Domenico Sergi

Clinical and procedural outcome of patients implanted with a quadripolar left ventricular lead: Early results of a prospective multicenter study

BACKGROUND Recent studies suggest that cardiac resynchronization therapy (CRT) with a quadripolar left ventricular (LV) lead results in low rates of dislocation and phrenic nerve stimulation (PNS) acutely and at short-term follow-up. Confirmation of these results by long-term observational studies is needed. OBJECTIVE To evaluate the long-term procedural and clinical outcomes of CRT patients implanted with a quadripolar LV lead. METHODS A total of 154 consecutive heart failure patients (79% men, age 68 ± 10 years) having CRT implantation attempts with a quadripolar LV lead were included in this observational registry. Demographic and clinical data were preoperatively collected, and patients were followed up for at least 6 months. RESULTS The overall implant success rate after coronary sinus cannulation was 97.4%. Mean overall duration and fluoroscopy time of successful procedures was 112 ± 22 and 16 ± 8 minutes, respectively, while 17 ± 13 minutes were necessary for the LV lead placement. After implant, the conventional bipolar configuration was used as the final pacing configuration in 33.3% of the patients. Four lead dislodgments (requiring reoperation) and 9 clinical PNS were reported during follow-up; reprogramming of the device was sufficient to prevent PNS in all patients. Once placed, the LV lead remained stable with excellent pacing thresholds during follow-up (15 ± 5 months). Overall, there were 71.3% CRT responders as assessed by 6-month echocardiography, and 66% improved at least 1 New York Heart Association class. CONCLUSION Over the longer term, CRT with the quadripolar LV lead is associated with excellent pacing thresholds, low rates of dislocations, and PNS.

The outcome of intra-aortic balloon pump support in acute myocardial infarction complicated by cardiogenic shock according to the type of revascularization: A comprehensive meta-analysis

AIMS Despite the recommendations of the current guidelines, scientific evidence continue to challenge the effectiveness of intra-aortic balloon pump (IABP) in acute myocardial infarction (AMI) complicated by cardiogenic shock. Moreover, 2 recent meta-analyses showed contrasting results. The aim of this study is to test the effect of IABP according to the type of therapeutic treatment of AMI: percutaneous coronary intervention (PCI), thrombolytic therapy (TT), or medical therapy without reperfusion. Articles published from January 1, 1986, to December 31, 2012, were collected and analyzed by meta-analysis. METHODS AND RESULTS We evaluated the IABP impact on inhospital mortality, on safety end points (stroke, severe bleeding) and long-term survival, using risk ratio (RR) and risk difference (RD) estimates. We found that the risk of death was (i) not significantly different between the IABP and control groups (RR 0.95, P = .52; RD -0.04, P = .28), (ii) significantly reduced in the TT subgroup (RR 0.77, P < .0001; RD -0.16, P < .0001), and (iii) significantly increased in the PCI subgroup (RR 1.18, P = .01; RD 0.07, P = .01). There were no significant differences in secondary end points (P, not significant). In addition, we compared the meta-analyses collected over the same search period. CONCLUSION The results show that IABP support is significantly effective in TT reperfusion but is associated with a significant increase of the inhospital mortality with primary PCI. The comparison of the meta-analyses demonstrates the key role of analysing primary clinical treatments to avoid systematic errors.

Impact of continuous intracardiac ST-segment monitoring on mid-term outcomes of ICD-implanted patients with coronary artery disease. Early results of a prospective comparison with conventional ICD outcomes

Background Although myocardial ischaemia monitored by some implantable cardioverter-defibrillators (ICDs) might improve patient care, the clinical usefulness of this technology has not yet been validated. Objective To investigate the potential impact of ICD-based ischaemia monitoring on clinical care and patient management of ICD recipients. Design Prospective, controlled, non-randomised study. Setting Single-centre, university hospital. Patients Consecutive patients with known coronary artery disease, followed up for at least 6 months. Interventions Patients implanted with either an ICD providing continuous intracardiac ST monitoring (n=53; ST group) or with an ICD without this capability (n=50). Main outcome measures Major cardiovascular events, appropriateness of ST-shift episodes and unscheduled device-related visits. Results During follow-up (15.4±8.4 months), one patient experienced ST-shift events confirmed by angiography to be related to myocardial ischaemia. Myocardial infarction was a rare event and occurred in one patient (ST group) who had an ST-elevation myocardial infarction 3 weeks after the implant, but at this time the algorithm had not yet been activated. In the ST group, seven patients had one or more episodes of false-positive ST events (median 9, range 1–90). The programmable features of the device helped overcome the problem in six patients. Among patients with a remote monitoring system, unscheduled outpatient visits were significantly increased in the ST group (17 vs 4; p=0.032). Conclusions Although, this study was underpowered by the small number of acute ischaemic events, ICD-based ST monitoring failed to provide a benefit over ICDs without this capability and increased unscheduled evaluations in patients with remote follow-up. The sensitivity and specificity of the algorithm still require validation.

