Cryoballoon-Assisted Pulmonary Vein Isolation and Left Atrial Roof Ablation Using a Simplified Sedation Strategy without Esophageal Temperature Monitoring: No Notable Thermal Esophageal Lesions and Low Arrhythmia Recurrence Rates after 2 Years.

BACKGROUND: Atrial fibrillation (AF) ablation is increasingly effective for managing heart rhythm but poses risks like esophageal fistulas. Minimizing esophageal thermal lesions while simplifying procedures is crucial. METHODS: This prospective study involved 100 consecutive AF patients undergoing cryoballoon ablation with simplified sedation, without esophageal temperature monitoring. Patients with paroxysmal AF (Group A) received pulmonary vein isolation only, while those with persistent AF (Group B) also had left atrial roof ablation. Gastroesophageal endoscopy was performed post-procedure to detect lesions, and cardiological follow-ups were conducted at 3, 12, and 24 months. RESULTS: The cohort included 69% men, with a median age of 65.5 years. Post-ablation endoscopy was performed in 92 patients; esophageal lesions were found in 1.1% of Group A and none of Group B. GERD was diagnosed in 14% of patients, evenly distributed between groups and not linked to lesion occurrence. Gastric hypomotility was observed in 16% of patients, with no significant difference between groups. At 24 months, arrhythmia-free survival was 88% in Group A and 74% in Group B. CONCLUSION: Cryoballoon-assisted pulmonary vein isolation, with or without additional left atrial roof ablation and without esophageal temperature monitoring during a simplified sedation strategy, shows low risk of esophageal thermal injury and effective ablation outcomes.

Pulmonary Vein Isolation Followed by Biatrial Ablation of Rotational Activity in Patients with Persistent Atrial Fibrillation: Results of the Cryo-Vest Study.

Background and Aims: Noninvasive mapping allows the identification of patient-specific atrial rotational activity (RA) that might play a key role in the perpetuation of persistent atrial fibrillation (PsAF). So far, the impact of pulmonary vein isolation by cryoballoon (Cryo-PVI) on RA is unclear. Moreover, the long-term effect of periprocedural termination of AF during the ablation procedure is controversial. Methods: Noninvasive electrocardiographic mapping with a 252-electrode vest was performed in 42 patients with PsAF. After the first analysis, Cryo-PVI was performed. The RA was analyzed again and then targeted by radiofrequency catheter ablation. The primary clinical endpoint was periprocedural termination of AF. The secondary endpoint was freedom from any atrial arrhythmia >30 s during a 12-month follow-up. Results: In 33 patients (79%), right atrial RA was identified leading to biatrial ablation, and nine patients (21%) had left atrial RA only. Twelve patients (28.6%) converted from AF to sinus rhythm (SR) (Group A). Thirteen patients (30.9%) converted to atrial tachycardia (AT) (Group B). In 17 patients (40.5%), AF was not terminated by ablation (Group C). After a mean follow-up time of 13.8 months, 26 patients were free from AF and AT (61.9%). In terms of rhythm, control Group A (75%) and B (83.3%) showed higher success rates than Group C (33.3%) (p < 0.01). Cryo-PVI had no substantial impact on RA. Conclusions: The RA-based ablation approach showed acceptable success rates. Periprocedural termination of AF had a positive predictive impact on the outcome. No difference was observed between conversion to SR or to AT. Cryo-PVI had no impact on RA.

Microembolizations in the Arterial Cerebral Circulation in Patients with Atrial Fibrillation Ablation Using the Cryoballoon Technique-Protocol and Methodology of a Prospective Observational Study.

There is considerable uncertainty regarding the impact of microembolic signals (MESs) on neuropsychological abilities in patients receiving pulmonary vein isolation and beyond using the cryoballoon technique. We conducted the largest prospective observational study on this topic, providing insights into the gradual unmasking of procedure-related MESs and their impacts on neuropsychological outcomes. MESs were continuously detected periprocedurally using transcranial Doppler ultrasonography. Neuropsychological status was evaluated comprehensively using the CERAD Plus test battery, which consists of 11 neuropsychological subtests. Patients with atrial fibrillation were included in the study with an equal distribution (50:50) of paroxysmal or persistent presentations. Of 167 consecutive eligible patients, 100 were included within the study enrollment period from February 2021 to August 2022. The study, including the documentation of all follow-up visits, ended in November 2022. This paper focuses on describing the study protocol and methodology and presenting the baseline data.

