total aortic regurgitation (AR) was mild in 5.7% in group I and 20% in group II (P = 0.03). None developed moderate/severe AR. Heavy AV calcification was the sole independent determinant for mild regurgitation (P = 0.02; OR = 7; 95% CI: 1.2-37.6). Follow-up (289 days; 40-760 days) estimated survival was 88.1% (group I) and 93.8% (group II) (P = 0.3). CONCLUSIONS: Independent of AV calcification degree, adequate sizing and implantation can be achieved with the DFM®. Although higher burden of calcification increases the rate of mild AR, no patient developed moderate and severe AR. Short-term estimated survival was not influenced by calcification degree. © 2016 Wiley Periodicals, Inc.

Trans-catheter aortic valve implantation with the direct flow medical prosthesis: Single center short-term clinical and echocardiographic outcomes.

OBJECTIVES: To analyze our single center experience with the Direct Flow Medical (DFM). BACKGROUND: The DFM has been recently introduced to the market and large real world experiences are lacking. METHODS: A total of 126 patients with severe aortic valve stenosis (AVS) were treated by the same team from March 2013 to May 2015. Device success and procedural safety were classified, according to valve academic research consortium (VARC) criteria, for the entire cohort, including patients treated in the early phases of our learning curve. RESULTS: Clinical and trans-thoracic echocardiography follow-up was performed (median duration 279 days; 36-761 days). Mean age was 80.9 ± 5.5 years and median logistic Euro-SCORE was 15.9 (5.5-84.2). Cardiovascular 30-day mortality was 4.8% (6/126), device success 89.6% (113/126), and early safety 85.7% (108/126). At discharge, no aortic regurgitation (AR) was present in 85.7% and mild AR in 14.3% of the patients. Estimated 1-year follow-up survival was 91%. At follow-up, no AR was present in 87.3%, mild AR in 10.9%, and moderate AR in 1.8%. Mean gradient of 15.1 ± 6.3 mm Hg and prosthesis effective orifice area of 1.6 ± 0.6 cm2 were reported. CONCLUSIONS: In this single center experience, the DFM valve showed satisfactory clinical and hemodynamic results. Short-term follow-up confirmed the consistent clinical results, with low rates of AR and acceptable trans-prosthetic gradients and prosthetic effective orifice area. © 2016 Wiley Periodicals, Inc.

Clinical outcomes of conventional surgery versus MitraClip® therapy for moderate to severe symptomatic mitral valve regurgitation in the elderly population: an institutional experience.