Predictive value of fragmented QRS in primary prevention implantable cardioverter defibrillator recipients with left ventricular dysfunction.

Introduction In primary prevention implantable cardioverter defibrillator (ICD) patients, the incidence of appropriate ICD therapy is relatively low, prompting better risk stratification. Fragmented QRS (fQRS) on a 12-lead ECG has been associated with adverse outcomes. The aim of this study was to evaluate the prognostic value of fQRS in ICD recipients. Methods Consecutive ICD patients implanted at our institution for primary prevention of sudden cardiac death (SCD) were retrospectively evaluated. Patients were divided in two groups based on the presence or the absence of fQRS on the ECG obtained before ICD implantation. The endpoint of the study was all-cause mortality or the occurrence of any appropriate ICD-delivered therapy, whether shock or antitachycardia pacing. Results Among 394 ICD recipients (334 men, age 66.4 ± 11.0), fQRS was observed in 103 patients (26.1%). There were 189 patients (48.0%) with wide QRS at the time of implantation. Among these patients, fQRS was found in 29 individuals (28.2%). Patients in fQRS(+) group were more likely to have coronary artery disease and a lower QRS duration than those without fQRS. During a mean follow-up of 26.3 ± 17.5 months, mortality or ICD therapy were 19.4 and 22.4%, respectively, for fQRS(+) patients, and 15.2 and 22.8% for fQRS(−) patients (P = NS). By Kaplan–Meier analysis, event-free survival was similar in the two groups. Conclusion In ICD recipients for primary prevention of SCD, fQRS is not helpful in selecting a subgroup of patients who benefit from prophylactic ICD implantation.

Lack of intra-aortic balloon pump effectiveness in high-risk percutaneous coronary interventions without cardiogenic shock: a comprehensive meta-analysis of randomised trials and observational studies.

BACKGROUND Although controversial, using prophylactic intra-aortic balloon pump (IABP) in patients undergoing high-risk percutaneous coronary intervention (PCI) has been reported to be effective by numerous registry studies. However, conflicting findings were observed in observational studies (Obs.) and randomised controlled trials (RCTs). OBJECTIVE The purpose of this meta-analysis was to assess the impact of IABP on in-hospital deaths, major adverse cardiovascular events (MACCE), access-site complications and stroke in high-risk PCI cases from Obs. and RCTs published from 1st January, 1990 to 31st March, 2012 and indexed in PubMed. METHODS AND RESULTS We retrieved 1125 studies from the database; 11 studies compared the effects of IABP support, i.e., prophylactic administration (P-IABP) vs. no support (No-IABP), in high-risk patients undergoing PCI. These studies were included in the meta-analysis. We then calculated risk ratios (RRs) and risk differences (RDs) between the two groups of patients (P-IABP vs. No-IABP). We did not observe significant in-hospital mortality, MACCE, access-site complications or stroke differences in the RRs and RDs of the two groups. CONCLUSIONS The results suggest that PCI plus P-IABP support does not result in reduced in-hospital mortality or MACCE nor in significant higher access-site complications or stroke incidence compared with PCI alone in patients at high risk for peri-procedural PCI complications.

Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis

AIM To assess the impact of percutaneous cardiac support in cardiogenic shock (CS) complicating acute myocardial infarction (AMI), treated with percutaneous coronary intervention. METHODS We selected all of the studies published from January 1(st), 1997 to May 15(st), 2015 that compared the following percutaneous mechanical support in patients with CS due to AMI undergoing myocardial revascularization: (1) intra-aortic balloon pump (IABP) vs Medical therapy; (2) percutaneous left ventricular assist devices (PLVADs) vs IABP; (3) complete extracorporeal life support with extracorporeal membrane oxygenation (ECMO) plus IABP vs IABP alone; and (4) ECMO plus IABP vs ECMO alone, in patients with AMI and CS undergoing myocardial revascularization. We evaluated the impact of the support devices on primary and secondary endpoints. Primary endpoint was the inhospital mortality due to any cause during the same hospital stay and secondary endpoint late mortality at 6-12 mo of follow-up. RESULTS One thousand two hundred and seventy-two studies met the initial screening criteria. After detailed review, only 30 were selected. There were 6 eligible randomized controlled trials and 24 eligible observational studies totaling 15799 patients. We found that the inhospital mortality was: (1) significantly higher with IABP support vs medical therapy (RR = +15%, P = 0.0002); (2) was higher, although not significantly, with PLVADs compared to IABP (RR = +14%, P = 0.21); and (3) significantly lower in patients treated with ECMO plus IABP vs IABP (RR = -44%, P = 0.0008) or ECMO (RR = -20%, P = 0.006) alone. In addition, Trial Sequential Analysis showed that in the comparison of IABP vs medical therapy, the sample size was adequate to demonstrate a significant increase in risk due to IABP. CONCLUSION Inhospital mortality was significantly higher with IABP vs medical therapy. PLVADs did not reduce early mortality. ECMO plus IABP significantly reduced inhospital mortality compared to IABP.