Safety and Performance of the Subcutaneous Implantable Cardioverter Defibrillator Detection Algorithm INSIGHTTM in Pacemaker Patients.

BACKGROUND: The use of the S-ICD is limited by its inability to provide backup pacing. Combined use of the S-ICD with a pacemaker may be a good choice in certain situations, yet current experience concerning the compatibility is limited. The goal of this study was to determine the safety and efficacy of the S-ICD in patients with a pacemaker. METHODS: A total of 74 consecutive patients with a bipolar pacemaker were prospectively enrolled. First, surface rhythm strips were recorded in all possible pacemaker stimulation modes, to screen for T-wave oversensing (TWOS). Second, a S-ICD functional dummy was placed epicutaneously on the patient in the typical implant position. The same standardized pacing protocol was used as mentioned above, and every stimulation mode was recorded via S-ECG in all vectors. RESULTS: In 16 patients (21.6%), programmed stimulation would have led to VT/VF detection. Triggered episodes were due to counting of the pacing spike(s), QRS complex, premature ventricular contractions, and/or additional TWOS. Three cases triggered in the bipolar stimulation mode. Oversensing was associated with lung emphysema and a reduced QRS amplitude in the S-ECG. CONCLUSION: The combination of an S-ICD and a pacemaker may lead to inadequate shock delivery due to oversensing, even under programmed bipolar stimulation. Oversensing cannot be sufficiently predicted by the screening tool in pacemaker patients. Testing with an epicutaneous S-ICD dummy in all vectors and stimulation settings is recommended in patients with pre-existing pacemakers.

Incidence and outcome of peri-procedural cardiogenic shock: results from the international Euro Heart Survey PCI registry.

BACKGROUND: There is a large body of literature on acute myocardial infarction complicated by cardiogenic shock. However, very little is known about patients who are initially haemodynamically stable and develop cardiogenic shock during percutaneous coronary intervention. METHODS: A total of 47,407 consecutive patients were prospectively enrolled in the PCI Registry of the Euro Heart Survey Programme. We analysed interventions with peri-procedural complications that were classified as 'shock induced by procedure' on the case report form. Clinical and procedural characteristics as well as hospital outcomes of haemodynamically stable patients who developed cardiogenic shock during percutaneous coronary intervention were evaluated. Patients with haemodynamic instability at presentation prior to intervention were excluded. RESULTS: A total of 68 patients (0.2%) developed cardiogenic shock as a complication of percutaneous coronary intervention. The majority of cases comprised acute coronary syndrome (60.3%) with complex lesions (93.1%). Most patients had multi-vessel disease (82.1%) and an ejection fraction less than 40% (58.1%). In the multivariate analysis, left main disease (odds ratio (OR) 9.51), ST-segment elevation myocardial infarction (OR 5.31) and multi-vessel disease without left main involvement (OR 3.32) were the strongest independent predictors of peri-procedural cardiogenic shock. Among these patients procedural success was low (66.1%) and in-hospital mortality was very high (39.7%). CONCLUSIONS: In this real-world registry the rate of haemodynamically stable patients who developed cardiogenic shock during percutaneous coronary intervention was very low. Patients at a priori high risk were more likely to be affected by this complication. The in-hospital mortality rate of these patients was very high.

Left atrial roof ablation in patients with persistent atrial fibrillation using the second-generation cryoballoon: benefit or wasted time?

INTRODUCTION: It is unknown whether left atrial (LA) roof ablation combined with pulmonary vein isolation (PVI) using a second-generation cryoballoon provides additional benefit beyond that of PVI alone in patients with persistent atrial fibrillation (AF). The aim of this study was to compare arrhythmia recurrence rates after PVI alone versus PVI plus LA roof ablation. METHODS AND RESULTS: In this observational study, we analyzed 399 symptomatic patients with persistent AF treated with cryoballoon ablation. After univariate and multivariate analyses of the entire cohort, propensity score matching resulted in two groups of 86 patients each: (1) PVI plus LA roof ablation (PVI-plus group) and (2) PVI alone (PVI-only group). The primary endpoint was the first documented > 30-s arrhythmia recurrence after a 3-month blanking period. PVI was successful in all patients. A bidirectional conduction block across the LA roof was verified in 91.9% of patients in the PVI-plus group. During a median mid-term follow-up of 33 months, 21 patients (24.4%) in the PVI-plus group and 37 patients (43.0%) in the PVI-only group (P = 0.01) reached the primary endpoint. Multivariate analysis revealed AF history > 2 years (hazard ratio [HR] = 2.04, P < 0.01), LA area > 21 cm2 (HR = 2.36, P < 0.01), female sex (HR = 1.92, P = 0.02), and LA roof ablation (HR = 0.47, P < 0.01) as significant predictors of outcome. CONCLUSIONS: We observed a significant difference in arrhythmia recurrence rates between the two groups. LA roof ablation is an effective adjuvant treatment option that shows improved outcome compared with PVI alone.