BACKGROUND: The aim of this study was to compare treatment of moderate to severe symptomatic mitral regurgitation (MR) with either conventional surgery or the mitral valve edge-to-edge device (MitraClip®) in very elderly patients. The newly introduced MitraClip device has demonstrated promising acute results in treating this patient cohort. Also noteworthy is the fact that patients who otherwise would have been denied surgery are increasingly referred for treatment with the MitraClip device. We sought to review our institutional experience, comparing outcomes in both surgical and MitraClip arms of treatment in the elderly population with symptomatic MR. METHODS: From October 2008 through October 2014, 136 consecutive patients aged ≥ 80 with moderate to severe symptomatic MR were scheduled for either conventional surgery or MitraClip intervention. 56 patients ≥ 80 were operated for symptomatic MR and 80 patients ≥ 80 were treated with the mitraClip device. Patients suitable for this study were identified from our hospital database. Patients ≥80 with moderate/severe symptomatic MR treated with either conventional surgery or the MitraClip device were eligible for our analysis. We compared the surgical patient cohort with the mitraClip patient cohort after eliminating patients that did not meet our inclusion criteria. Forty-two patients were identified from the conventional cohort who were then compared with 42 patients from the mitraClip cohort. Forty-two patients (50%) underwent mitral valve repair or replacement (40.5% functional MR, 59.5% organic/mixed MR) and 42 patients (50%) underwent MitraClip intervention (50% functional MR, 50% organic/mixed MR). Associated procedures in the conventional surgical group were myocardial revascularization 38%, pulmonary vein ablation 23.8%, left atrial appendage resection 52.4% and PFO occlusion 11.9%. RESULTS: Patients who underwent MitraClip treatment were though slightly older but the differences did not attain statistical significance (mean, 82.2 ± 1.65 vs 81.7 ± 1.35 years, p = 0,100), had lower LVEF (mean, 47.6 ± 14.2 vs 53.4 ± 14.3, p = 0.072), lower logistic EuroScore II (mean, 11.3 ± 5.63 vs 12.1 ± 10.6, p = 0.655) but higher STS risk score (mean, 11.8 ± 6.7 vs 8.1 ± 5.6, p = 0.008) respectively compared to surgical patients. Procedural success was 100% vs 96% in surgery and MitraClip groups respectively. Thirty -day mortality was 7.1% vs 4.8% (p = 1.000) in surgery and MitraClip group respectively. Residual postoperative MR ≥2 at discharge was present in none of the patients treated surgically, whereas this was the case in 10 (23.8%) patients treated with the MitraClip device. At 1 year a cumulative number of four (9.52%) patients died in the surgical group vs 9 (21.4%) patients who died in the MitraClip group. CONCLUSIONS: Elderly patients presenting with moderate to severe symptomatic MR may either be treated by conventional surgery or with the MitraClip device with acceptable acute outcomes. The decision for treatment with the MitraClip device should not depend on age alone rather on cumulative risk of conventional surgery. Concomitant cardiac pathologies, often times treated simultaneously during surgery for symptomatic MR may be omitted, if patients are scheduled outright to MitraClip treatment. The effect of concomitant cardiac pathologies left untreated at the time of interventional mitral valve repair on outcome after MitraClip therapy remain widely unknown.

Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry.

AIMS: Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days. METHODS AND RESULTS: Baseline/implant data are available for 1021 subjects. Subjects in the study were at high risk of stroke (average CHADS2 score: 2.8 ± 1.3, CHA2DS2-VASc: 4.5 ± 1.6) and moderate-to-high risk of bleeding (average HAS-BLED score: 2.3 ± 1.2). Almost half of the subjects (45.4%) had a history of TIA, ischaemic stroke, or haemorrhagic stroke; 62% of patients were deemed unsuitable for novel oral anticoagulant by their physician. The device was successfully deployed in 98.5% of patients with no flow or minimal residual flow achieved in 99.3% of implanted patients. Twenty-eight subjects experienced 31 serious adverse events (SAEs) within 1 day of the procedure. The overall 30-day mortality rate was 0.7%. The most common SAE occurring within 30 days of the procedure was major bleeding requiring transfusion. Incidence of SAEs within 30 days was significantly lower for subjects deemed to be ineligible for oral anticoagulation therapy (OAT) compared with those eligible for OAT (6.5 vs. 10.2%, P = 0.042). CONCLUSION: Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure.

Transcatheter, inflatable, and fully repositionable aortic valve: Preliminary results using a modified implantation technique.

OBJECTIVES: We present our experience with an inflatable, non-metallic, fully retrievable, and repositionable transcatheter aortic valve [Direct Flow® Medical (DFM)] focusing on technical features adopted during implantation. BACKGROUND: Implantation techniques of new generation percutaneous aortic valves are still developing and with experience implementations are described. METHODS: The "low pressure" (initial valve inflation at 4 ATM, lower than the recommended 12 ATM) and the "alternate aortic curve" techniques (initial valve pulling either from the wire running on the side of the inner or from the one on the outer aortic curve) are part of our modified protocol for DFM® implantation. RESULTS: Forty-two consecutive patients underwent TAVI with DFM. The "low pressure" technique was used in all patients. In 27 (64.3%) patients the bulkiest calcifications were on the inner aortic curve side, and an inner curve technique was used to initiate valve pulling toward the annular hinge point. In the remaining 15 (35.7%) patients, an outer curve technique was used. Neither pull-through nor re-valving was reported. Valve performance showed mean gradient of 8.9 mm Hg. Mild paravalvular leak was reported in seven (16%) patients. No one experienced moderate or severe aortic insufficiency. Thirty-day mortality was 9.5% (4/42). CONCLUSION: The "low pressure technique" and the "alternate curve technique" guarantee an anatomy and patient tailored approach to achieve controlled and finely tuned valve seating.

