Predictors of Crossing Failure in Femoropopliteal Lesions: The Importance of Length of the Lesion and Calcification.

BACKGROUND: Endovascular therapy is nowadays the first choice for most patients with peripheral artery disease. The most important cause of technical failure is failure to cross the lesion with a wire. In this retrospective study, we explore possible risk factors of crossing failure. METHODS: We included all consecutive patients in whom the lesion could not be crossed in the period of the January 1, 2017-January 1, 2022. The lesions of these patients were compared with patients in whom the lesion could be crossed (2:1). The following potential anatomical risk factors were compared: location of the lesion, occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium, circumferential characterization classification, and the Trans-Atlantic Inter-Society Consensus II classification. RESULTS: In 71 patients, the lesion could not be crossed; these patients were compared with 142 patients. There were significantly more patients with hypertension and hyperlipidemia in the group with crossing failure. The following factors were risk factors for crossing failure: occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium, and circumferential characterization classification. CONCLUSIONS: Although conclusions should be carefully drawn from this retrospective study, calcification and length of the lesion are associated with crossing failure in the femoropopliteal segment. The Trans-Atlantic Inter-Society Consensus II classification was the best predictor of crossing failure.

Mid-term results of "off-label" use of the Endurant stentgraft in patients with infrarenal abdominal aortic aneurysms.

OBJECTIVES: EVAR is the preferred treatment modality for patients with an infrarenal abdominal aortic aneurysm with suitable anatomy. Each manufacturer of aortic stentgrafts has specific anatomic requirements. In some patients, it is not possible to adhere to the instructions for use, but alternative treatment is also not possible. In these patients, EVAR can be performed outside instructions for use. METHODS: In this study, all consecutive patients in whom an Endurant II or IIS stentgraft was used between 1 January and 31 December were reviewed. We compared the two patient groups in whom this stentgrafts was used outside and inside instructions for use. Patients with planned adjuvant therapy, for example, chimney procedure or iliac side branches, were excluded. RESULTS: In 74 of 178 (41.6%) patients, the instructions for use were not adhered. The main reason was pathology of the aortic neck. There were more patients with type IA endoleak, this difference was borderline significant (p = .06). There were more patients with limb occlusion in the early postoperative period, but at the end of the follow-up period, the incidence was comparable. Aneurysm-related mortality and all-cause mortality were comparable in both groups. CONCLUSION: In this study, real-life experience with the Endurant II and IIS stentgraft is described. Non-adherence with instructions for use was associated with a higher risk of endoleak type IA (p = .06). In the early postoperative period, there were more patients with limb occlusion; this finding was not observed anymore at the end of the follow-up period.

Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.

BACKGROUND: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. METHODS: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis. RESULTS: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P<0.001). CONCLUSIONS: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

Incidence, Clinical Characteristics, and Impact of Absent Echocardiographic Signs in Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.

BACKGROUND: Echocardiography is the primary imaging modality for diagnosis of infective endocarditis (IE) in prosthetic valve endocarditis (PVE) including IE after transcatheter aortic valve implantation (TAVI). This study aimed to evaluate the characteristics and clinical outcomes of patients with absent compared with evident echocardiographic signs of TAVI-IE. METHODS: Patients with definite TAVI-IE derived from the Infectious Endocarditis after TAVI International Registry were investigated comparing those with absent and evident echocardiographic signs of IE defined as vegetation, abscess, pseudo-aneurysm, intracardiac fistula, or valvular perforation or aneurysm. RESULTS: Among 578 patients, 87 (15.1%) and 491 (84.9%) had absent (IE-neg) and evident (IE-pos) echocardiographic signs of IE, respectively. IE-neg were more often treated via a transfemoral access with a self-expanding device and had higher rates of peri-interventional complications (eg, stroke, major vascular complications) during the TAVI procedure (P < .05 for all). IE-neg had higher rates of IE caused by Staphylococcus aureus (33.7% vs 23.2%; P = .038) and enterococci (37.2% vs 23.8%; P = .009) but lower rates of coagulase-negative staphylococci (4.7% vs 20.0%, P = .001). IE-neg was associated with the same dismal prognosis for in-hospital mortality in a multivariate binary regression analysis (odds ratio: 1.51; 95% confidence interval [CI]: .55-4.12) as well as a for 1-year mortality in Cox regression analysis (hazard ratio: 1.10; 95% CI: .67-1.80). CONCLUSIONS: Even with negative echocardiographic imaging, patients who have undergone TAVI and presenting with positive blood cultures and symptoms of infection are a high-risk patient group having a reasonable suspicion of IE and the need for an early treatment initiation.