[Noninvasive mapping for catheter ablation of arrhythmias using the CardioInsight™ ECG vest]. / Nichtinvasives Mapping zur Katheterablation von Arrhythmien mittels der CardioInsight™ EKG-Weste.

BACKGROUND: CardioInsight™ is a noninvasive three-dimensional mapping system technology which offers a unique method for arrhythmia characterization and localization. With a 252-lead ECG vest on the patient's torso and a noncontrast CT scan, epicardial potentials are detected and by means of reconstruction algorithms activation and phase maps are created, offering a deeper understanding of localization and mechanisms of arrhythmias including atrial fibrillation without the need for an endocardial catheter. MATERIALS AND METHODS: The system has proven to be accurate and applicable in the clinical setting of accessory pathways, premature ventricular contractions (PVC), atrial tachycardias and atrial fibrillation. Beat-to-beat analysis offers detection and thus a therapeutic approach for arrhythmias which occur only paroxysmally such as supraventricular extrasystoles, atrial bursts or PVCs. Another advantage is the simultaneous display of various heart chambers such as the left and right atrium. However, major multicenter prospective randomized data are still lacking. CONCLUSION: If in the future noninvasive mapping could be achieved with MRI and if the technology was compatible with invasive mapping systems so that catheter positioning and noninvasive maps can be merged, the authors believe that this would represent a new dimension of mapping technology and ablation strategy of arrhythmias.

Tilt testing and what you should know about it - Experience with 835 consecutive patients with syncope of unknown origin.

BACKGROUND: Numerous tilt testing protocols with and without a preceding passive phase or the administration of nitrates have already been investigated. However, a truely standardized method for the investigation does not yet exist. METHODS AND RESULTS: A total of 835 consecutive patients who underwent tilt testing between January 2005 and March 2015 were included in this study. Results of a passive tilt test (PTT), a nitrate-stimulated tilt test (NSTT) with a preceding passive phase of 20 min, or an early nitrate-stimulated tilt test (ENSTT) without a preceding passive phase were compared and analyzed retrospectively in 735 patients. In addition, a further 100 consecutive patients were prospectively randomized 1:1 to compare NSTT and ENSTT. In the retrospective analysis, 38% of the patients in the ENSTT group had a positive test response compared with 45% in the NSTT group and only 27% in the PTT group (p = 0.0002). In the prospective study, 34% of the patients had a positive test response in the ENSTT group compared with 42% in the NSTT group (p = 0.537). The mean duration to a positive test response was significantly shorter in the ENSTT group (retrospective and prospective p < 0.001). The nitrate-stimulated groups did not differ significantly with respect to the hemodynamic characteristics of a positive test response (retrospective: p = 0.773; prospective: p = 0.086). CONCLUSION: Due to the rate of positive test response being comparable to other protocols and its significantly shorter test duration, nitrate-stimulated tilt testing without a preceding passive tilt test may be favored for use in a busy clinical practice.

Baroreceptor stimulation in a patient with preexisting subcutaneous implantable cardioverter defibrillator.

BACKGROUND: Many patients with severe heart failure (HF) have an indication for baroreflex activation therapy (BAT) and an implantable cardioverter-defibrillator (ICD). Concerns about device-device interactions were addressed in a study with small sample size that concluded combined BAT and ICD therapy is safe. There are no published data, however, concerning device-device interactions between BAT and a subcutaneous ICD (S-ICD). Since BAT frequently interferes with surface electrocardiogram recordings, there are doubts about compatibility of BAT and S-ICD devices. CASE DESCRIPTION: A 54-year-old male patient with dilated cardiomyopathy and severely reduced left ventricular ejection fraction received an S-ICD after recurrent systemic infections due to a diabetic foot syndrome, ultimately associated with infective endocarditis. Since medical HF therapy could not be further optimized and the patient presented with persistent cardiac decompensations, he was evaluated for BAT. Preoperatively, the barostim was epicutaneously placed on the patient's thorax with conductive gel in order to evaluate a possible interference with the S-ICD. Positioning of the barostim in loco typico did not affect the S-ICD's sensing in any vector. Only positioning of the carotis sinus lead directly upon the S-ICD lead, which is beyond clinical relevance, lead to missensing. Subsequently, BAT was implanted with successful perioperative testing of the S-ICD: there was accurate detection of ventricular fibrillation and immediate termination via first shock delivery under maximum barostim output. CONCLUSIONS: To our knowledge, there are no other reports in which a barostim was safely implanted in a patient with a preexisting S-ICD. Until data with large patient numbers are available, individual perioperative testing is highly recommended.