Iatrogenic mitral valve chordal rupture during placement of an inflatable and repositionable percutaneous aortic valve prosthesis.

A case is reported of iatrogenic mitral valve chordal rupture occurring during transcatheter aortic valve implantation (TAVI) with an inflatable and repositionable valve (Direct Flow; Direct Flow Medical, Santa Rosa, CA, USA). The specific implantation technique requires initial valve advancement into the left ventricular cavity, valve inflation within the ventricular cavity, and a final finely tuned valve upward pulling through the left ventricular outflow tract until contact with the aortic annulus is achieved. During this phase of the procedure, entangling with the mitral subvalvular apparatus should be excluded, to avoid inadvertent tissue tearing and consequent mitral valve malfunction. The present patient underwent TAVI but then developed symptomatic severe mitral valve regurgitation resulting from chordal rupture. The condition was successfully treated percutaneously by implanting a Mitra-Clip.

Complicated type B aortic dissection should not be treated with uncovered stents: a lesson not yet learned.

Whenever some basic rules for endovascular aortic repair of type B aortic dissection are not followed, iatrogenic complications may develop. A 64-year-old gentleman was referred to our institution for revision of previous treatment of complex type B aortic dissection with 2 bare stents. At 3 months, the most proximal aortic bare stent had entered, via the proximal tear, the false lumen. Aortic expansion and dynamic obstruction at the level of the renal arteries had also developed. In a first step, we removed the proximal aortic bare stent surgically. Few days later, 2 covered endografts were implanted into the true lumen of the thoracic aorta with clinical success. The rationale for using endovascular treatment in patients with complicated type B aortic dissection is coverage of the entry tear with covered nonoversized endografts. Negative results are achieved whenever these very simple rules are not strictly followed.

Endovascular Repair of Descending Thoracic Aorta in Loeys-Dietz II Syndrome.

Loeys-Dietz syndrome (LDS) is an autosomal dominant disorder that is predominantly characterized by involvement of the aorta, manifesting as aneurysmal dilatation or aortic dissection. Patients with LDS manifest with spontaneous aneurysms and dissections of central and peripheral arterial beds. We present 2 cases of young male patients with Loeys-Dietz II aortopathy, who manifested with spontaneous intimal tear of descending thoracic aorta and contained aortic rupture. Both patients were managed by endovascular repair, with collaborative efforts of teams comprising interventional cardiologists and radiologists, and a vascular surgeon.

Transcatheter valve-in-ring implantation after a failed surgical mitral repair using a transseptal approach and a veno-arterial loop for valve placement.

A failure of a mitral valve repair, which includes the implantation of a mitral annuloplasty ring in the majority of cases, is associated with relevant mortality. Surgery is considered as the standard treatment for these patients. For patients who have an unacceptable high peri-surgical risk a transcatheter valve-in-ring (TVIR) procedure might be an option. Isolated case reports and small case series report on the feasibility of a TVIR implantation in mitral position. We present a case where a 29-mm Edwards Sapien valve was placed in a 32-mm Carpentier Edwards ring. To our knowledge no valve has been implanted so far in this ring size and this is the first case where a veno-arterial loop was used as guide rail for valve implantation and helped considerably to position the valve properly.

Awake extracorporeal membrane oxygenation (ECMO) as bridge to recovery after left main coronary artery occlusion: a promising concept of haemodynamic support in cardiogenic shock.