Clinical Outcomes after Mitral Valve Repair with the Physio II Annuloplasty Ring.

BACKGROUND: Mitral valve (MV) repair with annuloplasty is the standard of care in patients with primary degenerative mitral regurgitation (DMR). Newer generations of annuloplasty rings have been developed with the goals of closer reproduction of native annular geometry and easier implantation. This study investigates the short-term and 5-year clinical outcomes of MV repair with the Carpentier-Edwards (CE) Physio II annuloplasty ring. METHODS: This is an observational study including a total of 486 patients who underwent MV repair for DMR using the CE Physio II annuloplasty ring between 2011 and 2016. RESULTS: Mean age was 54.8 ± 12.1 years, 364 patients (74.9%) were males, and 84 patients (17.3%) presented with atrial fibrillation. Mean left ventricular ejection fraction was 62.3 ± 7.3%. Mean logistic EuroSCORE was 2.7 ± 2.4%. New York Heart Association functional class III-IV symptoms were present in 134 (27.6%) patients preoperatively. Isolated MV repair was performed via a right-sided mini-thoracotomy in 479 patients (98.6%). Concomitant procedures included ablation for atrial fibrillation in 83 patients (17.1%) and closure of atrial septum defect in 88 patients (18.1%). Median size of implanted annuloplasty rings was 34 mm (interquartile range: 34-38 mm). Mean cardiopulmonary bypass time was 116 ± 34 minutes and mean cross-clamp time was 74 ± 25 minutes. Thirty-day mortality was 0.4%. The Kaplan-Meier 4-year survival was 98.5%. Freedom from MV reoperation was 96.2 and 94.0% at 1 and 4 years. CONCLUSION: MV repair with the CE Physio II annuloplasty ring is associated with excellent midterm clinical outcome.

General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial.

BACKGROUND: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. METHODS: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. RESULTS: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8]; Pequivalence=0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8]; Pequivalence<0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8]; Pequivalence<0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9]; Pequivalence<0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7]; Pequivalence=0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8]; Pequivalence=0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]). CONCLUSIONS: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.

Management of aortic root in type A dissection: Bentall approach.

BACKGROUND: We analyzed the results of the modified Bentall procedure in a high-risk group of patients presenting with acute type A aortic dissection (ATAAD). METHODS: ATAAD patients undergoing a modified Bentall between 1996 and 2018 (n = 314) were analyzed. Mechanical composite conduits were used in 45%, and biological ones using either a bioprosthesis implanted into an aortic graft (33%) or xeno-/homograft root conduits (22%) in the rest. Preoperative malperfusion was present in 34% of patients and cardiopulmonary resuscitation required in 9%. RESULTS: Concomitant arch procedures consisted of hemiarch in 56% and total arch/elephant trunk in 34%, while concomitant coronary artery surgery was required in 20%. The average cross-clamp and cardiopulmonary bypass times were 126 ± 43 and 210 ± 76 min, respectively, while the average circulatory arrest times were 29 ± 17 min. A total of 69 patients (22%) suffered permanent neurologic deficit, while myocardial infarction occurred in 18 cases (6%) and low cardiac output syndrome in 47 (15%). The in-hospital mortality rate was 17% due to intractable low cardiac output syndrome (n = 29), major brain injury (n = 16), multiorgan failure (n = 6), and sepsis (n = 2). The independent predictors of in-hospital mortality were critical preoperative state (odds ratio [OR], 5.6; p < .001), coronary malperfusion (OR, 3.6; p = .002), coronary artery disease (OR, 2.6; p = .033), and prior cerebrovascular accident (OR, 5.6; p = .002). CONCLUSIONS: The modified Bentall operation, along with necessary concomitant procedures, can be performed with good early results in high-risk ATAAD patients presenting.

Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial.

AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). METHODS AND RESULTS: SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06]. CONCLUSION: In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.

Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients.

BACKGROUND: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here. METHODS: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany. The primary outcome was all-cause mortality at 5 years. The secondary 5-year outcomes were a composite of death, myocardial infarction, and repeat revascularization. Furthermore, the impact of complete versus incomplete revascularization was assessed. RESULTS: After a median follow-up of 5 years, 361 patients (31%) assigned to off-pump CABG and 352 patients (30%) assigned to on-pump CABG had died (hazard ratio off-pump/on-pump CABG, 1.03; 95% CI, 0.89-1.19; P=0.71). The composite outcome of death, myocardial infarction, and repeat revascularization occurred in 397 (34%) after off-pump and in 389 (33%) after on-pump CABG (hazard ratio, 1.03; 95% CI, 0.89-1.18; P=0.704). Incomplete revascularization occurred in 403 (34%) patients randomly assigned to off-pump and 354 (29%) patients randomly assigned to on-pump CABG ( P<0.001). Five-year survival rates were 72% (95% CI, 67-76) with incomplete versus 76% (95% CI, 74-80) with complete revascularization (log-rank test: P=0.02) after off-pump CABG and 72% (95% CI, 67-76) versus 77% (95% CI, 74-80) after on-pump CABG (log-rank test: P=0.03), respectively. Cox regression analysis revealed a hazard ratio incomplete/complete revascularization of 1.19 (95% CI, 1.01-1.39; P=0.04). CONCLUSIONS: In elderly patients ≥75 years of age, the 5-year survival rates and the combined outcome of death, myocardial infarction, and repeat revascularization, as well, were similar after on-pump and off-pump CABG. Incomplete revascularization was associated with a lower 5-year survival rate, irrespective of the type of surgery. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00719667.

Outcome of patients with previous coronary artery bypass grafting and severe calcific aortic stenosis receiving transfemoral transcatheter aortic valve replacement.

OBJECTIVES: To evaluate the impact of previous coronary artery bypass grafting (CABG) on early safety at 30 days and 1-year mortality in patients receiving transcatheter aortic valve replacement (TAVR). BACKGROUND: The use of TAVR in patients with previous CABG suffering from severe aortic stenosis has increased in the last years. METHODS: Consecutive TAVR patients were stratified according to previous CABG versus no previous cardiac surgery (control). All-cause 1-year mortality and early safety at 30 days were evaluated. RESULTS: In the unmatched cohort and compared to control (n = 2,364), CABG (n = 260) were younger, more often male and suffered more often from comorbidities leading to an increased STS-score (p < .001). The rate of early safety events at 30 days was comparable between CABG and control (21.2% vs. 24.6%, p = .22) with a higher mortality in CABG (9.6% vs. 5.3%, p = .005). All-cause 1-year mortality was higher in CABG compared to controls (HR 1.51 [95%-CI 1.15-1.97], p = .003). Applying Cox regression analysis, both 30-day (HR 1.57 [95%-CI 0.97-2.53], p = .067) and all-cause 1-year mortality (HR 1.24 [95%-CI 0.91-1.70], p = .174) were not significantly different between groups. After propensity-score matching, the rate of early safety events at 30 days was lower in CABG compared to controls (21.6% vs. 31.7%, p = .02). Thirty-day (9.1% vs. 7.7%, p = .596) and all-cause 1-year mortality (24.0% vs. 23.1%, p = .520, HR 1.14 [95%-CI 0.77-1.69], p = .520) were not different between groups. CONCLUSION: In patients receiving TAVR, previous CABG was not associated with an increase in periprocedural complications and all-cause 1-year mortality when adjusted for other comorbidities.

Acute Effect of Mitral Valve Repair on Mitral Valve Geometry.

BACKGROUND: The aim of this study was to quantify acute mitral valve (MV) geometry dynamic changes throughout the cardiac cycle using three-dimensional transesophageal echocardiography (3D TEE) in patients undergoing surgical MV repair (MVR) with ring annuloplasty and optional neochord implantation. METHODS: Twenty-nine patients (63 ± 10 years) with severe primary mitral regurgitation underwent surgical MVR using ring annuloplasty with or without neochord implantation. We recorded 3D TEE data throughout the cardiac cycle before and after MVR. Dynamic changes (4D) in the MV annulus geometry and anatomical MV orifice area (AMVOA) were measured using a novel semiautomated software (Auto Valve, Siemens Healthcare). RESULTS: MVR significantly reduces the anteroposterior diameter by up to 38% at end-systole (36.8-22.7 mm; p < 0.001) and the lateromedial diameter by up to 31% (42.7-30.3 mm; p < 0.001). Moreover, the annular circumference was reduced by up to 31% at end-systole (129.6-87.6 mm, p < 0.001), and the annular area was significantly decreased by up to 52% (12.8-5.7 cm2; p < 0.001). Finally, the AMVOA experienced the largest change, decreasing from 1.1 to 0.2 cm2 during systole (at midsystole; p < 0.001) and from 4.1 to 3.2 cm2 (p < 0.001) during diastole. CONCLUSIONS: MVR reduces the annular dimension and the AMVOA, contributing to mitral competency, but the use of annuloplasty rings reduces annular contractility after the procedure. Surgeons can use 4D imaging technology to assess MV function dynamically, detecting the acute morphological changes of the mitral annulus and leaflets before and after the procedure.

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

OBJECTIVES: We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. METHODS: The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. RESULTS: Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. CONCLUSIONS: The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication.

Impact of active cancer disease on the outcome of patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Patients undergoing transcatheter aortic valve replacement (TAVR) are often characterized by risk factors not reflected in conventional risk scores. In this context, little is known about the outcome of patients suffering from an active cancer disease (ACD). The objective was to determine the prevalence, clinical characteristics, perioperative outcomes, and mortality of patients with ACD undergoing TAVR compared to those with a history of cancer (HCD) and controls without known tumor disease. METHODS: TAVR patients between 02/2006 and 09/2014 were stratified according to the presence of ACD, HCD, and control. All-cause-mortality at 1-year was the primary end point. All end point definitions were subject to the Valve Academic Research Consortium II definitions. RESULTS: Overall, 1821 patients were included: 99 patients (5.4%) suffered from ACD and 251 patients (13.8%) had HCD. ACD was related to a solid organ or hematological source in 72.7% and 27.3%, respectively. Patients with ACD were more often male (P = 0.004) and had a lower logisticEuroScore I (P = 0.033). Overall rates of VARC-II defined periprocedural myocardial infarction, stroke, bleeding, access-site complications, and acute kidney injury were not different between groups. Thirty-day mortality did not differ between patients with ACD, HCD, and controls (6.1% vs 4.4% vs 7.6%, P = 0.176). All-cause 1-year mortality was higher in patients with ACD compared HCD and controls (37.4% vs 16.4% vs 20.8%, P < 0.001). ACD was an independent predictor of all-cause 1-year mortality (HR 2.10, 95%-CI 1.41-3.13, P < 0.001). CONCLUSION: The presence of ACD in patients undergoing TAVR is associated with significantly higher 1-year mortality.

Off-Pump Coronary Artery Bypass Grafting and Stroke-Exploratory Analysis of the GOPCABE Trial and Methodological Considerations.

