A cross-sectional study evaluating hospitalization rates for chronic limb-threatening ischemia during the COVID-19 outbreak in Campania, Italy

The expansion of coronavirus disease 2019 (COVID-19) prompted measures of disease containment by the Italian government with a national lockdown on March 9, 2020. The purpose of this study is to evaluate the rate of hospitalization and mode of in-hospital treatment of patients with chronic limb-threatening ischemia (CLTI) before and during lockdown in the Campania region of Italy. The study population includes all patients with CLTI hospitalized in Campania over a 10-week period: 5 weeks before and 5 weeks during lockdown (n = 453). Patients were treated medically and/or underwent urgent revascularization and/or major amputation of the lower extremities. Mean age was 69.2 +/- 10.6 years and 27.6% of the patients were women. During hospitalization, 21.9% of patients were treated medically, 78.1% underwent revascularization, and 17.4% required amputations. In the weeks during the lockdown, a reduced rate of hospitalization for CLTI was observed compared with the weeks before lockdown (25 vs 74/100,000 inhabitants/year; incidence rate ratio: 0.34, 95% CI 0.32-0.37). This effect persisted to the end of the study period. An increased amputation rate in the weeks during lockdown was observed (29.3% vs 13.4%; p < 0.001). This study reports a reduced rate of CLTI-related hospitalization and an increased in-hospital amputation rate during lockdown in Campania. Ensuring appropriate treatment for patients with CLTI should be prioritized, even during disease containment measures due to the COVID-19 pandemic or other similar conditions

Rationale and design of a randomized trial to assess the safety and efficacy of MultiPoint Pacing (MPP) in cardiac resynchronization therapy: The MPP Trial

BACKGROUND: Although the majority of Class III congestive heart failure (HF) patients treated with cardiac resynchronization therapy (CRT) show a clinical benefit, up to 40% of patients do not respond to CRT. This paper reports the design of the MultiPoint Pacing (MPP) trial, a prospective, randomized, double-blind, controlled study to evaluate the safety and efficacy of CRT using MPP compared to standard biventricular (Bi-V) pacing. METHODS: A maximum of 506 patients with a standard CRT-D indication will be enrolled at up to 50 US centers. All patients will be implanted with a CRT-D system (Quartet LV lead Model 1458Q with a Quadra CRT-D, Abbott) that can deliver both MPP and Bi-V pacing. Standard Bi-V pacing will be activated at implant. At 3 months postimplant, patients in whom the echocardiographic parameters during MPP are equal or better than during Bi-V pacing are randomized (1:1) to either an MPP or Bi-V arm. RESULTS: The primary safety endpoint is freedom from system-related complications at 9 months. Each patient\u27s response to CRT will be evaluated using a heart-failure clinical composite score, consisting of a change in NYHA functional class, patient global assessment score, HF events, and cardiovascular death. The primary efficacy endpoint is the proportion of responders in the MPP arm compared with the Bi-V arm between 3 and 9 months. CONCLUSION: This trial seeks to evaluate whether MPP via a single quadripolar LV lead improves hemodynamic and clinical responses to CRT, both in clinical responders and nonresponders

102-03: Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: the multipoint pacing (MPP) IDE study