Outcome of thrombus aspiration in STEMI patients: a propensity score-adjusted study.

The use of thrombus aspiration (TA) prior to primary percutaneous coronary intervention (PPCI) has undergone a radical change in intervention guidelines. The clinical implications, however, are still under scrutiny. This study investigated the clinical effects and outcome of TA before PPCI in patients with ST-segment elevation myocardial infarction (STEMI). Overall 1027 patients with STEMI were analyzed in this retrospective, propensity score-adjusted, multicenter study. The primary endpoints were in-hospital and long-term mortality. There were 418 patients in the TA group and 609 in the conventional PPCI group. The in-hospital mortality rate was significantly higher in the TA group (8.7 vs. 5.0%; P = 0.03). During long-term follow-up [median follow-up duration 689 days (IQR 405-959)] the mortality rates were similar (TA 14.3%, conventional PPCI 15.0%; P = 0.85). Survival analysis for the complete observation period revealed no significant benefit of TA [hazard ratio (HR) 1.12; 97.5% CI 0.90-0.71; P = 0.63]. There were also no significant differences between the groups in the following secondary endpoints: composite of cardiovascular death and non-fatal reinfarction at discharge (P = 0.39), post-PPCI thrombolysis in myocardial infarction flow-grade-3 (P = 0.14), left ventricular ejection fraction (P = 0.47), and non-fatal reinfarction during follow-up (P = 0.17). Rehospitalization rate (1.82 vs. 10.3%; P < 0.0001) and Canadian Cardiovascular Society (CCS) grading (P = 0.02) during follow-up were significantly lower in the TA group. In our cohort the in-hospital mortality rate was significantly higher for TA patients, but during long-term follow-up the mortality rates did not differ. The incidence of rehospitalization and CCS grading were lower in the TA-treated patients.

Applicability of a Novel Formula (Bogossian formula) for Evaluation of the QT-Interval in Heart Failure and Left Bundle Branch Block Due to Right Ventricular Pacing.

BACKGROUND: The presence of left bundle branch block (LBBB) due to right ventricular pacing represents a particular challenge in properly measuring the QTc interval. In 2014, a new formula for the evaluation of QT interval in patients with LBBB was reported. METHODS: 145 patients with implantable cardioverter defibrillator were included in this prospective multicenter observational study. Inclusion criteria were: no permanent right ventricular stimulation, an intrinsic QRS interval of <120 ms, and reduced left ventricular function. 12-lead electrocardiogram recordings during intrinsic rhythm and during right ventricular threshold testing were performed. After LBBB correction using the reported Bogossian formula, the QTc interval was evaluated with Bazett's formula. The corrected QTc interval was compared in each patient with the QTc interval during intrinsic rhythm. All measurements were performed by an experienced electrophysiologist and a trainee who worked independently and in a blinded manner. RESULTS: 74 patients (65 ± 13 years; male n = 42) with apical and 71 patients (68 ± 11 years; male n = 42) with nonapical right ventricular pacing were included in this study. The mean left ventricular ejection fraction was 40 ± 13%. The QTc interval was determined to be 461 ± 34 ms (modified by Bogossian's formula) in paced and 436 ± 34 ms in intrinsic rhythm. The QTc interval was overestimated by ΔQTc of 25 ± 21 ms (mean deviation 5.7%) when using the Bogossian formula. CONCLUSION: The novel Bogossian formula seems to be a reliable tool for QTc interval evaluation in patients with heart failure and right ventricular pacing. However, a slight overestimation of the QT-interval must be respected.

Endocarditis after interventional repair of the mitral valve: Review of a dilemma.