BACKGROUND: Coronary artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG) may reduce severe adverse events including stroke. METHODS: In the German Off-Pump Coronary Artery Bypass Grafting in Elderly patients trial, the rate of major adverse cardiovascular events was compared in 2,394 elderly (≥ 75 years) patients undergoing CABG with (on-pump) or without (off-pump) cardiopulmonary bypass. This exploratory post-hoc analysis investigated the impact of surgical aortic manipulation on the rate of stroke. RESULTS: There was no significant difference in the rate of stroke within 30 days after surgery between both groups (off-pump: 2.2%; on-pump: 2.7%; odds ratio [OR]: 0.83 [0.5-1.38]; p = 0.47). Within the off-pump group, different degrees of aortic manipulation did not lead to significant different stroke rates (tangential clamping: 2.3%; OR 0.86 [0.46-1.60]; clampless device: 1.8%; OR 0.67 [0.26-1.75]; no aortic manipulation: 2.4%; OR 0.88 [0.37-2.14]). An aggregate analysis including more than 10,000 patients out of the four recent major trials also yielded comparable stroke rates for on- and off-pump CABG (off-pump: 1.4%; on-pump: 1.7%; OR 0.87 [0.64-1.20]). CONCLUSION: Within recent prospective randomized multicenter trials off-pump CABG did not result in lower stroke rates. The possible intrinsic benefit of off-pump CABG may be offset by the complexity of the operative therapy as well as the multiple pathomechanisms involved in perioperative stroke.

Preoperative Predictors and Outcome of Triple Valve Surgery in 487 Consecutive Patients.

Background Triple valve surgery (TVS) is associated with an elevated risk for operative mortality and thus remains a surgical challenge. We report our experience and results of TVS procedures, especially with respect to identification of preoperative risk factors, to improve patient selection. Methods Between December 1994 and January 2013, 487 consecutive patients (240 male, 247 female) underwent TVS at the Heart Center Leipzig, University of Leipzig. The data were prospectively collected and retrospectively analyzed. Univariate and multivariable regression analyses were performed to identify risk factors. Results The 30-day mortality was 16.1% and the long-term survival at 1 year and 5 years was 71.8% and 54.6%, respectively. Multivariable logistic regression analysis identified previous myocardial infarction to be the only significant predictor for early mortality. Age, New York Heart Association functional class IV, previous myocardial infarction, dialysis, and liver dysfunction were identified as preoperative predictors for late mortality. Furthermore, an increase of operative risk, given for each year, was observed during the study period. In contrast, 30-day mortality decreased during the observation time. Conclusion TVS is associated with a high surgical risk. Long-term survival is decreased, but acceptable for these high-risk patients. The series demonstrates that increasing surgical risk, age, and comorbidities are the future challenges in TVS.

Off-pump versus on-pump coronary-artery bypass grafting in elderly patients.

BACKGROUND: The benefits of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass in the elderly are still undetermined. METHODS: We randomly assigned patients 75 years of age or older who were scheduled for elective first-time CABG to undergo the procedure either without cardiopulmonary bypass (off-pump CABG) or with it (on-pump CABG). The primary end point was a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 30 days and at 12 months after surgery. RESULTS: A total of 2539 patients underwent randomization. At 30 days after surgery, there was no significant difference between patients who underwent off-pump surgery and those who underwent on-pump surgery in terms of the composite outcome (7.8% vs. 8.2%; odds ratio, 0.95; 95% confidence interval [CI], 0.71 to 1.28; P=0.74) or four of the components (death, stroke, myocardial infarction, or new renal-replacement therapy). Repeat revascularization occurred more frequently after off-pump CABG than after on-pump CABG (1.3% vs. 0.4%; odds ratio, 2.42; 95% CI, 1.03 to 5.72; P=0.04). At 12 months, there was no significant between-group difference in the composite end point (13.1% vs. 14.0%; hazard ratio, 0.93; 95% CI, 0.76 to 1.16; P=0.48) or in any of the individual components. Similar results were obtained in a per-protocol analysis that excluded the 177 patients who crossed over from the assigned treatment to the other treatment. CONCLUSIONS: In patients 75 years of age or older, there was no significant difference between on-pump and off-pump CABG with regard to the composite outcome of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy within 30 days and within 12 months after surgery. (Funded by Maquet; GOPCABE ClinicalTrials.gov number, NCT00719667.).

Aortic valve calcium score for paravalvular aortic insufficiency (AVCS II) study in transapical aortic valve implantation.

BACKGROUND: Transapical aortic valve implantation (TAAVI) has evolved into a routine procedure for select high-risk patients. The aim was to study the impact of native aortic valve calcification on paravalvular leaks in cardiac contrast-enhanced computed tomography (CT). METHODS: The degree and distribution of valve calcification were quantified using an Aortic Valve Calcium Score (AVCS) for each cusp separately (3mensio Valves). To reduce an artificial increase of the AVCS due to the presence of contrast material, we used thresholds for density [mean aortic density + 2*SD] and volume [0, 3, 5, 25, and 50 mm3] of calcification. RESULTS: 111 consecutive patients prior to TAAVI with preoperative CT aged 79.8 ± 5.8 years were included using the Edwards Sapien prosthesis. Paravalvular leaks were significantly associated with eccentric calcified plaques (r [Spearman] = 0.37; χ2-statistic = 15.4; P = .002), presence of LVOT calcium (r [Spearman] = 0.28; χ2-statistic = 11.3; P = .009), and the commissural gap at the anatomic ventriculo-arterial junction (r [Spearman] = 0.41-0.63; χ2-statistic = 50.8-53.0; P = .002-≤.001). There was no significant association between the total AVCS and PV leaks (r [Spearman] = 0.076; χ2-statistic = 1.471; P = .240, 120 kV, 850 hounsfield units) with no additional use of a volume-based threshold. CONCLUSION: Asymmetry of leaflet calcium distribution, LVOT calcium, and the commissural gap between leaflets were significantly associated with paravalvular leaks. Moreover, quantification of aortic valve calcification in contrast enhanced CTs shows only a weak correlation with paravalvular leakage and is therefore not reliable as a predictor, respectively.

Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial.

IMPORTANCE: Stroke remains a major predictor of mortality after transcatheter aortic valve implantation (TAVI). Cerebral protection devices might reduce brain injury as determined by diffusion-weighted magnetic resonance imaging (DWMRI). OBJECTIVE: To determine the effect of a cerebral protection device on the number and volume of cerebral lesions in patients undergoing TAVI. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, single center, blinded, randomized clinical trial in higher-risk patients with severe aortic stenosis undergoing TAVI at the University of Leipzig Heart Center. Brain MRI was performed at baseline, 2 days, and 7 days after TAVI. Between April 2013 and June 2014, patients were randomly assigned to undergo TAVI with a cerebral protection device (filter group) or without a cerebral protection device (control group). The last 1-month follow-up occurred in July 2014. INTERVENTIONS: TAVI with or without a cerebral protection device (filter system). MAIN OUTCOMES AND MEASURES: The primary end point was the numerical difference in new positive postprocedure DWMRI brain lesions at 2 days after TAVI in potentially protected territories. The first hierarchical secondary outcome was the difference in volume of new lesions after TAVI in potentially protected territories. RESULTS: Among the 100 enrolled patients, mean (SD) age was 80.0 (5.1) years in the filter group (n = 50) and 79.1 (4.1) years in the control group (n = 50), and the mean (SD) procedural risk scores (logistic EuroScores) were 16.4% (10.0%) in the filter group and 14.5% (8.7%) in the control group. For the primary end point, the number of new lesions was lower in the filter group, 4.00 (interquartile range [IQR], 3.00-7.25) vs 10.00 (IQR, 6.75-17.00) in the control group (difference, 5.00 [IQR, 2.00-8.00]; P < .001). For the first hierarchical secondary end point, new lesion volume after TAVI was lower in the filter group (242 mm3 [95% CI, 159-353]) vs in the control group (527 mm3 [95% CI, 364-830]) (difference, 234 mm3 [95% CI, 91-406]; P = .001). Considering adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening hemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy. CONCLUSIONS AND RELEVANCE: Among patients with severe aortic stenosis undergoing TAVI, the use of a cerebral protection device reduced the frequency of ischemic cerebral lesions in potentially protected regions. Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01833052.