Purpose: The MultiPoint™ (MPP) Pacing IDE Study assessed the safety and efficacy of the MPP feature in heart failure (HF) patients indicated for a cardiac resynchronization therapy defibrillator (CRT-D). Methods: This multicenter study enrolled and followed 506 patients with a standard CRT-D indication who were implanted with a CRT-D system (Quartet™ LV lead Model 1458Q with a Quadra CRT-D, St. Jude Medical) capable of delivering either Quadripolar Bi-Ventricular (Bi-V) pacing or MPP. Quadripolar Bi-V pacing was activated at implant. At 3 months post-implant, patients\u27 responder status was assessed, both responders and non-responders were randomized, and 1:1 randomization (Bi-V or MPP) was stratified by the patient\u27s responder status (Defined by the Clinical Composite Score). The primary safety end point was freedom from system-related complications through 9 months. The primary efficacy end point was non-inferiority of the proportion of non-responders in the MPP arm compared with the Bi-V arm between 3 and 9 months. Results: The CRT-D system was successfully implanted in 455 of the 469 attempts (97%). 381 patients were randomized to either Bi-V (n = 180) or MPP (n = 201) at 3 months. Baseline characteristics for both arms were comparable. The primary safety end point (93.2%, 97.5% lower confidence bound 90.4%) was greater than the objective performance criterion of 75% and therefore met. The primary efficacy end point was met for both intention-to-treat (ITT) and As-treated populations in 381 randomized patients (ITT, p = 0.013 and As-treated, p = 0.008, respectively). For patients (n = 52) in the MPP arm programmed with wide cathode spacing (≥ 30 mm) and the shortest intraventricular timing delay (5 ms), MPP provided significantly higher clinical responder rate up to 87% (Fig A, p = 0.003 vs. \u3c 30 mm) and converted 100% of non-responders to responders (Fig B, p = 0.006 vs. \u3c 30 mm). Conclusion: MPP was shown to be safe and effective and the study met the pre-specified hypothesis that the response to MPP is non-inferior to Quadripolar Bi-V pacing. When MPP was programmed with cathode spacing \u3e 30 mm and 5 ms LV delay, the CRT response was greatest (87%) and all non-responders were converted to responders. View largeDownload slid

Left ventricular enlargement, cardiac resynchronization therapy efficacy, and impact of MultiPoint pacing

BACKGROUND: Left ventricular (LV) epicardial pacing results in slowly propagating paced wavefronts. We postulated that this effect might limit cardiac resynchronization therapy efficacy in patients with LV enlargement using conventional biventricular pacing with single-site LV pacing, but be mitigated by LV stimulation from 2 widely spaced sites using MultiPoint pacing with wide anatomic separation (MPP-AS: ≥30 mm). We tested this hypothesis in the multicenter randomized MPP investigational device exemption trial. METHODS: Following implant, quadripolar biventricular single-site pacing was activated in all patients (n=506). From 3 to 9 months postimplant, among patients with available baseline LV end-diastolic volume (LVEDV) measures, 188 received biventricular single-site pacing and 43 received MPP-AS. Patients were dichotomized by median baseline LVEDV indexed to height (LVEDVIMedian). Outcomes were measured by the clinical composite score (primary efficacy end point), quality of life, LV structural remodeling (↑EF \u3e5% and ↓ESV 10%) and heart failure event/cardiovascular death. RESULTS: LVEDVIMedian was 1.1 mL/cm. Baseline characteristics differed in patients with LVEDVI\u3eMedian versus LVEDVI≤Median. Among patients with LVEDVI\u3eMedian, biventricular single-site pacing was less efficacious compared to patients with LVEDVI≤Median (clinical composite score, 65% versus 79%). In contrast, MPP-AS programming generated greater clinical composite score response (92% versus 65%, P=0.023) and improved quality of life (-31.0±29.7 versus -15.7±22.1, P=0.038) versus biventricular single-site pacing in patients with LVEDVI\u3eMedian. Reverse remodeling trended better with MPP-AS programming. In patients with LVEDVI\u3eMedian, heart failure event rate increased following the 3-month randomization point with biventricular single-site pacing (0.0150±0.1725 in LVEDVI\u3eMedian versus -0.0190±0.0808 in LVEDVI ≤Median, P=0.012), but no heart failure event occurred in patients with MPP-AS programming between 3 and 9 months in LVEDVI\u3eMedian. All measured outcomes did not differ in patients receiving MPP-AS and biventricular single-site pacing with LVEDVI≤Median. CONCLUSIONS: Conventional biventricular single-site pacing, even with a quadripolar lead, has reduced efficacy in patients with LV enlargement. However, the greatest response rate in patients with larger hearts was observed when programmed to MPP-AS pacing