BACKGROUND: The MitraClip procedure can be an alternative treatment option for patients with high surgical risk for whom surgical treatment is contraindicated. Patients with prosthetic material have an increased risk for infective endocarditis. HYPOTHESIS: Incidence, treatment and outcome of patients with endocarditis after interventional mitral valve repair are not known. METHODS: We searched for articles using PubMed using the terms "interventional mitral valve repair", "mitraclip" and "endocarditis". We have also searched for case reports in major congresses. Furthermore, we report two cases. RESULTS: Four cases of IE after MitraClip were found in addition to our cases. The leading cause is a bacterial infection, typically with staphylococcal bacteria. Approximately two thirds of these patients underwent surgery. Short-term outcome seems to be reasonable for these patients. During the early postoperative period and if Staphylococcus aureus can be cultivated mortality seems to be significantly elevated. CONCLUSION: IE after MitraClip procedure is a dilemma. While surgical bail-out seems to be the favorable treatment option, patients were rejected conventional surgery in first place due to their high operative risk. Best treatment recommendation must be made on an individual basis. Predisposing factors should be conscientiously addressed prior to the procedure.

Safety of the Wearable Cardioverter Defibrillator (WCD) in Patients with Implanted Pacemakers.

BACKGROUND: The wearable cardioverter defibrillator (WCD) is an important approach for better risk stratification, applied to patients considered to be at high risk of sudden arrhythmic death. Patients with implanted pacemakers may also become candidates for use of the WCD. However, there is a potential risk that pacemaker signals may mislead the WCD detection algorithm and cause inappropriate WCD shock delivery. The aim of the study was to test the impact of different types of pacing, various right ventricular (RV) lead positions, and pacing modes for potential misleading of the WCD detection algorithm. METHODS: Sixty patients with implanted pacemakers received the WCD for a short time and each pacing mode (AAI, VVI, and DDD) was tested for at least 30 seconds in unipolar and bipolar pacing configuration. In case of triggering the WCD detection algorithm and starting the sequence of arrhythmia alarms, shock delivery was prevented by pushing of the response buttons. RESULTS: In six of 60 patients (10%), continuous unipolar pacing in DDD mode triggered the WCD detection algorithm. In no patient, triggering occurred with bipolar DDD pacing, unipolar and bipolar AAI, and VVI pacing. Triggering was independent of pacing amplitude, RV pacing lead position, and pulse generator implantation site. CONCLUSION: Unipolar DDD pacing bears a high risk of false triggering of the WCD detection algorithm. Other types of unipolar pacing and all bipolar pacing modes do not seem to mislead the WCD detection algorithm. Therefore, patients with no reprogrammable unipolar DDD pacing should not become candidates for the WCD.

Barostim Implantation with Ipsilateral Carotid Endarterectomy as a One-Stage Procedure.

Clinical trials have demonstrated significant and lasting reductions in arterial pressure from baroreflex activation therapy (BAT), resulting from electrical stimulation of the carotid sinus in patients with resistant arterial hypertension. Significant carotid atherosclerosis, however, has been a contraindication for ipsilateral implantation due to a potentially increased risk of periprocedural stroke and uncertain antihypertensive efficacy. Here, we describe the first case in which BAT was applied safely and effectively in a patient with distinct cerebral arteriosclerosis after ipsilateral carotid endarterectomy as a one-stage procedure without neurologic complications. BAT resulted in satisfactory blood pressure levels despite distinct cerebral atherosclerosis after an 18-month follow-up period.

Rescue baroreflex activation therapy after Stanford B aortic dissection due to therapy-refractory hypertension.

Clinical trials have demonstrated significant and durable reduction in arterial pressure from baroreflex activation therapy (BAT) in patients with resistant arterial hypertension. There is a lack of data, however, concerning the use of BAT in a rescue approach during therapy-refractory hypertensive crisis resulting in life-threatening end-organ damage. Here, we describe the first case in which BAT was applied as a rescue procedure in an intensive care setting after ineffective maximum medical treatment. A 34-year-old male patient presented with Stanford B aortic dissection and hypertensive crisis. The dissection membrane extended from the left subclavian artery down to the right common iliac artery, resulting in a total arterial occlusion of the right leg. After emergency thoracic endovascular aortic repair and femorofemoral crossover bypass, the patient developed a compartment syndrome of the right lower limb, ultimately leading to amputation of the right leg above the knee. Even under deep sedation recurrent hypertensive crises of up to 220 mm Hg occurred that could not be controlled by eight antihypertensive drugs of different classes. Screening for secondary hypertension was negative. Eventually, rescue implantation of right-sided BAT was performed as a bailout procedure, followed by immediate activation of the device. After a hospital stay of a total of 8 weeks, the patient was discharged 2 weeks after BAT initiation with satisfactory blood pressure levels. After 1-year follow-up, the patient has not had a hypertensive crisis since the onset of BAT and is currently on fourfold oral antihypertensive therapy. The previously described bailout procedures for the treatment of life-threatening hypertensive conditions that are refractory to drug treatment have mainly comprised the interventional denervation of renal arteries. The utilization of BAT is new in this emergency context and showed a significant, immediate, and sustained reduction of blood pressure levels after activation. To our knowledge, we report the first case of an immediate activation of a barostim while the device is usually not activated before 2 to 4 weeks after implantation to allow time for the surgical site to heal. During the follow-up period, the healing process was not impaired, and a significant, immediate, and sustained reduction of blood pressure levels after activation could be observed. This treatment option offers maximum adherence to antihypertensive therapy to avoid future cardiovascular end-organ damage and possibly reduce antihypertensive medication and undesirable side effects.

Use and outcome of thrombus aspiration in patients with primary PCI for acute ST-elevation myocardial infarction: results from the multinational Euro Heart Survey PCI Registry.

The clinical benefit of thrombus aspiration (TA) in patients presenting with acute ST-elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) is not well defined. Furthermore, there is a large variation in the use of TA in real-world registries. Between 2005 and 2008, a total of 7146 consecutive patients with acute STEMI undergoing primary PCI were prospectively enrolled into the PCI Registry of the Euro Heart Survey Programme. For the present analysis, patients treated additionally with TA (n = 897, 12.6 %) were compared with those without TA (n = 6249, 87.4 %). Patients with hemodynamic instability at initial presentation (15.1 vs. 11.0 %; p < 0.001) and resuscitation prior to PCI (10.4 vs. 7.4 %; p = 0.002) were more frequently treated with TA. TIMI flow grade 0/1 before PCI was more often found among those with TA (73.5 vs. 58.6 %; p < 0.001). After adjustment for confounding factors in the propensity score analysis, TA was not associated with improved in-hospital survival (risk difference -1.1 %, 95 % confidence interval -2.7 to 0.6 %). In this European real-world registry, the rate of TA use was low. Hemodynamically unstable patients were more likely to be treated with TA. Consistent with the results of the TASTE study and the TOTAL trial, TA was not associated with a significant reduction in short-term mortality.

Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion.

OBJECTIVE: This study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions. BACKGROUND: Everolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited. METHODS: Patients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score. RESULTS: A total of 23 patients were included. Mean age was 60.4 ± 9.0 years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7 ± 1.0. Median procedure time was 70 min (54-85), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1-30.0). A total of 64 BVSs were implanted with a mean number of 2.8 ± 1.0 BVSs per patient, a mean total BVS length of 64.8 ± 24.2 mm per lesion, and a mean BVS diameter of 3.1 ± 0.2 mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5-214.5) days one in-scaffold thrombosis was noted 4 days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred. CONCLUSION: These results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases.

Short-term outcome of patients with ST-segment elevation myocardial infarction (STEMI) treated with an everolimus-eluting bioresorbable vascular scaffold.

OBJECTIVES: To evaluate safety and efficacy of the everolimus-eluting bioresorbable scaffold (BVS) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: According to the current guidelines, drug-eluting stents are the treatment of choice in patients with STEMI. BVS represents a new technology capable to restore the native vessel vasomotion and potentially avoiding long-term limitations such as stent thrombosis. METHODS: From October 2012 to May 2013, patients with evidence of STEMI eligible for BVS implantation were included in this study. Exclusion criteria were not defined. RESULTS: A total of 25 patients, respectively 31 lesions, were treated. Procedural success was achieved in 97%. Two major adverse cardiac events occurred during hospitalization and follow-up: one patient with cardiogenic shock at the index procedure subsequently died. One patient suffered from instable angina with need for interventional revascularization of a previously untreated vessel. One target vessel failure as a consequence of an intra-procedural dissection was seen. However, no target lesion failure was noted. During 132.7 ± 68.7 days of follow-up none of the patients died. CONCLUSION: Our findings suggest that implantation of BVS in STEMI patients is feasible in this small cohort of highly selected patients. Further evaluation in randomized-controlled trials is needed.