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.

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.

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.