Hemodynamic patterns of residual interatrial communication after transcatheter MitraClip repair.

Aims We sought to assess the hemodynamic sequel and the therapy adopted in patients treated with MitraClip system, who experienced a persistent interatrial communication (IAC) after the procedure. Methods From January 2012 to March 2013, 28 consecutive patients (mean age 74 ± 8 years) underwent transcatheter MitraClip repair, as part of an ongoing prospective study to assess the IAC. Results Acute procedural success was 100% and a 30-days survival of 97% was reported. Immediately after the procedure, a residual IAC was present in all patients with an average diameter of 0.51 ± 0.39 cm. At 30 days, IAC was detected in 81% of patients with a diameter of 0.45 ± 0.31 cm (P = 0.53). To date, three patients developed different hemodynamic impairment secondary to the residual IAC, requiring percutaneous closure of the defect. Conclusion Anatomic and hemodynamic criteria for early recognition of harmful residual IAC have to be identified, in order to select those patients who are benefited the most from atrial septal defect closure.

Device monitoring of heart failure in cardiac resynchronization therapy device recipients: a single-center experience with a novel multivector impedance monitoring system.

Objectives We investigated the performance of a new intrathoracic multivector impedance monitoring system for the prediction of heart failure events in consecutive device-implanted patients. Methods Eighty heart failure patients implanted with biventricular defibrillators with multivector impedance monitoring capability were prospectively enrolled. Clinical heart failure status and impedance data were assessed during follow-up and if patients presented with an alert or heart failure deterioration. Results During follow-up (8.0 ± 4.4 months), 56 events of device alert for fluid index increase were identified in 29 patients, and a total of 39 heart failure events (defined by worsening of heart failure signs and symptoms) occurred in 23 patients. The sensitivity and positive predictive value (PPV) for heart failure deterioration was 61.5 and 42.9%, respectively. False-positive alerts occurred in 23 of 80 patients (28.8%), for an episode rate of 0.60 a year. Among all clinical heart failure events, decompensation caused hospitalization in 13 cases (33.3%), seven of them were preceded by an alert condition (53.8%) resulting in a sensitivity of 53.8% and a PPV of 17.9%. Conclusion The present study confirms the feasibility and clinical usefulness of this novel multivector impedance monitoring system. It would be worthwhile to perform larger studies to assess its actual clinical value in heart failure patients.

Transcatheter aortic valve implantation through distal axillary artery: novel option for vascular access.

Aims We describe an alternative access approach for patients undergoing transcatheter aortic valve implantation (TAVI) using surgical cut down of the distal axillary artery, in cases wherein transfemoral access is not feasible. Methods From January 2012 to July 2013, 61 patients (59% men; mean age 81 ± 8 years) underwent TAVI at our institution. The mean logistic EuroSCORE and EuroSCORE II were 36 ± 24 and 14 ± 10, respectively. We assessed device success, 30-day safety and clinical efficacy using VARC II criteria. Results TAVI was performed with the CoreValve Revalving System (CRS) (Medtronic Inc., Minneapolis, Minnesota, USA) in all cases, using transfemoral approach in 57 patients and distal trans-axillary route in four patients. A device was successfully implanted in 94%, without any major intraprocedural complications. One case of acute kidney disease, four cases of minor vascular complication and two cases of life-threatening bleeding occurred after the procedure for pericardial bleeding requiring pericardiocentesis. Permanent pacemaker was implanted in 26% of patients. There was no instance of in-hospital mortality, while two deaths (3%) occurred in the first 30 days. The total procedure time (skin-to-skin) was longer in the trans-axillary group secondary to surgical management of access site (P = 0.027), whereas revalving and fluoroscopy time were similar (P = 0.95 and P = 0.83, respectively). Conclusion The location and anatomical relations of the distal axillary artery make it a safer, reproducible and operator friendly access option for TAVI.

Percutaneous closure of patent foramen ovale with Atriasept II device in nickel allergic patients.

There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity. Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure.