Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) represents a therapeutic concept for type B aortic dissection. Long-term outcomes and morphology after TEVAR for uncomplicated dissection are unknown. METHODS AND RESULTS: A total of 140 patients with stable type B aortic dissection previously randomized to optimal medical treatment and TEVAR (n=72) versus optimal medical treatment alone (n=68) were analyzed retrospectively for aorta-specific, all-cause outcomes, and disease progression using landmark statistical analysis of years 2 to 5 after index procedure. Cox regression was used to compare outcomes between groups; all analyses are based on intention to treat. The risk of all-cause mortality (11.1% versus 19.3%; P=0.13), aorta-specific mortality (6.9% versus 19.3%; P=0.04), and progression (27.0% versus 46.1%; P=0.04) after 5 years was lower with TEVAR than with optimal medical treatment alone. Landmark analysis suggested a benefit of TEVAR for all end points between 2 and 5 years; for example, for all-cause mortality (0% versus 16.9%; P=0.0003), aorta-specific mortality (0% versus 16.9%; P=0.0005), and for progression (4.1% versus 28.1%; P=0.004); Landmarking at 1 year and 1 month revealed consistent findings. Both improved survival and less progression of disease at 5 years after elective TEVAR were associated with stent graft induced false lumen thrombosis in 90.6% of cases (P<0.0001). CONCLUSIONS: In this study of survivors of type B aortic dissection, TEVAR in addition to optimal medical treatment is associated with improved 5-year aorta-specific survival and delayed disease progression. In stable type B dissection with suitable anatomy, preemptive TEVAR should be considered to improve late outcome. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01415804.

Predictive factors for pacemaker requirement after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been established as a treatment option for inoperable patients with symptomatic aortic valve stenosis. However, patients suffer frequently from conduction disturbances after TAVI. METHODS: Baseline, procedural as well as surface and intracardiac ECG parameters were evaluated for patients treated with TAVI and a comparison between patients requiring pacemaker with those not suffering from relevant conduction disorders were done. RESULTS: TAVI was successfully in all patients (n=45). Baseline surface and intracardiac ECG recording revealed longer PQ (197.1±51.2 msec versus 154.1±32.1 msec; p<0.001), longer AH (153.6±43.4 msec versus 116.1±31.2 msec; p<0.001) and HV interval (81.7±17.8 msec versus 56.8±8.5 msec; p<0.001) in patients with need for a pacemaker (n=23) versus control group (n=22); furthermore, 7-day follow-up analysis showed a higher prevalence of new left bundle branch block (LBBB) (87.0% versus 31.9%; p<0.001). Multivariate analysis revealed that only new LBBB, QRS duration >120 msec and a PQ interval >200 msec immediately (within 60 minutes) after implantation of the aortic valve were predictors for high-grade (type II second-degree and third-degree) AV block. Other clinical parameters as well as baseline electrocardiographic parameters had no impact on critical conduction delay. CONCLUSION: Cardiac conduction disturbances are common after TAVI. The need for pacing after TAVI is predictable by surface ECG evaluation immediately (within 60 minutes) after the procedure.

Morbidity and mortality of nonagenarians undergoing CoreValve implantation.

BACKGROUND: Nonagenarians are mostly denied from different therapeutic strategies due to high comorbidity index and risk-benefit calculation. We present the results of nonagenarians with high comorbidity index not eligible for conventional aortic valve surgery undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve system. METHODS: Our retrospective analysis include baseline parameters, procedural characteristics, morbidity, mortality as well as twelve-lead surface ECG and echocardiographic parameters which were revealed preinterventionally, at hospital discharge and at 30-day follow-up. Clinical follow-up was performed 6 months after TAVI. RESULTS: Out of 158 patients 11 nonagenarians with a mean age of 92.6 ± 1.3 years suffering from severe aortic valve stenosis and elevated comorbidity index (logistic EuroSCORE of 32.0 ± 9.5%, STS score 25.3 ± 9.7%) underwent TAVI between January 2008 and January 2011 using the third-generation percutaneous self-expanding CoreValve prosthesis. Baseline transthoracic echocardiography reported a mean aortic valve area (AVA) of 0.6 ± 0.2 cm(2) with a mean and peak pressure gradient of 60.2 ± 13.1 mmHg and 91.0 ± 27.4 mmHg, respectively. The 30-day follow up all cause and cardiovascular mortality was 27.3% and 9.1%, respectively. One major stroke (9.1%), 2 pulmonary embolisms (18.2%), 1 periprocedural (9.1%) and 1 (9.1%) spontaneous myocardial infarction occured. Life-threatening or disabling bleeding occurred in 2 cases (18.2%), and minor bleeding in 7 cases (63.6%). Mean severity of heart failure according to NYHA functional class improved from 3.2 ± 0.8 to 1.36 ± 0.5 while mean AVA increased from 0.6 ± 0.2 cm(2) to 1.8 ± 0.2 cm(2). At 6-months follow-up 8 patients (72.7%) were alive without any additional myocardial infarction, pulmonary embolism, bleeding, or stroke as compared to 30-day follow-up. CONCLUSION: Our case series demonstrate that even with elevated comorbidity index, clinical endpoints and valve-associated results are relatively favorable in nonagenarians treated with CoreValve.

Early and mid-term outcomes of percutaneous mitral valve repair with the MitraClip®: comparative analysis of different EuroSCORE strata.

AIMS: Compare mid-term outcomes after MitraClip® implantation for severe mitral regurgitation (MR) in patients categorised in different logistic EuroSCORE (LES) groups. METHODS AND RESULTS: MitraClip was implanted in 85 patients (78 ± 6 years, 48 men [56.5%]) with severe symptomatic MR. Baseline characteristics, perioperative results, mid-term survival, major adverse cerebrovascular and cardiac events (MACCE), and re-hospitalisation were compared in patients with LES <20% (n=30) and ≥ 20% (n=55). Overall LES was 24 ± 12 (range 2.5-56.3) and STS-score 12 ± 7 (range 1.2-31.2). Overall procedural success rate was 96.5% with an in-hospital mortality rate of 3.5%. Echocardiographic and clinical follow-up confirmed similar mean transmitral pressure gradient (p=0.13), MR degree (p=0.48), and NYHA Class (p=0.93). Estimated six-month survival and freedom from composite endpoint was 80.7%/77.1% in LES ≥ 20% and 90.8/86.6% in LES<20% group, respectively (p= 0.014; p=0.018). Multivariate analysis determined LES ≥ 20% (OR=8.1; 95% CI 1.002-65.186), mean transmitral gradient after intervention (OR 2.5; 95% CI 1.267-5.131) and residual MR (OR=5.1; 95% CI 1.464-17.946) as predictors for overall mortality. CONCLUSIONS: LES is a good predictor of perioperative results, and follow-up adverse outcomes after MitraClip implantation are significantly influenced by the preoperative risk profile. The presence of residual MR immediately after MitraClip therapy can exacerbate the occurrence of MACCE.

Intra coronary freshly isolated bone marrow cells transplantation improve cardiac function in patients with ischemic heart disease.

BACKGROUND: Autologous bone marrow cell transplantation (BMCs-Tx) is a promising novel option for treatment of cardiovascular disease. In this study we analyzed whether intracoronary autologous freshly isolated BMCs-Tx have beneficial effects on cardiac function in patients with ischemic heart disease (IHD). RESULTS: In this prospective nonrandomized study we treated 12 patients with IHD by freshly isolated BMCs-Tx by use of point of care system and compared them with a representative 12 control group without cell therapy. Global ejection fraction (EF) and infarct size area were determined by left ventriculography.Intracoronary transplantation of autologous freshly isolated BMCs led to a significant reduction of infarct size (p < 0.001) and an increase of global EF (p = 0.003) as well as infarct wall movement velocity (p < 0.001) after 6 months follow-up compared to control group. In control group there were no significant differences of global EF, infarct size and infarct wall movement velocity between baseline and 6 months after coronary angiography. Furthermore, we found significant decrease in New York Heart Association (NYHA) as well as significant decrease of B-type natriuretic peptide (BNP) level 6 months after intracoronary cell therapy (p < 0.001), whereas there were no significant differences in control group 6 months after coronary angiography. CONCLUSIONS: These results demonstrate that intracoronary transplantation of autologous freshly isolated BMCs by use of point of care system is safe and may lead to improvement of cardiac function in patients with IHD. REGISTRATION NUMBER: ISRCTN54510226.

Very late coronary aneurysm formation with subsequent stent thrombosis secondary to drug-eluting stent.

Drug-eluting stents have changed the practice in interventional cardiology. With the widespread use of these stents important safety concerns regarding stent thrombosis and formation of coronary artery aneurysm have been expressed. While the majority of attention was focused on stent thrombosis, the formation of coronary aneurysm was only described in anecdotal reports. We report on a patient who suffered from very late stent thrombosis in association with coronary artery aneurysm formation secondary to drug-eluting stent but not to bare-metal stent.

Impaired mobilization of CD133(+) bone marrow-derived circulating progenitor cells with an increased number of diseased coronary arteries in ischemic heart disease patients with diabetes.

BACKGROUND: The influence of the number of diseased coronary arteries on the mobilization of CD133/45(+) bone marrow-derived circulating progenitor cells (BM-CPCs) in peripheral blood (PB) in patients with ischemic heart disease (IHD) was analyzed. METHODS AND RESULTS: Mobilization of CD133/45(+) BM-CPCs by flow cytometry was measured in 120 patients with coronary 1 vessel (IHD1, n=40), coronary 2 vessel (IHD2, n=40), and coronary 3 vessel disease (IHD3, n=40), and in a control group (n=40). The mobilization of CD133/45(+) BM-CPCs was significantly reduced in patients with IHD compared to the control group (P<0.001). The mobilization of CD133/45(+) BM-CPCs was impaired in patients with IHD3 compared to IHD1 (P<0.001) and to IHD2 (P<0.001). But there was no significant difference in mobilization of CD133/45(+) BM-CPCs between the patients with IHD2 and IHD1 (P=0.35). Moreover, we found significantly reduced CD133/45(+) cell mobilization in patients with a high SYNTAX-Score (SS) compared to a low SS (P<0.001) and an intermediate SS (P<0.001). In subgroup analyzes, we observed a significantly negative correlation between levels of hemoglobin A(1c) and the mobilization of CD133/45(+) BM-CPCs (P=0.001, r=-0.6). CONCLUSIONS: The mobilization of CD133/45(+) BM-CPCs in PB is impaired in patients with IHD. This impairment might augment with increased number of diseased coronary arteries. Moreover, mobilization of CD133/45(+) BM-CPCs in ischemic tissue is further impaired by diabetes in patients with IHD.

Strategies for subacute/chronic type B aortic dissection: the Investigation Of Stent Grafts in Patients with type B Aortic Dissection (INSTEAD) trial 1-year outcome.

OBJECTIVE: Endovascular stent grafting represents a novel concept for type B aortic dissection both in the acute and subacute/chronic setting, with an unknown effect on outcomes. METHODS: In a prospective trial 140 patients with stable type B dissection were randomly subjected to elective stent-graft placement in addition to optimal medical therapy (n = 72) or to optimal medical therapy (n = 68) with surveillance (arterial pressure according to World Health Organization guidelines ≤ 120/80 mm Hg). The primary end point was 1-year all-cause mortality, whereas aorta-related mortality, progression (with need for conversion or additional endovascular or open surgical intervention), and aortic remodeling were secondary end points. RESULTS: There was no difference in all-cause mortality: cumulative survival was 97.0% ± 3.4% with optimal medical therapy versus 91.3% ± 2.1% with thoracic endovascular aortic repair (P = .16). Moreover, aorta-related mortality was not different (P = .42), and the risk for the combined end point of aorta-related death (rupture) and progression (including conversion or additional endovascular or open surgical intervention) was similar (P = .86). Three neurologic adverse events occurred in the thoracic endovascular aortic repair group (1 paraplegia, 1 stroke, and 1 transient paraparesis) versus 1 episode of paraparesis with medical treatment. Finally, aortic remodeling (with true-lumen recovery and thoracic false-lumen thrombosis) occurred in 91.3% with thoracic endovascular aortic repair versus 19.4% with medical treatment (P < .001), which is suggestive of continued remodeling. CONCLUSIONS: In survivors of uncomplicated type B aortic dissection, elective stent-graft placement does not improve 1-year survival and adverse events, despite favorable aortic remodeling.

Thoracic endovascular stent-graft therapy in aortic dissection.

PURPOSE OF REVIEW: Aortic dissection is an uncommon but highly lethal condition with a mortality rate of 1-2% per hour within the first 24 h when the ascending aorta is affected and remains a surgical domain. For the treatment of type B aortic dissection, however, endovascular techniques became available recently and are increasingly popular. This review focuses on current indications and results of thoracic endovascular stent-graft therapy in aortic dissection. RECENT FINDINGS: Uncomplicated type B aortic dissections should be managed medically and kept under surveillance for delayed expansion in 20-50% patients over 4 years. Endovascular treatment should be considered in the setting of impending or actual complications, for example, when the aortic diameter exceeds 55-60 mm, in the case of uncontrolled pain or blood pressure with evidence of malperfusion syndrome or rapid growth of the dissecting aneurysm (>1 cm/year). In both complicated acute and chronic type B aortic dissections, endovascular therapy may emerge as an attractive alternative to open surgery. However, in uncomplicated chronic type B aortic dissection, endovascular therapy failed to improve outcomes over optimal medical therapy within 2 years despite aortic remodeling. SUMMARY: Endovascular stent-graft therapy for aortic dissection is emerging with good mid-term results. Further indications, that is, aortic arch dissection and uncomplicated acute aortic dissections, are under evaluation.

Technique of interventional repair in adult aortic coarctation.

Surgical treatment of aortic coarctation has increased life expectancy and reduced mortality. Unfortunately, the average lifespan after repair remains only 35 to 50 years, and significant morbidity persists as a result of aneurysm formation, hypertension, accelerated coronary disease, and stroke. Follow-up studies have revealed restenosis rates of 30% and persistent hypertension at rest and during exercise, sometimes with compromised cardiac function. The less invasive nature of nonsurgical repair using transcatheter therapies has led to balloon angioplasty and, recently, stent implantation as an emerging concept for the treatment of aortic coarctation. This review focuses on advances in the management, current indication, and techniques of interventional repair in aortic coarctation.

Indication for percutaneous aortic valve implantation.

The incidence of valvular aortic stenosis has increased over the past decades due to improved life expectancy. Surgical aortic valve replacement is currently the only treatment option for severe symptomatic aortic stenosis that has been shown to improve survival. However, up to one third of patients who require lifesaving surgical aortic valve replacement are denied surgery due to high comorbidities resulting in a higher operative mortality rate. In the past such patients could only be treated with medical therapy or percutaneous aortic valvuloplasty, neither of which has been shown to improve mortality. With advances in interventional cardiology, transcatheter methods have been developed for aortic valve replacement with the goal of offering a therapeutic solution for patients who are unfit for surgical therapy. Currently there are two catheter-based treatment systems in clinical application (the Edwards SAPIEN aortic valve and the CoreValve ReValving System), utilizing either a balloon-expandable or a self-expanding stent platform, respectively.

Endovascular repair of thoracic aortic aneurysm.

A thoracic aortic aneurysm (TAA) is a potentially life-threatening condition with structural weakness of the aortic wall, which can progress to arterial dilatation and rupture. Today, both an increasing awareness of vascular disease and the access to tomographic imaging facilitate the diagnosis of TAA even in an asymptomatic stage. The risk of rupture for untreated aneurysms beyond a diameter of 5.6 cm ranges from 46% to 74% and the two-year mortality rate is greater than 70%, with most deaths resulting from rupture. Treatment options include surgical and non-surgical repair to prevent aneurysm enlargement and rupture. While most cases of ascending aortic involvement are subject to surgical repair (partially with valve-preserving techniques), aneurysm of the distal arch and descending thoracic aorta are amenable to emerging endovascular techniques as an alternative to classic open repair or to a hybrid approach (combining debranching surgery with stent grafting) in an attempt to improve outcomes.

Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) represents a novel concept for type B aortic dissection. Although life-saving in acute emergencies, outcomes and survival of TEVAR in stable dissection are unknown. METHODS AND RESULTS: One hundred forty patients in stable clinical condition at least 2 weeks after index dissection were randomly subjected to elective stent-graft placement in addition to optimal medical therapy (n=72) or to optimal medical therapy alone (n=68) with surveillance (arterial pressure according to World Health Organization guidelines < or =120/80 mm Hg). The primary end point was all-cause death at 2 years, whereas aorta-related death, progression (with need for conversion or additional endovascular or open surgery), and aortic remodeling were secondary end points. There was no difference in all-cause deaths, with a 2-year cumulative survival rate of 95.6+/-2.5% with optimal medical therapy versus 88.9+/-3.7% with TEVAR (P=0.15); the trial, however, turned out to be underpowered. Moreover, the aorta-related death rate was not different (P=0.44), and the risk for the combined end point of aorta-related death (rupture) and progression (including conversion or additional endovascular or open surgery) was similar (P=0.65). Three neurological adverse events occurred in the TEVAR group (1 paraplegia, 1 stroke, and 1 transient paraparesis), versus 1 case of paraparesis with medical treatment. Finally, aortic remodeling (with true-lumen recovery and thoracic false-lumen thrombosis) occurred in 91.3% of patients with TEVAR versus 19.4% of those who received medical treatment (P<0.001), which suggests ongoing aortic remodeling. CONCLUSIONS: In the first randomized study on elective stent-graft placement in survivors of uncomplicated type B aortic dissection, TEVAR failed to improve 2-year survival and adverse event rates despite favorable aortic remodeling.

Effect of antibiotic treatment in patients with postimplantation syndrome after aortic stent placement.

INTRODUCTION AND OBJECTIVES: Postimplantation syndrome that can develop after stent placement is characterized by fever, leukocytosis and an elevated C-reactive protein level or by coagulation disturbances, or by a combination of these features. It is a transient condition that frequently appears following endovascular treatment. At present, no data are available on the effect of antibiotics on postimplantation syndrome after placement of a thoracic endoprosthesis. METHODS: This prospective single-center study involved 40 patients. Of these, 20 received peri-interventional (for 24 hours) antibiotic treatment with cefuroxime, 20 mg/ kg three times per day, while 20 received prolonged (for 7 days) treatment at the same dosage. Peripheral blood samples were taken before the intervention and 6 h, 12 h, 24 h, 48 h, 3 days, 5 days, and 7 days after. RESULTS: There was no significant difference in clinical or laboratory findings between the two treatment strategies, and subsequent changes in clinical and laboratory parameters over time were similar in the two groups. All parameters returned to baseline values within 7 days. CONCLUSIONS: Prolonging antibiotic treatment beyond the day of endovascular intervention was not observed to provide any short- or long-term clinical benefit in patients with postimplantation syndrome, given that all blood samples were sterile.

[Quadricuspid aortic valve as an unusual cause of severe aortic regurgitation]. / Quadrikuspide Aortenklappe als ungewöhnliche Genese einer ausgeprägten Aortenklappeninsuffizienz.

BACKGROUND: Both, acute and chronic aortic insufficiency, can be caused by various conditions. While the acute form is often associated with an endocarditis, type A aortic dissection and trauma, one possible cause of chronic aortic insufficiency is a congenital malformation of the aortic valve. Among these malformations, the quadricuspid aortic valve is the most rare form. The diagnosis is often made by Doppler echocardiography, during cardiac surgery, or postmortem. CASE REPORT: A 44-year-old female patient presented with a 2-year history of increasing dyspnea on exertion. The physical examination revealed a diastolic heart murmur in the second right intercostal space and a blood pressure of 170/60 mmHg. Transthoracic and transesophageal Doppler echocardiography disclosed a quadricuspid aortic valve with severe aortic insufficiency. After implantation of a mechanical aortic valve, the patient was clinically well. CONCLUSION: Quadricuspid aortic valve, often associated with aortic insufficiency, is a rare condition. The diagnosis can be made by Doppler echocardiography. The special treatment should be based on objective and subjective findings. In the absence of severe aortic regurgitation or clinical signs, a medical treatment with close follow-up is justified. In case of severe aortic regurgitation or clinical signs of cardiac decompensation, surgical treatment is recommended.

Stent-graft repair in acute and chronic diseases of the thoracic aorta.

Thoracic aortic endografting has demonstrated encouraging mid-term results and attracts growing acceptance as a valuable treatment option for chronic aneurysmal disease. The emerging role of endovascular strategies for management of acute thoracic aortic pathologies is even more exciting considering the sobering results of open repair. Although it is accepted that patients at high risk for open surgery will benefit from endovascular strategies, the exact role of stent-graft interventions remains to be defined as the medical community awaits solid long-term data and better devices. While some indications and scenarios such as acute type B dissection with associated malperfusion syndrome or imminent aortic rupture have shown to benefit from stent-graft treatment, other scenarios are less settled. The current paper discusses both the established and emerging indications, as well as technical and anatomical aspects of this fascinating therapeutic option.

Current role of endovascular therapy in Marfan patients with previous aortic surgery.

The Marfan syndrome is a heritable disorder of the connective tissue which affects the cardiovascular, ocular, and skeletal system. The cardiovascular manifestation with aortic root dilatation, aortic valve regurgitation, and aortic dissection has a prevalence of 60% to 90% and determines the premature death of these patients. Thirty-four percent of the patients with Marfan syndrome will have serious cardiovascular complications requiring surgery in the first 10 years after diagnosis. Before aortic surgery became available, the majority of the patients died by the age of 32 years. Introduction in the aortic surgery techniques caused an increase of the 10 year survival rate up to 97%. The purpose of this article is to give an overview about the feasibility and outcome of stent-graft placement in the descending thoracic aorta in Marfan patients with previous aortic surgery.

Management of patients with aortic dissection.

INTRODUCTION: The incidence of acute diseases of the aorta will continue to rise as our population ages. METHODS: Selective literature review. RESULTS/DISCUSSION: At centers specializing in maximum care, it is important that a specific strategy should be established in cases of clinically suspected, acute aortic diseases, and non-invasive diagnostic measures should be taken without delay. If an acute aortic dissection is diagnosed, the necessary treatment must be provided immediately. As this disease is life-threatening, a cooperating network of referring physicians and institutions should be set up in order to ensure optimal treatment for these desperately ill patients. Acute type A aortic dissections generally require surgery, while the primary treatment of uncomplicated type B dissections is conservative and complicated type B dissections can be treated primarily with stent-graft implantation. The referring medical specialists and institutions should follow the patients closely after treatment so that any problems that may develop can be recognized and treated in timely fashion.

Rapid pacing for better placing: comparison of techniques for precise deployment of endografts in the thoracic aorta.

PURPOSE: To investigate the safety, efficacy, impact on positioning, and neurocognitive outcomes of 3 conceptually different methods of avoiding the "windsock" effect during thoracic stent-graft placement. METHODS: A retrospective review was conducted of 70 patients (48 men; mean age 63 years) who underwent elective or emergency stent-graft placement in the thoracic aorta for various pathologies. Twenty-seven patients (18 men; mean age 64+/-12 years) had stent-graft positioning during rapid right ventricular (RV) pacing at 180 to 200 beats per minute. Another 27 patients (18 men; mean age 62+/-12 years) had stent-graft placement under controlled hypotension (

Role of interventional repair in the thoracic aorta.

Endovascular treatment of chronic aneurysmatic diseases of the descending thoracic aorta has demonstrated encouraging peri-interventional mortality and morbidity and is accepted as a preferred strategy in experienced centers. The emergence of endovascular strategies for acute thoracic aortic pathologies is an even more exciting new territory for nonsurgical interventions considering the sobering results of open surgery. Although it is apparent that patients at high risk for open surgery will benefit from endovascular strategies, the exact role of stent-graft placement remains to be defined, as the community awaits solid long-term data and as devices and techniques continue to improve. While some indications and scenarios, such as acute type B dissection with associated malperfusion syndrome or imminent aortic rupture, have been shown to benefit from stent-graft treatment, others are less settled. The current paper discusses both the established and emerging indications, as well as technical and anatomical aspects of this fascinating therapeutic option.