Cardiogenic shock following acute myocardial infarction is associated with high mortality rate. Different management concepts including fluid management, inotropic support, intra aortic balloon counterpulsation (IABP) and extracorporeal membrane oxygenation (ECMO) mainly in mechanically ventilated patients have been used as cornerstones of management. However, success rates have been disappointing. Few reports suggested that ECMO when performed under circumvention of mechanical ventilation, may offer some survival benefits. We herein present our experience with the use of veno-arterial ECMO as bridge to recovery in an awake and spontaneously breathing patient after left main coronary artery occlusion complicated by cardiogenic shock.

[A diagnostic maze: Cushing's disease]. / Diagnoselabyrinth: Morbus Cushing.

The case of a 78-year-old female presenting to the authors' department with heart failure with dyspnea at minimal exertion (NYHA III) as well as hypertensive blood pressure and hypokalaemia is reported. Laboratory workup showed hypercortisolism. Further workup, including imaging studies and selective catheterisation of the inferior petrosal sinus, resulted in the diagnosis of Cushing's disease caused by a pituitary microadenoma.

Hybrid aortic arch repair for complicated type B aortic dissection.

OBJECTIVE: This study analyzed the outcome of a combined endovascular and debranching procedure for hybrid aortic arch repair (HAR) in patients with complicated type B aortic dissection. METHODS: Between February 2006 and August 2012, HAR was performed in 75 consecutive patients, with retrospective analysis of a subgroup of 45 patients who underwent HAR with complicated acute (n = 10), subacute (n = 7), or chronic (n = 28) type B dissection as the underlying disease. Descriptive statistics were computed for continuous and categoric variables. The interval to death or last follow-up was estimated using the Kaplan-Meier method. RESULTS: The patients were a mean age of 59.9 ± 10.7 years (median, 59.2; range, 35-78 years). Complete supra-aortic debranching was performed in six (13%) in zone 0 (procedure time, 200 minutes; range, 185-365 minutes) and partial debranching in 39 (87%), comprising 16 (36%) in zone 1 (procedure time, 120 minutes; range, 75-250 minutes) and 23 (51%) in zone 2 (procedure time, 91 minutes; range, 70-210 minutes). Technical success was achieved in 86.7% (39 of 45). Thirty-day mortality was 4.4% (two of 45), with an in-hospital mortality of 11.1% (five of 45) as a result of three additional deaths after days 33, 35, and 111. Comparing HAR for type B dissection after complete debranching in six and partial debranching in 39, the overall in-hospital mortality was 67% (four of six) and 2.6% (one of 39), respectively. After a median follow-up of 20.8 months (range, 0.3-70 months), the overall mortality was 13.3% (six of 45), with Kaplan-Meier survival estimate of 85% at 1 year. Stroke rate was 8.8% (four of 45). Paraplegia developed in one patient (2.2%), with complete recovery after spinal drainage. Cardiac complications occurred in three patients (6.7%), pulmonary complications in 10 (22.2%), and renal insufficiency requiring dialysis developed in five (11%). Retrograde dissection occurred in one patient (2.2%) 14 days after complete debranching and zone 0 thoracic endovascular aortic repair, with fatal outcome. No bypass dysfunction was seen during follow-up. The overall early and late endoleak rates were 27% (12 of 44) and 43% (13 of 30), respectively. Eight patients (18%) required reintervention, with freedom of reintervention in 91% at 1 year and 81% at 2 years. CONCLUSIONS: HAR in zone 1 and 2 appears a viable alternative to conventional aortic arch surgery in patients with complicated type B dissection. Stroke and endoleaks remain complications that need to be addressed. Treatment of type B aortic dissection with complete supra-aortic debranching and thoracic endovascular aortic repair in zone 0, however, is associated with high mortality, which might be reduced by improved technology using branched stent grafts.